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Thomas M.,St. Thomas Hospital | Schymik G.,Stadisches Klinikum und Herzklinik | Walther T.,Herzzentrum | Treede H.,University of Hamburg | And 5 more authors.
Circulation | Year: 2010

Background-: 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. Methods and Results-: 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. CONCLUSION-: 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. © 2010 American Heart Association, Inc.

Wendler O.,Surgery Partners | Walther T.,Heart Center Leipzig | Schroefel H.,Klinik fur Herzchirurgie | Lange R.,Deutsches Herzzentrum | And 3 more authors.
European Journal of Cardio-thoracic Surgery | Year: 2013

Objectives: Transapical (TA) aortic valve implantation using the Edwards SAPIEN™ bioprosthesis was commercially introduced in Europe in January 2008. Limited data on the mid-term results are available. Methods: Using data from the SOURCE-Registry (largest consecutive cohort treated using Edwards SAPIEN™ bioprosthesis in Europe), we report on the mid-term results (≥30 days-2 years) of TA patients. Results: Between November 2007 and December 2009, a total of 1387 patients from 38 European centres underwent TA aortic valve implantation. The mean follow-up is 14.9 months, with 1004 patients who completed 1 year and 464 patients who completed the 2-year follow-up. The mean age of patients was 80.6 ± 7.1 years with a logistic-EuroSCORE of 27.6%. The main co-morbidities were coronary artery disease (55.8%), previous bypass grafting (25.5%), porcelain aorta (10.2%), previous stroke (6.5%) and peripheral vascular disease (26.4%). A total of 840 patients (60.6%) received a 26 mm and 535 (38.6%) a 23 mm Edwards SAPIEN™ bioprosthesis. Survivals at 30 days, 1 year and 2 years were 88.7, 73.8 and 65.1%, respectively. Causes of the 276 deaths observed between >30 days and 2-year follow-up were cardiac in 86 patients (31.2%), non-cardiac in 142 (51.4%) and unknown in 48 (17.4%). Cardiac causes of death included heart failure (33.7%), sudden cardiac death (33.7%), myocardial infarct (8.1%), endocarditis (5.8%) and others (18.6%). Non-cardiac deaths were related to pulmonary disease (21.1%), cancer (12.7%), renal failure (11.3%), stroke (10.6%), gastrointestinal disease (7.7%) and others (36.6%). Using univariable and multivariable analyses, logistic EuroSCORE, renal insufficiency and liver diseases were identified as independent predictors of 2-year mortality. Conclusions: These results demonstrate that in elderly patients with severe co-morbidities, TA aortic valve implantation results in excellent mid-term results. Causes of death during the mid-term follow-up are mainly non-cardiac and related to co-morbidities. © The Author 2012. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Kilner P.J.,CMR Unit | Geva T.,Havard Medical School | Kaemmerer H.,Deutsches Herzzentrum | Trindade P.T.,University of Zurich | And 2 more authors.
European Heart Journal | Year: 2010

This paper aims to provide information and explanations regarding the clinically relevant options, strengths, and limitations of cardiovascular magnetic resonance (CMR) in relation to adults with congenital heart disease (CHD). Cardiovascular magnetic resonance can provide assessments of anatomical connections, biventricular function, myocardial viability, measurements of flow, angiography, and more, without ionizing radiation. It should be regarded as a necessary facility in a centre specializing in the care of adults with CHD. Also, those using CMR to investigate acquired heart disease should be able to recognize and evaluate previously unsuspected CHD such as septal defects, anomalously connected pulmonary veins, or double-chambered right ventricle. To realize its full potential and to avoid pitfalls, however, CMR of CHD requires training and experience. Appropriate pathophysiological understanding is needed to evaluate cardiovascular function after surgery for tetralogy of Fallot, transposition of the great arteries, and after Fontan operations. For these and other complex CHD, CMR should be undertaken by specialists committed to long-term collaboration with the clinicians and surgeons managing the patients. We provide a table of CMR acquisition protocols in relation to CHD categories as a guide towards appropriate use of this uniquely versatile imaging modality.

Habedank D.,DRK Kliniken Berlin Kopenick | Meyer F.J.,Munich Municipal Hospital | Hetzer R.,Deutsches Herzzentrum | Anker S.D.,Center for Clinical and Basic Research | And 2 more authors.
Journal of Cachexia, Sarcopenia and Muscle | Year: 2013

Background: Respiratory muscle (RM) function predicts prognosis in non-cachectic patients with chronic heart failure (CHF). We hypothesized that weakness of RM (maximum inspiratory mouth occlusion pressure, Pimax) is a function of body mass index, and that outcome is more a function of BMI than of Pimax or ventilatory drive (P0.1). Subjects and methods: We enrolled 249 CHF patients (11.2 % female, median age 54.2 years) at the German Heart Institute Berlin. Patients were in NYHA classes I/II/III/IV by n = 16/90/108/35. All patients underwent tests of pulmonary function, RM (Pimax, P0.1), cardiopulmonary exercise testing (peakVO2, VE/VCO2-slope), and right heart catheterization. Results: Mean follow-up time was 18 (1-36) months, 47 patients (18.9 %) died or underwent cardiac assist implantation. Pimax correlated weakly with BMI (r = 0.19), peakVO2 (r = 0.15), and FEV1 (r = 0.34, all p < 0.02), and was lower in females compared to males (3.9 ± 1.7 vs. 6.6 ± 2.7 kPa; p < 0.001). P0.1 correlated with pulmonary pressure (rho = 0.2; p < 0.01) and peakVO2 (rho = -0.14; p < 0.02). Neither Pimax [hazard ratio (HR) 0.98; confidence interval (CI) 0.88-1.08] nor P0.1 (HR 0.52; 0.06-4.6) predicted survival. Multivariate regression analysis revealed gender, BMI, and FEV1 as cofactors of Pimax, with only BMI (HR 0.87; CI 0.80-0.95) predicting survival independently. The lowest quintile in BMI had the worst outcome (log-rank χ2 = 13.5, p = 0.009). Summary: In CHF patients including cachexia and NYHA IV, Pimax does not predict survival. Pimax depends on gender, BMI, FEV1, and peakVO2, with only BMI and peakVO2 predicting survival. The impaired Pimax in CHF might be a result of catabolism and weight loss and is not a predictive factor in itself. © 2013 Springer-Verlag Berlin Heidelberg.

Objectives: This study sought to investigate the efficacy, safety, and antiplatelet effect of prasugrel as compared with clopidogrel in patients with high on-treatment platelet reactivity (HTPR) after elective percutaneous coronary intervention (PCI). Background: The extent to which prasugrel can correct HTPR and improve clinical outcomes in patients undergoing elective PCI is unknown. Methods: Stable coronary artery disease (CAD) patients with HTPR (>208 P2Y 12 reaction units [PRU] by the VerifyNow test) after elective PCI with at least 1 drug-eluting stent (DES) were randomly assigned to either prasugrel 10 mg daily or clopidogrel 75 mg daily. Platelet reactivity of the patients on the study drug was reassessed at 3 and 6 months. The study was stopped prematurely for futility because of a lower than expected incidence of the primary endpoint. Results: In 212 patients assigned to prasugrel, PRU decreased from 245 (225 to 273) (median [interquartile range]) at baseline to 80 (42 to 124) at 3 months, whereas in 211 patients assigned to clopidogrel, PRU decreased from 249 (225 to 277) to 241 (194 to 275) (p < 0.001 vs. prasugrel). The primary efficacy endpoint of cardiac death or myocardial infarction at 6 months occurred in no patient on prasugrel versus 1 on clopidogrel. The primary safety endpoint of non-coronary artery bypass graft Thrombolysis In Myocardial Infarction major bleeding at 6 months occurred in 3 patients (1.4%) on prasugrel versus 1 (0.5%) on clopidogrel. Conclusions: Switching from clopidogrel to prasugrel in patients with HTPR afforded effective platelet inhibition. However, given the low rate of adverse ischemic events after PCI with contemporary DES in stable CAD, the clinical utility of this strategy could not be demonstrated. (Testing platelet Reactivity In patients underGoing elective stent placement on clopidogrel to Guide alternative thErapy with pRasugrel [TRIGGER-PCI]; NCT00910299). © 2012 American College of Cardiology Foundation.

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