Early experience in Argentina and Latin America with aortic valve transcatheter implantation with the VitaFlow self-expanding transcatheter heart valve
Carlos Giuliani, Carlos Fernández-Pereira, Verónica González, Gustavo Andersen, Marcelo Menéndez, Sebastián Peralta, José Lazarte, Alejandro Tetamanzi, Diego Grinfeld, Juan Pablo Debrahi, Gustavo Samaja, Juan , , , Mieres2,, Diego Ascarrunz-Cattoretti, Carlos Haiek, Matías Sztejfman
Revista Argentina de Cardioangiología Intervencionista 2022;(3): 0130-0135 | Doi: 10.30567/RACI/20223/0130-0135
Objectives. Transcatheter aortic valve implantation (TAVI) has become a therapeutic alternative for patients with severe symptomatic aortic stenosis (AS). VitaFlow Liberty (VFL) (Microport Inc, Shanghai, China) is a new generation of TAVI devices with a novel motorized delivery system (DS) for proper valve deployment. The objective of this study is to share the first Latin American experience with this new self-expanding valve (SEV).
Methods. We analyzed a local TAVI registry database from august 2021 through July 2022. Data from clinical, echocardiographic, procedural, and 30-day outcomes were collected. A total of 28 consecutive patients with severe symptomatic AS treated with TAVI with the VitaFlow system were included during the initial proctorized multicenter experience using the optimized cusp overlapping TAVI technique. The VFL is a SEV with an inner and outer sealing PET skirt. The DS has a unique feature so the valve can be positioned or recaptured accurately with the motorized handle.
Results. The mean age was 79.5 ± 8.2 y/o; 44% were men, 44% of the patients had NYHA functional class ≥III, and the median EuroSCORE II 5 and STS scores were 5.3 (4.3-6.7) and 5.5 (4-6.7), respectively. A total of 100% of the patients were treated via transfemoral access. The mean size of the THV was 27.1 mm ± 2.3 mm, the rates of pre- and post-dilatation were 96% and 18%, respectively, and 32% of the valves had to be repositioned. Device success was achieved in all patients. No deaths were reported, and the rate of conversions to surgery, embolization or major vascular complications, and major bleeding was 4% at 30 days. (1) The rate of new-onset LBBB was 14% while PPM were implanted in 3.5% of the cases.(1) VitaFlow implantation resulted in a significantly reduced mean gradient (46.5 ± 14.8 down to 6.8 ± 3.0 mmHg, P< .001), and increased effective-orifice area (0.7 ± 0.2 cm2 up to 2.1 ± 0.36 cm2; P = .001) at hospital discharge (HD). The rates of PVL > moderate, none/trace, and mild were 0%, 75% (21), and 25% (7). HD occurred after a mean of 2.1 ± 0.7 days, and all patients were alive and with NYHA functional class I-II at 30-day follow-up.
Conclusion. The early limited experience with the VitaFlow Liberty device provides a very good safety and efficacy profile as seen in the post-valve area, lack of AR > grade 2, lack of major complications, and an extremely low incidence of PPM implantation.
Palabras clave: TAVI, self-expanding TAVI, Aortic stenosis, VitaFlow.
Antecedentes y objetivo. El reemplazo transcatéter de la válvula aórtica (TAVR) se ha convertido en una alternativa terapéutica para pacientes con estenosis aórtica (EA) sintomática grave. VitaFlow Liberty (VFL) (Microport Inc) es una nueva generación de dispositivos TAVR con un novedoso sistema de entrega motorizado (DS) que ayuda a un despliegue preciso de la válvula. El objetivo de este informe es compartir la primera experiencia latinoamericana con esta nueva válvula autoexpandible (SEV).
Métodos. Analizamos una base de datos de registro TAVR local desde agosto de 2021 hasta Julio de 2022. Se recogieron datos clínicos, ecocardiográficos, de procedimientos y de resultados a 30 días. Veintiocho pacientes consecutivos con EA sintomática grave sometidos a TAVR con VitaFlow se incluyeron durante la experiencia multicéntrica inicial supervisada, utilizando la técnica optimizada y de superposición de cúspide. VFL es una válvula SE con una pollera de sellado interna y externa de PET. El DS tiene una característica única que permite posicionar o recapturar el dispositivo con precisión debido al mango motorizado.
Resultados. La edad media fue de 79,5 ± 8,2 años, el 44% eran hombres, la tasa de NYHA ≥III fue 44%, con una mediana de EuroSCORE II de 5,3 (4,3-6,7) y de puntuación STS de 5,5 puntos (4-6,7); en el 100% se utilizó el acceso transfemoral. El tamaño medio del THV fue de 27,1 ± 2,3 mm, la predilatación de 96% y la posdilatación de 18%, y se necesitó reposición en el 32%. El éxito del dispositivo se logró en todos los pacientes. A los 30 días, no hubo muertes, conversiones a cirugía, embolización o complicaciones vasculares mayores, el sangrado mayor fue del 3,5% (1). La LBBB de nueva aparición fue de 16% y la tasa de PPM fue requerida en 3,5% (1). La implantación de VitaFlow resultó en una reducción significativa en el gradiente medio (46,5 ± 14,8 a 6,8 ± 3,0 mmHg, p<0,001) y un aumento en el área de orificio efectivo (0,7 ± 0,2 a 2,1 ± 0,36 cm2, p=0,001) al alta hospitalaria (HD). La PVL>2 fue de 0%, ninguna/trivial en 75% (21) y leve 25% (7). La mrdia de la estadía hospitalaria fue de 2,1 ± 0,7 días, y todos los pacientes estuvieron en NYHAI-II en el seguimiento a los 30 días.
Conclusión. La experiencia inicial con VitaFlow Liberty mostró un muy buen perfil de seguridad dado por el área valvular obtenida posimplante, la ausencia de regurgitación aórtica >2 y la muy baja incidencia de marcapasos permanente posimplante.
Keywords: TAVI, TAVI autoexpandible, estenosis aórtica, VitaFlow.
Los autores declaran no poseer conflictos de intereses.
Fuente de información Colegio Argentino de Cardioangiólogos Intervencionistas. Para solicitudes de reimpresión a Revista Argentina de Cardioangiología intervencionista hacer click aquí.
Recibido 2022-08-20 | Aceptado 2022-09-05 | Publicado
Esta obra está bajo una Licencia Creative Commons Atribución-NoComercial-SinDerivar 4.0 Internacional.
Aortic stenosis (AS) is the most common valvular heart disease. Calcium deposit related degenerative etiology is the most prevalent of all. AS related symptom onset is associated with a lower life expectancy. One out of every 8 people over 75 years will develop moderate or severe aortic valvular stenosis in their lifetime.1 With the ageing of the population this tendency has been growing and now we find elderly patients who are frailer and of a higher surgical risk.2
Transcatheter aortic valve implantation (TAVI) is a new therapeutic much less invasive alternative that prevents the use of extracorporeal circulation and the occurrence of cardiac arrest.
Since it first appeared back in 2002,3 TAVI has revolutionized the management of severe aortic stenosis and become the standard of choice for inoperable or high-surgical risk patients. As a matter of fact, it is the treatment preferred by many elderly intermediate-and-low risk patients.4,5 Over time, several state-of-the-art transcatheter heart valves have been developed—both balloon-expandable and self-expanding—with characteristics aimed at minimizing complications and/or the associated procedural limitations to improve clinical outcomes and expand its indications.6
This is our early experience with the VitaFlow and VitaFlow Liberty valves (Microport Inc, Shanghai, China) in Argentina and Latin America.
Material and methods
A total of 28 consecutive patients with severe aortic valve disease and an indication for TAVI were treated between August 2021 and July 2022. Cases were performed by the same proctoring heart team in Argentina and/or with great experience performing TAVIs. The study group inclusion criteria were the presence of symptomatic severe aortic stenosis and the heart team decision to go with the transcatheter procedure as the best therapeutic option available.
All the group patients were treated with the VitaFlow and VitaFlow Liberty devices. The VitaFlow is a self-expanding valve that consists of a nitinol stent on which 3 bovine pericardial leaflets with anti-calcification properties are mounted plus a PET skirt for better sealing of the landing zone (Figure 1).
There are 4 different sizes available: 21 mm, 24 mm, 27 mm, and 30 mm to cover an aortic valve annulus perimeter between 17 mm and 29 mm, and an area between 229.9 mm2 and 660.2 mm2.
These are the main characteristics of the VitaFlow valve:
VitaFlow is a low-profile 16-Fr-17-Fr easy-to-maneuver, highly flexible, motorized delivery system that can be bent 360 degrees. In addition, it is very precise during valve deployment and comes with a manual back-up system (Figure 2).
All patients were treated with an echocardiogram, coronary angiography, CCTA, and analyzed using Horos software.
Sedoanalgesia was used in 100% of the patients based on our routine protocol. Access route was transfemoral via percutaneous or surgical approach. Heparin was administered to achieve an ACT > 300 seconds. Afterwards, a pigtail catheter was introduced via right radial or contralateral femoral access with respect to the valve access route until it reached the non-coronary sinus. Rapid pacing wires were placed in patients except for those with right bundle branch block (RBBB).
An aortogram was performed through the pigtail catheter in the right caudal oblique position to verify the early work view using the cusp overlapping technique. Afterwards, the femoral artery was punctured, and a 7-Fr introducer-sheath was inserted. A curved guidewire was then passed towards the aortic root on which an AL 1 or JR catheter was mounted. This curved guidewire was exchanged for a flexible tip straight guidewire, and the native aortic valve was crossed. Once the guidewire has been passed, the catheter is advanced until it reaches the inside of the left ventricle. Afterwards, the straight guidewire was exchanged for a Safari™ Extra-Small support guidewire (Boston Scientific, Marlborough, MA, United Sates) until it was properly placed into the left ventricular chamber. Then, the 7-Fr introducer sheath was removed, and through the support guidewire a different 14-Fr introducer sheath or the valve delivery system was advanced.
Afterwards, a balloon valvuloplasty was performed in cases of severe aortic stenosis for a short period of over-pacing. The size of the balloon picked matched the minimum diameter of the aortic annulus as measured on the CCTA. No valvuloplasty was performed in cases of poorly calcified valves.
Afterwards, the delivery system mounted on the Safari™ support guidewire was advanced under radiological control until it was placed in the landing zone as confirmed by the angiography. Valve was slowly deployed, and implantation depth was corrected through small variations of the cusp overlapping view. Valve was deployed up to 75% of its full capacity under rapid pacing (moment when the valve opens and shuts) to check the left oblique position once again, and slowly complete the deployment. When in doubt, the valve was retrieved and repositioned uneventfully. After implantation, the delivery system was removed. The final outcome was confirmed on the angiography and, if necessary, on the transthoracic echocardiogram.
In cases with unacceptable residual paravalvular leak, postdilatation was performed with a smaller balloon compared to the maximum aortic valve annulus diameter.
After successful implantation, all guidewires and catheters were removed. The introducer sheath was removed too, and the femoral artery was percutaneously or surgically closed.
Afterwards, patients were referred to the coronary care unit (CCU) and remained there under 24-hour monitoring.
The in-hospital and 30-day mortality rates were collected. Intra- and postoperative complications were reported based on the consensus definitions established in the guidelines published by the Valve Academic Research Consortium, and the Valve Academic Research Consortium-2.7 Demographic and clinical variables, and echocardiographic data were collected too. In addition, hospitalization stay (in days) and complications at discharge were collected as well. Thirty-day clinical and echocardiographic follow-up was conducted.
The VitaFlow (13; 47%) and VitaFlow Liberty (15; 53%) transcatheter heart valves were implanted in all the patients. Mean age was 79.5 ± 8.2 years and 44% were men. The median risk scores obtained in the EuroSCORE II and STS scores were 5.3 (4.3-6.7) and 5.5 (4-6.7), respectively. Valve-in-valve procedure was performed in 1 case only (Table 1).
Only 1 valve was implanted in each patient (100% implantation success rate).
Access route was transfemoral in 28 patients (100%). In 50% of the patients with percutaneous access 2 Abbott’s Perclose ProGlide™ vascular closure devices were used.
Balloon valvuloplasty was performed in 26 patients (93%). After implantation, 5 patients (20%) required balloon postdilatation.
No in-hospital or overall deaths were reported at the early 30-day follow-up.
In all the cases, the implantation system navigability was good even in anatomies with tortuous iliofemoral axes or more horizontal aortas. In cases of severe aortic calcification including the aortic arch (as seen on Figures 3 A and B) 2 support guidewires were used: the aforementioned Safari plus a high-support Lunderquist guidewire (Cook Cop, IN, United States). A pigtail catheter was advanced for better movement of the valve through the aortic arch avoiding difficult maneuvers while crossing the arch or the snare technique that is much more complicated. The 2 support guidewires helped cross this difficult aortic arch and successfully implant the valve as seen on Figures 3 C, D, E, and F.
Implantation was successful on the 1st attempt in 18 cases (64%) with need for partial recapture in 9 (32%) and full recapture in 7 (28%). Both the valve and the delivery system were removed completely uneventfully (Table 2).
After successful valve implantation, residual paravalvular leak was considered non-existent/trivial and mild in 78.6% (22) and 21.4%, respectively. (6) No moderate of severe paravalvular leak was reported. The mean transvalvular gradient was 6.86 ± 3.2 mmHg in the native valves with a median effective orifice area of 2.04 mmHg (1.8-2.2) (Figure 4).
Definitive pacemaker implantation was required in 1 patient (3.5%) due to the presence of BAV type 3 (table 3).
TAVI has become an unquestionable therapeutic reality that has gained popularity to treat lower-risk patients. In our early experience reported here, the clinical success rate—both immediate and at 30-days—was 100%. The valve proved effective and safe to treat this population group of mostly moderate-to-high risk patients for conventional surgery.
The lack of major intraoperative complications and at 30 days can be explained by the fact that the operator group is experienced performing this type of transcatheter implantation procedures. However, we believe that some questions regarding the valve specific design should be mentioned.
The low rate of permanent pacemaker implantation at 30-days was only 3.5%. In this series, this rate is lower than the one recently reported by us regarding self-expanding valves (12.5% and 9.4%).8,9 Also, this rate of 3.5% is similar to the one reported in the latest designs for balloon-expandable valves in low-and-intermediate risk patients.10-17
The rate of permanent pacemaker implantation is a crucial element when indicating TAVI for young and low or intermediate risk patients. Although permanent pacemaker implantation has not been associated with a higher mortality rate in the first studies published, it is obvious that the high numbers reported jeopardize the quality of life of young patients treated with TAVI.15
The valve design with its electronic delivery device makes it extraordinarily precise and is probably a pivotal factor that explains the low rate of permanent pacemaker implantation reported and the lack of paravalvular leak > 2 in this series, which is inidicative of a highly competitive valve compared to other balloon-expandable valves as shown on Figure 5.10
Also, we think that other technical factors involved like implantation using the cusp overlapping technique were important. There is no doubt that these factors were very useful and lowered the rate of permanent pacemaker implantation after TAVI.
The experience of the operator group is also important since all procedures were performed via transfemoral access even to treat hostile and highly calcified aortic territories as it was the case with 2 patients from this series.
The study limitations have to do with its small sample size mainly, the short follow-up period involved, and the fact that procedures were performed by 2 operators with great expertise performing TAVI procedures. However, we don’t know if these numbers will be the same in larger samples with more patients or what evolution will this device have in the mid- and long-term.
Our early experience with VitaFlow and VitaFlow Liberty demonstrated that this valve safety profile is good. Also, that the 30-day hemodynamic status was excellent as the low rate of permanent pacemaker implantation and 30-day paravalvular leak > 2 proved.
Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enríquez-Sarano E. Burden of valvular heart diseases: A population-based study. Lancet 2006;368:1005-11.
Iung B, Baron G, Tornos P, Gohlke-Bärwolf C, Burchart EG, Vahaninan A. Valvular heart disease in the community: A European experience. Curr Probl Cardiol 2007;32:609-61. http://dx.doi.org/10.1016/j.cpcardiol.2007.07.002.
Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: First human case description. Circulation 2002;106:3006-8. http://dx.doi.org/10.1161/01.cir.0000047200.36165.b8.
Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J 2017;38:2739-91.
Cahill TJ, Chen M, Hayashida K, et al. Transcatheter aortic valve implantation: Current status and future perspectives. Eur Heart J 2018;39:2625-34.
Tchetche D, Van Mieghem NM. New-generation TAVI devices: Description and specifications. EuroIntervention 2014;10 Suppl U:U90-U100.
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Sztejfman M, Giuliani CM, Peralta S, Zaidel EJ, Sztejfman LC, Bettinotti MO. Impacto de la técnica de Cusp-Overlap en el requerimiento de marcapasos luego de un implante valvular aórtico percutáneo. Rev Argent Cardiol. [online]. 2021;89(2):140-144.
Fernández-Pereira C, Mieres J, Pavlovsky H, et al, Experiencia con el implante valvular aórtico con la válvula autoexpandible Portico: resultados hospitalarios, a 30 días y en el seguimiento alejado de una serie consecutiva de pacientes. Revista Argentina de Cardioangiología Intervencionista 2021;(04):0213-0217 | Doi: 10.30567/RACI/202104/0213-021.
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Waksman R, Rogers T, Torguson R, et al. Transcatheter aortic valve replacement in low-risk patients with symptomatic severe aortic stenosis. J Am Coll Cardiol 2018;72:2095-105. doi: 10.1016/j.jacc.2018.08.1033.
Sondergaard L, Costa G. Transcatheter aortic valve replacement in patients with aortic stenosis and low surgical risk. J Am Coll Cardiol 2019;74:1541-2. doi: 10.1016/j.jacc.2019.07.067.
Reardon M, Van Mieghem N, Popma J, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med 2017;376:1321-31.
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Kolte D, Vlahakes GJ, Palacios IF, et al. Transcatheter versus surgical aortic valve replacement in low-risk patients. J Am Coll Cardiol 2019;74:1532-40. doi: 10.1016/j. jacc.2019.06.076.
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Early experience in Argentina and Latin America with aortic valve transcatheter implantation with the VitaFlow self-expanding transcatheter heart valve
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