Background Transcatheter aortic valve replacement (TAVR)‐in‐TAVR is a possible treatment for transcatheter heart valve ( THV ) degeneration. However, the displaced leaflets of the first THV will create a risk plane ( RP ) under which the passage of a coronary catheter will be impossible. The aim of our study was to evaluate the potential risk of impaired coronary access ( CA ) after TAVR ‐in‐ TAVR . Methods and Results We prospectively performed coronary angiography after TAVR with different THV s in 137 consecutive patients, looking where the catheter crossed the valve frame. If coronary cannulation was achieved from below the RP , the distance between valve frame and aortic wall was measured by aortic angiography. CA after TAVR ‐in‐ TAVR was defined as feasible if the catheter passed above the RP , as theoretically feasible if passed under the RP with valve‐to‐aorta distance >2 mm, and as unfeasible if passed under the RP with valve‐to‐aorta distance ≤2 mm. Seventy‐two patients (53%) received a Sapien 3 THV, 26 (19%) received an Evolut Pro/R THV, and 39 (28%) received an Acurate Neo THV . CA after TAVR ‐in‐ TAVR was considered feasible in 40.9% (68.1%, 19.2%, and 5.1%, respectively; P <0.001), theoretically feasible in 27.7% (8.3%, 42.3%, and 53.8%, respectively; P <0.001), and unfeasible in 31.4% (23.6%, 38.5%, and 41.1%, respectively; P =0.116). Independent predictors of impaired CA after TAVR ‐in‐ TAVR were female sex (odds ratio [OR], 3.99; 95% CI , 1.07–14.86; P =0.040), sinotubular junction diameter (OR, 0.62; 95% CI , 0.48–0.80; P <0.001), and implantation of a supra‐annular THV (OR, 6.61; 95% CI , 1.98–22.03; P =0.002). Conclusions CA after TAVR ‐in‐ TAVR might be unfeasible in >30% of patients currently treated with TAVR . Patients with a small sinotubular junction and those who received a supra‐annular THV are at highest risk of potential CA impairment with TAVR ‐in‐ TAVR .
Background: Coronary access (CA) after transcatheter aortic valve replacement (TAVR) with supra-annular transcatheter heart valves (THV) can be challenging. Specific Evolut R/Pro and Acurate Neo THVs orientations are associated with reduced neo-commissure overlap with coronary ostia, while SAPIEN 3 THV cannot be oriented. With the ALIGN-ACCESS study (TAVR With Commissural Alignment Followed by Coronary Access), we investigated the impact of commissural alignment on the feasibility of CA after TAVR. Methods: We performed coronary angiography after TAVR with intra-annular SAPIEN 3, supra-annular Evolut R/Pro, and Acurate Neo THVs in 206 patients. Evolut THVs were implanted aiming for commissure alignment. Alignment of Acurate Neo was retrospectively assessed in 36, intentionally attempted in 26 cases. The primary end point was the rate of unfeasible and nonselective CA after TAVR. Results: Thirty-eight percent of patients received SAPIEN 3, 31.1% Evolut Pro/R, 30.1% Acurate Neo THV. Final valve orientation was favorable to commissural alignment in 85.9% of Evolut and 69.4% of Acurate Neo cases (with intentional alignment successful in 88.5%). Selective CA was higher for SAPIEN 3 than for aligned and misaligned supra-annular THVs (95% versus 71% versus 46%, P <0.001). Cannulation of at least one coronary was unfeasible with 11% misaligned supra-annular, 3% aligned supra-annular, and 0% SAPIEN 3 THVs. Independent predictors of unfeasible/nonselective CA were implantation of a misaligned supra-annular THV (odds ratio, 4.59 [95% CI, 1.81–11.61]; P <0.01), sinus of Valsalva height (odds ratio, 0.83 [95% CI, 0.7–0.98]; P =0.03), and THV–sinus of Valsalva relation (odds ratio, 1.06 [95% CI, 1.02–1.1]; P <0.01). Conclusions: Commissural alignment improves the rate of selective CA after TAVR with supra-annular THVs. Nevertheless, aligned supra-annular THVs carry higher risk of unfeasible/nonselective CA than SAPIEN 3. Patients with a misaligned supra-annular THV, low sinus of Valsalva, and higher THV–sinus of Valsalva relation are at highest risk of impaired CA after TAVR.
Background: Conduction disturbances after transcatheter aortic valve replacement (TAVR) are often transient. Limited data exist on anatomic factors predisposing to pacemaker dependency after TAVR. We sought to assess the rate and the possible predictors of pacemaker dependency after TAVR. Methods: Consecutive patients undergoing pacemaker implantation up to 30 days after TAVR between May 2014 and September 2019 were included. Baseline electrocardiographic, computed tomography, and procedural characteristics were collected, including valve implantation depth and membranous septum length, an anatomic surrogate of the distance between the aortic annulus and the His bundle. Pacemaker dependency at 30 days and 1 year and all-cause mortality during follow-up were evaluated. Results: Of 728 TAVR patients, 112 (53.5% men; median age, 81 years) underwent pacemaker implantation after TAVR. Of these, 44.6% (50 of 112) were pacemaker dependent at 30 days and 46.7% (36 of 77) at 1 year. By multivariate analysis, independent predictors of 30-day pacemaker dependency included left ventricular outflow tract calcifications under the left coronary cusp (odds ratio, 5.69 [95% CI, 1.45–22.31]; P =0.013) and a difference between membranous septum length and implantation depth (ΔMSID) ≥3 mm (odds ratio, 7.58 [95% CI, 2.07–27.78]; P =0.002). Conversely, membranous septum length and implantation depth alone were not associated with pacemaker dependency (odds ratio, 0.79 [95% CI, 0.60–1.05]; P =0.11 and odds ratio, 1.11 [95% CI, 0.99–1.24]; P =0.08). At a median follow-up of 28.1 (11.7–48.6) months, pacemaker-dependent patients did not show a worse survival ( P =0.26). Conclusions: Less than half of the patients undergoing pacemaker implantation after TAVR are pacemaker-dependent at midterm follow-up. ΔMSID ≥3 mm and the presence of left ventricular outflow tract calcifications under the left coronary cusp, but not membranous septum length nor implantation depth alone, are predictive of long-term pacemaker dependency after TAVR, thus influencing device selection and programming.
Aims:The aim of this study was to evaluate 30-day safety and efficacy outcomes of transcatheter aortic valve implantation (TAVI) performed with the SAPIEN 3 Ultra system. Methods and results:The S3U registry is a physician-led, post-approval, multicentre, observational registry of transfemoral TAVI with the SAPIEN 3 Ultra. New features include an improved sealing skirt, a 14 Fr expandable sheath and a new delivery catheter. Overall, 139 consecutive patients at nine participating centres were enrolled. Mean age was 81.4±8.3 years, average STS score 3.8±2.4%. The vast majority (97.2%) underwent TAVI with local anaesthesia (28.8%) or conscious sedation (68.3%). Balloon predilatation was performed in 30 patients (21.6%), post-dilatation in three (2.2%). In-hospital, there were no cases of death, stroke, or conversion to open heart surgery. Major vascular complications occurred in three patients (2.2%), as well as major or life-threatening bleedings in three patients (2.2%). There were two moderate (1.4%) and no moderate/severe paravalvular leaks. Median length of stay after TAVI was three days (IQR 3-5 days). At 30 days, there were no deaths, MI, or strokes, and the incidence of new permanent pacemaker implantation was 4.4%.Conclusions: This first multicentre international experience of transfemoral TAVI with the SAPIEN 3 Ultra transcatheter heart valve shows good in-hospital and 30-day clinical outcomes.
Background Incidence of coronary access (CA) after transcatheter aortic valve replacement (TAVR) at long‐term follow‐up remains unknown. CA and percutaneous coronary intervention (PCI) after TAVR might present technical challenges, particularly with supra‐annular devices. Methods Patients undergoing CA after being treated with TAVR at our institution were included in the study. Coronary interventions for coronary obstruction during TAVR procedure were excluded. Incidence, feasibility and outcomes of CA after TAVR were analyzed. Results Out of 912 patients aged 80 ± 7 years treated with TAVR at our institution between 2007 and 2018, 48 (5.3%) underwent CA at a median follow up of 769 [363–1,471] days. Twenty‐one had received a SAPIEN XT, 15 a SAPIEN 3, 6 Corevalve, 2 Evolut Pro, 2 JenaValve, and 2 Lotus valve. PCI was indicated in 26 (54%) cases. Seventeen (35%) procedures were performed for acute coronary syndromes (ACS). Independent predictors of CA after TAVR were younger age, previous PCI, and CABG. CA of both vessels was feasible in all patients with an intra‐annular device, while the right coronary artery was not engaged in two patients with a supra‐annular valve. PCI was successful in all but one case. All‐cause mortality was similar between patients needing CA for ACS and those who had other clinical indications. Conclusions In this high‐risk AS population, incidence of CA after TAVR at long‐term follow‐up was rather low. CA and PCI were safe and successful in most cases, with a lower rate of selective CA for supra‐annular devices.
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