Impact Of Permanent Pacemaker Implantation Research Articles

Permanent pacemaker implantation is associated with an increased risk of heart failure hospitalization in transcatheter aortic valve implantation patients with reduced systolic function

Abstract Background The impact of permanent pacemaker implantation (PPI) on outcome of patients following transcatheter aortic valve implantation (TAVI) is not fully understood. Purpose This study aimed to assess the impact of PPI on risk of two-year mortality and hospitalization due to heart failure (HF) in TAVI patients. Methods A total of 1275 consecutive patients who underwent TAVI at our hospital between 2009 and 2021 were enrolled in this study (mean age 81.4±5.6 years, 51.8% male). The primary endpoint was defined as two-year all-cause death after TAVI. The second endpoints included cardiovascular (CV) death and HF related hospitalization after TAVI. Results Among the 1275 patients following TAVI, 297 (23.3%) patients received PPI, with 134 receiving PPI before TAVI and 163 receiving PPI after TAVI. The patients were categorized into two groups: no PPI group (n=978) and PPI group (n=297). Compared to patients without PPI, patients who received PPI were more likely to be male (60.9% vs. 49.1%, P<0.001), higher prevalence of atrial fibrillation (51.2% vs. 43.3%, P=0.016), coronary artery disease (61.6% vs. 53.8%, P=0.017), use aldosterone receptor antagonists (MRAs, 25.3% vs. 15.2%, P<0.001), and lower left ventricular ejection fraction (LVEF, 54.9±13.1% vs. 57.5±11.4%, P<0.001). There were no significant differences in all-cause mortality (16.6% vs. 18.5%), CV mortality (11.3% vs. 13.5%), as well as HF hospitalization rate (18.5% vs, 21.2%) between the two groups (P>0.05). In this cohort, 1012 (79.4%) TAVI patients had a preserved LVEF (≥50%), 122 (9.6%) had a mildly reduced LVEF (41-49%), and 141 (11.1%) had reduced LVEF (≤40%). Their primary and secondary outcomes were similar among LVEF subgroups (all P>0.05). In the subgroup of reduced LVEF, the HF related hospitalization rate after TAVI was significantly higher in TAVI patients with PPI compared to those without PPI (30.6% vs. 13.0%, P=0.003). Multivariable Cox regression models demonstrated a 3-fold increased risk of HF related hospitalization in TAVI patients with PPI in comparison to those without PPI in the subgroup of LVEF≤40% (HR 3.057, 95% CI 1.311-7.130, P=0.010) after adjusting for age, sex, TAVI approach, atrial fibrillation, coronary artery disease, and the use of MRAs. Conclusion All-cause mortality and CV mortality are similar between TAVI patients with and without PPI. However, in the subset of TAVI patients with reduced LVEF (≤40%), PPI is associated with an increased risk of HF hospitalization. Efforts are thus needed to reduce the risk of HF hospitalization in these patients.

The impact of permanent pacemaker implantation on long-term survival after cardiac surgery: A systematic review and meta-analysis

ObjectivesThe 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. MethodsMEDLINE, 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. ResultsA 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. ConclusionsPPM 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.

Increased cardiovascular mortality in patients with mechanically expandable transcatheter aortic valve and without permanent pacemaker

IntroductionUse of the mechanically expandable transcatheter aortic valve (MEV) has been recently linked to increased risks of valve dysfunction and cardiovascular mortality. The risk of developing conduction disturbance with the...

Clinical impact of permanent pacemaker implantation following surgical ablation of atrial fibrillation concomitant to mitral valve surgery: a multicenter study

Abstract Background Permanent pacemaker (PPM) implantation is a common adverse event following arrhythmia surgery. However, the epidemiology and clinical impact of PPM has been shown in only few studies in heterogeneous population, and the results are controversial. Purpose The present study aimed to investigate the clinical impact of PPM implantation following surgical ablation of atrial fibrillation (AF) concomitant to mitral valve (MV) surgery. Methods We identified 721 patients (aged 60.2±11.0 years, 437 females) who underwent surgical ablation of AF along with MV repair or replacement at five representative institutions in Korea between 2005 and 2017. Of these, 56 had PPM implanted (PPM group) and the remainder (n=665) did not receive a PPM (No-PPM group). The clinical outcomes were compared between the groups, and multivariable Cox proportional hazard analysis with time-varying covariate was conducted to determine the impact of PPM implantation on mortality and stroke. Results The patients in the PPM group were older, and had a higher CHAD2S2-VASc score than those in the No-PPM group (Table). During follow-up of 68.3 months (interquartile range 44.5-105.4 months), no significant survival difference was evident between the groups, however, the PPM group presented a significantly higher incidence of stroke than No-PPM group (p&amp;lt;0.001) (Figure). On time-varying multivariable analysis, the PPM was not a risk factor for mortality (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.18-1.08; p=0.072), however, old age (HR, 1.10; 95% CI, 1.07-1.13; p&amp;lt;0.001), chronic kidney disease (HR, 1.61; 95% CI, 1.01-2.58; p=0.046) and previous cardiac surgery (HR, 1.86; 95% CI, 1.01-3.21; p=0.027) were independent predictors of mortality in this subset of patients. The only significant risk factor for stroke was CHAD2S2-VASc score (HR, 1.27; 95% CI, 1.01-1.61; p=0.044), and PPM was not associated with risk of stroke (HR, 1.87; 95% CI, 0.71-4.90; p=0.202). Conclusion PPM implantation following surgical ablation of AF concomitant to MV surgery was not associated with an increased risk of mortality or stroke. This study result provides a supporting evidence for an active attempt in surgical ablation despite of inherent risk of PPM implantation.

Abstract 15691: Permanent Pacemaker Implantation After Aortic Valve Surgery for Infective Endocarditis Was Associated With an Increased Risk of Heart Failure

Background Surgery for infective endocarditis (IE) is associated with a high risk of receiving a new permanent pacemaker. The clinical impact of permanent pacemaker implantation in these patients is unknown. Research question Does permanent pacemaker implantation after aortic valve surgery for IE affect long-term clinical outcomes? Aims To analyze the risk of mortality, heart failure hospitalization, and prosthetic valve endocarditis in patients who received a permanent pacemaker within 30 days of aortic valve surgery for IE. Methods: In this nationwide, population-based, observational cohort study based on the SWEDEHEART register, we included all patients who underwent primary aortic valve replacement for IE in Sweden from 1997 to 2022. Patients with a preoperative cardiac implantable electronic device were excluded. The primary outcome was all-cause mortality. Secondary outcomes were heart failure hospitalization and prosthetic valve endocarditis. Follow-up was complete. Inverse probability of treatment weighting was used to account for intergroup differences and flexible parametric models were used to estimate cause-specific hazards and cumulative incidences. Results: Among 2110 patients, 131 patients (6%) received a new permanent pacemaker, and 1979 patients (94%) did not. The mean age was 59 years, and 433 patients (21%) were female. During a mean follow-up time of 8.5 years (maximum 26 years), 873 patients (41%) died. The cumulative incidence of all-cause mortality and heart failure hospitalization at 20 years was 66% (95% CI 46%-79%) versus 61% (95% CI 58%-64%) and 45% (95% CI 33%-58%) versus 32% (95% CI 29%-34%) in the pacemaker versus the non-pacemaker group, respectively. After adjustment, there was no difference in the risk of mortality (HR 1.14, 95% CI: 0.82-1.59) or reinfection (HR 1.00, 95% CI 0.63-1.59), but the risk of heart failure was increased in the pacemaker group (HR 1.67, 95% CI: 1.11-2.52). Conclusion Permanent pacemaker implantation after aortic valve surgery for IE was associated with an increased risk of heart failure, but there was no difference in the risk of long-term mortality or prosthetic valve endocarditis. These results suggest that patients who receive a pacemaker after surgery for IE warrant careful observation.

Prognostic impact of permanent pacemaker implantation after transcatheter aortic valve replacement

Prognostic impact of permanent pacemaker implantation after transcatheter aortic valve replacement

Prognostic impact of permanent pacemaker implantation after transcatheter aortic valve replacement.

Conduction disturbances requiring permanent pacemaker implantation (PPI) remain a common complication of transcatheter aortic valve replacement (TAVR). The purpose of this study was to determine the prognostic impact of PPI after TAVR according to the timing of implantation relative to TAVR. A total of 1199 patients (median age 83 years; interquartile range 78-86 years; 549 [45.8%] female) were included in the analysis, of whom 894 (70.8%) had not undergone PPI, 130 (10.8%) had undergone previous PPI, 116 (9.7%) had undergone in-hospital PPI, and 59 (4.9%) had undergone PPI during follow-up. Median follow-up was 2.94 years (1.42-4.32 years). The primary outcome was the composite of all-cause mortality and hospitalization for heart failure. PPI during follow-up was associated with a higher occurrence of the primary outcome (hazard ratio [HR] 2.11; 95% confidence interval [CI] 1.39-3.20) whereas previous PPI and in-hospital PPI were not (HR 0.96; 95% CI 0.71-1.29 and HR 1.26; 95% CI 0.88-1.81, respectively). PPI during follow-up was associated with a higher risk of hospitalization for heart failure (sub-HR 3.21; 95% CI 2.02-5.11), while this relationship was only borderline significant for previous PPI (sub-HR 1.51; 95% CI 0.99-2.29). In contrast, there was no relationship between in-hospital PPI and the subsequent risk of hospitalization for heart failure. Previous PPI and in-hospital PPI had no long-term prognostic impact on the risk of all-cause mortality and hospitalization for heart failure, whereas PPI during follow-up was associated with a higher risk of hospitalization for heart failure. The present study questions the deleterious influence of periprocedural post-TAVR PPI, which has previously been suggested by certain studies.

Long-term clinical impact of permanent pacemaker implantation in patients undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis.

AimsThe aims of this study is to assess by an updated meta-analysis the clinical outcomes related to permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) at long-term (≥12 months) follow-up (LTF).Methods and resultsA comprehensive literature research was performed on PubMed and EMBASE. The primary endpoint was all-cause death. Secondary endpoints were rehospitalization for heart failure, stroke, and myocardial infarction. A subgroup analysis was performed according to the Society of Thoracic Surgeon—Predicted Risk of Mortality (STS-PROM) score. This study is registered with PROSPERO (CRD42021243301). A total of 51 069 patients undergoing TAVI from 31 observational studies were included. The mean duration of follow-up was 22 months. At LTF, PPI post-TAVI was associated with a higher risk of all-cause death [risk ratio (RR) 1.18, 95% confidence interval (CI) 1.10–1.25; P < 0.001] and rehospitalization for heart failure (RR 1.32, 95% CI 1.13–1.52; P < 0.001). In contrast, the risks of stroke and myocardial infarction were not affected. Among the 20 studies that reported procedural risk, the association between PPI and all-cause death risk at LTF was statistically significant only in studies enrolling patients with high STS-PROM score (RR 1.25, 95% CI 1.12–1.40), although there was a similar tendency of the results in those at medium and low risk.ConclusionPatients necessitating PPI after TAVI have a higher long-term risk of all-cause death and rehospitalization for heart failure as compared to those who do not receive PPI.

628 Long-term clinical impact of permanent pacemaker implantation in patients undergoing transcatheter aortic valve intervention: a systematic review and meta-analysis

Abstract Aims As compared with surgery, transcatheter aortic valve implantation (TAVI) is associated with increased need for permanent pacemaker implantation (PPMI). The clinical impact of PPMI post-TAVI has not been fully established. To assess by an updated meta-analysis the clinical outcomes related to PPMI after TAVI at long-term (≥12 months) follow-up (LTF). Methods and results A comprehensive literature research was performed on PubMed and EMBASE. The primary endpoint was all-cause death. Secondary endpoints were rehospitalization for heart failure, stroke, and myocardial infarction. A subgroup analysis was performed according to Society of Thoracic Surgeon—Predicted Risk of Mortality (STS-PROM) score. A total of 31 studies were identified, providing data on 51 069 patients. The mean duration of follow-up was 22 months. At LTF, PPMI post-TAVI was associated with a higher risk of all-cause death [22.9% vs. 19.6%; risk ratio (RR), 1.18, 95% confidence interval (CI), 1.10–1.25; P &amp;lt; 0.001] and rehospitalization for heart failure (16.6% vs. 15.1%; RR, 1.32; 95% CI, 1.13–1.52; P &amp;lt; 0.001). In contrast, risks of stroke and myocardial infarction were not affected. Among the 20 studies that reported surgical risk, the association between PPMI and LTF all-cause death risk was statistically significant only in studies enrolling patients with high STS-PROM score (RR, 1.25; 95% CI, 1.12–1.40), although there was a similar trend in those at medium and low-risk. Conclusions Patients necessitating PPMI after TAVI have higher long-term risk of all-cause death and rehospitalization for heart failure as compared to those who do not receive PPMI. Thus, strategies aimed at reducing need for PPMI might improve survival after TAVI.

Outcomes Following Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: SWEDEHEART Observational Study.

This study was performed to investigate long-term, clinically important outcomes in patients who underwent permanent pacemaker implantation after transcatheter aortic valve replacement (TAVR). The impact of permanent pacemaker implantation after TAVR is unknown, and prior studies have produced conflicting results. In this nationwide, population-based cohort study, the study included all patients who underwent transfemoral TAVR in Sweden from 2008 to 2018 from the SWEDEHEART (Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies) register. Additional baseline characteristics and information about outcomes were obtained by individual crosslinking with other national health data registers. Unadjusted and multivariable-adjusted analyses were performed using Cox proportional hazards regression. Of 3,420 patients, 481 (14.1%) underwent permanent pacemaker implantation within 30days after TAVR. The survival rate at 1, 5, and 10 years was 90.0%, 52.7%, and 10.9% in the pacemaker group and 92.7%, 53.8%, and 15.3% in the nonpacemaker group, respectively (HR: 1.03; 95% CI: 0.88-1.22; P=0.692). The median follow-up was 2.7 years (interquartile range: 2.5, and maximum 11.8 years). There was no difference in the risk of cardiovascular death (HR: 0.91; 95%CI: 0.71-1.18; P = 0.611), heart failure (HR: 1.23; 95%CI: 0.92-1.63; P = 0.157), or endocarditis (HR: 0.90; 95%CI: 0.47-1.69; P = 0.734) between the groups. The study found no difference in long-term survival between patients who did and did not undergo permanent pacemaker implantation after TAVR. As the use of TAVR expands to include younger and low-risk patients with a long life expectancy, it will become increasingly important to understand the impact of permanent pacemaker implantation after TAVR.

THE LONG-TERM IMPACT OF PERMANENT CARDIAC PACING AFTER SURGICAL AORTIC VALVE REPLACEMENT: A SYSTEMATIC REVIEW AND META-ANALYSIS

<h3>BACKGROUND</h3> Permanent pacemaker (PPM) implantation after isolated surgical aortic valve is associated with short- and long-term complications. However, the impact of PPM implantation on long-term mortality has not been fully established. While some studies have demonstrated no effect, others have suggested that PPM reduces long-term survival. Therefore, our objective was to determine whether PPM post-SAVR increases the risk of mortality by performing a systematic review and meta-analysis. <h3>METHODS AND RESULTS</h3> We searched MEDLINE and EMBASE from inception to December 2020 for studies comparing mortality between post-SAVR patients who received PPM and those who did not. Studies were excluded, if they enrolled pediatric patients, if patients underwent other concomitant cardiac surgical procedure, and if transcatheter, sutureless, or rapid deployment valvular prosthesis were used. Random effects meta-analysis was performed using the restricted maximum likelihood estimator with Hartung-Knapp adjustment. The effect sizes were reported as relative risk (RR) with 95% confidence intervals. The analyses were performed using the metaprop and metafor packages for R version 3.01. The literature search yielded a total of 1,903 articles – of which 30 underwent full text review. Three articles met the inclusion and exclusion criteria, thus yielding a total of 9,105 patients. Two out of the three articles reported the hazard ratio adjusted for multiple covariates. The articles had at least 5 years of follow-up, and the pooled age was similar between the PPM (72 [95%CI 68-76] years) group and no PPM group (74 [95%CI 68-76] years). There was no difference between the groups in the number of men (PPM: 59% vs no PPM: 63%, p=0.90), patients with diabetes (PPM: 30% vs no PPM: 24%, p=0.31), hypertension (PPM: 72% vs no PPM: 68%, p=0.28), and atrial fibrillation (PPM: 21% vs no PPM: 13%, p=0.06). There was no difference in early mortality between the PPM and no PPM groups (RR 1.19; 95%CI 0.20-7.08; I2=23%). However, PPM implantation was associated with higher late mortality (RR 1.49; 95%CI 1.25-1.77; I2=0%) compared to the no PPM group. <h3>CONCLUSION</h3> While PPM post-SAVR does not increase early mortality, PPM independently increases the risk of mortality in the long-term. With the widespread adoption of innovative techniques like transcatheter and rapid deployment/sutureless valves that are known to be associated with high PPM rates, it becomes very important to observe for any excess long-term mortality that might be related to PPM implantation after these techniques.

Incidence and Outcomes of Pericardial Effusion and Cardiac Tamponade Following Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation

Permanent pacemaker (PPM) implantation is required in 5% to 10% of patients following transcatheter aortic valve implantation (TAVI). However, there are limited data on the impact of PPM implantation on the incidence of pericardial effusion, cardiac tamponade, and outcomes after TAVI. We identified all hospitalizations in patients ≥18 years of age who underwent TAVI in the years 2016 to 2017 in the Nationwide Readmission Database. The endpoints of the study were pericardial effusion, cardiac tamponade, and percutaneous or surgical drainage of the pericardial cavity in patients that required PPM implantation after TAVI. Multivariable logistic regression determined associations of PPM implantation, pericardial effusion, and tamponade with patient outcomes. A total of 54,317 unweighted hospitalizations for TAVI were identified, of which 5,639 (10.4%) required PPM. The risk of pericardial effusion was significantly greater in patients who required PPM (2.4% vs 1.6%, adjusted odds ratio (aOR) 1.39 (1.15 to 1.70), p <0.001)), and risk of cardiac tamponade nearly doubled (1.6% vs 0.8%, p <0.001; aOR: 1.90 (1.48 to 2.40), p <0.001). Female gender was independently associated with increased risk of pericardial effusion and cardiac tamponade whereas history of previous CABG was associated with decreased risk of both. Pericardial complications following PPM implantation were associated with increased in-hospital mortality, length of stay (LOS), hospital costs, and risk of 30-day readmission following TAVI (p <0.01 for all comparisons). In conclusion, although common, PPM implantation post-TAVI carries increased risks of pericardial effusion and associated cardiac tamponade. Patients developing these pericardial complications are at particularly high-risk for in-hospital mortality, greater LOS, and 30-day readmission.

Comparison of permanent pacemaker implantation rate after first and second generation of transcatheter aortic valve implantation-A retrospective cohort study.

This study aimed to compare permanent pacemaker implantation (PPMI) rates among patients undergoing Trans-catheter Aortic Valve Implantation (TAVI) with first generation (G1) versus second generation (G2) valves and the impact of PPMI on long-term mortality. PPMI is a known adverse event after TAVI. Recently, two novel iterations of valve designs of both the balloon expandable valves (BEV) and self-expanding valves (SEV) were introduced as a second generation valves. All patients included in the Israeli multicenter TAVI registry were grouped according to valve type (BEV vs. SEV) and generation (G1 vs. G2). A comparison was made for clinical and outcome indices of patients undergoing TAVI with G1 and G2 in each of the valve systems. A total of 1377 patients were included. The incidence of PPMI did not differ between G1-BEV versus G2-BEV (15.3% vs. 17.4%; p= 0.598) nor between G1-SEV versus G2-SEV (23.4% vs. 20.3%; p= 0.302). Depth of implantation and complete right bundle branch block were independently associated with PPMI post-TAVI in both valve systems. PPMI was not associated with an increased risk for 2-year mortality. The incidence of PPMI remains a relevant adverse event post-TAVI even when the newer generation valves are used. Since the predictors for PPMI are well established, a standardized approach for the management of conduction disorders is much needed.

P1136Is there a negative impact of permanent pacemaker implantation in long-term outcomes after transcatheter aortic valve implantation?

Abstract Introduction Transcatheter aortic valve implantation (TAVI) is an established treatment in patients (P) with aortic stenosis. Despite the continuous developments of this procedure, high-grade conduction disturbances requiring permanent pacemaker (PPM) implantation is still a major and common complication of TAVI. Furthermore, long-term chronic right ventricular pacing has been associated with negative effects on ventricular function and heart failure (HF). Aim to evaluate the long-term impact of PPM after TAVI focusing on mortality and HF hospitalization. Methods We retrospectively examined P who underwent TAVI with a self-expanding valve from 2009 to 2018 at our institution. All P had pre-procedural clinical evaluation, including ECG, cardiac computed tomographic angiography and transthoracic echocardiography. P with previous PPM were excluded. Results 265P (57% male, mean age 81.4 years, 20% with left ventricular ejection fraction &amp;lt;40%) were analysed. Mean STS score and mean Euroscore II were 6.33% and 7.07%, respectively. Mean transvalvular gradient was 52.78 mmHg and mean aortic valve area 0.67 cm2. Forty-seven P (17%) underwent PPM implantation during the first 30 days after TAVI. P requiring PPM had higher prevalence of diabetes mellitus, chronic renal disease, atrial fibrillation and right bundle branch block. During a mean follow-up of 20.3 months, post-TAVI PPM was associated with similar mortality rate (29.8% vs. 25.6%, HR 1.28, 95% CI 0.72-2.29, p = 0.42) and similar cardiovascular mortality (9.8% vs. 6.4%, HR 0.72, 95% CI 0.21-2.4, p = 0.59) compared to P without PPM. There were no significant differences in HF hospitalization (4.9% vs. 2.4%, p = 0.47). Kaplan-Meier curves of total mortality and cardiovascular mortality according to the need for PPM post-TAVI were similar. Conclusions In P submitted to TAVI, PPM implantation is a relatively common finding, not associated with higher risk of total mortality, cardiovascular mortality or HF hospitalization in a long-term follow-up.

Influence of permanent pacemaker implantation after transcatheter aortic valve implantation with new-generation devices.

ObjectivePermanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVI) is the most common complication after the procedure. PPMI rates remain high with the new-generation TAVI devices despite improved outcomes concerning paravalvular aortic regurgitation and vascular access complications. However, the impact of PPMI on mortality and clinical outcome is still a matter of debate, and data with new-generation devices on this matter are scarce. Therefore, we sought to analyse the influence of PPMI in patients treated with the new-generation devices on one-year outcome.MethodsWe enrolled 612 consecutive patients without prior pacemaker undergoing transfemoral TAVI with the new-generation devices. Patients with or without PPMI were compared with respect to clinical outcome within one year.ResultsPPMI was performed in 168 patients (24.4% of the overall study population). There was no significant difference in one-year outcome concerning all-cause mortality (PPMI vs. no-PPMI: 12.2% vs. 12.5%, p = 0.94), rate of major adverse events including cardiac, cerebral or valve-related events and bleeding complications (22.1% vs. 24.5%, p = 0.55) or need for rehospitalisation due to cardiac symptoms (16.1% vs. 18.1%, p = 0.63). In patients with reduced ejection fraction (<45%) there was also no impact of PPMI on one-year mortality (14.3% vs. 15.7%, p = 0.86). Furthermore, multivariate analysis did not reveal PPMI to be independently associated with one-year mortality (odds ratio 0.94, 95% confidence interval 0.50–1.74, p = 0.83).ConclusionsIn this large all-comers TAVI population with new-generation devices the need for postprocedural PPMI did not show a statistical significant impact on survival or combined endpoint of major adverse events within one year.

Association of Clinical and Economic Outcomes With Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement

The literature is inconsistent regarding the impact of permanent pacemaker implantation after transcatheter aortic valve replacement. To evaluate clinical and economic outcomes in patients who required permanent pacemaker implantation during the index hospitalization after transcatheter aortic valve replacement. This retrospective, population-based cohort study using data from a multicenter registry included patients who underwent a transcatheter aortic valve replacement procedure from April 1, 2010, to March 31, 2015, in Ontario, Canada, with follow-up to March 31, 2017. Patients who had a previously implanted permanent pacemaker or who died during the index hospitalization were excluded. Inverse probability of treatment weighting using the propensity score was used to adjust for baseline differences between the pacemaker and nonpacemaker groups. Patients received a permanent pacemaker during the index hospitalization after transcatheter aortic valve replacement. All-cause mortality, readmission, readmission for heart failure, emergency department visits, and cumulative 1-year health care costs. The study cohort consisted of 1263 patients (mean [SD] age, 82.3 [7.2] years; 595 [47.1%] female; 137 [10.8%] rural), of whom 186 (14.7%) required permanent pacemaker insertion during the index hospitalization after transcatheter aortic valve replacement. Mean follow-up was 990 days. After propensity score weighting, over the entire follow-up period, pacemaker implantation was associated with significantly higher all-cause mortality (43.9% vs 31.7%; hazard ratio [HR], 1.40; 95% CI, 1.01-1.94; P = .04), all-cause readmission (80.9% vs 70.6%; HR, 1.28; 95% CI, 1.15-1.43; P < .001), and emergency department visits (95.5% vs 87.3%; HR, 1.28; 95% CI, 1.08-1.52; P = .004). Pacemaker implantation was also associated with significantly greater readmission for heart failure (33.9% vs 19.1%; HR, 1.90; 95% CI, 1.53-2.36; P < .001). There were no statistically significant differences between groups in adjusted cumulative health care costs 1 year after discharge. New permanent pacemaker implantation after transcatheter aortic valve replacement was associated with significantly greater morbidity and mortality at long-term follow-up. However, this did not translate to a difference in cumulative health care costs after hospital discharge.

Incidence of arrhythmias and impact of permanent pacemaker implantation in hospitalizations with transcatheter aortic valve replacement.

This study sought to analyze in-hospital outcomes associated with preexisting and newly implanted permanent pacemaker (PPM) in patients who underwent transcatheter aortic valve replacement (TAVR). PPM implantation following the development of conduction abnormalities is a common adverse event following TAVR. Furthermore, PPM implantation rates are higher in TAVR hospitalizations compared with the surgical alternative, thus we have analyzed the predictors of pacing post-TAVR. We hypothesize that incidence of arrhythmias are high post-TAVR and have worse adverse outcomes after receiving PPM. The study population was identified from the National Inpatient Sample database between 2012 and 2014. TAVR population was identified using ICD-9-CM procedure codes 35.05 and 35.06. Hospitalizations were divided into 3 group: (1) with preexisting PPM, (2) with newly implanted PPM, and (3) without any PPM. Overall, 0.8% of hospitalizations presented with preexisting PPM and 23.7% of hospitalizations received new PPM. The overall incidence of atrial fibrillation was 44.5%, left bundle branch block 8.9%, complete atrioventricular block 9.5%, and right bundle branch block 2.7%. In-hospital mortality was higher in hospitalizations receiving PPM compared with those without (4.9% vs 4.0%; P = 0.05). Length of stay and cost were higher in the group receiving new PPM. Female sex, atrial fibrillation, left bundle branch block, and second-degree and complete atrioventricular block were significant predictors for receiving PPM after TAVR. A risk stratification for hospitalizations with conduction disorders is necessary to avoid longer hospital stays, added costs, and mortality. Further research is warranted to investigate additional predictors for PPM after TAVR.

Long-Term Outcomes in Patients With New Permanent Pacemaker Implantation Following Transcatheter Aortic Valve Replacement

ObjectivesThis study sought to evaluate the long-term clinical impact of permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR). BackgroundConduction disturbances leading to PPI are common following TAVR. However, no data exist regarding the impact of PPI on long-term outcomes post-TAVR. MethodsThis was a multicenter study including a total of 1,629 patients without prior PPI undergoing TAVR (balloon- and self-expandable valves in 45% and 55% of patients, respectively). Follow-up clinical, echocardiographic, and pacing data were obtained at a median of 4 years (interquartile range: 3 to 5 years) post-TAVR. ResultsPPI was required in 322 (19.8%) patients within 30 days post-TAVR (26.9% and 10.9% in patients receiving self- and balloon-expandable CoreValve and Edwards systems, respectively). Up to 86% of patients with PPI exhibited pacing >1% of the time during follow-up (>40% pacing in 51% of patients). There were no differences between patients with and without PPI in total mortality (48.5% vs. 42.9%; adjusted hazard ratio [HR]: 1.15; 95% confidence interval [CI]: 0.95 to 1.39; p = 0.15) and cardiovascular mortality (14.9% vs. 15.5%, adjusted HR: 0.93; 95% CI: 0.66 to 1.30; p = 0.66) at follow-up. However, patients with PPI had higher rates of rehospitalization due to heart failure (22.4% vs. 16.1%; adjusted HR: 1.42; 95% CI: 1.06 to 1.89; p = 0.019), and the combined endpoint of mortality or heart failure rehospitalization (59.6% vs. 51.9%; adjusted HR: 1.25; 95% CI: 1.05 to 1.48; p = 0.011). PPI was associated with lesser improvement in LVEF over time (p = 0.051 for changes in LVEF between groups), particularly in patients with reduced LVEF before TAVR (p = 0.005 for changes in LVEF between groups). ConclusionsThe need for PPI post-TAVR was frequent and associated with an increased risk of heart failure rehospitalization and lack of LVEF improvement, but not mortality, after a median follow-up of 4 years. Most patients with new PPI post-TAVR exhibited some degree of pacing activity at follow-up.

Long-term pacemaker dependency and impact of pacing on mortality following transcatheter aortic valve replacement with the LOTUS valve.

To determine permanent pacemaker (PPM) dependency following transcatheter aortic valve replacement (TAVR) with the Lotus™ valve system (Boston Scientific), and the impact of PPM implantation on long-term morbidity and mortality. Conduction abnormalities are among the most common complications following TAVR. Limited studies have assessed pacing dependency following TAVR. Consecutive patients (n = 166) with severe aortic stenosis who underwent TAVR with the Lotus valve system were prospectively recruited from a single-center. PPMs were implanted according to standard clinical criteria. Patients were followed in-hospital and at 1, 3, 6, and 12 months to determine pacemaker dependency and clinical outcomes. Fourteen patients with a pre-existing PPM (8%) were excluded with the remaining 152 patients aged 83.6 ± 5.6 years and 46% male. PPMs were implanted 3.8 ± 4 days post-TAVR in 38/152 patients (25%). Indication for PPM was complete heart block in 29 (76%) of patients. At 30-day and one-year follow up, 57% and 38% of patients were pacemaker dependent, respectively. The mean ventricular pacing percentage decreased in the first three months after PPM implantation and remained relatively stable after that. Only 38% of Lotus recipients who require a PPM following TAVR with the Lotus valve remain pacing dependent at one year.

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.