Bioprosthetic valve fracture: Predictors of outcome and follow-up. Results from a multicenter study.

Objectives: To evaluate outcome and its predictors of bioprosthetic valve fracture (BVF) in patients undergoing valve-in-valve transcatheter aortic valve replacement (VIV-TAVR).

Background: BVF is feasible and reduces transvalvular gradients in VIV-TAVR-procedures, but follow-up-data and information on factors influencing the outcome are missing.

Methods: The 81 cases of BVF-VIV-TAVR were collected from 14 international centers.

The Freestyle Valve in Severe Necrotizing Aortic Root Endocarditis: Comorbidity Upon Outcome.

Background: Treatment of severe necrotizing aortic root endocarditis (SNARE) carries a substantial perioperative risk. As an alternative to homografts, we assessed short-term outcome and future prognosis in patients undergoing root replacement using the Freestyle valve.

Methods: Between 2000 and 2018, a total of 45 patients (mean age 70.

Comparison of intraoperative versus intraoperative plus postoperative hemoadsorption therapy in cardiac surgery patients with endocarditis.

Infective endocarditis is caused by a bacterial infection of the endocardial surface, and despite improvements in surgical interventions and antimicrobial therapy, mortality remains high. Recently published data suggest that intraoperative hemoadsorption therapy might represent a promising treatment option; however, randomized data still lack, and a comparative study on the intraoperative versus intraoperative plus postoperative use of CytoSorb has not yet been performed. We hypothesized that patients developing intraoperative renal failure benefit from additional postoperative CytoSorb treatment in terms of outcome.

Five-Year Outcome After Off-Pump or On-Pump Coronary Artery Bypass Grafting in Elderly Patients.

Background: The 30-day and 1-year follow-up analysis of the GOPCABE trial (German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients) revealed no significant difference in the composite end point consisting of death, stroke, myocardial infarction, new renal replacement therapy, or repeat revascularization. The 5-year follow-up data of this trial are reported here.

Methods: From June 2008 to September 2011, a total of 2539 patients aged ≥75 years were randomly assigned to undergo off-pump or on-pump coronary artery bypass grafting (CABG) at 12 centers in Germany.

Six-Month Performance of a 3-Dimensional Annuloplasty Ring for Repair of Functional Tricuspid Regurgitation.

Background: Functional tricuspid regurgitation (FTR) secondary to left-sided heart disease may lead to poor quality of life and reduced long-term survival. This study evaluated clinical and functional outcomes of patients undergoing tricuspid valve (TV) repair using a rigid three-dimensional ring (Contour 3D, Medtronic) concomitant with another procedure.

Methods: From September 2011 to July 2015, 112 patients (mean age 70.

Off-Pump Coronary Artery Bypass Grafting and Stroke-Exploratory Analysis of the GOPCABE Trial and Methodological Considerations.

Background: Coronary artery bypass grafting (CABG) without cardiopulmonary bypass (off-pump CABG) may reduce severe adverse events including stroke.

Methods: In the German Off-Pump Coronary Artery Bypass Grafting in Elderly patients trial, the rate of major adverse cardiovascular events was compared in 2,394 elderly (≥ 75 years) patients undergoing CABG with (on-pump) or without (off-pump) cardiopulmonary bypass. This exploratory post-hoc analysis investigated the impact of surgical aortic manipulation on the rate of stroke.

Performance of the Evolut-R 34 mm versus Sapien-3 29 mm in Transcatheter aortic valve replacement patients with larger annuli: Early outcome results of Evolut-R 34 mm as compared with Sapien-3 29 mm in patients with Annuli ≥26 mm.

Background: Evolut-R 34 mm (received CE mark in January 2017) and Sapien-3 29 mm are the only options for transcatheter aortic valve replacement (TAVR) in patients with annulus ≥26 mm. We compared the short-term outcomes of these valves in these patients.

Methods: Data was collected prospectively from consecutive patients with severe aortic stenosis and annulus diameter larger than 26 mm treated by femoral approach TAVR.

Long-Term Outcomes of the Mosaic Bioprosthesis.

Background: The Mosaic bioprosthesis is a third-generation stented porcine bioprosthesis. This study was performed to evaluate long-term survival and durability associated with this device.

Methods: A total of 1,029 patients (797 aortic valve replacements, 232 mitral valve replacements) previously enrolled at 6 centers as part of the original regulatory study were included.

Complete arterial revascularization using bilateral internal mammary artery in T-graft technique for multivessel coronary artery disease in on- or off-pump approach: does gender lose its historical impact on clinical outcome?

Objectives: Higher rates of mortality and morbidity have been reported in women undergoing coronary artery bypass grafting (CABG) compared with men. Different revascularization techniques (on-pump and off-pump) might influence this outcome.

Methods: We retrospectively analysed 3445 consecutively recruited patients (all comers) undergoing complete arterial CABG (CACABG) at a single centre between January 2000 and December 2012.

Tricuspid regurgitation is a predictor of mortality after percutaneous mitral valve edge-to-edge repair.

Aims: The aim of this study was to determine the impact of tricuspid regurgitation (TR) on mortality after edge-to-edge percutaneous mitral valve repair (PMVR), and also to analyse whether there is a difference in outcome between patients with improvement of TR after PMVR compared to patients without.

Methods And Results: Out of 197 consecutive patients who underwent PMVR, 139 patients with available follow-up (mean 428±386 days) were included in the study. Concomitant moderate/severe TR was present in 58.

On-Pump versus Off-Pump Complete Arterial Revascularization Using Bilateral Internal Mammary Arteries and the T-Graft Technique: Clinical and Angiographic Results for 3,445 Patients in 13 Years of Follow-Up.

Background: This is an investigation of complete arterial coronary artery bypass grafting (CACABG) using bilateral internal mammary arteries (IMA) and the T-graft technique either on- or off-pump as a routine approach to treat coronary artery disease.

Methods: Between January 2000 and December 2012, 3,445 patients underwent on-pump (n = 2,216) or off-pump (n = 1,229) CACABG. A 30-day follow-up was performed prospectively, a long-term follow-up by a questionnaire, and coronary angiography in selected patients.

Transfemoral Implantation of a Fully Repositionable and Retrievable Transcatheter Valve for Noncalcified Pure Aortic Regurgitation.

Objectives: This study sought to evaluate the use of the Direct Flow Medical (DFM) transcatheter heart valve (Direct Flow Medical, Santa Rosa, California) for the treatment of noncalcific pure aortic regurgitation (AR).

Background: The treatment of noncalcific AR has remained a relative contraindication with transcatheter heart valves due to challenges in anchoring devices in the absence of calcium, concerns of valve embolization, and the high risk of significant residual paravalvular leak.

Methods: The study population consisted of patients treated for severe noncalcific pure AR with transfemoral implantation of a DFM transcatheter heart valve at 6 European centers.

First-in-man transcatheter mitral valve-in-ring implantation with a repositionable and retrievable aortic valve prosthesis.

Aims: Transcatheter interventions with balloon-expandable valves have been shown to be efficacious for the treatment of mitral annuloplasty failure but are limited by the fact that there is no opportunity for post-implantation adjustment. The aim of this study was to assess the safety and efficacy of the fully repositionable and retrievable Direct Flow Medical (DFM) valve for the treatment of mitral annuloplasty failure.

Methods And Results: Patients who underwent transcatheter mitral valve-in-ring (VIR) implantation of a DFM valve for failed mitral annuloplasty deemed high risk for redo surgery were included at four institutions.

Increased Risk of Cerebral Embolization After Implantation of a Balloon-Expandable Aortic Valve Without Prior Balloon Valvuloplasty.

Objectives: The purpose of this study was to analyze the effect of transcatheter aortic valve replacement (TAVR) without versus with prior balloon aortic valvuloplasty (BAV) on the risk of cerebral embolization in patients who receive a balloon-expandable valve.

Background: Avoiding BAV prior to TAVR may simplify the procedure, but the risk of cerebral embolization is currently unknown.

Methods: A total of 87 consecutive high surgical-risk patients with no contraindications for diffusion-weighted magnetic resonance imaging (DW-MRI) were enrolled.

Off-pump versus on-pump coronary-artery bypass grafting in elderly patients.

Background: The benefits of coronary-artery bypass grafting (CABG) without cardiopulmonary bypass in the elderly are still undetermined.

Methods: We randomly assigned patients 75 years of age or older who were scheduled for elective first-time CABG to undergo the procedure either without cardiopulmonary bypass (off-pump CABG) or with it (on-pump CABG). The primary end point was a composite of death, stroke, myocardial infarction, repeat revascularization, or new renal-replacement therapy at 30 days and at 12 months after surgery.

Medtronic Mosaic porcine bioprosthesis: assessment of 12-year performance.

Background: The Mosaic porcine bioprosthesis (Medtronic, Inc, Minneapolis, Minn) was approved in 2000 by the US Food and Drug Administration. Clinical performance was evaluated in 6 centers.

Methods: From 1994 to 2000, 797 patients (mean age 69 years) had aortic valve replacement (AVR) and 232 (mean 67 years) had mitral valve replacement (MVR).

Aortic valve replacement after transapical valve-in-valve implantation.

Transapical valve-in-valve aortic valve replacement has emerged as an attractive alternative for high-risk surgery in elderly patients with degenerated aortic bioprothesis. Despite recent encouraging results, further clinical investigation is required to avoid potential cases of prosthesis-aortic annulus mismatch. We report a surgical valve replacement in a high-risk patient with dysfunctional transapical, implanted aortic valve-in-valve prosthesis 1 year after implantation.

The Mosaic porcine bioprosthesis: role of age on clinical performance in aortic position.

Background: The Mosaic bioprosthesis is a third-generation stented porcine bioprosthesis combining physiologic fixation and α-amino oleic acid antimineralization treatment to improve durability and hemodynamic function. This single-center study reports on the performance of the Mosaic bioprosthesis in patients 65 years of age or less and patients older than 65 years at implantation.

Methods: Between 1994 and 1999, 88 younger patients (mean age, 58 years) and 167 older patients (mean age, 72 years) were enrolled in this prospective nonrandomized clinical trial.

Evaluation of operative risk in elderly patients undergoing aortic valve replacement: the predictive value of operative risk scores.

Objectives: An increasing number of elderly patients develop aortic valve disease requiring surgery. Operative risk scores are currently used to identify patients at high operative risk who may benefit from interventional treatment options. The aim of this study was to analyze the predictive value of these risk scores in geriatric patients undergoing aortic valve replacement.

Factors influencing survival and postoperative quality of life after mitral valve reconstruction.

Objective: Mitral valve reconstruction (MVR) is the preferred treatment for regurgitant lesions. Clinical benefit is well documented, but comparative data scrutinising factors influencing survival and postoperative quality of life (QOL) in different subsets of patients are missing. We hypothesised that mitral valve reconstruction for mitral regurgitation benefits the patients, regardless of the valve pathology.

Clinical results of the Medtronic Mosaic porcine bioprosthesis up to 13 years.

Background: The Mosaic bioprosthesis is a third-generation stented porcine bioprosthesis combining physiologic fixation and alpha-amino oleic acid (AOA) antimineralisation treatment to improve haemodynamic performance and durability. This single-centre study reports the clinical results, including haemodynamic performance, of the Mosaic bioprosthesis after implant in aortic or mitral position.

Methods: Between February 1994 and October 1999, 255 patients with aortic valve replacement (AVR; mean age: 67 years, range: 23-82 years) and 47 patients with mitral valve replacement (MVR; mean age: 67 years, range: 41-84 years) were enrolled in this prospective non-randomised clinical trial.

Desmoteplase in acute massive pulmonary thromboembolism.

Alteplase is standard therapy for patients with acute, massive pulmonary embolism. The novel plasminogen activator desmoteplase displays high fibrin specificity and selectivity for fibrinbound plasminogen. In a preclinical model desmoteplase was twice as potent with a shorter lysis time and lower reocclusion rate.