A prospective, randomized clinical trial of hemodynamic support with impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: The PROTECT II study
O'Neill W.W.,University of Miami |
Kleiman N.S.,Methodist key Heart and Vascular Center |
Moses J.,Columbia University |
Dixon S.,Beaumont Hospital |
And 8 more authors.
Circulation | Year: 2012
BACKGROUND-: Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention with hemodynamic support may be feasible for these patients. Currently, there is no systematic comparative evaluation of hemodynamic support devices for this indication. METHODS AND RESULTS-: We randomly assigned 452 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease and severely depressed left ventricular function to intra-aortic balloon pump (IABP) (n=226) or Impella 2.5 (n=226) support during nonemergent high-risk percutaneous coronary intervention. The primary end point was the 30-day incidence of major adverse events. A 90-day follow-up was required, as well, by protocol. Impella 2.5 provided superior hemodynamic support in comparison with IABP, with maximal decrease in cardiac power output from baseline of -0.04±0.24 W in comparison with -0.14±0.27 W for IABP (P=0.001). The primary end point (30-day major adverse events) was not statistically different between groups: 35.1% for Impella 2.5 versus 40.1% for IABP, P=0.227 in the intent-to-treat population and 34.3% versus 42.2%, P=0.092 in the per protocol population. At 90 days, a strong trend toward decreased major adverse events was observed in Impella 2.5-supported patients in comparison with IABP: 40.6% versus 49.3%, P=0.066 in the intent-to-treat population and 40.0% versus 51.0%, P=0.023 in the per protocol population, respectively. CONCLUSIONS-: The 30-day incidence of major adverse events was not different for patients with IABP or Impella 2.5 hemodynamic support. However, trends for improved outcomes were observed for Impella 2.5-supported patients at 90 days. © 2012 American Heart Association, Inc.
Mcelrath T.F.,Brigham and Womens Hospital |
Fichorova R.N.,Brigham and Womens Hospital |
Allred E.N.,Neuroepidemiology Unit |
Hecht J.L.,Beth Israel Deaconess Hospital |
And 3 more authors.
American Journal of Obstetrics and Gynecology | Year: 2011
Objective: Disorders that lead to preterm delivery influence the fetal inflammatory response. Study Design: We calculated odds ratios of elevated concentrations of 25 blood proteins on the first postnatal day in 798 infants born before the 28th week and classified by the pregnancy disorder that lead to preterm delivery. Results: Concentrations of cytokines (IL-1β, IL-6, TNFα), cytokine receptors (IL-6R, TNF-R1, TNF-R2), systemic inflammatory proteins (CRP, SAA, MPO), chemokines (IL-8, MCP-1, MCP-4, MIP-1β, RANTES, I-TAC), adhesion molecules (ICAM-1, ICAM-3, VCAM-1, E-selectin), and metalloproteinases (MMP-1, MMP-9) were elevated in children delivered after preterm labor, membrane rupture, abruption, and cervical insufficiency, whereas such a pattern was not seen after preeclampsia or fetal indication/growth restriction. Inflammatory profiles were also associated with maternal vaginitis. Conclusion: The patterns of blood proteins in the newborn support the division of pregnancy disorders that lead to preterm delivery into those associated, and those not associated, with inflammation. © 2011 Mosby, Inc. All rights reserved.
Miller A.L.,Brigham and Womens Hospital |
Kramer D.B.,Beth Israel Deaconess Hospital |
Lewis E.F.,Brigham and Womens Hospital |
Koplan B.,Brigham and Womens Hospital |
And 2 more authors.
PACE - Pacing and Clinical Electrophysiology | Year: 2011
Background: While surgical epicardial lead placement is performed in a subset of cardiac resynchronization therapy patients, data comparing survival following surgical versus transvenous lead placement are limited. We hypothesized that surgical procedures would be associated with increased mortality risk. Methods: Long-term event-free survival was assessed for 480 consecutive patients undergoing surgical (48) or percutaneous (432) left ventricle (LV) lead placement at our institution from January 2000 to September 2008. Results: Baseline clinical and demographic characteristics were similar between groups. While there was no statistically significant difference in overall event-free survival (P = 0.13), when analysis was restricted to surgical patients with isolated surgical lead placement (n = 28), event-free survival was significantly lower in surgical patients (P = 0.015). There appeared to be an early risk (first approximately 3 months postimplantation) with surgical lead placement, primarily in LV lead-only patients. Event rates were significantly higher in LV lead-only surgical patients than in transvenous patients in the first 3 months (P = 0.006). In proportional hazards analysis comparing isolated surgical LV lead placement to transvenous lead placement, adjusted hazard ratios were 1.8 ([1.1,2.7] P = 0.02) and 1.3 ([1.0,1.7] P = 0.07) for the first 3 months and for the full duration of follow-up, respectively. Conclusions: Isolated surgical LV lead placement appears to carry a small but significant upfront mortality cost, with risk extending beyond the immediate postoperative period. Long-term survival is similar, suggesting those surviving beyond this period of early risk derive the same benefit as coronary sinus lead recipients. Further work is needed to identify risk factors associated with early mortality following surgical lead placement. ©2010, The Authors. Journal compilation ©2010 Wiley Periodicals, Inc.
Maski K.P.,Childrens Hospital Boston |
Sengupta S.,Beth Israel Deaconess Hospital |
Silvera M.,Childrens Hospital Boston |
Rivkin M.J.,Childrens Hospital Boston
Pediatric Neurology | Year: 2011
Marfan syndrome is an autosomal dominant connective tissue disorder commonly due to mutation of the fibrillin-1 (FBN-1) gene that causes disruption of elastic fibers in large- and medium-size arteries and predisposes to aneurysm formation and arterial dissection. Cardiovascular complications occur in most patients with Marfan syndrome, but interestingly, neurovascular complications of Marfan syndrome are rare. We present a novel case of an adolescent with Marfan syndrome with spontaneous intracranial cerebral artery dissection and ischemic stroke with hemorrhagic transformation. This case is novel in that it reports spontaneous intracranial dissection in a young patient with Marfan syndrome and highlights the rare intrinsic neurovascular complications that can occur in these patients. © 2011 Elsevier Inc. All rights reserved.
George M.,Ellis Hospital |
Delgaudio A.,Albany Medical College |
Salhanick S.D.,Beth Israel Deaconess Hospital
Pediatric Emergency Care | Year: 2010
Exertional rhabdomyolysis (ER) is a serious medical issue usually seen in individuals or patients after engaging in heavy exertion and physical activity. The incidence, natural course, and recurrence of ER are, by and large, unknown. Given the lack of rigorous scientific data that are specific for ER, most of the patients with ER receive treatment in an inpatient setting even with only a mild elevation of creatine phosphokinase (CPK) level. Often, patients receive inpatient treatment solely on the basis of elevated CPK (<3000 IU) even in the absence of other serious signs and symptoms of ER. We intent to describe 2 case reports that involve patients who developed ER after an intense physical exertion and were managed in an outpatient setting with close follow-up. In the discussion part, we point suggest that in patients with a relatively mild CPK elevation (<15,000 IU) and normal creatinine value and in the absence of factors such as profound dehydration, sickle cell trait, concomitant infectious cause, underlying metabolic syndrome, and current and ongoing use of analgesics, the complications after ER are low. Patients who develop ER, who can be reliably followed up, and who fulfills these criteria can be managed as outpatients. © 2010 by Lippincott Williams & Wilkins.