Protein-based oral rehydration solutions for patients with an ileostomy: A randomised, double-blinded crossover study.

BACKGROUND & AIM: Patients with an ileostomy are at increased risk of dehydration and sodium depletion. Treatments recommended may include oral rehydration solutions (ORS). We aimed to investigate if protein type or protein hydrolysation affects absorption from iso-osmolar ORS in patients with an ileostomy. METHODS: This was a randomised, double-blinded, active comparator-controlled 3 × 3 crossover intervention study. We developed three protein-based ORS with whey protein isolate, caseinate or whey protein hydrolysate. The solutions contained 40-48 g protein/L, 34-45 mmol sodium/L and had an osmolality of 248-270 mOsm/kg. The patients ingested 500 mL/d. The study consisted of three 4-week periods with a >2-week washout between each intervention. The primary outcome was wet-weight ileostomy output. Ileostomy output and urine were collected for a 24-h period before and after each intervention. Additionally, blood sampling, dietary records, muscle-strength tests, bioimpedance analyses, questionnaires and psychometric tests were conducted. RESULTS: We included 14 patients, of whom 13 completed at least one intervention. Ten patients completed all three interventions. Wet-weight ileostomy output did not change following either of the three interventions and did not differ between interventions (p = 0.38). A cluster of statistically significant improvements related to absorption was observed following the intake of whey protein isolate ORS, including decreased faecal losses of energy (-365 kJ/d, 95% confidence interval (CI), -643 to -87, p = 0.012), potassium (-7.8 mmol/L, 95%CI, -12.0 to -3.6, p = 0.001), magnesium (-4.0 mmol/L, 95%CI, -7.4 to -0.7, p = 0.020), improved plasma aldosterone (-4674 pmol/L 95%CI, -8536 to -812, p = 0.019), estimated glomerular filtration rate (eGFR) (2.8 mL/min/1.73 m2, 95%CI, 0.3 to 5.4, p = 0.03) and CO2 (1.7 mmol/L 95%CI, 0.1 to 3.3, p = 0.04). CONCLUSION: Ingestion of 500 mL/d of iso-osmolar solutions containing either whey protein isolate, caseinate or whey protein hydrolysate for four weeks resulted in unchanged and comparable ileostomy outputs in patients with an ileostomy. Following whey protein isolate ORS, we observed discrete improvements in a series of absorption proxies in both faeces and blood, indicating increased absorption. The protein-based ORS were safe and well-tolerated. Treatments should be tailored to each patient, and future studies are warranted to explore treatment-effect heterogeneity and whether different compositions or doses of ORS can improve absorption and nutritional status in patients with an ileostomy. GOV STUDY IDENTIFIER: NCT04141826.

Osmolality in oral supplements drives ileostomy output: Defining the Goldilocks zone.

BACKGROUND: Patients with an ileostomy often have impaired quality of life, sodium depletion, secondary hyperaldosteronism, and other organ-specific pathologies. The osmolality of oral supplements influences ileostomy output and increases sodium loss. We hypothesized the existence of an osmolality range in which fluid absorption and secondary natriuresis are optimal. METHODS: This was a single-center, quasi-randomized crossover intervention study, including patients with an ileostomy and no home parenteral support. After an 8-h fasting period, each patient ingested 500 mL of 3-18 different oral supplements and a standardized meal during the various intervention periods, followed by a 6-h collection of ileostomy and urine outputs. The primary outcome was 6-h ileostomy output. RESULTS: A total of 14 ileostomy patients with a median age of 65 years (interquartile range 38-70 years) were included. The association between osmolalities (range 5-1352 mOsm/kg) and ileostomy output forecasted an S-curve. A linear association between osmolality of oral supplements (range 290-600 mOsm/kg) and ileostomy output was identified and assessed with a mixed-effects model. Ileostomy output increased by 57 g/6 h (95% confidence interval (CI) 21-94) when the oral supplement osmolality increased by 100 mOsm/kg (p = 0.005). CONCLUSION: Osmolality in oral supplements correlated with ileostomy output. Our results indicate that patients with an ileostomy may benefit from increased ingestion of oral supplements with osmolalities between 100 and 290 mOsm/kg. We define this range as the Goldilocks zone, equivalent to optimal fluid and electrolyte absorption.

Bioelectrical impedance analysis as a clinical marker of health status in adult patients with benign gastrointestinal disease: A systematic review.

BACKGROUND: Body composition reflects nutritional status, disease status and progression, and treatment responses. Mounting evidence supports the use of bioelectrical impedance analysis (BIA) as a non-invasive tool to assess body composition. Patients with benign gastrointestinal (GI) disease experience disease-related alterations in their body composition, and bioimpedance outcomes in patients with benign GI diseases have not previously been summarized. We aimed to evaluate BIA as a clinical body composition marker for benign GI diseases and describe its association with physical health status. METHODS: We systematically searched PubMed, Scopus, Web of Science, Embase, and CINAHL from inception to October 2023 (PROSPERO registration: CRD42021265866). Of 971 screened studies, 26 studies were included in the final analysis, comprising a total of 2398 adult patients with benign GI disease. The main outcome was raw impedance data. RESULTS: The most frequently reported BIA outcome was phase angle (PhA) (reported in 18 of 26 studies), followed by fat-free-mass (FFM) (reported in 13 of 26 studies). The consensus view of the included studies illustrates that BIA can be a useful tool for evaluating body composition in patients with benign GI diseases, and low PhA and FFM were associated with increased nutritional risk, abnormal physical characteristics, and increased mortality risk. CONCLUSION: To fully utilize BIA as a clinical marker of health in patients with benign GI disease, standardized protocols specific to this population are needed and prospective studies testing cut-offs and ranges, accuracy, and other raw BIA parameters for classifying disease status.

Sodium depletion and secondary hyperaldosteronism in outpatients with an ileostomy: a cross-sectional study.

OBJECTIVE: Patients with an ileostomy may experience postoperative electrolyte derangement and dehydration but are presumed to stabilise thereafter. We aimed to investigate the prevalence of sodium depletion in stable outpatients with an ileostomy and applied established methods to estimate their fluid status. METHODS: We invited 178 patients with an ileostomy through a region-wide Quality-of-Life-survey to undergo outpatient evaluation of their sodium and fluid status. The patients delivered urine and blood samples, had bioelectrical impedance analysis performed and answered a questionnaire regarding dietary habits. RESULTS: Out of 178 invitees, 49 patients with an ileostomy were included; 22 patients (45%, 95% CI, 31-59%) had unmeasurably low urinary sodium excretion (<20 mmol/L), indicative of chronic sodium depletion, and 26% (95% CI, 16-41%) had plasma aldosterone levels above the reference value. Patients with unmeasurably low urinary sodium excretion had low estimated glomerular filtration rates (median 76, IQR 63-89, mL/min/1.73m2) and low venous blood plasma CO2 (median 24, IQR 21-26, mmol/L), indicative of chronic renal impairment and metabolic acidosis. Bioelectrical impedance analysis, plasma osmolality, creatinine and sodium values were not informative in determining sodium status in this population. CONCLUSION: A high proportion of patients with an ileostomy may be chronically sodium depleted, indicated by absent urinary sodium excretion, secondary hyperaldosteronism and chronic renal impairment, despite normal standard biochemical tests. Sodium depletion may adversely affect longstanding renal function. Future studies should investigate methods to estimate and monitor fluid status and aim to develop treatments to improve sodium depletion and dehydration in patients with an ileostomy.IMPACT AND PRACTICE RELEVANCE STATEMENTSodium depletion in otherwise healthy persons with an ileostomy was identified in a few publications from the 1980s. The magnitude of the problem has not been demonstrated before. The present study quantifies the degree of sodium depletion and secondary hyperaldosteronism in this group, and the results may help guide clinicians to optimise treatment. Sodium depletion is easily assessed with a urine sample, and sequelae may possibly be avoided if sodium depletion is detected early and treated. This could ultimately help increase the quality of life in patients with an ileostomy.

Nutritional risk screening in a Danish university hospital is insufficient and may underestimate nutritional risk: A cross-sectional study.

BACKGROUND: Disease-related-malnutrition predicts poor clinical outcomes in elderly patients, and screening is pivotal for identifying patients at nutritional risk. The present study aimed to investigate nutrition screening rates in electronic patient records and validate the scores given. A secondary aim was to investigate whether the proportion of patients at risk differed between patients where screening was documented and those where no screening was documented. METHODS: This cross-sectional observational study was conducted in a Danish university hospital during November 2020. Patients aged 65 years or more admitted to a medical department were included. The Nutrition Risk Screening 2002 (NRS-2002) tool was used to identify patients at nutritional risk, both in routine clinical care, where data were collected retrospectively, and during a validation process in a random patient sample, where data were collected prospectively. RESULTS: In total, 817 patients were admitted for more than 24 h. Of these, an NRS-2002 score was documented in 294 (36%), among whom 177 (60%) were at nutritional risk. In 146 patients where no score was documented, 88 (60%) were at risk. Validation was possible in 91 patients where a record-based score and a validated score were documented. The specificity of the record-based score was 100%, whereas the sensitivity was 75%, indicating that routine screening underestimated nutritional risk (p < 0.001, proportion difference 19%; 95% confidence interval = 10%-28%). CONCLUSIONS: Electronic documentation does not solve issues about compliance with nutritional risk screening. In patients where screening was not documented, the occurrence of nutritional risk was similar, indicating that omission of screening is not related to the score.

Long-term maintenance treatment with 300 mg thiamine for fatigue in patients with inflammatory bowel disease: results from an open-label extension of the TARIF study.

OBJECTIVE AND AIMS: Fatigue is common in inflammatory bowel disease (IBD). In a RCT we demonstrated reductions in fatigue after 4 weeks' treatment with high-dose oral thiamine. We aimed to investigate whether 300 mg thiamine daily for 12 weeks could maintain the achieved levels of fatigue in patients with IBD after a 4-week intervention with high-dose thiamine; and evaluate the effect of a 6-month period where patients were free to take oral thiamine. METHODS: A randomised, open-label, controlled trial, performed as a long-term extension (LTE) study of an initial randomised, high-dose thiamine trial. Patients were allocated 1:1 to 300 mg oral thiamine or no thiamine for 12 weeks. Subsequently, the patients were allowed to self-treat with over-the-counter (OTC) oral thiamine 6-month. RESULTS: Regardless of allocation in the LTE study fatigue severity increased in the study period. No significant effect of 300 mg oral thiamine were found, when stratifying for initial allocation in the high-dose study or fatigue level at entry in the LTE study. Patients who took OTC thiamine had lower level of fatigue 6 month later (7.8; 95% CI: 5.5-10.1) when compared to the remains (11.0; 95% CI: 9.2-12.8) (p = .02). After the 6-months follow-up without restrictions, 66% of patients had reached normal fatigue levels. CONCLUSIONS: We found no beneficial effect on fatigue from thiamine taken in doses of 300 mg per day for 12 weeks following high-dose treatment. After a 6-months follow-up without restrictions 66% had reached a normal level of fatigue. CLINICAL TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov under study identifier NCT03634735.

Patient-Reported Outcomes and Health-Related Quality of Life in People Living With Ileostomies: A Population-Based, Cross-Sectional Study.

BACKGROUND: The impact of a stoma on long-term health-related quality of life in people living with ileostomies is not clear. OBJECTIVE: This study aimed to describe important patient-reported outcomes and health-related quality of life in people with ileostomies. DESIGN: This is a population-based, cross-sectional study. Patients were invited to answer questionnaires estimating stoma-specific and generic health-related quality of life (EQ-5D-5L and the Major Depression Inventory). Danish norms were retrieved from reference literature. SETTINGS: This study was conducted at the major stoma clinic at Aarhus University Hospital, Denmark. PATIENTS: We invited all patients with ileostomies who were in contact with the clinic between 2012 and 2017. MAIN OUTCOME MEASURES: The primary outcomes measured were patient-reported outcomes specific to people with ileostomies. RESULTS: Of 621 identified patients (50% women), 412 (67%) responded to the survey. Among the responders, 178 (43%) reported that they still had an ileostomy at the time of the survey and were included in the analysis. Fatigue was frequent; 68% (95% CI 60%-75%) reported being tired and 26% (95% CI 20%-33%) answered that they were "always tired," whereas 43% (95% CI 36%-51%) lacked energy, 62% (95% CI 54%-69%) reported poor sleep, and 59% (95% CI 52%-66%) needed to rest during the day. Fifty-six percent (95% CI 48%-63%) needed to know the immediate location of the nearest toilet, and 58% (95% CI 51%-66%) felt sexually unattractive because of their ileostomy. Health-related quality of life measured with generic questions indicated 0.124 points lower health-related quality of life than the Danish norm ( p < 0.001), and 18% (95% CI 13%-25%) scored above the threshold for depression, which is 2.6 times higher than the background population (7%, 95% CI 6%-9%; p < 0.001). LIMITATIONS: This study was limited by potential selection bias, and all participants did not answer all items. CONCLUSIONS: Fatigue and low health-related quality of life is common in people living with ileostomies. Addressing fatigue and stoma-specific challenges in patients with an ileostomy is warranted. See Video Abstract at http://links.lww.com/DCR/B803 . DESENLACES INFORMADOS POR PACIENTES Y CALIDAD DE VIDA RELACIONADA CON LA SALUD EN PERSONAS QUE VIVEN CON ILEOSTOMAS UN ESTUDIO TRANSVERSAL POBLACIONAL: ANTECEDENTES:El impacto de un estoma en la calidad de vida relacionada con la salud a largo plazo en personas que viven con ileostomías no está claro.OBJETIVO:Describir desenlaces importantes informados por pacientes y la calidad de vida relacionada con la salud en personas con ileostomías.DISEÑO:Estudio transversal poblacional. Se invitó a los pacientes a responder cuestionarios que estiman la calidad de vida relacionada con la salud general y específica del estoma (EQ-5D-5L y el Inventario de depresión mayor). Las normas danesas se recopilaron de la literatura de referencia.AJUSTES:El estudio se llevó a cabo en la clínica principal de estomas del Hospital Universitario de Aarhus, Dinamarca.PACIENTES:Invitamos a todos los pacientes con ileostomías que estuvieron en contacto con la clínica entre 2012 y 2017.PRINCIPALES MEDIDAS DE RESULTADO:Resultados informados por el paciente específicos para personas con ileostomías.RESULTADOS:De 621 pacientes identificados (50% mujeres), 412 (66%) respondieron la encuesta. Entre los que respondieron, 178 (43%) informaron que todavía tenían una ileostomía en el momento de la encuesta y fueron incluidos en el análisis. La fatiga era frecuente; el 68% (intervalo de confianza del 95%: 60-75%) informó estar cansado y el 26% (20-33%) respondió "siempre cansado", mientras que el 43% (36-51%) carecía de energía, el 62% (54-69%)) refirieron dormir mal y el 59% (52-6%) necesitaba descansar durante el día. El cincuenta y seis por ciento (48-63%) necesitaba saber la ubicación inmediata del baño más cercano y el 58% (51-66%) se sentía sexualmente poco atractivo debido a su ileostomía. La calidad de vida relacionada con la salud medida con preguntas genéricas indicó una calidad de vida relacionada con la salud 0,124 puntos más baja que la norma danesa ( p < 0,001), y el 18% (13-25%) puntuó con depresión, que es 2.6 veces más alta que la población de base (7%, 6-9%, p < 0,001).LIMITACIONES:Posible sesgo de selección, y no todos los participantes respondieron a todos los ítems.CONCLUSIONES:La fatiga y la baja calidad de vida relacionada con la salud es común en las personas que viven con ileostomías. Se justifica abordar la fatiga y los desafíos específicos del estoma en pacientes con una ileostomía. Consulte Video Resumen en http://links.lww.com/DCR/B803 . (Traducción-Juan Carlos Reyes ).

Systematic review with meta-analysis: effects of implementing a nutrition support team for in-hospital parenteral nutrition.

BACKGROUND: Nutrition support teams (NST) may improve parenteral nutrition (PN) outcomes. No previous systematic review has provided conclusive data on catheter-related infection (CRI) occurrence after NST introduction, nor have previous studies performed meta-analysis or graded the evidence. AIMS: To systematically evaluate the effects of implementing an NST for hospitalised adults on PN and compare these with standard care. METHODS: This was a systematic review and meta-analysis, pre-registered in PROSPERO (CRD42020218094). On November 24, 2020, PubMed, Web of science, Scopus, Embase, Cochrane Library, and Clinical Key were searched. Clinical trials and observational studies with a standard care comparator were included. Primary outcome was relative reduction in CRI rate. A random-effects meta-analysis was used to estimate effects, and evidence was rated using Cochrane and GRADE methodologies. RESULTS: Twenty-seven studies with 8166 patients were included. Across 10 studies, NST introduction reduced the CRI rate (IRR = 0.32, 95% CI: 0.19-0.53) with -8 (95% CI: -12 to -5) episodes per 1000 catheter days compared with standard care. Hypophosphataemia occurred less frequently (IRD = -12%, 95% CI: -24% to -1%) and 30-day mortality decreased (IRD = -6%, 95% CI: -11% to -1%). Inappropriate PN use decreased, both judged by indication (IRD = -18%, 95% CI: -28% to -9%) and duration (IRD = -21%, 95% CI: -33% to -9%). Evidence was rated very low to moderate. CONCLUSIONS: This study documents the clinical impact of introducing an NST, with moderate-grade evidence for the reduction of CRI occurrence compared with standard care. Further, NST introduction significantly reduced metabolic complications, mortality, and inappropriate PN use.

Randomised clinical trial: high-dose oral thiamine versus placebo for chronic fatigue in patients with quiescent inflammatory bowel disease.

BACKGROUND: Fatigue is a burdensome symptom for patients with inflammatory bowel disease (IBD). Few pharmacological interventions have documented effect on fatigue in patients with IBD. A pilot study indicated a 20-day effect  with high-dose thiamine. AIMS: To investigate the effect and safety of high-dose oral thiamine (600-1800 mg/d) based on gender and weight on chronic fatigue in patients with quiescent IBD. METHODS: This was a randomised, double-blinded, placebo-controlled crossover trial. Patients had quiescent IBD, severe chronic fatigue and no other explanation for fatigue. Patients were allocated 1:1 to either 1) high-dose oral thiamine for 4 weeks, 4 weeks of washout, 4 weeks of oral placebo or 2) oral placebo for 4 weeks, 4 weeks of washout, 4 weeks of high-dose oral thiamine. Fatigue was measured using the Inflammatory Bowel Disease-Fatigue Questionnaire. The primary outcome was improvement (≥3 points) of fatigue after 4 weeks on thiamine. RESULTS: Forty patients were enrolled between November 2018 and October 2019. Crossover analysis showed a mean reduction of 4.5 points (95% CI 2.6-6.2) in fatigue after thiamine compared with a mean increase of 0.75 point (95% CI -1.3-2.8; P = 0.0003) after placebo. Furthermore, 55% of group 1 and 75% of group 2 showed an improvement ≥ 3 points while on thiamine compared with 25% of group 1 and 35% of group 2 while on placebo. Only mild side effects were detected. CONCLUSION: We showed a significant beneficial effect of high-dose oral thiamine on chronic fatigue in IBD. The treatment was well tolerated. TRIAL REGISTRATION: NCT03634735.

Effect of High Versus Low Carbohydrate Intake in the Morning on Glycemic Variability and Glycemic Control Measured by Continuous Blood Glucose Monitoring in Women with Gestational Diabetes Mellitus-A Randomized Crossover Study.

Carbohydrate is the macronutrient that has the greatest impact on blood glucose response. Limited data are available on how carbohydrate distribution throughout the day affects blood glucose in women with gestational diabetes mellitus (GDM). We aimed to assess how a high-carbohydrate morning-intake (HCM) versus a low-carbohydrate-morning-intake (LCM), affect glycemic variability and glucose control. In this randomized crossover study continuous glucose monitoring (CGM) was performed in 12 women with diet treated GDM (75 g, 2-h OGTT ≥ 8.5 mmol/L), who went through 2 × 3 days of HCM and LCM. A within-subject-analysis showed a significantly higher mean amplitude of glucose excursions (MAGE) (0.7 mmol/L, p = 0.004) and coefficient of variation (CV) (5.1%, p = 0.01) when comparing HCM with LCM, whereas a significantly lower mean glucose (MG) (-0.3 mmol/L, p = 0.002) and fasting blood glucose (FBG) were found (-0.4 mmol/L, p = 0.01) on the HCM diet compared to the LCM diet. In addition, insulin resistance, expressed as Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), decreased significantly during HCM. Results indicate that a carbohydrate distribution of 50% in the morning favors lower blood glucose and improvement in insulin sensitivity in women with GDM, but in contrary gives a higher glycemic variability.

A Single Urine Sodium Measurement May Validly Estimate 24-hour Urine Sodium Excretion in Patients With an Ileostomy.

BACKGROUND: Sodium deficiency in patients with an ileostomy is associated with chronic dehydration and may be difficult to detect. We aimed to investigate if the sodium concentration in a single spot urine sample may be used as a proxy for 24-hour urine sodium excretion. METHODS: In a prospective observational study with 8 patients with an ileostomy and 8 volunteers with intact intestines, we investigated the correlations and agreements between spot urine sodium concentrations and 24-hour urine sodium excretions. Spot urine samples were drawn from every micturition during 24 hours, and relevant blood samples were drawn. All participants documented their food and fluid intakes. RESULTS: There was a high and statistically significant correlation between 24-hour natriuresis and urine sodium concentrations in both morning spot samples (n = 8, Spearman's rho [ρ] = 0.78, P = 0.03) and midday spot samples (n = 8, ρ = 0.82, P = 0.02) in the patients with an ileostomy. The agreement between methods was fair (bias = -1.5, limits of agreement = -32.3 to 29.4). There were no statistically significant associations for evening samples or for samples from volunteers with intact intestines independently of time of day. CONCLUSION: A single spot urine sodium sample obtained in the morning or midday may estimate 24-hour urine sodium excretion in patients with an ileostomy and thus help to identify sodium depletion.

An iso-osmolar oral supplement increases natriuresis and does not increase stomal output in patients with an ileostomy: A randomised, double-blinded, active comparator, crossover intervention study.

BACKGROUND: Patients with an ileostomy often experience fluid and electrolyte depletion because of gastrointestinal loss. This study aimed to compare how an iso-osmolar and a hyperosmolar oral supplement affect ileostomy output, urine production, and natriuresis as proxy measurements of water-electrolyte balance. METHODS: In a randomised, double-blinded, active comparator, crossover intervention study, we included eight adult ileostomy patients who were independent of parenteral support. We investigated how an iso-osmolar (279 mOsm/kg) and a hyperosmolar (681 mOsm/kg) oral supplement affected ileostomy output mass, urine volume, and natriuresis. In addition to their habitual diet, each participant ingested 800 mL/day of either the iso-osmolar or hyperosmolar supplement in each of two study periods. Each period started with 24-hour baseline measurements, and the supplements were ingested during the following 48 h. All measurements were repeated in the last 24 h. RESULTS: No statistically significant changes in ileostomy output were detected following the intake of either oral supplement (median (range) 67 (-728 to 290) g/day, p = 0.25) despite increased fluid intake. Compared with the hyperosmolar supplement, the iso-osmolar supplement induced a statistically significant increase in urine volume (470 (0-780) mL/day, p = 0.02) and natriuresis (36 (0-66) mmol/day, p = 0.02). CONCLUSION: Intake of the two oral supplements did not affect ileostomy output during this short intervention. Natriuresis increased following intake of the iso-osmolar supplement compared to that after ingesting the hyperosmolar supplement, indicating that patients with an ileostomy may benefit from increasing their ingestion of iso-osmolar fluids. ClinicalTrials.gov identifier:NCT03348709.

Impella CP or VA-ECMO in profound cardiogenic shock: left ventricular unloading and organ perfusion in a large animal model.

AIMS: The aim of this study was to evaluate the Impella CP over veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and their impact on left ventricular unloading and end-organ perfusion. METHODS AND RESULTS: Cardiogenic shock (CS) was induced by injecting microspheres into the left coronary artery in fourteen adult female swine. Impella CP or VA-ECMO was initiated in the presence of CS and evaluated after 60 minutes. Left ventricular pressure-volume area (PVA, total mechanical work) was obtained from a conductance catheter. Results are presented as mean (95% confidence interval) and the rank-sum test was used to assess differences between devices. Compared to the CS state, PVA was unaffected by Impella CP and increased on VA-ECMO (from 2,548 [2,193; 2,904] mmHg x mL during CS to 5,775 [4,451; 7,099], between device p-value=0.02). Arterial lactate increased during CS and decreased on support with no difference between devices. Renal venous oxygen saturation decreased during CS and increased on support with no difference between devices. Cerebral venous oxygen saturation increased to 33% [25, 40] on Impella CP and to 69% [49, 89] on VA-ECMO, p=0.04. CONCLUSIONS: In this porcine model of profound CS, Impella CP unloaded the left ventricle compared to VA-ECMO. Both devices improved end-organ perfusion, with a tendency towards higher venous oxygen saturations on VA-ECMO.

Single-centre experience with the Impella CP, 5.0 and RP in 109 consecutive patients with profound cardiogenic shock.

RATIONALE: Short-term mechanical circulatory support is increasingly used in the management of cardiogenic shock, but data from controlled studies are sparse. Thus, real-life data on complication rates and predictors of adverse outcome are important. OBJECTIVE: The objective of this study was to analyse the experience with Impella devices in the management of profound cardiogenic shock. METHODS AND RESULTS: A retrospective study of 109 consecutive patients with severe shock after myocardial infarction, acute heart failure, or cardiac surgery. Possible device-related complications were registered and predictors of death while on Impella support and within 180 days were identified. In 79 patients (72%) cardiogenic shock was caused by myocardial infarction, acute heart failure in 16 (15%) and post-cardiotomy shock in 14 patients (13%). Thirty-five patients (32%) were comatose after cardiac arrest and in seven, the Impella was placed during chest compression. Mean age was 62±12 years, mean arterial pressure was 57±13 mmHg, pH 7.19±0.17 and lactate 7.5±5.7 mmol/l (range 1.8-30.0 mmol/l) at placement. During Impella therapy, 26 patients (28%) died among patients with myocardial infarction or acute heart failure. Of data available prior to placement lactate (hazard ratio 1.14, 95% confidence interval 1.04-1.25, P=0.004) was the only predictor of death on support. During support, five patients (5%) developed leg ischaemia requiring intervention. Bleeding from the Impella insertion site was seen in 14 patients (13%). CONCLUSION: Impella treatment is feasible in profound cardiogenic shock at an acceptable rate of complications. Despite an aggressive approach to restore cardiac output, mortality was high. Besides the severity of lactic acidosis there were no strong predictors of early death.