Medical malpractice in aortic valve and mitral valve replacement surgery in North America.

BACKGROUND: Aortic and mitral valve replacement are commonly performed by cardiovascular surgeons, but little data quantitatively analyzes the etiology and prevalence of medical malpractice litigations involving these operations. This study aims to analyze incidence, cause, and resolution of medical malpractice lawsuits involving aortic and mitral valve replacements, alone and in combination with coronary artery bypass and/or aortic procedures. METHODS: The Westlaw legal database was utilized to compile relevant litigations across the United States from 1994-2019. Clinical data, verdict data, demographic data, and litigation attributes were compiled. Fisher's Exact Tests and Mann-Whitney tests were performed for statistical analyses. One hundred four malpractice litigations involving aortic valve replacement and 55 litigations involving mitral valve replacement were included in this analysis. The mean age of patients was 55.2 years and proportion of female patients was 32.7% in aortic valve replacements litigations, compared to a mean age of 54.1 years and female patients in 61.8% of mitral valve replacements litigations. RESULTS: Significant relationships exist between an alleged failure to monitor the patient and defendant verdicts (P=0.01), delayed treatment and defendant verdicts (P=0.04), and incidence of infective endocarditis and plaintiff verdicts (P=0.04) in aortic valve replacement litigations. Similarly, significant relationships exist between an alleged failure to diagnose and settlement verdicts (P=0.047), and stroke incidence and defendant verdicts (P=0.03) in mitral valve replacement litigations. CONCLUSIONS: In addition to excellent surgeon patient/family communication, administering surgical treatment in a timely manner, diagnosing acting on concomitant medical conditions, and close patient monitoring may diminish medical malpractice litigation involving aortic and mitral valve replacement operations.

Regulatory approval review of transcatheter mitral valve repair - Difference in the indication between the USA and Japan.

The indication for MitraClip (Abbott Vascular, Santa Clara, CA, USA) in the USA is degenerative mitral regurgitation (DMR), but the Japanese indication includes both DMR and functional mitral regurgitation (FMR), in patients without severe left ventricular dysfunction. One of the reasons for this difference is that the Japanese Circulation Society submitted a formal request to the Japanese government for early approval of MitraClip for both DMR and FMR on the basis of unmet medical need for MR patients resistant to medical therapy, but at prohibitive risk for mitral valve surgery. Here, we describe the regulatory approval review process of MitraClip in Japan. Clinical data from outside Japan indicated that MitraClip provides significant improvements from baseline in New York Heart Association Class and hospitalizations for heart failure due to the reduction of MR grade without adversely affecting long-term prognosis in FMR patients as well as DMR patients. Also, a Japanese domestic trial showed a favorable acute procedural success rate without serious adverse events with MitraClip in both DMR and FMR patients. Further, it is considered in Japan that improvement of MR mechanically is clinically important in both DMR and FMR, in patients without severe left ventricular dysfunction. On the basis of these considerations, the MitraClip was approved in Japan for indications of both DMR and FMR with preserved cardiac function in patients at prohibitive risk for mitral valve surgery.

Evaluation of the Melody transcatheter pulmonary valve and Ensemble delivery system for the treatment of dysfunctional right ventricle to pulmonary artery conduits.

Synthetic conduits and bioprosthetic valves are used in the treatment of patients with congenital heart disease involving the right ventricular outflow tract and pulmonary valve. In-situ time-dependent degradation uniformly results in conduit and valve dysfunction. The abnormal hemodynamics imposed by valve and conduit dysfunction have been linked to exercise intolerance, arrhythmia, right heart failure, and sudden death. Starting in childhood, affected patients are subjected to repeated open-heart surgeries to restore valve function and potentially reduce morbidity and mortality. Percutaneous transcatheter pulmonary valve replacement with the Melody Transcatheter Pulmonary Valve (Medtronic, Inc., Minneapolis, MN) has been performed in ≈8000 patients worldwide. The valve and implant procedure provide a far less invasive means of restoring valve and conduit function and allow patients to forego multiple operations. Recent clinical trials have shown excellent and durable results in terms of valve function, relief of obstruction, and improvement in functional class up to 7 years from implant.