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The Organ Care System is the only clinical platform for ex-vivo perfusion of human donor hearts. The system preserves the donor heart in a warm beating state during transport from the donor hospital to the recipient hospital. We aimed to assess the clinical outcomes of the Organ Care System compared with standard cold storage of human donor hearts for transplantation. We did this prospective, open-label, multicentre, randomised non-inferiority trial at ten heart-transplant centres in the USA and Europe. Eligible heart-transplant candidates (aged >18 years) were randomly assigned (1:1) to receive donor hearts preserved with either the Organ Care System or standard cold storage. Participants, investigators, and medical staff were not masked to group assignment. The primary endpoint was 30 day patient and graft survival, with a 10% non-inferiority margin. We did analyses in the intention-to-treat, as-treated, and per-protocol populations. This trial is registered with ClinicalTrials.gov, number NCT00855712. Between June 29, 2010, and Sept 16, 2013, we randomly assigned 130 patients to the Organ Care System group (n=67) or the standard cold storage group (n=63). 30 day patient and graft survival rates were 94% (n=63) in the Organ Care System group and 97% (n=61) in the standard cold storage group (difference 2·8%, one-sided 95% upper confidence bound 8·8; p=0·45). Eight (13%) patients in the Organ Care System group and nine (14%) patients in the standard cold storage group had cardiac-related serious adverse events. Heart transplantation using donor hearts adequately preserved with the Organ Care System or with standard cold storage yield similar short-term clinical outcomes. The metabolic assessment capability of the Organ Care System needs further study. TransMedics.

In a randomized trial involving patients with STEMI and cardiogenic shock, mortality at 6 months was lower with mechanical circulatory support with a microaxial flow pump than with standard care alone.

Patients with advanced heart failure were randomly assigned to receive a centrifugal-flow or an axial-flow LVAD. At 2 years, the centrifugal-flow LVAD was associated with less pump replacement and with longer survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.

In this trial, patients with advanced heart failure were assigned to an intrapericardial centrifugal-flow LVAD or an axial-flow LVAD. The intrapericardial device was noninferior to the axial-flow device with respect to survival free from disabling stroke or device malfunction. Advanced heart failure is characterized by profound limitations in survival, functional status, and quality of life despite treatment with evidence-based therapies. 1 Left ventricular assist devices (LVADs) offer patients with this condition a therapeutic option that provides circulatory support while they are awaiting heart transplantation or that can serve as a permanent alternative to transplantation (i.e., “destination therapy”). The Food and Drug Administration (FDA) approved one continuous-flow LVAD with an axial-flow design for destination therapy after outcomes with the device were shown to be superior to those with older, pulsatile LVAD technology. 2 Despite the efficacy of the approved axial-flow LVAD, adverse . . .

Severe tricuspid regurgitation is associated with disabling symptoms and an increased risk of death. Data regarding outcomes after percutaneous transcatheter tricuspid-valve replacement are needed. In this international, multicenter trial, we randomly assigned 400 patients with severe symptomatic tricuspid regurgitation in a 2:1 ratio to undergo either transcatheter tricuspid-valve replacement and medical therapy (valve-replacement group) or medical therapy alone (control group). The hierarchical composite primary outcome was death from any cause, implantation of a right ventricular assist device or heart transplantation, postindex tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the score on the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 m on the 6-minute walk distance. A win ratio was calculated for the primary outcome by comparing all possible patient pairs, starting with the first event in the hierarchy. A total of 267 patients were assigned to the valve-replacement group and 133 to the control group. At 1 year, the win ratio favoring valve replacement was 2.02 (95% confidence interval [CI], 1.56 to 2.62; P<0.001). In comparisons of patient pairs, those in the valve-replacement group had more wins than the control group with respect to death from any cause (14.8% vs. 12.5%), postindex tricuspid-valve intervention (3.2% vs. 0.6%), and improvement in the KCCQ-OS score (23.1% vs. 6.0%), NYHA class (10.2% vs. 0.8%), and 6-minute walk distance (1.1% vs. 0.9%). The valve-replacement group had fewer wins than the control group with respect to the annualized rate of hospitalization for heart failure (9.7% vs. 10.0%). Severe bleeding occurred in 15.4% of the valve-replacement group and in 5.3% of the control group (P = 0.003); new permanent pacemakers were implanted in 17.4% and 2.3%, respectively (P<0.001). For patients with severe tricuspid regurgitation, transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven primarily by improvements in symptoms and quality of life. (Funded by Edwards Lifesciences; TRISCEND II ClinicalTrials.gov number, NCT04482062.).

In a randomized trial, 294 patients with advanced heart failure were assigned to receive either a new centrifugal-flow pump or an axial-flow pump. At 6 months, the centrifugal-flow pump was associated with better outcomes. A scarcity of effective therapeutic options for advanced heart failure has led to the development of durable mechanical circulatory support devices. Left ventricular assist devices, more accurately known as left ventricular assist systems, increase the rate of survival and improve quality of life among patients with advanced heart failure. However, these clinical benefits are balanced by an increased risk of infection, bleeding, neurologic events, and pump malfunction that is due principally to pump thrombosis. 1 , 2 As adoption of circulatory pumps has expanded, concerns about pump thrombosis have heightened. In 2013, two reports suggested that there has been an increase in . . .

In a randomized trial, 366 patients with advanced heart failure received a centrifugal- or axial-flow LVAD. At 2 years, the centrifugal-flow LVAD was superior with regard to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.

Current treatment recommendations for patients with heart failure and secondary mitral regurgitation include transcatheter edge-to-edge repair and mitral-valve surgery. Data from randomized trials comparing these therapies are lacking in this patient population. In this noninferiority trial conducted in Germany, patients with heart failure and secondary mitral regurgitation who continued to have symptoms despite guideline-directed medical therapy were randomly assigned, in a 1:1 ratio, to undergo either transcatheter edge-to-edge repair (intervention group) or surgical mitral-valve repair or replacement (surgery group). The primary efficacy end point was a composite of death, hospitalization for heart failure, mitral-valve reintervention, implantation of an assist device, or stroke within 1 year after the procedure. The primary safety end point was a composite of major adverse events within 30 days after the procedure. A total of 210 patients underwent randomization. The mean (±SD) age of the patients was 70.5±7.9 years, 39.9% were women, and the mean left ventricular ejection fraction was 43.0±11.7%. Within 1 year, at least one of the components of the primary efficacy end point occurred in 16 of the 96 patients with available data (16.7%) in the intervention group and in 20 of the 89 with available data (22.5%) in the surgery group (estimated mean difference, -6 percentage points; 95% confidence interval [CI], -17 to 6; P<0.001 for noninferiority). A primary safety end-point event occurred in 15 of the 101 patients with available data (14.9%) in the intervention group and in 51 of the 93 patients with available data (54.8%) in the surgery group (estimated mean difference, -40 percentage points; 95% CI, -51 to -27; P<0.001). Among patients with heart failure and secondary mitral regurgitation, transcatheter edge-to-edge repair was noninferior to mitral-valve surgery with respect to a composite of death, rehospitalization for heart failure, stroke, reintervention, or implantation of an assist device in the left ventricle at 1 year. (Funded by Abbott Vascular; MATTERHORN ClinicalTrials.gov number, NCT02371512.).

In this trial, 882 cardiac surgical patients with left ventricular dysfunction were assigned to levosimendan or placebo. There was no between-group difference in the rate of death, renal-replacement therapy, perioperative myocardial infarction, or mechanical cardiac assist device use. Cardiac surgery with the use of cardiopulmonary bypass is a common procedure, with more than 1 million operations performed annually in the United States and Europe. 1 Increasingly, patients who are referred for cardiac surgery are older and have multiple coexisting conditions, as compared with those who were referred for these procedures in the past. 2 These patients benefit from cardiac surgery but are at increased risk for perioperative complications that result in high morbidity and mortality and a high use of health care services. 2 – 4 One such complication, the low cardiac output syndrome, occurs in 3 to 14% of patients who . . .

This comparative-effectiveness trial assessed clinical outcomes in patients with advanced heart failure who were not candidates for cardiac transplantation and who had a continuous-flow left ventricular assist device as compared with a pulsatile-flow device. The continuous-flow device resulted in better clinical outcomes, but it has not yet been approved by the Food and Drug Administration. This comparative-effectiveness trial assessed clinical outcomes in patients with advanced heart failure who had a continuous-flow left ventricular assist device as compared with a pulsatile-flow device. The continuous-flow device resulted in better clinical outcomes. Medical and electrical therapies for systolic heart failure have improved outcomes and altered the natural history of the disease. 1 – 9 However, heart failure commonly progresses and becomes refractory to current treatments. Continuous intravenous inotropic support may improve clinical status in the short term but results in a survival rate at 1 year of only 10 to 30%. 10 , 11 Cardiac transplantation is available for only a minority of patients, because of a lack of suitable donor hearts. The paucity of effective therapies for advanced heart failure led to the evaluation of mechanical circulatory-support devices as permanent therapy. To date, only two . . .