Will Edwards Snatch Defeat From The Jaws Of Its Victory Over Medtronic? Reply

On the heels of a sweeping victory in the courts over its rival MedtronicEdwards Lifesciences is poised to dominate the TAVR (transcatheter aortic valve replacement) market– the revolutionary new catheter technology that offers some patients with life-threatening aortic valve disease an alternative to chest-splitting surgery. Although the legal wrangling is not quite over– Medtronic is appealing the decision and has requested that enforcement of the injunction be postponed– it appears likely that Edwards will ultimately achieve a broad legal and business victory.

But Edwards’ unprecedented victory also presents an unprecedented challenge to the company. While the court appears to have given Edwards everything it wished, the ultimate result could produce significant harm to Edwards’ relationship to the interventional cardiologists who are its core customers. More importantly, there is now a distinct possibility that at least for several years many people who could possibly benefit from the Medtronic technology will not be able to get it.

A Decisive Victory

In last week’s ruling a federal judge delivered a broad ruling in favor of Edwards:

Click here to read the full post on Forbes.

 

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New Medtronic Heart Valve Threatened By Court Decision Reply

A legal injunction may severely limit the availability in the United States of Medtronic’s CoreValve device, which only received FDA approval earlier this year. The device received abundant praise recently when a large clinical trial demonstrated substantial advantages for CoreValve over traditional open-heart surgery.

The injunction is the latest episode in an ongoing patent war in which Edwards Lifesciences, which pioneered the field of transcatheter aortic valve replacement with its Sapien devices, has sought to hinder Medtronic from competing in the US and international markets.

Click here to read the full post on Forbes.

 

First TAVR Comparison Trial Favors Sapien XT Over CoreValve Reply

With two devices now approved for transcatheter aortic valve replacement (TAVR), the marketing battle has begun to win the hearts and minds of cardiologists. On Saturday at the ACC, Medtronic gained bragging rights showing the first mortality benefit for its CoreValve device. A similar improvement did not occur in the PARTNER trials with the Edwards Sapien device, but all the experts have warned against cross-trial comparisons. Now an actual randomized trial has emerged comparing the two platforms. The results favor the Sapien XT, but the size and scope of the trial mean that the discussion and debate will certainly continue.

Click here to read the entire post on Forbes.

 

 

Survival Advantage for TAVR Over Surgery in High-Risk Patients Reply

Transcatheter aortic valve replacement (TAVR), which has been slowly and cautiously entering the clinical arena, will probably get a big boost from a new trial showing a significant mortality advtange for TAVR over traditional surgery.

Results from the U.S. CoreValve High-Risk Study were presented at the American College of Cardiology in Washington, DC, and published simultaneously in the New England Journal of Medicine.

Click here to read the full post on Forbes.

 

 

What To Expect At The American College of Cardiology Meeting Reply

The ACC begins this Saturday in Washington, DC. Here’s a preview of some of the most highly-anticipated late-breaking clinical trials.

On Saturday morning at the opening session the world will finally learn more about the failure of Symplicity HTN-3, the Medtronic trial of renal denervation….

 Click here to read the entire post on Forbes.

 

French Surgeons Perform First Aortic Valve Surgery Without Opening The Chest Reply

Surgeons in France report that they have performed the first total endoscopic aortic valve replacement (TEAVR) in 2 human patients. Their paper has been published in the the Journal of Thoracic and Cardiovascular Surgery [subscription required].

The new procedure may enable surgeons to replace the aortic valve without opening the chest, though it will still require cardiopulmonary bypass and excision of the old valve. The key to the new procedure is the recent availability of sutureless aortic valve bioprostheses, in this case  the Medtronic 3f Enable bioprosthesis. In recent years these devices have allowed surgeons to develop “minimally invasive” surgical techniques. The new report is about the first surgical procedure in which the chest is not opened and the procedure is performed entirely through endoscopes.

Click here to read the entire post on Forbes.

 

Heart Societies Issue New Guidelines For Valve Disease Reply

The American Heart Association and the American College of Cardiology today released new practice guidelines [PDF] for the management of patients with valvular heart disease (VHD). Among its most notable features, the new document provides a new system of classification for VHD and lowers the threshold for interventions, including, for the first time, transcatheter as well as surgical interventions.

Click here to read the full post on Forbes.

 

FDA Grants Earlier Than Expected Approval For Medtronic’s CoreValve Reply

The FDA today approved Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis who are unable to undergo conventional open-heart surgery. The approval came several months ahead of expectations and without an FDA advisory panel meeting.

Click here to read the full post on Forbes.

CoreValve Family Sizing

Edwards CEO Sold Stock 2 Weeks Before It Tanked 2

(Updated) Earlier this week the stock of Edwards Lifesciences tanked after the company announced weak Sapien sales and lowered its sales guidance for the rest of the year. The stock, which had been trading in the low 80s for the past month, dropped a heartbreaking 22% on Wednesday in response to the news and closed at 65 on Thursday.

But Edwards chairman and CEO Michael Mussallem didn’t suffer along with his shareholders. As reported by GuruFocus, Mussallem sold 35,000 shares of his stock on April 10 at 83.37 per share netting him nearly $3 million. Another executive, the corporate VP of Japan and Intercontinental, Huimin Wang, sold 4,850 shares at $81.74 per share.

The dramatic drop in Edwards’ stock is another sign that the market for transcatheter heart valves has not grown as rapidly as many had expected. “Edward’s initial 2013 guidance clearly proved to be overly aggressive on U.S. TAVR sales as capacity constraints and the complexities of bringing a 20+ person team up the learning curve clearly tempered the adoption curve more than expected,” said a Leerink Swann analyst quoted by Bloomberg.

Update: I have been informed by Edwards that the recent sale was part of a predetermined plan to sell shares. Mussallem has sold 35,000 shares each month since June of 2012.

FDA Issues Warning Letter To CoreValve Investigator Reply

The FDA has issued a warning letter to an investigator in the Medtronic CoreValve US Pivotal Trial. The letter cites numerous serious violations relating to the treatment of subjects in the trial testing the experimental Medtronic TAVI (transcatheter aortic valve implantation) device. The violations were uncovered during an FDA inspection last summer.

The subject of the FDA warning is Michael Ring, one of the two principal investigators of the CoreValve trial at the Providence Sacred Heart Medical Center site in Spokane, WA.

Click here to read the full story on Forbes. (Updated to include an additional comment from Dr. Ring.)

English: A warning sign with an exclamation mark

ACC And STS Break New Ground To Test TAVR For Unapproved Uses Reply

In a startling break with tradition, the American College of Cardiology and the Society of Thoracic Surgeons will manage and run their own clinical trials testing expanded uses for transcatheter aortic valve replacement (TAVR). The two medical groups have recently been granted an investigational device exemption (IDE) by the FDA for one such trial and hope to gain an IDE for at least two more trials. The news was first reported by The Gray Sheet (subscription required) on February 8.

The new development represents a significant enlargement of the TVT registry, already run by the ACC and STS, which tracks all TAVR usage in the US.

Click here to read the entire post on Forbes.

ACC STS TVT logo

2012 In Review: A Bad Year For Conventional Wisdom 3

This was a really grim year for anyone who thought we had things pretty well figured out. Time and again conventional wisdom was thrown out the window. 2012 forced the cardiology community to reconsider what it thought it knew about HDL cholesterol, platelet function tests, aspirin resistance, triple therapy, IABP, and more.

One device company, with a lot of help, did just about everything right when it introduced a radical, highly disruptive new technology. Another device company did just about everything wrong in handling a series of crises. The new generation oral anticoagulants continued to make gains– slowly– but also failed to achieve the early blockbuster success that some had thought they might achieve.

And it was another bad year for scientific integrity.

Conventional Wisdom Isn’t

Raising HDL cholesterol had to be great. Then the evidence arrived. Just last week HPS2-THRIVE put the final  nail in the niacin coffin. (I wonder what all the critics of AIM-HIGH have to say now?) And another CETP inhibitor bit the dust. The HDL hypothesis is far from dead, but any claim of benefit due to raising HDL will need to be rigorously demonstrated in a large, well-designed clinical trial.

Platelet function tests just had to be useful in guiding therapy. Then ARCTIC came along and blew a cold wind on the idea.

On a related note, many believed that testing for aspirin resistance might be a good idea. Then a paper in Circulation presented strong evidence that the entire concept of aspirin resistance might be a myth.

Triple therapy for PCI patients already receiving anticoagulation was standard clinical practice, endorsed by the guidelines. Now, after WOEST, we know that what we knew was wrong. Drop the aspirin.

Intraaortic balloon counterpulsation (IABP) has a class 1 recommendation for patients in cardiogenic shock following myocardial infarction for whom early revascularization is planned. Until IABP-SHOCK II was presented at the ESC and published in NEJM.

Depending on your perspective the FREEDOM trial either confirmed or denied conventional wisdom. We now know with near certainty that diabetics with multivessel disease have better outcomes with CABG than with PCI. An important lesson from an important trial.

Conventional wisdom had it that chelation therapy was worthless. The conventional wisdom may still be valid, but the NIH’s TACT trial means the debate will continue. It’s hard to imagine a satisfactory result to this controversy, despite the good intentions of the NIH and at least some of the TACT investigators. In general I support the concept of testing alternative therapies, especially if they gain traction in clinical practice, but it’s not clear yet whether we really learned anything from TACT (except that doing trials like this is extraordinarily hard). A trial like TACT should only be performed if it has a good chance of actually answering the big clinical question. Unfortunately, TACT didn’t do this.

TAVR: Bright Spot in a Dark Year

Click to continue reading…

TCT: Impressive Survival Benefit For TAVR In Inoperable Patients At 3 Years Reply

At the TCT meeting in Miami  Murat Tuzcu presented the latest findings from the PARTNER B trial comparing transcatheter aortic valve replacement (TAVR) with standard therapy in patients who are not considered eligible for surgical valve replacement. At three years the mortality advantage continued to grow for TAVR over standard therapy in patients who are not eligible for surgery.

All cause mortality at 3 years:

  • 80.9% in the control group versus 54.1% in the TAVR group (HR 0.53, CI 0.41-0.68, p<0.0001)

The difference between the groups has increased from from an absolute difference of 20.1% at 1 year (50.8% versus 30.7%) to 25% at 2 years (68% versus 43%) to 26.8% at 3 years. Here are the other 3 year endpoints reported by Tuzcu:

Rehospitalization at 3 years:

  • 75.7% versus 42.3% (HR0.39, CI 0.28-0.54, p<0.0001)

Mortality or reshospitalization at 3 years:

  • 93.1% versus 66.3% (HR 0.46, CI 0.36-0.58)

Mortality or stroke at 3 years:

  • 80.9% veruss 57.5% (HR 0.60, CI 0.46-0.77, p<0.0001)

The three year results, concluded Tuzcu, “continue to support the role of TAVR as the standard-of-care for symptomatic patients with aortic stenosis who are not surgical candidates.” As well, the results “underscore the importance of patient selection before TAVR and the need for aggressive management of illnesses after TAVR.”
Click here to read the press release from Edwards…

FDA Approves The Sapien Transcatheter Heart Valve For High Risk Patients 2

The FDA today approved an expanded indication for Edwards Lifesciences’ Sapien transcatheter heart valve (THV). The device can now be implanted in patients who are eligible for aortic valve replacement surgery but at high risk for serious surgical complications or death. Previously the Sapien valve was approved only for use in patients who were not eligible for surgery.

The FDA also said the device could be delivered through both the transfemoral route and the transapical route. Previously the device could only be delivered through the transfemoral route.

“Any procedure to replace the aortic valve carries the risk for serious complications, but for some patients with coexisting conditions or diseases that risk may be especially high,” said the FDA’s Christy Foreman, in an FDA press release. “The THV serves as an alternative for some very high-risk patients.” The FDA requires that before being deemed eligible for the Sapien valve a patient must be evaluated by a heart team, which includes a heart surgeon.

The new approval in high risk patients was based on findings from the PARTNER A trial. The earlier approval in non-operable patients was based on findings from the PARTNER B trial.

The FDA will continue to require Edwards to evaluate the Sapien device through a national registry.

Click here to read the FDA and Edwards press releases…

TAVI: Belgian Researchers Slam Evidence Base And Overuse In Europe 1

The growing and enthusiastic adoption of transcatheter aortic valve implantation (TAVI) in Europe has no justification, according to three researchers who performed a health technology assessment for the Belgian government. In a paper published in BMJ, the authors from the Belgian Health Care Knowledge Centre conclude that TAVI should only be used in patients “who are deemed inoperable for technical reasons,”  which is about 10% of patients “of those currently considered for treatment.”

In their paper the writers do not identify any new concerns about TAVI, but they weave together the various threads of criticism that have been directed at the dissemination of TAVI. Hans Van Brabandt, Mattias Neyt, and Frank Hulstaert also charge that the evidence base for TAVI is deeply flawed as a result of an unpublished negative trial, serious baseline imbalances between controls and TAVI patients in the PARTNER trial, and unreported conflicts of interest by the principal investigator of PARTNER.

By the end of 2011 approximately 40,000 TAVI procedures had been performed, they write. Nearly all of the procedures were performed in Europe, where devices do not undergo the same regulatory scrutiny as drugs, needing only a CE mark to go on the market, “putting them on the same footing as domestic appliances such as toasters.” They note that TAVI was used in Europe for four years before the FDA approved its use in the US, but only for patients who were not surgical candidates and only when the transfemoral approach was used.

Despite the greater rigor of the US regulatory process, the authors write that after their careful review of all the available evidence “we remain far from convinced that it is adequate” and that “the arguments supporting the widespread use of TAVI do not stand up to scrutiny.”

Although in  the PARTNER A trial TAVI met the predefined criteria for non-inferiority when compared to surgery, the authors write that strokes, TIAs, and major vascular complications occurred more often with TAVI. TAVI performed better in the PARTNER B trial, which studied patients who were not eligible for surgery, but TAVI was still associated with a higher rate of stroke and vascular events. Results of the two trials “suggest that TAVI can be justified for inoperable patients on clinical grounds,” but, write the authors, this conclusion is weakened because the FDA, Edwards (manufacturer of the Sapien TAVI device), and trial investigators have failed to provide data to the authors, despite repeated requests, about a follow-up study comparing TAVI to standard therapy in 90 patients. The failure to share the data, they write, “is both ethically and scientifically unacceptable and should be legally regulated in future.”

The authors also maintain that  the principal investigator of the PARTNER trial, Martin Leon, did not fully disclose his financial interest in TAVI. Although it was disclosed in the NEJM papers that Leon had received $6.9 million from Edwards when it purchased Percutaneous Valve Technologies, which Leon had co-founded, the articles did not mention that Leon “was to receive three further payments on the achievement of three milestones: successful treatment of 50 patients, regulatory approval in Europe, and limited approval in the US.”
Click to continue reading, including a comment from Sanjay Kaul…

The Name Game: Why Did “TAVI” Suddenly Become “TAVR”? 2

One of the great, unexplained mysteries of the cardiology world in recent years is the sudden name change from TAVI  (transcatheter aortic valve implantation), which had been the universally-used name for the procedure during most of its development period, to TAVR  (transcatheter aortic valve replacement) about the time when the procedure edged closer to US approval.

Now, in a clever letter published in the Journal of the American College of Cardiology, Stacey Clegg and Mori Krantz “humbly suggest reversion to the archaic name transcatheter aortic valve implantation (TAVI).” When the procedure is explained to potential patients, they write:

We gracefully explain that we blow up a balloon, smash the old valve to the side, then implant a new one within their existing annulus. Their reaction is often one of bewilderment. This confusion is well founded. Webster’s dictionary defines replace as “to put something new in place of something else,” and implies filling a place once occupied by something removed. One does not have a muffler replaced at the local auto shop and expect to find the old one still in place. Technically, we are performing valve displacement. However, a valve displacement doesn’t sound like an advanced restorative therapy that marketing experts would embrace.

Clegg and Krantz write that TAVI was still in use in 2010 when the first PARTNER trial was published in the New England Journal of Medicine (“Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery”) but the acronym had been somehow magically transformed by 2011 when the second PARTNER trial was published in NEJM (“Transcatheter Versus Surgical Aortic-Valve Replacement in High-Risk Patients”).

Clegg and Krantz argue that “TAVI” should be restored as “the acronym of choice”:

Why does this matter? We contend that this is not merely semantic, because an accurate name for high-risk expensive procedures is pertinent to healthcare stake holders. It facilitates uniform communication among researchers, payers, regulators, clinicians, and, most importantly, patients. In a clinical landscape cluttered with jargon, we should strive toward verbal precision. Politicians, poets, and pollsters know that words matter. Powerful words launch social movements and even cultural revolutions. The right catch phrase also can launch a new product. However, there should be truth in advertising, and our regulatory bodies should be critical in determining if advertising is misleading or fails to disclose all the relevant facts.

There is one issue about the name change not addressed by Clegg and Krantz, and here we leave the idealistic world of semantics and philosophy and enter the hard-edged world of economics and finance. At the time of the change from TAVI to TAVR there were numerous rumors and speculations about the real reason for the change. Reimbursement for the procedure, the theory goes, would be much higher if it were based on a comparison with surgical replacement rather than surgical repair.

FDA Advisory Panel Recommends Expanded Indication For Sapien Transcatheter Heart Valve Reply

The FDA’s Circulatory System Devices Panel voted overwhelmingly on Wednesday to recommend an expanded indication for the Edwards Sapien Transcatheter Heart Valve in patients with symptomatic severe aortic stenosis who have high operative risk. The device is currently approved for use only in patients who are not surgical candidates.

The committee voted 10-2 that the Sapien device was safe, 12-0 that it was effective, and 11-0, with 1 abstention, that the benefits of the device outweigh the risks. Much of the day was spent by committee members wrestling with a number of difficult questions raised by FDA reviewers prior to the meeting, including the possible introduction of bias in the pivotal PARTNER A trial  because some patients randomized to surgery did not undergo surgery, the difficulty of evaluating the transapical approach due to the small number of patients randomized in that stratum of PARTNER, and the higher incidence of stroke and aortic regurgitation in the Sapien group.

Ultimately, however, the committee was persuaded by the totality of the data from PARTNER and additional nonrandomized data from patients who received the device under a continued access protocol. An additional strong source of reassurance for the panel was the safeguard provided by the TVT registry, a joint initiative from the Society of Thoracic Surgeons (STS) and The American College of Cardiology (ACC) that will closely monitor the use of TVR in clinical practice.

In sharp contrast to many recent advisory committee meetings, this panel was marked by the absence of drama and tension. A high point of the meeting for many observers was the public comment session. One speaker was a 92-year-old Sapien recipient who was a World War II veteran and prisoner or war who had survived the Bataan Death March. Another patient who spoke in favor of Sapien was the father of well-known Columbia University interventional cardiologist Jeffrey Moses, who helped develop the device. Moses said that he “wisely” chose to stay out of the case, though initially he did help persuade his father to accept the device after he refused to undergo surgery.

Related reading: 

Live Blog: FDA Advisory Panel For Edwards Sapien Transcatheter Heart Valve Reply

Here’s my live-blog of the FDA’s meeting of the Circulatory System Devices Panel to consider the premarket approval (PMA) application for the Edwards Sapien Transcatheter Heart Valve for use in patients with symptomatic severe aortic stenosis who have high operative risk. As reported here earlier this week, FDA reviewers have raised a number of questions about the safety and efficacy of the Sapien heart valve system. Here is a link to the FDA and Edwards briefing documents.

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Meeting adjourned.

6:00– The committee votes 10-2 that Sapien is safe, 12-0 that it is effective, and 11-0 (1 abstention) that the benefits outweigh the risks. 

5:55– Here’s questions 2 and 3:

VOTING QUESTION 2: Is there reasonable assurance that the Edwards SAPIENTM Transcatheter Heart Valve is effective for use in patients who meet the criteria specified in the proposed indication?

VOTING QUESTION 3: Do the benefits of the Edwards SAPIENTM Transcatheter Heart Valve for use in patients who meet the criteria specified in the proposed indication outweigh the risks for use in patients who meet the criteria specified in the proposed indication?

5:54– Wow– computer voting system is broken! They’re going to vote on paper.

5:48– After they finish the legal mumbo jumbo the voting will begin.

5:43– Getting close to the voting questions. Here’s #1:

VOTING QUESTION 1: Is there reasonable assurance that the Edwards SAPIENTM Transcatheter Heart Valve is safe for use in patients who meet the criteria specified in the proposed indication?

5:39– Edwards via Craig Smith giving their summary. He says he’ll be brief.

5:38– Now talking about study data that should be included in the labeling.

5:30– Now talking about post-approval studies to get further insights into stroke, aortic regurgitation, long term effectiveness, valve-in-valve, and gender issues.

5:28– Now discussing the totality of the evidence. Chairman states that the committee agrees that Sapien is safe and effective, with a number of caveats, such as stroke, TA/TF, gender, AR. (Why bother voting now?)

5:20– Committee now discussing informed consent and whether a more detailed informed consent form should be required. An additional piece of paper is not really the ideal solution.

5:15– Chairman summarizes that the FDA is concerned that valve-in-valve use may occur, but there’s no data to support this. Committee strongly encourages getting data on this and it should not be endorsed on the label. Committee wants to motivate the company to perform a separate clinical trial for this indication.
Click to continue reading…

FDA Reviewers Raise Questions About Sapien Heart Valve System 1

FDA reviewers have raised a number of questions about the safety and efficacy of the Sapien heart valve system. The review was published online ahead of Wednesday’s meeting of the Circulatory System Devices Panel meeting to evaluate the Sapien system for use in patients eligible but at high risk for aortic valve surgery. The Sapien system was previously approved in November 2011 for patients not considered surgical candidates for aortic valve replacement.

The FDA briefing document cites numerous examples of possible bias in the pivotal PARTNER A trial. The most serious problem appears to be caused by the high number of patients randomized to surgery who did not undergo surgery, including 7.9% who refused treatment or withdrew from the study. By contrast, only 0.3% of TAVR patients refused treatment or withdrew from the study. Surgical patients were also more likely to receive concomitant operations, another possible source of bias.

Another important topic of discussion will undoubtedly be the differences in outcome between patients receiving the transapical (TA) and transfemoral (TF) approaches. Unlike the TF stratum, where mortality was lower in the Sapien group, in the TA stratum mortality was higher in the Sapien group. Because there were only a relatively small number of patients in the TA group in the PARTNER trial, the panel will also consider TA patients treated outside the context of randomized trials.

The FDA reviewers were also concerned about stroke and aortic regurgitation. In the first 30 days the stroke rate was doubled in the Sapien group, and there were more strokes overall in the Sapien group in the TA stratum. Concern was also raised about the 53% of Sapien-treated patients who had mild or greater aortic insuficiency.

One interesting point raised by the FDA is that transcatheter aortic valve replacement (TAVR) is not nearly as noninvasive as many have been led to believe:
Click to continue reading…

Politics and Transcatheter Aortic Valve Replacement 2

Scott Gottlieb, MD

From the first early stages of its development, the prospect of transcatheter aortic valve replacement (TAVR) provoked two broad and competing fears:

  1. Regulatory safeguards would kill a promising new technology, denying its life-saving benefits to many thousands of desperately sick people.
  2. The stampede to stake a claim in a promising, highly lucrative new territory would lead to the exploitation and mistreatment of many thousands of desperately sick people.

Remarkably, neither scenario occurred. Instead, at a very early stage, medical societies, regulators, and industry worked together to ensure the smooth introduction of TAVR in the US. The final decision earlier this week by the Centers for Medicare & Medicaid Services (CMS) to provide reimbursement for TAVR was the latest step in a long, ongoing process that, for once, didn’t appear broken, and, in fact, represented an unusual consensus among physicians, regulators, insurers, and other involved parties.

However, in an apparent attempt to inject politics where it’s neither needed nor wanted, Scott Gottlieb, a conservative activist who is a former FDA deputy commissioner and CMS adviser, concludes that the CMS ruling means “that for costly procedures, Washington will be making more of these choices for us.” In a posting on the American Enterprise Institute’s The Enterprise BlogGottlieb writes that the decision “is a vivid example of how our healthcare is going to get reimbursed now that Washington calls more of the shots.”

Gottlieb doesn’t make a clear statement that explains his hostility to the CMS decision. Instead, he cites several facts that he thinks makes his case for him. He’s wrong.

For instance, Gottlieb writes:

CMS is also restricting the number of doctors that can perform the new procedure.

Actually, CMS has done nothing of the sort. It has insisted that doctors who perform the procedure have adequate training and that the hospitals where the procedures are performed have sufficient experience and adequate facilities. Perhaps Gottlieb would be happy to send an elderly relative for TAVR  to a local community hospital with little experience in the procedure. It was precisely to avoid this scenario that the American College of Cardiology and the Society of Thoracic Surgeons supported CMS in this coverage decision. I fail to see how anyone would benefit by widespread proliferation of TAVR by novice operators at inexperienced centers.
Click to continue reading…

CMS Issues National Coverage Decision for TAVR 1

The Centers for Medicare & Medicaid Services (CMS) today issued its national coverage decision (NCD) for  transcatheter aortic valve replacement (TAVR). As expected, CMS will offer reimbursement for TAVR, but only if a number of criteria are first met. The NCD was initially requested by the American College of Cardiology and the Society of Thoracic Surgeons, responding to concerns that TAVR approval might lead to a stampede of implantations as cardiologists, surgeons, and hospitals sought to stake a claim in a major new territory.

The NCD decision memo outlines a series of conditions that must be met for CMS reimbursement:

  1. The use of an FDA approved device for an FDA approved indication.
  2. Evaluation of the patient by 2 cardiac surgeons.
  3. Performance of the procedure at an institution with sufficient surgical and interventional cardiology experience and expertise, including participation in a prospective national TAVR study and a commitment to the heart team concept. (The memo provides details on two sets of qualifications: one for hospitals without previous TAVR experience and the second for hospitals with TAVR experience.)
  4. Performance by physicians with sufficient experience and expertise.
  5. The patient must be enrolled in, and the physician must participate in a national TAVR registry.

CMS also said it would provide coverage for patients enrolled in clinical studies for new indications, as long as the trials meet a long list of criteria. CMS said that coverage would be denied for indications other than those specifically mentioned in the memo.

PARTNER: TAVR Results Appear Durable at Two Years Reply

Two year results of the influential PARTNER trial provide continued support for the growing acceptance of transcatheter aortic valve replacement (TAVR) in clinical practice. Previously, results of PARTNER at one year had demonstrated a similar mortality in high risk patients with aortic stenosis who received TAVR and surgery. The two year results were presented at the American College of Cardiology and published simultaneously in the New England Journal of Medicine.

Two year mortality:

  • ITT analysis: 33.9% in the TAVR group versus 35% in the AVR group (HR 0.90, CI 0.71-1.1, p=0.78)

Stroke at 2 years:

  • 7.7% versus 4.9% (HR 1.22, CI 0.67-2.23, p=0.517)

All cause mortality or stroke at 2 years:

  • 37.1% versus 36.4% (HR 0.96, CI 0.76-1.21, p=0.700)

The PARTNER investigators reported that the valve gradients and areas were similar between TAVR and AVR at two years and that they had found no evidence of structural valve deterioration. However, peri-procedural aortic regurgitation was a highly significant predictor of late mortality (p<0.0001).

“We’re most concerned about valve durability, which you have to look at over five to 10 years, but any longer-term information is useful because trends tend to hold true over time,” said Susheel Kodali, who presented the results, in an ACC press release. “We have no evidence that the initial good results in improved valve performance have deteriorated during the follow-up to this time point. TAVR appears to be as durable as AVR.”

“During this follow-up, we observed that significant leakiness around the valve was associated with higher subsequent mortality in TAVR patients, but it’s important to note that overall mortality between the two groups is the same,” he said. “Now we have a target – we know what to fix in the future. TAVR is already comparable to results for AVR in the most experienced surgeons’ hands. If we can reduce these leaks, there’s a good chance we can reduce mortality with TAVR even more.”

The PARTNER investigators concluded that the study “supports the use of TAVR as an alternative to surgery in selected high-risk patients with aortic stenosis.”
Click here to read the press release from the ACC…

Four Cardiovascular Societies Release Criteria for TAVR Programs and Operators 1

A newly released statement contains detailed recommendations about the requirements necessary for hospitals and physicians to participate in transcatheter aortic valve replacement (TAVR)  programs. The expert consensus document was released jointly by the American College of Cardiology Foundation (ACCF), the Society for Cardiovascular Angiography and Interventions (SCAI), the American Association for Thoracic Surgery (AATS) and the Society for Thoracic Surgeons (STS).

The statement is the latest result of the coordinated effort from medical societies and regulators to effect a smooth introduction of this potentially disruptive new technology. The same four societies earlier released a consensus document that provided a roadmap for the uptake of TAVR in the US, which was followed soon thereafter by the release from CMS of details of its proposed national coverage for TAVR.

The document emphasizes “a formal collaborative effort between cardiologists and cardiothoracic surgeons as the cornerstone for establishing a successful program, noting that a program without both specialties would be fundamentally deficient,” according to a press release issued by the societies.

The statement contains specific details about:

  • Annual heart (aortic valve) surgery and percutaneous coronary intervention (PCI) volume requirements for institutions.
  • Board certification and procedural requirements for both surgeons and interventional cardiologist.
  • Monitoring of complication rates and institutional follow up.
  • Participation in a national registry that will include enrollment of all patients undergoing TAVR with continued tracking of outcomes.
  • Commitment to a heart team concept that is led by the surgeon and interventional cardiologist and made up of a formal collaborative effort among all medical team members. In all TAVR procedures, the interventional cardiologist and surgeon must both be present during the entire procedure ensuring joint participation and optimal patient-centered care.

Click here to read the press release from SCAI, AATS, ACCF, and STS…

Slow Uptake of Transcatheter Aortic Valves: Learning from History? Reply

Transcatheter aortic valve replacement (TAVR) has been one of the most exciting new developments in cardiovascular medicine in recent years. The growing enthusiasm over TAVR led to concern and even alarm in some quarters that the introduction of TAVR would ignite a stampede of uptake, mirroring the early over-enthusiasm for similarly disruptive devices like stents and ICDs, leading to repeated cycles of criticism, investigations, and pullbacks.

Early signs now indicate that history may not be repeating itself and that the careful and deliberate introduction of TAVR may result in an entirely different pattern. Remember that ACC and STS requested a National Coverage Decision (NCD)from CMS and, following the initial approval of TAVI, released a critical consensus document offering a roadmap to responsible introduction of the new procedure.

Wells Fargo medical device analyst Larry Biegelsen (email), attending the STS/ACCF Transcatheter Heart Valve (THV) Symposium in Chicago last week, reports that uptake of the Edwards Sapien device has been slow, suggesting that the measured approach advocated by the ACC and STS and others has had an impact.

He cites three reasons for the slow uptake:
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CMS Releases Details Of Proposed National Coverage For TAVR 5

(Updated with statement from the ACC and STS)

On Thursday the Centers for Medicare & Medicaid Services (CMS) released a memo containing details of its proposed Medicare coverage for TAVR (transcatheter aortic valve replacement). The memo is a response to a formal request for national coverage determination (NCD) from the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC). The memo will be open for public comment until March 3, after which a final determination will be made.

In the memo CMS proposes coverage for TAVR only if 5 conditions are met, including
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