[Show abstract][Hide abstract] ABSTRACT: A meta-analysis was performed to evaluate the risk of major bleeding with the use of New Oral Anticoagulants (NOACs).Methods
Randomized controlled trials (RCTs) comparing NOACs (rivaroxaban, dabigatran, apixaban, edoxaban and darexaban) with comparators were selected.ResultsFifty trials included 155,537 patients. Pooled analysis of all NOACs for all indications together demonstrated no significant difference between NOACs and comparators for risk of major bleeding (odds ratio [OR] 0.93, 95% CI 0.79–1.09). Pooled analysis also showed that NOACs caused significantly less major bleeding compared to vitamin K antagonists (VKA) (0.77, 0.64–0.91). The analysis for individual NOACs showed risk of major bleeding were not different with rivaroxaban, apixaban or dabigatran compared to pharmacologically active comparators or VKA. Indication specific analysis showed that NOACs were associated with significantly higher major bleeding after hip surgery (1.43, 1.02–1.99), in patients with acute coronary syndrome (ACS), (compared against placebo) (2.89, 2.01–4.14), and for medically ill patients (2.79, 1.69–4.60). For the treatment of acute venous thromboembolism (VTE) or pulmonary embolism (PE), NOACs were associated with significantly less bleeding (0.63, 0.44–0.90). No significant difference was found between NOACs and comparators in treatment of atrial fibrillation and for extended treatment of VTE.Conclusions
Risk of major bleeding with new oral anticoagulants varies with their indication for use. New agents may be associated with comparatively less major bleeding compared to VKA. NOAC may increase the risk of major bleeding after hip surgery, ACS and acute medically ill patients; but may be associated with less bleeding in treatment of acute VTE/PE.
[Show abstract][Hide abstract] ABSTRACT: Recent studies have suggested that transcatheter aortic valve replacement (TAVR) may have superior outcomes compared with aortic valve replacement (AVR) for high-risk patients with significant mitral regurgitation (MR). Considering significant MR is frequently addressed with a mitral valve repair or replacement (MVR) at the time of open aortic valve replacement, this study compares TAVR and AVR/MVR in propensity-matched pairs of patients with significant MR.
[Show abstract][Hide abstract] ABSTRACT: Vascular complications after transfemoral transcatheter aortic valve replacement are common and associated with significant morbidity and mortality. Little is known about the effect of access approach on vascular complications.
[Show abstract][Hide abstract] ABSTRACT: To systematically examine discontinuation rates with new US Food and Drug Administration-approved oral anticoagulants (NOACs) in patients with various indications for long-term anticoagulation.
Mayo Clinic Proceedings 07/2014; 89(7):896-907. · 5.79 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Thrombolytic therapy may be beneficial in the treatment of some patients with pulmonary embolism. To date, no analysis has had adequate statistical power to determine whether thrombolytic therapy is associated with improved survival, compared with conventional anticoagulation.
JAMA The Journal of the American Medical Association 06/2014; 311(23):2414-21. · 29.98 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Direct transaortic (TAo) approach for transcatheter aortic valve replacement (TAVR) in patients with symptomatic, severe aortic stenosis (AS) with prohibitive transfemoral access is being increasingly performed. Furthermore, concomitant catheter-based procedures such as percutaneous coronary intervention (PCI) are also being increasingly performed during TAVR. We report a single-stage, catheter-based treatment of both critical AS and descending thoracic aortic aneurysm (DTA) by performing TAVR with concomitant thoracic aortic endovascular repair (TEVAR) through direct TAo access via a minimally invasive partial sternotomy approach. To our knowledge, this is the first report of a "hybrid" TAVR + TEVAR.
The Annals of thoracic surgery 02/2014; 97(2):696-698. · 3.45 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: This study sought to characterize usage and outcomes of carotid stenting platforms.
A variety of stents and embolic protection devices (EPDs) are used for carotid artery stenting. Little is known about current usage patterns and differences in outcomes with these devices.
We analyzed 12,135 consecutive carotid stent procedures in the NCDR (National Cardiovascular Data Registry) CARE (Carotid Artery Revascularization and Endarterectomy) registry performed between January 1, 2007 and March 31, 2012. We compared baseline characteristics and crude and multivariable-adjusted rates of in-hospital combined death/stroke among patients treated with Acculink/Accunet (Abbott Laboratories, Abbott Park, Illinois), Xact/Emboshield (Abbott), and Precise/Angioguard (Cordis Corporation, Bridgewater, New Jersey) stent/EPD combinations.
In 78.2% of cases, stents were used in conjunction with their specific, corresponding U.S. Food and Drug Administration-approved EPD. The Acculink/Accunet (n =2,617, 21.6%), Xact/Emboshield (n = 3,507, 28.9%), and Precise/Angioguard (n = 2,696, 22.2%) stent/EPD combinations were used in 72.7% of all cases. The Protégé/SpiderFx (ev3 Endovascular Inc., Plymouth, Minnesota) (n = 453, 3.7%) and Wallstent/Filterwire (Boston Scientific, Natick, Massachusetts) (n = 213, 1.8%) devices were used in a minority of cases. In unadjusted analyses, the Precise/Angioguard system was associated with higher rates of the primary outcome than were the Acculink/Accunet (2.5% vs. 1.8%; p = 0.058) and Xact/Emboshield (2.5% vs. 1.9%; p = 0.14) systems that were not statistically different. In adjusted analyses, differences between Precise/Angioguard and Accunet/Acculink (odds ratio [OR]: 1.48, 95% confidence interval [CI]: 0.89 to 2.47; p = 0.065), Precise/Angioguard and Xact/Emboshield (OR: 1.16, 95% CI: 0.77 to 1.76; p = 0.38), and Xact/Emboshield and Accunet/Acculink (OR: 1.28, 95% CI: 0.82 to 1.97; p = 0.18) remained nonsignificant.
In modern U.S. practice, the Acculink/Accunet, Xact/Emboshield, and Precise/Angioguard carotid stenting systems are used in most cases and are associated with similarly low rates of adverse events.
[Show abstract][Hide abstract] ABSTRACT: Percutaneous endovascular revascularization is emerging as the first line treatment for peripheral artery disease for both intermittent claudication and chronic critical limb ischemia. Radiation doses for these interventions have not been well documented.
A single center retrospective study of therapeutic endovascular lower extremity interventions performed between September 2006 and December 2011 was undertaken. Collected data included patient demographics, procedure indication, procedural access, anatomic location of occlusive disease (pelvis, thigh, below-knee, or multilevel), and radiation exposure parameters including dose area product (DAP) and fluoroscopy time.
Data was available for 382 procedures performed in 313 patients. Eighteen procedures bilateral procedures were excluded. Access site and complete anatomic data were available for 346 procedures. DAP was significantly higher for procedures performed in the pelvis compared with thigh procedures (179.6 vs 63.2 Gy*cm(2); P < .0001) and below-knee procedures (179.6 vs 28.9 Gy*cm(2); P < .0001), despite shorter fluoroscopy times (11.8 vs 16.4 minutes; P < .0001 and 11.1 vs 31.06 minutes; P < .0001, respectively). Procedure access-site affected radiation dose as well; contralateral up-and-over access resulted in a higher DAP than antegrade access (112.2 vs 42.6 Gy*cm(2); P < .0001). In a multivariable analysis, anatomic location of the procedure showed the strongest association with radiation dose (P < .0001).
Percutaneous endovascular revascularization for lower extremity peripheral artery disease involves a substantial radiation dose, comparable, on average, to a computed tomography scan of the abdomen and pelvis. Procedures performed in the pelvis for intermittent claudication involve more radiation than thigh or below-knee procedures for chronic critical limb ischemia. Radiation dose should be considered when planning these procedures.
Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 07/2013; · 3.52 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Objectives
We developed and internally validated a risk score to predict in-hospital stroke or death after carotid artery stenting (CAS).
A tool that accurately assesses CAS risk could aid clinical decision making and improve patient selection.
Patients undergoing CAS without acute evolving stroke from April 2005 through June 2011 as part of the NCDR Carotid Artery Revascularization and Endarterectomy (CARE) Registry were included. In-hospital stroke or death was modeled using logistic regression with 35 candidate variables. Internal validation was achieved with bootstrapping, and model discrimination and calibration were assessed.
A total of 271 (2.4%) primary endpoint events occurred during 11,122 procedures. Independent predictors of stroke or death included impending major surgery, previous stroke, age, symptomatic lesion, atrial fibrillation, and absence of previous ipsilateral carotid endarterectomy. The model was well calibrated with moderate discriminatory ability (C-statistic: 0.71) overall, and within symptomatic (C-statistic: 0.68) and asymptomatic (C-statistic: 0.72) subgroups. The inclusion of available angiographic variables did not improve model performance (C-statistic: 0.72, integrated discrimination improvement 0.001; p = 0.21). The NCDR CAS score was developed to support prospective risk quantification.
The NCDR CAS score, comprising 6 clinical variables, predicts in-hospital S/D after CAS. This tool may be useful to assist clinicians in evaluating optimal management, share more accurate pre-procedural risks with patients, and improve patient selection for CAS.
Journal of the American College of Cardiology 10/2012; 60(17):1617–1622. · 14.09 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To describe the clinical and procedural outcomes of patients treated with the valve-in-valve technique for severe aortic insufficiency (AI) after balloon-expandable transcatheter aortic valve replacement (TAVR).
Severe AI immediately after valve implantation is a notable complication of TAVR. It can be treated with a valve-in-valve technique which involves deploying a second valve within the first one to crush the leaflets of the first implant leaving a new functional valve.
We analyzed data on 142 consecutive patients at our institution undergoing TAVR with the Sapien valve between November of 2007 and April of 2011. Etiologies of acute AI, procedural and intermediate term clinical outcomes were reported for those in whom a valve-in-valve procedure was necessary. Post-hoc analysis of these cases with C-THV imaging (Paieon Medical Ltd.) was performed to elucidate the mechanism for successful AI treatment.
A total of 5 of 142 (3.5%) patients were treated with the valve-in-valve technique. Etiologies of the aortic valve insufficiency included bioprosthesis malposition (n = 3), valve dysfunction (n = 1), and valve undersizing (n = 1). With placement of the second valve, the first valve dimensions increased to approach the nominal valve size while the second valve size remained less than nominal.
The valve-in-valve technique is an appropriate bailout measure for patients with acute valvular AI after balloon-expandable TAVR.
Catheterization and Cardiovascular Interventions 03/2012; 80(1):139-47. · 2.51 Impact Factor