Efficacy and safety of Impella 5.0 in cardiogenic shock: an updated systematic review

Aim: The impact on safety and efficacy outcomes of Impella 5.0 in cardiogenic shock (CS) has not been systematically assessed. Materials & methods: We conducted a systematic review of the literature (PROSPERO protocol: CRD42020164680) to critically appraise available evidence on Impella 5.0 comparative safety, efficacy and effectiveness. Results: Of 244 retrieved citations, 17 original articles met the a priori defined inclusion criteria. All included studies had a retrospective study design and, overall, reported on, respectively, 52 and 67 different safety and efficacy/effectiveness outcomes. Thirty-day survival rates ranged from 40 to 94%, myocardial recovery from 18 to 93%. Conclusion: Impella 5.0 provides a full cardiac support, it is associated with a lower rate of vascular complications, it represents a valuable bridge-to-decision and allows for resolution of intercurrent clinical conditions. As available data suggest Impella 5.0 good performance in CS of various etiologies, more solid evidence will come from much-needed large-scale all-comer registries and prospective multicenter randomized trials.

Comparison of Impella 5.0 and extracorporeal left ventricular assist device in patients with cardiogenic shock

Introduction: Choice of mechanical circulatory support to stabilize hemodynamics until cardiac recovery or next treatment is a strategic cornerstone for improving outcomes in patients with severe cardiogenic shock. We aimed to clarify the difference in treatment course and outcomes with the use of Impella 5.0 and an extracorporeal left ventricular assist device (eLVAD) in patients with cardiogenic shock refractory to medical therapy or other mechanical circulatory support. Methods: We performed a retrospective medical record review of consecutive patients who were implanted with Impella 5.0 or eLVAD as a bridge to decision at our medical center. Results: A total of 26 patients (median age 40 years, 16 males) were analyzed. Of seven patients managed with Impella 5.0, the Impella 5.0 was removed successfully in two patients and five patients underwent surgery for durable LVAD implantation. Of 19 patients managed with eLVAD, the eLVAD was successfully removed in 3 patients, 9 patients required durable LVAD, and 7 patients died during eLVAD management. The period between Impella 5.0 or eLVAD implantation to durable LVAD surgery was significantly shorter with Impella 5.0 (58 vs 235 days, p = 0.001). Cardiopulmonary bypass time was significantly shorter and a significantly smaller amount of red blood cell transfusion was required with Impella 5.0 (149 vs 192 min, p = 0.042; 7.0 vs 15.0 units, p = 0.019). There were four massive stroke events with eLVAD, but no massive stroke event with Impella 5.0. Conclusion: Impella 5.0 facilitates smoother management as a bridge to decision and reduces surgical invasiveness during durable LVAD implantation.

Outcomes of extracorporeal membrane oxygenation and cardiopulmonary bypass in children after drowning-related resuscitation

Drowning is one of the leading causes of accidental deaths in children worldwide. However, the use of long-term extracorporeal life support (ECLS) in this setting is not widely established, and rewarming is often achieved by short-term cardiopulmonary bypass (CPB) treatment. Thus, we sought to add our experience with this means of support as a bridge-to-recovery or to-decision. This retrospective single-center study analyzes the outcome of 11 children (median 23 months, minimum–maximum 3 months–6.5 years) who experienced drowning and subsequent cardiopulmonary resuscitation (CPR) between 2005 and 2016 and who were supported by veno-arterial extracorporeal membrane oxygenation (ECMO), CPB, or first CPB then ECMO. All but one incident took place in sweet water. Submersion time ranged between 10 and 50 minutes (median 23 minutes), water temperature between 2°C and 28°C (median 14°C), and body core temperature upon arrival in the emergency department between 20°C and 34°C (median 25°C). Nine patients underwent ongoing CPR from the scene until ECMO or CPB initiation in the operating room. The duration of ECMO or CPB before successful weaning/therapy withdrawal ranged between 2 and 322 hours (median 19 hours). A total of four patients (36%) survived neurologically mildly or not affected after 4 years of follow-up. The data indicate that survival is likely related to a shorter submersion time and lower water temperature. Resuscitation of pediatric patients after drowning has a poor outcome. However, ECMO or CPB might promote recovery in selected cases or serve as a bridge-to-decision tool.

Use of Transcarotid IMPELLA 2.5 Axial-Flow Pump Device for Left Ventricle Unloading During VA-ECMO Support in Pediatric Acute Heart Failure

An alternative strategy for left ventricular (LV) venting during short-term mechanical circulatory support is use of Impella axial-flow pump. We present our transcarotid Impella 2.5 implantation technique using a polytetrafluoroethylene graft, in two children with acute heart failure treated primarily with venoarterial ECMO. The venoarterial extracorporeal membrane oxygenator and Impella support were maintained for 5 and 17 days, respectively. Transcarotid Impella implantation might be an alternative and feasible option in pediatrics patients affected by severe LV failure, as a bridge to decision or bridge to candidacy. Potentially, the Impella 2.5 device provides less invasive support for children with heart failure.

Perioperative temporary mechanical circulatory support with Impella in cardiac surgery patients

Background: The benefits of perioperative mechanical circulatory support (MCS) in cardiac surgery patients are still uncertain. This study aims to review early outcomes of perioperative temporary MCS using the Impella device in cardiac surgery patients. Methods: Retrospective, single center analysis in cardiac surgery patients presenting with cardiogenic shock (CS) in whom Impella was used for perioperative temporary MCS, whether as single device therapy or as left ventricular (LV) venting strategy for concomitant extra corporeal membrane oxygenation (ECPELLA). Study outcomes were 30-day mortality and occurrence of complication composite outcome. Results: Between 2016 and 2019, a total of 33 consecutive patients were supported with Impella [single-device therapy in 19 (57.6%) patients and ECPELLA in 14 (42.4%) patients]. The 30-day mortality of Impella-alone and ECPELLA groups was 15.8% and 50.0% (P=0.03).The 30-day mortality according to pre-, intra- and postoperative implantation was 12.5%, 60.0% and 28.6% (P=0.04), and it was significantly lower in those patients in whom a left ventricular assist device was implanted in comparison to all other surgical procedures (P<0.01). The complication composite outcome occurred more frequently after axillary implantation in comparison to femoral Impella (P=0.05) due to higher stroke rates (P=0.03). Bleeding requiring surgical re-exploration was more frequent in the ECPELLA than in the Impella-alone group [1 (3.0%) vs 5 (15.1%);P=0.03]. Conclusions: Temporary MCS with Impella is associated with high complication and mortality rates. However, preoperative use of Impella as single-device temporary MCS is associated with lower mortality rates and is a reasonable alternative as bridge-to-decision strategy for acutely decompensated patients.

Abstract 13425: Comparison Between Impella 5.0 and External Corporeal Left Ventricular Assist Device as a Bridge to Decision in Patients With Cardiogenic Shock

Background: In cardiogenic shock refractory to medical treatment, choosing and changing mechanical circulatory support to stabilize hemodynamics until cardiac recovery or next treatment is a strategic cornerstone for improving the outcome. We aimed to clarify the differences in treatment course and outcome between Impella 5.0 and extracorporeal left ventricular assist device (eLVAD) in patients with cardiogenic shock refractory to medical therapy or other mechanical circulatory support. Methods: We performed a retrospective medical record review of consecutive patients who were treated with Impella 5.0 or eLVAD as a bridge to decision (BTD) at our medical center from December 2011 to January 2020. Results: A total of 26 patients (median age 40 years, 16 males) were analyzed. Of seven patients managed with Impella 5.0, one patients used Impella CP and four patients used peripheral veno-arterial extracorporeal membrane oxygenation (VA-ECMO) before Impella 5.0 implantation. On the other hand, of 19 patients managed with eLVAD, 11 patients used VA-ECMO before eLVAD implantation. In patients managed with Impella 5.0, Impella 5.0 was removed successfully in two patients (29%) and four patients (71%) underwent the operation for durable LVAD. In patients managed with eLVAD, eLVAD was successfully removed in three patients (16%), nine patients (47%) required durable LVAD, and seven patients (37%) died during eLVAD management. The period between implantation of Impella 5.0 or eLVAD to durable LVAD surgery was significantly shorter with Impella 5.0 (58 [38 - 95] vs. 235 [126 - 318] days, p=0.001). During durable LVAD implantation, cardiopulmonary bypass time was significantly shorter and a significantly smaller amount of red blood cells transfusion was required with Impella 5.0 (149 [125 - 182] vs. 192 [170 - 250] minutes, p=0.042; 7.0 [5.0 - 9.5] vs. 15.0 [10.0- 2.0] units, p=0.019, respectively). There were 4 massive stroke events in eLVAD, but no massive stroke events in Impella 5.0. In Impella 5.0. Conclusions: Impella 5.0 facilitates smoother management as a BTD and reduces surgical invasiveness during durable LVAD implantation. Impella 5.0 would be a more effective option for success to cardiac recovery or next therapy than eLVAD.

Left Ventricular Assist Device Implantation and Management

This chapter studies left ventricular assist device (LVAD) implantation. A thorough preoperative evaluation of a patient undergoing LVAD implantation is of utmost importance because of the confluence of associated medical problems patients can have secondary to heart failure. Knowledge of the indications and contraindications for LVAD implantation is needed to provide proper consultation. Indications for LVAD implantation include bridge to transplantation, destination therapy, bridge to decision, and bridge to recovery. Contraindications to LVAD implantation include neurological changes following implantation, pulmonary dysfunction, renal dysfunction, and hepatic dysfunction. Intraoperative management of LVAD implantation involves monitoring, anesthetic induction/maintenance, and device management. Echocardiography is an invaluable tool in the perioperative monitoring and diagnostic assessment of LVAD implantation. The chapter then looks at early complications such as hypovolemia, vasoplegia, and right ventricular failure.

Outcome of CentriMag™ extracorporeal mechanical circulatory support use in critical cardiogenic shock (INTERMACS 1) patients

Purpose Prognosis of patients presenting with INTERMACS 1 critical cardiogenic shock is generally poor. The aim of our study was to investigate the results of CentriMag™ extracorporeal short-term mechanical circulatory support as a bridge to decision in patients presenting with critical cardiogenic shock in our unit. Methods We retrospectively analysed 63 consecutive patients from January 2005 to June 2017, who were treated with a CentriMag™ device at our institution as a bridge to decision. Patients requiring extracorporeal support for post-cardiotomy shock and for primary graft dysfunction after heart transplantation were excluded. Results Patients’ median age was 44 years (IQR 31–52, range 15.4–62.0) and 42 (67%) were male. Primary diagnosis at presentation was ischaemic cardiomyopathy (n = 24; 38.1%), viral myocarditis (n = 19; 30.2%), idiopathic dilated cardiomyopathy (n = 8; 12.7%), and others (n = 12; 19%). The median duration of support was 25 (IQR 9.5–56) days. A total of 7 (11%) patients were supported with peripheral veno-arterial (VA) extra corporeal membrane oxygenation (ECMO), 6 (9%) with central VA ECMO, 8 (13%) with left ventricular assist device (LVAD), 17 (27%) with biventricular assist device (BiVAD), and 25 (40%) with ECMO and then converted to BiVAD. Overall, 22 (34.9%) patients died while on CentriMag™ mechanical circulatory support. Complications included bleeding requiring reoperation/intervention in 24 (38%), renal failure requiring dialysis in 29 (46%), bacterial infections in 23 (37%), fungal infections in 15 (24%), critical limb ischaemia in 6 (10%), and stroke in 8 (13%). The overall survival to successful explant from CentriMag™ was 65.1% (n = 41) and survival to hospital discharge was 58.7% (n = 37). Of these, 10 (16%) had cardiac recovery and were successfully explanted, 20 (32%) were bridged to heart transplantation, 11 (17%) were bridged to long-term left ventricular assist device, 3 (4.7%) were later on transplanted, and 1 (1.6%) recovered to decommissioning. The 1-, 5-, and 10-year survival rates were 55%, 46%, and 23% respectively. Conclusion Our results demonstrate an excellent outcome with the use of the CentriMag™ device in this seriously ill population. Despite requiring multiple procedures, over 58% of patients were discharged from hospital with 5-year survival of 46%.

Update on Weaning from Veno-Arterial Extracorporeal Membrane Oxygenation

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) provides temporary cardiac and respiratory support and has emerged as an established salvage intervention for patients with hemodynamic compromise or shock. It is thereby used as a bridge to recovery, bridge to permanent ventricular assist devices, bridge to transplantation, or bridge to decision. However, weaning from VA-ECMO differs between centers, and information about standardized weaning protocols are rare. Given the high mortality of patients undergoing VA-ECMO treatment, it is all the more important to answer the many questions still remaining unresolved in this field Standardized algorithms are recommended to optimize the weaning process and determine whether the VA-ECMO can be safely removed. Successful weaning as a multifactorial process requires sufficient recovery of myocardial and end-organ function. The patient should be considered hemodynamically stable, although left ventricular function often remains impaired during and after weaning. Echocardiographic and invasive hemodynamic monitoring seem to be indispensable when evaluating biventricular recovery and in determining whether the VA-ECMO can be weaned successfully or not, whereas cardiac biomarkers may not be useful in stratifying those who will recover. This review summarizes the strategies of weaning of VA-ECMO and discusses predictors of successful and poor weaning outcome.