Surgery for small asymptomatic abdominal aortic aneurysms.

BACKGROUND: An abdominal aortic aneurysm (AAA) is an abnormal ballooning of the major abdominal artery. Some AAAs present as emergencies and require surgery; others remain asymptomatic. Treatment of asymptomatic AAAs depends on many factors, but the size of the aneurysm is important, as risk of rupture increases with aneurysm size. Large asymptomatic AAAs (greater than 5.5 cm in diameter) are usually repaired surgically; very small AAAs (less than 4.0 cm diameter) are monitored with ultrasonography. Debate continues over the roles of early repair versus surveillance with repair on subsequent enlargement in people with asymptomatic AAAs of 4.0 cm to 5.5 cm diameter. This is the fourth update of the review first published in 1999. OBJECTIVES: To compare mortality and costs, as well as quality of life and aneurysm rupture as secondary outcomes, following early surgical repair versus routine ultrasound surveillance in people with asymptomatic AAAs between 4.0 cm and 5.5 cm in diameter. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, two other databases, and two trials registers to 10 July 2019. We handsearched conference proceedings and checked reference lists of relevant studies. SELECTION CRITERIA: We included randomised controlled trials where people with asymptomatic AAAs of 4.0 cm to 5.5 cm were randomly allocated to early repair or imaging-based surveillance at least every six months. Outcomes had to include mortality or survival. DATA COLLECTION AND ANALYSIS: Three review authors independently extracted data, which were cross-checked by other team members. Outcomes were mortality, costs, quality of life, and aneurysm rupture. For mortality, we estimated risk ratios (RR) (endovascular aneurysm repair only), hazard ratios (HR) (open repair only), and 95% confidence intervals (CI) based on Mantel-Haenszel Chi2 statistics at one and six years (open repair only) following randomisation. MAIN RESULTS: We found no new studies for this update. Four trials with 3314 participants fulfilled the inclusion criteria. Two trials compared early open repair with surveillance and two trials compared early endovascular repair (EVAR) with surveillance. We used GRADE to access the certainty of the evidence for mortality and cost, which ranged from high to low. We downgraded the certainty in the evidence from high to moderate and low due to risk of bias concerns and imprecision (some outcomes were only reported by one study). All four trials showed an early survival benefit in the surveillance group (due to 30-day operative mortality with repair) but no evidence of differences in long-term survival. One study compared early open repair with surveillance with an adjusted HR of 0.88 (95% CI 0.75 to 1.02, mean follow-up 10 years; HR 1.21, 95% CI 0.95 to 1.54, mean follow-up 4.9 years). Pooled analysis of participant-level data from the two trials comparing early open repair with surveillance (maximum follow-up seven to eight years) showed no evidence of a difference in survival (propensity score-adjusted HR 0.99, 95% CI 0.83 to 1.18; 2226 participants; high-certainty evidence). This lack of treatment effect did not vary to three years by AAA diameter (P = 0.39), participant age (P = 0.61), or for women (HR 0.84, 95% CI 0.62 to 1.11). Two studies compared EVAR with surveillance and there was no evidence of a survival benefit for early EVAR at 12 months (RR 1.92, 95% CI 0.73 to 5.06; 846 participants; low-certainty evidence). Two trials reported costs. The mean UK health service costs per participant over the first 18 months after randomisation were higher in the open repair surgery than the surveillance group (GBP 4978 in the repair group versus GBP 3914 in the surveillance group; mean difference (MD) GBP 1064, 95% CI 796 to 1332; 1090 participants; moderate-certainty evidence). There was a similar difference after 12 years. The mean USA hospital costs for participants at six months after randomisation were higher in the EVAR group than in the surveillance group (USD 33,471 with repair versus USD 5520 with surveillance; MD USD 27,951, 95% CI 25,156 to 30,746; 614 participants; low-certainty evidence). After four years, there was no evidence of a difference in total medical costs between groups (USD 48,669 with repair versus USD 46,112 with surveillance; MD USD 2557, 95% CI -8043 to 13,156; 614 participants; low-certainty evidence). All studies reported quality of life but used different assessment measurements and results were conflicting. All four studies reported aneurysm rupture. There were very few ruptures reported in the trials of EVAR versus surveillance up to three years. In the trials of open surgery versus surveillance, there were ruptures to at least six years and there were more ruptures in the surveillance group, but most of these ruptures occurred in aneurysms that had exceeded the threshold for surgical repair. AUTHORS' CONCLUSIONS: There was no evidence of an advantage to early repair for small AAA (4.0 cm to 5.5 cm), regardless of whether open repair or EVAR is used and, at least for open repair, regardless of patient age and AAA diameter. Thus, neither early open nor early EVAR of small AAAs is supported by currently available evidence. Long-term data from the two trials investigating EVAR are not available, so, we can only draw firm conclusions regarding outcomes after the first few years for open repair. Research regarding the risks related to and management of small AAAs in ethnic minorities and women is urgently needed, as data regarding these populations are lacking.

The Impact of Aneurysm Morphology and Anatomic Characteristics on Long-Term Survival after Endovascular Abdominal Aortic Aneurysm Repair.

BACKGROUND: Hostile anatomic characteristics in patients undergoing endovascular abdominal aortic aneurysm repair (EVAR) and the placement of endografts not in concordance with the specific device anatomic guidelines (or instructions for use [IFU]) have shown decreased technical success of the procedure. But these factors have never been evaluated in regard to patient postoperative survival. We sought to assess the association between survival and (1) aneurysm anatomy and characteristics and (2) implantation in compliance with manufacturer's anatomic IFU guidelines in patients undergoing endovascular aortic aneurysm repair. METHODS: The cohort included 273 consecutive patients who underwent EVAR at Baylor Heart and Vascular Hospital between January 1, 2002 and December 31, 2009 and had their preoperative computed tomography (CT) scan digitally retrievable. The CT scans and operative notes were then reviewed, and the anatomic severity grading (ASG) score, maximum aneurysm diameter, thrombus width, patency of aortic side branch vessels, and implantation in compliance with IFU guidelines were assessed. The unadjusted association between survival (assessed until November 1, 2011) and these variables was assessed with the Kaplan-Meier method. Moreover, propensity-adjusted (for a comprehensive array of clinical and nonclinical risk factors) proportional hazard models were developed to assess the adjusted associations. RESULTS: Seven (2.56%) patients died within 30 days from EVAR, and 88 (30.04%) patients died during the study follow-up. Patient mean survival was 6.3 years. The unadjusted analysis showed a statistically significant association between survival and thrombus width (P = 0.007), ASG score (P = 0.004), and implantation in compliance with IFU guidelines (P = 0.007). However, the adjusted analysis revealed that none of the anatomic and compliance factors were significantly associated with long-term survival (ASG, P = 0.149; diameter, P = 0.836; thrombus, P = 0.639; patency, P = 0.219; and implantation compliance, P = 0.219). CONCLUSIONS: Unfavorable aneurysm morphologic characteristics and endograft implantation not in compliance with IFU guidelines did not adversely affect patient survival after EVAR in this group of patients. This implies that unfavorable anatomy, even that which would necessitate implantation of the EVAR device outside of the IFU guidelines, should not necessarily contraindicate EVAR.

The Society of Thoracic Surgeons voluntary public reporting initiative: the first 4 years.

OBJECTIVES: To evaluate participant characteristics and outcomes during the first 4 years of the Society of Thoracic Surgeons (STS) public reporting program. BACKGROUND: This is the first detailed analysis of a national, voluntary, cardiac surgery public reporting program using STS clinical registry data and National Quality Forum-endorsed performance measures. METHODS: The distributions of risk-adjusted mortality rates, multidimensional composite performance scores, star ratings, and volumes for public reporting versus nonreporting sites were studied during 9 consecutive semiannual reporting periods (2010-2014). RESULTS: Among 8929 unique observations (∼1000 STS participant centers, 9 reporting periods), 916 sites (10.3%) were classified low performing, 6801 (76.2%) were average, and 1212 (13.6%) were high performing. STS public reporting participation varied from 22.2% to 46.3% over the 9 reporting periods. Risk-adjusted, patient-level mortality rates for isolated coronary artery bypass grafting were consistently lower in public reporting versus nonreporting sites (P value range: <0.001-0.0077). Reporting centers had higher composite performance scores and star ratings (23.2% high performing and 4.5% low performing vs 7.6% high performing and 13.8% low performing for nonreporting sites). STS public reporting sites had higher mean annualized coronary artery bypass grafting volumes than nonreporting sites (169 vs 145, P < 0.0001); high-performing programs had higher mean coronary artery bypass grafting volumes (n = 241) than average (n = 139) or low-performing (n = 153) sites. Risk factor prevalence (except reoperation) and expected mortality rates were generally stable during the study period. CONCLUSIONS: STS programs that voluntarily participate in public reporting have significantly higher volumes and performance. No evidence of risk aversion was found.

Surgery for small asymptomatic abdominal aortic aneurysms.

BACKGROUND: An abdominal aortic aneurysm (AAA) is an abnormal ballooning of the major abdominal artery. Some AAAs present as emergencies and require surgery; others remain asymptomatic. Treatment of asymptomatic AAAs depends on many factors, but an important one is the size of the aneurysm, as risk of rupture increases with aneurysm size. Large asymptomatic AAAs (greater than 5.5 cm in diameter) are usually repaired surgically; very small AAAs (less than 4.0 cm diameter) are monitored with ultrasonography. Debate continues over the appropriate roles of immediate repair and surveillance with repair on subsequent enlargement in people presenting with asymptomatic AAAs of 4.0 cm to 5.5 cm diameter. This is the third update of the review first published in 1999. OBJECTIVES: To compare mortality, quality of life, and cost effectiveness of immediate surgical repair versus routine ultrasound surveillance in people with asymptomatic AAAs between 4.0 cm and 5.5 cm in diameter. SEARCH METHODS: For this update, the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (February 2014) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 1). We checked reference lists of relevant articles for additional studies. SELECTION CRITERIA: Randomised controlled trials in which men and women with asymptomatic AAAs of diameter 4.0 cm to 5.5 cm were randomly allocated to immediate repair or imaging-based surveillance at least every six months. Outcomes had to include mortality or survival. DATA COLLECTION AND ANALYSIS: Three members of the review team independently extracted the data, which were cross-checked by other team members. Risk ratios (RR) (endovascular aneurysm repair only), hazard ratios (HR) (open repair only), and 95% confidence intervals based on Mantel-Haenszel Chi(2) statistic were estimated at one and six years (open repair only) following randomisation. We included all relevant published studies in this review. MAIN RESULTS: For this update, four trials with a combined total of 3314 participants fulfilled the inclusion criteria. Two trials compared surveillance with immediate open repair; two trials compared surveillance with immediate endovascular repair. Overall, the risk of bias within the included studies was low and the quality of the evidence high. The four trials showed an early survival benefit in the surveillance group (due to 30-day operative mortality with surgery) but no significant differences in long-term survival (adjusted HR 0.88, 95% confidence interval (CI) 0.75 to 1.02, mean follow-up 10 years; HR 1.21, 95% CI 0.95 to 1.54, mean follow-up 4.9 years; HR 0.76, 95% CI 0.30 to 1.93, median follow-up 32.4 months; HR 1.01, 95% CI 0.49 to 2.07, mean follow-up 20 months). A pooled analysis of participant-level data from two trials (with a maximum follow-up of seven to eight years) showed no statistically significant difference in survival between immediate open repair and surveillance (propensity score-adjusted HR 0.99; 95% CI 0.83 to 1.18), and that this lack of treatment effect did not vary by AAA diameter (P = 0.39) or participant age (P = 0.61). The meta-analysis of mortality at one year for the endovascular trials likewise showed no significant association (RR at one year 1.15, 95% CI 0.60 to 2.17). Quality-of-life results among trials were conflicting. AUTHORS' CONCLUSIONS: The results from the four trials to date demonstrate no advantage to immediate repair for small AAA (4.0 cm to 5.5 cm), regardless of whether open or endovascular repair is used and, at least for open repair, regardless of patient age and AAA diameter. Thus, neither immediate open nor immediate endovascular repair of small AAAs is supported by currently available evidence.

Risk of Transfusion in Isolated Coronary Artery Bypass Graft: Models developed from the STS Database.

BACKGROUND: Perioperative blood transfusion is associated with adverse outcomes and higher costs following coronary artery bypass graft surgery (CABG). We developed risk assessments for patients' probability of perioperative transfusion and the expected transfusion volume, to improve clinical management and resource use. METHODS: Among 1,266,545 consecutive (2008-2016) isolated-CABG operations in STS's Adult Cardiac Surgery Database, 657,821 (51.9%) received perioperative blood transfusions (red blood cell [RBC], fresh frozen plasma [FFP], cryoprecipitate, and/or platelets). We developed "full" models to predict perioperative transfusion of any blood product, and of RBC, FFP, or platelets. Using least absolute shrinkage and selection operator model selection, we built a rapid risk score based on 5 variables (age, body surface area, sex, preoperative hematocrit and use of intra-aortic balloon pump). RESULTS: Full model C-statistics were 0.785, 0.815, 0.707, and 0.699 for any blood product, RBC, FFP, and platelets. Rapid risk assessments' C-statistics were 0.752, 0.785, 0.670, and 0.661 for any blood product, RBC, FFP, and platelets. The observed versus expected risk plots showed strong calibration for full models and risk assessment tools; absolute differences between observed and expected risks of transfusion were <10.8% in each percentile of expected risk. Risk-assessments' predicted probabilities of transfusion were strongly and non-linearly associated (p<.0001) with total units transfused. CONCLUSIONS: These robust and well-calibrated risk assessment tools for perioperative transfusion in CABG can inform surgeons regarding patients' risks and number of RBC, FFP, and platelets units they can expect to need. This can aid in optimizing outcomes and increasing efficient use of blood products.

A pilot study of prasugrel followed by post-procedural maintenance with clopidogrel in patients receiving percutaneous coronary intervention.

BACKGROUND: Dual anti-platelet therapy including clopidogrel or prasugrel is standard of care for patients receiving stents. Prasugrel has quicker onset so it can be loaded later than clopidogrel with greater efficacy. However, prasugrel is much more expensive than clopidogrel. OBJECTIVES: To describe the incidence of 30-day death from cardiovascular causes, myocardial infarction, unstable angina requiring intervention, and minor and major bleeding in patients loaded with 60 mg of prasugrel prior to percutaneous coronary intervention (PCI) and then continued on 75 mg of clopidogrel daily after the procedure. METHODS: We reviewed sequential medical records of 102 patients (Mean age: 67.8, male 68.6%, smokers: 22.6%, BMI: 29.5%, hypertension: 90.2%, DM: 33.3%, average ejection fraction: 49.7%) who underwent PCI (3.9% STEMI, 12.7% NSTEMI, 35.3% unstable angina and 48.1% electively) at Baylor University Medical Center between October 2009 and December 2011 who were loaded with prasugrel 60 mg prior to procedure, and then continued on 75 mg clopidogrel daily. RESULTS: None of the patients died or experienced a myocardial infarction (MI) within 30 days of the procedure. Three patients experienced unstable angina requiring intervention but none had in-stent thrombosis or restenosis on repeat angiography. None of the patients experienced a major bleeding event. One patient developed a gastrointestinal bleed which did not require blood transfusion and the bleeding it resolved on discontinuation of the clopidogrel. CONCLUSION: In this retrospective pilot study, a strategy of loading patients needing PCI with prasugrel 60 mg immediately prior to coronary intervention, then continuation of anti-platelet therapy with 75 mg clopidogrel daily was safe and effective.

Predicting hospital readmission in Medicaid patients with diabetes using administrative and claims data.

OBJECTIVES: Readmission is common and costly for hospitalized Medicaid patients with diabetes. We aimed to develop a model predicting risk of 30-day readmission in Medicaid patients with diabetes hospitalized for any cause. STUDY DESIGN: Using 2016-2019 Medicaid claims from 7 US states, we identified patients who (1) had a diagnosis of diabetes or were prescribed any diabetes drug, (2) were hospitalized for any cause, and (3) were discharged to home or to a nonhospice facility. For each encounter, we assessed whether the patient was readmitted within 30 days of discharge. METHODS: Applying least absolute shrinkage and selection operator variable selection, we included demographic data and claims history in a logistic regression model to predict 30-day readmission. We evaluated model fit graphically and measured predictive accuracy by the area under the receiver operating characteristic curve (AUROC). RESULTS: Among 69,640 eligible patients, there were 129,170 hospitalizations, of which 29,410 (22.8%) were 30-day readmissions. The final model included age, sex, age-sex interaction, past diagnoses, US state of admission, number of admissions in the preceding year, index admission type, index admission diagnosis, discharge status, length of stay, and length of stay-sex interaction. The observed vs predicted plot showed good fit. The estimated AUROC of 0.761 was robust in analyses that assessed sensitivity to a range of model assumptions. CONCLUSIONS: Our model has moderate power for identifying hospitalized Medicaid patients with diabetes who are at high risk of readmission. It is a template for identifying patients at risk of readmission and for adjusting comparisons of 30-day readmission rates among sites or over time.

Comparison of the structure of the aortic valve and ascending aorta in adults having aortic valve replacement for aortic stenosis versus for pure aortic regurgitation and resection of the ascending aorta for aneurysm.

BACKGROUND: There is debate concerning whether an aneurysmal ascending aorta should be replaced when associated with a dysfunctioning aortic valve that is to be replaced. To examine this issue, we divided the patients by type of aortic valve dysfunction-either aortic stenosis (AS) or pure aortic regurgitation (AR)-something not previously undertaken. METHODS AND RESULTS: Of 122 patients with ascending aortic aneurysm (unassociated with aortitis or acute dissection), the aortic valve was congenitally malformed (unicuspid or bicuspid) in 58 (98%) of the 59 AS patients, and in 38 (60%) of the 63 pure AR patients. Ascending aortic medial elastic fiber loss (EFL) (graded 0 to 4+) was zero or 1+ in 53 (90%) of the AS patients, in 20 (53%) of the 38 AR patients with bicuspid valves, and in all 12 AR patients with tricuspid valves unassociated with the Marfan syndrome. An unadjusted analysis showed that, among the 96 patients with congenitally malformed valves, the 38 AR patients had a significantly higher likelihood of 2+ to 4+ EFL than the 58 AS patients (crude odds ratio: 8.78; 95% confidence interval: 2.95, 28.13). CONCLUSIONS: These data strongly suggest that the type of aortic valve dysfunction-AS versus pure AR-is very helpful in predicting loss of aortic medial elastic fibers in patients with ascending aortic aneurysms and aortic valve disease.

Surgery for small asymptomatic abdominal aortic aneurysms.

BACKGROUND: An abdominal aortic aneurysm (AAA) is an abnormal ballooning of the major abdominal artery. Some AAAs present as emergencies and require surgery; others remain asymptomatic. Treatment of asymptomatic AAAs depends on many factors but an important one is size of the aneurysm, as risk of rupture increases with aneurysm size. Large asymptomatic AAAs (> 5.5 cm in diameter) are usually operated on; very small AAAs (< 4.0 cm diameter) are monitored with ultrasonography. The optimal timing of surgery would benefit from further evidence. OBJECTIVES: This review compared long-term survival in patients with AAAs of diameter 4.0 to 5.5 cm who received immediate repair versus routine ultrasound surveillance. SEARCH METHODS: For this update the Cochrane Peripheral Vascular Diseases Group searched their Specialised Register (February 2012) and CENTRAL (2012, Issue 1). Reference lists of relevant articles were checked for additional studies and the searches were supplemented by handsearches of recent conference proceedings and information from experts in the field.  SELECTION CRITERIA: Randomised controlled trials in which men and women with asymptomatic AAAs of diameter 4.0 to 5.5 cm were randomly allocated to immediate repair or imaging-based surveillance at least every six months. Outcomes had to include mortality or survival. DATA COLLECTION AND ANALYSIS: Two authors (GF, MAMM) abstracted the data, which were cross-checked by the other authors (DJB, JTP). Due to the small number of trials, formal tests of heterogeneity and sensitivity analyses were not conducted. MAIN RESULTS: Four trials with a combined total of 3314 patients, the UK Small Aneurysm Trial (UKSAT), the Aneurysm Detection and Management (ADAM) trial, the Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair (CAESAR), and the Positive Impact of Endovascular Options for treating Aneurysms Early (PIVOTAL) fulfilled the inclusion criteria. The four trials showed an early survival benefit in the surveillance group (due to 30-day operative mortality with surgery) but no significant differences in long-term survival (adjusted hazard ratio (HR) 0.88, 95% confidence interval (CI) 0.75 to 1.02, mean follow up 10 years (UKSAT); HR 1.21, 95% CI 0.95 to 1.54, mean follow up 4.9 years (ADAM); HR 0.76, 95% CI 0.30 to 1.93, median follow up 32.4 months (CAESAR); HR 1.01, 95% CI 0.49 to 2.07, mean follow up 20 months (PIVOTAL)). The meta analyses of mortality at one year (CAESAR and PIVOTAL only) and six years (UKSAT and ADAM only) revealed a non-significant association (Peto odds ratio at one year 1.15, 95% CI 0.59 to 2.25; Peto odds ratio at six years 1.11, 95% CI 0.91 to 1.34).   AUTHORS' CONCLUSIONS: The results from the four trials to date demonstrate no advantage to early repair (via open or endovascular surgery) for small AAA (4.0 to 5.5 cm) and suggest that 'best care' for these patients favours surveillance. Furthermore, the more recent trials focused on the efficacy of endovascular aneurysm repair and still failed to show benefit. Thus, both open and endovascular repair of small AAAs are not supported by currently available evidence.

Comparison of outcomes after transcatheter aortic valve implantation following home versus non-home discharge.

As more patients undergo transcatheter aortic valve implantation (TAVI), knowledge of 1-year mortality and associated factors becomes increasingly important. After other cardiac procedures, discharge location has been shown to be associated with 1-year mortality. We examined outcomes of TAVI patients discharged home vs an extended care facility (ECF). All TAVI patients from January 1, 2012, to December 31, 2017, were evaluated. Cox proportional hazard regression models with cubic splines were used to estimate the adjusted effect of discharge to ECF on 1-year mortality. A total of 957 (85.6%) patients discharged home were compared to 160 (14.3%) discharged to ECF. On univariate analysis, patients discharged home were younger and had a lower Society of Thoracic Surgeons Predicted Risk of Mortality, higher albumin, and fewer vascular complications and strokes. Patients discharged to ECF had a higher 30-day mortality (3.8% vs. 0.5%, P = 0.001) and 1-year mortality (25.7% vs. 8.3%, P < 0.001). Cox proportional hazard regression models showed increased risk of 1-year mortality for patients discharged to ECF. In conclusion, patients discharged to ECF had a higher 30-day and 1-year mortality. The strongest predictor of 1-year mortality was discharge to ECF. Society of Thoracic Surgeons Predicted Risk of Mortality score was not a predictor of 1-year mortality.

Postoperative atrial fibrillation: Sex-specific characteristics and effect on survival.

BACKGROUND: We sought to fill important gaps in the existing evidence regarding new-onset atrial fibrillation (AF) after coronary artery bypass graft surgery (CABG) by comparing the incidence, characteristics, and effect on long-term survival between men and women. METHODS: Nine thousand two hundred three consecutive patients without preoperative AF underwent isolated CABG from 2002 to 2010 at 3 US academic medical centers and 1 high-volume specialty cardiac hospital. Detailed data on CABG AF events detected via continuous in-hospital electrocardiogram/telemetry monitoring were supplemented with Society of Thoracic Surgeons data, and survival data, censored at October 31, 2011, using a copy of the Social Security Death Master File archived before state-owned data were removed (November 1, 2011). RESULTS: Propensity-adjusted (Society of Thoracic Surgeons-recognized risk factors) incidence of post-CABG AF was 31.5% overall, 32.8% in men, and 27.4% in women. Over the 9-year study period, women had a significantly lower risk of post-CABG AF (absolute difference, -5.3% [95% confidence interval (CI), -10.5% to -0.6%]), and significantly shorter first (-2.9 hours; 95% CI, -5.8 to 0.0), and longest (-4.3 hours; 95% CI, -8.3 to -0.3) AF duration. Post-CABG AF was associated with significantly increased risk of long-term mortality (overall hazard ratio [HR], 1.56; 95% CI, 1.45-1.67; men HR, 1.57; 95% CI, 1.49-1.65; women HR, 1.54; 95% CI, 1.14-2.07). CONCLUSIONS: In our study, women had lower adjusted risk of post-CABG AF and experienced shorter episodes. The adjusted risk of long-term mortality was 56% greater among patients who developed post-CABG AF compared with those who did not. The effect of post-CABG AF on long-term survival did not differ between the sexes.

Preoperative ß-Blockers as a Coronary Surgery Quality Metric: The Lack of Evidence of Efficacy.

BACKGROUND: Two quality measures used in public reporting and value-based payment programs require ß-blockers be administered less than 24 hours before isolated coronary artery bypass graft surgery to prevent atrial fibrillation and mortality. Questions have arisen about continued use of these measures. METHODS: We conducted a systematic search for randomized controlled trials (RCTs) examining the impact of preoperative ß-blockers on atrial fibrillation or mortality after isolated coronary artery bypass graft surgery to determine what evidence of efficacy supports the measures. RESULTS: We identified 11 RCTs. All continued ß-blockers postoperatively, making it unfeasible to separate the benefits of preoperative vs postoperative administration. Meta-analysis was precluded by methodologic variation in ß-blocker utilized, timing and dosage, and supplemental and comparison treatments. Of the eight comparisons of ß-blockers/ß-blocker plus digoxin versus placebo (n = 826 patients), six showed significant reductions in atrial fibrillation/supraventricular arrhythmias. Of the three comparisons (n = 444) of ß-blockers versus amiodarone, two found no significant difference in atrial fibrillation; the third showed significantly lower incidence with amiodarone. One RCT compared ß-blocker plus amiodarone versus each of those drugs separately; the combination reduced atrial fibrillation significantly better than the ß-blocker alone, but not amiodarone alone. Seven RCTs reported short-term mortality, but this outcome was too rare and the sample sizes too small to provide any meaningful comparisons. CONCLUSIONS: Existing RCT evidence does not support the structure of quality measures that require ß-blocker administration specifically within 24 hours before coronary artery bypass graft surgery to prevent postoperative atrial fibrillation or short-term mortality. Quality measures should be revised to align with the evidence, and further studies conducted to determine optimal timing and method of prophylaxis.

Postcoronary Artery Bypass Graft Atrial Fibrillation Event Count and Survival: Differences by Sex.

BACKGROUND: New-onset atrial fibrillation (AF) after coronary artery bypass graft surgery (CABG) is associated with poor outcomes, but data on the effects of its characteristics are lacking and conflicting. We examined the effect number of post-CABG AF events has on long-term mortality risk, and whether this is sex dependent. METHODS: Routinely collected Society of Thoracic Surgeons (STS) data were supplemented with details on new-onset post-CABG AF (detected in-hospital by continuous electrocardiogram/telemetry monitoring) and long-term survival for 9203 consecutive patients with isolated-CABG (2002-2010). With the use of Cox regression, we determined the propensity-adjusted (STS-recognized risk factors) effect of number of AF events on survival, testing for effect modification by sex and controlling for AF duration. RESULTS: AF occurred in 739 women (29.4%) and 2157 men (32.3%) (P < .001). Adjusted results showed 2 or more AF events significantly (P < .001) increased 5-year mortality risk, independently of total AF duration. However, mortality risk differed between the sexes (P < .001): women with 2 AF episodes had the greatest increase (hazard ratio [HR] = 2.98; 95% confidence interval [CI], 1.43-4.83; versus women without AF), followed by women and men with 4 or more AF events (HR = 2.76 [95% CI, 1.27-4.55] and HR = 2.73 [95% CI, 2.30-3.19], respectively). A single post-CABG AF episode was not associated with increased mortality risk. CONCLUSIONS: Both men and women who experienced 2 or more post-CABG AF episodes showed increased risk of 5-year mortality, independent of total AF duration. Although men's risk increased as the number of AF events increased, women's risk peaked at 2 AF events. Future research needs to determine whether this divergence stems from differences in treatment/management or underlying biology.

Prospective Evaluation of a Blood Transfusion Protocol for Patients Undergoing Cardiac Operations.

BACKGROUND: The Society of Thoracic Surgeons clinical practice guidelines recommend the creation of an interdisciplinary blood management team to implement protocols for improved blood transfusion practices. We report our center's prospective evaluation of a blood transfusion protocol. METHODS: An interdisciplinary blood management team developed protocols for transfusion of packed red blood cells, fresh frozen plasma, platelets, and cryoprecipitate. The protocols were prospectively evaluated by tracking transfusions administered to consecutive patients undergoing cardiac operations, and the primary outcome of interest was the mean number of adjusted units of blood product transfused per patient. Protocol implementation phases were separated by washout phases to control for a potential Hawthorne effect associated with protocol implementation. Protocol compliance was also assessed. RESULTS: A total of 1441 patients underwent cardiac operations during the 16-month study period. Although there was no statistically significant reduction in transfusions with an unadjusted analysis, there was a significant trend toward a reduction of the mean adjusted total units transfused per patient over the course of the study period (P < .001). The mean adjusted total units transfused per patient were significantly less during the second washout phase (2.8 units; 95% confidence interval [CI], 2.3-3.3) and second protocol phase (2.8 units; 95% CI, 2.32-3.27) compared with the initial baseline survey phase (3.6 units, 95% CI, 3.1-4.1; P < .05 for both comparisons). Only 55.2% of all units were transfused in compliance to the implemented protocols: platelets, 46.8%; cryoprecipitate, 32.1%; packed red blood cells, 60.7%; and fresh frozen plasma, 53.6%. CONCLUSIONS: During a prospective evaluation of blood transfusion protocols, a risk-adjusted analysis demonstrated a reduction in transfusions despite poor protocol compliance.

Lower Survival After Coronary Artery Bypass in Patients Who Had Atrial Fibrillation Missed by Widely Used Definitions.

OBJECTIVE: To investigate the impact of limiting the definition of post-coronary artery bypass graft (CABG) atrial fibrillation (AF) to AF/flutter requiring treatment-as in the Society of Thoracic Surgeons' (STS) database- on the association with survival. PATIENTS AND METHODS: We assessed in-hospital incidence of post-CABG AF in 7110 consecutive isolated patients with CABG without preoperative AF at 4 hospitals (January 1, 2004 to December 31, 2010). Patients with ≥1 episode of post-CABG AF detected via continuous in-hospital electrocardiogram (ECG)/telemetry monitoring documented by physicians were assigned to the following: Group 1, identified as having post-CABG AF in STS data and Group 2, not identified as having post-CABG AF in STS data. Patients without documented post-CABG AF constituted Group 3. Survival was compared via a Cox model, adjusted for STS risk of mortality and accounting for site differences. RESULTS: Over 7 years' follow-up, 16.0% (295 of 1841) of Group 1, 18.7% (79 of 422) of Group 2, and 7.9% (382 of 4847) of Group 3 died. Group 2 had a significantly greater adjusted risk of death than both Group 1 (hazard ratio [HR]: 1.16; 95% confidence interval [CI], 1.02 to 1.33) and Group 3 (HR: 1.94; 95% CI, 1.69 to 2.22). CONCLUSIONS: The statistically significant 16% higher risk of death for patients with AF post-CABG missed vs captured in STS data suggests treatment and postdischarge management should be investigated for differences. The historical misclassification of "missed" patients as experiencing no AF in the STS data weakens the ability to observe differences in risk between patients with and without post-CABG AF. Therefore, STS data should not be used for research examining post-CABG AF.

Comparison of Frequency of Vascular Complications With Ultrasound-Guided Versus Fluroscopic Roadmap-Guided Femoral Arterial Access in Patients Who Underwent Transcatheter Aortic Valve Implantation.

To compare outcomes of ultrasound guidance (USG) versus fluoroscopy roadmap guidance (FG) angiography for femoral artery access in patients who underwent transfemoral (TF) transcatheter aortic valve implantation (TAVI) to determine whether routine USG use was associated with fewer vascular complications. Vascular complications are the most frequent procedural adverse events associated with TAVI. USG may provide a decreased rate of access site complications during vascular access compared with FG. Patients who underwent TF TAVI between July 2012 and July 2017 were reviewed and outcomes were compared. Vascular complications were categorized by Valve Academic Research Consortium-2 criteria and analyzed by a multivariable logistic regression adjusting for potential confounding risk factors including age, gender, body mass index, peripheral vascular disease, Society of Thoracic Surgeons score and sheath to femoral artery ratio. Of the 612 TAVI patients treated, 380 (63.1%) were performed using USG for access. Routine use of USG began in March 2015 and increased over time. Vascular complications occurred in 63 (10.3%) patients and decreased from 20% to 3.9% during the study period. There were fewer vascular complications with USG versus FG (7.9% vs 14.2%, p = 0.014). After adjusting for potential confounding risk factors that included newer valve systems, smaller sheath sizes and lower risk patients, there was still a 49% reduction in vascular complications with USG (odds ratio 0.51, 95% confidence interval 0.29 to 0.88, p = 0.02). In conclusion, USG for TF TAVI was associated with reduced vascular access site complications compared with FG access even after accounting for potential confounding risk factors and should be considered for routine use for TF TAVI.

A hospital-randomized controlled trial of a formal quality improvement educational program in rural and small community Texas hospitals: one year results.

OBJECTIVE: To investigate the effectiveness of a quality improvement educational program in rural hospitals. DESIGN: Hospital-randomized controlled trial. PARTICIPANTS: A total of 47 rural and small community hospitals in Texas that had previously received a web-based benchmarking and case-review tool. INTERVENTION: The 47 hospitals were randomized either to receive formal quality improvement educational program or to a control group. The educational program consisted of two 2-day didactic sessions on continuous quality improvement techniques, followed by the design, implementation and reporting of a local quality improvement project, with monthly coaching conference calls and annual follow-up conclaves. MAIN OUTCOME MEASURES: Performance on core measures for community-acquired pneumonia and congestive heart failure were compared between study groups to evaluate the impact of the educational program. RESULTS: No significant differences were observed between the study groups on any measures. Of the 23 hospitals in the intervention group, only 16 completed the didactic program and 6 the full training program. Similar results were obtained when these groups were compared with the control group. CONCLUSIONS: While the observed results suggest no incremental benefit of the quality improvement educational program following implementation of a web-based benchmarking and case-review tool in rural hospitals, given the small number of hospitals that completed the program, it is not conclusive that such programs are ineffective. Further research incorporating supporting infrastructure, such as physician champions, financial incentives and greater involvement of senior leadership, is needed to assess the value of quality improvement educational programs in rural hospitals.

Female-Authored Articles Are More Likely to Include Methods-Trained Authors.

OBJECTIVE: Studies with authors trained in research methods are of higher quality than those without. We examined inclusion of authors with master's or doctoral degrees incorporating advanced research methods training on original research articles in high-impact journals, investigating differences between journals and by first-author sex. METHODS: Using all original research articles from 1 issue of The New England Journal of Medicine (NEJM), Journal of the American Medical Association (JAMA), Annals of Internal Medicine (Annals), and JAMA-Internal Medicine/Archives of Internal Medicine (Archives) every alternate month, February 1994 to October 2016, we assessed the prevalence of articles listing authors with master's/doctoral research degrees and its adjusted associations with time of publication, journal, and first-author sex via multivariable logistic regression models (accounting for number of authors, study type, specialty/topic, and continent and for interactions between journal and time of publication, study type, and continent). RESULTS: Of 3009 articles examined, 84.4% (n=2539) had authors listing research degrees. After adjustment, the prevalence of such articles increased from 1994 to 2016 (P<.001), but patterns differed among journals. Annals and NEJM increased to approximately100% by 2016; JAMA and Archives peaked around 2010 to 2011, then declined. Articles with female first authors were more likely to list authors with research degrees (adjusted odds ratio=1.66; 95% CI, 1.29-2.13; P<.001). CONCLUSION: The prevalence of original research articles listing authors trained in research methods in high-impact journals increased significantly but is now declining at some journals, with potential effects on quality. The greater prevalence among female first-authored articles suggests possible sex differences in structuring/crediting research teams or subconscious sex bias during review.

Impact of Mitral Stenosis on Survival in Patients Undergoing Isolated Transcatheter Aortic Valve Implantation.

This study was performed to investigate the prevalence and impact on survival of baseline mitral stenosis (MS) in patients who underwent transcatheter aortic valve implantation (TAVI) due to the presence of severe symptomatic aortic stenosis. This retrospective study included 928 consecutive patients with severe, symptomatic aortic stenosis who underwent TAVI in 2 institutions, from January 2012 to August 2016. Mean follow-up was 40.8 ± 13.9 months. Based on the mean mitral gradient (MMG) at baseline, 3 groups were identified: MMG <5 mm Hg (n = 737, 81.7%); MMG ≥5 and <10 mm Hg (n = 147, 16.3%); MMG ≥10 mm Hg (n = 17, 1.9%). These latter were more frequently women, with a smaller body surface area, a higher prevalence of atrial fibrillation, chronic obstructive pulmonary disease, and previous history of coronary-artery bypass graft/percutaneous coronary intervention. At baseline, patients with MMG ≥10 mm Hg compared with ≥5 and <10 mm Hg and <5 mm Hg patients had a lower mitral valve area (2.4 ± 0.94 vs 2.1 ± 0.86 vs 1.5 ± 0.44 cm2), a lower prevalence of MR ≥2+ (5.9% vs 28.6% and 15.6%, p <0.0001), a higher prevalence of severe mitral annular calcium (70.6% vs 45.6% and 13.0%, p <0.0001) and a higher systolic pulmonary arterial pressure (50.6 ± 12.1 vs 47.2 ± 14.5 and 41.6 ± 14.4, p <0.0001). Despite the low prevalence of MMG ≥10 mm Hg, these patients had higher 5-year mortality compared with the other groups (adjusted hazard ratio 2.91, 95% confidence interval 1.17 to 7.20, p = 0.02). In conclusion, severe calcific MS is uncommon in patients who underwent TAVI. Its presence is associated with higher long-term mortality whereas moderate MS is not.

Acute myocardial infarction in hospitalized patients with community-acquired pneumonia.

BACKGROUND: An epidemiological link between respiratory infection and acute myocardial infarction (AMI) has been suggested, and recent data indicate that there is an association between AMI and pneumococcal community-acquired pneumonia (CAP) in hospitalized patients. The objective of this study was to investigate the association of AMI with the severity of pneumonia at hospitalization and clinical failure during hospitalization among patients with CAP. METHODS: An observational, retrospective study involving consecutive patients hospitalized with CAP was performed at the Veterans Hospital of Louisville, Kentucky. Patients admitted to the intensive care unit were defined as having severe CAP. Clinical failure was defined as the development of respiratory failure or shock. AMI was diagnosed on the basis of abnormal troponin levels and electrocardiogram findings. Propensity-adjusted models that controlled for clinical and nonclinical factors were used to investigate the association between AMI and pneumonia severity index and between AMI and clinical failure. RESULTS: Data for a total of 500 patients were studied. At hospital admission, AMI was present in 13 (15%) of 86 patients with severe CAP. During hospitalization, AMI was present in 13 (20%) of 65 patients who experienced clinical failure. Following risk adjustment, significant associations were discovered between AMI and the pneumonia severity index score (modeled with a restricted cubic spline) (P = .05) and between AMI and clinical failure (P = .04). CONCLUSIONS: A combined diagnosis of CAP and AMI is common among hospitalized patients with severe CAP. In cases in which the clinical course of a hospitalized patient with CAP is complicated by clinical failure, AMI should be considered as a possible etiology.