Two Years of Experience in the Implantation of Heartmate III.

INTRODUCTION: Left ventricular assist devices as long-term mechanical circulatory support are increasingly used as an option for medically refractory advanced heart failure. Heartmate III is one of the alternative devices for circulatory support in those patients. OBJECTIVES: Analyze a two years Heartmate III implantation Program. METHODS: From November 2015 to August 2017, Heartmate III was implanted in 16 patients with chronic end-stage heart failure, in 81% (n = 13) as a bridge to transplant and 19% (n = 3) as destination therapy. We did a review off demographic, clinical and surgical data, and we analyzed the overall survival using the Kaplan-Meier method, excluding patients who were transplanted. RESULTS: Heartmate III was implanted in 16 male patients (100%) with age 55.8 ± 11.1 years (limits 38-74 years) and body surface area 2.0 ± 0.19 m2. The baseline hemodynamic data revealed a cardiac index 2.1 ± 0.4 l / min / m2 and a left ventricular ejection fraction of 20.7 ± 7.3%. Ischemic cardiomyopathy was the most common etiology in this chronic heart failure population (n = 9; 56%). Seven patients (44%) were classified INTERMACS 4; five (31%) in profile 2; three (19%) in profile 3 and one (6%) in profile 1. The implantation of the devices was performed under Cardiopulmonary Bypass (78.6 ± 25.7 min), and 25% of the patients (n = 4) had right ventricular dysfunction, requiring postoperative temporary right ventricle support. As complications, 6 patients (38%) manifested bleeding requiring surgery and 2 (12%) reported gastrointestinal bleeding, 4 (25%) developed driveline infection, 3 of them were treated (18%) with conservative therapy and in 1 patient (6%) with driveline transposition. During the total follow-up time (19 months), three patients (18%) were transplanted; two deaths occured due to pulmonary embolism and ischemic stroke respectively; verified by the Kaplan Meier method, an overall survival rate of 92.9 ± 6.9%, stable from 6 months after implantation. CONCLUSION: The 6 months survival rate of 92.9% proves the efficacy of this therapy for our patients and all of them were INTERMACS profils lower than 4. Despite the small number of patients enrolled and the follow-up duration limiting our study, we demonstrated the first experience of our center in the treatment of high-risk population. In conclusion, we show that the Heartmate III was consistent in low INTERMACS profile patients.

Validation of rotational thromboelastometry during cardiopulmonary bypass: A prospective, observational in-vivo study.

BACKGROUND: Rotational thromboelastometry (ROTEM) is a whole blood point-of-test used to assess the patient's coagulation status. Three of the available ROTEM tests are EXTEM, INTEM and HEPTEM. In the latter, heparinase added to the INTEM reagent inactivates heparin to reveal residual heparin effect. Performing ROTEM analysis during cardiopulmonary bypass (CPB) might allow the anaesthesiologist to anticipate the need for blood products. OBJECTIVE: The goal of this study was to validate ROTEM analysis in the presence of very high heparin concentrations during CPB. DESIGN: Prospective, observational trial. SETTING: Single University Hospital. PARTICIPANTS: Twenty patients undergoing coronary artery bypass grafting. MAIN OUTCOME MEASURE: ROTEM analysis was performed before heparin administration (T0), 10 min after heparin (T1), at the end of CPB (T2) and 10 min after protamine (T3). The following tests were performed: EXTEM, INTEM, and HEPTEM. Heparin concentrations were measured at T1 and at the end of bypass (T2). RESULTS: At T1, EXTEM differed from baseline for coagulation time: +26.7 s (18.4 to 34.9, P < 0.0001), α: -3° (1.0 to 5.4, P = 0.006) and A10: -4.4 mm (2.3 to 6.5, P = 0.0004). INTEM at T0 was different from HEPTEM at T1 for coagulation time: + 47 s (34.3 to 59.6, P > 0.0001), A10: -2.3 mm (0.5 to 4.0, P = 0.01) and α -2° (1.0 to 3.0; P = 0.0007). At T2, all parameters in EXTEM and HEPTEM related to fibrin-platelet interaction deteriorated significantly compared to T1. At T3, EXTEM and INTEM were comparable to EXTEM and HEPTEM at T2. CONCLUSION: HEPTEM and EXTEM measurements are valid in the presence of very high heparin concentrations and can be performed before protamine administration in patients undergoing cardiac surgery with CPB. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01455454.

Superior venous drainage in the "LifeBox": a portable extracorporeal oxygenator with a self-expanding venous cannula.

BACKGROUND: In an experimental setting, the performance of the LifeBox, a new portable extracorporeal membrane oxygenator (ECMO) system suitable for patient transport, is presented. Standard rectilinear percutaneous cannulae are normally employed for this purpose, but have limited flow and pressure delivery due to their rigid structure. Therefore, we aimed to determine the potential for flow increase by using self-expanding venous cannulae. METHODS: Veno-arterial bypass was established in three pigs (40.6+/-5.1 kg). The venous line of the cardiopulmonary bypass was established by cannulation of the external jugular vein. The arterial side of the circulation was secured by cannulation of the common carotid artery. Two different venous cannulae (SmartCanula 18/36F 430mm and Biomedicus 19F) were examined for their functional integrity when used in conjunction with the centrifugal pump (500-3000 RPM) of the LifeBox system. RESULTS: At 1500, 2000, 2500, and 3000 RPM, the blood flow increased steadily for each cannula, but remained higher in the self-expanding cannula. That is, the 19F rectilinear cannula achieved a blood flow of 0.93+/-0.14, 1.47+/-0.37, 1.9+/-0.68, and 1.5+/-0.9 l/min, respectively, and the 18/36F self-expanding cannula achieved 1.1+/-0.1, 1.9+/-0.33, 2.8+/-0.39 and 3.66+/-0.52 l/min. However, when tested for venous line pressure, the standard venous cannula achieved -29+/-10.7mmHg while the self-expanding cannula achieved -13.6 +/-4.3mmHg at 1500 RMP. As the RPM increased from 2500 to 3000, the venous line pressure accounted for -141.9+/-20 and -98+/-7.3mmHg for the 19F rectilinear cannula and -30.6+/-6.4 and -45+/-11.6mmHg for the self-expanding cannula. CONCLUSION: The self-expanding cannula exhibited superior venous drainage ability when compared to the performance of the standard rectilinear cannula with the use of the LifeBox. The flow rate achieved was approximately 40% greater than the standard drainage device, with a maximal pump flow recorded at 4.3l/min.