Societies Issue Recommendations for Operators, Institutions Offering LAA Closure Procedures

Three medical professional organizations have teamed up to express their concerns with the Centers for Medicare & Medicaid Services (CMS)’s proposed decision memo covering reimbursement for the Watchman left atrial appendage (LAA) occluder and set out some benchmarks for training and proficiency in the use of these kinds of procedures.  

The expert consensus paper, developed by the Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology (ACC) and the Heart Rhythm Society (HRS), was published online ahead of print in Catheterization and Cardiovascular Interventions, Journal of the American College of Cardiology, and Heart Rhythm.

The paper, as well as a letter being sent to CMS by the societies, constitutes a response to the agency’s 30-day public comment period following a proposed decision memo that was released in November. A National Coverage Decision is expected in February, said Clifford J. Kavinsky, MD, PhD, the document’s lead author.

“The three societies represent individuals who are experts in this area, so you would hope that CMS would listen to the experts who are knowledgeable about this rather than just deciding on their own,” Kavinsky, of Rush University Medical Center (Chicago, IL), told TCTMD in a telephone interview.

Two Steps Forward, One Step Back

The recommendations set out in the consensus paper are closely aligned with those released by CMS in their proposed decision memo. That document outlined 7 conditions that needed to be met in order for CMS to pay for LAA closure using an implanted device.

But Kavinsky said the 3 societies had issues with several of those conditions and outlined their concerns in the letter. Most notable is the position by CMS that patients should have a high CHADS₂ or CHA₂DS₂-VASc score and a high HAS-BLED score as well as a contraindication to warfarin.

“The FDA approval for the Watchman states that patients have to be eligible to take warfarin. All the randomized controlled trials only included patients who could take blood thinners,” Kavinsky said. The consensus paper instead defines contraindications and states that patients must have a high stroke score and either a high bleeding score or a contraindication.

Also at issue is the use of proctors. CMS says physicians must undergo training on the safe and effective use of the device prior to performing procedures by a physician proctor who already has experience implanting the device. But the proposal also states that physician proctors not be a representative of the manufacturer and not be compensated.

“The only people who do this procedure are those who participated in the randomized trials and have the experience putting the device in,” Kavinsky said. The societies state in their letter to CMS: “Quality proctors need to be compensated and we believe it would be counterproductive to have proctors who have no remuneration for their time and expertise and no relationship with the device manufacturer.”

SCAI, ACC and HRS assert in the consensus document that participation in a national registry should be mandatory, and that individual institutions should come up with processes to regularly review their center-wide and physician-specific results. Furthermore, they recommend that institutions providing LAA closure have protocols for follow-up that obtain echocardiographic and other imaging data that identify the presence and severity of persistent leaks; details on medication use (particularly anticoagulants); and rates of clinical outcomes including bleeding, neurologic events, and device complications.

But the societies “strongly object” in their letter to the suggestion by CMS that participating registries must also include contemporaneous noninterventional controls followed on oral anticoagulants. “I would call that a clinical trial,” Kavinsky said. “It would be a burden to do that and would serve no purpose.”

Lastly, CMS advocates a formal shared decision-making interaction between patients and providers. The proposed decision memo refers to an “evidence-based decision tool” on anticoagulation.

“There is no such tool,” Kavinsky countered. “But what we have done is constructed a patient treatment algorithm that can be used to help teams decide how best to treat patients.” The algorithm and the full letter being sent to CMS on behalf of the 3 societies can be viewed on the SCAI website.

Requirements for Procedural Specialists

In March, after years of scrutiny, the FDA approved the Watchman device (Boston Scientific), to reduce the risk of thromboembolism from the LAA in patients with nonvalvular A-fib who are at increased risk for stroke and systemic embolism, are deemed by their physicians to be suitable for warfarin, and have an appropriate rationale to seek a nonpharmacologic alternative to warfarin. Over the summer, SCAI, ACC and HRS published a joint document highlighting the critical issues involved in appropriately integrating the Watchman and similar devices into clinical practice, noting that questions of who should perform the procedures and the type of institutional infrastructure needed were still in flux.

The new consensus document addresses proposed requirements, such as recommending that procedural specialists have a firm grasp of the underlying principles of A-fib, including medical management, rate and rhythm control, tools for assessing stroke risk, management of oral anticoagulant therapy, knowledge of available medications, an understanding bleeding risks, and knowledge of risks associated with LAA closure. Additionally, the writing committee recommends that physicians participating in these programs have a detailed understanding of the left atrium and LAA plus experience with procedures requiring access to the left side of the heart (ie, percutaneous left ventricular assist device placement, endovascular catheter ablation, pulmonary vein stenting). Its members also caution that performing LAA closure procedures “requires specific cognitive and technical skillsets and respect for the high-risk nature of these interventions.”

Specifically, the committee recommends that operators have 50 lifetime structural or left-sided catheter ablation procedures, at least 25 of which involved transseptal puncture through an intact septum. They also recommend that such operators maintain, over a 2-year period, 25 procedures involving transseptal puncture through an intact septum, 12 of which are LAA occlusion procedures.

With regard to institutional recommendations, the number of procedures is the same and must be maintained each year. Institutions also would be required to have continuous intraprocedure availability of a physician with experience at transesophageal echo in structural heart disease, and a multidisciplinary team that is involved from the preoperative evaluation through long-term follow-up. Additionally, these centers should have an active cardiothoracic surgery program with cardiac surgeons and perfusionists on-site as well as a cath lab, electrophysiology lab, or hybrid room with hemodynamic monitoring and high resolution imaging.

Source: 
Kavinsky CJ, Kusumoto FM, Bavry AA, et al. SCAI/ACC/HRS institutional and operator requirements for left atrial appendage occlusion. J Am Coll Cardiol. 2015;Epub ahead of print. 

Disclosures:

• Kavinsky reports no relevant conflicts of interest. 

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