Highlights from Transcatheter Valve Therapeutics (TVT) 2013

By Xiushui (Mike) Ren, MD, affiliate member of the ACC, reporting live.

TVT 2013: Day 1

TVT 2013 has kicked off to a great start – from live case transmissions highlighting valve-in-valve procedures and the Medtronic CoreValve, to award-winning case presentations, to informative sessions on the latest in transcatheter aortic valve replacement (TAVR) research.

Among the highlights, I had the privilege of hearing Mark Reisman, MD, FACC, give an excellent session on “Aortic Bioskills,” in which he demonstrated the anatomy of the aortic complex during TAVR in cadaveric hearts. He elegantly demonstrated several examples of balloon aortic valvuloplasty and valve implantation with several types of TAVR valves.
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In another session, Susheel Kodali, MD, FACC, gave an excellent presentation on U.S. TAVR commercial release and site training experience. He noted that two-thirds of U.S. PCI sites would not qualify to start TAVR due to their inability to fulfill National Coverage Determination (NCD) requirements that stipulate a hospital must have performed a minimum of 50 aortic valve replacements (AVRs) in the previous year, 1,000 cardiac catheterizations per year, and 400 PCIs per year. In addition, NCD requires potential interventionalists to have at least 100 career structural heart procedures or 30 left-sided structural heart procedures; and requires surgeons to have 100 career AVRs or 25 AVRs in the past year, or 40 AVRs in the past two years. He estimates that roughly 400 programs will fulfill these criteria. Thus far, about 225 sites have been approved to perform TAVR. He also stated that there has been over 6,000 commercial TAVRs performed in the U.S. so far, of which 1,450 are transapical and the remainder transfemoral.

Other interesting sessions, included a presentation by Thomas Walther, MD, about the GARY registry, a European registry that includes both surgical AVR and TAVR patients. According to Walther, this registry showed excellent results for TAVR at 1-year follow-up, but superiority with surgical AVR in low to intermediate risk patients. Cost-effectiveness was also a hot topic, with one study highlighting randomized trial data showing TAVR for inoperable patients to be cost-effective, as well as transfemoral TAVR for high-risk patients. The study found transapical TAVR for high-risk patients was not cost-effective, however.

Finally, Michael Reardon, MD, FACC, discussed various access routes for TAVR, including transfemoral, transpical, direct aortic, and transaxillary. He concluded that, with the availability of ventricular and aortic closure devices in the next few years, direct aortic and transapical approaches will play important roles in TAVR moving forward.

TVT 2013: Day 2

Day 2 of TVT 2013 reveals that the future of TAVR looks bright. John Webb, MD, FACC, gave an overview of novel next generation TAVR systems for the treatment of aortic stenosis (AS). There are over 10 new systems being studied or have already received CE mark in Europe. These have advantages over first-generation valves, including smaller delivery sheath, lower profile, less paravalvular leak, and ability to recapture.

In Aortic Bioskills 3, Dr. Reisman showed the Lotus valve in a cadaveric model which had extensive calcification. In this case, bulky calcification made adequate seating of the TAVR valve challenging.

In Live Case 4, the heart team from the University Heart Center in Hamburg, Germany implanted a Symetis TAVR valve. This live transmission case was successful using the transfemoral technique.

In a session titled "Valve-in-Valve for Bioprosthetic Valve Failure," Vinayak Bapat, MD, spoke about the technical requirements and procedural considerations for valve-in-valve TAVR procedures. He emphasized the importance of identifying the true internal dimension and position of the annulus in this population. Danny Dvir, MD, provided update from the global valve-in-valve TAVR registry. Consistent with TAVR for native valve AS, transfemoral TAVR for valve-in-valve was associated with lower mortality as compared to transapical. Valve malpositioning was higher for stentless prostheses (14 percent) as compared to stented prostheses (8 percent), except for the Medtronic Mosaic valve, which behaved similarly to the stentless prostheses with a malpositioning rate of 14 percent.

Commercial TAVR in the U.S. has FDA approval for inoperable and high-risk AS patients. Whether intermediate-risk patients should receive TAVR is an area of controversy. Martyn Thomas, MD, presented European data on TAVR in intermediate-risk patients. Overall patient risk as assessed by the Euroscore has decreased over the past 3 years, but mortality associated with TAVR has also decreased. Martin Leon, MD, FACC, provided an update of the PARTNER 2A trial. The PARTNER trial was a randomized trial of TAVR versus medical therapy in inoperable patients (cohort B) and TAVR versus surgical AVR (cohort A). The PARTNER 2A trial compared TAVR with the Sapien XT system to surgical AVR in intermediate-risk (STS score >≥4) operable patients. So far, 1500 patients have been randomized, and the median STS score is 5.5. About 78 percent of patients underwent TAVR using the transfemoral route. Nicolas van Mieghem, MD, next provided an overview of the SURTAVI trial, which is a study of TAVR using the Medtronic CoreValve in intermediate-risk patients (STS score between 4 and 10).

Day 2 of TVT was also featured mitral valve therapies and featured percutaneous mitral valve devices for mitral regurgitation. Gregg Stone, MD, FACC, gave a 30-minute year-in-review update on mitral therapies. Advances in echocardiographic assessment of mitral regurgitation, outcomes in surgery for mitral regurgitation, and several sessions on the MitraClip devices brought excitement to the audience.

Visit the ACC’s TAVR Resource Center for additional information on TAVR.

Keywords: Heart Valve Prosthesis, Balloon Valvuloplasty, Cardiac Catheterization, Germany, Europe, Mitral Valve

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