Reducing the Rate of Serious Adverse Events in the Cardiac Electrophysiology Laboratory From 2% to 1%

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EP LAB DIGEST. 2024;24(8):6.

Dear Readers,

There are 2 goals when performing procedures in the cardiac electrophysiology (EP) laboratory: safety and efficacy. What is the actual risk associated with an EP procedure in 2024? A meta-analysis from 2023 looked at the rate of complications related to ablation for atrial fibrillation (AF). The study included >15,000 patients undergoing a first ablation procedure for AF from 89 randomized trials and found that the rate of overall procedure-related complications was 4.5% with an incidence of severe complications of 2.4%.¹ Notably, a 30% reduction in the complication rate was observed from the earlier period (2013-2017) to the more recent period (2018-2002). If one looks at recent large clinical trial data from high-volume centers by experienced operators, the risks now seem very low. The just-published ADVENT trial is a good example of a modern ablation trial.² Over 600 patients were randomized to thermal ablation (using radiofrequency or cryoenergy) versus pulsed field ablation (PFA). Consistent with most clinical trials, an adverse event was defined by an adjudication committee as being serious when the event was life-threatening or resulted in death, hospitalization, prolongation of hospitalization, persistent impairment, or a corrective intervention. In this study, the incidence of a serious adverse event was low at 2.0% in the PFA group and 1.3% in the thermal group. In general, the rate of major complications from a catheter ablation procedure for AF appears to range from 4% to 13%, with higher volume centers and busier operators having lower rates of complications.3 In one meta-analysis, the odds ratio for adverse events was significantly lower in more experienced centers at 0.62.³

But what does it take to reduce the rate of complications in the EP laboratory from 2% to 1%? First, it requires experience, attention, and expertise

by the electrophysiologist performing the procedure. Second, it requires a culture in which patient safety in the EP laboratory is the top priority. Third, it requires periodic, regular, systematic reviews/quality meetings during which the entire heart rhythm team reviews the rate and types of complications that are occurring in the EP laboratory. Whether a center participates in a multicenter program such as the American Heart Association’s Get With The Guidelines registry, or simply holds periodic quality meetings during which every major complication is reviewed, it is critical to examine each case to identify trends and to determine if techniques, tools, personnel, team members, infrastructure, hospital support, or approaches should be modified to improve outcomes. Fourth, one must recognize that it takes substantially more effort and attention to detail to reduce the rate of complications from 2% to 1% than it does to reduce the rate from 4% to 3% (Figure). 

The inverse is also true. It can take a substantial reduction of effort at a high-volume center that is already operating at very safe levels for the rate of complications to rise to a higher level that is noticed. This has important implications for hospitals making major changes in how care is delivered in their system. For example, when a hospital system centralizes all their regional cardiac care to a single hospital and begins to transfer patients from the emergency departments of their spoke hospitals to the centralized hub hospital, there will inherently be a delay in the care of some critically ill patients. This will inevitably result in a few bad outcomes, even if these are balanced by better overall system outcomes. But will an increase in serious adverse events from 1% to 2% at the spoke hospitals set off any alarms? 

As one might say to the incoming trainees for this academic year, many electrophysiologists can successfully perform catheter ablations and device implantations on patients with heart rhythm disorders, but it is their educational mission to learn not just how to do the procedure, but how to do the procedure without a complication. Of course, it is unrealistic to expect zero complications from an invasive procedure, but that should be the goal. It is also important to learn that trying to lower the rate of serious adverse events from 2% to 1% in the EP laboratory can require much more than twice the effort. 

Disclosures: Dr Knight has served as a paid consultant to Medtronic and was an investigator in the PULSED AF trial. In addition, he has served as a consultant, speaker, investigator, and/or has received EP fellowship grant support from Abbott, AltaThera, AtriCure, Baylis Medical, Biosense Webster, Biotronik, Boston Scientific, CVRx, Philips, and Sanofi; he has no equity or ownership in any of these companies.

References

1. Benali K, Khairy P, Hammache N, et al. Procedure-related complications of catheter ablation for atrial fibrillation. J Am Coll Cardiol. 2023;81(21):2089-2099. doi:10.1016/j.jacc.2023.03.418

2. Reddy VY, Gerstenfeld EP, Natale A, et al. Pulsed field or conventional thermal ablation for paroxysmal atrial fibrillation. N Engl J Med. 2023;389(18):1660-1671. doi:10.1056/NEJMoa2307291

3. Tonchev IR, Chi Yuan Nam M, Gorelik A, et al. Relationship between procedural volume and complication rates for catheter ablation of atrial fibrillation: a systematic review and meta-analysis. EP Europace. 2021;23(7):1024-1032. doi:10.1093/europace/euaa415