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      Transapical aortic valve implantation using a Symetis Acurate self-expandable bioprosthesis: initial outcomes of 10 patients

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          Abstract

          Introduction

          Transapical aortic valve implantation (TA-AVI) has been widely introduced for treatment of patients with severe aortic stenosis in the last decade. Here we report our first clinical experience with 10 patients using the second-generation transapical Symetis Acurate TA aortic valve designed for transapical implantation.

          Aim

          To evaluate the results of transapical access in transcatheter aortic valve implantation (TAVI) among patients with unsuitable vascular access.

          Material and methods

          All patients had been assessed by a local heart team and were disqualified from surgical aortic valve replacement (AVR) and the transfemoral TAVI approach. Mean age was 75.4 ±3.9 years (range: 68–80), with 20% being female. Logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) and STS (Society of Thoracic Surgeons) were 15.4 ±8.9% and 20.5 ±4.5%, respectively.

          Results

          All implantations were performed successfully in the intra-annular and subcoronary position. There were no conversions to surgical AVR. All patients survived 30-day follow-up. No strokes or transient ischemic attacks were reported. There was no need for pacemaker implantation and none of the patients demonstrated moderate or significant paravalvular leakage. The mean aortic gradients improved significantly from a baseline of 57.0 ±19.2 mm Hg to a 30-day value of 14.2 ±4.1 mm Hg.

          Conclusions

          Our initial clinical results indicate satisfactory functionality in patients after trans-apical implantation of the Symetis Acurate aortic valve. The procedure of implantation seems to be straightforward and may be considered in patients in whom a transfemoral approach is not a good option.

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          Most cited references17

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          Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.

          Transcatheter aortic valve implantation was developed to mitigate the mortality and morbidity associated with high-risk traditional aortic valve replacement. The Edwards SAPIEN valve was approved for transcatheter aortic valve implantation transfemoral delivery in the European Union in November 2007 and for transapical delivery in January 2008. The SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess the initial clinical results of the Edwards SAPIEN valve in consecutive patients in Europe after commercialization. Cohort 1 consists of 1038 patients enrolled at 32 centers. Patients who were treated with the transapical approach (n=575) suffered more comorbidities than the transfemoral patients (n=463), resulting in a significantly higher logistic EuroSCORE (29.1% versus 25.7%; P<0.001). Therefore, these groups are considered different, and outcomes cannot be compared. Overall short-term procedural success was observed in 93.8%. The incidence of valve embolization was 0.3% (n=3), and coronary obstruction was reported for 0.6% (n=6 cases). Incidence of stroke was 2.5% and similar for both procedural approaches. Thirty-day mortality was 6.3% in transfemoral patients and 10.3% in transapical patients. The occurrence of vascular complications was not a predictor of <30-day mortality in the transfemoral population. Technical proficiency can be learned and adapted readily as demonstrated by the short-term procedural success rate and low 30-day mortality rates reported in the SOURCE Registry. Specific complication management and refinement of patient selection are needed to further improve outcomes.
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            Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome.

            We sought to determine both the procedural performance and safety of percutaneous implantation of the second (21-French [F])- and third (18-F)-generation CoreValve aortic valve prosthesis (CoreValve Inc., Irvine, California). Percutaneous aortic valve replacement represents an emerging alternative therapy for high-risk and inoperable patients with severe symptomatic aortic valve stenosis. Patients with: 1) symptomatic, severe aortic valve stenosis (area or =80 years with a logistic EuroSCORE > or =20% (21-F group) or age > or =75 years with a logistic EuroSCORE > or =15% (18-F group); or 3) age > or =65 years plus additional prespecified risk factors were included. Introduction of the 18-F device enabled the transition from a multidisciplinary approach involving general anesthesia, surgical cut-down, and cardiopulmonary bypass to a truly percutaneous approach under local anesthesia without hemodynamic support. A total of 86 patients (21-F, n = 50; 18-F, n = 36) with a mean valve area of 0.66 +/- 0.19 cm2 (21-F) and 0.54 +/- 0.15 cm2 (18-F), a mean age of 81.3 +/- 5.2 years (21-F) and 83.4 +/- 6.7 years (18-F), and a mean logistic EuroSCORE of 23.4 +/- 13.5% (21-F) and 19.1 +/- 11.1% (18-F) were recruited. Acute device success was 88%. Successful device implantation resulted in a marked reduction of aortic transvalvular gradients (mean pre 43.7 mm Hg vs. post 9.0 mm Hg, p < 0.001) with aortic regurgitation grade remaining unchanged. Acute procedural success rate was 74% (21-F: 78%; 18-F: 69%). Procedural mortality was 6%. Overall 30-day mortality rate was 12%; the combined rate of death, stroke, and myocardial infarction was 22%. Treatment of severe aortic valve stenosis in high-risk patients with percutaneous implantation of the CoreValve prosthesis is feasible and associated with a lower mortality rate than predicted by risk algorithms.
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              Aortic regurgitation after transcatheter aortic valve implantation: incidence and early outcome. Results from the German transcatheter aortic valve interventions registry.

              Significant aortic regurgitation (AR) is rare following surgical aortic valve replacement and has been associated with worse outcome. Following transcatheter aortic valve implantation (TAVI), AR is common, but little is known about its determinants and its effect on clinical outcome. To evaluate early outcome and risk factors possibly associated with AR after TAVI. Data were analysed from 690 patients with severe aortic stenosis treated with TAVI enrolled in the prospective multicentre German transcatheter aortic valve interventions registry. The occurrence of AR was evaluated angiographically after device deployment and removal of the catheter and guidewire. Significant AR was defined as AR≥2/4. The study population's mean age was 81.4±6.3 years and men represented 44%. The mean logistic Euroscore was 20.4±13.1%. Overall, 84% of patients received the Medtronic CoreValve system and 16% received the Edwards Sapien valve. Significant AR occurred in 119 patients (17.2%). Factors independently associated with significant AR were aortic valve area (adjusted OR=0.10), annulus measurement by transoesophageal echocardiography (adjusted OR=1.94), male gender (adjusted OR=1.80), cardiogenic shock (adjusted OR=1.94) and renal failure (adjusted OR=0.53). In-hospital death rates were significantly higher in patients with significant AR than in those with no/mild AR (15.1% vs 6.7%, OR=2.50, 95% CI 1.37 to 4.55), as were rates of low cardiac output (20% vs 4.4%) and respiratory failure (16.5% vs 7.1%). Using multivariate analysis, the presence of post-procedural AR≥2/4 remained a strong independent predictor of in-hospital death (adjusted OR=2.43, 95% CI 1.22 to 4.85). Significant AR after TAVI is common and is associated with increased in-hospital mortality. Long-term follow-up is critical to further define the impact of residual AR on clinical outcome. Until these data become available, every effort should be made to prevent and treat this complication.
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                Author and article information

                Journal
                Wideochir Inne Tech Maloinwazyjne
                Wideochir Inne Tech Maloinwazyjne
                WIITM
                Videosurgery and other Miniinvasive Techniques
                Termedia Publishing House
                1895-4588
                2299-0054
                27 April 2017
                June 2017
                : 12
                : 2
                : 172-177
                Affiliations
                [1 ]Department of Cardiosurgery and Transplantology, Poznan University of Medical Sciences, Poznan, Poland
                [2 ]Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland
                Author notes
                Address for correspondence Marcin Misterski MD, PhD, Department of Cardiosurgery and Transplantology, Poznan University of Medical Sciences, 1/2 Długa St, 61-841 Poznan, Poland. phone: +48 606 955 354. e-mail: mister@ 123456poczta.onet.pl
                Article
                29873
                10.5114/wiitm.2017.67481
                5502338
                9b90ecc6-c0b0-47a8-86bf-179244060176
                Copyright: © 2017 Fundacja Videochirurgii

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) License, allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.

                History
                : 20 February 2017
                : 05 April 2017
                Categories
                Original Paper

                aortic stenosis,transcatheter aortic valve implantation,transapical valve implantation,symetis acurate valve

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