Randomized Pilot Clinical Trial of Early Coronary Angiography Versus No Early Coronary Angiography After Cardiac Arrest Without ST-Segment Elevation: The PEARL Study.

BACKGROUND: The benefit of emergency coronary angiography after resuscitation from out-of-hospital cardiac arrest is uncertain for patients without ST-segment elevation. The aim of this randomized trial was to evaluate the efficacy and safety of early coronary angiography and to determine the prevalence of acute coronary occlusion in resuscitated patients with out-of-hospital cardiac arrest without ST-segment elevation. METHODS: Adult (>18 years) comatose survivors without ST-segment elevation after resuscitation from out-of-hospital cardiac arrest were prospectively randomized in a 1:1 fashion under exception to informed consent regulations to early coronary angiography versus no early coronary angiography in this multicenter study. Early angiography was defined as ≤120 minutes from arrival at the percutaneous coronary intervention-capable facility. The primary end point was a composite of efficacy and safety measures, including efficacy measures of survival to discharge, favorable neurologic status at discharge (Cerebral Performance Category score ≤2), echocardiographic measures of left ventricular ejection fraction >50%, and a normal regional wall motion score of 16 within 24 hours of admission. Adverse events included rearrest, pulmonary edema on chest x-ray, acute renal dysfunction, bleeding requiring transfusion or intervention, hypotension (systolic arterial pressure ≤90 mm Hg), and pneumonia. Secondary end points included the incidence of culprit vessels with acute occlusion. RESULTS: The study was terminated prematurely before enrolling the target number of patients. A total of 99 patients were enrolled from 2015 to 2018, including 75 with initially shockable rhythms. Forty-nine patients were randomized to early coronary angiography. The primary end point of efficacy and safety was not different between the 2 groups (55.1% versus 46.0%; P=0.64). Early coronary angiography was not associated with any significant increase in survival (55.1% versus 48.0%; P=0.55) or adverse events (26.5% versus 26.0%; P=1.00). Early coronary angiography revealed a culprit vessel in 47%, with a total of 14% of patients undergoing early coronary angiography having an acutely occluded culprit coronary artery. CONCLUSIONS: This underpowered study, when considered together with previous clinical trials, does not support early coronary angiography for comatose survivors of cardiac arrest without ST elevation. Whether early detection of occluded potential culprit arteries leads to interventions that improve outcomes requires additional study. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02387398.

Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction.

BACKGROUND: In ST-segment-elevation myocardial infarction (STEMI), infarct size correlates directly with heart failure and mortality. Preclinical testing has shown that, in comparison with reperfusion alone, mechanically unloading the left ventricle (LV) before reperfusion reduces infarct size and that 30 minutes of unloading activates a cardioprotective program that limits reperfusion injury. The DTU-STEMI pilot trial (Door-To-Unload in STEMI Pilot Trial) represents the first exploratory study testing whether LV unloading and delayed reperfusion in patients with STEMI without cardiogenic shock is safe and feasible. METHODS: In a multicenter, prospective, randomized exploratory safety and feasibility trial, we assigned 50 patients with anterior STEMI to LV unloading by using the Impella CP followed by immediate reperfusion (U-IR) versus delayed reperfusion after 30 minutes of unloading (U-DR). The primary safety outcome was a composite of major adverse cardiovascular and cerebrovascular events at 30 days. Efficacy parameters included the assessment of infarct size by using cardiac magnetic resonance imaging. RESULTS: All patients completed the U-IR (n=25) or U-DR (n=25) protocols with respective mean door-to-balloon times of 72 versus 97 minutes. Major adverse cardiovascular and cerebrovascular event rates were not statistically different between the U-IR versus U-DR groups (8% versus 12%, respectively, P=0.99). In comparison with the U-IR group, delaying reperfusion in the U-DR group did not affect 30-day mean infarct size measured as a percentage of LV mass (15±12% versus 13±11%, U-IR versus U-DR, P=0.53). CONCLUSIONS: We report that LV unloading using the Impella CP device with a 30-minute delay before reperfusion is feasible within a relatively short time period in anterior STEMI. The DTU-STEMI pilot trial did not identify prohibitive safety signals that would preclude proceeding to a larger pivotal study of LV unloading before reperfusion. An appropriately powered pivotal trial comparing LV unloading before reperfusion to the current standard of care is required. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03000270.

Novel technique of performing multivessel PCI through an Impella sheath.

A 69-year-old woman with diabetes was found to have multi-vessel coronary artery disease and underwent 5-vessel coronary artery bypass grafting. Patient had persistent cardiogenic shock postoperatively despite intra-aortic balloon pump and escalating pressor requirements. Electrocardiogram showed new ischemic changes and the patient was urgently taken to the catheterization lab for coronary angiography and placement of an Impella CP for higher degree of hemodynamic support via the left femoral artery. Due to limitations in vascular access the Impella CP sheath was utilized for vascular access for diagnostic angiography and coronary intervention concurrently with ongoing Impella CP support. The first obtuse marginal had severe proximal disease and was treated with percutaneous coronary intervention (PCI) with a drug eluting stent. To our knowledge, this case is the first in which successful diagnostic angiography as well as multi-vessel PCI was performed via an Impella sheath while concurrently using the percutaneous mechanical circulatory support system of the Impella CP. Multiple guide catheters and a pigtail catheter were successfully passed via the Impella CP sheath to perform PCI. This novel method of vascular access could be an important tool to use in high-risk patients with limitations in access sites and decrease potential bleeding complications by limiting the number of arterial punctures.

Mitral valve replacement complicated by iatrogenic left ventricular outflow obstruction and paravalvular leak: case report and review of literature.

BACKGROUND: Left ventricular outflow tract (LVOT) obstruction and paravalvular leak (PVL) are relatively uncommon, but are serious complications of prosthetic valve replacement. CASE PRESENTATION: We present a case that displays the unique therapeutic challenges of treating a patient who developed both LVOT obstruction and mitral PVL after undergoing surgical aortic and mitral valve replacement (MVR). We also describe the use of alcohol septal ablation and albumin-glutaraldehyde (BioGlue) for septal ablation to percutaneously treat the patient's LVOT obstruction, followed by use of an Amplatzer vascular plug for percutaneous closure of an antero-medial mitral PVL associated with severe regurgitation. CONCLUSION: Percutaneous interventional management of these entities may be considered as an initial therapeutic option, especially in high-risk patients with significant morbidity and mortality of repeat surgical operations.

Treatment of an iatrogenic femoral artery pseudoaneurysm with concomitant arteriovenous fistula with percutaneous implantation of an Amplatzer vascular plug.

Iatrogenic pseudoaneurysms can occur following percutaneous cardiac and peripheral procedures. There are multiple modalities available for the treatment of pseudoaneurysms including ultrasound guided compression repair, ultrasound guided thrombin injection, or endovascular repair with covered stent placement. If these methods are not indicated or unsuccessful, patients typically require open surgical repair. We report a case of a woman with a post-procedural pseudoaneurysm with concomitant arteriovenous fistula who was treated percutaneously with the implantation of an Amplatzer vascular plug. This novel technique was safe and effective and allowed our patient to avoid the morbidity and mortality associated with surgical repair.

Transcatheter patent foramen ovale closure versus medical therapy for cryptogenic stroke: a meta-analysis of randomized clinical trials.

BACKGROUND: There is an association between cryptogenic stroke and patent foramen ovale (PFO). The optimal treatment strategy for secondary prevention remains unclear. The purpose of this study was to analyze aggregate data examining the safety and efficacy of transcatheter device closure versus standard medical therapy in patients with PFO and cryptogenic stroke. METHODS: A search of published data identified 3 randomized clinical trials for inclusion. The primary outcome was a composite end-point of death, stroke and transient-ischemic attack (TIA). Pre-defined subgroup analysis was performed with respect to baseline characteristics including age, sex, atrial septal aneurysm and shunt size. Data was synthesized using a random effects model and results presented as hazard ratios (HRs) with 95% confidence intervals (CIs). RESULTS: A cohort of 2,303 patients with a history of cryptogenic stroke and PFO were randomized to device closure (n = 1150) and medical therapy (n = 1153). Mean follow-up was 2.5 years. Transcatheter closure was not superior to medical therapy in the secondary prevention of stroke or TIA in intention-to-treat analysis (HR: 0.66, 95% CI: 0.43 to 1.01; p = 0.056). However, the results were statistically significant using per-protocol analysis (HR: 0.64, 95% CI: 0.41 to 0.98; p = 0.043). Males had significant benefit with device closure (HR: 0.48, 95% CI: 0.24 to 0.96; p = 0.038). CONCLUSIONS: In this meta-analysis, using intention-to-treat analysis, transcatheter device closure of PFO was not superior to standard medical therapy in the secondary prevention of cryptogenic stroke. Transcatheter closure was superior using per-protocol analysis.

Aortic valve disorders and left ventricular assist devices.

Aortic valve disorders are important considerations in advanced heart failure patients being evaluated for left ventricular assist devices (LVAD) and those on LVAD support. Aortic insufficiency (AI) can be present prior to LVAD implantation or develop de novo during LVAD support. It is usually a progressive disorder and can lead to impaired LVAD effectiveness and heart failure symptoms. Severe AI is associated with worsening hemodynamics, increased hospitalizations, and decreased survival in LVAD patients. Diagnosis is made with echocardiographic, device assessment, and/or catheterization studies. Standard echocardiographic criteria for AI are insufficient for accurate diagnosis of AI severity. Management of pre-existing AI includes aortic repair or replacement at the time of LVAD implant. Management of de novo AI on LVAD support is challenging with increased risks of repeat surgical intervention, and percutaneous techniques including transcatheter aortic valve replacement are assuming greater importance. In this manuscript, we provide a comprehensive approach to contemporary diagnosis and management of aortic valve disorders in the setting of LVAD therapy.

Atherosclerotic inferior mesenteric artery stenosis resulting in large intestinal hypoperfusion: a paradigm shift in the diagnosis and management of symptomatic chronic mesenteric ischemia.

Symptomatic chronic mesenteric ischemia results from intestinal hypoperfusion and is classically thought to result from involvement of two or more mesenteric arteries. The celiac artery and superior mesenteric artery are most frequently implicated in this disease process, and their involvement usually results in symptoms of small intestinal ischemia. Symptomatic chronic mesenteric ischemia resulting predominantly from inferior mesenteric artery involvement has largely been overlooked but does gives rise to its own, unique clinical presentation with symptoms resulting from large intestinal ischemia. We present four patients with atherosclerotic inferior mesenteric artery stenosis with symptomatic chronic mesenteric ischemia that have unique clinical presentations consistent with large intestinal ischemia that resolved following percutaneous endovascular treatment of the inferior mesenteric artery stenosis. These cases represent a novel approach to the diagnosis and management of this disease process and may warrant a further subclassification of chronic mesenteric ischemia into chronic small intestinal ischemia and chronic large intestinal ischemia.

Percutaneous left axillary artery approach for Impella 2.5 liter circulatory support for patients with severe aortoiliac arterial disease undergoing high-risk percutaneous coronary intervention.

The use of the Impella 2.5 liter (L) device for hemodynamic support has been well described. The typical access site for the Impella 2.5 L device is the femoral artery. The use of the axillary and subclavian artery has been described via surgical cut down for the Impella 5 L device when femoral artery access is not possible. In patients with severe aortoiliac disease and difficult anatomy the femoral artery access for the Impella 2.5 L device is not feasible. We describe the successful percutaneous use of the Impella 2.5 L device for hemodynamic support via the left axillary artery in 2 patients undergoing high-risk PCI with concomitant severe aortoiliac disease.

Early Experience with the HeartMate Percutaneous Heart Pump from the SHIELD II Trial.

The HeartMate Percutaneous Heart Pump (PHP) is a novel circulatory support catheter delivering a self-expanding 24 French impeller across the aortic valve. The SHIELD II trial compares outcomes among heart failure patients undergoing high-risk percutaneous coronary intervention (HR-PCI) with the PHP versus Impella systems. The trial was halted in 2017 due to device malfunctions. We aimed to describe procedural, hemodynamic, and clinical outcomes among HR-PCI patients treated with PHP as part of the SHIELD II trial roll-in phase. Procedural, hemodynamic, and 90 day outcomes were assessed among patients undergoing HR-PCI with a left ventricular ejection fraction ≤35% and last patent coronary conduit, unprotected left main disease, or significant three vessel disease. The primary endpoint was the 90 day composite of cardiovascular death, myocardial infarction, stroke, repeat revascularization, major bleeding, new/worsening aortic regurgitation, and severe hypotension. Among 75 roll-in phase patients, PHP support duration was 101 ± 53 minutes with 2.5 ± 1.4 coronary lesions treated per patient. Compared with predevice values, the PHP system increased cardiac power and mean arterial pressure. Maximum recorded device flows were 0.4-6.2 L/minute with 26% (n = 19/73) and 9.6% (n = 7/73) of patients achieving peak flows above 3.5 or 5.0 L/minute, respectively. Five PHP device malfunction events (6.7%) were observed. At 90 days, the composite endpoint occurred in 24.3% (18/74) of patients. Early PHP experience demonstrated successful device performance in the majority of enrolled patients; however, unexpected malfunctions led to device revision. Completion of the SHIELD II trial will be required to confirm the safety and efficacy of this iteration of the PHP system in HR-PCI.