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Background: Studies have reported that female sex predicts superior cardiac resynchronization therapy (CRT) response. One theory is that this association is related to smaller female heart size, thus increased relative dyssynchrony at a given QRS duration (QRSd). Our objective was to investigate the mechanisms of sex-specific CRT response relating to heart size, relative dyssynchrony, cardiomyopathy type, QRS morphology, and other patient characteristics., Methods and Results: This is a post hoc analysis of the MORE-CRT MPP (More Response on Cardiac Resynchronization Therapy with Multipoint Pacing)  trial (n=3739, 28% women), with a subgroup analysis of patients with nonischemic cardiomyopathy and left bundle-branch block (n=1308, 41% women) to control for confounding characteristics. A multivariable analysis examined predictors of response to 6 months of conventional CRT, including sex and relative dyssynchrony, measured by QRSd/left ventricular end-diastolic volume (LVEDV). Women had a higher CRT response rate than men (70.1% versus 56.8%, P <0.0001). In subgroup analysis, regression analysis of the nonischemic cardiomyopathy left bundle-branch block subgroup identified QRSd/LVEDV, but not sex, as a modifier of CRT response ( P <0.0039). QRSd/LVEDV was significantly higher in women (0.919) versus men (0.708, P <0.001). CRT response was 78% for female patients with QRSd/LVEDV greater than the median value, compared with 68% with QRSd/LVEDV less than the median value ( P =0.012). The association between CRT response and QRSd/LVEDV was strongest at QRSd <150 ms., Conclusions: In the nonischemic cardiomyopathy left bundle-branch block population, increased relative dyssynchrony in women, who have smaller heart sizes than their male counterparts, is a driver of sex-specific CRT response, particularly at QRSd <150 ms. Women may benefit from CRT at a QRSd <130 ms, opening the debate on whether sex-specific QRSd cutoffs or QRS/LVEDV measurement should be incorporated into clinical guidelines.

Background: The Wireless Stimulation Endocardially for CRT (WiSE-CRT) system is a novel technology used to treat patients with dyssynchronous heart failure (HF) by providing leadless cardiac resynchronization therapy (CRT). Observational studies have demonstrated its safety and efficacy profile, however, the treatment cost-effectiveness has not previously been examined., Methods: A cost-effectiveness evaluation of the WiSE-CRT System was performed using a cohort-based economic model adopting a "proportion in state" structure. In addition to the primary analysis, scenario analyses and sensitivity analyses were performed to test for uncertainty in input parameters. Outcomes were quantified in terms of quality-adjusted life year (QALY) differences., Results: The primary analysis demonstrated that treatment with the WiSE-CRT system is likely to be cost-effective over a lifetime horizon at a QALY reimbursement threshold of £20 000, with a net monetary benefit (NMB) of £3781 per QALY. Cost-effectiveness declines at time horizons shorter than 10 years. Sensitivity analyses demonstrated that average system battery life had the largest impact on potential cost-effectiveness., Conclusion: Within the model limitations, these findings support the use of WiSE-CRT in indicated patients from an economic standpoint. However, improving battery technology should be prioritized to maximize cost-effectiveness in times when health services are under significant financial pressures., (© 2023 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)

Background: Biventricular endocardial pacing (BiV-endo) and left bundle branch area pacing (LBBAP) are novel methods of delivering cardiac resynchronization therapy. These techniques are associated with improved activation times and acute hemodynamic response compared with conventional biventricular epicardial pacing (BiV-epi); however, the effects on repolarization and arrhythmic risk are unknown., Objective: The purpose of this study was to compare the effects of temporary BiV-epi, BiV-endo, and LBBAP on epicardial left ventricular (LV) repolarization using electrocardiographic imaging (ECGi)., Methods: Eleven patients indicated for cardiac resynchronization therapy underwent a temporary pacing protocol with ECGi. BiV-endo was delivered via endocardial stimulation of the LV lateral wall. LBBAP was delivered by pacing the LV septum. Epicardial LV repolarization time (LVRT-95; time taken for 95% of the LV to repolarize), LV RT dispersion, mean LV activation recovery interval (ARI), LV ARI dispersion, and RT gradients were calculated., Results: The protocol was completed in 10 patients. During LBBAP, there were significant reductions in LVRT-95 (94.9 ± 17.4 ms vs 125.0 ± 29.4 ms; P = .03) and LV RT dispersion (29.4 ± 6.3 ms vs 40.8 ± 11.4 ms; P = .015) compared with BiV-epi. In contrast, there were no significant differences between baseline, BiV-epi, or BiV-endo. There was a nonsignificant reduction in mean RT gradients between LBBAP and baseline rhythm (0.74 ± 0.22 ms/mm vs 1.01 ± 0.31 ms/mm; P = .07). There were no significant differences in mean LV ARI or LV ARI dispersion between groups., Conclusion: Temporary LBBAP reduces epicardial dispersion of repolarization compared with conventional BiV-epi. Further study is required to determine whether these repolarization changes on ECGi translate into a reduced risk of ventricular arrhythmia in clinical practice., (Copyright © 2023 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: The WiSE-CRT System (EBR systems, Sunnyvale, CA) permits leadless left ventricular pacing. Currently, no intraprocedural guidance is used to target optimal electrode placement while simultaneously guiding acoustic transmitter placement in close proximity to the electrode to ensure adequate power delivery., Objective: The purpose of this study was to assess the use of computed tomography (CT) anatomy, dynamic perfusion and mechanics, and predicted activation pattern to identify both the optimal electrode and transmitter locations., Methods: A novel CT protocol was developed using preprocedural imaging and simulation to identify target segments (TSs) for electrode implantation, with late electrical and mechanical activation, with ≥5 mm wall thickness without perfusion defects. Modeling of the acoustic intensity from different transmitter implantation sites to the TSs was used to identify the optimal transmitter location. During implantation, TSs were overlaid on fluoroscopy to guide optimal electrode location that were evaluated by acute hemodynamic response (AHR) by measuring the maximal rate of left ventricular pressure rise with biventricular pacing., Results: Ten patients underwent the implantation procedure. The transmitter could be implanted within the recommended site on the basis of preprocedural analysis in all patients. CT identified a mean of 4.8 ± 3.5 segments per patient with wall thickness < 5 mm. During electrode implantation, biventricular pacing within TSs resulted in a significant improvement in AHR vs non-TSs (25.5% ± 8.8% vs 12.9% ± 8.6%; P < .001). Pacing in CT-identified scar resulted in either failure to capture or minimal AHR improvement. The electrode was targeted to the TSs in all patients and was implanted in the TSs in 80%., Conclusion: Preprocedural imaging and modeling data with intraprocedural guidance can successfully guide WiSE-CRT electrode and transmitter implantation to allow optimal AHR and adequate power delivery., (Copyright © 2023 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Biventricular endocardial pacing (BiV-endo) has demonstrated superior cardiac resynchronization compared to conventional biventricular epicardial pacing (BiV-epi). Left bundle branch area pacing (LBBAP) may also achieve effective cardiac resynchronization therapy (CRT)., Objective: The purpose of this study was to compare the acute electrical and hemodynamic effects of BiV-epi, BiV-endo, and LBBAP delivered from the LV endocardium and to assess how myocardial scar affects response., Methods: Eleven patients with heart failure and indications for CRT underwent a temporary pacing study with electrocardiographic imaging (ECGi) and hemodynamic assessment. BiV-endo was delivered by stimulation of the left ventricular (LV) lateral wall, and LBBAP was delivered by stimulation of the LV septum, at the site of a Purkinje potential. LV activation time (LVAT-95), LV dyssynchrony index (LVDI), biventricular activation time (BIVAT-90), and biventricular dyssynchrony index (BIVDI) were calculated. Myocardial scar was assessed using magnetic resonance imaging (MRI)., Results: The protocol was completed in 10 patients. Compared to BiV-epi (LVAT-95: 79.2 ± 13.1 ms; LVDI: 26.6 ± 3.4 ms) LV resynchronization was superior during BiV-endo (LVAT-95: 48.5 ± 14.9 ms; P = .001; LVDI: 16.6 ± 6.4 ms; P = .002) and LBBAP (LVAT-95: 48.9 ± 12.5 ms; P = .001; LVDI: 15.3 ± 3.4 ms; P = .001). Biventricular resynchronization was similarly superior during BiV-endo and LBBAP vs BiV-epi (BIVAT-90 and BIVDI; P <.05). The rate of acute hemodynamic responders was higher during BiV-endo (90%) and LBBAP (70%) vs BiV-epi (50%). The benefits of LBBAP (but not BiV-endo) on LV resynchronization were attenuated when septal scar was present in a subset of 8 patients who underwent MRI., Conclusion: Our findings suggest superior electrical resynchronization and a higher proportion of acute hemodynamic responders during BiV-endo and LBBAP compared to BiV-epi. Electrical resynchronization was similar between BiV-endo and LBBAP; however, septal scar seemed to attenuate response to LBBAP., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: The WiSE-CRT system delivers leadless endocardial left ventricular (LV) pacing to achieve cardiac resynchronization therapy. The electrode is conventionally placed on the lateral wall, but implanting on the LV septum may have advantages, including capture of the left bundle branch, and improved battery longevity owing to reduced distance from the transmitter., Objective: The purpose of this study was to assess the feasibility of leadless LV septal pacing via the WiSE-CRT system., Methods: Two pigs underwent electrode implantation on the LV septum with subsequent anatomical and histological examination. Eight patients underwent implantation of the WiSE-CRT system with deployment of the electrode on the LV septum via an interatrial transseptal approach., Results: Deployment of the electrode on the LV septum was successful in both animals. Histological examination demonstrated electrode tines in close proximity to Purkinje tissue. WiSE-CRT implantation with an LV septal electrode was successful in all patients. Biventricular capture was confirmed, with a significant reduction in QRS duration (187.1 ± 33.8 ms vs 149.5 ± 15.7 ms; P = .009). Temporary LV pacing achieved further QRS reduction (139.8 ± 12.4 ms), and in 4 patients the peak LV activation time in lead V 5 /V 6 was <90 ms, suggesting left bundle branch capture. At early follow-up, the median LV pacing percentage was 98.5% and 5 patients (62.5%) improved symptomatically. The transmitter-to-electrode distance was lower than the distance to the lateral wall during acoustic window screening (8.8 ± 1.6 cm vs 11.9 ± 1.5 cm; P = .002)., Conclusion: Leadless LV septal pacing with the WiSE-CRT system to target the left bundle branch appears feasible. Further study is required to assess the efficacy and safety of this technique., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

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, I 2 , 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; I 2 = 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; I 2 <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., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Purpose: Cardiac resynchronization therapy (CRT) reduces ventricular activation times and electrical dyssynchrony, however the effect on repolarization is unclear. In this study, we sought to investigate the effect of CRT and left ventricular (LV) remodeling on dispersion of repolarization using electrocardiographic imaging (ECGi)., Methods: 11 patients with heart failure and electrical dyssynchrony underwent ECGi 1-day and 6-months post CRT. Reconstructed epicardial electrograms were used to create maps of activation time, repolarization time (RT) and activation recovery intervals (ARI) and calculate measures of RT, ARI and their dispersion. ARI was corrected for heart rate (cARI)., Results: Compared to baseline rhythm, LV cARI dispersion was significantly higher at 6 months (28.2 ± 7.7 vs 36.4 ± 7.2 ms; P = 0.03) but not after 1 day (28.2 ± 7.7 vs 34.4 ± 6.8 ms; P = 0.12). There were no significant differences from baseline to CRT for mean LV cARI or RT metrics. Significant LV remodeling (>15% reduction in end-systolic volume) was an independent predictor of increase in LV cARI dispersion (P = 0.04) and there was a moderate correlation between the degree of LV remodeling and the relative increase in LV cARI dispersion (R = -0.49) though this was not statistically significant (P = 0.12)., Conclusion: CRT increases LV cARI dispersion, but this change was not fully apparent until 6 months post implant. The effects of CRT on LV cARI dispersion appeared to be dependent on LV reverse remodeling, which is in keeping with evidence that the risk of ventricular arrhythmia after CRT is higher in non-responders compared to responders., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)