Permanent Pacemaker Implantation Research Articles

EVALUATION OF EARLY OUTCOMES OF PERMANENT PACEMAKER IMPLANTATION IN HYPERTENSIVE PATIENTS WITH BRADYARRHYTHMIAS

Objective: This study aims to describe the clinical characteristics and the features of bradyarrhythmias on 24-hour Holter monitoring and to evaluate the early outcomes of permanent pacemaker implantation in hypertensive patients with bradyarrhythmias. Subjects and method: This cross-sectional study was conducted on 57 subjects with hypertension and bradyarrhythmias who were indicated for permanent pacemaker implantation. Results: The most common clinical symptoms recorded were fatigue, dizziness, and chest pain, accounting for 47.4%, 45.6%, and 42.1% respectively. The majority of patients had sinus node dysfunction (73.7%) and most underwent dual-chamber permanent pacemaker implantation (87.7%). The 24-hour Holter monitoring results showed that 42.1% had sinus atrial block - sinus pause in the sinus node dysfunction group and 15.8% of patients had third-degree atrioventricular block (AV block) in the AV block group. A good treatment outcome was observed in 72.0% of cases. Age > 70 (OR: 6.1; 95% CI: 1.2-30.1), female gender (OR: 4.2; 95% CI: 1.2-15.4), and single-chamber pacemaker (OR: 8.9; 95% CI: 1.5-52.1) were associated with a higher risk of moderate to poor treatment outcomes. Conclusion: Permanent pacemaker implantation generally tends to have good short-term outcomes. However, it should be noted that older age, female, and single-chamber pacemaker implantation in association with worse outcomes.

Comparison between catheter ablation versus permanent pacemaker implantation as an initial treatment for tachycardia–bradycardia syndrome patients: a prospective, randomized trial

BackgroundClinical outcomes after catheter ablation (CA) or pacemaker (PM) implantation for the tachycardia–bradycardia syndrome (TBS) has not been evaluated adequately. We tried to compare the efficacy and safety outcomes of CA and PM implantation as an initial treatment option for TBS in paroxysmal atrial fibrillation (AF) patients.MethodsSixty-eight patients with paroxysmal AF and TBS (mean 63.7 years, 63.2% male) were randomized, and received CA (n = 35) or PM (n = 33) as initial treatments. The primary outcomes were unexpected emergency room visits or hospitalizations attributed to cardiovascular causes.ResultsIn the intention-to-treatment analysis, the rates of primary outcomes were not significantly different between the two groups at the 2-year follow-up (19.8% vs. 25.9%; hazard ratio (HR) 0.73, 95% confidence interval (CI) 0.25–2.20, P = 0.584), irrespective of whether the results were adjusted for age (HR 1.12, 95% CI 0.34–3.64, P = 0.852). The 2-year rate of recurrent AF was significantly lower in the CA group compared to the PM group (33.9% vs. 56.8%, P = 0.038). Four patients (11.4%) in the CA group finally received PMs after CA owing to recurrent syncope episodes. The rate of major or minor procedure related complications was not significantly different between the two groups.ConclusionCA had a similar efficacy and safety profile with that of PM and a higher sinus rhythm maintenance rate. CA could be considered as a preferable initial treatment option over PM implantation in patients with paroxysmal AF and TBS.Trial registrationKCT0000155.

Urgent transcatheter aortic valve implantation (TAVI) is associated with increased in-hospital mortality: a systematic review and meta-analysis

Abstract Funding Acknowledgements None. Introduction Transcatheter Aortic Valve Implantation (TAVI) is recommended for patients suffering from severe aortic stenosis (AoS) as an elective procedure. Taking into consideration that AoS is associated with acute heart failure and cardiogenic stroke resistant to pharmacotherapy, urgent TAVI might be a therapeutic option. However, a few data exist regarding its safety and efficacy against this background. Purpose Aim of our systematic review and meta-analysis is to compare in-hospital mortality among patients undergoing urgent and elective TAVI. Methods We systematically screened three major databases (Medline, Cochrane Central Register of Controlled Trials and Scopus) searching for studies comparing urgent versus elective TAVI. Primary endpoint of our systematic review and meta-analysis is the in-hospital mortality. Only studies provided data about in-hospital mortality were considered for our analysis. Secondary endpoints included acute kidney injury (AKI), permanent pacemaker implantation (PPM) and ischemic stroke. All the secondary endpoints were evaluated during the first 30-days after TAVI. Risk ratio (RR) was calculated with 95% confidence intervals (CIs) and a random-effects model (Mantel-Haenzel) was used to estimate the pooled RR. Results Twelve studies, all retrospective except one, published between 2014 and 2023 were included in our analysis. A total of 133,348 patients undergoing TAVI were included in our analysis; 110,606 had elective procedure and the 22,742 urgent intervention. Mortality rate was 5.1% in urgent and 2.2% in elective group. The risk of mortality is 2.38 times higher in the urgent TAVI group compared to the elective TAVI group (RR: 2.38, 95% CI: 1.80, 3.15). Data about AKI, PPM and stroke during the first 30-days were available for 12, 11 and 11 studies, respectively. The risk for AKI is significantly higher in patients having undergone urgent TAVI (RR: 2.10, 95% CI:1.62, 2.73). No significant differences were observed in stroke incidence (RR: 1.07, 95% CI: 0.97, 1.18) and PPM (RR: 1.05, 95%CI: 0.99, 1.11) during 30-days follow-up. Conclusion To the best of our knowledge, this is the first systematic review and meta-analysis showing that urgent TAVI is associated with significantly higher in-hospital mortality rates, compared to elective TAVI. Given these results, it is advisable to prefer an elective procedure, prior disease's worsening, in order to prevent the increased risk of in-hospital mortality associated with urgent TAVI.In-hospital mortality

Urgent transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis is associated with increased 30-days mortality: a systematic review and meta-analysis

Abstract Funding Acknowledgements None. Introduction In patients with severe symptomatic aortic stenosis (AS), transcatheter aortic valve replacement (TAVR) has emerged as a safe and effective therapeutic option; yet, 20% of these patients' hospitalizations are related to acute decompensation. The vast majority of TAVR procedures conducted across the US are elective procedures on patients who are hemodynamically stable. Despite that, according to recent research, urgent TAVR may be a feasible option for AS patients experiencing acutely decompensated heart failure or cardiogenic shock. Additionally, there is also a gap in the guidelines concerning the interventions in this acute setting, with only a brief recommendation for aortic balloon valvuloplasty as a bridge to TAVR or surgery in decompensated AS. Purpose The aim of this systematic review and meta-analysis is to assess 30-days mortality post-TAVR in patients submitted to an urgent procedure and compare them with the elective TAVR population. Methods We systematically searched three major databases (Medline, Cochrane Central Register of Controlled Trials and Scopus) for studies comparing patients submitted to urgent versus elective TAVR. Primary endpoint of our systematic review and meta-analysis is the 30-days mortality post-procedurally. Only studies provided data about our primary endpoint were considered in this analysis. Secondary endpoints comprised acute kidney injury (AKI), permanent pacemaker implantation (PPM) and stroke during the first 30-days post-TAVR. Risk ratio (RR) was calculated with 95% confidence intervals (CIs) and a random-effects model (Mantel-Haenzel) was used to estimate the pooled RR. Results This systematic review acquired 497 results. After duplicates removal, we screened 454 reports and we read full-text articles of 35 studies. Fourteen studies were included in our analysis. A total of 43,051 patients undergoing TAVR were included in our analysis; 3,607 patients submitted to an urgent TAVR, while the rest 39,444 had an elective procedure. Our analysis showed that patients undergoing urgent TAVR have 244% higher risk for mortality during the first 30-days post-procedurally (RR: 2.44, 95%CI: 1.49, 3.99) (Figure). Data about AKI, PPM and stroke during the first 30-days post-TAVR were available for 10 studies. The risk for AKI appeared to be significantly higher in patients undergone urgent TAVR (RR: 2.68, 95% CI: 1.60, 4.47). No significant differences were observed in stroke incidence (RR: 1.04, 95% CI: 0.89, 1.20) and PPM (RR: 1.08, 95%CI: 0.95, 1.22) during 30-days follow-up. Conclusion Compared to elective procedures, urgent TAVR seems to have increased 30-days mortality and AKI, and comparable PPM and stroke rates. These findings provide valuable insights offering potential updates to current guidelines in this field. Further studies on long-term outcomes and in a larger patient population are needed.

Association of urgent transcatheter aortic valve replacement (TAVR) with acute kidney injury 30-days post-TAVR: a systematic review and meta-analysis

Abstract Funding Acknowledgements None. Introduction Recent studies have proven that TAVR is a viable treatment option for symptomatic aortic stenosis (AS), regardless of surgical risk, even though, there are certain significant hazards associated with it. Even with the improvements in technique and experience, peri- and post-procedural complications like acute kidney injury (AKI) continue to occur frequently and are recognized for their serious clinical implications in the setting of TAVR. The vast majority of TAVR procedures conducted across the US are elective procedures on patients who are hemodynamically stable. Nonetheless, published data, imply that urgent TAVR, despite higher mortality rates is a feasible option to treat decompensated severe aortic valve stenosis. Purpose The aim of this systematic review and meta-analysis is to assess AKI in patients 30-days after an urgent TAVR and compare them with the elective TAVR population. Methods This meta-analysis adhered to the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). A comprehensive database search was conducted using three major databases (Medline, Cochrane Central Register of Controlled Trials and Scopus) for studies comparing patients submitted to urgent versus elective TAVR. Primary endpoint of our systematic review and meta-analysis is the AKI 30-days after TAVR. Only studies provided data about our primary endpoint were considered in the analysis. Secondary endpoints included myocardial infarction (MI), permanent pacemaker implantation (PPM) and bleeding events during the first 30-days post-procedurally. Risk ratio (RR) was calculated with 95% confidence intervals (CIs) and a random-effects model (Mantel-Haenzel) was used to estimate the pooled RR. Results A total of 16 studies with 101,568 patients were added in our analysis. Among them, 16,349 patients underwent an urgent TAVR, while the rest 85,219 had an elective procedure. Our analysis showed that patients submitted to urgent TAVR have 258% higher risk for AKI during the first 30-days post-procedurally (RR: 2.58, 95%CI: 1.98, 3.37) (Figure). Data about the 30-days MI, PPM and bleeding events were available for 9, 15 and 11 studies, respectively. The risk for MI appeared to be significantly higher in patients undergone urgent TAVR (RR: 5.49, 95% CI: 1.76, 17.05), while the risk for bleeding events was slightly higher in the same group (RR: 1.39, 95% CI: 1.14, 1.70). No significant differences were observed in PPM incidence (RR: 1.05, 95%CI: 1.00, 1.11) during 30-days follow-up. Conclusion In this systematic review and meta-analysis, patients undergoing urgent TAVR procedures compared to elective procedures have increased risk for AKI during the first 30-days post-TAVR. Thus, when urgent TAVR is performed risk factors for AKI should be evaluated and proper renal protection measures, such as adequate hydration and minimal contrast agent administration, should be implemented. Further research in this area is warranted.

TAVI in younger patients: is it a reliable option?

Abstract Funding Acknowledgements None. Background/Introduction Severe aortic stenosis is the most common valve disease requiring intervention. It has very poor prognosis, and early intervention is recommended. Either surgical or percutaneous transcatheter intervention is possible. According to European guidelines, surgical aortic valve replacement (SAVR) is usually indicated for patients younger than 75 years old. However, some patients are refused surgery, and transcatheter aortic valve implantation (TAVI) might be an option of treatment for these patients, however medium-long term results are still uncertain. Purpose This study intends to evaluate the efficacy and safety of TAVI in younger patients with severe symptomatic aortic stenosis. Methods Retrospective cohort of 224 patients were submitted to TAVI in the last 3 years, of which 21 patients were younger than 75 years old. The primary endpoints are mortality, major adverse cardiovascular events (MACE) and rehospitalization (related to the procedure, valve, or heart failure). Efficacy and safety were evaluated during a follow-up of at least 6 months, compared with the traditional group. Results A total of 224 patients underwent TAVI during the last 3 years at our center. Of these, 21 patients (9%) were younger than 75 years. The mean age was 72,1±3 [62-75] years old and 33% were female (n=7). 95% (n=20) of the TAVI procedures were due to degenerative severe aortic stenosis and 5% (n=1) due to degenerative aortic surgical valve prothesis. The mean euroscore risk value was 6,2±1,3%, and 18 patients were refused for surgery (86%) and 3 patients refused surgery (14%). All procedures were performed by transfemoral access, with 2 peripheral access complications (9,5%), 1 hemorrhagic (4%), solved with covered stent, and 1 closure device occlusion solved with wire crossing and balloon inflation (4%). It was necessary to implant 3 temporary pacemakers, however, only 2 patients required a definitive pacemaker implantation (9,5%). There were no cases intraprocedural death, MACE or aortic severe complications. There was a statistically significant reduction of risk of peripheral complications and pacemaker implantation on younger patients comparing with older patients (p=0,04 and p=0,05 respectively). Mean follow-up time was 14±8,3 months [6-39 months]. During follow-up there were no deaths, MACE or episodes of rehospitalization due to heart failure recorded. Regarding echocardiographic evaluation, there were no cases of significant valve degeneration, with mean aortic gradient of 13±4,1mmHg, no significant leakage or other echocardiographic findings. In younger patients, TAVI appears to be also valid therapeutic option, with less risk of peripheral access complication or need of permanent pacemaker implantation. During the follow-up there was no cases of prothesis degeneration, proving to be a reliable option for the medium to long term.

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.

Temporal Trends, Outcomes, and Predictors of Next-Day Discharge and Readmission Following Uncomplicated Evolut Transcatheter Aortic Valve Replacement: A Propensity Score-Matched Analysis.

Next-day discharge (NDD) outcomes following uncomplicated self-expanding transcatheter aortic valve replacement have not been studied. Here, we compare readmission rates and clinical outcomes in NDD versus non-NDD transcatheter aortic valve replacement with Evolut. Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry patients (n=29 597) undergoing elective transcatheter aortic valve replacement with self-expanding supra-annular valves (Evolut R, PRO, and PRO+) from July 2019 to June 2021 were stratified by postprocedure length of stay: ≤1 day (NDD) versus >1 day (non-NDD). Propensity score matching was used to compare risk adjusted 30-day readmission rates and 1-year outcomes in NDD versus non-NDD, and multivariable regression to determine predictors of NDD and readmission. Between the first and last calendar quarter, the rate of NDD increased from 45.4% to 62.1% and median length of stay decreased from 2 days to 1. Propensity score matching produced relatively well-matched NDD and non-NDD cohorts (n=10 549 each). After matching, NDD was associated with lower 30-day readmission rates (6.3% versus 8.4%; P<0.001) and 1-year adverse outcomes (death, 7.0% versus 9.3%; life threatening/major bleeding, 1.6% versus 3.4%; new permanent pacemaker implantation/implantable cardioverter-defibrillator, 3.6 versus 11.0%; [all P<0.001]). Predictors of NDD included non-Hispanic ethnicity, preexisting permanent pacemaker implantation/implantable cardioverter-defibrillator, and previous surgical aortic valve replacement. Most patients undergoing uncomplicated self-expanding Evolut transcatheter aortic valve replacement are discharged the next day. This study found that NDD can be predicted from baseline patient characteristics and was associated with favorable 30-day and 1-year outcomes, including low rates of permanent pacemaker implantation and readmission.

Mortality after cardiac resynchronization therapy or right ventricular pacing in transcatheter aortic valve replacement recipients.

Permanent pacemaker implantation (PMI) is associated with increased morbidity after transcatheter aortic valve replacement (TAVR). Cardiac resynchronization-therapy (CRT) is recommended for patients if left ventricular ejection fraction (LVEF) is ≤ 40% and ventricular pacing is expected in favor to sole right ventricular (RV) pacing. Meanwhile, LVEF may recover after TAVR in patients with aortic valve disease and the benefit of CRT is unknown. To analyze the impact of CRT implantation as compared to RV pacing after TAVR. Between 2012 and 2022, 4385 patients (53.1% female, mean age 81 ± 6years) without prior PMI undergoing TAVR were retrospectively identified in our institutional registry. After stratification of patients in LVEF ≤ 40%, 41-49% and ≥ 50%, Kaplan-Meier analysis revealed significantly different survival rates in each subgroup at 5years (37.0% vs. 43.5% vs. 55.1%; P ≤ 0.021). At multivariate regression, LVEF and new PMI after TAVR were not relevant for survival. A total of 105 patients with LVEF ≤ 40% received PMI after TAVR (86 patients with RV pacing and 19 with CRT). At 5years, all-cause mortality was significantly lower in patients with CRT-device as compared to patients without CRT-device (Kaplan Meier estimate of 21.1% vs. 48.8%; HR 0.48, CI 0.204 - 1.128; log rank p = 0.045). In multivariate analysis CRT remained a significant factor for 5-year survival in these patients (HR 0.3, CI 0.095-0.951, p = 0.041). In patients undergoing TAVR, PMI did not influence 5-year survival. In patients with LVEF ≤ 40%, CRT-device implantation was associated with improved survival compared to non-CRT-device implantation.

Resultados de un servicio ininterrumpido de implante urgente de marcapasos permanente

Introduction and objectives: Most of the complications associated with acute and symptomatic bradyarrhythmia (ASB) occur in the time from diagnosis to permanent pacemaker implantation (PPI). We aimed to evaluate the outcomes of an urgent 24/7 PPI service (PPI-24/7) for patients with ASB.Methods: A total of 664 patients undergoing first-time PPI for ASB were prospectively assessed during 2 periods of identical length (18 months): 341 patients who underwent the procedure during working hours only (PPI-WH), and 323 patients who underwent the procedure after the implementation of the PPI-24/7 service. The primary safety endpoint was established as the cumulative 180-day incidence of complications related to the index arrhythmia and device implant. The primary efficacy endpoint was determined as the average number of hospital stays per patient.Results: The PPI-24/7 period was associated with a significant shortening of the time from diagnosis to implantation (median [interquartile range]): 3 hours [2-6] vs 16 [5-21]). The cumulative incidence of patients with complications at 180 days was lower in the PPI-24/7 period: 9% vs 17% (adjusted odds ratio, 0.5; P = .002), due to a significant reduction in preimplant complications: 2.5% vs 12% (P < .001). The average number of hospital stays was reduced by 2 per patient in the PPI-24/7 period (nonparametric P < .001). PPI-24/7 implantes performed outside working hours (n = 178) were safe, with a 180-day cumulative incidence in procedure-related complications of 3.9%.Conclusions: Among patients with ASB, PPI-24/7 was associated with a significant reduction in patient morbidity and efficient hospital resource use.

Angiotensin-Converting Enzyme Inhibitors or Angiotensin Receptor Blockers After Transcatheter Aortic Valve Replacement: A Meta-Analysis

BackgroundPersistent left ventricular hypertrophy after transcatheter aortic valve replacement (TAVR) has been associated with poor outcomes. Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), due to their favorable effects on ventricular remodeling, have been hypothesized to improve outcomes post-TAVR, yet there are no recommendations regarding their use. ObjectivesThis study aimed to compare the outcomes of patients receiving ACEIs/ARBs with those not receiving ACEIs/ARBs after TAVR. MethodsWe performed a literature search on PubMed and Cochrane Library until June 14, 2023, and included all studies comparing clinical outcomes between patients given ACEIs/ARBs and those not given ACEIs/ARBs after TAVR. All-cause mortality was the primary outcome. We used a random effects model with appropriate corrections to calculate relative risk (RR) and CIs, with all analyses carried out using R v4.0.3. ResultsWe included ten studies on the use of ACEIs/ARBs post-TAVR. Patients on ACEIs/ARBs had lower risk of all-cause mortality (RR: 0.74, 95% CI: 0.65-0.86, I2 = 62%, chi-square P < 0.01), cardiovascular mortality (RR: 0.70, 95% CI: 0.56-0.88, I2 = 0%, chi-square P = 0.54), and new-onset atrial fibrillation (RR: 0.71, 95% CI: 0.52-0.96, I2 = 0%, chi-square P = 0.59). Patients on ACEIs/ARBs had a similar risk of myocardial infarction, heart failure, stroke, new permanent pacemaker implantation, acute kidney injury, major bleeding, vascular complications, aortic regurgitation, and mitral regurgitation. ConclusionsWe found that patients receiving ACEIs/ARBs had a lower risk of all-cause mortality, cardiovascular mortality, and new-onset atrial fibrillation. Risk of other outcomes was similar to patients not receiving ACEIs/ARBs. Randomized clinical trials are needed to explore the benefits of ACEIs/ARBs post-TAVR, so that definitive guidelines can be developed.

Comparisons of noncoronary sinus pivot implantation (NCPI) and conventional method for transcatheter aortic valve replacement with self-expanding valve in pure aortic regurgitation (PAR).

As compared to treatment of aortic stenosis (AS), transcatheter aortic valve replacement (TAVR) using the commercially available valves to treat pure aortic regurgitation (PAR) has a lower device success rate and higher complication rates. The study compared the acute results between TAVR using a novel noncoronary sinus pivot implantation (NCPI) method and that using the conventional method, aiming to explore a more optimized and effective operation method for TAVR in PAR. PAR patients who underwent TAVR with self-expanding valves in our center from September 2021 to September 2023 were enrolledwere divided into the NCPI (group A, N = 16) and conventional method (group B, N = 39) groups. We analyzed the pre-operative evaluation parametersand procedural and postoperative dataof the two subgroups. The total patients' mean age was 71.2 ± 8.7 years and most were male (61.8%), with a mean Society of Thoracic Surgeons score of 3.4 ± 1.9%. The device success rate of groups A and B was 100% and 71.8%, respectively. In group B, 48.7% had major adverse cardiac events (MACE); 46.2% patients had permanent pacemaker implantation or valve in valve implantation. None had MACE in group A. The noncoronary sinus implantation depth in NCPI was -1.7 + 1.0and 5.2 + 6.7 mm in groups A and B (p < 0.001), respectively. TAVR with a self-expanding valve using the NCPI method had a higher procedure success rate and dramatically low complications than that using the conventional method in PAR patients.

Comparison of Down Sizing Strategy (HANGZHOU Solution) and Standard Annulus Sizing Strategy in type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement: Rationale and design of a randomized clinical trial

BackgroundThere has not been a consensus on the prothesis sizing strategy in type 0 bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR). Modifications to standard annular sizing strategies might be required due to the distinct anatomical characteristics. We have devised a Down Sizing Strategy for TAVR using a self-expanding valve specifically for patients with type 0 bicuspid AS. The primary aim of this study is to compare the safety and efficacy of Down Sizing Strategy with the Standard Annulus Sizing Strategy in TAVR for patients with type 0 bicuspid AS. Trial designIt is a prospective, multi-center, superiority, single-blinded, randomized controlled trial comparing the Down Sizing and Standard Annulus Sizing Strategy in patients with type 0 bicuspid aortic stenosis undergoing transcatheter aortic valve replacement. Eligible participants will include patients with severe type 0 bicuspid AS, as defined by criteria such as mean gradient across aortic valve ≥40 mmHg, peak aortic jet velocity ≥4.0 m/s, aortic valve area (AVA) ≤1.0 cm², or AVA index ≤0.6 cm2/m2. These patients will be randomly assigned, in a 1:1 ratio, to either the Down Sizing Strategy group or the Standard Sizing Strategy group. In the Down Sizing Strategy group, a valve one size smaller will be implanted if the “waist sign” manifests along with less than mild regurgitation during balloon pre-dilatation. The primary end point of the study is a composite of VARC-3 defined device success, absence of both permanent pacemaker implantation due to high-degree atrioventricular block and new-onset complete left bundle branch block. ConclusionThis study will compare the safety and efficacy of Down Sizing Strategy with the Standard Annulus Sizing Strategy and provide valuable insights into the optimal approach for sizing in TAVR patients with type 0 bicuspid AS. We hypothesize that the Down Sizing Strategy will demonstrate superiority when compared to the Standard Annulus Sizing Strategy. (Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0) (TAILOR-TAVR), NCT05511792)

E-46 | Rates of Permanent Pacemaker Implantation Post-TAVR Using a Strategy of TEE and Non-Contrast CT in CKD Patients versus CT Angiography for Annular Sizing

E-46 | Rates of Permanent Pacemaker Implantation Post-TAVR Using a Strategy of TEE and Non-Contrast CT in CKD Patients versus CT Angiography for Annular Sizing

Transcatheter Aortic Valve Replacement in Low-Surgical Risk Patients: an updated metanalysis of extended follow-up randomized controlled trials.

The long-term safety and effectiveness of transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement (SAVR) in low surgical risk has not been evaluated in a pooled analysis. An electronic database search was conducted for randomized controlled trials (RCTs) with a maximal 5 years clinical and echocardiographic follow-up including low surgical risk patients underwent TAVR or SAVR. We calculated Odds Ratio (OD) and 95% confidence intervals (CIs) using a random-effects model. Subgroups analysis was performed for PPI and PVLs. Three randomized controlled trials (RCTs) were included with a total of 2611 low-surgical risk patients (STS score < 4%). Compared to SAVR, TAVR group had similar rates of all-cause of mortality (OR 0.94,95%CI 0.65 to 1.37, p value 0.75) and disabling stroke (OR 0.84, 95%CI 0.52 to 1.36, p value 0.48). No significant differences were registered in the TAVR group in terms of major cardiovascular events (OR 0.96, 95%CI 0.67 to 1.38,value 0.83), myocardial infarction (OR 0.69, 95% CI 0.34 to 1.40, p value 0.31),valve thrombosis (OR 3.11, 95%CI 0.29 to 33.47, p value 0.35), endocarditis (OR 0.71,95%CI 0.35 to 1.48, p value 0.36), aortic valve reintervention (OR 0.93, 95%CI 0.52 to 1.66, p value 0.80), and rehospitalization (OR 0.80, 95%CI 0.52 to 1.02, p value 0.07) compared to SAVR. However, TAVR patients had a higher risk of paravalvular leaks (OR 8.21, 95%CI 4.18 to 16.14, p value < 0.00001), but lower rates of new-onset atrial fibrillation (OR 0.27,95%CI 0.17 to 0.30, p value <0.0001). The rates of permanent pacemaker implantation were comparable from 1 year up to a maximum of 5 years (OR 1.32, 95%CI 0.88 to 1.97, p value 0.18). Lastly, TAVR had a greater effective orifice area (0.10 cm2/m2, 95%CI 0.05 to 0.15, p value 0.0001), but similar transvalvular mean gradients (0.60, 95%CI 3.94 to 2.73, p value 0.72). In conclusion, TAVR patients had similar long-term outcomes compared to SAVR, except for an elevated risk of PVLs in the TAVR group and increased rates of atrial fibrillation in the SAVR cohort.

Changes in hemodynamic parameters and atrial fibrillation risk in patients after permanent pacemaker implantation

Data on the development of left ventricular dysfunction after permanent pacemaker implantation are available. According to data from the DAVID (The Dual Chamber and VVI Implantable Defibrillator) study, it was shown that DDDR-paced patients had significantly more fatal events and HF deterioration cases requiring hospitalization. Similar were the results of the MOde Selection Trial (MOST), which poses serious questions to the cardiology community. For that reason it is important to understand how PPM implantation changes the hemodynamic parameters of the heart and what consequences this may have. On the one hand, asynchronous contraction of the paced heart and increase in AF risk with advancing age require active screening of asymptomatic paroxysms of tachyarrhythmias to promptly adjust therapy. On the other hand, minimizing the rate of ventricular pacing through proper programming of the devices should not be overlooked. Recently, various biomarkers have been validated to select high-risk patients in which the therapeutic strategy can be modulated on time.

AV-optimized conduction system pacing for treatment of AV dromotropathy: A randomized, cross-over study.

Severe first-degree atrioventricular (AV) block may produce symptoms similar to heart failure due to AV dyssynchrony, a syndrome termed AV dromotropathy. According to guidelines, it should be considered for permanent pacemaker implantation, yet evidence supporting this treatment is scarce. This study aimed to determine the impact of AV-optimized conduction system pacing (CSP) in patients with symptomatic severe first-degree AV block and echocardiographic signs of AV dyssynchrony. Patients with symptomatic first-degree AV block (PR > 250 ms), preserved left ventricular ejection fraction, narrow QRS, and AV dyssynchrony were included in the study. In a single-blind cross-over design, patients were randomized to AV sequential CSP or backup VVI pacing with a base rate of 40 bpm. We compared exercise capacity, echocardiographic parameters, and symptom occurrence at the end of 3 months of each period. Fourteen patients completed the study. During the AV-optimized CSP compared to the backup pacing period, patients achieved a higher workload on exercise test (147.2 ± 50.9 vs. 140.7 ± 55.8 W; p = .032), with a trend towards higher peak VO2 (23.3 ± 7.1 vs. 22.8 ± 7.1 mL/min/kg; p = .224), and higher left ventricular stroke volume (LVSV 74.5 ± 13.8 vs. 66.4 ± 12.5 mL; p < .001). Symptomatic improvement was recorded, with fewer patients reporting general tiredness and 71% of patients preferring the AV-optimized CSP (p = .008). AV-optimized CSP could improve symptoms, exercise capacity and LVSV in patients with severe first-degree AV block.

Three-year incidence of pacemaker implantation in patients with atrial fibrillation and sinus node dysfunction receiving ablation versus antiarrhythmic drugs.

Sinus node dysfunction (SND) is commonly seen in patients with atrial fibrillation (AF). The purpose of this study was to compare the incidence of pacemaker implantation among patients with SND and AF treated with catheter ablation (CA) versus anti-arrhythmic drugs (AADs). The 2013-2022 Optum Clinformatics database, an administrative claims database for commercially insured individuals in the United States (US), was used for this study. Patients with AF and SND and a history of at least one AAD prescription were identified and classified into CA or AAD cohorts based on subsequent treatment received. Inverse probability treatment weighting was applied to balance socio-demographic and clinical characteristics between the cohorts. Weighted Cox regression modeling was used to evaluate the differential risk of incident permanent pacemaker (PPM) implantation. Sub-analyses were performed by AF type (paroxysmal versus persistent). A total of 1206 patients in the AAD cohort and 1624 patients in the CA cohort were included. Study cohorts were well-balanced post-weighting. The incidence rate of PPM implantation (per 1000 person-year) was 55.8 for the CA cohort and 117.8 for the AAD cohort. Regression analysis demonstrated that the CA cohort had 42% lower risk of incident PPM implantation than those treated with AADs (hazard ratio [HR], 0.58; 95% CI, 0.46-0.72, p < 0.001). CA-treated patients had lower risks of PPM implantation versus AAD-treated patients among those with paroxysmal AF (HR, 0.48; 95% CI, 0.34-0.69, p < 0.001) and persistent AF (HR, 0.57; 95% CI, 0.40-0.81, p = 0.002). Patients with AF and SND treated with CA have significantly lower risks of incident PPM implantation compared with those treated with an AAD.

Mortality Rates in Patients Undergoing Urgent Versus Elective Transcatheter Aortic Valve Replacement: A Meta-analysis.

Patients with severe aortic stenosis (AoS) often present with acute heart failure and compensation, frequently leading to cardiogenic shock. Transcatheter Aortic Valve Replacement (TAVR) has been recently performed as a bailout treatment in such patients. The aim of our meta-analysis is to compare urgent TAVR with elective procedures. We systematically screened three databases searching for studies comparing urgent vs elective TAVR. Primary endpoint is the 30-days mortality. Secondary endpoints included in-hospital mortality, device success, periprocedural vascular complications, 30-days stroke, 30-days acute kidney injury (AKI), permanent pacemaker implantation (PPM), moderate or severe paravalvular leakage, and 30-days bleeding. Seventeen studies were included, with a total of 84,495 patients. Urgent TAVR was associated with an increased risk for 30-days mortality [Risk Ratio (RR): 2.53, 95% Confidence Intervals (CI): 1.81-3.54)], in-hospital mortality (RR: 2.67, 95% CI: 1.94-3.68), periprocedural vascular complications (RR: 1.91, 95% CI: 1.28-2.85) and AKI (RR: 2.83, 95% CI: 1.93-4.14), compared with elective procedure. No differences were observed in the other secondary endpoints. Urgent TAVR was associated with higher in-hospital and 30-days mortality, possibly driven by the increased incidence of AKI and vascular complications in urgent TAVR. The results highlight the importance of early TAVR in stable AoS patients.

Incidence of Pocket Infection after Implantation of Permanent Pacemaker

Objective: The research aimed to enhance clinical awareness and optimise preventive strategies in permanent pacemaker (PPM) implantation&#x0D; Methodology: We followed the patient on 2nd and 4th weeks after implantation of PPM. A total of 500 patients were followed over a 1-year period of time. We defined pocket PPM infection as the presence of local oedema and redness or swelling with and without systemic signs of infection that required antibiotic therapy and/or device removal.&#x0D; Results: The mean age of the patients was 55.4 ± 14.2 years, and 58% were male. The most common indications for PPM implantation were atrioventricular block (42%), sick sinus syndrome (32%), and atrial fibrillation with slow ventricular response (18%). The median follow-up time was 12 months. The overall incidence of PPM infection was 2.4% (12 cases).&#x0D; Conclusion: PPM pocket infection is a rare but serious complication that occurs mainly within the 2 weeks after implantation. Diabetes mellitus, renal failure, and the use of temporary pacing wires are significant risk factors for PPM infection. Prevention strategies and close follow-up are essential to reduce the morbidity and mortality associated with this complication.