Stepwise endo-/epicardial catheter ablation for atrial fibrillation: The Mediterranea approach.

BACKGROUND: Outcomes of catheter ablation (CA) among patients with nonparoxysmal atrial fibrillation (AF) are largely disappointing. OBJECTIVE: We sought to evaluate the feasibility, effectiveness, and safety of a single-stage stepwise endo-/epicardial approach in patients with persistent/longstanding-persistent AF. METHODS: We enrolled 25 consecutive patients with symptomatic persistent (n = 4) or longstanding-persistent (n = 21) AF and at least one prior endocardial procedure, who underwent CA using an endo-/epicardial approach. Our anatomical stepwise protocol included multiple endocardial as well as epicardial (Bachmann's bundle [BB] and ligament of Marshall ablations) components, and entailed ablation of atrial tachycardias emerging during the procedure. The primary outcome was freedom from any AF/atrial tachycardia episode after a 3-month blanking period. The secondary outcome was patients' symptom status during follow-up. RESULTS: The stepwise endo-/epicardial approach allowed sinus rhythm restoration in 72% of patients, either directly (n = 6, 24%) or after AF organization into atrial tachycardia (n = 12, 48%). BB's ablation was commonly implicated in arrhythmia termination. After a median follow-up of 266 days (interquartile range, 96 days), survival free from AF/atrial tachycardia was 88%. Antiarrhythmic drugs could be discontinued in 22 patients (88%). As compared to baseline, more patients were asymptomatic at 9-month follow-up (0% vs. 56%, p = .02). Five patients (20%) developed mild medical complications, whereas one subject (4%) had severe kidney injury requiring dialysis. CONCLUSION: A single-stage endo-/epicardial CA resulted in favorable rhythm and symptom outcomes in a cohort of patients with symptomatic persistent/longstanding-persistent AF and one or more prior endocardial procedures. Epicardial ablation of BB was commonly implicated in procedural success.

Stand-Alone Thoracoscopic Left Atrial Appendage Closure in Nonvalvular Atrial Fibrillation Patients at High Bleeding Risk.

OBJECTIVE: In nonvalvular atrial fibrillation (AF) patients at high bleeding risk, oral anticoagulants (OAC) may be contraindicated, and percutaneous left atrial appendage (LAA) closure has been advocated. However, following percutaneous procedure, either OAC or dual antiplatelet treatment is required. In this study, we present our experience in treating nonvalvular AF patients at high bleeding risk with thoracoscopic LAA closure with no subsequent antithrombotic therapy. METHODS: From April 2019 to January 2020, 20 consecutive AF patients, mean age 75.1 years, 16 (80%) males, underwent thoracoscopic LAA closure as a stand-alone procedure, using an epicardial clip device. OAC and antiplatelet therapy were contraindicated. Mean CHA2DS2-VASc score was 3.61, and the mean HAS-BLED score was 4.42. Successful LAA closure was assessed by transesophageal echocardiography. Primary endpoints were complete LAA closure (no residual LAA flow), operative complications, and all-cause mortality; secondary endpoints were 30-day and 6-month complications (death, ischemic stroke, hemorrhagic stroke, transient ischemic attack, any bleeding). Mean follow-up was 6 ± 4 months. RESULTS: Complete LAA closure was achieved in all patients. No operative clip-related complications or deaths occurred. At follow-up, freedom from postoperative complications was 95% and from any cerebrovascular events was 100%. Overall survival rate was 100%. CONCLUSIONS: In nonvalvular AF patients at high bleeding risk (HAS-BLED score >3), thoracoscopic LAA closure appears to be a valid alternative to percutaneous techniques not requiring dual antiplatelet or OAC treatment. Apparently, external LAA clipping minimizes the risk of thromboembolic events as compared with percutaneous procedures.

Root remodeling and aortic valve repair for unicuspid aortic valve.

BACKGROUND: Unicuspid aortic valve (UAV) anatomy is occasionally encountered in adolescents or young adults and not infrequently associated with aneurysm of the ascending aorta and aortic root. To manage both defects without aortic valve replacement we propose a combination of remodeling of the aortic root combined with bicuspidization of the UAV. METHODS: Between 1 December 2007 and November 2013, 25 patients (23 males; mean age, 38 ± 12 years; range, 21 to 65 years) with aortic regurgitation as a result of UAV and aortic root dilatation underwent remodeling of the aortic root and bicuspidization of the UAV. The dilated aortic root tissue was resected, leaving the wall adjacent to the normal commissure and at 180 degrees orientation and similar height for the new commissure. The graft was configured to create two symmetric tongues of graft and sutured to the remnants of the aortic root wall. The dysplastic right coronary cusp was resected, and autologous pericardial patches augmented the deficiency of cusp tissue between the left and noncoronary cusps. A suture annuloplasty was used in 20 cases. All patients were followed clinically and echocardiographically at 3, 6, and 12 months and at yearly intervals. Cumulative follow-up was 677 months (mean, 27 ± 18 months). RESULTS: No early or late death occurred. Intraoperative echocardiography revealed minimal or no aortic regurgitation in all patients; at discharge, systolic mean gradient was 6 ± 3 mm Hg. There was no bleeding or thromboembolic event during the follow-up. One patient exhibited endocarditis and underwent reoperation. Two patients experienced relevant recurrent aortic regurgitation for limited suture dehiscence between the patch and the cusp and were reoperated on between 16 and 32 months postoperatively. One patient underwent biologic valve replacement, and two valves were re-repaired. At 5 years, freedom from reoperation and aortic valve replacement was 81% and 91%, respectively. CONCLUSIONS: In the presence of UAV and aortic root dilatation, the concept of valve bicuspidization and root remodeling can be applied with satisfactory hemodynamic results. The hemodynamic function of an aortic valve preserved by this concept is good. If sufficient stability can be achieved, aortic valve replacement can be avoided in young patients with aortic regurgitation caused by UAV and root aneurysm.

LOWERing the INtensity of oral anticoaGulant Therapy in patients with bileaflet mechanical aortic valve replacement: results from the "LOWERING-IT" Trial.

BACKGROUND: Moderate anticoagulation after mechanical heart valve replacement has been proposed to reduce the risk of bleeding related to lifelong anticoagulation. However, the efficacy of such reduced antithrombotic regimens is still unknown. The present prospective open-label, single-center, randomized controlled trial aimed to evaluate the safety and feasibility of reduced oral anticoagulation after isolated mechanical aortic valve replacement. METHODS: Low-risk patients undergoing bileaflet mechanical aortic valve replacement were randomized to a low International normalized ratio (INR) target (1.5-2.5; LOW-INR group) or to the standard currently recommended INR (2.0-3.0; CONVENTIONAL-INR group) through daily coumarine oral therapy. No aspirin was added. Median follow-up was 5.6 years. The primary outcome was assessment of noninferiority of the low over the standard anticoagulation regimen on thromboembolic events. Secondary end point was the superiority of the reduced INR target strategy on bleeding events. RESULTS: We analyzed 396 patients (197 in the LOW-INR group and 199 in the CONVENTIONAL-INR group). The mean of INR was 1.94 +/- 0.21 and 2.61 +/- 0.25 in the LOW-INR and CONVENTIONAL-INR groups, respectively (P < .001). One versus three thromboembolic events occurred in the LOW-INR and CONVENTIONAL-INR, respectively, meeting the noninferiority criterion (P = .62). Total hemorrhagic events occurred in 6 patients in the LOW-INR group and in 16 patients in the CONVENTIONAL-INR group (P = .04). CONCLUSIONS: LOWERING-IT trial established that the proposed LOW-INR target is safe and feasible in low-risk patients after bileaflet aortic mechanical valve replacement. It results in similar thrombotic events and in a significant reduction of bleeding occurrence when compared to the conventional anticoagulation regimen.