Biventricular stimulation to prevent cardiac desynchronization: rationale, design, and endpoints of the ‘Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization (BioPace)’ study

Abstract

Despite the deleterious effects of cardiac dyssynchrony and the positive effects of cardiac resynchronization therapy, patients with high-degree atrioventricular block continue to receive desynchronizing right ventricular (RV) pacing systems. Although it is unclear whether the negative effects of RV pacing and left bundle branch block (LBBB) are comparable, and whether they depend on the presence and the degree of structural heart disease, one may hypothesize that RV pacing may have similar effects to LBBB. In the BioPace trial, the long-term effects of RV pacing vs. biventricular pacing will be prospectively compared in 1200 pacemaker patients with high likelihood of mostly paced ventricular events, regardless of whether in sinus rhythm or in atrial fibrillation (AF). After echocardiographic examination of left ventricular (LV) function, patients will be randomly assigned to the implantation of an RV vs. a biventricular pacing system and followed for up to 5 years. Primary study endpoints are survival, quality of life (QoL), and the distance covered in a 6-min hall walk (6-MHW) at 24 months after implantation. Secondary endpoints are QoL and the 6-MHW result at 12 months after implantation, hospitalization rate, LV dimensions, LV ejection fraction, and the development of chronic AF and other adverse events.

Incidence and Time Course for Developing Heart Failure With High-Burden Right Ventricular Pacing

“…7,8,11,12 The inclusion of outpatient encounters in assessing the adverse impact of chronic RV pacing is particularly relevant given estimates that physician visits for HF account for ≈2% of all outpatient office visits and cost the healthcare system >$2 billion per year in the United States, representing an important opportunity for curbing healthcare expenditures. 27 Although it has been suggested that all patients undergoing pacemaker implantation with a predicted high burden of RV pacing should be implanted with a biventricular device, 7 the results of the PREVENT-HF study 28 and the preliminary results of the BioPace study 25,29 suggest that such a broad approach to biventricular pacing may not be justified. In general, patients with PICM seem to benefit from upgrade to biventricular pacing.…”

Should All Patients With Heart Block Receive Biventricular Pacing?

“…36 The main criticism of this trial was small sample size (n=108 with ventricular pacing percentages ≥80%) and high crossover rate from biventricular to RV pacing. 42 The preliminary results of the larger (n=1,810) Biventricular pacing for Atrioventricular Block to prevent Cardiac Desynchronization (BIopACE) study 43 were released at the annual meeting of the European Society of Cardiology in 2014. The composite end point of death or first HF hospitalization was similar between biventricular and RV pacing …”

Patients with long-term permanent pacemakers have a high prevalence of left ventricular dysfunction

“…[40] One large randomised study looking at the effects on morbidity and mortality of CRT versus RV pacemaker systems in patients with a bradycardia has completed recruitment. [41] Although there is growing enthusiasm for right ventricular septal pacing there are as yet no hard endpoint data to support widespread adoption of this strategy. [42][36]…”