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Permanent His bundle pacing feasible, safe in patients requiring pacemakers
ORLANDO, Fla. — In a new study, permanent His bundle pacing was feasible and safe, compared with conventional right ventricular pacing, in a real-world population of patients requiring a permanent pacemaker for bradycardia.
During a mean follow-up of about 2 years, the primary outcome — a composite of death, hospitalization due to HF or upgrade to biventricular pacing — occurred in 220 of 765 patients included in the study. Risk for the primary outcome was significantly lower among patients assigned to His bundle pacing vs. those assigned right ventricular pacing (25% vs. 31.6%; HR = 0.71; 95% CI, 0.53-0.94). The effect was more pronounced in patients with a ventricular pacing burden greater than 20% (25.3% vs. 35.6%; HR = 0.65; 95% CI, 0.46-0.93) compared with those with a pacing burden less than 20% (22% vs. 23.7%; HR = 0.78; 95% CI, 0.47-1.3).
The nonrandomized, observational cohort study evaluated and compared data from patients requiring new permanent pacemakers who received His bundle pacing or RV pacing at two hospitals within the Geisinger Health System from October 2013 to December 2016. Of 765 patients enrolled, 332 underwent attempted His bundle pacing (mean age, 75 years; 60% men) and 433 underwent RV pacing (mean age, 76 years; 52% men).
Comparison of two strategies
Mean procedure time was about 15 minutes longer and fluoroscopy time 3 times longer in the His bundle pacing group.
In terms of secondary outcomes, the incidence of HF hospitalization was significantly lower in the His bundle pacing group vs. the RV pacing group (12.4% vs. 17.6%; HR = 0.63; 95% CI, 0.43-0.93). Again, the findings were primarily seen in patients with a ventricular pacing burden greater than 20% (12.4% vs. 20.1%; HR = 0.54; 95% CI, 0.33-0.88) vs. lower than 20% (13% vs. 13.2%; HR = 0.88; 95% CI, 0.45-1.69).
The researchers reported a trend toward decreased all-cause mortality with His bundle pacing vs. RV pacing, but it did not reach statistical significance, Mohamed Abdelrahman, MD, from the Geisinger Heart Institute in Wilkes-Barre, Pennsylvania, said during a presentation of the data at the American College of Cardiology Scientific Session.
Upgrade to biventricular pacing occurred in one patient in the His bundle pacing group, as compared with six patients in the RV pacing group.
Baseline characteristics were mostly similar between the two study arms. However, the His bundle pacing group included more men, more patients with a history of atrial fibrillation and more beta-blocker usage.
‘More of a niche procedure’
This study addresses “the clinical need to determine the best possible ventricular pacing site in patients requiring permanent pacemakers for bradycardia therapy,” the researchers wrote in the Journal of the American College of Cardiology.
“Chronic right ventricular pacing is associated with increased risk of left ventricular dysfunction secondary to electrical and mechanical dyssynchrony,” Abdelrahman said during a presentation. “His bundle pacing depolarizes the ventricles via the His-Purkinje system, inducing a normal synchronous ventricular activation, thus preventing ventricular dyssynchrony.”
Abdelrahman noted that the study was limited by its nonrandomized design and the potential for selection bias secondary to location and the clinical practice of the treating hospital. Furthermore, a majority of His bundle pacing cases were performed by electrophysiologists with extensive experience with the procedure.
Pugazhendi Vijayaraman, MD, study author, associate professor of medicine at Geisinger Commonwealth School of Medicine and director of electrophysiology at the Geisinger Heart Institute, said these data confirm the benefits of His bundle pacing observed in smaller studies in a large, real-world population with long-term follow-up.
“For a long time, His bundle pacing has been more of a niche procedure that hadn’t gained traction because it is considered to be difficult and challenging. Additionally, previously reported outcomes weren’t optimal,” Vijayaraman told Cardiology Today. “One of the main messages of this study is that His bundle pacing should be attempted in any patient who needs ventricular pacing and it can be done in routine clinical practice.”
However, education is important.
“Because it’s a slightly different type of procedure compared with the regular pacemaker in terms of skill set, there is a learning curve, so it is important that new implanters learn those skills,” he said.
The researchers emphasized that the findings need to be confirmed in multicenter, randomized, controlled trials, one of which is in the works, Vijayaraman noted. – by Melissa Foster
References:
Abdelrahman M. Featured Clinical Research I. Presented at: American College of Cardiology Scientific Session; March 10-12, 2018; Orlando, Fla.
Abdelrahman M, et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.02.048
Disclosures: Vijayaraman reports he is a speaker and consultant and has received research grants from Medtronic; he is a consultant for Boston Scientific and Abbott; and he has a patent pending for a His delivery tool. Abdelrahman reports no relevant financial disclosures.