Hemolytic Performance in Two Generations of the Sputnik Left Ventricular Assist Device: A Combined Numerical and Experimental Study

Background: Currently, left ventricular assist devices (LVADs) are a successful surgical treatment for patients with end-stage heart failure on the waiting list or with contraindicated heart transplantation. In Russia, Sputnik 1 LVAD was also successfully introduced into clinical practice as a bridge-to-transplant and a destination therapy device. Development of Sputnik 2 LVAD was aimed at miniaturization to reduce invasiveness, optimize hemocompatibility, and improve versatility for patients of various sizes. Methods: We compared hemolysis level in flow path of the Sputnik LVADs and investigated design aspects influencing other types of blood damage, using predictions of computational fluid dynamics (CFD) and experimental assessment. The investigated operating point was a flow rate of 5 L/min and a pressure head of 100 mm Hg at an impeller rotational speed of 9100 min−1. Results: Mean hemolysis indices predicted with CFD were 0.0090% in the Sputnik 1 and 0.0023% in the Sputnik 2. Averaged values of normalized index of hemolysis obtained experimentally for the Sputnik 1 and the Sputnik 2 were 0.011 ± 0.003 g/100 L and 0.004 ± 0.002 g/100 L, respectively. Conclusions: Obtained results indicate obvious improvements in hemocompatibility and sufficiently satisfy the determined miniaturization aim for the Sputnik 2 LVAD development.

Impact of Right Heart Failure on Clinical Outcome of Left Ventricular Assist Devices (LVAD) Implantation: Single Center Experience

The aim of this study was to examine the incidence and significance of right heart failure (RHF) in the early and late phase of left ventricular assist device (LVAD) implantation with the identification of predictive factors for the development of RHF. This was a prospective observational analytical cohort study. The study included 92 patients who underwent LVAD implantation and for whom all necessary clinical data from the follow-up period were available, as well as unambiguous conclusions by the heart team regarding pathologies, adverse events, and complications. Of the total number of patients, 43.5% died. The median overall survival of patients after LVAD implantation was 22 months. In the entire study population, survival rates were 88.04% at one month, 80.43% at six months, 70.65% at one year, and 61.96% at two years. Preoperative RHF was present in 24 patients, 12 of whom died and 12 survived LVAD implantation. Only two survivors developed early RHF (ERHF) and two late RHF (LRHF). The most significant predictors of ERHF development are brain natriuretic peptide (BNP), pre-surgery RHF, FAC < 20%, prior renal insufficiency, and total duration of ICU stay (HR: 1.002, 0.901, 0.858, 23.554, and 1.005, respectively). RHF following LVAD implantation is an unwanted complication with a negative impact on treatment outcome. The increased risk of fatal outcome in patients with ERHF and LRHF after LVAD implantation results in a need to identify patients at risk of RHF, in order to administer the available preventive and therapeutic methods.

Manual Compression Versus MANTA Device for Access Management After Impella Removal on the ICU

Objective: To compare the safety and efficacy of manual compression versus use of the MANTA® closure device for access management after Impella® removal on the intensive care unit (ICU).Background: The number of patients treated with percutaneous left ventricular assist devices (pLVAD), namely Impella® and ECMO, for complex cardiac procedures or shock, is growing. However, removal of pLVAD and large bore arteriotomy closure among such patients on the ICU remains challenging, since it is associated with a high risk for bleeding and vascular complications. Methods: Patients included in a prospective registry between 2017 and 2020 were analyzed. Bleeding and vascular access site complications were assessed and adjudicated according to VARC-2 criteria. Results: We analyzed a cohort of 87 consecutive patients, who underwent access closure after Impella® removal on ICU by using either the MANTA® device or manual compression. The cohort´s mean age was 66.1±10.7 years and 76 patients (87%) were recovering from CS. Mean support time was 40 hours (Interquartile range 24–69 hours). MANTA® was used in 31 patients (35.6%) and manual compression was applied in 56 patients (64.4%). Overall access related bleedings were significantly lower in the MANTA® group (6.5% versus 39.3%(odds ratio (OR) 0.10, 95% CI 0.01–0.50; p=0.001), and there was no significant difference in vascular complications between the two groups(p=0.55).Conclusions: Our data suggests that the application of the MANTA® device directly on the ICU is safe. In addition, it seems to reduce access related bleeding without increasing the risk of vascular complications.

Destination left ventricular assist devices in island states: asking too much or the inevitable solution

Background Destination left ventricular assist device placement is increasing as a result of donor shortages and changing patient attitudes. As organ shortages become critical, LVAD programs become fundamental even in more remote regions of the world including island states. Here, we provide a look into the current state and availability of LVAD programs in island states. Main body A narrative review was performed using the World Health Organization Global Index Medicus and PubMed/MEDLINE databases to identify articles describing the island states having reported LVAD placements and programs. Additionally, INTERMACS reports were used. Data were retrieved and a review is presented describing the current state of LVADs in island states. The Caribbean region as a whole has a heart failure (HF) prevalence of 814 per 100,000 and Oceania 667 per 100,000 people. We estimate that over 3000 people in these islands need either a heart transplant or an LVAD. Short conclusion For HF patients living in island regions, special attention should be paid to the inability of having access to specialized mainland medical care. The continuous quest for a solution to HF in island regions should include the establishing of high-quality LVAD programs in a transfer-network centralized/regionalized system to care for those patients not candidates for long-distance air-bridging.