Months after the U.S. Food and Drug Administration (FDA) approved a device with the potential to close the source of many atrial fibrillation-related strokes, hospitals, cardiologists and patients find themselves in a holding pattern increasingly common for newly emerging therapies: They are waiting for the Centers for Medicare & Medicaid Services (CMS) to issue a national coverage determination for left atrial appendage (LAA) occlusion.
As many as 6.1 million Americans are living with atrial fibrillation (afib) and the concomitant high risk for stroke. While anticoagulant medications are a proven and viable option for reducing stroke risk faced by most of these patients, about 40 percent can’t or won’t take warfarin or one of the newer oral anticoagulants (JAMA 2014;312:1988-1998). The medications prevent blood from clotting and causing ischemic stroke, but they also raise the risk for intracranial hemorrhaging and gastrointestinal bleeding.
Factor in the potential for bleeding complications and the challenge of regular blood tests required to monitor the effects of warfarin, and the circumstances are ripe for “a technology that doesn’t require that patient to be on a blood thinner long term,” says Kevin Wheelan, MD, chief of staff at Baylor University Medical Center’s Heart and Vascular Hospital in Dallas.
Enter LAA occlusion, a treatment strategy aimed at sealing off the small sac that sits on the heart’s upper left chamber. The LAA has been found to be the source of the blood clots that cause many of the strokes suffered by afib patients.
“We know that of patients who present with a stroke and have afib, about 75 to 85 percent can be demonstrated to have a clot in the left atrial appendage,” Wheelan says.
Eliminating the source of clots is the idea behind the Watchman Left Atrial Appendage Closure Device (Boston Scientific). A physician—typically an electrophysiologist or interventional cardiologist—delivers the device percutaneously. Starting from a femoral access site, the physician delivers the device through the heart’s septum to the mouth of the LAA. Once in place, the quarter-size Watchman is unfurled and implanted snugly to close off the LAA, thereby preventing blood from entering the LAA, where it could coagulate and generate clots that embolize to the brain.
Watchman was a long time coming. It was evaluated in two clinical trials and two registries encompassing more than 2,400 patients and 6,000 patient-years. It took three FDA advisory panels before the device was approved for use in the United States. The FDA indication specifies Watchman is for afib patients who are at risk for stroke and eligible to take anticoagulants, and have a need for an alternative to anticoagulants to reduce their stroke risk. The device will enter a market where cardiologists have been using the Lariat Suture Delivery Device (SentreHeart) on an off-label basis to seal off the LAA in afib patients.
The questions in play now that Watchman has been FDA-approved, say cardiologists, are which patients should undergo LAA occlusion and how long they will have to wait.
Answers will come when CMS unveils an NCD, expected in February 2016. In the interim, hints about the NCD arrived on Nov. 10, when CMS issued a proposed decision memo suggesting the NCD might limit coverage only to patients who are at high risk for stroke and bleeding and have a “contraindication to warfarin” (www.cms.gov, 2015). These requirements were among seven criteria outlined by CMS, with others focused on institutional and operator requirements, physician training and proctoring, registry enrollment and use of clinical decision support tools. CMS’s memo triggered a 30-day open comment period during which professional societies, physicians and others could provide feedback to help inform the final NCD.
“Remember, this is only a proposal,” says Clifford Kavinsky, MD, PhD, director of the Rush Center for Adult Structural Heart Disease at Rush University Medical Center in Chicago, and lead author of the Society for Cardiovascular Angiography and Interventions (SCAI)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) expert consensus document on institutional and operator requirements for LAA occlusion (Catheter Cardiovasc Interv online Dec 10, 2015).
“We’d like to see the NCD be much more precise and granular than what the proposal includes, specifically with regard to patient selection, the definition of ‘high risk,’ and ‘contraindication to warfarin’ as well as the operator and institutional requirements,” Kavinsky says. “The goal is to achieve a controlled roll-out that doesn’t leave the door open to unbridled use of the procedure.”
In their response to CMS’s proposed decision memo, the societies advised CMS to allow LAA occlusion for patients with high risk scores for stroke and either a high risk score for bleeding or a contraindication to anticoagulation.
Why the wait?
The period between FDA approval and reimbursement announcements has become challenging for providers and hospitals. Investigational therapies are covered during clinical trials, but once the trials close and after the FDA grants approval, the waiting starts. There’s no guarantee CMS’s coverage policy will be broad enough or the fees high enough for hospitals to profit from the procedure, or maybe even to cover their costs.
Though more than 2,400 patients received a device during the Watchman trials, now some hospitals are reluctant to commit to the procedure until they know the fees CMS will assign to it.
“Reimbursement has a significant impact on the utilization of this technology,” Wheelan says. “Under the current structure for Medicare patients, which is the largest pool of individuals who could benefit from [LAA occlusion] technology, the cost to purchase the product [exceeds] the entire payment from Medicare for buying the product and installing it. Under the best of circumstances, a hospital loses money on every single patient in whom they implant one of these devices.”
Like Wheelan, Brian Whisenant, MD, medical director for the structural heart disease program at Intermountain Medical Center in Murray, Utah, was part of the original multicenter clinical trials to evaluate Watchman. He, too, is keen to see Medicare’s final coverage decision.
Until CMS publishes its NCD, reimbursement policy is left to the discretion of the country’s seven regional Medicare administrative contractors, some of whom have non-coverage policies in effect for LAA closure devices, according to Whisenant.
It’s a dilemma for all of today’s emerging technologies, says Wheelan. “No one wants to pay for the benefits of advancing technology and better health that can come from creating new solutions to disease problems. Ultimately, it’s an expensive process and there has to be adequate reimbursement at the end or you dramatically limit the number of patients who are referred for this type of treatment.”
Striding forward. Slowly.
While they wait, hospitals are evaluating the value proposition for LAA occlusion, including whether the payments will be high enough to offset the costs of offering the procedure. In addition to the price of the devices themselves, hospitals that intend to offer LAA occlusion need to allocate resources, train physicians and staff, and enroll in national data registries, among other costs.
In the face of the uncertainty and expense, hospitals are taking different approaches whilst they await news from CMS.
“Our hospital has adopted a conservative stance,” Whisenant says. “We approached them and said this is an unmet need. We need to take care of patients. … They said go ahead and do a few procedures and let’s see what happens with reimbursement. They have allowed us to do some procedures, pending visibility on the national coverage decision while providing full disclosure to Medicare. We have a large number of patients who are waiting for a procedure at this time.”
Kavinsky says that until recently his hospital was in a holding pattern while they awaited the NCD and negotiated with the manufacturer on device prices.
“If there are places that are using the Watchman device, they may be doing it at a loss,” he says.
Because the process of becoming an LAA occlusion center takes time, Northeast Georgia Health System and Medical Center, is moving forward one case at a time, according to electrophysiologist Alok Gambhir, MD, PhD.
Gambhir began performing LAA procedures with the Lariat Suture Delivery Device in October 2015. Though he had already been trained to perform LAA occlusion, it still took more than a year to complete the work necessary to offer LAA occlusion.
“It takes a lot of training and commitment before you can even perform the procedure … training staff, taking up resources for the new procedure that were not set up yet. The anesthesiologists have to be trained regarding the procedure as well as someone to do a transesophageal echocardiogram from the correct angle,” Gambhir says.
Assembling and training the LAA occlusion team is a key part of preparation, physicians agree. There’s no single formulation that will be ideal for every center.
Collaboration is essential, according to a “societal overview” of LAA occlusion published by ACC, HRS and SCAI that states: “The multidisciplinary heart team must work together, particularly with respect to patient evaluation and selection, pre-procedural evaluation, intra-procedural management, post-procedural management, post-discharge follow-up, and outcome analysis” (J Am Coll Cardiol 2015;66:1497-1513).
“[The team] may consist of an electrophysiologist or a structural heart disease physician, a surgeon, an echocardiographer,” Kavinsky says. “There should be advanced nurse practitioners. All of them working together to make sure that this procedure, when it’s done, is done safely and effectively. An institutional multistakeholder process for patient selection, outcomes analysis and quality should be in place.”
Whether an electrophysiologist or an interventional cardiologist will lead the team is likely to differ by facility. Whisenant, an interventionalist, says the Intermountain model has evolved into a partnership between him and electrophysiologist Peter Weiss, MD.
“Noninvasive cardiologists, interventional cardiologists and electrophysiologists all have important roles to play in the management of atrial fibrillation. Ideally we work together to consider a variety of options tailored to each individual patient. These options include medical therapy and ablation in addition to left atrial appendage closure,” Whisenant says. “Both interventional cardiologists as well as electrophysiologists are well-suited to closing the left atrial appendage if they prioritize this as a focus of their practice.”
At Intermountain, the LAA occlusion team relies on the same technologists, nurses, imagers and physicians as with other left-heart procedures. “The difference is that there can be other physicians who specialize in structural heart disease who technically have the expertise to do transseptal left heart catheterization,” he explains.
Collaboration between interventional cardiology and electrophysiology may become the model at some hospitals; however, some hospitals are choosing one of the two specialties to lead the LAA occlusion team.
“The implant of an LAA occlusion device requires the cooperation of a team with anesthesia, and an echocardiography expert who performs a transesophageal echo while the procedure is being done to assist in device size and selection and confirm good placement,” Wheelan says.
There’s an important role for the cardiac surgeons on the team as well, according to Gambhir. “If a complication happens, it’s usually a more serious one. With the LAA closure, and Lariat specifically, when you’re closing off the LAA, it could rupture and it could become a surgical emergency. …We let the cardiothoracic surgeons know that we are doing this case today so they’re physically around and we can call them.”
Some institutions, including his, are performing LAA occlusions in the hybrid operating room to improve response times if surgical intervention is required.
On the horizon
While Watchman is currently the only device in the United States with an indication for LAA occlusion, some cardiologists expect it’s a temporary situation and the devices they have to choose from will expand before long. In Europe, CE Mark status for LAA occlusion has been granted to the Amplatzer Cardiac Plug and Amulet devices (St. Jude Medical), AtriClip (AtriCure), Coherex WaveCrest (Coherex Medical), Figulla Flex II (Occlutech), Lariat and Watchman.
Whisenant, who disclosed that he is a director and stockholder of Coherex Medical, predicts several randomized, device-versus-device comparisons will ramp up in 2016 as various companies lay the groundwork for FDA approval. For example, patient enrollment is set to start for the aMAZE study, which will evaluate the safety and effectiveness of the Lariat system to percutaneously isolate and ligate the LAA from the left atrium as an adjunct to pulmonary vein isolation catheter ablation.
“There is a need in the community for these procedures,” Gambhir says. “These patients will have a stroke because they’re not on anticoagulation and are at high risk for stroke because of atrial fibrillation. The question is whether delaying the cost is worth the wait for patients with the highest risk for stroke.”