Polsani, Venkateshwar

AbstractIntroductionPercutaneous left atrial appendage occlusion (LAAO) is traditionally performed under general anesthesia with trans‐esophageal echocardiography guidance. Intracardiac echo (ICE)‐guided LAAO closure is increasing in clinical use. The ICE catheter is crossed into LA via interatrial septum (IAS) after the septum is dilated with LAAO delivery sheath. This step can be time‐consuming and requires significant ICE catheter manipulation, which increases the risk of cardiac perforation. Pre‐emptive septal balloon dilation can potentially help with ICE advancement in the LA. We sought to evaluate the effect of pre‐dilation of the IAS with an 8 mm balloon on the ease of crossing the ICE catheter, fluoroscopy time for crossing, and overall procedure time.MethodsThe Piedmont LAAO registry was used to identify consecutive patients who underwent LAAO. The initial 25 patients in whom balloon dilation of the IAS was performed served as the experimental cohort, and the 25 consecutive patients before that in whom balloon dilation was not performed served as controls. In the experimental group, after a trans‐septal puncture, the sheath was retracted to the right atrium with a guidewire still in the LA. An 8 × 40 mm Evercoss™ over the wire balloon was inflated across the IAS. The ICE catheter was then crossed into the LA using the fluoroscopic landmark of the guide wire and the ICE imaging. The sheath was then advanced along the ICE catheter via the transseptal puncture (TSP) and the procedure continued. Follow‐up compputed tomography imaging was obtained at 4–8 weeks.ResultsEach group consisted of 25 patients. There were no significant differences in baseline characteristics. All procedures were performed successfully under conscious sedation and ICE guidance. There was a significant reduction in the overall procedure time, fluoroscopy time, and time for transseptal puncture to ICE in LA. There was no difference in the size of the acute residual interatrial shunt, as measured via ICE, or the size and presence of iatrogenic ASD at follow‐up.ConclusionBalloon dilation of TSP is safe and is associated with increased efficiency in ICE‐guided LAAO procedures.

Background: Percutaneous left atrial appendage occlusion (LAAO) is traditionally performed under general anesthesia with trans-esophageal echocardiography guidance. Intracardiac echo (ICE) guided LAAO closure is increasing in clinical use. The ICE catheter is crossed into LA via interatrial septum (IAS) after the septum is dilated with LAAO delivery sheath. This step can be time-consuming and requires significant ICE catheter manipulation increasing the risk of cardiac perforation. Pre-emptive septal balloon dilation can potentially help with the advancement of ICE in LA. Objective: Evaluate the effect of pre-dilation of IAS with an 8 mm balloon on ease of crossing the ICE catheter, fluoroscopy time for crossing, and overall procedure time. Methods: The Piedmont LAAO registry was used to identify consecutive patients undergoing LAAO. The initial 25 patients where balloon dilation of IAS was performed served as the experimental cohort, and the 25 consecutive patients prior to that in whom balloon dilation was not performed, served as controls. For the experimental group, after a trans-septal puncture, the sheath was retracted to the right atrium with guide wire still in the LA. An 8x40 mm Evercoss™ over the wire balloon was inflated across the IAS. The ICE catheter was then crossed into the LA using the fluoroscopic landmark of the guide wire and the ICE imaging. The sheath was then advanced along the ICE catheter via the transseptal puncture (TSP) and the procedure continued. Follow up CT imaging was obtained in 4-8 weeks. Results: Each group included 25 patients. There were no significant differences in baseline characteristics. All procedures were performed successfully with the use of conscious sedation and ICE guidance. There was a significant reduction in overall procedure time, fluoroscopy time, and time for trans-septal puncture to ICE in LA. There was no difference in the size of the acute residual interatrial shunt as measured via ICE or size and presence of iatrogenic ASD at follow up. Conclusion: Balloon dilation of TSP is safe and associated with increased efficiencies in ICE guided LAAO procedures.

Importance In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm 2 vs 1.8 [0.6] cm 2 ; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.