Pacemaker Implantation Rate Research Articles

The first clinical data of the SAPIEN 3 aortic valve in the treatment of aortic stenosis in China.

Data on outcomes following transcatheter aortic valve replacement with SAPIEN 3 in China is limited as it was approved by the National Medical Products since 2020. The present study was designed to collect clinical data on the SAPIEN 3 aortic valve in Chinese patients with bicuspid aortic valve and tricuspid aortic valve stenosis. We analyzed the patient characteristics, procedural features and procedural outcomes of the first 438 patients (223 for bicuspid aortic valve and 215 tricuspid aortic valve) from 21 provinces in 74 sites treated with the SAPIEN 3 valve system for transcatheter aortic valve replacement between September 2020 and May 2022. Procedural mortality was 0.7%. 5 cases during the operation were converted to surgery. Among 438 cases, permanent pacemaker implantation was performed in a total of 12 cases (2.7%). The patient had severe leaflet calcification of the aortic valve, with moderate and severe calcification reaching 39.7% and 35.2% respectively. The size of the implanted valves was predominantly 26 mm and 23 mm, reaching 42.5% and 39.5% respectively. The incidence of moderate or severe perivalvular leak in the postoperative period was 0.5%, with a predominance of 90/10 and 80/20 valve deployment height. There was a significant difference in the deployment height of the valve between bicuspid aortic valve and tricuspid aortic valve, with the bicuspid aortic valve having a more deployment height of 90/10. Annulus size in bicuspid aortic valve group was significantly larger than tricuspid aortic valve group. Valve sizing for oversized, within size, and undersized were different between bicuspid aortic valve and tricuspid aortic valve. Procedural success rates were high, with similar and good results for bicuspid aortic valve and tricuspid aortic valve, low perivalvular leak for both valve types, and low permanent pacemaker implantation rates for both valve types. Annulus size, valve sizing and coronary artery height were significantly different in the BAV and TAV group.

Features and outcomes of bailout repeat transcatheter aortic valve implantation (TAVI): the Bailout Acute TAVI-in-TAVI to Lessen Events (BATTLE) international registry

AimTranscatheter aortic valve implantation (TAVI) is a mainstay in the management of severe aortic stenosis in patients with intermediate to prohibitive surgical risk. When a single TAVI device fails and cannot be retrieved, TAVI-in-TAVI must be performed acutely, but outcomes of bailout TAVI-in-TAVI have been incompletely appraised. We aimed at analyzing patient, procedural and outcome features of patients undergoing bailout TAVI-in-TAVI in a multicenter registry.MethodsDetails of patients undergoing bailout TAVI-in-TAVI, performed acutely or within 24 h of index TAVI, in 6 international high-volume institutions, were collected. For every case provided, 2 same-week consecutive controls (prior TAVI, and subsequent TAVI) were provided. Outcomes of interest were procedural and long-term events, including death, myocardial infarction, stroke, access site complication, major bleeding, and reintervention, and their composite (i.e. major adverse events [MAE]).ResultsA total of 106 patients undergoing bailout TAVI-in-TAVI were included, as well as 212 controls, for a total of 318 individuals. Bailout TAVI-in-TAVI was less common in younger patients, those with higher body mass index, or treated with Portico/Navitor or Sapien devices (all p < 0.05). Bailout TAVI-in-TAVI was associated with higher in-hospital rates of death, emergency surgery, MAE, and permanent pacemaker implantation (all p < 0.05). Long-term follow-up showed that bailout TAVI-in-TAVI was associated with higher rates of death and MAE (both < 0.05). Similar findings were obtained at adjusted analyses (all p < 0.05). However, censoring early events, outlook was not significantly different when comparing the two groups (p = 0.897 for death, and p = 0.645 for MAE).ConclusionsBail-out TAVI-in-TAVI is associated with significant early and long-term mortality and morbidity. Thus, meticulous preprocedural planning and sophisticated intraprocedural techniques are of paramount importance to avoid these emergency procedures.

Early experience with the Evolut FX self-expanding valve vs. Evolut PRO+ for patients with aortic stenosis undergoing TAVR

BackgroundThe Evolut FX system is the most recent generation of self-expandable transcatheter heart valve (THV) technology. This study aims to report the early experience and outcomes associated with this system. MethodsOur analysis included 200 consecutive patients who underwent transcatheter aortic valve replacement at our center from 2022 to 2023. The first cohort comprised the last 100 patients who received the Evolut PRO+ THV, while the second cohort included the first 100 patients who received the Evolut FX THV. The primary endpoints of the study were defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria, which included technical success (at exit from procedure), device success (at discharge or at 30 days), and early safety (at 30 days). ResultsThe study groups demonstrated no significant differences in baseline characteristics, including co-morbidities, pre-procedural imaging, and echocardiography. VARC-3 technical success rate was 99 % for both valves. The VARC-3 device success rate for the Evolut FX was 92 % compared to 97 % for the Evolut PRO+ (p = 0.12), and VARC-3 early safety rate was 80.1 % for the Evolut PRO+ vs. 81.5 % for the Evolut FX (p = 0.82). The in-hospital permanent pacemaker implantation rate for the Evolut FX was 12 % compared to 9 % for the Evolut PRO+ (p = 0.21). There were no differences in clinical outcomes, such as mortality or stroke, between the two groups. ConclusionsThe Evolut FX THV performed well when used for patients with severe aortic stenosis, demonstrating high success with low complication rates when compared to an earlier generation of self-expanding THV.

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

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

Outcomes of Rapid Deployment Aortic Valve Replacement: Early Experience in Wellington Hospital

Rapid deployment (RD) aortic valve replacement (AVR) using the Edwards Intuity Elite Valve System is a significant breakthrough in advancement in comparison with other current conventional sutured surgical AVR. This study aimed to analyse early experiences using this novel bioprosthesis. This 60-month prospective study, between July 2017 and July 2022, found that 59 patients had RD bioprosthesis implanted at this institution. Median follow-up period was 12 months. Baseline preoperative characteristics, isolated or concomitant procedures, valve prosthesis-related events, survival rates, and valve haemodynamics were evaluated. Primary endpoints were pacemaker implantation (PPM) rates, neurological events, paravalvular leaks, and early 30-day mortality rates. Secondary endpoints were reintervention, valve degeneration, arrhythmia, hospital stay, and readmission rates. Approximately 64% were males, with the mean age of 75±3 years. Isolated AVR was performed in 54% and the rest were concomitant procedures. Cardiopulmonary bypass and cross-clamping times were acceptable. In the isolated AVR group, the early PPM implantation rates were 5%, with 1.7% of patients experiencing a minor stroke event. One patient had paravalvular leak, which was moderate in haemodynamics. Mean gradient at discharge was 11±3 mmHg. There was no early inpatient mortality in the isolated AVR group, and the 30-day post-discharge mortality was zero. Re-operation rates and valve degeneration rates were zero. This study found promising and excellent early results in this small cohort of patients, validating for more usage of rapid deployment AVR in suitable patients.

Associated rate of pacemaker implantation following transcatheter aortic valve implantation according to age: A nationwide study

Associated rate of pacemaker implantation following transcatheter aortic valve implantation according to age: A nationwide study

Permanent pacemaker implantation following transcatheter aortic valve implantation: a systematic review and Bayesian network meta-analysis

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Permanent pacemaker implantation (PPI) remains a common complication after transcatheter aortic valve implantation (TAVI). Different transcatheter heart valves (THVs) exist, and newly approved devices are growing. A comparison according to the mechanisms of TAVI prosthesis with longer follow-up needs to be made. We address this issue using a systematic review and a Bayesian network meta-analysis (NMA). Methods A systematic literature review was carried out up to Oct 31, 2022, to identify studies reporting the use of balloon-expandable valves (BEVs), self-expandable valves (SEVs), and mechanically expandable valves (MEVs). We compared the various THVs, or standard medical treatment (STD), with a common comparator of surgical aortic valve replacement (SAVR) concerning PPI. Data at the most extended follow-up for each study were extracted. A random-effects Bayesian NMA was used to calculate odds ratios (OR) and 95% credible intervals (CrI) using MetInsight V4.0.0. The surface under the cumulative ranking area (SUCRA) probabilities was selected to calculate the ranking and hierarchy of the different treatments. The larger SUCRA indicates the greater likelihood of becoming the best intervention. Results We included 15 RCTs comprising 12.783 patients, among whom 8.585 underwent TAVI using various commercially available THVs, including BEVs (Sapien &amp; Sapien XT, Sapien 3), MEVs (Corevalve, Evolut &amp; Pro/R, Acurate Neo, Portico), and MEVs (Lotus). The median follow-up was 2.5 years (IQR 1-5). No significant differences in the risk of PPI were observed between STD: 1.70 [0.556, 5.39], Sapien &amp; Sapien XT: 1.39 [0.834, 2.41], Sapien 3: 1.70 [0.977, 2.88], and Acurate Neo: 1.68 [0.768, 3.789], compared with SARV. All the other THVs (Corevalve: 3.07 [1.99. 4.959]; Evolut &amp; Pro/R: 3.19 [1.80, 6.03]; Lotus: 5.22 [2.08, 13.7]; Portico: 7.22 [2.85, 19.4]) showed significant differences in the risk of PPI compared with SARV. In Bayesian ranking results, Sapien &amp; Sapien XT had the highest chance (77%) of providing a lower PPI rate. Meanwhile, Portico THV was ranked the worst (5%) regarding the likelihood of PPI rate (Figure 1). According to the mechanism, all the THVs showed a higher risk for PPI than SARV (BEVs: 1.60 [1.01, 2.54]; SEVs: 3.09 [1.97, 4.96]; and MEV: 5.30 [1.62, 17.7]). STD: 1.92 [0.518, 7.14] had a non-significant PPI rate compared with SARV. SUCRA plot showed that SARV was the intervention with the lowest (95%) probability of PPI, followed by BEVs (65%), STD (55%), SEVs (27%) and MEVs (7%) (Figure 2). In both analyses, the assessment of inconsistency between direct and indirect estimates was not significant (P &amp;gt; 0.05). Conclusions This NMA of RCTs includes a more significant number of patients with longer follow-up. We demonstrated that BEVs are associated with lower PPI rates than SEVs and MEVs. Some newer generations of THVs (Acurate Neo, Evolut R/Pro) performed better than the older ones, reducing the PPI rate.

Long-term outcomes of concomitant suture bicuspidization technique to treat mild or moderate tricuspid regurgitation in patients undergoing mitral valve surgery.

To investigate the long-term outcomes of concomitant suture bicuspidization to treat mild or moderate tricuspid regurgitation at the time of mitral valve surgery. Data from patients who underwent mitral valve surgery for degenerative mitral valve regurgitation with mild or moderate tricuspid regurgitation and annular dilatation between January 2009 and December 2017 were analyzed. The cohort was divided into 2 groups: mitral valve surgery alone and mitral valve surgery with concomitant tricuspid valve repair. A total of 196 patients were included in the study. Mitral valve surgery alone and mitral valve surgery with concomitant tricuspid valve repair were performed in 91 (46.4%) and 105 (53.6%) patients, respectively. Propensity score matching analysis identified 54 pairs. In the matched cohort, 30-day mortality (0.0% vs 1.9%, P = 1.0) and new permanent pacemaker implantation (11.1% vs 7.4%, P = 0.740) did not differ significantly between groups. After a mean follow-up of 6.0 (2.8) years, mitral valve surgery with concomitant tricuspid valve repair was not associated with increased mortality risk compared to mitral valve surgery alone (hazard ratio 1.04, 95% confidence interval 0.47-2.28, P = 0.927) with 10-year overall survival rates of 69.9% and 77.2%, respectively. Furthermore, mitral valve surgery with concomitant tricuspid valve repair was associated with a significantly reduced progression of tricuspid valve regurgitation (P < 0.001). Patients undergoing mitral valve surgery with concomitant tricuspid valve repair had similar 30-day and long-term survival, similar permanent pacemaker implantation rate, and reduced progression of tricuspid valve regurgitation compared to those undergoing mitral valve surgery alone.

TAVI autoexpandible con superposición de senos coronarios frente a la técnica tradicional: alteraciones en el ECG y eventos cardiovasculares al año

Introduction and objectivesTranscatheter aortic valve implantation (TAVI) using the cusp overlap technique (COT) has shown a lower pacemaker implantation rate at 30 days. The objective of this study was to compare electrocardiogram changes and clinical outcomes between COT and the traditional technique (TT) at 1 year of follow-up. MethodsObservational, retrospective, nonrandomized study of consecutive patients undergoing TAVI between January 2015 and January 2021. Patients were matched using a propensity score and the TT was compared with COT. The primary endpoints were electrocardiogram changes and a combined endpoint including pacemaker implantation, hospitalization, or cardiovascular death at 1 year. ResultsWe included 254 patients. After propensity score matching, 184 patients (92 per group) remained. There were no statistically significant differences in baseline characteristics. At 1 year, COT patients showed a significant reduction in new onset left bundle branch block (49% vs 27%, P=.002) and less P wave (13.1±21.0 msec vs 5.47±12.5 msec; P=.003) and QRS prolongation (29.77±27.0 msec vs 16.38±25.4 msec, P <.001). COT was associated with a significant reduction in the occurrence of the primary endpoint (SHR, 0.39 [IC95%, 0.21-0.76]; P=.005). ConclusionsAt 1 year of follow-up, COT reduced the incidence of new onset left bundle branch block and diminished QRS and P wave widening compared with the TT. COT was also associated with a statistically significant reduction in the occurrence of the combined primary cardiovascular endpoint.

Última generación de prótesis percutáneas expandibles con balón y autoexpandibles en la estenosis aórtica bicúspide: estudio TRITON

Introduction and objectivesNo comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis. MethodsMulticenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+(EP+). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days. ResultsA total of 360 patients (age 76.6±7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP+(30.3%). The mean STS score was 3.6±1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP+: 81.3%), mainly due to higher residual aortic gradients with S3U and greater≥moderate aortic regurgitation (AR) with EP+. No significant differences were found in the unadjusted rate of pacemaker implantation. ConclusionsIn patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP+showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP+, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes.Full English text available from:www.revespcardiol.org/en

Clinical outcomes of the ACURATEneo2transcatheter heart valve: a prospective, multicenter, observational, post-market surveillance study.

The next-generation ACURATE neo2 transcatheter aortic valve was designed for simplified implantation and to mitigate the risk of paravalvular leak (PVL) compared to the earlier device. To collect clinical outcomes and device performance data, including echocardiography and 4-dimensional computed tomography (4D-CT) data, with the ACURATE neo2 transcatheter heart valve in patients with severe aortic stenosis (AS). ACURATE neo2 PMCF is a single-arm, multicentre study of patients with severe AS treated in routine clinical practice. The primary safety endpoint was all-cause mortality at 30-days. The primary imaging endpoint was hypo-attenuated leaflet thickening (HALT), measured by core laboratory-adjudicated 4D-CT at 30 days. Secondary endpoints included VARC safety endpoints, procedural success, and evaluation of valve performance via core laboratory-adjudicated echocardiography. The study enrolled 250 patients at 18 European centres (mean age: 80.8 years; 63.6% female; mean STS score: 2.9±2.0%); 246 (98.4%) were successfully treated with ACURATE neo2. The 30-day rates for mortality and disabling stroke were 0.8% and 0%, respectively. The new permanent pacemaker implantation rate was 6.5%. HALT >50% was present in 9.3% of patients at 30 days. Valve haemodynamics improved from baseline to 30 days (mean aortic valve gradient: from 47.6±14.5 mmHg to 8.6±3.9 mmHg; mean aortic valve area: from 0.7±0.2 cm2 to 1.6±0.4 cm2). At 30 days, PVL was evaluated as none/trace in 79.2% of patients, mild in 18.9%, moderate in 1.9%, and severe in 0%. The study results support the safety and efficacy of TAVI with ACURATE neo2 in patients in routine clinical practice.

How to predict conduction disturbances after transcatheter aortic valve replacement.

Transcatheter aortic valve replacement (TAVI) has evolved into the gold standard management option for high-risk patients with severe aortic stenosis. Despite identifying procedural, electrocardiographic, and clinical predictors of important post-procedural conduction disturbances (left bundle branch block and high-degree atrioventricular block) and despite continuous technological refinement of transcatheter aortic valves, the rate of post-procedural conduction disturbance remains high and challenging to manage. New strategies are required to reduce the overall rate of post-procedural permanent pacemaker implantations. In this article, we will review the incidence, predictive factors, and clinical implications of conduction disturbances after TAVI.

COVID-19 pandemic: Impact on the cardiac implantable electronic devices' implantation rates in Croatia.

Coronavirus disease 2019 (COVID-19) pandemic has influenced health-care organization worldwide, including management of non-communicable diseases. The aim of this study was to determine the impact of COVID-19 pandemic on cardiac implantable electronic devices' (CIEDs) implantation rates in Croatia. A retrospective, observational, national study was conducted. The data on CIEDs' implantation rates from 20 Croatian implantation centres, between January 2018 and June 2021, were extracted from the national Health Insurance Fund registry. Implantation rates before and after COVID-19 pandemic started, were compared. The overall numbers of CIED implantations in Croatia during COVID-19 pandemic were not different in comparison to 2 years pre-COVID-19 time (2618 vs. 2807, p = .081). The pacemaker implantation rates decreased significantly (by 45%) during April (122 vs. 223, p < .001) and May 2020 (135 vs. 244, p = .001), as well as during November 2020 (177 vs. 264, p = .003), but significantly increased during summer months 2020 comparing to 2018 and 2019 (737 vs. 497, p<0.001). The ICD implantation rates decreased significantly by 59% in April 2020 (26 vs. 64, p = .048). To the authors best knowledge this is a first study including complete national data on CIED implantation rates and COVID-19 pandemic impact. A significant reduction in number of both pacemaker and ICD implants during specific months of the COVID-19 pandemic was determined. However, afterwards compensation in implants resulted in similar total number when the complete year was evaluated.

Conduction Disorders And Their Clinical Impact After Sutureless/Rapid Deployment Aortic Bioprosthesis.

Aortic stenosis remains the number one heart valve pathology. The drive to improve the surgical outcomes brought to focus rapid deployment valves (RDV), which reduce aortic cross-clamping and cardio-pulmonary bypass (CPB) times. However, some centers have reported a higher rate of conduction abnormalities and permanent pacemaker (PPM) implantation. The aim of this study was to investigate the incidence of conduction abnormalities after aortic valve replacement with RDV, as well as its impact on immediate postoperative outcomes. Retrospective analysis of associated conductions disorders and PPM implantation rates, as well as post-operative outcomes of all patients undergoing isolated aortic valve replacement between April 2014 and December 2019 with an RDV. Comparative analysis between the group with PPM implantation and the one with no PPM implantation. Patients with previous PPM implantation, reoperations and patients with missing pre or postoperative ECG data were excluded. We studied 201 patients. The majority of conduction abnormalities were left bundle branch block (54,0%). Twenty-six PPM were implanted (12,6%). Pre-operative characteristic between the groups were similar and little differences were found in regard to most complications. However, the PPM group showed significantly higher rates of stroke (7.7% vs 0.0%, p=0.016) and hemodynamic support for longer than 24 hours (60.0% vs 36.1%, p=0.028). From the multivariable analysis, preoperative right bundle branch block was the only independent risk factor associated with PPM. PPM implantation rates with RDV are relatively high and are associated with prolonged hospital and ICU stays, postoperative stroke rates and requirement of aminergic support. Their use should be made on a case-by-case basis taking into consideration the existence of preoperative conduction disorders, especially right bundle branch block.

Mid-Term Clinical Outcomes and Hemodynamic Performances of Trifecta and Perimount Bioprostheses following Aortic Valve Replacement.

Aims of the Study: We evaluated the clinical outcome and the hemodynamic and freedom from structural valve degeneration of two standard aortic bioprostheses. Methods: Clinical results, echocardiographic findings and follow-up data of patients operated for isolated or combined aortic valve replacement with the Perimount or the Trifecta bioprosthesis were prospectively collected, retrospectively analysed and compared. We weighted all the analyses by the inverse of the propensity of choosing either valves. Results: Between April 2015 and December 2019, 168 consecutive patients (all comers) underwent aortic valve replacement with Trifecta (n = 86) or Perimount (n = 82) bioprostheses. Mean age was 70.8 ± 8.6 and 68.8 ± 8.6 years for the Trifecta and Perimount groups, respectively (p = 0.120). Perimount patients presented a greater body mass index (27.6 ± 4.5 vs. 26.0 ± 4.2; p = 0.022), and 23% of them suffered from angina functional class 2-3 (23.2% vs. 5.8%; p = 0.002). Mean ejection fraction was 53.7 ± 11.9% (Trifecta) and 54.5 ± 10.4% (Perimount) (p = 0.994), with mean gradients of 40.4 ± 15.9 mmHg (Trifecta) and 42.3 ± 20.6 mmHg (Perimount) (p = 0.710). Mean EuroSCORE-II was 7 ± 11% and 6 ± 9% for the Trifecta and Perimount group, respectively (p = 0.553). Trifecta patients more often underwent isolated aortic valve replacement (45.3% vs. 26.8%; p = 0.016) and annulus enlargement (10.5% vs. 2.4%; p = 0.058). All-cause mortality at 30 days was 3.5% (Trifecta) and 8.5% (Perimount), (p = 0.203) while new pacemaker implantation (1.2% vs. 2.5%; p = 0.609) and stroke rate (1.2% vs. 2.5%; p = 0.609) were similar. Acute MACCE were observed in 5% (Trifecta) and 9% (Perimount) of patients with an unweighted OR of 2.22 (95%CI 0.64-7.66; p = 0.196) and a weighted OR of 1.10 (95%CI: 0.44-2.76, p = 0.836). Cumulative survival at 24 months was 98% (95%CI: 0.91-0.99) and 96% (95%CI: 0.85-0.99) for Trifecta and Perimount groups, respectively (log-rank test; p = 0.555). The 2-year freedom from MACCE was 94% (95%CI: 0.65-0.99) for Trifecta and 96% (95%CI: 0.86-0.99) for Perimount (log-rank test; p = 0.759, HR 1.46 (95%CI: 0.13-16.48)) in the unweighted analysis (not estimable in the weighted analysis). During the follow-up (median time: 384 vs. 593 days; p = 0.0001) there were no re-operations for structural valve degeneration. Mean valve gradient at discharge was lower for Trifecta across all valve sizes (7.9 ± 3.2 vs. 12.1 ± 4.7 mmHg; p < 0.001), but the difference did not persist during follow-up (8.2 ± 3.7 mmHg for Trifecta, 8.9 ± 3.6 mmHg for Perimount; p = 0.224); Conclusions: Postoperative outcome and mid-term follow-up were similar. An early better hemodynamic performance was detected for the Trifecta valve but did not persist over time. No difference in the reoperation rate for structural valve degeneration was found.

Impact of the use of cusp-overlap projection on the incidence of permanent pacemaker implantation post-transcatheter aortic valve implantation with self-expanding valves

IntroductionCurrent rates of permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVI) range between 3.4% and 25.9%. PPMI is associated with a worse prognosis. A lower valve implantation depth is associated with an increased risk of conduction disturbances. Theoretically, cusp-overlap projection (COP) has the potential to enable higher valve deployment. ObjectiveTo compare the 30-day PPMI incidence post-TAVI using self-expanding valves according to the fluoroscopic guidance technique. MethodsThis retrospective single-center study assessed consecutive patients undergoing TAVI with CoreValve™ valves between April 2019 and November 2021, grouped according to the fluoroscopic guidance technique (COP vs. coplanar implantation technique [CIT]). ResultsA total of 122 patients were included, predominantly women (52.5%), with a mean age of 81.6±5.5 years. COP was used in 49.2% of the sample. The CIT group had a significantly higher prevalence of previous beta-blocker use (p<0.01), lower baseline left ventricular ejection fraction (p=0.04) and a higher EuroSCORE II (p=0.02). The 30-day PPMI rate was 27.9% (n=34), with no significant difference between the COP and CIT groups (26.7% vs. 29.0%, p=0.77). Complete atrioventricular block was the main cause (38.5%). Likewise, mean fluoroscopy time (p=0.14) and contrast volume (p=0.35) used were similar between the two groups. Radiation dose was lower in the COP group (p=0.02). There was no significant difference between post-TAVI grades III and IV aortic valve regurgitation (p=0.27) and there were no cases of periprocedural acute coronary occlusion. ConclusionsThis study shows that the COP technique, although safe and not associated with increased complexity, did not significantly reduce the 30-day PPMI rate compared to the traditional CIT view.

Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study

Introduction and objectivesNo comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis. MethodsMulticenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+(EP+). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days. ResultsA total of 360 patients (age 76.6±7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP+(30.3%). The mean STS score was 3.6±1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP+: 81.3%), mainly due to higher residual aortic gradients with S3U and greater≥moderate aortic regurgitation (AR) with EP+. No significant differences were found in the unadjusted rate of pacemaker implantation. ConclusionsIn patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP+showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP+, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes.

Conventional Biological versus Sutureless Aortic Valve Prostheses in Combined Aortic and Mitral Valve Replacement.

Sutureless aortic valve prostheses have proven to provide a significant decrease in procedural, cardiopulmonary bypass and cross-clamp time, leading to a significant reduction in mortality risk in elderly high-risk cohorts. In this study, we sought to review our institutional experience on the sutureless aortic valve replacement (SU-AVR) and the concomitant mitral valve replacement (SMVR), comparing the combined conventional surgical aortic valve replacement (SAVR) with SMVR. Between March 2018 and July 2022, 114 consecutive patients underwent a combined aortic and mitral valve replacement at our institution. We stratified the patients according to the operative procedures into two groups and matched them 1:2: Group 1 underwent a combined conventional SAVR and SMVR (n = 46), and Group 2 included combined SU-AVR with Perceval prosthesis and SMVR (n = 23). No significant differences in the preoperative characteristics were present. SU-AVR combined with SMVR demonstrated excellent haemodynamic performance, comparable to that of SAVR plus SMVR, with median postoperative gradients over the aortic valve of 4 mmHg (IQR 3.0-4.0) in Group 1 and 4 mmHg (IQR 3.0-4.0) in Group 2 (p = 0.67). There was no significant difference in the occurrence of postoperative major adverse events such as death, stroke, myocardial infarction and kidney failure between the groups. There was also no significant difference in the permanent pacemaker implantation rate, paravalvular leakage or valve dislocation. We also could not detect any significant difference in postoperative mortality between the groups. SU-AVR has proven to be a reliable alternative to conventional valve prostheses in patients with multivalve disease undergoing combined aortic and mitral valve replacement, offering shorter procedural time and outstanding hemodynamic performance compared to the conventional surgical method.

Outcomes Associated With Early vs. Delayed Invasive Strategy in NSTEMI Complicated by High Degree AV Block: A Nationwide Analysis.

Background: High degree atrioventricular block (HDAVB) is an uncommon complication of non-ST-segment elevation myocardial infarction (NSTEMI) that frequently necessitates pacemaker implantation. This contemporary analysis compares need for pacemaker implantation based on the timing of intervention in acute NSTEMI complicated by HDAVB.Methods: We used 2016-2017 National Inpatient Sample database to identify admissions with NSTEMI and HDAVB. Time to coronary intervention from initial admission was used to segregate the admissions into two groups: early invasive strategy (EIS) (<24 hours) and delayed invasive strategy (DIS) (>24 hours). Multivariable linear and logistic regression analysis was performed to compare in-hospital outcomes among the two groups.Results: Out of 949,984 NSTEMI related admissions, coexistent HDAVB was present in 0.7% (n=6725) patients. Amongst those, 55.61% (n=3740) hospitalizations included invasive intervention (EIS=1320, DIS=2420). Patients treated with EIS were younger (69.95 years vs. 72.38 years, P<0.05) and had concomitant cardiogenic shock. Contrarily, prevalence of chronic kidney disease, heart failure, and pulmonary hypertension was higher in DIS group. EIS was associated with lower length of stay and total hospitalization cost. In-hospital mortality and pacemaker implantation rates were not significantly different between patients in the EIS and DIS groups.Conclusion: HDAVB is a rare complication of NSTEMI and often associated with right coronary artery disease. The timing of revascularization does not appear to influence the rate of pacemaker placement in NSTEMI complicated by HDAVB. Further studies are needed to assess if early invasive strategy can benefit all patients with NSTEMI and HDAVB.

Interventional versus Surgical Treatment of Degenerated Freestyle Prosthesis.

Bioprosthetic stentless aortic valves may degenerate over time and will require replacement. This study aimed to evaluate early- and mid-term outcomes after isolated surgical redo aortic valve replacement (redo-SAVR) and transcatheter valve-in-valve implantation (TAVI-VIV) for degenerated stentless Freestyle bioprostheses. We reviewed records of 56 patients at a single center. Overall, 37 patients (66.1%) received TAVI-VIV and 19 (33.9%) received redo-SAVR. Thirty-day survival was similar in both groups (100%). One-year survival was comparable between groups (97.3% in TAVI-VIV and 100% in redo-SAVR, p = 1.0). The difference in mid-term survival after adjusting for age and EuroScore II was not significant (p = 0.41). The incidence of pacemaker implantation after TAVI-VIV was higher than after redo-SAVR (19.4% vs. 0%, p = 0.08). The 30-day and 1-year survival rates after both procedures were outstanding, irrespective of baseline characteristics. Isolated redo-SAVR should be favored in young patients, as the pacemaker implantation rate is lower. TAVI-VIV for degenerated Freestyle prosthesis can be a method of choice in elderly patients and those with high operative risk.