Results of non-elective withdrawal of continuous-flow left ventricular assist devices in selected patients.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Results from a multicentre evaluation of plug use for left ventricular assist device explantation.

OBJECTIVES: Myocardial recovery allows for left ventricular assist device (LVAD) explantations after long-term support. Several surgical approaches, including interventional decommissioning, off-pump explantation using a custom-made plug and complete LVAD removal through redo sternotomy, have been described. We present the results from an evaluation of the long-term follow-up of patients who received a titanium sintered plug after LVAD explantation. METHODS: We performed a retrospective, European, multicentre analysis of patients who received a titanium sintered plug to seal the apical fixation ring after LVAD explantation. Data were collected from a questionnaire that included demographics, procedural details and follow-up information. RESULTS: Out of 54 contacted centres in 12 countries (n = 179 patients), a total of 68 patients were successfully included in the study. The median follow-up was 34 months (interquartile range: 17-58.5 months); 57 (84%) patients had >1-year follow-up. At the time of the last follow-up, 55 (81%) patients were alive, with a Kaplan-Meier 1-year survival of 90.1% (95% confidence interval: 84.0-98.1%) and a 5-year survival of 80.0% (95% confidence interval: 68.4-92.9%). One patient (1.5%) developed a plug infection originating from an infected part of the incorporated driveline and, after complete removal, is currently in good condition. No postoperative stroke has been reported after plug implantation. CONCLUSIONS: In this European multicentre study, the use of a custom-made titanium plug to close the apical fixation ring after LVAD explantation resulted in a low incidence of plug-related complications. With the volume of patients undergoing LVAD explantations after myocardial recovery increasing, the plug has evolved as a simple alternative to more invasive device explantation procedures or decommissioning with a high risk for infection of the remaining system or stroke.

Impact of extra-corporeal life support (ECLS) cannulation strategy on outcome after durable mechanical circulation support system implantation on behalf of durable MCS after ECLS Study Group.

BACKGROUND: The literature on outcomes of patients requiring durable mechanical circulatory support (MCS) after extra-corporeal life support (ECLS) is limited. The aim of this study was to investigate the impact of preoperative ECLS cannulation on postoperative outcome after durable MCS implantation. METHODS: The durable MCS after ECLS registry is a multicenter retrospective study that gathered data on consecutive patients who underwent durable MCS implantation after ECLS between January 2010 and August 2018 in eleven high volume European centers. Patients who underwent the implantation of total artificial heart, pulsatile pumps, or first-generation pumps after ECLS were excluded from the analysis. The remaining patients were divided into two groups; central ECLS group (cECLS) and peripheral ECLS group (pECLS). A 1:1 propensity score analysis was performed to identify two matched groups. The outcome of these two groups was compared. RESULTS: A total of 531 durable MCS after ECLS were implanted during this period. The ECLS cannulation site was peripheral in 87% (n=462) and central in 13% (n=69) of the patients. After excluding pulsatile pumps and total artificial heart patients, a total of 494 patients remained (pECLS =434 patients, cECLS =60 patients). A 1:1 propensity score analysis resulted in 2 matched groups (each 55 patients) with median age of 54 years (48-60 years) in cECLS group and 54 years (43-60 years) in pECLS group. HeartWare HVAD (Medtronic, Minneapolis, MN) was implanted in the majority of the patients (cECLS =71% vs. pECLS =76%, P=0.67). All postoperative morbidities were comparable between the groups. The thirty-day, one year and long-term survival was comparable between the groups (P=0.73). CONCLUSIONS: The cannulation strategy of ECLS appears to have no impact on the post-operative outcome after durable MCS implantation.

Transition From Temporary to Durable Circulatory Support Systems.

BACKGROUND: The decision to implant durable mechanical circulatory systems (MCSs) in patients on extracorporeal life support (ECLS) is challenging due to expected poor outcomes in these patients. OBJECTIVES: The aim of this study was to identify outcome predictors that may facilitate future patient selection and decision making. METHODS: The Durable MCS after ECLS registry is a multicenter retrospective study that gathered data on consecutive patients who underwent MCS implantation after ECLS between January 2010 and August 2018 in 11 high-volume European centers. Several perioperative parameters were collected. The primary endpoint was survival at 1 year after durable MCS implantation. RESULTS: A total of 531 durable MCSs after ECLS were implanted during this period. The average patient age was 53 ± 12 years old. ECLS cannulation was peripheral in 87% of patients and 33% of the patients had history of cardiopulmonary resuscitation before ECLS implantation. The 30-day, 1-year, and 3-year actuarial survival rates were 77%, 53%, and 43%, respectively. The following predictors for 1-year outcome have been observed: age, female sex, lactate value, Model of End-Stage Liver Disease XI score, history of atrial fibrillation, redo surgery, and body mass index >30 kg/m2. On the basis of this data, a risk score and an app to estimate 1-year mortality was created. CONCLUSIONS: The outcome in patients receiving durable MCS after ECLS remains limited, yet preoperative factors may allow differentiating futile patients from those with significant survival benefit.

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

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 (0.58­0.767) [corrected]. CONCLUSIONS: Our data show that the complication profile differs between the 2 pumps, but that early survival is comparable.

Impact of preoperative atrial fibrillation on thromboembolic events and pump thrombosis in long-term left ventricular assist device therapy.

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.

Temporary mechanical circulatory support for refractory heart failure: the German Heart Center Berlin experience.

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.

Predictors of mid-term outcomes in patients undergoing implantation of a ventricular assist device directly after extracorporeal life support.

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.