Postoperative Permanent Pacemaker Implantation Research Articles

Predictors for new-onset conduction block in patients with pure native aortic regurgitation after transcatheter aortic valve replacement with a new-generation self-expanding valve (VitaFlow Liberty™): a retrospective cohort study

BackgroundNew-generation self-expanding valves can improve the success rate of transcatheter aortic valve replacement (TAVR) for severe pure native aortic regurgitation (PNAR). However, predictors of new-onset conduction block post-TAVR using new-generation self-expanding valves in patients with PNAR remain to be established. Therefore, this study aimed to identify predictors of new-onset conduction block post-TAVR using new-generation self-expanding valves (VitaFlow Liberty™) in patients with PNAR.MethodsIn this retrospective cohort study, patients were categorized into pacemaker and non-pacemaker groups based on their need for new postoperative permanent pacemaker implantation (PPI). Based on the postoperative presence of either new-onset complete left bundle branch block (cLBBB) or high-grade atrioventricular block (AVB), patients were further classified into conduction disorder and non-conduction disorder groups. Laboratory, echocardiographic, computed tomography, preoperative and postoperative electrocardiography, and procedural and clinical data were collected immediately after TAVR and during hospitalization and compared between the groups. Multivariate logistic regression analysis was performed incorporating the significant variables from the univariate analyses.ResultsThis study examined 68 consecutive patients with severe PNAR who underwent TAVR. In 20 patients, a permanent pacemaker was fitted postoperatively. Multivariate logistic regression analysis revealed an association between the need for postoperative PPI and preoperative complete right bundle branch block (cRBBB) or first-degree AVB, as well as a non-tubular left ventricular outflow tract (LVOT). In addition, valve implantation depth and angle of aortic root were independent predictors of new-onset cLBBB or high-grade AVB developing post-TAVR. The predictive value of valve implantation depth and angle of aortic root was further supported by receiver operating characteristic curve analysis results.ConclusionsIn patients with PNAR undergoing TAVR using self-expanding valves, preoperative cRBBB or first-degree AVB and a non-tubular LVOT were indicators of a higher likelihood of PPI requirement. Moreover, deeper valve implantation depth and greater angle of aortic root may be independent risk factors for new-onset cLBBB or high-grade AVB post-TAVR. Valve implantation depth and angle of aortic root values may be used to predict the possibility of new cLBBB or high-grade AVB post-TAVR.

Novel Aortic Valve Replacement Technique for Reducing Complete Heart Block.

Aortic valve replacement (AVR) may complicate conduction abnormalities and require permanent pacemaker (PPM) implantation. New techniques that lessen this challenge may lead to the development of new approaches. Our objective was to evaluate the contemporary incidence of early postoperative PPM implantation in patients undergoing isolated AVR and root disease with the standard AVR surgical technique compared with the novel suture AVR technique. The clinical data of 354 patients (250 male, 104 female) who underwent surgery for isolated AVR and root disease in different referral cardiology departments in Tabriz, Iran, over 4 years were analyzed. Patients with preoperative significant conduction abnormalities were excluded from the study. The patients were evaluated for in-hospital mortality, postoperative PPM implantation, and their stay in the ICU after surgery. The mean age of the patients was 52.46±16.13 years. Totally, 183 patients (51.7%) were operated on with the new suture AVR technique. In-hospital mortality was lower in this group than in the group that underwent the "classic" surgical technique (2.5% vs 3.7%). PPM implantation was required in 3 patients (0.8%) after the novel suture AVR technique, whereas it was needed in 12 patients (3.4%) in the other group (P=0.024). The mortality rate was 9 patients (2.5%) in group 1 and 13 patients (3.7%) in group 2, which was not statistically significant (P=0.296). According to the logistic regression, the survival rate in the group operated on with the classical surgical method was 0.27 times higher than that in the patients operated on with the new method. Permanent complete AV block is a critical complication after AVR surgery. A lower PPM requirement and higher survival in patients operated on with the new method was the main finding of this study. New techniques with lower PPM requirements may be suitable for cardiac surgery.

Abstract 17195: Sex-Specific Differences in Outcomes Following Alcohol Septal Ablation or Septal Myectomy for Hypertrophic Obstructive Cardiomyopathy: A Systematic Review and Meta-Analysis

Introduction: Clinical evidence and emerging studies suggest that the clinical heterogeneity observed in hypertrophic obstructive cardiomyopathy (HOCM) could be due to sex-based differences. However, definite evidence to guide sex-specific treatment is not yet available. We aim to explore the sex-related differences in treatment outcomes following alcohol septal ablation (ASA) and septal myectomy (SM). Methods: We searched PUBMED/MEDLINE, EMBASE, and SCOPUS to identify studies that report sex-stratified comparison of outcomes in adults undergoing ASA or SM. The primary outcomes were the short-term/ 30-day mortality, post-operative permanent pacemaker (PPM) requirement, and the length of in-hospital stay. Results: Fifteen studies totaling 31,907 patients (47% men and 53% women) met our eligibility criteria. Among patients undergoing ASA (n=13357) or SM (n=18550), females were found to be significantly older at the time of intervention (ASA - mean difference (MD): 7.55 years; 95% CI [4.83, 10.28]; p < 0.00001; SM - MD: 4.41; 95% CI [2.79, 6.03]; p < 0.00001).In both the ASA and SM treatment arms, females had a significantly higher risk of short-term all-cause mortality (ASA - RR: 0.48, 95% CI [0.32, 0.71]; p = 0.0003; SM - RR: 0.63; 95% CI [0.44, 0.90]; p = 0.01), greater PPM implantation rate (ASA - p = 0.002; SM - p = 0.05), and longer in-hospital stay (ASA - MD: 1.00 days; p < 0.00001; SM - MD: 0.69; p < 0.00001). Among those undergoing ASA, females had a significantly higher rate of atrioventricular (AV) block (p < 0.00001). However, the 30-day re-admission rate following SM was similar in both sexes. Conclusions: This is the first meta-analysis to compare sex differences in HOCM treatment outcomes. Female patients were older, had higher short-term mortality, and required more PPM implants compared to males, regardless of whether they received ASA or SM. This emphasizes the critical need for a sex-specific treatment approach in managing HOCM.

Cost of Pacing in Pediatric Patients With Postoperative Heart Block After Congenital Heart Surgery

Surgical correction of congenital heart defects (CHDs) has improved the lifespan and quality of life of pediatric patients. The number of congenital heart surgeries (CHSs) in children has grown continuously since the 1960s. This growth has been accompanied by a rise in the incidence of postoperative heart block requiring permanent pacemaker (PPM) implantation. To assess the trends in permanent pacing after CHS and estimate the economic burden to patients and their families after PPM implantation. In this economic evaluation study, procedure- and diagnosis-specific codes within a single-institution database were used to identify patients with postoperative heart block after CHS between January 1, 1960, and December 31, 2018. Patients younger than 4 years with postoperative PPM implantation were selected, and up to 20-year follow-up data were used for cost analysis based on mean hospital event charges and length of stay (LOS) data. Data were analyzed from January 1, 2020, to November 30, 2022. Implantation of PPM after CHS in pediatric patients. Annual trends in CHS and postoperative PPM implantations were assessed. Direct and indirect costs associated with managing conduction health for the 20 years after PPM implantation were estimated using Markov model simulation and patient follow-up data. Of the 28 225 patients who underwent CHS, 968 (437 female [45.1%] and 531 male [54.9%]; 468 patients aged <4 years) received a PPM due to postoperative heart block. The rate of CHS and postoperative PPM implantations increased by 2.2% and 7.2% per year between 1960 and 2018, respectively. In pediatric patients younger than 4 years with PPM implantation, the mean (SD) 20-year estimated direct and indirect costs from Markov model simulations were $180 664 ($32 662) and $15 939 ($1916), respectively. Using follow-up data of selected patients with clinical courses involving 1 or more complication events, the mean (SD) direct and indirect costs were $472 774 ($212 095) and $36 429 ($16 706), respectively. In this economic evaluation study, the cost of PPM implantation in pediatric patients was found to accumulate over the lifespan. This cost may represent not only a substantial financial burden but also a health care burden to patient families. Reducing the incidence of PPM implantation should be a focused goal of CHS.

Extrathoracic Against Intrathoracic Vascular Accesses for Transcatheter Aortic Valve Replacement: A Systematic Review With Meta-Analysis

Alternative vascular accesses to transfemoral access for transcatheter aortic valve replacement (TAVR) can be divided into intrathoracic (IT)-transapical and transaortic- and extrathoracic (ET)-transcarotid, transsubclavian, and transaxillary. This study aimed to compare the outcomes and safety of IT and ET accesses for TAVR as alternatives to transfemoral access. A systematic review with meta-analysis was performed by searching PubMed/MEDLINE and EMBASE databases for all studies comparing IT-TAVR with ET-TAVR published until April 2023. Outcomes included in-hospital or 30-day all-cause mortality (ACM), 1-year ACM, postoperative and 30-day complications. A total of 18 studies with 6,800 IT-TAVR patients and 5,032 ET-TAVR patients were included. IT accesses were associated with a significantly higher risk of in-hospital or 30-day ACM (relative risk 1.99, 95% confidence interval 1.67 to 2.36, p <0.001), and 1-year ACM (relative risk 1.31, 95% confidence interval 1.21 to 1.42, p <0.001). IT-TAVR patients presented more often with postoperative life-threatening bleeding, 30-day new-onset atrial fibrillation or flutter, and 30-day acute kidney injury needing renal replacement therapy. The risks of postoperative permanent pacemaker implantation and significant paravalvular leak were lower with IT-TAVR. ET-TAVR patients were more likely to be directly discharged home. There was no statistically significant difference regarding the 30-day risk of stroke. Compared with ET-TAVR, IT-TAVR was associated with higher risks of in-hospital or 30-day ACM, 1-year ACM and higher risks for some critical postprocedural and 30-day complications. Our results suggest that ET-TAVR could be considered as the first-choice alternative approach when transfemoral access is contraindicated.

Sutureless and Rapid Deployment vs. Transcatheter Valves for Aortic Stenosis in Low-Risk Patients: Mid-Term Results.

Recent trials showed that TAVI is neither inferior nor superior to surgical aortic valve replacement. The aim of this study was to evaluate the outcomes of Sutureless and Rapid Deployment Valves (SuRD-AVR) when compared to TAVI in low surgical risk patients with isolated aortic stenosis. Data from five European Centers were retrospectively collected. We included 1306 consecutive patients at low surgical risk (EUROSCORE II < 4) who underwent aortic valve replacement by means of SuRD-AVR (n = 636) or TAVI (n = 670) from 2014 to 2019. A 1:1 nearest-neighbor propensity-score was performed, and two balanced groups of 346 patients each were obtained. The primary endpoints of the study were: 30-day mortality and 5-year overall survival. The secondary endpoint was 5-year survival freedom from major adverse cardiovascular and cerebrovascular events (MACCEs). Thirty-day mortality was similar between the two groups (SuRD-AVR:1.7%, TAVI:2.0%, p = 0.779), while the TAVI group showed a significantly lower 5-year overall survival and survival freedom from MACCEs (5-year matched overall survival: SuRD-AVR: 78.5%, TAVI: 62.9%, p = 0.039; 5-year matched freedom from MACCEs: SuRD-AVR: 64.6%, TAVI: 48.7%, p = 0.004). The incidence of postoperative permanent pacemaker implantation (PPI) and paravalvular leak grade ≥ 2 (PVL) were higher in the TAVI group. Multivariate Cox Regression analysis identified PPI as an independent predictor for mortality. TAVI patients had a significantly lower five-year survival and survival freedom from MACCEs with a higher rate of PPI and PVL ≥ 2 when compared to SuRD-AVR.

Permanent pacemaker implantation after valve and arrhythmia surgery in patients with preoperative atrial fibrillation.

Among patients referred for cardiac surgery, atrial fibrillation (AF) is a common comorbidity and a risk factor for postoperative arrhythmias (eg, sinus node dysfunction, atrioventricular heart block), including those requiring permanent pacemaker (PPM) implantation. The purpose of this study was to evaluate the prevalence and long-term survival of postoperative PPM implantation in patients with preoperative AF who underwent valve surgery with or without concomitant procedures. Presented analysis pertains to the HEIST (HEart surgery In atrial fibrillation and Supraventricular Tachycardia) registry. During the study period, 11,949 patients underwent valvular (aortic, mitral, or tricuspid valve replacement or repair) surgery and/or surgical ablation (SA) and were stratified according to postoperative PPM status. PPM implantation after surgery was necessary in 2.5% of patients, with significant variation depending on the type of surgery (from 1.1% in mitral valve repair to 3.3% in combined mitral and tricuspid valve surgery). In a multivariate logistic regression model, tricuspid intervention (P <.001), cardiopulmonary bypass time (P = .024), and endocarditis (P = .014) were shown to be risk factors for PPM. Over long-term follow-up, PPM was not associated with increased mortality compared to no PPM (hazard ratio 0.96; 95% confidence interval 0.77-1.19; P = .679). SA was not associated with PPM implantation. However, SA improved survival regardless of PPM status (log rank P <.001). In patients with preoperative AF, the need for PPM implantation after valve surgery or SA is not an infrequent outcome, with SA not affecting its prevalence but actually improving long-term survival.

Incidence and predictors of permanent pacemaker implantation after surgical aortic v alve replacement: Data of the Netherlands Heart Registration (NHR).

ObjectivePermanent pacemaker implantation (PPI) after surgical aortic valve replacement (SAVR) remains a frequent complication. Predictors, however, have been mainly investigated in single‐center studies. Therefore, nationwide data were used to identify patients—and procedural risk factors for postoperative PPI.Materials and MethodsData were retrospectively collected from the Netherlands Heart Registration (NHR). Patients enrolled in the NHR undergoing isolated SAVR from 2013 to 2019 were analyzed. Primary endpoint was in‐hospital PPI during hospitalization after SAVR.ResultsFrom the NHR database, 5600 patients with symptomatic aortic valve stenosis were included in the study. Crude incidence of post‐SAVR PPI was 4.0%. Backward regression analysis identified previous cardiac surgery (odds ratio [OR]: 1.80; 95% confidence interval [CI]: 1.18–2.76), extra‐corporeal circulation time (OR: 1.01; 95% CI: 1.00–1.01), vasopressor use (OR: 2.66; 95% CI: 1.79–3.96) and in‐hospital cardiac conduction abnormalities (OR: 4.48; 95% CI: 3.36–5.98) as potential predictors for PPI. Across the time, PPI after SAVR significantly increased (OR: 1.11; 95% CI: 1.03–1.21).ConclusionsFrom this nationwide analysis, PPI after SAVR remains a low but increasingly frequent complication. Several predictive factors for postoperative PPI after SAVR have been identified and might be useful for patient informed consent about potential adverse event rate.

Effect of Permanent Pacemaker Implantation After Valve Surgery on Long-Term Outcomes.

Patients are prone to permanent pacemaker implantation (PPM) after valve surgery, yet current data on the effects of postoperative PPM are scarce and large-scale studies are lacking. The aim of this study was to determine rates and long-term outcomes of PPM after cardiac valve surgery.Methods and Results:A total of 24,014 patients who received valve surgery from 2000 to 2013 were identified from the Taiwan National Health Insurance Research Database. The number of valve surgeries and the proportion of PPM implantations after valve surgery increased (P<0.001). After 1 : 5 propensity score matching, 602 and 3,010 patients were categorized to the PPM and non-PPM groups, respectively. Late outcomes included all-cause mortality, cardiovascular death, sepsis, and readmission due to any cause. The mean follow up was 4.3 years. PPM was associated with a higher all-cause mortality rate (33.6% vs. 29.8%; hazard ratio [HR], 1.14; 95% confidence interval [CI], 0.98-1.32), though not significant at the threshold of P<0.05. PPM was also associated with higher all-cause mortality rates in subgroups that received mitral valve (MV) replacement surgery, combined aortic valve replacement (AVR) with MV surgeries, and combined AVR with tricuspid valve surgeries. The PPM rate after valve surgery is increasing, and is associated with short-term adverse effects. Patients with PPM may have a higher long-term mortality rate.

Perceval S valve empire: healing the Achilles' heel of sutureless aortic valves.

Aortic valve replacement is the treatment of choice concerning aortic valve disease. Excellent short- and long-term clinical results are reported. Patients referred for aortic valve replacement are getting older and older, so bioprosthetic valves play a more central role worldwide. However, patient comorbidities are also increased more often rendering patients unsuitable for open conventional aortic valve replacement. As a result, transcatheter aortic valve implantation has become the treatment of choice in patients at very high surgical risk. However, the percutaneous technique is related to major disadvantages provided that the diseased native valve is left in place. Its durability is also uncertain. More recently, sutureless Perceval S valve bioprosthesis has gained ground in the field of aortic stenosis therapy filling the gap between conventional aortic valve replacement and transcatheter approach. Excellent hemodynamic and clinical results are reported. Its deployment is performed under direct view and ischemic and overall operative times are significantly decreased. Five-year follow-up results are also optimal. However, the "Achilles' heel" of sutureless technology is increased rates of postoperative permanent pacemaker implantation requirement compared to conventional approach. The incidence of this complication varies in literature. Patient-related factors such as preoperative conduction disorders, older age and short membranous septum are predictors of postoperative pacemaker requirement. However, several technical modifications regarding manufacturer recommendations can be adopted to mitigate this complication. Appropriate annular decalcification, higher guiding sutures placement, reduced balloon pressure and duration and avoiding of oversizing can contribute to prevent from this complication.

Need for permanent pacemaker implantation following implantation of the rapid deployment valve in combined procedures: a single centre cohort study

BackgroundRapid deployment aortic valves may interfere with the cardiac conduction system. We investigated the need for permanent pacemaker implantation (PPI) following the implantation of Edwards INTUITY valve (Edwards Lifesciences, Irvine, CA).MethodsOne hundred twenty patients underwent aortic valve replacement (AVR) with the INTUITY valve in a combined procedure at the German Heart Centre Munich between April 2016 and December 2019. Twenty-four patients with prior PPI or concomitant ablation procedures (24/120, 20%) were excluded. Patient-specific, procedural and post-procedural outcomes were assessed in the remaining 96 cases.ResultsAVR was successful in all cases. Seventy-four percent of the study population were men. Mean age was 69.5±7.6 years. EuroSCORE II was 3.2±2.9. Forty-six patients (46/96, 47.9%) presented with pre-operative conduction disorders, right bundle branch block (RBBB) (17/96, 17.7%) and first-degree or second degree atrio-ventricular block (AVB) (18/96, 18.8%), in particular. In total, 9 patients (9/96, 9.4%) underwent PPI. PPI was required in 3 patients (3/50, 6.0%) who did not have a pre-existing conduction disorder due to new high degree AVB. 6 patients with pre-operative conduction disorders (6/46, 13%) needed PPI. Timing of PPI was 5.2±1.5 days (median 5). Independent predictors of PPI were preoperative RBBB [odds ratio (OR) =4.554, P=0.049] and large valve size (#27) (OR =5.527, P=0.031).ConclusionsThe analysis of the data collected enabled us to identify patient factors associated with higher risk for post-operative PPI following AVR with the INTUITY valve. Patient factors associated with post-operative PPI, were RBBB and large valve size. These patients should be closely monitored following the procedure, in particular.

Surgical septal myectomy outcome for obstructive hypertrophic cardiomyopathy after alcohol septal ablation.

BackgroundAlthough surgical treatment of residual obstruction after alcohol septal ablation (ASA) is often challenging in patients with obstructive hypertrophic cardiomyopathy (OHCM) there are very few relevant clinical reports. Thus, outcomes of surgical septal myectomy (SSM) in this subgroup of patients remain to be determined. Therefore, this study aimed to determine the surgical and follow-up outcomes in patients with OHCM exhibiting residual obstruction after ASA.MethodsWe collected case data for 62 patients with OHCM and residual obstruction after ASA who underwent SSM at Fuwai Hospital between January 2002 and June 2019. Propensity score matching with patients having had a myectomy as the only invasive procedure—was conducted in a 1:2 ratio. Echocardiography parameters, surgery results, and follow-up outcomes were compared between the groups.ResultsThe prior ASA group had a higher incidence of complete atrioventricular block (AVB) and subsequently postoperative permanent pacemaker (PPM) implantation than the primary myectomy group (9.7% vs. 1.6%, P=0.01). Two patients died within 30 days after surgery in the prior ASA group, and one patient died in the primary myectomy group, with an operative mortality rate of 3.2% and 0.8%, respectively (P=0.2). The 5-year event-free survival rate was 86.0% in the prior ASA group (median follow-up period: 3.2 years; mean: 3.9±2.6 years; maximum, 10.6 years) and 88.5% in the primary myectomy group (median follow-up period: 2.4 years; mean 2.8±1.7 years; maximum, 9.1 years) (P=0.2). During follow-up, four of 62 (6.5%) patients in the prior ASA group and one of 124 (0.8%) patients in the primary myectomy group progressed to advanced heart failure (P=0.025).ConclusionsPatients with OHCM following ASA are at an increased risk of developing AVB after SSM. Their surgical outcomes, and long-term survival rate were satisfactory and, osimilar to those for patients having had a myectomy as the only invasive procedure. In addition, they had an increased risk of advanced heart failure after SSM in the present study.

Predictors of Pacemaker Insertion Post-Sutureless (Perceval) Aortic Valve Implantation

The use of rapid deployment sutureless aortic valve replacement (AVR) has become a viable alternative to conventional AVR especially in intermediate and high-risk patients. However, sutureless AVR has been associated with increased rates of permanent pacemaker (PPM) implantation compared with conventionally implanted aortic valve prostheses. The aim of this study was to determine predictive factors for complete heart block requiring insertion of a PPM post-AVR with a Perceval S sutureless valve (LivaNova, London, UK). Such knowledge will help to improve patient counselling, selection and management of patients undergoing sutureless AVR. A retrospective cohort study assessed all patients who underwent insertion of the Perceval sutureless aortic valve prosthesis between July 2015 and September 2019. Medical records were reviewed for demographic, preoperative electrocardiograph (ECG), and operative features related to postoperative PPM implantation and follow-up in the electrophysiology clinic. One hundred and thirty (130) patients without pre-existing PPM underwent sutureless AVR (66.9% male, average age 74.4±6.6 years). Fifty-seven (57) underwent concomitant cardiac surgical procedures. Eight (8) patients underwent redo cardiac surgery. Nineteen (19) of the 130 (14.6%) patients required insertion of a PPM during their postoperative course. Factors associated with PPM insertion were right bundle branch block (overall n=15, PPM vs No PPM: 8/19 vs 7/111 [42.1 % vs. 6.31 %; p<0.01]), longer QRS duration 113.32ms±22.24 ms vs 100.52±20.96 ms (p=0.017) and longer PR Interval 185.166±42.38 ms vs 169.23±25.70 ms (p=0.03). Insertion of rapid deployment sutureless aortic valves in the setting of pre-existing right bundle branch block, prolonged QRS complex and longer PR intervals is associated with increased risk of postoperative PPM requirement. These factors should be considered when preoperatively counselling and postoperatively managing patients when balloon expandable sutureless valves are used.

Biatrial ablation vs. Pulmonary vein isolation in atrial fibrillation patients undergoing cardiac surgery: a retrospective study

Objectives Surgical ablation is an established treatment for patients with atrial fibrillation undergoing cardiac surgery. This study aimed to compare postoperative rhythm outcomes and pacemaker implantation rates after biatrial ablation or pulmonary vein isolation (PVI) concomitantly with other cardiac surgery. Design: In a retrospective study, we included patients who underwent biatrial ablation or PVI. Postoperative rhythm status was assessed by Holter monitoring. All data on outcomes and patient characteristics were collected retrospectively. Results: In total 109 patients had a biatrial procedure whereas 337 had PVI performed. In patients with persistent/long-standing persistent atrial fibrillation, freedom from atrial fibrillation was more common after biatrial ablation than after PVI (63% and 45%, respectively; p = .039). Postoperative permanent pacemaker implantation was more common after biatrial ablation (12% and 6%, respectively; p = .039), compared to PVI. Age < 65 years (OR:2.0, 95% CI:1.1–3.6) was a predictor of freedom from atrial fibrillation in the biatrial group, whereas absence of left atrial dilatation (OR:1.8, 95% CI:1.1–3.2) and HAS-BLED score < 2 (OR:1.9, 95% CI:1.0–3.8) were significant predictors of freedom from atrial fibrillation in the PVI group. Conclusions: In patients with persistent/long-standing persistent atrial fibrillation, biatrial ablation is more effective than PVI in terms of obtaining freedom from postoperative atrial fibrillation. Although our groups were heterogenic in terms of concomitant surgery, our study also indicates that the risk of needing a permanent pacemaker is higher after biatrial ablation, compared to PVI. Therefore, our study highlights that the decision between biatrial ablation or PVI should be performed on an individual basis.

Concomitant surgical ablation of atrial fibrillation: long-term outcomes

Abstract Introduction Atrial fibrillation (AF) is the most common cardiac related arrhythmia, independently associated with an increased risk of death and high level of morbidity, such as stroke, heart failure, as well as frequent hospitalization and reduced quality of life. Surgical ablation is an effective therapy for patients with AF undergoing concomitant cardiac surgery. Purpose In this study we report the results of concomitant surgical AF ablation, in terms of efficacy and safety, with a long-term follow-up at 10 years. Methods Two-hundred fourteen (214) consecutive patients (female, 45.17%) underwent from 1999 to 2016 surgical ablation of AF concomitantly with other major cardiac procedures. Mean age was 67.4±9.82. Patients had persistent and long-standing persistent AF in 64.65% of cases. Primary endpoints were overall survival, freedom from stroke and freedom from AF. Results Perioperative mortality was 2.3% (5/214). Mean EuroSCORE II was 5.2±4.4. Concomitant mitral valve surgery was performed in 56.74% of patients, 31% of patients had a concomitant aortic valve surgery, while myocardial revascularization either isolated or associated with aortic valve was performed in 11.63% and 3.72% of cases respectively. Ablation was carried out by means radio-frequency box lesions set in 35.51% (76/214) of patients while pulmonary veins isolation with bipolar clamp and Cox-MAZE IV was performed in 51.86% (111/214) and 12.61% (27/214) of patients respectively. Left atrial appendage (LAA) exclusion was performed in 57 patients (26.51%) after careful echocardiographic investigation of diastolic and atrial function. Incidence of early postoperative (30 days) permanent pacemaker implantation was as low as 2.3%. The mean follow-up was 6.71±4.47 years. The New York Heart Association functional class (2.84 vs. 1.91, p&amp;lt;0.001) and ejection fraction (54.4% vs. 56.6%, p&amp;lt;0.001) were improved compared with the preoperative status. At 10 years Kaplan-Meier overall survival was 62.3%. Freedom from cardiac related death was 98%, while freedom from stroke was 98% at 10 years. Efficacy endpoint showed a freedom from AF at 10 years, according to HRS criteria of 66.7%. Fisher exact test comparing mitral surgery patients or ischemic CABG-patients showed no differences in terms of stroke rate (p=0.999), while postoperatively, there was a higher rate of stroke at thirty days in patients with postoperative AF (p=0.019). Conclusions Concomitant surgical ablation of AF was associated with a very low incidence of postoperative PM implantation and provides excellent results in terms of stable rhythm outcome at long-term. Postoperative AF significantly increased the risk of stroke in the early postoperative period. Funding Acknowledgement Type of funding source: None

Short-term outcome of the intuity rapid deployment prosthesis: a systematic review and meta-analysis

Limited access aortic valve replacement is an alternative approach for the treatment of calcified aortic valve disease. To facilitate limited access aortic valve replacement, rapid deployment valve prostheses have been developed aiming to reduce surgical impact. This systematic review gives an overview of current literature regarding the INTUITY or INTUITY Elite rapid deployment biological valve prosthesis. Cochrane, Embase and MEDLINE were searched to identify relevant studies. All studies reporting on patients who underwent isolated or combined surgical aortic valve replacement with the INTUITY or INTUITY Elite valve prosthesis were considered eligible. Primary end points were technical success rate, 30-day mortality, cerebrovascular accident, paravalvular leak and permanent pacemaker implantation. Secondary end points included procedural data such as aortic cross-clamping time, cardiopulmonary bypass time and procedural approach. A total of 16 articles fulfilled the inclusion and exclusion criteria and comprised 4.184 patients. Thirty-day mortality was 2.7% (1.9-3.7%), cerebrovascular accident 2.6% (1.4-4.7%), permanent pacemaker implantation 7.9% (6.6-9.5%) and severe postoperative paravalvular leak requiring a reintervention 3.3% (1.7-6.1%). Technical success rate varied between 93.9% and 100%. Conventional median sternotomy was most commonly performed, ranging from 21.7% to 89.6%. Upper hemi-sternotomy was performed more often than anterior right thoracotomy, ranging from 10.4% to 63.3% and 2.2% to 26.1%. The mean transvalvular pressure gradient ranged between 9.0 and 10.3 mmHg at 1 year postoperatively. This review demonstrates that the technical success rate of the INTUITY or INTUITY Elite rapid deployment valve system is high, also in limited access aortic valve replacement. Mortality and cerebrovascular accident rates are low, but the need for postoperative permanent pacemaker implantation and reintervention rate for paravalvular leakage is increased.

Oversizing Increases Pacemaker Implantation Rate After Sutureless Minimally Invasive Aortic Valve Replacement.

Cardiac conduction system disturbances potentially leading to permanent pacemaker implantation are significant postoperative complications after aortic valve replacement. The aim of this study was to assess the impact of sutureless prosthetic valve oversizing on permanent pacemaker implantation rate. This multicenter retrospective study included 306 patients who underwent minimally invasive aortic valve replacement with the Perceval sutureless valve. Oversizing was determined by the implanted valve size indexed to body surface area. Data were analyzed with a multivariable logistic regression model. This study confirmed excellent postoperative results for minimally invasive aortic valve replacement with right anterior minithoracotomy approach and rapid deployment sutureless valves. Mortality rate was 1%. Eighteen (5.9%) patients received a new permanent pacemaker. Multivariable logistic regression model (P = 0.05) found oversizing as significant risk factor (P = 0.017) for permanent postoperative pacemaker implantation independent of patient age. There was a significant negative correlation between the indexed implanted valve size and the mean and peak postoperative transvalvular gradients (P < 0.001). Oversizing of sutureless prosthetic aortic valves is a risk factor for postoperative permanent pacemaker implantation. Proper sizing of Perceval is important to avoid complications and ensure optimal valve performance.

Reduced Permanent Pacemaker Implantation in Patients With Stentless Freedom SOLO Compared With Stented Perimount Magna Aortic Bioprostheses: A Propensity Score Weighted Analysis

Postoperative permanent pacemaker implantation (PPI) after conventional aortic valve replacement (AVR), due to new-onset severe conduction system disorders, is required in approximately 7% of patients. This study investigated the need for PPI after AVR with conventional stented Perimount Magna compared with the Freedom SOLO (FS) stentless valve (Sorin Group, Saluggia, Italy), now LivaNova plc (London, UK) that uses a strictly supra-annular, subcoronary running suture implantation technique, sparing the vulnerable interleaflet triangles in the region of the septum membranaceum. A total of 413 consecutive patients (71.4±9.2 yrs, 178 [43.1%] female) underwent isolated AVR using the stented Perimount Magna (n=264) or the stentless FS (n=149) bioprosthesis. Propensity score weighted analysis was used to account for patient-specific and procedural-specific variables, and to identify the prosthesis-specific need for early postoperative PPI within 30 days of AVR. Twenty (20) patients required PPI, which was associated with longer intensive care unit (2.1±1.7 vs 1.5±3.0 days, p<0.001) and overall hospital stays (13.8±5.2 vs 10.7±5.3 days, p<0.001) compared with no PPI. Propensity weighted logistic regression including cross-clamp times identified that use of the stented Perimount Magna was associated with increased need for PPI, as compared with the FS, with an odds ratio 5.8 (95% CI, 1.09-30.76; p=0.039). After corrections for all plausible confounders, AVR with the stented Perimount valve was associated with an odds ratio of almost 6 for an increased early postoperative need for pacemaker implantation compared with the FS stentless valve. This finding can be explained by the conventional implantation technique, which is potentially associated with mechanical trauma to the conducting system.

305Pacemaker therapy after cardiac valve replacement surgery: impact on heart failure hospitalizations

Abstract Background Left ventricular (LV) function is a major determinant of long-term outcomes after valve replacement surgery. Although conventional (right ventricular) pacemaker therapy is life-saving, it may cause heart failure (HF). Aims To determine whether permanent pacemaker implantation (PPI) confers a risk of HF in surgical valve recipients. Methods The primary endpoint of HF hospitalization and the secondary endpoints of total mortality and total mortality / HF hospitalizations were compared in valve recipients with and without PPI. Traditional as well as multi-state, multivariable modelling was used to assess the influence of PPI on clinical outcomes. Results Amongst patients (n = 135,242) undergoing a first aortic (AVR; n = 111,674), mitral (MVR; n = 18,402) valve replacement, or AVR + MVR (n = 5,166) over 14 years in 176 centre, 12,952 (10.6%) had a PPI at any time during follow-up and 5,805 (4.3%) underwent PPI postoperatively. After 3.9 yrs (median, interquartile range: 6.1), heart failure (HF) hospitalizations (HR: 1.47, 95% C.I. 1.36-1.59), total mortality (HR: 1.10, 95% C.I. 1.05-1.16) and total mortality or HF hospitalizations (HR: 1.17, 95% C.I. 1.12-1.22; see figure) were higher in patients with post-operative PPI than in patients without. Multi-state modelling revealed that the transition hazard from PPI at any time to HF hospitalizations was markedly higher (transition hazard rate: 0.29, 95% C.I. 0.24-0.36) than from valve replacement surgery to HF hospitalization. Conclusions After valve replacement surgery, PPI is associated with increased HF hospitalization and total mortality, particularly after dual valve replacements. Abstract Figure.

Incidence of permanent pacemaker implantation after valve replacement surgery

Our study aimed to explore the incidence and risk factors of permanent pacemaker implantation (PPI) after valve replacement surgery (VR). The influence of long-term pacemaker dependency on cardiac structure and function at the 1‑year follow-up was also assessed. The demographic and surgical data of all consecutive patients who underwent VR between 2013 and 2016 were collected. Univariate and multivariate analyses were performed to identify variables independently associated with PPI after VR. A 1‑year follow-up was undertaken of patients who underwent dual-chambers pacemaker after VR because of complete atrioventricular block (AVB). Long-term pacemaker dependency and recovery of cardiac structure and function were evaluated. There were 5320 consecutive patients with VR. The incidence of postoperative PPI was 2.42%. Multivariate analysis indicated that among the 62patients who underwent PPI due to AVB and sick sinus syndrome, isolated aortic valve replacement (AVR; OR: 2.24, p < 0.05), VR combined with ventricular septal defect (VSD) repair (OR: 6.78, p < 0.05), and VR with aortic root and arch surgery (OR: 4.14, p < 0.05) were independent predictors of PPI after surgery. In total, 89.6% (43/48) of the survivors showed pacemaker dependency. Of these 43patients, 24 had enlarged left heart before VR. Compared with preoperative values, the left atrial and left ventricular end-diastolic diameter post-PPI decreased significantly, while left ventricular ejection fraction was not significantly different. Isolated AVR, VR concomitant with VSD repair, and VR with aortic root and arch surgery are independent predictors of PPI after VR. The majority of patients do not recover from AVB disorders and there is no significant negative effect on recovery of cardiac structure and function.