Right ventricular pacing (RVP) is associated with heart failure and increased mortality. His bundle pacing (HBP) is a physiological alternative to RVP.
This study sought to evaluate clinical outcomes ...of HBP compared to RVP.
All patients requiring initial pacemaker implantation between October 1, 2013, and December 31, 2016, were included in the study. Permanent HBP was attempted in consecutive patients at 1 hospital and RVP at a sister hospital. Implant characteristics, all-cause mortality, heart failure hospitalization (HFH), and upgrades to biventricular pacing (BiVP) were tracked. Primary outcome was the combined endpoint of death, HFH, or upgrade to BiVP. Secondary endpoints were mortality and HFH.
HBP was successful in 304 of 332 consecutive patients (92%), whereas 433 patients underwent RVP. The primary endpoint of death, HFH, or upgrade to BiVP was significantly reduced in the HBP group (83 of 332 patients 25%) compared to RVP (137 of 433 patients 32%; hazard ratio HR: 0.71; 95% confidence interval CI: 0.534 to 0.944; p = 0.02). This difference was observed primarily in patients with ventricular pacing >20% (25% in HBP vs. 36% in RVP; HR: 0.65; 95% CI: 0.456 to 0.927; p = 0.02). The incidence of HFH was significantly reduced in HBP (12.4% vs. 17.6%; HR: 0.63; 95% CI: 0.430 to 0.931; p = 0.02). There was a trend toward reduced mortality in HBP (17.2% vs. 21.4%, respectively; p = 0.06).
Permanent HBP was feasible and safe in a large real-world population requiring permanent pacemakers. His bundle pacing was associated with reduction in the combined endpoint of death, HFH, or upgrade to BiVP compared to RVP in patients requiring permanent pacemakers.
Display omitted
Conventional right ventricular (RV) pacing, particularly RV apical pacing, can have deleterious effects on cardiac function. Long-term RV apical pacing has been associated with increased risk of ...atrial fibrillation, hospitalization for heart failure, pacing-induced cardiomyopathy and associated death. His bundle pacing (HBP) results in physiological ventricular activation and has generated tremendous research interest and enthusiasm. By stimulating the His-Purkinje network directly, HBP results in synchronized ventricular activation, which might translate into improved clinical outcomes compared with dyssynchronous ventricular activation with RV apical pacing. HBP can also overcome bundle branch block patterns, and data are accumulating on the benefit of HBP for cardiac resynchronization therapy. In this Review, we summarize the anatomy of the His bundle and early clinical observations, implantation techniques and available outcome data associated with permanent HBP. We also highlight the challenges with HBP and the need for additional tools and more randomized data before widespread application of permanent HBP.
His bundle pacing (HBP) is the most physiologic form of pacing but associated with higher thresholds and lower success in patients with His-Purkinje conduction disease. Recent reports have described ...transvenous left bundle branch area pacing (LBBAP).
We aimed to prospectively evaluate the feasibility and the electrophysiologic and echocardiographic characteristics of LBBAP.
Patients requiring pacing for bradycardia or heart failure indications (failed left ventricular LV lead) were prospectively enrolled. LBBAP was performed with a Medtronic 3830 lead. Presence of left bundle branch (LBB) potential, paced QRS morphology/duration, and peak LV activation time (pLVAT) were recorded at implant. Pacing threshold and sensing was assessed at implant and follow-up. Echocardiography was performed to assess the approximate lead location and impact on tricuspid valve function.
LBBAP was successful in 93 of 100 (93%) patients. Mean age was 75 ± 13 years; men 69%, left bundle branch block 24%, right bundle branch block 25%, intraventricular conduction defect 8%. Indications for pacing were atrioventricular (AV) block 54%, sinus node dysfunction 23%, AV node ablation 7%, cardiac resynchronization therapy 11%, HBP lead failure 7%. Baseline QRS duration was 133 ± 35 ms. Paced QRS duration was 136 ± 17 ms. LBB potentials were observed in 63 patients with left bundle branch - ventricle (LBB-V) interval of 27 ± 6 ms. pLVAT was 75 ± 16 ms. Pacing threshold at implant was 0.6 ± 0.4 V @ 0.5 ms and R waves were 10 ± 6 mV and remained stable at median follow-up of 3 months. The lead depth in the septum was approximately 1.4 ± 0.23 cm.
LBBAP was feasible in a high percentage of patients with low thresholds during acute follow-up. HBP and LBBAP may significantly increase the overall success of physiologic pacing.
Permanent cardiac pacing of the His-bundle restores and retains normal electrical activation of the ventricles. Data on His-bundle pacing (HBP) are largely limited to small single-centre reports, and ...clinical benefits and risks have not been systematically examined. We sought to systematically examine published studies of patients undergoing permanent HBP and quantify the benefits and risks of the therapy.
PubMed, Embase, and Cochrane Library were searched for full-text articles on permanent HBP. Clinical outcomes of interest included implant success rate, procedural and lead complications, pacing thresholds, QRS duration, and ejection fraction at follow-up, and mortality. Data were extracted and summarized. Where possible, meta-analysis of aggregate data was performed. Out of 2876 articles, 26 met the inclusion criteria representing 1438 patients with an implant attempt. Average age of patients was 73 years and 62.1% were implanted due to atrioventricular block. Overall average implant success rate was 84.8% and was higher with use of catheter-delivered systems (92.1%; P < 0.001). Average pacing thresholds were 1.71 V at implant and 1.79 V at >3 months follow-up; although, pulse widths varied at testing. Average left ventricular ejection fractions (LVEFs) were 42.8% at baseline and 49.5% at follow-up. There were 43 complications observed in 907 patients across the 17 studies that reported safety information.
Among 26 articles of permanent HBP, the implant success rate averaged 84.8% and LVEF improved by an average of 5.9% during follow-up. Specific reporting of our clinical outcomes of interest varied widely, highlighting the need for uniform reporting in future HBP trials.
Left bundle branch area pacing (LBBAP), a new pacing approach, lacks adequate evaluation.
To assess the feasibility, safety, and acute effect of permanent LBBAP in patients with atrioventricular ...block (AVB).
A total of 33 AVB patients with indications for ventricular pacing were recruited. Electrocardiograms, pacing parameters, echocardiographic measurements, and complications associated with LBBAP were evaluated perioperatively and at 3-month follow-up. Successful LBBAP was defined as a paced QRS morphology of right bundle branch block pattern in lead V
and QRS duration (QRSd) less than 130 ms.
LBBAP was successfully performed in 90.9% (30/33) of patients (mean age: 55.1 ± 18.5 years; 66.7% male). The mean capture threshold was similar during the procedure (0.76 ± 0.26 V at 0.4 ms) and at the 3-month follow-up (0.64 ± 0.20 V at 0.4 ms). The paced QRSd was 112.8 ± 10.9 ms during the procedure and 116.8 ± 10.4 ms at the 3-month follow-up. Baseline left or right bundle branch block was corrected (intrinsic QRSd 153.3 ± 27.8 ms vs paced QRSd 122.2 ± 9.9 ms) with a success rate of 68.7% (11/16). One ventricular septal lead perforation occurred soon after the procedure with characteristics of pacing failure, and lead revision was successful. Cardiac function and left ventricular synchronization by 2-dimensional echocardiographic strain imaging at the 3-month follow-up slightly improved compared with that at baseline.
Permanent LBBAP yielded a stable threshold, a narrow QRSd, and preserved left ventricular synchrony with few complications. Our preliminary results indicate that LBBAP holds promise as an attractive physiological pacing strategy for AVB.
A new technology, leadless pacemaker therapy, was recently introduced clinically to address lead- and pocket-related complications in conventional transvenous pacemaker therapy. These leadless ...devices are self-contained right ventricular single-chamber pacemakers implanted by using a femoral percutaneous approach. In this review of available clinical data on leadless pacemakers, early results with leadless devices are compared with historical results with conventional single-chamber pacing. Both presently manufactured leadless pacemakers show similar complications, which are mostly related to the implant procedure: cardiac perforation, device dislocation, and femoral vascular access site complications. In comparison with conventional transvenous single-chamber pacemakers, slightly higher short-term complication rates have been observed: 4.8% for leadless pacemakers versus 4.1% for conventional pacemakers. The complication rate of the leadless pacemakers is influenced by the implanter learning curve for this new procedure. No long-term outcome data are yet available for the leadless pacemakers. Larger leadless pacing trials, with long-term follow-up and direct randomized comparison with conventional pacing systems, will be required to define the proper clinical role of these leadless systems. Although current leadless pacemakers are limited to right ventricular pacing, future advanced, communicating, multicomponent systems are expected to expand the potential benefits of leadless therapy to a larger patient population.
A Dual-Chamber Leadless Pacemaker Knops, Reinoud E; Reddy, Vivek Y; Ip, James E ...
The New England journal of medicine,
06/2023, Letnik:
388, Številka:
25
Journal Article
Recenzirano
Single-chamber ventricular leadless pacemakers do not support atrial pacing or consistent atrioventricular synchrony. A dual-chamber leadless pacemaker system consisting of two devices implanted ...percutaneously, one in the right atrium and one in the right ventricle, would make leadless pacemaker therapy a treatment option for a wider range of indications.
We conducted a prospective, multicenter, single-group study to evaluate the safety and performance of a dual-chamber leadless pacemaker system. Patients with a conventional indication for dual-chamber pacing were eligible for participation. The primary safety end point was freedom from complications (i.e., device- or procedure-related serious adverse events) at 90 days. The first primary performance end point was a combination of adequate atrial capture threshold and sensing amplitude at 3 months. The second primary performance end point was at least 70% atrioventricular synchrony at 3 months while the patient was sitting.
Among the 300 patients enrolled, 190 (63.3%) had sinus-node dysfunction and 100 (33.3%) had atrioventricular block as the primary pacing indication. The implantation procedure was successful (i.e., two functioning leadless pacemakers were implanted and had established implant-to-implant communication) in 295 patients (98.3%). A total of 35 device- or procedure-related serious adverse events occurred in 29 patients. The primary safety end point was met in 271 patients (90.3%; 95% confidence interval CI, 87.0 to 93.7), which exceeded the performance goal of 78% (P<0.001). The first primary performance end point was met in 90.2% of the patients (95% CI, 86.8 to 93.6), which exceeded the performance goal of 82.5% (P<0.001). The mean (±SD) atrial capture threshold was 0.82±0.70 V, and the mean P-wave amplitude was 3.58±1.88 mV. Of the 21 patients (7%) with a P-wave amplitude of less than 1.0 mV, none required device revision for inadequate sensing. At least 70% atrioventricular synchrony was achieved in 97.3% of the patients (95% CI, 95.4 to 99.3), which exceeded the performance goal of 83% (P<0.001).
The dual-chamber leadless pacemaker system met the primary safety end point and provided atrial pacing and reliable atrioventricular synchrony for 3 months after implantation. (Funded by Abbott Medical; Aveir DR i2i ClinicalTrials.gov number, NCT05252702.).
Cardiac resynchronization therapy (CRT) via biventricular pacing has demonstrated clinical benefits in patients with heart failure (HF) and ventricular dyssynchrony. Other approaches of CRT is little ...known.
The purpose of this study was to assess the feasibility, safety, and efficacy of left bundle branch area pacing (LBBAP) in patients with HF and left bundle branch block (LBBB).
Eleven consecutive patients with HF, reduced left ventricular ejection fraction and LBBB and indicated for CRT were recruited. LBBAP was achieved via transventricular septal approach and characterized by narrower QRS duration, shortened peak left ventricular activation time, and right bundle branch conduction delay on the electrocardiogram. Electrocardiogram, echocardiogram, and cardiac function were evaluated at baseline and follow-up. Interventricular mechanical delay and 3-dimensional tissue synchronization imaging during LBBAP and intrinsic LBBB status were measured by echocardiography at follow-up.
LBBAP significantly shortened QRS duration (from baseline 180.00 ± 15.86 ms to 129.09 ± 15.94 ms; P < .01) and left ventricular activation time (from baseline 108.18 ± 15.54 ms to 80.91 ± 9.95 ms; P < .01). Interventricular mechanical delay and the standard deviation of tissue synchronization imaging of 12 left ventricular (LV) segments were significantly shorter during LBBAP than in intrinsic LBBB status (both with P < .01). At a mean follow-up period of 6.7 months, New York Heart Association functional class, plasma level of B-type natriuretic peptide, LV end-systolic diameter, and left ventricular ejection fraction were significantly improved (all with P < .05 vs baseline).
The study demonstrates that LBBAP is clinically feasible in patients with systolic HF and LBBB. LBBAP can be a new CRT technique to correct LBBB, provide ventricular synchrony, and improve clinical symptoms with LV reverse remodeling.
In patients with or without left bundle branch block, left bundle branch pacing (LBBP) can produce near normalization of QRS duration (QRSd). This has recently emerged as an alternative technique to ...His bundle pacing.
The purpose of this study was to characterize a novel approach for LBBP in patients with bradycardia indications for pacing and to assess implant success rate and midterm safety.
Patients with bradycardia indications for pacing underwent LBBP by a trans-ventricular-septal method in the basal ventricular septum. Procedural success, pacing parameters, and complications were assessed at implantation and at 3 months follow-up.
This prospective study evaluated 87 patients (sinus node dysfunction 67.8%; atrioventricular conduction disease 32.2%) undergoing pacemaker implantation. LBBP implantation succeeded in 80.5% (70/87) of patients and the remaining 17 patients received right ventricular septal pacing. The procedure time of LBBP implantation was 18.0 ± 8.8 minutes with a fluoroscopic exposure time of 3.9 ± 2.7 minutes. LBBP produced narrower electrocardiographic QRSd than did right ventricular septal pacing (113.2 ± 9.9 ms vs 144.4 ± 12.8 ms; P < .001). There were no major implantation-related complications. The pacing threshold was low (0.76 ± 0.22 V at implantation and 0.71 ± 0.23 V at 3 months), with no loss of capture or lead dislodgment observed.
This study demonstrates that in patients with standard bradycardia pacing indications, LBBP results in QRSd < 120 ms in most patients and can be performed successfully and safely in the majority of patients.
PDF
