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Retrospective 1-year outcome follow-up in 200 patients supported with HeartMate 3 and HeartWare left ventricular assist devices in a single centre

Retrospective 1-year outcome follow-up in 200 patients supported with HeartMate 3 and HeartWare... Abstract OBJECTIVES Various trials have assessed the outcome and reliability of the HeartWare HVAD (HW) and HeartMate 3 (HM3) left ventricular assist devices. A direct comparison of clinical outcomes and of the complication profile of these 2 left ventricular assist devices is lacking. We present a retrospective analysis of patients supported with HM3 and HW as a left ventricular assist device. METHODS Preoperative data, complications and outcomes including a 1-year follow-up of patients supported with the HM3 and HW in a single centre were retrospectively analysed. Both pumps were implanted on- or off-pump, employing standard and minimally invasive techniques. For logistic reasons, the 2 device types were implanted in an alternating manner, thereby reducing the systematic bias for pump selection. We considered this to be an appropriate approach, as no differences in respect of survival or the complication profile of the two device types have been demonstrated. Anticoagulation was similar in patients with both pumps according to our anticoagulation protocol, with a target international normalized ratio of 2.5–3.0, a home monitoring system and blood pressure management with a mean arterial target pressure of 70–80 mmHg. RESULTS Between October 2015 and April 2017, 100 patients underwent implantation of the HW and 100 patients underwent implantation of the HM3. The median time on the device was 0.98 years (range 0–2.23 years). The median age was 58.5 (51–65) versus 57 (49–64) years (P = 0.456); the number of male patients was 87 versus 88 (P = 0.831). Of the HW patients, 73% were rated as having an INTERMACS level I or II, compared to 57% of the HM3 patients (P = 0.018). There were no further differences in preoperative data. A total of 14 patients had pre-, intra- or post-pump blood flow obstruction in the HW group versus 4 in the HM3 group [hazard ratio (HR) 2.5 (0.7–8.8), P = 0.103]. There were no differences regarding gastrointestinal bleeding [HR 1.25 (0.56–2.64), P = 0.624] or driveline infection (0.68 vs 0.8 events per patient-year, P = 0.0789). The incidence of ischaemic stroke was similar in both groups [HR 0.72 (0.25–2.09), P = 0.550]. Cerebral bleeding was more frequent in patients supported with HW [HR 6.79 (1.43–32.20), P = 0.016]. The incidence of cerebrovascular accidents, on the other hand, was similar in both groups [HR 1.85 (0.83–4.19), P = 0.13]. The incidence of haemocompatibility-related adverse events, however, was significantly higher in the HW group (113 points corresponding to 1.28 events per patient-year versus 69 points corresponding to 0.7 events per patient-year, P < 0.001). The 1-year survival was similar in both groups [62.2%, 95% confidence interval (CI) (0.53–0.73) vs 66.7%, 95% CI (0.58–767), P = 0.372]. CONCLUSIONS Our data show that the complication profile differs between the 2 pumps, but that early survival is comparable. Comparison of left ventricular assist devices, Complication profile, Survival INTRODUCTION Long-term left ventricular assist devices (LVAD) are part of the standard care in patients with end-stage heart failure [1, 2]. Among the commercially available continuous-flow LVADs, 2 devices are most commonly used worldwide. The HeartWare HVAD (HW; Medtronic, Minneapolis, MN, USA) has been implanted in >16 000 patients and the HeartMate 3 (HM3; Abbott, Chicago, IL, USA) in >5500 patients. Both pumps bear the CE mark and are FDA-approved. Two prospective comparative studies have been published; however, in both studies, the older pump, the HeartMate II with mechanical bearings, was used for the comparison [3, 4]. A direct comparison between the HW and the HM3 is lacking. Both pumps are routinely implanted at the German Heart Center Berlin because no direct comparison and no advantages of one pump over the other have been reported thus far. Patients supported with either of the pumps undergo evaluation, implantation, and treatment by the same team of surgeons, cardiologists and VAD coordinators. The pumps differ in terms of size, principle of levitation, speed, lavage cycle and gap size between the impeller and the housing. How these differences impact the outcome in real-world settings is unclear. We retrospectively analysed our experience with the HW and the HM3 as LVADs and compared complications and outcomes in adult patients who underwent implantation with one of these 2 pumps at our institution, with the aim of allocating the most suitable pump to each individual patient. METHODS The study was designed as a single-centre observational, retrospective analysis. The complications (neurological, inflectional, gastrointestinal and thrombotic) were defined and followed up according to the INTERMACS definitions used in the recently published Momentum trial [4, 5]. All patients aged >17 years were included in the analysis. The study was approved by the local ethics committee (EA2/182/18). Haemocompatibility-related adverse events including gastrointestinal bleeding, stroke and thrombosis were recorded and scores compared between groups as event per patient-year [6]. All data routinely stored in our clinical database were analysed. Preoperative data, including demographic and echocardiographic data, as well as haemodynamic and laboratory data, collected prior to the LVAD implantation were included. Postoperative data including complications and outcomes that occurred within the minimum 1-year follow-up were analysed. Patients with primary biventricular VADs were excluded from our study. Surgery Both pumps were implanted by 2 surgeons (E.P. and T.K.) employing median sternotomy, bilateral minimally invasive access with connection of the graft to the ascending aorta [7]. In patients with a history of cardiac surgery and without the need for a concomitant procedure, left lateral thoracotomy with connection of the graft to the descending aorta was performed. All 3 approaches utilized on- or off-pump techniques. The surgical approach and employment of on/off-pump techniques were selected according to the clinical situation as judged by the surgeon based on his experience and the patient’s clinical status. For logistic reasons (delivery and availability of devices at the hospital), the 2 devices were implanted in an alternating manner. Postoperative treatment Anticoagulation was administered according to our institutional protocol and was identical for both pumps. Briefly, heparin was started 6 h after surgery if no significant bleeding occurred. After removal of the chest tubes and after switching the patient to oral medication, a vitamin K antagonist was administered with a target international normalized ratio of 2.5–3.0. In addition, acetylsalicylic acid 50–150 mg was given with a target suppression of 30% for the arachidonic acid channel. In most cases, the acetylsalicylic acid dose ranged between 50 and 100 mg. In patients with type II heparin-induced thrombocytopaenia, bridging to the vitamin K antagonist was performed with argatroban (Argatra, Mitsubishi Tanabe Pharma, Osaka, Japan) with an activated partial thromboplastin time of 60–70 s. The mean blood pressure target was 70–80 mmHg in both groups. Opening of the aortic valve with at least every third heartbeat was preferred but was not a mandatory goal of the pump speed regulation. In every patient receiving the HW, we used the Lavare Cycle. Statistical analysis The STROBE checklist was used for reporting observational studies [8]. Categorical data are summarized as frequencies and percentages, and continuous variables are summarized as mean and standard deviation or, in the case of skewed data, as median and interquartile range. Differences between the LVAD types were analysed using the χ2 test, t-test or Mann–Whitney U-test as appropriate. Survival was evaluated by Kaplan–Meier estimates censoring for transplantation, weaning and ongoing support. Differences between the HW and HM3 groups were assessed by log-rank testing. Competing risks models were used to evaluate the incidence of complications, with death, transplantation and weaning as competing outcomes. Subdistributional hazard ratios (HRs) were calculated using Fine and Grey models adjusting for age, gender, INTERMACS level and preoperative use of extracorporeal life support (ECLS). We assumed a P-value of <0.05 as the threshold for statistical significance. Analyses were exploratory in nature. For all statistical analysis, we used R software, version 3.5.0. RESULTS Between October 2015 and April 2017, 100 patients underwent implantation of an HW and 100 patients underwent implantation of an HM3. The median time on the device was 0.98 years (range 0–2.23 years). The median age was 58.5 (interquartile range 51–65) vs 57 (interquartile range 49–64) years (P = 0.456); the number of male patients was 87 vs 88 (P = 0.831). The preoperative characteristics and surgical techniques in the 2 groups are shown in Table 1. There was no difference in the surgical techniques. More HW patients were classified as having INTERMACS level I or II (73 vs 57%, P = 0.018). In the HW group, 33 patients were bridged to LVAD by temporary mechanical circulatory support (Impella, ECLS alone or in combination with Impella or an intra-aortic balloon pump) compared to 23 patients in the HM3 group (P = 0.115). Table 1: Preoperative characteristics of and surgical techniques in patients supported with HeartWare HVAD and HeartMate 3 . HeartWare (n = 100) . HeartMate 3 (n = 100) . P-value . Age (years) 58.5 (51.0–65.0) 57.0 (49.0–64.0) 0.456 Male gender 87 88 0.831 Bridge-to-transplant strategy 48 46 0.811 Mean weight (kg) 83.47 (18.44) 83.66 (19.16) 0.943 Mean BSA (m²) 2.01 (0.24) 2.01 (0.25) 0.968 Mean LVEF (%) 16.79 (5.41) 16.55 (5.81) 0.762 Median creatinine 1.40 (1.10–2.20) 1.30 (1.00–1.80) 0.109 Median haematocrit (%) 31.60 (28.30–34.90) 33.00 (28.55–39.05) 0.037 Median serum albumin (g/dl) 2.70 (1.90–3.15) 2.60 (2.00–3.15) 0.978 Median platelet count (T/mcl) 170.00 (112.00–217.00) 165.00 (111.50–232.50) 0.772 INTERMACS I + II 73 57 0.018 Prior cardiac surgery 32 32 0.961 Sternotomy 81 84 0.710 LLT with anastomosis to descending aorta 17 13 0.553 Minimal invasive (bilateral thoracotomy) 2 3 1 Off-pump 13 6 0.148 . HeartWare (n = 100) . HeartMate 3 (n = 100) . P-value . Age (years) 58.5 (51.0–65.0) 57.0 (49.0–64.0) 0.456 Male gender 87 88 0.831 Bridge-to-transplant strategy 48 46 0.811 Mean weight (kg) 83.47 (18.44) 83.66 (19.16) 0.943 Mean BSA (m²) 2.01 (0.24) 2.01 (0.25) 0.968 Mean LVEF (%) 16.79 (5.41) 16.55 (5.81) 0.762 Median creatinine 1.40 (1.10–2.20) 1.30 (1.00–1.80) 0.109 Median haematocrit (%) 31.60 (28.30–34.90) 33.00 (28.55–39.05) 0.037 Median serum albumin (g/dl) 2.70 (1.90–3.15) 2.60 (2.00–3.15) 0.978 Median platelet count (T/mcl) 170.00 (112.00–217.00) 165.00 (111.50–232.50) 0.772 INTERMACS I + II 73 57 0.018 Prior cardiac surgery 32 32 0.961 Sternotomy 81 84 0.710 LLT with anastomosis to descending aorta 17 13 0.553 Minimal invasive (bilateral thoracotomy) 2 3 1 Off-pump 13 6 0.148 For mean values the standard deviation and for median values the interquartile ranges are shown. BSA: body surface area, calculated according to Mosteller; LLT: left lateral thoracotomy; LVEF: left ventricular ejection fraction, calculated by echocardiography. Open in new tab Table 1: Preoperative characteristics of and surgical techniques in patients supported with HeartWare HVAD and HeartMate 3 . HeartWare (n = 100) . HeartMate 3 (n = 100) . P-value . Age (years) 58.5 (51.0–65.0) 57.0 (49.0–64.0) 0.456 Male gender 87 88 0.831 Bridge-to-transplant strategy 48 46 0.811 Mean weight (kg) 83.47 (18.44) 83.66 (19.16) 0.943 Mean BSA (m²) 2.01 (0.24) 2.01 (0.25) 0.968 Mean LVEF (%) 16.79 (5.41) 16.55 (5.81) 0.762 Median creatinine 1.40 (1.10–2.20) 1.30 (1.00–1.80) 0.109 Median haematocrit (%) 31.60 (28.30–34.90) 33.00 (28.55–39.05) 0.037 Median serum albumin (g/dl) 2.70 (1.90–3.15) 2.60 (2.00–3.15) 0.978 Median platelet count (T/mcl) 170.00 (112.00–217.00) 165.00 (111.50–232.50) 0.772 INTERMACS I + II 73 57 0.018 Prior cardiac surgery 32 32 0.961 Sternotomy 81 84 0.710 LLT with anastomosis to descending aorta 17 13 0.553 Minimal invasive (bilateral thoracotomy) 2 3 1 Off-pump 13 6 0.148 . HeartWare (n = 100) . HeartMate 3 (n = 100) . P-value . Age (years) 58.5 (51.0–65.0) 57.0 (49.0–64.0) 0.456 Male gender 87 88 0.831 Bridge-to-transplant strategy 48 46 0.811 Mean weight (kg) 83.47 (18.44) 83.66 (19.16) 0.943 Mean BSA (m²) 2.01 (0.24) 2.01 (0.25) 0.968 Mean LVEF (%) 16.79 (5.41) 16.55 (5.81) 0.762 Median creatinine 1.40 (1.10–2.20) 1.30 (1.00–1.80) 0.109 Median haematocrit (%) 31.60 (28.30–34.90) 33.00 (28.55–39.05) 0.037 Median serum albumin (g/dl) 2.70 (1.90–3.15) 2.60 (2.00–3.15) 0.978 Median platelet count (T/mcl) 170.00 (112.00–217.00) 165.00 (111.50–232.50) 0.772 INTERMACS I + II 73 57 0.018 Prior cardiac surgery 32 32 0.961 Sternotomy 81 84 0.710 LLT with anastomosis to descending aorta 17 13 0.553 Minimal invasive (bilateral thoracotomy) 2 3 1 Off-pump 13 6 0.148 For mean values the standard deviation and for median values the interquartile ranges are shown. BSA: body surface area, calculated according to Mosteller; LLT: left lateral thoracotomy; LVEF: left ventricular ejection fraction, calculated by echocardiography. Open in new tab The complication profiles of the 2 groups differ in terms of device-related complications. Pre-pump thrombosis was reported in 5 patients with HW and in 1 patient in the HM3 population. In the event of an inflow thrombus, the washout manoeuvre was performed [9]. The treatment in the HW population was successful. In 1 patient on the HM3, treatment was unsuccessful and the HM3 had to be replaced [10]. The incidence of intra-pump thrombosis was higher in the HW group (7 vs 0 events); any occurrence of intra-pump thrombosis in HW patients was successfully treated by lysis with recombinant tissue-type plasminogen activator in 4 patients. One of these 4 patients developed intracranial bleeding. In 3 patients, pump replacement became necessary after pump thrombosis occurred shortly after the implantation (after 2, 3 and 6 days, respectively). Three patients supported with the HM3 presented 4 cases of outflow graft twist, which did not occur in any of the HW patients (i.e. 4 vs 0 events). In HW patients, stenosis of the outflow graft anastomosis with the aorta was treated by interventional stenting in 2 cases. This complication was not reported in HM3 patients. The probability of blood flow obstruction through the pump requiring lysis, stenting or surgical revision is presented in Fig. 1. Selected pump-related complications are presented in Table 2. In the case of multiple events, only 1 is counted in the table. Figure 1: Open in new tabDownload slide Cumulative incidence function for blood flow obstruction requiring lysis, catheter-based or surgical intervention in both groups. HM3: HeartMate 3; HW: HeartWare HVAD; not on support: death, transplant or weaning. Figure 1: Open in new tabDownload slide Cumulative incidence function for blood flow obstruction requiring lysis, catheter-based or surgical intervention in both groups. HM3: HeartMate 3; HW: HeartWare HVAD; not on support: death, transplant or weaning. Table 2: Cumulative incidences rates at 1 year and SHR with CIs with adjusted P-value for important clinical complications Events . HW . HM3 . SHR . 95% (CI) . P-value . Ischaemic stroke 6 8 0.72 0.25–2.09 0.550 Intracranial bleeding 8 2 6.79 1.43–32.20 0.016 Cerebrovascular accidents 14 10 1.85 0.83–4.19 0.134 Blood flow obstruction requiring lysis, catheter-based or surgical intervention in both groups 9 2 2.57 0.75–8.75 0.130 Events . HW . HM3 . SHR . 95% (CI) . P-value . Ischaemic stroke 6 8 0.72 0.25–2.09 0.550 Intracranial bleeding 8 2 6.79 1.43–32.20 0.016 Cerebrovascular accidents 14 10 1.85 0.83–4.19 0.134 Blood flow obstruction requiring lysis, catheter-based or surgical intervention in both groups 9 2 2.57 0.75–8.75 0.130 In case of an ischaemic event and secondary intracranial bleeding, only 1 event was taken into consideration. CI: confidence interval; HM3: HeartMate 3; HW: HeartWare HVAD; SHR: subdistribution hazard ratios. Open in new tab Table 2: Cumulative incidences rates at 1 year and SHR with CIs with adjusted P-value for important clinical complications Events . HW . HM3 . SHR . 95% (CI) . P-value . Ischaemic stroke 6 8 0.72 0.25–2.09 0.550 Intracranial bleeding 8 2 6.79 1.43–32.20 0.016 Cerebrovascular accidents 14 10 1.85 0.83–4.19 0.134 Blood flow obstruction requiring lysis, catheter-based or surgical intervention in both groups 9 2 2.57 0.75–8.75 0.130 Events . HW . HM3 . SHR . 95% (CI) . P-value . Ischaemic stroke 6 8 0.72 0.25–2.09 0.550 Intracranial bleeding 8 2 6.79 1.43–32.20 0.016 Cerebrovascular accidents 14 10 1.85 0.83–4.19 0.134 Blood flow obstruction requiring lysis, catheter-based or surgical intervention in both groups 9 2 2.57 0.75–8.75 0.130 In case of an ischaemic event and secondary intracranial bleeding, only 1 event was taken into consideration. CI: confidence interval; HM3: HeartMate 3; HW: HeartWare HVAD; SHR: subdistribution hazard ratios. Open in new tab The incidence of ischaemic stroke was similar in both groups [adjusted HR 0.64 (0.23–1.79), P = 0.359; Fig. 2]. Cerebral bleeding was more frequent in patients supported with the HW [adjusted HR 6.79 (1.43–32.20), P = 0.016; Fig. 3]. The incidence of cerebrovascular accidents, on the other hand, did not differ significantly between the 2 groups [adjusted HR 1.85 (0.83–4.19), P = 0.13; Fig. 4]. Cerebrovascular accident is a composite of neurological events and includes stroke, transient ischaemic attack and intracranial bleeding. In the HW group, 6 patients died due to cerebrovascular accidents, in all cases cerebral bleeding. In the HM3 group, 3 patients died due to neurological events. One patient developed intracranial bleeding, and 2 patients died of a stroke. Patients with transient ischaemic attack were also enrolled. One patient, also with cerebral bleeding following recombinant tissue-type plasminogen activator lysis for pump thrombosis, was excluded from the analysis. Figure 2: Open in new tabDownload slide Cumulative incidence function of ischaemic stroke in both groups. HM3: HeartMate 3; HW: HeartWare HVAD; not on support: death, transplant or weaning. Figure 2: Open in new tabDownload slide Cumulative incidence function of ischaemic stroke in both groups. HM3: HeartMate 3; HW: HeartWare HVAD; not on support: death, transplant or weaning. Figure 3: Open in new tabDownload slide Cumulative incidence function of cerebral bleeding in both groups. HM3: HeartMate 3; HW: HeartWare HVAD; not on support: death, transplant or weaning. Figure 3: Open in new tabDownload slide Cumulative incidence function of cerebral bleeding in both groups. HM3: HeartMate 3; HW: HeartWare HVAD; not on support: death, transplant or weaning. Figure 4: Open in new tabDownload slide Cumulative incidence function for cerebrovascular accidents in both groups. HM3: HeartMate 3; HW: HeartWare HVAD; not on support: death, transplant or weaning. Figure 4: Open in new tabDownload slide Cumulative incidence function for cerebrovascular accidents in both groups. HM3: HeartMate 3; HW: HeartWare HVAD; not on support: death, transplant or weaning. Figure 5 shows the measurements in the outpatient department for international normalized ratio (a), mean arterial pressure (b) and lactate dehydrogenase (c), stratified by groups. No differences were noted between the groups during the follow-up period. The incidence of haemocompatibility-related adverse events was significantly higher in the HW group (113 points corresponding to 1.28 events per patient-year versus 69 points corresponding to 0.7 events per patient-year, P < 0.001). The incidence of gastrointestinal bleeding was similar in both groups [HR 1.25 (0.56–2.64), P = 0.624]. Figure 5: Open in new tabDownload slide Outpatient measurements of international normalized ratio, mean arterial pressure and lactate dehydrogenase. HM3: HeartMate 3; HW: HeartWare HVAD. Figure 5: Open in new tabDownload slide Outpatient measurements of international normalized ratio, mean arterial pressure and lactate dehydrogenase. HM3: HeartMate 3; HW: HeartWare HVAD. There was a trend towards more driveline infections in HM3 patients (0.68 vs 0.8 events per patient-year, P = 0.0704). The 1-year survival was similar in both groups [62.2%, 95% confidence interval (CI) (0.53–0.73) vs 66.7%, 95% CI (0.58–767), P = 0.372]. The Kaplan–Meier analysis regarding survival is shown in Fig. 6. The HRs, CIs and P-values are presented in Table 2. Figure 6: Open in new tabDownload slide Kaplan–Meier analysis of survival in both groups. HM3: HeartMate 3; HW: HeartWare HVAD. Figure 6: Open in new tabDownload slide Kaplan–Meier analysis of survival in both groups. HM3: HeartMate 3; HW: HeartWare HVAD. Open in new tabDownload slide Open in new tabDownload slide DISCUSSION The present retrospective single-centre observational study demonstrated similar survival in the first year after implantation of the HW and HM3. Furthermore, the incidence of all pump-related complications requiring surgical intervention was similar in both groups. One important observation is that the 2 analysed pumps have different complication profiles. While the HW was associated with a higher incidence of pump thrombosis requiring lysis or pump exchange, the HM3 more often exhibited a twist of the outflow graft requiring surgical revision. Furthermore, patients supported with the HW presented with more intracranial bleeding episodes, while the probability of ischaemic stroke was similar in both groups. For logistic reasons, the 2 device types were used alternatingly to reduce a systematic bias in the pump selection. However, there were differences in the preoperative status between the groups—more HW patients were in cardiogenic shock as reflected by a significantly lower INTERMACS status. The reason may be the surgeon’s choice to implant HW in high-risk cases (e.g. being on temporary ECLS, cachexia and congenital heart disease) because of its smaller size, thus facilitating implantation in complex cases, and the greater experience with this device at our institution. We have been implanting HW since September 2009 and participated in the CE-mark trial for the HM. We have been using this durable device since it became commercially available in Germany. The longer experience may indicate a preferential use of HVAD in high-risk cases because of its smaller size and its simple, fast implantation compared with HeartMate3. The significantly lower INTERMACS level in the HW group reflects this bias in part. More haemocompatibility-related adverse events in the HW group may be due to the lower INTERMACS status. However, it remains unclear to us how this constellation may lead to a higher incidence of haemorrhagic stroke in HW patients, since the difference was detected after 1 year on support. The results obtained in our retrospective analysis of the complication profiles are in line with the published results of the prospective Momentum trial. In this trial, no differences in survival or in the incidence of disabling stroke were found between the HM3 and the HM II. In the HM3 CE mark study, the survival after 12 months was 81% [11], and in the Momentum 3 trial, the 1-year survival was 86.6% [4]. However, a direct comparison of our data with those from the Momentum 3 and Endurance trials is not expedient since, in Momentum 3, data from patients with an INTERMACS level I amounted to <5%, while in our study, patients of all levels were included and, therefore, 37% and 26% of patients were classified as having INTERMACS level I, mostly on ECLS or Impella support. Finally, based on the present study, we were unable to identify any properties that would allow a selection of the pump tailored to the individual patient. Only 1 feature—the smaller size of the HW—offers a definite advantage in patients with a smaller stature and allows implantation in children weighing <20 kg [12], even in a biventricular fashion [13]. In our opinion, only a prospective, multicentre, randomized study can ultimately gather evidence about differences in the performance of the 2 pumps and allow pump selection to be based on the clinical situation of each individual patient. Limitations This is a single-centre, retrospective analysis with a 1-year follow-up. In our centre, the percentage of patients in INTERMACS I and II is much higher than in the Endurance and Momentum 3 trials. This may be a reason for the lower survival in our patients and may cause differences in the complications between the 2 pumps. Further studies are needed. CONCLUSION In our centre, and based on the current observational study, patients supported with the HW and HM3 pumps showed a different complication profile, but similar intermediate-term survival. A prospective, randomized, multicentre study is required to confirm these results. Conflict of interest: Evgenij Potapov: Proctoring for Abbott and Medtronic; Christoph Starck: Adviser for Medtronic and Abbott; Volkmar Falk: Adviser for Medtronic and Abbott; Johanna Mulzer: Adviser for Medtronic; Marcus Mueller: Adviser for Medtronic; all: institutional travel grants. Author contributions Marcus Mueller: Conceptualization; Data curation; Investigation; Writing—original draft. Christoph Hoermandinger: Data curation; Investigation. Gregor Richter: Data curation; Investigation. Johanna Mulzer: Data curation. Dmytro Tsyganenko: Data curation. Thomas Krabatsch: Supervision. Christoph Starck: Data curation. Julia Stein: Validation. Felix Schoenrath: Data curation. Volkmar Falk: Supervision. Evgenij Potapov: Conceptualization. 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Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png European Journal of Cardio-Thoracic Surgery Oxford University Press

Retrospective 1-year outcome follow-up in 200 patients supported with HeartMate 3 and HeartWare left ventricular assist devices in a single centre

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Oxford University Press
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© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
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1010-7940
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1873-734X
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10.1093/ejcts/ezaa017
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Abstract OBJECTIVES Various trials have assessed the outcome and reliability of the HeartWare HVAD (HW) and HeartMate 3 (HM3) left ventricular assist devices. A direct comparison of clinical outcomes and of the complication profile of these 2 left ventricular assist devices is lacking. We present a retrospective analysis of patients supported with HM3 and HW as a left ventricular assist device. METHODS Preoperative data, complications and outcomes including a 1-year follow-up of patients supported with the HM3 and HW in a single centre were retrospectively analysed. Both pumps were implanted on- or off-pump, employing standard and minimally invasive techniques. For logistic reasons, the 2 device types were implanted in an alternating manner, thereby reducing the systematic bias for pump selection. We considered this to be an appropriate approach, as no differences in respect of survival or the complication profile of the two device types have been demonstrated. Anticoagulation was similar in patients with both pumps according to our anticoagulation protocol, with a target international normalized ratio of 2.5–3.0, a home monitoring system and blood pressure management with a mean arterial target pressure of 70–80 mmHg. RESULTS Between October 2015 and April 2017, 100 patients underwent implantation of the HW and 100 patients underwent implantation of the HM3. The median time on the device was 0.98 years (range 0–2.23 years). The median age was 58.5 (51–65) versus 57 (49–64) years (P = 0.456); the number of male patients was 87 versus 88 (P = 0.831). Of the HW patients, 73% were rated as having an INTERMACS level I or II, compared to 57% of the HM3 patients (P = 0.018). There were no further differences in preoperative data. A total of 14 patients had pre-, intra- or post-pump blood flow obstruction in the HW group versus 4 in the HM3 group [hazard ratio (HR) 2.5 (0.7–8.8), P = 0.103]. There were no differences regarding gastrointestinal bleeding [HR 1.25 (0.56–2.64), P = 0.624] or driveline infection (0.68 vs 0.8 events per patient-year, P = 0.0789). The incidence of ischaemic stroke was similar in both groups [HR 0.72 (0.25–2.09), P = 0.550]. Cerebral bleeding was more frequent in patients supported with HW [HR 6.79 (1.43–32.20), P = 0.016]. The incidence of cerebrovascular accidents, on the other hand, was similar in both groups [HR 1.85 (0.83–4.19), P = 0.13]. The incidence of haemocompatibility-related adverse events, however, was significantly higher in the HW group (113 points corresponding to 1.28 events per patient-year versus 69 points corresponding to 0.7 events per patient-year, P < 0.001). The 1-year survival was similar in both groups [62.2%, 95% confidence interval (CI) (0.53–0.73) vs 66.7%, 95% CI (0.58–767), P = 0.372]. CONCLUSIONS Our data show that the complication profile differs between the 2 pumps, but that early survival is comparable. Comparison of left ventricular assist devices, Complication profile, Survival INTRODUCTION Long-term left ventricular assist devices (LVAD) are part of the standard care in patients with end-stage heart failure [1, 2]. Among the commercially available continuous-flow LVADs, 2 devices are most commonly used worldwide. The HeartWare HVAD (HW; Medtronic, Minneapolis, MN, USA) has been implanted in >16 000 patients and the HeartMate 3 (HM3; Abbott, Chicago, IL, USA) in >5500 patients. Both pumps bear the CE mark and are FDA-approved. Two prospective comparative studies have been published; however, in both studies, the older pump, the HeartMate II with mechanical bearings, was used for the comparison [3, 4]. A direct comparison between the HW and the HM3 is lacking. Both pumps are routinely implanted at the German Heart Center Berlin because no direct comparison and no advantages of one pump over the other have been reported thus far. Patients supported with either of the pumps undergo evaluation, implantation, and treatment by the same team of surgeons, cardiologists and VAD coordinators. The pumps differ in terms of size, principle of levitation, speed, lavage cycle and gap size between the impeller and the housing. How these differences impact the outcome in real-world settings is unclear. We retrospectively analysed our experience with the HW and the HM3 as LVADs and compared complications and outcomes in adult patients who underwent implantation with one of these 2 pumps at our institution, with the aim of allocating the most suitable pump to each individual patient. METHODS The study was designed as a single-centre observational, retrospective analysis. The complications (neurological, inflectional, gastrointestinal and thrombotic) were defined and followed up according to the INTERMACS definitions used in the recently published Momentum trial [4, 5]. All patients aged >17 years were included in the analysis. The study was approved by the local ethics committee (EA2/182/18). Haemocompatibility-related adverse events including gastrointestinal bleeding, stroke and thrombosis were recorded and scores compared between groups as event per patient-year [6]. All data routinely stored in our clinical database were analysed. Preoperative data, including demographic and echocardiographic data, as well as haemodynamic and laboratory data, collected prior to the LVAD implantation were included. Postoperative data including complications and outcomes that occurred within the minimum 1-year follow-up were analysed. Patients with primary biventricular VADs were excluded from our study. Surgery Both pumps were implanted by 2 surgeons (E.P. and T.K.) employing median sternotomy, bilateral minimally invasive access with connection of the graft to the ascending aorta [7]. In patients with a history of cardiac surgery and without the need for a concomitant procedure, left lateral thoracotomy with connection of the graft to the descending aorta was performed. All 3 approaches utilized on- or off-pump techniques. The surgical approach and employment of on/off-pump techniques were selected according to the clinical situation as judged by the surgeon based on his experience and the patient’s clinical status. For logistic reasons (delivery and availability of devices at the hospital), the 2 devices were implanted in an alternating manner. Postoperative treatment Anticoagulation was administered according to our institutional protocol and was identical for both pumps. Briefly, heparin was started 6 h after surgery if no significant bleeding occurred. After removal of the chest tubes and after switching the patient to oral medication, a vitamin K antagonist was administered with a target international normalized ratio of 2.5–3.0. In addition, acetylsalicylic acid 50–150 mg was given with a target suppression of 30% for the arachidonic acid channel. In most cases, the acetylsalicylic acid dose ranged between 50 and 100 mg. In patients with type II heparin-induced thrombocytopaenia, bridging to the vitamin K antagonist was performed with argatroban (Argatra, Mitsubishi Tanabe Pharma, Osaka, Japan) with an activated partial thromboplastin time of 60–70 s. The mean blood pressure target was 70–80 mmHg in both groups. Opening of the aortic valve with at least every third heartbeat was preferred but was not a mandatory goal of the pump speed regulation. In every patient receiving the HW, we used the Lavare Cycle. Statistical analysis The STROBE checklist was used for reporting observational studies [8]. Categorical data are summarized as frequencies and percentages, and continuous variables are summarized as mean and standard deviation or, in the case of skewed data, as median and interquartile range. Differences between the LVAD types were analysed using the χ2 test, t-test or Mann–Whitney U-test as appropriate. Survival was evaluated by Kaplan–Meier estimates censoring for transplantation, weaning and ongoing support. Differences between the HW and HM3 groups were assessed by log-rank testing. Competing risks models were used to evaluate the incidence of complications, with death, transplantation and weaning as competing outcomes. Subdistributional hazard ratios (HRs) were calculated using Fine and Grey models adjusting for age, gender, INTERMACS level and preoperative use of extracorporeal life support (ECLS). We assumed a P-value of <0.05 as the threshold for statistical significance. Analyses were exploratory in nature. For all statistical analysis, we used R software, version 3.5.0. RESULTS Between October 2015 and April 2017, 100 patients underwent implantation of an HW and 100 patients underwent implantation of an HM3. The median time on the device was 0.98 years (range 0–2.23 years). The median age was 58.5 (interquartile range 51–65) vs 57 (interquartile range 49–64) years (P = 0.456); the number of male patients was 87 vs 88 (P = 0.831). The preoperative characteristics and surgical techniques in the 2 groups are shown in Table 1. There was no difference in the surgical techniques. More HW patients were classified as having INTERMACS level I or II (73 vs 57%, P = 0.018). In the HW group, 33 patients were bridged to LVAD by temporary mechanical circulatory support (Impella, ECLS alone or in combination with Impella or an intra-aortic balloon pump) compared to 23 patients in the HM3 group (P = 0.115). Table 1: Preoperative characteristics of and surgical techniques in patients supported with HeartWare HVAD and HeartMate 3 . HeartWare (n = 100) . HeartMate 3 (n = 100) . P-value . Age (years) 58.5 (51.0–65.0) 57.0 (49.0–64.0) 0.456 Male gender 87 88 0.831 Bridge-to-transplant strategy 48 46 0.811 Mean weight (kg) 83.47 (18.44) 83.66 (19.16) 0.943 Mean BSA (m²) 2.01 (0.24) 2.01 (0.25) 0.968 Mean LVEF (%) 16.79 (5.41) 16.55 (5.81) 0.762 Median creatinine 1.40 (1.10–2.20) 1.30 (1.00–1.80) 0.109 Median haematocrit (%) 31.60 (28.30–34.90) 33.00 (28.55–39.05) 0.037 Median serum albumin (g/dl) 2.70 (1.90–3.15) 2.60 (2.00–3.15) 0.978 Median platelet count (T/mcl) 170.00 (112.00–217.00) 165.00 (111.50–232.50) 0.772 INTERMACS I + II 73 57 0.018 Prior cardiac surgery 32 32 0.961 Sternotomy 81 84 0.710 LLT with anastomosis to descending aorta 17 13 0.553 Minimal invasive (bilateral thoracotomy) 2 3 1 Off-pump 13 6 0.148 . HeartWare (n = 100) . HeartMate 3 (n = 100) . P-value . Age (years) 58.5 (51.0–65.0) 57.0 (49.0–64.0) 0.456 Male gender 87 88 0.831 Bridge-to-transplant strategy 48 46 0.811 Mean weight (kg) 83.47 (18.44) 83.66 (19.16) 0.943 Mean BSA (m²) 2.01 (0.24) 2.01 (0.25) 0.968 Mean LVEF (%) 16.79 (5.41) 16.55 (5.81) 0.762 Median creatinine 1.40 (1.10–2.20) 1.30 (1.00–1.80) 0.109 Median haematocrit (%) 31.60 (28.30–34.90) 33.00 (28.55–39.05) 0.037 Median serum albumin (g/dl) 2.70 (1.90–3.15) 2.60 (2.00–3.15) 0.978 Median platelet count (T/mcl) 170.00 (112.00–217.00) 165.00 (111.50–232.50) 0.772 INTERMACS I + II 73 57 0.018 Prior cardiac surgery 32 32 0.961 Sternotomy 81 84 0.710 LLT with anastomosis to descending aorta 17 13 0.553 Minimal invasive (bilateral thoracotomy) 2 3 1 Off-pump 13 6 0.148 For mean values the standard deviation and for median values the interquartile ranges are shown. BSA: body surface area, calculated according to Mosteller; LLT: left lateral thoracotomy; LVEF: left ventricular ejection fraction, calculated by echocardiography. Open in new tab Table 1: Preoperative characteristics of and surgical techniques in patients supported with HeartWare HVAD and HeartMate 3 . HeartWare (n = 100) . HeartMate 3 (n = 100) . P-value . Age (years) 58.5 (51.0–65.0) 57.0 (49.0–64.0) 0.456 Male gender 87 88 0.831 Bridge-to-transplant strategy 48 46 0.811 Mean weight (kg) 83.47 (18.44) 83.66 (19.16) 0.943 Mean BSA (m²) 2.01 (0.24) 2.01 (0.25) 0.968 Mean LVEF (%) 16.79 (5.41) 16.55 (5.81) 0.762 Median creatinine 1.40 (1.10–2.20) 1.30 (1.00–1.80) 0.109 Median haematocrit (%) 31.60 (28.30–34.90) 33.00 (28.55–39.05) 0.037 Median serum albumin (g/dl) 2.70 (1.90–3.15) 2.60 (2.00–3.15) 0.978 Median platelet count (T/mcl) 170.00 (112.00–217.00) 165.00 (111.50–232.50) 0.772 INTERMACS I + II 73 57 0.018 Prior cardiac surgery 32 32 0.961 Sternotomy 81 84 0.710 LLT with anastomosis to descending aorta 17 13 0.553 Minimal invasive (bilateral thoracotomy) 2 3 1 Off-pump 13 6 0.148 . HeartWare (n = 100) . HeartMate 3 (n = 100) . P-value . Age (years) 58.5 (51.0–65.0) 57.0 (49.0–64.0) 0.456 Male gender 87 88 0.831 Bridge-to-transplant strategy 48 46 0.811 Mean weight (kg) 83.47 (18.44) 83.66 (19.16) 0.943 Mean BSA (m²) 2.01 (0.24) 2.01 (0.25) 0.968 Mean LVEF (%) 16.79 (5.41) 16.55 (5.81) 0.762 Median creatinine 1.40 (1.10–2.20) 1.30 (1.00–1.80) 0.109 Median haematocrit (%) 31.60 (28.30–34.90) 33.00 (28.55–39.05) 0.037 Median serum albumin (g/dl) 2.70 (1.90–3.15) 2.60 (2.00–3.15) 0.978 Median platelet count (T/mcl) 170.00 (112.00–217.00) 165.00 (111.50–232.50) 0.772 INTERMACS I + II 73 57 0.018 Prior cardiac surgery 32 32 0.961 Sternotomy 81 84 0.710 LLT with anastomosis to descending aorta 17 13 0.553 Minimal invasive (bilateral thoracotomy) 2 3 1 Off-pump 13 6 0.148 For mean values the standard deviation and for median values the interquartile ranges are shown. BSA: body surface area, calculated according to Mosteller; LLT: left lateral thoracotomy; LVEF: left ventricular ejection fraction, calculated by echocardiography. Open in new tab The complication profiles of the 2 groups differ in terms of device-related complications. Pre-pump thrombosis was reported in 5 patients with HW and in 1 patient in the HM3 population. In the event of an inflow thrombus, the washout manoeuvre was performed [9]. The treatment in the HW population was successful. In 1 patient on the HM3, treatment was unsuccessful and the HM3 had to be replaced [10]. The incidence of intra-pump thrombosis was higher in the HW group (7 vs 0 events); any occurrence of intra-pump thrombosis in HW patients was successfully treated by lysis with recombinant tissue-type plasminogen activator in 4 patients. One of these 4 patients developed intracranial bleeding. In 3 patients, pump replacement became necessary after pump thrombosis occurred shortly after the implantation (after 2, 3 and 6 days, respectively). Three patients supported with the HM3 presented 4 cases of outflow graft twist, which did not occur in any of the HW patients (i.e. 4 vs 0 events). In HW patients, stenosis of the outflow graft anastomosis with the aorta was treated by interventional stenting in 2 cases. This complication was not reported in HM3 patients. The probability of blood flow obstruction through the pump requiring lysis, stenting or surgical revision is presented in Fig. 1. Selected pump-related complications are presented in Table 2. In the case of multiple events, only 1 is counted in the table. Figure 1: Open in new tabDownload slide Cumulative incidence function for blood flow obstruction requiring lysis, catheter-based or surgical intervention in both groups. HM3: HeartMate 3; HW: HeartWare HVAD; not on support: death, transplant or weaning. Figure 1: Open in new tabDownload slide Cumulative incidence function for blood flow obstruction requiring lysis, catheter-based or surgical intervention in both groups. HM3: HeartMate 3; HW: HeartWare HVAD; not on support: death, transplant or weaning. Table 2: Cumulative incidences rates at 1 year and SHR with CIs with adjusted P-value for important clinical complications Events . HW . HM3 . SHR . 95% (CI) . P-value . Ischaemic stroke 6 8 0.72 0.25–2.09 0.550 Intracranial bleeding 8 2 6.79 1.43–32.20 0.016 Cerebrovascular accidents 14 10 1.85 0.83–4.19 0.134 Blood flow obstruction requiring lysis, catheter-based or surgical intervention in both groups 9 2 2.57 0.75–8.75 0.130 Events . HW . HM3 . SHR . 95% (CI) . P-value . Ischaemic stroke 6 8 0.72 0.25–2.09 0.550 Intracranial bleeding 8 2 6.79 1.43–32.20 0.016 Cerebrovascular accidents 14 10 1.85 0.83–4.19 0.134 Blood flow obstruction requiring lysis, catheter-based or surgical intervention in both groups 9 2 2.57 0.75–8.75 0.130 In case of an ischaemic event and secondary intracranial bleeding, only 1 event was taken into consideration. CI: confidence interval; HM3: HeartMate 3; HW: HeartWare HVAD; SHR: subdistribution hazard ratios. Open in new tab Table 2: Cumulative incidences rates at 1 year and SHR with CIs with adjusted P-value for important clinical complications Events . HW . HM3 . SHR . 95% (CI) . P-value . Ischaemic stroke 6 8 0.72 0.25–2.09 0.550 Intracranial bleeding 8 2 6.79 1.43–32.20 0.016 Cerebrovascular accidents 14 10 1.85 0.83–4.19 0.134 Blood flow obstruction requiring lysis, catheter-based or surgical intervention in both groups 9 2 2.57 0.75–8.75 0.130 Events . HW . HM3 . SHR . 95% (CI) . P-value . Ischaemic stroke 6 8 0.72 0.25–2.09 0.550 Intracranial bleeding 8 2 6.79 1.43–32.20 0.016 Cerebrovascular accidents 14 10 1.85 0.83–4.19 0.134 Blood flow obstruction requiring lysis, catheter-based or surgical intervention in both groups 9 2 2.57 0.75–8.75 0.130 In case of an ischaemic event and secondary intracranial bleeding, only 1 event was taken into consideration. CI: confidence interval; HM3: HeartMate 3; HW: HeartWare HVAD; SHR: subdistribution hazard ratios. Open in new tab The incidence of ischaemic stroke was similar in both groups [adjusted HR 0.64 (0.23–1.79), P = 0.359; Fig. 2]. Cerebral bleeding was more frequent in patients supported with the HW [adjusted HR 6.79 (1.43–32.20), P = 0.016; Fig. 3]. The incidence of cerebrovascular accidents, on the other hand, did not differ significantly between the 2 groups [adjusted HR 1.85 (0.83–4.19), P = 0.13; Fig. 4]. Cerebrovascular accident is a composite of neurological events and includes stroke, transient ischaemic attack and intracranial bleeding. In the HW group, 6 patients died due to cerebrovascular accidents, in all cases cerebral bleeding. In the HM3 group, 3 patients died due to neurological events. One patient developed intracranial bleeding, and 2 patients died of a stroke. Patients with transient ischaemic attack were also enrolled. One patient, also with cerebral bleeding following recombinant tissue-type plasminogen activator lysis for pump thrombosis, was excluded from the analysis. Figure 2: Open in new tabDownload slide Cumulative incidence function of ischaemic stroke in both groups. HM3: HeartMate 3; HW: HeartWare HVAD; not on support: death, transplant or weaning. Figure 2: Open in new tabDownload slide Cumulative incidence function of ischaemic stroke in both groups. HM3: HeartMate 3; HW: HeartWare HVAD; not on support: death, transplant or weaning. Figure 3: Open in new tabDownload slide Cumulative incidence function of cerebral bleeding in both groups. HM3: HeartMate 3; HW: HeartWare HVAD; not on support: death, transplant or weaning. Figure 3: Open in new tabDownload slide Cumulative incidence function of cerebral bleeding in both groups. HM3: HeartMate 3; HW: HeartWare HVAD; not on support: death, transplant or weaning. Figure 4: Open in new tabDownload slide Cumulative incidence function for cerebrovascular accidents in both groups. HM3: HeartMate 3; HW: HeartWare HVAD; not on support: death, transplant or weaning. Figure 4: Open in new tabDownload slide Cumulative incidence function for cerebrovascular accidents in both groups. HM3: HeartMate 3; HW: HeartWare HVAD; not on support: death, transplant or weaning. Figure 5 shows the measurements in the outpatient department for international normalized ratio (a), mean arterial pressure (b) and lactate dehydrogenase (c), stratified by groups. No differences were noted between the groups during the follow-up period. The incidence of haemocompatibility-related adverse events was significantly higher in the HW group (113 points corresponding to 1.28 events per patient-year versus 69 points corresponding to 0.7 events per patient-year, P < 0.001). The incidence of gastrointestinal bleeding was similar in both groups [HR 1.25 (0.56–2.64), P = 0.624]. Figure 5: Open in new tabDownload slide Outpatient measurements of international normalized ratio, mean arterial pressure and lactate dehydrogenase. HM3: HeartMate 3; HW: HeartWare HVAD. Figure 5: Open in new tabDownload slide Outpatient measurements of international normalized ratio, mean arterial pressure and lactate dehydrogenase. HM3: HeartMate 3; HW: HeartWare HVAD. There was a trend towards more driveline infections in HM3 patients (0.68 vs 0.8 events per patient-year, P = 0.0704). The 1-year survival was similar in both groups [62.2%, 95% confidence interval (CI) (0.53–0.73) vs 66.7%, 95% CI (0.58–767), P = 0.372]. The Kaplan–Meier analysis regarding survival is shown in Fig. 6. The HRs, CIs and P-values are presented in Table 2. Figure 6: Open in new tabDownload slide Kaplan–Meier analysis of survival in both groups. HM3: HeartMate 3; HW: HeartWare HVAD. Figure 6: Open in new tabDownload slide Kaplan–Meier analysis of survival in both groups. HM3: HeartMate 3; HW: HeartWare HVAD. Open in new tabDownload slide Open in new tabDownload slide DISCUSSION The present retrospective single-centre observational study demonstrated similar survival in the first year after implantation of the HW and HM3. Furthermore, the incidence of all pump-related complications requiring surgical intervention was similar in both groups. One important observation is that the 2 analysed pumps have different complication profiles. While the HW was associated with a higher incidence of pump thrombosis requiring lysis or pump exchange, the HM3 more often exhibited a twist of the outflow graft requiring surgical revision. Furthermore, patients supported with the HW presented with more intracranial bleeding episodes, while the probability of ischaemic stroke was similar in both groups. For logistic reasons, the 2 device types were used alternatingly to reduce a systematic bias in the pump selection. However, there were differences in the preoperative status between the groups—more HW patients were in cardiogenic shock as reflected by a significantly lower INTERMACS status. The reason may be the surgeon’s choice to implant HW in high-risk cases (e.g. being on temporary ECLS, cachexia and congenital heart disease) because of its smaller size, thus facilitating implantation in complex cases, and the greater experience with this device at our institution. We have been implanting HW since September 2009 and participated in the CE-mark trial for the HM. We have been using this durable device since it became commercially available in Germany. The longer experience may indicate a preferential use of HVAD in high-risk cases because of its smaller size and its simple, fast implantation compared with HeartMate3. The significantly lower INTERMACS level in the HW group reflects this bias in part. More haemocompatibility-related adverse events in the HW group may be due to the lower INTERMACS status. However, it remains unclear to us how this constellation may lead to a higher incidence of haemorrhagic stroke in HW patients, since the difference was detected after 1 year on support. The results obtained in our retrospective analysis of the complication profiles are in line with the published results of the prospective Momentum trial. In this trial, no differences in survival or in the incidence of disabling stroke were found between the HM3 and the HM II. In the HM3 CE mark study, the survival after 12 months was 81% [11], and in the Momentum 3 trial, the 1-year survival was 86.6% [4]. However, a direct comparison of our data with those from the Momentum 3 and Endurance trials is not expedient since, in Momentum 3, data from patients with an INTERMACS level I amounted to <5%, while in our study, patients of all levels were included and, therefore, 37% and 26% of patients were classified as having INTERMACS level I, mostly on ECLS or Impella support. Finally, based on the present study, we were unable to identify any properties that would allow a selection of the pump tailored to the individual patient. Only 1 feature—the smaller size of the HW—offers a definite advantage in patients with a smaller stature and allows implantation in children weighing <20 kg [12], even in a biventricular fashion [13]. In our opinion, only a prospective, multicentre, randomized study can ultimately gather evidence about differences in the performance of the 2 pumps and allow pump selection to be based on the clinical situation of each individual patient. Limitations This is a single-centre, retrospective analysis with a 1-year follow-up. In our centre, the percentage of patients in INTERMACS I and II is much higher than in the Endurance and Momentum 3 trials. This may be a reason for the lower survival in our patients and may cause differences in the complications between the 2 pumps. Further studies are needed. CONCLUSION In our centre, and based on the current observational study, patients supported with the HW and HM3 pumps showed a different complication profile, but similar intermediate-term survival. A prospective, randomized, multicentre study is required to confirm these results. Conflict of interest: Evgenij Potapov: Proctoring for Abbott and Medtronic; Christoph Starck: Adviser for Medtronic and Abbott; Volkmar Falk: Adviser for Medtronic and Abbott; Johanna Mulzer: Adviser for Medtronic; Marcus Mueller: Adviser for Medtronic; all: institutional travel grants. Author contributions Marcus Mueller: Conceptualization; Data curation; Investigation; Writing—original draft. Christoph Hoermandinger: Data curation; Investigation. Gregor Richter: Data curation; Investigation. Johanna Mulzer: Data curation. Dmytro Tsyganenko: Data curation. Thomas Krabatsch: Supervision. Christoph Starck: Data curation. Julia Stein: Validation. Felix Schoenrath: Data curation. Volkmar Falk: Supervision. Evgenij Potapov: Conceptualization. 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Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

Journal

European Journal of Cardio-Thoracic Surgery – Oxford University Press

Published: Jun 1, 2020

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