Abstract Background The STS/ACC Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration (FDA) approved transcatheter valve devices performed in the United ...States and is mandated as a condition of reimbursement by a Centers for Medicaid and Medicare Services (CMS) Objectives This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States. Methods Data for all patients receiving commercially approved devices from 2012 through December 31, 2015 are entered in the TVT Registry. Results The 54,782 TAVR patients demonstrated decreases in expected risk of 30-day operative mortality (STS PROM) 7% to 6% and TAVR PROM (TVT PROM) 4% to 3% (both p<.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9% and one-year mortality decreased from 25.8% to 21.6. However, 30-day post procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent TMC in 2015 were similar to 2013-14 patients with hospital mortality of 2% with mitral regurgitation reduced to gradient ≤ 2 in 87% of patients (p<.0001). The 349 patients who underwent MViV and MViR procedures were high risk with, an STS PROM for MVR of 11%. The observed hospital mortality was 7.2% and 30-day post procedure was 8.5%. Summary The TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies. Condensed Abstract The STS/ACC TVT Registry captures all Food and Drug Administration (FDA) approved transcatheter valve devices preformed in the United States and is mandated as a condition for reimbursement by the Centers for Medicare Services. TAVR patients’ expected risks of mortality and actual in-hospital mortality decreased. Transcatheter mitral clip procedures had a low mortality with reduced in mitral regurgitation to grade ≤ 2 in 87%. Mitral valve in valve or valve in ring patients were high risk for mortality, but actual hospital mortality was lower. The TVT Registry is an innovative registry that monitors quality, safety and trends of these evolving technologies
2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery Hillis, L. David, MD, FACC; Smith, Peter K., MD, FACC; Anderson, Jeffrey L., MD, FACC, FAHA ...
Journal of the American College of Cardiology,
12/2011, Letnik:
58, Številka:
24
Journal Article
Abstract Background In patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), studies have suggested that reduced left ventricular (LV) ejection fraction (LVEF) and ...low aortic valve gradient (AVG) are associated with worse long-term outcomes. Because these conditions commonly coexist, the extent to which they are independently associated with outcomes after TAVR is unknown. Objectives The purpose of this study was to evaluate the impact of LVEF and AVG on clinical outcomes after TAVR and to determine whether the effect of AVG on outcomes is modified by LVEF. Methods Using data from 11,292 patients who underwent TAVR as part of the Transcatheter Valve Therapies Registry, we examined rates of 1-year mortality and recurrent heart failure in patients with varying levels of LV dysfunction (LVEF <30% vs. 30% to 50% vs. >50%) and AVG (<40 mm Hg vs. ≥40 mm Hg). Multivariable models were used to estimate the independent effect of AVG and LVEF on outcomes. Results During the first year of follow-up after TAVR, patients with LV dysfunction and low AVG had higher rates of death and recurrent heart failure. After adjustment for other clinical factors, only low AVG was associated with higher mortality (hazard ratio: 1.21; 95% confidence interval: 1.11 to 1.32; p < 0.001) and higher rates of heart failure (hazard ratio: 1.52; 95% confidence interval: 1.36 to 1.69; p <0.001), whereas the effect of LVEF was no longer significant. There was no evidence of effect modification between AVG and LVEF with respect to either endpoint. Conclusions In this series of real-world patients undergoing TAVR, low AVG, but not LV dysfunction, was associated with higher rates of mortality and recurrent heart failure. Although these findings suggest that AVG should be considered when evaluating the risks and benefits of TAVR for individual patients, neither severe LV dysfunction nor low AVG alone or in combination provide sufficient prognostic discrimination to preclude treatment with TAVR.
Abstract Background Transcatheter mitral valve (MV) repair with the MitraClip received approval in 2013 for the treatment of prohibitive-risk patients with primary mitral regurgitation (MR). ...Objectives The aim of this study was to report the initial U.S. commercial experience with transcatheter MV repair. Methods Data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with this percutaneous mitral valve repair device were analyzed. Results Of 564 patients (56% men, median age 83 years), severe symptoms were present in 473 (86.0%). The median Society of Thoracic Surgeons Predicted Risk of Mortality scores for MV repair and replacement were 7.9% (interquartile range: 4.7% to 12.2%) and 10.0% (interquartile range: 6.3% to 14.5%), respectively. Frailty was noted in 323 patients (57.3%). Transcatheter MV repair was performed for degenerative disease, present in 90.8% of patients. Overall, MR was reduced to grade ≤2 in 93.0%. In-hospital mortality was 2.3%; 30-day mortality was 5.8%. Other 30-day events were stroke (1.8%), bleeding (2.6%), and device-related complications (1.4%). The median length of stay was 3 days (interquartile range: 1 to 6 days), with 84.0% patients discharged home. Overall, procedure success occurred in 90.6%. Variables associated with reduction in MR were end-diastolic dimension, MR severity, clip location, and case volume. Conclusions In this study of the initial commercial U.S. experience, it was found that procedural success was achieved in approximately 91% of patients, and the majority of patients were discharged home with moderate or less MR. These data support the effectiveness of this therapy in appropriately selected high-risk patients in a commercial setting. Further study is required to determine the long-term impact of transcatheter MV repair in this patient population.
Abstract Background In the PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) trial that evaluated patients with nonvalvular ...atrial fibrillation (NVAF), left atrial appendage (LAA) occlusion was noninferior to warfarin for stroke prevention, but a periprocedural safety hazard was identified. Objectives The goal of this study was to assess the safety and efficacy of LAA occlusion for stroke prevention in patients with NVAF compared with long-term warfarin therapy. Methods This randomized trial further assessed the efficacy and safety of the Watchman device. Patients with NVAF who had a CHADS2 (congestive heart failure, hypertension, age >75 years, diabetes mellitus, and previous stroke/transient ischemic attack) score ≥2 or 1 and another risk factor were eligible. Patients were randomly assigned (in a 2:1 ratio) to undergo LAA occlusion and subsequent discontinuation of warfarin (intervention group, n = 269) or receive chronic warfarin therapy (control group, n = 138). Two efficacy and 1 safety coprimary endpoints were assessed. Results At 18 months, the rate of the first coprimary efficacy endpoint (composite of stroke, systemic embolism SE, and cardiovascular/unexplained death) was 0.064 in the device group versus 0.063 in the control group (rate ratio 1.07 95% credible interval (CrI): 0.57 to 1.89) and did not achieve the prespecified criteria noninferiority (upper boundary of 95% CrI ≥1.75). The rate for the second coprimary efficacy endpoint (stroke or SE >7 days’ postrandomization) was 0.0253 versus 0.0200 (risk difference 0.0053 95% CrI: –0.0190 to 0.0273), achieving noninferiority. Early safety events occurred in 2.2% of the Watchman arm, significantly lower than in PROTECT AF, satisfying the pre-specified safety performance goal. Using a broader, more inclusive definition of adverse effects, these still were lower in PREVAIL (Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trial than in PROTECT AF (4.2% vs. 8.7%; p = 0.004). Pericardial effusions requiring surgical repair decreased from 1.6% to 0.4% (p = 0.027), and those requiring pericardiocentesis decreased from 2.9% to 1.5% (p = 0.36), although the number of events was small. Conclusions In this trial, LAA occlusion was noninferior to warfarin for ischemic stroke prevention or SE >7 days’ post-procedure. Although noninferiority was not achieved for overall efficacy, event rates were low and numerically comparable in both arms. Procedural safety has significantly improved. This trial provides additional data that LAA occlusion is a reasonable alternative to warfarin therapy for stroke prevention in patients with NVAF who do not have an absolute contraindication to short-term warfarin therapy.
Study objective Patients receiving warfarin or clopidogrel are considered at increased risk for traumatic intracranial hemorrhage after blunt head trauma. The prevalence of immediate traumatic ...intracranial hemorrhage and the cumulative incidence of delayed traumatic intracranial hemorrhage in these patients, however, are unknown. The objective of this study is to address these gaps in knowledge. Methods A prospective, observational study at 2 trauma centers and 4 community hospitals enrolled emergency department (ED) patients with blunt head trauma and preinjury warfarin or clopidogrel use from April 2009 through January 2011. Patients were followed for 2 weeks. The prevalence of immediate traumatic intracranial hemorrhage and the cumulative incidence of delayed traumatic intracranial hemorrhage were calculated from patients who received initial cranial computed tomography (CT) in the ED. Delayed traumatic intracranial hemorrhage was defined as traumatic intracranial hemorrhage within 2 weeks after an initially normal CT scan result and in the absence of repeated head trauma. Results A total of 1,064 patients were enrolled (768 warfarin patients 72.2% and 296 clopidogrel patients 27.8%). There were 364 patients (34.2%) from Level I or II trauma centers and 700 patients (65.8%) from community hospitals. One thousand patients received a cranial CT scan in the ED. Both warfarin and clopidogrel groups had similar demographic and clinical characteristics, although concomitant aspirin use was more prevalent among patients receiving clopidogrel. The prevalence of immediate traumatic intracranial hemorrhage was higher in patients receiving clopidogrel (33/276, 12.0%; 95% confidence interval CI 8.4% to 16.4%) than patients receiving warfarin (37/724, 5.1%; 95% CI 3.6% to 7.0%), relative risk 2.31 (95% CI 1.48 to 3.63). Delayed traumatic intracranial hemorrhage was identified in 4 of 687 (0.6%; 95% CI 0.2% to 1.5%) patients receiving warfarin and 0 of 243 (0%; 95% CI 0% to 1.5%) patients receiving clopidogrel. Conclusion Although there may be unmeasured confounders that limit intergroup comparison, patients receiving clopidogrel have a significantly higher prevalence of immediate traumatic intracranial hemorrhage compared with patients receiving warfarin. Delayed traumatic intracranial hemorrhage is rare and occurred only in patients receiving warfarin. Discharging patients receiving anticoagulant or antiplatelet medications from the ED after a normal cranial CT scan result is reasonable, but appropriate instructions are required because delayed traumatic intracranial hemorrhage may occur.
Stent Thrombosis Holmes, David R., MD; Kereiakes, Dean J., MD; Garg, Scot, MD ...
Journal of the American College of Cardiology,
10/2010, Letnik:
56, Številka:
17
Journal Article
Recenzirano
Odprti dostop
Intense investigation continues on the pathobiology of stent thrombosis (ST) because of its morbidity and mortality. Because little advance has been made in outcomes following ST, ongoing research is ...focused on further understanding predictive factors as well as ST frequency and timing in various patient subsets, depending upon whether a drug-eluting stent or bare-metal stent has been implanted. Although the preventive role of antiplatelet therapies remains unchallenged, new data on genomics and variability in response to antiplatelet therapy, as well as the effects of novel therapeutic agents and duration of therapy, have become available. The goal remains identification of patients at particularly increased risk of ST so that optimal prevention strategies can be developed and employed.
Study objective Field triage guidelines recommend that emergency medical services (EMS) providers consider transport of head-injured older adults with anticoagulation use to trauma centers. However, ...the triage patterns and the incidence of intracranial hemorrhage or neurosurgery in these patients are unknown. Our objective is to describe the characteristics and outcomes of older adults with head trauma who are transported by EMS, particularly for patients who do not meet physiologic, anatomic, or mechanism-of-injury (steps 1 to 3) field triage criteria but are receiving anticoagulant or antiplatelet medications. Methods This was a retrospective study at 5 EMS agencies and 11 hospitals (4 trauma centers, 7 nontrauma centers). Patients aged 55 years or older with head trauma who were transported by EMS were included. The primary outcome was the presence of intracranial hemorrhage. The secondary outcome was a composite measure of inhospital death or neurosurgery. Results Of the 2,110 patients included, 131 (6%) had intracranial hemorrhage and 41 (2%) had inhospital death or neurosurgery. There were 162 patients (8%) with steps 1 to 3 criteria. Of the remaining 1,948 patients without steps 1 to 3 criteria, 566 (29%) had anticoagulant or antiplatelet use. Of these patients, 52 (9%) had traumatic intracranial hemorrhage and 15 (3%) died or had neurosurgery. The sensitivity (adjusted for clustering by EMS agency) of steps 1 to 3 criteria was 19.8% (26/131; 95% confidence interval CI 5.5% to 51.2%) for identifying traumatic intracranial hemorrhage and 34.1% (14/41; 95% CI 9.9% to 70.1%) for death or neurosurgery. The additional criterion of anticoagulant or antiplatelet use improved the sensitivity for intracranial hemorrhage (78/131; 59.5%; 95% CI 42.9% to 74.2%) and death or neurosurgery (29/41; 70.7%; 95% CI 61.0% to 78.9%). Conclusion Relatively few patients met steps 1 to 3 triage criteria. For individuals who did not have steps 1 to 3 criteria, nearly 30% had anticoagulant or antiplatelet use. A relatively high proportion of these patients had intracranial hemorrhage, but a much smaller proportion died or had neurosurgery during hospitalization. Use of steps 1 to 3 triage criteria alone is not sufficient in identifying intracranial hemorrhage and death or neurosurgery in this patient population. The additional criterion of anticoagulant or antiplatelet use improves the sensitivity of the instrument, with only a modest decrease in specificity.
.1241 Preamble This document has been developed as an Expert Consensus Document (ECD) by the American College of Cardiology Foundation (ACCF), American Association for Thoracic Surgery (AATS), ...Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons in collaboration with the American Heart Association (AHA), American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Failure Society of America, Society of Cardiovascular Computed Tomography, Society of Cardiac Magnetic Resonance, Society of Cardiovascular Anesthesiologists, and Mended Hearts. Often the topic is the subject of considerable ongoing investigation. ...the reader should view the ECD as the best attempt of the ACCF and document cosponsors to inform and guide clinical practice in areas where rigorous evidence may not yet be available or evidence to date is not widely applied to clinical practice. Conference calls of the writing committee were confidential and attended only by committee members.\n AR = aortic regurgitation AS = aortic stenosis AVA = aortic valve area AVR = aortic valve replacement CAD = coronary artery disease CMR = cardiac magnetic resonance COPD = chronic obstructive pulmonary disease CT = computed tomography EF = ejection fraction EOA = effective orifice area EuroSCORE = European system for cardiac operative risk evaluation LV = left ventricular LVOT = left ventricular outflow pact MDCT = multidetector computed tomography NCDR = National Cardiovascular Data Registry PARTNER = Placement of Aortic Transcatheter Valve trial PH = pulmonary hypertension RV = right ventricular SOURCE = SAPIEN Aortic Biosprosthesis European Outcome registry STS = Society of Thoracic Surgeons TAVR = transcatheter aortic valve replacement TEE = transesophageal echocardiogram TTE = transthoracic echocardiography VARC = Valve Academic Research Consortium * This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant. A person is deemed to have a significant interest in a business if the interest represents ownership of >=5% of the voting stock or share of the business entity, or ownership of >=$10,000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person's gross income for the previous year. Names are listed in alphabetical order within each category of review.According to the ACCF/AHA, a person has a relevant relationship IF: a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) the person or a member of the person's household, has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document.AATS indicates American Association for Thoracic Surgery; ACCF, American College of Cardiology Foundation; ACE, Accreditation for Cardiovascular Excellence; AHA, American Heart Association; ASE, American Society of Echocardiography; DCRI, Duke Clinical Research Institute; EACTS, European Association for Cardio-Thoracic Surgery; HFSA, Heart Failure Society of America; NCDR-CARE, National Cardiovascular Data Registry-Carotid Artery Revascularization and Endarterectomy; NIH, National Institutes of Health; PARTNER, Placement of Aortic Transcatheter Valve Trial; PI, principal investigator; SCA, Society of Cardiovascular Anesthesiologists; SCAI, Society for Cardiovascular Angiography and Interventions; SCCT, Society of Cardiovascular Computed Tomography; SCMR, Society for Cardiovascular Magnetic Resonance; and STS, Society of Thoracic Surgeons.
Abstract The development of new transseptal transcatheter interventions for patients with structural heart disease is fueling increasing interest in transseptal puncture techniques. The authors ...review contemporary transseptal puncture indications and techniques and provide a step-by-step approach to challenging transseptal access and procedural complications.
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