Requiring Permanent Pacemaker Implantation Research Articles

Association of cardiac amyloidosis with periprocedural complications in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement: a systematic review and meta-analysis

Abstract Introduction Cardiac amyloidosis (CA) has been frequently observed in patients with aortic stenosis (AS). While transcatheter aortic valve replacement (TAVR) may be an option, the association of CA with risk of periprocedural complications has not been well evaluated. Purpose This study aimed to evaluate the association of CA with periprocedural complications after TAVR in patients with severe AS. Methods A literature search was performed for studies evaluating patients with severe AS undergoing AVR, comparing periprocedural safety endpoints for patients with and without CA. The primary endpoints were vascular complications and bradyarrhythmias post-TAVR requiring permanent pacemaker (PPM) implantation. Secondary endpoints included periprocedural acute kidney injury (AKI), cerebrovascular accidents (CVA), and major bleeding events. Endpoints were defined using the Valve Academic Research Consortium-2 criteria. The search was not restricted to time or publication status. Results 6 studies with 1,138 patients with severe AS (150 with CA, 988 without CA) met inclusion criteria. Mean age was 82 years, 52.4% were men, all except 1 study assessed only patients with ATTR CA. Echocardiographic mean aortic valve parameters included valve area of 0.718 cm2, mean gradient of 40.8, and peak velocity of 4.13 m/s. The mean left ventricular ejection fraction was 55.2%. The presence of CA was not associated with an increased risk of periprocedural vascular complications (OR 0.69, 95% CI 0.25-1.88; p=0.47). While a trend toward higher risk of periprocedural PPM implantation was observed in patients with CA, this finding did not reach statistical significance (OR 1.51; 95% CI 0.77-2.94; p=0.23). The presence of CA was not associated with increased risk of periprocedural AKI, CVA, or major bleeding (OR 1.3, 95% CI 0.32-5.3; p=0.72, OR 0.65, 95% CI 0.17-2.41; p=0.52; OR 0.55, 95% CI 0.16-1.87; p=0.34). Conclusion In the context of patients with severe AS undergoing TAVR, the presence of cardiac amyloidosis did not increase the risk of periprocedural complications, including vascular complications, AKI, CVA, or major bleeding. Although a trend toward a higher risk of bradyarrhythmias requiring PPM implantation was noted in patients with CA, further studies are warranted to confirm this observation. Overall, these findings contribute valuable insight into the safety profile of TAVR in the patients with CA.Figure 1Figure 2

A single-center outcome of choosing catheter ablation as the initial treatment in tachycardia–bradycardia syndrome and a new predictive factor for pacemaker implantation

BackgroundThe relationship between sinus node dysfunction and atrial fibrillation (AF) has been well known. The reversibility of sinus node dysfunction is indeed a critical factor in determining the treatment strategy in patients with tachycardia–bradycardia syndrome (TBS). We aimed to assess the clinical outcome of choosing catheter ablation as the initial treatment in tachycardia–bradycardia syndrome and predictive factors leading to the implantation of a permanent pacemaker (PPM) in these patients.MethodsPatients with TBS who had been taken AF catheter ablation from 2012 to 2021 were reviewed, and 113 patients were enrolled. Patients were divided into two groups based on whether a “sinus pause episode of more than 3 s unrelated to tachyarrhythmia” coexists (Group I, n = 20) or not (Group II, n = 93).ResultsCompared to Group II, baseline characteristics showed that Group I was comprised of more female gender (p = 0.043), with hypertension (p = 0.033), and with enlarged left atrium (p = 0.003). An average three-year follow-up found that eight patients (8/113, 7%) were implanted PPM (5/20, 25% in Group I vs. 3/93, 3.2% in Group II, p = 0.001). Using a multivariate model, a “sinus pause episode unrelated to tachyarrhythmia” was strongly associated with PPM implantation after catheter ablation in patients with TBS (HR 6.765, 95% CI 1.355–33.763, p = 0.020). Only four out of 113 patients (3.5%) progressed to persistent or permanent AF.ConclusionsAfter catheter ablation as the initial treatment in TBS, only 7% underwent PPM implantation, and an isolated sinus pause was a predictive factor for requiring PPM implantation. In addition, even in patients who undergo catheter ablation with subsequent PPM implantation, we can expect to improve the clinical outcome associated with a reduced AF burden.

Reduction in pacemaker rates post-heart transplantation with use of organ preservation systems

Abstract Background Approximately 10% of heart transplant recipients require permanent pacemaker (PPM) implantation. (1) Prolonged graft ischaemic time may contribute to conduction system injury and PPM requirement. (2) Ex-vivo preservation of heart allografts at the time of organ retrieval, using either normothermic or hypothermic organ preservation systems (OPS), allows for the reduction of graft ischaemic time which can facilitate long-distance procurements and use of marginal donors including donation after circulatory death (DCD) donors. (3) Purpose We sought to determine if the use of organ preservation systems reduced PPM implantation in heart transplant recipients. Methods This was a single-centre retrospective study of 405 consecutive heart transplant recipients between July 2014 and March 2023. Baseline demographics, utilisation of organ preservation systems, donor ischaemic times, history of graft dysfunction, rejection and chronic allograft vasculopathy were obtained from the medical records. The primary outcome was PPM implantation. Results Of 405 heart transplants performed, an organ preservation system (OPS) was utilised in 118 (29.1%) patients. Normothermic OPS was used in 93/405 (23%) transplants, 90 of which were DCD transplants. Twenty-five of 405 (6.2%) transplants were performed using a hypothermic OPS to facilitate donation after brain death (DBD). The remaining 287 (70.9%) organs underwent cold ischaemic storage (CIS) from retrieval until transplant. Apart from male sex (81% in OPS group versus 69% in the CIS group), there were no significant differences in baseline demographics between the two groups (table 1). Two of 118 (1.7%) patients in the OPS group required PPM implantation, compared to 27/287 (9.4%) in the cold ischaemic storage group (Chi-Square 7.5, p = 0.006). Kaplan-Meier analysis (figure 1) demonstrates a significantly lower rate of PPM implantation in the OPS arm (Log Rank 6.975, p = 0.008). Of the 29 patients who required pacing, 12/29 (41.4%) had AV block and 17/29 (58.6%) had sinus node dysfunction. Thirteen of 29 patients (44.8%) required PPM implantation within 30 days of transplant. Six of 29 patients (20.7%) were pacing dependent at last follow up. Conclusion Heart transplants performed utilising an organ preservation system were associated with lower PPM rates.Table 1.Figure 1.

Calcification of aortic valve cusps as independent predictor for permanent pacemaker requirement after transcatheter aortic valve implantation

Abstract Background High-degree atrioventricular (AV) block represents a frequent complication after transcatheter aortic valve implantation (TAVI). Extension of indication for TAVI towards subjects with lower surgical risk requires to reduce the likelihood for the need of permanent pacemaker (PPM) implantation. Purpose We examined the role of calcification of the aortic valve cusps and left ventricular outflow tract (LVOT) as potential predictors for PPM implantation after TAVI. Methods In a cohort of 1200 consecutive patients without PPM who underwent transfemoral TAVI, clinical and procedural characteristics as well as requirement for PPM implantation after TAVI were assessed systematically. In all patients, cardiac computed tomography (CT) was performed before TAVI including quantitative assessment of calcium volume of the aortic valve cusps and the LVOT in mm3 (see figure). Results Median patient age was 81 (IQR 7) years, 50% were male. 9.8% of patients had a pre-existing complete right bundle branch block (RBBB) in ECG. 68% of subjects received a balloon-expandable valve, 32% a self-expandable valve. Postinterventional PPM implantation was necessary in n=155 subjects (13%) due to high-degree AV block. In this group of subjects, calcification of the aortic valve cusps was more pronounced than in the group of subjects without high-degree AV block (see table). Univariate regression analysis revealed pre-existing complete RBBB (p<0.001, OR 8.564), implantation of a self-expandable prosthesis (p=0.013, OR 1.549) as well as calcification of the non-coronary (p=0.016, OR 1.001) and left-coronary cusp (p=0.025, OR 1.001) as significant predictors for PPM implantation. In multivariate regression analysis, these predictors – including calcification of the non-coronary cusp (p=0.037, OR 1.001) remained significant. With every mm3 of calcification, risk for high-degree AV block and PPM implantation increases by 0.1%. With a median calcification of 225 mm3 of the non-coronary cusp, this would make a 22.5% relative risk increase. Conclusion In a large cohort of 1200 patients, the volume of aortic cusp calcification, in particular calcification of the non-coronary cusp, was identified as independent predictor for PPM implantation following transcatheter aortic valve implantation. This might be explained by the anatomical proximity of both the AV node and left Tawara branch to the non-coronary cusp, resulting in a higher risk of compression during valve implantation. Our results may contribute to improved risk stratification regarding the need for PPM implantation after TAVI.Assessment of calcium volumeComparison of calcification

Abstract 12786: Predictors of Intermediate to Long-Term Ventricular Pacing Requirement Following Transcatheter Aortic Valve Replacement

Objectives: To identify factors associated with persistent atrioventricular (AV) block in patients with permanent pacemaker (PPM) in the peri-transcatheter aortic valve replacement (TAVR) setting. Background: Patients undergoing TAVR may develop AV block requiring pacing. However, whether there are patients who recover AV conduction over time is unknown. Methods: Patients who underwent TAVR and either had pre-existing PPM implanted for sinus node dysfunction or required PPM implantation during the peri-procedural TAVR period were identified from two hospitals in the University of North Carolina Health system. Demographic, electrocardiographic, echocardiographic, and procedural characteristics were abstracted. PPM data was abstracted from remote and in-person PPM interrogations at intermediate (1-12 mo) and long-term (>12 mo) checks. Patients were separated into cohorts with negligible (<1%) or significant (>1%) ventricular pacing burdens. Bivariable and multivariable analyses were performed to identify factors associated with a significant ventricular pacing requirement. Results: The cohort consisted of 159 patients with PPM implanted prior to (n=38) or in the peri-procedural (n=121) TAVR period. Bivariate analyses identified pre-procedural RBBB (17.1% vs 42.9%, p=0.007) and post-procedural RBBB (15.2% and 39.3%, p=0.015) with significant ventricular pacing requirement in the intermediate or long-term period after TAVR. In multivariate analyses, atrial fibrillation (AF) (OR 5, 95% CI 1.78-16.6, p=0.003) and RBBB (OR 11, 95% CI 2.2-100.0, p=.008) in the post-TAVR period were associated with significant ventricular pacing requirements. Patients without AF or RBBB less often required significant ventricular pacing in the intermediate (19.3% vs 80.7%) or long-term periods (19.8% vs 80.2%) after TAVR. Conclusions: Post-procedure RBBB or a history of AF predict long-term persistence of AV block post-TAVR. However, patients without RBBB or AF less often require long-term ventricular pacing and may be candidates for temporary or more basic pacing options (e.g. leadless ventricular devices) as necessary in the peri-op period.

Permanent pacemaker implantation after alcoholic septal ablation induced complete heart block: Long-term impact

Introduction and objectivesPatients with hypertrophic obstructive cardiomyopathy (HOCM) that remain symptomatic despite optimized medical therapy often undergo alcohol septal ablation (ASA). One of the most frequent complications is complete heart block (CHB), requiring a permanent pacemaker (PPM) in variable rates of up to 20% of patients. The long-term impact of PPM implantation in these patients remains unclear. This study aimed to evaluate the long-term clinical outcomes in patients who implant PPM after ASA. MethodsPatients who underwent ASA at a tertiary center were consecutively and prospectively enrolled. Patients with previous PPM or implantable cardio-defibrillator were excluded from this analysis. Patients with and without PPM implantation after ASA were compared based on their baseline characteristics, procedure data and three-year primary endpoint of composite of all-cause mortality and hospitalization and secondary endpoint of composite of all-cause mortality and cardiac cause hospitalization. ResultsBetween 2009 and 2019, 109 patients underwent ASA, 97 of whom were included in this analysis (68% female, mean age 65.2 years old). 16 patients (16.5%) required PPM implantation for CHB. In these patients, no vascular access, pacemaker pocket or pulmonary parenchyma complications were noted. The baseline characteristics of comorbidities, symptoms, echocardiographic and electrocardiographic findings were identical in the two groups, with higher mean age (70.6±10.0 years vs. 64.1±11.9 years) and lower beta-blocker therapy rate (56% vs. 84%) in the PPM group. Procedure-related data showed higher creatine kinase (CK) peaks in the PPM group (1692 U/L vs. 1243 U/L), with no significant difference in the alcohol dose. At three years after ASA procedure, there were no differences in the primary and secondary endpoints between the two groups. ConclusionsPermanent pacemaker after ASA induced CHB do not affect long term prognosis in hypertrophic obstructive cardiomyopathy patients.

Long-term impact of pacemaker implantation after TAVI: a subgroup analysis according to previous intraventricular conduction disturbances

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Transcatheter aortic valve implantation (TAVI) is a worldwide accepted treatment for severe aortic stenosis (AS). Conduction system disturbances, frequently requiring permanent pacemaker (PM) implantation, remain one of the most common procedural complication. Whether the permanent ventricular pacing has a deleterious impact on the prognosis of this population remains unclear. Objectives To assess the long-term impact of permanent PM implantation in clinical outcomes after TAVI. Methods We performed a retrospective analysis of consecutive patients (P) who underwent TAVI between 2009 and 2021 in a single tertiary center.P with a PM implanted before TAVI or with in-hospital mortality were excluded from the analysis. PM implantation post-TAVI was defined as an implant during hospital stay after TAVI or in the first month after discharge. Kaplan Meier survival curves were used to estimate the impact of permanent PM after TAVI, regarding the composite endpoint of all-cause mortality and heart failure (HF) hospitalization during a 4 years follow-up period, and a comparison performed according to the presence or absence of baseline intraventricular conduction disturbances. Results 549 P (82±6.6 years, 56.8% female, left ventricular ejection fraction 53±10%, peak gradient 51±15.6 mmHg, aortic valve area 0.7± 0.2 cm2) were included. At baseline, 108 P (20%) had intraventricular conduction disturbances on ECG (50 P with right bundle branch block [RBBB] and 58 P with left bundle branch block [LBBB]). 127 P (23%) required PM implantation after TAVI. Baseline characteristics were similar between P with and without PM implantation, except for age, gender, previous valvular surgery and RBBB (Table 1). At 48 months follow-up, 35% (n=193) met the composite endpoint, that was similar between both groups (35.8% vs. 34.1%, p=0.731). Kaplan-Meier survival curves revealed no difference in the composite endpoint between the two groups (log-rank p=0.170). Further analysis of subgroups according to the presence or absence of baseline intraventricular conduction disturbances revealed a significant difference among the subgroup of P without previous intraventricular conduction disturbances that underwent PM implantation after TAVI (log rank p=0.02) (Fig 1). This difference in the composite endpoint after PM was not found in the subgroups of P with RBBB (log rank p=0.656) or LBBB (log rank p=0.975) at baseline (Fig 2).* Conclusions Permanent PM implant after TAVI does not have an impact on long-term HF hospitalization and mortality. However, in the specific subgroup of P without previous intraventricular conduction disturbances, PM implantation seems to be associated with worse prognosis.

PO-05-022 OUTCOMES FOR POST-TRANSCATHETER AORTIC VALVE REPLACEMENT CONDUCTION ABNORMALITIES WITHOUT CLEAR INDICATION FOR PERMANENT PACING

Patients undergoing transcatheter aortic valve replacement (TAVR) often develop conduction abnormalities in the postprocedural period. While high-grade AV block (HAVB), which includes 3rd degree & 2nd degree type 2 Mobitz AV block, is a clear indication for permanent pacemaker (PPM) implantation, other conduction abnormalities do not have a clear indication for PPM. Outcomes and predictors for subsequent PPM in this population is lacking. To investigate outcomes of non-HAVB conduction abnormalities in the immediate post-TAVR setting. We conducted a single-center retrospective study on patient characteristics and outcomes of patients without PPM who underwent TAVR between June 2020 and March 2022 that developed non-HAVB conduction abnormalities without a clear indication for pacing (Table 1A). All these patients received thirty-day ambulatory event monitoring (AEM) at discharge. A total of a hundred and sixty patients underwent TAVR; thirteen patients outright received a new PPM for HAVB while thirty-six patients developed non-HAVB and were discharged with AEM. Mean age was 79.8 ± 6.1 years, mean ejection fraction (EF) was 62.1 ± 9.1%, mean maximum aortic valve velocity was 3.9 ± 0.5 m/sec, average mean gradient across the valve was 36.8 ± 10.0 mmHg, and mean aortic valve area was 0.76 ± 0.18 cm2 for these patients. Among the patients who developed non-HAVB conduction abnormalities after TAVR, four subsequently required PPM implantation. Pre-existing right bundle branch block (RBBB) was more frequent in the group requiring eventual PPM vs. the group not requiring PPM (Table 1B). There were no statistically significant differences between several electrocardiogram metrics, demographics, and valve measurements, outlined in Table 1B. Details of those who received subsequent PPM can be found in Table 1C. Of patients who developed persistent non-HAVB conduction abnormalities in the immediate post-TAVR setting the incidence of pre-existing RBBB was higher in patients who required eventual permanent pacing versus those who did not require eventual permanent pacing.

Comparison of in-hospital outcomes and long-term survival for valve-in-valve transcatheter aortic valve replacement versus the benchmark native valve transcatheter aortic valve replacement procedure.

In recent years, the number of patients with failed surgically implanted aortic bioprostheses and the number of candidates for valve-in-valve transcatheter aortic valve replacement (VIV-TAVR) have been increasing. The purpose of this study is to evaluate the efficacy, safety, and long-term survival outcomes of VIV-TAVR compared with the benchmark native valve transcatheter aortic valve replacement (NV-TAVR). A cohort study was conducted on patients who underwent TAVR in the department of cardiology at Toulouse University Hospital, Rangueil, France between January 2016 and January 2020. The study population was divided into two groups: NV-TAVR (N = 1589) and VIV-TAVR (N = 69). Baseline characteristics, procedural data, in-hospital outcomes, and long-term survival outcomes were observed. In comparison with NV-TAVR, there are no differences in TAVR success rate (98.6 vs. 98.8%, p = 1), per-TAVR complications (p = 0.473), and length of hospital stay (7.5 ± 50.7 vs. 4.4 ± 2.8, p = 0.612). The prevalence of in-hospital adverse outcomes did not differ among study groups, including acute heart failure (1.4 vs. 1.1%), acute kidney injury (2.6, 1.4%), stroke (0 vs. 1.8%, p = 0.630), vascular complications (p = 0.307), bleeding events (0.617), and death (1.4 vs. 2.6%). VIV-TAVR was associated with a higher residual aortic gradient [OR = 1.139, 95%CI (1.097-1.182), p = 0.001] and a lower requirement for permanent pacemaker implantation [OR = 0.235 95%CI (0.056-0.990), p = 0.048]. Over a mean follow-up period of 3.44 ± 1.67 years, no significant difference in survival outcomes has been observed (p = 0.074). VIV-TAVR shares the safety and efficacy profile of NV-TAVR. It also represents a better early outcome but a higher non-significant long-term mortality rate.

909 TIMING AND DETERMINANTS OF PERMANENT PACEMAKER IMPLANTATION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT: IS THE NEW GENERATION BETTER?

Abstract Background conduction disturbances requiring permanent pacemaker (PPM) implantation are among the most common adverse events in patients undergoing transcatheter aortic valve replacement (TAVR). The introduction in clinical practice of a new generation of TAVR devices has contributed to a significant reduction in procedural complications. However, limited data is available regarding the usual timing of PPM implantation after TAVR with the latest available valves. Therefore, in this analysis, we aimed to investigate the incidence, risk factors, and timing of new permanent pacemakers after TAVR, with respect to the type of valve implanted. Methods Patients who underwent TAVR at our Institution from September 2008 to June 2022 were included in this analysis. Patients with previous PPM/ICD implantation or receiving only balloon angioplasty were excluded, as well as cases with procedural unsuccess. The independent association between baseline clinical and procedural variables and the occurrence of PPM implantation was investigated with cross-sectional logistic regression analysis. Results A total of 497 patients were included in the study, with a mean age of 80.4±5.6 years old; 59% were females, 37.2% of patients had diabetes, 60.2% had dyslipidemia, and 25.8% had chronic kidney disease. The mean left ventricular ejection fraction (LVEF) was 52.1%, and the mean Euroscore II was 7.7±5.1. The new generation of self-expandable valves was used in 280 (56.3%) patients, while the new generation of balloon-expandable devices was implanted in 118 (23.7%). After TAVR, 109 (21.3%) patients underwent PPM/ICD implantation after a mean time of 4.1±3.1 days. After adjustment, self-expandable devices, larger valve sizes (29 or 34 mm), and diabetes were significantly associated with PPM/ICD implantation. Of note, the new generation of valve devices was associated with a lower risk of PPM/ICD implantation. Conclusion The necessity for a permanent pacemaker is a well-known possible adverse effect after TAVR. In this analysis, we confirm the previous evidence of an increasing risk of PPM implantation with self-expandable compared to balloon-expandable devices. Interestingly, the new valve generation was associated with a lower risk of conduction disturbances requiring PPM implantation. Further analyses and investigations will be needed to assess the impact of developing interventional techniques and advanced technologies on the occurrence of conduction disturbances.

Trends and In-Hospital Outcomes of Patients With Baseline Right Bundle Branch Block Who Underwent Transcatheter Aortic Valve Implantation

This study aimed to explore contemporary in-hospital outcomes and trends of transcatheter aortic valve implantation (TAVI) outcomes in patients with baseline right bundle branch block (RBBB) using data collected from a nationwide sample. Using the National Inpatient Sample, we identified patients hospitalized for an index TAVI procedure from 2016 to 2019. Primary outcomes included in-hospital all-cause mortality, complete heart block, and permanent pacemaker (PPM) implantation. A total of 199,895 hospitalizations for TAVI were identified. RBBB was present in 10,495 cases (5.3%). Patients with RBBB were older (median age 81 vs 80years, p <0.001) and less likely to be female (35% vs 47.4%, p <0.001). After adjusting for differences in baseline characteristics and elective versus nonelective admission, patients with RBBB had a higher incidence of complete heart block (adjusted odds ratio [aOR] 4.77, confidence interval [CI] 4.55 to 5.01, p <0.001) and PPM implantation (aOR 4.15, CI 3.95 to 4.35, p <0.001) and no difference in-hospital mortality rate (aOR 0.85, CI 0.69 to 1.05, p=0.137). Between 2016 and 2019, there was a 3.5% and 2.9% decrease in in-hospital PPM implantation in patients with and without RBBB, respectively. In conclusion, from 2016 to 2019, the rate of in-hospital PPM implantation decreased during index TAVI hospitalization in both patients with and without RBBB. However, in those with baseline RBBB, complete heart block complication rates requiring PPM implantation remain relatively high. Further research and advances are needed to continue to reduce complication rates and the need for PPM implantation.

3 year outcomes of permanent pacemaker implantation after alcoholic septal ablation

Abstract Introduction Patients with hypertrophic obstructive cardiomyopathy (HOCM) that remain symptomatic despite optimized medical therapy are often submitted to alcohol septal ablation (ASA). One of the most frequent complications is the complete hear block (CHB), requiring permanent pacemaker (PPM) in variable rates, up to 20% of the patients. The long-term impact of PPM implantation in these patients remains unclear. Objectives This study aims to evaluate the long-term clinical outcomes in patients who implant PPM after ASA. Methods In a tertiary center, patients who underwent ASA were consecutively enrolled prospectively. Patients with previous PPM or implantable cardio-defibrillator were from this analysis. The groups with and without PPM implantation after ASA were compared regarding baseline characteristics, procedure data and 3-year primary and secondary endpoints. Results Between 2009 and 2020, 109 patients underwent ASA. 97 patients were included in this analysis (68% female, mean age 65.2 years-old). 16 patients (16.5%) required PPM implantation for CHB. In those, no vascular access, pacemaker pocket or pulmonary parenchyma complications were noted. The baseline characteristics regarding comorbidities, symptoms, echocardiographic and electrocardiographic findings were identical in the two groups, with statistically significant differences in the mean age (70.6y/o in the PPM group versus 64.1y/o) and in the beta-blocker therapy rates previously to the intervention (56% in the PPM group versus 84%). Procedure-related data showed higher creatine kinase (CK) peaks in the PPM group (1692U/L versus 1243U/L, p0.05), without significant differences in the alcohol dose (2.1ml in both groups, p0.33). At 3 years after ASA procedure, the primary endpoint (composite of all-cause mortality and all-cause re-hospitalization) showed a statistical tendency to a lower event rate in the group who implanted PPM (p-value 0.097, Graphic 1). The secondary endpoint (composite of all-cause mortality and cardiac cause re-hospitalization) did not show any significant statistical difference between the two groups (p-value 0.216, Graphic 2). Conclusions The long-term endpoint analysis suggests that the outcomes in patients who implant PPM after ASA are non-inferior to those who do not, with a tendency to a lower rate of the endpoint composite of all-cause mortality and all cause re-hospitalizations. Funding Acknowledgement Type of funding sources: None.

Permanent pacing in a very long-term follow-up after orthotopic heart transplantation: A matter of when or why?

BackgroundOrthotopic heart transplantation (OHT) is associated with a high incidence of conduction disturbances (CD) leading to permanent pacemaker (PPM) implantation. However, the improved posttransplant survival raises the question about the pacemaker dependence (PD) in a prolonged follow‐up.HypothesisThe prevalence of PPM in OHT is high but not all patients are PD in a very long‐term follow‐up. Device implantation has no prognostic relevance.MethodsWe performed a retrospective analysis of patient medical records focusing on device interrogation data at the most recent follow‐up.ResultsThe study population consisted of 183 patients with a mean follow‐up of 15.0 ± 6.8 years. One‐fourth of the patients had undergone PPM implantation (n = 49, 26.8%). Among these, two‐thirds were PD at last follow‐up (n = 32, 65.3%). PPM was more often in biatrial OHT and cardiac allograft vasculopathy (OR 3.0, 95% CI 1.26–7.29, p = .013 and OR 2.0, 95% CI 1.03–3.87, p = .041, respectively). Early sinus node dysfunction (SND) was the most persistent CD. PPM was associated with a poorer outcome in OHT (HR 1.9, 95% CI 1.06–3.46, p = .031) and a higher rate of fatal septicemia (HR 5.1, 95% CI 1.41–18.14, p = .013).ConclusionsOne‐fourth of the OHT recipients develop CD requiring PPM implantation, although one‐third among these are not PD in follow‐up. Early SND is associated with a higher rate of PD. PPM is associated with an inferior prognosis.

Incidence, predictors and prognostic value of permanent pacemaker implantation following sutureless valve implantation in low-risk aortic stenosis patients.

Sutureless aortic valve replacement (SU-SAVR) has been associated with higher rates of permanent pacemaker (PPM) compared with conventionally implanted aortic bioprostheses. The purpose of this study was to determine the incidence, predictors and mid-term prognostic impact of PPM after Perceval (Livanova, London, UK) SU-SAVR in low-risk patients. A total of 400 consecutive low-risk (EuroSCORE II < 4%) patients without prior pacemaker who underwent surgical aortic valve replacement with the Perceval prosthesis from 2013 to 2019 in 2 centres were included. Baseline, clinical and electrocardiographic parameters, procedural characteristics and follow-up data were collected. PPM was required in 36 (9%) patients after SU-SAVR, with a median time between the procedure and PPM implantation of 7.5 (4.5-10.5) days. Older age and prior right bundle branch block (RBBB) were associated with an increased risk of PPM (P < 0.05 for all), but only baseline RBBB was found to be an independent predictor of new PPM requirement (odds ratio: 2.60, 95% confidence interval: 1.15-5.81; P = 0.022). At a median follow-up of 3.4 (2.3-4.5) years, there were no differences between groups in mortality (PPM: 36%, no PPM: 22%, P = 0.105) or heart failure rehospitalization (PPM: 25%, no PPM: 21%, P = 0.839). About 1 out of 10 low-risk patients with aortic stenosis undergoing SU-SAVR with the Perceval prosthesis required PPM implantation. Prior RBBB determined an increased risk (close to 3-fold) of PPM following the procedure. PPM was not associated with a higher risk of clinical events at 3-year follow-up.

Permanent pacemaker implantation after Alcoholic Septal Ablation: long-term outcomes

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Patients with hypertrophic obstructive cardiomyopathy (HOCM) that remain symptomatic despite optimized medical therapy are often submitted to alcohol septal ablation (ASA). One of the most frequent complications is the complete heart block (CHB), requiring permanent pacemaker (PPM) in variable rates, up to 20% of the patients. The long-term impact of PPM implantation in these patients remains unclear. Objectives This study aims to evaluate the long-term pacemaker dependency in patients with PPM after ASA and to assess the long-term impact of PPM in these patients. Methods In a tertiary center, patients who underwent ASA were retrospectively analyzed. Patients with previous PPM or implantable cardio-defibrillator were excluded. The groups with and without PPM implantation after ASA were compared regarding baseline characteristics, procedure data and outcomes. In the group who implanted PPM, the long-term pacing rates were evaluated. Results Between 2009 and 2020, 109 patients underwent ASA. 97 patients were included in this analysis (68% female, mean age 65.2 years-old). 16 patients (16.5%) required PPM implantation for CHB. In those, no vascular access, pacemaker pocket or pulmonary parenchyma complications were noted. The baseline characteristics regarding co-morbidities, symptoms, echocardiographic and electrocardiographic findings were identical in the two groups, with statistically significant differences in the mean age (70.6y/o in the PPM group versus 64.1y/o) and in the beta-blocker therapy rates previously to the intervention (56% in the PPM group versus 84%). Procedure-related data showed higher creatine kinase (CK) peaks in the PPM group (1692U/L versus 1243U/L, p0.05), without significant differences in the alcohol dose (2.1ml in both groups, p0.33). In the PPM group, the mean pacing rates at 1 month, 1 year and 2 years were 66.6±38.0, 50.4±44.1 and 50.8±42.5, respectively, with 2 patients (12.5%) having 1-5% pacing and none having pacing &amp;lt;1% at 2 years. In the group without PPM, 5 patients (6.2%) required posteriorly PPM implantation during the follow-up. There were no statistically significant differences in the two groups regarding in-hospital mortality, 1 year mortality or 1 year re-hospitalization. Despite a lower mean follow-up period in the PPM group (2.3±1.5 years versus 3.5±2.2 years, p0.05), there were no differences in the groups regarding all-cause mortality, cardiac cause mortality and cardiac cause re-hospitalization, with a statistical tendency to a lower all cause re-hospitalization in the PPM group (19% versus 43%, p0.07). Conclusions The registered pacing rates shows that all devices were adequately implanted. The long-term impact analysis suggests that the outcomes in patients who implant PPM after ASA are non-inferior to those who do not, with a tendency to reduce all cause re-hospitalizations.

Risk factors for atrioventricular block after occlusion for perimembranous ventricular septal defect.

The risk factors for complete atrioventricular block (CAVB) after device closure of perimembranous ventricular septal defect (pmVSD) remain unclear. The purpose of this study was to analyze the incidence and risk factors for CAVB after device closure for pmVSD. We reviewed 1884 patients with pmVSD who had undergone successful device occlusion between June 2005 and January 2020. Permanent CAVB was defined as CAVB requiring implantation of a permanent pacemaker (PPM) or extraction of the occluder. In total, 14 patients (0.7%) developed permanent CAVB. Of these patients, 10 (0.5%) required PPM implantation. Four permanent CAVB occurred within 7 days after the procedure (acute), 2 between 7 and 30 days (subacute), 3 between 30 days and 1 year (late), and 5 more than 1 year (very late). None of the subacute, late, and very late CAVB recovered normal conduction with medication and eventually required device removal or PPM implantation. Four patients with acute CAVB and 1 with subacute CAVB underwent device removal, and 4 (80%) recovered normal conduction. Multivariate regression revealed that the ratio of device to defect size was the only independent risk factor for permanent CAVB (odds ratio 3.027; 95% confidence interval 1.476-6.209; P = .003). The incidences of permanent CAVB after occlusion for pmVSD and PPM implantation were 0.7% and 0.5%, respectively. The ratio of device to defect size was the only independent risk factor for permanent CAVB. Device removal is an effective therapeutic modality for recovering normal conduction in acute and subacute CAVB patients.

Same-Day Discharge Post-Transcatheter Aortic Valve Replacement During the COVID-19 Pandemic: The Multicenter PROTECT TAVR Study.

ObjectivesThe aim of this study was to determine the safety and efficacy of same-day discharge (SDD) after transcatheter aortic valve replacement (TAVR) during the COVID-19 pandemic.BackgroundThe COVID-19 pandemic has placed significant stress on health care systems worldwide. SDD in highly selected TAVR patients can facilitate the provision of essential cardiovascular care while managing competing COVID-19 resource demands.MethodsPatient selection for SDD was at the discretion of the local multidisciplinary heart team, across 7 international sites. The primary outcome was a composite of cardiovascular death, stroke, myocardial infarction, all-cause readmission, major vascular complications, and new permanent pacemaker (PPM) implantation.ResultsFrom March 2020 to August 2021, 124 of 2,100 patients who underwent elective transfemoral TAVR were selected for SDD. The average age was 78.9 ± 7.8 years, the median Society of Thoracic Surgeons score was 2.4 (IQR: 1.4-4.2), and 32.3% (n = 40) had preexisting PPMs. There were no major vascular complications, strokes, or deaths during the index admission. One patient (0.8%) required PPM implantation for complete heart block and was discharged the same day. No patient required a PPM between discharge home and 30-day follow-up. The composite of cardiovascular death, stroke, myocardial infarction, all-cause readmission, major vascular complications, and new PPM at 30 days occurred in 5.7% patients (n = 6 of 106).ConclusionsSDD post-TAVR is safe and feasible in selected patients at low risk for adverse clinical events postdischarge. This strategy may have a potential role in highly selected patients even when the COVID-19 pandemic abates.

Comparative characteristics of a pacemaker implantation after biatrial or left atrial ablation of atrial fibrillation in combination with coronary artery bypass grafting in patients with ischemic heart disease and long-standing persistent atrial fibrillation.

Aim To compare the incidence of a permanent pacemaker (PP) implantation based on the chosen treatment technology (biatrial ablation, BA, or left atrial ablation (LAA) for long-standing persistent atrial fibrillation (AF) with simultaneous coronary bypass (CB).Material and methods The study included 116 patients with long-standing persistent AF and indications for CB. Patients were randomized to two equal groups (58 patients in each). Group 1 underwent BA in combination with CB; group 2 patients underwent isolated LAA with simultaneous CB under the conditions of artificial circulation. Incidence of PP implantation was assessed during the early (to 30 days) and late (to 60 months) postoperative periods.Results For the observation period, a total of 9 PPs was implanted in both groups, 6 in the BA group and 3 in the LAA group (odds ratio, OR, 0.5; 95 % confidence interval, CI, 0.1-2.4; р=0.490). During the early postoperative period, 5 patients in the BA group and 2 patients in the LAA group were implanted with PP (OR, 0.4; 95 % CI. 0-2.5; р=0.438). During the late postoperative period, one (2%) patient of the BA group was implanted with a permanent PP at 30 months of follow-up due to the development of sick sinus syndrome (SSS); also, one (2%) patient of the LAA group required PP implantation at 54 months of follow-up due to the development of SSS. The causes for PP implantation in the BA group included the development of complete atrioventricular (AV) block in 9 % of cases (95 % CI, 4-19 %); sinus node dysfunction and junctional rhythm in 2 % of cases (95 % CI, 0-9 %). Compared to this group, the LAA group showed a statistically significant difference in the incidence of AV block (0 cases, р=0.047). The major cause for PP implantation in the LAA group was the development of sinus node dysfunction in 3 (5 %) patients (95 % CI, 2-14 %).Conclusion The use of BA in surgical treatment of long-standing persistent AF with simultaneous myocardial revascularization is associated with a high risk of AV block, which requires permanent PP implantation in the postoperative period. Total incidence of permanent PP implantation for dysfunction of the cardiac conduction system following the combination surgical treatment of long-standing persistent AF and IHD, either CB and LAA or BA, did not differ between the treatment groups both in early and late postoperative periods.

Prognostic impact of percentage of ventricular pacing in patients requiring pacemaker implantation after transcatheter aortic valve replacement

Abstract Background Despite the continuous developments of transcatheter aortic valve implantation (TAVI), around 15% of the patients (P) who undergo this procedure require permanent pacemaker (PM). Right ventricular pacing (RVP), particularly with a cumulative percentage of ventricular pacing (CVp) above 40%, has been associated with detrimental effects on ventricular function and an increased risk of cardiovascular events in non-TAVI patients. Aim To evaluate the long-term prognostic significance of RVP, regarding overall mortality and the combined endpoint of overall mortality/heart failure hospitalization in P requiring a PM after TAVI. Methods We retrospectively examined P who underwent TAVI with a self-expanding valve from 2009 to 2020 at our institution. All P had pre-procedural clinical evaluation, cardiac computed tomographic angiography, transthoracic echocardiography and electrocardiography performed. CVp was determined from stored PM data. P with previous PM were excluded. Post-TAVI PM implantation was defined as a device implantation during hospital stay or during the first month after discharge. Results 474P, 57% male, mean age 81.7±6.5 years with a mean left ventricular ejection fraction of 51.5±14.6% were analysed. Mean follow-up was 18.7 months. Mean STS score and mean Euroscore II were, respectively, 6.89% and 5.76%. Mean gradient was 51.67 mmHg and mean aortic valve area 0.71 cm2. After TAVI, 104P (21.9%) required PM implantation, with a mean CVp of 65.3±43.4%. Post-TAVI PM was not associated with a worse outcome - overall mortality: HR 1.13, 95% CI 0.72 – 1.78, p=0.57; combined mortality/heart failure hospitalization: HR 1.22, 95% CI 0.87 – 1.70, p=0.24. The follow-up Kaplan-Meier curves according to the need for PM post-TAVI were similar: log rank p=0.24. A CVp cut-off of 40% was not associated with any of the study endpoints - overall mortality: HR 1.72, 95% CI 0.38–7.86, p=0.48; combined mortality/heart failure hospitalization: HR 1.32, 95% CI 0.45–3.91, p=0.61. Also, a CVp cut-off of 40% did not provide an accurate risk stratification as survival free of events was similar between these P and those below this cut-off (log rank p=0.11) and in comparison, with P without PM (log rank p=0.65). Conclusions In P submitted to TAVI with a self-expanding valve, the need for PM implantation is common, but not associated with increased risk of total mortality or heart failure hospitalization during a 18 months follow-up period. A CVp cut-off of 40% showed poor discriminative ability regarding long-term events in this population. Funding Acknowledgement Type of funding sources: None.

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.