Dataset Information

Standard care vs. TRIVEntricular pacing in Heart Failure (STRIVE HF): a prospective multicentre randomized controlled trial of triventricular pacing vs. conventional biventricular pacing in patients with heart failure and intermediate QRS left bundle branch block.

ABSTRACT:

Aims

To determine whether triventricular (TriV) pacing is feasible and improves CRT response compared to conventional biventricular (BiV) pacing in patients with left bundle branch block (LBBB) and intermediate QRS prolongation (120-150 ms).

Methods and results

Between October 2015 and November 2019, 99 patients were recruited from 11 UK centres. Ninety-five patients were randomized 1:1 to receive TriV or BiV pacing systems. The primary endpoint was feasibility of TriV pacing. Secondary endpoints assessed symptomatic and remodelling response to CRT. Baseline characteristics were balanced between groups. In the TriV group, 43/46 (93.5%) patients underwent successful implantation vs. 47/49 (95.9%) in the BiV group. Feasibility of maintaining CRT at 6 months was similar in the TriV vs. BiV group (90.0% vs. 97.7%, P = 0.191). All-cause mortality was similar between TriV vs. BiV groups (4.3% vs. 8.2%, P = 0.678). There were no significant differences in echocardiographic LV volumes or clinical composite scores from baseline to 6-month follow-up between groups.

Conclusion

Implantation of two LV leads to deliver and maintain TriV pacing at 6 months is feasible without significant complications in the majority of patients. There was no evidence that TriV pacing improves CRT response or provides additional clinical benefit to patients with LBBB and intermediate QRS prolongation and cannot be recommended in this patient group.

Clinical trial registration number

Clinicaltrials.gov: NCT02529410.

SUBMITTER: Gould J

PROVIDER: S-EPMC9071069 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Publications

Standard care vs. TRIVEntricular pacing in Heart Failure (STRIVE HF): a prospective multicentre randomized controlled trial of triventricular pacing vs. conventional biventricular pacing in patients with heart failure and intermediate QRS left bundle branch block.

Gould Justin J Claridge Simon S Jackson Thomas T Sieniewicz Benjamin J BJ Sidhu Baldeep S BS Porter Bradley B Elliott Mark K MK Mehta Vishal V Niederer Steven S Chadwick Humra H Kamdar Ravi R Adhya Shaumik S Patel Nikhil N Hamid Shoaib S Rogers Dominic D Nicolson William W Chan Cheuk F CF Whinnett Zachary Z Murgatroyd Francis F Lambiase Pier D PD Rinaldi Christopher A CA

Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology 20220501 5

<h4>Aims</h4>To determine whether triventricular (TriV) pacing is feasible and improves CRT response compared to conventional biventricular (BiV) pacing in patients with left bundle branch block (LBBB) and intermediate QRS prolongation (120-150 ms).<h4>Methods and results</h4>Between October 2015 and November 2019, 99 patients were recruited from 11 UK centres. Ninety-five patients were randomized 1:1 to receive TriV or BiV pacing systems. The primary endpoint was feasibility of TriV pacing. Sec ...[more]

PMID: 35079787

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Project description:AimsThe purpose of our study was to evaluate the feasibility and efficacy of cardiac resynchronization therapy (CRT) via left bundle branch pacing (LBBP-CRT) compared with optimized biventricular pacing (BVP) with adaptive algorithm (BVP-aCRT) in heart failure with reduced left ventricular ejection fraction ≤35% (HFrEF) and left bundle branch block (LBBB).Methods and resultsOne hundred patients with HFrEF and LBBB undergoing CRT were prospectively enrolled in a non-randomized fashion and divided into two groups (LBBP-CRT, n = 49; BVP-aCRT, n = 51) in four centres. Implant characteristics and echocardiographic parameters were accessed at baseline and during 6-month and 1-year follow-up. The success rate for LBBP-CRT and BVP-aCRT was 98.00% and 91.07%. Fused LBBP had the greatest reduced QRS duration compared to BVP-aCRT (126.54 ± 11.67 vs. 102.61 ± 9.66 ms, P < 0.001). Higher absolute left ventricular ejection fraction (LVEF) and △LVEF was also achieved in LBBP-CRT than BVP-aCRT at 6-month (47.58 ± 12.02% vs. 41.24 ± 10.56%, P = 0.008; 18.52 ± 13.19% vs. 12.89 ± 9.73%, P = 0.020) and 1-year follow-up (49.10 ± 10.43% vs. 43.62 ± 11.33%, P = 0.021; 20.90 ± 11.80% vs. 15.20 ± 9.98%, P = 0.015, P = 0.015). There was no significant difference in response rate between two groups while higher super-response rate was observed in LBBP-CRT as compared to BVP-aCRT at 6 months (53.06% vs. 36.59%, P = 0.016) and 12 months (61.22% vs. 39.22%, P = 0.028) during follow-up. The pacing threshold was lower in LBBP-CRT at implant and during 1-year follow-up (both P < 0.001). Procedure-related complications and adverse clinical outcomes including heart failure hospitalization and mortality were not significantly different in two groups.ConclusionsThe feasibility and efficacy of LBBP-CRT demonstrated better electromechanical resynchronization and higher clinical and echocardiographic response, especially higher super-response than BVP-aCRT in HFrEF with LBBB.

Project description:Background: Little is known about the efficacy of permanent left bundle branch area pacing (LBBAP) in delivering cardiac resynchronization therapy (CRT). This study aimed to evaluate the effect of LBBAP on mechanical synchronization and myocardial work (MW) in heart failure (HF) patients and to compare LBBAP with biventricular pacing (BVP). Methods: This is a multicenter, prospective cohort study. From February 2018 to January 2021, 62 consecutive HF patients with reduced ejection fraction (LVEF ≤ 35%) and complete left bundle branch block (CLBBB) who underwent LBBAP or BVP were enrolled in this study. Echocardiograms and electrocardiograms and were conducted before and 3-6 months after implantation. Intra- and interventricular synchronization were assessed using two-dimensional speckle tracking imaging (2D-STI). The left ventricular pressure-strain loop was obtained by combining left ventricular strain with non-invasive blood pressure to evaluate mechanical efficiency. Results: The echocardiographic response rates were 68.6 and 88.9% in the BVP and LBBAP groups, respectively. Left bundle branch area pacing resulted in significant QRS narrowing (from 177.1 ± 16.7 to 113.0 ± 18.4 ms, P < 0.001) and improvement in LVEF (from 29.9 ± 4.8 to 47.1 ± 8.3%, P < 0.001). The global wasted work (GWW) (410.3 ± 166.6 vs. 283.0 ± 129.6 mmHg%, P = 0.001) and global work efficiency (GWE) (64.6 ± 7.8 vs. 80.5 ± 5.7%, P < 0.001) were significantly improved along with shorter peak strain dispersion (PSD) (143.4 ± 45.2 vs. 92.6 ± 35.1 ms, P < 0.001) and interventricular mechanical delay (IVMD) (56.4 ± 28.5 vs. 28.9 ± 19.0 ms, P < 0.001), indicating its efficiency in improving mechanical synchronization. In comparison with BVP, LBBAP delivered greater improvement of QRS narrowing (-64.1 ± 18.9 vs. -32.5 ± 22.3 ms, P < 0.001) and better mechanical synchronization and efficiency. Conclusions: Left bundle branch area pacing was effective in improving cardiac function, mechanical synchronization, and mechanical efficiency and may be a promising alternative cardiac resynchronization therapy.

Project description:BackgroundLeft bundle branch area pacing (LBBAP) may offer greater physiological benefits than traditional biventricular pacing (BiVP). However, there are limited data comparing the efficacy of LBBAP vs BiVP in patients with systolic heart failure (HF).ObjectiveThe purpose of this meta-analysis was to compare the feasibility and electromechanical and clinical outcomes of both LBBAP and BiVP.MethodsWe conducted a systematic review of studies retrieved from various databases including PubMed, Embase, Google Scholar, Scopus, and Cochrane Central Register of Control Trials (CENTRAL) published up to May 22, 2023. The risk ratio (RR) and standardized mean difference (SMD) with corresponding 95% confidence intervals (CIs) were calculated for dichotomous and continuous outcomes, respectively.ResultsWe included 12 studies with a total of 3004 patients (LBBAP = 1242, BiVP = 1762). Pooled results showed that LBBAP resulted in a significant increase in left ventricular ejection fraction (SMD 0.40, 95% CI 0.25, 0.54, P < .00001), echocardiographic response (RR 1.19, 95% CI 1.10 to 1.29, P < .0001), improvement in New York Heart Association functional class (SMD -0.44, 95% CI -0.65 to -0.23, P < .0001), QRS duration reduction (SMD -0.90, 95% CI -1.14 to -0.66, P < .00001), left ventricular end-diastolic diameter reduction (SMD -0.31, 95% CI -0.57 to -0.05, P = .02), fewer HF hospitalizations (RR 0.72, 95% CI 0.62, 0.85, P < .0001), and improved survival (RR 0.73, 95% CI 0.58, 0.92, P = .007). In addition, LBBAP was associated with shorter fluoroscopy time (SMD -0.94, 95% CI -1.42 to -0.47, P < .0001) and lower pacing threshold at implantation (SMD -1.03, 95% CI -1.32 to -0.74, P < .00001) and at 6 months (SMD -1.44, 95% CI -2.11 to -0.77, P < .0001) as compared with BiVP.ConclusionCompared with BiVP, LBBAP was associated with better electromechanical and clinical outcomes, including left ventricular ejection fraction, QRS duration, echocardiographic response, New York Heart Association functional class, HF hospitalization, and all-cause mortality in patients with systolic HF.

Project description:BackgroundQRS transition criteria during dynamic manoeuvers are the gold-standard for non-invasive confirmation of left bundle branch (LBB) capture, but they are seen in <50% of LBB area pacing (LBBAP) procedures.ObjectiveWe hypothesized that transition from left ventricular septal pacing (LVSP) to LBB pacing (LBBP), when observed during lead penetration into the deep interventricular septum (IVS) with interrupted pacemapping, can suggest LBB capture.MethodsQRS transition during lead screwing-in was defined as shortening of paced V6-R wave peak time (RWPT) by ≥10 ms from LVSP to non-selective LBBP (ns-LBBP) obtained during mid to deep septal lead progression at the same target area, between two consecutive pacing manoeuvres. ECG-based criteria were used to compared LVSP and ns-LBBP morphologies obtained by interrupted pacemapping.ResultsSixty patients with demonstrated transition from LVSP to ns-LBBP during dynamic manoeuvers were compared to 44 patients with the same transition during lead screwing-in. Average shortening in paced V6-RWPT was similar among study groups (17.3 ± 6.8 ms vs. 18.8 ± 4.9 ms for transition during dynamic manoeuvres and lead screwing-in, respectively; p = 0.719). Paced V6-RWPT and aVL-RWPT, V6-V1 interpeak interval and the recently described LBBP score, were also similar for ns-LBBP morphologies in both groups. LVSP morphologies showed longer V6-RWPT and aVL-RWPT, shorter V6-V1 interpeak interval and lower LBBP score punctuation, without differences among the two QRS transition groups. V6-RWPT < 75 ms or V6-V1 interpeak interval > 44 ms criterion was more frequently achieved in ns-LBBP morphologies obtained during lead screwing-in compared to those obtained during dynamic manoeuvres (70.5% vs. 50%, respectively p = 0.036).ConclusionsDuring LBBAP procedure, QRS transition from LVSP to ns-LBBP can be observed as the lead penetrates deep into the IVS with interrupted pacemapping. Shortening of at least 10 ms in paced V6-RWPT may serve as marker of LBB capture.

Project description:Cardiac dyssynchrony is the proposed mechanism for pacemaker-induced cardiomyopathy, which can be prevented by biventricular pacing. Left bundle branch pacing and His bundle pacing are novel interventions that imitate the natural conduction of the heart with, theoretically, less interventricular dyssynchrony. One of the surrogate markers of interventricular synchrony is QRS duration. Our study aimed to compare the change of QRS duration before and after implantation between types of cardiac implantable electronic devices (CIEDs): left bundle branch pacing versus His bundle pacing versus biventricular pacing and conventional right ventricular pacing. A literature search for studies that reported an interval change of QRS duration after CIED implantation was conducted utilizing the MEDLINE, EMBASE, and Cochrane databases. All relevant works from database inception through November 2020 were included in this analysis. A random-effects model, Bayesian network meta-analysis was used to analyze QRS duration changes (eg, electrical cardiac synchronization) across different CIED implantations. The mean study sample size, from 14 included studies, was 185 subjects. The search found 707 articles. After exclusions, 14 articles remained with 2,054 patients. The His bundle pacing intervention resulted in the most dramatic decline in QRS duration (mean difference, - 53 ms; 95% CI - 67, - 39), followed by left bundle branch pacing (mean difference, - 46 ms; 95% CI - 60, - 33), and biventricular pacing (mean difference, - 19 ms; 95% CI - 37, - 1.8), when compared to conventional right ventricle apical pacing. When compared between LBBP and HBP, showed no statistically significant wider QRS duration in LBBP with mean different 6.5 ms. (95% CI - 6.7, 21). Our network meta-analysis found that physiologic pacing has the greatest effect on QRS duration after implantation. Thus, HBP and LBBP showed no significant difference between QRS duration after implantation. Physiologic pacing interventions result in improved electrocardiography markers of cardiac synchrony, narrower QRS duration, and might lower electromechanical dyssynchrony.

Dataset Information

Standard care vs. TRIVEntricular pacing in Heart Failure (STRIVE HF): a prospective multicentre randomized controlled trial of triventricular pacing vs. conventional biventricular pacing in patients with heart failure and intermediate QRS left bundle branch block.

Aims

Methods and results

Conclusion

Clinical trial registration number

Publications

Standard care vs. TRIVEntricular pacing in Heart Failure (STRIVE HF): a prospective multicentre randomized controlled trial of triventricular pacing vs. conventional biventricular pacing in patients with heart failure and intermediate QRS left bundle branch block.

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