Objectives The purpose of this article is to report early and mid-term outcomes of the ACCESS-EU study (ACCESS-Europe A Two-Phase Observational Study of the MitraClip System in Europe), a European ...prospective, multicenter, nonrandomized post-approval study of MitraClip therapy (Abbott Vascular, Inc., Santa Clara, California). Background MitraClip has been increasingly performed in Europe after approval; the ACCESS-EU registry provides a snapshot of the real-world clinical demographic data and outcomes. Methods A total of 567 patients with significant mitral valve regurgitation (MR) underwent MitraClip therapy at 14 European sites. Mean logistic European System for Cardiac Operative Risk Evaluation at baseline was 23.0 ± 18.3; 84.9% patients were in New York Heart Association functional class III or IV, and 52.7% of patients had an ejection fraction ≤40%. Results The MitraClip implant rate was 99.6%. A total of 19 patients (3.4%) died within 30 days after the MitraClip procedure. The Kaplan-Meier survival at 1 year was 81.8%. Intensive care unit and hospital length of stay was 2.5 ± 6.5 days and 7.7 ± 8.2 days, respectively. Single leaflet device attachment was reported in 27 patients (4.8%). There were no MitraClip device embolizations. Thirty-six subjects (6.3%) required mitral valve surgery within 12 months after the MitraClip implant procedure. There was improvement in the severity of MR at 12 months, compared with baseline (p < 0.0001), with 78.9% of patients free from MR, severity of >2+ at 12 months. At 12 months, 71.4% of patients had New York Heart Association functional class II or class I. Six-min-walk-test improved 59.5 ± 112.4 m, and Minnesota-living-with-heart-failure score improved 13.5 ± 20.5 points. Conclusions In the real-world, post-approval experience in Europe, patients undergoing the MitraClip therapy are high-risk, elderly patients, mainly affected by functional MR. In this patient population, the MitraClip procedure is effective with low rates of hospital mortality and adverse events.
Patients who had undergone successful TAVR were randomly assigned to receive either a rivaroxaban-based antithrombotic regimen or an antiplatelet-based antithrombotic regimen. At 17 months, the ...primary outcome of death or thromboembolic complications occurred more frequently with rivaroxaban.
Abstract Objectives This analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of ...pure aortic regurgitation. Background Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus. Methods Transapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE European System for Cardiac Operative Risk Evaluation 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed. Results Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI. Conclusions Aortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection.
Valve-in-Valve Transcatheter Aortic Valve Implantation for Degenerated Bioprosthetic Heart Valves Holger Eggebrecht, Ulrich Schäfer, Hendrik Treede, Peter Boekstegers, Jörg Babin-Ebell, Markus ...Ferrari, Helge Möllmann, Helmut Baumgartner, Thierry Carrel, Philipp Kahlert, Philipp Lange, Thomas Walther, Raimund Erbel, Rajendra H. Mehta, Matthias Thielmann Multicenter data from 47 patients aged 64 to 97 years undergoing transfemoral (n = 25) or transapical (n = 22) valve-in-valve (viv) transcatheter aortic valve implantation (TAVI) for degenerated surgically implanted bioprosthetic heart valves were analyzed. Procedural success was obtained in all patients. Vascular access complications occurred in 6 (13%). Five (11%) patients required new pacemaker implantation. Valvular function was excellent with respect to valve competence, but increased transvalvular gradients ≥20 mm Hg were noted in 44%. Mortality at 30 days was 17% (1 procedural and 7 post-procedural deaths). Valve-in-valve TAVI can be performed with high technical success rates, acceptable post-procedural valvular function, and excellent functional improvement.
This report describes the 12-month outcomes of the a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe (ACCESS-EU postapproval study of MitraClip therapy) ...with respect to preprocedural left ventricular ejection fraction (LVEF). Transcatheter deployment of the MitraClip device may be considered for patients who are not suitable for conventional surgery. A total of 567 patients with significant mitral regurgitation (MR) underwent MitraClip therapy. Of those, 393 had functional MR (FMR) and were subdivided by preprocedural LVEF (A: 10% to 20%, B: >20% to 30%, C: >30% to 40%, D: >40%). Procedural safety and efficacy and treatment outcomes including MR grade, New York Heart Association (NYHA) functional class, 6-minute walk test, and the Minnesota Living with Heart Failure Questionnaire were analyzed at baseline, 30 days, and 12 months. Baseline mean logistic EuroSCORE was 25 ± 19; 87% of patients were in NYHA classes III or IV (A: 96%, B: 83%, C: 90%, D: 86%). There was no incidence of death or stroke intraprocedurally. Eleven patients died within 30 days with no differences among subgroups. Kaplan–Meier survival at 12 months was 81.8% (A: 71%, B: 79%, C: 87%, D: 86%). There was a significant improvement in MR severity at 30 days and 12 months (p <0.0001). At 12 months, all subgroups experienced similar improvements in NYHA class, 6-minute walk test, and Minnesota Living with Heart Failure Questionnaire. This real-world registry reports promising results of MitraClip therapy in patients with FMR. In conclusion, the low rates of hospital mortality and adverse events in patients with FMR—even in patients with severely reduced LVEF—provide additional evidence of substantial benefits after MitraClip implantation.
Abstract Objectives This study sought to investigate the prevalence of abnormal von Willebrand multimers (AbM) in patients undergoing transcatheter aortic valve replacement (TAVR) and the impact of ...TAVR on the underlying factor variances. Background An association between the acquired von Willebrand syndrome (aVWS) and valvular aortic stenosis (AS) has been established in the past and surgical aortic valve replacement (SAVR) shown to lead to factor recovery. Prevalence and course of AbM in patients treated with TAVR though has not yet been described comprehensively. Methods Ninety-five consecutive patients underwent TAVR at our institution. Hemostaseologic testing was performed before and up to 1 week after TAVR. Transvalvular and right heart hemodynamics as well as bleeding episodes were recorded and analyzed with descriptive statistics. Results Baseline prevalence of AbM was 42% with an average high-molecular-weight multimer (HMWM) count of 16.2 ± 3.3%. Pressure gradients correlated significantly with the extent of HMWM deficiency (r = –0.63 p < 0.0001). Following valve implantation, HMWM increased proportional to the drop in mean pressure gradient and normalized in most of the patients. However, residual aortic regurgitation/leakage led to inferior HMWM recovery but prosthesis-patient mismatch (PPM) was rare and left HMWM uninfluenced. We saw no association of transfusion with AbM and 1-year mortality was unaffected by AbM. Conclusions AbM in patients with AS undergoing TAVR is frequent. However, TAVR is capable of correcting AbM and therefore possibly aVWS in patients with AS. As opposed to SAVR, bleeding and transfusion requirement in TAVR patients was not associated with severe HMWM deficiency; PPM was rare and HMWM were uninfluenced by the procedure. Aortic regurgitation after TAVR adversely influenced HMWM recovery.
The content of 5 macro elements (Na, K, Ca, Mg, and P), 6 trace elements (Fe, Mn, Zn, Cu, Se, and I), and 4 ultra-trace elements (As, Pb, Cd, and Hg) in 34 edible dried seaweed products of brown ...algae (Laminaria sp., Undaria pinnatifida, and Hizikia fusiforme) and red algae (Porphyra sp.) originated from China, Japan, and Korea and bought by retail in Germany was determined. The content of these elements was analyzed by spectrometric methods (ICP–AES, ICP–MS, HGAAS, and CVAAS). Assuming a daily intake with 5 g FM of algae, the contribution of the essential elements to the diet is low, with the exception of I. Brown algae contained as much as 1316 ± 1669 mg of I/kg FM. More than 4000 mg of I/kg FM were found in several Laminaria sp. Moreover, some brown algae, such as Hizikia fusiforme, had high contents of total As (87.7 ± 8.2 mg/kg FM).
We sought to assess the impact of tricuspid regurgitation (TR) severity on patient outcome in a collective with relevant mitral regurgitation undergoing MitraClip implantation..
From August 2010 to ...July 2013, 766 patients (age 75.3±8.5 years, 61% male, median EuroSCORE 24.3%±18.4) were prospectively enrolled in the TRAMI registry and stratified by echocardiography into no/mild, moderate and severe TR. Overall, the mean number of implanted MitraClips was higher in patients with severe TR but increasing TR severity was not associated with procedural success. In-hospital and one-year mortality as well as MACE and MACCE (death, myocardial infarction±stroke) rates were higher with increasing TR severity. Kaplan-Meier curves indicated a significant difference for mortality (p<0.0001), but not for rehospitalisation for heart failure. After multivariate Cox regression, severe TR proved to be a predictor for one-year mortality (HR 2.01, 95% CI: 1.25-3.26, p=0.004). Higher rates of severe bleeding were more frequent with increasing TR grades.
In patients with MitraClip implantation, increasing TR severity is associated with adverse outcome, higher bleeding rates and decreased survival rates.
IMPORTANCE Transcatheter aortic valve replacement (TAVR) is an effective treatment option for high-risk patients with severe aortic stenosis. Different from surgery, transcatheter deployment of ...valves requires either a balloon-expandable or self-expandable system. A randomized comparison of these 2 systems has not been performed. OBJECTIVE To determine whether the balloon-expandable device is associated with a better success rate than the self-expandable device. DESIGN, SETTING, AND PATIENTS The CHOICE study was an investigator-initiated trial in high-risk patients with severe aortic stenosis and an anatomy suitable for the transfemoral TAVR procedure. One hundred twenty-one patients were randomly assigned to receive a balloon-expandable valve (Edwards Sapien XT) and 120 were assigned to receive a self-expandable valve (Medtronic CoreValve). Patients were enrolled between March 2012 and December 2013 at 5 centers in Germany. INTERVENTIONS Transfemoral TAVR with a balloon-expandable or self-expandable device. MAIN OUTCOMES AND MEASURES The primary end point was device success, which is a composite end point including successful vascular access and deployment of the device and retrieval of the delivery system, correct position of the device, intended performance of the heart valve without moderate or severe regurgitation, and only 1 valve implanted in the proper anatomical location. Secondary end points included cardiovascular mortality, bleeding and vascular complications, postprocedural pacemaker placement, and a combined safety end point at 30 days, including all-cause mortality, major stroke, and other serious complications. RESULTS Device success occurred in 116 of 121 patients (95.9%) in the balloon-expandable valve group and 93 of 120 patients (77.5%) in the self-expandable valve group (relative risk RR, 1.24, 95% CI, 1.12-1.37, P < .001). This was attributed to a significantly lower frequency of residual more-than-mild aortic regurgitation (4.1% vs 18.3%; RR, 0.23; 95% CI, 0.09-0.58; P < .001) and the less frequent need for implanting more than 1 valve (0.8% vs 5.8%, P = .03) in the balloon-expandable valve group. Cardiovascular mortality at 30 days was 4.1% in the balloon-expandable valve group and 4.3% in the self-expandable valve group (RR, 0.97; 95% CI, 0.29-3.25; P = .99). Bleeding and vascular complications were not significantly different, and the combined safety end point occurred in 18.2% of those in the balloon-expandable valve group and 23.1% of the self-expandable valve group (RR, 0.79; 95% CI, 0.48-1.30; P = .42). Placement of a new permanent pacemaker was less frequent in the balloon-expandable valve group (17.3% vs 37.6%, P = .001). CONCLUSIONS AND RELEVANCE Among patients with high-risk aortic stenosis undergoing TAVR, the use of a balloon-expandable valve resulted in a greater rate of device success than use of a self-expandable valve. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01645202
The VIVA (Valve in Valve) trial was designed to systematically and prospectively collect data regarding the use of transcatheter aortic valve replacement in patients with failing surgical aortic ...bioprostheses at high-risk for reoperation.
Surgical aortic valve replacement has been the standard of care in symptomatic patients with aortic valve disease. However, bioprosthetic valves degenerate over time, requiring redo surgery.
VIVA is an international, observational, single-arm, postmarket study conducted at 23 sites that enrolled 202 patients with symptomatic degeneration of an aortic bioprosthesis eligible for elective treatment with a CoreValve or Evolut R self-expanding transcatheter aortic valve.
Patients were elderly (mean age 79.9 years), 47.5% were men, and they had a mean Society of Thoracic Surgeons score of 6.6%. Although 41.8% of patients had surgical bioprostheses with labeled size ≤21 mm, valve hemodynamic parameters were markedly improved from baseline (mean aortic valve gradient 35.0 ± 16.3 mm Hg) to discharge (17.5 ± 8.6 mm Hg) and were sustained at 1 year (15.5 ± 7.5 mm Hg). At 1 year, total aortic regurgitation greater than mild was measured in 1.1% of patients. Clinical outcomes at 30 days demonstrated low mortality (2.5%), no disabling strokes, a 0.5% rate of acute kidney injury, and an 8.0% rate of new pacemaker implantation. At 1 year, the mortality rate remained low (8.8%), with 1 disabling stroke (0.6%). Five patients (2.5%) experienced coronary artery obstructions, 3 during and 1 immediately after the procedure and 1 several months later.
Degenerated surgical bioprostheses can be safely treated with the CoreValve or Evolut R platform using the catheter-based valve-in-valve procedure. Excellent 1-year clinical and hemodynamic outcomes were achieved in this real-world patient population. (CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis; NCT02209298)
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