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21 result(s) for "Holper, Elizabeth"
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Five-Year Follow-Up of Patients Treated for Coronary Artery Disease in the Face of an Increasing Burden of Co-Morbidity and Disease Complexity (from the NHLBI Dynamic Registry)
Management of coronary artery disease (CAD) has evolved over the past decade, but there are few prospective studies evaluating long-term outcomes in a real-world setting of evolving technical approaches and secondary prevention. The aim of this study was to determine how the mortality and morbidity of CAD has changed in patients who have undergone percutaneous coronary intervention (PCI), in the setting of co-morbidities and evolving management. The National Heart, Lung, and Blood Institute Dynamic Registry was a cohort study of patients undergoing PCI at various time points. Cohorts were enrolled in 1999 (cohort 2, n = 2,105), 2004 (cohort 4, n = 2,112), and 2006 (cohort 5, n = 2,176), and each was followed out to 5 years. Primary outcomes were death, myocardial infarction (MI), coronary artery bypass grafting, repeat PCI, and repeat revascularization. Secondary outcomes were PCI for new obstructive lesions at 5 years, 5-year rates of death and MI stratified by the severity of coronary artery and co-morbid disease. Over time, patients were more likely to have multiple co-morbidities and more severe CAD. Despite greater disease severity, there was no significant difference in death (16.5% vs 17.6%, adjusted hazard ratio [HR] 0.89, 95% confidence interval [CI] 0.74 to 1.08), MI (11.0% vs 10.6%, adjusted HR 0.87, 95% CI 0.70 to 1.08), or repeat PCI (20.4% vs 22.2%, adjusted HR 0.98, 95% CI 0.85 to 1.17) at 5-year follow-up, but there was a significant decrease in coronary artery bypass grafting (9.1% vs 4.3%, adjusted HR 0.44, 95% CI 0.32 to 0.59). Patients with 5 co-morbidities had a 40% to 60% death rate at 5 years. There was a modestly high rate of repeat PCI for new lesions, indicating a potential failure of secondary prevention for this population in the face of increasing co-morbidity. Overall 5-year rates of death, MI, repeat PCI, and repeat PCI for new lesions did not change significantly in the context of increased co-morbidities and complex disease.
A Comparison of Bare-Metal and Drug-Eluting Stents for Off-Label Indications
In patients in a large registry who received coronary stents for off-label indications, there was no difference in mortality or rates of myocardial infarction at 1 year between those receiving bare-metal stents and those receiving drug-eluting stents. In the group receiving drug-eluting stents, there was a reduced need for revascularization. There was no difference in mortality or rates of myocardial infarction at 1 year between those receiving bare-metal stents and those receiving drug-eluting stents. In the group receiving drug-eluting stents, there was a reduced need for revascularization. In 2003, the Food and Drug Administration (FDA) approved drug-eluting stents for the treatment of coronary artery disease. This decision was based on the results of clinical trials that compared a bare-metal stent with a drug-eluting stent in highly selected patients. 1 – 10 Because of the magnitude of the treatment effect of drug-eluting stents in suppressing the recurrence of lesions, consistent positive reports from subsequent trials of small subgroups, and firsthand experiences, physicians extended the use of drug-eluting stents to patients with clinical and anatomical features beyond those of patients in the FDA-approval trials. The use of drug-eluting stents in this . . .
Prognostic Usefulness of Acute Kidney Injury After Transcatheter Aortic Valve Replacement
Acute kidney injury (AKI) after transcatheter aortic valve replacement (TAVR) has been associated with increased postoperative morbidity and mortality. Long-term outcomes after TAVR with the Edwards SAPIEN valve in patients who develop AKI postoperatively are currently not well described. We retrospectively reviewed 384 consecutive patients undergoing TAVR at 2 institutions from August 2006 to April 2012. AKI was defined and staged according to Valve Academic Research Consortium-2 criteria. The incidence, multivariate predictors, and association of AKI with 3-year mortality were evaluated. Stage 1 AKI occurred in 24.0% of patients (92 of 384), stage 2 in 5.5% (21 of 384), and stage 3 in 8.1% (31 of 384). The overall operative mortality rate was 7.6%, with a mortality of 3.0% in patients with no kidney injury, 7.6% in stage 1, 23.8% in stage 2, and 32.3% in stage 3. The incidence of new postoperative dialysis was 3.1%. Survival at 3 years for no-AKI/stage 1/stage 2/stage 3 was 59.2 ± 3.3%, 43.4 ± 5.2%, 27.8 ± 10.0%, and 25.4 ± 7.9%, respectively. Logistic regression modeling for the combination of stage 2 or 3 AKI after surgery demonstrated that the last preoperative creatinine (for each 1 mg/dl increase, odds ratio = 3.23, 95% CI 1.83 to 5.69; p <0.001) and dye load (for each 10 ml increase, odds ratio = 1.04, 95% CI 1.01 to 1.08; p = 0.006) were significant predictors for AKI. In conclusion, AKI after TAVR is associated with increased postoperative and 3-year mortality. Significant multivariate predictors are potentially modifiable before the procedure.
Usefulness of Balloon Aortic Valvuloplasty in the Management of Patients With Aortic Stenosis
We aim to evaluate the contemporary role and outcomes of balloon aortic valvuloplasty (BAV), based on physician intent, for the management of severe aortic stenosis. This is a prospective, 2-center study of 100 consecutive high-risk patients with severe aortic stenosis who underwent BAV. Before BAV, physicians assigned intent as (1) bridge to decision (BTD); (2) therapeutic bridge to planned therapy; or (3) palliation. Patients in the BTD arm underwent clinical assessment at 30 days to determine eligibility for definitive valve therapy. All patients were followed up to 1 year, with outcomes measured including procedural complications, Kansas City Cardiomyopathy Questionnaires scores, 30-day and 1-year mortality, and definitive valve therapy. Enrolled patients had a mean age of 80.6 (±9.6) years, Society of Thoracic Surgeons predicted risk of mortality of 11.4% (±7.1%), and 91 (91.0%) patients had class III or IV New York Heart Association congestive heart failure. Intent in the 100 study patients was 76 BTD; 20 therapeutic bridge to planned therapy; and 4 palliation. Thirty-day mortality for all patients was 6 of 100 (6.0%), and 1-year mortality for all patients who received definitive valve therapy was 6 of 54 (11.1%). For patients surviving to 30 days, adjusted (by Society of Thoracic Surgeons predicted risk of mortality) Kansas City Cardiomyopathy Questionnaires scores were significantly improved from baseline for all patients and BTD patients. In conclusion, as a bridge to decision and treatment tool, BAV appears to have a valuable role in properly selecting and improving patients to undergo definitive valve replacement.
Description of a Method to Obtain Complete One-Year Follow-Up in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry
The Centers for Medicare and Medicaid Services National Coverage Determination requires centers performing transcatheter aortic valve implantation (TAVI) to report clinical outcomes up to 1 year. Many sites encounter challenges in obtaining complete 1-year follow-up. We report our process to address this challenge. A multidisciplinary process involving clinical personnel, data and quality managers, and research coordinators was initiated to collect TAVI data at baseline, 30 days, and 1 year. This process included (1) planned clinical follow-up of all patients at 30 days and 1 year; (2) query of health-care system-wide integrated data warehouse (IDW) to ascertain last date of clinical contact within the system for all patients; (3) online obituary search, cross-referencing for unique patient identifiers to determine if mortality occurred in remaining unknown patients; and (4) phone calls to remaining unknown patients or patients' families. Between January 2012 and December 2016, 744 patients underwent TAVI. All 744 patients were eligible for 30-day follow-up and 546 were eligible for 1-year follow-up. At routine clinical follow-up of 22 of 744 (3%) patients at 30 days and 180 of 546 (33%) patients at 1 year had unknown survival status. The integrated data warehouse query confirmed status-alive for an additional 1 of 22 patients at 30 days (55%) and 91 of 180 patients at 1 year (51%). Obituaries were identified for 23 of 180 additional patients at 1 year (13%). Phone contact identified the remaining unknown patients at 30 days and 1 year, resulting in 100% known survival status for patients at 30 days (744 of 744) and at 1 year (546 of 546). In conclusion, using a comprehensive approach, we were able to determine survival status in 100% of patients who underwent TAVI.
Incidence and Predictors of 30-Day Hospital Readmission Rate Following Percutaneous Coronary Intervention (from the National Heart, Lung, and Blood Institute Dynamic Registry)
Postdischarge outcomes after percutaneous coronary intervention (PCI) are important measurements of quality of care and complement in-hospital measurements. We sought to assess in-hospital and postdischarge PCI outcomes to (1) better understand the relation between acute and 30-day outcomes, (2) identify predictors of 30-day hospital readmission, and (3) determine the prognostic significance of 30-day hospital readmission. We analyzed in-hospital death and length of stay (LOS) and nonelective cardiac-related rehospitalization after discharge in 10,965 patients after PCI in the Dynamic Registry. From 1999 to 2006 in-hospital death rate and LOS decreased. Thirty-day cardiac readmission rate was 4.6%, with considerable variability over time and among hospitals. Risk of rehospitalization was greater in women and those with congestive heart failure, unstable angina, multiple lesions, and emergency PCI. Conversely, a lower risk of rehospitalization was associated with a larger number of treated lesions. Patients readmitted within 30 days had higher 1-year mortality than those free from hospital readmission. In conclusion, although in-hospital mortality and LOS after PCI have decreased over time, the observed 30-day cardiac readmission rate was highly variable and risk of readmission was more closely associated with underlying patient characteristics than procedural characteristics.
Association of chronic lung disease with treatments and outcomes patients with acute myocardial infarction
Although chronic lung disease (CLD) is common among patients with myocardial infarction (MI), little is known about the influence of CLD on patient management and outcomes following MI. Using the National Cardiovascular Data Registry's ACTION Registry-GWTG, demographics, clinical characteristics, treatments, processes of care, and in-hospital adverse events after acute MI were compared between patients with (n = 22,624) and without (n = 136,266) CLD. Multivariable adjustment was performed to determine the independent association of CLD with treatments and adverse events. CLD (17.0% of non–ST-elevation MI [NSTEMI] and 10.1% of ST-elevation MI [STEMI] patients) was associated with older age, female sex, and a greater burden of comorbidities. Among NSTEMI patients, those with CLD were less likely to undergo cardiac catheterization, percutaneous coronary intervention, and coronary artery bypass graft compared to those without; in contrast, no differences were seen in invasive therapies for STEMI patients with or without CLD. Multivariable-adjusted risk of major bleeding was significantly increased in CLD patients with NSTEMI (13.0% vs 8.1%, ORadj = 1.27, 95% CI = 1.20-1.34, P < .001) and STEMI (16.0% vs 10.5%, ORadj = 1.19, 95% CI = 1.10-1.29, P < .001). In NSTEMI, CLD was associated with a higher risk of inhospital mortality (ORadj = 1.21, 95% CI = 1.11-1.33); in STEMI no association between CLD and mortality was seen (ORadj = 1.05, 95% CI = 0.95-1.17). CLD is common among patients with MI and is independently associated with an increased risk for major bleeding. In NSTEMI, CLD is also associated with receiving less revascularization and with increased in-hospital mortality. Special attention should be given to this high-risk subgroup for the prevention and management of complications after MI.
Benefit of Long-Term Dual Anti-Platelet Therapy in Patients Treated With Drug-Eluting Stents: From the NHLBI Dynamic Registry
The optimal duration of dual-antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is an important, unanswered question. This study was designed to evaluate the association of varying durations of DAPT on clinical outcomes after DES implantation for the treatment of coronary artery disease. Using the National Heart, Lung, and Blood Institute Dynamic Registry, patients enrolled in the last 2 waves after index percutaneous coronary intervention with DES and who were event free at the time of landmark analysis were included. Landmark analysis was performed 12 and 24 months after percutaneous coronary intervention, and patients were stratified according to continued use of DAPT or not. Subjects were evaluated for rates of death, myocardial infarction, and stent thrombosis at 4 years from their index procedures. The numbers of evaluable patients were 2,157 and 1,918 for the 12- and 24-month landmarks, respectively. In both landmark analyses, there was a significantly lower 4-year rate of death or myocardial infarction in the group that continued DAPT compared to the group that did not (12 months: 10.5% vs 14.5%, p = 0.01; 24 months: 5.7% vs 8.6%, p = 0.02). Beneficial differences in the group that continued on DAPT were preserved after multivariate and propensity adjustment. There were no significant differences in definite stent thrombosis in either landmark analysis. In conclusion, at 12 and 24 months after DES implantation, continued use of DAPT was associated with lower 4-year risk for death and myocardial infarction.
Validation of a low-dose contrast 64-slice cardiac computed tomography angiography protocol for aortic valve annulus sizing
Cardiac computed tomography angiography (CCTA) is the gold standard for accurately sizing the aortic valve annulus prior to aortic valve replacement. A reduction of contrast volume administered for CCTA, without sacrificing image quality, is desirable. Signal-to-noise ratio represents final CCTA image quality. Consecutive patients referred to CCTA for aortic valve annulus sizing were retrospectively analyzed. Patients were grouped into a low-dose contrast (LDCT) group and traditional dose contrast (TDCT) group. In the LDCT group, contrast dose was <50% of the maximal allowable dose (3.7 × estimated glomerular filtration rate). Guided by a time-density curve, the contrast was administered in a two-stage infusion, and retrospectively gated images were acquired with a 64-multidetector computed tomography scanner. Out of 123 patients (age 80 ± 9 years; 46% female), 65 (52.9%) underwent LDCT and 58 (47.2%) underwent TDCT. Contrast volume was significantly lower in the LDCT group (LDCT 41.2 ± 9.8 vs TDCT 76.2 ± 14.2 mL; P < 0.001). The signal-to-noise ratio of the aortic root was 10.4 ± 4.1 for the LDCT group and 8.4 ± 3.3 for the TDCT group (P = 0.004). Aortic root dimensions could be measured in both LDCT and TDCT groups. In conclusion, LDCT with 64-slice CCTA can effectively size the aortic valve annulus to direct aortic valve replacement while offering reduced contrast exposure.
Relative spatial distributions of coronary artery bypass graft insertion and acute thrombosis: A model for protection from acute myocardial infarction
Randomized trials have demonstrated coronary artery bypass surgery (CABG) to be superior to percutaneous coronary intervention with respect to long-term mortality and morbidity from myocardial infarction within specific high-risk cohorts. The purpose of this study was to analyze the spatial distribution of coronary artery bypass graft anastomoses relative to acute thromboses in native coronary arteries. We hypothesized that insertion sites of bypass grafts are located distal to sites of acute thrombosis and consequently decrease cardiac morbidity and mortality associated with plaque rupture. We analyzed 168 patients with prior CABG and 208 patients with ST-segment elevation myocardial infarctions (STEMI) presenting to the Brigham and Women's Hospital who underwent coronary angiography. We constructed a spatial map of the coronary arterial bypass graft insertion sites and compared these locations to sites of acute thrombosis leading to STEMI. Graft insertion sites were consistently located distal to acute thrombosis sites (left anterior descending artery median graft insertion versus median thrombosis site = 72 versus 34 mm, right coronary artery 91 versus 42 mm, left circumflex artery 44 versus 37 mm). Greater than 97% of thrombosis sites were located proximal to 75% of graft insertion sites. Coronary arterial bypass grafts provide the coverage of anatomic zones at risk for STEMI. The superior performance of CABG in high risk patients may be attributed to targeting of proximal coronary locations where thrombosis risk is clustered.