Dataset Information

Impact of cardiac resynchronization therapy optimization inside a heart failure programme: a real-world experience.

ABSTRACT:

Aims

This study sought to describe and evaluate the impact of a routine in-hospital cardiac resynchronization therapy (CRT) programme, including comprehensive heart failure (HF) evaluation and systematic echo-guided CRT optimization.

Methods and results

CRT implanted patients were referred for optimization programme at 3 to 12 months from implantation. The program included clinical and biological status, standardized screening for potential cause of CRT non-response and systematic echo-guided atrioventricular and interventricular delays (AVd and VVd) optimization. Initial CRT-response and improvement at 6 months post-optimization were assessed with a clinical composite score (CCS). Major HF events were tracked during 1 year after optimization. A total of 227 patients were referred for CRT optimization and enrolled (71 ± 11 years old, 77% male, LVEF 30.6 ± 7.9%), of whom 111 (48.9%) were classified as initial non-responders. Left ventricular lead dislodgement was noted in 4 patients (1.8%), and loss or ≤90% biventricular capture in 22 (9.7%), mostly due to arrhythmias. Of the 196 patients (86%) who could undergo echo-guided CRT optimization, 71 (36.2%) required VVd modification and 50/144 (34.7%) AVd modification. At 6 months post-optimization, 34.3% of the initial non-responders were improved according to the CCS, but neither AVd nor VVd echo-guided modification was significantly associated with CCS-improvement. After one-year follow-up, initial non-responders maintained a higher rate of major HF events than initial responders, with no significant difference between AVd/VVd modified or not.

Conclusions

Our study supports the necessity of a close, comprehensive and multidisciplinary follow-up of CRT patients, without arguing for routine use of echo-guided CRT optimization.

SUBMITTER: Moulin T

PROVIDER: S-EPMC9715781 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

Impact of cardiac resynchronization therapy optimization inside a heart failure programme: a real-world experience.

Moulin Thibaut T Hamon David D Djouadi Kamila K D'Humières Thomas T Elbaz Nathalie N Boukantar Madjid M Zerbib Céline C Rouffiac Ségolène S Dhanjal Tarvinder S TS Ernande Laura L Derumeaux Geneviève G Teiger Emmanuel E Damy Thibaud T Lellouche Nicolas N

ESC heart failure 20220624 5

<h4>Aims</h4>This study sought to describe and evaluate the impact of a routine in-hospital cardiac resynchronization therapy (CRT) programme, including comprehensive heart failure (HF) evaluation and systematic echo-guided CRT optimization.<h4>Methods and results</h4>CRT implanted patients were referred for optimization programme at 3 to 12 months from implantation. The program included clinical and biological status, standardized screening for potential cause of CRT non-response and systematic ...[more]

PMID: 35748123

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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.

Project description:BackgroundSuboptimal device programming is among the reasons for reduced response to cardiac resynchronization therapy (CRT). However, whether systematic optimization is beneficial remains unclear, particularly late after CRT implantation. The aim of this single-center cohort study was to assess the effect of systematic atrioventricular delay (AVD) optimization on echocardiographic and device parameters.MethodsPatients undergoing CRT optimization at the University Hospital Zurich between March 2011 and January 2013, for whom a follow-up was available, were included. AVD optimization was based on 12-lead electrocardiography (ECG) and echocardiographic left ventricular inflow characteristics. Parameters were assessed at the time of CRT optimization and follow-up, and were compared between patients with AVD optimization (intervention group) and those for whom no AVD optimization was deemed necessary (control group).ResultsEighty-one patients with a mean age of 64 ± 11 years were included in the analysis. In 73% of patients, AVD was deemed suboptimal and was changed accordingly. After a median follow-up time of 10.4 (IQR 6.2 to 13.2) months, the proportion of patients with sufficient biventricular pacing (> 97% pacing) was greater in the intervention group (78%) compared to controls (50%). Furthermore, AVD adaptation was associated with an improvement in interventricular mechanical delay (decrease of 6.6 ± 26.2 ms vs. increase of 4.3 ± 17.7 ms, p = 0.034) and intraventricular septal-to-lateral delay (decrease of 0.9 ± 48.1 ms vs. increase of 15.9 ± 15.7 ms, p = 0.038), as assessed by tissue Doppler imaging. Accordingly, a reduction was observed in mitral regurgitation along with a trend towards reduced left ventricular volumes.ConclusionsIn this "real-world" setting systematic AVD optimization was associated with beneficial effects regarding biventricular pacing and left ventricular remodeling. These data show that AVD optimization may be advantageous in selected CRT patients.

Dataset Information

Impact of cardiac resynchronization therapy optimization inside a heart failure programme: a real-world experience.

Aims

Methods and results

Conclusions

Publications

Impact of cardiac resynchronization therapy optimization inside a heart failure programme: a real-world experience.

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