30-day Permanent Pacemaker Implantation Research Articles

National Variability in Pacemaker Implantation Rate Following TAVR: Insights From the STS/ACC TVT Registry

BackgroundAlthough permanent pacemaker (PPM) implantation is a common complication of transcatheter aortic valve replacement (TAVR), hospital variation and change in PPM implantation rates are ill defined. ObjectivesThe aim of this study was to determine hospital-level variation and temporal trends in the rate of PPM implantation following TAVR. MethodsUsing the American College of Cardiology/Society of Thoracic Surgeons TVT (Transcatheter Valve Therapy) Registry, temporal changes in variation of in-hospital and 30-day PPM implantation were determined among 184,452 TAVR procedures across 653 sites performed from 2016 to 2020. The variation in PPM implantation adjusted for valve type by annualized TAVR volume was determined, and characteristics of sites below, within, and above the 95% boundary were identified. A series of stepwise multivariable hierarchical models were then fit, and the median OR was used to measure variation in pacemaker rates among sites. ResultsFrom 2016 to 2020, the overall rate of PPM implantation was 11.3%, with wide variation across sites (range: 0%-36.4%); rates trended lower over time. Adjusted for annualized volume, there were 34 sites with PPM implantation rates above the 95th percentile CI and 28 with rates below, with wide variation among the remaining sites. After adjusting for patient-level covariates, there was variation among sites in the probability of PPM implantation (median OR: 1.39; 95% CI: 1.35-1.43, P < 0.001); although some of the variation was explained by the addition of valve type, residual variation in PPM implantation rates persisted in additional models incorporating site-level covariates (annualized volume, region, teaching status, hospital beds, etc). ConclusionsAlthough PPM implantation rates have decreased over time, substantial site-level variation remains even after accounting for observed patient characteristics and site-level factors. As there are numerous outlier sites both above and below the 95% confidence limit, dissemination of best practices from high-performing sites to low-performing sites and guideline-based education may be important quality improvement initiatives to reduce rates of this common complication.

Impact of Transjugular Intracardiac Echocardiography-Guided Self-Expandable Transcatheter Aortic Valve Implantation on Reduction of Conduction Disturbances.

A high permanent pacemaker implantation (PPI) risk remains a concern of self-expandable transcatheter aortic valve implantation, despite the continued improvements in implantation methodology. We aimed to assess the impact of real-time direct visualization of the membranous septum using transjugular intracardiac echocardiography (ICE) during transcatheter aortic valve implantation on reducing the rates of conduction disturbances including the need for PPI. Consecutive patients treated with Evolut R and Evolut PRO/PRO+ from February 2017 to September 2022 were included in this study. We compared outcomes between the conventional implantation method using the 3-cusps view (3 cusps without ICE group), the recent method using cusp-overlap view (cusp overlap without ICE group), and our novel method using ICE (cusp overlap with ICE group). Of the 446 patients eligible for analysis, 211 (47.3%) were categorized as the 3 cusps without ICE group, 129 (28.9%) were in the cusp overlap without ICE group, and 106 (23.8%) comprised the cusp overlap with ICE group. Compared with the 3 cusps without ICE group, the cusp overlap without ICE group had a smaller implantation depth (2.2 [interquartile range, 1.0-3.5] mm versus 4.3 [interquartile range, 3.3-5.4] mm; P<0.001) and lower 30-day PPI rates (7.0% versus 14.2%; P=0.035). Compared with the cusp overlap without ICE group, the cusp overlap with ICE group had lower 30-day PPI rates (0.9%; P=0.014), albeit with comparable implantation depths (1.9 [interquartile range, 0.9-2.9] mm; P=0.150). Multivariable analysis showed that our novel method using ICE with the cusp-overlap view was independently associated with a 30-day PPI rate reduction. There were no group differences in 30-day all-cause mortality (1.4% versus 1.6% versus 0%; P=0.608). Our novel implantation method using transjugular ICE, which enable real-time direct visualization of the membranous septum, achieved a predictably high position of prostheses, resulting in a substantial reduction of conduction disturbances requiring PPI after transcatheter aortic valve implantation.

Clinical Impact of Standardized TAVR Technique and Care Pathway: Insights From the Optimize PRO Study

BackgroundProcedural 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. ObjectivesThe 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. MethodsOptimize 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. ResultsA 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. ConclusionsThe 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)

Early and midterm outcomes of transcatheter aortic-valve replacement with balloon-expandable versus self-expanding valves: A meta-analysis

BackgroundCurrent guidelines provide recommendation for transcatheter aortic-valve replacement (TAVR) in severe aortic stenosis without emphasis on valve systems. The comparative performances of balloon-expandable valves (BEV) and self-expanding valves (SEV) remain unclear. We aim to compare the early (30-day) and midterm (1-year) mortality and cardiovascular outcomes of BEV with SEV. MethodsPubMed, CENTRAL, and EMBASE were searched from inception to February 13, 2020 for randomized controlled trials (RCTs) and propensity-score matched (PSM) studies. Odds ratios (ORs) for binary outcomes and mean differences for continuous outcomes were pooled using random-effect models (DerSimonian–Laird method) with Hartung-Knapp-Sidik-Jonkman variance correction. Primary outcomes were early and midterm all-cause mortality. ResultsWe included 3 RCTs (1418 patients) and 12 PSM studies (36,540 patients). Compared with SEV, BEV was associated with significantly lower mortality at 30 days (OR 0.76, 95% CI 0.67–0.85, p < 0.001, I2 = 0) and 1 year (OR 0.87, 95% CI 0.77–0.99, p = 0.04, I2 = 20.4%) in PSM studies, but not RCTs with insufficient power. Similar findings were found in subgroups analysis based on valve generations and SEV types. The 30-day and 1-year cardiovascular mortality, 30-day incidences of moderate to severe paravalvular leak, procedural contrast agent volume, and procedure time were lower, but transvalvular pressure gradient was higher in BEV than SEV in PSM studies. The 30-day incidences of permanent pacemaker implantation (PPI), acute kidney injury, stroke, major bleeding, major vascular complications, and rehospitalization were not statistically different between BEV and SEV. Early-generation SEV was associated with a higher 30-day PPI risk than corresponding BEV comparators. PPI risk was lower in ACURATE neo (Boston Scientific, Natick, MA) but higher in Evolut R SEV (Medtronic Inc., Minneapolis, MN), both compared with SAPIEN 3 BEV (Edwards Lifesciences, Irvine, CA). ConclusionsPSM studies suggest lower early and midterm mortality in BEV than SEV, but the contribution of unmeasured confounders cannot be excluded. Results from adequately powered RCTs with long-term follow-up are critically needed to confirm these findings.

Reframing Optimal Implantation of the Sapien 3 Transcatheter Heart Valve.

To define the optimal implantation of the Sapien 3 (Edwards Lifesciences) transcatheter heart valve (THV), this study systematically analyzed the predeployment fluoroscopic THV position and correlated this to clinical outcomes. This was an observational study of 279 patients treated with the Sapien 3 THV. Fluoroscopic imaging was used to categorize patients into low (n = 147), intermediate (n = 86), and high (n = 46) implantation zones. These zones were based on the relationship of the balloon marker and radiolucent line of the valve frame (line of lucency) to the annular plane at deployment. The primary outcome was the rate of permanent pacemaker implantation (PPI) at 30 days. The secondary outcomes were the rates of new left bundle-branch block (LBBB) in-hospital and all-cause mortality at 1 year. In the high, intermediate, and low groups, 30-day PPI rates were 4.3%, 8.1%, and 8.8% (P=.62); in-hospital LBBB rates were 10.9%, 26.7%, and 32.0% (P=.02); and all-cause mortality rates at 1 year were 3.1%, 7.3%, and 12.5% (P=.14), respectively. No differences were observed with respect to procedural success/complications or THV performance between the groups. This study demonstrates fewer conduction abnormalities for Sapien 3 valves positioned within a higher zone defined fluoroscopically by the line of lucency and balloon marker.

Effect of Radiolucent Line-Guided Balloon-Expandable Transcatheter Aortic Valve Implantation on Subsequent Pacemaker Rate

In the era of expanding transcatheter aortic valve implantation (TAVI) indications for low surgical risk patients, conduction disturbances requiring permanent pacemaker implantation (PPI) after TAVI remain a serious concern. We aimed to assess the impact of the radiolucent line-guided technique for the SAPIEN 3 implantation on reducing the rates of new-onset PPI after TAVI. A total of 326 patients treated with the SAPIEN 3 using either the radiolucent line-guided technique (lucent group, 170 patients [52.1%]) or the center marker-guided technique (conventional group, 156 patients [47.9%]) were prospectively included in our database. The prosthesis position, and 30-day and 3-year clinical outcomes were retrospectively assessed. Compared with the conventional group, the lucent group had a higher prosthesis position (1.7 ± 0.9mm vs 4.2±1.5mm, p <0.001) and lower 30-day PPI rates (2.9% vs 13.5%, p <0.001). The other periprocedural complications including valve dislodgement and coronary obstruction, and 30-day and 3-year mortality were comparable between the groups. However, the prosthesis frame extending above sinotubular junction was more frequently observed in the lucent group on the side of left coronary sinus (53.4% vs 31.4%, p <0.001) and right coronary sinus (35.0% vs 20.2%, p=0.001), signifying a potential risk for "subsequent difficulties to access coronary ostia" and "coronary obstruction during future redo TAVI." In conclusion, the radiolucent line-guided technique predictably provided an extremely high position of the SAPIEN 3, reducing the postprocedural PPI rates compared with the center marker-guided technique.

Identifying predictive risk factors for permanent pacemaker implantation up to 30 days post-TAVI

Abstract Background Conduction system abnormalities, including AV block, are amongst the most common complications of transcatheter aortic valve implantation (TAVI). Post-TAVI high degree AV block necessitates permanent pacemaker (PPM) implantation. Purpose To assess the ability of standardly available pre-, intra- and post-TAVI factors to predict PPM implantation within 30-days post procedure. Methods Demographic and clinical (pre-, intra-, and post-procedural) data including ECG parameters were collected from all patients who underwent TAVI at our centre from August 2017 to November 2020. Patients with pre-existing PPM were excluded from the study. Predictive factors were selected through univariate analysis, and selected characteristics were incorporated into a multivariate binomial logistic regression model, in order to create a 30-day PPM risk-prediction model. The Akaike information criterion (AIC) and area under receiver operating curve (AUC/C-statistic) were used to assess discriminative performance. Results In total, data from a total of 446 patients were analysed. Of these, 40 (8.97%) received PPM implantation within 30 days of the procedure. The mean age of the patients was 81.5 (±7.3 SD) years; 99 (22.2%) had pre-existing first degree AV block, 55 (12.3%) had pre-existing left bundle branch block (LBBB) and 50 (11.2%) had pre-existing right bundle branch block (RBBB). Intra-procedurally 40 (9.0%) developed LBBB, 21 (4.7%) developed 3rd degree AV block, and 95 (21.3%) patients required temporary pacing wire (TPW) pacing. Post-procedurally, 138 (30.9%) exhibited AV block, 107 (24.0%) LBBB and 50 (11.2%) RBBB. The following factors met significance at multivariate logistic regression analysis: pre-TAVI RBBB (OR 6.62 [95% CI, 1.37–36.51]), intra-TAVI 3rd degree AV block (OR 12.80 [95% CI, 3.44–53.34]), intra-TAVI LBBB (OR 4.02 [95% CI, 1.28–12.53]), use of TPW pacing (OR 8.58 [95% CI, 3.19–25.12]) and post-TAVI LBBB (OR 7.84 [95% CI, 2.75–24.46]) (Table). Finally, variables were incorporated into a multivariate logistic regression model with the outcome variable of 30-day PPM implantation (Figure 1a). A model incorporating five factors (pre-TAVI RBBB, intra-TAVI 3rd degree AV block, intra-TAVI LBBB, use of TPW pacing and post-TAVI LBBB) demonstrated excellent discriminative ability (accuracy 0.925 and an AUC of 0.952) at predicting PPM implantation (Figure 1b). Conclusions Following variable selection, the best performing model incorporated five factors including pre-TAVI RBBB, intra-TAVI AV block (3rd degree), intra-TAVI LBBB, use of TPW pacing and post-TAVI LBBB. We aim to validate this model using an external cohort. Funding Acknowledgement Type of funding sources: None. Table 1Figure 1

Impact of Predilatation Prior to Transcatheter Aortic Valve Implantation With the Self-Expanding Acurate neo Device (from the Multicenter NEOPRO Registry)

Safety and feasibility of transfemoral Acurate neo implantation without systematic predilatation are not fully investigated. Our aim was to evaluate the use and impact of pre-implantation balloon aortic valvuloplasty (pre-BAV) before transcatheter aortic valve implantation (TAVI) with Acurate neo. The NEOPRO Registry retrospectively included 1,263 patients who underwent transfemoral TAVI with Acurate neo at 18 centers between January 2012 and March 2018. Information on pre-BAV was available for 1,262 patients (99.9%). Primary end points were pre-discharge moderate-to-severe paravalvular aortic regurgitation (PAR II+), 30-day new permanent pacemaker implantation, and 30-day all-cause mortality or stroke. A total of 1,262 patients who underwent TAVI with (n = 1,051) or without predilatation (n = 211) were included. A reduction in the pre-BAV rate was observed during the study period (from 95.7% in the first date quintile to 78.4% in the last date quintile). Patients who underwent pre-BAV had higher degrees of aortic valve (AV) and left ventricular outflow tract (LVOT) calcification. Primary endpoints were similar between pre-BAV and no pre-BAV groups (PAR II+ 5.5% vs 3.4%, p = 0.214; 30-day permanent pacemaker implantation 9.0% vs 8.0%, p = 0.660; 30-day death or stroke 4.9% vs 4.4%, p = 0.743). The need for postdilatation and other procedural outcomes were comparable between groups. Predilatation did not have a significant impact on primary endpoints across AV and LVOT calcification subgroups (subgroup analyses) and was not independently associated with primary endpoints (multivariate analyses). In conclusion, transfemoral Acurate neo implantation without predilatation appears to be feasible and safe, especially in patients with milder degrees of AV and LVOT calcification.

P5978Mechanical dispersion is a predictor of 30-day permanent pacemaker implantation after transcatheter aortic valve replacement

Abstract Background Transcatheter aortic valve replacement (TAVR) related conduction disturbance resulting in permanent pacemaker (PPM) implantation is a common complication. The mechanical effects of these conduction abnormalities can be measured as regional heterogeneity of contraction by myocardial strain imaging. Objectives The aim of this study was to investigate whether post-TAVR left ventricular mechanical dispersion (MD) can predict PPM implantation. Methods We retrospective analyzed 137 patients (48% men, 80±9 years) who underwent TAVR at our institution after excluding patients with pre-existing PPM. 2D speckle-tracking echocardiography was used to assess MD (SD of time from Q/R on the ECG to peak strain in 16 LV segments) immediately after TAVR (median, 1 day). Images were analyzed offline using a vendor-independent software (TomTec). Results At 30-days post-TAVR, 14 (10.2%) patients underwent PPM implantation. Patients requiring PPM had more pronounced MD (p=0.012), pre-existing RBBB (p=0.017), pre-existing LAHB (p&lt;0.001), and peri-procedural AVB (p=0.005). Multivariate Cox regression analysis of important clinical covariates (model 1 = age, sex, RBBB, LAHB, AVB) showed significant predictive value for PPM implantation (chi-square 41.8, p&lt;0.001). Addition of MD to the model resulted in a significant chi-square increase (from 41.8 to 47.3, p=0.01). Conclusion Left ventricular MD, measured immediately after TAVR, was associated with 30-day PPM and provided incremental predictive value to important clinical variables.

Transcatheter Valve SELECTion in Patients With Right Bundle Branch Block and Impact on Pacemaker Implantations

ObjectivesThis study sought to evaluate the impact of the ACURATE neo (NEO) (Boston Scientific, Marlborough, Massachusetts) versus SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) on permanent pacemaker implantation (PPI) in patients with pre-existing right bundle branch block (RBBB) after transcatheter aortic valve replacement. BackgroundPre-existing RBBB is the strongest patient-related predictor for PPI after transcatheter aortic valve replacement. No comparison of newer-generation transcatheter heart valves with regard to PPI in these patients exists. MethodsThis multicenter registry includes 4,305 patients; 296 (6.9%) had pre-existent RBBB and no pacemaker at baseline and formed the study population. The primary endpoint was new PPI at 30 days. The association of NEO versus S3 with PPI was assessed using binary logistic regression analyses and inverse probability treatment weighting in a propensity-matched population. ResultsThe 30-day PPI rate was 39.2%. The S3 and NEO were used in 66.9% and 33.1%, respectively. The NEO was associated with lower rates of PPI compared with the S3 (29.6% vs. 43.9%; p = 0.025; odds ratio [OR]: 0.54; 95% confidence interval [CI]: 0.32 to 0.89; p = 0.018), after multivariable adjustment (OR: 0.48; 95% CI: 0.26 to 0.86; p = 0.014), and in the inverse probability treatment weighting analysis (OR: 0.37; 95% CI: 0.25 to 0.55; p < 0.001). There was no difference in device failure (8.2% vs. 6.6%; p = 0.792) or in-hospital course. In the propensity-matched population, PPI rate was also lower in the NEO versus S3 (23.1% vs. 44.6%; p = 0.016; OR: 0.37; 95% CI: 0.17 to 0.78; p = 0.010), with no difference in device failure (9.2% vs. 6.2%; p = 0.742). ConclusionsIn patients with RBBB, risk of PPI was significantly lower with the NEO compared with the S3, suggesting the possibility of a patient tailored transcatheter heart valve therapy.

Circulation : Clinical Summaries

<i>Circulation</i> : Clinical Summaries

Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation

Background— Very few data exist on the clinical impact of permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation. The objective of this study was to assess the impact of PPI after transcatheter aortic valve implantation on late outcomes in a large cohort of patients. Methods and Results— A total of 1556 consecutive patients without prior PPI undergoing transcatheter aortic valve implantation were included. Of them, 239 patients (15.4%) required a PPI within the first 30 days after transcatheter aortic valve implantation. At a mean follow-up of 22±17 months, no association was observed between the need for 30-day PPI and all-cause mortality (hazard ratio, 0.98; 95% confidence interval, 0.74–1.30; P =0.871), cardiovascular mortality (hazard ratio, 0.81; 95% confidence interval, 0.56–1.17; P =0.270), and all-cause mortality or rehospitalization for heart failure (hazard ratio, 1.00; 95% confidence interval, 0.77–1.30; P =0.980). A lower rate of unexpected (sudden or unknown) death was observed in patients with PPI (hazard ratio, 0.31; 95% confidence interval, 0.11–0.85; P =0.023). Patients with new PPI showed a poorer evolution of left ventricular ejection fraction over time ( P =0.017), and new PPI was an independent predictor of left ventricular ejection fraction decrease at the 6- to 12-month follow-up (estimated coefficient, −2.26; 95% confidence interval, −4.07 to −0.44; P =0.013; R 2 =0.121). Conclusions— The need for PPI was a frequent complication of transcatheter aortic valve implantation, but it was not associated with any increase in overall or cardiovascular death or rehospitalization for heart failure after a mean follow-up of ≈2 years. Indeed, 30-day PPI was a protective factor for the occurrence of unexpected (sudden or unknown) death. However, new PPI did have a negative effect on left ventricular function over time.