No abstract

TMVI using the CardiAQ™ device via a transapical approach is feasible and effective.

BackgroundOpen heart surgery is associated with high occurrence of atrial fibrillation (AF), subsequently increasing the risk of post-operative ischemic stroke. Concomitant with open heart surgery, a cardiac ablation procedure is commonly performed in patients with known AF, often followed by left atrial appendage closure with surgery (LAACS). However, the protective effect of LAACS on the risk of cerebral ischemia following cardiac surgery remains controversial. We have studied whether LAACS in addition to open heart surgery protects against post-operative ischemic brain injury regardless of a previous AF diagnosis.MethodsOne hundred eighty-seven patients scheduled for open heart surgery were enrolled in a prospective, open-label clinical trial and randomized to concomitant LAACS vs. standard care. Randomization was stratified by usage of oral anticoagulation (OAC) planned to last at least 3 months after surgery. The primary endpoint was a composite of post-operative symptomatic ischemic stroke, transient ischemic attack or imaging findings of silent cerebral ischemic (SCI) lesions.ResultsDuring a mean follow-up of 3.7 years, 14 (16%) primary events occurred among patients receiving standard surgery vs. 5 (5%) in the group randomized to additional LAACS (hazard ratio 0.3; 95% CI: 0.1–0.8, p = 0.02). In per protocol analysis (n = 141), 14 (18%) primary events occurred in the control group vs. 4 (6%) in the LAACS group (hazard ratio 0.3; 95% CI: 0.1–1.0, p = 0.05).ConclusionsIn a real-world setting, LAACS in addition to elective open-heart surgery was associated with lower risk of post-operative ischemic brain injury. The protective effect was not conditional on AF/OAC status at baseline.Trial registrationLAACS study, clinicaltrials.gov NCT02378116, March 4th 2015, retrospectively registered.Electronic supplementary materialThe online version of this article (10.1186/s13019-018-0740-7) contains supplementary material, which is available to authorized users.

ImportanceIn 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.ObjectiveTo 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 ParticipantsSURTAVI 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.InterventionPatients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis.Main Outcomes and MeasuresThe 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.ResultsA 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] cm2 vs 1.8 [0.6] cm2; 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 RelevanceAmong 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.

No abstract

In this initial experience, the axillarian bareback approach technique allowed a safe and successful TAVI implant in a subgroup of patients with a high risk of procedural complications due to the presence of a patent LIMA-LAD or vessels of small caliber. Considering the increasing number of patients referred for TAVI, in the next future the axillarian bareback approach could represent a safer alternative to direct cannulation in patients with severe aortic stenosis with no other access options.

BackgroundIncident atrial fibrillation (AF) is reported in 10%–65% of patients without previous AF diagnosis after open heart surgery. The risk of late AF recurrence after a postoperative AF onset is unclear, and it is controversial whether AF limited to the postoperative period should elicit oral anticoagulation (OAC) therapy. The primary objective of this study was to evaluate the long-term recurrence of AF in patients developing new-onset peri-procedural AF.Patients and methodsPatients (n=189) with available baseline and follow-up data included in Left Atrial Appendage Closure with Surgery trial were coded for known AF at baseline and for postoperative first-time AF diagnosis. AF occurrence was classified as follows: peri-procedural ≤7 days postoperatively, early >7 days but ≤3 months and late >3 months. Patients with no AF recurrence registered during follow-up were invited to undergo Holter monitoring.ResultsA total of 163 (86.2%) patients had no history of AF. Among these, 80 (49.1%) developed new-onset peri-procedural AF. After a mean follow-up of 3.7±1.6 years, late AF occurred in 35 of the 80 (43.8%) patients who developed peri-procedural AF and in 6 additional patients (7.2%) who remained in sinus rhythm until discharge (hazard ratio [HR] 9.3, 95% CI 3.8–22.4, p<0.001). Patients with peri-procedural AF and early AF had 12.24 times higher risk of late AF (95% CI 4.76–31.45, p<0.001) as compared to the group with no postoperative AF.ConclusionNew-onset of AF after open heart surgery has a high rate of recurrence and should not be regarded as a self-limiting phenomenon secondary to surgery.

No abstract