Medicare claims show no increase in major adverse outcomes
Hospitals performing atrial fibrillation (Afib) ablations without an on-site cardiothoracic surgery department showed no safety disadvantage in a retrospective study, although a practitioner told MedPage Today he remained unpersuaded.
Medicare records from 2013-2016 showed that the incidence of cardiac perforation within 30 days was 0.67% and was not commonly followed by cardiothoracic surgery (1.08%) or death (3.4%) when perforation occurred, according to the group led by Daniel Friedman, MD, of Duke Clinical Research Institute in Durham, North Carolina, in the May 21 issue of the Journal of the American College of Cardiology.
Notably, the 14% of U.S. centers without surgeons on-site to perform backup repairs for cardiac perforations did not have higher rates of cardiac perforation, pericardiocentesis, all-cause death, or 30-day rehospitalization after Afib ablation, per propensity-matched analyses comparing these hospitals with the majority that did have this resource. Raw data on the overall cohort, however, indicated higher 30-day mortality among patients treated at hospitals without the surgical backup (0.89% vs 0.43%, P=0.01).
On the other hand, all deaths after perforation occurred in patients who had been ablated at hospitals with emergency surgical backup.
Further study is warranted to confirm whether it's reasonable to perform these procedures in carefully selected patients in hospitals without on-site cardiothoracic surgery, the investigators cautioned.
But Wilber Su, MD, of Banner-University Medical Center Phoenix in Arizona, remained skeptical that safety doesn't require availability of surgical backup.
"I can also run across the freeway blindfolded at 2 a.m. and likely not get in trouble, but it doesn't mean it's a good idea," he argued in an email to MedPage Today. "But as technology improves, complications will [be reduced]. We are simply not at a point where we should ignore these complications."
Although perforations requiring surgical intervention may be "low-incidence," he said, emergency surgery can prevent death when they do occur. Su added that there is no reason to try Afib ablation in hospitals without surgical backup, since there are plenty of hospitals that come with it.
For the study, Friedman and colleagues analyzed outcomes of just under 70,000 Medicare patients ages 65 years and older who had an Afib ablation at one of more than 1,000 hospitals. Centers were said to have cardiothoracic surgery available if they filed at least one claim for coronary artery bypass grafting during the study period.
Hospitals with no such claims accounted for only 2% of ablations. Compared with hospitals that did perform cardiothoracic surgery, their patients were more likely to be older and female, and have a higher comorbidity burden and stroke risk.
The study authors acknowledged that their retrospective review of administrative claims meant that residual confounding was possible despite their efforts in propensity matching. Moreover, the results may not be generalizable to younger patients or those with other insurance, they said.
"This is simply a retrospective review, and may not encompass real-life and all-encompassing, [so] simply a very limited conclusion can be drawn," Su emphasized.
"I have done literally thousands of cryoballoon Afib ablations without a major complication in years, but I wouldn't do it in a hospital without surgical backup. In seeing [the] complications that get transferred to us for surgical repair, it is definitely not a good idea now," he said.
A multi-society 2017 expert consensus statement on Afib ablation does not mandate surgical backup, but recommends it.
The study was funded by Johnson & Johnson.
Friedman disclosed that he received salary support from the NIH; research support from the National Cardiovascular Data Registry, Boston Scientific, Biosense Webster, and Abbott; and educational grants from Boston Scientific, Medtronic, Abbott, and Biotronik.
Journal of the American College of Cardiology
Source Reference: Friedman DJ, et al "Catheter ablation of atrial fibrillation with and without on-site cardiothoracic surgery" J Am Coll Cardiol 2019; DOI: 10.1016/j.jacc.2019.02.036.
Read the original article on Medpage Today: Afib Ablation Sans Surgical Backup Said to be OK, But Doubts Linger