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•Pacemaker implantation is a major issue of transcatheter aortic valve implantation.•Membranous septum length stratified the risk in right bundle branch block cohort.•High implantation could prevent pacemaker implantation even in the high-risk subset. Preexisting right bundle branch block (RBBB) is the strongest predictor for permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI). However, the risk assessment for new PPI and effective procedural strategy for preventing new PPI in patients with preexisting RBBB are still unclear. This study stratified the new PPI risk after TAVI and investigated the impact of implantation strategy in a preexisting RBBB cohort. We analyzed 237 patients with preexisting RBBB who underwent TAVI. The primary endpoint was the incidence of new PPI. Multivariate analyses investigating predictors for new PPI were performed. The overall PPI rate was 33.3%. Significant baseline predictors for new PPI were combination of RBBB, left anterior or posterior fascicular block, and first-degree atrioventricular block (odds ratio [OR] 2.55, 95% confidence interval [CI] 1.09 to 5.04), high calcium volume of noncoronary cusp (OR 2.08, 95% CI 1.05 to 4.10), and membranous septum (MS) length <2 mm (OR 2.02, 95% CI 1.09 to 3.75) in the univariate analysis and MS length <2 mm (OR 2.25, 95% CI 1.06 to 4.82) in the multivariate analysis. On the multivariate analysis including procedural variables, predilatation (OR 2.41, 95% CI 1.01 to 5.83), self-expanding valves (Corevalve, Evolut R, and Evolut Pro/Pro+; Medtronic Inc., Minneapolis, Minnesota) or mechanical expanding valves (Lotus/Lotus Edge; Boston Scientifics, Marlborough, Massachusetts) (OR 3.00, 95% CI 1.31 to 6.91), and implantation depth > MS length (OR 4.27, 95% CI 1.81 to 10.08) were significantly associated with new PPI. The incidence of new PPI increased according to the number of baseline predictors (0: 20.9%, 1: 34.3%, and ≥2: 52.0%) and procedural predictors (0: 3.7%, 1: 20.9%, 2: 40.5%, and 3: 60.0%). New PPI risk in a preexisting RBBB subset could be stratified by baseline factors. Device selection and implantation strategy considering MS length could prevent new PPI even in these high-risk population.

Currently, permanent pacemaker implantation (PPMI) is the most common complication of transcatheter aortic valve implantation (TAVI). The aim of this analysis is to develop a simple and effective risk prediction model for PPMI within 30 days of TAVI. Data from 370 patients who underwent TAVI with the self-expanding valve between February 2015 and June 2022 at our center were collected in the development cohort (DC). A risk score was developed based on baseline anatomical and electrocardiographic characteristics, including the estimation of aortic calcium load (ACL) using both the Agatston score and calcium volume. A validation cohort (VC) of 234 patients was used to test the score. Seventy-two patients (19.5%) underwent PPMI in DC. Preprocedural right bundle branch block (RBBB), membranous septum length (MSL) <5 mm, and severe ACL were significant predictors of PPMI. The Agatston score showed higher agreement with PPMI compared to calcium volume (K = 0.89; 95% CI 0.84 to 0.93 vs K = 0.71; 95% CI 0.64 to 0.79, respectively). Pre-existing RBBB, MSL, and Agatston score have been combined into a simple score, called RITMO (theoretical range from −1 to 4 points). We applied the score to the VC and find that a high score (>1) had an OR>6 to predict PPMI after TAVI. In patients undergoing TAVI with a self-expanding valve, baseline RBBB, shorter MSL, and higher ACL evaluated using the Agatston method were predictive of 30-day PPMI. In conclusion, the RITMO score represents a simple tool for risk stratification, with implications for procedural planning and patient counseling. [Display omitted]

New-generation transcatheter heart valves have significantly improved technical success and procedural safety of transcatheter aortic valve implantation (TAVI) procedures; however, the incidence of permanent pacemaker implantation (PPI) remains a concern. This study aimed to assess the role of anatomic annulus features in determining periprocedural conduction disturbances leading to new PPI after TAVI using the last-generation Edwards SAPIEN balloon-expandable valves. In the context of a prospective single-center registry, we integrated the clinical and procedural predictors of PPI with anatomic data derived from multislice computed tomography. A total of 210 consecutive patients treated with balloon-expandable Edwards transcatheter heart valve were included in the study from 2015 to 2023. Technical success was achieved in 197 procedures (93.8%), and 26 patients (12.4%) required new PPI at the 30-day follow-up (median time to implantation 3 days). At the univariable logistic regression analysis, preprocedural right bundle branch block (odds ratio [OR] 2.24, 95% confidence interval [CI] 1.01 to 4.97, p = 0.047), annulus eccentricity ≥0.25 (OR 5.43, 95% CI 2.21 to 13.36, p <0.001), calcium volume at annulus of the right coronary cusp >48 mm3 (OR 2.60, 95% CI 1.13 to 5.96, p = 0.024), and prosthesis implantation depth greater than membranous septum length (OR 2.17, 95% CI 1.10 to 4.28, p = 0.026) were associated with new PPI risk. In the multivariable analysis, preprocedural right bundle branch block (OR 2.81, 95% CI 1.01 to 7.85, p = 0.049), annulus eccentricity ≥0.25 (OR 4.14, 95% CI 1.85 to 9.27, p <0.001), and annulusright coronary cusp calcium >48 mm3 (OR 2.89, 95% CI 1.07 to 7.82, p = 0.037) were confirmed as independent predictors of new PPI. In conclusion, specific anatomic features of the aortic valve annulus might have an additive role in determining the occurrence of conduction disturbances in patients who underwent TAVI with balloon-expandable valves. This suggests the possibility to use multislice computed tomography to improve the prediction of post-TAVI new PPI risk. [Display omitted]

PurposeThis study sought to identify risk factors for permanent pacemaker implantation (PPMI) after Transcatheter aortic valve implantation (TAVI) and explain their trends over the last decade. TAVI is performed nowadays for severe aortic stenosis in more patients with lower surgical risk. While most TAVI complications have been reduced, PPMI remains common.MethodsIn this observational, retrospective cohort analysis, 338 TAVI patients treated between 2008 and 2017 were reviewed. Risk factors were compared between the early (2008–2013) and late years (2014–2017), and a multivariable logistic regression model was used.ResultsA decreasing trend in PPMI over time was observed (p for trend = 0.008), as was a lower rate of PPMI in the late period (19.3% vs. 31.7%, p = 0.009). Three variables were identified as independent risk factors for PPMI that also decreased significantly in the late period: valve implantation depth ≥ 8 mm (OR = 4.3, 95% CI 2.3–8.2, p < 0.001), use of self-expandable valves (OR = 2.8, 95% CI 1.4–5.5, p = 0.004), and patient risk assessed by EuroSCORE II (OR = 1.07, 95% CI 1.0–1.1, p = 0.034). Indications for PPMI were also shown to change over time, with an increase in the prevalence of complete AVB as the main indication for PPMI (p = 0.048), and a trend towards a decrease in LBBB alone (p = 0.061).ConclusionsThe decrease in post-TAVI PPMI over the past decade is multifactorial and can be explained by (1) lower baseline patient surgical risk, (2) modified procedural variables including decreased implantation depth and increased use of balloon-expandable valves, and (3) refined indications for PPMI.

Background Patients undergoing a transcatheter aortic valve implantation (TAVI) are at risk for Major Adverse Cardiac Events (MACE). We describe temporal trends of TAVI-related MACEs, stratified by age and sex. Methods We performed a retrospective analysis of TAVI patients from the Netherlands Heart Registration (NHR) between 2013 and 2022. The outcomes were: mortality at 30 days, mortality at one year, permanent pacemaker implantation at 30 days (PPI), major vascular complication at 30 days (MVC), and stroke at three days. We calculated incidence and trends in TAVI patients and their outcomes. Results The cohort consisted of 19,746 TAVI patients, with a mean age of 80 years. The annual number of TAVI procedures increased over the years from 786 to 2876 ( p  < 0.001). Initially, more women received TAVI, but the trend shifted over time to more men ( p  < 0.001). Outcomes incidence was: 30-day mortality (3.3%), one-year mortality (10.6%), PPI (10.7%), MVC (2.9%), and stroke (2.0%). Incidence of both mortality outcomes decreased over time (6.7% to 2.7%, and 15.8% to 8.8% for 30-day and one-year mortality, respectively), as did PPI (12.3% to 10.4%) and MVC (3.6% to 2.5%). Women had a higher incidence of MVC and stroke. Men had a higher incidence of one-year mortality and PPI, and their incidence increased more with age than it did in women. Conclusion The volume of TAVI procedures has increased significantly over time, while mortality, PPI, MVC, and MACE incidence have significantly decreased. Sex-specific differences in MACE outcome incidence were present.

Background Predictors for the need of permanent pacemaker implantation (PPMI) in the context of transcatheter aortic valve implantation (TAVI) are not well defined yet. We evaluated the impact of conduction disturbances, calcium volume of the device landing zone, oversizing and implantation depth on PPMI after TAVI with the balloon-expandable Edwards Sapien 3 (ES3). Methods and results 335 consecutive patients undergoing transfemoral TAVI with the ES3 for the treatment of symptomatic severe aortic stenosis were included (clinicaltrials NCT02162069). Rate of PPMI after TAVI was 18.4%, excluding patients with permanent pacemakers prior to TAVI or valve-in-valve implantations. Patients requiring PPMI more often had first degree atrioventricular block (AVB) at baseline (48.7 vs. 16.5%, p  < 0.01), preprocedural complete right bundle branch block (RBBB; 25.0 vs. 3.9%, p  < 0.01) and higher calcium volume of the aortic valve (258.5 ± 317.3 vs. 163.6 ± 178.8 mm³, p  < 0.01). There was a trend towards higher rate of PPMI in patients with new-onset left bundle branch block after TAVI (32.7 vs. 20.7%, p  = 0.06). Multivariate logistic regression analysis showed that baseline first degree AVB (odds ratio 3.9, 95% confidence interval 1.73–9.10, p  < 0.01) and preprocedural complete RBBB (odds ratio 4.5, 95% confidence interval 1.50–13.21, p  < 0.01) were independent predictors of PPMI. Of note, neither oversizing nor implantation depth were independent predictors for need of PPMI with the ES3. Conclusions In patients treated with the ES3 for symptomatic severe aortic stenosis first degree AVB and complete RBBB at baseline were independently associated with higher rates of postprocedural PPMI, whereas implantation depth and oversizing did not have an impact on PPMI.

PurposeConduction defects requiring permanent pacemaker insertion (PPI) are one of the most common complications after transcatheter aortic valve implantation (TAVI). The purpose of this study was to identify the incidence and predictors of this complication as well as to assess clinical outcomes of patients requiring PPI after TAVI in an Arab population.MethodsIn this single-center, retrospective cohort analysis, all patients who underwent TAVI from 2010 to 2018 were reviewed; seventy-four independent variables were collected per patient, and multivariate analysis was performed to identify predictors. In-hospital outcomes were examined as well as 30-day and 1-year endpoints as defined by the Valve Academic Research Consortium-2.ResultsThere were 48 of 170 patients (28.2%) who required PPI within 30 days of TAVI. The median time from TAVI to PPI was 2 days (interquartile range: 0 to 5 days). Positive predictors of 30-day PPI were prior right bundle branch block (odds ratio [OR]: 4.10; 95% confidence interval [CI]: 0.37 to 0.79; p < 0.001), post-procedural development of new right bundle branch block (OR: 3.59; 95% CI: 1.07 to 12.03; p = 0.038), post-procedural development of new left bundle branch block (LBBB) (OR: 1.85; 95% CI: 1.21 to 2.84; p = 0.005), post-procedural prolongation of PR interval (OR: 1.02; 95% CI: 1.01 to 1.02; p < 0.001), and post-procedural QRS duration (OR: 1.01; 95% CI: 1.00 to 1.03; p = 0.02). However, post-procedural development of new LBBB no longer remained a significant predictor of PPI after excluding six patients with LBBB who underwent prophylactic PPI (p = 0.093). Negative predictors of 30-day PPI were the presence of diabetes (OR: 0.54; 95% CI: 037 to 0.79; p = 0.001), the use of prosthesis size 29 compared to 23 (OR: 0.55; 95% CI: 0.35 to 0.87; p = 0.010), and the use of prosthesis size 26 compared to 23 (OR: 0.31; 95% CI: 0.20 to 0.50; p < 0.001). PPI was associated with longer median hospital stay, but the result was borderline significant after multivariate adjustment (19 vs. 14 days; p = 0.052). There was no statistically significant difference in 30-day and 1-year clinical outcomes.ConclusionOne-third of patients required PPI after TAVI. Several risk factors can identify patients at risk for PPI particularly pre-existing right bundle branch block. Further studies are needed to assess the association between PPI and negative clinical outcomes.

Background: Patients with end-stage renal disease (ESRD) are at elevated risk for device-related complications following pacemaker implantation. Leadless pacemakers (LPMs) offer theoretical advantages over transvenous pacemakers (TVPs), but their safety and efficacy in this high-risk population remain unclear. Our aim was to compare clinical outcomes and complication profiles between leadless and transvenous pacemakers in patients with ESRD. Methods: We conducted a systematic review and meta-analysis according to PRISMA guidelines, including three retrospective studies comparing LPMs and TVPs in ESRD patients. The primary endpoint was overall complications post-implantation. Secondary outcomes included early mortality (within 30 days), access site complications, device-related events, thrombotic events, and respiratory complications. A random-effects model was used to pool odds ratios (ORs) and 95% confidence intervals (CIs). Results: Three studies comprising 10.075 ESRD patients were included. No significant difference was found in overall complications (OR 1.35, 95% CI 0.78–2.33, p = 0.14) or early mortality (OR 1.01, 95% CI 0.42–2.43, p = 0.97) between LPM and TVP groups. However, LPMs were associated with increased access site complications (OR 2.51, 95% CI 1.06–5.90, p = 0.04), thrombotic events (OR 1.42, 95% CI 1.14–1.78, p = 0.03), and respiratory complications (OR 1.43, 95% CI 1.01–2.03, p = 0.05). Device-related complication rates were similar (OR, 1.09; 95% CI, 0.63–1.88; p = 0.30). Heterogeneity was low across most outcomes. Conclusions: Among patients with ESRD, leadless pacemakers did not reduce overall complications or short-term mortality compared to transvenous systems and were associated with increased risk of certain procedural complications. These findings could support a personalized approach to device selection in ESRD and highlight the need for further prospective studies to guide clinical decision-making in this population.

AimsTo identify predictors of paravalvular regurgitation (PVR) and permanent pacemaker implantation (PPI) following TAVR with a next-generation self-expanding device.Methods and resultsDevice landing zone (DLZ) calcification, angiographic implantation depth, and baseline and procedural characteristics were analyzed in 212 patients being treated with the ACURATE neo aortic bioprosthesis. PVR was none/trace in 57.1% and ≥ mild in 42.9% (37% mild, 6% moderate). DLZ calcification (705 (IQR 240–624) vs. 382 (IQR 240–624) mm3; P < 0.001) as well as absolute calcium asymmetry (233 ± 159 vs. 151 ± 151 mm3; P < 0.001) was significantly higher in patients with PVR ≥ mild. On multivariate analysis, calcification of the aortic valve cusps (AVC) > 410.6 mm3 was independently associated with PVR ≥ mild. PPI rate was 10.3% (n = 20). Patients with and without need for PPI had similar total DLZ calcium volume (740 (IQR 378–920) vs. 536 (IQR 315–822) mm3; P = 0.263), but exhibited different calcium distribution patterns: LVOT calcium > 41.4 mm3 in the sector below the left coronary cusp (LVOTLC) was associated with increased PPI risk (26.9 vs. 7.7%; P = 0.008).ConclusionsThe quantity of AVC calcium predicts residual PVR. Multivariable analysis identified LVOTLC calcium, pre-existing RBBB, and age > 82.7 years as independent predictors of PPI. Based on these risk factors, a patient’s individual PPI risk can be stratified ranging from 3.8 to 100%.

Background The association of postimplant tricuspid regurgitation (TR) and heart failure (HF) hospitalization in patients without HF and preexisting abnormal TR and TR pressure gradient (PG) remain unclear. Hypothesis This study aimed to explore the clinical outcomes of progressive postimplant TR after permanent pacemaker (PPM) implantation. Methods A total of 1670 patients who underwent a single ventricular or dual‐chamber transvenous PPM implantation at our hospital between January 2003 and December 2017 were included in the study. Patients with prior valvular surgery, history of HF, and baseline abnormal TR and TRPG were excluded. Finally, a total of 1075 patients were enrolled in this study. Progressive TR was defined as increased TR grade of ≥2 degrees and TRPG of >30 mmHg after implant. Results In 198 (18.4%) patients (group 1) experienced progressive postimplant TR and elevated TRPG, whereas 877 patients (group 2) did not have progressive postimplant TR. Group 1 had larger change in postimplant TRPG (group 1 vs. group 2; 12.8 ± 9.6 mmHg vs. 1.1 ± 7.6 mmHg; p < .001) than group 2. Group 1 had a higher incidence of HF hospitalization compared to group 2 (13.6% vs. 4.7%; p < .001). Preimplant TRPG (HR: 1.075; 95% confidence interval [CI]: 1.032–1.121; p = .001) was an independent predictor of progressive postimplant TR. Conclusions After a transvenous ventricular‐based PPM implantation, 18.4% of patients experienced progressive postimplant TR and elevated TRPG. Higher preimplant TRPG was an independent predictor of progressive postimplant TR.