Citations

ABSTRACT Background Valve‐in‐valve transcatheter aortic valve replacement (ViV‐TAVR) is increasingly used to treat structural valve degeneration. Permanent pacemaker implantation (PPI) following TAVR is associated with increased morbidity and mortality, yet predictors specific to ViV‐TAVR remain poorly defined. Objective To identify clinical and procedural predictors of PPI in patients undergoing ViV‐TAVR. Methods We conducted a retrospective observational study of consecutive ViV‐TAVR cases at the Mayo Clinic from 2012 to 2022. Clinical, ECG, procedural data and fluoroscopic measurements were analyzed, and propensity score matching was used to adjust for confounding. Predictors of PPI were identified using multivariable logistic regression. Results Among 261 patients, 24 (9.2%) underwent PPI. Balloon‐expandable valves were used in 66.7% and self‐expanding valves in 33.3%. Predictors of PPI included Preprocedural bifascicular block (OR 12.15, 95% CI: 2.52–68.89, p = 0.003), greater septal implantation depth (OR 1.29, 95% CI: 1.04–1.65, p = 0.019), and post‐procedural new left (OR 23.56, 95% CI: 4.91–48.52, p = 0.0004) and right bundle branch blocks (OR 24.4, 95% CI: 3.82–30.51, p = 0.001). Aortic regurgitation as the mechanism of prosthetic valve failure was associated with reduced PPI odds (OR 0.28, 95% CI: 0.10–0.76, p = 0.014). Pacing requirement—defined as > 90% ventricular pacing—increased from 25% at 3 months to 56.25% at 12 months. At a median follow‐up of 962.5 days (IQR 481.5–1555.3), adjusted mortality was significantly higher in the PPI group (aOR 9.4, 95% CI: 1.9–60.4, p = 0.028). Conclusion Bifascicular block, greater septal depth, and new bundle branch blocks predict PPI post‐ViV‐TAVR, while aortic regurgitation appears protective. Risk stratification and procedural planning are critical.

Background/Objectives: Transcatheter aortic valve replacement (TAVR) has been introduced as an optimal treatment for patients with severe aortic stenosis, offering a minimally invasive alternative to surgical aortic valve replacement. Predicting these outcomes following TAVR is crucial. Artificial intelligence (AI) has emerged as a promising tool for improving post-TAVR outcome prediction. In this systematic review and meta-analysis, we aim to summarize the current evidence on utilizing AI in predicting post-TAVR outcomes. Methods: A comprehensive search was conducted to evaluate the studies focused on TAVR that applied AI methods for risk stratification. We assessed various ML algorithms, including random forests, neural networks, extreme gradient boosting, and support vector machines. Model performance metrics—recall, area under the curve (AUC), and accuracy—were collected with 95% confidence intervals (CIs). A random-effects meta-analysis was conducted to pool effect estimates. Results: We included 43 studies evaluating 366,269 patients (mean age 80 ± 8.25; 52.9% men) following TAVR. Meta-analyses for AI model performances demonstrated the following results: all-cause mortality (AUC = 0.78 (0.74–0.82), accuracy = 0.81 (0.69–0.89), and recall = 0.90 (0.70–0.97); permanent pacemaker implantation or new left bundle branch block (AUC = 0.75 (0.68–0.82), accuracy = 0.73 (0.59–0.84), and recall = 0.87 (0.50–0.98)); valve-related dysfunction (AUC = 0.73 (0.62–0.84), accuracy = 0.79 (0.57–0.91), and recall = 0.54 (0.26–0.80)); and major adverse cardiovascular events (AUC = 0.79 (0.67–0.92)). Subgroup analyses based on the model development approaches indicated that models incorporating baseline clinical data, imaging, and biomarker information enhanced predictive performance. Conclusions: AI-based risk prediction for TAVR complications has demonstrated promising performance. However, it is necessary to evaluate the efficiency of the aforementioned models in external validation datasets.

Background Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) is increasingly used to treat structural valve degeneration. Permanent pacemaker implantation (PPI) following TAVR is associated with increased morbidity and mortality, yet predictors specific to ViV-TAVR remain poorly defined. Objective To identify clinical and procedural predictors of PPI in patients undergoing ViV-TAVR. Methods We conducted a retrospective observational study of consecutive ViV-TAVR cases at the Mayo Clinic from 2012 to 2022. Clinical, ECG, procedural data and fluoroscopic measurements were analyzed, and propensity score matching was used to adjust for confounding. Predictors of PPI were identified using multivariable logistic regression. Results Among 261 patients, 24 (9.2%) required PPI. Balloon-expandable valves were used in 66.7% and self-expanding valves in 33.3%. Predictors of PPI included pre-procedural bifascicular block (OR 12.15, 95% CI: 2.52–68.89, p=0.003), greater septal implantation depth (OR 1.29, 95% CI: 1.04–1.65, p=0.019), and post-procedural new left (OR 23.56, 95% CI: 4.91–48.52, p=0.0004) and right bundle branch blocks (OR 24.4, 95% CI: 3.82–30.51, p=0.001). Aortic regurgitation as the mechanism of prosthetic valve failure was associated with reduced PPI odds (OR 0.28, 95% CI: 0.10–0.76, p=0.014). Pacing requirement—defined as >90% ventricular pacing—increased from 25% at 3 months to 56.25% at 12 months. At a median follow-up of 962.5 days (IQR 481.5–1555.3), adjusted mortality was significantly higher in the PPI group (aOR 9.4, 95% CI: 1.9–60.4, p=0.028). Conclusion Bifascicular block, greater septal depth, and new bundle branch blocks predict PPI post-ViV-TAVR, while aortic regurgitation appears protective. Risk stratification and procedural planning are critical.

ABSTRACT Background This study aims to assess how Watchman FLX (Boston Scientific) and Amplatzer Amulet (Abbott) devices for left atrial appendage occlusion (LAAO) impact the flow dynamics in the LA and the risk of device‐related thrombosis (DRT). Methods Flow simulations were carried out for 12 AF patients before and after undergoing LAAO. Six patients had Watchman FLX while the other six had Amulet devices, of which three in each group had DRT. The flow parameters investigated included the LA velocities, pressure, time averaged wall shear stress (TAWSS), oscillatory shear index (OSI), and relative residence time (RRT). Low TAWSS and high OSI and RRT are generally associated with flow stasis and thrombosis. Results LA flow dynamics differed significantly between the two groups. On average, after LAAO, the Amulet patients exhibited a 25% increase in TAWSS and 24% decrease in RRT while the Watchman FLX patients exhibited, on average, a 24% decrease in TAWSS and a 23% increase in RRT. Both populations experienced an increase in LA pressure (~10% for Amulet patients and 16% for Watchman FLX patients). Increased DRT volume seems to be correlated with low TAWSS and elevated RRT. Conclusion This preliminary study suggests that the Amulet device might be associated with improved LA flow dynamics and a potentially lower incidence of DRT compared with the Watchman. However, a larger clinical study is needed to confirm these findings.

ABSTRACTBackgroundComparisons of outcomes after transcatheter aortic valve replacement with balloon‐expandable (BEV) versus self‐expanding (SEV) valves are limited.HypothesisThis study aimed to compare clinical and hemodynamic outcomes of BEV and SEV at short‐term (30 days), midterm (1 year), and long‐term (> 1 year) endpoints.MethodsPubMed, Embase, Scopus, and Cochrane Library databases were searched until July 2024 for randomized controlled trials. Random‐effect model (DerSimonian–Laird method) was used to pool the risk ratios (RR), mean differences, and 95% confidence intervals (CI).ResultsA total of 10 studies comprising 4325 patients (2295 BEV, 2030 SEV) were included. In short‐term, cardiovascular (RR: 0.56, 95% CI: 0.36–0.87) and all‐cause mortality (RR: 0.54, 95% CI: 0.35–0.81) were lower in the BEV group. Risk of moderate to severe paravalvular leak (PVL) was lower among BEV patients in short‐term (RR: 0.28, 95% CI: 0.17–0.49) and long‐term (RR: 0.28, 95% CI: 0.1–0.79). A limited number of studies showed a greater risk of clinical valve thrombosis on BEV in midterm and long‐term. The need for permanent pacemaker implantation was lower in BEV at both short‐term (RR: 0.56, 95% CI: 0.37–0.87), and midterm (RR: 0.78, 95% CI: 0.64–0.94). The SEV group had a larger effective orifice area with lower mean transvalvular pressure gradient at all endpoints.ConclusionsBEV is associated with reduced risk of clinical outcomes in short‐term; however, most differences diminish in longer evaluations, except for moderate to severe PVL, which remains elevated for SEV. SEVs had better hemodynamic results and lower risk of clinical valve thrombosis.

Background Stroke remains a concern after transcatheter aortic valve replacement (TAVR). Several studies attempted to identify correlates of stroke but there remains a need for better predictors. Objective This study aims to characterize the aortic arch to identify potential correlates of stroke after TAVR using a patient cohort that includes cases with and without stroke. Methods A retrospective analysis was performed on 52 patients who underwent TAVR at Mayo Clinic and Maria Cecilia Hospital. Of these patients, 26 had a stroke after TAVR and 26 did not (control). Anatomical characterization was performed on each patient. Patient-specific 3D digital models of the ascending aorta, aortic arch, and calcium were created for each patient. Geometrical measurements, including cross-sectional areas, volumes, tortuosity, curvature, and length of the model were recorded. Results There was no significant difference in the various area measurements between the two groups, but the aortic arch cross-sectional area ratio (cerebral ostia cross-sectional areas/arch cross-sectional area) was significantly higher in the stroke group. Additionally, there was no significant difference in tortuosity, curvature, aortic volume, and length of the aorta. Aortic valve calcium score, aorta calcium, and aortic arch type (I, II, or III) were not significantly different between the groups. The prevalence of a bovine arch (BA) configuration was significantly higher in the stroke group (46% vs 8% control, p < 0.05). Conclusion Aortic arch cross-sectional area ratio and BA variant were the most significant correlates of stroke after TAVR.

Background Recent technologies enable real‐time 3‐dimensional intracardiac echocardiography (ICE) with the advantages of 2‐dimensional ICE and imaging capabilities of transesophageal echocardiography. The purpose of this study is to evaluate the real‐world, multicenter safety and performance of a novel 3‐dimensional ICE system in a variety of cardiac interventions used in standard clinical practice. Methods This prospective, multicenter, observational, single‐arm study enrolled patients who were scheduled for an invasive cardiac procedure involving guidance with ICE and followed until discharge or ≤48 hours postprocedure. Intracardiac imaging was performed with the 3‐dimensional ICE catheter, VeriSight Pro (Philips Inc.). Fluoroscopy was used in all cases and transesophageal echocardiography was used in some cases. The primary safety end point was device‐related adverse events. The primary efficacy end point included technical success, imaging success, and clinical success. Results Between October 2021 and November 2022, 155 patients were enrolled and screened. Percutaneous interventions performed included atrial septal defect/patent foramen ovale closures, left atrial appendage occlusion, catheter ablations, and valve procedures. No adverse events were related to the device or procedure. The technical, imaging, and clinical success rates were 98.7% (95% CI, 95.4%–99.8%), 96.1% (95% CI, 91.8%–98.6%), 94.8% (95% CI, 91.8%–98.6%), respectively. Overall, the VeriSight Pro ICE image quality was assessed to be “acceptable” or greater in relation to reference image modality among 96.2% (149 of 155) of procedures. Conclusions VeriSight ICE imaging is safe and effective in the guidance of a wide variety of percutaneous cardiovascular procedures and has provided successful and high‐quality imaging of cardiac structures.

Abstract Aims Transcatheter mitral valve replacement (TMVR) has become a feasible alternative to surgical mitral valve replacement (SMVR) in selected patients at high surgical risk. The risk of valve thrombosis following SMVR and TMVR, and the optimal antithrombotic therapy following these procedures, remains uncertain. We aimed to compare the incidence of bioprosthetic mitral valve thrombosis (bMVT) after SMVR and TMVR, and the incidence of bMVT between patients on different antithrombotic regimens. Methods and results A literature search of Medline, Embase, and Cochrane Library was performed between January 2000 and August 2024. Random-effects models were used to derive pooled estimates of the incidence of bMVT in the absence of prior or active endocarditis and valve thrombosis. A total of 47 studies (6170 patients, total follow-up 9541.8 patient-years) were eligible for inclusion. The overall incidence of bMVT was 5.05 [95% confidence interval (CI) 3.18–8.01, I2 = 82%] per 100-patient-years. Subclinical bMVT was more common than clinically significant bMVT: incidence 19.11 vs. 7.91 per 100-patient-years, adjusted incidence rate ratio (aIRR) 4.62 (95% CI 1.39–15.36), P = 0.012. bMVT was numerically more common after TMVR than SMVR, but the comparison was not statistically significant: incidence 7.03 vs. 0.58 per 100-patient-years, aIRR 2.19 (95% CI 0.72–6.72), P = 0.170. Patients on vitamin-K antagonists (VKA) had a lower incidence of bMVT than patients on direct oral anticoagulants (DOAC; incidence 5.72 vs. 17.08, aIRR 0.31, 95% CI 0.13–0.73, P = 0.007). Conclusions bMVT is not uncommon, with numerically higher incidence in transcatheter compared to surgical valves, but the comparison was not statistically significant. VKAs are associated with a lower incidence of bMVT compared to DOACs.