Faculty Bibliography

Heart Failure is a global epidemic, affecting approximately 5 million adults in the U.S.A. The cornerstone of contemporary pharmacological therapy targets the over activated renin-angiotensin-aldosterone and sympathetic autonomic systems. The 2016 focused pharmacologic update on the current Heart Failure Guidelines introduces the use of two newly approved regimens valsartan/sacubitril and ivabradine. Over the last two decades, guideline directed medical therapy has accomplished significant improvement in survival rates among heart failure patients; however these novel compounds were reported to exert additional mortality and morbidity benefits, in heart failure subpopulations with reduced ejection fraction.

Cancer and cardiovascular disease account for nearly half of all deaths in the US. The majority of cancer therapies are known to cause potential cardiac toxicity in some form. Patients with underlying cardiac disease are at a particularly increased risk for worse outcomes following cancer therapy. Most alarming is the potential for heart failure as a result of cancer treatment, which may lead to early disruption or withdrawal of life-saving cancer therapies and can potentially increase cardiovascular mortality. A multi-disciplinary cardio-oncology approach can improve outcomes through early surveillance, prevention and treatment strategies.

The increasing burden and the continued suboptimal outcomes for patients with heart failure underlines the importance of continued research to develop novel therapeutics for this disorder. This can only be accomplished with successful translation of basic science discoveries into direct human application through effective clinical trial design and execution that results in a substantially improved clinical course and outcomes. In this respect, phase II clinical trials play a pivotal role in determining which of the multitude of potential basic science discoveries should move to the large and expansive registration trials in humans. A critical examination of the phase II trials in heart failure reveals multiple shortcomings in their concept, design, execution, and interpretation. To further a dialogue on the challenges and potential for improvement and the role of phase II trials in patients with heart failure, the Food and Drug Administration facilitated a meeting on October 17, 2016, represented by clinicians, researchers, industry members, and regulators. This document summarizes the discussion from this meeting and provides key recommendations for future directions.

Heart Failure (HF) is a serious emerging Public Health issue mainly in the high-income countries. In the USA, more than 6 million adults are affected. Despite the latest advances in device and pharmacological therapeutics, it still carries a huge burden, partially reflected in the annual healthcare cost of approximately $30 billion (2012) and the 5 year mortality rate of 50%. In this article, we review the medications, proven to significantly reduce mortality and morbidity in HF patients with structural myocardial disease and past or current symptoms, based on the latest North American HF guidelines. We, finally, perform a brief comparison between the former recommendations and the published 2016 HF guidelines by European Society of Cardiology.

BACKGROUND:Identification of the infarct-related artery (IRA) in patients with STEMI using coronary angiography (CA) is often based on the ECG and can be challenging in patients with severe multi-vessel disease. The current study aimed to determine how often percutaneous intervention (PCI) is performed in a coronary artery different from the artery supplying the territory of acute infarction on cardiac magnetic resonance imaging (CMR). METHODS:We evaluated 113 patients from the Reduction of infarct Expansion and Ventricular remodeling with Erythropoetin After Large myocardial infarction (REVEAL) trial, who underwent CMR within 4±2 days of revascularization. Blinded reviewers interpreted CA to determine the IRA and CMR to determine the location of infarction on a 17-segment model. In patients with multiple infarcts on CMR, acuity was determined with T2-weighted imaging and/or evidence of microvascular obstruction. RESULTS:A total of 5 (4%) patients were found to have a mismatch between the IRA identified on CMR and CA. In 4/5 cases, there were multiple infarcts noted on CMR. Thirteen patients (11.5%) had multiple infarcts in separate territories on CMR with 4 patients (3.5%) having multiple acute infarcts and 9 patients (8%) having both acute and chronic infarcts. CONCLUSIONS:In this select population of patients, the identification of the IRA by CA was incorrect in 4% of patients presenting with STEMI. Four patients with a mismatch had an acute infarction in more than one coronary artery territory on CMR. The role of CMR in patients presenting with STEMI with multi-vessel disease on CA deserves further investigation.

There is mounting evidence that communication and hand-off failures are a root cause of two-thirds of sentinel events in hospitals. Several studies have shown that non-standardized hand-offs have yielded poor patient outcomes and adverse events. At Stony Brook University Hospital, there were numerous reported adverse events related to poor hand-off during the transfer of patient responsibility from one resident caregiver to the next. A resident-conducted root cause analysis identified lack of a standardized hand-off process and formal training on safe and efficient hand-off among caregivers as key contributing factors. This quality improvement project used the PDSA methodology to test the use of a standardized method, the IPASS mnemonic, and compare it to our conventional hand-off method in our internal medicine residency program. The main goals of this study were to test the feasibility and effectiveness of a standardized I- PASS hand-off and to create a robust sustainability model that includes 1) integration of I-PASS handoff in the Electronic Medical Record (EMR), 2) direct observation of the hand-off process by faculty and senior residents, and 3) surveillance and reporting of hand-off compliance scores. Compared to hand-off with a conventional method, the use of the I-PASS method resulted in significantly fewer reported adverse events (χ2=4.8, df=1, p=0.04). I-PASS was successfully integrated into our EMR system and residents were mandated to use this as the sole method of hand-off. An EMR audit conducted six months after implementation revealed poor compliance, which ultimately led to the creation of a sustainability model that improved overall compliance from 60% to 100%.

The epidemiological, clinical, and societal implications of the heart failure (HF) epidemic cannot be overemphasized. Approximately half of all HF patients have HF with preserved ejection fraction (HFpEF). HFpEF is largely a syndrome of the elderly, and with aging of the population, the proportion of patients with HFpEF is expected to grow. Currently, there is no drug known to improve mortality or hospitalization risk for these patients. Besides mortality and hospitalization, it is imperative to realize that patients with HFpEF have significant impairment in their functional capacity and their quality of life on a daily basis, underscoring the need for these parameters to ideally be incorporated within a regulatory pathway for drug approval. Although attempts should continue to explore therapies to reduce the risk of mortality or hospitalization for these patients, efforts should also be directed to improve other patient-centric concerns, such as functional capacity and quality of life. To initiate a dialogue about the compelling need for and the challenges in developing such alternative endpoints for patients with HFpEF, the US Food and Drug Administration on November 12, 2015, facilitated a meeting represented by clinicians, academia, industry, and regulatory agencies. This document summarizes the discussion from this meeting.

Despite the rising prevalence of HF, new evidence-based novel therapies for patients with worsening HF remain lacking, e.g., safe inotropic therapies. Traditional inotropes increase contractility by altering intracellular calcium flux, a pathway that may be responsible for the multitude of adverse effects associated with current options. Omecamtiv mecarbil, a direct myosin activator, increases contractility through a distinct pathway by increasing the proportion of myosin heads that are bound to actin in a high-affinity state. Phase II clinical trials in patients with chronic HF with this agent seem promising. A phase III trial investigating this therapy has not yet been pursued to date.

INTRODUCTION/BACKGROUND:Teaching and learning patient safety require demonstration of competencies such as teamwork, communication skills, and recognition of systems error. This patient safety TBL simulation-training program was developed to fulfill core patient safety objectives outlined by the ACGME and ACGME Clinical Learning Environment Review Program. The goal of the program is to enhance patient safety and quality care concepts and facilitate hands-on teamwork skills and core attitudes towards patient safety. This program served as a mandatory part of the residency core curriculum. METHODS:It was delivered as a 3-hour workshop session during medicine resident orientation. The workshop included an introductory presentation, one TBL activity, and three 1-hour interprofessional simulated application cases using either high-fidelity mannequins or standardized patients. Following each application case activity, trainees participated in a postcase scenario debriefing moderated by faculty facilitators. RESULTS:A total of 76 trainees participated, and 20 interprofessional teams were created. An independent-samples t test revealed that the Group Readiness Assurance Test scores were significantly higher than the Individual Readiness Assurance Test scores. Although the Readiness for Interprofessional Learning Survey's Teamwork and Professional Identity subscale scores were higher postworkshop compared to preworkshop, the differences were not statistically significant. Over 90% of the participants agreed that the safety concepts they learned would likely improve the quality of care they provide to future patients. DISCUSSION/CONCLUSIONS:A simulation model centered on an interprofessional team can be used as an important training technique to teach health care professionals realistic, hands-on principles of patient safety.