Unexpected Abrupt Increase in Left Ventricular Assist Device Thrombosis

Starling, Randall C.; Moazami, Nader; Silvestry, Scott C.; Ewald, Gregory A.; Rogers, Joseph G.; Milano, Carmelo A.; Rame, J. Eduardo; Acker, Michael A.; Blackstone, Eugene H.; Ehrlinger, John; Thuita, Lucy; Mountis, Maria; Soltesz, Edward G.; Lytle, Bruce W.; Smedira, Nicholas G.

doi:10.1056/nejmoa1313385

Cited by 713 publications

(478 citation statements)

References 13 publications

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“…However, despite the positive effects, device-related severe and potentially life-threatening complications are frequently observed [3][4][5][6]. Most of these complications such as thrombosis, embolism, outflow graft/graft stenosis or obstruction, arteriobronchial fistulae and pseudoaneurysms are traditionally managed surgically through a sternotomy and often by pump exchange.…”

Section: Discussionmentioning

confidence: 99%

Successful Treatment of LVAD Patient with Infection-Induced Pseudoaneurysm using Endovascular Stent Graft

Rustum¹,

Schmitto²,

Doğan³

et al. 2017

Vasc Med Surg

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Section: Discussionmentioning

confidence: 99%

Successful Treatment of LVAD Patient with Infection-Induced Pseudoaneurysm using Endovascular Stent Graft

Rustum¹,

Schmitto²,

Doğan³

et al. 2017

Vasc Med Surg

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“…Further treatment requires weighing the persistent thrombotic risk of the LVAD against the severity and acuity of bleeding. Newly published data, however, demonstrate that since 2011, there has been an increase in early device thrombosis in the first 3 months after implantation [7]; anticoagulation strategies are therefore currently undergoing intense re-evaluation [24]. There are concerns that holding anticoagulation for bleeding events may increase the risk of device thrombosis.…”

Section: Discussionmentioning

confidence: 99%

“…Other thrombotic manifestations include a 5.4% rate of VTE, and 1.3% rate of non-stroke arterial embolic events [1]. Review of outcomes over the past 2 years has found a significant increase in LVAD thrombosis within the first 3 months of implantation of the Heartmate II device [7].…”

Section: Anticoagulation Management Of Left Ventricular Assist Devicesmentioning

confidence: 99%

“…As noted above, however, review of the data since March 2011 has shown an increase in device thrombosis rates from 2.2% to 8.4% within the first 3 months following implantation [7]. It is unclear whether this reflects a change in the risk related to change in device components, changes in antithrombotic therapy, or is intrinsic to the procedure.…”

Section: Thrombosismentioning

confidence: 99%

“…Cardiologists use a combination of indicators to determine the presence of LVAD thrombosis. Evidence of increased red cell hemolysis based on an increase in the LDH of greater than 2.5 times the upper limit of normal and increased plasma hemoglobin above typical elevated baseline can point to early device thrombosis [7]. Power spikes can indicate rotor thrombosis but characteristic findings on ramp transthoracic echocardiogram are the mainstay of diagnosing LVAD thrombosis.…”

Section: Device Thrombosismentioning

confidence: 99%

See 2 more Smart Citations

Anticoagulation management of left ventricular assist devices

Connors

2014

American J Hematol

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Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial

Mehra

Goldstein

Cleveland

et al. 2022

JAMA

171

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ImportanceAlthough durable left ventricular assist device (LVAD) therapy has emerged as an important treatment option for patients with advanced heart failure refractory to pharmacological support, outcomes, including survival, beyond 2 years remain poorly characterized.ObjectiveTo report the composite end point of survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Scale score &gt;3) or reoperation to replace the pump 5 years after the implant in participants who received the fully magnetically levitated centrifugal-flow HeartMate 3 or axial-flow HeartMate II LVAD in the MOMENTUM 3 randomized trial and were still receiving LVAD therapy at the 2-year follow-up.Design, Setting, and ParticipantsThis observational study was a 5-year follow-up of the MOMENTUM 3 trial, conducted in 69 US centers, that demonstrated superiority of the centrifugal-flow LVAD to the axial-flow pump with respect to survival to transplant, recovery, or LVAD support free of debilitating stroke or reoperation to replace the pump at 2 years. A total of 295 patients were enrolled between June 2019 to April 2021 in the extended-phase study, with 5-year follow-up completed in September 2021.ExposuresOf 1020 patients in the investigational device exemption per-protocol population, 536 were still receiving LVAD support at 2 years, of whom 289 received the centrifugal-flow pump and 247 received the axial-flow pump.Main Outcomes and MeasuresThere were 10 end points evaluated at 5 years in the per-protocol population, including a composite of survival to transplant, recovery, or LVAD support free of debilitating stroke or reoperation to replace the pump between the centrifugal-flow and axial-flow pump groups and overall survival between the 2 groups.ResultsA total of 477 patients (295 enrolled and 182 provided limited data) of 536 patients still receiving LVAD support at 2 years contributed to the extended-phase analysis (median age, 62 y; 86 [18%] women). The 5-year Kaplan-Meier estimate of survival to transplant, recovery, or LVAD support free of debilitating stroke or reoperation to replace the pump in the centrifugal-flow vs axial-flow group was 54.0% vs 29.7% (hazard ratio, 0.55 [95% CI, 0.45-0.67]; P &lt; .001). Overall Kaplan-Meier survival was 58.4% in the centrifugal-flow group vs 43.7% in the axial-flow group (hazard ratio, 0.72 [95% CI, 0.58-0.89]; P = .003). Serious adverse events of stroke, bleeding, and pump thrombosis were less frequent in the centrifugal-flow pump group.Conclusions and RelevanceIn this observational follow-up study of patients from the MOMENTUM 3 randomized trial, per-protocol analyses found that receipt of a fully magnetically levitated centrifugal-flow LVAD vs axial-flow LVAD was associated with a better composite outcome and higher likelihood of overall survival at 5 years. These findings support the use of the fully magnetically levitated LVAD.Trial RegistrationClinicalTrials.gov Identifier: NCT02224755 and NCT03982979

show abstract

Unexpected Abrupt Increase in Left Ventricular Assist Device Thrombosis

Cited by 713 publications

References 13 publications

Successful Treatment of LVAD Patient with Infection-Induced Pseudoaneurysm using Endovascular Stent Graft

Successful Treatment of LVAD Patient with Infection-Induced Pseudoaneurysm using Endovascular Stent Graft

Anticoagulation management of left ventricular assist devices

Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial

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