A Randomized Trial of Mesenchymal Stromal Cells for Moderate to Severe Acute Respiratory Distress Syndrome from COVID-19.

Rationale: There are limited therapeutic options for patients with coronavirus disease (COVID-19)-related acute respiratory distress syndrome with inflammation-mediated lung injury. Mesenchymal stromal cells offer promise as immunomodulatory agents. Objectives: Evaluation of efficacy and safety of allogeneic mesenchymal cells in mechanically-ventilated patients with moderate or severe COVID-19-induced respiratory failure. Methods: Patients were randomized to two infusions of 2 million cells/kg or sham infusions, in addition to the standard of care. We hypothesized that cell therapy would be superior to sham control for the primary endpoint of 30-day mortality. The key secondary endpoint was ventilator-free survival within 60 days, accounting for deaths and withdrawals in a ranked analysis. Measurements and Main Results: At the third interim analysis, the data and safety monitoring board recommended that the trial halt enrollment as the prespecified mortality reduction from 40% to 23% was unlikely to be achieved (n = 222 out of planned 300). Thirty-day mortality was 37.5% (42/112) in cell recipients versus 42.7% (47/110) in control patients (relative risk [RR], 0.88; 95% confidence interval, 0.64-1.21; P = 0.43). There were no significant differences in days alive off ventilation within 60 days (median rank, 117.3 [interquartile range, 60.0-169.5] in cell patients and 102.0 [interquartile range, 54.0-162.5] in control subjects; higher is better). Resolution or improvement of acute respiratory distress syndrome at 30 days was observed in 51/104 (49.0%) cell recipients and 46/106 (43.4%) control patients (odds ratio, 1.36; 95% confidence interval, 0.57-3.21). There were no infusion-related toxicities and overall serious adverse events over 30 days were similar. Conclusions: Mesenchymal cells, while safe, did not improve 30-day survival or 60-day ventilator-free days in patients with moderate and/or severe COVID-19-related acute respiratory distress syndrome.

Rationale and design of a randomized trial evaluating an external support device for saphenous vein coronary grafts.

BACKGROUND: Coronary artery bypass grafting (CABG) is the most common revascularization approach for the treatment of multi-vessel coronary artery disease. While the internal mammary artery is nearly universally used to bypass the left anterior descending coronary artery, autologous saphenous vein grafts (SVGs) are still the most frequently used conduits to grafts the remaining coronary artery targets. Long-term failure of these grafts, however, continues to limit the benefits of surgery. METHODS: The Cardiothoracic Surgical Trials Network trial of the safety and effectiveness of a Venous External Support (VEST) device is a randomized, multicenter, within-patient trial comparing VEST-supported versus unsupported saphenous vein grafts in patients undergoing CABG. Key inclusion criteria are the need for CABG with a planned internal mammary artery to the left anterior descending and two or more saphenous vein grafts to other coronary arteries. The primary efficacy endpoint of the trial is SVG intimal hyperplasia (plaque + media) area assessed by intravascular ultrasound at 12 months post randomization. Occluded grafts are accounted for in the analysis of the primary endpoint. Secondary confirmatory endpoints are lumen diameter uniformity and graft failure (>50% stenosis) assessed by coronary angiography at 12 months. The safety endpoints are the occurrence of major adverse cardiac and cerebrovascular events and hospitalization within 5 years from randomization. CONCLUSIONS: The results of the VEST trial will determine whether the VEST device can safely limit SVG intimal hyperplasia in patients undergoing CABG as treatment for coronary atherosclerotic disease.

Outcomes following revascularization with radial artery bypass grafts: Insights from the PREVENT-IV trial.

BACKGROUND: The optimal role of radial artery grafts in coronary artery bypass grafting (CABG) remains uncertain. The purpose of this study was to examine angiographic and clinical outcomes following CABG among patients who received a radial artery graft. METHODS: Patients in the angiographic cohort of the PREVENT-IV trial were stratified based upon having received a radial artery graft or not during CABG. Baseline characteristics and 1-year angiographic and 5-year clinical outcomes were compared between patients. RESULTS: Of 1,923 patients in the angiographic cohort of PREVENT-IV, 117 received a radial artery graft. These patients had longer surgical procedures (median 253 vs 228 minutes, P < .001) and had a greater number of grafts placed (P < .0001). Radial artery grafts had a graft-level failure rate of 23.0%, which was similar to vein grafts (25.2%) and higher than left internal mammary artery grafts (8.3%). The hazard of the composite clinical outcome of death, myocardial infarction, or repeat revascularization was similar for both cohorts (adjusted hazard ratio 0.896, 95% CI 0.609-1.319, P = .58). Radial graft failure rates were higher when used to bypass moderately stenotic lesions (<75% stenosis, 37% failure) compared with severely stenotic lesions (≥75% stenosis, 15% failure). CONCLUSIONS: Radial artery grafts had early failure rates comparable to saphenous vein and higher than left internal mammary artery grafts. Use of a radial graft was not associated with a different rate of death, myocardial infarction, or postoperative revascularization. Despite the significant potential for residual confounding associated with post hoc observational analyses of clinical trial data, these findings suggest that when clinical circumstances permit, the radial artery is an acceptable alternative to saphenous vein and should be used to bypass severely stenotic target vessels.

Enhanced recovery after cardiac surgery program to improve patient outcomes.

This article details the obstacles of implementing a cardiac-specific enhanced recovery after surgery (ERAS) program in a 919-bed not-for-profit community-based health system and the benefits of ERAS programs for different patient populations.

Use of Adjuncts Reduces Cardiopulmonary Bypass Time During Minimally Invasive Aortic Valve Replacement.

BACKGROUND: Minimally invasive aortic valve replacement (MIAVR) through a mini-thoracotomy is comparable to AVR through a sternotomy, but may have increased surgical times. The development of adjuncts such as the automatic knot fastener and percutaneous coronary sinus (CS) catheter may reduce this disadvantage. METHODS: A retrospective review conducted between 2002 and 2015 at a single institution revealed 78 patients who underwent MIAVR with adjuncts. The automatic knot fastener was used on all patients, and a successful CS catheter was placed and confirmed by echocardiography in 67 patients (86%). Patients were propensity matched against those who had MIAVR without adjuncts (n = 78) and through a median sternotomy (n = 78) for assessment of major morbidity. Variables were compared using an unpaired t-test, Wilcoxon rank sum test, chi-squared and Fisher's exact test where appropriate. RESULTS: Patients who underwent MIAVR with adjuncts had shorter cross-clamp times (70.5 versus 108.1 and 84.4 min; p <0.0001) and cardiopulmonary bypass (CPB) times (101.1 versus 166.12 and 127.7 min; p <0.0001) than those who underwent MIAVR without adjuncts or through a median sternotomy. Patients who underwent MIAVR received fewer blood transfusions compared to those undergoing AVR via a median sternotomy (0.6 and 1.2 versus 2.5; p <0.012). Patients who underwent MIAVR with adjuncts had similar rates of new-onset atrial fibrillation (AF) than those undergoing MIAVR without adjuncts (33% versus 22%; p = 0.11), but had higher rates of AF compared to the sternotomy group (33% versus 17%; p = 0.02). Rates of in-hospital morbidity and mortality were similar between all groups. CONCLUSIONS: The use of adjuncts during MIAVR led to a significant shortening of cross-clamp and CPB times, and to a requirement for fewer blood transfusions. Morbidity and mortality rates after MIAVR were similar to those in patients undergoing a median sternotomy.

Valve-in-Valve Transcatheter Valve Implantation in the Nonaortic Position.

BACKGROUND: Transcatheter valve-in-valve (VIV) procedures are an alternative to standard surgical valve replacement in high risk patients. METHODS: Cases in which a commercially approved transcatheter aortic valve replacement (TAVR) device was used for a nonaortic VIV procedure between November 2013 and September 2015 are reviewed. Clinical, echocardiographic, and procedural details, patient survival, and symptom severity by NYHA class at follow-up were assessed. RESULTS: All patients were heart-team determined high risk for conventional redo surgery (mean STS PROM = 6.8 ± 2.2%). Five patients underwent VIV replacement in the nonaortic position, four for bioprosthetic mitral valve dysfunction, and one for bioprosthetic tricuspid valve dysfunction. Bioprosthetic failure was due to stenosis in three patients and regurgitation in two others. A balloon-expandable device was used for all patients (Edwards Lifesciences, Irvine, CA, USA). Transcatheter VIV replacement was accomplished by the transapical (mitral) and transfemoral venous (tricuspid) approaches. Median postoperative length of stay was five days (range 3-12). No deaths occurred at a mean follow-up of 21 months. NYHA class at follow-up decreased from class IV at baseline to class I or II for all patients. No paravalvular leaks greater than trivial were encountered. Median mean gradient following mitral replacement was 6.5 mmHg (range 6-13 mmHg), and following tricuspid replacement was 4 mmHg. Postoperative complications included hematuria, epistaxis, acute kidney injury, and atrial fibrillation. CONCLUSIONS: Transcatheter VIV implantation in the nonaortic position for dysfunctional bioprostheses can be performed safely with favorable clinical outcomes using a balloon expandable TAVR device. doi: 10.1111/jocs.12745 (J Card Surg 2016;31:282-288).

Surgical revascularization is associated with maximal survival in patients with ischemic mitral regurgitation: a 20-year experience.

BACKGROUND: The optimal treatment for ischemic mitral regurgitation remains actively debated. Our objective was to evaluate the relationship between ischemic mitral regurgitation treatment strategy and survival. METHODS AND RESULTS: We retrospectively reviewed patients at our institution diagnosed with significant coronary artery disease and moderate or severe ischemic mitral regurgitation from 1990 to 2009, categorized by medical treatment alone, percutaneous coronary intervention, coronary artery bypass grafting (CABG), or CABG plus mitral valve repair or replacement. Kaplan-Meier methods and multivariable Cox proportional hazards analyses were performed to assess the relationship between treatment strategy and survival, with the use of propensity scores to account for nonrandom treatment assignment. A total of 4989 patients were included: medical treatment alone=36%, percutaneous coronary intervention=26%, CABG=33%, and CABG plus mitral valve repair or replacement=5%. Median follow-up was 5.37 years. Compared with medical treatment alone, significantly lower mortality was observed in patients treated with percutaneous coronary intervention (adjusted hazard ratio, 0.83; 95% confidence interval, 0.76-0.92; P=0.0002), CABG (adjusted hazard ratio, 0.56; 95% confidence interval, 0.51-0.62; P<0.0001), and CABG plus mitral valve repair or replacement (adjusted hazard ratio, 0.69; 95% confidence interval, 0.57-0.82; P<0.0001). There was no significant difference in these results based on mitral regurgitation severity. CONCLUSIONS: Patients with significant coronary artery disease and moderate or severe ischemic mitral regurgitation undergoing CABG alone demonstrated the lowest risk of death. CABG with or without mitral valve surgery was associated with lower mortality than either percutaneous coronary intervention or medical treatment alone.

Endoscopic harvesting device type and outcomes in patients undergoing coronary artery bypass surgery.

OBJECTIVE: To evaluate angiographic and clinical outcomes associated with open and closed dissection tunnel endoscopic vein harvesting (EVH) devices. BACKGROUND: A previous PREVENT-IV (PRoject of Ex-vivo Vein graft ENgineering via Transfection IV) analysis reported that EVH for coronary artery bypass graft surgery was associated with worse outcomes than with traditional vein harvesting; however, outcomes by EVH device type were not available. METHODS: Using data from the PREVENT-IV trial, we compared 1549 patients from 75 surgical sites who underwent EVH with open (n = 390) or closed (n = 1159) harvest tunnel devices. Outcomes included the incidence of vein graft failure at 12 to 18 months and a composite of death, myocardial infarction, and revascularization through 5 years. RESULTS: Among patients undergoing open and closed tunnel EVH, no difference in the per-patient incidence of vein graft failure (43.8% vs 47.1%; adjusted odds ratio, 0.91; 95% confidence interval, 0.53-1.55; P = 0.724) or per-graft incidence of vein graft failure (25.5% vs 25.9%; adjusted odds ratio, 0.96; 95% confidence interval, 0.59-1.55; P = 0.847) was observed. At 5 years, no difference was observed in the primary composite clinical outcome between patients who underwent open and closed system EVH (21.5% vs 23.9%; adjusted hazard ratio, 0.85; 95% confidence interval, 0.66-1.10; P = 0.221). CONCLUSIONS: No differences in angiographic or clinical outcomes were observed among patients who underwent open versus closed tunnel endoscopic harvesting for coronary bypass surgery. These findings suggest that the risks associated with EVH that were reported in a previous PREVENT-IV analysis are not related to a specific EVH device.

Relationship between vein graft failure and subsequent clinical outcomes after coronary artery bypass surgery.

BACKGROUND: Vein graft failure (VGF) is common after coronary artery bypass graft surgery, but its relationship with long-term clinical outcomes is unknown. In this retrospective analysis, we examined the relationship between VGF, assessed by coronary angiography 12 to 18 months after coronary artery bypass graft surgery, and subsequent clinical outcomes. METHODS AND RESULTS: Using the Project of Ex Vivo Vein Graft Engineering via Transfection IV (PREVENT IV) trial database, we studied data from 1829 patients who underwent coronary artery bypass graft surgery and had an angiogram performed up to 18 months after surgery. The main outcome measure was death, myocardial infarction, and repeat revascularization through 4 years after angiography. VGF occurred in 787 of 1829 patients (43%). Clinical follow-up was completed in 97% of patients with angiographic follow-up. The composite of death, myocardial infarction, or revascularization occurred more frequently among patients who had any VGF compared with those who had none (adjusted hazard ratio, 1.58; 95% confidence interval, 1.21-2.06; P=0.008). This was due mainly to more frequent revascularization with no differences in death (adjusted hazard ratio, 1.04; 95% confidence interval, 0.71-1.52; P=0.85) or death or myocardial infarction (adjusted hazard ratio, 1.08; 95% confidence interval, 0.77-1.53; P=0.65). CONCLUSIONS: VGF is common after coronary artery bypass graft surgery and is associated with repeat revascularization but not with death and/or myocardial infarction. Further investigations are needed to evaluate therapies and strategies for decreasing VGF to improve outcomes in patients undergoing coronary artery bypass graft surgery.

Saphenous vein graft failure and clinical outcomes: toward a surrogate end point in patients following coronary artery bypass surgery?

Saphenous vein graft (SVG) failure is a common finding in patients following coronary artery bypass graft (CABG) surgery. In the literature SVG failure rates have been reported from 25 to over 50% within 10 years. Although common, it remains unclear to what extent SVG failure affects clinical outcome, due to differences in definition, patient selection and follow-up. Particularly the lack of agreement on a universal definition makes comparisons between studies, and therefore generalizability of associations with outcomes, challenging. We suggest using a definition of SVG failure that is based on imaging as well as clinical parameters, that includes reporting SVG failure on both graft and patient level. The use of non-invasive imaging may help improve follow-up rates, and provide a more accurate picture of the real incidence and clinical impact of SVG failure. Given the lack of supportive evidence showing a consistent association between SVG failure and major adverse cardiovascular events, SVG failure should not be considered a valid surrogate endpoint at this time.

Results with an algorithmic approach to hybrid repair of the aortic arch.

OBJECTIVE: Hybrid repair of the transverse aortic arch may allow for aortic arch repair with reduced morbidity in patients who are suboptimal candidates for conventional open surgery. We present our results with an algorithmic approach to hybrid arch repair, based on the extent of aortic disease and patient comorbidities. METHODS: Between August 2005 and January 2012, 87 patients underwent hybrid arch repair by three principal procedures: zone 1 endograft coverage with extra-anatomic left carotid revascularization (zone 1; n = 19), zone 0 endograft coverage with aortic arch debranching (zone 0; n = 48), or total arch replacement with staged stented elephant trunk completion (stented elephant trunk; n = 20). RESULTS: The mean patient age was 64 years, and the mean expected in-hospital mortality rate was 16.3% as calculated by the EuroSCORE II. Of operations, 22% (n = 19) were nonelective. Sternotomy, cardiopulmonary bypass, and deep hypothermic circulatory arrest were required in 78% (n = 68), 45% (n = 39), and 31% (n = 27) of patients to allow for total arch replacement, arch debranching, or other concomitant cardiac procedures, including ascending with or without hemiarch replacement in 17% (n = 8) of patients undergoing zone 0 repair. All stented elephant trunk procedures (n = 20) and 19% (n = 9) of zone 0 procedures were staged, with 41% (n = 12) of patients undergoing staged repair during a single hospitalization. The 30-day/in-hospital rates of stroke and permanent paraplegia or paraparesis were 4.6% (n = 4) and 1.2% (n = 1). Of 27 patients with native ascending aorta zone 0 proximal landing zone, three (11.1%) experienced retrograde type A dissection after endograft placement. The overall in-hospital mortality rate was 5.7% (n = 5); however, 30-day/in-hospital mortality increased to 14.9% (n = 13) owing to eight 30-day out-of-hospital deaths. Native ascending aorta zone 0 endograft placement was found to be the only univariate predictor of 30-day in-hospital mortality (odds ratio, 4.63; 95% confidence interval, 1.35-15.89; P = .02). Over a mean follow-up period of 28.5 ± 22.2 months, 13% (n = 11) of patients required reintervention for type 1A (n = 4), type 2 (n = 6), or type 3 (n = 1) endoleak. Kaplan-Meier estimates of survival at 1 year, 3 years, and 5 years were 73%, 60%, and 51%. CONCLUSIONS: Hybrid aortic arch repair can be tailored to patient anatomy and comorbid status to allow complete repair of aortic pathology, frequently in a single stage, with acceptable outcomes. However, endograft placement in the native ascending aorta is associated with high rates of retrograde type A dissection and 30-day/in-hospital mortality and should be approached with caution.

Would tirofiban have been shown non-inferior to abciximab had the TENACITY trial not been terminated for financial reasons?

OBJECTIVES: To investigate whether tirofiban would have been non-inferior to abciximab had the trial completed enrollment and place the termination of this trial in a broader research ethics context. BACKGROUND: TENACITY was terminated by the sponsor for financial reasons. At the time, event rates for the 2 treatment arms were unknown. METHODS: TENACITY was designed to compare tirofiban with abciximab in approximately 8,000 patients; however, enrollment was terminated after 383 (4.8%) patients. The primary end-point was a composite of 30-day death, myocardial infarction, and urgent target vessel revascularization. Non-inferiority was defined as the likelihood that tirofiban would preserve at least 50% of the ability of abciximab to reduce the primary end-point at 30 days, based on abciximab's demonstrated ability to reduce such events by 43% (relative risk, 0.573; 95% confidence interval [CI], 0.507-0.648; P < 0.001). To determine the probability of non-inferiority given the patients already enrolled, a Bayesian approach was used. RESULTS: The primary composite end-point occurred in 8.8% of patients randomized to abciximab versus 6.9% receiving high-bolus-dose tirofiban (odds ratio, 0.77; 95% CI, 0.37-1.64). The estimated conditional power for the test that tirofiban would be non-inferior to abciximab if all patients been enrolled is 93.7%. Using the estimated predictive power method, the likelihood was 84.8%. CONCLUSIONS: TENACITY was well powered to identify non-inferiority with tirofiban versus abciximab, and the patients enrolled strengthened the probability that this would have been the outcome had the trial been completed. When a clinical trial is terminated solely for financial reasons, it is incumbent upon the sponsor to provide proper patient follow-up and publication of the findings.

Relationship between postoperative clopidogrel use and subsequent angiographic and clinical outcomes following coronary artery bypass grafting.

Dual antiplatelet therapy with both aspirin and clopidogrel is increasingly used after coronary artery bypass grafting (CABG); however, little is known about the safety or efficacy. We sought to determine the relationship between postoperative clopidogrel and clinical and angiographic outcomes following CABG. We evaluated 3,014 patients from PREVENT IV who underwent CABG at 107 US sites. Postoperative antiplatelet therapy was left to physician discretion. Risk-adjusted angiographic and clinical outcomes were compared in patients taking and not taking clopidogrel 30 days post-CABG. At 30 days, 633 (21%) patients were taking clopidogrel. Clopidogrel users were more likely to have peripheral vascular (15 vs. 11%) and cerebrovascular disease (17 vs. 11%), prior myocardial infarction (MI) (46 vs. 41%), and off-pump surgery (33 vs. 18%). Clopidogrel use was associated with statistically insignificant higher graft failure (adjusted odds ratio 1.3; 95% confidence interval [CI] [1.0, 1.7]; P = 0.05). At 5-year follow-up, clopidogrel use was associated with similar composite rates of death, MI, or revascularization (27 vs. 24%; adjusted hazard ratio 1.1; 95% CI [0.9, 1.4]; P = 0.38) compared with those not using clopidogrel. There was an interaction between use of cardiopulmonary bypass and clopidogrel with a trend toward lower 5-year clinical events with clopidogrel in patients undergoing off-pump CABG. In this observational analysis, clopidogrel use was not associated with better 5-year outcomes following CABG. There may be better outcomes with clopidogrel among patients having off-pump surgery. Adequately powered randomized clinical trials are needed to determine the role of dual antiplatelet therapy after CABG.

The Impact of Vaping on Primary Spontaneous Pneumothorax Outcomes.

INTRODUCTION: Cigarette smoking is associated with primary spontaneous pneumothorax (PSP). Electronic cigarettes (E-cigarettes) are touted as a healthier alternative to cigarettes; however, the impact E-cigarette use has on PSP management is not known. The goal of this study was to determine if E-cigarette use is associated with inferior outcomes after PSP, compared to never smokers and cigarette smokers. METHODS: We conducted a retrospective cohort study of patients in a large tertiary care hospital system in an urban area who presented with PSP from September 2015 through February 2019. Primary spontaneous pneumothorax patients were identified from the institutional Society of Thoracic Surgeon (STS) database. Patients with pneumothoraces from traumatic, iatrogenic, and secondary etiologies were excluded. Baseline clinical and demographic data and outcomes including intervention(s) required, length of stay, and recurrence were evaluated. RESULTS: Identified were 71 patients with PSP. Seventeen (24%) had unverifiable smoking history. Of the remaining, 7 (13%) currently vaped, 27(50%) currently smoked cigarettes, and 20(37%) were never smokers. Mean age was 33 years; 80% male. All vapers required tube thoracostomy vs 74% of current smokers and 75% of never smokers. Vaping was associated with increased odds of recurrence compared to never smokers (OR 2.00, 95% CI 0.35,11.44). Vapers had the shortest median time to recurrence after initial hospitalization (10 d[4,18] v 20 d[5,13] cigarette smokers v 27 d[13 275] never smokers, P < .001). CONCLUSION: Vaping may complicate PSP outcomes. As vaping use increases, especially among adolescents, it is imperative that the manner of tobacco use is documented and considered when caring for patients, especially those with pulmonary problems.

A signature of pre-operative biomarkers of cellular senescence to predict risk of cardiac and kidney adverse events after cardiac surgery.

Objective: Understand the potential for pre-operative biomarkers of cellular senescence, a primary aging mechanism, to predict risk of cardiac surgery-associated adverse events. Methods: Biomarkers of senescence were assessed in blood samples collected prior to surgery in 331 patients undergoing CABG +/-valve repair or replacement. Patients were followed throughout the hospital stay and at a 30-day follow-up visit. Logistic regression models for pre-operative risk prediction were built for age-related clinical outcomes with high incidence including KDIGO-defined acute kidney injury (AKI), decline in eGFR ≥25% between pre-op and 30 days, and MACKE30, a composite endpoint of major adverse cardiac and kidney events at 30d. Results: AKI occurred in 19.9% of patients, persistent decline in kidney function at 30d occurred in 11.0%, and MACKE30 occurred in 13.4%. A network of six biomarkers of senescence (p16, p14, LAG3, CD244, CD28 and suPAR) were able to identify patients at risk for AKI (AUC 0.76), kidney decline at 30d (AUC 0.73), and MACKE30 (AUC 0.71). Comparing the top and bottom tertiles of senescence-based risk models, patients in the top tertile had 7.8 (3.3-8.4) higher odds of developing AKI, 4.5 (1.6-12.6) higher odds of developing renal decline at 30d, and 5.7 (2.1-15.6) higher odds of developing MACKE30. All models remained significant when adjusted for clinical variables. Patients with kidney function decline at 30d were largely non-overlapping and clinically distinct from those who experienced AKI, suggesting a different etiology. Typical clinical factors that predispose to AKI (e.g., age, CKD, surgery type) associated with AKI but not the 30d decline endpoint which was instead associated with new-onset atrial fibrillation. Conclusions: A six-member network of biomarkers of senescence, a fundamental mechanism of aging, can identify patients for risk of adverse kidney and cardiac events when measured pre-operatively.

Eliminating sternal wound infections: Why every cardiac surgery program needs an I hate infections team.

Objectives: The majority of studies examining deep sternal wound infection (DSWI) prevention focus on ameliorating 1 variable at a time. There is a paucity of data regarding the synergistic effects of combining clinical and environmental interventions. This article describes an interdisciplinary, multimodal approach to eliminate DSWIs at a large community hospital. Methods: We developed a robust, multidisciplinary infection prevention team to evaluate and act in all phases of perioperative care to achieve a cardiac surgery DSWI rate of 0, named: the I hate infections team. The team identified opportunities for improved care and best practices and implemented changes on an ongoing basis. Results: Patient-related interventions consisted of preoperative methicillin-resistant Staphylococcus aureus identification, individualized perioperative antibiotics, antimicrobial dosing strategies, and maintenance of normothermia. Operative-related interventions involved glycemic control, sternal adhesives, medications and hemostasis, rigid sternal fixation for high-risk patients, chlorhexidine gluconate dressings over invasive lines, and use of disposable health care equipment. Environment-related interventions included optimizing operating room ventilation and terminal cleaning, reducing airborne particle counts, and decreasing foot traffic. Together, these interventions reduced the DSWI incidence from 1.6% preintervention to 0% for 12 consecutive months after full bundle implementation. Conclusions: A multidisciplinary team focused on eliminating DSWI identified known risk factors and implemented evidence-based interventions in each phase of care to ameliorate risk. Although the influence of each individual intervention on DSWI remains unknown, use of the bundled infection prevention approach reduced the incidence to 0 for the first 12 months after implementation.

Secondary prevention after coronary artery bypass graft surgery: findings of a national randomized controlled trial and sustained society-led incorporation into practice.

BACKGROUND: Despite evidence supporting the use of aspirin, ß-blockers, angiotensin-converting enzyme inhibitors, and lipid-lowering therapies in eligible patients, adoption of these secondary prevention measures after coronary artery bypass grafting has been inconsistent. We sought to rigorously test on a national scale whether low-intensity continuous quality improvement interventions can be used to speed secondary prevention adherence after coronary artery bypass grafting. METHODS AND RESULTS: A total of 458 hospitals participating in the Society of Thoracic Surgeons National Cardiac Database and treating 361 328 patients undergoing isolated coronary artery bypass grafting were randomized to either a control or an intervention group. The intervention group received continuous quality improvement materials designed to influence the prescription of the secondary prevention medications at discharge. The primary outcome measure was discharge prescription rates of the targeted secondary prevention medications at intervention versus control sites, assessed by measuring preintervention and postintervention site differences. Prerandomization treatment patterns and baseline data were similar in the control (n=234) and treatment (n=224) groups. Individual medication use and composite adherence increased over 24 months in both groups, with a markedly more rapid rate of adherence uptake among the intervention hospitals and a statistically significant therapy hazard ratio in the intervention versus control group for all 4 secondary prevention medications. CONCLUSIONS: Provider-led, low-intensity continuous quality improvement efforts can improve the adoption of care processes into national practice within the context of a medical specialty society infrastructure. The findings of the present trial have led to the incorporation of study outcome metrics into a medical society rating system for ongoing quality improvement.

Relationship of the time interval between cardiac catheterization and elective coronary artery bypass surgery with postprocedural acute kidney injury.

BACKGROUND: Some prior studies have suggested that the time to cardiac surgery after cardiac catheterization is inversely related to postoperative acute kidney injury (AKI). However, these studies, because of the small number of patients, were unable to adequately account for patient case-mix and included both those undergoing elective surgery and those undergoing urgent surgery. METHODS AND RESULTS: We examined data on 2441 consecutive patients undergoing elective coronary artery bypass surgery (CABG) after cardiac catheterization. The association of post-CABG AKI (defined as increase in post-CABG serum creatinine ≥ 50% above baseline or the need for new dialysis) and time between cardiac catheterization and CABG was evaluated using multivariable logistic regression modeling. AKI occurred in 17.1% of CABG patients. The risk of AKI was highest in patients in whom CABG was performed ≤ 1 day after cardiac catheterization (adjusted mean rates [95% CI]: 24.0% [18.0%, 30.9%], 18.4% [14.8%, 22.5%], 17.3% [13.3%, 21.9%], 16.4% [12.6%, 20.8%], and 15.8% [13.7%, 18.0%] for days ≤ 1, 2, 3, 4, and ≥ 5, respectively; P=0.019 for test of trend). Post-CABG AKI was associated with increased risk of long-term death (hazard ratio 1.268, 95% CI 1.093, 1.471). CONCLUSIONS: The risk of post-CABG AKI was inversely and modestly related to the time between cardiac catheterization and CABG, with the highest incidence in those operated ≤ 1 day after cardiac catheterization despite their lower risk profile. Whether delaying elective CABG >24 hours of exposure to contrast agents (when feasible) has the potential for decreasing post-CABG AKI remains to be evaluated in future studies.

Edifoligide and long-term outcomes after coronary artery bypass grafting: PRoject of Ex-vivo Vein graft ENgineering via Transfection IV (PREVENT IV) 5-year results.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.