Objective: We examined intraoperative microembolic signals (GME), inflammatory response, hemolysis, perioperative regional cerebral oxygen saturation (rSO2), myocardial protection and desorbed protein amount on oxygenator fibers in high-risk patients undergoing coronary revascularization (CABG) with minimized and conventional cardiopulmonary bypass (CPB). Methods: Over a ten-month period, 40 Euroscore 6+ patients undergoing CABG were prospectively randomized to one of the two perfusion protocols (N=20): Group 1: minimized extracorporeal circuits (Mini-CPB) (ROCsafe MPC, Terumo, Ann Arbor, MI, USA) and Group 2: conventional extracorporeal circuits (CECC) (Capiox SX18, Terumo, USA). Serum creatinine kinase-MB (CKMB), free hemoglobin, interleukin-6 (IL-6) and C3a levels were measured. Blood samples were collected at T1: following induction of anesthesia; T2: thromboelastography control; T3:15 min after commencement of CPB; T4: before cessation of CPB; T5: 15 min after protamine reversal and T6: ICU. Results: Serum IL-6 levels were significantly lower in the Mini-CPB group at T4 and T5 and C3a levels were significantly less in the Mini-CPB group at T3, T4 and T5 vs. CECC (p<0.01). CKMB levels in coronary sinus blood demonstrated well preserved myocardium in the Mini-CPB group. Percentage expression of neutrophil CD11b/CD18 levels were significantly lower in the Mini-CPB group at T4 and T5 (p<0.05). There were no significant differences in air handling characteristics or free plasma hemoglobin levels in either circuit. rSO2 measurements were significantly better at T3 and T4 in the Mini-CPB vs. CECC (p<0.05) and always higher in the Mini-CPB during follow-up. Blood protein adsorption analysis of oxygenator membranes demonstrated a significantly increased amount of microalbumin on CECC fibers (p<0.05). Conclusion: Mini-CPB provided a comfort and safety level similar to conventional control via satisfactory air handling, attenuated inflammatory response and hemodilution, with a better clinical outcome in patients undergoing high-risk CABG.
The landmark 2016 Minimal Invasive Extracorporeal Technologies International Society (MiECTiS) position paper promoted the creation of a common language between cardiac surgeons, anesthesiologists and perfusionists which led to the development of a stable framework that paved the way for the advancement of minimal invasive perfusion and related technologies. The current expert consensus document offers an update in areas for which new evidence has emerged. In the light of published literature, modular minimal invasive extracorporeal circulation (MiECC) has been established as a safe and effective perfusion technique that increases biocompatibility and ultimately ensures perfusion safety in all adult cardiac surgical procedures, including re-operations, aortic arch and emergency surgery. Moreover, it was recognized that incorporation of MiECC strategies advances minimal invasive cardiac surgery (MICS) by combining reduced surgical trauma with minimal physiologic derangements. Minimal Invasive Extracorporeal Technologies International Society considers MiECC as a physiologically-based multidisciplinary strategy for performing cardiac surgery that is associated with significant evidence-based clinical benefit that has accrued over the years. Widespread adoption of this technology is thus strongly advocated to obtain additional healthcare benefit while advancing patient care.
Background: This study aimed to determine whether there was any association between the intensity of intraoperative gaseous microembolic signals (GME), neuropsychological testing and clinical outcome in high-risk patients undergoing coronary artery surgery (CABG). Methods: Over a 6-month period, GME activity was monitored in 102 Euroscore 6+ patients during cardiopulmonary bypass (CPB) with a conventional 32-micron arterial filter by non-invasive, real-time ultrasonic device. Cognitive tests; line bisection, the Stroop test, finger tapping, and the Rey Auditory Verbal Learning Test were performed at baseline, postoperative one week and postoperative one month. Results: The distribution of GME activity showed that there were three groups of patients: >500 total emboli (n = 38); 250 to 500 emboli (n = 30) and 500 emboli patients versus control (<250 emboli) in postoperative week one, but resolved in one month. Conclusions: Correlation between intraoperative GME intensity and neurocognitive tests suggests that the level of GME might have a role in determining the psychological outcome after CABG with CPB.
Coating of extracorporeal circuits may be a solution to prevent adverse effects induced by the contact of blood elements and proteins with foreign surfaces. This paper reviews the recent novel coating technologies and compares their documented in vitro and ex vivo advantages under the clinical setting. Data presented have also been supported by postclinical biomaterial research to verify biocompatibility and hemocompatibility.
We compared the clinical efficacy of autologous platelet gel (APG) and gelatine (CONT), including biomaterial evaluation. In a prospective, randomized, controlled trial, 64 patients undergoing complex coronary artery bypass graft (CABG) surgery and/or aortic surgery, in whom the surgeon was able to identify a bleeding site for which conventional means to stop bleeding were impractical or proved unsuccessful, were enrolled. Aortic punch biopsy from each patient was harvested in explant cell (EC) culture media. Hemostasis success for the “oozing” category was 89% in APG and 60% in CONT (p< 0.05). For the “heavy bleeding” category, the success rates were 92% in APG and 45% in CONT (p<0.01). Contact of gelatine inhibited EC proliferation and APG increased cell cycling and EC quantity. Phagocytic capacity (PC) was significantly higher in the APG group (p<0.001). APG was significantly better than CONT with respect to hemostatic success rate, effects on wound healing and increased resistance to infection (PC).
Introduction: The trial hypothesized that minimally invasive extra-corporeal circulation (MiECC) reduces the risk of serious adverse events (SAEs) after cardiac surgery operations requiring extra-corporeal circulation without circulatory arrest. Methods: This is a multicentre, international randomized controlled trial across fourteen cardiac surgery centres including patients aged ≥18 and <85 years undergoing elective or urgent isolated coronary artery bypass grafting (CABG), isolated aortic valve replacement (AVR) surgery, or CABG + AVR surgery. Participants were randomized to MiECC or conventional extra-corporeal circulation (CECC), stratified by centre and operation. The primary outcome was a composite of 12 post-operative SAEs up to 30 days after surgery, the risk of which MiECC was hypothesized to reduce. Secondary outcomes comprised: other SAEs; all-cause mortality; transfusion of blood products; time to discharge from intensive care and hospital; health-related quality-of-life. Analyses were performed on a modified intention-to-treat basis. Results: The trial terminated early due to the COVID-19 pandemic; 1071 participants (896 isolated CABG, 97 isolated AVR, 69 CABG + AVR) with median age 66 years and median EuroSCORE II 1.24 were randomized (535 to MiECC, 536 to CECC). Twenty-six participants withdrew after randomization, 22 before and four after intervention. Fifty of 517 (9.7%) randomized to MiECC and 69/522 (13.2%) randomized to CECC group experienced the primary outcome (risk ratio = 0.732, 95% confidence interval (95% CI) = 0.556 to 0.962, p = 0.025). The risk of any SAE not contributing to the primary outcome was similarly reduced (risk ratio = 0.791, 95% CI 0.530 to 1.179, p = 0.250). Conclusions: MiECC reduces the relative risk of primary outcome events by about 25%. The risk of other SAEs was similarly reduced. Because the trial terminated early without achieving the target sample size, these potential benefits of MiECC are uncertain.