Tabla 1.

Figura 1. In the planning we can observe the main features that we use for the implant, such as: the...

Figura 2. In the sequence can be observed how an attempt was made to cross the aortic valve with dif...

Figura 3. this figure the changes implemented by the new NavitorTM device can be appreciated regardi...

Figura 4. FlexNav™ Delivery System (Abbott, Chicago, Illinois, United States), comes in 14 Fr and ...

INTRODUCTION

Nowadays, innovation is a constant in our specialty, and certainly it is for the patients’ benefit, but it implies a great challenge of daily updating for the interventional cardiologist. All the main companies try to improve the performance of their devices constantly. In this particular case we present a patient where there was an extreme difficulty to go into the ventricle, we believe it was due to a critical stenosis of the aortic valve, the eccentricity of this hole y its acute calcification. Concurrently, we tried implanting the first NavitorTM valve with its new delivery system, the FlexNavTM Delivery System (Abbott, Chicago, Illinois, United States), in our Service and in the region, as we have great experience in its predecessor PórticoTM (Abbott, Chicago, Illinois, United States)1,2. At the end of an extremely long period of fluoroscopies compared to previous implants, we could finish the procedure without complications.

The purpose of this presentation is the report of this case and a review of the bibliography on this topic.

CLINICAL CASE

An 81-year-old male patient with critical aortic stenosis, with an area of 0.4 cm2, symptomatic due to cardiac insufficiency. In Figure 1 we observe the planning sheet that we usually develop for all the TAVI cases in our Service before the implantation takes place, where we can observe the acute calcification of the aortic valve, the birth of coronaries with accurate height and precise accesses for the femoral route. The percutaneous closure has been panned with Perclose ProGlideTM (Abbott, Chicago, Illinois, United States). After putting arterial and venous cannulas in the left groin, and introducer 12 Fr arterial through the right femoral prior placement of percutaneous closures, with the habitual technique of a 6 Fr Amplatz diagnostic catheter (Terumo, Shibuya City, Tokyo, Japan) curve 1 and a 0.0035” hydrophilic wire short straight from Terumo, after right and left oblique projections and position of work and a prudential time, we rotate catheters, first to a multipurpose, then to one of right coronary, after that to a mammary catheter, we returned to the Amplatz catheter and finally we decided to use a Terumo pigtail catheter (Figure 2), and after 75 minutes of fluoroscopy we could go through the valve. We consider this as the first time, and in the second time, 19 minutes went by until we reached the implant of a valve 27 of NavitorTM and its FlexNav delivery system (Table 1). Afterwards, no gradients were present in angiographic and echocardiogram controls, but there was a minimum aortic reflux.

DISCUSSION

Sometimes the improvisation is the art of sorting out complex situations that we face every day at our interventional tables, like in this case report, where to find the left ventricle was extremely hard; at some moment other alternatives or rescheduling to evaluate was raised. However, we could finally cross the valve with a catheter which is atypical for this procedure, a Terumo pigtail catheter, although Wolfgang Schoels et al. submitted a paper where patients undergoing severe aortic stenosis who had an area smaller than 1 cm2 or 0.6 cm2 indexed, who had received a TAVI tested a protocol where doctors tried to go through the valve with a pigtail catheter inserted at 3 or 4 cm over the valve rotating the catheter in anterior position in right anterior oblique at 30 degrees with a J standard wire for 5 minutes, and they managed to go into it in an 86% and the rest of the patients could go into it with AL1 and AL2.3

In a study of multiple images to perform the crossover of the aortic valve it was suggested that operators could have two echocardiographic variables, two variables of computed tomography (CT) and two fluoroscopic variables that seem to improve our understanding of this procedure. The echocardiographic variables include speed; for example, the higher the speed is, the longer the total time of the crossing of the aortic valve (TTCV) will be. CT variables are the perimeter of the valve and the angle of the aortic root, so that a smaller perimeter was related to a longer TTCV and the angle of the aortic root provided the base for the categorization of the two fluoroscopic variables, CTC (catheter to catheter from AL-1 to pigtail) and CTW (catheter by wire) which were used to characterize a successful access. The aortic valve was systematically crossed with a pigtail catheter stationed in the non-coronary sinus, an AL-1 catheter over the AV and a straight guide to cross, in a left anterior oblique view of 20o, while the operator adjusted catheter to catheter (CTC: AL-1 to flexible wire) and from catheter to catheter (CTW: flexible wire to wire) with each failed passing4.

In patients with extreme difficulty the venous valvuloplasty could be raised, through the auricular septum as it is performed for the mitral valvuloplasty, as it was described by Ted Felman5, remembering that the first TAVI by Cribier et al.6 was implanted by the transseptal route and now it is reserved for patients who do not present another access route. Another access route that nowadays is used as an exception is the transapical one, which was a boom and then it has been declining to minimal values so far; we treat a great variety of patients by this route and crossing the valve, although it was critical from the ventricle, it became very easy as we even went through it with a J standard guide (Boston Scientific, Massachusetts, USA)7-9.

Every innovation needs other instruments to be able to be implemented and it is just like that the images have shown a qualitative jump in the last years, adding to this arsenal the large pre-procedure evaluation and in the treatment by 3D type intracardiac images which could be useful for the different phases of the percutaneous aortic valve implantation, from passing the valve up to its implant. A subspecialty has also been created turning into specialists in structural images, due to the fact that they have to be specialists in 2D echocardiography, transesophageal echocardiography, multi-slice tomography and lately intracardiac ultrasound with 3D images, which require training for pre-procedure images, intra-procedure images and finally in the follow-up. The artificial intelligence is also present by building 3D imaging pre-procedure patterns10-13.

Finally, as a team which is always at the forefront of the percutaneous intervention in all the fields, we implanted the first NavitorTM valve (Figure 3) with FlexNavTM (Figure 4)14,15, an extremely more stable release system, with a renewed low crossability profile, which received its approval in the European market in May 2021, and in January of this year it was approved by the American Food and Drug Administration (FDA)16. NavitorTM device is implanted with a delivery system called FlexNavTM, which has a very low profile design used to adapt different patients´ anatomies and small vessels, and an accurate, predictive and stable valve placement17. In Table 1 the times of our procedures are observed compared to the case report and in the patients who received a PórticoTM and NavitorTM device. In the first trials a low rate of paravalvular leak, a low rate of pacemaker and mortality18 are shown in high risk patients. In the PCR meeting of the year 2022, a trial of 120 patients with NavitorTM (average age 83.5 years old; 58.3% women) was submitted, performed in 19 centers of Europe, Australia and United States of America which had a high load of comorbidity, more than a half (56.7%) had symptoms class III or IV of NYHA at the beginning of the study and the average scoring of STS was 4%. 83.3% had at least a fragility factor. The success of the procedure was 97.5%, without deaths nor surgical conversions during TAVI. Mortality due to all the causes during the year was 4.2%. Beyond 30 days, there were no additional cerebrovascular accidents (one occurred on day 4 after TAVI) and in the 16.8% of the population a pacemaker was implanted at a year (out of these 18 patients, 13 already had abnormalities of preexisting conduction). After 1 year, the average gradient had decreased to 7.5 mm Hg and the effective area of the hole had increased to 1.9 cm2. The paravalvular leak was null or minimal in the 70.2% of the patients, mild in the 28.8% and moderate in only one patient (1.0%); no serious paravalvular leak was reported. Almost all the patients (97.2%) had symptoms of NYHA class I or II at a year19.

CONCLUSION

Innovation is under constant development and it does not stop. Today we have presented the first NavitorTM implant with FlexNavTM in Argentina, with the addition that it was really challenging to cross the aortic valve and it could be achieved with a pigtail catheter.

1. 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;12(04):0213-0217.

2. Sondergaard L, Walton AS, Worthley SG, et al. Thirty-day and one-year outcomes of the Navitor transcatheter heart valve in patients with aortic stenosis: the prospective, multicentre, global PORTICO NG Study. EuroIntervention 2023 Mar 9:EIJ-D-22-01108.

3. Schoels W, Mahmoud MS, Kullmer M, Dia M. A safe and simple technique for crossing stenotic aortic valves. Clin Res Cardiol 2021 Mar;110(3):377-81.

4. Roback J, Ammar Z, Shah S, et al. From Modern Imaging and Catheter Wire Measurements in Patients Undergoing Transcatheter Aortic Valve Replacement. J Invasive Cardiol 2020 Jul;32(7):262-8.

5. Feldman T. Transseptal antegrade access for aortic valvuloplasty. Catheter Cardiovasc Interv. 2000 Aug;50(4):492-4. doi: 10.1002/1522-726x(200008)50:4<492::aid-ccd26>3.0.co;2-s.

6. 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(24):3006-8.

7. Mieres J, Menéndez M, Fernández Pereira C, et al. Acceso transapical percutáneo de válvula aórtica con prótesis de JenaValve: experiencia inicial del Departamento de Cardiología del Sanatorio Otamendi. Revista Argentina de Cardioangiología Intervencionista 2014;5(04):0268-0274.

8. Mieres J, Menéndez M, Fernández-Pereira C, Rubio M, Rodríguez AE. Transapical Implantation of a 2nd-Generation JenaValve Device in Patient with Extremely High Surgical Risk. Case Rep Cardiol 2015;2015:458151.

9. Sohal S, Mehta H, Kurpad K, et al. Declining Trend of Transapical Access for Transcatheter Aortic Valve Replacement in Patients with Aortic Stenosis. J Interv Cardiol 2022 Sep 19;2022:5688026.

10. Enriquez A, Saenz LC, Rosso R, et al. Use of Intracardiac Echocardiography in Interventional Cardiology: Working With the Anatomy Rather Than Fighting It. Circulation 2018 May 22;137(21):2278-94.

11. Faza NN, Özden Tok Ö, Hahn RT. Imaging in Structural Heart Disease: The Evolution of a New Subspecialty. JACC Case Rep 2019 Oct 2;1(3):440-5.

12. Agricola E, Ingallina G, Ancona F, et al. Evolution of interventional imaging in structural heart disease. Eur Heart J Suppl 2023 Apr 26;25(Suppl C):C189-C199.

13. Wang DD, Qian Z, Vukicevic M, et al. 3D Printing, Computational Modeling, and Artificial Intelligence for Structural Heart Disease. JACC Cardiovasc Imaging 2021 Jan;14(1):41-60.

14. Zaid S, Atkins MD, Kleiman NS, Reardon MJ, Tang GHL. What’s New with TAVR? An Update on Device Technology. Methodist DeBakey Cardiovasc J 2023 May 16;19(3):4-14.

15. Santangelo G, Ielasi A, Pellicano M, et al. An Update on New Generation Transcatheter Aortic Valves and Delivery Systems. J Clin Med 2022 Jan 19;11(3):499.

16. Abbott receives FDA approval for Navitor, a next generation TAVI system designed to treat aortic stenosis. Abbott. News release. January 17, 2023. Accessed January 19, 2023. https://abbott.mediaroom.com/2023-01-17-Abbott-Receives-FDA-Approval-for-Navitor-TM-,-a-Next-Generation-TAVI-System-Designed-to-Treat-Aortic-Stenosis.

17. Wong I, Bajoras V, Wang X, et al. Technical Considerations for Transcatheter Aortic Valve Replacement With the Navitor Transcatheter Heart Valve. JACC Cardiovasc Interv 2021 Oct 11;14(19):e259-e261.

18. Corcione N, Berni A, Ferraro P, et al. Transcatheter aortic valve implantation with the novel-generation Navitor device: Procedural and early outcomes. Catheter Cardiovasc Interv 2022 Jul;100(1):114-9.

19. Smith D. One-year outcomes from a next generation TAVI device with an active sealing cuff. Presented at: EuroPCR 2022. May 17, 2022. Paris, France.

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Cutting-edge innovation. First case of TAVI in the region with Navitor™ and its new delivery system the FlexNav™ Delivery System in a patient with extreme difficulty in crossing the critical, severely calcified and eccentric aortic valve

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