Asanguineous Cardiopulmonary Bypass in Infants: Impact on Postoperative Mortality and Morbidity.

BACKGROUND: We routinely start cardiopulmonary bypass (CPB) for pediatric congenital heart surgery without homologous blood, due to circuit miniaturization, and blood-saving measures. Blood transfusion is applied if hemoglobin concentration falls under 8 g/dL, or it is postponed to after coming off bypass or after operation. How this strategy impacts on postoperative mortality and morbidity, in infants weighing ≤ 7 kg? METHODS: Six-hundred fifteen open-heart procedures performed from January 2014 to June 2018 were selected. One-hundred sixty-three patients (26.5%) were transfused on CPB (group 1), while 452 (73.5%) patients were not transfused on CPB (group 2). Operative risk and complexity were similar in both groups. Postoperative mortality and morbidity were compared. Multiple logistic regression was used to detect factors independently associated with outcome. RESULTS: Observed mortality in nontransfused group (0.7% = 3/452) was significantly lower than expected (4.2% = 19/452): p = 0.0007, and much lower than in transfused group (6.7% = 11/163): p < 0.0001. CPB transfusion (p = 0.001) was independently associated with mortality, either acting as the sole factor or in combination with the Society of Thoracic Surgeons morbidity score (p = 0.013). Patients not transfused during CPB required less frequently vasoactive inotropic drugs (p = 0.011) and duration of their mechanical ventilation was shorter (93 ± 134 hours) than for transfused patients (142 ± 170 hours): p = 0.0003. CPB transfusion was an independent determinant factor for morbidity (p = 0.05), together with body weight (p < 0.0001), vasoactive inotropic score (p < 0.0001), CPB duration (p = 0.001), and postoperative transfusion (p = 0.009). CONCLUSION: The strategy of transfusion-free CPB course, feasible in most patients ≤ 7kg, was associated with improved outcome. Asanguineous priming of CPB circuit should become standard, even in neonates and infants.

Cardiopulmonary Bypass Strategy to Facilitate Transfusion-Free Congenital Heart Surgery in Neonates and Infants.

Priming the cardiopulmonary bypass (CPB) circuit without the addition of homologous blood constitutes the basis of blood-saving strategies in open-heart surgery. For low-weight patients, in particular neonates and infants, this implies avoidance of excessive hemodilution during extracorporeal circulation. The circuit has to be miniaturized and tubing must be cut as short as possible to reduce the priming volume to prevent unacceptable hemodilution with initiating CPB. During perfusion, measures should be taken to prevent blood loss from the primary circuit to avoid replacement by additional volume. Favorable factors such as mild hypothermia/normothermia and high heparin concentrations during extracorporeal circulation promote earlier hemostasis after coming off bypass.Lower mortality score, first chest entry, higher hemoglobin concentration before going on bypass, and shorter CPB duration support transfusion-free CPB procedure. Reduced postoperative morbidity and mortality were observed when CPB was performed without blood transfusion. In our experience, this can be achieved in at least 70% of CPBs, even in low-weight patients.Bloodless CPB circuit priming should become a widespread reality, even in neonates and young infants, in any open-heart procedure.

Long-term survival and quality of life in Jehovah's witnesses after cardiac surgery: a case control study.

BACKGROUND: We previously analyzed morbidity and mortality in Jehovah's Witnesses patients after cardiac surgery compared to control population patients. Patients who were Jehovah's Witnesses were operated in accordance with their philosophical convictions and in respect of their refusal of transfusions. We propose to assess long-term survival and quality of life in the patients of this preliminary study. METHODS: We contacted 31 adult Jehovah's Witnesses patients who underwent heart surgery at the Brugmann hospital between 1991 and 2012 and compared them to a control population of 62 patients that had no transfusion restriction, and matched them for sex, age at the time of intervention and the type of surgery performed. We compared long-term quality of life in both populations through the MacNew software, a validated instrument to assess quality of life of patients with cardiovascular disease. The long-term survival of patients was analyzed by Kaplan Meier curves. RESULTS: Long-term quality of life and survival do not appear different between the two groups. Patient evaluation by MacNew software shows comparable physical (p = 0.54), emotional (p = 0.12), social (p = 0.21) and global (p = 0.25) scores between the two populations. The analysis of the actuarial survival curves shows no differences in terms of long-term survival of these patients (p = 0.37). CONCLUSIONS: Cardiac surgery in Jehovah's Witnesses can be performed with identical long-term quality of life and survival compared to surgery without blood transfusion restriction, if one follows rigorous blood conserving strategies. TRIAL REGISTRATION: NCT03348072 . Retrospectively registered 16 November 2017.

Effects of restrictive red blood cell transfusion on the prognoses of adult patients undergoing cardiac surgery: a meta-analysis of randomized controlled trials.

PURPOSE: Restrictive red blood cell transfusion strategies remain controversial in patients undergoing cardiac surgery. We performed a meta-analysis to assess the prognostic benefits of restrictive red blood cell transfusion strategies in patients undergoing cardiac surgery. METHODS: We identified randomized clinical trials through the 9th of December 2017 that investigated a restrictive red blood cell transfusion strategy versus a liberal transfusion strategy in patients undergoing cardiac surgery. Individual patient data from each study were collected. Meta-analyses were performed for the primary and secondary outcomes. The risk of bias was assessed using the Cochrane Risk of Bias Tool. A trial sequential analysis (TSA)-adjusted random-effects model was used to pool the results from the included studies for the primary outcomes. RESULTS: Seven trials involving a total of 8886 patients were included. The TSA evaluations suggested that this meta-analysis could draw firm negative results, and the data were sufficient. There was no evidence that the risk of 30-day mortality differed between the patients assigned to a restrictive blood cell transfusion strategy and a liberal transfusion strategy (odds ratio (OR) 0.98; 95% confidence interval (CI) 0.77 to 1.24; p = 0.87). Furthermore, the study suggested that the restrictive transfusion strategy was not associated with significant increases in pulmonary morbidity (OR 1.09; 95% CI 0.88 to 1.34; p = 0.44), postoperative infection (OR 1.11; 95% CI 0.95 to 1.3; p = 0.58), acute kidney injury (OR 1.03; 95% CI 0.92 to 1.14; p = 0.71), acute myocardial infarction (OR 1.01; 95% CI 0.80 to 1.27; p = 0.78), or cerebrovascular accidents (OR 0.97; 95% CI 0.72 to 1.30; p = 0.66). CONCLUSIONS: Our meta-analysis demonstrates that the restrictive red blood cell transfusion strategy was not inferior to the liberal strategy with respect to 30-day mortality, pulmonary morbidity, postoperative infection, cerebrovascular accidents, acute kidney injury, or acute myocardial infarction, and fewer red blood cells were transfused.

Transfusion-free management of gastrointestinal bleeding: the experience of a bloodless institute.

GOALS: The Institute for Patient Blood Management and Bloodless Medicine at the Englewood Hospital has considerable experience in managing patients with gastrointestinal bleeding who do not accept blood-derived products. We present our data and experience over the last 8 years in managing such patients. BACKGROUND: There is paucity of data on management and outcomes of gastrointestinal bleeding in patients who do not accept blood-derived products. STUDY: We performed a retrospective study of patients from 2003 to 2011 presenting with gastrointestinal bleeding who do not accept blood-derived products. Inclusion criteria were either overt bleeding with a presenting hemoglobin (Hb) of <12 g/dL or a decrease in Hb of >1.5 g/dL. RESULTS: Ninety-six patients who met the inclusion criteria were included. Forty-one upper and 48 lower gastrointestinal bleeding sources were identified. Mean Hb was 8.8 g/dL and mean nadir was 6.9 g/dL. Among 37 patients (80.5%) with Hb ≤6.0 g/dL, 30 (81%) survived. Four of 7 patients (57%) with a Hb <3 g/dL survived. The overall mortality rate was 10.4%. In unadjusted logistic regression models, age [1.06 (1.01-1.12 y)], admission to ICU [6.37(1.27-31.9)], and anticoagulation use [6.95 (1.57-30.6)] were associated with increased mortality. Initial Hb [0.68 (0.51-0.92)] and nadir Hb [0.48 (0.29-0.78)] inversely predicted mortality. CONCLUSIONS: These results suggest that transfusion-free management of gastrointestinal hemorrhage can be effective with mortality comparable with the general population accepting medically indicated transfusion. Management of these patients is challenging and requires a dedicated multidisciplinary team approach knowledgeable in techniques of blood conservation.

An update on mortality and morbidity in patients with very low postoperative hemoglobin levels who decline blood transfusion (CME).

BACKGROUND: Severely anemic patients for whom blood transfusion is not an option provide highly valuable information on risks of anemia and alternative management strategies. STUDY DESIGN AND METHODS: This is a retrospective study of consecutive patients at least 18 years old who could not be transfused, had surgery at a patient blood management center between 2003 and 2012, and had at least one hemoglobin (Hb) measurement of not more than 8 g/dL during the postoperative period. The primary outcome measure was mortality, occurring anytime in the period after the surgery until discharge or 30th day after the surgery, whichever was sooner. Postoperative morbidities included the occurrence of any of sepsis, pneumonia, myocardial infarction, deep wound infection, congestive heart failure, and arrhythmia. RESULTS: A total of 293 patients (including 288 who self-identified as "Jehovah's Witness") were eligible and enrolled. The mean ± SD age of the patients was 61.5 ± 16.9 years and 74.1% were female. Overall mortality rate was 8.2% (95% confidence interval [CI], 5%-11.3%). Unadjusted odds ratio (OR) of death per each 1 g/dL decrease in the nadir postoperative Hb was 2.04 (95% CI, 1.52-2.74); OR of death after adjustment for other significant factors (urgency, American Society of Anesthesiology score, and age) was 1.82 (95% CI, 1.27-2.59). CONCLUSION: Our study confirms the previously reported low risk of mortality in upper nadir Hb ranges of 7 to 8 g/dL and much higher risk in lower ranges, albeit the number of patients reaching extremely low Hb levels were lower than previous report, possibly suggestive of improved management strategy of these patients.

Jehovah's Witnesses and cardiac surgery: a single institution's experience.

BACKGROUND: Based on biblical doctrines, patients of the Jehovah's Witness faith refuse allogeneic blood transfusion. Cardiac surgery carries a high risk of blood transfusion, but has been performed in Jehovah's Witnesses for many years. The literature contains information on the outcomes of this cohort, but does not detail the perioperative care of these patients. This article describes a single institution's experience in perioperative care of Jehovah's Witnesses undergoing cardiac surgery. STUDY DESIGN AND METHODS: A chart review of adult Jehovah's Witness patients undergoing cardiac surgery at Duke University between January 2005 and June 2012 was completed. Institutional protocols regarding preoperative erythropoietin (EPO) therapy and intraoperative isovolemic hemodilution are detailed. Patient demographics and use of various blood conservation techniques are described. Hemoglobin (Hb) at various points throughout the perioperative management, hospital length of stay, and mortality are reviewed as indicators of outcome. RESULTS: Forty-five Jehovah's Witness patients underwent cardiac surgery at Duke University Medical Center. Preoperative EPO increased the mean Hb by 1.2 g/dL before surgery. Intraoperative normovolemic hemodilution was used in 37 patients with intraoperative mean nadir Hb of 10.3 g/dL. Antifibrinolytics and desmopressin were commonly used as coagulation adjuncts. Mean cardiopulmonary bypass time was 137 minutes, with mean nadir temperature of 30.5°C. The mean length of hospital stay was 6.2 days, with mean intensive care unit stay of 1.7 days. This cohort had zero 90-day mortality in the perioperative period. CONCLUSIONS: This case series demonstrates that bloodless cardiac surgery can be performed in select patients refusing allogeneic blood transfusion.

Impact of a blood conservation program on 30-day morbidity and mortality: a cohort study.

BACKGROUND: There are little published data on outcomes of blood conservation (BC) patients after noncardiac surgery. The objective of this study was to compare the surgical outcomes of patients enrolled in our BC program with that of the general population of surgical patients. METHODS: BC patients at our institution undergoing various surgical procedures were identified from the 2007-2009 National Surgical Quality Improvement Program database and compared with a cohort of conventional care (CC) patients matched by age, gender, and surgical procedure. Univariate and multiple logistic regression analyses were performed to evaluate 30-d postoperative outcomes. RESULTS: One hundred twenty BC patients were compared with 238 CC patients. The two groups were similar for all preoperative variables except smoking, which was lower in the BC group. On univariate analysis, BC patients had similar mean operating time (148 versus 155 min; P = 0.5), length of stay (5.9 versus 5.5 d; P = 0.7), and rate of return to the operating room (7.5% versus 5.5%; P = 0.4) compared with CC patients. BC and CC patients had similar 30-d morbidity (18% versus 14%; P = 0.3) and mortality rates (1.6% versus 1.3%; P = 1.0), respectively. On multivariable analysis, enrollment in the BC program had no impact on postoperative 30-d morbidity (odds ratio, 1.78; 95% confidence interval, 0.71-4.47) or 30-d mortality (unadjusted odds ratio, 1.33; 95% confidence interval, 0.22-8.05). CONCLUSIONS: Short-term postoperative outcomes in BC patients are similar to the general population, and these patients should not be denied surgical treatment based on their unwillingness to receive blood products.

Eight-year experience of bloodless surgery at a tertiary care hospital in Korea.

BACKGROUND: The Soonchunhyang University Hospital Bloodless Center was established in 2000, and more than 2000 bloodless surgeries has been performed there since. This study was carried out to analyze the characteristics of patients who underwent bloodless surgery and the influences of postoperative lowest hemoglobin level (H(blow)) along with the lowest postoperative Hb/preoperative Hb ratio (H(blow/pre)) on successful completion of bloodless surgery. STUDY DESIGN AND METHODS: A total of 1407 patients were included. Patients were divided according to H(blow) into not more than 7 and more than 7 g/dL groups and compared regarding use of transfusion alternatives, coexisting risk factors, and mortality rate. They were also grouped as H(blow/pre) of not more than 0.5 or more than 0.5, and mortalities were compared between them. RESULTS: Jehovah's Witnesses comprised 1323 (94.0%) of the total population. The frequency of simultaneous use of erythropoietin and iron was significantly higher in H(blow) of not more than 7 group than in more than 7 g/dL group, as was the use of hemostatics. Among risk factors urging transfusion, the frequencies of cardiovascular disease and cerebrovascular accident were higher in H(blow) of not more than 7 than in the more than 7 g/dL group. Mortality rates in H(blow) of not more than 7 g/dL and H(blow/pre) of not more than 0.5 groups were significantly higher than those in H(blow) of more than 7 g/dL and H(blow/pre) of more than 0.5 groups, respectively. CONCLUSION: We have provided an effective bloodless surgery program for the past 10 years. A prospective multicenter study with other bloodless centers in Korea concerning mortality rates, actual operative blood loss, and postoperative complications in high-risk group of patients would be needed to establish evidence-based guidelines for bloodless surgery.

Short-term outcome of cardiac surgery under cardiopulmonary bypass in patients who refuse transfusion: a controlled study.

BACKGROUND: Although bloodless cardiac surgery has been successfully performed for many years, studies with controls permitting transfusion are few and their results inconclusive. This study compares the outcome of cardiac surgery on Jehovah's Witnesses (JW) refusing transfusion, with that of controls permitting transfusion if required. METHODS: Data from 172 operations in 162 JW were compared with 172 matched controls. Risk factors, preoperative, operative, 48 hour postoperative variables, outcome data and transfusions were recorded. RESULTS: Preoperative and operative variables were similar in both groups except for more previous cardiac operations, and more frequent use of cell saver and aprotinin in JW, who bled less and had higher hemoglobin concentrations at all periods. Thirty-day mortality was higher in JW (9.9% vs. 3.5%; P=0.03) (Risk difference 6.4%; CI95%: 2.7-10.1). Nevertheless operative mortality was similar in both groups (9.9% vs. 7.6%; P=0.44). Mortality in low-risk subjects was higher in JW (8.9% vs. 1.0%; P=0.02) (Risk difference 7.9%; CI95%: 2.7-13.2). Moreover, death associated with hemorrhage and anemia tended to be more frequent in JW. Mortality of transfused controls (14.1%) and their matched JW (13.0%) was similar. In contrast, mortality of non-transfused controls was zero versus 6.3% in their matched JW (P=0.059). CONCLUSIONS: Low-risk JW had significantly higher mortality than controls. Bleeding related deaths tended to be more frequent in JW. Blood-sparing maneuvers should be intensively implemented in both JW and patients permitting transfusion in order to reduce bleeding and the need for transfusion with its harmful effects.

Can maximum surgical blood order schedule be used as a predictor of successful completion of bloodless surgery?

BACKGROUND: The Soonchunhyang University Hospital Bloodless Center was established in 2000, and more than 2,000 bloodless surgeries have been performed there since. In this study, the lowest postoperative Hb/preoperative Hb (Hblow/pre) ratio and mortality rates of patients who underwent bloodless surgery were analyzed for each maximum surgical blood order schedule (MSBOS) category to assess whether MSBOS can be used as a predictor of successful completion of bloodless surgery. METHODS: A total of 971 patients were included. MSBOS was defined as the average number of units of RBCs transfused during each elective surgery. We used the Hblow/pre ratio as an alternative to intraoperative blood loss. Frequency of Hblow/pre ratios ≤0.5, use of transfusion alternatives, and mortality rates were compared across MSBOS categories. RESULTS: Out of the 971 patients, 701 (72.2%) were categorized as type and screen (T&S), 184 (18.9%) as MSBOS 1, 64 (6.6%) as MSBOS 2, and 22 (2.3%) as MSBOS 4. Transfusion alternatives were used by 397 (40.9%) patients. The frequency of the use of simultaneous erythropoietin and iron, hemostatics, acute normovolemic hemodilution, and Cell Saver (Haemonetics corp., USA) was higher in patients in the higher MSBOS categories. Six (0.6%) patients died within 30 days of surgery. Hblow/pre ratios tended to be lower as the level of MSBOS category increased. CONCLUSIONS: Surgeries in the higher MSBOS categories tended to be associated with high blood loss and mortality. Active use of transfusion alternatives is recommended in patients in high MSBOS categories who are scheduled to undergo bloodless surgery.

Should Jehovah's Witness patients be listed for heart transplantation?

This best evidence topic in Cardiac Surgery was written according to a structured protocol. The question addressed was: for [Jehovah's Witness patients with end-stage heart failure] can these patients undergo a [heart transplantation] without an increased rate of mortality. Altogether, 133 papers were found using the reported search strategy. Of those, 29 papers represented the best evidence to answer the clinical question. Five papers focusing on patients of the Jehovah's Witness (JW) faith who had end-stage heart failure were published. Successful heart transplantation was performed in a total of seven patients without mortality, re-exploration or blood transfusion. One patient had left ventricular reduction surgery twice and another patient had bypass surgery several years after transplantation. Other successful organ transplantations were also reported, including lung, liver, kidney and pancreas in both adult and paediatric patients of the JW faith, with comparable mortality and morbidity to non-JW patients. A publication bias is likely; nevertheless, we conclude that although there are no large studies directly focused on heart transplantation in JW patients, a multidisciplinary team approach to such surgery can make it technically feasible and without an increased mortality risk in suitable candidates. Therefore, such patients may be considered for heart transplantation under selected and favourable circumstances.