Biventricular Pacing After Ablate Compared With Right Ventricular Therapy - PAVE

Description:

The goal of the trial was to evaluate biventricular (BV) pacing compared with permanent right ventricular (RV) pacing in patients with chronic atrial fibrillation (AF) refractory to pharmaceutical therapy undergoing ablate and pace therapy.

Study Design

Patients Enrolled: 252
Mean Follow Up: Six months
Mean Patient Age: Mean age 68 years
Female: 35
Mean Ejection Fraction: Mean baseline ejection fraction 46%

Patient Populations:

Chronic atrial fibrillation, elective AV nodal ablation procedure, and permanent pacemaker; New York Heart Association (NYHA) class I-III; six-minute walk test <450 m; and stable cardiovascular medication

Exclusions:

NYHA class IV, >450 m on six-minute walk test, implantable cardioverter defibrillator (ICD) or consideration for ICD or coronary artery bypass grafting, or prosthetic valve replacement

Primary Endpoints:

Exercise capacity, as assessed by six-minute walk test

Secondary Endpoints:

VO2 max and quality of life, as assessed by SF-36 Health Survey

Drug/Procedures Used:

Patients were randomized in a 2:1 manner to BV pacing (n=146) or permanent RV pacing (n=106). Patients, but not treating physicians, were blinded to randomization during the study.

Principal Findings:

Pacing implantation was successful in 102 of the 146 patients in the BV group and 82 of the 106 patients in the RV group.

Mean distance walked during the six-minute walk test at six months was 345.6 m in the BV group versus 323.6 m in the RV group, an improvement of 82.4 m and 56.8 m, respectively (p=0.03). Peak VO2 at six months increased by 1.02 ml/kg/min in the BV group (p<0.01), but did not change significantly in the RV group (0.09 ml/kg/min, p=0.43). Exercise duration was significantly improved in the BV group (41.6, p<0.01), but there was no difference in the RV group (19.8, p=0.19).

The SF-36 Health Survey did not differ between groups, with the exception of the mental health assessment, which favored the BV group over the RV group (p=0.03). There was no difference in survival (p=0.21).

Interpretation:

Among patients with chronic AF refractory to pharmaceutical therapy undergoing ablate and pace therapy, use of BV pacing was associated with an improvement in the primary endpoint of exercise capacity at six months compared with permanent RV pacing. Improvements were noted with BV therapy in the three measures of functional capacity of six-minute walk test distance, peak VO2, and exercise duration.

References:

Doshi RN, Daoud EG, Fellows C, et al. Left ventricular-based cardiac stimulation post AV nodal ablation evaluation (the PAVE study). J Cardiovasc Electrophysiol. 2005 Nov;16(11):1160-5.

Presented by Dr. Rahul Doshi at the American College of Cardiology Annual Scientific Session, March 2004.

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices

Keywords: Cardiac Pacing, Artificial, Pacemaker, Artificial, Mental Health, Health Surveys


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