"Very real complication" expected to rise as more HF patients are treated
It would be wrong to count out death as a risk of catheter ablation of atrial fibrillation (Afib), according to real-world data.
Early procedure-related mortality, occurring during index admission or readmission within 30 days after discharge, occurred in 0.46% of the 60,203 cases recorded in the Nationwide Readmissions Database in 2010-2015.
That rate "exceeds the rates of procedural death reported by other large studies examining Afib ablation outcomes," Jim Cheung, MD, of Weill Cornell Medical College in New York City, and colleagues reported in the Nov. 5 issue of the Journal of the American College of Cardiology.
"What is clear is that Afib ablation is not a benign procedure, and mortality is a very real complication of the procedure," the authors concluded. "It is also clear that experience matters. There is no doubt that the best outcomes are obtained at high-volume hospitals by high-volume operators."
Predictors of early mortality included:
- Low hospital case volume of fewer than 21 per year (aOR 2.35 vs high volume centers, 95% CI 1.33-4.15)
- Congestive heart failure (aOR 2.20, 95% CI 1.20-4.03)
- Procedural complications (adjusted OR 4.06, 95% CI 2.40-6.85)
"It should be emphasized that the benefits of Afib ablation for patients with CHF shown in recent clinical trials have largely involved high-volume academic centers, whose outcomes may not be replicated by lower-volume operators and centers in the real world," the researchers wrote. "Therefore, as more patients with CHF undergo Afib ablation, the rates of early mortality after the procedure may continue to rise on a national level."
A 2017 multi-society consensus statement recommends 50 Afib ablations for operators during fellowship and "at least several" per month thereafter to maintain competency.
"This study is an important and somewhat sobering addition to the literature on the safety of Afib ablation," according to an accompanying editorial by Hugh Calkins, MD, of the Johns Hopkins Hospital in Baltimore.
He wrote that his initial reaction to the study was that "the findings must be incorrect" -- he had never had a patient die as a result of Afib ablation over the past 20 years, and all the landmark trials reported no deaths.
"After a bit more reflection," however, Calkins said he was no longer surprised after recalling an earlier study in which investigators examined Afib ablations in the Nationwide Inpatient Sample and found a 0.46% rate of in-hospital mortality from 2000 to 2010 -- along with an association between annual low operator (or hospital) volumes and adverse outcomes.
Cheung's study covered the period from 2010 to 2015, which saw an increase in early post-ablation mortality (from 0.25% in Q1 2010 to 1.35% in Q3 2015, P<0.001) that tracked with rising comorbidity burden and rising age of people getting this procedure, according to Cheung and colleagues.
After adjustment, this trend of increased deaths was no longer significant, nor did the numerical rise of procedural complications reach significance (from 4.8% to 7.4%).
Of these deaths, 54.3% happened during readmission. Sepsis and congestive heart failure were the leading causes of readmission resulting in death after Afib ablation.
"[O]ur study provides real-world evidence that the rates of early mortality after Afib ablation are not insignificant and can occur in nearly 1 of 200 procedures," the authors noted.
The retrospective study relied on a database that lacked many relevant clinical variables and could have been subject to miscoding, the investigators acknowledged.
The study was supported by grants from the Michael Wolk Heart Foundation, the New York Cardiac Center, and the New York Weill Cornell Medical Center Alumni Council.
Cheung disclosed having received consulting fees from Abbott and Biotronik; and has received fellowship grant support from Abbott, Biosense Webster, Biotronik, Boston Scientific, and Medtronic.
Calkins is a consultant to and has received honoraria from Medtronic, Abbott Medical, Biosense, Boston Scientific, and AtriCure.
Journal of the American College of Cardiology
Source Reference: Cheng EP, et al "Risk of mortality following catheter ablation of atrial fibrillation" J Am Coll Cardiol 2019; DOI: 10.1016/j.jacc.2019.08.1036.
Journal of the American College of Cardiology
Source Reference: Calkins H "When it comes to the mortality rates of catheter ablation of atrial fibrillation, experience matters" J Am Coll Cardiol 2019; DOI: 10.1016/j.jacc.2019.09.005.
Read the original article on Medpage Today: Afib Ablation Deaths Do Happen