Migration despite stabilization of an embolized transcatheter heart valve: A word of caution.

This case report describes an initially stabilized transcatheter heart valve that embolized in the ascending aorta, leading to a postprocedural acute type A aortic dissection.

No surgical innovation without evaluation: the IDEAL recommendations.

Surgery and other invasive therapies are complex interventions, the assessment of which is challenged by factors that depend on operator, team, and setting, such as learning curves, quality variations, and perception of equipoise. We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process. We also encourage the widespread use of prospective databases and registries. Reports of new techniques should be registered as a professional duty, anonymously if necessary when outcomes are adverse. Case series studies should be replaced by prospective development studies for early technical modifications and by prospective research databases for later pre-trial evaluation. Protocols for these studies should be registered publicly. Statistical process control techniques can be useful in both early and late assessment. Randomised trials should be used whenever possible to investigate efficacy, but adequate pre-trial data are essential to allow power calculations, clarify the definition and indications of the intervention, and develop quality measures. Difficulties in doing randomised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems. Alternative prospective designs, such as interrupted time series studies, should be used when randomised trials are not feasible. Established procedures should be monitored with prospective databases to analyse outcome variations and to identify late and rare events. Achievement of improved design, conduct, and reporting of surgical research will need concerted action by editors, funders of health care and research, regulatory bodies, and professional societies.

Evaluation and stages of surgical innovations.

Surgical innovation is an important part of surgical practice. Its assessment is complex because of idiosyncrasies related to surgical practice, but necessary so that introduction and adoption of surgical innovations can derive from evidence-based principles rather than trial and error. A regulatory framework is also desirable to protect patients against the potential harms of any novel procedure. In this first of three Series papers on surgical innovation and evaluation, we propose a five-stage paradigm to describe the development of innovative surgical procedures.

Challenges in evaluating surgical innovation.

Research on surgical interventions is associated with several methodological and practical challenges of which few, if any, apply only to surgery. However, surgical evaluation is especially demanding because many of these challenges coincide. In this report, the second of three on surgical innovation and evaluation, we discuss obstacles related to the study design of randomised controlled trials and non-randomised studies assessing surgical interventions. We also describe the issues related to the nature of surgical procedures-for example, their complexity, surgeon-related factors, and the range of outcomes. Although difficult, surgical evaluation is achievable and necessary. Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential.

Sutureless patch technique for postinfarction left ventricular rupture.

BACKGROUND: Left ventricular free wall rupture is an uncommon but catastrophic event after myocardial infarction and is associated with a high mortality. After prompt diagnosis some patients may be salvaged with immediate surgical intervention. Surgical techniques used to seal the rupture vary, as few surgeons have experience with this pathologic process. We report our experience using a sutureless patch technique to treat this entity. METHODS: A review of 6 consecutive patients during an 8-year period who were referred to one cardiac unit with postinfarction left ventricular rupture was conducted. RESULTS: There were 3 men and 3 women with an average age of 71.8 years. All were hemodynamically unstable, and 4 were in electromechanical dissociation. Echocardiography confirmed the diagnosis in 5 patients, and cardiac catheterization had been performed in 4 before rupture. All patients were treated promptly with fluid, inotropic agents, and, if needed, cardiopulmonary resuscitation and pericardiocentesis. Resuscitation was continued in the operating room, and the myocardial tear was sealed with a generous patch of unsupported felt secured to the heart with cyanoacrylate glue. Coronary artery bypass grafting was performed in 3 patients if the anatomy was known. All patients survived to the intensive care unit. One death occurred as a result of severe neurologic injury. Five patients were discharged from the hospital, and all were alive 2 months to 7.5 years after operation. CONCLUSIONS: A sutureless patch technique for the treatment of postinfarction rupture is simple, effective, and associated with a favorable outcome.

Use of methylene blue for catecholamine-refractory vasoplegia from protamine and aprotinin.

We present two cases of catecholamine-refractory and vasopressin-refractory vasoplegic syndrome associated with intraoperative anaphylaxis during cardiac surgery. One case was related to the administration of protamine and the other case to the administration of aprotinin. Both cases were successfully managed using intravenous methylene blue. The use of methylene blue blocks accumulation of cyclic guanosine monophosphate by competitively inhibiting the enzyme guanylate cyclase. This results in reduced responsiveness of the vasculature to cyclic guanosine monophosphate-mediated vasodilators, such as nitric oxide. This report provides a description of severe anaphylaxis induced by different agents, in which the use of methylene blue was associated with a significant clinical response.