Table of Contents

1. Introduction

2. Levels of evidence and types of indications

2.1. Levels of evidence

2.2. Classes of recommendations

3. The Heart Team

Recommendations

4. Frailty assessment

Recommendations

5. Indications for TAVI

Recommendations

6. Contraindications for TAVI

Recommendations

7. The role of aortic valvuloplasty

Recommendations

8. The TAVI procedure

9. Role of CT angiography in prosthesis sizing and vascular access selection

9.1. Prosthesis sizing:

9.2. Vascular access selection:

10. Types of TAVI prostheses

10.1. Self-expanding valves

10.2. Balloon-expandable valves

11. Vascular accesses

11.1. Transfemoral access

11.2. Subclavian/axillary access

11.3. Carotid access

11.4. Transcaval access

Recommendations

12. Complications of TAVI

12.1. Paravalvular regurgitation

12.2. Conduction disturbances

12.3. Vascular access

12.4. Stroke

12.5. Coronary obstruction

13. Care after implantation

13.1. Antithrombotic therapy

13.2. Coronary access

13.3. Follow-up of TAVI patients

14. Special situations

14.1. TAVI in bicuspid aortic valve

Recommendations

14.2. TAVI in aortic regurgitation

15. Acknowledgments

References

1. Introduction

Severe aortic valve stenosis (AS), defined by an aortic valve area < 1 cm² or a body surface area < 0.6 cm²/m², is one of the leading valve diseases globally, with an estimated prevalence of 2-9% in patients over 75 years old1, 2. This prevalence is increasing due to progressive population aging. In this context, considering the deleterious clinical impact of this disease in terms of morbidity and mortality, advanced tools and technologies have been developed in recent years. Not only do they allow for a more precise and early diagnosis, but they also favor the tailoring of therapeutic strategies to each clinical case.

Since pharmacological medical treatment does not modify the natural progression of AS, this disease requires a surgical/interventional approach. Traditionally, surgical aortic valve replacement (SAVR) has been the strategy of choice. However, in recent decades, transcatheter aortic valve implantation (TAVI) has become the preferred therapeutic alternative for various age groups and surgical risk subgroups.

The clinical benefit derived from TAVI has raised considerable interest among different scientific societies. This has resulted in a substantial body of scientific evidence generated over the past few years supporting the adoption of TAVI in various clinical contexts. Consequently, having an up-to-date compendium of available evidence to improve decision-making accuracy and optimize patient care is of the utmost importance.

In 2016, the Argentinian College of Interventional Cardiologists (CACI) published its first “Consensus on Percutaneous Aortic Valve Implantation,” which was updated in 20193. Since this latest update, and considering the significant clinical benefits of this strategy, new scientific evidence has emerged regarding the clinical implications of TAVI in previously unexplored scenarios. Additionally, new valve prostheses have been introduced and valuable information has been gathered on innovative implantation techniques aimed at reducing adverse clinical events associated with the procedure.

Given the ongoing evolution of TAVI, the aim of this update is to provide the most updated information based on the related available scientific evidence.

2. Levels of evidence and types

of indications

For this update of the CACI TAVI expert consensus, we have adopted both the levels of evidence and the classes of recommendations used in the European Society of Cardiology (ESC) guidelines.

2.1. Levels of evidence:

• Level A: Consistent data derived from multiple randomized clinical trials or meta-analyses.

• Level B: Data derived from a single randomized clinical trial or high-quality non-randomized studies.

• Level C: Consensus of opinion of the experts and/or small studies, retrospective studies, registries.

2.2. Classes of recommendations:

• Class I: Evidence and/or general agreement that a given treatment or procedure is beneficial, useful, and effective. TAVI is recommended or indicated.

• Class II: Conflicting evidence or divergence of opinion about the usefulness/efficacy of the treatment or procedure.

- IIa: Weight of evidence/opinion is in favor of its use.

- IIb: Usefulness/efficacy is less well established.

• Class III: Evidence or general agreement that the given treatment or procedure is not useful/effective, and in some cases may be harmful.

This structure ensures that recommendations for the use of TAVI will be based on the best available evidence and a clear consensus on its efficacy in different clinical contexts.

3. The Heart Team

The choice of the best treatment strategy for a patient with severe AS who meets intervention criteria will depend on multiple factors, such as age, comorbidities, risk scores, presence of specific clinical conditions not considered in risk scores, and anatomical characteristics assessed using imaging studies, among others.

For these reasons, the concept of Heart Team (HT) emerges to assist the treating physician in decision-making across different clinical scenarios. The HT is a multidisciplinary and collaborative team where each member should be able to contribute their opinion freely, without generating internal conflicts.

The HT should include cardiologists, interventional cardiologists with experience in structural heart disease, cardiovascular surgeons, cardiovascular imaging specialists, geriatricians, anesthesiologists, and nurses. Additionally, depending on the patient’s clinical conditions, other specialists may be required to address the patient’s specific pathology.

The ability of the HT to predict early mortality is superior to that of the best available risk scores, supporting its effectiveness in referring patients to the most appropriate treatment4.

The goal of the HT is to optimize risk assessment and determine the best strategy, while also clearly communicating and addressing all questions from the patient and their family regarding risks, expectations, and future quality of life.

Hospitals seeking to establish a TAVI program must have a trained HT capable of accurately assessing and stratifying patient risk, offering the most appropriate (surgical or endovascular) strategy for each case. It would also be desirable for these teams to participate in registries or studies, engage in academic activities, and publish their results comprehensively. In this way, the HT enhances decision-making efficiency and reduces costs for healthcare systems.

Recommendations	Class	Level of evidence
Patients with severe aortic stenosis who meet intervention criteria should be assessed by a multidisciplinary Heart Team	I	C
Consulting with the Heart Team or referring to a center with one to define treatment options is the reasonable alternative in patients with severe valvular disease who present with: 1. asymptomatic severe valvular disease, and/or 2. multiple comorbidities.	IIa	C

4. Frailty assessment

In recent decades, population aging has seen an increase in the incidence and prevalence of various geriatric disorders such as gait disturbances and falls, sarcopenia, malnutrition, depression, and cognitive decline. Among these, frailty is a particularly notable condition. It is defined as a reduction in the ability to restore homeostasis in response to pathological and iatrogenic stressors, such as an interventional procedure5. There is significant variability in the use of this term due to the lack of consensus regarding its definition and assessment scales, as well as that it is often confused with functional decline and multimorbidity.

Frailty assessment should not rely on a subjective approach but rather on a combination of various objective measurements6-8. The scale developed by Linda Fried9, a pioneer researcher in this specific subject, defines frailty as a syndrome that includes reduced gait speed, decreased strength, weight loss, fatigue, and inactivity10, 11. Patients who meet three of these criteria are classified as frail. Other proposed scores for assessing these patients include the Rockwood Clinical Frailty Scale (CFS), the Short Physical Performance Battery (SPPB), Essential Frailty Toolset (EFT), and the Edmonton Frail Scale. Among these, the Edmonton Frail Scale stands out for its speed and ease of application, and multidimensional assessment12, 13.

Despite variations in definitions and assessment scales, frailty is highly prevalent in patients with severe AS and is associated with increased mortality, complications, disability, deterioration in quality of life, and hospitalization14.

Hospitals seeking to establish a TAVI program should include in their Heart Team geriatric specialists who are knowledgeable in managing patients with severe AS. These specialists should conduct a frailty assessment to stratify surgical risk and determine futility.

Recomendaciones	Clase	Nivel de evidencia
En pacientes adultos mayores en plan de TAVI se debe evaluar la fragilidad para estratificar riesgo quirúrgico y definir futilidad	I	C

5. Indications for TAVI

In patients with severe AS requiring valve replacement, SAVR and TAVI can be considered complementary treatments.

Numerous randomized studies have evaluated the efficacy and safety of both treatments across the entire risk spectrum of aortic stenosis.

Various clinical practice guidelines from different scientific societies recommend TAVI or SAVR as treatment alternatives, depending on each patient’s individual risk15-17. Table 1 summarizes the conditions that favor TAVI or SAVR in patients with severe AS.

For patients with prohibitive surgical risk (Society of Thoracic Surgeons [STS] Predicted Risk of Mortality Score >10%), TAVI has been shown to be superior to conventional medical treatment, significantly improving their survival and quality of life18. In high-risk patients (STS score >8%), TAVI has proven to be non-inferior to SAVR, providing similar results in terms of survival and short- to mid-term adverse events19, 20. For intermediate-risk patients (STS score between 4% and 8%), studies with 5-year follow-up data have shown that TAVI maintains efficacy and safety, confirming it as a viable alternative to traditional surgery21-26. Additionally, in low-risk patients (STS < 4%), TAVI has been compared with SAVR, demonstrating non-inferiority at two years, with promising long-term (up to 10 years) results in terms of survival and valve function26-30. These findings highlight the versatility and potential of TAVI as a treatment option across a wide range of risk profiles, emphasizing its crucial role in the modern management of severe aortic stenosis.

Recomendaciones	Clase	Nivel de evidencia
In patients with symptomatic severe aortic stenosis and extreme or prohibitive surgical risk (STS >10%), transfemoral TAVI is recommended.	I	A
EIn patients with symptomatic severe aortic stenosis and high surgical risk (STS >8% or high geriatric risk):: • If feasible, transfemoral TAVI is recommended. • If transfemoral access is not feasible, TAVI using alternative access routes is recommended.	I II	A A
In patients with symptomatic severe aortic stenosis and intermediate surgical risk (STS 4-8%):: • TAVI is a reasonable alternative to SAVR in patients over 80 years of age with favorable anatomy. Class I. Level of evidence A. • In patients aged 70-80 years with increased geriatric risk, TAVI is a reasonable alternative to SAVR if transfemoral access is feasible. Class I. Level of evidence A.. • Discussion within the Heart Team is recommended in the case of patients with intermediate surgical risk and high-risk anatomy for TAVI, such as adverse aortic root, low coronary ostium, and bicuspid valve.	I I II	A A C
In patients with symptomatic severe aortic stenosis with low surgical risk (STS < 4%) over 75 years of age, TAVI is a reasonable alternative to SAVR if transfemoral access is feasible.	I	A
In patients with symptomatic severe aortic stenosis with low surgical risk (STS < 4%) under 75 years of age, surgical aortic valve replacement is recommended.	I	A

6. Contraindications for TAVI

TAVI should be considered contraindicated in patients with a low life expectancy and/or futility criteria, as it will not provide clinical benefit to the patient and its social cost will be high15, 16, 31. This requires special consideration in an emerging country, where healthcare costs are very high and there is no national industry producing TAVI prostheses.

Futility is defined as a life expectancy of < 1 year or a lack of symptomatic or functional improvement after 6 months. Given the characteristics of the population, special emphasis should be placed on functionality, cognitive assessment for dementia, and the presence of oncological disease, which is often detected through CT angiography for TAVI32, 33. A recommendation is made that the Heart Team, with possible involvement from oncology specialists, determine futility in cases of malignant disease.

Recommendations	Class	Level of evidence
TAVI should be considered contraindicated in patients with a life expectancy < 1 year or who meet futility criteria.	I	C

7. The role of aortic valvuloplasty

Balloon aortic valvuloplasty (BAV) may be considered as a bridge treatment to definitive therapy with TAVI or SAVR in critically ill patients with severe AS (refractory acute pulmonary edema or cardiogenic shock)15, 16.

In symptomatic patients with severe AS for whom TAVI has been contraindicated due to futility, palliative treatment with BAV is effective for short-term symptom relief as well as safe, with low rates of associated complications34, 35.

BAV can be performed through a transradial approach to reduce vascular complications in elderly patients. Preliminary results, including findings from our region39, suggest equal benefit and excellent safety36-38.

In patients deemed unsuitable for TAVI due to severe frailty, bridge BAV could improve their frailty status, potentially transforming them into candidates for TAVI37.

BAV may be considered in patients with moderate to severe AS where symptom origin is undetermined and cannot serve as therapeutic proof.

BAV is recommended for patients with severe AS who need to undergo high-risk non-cardiovascular surgery (IIa C), even though recent retrospective studies do not support its efficacy37, 40.

Recommendations	Class	Level of evidence
Aortic valvuloplasty may be considered as a bridge treatment to TAVI or SAVR in patients with refractory acute pulmonary edema or cardiogenic shock.	IIb	C
Aortic valvuloplasty may be considered as a bridge treatment to TAVI or SAVR in patients scheduled for major non-cardiac surgery.	IIa	C
Aortic valvuloplasty may be considered as palliative treatment in patients with contraindications for TAVI or SAVR.	IIb	C
Aortic valvuloplasty through transradial access to reduce vascular complications.	IIa	C

8. The TAVI procedure

Regarding TAVI as a procedure, it is essential to emphasize that patient preparation should follow the same strict standards as a conventional surgical procedure.

This includes the evaluation for and prior treatment of potential infectious foci, such as dental or urinary tract infections, which are common in the elderly population and can compromise procedural success.

Additionally, it is crucial for the intervention to take place in a properly prepared surgical environment. If the procedure is conducted in the cath lab, the circulation of non-essential personnel should be minimized, and all involved personnel must strictly adhere to aseptic protocols, including the use of surgical caps and face masks.

It is important to note that failure to comply with these requirements can significantly increase the risk of infection and postoperative complications.

9. Role of CT angiography in

prosthesis sizing and vascular

access selection

9.1. Prosthesis sizing

The systematic use of endovenous contrast-gated CT angiography for the assessment of TAVI candidates allows for proper prosthesis selection and sizing41.

It should be noted that annulus measurement uses a specific point in the cardiac cycle (generally 30%-40%), since the reduction in ellipticity and annular edge stretching during systole results in a larger annular area and perimeter than during diastole (interdependence of the aortic and mitral valves)42.

Once the imaging exam is completed, it should be processed with a DICOM image management software (Osirix, Horos, Trimensio, etc.). The use the polygon tool that connects the points with curved lines is recommended for more accurate measurements, as freehand measurements may overestimate the area43.

For proper prosthesis sizing (and type selection), the following aspects should be taken into account:

9.1.1. Aortic annulus

The aortic annulus is defined as the circumference within a virtual plane formed by the union of the most basal points of the three aortic valve sinuses. Figure 1 explains the step-by-step process to analyze it.

Balloon-expandable valves are typically sized based mainly on the annular area, while self-expanding valves are sized based on the perimeter. The reasons for this are partly historical but also reflect differences in how ‘oversizing’ is calculated44. In this regard, oversizing is calculated as Oversizing [%] = ([Nominal prosthesis size / Patient annulus size] - 1) × 100 (Supplementary Table 1). It is very important to keep in mind that if the annulus is measured using the area, changes in the measurement will exponentially affect the area (since area = π * radius^2), while variations in the measurement of the perimeter will cause proportional variations (perimeter = π * diameter)45. Consequently, incorrect area measurement may lead to the use of larger-than-required balloons and valves, with a risk of annular rupture. As for rupture risk, female sex, use of balloon-expandable valves, history of radiotherapy, chronic glucocorticoid use, and moderate/severe sub-annular calcification (mainly beneath the commissure, between the non-coronary and left coronary leaflets) increase the risk46.

To determine implant projection, we must adjust the cusps for the three aortic sinuses to set the commonly used views: the ‘coplanar’ view, with the three cusps independently aligned (usually a left anterior oblique, cranial projection), or the ‘cuspoverlap’ view, where the right and left cusps are aligned, leaving the non-coronary cusp isolated (usually a right anterior oblique, caudal projection). The benefit of the latter is that it better displays the left ventricular outflow tract (LVOT), where the conduction system lays, allowing the device to be released as high as possible to avoid interaction with it. While patient anatomy is aligned in this way (in the CT S-curve), the prosthesis S-curve is yet to be aligned. For parallax correction, the angiography device should be angled cranially or caudally to align the device markings47.

9.1.2. Left ventricular outflow tract

The left ventricular outflow tract should be measured in the first 4 or 5 mm of the sub-annular space43. Typically, there is a proportional relationship between the LVOT and the annulus, making it useful in cases of borderline prosthesis selection. Another relevant aspect is that the presence of severe calcification with protrusion at the LVOT increases the risk of paravalvular leak48. Additionally, this is where the conduction system is found. If it is damaged during the implantation procedure, it can cause atrioventricular block and require permanent pacemaker implantation, especially when there is severe calcification or complete right bundle branch block49.

9.1.3. Valsalva sinuses

The diameter of the Valsalva sinus should be measured from cusp to commissure, parallel to the annular plane. This measurement is crucial for the valve implantation feasibility assessment, as the sinuses must be large enough to accommodate the various valves. Similarly to the LVOT, the Valsalva sinuses are key for prosthesis selection in borderline cases.

9.1.4. Coronary height

Coronary ostium height should be measured perpendicularly, from the valve plane to the lower edge of the coronary origin. When combined with a small Valsalva sinus diameter (< 30 mm), a low origin (< 12 mm) is associated with increased risk of coronary occlusion.

9.1.5. Sinotubular junction

Measuring the sinotubular junction (STJ) is key to anticipating any potential contact with the prosthesis. In relation to balloon-expandable valves, knowing the diameter and height is essential, as small STJs account for an increased risk of injury with this type of prosthesis. The STJ diameter should be measured in an oblique transversal plane, generally not parallel to the annular plane. STJ height should be measured from the annular plane to the lowest edge of the junction.

9.1.6. Aortic angulation

Aortic angulation is defined as the angle between the annular plane and a horizontal plane in the coronal projection. Excessive angulation can complicate valve crossing, hinder optimal positioning, and make coaxial prosthesis alignment difficult, reducing control over the device and favoring prosthesis displacement. A horizontal aorta, i.e. an angle >48°, is associated with a lower success rate, especially with self-expanding valves50.

9.1.7. Sizing in bicuspid aortic valve

The Sievers and Schmidtke classification allows for the identification of three types of bicuspid valve: type 0 (no raphe, two leaflets), type 1 (one raphe with fusion of the left coronary cusp with the right coronary cusp or the non-coronary cusp), and type 2 (two raphes, fusion of the left coronary cusp with both the right coronary and non-coronary cusps)51. In 2016, a new classification proposed by Jilaihawi et al. outlined three possible morphologies: acquired or functional bicuspid (fused tricommissural) valve, raphe-type bicuspid valve, and non-raphe bicuspid valve52.

While in tricuspid valves the anchoring site is at the annulus, in bicuspid anatomies it is often above the annulus, so both measurements should be taken at the annular and supra-annular planes (which is referred to as the intercommissural distance, 4 mm above the annular plane, from one commissural center to another). There is currently no clear consensus on the best sizing method for this type of valve disease, so it is important to consider the measurements from both the annular and supra-annular planes, as well as the calcium load and its localization, and raphe characteristics to determine the proper prosthesis type and size. Since the annular area is often severely elliptical, prosthesis oversizing is usually greater, leading to a higher risk of annular rupture, especially in type 1 bicuspid valves53.

The tomographic analysis of the BAVARD registry compared annular measurements and intercommissural distance (ICD) in type 0 and 1 bicuspid valves, yielding three different configurations: “tubular” (equal annular and supra-annular diameters), “flare” (annular diameter smaller than supra-annular diameter), and “taper” (annular diameter larger than supra-annular diameter)54. The traditional annular sizing method was applied in most cases (80-90%) and, in “taper” morphologies, supra-annular plane measurement was found to be useful, with favorable results.

The LIRA method (Level of Implantation at the RAphe) suggests that prosthesis anchoring should occur at the level of the most rigid anatomical structures (calcification/fibrosis) at the raphe55. Therefore, the perimeter should be analyzed at both the basal annulus level and at the site of maximum raphe protrusion. In case of discrepancy, the prosthesis should be selected based on the smaller perimeter.

The CASPER algorithm is based on three main factors: raphe length, calcium burden, and calcium distribution (all related to incomplete valve expansion). Starting from the annulus-derived diameter, several millimeters (up to 2.5 mm) are subtracted taking into account the presence of heavy calcium burden, raphe length and calcium distribution56.

Finally, there is the “circle method” for cases using balloon-expandable valves. It involves projecting circles that mirror prosthesis diameter every 3 mm above the annular plane to understand how it might interact with the valvular structure. We can consider three possible scenarios: if the circles are larger than the valvular anatomy, there is a risk of annular rupture; if the circles touch the valvular anatomy, proper sealing can be expected; if the circles are smaller than the annulus, there is an increased risk of paravalvular leak57.

9.1.8. Sizing in aortic regurgitation

The main anatomical challenges for TAVI in cases of aortic regurgitation are the lack of annular and leaflet calcification (which is necessary for device anchoring and stabilization during implantation), increased stroke volume (which complicates stable release), and the presence of aortic root dilation (which complicates proper device positioning and release), leading to a higher risk of embolization or prosthesis malapposition into the aorta (‘pop-up’) or the left ventricle58. Greater prosthesis oversizing (15-20%) has been proposed to reduce the risk of embolization. Another suggested alternative is the use of valves specifically designed for this condition.

9.2. Vascular access selection:

Given the evolution of delivery systems (becoming more hydrophilic and with improved navigability) combined with their reduced size, 95% of all cases can use a transfemoral approach59. The use of alternative approaches (subclavian, carotid, caval, or transapical) is associated with a higher incidence of vascular complications compared to the transfemoral approach60. Computed tomography is the best imaging strategy to determine the feasibility of each approach, as well as to avoid vascular complications61.

Access selection should consider the following variables:

9.2.1. Iliofemoral axis diameters:

The maximum and minimum diameters of both iliofemoral axes are measured by CT angiography. While they can be measured manually using three-dimensional reconstruction, there is software to do so automatically (Figure 2). Knowing the outer diameter of the delivery system for the selected prosthesis is crucial. However, a ≥5.5-cm diameter is generally good enough to advance the most commonly used prostheses (Supplementary Table 2)62.

9.2.2. Iliofemoral axis calcification:

We must assess the extent and distribution of calcification across the iliofemoral axis, especially of circumferential or semi-circumferential calcification in tortuous or bifurcated areas, as it may hinder delivery system or prosthesis advancement. In cases of severe calcification, there is a recommendation to add 1 mm to the minimum diameter to ensure the device can progress.

9.2.3. Iliofemoral axis tortuosity:

This is defined as the presence of vessels with multiple curves and countercurves. Its assessment is facilitated by using “volume-rendering” software. While they do not constitute formal contraindications to transfemoral access, severe angulation and number of curves are independent predictors of vascular complications, especially in cases of severe calcification63.

9.2.4. Arterial puncture:

The key is a correct assessment of the anterior wall to rule out severe calcification or proximal stenosis that may interfere with the endovascular closure device64. Additionally, the use of ultrasound allows for a precise selection of the femoral artery puncture site; a puncture too high increases the risk of retroperitoneal bleeding, while a puncture too low (in the superficial femoral artery) increases the risk of pseudoaneurysm65. Ultrasound-guided puncture is recommended, as it facilitates a swift assessment of both aforementioned key points66.

10. Types of TAVI prostheses

Balloon-expandable and self-expanding valves have emerged as a safe and effective option for the treatment of severe AS. Unlike self-expanding valves, balloon-expandable prostheses must be mounted on a balloon, which is inflated in the desired position. This implantation mechanism allows for greater precision as regards the selected prosthesis position.

Balloon-expandable and self-expanding valves initially evolved in similar ways. However, balloon-expandable prostheses are associated with lower rates of need for pacemaker implantation and a lower prevalence of greater-than-moderate paravalvular leak. On the other hand, they have accounted for higher rates of stroke and worse hemodynamic profiles67, 68. Another advantage of this type of valve includes coronary access and positioning in angled aortas. Regarding coronary access, due to their height and the open cells in their upper segment, they significantly facilitate coronary cannulation. As mentioned, balloon-expandable valves are usually easier to position in angled aortas, which makes them the preferred option in cases where patient anatomy is technically challenging. Their design allows for greater control during implantation, which is especially beneficial in situations where precision is crucial.

In some specific scenarios, such as small aortic annuli (area < 430 mm²) and valve-in-valve procedures, both valve types have shown similar clinical outcomes. As for their hemodynamic profile, self-expanding valves performed better, as they had a larger effective orifice area, lower transvalvular gradient, and less prosthetic dysfunction69, 70.

10.1. Self-expanding valves

• Evolut R® and Evolut Pro® and Evolut Pro+® (Medtronic, United States):

The Evolut R valve is a second-generation device, and the Evolut Pro/Pro+ valve is a third-generation device. The primary difference between them is an external wrap in the first cells of porcine pericardium, aimed at reducing the incidence of paravalvular leak, and the presence of markers to optimize commissural alignment (in the Evolut Pro+ device). Both generations are repositionable, with a supra-annular design. The device is composed of a self-expanding nitinol stent and porcine pericardial leaflets. It is available with a 23-, 26-, 29-, or 34-mm diameter, for 18-to-30-mm diameter aortic valve annuli.

It includes a 14-French (Fr) release system and is compatible with 0.035’’ guidewires. The Evolut Pro+ version has a reduced delivery profile, designed for patients with small access vessels of up to 5.0 mm.

• Acurate Neo 2® (Boston Scientific, United States)

The Acurate Neo 2 valve is a self-expanding nitinol device with a biological porcine valve and supra-annular design. It is a repositionable device. It is available in three different sizes, S, M, and L, for 21-to-27-mm diameter aortic annuli. Unlike its predecessor, the Acurate valve, this generation features an external skirt of porcine pericardium, Active PV Seal®, which creates an active periprosthetic seal to prevent paravalvular leak.

Unlike other self-expanding devices, this valve has a unique top-down release system and 3 stabilizing arches.

Its release system is compatible with an expandable 14-Fr introducer and 0.035’’ guidewires, making it suitable for patients with up to 5.5-mm diameter vessels.

• Navitor Valve System® (Abbott, United States)

The Navitor device is a bovine pericardial valve mounted on a self-expanding nitinol stent. It is a repositionable and recapturable device, with an intra-annular design. It has an external skirt made of bovine pericardium with NavSeal® technology to reduce paravalvular leak.

It is available in 23-to-29-mm diameters for native 19-to-27-mm diameter aortic annuli.

The NavFlex® release system is compatible with a 14-French introducer for up to 5-mm diameter vascular accesses.

• Venus A-Valve® and Power X® (Venus MedTech, China):

The Venus A device is a self-expanding, repositionable, and recapturable valve made from porcine pericardium with a supra-annular design. It is available in 23, 27, 29, and 32 mm. It has a 16-and-18-French release system and a 20-French release system for the 32-mm valve.

• Hydra Valve® (SMT, India)

The Hydra Valve device is a repositionable and recapturable valve with a supra-annular design, mounted on a self-expanding nitinol stent, with 3 extensions for release stabilization and a sealing skirt to reduce paravalvular leak. It is made from bovine pericardium. It is available with a 22-, 26-, or 30-mm diameter, for native 17-to-27-mm diameter aortic valve annuli. It has a 14-Fr release system.

• VitaFlow® (Microport, China)

The VitaFlow valve is a repositionable and recapturable device with supra-annular design made from bovine pericardium, mounted on a self-expanding nitinol stent with a PET sealing skirt. It is available with a 21-, 24-, 27-, or 30-mm diameter, for native 17-to-29-mm diameter aortic valve annuli. The release system is 16- and 17-French for 21- and 24-mm or 27- and 30-mm devices, respectively. It is motorized or manually released.

10.2. Balloon-expandable valves

• Edwards SAPIEN® (Edwards Lifesciences, United States).

This is balloon-expandable valve mounted on a cobalt-chromium structure with bovine pericardial leaflets. The SAPIEN 3 version has an external skirt to prevent paravalvular leak and thinner struts than its predecessor.

It can be used in annuli ranging from 18 to 29 mm, with valve sizes of 20, 23, 26, and 29 mm. Its release system is deflectable and compatible with 14-Fr introducers for 20-to-26-mm valves and 16-Fr introducers for the 29-mm valve. It is compatible with 0.035” guidewires.

The system comes with its own 14-Fr expandable introducer (E-Sheath).

• Myval THV® (Meril Life Sciences, India)

This is a bovine pericardial valve mounted on a cobalt alloy structure with a height between 17 and 21 mm. Its lower half has closed cells to increase radial strength, while the upper half has open cells to avoid coronary ostia entrapment and facilitate access. It includes an internal PET cuff and an external skirt to minimize paravalvular leak and occlude microchannels.

It can be used in 18.5-mm to 32.7-mm annuli. This particular prosthesis adds to its traditional sizes (20, 23, 26, 29, and 32 mm) intermediate sizes (21.5, 24.5, 27.5, and 30.5 mm). This wide range of valve sizes allows for greater precision in selecting the ideal prosthesis. Its deflectable delivery system allows for excellent navigation through tortuous accesses and horizontal aortas.

The system comes with its own 14-Fr introducer (Python). It is compatible with all valve sizes and can be dilated up to 18 Fr with its own dilator, which allows for its use in accesses from 5.5 mm on. It is compatible with 0.035” guidewires.

11. Vascular accesses

11.1. Transfemoral access

The transfemoral access is the most used alternative, chosen in over 90% of all patients. It leads to a significant reduction in major vascular adverse events, which have been recently estimated to be less than 10%63, 71, along with rapid recovery and shorter hospital stays63.

Lumen diameter is the most commonly used variable to assess the minimum vascular dimension established by the manufacturer for safely crossing the iliofemoral axis. The minimum diameter considered for 14-Fr prostheses is 5.5 mm, and for 18-Fr delivery systems is 6.5 mm, although expert operators may use accesses with smaller diameters if the artery does not show calcification in 360° of its wall71. It is important to consider other variables to ensure success in transfemoral access, such as the presence and extent of calcification, as well as the degree and extent of vessel tortuosity and its angles. Additionally, it is important to assess the entire aorta, considering the transfemoral access as a whole, from the common femoral artery to the aortic annulus.

In cases of iliofemoral obstruction, there is evidence in the literature that ad hoc percutaneous angioplasty at this level can be combined to achieve adequate lumen and optimal sheath advancement, which may be combined with a lithotripsy system for severely calcified lesions. This is a safe and effective option for ensuring an appropriate approach71–74.

The common femoral artery can be approached using two techniques:

• The percutaneous approach is the first choice. Ultrasound-guided access is recommended, as it leads to a precise access site, reduces the number of vascular complications, and increases the success of vascular closure devices75.

• The surgical dissection technique allows for access to the femoral chamber and punctures the anterior wall of the common femoral artery. This is used, as mentioned earlier, in obese patients with deep femoral arteries (i.e., >8 cm from the skin) and vessels with 360-degree calcification, as percutaneous closure devices may fail in these cases. While it is a safe technique, it may have complications such as infections and seromas, which can prolong hospital stays and the time to ambulation.

Vascular closure devices:

The use of vascular closure devices (VCDs) has grown exponentially, decreasing procedure time, facilitating early ambulation, and enabling earlier discharge. Among the available closure devices (Table 2), there are those mediated by endovascular sutures (Perclose-ProGlide®, Abbott, United States), as well as hemostasis devices based on bioresorbable polymer components, such as the AngioSeal® (Terumo Interventional Systems, Japan) and the Manta® (Teleflex Essential Medical, United States) devices.

The most frequently used VCD in Argentina is the Perclose-ProGlide, which uses the “pre-close” technique, where two devices are inserted at the medial (2 o’clock) and lateral (11 o’clock) points before the procedure. After completing the procedure, the introducer sheath is removed, and the sutures are closed. This technique requires some experience, and its failure rate is around 5.4% to 8% of procedures. VCD failure is associated with increased morbidity and mortality rates and prolonged hospitalization76, 77.

The combined use of vascular closure devices, such as Perclose-ProGlide® and AngioSeal®, has proven to be an effective strategy for achieving complete hemostasis in TAVI procedures via transfemoral access78. In particular, the MultiCLOSE algorithm, which uses a pre-close technique followed by reinsertion of a smaller introducer, has shown excellent results. In a recent study, this technique achieved complete hemostasis in 98% of the 630 treated patients, with a low rate of overall vascular complications of 2.8%, and a rate of major complications of less than 1%78.

The Manta vascular closure device is a new-generation VCD specifically developed for closing large-caliber arteriotomies with a single device. It is based on a proven intra-arterial anchoring and extra-arterial collagen plug combination. It is available in two sizes: 14 and 18 Fr. It can be used for sheath sizes ranging from 10 to 14 Fr and from 15 to 22 Fr, respectively.

It is essential to always perform angiographic confirmation or ultrasound verification after closure, regardless of the system used, to detect hidden VCD failures, vascular occlusions, or subcutaneous deployments, thus accelerating corrective measures.

11.2. Subclavian/axillary access

The axillary/subclavian access should be considered as the alternative of choice when the transfemoral access site is limited by severe iliac or femoral lesions, small femoral or iliac diameters, previous iliac or femoral surgery, excessive calcification or tortuosity, or previous aortic aneurysm/aortic abdominal prosthesis79.

Currently, subclavian/axillary access accounts for 34% of all alternative accesses in TAVI80, with a mortality rate lower than the transapical access, but with a numerically higher risk of stroke compared to the transfemoral access (6.5% vs. 3.5%, p = 0.165)80. This alternative typically offers smaller diameters compared to the transfemoral access81.

Operators should preferably use the left subclavian or axillary artery, and while the recommendation is to use a surgical approach, recent reports mention percutaneous closure82.

Contraindications for subclavian/transaxillary access include inadequate vessel diameter, prior vascular procedures or surgical repairs, stenosis, tortuosity, previous aneurysmal dilation or dissection, and morbid obesity. Its use should be avoided in patients with a patent internal thoracic artery graft, unless it is the only access option and the vessel is >8 mm83.

11.3. Carotid access

One of the key aspects to consider when contemplating carotid access is the need to assess for carotid atherosclerosis and patency of the circle of Willis, as it could limit cerebral perfusion during carotid occlusion. The right carotid artery is typically used, and patients with >80% stenosis in the common carotid artery or with internal carotid stenosis are usually excluded.

It is important to note that carotid access can only be achieved using a surgical approach (as opposed to percutaneously), which adds an additional layer of complexity to the procedure.

When compared to transfemoral access, carotid access was associated with a higher risk of stroke, with no increase in the risk for 30-day mortality, bleeding, or vascular complications84. In a French carotid TAVI registry, which included patients who were not eligible for transfemoral TAVI due to peripheral arterial disease in most cases, carotid access in TAVI was associated with a 1.6-% rate of stroke/TIA, a 4.1-% rate for major bleeding, and a 3.2-% rate for 30-day mortality85.

In conclusion, while carotid access has been associated with a higher stroke rate, it is a possible alternative for patients with contraindications to transfemoral access and should only be performed in experienced centers.

11.4. Transcaval access

Transcaval access, i.e. through the inferior vena cava, consists of achieving transfemoral venous access, navigating to the inferior vena cava, and puncturing from the inferior cava to the descending aorta, to then advance the selected TAVI device. Once completed, the hole is closed with a nitinol closure device. Potential complications include aortic dissection, retroperitoneal hematoma, or fistula86.

A multicenter registry assessed the feasibility of transcaval access with a procedure success rate of 99%, a 30-day mortality rate of 8%, and a vascular complications rate of 11%87. In this registry, researchers observed that over 90% of the aorto-caval fistulas created for access had closed86.

When compared to other alternatives, transcaval access proved to be competitive, with no significant differences in 30-day mortality during follow-up88.

In conclusion, transcaval access could be an alternative for patients with contraindications for transfemoral access and other arterial accesses, and should only be performed in experienced centers.

Recommendations	Class	Level of evidence
Ultrasound-guided percutaneous transfemoral access should be the access of choice in TAVI.	I	A
Axillary/subclavian access should be considered as the alternative access of choice in patients with contraindications for transfemoral access and in experienced centers.	IIa	C
Carotid access may be considered as an alternative access in patients with contraindications for transfemoral access and in experienced centers.	IIb	C

12. Complications of TAVI

12.1. Paravalvular regurgitation

Post-TAVI paravalvular leak (PVL) has a higher prevalence than PVL in patients who underwent SAVR89, 90. The development of new-generation repositionable prostheses, with designs that include mechanisms for better adaptation and opposition to valvular annulus anatomy and adjacent structures, has helped reduce the incidence of PVL compared to earlier devices.

There is clear evidence about the impact that moderate to severe PVL has on the rates of rehospitalization and all-cause and cardiovascular mortality in the short and long term91, 92.

However, information about the consequences of mild PVL is contradictory; a recently published meta-analysis suggests that the presence of mild leak also increases the incidence of mortality and rehospitalization93.

The most recognized predictors of PVL are the calcification of the aortic root (annulus, leaflets, commissures, and left ventricular outflow tract, especially when its distribution is asymmetric), insufficient prosthesis oversizing, elliptical annuli, bicuspid valve disease, excessively low implants, and marked angulation between the outflow tract and the aorta (the last two are applicable in the case of self-expanding prostheses)94.

Regarding diagnosis, angiography performed immediately after implantation, in the case of balloon-expandable valves, or after 10 minutes, with self-expanding valves, allows for an assessment of the leak, most commonly using the Sellers classification.

The aortic regurgitation index (ARI), calculated as the difference between diastolic aortic pressure (DAP) and left ventricular end-diastolic pressure (LVEDP) divided by systolic aortic pressure (SAP) [ARI = (DAP – LVEDP) / SAP × 100)], provides an immediate physiological assessment and prognostic information. Patients with ARI < 25 experienced a significant increase in the one-year mortality rate compared to those with ARI≥ 25 (46% 16.7%; p < 0.001)95-96

Doppler echocardiography is the tool most commonly used to determine the degree of regurgitation immediately after the procedure and especially during follow-up. However, the assessment of post-TAVI leak is peculiar due to, among other factors, the different prosthesis components, the existence of multiple jets, and the various directions and morphologies that both prosthesis and calcium impose on these jets in the left ventricular outflow tract, all of which make interpretation a more complex task. A complete evaluation should include qualitative, semi-quantitative, and quantitative parameters. Their detailed description was recently updated in an intersocietal consensus that includes an algorithm to guide the implementation of the multiple available parameters97.

Balloon post-dilation may help improve expansion and reduce leaks, especially in cases of under-expansion due to severe calcification. Balloon size should not exceed the average native valve diameter. For self-expanding prostheses, the recommendation is for a straight balloon with a diameter one millimeter smaller than the valve placed. If post-dilation is performed using the proper technique and under rapid pacing, the described complications (prosthesis migration, annular rupture, coronary obstruction, and cerebral embolism) are uncommon98.

Finally, percutaneous PVL closure using vascular “plugs” may be useful when the regurgitation jet is localized. The most commonly used devices are the Amplatzer Vascular Plug (Abbott, USA) III and IV, with which, in a recently published registry, regurgitation was reduced to less than mild in 91% of cases99.

12.2. Conduction disturbances

Electrical conduction abnormalities are a relatively frequent complication during TAVI due to the anatomical proximity between the aortic valvular complex and the cardiac conduction system. The anatomical relationship between the bundle of His and the membranous interventricular septum, and the emerging path of its left branch along the base of the triangle that separates the non-coronary and right coronary cusps, exposes the conduction system to damage caused by direct compression, with varying degrees of edema, hematoma, and ischemic injury100. On the other hand, regardless of its mechanical effect, the extension of aortic calcification to the conduction system causes complete left bundle branch block (LBBB) and advanced conduction disturbances100, 101. Correct analysis of the electrocardiogram obtained before TAVI is essential to define the risk for conduction disorders and the need for permanent pacemaker implantation (PPI).

The presence of complete right bundle branch block (RBBB) is the most important risk factor: it increases the risk up to 47 times and is associated with increased mortality100, 102.

Other predictors of PPI include the presence of first-degree atrioventricular block (AVB) and left anterior hemiblock, complete AVB during the procedure, and balloon valvuloplasty prior to implantation.

Membranous septum (MS) length is also an independent predictor of the need for PPI. The INTERSECT registry defined three risk groups according to the relation between MS length and need for PPI: >20% in MS ≤3 mm, 10-20% in MS 3-7 mm, and < 10% in MS >7 mm103.

First-degree AVB does not appear to be an independent predictor of need for PPI, but PR interval prolongation during or after the procedure does104.

Regarding implant-related factors, the “cuspoverlap” technique allows for elongation of the interventricular septum, enabling higher positioning and significantly reducing the need for PPI105, 106. Recently, a research group in Argentina published the predictors of permanent pacemaker implantation in self-expanding valves in the era of “cuspoverlap.” The results showed that implant depth, first- or second-degree AVB, RBBB, and incomplete left bundle branch block were independent predictors of need for PPI. While patients who required PPI did not experience a significant increase in the risk of death, myocardial infarction, stroke, hemorrhagic events, or vascular complications at 30 days, they did have prolonged hospital stays107.

The presence of LBBB during or immediately after TAVI is relatively frequent, and while its impact on the need for PPI remains controversial, it is widely recognized as a cause of higher long-term mortality108, 109.

Finally, performing an electrophysiological study can help identify the need for permanent pacemaker in controversial cases, where it has a high negative predictive value110.

12.3. Vascular access

Vascular access complications are a significant cause of morbidity and mortality, both in-hospital and within 30 days111. Additionally, they are associated with prolonged hospital stays, higher in-hospital costs, and reduced quality of life. A reduction in TAVI devices and increased operator experience have resulted in a decrease in these complications to less than 4%112, 113.

Predictors of vascular access complications include female sex, small-caliber access or with circumferential calcification, marked iliac tortuosity, and use of >19-Fr introducers. Regardless of device size, a sheath-to-femoral artery ratio (SFAR) >1.05 is also an independent predictor of major vascular access complications and 30-day mortality114.

The most common vascular access complications include iliac artery dissection, arterial rupture, puncture-site hematoma, pseudoaneurysm, and retroperitoneal hematoma. Prevention is crucial, and when these complications occur, early diagnosis and prompt treatment are of the utmost importance.

Management can be either surgical or percutaneous. For percutaneous treatment, contralateral access may be used, with prolonged balloon inflations to reduce bleeding and achieve hemostasis, stents for dissection management, or coated stents in the case of rupture or perforation. Having coated stents readily available is essential for the management of bleeding emergencies during TAVI procedures. These devices enable rapid and effective bleeding control, thus preventing the need for major surgical interventions. Therefore, their inclusion as mandatory equipment ensures patient safety and timely response in critical cases.

For the treatment of pseudoaneurysms, ultrasound-guided manual compression may be effective depending on size. The alternative is a selective thrombin injection for those with a neck diameter >3 cm.

In cases of retroperitoneal hematoma not responding to initial medical treatment, considerations may include embolization of damaged small vessels, if applicable; use of coated stents, for larger vessels, and surgical exploration114.

A reduction in introducer profile, vascular access assessment through imaging techniques, appropriate access site selection, and growing operator experience all result in a decreased incidence of these complications.

12.4. Stroke

Stroke remains one of the most feared complications for patients undergoing TAVI. It leads to a 30-day morbidity and mortality rate up to six times higher compared to patients without stroke115. Over the years, improvements in experience, techniques, devices, and patient selection have contributed to better outcomes.

Stroke has a substantial impact on patients, their families, healthcare services, and society as a whole. It affects morbidity, mortality, and socioeconomic burden, depending on the residual quality of life of patients. Contemporary TAVI-related stroke rates remain between 2% and 4%26, 115.

Additionally, the potential impact of silent brain lesions—affecting up to 20% of patients—on cognitive function and their prognostic relevance over the medium and long term are still unclear116.

Table 3 summarizes predictors and factors of early (immediate or peri-procedural) stroke. Some of these factors are also associated with the incidence of stroke later on (beyond the peri-procedural period), including:

• Age

• Native valve and/or aortic fracture (calcified; bicuspid)

• Hostile aortic arches

• Valve-in-Valve/TAVI-in-TAVI procedures

• Incomplete valve stent endothelialization

• Device thrombosis

• Suboptimal antiplatelet effect

• New-onset atrial fibrillation

• General prothrombotic condition of the patient

Prevention and management of stroke during TAVI

Prevention of a potential stroke during the procedure includes the strategies detailed below.

Proven strategies:

• Adequate anticoagulation

• Operator and site experience

• Refined implantation technique

• Improved device technology (deflectable, repositionable, coated, hemodynamically optimized device)

Strategies under active investigation:

• Use of cerebral embolic protection devices

• Optimal antithrombotic therapy after TAVI

• Left atrial appendage occlusion

Cerebral embolic protection devices (CEPDs) were developed to reduce the incidence of TAVI-related stroke caused by embolic debris reaching the brain. They have been proven safe in clinical trials117.

Currently available CEPDs are summarized in Supplementary Table 3. The SENTINEL® Cerebral Protection System (Boston Scientific, USA) is the most widely recognized CEPD and the only one available in our region. It consists of two polyurethane filters with 140-µm pores fixed to a flexible nitinol radiopaque frame. The filters are advanced from a 6-Fr sheath through the right radial or brachial artery and deployed at the ostia of the brachiocephalic trunk and left carotid artery. The device is designed to capture emboli in two of the three branches of the aortic arch, leaving the left subclavian artery unprotected along with the vertebral circulation.

The DEFLECT III, CLEAN-TAVI, and SENTINEL trials have all assessed the safety and efficacy of CEPDs117-119. These studies suggest that, while CEPDs are non-inferior for TAVI patients, they appear particularly beneficial for well-selected high-risk patients, such as those with prior stroke or high embolic risk. However, their use in TAVI remains uncommon in our region, with only marginal benefits due to the lack of well-designed cost-effectiveness studies at a local level.

12.5. Coronary obstruction

One of the greatest challenges in TAVI, one that entails immediate and potentially life-threatening risks, is the prevention of coronary obstruction (CO). The incidence of CO during TAVI varies across studies but is generally estimated between 0.5% and 3%120. While relatively rare, its consequences can be devastating, including acute myocardial infarction, malignant ventricular arrhythmias, and death121.

Risk factors that may increase the risk of coronary obstruction during TAVI include the following122:

• Coronary anatomy. Low coronary ostium, small Valsalva sinuses, tortuous/anomalous coronary arteries, and severe aortic valve calcification.

• Prosthesis type. Some prostheses may pose a higher risk of coronary obstruction due to their design or size, or in procedures such as Valve-in-Valve (VIV) or TAVI-in-TAVI.

• Center experience. Primary operator and multidisciplinary team expertise, particularly in relation to specialized implantation techniques such as cuspoverlap, commissural alignment, or left main coronary artery (LMCA) stenting.

• Patient comorbidities. Comorbidities such as concomitant coronary artery disease, previous revascularization, renal failure, and diabetes may increase the risk.

Prevention and management of CO during TAVI (Figure 3).

Preventing CO during TAVI requires a multi-imaging approach and meticulous procedural planning123. Below, some of the key steps.

• Comprehensive preoperative assessment: A detailed preoperative assessment with coronary angiography, high-resolution computed tomography, and echocardiography is essential to identify anatomical risk factors and plan the procedure accordingly.

• • CT assessment of coronary height, sinus size, and valve-to-coronary (VTC) distance: VTC distance refers to the gap between the edge of the newly implanted valve and the origin of the coronary arteries, and it is essential in relation to TAVI. A short distance (< 4 mm) increases the risk of coronary obstruction, particularly in patients with small Valsalva sinuses or heavily calcified valves, as valve expansion may displace tissue and block coronary flow124, 125.

• Proper prosthesis selection: The choice of valve prosthesis should be based on patient-specific anatomy. If appropriate, it should consider the potential risk for CO by including a virtual implant assessment to estimate its proximity to the coronary ostia.

• Meticulous implantation technique: Valve implantation technique must be precise, calculating implant height and accounting for potential commissural alignment, device dimensions, and surrounding structures.

• Continuous hemodynamic monitoring: Continuous real-time hemodynamic monitoring during the procedure helps detect early signs of myocardial ischemia and allows for immediate intervention.

• Balloon sizing: In some cases, this maneuver can help anticipate potential obstruction and assist in final prosthesis selection, if needed.

If CO occurs during TAVI, rapid intervention is crucial. Treatment options include the alternatives listed below.

• Valve repositioning: In some cases, temporary obstruction can be resolved by carefully repositioning the prosthetic valve.

• Coronary angioplasty with stenting (“Chimney” technique): A stent can be placed in the obstructed coronary artery to restore flow.

• Advanced laceration/perforation techniques (BASILICA126 procedure): In some cases, a small surgical procedure using radiofrequency-controlled electrocautery may be necessary to “cut and release” one of the leaflets. Whether dealing with a previous prosthetic valve or a severely thickened native leaflet, this advanced technique aims to restore and ensure coronary blood flow during TAVI.

13. Care after implantation

13.1. Antithrombotic therapy

Patients undergoing TAVI are generally elderly, a subgroup that typically presents a higher risk for both thrombotic and bleeding complications127. This requires careful individual assessment when determining the optimal antithrombotic treatment (Figure 4 and Table 4).

13.1.1. Thrombotic complications

Stroke:

Stroke occurs in 1%–8% of patients within the first year after valve implantation128. This complication is primarily caused by thromboembolism originating from the prosthetic valve or secondary to atrial fibrillation (AF).

AF is common in patients undergoing TAVI, with a pre-implantation prevalence of approximately 30% (ranging from 16% to 40%)129. A history of AF is a predictor of adverse events, leading to higher long-term mortality.

Additionally, new-onset AF is frequently observed after valve implantation. While its reported incidence varies across studies, a meta-analysis of over 240,000 patients found a new-onset AF incidence of 9.9% (ranging from 8.1% to 12%). This condition is associated with worse outcomes, including a higher risk of stroke (risk ratio [RR]: 2.35; 2.12–2.61) and death (RR: 1.76; 1.12–2.76) at 30 days, among other complications130.

Valve thrombosis:

Valve thrombosis has been reported in up to 25% of TAVI patients receiving antiplatelet therapy, though only a small percentage of the cases (1%–3%) are symptomatic due to increased transvalvular gradient. The association between subclinical valve thrombosis and stroke remains unclear, though some reports suggest an increased incidence131.

13.1.2. Hemorrhagic complications

Life-threatening or disabling major hemorrhage occurs in 3%–11% of patients within the first year after TAVI128. While 50% of these cases are directly related to the procedure, there are factors that contribute to an increased risk of bleeding during follow-up: advanced age, comorbidities, frequent presence of acquired von Willebrand factor deficiency, and moderate thrombocytopenia after TAVI, among others.

13.1.3. Antithrombotic management in patients without indication for anticoagulation

While dual antiplatelet therapy (DAPT) was initially recommended after TAVI, various observational studies and small initial randomized trials reported similar thrombotic events with the use of low-dose aspirin (ASA) alone, with a significant reduction in hemorrhagic complications132. Finally, the POPULAR-TAVI randomized trial (Cohort A) confirmed a significant reduction in all types of bleeding (15.1% vs. 26.6%; RR 0.57 [0.42-0.77], p = 0.001), major, life-threatening or disabling bleeding (5.1% vs. 10.8%; RR 0.48 [0.27-0.83]), and a composite endpoint of thrombotic and bleeding events (23% vs. 31.1%; RR 0.74 [0.57–0.95], p=0.04) at one year of follow-up with low-dose ASA compared to DAPT for three months after TAVI133.

On the other hand, the apparent better safety profile of direct oral anticoagulants (DOACs) associated with the risk of subclinical valve thrombosis, as previously described, led to studies evaluating their performance after TAVI. The GALILEO trial compared the outcomes of treatment based on low-dose Rivaroxaban (10 mg/day) versus DAPT, which was prematurely stopped due to excessive all-cause mortality (69%), death or thromboembolic events (35%), and major, life-threatening or disabling bleeding (50%) in the Rivaroxaban arm134.

Meanwhile, the ATLANTIS study assessed Apixaban against standard treatment in patients with and without an indication for anticoagulation. In the group without an indication for anticoagulation, primarily compared with DAPT (78.8%), there were no differences in the primary composite endpoints of efficacy and safety. However, there was less valve thrombosis at the expense of higher non-cardiovascular mortality with anticoagulant treatment135.

Finally, a recent network meta-analysis of randomized clinical trials demonstrated a greater than 50% reduction in hemorrhagic events with single antiplatelet therapy compared to treatment based on dual antiplatelet therapy or DOACs, with no differences in stroke, myocardial infarction, or systemic embolism136.

For this reason, in patients without an indication for oral anticoagulation or recent coronary angioplasty (less than 3 months), the current recommendation is monotherapy with low-dose aspirin15, 128.

13.1.4. Antithrombotic management in patients with indication for anticoagulation

Atrial fibrillation:

While the superiority of DOACs (direct oral anticoagulants) over vitamin K antagonists (VKA) in patients with non-valvular atrial fibrillation (AF) is well-established, initial studies raised doubts about their application after TAVI137. So far, there are few randomized clinical trials to address this question.

On one hand, the ENVISAGE-TAVI AF trial compared edoxaban to VKA, demonstrating non-inferiority in a composite of events that included all-cause death, thrombotic, and hemorrhagic complications. However, when specifically evaluating its safety, there was a higher incidence of major bleeding with edoxaban (hazard ratio [HR] 1.40 [1.03 - 1.91], p=0.93 for non-inferiority), primarily due to gastrointestinal bleeding138.

In contrast, in patients with an indication for anticoagulation in the previously mentioned ATLANTIS study, there were no differences between apixaban and VKA when evaluating both efficacy and safety endpoints135.

This limited and inconsistent evidence forces us to refer to the findings of large real-world registries. In an analysis of AF patients who underwent TAVI included in the STS/ACC TVT Registry, the risk of stroke at one year was similar between VKA and DOACs, while DOAC use was associated with reduced risks of bleeding, intracranial hemorrhage, and all-cause mortality139. Similar results were seen at 3 years in a large cohort in France, with a reduction in mortality and major bleeding140. Conversely, VKAs were also associated with higher all-cause mortality at 5 years in the Swiss TAVI registry, but with a lower incidence of disabling stroke not related to the procedure and no differences in major bleeding141.

Additionally, there are several meta-analyses based mainly on observational studies. One meta-analysis with over 30,000 patients from 3 randomized trials and 8 observational studies showed a reduction in major bleeding (RR 0.82 [0.77-0.88], p< 0.00001) and all-cause mortality (RR 0.83 [0.79-0.88], p < 0.00001) with the use of DOACs, with no differences in the occurrence of stroke142.

These findings suggest that DOACs could be an option as the first alternative to VKAs, though better quality evidence is needed to define the optimal management for these patients. In this regard, considering the FRAIL-AF study, switching from VKA to DOACs after implantation is not recommended in elderly patients (≥75 years) with frailty parameters who were already under VKA therapy143.

Also, combining antiplatelet therapy with anticoagulation is not advised. POPULAR-TAVI trial Cohort B demonstrated the non-inferiority of isolated DOAC compared to DOAC plus clopidogrel for 3 months in a composite endpoint of death, stroke, or myocardial infarction, with a 40-% reduction in bleeding144.

Finally, many patients undergoing TAVI have a high risk of bleeding, which may even lead to no indication for anticoagulant treatment in up to 40% of patients in some series145. For this reason, there has been growing interest in left atrial appendage closure as an alternative treatment, with limited evidence so far.

Indication for oral anticoagulation and recent angioplasty:

A history of recent (less than 3 months) coronary angioplasty and the consequent need for antiplatelet therapy carry an increased risk of bleeding after TAVI in patients with AF146. In the absence of specific evidence, the recommendation is to apply current antithrombotic management guidelines for patients with AF and coronary angioplasty, where DOACs are preferred over VKAs.

Additionally, prolonging triple antithrombotic therapy with ASA and a P2Y12 inhibitor beyond 1 week is discouraged, continuing with dual antithrombotic therapy. In cases of increased risk of stent thrombosis (e.g., complex lesions, multi-vessel disease, or a previous history of stent thrombosis), triple therapy could be extended up to 1 month after the procedure.

The ideal duration of combined treatment with DOACs and clopidogrel after TAVI is still uncertain. The most accepted strategy is to maintain both for 12 months in cases of angioplasty in acute coronary syndrome (ACS) and reduce it to 6 months when there is no ACS147-149.

However, there is growing evidence regarding the benefit and safety of short-duration antithrombotic therapy; consequently, experts suggest the shortest therapy possible (1-6 months), depending on the bleeding risk128. In this sense, high bleeding risk patients could receive 1 to 3 months of dual antithrombotic therapy in cases of chronic coronary syndrome and 3 to 6 months for acute coronary syndromes, followed by single anticoagulation therapy thereafter.

Valve thrombosis:

The optimal management of subclinical valvular thrombosis is uncertain, and so is its relationship with clinical events. While some reports suggest a good prognosis with a conservative approach over 5 years150, a systematic review and meta-analysis found a higher incidence of stroke and transient ischemic attack (RR 2.56 [1.60-4.09]; I2=0%; p < 0.00001)131.

In this regard, in the absence of high bleeding risk, a short anticoagulation therapy (3-6 months) would be justified151. Anticoagulant treatment is associated with a 94-% resolution of thrombosis and a 99-% increase in the probability of resolution compared to no anticoagulant treatment (odds ratio [OR]: 0.01 [0.00-0.06]; I2=36%; P < 0.00001)131. Conversely, in cases of high bleeding risk, a watchful waiting approach may be considered.

Furthermore, in cases of clinically manifest valve thrombosis, anticoagulant treatment should be continued for at least 3 to 6 months or until resolution.

13.2. Coronary access

Aortic stenosis and coronary artery disease share risk factors and pathogenesis, which means their association is common. TAVI patients have significant coronary artery disease in 40%-75% of cases152. Its presence can impact both procedural risk and subsequent prognosis.

The need for intervention after TAVI is an important factor to consider due to TAVI expansion to patients with lower surgical risk, younger age, and longer life expectancy. In this sense, preserving coronary access for potential future interventions has become essential.

13.2.1. Management of coronary artery disease and TAVI

The only clear scenario for revascularization in patients undergoing TAVI is acute coronary syndrome. In contrast, many questions about the management of stable coronary artery disease remain unanswered.

Various meta-analyses, primarily based on observational studies, have failed to demonstrate a clinical benefit from routine revascularization prior to TAVI, even showing an increase in bleeding with this strategy153, 154.

The first randomized study assessing the impact of revascularization prior to TAVI was the ACTIVATION study155. In this study, 235 patients with significant coronary artery disease and severe aortic stenosis were randomized to coronary angioplasty before TAVI or no angioplasty TAVI. After one year of follow-up, the percutaneous revascularization strategy did not achieve non-inferiority for the combined endpoint of all-cause death or hospitalization (41.5% vs. 44%; absolute difference -2.5%, p=0.067). There were no differences in the incidence of stroke, myocardial infarction, or kidney injury, although patients in the angioplasty group had a higher risk of bleeding (44.5% vs. 28.4%; p=0.021). It is important to note some limitations of the aforementioned study, such as insufficient statistical power to evaluate the primary combined endpoint, predominance of asymptomatic patients (69%), and predominance of patients with single-vessel disease (71%).

Later on, the randomized NOTION trial156 demonstrated that, in patients with obstructive coronary artery disease in at least one vessel and severe aortic stenosis undergoing TAVI, prior coronary revascularization proved beneficial when compared to optimal medical treatment. In the angioplasty group, the incidence of major adverse cardiac events (death, myocardial infarction, or urgent revascularization) was significantly lower compared to the conservative therapy group (26% vs. 36%, p=0.04). This difference was primarily driven by a reduction in the rate of myocardial infarction and the need for urgent revascularization.

Finally, it is important to consider the significant risk of acute coronary syndrome after TAVI, especially in an increasingly younger population, with a worse prognosis compared to other scenarios157. Only one-third of patients with post-TAVI acute coronary syndrome are revascularized, and lack of revascularization is associated with a worse prognosis. This emphasizes the need to identify a better strategy and optimize implantation technique and valve design to preserve coronary access.

Given all this, there is general consensus recommending coronary revascularization in patients with severe coronary artery disease of the main vessels, particularly in the case of acute coronary syndrome, chest pain, or sub-occlusive lesions (>90%), with ischemia demonstrated by invasive physiology or with features of vulnerability16, 158, 159.

13.2.2. Timing for revascularization

The optimal timing for revascularization is also uncertain. Each of the possible approaches has its advantages and disadvantages (Table 5). While there is evidence suggesting that performing both procedures together is feasible and safe, the currently most accepted option is performing coronary angioplasty prior to valve implantation16, 158.

This recommendation is mainly driven by the potential challenge of re-accessing the coronary arteries after TAVI, with reports of failure in selective coronary cannulation of up to 50%, primarily with the first generations of supra-annular self-expanding valves120.

13.2.3. Coronary access after TAVI

Valve design, particularly stent frame height and leaflet position, can affect future coronary access. Therefore, thorough knowledge of available devices and their implantation techniques is essential to ensure proper commissural alignment. In general, self-expanding valves with a high stent frame and supra-annular leaflet position are more challenging, especially in cases of poor commissural alignment or high implantation160.

It is important to note that coronary access after TAVI is also influenced by several critical anatomical factors, such as sinus size (particularly in relation to the size of the implanted valve), sinotubular junction height and width, and coronary location in terms of height and relation to native commissures.

Commissural alignment

Commissural alignment is defined as the relation between the native and prosthetic commissures after valve implantation. Achieving alignment during valve implantation is necessary to improve the success rate of selective coronary angiography after TAVI while reducing contrast volume and procedure time161. Additionally, it may impact valve hemodynamics and has important implications if a TAVI-to-TAVI procedure is needed.

There are specific steps to ensure proper implantation of each valve, but those go beyond the purpose of this document. Specific texts158, 162 should be consulted; however, some general guidelines have been outlined below.

• Evolut platform: insert the release system with the wash port at 3 o’clock. During positioning in a left-right cuspoverlap projection, the “hatmarker” should face forward. Once implanted, the “C-paddle” should be visible on the right side of the screen in the same projection.

• Acurate Neo platform: insert the release system with the wash port at 6 o’clock. During positioning, the free stent strut should be visible on the right side of the screen in the cuspoverlap projection.

• Navitor platform: insert the release system with the wash port at 12 o’clock. During positioning, a fine single marker on the right (single post) and a thick line corresponding to the remaining overlapping posts on the left should be visible in the cuspoverlap projection.

Tips and tricks for coronary access after TAVI

In general, coronary access after the implantation of a balloon-expandable valve with shorter stent length and intra-annular design does not require any change in the usual techniques.

On the other hand, proper planning is necessary in the case of high-frame valves, especially in cases with small Valsalva sinuses and low coronary take-off. In these cases, left transradial or transfemoral approach is recommended to facilitate passage through the stents. Additionally, selective angiography is usually more easily achieved with catheters with smaller curve sizes, prioritizing 6-Fr catheters to facilitate manipulation163.

In cases of difficult cannulation, advancing a coronary guidewire to perform a selective injection may be helpful164. Moreover, using guidewire catheter extensions can improve support in cases of angioplasty with non-selective cannulation163.

Finally, catheter removal should be done over a guidewire to avoid using excessive force, thus preventing catheter kinking or valve displacement. In case of entrapment, using a coronary balloon may help.

13.3. Follow-up of TAVI patients

It is essential that all patients undergoing TAVI continue follow-up under the supervision of a clinical cardiologist specialized in valvular heart disease or an interventional cardiologist, so as to potentially detect early prosthesis deterioration, left ventricular systolic dysfunction, or concomitant disease in other valves15, 165.

After TAVI, transthoracic echocardiogram (TTE) is recommended 30 days after discharge and at one year, continuing with annual clinical and echocardiographic follow-ups afterwards166. A TTE should also be performed if there is suspicion of a complication or the onset of new symptoms. In cases of an increase in the transvalvular gradient >20 mmHg, a CT angiogram is suggested to rule out hypoattenuated leaflet thickening (HALT). The patient should be referred to a center with experience in complications.

In cases where prosthetic dysfunction is suspected, a transesophageal echocardiogram is recommended, and the patient should be referred to centers with experience in managing TAVI complications and cardiovascular surgery for TAVI explant, to be assessed by a Heart Team165.

Infective endocarditis (IE) is a rare but serious complication that can arise after transcatheter aortic valve replacement. Despite significant advancements in the TAVI procedure, making it less invasive and expanding it to younger and healthier patients, the incidence of post-TAVI IE remains stable, with rates similar to those observed after surgical aortic valve replacement. Although post-TAVI IE is recognized as a subtype of prosthetic valve endocarditis, this condition presents a particular clinical challenge due to its unique clinical and microbiological profile, high complication rate, and elevated mortality. With the expected increase in the number of TAVI procedures in the coming years, the number of patients at risk of developing this potentially fatal complication is also expected to rise. Therefore, it is crucial to thoroughly understand this disease and its complications to improve clinical outcomes. More research is needed to optimize antibiotic prophylaxis protocols, assess new imaging techniques for diagnosis, identify patients at higher risk for adverse outcomes, and clarify the indications for surgical intervention in patients with post-TAVI IE.

The definition, diagnosis, and staging of bioprosthetic valve dysfunction and failure are beyond the scope of this expert consensus.

Recommendations	Class	Level of evidence
Follow up with a cardiologist experienced in valvular heart disease or an interventional cardiologist after TAVI.	I	C
Transthoracic echocardiogram 30 days after implantation, at one year, and then annually so as to diagnose TAVI dysfunction early.	I	C

14. Special situations

14.1 TAVI in bicuspid aortic valve

Bicuspid aortic valve (BAV) is the most common congenital heart disease, with a prevalence of 0.5%-2%167. Its most common complication is severe aortic stenosis (SAS), which typically emerges in middle age168.

The most widely used classification today is that by Sievers51, which considers the number of raphes , the spatial distribution of the free edge of the leaflets, and the functional status of the valve (stenosis and/or regurgitation). The Sievers LR type, with a single raphe merging the left and right coronary leaflets, is the most common type, accounting for 71% of all bicuspid aortic valve cases.

With the advancement of multislice CT, a new morphological classification has been created: tricommissural BAV, bicommissural BAV raphe type, and bicommissural BAV non-raphe type. This classification simplifies leaflet orientation depending on whether the fusion occurs between coronary cusps or between a coronary cusp and the non-coronary cusp. Notably, bicommissural BAVs tend to be larger compared to tricommisural BAVs, which should be considered when planning TAVI52.

TAVI in this scenario presents certain technical challenges, such as larger size of the aortic valve complex169, elliptical supra-annular geometry170, leaflet fusion accompanied by significant and eccentric calcification—which makes correct implantation more difficult—, higher gradients, paravalvular regurgitation, and atrioventricular conduction disorders171.

The introduction of next-generation devices, growing operator experience, and better pre-procedural planning based on computed tomography have substantially improved outcomes172.

This was demonstrated with the latest self-expanding valves in different analyses compared to tricuspid aortic valves, showing similar 30-day and one-year mortality and stroke rates, but a higher occurrence of moderate or severe leak and permanent pacemaker implantation173, 174.

Balloon-expandable valves were assessed in the SAPIENS 3 bicuspid valve registry, showing similar outcomes at 12 months in mortality, infarction, stroke, presence of moderate or severe leak, reintervention, and pacemaker implantation174.

At 3 years, there was no difference in mortality or major events between balloon-expandable and self-expanding valves, but self-expanding valves showed a lower gradient with no difference in the presence of moderate or severe leak175.

Currently, balloon-expandable valves remain the treatment of choice in this scenario. TAVI is recommended as the treatment of choice for high surgical risk patients with favorable anatomy for TAVI.

Recommendations	Class	Level of evidence
In patients with bicuspid aortic valve and severe stenosis requiring intervention, surgical aortic valve replacement is recommended.	IIb	C
In patients with bicuspid aortic valve and severe stenosis, an indication for intervention, and high surgical risk, TAVI is recommended at experienced centers.	IIb	C

14.2. TAVI in aortic regurgitation

The prevalence of pure aortic regurgitation (AR) is around 2% in the population over 70 years of age176. Currently, aortic valve replacement (AVR) is recommended for patients with moderate/severe AR with symptoms of heart failure or left ventricular dysfunction or dilation, or based on echocardiographic and/or cardiac MRI parameters15. However, in patients at high surgical risk, TAVI becomes a viable option.

However, this scenario presents certain unresolved challenges related to anatomical differences with aortic stenosis and the lack of calcium, as TAVI devices have not been designed for this condition. This complicates implantation and increases the risk of displacement into the left ventricle or the aorta.

Published analyses on the initial experience with valves designed for aortic stenosis showed that, in high-risk surgical patients, this strategy was feasible and safe174, 177-179.

However, the choice for the best device in this context remains unclear. While self-expanding valves would theoretically have the advantage of offering larger sizes and the possibility of repositioning, current results comparing them with balloon-expandable valves suggest lower device success, higher post-procedural significant aortic regurgitation, and greater need for permanent pacemaker implantation. This positions balloon-expandable valves as a potentially more attractive alternative. While there are no official recommendations, a 20-30-% oversizing is commonly used to ensure valve anchoring and avoid embolization, although this could increase the risk of complications such as conduction disturbances or annular rupture180.

Among balloon-expandable valves, MyVal (Meril LifeSciences) currently offers a wider range of devices for this scenario. In a study with a 5-year follow-up, it proved to be safe and effective, with a high procedural success rate, low major complication rate, a 22-% rate of need for pacemaker implantation, and good durability181.

A meta-analysis of 11 studies, including 911 patients from initial studies regarding this scenario, offered a device success rate of 80.4%, moderate or higher aortic regurgitation in 7.4% of patients, and a 30-day mortality rate of 9.5%, with up to 3% of subjects requiring crossover to open surgery182.

Development of AR-dedicated devices is currently ongoing. One of them is the J-Valve (JC Medical) self-expanding valve. This device was shown to be safe and effective with significant improvements in functional class and hemodynamic performance after one year183.

Percutaneous treatment of AR remains a real challenge. While the results with devices designed for aortic stenosis are encouraging, percutaneous treatment should be reserved for cases contraindicated for conventional surgery and at specialized centers with experience in percutaneous implantation for this condition.

1. d’Arcy JL, Coffey S, Loudon MA, et al. Large-scale community echocardiographic screening reveals a major burden of undiagnosed valvular heart disease in older people: the OxVALVE Population Cohort Study. Eur Heart J 2016;37(47):3515–22.

2. Osnabrugge RLJ, Mylotte D, Head SJ, et al. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol 2013;62(11):1002–12.

3. Abud M, Miembro del CACI, Candiello A, et al. Actualización 2019 del Consenso sobre Implante Valvular Aórtico Percutáneo del Colegio Argentino de Cardioangiólogos Intervencionistas. Rev Argent CardioangiolInterv 2019;10(04):0150–69.

4. Burzotta F, Graziani F, Trani C, et al. Clinical Impact of Heart Team Decisions for Patients With Complex Valvular Heart Disease: A Large, Single-Center Experience. J Am Heart Assoc 2022;11(11):e024404.

5. Afilalo J, Lauck S, Kim DH, et al. Frailty in Older Adults Undergoing Aortic Valve Replacement: The FRAILTY-AVR Study. J Am Coll Cardiol 2017;70(6):689–700.

6. Kundi H, Popma JJ, Reynolds MR, et al. Frailty and related outcomes in patients undergoing transcatheter valve therapies in a nationwide cohort. Eur Heart J 2019;40(27):2231–9.

7. Hosler QP, Maltagliati AJ, Shi SM, et al. A Practical Two-Stage Frailty Assessment for Older Adults Undergoing Aortic Valve Replacement. J Am Geriatr Soc 2019;67(10):2031–7.

8. Dent E, Martin FC, Bergman H, Woo J, Romero-Ortuno R, Walston JD. Management of frailty: opportunities, challenges, and future directions. Lancet 2019;394(10206):1376–86.

9. Fried LP, Tangen CM, Walston J, et al. Frailty in older adults: evidence for a phenotype. J GerontolA Biol Sci Med Sci 2001;56(3):M146–56.

10. Baritello O, Salzwedel A, Sündermann SH, Niebauer J, Völler H. The Pandora’s Box of Frailty Assessments: Which Is the Best for Clinical Purposes in TAVI Patients? A Critical Review. J Clin Med Res [Internet] 2021;10(19). Available from: http://dx.doi.org/10.3390/jcm10194506

11. Romeo FJ, Smietniansky M, Cal M, et al. Measuring frailty in patients with severe aortic stenosis: a comparison of the edmonton frail scale with modified fried frailty assessment in patients undergoing transcatheter aortic valve replacement. J GeriatrCardiol 2020;17(7):441–6.

12. Amador AF. Edmonton frail scale in TAVI patients: A new tool for frailty assessment and outcomes prediction. Int J Cardiol2024;407:132024.

13. Tzoumas A, Kokkinidis DG, Giannopoulos S, et al. Frailty in patients undergoing transcatheter aortic valve replacement: from risk scores to frailty-based management. J GeriatrCardiol 2021;18(6):479–86.

14. Van de Velde-Van De Ginste S, Perkisas S, Vermeersch P, Vandewoude M, De Cock A-M. Physical components of frailty in predicting mortality after transcatheter aortic valve implantation (TAVI). Acta Cardiol 2021;76(7):681–8.

15. Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J 2022;43(7):561–632.

16. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2021;143(5):e35–71.

17. Lamelas P, Ragusa MA, Bagur R, et al. Clinical practice guideline for transcatheter versus surgical valve replacement in patients with severe aortic stenosis in Latin America. Heart 2021;107(18):1450–7.

18. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363(17):1597–607.

19. Deeb GM, Reardon MJ, Chetcuti S, et al. 3-Year Outcomes in High-Risk Patients Who Underwent Surgical or Transcatheter Aortic Valve Replacement. J Am Coll Cardiol 2016;67(22):2565–74.

20. Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 2014;370(19):1790–8.

21. Thyregod HGH, Steinbrüchel DA, Ihlemann N, et al. Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis: 1-Year Results From the All-Comers NOTION Randomized Clinical Trial. J Am Coll Cardiol 2015;65(20):2184–94.

22. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med 2016;374(17):1609–20.

23. Thourani VH, Kodali S, Makkar RR, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet 2016;387(10034):2218–25.

24. Makkar RR, Thourani VH, Mack MJ, et al. Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement. N Engl J Med 2020;382(9):799–809.

25. Thyregod HGH, Ihlemann N, Jørgensen TH, et al. Five-Year Clinical and Echocardiographic Outcomes From the NOTION Randomized Clinical Trial in Patients at Lower Surgical Risk. Circulation 2019;139(24):2714–23.

26. Siontis GCM, Overtchouk P, Cahill TJ, et al. Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of symptomatic severe aortic stenosis: an updated meta-analysis. Eur Heart J 2019;40(38):3143–53.

27. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med 2019;380(18):1695–705.

28. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med 2019;380(18):1706–15.

29. Leon MB, Mack MJ, Hahn RT, et al. Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk. J Am Coll Cardiol 2021;77(9):1149–61.

30. Thyregod HGH, Jørgensen TH, Ihlemann N, et al. Transcatheter or surgical aortic valve implantation: 10-year outcomes of the NOTION trial. Eur Heart J 2024;45(13):1116–24.

31. Asgar AW, Ouzounian M, Adams C, et al. 2019 Canadian Cardiovascular Society Position Statement for Transcatheter Aortic Valve Implantation. Can J Cardiol 2019;35(11):1437–48.

32. Lind A, Totzeck M, Mahabadi AA, et al. Impact of Cancer in Patients Undergoing Transcatheter Aortic Valve Replacement: A Single-Center Study. JACC CardioOncol 2020;2(5):735–43.

33. van Kesteren F, Wiegerinck EMA, van Mourik MS, et al. Impact of Potentially Malignant Incidental Findings by Computed Tomographic Angiography on Long-Term Survival After Transcatheter Aortic Valve Implantation. Am J Cardiol 2017;120(6):994–1001.

34. Balloon Aortic Valvuloplasty in the Modern Era: A Review of Outcomes, Indications, and Technical Advances. Catheter Cardiovasc Interv 2023;2(4):101002.

35. Kumar A, Shah R, Young LD, et al. Safety and efficacy of balloon aortic valvuloplasty stratified by acuity of patient illness. Struct Heart 2021;5(5):520–9.

36. Tumscitz C, Campo G, Tebaldi M, Gallo F, Pirani L, Biscaglia S. Safety and Feasibility of Transradial Mini-Invasive Balloon Aortic Valvuloplasty: A Pilot Study. JACC CardiovascInterv 2017;10(13):1375–7.

37. Tumscitz C, Di Cesare A, Balducelli M, et al. Safety, efficacy and impact on frailty of mini-invasive radial balloon aortic valvuloplasty. Heart 2021;107(11):874–80.

38. Di Cesare A, Tonet E, Campo G, Tumscitz C. Snuffbox approach for balloon aortic valvuloplasty: A case series. Catheter Cardiovasc Interv 2021;97(5):E743–7.

39. Medina DE Chazal HA, Seropian IM, Romeo F, et al. Balloon aortic valvuloplasty through the novel transradial technique. Minerva CardiolAngiol 2021;69(4):458–63.

40. Debry N, Altes A, Vincent F, et al. Balloon aortic valvuloplasty for severe aortic stenosis before urgent non-cardiac surgery. EuroIntervention 2021;17(8):e680–7.

41. Abbara S, Blanke P, Maroules CD, et al. SCCT guidelines for the performance and acquisition of coronary computed tomographic angiography: A report of the society of Cardiovascular Computed Tomography Guidelines Committee: Endorsed by the North American Society for Cardiovascular Imaging (NASCI). J Cardiovasc ComputTomogr 2016;10(6):435–49.

42. Jurencak T, Turek J, Kietselaer BLJH, et al. MDCT evaluation of aortic root and aortic valve prior to TAVI. What is the optimal imaging time point in the cardiac cycle? EurRadiol 2015;25(7):1975–83.

43. Blanke P, Weir-McCall JR, Achenbach S, et al. Computed Tomography Imaging in the Context of Transcatheter Aortic Valve Implantation (TAVI)/Transcatheter Aortic Valve Replacement (TAVR): An Expert Consensus Document of the Society of Cardiovascular Computed Tomography. JACC Cardiovasc Imaging 2019;12(1):1–24.

44. Achenbach S, Delgado V, Hausleiter J, Schoenhagen P, Min JK, Leipsic JA. SCCT expert consensus document on computed tomography imaging before transcatheter aortic valve implantation (TAVI)/transcatheter aortic valve replacement (TAVR). J Cardiovasc ComputTomogr 2012;6(6):366–80.

45. Blanke P, Willson AB, Webb JG, et al. Oversizing in transcatheter aortic valve replacement, a commonly used term but a poorly understood one: dependency on definition and geometrical measurements. J Cardiovasc ComputTomogr 2014;8(1):67–76.

46. Hansson NC, Nørgaard BL, Barbanti M, et al. The impact of calcium volume and distribution in aortic root injury related to balloon-expandable transcatheter aortic valve replacement. J Cardiovasc ComputTomogr 2015;9(5):382–92.

47. Thériault-Lauzier P, Andalib A, Martucci G, et al. Fluoroscopic anatomy of left-sided heart structures for transcatheter interventions: insight from multislice computed tomography. JACC Cardiovasc Interv 2014;7(9):947–57.

48. Ewe SH, Ng ACT, Schuijf JD, et al. Location and severity of aortic valve calcium and implications for aortic regurgitation after transcatheter aortic valve implantation. Am J Cardiol 2011;108(10):1470–7.

49. Fujita B, Kütting M, Seiffert M, et al. Calcium distribution patterns of the aortic valve as a risk factor for the need of permanent pacemaker implantation after transcatheter aortic valve implantation. Eur Heart J Cardiovasc Imaging 2016;17(12):1385–93.

50. Gorla R, De Marco F, Garatti A, et al. Impact of aortic angle on transcatheter aortic valve implantation outcome with Evolut-R, Portico, and Acurate-NEO. Catheter Cardiovasc Interv 2021;97(1):E135–45.

51. Sievers H-H, Schmidtke C. A classification system for the bicuspid aortic valve from 304 surgical specimens. J Thorac Cardiovasc Surg 2007;133(5):1226–33.

52. Jilaihawi H, Chen M, Webb J, et al. A Bicuspid Aortic Valve Imaging Classification for the TAVR Era. JACC Cardiovasc Imaging 2016;9(10):1145–58.

53. Mylotte D, Lefevre T, Søndergaard L, et al. Transcatheter aortic valve replacement in bicuspid aortic valve disease. J Am Coll Cardiol 2014;64(22):2330–9.

54. Tchetche D, de Biase C, van Gils L, et al. Bicuspid Aortic Valve Anatomy and Relationship With Devices: The BAVARD Multicenter Registry. CircCardiovascInterv 2019;12(1):e007107.

55. Iannopollo G, Romano V, Buzzatti N, et al. Supra-annular sizing of transcatheter aortic valve prostheses in raphe-type bicuspid aortic valve disease: the LIRA method. Int J Cardiol2020;317:144–51.

56. Petronio AS, Angelillis M, De Backer O, et al. Bicuspid aortic valve sizing for transcatheter aortic valve implantation: Development and validation of an algorithm based on multi-slice computed tomography. J CardiovascComputTomogr 2020;14(5):452–61.

57. Blackman D, Gabbieri D, Del Blanco BG, et al. Expert Consensus on Sizing and Positioning of SAPIEN 3/Ultra in Bicuspid Aortic Valves. CardiolTher 2021;10(2):277–88.

58. Fankhauser CD, Nietlispach F, Emmert MY, Maisano F. Antegrade valve embolization after transcatheter treatment for pure aortic regurgitation. Eur Heart J 2016;37(10):856.

59. Carroll JD, Mack MJ, Vemulapalli S, et al. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol 2020;76(21):2492–516.

60. Tamburino C, Capodanno D, Ramondo A, et al. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation 2011;123(3):299–308.

61. Basir MB, Velez C, Fuller B, et al. Rates of vascular access use in transcatheter aortic valve replacement: A look into the next generation. Catheter Cardiovasc Interv 2016;87(4):E166–71.

62. Koehler T, Buege M, Schleiting H, Seyfarth M, Tiroch K, Vorpahl M. Changes of the eSheath Outer Dimensions Used for Transfemoral Transcatheter Aortic Valve Replacement. Biomed Res Int 2015;2015:572681.

63. Koren O, Patel V, Tamir Y, et al. Predicting the risk of iliofemoral vascular complication in complex transfemoral-TAVR using new generation transcatheter devices. Front Cardiovasc Med 2023;10:1167212.

64. Manunga JM, Gloviczki P, Oderich GS, et al. Femoral artery calcification as a determinant of success for percutaneous access for endovascular abdominal aortic aneurysm repair. J Vasc Surg 2013;58(5):1208–12.

65. Mach M, Okutucu S, Kerbel T, et al. Vascular Complications in TAVR: Incidence, Clinical Impact, and Management. J Clin Med Res [Internet] 2021;10(21). Available from: http://dx.doi.org/10.3390/jcm10215046

66. Gennari M, Maccarana A, Severgnini G, et al. See It Best: A Propensity-Matched Analysis of Ultrasound-Guided versus Blind Femoral Artery Puncture in Balloon-Expandable TAVI. J Clin Med Res [Internet] 2024;13(5). Available from: http://dx.doi.org/10.3390/jcm13051514

67. Thiele H, Kurz T, Feistritzer H-J, et al. Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: the randomized SOLVE-TAVI trial. Eur Heart J 2020;41(20):1890–9.

68. Costa G, Saia F, Pilgrim T, et al. Transcatheter Aortic Valve Replacement With the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry. JACC Cardiovasc Interv 2022;15(23):2398–407.

69. Herrmann HC, Mehran R, Blackman DJ, et al. Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus. N Engl J Med 2024;390(21):1959–71.

70. Rodés-Cabau J, Abbas AE, Serra V, et al. Balloon- vs Self-Expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses. J Am Coll Cardiol 2022;80(7):681–93.

71. Katsaros O, Apostolos A, Ktenopoulos N, et al. Transcatheter Aortic Valve Implantation Access Sites: Same Goals, Distinct Aspects, Various Merits and Demerits. J Cardiovasc Dev Dis [Internet] 2023;11(1). Available from: http://dx.doi.org/10.3390/jcdd11010004

72. Nardi G, De Backer O, Saia F, et al. Peripheral intravascular lithotripsy for transcatheter aortic valve implantation: a multicentre observational study. EuroIntervention 2022;17(17):e1397–406.

73. Alvarez-Covarrubias HA, Joner M, Cassese S, et al. Iliofemoral artery predilation prior to transfemoral transcatheter aortic valve implantation in patients with aortic valve stenosis and advanced peripheral artery disease. CatheterCardiovascInterv 2023;101(3):628–38.

74. Ueshima D, Barioli A, Nai Fovino L, et al. The impact of pre-existing peripheral artery disease on transcatheter aortic valve implantation outcomes: A systematic review and meta-analysis. Catheter Cardiovasc Interv 2020;95(5):993–1000.

75. Xenogiannis I, Varlamos C, Keeble TR, Kalogeropoulos AS, Karamasis GV. Ultrasound-Guided Femoral Vascular Access for Percutaneous Coronary and Structural Interventions. Diagnostics (Basel) [Internet] 2023;13(12). Available from: http://dx.doi.org/10.3390/diagnostics13122028

76. Moriyama N, Lindström L, Laine M. Propensity-matched comparison of vascular closure devices after transcatheter aortic valve replacement using MANTA versus ProGlide. EuroIntervention 2019;14(15):e1558–65.

77. Barbash IM, Wasserstrum Y, Erlebach M, et al. Comparison of MANTA versus Perclose Prostyle large-bore vascular closure devices during transcatheter aortic valve implantation. Catheter Cardiovasc Interv 2024;103(1):160–8.

78. Rosseel L, Montarello NJ, Nuyens P, et al. A systematic algorithm for large-bore arterial access closure after TAVI: the TAVI-MultiCLOSE study. EuroIntervention 2024;20(6):e354–62.

79. Bapat V, Tang GHL. Axillary/Subclavian Transcatheter Aortic Valve Replacement: The Default Alternative Access? JACC Cardiovasc Interv 2019;12(7):670–2.

80. Gleason TG, Schindler JT, Hagberg RC, et al. Subclavian/Axillary Access for Self-Expanding Transcatheter Aortic Valve Replacement Renders Equivalent Outcomes as Transfemoral. Ann Thorac Surg 2018;105(2):477–83.

81. Arnett DM, Lee JC, Harms MA, et al. Caliber and fitness of the axillary artery as a conduit for large-bore cardiovascular procedures. Catheter Cardiovasc Interv 2018;91(1):150–6.

82. Mathur M, Zack CJ, Heatley A, et al. A “fully upper extremity” bailout of direct transaxillary large bore arterial access: A refinement within arm’s reach? CatheterCardiovascInterv 2021;98(6):E918–21.

83. Harloff MT, Percy ED, Hirji SA, et al. A step-by-step guide to trans-axillary transcatheter aortic valve replacement. Ann Cardiothorac Surg 2020;9(6):510–21.

84. Faroux L, Junquera L, Mohammadi S, et al. Femoral Versus Nonfemoral Subclavian/Carotid Arterial Access Route for Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis. J Am Heart Assoc 2020;9(19):e017460.

85. Villecourt A, Faroux L, Muneaux A, et al. Comparison of clinical outcomes after transcarotid and transsubclavian versus transfemoral transcatheter aortic valve implantation: A propensity-matched analysis. Arch Cardiovasc Dis 2020;113(3):189–98.

86. Lederman RJ, Babaliaros VC, Rogers T, et al. The Fate of Transcaval Access Tracts: 12-Month Results of the Prospective NHLBI Transcaval Transcatheter Aortic Valve Replacement Study. JACC Cardiovasc Interv 2019;12(5):448–56.

87. Greenbaum AB, Babaliaros VC, Chen MY, et al. Transcaval Access and Closure for Transcatheter Aortic Valve Replacement: A Prospective Investigation. J Am Coll Cardiol 2017;69(5):511–21.

88. Barbash IM, Segev A, Berkovitch A, et al. Clinical Outcome and Safety of Transcaval Access for Transcatheter Aortic Valve Replacement as Compared to Other Alternative Approaches. Front Cardiovasc Med 2021;8:731639.

89. Athappan G, Patvardhan E, Tuzcu EM, et al. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature. J Am Coll Cardiol 2013;61(15):1585–95.

90. Hagar A, Li Y, Wei X, et al. Incidence, Predictors, and Outcome of Paravalvular Leak after Transcatheter Aortic Valve Implantation. J IntervCardiol2020;2020:8249497.

91. Van Belle E, Juthier F, Susen S, et al. Postprocedural aortic regurgitation in balloon-expandable and self-expandable transcatheter aortic valve replacement procedures: analysis of predictors and impact on long-term mortality: insights from the FRANCE2 Registry. Circulation 2014;129(13):1415–27.

92. VARC-3 WRITING COMMITTEE, Généreux P, Piazza N, et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J 2021;42(19):1825–57.

93. Sá MP, Jacquemyn X, Van den Eynde J, et al. Impact of Paravalvular Leak on Outcomes After Transcatheter Aortic Valve Implantation: Meta-Analysis of Kaplan-Meier-derived Individual Patient Data. Struct Heart 2023;7(2):100118.

94. Sakrana AA, Nasr MM, Ashamallah GA, Abuelatta RA, Naeim HA, Tahlawi ME. Paravalvular leak after transcatheter aortic valve implantation: is it anatomically predictable or procedurally determined? MDCT study. Clin Radiol 2016;71(11):1095–103.

95. Sinning J-M, Hammerstingl C, Vasa-Nicotera M, et al. Aortic regurgitation index defines severity of peri-prosthetic regurgitation and predicts outcome in patients after transcatheter aortic valve implantation. J Am Coll Cardiol 2012;59(13):1134–41.

96. Höllriegel R, Woitek F, Stativa R, et al. Hemodynamic Assessment of Aortic Regurgitation After Transcatheter Aortic Valve Replacement: The Diastolic Pressure-Time Index. JACC CardiovascInterv 2016;9(10):1061–8.

97. Zoghbi WA, Asch FM, Bruce C, et al. Guidelines for the Evaluation of Valvular Regurgitation After Percutaneous Valve Repair or Replacement: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Angiography and Interventions, Japanese Society of Echocardiography, and Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr 2019;32(4):431–75.

98. Stundl A, Rademacher M-C, Descoups C, et al. Balloon post-dilation and valve-in-valve implantation for the reduction of paravalvular leakage with use of the self-expanding CoreValve prosthesis. EuroIntervention 2016;11(10):1140–7.

99. Flores-Umanzor E, Nogic J, Cepas-Guillén P, et al. Percutaneous paravalvular leak closure after transcatheter aortic valve implantation: the international PLUGinTAVI Registry. EuroIntervention 2023;19(5):e442–9.

100. Auffret V, Puri R, Urena M, et al. Conduction Disturbances After Transcatheter Aortic Valve Replacement: Current Status and Future Perspectives. Circulation 2017;136(11):1049–69.

101. Kawashima T, Sato F. Visualizing anatomical evidences on atrioventricular conduction system for TAVI. Int J Cardiol 2014;174(1):1–6.

102. Auffret V, Webb JG, Eltchaninoff H, et al. Clinical Impact of Baseline Right Bundle Branch Block in Patients Undergoing Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv 2017;10(15):1564–74.

103. Hokken TW, Muhemin M, Okuno T, et al. Impact of membranous septum length on pacemaker need with different transcatheter aortic valve replacement systems: The INTERSECT registry. J CardiovascComputTomogr 2022;16(6):524–30.

104. Mangieri A, Lanzillo G, Bertoldi L, et al. Predictors of Advanced Conduction Disturbances Requiring a Late (≥48 H) Permanent Pacemaker Following Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv 2018;11(15):1519–26.

105. Ochiai T, Yamanaka F, Shishido K, et al. Impact of High Implantation of Transcatheter Aortic Valve on Subsequent Conduction Disturbances and Coronary Access. JACC Cardiovasc Interv 2023;16(10):1192–204.

106. Wienemann H, Maier O, Beyer M, et al. Cusp overlap versus standard three-cusp technique for self-expanding Evolut transcatheter aortic valves. EuroIntervention 2023;19(2):e176–87.

107. Mendiz OA, Fava C, Müller LI, et al. Predictors of permanent pacemaker implantation for transcatheter self-expandable aortic valve implant in the cusp overlap era. Catheter Cardiovasc Interv [Internet] 2024;Available from: http://dx.doi.org/10.1002/ccd.31176

108. Muntané-Carol G, Urena M, Nombela-Franco L, et al. Arrhythmic burden in patients with new-onset persistent left bundle branch block after transcatheter aortic valve replacement: 2-year results of the MARE study. Europace 2021;23(2):254–63.

109. Regueiro A, Abdul-JawadAltisent O, Del Trigo M, et al. Impact of New-Onset Left Bundle Branch Block and Periprocedural Permanent Pacemaker Implantation on Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis. Circ Cardiovasc Interv 2016;9(5):e003635.

110. Bourenane H, Galand V, Boulmier D, et al. Electrophysiological Study-Guided Permanent Pacemaker Implantation in Patients With Conduction Disturbances Following Transcatheter Aortic Valve Implantation. Am J Cardiol2021;149:78–85.

111. Généreux P, Webb JG, Svensson LG, et al. Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTicTraNscathetER Valve) trial. J Am Coll Cardiol 2012;60(12):1043–52.

112. Holmes DR Jr, Nishimura RA, Grover FL, et al. Annual Outcomes With Transcatheter Valve Therapy: From the STS/ACC TVT Registry. J Am Coll Cardiol 2015;66(25):2813–23.

113. Abdelaziz HK, Megaly M, Debski M, et al. Meta-Analysis Comparing Percutaneous to Surgical Access in Trans-Femoral Transcatheter Aortic Valve Implantation. Am J Cardiol 2020;125(8):1239–48.

114. Hayashida K, Lefèvre T, Chevalier B, et al. Transfemoral aortic valve implantation new criteria to predict vascular complications. JACC Cardiovasc Interv 2011;4(8):851–8.

115. Mastoris I, Schoos MM, Dangas GD, Mehran R. Stroke after transcatheter aortic valve replacement: incidence, risk factors, prognosis, and preventive strategies. Clin Cardiol 2014;37(12):756–64.

116. Zahid S, Ullah W, Zia Khan M, et al. Cerebral Embolic Protection during Transcatheter Aortic Valve Implantation: Updated Systematic Review and Meta-Analysis. CurrProblCardiol 2023;48(6):101127.

117. Kapadia SR, Makkar R, Leon M, et al. Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement. N Engl J Med 2022;387(14):1253–63.

118. Lansky AJ, Schofer J, Tchetche D, et al. A prospective randomized evaluation of the TriGuardTM HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial. Eur Heart J 2015;36(31):2070–8.

119. Haussig S, Mangner N, Dwyer MG, et al. Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial. JAMA 2016;316(6):592–601.

120. Faroux L, Guimaraes L, Wintzer-Wehekind J, et al. Coronary Artery Disease and Transcatheter Aortic Valve Replacement: JACC State-of-the-Art Review. J Am Coll Cardiol 2019;74(3):362–72.

121. Bajaj A, Pancholy S, Sethi A, Rathor P. Safety and feasibility of PCI in patients undergoing TAVR: A systematic review and meta-analysis. Heart Lung 2017;46(2):92–9.

122. Chakravarty T, Sharma R, Abramowitz Y, et al. Outcomes in Patients With Transcatheter Aortic Valve Replacement and Left Main Stenting: The TAVR-LM Registry. J AmCollCardiol 2016;67(8):951–60.

123. Ribeiro HB, Nombela-Franco L, Urena M, et al. Coronary obstruction following transcatheter aortic valve implantation: a systematic review. JACC Cardiovasc Interv 2013;6(5):452–61.

124. Ribeiro HB, Rodés-Cabau J, Blanke P, et al. Incidence, predictors, and clinical outcomes of coronary obstruction following transcatheter aortic valve replacement for degenerative bioprosthetic surgical valves: insights from the VIVID registry. Eur Heart J 2018;39(8):687–95.

125. Blanke P, Soon J, Dvir D, et al. Computed tomography assessment for transcatheter aortic valve in valve implantation: The vancouver approach to predict anatomical risk for coronary obstruction and other considerations. J Cardiovasc ComputTomogr 2016;10(6):491–9.

126. Lederman RJ, Babaliaros VC, Rogers T, et al. Preventing Coronary Obstruction During Transcatheter Aortic Valve Replacement: From Computed Tomography to BASILICA. JACC Cardiovasc Interv 2019;12(13):1197–216.

127. Kawashima H, Numasawa Y, Hayakawa N, et al. Review of Bleeding and Thrombotic Risks Associated With Antithrombotic Therapy After Transcatheter Structural Heart Interventions. JACC Asia 2024;4(1):1–9.

128. Ten Berg J, Sibbing D, Rocca B, et al. Management of antithrombotic therapy in patients undergoing transcatheter aortic valve implantation: a consensus document of the ESC Working Group on Thrombosis and the European Association of Percutaneous Cardiovascular Interventions (EAPCI), in collaboration with the ESC Council on Valvular Heart Disease. Eur Heart J 2021;42(23):2265–9.

129. Sannino A, Gargiulo G, Schiattarella GG, et al. A meta-analysis of the impact of pre-existing and new-onset atrial fibrillation on clinical outcomes in patients undergoing transcatheter aortic valve implantation. EuroIntervention 2016;12(8):e1047–56.

130. Ryan T, Grindal A, Jinah R, et al. New-Onset Atrial Fibrillation After Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis. JACC Cardiovasc Interv 2022;15(6):603–13.

131. Bogyi M, Schernthaner RE, Loewe C, et al. Subclinical Leaflet Thrombosis After Transcatheter Aortic Valve Replacement: A Meta-Analysis. JACC Cardiovasc Interv 2021;14(24):2643–56.

132. Rodés-Cabau J, Masson J-B, Welsh RC, et al. Aspirin Versus Aspirin Plus Clopidogrel as Antithrombotic Treatment Following Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve: The ARTE (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation) Randomized Clinical Trial. JACC Cardiovasc Interv 2017;10(13):1357–65.

133. Brouwer J, Nijenhuis VJ, Delewi R, et al. Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation. N Engl J Med 2020;383(15):1447–57.

134. Dangas GD, Tijssen JGP, Wöhrle J, et al. A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement. N Engl J Med 2020;382(2):120–9.

135. Collet JP, Van Belle E, Thiele H, et al. Apixaban vs. standard of care after transcatheter aortic valve implantation: the ATLANTIS trial. Eur Heart J 2022;43(29):2783–97.

136. Guedeney P, Roule V, Mesnier J, et al. Antithrombotic therapy and cardiovascular outcomes after transcatheter aortic valve implantation in patients without indications for chronic oral anticoagulation: a systematic review and network meta-analysis of randomized controlled trials. Eur Heart J Cardiovasc Pharmacother 2023;9(3):251–61.

137. Jochheim D, Barbanti M, Capretti G, et al. Oral Anticoagulant Type and Outcomes After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv 2019;12(16):1566–76.

138. Van Mieghem NM, Unverdorben M, Hengstenberg C, et al. Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR. N Engl J Med 2021;385(23):2150–60.

139. Tanawuttiwat T, Stebbins A, Marquis-Gravel G, Vemulapalli S, Kosinski AS, Cheng A. Use of Direct Oral Anticoagulant and Outcomes in Patients With Atrial Fibrillation after Transcatheter Aortic Valve Replacement: Insights From the STS/ACC TVT Registry. J Am Heart Assoc 2022;11(1):e023561.

140. Didier R, Lhermusier T, Auffret V, et al. TAVR Patients Requiring Anticoagulation: Direct Oral Anticoagulant or Vitamin K Antagonist? JACC CardiovascInterv 2021;14(15):1704–13.

141. Alaour B, Ferrari E, Heg D, et al. Non-Vitamin K Antagonist Versus Vitamin K Antagonist Oral Anticoagulant Agents After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv 2024;17(3):405–18.

142. Wang L, Sang W, Jian Y, et al. Post-TAVR patients with atrial fibrillation: are NOACs better than VKAs?-A meta-analysis. Front Cardiovasc Med 2023;10:1175215.

143. Joosten LPT, van Doorn S, van de Ven PM, et al. Safety of Switching From a Vitamin K Antagonist to a Non-Vitamin K Antagonist Oral Anticoagulant in Frail Older Patients With Atrial Fibrillation: Results of the FRAIL-AF Randomized Controlled Trial. Circulation 2024;149(4):279–89.

144. Nijenhuis VJ, Brouwer J, Delewi R, et al. Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation. N Engl J Med 2020;382(18):1696–707.

145. Sherwood MW, Gupta A, Vemulapalli S, et al. Variation in Antithrombotic Therapy and Clinical Outcomes in Patients With Preexisting Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. CircCardiovascInterv 2021;14(4):e009963.

146. Moreno R, Souza J, Smolnik R, et al. Outcomes after TAVI in patients with atrial fibrillation and a history of recent PCI: Results from the ENVISAGE-TAVI AF trial. Clin Res Cardiol [Internet] 2024;Available from: http://dx.doi.org/10.1007/s00392-024-02379-5

147. Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2024;149(1):e1–156.

148. Virani SS, Newby LK, Arnold SV, et al. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation 2023;148(9):e9–119.

149. Byrne RA, Rossello X, Coughlan JJ, et al. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J 2023;44(38):3720–826.

150. Imaeda S, Inohara T, Yoshijima N, et al. Natural History of Leaflet Thrombosis After Transcatheter Aortic Valve Replacement: A 5-Year Follow-Up Study. J Am Heart Assoc 2022;11(23):e026334.

151. Koren O, Patel V, Chakravarty T, et al. Leaflet thrombosis in transcatheter aortic valve intervention: mechanisms, prevention, and treatment options. Front Cardiovasc Med 2023;10:1249604.

152. Goel SS, Ige M, Tuzcu EM, et al. Severe aortic stenosis and coronary artery disease--implications for management in the transcatheter aortic valve replacement era: a comprehensive review. J Am Coll Cardiol 2013;62(1):1–10.

153. Lateef N, Khan MS, Deo SV, et al. Meta-Analysis Comparing Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation With Versus Without Percutaneous Coronary Intervention. Am J Cardiol 2019;124(11):1757–64.

154. Aarts HM, van Hemert ND, Meijs TA, et al. Percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis. Neth Heart J 2023;31(12):489–99.

155. Patterson T, Clayton T, Dodd M, et al. ACTIVATION (PercutAneous Coronary inTerventionprIor to transcatheter aortic VAlveimplantaTION): A Randomized Clinical Trial. JACC Cardiovasc Interv 2021;14(18):1965–74.

156. Lønborg J, Jabbari R, Sabbah M, et al. PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med [Internet] 2024;Available from: http://dx.doi.org/10.1056/NEJMoa2401513

157. Faroux L, Munoz-Garcia E, Serra V, et al. Acute Coronary Syndrome Following Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv 2020;13(2):e008620.

158. Tarantini G, Tang G, Nai Fovino L, et al. Management of coronary artery disease in patients undergoing transcatheter aortic valve implantation. A clinical consensus statement from the European Association of Percutaneous Cardiovascular Interventions in collaboration with the ESC Working Group on Cardiovascular Surgery. EuroIntervention 2023;19(1):37–52.

159. Ahn J-M, Kang D-Y, Lee PH, et al. Preventive PCI or medical therapy alone for vulnerable atherosclerotic coronary plaque: Rationale and design of the randomized, controlled PREVENT trial. Am Heart J 2023;264:83–96.

160. Barbanti M, Costa G, Picci A, et al. Coronary Cannulation After Transcatheter Aortic Valve Replacement: The RE-ACCESS Study. JACC CardiovascInterv 2020;13(21):2542–55.

161. Tarantini G, Nai Fovino L, Scotti A, et al. Coronary Access After Transcatheter Aortic Valve Replacement With Commissural Alignment: The ALIGN-ACCESS Study. CircCardiovascInterv 2022;15(2):e011045.

162. Akodad M, Lounes Y, Meier D, et al. Transcatheter heart valve commissural alignment: an updated review. Front Cardiovasc Med 2023;10:1154556.

163. Yudi MB, Sharma SK, Tang GHL, Kini A. Coronary Angiography and Percutaneous Coronary Intervention After Transcatheter Aortic Valve Replacement. J AmCollCardiol 2018;71(12):1360–78.

164. Zivelonghi C, Pesarini G, Scarsini R, et al. Coronary Catheterization and Percutaneous Interventions After Transcatheter Aortic Valve Implantation. Am J Cardiol 2017;120(4):625–31.

165. Lancellotti P, Pibarot P, Chambers J, et al. Recommendations for the imaging assessment of prosthetic heart valves: a report from the European Association of Cardiovascular Imaging endorsed by the Chinese Society of Echocardiography, the Inter-American Society of Echocardiography, and the Brazilian Department of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging 2016;17(6):589–90.

166. Capodanno D, Petronio AS, Prendergast B, et al. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg 2017;52(3):408–17.

167. Michelena HI, Della Corte A, Prakash SK, Milewicz DM, Evangelista A, Enriquez-Sarano M. Bicuspid aortic valve aortopathy in adults: Incidence, etiology, and clinical significance. Int J Cardiol2015;201:400–7.

168. Michelena HI, Desjardins VA, Avierinos J-F, et al. Natural history of asymptomatic patients with normally functioning or minimally dysfunctional bicuspid aortic valve in the community. Circulation 2008;117(21):2776–84.

169. van Rosendael PJ, Kamperidis V, Kong WKF, et al. Comparison of Quantity of Calcific Deposits by Multidetector Computed Tomography in the Aortic Valve and Coronary Arteries. Am J Cardiol 2016;118(10):1533–8.

170. Kim W-K, Renker M, Rolf A, et al. Annular versus supra-annular sizing for TAVI in bicuspid aortic valve stenosis. EuroIntervention 2019;15(3):e231–8.

171. Fedak PWM, Verma S, David TE, Leask RL, Weisel RD, Butany J. Clinical and pathophysiological implications of a bicuspid aortic valve. Circulation 2002;106(8):900–4.

172. Bauer T, Linke A, Sievert H, et al. Comparison of the effectiveness of transcatheter aortic valve implantation in patients with stenotic bicuspid versus tricuspid aortic valves (from the German TAVI Registry). Am J Cardiol 2014;113(3):518–21.

173. Forrest JK, Kaple RK, Ramlawi B, et al. Transcatheter Aortic Valve Replacement in Bicuspid Versus Tricuspid Aortic Valves From the STS/ACC TVT Registry. JACC Cardiovasc Interv 2020;13(15):1749–59.

174. Makkar RR, Yoon S-H, Leon MB, et al. Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke. JAMA 2019;321(22):2193–202.

175. Boiago M, Bellamoli M, De Biase C, et al. Three-year clinical outcomes after transcatheter aortic valve implantation in patients with bicuspid aortic disease: Comparison between self-expanding and balloon-expandable valves. Catheter Cardiovasc Interv 2024;103(6):1004–14.

176. Singh JP, Evans JC, Levy D, et al. Prevalence and clinical determinants of mitral, tricuspid, and aortic regurgitation (the Framingham Heart Study). Am J Cardiol 1999;83(6):897–902.

177. Seiffert M, Bader R, Kappert U, et al. Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation. JACC Cardiovasc Interv 2014;7(10):1168–74.

178. Stachon P, Kaier K, Heidt T, et al. Nationwide outcomes of aortic valve replacement for pure aortic regurgitation in Germany 2008-2015. CatheterCardiovascInterv 2020;95(4):810–6.

179. Poletti E, De Backer O, Scotti A, et al. Transcatheter Aortic Valve Replacement for Pure Native Aortic Valve Regurgitation: The PANTHEON International Project. JACC Cardiovasc Interv 2023;16(16):1974–85.

180. Yoon S-H, Schmidt T, Bleiziffer S, et al. Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation. J Am Coll Cardiol 2017;70(22):2752–63.

181. Sanchez-Luna JP, Martín P, Dager AE, et al. Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation. EuroIntervention 2023;19(7):580–8.

182. Takagi H, Hari Y, Kawai N, Ando T, ALICE (All-Literature Investigation of Cardiovascular Evidence) Group. Meta-Analysis and Meta-Regression of Transcatheter Aortic Valve Implantation for Pure Native Aortic Regurgitation. Heart Lung Circ 2020;29(5):729–41.

183. Garcia S, Ye J, Webb J, et al. Transcatheter Treatment of Native Aortic Valve Regurgitation: The North American Experience With a Novel Device. JACC CardiovascInterv 2023;16(16):1953–60.

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2024 Update of the Consensus on Percutaneous Aortic Valve Implantation of the Argentinian College of Interventional Cardiologists

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Revista Argentina de Cardioangiología intervencionista, Volumen Año 2024 4

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