Publications by authors named "David R Fischell"
Background: Increased pre-hospital delay during acute coronary syndrome (ACS) events contributes to worse outcome.
Objectives: The purpose of this study was to assess the effectiveness of an implanted cardiac monitor with real-time alarms for abnormal ST-segment shifts to reduce pre-hospital delay during ACS events.
Methods: In the ALERTS (AngeLmed Early Recognition and Treatment of STEMI) pivotal study, subjects at high risk for recurrent ACS events (n = 907) were randomized to control (Alarms OFF) or treatment groups for 6 months, after which alarms were activated in all subjects (Alarms ON).
Background/purpose: We update the pre-clinical and early clinical results using a novel endovascular approach, to perform chemical renal denervation, via peri-adventitial injection of micro-doses of dehydrated alcohol (ethanol-EtOH).
Methods/materials: A novel, three-needle delivery device (Peregrine™) was used to denervate the renal arteries of adult swine (n = 17) and in a first-in-man feasibility study (n = 18). In the pre-clinical testing EtOH was infused bilaterally with one infusion per renal artery into to the perivascular space, using EtOH doses of 0.
Aims: We report the use of a novel endovascular approach using chemical neurolysis, via periadventitial injection of dehydrated ethanol (EtOH) to perform renal artery denervation.
Methods And Results: A novel, three-needle delivery device was introduced into the renal arteries of adult swine using fluoroscopic guidance. EtOH was injected bilaterally with one injection per artery, via the three needles into the adventitial and periadventitial space, using EtOH doses 0.
Objectives: We report the first clinical studies of intracardiac ST-segment monitoring in ambulatory humans to alert them to significant ST-segment shifts associated with thrombotic occlusion.
Background: Despite improvements in door-to-balloon times, delays in symptom-to-door times of 2 to 3 h remain. Early alerting of the presence of acute myocardial infarction could prompt patients to seek immediate medical evaluation.
The AngelMed Guardian is an implantable medical device that records cardiac data and detects ischemic events using a standard pacemaker intracardiac lead positioned in the right ventricular apex. The Guardian has been implanted in 55 people in the United States and Brazil and is currently undergoing a Food and Drug Administration phase 2 pivotal trial in the United States. The Guardian detects acute ischemic events by analyzing ST-segment shifts.
View Article and Find Full Text PDFObjectives: The purpose of this study was to evaluate feasibility of using real-time, high-fidelity, intracardiac electrogram monitoring from a permanently implantable ischemia detection system (IIDS), with long-range telemetry capability to detect ST-segment shifts associated with acute or subacute coronary occlusion in a porcine model.
Background: Early identification of coronary occlusion with ST-segment elevation could profoundly accelerate the timing of revascularization and improve clinical outcomes.
Methods: This paper reports the first investigation using real-time, high-fidelity, intracardiac electrogram monitoring from a permanently IIDS, with long-range telemetry capability.
Background: Early identification of acute MI and prompt intervention can improve clinical outcomes. It would be valuable to identify a method that could allow the earliest possible detection of myocardial injury or ischemia.
Methods And Results: This article reports one of the first clinical investigations to examine the ability of an intracardiac right ventricular (RV) electrode to identify the early onset of myocardial ischemia/injury in a cohort of patients undergoing balloon occlusion of a coronary artery during percutaneous transluminal coronary angioplasty.