22 research outputs found

    Surveillance for Infrainguinal Vein Graft Stenosis

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    Outcome of valve sparing root replacement for diverse indications

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    Objectives We report the mid-term outcomes of valve-sparing aortic root replacement (VSRR) in a cohort including patients with bicuspid aortic valve (BAV), connective tissue disorder (CTD), aortic dissection (AD), and congenital heart disease (CHD). Design. From 2005 to 2017, 174 patients underwent VSRR with the reimplantation technique. The mean age was 46 +/- 14 years. The mean follow-up time was 4.8 +/- 2.8 years. The indication for operation was aortic aneurysm for 127 (73%), aortic insufficiency (AI) for 38 (22%), and AD for 9 patients (5%). Preoperatively, 53 patients (31%) had >= moderate AI. BAV, CTD (Marfan or Loyes-Dietz), previous Ross procedure, or CHD was present in 57 (33%), 28 (16%), 7 (4%) and 12 patients (7%), respectively. Concomitant aortic valve repair was performed for 103 patients (59%). Results. Thirty-day mortality was zero. Four patients underwent aortic valve replacement (AVR) during follow-up. Kaplan-Meier estimates for survival, freedom from AVR, and freedom from >= moderate AI or reoperation were 96, 98, and 97% at 5 years. There was no difference in survival, freedom from AVR, or freedom from >= moderate AI or reoperation in patients with and without BAV, CTD, leaflet repair, or preoperative >= moderate AI. In Cox regression analysis, BAV, CTD, aortic valve repair, preoperative >= moderate AI, or aortic dimension were not risk factors for reoperation or valve dysfunction. Conclusions. Mid-term outcomes of VSRR for patients with diverse indications in terms of survival, reoperation rate, and valve dysfunction rate were excellent in a center with a limited annual volume of VSSR.Peer reviewe

    SOURCE 3 Registry Design and 30-Day Results of the European Postapproval Registry of the Latest Generation of the SAPIEN 3 Transcatheter Heart Valve

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    BACKGROUND: The SOURCE 3 Registry (SAPIEN Aortic Bioprosthesis European Outcome) is a European multicenter, observational registry of the latest generation of transcatheter heart valve, the SAPIEN 3 (Edwards Lifesciences, Irvine, CA). Its purpose is to document outcomes of clinical safety and performance after European approval was given. METHODS: Here, we present the 30-day outcome of the SOURCE 3 Registry. All data are self-reported, and all participating centers have committed to support their consecutive experience with the SAPIEN 3 transcatheter heart valve, dependent on patient consent, before the start of the study. Adverse events are defined with Valve Academic Research Consortium 2 criteria and adjudicated by an independent clinical events committee. RESULTS: A total of 1950 patients from 80 centers in 10 countries were enrolled between July 2014 and October 2015. Of those, 1947 patients underwent transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 (mean age, 81.6 +/- 6.6 years; 48.1% female). Main comorbidities included coronary artery disease (51.5%), renal insufficiency (27.4%), diabetes mellitus (29.5%), chronic obstructive pulmonary disease (16.0%), and a mean logistic EuroSCORE of 18.3 +/- 13.2. Transfemoral access was used in 87.1% (n=1695); nontransfemoral, in 252 patients. Conscious sedation was used in 59.9% of transfemoral procedures, and in 50% of patients, TAVI was performed without aortic balloon valvuloplasty. Implantation success (1 valve in the intended location) was 98.3%. Conversion to conventional surgery (0.6%) and use of cardiopulmonary bypass (0.7%) were rare. Adverse events were low, with site-reported 30-day all-cause mortality of 2.2%, cardiovascular mortality of 1.1%, stroke of 1.4%, major vascular complications of 4.1%, life-threatening bleeding of 5%, and post-TAVI pacemaker implantation of 12%. Moderate or greater paravalvular regurgitation was observed in 3.1% of reporting patients. CONCLUSIONS: Results from the SOURCE 3 Registry demonstrate contemporary European trends and good outcomes of TAVI in daily practice when this third-generation TAVI device is used.Peer reviewe

    Occurrence and Classification of Cerebrovascular Events after Isolated Bioprosthetic Surgical Aortic Valve Replacement: A Competing Risk Analysis of the CAREAVR Study

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    Background: The long-term incidence of stroke and the proportion of cardioembolic events after bioprosthetic surgical aortic valve replacement (SAVR) remain largely unknown.Methods: The CAREAVR study sought to assess the rate of stroke and transient ischemic attack (TIA) in patients who underwent isolated surgical aortic valve replacement with a bioprosthesis at four Finnish university hospitals between 2002 and 2014. Data was collected retrospectively and included 721 patients. Median follow-up time was 4.8 [3.0–7.0] years.Results: At 5 years, freedom from stroke was 89.0%, from TIA 94.1%, and from stroke and TIA 83.7%. The median time between index procedure and stroke or TIA was 1.7 years [29 days–3.9 years]. Stroke was of cardioembolic origin in 44.4% of patients. In multivariable competing risk analysis, increased age (HR 1.03, 95%CI 1.00–1.06, p = 0.022), previous stroke or TIA (HR 1.75, 95%CI 1.14–2.70, p = 0.010), New York Heart Association (NYHA) class III or more (HR 1.51, 95%CI 1.01–2.24, p = 0.044) and insulin treatment at discharge (HR 1.20, 95%CI 1.09–3.64, p = 0.024) were independent predictors of stroke or TIA. Cerebrovascular events occurred in 47.2% of patients with ongoing anticoagulation therapy.Conclusion: In this study, the incidence of stroke in the early postoperative period after bioprosthetic SAVR was higher than previously documented. Almost half of strokes were of cardioembolic etiology. These findings highlight the need for the better prevention strategies for cardioembolic events after bioprosthetic SAVR.</p

    Clinical outcomes of combined aortic root replacement with mitral valve surgery

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    ObjectiveThis study was undertaken to examine the operative mortality and morbidity and late outcomes in patients who required combined aortic root replacement with mitral valve surgery.MethodsThese combined procedures were performed in 123 patients with a mean age of 51 ± 16 years; 67% were men. The aortic root pathology was an aneurysm in 76 patients and other disorders in 47 patients. The mitral valve pathology was degenerative disease in 62 patients and other diseases in 61 patients. Sixty-four patients (52%) underwent previous cardiac surgery. The aortic valve was preserved in 21 patients, and the mitral valve was preserved in 67 patients; the remaining patients underwent valve replacement. In addition, 57 patients underwent other procedures. The mean follow-up was 4.9 ± 4.3 years and complete.ResultsThe operative mortality rate was 6.5% (8 patients), and late mortality was 9.7% (12 patients). Reexploration of the mediastinum for bleeding (15%) and implantation of permanent pacemaker (18%) were the most common postoperative complications. Urgent surgery and functional class IV were predictors of operative mortality by univariate analysis. Survival at 1, 5, and 10 years was 90.9% ± 2.6%, 86.1% ± 3.3%, and 79.3 ± 4.9%, respectively. Six patients required reoperation. Freedom from reoperation at 1, 5, and 10 years was 100%, 96.4% ± 2.5%, and 85.7% ± 6.4%, respectively. At the latest follow-up, 98 patients were alive and free from reoperation; 92 patients were in functional classes 1 and 2, and 88 patients were free from any cardiac or valve-related complication.ConclusionAortic root replacement combined with mitral valve surgery is a complex operation associated with high morbidity, but the operative mortality is reasonably low and the long-term outcomes are gratifying

    Intraoperative flow predicts the development of stenosis in infrainguinal vein grafts

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    AbstractObjective: There are data to suggest that the development of myointimal hyperplasia is affected by long-term alterations in blood flow. However, the clinical relevance of these findings has not been demonstrated. Methods: In this retrospective clinical study, intraoperative volume flow measurement with transit time flowmeter was performed in 257 infrainguinal vein grafts carried out in 241 patients. The patients were enrolled in an intensive duplex scanning–based surveillance program. The relationship between the intraoperative graft flow and subsequent occlusion or development of stenosis was evaluated and controlled for other pertinent risk factors. Results: The median follow-up time was 13.6 months. A graft stenosis was found in 58 grafts. The mean graft flow for event-free grafts was 98 mL/min, which was significantly higher compared with 78 mL/min for stenosed or 69 mL/min for occluded grafts. The patients were divided into four groups according to quartiles of the sample distribution of graft flow measurements. The respective 2-year primary and assisted primary patency rates in the lowest to the highest graft flow groups were 39%, 49%, 47%, and 72% (P =.003) and 55%, 67%, 71%, and 84% (P =.01). Analogous significant differences were observed for maximal flow capacity measurements. Female sex (P =.009) and low graft flow in maximal flow capacity measurements (P =.003) were independent predictors of stenosis development in the multiple regression model. Conclusion: Intraoperative graft volume flow is a predictor of bypass occlusion after infrainguinal bypass. In addition, this study verifies an association between the development of clinically evident graft stenoses and low graft flow. (J Vasc Surg 2001;34:269-76.
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