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Operator experience not tied to outcomes after left atrial appendage occlusion
In a single-center study, there was no difference in outcomes after left atrial appendage occlusion according to operator volume.
The researchers analyzed 425 consecutive patients (mean age, 75 years; 59% men; mean CHA2DS2-VASc score, 4.5; mean HAS-BLED score, 3.9) with atrial fibrillation who underwent left atrial appendage (LAA) occlusion for stroke prevention between August 2015 and November 2018 performed by one of seven operators at Banner University Medical Center-Phoenix using an FDA-approved LAA occlusion device (Watchman, Boston Scientific).
Real-world data
“The purpose of the study was to reconcile three things,” Ashish Pershad, MD, interventional cardiologist at Banner – University Medicine Heart Institute Phoenix, told Healio. “No. 1, the complication rates and MACE rates for the Watchman procedure reported in the National Cardiovascular Data Registry (NCDR) concerned us. Due to the methodology, it appeared there was a high likelihood of underreporting. There was self-reporting which depended on the clinical specialists from the manufacturer of the device submitting case reports to ascertain if there was a complication. We came up with a large enough sample to estimate real-world complications. No. 2, for the debate over whether this was a procedure for electrophysiologists or interventional cardiologists, the pendulum swung according to hospital politics and dynamics. We didn’t think this should be a subspecialty-controlled procedure and wanted to see if there was a difference in outcomes by subspecialty. No. 3, previous work showed outcomes for transcatheter aortic valve replacement and transcatheter mitral valve repair varied by operator volume. This procedure is not as complex as those two, so we wanted to know if it fell into the same category of results dependent on operator volume.”
Patients were stratified by whether their procedure was performed by an operator with 40 or fewer cases per year, with 41 to 80 cases per year or with more than 80 cases per year.
The primary outcome was MACE, defined as death, stroke, bleeding and vascular complications. All patients were followed up at 45 days.
During the study period, 4.9% of patients experienced MACE; 0.5% died, 0.2% had a stroke, 0.9% had a major vascular complication and 4.2% had a major bleeding episode, according to the researchers.
“The complication rates for this procedure are almost 5%,” Pershad said. “That is almost double what was reported in the NCDR.”
No difference in MACE
After adjustment for age, hypertension, HF, diabetes, vascular disease, renal insufficiency, left atrial morphology, CHA2DS2-VASc score and HAS-BLED score, there was no difference between the three volume groups in MACE (OR = 0.59; 95% CI, 0.15-2.29), Pershad and colleagues wrote.
“One thing that was very clear is that this procedure does not have volume-based outcomes,” Pershad said in an interview. “Even doctors who perform this procedure infrequently can do it well if they have the right skill set: good imaging and transseptal puncture technique.”
There was also no difference between the groups in MACE according to whether the operator was an interventional cardiologist or electrophysiologist (OR = 0.6; 95% CI, 0.21-1.68), according to the researchers.
“Specialty doesn’t matter,” Pershad said. “Interventional cardiologists do it as well as the [electrophysiologists].”
Technical success was high and did not differ by operator volume (OR = 1.87; 95% CI, 0.47-7.48) or operator specialty (OR = 0.59; 95% CI, 0.21-1.63), the researchers found.
To account for the initial learning curve, the researchers performed a separate analysis in which each operator’s first 10 cases were excluded. The results did not change.
The findings “could allow for controlled expansion of the procedure,” Pershad said in an interview. “The dissemination of LAA occlusion can be more widespread because there are so many patients that currently have an unmet clinical need that are not able to be treated because they are not near a major medical center. This type of information can help disperse the procedure to community centers.” – by Erik Swain
For more information:
Ashish Pershad, MD, can be reached at 755 E. McDowell Road, Floor 4, Phoenix, AZ 85006; email: ashish.pershad@bannerhealth.com.
Disclosures: The authors report no relevant financial disclosures.