Congenital heart disease (CHD) accounts for nearly one-third of all major congenital anomalies. CHD birth prevalence worldwide and over time is suggested to vary; however, a complete overview is missing. This systematic review included 114 papers, comprising a total study population of 24,091,867 live births with CHD identified in 164,396 individuals. Birth prevalence of total CHD and the 8 most common subtypes were pooled in 5-year time periods since 1930 and in continent and income groups since 1970 using the inverse variance method. Reported total CHD birth prevalence increased substantially over time, from 0.6 per 1,000 live births (95% confidence interval [CI]: 0.4 to 0.8) in 1930 to 1934 to 9.1 per 1,000 live births (95% CI: 9.0 to 9.2) after 1995. Over the last 15 years, stabilization occurred, corresponding to 1.35 million newborns with CHD every year. Significant geographical differences were found. Asia reported the highest CHD birth prevalence, with 9.3 per 1,000 live births (95% CI: 8.9 to 9.7), with relatively more pulmonary outflow obstructions and fewer left ventricular outflow tract obstructions. Reported total CHD birth prevalence in Europe was significantly higher than in North America (8.2 per 1,000 live births [95% CI: 8.1 to 8.3] vs. 6.9 per 1,000 live births [95% CI: 6.7 to 7.1]; p < 0.001). Access to health care is still limited in many parts of the world, as are diagnostic facilities, probably accounting for differences in reported birth prevalence between high- and low-income countries. Observed differences may also be of genetic, environmental, socioeconomical, or ethnic origin, and there needs to be further investigation to tailor the management of this global health problem.

No abstract

ObjectivesTo propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publication, on behalf of the public health.BackgroundTranscatheter aortic valve implantation may provide a worthwhile less invasive treatment in many patients with severe aortic stenosis and since its introduction to the medical community in 2002, there has been an explosive growth in procedures. The integration of TAVI into daily clinical practice should be guided by academic activities, which requires a harmonized and structured process for data collection, interpretation, and reporting during well-conducted clinical trials.Methods and resultsThe Valve Academic Research Consortium established an independent collaboration between Academic Research organizations and specialty societies (cardiology and cardiac surgery) in the USA and Europe. Two meetings, in San Francisco, California (September 2009) and in Amsterdam, the Netherlands (December 2009), including key physician experts, and representatives from the US Food and Drug Administration (FDA) and device manufacturers, were focused on creating consistent endpoint definitions and consensus recommendations for implementation in TAVI clinical research programs. Important considerations in developing endpoint definitions included (i) respect for the historical legacy of surgical valve guidelines; (ii) identification of pathophysiological mechanisms associated with clinical events; (iii) emphasis on clinical relevance. Consensus criteria were developed for the following endpoints: mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, and prosthetic valve performance. Composite endpoints for TAVI safety and effectiveness were also recommended.ConclusionAlthough consensus criteria will invariably include certain arbitrary features, an organized multidisciplinary process to develop specific definitions for TAVI clinical research should provide consistency across studies that can facilitate the evaluation of this new important catheter-based therapy. The broadly based consensus endpoint definitions described in this document may be useful for regulatory and clinical trial purposes.

ince the initial publication of ''Guidelines for Reporting Morbidity and Mortality After Cardiac Valvular Operations'' in 1988, 1 followed by a revised version in 1996, 2 valvular heart surgery has evolved to include an enhanced understanding of patient-and disease-related factors affecting outcomes, increased numbers of valve repairs, more operations performed for patients with minimal symptoms, new prostheses, novel repair methods, and the emergence of percutaneous interventional (catheter-based) valve repair and replacement. To adapt to this changing environment, the Councils of the American Association for Thoracic Surgery, The Society of Thoracic Surgeons, and The European Association for Cardio-Thoracic Surgery have directed an Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity to review current clinical practice to update and clarify these reporting guidelines. The guidelines are intended to cover treatment of all four cardiac valves in both adult and pediatric patients. Further, these guidelines apply uniformly, irrespective of whether the therapy was carried out as a conventional open operation, as a minimally invasive (video-assisted or robotic) surgical procedure, or with percutaneous interventional catheter techniques. PurposeThese reporting guidelines are intended to facilitate analysis and reporting of clinical results of various therapeutic approaches to diseased heart valves such that meaningful comparisons can be made and inferences drawn from investigations of medical, surgical, and percutaneous interventional treatment of patients with valvular heart disease. Early MortalityEarly mortality is to be reported as all-cause mortality at 30, 60, or 90 days and depicted by actuarial estimates (with number remaining at risk and confidence intervals [CIs]) or as simple percentages, regardless of the patient's location, be it home or in a health care facility.

Prosthesis-patient mismatch is associated with an increase in all-cause and cardiac-related mortality over long-term follow-up. We recommend that current efforts to prevent PPM should receive more emphasis and a widespread acceptance to improve long-term survival after AVR.