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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.


Thomas M.,St Thomas Hospital | Schymik G.,Stadisches Klinikum und Herzklinik | Walther T.,Herzzentrum | Himbert D.,Hopital Bichat | And 7 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.


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.


Thomas M.,Kings Health Partners | Schymik G.,Stadtisches Klinikum und Herzklinik | Walther T.,Herzzentrum | Himbert D.,Hopital Bichat | And 7 more authors.
Circulation | Year: 2011

Bacground-: Transcatheter aortic valve implantation was developed to provide a therapeutic option for patients considered to be ineligible for, and to mitigate mortality and morbidity associated with, high-risk surgical aortic valve replacement. Methods and Results-: The Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess initial post commercial clinical transcatheter aortic valve implantation results of the Edwards SAPIEN valve in consecutive patients in Europe. Cohort 1 consists of 1038 patients enrolled at 32 centers. One-year outcomes are presented. Patients with the transapical approach (n=575) suffered more comorbidities than transfemoral patients (n=463) with a significantly higher logistic EuroSCORE (29% versus 25.8%; P=0.007). These groups are different; therefore, outcomes cannot be directly compared. Total Kaplan Meier 1-year survival was 76.1% overall, 72.1% for transapical and 81.1% for transfemoral patients, and 73.5% of surviving patients were in New York Heart Association (NYHA) class I or II at 1 year. Combined transapical and transfemoral causes of death were cardiac in 25.1%, noncardiac in 49.2%, and unknown in 25.7%. Pulmonary complications (23.9%), renal failure (12.5%), cancer (11.4%), and stroke (10.2%) were the most frequent noncardiac causes of death. Multivariable analysis identified logistic EuroSCORE, renal disease, liver disease, and smoking as variables with the highest hazard ratios for 1-year mortality whereas carotid artery stenosis, hyperlipidemia, and hypertension were associated with lower mortality. Conclusion-: The SOURCE Registry is the largest consecutively enrolled registry for transcatheter aortic valve implantation procedures. It demonstrates that with new transcatheter aortic techniques excellent 1-year survival in high-risk and inoperable patients is achievable and provides a benchmark against which future transcatheter aortic valve implantation cohorts and devices can be measured. © 2011 American Heart Association, Inc.


Ndrepepa G.,Deutsches Herzzentrum | Schuster T.,Institution For Medizinische Statistik Und Epidemiologie | Hadamitzky M.,Deutsches Herzzentrum | Byrne R.A.,Deutsches Herzzentrum | And 9 more authors.
Circulation | Year: 2012

Background-: The Bleeding Academic Research Consortium (BARC) has recently proposed a unified definition of bleeding in patients receiving antithrombotic therapy. We investigated the relationship between bleeding events as defined by BARC and 1-year mortality in patients undergoing percutaneous coronary intervention (PCI) and assessed whether the BARC bleeding definition is superior to existing bleeding definitions in regard to mortality prediction in patients after PCI procedures. Methods and results-: This study represents a patient-level pooled analysis of 12 459 patients recruited in 6 randomized trials of patients undergoing PCI. Bleeding events were assessed with the use of BARC, Thrombolysis in Myocardial Infarction (TIMI), and Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE-2) trial criteria. The primary outcome was 1-year mortality. Bleeding occurred in 1233 patients (9.9%) according to BARC (679 patients or 5.4% with BARC class ≥2 bleeding), in 374 patients (3.0%) according to TIMI, and in 491 patients (3.9%) according to REPLACE-2 criteria. There were 340 deaths (2.7%) over the first year after PCI. BARC class ≥2 bleeding was associated with a significant increase in 1-year mortality (adjusted hazard ratio 2.72; 95% confidence interval, 2.03-3.63). The predictivity of a multivariable model for 1-year mortality was significantly improved after inclusion of bleeding defined according to BARC to an extent comparable to that provided by TIMI and REPLACE-2 criteria. CONCLUSIONS-: The present study demonstrated a close association between bleeding events defined according to BARC and 1-year mortality after PCI.© 2012 American Heart Association, Inc.


Kilner P.J.,Royal Brompton Hospital | Geva T.,Childens Hospital Boston | Kaemmerer H.,Deutsches Herzzentrum | Trindade P.T.,University of Zürich | 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.


Lahpor J.,University Utrecht | Khaghani A.,Harefield Hospital | Hetzer R.,Deutsches Herzzentrum | Pavie A.,Thoracic and Cardiovascular Surgery | And 3 more authors.
European Journal of Cardio-thoracic Surgery | Year: 2010

Objective: The HeartMate II (HM II) LVAD is a small, quiet, continuous-flow, left ventricular assist device (LVAD) for circulatory support in advanced heart-failure patients, with over 2000 implants worldwide. This article reports on the European experience with this device. Methods: The HM II was implanted in 571 patients at 64 European institutions. In 72% of cases (411 patients), implantation has taken place at least 6 months before the closing date of the study (1 August 2008). Patients (19% female, 70% ischaemic aetiology) were on maximum medical therapy, including inotropic support. Body surface area ranged from 1.30 to 2.50 m2 and age from 14 to 75 years (mean: 51 ± 14 years; n = 115, 28% over age 60 years). The intention of support was to provide a bridge to transplantation (73%), destination therapy (21%) and a bridge to recovery (6%). Adverse events were documented in the first 53 patients - for obtaining the Conformité Européenne (CE) Mark (group A) - from a European multicentric study (Strüber et al. [Strüber M, Sander K, Lahpor J, Ahn H, Litzler P-Y, Drakos SG, Musumeci F, Schlensak C, Friedrich I, Gustafsson R, Oertel F, Leprince P. HeartMate II left ventricular assist device; early European experience. Eur J Cardiovasc Surg 2008;34(2):289-94.]: 101 patients) and from a single-centre study (UMCU, The Netherlands: 30 patients). Results: The mean support duration ranged from 0 to 1019 days with a mean of 236 ± 214 days (249 patients: >6 months, 119: 1 year, 12: >2 years; total support time: 293 years). The overall survival to transplantation, recovery or ongoing device support at the end of the study was 69% (284) with an early mortality of 17.5% and late mortality of 13.5%. Of the surviving patients, 23% have been transplanted, 4% had their device removed after recovery of the left ventricle and 42% are still ongoing. Adverse events included bleeding (ranging from 42% in group C to 59% in group A), percutaneous lead infections (A: 0.19, B: 0.61 and C: 0.18 events per patient year), pocket infections (A: 0.08, B: 0.07 and C: 0.09 events per patient year), ischaemic stroke (A: 0.06, B: 0.09 and C: 0.04 events per patient year), haemorrhagic stroke (B: 0.07, C: 0.04 events per patient year) and transient ischaemic attacks (TIAs; A: 0.08, B: 0.02 and C: 0.13 events per patient year). Conclusions: These results support the use of the HM II continuous-flow LVAD for long-term support as a bridge to transplantation and possibly for destination therapy. Future emphasis should focus on minimising adverse events such as infections, bleeding and neurological events. © 2009 European Association for Cardio-Thoracic Surgery.


Kukucka M.,Deutsches Herzzentrum | Potapov E.,Deutsches Herzzentrum | Stepanenko A.,Deutsches Herzzentrum | Weller K.,Deutsches Herzzentrum | And 3 more authors.
Journal of Thoracic and Cardiovascular Surgery | Year: 2011

Objective: Left ventricular assist device (LVAD) implantation is an established option for treatment of patients with end-stage heart failure, but outcome may be worsened by right ventricular failure. The aim of this study was to evaluate the acute effect of LVAD on right ventricular geometry and function and the pulmonary circulation. The effect of inhaled nitric oxide (iNO) was assessed. Methods: We evaluated pre- and postoperatively obtained transesophageal echocardiography images and hemodynamics of patients participating in a randomized trial on the effect of inhaled nitric oxide during LVAD implantation. Twenty-four patients were randomized to the iNO group and 23 to the placebo group. Results: After LVAD implantation marked decreases in pulmonary capillary wedge pressure (P < .01) and mean pulmonary artery pressure (P < .01) were observed in both groups. Pulmonary vascular resistance decreased only in the iNO group (311 ± 35 to 225 ± 17, P < .01). Transesophageal echocardiography measurements show significant improvement of right ventricular geometry (right ventricular end-diastolic diameter: 50 ± 2 to 45 ± 2, P < .01 and 48 ± 2 to 44 ± 2 mm, P < .05 in iNO and placebo groups) and function (right ventricular fractional area change: 24% ± 2% to 31% ± 2%, P < .05 and 23% ± 2% to 29% ± 2%, P < .05 in iNO and placebo groups) without any difference between the iNO and placebo groups. The overall incidence of postoperative right ventricular failure was 4 of 47 (8.5%). Conclusions: LVAD implantation markedly improved right ventricular geometry and function in most of the patients, probably by resolving left ventricular congestion and thus reducing right ventricular afterload. Beneficial effects of iNO may have been masked by more pronounced consequences of left ventricular unloading on right ventricular function. © 2011 by The American Association for Thoracic Surgery.


Bernlochner I.,Deutsches Herzzentrum | Sibbing D.,Deutsches Herzzentrum
Handbook of Experimental Pharmacology | Year: 2012

Platelet P2Y12 receptor inhibition plays a pivotal role in preventing thrombotic vascular events in patients with ACS and in patients undergoing percutaneous coronary intervention (PCI). Among the P2Y12 receptor inhibitors, the group of thienopyridines include ticlopidine, clopidogrel and prasugrel, all of which are orally administered prodrugs leading to irreversible P2Y12 receptor inhibition. Non-thienopyridine derivatives including ticagrelor, cangrelor and elinogrel do not require metabolic activation and lead to a reversible P2Y12 receptor inhibition in contrast to thienopyridines. The extend of platelet inhibition is subject to the administered antiplatelet agent and influenced by individual genetic and clinical factors. Insufficient platelet inhibition, termed high platelet reactivity (HPR) is associated with an increased risk for ischemic events after PCI whereas exceeding platelet inhibition results in an increased bleeding risk. Pharmacologic properties and clinical outcome data differ substantially between the existing P2Y12 receptor inhibitors. Whether individualized antiplatelet treatment incorporating different P2Y12 receptor inhibitors improves patients' clinical outcomes warrants further investigation. © 2012 Springer-Verlag Berlin Heidelberg.

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