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Edifoligide, an E2F transcription factor decoy, does not prevent vein graft failure or adverse clinical outcomes at 1 year in patients undergoing coronary artery bypass grafting (CABG). We compared the 5-year clinical outcomes of patients in PREVENT IV treated with edifoligide and placebo to identify predictors of long-term clinical outcomes. A total of 3,014 patients undergoing CABG with at least 2 planned vein grafts were enrolled. Kaplan-Meier curves were generated to compare the long-term effects of edifoligide and placebo. A Cox proportional hazards model was constructed to identify factors associated with 5-year post-CABG outcomes. The main outcome measures were death, myocardial infarction (MI), repeat revascularization, and rehospitalization through 5 years. Five-year follow-up was complete in 2,865 patients (95.1%). At 5 years, patients randomized to edifoligide and placebo had similar rates of death (11.7% and 10.7%, respectively), MI (2.3% and 3.2%), revascularization (14.1% and 13.9%), and rehospitalization (61.6% and 62.5%). The composite outcome of death, MI, or revascularization occurred at similar frequency in patients assigned to edifoligide and placebo (26.3% and 25.5%, respectively; hazard ratio 1.03 [95% CI 0.89-1.18], P = .721). Factors associated with death, MI, or revascularization at 5 years included peripheral and/or cerebrovascular disease, time on cardiopulmonary bypass, lung disease, diabetes mellitus, and congestive heart failure. Up to a quarter of patients undergoing CABG will have a major cardiac event or repeat revascularization procedure within 5 years of surgery. Edifoligide does not affect outcomes after CABG; however, common identifiable baseline and procedural risk factors are associated with long-term outcomes after CABG.

It is unclear if surgical exposure confers a risk advantage compared with a percutaneous approach for patients undergoing endovascular procedures requiring large-bore femoral artery access. From the randomized controlled Placement of Aortic Transcatheter Valve trials A and B and the continued access registries, a total of 1,416 patients received transfemoral transcatheter aortic valve replacement, of which 857 underwent surgical, and 559 underwent percutaneous access. Thirty-day rates of major vascular complications and quality of life scores were assessed. Propensity matching was used to adjust for unmeasured confounders. Overall, there were 116 major vascular complications (8.2%). Complication rates decreased dramatically during the study period. In unadjusted analysis, major vascular complications were significantly less common in the percutaneous access group (35 [6.3%] vs 81 [9.5%] p = 0.032). However, among 292 propensity-matched pairs, there was no difference in major vascular complications (22 [7.5%] vs 28 [9.6%], p = 0.37). Percutaneous access was associated with fewer total in-hospital vascular complications (46 [16%] vs 66 [23%], p = 0.036), shorter median procedural duration (97 interquartile range [IQR 68 to 166] vs 121 [IQR 78 to 194] minutes, p <0.0001), and median length of stay (4 [IQR 2 to 8] vs 6 [IQR 3 to 10] days, p <0.0001). There were no significant differences in quality of life scores at 30 days. Surgical access for large-bore femoral access does not appear to confer any advantages over percutaneous access and may be associated with more minor vascular complications.

Transcatheter aortic valve implantation (TAVI) for isolated aortic regurgitation (AR) comprises <1.0% of all TAVI procedures performed in the USA. In this manuscript, we review the challenges, evidence and future directions of TAVI for isolated AR. There are no randomised clinical trials or mid-term data evaluating TAVI for isolated AR, and no commercially available devices are approved for this indication. Challenges in performing TAVI for isolated AR as opposed to aortic stenosis (AS) include: lack of a calcified anchoring zone for valve deployment, large and dynamic size of the aortic annulus and high stroke volume (during systole) and regurgitant volume (during diastole) across the aortic annulus during each cardiac cycle. Observational studies have shown that outcomes of TAVI for AR are worse than outcomes of TAVI for AS. However, newer generation TAVI devices may perform better than older generation devices in patients with AR. Two emerging valves (the JenaValve and the J-Valve) are designed with mechanisms to anchor in a non-calcified annulus, and these valves have shown promise for AR. Data on these devices are limited, and clinical investigation is ongoing. Randomised clinical trials are needed to establish TAVI as a safe and effective treatment for isolated AR.

Endoscopic vein-graft harvesting is often used in coronary-artery bypass grafting (CABG) to prevent postoperative wound complications. However, in this study, which had a 3-year follow-up, endoscopic harvesting was associated with a higher rate of graft failure and adverse clinical outcomes. Although this is not a randomized study, it calls into question the use of endoscopic vein-graft harvesting in CABG. Endoscopic vein-graft harvesting is often used in coronary-artery bypass grafting (CABG) to prevent postoperative wound complications. However, in this study, endoscopic harvesting was associated with a higher rate of graft failure and adverse clinical outcomes. Coronary-artery bypass grafting (CABG) is one of the most commonly performed surgical procedures and improves the clinical outcomes in appropriately selected patients. 1 , 2 Despite increased use of an arterial conduit, the greater saphenous vein remains the conduit that is used most often in CABG. 1 Traditionally, the saphenous vein is harvested under direct vision (open harvesting) with the help of linear incisions along the course of the vein. This approach is associated with discomfort and the risk of complications, including edema, hematoma, delayed healing, cellulitis, and wound dehiscence. 3 – 7 Endoscopic vein-graft harvesting, a procedure that was developed to eliminate the need . . .

Data regarding outcomes for patients with severe aortic stenosis (AS) with concomitant aortic insufficiency (AI), undergoing transcatheter aortic valve replacement (TAVR) are limited. This study aimed to analyze the prevalence of severe AS with concomitant AI among patients undergoing TAVR and outcomes of TAVR in this patient group. Using data from the STS/ACC-TVT Registry, we identified patients with severe AS with or without concomitant AI who underwent TAVR between 2011 and 2016. Patients were categorized based on the severity of pre-procedural AI. Multivariable proportional hazards regression models were used to examine all-cause mortality and heart failure (HF) hospitalization at 1-year. Among 54,535 patients undergoing TAVR, 42,568 (78.1%) had severe AS with concomitant AI. Device success was lower in patients with severe AS with concomitant AI as compared with isolated AS. The presence of baseline AI was associated with lower 1 year mortality (HR 0.94 per 1 grade increase in AI severity; 95% CI, 0.91-0.98, P < .001) and HF hospitalization (HR 0.87 per 1 grade increase in AI severity; 95% CI, 0.84-0.91, P < .001). Severe AS with concomitant AI is common among patients undergoing TAVR, and is associated with lower 1 year mortality and HF hospitalization. Future studies are warranted to better understand the mechanisms underlying this benefit. In this nationally representative analysis from the United States, 78.1% of patients undergoing TAVR had severe AS with concomitant AI. Device success was lower in patients with severe AS with concomitant AI as compared with isolated AS. The presence of baseline AI was associated with lower 1 year mortality (HR 0.94 per 1 grade increase in AI severity; 95% CI, 0.91-0.98, P < .001) and HF hospitalization (HR 0.87 per 1 grade increase in AI severity; 95% CI, 0.84-0.91, P < .001).

Objectives Evaluate the cost of illness associated with the 90-day period following acute myocardial infarction (AMI) and the implication of care pathway (percutaneous coronary intervention [PCI] vs medical management [MM]), in order to assess the potential financial risk incurred by providers for AMI as an episode of care. Perspective Reimbursement payment systems for acute care episodes are shifting from 30-day to 90-day bundled payment models. Since follow-up care and readmissions beyond the early days/weeks post-AMI are common, financial risk may be transferred to providers. Setting AMI hospitalization Centers for Medicare & Medicaid Services (CMS) standard analytical files between 10/1/2015 and 9/30/2016 were reviewed. Methods Included patients were Medicare beneficiaries with a primary diagnosis of AMI subsequently treated with either PCI or MM. Payments were standardized to remove geographic variation and separated into reimbursements for services during the hospitalization and from discharge to 90 days post-discharge. Results were stratified by Medicare Severity Diagnosis Related Groups (MS-DRGs) individually and grouped between patients treated with MM and PCI. Risk-adjusted likelihood of utilization of post-acute nursing care and all-cause readmission was assessed by logistic regression. Results A total of 96,546 patients were included in the analysis. The highest total mean payment (US$32,714) was for MS-DRG 248 (PCI with non-drug-eluting stent with major complication or comorbidity). Total payments were similar between MM and PCI patients, but MM patients incurred the majority of costs in the post-acute period after discharge, with the converse true for PCI patients. MM without catheterization was associated with a twofold increase in risk of requiring post-acute nursing care and 90-day readmission versus PCI (odds ratio [95% confidence interval]: 2.01 [1.92–2.11] and 2.17 [2.08–2.27]). Smaller hospital size, diabetes, peripheral arterial disease, prior AMI, and multivessel disease were predictors of higher healthcare utilization. Conclusions MS-DRGs associated with the lowest reimbursements (and presumably, lowest costs of inpatient care) incur the highest post-discharge expenditures. As the CMS Bundled Payment for Care Improvement and similar programs are implemented, there will be a need to account for heterogeneous post-discharge care costs. 4nS-9dkeFQcMwYpb3qZQvc Video abstract (MP4 274659 KB) Plain Language Summary Around 805,000 heart attacks occur annually in the US. With an average age over 65 years, many heart attack patients qualify for Medicare health insurance. Under Medicare, hospitals (or ‘providers’) receive reimbursements for the cost of care associated with ‘acute care episodes’ (e.g., heart attacks) as a ‘bundled’ payment. The bundled reimbursements are typically based on pre-defined prices, with hospitals paying the difference if actual costs exceed these. Reimbursements are typically given for care costs from the initial heart attack through to hospital discharge and care in the 30-day post-discharge period. However, recently introduced reimbursement models such as BPCI Advanced have moved to expand this to 90 days. Since follow-up care and additional cardiovascular readmissions are common beyond 30 days, extension of the reimbursement period to 90 days could increase financial risk to hospitals/providers if these additional costs are not included in reimbursements. To assess the potential impact of this, we investigated the cost of illness for heart attack and the implication of type of care: medical management (standard medication given after heart attack) vs. percutaneous coronary intervention (PCI; standard medication plus a non-surgical procedure to widen heart blood vessels). We found that 90-day costs after heart attack are substantial regardless of type of care. We found that post-discharge costs were generally high, but higher for medically managed patients than those receiving PCI. Our analysis also suggests Medicare disease classifications associated with lowest payments for heart attack (and presumably, lowest hospitalization costs) are associated with the highest post-discharge expenditures. Overall, our study suggests that new payment models should account for variable post-discharge care costs, and new therapies are needed to reduce additional events, readmissions, and associated costs in heart attack patients.

Background To evaluate the midterm results of patients with angina and diffuse coronary artery disease treated with transmyocardial revascularization in combination with autologous stem cell therapy. Methods Nineteen patients with diffuse coronary artery disease and medically refractory class III/IV angina were evaluated between June 2007 and December 2009 for sole therapy TMR combined with intramyocardial injection of concentrated stem cells. At the time of surgery, autologous bone marrow (120cc) was aspirated from the iliac crest. A cardiac MRI and an isotopic test were performed before and after the procedure. Follow-up was performed by personal interview. Results There were no perioperative adverse events including no arrhythmias. Mean number of laser channels was 20 and the mean total number of intramyocardially injected cells per milliliter were: total mononuclear cells(83.6 × 10 6 ), CD34+ cells(0.6 × 10 6 ), and CD133+ cells(0.34 × 10 6 ). At 12 months mean follow-up average angina class was significantly improved (3.4 ± 0.5 vs 1.4 ± 0.6; p = 0.004). In addition, monthly cardiovascular medication usage was significantly decreased (348 ± 118 vs. 201 ± 92; p = 0.001). At six months follow up there was a reduction in the number of cardiac hospital readmissions (2.9 ± 2.3 vs. 0.5 ± 0.8; p < 0.001). MRI showed no alterations regarding LV volumes and a 3% improvement regarding ejection fraction. Conclusions The stem cell isolator efficiently concentrated autologous bone marrow derived stem cells while the TMR/stem cell combination delivery device worked uneventfully. An improvement in clinical status was noticed in the midterm follow-up. Images test showed no morphological alterations in the left ventricle after the procedure.

Despite the success of current medical and surgical management of ischemic heart disease, a growing number of patients have diffuse obstructive coronary artery disease that is not amenable to coronary-artery bypass grafting or catheter-based interventions. This problem has stimulated interest in developing alternative therapeutic approaches. Early attempts at indirect myocardial revascularization had limited success. Beck's use of omentopexy, reported in 1935, 1 and Vinberg's use of thoracic-artery implantation, reported in 1954, 2 were attempts to provide direct myocardial perfusion and were based on the description by Wearn et al., in 1933, 3 of a sinusoidal network in the human heart. In 1965, Sen . . .

Background.  An unmet need to prevent Staphylococcus aureus (SA) infections after cardiothoracic surgery persists despite current practices. Cost-effective implementation of preventive strategies requires contemporary knowledge about modifiable risk factors. Methods.  From 2007 to 2011, an international, double-blind, randomized placebo-controlled trial of a novel SA vaccine (V710) was conducted in 7664 adults scheduled for median sternotomy at 164 sites. We analyzed SA infections developing up to 360 days postoperatively in 3832 placebo recipients. Results.  Coronary artery bypass grafting was performed in 80.8% (3096 of 3832) of placebo recipients. The overall incidence of any postoperative SA infection was 3.1% (120 of 3832). Invasive SA infections (including bacteremia and deep sternal-wound infections) developed in 1.0%. Methicillin-resistant SA (MRSA) accounted for 19% (23 of 120) of SA infections, with 57% (13 of 23) of the MRSA infections occurring in diabetic patients. All-cause mortality was 4.1% (153 of 3712) in patients without SA infection, 7.2% (7 of 97) in methicillin-susceptible SA (MSSA) infections, and 17.3% (4 of 23) in MRSA infections (P < .01). Staphylococcus aureus nasal carriage was detected preoperatively in 18.3% (701 of 3096) patients, including 1.6% colonized with MRSA. Postoperative SA infections occurred in 7.0% (49 of 701) of colonized patients versus 2.3% (71 of 3131) of patients without colonization (relative risk = 3.1 [95% confidence interval, 2.2–4.4]). Conclusions.  In this large international cohort of patients undergoing cardiac surgery and observed prospectively, invasive postoperative SA infections occurred in 1% of adult patients despite modern perioperative management. The attributable mortality rates were 3% for MSSA and 13% for MRSA infections. Preoperative nasal colonization with SA increased the risk of postoperative infection threefold. The utility of strategies to reduce this incidence warrants continued investigation.