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.

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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

Small Study Explores Expanded Use For TAVI In Native Valve Aortic Regurgitation Reply

As transcatheter aortic valve implantation (TAVI) gains increasing acceptance, cardiologists and surgeons are exploring additional patient populations who may benefit from the procedure. A new paper in the Journal of the American College of Cardiology provides the first look at the use of TAVI in the small but important group of patients with pure, severe native aortic valve regurgitation (NAVR) who do not have aortic stenosis.

The authors acknowledge that TAVI will likely be used sparingly in the NAVR population:

…although these results are encouraging for those patients who are truly ineligible for surgery, surgical valve replacement remains the gold standard for those who can undergo it, even at high risk. Furthermore, there is an increasing number of patients in whom the native aortic valve can be preserved during surgery.

Click here to read the full story on Forbes.

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.

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.

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:
Click to continue reading…

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
Click to continue reading…

Consensus Document Provides Roadmap To Uptake Of TAVI In US 3

Following the recent approval by the FDA of transcatheter aortic valve replacement (TAVR), the ACC, AATS, SCAI, and STS, in conjunction with several other medical organizations, have released a critical consensus document to guide use of the new landmark procedure.

“We have tried to collate the evidence into a coherent road map for judicious use, rational dispersion, and careful post-marketing scrutiny of this promising technology,” said Sanjay Kaul, vice chair of the writing committee, in a press release. “It is now the collective responsibility of all the stakeholders to optimize its full potential for improving the duration as well as the quality of survival in patients with severe symptomatic aortic valvular stenosis.”

Here are some of the key recommendations identified by the committee:

–Careful patient selection

–Team-based approach given the complexity of procedure coupled with the high-risk profile of suitable patients, many of whom have extensive comorbid conditions that require ongoing management

–Specialized heart centers and physician expertise in treating valve disorders; this includes use of proctors as needed to serve on the heart care team during the first few cases, as well as proper facilities (hybrid operating rooms or modified cath labs)

–TAVR screening tests to inform treatment decisions

–Enhanced patient and family education in the risk and benefits of this procedure

–Ongoing evaluation and participation in national TAVR registry to assess real world outcomes

The document also emphasizes the groups for whom TAVR is not recommended:

–An acceptable surgical risk for conventional surgical AVR

–Known bicuspid aortic valve

–Severe mitral annular calcification or severe MR

–Moderate AS

–Other (e.g., severe AR and subaortic stenosis)

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