Head, S.J.

The SYNTAX score and its clinical implications (Article)

2013-03-28T00:00:00Z

Analysis of Stroke Occurring in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) Trial Comparing Coronary Artery Bypass Surgery and Percutaneous Coronary Intervention in the Treatment of Complex Coronary Artery Disease (Article)

2013-03-21T00:00:00Z

Objectives: This study sought to analyze stroke rates in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial's randomized and registry cohorts of patients being treated with coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) for treatment of complex coronary artery disease. Background: The SYNTAX trial compared PCI to CABG in patients with de novo 3-vessel and/or left main coronary disease. Methods: The SYNTAX randomized trial was conducted at 85 U.S. and European sites (n = 1,800). All strokes (up to 4 years) were independently adjudicated by a clinical events committee that included a neurologist. An additional 1,077 (of which 644 were followed for 5 years) and 198 patients were included in the CABG and PCI registries, respectively. Results: In the randomized cohort, 31 CABG and 19 PCI patients experienced 33 and 20 strokes post-randomization at 4-year follow-up, respectively (p = 0.062). Three strokes occurred pre-procedurally but following randomization in CABG-treated patients. After CABG, a large proportion of strokes occurred acutely (0 to 30 days: 9 of 33), whereas in the PCI arm, most strokes occurred >30 days after the procedure (18 of 20). Stroke resulted in death in 3 patients in both the PCI and CABG groups. Of the patients who developed stroke, 68% (21 of 31) in the CABG group had residual deficits at discharge; in the PCI group, 47% (9 of 19) had residual deficits. In a multivariate analysis, treatment with CABG was not significantly associated with increased stroke rates (odds ratio: 1.67, 95% confidence interval: 0.93 to 3.01, p = 0.089). The incidence and outcomes of stroke were similar in the randomized trial and registries. Conclusions: There is a higher risk of periprocedural stroke in patients undergoing CABG versus PCI; however, the risk converges over the first 4 years of follow-up. (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery [SYNTAX]; NCT00114972).

Appropriate Coronary Artery Bypass Grafting Use in the Percutaneous Coronary Intervention Era: Are We Finally Making Progress? (Article)

2012-12-01T00:00:00Z

Appropriate use criteria integrate guidelines, clinical trial evidence, and expert opinion in order to determine the most appropriate care for a range of distinct clinical scenarios. Inappropriate use estimates cannot be neglected. Approximately 12%-14% of all percutaneous coronary interventions and 1%-2% of all coronary artery bypass grafting procedures in patients with stable angina are deemed inappropriate. Several reasons for this difference are identified. Continuous improvement of the criteria, multidisciplinary discussions, and the correct financial incentives will be essential in reducing the number of inappropriate procedures, improve patient outcomes, and contain costs.

Updated standardized endpoint definitions for transcatheter aortic valve implantation: The valve academic research consortium-2 consensus document (varc-2) (Article)

2012-11-01T00:00:00Z

Objectives: The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. BACKGROUND: A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. METHODS AND Results: Two in-person meetings (held in September 2011 in Washington, DC, USA, and in February 2012 in Rotterdam, Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and non-interventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiographic recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for several recommended composite endpoints. Conclusions: This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of the study results, supplying an increasingly growing body of evidence with respect to TAVI and/or surgical aortic valve replacement. This initiative and document can furthermore be used as a model during current endeavours of applying definitions to other transcatheter valve therapies (for example, mitral valve repair). Published on behalf of the European Association for Cardio-Thoracic Surgery. The article has been co-published in the European Heart Journal, EuroIntervention, Journal of the American College of Cardiology, and Journal of Thoracic and Cardiovascular Surgery. All rights reserved. © The Author 2012.

Preoperative beta-blocker usage: Is it really worthy of being a quality indicator? (Article)

2011-09-01T00:00:00Z

Background: Since 2007, the use of preoperative β-blockers has been used as a quality standard for patients undergoing coronary artery bypass graft surgery. Recent studies have called into question of the benefit of empiric preoperative β-blocker use. Methods: Data were extracted from our Society of Thoracic Surgeons certified database for patients undergoing isolated coronary artery bypass graft surgery from 2000 to 2008. We compared the outcomes for patients who received preoperative β-blockers with those of patients who did not. Results: The study group had 12,855 patients, of whom 7,967 (62.0%) were treated preoperatively with β-blockers. Using propensity matching, we selected two matched groups of 4,474 patients with preoperative β-blocker use and 4,474 not using preoperative β-blockers. In the unmatched cohort, only deep sternal infection (0.3% versus 0.5% without β-blockers; p = 0.032), pneumonia (1.9% versus 2.4% without β-blockers; p = 0.039), and intraoperative blood usage (37.2% versus 34.1% without β-blockers; p < 0.001) reached statistically significant difference. In the matched groups, there was no difference between adverse event rates in patients treated with β-blockers and those who were not. The number of patients requiring intraoperative blood product use was significantly higher among β-blockertreated patients (p = 0.004). Calculating the adjusted odds ratios showed that in the matched groups, the preoperative use of β-blockers was not an independent predictor of mortality. Conclusions: A rational for preoperative β-blockade exists. However, as with any medical intervention, its application should be tailored to specific clinical scenarios. With no differences in mortality or morbidity, our findings do not support preoperative β-blockade as a useful quality indicator for coronary artery bypass graft surgery.

Nonrandomized data on drug-eluting stents compared with coronary bypass surgery: Caution with interpretation (Article)

2011-06-14T00:00:00Z

Details in a meta-analysis comparing mitral valve repair to replacement for ischemic regurgitation (Article)

2011-06-02T00:00:00Z

A crucial factor in shared decision making: The team approach (Article)

2011-05-28T00:00:00Z

Fungal endocarditis after transfemoral aortic valve implantation (Article)

2011-05-09T00:00:00Z

Transcatheter aortic valve implantation (TAVI) was introduced in 2006 as an alternative for surgical aortic valve replacement (SAVR) as treatment for patients with aortic stenosis. Endocarditis after TAVI has been anecdotally reported, but concerns aroused because SAVR is often needed to explant the endocarditic valve in a high risk patient previously deemed not to be a surgical candidate. We report a case of a patient who underwent TAVI because he was too high risk to undergo SAVR. Several months later, he developed an intermittent self-limiting fever of unknown origin which eventually was diagnosed as endocarditis. The valve was surgically removed, and pathology showed an infection caused by Histoplasma capsulatum. The patient recovered fully and remains in good condition.

Survival of surgically treated infective endocarditis: A comparison with the general dutch population (Article)

2011-05-01T00:00:00Z

Background: Infective endocarditis (IE) remains associated with high in-hospital and long-term mortality. The outcome of patients with IE who are operated on has never been put into perspective by comparing it to the age-matched and gender-matched general population. The aim of the present study was to evaluate the long-term mortality of patients with IE who undergo operation in relation to the age-matched and gender-matched general population. Methods: A retrospective observational cohort study of 138 patients with IE who underwent consecutive operations (19982007) was conducted. Cumulative survival was analyzed using the Kaplan-Meier method. Comparison of patient survival with the general population was done using the Dutch population life table. The standardized mortality ratio was used to assess the degree of late deaths. Results: The observed in-hospital mortality risk was 10.9%. The observed long-term survival was 85% (95% confidence interval, 78% to 90%), 74% (95% confidence interval, 65% to 79%), 71% (95% confidence interval, 62% to 78%) after 1, 5, and 10 years, respectively. Age-matched and gender-matched survival in the general population was 99%, 93%, and 80% after a follow-up period of 1, 5, and 10 years, respectively. The standardized mortality ratio was 0.99 (95% confidence interval, 0.67 to 1.31). Conclusions: Although mortality of IE patients who have undergone operation remains considerable during the immediate postoperative period, the mortality of hospital survivors is, with increasing follow-up time, comparable with the general population.

43.3-year durability of a Smeloff-Cutter ball-caged mitral Valve (Article)

2011-02-01T00:00:00Z

Extended durability of mechanical heart valves has been documented for many years. We describe a case of a ball-caged mechanical valve implanted 43.3 years previous to developing valve dysfunction. The patient presented with both prosthetic valve stenosis and insufficiency. This Smeloff-Cutter valve (Cutter Laboratories, Berkeley, CA) in the mitral position was dysfunctional due to lipid absorption, which resulted in ball variance and concomitant pannus growth prevented optimal seating of the ball in its cage. This is the longest length of time in which a Smeloff-Cutter mechanical valve has been originally implanted.

Long term follow up after surgery in congenitally corrected transposition of the great arteries with a right ventricle in the systemic circulation (Article)

2010-09-28T00:00:00Z

Aim of the study: To investigate the long-term outcome of surgical treatment for congenitally corrected transposition of the great arteries (CCTGA), in patients with biventricular repair with the right ventricle as systemic ventricle.Methods: A total of 32 patients with CCTGA were operated between January 1972 and October 2008. These operations comprised 18 patients with a repair with a normal left ventricular outflow tract, 11 patients with a Rastelli repair of the left ventricle to the pulmonary artery and 3 patients with a cardiac transplantation.Results: Excluding the cardiac transplantation patients, mean age at operation was 16 years (sd 15 years, range 1 week - 49 years). Median follow-up was 12 years (sd 10 years, range 7 days - 32 years). Survival obtained from Kaplan-Meier analysis at 20 years after surgery was 63% (CI 53-73%). For the non-Rastelli group these data at 20 years were 62% (CI 48-76%) and for the Rastelli group 67% (CI 51-83%). Freedom of reoperation at 20 years was 32% (CI 19-45%) in the overall group. In the non-Rastelli group the data at 20 years were 47% (CI 11-83%) and for the Rastelli group 21% (CI 0-54%) after almost 19 years.Conclusions: Long term follow up confirms that surgery in CCTGA with the right ventricle as systemic ventricle has a suboptimal survival and limited freedom of reoperation. Death occurred mostly as a result of cardiac failure.