Current risks of HeartMate II pump thrombosis: Non-parametric analysis of Interagency Registry for Mechanically Assisted Circulatory Support data

Smedira, Nicholas G.; Blackstone, Eugene H.; Ehrlinger, John; Thuita, Lucy; Pierce, Christopher; Moazami, Nader; Starling, Randall C.

doi:10.1016/j.healun.2015.10.027

Cited by 58 publications

(25 citation statements)

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“…In their study, 56% of patients received an LVAD exchange through a median sternotomy. Other groups have also reported a >70% of survival rate at 3 months following HeartMate II exchange 27. Our data is in line with previous reports demonstrating promising short-term survival in patients who undergo device exchange.…”

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confidence: 92%

Outcomes following left ventricular assist device exchange

et al. 2020

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Introduction Left ventricular assist device (LVAD) exchange has been historically associated with a significant risk of morbidity and mortality. It is unknown, however, whether these outcomes have improved. We aimed to compare clinical outcomes following LVAD exchange to those following initial LVAD implant in a contemporary patient cohort. Methods A total of 115 LVAD patients were enrolled between 2014 and 2017 and followed for 1 year. Of these, 15 patients (54.5 ± 13.3 years old, 87% male) underwent LVAD exchange at 277 (IQR 191‐597) days following LVAD implantation and 100 patients (57.5 ± 12.3 years old, 76% male) did not undergo an LVAD exchange (non‐exchange group). Results One‐year survival rate following LVAD exchange tended to be higher than the non‐exchange patients (93% vs 76%, P = .15). Readmission rates for each comorbidity did not significantly differ between the two groups (P > .05 for all) except for the higher rate of pump thrombosis in the LVAD exchange group (P < .05). Discussion LVAD exchange cohorts seem to have comparable clinical outcome with the non‐exchange cohorts. Conclusion LVAD exchange might be an increasingly appropriate therapeutic option for the management of pump thrombosis, although careful monitoring for recurrent pump thrombosis is required.

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confidence: 92%

Outcomes following left ventricular assist device exchange

et al. 2020

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“…However, experience has suggested that such attempts may be associated with improvement in 1 domain (eg, reduced anticoagulation bridging and running the pump in parallel, rather than in series, to decrease gastrointestinal bleeding) while yielding a worsening in a second critical domain (eg, a surge in pump thrombosis). [14][15][16][17] Nevertheless, attention has shifted to the role of both antiplatelet and anticoagulation protocols in managing the LVAS. A European experience demonstrated that an aspirin-free protocol was not related to an increased rate of thromboembolic adverse events in HMII-treated patients.…”

Section: Discussionmentioning

confidence: 99%

Hemocompatibility-Related Outcomes in the MOMENTUM 3 Trial at 6 Months

et al. 2017

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BACKGROUND:The HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) (Abbott) is a centrifugal, fully magnetically levitated, continuous-flow blood pump engineered to enhance hemocompatibility and reduce shear stress on blood components. The MOMENTUM 3 trial (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) compares the HM3 LVAS with the HeartMate II (HMII) LVAS (Abbott) in advanced heart failure refractory to medical management, irrespective of therapeutic intention (bridge to transplant versus destination therapy). This investigation reported its primary outcome in the short-term cohort (n=294; 6-month follow-up), demonstrating superiority of the HM3 for the trial primary end point (survival free of a disabling stroke or reoperation to replace the pump for malfunction), driven by a reduced need for reoperations. The aim of this analysis was to evaluate the aggregate of hemocompatibilityrelated clinical adverse events (HRAEs) between the 2 LVAS. METHODS:We conducted a secondary end point evaluation of HRAE (survival free of any nonsurgical bleeding, thromboembolic event, pump thrombosis, or neurological event) in the short-term cohort (as-treated cohort n=289) at 6 months. The net burden of HRAE was also assessed by using a previously described hemocompatibility score, which uses 4 escalating tiers of hierarchal severity to derive a total score for events encountered during the entire follow-up experience for each patient. RESULTS:In 289 patients in the as-treated group (151 the HM3 and 138 the HMII), survival free of any HRAE was achieved in 69% of the HM3 group and in 55% of the HMII group (hazard ratio, 0.62; confidence interval, 0.42-0.91; P=0.012). Using the hemocompatibility score, the HM3 group demonstrated less pump thrombosis requiring reoperation (0 versus 36 points, P<0.001) or medically managed pump thrombosis (0 versus 5 points, P=0.02), and fewer nondisabling strokes (6 versus 24 points, P=0.026) than the control HMII LVAS. The net hemocompatibility score in the HM3 in comparison with the HMII patients was 101 (0.67±1.50 points/patient) versus 137 (0.99±1.79 points/ patient) (odds ratio, 0.64; confidence interval, 0.39-1.03; P=0.065). CONCLUSIONS:In this secondary analysis of the MOMENTUM 3 trial, the HM3 LVAS demonstrated greater freedom from HRAEs in comparison with the HMII LVAS at 6 months. CLINICAL TRIAL REGISTRATION: 2004H emocompatibility-related adverse events (HRAEs) are the Achilles heel of the interaction between a left ventricular assist system (LVAS) and its biological circulatory interface.1 The constellation of device-related hemolysis, pump thrombosis leading to malfunction, neurological events (predominantly stroke and bleeding), and nonsurgical bleeding (particularly gastrointestinal bleeding) are the principal concerns that influence outcomes in mechanical circulatory support. These frequent complications are noted to occur with all contemporary centrifugal and axial continuous-flow devices, the HeartWare ...

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“…Currently, medical management of pump thrombosis has significant mortality (~48% at 6 months), and pump replacement carries risks exceeding those of primary implants . An INTERMACS report showed lower survival at 2 years, as well as increased incidence of infection and stroke in patients undergoing pump exchange for thrombosis compared with those receiving a primary LVAD implant .…”

Section: Discussionmentioning

confidence: 99%

“…Pump thrombosis was assessed parametrically using a multiphase temporal decomposition hazard model . This parametric model is useful because of the nonproportional hazard nature of the risk of pump thrombosis …”

Section: Methodsmentioning

confidence: 99%

“…Analysis of Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) data confirmed these findings . Although the recent 2 year prespecified analysis from the MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 trial demonstrated the suspected or confirmed pump thrombosis was lower with the centrifugal‐flow HeartMate 3 compared with the axial‐flow HMII (1.1 vs. 15.7%, respectively, P < 0.001), LVAD thrombosis is associated with substantial mortality and morbidity, including stroke, worsening heart failure, need for LVAD exchange or urgent transplantation, and peripheral embolism . Therefore, there is an urgent need for earlier diagnosis to permit timely decision making and effective intervention that may avert adverse outcomes.…”

Section: Introductionmentioning

confidence: 93%

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Dynamic prediction of left ventricular assist device pump thrombosis based on lactate dehydrogenase trends

et al. 2019

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AimsThe risk of HeartMate II (HMII) left ventricular assist device (LVAD) thrombosis has been reported, and serum lactate dehydrogenase (LDH), a biomarker of haemolysis, increases secondary to LVAD thrombosis. This study evaluated longitudinal measurements of LDH post‐LVAD implantation, hypothesizing that LDH trends could timely predict future LVAD thrombosis.Methods and resultsFrom October 2004 to October 2014, 350 HMIIs were implanted in 323 patients at Cleveland Clinic. Of these, patients on 339 HMIIs had at least one post‐implant LDH value (7996 total measurements). A two‐step joint model combining longitudinal biomarker data and pump thrombosis events was generated to assess the effect of changing LDH on thrombosis risk. Device‐specific LDH trends were first smoothed using multivariate boosted trees, and then used as a time‐varying covariate function in a multiphase hazard model to analyse time to thrombosis. Pre‐implant variables associated with time‐varying LDH values post‐implant using boostmtree were also investigated. Standardized variable importance for each variable was estimated as the difference between model‐based prediction error of LDH when the variable was randomly permuted and prediction error without permuting the values. The larger this difference, the more important a variable is for predicting the trajectory of post‐implant LDH. Thirty‐five HMIIs (10%) had either confirmed (18) or suspected (17) thrombosis, with 15 (43%) occurring within 3 months of implant. LDH was associated with thrombosis occurring both early and late after implant (P < 0.0001 for both hazard phases). The model demonstrated increased probability of HMII thrombosis as LDH trended upward, with steep changes in LDH trajectory paralleling trajectories in probability of pump thrombosis. The most important baseline variables predictive of the longitudinal pattern of LDH were higher bilirubin, higher pre‐implant LDH, and older age. The effect of some pre‐implant variables such as sodium on the post‐implant LDH longitudinal pattern differed across time.ConclusionsLongitudinal trends in surveillance LDH for patients on HMII support are useful for dynamic prediction of pump thrombosis, both early after implant and late. Incorporating upward and downward trends in LDH that dynamically update a model of LVAD thrombosis risk provides a useful tool for clinical management and decisions.

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Current risks of HeartMate II pump thrombosis: Non-parametric analysis of Interagency Registry for Mechanically Assisted Circulatory Support data

Cited by 58 publications

References 19 publications

Outcomes following left ventricular assist device exchange

Outcomes following left ventricular assist device exchange

Hemocompatibility-Related Outcomes in the MOMENTUM 3 Trial at 6 Months

Dynamic prediction of left ventricular assist device pump thrombosis based on lactate dehydrogenase trends

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