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.

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.

First-in-Human Study of the Saranas Early Bird Bleed Monitoring System for the Detection of Endovascular Procedure-Related Bleeding Events.

OBJECTIVES: To evaluate the safety and accuracy of the Early Bird Bleed Monitoring System (EBBMS; Saranas) for the detection of access-site related bleeds in humans undergoing endovascular procedures. BACKGROUND: Bleeding complications after endovascular procedures are frequent and associated with poor prognosis. The EBBMS is a novel technology designed to detect in real time the onset, progression, and severity of internal bleeds. METHODS: The EBBMS was used during and after endovascular procedures, either as a venous or arterial access sheath. The primary endpoint was the level of agreement in bleed detection between the Saranas EBBMS and postprocedural computed tomography. RESULTS: From August 2018 to December 2018, a total of 60 patients from five United States sites were enrolled and underwent elective endovascular procedures (transcatheter aortic valve replacement [67%], percutaneous coronary intervention [13%], percutaneous ventricular assist device [8%], balloon aortic valvuloplasty [7%], transcatheter mitral valve repair/replacement [4%], and endovascular aneurysmal repair [2%]). The EBBMS detected the absence of bleeds in 21 patients (35%) and bleeds in 39 patients (65%), with bleeding severity level 1 in 20 patients (33%), level 2 in 15 patients (25%), and level 3 in 4 patients (7%). Bleeding detection occurred during the procedure in 31% of patients and post procedure in 69% of patients. The level of agreement between the EBBMS and computed tomography scan was high (Cohen's kappa=0.84). No device-related complications were reported. CONCLUSIONS: The EBBMS was safe across a variety of endovascular procedures and detected bleeding events with a high level of agreement with postprocedural computed tomography scan.

Pump Position Impacts HeartMate II Left Ventricular Assist Device Thrombosis.

The PREVENtion of HeartMate II pump Thrombosis through clinical management (PREVENT) study was a multicenter, prospective investigation to evaluate the rate of pump thrombosis (PT) with adoption of a uniform set of surgical and medical practices for left ventricular assist device implantation. We sought to quantify pump position at baseline and retrospectively define a pump position associated with poor clinical outcomes. Chest x-rays at baseline were prospectively obtained per protocol. Pump pocket depth, inflow cannula (IC) angle relative to the pump, and IC angle relative to the vertical were measured. Pumps falling in the tail-ends of the IC angle and pump pocket depth distributions were categorized as having an extreme pump position within the PREVENT study. Patients with extreme pump position had a significantly higher risk of confirmed and suspected PT, hemolysis, and elevated lactate dehydrogenase. In a multivariable analysis of survival free of confirmed PT, extreme pump position was an independent risk factor (hazard ratio = 3.6; 95% confidence interval = 1.5-8.9; p = 0.006) when adjusting for differences in pump speed and anticoagulation level. Our analysis shows that HeartMate II pump position at implant can significantly impact event-free survival and the incidence of adverse events at 6 months.

Effects of socioeconomic status on clinical outcomes with ventricular assist devices.

BACKGROUND: Lower socioeconomic status (SES) is a known risk factor for worse outcomes after major cardiovascular interventions. Furthermore, individuals with lower SES face barriers to evaluation for advanced heart failure therapies, including ventricular assist device (VAD) implantation. HYPOTHESIS: Examination of the effects of individual determinants of SES on VAD outcomes will show similar survival benefit in patients with lower compared with higher SES. METHODS: All VAD implants at the University of Florida from January 2008 to December 2015 were reviewed. Patient-level determinants of SES included place of residence, education level, marital status, insurance status, and financial resources stratified by percent federal poverty level. Survival or transplantation at 1 year, 30-day readmission, implant length of stay (LOS), and an aggregate of VAD-related complications were assessed in univariate fashion and multivariable regression modeling. RESULTS: A total of 111 patients were included (mean age at the time of implant 57.6 years, 82.8% men). More than half received destination therapy. At 1 year, 78.3% were alive on device support or had undergone successful transplantation. There were no differences in survival, 30-day readmission, or aggregate VAD complications by the SES category. Although patients with lower levels of education had longer LOS in univariate analysis, on multivariable ordinal regression modeling, this relationship was no longer seen. CONCLUSIONS: Patients with lower SES receive the same survival benefit from VAD implantation and are not more likely to have 30-day readmissions, complications of device support, or prolonged implant LOS. Therefore, VAD implantation should not be withheld based on these parameters alone.

Ventricular Assist Device Patients Have Different Clinical Outcomes and Altered Patterns of Bleeding with Intracranial Hemorrhage.

Intracranial hemorrhage (ICH) is one of the most feared complications of left ventricular assist device (LVAD) support. However, outcomes in this group have not been well described. We therefore sought to examine clinical outcomes in this patient population in comparison to those with heart failure (HF) and no LVAD, as well as those without HF or LVAD. The National Inpatient Sample database, years 2002-2012, was queried to classify patients into 3 groups: any ICH (group 1), any HF with any ICH (group 2), and any LVAD with any ICH (group 3). Clinical outcomes, hemorrhage type, neurosurgical intervention rates, and hospital factors were collected and analyzed. Group 1 consisted of 419,264 patients, group 2 had 41,186, and group 3 had 118 patients. Group 3 patients were more likely to be in large, academic medical centers, with longer length of stay and higher hospital charges. Inpatient mortality was highest in this group at 39%; however, 46.2% were ultimately discharged to home. Patients in group 3 were more likely to have a subarachnoid or intracerebral hemorrhage versus a subdural or epidural hemorrhage. Neurosurgical intervention rates did not differ between the groups. Although LVAD patients with ICH have worse clinical outcomes, the majority survived their event and nearly half were able to be discharged home. Left ventricular assist device patients also have a distinct pattern of bleeding with ICH. Additional study is required to understand risk factors for the development of ICH in this population and ideal management strategies.

The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue.

OBJECTIVES: The COMMENCE trial was conducted to evaluate the safety and effectiveness of a novel bioprosthetic tissue for surgical aortic valve replacement (AVR). METHODS: Patients underwent clinically indicated surgical AVR with the Carpentier-Edwards PERIMOUNT™ Magna Ease™ aortic valve with RESILIA™ tissue (Model 11000A) in a prospective, multinational, multicentre (n = 27), single-arm, FDA Investigational Device Exemption trial. Events were adjudicated by an independent Clinical Events Committee; echocardiograms were analysed by an independent Core Laboratory. RESULTS: Between January 2013 and February 2016, 689 patients received the study valve. Mean age was 67.0 ± 11.6 years; 71.8% were male; 26.3% were New York Heart Association Class III/IV. Mean STS PROM was 2.0 ± 1.8 (0.3-17.5). Isolated AVR was performed in 59.1% of patients; others had additional concomitant procedures, usually CABG. Thirty-day outcomes for all patients included all-cause mortality 1.2%, thromboembolism 2.2%, bleeding 0.9%, major paravalvular leak 0.1% and permanent pacemaker implantation 4.7%. Median intensive care unit and hospital length of stay were 2 (range: 0.2-66) and 7 days (3.0-121.0), respectively. At 2 years, New York Heart Association class improved in 65.7%, effective orifice area was 1.6 ± 0.5 cm2; mean gradient was 10.1 ± 4.3 mmHg; and paravalvular leak was none/trivial in 94.5%, mild in 4.9%, moderate in 0.5% and severe in 0.0%. One-year actuarial freedom from all-cause mortality for isolated AVR and for all patients was 98.2% and 97.6%, respectively. Two-year actuarial freedom from mortality in these groups was 95.3% and 94.3%, respectively. CONCLUSIONS: These data demonstrate excellent early safety and effectiveness of aortic valve replacement with a novel bioprosthetic tissue (RESILIA™). CLINICAL TRIAL REGISTRATION: clinicaltrials.gov: NCT01757665.

Perfusion Index: An Indicator of Success During Endoscopic Thoracic Sympathectomy for Hyperhidrosis.

BACKGROUND: Endoscopic thoracic sympathectomy (ETS) is indicated for refractory hyperhidrosis. The pulse oximetry-derived perfusion index (PI) quantifies pulsatile blood flow at the oximeter. Thoracic sympathectomy increases blood flow; thus we postulate it will reliably increase PI. We evaluated the ipsilateral finger PI as a predictor of successful sympathectomy during ETS. METHODS: After institutional review board approval and informed consent, 100 adult patients undergoing bilateral ETS were studied. Finger and earlobe pulse oximetry probes were placed. Hemodynamic variables and PI were continuously monitored. PI data were collected before and every minute after sympathectomy for 5 minutes and then at 10 minutes. We defined a successful sympathectomy by at least a 50% increase of the PI on the ipsilateral arm. A repeated measures analysis of variance was conducted to determine overall model significance (p ≤ 0.05). RESULTS: Left sympathectomy was associated with a mean 240% increase in PI (p < 0.0001) during the first consecutive 10 minutes, whereas the right side exhibited a mean 236% increase in PI (p < 0.0001). Statistically significant differences were observed between the mean baseline PI value ± the standard error of the mean and time intervals (1, 2, 3, 4, 5, and 10 minutes after baseline) on both the left and right sides for all time intervals. The hemodynamics remained constant throughout the study period. All patients had postoperative resolution of their hyperhidrosis symptoms. CONCLUSIONS: In patients with hyperhidrosis of the upper extremities, intraoperative PI derived from an ipsilateral finger pulse oximeter is an intraoperative marker for successful thoracic sympathectomy.

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.

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.

Comparison of periprocedural and mid-term stroke rates and outcomes between surgical aortic valve replacement and transcatheter aortic valve replacement patients.

BACKGROUND: We compared stroke occurrence and outcomes between Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR), both periprocedural and at follow-up. METHODS: From March 2012 to December 2014, 391 consecutive patients underwent TAVR (N.=290) or isolated SAVR (N.=101), concomitantly. Patients' data were prospectively collected. RESULTS: TAVR patients had more comorbidities. One (0.34%) TIA and 9 (3.11%) strokes occurred in-hospital following TAVR, but no cerebrovascular event occurred after SAVR (P=0.11). One stroke (0.99%) and one TIA (0.99%) were detected in SAVR group within 30 days. Among TAVR patients, one (0.75%) stroke at 6 months, 2 (1.9%) strokes and 2 (1.9%) TIAs at 12 months were diagnosed. Kaplan-Meier analysis revealed that 96% and 99% 12-month CVA free survival following TAVR and SAVR, respectively (P=0.67). Preoperative mean trans-aortic valve systolic pressure gradient higher than 40 mmHg remained as risk factor for stroke in TAVR patients only, OR: 4.48 (CI: 1.2-16.54, P=0.02). One intraoperative death, and 5 (4 with CVA) in-hospital deaths occurred after TAVR; whereas only one patient died in SAVR group (P=0.49). Thirty-day mortality was 3.8% (11/290) for TAVR and 0.99% (1/101) for SAVR patients. SAVR patients' survival was 99% at 6 months, 97.9% at 12, and 96.4% at 24 months, whereas survival in TAVR was 97.5% at 6, 92% at 12, and 73.6% at 24 months (HR: 8.43 (CI: 2.47-28.73), P<0.001). CONCLUSIONS: Even with significant differences in patients' baseline characteristics; in-hospital and mid-term stroke rates are not significantly higher following TAVR than SAVR. Although periprocedural stroke is not uncommon in TAVR, mid-term stroke rate is low.

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).

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.

National treatment practices in the management of infectious intracranial aneurysms and infective endocarditis.

INTRODUCTION: There is an absence of widely accepted guidelines for the management of infectious intracranial aneurysms (IIAs) owing to a dearth of high-quality evidence in the literature. OBJECTIVE: To better define the incidence of IIAs, treatment practices, and patient outcomes by performing a Nationwide Inpatient Sample (NIS) database query. METHODS: We queried the NIS database from 2002 to 2011 for all patients with the primary diagnosis of infectious endocarditis (IE), subarachnoid hemorrhage (SAH), or unruptured cerebral aneurysm by ICD-9-CM codes. ICD-9 procedure codes were used to identify patients undergoing neurosurgical or cardiothoracic procedures. RESULTS: The query identified 393 patients with primary diagnosis of IE, SAH or unruptured cerebral aneurysm treated during 2002-2011. The mean age of the patients was 53.5 years; 244 (62%) were male. The majority of patients presented with SAH (361; 91.9%). Only 73 (18.6%) patients underwent neurosurgical coiling or clipping for IIA. Of patients undergoing a neurosurgical procedure, 65 had SAH (constituting only 18% of patients with SAH) and 8 had unruptured aneurysms (constituting only 25% patients with unruptured aneurysms). Cardiac procedures were performed in only 72/393 patients (18.3%) patients. Only 67 (18.6%) of the patients with SAH and 5 (15.6%) with unruptured aneurysms underwent a cardiac corrective surgical procedure. Mortality was significantly higher in those patients managed conservatively (26.7%) than in those who underwent clipping or embolization (15.1%; p<0.001). CONCLUSIONS: In this NIS database study, the majority of patients with IIAs were managed non-operatively, regardless of rupture status. Further investigation is warranted to standardize the management of these lesions.

A rare case of classical Hodgkin's lymphoma in the setting of a newly diagnosed left atrial myxoma.

We report a rare case of left atrial myxoma with concomitant classical Hodgkin's lymphoma in a 36-year-old woman with a non-significant medical history and 4 months of progressively worsening palpitations, dyspnoea on exertion, chest discomfort and fatigue. Outpatient echocardiography revealed functional mitral valve stenosis as a result of a large left atrial cardiac mass. Preoperative thoracic imaging revealed an anterior mediastinal mass with associated lymphadenopathy. The patient underwent successful resection of the anterior mediastinal mass and left atrial mass. Surgical pathology revealed myxoma in the left atrium and classical Hodgkin's lymphoma in the anterior mediastinum. Thus the patient was diagnosed with early-stage classical Hodgkin's lymphoma. This clinical vignette emphasises the importance of a comprehensive diagnostic evaluation in the setting of a newly discovered atrial tumour.

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.

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.

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.).