Pulsatile-flow mechanical circulatory support (MCS) as a bridge to transplantation or recovery. Single-centre experience with the POLCAS system in 2014

Abstract

IntroductionMechanical circulatory support (MCS) is a recognised method of treatment for patients with end-stage chronic or acute heart failure. The POLCAS pulsatile-flow system has been used in our institution for 15 years. Currently, it is being widely replaced by continuous-flow mechanical circulatory support equipment of the second and third generations (HeartMateII, HeartWare). The MCS presented in this study is associated with a significant risk of complications and its use is increasingly considered controversial. The aim of the study was an evaluation of the results of treatment utilising the POLCAS MCS system at our institution in 2014.Material and methodsThe POLCAS system was implanted in 12 patients aged 16-63 years (42 ± 17 years) during a period of 12 months (from January to December, 2014). Full-blown cardiogenic shock was observed in all patients before MCS implantation. Four of the analysed patients (33%) required prior circulatory support with other devices: IABP (n = 2) or ECMO (n = 2). Episodes of cardiac arrest were reported in three patients; three other patients experienced serious arrhythmias, which accelerated the decision to implant MCS. The presented data was retrospectively obtained from the CliniNET system of the Institute of Cardiology. OpenOffice Calc spreadsheet was used for data analysis.ResultsAverage MCS time was 41 days ± 25 (from 15 to 91 days). Survival until transplantation or explantation was 91.67%. The most frequent complications following the therapy were: cardiac tamponade or bleeding requiring an intervention – 25% (n = 3), renal failure requiring dialysis – 25% (n = 3), ischaemic stroke associated with the MCS – 16.6% (n = 2), bacteraemia – 16.6% (n = 2), and wound infection – 8% (n = 1). No malfunctions of the MCS system were reported. Early survival in patients who completed the MCS therapy, defined as discharge, amounted to 63.6% (n = 7).ConclusionsThe POLCAS heart assist system is an effective method of treatment as a bridge to transplantation or recovery in patients with end-stage heart failure. Early survival after the treatment remains at a satisfactory level. The main problem is the large number of complications related to the therapy.

Forming effective relationships between academia and the medical devices industry with a focus on launching a smart heart valve prosthesis for pediatric patients

“…However, this is a very fresh initiative, and only after 25 years of the FCSD operation there is a need to contact and cooperate with LMDMs. The details of these interactions are shrouded in trade secrets, but it is obvious that the foundation's position is built on hundreds of lives saved [54,55], over 40 patents [56], and hundreds of scientific publications [51,52]. Even despite such achievements, contacting LMDMs is not easy.…”

“…The FCSD gains experience in this field. The three flagship medical products developed by the FCSD include extracorporeal heart assist pumps [54,55,57], valvular homografts [58], and surgical robots [59][60][61][62][63][64]. So far, over 1000 extracorporeal heart assist pumps have been created.…”

“…The financing of the pumps was carried out by the FCSD and its subsidiary company, Intracordis, on a nonprofit basis as part of a medical procedure financed by the Polish Ministry of Health. However, these devices were used to saving lives [54,55,57,[65][66][67][68] and have been used in 6 major cardiac surgery centres in Poland [30]. Recently, the mechanical extracorporeal heart assist systems POLAVAD and POLCAS have changed their brand name to ReligaHeart.…”

Mechanical circulatory support in heart failure

“…Depending on the planned duration of circulatory support, the following can be distinguished: – short-term circulatory support (up to 7 days) provided by rotary pumps supporting the functioning of the right or left ventricle and extracorporeal membrane oxygenation (ECMO) systems [ 10 ]; – medium-term circulatory support (from 7 days to 3 months) provided by pulsatile pumps (POLCAS, ABIOMED) and some centrifugal pumps [ 4 ]; – long-term circulatory support (several months or years) provided by left ventricular or biventricular assist devices (LVAD, BiVAD) using continuous flow (HeartMate II, Thoratec, and HeartWare) or pulsatile flow (Novacor LVAD). …”

“…– medium-term circulatory support (from 7 days to 3 months) provided by pulsatile pumps (POLCAS, ABIOMED) and some centrifugal pumps [ 4 ];…”