TAVI: the heart of the matter

A few weeks ago, decision-makers in cardiology from around the globe descended on Paris to attend EuroPCR. Alongside TCT in the US, this is one of the biggest, most important gatherings in the field of interventional cardiology—bringing together clinicians, researchers, inventors, industry executives, investors, bankers, and everybody else with an interest in this area. Cardiologists are renowned for their openness to innovation and for rapidly pioneering and adopting bold new therapies: from angioplasty balloons in the 1970s, to coronary stents in the 1980s, and from catheter-based heart valve implantations in the noughties to renal denervation in the current decade. These treatments address major clinical needs and big market opportunities, attracting the attention of large corporate players and start-ups alike. Consequently, cardiology has been a rich source of successful investments in the medical devices space, accounting for a large share of returns to venture investors.

This year at EuroPCR, several themes were prominent: TAVI, renal denervation, next generation stents and drug eluting devices. Additionally, interesting work continues to be done to develop interventional approaches for mitral valve repair/replacement and for treating heart failure.

TAVI

Transaortic Valve Implantation (TAVI)—catheter based procedures and devices for replacing heart valves without open-chest surgery—continued to generate interest, with numerous scientific sessions dedicated to reporting results from second generation devices designed to simplify the procedure and to achieve improved outcomes (eg, reduce stroke rates, post-procedure pacing and paravalvular leak).
German physicians been early pioneers in this field and have the largest case volumes in Europe. The German clinical approach of the “joint heart team”, which combines both interventional cardiologists and cardiac surgeons in unified decision-making, is a model in best-practice and patient centric care. Interventional cardiologists conduct TAVI procedures through trans-femoral (TF) access (eg, MDT/CoreValve), while cardiac surgeons implant through more direct routes such as the trans-apical (TA) access (eg, EW/Sapien). While the TF route can be attractive due to the purely percutaneous nature of the procedure, the TA approach is sometimes necessary due to vascular access issues and, as noted by Dr Hendrick Treede at the TAVI session at EuroPCR, TA procedures can also offer compelling clinical benefits such as lower rates of PV leak and stroke. Under the joint heart team approach, both specialists jointly decide on, and participate in, providing optimal patient care to each patient. This represents a much welcomed “entente cordiale” in the on-going battle for patients between ICs and surgeons. The consequences of this joint decision-making are reflected in clinical practice: in Germany the case-load is roughly 50/50, whereas in other countries it’s typically 70/30 TF/TA. It will be interesting to continue tracking procedure rates and outcomes as adoption of TAVI expands both in volume and location. New technologies will likely influence practice patterns as systems migrate towards lower profiles and TA delivery becomes more “percutaneous” with new access and closure systems that simplify the procedure and eliminate the need for rib-spreading. Several TA access/closure systems were discussed in TAVI sessions, with Apica Cardiovascular presenting the most developed offering so far, as cardiac surgeon and clinical investigator Dr Joerg Kempfert (Kerchoff-Klinik) reported a 100% procedural success rate (n=32) in its CE Mark study.

Market leaders Edwards and Medtronic both presented further results for their existing products and pipeline, as did a number of second generation players including Boston Scientific (Lotus/Sadra), Direct Flow and Symetis. The Acurate TA (trans-apical) from Swiss-based Symetis was noted for its low level of paravalvular leak (an important parameter that’s predictive of long term survival), excellent results achieved and its ease of use (eg, self-expanding, self-positioning). Symetis also presented two successful live cases, one for its Acurate TA (CE marked Sept 2012) and another for its Acurate TF system (currently under clinical evaluation). Here’s a link to the discussion and live case demonstration for both the Acurate TA and TF valves: http://bit.ly/18w9Wo7. With a successful TA product already in the market (over 800 implantations to date) and a TF system expected to be launched later this year, Symetis is poised to be a leading contender in the evolving TAVI landscape. [Disclosure: I’m a board member and investor representative at Symetis.]

One of the big questions around TAVI is the ultimate size of this fast-growing market, which in 2012 was estimated to be $1 billion. Wall Street consensus is that this will grow to a $2-3 billion market by 2017. Longer term, even higher volumes are possible if the use of TAVI migrates from inoperable/high-risk patients to lower risk patients as the long term safety, efficacy and durability of this approach are better established. Regulators and reimbursement authorities are already alive to this issue. Whichever way the market unfolds, this will undoubtedly remain an exciting space as innovative next generation products are introduced and incumbents and new entrants alike battle for market share.

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