Impact of Accurate 30-Day Status on Operative Mortality: Wanted Dead or Alive, Not Unknown.

Background: Risk-adjusted operative mortality is the most important quality metric in cardiac surgery for determining The Society of Thoracic Surgeons (STS) Composite Score for star ratings. Accurate 30-day status is required to determine STS operative mortality. The goal of this study was to determine the effect of unknown or missing 30-day status on risk-adjusted operative mortality in a regional STS Adult Cardiac Surgery Database cooperative and demonstrate the ability to correct these deficiencies by matching with an administrative database.

Transcatheter Versus Surgical Aortic Valve Replacement: Propensity-Matched Comparison.

Background: Randomized trials support the use of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis in high- and intermediate-risk patients, but the generalizability of those results in clinical practice has been challenged.

Objectives: The aim of this study was to determine the safety and effectiveness of TAVR versus surgical aortic valve replacement (SAVR), particularly in intermediate- and high-risk patients, in a nationally representative real-world cohort.

Methods: Using data from the Transcatheter Valve Therapy Registry and Society of Thoracic Surgeons National Database linked to Medicare administrative claims for follow-up, 9,464 propensity-matched intermediate- and high-risk (Society of Thoracic Surgeons Predicted Risk of Mortality score ≥3%) U.

Underestimation of the incidence of new-onset post-coronary artery bypass grafting atrial fibrillation and its impact on 30-day mortality.

Objective: Inconsistent definitions of atrial fibrillation after coronary artery bypass grafting have caused uncertainty about its incidence and risk. We examined the extent to which limiting the definition to post-coronary artery bypass grafting atrial fibrillation events requiring treatment underestimates its incidence and impact on 30-day mortality.

Methods: We assessed in-hospital atrial fibrillation and 30-day mortality in 9268 consecutive patients without preoperative atrial fibrillation who underwent isolated coronary artery bypass grafting at 5 US hospitals (2004-2010).

How to Start a Biomedical Device Company: Physicians Can Lead the Team Effort.

Taking a solution for a clinical unmet need from a mere idea to a profitable medical device company is a long and complex process. After developing a prototype solution, the physician-inventor must quickly file a patent to protect his or her intellectual property. After the patent is secured, the first major business decision arrives: should the inventor sell the patent or maintain ownership? If the inventor decides to maintain ownership, he or she will face a series of hurdles from obtaining additional funding to device development, and ultimately, commercialization and marketing of the product.

The Central Role of Endothelial Dysfunction in Cardiorenal Syndrome.

Background: Endothelial dysfunction (ED) has emerged as a critical process in cardiorenal syndrome (CRS). The concept that ED is closely linked with cardiac and renal dysfunction has become an important target for CRS-related research and clinical practice.

Summary: The sequence of events leading to ED is initiated by type I endothelial activation (almost immediately) and type II endothelial activation (over hours, days, and even months), followed by endothelial apoptosis and endothelial necrosis.

Transcatheter Aortic Valve Replacement and MitraClip to Reverse Heart Failure.

Valvular heart diseases such as aortic stenosis and mitral regurgitation are often associated with heart failure, which in turn increases patients' Surgical Thoracic Society (STS) score. A high STS score means the patient is high risk for surgical aortic valve replacement and mitral valve repair/replacement. Transcatheter aortic valve replacement and percutaneous mitral valve repair offer a minimally invasive alternative for the treatment of valvular heart disease in patients with severe heart failure.

Application of Clinical Intelligence to Streamline Care in Aortic Emergencies.

This article discusses the lessons learned by an interdisciplinary team in a large metropolitan specialty hospital during the implementation of the Code Aorta protocol for aortic emergencies and the subsequent application of technological enhancements to improve data transfer. Aortic dissections require rapid diagnosis and surgical treatment; thus, in order to optimize patient outcomes, clinicians must be accessible, data must be readily available, and proper prompts and notifications must be made to alert and ready teams. An interdisciplinary team reviewed our hospital's processes and architecture of systems to define how we provide care during aortic emergencies.

Influence of practice patterns on outcome among countries enrolled in the SYNTAX trial: 5-year results between percutaneous coronary intervention and coronary artery bypass grafting.

Objectives: To examine differences among participating countries in baseline characteristics, clinical practice, medication strategies and outcomes of patients randomized to coronary artery bypass grafting and percutaneous coronary intervention in the SYNTAX trial.

Methods: In SYNTAX, centres in 18 different countries enrolled 1800 patients, of which 8 countries enrolled ≥80 patients, what was projected to be a large enough sample size to be included in the analysis. Baseline characteristics, practice patterns and clinical outcomes were compared between the USA (n = 245), the UK (n = 267), Italy (n = 197), France (n = 208), Germany (n = 179), Netherlands (n = 148), Belgium (n = 91) and Hungary (n = 83).

David-V Procedure in a Patient with Aortic Dilation and Competent Quadricuspid Aortic Valve: Are Genetics to Blame?

Quadricuspid aortic valves (QAVs) are extremely rare. In this case study, we report a David-V valve-sparing aortic root replacement with reimplantation of a native QAV in a patient with aortic dilation, normal valve function, and a family history of aortic dissection. Microscopic pathological examination of the excised section of the aorta revealed scattered small foci of cystic medical degeneration throughout.

Categorizing body mass index biases assessment of the association with post-coronary artery bypass graft mortality.

Objectives: The high prevalence of obesity makes accurately estimating the impact of anthropometric measures on cardiac surgery outcomes critical. The Society of Thoracic Surgeons coronary artery bypass graft (CABG) surgery risk model includes body surface area (as a continuous variable, using spline functions), but most studies apply various categorizations of body mass index (BMI)-contributing to the contradictory published findings. We assessed the association between BMI (modelled as a continuous variable without assumptions of linearity) and CABG operative mortality and examined the impact of applying previous studies' BMI modelling strategies.

Personalized treatment of heart failure with biomarker guidance using a novel disease severity score.

We propose a novel Myocardial Injury Summary Score (MISS) integrating the 4 biomarkers suggested by the 2013 American College of Cardiology/American Heart Association guidelines for management of heart failure. In this case series, we examined 4 heart failure patients who received treatment guided by the biomarker results and 4 patients who received routine clinical management with no information about the biomarkers. Most of the patients receiving biomarker-guided management had medications adjusted based on the biomarker values, while no changes were recommended for patients in the biomarker-blinded category.

Pneumonia after cardiac surgery: Experience of the National Institutes of Health/Canadian Institutes of Health Research Cardiothoracic Surgical Trials Network.

Rationale: Pneumonia remains the most common major infection after cardiac surgery despite numerous preventive measures.

Objectives: To prospectively examine the timing, pathogens, and risk factors, including modifiable management practices, for postoperative pneumonia and estimate its impact on clinical outcomes.

Methods: A total of 5158 adult cardiac surgery patients were enrolled prospectively in a cohort study across 10 centers.

Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery.

Background: Levosimendan is an inotropic agent that has been shown in small studies to prevent or treat the low cardiac output syndrome after cardiac surgery.

Methods: In a multicenter, randomized, placebo-controlled, phase 3 trial, we evaluated the efficacy and safety of levosimendan in patients with a left ventricular ejection fraction of 35% or less who were undergoing cardiac surgery with the use of cardiopulmonary bypass. Patients were randomly assigned to receive either intravenous levosimendan (at a dose of 0.

Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect.

Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect.