OBJECTIVES The HeartWare HVAD (HW) and the HeartMate3 (HM3) are presently the most commonly used continuous-flow left ventricular assist devices worldwide. We compared the outcomes of patients supported with either of these 2 devices based on data from the EUROMACS (European Registry for Patients with Mechanical Circulatory Support). METHODS A retrospective analysis of the survival and complications profile in propensity score-matched adult patients enrolled in the EUROMACS between 01 January 2016 and 01 September 2020 and supported with either an HW or HM3. Matching included demographic parameters, severity of cardiogenic shock and risk-modifying end-organ parameters that impact long-term survival. Survival on device and major postoperative adverse events were analysed. RESULTS Following 1:1 propensity score matching, each group consisted of 361 patients. Patients were well balanced (<0.1 standardized mean difference). The median follow-up was similar in both groups [396 (interquartile range (IQR) 112–771) days for HW and 376 (IQR 100–816) days for HM3]. The 2-year survival was similar in both groups [HW: 61% 95% confidence interval (CI) (56–67%) vs HM3: 68% 95% CI (63–73%) (stratified hazard ratio for mortality: 1.13 95% CI (0.83–1.54), P = 0.435].The cumulative incidence for combined major adverse events and unexpected readmissions was similar in both groups [subdistribution hazard ratio (SHR) 1.0 (0.84–1.21), P = 0.96]. Patients in the HW group demonstrated a higher risk of device malfunction [SHR 2.44 (1.45–3.71), P < 0.001], neurological dysfunction [SHR 1.29 (1.02–1.61), P = 0.032] and intracranial bleeding [SHR 1.76 (1.13–2.70), P = 0.012]. CONCLUSIONS Mid-term survival in both groups was similar in a propensity-matched analysis. The risk of device malfunction, neurological dysfunction and intracranial bleeding was significantly higher in HW patients.
Background: Temporary mechanical circulatory support (MCS) offers a valuable option for treatment of refractory heart failure. We present our experience with selected MCS devices in cardiogenic shock of different etiologies. Methods: We retrospectively studied patients who were treated in our institution between 01/2016 and 07/2018. Patients receiving only veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support were excluded. Left ventricular support patients received Impella; right ventricular support was conducted using Levitronix CentriMag. Results: Thirty-seven patients received an Impella left ventricular assist device (LVAD). Etiology was: acute on chronic ischemic cardiomyopathy (ICMP; n=12), acute myocardial infarction (AMI; n=11), dilated cardiomyopathy (DCMP; n=7) and toxic cardiomyopathy (TCMP; n=2). Two patients presented with postcardiotomy shock and acute myocarditis, respectively. In one case, Takotsubo cardiomyopathy was diagnosed. Impella was used solely in 28 patients (Impella group) with an in-hospital survival of 37%. In nine patients, Impella was used in combination with extracorporeal life support (ECLS) implantation (ECMELLA group)-in-hospital survival was 33%. In the Impella group six patients recovered, six received a long-term VAD and 16 died on device. In the ECMELLA group one patient recovered, three received a long-term VAD and five died. The majority of CentriMag implantations as a right ventricular assist device (RVAD) were necessary after LVAD implantation (n=52); of these patients, 14 recovered, eight received long-term VAD and 30 died. The remaining 17 patients were supported by RVAD due to AMI (n=7); postcardiotomy (n=7); right heart failure after heart transplantation (n=2) and ICMP (n=1). Six of these patients recovered, two required long-term VAD and nine died. Conclusions: Survival after MCS implantation for left as well as right heart failure in cardiogenic shock remains low, but is superior to that of patients without mechanical support. Short-term MCS remains an option of choice if right, left or biventricular support is needed.
OBJECTIVES Short-term mechanical circulatory support is a life-saving treatment for acute cardiogenic shock (CS). This multicentre study investigates the preoperative predictors of 30-day mortality in CS patients treated with Impella 5.0 and 5.5 short-term left ventricular assist devices. METHODS Data of patients in CS (n = 70) treated with the Impella 5 (n = 63) and 5.5 (n = 7) in 2 centres in Berlin between October 2016 and October 2019 were collected retrospectively. RESULTS CS was caused by acute myocardial infarction (n = 16), decompensated chronic heart failure (n = 41), postcardiotomy syndrome (n = 5) and acute myocarditis (n = 8). Before implantation 12 (17%) patients underwent cardiopulmonary resuscitation and 32 (46%) patients were ventilated. INTERMACS level 1, 2 and 3 was established in 35 (50%), 29 (41%) and 6 (9%) of patients, respectively. The mean preoperative lactate level was 4.05 mmol/l. The median support time was 7 days (IR= 4–15). In 18 cases, the pump was removed for myocardial recovery, in 22 cases, durable left ventricular assist devices were implanted, and 30 patients died on support. The overall 30-day survival was 51%. Statistical analysis showed that an increase in lactate per mmol/l [odds ratio (OR) 1.217; P = 0.015] and cardiopulmonary resuscitation before implantation (OR 16.74; P = 0.009) are predictors of 30-day survival. Based on these data, an algorithm for optimal short-term mechanical circulatory support selection is proposed. CONCLUSIONS Impella treatment is feasible in severe CS. Severe organ dysfunction, as well as the level and duration of shock predict early mortality. An algorithm based on these parameters may help identify patients who would benefit from Impella 5+ support.
Background and methods Microaxial left ventricular assist devices are used increasingly for treating cardiogenic shock. We compared the short‐term outcome of patients supported with different microaxial devices for cardiogenic shock. A retrospective propensity score‐adjusted analysis was performed in cardiogenic shock patients treated with either the Impella CP (n = 64) or the Impella 5.0/5.5 (n = 62) at two tertiary cardiac care centers between 1/14 and 12/19. Results Patients in the Impella CP group were significantly older (69.6 ± 10.7 vs. 58.7 ± 11.9 years, p = .001), more likely in INTERMACS profile 1 (76.6% vs. 50%, p = .003) and post‐C‐reactive protein (CPR) (36% vs. 13%, p = .006). The median support time was 2.0 days [0.0, 5.3] in the CP group vs. 8.5 days [4.3, 15.8] in the 5.0/5.5 group (p < .001). The unadjusted 30‐day survival was significantly higher in the Impella 5.0/5.5 group (58% vs. 36%, p = .021, odds ratio [OR] for 30‐day survival on Impella 5.0/5.5 was 3.68 [95% confidence interval [CI]: [1.46–9.90]], p = .0072). After adjustment, the 30‐day survival was similar for both devices (OR: 1.23, 95% CI: [0.34–4.18], p = .744). Lactate levels above 8 mmol/L and preoperative CPR were associated with a significant mortality increase in both cohorts (OR: 10.7, 95% CI: [3.45–47.34], p < .001; OR: 13.2, 95% CI: [4.28–57.89], p < .001, respectively). Conclusion Both Impella devices offer a similar effect with regard to survival in cardiogenic shock patients. Preoperative CPR or lactate levels exceeding 8 mmol/L immediately before implantation have a poor prognosis on Impella CP and Impella 5.0/5.5.
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