Hendrik Treede

University of Hamburg, Hamburg, Hamburg, Germany

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Publications (165)511.09 Total impact

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    ABSTRACT: Acquired von Willebrand syndrome (aVWS) is a common complication of severe aortic valve stenosis and can be corrected by surgical valve replacement. Transcatheter aortic valve implantation (TAVI) is gaining importance, but the influence of this new technique on aVWS has never been examined. The objective of this study was to assess the impact of TAVI on aVWS. We enrolled 15 patients with severe aortic stenosis and high surgical risk admitted for elective TAVI. All patients were successfully treated by TAVI, using either the transfemoral (n = 6) or transapical approach (n = 9). Patients were screened for aVWS by measuring PFA-100 in vitro closure time, von Willebrand factor (VWF) antigen, VWF function, and VWF multimer analysis. Analyses were then repeated 30 minutes, 24 hours, and 7 days after valve replacement. Fourteen of 15 patients showed pathologic alterations of VWF. An inverse correlation was observed between the transvalvular pressure gradient and VWF high-molecular-weight multimers (VWF:HMWM) (r = -0.621; P=.01), which are essential for the platelet dependent hemostatic function of VWF. Transaortic gradient was significantly reduced in all patients following TAVI. Hemostaseologic findings improved in all patients following TAVI, the percentage of VWF:HMWM increased (19.05 ± 5.19% before TAVI to 24.08 ± 4.75% (P=.04) on day 7 post TAVI), and the multimer pattern normalized. Acquired von Willebrand syndrome due to aortic valve stenosis can successfully be corrected by TAVI.
    The Journal of invasive cardiology 12/2014; 26(12):654-658. · 1.57 Impact Factor
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    ABSTRACT: The novel ACURATE TA™ transcatheter aortic valve (Symetis, Ecublens, Switzerland) is composed of a self-expanding nitinol stent covered by an anti-paravalvular leak skirt designed for transapical implantation. Since Conformite Europeenne (CE)-mark approval, the first 250 patients implanted with the newly approved device have been included in this post-market, multicentre registry. The registry was conducted at 17 sites in Germany, Italy, Switzerland and Argentina to treat 250 high-risk elderly patients. This all-comers population presented preoperatively with a mean aortic gradient of 43.2 ± 17.4 mmHg, mean age of 80.9 ± 6.3 years, mean society of thoracic surgeons risk score of 8.0 ± 5.9% and mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 22.3 ± 12.7%. The majority of patients (93%) were in New York Heart Association (NYHA) class III/IV. All patients were treated within a multidisciplinary Heart Team. The procedural success rate was 98% (n = 245) with two valve-in-valve procedures and three conversions to conventional surgery. The 30-day mortality rate was 6.8%. Postimplant echocardiography revealed a relevant paravalvular leak (moderate 2+) in 2.3% of patients, with all other patients demonstrating either none/trace or a 1+ leak. The 30-day stroke rate was 2.8% and the mean transvalvular gradient was 12.4 ± 5.8 mmHg. A new pacemaker implantation was required in 10.0% of patients and 85% of patients returning for the follow-up presented in NYHA class I/II. The short-term result of the registry shows a safety and efficacy profile comparable, if not improved in some aspects, with previously approved transcatheter aortic valve implantation devices. These 'real-world' data highlight an excellent functional outcome, especially in regard to a low rate of relevant paravalvular leak. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
    European journal of cardio-thoracic surgery: official journal of the European Association for Cardio-thoracic Surgery 11/2014; · 2.40 Impact Factor
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    ABSTRACT: The SAPIEN 3 (Edwards Lifesciences Inc., Irvine, California) transcatheter valve incorporates features designed to address the well-known deficiencies of transcatheter aortic valve replacement (TAVR). An ultra–low-profile delivery system facilitates safe, controlled, and accurate implantation and an external seal minimizes paravalvular regurgitation.Objectives The study evaluated whether TAVR with this third-generation valve would be a viable alternative to high- or intermediate-risk surgery for severe aortic stenosis.Methods The prospective study enrolled 150 patients at 16 sites in Europe and Canada. Clinical and echocardiographic outcomes were assessed at baseline, post-procedure, and 30 days. New sizing recommendations were developed during the course of the study.ResultsPatients were 83.6 ± 5.0 years of age, with multiple comorbidities reflected by a Society of Thoracic Surgeons score of 7.4 ± 4.5% and logistic EuroSCORE of 21.6 ± 12.3%. A transfemoral approach was chosen in 64.0% and alternative access (transapical/direct aortic) in the remainder. At 30 days, paravalvular regurgitation was none to mild in 96.4% and moderate in 3.5%. No patient had severe regurgitation. Transfemoral implantation was associated with low mortality (2.1%), no disabling stroke (0.0%), and fully percutaneous access and closure in 95.8%. Nontransfemoral alternative access was associated with higher rates of mortality (11.6%) and stroke (5.6%).Conclusions This third-generation device addresses major deficiencies of earlier valves in terms of ease of use, accuracy of positioning, and paravalvular sealing. The rates of mortality and stroke with transfemoral access are among the lowest reported and support further evaluation as an alternative to open surgery in intermediate-risk patients. (Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve [SAPIEN3]; NCT01808287)
    Journal of the American College of Cardiology 11/2014; · 14.09 Impact Factor
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    ABSTRACT: Minimally-invasive left ventricular assist device (LVAD) implantation with the HVAD has been reported lately as an alternative approach to median sternotomy due to its favorable results regarding sternal wound complications, mediastinitis, postoperative bleeding and right ventricular failure (RVF).Relevant aortic regurgitation is a cardiac comorbidity that requires surgical repair at the time of LVAD implantation to reduce recirculation and ensure adequate forward flow. We herein report on a patient with severely reduced left ventricular function due to ischemic cardiomyopathy, moderate aortic regurgitation and a reduced right ventricular function. We performed minimally-invasive HVAD implantation with concomitant transapical transcatheter aortic valve replacement (TAVR). We believe this hybrid procedure could potentially reduce the risk for post-LVAD RVF, because it preserves the pericardial geometry and obviates the need for cardioplegic arrest.
    ASAIO journal (American Society for Artificial Internal Organs: 1992) 11/2014; · 1.39 Impact Factor
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    ABSTRACT: Minimally invasive surgical procedures (MIS) may offer several advantages over conventional full sternotomy (FS) aortic valve replacement (AVR). A novel class of aortic valve prostheses has been developed for rapid-deployment AVR (RDAVR). We report a randomized, multicenter trial comparing the outcomes for MIS-RDAVR with those of conventional FS-AVR. A total of 100 patients with aortic stenosis were enrolled in a prospective, multicenter, randomized comparison trial (CADENCE-MIS). Exclusion criteria included ejection fraction below 25%, AVR requiring concomitant procedures, and recent myocardial infarction or stroke. Patients were randomized to undergo MIS-RDAVR through an upper hemisternotomy (n = 51) or AVR by FS with a conventional stented bioprosthesis (n = 49). Three patients were excluded before the procedure, and 3 more patients who were randomized to undergo RDAVR were excluded because of their anatomy. Procedural, early clinical outcomes, and functional outcomes were assessed for the remaining 94 patients. Hemodynamic performance was assessed by an echocardiography core laboratory. Implanted valve sizes were similar between groups (22.9 ± 2.1 vs 23.0 ± 2.1 mm, p = 0.9). MIS-RDAVR was associated with significantly reduced aortic cross-clamp times compared with FS-AVR (41.3 ± 20.3 vs 54.0 ± 20.3 minutes, p < 0.001), although cardiopulmonary bypass times were similar (68.8 ± 29.0 vs 74.4 ± 28.4 minutes, p = 0.21). Early clinical outcomes were similar between the two groups, including quality of life measures. The RDAVR patients had a significantly lower mean transvalvular gradient (8.5 vs 10.3 mm Hg, p = 0.044) and a lower prevalence of patient-prosthesis mismatch (0% vs 15.0%, p = 0.013) 3 months postoperatively compared with the FS-AVR patients. RDAVR by the MIS approach is associated with significantly reduced myocardial ischemic time and better valvular hemodynamic function than FS-AVR with a conventional stented bioprosthesis. Rapid deployment valves may facilitate the performance of MIS-AVR. Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
    The Annals of thoracic surgery. 11/2014;
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    ABSTRACT: This prospective single-center study aimed to determine the responsiveness and diagnostic performance of continuous cardiac output (CCO) monitors based on pulse contour analysis compared with invasive mean arterial pressure (MAP) during predefined periods of acute circulatory deterioration in patients undergoing transcatheter aortic valve implantation (TAVI). The ability of calibrated (CCOCAL) and self-calibrated (CCOAUTOCAL) pulse contour analysis to detect the hemodynamic response to 37 episodes of balloon aortic valvuloplasty enabled by rapid ventricular pacing was quantified in 13 patients undergoing TAVI. A "low" and a "high" cut-off limit were predefined as a 15 or 25 % decrease from baseline respectively. We found no significant differences between CCOCAL and MAP regarding mean response time [low cut-off: 8.6 (7.1-10.5) vs. 8.9 (7.3-10.8) s, p = 0.76; high cut-off: 11.4 (9.7-13.5) vs. 12.6 (10.7-14.9) s, p = 0.32] or diagnostic performance [area under the receiver operating characteristics curve (AUC): 0.99 (0.98-1.0) vs. 1.0 (0.99-1.0), p = 0.46]. But CCOCAL had a significantly higher amplitude response [95.0 (88.7-98.8) % decrease from baseline] than MAP [41.2 (30.0-52.9) %, p < 0.001]. CCOAUTOCAL had a significantly lower AUC [0.83 (0.73-0.93), p < 0.001] than MAP. Moreover, CCOCAL detected hemodynamic recovery significantly earlier than MAP. In conclusion, CCOCAL and MAP provided equivalent responsiveness and diagnostic performance to detect acute circulatory depression, whereas CCOAUTOCAL appeared to be less appropriate. In contrast to CCOCAL the amplitude response of MAP was poor. Consequently even small response amplitudes of MAP could indicate severe decreases in CO.
    Journal of clinical monitoring and computing. 10/2014;
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    ABSTRACT: Objectives: We sought to evaluate the relationship of blood transfusion after transcatheter aortic valve implantation (TAVI) and mid-term outcome to improve patient selection and periprocedural treatment.Background: Increasing evidence suggests a negative influence of blood transfusion on outcomes of patients with cardiovascular diseases. While the adverse impact of bleeding events on survival has been documented after TAVI, data on the impact of postoperative blood transfusions are scarce.Methods: TAVI was performed in 700 consecutive patients. 14.7% of TAVI patients suffered from bleeding or access site complications and were excluded from analysis to minimize confounding. Outcomes were analyzed with emphasis on blood transfusions and according to the Valve Academic Research Consortium definitions. Median follow-up duration was 364 days. Multivariable analyses were performed to identify predictors for transfusion and 1-year mortality.Results: 33.0% of patients received blood transfusions after TAVI, irrespective of access choice. Blood transfusions were associated with a higher baseline risk profile (median logistic EuroSCORE 21.0 vs. 17.0%), increased rates of postoperative complications and impaired survival (21.2 vs. 36.1% all-cause 1-year mortality). Transfusion was an independent predictor of mortality at 1 year (OR 2.78 [CI 1.59-4.86]). Low body mass index (OR 0.94 [0.89-1.0]), low baseline hemoglobin (OR 0.39 [0.33-0.47]) and combined anticoagulation/antiplatelet therapy were identified as independent predictors of blood transfusion after TAVI.Conclusions: Blood transfusions were frequently required after TAVI even in the absence of overt bleeding or access site complications and were identified as an independent predictor of impaired mid-term outcome. Optimization of baseline factors, strict blood conservation strategies and individualized antiplatelet or anticoagulant regimens may improve outcome after TAVI. © 2014 Wiley Periodicals, Inc.
    Catheterization and Cardiovascular Interventions 10/2014; · 2.51 Impact Factor
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    ABSTRACT: Background The logistic European System for Cardiac Operative Risk Evaluation (logEuroSCORE) II was developed to improve prediction of mortality in cardiac surgery. However, no specific tools are available for risk prediction in transcatheter aortic valve implantation (TAVI). The recently introduced EuroSCORE II was compared with established risk scores. Patients and Methods We assessed 457 consecutive patients (80.5 ± 7.1 years, 52.3% female) undergoing TAVI. Preoperative risk evaluation included logEuroSCORE I, EuroSCORE II, Society of Thoracic Surgeons (STS), Ambler, and Parsonnet scores. Validity was assessed by receiver-operating characteristic (ROC) and area under the curve (AUC). Results A 30-day mortality was 9.6% (44/457). Calculated scores were logEuroSCORE I 22.0%, confidence interval (CI) 21.0 to 24.6; EuroSCORE II 7.0%, CI 6.4 to 8.1; STS 7.9%, CI 7.7 to 9.5; Ambler score 6.9%, CI 5.7 to 7.0; and Parsonnet score 23.8%, CI 20.9 to 24.1. ROC analyses demonstrated no predictive value: logEuroSCORE I AUC 0.56, CI 0.47 to 0.65; EuroSCORE II AUC 0.54, CI 0.46 to 0.63; STS AUC 0.57, CI 0.49 to 0.66; Ambler AUC 0.52, CI 0.43 to 0.60; and Parsonnet AUC 0.51, CI 0.43 to 0.60. Accuracy and thresholds were measured on behalf of Youden index. Accuracy ranged between 44.2% (Parsonnet) and 66.3% (logEuroSCORE I). Thresholds were logEuroSCORE I 26%, EuroSCORE II 7%, STS 6%, Ambler 3%, and Parsonnet 19%. Conclusions No risk evaluation system provided acceptable predictive ability. Scores derived from conventional cardiac surgery failed in risk prediction for TAVI. Specific risk tools are required. Until available, estimation of risk has to rely on judgment of an interdisciplinary heart team regarding individual patient factors.
    The Thoracic and Cardiovascular Surgeon 09/2014; · 0.93 Impact Factor
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    ABSTRACT: 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.
    JACC Cardiovascular Interventions 08/2014; 7(10):1168-74. · 7.42 Impact Factor
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    ABSTRACT: Owing to a considerable shift toward bioprosthesis implantation rather than mechanical valves, it is expected that patients will increasingly present with degenerated bioprostheses in the next few years. Transcatheter aortic valve-in-valve implantation is a less invasive approach for patients with structural valve deterioration; however, a comprehensive evaluation of survival after the procedure has not yet been performed.
    JAMA The Journal of the American Medical Association 07/2014; 312(2):162-70. · 29.98 Impact Factor
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    ABSTRACT: Chronic lung allograft dysfunction (CLAD), predominantly manifest as bronchiolitis obliterans syndrome (BOS), is the primary cause of morbidity and death after lung transplantation. We assessed the efficacy and safety of 2 de novo immunosuppression protocols to prevent BOS.
    06/2014;
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    ABSTRACT: Background Transcatheter aortic valve implantation (TAVI) has become routine for the treatment of high-risk patients with aortic stenosis. We assessed safety and feasibility of a left ventricular apical access and closure device combined with second-generation transapical (TA) TAVI transcatheter heart valves (THV). Methods and Results Three elderly, comorbid patients (logEuroSCORE I 13.0-31.1%) received transapical aortic valve implantation (TA-AVI) via the Apica ASC device (Apica Cardiovascular Ltd., Galway, Ireland) using second-generation THV (Medtronic Engager [Medtronic 3F Therapeutics, Santa Ana, California, United States], JenaValve [JenaValve Technology GmbH, Munich, Germany], Symetis Acurate [Symetis S.A., Ecublens, Switzerland]). Access was gained using a non-rib-spreading technique and a novel access and closure device. THV deployment was successful with excellent hemodynamic outcome (no PVL, n = 2; trace PVL, n = 1; mean transvalvular gradients, 5-19 mm Hg) and complete apical hemostasis. No periprocedural major adverse events occurred and Valve Academic Research Consortium-2-defined composite end point of device success was met in all cases. Conclusion Safety and feasibility of TA-AVI using the ASC device with second-generation THV was demonstrated. Combining latest available technology is a major step toward improved functional outcome and decreased surgical trauma in TA-AVI. Potentially, technical enhancements may eventually pave the way toward a fully percutaneous TA-AVI procedure.
    The Thoracic and cardiovascular surgeon. 06/2014;
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    ABSTRACT: Objectives We aimed at identifying predictors of renal impairment and its impact on long-term outcome after transcatheter aortic valve implantation (TAVI).Background Renal impairment is common in mostly elderly, multimorbid patients undergoing TAVI. The risk of periprocedural renal function impairment and its association with outcome is incompletely understood.Methods In 458 consecutive patients (mean age 80.6±7.0 years, 52.2% women) who underwent routine TAVI procedures we assessed estimated glomerular filtration rate (eGFR) at baseline, during 72 hours post procedure and at discharge. Over a median follow-up of 0.96 years we observed 142 deaths.ResultsIn multivariable-adjusted models, predictors of renal function deterioration within 72 hours were baseline eGFR (beta 0.83, 95% confidence interval [CI] 0.76/0.91; P<0.0001), body-mass-index (beta -1.20, 95% CI -1.77/-0.62; P<0.0001), and major access site complications (beta -14.82, 95% CI -26.52/-3.11; P=0.013) including bleeding (beta -11.97, 95% CI -21.05/-2.89; P=0.0099). Strongest renal function predictor of 1-year mortality in risk factor adjusted analyses was the change of eGFR within 72 hours (odds ratio 0.97, 95% CI 0.96/0.98; P<0.0001). The addition of information on the change of eGFR increased the C-statistic of the logistic EuroSCORE (P=0.021).Conclusions In our routine TAVI sample baseline eGFR, body-mass-index, and major access site complications mainly due to bleeding were correlates of acute kidney injury after TAVI. Acute renal impairment was a risk factor for mortality and adverse cardiovascular events which provided risk information beyond the EuroSCORE. © 2014 Wiley Periodicals, Inc.
    Catheterization and Cardiovascular Interventions 06/2014; · 2.51 Impact Factor
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    ABSTRACT: Aims: Recently, the feasibility of valve-in-valve procedures using current first-generation transcatheter heart valves (THV) in cases of structural valve degeneration has been reported as an alternative to conventional open repeat valve replacement. By design, certain biological valve xenografts carry a high risk of coronary ostia occlusion due to lateral displacement of leaflets after valve-in-valve procedures. In the present report we aimed to prove feasibility and safety of transapical valve-in-valve implantation of the JenaValve THV in two cases of degenerated Mitroflow bioprostheses. Methods and results: We herein report two cases of successful transapical valve-in-valve procedures using a JenaValve THV implanted in Sorin Mitroflow bioprostheses for structural valve degeneration. Both patients were alive and in good clinical condition at 30 days from the procedure. However, increased transvalvular gradients were noted in both cases. Conclusions: Transcatheter valve-in-valve implantation of a JenaValve THV is a valid alternative for patients with degenerated Mitroflow bioprostheses of sufficient size and in the presence of short distances to the coronary ostia who are too ill for conventional repeat open heart surgery. Increased pressure gradients have to be expected and weighed against the disadvantages of other treatment options when planning such a procedure.
    EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 03/2014; · 3.17 Impact Factor
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    ABSTRACT: Transcatheter aortic valve implantation (TAVI) is an increasingly common procedure in elderly and multimorbid patients with aortic stenosis. We aimed at developing a pre-procedural risk evaluation scheme beyond current surgical risk scores. We developed a risk algorithm for 1-year mortality in two cohorts consisting of 845 patients undergoing routine TAVI procedures by commercially available devices, mean age 80.9 ± 6.5, 51 % women. Clinical variables were determined at baseline. Multivariable Cox regression related clinical data to mortality (n = 207 deaths). To account for variability related to age and sex and by enrolment site we forced age, sex, and cohort into the score model. Body mass index, estimated glomerular filtration rate, hemoglobin, pulmonary hypertension, mean transvalvular gradient and left ventricular ejection fraction at baseline were most strongly associated with mortality and entered the risk prediction algorithm [C-statistic 0.66, 95 % confidence interval (CI) 0.61-0.70, calibration χ (2)-statistic = 6.51; P = 0.69]. Net reclassification improvement compared to existing surgical risk predication schemes was positive. The score showed reasonable model fit and calibration in external validation in 333 patients, N = 55 deaths (C-statistic 0.60, 95 % CI 0.52-0.68; calibration χ (2)-statistic = 16.2; P = 0.06). Additional measurement of B-type natriuretic peptide and troponin I did not improve the C-statistic. Frailty increased the C-statistic to 0.71, 95 % CI 0.65-0.76. We present a new risk evaluation tool derived and validated in routine TAVI cohorts that predicts 1-year mortality. Biomarkers only marginally improved risk prediction. Frailty increased the discriminatory ability of the score and needs to be considered. Risk algorithms specific for TAVI may help to guide decision-making when patients are evaluated for TAVI.
    Clinical Research in Cardiology 03/2014; · 3.67 Impact Factor
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    ABSTRACT: Transcatheter aortic valve implantation (TAVI) has become an established procedure in patients with aortic stenosis and high surgical risk. Experience with first-generation transcatheter heart valves (THVs) is broad but limitations, e.g. paravalvular regurgitation, have been demonstrated. Much hope rests on the recently Conformité Européenne mark approved next-generation devices to improve results in these patients. However, apart from the initial approval studies, clinical data with these new devices are still scarce. We aimed to assess short-term outcomes of 200 consecutive patients who underwent transapical TAVI with next-generation THV at our institution. Transapical TAVI was performed in 200 consecutive patients 80.5 ± 6.7 years old (38.5% female) at high surgical risk (log EuroSCORE 20.2 ± 16.5%). Devices implanted were the Engager (Medtronic, Inc., Minneapolis, MN, USA; n = 50), JenaValve (JenaValve Technology, Munich, Germany; n = 88) and Symetis Acurate (Symetis SA, Ecublens, Switzerland; n = 62) THV that were selected by the heart team on an individual basis. Data at baseline, during the procedure and follow-up were analysed according to standardized Valve Academic Research Consortium end points. Median follow-up was 219 days. Implantation was successful in 96.5% of cases. Valve function improved significantly with an increase in effective orifice area from 0.8 ± 0.4 to 1.8 ± 0.3 cm(2) and a reduction in mean transvalvalvular gradients from 34.0 ± 17.0 to 11.2 ± 5.4 mmHg. Paravalvular regurgitation was none or trace in 70.3% of patients, Grade 1 in 26.1%, and Grade 2 in 3.5%. No patients developed aortic regurgitation > Grade 2. Major access site complications occurred in 6.5%, major stroke in 1.5% and stage-3 kidney injury in 2.5% of patients. A permanent pacemaker was implanted in 20.5% of patients overall and in 8.0% for a complete heart block. At 30-day follow-up 72.8% of patients were in New York Heart Association class I or II (10.5% at baseline). Overall survival was 91.5% at 30 days and 73.9% at 1 year. In a real-world clinical setting, next-generation transapical THV yielded positive haemodynamic results. The incidence of relevant paravalvular regurgitation was scarce in this group and clinical outcomes were encouraging during short-term follow-up. Long-term follow-up is required to investigate the durability of these new devices.
    European journal of cardio-thoracic surgery: official journal of the European Association for Cardio-thoracic Surgery 02/2014; · 2.40 Impact Factor
  • The Thoracic and Cardiovascular Surgeon 02/2014; 62(S 01). · 0.93 Impact Factor
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    ABSTRACT: Background chronic lung allograft dysfunction (CLAD), predominantly manifest as bronchiolitis obliterans syndrome (BOS), is the primary cause of morbidity and mortality after lung transplantation (LTX). We assessed the efficacy and safety of two de- novo immunosuppression protocols to prevent BOS Methods multicenter prospective international randomized (1:1) open label superiority study of de-novo enteric coated mycophenolate sodium (MPS) versus delayed onset everolimus (RAD), both arms in combination with cyclosporine (CsA) monitored by two hour post dose (C2) levels and corticosteroids. Target C2 levels were lower in the RAD group as RAD is known to potentiate CsA nephrotoxicity. Cytolytic induction therapy was not employed. Patients were stratified at entry for cystic fibrosis. Confirmation of anastomotic healing was required for randomization. Primary efficacy was freedom from BOS ≥1 on intention-to-treat analysis (ITT). Secondary efficacy parameters were patient and graft survival and severity of rejection. Treatment failure was defined by graft loss, patient death, drug cessation or need for other therapy. Results 3-year freedom from BOS ≥1 for MPS (n=80) vs RAD (n=84) was 70% vs 71% (p = 0.95, log rank) in ITT but was lower in the RAD arm of the per protocol population (p=0.03). 3-year survival was 84% (MPS) vs 76% (RAD), (p = 0.19, log rank). 13 patients switched from MPS vs 31 from RAD (p<0.01). Days on MPS were greater than days on RAD (p<0.01). Biopsy proven rejection events were more common on MPS (p=0.02) as were leucopenia (p<0.01), diarrhea (p<0.01) and CMV infection (p=0.04). Venous thromboembolism was more frequent on RAD (p=0.02). Creatinine at 3-years was 160±112 µmol/l MPS vs 152±98 µmol/l RAD, p=0.67. Conclusions This 3-year ITT analysis found no significant difference between arms but was underpowered to accept the null hypothesis that RAD and MPS have equivalent efficacy in preventing BOS or death after LTX.
    The Journal of Heart and Lung Transplantation. 01/2014;
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    ABSTRACT: The Medtronic Engager aortic valve system is a second-generation transcatheter aortic valve implantation bioprosthesis combined with a delivery system designed for over-the-wire transapical implantation of the valve. The self-expandable stent has control arms to be placed into the native aortic sinuses to achieve correct positioning of the bioprosthesis in a predefined height. The purpose of the lower skirt is to reduce paravalvular leakage. A three-leaflet, bovine pericardium valve is mounted on the stent. The implantation is facilitated by the control arms and rotational positioning of the commissural posts. A multicentre feasibility study showed promising results. The results from the following European pivotal trial led to CE mark approval in 2013. Here, we describe technical details of the device and its implantation technique and highlight special steps of the procedure.
    Multimedia Manual of Cardiothoracic Surgery 01/2014; 2014:mmu001.
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    ABSTRACT: Objectives The aim of the study was to assess predictors of acute procedural failure in surgical high-risk patients undergoing MitraClip (Abbott Vascular, Abbott Park, Illinois) therapy. Background MitraClip implantation is a novel percutaneous option to treat significant mitral regurgitation (MR). Methods In 300 patients (75 ± 9 years of age, 190 [63%] men), of whom 32 (10.7%) had been unsuccessfully treated (discharge MR grade of >2+), baseline clinical and echocardiographic variables were evaluated by exact logistic regression and classification tree analyses to assess their impact on acute procedural failure. Acute procedural failure was differentiated into aborted procedure (no MitraClip implanted; n = 11) and “clip failure” (inadequate MR reduction despite MitraClip implantation; n = 21). Results Multivariate logistic regression identified effective regurgitant orifice area (EROA), mitral valve orifice area (MVOA), and mean transmitral pressure gradient (TMPG) as independent predictors of overall acute procedural failure. Classification tree analysis revealed that an EROA >70.8 mm2 (n = 28) was associated with a high rate (25%) of clip failures, whereas the combination of an MVOA ≤3.0 cm2 and a TMPG ≥4 mm Hg (n = 16) was associated with a high rate (37.5%) of aborted procedures. Failure rates of ≤10% were observed in all patients with an EROA ≤70.8 mm2 and either an MVOA >3.0 cm2 (n = 217) or an MVOA ≤3.0 cm2 in concert with a TMPG ≤3 mm Hg (n = 39). Multinomial logistic regression identified an EROA >70.8 mm2 and a TMPG ≥4 mm Hg as independently predictive of clip failure, but an MVOA ≤3.0 cm2 and a TMPG ≥4 mm Hg as independently predictive of procedure abortion. Conclusions In surgical high-risk patients undergoing MitraClip therapy, a TMPG ≥4 mm Hg, an EROA ≥70.8 mm2, and an MVOA ≤3.0 cm2 carry an increased risk of procedural failure.
    JACC Cardiovascular Interventions 01/2014; · 7.42 Impact Factor

Publication Stats

2k Citations
511.09 Total Impact Points

Institutions

  • 2003–2014
    • University of Hamburg
      • • Department of Cardiovascular Surgery
      • • University Heart Center
      Hamburg, Hamburg, Germany
  • 2013
    • University of Zurich
      • Department of Cardiovascular Surgery
      Zürich, Zurich, Switzerland
    • Kunststoff-Zentrum in Leipzig
      Leipzig, Saxony, Germany
  • 2012–2013
    • University of Cologne
      Köln, North Rhine-Westphalia, Germany
    • King’s Health Partners
      Londinium, England, United Kingdom
    • Kerckhoff Klinik
      Stadt Bad Nauheim, Hesse, Germany
  • 2003–2013
    • University Medical Center Hamburg - Eppendorf
      • • Department of Anaesthesiology
      • • Department of Cardiovascular Surgery
      Hamburg, Hamburg, Germany
  • 1999–2012
    • Ludwig-Maximilian-University of Munich
      • • Cardiac Surgery Clinic
      • • Department of Clinical Radiology
      • • Clinic of Cardiac Surgery
      München, Bavaria, Germany
  • 2011
    • University of Duisburg-Essen
      Essen, North Rhine-Westphalia, Germany
    • Erasmus Universiteit Rotterdam
      • Department of Cardio-Thoracic Surgery
      Rotterdam, South Holland, Netherlands
  • 2010
    • National Health Service
      • Department of Cardiothoracic Surgery
      Radditch, England, United Kingdom