David J Cohen

University of Missouri - Kansas City, Kansas City, Missouri, United States

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Publications (287)2181.12 Total impact

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    ABSTRACT: -Many clinical trials use composite endpoints to reduce sample size, but the relative importance of each individual endpoint within the composite may differ between patients and researchers.
    Circulation 09/2014; · 15.20 Impact Factor
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    ABSTRACT: The aim of this study was to identify clinical, procedural, and angiographic correlates of late/very late drug-eluting stent (DES) thrombosis as well as to determine the clinical outcomes of these events.
    JACC. Cardiovascular interventions. 09/2014;
  • Suzanne J Baron, Robert W Yeh, David J Cohen
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    ABSTRACT: Over the past several decades, major changes in lifestyle, preventive care, and clinical management have contributed to an impressive reduction in coronary artery disease (CAD) prevalence, incident acute myocardial infarction (AMI), and deaths due to coronary heart disease(1-3). As a result, use of cardiovascular services in the United States has decreased dramatically in recent years. For patients with CAD, advances in medical management have allowed more and more patients to avoid elective catheterization procedures, while the results of recent studies (e.g. COURAGE(4), FAME(5), and SYNTAX(6)) have led to more judicious use of PCI in patients with chronic CAD. The combined effect of these trends has been a marked reduction in overall PCI volumes(7), from a peak of nearly 1 million in the US in 2006 to approximately 600,000 in recent years(8). At the same time as overall PCI volumes have been decreasing, the number of PCI centers has been increasing as data have emerged indicating that the absence of on-site cardiac surgery does not adversely impact patient outcomes after either emergent or elective PCI(9, 10). Together, declining PCI volumes and the increasing number of PCI centers has led to a decrease in volume of PCI procedures at both the center and operator level(11).
    Circulation 09/2014; · 15.20 Impact Factor
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    ABSTRACT: In high-risk or inoperable patients with severe symptomatic aortic stenosis, transcatheter aortic valve implantation (TAVI) is a proven alternative to standard (i.e., medical) therapy or surgical aortic valve replacement. Concerns have been raised, however, about patients who survive the procedure but have short subsequent survival. The aim of this study was therefore to identify correlates of early out-of-hospital mortality (EOHM) in patients who underwent successful TAVI, rendering TAVI potentially "futile." Patients who were discharged from the hospital and survived >30 days but <12 months after TAVI were identified (the EOHM group). Independent predictors of EOHM were explored, including patient-level factors and procedural nonfatal major complications (NFMCs). A sensitivity analysis was also performed, excluding patients with NFMCs. Among 485 patients who were discharged from the hospital and survived 30 days after TAVI, 101 (21%) were dead within 1 year. Independent predictors of EOHM included serum creatinine, liver disease, coagulopathy, mental status, body mass index, male gender, and Society of Thoracic Surgeons score. Although NFMCs were strongly associated with EOHM, patient-level risk factors for EOHM were similar between patients who did and those who did not experience NFMCs. Compared with standard therapy, TAVI patients with EOHM had similar 6-month 6-minute walk distances and functional classes, with higher rates of repeat hospitalization. In conclusion, in high-risk or inoperable patients who underwent TAVI and were discharged and alive at 30 days, EOHM was not infrequent and was determined largely by presenting characteristics and the occurrence of periprocedural NFMCs. Careful screening and minimization of NFMCs may maximize the benefit of TAVI.
    The American Journal of Cardiology 08/2014; · 3.21 Impact Factor
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    ABSTRACT: -The SYNTAX trial demonstrated that in patients with 3-vessel or left-main CAD, CABG was associated with a lower rate of cardiovascular death, MI, stroke, or repeat revascularization compared with DES-PCI. The long-term cost-effectiveness of these strategies is unknown.
    Circulation 08/2014; · 15.20 Impact Factor
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    ABSTRACT: Objectives CHARISMA was a landmark randomized clinical trial that failed to demonstrate a benefit of dual antiplatelet therapy (DAPT) over aspirin alone for preventing cardiovascular events. However, subgroup analyses of the trial found fewer major adverse cardiovascular events (MACEs) for patients with established cardiovascular disease but more MACEs for patients with multiple risk factors without established cardiovascular disease. Our objective was to examine DAPT use in contemporary clinical practice after publication of CHARISMA results. Study Design Retrospective analysis of a large clinical registry of outpatient cardiovascular visits to over 1000 physicians that collected data on patient clinical history, symptoms, vital signs, and medications. Methods Clinical characteristics and prescription rates of aspirin and clopidogrel were compared for patients with established cardiovascular disease and for patients with only multiple cardiovascular risk factors. Prescription of DAPT by calendar quarter was evaluated from 2008 to 2011 using multivariable Poisson regression models. Results Of 167,839 patients with established cardiovascular disease, 20.5% were prescribed both aspirin and clopidogrel. Of 20,478 patients with multiple risk factors but no known cardiovascular disease, 3.5% were prescribed both aspirin and clopidogrel. Across 14 calendar quarters, prescription rates of DAPT did not change significantly for patients with established CVD but decreased for patients with multiple risk factors with an incidence rate ratio of 0.77. Conclusions Use of DAPT is modest in patients with established cardiovascular disease, for whom the CHARISMA trial suggested decreased MACEs, and prescription rates have remained stable over time. Use of DAPT in patients with multiple risk factors only, for whom CHARISMA suggested that DAPT may lead to increased MACE, was low and decreased over time.
    The American journal of managed care. 08/2014; 20(8):659-665.
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    ABSTRACT: The use of bivalirudin versus unfractionated heparin monotherapy in patients without ST-segment-elevation myocardial infarction is not well defined. The study population consisted of patients enrolled in the Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) registry with either non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease, who underwent percutaneous coronary intervention with either unfractionated heparin or bivalirudin monotherapy. Propensity score matching was used to adjust for baseline characteristics. The primary bleeding (in-hospital composite bleeding-access site bleeding, thrombolysis in myocardial infarction major/minor bleeding, or transfusion) and primary (in-hospital death/myocardial infarction) and secondary ischemic outcomes (death/myocardial infarction/unplanned repeat revascularization at 12 months) were evaluated. Propensity score matching yielded 1036 patients with non-ST-segment-elevation acute coronary syndromes and 2062 patients with stable ischemic heart disease. For the non-ST-segment-elevation acute coronary syndrome cohort, bivalirudin use was associated with lower bleeding (difference, -3.3% [-0.8% to -5.8%]; P=0.01; number need to treat=30) without increase in either primary (difference, 1.2% [4.1% to -1.8%]; P=0.45) or secondary ischemic outcomes, including stent thrombosis (difference, 0.0% [1.3% to -1.3%]; P=1.00). Similarly, in the stable ischemic heart disease cohort, bivalirudin use was associated with lower bleeding (difference, -1.8% [-0.4% to -3.3%]; P=0.01; number need to treat=53) without increase in either primary (difference, 0.4% [2.3% to -1.5%]; P=0.70) or secondary ischemic outcomes, including stent thrombosis (difference, 0.0% [0.7% to -0.7%]; P=1.00) when compared with unfractionated heparin monotherapy. Among patients with non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease undergoing percutaneous coronary intervention, bivalirudin use during percutaneous coronary intervention when compared with unfractionated heparin monotherapy was associated with lower bleeding without significant increase in ischemic outcomes or stent thrombosis.
    Circulation Cardiovascular Interventions 04/2014; · 6.54 Impact Factor
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    ABSTRACT: Allograft outcomes in patients undergoing repeat renal transplantation are inferior compared to first-time transplant recipient outcomes. Donor-specific antibodies detected by solid-phase assays (DSA-SPA) may contribute to the worse prognosis. The influence of DSA-SPA on repeat renal transplantation outcomes has not been previously studied in detail. This study reports the findings in 174 patients who underwent repeat renal transplantation between years 2007 and 2012. These included 62 patients with preformed DSA-SPA detected by Luminex at the time of transplantation. Patients received standard and consistent immunosuppression and were monitored closely for evidence of rejection. Recipients who underwent desensitization were excluded from this analysis. Endpoints included development of biopsy-proven acute rejection and analysis of graft survival and function. Patients in the DSA-SPA-positive and DSA-SPA-negative groups received similar immunosuppression, and a similar proportion of recipients had a peak panel reactive antibody greater than 20%; the two groups differed with respect to human leukocyte antigen mismatches (4.7±1.1 vs. 4.1±1.7, P=0.024). Recipients with preformed DSA-SPA had higher rejection rates (54.8% vs. 34.8%, P=0.01), including higher rates of antibody-mediated rejection (AMR) (32.3% vs. 7.1%, P<0.001). Recipients who were DSA-SPA-positive and flow cytometry crossmatch (FCXM)-positive had a higher incidence of both AMR (OR 4.6, P=0.009) and of acute rejection (OR 3.57, P=0.02) as compared to those who were DSA-SPA-positive and FCXM-negative. Overall allograft survival was similar in the DSA-SPA-positive and DSA-SPA-negative groups (log-rank test=0.63, P=0.428). Differences in allograft function were detectable after 2 years (32.8±13.1 vs. 47±20.2 mL/min/1.73 m, P=0.023) and may be reflective of more AMR among DSA-SPA-positive patients. This analysis suggests that DSA-SPA increases the overall risk of acute rejection but does not appear to adversely impact allograft survival during the early follow-up period. Close monitoring of renal function and early biopsy for AMR detection appear to allow for satisfactory short-term allograft outcomes in repeat transplant recipients.
    Transplantation 03/2014; 97(6):642-7. · 3.78 Impact Factor
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    ABSTRACT: The use of early corticosteroid withdrawal (ECSW) protocols after kidney transplantation has become common, but the effects on fracture risk and bone quality are unclear. We enrolled 47 first-time adult transplant recipients managed with ECSW into a 1-year study to evaluate changes in bone mass, microarchitecture, biomechanical competence, and remodeling with dual energy x-ray absorptiometry (DXA), high-resolution peripheral quantitative computed tomography (HRpQCT), parathyroid hormone (PTH) levels, and bone turnover markers obtained at baseline and 3, 6, and 12 months post-transplantation. Compared with baseline, 12-month areal bone mineral density by DXA did not change significantly at the spine and hip, but it declined significantly at the 1/3 and ultradistal radii (2.2% and 2.9%, respectively; both P<0.001). HRpQCT of the distal radius revealed declines in cortical area, density, and thickness (3.9%, 2.1%, and 3.1%, respectively; all P<0.001), trabecular density (4.4%; P<0.001), and stiffness and failure load (3.1% and 3.5%, respectively; both P<0.05). Findings were similar at the tibia. Increasing severity of hyperparathyroidism was associated with increased cortical losses. However, loss of trabecular bone and bone strength were most severe at the lowest and highest PTH levels. In summary, ECSW was associated with preservation of bone mineral density at the central skeleton; however, it was also associated with progressive declines in cortical and trabecular bone density at the peripheral skeleton. Cortical decreases related directly to PTH levels, whereas the relationship between PTH and trabecular bone decreases was bimodal. Studies are needed to determine whether pharmacologic agents that suppress PTH will prevent cortical and trabecular losses and post-transplant fractures.
    Journal of the American Society of Nephrology 02/2014; · 8.99 Impact Factor
  • Journal of the American College of Cardiology 01/2014; · 14.09 Impact Factor
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    ABSTRACT: Objective To examine sex-specific differences in outcomes following surgical (SAVR) or transcatheter aortic valve replacement (TAVR) in high-risk patients with severe aortic stenosis. Background The Placement of Aortic Transcatheter Valves (PARTNER) trial demonstrated similar two-year survival with SAVR or TAVR in high risk patients, but sex-specific outcomes are unknown. Methods 699 patients (300 female) were randomized 1:1 to either SAVR or TAVR with a balloon expandable pericardial tissue valve. Baseline characteristics and two-year outcomes of TAVR vs. SAVR were compared among males and females. Results Baseline characteristics differed between the sexes. Despite higher STS mortality risk scores (11.9 vs. 11.6, p=0.05), females had lower prevalence of coronary artery disease (64.4 % vs. 83.7%), prior CABG (19.8% vs. 61.2%), peripheral vascular disease (36.4% vs. 46.9%), diabetes (35.6% vs. 45.6%) and elevated creatinine (11.7% vs. 23.9%). Among females, procedural mortality trended lower with TAVR vs. SAVR (6.8% vs. 13.1%, p=0.07) and was maintained throughout follow-up (HR = 0.67 [95% CI: 0.44, 1.00], p=0.049), driven by the transfemoral arm (HR = 0.55 [0.32, 0.93], p=0.02). Among males, although procedural mortality was lower with TAVR (6.0% vs. 12.1%, p=0.03), there was no overall survival benefit (HR = 1.15 [0.82, 1.61], p=0.42). Conclusions In this retrospective sub-analysis of high-risk, symptomatic aortic stenosis patients in the PARTNER trial, females had lower late mortality with TAVR vs. SAVR. This was especially true among patients suitable for transfemoral access and suggests that TAVR may be preferred over surgery in high-risk female patients. A randomized, controlled trial conducted specifically in females is necessary to properly study differences in mortality between treatment modalities. Clinical trial info NCT00530894
    Journal of the American College of Cardiology 01/2014; · 14.09 Impact Factor
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    ABSTRACT: Background Randomized clinical trials (RCTs) suggest benefits for the transradial approach to percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). However, transradial PCI may delay reperfusion, leading to its avoidance. We sought to quantify the delay in reperfusion from transradial PCI (“transradial delay”) that would need to be introduced to offset the potential mortality benefit of transradial PCI, compared with transfemoral, observed in RCTs. Methods We developed a decision-analytic model to compare transfemoral and transradial PCI in STEMI. 30-day mortality rates were estimated by pooling STEMI patients from two RCTs comparing transfemoral and transradial PCI. We projected the impact of transradial delay using estimates of the increase in mortality associated with door-to-balloon time delays. Sensitivity analyses were performed to understand the impact of uncertainty in assumptions. Results In the base case, a transradial delay of 83.0 minutes was needed to offset the mortality benefit of transradial PCI. When the mortality benefit of transradial PCI was one-quarter that observed in RCTs, the delay associated with equivalent mortality was 20.9 minutes. In probabilistic sensitivity analyses, transradial PCI was preferred over transfemoral PCI in 97.5% of simulations when transradial delay was 30 minutes and 79.0% of simulations when delay was 60 minutes. Conclusions A substantial transradial delay is required to eliminate even a fraction of the mortality benefit observed with transradial PCI in RCTs. Results were robust to changing multiple assumptions and have implications for operators reluctant to transition to transradial PCI in STEMI due to concern for delaying reperfusion.
    American Heart Journal. 01/2014;
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    ABSTRACT: In randomized clinical trials, procedural myocardial infarction (MI) or spontaneous MI is often weighted equally as a component of a composite clinical end point. An underlying assumption of this approach is that procedural and spontaneous MIs have similar prognostic impact. Our aim was to evaluate the prognostic impact of procedural vs spontaneous MI in patients undergoing percutaneous coronary intervention (PCI). We used data from the EVENT registry to examine the relative prognostic impact of procedural vs spontaneous MI. For the purposes of this study, patients undergoing initial PCI were stratified into 3 groups-no MI, procedural MI, or spontaneous MI-based on standard definitions applied at the time of the index procedure and followed for 1 year for outcomes of all-cause mortality and cardiovascular mortality. Multiple propensity score adjustment analysis was used to adjust for differences in baseline covariates among the 3 groups. Among 7,380 patients included in this analysis, 4,568 (62%) patients had no MI, 580 (8%) patients had procedural MI at the time of their index procedure, and 2,232 (30%) patients presented with a spontaneous MI before PCI. In unadjusted analyses, there was a graded increase in risk of 1-year mortality (1.9% vs 3.1% vs 3.9%; P < .0001) and cardiovascular death (0.5% vs 1.0% vs 1.7%; P < .0001) across the 3 groups. After adjusting for propensity scores, spontaneous MI (adjusted hazard ratio [HR] 1.62, 95% CI 1.11-2.37, P = .01) but not procedural MI (adjusted HR 1.51, 95% CI 0.89-2.54, P = .12) was independently associated with death at 12 months when compared with the no-MI group. Findings were similar when the analysis was limited to cardiovascular death (adjusted HRs 3.14 [95% CI 1.68-5.90, P < .001] and 1.74 [95% CI 0.69-4.40, P = .24], respectively). Among patients undergoing PCI, spontaneous but not procedural MI was independently associated with death and cardiovascular death at 1 year. These finding suggest that the prognostic impact of procedural MI may be less than that of spontaneous MI and should be considered in designing end points for future studies of coronary revascularization.
    American heart journal 12/2013; 166(6):1027-1034. · 4.65 Impact Factor
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    ABSTRACT: Secondary prevention trials have demonstrated the efficacy of statins in reducing cardiovascular morbidity and mortality in patients with coronary artery disease and events after percutaneous coronary intervention (PCI). However, there are few data describing the clinical value of statins in patients with coronary artery disease and chronic kidney disease (CKD) undergoing PCI. Of 10,148 patients who entered into Evaluation of Drug Eluting Stents and Ischemic Events, a multicenter registry of unselected patients undergoing PCI from July 2004 to December 2007, we studied 2,306 patients with CKD (estimated glomerular filtration rate ≤60 ml/min based on the Modified Diet in Renal Disease calculation). Patients were stratified into those receiving statins at discharge (n = 1,833, 79%) or not (n = 473, 21%). Patients in the statin group had a greater prevalence of hypertension, recent myocardial infarction (MI), and use of β blockers and angiotensin-converting enzyme inhibitors. Outcomes were assessed from discharge through 1-year follow-up. One-year all-cause mortality was 5.7% in statin group versus 8.7% in the no statin group (adjusted hazard ratio 0.55, 95% confidence interval 0.34 to 0.88). The composite of death, MI, and repeat revascularization was lower in statin group (adjusted hazard ratio 0.71, 95% confidence interval 0.51 to 0.99). In conclusion, among patients with CKD undergoing PCI, the prescription of statins at hospital discharge was associated with a significant improvement in subsequent outcomes including mortality and composite end point of death, MI, and repeat revascularization.
    The American journal of cardiology 11/2013; · 3.58 Impact Factor
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    ABSTRACT: Background Atherosclerotic renal-artery stenosis is a common problem in the elderly. Despite two randomized trials that did not show a benefit of renal-artery stenting with respect to kidney function, the usefulness of stenting for the prevention of major adverse renal and cardiovascular events is uncertain. Methods We randomly assigned 947 participants who had atherosclerotic renal-artery stenosis and either systolic hypertension while taking two or more antihypertensive drugs or chronic kidney disease to medical therapy plus renal-artery stenting or medical therapy alone. Participants were followed for the occurrence of adverse cardiovascular and renal events (a composite end point of death from cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy). Results Over a median follow-up period of 43 months (interquartile range, 31 to 55), the rate of the primary composite end point did not differ significantly between participants who underwent stenting in addition to receiving medical therapy and those who received medical therapy alone (35.1% and 35.8%, respectively; hazard ratio with stenting, 0.94; 95% confidence interval [CI], 0.76 to 1.17; P=0.58). There were also no significant differences between the treatment groups in the rates of the individual components of the primary end point or in all-cause mortality. During follow-up, there was a consistent modest difference in systolic blood pressure favoring the stent group (-2.3 mm Hg; 95% CI, -4.4 to -0.2; P=0.03). Conclusions Renal-artery stenting did not confer a significant benefit with respect to the prevention of clinical events when added to comprehensive, multifactorial medical therapy in people with atherosclerotic renal-artery stenosis and hypertension or chronic kidney disease. (Funded by the National Heart, Lung and Blood Institute and others; ClinicalTrials.gov number, NCT00081731 .).
    New England Journal of Medicine 11/2013; · 54.42 Impact Factor
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    ABSTRACT: IMPORTANCE The FREEDOM trial demonstrated that among patients with diabetes mellitus and multivessel coronary artery disease, coronary artery bypass graft (CABG) surgery resulted in lower rates of death and myocardial infarction but a higher risk of stroke when compared with percutaneous coronary intervention (PCI) using drug-eluting stents. Whether there are treatment differences in health status, as assessed from the patient's perspective, is unknown. OBJECTIVES To compare the relative effects of CABG vs PCI using drug-eluting stents on health status among patients with diabetes mellitus and multivessel coronary artery disease. DESIGN, SETTING, AND PARTICIPANTS Between 2005 and 2010, 1900 patients from 18 countries with diabetes mellitus and multivessel coronary artery disease were randomized to undergo either CABG surgery (n = 947) or PCI (n = 953) as an initial treatment strategy. Of these, a total of 1880 patients had baseline health status assessed (935 CABG, 945 PCI) and comprised the primary analytic sample. INTERVENTIONS Initial revascularization with CABG surgery or PCI. MAIN OUTCOMES AND MEASURES Health status was assessed using the angina frequency, physical limitations, and quality-of-life domains of the Seattle Angina Questionnaire at baseline, at 1, 6, and 12 months, and annually thereafter. For each scale, scores range from 0 to 100 with higher scores representing better health. The effect of CABG surgery vs PCI was evaluated using longitudinal mixed-effect models. RESULTS At baseline, mean (SD) scores for the angina frequency, physical limitations, and quality-of-life subscales of the Seattle Angina Questionnaire were 70.9 (25.1), 67.3 (24.4), and 47.8 (25.0) for the CABG group and 71.4 (24.7), 69.9 (23.2), and 49.2 (25.7) for the PCI group, respectively. At 2-year follow-up, mean (SD) scores were 96.0 (11.9), 87.8 (18.7), and 82.2 (18.9) after CABG and 94.7 (14.3), 86.0 (19.3), and 80.4 (19.6) after PCI, with significantly greater benefit of CABG on each domain (mean treatment benefit, 1.3 [95% CI, 0.3-2.2], 4.4 [95% CI, 2.7-6.1], and 2.2 [95% CI, 0.7-3.8] points, respectively; P < .01 for each comparison). Beyond 2 years, the 2 revascularization strategies provided generally similar patient-reported outcomes. CONCLUSIONS AND RELEVANCE For patients with diabetes and multivessel CAD, CABG surgery provided slightly better intermediate-term health status and quality of life than PCI using drug-eluting stents. The magnitude of benefit was small, without consistent differences beyond 2 years, in part due to the higher rate of repeat revascularization with PCI. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00086450.
    JAMA The Journal of the American Medical Association 10/2013; 310(15):1581-1590. · 29.98 Impact Factor
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    ABSTRACT: To examine the impact of reasons for surgical inoperability on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). Patients with severe aortic stenosis (AS) may be deemed inoperable due to either technical or clinical reasons. The relative impact of each designation on early and late outcomes after TAVR is unclear. Patients were studied from the inoperable arm (cohort B) of the randomized PARTNER (Placement of AoRTic TraNscathetER Valve) trial and the non-randomized continued access registry. Patients were classified according to whether or not they were technically inoperable (TI) or clinically inoperable (CLI). Reasons for TI included porcelain aorta, previous mediastinal radiation, chest wall deformity and potential for injury to previous bypass graft on sternal reentry. Reasons for CLI were systemic factors that were deemed to make survival unlikely. Of the 369 patients, 23% were considered inoperable for technical reasons alone, the remaining were judged to be CLI. For TI, the commonest cause was a porcelain aorta (42%) and for CLI it was multiple comorbidities (48%) and frailty (31%). Quality of life (QOL) and 2-year mortality were significantly lower among TI patients compared with CLI patients (mortality 23.3% vs. 43.8%, p<0.001). Nonetheless, TAVR led to substantial survival benefits compared with standard therapy in both inoperable cohorts. Patients undergoing TAVR based solely on TI have better survival and QOL improvements than those who are inoperable due to clinical comorbidities. Both TI and CLI TAVR have significant survival benefit in the context of standard therapy. Clinical trial info: Substudy of the PARTNER trial NCT00530894.
    Journal of the American College of Cardiology 10/2013; · 14.09 Impact Factor
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    ABSTRACT: Despite increasing complexity of contemporary procedures at tertiary care hospitals, the relationship between interventional cardiology fellows-in-training (ICFITs) and complications of percutaneous coronary intervention (PCI) has not been reported. We compiled logbooks of 6 ICFITs at an academic hospital and evaluated patient and procedural characteristics of PCIs performed with and without presence of an ICFIT. The primary end point was the composite of all in-hospital PCI complications defined by the American College of Cardiology's National Cardiovascular Data Registry: (1) catheterization laboratory events such as no-reflow and dissection/perforation, (2) general clinical events such as stroke or cardiogenic shock, (3) vascular and bleeding complications, and (4) miscellaneous complications such as peak troponin or creatinine levels. Logistic regression adjusted for differences in measured confounders between patients treated with and without presence of an ICFIT. All analyses were repeated after excluding PCI for ST-elevation myocardial infarction. Of 2,605 PCI procedures at the academic hospital between July 2007 and April 2010, an ICFIT was present for 1,638 procedures (63%). Despite having worse clinical and procedural characteristics, patients in the ICFIT group experienced similar rates of the composite end point (12.9% vs 14.5% without ICFIT, p = 0.27). Longer mean fluoroscopy times and greater number of stents were noted in the ICFIT group; however, hospital length of stay was shorter and no individual adverse events were increased in the ICFIT procedures. Presence of an ICFIT remained unrelated to the composite end point after multivariable adjustment (odds ratio 0.92, 95% confidence interval 0.71 to 1.20; p = 0.53), and findings were similar after excluding PCI for ST-elevation myocardial infarction. In conclusion, in contemporary practice at a large academic medical center, PCI complication rates were not adversely affected by the presence of an ICFIT.
    The American journal of cardiology 10/2013; · 3.58 Impact Factor
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    ABSTRACT: The unsustainable trend of rising healthcare costs necessitates difficult allocation decisions by governments, policymakers, and physicians. Consequently, recent advances in transcatheter valve therapies require not only clinical evaluation, but also careful economic evaluation. Under current indications, each year there are nearly 18,000 new candidates for transcatheter aortic valve implantation (TAVI) in European countries and an additional 9,200 in North America, with an estimated cost of more than $2 billion per year. Nonetheless, when compared with standard medical therapy for severe aortic stenosis (AS), TAVI leads to gains in life expectancy at an incremental cost that is acceptable by most Western standards. On the other hand, for high-risk (but operable) patients with severe AS, TAVI provides no proven survival advantage and only a transient quality of life benefit compared with surgical aortic valve replacement (SAVR). Thus, for these patients, the cost-effectiveness of TAVI compared with SAVR hinges on the magnitude and duration of the quality of life benefit as well as the relative cost of both procedures. Current data suggest that, for patients who are eligible for transfemoral access, TAVI is economically attractive (or even economically dominant) compared with high-risk SAVR. However, the cost-effectiveness of TAVI for patients who are not suitable for a transfemoral approach appears to be less favourable. Transcatheter mitral valve repair is in an earlier stage of clinical implementation than TAVI. As the evidence for this procedure accumulates, more formal economic analysis should be feasible.
    EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 09/2013; 9 Suppl:S48-54. · 3.17 Impact Factor
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    ABSTRACT: Background-Transcatheter aortic valve replacement (TAVR) has emerged as a less invasive option for valve replacement of patients with severe aortic stenosis. Although it has been recommended that TAVR should not be offered to patients who will not improve functionally or derive meaningful survival benefit from the procedure, no guidance exists on how best to identify such patients. The first step in this process is to define a poor outcome that can then be used as a foundation for subsequent case identification. We sought to evaluate potential definitions of a poor outcome after TAVR that combine both mortality and quality of life components.Methods and Results-Using data from 463 patients who underwent TAVR as part of the Placement of AoRTic TraNscathetER Valve (PARTNER) trial, we evaluated 6-month mortality and quality of life outcomes using the Kansas City Cardiomyopathy Questionnaire to explore potential definitions of a poor outcome. We then compared the strengths and weaknesses of each potential definition by examining the relationship between baseline and 6-month Kansas City Cardiomyopathy Questionnaire scores for each patient. Based on these analyses, we argue that the most appropriate definition of a poor outcome after TAVR is (1) death, (2) Kansas City Cardiomyopathy Questionnaire overall summary score <45, or (3) Kansas City Cardiomyopathy Questionnaire decrease of ≥10 points, which best reflects a failure to achieve the therapeutic goals of TAVR.Conclusions-Using empirical data on a large number of patients enrolled in the PARTNER trial, we propose a definition for poor outcome after TAVR that combines both mortality and quality of life measures into a single composite end point. Use of this end point (or other similar end points) in future studies can facilitate development of predictive models that may be useful to identify patients who are poor candidates for TAVR and to provide such patients and their families with appropriate expectations of functional recovery after TAVR.
    Circulation Cardiovascular Quality and Outcomes 09/2013; · 5.66 Impact Factor

Publication Stats

9k Citations
2,181.12 Total Impact Points

Institutions

  • 2008–2014
    • University of Missouri - Kansas City
      • "Saint Luke's" Mid America Heart Institute
      Kansas City, Missouri, United States
    • Lifespan
      Providence, Rhode Island, United States
    • Icahn School of Medicine at Mount Sinai
      Manhattan, New York, United States
    • St. Luke School of Medicine
      Kansas City, Missouri, United States
    • Stony Brook University
      • Division of Cardiovascular Medicine
      Stony Brook, NY, United States
    • Mayo Foundation for Medical Education and Research
      Rochester, Michigan, United States
  • 2006–2014
    • Saint Luke's Health System (KS, USA)
      Kansas City, Kansas, United States
    • Cleveland Clinic
      • Department of Cardiology
      Cleveland, Ohio, United States
  • 2012–2013
    • Erasmus Universiteit Rotterdam
      • Department of Cardio-Thoracic Surgery
      Rotterdam, South Holland, Netherlands
    • Washington Hospital Center
      Washington, Washington, D.C., United States
    • University of Michigan
      Ann Arbor, Michigan, United States
    • York Hospital
      York, Pennsylvania, United States
  • 2011–2013
    • Rhode Island Hospital
      Providence, Rhode Island, United States
    • Saint Louis University
      • Division of Cardiology
      Saint Louis, Michigan, United States
    • Massachusetts General Hospital
      • Division of Cardiology
      Boston, MA, United States
    • University of Alabama at Birmingham
      • Department of Epidemiology
      Birmingham, AL, United States
  • 2005–2013
    • New York Presbyterian Hospital
      New York City, New York, United States
    • Duke University Medical Center
      • Duke Clinical Research Institute
      Durham, NC, United States
    • St. Michael's Hospital
      Toronto, Ontario, Canada
    • Flinders University
      • Flinders Medical Centre
      Adelaide, South Australia, Australia
    • University of Cincinnati
      Cincinnati, Ohio, United States
    • Boston Scientific
      Boston, Massachusetts, United States
  • 2003–2013
    • CUNY Graduate Center
      New York City, New York, United States
    • Henry Ford Health System
      Detroit, Michigan, United States
  • 2002–2013
    • Harvard University
      Cambridge, Massachusetts, United States
    • Duke University
      Durham, North Carolina, United States
  • 2010–2012
    • St. Luke's Hospital (MO, USA)
      Saint Louis, Michigan, United States
    • University of British Columbia - Vancouver
      Vancouver, British Columbia, Canada
    • Loyola University Medical Center
      Maywood, Illinois, United States
  • 1999–2012
    • Beth Israel Deaconess Medical Center
      • Department of Medicine
      Boston, Massachusetts, United States
  • 2009–2011
    • Yale-New Haven Hospital
      New Haven, Connecticut, United States
    • North Carolina Clinical Research
      Raleigh, North Carolina, United States
    • Stony Brook University Hospital
      • Department of Internal Medicine
      Stony Brook, NY, United States
    • Christiana Care Health System
      Wilmington, Delaware, United States
    • Oklahoma City University
      Oklahoma City, Oklahoma, United States
  • 2006–2011
    • St. Luke's Hospital
      Cedar Rapids, Iowa, United States
  • 2005–2009
    • Columbia University
      • • College of Physicians and Surgeons
      • • Division of Nephrology
      New York City, New York, United States
  • 2007
    • Baylor College of Medicine
      Houston, Texas, United States
  • 2003–2006
    • Henry Ford Hospital
      Detroit, Michigan, United States
  • 2002–2005
    • Cardiovascular Research Foundation
      New York City, New York, United States
  • 2002–2004
    • Brigham and Women's Hospital
      • • Center for Brain Mind Medicine
      • • Division of Cardiovascular Medicine
      Boston, MA, United States