John Mandrola, MD

Disclosures

June 09, 2016

On the first day of the 2016 CardioStim sessions, I am happy to report a "positive" study on percutaneous left atrial appendage closure[1].

Notice I did not write Watchman. In Europe, the majority of physicians I spoke with close the left atrial appendage with the St Jude Medical Amplatzer Amulet device—which is not FDA-approved in the US.

The European Heart Rhythm Association (EHRA) EUROPACE-CARDIOSTIM 2016 meeting poster presentation I will tell you about is unique in that it reports not only the outcomes of the procedure, but also the process of deciding who gets the device.

Stefano Bartoletti and colleagues from the Liverpool Heat and Chest Hospital, UK (senior researcher Dihraj Gupta) set out to assess the impact of a process called "commissioning through evaluation" (CTE)

By email, Gupta explained that CTE is a project that NHS England put into place in 2014 for procedures that it does not routinely reimburse but that (according to the website) "show significant promise for the future, while new clinical and patient-experience data are collected within a formal evaluation program." These include left atrial appendage occlusion (LAAO), patent foramen ovale (PFO) closure for cryptogenic stroke, and Mitraclip for mitral regurgitation.

The CTE process for appendage closure was meant to allow commissioning for a limited number of these procedures (30 per year per center for 3 years) in 10 high-volume cardiac centers in the UK.

The conditions of funding were a promise of careful selection of patients through a multidisciplinary team process and real-time upload of procedural and follow-up data to the National Institute for Cardiovascular Outcomes Research (NICOR) NHS website. Then the National Institute for Health and Care Excellence (NICE) would review the CTE data at the end of the 3-year period and decide whether it is a cost-effective intervention for the NHS to fund routinely.

To comply with these CTE requirements, the Liverpool clinician researchers developed a multidisciplinary team that included stroke physicians, noninvasive cardiologists, and proceduralists. Another strategy they used was to allow only two operators, one of them being an experienced electrophysiologist. Gupta said this was a big change from the earlier UK experience, when the procedure was done mostly by non-EP interventionists.

Results

Their study population included 77 patients referred to the multidisciplinary team. The cohort was a typical high-risk group—average age 76 years and a mean CHA2DS2-VASc of 4. The indications for appendage closure included intracranial bleeding (55%), GI bleeding (19%), and other disorders such as severe epistaxis, cerebral amyloid angiopathy, or CNS AV malformation (26%).

Of the 77 patients referred, only 53 (69%) patients were offered the procedure, and 42 actually had the procedure. Reasons patients were not offered the procedure included inappropriate referral (5%), some were maintained on watchful waiting (5%) or required more tests (4%), while others were put on direct acting oral anticoagulant drugs (17%).

The implant procedure was successful in all 42 cases. Bleeding requiring transfusion occurred in two patients. By email, Gupta said that since the abstract was written in January, they have done 60 cases—with a 100% success rate and no additional complications.

They discharged patients on a 6-week course of dual antiplatelet therapy followed by single antiplatelet therapy.

Clinical outcomes (n=36) at a median follow-up of 122 days: one patient had a stroke at 12 months, three patients had bleeding events, and one patient with severe hypertrophic cardiomyopathy died suddenly 3 weeks after the procedure.

Imaging outcome at 6 to 8 weeks (n=32) showed that 87% of patients had no residual leak and 12% of patients had a small (<5 mm) residual leak.

The authors concluded that commissioning through evaluation has changed their practice in their hospital. Careful patient selection resulted in high procedural success and low complications.

My Comments

This abstract stood out because it supports both innovation and cautious patient care.

I've been negative on Watchman—how else should we see a device that failed both noninferior efficacy end points in a well-performed clinical trial?

But I'm not against innovation. We need something to offer high-risk patients who are truly ineligible for anticoagulation. Appendage closure may help this group. We don't know because they were excluded from the trials.

In the interim, the Liverpool process of careful screening, limiting the number of operators, and meticulous data collection increases the chances we will know whether appendage closure improves outcomes.

Compare this process with another strategy: patients referred for the procedure get the procedure, and few data are collected. Appendage closure has been done in Europe for a decade or more—imagine the information we would have if processes like these were in place from the beginning.

It gets me in trouble with some to say positive things about restrictive national coverage decisions from government payers.

But in the case of allowing access to uncertain and expensive technology, the mandate to slow down and collect data seems the best way to reduce health inequities in health services and health outcomes.

JMM

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