Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial.

BACKGROUND: Current guidelines recommend a target international normalized ratio (INR) range of 2.5 to 3.5 in patients with a mechanical mitral prosthesis. The Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) Mitral randomized controlled noninferiority trial assessed safety and efficacy of warfarin at doses lower than currently recommended in patients with an On-X (Artivion, Inc) mechanical mitral valve. METHODS: After On-X mechanical mitral valve replacement, followed by at least 3 months of standard anticoagulation, 401 patients at 44 North American centers were randomized to low-dose warfarin (target INR, 2.0-2.5) or standard-dose warfarin (target INR, 2.5-3.5). All patients were prescribed aspirin, 81 mg daily, and encouraged to use home INR testing. The primary end point was the sum of the linearized rates of thromboembolism, valve thrombosis, and bleeding events. The design was based on an expected 7.3% event rate and 1.5% noninferiority margin. RESULTS: Mean patient follow-up was 4.1 years. Mean INR was 2.47 and 2.92 (P <.001) in the low-dose and standard-dose warfarin groups, respectively. Primary end point rates were 11.9% per patient-year in the low-dose group and 12.0% per patient-year in the standard-dose group (difference, -0.07%; 95% CI, -3.40% to 3.26%). The CI >1.5%, thus noninferiority was not achieved. Rates (percentage per patient-year) of the individual components of the primary end point were 2.3% vs 2.5% for thromboembolism, 0.5% vs 0.5% for valve thrombosis, and 9.13% vs 9.04% for bleeding. CONCLUSIONS: Compared with standard-dose warfarin, low-dose warfarin did not achieve noninferiority for the composite primary end point. (PROACT Clinicaltrials.gov number, NCT00291525).

WITHDRAWN: Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Controlled Trial.

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Innovations in therapies for heart valve disease.

The burden of heart valve disease among adults is enormous in the developed world. Increased life expectancy and age-related valvular degeneration remain the predominant contributors to heart valve dysfunction, which if uncorrected lead to congestive heart failure and increased morbidity and mortality. Clinical evidence on the detrimental impact of valve disease on both pediatric and adult populations has fueled growing interest in diagnosis and therapy for heart valve disease, and also significant financial investment from hospitals and medical device manufacturers in hybrid operating rooms and novel medical device technologies. A wide array of surgical, minimally invasive and percutaneous heart valve technologies are available today, which have significantly enlarged the surgeon's armamentarium, and revolutionized the traditional role of a surgeon in correcting such lesions. Amid this revolution in heart valve technologies, we present recent advances in heart valve therapies, critically appraise their clinical need, and finally discuss the clinical experience and outcomes of some of these technologies. The expected outcome of this review is to provide the clinical reader with a reasonable scientific basis to enable appropriate adoption of these technologies into their clinical practice.

Priorities in coronary artery bypass grafting: Is midterm survival more dependent on completeness of revascularization or multiple arterial grafts?

OBJECTIVE: Both completeness of revascularization and multiple arterial grafts (multiple arterial coronary artery bypass grafting) have been associated with increased midterm survival after coronary artery bypass grafting. The purpose of this study was to evaluate the relative impact of completeness of revascularization and multiple arterial coronary artery bypass grafting on midterm survival after coronary artery bypass grafting. METHODS: A retrospective review of 17,411 isolated, primary coronary artery bypass grafting operations from January 2002 to June 2016 at a US academic institution was performed. Patients were divided into groups based on complete or incomplete revascularization and number of arterial grafts. Inverse probability of treatment weighting based on the generalized propensity score was performed to minimize imbalance in preoperative characteristics. Between-group differences in outcomes were assessed using multivariable logistic and Cox regression analyses, incorporating the propensity score weights. RESULTS: Patients undergoing multiple arterial coronary artery bypass grafting in this study were younger, had fewer comorbid conditions, and had lower incidence of left main stenosis compared with patients undergoing single-arterial coronary artery bypass grafting. Short-term perioperative outcomes were similar between groups once propensity score weighting was used to minimize between-group differences in preoperative variables. Median follow-up in the entire population was 630 days, but was 1366 days in the cohort with data available from the Social Security Death Index. Multiple arterial coronary artery bypass grafting was protective for midterm survival compared with single arterial coronary artery bypass grafting, regardless of complete or incomplete revascularization or strategy (multiple arterial complete revascularization vs single-arterial complete revascularization: hazard ratio, 0.82; 95% confidence interval, 0.69-0.97; P = .02; multiple arterial incomplete revascularization vs single-arterial incomplete revascularization: hazard ratio, 0.70; 95% confidence interval, 0.53-0.90; P = .007). CONCLUSIONS: After controlling for preoperative comorbidities, multiple arterial coronary artery bypass grafting provides a modest midterm survival benefit over single-arterial coronary artery bypass grafting irrespective of completeness of revascularization, suggesting that when forced to choose, surgeons may elect to pursue multiple arterial conduits.

Total aortic arch replacement for the treatment of Kommerell's diverticulum in a Jehovah's Witness.

The treatment of Kommerell's diverticulum continues to evolve given advances in aortic surgery, cardiopulmonary bypass management, and endovascular techniques. This case report details the repair of a diverticulum of Kommerell in a Jehovah's witness with a right-sided aortic arch and reviews the surgical literature.

Midterm benefits of surgical pulmonary embolectomy for acute pulmonary embolus on right ventricular function.

OBJECTIVE: Surgical pulmonary embolectomy has been used for the successful treatment of massive and submassive pulmonary emboli. The purpose of this study is to document the short- and midterm echocardiographic follow-up of right ventricular function after surgical pulmonary embolectomy for acute pulmonary embolus. METHODS: A retrospective review of the local Society of Thoracic Surgeons database of patients who underwent surgical pulmonary embolectomy for acute pulmonary embolectomy was conducted from 1998 to 2014 at a US academic center. Patients with chronic thrombus were excluded. The institutional echocardiographic database was searched for follow-up studies to compare markers of right ventricular function. Unadjusted outcomes were described, and quantitative comparisons were made of short- and long-term echocardiographic data. RESULTS: A total of 44 patients were included for analysis; 35 patients (79.5%) had a submassive pulmonary embolectomy, and 9 patients (20.5%) had a massive pulmonary embolectomy and required preoperative inotropy. Mean cardiopulmonary bypass time was 68.0 ± 40.2 minutes, and 30 patients (68.2%) underwent procedures without aortic crossclamping. There was 1 in-hospital mortality (2.3%), and there were no permanent neurologic deficits. A total of 21 patients had echocardiography results available for follow-up. Perioperative echocardiographic data showed an immediate decrease in tricuspid regurgitant velocity and right ventricular pressure (P < .05). Mean midterm echocardiographic follow-up was 30 months in 12 patients. At midterm follow-up, improvements in right ventricular function observed postoperatively persisted. Only 1 patient had moderate right ventricular dysfunction, and no patient had worse than mild tricuspid regurgitation. Mean tricuspid valve regurgitant velocity was 2.4 ± 0.7 m/s, and mean pulmonary artery systolic pressure was 37.2 ± 14.2 mm Hg. CONCLUSIONS: Surgical pulmonary embolectomy may represent optimal therapy in selected patients for massive and submassive acute pulmonary emboli given the low morbidity and mortality rates. Echocardiographic follow-up shows preserved improvement in right ventricular function in the majority of patients.

Injury to the conduction system: management of life-threatening arrhythmias after penetrating cardiac trauma.

BACKGROUND: Life-threatening conduction abnormalities after penetrating cardiac injuries (PCIs) are rare, and rapid identification and treatment of these arrhythmias are critical to survival. This study highlights diagnosis and management strategies for conduction abnormalities after PCI. METHODS: Patients with life-threatening arrhythmias after PCI were identified at an urban, level I trauma center registry. RESULTS: Seventy-one patients survived to reach the hospital after PCI. Of these, 3 (4%) survivors (male = 3, mean age 41.3, median injury severity score = 25) had critical conduction abnormalities after cardiorrhaphy. All patients had multichamber and atrioventricular nodal injury. After initial cardiorrhaphy and control of hemorrhage, all patients had sustained hypotension with bradycardia from complete heart block. Two patients had ventricular septal defects requiring repair. All 3 patients survived. CONCLUSIONS: Rapid recognition of injury to the cardiac conduction system after PCI as a source of sustained hypotension is essential to early restoration of cardiac function and survival.