乌鸦传媒

Following pressure from medical societies, Centers for Medicare & Medicaid Services (CMS) eased some of the proposed restrictions for its final national coverage determination (NCD) on left atrial appendage (LAA) closure devices -- namely Boston Scientific's Watchman -- the agency .

Importantly, there is no longer a requirement for a medical treatment-alone control group in the LAA closure registry, launched in December 2015, in which patients must be enrolled if use is not part of a clinical trial.

The final determination cleared up confusion over its initially-stated limitation to patients contraindicated for warfarin (Coumadin), whereas FDA approval of Watchman was for patients able to take the anticoagulant.

The document said that LAA closure will covered for patients with "suitability for short-term warfarin but deemed unable to take long term oral anticoagulation following the conclusion of shared decision making, as LAAC is only covered as a second line therapy to oral anticoagulants."

The final criteria for reimbursement were more specific in defining risk, saying that patients eligible for coverage must have a CHADS2 score ≥ 2 or a CHA2DS2-VASc score ≥ 3, indicative of high stroke risk in the setting of atrial fibrillation (Afib).

Additionally, operator criteria were changed, requiring performance of at least 25 interventional cardiac procedures that involve transeptal puncture through an intact septum over 2 years.

The updates were made after the Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology (ACC), and the Heart Rhythm Society (HRS) published a statement recommending multiple changes to last year's original proposal.

“SCAI is pleased that CMS elected not to place extensive restrictions on patient access to this new therapy,” James Blankenship, MD, SCAI president, said in a statement from the society.

Following a decade of regulatory limbo, the Watchman finally received FDA approval in 2015, as questions of the device's efficacy and safety have been not been settled by the available randomized trials. Watchman demonstrated non-inferiority to warfarin but with more bleeding and other complications in the PROTECT-AF trial -- but, in the subsequent PREVAIL trial, failed to make par in terms of efficacy even as it met the safety and embolic protection endpoints.

Clinicians have argued that safety in randomized studies may not reflect real world outcomes, while proponents of the device have countered that LAA closure provides better stroke prevention -- for patients who might otherwise stop taking warfarin for a variety of reasons -- and is associated with less mortality.

Much of whether LAA closure gains traction will depend on data from the new registry, which may include devices such as SentreHeart's Lariat and St. Jude Medical's Amplatzer -- although not FDA approved for LAA closure -- in addition to Watchman.

Comment