Background: The best management of stable coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is still unclear due to the marked inconsistency of the available evidence. Methods: The REVASC-TAVI registry (Management of Myocardial Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation With Coronary Artery Disease) collected data from 30 centers worldwide on patients undergoing TAVI who had significant, stable CAD at preprocedural work-up. For the purposes of this analysis, patients with either complete or incomplete myocardial revascularization were compared in a propensity score matched analysis, to take into account of baseline confounders. The primary and co-primary outcomes were all-cause death and the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure, respectively, at 2 years. Results: Among 2407 patients enrolled, 675 pairs of patients achieving complete or incomplete myocardial revascularization were matched. The primary (21.6% versus 18.2%, hazard ratio‚ 0.88 [95% CI, 0.66–1.18]; P =0.38) and co-primary composite (29.0% versus 27.1%, hazard ratio‚ 0.97 [95% CI, 0.76–1.24]; P =0.83) outcome did not differ between patients achieving complete or incomplete myocardial revascularization, respectively. These results were consistent across different prespecified subgroups of patients (< or >75 years of age, Society of Thoracic Surgeons score > or or 0.10). Conclusions: The present analysis of the REVASC-TAVI registry showed that, among TAVI patients with significant stable CAD found during the TAVI work-up, completeness of myocardial revascularization achieved either staged or concomitantly with TAVI was similar to a strategy of incomplete revascularization in reducing the risk of all cause death, as well as the risk of death, stroke, myocardial infarction, and rehospitalization for heart failure at 2 years, regardless of the clinical and anatomical situations.
Background/Objectives: To date, data regarding the characteristics and management of obstructive, stable coronary artery disease (CAD) encountered in patients undergoing transcatheter aortic valve implantation (TAVI) are sparse. The aim of the study was to analyze granular details, treatment, and outcomes of patients undergoing TAVI with obstructive, stable CAD from real-world practice. Methods: REVASC-TAVI (Management of myocardial REVASCularization in patients undergoing Transcatheter Aortic Valve Implantation with coronary artery disease) is an investigator-initiated, multicenter registry, which collected data from patients undergoing TAVI with obstructive stable CAD found during the pre-TAVI work-up. Results: A total of 2025 patients from 30 centers worldwide with complete follow-up were included in the registry. Most patients had single-vessel CAD (56.1%). An involvement of proximal coronary tracts was detected in 62.5% of cases, with 12.0% of patients having CAD in left main (LM). Most patients received percutaneous coronary intervention (PCI) (n = 1617, 79.9%), especially those with proximal CAD (90.4%). At 2 years, the rates of all-cause death [Kaplan–Meier (KM) estimates 20.1% vs. 18.8%, plog-rank = 0.86] and of the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure (KM estimates 29.7% vs. 27.5%, plog-rank = 0.82) did not differ between patients undergoing PCI and those who were not. Conclusions: Patients undergoing TAVI with obstructive CAD more commonly had a single-vessel disease and an involvement of proximal coronary tracts. They were commonly treated with PCI, with similar outcomes compared to those treated conservatively.
Patients with severe mitral regurgitation (MR), atrial fibrillation (AF), and contraindications to long-term anticoagulation often require multiple interventions. The feasibility of combining mitral transcatheter edge-to-edge repair, left atrial appendage closure (LAAC), and AF ablation in a single session is unknown. A 78-year-old woman with dilated cardiomyopathy, severe functional MR, and high-burden paroxysmal AF underwent a single-session procedure including pulsed-field AF ablation, mitral transcatheter edge-to-edge repair, and LAAC. Pulmonary veins were isolated, a MitraClip was deployed at A2-P2 with marked MR reduction, and a Watchman device was successfully implanted. The patient remained hemodynamically stable without complications, and follow-up confirmed effective MR reduction, complete LAAC, and maintenance of sinus rhythm. This case demonstrates the feasibility and safety of a combined single-session approach in selected high-risk patients. A one-stop procedure can simultaneously address valvular disease, rhythm control, and stroke prevention. Multidisciplinary planning and operator expertise are essential for procedural success.
Background Evidence regarding sex-related differences in response to transcatheter aortic valve implantation according to the valve type is lacking. This study sought to evaluate the impact of sex on the treatment effect of Evolut-PRO/PRO+ (PRO) or Sapien 3 Ultra (ULTRA) devices on clinical outcomes. Methods Comparative Analysis of Evolut PRO vs Sapien 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation (OPERA-TAVI) is a multicenter multinational registry including patients undergoing latest-iteration PRO or ULTRA implantation. Overall, 1174 out of 1897 patients were matched based on valve type and compared according to sex, while 470 males and 630 females were matched and compared according to valve type. Thirty-day and 1-year outcomes were evaluated. Results In both PRO and ULTRA group, males had a higher comorbidity burden, while females had smaller aortic root. Both 30-day (device success [DS], early safety outcome, permanent pacemaker implantation [PPI], patient-prosthesis mismatch [PPM], paravalvular regurgitation [PVR], bleedings, vascular complications, and all-cause death) and 1-year outcomes (all-cause death, stroke and heart failure hospitalization) did not differ according to sex in both valve groups. However, male sex decreased the likelihood of 30-day DS with ULTRA versus PRO (p for interaction 0.047). A higher risk of 30-day PPI and 1-year stroke, and a lower risk of PPM was observed in PRO versus ULTRA, regardless of sex. No other differences were noted. Conclusions Sex did not modify the treatment effect of PRO versus ULTRA on clinical outcomes, with the exception of 30-day DS that was decreased in males (versus females) receiving ULTRA (versus PRO).
Background. The Lambre is a plug occluder for left atrial appendage closure (LAAC) in patients with atrial fibrillation (AF), but direct comparisons of the most used Watchman FLX and Lambre devices are lacking. Objectives. To compare the safety and efficacy of Lambre and the well-established Watchman FLX occluder for left atrial appendage (LAA) closure Methods. Between January 2023 and April 2025, a cohort of 253 consecutive patients who underwent LAAC with Lambre or Watchman FLX at Umberto I Hospital of Siracusa were included. The primary safety endpoint included major peri-procedural complications while the primary efficacy endpoint included all cause stroke, cardiovascular/unexplained death, systemic embolism and bleedings at a mean follow up of 12 months. 1:1 propensity score matching (PSM) was performed. Results. After PSM, 152 patients were included: Lambre group (n=76) and Watchman FLX group (n=76). The mean CHA2DS2-VASc score was 4.5 ± 1.3 (Lambre) vs. 4.5 ± 1.4( Watchman FLX), p=0.97; and the HAS-BLED score was 2.7 ± 0.9 vs. 2.7± 0.8, p=0.97. At a mean follow-up of 12 months, the primary efficacy endpoint (14.9% vs. 12.5%; HR, 1.57; 95% CI, 0.52–4.72; P = 0.77) and the primary safety endpoint (3.9% vs. 2.6%; HR, 1.51; CI 0.25-9.03; P=1) were similar between groups. Conclusions. LAAC with the Lambre device has demonstrated similar efficacy and safety to the Watchman devices. In a high-volume center, experienced operators, using both singleand double-element devices, can adopt a customized strategy based on each patient’s anatomy and achieve 100% successful left atrial closure.