TY - JOUR
T1 - Leadless left ventricular endocardial pacing for cardiac resynchronization therapy
T2 - A systematic review and meta-analysis
AU - Wijesuriya, Nadeev
AU - Elliott, Mark K.
AU - Mehta, Vishal
AU - Sidhu, Baldeep S.
AU - Behar, Jonathan M.
AU - Niederer, Steven
AU - Rinaldi, Christopher A.
N1 - Funding Information:
Funding Sources: The authors are supported by the Wellcome/EPSRC Centre for Medical Engineering (WT203148/Z/16/Z). Dr Sidhu is funded from a project grant from the NIHR. Dr Niederer acknowledges support from the UK Engineering and Physical Sciences Research Council (EP/M012492/1, NS/A000049/1, and EP/P01268X/1), the British Heart Foundation (PG/15/91/31812,PG/13/37/30280, SP/18/6/33805), US National Institutes of Health (NIH R01-HL152256), European Research Council (ERC PREDICT-HF 864055), and Kings Health Partners London National Institute for Health Research (NIHR) Biomedical Research Centre. Disclosures: Drs Elliott and Mehta have received fellowship funding from Abbott. Dr Sidhu has received speaker fees from EBR Systems, outside the submitted work. Dr Behar receives research funding and/or consultation fees from Abbott, Siemens Healthcare, EBR Systems, and Biosense Webster outside of the submitted work. Dr Rinaldi receives research funding and/or consultation fees from Abbott, Medtronic, Boston Scientific, Spectranetics, and MicroPort outside of the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Funding Information:
Funding Sources: The authors are supported by the Wellcome/EPSRC Centre for Medical Engineering ( WT203148/Z/16/Z ). Dr Sidhu is funded from a project grant from the NIHR . Dr Niederer acknowledges support from the UK Engineering and Physical Sciences Research Council ( EP/M012492/1 , NS/A000049/1 , and EP/P01268X/1 ), the British Heart Foundation ( PG/15/91/31812 , PG/13/37/30280 , SP/18/6/33805 ), US National Institutes of Health ( NIH R01-HL152256 ), European Research Council (ERC PREDICT-HF 864055 ), and Kings Health Partners London National Institute for Health Research (NIHR) Biomedical Research Centre . Disclosures: Drs Elliott and Mehta have received fellowship funding from Abbott. Dr Sidhu has received speaker fees from EBR Systems, outside the submitted work. Dr Behar receives research funding and/or consultation fees from Abbott, Siemens Healthcare, EBR Systems, and Biosense Webster outside of the submitted work. Dr Rinaldi receives research funding and/or consultation fees from Abbott , Medtronic, Boston Scientific, Spectranetics, and MicroPort outside of the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2022 Heart Rhythm Society
PY - 2022/7
Y1 - 2022/7
N2 - Background: Leadless left ventricular (LV) endocardial pacing to achieve cardiac resynchronization therapy (CRT) is a novel procedure for treatment of patients with dyssynchronous heart failure. Current evidence is limited to observational studies with small patient numbers. Objective: The purpose of this systematic review and meta-analysis was to assess the safety and efficacy of leadless LV endocardial pacing. Methods: A literature search was conducted through PubMed, EMBASE, and Cochrane databases. Mean differences (MDs) in New York Heart Association (NYHA) functional class and LV ejection fraction (LVEF) from baseline to 6 months postprocedure were combined using a random effects model. Heterogeneity was evaluated using the Cochrane Q test, I2, meta-regression, and sensitivity analysis. Funnel plots were constructed to detect publication bias. Results: Five studies with 181 patients were included in the final analysis. Procedural success rate was 90.6%. Clinical response rate was 63%, with mean improvement in NYHA functional class of 0.43 (MD –0.43; 95% confidence interval [CI] –0.76 to –0.1; P = .01), with high heterogeneity (P <.001; I2 = 81.1%). There was a mean increase in LVEF of 6.3% (MD 6.3; 95% CI 4.35–8.19; P <.001, with low heterogeneity (P = 0.84; I2 <0.001%). The echocardiographic response rate was 54%. Procedure-related complication and mortality rates were 23.8% and 2.8%, respectively. Conclusion: The efficacy of leadless LV endocardial pacing for CRT supports its use as a second-line therapy in patients in whom standard CRT is not possible or has been ineffective. Improvements in safety profile will facilitate widespread uptake in the treatment of these patients.
AB - Background: Leadless left ventricular (LV) endocardial pacing to achieve cardiac resynchronization therapy (CRT) is a novel procedure for treatment of patients with dyssynchronous heart failure. Current evidence is limited to observational studies with small patient numbers. Objective: The purpose of this systematic review and meta-analysis was to assess the safety and efficacy of leadless LV endocardial pacing. Methods: A literature search was conducted through PubMed, EMBASE, and Cochrane databases. Mean differences (MDs) in New York Heart Association (NYHA) functional class and LV ejection fraction (LVEF) from baseline to 6 months postprocedure were combined using a random effects model. Heterogeneity was evaluated using the Cochrane Q test, I2, meta-regression, and sensitivity analysis. Funnel plots were constructed to detect publication bias. Results: Five studies with 181 patients were included in the final analysis. Procedural success rate was 90.6%. Clinical response rate was 63%, with mean improvement in NYHA functional class of 0.43 (MD –0.43; 95% confidence interval [CI] –0.76 to –0.1; P = .01), with high heterogeneity (P <.001; I2 = 81.1%). There was a mean increase in LVEF of 6.3% (MD 6.3; 95% CI 4.35–8.19; P <.001, with low heterogeneity (P = 0.84; I2 <0.001%). The echocardiographic response rate was 54%. Procedure-related complication and mortality rates were 23.8% and 2.8%, respectively. Conclusion: The efficacy of leadless LV endocardial pacing for CRT supports its use as a second-line therapy in patients in whom standard CRT is not possible or has been ineffective. Improvements in safety profile will facilitate widespread uptake in the treatment of these patients.
KW - Cardiac resynchronization therapy
KW - Endocardial pacing
KW - Heart failure
KW - Leadless pacing
KW - Meta-analysis
KW - Systematic review
UR - http://www.scopus.com/inward/record.url?scp=85127354678&partnerID=8YFLogxK
U2 - 10.1016/j.hrthm.2022.02.018
DO - 10.1016/j.hrthm.2022.02.018
M3 - Article
C2 - 35189383
AN - SCOPUS:85127354678
SN - 1547-5271
VL - 19
SP - 1176
EP - 1183
JO - Heart rhythm : the official journal of the Heart Rhythm Society
JF - Heart rhythm : the official journal of the Heart Rhythm Society
IS - 7
ER -