Predictors Of Permanent Pacemaker Implantation Research Articles

Anatomical Annulus Predictors of New Permanent Pacemaker Implantation Risk After Balloon-Expandable Transcatheter Aortic Valve Implantation

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.

Value of basal HV Interval prior TAVR as predictor of permanent pacemaker implantation

Abstract Background/Introduction Transfemoral aortic valve replacement (TAVR) is an effective and safe treatment for severe aortic stenosis (SAoS) even in low risk patients (1,2). As population ages, the volume of TAVR procedure increases and although improvements in technology and technique, new onset persistent disturbances in the electrocardiogram (ECG) are present up to 34,8% of patients at hospital discharge(3) and the secondary need of permanent pacemaker implantation (PPM) remains high, being of 4-24% with balloon-expanding valves (BEV) and 14.7-26.7% with self-expanding valves (SEV)(3). According to ESC guidelines, an electrophyisiologic study (EPS) centered in HV interval measure with a cutoff of ≥70ms is a useful tool to assess the risk of progression to high auriculoventricular block (HAVB) in specific groups with persistent ECG abnormalities to consider PPM(4-5), but this only applies in post TAVR scenario. Measuring HV interval at the intervention day prior procedure could help optimize and assess risk for PPM post TAVR. Purpose To measure basal HV interval prior TAVR and correlate it to risk of PPM implantation before discharge and 30 days after discharge. Methods Single-center prospective cohort study, patients with SAoS scheduled for TAVR, sinus rhythm at intervention day, without PPM or history of PPM indication were included. At time of TAVR, a tetrapolar catheter was placed at the septal aspect of tricuspid valve. A mobile polygraph was used to measure ECG parameters and HV interval before TAVR. Then, tetrapolar catheter was advanced to ventricle to perform rapid stimulation as part of habitual valve implantation protocol. After procedure, a rhythm monitorization for &amp;gt;48-72 hrs, was made to decide, PPM, HV interval measure or clinical daily ECG vigilance with posterior discharge was performed. A 30-day post discharge follow up was expected. Results 38 patients were enrolled, median age 83.5 ± 5.5 years, 23 females (60,5%). 37 patients had SEV implanted and 1 patient had BEV implanted. Median HV interval was 54.4ms. 18 patients (47.4%) had a mild abnormal HV interval, of whom 11 had a narrow QRS. Post TAVR procedure, 15 patients (39.5%) persisted with "de novo" LBB at discharge. 5 women and 7 men, had PPM implanted before discharge. 1 woman was implanted 6 days after discharge due to HAVB (66ms HV interval prior TAVR). In a multivariate analysis including sex, age, PR, QRS and HV interval &amp;gt;55ms, the RR (IC 95% 1.9-70.3) risk of PPM was 13.42 folds higher (p=0.008). At a bivariate quantitative HV analysis, a higher HV period persisted significantly related to PPM outcome (p=0.001). Conclusions In our study population, a pre-existing mild to moderate prolongation of HV interval prior TAVR substantially elevates the risk of requiring PPM before discharge. 61.1% of these basal mild prolongation HV interval patients had a narrow QRS prior TAVR.HV measure prior TAVR in narrow QRSTable 1

Impact of New-Onset Right Bundle-Branch Block After Transcatheter Aortic Valve Replacement on Permanent Pacemaker Implantation.

A delayed and recurrent complete atrioventricular block (CAVB) is a life-threatening complication of transcatheter aortic valve replacement (TAVR). Post-TAVR evaluation may be important in predicting delayed and recurrent CAVB requiring permanent pacemaker implantation (PPI). The impact of new-onset right bundle-branch block (RBBB) after TAVR on PPI remains unknown. In total, 407 patients with aortic stenosis who underwent TAVR were included in this analysis. Intraprocedural CAVB was defined as CAVB that occurred during TAVR. A 12-lead ECG was evaluated at baseline, immediately after TAVR, on postoperative days 1 and 5, and according to the need to identify new-onset bundle-branch block (BBB) and CAVB after TAVR. Forty patients (9.8%) required PPI, 17 patients (4.2%) had persistent intraprocedural CAVB, and 23 (5.7%) had delayed or recurrent CAVB after TAVR. The rates of no new-onset BBB, new-onset left BBB, and new-onset RBBB were 65.1%, 26.8%, and 4.7%, respectively. Compared with patients without new-onset BBB and those with new-onset left BBB, the rate of PPI was higher in patients with new-onset RBBB (3.4% versus 5.6% versus 44.4%, P<0.0001). On post-TAVR evaluation in patients without persistent intraprocedural CAVB, the multivariate logistic regression analysis showed that new-onset RBBB was a statistically significant predictor of PPI compared with no new-onset BBB (odds ratio [OR], 18.0 [95% CI, 5.94-54.4]) in addition to the use of a self-expanding valve (OR, 2.97 [95% CI, 1.09-8.10]). Patients with new-onset RBBB after TAVR are at high risk for PPI.

Intraoperative Corticosteroids and Pacemaker Implantation After Transcatheter Aortic Valve Replacement.

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of aortic stenosis. However, conduction disturbances leading to pacemaker implantation remain a common complication, increasing morbidity and mortality in these patients. Hence, measures to lower its incidence should be taken, and corticosteroid therapy could be effective by reducing inflammation caused by direct mechanical trauma to the conduction system. A retrospective cohort study was conducted at the Centro Hospitalar de Vila Nova de Gaia/Espinho, analyzing the medical records of patients with native severe aortic stenosis who underwent transfemoral TAVR in 2022. The Chi-square test was used to compare the rate of pacemaker implantation in patients who received corticosteroids with patients who didn't. The statistical significance was considered for a p-value <0.05. A total of 341 patients were included in this study. Monitored anesthesia care was the preferred anesthetic technique (99.1%). Sixty-three point three percent (63.3%) of patients received corticosteroids at the beginning of the procedure. Corticosteroid administration did not significantly affect the incidence of permanent pacemaker implantation (p=0.277), vascular complications on the access site (p=0.765), or in-hospital mortality (p=0.909). Male gender, 1st-degree atrioventricular block, and right branch block were the only identified predictors of permanent pacemaker implantation after transfemoral TAVR (p=0.041 <0.001 and <0.001, respectively). Corticosteroid administration at the beginning of TAVR doesn't seem to influence the incidence of permanent pacemaker implantation, which can suggest that other factors play a more important role in the development of conduction disturbances leading to pacemaker implantation.

Predictors and Trends of New Permanent Pacemaker Implantation: A Subanalysis of the International Navitor IDE Study

BackgroundThe Navitor Investigational Device Exemption (IDE) study is a prospective, multicenter, global study assessing the safety and effectiveness of the Navitor valve in a population with severe, symptomatic aortic stenosis who are at high and extreme surgical risk. The impact of pre-existing conduction abnormalities and implantation technique on new permanent pacemaker implantation (PPI) for the Navitor platform is not fully understood. Therefore, the goal of this analysis was to investigate the associations between patient and procedural factors and the 30-day new PPI rate. MethodsA total of 260 patients who underwent implantation of a Navitor valve in the Navitor IDE study were reviewed. Patients with preprocedural permanent pacemakers (n = 28) were excluded. Baseline risk factors were assessed for statistical significance. Multivariable logistic regression analyses were performed to identify independent predictors of new PPI. ResultsMean age of the pacemaker-naïve population was 83.3 ± 5.2 years, 58.6% were female, average Society of Thoracic Surgeons score was 3.8% ± 1.9%, median frailty score was 1 (interquartile range 1, 2), and 17.7% were deemed at extreme surgical risk. Pre-existing first-degree atrioventricular block and right bundle branch block significantly increased the risk of new PPI postimplantation, whereas left bundle branch block did not. Membranous septum length in relation to noncoronary cusp implant depth was a significant predictor of new PPI, with higher rates of new PPI observed when noncoronary cusp implant depth exceeded membranous septum length. Analysis of implant depth alone revealed deeper implants were associated with a higher rate of new PPI, regardless of patient baseline conduction abnormality. ConclusionsThe 30-day rate of new PPI in the Navitor IDE study is associated with patient pre-existing baseline conduction disturbances and implantation depth.

Risk Assessment of Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation in Patients With Preexisting Right Bundle Branch Block

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 <2mm (OR 2.02, 95% CI 1.09 to 3.75) in the univariate analysis and MS length <2mm (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.

Ratio of left ventricular outflow tract area to aortic annulus area and complete atrioventricular block after transcatheter aortic valve replacement for aortic stenosis

BackgroundMechanical compression of cardiac conduction system by transcatheter heart valves leads to complete atrioventricular block (CAVB) after transcatheter aortic valve replacement (TAVR). Bulging of ventricular septum in the left ventricular outflow tract (LVOT) may be associated with greater compression of conduction system, leading to irreversible CAVB. ObjectiveThis study aimed to investigate the association of ventricular septal bulging with TAVR-related CAVB and permanent pacemaker implantation (PPI). MethodsAmong 294 consecutive patients with severe aortic stenosis who underwent TAVR between July 2017 and February 2023, 271 were included in the analysis. As a quantitative evaluation of bulging of the ventricular septum, the ratio of LVOT area to aortic annulus area (L/A ratio) was measured at the systolic phase of computed tomography images. ResultsTAVR-related CAVB occurred in 64 patients (23.6%). Twenty-eight patients (10.3%) required PPI. The optimal thresholds of L/A ratio for predicting TAVR-related CAVB and PPI were 1.0181 and 0.985, respectively. Patients with less than the cut-off values had higher rate of TAVR-related CAVB and PPI than those above (28.3% vs 13.1%, p = 0.0063; 14.7% vs 4.4%, p = 0.0077, respectively). A multivariate analysis showed that L/A ratio < 1.0181 was an independent predictor of TAVR-related CAVB (odds ratio [OR] 2.65, p = 0.011), in addition to prior right bundle branch block (OR 3.76, p = 0.0005), use of a self-expanding valve (OR 1.99, p = 0.030), and short membranous septum length (OR 0.96, p = 0.037). Only L/A ratio < 0.985 was independently associated with PPI (OR 3.70, p = 0.011). ConclusionLow L/A ratio is a predictor of TAVR-related CAVB and PPI.

Novel predictors of permanent pacemaker implantation following transcatheter aortic valve replacement.

Conduction and rhythm abnormalities requiring permanent pacemakers (PPM) are short-term complications following transcatheter aortic valve replacement (TAVR), and their clinical outcomes remain conflicting. Potential novel predictors of post-TAVR PPM, like QRS duration, QTc prolongation, and supraventricular arrhythmias, have been poorly studied. To evaluate the effects of baseline nonspecific interventricular conduction delay and supraventricular arrhythmia on post-TAVR PPM requirement and determine the impact of PPM implantation on clinical outcomes. A retrospective cohort study that identified patients with TAVR between January 1, 2012 to December 31, 2019. The group was dichotomized into those with post-TAVR PPM and those without PPM. Both groups were followed for one year. Out of the 357 patients that met inclusion criteria, the mean age was 80 years, 188 (52.7%) were male, and 57 (16%) had a PPM implantation. Baseline demographics, valve type, and cardiovascular risk factors were similar except for type II diabetes mellitus (DM), which was more prevalent in the PPM cohort (59.6% vs 40.7%; P = 0.009). The PPM cohort had a significantly higher rate of pre-procedure right bundle branch block, prolonged QRS > 120 ms, prolonged QTc > 470 ms, and supraventricular arrhythmias. There was a consistently significant increase in the odds ratio (OR) of PPM implantation for every 20 ms increase in the QRS duration above 100 ms: QRS 101-120 [OR: 2.44; confidence intervals (CI): 1.14-5.25; P = 0.022], QRS 121-140 (OR: 3.25; CI: 1.32-7.98; P = 0.010), QRS 141-160 (OR: 6.98; CI: 3.10-15.61; P < 0.001). After model adjustment for baseline risk factors, the OR remained significant for type II DM (aOR: 2.16; CI: 1.18-3.94; P = 0.012), QRS > 120 (aOR: 2.18; CI: 1.02-4.66; P = 0.045) and marginally significant for supraventricular arrhythmias (aOR: 1.82; CI: 0.97-3.42; P = 0.062). The PPM cohort had a higher adjusted OR of heart failure (HF) hospitalization (aOR: 2.2; CI: 1.1-4.3; P = 0.022) and nonfatal myocardial infarction (MI) (aOR: 3.9; CI: 1.1-14; P = 0.031) without any difference in mortality (aOR: 1.1; CI: 0.5-2.7; P = 0.796) at one year. Pre-TAVR type II DM and QRS duration > 120, regardless of the presence of bundle branch blocks, are predictors of post-TAVR PPM. At 1-year post-TAVR, patients with PPM have higher odds of HF hospitalization and MI.

Prevalence and predictors of pacemaker implantation in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation: TAVI-NOR study

Abstract Background The transcatheter aortic valve implantation (TAVI) in patients with aortic stenosis (AS) asserts mechanical forces during valve expansion both on the aortic root and conduction system. TAVI is therefore frequently associated with the development of conduction abnormalities requiring a permanent pacemaker implantation (PMI). Purpose To identify predictors of new PMI in unselected patients with severe AS undergoing TAVI. Methods Among the 600 patients consecutively enrolled in TAVI-NOR study, 52 had PMI prior to TAVI and were excluded, remaining 548 patients eligible for this analysis. Predictors of PMI were identified in binary logistic regression analyses. Results A total of 189 patients (31.5%) required a new PMI post TAVI, evenly distributed between females and males (30.1% vs 32.9%, p=0.456). Higher age, comorbidities such as hypertension, chronic kidney disease, coronary artery disease, diabetes, and left ventricular hypertrophy on ECG or echocardiography, and the severity of AS had no association with the risk of PMI after TAVI (Table 1). In univariate logistic regression analyses, larger aortic root diameter was associated with a higher risk of new PMI (OR 1.66; 95% 1.07-2.58, p=0.024), but was no longer significant in multivariate model, and bioprosthesis size had no association with the need for a PMI following TAVI. Bundle branch block (BBB) (OR 1.52; 95% 1.00-2.31, p= 0.051), and especially right BBB (RBBB) (OR 2.05; 95% 1.14-3.70, p= 0.017) showed increased risk of a new PMI, also in a multivariable-adjusted analysis (OR 2.67; 95% 1.39-5.11, p=0.003). Lotus bioprosthesis with mechanical expansion was associated with an increased risk of PMI (OR 2.92; 95% CI 1.92-4.45, p&amp;lt;0.001), while balloon expandable Sapiens had a lower risk for PMI (OR 0.15; 95% CI 0.06-0.37, p&amp;lt;0.001). In a multivariable-adjusted analysis, the use of Lotus valve (OR 2.23; 95% CI 1.44-3.46, p&amp;lt;0.001) was still associated with a higher risk, and use of Sapien with a lower risk of PMI (OR 0.15; 95% CI 0.06-0.40, p&amp;lt;0.001) independent of non-significant association with atrial fibrillation (p=0.067), lower heart rate (0.077), aortic root (p=0.225) and stroke volume index (p=0.097). Adding age and gender to the same primary multivariable-adjusted model did not change our conclusions: Lotus (OR 2.28; 95% CI 1.46-3.57, p&amp;lt;0.001) and RBBB (OR 2.63; 95% CI 1.37-5.04, p=0.004) and Edward Sapien (OR 0.15; 95% 0.06-0.39, p&amp;lt;0.001) of post-procedural PMI. Conclusion Our data from less selected patients with severe AS patients show that pre-intervention RBBB and the use of bioprosthesis with mechanic expansion (Lotus) were associated with a higher risk, and the use of balloon expandable bioprothesis (Sapiens) with a lower risk of PMI after TAVI. We found no gender differences in risk of PMI.

Permanent pacemaker implantations among patients with spinal cord injury in the United States

Abstract Background Acute spinal cord injury (SCI) is associated with severe cardiovascular complications. Information regarding the need for permanent cardiac pacing in SCI patients is scarce and based on case reports and small case series. We aimed to investigate the extent of permanent pacemaker (PPM) implantation procedures as well as to identify predictors for PPM insertion among SCI patients in a U.S contemporary, nationwide, all-comer registry. Methods Using the National Inpatient Sample (NIS) database, patients hospitalized with a primary diagnosis of SCI in the US between 2016-2019 and underwent PPM implantation were identified. Patients with cardiac implantable electronic device in-situ were excluded. Baseline demographics, clinical characteristics, injury type, in-hospital procedures and outcomes including time to PPM implantation, length of stay and mortality were collected. Outcome analysis performed after propensity score matching (PSM). Predictors of PPM implantation were identified via a multivariable logistic regression model. Results A total of 35880 patients, were hospitalized with a primary diagnosis of SCI during the study period, and 240 (0.7%) received a PPM. Median age of patients receiving PPM was 69 years, 75% were males, and 67% had high level SCI injury (level C1-5). Time to PPM implantation was 9 days (IQR 4-19). PPM implantation was associated with higher rates of cervical spine injuries, traumatic brain injury (TBI), chest and upper limbs injuries, respiratory failure and other signs of severe illness. Longer hospital stay and higher in-hospital mortality rate was observed in patients receiving a PPM. Multivariate analysis identified the following independent risk factors for PPM implantation: cervical SCI [OR 77.07 (11.13-553.42), p&amp;lt;0.001], TBI [OR 3.84(1.59-9.28), p=0.003] and tracheostomy/respiratory ventilation&amp;gt; 96 h [OR 31.766(7.91-127.54), p=&amp;lt;0.001]. Conclusion Cervical SCI, need for tracheostomy and prolonged mechanical ventilation were the strongest predictors for PPM implantation in patients hospitalized for SCI in a nationwide registry.

Left ventricular outflow tract eccentricity and the aortic annulus perimeter are strong predictors of permanent pacemaker implantation after self-expandable TAVR insertion

Abstract Introduction Transcatheter aortic valve replacement (TAVR) has become the treatment of choice for many patients with degenerative aortic stenosis. Nevertheless, need for permanent pacemaker implantation (PPI) continues being the Achilles heel after TAVR, especially for self-expanding valves. On the other hand, computed tomography (CT) scan provides several measurements with paramount importance for the success of the procedure. The aim of our study was to investigate whether CT-scan could help to identify patients at high risk for PPI need after TAVR. Methods We included all consecutive patients who underwent successful TAVR in a single center, since 2018 to 2022. Patients with previous PPI, "valve in valve" procedures, or without CT-scan measures of interest were excluded. Patients were followed-up at least 30 days after index procedure. Clinical, electrocardiographic and procedural characteristics were recorded, as well as CT-scan variables, such as annulus and left ventricle outflow tract (LVOT) perimeter and major and minor axis of both. Eccentricity index (EI) was calculated using the formula for the ellipse (the square root of 1-(minor axis/major axis)2), where the closer to 0 means more circular and the closer to 1 more eccentric ellipse. Multivariate binary logistic regression, including known clinical and electrocardiographic predictors of PPI after TAVR, along with CT-scan measurements, was done searching for the model best predicting PPI-need 30 days after TAVR. Results From the 297 patients undergoing TAVR in our centre during the study period, 106 were excluded because they met one of the excluding criteria (64 because of the lack of complete CT-scan data). Thus, 191 patients form the study population. 40 patients (20.9%) required a PPI. Characteristics of patients with/out PPI are shown at Table 1. After multivariate regression analysis, the best model predicting PPI included pre-existing complete right bundle branch block (RBBB) (HR: 3.86; 95%CI [1.35-11.02], p=0.013), larger valve size (HR (29-34 mm vs. 23-26 mm): 3.00; 95%CI [1.34-6.75], p=0.006) and LVOT EI (HR for every increase in 0.01: 0.96; 95%CI [0.94-0.99], p=0.021). C-statistic of the model was estimated in 0.762 (95%CI [0.677-0.847], p&amp;lt;0.001). ROC curve obtained with the model is shown at Figure 1. Conclusions Previous CT-scan measurements may help to identify patients at high risk for PPI after self-expanding TAVR. In our series, the strongest predictors for PPI were RBBB, LVOT EI (the lower the eccentricity, the higher the risk) and use of larger prostheses size (29 and 34 mm), which may be considered as a surrogate of the annular perimeter obtained by CT-scan.Baseline characteristicsROC curve

Predictors of permanent pacemaker implantation after transcatheter aortic valve implantation - Results from the SOLVE-TAVI trial

Abstract Background Permanent pacemaker implantation (PPI) is frequently required following transcatheter aortic valve implantation (TAVI). However, the predisposing parameters increasing the likelihood of severe conduction abnormalities are still not fully understood. Purpose To analyze predictors of PPI 30 days after TAVI. Methods The SOLVE-TAVI trial randomized 447 patients to TAVI using either the balloon-expandable Edwards Sapien 3 valve or the self-expanding Medtronic Evolut R valve. Pacemaker rates at 30 days were relatively high, but comparable between both transcatheter heart valve (THV) types (19% vs. 23%). Computed tomography (CT) scans were analyzed semi-automatically to determine aortic annulus size and subannular calcification. The percentage of THV oversizing was calculated using the formula (nominal THV circumference/annular circumference – 1) x 100). Results From all patients treated with either the Sapien 3 or Evolut R valve, 47 patients were excluded because of prior pacemaker implantation. Rates of new PPI at 30 days were similar in patients with and without pre-existing left bundle branch block (7/36 patients vs. 53/342 patients, p=0.48) and right bundle branch block (11/51 patients vs. 48/327 patients, p=0.22), without significant differences according to valve type. Patients with new PPI showed a significantly higher degree of THV oversizing compared to patients without PPI (median 15%, interquartile range [IQR] 9-20% vs. median 12%, IQR 7-17%; p=0.03). Moderate/severe compared to no/mild subannular calcification did not result in higher PPI rates (17/121 patients vs. 40/245 patients; p=65). Conclusion THV oversizing but not pre-existing left and right bundle branch block and subannular calcification is associated with PPI after TAVI.

Implantation depth of balloon-expandable transcatheter heart valves and risks for permanent pacemaker implantation and midterm adverse events.

Permanent pacemaker implantation (PPI) remains a relevant complication after transcatheter aortic valve implantation (TAVI) and its impact on outcome remains controversial. This study aimed to analyze the effects of implantation depth on PPI at 30 days and assess its impact on outcome with the balloon-expandable Sapien 3 (S3) prosthesis. Between 2014 and 2018, 849 patients without previous pacemaker undergoing transfemoral TAVI with the S3 were included. Prosthesis implantation depth was measured and divided into Quintiles. An ordinal logistic regression was used to assess its association with PPI, while a multivariate logistic regression was performed to identify predictors of PPI. Survival analyses were performed with the Kaplan-Meier method and a multivariable Cox regression was performed to ascertain the impact of PPI on mortality. Overall, incidence of PPI at 30 days was 9.7%. Implantation depth decreased consistently from a median of 6.7 mm [5.55-8.00] in 2014 to 2.7 mm [2.30-3.50] in 2018 (p < 0.001). When considering Quintiles of implantation depth, incidence of PPI was significantly higher in upper Quintiles and risk for PPI was significantly lower for the 1. Quintile compared to the 5. Quintile (OR: 0.34, 95% CI: [0.16-0.73]; p = 0.003). In the adjusted multivariable logistic regression implantation depth persisted ad independent predictor of PPI at 30 days. Patients requiring PPI at 30 days displayed significantly higher mortality at 4 years compared to patients without PPI (49.5% vs. 40.0%; log-rank = 0.022). In a multivariate analysis, increased logistic EuroScore, diabetes mellitus, and history of atrial fibrillation, were independent predictors of all-cause mortality at 2 years. Higher prosthesis implantation relative to the virtual aortic annulus was significantly associated with reduced risk for PPI at 30 days. Patients with PPI at 30 days exhibited higher mortality during follow-up, however, only logistic EuroScore, diabetes mellitus, and history of atrial fibrillation were identified as independent predictors of mortality at 2 years.

Predictors of permanent pacemaker implantation in aortic valve diseases after TAVI with vitaFlow liberty system.

Permanent pacemaker implantation (PPI) is a known complication in patients with aortic stenosis following transcatheter aortic valve implantation (TAVI). However, there is limited research on TAVI for pure aortic regurgitation (PAR), and more investigation is needed to determine the occurrence of postoperative cardiac conduction block and the need for PPI in this population. Therefore, this retrospective analysis aimed to evaluate the incidence of cardiac conduction block and the necessity of PPI after TAVI in patients with different types of aortic valve disease, including pure aortic stenosis (PAS), aortic stenosis with regurgitation (ASR), and PAR. Clinical data of 100 patients who TAVI were analyzed retrospectively. The incidence of conduction block was assessed, and clinical factors were examined to predict the necessity of PPI. Cardiac conduction block was found to be a common complication following TAVI, particularly in patients with PAR. PAR was identified as an independent risk factor for requiring PPI. Additionally, first-degree atrioventricular block emerged as a sensitive predictor for PPI in patients with PAR. These findings provide valuable insights into the safety and effectiveness of TAVI, which can help enhance patient management and reduce complications.

Incidence, Predictors, and Prognostic Impact of New Permanent Pacemaker Implantation After TAVR With Self-Expanding Valves

ObjectivesThe authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). BackgroundNeed for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. MethodsThis study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. ResultsNew PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). ConclusionsNew PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI.

Permanent Pacemaker Use in Transcatheter Aortic Valve Replacement: Real World Experience from the National Inpatient Sample

Background: Transcatheter Aortic Valve Replacement (TAVR) is associated with conduction abnormalities requiring permanent pacemaker implantation (PPMI). Data regarding predictors for PPMI following TAVR is scarce. Methods: This is a retrospective study utilizing the 2017 National In-Patient Sample (NIS). Patients who underwent TAVR and PPMI during the same admission were identified using appropriate ICD-10 codes, as were patients with left bundle branch (LBBB), right bundle branch (RBBB), and first-degree AV delay (AVB). Patients were split into two groups based on PPMI. The groups were compared using univariate and multivariate analyses after adjusting for age, gender, race, comorbidities, insurance status, and Charlson comorbidity index (CCI). Secondary outcomes included factors influencing length of stay (LOS) and total charges incurred. Results: In 2017, 54,175 (57.6% males) patients underwent TAVR. There were 8,067 patients with LBBB, 2,402 with RBBB, and 2,905 with AVB at baseline. A 4170 total of patients (55.2% males) required PPMI. Patients requiring PPMI were older (80.5 vs 79.6 years, p=0.001). On multivariate analyses, baseline RBBB, LBBB, hypertension (HTN), CCI 2, and CCI &gt;/=3 predicted PPMI (aOR 4.82, p&lt;0.001; aOR 1.63, p&lt;0.001; aOR 1.21, p=0.013, aOR 1.53, p=0.022 and aOR 1.46, p=0.031 respectively). On multivariate analyses, patients who underwent PPMI had significantly higher LOS (aOR 2.18, p&lt;0.001) and incurred higher total charges (USD 278,000 vs USD 204,920; p&lt;0.001). Conclusion: In this cohort, RBBB, LBBB, HTN, and increased CCI predicted PPMI after TAVR. Further studies are required to corroborate our findings.

Cusp overlap versus standard three-cusp technique for self-expanding Evolut transcatheter aortic valves.

Reducing rates of permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) is important for achieving the best procedural outcomes. The cusp overlap technique (COT) implements procedural steps including an overlap angulation of the right and left coronary cusp to mitigate this complication. We investigated the incidence of PPI and complication rates following the COT compared to the standard three-cusp implantation technique (3CT) in an all-comers cohort. Atotal of 2,209 patients underwent TAVI with the self-expanding Evolut platform from January 2016 to April 2022 at five sites. Baseline, procedural and in-hospital outcome characteristics were compared for both techniques before and after one-to-one propensity score matching. Atotal of 1,151 patients were implanted using the 3CT and 1,058 using the COT. At discharge, the rates of PPI (17.0 vs 12.3%; p=0.002) and moderate/severe paravalvular regurgitation (4.6% vs 2.4%; p=0.006) were significantly reduced with the COT compared with 3CT within the unmatched cohort. Overall procedural success and complication rates were similar; major bleeding was less common in the COT group (7.0% vs 4.6%; p=0.020). These results remained consistent after propensity score matching. In multivariable logistic regression analysis, right bundle branch block (odds ratio [OR] 7.19, 95% confidence interval [CI]: 5.18-10.0; p<0.001) and diabetes mellitus (OR 1.38, 95% CI: 1.05-1.80; p=0.021) emerged as predictors of PPI, whereas the COT (OR 0.63, 95% CI: 0.49-0.82; p<0.001) was protective. The introduction of the COT was associated with asignificant and relevant reduction of PPI and paravalvular regurgitation rates without an increase in complication rates.

The prevalence of permanent pacemaker implantation after open-heart surgeries; eight years of experience in Tehran heart center

BackgroundWe aimed to evaluate the prevalence of permanent pacemaker implantation (PPI) among open-heart surgery patients.MethodsWe reviewed data from 23 461 patients undergoing open-heart surgeries between 2009 and 2016 in our heart center in Iran. A total of 18 070 patients (77%) had coronary artery bypass grafting (CABG), 3 598 (15.3%) valvular surgeries, and 1 793 (7.6%) congenital repair procedures. Finally, 125 patients who received PPI following open-heart surgeries were enrolled in our study. We defined the demographic and clinical characteristics of all these patients.ResultsPPI was required in 125 (0.53%) patients with an average age of 58 ± 15.3 years. The average hospitalization time after surgery and waiting time for PPI were 19.7 ± 10.2 and 11.4 ± 6.5 days, respectively. Atrial fibrillation was the dominant pre-operative cardiac conduction abnormality (29.6%). Also, the primary indication for PPI was complete heart block in 72 patients (57.6%). Patients in the CABG group were significantly older (P = 0.002) and were more likely to be male (P = 0.030). The valvular group longer bypass and cross-clamp times and had more left atrial abnormalities. In addition, the congenital defect group was younger and had longer ICU stay times.ConclusionsBased on our study findings, PPI was required in 0.53% of patients following open-heart surgery due to damage to the cardiac conduction system. The current study paves the way for future investigations to identify possible predictors of PPI in patients undergoing open-heart surgeries.

Site-Level Variation and Predictors of Permanent Pacemaker Implantation Following TAVR in the Evolut Low-Risk Trial

We evaluated predictors of permanent pacemaker implantation (PPI) following self-expanding transcatheter aortic valve replacement (TAVR), examined site-to-site variability of PPI rates, and explored the relationship of implantation methods on the need for PPI. Despite the benefits of TAVR compared to surgical aortic valve replacement, increased PPI remains a limitation. A total of 699 patients without baseline PPI were included in the study. Clinical, echocardiographic, and procedural characteristics were compared in patient with and without new PPI. Clinical outcomes were assessed at 30 days and 1 year. Funnel plots were constructed to display site-to- site variability and identify outliers in PPI. Clinical outcomes were similar in patients with and without PPI. Predictors of a new PPI within 7 days included a baseline right bundle branch block (p < 0.001) and not using general anesthesia (p = 0.003). There was substantial site to site variability in the rate of PPI. Patients at sites with a lower PPI rate had shallower implantation depth at the non-coronary (p < 0.001) and the left coronary sinus (p < 0.001), and fewer patients with an implantation depth > 5 mm below the annulus (p = 0.004). In low-risk patients undergoing TAVR with Evolut valves, baseline conduction disorders and implant depth were important predictors of PPI. Implantation method may have contributed to this variability in PPI rates across clinical sites.

Long-term follow-up of patients with drug-related atrioventricular block without a need of permanent pacemaker during index hospitalization

BackgroundMost of the patients hospitalized due to drug-related atrioventricular (AV) block do not require permanent pacemaker implantation (PPI) since AV block regresses following cessation of the responsible drug. However, AV block requiring PPI may relapse in long-term follow-up. In this study, we retrospectively evaluated the factors predicting the need for a PPI in the long-term follow-up in patients admitted to our hospital with drug-related AV block but did not require PPI in index hospitalization.ResultsWe evaluated 177 patients who had been hospitalized with drug-related AV block between January 2012 and July 2020 and who had not required PPI during hospital follow-up. The patients were divided into two groups according to whether PPI was performed or not. The independent predictors of long-term PPI were evaluated and the effect of glomerular filtration rate (GFR) of the patients during the index hospitalization on the long-term outcome was compared. A GFR above 60 ml/min is an independent significant risk factor in predicting long-term permanent pacemaker implantation in drug-related AV blocks. It is found that the need for PPI was 2.64 times higher without adjusted and 1.9 times higher with adjusted for all covariates in patients with GFR above 60 ml/min during hospitalization compared to those with GFR below 30 ml/min.ConclusionsGFR may be considered as an indicator of the PPI need in patients with drug-related atrioventricular AV block.