Sanjeev Bhavnani

U.S. Food and Drug Administration | FDA · Center for Devices and Radiological Health

Nanosensors are nanoscale devices that measure physical attributes and convert these signals into analyzable information. In preparation, for the impending reality of nanosensors in clinical practice, we confront important questions regarding the evidence supporting widespread device use. Our objectives are to demonstrate the value and implications...

Funding Acknowledgements Type of funding sources: Public hospital(s). Main funding source(s): Scripps Health Krueger Wyeth Grant Background ACS results from unstable atherosclerotic plaques. Current measures to assess risk do not consider the patient’s coronary atherosclerotic composition. This was a case control study using a prospective single-c...

Background Diagnosis of shockable rhythms leading to defibrillation remains integral to improving out‐of‐hospital cardiac arrest outcomes. New machine learning techniques have emerged to diagnose arrhythmias on ECGs. In out‐of‐hospital cardiac arrest, an algorithm within an automated external defibrillator is the major determinant to deliver defibr...

Human bodily mechanisms and functions produce low-frequency vibrations. Our ability to perceive these vibrations is limited by our range of hearing. However, in-ear infrasonic hemodynography (IH) can measure low-frequency vibrations (<20 Hz) created by vital organs as an acoustic waveform. This is captured using a technology that can be embedded in...

Background Phase space is a mechanical systems approach and large-scale data representation of an object in 3-dimensional space. Whether such techniques can be applied to predict left ventricular pressures non-invasively and at the point-of-care is unknown.Objective This study prospectively validated a phase space machine-learned approach based on...

Background Ventricular tachycardia (VT) is a potentially lethal condition that occurs intermittently. The aim of this study was to derive a risk prediction model for VT episodes detected on ≤30 day mobile cardiac telemetry using a 24 hour ambulatory ECG recording. Methods We included patients who were monitored for 2–30 full days in the USA using...

Introduction Elevated left ventricular end diastolic pressure (LVEDP) is a consequence of compromised left ventricular compliance and an important measure of myocardial dysfunction. An algorithm was developed to predict elevated LVEDP utilizing electro-mechanical (EM) waveform features. We examined the hierarchical clustering of selected features d...

Aim: The COVID-19 pandemic forced medical practices to augment healthcare delivery to remote and virtual services. We describe the results of a nationwide survey of cardiovascular professionals regarding telehealth perspectives. Materials & methods: A 31-question survey was sent early in the pandemic to assess the impact of COVID-19 on telehealth a...

The application of artificial intelligence (AI) to healthcare has garnered significant enthusiasm in recent years. Despite the adoption of new analytic approaches, medical education on AI is lacking. We aim to create a usable AI primer for medical education. We discuss how to generate a clinical question involving AI, what data are suitable for AI...

Consider these 2 scenarios: Two individuals with heart failure (HF) have recently established with your clinic and followed for medical management and risk stratification. One is a 62-year-old man with nonischemic cardiomyopathy due to viral myocarditis, an ejection fraction (EF) of 40%, occasional rate-limiting dyspnea, and comorbidities of atrial...

Introduction: The cardiovascular (CV) system produces low frequency, ‘infrasonic’, auditory vibrations during the cardiac cycle. Herein, we report the first-in-person validation of a novel earbud sensor to capture CV time intervals and the feasibility of non-invasive infrasonic hemodynography (IH) using the MindMics ® wireless earbuds for long term...

Background Widespread adoption of evidence-based guidelines and treatment pathways in ST-Elevation Myocardial Infarction (STEMI) patients has considerably improved cardiac survival and decreased the risk of recurrent myocardial infarction. However, survival outcomes appear to have plateaued over the last decade. The hope underpinning the current st...

Objectives To combat misinformation, engender trust and increase health literacy, we developed a culturally and linguistically appropriate virtual reality (VR) vaccination education platform using community-engaged approaches within a Somali refugee community. Design Community-based participatory research (CBPR) methods including focus group discu...

Funding Acknowledgements Type of funding sources: None. Background Nitroglycerin (GTN) results in improved CCTA image quality and diagnostic accuracy due to vasodilation and improved contrast density. Although studies have shown that sublingual (SL) GTN spray has greater vasodilation and faster onset and duration of action compared to SL tablet, i...

Background and Objective: Coronary artery disease (CAD) and heart failure are the most common cardiovascular diseases. Non-invasive diagnostic testing for CAD requires radiation, heart rate acceleration, and imaging infrastructure. Early detection of left ventricular dysfunction is critical in heart failure management, the best measure of which is...

The growing population of older adults (age ≥65 years) is expected to lead to higher rates of cardiovascular disease. The expansion of digital health (encompassing telehealth, telemedicine, mobile health, and remote patient monitoring), Internet access, and cellular technologies provides an opportunity to enhance patient care and improve health out...

The wide gap between the development of new healthcare technologies and their integration into clinical practice argues for a deeper understanding of how effective quality improvement can be designed to meet the needs of patients and their clinical teams. The COVID-19 pandemic has forced us to address this gap and create long-term strategies to bri...

Unless prompted by symptoms or change in clinical status, the appropriate use criteria considers cardiac stress testing (CST) within two years of percutaneous coronary intervention (PCI) and five years of coronary artery bypass grafting (CABG) to be rarely appropriate. Little is known regarding use and yield of CST after PCI or CABG. We studied 39,...

The rapid development of digital health devices has enabled patients to engage in their care to an unprecedented degree and holds the possibility of significantly improving the diagnosis, treatment and monitoring of many medical conditions. Combined with the emergence of artificial intelligence algorithms, biometric datasets produced from these dig...

Background: Cardiac and major vascular surgeries are common surgical procedures associated with high rates of postsurgical complications and related hospital readmission. In-hospital remote automated monitoring (RAM) and virtual hospital-to-home patient care systems have major potential to improve patient outcomes following cardiac and major vascul...

BACKGROUND Cardiac and major vascular surgeries are common surgical procedures associated with high rates of postsurgical complications and related hospital readmission. In-hospital remote automated monitoring (RAM) and virtual hospital-to-home patient care systems have major potential to improve patient outcomes following cardiac and major vascula...

Background: Data sharing accelerates scientific progress but sharing individual-level data while preserving patient privacy presents a barrier. Methods and results: Using pairs of deep neural networks, we generated simulated, synthetic participants that closely resemble participants of the SPRINT trial (Systolic Blood Pressure Trial). We showed...

A busy community cardiologist finished reading eight echocardiograms over lunch and started clinic at 1 pm. As three patients waited, “Jane,” a 45-year-old graphic designer was seen for “skipped heart beat.” She works about 50 h a week, exercises at the local gym, and enjoys eating a healthy diet. About 4 months ago Jane began experiencing her hear...

Background Data sharing accelerates scientific progress but sharing individual level data while preserving patient privacy presents a barrier. Methods and Results Using pairs of deep neural networks, we generated simulated, synthetic “participants” that closely resemble participants of the SPRINT trial. We showed that such paired networks can be t...

Worldwide, over 230 million adults have major noncardiac surgery each year. Although surgery can improve quality and duration of life, it can also precipitate major complications. Moreover, a substantial proportion of deaths occur after discharge. Current systems for monitoring patients postoperatively, on surgical wards and after transition to hom...

Background: Several publications and guidelines designate diabetes mellitus (DM) as a coronary artery disease (CAD) risk equivalent. The aim of this investigation was to examine DM cardiac risk equivalence from the perspective of stress SPECT myocardial perfusion imaging (MPI). Methods and results: We examined cardiovascular outcomes (cardiac de...

Sharing deidentified patient-level research data presents immense opportunities to all stakeholders involved in cardiology research and practice. Sharing data encourages the use of existing data for knowledge generation to improve practice, while also allowing for validation of disseminated research. In this review, we discuss key initiatives and p...

Available Open Access at the Journal of the American College of Cardiology http://www.onlinejacc.org/content/70/21/2696

Background: The appropriate use criteria considers cardiac stress testing within 2 years after percutaneous coronary intervention (PCI) to be rarely appropriate, unless prompted by symptoms or change in clinical status. Little is known about the patterns of cardiac stress testing after PCI in the single-payer Canadian healthcare system, where mech...

Objectives: This study sought to determine whether mobile health (mHealth) device assessments used as clinical decision support tools at the point-of-care can reduce the time to treatment and improve long-term outcomes among patients with rheumatic and structural heart diseases (SHD). Background: Newly developed smartphone-connected mHealth devi...

The confluence of science, technology, and medicine in our dynamic digital era has spawned new data applications to develop prescriptive analytics, to improve healthcare personalization and precision medicine, and to automate the reporting of health data for clinical decisions.1 Data science in health care has seen recent and rapid progress along 3...

Background: Tens of thousands of cardiac and vascular surgeries (CaVS) are performed on seniors in Canada and the United Kingdom each year to improve survival, relieve disease symptoms, and improve health-related quality of life (HRQL). However, chronic postsurgical pain (CPSP), undetected or delayed detection of hemodynamic compromise, complicati...

The convergence of science and technology in our dynamic digital era has resulted in the development of innovative digital health devices that allow easy and accurate characterization in health and disease. Technological advancements and the miniaturization of diagnostic instruments to modern smartphone-connected and mobile health (mHealth) devices...

Background Inappropriate shocks (IASs) from implantable cardioverter defibrillators (ICDs) are associated with decreased quality of life, but whether they increase healthcare utilization and treatment costs is unknown. We sought to determine the impact of IASs on subsequent healthcare utilization and treatment costs. Methods We conducted a case-con...

Aims Hyponatremia is commonly observed among patients with left ventricular (LV) dysfunction and is a marker for adverse outcomes. We aimed to determine the prognostic significance of pre-implant hyponatremia on the outcomes of death, acute decompensated heart failure (ADHF) and appropriate implantable cardioverter-defibrillator (ICD) therapy for v...

Thyroid stimulating hormone (TSH) abnormalities have been associated with various cardiac arrhythmias. Effect of TSH abnormalities on mortality and implantable cardioverter defibrillators (ICD) behavior in patients with cardiomyopathy has not been investigated. Our ICD database includes 1,445 patients between December 1997 and January 2008. TSH lev...

Current guidelines consider the implantation of an implantable cardioverter defibrillator (ICD) a class III indication in patients with a life expectancy of <1 year. An evaluation of concomitant noncardiac conditions may identify patients whom may not derive benefit with ICD therapy. We sought to evaluate the association of the Charlson comorbidity...

Background: In experimental models, ranolazine exerts a synergistic effect which enhances amiodarone's potential to suppress atrial fibrillation (AF). The clinical effect of ranolazine added to amiodarone for AF conversion has only undergone minimal investigation. Purpose: This study compared the safety and effectiveness of ranolazine in combinatio...

Background: Several meta-analyses of the implantable cardioverter-defibrillator (ICD) clinical trials have demonstrated that while men derived a mortality reduction with prophylactic ICD implantation, women did not. These trials also observed that women receive less appropriate ICD shock therapy compared to men. We aimed to investigate this "gende...

Bidirectional ventricular tachycardia (BVT) is an uncommon type of polymorphic ventricular tachycardia (PVT) with alternating polarity of the QRS complex most commonly described digitalis toxicity. Recent data has demonstrated the possible molecular basis of this electrocardiographic phenomenon. To our knowledge this is the first reported case of B...

Background: Diabetic patients are known to have higher cardiovascular event rates than non-diabetics. However, data regarding the referral pattern for cardiac catheterization (CC) or coronary revascularization after SPECT MPI in diabetic and non-diabetic patients with no known CAD are limited.

Therapeutic hypothermia improves neurologic outcomes in patients resuscitated from cardiac arrest due to ventricular fibrillation. However, its role in patients with cardiac arrest due to non-shockable rhythms (pulseless electrical activity (PEA) and asystole) is unclear. We hypothesized that therapeutic hypothermia favorably impacts neurologic out...

Background: Therapeutic hypothermia (TH) is demonstrated to improve neurologic outcomes after cardiac arrest (CA). Our objective is to develop a model that provides predictive accuracy for survival with a good neurologic recovery (GNR) after TH.