Guest Editor Series: 21 Years After First TAVI: Will the Pace of Innovations Continue for All Heart Valves?

In the newest entry into the CTSNet Guest Editor Series collection, “20 Years After First TAVI: Will the Pace of Innovations Continue for All Heart Valves?” Gry Dahle, MD, PhD presents a curated collection of videos on the history, current challenges, and future advances of transcatheter valve replacement. You can learn more about Dr. Dahle in her Featured Profile Interview.

This CTSNet Guest Editor Series features seven contributor videos from five transcatheter surgery specialists from around the world. The videos were released from March 27–31, 2023. For details regarding the content, the authors, and video lineup, please scroll to the bottom of this page.

Greetings CTSNet community members,

The advent of percutaneous balloon angioplasty in 1977 was the first major step to inspire the development of transcatheter structural heart interventions. 

Then, in 1986, Alain Cribier in Rouen, France performed the first in-man balloon aortic valvuloplasty (BAV) for calcific aortic stenosis (1). In 1992, Henning Rud Andersen carried out the first transcatheter implantation of an artificial aortic valve in pigs. However, the idea of implanting a balloon-expandable stented valve into diseased aortic valves in humans was met with much skepticism (2).

After many iterations and technical developments, on April 16, 2002, Cribier and Eltchaninoff performed the first in-man transcatheter aortic valve implantation (TAVI) (3). Over the following twenty years, there has been a huge evolution in imaging and procedural strategy, alternative access routes, valve development, and delivery systems. Today, the delivery systems have a low profile, and most procedures can be done transfemorally. Now, with the ease and good outcomes of the procedure, doctors are weighing the benefits and downsides for low-risk and younger patients, with the issue of durability and who lives longer—the patient or the valve (4).

For the mitral valve, the process has been slower. The first mitral intervention was performed in a human in 2003, when the MitraClip was implanted in Venezuela, and trials started in the United States. The technique is based on the edge-to-edge repair in open surgery invented by Professor Alfieri (5). Then, other methods were launched, also reflecting surgical techniques in open procedures (6, 7). The first transcatheter mitral valve was implanted in 2012 by Sondergaard in Copenhagen using a transfemoral, transseptal approach. 

However, the mitral valves had big frame diameter and were difficult to fit into low profile introducers for femoral access. In addition, most devices were constructed for transapical delivery. Other issues included that the attachment mechanism did not depend on radial force and finding a way to prevent LVOT obstruction (8–10). There were economical incitements for development, and the valve companies put a lot of effort in engineering and developing the ideal valve, but there is still only one transcatheter mitral valve commercially available in Europe and none in the US.

The tricuspid valve has for a long time been the “forgotten” valve. Open surgery for isolated tricuspid disease has been postponed and avoided. Catheter methods have been developed for the tricuspid valve, facing some of the same issues as the mitral valve, and still no catheter valve is commercially available for the tricuspid valve (11, 12). However, this method may be promising, especially for the redos (13). Though, we are facing the complexity of right heart disease consisting of many factors, not only solved by tricuspid replacement or repair.

For the pulmonic valve, patients are mostly pediatric and GUCH (grown-up congenital heart) cases. The main issue has been the need of stenting prior to valve implantation. There are now specific constructed pulmonic valves in the pipeline.

The need for MDT (multidisciplinary teams) has emerged as the process of catheter treatment develops. There is now a possibility for treatment to groups that were abandoned twenty years ago. At the same time, the patients suitable for surgery want the less invasive method. The endoscopic and robotic surgery methods are refined. Still, we do not know if catheter treatment and open or less invasive surgery are equal. The matter of durability for biological valves remains a question; however, the valve-in-valve techniques are emerging. Mechanical valves may be used in open surgery and last lifelong.

In this innovation process there have been several pioneers. This CTSNet Guest Editor Series focuses on this journey. Each video is presented by a world-renowned cardiac surgeon, each of whom have been specifically invited to summarize the topic for which they are widely recognized to have the greatest expertise, both from Europe and the US. It is my hope that these videos will showcase the treatment options for catheter treatment of all heart valves, but also show the limitations. 

Gry Dahle, MD, PhD
 

Contributor Videos

1. TAVI—Evolution in Landscape by Gilbert Tang

2. Transcaval Transcatheter Aortic Valve Replacement by Chong Bin Lee, Hristian Hinkov, Leonard Pitts, Karl van Praet, Marian Kukucka, Semih Buz, Christoph Klein, Joerg Kempfert, Volkmar Falk, Axel Unbehaun

3. Transcatheter Mitral Valve Replacement: Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC by Kendra Grubb

4. How to Do It: Preventing LVOT Obstruction Valve-in-Valve TMVR by Thomas Modine

5. Transeptal Mitral Annuloplasty: Amend System by Thomas Modine

6. Transapical TMVI: Tendyne Valve by Thomas Modine

5. Current Status of Tricuspid Interventions by Maurizio Taramasso, Edoardo Zancanaro

References

1. Cribier A, Savin T, Saoudi N, Rocha P, Berland J, Letac B. Percutaneous transluminal valvuloplasty of acquired aortic stenosis in elderly patients: an alternative to valve replacement? Lancet. 1986;1(8472):63-7.
2. Andersen HR, Knudsen LL, Hasenkam JM. Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs. Eur Heart J. 1992;13(5):704-8.
3. Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106(24):3006-8.
4. Thourani VH, Edelman JJ, Holmes SD, Nguyen TC, Carroll J, Mack MJ, et al. The International Society for Minimally Invasive Cardiothoracic Surgery Expert Consensus Statement on Transcatheter and Surgical Aortic Valve Replacement in Low- and Intermediate-Risk Patients: A Meta-Analysis of Randomized and Propensity-Matched Studies. Innovations (Phila). 2021;16(1):3-16.
5. Feldman T, Wasserman HS, Herrmann HC, Gray W, Block PC, Whitlow P, et al. Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I Clinical Trial. J Am Coll Cardiol. 2005;46(11):2134-40.
6. Alkhouli M, Rihal CS, Holmes DR, Jr. Transseptal Techniques for Emerging Structural Heart Interventions. JACC Cardiovasc Interv. 2016;9(24):2465-80.
7. Maisano F, Alfieri O, Banai S, Buchbinder M, Colombo A, Falk V, et al. The future of transcatheter mitral valve interventions: competitive or complementary role of repair vs. replacement? Eur Heart J. 2015;36(26):1651-9.
8. Dahle G. Current Devices in TMVI and Their Limitations: Focus on Tendyne. Front Cardiovasc Med. 2020;7:592909.
9. Bapat V, Rajagopal V, Meduri C, Farivar RS, Walton A, Duffy SJ, et al. Early Experience With New Transcatheter Mitral Valve Replacement. J Am Coll Cardiol. 2018;71(1):12-21.
10. Iyer R, Chalekian A, Lane R, Evans M, Yi S, Morris J. Transcatheter Mitral Valve Replacement: Functional Requirements for Device Design, Bench-Top, and Pre-Clinical Evaluation. Cardiovasc Eng Technol. 2018;9(3):301-38.
11. Voci D, Pozzoli A, Miura M, Gavazzoni M, Gülmez G, Scianna S, et al. Developments in transcatheter tricuspid valve therapies. Expert Rev Cardiovasc Ther. 2019;17(12):841-56.
12. Praz F, Muraru D, Kreidel F, Lurz P, Hahn RT, Delgado V, et al. Transcatheter treatment for tricuspid valve disease. EuroIntervention. 2021;17(10):791-808.
13. Dreyfus J, Dreyfus GD, Taramasso M. Tricuspid valve replacement: The old and the new. Prog Cardiovasc Dis. 2022;72:102-13.

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