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Glower D.D.,Duke University | Kar S.,Cedars Sinai Medical Center | Trento A.,Cedars Sinai Medical Center | Lim D.S.,University of Virginia | And 11 more authors.
Journal of the American College of Cardiology | Year: 2014

Background The EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High-Risk registry and REALISM Continued Access Study High-Risk Arm are prospective registries of patients who received the MitraClip device (Abbott Vascular, Santa Clara, California) for mitral regurgitation (MR) in the United States. Objectives The purpose of this study was to report 12-month outcomes in high-risk patients treated with the percutaneous mitral valve edge-to-edge repair. Methods Patients with grades 3 to 4+ MR and a surgical mortality risk of ≥12%, based on the Society of Thoracic Surgeons risk calculator or the estimate of a surgeon coinvestigator following pre-specified protocol criteria, were enrolled. Results In the studies, 327 of 351 patients completed 12 months of follow-up. Patients were elderly (76 ± 11 years of age), with 70% having functional MR and 60% having prior cardiac surgery. The mitral valve device reduced MR to ≤2+ in 86% of patients at discharge (n = 325; p < 0.0001). Major adverse events at 30 days included death in 4.8%, myocardial infarction in 1.1%, and stroke in 2.6%. At 12 months, MR was ≤2+ in 84% of patients (n = 225; p < 0.0001). From baseline to 12 months, left ventricular (LV) end-diastolic volume improved from 161 ± 56 ml to 143 ± 53 ml (n = 203; p < 0.0001) and LV end-systolic volume improved from 87 ± 47 ml to 79 ± 44 ml (n = 202; p < 0.0001). New York Heart Association functional class improved from 82% in class III/IV at baseline to 83% in class I/II at 12 months (n = 234; p < 0.0001). The 36-item Short Form Health Survey physical and mental quality-of-life scores improved from baseline to 12 months (n = 191; p < 0.0001). Annual hospitalization rate for heart failure fell from 0.79% pre-procedure to 0.41% post-procedure (n = 338; p < 0.0001). Kaplan-Meier survival estimate at 12 months was 77.2%. Conclusions The percutaneous mitral valve device significantly reduced MR, improved clinical symptoms, and decreased LV dimensions at 12 months in this high-surgical-risk cohort. (Endovascular Valve Edge-to-Edge REpair STudy [EVERESTIIRCT]; NCT00209274). © 2014 By The American College of Cardiology Foundation Published By Elsevier Inc. Source


Stone G.W.,Columbia University Medical Center | Witzenbichler B.,Charite Campus Benjamin Franklin | Weisz G.,Columbia University Medical Center | Rinaldi M.J.,Sanger Heart and Vascular Institute | And 13 more authors.
The Lancet | Year: 2013

Background The relation between platelet reactivity and stent thrombosis, major bleeding, and other adverse events after coronary artery implantation of drug-eluting stents has been incompletely characterised. We aimed to determine the relation between platelet reactivity during dual therapy with aspirin and clopidogrel and clinical outcomes after successful coronary drug-eluting stent implantation. Methods ADAPT-DES was a prospective, multicentre registry of patients successfully treated with one or more drugeluting stents and given aspirin and clopidogrel at 10-15 US and European hospitals. We assessed platelet reactivity in those patients after successful percutaneous coronary intervention using VerifyNow point-of-care assays, and assigned different cutoffs to define high platelet reactivity. The primary endpoint was definite or probable stent thrombosis; other endpoints were all-cause mortality, myocardial infarction, and clinically relevant bleeding. We did a propensity-adjusted multivariable analysis to determine the relation between platelet reactivity and subsequent adverse events. This study is registered with ClinicalTrials.gov, number NCT00638794. Findings Between Jan 7, 2008, and Sept 16, 2010, 8665 patients were prospectively enrolled at 11 sites, of which 8583 were eligible. At 1-year follow-up, stent thrombosis had occurred in 70 (0·8%) patients, myocardial infarction in 269 (3·1%), clinically relevant bleeding in 531 (6·2%), and death in 161 (1·9%) patients. High platelet reactivity on clopidogrel was strongly related to stent thrombosis (adjusted HR 2·49 [95% CI 1·43-4·31], p=0·001) and myocardial infarction (adjusted HR 1·42 [1·09-1·86], p=0·01), was inversely related to bleeding (adjusted HR 0·73 [0·61- 0·89], p=0·002), but was not related to mortality (adjusted HR 1·20 [0·85-1·70], p=0·30). High platelet reactivity on aspirin was not significantly associated with stent thrombosis (adjusted HR 1·46 [0·58-3·64], p=0·42), myocardial infarction, or death, but was inversely related to bleeding (adjusted HR 0·65 [0·43-0·99], p=0·04). Interpretation The findings from this study emphasise the counter-balancing effects of haemorrhagic and ischaemic complications after stent implantation, and suggest that safer drugs or tailored strategies for the use of more potent agents must be developed if the benefits of greater platelet inhibition in patients with cardiovascular disease are to be realised. Source


Powell B.D.,Sanger Heart and Vascular Institute | Saxon L.A.,University of Southern California | Boehmer J.P.,Penn State Milton rshey Medical Center | Day J.D.,Intermountain Medical Center | And 5 more authors.
Journal of the American College of Cardiology | Year: 2013

Objectives This study sought to determine if the risk of mortality associated with inappropriate implantable cardioverter-defibrillator (ICD) shocks is due to the underlying arrhythmia or the shock itself. Background Shocks delivered from ICDs are associated with an increased risk of mortality. It is unknown if all patients who experience inappropriate ICD shocks have an increased risk of death. Methods We evaluated survival outcomes in patients with an ICD and a cardiac resynchronization therapy defibrillator enrolled in the LATITUDE remote monitoring system (Boston Scientific Corp., Natick, Massachusetts) through January 1, 2010. First shock episode rhythms from 3,809 patients who acutely survived the initial shock were adjudicated by 7 electrophysiologists. Patients with a shock were matched to patients without a shock (n = 3,630) by age at implant, implant year, sex, and device type. Results The mean age of the study group was 64 ± 13 years, and 78% were male. Compared with no shock, there was an increased rate of mortality in those who received their first shock for monomorphic ventricular tachycardia (hazard ratio [HR]: 1.65, p < 0.0001), ventricular fibrillation/polymorphic ventricular tachycardia (HR: 2.10, p < 0.0001), and atrial fibrillation/flutter (HR: 1.61, p = 0.003). In contrast, mortality after first shocks due to sinus tachycardia and supraventricular tachycardia (HR: 0.97, p = 0.86) and noise/artifact/oversensing (HR: 0.91, p = 0.76) was comparable to that in patients without a shock. Conclusions Compared with no shock, those who received their first shock for ventricular rhythms and atrial fibrillation had an increased risk of death. There was no significant difference in survival after inappropriate shocks for sinus tachycardia or noise/artifact/oversensing. In this study, the adverse prognosis after first shock appears to be more related to the underlying arrhythmia than to an adverse effect from the shock itself. © 2013 by the American College of Cardiology Foundation Published by Elsevier Inc. Source


Stamou S.C.,University of Iowa | Williams M.L.,University of Louisville | Gunn T.M.,University of Iowa | Hagberg R.C.,Hartford Hospital | And 2 more authors.
Journal of Thoracic and Cardiovascular Surgery | Year: 2015

Objective: The purpose of the present study was to evaluate the early clinical outcomes of aortic root surgery in the United States. Methods: The Society of Thoracic Surgeons database was queried to identify all patients who had undergone aortic root replacement from 2004 to early 2010 (n = 13,743). The median age was 58 years (range, 18-96); 3961 were women (29%) and 12,059 were white (88%). The different procedures included placement of a mechanical valve conduit (n = 4718, 34%), stented pericardial (n = 879, 6.4%) or porcine (n = 478, 3.5%) bioprosthesis, stentless root (n = 4309, 31%), homograft (n = 498, 3.6%), and valve sparing root replacement (n = 1918, 14%). Results: The median number of aortic root surgeries per site was 2, and only 5%of sites performed>16 aortic root surgeries annually. An increased trend to use biostented (porcine or pericardial) valves during the study period (7%in 2004 vs 14%in 2009). The operative (raw) mortality was greater among the patients with aortic stenosis (6.2%) who had undergone aortic root replacement, independent of age. Mortality was greater in patients who had undergone concomitant valve or coronary artery bypass grafting or valve surgery (21%). The lowest operative mortality was observed in patients who had undergone aortic valve sparing procedures (1.9%). Conclusions: Most cardiac centers performed aortic root surgery in small volumes. The unadjusted operative mortality was greater for patients>80 years old and those with aortic stenosis, regardless of age. Valve sparing root surgery was associated with the lowest mortality. A trend was seen toward an increased use of stented tissue valves from 2004 to 2009. Copyright © 2015 by The American Association for Thoracic Surgery. Source


Lobdell K.W.,Sanger Heart and Vascular Institute | Stamou S.,Michigan State University | Sanchez J.A.,University of Connecticut
Surgical Clinics of North America | Year: 2012

Health-acquired infection (HAI) is defined as a localized or systemic condition resulting from an adverse reaction to the presence of infectious agents or its toxins. This article focuses on HAIs that are well studied, common, and costly (direct, indirect, and intangible). The HAIs reviewed are catheter-related bloodstream infection, ventilator-associated pneumonia, surgical site infection, and catheter-associated urinary tract infection. This article excludes discussion of Clostridium difficile infections and vancomycin-resistant Enterococcus. © 2012 Elsevier Inc. Source

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