The long-term impact of permanent pacemaker (PPM) implantation on survival after cardiac surgery remains ill defined. We aimed to investigate the effect of PPM on survival and explore factors driving ...outcomes using meta-regression according to the type of surgery.
MEDLINE, EMBASE, and the Cochrane Library Central Register of Controlled Trials were searched through October 2023 to identify studies reporting the long-term outcomes of PPM implantation. The primary outcome was all-cause mortality during follow-up. The secondary outcome was heart failure rehospitalization. The subgroup analysis and meta-regression analysis were performed according to the type of surgery.
A total of 28 studies met the inclusion criteria. 183,555 patients (n = 6298; PPM, n = 177,257; no PPM) were analyzed for all-cause mortality, with a weighted median follow-up of 79.7 months. PPM implantation was associated with increased risks of all-cause mortality during follow-up (hazard ratio, 1.22; confidence interval, 1.08-1.38, P < .01) and heart failure rehospitalization (hazard ratio, 1.24; confidence interval, 1.01-1.52, P = .04). Meta-regression demonstrated the adverse impact of PPM was less prominent in patients undergoing mitral or tricuspid valve surgery, whereas studies with a greater proportion with aortic valve replacement were associated with worse outcomes. Similarly, a greater proportion with atrioventricular block as an indication of PPM was associated with worse survival.
PPM implantation after cardiac surgery is associated with a greater risk of long-term all-cause mortality and heart failure rehospitalization. This impact is more prominent in patients undergoing aortic valve surgery or atrioventricular block as an indication than those undergoing mitral or tricuspid valve surgery.
Guidelines recommend tricuspid valve (TV) repair for patients with severe tricuspid valve regurgitation (TR) undergoing surgery for degenerative mitral valve (MV) disease, but management of ≤ ...moderate TR is controversial. This study examines the incidence and causes of bradyarrhythmias leading to PPM implantation.
Review of patients undergoing simultaneous TV repair and MV surgery for degenerative MV disease from 2001 to 2022 (N=404). Primary endpoint was the incidence of postoperative PPM implantation. Secondary endpoints included the incidence of high-degree AV block and overall survival.
All patients underwent TV repair at the time of MV surgery; 332 (82%) underwent MV repair and 72 (18%) MV replacement. Tricuspid valve repair techniques included flexible band (n=258, 63.8%), DeVega annuloplasty (n=78, 19.3%), complete flexible ring (n=49, 12.1%), and incomplete rigid ring (n=19, 4.7%). The 30-day mortality was 0.5% (n=2). A total of 35 (8.7%) patients had a PPM implanted postoperatively, 26 (6.4%) for high-degree AV block. On multivariable analysis, only older age was associated with PPM implantation. Patients who received a PPM due to high-degree AV block had reduced overall survival (Figure, p=0.01).
Need for permanent pacing following TV repair at the time of MV surgery is not uncommon, but there are few modifiable factors that might reduce this risk. Careful selection of patients with less-than-severe TR and surgical techniques may reduce PPM-related risks and complications.
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Procedural success and clinical outcomes after transcatheter aortic valve replacement (TAVR) have improved, but residual aortic regurgitation (AR) and new permanent pacemaker implantation (PPI) rates ...remain variable because of a lack of uniform periprocedural management and implantation.
The Optimize PRO study evaluates valve performance and procedural outcomes using an “optimized” TAVR care pathway and the cusp overlap technique (COT) in patients receiving the Evolut PRO/PRO+ (Medtronic) self-expanding valves.
Optimize PRO, a nonrandomized, prospective, postmarket study conducted in the United States, Canada, Europe, Middle East, and Australia, is enrolling patients with severe symptomatic aortic stenosis and no pre-existing pacemaker. Sites follow a standardized TAVR care pathway, including early discharge and a conduction disturbance management algorithm, and transfemoral deployment using the COT.
A total of 400 attempted implants from the United States and Canada comprised the main cohort of this second interim analysis. The mean age was 78.7 ± 6.6 years, and the mean Society of Thoracic Surgeons predictive risk of mortality was 3.0 ± 2.4. The median length of stay was 1 day. There were no instances of moderate or severe AR at discharge. At 30 days, all-cause mortality or stroke was 3.8%, all-cause mortality was 0.8%, disabling stroke was 0.7%, hospital readmission was 10.1%, and cardiovascular rehospitalization was 6.1%. The new PPI rate was 9.8%, 5.8% with 4-step COT compliance. In the multivariable model, right bundle branch block and the depth of the implant increased the risk of PPI, whereas using the 4-step COT lowered 30-day PPI.
The use of the TAVR care pathway and COT resulted in favorable clinical outcomes with no moderate or severe AR and low PPI rates at 30 days while facilitating early discharge and reproducible outcomes across various sites and operators. (Optimize PRO; NCT04091048)
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New-generation transcatheter-heart-valves (THV) have significantly improved technical success and procedural safety of transcatheter-aortic-valve-implantation (TAVI) procedures, but incidence of ...permanent pacemaker implantation (PPI) remains a concern.The study aimed to assess the role of anatomical annulus features in determining peri-procedural conduction disturbances leading to new-PPI following TAVI with the last generation Edwards Sapien balloon-expandable valves (BEV). In the context of a prospective single-center registry, we integrated clinical and procedural predictors of PPI with anatomical data derived from multi-slice-computed-tomography (MSCT). A total of 210 consecutive patients treated with balloon expandable Edwards THV were included in the study from 2015 to 2023. Technical success was achieved in 197 (93.8%) procedures, and 26 patients (12.4%) required new-PPI at 30-day follow-up (median time-to-implantation 3 days). At the univariable logistic-regression analysis, pre-procedural right bundle branch block (RBBB; OR:2.24 95%CI:1.01-4.97, p=0.047), annulus eccentricity ≥0.25 (OR:5.43 95%CI:2.21-13.36, p<0.001), calcium volume at annulus of the right coronary cusp (RCC) >48 mm3 (OR:2.60 95%CI:1.13-5.96, p=0.024) and prosthesis implantation depth greater than membranous septum length (OR:2.17 95%CI: 1.10-4.28, p=0.026) were associated with new-PPI risk. At multivariable analysis pre-procedural RBBB (OR:2.81 95%CI:1.01-7.85, p=0.049), annulus eccentricity ≥0.25 (OR:4.14 95%CI:1.85-9.27, p<0.001), and annulusRCC calcium >48 mm3 (OR:2.89 95%CI:1.07-7.82, p=0.037) were confirmed as independent predictors of new-PPI. In conclusion, specific anatomical features of the aortic valve annulus might have an additive role in determining the occurrence of conduction disturbances in patients undergoing TAVI with BEV. This suggests the possibility to use the MSCT to improve the prediction of post-TAVI new-PPI risk.
Abbreviations. PPI=permanent pacemaker implantation; TAVI=transcatheter aortic valve implantation; STS-PROM=society of thoracic surgeons’ predictive risk of mortality; TAVI=transcatheter aortic valve replacement; EI=eccentricity index; RCC=right coronary cusp; Ca++=calcium; RBBB=right bundle branch block; ID=implantation depth; MS=membranous septum; OR=odds ratio. Display omitted
IntroductionAtrioventricular conduction disturbance leading to permanent pacemaker (PM) implantation is a frequent and relevant complication after transcatheter aortic valve implantation (TAVI). ...There is no recognised monitoring period to allow for resolution after the post-TAVI patients have developed conduction disease. We aimed to evaluate the rate of post-TAVI permanent PM implantation over time, and to determine what pacing percentage these patients have at their first and second follow up, as well as to determine whether their pacing need increased, decreased, or stayed the same.MethodsA retrospective observational study was performed using data collected from the NICOR database for patients who required pacing devices after TAVI implantation in the period of 2019 to 2021 at a single tertiary TAVI centre. Demographic data including age, gender, ECG pre and post TAVI, pacemaker type and number of days between TAVI and device implant, were evaluated. We analysed their ventricular pacing percentage at their initial follow up and subsequent follow up.ResultsOf 883 TAVI patients, 52 (median age 81.5±6.8 p =0.24, 54.7% males) underwent pacing implantation after TAVI. The majority of patients pre-TAVI were in sinus rhythm with no statistically significant difference between the rhythms (sinus rhythm-36 (67.9%), AF-14 (26.4%), AV block-2 (3.8%), Paced-1(1.9%) p 0.11). In post-TAVI patients, 62.3% were in AV block (Sinus-17.0%, AF-9.4%, AF with AV block-1.9%, Ventricular standstill-5.7% Paced-1.9%, AV block and ventricular standstill-1.9% p 0.11). The majority of patients pre-TAVI did not have any right or left bundle branch block with no statistically significant difference between the variables (LBBB-9.4%, RBBB-17.0%, None- 73.6%, p 0.28) whereas 34.6% and 15.4% of patients post-TAVI were LBBB and RBBB respectively (p 0.63). Time to pacemaker implantation was 18.4±45.1days. The majority of patient post-TAVI had a dual chamber pacemaker with no statistically significant difference between the device type across all 3 years. Percentage of ventricular pacing at 6-week check was 50±41(p 0.24) and at 12-month check was 44±43 (p 0.61) (figures 1 and 2)ConclusionsConduction disturbances after transcatheter aortic valve implantation (TAVI) are often transient. Our data shows that the risk needing a PPM post TAVI is 3–10%. The average time from TAVI implant to needing a pacemaker is 18 days (p=0.63). There is no significant difference between the ventricular pacing percentage at the 6 weeks versus the 12 months check over the 3 years. Considering the growing population undergoing TAVI, multi-centred study of permanent pacemaker utilisation, risks, and long-term pacing dependency, should be undertaken to develop nationally agreed guidance on indication and timing of pacing in post-TAVI patients.Abstract 112 Figure 1Abstract 112 Figure 2Conflict of InterestNo
Abstract
Aims
Transcatheter aortic valve implantation (TAVI) has emerged as established treatment option in patients with symptomatic aortic stenosis. Technical developments in valve design have ...addressed previous limitations such as suboptimal deployment, conduction disturbances, and paravalvular leakage. However, there are only limited data available for the comparison of newer generation self-expandable valve (SEV) and balloon-expandable valve (BEV).
Methods and results
SOLVE-TAVI is a multicentre, open-label, 2 × 2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral TAVI comparing SEV (Evolut R, Medtronic Inc., Minneapolis, MN, USA) with BEV (Sapien 3, Edwards Lifesciences, Irvine, CA, USA). The primary efficacy composite endpoint of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days was powered for equivalence (equivalence margin 10% with significance level 0.05). The primary composite endpoint occurred in 28.4% of SEV patients and 26.1% of BEV patients meeting the prespecified criteria of equivalence rate difference −2.39 (90% confidence interval, CI −9.45 to 4.66); Pequivalence = 0.04. Event rates for the individual components were as follows: all-cause mortality 3.2% vs. 2.3% rate difference −0.93 (90% CI −4.78 to 2.92); Pequivalence < 0.001, stroke 0.5% vs. 4.7% rate difference 4.20 (90% CI 0.12 to 8.27); Pequivalence = 0.003, moderate/severe paravalvular leak 3.4% vs. 1.5% rate difference −1.89 (90% CI −5.86 to 2.08); Pequivalence = 0.0001, and permanent pacemaker implantation 23.0% vs. 19.2% rate difference −3.85 (90% CI −10.41 to 2.72) in SEV vs. BEV patients; Pequivalence = 0.06.
Conclusion
In patients with aortic stenosis undergoing transfemoral TAVI, newer generation SEV and BEV are equivalent for the primary valve-related efficacy endpoint. These findings support the safe application of these newer generation percutaneous valves in the majority of patients with some specific preferences based on individual valve anatomy.
The authors sought to determine: 1) the global arrhythmic burden; 2) the rate of arrhythmias leading to a treatment change; and 3) the incidence of high-degree atrioventricular block (HAVB) at ...12-month follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR).
Controversial data exist on the occurrence of significant arrhythmias in patients with LBBB post-TAVR.
This was a multicenter prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR with the balloon-expandable SAPIEN XT/3 valve (n = 53), or the self-expanding CoreValve/Evolut R system (n = 50). An implantable cardiac monitor (Reveal XT, Reveal Linq) was implanted at 4 (3 to 6) days post-TAVR, and patients had continuous electrocardiogram monitoring for 12 months. All arrhythmic events were adjudicated in a central electrocardiography core lab. Primary endpoints were the incidence of arrhythmias leading to a treatment change, and the incidence of HAVB at 12-month follow-up.
A total of 1,553 new arrhythmic events were detected in 44 patients (1,443 episodes of tachyarrhythmia in 26 patients atrial fibrillation/flutter/atrial tachycardia: 1,427, ventricular tachycardia 16; 110 episodes of bradyarrhythmia in 21 patients HAVB 54, severe bradycardia 56). All arrhythmic events were silent in 34 patients (77%), the arrhythmic event led to a treatment change in 19 patients (18%), and 11 patients (11%) required pacemaker or implantable cardioverter-defibrillator implantation (due to HAVB, severe bradycardia, or ventricular tachycardia episodes in 9, 1, and 1 patient, respectively). A total of 12 patients died at 1-year follow-up, 1 from sudden death.
A high incidence of arrhythmic events was observed at 1-year follow-up in close to one-half of the patients with LBBB post-TAVR. Significant bradyarrhythmias occurred in one-fifth of the patients, and PPM was required in nearly one-half of them. These data support the use of a cardiac monitoring device for close follow-up and expediting the initiation of treatment in this challenging group of patients. (Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation MARE study: NCT02153307).
Background
It is inevitable for patients to have a temporary or permanent pacemaker implanted during or after radiofrequency catheter ablation (RFCA) for treatment of atrial fibrillation (AF) in some ...cases. The aim of our study was to evaluate the incidence of pacemaker implantation (PMI) during or within 3 months of RFCA for AF and to identify the risk factors that were associated with PMI.
Methods
We performed a retrospective analysis of consecutive AF patients who underwent RFCA between August 2018 and October 2020 at our center. The incidence of PMI within 3 months during or after RFCA were assessed. A multivariate logistic regression model was performed to identify predictors of PMI.
Results
One thousand and five patients (mean age, 60.2 ± 10.3 years; 37.6% women) were included in this analysis. PVI was performed in all patients. A total of 23 (2.3%) patients had a pacemaker implanted within 3 months during or after ablation. Multivariable logistic regression analysis revealed that older age (OR: 1.08 95% CI 1.03‐1.13, p = .003), female sex (OR: 3.08 95% CI 1.28‐7.45, p = .012), paroxysmal AF (OR: 4.71 95% CI 1.09‐20.45, p = .038) and repeated ablation (OR: 2.78 95% CI 1.04‐7.40, p = .041) were the independent predictors for PMI.
Conclusions
Older age, female sex, paroxysmal AF and repeated ablation were identified as predictive risk factors for PMI after RFCA in patients with AF. A "watch and wait" strategy could be taken for patients with temporary PMI after ablation, especially for those with prolonged sinus pause after AF termination.
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.
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