Effects of red-cell storage duration on patients undergoing cardiac surgery.

BACKGROUND: Some observational studies have reported that transfusion of red-cell units that have been stored for more than 2 to 3 weeks is associated with serious, even fatal, adverse events. Patients undergoing cardiac surgery may be especially vulnerable to the adverse effects of transfusion. METHODS: We conducted a randomized trial at multiple sites from 2010 to 2014. Participants 12 years of age or older who were undergoing complex cardiac surgery and were likely to undergo transfusion of red cells were randomly assigned to receive leukocyte-reduced red cells stored for 10 days or less (shorter-term storage group) or for 21 days or more (longer-term storage group) for all intraoperative and postoperative transfusions. The primary outcome was the change in Multiple Organ Dysfunction Score (MODS; range, 0 to 24, with higher scores indicating more severe organ dysfunction) from the preoperative score to the highest composite score through day 7 or the time of death or discharge. RESULTS: The median storage time of red-cell units provided to the 1098 participants who received red-cell transfusion was 7 days in the shorter-term storage group and 28 days in the longer-term storage group. The mean change in MODS was an increase of 8.5 and 8.7 points, respectively (95% confidence interval for the difference, -0.6 to 0.3; P=0.44). The 7-day mortality was 2.8% in the shorter-term storage group and 2.0% in the longer-term storage group (P=0.43); 28-day mortality was 4.4% and 5.3%, respectively (P=0.57). Adverse events did not differ significantly between groups except that hyperbilirubinemia was more common in the longer-term storage group. CONCLUSIONS: The duration of red-cell storage was not associated with significant differences in the change in MODS. We did not find that the transfusion of red cells stored for 10 days or less was superior to the transfusion of red cells stored for 21 days or more among patients 12 years of age or older who were undergoing complex cardiac surgery. (Funded by the National Heart, Lung, and Blood Institute; RECESS ClinicalTrials.gov number, NCT00991341.).

Gastrointestinal Bleeding During the Index Hospitalization for Mechanical Circulatory Support Devices Implantation, a Nationwide Perspective.

BACKGROUND: Gastrointestinal bleeding (GIB) is a common adverse event after mechanical circulatory support device implantation. However, the majority of the reported data were obtained from small single-center studies. Our aim was to study the prevalence and predictors of GIB during the index hospitalization of mechanical circulatory support devices implantation using a nationwide database. METHODS: Nationwide inpatient sample (2009-2011) was used to perform a retrospective cross-sectional study. Adult patients with discharge diagnosis codes of congestive heart failure and procedure codes of left-ventricular assist device (LVAD) or intra-aortic balloon pump (IABP) implantation or orthotopic heart transplant (OHT, reference group) were identified. Our outcome was GIB during the index hospitalization when the device was implanted. Predictors that achieved statistical significance on the univariate analysis were included in a multivariable logistic-regression analysis. RESULTS: A total of 87,462 patients were included, 87 % of the patients received an IABP, 6 % received LVAD, and 5 % underwent OHT. Prevalence of GIB was 8, 5, and 3 % among those who had LVAD, IABP implantation, and OHT recipients, respectively (p < 0.001). Patients who underwent LVAD implantation had twofold increase in the prevalence of GIB (OR 2.1, 1.7-2.5, p < 0.001) when using IABP or OHT groups as a reference. This increase in the prevalence was not demonstrated among IABP recipients on a multivariate level. CONCLUSION: Prevalence of GIB was higher among LVAD compared to OHT and IABP recipients and could occur as early as the index admission of the device implantation.

Management of Septic emboli in patients with infectious endocarditis.

BACKGROUND AND AIM: Septic emboli (SE) associated with infectious endocarditis (IE) can result in splenic abscesses and infectious intracranial aneurysms (IIA). We investigated the impact of SE on patient outcomes following surgery for IE. METHOD: From January-2000 to October-2015, all patients with surgical IE (n = 437) were evaluated for incidence and management of SE. RESULTS: Overall SE was found in 46/437 (10.52%) patients (n = 17 spleen, 13 brain, and 16 both). No mortality was seen in the brain emboli groups, but in the splenic abscess group the in-hospital mortality was 8.69% (n = 4); and was associated with Age >35 (OR = 2.63, 1.65-4.20) and congestive heart failure (OR = 14.40, 1.23-168.50). Patients with splenic emboli had excellent mid-term outcome following discharge (100% survival at 4-years). Splenic emboli requiring splenectomy was predicted by a >20 mm valve vegetation (OR = 1.37, 1.056-1.77) and WBC >12000 cells/mm (OR = 5.58, 1.2-26.3). No patient with streptococcus-viridians infection had a nonviable spleen (OR = 0.67, 0.53-0.85). Postoperative acute-kidney-injury was higher in the splenectomy group (45.45% vs 9%) (p = 0.027). There were 6 patients with symptomatic IIAs that required coiling/clipping which was associated with age <30 years, (OR = 6.09, 1.10-33.55). Survival in patients with cerebral emboli decreased to 78% at 3-4 years. Patients with both splenic and brain emboli had a 92% survival rate at 1-year and 77% at 2-4 years. CONCLUSION: Septic emboli is common in endocarditis patients. Patients with high preoperative WBC level and large valve vegetations require CT imaging of the spleen. Both spleen and brain interventions in the setting of IE can be performed safely with excellent early and mid-term outcomes.

Left Ventricular Assist Device and Bariatric Surgery: A Bridge to Heart Transplant by Weight and Waiting Time Reduction.

Obesity poses significant challenges in advanced heart failure patients who otherwise meet criteria for listing for heart transplant. We present a patient who underwent bariatric surgery while on LVAD support that subsequently lost weight and was successfully bridged to heart transplantation.

Acute Kidney Injury After Transcatheter Aortic Valve Replacement.

BACKGROUND: Acute kidney injury (AKI) during transcatheter aortic valve replacement (TAVR) increases morbidity and mortality. In this study, we investigated the incidence and risk factors for AKI in patients undergoing TAVR. METHODS: Two hundred ninety consecutive patients underwent TAVR. Valve Academic Research Consortium (VARC)-I criteria for AKI diagnosis at 72 hours, and VARC-II criteria at seven days were employed. RESULTS: Overall AKI incidence was 24.62% (65/264): 50 patients at 72 hours and 15 patients at seven days. Multivariate logistic regression determined transapical (TA) approach (OR: 4.46 [1.37-7.63]), preprocedural glomerular filtration rate less than 45 mL/min (OR: 3.47 [1.35-14.70]), and blood transfusion (OR: 3.34 [1.58-11.09]) as independent predictors for AKI at 72 hours; and prior coronary artery bypass grafting (OR: 3.02 [1.007-9.09]) and peripheral artery disease (PAD) (OR: 3.53 [1.06-11.62]) for AKI at seven days. In-hospital and 30-day mortality was higher in AKI patients. Non-AKI patients' survival was 93% at six months, 89% at 12 months, and 86% at 24 months, whereas survival in AKI at 72 hours was 66% at 6, 12, and 24 months (HR AKI vs. non-AKI: 3.9 [CI: 2.0-7.6]), and survival in AKI at seven days was 64% at 6, 12, and 24 months, HR: 3.13 (CI: 1.42-6.92). For the 12 dialysis patients survival was 82% at 6, 12, and 24 months. CONCLUSIONS: AKI after TAVR is associated with worse outcomes. Blood transfusion should be administered restrictively in TAVR. Patients with CKD, PAD, prior CABG, and TA approach require close surveillance as they are at risk for AKI through seven days after TAVR. doi: 10.1111/jocs.12768 (J Card Surg 2016;31:416-422).

Operative and Mid-Term Outcomes of Thoracic Aortic Operation in Octogenarians and Beyond.

OBJECTIVES: To study the short and mid-term outcomes of thoracic aortic operations in patients ≥80 years old. METHODS: This is a retrospective chart review of patients ≥80 years old who underwent thoracic aortic operation in our institution between 2006 and 2013. RESULTS: Ninety-eight patients were studied. Fifty-four patients underwent open repair; 41 underwent endovascular repair; and three underwent hybrid repair with aortic arch debranching and subsequent endovascular stent graft. Hospital mortality rate among the entire cohort was 11/98 (11%): 7/54 (13%) for open repair; 2/41 (5%) for endovascular repair; and 2/3 (66%) for hybrid repair. Major adverse events occurred in 23/98 (23%) in the entire cohort: 15/54 (28%) in open repair; 5/41 (12%) in endovascular repair; and 3/3 (100%) in hybrid repair. Mean follow-up was 31 ± 28 months (median 26 months). Two- and five-year survival rates were 57%, and 34% for the open approach and 71%, and 43% for the endovascular approach respectively. CONCLUSIONS: Both open and endovascular thoracic aortic repairs can be performed with favorable mortality and perioperative morbidity in appropriately selected octogenarian patients. doi: 10.1111/jocs.12722 (J Card Surg 2016;31:334-340).

Mesenchymal precursor cells as adjunctive therapy in recipients of contemporary left ventricular assist devices.

BACKGROUND: Allogeneic mesenchymal precursor cells (MPCs) injected during left ventricular assist device (LVAD) implantation may contribute to myocardial recovery. This trial explores the safety and efficacy of this strategy. METHODS AND RESULTS: In this multicenter, double-blind, sham-procedure controlled trial, 30 patients were randomized (2:1) to intramyocardial injection of 25 million MPCs or medium during LVAD implantation. The primary safety end point was incidence of infectious myocarditis, myocardial rupture, neoplasm, hypersensitivity reaction, and immune sensitization (90 days after randomization). Key efficacy end points were functional status and ventricular function while temporarily weaned from LVAD support (90 days after randomization). Patients were followed up until transplant or 12 months after randomization, whichever came first. Mean age was 57.4 (±13.6) years, mean left ventricular ejection fraction was 18.1%, and 66.7% were destination therapy LVADs. No safety events were observed. Successful temporary LVAD weaning was achieved in 50% of MPC and 20% of control patients at 90 days (P=0.24); the posterior probability that MPCs increased the likelihood of successful weaning was 93%. At 90 days, 3 deaths (30%) occurred in control patients, and none occurred in MPC patients. Mean left ventricular ejection fraction after successful wean was 24.0% (MPC=10) and 22.5% (control=2; P=0.56). At 12 months, 30% of MPC patients and 40% of control patients were successfully temporarily weaned from LVAD support (P=0.69), and 6 deaths (30%) occurred in MPC patients. Donor-specific HLA sensitization developed in 2 MPC and 3 control patients and resolved by 12 months. CONCLUSIONS: In this preliminary trial, administration of MPCs appeared to be safe, and there was a potential signal of efficacy. Future studies will evaluate the potential for higher or additional doses to enhance the ability to wean LVAD recipients off support. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01442129.

The Incidence, Predictors and Outcomes of Gastrointestinal Bleeding in Patients with Left Ventricular Assist Device (LVAD).

OBJECTIVES: To evaluate rate, recurrence, and predictors of gastrointestinal bleeding (GIB) and impact of endoscopy in left ventricular assist device (LVAD) patients. METHODS: This is a cohort study of all patients who received the current-generation continuous-flow HeartMate II LVAD from 2005 to 2013 at our institution. Patients were followed up, and GIB events recorded until death, time of heart transplantation, or end of observation. RESULTS: LVAD was implanted in 112 patients (median age 67 years, 88% male). A total of 44 patients (39%) had 74 GIB events occurring at a rate of 42.9 per 100 p-y. Endoscopy was performed in 77% of patients, and GIB source was identified in 57% with upper GIB found in almost two-third of cases. Right ventricular dysfunction and post-LVAD ejection fraction >30% were associated with higher GIB rates. Higher pulsatility index was associated with lower GIB rates. Re-bleeding occurred in 19 (43%) patients at a rate of 62.5 per 100 p-y and was not affected by endoscopic therapy at the index endoscopy. CONCLUSIONS: GIB in LVAD patients is common, occurring primarily in the upper GI tract. Upper endoscopy is the preferred strategy though lower endoscopy is also recommended for a full workup. Endoscopy can identify GIB lesions in about 50% of patients, but re-bleeding is common. Right ventricular dysfunction and post-LVAD ejection fraction >30% are associated with higher GIB rates. Higher pulsatility index is associated with lower GIB rates. Reduction in pump speed is a potential strategy for managing and preventing GIB.

Efficacy and Safety of Recombinant Factor VII as Rescue for Severe Perioperative Bleeding in HeartMate II Recipients.

INTRODUCTION: We aimed to study the efficacy and safety of recombinant factor VIIa (rFVIIa) for management of perioperative bleeding in HeartMate II recipients. MATERIALS AND METHODS: Fifty-seven patients underwent HeartMate II implantation. Sixteen patients received rFVIIa (six intraop, eight early postop, and two both intra- and postop). The effect of rFVIIa on transfusion of blood products as well as the amount of chest tube drainage was used to assess efficacy and 30-day incidence of thromboembolic events was used to assess safety. RESULTS: Patients who received intraoperative rFVIIa had been transfused significantly more blood products prior to rFVIIa administration compared to total amount of intraoperatively transfused blood products in those who did not receive intra-op rFVIIa; however, there were no significant differences in the amount of transfused blood products and chest tube output in the 24-hour postoperative period between the two groups. Postoperative administration of rFVIIa did not have a significant impact on the amount of red blood cell transfusion but there was a trend towards decreased requirement for fresh frozen plasma (mean 2.7 vs. 1.1, p = 0.08), platelet (1.5 vs. 0.7, p = 0.14), and cryoprecipitate (5.3 vs. 1.2, p = 0.09). The hourly rate of chest tube output also decreased significantly from an average of 235 ± 57 mL/hour prior to rFVIIa administration to an average of 98 ± 36 mL/hour in the first four hours after rFVIIa administration (p value = 0.003). There were no 30-day thromboembolic events in those patients who received rFVIIa. CONCLUSIONS: This study supports selective use of rFVIIa in HeartMate II recipients for the management of severe perioperative bleeding.

Factors Related to Pump Thrombosis With the Heartmate II Left Ventricular Assist Device.

BACKGROUND: Recent reports suggested that HeartMate II (HMII) thrombosis rates may be higher in implants after 2011. We characterize events at HMII centers (>100 HMII implants) whose device thrombosis rates are equivalent or lower than reported by INTERMACS. METHODS: Seven centers pooled implants from 2011 through June 2013 to examine pump thrombus and identify characteristics and clinical strategies that potentially mitigate the risk. A total of 666 patients (age 59 ± 13 years; 81% male) were studied (support duration: 13.7 ± 8.3 months, cumulative: 759 patient years). Median target INR was 2.25 (range 2.0 to 2.5), and median pump speed was 9200 rpm (range 8600 to 9600). Pump thrombus was suspected with clinical evidence (e.g., hemolysis, positive ramp test) requiring intervention (e.g., anticoagulation therapy, pump exchange) or patient death. RESULTS: Suspected pump thrombus occurred in 24/666 (3.6%) patients within three months of implant. At six months, 38/666 (5.7%) had suspected pump thrombus including 24 (3.6%) resulting in pump exchange or death. Stroke (hemorrhagic: 0.049, and ischemic: 0.048 events/patient year) and survival (six months: 88 ± 1%; 1 year: 81 ± 2%) were consistent with national averages. Suspected pump thrombus patients were younger (55 ± 13 vs. 59 ± 13, p = 0.046) and had more females (31.6% vs. 18.3%, p = 0.054). There was no difference in indication, etiology of heart failure, or body size. CONCLUSIONS: This analysis demonstrates low HMII thrombus events. Minimization of risk factors by uniform implant techniques and consistent post-op management may reduce device thrombosis. A larger scale multicenter evaluation may better elucidate the difference in thrombus events between centers.

Preoperative prediction of spinal cord ischemia after thoracic endovascular aortic repair.

OBJECTIVE: Spinal cord ischemia (SCI) is a devastating but potentially preventable complication of thoracic endovascular aortic repair (TEVAR). The purpose of this analysis was to determine what factors predict SCI after TEVAR. METHODS: All TEVAR procedures at a single institution were reviewed for patient characteristics, prior aortic repair history, aortic centerline of flow analysis, and procedural characteristics. SCI was defined as any lower extremity neurologic deficit that was not attributable to an intracranial process or peripheral neuropathy. Forty-three patient and procedural variables were evaluated individually for association with SCI. Those with the strongest relationships to SCI (P < .1) were included in a multivariable logistic regression model, and a stepwise variable elimination algorithm was bootstrapped to derive a best subset of predictors from this model. RESULTS: From 2002 to 2013, 741 patients underwent TEVAR for various indications, and 68 (9.2%) developed SCI (permanent: n = 38; 5.1%). Because of the lack of adequate imaging for centerline analysis, 586 patients (any SCI, n = 43; 7.4%) were subsequently analyzed. Patients experiencing SCI after TEVAR were older (SCI, 72 ± 11 years; no SCI, 65 ± 15 years; P < .0001) and had significantly higher rates of multiple cardiovascular risk factors. The stepwise selection procedure identified five variables as the most important predictors of SCI: age (odds ratio [OR] multiplies by 1.3 per 10 years; 95% confidence interval [CI], 0.9-1.8, P = .06), aortic coverage length (OR multiplies by 1.3 per 5 cm; CI, 1.1-1.6; P = .002), chronic obstructive pulmonary disease (OR, 1.9; CI, 0.9-4.1; P = .1), chronic renal insufficiency (creatinine concentration ≥ 1.6 mg/dL; OR, 1.9; CI, 0.8-4.2; P = .1), and hypertension (defined as chart history or medication; OR, 6.4; CI, 2.6-18; P < .0001). A logistic regression model with just these five covariates had excellent discrimination (area under the receiver operating characteristic curve = .83) and calibration (χ(2) = 9.8; P = .28). CONCLUSIONS: This analysis generated a simple model that reliably predicts SCI after TEVAR. This clinical tool can assist decision-making about when to proceed with TEVAR, guide discussions about intervention risk, and help determine when maneuvers to mitigate SCI risk should be implemented.

Percutaneous thoracic endovascular aortic repair is not contraindicated in obese patients.

OBJECTIVE: There are limited data describing the preclose technique with the Perclose ProGlide device (Abbott Vascular, Redwood City, Calif) in percutaneous thoracic endovascular aortic repair (P-TEVAR), particularly in obese patients, in whom use of this technique is thought to be relatively contraindicated. The purpose of this analysis was to describe our experience with P-TEVAR and to compare outcomes in patients with or without obesity. METHODS: All TEVAR procedures at a single institution from 2005 to 2011 were reviewed, and P-TEVAR patients were stratified by body mass index (obesity ≥ 30 kg/m2). Preoperative computed tomography scans were analyzed for access vessel depth, calcification, and morphology. Technical success was defined as the ability to achieve hemostasis and to maintain limb perfusion without the need for common femoral artery exposure or obligate surgical repair of the vessel within a 30-day postoperative period. Generalized estimating equations and stepwise logistic regression were used to develop prediction models of preclose failure. RESULTS: The review identified 536 patients, in whom 355 (66%) P-TEVAR procedures were completed (366 arteries; n = 40 [11%] bilateral). Compared with nonobese patients (n = 264), obese patients (n = 91) were typically younger (59 ± 16 years vs. 66 ± 16 years; P = .0004) and more likely to have renal insufficiency (28% vs. 17%; P = .05) or diabetes mellitus (19% vs. 9%; P = .02). The number of Perclose deployments was similar between groups (P = NS). Mean sheath size (25.4F vs 25.0F; P = .04), access vessel inner diameters (8.5 ± 1.9 mm vs. 7.9 ± 2.0 mm; P = .02), and vessel depth (50 ± 20 mm vs. 30 ± 13 mm; P < .0001) were greater in obese patients. Adjunctive iliac stents were used in 7% of cases (10 [11%] in obese patients vs 16 [6%] in nonobese patients; P = .2). Overall technical success was 92% (92% for nonobese patients vs 93% for obese patients; P = .7). Three patients required subsequent operations for access complications, two obese patients (2%) and one nonobese patient (0.4%) (P = .3). Independent predictors of failure were adjunctive iliac stent (odds ratio [OR], 9.5; 95% confidence interval [CI], 3.3-27.8; P < .0001), more than two Perclose devices (OR, 7.0; 95% CI, 2.3-21; P = .0005), and smaller access vessel diameter to sheath size ratio (OR multiplies by 1.1 for each .01 decrease in ratio; 95% CI, 1.02-1.2; P = .007) (area under the receiver operating characteristic curve = .75). CONCLUSIONS: Obesity is not a contraindication to P-TEVAR. P-TEVAR can be performed safely, despite the need for larger diameter sheaths. However, patients predicted to need adjunctive stenting or possessing smaller access vessel diameter to sheath size ratios are at highest risk of preclose failure with the Perclose ProGlide device, and selective use of this technique is recommended.

Late outcomes of a single-center experience of 400 consecutive thoracic endovascular aortic repairs.

BACKGROUND: In this study, we report the late outcomes of a large, decade-long single-center thoracic endovascular aortic repair experience. METHODS AND RESULTS: A prospectively maintained registry and the electronic medical records of 400 consecutive thoracic endovascular aortic repair performed at a tertiary care center were reviewed. The distribution of pathologies treated included aneurysms (198, 49%), dissections (100, 25%), penetrating ulcers (54, 14%), traumatic transections (25, 6%), and other pathologies (23, 6%). Spinal drains were placed prophylactically in 127 cases (32%) of planned extended aortic coverage. There were no acute surgical conversions. Adjunctive surgical procedures were performed on 94 patients (24%). Subclavian revascularizations were performed selectively in only 15% of zone 0 to 2 deployments. The median length of stay was 5 days (limits, 1 and 79 days). Overall 30-day mortality was 6.5% (elective, 2.6%; urgent, 9.5%; and emergent, 20%). Permanent spinal cord ischemia occurred in 4.5% and stroke in 3%. Kaplan-Meier estimates of survival were 82%, 76%, 68%, and 60% and freedom from secondary intervention was 90%, 86%, 81%, and 78% at 6, 12, 24, and 36 months, respectively. Risk factors for mortality included stroke, urgent/emergent repair, age ≥80 years, general anesthesia, and dissection pathology. CONCLUSIONS: Thoracic endovascular aortic repair may be used to treat a variety of thoracic aortic pathologies with a very low risk of intraoperative conversion. Overall rates of mortality and neurological complications were relatively low but significantly increased in emergent repairs. There appeared to be a substantial number of late deaths, which may represent a combination of poor patient selection and treatment failures.

Elective noncardiac surgery in patients with left ventricular assist devices.

As the number of heart failure patients supported with left ventricular assist devices (LVAD) increases, the frequency of elective, noncardiac surgery in this patient population will similarly rise. We retrospectively analyzed our LVAD patient database and identified six patients who underwent elective, noncardiac surgery while on LVAD support. These cases are discussed, with an emphasis on the anesthetic and perioperative considerations. These patients have an acceptable risk profile for elective surgery and should be treated similarly to their age-matched counterparts not on LVAD support.

Evaluation of Erythropoietin Stimulating Agents (ESA) and Their Effect on Blood Optimization for Cardiac Surgery.

BACKGROUND: Cardiovascular surgeries increase the risk of receiving blood transfusions. Erythropoietin stimulating agents (ESAs) have been used to decrease the transfusion rate. The objective of this study was to evaluate the administration of blood products post-cardiothoracic surgery after receiving ESAs. METHODS: This is a single-center, retrospective cohort study. RESULTS: Between May 2017 to May 2018, 52 adult patients underwent cardiac surgery and received ESAs pre-operatively and/or post-operatively. A total of 35 patients were included in the study and 21 (60%) patients did not require a blood transfusion while 14 (40%) patients required a blood transfusion (p = 0.597). The change in hemoglobin (Hgb = 0.773 g/dL, 1.7 g/dL; p = 0.002) and hematocrit (Hct = 2.31%, 4.3%; p = 0.04) was significantly different in patients who received ESAs alone versus ESAs with blood transfusion. Adverse drug reactions showed no significant difference between groups. CONCLUSIONS: In patients undergoing cardiac surgery, ESAs did not significantly reduce the need for blood transfusion. Future and larger studies are necessary to evaluate the effect of ESAs on blood transfusion.

Early blood biomarkers predict organ injury and resource utilization following complex cardiac surgery.

BACKGROUND: Patients undergoing complex cardiac surgery (thoracic aorta and valve) are at risk for organ failure and increased resource utilization. Neutrophil gelatinase-associated lipocalin (NGAL) has been found to be an early biomarker for renal injury. Multiplex cytokine immunoassays allow the evaluation of the early inflammatory response. We examined the relationship between early biomarker appearance (NGAL and multiplex cytokines) and organ injury and resource utilization. MATERIALS AND METHODS: NGAL and multiplex cytokine immunoassays were performed at baseline, 1, 6, and 24 h following surgery on 38 patients undergoing thoracic aorta and valve operations. The mean age was 65 y with 26 males and 12 females. Acute kidney injury (AKIN definition), pulmonary failure (>24 h ventilation), and intensive care unit and hospital stays were examined. RESULTS: One hour following complex cardiac surgery, the quartile of patients with the greatest IL-6 response had higher serum NGAL levels compared with the lowest quartile (347 versus 145 ng/mL, P=0.002), and 70% of these patients progressed to clinical kidney injury. Six hours following surgery, the quartile of patients with the greatest IL-10 response had higher serum NGAL compared with the lowest quartile (271 versus 160, P =0.04), more pulmonary failure (60% versus 10%, P =0.01), and longer ICU and hospital stays (P =0.001). CONCLUSIONS: Patients with early elevated biomarkers of inflammation exhibited higher NGAL, more pulmonary failure, and greater resource utilization. Earlier identification of patients at risk for organ injury may allow for earlier intervention and reduce resource utilization.

Ventricular Assist Device Implantation and Bariatric Surgery: A Route to Transplantation in Morbidly Obese Patients with End-Stage Heart Failure.

We reviewed our experience of morbidly obese patients with end-stage heart failure that underwent left ventricular assist device (LVAD) implantation. From January 1, 2008 to January 1, 2018, 240 adult LVADs were implanted at our center. We reviewed the cases of patients presenting with end-stage heart failure and morbid obesity (preoperative body mass index [BMI] ≥ 35 kg/m2) who underwent LVAD-alone, and compared that to a group that underwent LVAD and bariatric surgery (laparoscopic sleeve gastrectomy [LSG]) as a means for weight reduction. Demographic characteristics, perioperative details, BMI, and status of transplant candidacy were recorded. Statistical analysis was performed (SPSS version 25) with χ2 analysis, Kaplan-Meier survival analysis, regression analysis, and Student's t-test. Twenty-nine patients met criteria and underwent LVAD implantation. Fifteen patients underwent LVAD-alone. Fourteen patients underwent LVAD + LSG. Both groups showed good survival outcomes, LVAD-alone (88.9 ± 5.9 months) versus LVAD +LSG (96.1 ± 12.4 months) but were not significantly different. However, we did note that more patients in the LVAD + LSG group were bridged to heart transplantation (p < 0.001). LVAD-alone and/or LVAD + LSG are both technically feasible and effective treatment options for the long-term survival of morbidly obese patients with end-stage heart failure. Combining LVAD + LSG can help bridge patients to heart transplantation.

Low operative mortality with implantation of a continuous-flow left ventricular assist device and impact of concurrent cardiac procedures.

BACKGROUND: The objective of this study was to determine the impact of concurrent cardiac procedures (CCP) on patient outcomes after HeartMate II (HMII) left ventricular assist device implantation. METHODS AND RESULTS: Two hundred eighty-one patients underwent implantation of a HMII as a bridge to transplantation from March 2005 to March 2007. One hundred seventy patients had an HMII implanted only, and 81 patients underwent concurrent cardiac procedures in conjunction with HMII implantation (HMII+CCP). Of these, 47 patients had concurrent valvular procedures, 15 patients had simultaneous closure of patent foramen ovale, and 19 patients had other various cardiac procedures. Patients requiring right ventricular assist device support or noncardiac procedures were excluded. Preoperative characteristics were similar for patients with and without concurrent cardiac procedures. Overall 30-day mortality was 5.8% for the HMII group and 11.3% for the HMII+CCP group. Subgroup analysis demonstrated that simultaneous patent foramen ovale closure was not associated with an increased 30-day mortality rate, but concurrent valvular procedures increased the risk to 8.5%. Patients who underwent an aortic valve procedure had a 30-day mortality rate of 25%, higher than for isolated concurrent mitral (0%) or tricuspid repair (3.3%). Survival at 180 days was 87% for HMII alone and 80% for HMII+CCP. The hazard ratio for concurrent cardiac procedures adjusted for baseline parameters was 1.82 (95% CI, 1.07 to 3.10, P=0.026). CONCLUSIONS: There is a low 5.8% operative mortality rate for patients requiring uncomplicated HMII implantation, with no apparent increased risk for concurrent patent foramen ovale closure or mitral or tricuspid repair. However, concurrent aortic valve and other cardiac procedures are associated with significantly decreased perioperative and long-term survival.

Renal and hepatic function improve in advanced heart failure patients during continuous-flow support with the HeartMate II left ventricular assist device.

BACKGROUND: The effects of continuous blood flow and reduced pulsatility on major organ function have not been studied in detail. METHODS AND RESULTS: We evaluated renal (creatinine and blood urea nitrogen) and hepatic (aspartate transaminase, alanine transaminase, and total bilirubin) function in 309 (235 male, 74 female) advanced heart failure patients who had been supported with the HeartMate II continuous-flow left ventricular assist device for bridge to transplantation. To determine whether patients with impaired renal and hepatic function improve over time with continuous-flow left ventricular assist device support or whether there are any detrimental effects in patients with normal organ function, we divided patients into those with above-normal and normal laboratory values before implantation and measured blood chemistry over time during left ventricular assist device support. There were significant improvements over 6 months in all parameters in the above-normal groups, with values in the normal groups remaining in the normal range over time. Mean blood urea nitrogen and serum creatinine in the above-normal groups decreased significantly from 37+/-14 to 23+/-10 mg/dL (P<0.0001) and from 1.8+/-0.4 to 1.4+/-0.8 mg/dL (P<0.01), respectively. There were decreases in aspartate transaminase and alanine transaminase in the above-normal groups from 121+/-206 and 171+/-348 to 36+/-19 and 31+/-22 IU (P<0.001), respectively. Total bilirubin for the above-normal group was 2.1+/-0.9 mg/dL at baseline; after an acute increase at week 1, it decreased to 0.9+/-0.5 mg/dL by 6 months (P<0.0001). Both renal and liver values from patients in the normal groups remained normal during support with the left ventricular assist device. CONCLUSIONS: The HeartMate II continuous-flow left ventricular assist device improves renal and hepatic function in advanced heart failure patients who are being bridged to transplantation, without evidence of detrimental effects from reduced pulsatility over a 6-month time period.

First United States experience of the TX2 Pro-Form thoracic delivery system.

OBJECTIVES: Failure to conform to the arch ("bird-beaking") can lead to endoleak and graft collapse after thoracic endovascular aortic repair. We report the first United States experience with the new TX2 Pro-Form (Cook Inc, Bloomington, Ind), a novel delivery system that became commercially available in October 2009, designed to enhance circumferential apposition of the TX2 thoracic endograft to the arch. METHODS: This was a single-institution retrospective study. Endograft-to-arch conformance was quantitatively analyzed using intraoperative angiograms of consecutive, reverse chronologic cohorts of TX2 Pro-Form, TX2 Z-Trak (prior delivery system; Cook), and Gore TAG (W.L. Gore and Assoc, Flagstaff, Ariz). Only native aortic arch deployments in zones 2 and 3 were included. RESULTS: During a 6-week period, 20 Pro-Form cases were performed, of which 17 patients met inclusion criteria. These were compared with 17 Z-Trak and 17 TAG patients. Endografts were successfully delivered to their intended proximal landing zones in all 51 patients. A higher proportion of dissections were treated in the Z-Trak (65%) and TAG (76%) patients (P = .03), but similar rates of zone 2/3 deployments (P = .30). Despite the mean arch angle being greatest for the Pro-Form patients (90° vs 74° vs 71°, P = .18), the mean separation between the leading endograft edge and the aortic wall along the inner curvature of the arch was significantly less (1.4 vs 4.1 vs 5.7 mm; P = .0002), with complete apposition achieved in 65% of Pro-Form patients (18% Z-Trak, 6% TAG, P < .0001). This resulted in the lowest reduction in aortic luminal diameter at the proximal landing zone (5.5% vs 13.4% vs 19.3%; P = .0006) compared with Z-Trak and TAG. Rates of type Ia endoleak were similar (P = .38). CONCLUSIONS: The Pro-Form delivery system significantly improves endograft conformation to the arch, resulting in minimum bird-beaking even in severely angulated anatomies.