A trio of professional societies has issued consensus recommendations for the use of left atrial appendage closure devices recommendations that argue against several significant restrictions in proposed rules from the Centers for Medicare and Medicaid Services.
A trio of professional societies has issued consensus recommendations for the use of left atrial appendage closure devices — recommendations that argue against several significant restrictions in proposed rules from the Centers for Medicare and Medicaid Services (CMS).
CMS has announced plans to stop paying for routine treatment with the only appendage closure device available to patients with atrial fibrillation (AF), a tool called the Watchman, on grounds that studies to date haven’t demonstrated it to be “reasonable and necessary to diagnose or treat an illness or injury or to improve the functioning of a malformed body member.”
However, CMS is proposing to cover procedures that are specifically designed to produce more evidence about the device’s efficacy (or lack thereof) — if and only if those procedures meet 7 conditions. Key provisions of the proposed rules state that patients must have non-valvular AF, a high risk of both stroke and bleeding and a contraindication to warfarin, that procedures must take place in hospitals with particular technology and personnel and that surgeons must have particular credentials and experience (including training from a surgeon who has used the device but has no ties to its manufacturer and receives no money to provide training).
The rules also mandate follow-up designed to track outcomes for all patients and follow-up on a control group of patients who do not undergo left atrial appendage closure.
“The registry must be designed to permit identification and analysis of patient, practitioner and facility level factors that predict patient risk for these outcomes. The registry must include contemporaneous patients followed on oral anticoagulant (OAC) therapy to serve as non-interventional controls. CMS will review the qualifications of candidate registries to ensure that the approved registry follows standard data collection practices and collects data necessary to evaluate the patient outcomes specified above.”
Many of these conditions are echoed in joint recommendations just issued by The Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology (ACC), and the Heart Rhythm Society (HRS). For example, the document, which is published in journals from all societies, agrees on the need for a national registry that collects outcome data on all patients and thus furnishes more evidence on device performance.
The joint recommendations do differ substantially from the CMS proposal, though, both in their general spirit and in a number of important recommendations. For example, the joint recommendations begin by describing left atrial appendage closure not as an unproven strategy but as “an important addition to the physician’s armamentarium to help mitigate [ischemic stroke in AF patients.]” They go on to argue that left atrial appendage closure should generally be covered by insurance, so long as it is performed by well-qualified doctors on the proper patients, in the proper settings and with the proper follow-up.
The joint recommendations also disagree with the CMS proposal on what constitutes proper patients, proper doctor training and proper study of long-term outcomes. Those disagreements are even more explicit in a letter (link to download letter at the bottom) that the heads of the 3 professional societies sent to CMS in response to its proposed rules.
One patient selection: “The draft policy, as written, requires patients to have a high CHADS2 or CHA2DS2-VASc score, high HASBLED score, AND contraindication to warfarin… More consistent with the FDA indications, the societies strongly recommend qualifying patients who have a high CHADS2 or CHA2DS2-VASc score AND EITHER a high HAS-BLED score OR a contraindication to warfarin.”
On proctors who train doctors to perform procedures: “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.”
The professional societies objected even more vigorously to the idea of using the registry to compare outcomes for real-world patients who do and don’t undergo appendage closure.
“For this population, the term ‘control’ is inaccurate. The ‘non-interventional controls’ would in fact represent a widely mismatched group that should not be comparable to patients who receive the device. The societies strongly object to this requirement and recommend its deletion… While the desire to obtain information on a control group undergoing oral anticoagulation is understandable, that has been the subject of two well conducted trials that randomized patients, using a model and scientific rigor that could not remotely be replicated with the proposed control arm.
“Moreover, such a control arm would require that every institution performing [left atrial appendage closure] set up an elaborate screening process, obtain investigational review board approval, and seek informed consent from patients and follow up from patients, most of whom may be seen entirely in an outpatient setting by a myriad of clinicians few of whom will have any involvement with [left atrial appendage closure.]”