Dataset Information

Optimal Cardiac Resynchronization Therapy Pacing Rate in Non-Ischemic Heart Failure Patients: A Randomized Crossover Pilot Trial.

ABSTRACT:

Background

The optimal pacing rate during cardiac resynchronization therapy (CRT) is unknown. Therefore, we investigated the impact of changing basal pacing frequencies on autonomic nerve function, cardiopulmonary exercise capacity and self-perceived quality of life (QoL).

Methods

Twelve CRT patients with non-ischemic heart failure (NYHA class II-III) were enrolled in a randomized, double-blind, crossover trial, in which the basal pacing rate was set at DDD-60 and DDD-80 for 3 months (DDD-R for 2 patients). At baseline, 3 months and 6 months, we assessed sympathetic nerve activity by microneurography (MSNA), peak oxygen consumption (pVO2), N-terminal pro-brain natriuretic peptide (p-NT-proBNP), echocardiography and QoL.

Results

DDD-80 pacing for 3 months increased the mean heart rate from 77.3 to 86.1 (p = 0.001) and reduced sympathetic activity compared to DDD-60 (51±14 bursts/100 cardiac cycles vs. 64±14 bursts/100 cardiac cycles, p<0.05). The mean pVO2 increased non-significantly from 15.6±6 mL/min/kg during DDD-60 to 16.7±6 mL/min/kg during DDD-80, and p-NT-proBNP remained unchanged. The QoL score indicated that DDD-60 was better tolerated.

Conclusion

In CRT patients with non-ischemic heart failure, 3 months of DDD-80 pacing decreased sympathetic outflow (burst incidence only) compared to DDD-60 pacing. However, Qol scores were better during the lower pacing rate. Further and larger scale investigations are indicated.

Trial registration

ClinicalTrials.gov NCT02258061.

SUBMITTER: Ghotbi AA

PROVIDER: S-EPMC4575161 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Optimal Cardiac Resynchronization Therapy Pacing Rate in Non-Ischemic Heart Failure Patients: A Randomized Crossover Pilot Trial.

Ghotbi Adam Ali AA Sander Mikael M Køber Lars L Philbert Berit Th BT Gustafsson Finn F Hagemann Christoffer C Kjær Andreas A Jacobsen Peter K PK

PloS one 20150918 9

<h4>Background</h4>The optimal pacing rate during cardiac resynchronization therapy (CRT) is unknown. Therefore, we investigated the impact of changing basal pacing frequencies on autonomic nerve function, cardiopulmonary exercise capacity and self-perceived quality of life (QoL).<h4>Methods</h4>Twelve CRT patients with non-ischemic heart failure (NYHA class II-III) were enrolled in a randomized, double-blind, crossover trial, in which the basal pacing rate was set at DDD-60 and DDD-80 for 3 mon ...[more]

PMID: 26382243

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Project description:BackgroundLeft bundle branch pacing (LBBP) is emerging as an effective alternative to achieve cardiac resynchronization therapy (CRT) and improve heart function. The purpose of our study was to investigate the feasibility and efficacy of LBBP in heart failure patients with left ventricular ejection fraction (LVEF) <50% and left bundle branch block (LBBB).MethodsAll patients with complete LBBB and LVEF <50% were retrospectively included in the study from April 2018 to April 2021 and underwent CRT via LBBP implantation. ECG, pacing parameters, the New York Heart Association (NYHA) functional class, echocardiographic measurements, and complications were recorded and analyzed at implant and during follow-up of 1, 6, and 12 months.ResultsLeft bundle branch pacing was successful in all 34 patients (mean age 65.6 ± 11.2 years, 67.6% men). A significant decrease in QRS duration (QRSd) was observed after the LBBP operation for 1 month (153.2 ± 1.7 vs. 111.9 ± 2.6 ms, p < 0.01). LBB capture threshold and R-wave amplitude remained stable at 12-month follow-up when compared with implantation values (0.62 ± 0.13 V @ 0.4 ms vs. 0.73 ± 0.21 V @ 0.4 ms, 12.02 ± 5.68 mV vs. 8.58 ± 4.09 mV, respectively). LVEF increased significantly (35.28 ± 1.70% vs. 51.09 ± 1.71%, p < 0.01) accompanied with reduced left ventricular end-diastolic dimension (LVEDd; 65.3 ± 1.99 vs. 53.58 ± 2.07 mm, p < 0.01) and left atrial dimension (LAD; 49.03 ± 1.32 vs. 40.67 ± 1.58 mm, p < 0.01). Normalized LVEF (LVEF ≥ 50%) was found in 70.5% of patients at 12 months. The NYHA classification, brain natriuretic peptide (BNP), and 6-minute walk test (6MWT) were significantly improved at follow-up of 12 months (all p < 0.01 vs. baseline). No deaths or heart failure hospitalizations were observed during the follow-up period.ConclusionThe current work suggested that LBBP was feasible with a high success implantation rate and effective to correct LBBB and improved left ventricular structure and function with a low and stable pacing threshold.

Project description:ImportanceApproximately 40% of patients with heart failure (HF) who are eligible for cardiac resynchronization therapy (CRT) either fail to respond or are untreatable due to anatomical constraints.ObjectiveTo assess the safety and efficacy of a novel, leadless, left ventricular (LV) endocardial pacing system for patients at high risk for a CRT upgrade or whose coronary sinus (CS) lead placement/pacing with a conventional CRT system failed.Design, setting, and participantsThe SOLVE-CRT study was a prospective multicenter trial enrolling January 2018 through July 2022, with follow-up at 6 months. Data were analyzed from January 17, 2018, through February 15, 2023. The trial combined data from an initial randomized, double-blind study (n = 108) and a subsequent single-arm part (n = 75). It took place at 36 centers across Australia, Europe, and the US. Participants were nonresponders, previously untreatable (PU), or high-risk upgrades (HRU). All participants contributed to the safety analysis. The primary efficacy analysis (n = 100) included 75 PU-HRU patients from the single-arm part and 25 PU-HRU patients from the randomized treatment arm.InterventionsPatients were implanted with the WiSE CRT System (EBR Systems) consisting of a leadless LV endocardial pacing electrode stimulated with ultrasound energy delivered by a subcutaneously implanted transmitter and battery.Main outcomes and measuresThe primary safety end point was freedom from type I complications. The primary efficacy end point was a reduction in mean LV end systolic volume (LVESV).ResultsThe study included 183 participants; mean age was 68.1 (SD, 10.3) years and 141 were male (77%). The trial was terminated at an interim analysis for meeting prespecified stopping criteria. In the safety population, patients were either New York Heart Association Class II (34.6%) or III (65.4%). The primary efficacy end point was met with a 16.4% (95% CI, -21.0% to -11.7%) reduction in mean LVESV (P = .003). The primary safety end point was met with an 80.9% rate of freedom from type I complications (P < .001), which included 12 study device system events (6.6%), 5 vascular events (2.7%), 3 strokes (1.6%), and 7 cardiac perforations which mostly occurred early in the study (3.8%).Conclusions and relevanceThe SOLVE-CRT study has demonstrated that leadless LV endocardial pacing with the WiSE CRT system is associated with a reduction in LVESV in patients with HF. This novel system may represent an alternative to conventional CRT implants in some HF patient populations.Trial registrationClinicalTrials.gov Identifier: NCT0292203.

Dataset Information

Optimal Cardiac Resynchronization Therapy Pacing Rate in Non-Ischemic Heart Failure Patients: A Randomized Crossover Pilot Trial.

Background

Methods

Results

Conclusion

Trial registration

Publications

Optimal Cardiac Resynchronization Therapy Pacing Rate in Non-Ischemic Heart Failure Patients: A Randomized Crossover Pilot Trial.

Similar Datasets

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