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.

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 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.

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.

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.

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.

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.

Clinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Aortic Valves by Four-Dimensional Computed Tomography.

BACKGROUND: The incidence of leaflet thrombosis after transcatheter aortic valve replacement (TAVR) with active surveillance by four-dimensional computed tomography (4DCT) ranges from 7% to 14%. The incidence of leaflet thrombosis when 4DCT is performed for clinical and echocardiographic indications is unknown. METHODS: All patients with prior TAVR or surgical aortic valve replacement (SAVR) who underwent evaluation between October 2015 and January 2017 at our institution and had clinical or echocardiographic indications of leaflet thrombosis were evaluated by 4DCT. Indications for 4DCT by echocardiography included (1) interval increase in mean gradient of 10 mm Hg or more, (2) interval decrease in ejection fraction of 10% or more, (3) thrombus seen on transthoracic echocardiography, (4) persistent or increasing paravalvular leak, or (5) valve dehiscence or thickened leaflets seen on transthoracic echocardiography. Clinical indicators were (1) stroke, (2) transient ischemic attack, or (3) new or worsening heart failure. RESULTS: During the study period, 612 patients underwent TAVR, and 101 patients (55 TAVR; 46 SAVR) met the criteria for 4DCT imaging. Leaflet thrombosis was seen in 17 of 55 TAVR patients (30.9%) and 15 of 46 SAVR patients (32.6%). Follow-up imaging with 4DCT after treatment with anticoagulation showed improvement or resolution in thrombus burden and leaflet excursion in all TAVR patients and in two-thirds of SAVR patients. CONCLUSIONS: One-third of patients with clinical or echocardiographic indications suggestive of leaflet thrombosis were found to have evidence of leaflet thrombosis using 4DCT. This allowed tailored anticoagulation therapy with resolution of the thrombus in most patients and avoiding unnecessary anticoagulation in the remaining two-thirds of patients.

Albumin Is Predictive of 1-Year Mortality After Transcatheter Aortic Valve Replacement.

BACKGROUND: A validated model for predicting 1-year outcomes after transcatheter aortic valve replacement (TAVR) does not exist. TAVR-specific risk models may benefit from frailty markers, and sarcopenia may represent an objective frailty marker. This study assessed the predictive ability of sarcopenia and frailty markers on 1-year mortality after TAVR. METHODS: We evaluated 470 patients undergoing TAVR at a single center. Frailty was assessed using four markers: gait speed, hand grip strength, serum albumin, and Katz activities of daily living. Sarcopenia was measured as the cross-sectional psoas muscle area on pre-TAVR computed tomography. Performance of four models incorporating The Society of Thoracic Surgeons Predicted Risk of Mortality, frailty, or sarcopenia metrics, or both, for predicting 1-year mortality was assessed with area under the curve, Hosmer-Lemeshow statistics, and calibration plots. RESULTS: A total of 63 deaths (13.4%) deaths occurred by 1 year. The Society of Thoracic Surgeons Predicted Risk of Mortality alone was poorly predictive of 1-year mortality (area under the curve, 0.52; 95% confidence interval, 0.42 to 0.68). Only the model including sarcopenia and all frailty markers (area under the curve, 0.61; 95% confidence interval, 0.53 to 0.68) significantly improved predictive ability compared with The Society of Thoracic Surgeons Predicted Risk of Mortality alone (p = 0.05). Albumin was the only frailty marker significantly associated with increased risk for 1-year mortality (p = 0.03). Psoas muscle area, as a surrogate for sarcopenia, was not significantly associated with increased risk for 1-year mortality. CONCLUSIONS: Most of the commonly used pre-TAVR risk assessments are poorly predictive of 1-year mortality. Albumin was the only frailty marker that was associated with higher mortality. Future studies should investigate whether optimization of nutritional status can improve outcomes after TAVR.

Novel renal biomarker evaluation for early detection of acute kidney injury after transcatheter aortic valve implantation.

Acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI) is associated with increased morbidity and mortality. The biomarkers neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule-1 (KIM-1), and interleukin-18 (IL-18) are predictive of AKI after cardiac surgery, but there is little data regarding these biomarkers after TAVI. We evaluated the associations between NGAL, KIM-1, and IL-18 levels and the incidence and severity of AKI and changes in serum creatinine after TAVI. This was a prospective pilot study of 66 TAVI cases. Urinary biomarkers were measured at baseline and at 2, 4, and 12 hours after TAVI. Demographics, procedural features, and renal function until discharge were compared between patients with and without subsequent AKI. Seventeen patients (25.8%) developed AKI postoperatively (stage 1, n = 14; stage 2, n = 1; stage 3, n = 2). There were no significant differences in unadjusted mean NGAL, KIM-1, and IL-18 levels between patients with and without AKI at 2, 4, and 12 hours following surgery. After adjusting for the Society of Thoracic Surgeons risk of mortality, this study of three urinary biomarkers showed no association with AKI or creatinine after TAVI. Ongoing efforts to predict and modify the risk of AKI after TAVI remain challenging.

Predictors and outcome of conversion to cardiac surgery during transcatheter aortic valve implantation.

OBJECTIVES: Due to increasing clinical experience with transcatheter aortic valve implantation (TAVI) procedures, sophisticated imaging and advanced device technology, TAVI complication rates are low; however, patients requiring conversion to surgery are confronted with an increased mortality risk. In this retrospective study, we evaluated the predictors for conversion and the outcomes of these patients. METHODS: We analysed the records of all patients undergoing TAVI in our centre from 2011 to 2016 and focused on cases that required conversion to sternotomy. We investigated reasons and risk factors for conversion as well as 30-day and 1-year outcomes. RESULTS: During the study period, 32 (2.1%) of 1775 patients undergoing TAVI required immediate conversion to sternotomy. Annular rupture (5 of 32; 16%), device embolization (9 of 32; 28%) and pericardial tamponade (15 of 32; 47%) were the most common reasons for conversion. Usage of a self-expandable valve showed to be the only predictor for conversion (odds ratio 0.38, 95% confidence interval 0.16-0.90; P = 0.03). Survival at 30 days and 1 year was 56% and 41%, respectively. Patients who survived 30 days after conversion showed higher preoperative ejection fraction, shorter duration of surgery and shorter perfusion time. CONCLUSIONS: In this high-volume, single-centre experience, conversion to sternotomy during TAVI occurred in about 2%, with annular rupture, device embolization and pericardial tamponade being the most common causes. Complications requiring conversion showed to be unpredictable. However, in view of these life-threatening complications, the 30-day survival rate exceeding 50% emphasizes the importance of an experienced and well-attuned heart team providing immediate access to surgical bailout procedures.

Epidemiology of new-onset atrial fibrillation following coronary artery bypass graft surgery.

OBJECTIVES: Postoperative atrial fibrillation (AF) following coronary artery bypass graft surgery (CABG) is significantly associated with reduced survival, but poor characterisation and inconsistent definitions present barriers to developing effective prophylaxis and management. We sought to address this knowledge gap. METHODS: From 2002 to 2010, 11 239 consecutive patients without AF underwent isolated CABG at five sites. Clinical data collected for the Society of Thoracic Surgeons (STS) Database were augmented with details on AF detected via continuous in-hospital ECG/telemetry monitoring to assess new-onset post-CABG AF (adjusted for STS risk of mortality); time to first AF; durations of first and longest AF episodes; total in-hospital time in AF; number of in-hospital AF episodes; operative mortality; stroke; discharge in AF; and length of stay (LOS). RESULTS: Unadjusted incidence of new-onset post-CABG AF was 29.5%. Risk-adjusted incidence was 33.1% and varied little over time (P=0.139). Among 3312 patients with post-CABG AF, adjusted median time to first AF was 52 (IQR: 48-55) hours; mean (SD) duration of first and longest events were 7.2 (5.3,9.1) and 13.1 (10.4,15.9) hours, respectively, and adjusted median total time in AF was 22 (IQR: 18-26) hours. Adjusted rates of operative mortality, stroke and discharge in AF did not vary significantly over time (P=0.156, P=0.965 and P=0.347, respectively). LOS varied (P=0.035), but in no discernible pattern. CONCLUSIONS: Each year, ~800 000 people undergo CABG worldwide; >264 000 will develop post-CABG AF. Onset is typically 2-3 days post-CABG and episodes last, on average, several hours. Effective prophylaxis and management is urgently needed to reduce associated risks of adverse outcomes.

Efficacy and effectiveness of on- versus off-pump coronary artery bypass grafting: A meta-analysis of mortality and survival.

BACKGROUND: Despite many studies comparing on- versus off-pump coronary artery bypass graft (CABG), there is no consensus as to whether one of these techniques offers patients better outcomes. METHODS: We searched PubMed from inception to June 30, 2015, and identified additional studies from bibliographies of meta-analyses and reviews. We identified 42 randomized controlled trials (RCTs) and 31 rigorously adjusted observational studies (controlling for the Society of Thoracic Surgeons-recognized risk factors for mortality) reporting mortality for off-pump versus on-pump CABG at specified time points. Trial data were extracted independently by 2 researchers using a standardized form. Differences in probability of mortality (DPM) were estimated for the RCTs and observational studies separately and combined, for time points ranging from 30 days to 10 years. RESULTS: RCT-only data showed no significant differences at any time point, whereas observational-only data and the combined analysis showed short-term mortality favored off-pump CABG (n = 1.2 million patients; 36 RCTs, 26 observational studies; DPM [95% confidence interval (CI)], -44.8% [-45.4%, -43.8%]) but that at 5 years it was associated with significantly greater mortality (n = 60,405 patients; 3 RCTs, 5 observational studies; DPM [95% CI], 10.0% [5.0%, 15.0%]). At 10 years, only observational data were available, and off-pump CABG showed significantly greater mortality (DPM [95% CI], 14.0% [11.0%, 17.0%]). CONCLUSIONS: Evidence from RCTs showed no differences between the techniques, whereas rigorously adjusted observational studies (with >1.1 million patients) and the combined analysis indicated that off-pump CABG offers lower short-term mortality but poorer long-term survival. These results suggest that, in real-world settings, greater operative safety with off-pump CABG comes at the expense of lasting survival gains.