In case you missed it… Some very interesting reports came out about the SAPIEN, a non-invasive aortic valve replacement for patients with aortic stenosis that just received FDA approval for inoperable patients, at the recent Transcatheter Cardiovascular Therapeutics conference in San Francisco.

• As reported in Medical News, two-year follow-up findings of the PARTNER trial indicate that transcatheter aortic valve implantation (TAVI) may be a better option than standard treatment. For more, click here.
• As reported at TheHeart.org, a study comparing the transapical approach for transcatheter aortic-valve implantation (TAVI) against conventional aortic-valve replacement surgery was stopped early due to an increase in adverse events, including an increased risk of major stroke and severe paravalvular leakage, in elderly patients eligible for surgery. For more, click here.

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On the heels of our recent discussion about the Sapien, a new transcatheter aortic valve replacement technology, additional data about the MitraClip recently surfaced. Similar to the Sapien, the MitraClip is a non-invasive treatment for heart valve disease. Unlike the Sapien, however, the MitraClip is designed to repair the mitral valve of patients suffering from severe mitral regurgitation.

The MitraClip

In this study, the MitraClip’s performance was compared against traditional surgical approaches including median sternotomy. According to reports, 184 patients received the MitraClip procedure while 95 patients had open heart surgery. The key findings of the EVEREST II study were:

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In case you missed it, some interesting data was just released about the Mosaic porcine heart valve replacement. According to a report in The Journal of Thoracic and Cardiovascular Surgery, the Mosaic bioprosthetic valve — which has been implanted in patients for the past 12 years — continues to demonstrate positive performance.

Mosaic Bioprosthetic Heart Valve Replacement (Porcine Tissue)

As you may know, artificial heart valves are designed to replace diseased heart valves — typically the aortic or mitral valve — which suffer from conditions including stenosis (narrowing heart valve) and regurgitation (leaking heart valves).

Biological heart valve replacements are made from cow (bovine) tissue, pig (porcine) tissue or horse (equine) tissue. While less durable than mechanical heart valve replacements, biological heart valve replacements do not require the patient to take anticoagulants (Coumadin) for the balance of their lives.

The Mosaic heart valve replacement, which received FDA approval in 2000, is made from pig tissue and was designed to protect against post-operative issues including (i) valve calcification and (i) structural degeneration.

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When the latest results of the PARTNER trial became available, many in the medical, investment and patient communities quickly analyzed the data specific to the new SAPIEN heart valve replacement. As you may be aware, the SAPIEN (i) requires no trauma to the sternum during aortic valve replacement, (ii) is currently used for high-risk patients suffering from aortic stenosis, and (iii) has yet to receive FDA approval in the United States.

While many physicians and investors took instant favor to the findings published in The New England Journal of Medicine, I was curious to know what cardiologists and heart surgeons thought of the study — after the data was digested.

For that reason, I contacted several cardiologist and surgeons to discuss this topic. I asked them three questions:

1. Did the recent PARTNER trial results change your views on the utility or performance of the SAPIEN valve replacement device? If no, why not? If yes, how did your view change?
2. What do you feel is the greatest opportunity for catheter-based solutions going forward?
3. What concerns might you have about the SAPIEN technology going forward?

Here are select highlights from this virtual cardiac round table:

QUESTION #1: DID THE PARTNER TRIAL RESULTS CHANGE YOUR VIEWS ON THE UTILITY OR PERFORMANCE OF THE SAPIEN VALVE REPLACEMENT? IF NO, WHY NOT? IF YES, HOW DID YOUR VIEW CHANGE?

Dr. Jeffrey Borer, M.D., President of the Heart Valve Society of America
Before the PARTNER results, I had no views — there were no data and the prosthesis, being experimental, was and is only available in the US in the context of an experimental protocol.

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In case you missed it… Last week, The New England Journal of Medicine published results from the PARTNER Trial, a unique study that examines the safety and efficacy of the new, transcatheter SAPIEN heart valve replacement. Manufactured by Edwards Lifesciences, this investigational device is designed to treat aortic stenosis by replacing the patient’s aortic valve through a catheter — without causing any trauma to the patient’s sternum or ribs.

Edwards Sapien Heart Valve Replacement

Needless to say, the medical community, the investment community and our patient community have been anxiously awaiting results of this study for the SAPIEN device — which has yet to receive FDA approval in the United States.

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