A randomized prospective multicenter trial for stroke prevention by prophylactic surgical closure of the left atrial appendage in patients undergoing bioprosthetic aortic valve surgery--LAA-CLOSURE trial protocol.

Patients undergoing surgical aortic valve replacement (SAVR) are at high risk for atrial fibrillation (AF) and stroke after surgery. There is an unmet clinical need to improve stroke prevention in this patient population. The LAA-CLOSURE trial aims to assess the efficacy and safety of prophylactic surgical closure of the left atrial appendage for stroke and cardiovascular death prevention in patients undergoing bioprosthetic SAVR. This randomized, open-label, prospective multicenter trial will enroll 1,040 patients at 13 European sites. The primary endpoint is a composite of cardiovascular mortality, stroke and systemic embolism at 5 years. Secondary endpoints include cardiovascular mortality, stroke, systemic embolism, bleed fulfilling academic research consortium (BARC) criteria, hospitalization for decompensated heart failure and health economic evaluation. Sample size is based on 30% risk reduction in time to event analysis of primary endpoint. Prespecified reports include 30-day safety analysis focusing on AF occurrence and short-term outcomes and interim analyses at 1 and 3 years for primary and secondary outcomes. Additionally, substudies will be performed on the completeness of the closure using transesophageal echocardiography/cardiac computed tomography and long-term ECG recording at one year after the operation.

Combined Mitral and Aortic Valve Surgery: 17-year Experience in a Single Center.

BACKGROUND AND OBJECTIVE: It is not uncommon that patients requiring valve surgery have several simultaneous valvular dysfunctions. Combined aortic and mitral valve surgery is the most common form of double-valve surgery. The aim of this study was to analyze and present the outcomes of simultaneous aortic and mitral valve surgery in a single center in a real-life setting. METHODS: The study population consisted of 150 patients operated in the Kuopio University Hospital from 2004 to 2020. All patients undergoing concomitant mitral and aortic valve surgery were included. Four groups were formed based on either the etiology or pathophysiology of the valvular dysfunction. The most common combination was mitral regurgitation with aortic regurgitation (n = 72, 48%), followed by mitral regurgitation with aortic stenosis (n = 37, 25%), endocarditis (n = 29, 19%), and mitral stenosis with aortic regurgitation or stenosis (n = 12, 8%). Concomitant coronary artery revascularization was performed in 37 (25%) patients and tricuspid valve repair in 26 (17%) patients. RESULTS: Operative mortality was 2% and 30-day mortality was 7%. Overall survival was 86%, 78%, and 61% in 3, 5, and 10 years, respectively. Patients with endocarditis were significantly more morbid, and more often than other patients had to undergo an emergency operation. There were no significant differences between the groups in terms of early and late survival. In the overall cohort, the EuroSCORE II value, increased pulmonary artery pressure, decreased glomerular filtration, and length of the operation displayed a negative correlation with survival. CONCLUSIONS: Despite the challenging nature of multivalvular heart disease, surgery is a safe method of treatment with good short- and long-term outcomes.

Thoracoscopic Versus Transaxillary Approach to First Rib Resection in Thoracic Outlet Syndrome.

BACKGROUND: This study assessed the feasibility of fully endoscopic thoracoscopic first rib resection (FRR) in the treatment of neurogenic thoracic outlet syndrome by comparing early outcomes of the thoracoscopic technique against the traditional transaxillary FRR. METHODS: Between 2009 and 2016, 60 consecutive FRRs were performed on 47 patients with neurogenic thoracic outlet syndrome (13 bilateral procedures). The first 30 procedures were performed using the traditional transaxillary technique, and the novel thoracoscopic technique was used in the next 30 operations with the same indications for operative repair. All data were collected retrospectively by independent investigators. The main issues were operation time, learning curve, hospital length of stay, complications, and clinical follow-up status at 3 months. RESULTS: The groups were similar at baseline. The mean operation time was 83 ± 27 minutes in the thoracoscopic group and 48 ± 12 minutes in the transaxillary group (p < 0.001). The first thoracoscopic procedures were 2 hours long, after which, a steady 1-hour procedure time was achieved. Differences regarding the hospital stay or the need for postoperative pain medication were not significant. Two-thirds reported good or excellent recovery at follow-up in both groups. There were no immediate complications. Plexus neuralgia developed in 1 patient 3 weeks after the thoracoscopic operation, and 3 patients were diagnosed with superficial wound infection after the transaxillary procedure. CONCLUSIONS: This study showed that FRR for neurogenic thoracic outlet syndrome can be done safely with a fully endoscopic approach. However, the technique requires experience with thoracoscopic surgery, and there is a learning curve to the procedure.

Thromboembolisms related to post-operative electrical cardioversions for atrial fibrillation in patients with surgical aortic valve replacement.

Aims: Post-operative atrial fibrillation (POAF) is a frequent complication after open-heart surgery, and cardioversions (CV) are commonly performed to restore sinus rhythm. However, little data exists on thrombo-embolic risk related to early post-operative CV and on the recurrence of POAF after CV. CAREAVR study sought to assess the rate of strokes, transient ischaemic attacks (TIA), and mortality shortly after POAF-triggered CV in patients who underwent isolated surgical aortic valve replacement (SAVR) with a bioprosthesis. Methods and results: Altogether 721 patients underwent isolated SAVR with a bioprosthesis at four Finnish university hospitals. During post-operative hospitalization, after patients with prior chronic AF were excluded, 309/634 (48.7%) of patients had at least one episode of POAF [median time (interquartile range) 3 (3) days], and an electrical CV was performed in 113/309 (36.6%) of them. The length of hospital stay was not affected by CV. At 30 days follow-up, the rate of stroke, TIA or mortality was higher in those AF patients who underwent CV vs. those who did not (9.7% vs. 3.6%, P = 0.04, respectively; adjusted hazard ratio 2.63, 95% confidence interval 1.00-6.92, P = 0.05). Similar proportion of patients in both groups were in AF rhythm at discharge (32.7% vs. 35.7%, P = 0.18); and at 3 months (25.0% vs. 23.6%, P = 0.40), respectively. Conclusion: In this real-world population of patients undergoing isolated SAVR, the rate of POAF was nearly 50%. One-third of these patients underwent an electrical CV, and they exhibited over two-fold risk for thromboembolisms and mortality. Cardioversion did not affect the short-term prevalence of AF.

Pharmacomechanical Thrombectomy in Paget-Schroetter Syndrome.

PURPOSE: The purpose of the study was to evaluate feasibility of pharmacomechanical thrombectomy (PMT) in the treatment of Paget-Schroetter syndrome (PSS) followed by thoracoscopic or open surgical decompression of the subclavian vein. METHODS: Twenty-two out of 27 consecutive patients with PSS received PMT using the Trellis-8 peripheral infusion system (Covidien) between 2010 and 2014. Subsequent surgery was performed in 18 of those patients, 9 patients were treated with thoracoscopic, 7 patients with subclavicular, and 2 patients with transaxillary first rib resection, 4 patients were treated with PMT and anticoagulation alone. Technical success, complications, and patency were registered. RESULTS: PMT was successful in 21 (95 %) patients; 1 patient with unsatisfactory lysis received further catheter-directed thrombolysis, which, however, did not improve the result. The mean endovascular procedure time was 105 ± 33 min (range 70-200 min), and the required median amount of thrombolytic agent was 500,000 international unit (IU; range 250,000-1,000,000 IU). Adjunctive balloon venoplasty and aspiration were used in 18 (82 %) and 7 (32 %) cases, respectively. One patient had an intimal tear of the subclavian vein that was discovered and repaired during surgery. There were no other complications related to the endovascular procedure. At follow-up, 18 of 21 patients (86 %) with follow-up imaging available had patent subclavian vein, and all except 1 of the 22 patients were asymptomatic. The mean follow-up time was 25 ± 17 months. CONCLUSIONS: In experienced hands, PMT is effective for early thrombus removal in PSS. Surgical decompression must be considered after PMT.