Percutaneous mitral valve interventions in the real world: Early and 1-year results from the ACCESS-EU, A prospective, multicenter, nonrandomized post-approval study of the Mitraclip therapy in Europe
Maisano F.,San Raffaele Scientific Institute |
Franzen O.,Rigshospitalet |
Baldus S.,University of Hamburg |
Hausleiter J.,Deutsches Herzzentrum Munich |
And 7 more authors.
Journal of the American College of Cardiology | Year: 2013
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. © 2013 by the American College of Cardiology Foundation Published by Elsevier Inc. Source
Walther T.,Kerckhoff Herzzentrum |
Hamm C.W.,Abteilung Radiologie |
Schuler G.,Abteilung Radiologie |
Berkowitsch A.,Abteilung Radiologie |
And 10 more authors.
Journal of the American College of Cardiology | Year: 2015
Background Transcatheter aortic valve replacement (TAVR) has evolved into a routine procedure with good outcomes in high-risk patients. Objectives TAVR complication rates were evaluated based on prospective data from the German Aortic Valve Registry (GARY). Methods From 2011 to 2013, a total of 15,964 TAVR procedures were registered. We evaluated the total cohort for severe vital complications (SVCs), including the following: death on the day of intervention, conversion to sternotomy, low cardiac output that required mechanical support, aortic dissection, and annular rupture; technical complications of the procedures (TCOs), such as repositioning or retrieval of the valve prosthesis and embolization of the prosthesis; and other complications. Results Mean patient age was 81 ± 6 years, 54% of the patients were women, the median logistic Euroscore I was 18.3, the German aortic valve score was 5.6, and the Society of Thoracic Surgeons score was 5.0. Overall in-hospital mortality was 5.2%, whereas SVCs occurred in 5.0% of the population. Independent predictors for SVCs were female sex, pre-operative New York Heart Association functional class IV, ejection fraction <30%, pre-operative intravenous inotropes, arterial vascular disease, and higher degree of calcifications. TCOs occurred in 4.7% of patients and decreased significantly from 2011 to 2013. An emergency sternotomy was performed in 1.3% of the patients; however, multivariate analysis did not identify any predictors for conversion to sternotomy. Conclusions The all-comers GARY registry revealed good outcomes after TAVR and a regression in complications. Survival of approximately 60% of patients who experienced SVCs or who required sternotomy underlines the need for heart team-led indication, intervention, and follow-up care of TAVR patients. © 2015 American College of Cardiology Foundation. Source
Meredith Am I.T.,Monash University |
Walters D.L.,University of Queensland |
Dumonteil N.,Toulouse University Hospital Center |
Worthley S.G.,Royal Adelaide Hospital |
And 12 more authors.
Journal of the American College of Cardiology | Year: 2014
Results Mean age was 84.4 years, 57% of the patients were female, and 76% were New York Heart Association functional class III/IV. Mean aortic valve area was 0.7 ± 0.2 cm2. The valve was successfully implanted in all patients, with no cases of valve embolization, ectopic valve deployment, or additional valve implantation. All repositioning (n = 26) and retrieval (n = 6) attempts were successful; 34 patients (28.6%) received a permanent pacemaker. The primary device performance endpoint was met, because the mean gradient improved from 46.4 ± 15.0 mm Hg to 11.5 ± 5.2 mm Hg. At 30 days, the mortality rate was 4.2%, and the rate of disabling stroke was 1.7%; 1 (1.0%) patient had moderate PVR, whereas none had severe PVR.Conclusions REPRISE II demonstrates the safety and effectiveness of the Lotus valve in patients with severe aortic stenosis who are at high surgical risk. The valve could be positioned successfully with minimal PVR. (REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance; NCT01627691).Background Transcatheter aortic valve replacement provides results comparable to those of surgery in patients at high surgical risk, but complications can impact long-term outcomes. The Lotus valve, designed to improve upon earlier devices, is fully repositionable and retrievable, with a unique seal to minimize paravalvular regurgitation (PVR).Objectives The prospective, single-arm, multicenter REPRISE II study (REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System: Evaluation of Safety and Performance) evaluated the transcatheter valve system for treatment of severe symptomatic calcific aortic valve stenosis.Methods Patients (n = 120; aortic annulus 19 to 27 mm) considered by a multidisciplinary heart team to be at high surgical risk received the valve transfemorally. The primary device performance endpoint, 30-day mean pressure gradient, was assessed by an independent echocardiographic core laboratory and compared with a pre-specified performance goal. The primary safety endpoint was 30-day mortality. Secondary endpoints included safety/effectiveness metrics per Valve Academic Research Consortium criteria. © 2014 American College of Cardiology Foundation. Source
Sonne C.,Deutsches Herzzentrum Munich
GMS Zeitschrift für medizinische Ausbildung | Year: 2013
Regular student evaluations at the Technical University Munich indicate the necessity for improvement of the clinical examination course. The aim of this study was to examine if targeted measures to restructure and improve a clinical examination course session lead to a higher level of student satisfaction as well as better self-assessment of the acquired techniques of clinical examination. At three medical departments of the Technical University Munich during the 2010 summer semester, the quantitative results of 49 student evaluations (ratings 1-6, German scholastic grading system) of the clinical examination course were compared for a course before and a course after structured measures for improvement. These measures included structured teaching instructions, handouts and additional material from the Internet. 47 evaluations were completed before and 34 evaluations after the measures for improvement. The measures named above led to a significant improvement of the evaluative ratings in the following areas: short introduction to the topic of each clinical examination course (from 2.4±1.2 to1.7±1.0; p=0.0020) and to basic measures of hygiene (from 3.8±1.9 to 2.5±1.8; p=0.004), structured demonstration of each clinical examination step (from 2.9±1.5 to 1.8±1.0; p=0.001), sufficient practice of each clinical examination step (from 3.1±1.8 to 2.2±1.4; p=0.030) structured feedback on each clinical examination step (from 3.0±1.4 to 2.3±1.0; p=0.0070), use of handouts (from 5.2±1.4 to 1.8±1.4; p<0.001), advice on additional learning material (from 5.0±1.4 to 3.4±2.0; p<0.001), general learning experience (from 2.4±0.9 to 1.9±0.8; p=0.017), and self-assessment of the acquired techniques of clinical examination (from 3.5±1.3 to 2.5±1.1; p<0.01). Structured changes led to significant improvement in the evaluative ratings of a clinical examination course session concerning preparation of the tutors, structure of the course, and confidence in performing physical examinations. Source
Agency: Cordis | Branch: FP7 | Program: CP-IP | Phase: HEALTH-2007-2.4.1-12 | Award Amount: 16.04M | Year: 2009
Recent research suggests that the hypoxic micro-environment of tumours is one of the major drivers of metastatic spread of cancer. Furthermore, hypoxic tumour micro-environments may result in treatment resistance of cancer cells, therefore causing a double effect of reducing the potential of a successful treatment of the cancer patient. This project seeks to clarify the roles and functions of the hypoxic tumour micro-environment in relation to the survival of solid tumours likely to metastasise. We will gain new knowledge about molecular mechanisms behind hypoxia-driven metastasis, like the epithelial-mesenchymal transition (EMT) by several routes: (a): mechanisms related to cell growth- and cell proliferation (UPR, mTOR, CA9, HIF, Notch, and VHL), (b): angiogenesis and lymphangiogenesis, (c): metabolism and pH-regulation (d): the handling of reactive oxygen species (ROS). We will generate animal models for the study of the role of hypoxia in metastases and develop a bio-bank of tumour and blood samples for molecular diagnostic studies. We will identify and develop advanced imaging techniques and biomarkers and identify micro-metastases in bone marrow of patients to assist in the selection of appropriate stratification of the actual primary tumours and metastases micro-environmental conditions. We will also create a machine-learning based classifier of tumour hypoxia. The consortium has the necessary expertise to perform proof-of-principle clinical testing of new treatment strategies. We will thus perform clinical tests of new drugs developed to attack the regulatory mechanisms selected from the pre-clinical work and possible synergisms of combined treatments. We will also test new radiotherapy strategies for treatment of primary as well as metastatic tumours. Cancer types chosen for clinical studies are non-small-cell lung carcinoma, squamous cell carcinoma of the larynx, prostate cancer, primary breast cancer and rectal cancer.