Preventing ventricular dysfunction in pacemaker patients without advanced heart failure: rationale and design of the PREVENT-HF study (original) (raw)
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Aims Previous experimental and clinical studies have consistently suggested that right ventricular (RV) apical pacing has important adverse effects. Ventricular pacing (VP), however, is required, and cannot be reduced in many patients with atrioventricular (AV) block. The PREVENT-HF study was an international randomized trial that explored differences in left ventricular (LV) remodelling during RV apical vs. biventricular (BIV) pacing in patients with AV block. Methods and Results Patients with an expected VP prevalence ≥80% were assigned to RV apical or BIV pacing. The primary endpoint was the change in LV end-diastolic volume (EDV) .12 months. Secondary endpoints were LV end-systolic volume (ESV), LV ejection fraction (EF), mitral regurgitation (MR), and a combination of heart failure (HF) events and cardiovascular hospitalizations. Overall, 108 patients were randomized (RV: 58; BIV: 50). Intention to treat and on-treatment analyses revealed no significant differences in any of the outcomes. Analysis of covariance (ANCOVA) difference for treatment according to randomization (in mL): LVEDV 23.92 (218.71 to 10.85), P¼0.6; LVESV 21.38 (212.07 to 9.31), P¼0.80; LVEF 2.47 (23.00 to 7.94), P¼0.37. Analysis of covariance difference for the on-treatment analysis: LVEDV 24.90 (220.02 to 10.22, PP¼0.52; LVESV 26.45 (217.28 to 4.38), P¼0.24, LVEF 2.18 (23.37 to 7.73), P¼0.44. Furthermore, secondary endpoints did not differ significantly. Conclusion This study did not demonstrate significant LV volume differences .12 months between RV apical and BIV pacing for AV block. Thus, BIV pacing cannot be recommended as a routine treatment for AV block in these patients. However, the results encourage and inform the design of subsequent larger trials with higher power for detecting small volume changes. ClinicalTrials.gov Identifier: NCT00170326.
Conventional Versus Biventricular Pacing in Heart Failure and Bradyarrhythmia: The COMBAT Study
Journal of Cardiac Failure, 2010
Background: Worsening in clinical and cardiac status has been noted after chronic right ventricular pacing, but it is uncertain whether atriobiventricular (BiVP) is preferable to atrio-right ventricular pacing (RVP). Conventional versus Multisite Pacing for BradyArrhythmia Therapy study (COMBAT) sought to compare BiVP versus RVP in patients with symptomatic heart failure (HF) and atrioventricular (AV) block. Methods and Results: COMBAT is a prospective multicenter randomized double blind crossover study. Patients with New York Heart Association functional class (FC) II-IV, left ventricular ejection fraction (LVEF) !40%, and AV block as an indication for pacing were enrolled. All patients underwent biventricular system implantation and then were randomized to receive successively (group A) RVP-BiVP-RVP, or (group B) BiVP-RVP-BiVP. At the end of each 3-month crossover period, patients were evaluated according to Quality of Life (QoL), FC, echocardiographic parameters, 6-Minute Walk Test (6MWT), and peak oxygen consumption (VO 2max ). Sixty patients were enrolled, and the mean follow-up period was 17.5 6 10.7 months. There were significant improvements in QoL, FC, LVEF, and left ventricular end-systolic volume with BiVP compared with RVP. The effects of pacing mode on 6MWT and VO 2max were not significantly different. Death occurred more frequently with RVP. Conclusion: In patients with systolic HF and AV block requiring permanent ventricular pacing, BiVP is superior to RVP and should be considered the preferred pacing mode. (J Cardiac Fail 2010;16:293e300)
Echocardiography, 2007
Background: Although left ventricular (LV) pacing has been proposed as an alternative to biventricular (BIV) pacing for heart failure (HF) patients, few comparative data are available on the electromechanical effects of these pacing modalities at mid-term follow-up. Aim: To investigate the clinical and echocardiographic effects of LV versus BIV pacing in a mid-term randomized study. Methods: After implantation of a device with LV/BIV pacing capabilities, 22 patients with chronic HF and left bundle branch block were randomized to LV or BIV pacing. Patients were assessed both preimplantation and after 3 months by clinical examination, ECG and echocardiography with pulsed tissue Doppler imaging. Results: At 3 months LV pacing improved clinical parameters, LV ejection fraction (+5%, range 5-8%, P = 0.007) and intraventricular dyssynchrony (−40 ms, range −50 to −15 ms, in septal to lateral delay, P = 0.008) to a similar extent to BIV pacing. A decrease in interventricular mechanical delay (−25 ms, range −40 to −5 ms, P = 0.008) and QRS duration (−28 ms, range −40 to −5 ms, P = 0.008) was observed in BIV, but not in LV patients. Conclusion: In this pilot evaluation, LV pacing appeared to be associated with clinical benefits similar to BIV pacing at mid-term follow-up, and this was combined with an improvement in intraventricular dyssynchrony, regardless of variations in interventricular dyssynchrony and QRS duration. Echocardiographic evaluation of intraventricular dyssynchrony seems to be an appropriate method for assessing the chronic response to LV pacing. (ECHOCARDIOGRAPHY, Volume 25, February 2008) cardiac pacing, Doppler tissue imaging, heart failure Cardiac resynchronization therapy (CRT) has been shown to improve symptoms, exercise capacity, quality of life, and survival in patients with severe drug-refractory heart failure and left ventricular (LV) dyssynchrony. 1-3 These benefits are mainly related to an improvement in ventricular synchronicity, leading to improved cardiac function. 4 LV pacing alone
Arquivos Brasileiros De Cardiologia, 2002
Received for publication on Accepted on Purpose -To analyze the influence of biventricular pacing (BP) on clinical behavior, ventricular arrhythmia (VA) prevalence, and left ventricular ejection fraction (LV EF) by gated ventriculography. Methods -Twenty-four patients with left bundle branch block (LBBB) and NYHA class III and IV underwent pacemaker implantation and were randomized either to the conventional or BP group, all receiving BP after 6 months. Results -Sixteen patients were in NYHA class IV (66.6%) and 8 were in class III (33.4%). After 1-year followup, 14 patients were in class II (70%) and 5 were in class III (25%). Two sudden cardiac deaths occurred. A significant reduction in QRS length was found with BP (p=0.006). A significant statistical increase, from a mean of 19.13 ± 5.19% (at baseline) to 25.33 ± 5.90% (with BP) was observed in LVEF Premature ventricular contraction prevalence decreased from a mean of 10,670.00 ± 12,595.39 SD or to a mean of 3,007.00 ± 3,216.63 SD PVC/24 h with BP (p<0.05). Regarding the hospital admission rate over 1 year, we observed a significant reduction from 60. To 16 admissions with BP (p<0.05). Conclusion -Patients with LBBB and severe heart failure experienced, with BP, a significant NYHA class and LVEF improvement. A reduction in the hospital admission rate and VA prevalence also occurred.
A pilot experience with permanent biventricular pacing to treat advanced heart failure
American Heart Journal, 2000
at least it cannot correct the marked asynchrony of ventricular activation, contraction, and relaxation, which characterizes a number of patients with chronic left ventricular (LV) systolic dysfunction. Such is the case in particular in patients with intraventricular conduction delay (IVCD). Biventricular pacing (BVP), which simultaneously activates both ventricles, may contribute to correcting the asynchrony and thus improve cardiac performance. Several acute hemodynamic studies have shown that temporary biventricular pacing significantly improved hemodynamics. The aim of this prospective pilot but uncontrolled study was to assess the long-term clinical effects of permanent BVP in patients with drug-refractory heart failure secondary to advanced LV systolic dysfunction and IVCD.
Europace, 2006
Aims To investigate whether patients with previously implanted conventional pacemakers and severe heart failure benefit from an upgrade to a biventricular system. Methods and results Study inclusion criteria were New York Heart Association (NYHA) classes III and IV, dominant paced rhythm, and no left bundle branch block in the pre-pacing ECG. Ten patients with pacemakers (four VVIR due to slow atrial fibrillation and six DDDR, of which four were due to high-degree atrioventricular block and two to sinus node disease) were upgraded to a biventricular pacing (BVP) system. The median duration of pacing before the upgrade was 5.7 years. Assessments of 6-min walk test, symptom score, brain natriuretic peptide (pro-BNP), and echocardiography were made pre-operatively. After a run-in period of 1 month in BVP following the upgrade, the patients were randomized to a 2-month period in either BVP or right ventricular pacing (RVP), followed by 2 months in the other mode, in a double-blind crossover fashion. After each period, the pre-operative measurements were repeated. After study completion, patients were asked to select their preferred period. The median 6-min walking distance was significantly longer in BVP (400 m) vs. RVP (315 m), P ¼ 0.02. The symptom score was also significantly better in BVP (P ¼ 0.005). Median pro-BNP was significantly lower in BVP than in RVP, 3030 vs. 5064 ng/L (P ¼ 0.005). Six patients demanded an early crossover in RVP but none in BVP (P ¼ 0.015), and all patients except one expressed a preference for BVP. However, echo parameters did not show any significant differences between BVP and RVP. Conclusion Pacemaker patients with heart failure and dominant paced heart rhythm benefit substantially from an upgrade to BVP, in terms of physical performance and symptoms. The upgrade resulted in significantly improved cardiac function as reflected by reduced levels of pro-BNP.
Biventricular pacing for atrioventricular block and systolic dysfunction
The New England journal of medicine, 2013
BACKGROUND Right ventricular pacing restores an adequate heart rate in patients with atrioventricular block, but high percentages of right ventricular apical pacing may promote left ventricular systolic dysfunction. We evaluated whether biventricular pacing might reduce mortality, morbidity, and adverse left ventricular remodeling in such patients. RESULTS Of 918 patients enrolled, 691 underwent randomization and were followed for an average of 37 months. The primary outcome occurred in 190 of 342 patients (55.6%) in the right-ventricular-pacing group, as compared with 160 of 349 (45.8%) in the biventricular-pacing group. Patients randomly assigned to biventricular pacing had a significantly lower incidence of the primary outcome over time than did those assigned to right ventricular pacing (hazard ratio, 0.74; 95% credible interval, 0.60 to 0.90); results were similar in the pacemaker and ICD groups. Left ventricular leadrelated complications occurred in 6.4% of patients. CONCLUSIONS Biventricular pacing was superior to conventional right ventricular pacing in patients with atrioventricular block and left ventricular systolic dysfunction with NYHA class I, II, or III heart failure. (Funded by Medtronic; BLOCK HF ClinicalTrials.gov number, NCT00267098.
European Heart Journal, 2002
One third of chronic heart failure patients have major intraventricular conduction and uncoordinated ventricular contraction. Non-controlled studies suggest that biventricular pacing may improve haemodynamics and well-being by reducing ventricular asynchrony. The aim of this trial was to assess the clinical efficacy and safety of this new therapy in patients with chronic atrial fibrillation. Fifty nine NYHA class III patients with left ventricular systolic dysfunction, chronic atrial fibrillation, slow ventricular rate necessitating permanent ventricular pacing, and a wide QRS complex (paced width >or=200 ms), were implanted with transvenous biventricular-VVIR pacemakers. This single-blind, randomized, controlled, crossover study compared the patients' parameters, as monitored during two 3-month treatment periods of conventional right-univentricular vs biventricular pacing. The primary end-point was the 6-min walked distance, secondary end-points were peak oxygen uptake, quality-of-life, hospitalizations, patients' preferred study period and mortality. Because of a higher than expected drop-out rate (42%), only 37 patients completed both crossover phases. In the intention-to-treat analysis, we did not observe a significant difference. However, in the patients with effective therapy the mean walked distance increased by 9.3% with biventricular pacing (374+/-108 vs 342+/-103 m in univentricular;P =0.05). Peak oxygen uptake increased by 13% (P=0.04). Hospitalizations decreased by 70% and 85% of the patients preferred the biventricular pacing period (P<0.001). As compared with conventional VVIR pacing, effective biventricular pacing seems to improve exercise tolerance in NYHA class III heart failure patients with chronic atrial fibrillation and wide paced-QRS complexes. Further randomized controlled studies are required to definitively validate this therapy in such patients.
2010
The goal of this analysis was to determine the appropriate biventricular pacing target in patients with heart failure (HF). Background Cardiac resynchronization therapy (CRT) decreases the risk of death and HF hospitalization. However, the appropriate amount of biventricular pacing is ill-defined. Methods Mortality and HF hospitalization data from patients undergoing CRT in 2 trials (CRT RENEWAL [Cardiac Resynchronization Therapy Registry Evaluating Patient Response with RENEWAL Family Devices] and REFLEx [ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance Study]; n ϭ 1,812) were analyzed in a post-hoc fashion. Subjects were grouped based on percent biventricular pacing quartiles with the use of Kaplan-Meier survival analysis.