Publications (57) View all
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Article: Four-year Results of a Randomized Controlled Trial of Percutaneous Repair Versus Surgery for Mitral Regurgitation.
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ABSTRACT: OBJECTIVES: We sought to evaluate 4-year outcomes of percutaneous repair versus surgery for mitral regurgitation. BACKGROUND: Transcatheter therapies are being developed to treat valvular heart disease. In the EVEREST II Trial, treatment of mitral valve regurgitation (MR) with a novel percutaneous device was compared with surgery and showed superior safety, but less reduction in MR at one year overall. We report the four year outcomes from the EVEREST II Trial. METHODS: Patients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the MitraClip device or conventional mitral valve surgery in a 2:1 ratio (184:95). Patients were prospectively consented for five years of follow-up. RESULTS: At four years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the intention to treat population was 39.8% vs. 53.4% in the percutaneous repair group and surgical groups, respectively (p=0.070). Rates of death were 17.4% vs. 17.8% (p=0.914), and 3+ or 4+ MR was present in 21.7% vs. 24.7% (p=0.745) at 4 years of follow-up, respectively. Surgery for mitral valve dysfunction, however, occurred in 20.4% vs. 2.2% (p<0.001) at one year and 24.8% vs. 5.5% (p<0.001) at four years. CONCLUSIONS: Patients treated with percutaneous repair of the mitral valve more commonly required surgery to treat residual MR; however, after the first year of follow-up, there were few surgeries required after either percutaneous or surgical treatment and no difference in the prevalence of moderate-severe and severe MR or mortality at four years.Journal of the American College of Cardiology 05/2013; · 14.16 Impact Factor -
Article: Objective Simulator-Based Evaluation of Carotid Artery Stenting Proficiency (from Assessment of Operator Performance by the Carotid Stenting Simulator Study [ASSESS]).
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ABSTRACT: Studies have suggested that operator proficiency has a substantial effect on complication rates and procedural outcomes. Endovascular simulators have been used for training and have been proposed as an alternative to the conventional assessment of skills. The present study sought to validate simulation as an objective method for proficiency evaluation in carotid artery stenting. Interventional cardiologists classified as novice, intermediate, or experienced practitioners performed 3 simulated, interactive carotid stenting cases on an AngioMentor endovascular simulator. An automated algorithm scored the participants according to the technical performance, medical management, and angiographic results. A total of 33 interventional cardiologists (8 novices, 15 intermediates, and 10 experts) completed 82 simulated procedures. The composite scores for the case simulations varied significantly by operator experience, with better scores for the more experienced groups (p <0.0001). The metrics that discriminated between operator experience groups included fluoroscopy time, crossing the carotid lesion with devices other than a 0.014-in. wire before filter deployment, and incomplete coverage of the lesion by the stent. In conclusion, the results of the present study validate that a simulator with an automated scoring system is able to discriminate between levels of operator proficiency for carotid artery stenting. Simulator-based performance assessment could have a role in initial and ongoing proficiency evaluations and credentialing of interventional operators of high-risk endovascular procedures.The American journal of cardiology 04/2013; · 3.58 Impact Factor -
Article: Effects of atrial fibrillation on treatment of mitral regurgitation in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) randomized trial.
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ABSTRACT: The purpose of this study was to characterize patients with mitral regurgitation (MR) and atrial fibrillation (AF) treated percutaneously using the MitraClip device (Abbott Vascular, Abbott Park, Illinois) and compare the results with surgery in this population. The EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) randomized controlled trial compared a less invasive catheter-based treatment for MR with surgery, providing an opportunity to assess the impact of AF on the outcomes of both the MitraClip procedure and surgical repair. The study population included 264 patients with moderately severe or severe MR assessed by an independent echocardiographic core laboratory. Comparison of safety and effectiveness study endpoints at 30 days and 1 year were made using both intention-to-treat and per-protocol (cohort of patients with MR ≤2+ at discharge) analyses. Pre-existing AF was present in 27% of patients. These patients were older, had more advanced disease, and were more likely to have a functional etiology. Similar reduction of MR to ≤2+ before discharge was achieved in patients with AF (83%) and in patients without AF (75%, p = 0.3). Freedom from death, mitral valve surgery for valve dysfunction, and MR >2+ was similar at 12 months for AF patients (64%) and for no-AF patients (61%, p = 0.3). At 12 months, MR reduction to <2+ was greater with surgery than with MitraClip, but there was no interaction between rhythm and MR reduction, and no difference in all-cause mortality between patients with and patients without AF. Atrial fibrillation is associated with more advanced valvular disease and noncardiac comorbidities. However, acute procedural success, safety, and 1-year efficacy with MitraClip therapy is similar for patients with AF and without AF.Journal of the American College of Cardiology 04/2012; 59(14):1312-9. · 14.16 Impact Factor -
Article: Results of carotid artery stenting with distal embolic protection with improved systems: Protected Carotid Artery Stenting in Patients at High Risk for Carotid Endarterectomy (PROTECT) trial.
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ABSTRACT: The Protected Carotid Artery Stenting in Patients at High Risk for Carotid Endarterectomy (PROTECT) study was performed to evaluate the safety and effectiveness of two devices for carotid artery stenting (CAS) in the treatment of carotid artery stenosis in patients at high risk for carotid endarterectomy (CEA): (1) a new embolic protection device, the Emboshield Pro (Abbott Vascular, Abbott Park, Ill), using the periprocedural composite end point of 30-day death, stroke, and myocardial infarction (DSMI), and (2) a carotid stent in conjunction with an embolic protection device (EPD) using the DSMI periprocedural composite end point plus ipsilateral stroke at up to 3 years for long-term evaluation. This prospective, multicenter clinical trial enrolled 220 consecutive participants between November 29, 2006, and January 14, 2008, followed by a second cohort of 102 participants between January 14 and June 18, 2008. Enrolled participants had carotid stenosis (symptomatic >50% or asymptomatic >80%). The first 220 subjects underwent distal EPD placement with a new large-diameter filter, and the second cohort of 102 underwent placement of an older EPD that is no longer manufactured. All 322 participants were to be treated with a dedicated carotid stent with a tapered, small, closed-cell design (Xact; Abbott Vascular) and were to be included in the long-term evaluation. Independent neurologic assessment was performed before CAS and at 1 day, 30 days, and annually after CAS. All primary end point events were independently adjudicated by a central committee. The periprocedural composite end point of DSMI (95% confidence interval) in the first 220 participants was 2.3% (0.74%, 5.22%), with a combined death and stroke rate of 1.8% (0.50%, 4.59%) and a rate of death and major stroke of 0.5% (0.01%, 2.51%). As of January 3, 2011, the median follow-up for the entire 322-subject cohort for the long-term evaluation was 2.8 years. Freedom from the periprocedural composite of DSMI plus ipsilateral stroke thereafter was 95.4%, with an annualized ipsilateral stroke rate of 0.4%. CAS outcomes in patients at high risk for CEA have improved from earlier carotid stent trials. With periprocedural rates of DSMI of 2.3%, death or stroke at 1.8%, and death or major stroke rate of 0.5%, PROTECT has the lowest rate of periprocedural complications among other comparable single-arm CAS trials in patients at high risk for CEA.Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 01/2012; 55(4):968-976.e5. · 3.52 Impact Factor -
Article: CAPTURE 2 risk-adjusted stroke outcome benchmarks for carotid artery stenting with distal embolic protection.
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ABSTRACT: Many medical procedures undergo rapid evolution and process of care improvements after introduction. National outcome standards are useful to help physicians, institutions, and other stakeholders evaluate the quality of their programs and take action when suboptimal outcomes are identified. The purpose of this analysis was to derive contemporary risk-adjusted stroke rates from a large, contemporary, independently assessed outcome database within 30 days after carotid artery stenting (CAS) in the United States. The second phase of carotid ACCULINK/ACCUNET post approval trial to uncover rare events (CAPTURE 2) is an ongoing prospective, multicenter, clinical trial conducted to assess CAS outcomes in the general practice setting after device approval for high surgical risk patients (symptomatic with >50% stenosis or asymptomatic with >80% stenosis). A neurologist examined the patients before the procedure, at 1 day and 30 days after CAS. The primary endpoint was a composite of death, any stroke, or myocardial infarction (MI) within the periprocedural period. Strokes and neurologic events suspected to be strokes were adjudicated by an independent clinical events adjudication committee. Logistic regression analysis including stepwise logistic and multivariable modeling was performed to determine clinical predictors of periprocedural stroke outcome and generate a parsimonious model that could be used for a clinical standard. Five thousand two hundred ninety-seven consecutive patients (5297) had CAS performed by 459 physicians at 186 sites before the data cutoff of January 10, 2009. The 30-day rate of stroke was 2.7% (95% confidence interval [CI], 2.3-3.2). Multivariable predictors of periprocedural stroke included age, symptomatic status, and dwell time of embolic protection device. A parsimonious model P(i) = 1/(1+e (-(-3.83 + 0.51 x (symptomatic) + 0.31 x (age >or=80) + 0.62 x (age >or=80 x symptomatic))), including symptomatic and octogenarian status and the term of the interaction of the two, was established based on consideration of clinical predictors, clinical interaction, and practicability. CAS outcomes in patients at high surgical risk have comparable periprocedural outcomes to published randomized trials of endarterectomy for patients at standard surgical risk. A model is presented for calculating a contemporary national standard for risk-adjusted stroke rates. Quality improvement measures could be based on relative performance to this benchmark and could improve overall outcomes for patients undergoing CAS.Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 09/2010; 52(3):576-83, 583.e1-583.e2. · 3.52 Impact Factor
