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Protocols have been developed to identify patients for elective withdrawal of continuous-flow left ventricular device (cfLVAD) support. However, little is known about non-elective explantation or decommissioning of cfLVADs. A retrospective analysis of all patients who underwent left ventricular assist device (LVAD) explantation or decommissioning at a single center between 2002 and 2021 was performed. Sixty-one patients underwent withdrawal of a cfLVAD (HeartMate II [Abbott] n = 17, HeartMate 3 [Abbott] n = 2, HeartWare HVAD [Medtronic] n = 36, INCOR [Berlin Heart] n = 6). The median follow-up after withdrawal was 1,039 days. The survival at 5 years was 76.1% (95% CI: 64.2%-95.2%). Predictors of worse outcomes in univariate regressive analysis were the duration of heart failure and the age at LVAD implantation. Of the 61 patients, 40 underwent elective withdrawal following a specific protocol. The other twenty-one patients underwent non-elective withdrawal of the cfLVAD because of device infection (n = 12), device thrombosis (n = 6), device malfunction (n = 2) or due to acute intracerebral bleeding (n = 1), also with an excellent survival at 5 years of 81.3%. (95% CI: 63.8-1). The withdrawal was performed in these patients even though they did not fulfill established criteria for successful explantation or decommissioning like clinical stability (n = 21), left ventricular end-diastolic diameter ≤ 55 mm (n = 3), performance of right heart catheterization (n = 6), or pulmonary artery wedge pressure ≤ 15 mm Hg (n = 3). Non-elective withdrawal is possible in selected patients after discussion in a team of experienced cardiac surgeons, cardiologists, technicians, and VAD coordinators. The appropriate preoperative assessment before decommissioning or explantation of a cfLVAD warrants further investigation. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Open in new tab Download slide Open in new tab Download slide OBJECTIVES Pump thrombosis (PT) and thromboembolic events (TEs) remain major adverse events in left ventricular assist device (LVAD) therapy at an annual rate of 6–8% supported with the HeartWare HVAD and HeartMate II. PT and TEs are multifactorial events. Understanding the predisposing risk factors for PT and TE is paramount to define preventive strategies. Preoperative atrial fibrillation (AF) is considered a significant and potentially modifiable risk factor. This study investigates whether LVAD patients with AF exhibit a higher rate of PT and TE than those in sinus rhythm (SR). METHODS We evaluated medical records of consecutive patients who underwent implantation of the HeartMate II (n  = 195; 25.4%) and HeartWare HVAD (n  = 574; 74.6%) at our institution between 2006 and 2015. Only visually confirmed PT was included in the study. TE was defined as any peripheral embolism or cerebral embolism according to the INTERMACS definitions. RESULTS SR was documented preoperatively in 211 patients (SR group) and AF in 558 patients (AF group). The median duration of support was 0.78 years in the AF group and 1.03 years in the SR group. The mean age was 60.27 years in the AF group and 52.04 years in the SR group. In the AF group, 83.0% of the patients were male, compared to 77.3% in the SR group. The cumulative incidence of PT in the SR group was 2.5% [95% confidence interval (CI) 0.3–4.7%] after 1 year and 5.7% (95% CI 2.2–9.2%) after 2 years, and in the AF group 4.9% (95% CI 3.0–6.7%) and 7.8% (95% CI 5.4–10.2%), respectively (P  = 0.129). TEs were recorded in the SR group in 4.4% (95% CI 1.6–7.2%) after 1 year and in 6.3% (95% CI 2.8–9.8%) after 2 years, and occurred after a median support time of 214 days (range 120–768). In the AF group, the cumulative incidence was 8.4% (95% CI 6.0–10.7%) and 10.7% (95% CI 8.0–13.4%), respectively, after a median support time of 116 days (range 37–375), P -value = 0.163. In the multivariate analysis, event-free survival was not influenced by the preoperative SR [hazard ratio (HR) 0.86, 95% CI 0.68–1.1; P  = 0.19]. CONCLUSIONS Our study showed that the preoperative rhythm has no impact on survival, PT and TEs despite different preoperative risk factor profiles in the AF and SR group. Thus, the effect of a maze procedure, catheter ablation or left atrial appendage closure on PT and TE's for AF patients during LVAD implantation is questionable. However, to obtain a definitive answer, a prospective study would be of value. [ABSTRACT FROM AUTHOR]

View large Download slide View large Download slide OBJECTIVES Extracorporeal life support (ECLS) can be applied as a bridge to diagnosis and decision-making for further treatment with long-term left ventricular assist devices (LVADs). METHODS From January 2012 to January 2018, 714 adult patients were treated with ECLS in our institution. During the same period, 618 patients received an LVAD for long-term support. Of them, 100 patients were further supported with a long-term LVAD. We retrospectively analysed the datasets of these 100 consecutive patients with the goal of developing an algorithm to predict outcomes for a rational use of long-term ventricular assist device therapy in this setting. RESULTS The mean age of the 100 patients was 54.1 ± 11.6 years, and 72 were men. Twenty-nine patients had a BMI of >30 kg/m2. In 33 patients, a temporary right ventricular assist device was necessary postoperatively. The 30-day, 1-year and 2-year survival after ventricular assist device implantation was 62.0% [95% confidence interval (CI) 53.2–72.3], 43.0% (95% CI 34.3–53.9) and 37.1% (95% CI 28.2–48.7%), respectively. Penalized multivariable logistic regression analysis showed following predictors for 1-year mortality: bilirubin increase per mg/dl [odds ratio (OR) 1.41, 95% CI 1.12–1.77], C-reactive protein increase per mg/dl (OR 1.11, 95% CI 1.05–1.19), ECLS duration >7 days (OR 4.90, 95% CI 1.66–14.41), BMI >30 kg/m2 (OR 1.41, 95% CI 1.05–8.52) and female gender (OR 3.06, 95% CI 1.02–9.23). On the basis of these data, a nomogram to estimate 1-year mortality after LVAD implantation was created. CONCLUSIONS After stabilization of patients experiencing cardiogenic shock using ECLS, LVAD implantation can be performed with elevated mortality in an otherwise futile situation. Liver dysfunction, inflammatory status and obesity increase the risk for mid-term mortality. [ABSTRACT FROM AUTHOR]