First Clinical Experience With the Pressure Sensor-Based Autoregulation of Blood Flow in an Artificial Heart.

The CARMAT-Total Artificial Heart (C-TAH) is designed to provide heart replacement therapy for patients with end-stage biventricular failure. This report details the reliability and efficacy of the autoregulation device control mechanism (auto-mode), designed to mimic normal physiologic responses to changing patient needs. Hemodynamic data from a continuous cohort of 10 patients implanted with the device, recorded over 1,842 support days in auto-mode, were analyzed with respect to daily changing physiologic needs. The C-TAH uses embedded pressure sensors to regulate the pump output. Right and left ventricular outputs are automatically balanced. The operator sets target values and the inbuilt algorithm adjusts the stroke volume and beat rate, and hence cardiac output, automatically. Auto-mode is set perioperatively after initial postcardiopulmonary bypass hemodynamic stabilization. All patients showed a range of average inflow pressures of between 5 and 20 mm Hg during their daily activities, resulting in cardiac output responses of between 4.3 and 7.3 L/min. Operator adjustments were cumulatively only required on 20 occasions. This report demonstrates that the C-TAH auto-mode effectively produces appropriate physiologic responses reflective of changing patients' daily needs and represents one of the unique characteristics of this device in providing almost physiologic heart replacement therapy.

Successful heart transplantation after 17 h ex vivo time using the Organ Care System-3 years follow-up.

Cold storage preservation is the standard approach for heart transplantation but is a time-limited method of care. Ex vivo heart perfusion expands the donor pool due by mitigating time and distance barriers and allows the possibility to improve graft function. We report long term follow up of a successful heart transplantation following an ex vivo time of 17 h using the Organ Care System in a patient with a left ventricular assist device.

Heart transplantation of patients with ventricular assist devices: impact of normothermic ex-vivo preservation using organ care system compared with cold storage.

BACKGROUND: Organ Care System (OCS) minimizes the cold ischemic time and allows for optimization of logistics and meticulous recipient preparation. Impact of normothermic ex-vivo preservation using OCS compared with cold storage (CS) for prolonged heart preservation especially beneficial for high-risk recipients bridged to transplantation with Mechanical Circulatory Support (MCS). METHODS: Between 2012 and 2018, we performed a retrospective single-center review of prospectively collected data. All patients who underwent heart transplantation with MCS using the OCS Heart (n = 25) versus standard cold storage (n = 10) were included in this study. RESULTS: During this period, 353 patients were implanted with left ventricular assisted device (LVAD) and 35 (10%) were bridged to heart transplantation. There was no significant difference in donor and recipient characteristics and risk factors. The Index for Mortality Prediction after Cardiac Transplantation (IMPACT) score was a trend towards higher estimated risk of death at 1y in the OCS group (14.2 vs. 10.8% p = 0.083). Mean total ischemic time during preservation was statistically significantly longer in CS vs OCS group (210 (23) Vs 74.6 (13) min p = 0.001). Median ex vivo normothermic heart perfusion time in OCS was 348.4(132; 955) min. There was significant difference in total out of body time between OCS group 423(67) Vs CS group 210(23) min p = 0.002). All patients were alive on the 30th days post implant in CS groups and 96% in OCS group (p = 0.5). CONCLUSION: Normothermic ex-vivo preservation of the allograft during transportation with the organ care system might be beneficial for long-time out of body organ preservation in comparison of cold storage especially for recipients on mechanical circulatory support.

Left Ventricular Assist Device Outflow Graft Pseudoaneurysm Treated with Covered Balloon Expandable Stent.

Left ventricular assist device (LVAD) outflow graft injury is a very rare complication after LVAD implantation and is usually treated surgically. This is a case report of successful stenting of the damaged outflow graft 2.5 years after LVAD implantation, followed by successful heart transplantation.

Comparison of Custodiol vs warm blood cardioplegia and conditioning of donor hearts during transportation with the organ care system.

OBJECTIVES: Cold crystalloid cardioplegia for donor heart harvesting and cold ischemic storage conditions during the transportation is the standard of care during heart transplantation procedure. Organ care system (OCS) was introduced for more prolonged and reliable ex vivo organ management. This study evaluated the two different techniques used for myocardial preservation during the procurement and transportation of the heart using the OCS. METHODS: We performed prospective analysis of 43 patients with heart failure undergoing heart transplantation and using the OCS for donor organ transport. Donor hearts were arrested using blood cardioplegia and conditioning (n = 30) or standard Custodiol (SC) solution ( n = 13). Perfusion and cardiac function parameters were continuously monitored while the donor hearts were perfused in the OCS. Impact of preservation techniques on biochemical parameters and clinical outcomes were evaluated. RESULTS: All donor hearts had stable perfusion and lactate characteristics in the OCS, with similar measures between the two groups at the beginning of the ex vivo perfusion. Ex vivo heart perfusion mean ending concentration of Interleukin (IL)-6 and IL-8 was significantly lower in the blood cardioplegia group compared to the standard care group. Clinical outcomes were comparable between the two groups of patients. CONCLUSIONS: The use of blood cardioplegia and conditioning could be a safe method for myocardial protection in distant procurement and preservation of donor hearts in the OCS.

Initial 3-year outcomes with left ventricular assist devices in a country with a nascent heart transplantation program.

AIMS: The need for the left ventricular assist devices (LVAD) in patients with end-stage heart failure is well established, but prior to 2011, this was not available to patients in Kazakhstan. We describe the development of the sole LVAD programme in the context of a nascent heart transplantation programme and clinical outcomes for the first three years. METHODS AND RESULTS: From November 2011 to November 2014, 146 patients underwent implantation of 152 VADs (approximately 50 devices implanted per year). We retrospectively analyzed data from 135 LVAD patients who received HeartMate II (n = 95) or HeartWare (n = 40) devices. In 75 patients LVAD was used as a bridge-to-transplantation and in 60 patients as destination therapy, but only 3 of 135 LVAD patients received heart transplant. Forty-three patients of the LVAD cohort had died by the end of the follow-up period. The mean time on LVAD was 466 ± 330 days (range 5-1200 days). Kaplan-Meier survival estimates for patients who continued on LVAD support were 93% after 1 month, 86% after 6 months and 77% after 12 months. The most common complications within the first 30 days after implant included right ventricular failure (n = 20, 1.85 events/patient-year), renal failure (n = 19, 1.76 events/patient-year) and bleeding (n = 33, 3.0 events/patient-year). Beyond 30 days adverse events included driveline infections (n = 46, 0.56 events/patient-year) and stroke (n = 33, 0.21 events/patient-year). CONCLUSIONS: LVADs are an important therapeutic alternative to heart transplantation in the context of a developing heart transplant programme with outcomes that are comparable to those reported by other centres.

[Surgical heart failure treatment program - the experience of Kazakhstan]. / Programma chirurgico per il trattamento dell'insufficienza cardiaca - l'esperienza del Kazakhstan.

In Kazakhstan, geographical and cultural reasons do not favor the development of heart transplant activity. Thus, a surgical program for treatment of advanced, refractory heart failure was implemented, focusing the efforts on ventricular assist device (VAD) therapy. The program, supported and funded by the national healthcare system, is based on a single, highly specialized surgical Center for the operation, and on a regional infrastructure for outpatient follow-up. Regional VAD coordinators are educated by the National Center. They are in charge of regular patient check, anticoagulant and antiplatelet treatment prescription, and continuing patients' and caregivers' education, mainly regarding driveline exit site dressing and driveline stabilization. From November 2011 to November 2013, 95 patients received 100 devices, mainly for left ventricular support (LVAD): HeartMate II, n=70, HeartWare, n=25. Mean age was 49.5 years, and 87.37% of the patients were males. Most patients had INTERMACS profile 4 (55%), followed by 3 and 2 (17% each). Symptomatic and functional improvement are testified by changes from baseline to month 3 of NYHA functional class (from III-IV to I-II), results of the 6-min walk test (from 152 to 440 m), and NT-proBNP levels (from 6997 to 1126 pg/ml). Overall 1-year survival was 69%, with a trend for outcome improvement over time and a relationship with preoperative INTERMACS profile (1-year survival of 60% in patients with INTERMACS profile 1-2 vs 75% in those with INTERMACS profile 3-4). In summary, where and when a heart transplant program cannot be implemented, LVAD represents a realistic therapeutic alternative. The key points for a successful VAD program are a dedicated, highly specialized multidisciplinary team at the Cardiac Surgery Center, an infrastructure throughout the country for coordinated outpatient follow-up, adequate reimbursement for this activity, and support by the healthcare system.