Peak insulin drip rate associated with decreased infections post-solid organ transplant.

Infection and rejection outcomes were retrospectively analyzed in patients following liver transplant and separately following heart transplant with patients being stratified by their severity of immediate postoperative insulin resistance as measured by the peak insulin drip rate that was required to reduce glucose levels. For each group, these peak insulin drip rates were divided into quartiles (Q). In liver transplant patients (n = 207), those in Q4 (highest infusion rate) had significantly fewer infections up to 6 months post-transplant (42.3% vs. 60.0%, p = .036) and borderline fewer rejection episodes (25.0% vs. 40.0%, p = .066) compared to Q1-Q3 patients. To confirm these unexpected results, a subsequent similar analysis in heart transplant (n = 188) patients again showed that Q4 patients had significantly fewer infections up to 6 months (19.1% vs. 53.9%, p < .0001) compared to Q1-Q3 patients. Logistic regression in a subset of 103 cardiac transplant patients showed that the maximum glucose during surgery, prior MI, and hypertension were associated with severe insulin resistance (SIR) status, while the presence of pre-existing diabetes and BMI were not. We hypothesize that patients are who are able to mount a more robust counter-regulatory response that causes the insulin resistance may be healthier and thus able to mount a better response to infections.

Effects of catheter ablation of atrial fibrillation on the biomarker profile.

BACKGROUND: Following catheter ablation for atrial fibrillation (AF), there are dynamic changes in the atrial myocardium associated with damage to and necrosis of atrial tissue and other procedure related changes in rhythm and anticoagulation. Early time-dependent changes in biomarkers of necrosis, inflammation, and coagulation have been reported. This study examines mid-term (4-8 weeks post-ablation) changes in biomarkers and explores their ability to predict AF recurrence at one-year. METHODS: Twenty-seven patients (mean age 65.4 ± 9.7 years, 30% female) undergoing catheter ablation for AF had peripheral venous blood samples obtained at the time of ablation and 4-8 weeks later. All samples were processed to obtain plasma which was frozen for subsequent analysis. Coagulation studies were performed at the Northwestern Special Hemostasis Laboratory: VWF, ADAMTS13, PAI-1, D-dimer, and TAT complexes. A commercial lab analyzed samples for CRP, cystatin C, fibrinogen, galectin, IL-6, MMP-2, myoglobin, NT-proBNP, PAI-1, TIMP-1, TIMP-2, TPA, and VWF. RESULTS: Significant changes were noted with higher levels of ADAMTS13 (p < 0.0001), fibrinogen (p = 0.004), MMP-2 (p = 0.0002), TIMP-2 (p = 0.003), and TPA (p = 0.001) compared to lower levels of TAT (p < 0.0001) and NT-proBNP (p = 0.0001) at follow up post-ablation. One year after ablation, AF had recurred in 11/26 (42%) of patients. None of the biomarker changes predicted the 1-year outcome, and there was no significant association with the use of warfarin versus rivaroxaban. CONCLUSION: In patients undergoing catheter ablation for AF, there were significant changes in pre- vs post-ablation levels of multiple biomarkers. However, these changes were not associated with 1-year outcome of AF recurrence.

Implementation of a direct-to-operating room aortic emergency transfer program: Expedited management of type A aortic dissection.

INTRODUCTION: Type A Aortic Dissection (TAAD) is a surgical emergency with a time-dependent rate of mortality. We hypothesized that a direct-to-operating room (DOR) transfer program for patients with TAAD would reduce time to intervention. METHODS: A DOR program was started at an urban tertiary care hospital in February 2020. We performed a retrospective study of adult patients undergoing treatment for TAAD before (n = 42) and after (n = 84) implementation of DOR. Expected mortality was calculated using the International Registry of Acute Aortic Dissection risk prediction model. RESULTS: Median time from acceptance of transfer from emergency physician to operating room arrival was 1.37 h (82 min) faster in DOR compared to pre-DOR (1.93 h vs 3.30 h, p < 0.001). Median time from arrival to operating room was 1.14 h (72 min) faster after DOR compared to pre-DOR (0.17 h vs 1.31 h, p < 0.001). In-hospital mortality was 16.2% in pre-DOR, with an observed-to-expected (O/E) ratio of 1.03 (p = 0.24) and 12.0% in the DOR group, with an O/E ratio of 0.59 (p < 0.001). CONCLUSION: Creation of a DOR program resulted in decreased time to intervention. This was associated with a decrease in observed-to-expected operative mortality. The transfer of patients with acute type A aortic dissection to centers with direct-to-OR programs may result in decreased time from diagnosis to surgery.

Association Between Caregiver Burden and Patient Recovery After Left Ventricular Assist Device Implantation: Insights From Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support.

INTRODUCTION: After left ventricular assist device (LVAD) implantation, caregivers may experience increasing burden because of new roles and responsibilities. We examined the association between caregiver burden at baseline and patient recovery after long-term LVAD implantation in patients ineligible for heart transplantation. METHODS: Between October 1, 2015, and December 31, 2018, data from 60 patients with a long-term LVAD (age, 60-80 years) and caregivers through 1 postoperative year were analyzed. Caregiver burden was measured using the Oberst Caregiving Burden Scale, a validated instrument used for measuring caregiver burden. Patient recovery post-LVAD implantation was defined by change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) overall summary score and rehospitalizations over 1 year. Multivariable regression models (least-squares for change in KCCQ-12 and Fine-Gray cumulative incidence for rehospitalizations) were used to assess for association with caregiver burden. RESULTS: Patients were 69.4 ± 5.5 years old, 85% men, and 90% White. Over the first year post-LVAD implantation, there was a 32% cumulative probability of rehospitalization; 72% (43/60) of patients had an improvement of ≥5 points in KCCQ-12 scores. Caregivers were 61.2 ± 11.5 years old, 93% women, 81% White, and 85% married. Median Oberst Caregiving Burden Scale Difficulty and Time scores at baseline were 1.13 and 2.27, respectively. Higher caregiver burden was not significantly associated with hospitalizations or change in patient health-related quality of life during the first year post-LVAD implantation. CONCLUSIONS: Higher caregiver burden at baseline was not associated with patient recovery in the first year after LVAD implantation. Understanding the associations between caregiver burden and patient outcomes after LVAD implantation is important as excessive caregiver burden is a relative contraindication for LVAD implantation.

Esophageal temperature management during cryoballoon ablation for atrial fibrillation.

INTRODUCTION: Esophageal thermal injury (ETI) is a well-recognized complication of atrial fibrillation (AF) ablation. Previous studies have demonstrated that direct esophageal cooling reduces ETI during radiofrequency AF ablation. The purpose of this study was to evaluate the use of an esophageal warming device to prevent ETI during cryoballoon ablation (CBA) for AF. METHODS: This prospective, double-blinded study enrolled 42 patients with symptomatic AF undergoing CBA. Patients were randomized to the treatment group with esophageal warming (42°C) using recirculated water through a multilumen, silicone tube inserted into the esophagus (EnsoETM®; Attune Medical) (WRM) or the control group with a luminal single-electrode esophageal temperature monitoring probe (LET). Patients underwent upper endoscopy esophagogastroduodenoscopy (EGD) the following day. ETI was classified into four grades. RESULTS: Baseline patient characteristics were similar between groups. Procedural characteristics including number of freezes, total freeze time, early freeze terminations, coldest balloon temperature, procedure duration, posterior wall ablation, and proton pump inhibitor and transesophageal echocardiogram use before procedure were not different between groups. The EGD was completed in 40/42 patients. There was significantly more ETI in the WRM group compared to the LET group (n = 8 [38%] vs. n = 1 [5%], p = 0.02). All ETI lesions were grade 1 (erythema) or 2 (superficial ulceration). Total freeze time in the left inferior pulmonary vein was predictive of ETI (360 vs. 300 s, p = 0.03). CONCLUSION: Use of a luminal heat exchange tube for esophageal warming during CBA for AF was paradoxically associated with a higher risk of ETI.

Valve-sparing versus valve-replacing aortic root replacement in patients with aortic root aneurysm.

BACKGROUND: Valve-sparing aortic root replacement (VSARR) is an alternative to valve-replacing aortic root replacement (VRARR) with valved-conduits based on recent guidelines for clinical practice. This study investigated outcomes of these two procedures in patients with nonstenotic valves. METHODS: Between January 7, 2007 and June 30, 2019, 475 patients with aortic root aneurysm without aortic stenosis underwent VSARR (151) or VRARR (324) techniques. Propensity score-matching (PSM) was used to alleviate confounding. Endpoints were 30-day mortality, 8-year survival and reoperation, aortic regurgitation, and valve gradients. RESULTS: PSM created 69 pairs of patients with a mean age 52 ± 13 years (10.1% Marfan syndrome, 34.8% bicuspid aortic valve). There was no statistically significant difference in major perioperative morbidity or 30-day mortality (0% VSARR vs. 1.4% VRARR; p = 0.316). Overall survival was significantly higher (p = 0.025) in the VSARR group versus the VRARR group (8-year estimates 100% vs. 88.9%, respectively), while freedom from valve reoperation was similar (p = 0.97, 8-year estimates 90.9% vs. 96.7%, respectively). Freedom from > moderate-severe AR was not significantly different (p = 0.08, 8-year estimates 90.0% VSARR group vs. 100% VRARR), but mean valve gradients at last follow-up were better in the VSARR group (5.9 vs. 13.2 mmHg, p < 0.001). CONCLUSIONS: VSARR is a safe operation in patients with aortic root aneurysm and nonstenotic aortic valves in the hands of experienced surgeons. Freedom from reoperation is similar and the mode of aortic valve failure differs between the two groups.

Ankle-brachial index to monitor limb perfusion in patients with femoral venoarterial extracorporeal membrane oxygenation.

BACKGROUND: Limb ischemia is a major complication of femoral venoarterial extracorporeal membrane oxygenation (VA-ECMO). Use of ankle-brachial index (ABI) to monitor limb perfusion in VA-ECMO has not been described. We report our experience monitoring femoral VA-ECMO patients with serial ABI and the relationships between ABI and near infrared spectroscopy (NIRS). METHODS: This is a retrospective single-center review of consecutive adult patients placed on femoral VA-ECMO between January 2019 and October 2019. Data were collected on patients with paired ABI and NIRS values. Relationships between NIRS and ABI of the cannulated (E-NIRS and E-ABI) and non-cannulated legs (N-NIRS and N-ABI) along with the difference between legs (d-NIRS and d-ABI) were determined using Pearson correlation. RESULTS: Overall, 22 patients (mean age 56.5 ± 14.0 years, 72.7% male) were assessed with 295 E-ABI and E-NIRS measurements, and 273 N-ABI and N-NIRS measurements. Mean duration of ECMO support was 129.8 ± 78.3 h. ECMO-mortality was 13.6% and in-hospital mortality was 45.5%. N-ABI and N-NIRS were significantly higher than their ECMO counterparts (ABI mean difference 0.16, 95% confidence interval [CI]: 0.13-0.19, p < .0001; NIRS mean difference 2.51, 95% CI: 1.48-3.54, p < .0001). There was no correlation between E-ABI versus E-NIRS (r = .032, p = .59), N-ABI versus N-NIRS (r = .097, p = .11), or d-NIRS versus d-ABI (r = .11, p = .069). CONCLUSION: ABI is a quantitative metric that may be used to monitor limb perfusion and supplement clinical exams to identify limb ischemia in femorally cannulated VA-ECMO patients. More studies are needed to characterize the significance of ABI in femoral VA-ECMO and its value in identifying limb ischemia in this patient population.

Outcomes of 3-day discharge after elective cardiac surgery.

BACKGROUND: Shorter length of stay (LOS) is a welcome consequence of optimized perioperative care. However, accelerated hospital discharge may have unintended consequences. Before implementing an institutional enhanced recovery after surgery protocol, we evaluated the safety of shorter LOS and compared outcomes of patients with shorter LOS (LOS ≤ 3 days) to those with longer LOS (LOS > 3 days). METHODS: We identified all patients undergoing elective cardiac surgery with cardiopulmonary bypass between July 2004 and June 2017. Transcatheter approaches, ventricular assist devices, transplants, and traumas were excluded. Patients were divided into two cohorts, one with shorter hospitalizations (LOS ≤ 3 days) and one with longer hospitalizations (LOS > 3 days). Propensity score matching (PSM) was performed and differences between the two groups were compared. RESULTS: A total of 5,987 patients (63.0 ± 13.8 years old, 34% female) were identified and 131 (2.2%) patients were LOS ≤ 3 days; median STS Risk score was 1.2 (0.6-2.4). PSM resulted in a total of 478 patients (357 LOS > 3 and 121 LOS ≤ 3 days); median STS Risk score was 0.4 (0.3-0.9). LOS ≤ 3 days had lower rates of postoperative atrial fibrillation (2% vs. 19%; p < .001) and major in-hospital complications (0% vs. 9%; p = .001); however, 30-day readmissions (8% LOS ≤ 3 vs. 6% LOS > 3 days; p = .66) and mortality rates (0% vs. 0%) were comparable between the two groups. CONCLUSION: LOS ≤ 3 days was associated with less postoperative atrial fibrillation and fewer major in-hospital complications. LOS ≤ 3 days was not associated with rehospitalization or mortality. Shorter LOS after elective cardiac surgery appears to be a safe practice with favorable outcomes, especially in low operative risk patients.

Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT): Feasibility of a Pilot Randomized Controlled Trial.

BACKGROUND: Young-adult heart transplant recipients transferring to adult care are at risk for poor health outcomes. We conducted a pilot randomized controlled trial to determine the feasibility of and to test a transition intervention for young adults who underwent heart transplantation as children and then transferred to adult care. METHODS: Participants were randomized to the transition intervention (4 months long, focused on heart-transplant knowledge, self-care, self-advocacy, and social support) or usual care. Self-report questionnaires and medical records data were collected at baseline and 3 and 6 months after the initial adult clinic visit. Longitudinal analyses comparing outcomes over time were performed using generalized estimating equations and linear mixed models. RESULTS: Transfer to adult care was successful and feasible (ie, excellent participation rates). The average patient standard deviation of mean tacrolimus levels was similar over time in both study arms and < 2.5, indicating adequate adherence. There were no between-group or within-group differences in percentage of tacrolimus bioassays within target range (> 50%). Average overall adherence to treatment was similarly good in both groups. Rates of appointment keeping through 6 months after transfer declined over time in both groups. CONCLUSIONS: The feasibility of the study was demonstrated. Our transition intervention did not improve outcomes.

Variations in Criteria and Practices for Heart Transplantation Listing Among Pediatric Transplant Cardiologists.

Ethical issues in pediatric heart transplantation (Htx) include resource allocation, benefit, and burden assessment in high-risk recipients, and informed consent. Practice patterns and decision-making was investigated using an internet survey with 47-multiple choice items and vignette-based questions. Of 43 pediatric Htx cardiologists contacted, 28 (65%) responded. Respondents reported that an overall median 1-month survival of 73% (range 50-100%), 1-year survival of 70% (range 50-85%), 5-year survival of 50% (range 40-85%), and 10-year survival of 50% (range 25-85%) was adequate to offer Htx. Based on vignettes presented, 100% of those surveyed would offer Htx to a straightforward 12-year old with end-stage dilated cardiomyopathy and a 7-year old with hypoplastic left heart syndrome with protein losing enteropathy. Thirty percent of physicians would offer Htx to a patient status post a Fontan procedure with mutliple co-morbidities. Seventy-five percent of physicians would offer Htx despite proven non-adherence. Considerable variability exists in the practice patterns of pediatric heart transplant cardiologists with regards to decision-making while evaluating patients for listing. Disagreements among pediatric Htx cardiologists exist when there are concerns for non-adherence and associated multiple co-morbidities. Further work is needed to understand these variations and develop consensus for pediatric Htx organ allocation.

Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT): Baseline Findings.

Young adult solid organ transplant recipients who transfer from pediatric to adult care experience poor outcomes related to decreased adherence to the medical regimen. Our pilot trial for young adults who had heart transplant (HT) who transfer to adult care tests an intervention focused on increasing HT knowledge, self-management and self-advocacy skills, and enhancing support, as compared to usual care. We report baseline findings between groups regarding (1) patient-level outcomes and (2) components of the intervention. From 3/14 to 9/16, 88 subjects enrolled and randomized to intervention (n = 43) or usual care (n = 45) at six pediatric HT centers. Patient self-report questionnaires and medical records data were collected at baseline, and 3 and 6 months after transfer. For this report, baseline findings (at enrollment and prior to transfer to adult care) were analyzed using Chi-square and t-tests. Level of significance was p < 0.05. Baseline demographics were similar in the intervention and usual care arms: age 21.3 ± 3.2 vs 21.5 ± 3.3 years and female 44% vs 49%, respectively. At baseline, there were no differences between intervention and usual care for use of tacrolimus (70 vs 62%); tacrolimus level (mean ± SD = 6.5 ± 2.3 ng/ml vs 5.6 ± 2.3 ng/ml); average of the within patient standard deviation of the baseline mean tacrolimus levels (1.6 vs 1.3); and adherence to the medical regimen [3.6 ± 0.4 vs 3.5 ± 0.5 (1 = hardly ever to 4 = all of the time)], respectively. At baseline, both groups had a modest amount of HT knowledge, were learning self-management and self-advocacy, and perceived they were adequately supported. Baseline findings indicate that transitioning HT recipients lack essential knowledge about HT and have incomplete self-management and self-advocacy skills.

EVALUATION OF OUTCOMES AND COMPLICATIONS IN PATIENTS WHO EXPERIENCE HYPOGLYCEMIA AFTER CARDIAC SURGERY.

OBJECTIVE: The objective of the study was to elucidate 30-day and long-term outcomes in patients experiencing postoperative hypoglycemia. METHODS: We conducted a retrospective review of patients who underwent cardiac surgery between September 4, 2007, and April 30, 2011, at Northwestern Memorial Hospital who had intensive treatment of hyperglycemia postoperatively. Of 1,325 patients, 215 experienced a hypoglycemic episode (blood glucose <70 mg/dL) within the first 3 postoperative days. A total of 198 were propensity-score (PS) matched to 363 patients without hypoglycemia. The analysis consisted of a comparison of 30-day cardiac outcomes and long-term mortality between those who experienced a hypoglycemic event and those who did not. RESULTS: Between patients who experienced hypoglycemia compared to those that did not, there were no significant differences in mean glucose values while on insulin drips (119.8 ± 33.5 mg/dL vs. 120.9 ± 30.5 mg/dL; P = .69) or subcutaneous insulin (122.0 ± 38.0 mg/dL vs. 127.2 ± 35.5 mg/dL; P = .11) or postoperative surgical complication rates (30-day mortality: 3.5% vs. 1.7%; complications (any): 40% vs. 42%; 30-day re-admissions: 13% vs. 13%; all cardiac complications: 35% vs. 31%; and all infections: 8% vs. 5%). Over an average of 5.1 ± 2.2 years following index surgery, there was higher all-cause mortality among those PS-matched who had experienced hypoglycemia compared to those who had not (log-rank P = .031), primarily due to those (n = 32) experiencing more than one episode of hypoglycemia. CONCLUSION: Postoperative hypoglycemia did not negatively impact immediate surgical complication rates but was associated with a significant risk of increased postoperative morbidity and long-term all-cause mortality in patients experiencing multiple episodes of hypoglycemia. ABBREVIATIONS: BG = blood glucose BMI = body mass index CARD = Cardiovascular Research Database HR = hazard rate PS = propensity score.

Targeted Anticoagulation for Atrial Fibrillation Guided by Continuous Rhythm Assessment With an Insertable Cardiac Monitor: The Rhythm Evaluation for Anticoagulation With Continuous Monitoring (REACT.COM) Pilot Study.

INTRODUCTION: Chronic anticoagulation is recommended for patients with AF and additional stroke risk factors, even during long periods of sinus rhythm. Continuous rhythm assessment with an insertable cardiac monitor (ICM) and use of rapid onset novel oral anticoagulants (NOACs) allow for targeted anticoagulation only around an AF episode, potentially reducing bleeding complications without compromising stroke risk. METHODS: This multicenter, single-arm study enrolled patients on NOAC with nonpermanent AF and CHADS2 score 1 or 2. After a 60-day run-in with no AF episodes ≥ 1 hour, NOACs were discontinued but reinitiated for 30 days following any AF episode ≥ 1 hour diagnosed through daily ICM transmissions. Major endpoints included time on NOAC, stroke, and bleeding. RESULTS: Among 59 enrollees, 75% were male, age 67 ± 8 years, 76% paroxysmal AF, 69% had prior AF ablation, and mean CHADS2 score 1.3 ± 0.5. Over 466 ± 131 mean days of follow-up there were 24,004 ICM transmissions with a compliance rate of 98.7%. A total of 35 AF episodes ≥ 1 hour occurred in 18 (31%) patients, resulting in a total time on NOAC of 1,472 days. This represents a 94% reduction in the time on NOAC compared to chronic anticoagulation. There were three traumatic bleeds (all on aspirin), three potential transient ischemic attacks (all on aspirin with CHADS2 score of 1), and no strokes or deaths. CONCLUSIONS: A targeted strategy of ICM-guided intermittent NOAC administration is feasible. A large-scale trial is necessary to evaluate the safety of this approach.

Moderate Sedation Reduces Lab Time Compared to General Anesthesia during Cryoballoon Ablation for AF Without Compromising Safety or Long-Term Efficacy.

BACKGROUND: Cryoballoon ablation (CBA) for paroxysmal atrial fibrillation (pAF) can be performed under general anesthesia (GA) or moderate sedation (MS). Our objective was to compare the effectiveness, safety, procedure duration, and time spent in the electrophysiology (EP) laboratory for CBA performed under GA and MS. METHODS: Patients undergoing a first CBA for pAF were identified. Patients received either GA administered by an anesthesiologist or MS with midazolam and fentanyl administered by EP laboratory staff. Total time in laboratory (sum of procedure and nonprocedure time); fluoroscopy time; freedom from documented AF, atrial flutter, and atrial tachycardia (FFAF); acute pulmonary vein isolation (PVI) rate; and 30-day complication rate were assessed. RESULTS: A total of 55 patients received GA and 119 patients received MS. PVI success rate was 100% in GA and 98.1% in MS (P = 0.04). Total laboratory time was longer for GA (280.4 ± 54.1 minutes vs 245.5 ± 54.7 minutes; P < 0.001), related to longer nonprocedure time (92.2 ± 28.8 minutes GA vs 71.0 ± 30.0 minutes MS; P < 0.001), but not procedure time (188.3 ± 49.3 minutes GA vs 174.5 ± 50.2 minutes MS; P = 0.09). FFAF was not significantly different over a median follow-up duration of 0.9 (interquartile range 0.4-1.9) years (61.8% GA vs 63.0% MS; log-rank P = 0.90). There was no significant difference in complication rate. CONCLUSION: Compared to GA, MS during CBA for pAF was independently associated with shorter total EP laboratory time without compromising FFAF or complication rates.

Concomitant atrial fibrillation surgery for people undergoing cardiac surgery.

BACKGROUND: People with atrial fibrillation (AF) often undergo cardiac surgery for other underlying reasons and are frequently offered concomitant AF surgery to reduce the frequency of short- and long-term AF and improve short- and long-term outcomes. OBJECTIVES: To assess the effects of concomitant AF surgery among people with AF who are undergoing cardiac surgery on short-term and long-term (12 months or greater) health-related outcomes, health-related quality of life, and costs. SEARCH METHODS: Starting from the year when the first "maze" AF surgery was reported (1987), we searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library (March 2016), MEDLINE Ovid (March 2016), Embase Ovid (March 2016), Web of Science (March 2016), the Database of Abstracts of Reviews of Effects (DARE, April 2015), and Health Technology Assessment Database (HTA, March 2016). We searched trial registers in April 2016. We used no language restrictions. SELECTION CRITERIA: We included randomised controlled trials evaluating the effect of any concomitant AF surgery compared with no AF surgery among adults with preoperative AF, regardless of symptoms, who were undergoing cardiac surgery for another indication. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies and extracted data. We evaluated the risk of bias using the Cochrane 'Risk of bias' tool. We included outcome data on all-cause and cardiovascular-specific mortality, freedom from atrial fibrillation, flutter, or tachycardia off antiarrhythmic medications, as measured by patient electrocardiographic monitoring greater than three months after the procedure, procedural safety, 30-day rehospitalisation, need for post-discharge direct current cardioversion, health-related quality of life, and direct costs. We calculated risk ratios (RR) for dichotomous data with 95% confidence intervals (CI) using a fixed-effect model when heterogeneity was low (I² ≤ 50%) and random-effects model when heterogeneity was high (I² > 50%). We evaluated the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework to create a 'Summary of findings' table. MAIN RESULTS: We found 34 reports of 22 trials (1899 participants) with five additional ongoing studies and three studies awaiting classification. All included studies were assessed as having high risk of bias across at least one domain. The effect of concomitant AF surgery on all-cause mortality was uncertain when compared with no concomitant AF surgery (7.0% versus 6.6%, RR 1.14, 95% CI 0.81 to 1.59, I² = 0%, 20 trials, 1829 participants, low-quality evidence), but the intervention increased freedom from atrial fibrillation, atrial flutter, or atrial tachycardia off antiarrhythmic medications > three months (51.0% versus 24.1%, RR 2.04, 95% CI 1.63 to 2.55, I² = 0%, eight trials, 649 participants, moderate-quality evidence). The effect of concomitant AF surgery on 30-day mortality was uncertain (2.3% versus 3.1%, RR 1.25 95% CI 0.71 to 2.20, I² = 0%, 18 trials, 1566 participants, low-quality evidence), but the intervention increased the risk of permanent pacemaker implantation (6.0% versus 4.1%, RR 1.69, 95% CI 1.12 to 2.54, I² = 0%, 18 trials, 1726 participants, moderate-quality evidence). Investigator-defined adverse events, including but limited to, need for surgical re-exploration or mediastinitis, were not routinely reported but were not different between the two groups (other adverse events: 24.8% versus 23.6%, RR 1.07, 95% CI 0.85 to 1.34, I² = 45%, nine trials, 858 participants), but the quality of this evidence was very low. AUTHORS' CONCLUSIONS: For patients with AF undergoing cardiac surgery, there is moderate-quality evidence that concomitant AF surgery approximately doubles the risk of freedom from atrial fibrillation, atrial flutter, or atrial tachycardia off anti-arrhythmic drugs while increasing the risk of permanent pacemaker implantation. The effects on mortality are uncertain. Future, high-quality and adequately powered trials will likely affect the confidence on the effect estimates of AF surgery on clinical outcomes.

Identification of prolapsing mitral valve scallops by a three-dimensional multiplanar reconstruction method.

BACKGROUND: The objectives of this study were twofold: to assess the diagnostic utility of three-dimensional (3D) multiplanar reconstruction (MPR) in identifying prolapsing mitral valve (MV) scallops, and (2) to compare two-dimensional (2D) transthoracic echocardiography (TTE) and 3DMPR to (2D) transesophageal echocardiography (TEE) approaches among patients with mitral valve prolapse (MVP). METHODS: Fifty-five patients with MVP who underwent MV repair or replacement were retrospectively analyzed using 3 types of echocardiographic studies (2DTEE, 2DTTE, 3DMPR). The operative (OR) findings were considered the gold standard. RESULTS: When 3DMPR was combined with 2DTTE, the agreement with the OR findings was moderately strong for the A2 scallop (P < 0.001) and strong for the A3 scallop (P = 0.001), entire anterior leaflet (P < 0.001), P2 scallop (P < 0.001) and the entire posterior leaflet (P < 0.001). In comparison to the OR findings, 2DTEE demonstrated moderately strong agreement for the A2 scallop (P = 0.010) and the entire anterior leaflet (P < 0.001), and strong agreement for the P2 scallop (P < 0.001) and entire posterior leaflet (P < 0.001). CONCLUSIONS: Three-dimensional MPR should be added to the armamentarium of complementary echo techniques in the evaluation of MVP. There is increased benefit in combining 3DMPR with 2DTTE findings as part of the preoperative evaluation of patients with MVP.

Visualization and dynamics of multidimensional health-related quality-of-life-adjusted overall survival: a new analytic approach.

BACKGROUND: Vesnarinone Trial (VesT) was a three-armed, placebo-controlled, randomized clinical trial designed to study the effects of 30 mg or 60 mg/day vesnarinone. Certain contradictory results involving patient health-related quality-of-life (HRQOL) and overall survival (OS) have made a definitive and unified conclusion difficult. METHODS: To reconcile these findings, we have focused on the HRQOL-adjusted OS, commonly known as quality-adjusted life years (QALYs). Currently, analyses of QALYs incorporate a single HRQOL subscale. However, the VesT HRQOL instrument had two subscales: physical (PHYS) and emotional (EMOT). We have developed new ways to visualize and compare EMOT- and PHYS-adjusted OS. RESULTS: In each VesT arm, there was an increased probability of superior EMOT-adjusted OS, compared to PHYS-adjusted OS. The magnitude of these findings was comparable across trial arms. Despite inferior survival and superior EMOT and PHYS scores, the 60-mg/day arm presents similar EMOT- and PHYS-adjusted OS compared to the placebo arm. CONCLUSIONS: We have provided a fresh perspective on the complex interactions between multiple HRQOL dimensions and OS. These novel methods address the burgeoning need for robust information on the interplay between OS and HRQOL from a patient, clinical care and public policy perspective.

Examination of implementation of intravenous and subcutaneous insulin protocols and glycemic control in heart transplant patients.

OBJECTIVE: Perioperative glycemic management is particularly challenging in heart transplant (HT) patients who are on high-dose steroids and subject to surgical stress. The objective of the study was to examine the efficacy and safety of perioperative insulin administration in HT patients with and without diabetes. METHODS: Medical records of 71 HT patients from June 1, 2005 to July 31, 2009 whose hyperglycemia was managed by our Glucose Management Service (GMS) were analyzed for up to 1 year after HT. Their daily blood glucose (BG) averages on intravenous (i.v.) insulin drips and subcutaneous (s.q.) insulin, hypoglycemia rates, reasons for hypoglycemia, and deviations from insulin protocols were analyzed. RESULTS: Daily BG averages between diabetic (DM) and nondiabetic (nonDM) patients were not significantly different while on the drip but were significantly different for first 5 days on s.q. (P<.05). The daily insulin glargine doses were similar. No patients developed severe hypoglycemia (BG ≤40 mg/dL) while on drip, and only 2.8% experienced hypoglycemia on s.q. Among 40 episodes of moderate hypoglycemia while on drip, 15 had nurse deviations from protocol prior to the episode. Posttransition day fasting glucose was at goal (mean 124.7 ± 35.4 mg/dL); however 39.4% (28/71) of patients received a transition insulin glargine dose that was different from the amount indicated by protocol. The likelihood of developing moderate hypoglycemia on s.q. was associated with the glargine dose used at the time of transition (odds ratio [OR] 1.03, P = .034). CONCLUSION: Inpatient insulin protocols implemented by a GMS are successful in obtaining glycemic control with minimal side effects in patients with and without diabetes, even when they are on a high-dose steroid regimen.

Association of Patient Reported Outcomes With Caregiver Burden in Older Patients With Advanced Heart Failure: Insights From the SUSTAIN-IT Study.

BACKGROUND: Caregivers of patients with advanced heart failure may experience burden in providing care, but whether changes in patient health status are associated with caregiver burden is unknown. METHODS: This observational study included older patients (60-80 years old) receiving advanced surgical heart failure therapies and their caregivers at 13 US sites. Patient health status was assessed using the 12-item Kansas City Cardiomyopathy Questionnaire (range, 0-100; higher scores are better). Caregiver burden was assessed using the Oberst Caregiving Burden Scale, which measures time on task (OCBS-time) and task difficulty (OCBS-difficulty; range, 1-5; lower scores are better). Measurements occurred before surgery and 12 months after in 3 advanced heart failure cohorts: patients receiving long-term left ventricular assist device support; heart transplantation with pretransplant left ventricular assist device support; and heart transplantation without pretransplant left ventricular assist device support. Multivariable linear regression was used to identify predictors of change in OCBS-time and OCBS-difficulty at 12 months. RESULTS: Of 162 caregivers, the mean age was 61.0±9.4 years, 139 (86%) were female, and 140 (86%) were the patient's spouse. At 12 months, 99 (61.1%) caregivers experienced improved OCBS-time, and 61 (37.7%) experienced improved OCBS-difficulty (versus no change or worse OCBS). A 10-point higher baseline 12-item Kansas City Cardiomyopathy Questionnaire predicted lower 12-month OCBS-time (ß=-0.09 [95% CI, -0.14 to -0.03]; P<0.001) and OCBS-difficulty (ß=-0.08 [95% CI, -0.12 to -0.05]; P<0.001). Each 10-point improvement in the 12-item Kansas City Cardiomyopathy Questionnaire predicted lower 12-month OCBS-time (ß=-0.07 [95% CI, -0.12 to -0.03]; P=0.002) and OCBS-difficulty (ß=-0.09 [95% CI, -0.12 to -0.06]; P<0.001). CONCLUSIONS: Among survivors at 12 months, baseline and change in patient health status were associated with subsequent caregiver time on task and task difficulty in dyads receiving advanced heart failure surgical therapies, highlighting the potential for serial 12-item Kansas City Cardiomyopathy Questionnaire assessments to identify caregivers at risk of increased burden. REGISTRATION: URL: https://www.clinicaltrials.gov; unique identifier: NCT02568930.

A comparison of quality-adjusted life years in older adults after heart transplantation versus long-term mechanical support: Findings from the SUSTAIN-IT study.

BACKGROUND: The quality-adjusted life year (QALY) measures disease burden and treatment, combining overall survival and health-related quality of life (HRQOL). We estimated QALYs in 3 groups of older patients (60-80 years) with heart failure (HF) who underwent heart transplantation (HT, with pre-transplant mechanical circulatory support [HT MCS] or HT without pre-transplant MCS [HT Non-MCS]) or long-term MCS (destination therapy). We also identified factors associated with gains in QALYs through 24 months follow-up. METHODS: Of 393 eligible patients enrolled (10/1/15-12/31/18) at 13 U.S. sites, 161 underwent HT (n = 68 HT MCS, n = 93 HT Non-MCS) and 144 underwent long-term MCS. Survival and HRQOL data were collected through 24 months. QALY health utilities were based on patient self-report of EQ-5D-3L dimensions. Mean-restricted QALYs were compared among groups using generalized linear models. RESULTS: For the entire cohort, mean age in years closest to surgery was 67 (standard deviation, SD: 4.7), 78% were male, and 83% were White. By 18 months post-surgery, sustained significant differences in adjusted average ± SD QALYs emerged across groups, with the HT Non-MCS group having the highest average QALYs (24-month window: HT Non-MCS = 22.58 ± 1.1, HT MCS = 19.53 ± 1.33, Long-term MCS = 19.49 ± 1.3, p = 0.003). At 24 months post-operatively, a lower gain in QALYs was associated with HT MCS, long-term MCS, a lower pre-operative LVEF, NYHA class III or IV before surgery, and an ischemic or other etiology of HF. CONCLUSIONS: Determination of QALYs may provide important information for policy makers and clinicians to consider regarding benefits of HT and long-term MCS as treatment options for older patients with HF.