Practice Patterns in Sternal Closure and Evaluation of Adoption of a Novel Sternal Closure Device.

OBJECTIVE: The technique for sternal closure has remained largely unchanged owing to the efficacy, simplicity, and low cost of stainless-steel sternal wires. Despite their ubiquity, several other closure devices designed to address the complications associated with sternal wires such as sternal bleeding and dehiscence have become popular. We have developed a novel sternal closure device that reduces sternal bleeding and dehiscence. This study quantifies the use of currently available sternal closure devices and determines predicted uptake of the novel device. METHODS: An electronic survey, designed to determine practice patterns for sternal closure, was distributed to 70 US cardiac surgeons. The survey included a discrete choice section in which surgeons evaluated relative value of device attributes including cost, ease of emergent sternal reentry, and dehiscence risk. RESULTS: There were 70 surgeons from 30 states who completed the survey. The most frequent means of sternal closure was straight sternal wires (35.8%), followed by straight sternal wires plus figure-of-8 sternal wires (18.1%), double wires (10.9%), plates (10.2%), and other (25%). The relative utilization shifted from sternal wires to sternal plates as the risk for dehiscence increased. The adoption of the novel closure device was estimated at 34.6%. CONCLUSIONS: The standard stainless-steel sternal wire remains the most common means of sternal reapproximation, but its utilization is lower in patients at high risk for sternal dehiscence. Based on this survey, there is acceptance in the community for a novel sternal closure device designed to address the limitations of traditional sternal closure methods.

Mechanical Analysis of a Novel Sternal Closure System in Static Tensile Loading.

The most common means of sternal closure after sternotomy is stainless steel wire cerclage. These wires, while inexpensive and simple in design, are known to be associated with low strength and sternal dehiscence. In this biomechanical analysis, we compare single sternal wires, double sternal wires, and a novel sternal closure device we have designed to mitigate sternal dehiscence. The device uses polymer grommets at the sternal interfaces to distribute load over a large surface area of bone. Samples of each closure device were installed in a bone model and distracted at a rate of 10 mm/min while tensile forces were continuously measured and compared. Single wires generated the lowest stiffness and strength values, followed by the double wires. The novel device demonstrated significantly higher stiffness and strength at all displacements compared with the single and double wires. Clinical use of this device may result in meaningful reduction in complications associated with the use of standard sternal wires such as sternal separation and fracture.

Open Surgical Treatment of Acute and Chronic Pulmonary Embolism.

Acute pulmonary embolism (PE) is a common cause of death and morbidity in the United States and the prevalence of chronic thromboembolic pulmonary hypertension (CTEPH), a possible sequela of PE, has increased during the past decade. The mainstay treatment of CTEPH is open pulmonary endarterectomy, a procedure performed under hypothermic circulatory arrest, which entails endarterectomy of the branch, segmental and subsegmental pulmonary arteries. Acute PE may be similarly be treated with an open embolectomy in certain select circumstances.

Patient factors associated with left ventricular assist device infections: A scoping review.

Infections are widely prevalent in left ventricular assist device (LVAD) recipients and associated with adverse events including mortality and rehospitalizations. Current evidence examining factors associated with infections in this setting predominantly comprises single-center observational data. We performed a scoping review to systematically summarize all existing studies examining patient-related factors associated with infections after LVAD implantation. Studies published between 01/06 and 02/19 were identified through searching 5 bibliographic databases: PubMed, Scopus, EMBASE, CINAHL, and Web of Science Core Collection. Inclusion criteria required examination of patient-related factors associated with infections among recipients of contemporary implantable, continuous flow LVADs. Key study characteristics were extracted by four independent reviewers and current literature described narratively. All analyses took place between February 2019 and May 2021. A total of 31 studies met inclusion criteria. All included studies were observational, and most commonly focused on driveline infections (n = 17). Factors studied most commonly included body composition (n = 8), diabetes and other comorbidities (n = 8), and psychosocial/socio-economic factors (n = 6). Studies were frequently single-center with heterogeneity in definition of infectious outcomes as well as exposure variables. Patient race and sex did not correlate with infection risk. There was no consistent association noted between obesity, diabetes, or psychosocial/socio-economic factors and infections in LVAD recipients. Two studies reported a significant association between malnutrition and hypoalbuminemia and post implant infections. This review summarizes 31 studies that described patient-related factors associated with infection after LVAD implantation. Patient related comorbidities, especially body composition and diabetes, were most commonly evaluated, but were not consistently associated with infections after LVAD implantation.

Non-patient factors associated with infections in LVAD recipients: A scoping review.

BACKGROUND: Infections are the most common complication in recipients of durable left ventricular assist devices (LVAD) and are associated with increased morbidity, mortality, and expenditures. The existing literature examining factors associated with infection in LVAD recipients is limited and principally comprises single-center studies. This scoping review synthesizes all available evidence related to identifying modifiable, non-patient factors associated with infections among LVAD recipients. METHODS: Published studies were identified through searching 5 bibliographic databases: PubMed, Scopus, EMBASE, CINAHL, and Web of Science Core Collection. Inclusion criteria required examination of factors associated with infections among recipients of contemporary, implantable, continuous flow LVADs. Key study characteristics were extracted by 4 independent reviewers and current literature described narratively. The Systems Engineering Initiative for Patient Safety (SEIPS) model was used to develop a taxonomy for non-patient related factors (e.g., tasks, tools, technologies, organization, and environment) associated with infections following LVAD implantation. All analyses took place between February 2019 and May 2021. FINDINGS: A total of 43 studies met inclusion criteria. The majority of included studies were observational (n = 37), single-center (n = 29), from the U.S. (n = 38), and focused on driveline infections (n = 40). Among the 22 evaluated sub-domains of non-patient related factors, only two: increasing center experience and establishing a silicone-skin interface at the driveline exit site, were identified as consistently being associated with a lower risk of infection. CONCLUSION: This review identified 43 studies that described non-patient related factors associated with infection in LVAD recipients. Only two factors were consistently associated with lower infection risk in LVAD recipients: increasing experience and establishing a silicone-skin interface at driveline exit site. The large variability in reporting across multiple studied interventions limited the ability to discern their effectiveness.

Outcomes Following Left Ventricular Assist Device Exchange: Focus on the Impacts of Device Infection.

Hemodynamic support with continuous-flow left ventricular assist device (CF-LVAD) therapy has proven a reliable treatment for advanced heart failure. Although modern LVADs are highly durable, device failure and infection can be resolved with surgical exchange of pump components. In this study, we investigated the incidence and outcomes of LVAD exchange with the HeartMate II and HeartWare HVAD. Data were obtained from 677 patients who underwent CF-LVAD implantation between 2005 and 2016. Patients who underwent a device exchanged were included. The primary outcomes were length of hospital stay and mortality. Of the 677 patients included in this study, 72 (10.6%) required LVAD exchange. Thirty-day and 1-year mortality rates were comparable to primary LVAD implantation: 4.3% vs. 3.49%, p = 0.727 and 20.3% vs. 20.7%, p = 0.989, respectively. Thirty-one patients (4.5%) underwent exchange with ongoing infection. Kaplan-Meier analysis indicated significant differences in survival between groups based on indication for exchange. Patients who underwent exchange after more than 150 days of active infection suffered worse postexchange survival than those who underwent exchanged earlier (P = 0.007). While exchange was required only in 10.6% of patients undergoing LVAD implantation, our results show device exchange may be executed safely and effectively, with long-term outcomes similar to primary LVAD implantation. The indication for device exchange impacts postexchange outcomes, and those exchanged with LVAD infection tend to fare worse than those exchanged for device malfunction or thrombus. Patients who are exchanged with active infection have better postoperative survival if the exchange is performed expeditiously after medical management has failed.

Treatment of HeartMate II Short-to-Shield Patients With an Ungrounded Cable: Indications and Long-Term Outcomes.

Despite modifications and a procedure to externally replace the distal portion of the percutaneous lead, damage to the wiring insulation causing an electrical short to ground, referred to as a short to shield (STS), has become an important factor in the longevity of the HeartMate II left ventricular assist device (LVAD). Device exchange has been the suggested treatment option. The aim of this study was to evaluate the long-term clinical outcomes of patients with an STS supported on an ungrounded cable. A retrospective review of all patients (n = 479) implanted with a HeartMate II at our center between January 2008 and December 2017 was performed. Patients with a documented STS maintained on an ungrounded cable were examined. Patient characteristics, time from device implantation to STS, treatment strategies, and duration of support on an ungrounded cable were summarized. The association between support with an ungrounded cable and clinical outcomes was evaluated. A total of 53 (11% of 479) patients (83% males and 81% destination therapy) with an STS were supported on an ungrounded cable for a median duration of 195 days (range 2 days to 3.3 years). Patients were more active (New York Heart Association [NYHA] p < 0.001, 6 minute walk test [6MWT] p = 0.003) and had a trend toward increased weight gain (p = 0.055) from time of implant to STS. Duration of support before the STS was 1.9 years (range 165 days to 8.6 years). Twenty-two patients were treated directly with an ungrounded cable and 31 patients underwent an external driveline repair and still required an ungrounded cable within 2 days (range 0 days to 1.3 years). During the study period, 38 patients were maintained on an ungrounded cable: 21 patients were ongoing for 299 days (range 114 days to 2.8 years), 11 patients transplanted after 79 days (range 7-295 days), four patients died because of comorbid conditions after 1.6 years (range 141 days to 3.2 years), one patient exchanged for thrombosis after 229 days, and one patient explanted after 279 days. The other 15 patients developed a phase-to-phase electrical short after 51 days (range 2 days to 3.3 years): 14 patients underwent a successful pump exchange and one patient transplanted within 2 days. No patients died because of support with an ungrounded cable or worsening lead damage necessitating device exchange. With extended durations of support, some patients with a HeartMate II LVAD will experience device failure in the form of an STS. Select patients with an STS can be safely supported on an ungrounded cable for several years with close monitoring. This treatment approach should be considered before a device exchange.

Interval analysis of blood filtration efficacy in novel device for autotransfusion in postpartum hemorrhage.

Postpartum haemorrhage (PPH), the leading cause of maternal mortality, is particularly problematic in low resource settings where access to safe blood supplies and definitive medical treatment is limited. We describe the continued development of an autotransfusion device designed to treat PPH by collection, filtration and infusion of maternal blood. Previous study has demonstrated that the device effectively moves blood through a filtration apparatus and removes up to 97% of aerobic bacteria but had poor anaerobic bacteria reduction. In this study, we investigate the filtration efficacy of the device using configurations comprised of three different leukocyte depletion filter designs: the Pall Leukoguard RS leukocyte reduction filter (PLRF), the Haemonetics BPF4™ (BPF4) leukocyte reduction filter, and the Haemonetics SCRC Leukotrap® (SCRC) filter. All configurations performed well with reductions ranging from 49 to 98%. Configurations containing 2 Haemonetics SCRC Leukotrap®filters (configuration 5 and 6) consistently reduced anaerobic bacteria by at least 73%. These results indicate that utilising a combination of SCRC and PLRF filters confers a high level of microbial filtration with improved removal of anaerobic organisms.

Improved Nutrition Status in Patients With Advanced Heart Failure Implanted With a Left Ventricular Assist Device.

BACKGROUND: Left ventricular assist device (LVAD) implantation for advanced heart failure is known to improve survival, functional capacity, and quality of life. Most patients implanted with LVADs suffer from moderate to severe malnutrition and deconditioning due to their advanced disease. The Mini Nutritional Assessment (MNA) and the short form of the survey (MNA-SF) are 2 well-validated clinical tools, previously used to assess patient nutrition status in numerous conditions. Earlier work has demonstrated that low nutrition scores can independently predict mortality in the LVAD population. This study explored changes in MNA scores and other clinical markers following LVAD. METHODS: This retrospective study included 74 patients implanted with LVADs between 2012 and 2017. MNA or MNA-SF along with other clinical data and nutrition indices were assessed during the preoperative workup and reassessed on average 423.9 days post LVAD. Paired-samples t-tests were used to evaluate any changes. RESULTS: Despite an average body mass index of 30.8, 28.3% of patients were classified by MNA as malnourished, and 58.5% were considered at risk prior to LVAD implantation. Post LVAD implantation, MNA scores improved from an average of 19.2-23.0 (P < 0.001), with now only 3.8% classified as malnourished and 45.3% classified as at risk. MNA-SF and prognostic nutritional index also improved significantly. CONCLUSIONS: This study indicates that LVAD implantation is associated with a long-term improvement in nutrition status when compared with the preoperative heart failure state.

Postoperative B-Type Natriuretic Peptide as Predictor for Postoperative Outcomes in Patients Implanted With Left Ventricular Assist Devices.

B-type natriuretic peptide (BNP) is a cardiac neurohormone known to correlate with left ventricular (LV) dilation, decreased contractility, and increased stiffness. Consequently, BNP has been used as a prognostic tool to assess the degree of LV unloading for patients supported by continuous-flow LV assist devices (LVADs). We assessed the prognostic value of changes in BNP in the 2 weeks after LVAD implantation. This retrospective study analyzed laboratory findings and outcomes of 189 LVAD patients. Patients were separated into two groups based on whether serum BNP levels had improved from preoperative levels by postoperative day 14. Group 1 had improvement in BNP levels, whereas group 2 had no improvement or worsening in BNP. There were no significant differences between the groups in age, gender, race, body mass index, or comorbidities. Group 1 had preoperative BNP 1,125 ± 1,078.3 pg/dl and postoperative BNP 440.2 ± 267.7 pg/dl (preoperative minus postoperative [ΔBNP] = -693.09 ± 942.4 pg/dl), whereas group 2 had preoperative BNP 346.0 ± 309.1 pg/dl and postoperative BNP 631.57 ± 483.4 pg/dl (ΔBNP = 289.32 ± 329.7 pg/dl). Postoperative survival in group 2 was significantly worse than in group 1. Rates of right ventricular failure (RVF) were significantly higher in group 2 (group 1: 39%, group 2: 52.7%; p = 0.01). In most patients implanted with a LVAD, BNP improves significantly in the postoperative period as the LV is unloaded. Our results indicate that lack of improvement in postoperative BNP is associated with longer length of stay, increased rates of RVF, and is an independent risk factor for reduced postoperative survival.

Risk stratification with longitudinal neutrophil to lymphocyte ratio assessment after left ventricular assist device implantation.

INTRODUCTION: Inflammatory processes are well-characterized risk factors in cardiovascular disease including advanced heart failure. Previous studies have utilized individual white cell subtypes in risk analysis, and a recent study has focused on the efficacy of the neutrophil-to-lymphocyte ratio in evaluating negative outcomes following left ventricular assist device implantation. To investigate the interaction between the left ventricular assist device and white cell counts, we assessed longitudinal changes in neutrophil-to-lymphocyte ratio following left ventricular assist device implantation. METHODS: This retrospective study included 100 patients who underwent left ventricular assist device implantation between 2012 and 2013. The neutrophil-to-lymphocyte ratio was calculated prior to left ventricular assist device implantation, daily for the first 30 postoperative days, and at the first two postoperative outpatient visits. Preoperative demographic and clinical data were collected for all patients. RESULTS: The mean neutrophil-to-lymphocyte ratio immediately before left ventricular assist device implantation was 5.2 ± 4.9. After surgery, the neutrophil-to-lymphocyte ratio decreased asymptotically, from a peak of 29.2 on postoperative day 1 to 4.1 at the second outpatient visit ( p < 0.001). Lack of improvement in the neutrophil-to-lymphocyte ratio at postoperative day 10 was associated with increased length of stay, right heart failure, and a trend toward worsened survival. CONCLUSION: Our results indicate a significant inflammatory response to implantation of the left ventricular assist device, a known effect. The magnitude of this response may be effectively and easily monitored over time using the neutrophil-to-lymphocyte ratio. In general, approximately 30 days is required for the neutrophil-to-lymphocyte ratio to return to preoperative levels. After several months, the neutrophil-to-lymphocyte ratio improves to below preoperative levels. It is possible that this reduction reflects the reversal of various heart failure-mediated inflammatory processes following left ventricular assist device implantation.

Effect of Vitamin D Level on Clinical Outcomes in Patients Undergoing Left Ventricular Assist Device Implantation.

BACKGROUND: Vitamin D is an important hormone that regulates cardiac myocyte function. Low levels contribute to the development of cardiovascular disease and have been implicated in immune function and the inflammatory cascade. Patients who undergo left ventricular assist device (LVAD) implantation are at risk for driveline infection, stroke, and gastrointestinal (GI) bleeding. We investigated whether serum 25-hydroxy (25-OH) vitamin D levels affect clinical outcomes after LVAD. METHODS: 212 patients who underwent LVAD implantation between 2010 and 2015 were included. We measured preoperative 25-OH vitamin D level and postoperative adverse events during the first year. Vitamin D level was classified into 3 categories: normal (>30 ng/mL), insufficient (20-30 ng/mL), and deficient (<20 ng/mL). Clinical outcomes in both insufficient and deficient categories were compared with the normal category. RESULTS: The odds ratio (OR) of being admitted ≥2 times was 2.46 (95% confidence interval [CI]: 1.067-5.769) for deficiency and 2.5 (95% CI: 0.970-6.443) for insufficiency. The OR of driveline infection was 6.185 (95% CI: 0.80-49.2; P = .07) for insufficiency and 11.467 (95% CI: 1.204-109.26; P = .03) for deficiency. Vitamin D levels were not associated with GI bleeding, length of stay, or stroke. CONCLUSIONS: In patients with LVAD, both deficiency and insufficiency of 25-OH vitamin D levels are independently associated with increased postoperative driveline infection risk and higher rate of readmission. Further trials are needed to confirm whether a repletion regimen could be a promising means of decreasing the risk for these postoperative adverse events.

The neutrophil to lymphocyte ratio in patients supported with extracorporeal membrane oxygenation.

INTRODUCTION: The neutrophil to lymphocyte ratio (NLR) has proven to be a robust predictor of mortality in a wide range of cardiovascular diseases. This study investigated the predictive value of the NLR in patients supported by extracorporeal membrane oxygenation (ECMO) systems. METHODS: This study included 107 patients who underwent ECMO implantation for cardiogenic shock. Median preoperative NLR was used to divide the cohort, with Group 1 NLR <14.2 and Group 2 with NLR ≥14.2. Survival, the primary outcome, was compared between groups. RESULTS: The study cohort was composed of 64 (60%) males with an average age 53.1 ± 14.9 years. Patients in Group 1 had an average NLR of 7.5 ± 3.5 compared to 27.1 ± 19.9 in Group 2. Additionally, those in Group 2 had significantly higher preoperative blood urea nitrogen (BUN) and age. Survival analysis indicated a thirty-day survival of 56.2%, with significantly worsened mortality in patients with NLR greater than 14.2, p=0.047. DISCUSSION: Our study shows the NLR has prognostic value in patients undergoing ECMO implantation. Leukocytes are known contributors to myocardial damage and neutrophil infiltration is associated with damage caused by myocardial ischemia.

Preoperative Nutritional Assessment with the Prognostic Nutrition Index in Patients Undergoing Left Ventricular Assist Device Implantation.

The prognostic nutritional index (PNI) is a simple metric that uses serum albumin and total lymphocyte count to provide a basic indicator for nutritional status. It has recently garnered attention as a prognosticator of outcomes in many types of cancer. We investigated the utility of the PNI as a marker for poor outcomes following left ventricular assist device (LVAD) implantation. Two hundred eighty-eight consecutive patients implanted with continuous-flow LVADs were included. Prognostic nutritional index was calculated for all patients (PNI = [10 × serum albumin {g/dl}] + [0.005 × total lymphocytes {1,000/µl}]). The population was split into two groups based on median PNI; group 1 with PNI <30 and group 2 with PNI ≥30. Mean age was 60.3 years in group 1 and 59.8 years in group 2. There were no significant differences between groups in terms of age, gender, ethnicity, or comorbidities. The mean PNI for the group as a whole was 30.1 ± 4.6, indicating pervasive malnutrition in this group of advanced heart failure patients. Group 1 had significantly longer postoperative length of stay than did group 2 (27.42 ± 19.31 vs. 21.66 ± 15.0 days; p = 0.008). Patients in group 1 also had higher rates of right ventricular failure (37.8% vs. 25.5%; p = 0.025). A multivariate model indicated that PNI less than 30 was associated with a 12.2% reduction in postoperative survival (Hazard Ratio: 0.888; confidence interval [CI]: 0.795-0.993; p = 0.037). Our results suggest that the PNI may be an indicator for worsened outcomes in patients with advanced heart failure. These patients, who often suffer from chronic malnutrition, may experience worsened outcomes because of associated neurohormonal, muscular, and metabolic derangements.

The Sodium Paradox: Dysnatremia and Mortality in Patients Implanted With Extracorporeal Mechanical Circulatory Support Devices.

INTRODUCTION: Dysnatremia, abnormal serum sodium levels, has long been used as a marker for disease progression in heart failure patients. Classically, hyponatremia is associated with increased fluid volume in heart failure and is often a result of neuroendocrine dysfunction and poor cardiac output. Recent studies have noted that dysnatremia and hypernatremia are predictive of worsened outcomes in critical care and renal disease populations. We investigated the relationship between dysnatremia and postoperative outcomes in patients implanted with extracorporeal mechanical circulatory devices. METHODS: A total of 97 patients who underwent implantation with the CentriMag mechanical circulatory assist system were included in this retrospective study. Patients were divided into 2 groups based on preoperative serum sodium level cutoff of 135 mEq/L. Outcomes and mortality were compared between groups. RESULTS: The mean age for the study population was 56.21 ± 15.13 years, and 57 patients (58.8%) were male. The mean time on CentriMag support was 22.7 days. Patients with serum sodium levels ≤135 mEq/L were noted to have significantly worsened indicators of preoperative cardiac function. However, patients with serum sodium levels >135 mEq/L had significantly shorter postoperative survival ( P = .006). When entered into a multivariate Cox proportional hazards model, sodium was an independent predictor for increased risk of mortality (hazard ratio: 1.224; 95% confidence interval: 1.009-1.485; P = .040). CONCLUSION: Our results indicate that elevated preoperative sodium in patients undergoing implantation of a temporary mechanical circulatory support system is predictive of worsened postoperative survival.

The impact of extreme obesity on outcomes after left ventricular assist device implantation.

BACKGROUND: The association between extreme body mass index (BMI) and outcomes in left ventricular assist device (LVAD) patients has not been well established. With the commercial use of LVADs a larger number of patients with a BMI >40 have undergone device implantation. The purpose of this study was to evaluate the short and long-term outcomes of LVAD patients with extreme obesity. METHODS: A retrospective review of all patients (n=383) at our center who received a LVAD as primary implant between 2005-2015 was performed. Demographics, preoperative laboratory values, and postoperative outcomes were analyzed. Patients were divided into three groups based on BMI (kg/m2) classification (group 1: ≤25; group 2: 25 to 35; group 3: ≥35) and compared using one-way analysis of variance (ANOVA), Kruskal-Wallis and Chi-squared analysis as appropriate. RESULTS: Comparison of postoperative outcomes demonstrated an increased risk of respiratory failure and right ventricular (RV) failure in patients with a BMI ≥35 (range, 35-59). Length of stay, sternal infection, driveline/pocket infection, systemic infection, GI-bleeding, and neurological events within the first year of device therapy were not related to BMI. Survival at 30-day, 1- and 2-year was not significantly different among the three groups. The group with the smallest BMI demonstrated an increased risk for re-operative bleeding. CONCLUSIONS: Despite an increased risk of early morbidity in patients with extreme obesity, long term survival was not significantly different between the BMI groups. Careful consideration is recommended when evaluating patients with an excessive BMI for LVAD therapy although it should not be a contraindication for device placement.

A novel obstetric medical device designed for autotransfusion of blood in life threatening postpartum haemorrhage.

Postpartum haemorrhage (PPH) is an obstetric emergency caused by excessive blood loss after delivery, which is the leading cause of maternal mortality worldwide. PPH can lead to volume depletion, hypovolemic shock, anaemia and ultimately death. The prevalence of PPH is disproportionately higher in low resource settings where there is limited access to skilled medical care and safe blood supplies. Current management strategies target both prevention and treatment of PPH however no alternatives currently exist to address the lack of safe blood supplies which are considered essential in emergency obstetrical care. Autotransfusion is used to salvage blood loss in a variety of clinical settings but has never been used in the context of vaginal delivery. We describe the development and testing of a novel device for the collection, filtration and autotransfusion of blood lost due to PPH. The prototype device is inexpensive and easily operated so that it may be practically deployed in low resource settings. The device is comprised of a blood collection drape, a pump apparatus, three leukocyte reduction filters and a reservoir for filtered blood. Preliminary testing demonstrates efficacy of microbial load reduction of up to 97.3%. To reduce cost and improve safety, the device is modular in design such that the drape, tubing, filters and transfusion bag may be stored sterile, used once and discarded; while the pump apparatus may be used indefinitely without the need for sterilisation. Preliminary results indicate the device confers a low cost and potentially effective means of collecting, pumping, filtering and returning blood to a patient following PPH in settings that lack safe blood supplies. This device shows promise as a method of stabilising patients suffering of PPH in low resource settings until definitive treatment is rendered with the ultimate goal of reducing maternal mortality globally.

Is Diabetes Mellitus a Risk Factor for Poor Outcomes after Left Ventricular Assist Device Placement?

Diabetes mellitus is associated with adverse outcomes in patients with cardiovascular diseases, including heart failure. Left ventricular assist devices (LVADs) are increasingly used as life-saving therapy for advanced heart failure. The effects of pre-LVAD diabetes on long-term outcomes after LVAD implantation are not well understood. In this study, we retrospectively evaluated the effect of existing diabetes on post-LVAD outcomes. Data on 288 LVAD recipients from 2006 through 2013 were reviewed. Patients were stratified in accordance with their histories of diabetes. Baseline demographic, laboratory, hemodynamic, and echocardiographic information before LVAD placement were reviewed, together with the post-LVAD incidence of major adverse outcomes. Kaplan-Meier analysis and Cox regression analysis were performed. Our cohort comprised 122 patients with diabetes and 166 patients without. The mean glycosylated hemoglobin A1c level in the diabetes group was 7.4% ± 1.6%. Diabetic patients at baseline had a more adverse medical profile than did nondiabetic patients. There were no differences in major outcomes between the 2 groups other than a higher incidence of hemolysis in the diabetes group: 12 (10%) vs 5 (3%); P=0.02. There was no difference in survival outcomes between the groups. Diabetic patients did not have worse survival or more adverse outcomes than did nondiabetic patients in this study, perhaps because of improved diabetes control, or improvement in biochemical derangements after normalization of cardiac output with LVAD therapy. A diagnosis of diabetes was an independent predictor of hemolysis. Further studies to evaluate the link between hemolysis and diabetes are indicated.