Pacemaker Implantation Rate Research Articles

Contemporary Outcomes of TAVR Using a Balloon-Expandable Valve in Patients With Severe Mitral Stenosis: Insights From the Transcatheter Valve Therapies Registry.

While initial data for transcatheter aortic valve replacement (TAVR) in aortic stenosis patients with mitral stenosis (MS) suggested a poor short-term prognosis, outcomes for contemporary balloon-expandable valves remain unknown. The aim of this retrospective multicenter registry study was to compare the potential impact of MS on TAVR outcomes with balloon-expandable valves. Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry and Centers for Medicare & Medicaid Services claims data were used to obtain a cohort of 327 925 patients who underwent TAVR with current balloon-expandable valves (SAPIEN 3, SAPIEN 3 Ultra, or SAPIEN 3 Ultra Resilia) between June 2015 and December 2022 across 791 sites. Severe MS (defined as >10 mm Hg mean gradient or <1.5 cm2 area) was compared with mild or less MS (defined as <5 mm Hg mean gradient and >2 cm2 area) using propensity matching to minimize confounding variables. Patients with severe MS (n=8500; 2.6%) had a higher number of comorbid conditions, Society of Thoracic Surgeons risk scores, and were more often women than patients with mild or less MS at the time of index TAVR. While patients with severe MS had worse outcomes at 30 days, when propensity-matched, patients exhibited similar 30-day rates of death (3.2% versus 3.0%), stroke (2.4% versus 2.2%), major vascular complications (1.6% versus 1.6%), device implant success (98.9% versus 99.2%), and new dialysis (0.7% versus 0.5%), with higher rates of pacemaker implantation (11.3% versus 9.4%; P<0.001). By 1 year, there was no difference in the change in the KCCQ (Kansas City Cardiomyopathy Questionnaire) overall score from baseline to 1 year (30.7±27.0 versus 31.9±27.0; P=0.07). By 3 years, an increase in the mortality rate (45.1% versus 40.9%; P<0.001) of patients with severe MS was observed. MS in isolation is not associated with worsened short-term outcomes among patients undergoing contemporary TAVR with balloon-expandable valves.

Comparison of Transcatheter versus Surgical Tricuspid Repair among Patients with Tricuspid Regurgitation: Two-Year Results

Background: Evidence is limited as to whether outcomes differ between patients with tricuspid regurgitation (TR) treated with tricuspid transcatheter edge-to-edge repair (T-TEER) versus surgical tricuspid valve repair. We aimed to compare outcomes between these two approaches. Methods: We analyzed the data on Medicare fee-for-service beneficiaries aged 65 to 99 with TR who underwent T-TEER or isolated surgical repair between July 2016 and December 2020. The primary outcome was two-year all-cause mortality. Other outcomes included in-hospital mortality and permanent pacemaker implantation as well as two-year heart failure hospitalization and tricuspid valve reintervention. A propensity score matching weight analysis was used to adjust for potential confounders. Results: A total of 1,143 patients were included (409 T-TEER versus 734 surgery). The proportion of T-TEER cases increased from 2% in the third quarter of 2016 to 67% in the last quarter of 2020 among all isolated TR procedures. After adjustment for potential confounders, we found no evidence that two-year all-cause mortality differs between patients treated with T-TEER versus surgical repair (adjusted HR, 0.84; 95% CI, 0.63–1.13). Patients treated with T-TEER experienced lower in-hospital mortality (2.5% versus 12.5%, P&lt;0.001) and permanent pacemaker implantation rates (0.0% versus 12.7%, P&lt;0.001) than those treated by surgical repair. At two years, we found no differences in heart failure hospitalizations, but tricuspid valve reinterventions were more frequent in the T-TEER group (subdistribution HR, 8.03; 95% CI, 2.87–22.48). Conclusions: Among Medicare beneficiaries with TR, two-year mortality rate was comparable between T-TEER and surgical repair. T-TEER showed advantages in perioperative outcomes, including lower in-hospital mortality and pacemaker implantation rates, while tricuspid valve reinterventions were more frequent in the T-TEER group. Further studies are necessary to refine indications, patient selections, and optimal timing for intervention with either treatment strategy.

Abstract 4124369: Mid-term Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Low to Moderate Risk Patients with Severe Aortic Stenosis: A Meta-analysis of Randomised Clinical Trials

Background: Several clinical trials have demonstrated non-inferiority of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) and low to intermediate surgical risk. However, mid-term results are still contentious. Question: Is TAVR superior to SAVR in the mid-term in terms of mortality outcomes or adverse cardiovascular events? Methods: We searched Embase, Pubmed and Cochrane databases for RCTs that compared TAVR with SAVR in patients with symptomatic severe AS with a follow-up of at least 4 years. Outcomes of interest were all-cause mortality and disabling stroke. Results: We included six RCTs involving 6,444 patients with severe AS, of whom 3,282 (50.9%) underwent TAVR. There was no difference in mortality from all causes (RR 1.08; 95%CI 0.94-1.25; p=0.30; I 2 =45%) and disabling stroke (RR 0.95; 95%CI 0.75-1.21; p=0.67; I 2 =9%) between groups. In the subgroup analysis, 5-year mortality (RR 1.28; 95%CI 1.10-1.49; I 2 =0%) was higher in the TAVI group. The new pacemaker implantation rate was higher in the TAVI group (RR 2.22; 95%CI 1.42-3.45; p=0.0004 ; I 2 =91%). However, new atrial fibrillation rate was higher in the SAVR group (RR 0.42; 95%CI 0.37-0.49; p=0.00001; I 2 =62%). Conclusion: Mid-term mortality and disabling stroke of patients with severe AS treated with TAVR or SAVR were similar.

Effect of age on clinical impact and mid-term denervation in patients undergoing cardioneuroablation

Cardioneuroablation (CNA) represents a promising therapy for recurrent vasovagal syncope (VVS), extrinsically driven atrioventricular block (AVB) and sinus node dysfunction (SND). However, effectiveness in patients aged 50 and above is not well-established. In this prospective study of patients referred for CNA, we compared syncope and pacemaker implantation free survival, heart rate (HR) variability (HRV) and quality of life between two age groups: group A (< 50 years) and B (≥ 50 years). A total of 50 patients were included (17 Group A and 33 Group B). The etiologies comprised VVS (56%), AVB (22%), and SND (22%). After a median follow-up of 17.0 (12.5–26.0) months, there were no differences of the combined endpoint of syncope or pacemaker implantation free-survival between groups (29.4.% vs. 21.2%; p-log-rank = 0.736). 84% of the entire cohort remained free from syncope, with a better but not significant syncope free survival in the older group (23.5% vs. 12.1%; p-log rank = 0.486). There were no differences in pacemaker implantation rate (A 5.9% vs. B 17.6%; p log-rank = 0.658). Notably, older patients had lower HR values post-procedure compared to younger patients (68.9 ± 13.3 vs. 80.4 ± 16.3 bpm; p = 0.012). Both groups exhibited a decrease in HRV parameters and an improvement in quality of life. In conclusion, CNA has comparable clinical benefits for patients aged 50 and above in terms of syncope or pacemaker implantation free survival and HRV reduction when compared to younger patients.

Three-Year Clinical and Hemodynamic Evaluation of the Hydra Self-Expanding Transcatheter Aortic Valve in Patients With Severe Aortic Stenosis.

The Hydra CE study revealed 1-year favorable efficacy of TAVR, showing a large effective orifice area (EOA), low gradient, and acceptable complication rates. We evaluated the 3-year clinical and hemodynamic outcomes of Hydra self-expanding transcatheter aortic valve (manufactured by Vascular Innovations Co Ltd, Nonthaburi, Thailand; a subsidiary of Sahajanand Medical Technologies Limited, India) in patients with symptomatic severe aortic stenosis at high or extremely high surgical risk. The Hydra CE study was a prospective, multicenter, single-arm study. A total of 157 patients were enrolled in the study, out of whom 54 patients from two centers (Lithuania and Poland) had provided consent for long-term follow-up at recruitment, with a planned 5-year follow-up period. The primary endpoint was all-cause mortality, and patients were followed up for up to 3 years, with an assessment of clinical and echocardiographic outcomes. Among the 54 patients, the average age was 81.0 ± 4.1 years. The mean STS score was 3.2 ± 2.0%. At 3 years, all-cause mortality had occurred in 14.8% of patients, including 3.7% cardiovascular deaths and 1.9% device-related deaths. There was a progressive enhancement in EOA that is, 0.68 ± 0.15 cm2 at baseline to 1.97 ± 0.52 cm2 at 3 years (p < 0.001) as well as significant improvement in the mean aortic valve gradient that is, 53.4 ± 14.24 mmHg at baseline to 8.6 ± 2.80 mmHg at 3 years (p < 0.001). New permanent pacemaker implantation rates up to 3-year follow-up was 12.9%. The 3-year results of the Hydra CE study demonstrated consistent improvements in hemodynamics over time. The study also revealed favorable safety and efficacy trends, along with low occurrences of new permanent pacemaker implantations and paravalvular leaks.

Conduction disorders after rapid deployment AVR compared to conventional AVR.

Objectives We evaluated and compared incidence and evolution of atrioventricular and intraventricular conduction disorders following rapid deployment AVR and conventional AVR. Methods 147 patients who underwent isolated rapid deployment AVR between 2017 and 2021 as well as 128 patients after conventional biological AVR in the same period were included in this study. ECGs recorded at baseline, discharge and 12 months were retrospectively analyzed. Results Patients in both groups had comparable a STS score (2.9 ± 1.6 vs 3.1 ± 2.2 p=0.32) and comparable baseline characteristics. At discharge the mean QRS width in the RDAVR group was significantly increased with 117.4  28.6 ms and a mean  QRS width of 21.7  26.3 ms (p<0.001) compared to baseline. No significant changes of QRS width were found in the AVR group with a mean value of 101.2  24.1 ms and a mean  QRS width of 3.9  23.9 ms at discharge (p=0.193). Left bundle branch block was increased in the RDAVR group after 12 months (19.3% vs 5.1% p<0.001) Permanent pacemaker implantation rates were significantly higher in the RDAVR group after 12months. (HR: 4.68; 95% CI: 2.23 - 7.43 p<0.001) Mortality did not differ in both groups after 12 months (HR: 1.09; 95% CI: 0.46 - 1.83; p = 0.835) Conclusions Patients after RDAVR showed significant higher rates of left bundle branch block with significantly increased QRS width and permanent pacemaker implantation after 12 months. However, higher mortality was not observed in the RDAVR group.

Sex-Based Differences in Long-Term Outcomes Following Transcatheter Closure of Patent Foramen Ovale for Cryptogenic Stroke.

Evidence from trials suggests that patent foramen ovale closure is superior to medical therapy alone in reducing stroke recurrence in men but not in women. Evidence from real-world data on the impact of sex on outcomes after patent foramen ovale closure, however, remains scarce. Therefore, the present study aimed to assess sex-based differences in long-term outcomes after transcatheter closure of patent foramen ovale. This was a single-center, retrospective cohort study enrolling patients who underwent transcatheter patent foramen ovale closure to prevent recurrent cerebrovascular events. Detailed information from medical charts was entered into a clinical registry, which has been linked to population-based administrative health databases in Ontario. Procedural, short, and long-term outcomes have been compared by sex. Of the 783 patients included in the sample, 349 (44.5%) were women and 434 (55.5%) were men. Women were younger and had a higher rate of migraine, while men had a higher prevalence of cardiovascular risk factors. No differences were observed in procedural and 30-day outcomes by sex. At a median follow-up of 14 years, the event rates of recurrent cerebrovascular events, survival, and new-onset atrial fibrillation were not different by sex. In adjusted analysis, men experienced higher rates of pacemaker implantation (hazard ratio, 5.62 [95% CI, 1.57-20.1]). No sex-based differences in recurrent cerebrovascular events, survival, or new-onset atrial fibrillation were observed in this study, suggesting equal benefits for both sexes. Future studies should report outcomes by sex to enhance the reproducibility of our findings and help support guideline development.

Contemporary implantation protocols enable markedly lower pacemaker rate for selfexpandable TAVR

Abstract Background Even in a low-risk cohort, the Evolut low-risk trial has reported a still rather high pacemaker implantation rate over 20%. In the recent years, contemporary implantation protocols have been introduced aiming on a higher implantation position. Purpose Data on a reduction of pacemaker rate in contemporary implantation practice is still limited. Methods We retrospectively analyzed baseline-characteristics and pacemaker-implantation rates after TAVR in patients being treated with a Medtronic Evolut Prosthesis for aortic valve stenosis in our center in the years 2018 (conventional implantation in 3-cusp view) vs. 2023 (contemporary implantation in cusp overlap technique). Results 160 Patients were retrospectively included. We found out, that contemporary implantation lead to a marked reduction of pacemaker rate (8.7 vs. 20.9%, p=0.047; HR 0.36[IQR 0.14-0.96; p=0.041]). While most baseline-parameters including age (83.5 (79.2/87.3) vs. 82.8 (79.4/86.2), p=0.654), LVEF (55.0 (54.3/57.8) vs. 55.0 (51.0/59.0), p=0.992) and overall risk score (Euroscore II 3.5 (2.5/4.7) vs. 3.6 (2.3/5.7), p= 0.726) had no relevant impact on pacemaker rate, female patients were less prone to receive a pacemaker (8.6% vs. 21.3%, p=0.030). Of all conduction disturbances before procedure, a pre-existing RBBB was strongly associated with a relevantly higher pacemaker rate (50.0% vs. 11.3% (p&amp;lt;0.001), HR 7.88 (IQR 2.73/22.74; p&amp;lt;0.001)). Furthermore, more severe leaflet calcification (p=0.049), a deeper implantation depth (6.0 (5.0/6.5) vs. 5.0 (4.0/60.), p=0.042), larger annular dimensions (perimeter 79.7 (75.2/87.7) 76.8 (71.9/80.7), vs. p=0.047) and prostheses sizes (Evolut 34 vs. smaller sizes 28.1 vs. 12.5%, p=0.053), higher BNP (547 (314/1488) vs. 396 (208/856)), p=0.039 and body weight (78.0 (71.3/90.0) vs. 73.0 (63.5/84.5), p=0.030) were attributed to a higher pacemaker rate. Conclusions In our retrospective database we demonstrated that a contemporary implantation protocol enabling higher implantation position leads to a significant reduction in pacemaker rate, even in the high-risk collective of patients with pre-existing RBBB (58.3 vs. 15.2%, p=0.002 compared to 33.3 vs. 6.3%, p=0.081).

Cusp-overlap technique to reduce permanent pacemaker implantation rate after transcatheter aortic valve implantation

Abstract Background Persistent conduction disturbances requiring permanent pacemaker (PPM) implantation are one of the most common complications after Transcatheter Aortic Valve Implantation (TAVI). Cusp-Overlap Technique (COT) is a novel approach for self-expandable valve implantation to minimize the rate of procedural complications, mainly PPM implantation. Purpose To determine if the COT during TAVI with self-expandable valves leads to a reduction of PPM implantation rate in the real-world setting. Methods A retrospective analysis of consecutive patients undergoing TAVI between January 2020 and November 2023 in one high-volume tertiary care center in Portugal was conducted. Two groups were defined, the COT group and the control group based on the fluoroscopic approach. A baseline comparison between the 2 groups was made using independent-samples t-test and chi-square analysis to determine if there was a difference between the prevalence of known risk factors for PPM implantation after TAVI. Afterwards, chi-square analysis was used to determine if COT led to a reduction in the PPM implantation rate. Results Of the 539 completed procedures in this timeframe, 289 were excluded due to previous pacemaker implantation, use of a valve not amenable to COT or valve-in-valve implantation. COT was used in 57.6% of eligible cases. Baseline comparison did not show a significant difference in the prevalence of several known risk factors for PPM implantation, including complete right bundle branch block, atrio-ventricular block, calcium score, aortic ring dimensions and pre/post-dilation. PPM implantation after TAVI was required in 31.6% of cases. In the COT group the PPM implantation rate was 22.9% and in the control group 43.4%. Chi-square analysis showed a very statistically significant difference between the 2 analyzed groups (p-value = 0.001). Conclusion PPM implantation remains a frequent complication of TAVI. However, this study showed that the utilization of COT leads to a reduction of the PPM implantation rate.

Initial Findings Concerning the Latest Self-Expandable Evolut FX Valve: A Report Using OCEAN-TAVI Registry Data

Data concerning the clinical effect of the latest-generation self-expandable transcatheter heart valve (Evolut FX) remain limited. We aimed to assess the in-hospital outcomes of 3 bioprosthetic valves (Evolut EPO, PRO+, and FX). We analyzed data from a Japanese multicenter registry involving 634 consecutive patients who underwent transcatheter aortic valve replacement with Evolut FX up until October 2023. Patients who underwent transcatheter aortic valve replacement with Evolut EPO between 2018 and 2020 (n = 1,128), and those with Evolut EPO+ between 2020 and 2023 (n = 1,696) served as the control groups. The exclusion criteria comprised patients on dialysis with a history of infective endocarditis or with insufficient data. Unmatched comparisons among the 3 valves were conducted, followed by a propensity score-matched comparison between Evolut EPO+ and FX. In the unmatched cohort, among the Evolut EPO, PRO+, and FX groups, all vascular complications (7.8% vs 5.2% vs 4.5%, respectively, p <0.01) and new pacemaker implantation rates (11.2% vs 6.1% vs 7.7%, respectively, p <0.01) differed significantly. In the propensity score-matched analysis, the rate of all bleeding events was significantly higher in the Evolut EPO+ group (11.0%) than in the FX group (7.0%) (p = 0.02), whereas all vascular complications (4.6% vs 4.6%, respectively, p = 1.00) and new pacemaker implantation (5.9% vs 7.6%, respectively, p = 0.28) rates were comparable. The incidence of stroke in the FX group was approximately half that of the EP+ group (3.7% vs 1.9%, p = 0.095), without statistical significance. In conclusion, compared with the Evolut EPO+, Evolut FX was associated with a lower incidence of in-hospital bleeding complications and may reduce the incidence of in-hospital stroke.

Machine learning for pacemaker implantation prediction after TAVI using multimodal imaging data

Pacemaker implantation (PMI) after transcatheter aortic valve implantation (TAVI) is a common complication. While computed tomography (CT) scan data are known predictors of PMI, no machine learning (ML) model integrating CT with clinical, ECG, and transthoracic echocardiography (TTE) data has been proposed. This study investigates the contribution of ML methods to predict PMI after TAVI, with a focus on the role of CT imaging data. A retrospective analysis was conducted on a cohort of 520 patients who underwent TAVI. Recursive feature elimination with SHAP values was used to select key variables from clinical, ECG, TTE, and CT data. Six ML models, including Support Vector Machines (SVM), were trained using these selected variables. The model’s performance was evaluated using AUC-ROC, F1 score, and accuracy metrics. The PMI rate was 18.8%. The best-performing model achieved an AUC-ROC of 92.1% ± 4.7, an F1 score of 71.8% ± 9.9, and an accuracy of 87.9% ± 4.7 using 22 variables, 9 of which were CT-based. Membranous septum measurements and their dynamic variations were critical predictors. Our ML model provides robust PMI predictions, enabling personalized risk assessments. The model is implemented online for broad clinical use.

The novel balloon-expandable Myval transcatheter heart valve: systematic review of aortic, mitral, tricuspid and pulmonary indications

Introduction and objectivesMyval technology represents the first balloon-expandable alternative since the Edwards system became commercially available. Despite certain controversies, its use has rapidly expanded. We aimed to gather all the available literature regarding its indications and outcomes. MethodsA comprehensive search of articles published between December 2016 and May 2024 was conducted using BioMedCentral, Google Scholar, and PubMed to evaluate the main outcomes of Myval for native aortic stenosis (AS) (meta-analysis) and off-label uses (systematic review). ResultsA total of 151 studies were identified, and 74 were included in the analysis, covering aortic (n=51), mitral (n=9), tricuspid (n=6), and pulmonary (n=8) valve positions. A meta-analysis of studies on native AS demonstrated that Myval is safe and effective, with a 30-day mortality rate of 1.3%, good hemodynamic performance, low rates of pacemaker implantation (8.8%), and ≥ moderate paravalvular regurgitation (1.3%). Compared with other contemporary devices, Myval was competitive and associated with lower rates of pacemaker implantation. In a systematic review of off-label indications, Myval was also found to be safe and effective. In bicuspid AS, pure regurgitation, and aortic valve-in-valve procedures, success rates were 100%, 92%, and 100%, respectively, with pacemaker rates of 9.9%, 22.2%, and 3%, respectively. For mitral valve-in-valve/in-ring procedures, the success rate was 96.9%, while in tricuspid and pulmonary positions, small case series reported 100% success rates for both, with minimal procedural complications. ConclusionsMyval technology is safe and effective for the treatment of native valvular disease and dysfunctional prostheses or rings in all heart valve positions, although larger scale studies are warranted.

Impact of early detection and steroid treatment on fetal ventricular heart rate and pacemaker implantation in anti-Ro/SSA positive congenital heart block.

We investigated the effects of timing of detection and transplacental fluorinated steroid treatment on ventricular heart rate (HR) and age at pacemaker implantation in fetal third-degree atrioventricular block (AVB). Twenty-five of 31 fetuses diagnosed with Ro/SSA autoantibody-positive AVB II-III at our tertiary fetal cardiology center (2000-2020) and AVB III as final feto-neonatal outcome were reviewed. AVB was detected approximately 5 weeks earlier in pregnancy if followed in a surveillance program compared to cases referred from primary care for bradycardia (20.6 [2.3] [mean (SD)] vs. 25.4 [3.2] weeks, p = 0.001). AVB detected before 24 weeks had higher HR than those detected later in gestation (63.3 [6.9] vs. 57.2 [6.9] bpm, p = 0.042), with a larger proportion having HR >60 bpm (80% vs. 33%, p = 0.041). The 17/25 cases that received treatment with fluorinated steroid were diagnosed earlier in gestation, with higher HR at diagnosis (61.7 [7.1] vs. 54.7 [6.3] bpm, p = 0.026), 1-2 weeks after diagnosis/treatment start, and before birth (65.4 [12.4] vs. 54.9 [5.7] bpm, p = 0.030) than untreated cases. Overall, 11 cases were commenced on betamimetics: three at diagnosis and eight at or after the examination made 1-2 weeks after diagnosis/treatment start, without any HR improvement. Two of 24 surviving babies were born preterm, and 4/24 received a neonatal pacemaker. Age at pacemaker implantation correlated significantly with HR before birth (Spearman R 0.57, p = 0.004), and fetuses with HR >60 bpm had a higher rate of pacemaker-free survival at three (90% vs. 40%, p = 0.018) and 12 months of age (80% vs. 13%, p = 0.002). The same trend was observed in pacemaker-free survival at 3 months of age in fluorinated steroid-treated compared to untreated cases (71% vs. 38%, ns). Our data confirm that AVB III detected earlier in gestation have a higher HR, and suggest that this higher HR can be successfully maintained to the end of gestation in cases treated with fluorinated steroids. Fetuses with HR >60 bpm before birth had a lower rate of pacemaker implantation at 3 and 12 months of age.

Clinical Outcomes of Concomitant Secondary Chordal Cutting to Surgical Myectomy in HOCM.

In patients who underwent surgical septal myectomy for hypertrophic obstructive cardiomyopathy (HOCM), additional mitral valve repair may offer additional benefits in terms of further reducing left ventricle outflow tract (LVOT) gradients, systolic anterior motion (SAM) and mitral regurgitation (MR). We performed a systematic review of the literature to evaluate the evidence of surgical myectomy with additional secondary chordal cutting in patients with HOCM. A systematic literature search in MEDLINE and EMBASE was performed until April 2024. The primary outcome studied was postoperative echocardiographic LVOT-gradient. A random effects meta-analysis of means was performed for the primary outcome. The secondary outcomes studied were postoperative residual MR-grade, 30-day new permanent pacemaker implantation, and in-hospital mortality. From 1911 unique publications, a total of 6 articles fulfilled the inclusion criteria and comprised 471 patients with a pooled mean preoperative resting LVOT gradient of 84 mmHg (95% CI: 76-91). The postoperative pooled mean LVOT-gradient was 11 mmHg (95% CI: 10 - 12) with a low heterogeneity (I2 = 44%). The residual LVOT gradient exceeding 30 mmHg was present in 9 (1%) patients. MR-grade 3 or 4 at hospital discharge was present in 7 (1%) patients. The 30-day new permanent pacemaker implantation rate was 7% and the in-hospital mortality was 0.4%. This systematic review and meta-analysis demonstrate that combining surgical septal myectomy with secondary chordal cutting can be performed safely and effectively eliminate LVOT obstruction in HOCM patients. Further studies are needed to determine the additive effectiveness of additional secondary chordal cuttings.

Improved outcomes with leadless vs. single-chamber transvenous pacemaker in haemodialysis patients.

Cardiac conduction disorders are common in haemodialysis patients, with a relatively high rate of pacemaker implantations. Pacemaker-related complications, especially lead infections and central venous stenosis, pose significant challenges in this population. This study aims to compare single-chamber leadless pacemaker to single-chamber transvenous pacemakers in terms of survival and related complications in haemodialysis patients. This retrospective study included adult haemodialysis patients who received a first single-chamber transvenous or leadless pacemaker between January 2017 and December 2020. Data were obtained from the French national REIN registry matched to the national health databases (Système National des Données de Santé). Propensity score matching was used to balance baseline characteristics. Survival and complications were compared between groups by Cox regression and by competitive risk models, respectively. One hundred and seventy-eight patients were included after propensity score matching, with 89 patients in each group. The median follow-up time was 24 (range 7-37) months. Leadless pacemakers were associated with significantly lower all-cause mortality rates compared to transvenous pacemakers [hazard ratio (HR) = 0.68, 95% confidence interval (CI) (0.47-0.99)]. Device-related infections are significantly lower with leadless pacemakers throughout the follow-up period (HR 0.43, 95% CI 0.21-0.86). Leadless pacemaker recipients also required fewer vascular access interventions [odds ratio 0.53, 95% CI (0.33-0.68)] on arteriovenous fistula. With the limitations of its observational design, this study suggests that leadless pacemakers are associated with a lower rate of complications and better survival as compared with transvenous VVI pacemakers in haemodialysis patients, supporting to consider their preferential use in this population.

Left Ventricular Outflow Tract Morphology as a Predictor of Conductance Disturbances Following Transcatheter Aortic Valve Replacement.

Conduction disturbances represent one of the most common complications following transcatheter aortic valve replacement (TAVR). We sought to investigate the role of left ventricular outflow tract (LVOT) morphology in the development of conduction disturbances following TAVR. Consecutive patients who underwent TAVR in our center were included. The ratio between the LVOT area and the aortic annulus area was calculated. Patients were then divided into 2 groups on the basis of this ratio: group 1, which included patients with an LVOT area/aortic annulus area ratio <0.9; and group 2, which included patients with an LVOT area/aortic annulus area ratio ≥0.9. The primary end point was to assess the relationship between LVOT shape and the rate of permanent pacemaker implantation following TAVR. A multivariable analysis was performed to identify predictors of permanent pacemaker implantation following TAVR. From January 2018 to December 2020, 276 patients were included. Ninety-one patients with tapered LVOT morphology were assigned to group 1 and the rest (n=185 patients), tubular LVOT or flared LVOT shape, to group 2. The mean age was 81.5±5.7 years and 57% were women. After adjusting by confounding factors, tapered morphology of the LVOT and prior right bundle-branch block were found to be independent predictors of permanent pacemaker implantation (hazard ratio [HR], 2.6 [95% CI, 1.2-5.7]; P=0.014; and HR: 4.3 [95% CI 2.4-7.6], P<0.001); at a median follow-up time of 15.5 (interquartile range, 15) months. A tapered-LVOT morphology was associated with increased risk for permanent pacemaker implantation. LVOT morphology may be an additional factor to consider when choosing prosthesis size.

Outcomes of transcatheter aortic valve implantation for native aortic valve regurgitation.

Large datasets of transcatheter aortic valve implantation (TAVI) for pure aortic valve regurgitation (PAVR) are scarce. We aimed to report procedural safety and long-term clinical events (CE) in a contemporary cohort of PAVR patients treated with new-generation devices (NGD). Patients with grade III/IV PAVR enrolled in the FRANCE-TAVI Registry were selected. The primary safety endpoint was technical success (TS) according to Valve Academic Research Consortium 3 criteria. The co-primary endpoint was defined as a composite of mortality, heart failure hospitalisation and valve reintervention at last follow-up. From 2015 to 2021, 227 individuals (64.3% males, median age 81.0 [interquartile range {IQR} 73.5-85.0] years, with EuroSCORE II 6.0% [IQR 4.0-10.9]) from 41 centres underwent TAVI with NGD, using either self-expanding (55.1%) or balloon-expandable valves (44.9%; p=0.50). TS was 85.5%, with a non-significant trend towards increased TS in high-volume activity centres. A second valve implantation (SVI) was needed in 8.8% of patients, independent of valve type (p=0.82). Device size was ≥29 mm in 73.0% of patients, post-procedure grade ≥III residual aortic regurgitation was rare (1.2%), and the permanent pacemaker implantation (PPI) rate was 36.0%. At 30 days, the incidences of mortality and reintervention were 8.4% and 3.5%, respectively. The co-primary endpoint reached 41.6% (IQR 34.4-49.6) at 1 year, increased up to 61.8% (IQR 52.4-71.2) at 4 years, and was independently predicted by TS, with a hazard ratio of 0.45 (95% confidence interval: 0.27-0.76); p=0.003. TAVI with NGD in PAVR patients is efficient and reasonably safe. Preventing the need for an SVI embodies the major technical challenge. Larger implanted valves may have limited this complication, outweighing the increased risk of PPI. Despite successful TAVI, PAVR patients experience frequent CE at long-term follow-up.

Outcomes of Valve-in-Valve (VIV) Transcatheter Aortic Valve Replacement (TAVR) after Surgical Aortic Valve Replacement with Sutureless Surgical Aortic Valve Prostheses Perceval™: A Systematic Review of Published Cases.

Background: Valve-in-Valve (VIV) transcatheter aortic valve replacement (TAVR) is a potential solution for malfunctioning surgical aortic valve prostheses, though limited data exist for its use in Perceval valves. Methods: searches were performed on PubMed and Scopus up to 31 July 2023, focusing on case reports and series addressing VIV replacement for degenerated Perceval bioprostheses. Results: Our analysis included 57 patients from 27 case reports and 6 case series. Most patients (68.4%) were women, with a mean age of 76 ± 4.4 years and a mean STS score of 6.1 ± 4.3%. Follow-up averaged 9.8 ± 8.9 months, the mean gradient reduction was 15 ± 5.9 mmHg at discharge and 13 ± 4.2 mmHg at follow-up. Complications occurred in 15.7% of patients, including atrioventricular block III in four patients (7%), major bleeding or vascular complications in two patients (3.5%), an annular rupture in two patients (3.5%), and mortality in two patients (3.5%). No coronary obstruction was reported. Balloon-expanding valves were used in 61.4% of patients, predominantly the Sapien model. In the self-expanding group (38.6%), no valve migration occurred, with a permanent pacemaker implantation rate of 9%, compared to 5.7% for balloon-expanding valves. Conclusions: VIV-TAVR using both balloon-expanding and self-expanding technologies is feasible after the implantation of Perceval valves; however, it should be performed by experienced operators with experience both in TAVR and VIV procedures.

Single-center experience with self-expanding transcatheter aortic valve system for symptomatic high-risk patients with severe aortic regurgitation: One-year outcomes.

To evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) for the treatment of aortic regurgitation (AR). From September 2019 to February 2022, 62 patients who underwent transfemoral TAVI procedure for pure, symptomatic severe AR with the VitaFlow system were enrolled in the current study. The outcomes were assessed according to the Valve Academic Research Consortium 3 criteria. Procedural results and clinical outcomes for 1 year were analyzed. The mean age was 71.56 ± 7.34 years and 58.1% were male. The mean Society of Thoracic Surgeons score was 5.44 ± 3.22%. The device success rate was 79.0%. Only one patient was converted to open surgery. The in-hospital mortality rate was 1.6%. The 1-year all-cause mortality rate was 6.5%. The new permanent pacemaker implantation rate was 29.0% in-hospital and 30.7% at 1-year follow-up. The second valve implantation rate was 14.5%. No patient developed more than moderate paravalvular leakage during follow-up. The mean ejection fraction improved from 54.05 ± 10.83% at baseline to 59.32 ± 8.70% (p < 0.001 compared with baseline) at 12 months. Left ventricular end-diastolic diameter decreased from 61.62 ± 5.58 mm at baseline to 55.20 ± 4.51 mm (p < 0.001 compared with the baseline) at 12 months. Transfemoral TAVI procedure shows efficacy in treating patients with severe pure native AR. The safety is improved with the development of the VitaFlow system.

Multicenter, propensity-weighted comparison of stented, rapid-deployment and new-generation aortic valves

BackgroundConventional stented, rapid deployment and new-generation stented valves are now available for surgical aortic valve replacement (SAVR). New-generation devices feature advanced tissue treatment for theoretical prolonged durability and a new stent design able to expand in case of future transcatheter Valve-in-Valve. Aim of this retrospective, multicenter, propensity-weighted study was to compare early clinical and hemodynamic outcomes of these three different bioprostheses. MethodsWe analyzed data of 2589 patients from two national multicenter registries and one Institutional database. Study devices were Magna Ease, Intuity/Intuity Elite and Inspiris Resilia (Edwards Lifesciences, Irvine, CA, USA) and were implanted in 296 (11.4 %), 1688 (65.2 %) and 605 (23.4 %) patients, respectively. A propensity score weighting approach was employed. ResultsIn isolated SAVR, aortic cross clamp (ACC) time was shorter for Intuity (Magna Ease: 87, Intuity: 55, Inspiris: 70 min; Magna Ease vs. Intuity: p < 0.001; Inspiris vs. Intuity: p < 0.001). Overall mortality was 2 %, 1.7 % and 0.5 % in Magna Ease, Intuity and Inspiris groups, respectively (Magna Ease vs. Intuity: p = 0.476; Inspiris vs. Intuity: p = 0.395); permanent pace-maker implantation rate was lower for Inspiris (Magna Ease: 6 %, Intuity: 6 %, Inspiris: 2 %; Magna Ease vs. Intuity: p = 0.679; Inspiris vs. Intuity: p < 0.001). Median mean gradients were 13, 10 and 10 mmHg for Magna Ease, Intuity and Inspiris, respectively (Magna Ease vs. Intuity: p < 0.001; Inspiris vs. Intuity: p = 0.13). ConclusionsAll study devices provide excellent early clinical and hemodynamic outcomes. Inspiris shows low rates of permanent pace-maker implantation and its transaortic gradients are similar to rapid-deployment valves and lower than Magna Ease.