Berlin Heart EXCOR and ACTION post-approval surveillance study report

Zafar, Farhan; Conway, Jennifer; Bleiweis, Mark S.; Al-Aklabi, Mohammed; Ameduri, Rebecca; Barnes, Aliessa P.; Bearl, David W.; Buchholz, Holger; Church, Stephanie J.; Nhue, L.; Duffy, Vicky; Dykes, J.C.; Eghtesady, Pirooz; Fisher, Lauren; Friedland‐Little, Joshua M.; Fuller, Stephanie; Fynn‐Thompson, Francis; George, Kristen M; Gossett, Jeffrey G.; Griffiths, Eric; Griselli, Massimo; Hawkins, Beth; Honjo, Osami; Jeewa, Aamir; Joong, Anna; Kindel, Steven J.; Kouretas, Peter C.; Lorts, Angela; Machado, Desiree; Maeda, Keisuke; Maurich, Andrea; May, Lindsay J.; McConnell, Patrick I.; Mehegan, Mary; Mongé, Michael C.; Morales, D.L.; Murray, Jenna; Niebler, Robert A.; O’Connor, Matthew J.; Peng, David M.; Phelps, Christina; Philip, Joseph; Ploutz, Michelle; Profsky, Michael; Reichhold, Allison; Rosenthal, David N.; Said, Ahmed; Schumacher, K.; Si, Ming‐Sing; Simpson, Kathleen E.; Sparks, John W.; Louis, Jim St; Steiner, Marie; VanderPluym, Christina; Villa, Chet

doi:10.1016/j.healun.2021.01.010

Cited by 56 publications

(34 citation statements)

References 20 publications

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“…4 However, a recent single-center study showed risk reduction with modification of antithrombotic regimens, 5 and multicenter collaborative practices have contributed to the reduction in CVA rate from 30% to 15% with paracorporeal pulsatile devices. 1,6 Reported rates of hemorrhagic stroke and/or intracranial hemorrhage are 3-8% in adults supported with left ventricular assist devices (LVAD) [7][8][9] and 3%-6% in the pediatric VAD population. 1 The However, recently published data suggest that outcomes may be dependent on the type of bleed.…”

Section: Discussionmentioning

confidence: 99%

“…Historically, approximately 30% of pediatric patients with paracorporeal pulsatile devices (Berlin Heart ® EXCOR ® ) experienced at least 1 neurological event, the majority of which were ischemic strokes within 1 month of implantation 4 . However, a recent single‐center study showed risk reduction with modification of antithrombotic regimens, 5 and multicenter collaborative practices have contributed to the reduction in CVA rate from 30% to 15% with paracorporeal pulsatile devices 1,6 …”

Section: Discussionmentioning

confidence: 99%

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Neurosurgical intervention in children with ventricular assist devices: A single‐center case series review

Murray

Ramamoorthy

et al. 2021

Pediatric Anesthesia

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Background:The incidence of neurological complications related to ventricular assist devices (VAD) remains high and includes life-threatening conditions such as intracranial hemorrhage or ischemic stroke. Although no definitive management guidelines exist, operative interventions may be required for major neurological injuries.Aims: This case series describes the perioperative management of children at a single center who underwent neurosurgical procedures for major intracranial bleeds or ischemic strokes while on VAD support. Methods:A database review identified all pediatric VAD patients who underwent a neurosurgical procedure for an intracranial hemorrhage or ischemic stroke from April 2014 to January 2020. Data regarding patient characteristics, preoperative medical management, intraoperative anesthetic management, and postoperative outcomes were collected using retrospective chart review.Results: Ninety VADs were implanted in 78 patients. Five neurosurgical interventions were performed: four for intracranial hemorrhages and one for an ischemic stroke.All four patients with hemorrhages were receiving anticoagulation at the time of their event and the three patients on warfarin received emergent reversal with prothrombin concentrate complex and vitamin K. Three patients also received pre-procedural platelet transfusions. Two of the five procedures were emergent bedside external ventricular drain placements, and three were surgical operations. All three patients who underwent operative procedures received invasive hemodynamic monitoring and were supported with a combination of inotropes and afterload reduction. One patient required a massive blood product transfusion. The two patients who underwent external ventricular drain placement had no further surgical interventions and died from the severity of their neurological injuries. All three patients who underwent operative procedures survived to transplantation and discharge home. Conclusions:Perioperative concerns for the anesthesiologist include VAD hemodynamic management, bleeding, VAD thrombosis, and prevention of secondary brain injury. A systematic, multidisciplinary approach to management is paramount to attain favorable outcomes.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Neurosurgical intervention in children with ventricular assist devices: A single‐center case series review

Murray

Ramamoorthy

et al. 2021

Pediatric Anesthesia

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“…5 These to an 8%-10% absolute risk reduction in stroke, and 10% absolute risk reduction in death, in the post-market surveillance cohort. 13 Innovative surgical techniques have allowed for successful VAD support even in neonates with hypoplastic left heart syndrome. 14 There are several other practical ramifications of prolonged status 1A wait times in smaller children.…”

Section: Impact Of Region Of the United States On Time To Heart Trans...mentioning

confidence: 99%

Pediatric heart transplant waiting times in the United States since the 2016 allocation policy change

Williams

Lü

Sleeper

et al. 2022

American Journal of Transplantation

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We describe waiting times for pediatric heart transplant (HT) candidates after the 2016 revision to the US allocation policy. The OPTN database was queried for pediatric HT candidates listed between 7/2016 and 4/2019. Of the 1789 included candidates, 65% underwent HT, 14% died/deteriorated, 8% were removed for improvement, and 13% were still waiting at the end of follow-up. Most candidates were status 1A at HT (81%). Median wait times differ substantially by listing status, blood type, and recipient weight. The likelihood of HT was lower in candidates <25 kg and in those with blood type O; The <25 kg, blood type O subgroup experiences longer wait times and higher wait list mortality. For status 1A candidates, median wait times were 108 days (≤25 kg, blood type O), 80 days (≤25 kg, non-O), 47 days (>25 kg, O), and 24 days (>25 kg, non-O). We found that centers with more selective organ acceptance practices, based on a lower median Pediatric Heart Donor Assessment Tool (PH-DAT) score for completed transplants, experience longer status 1A wait times for their listed patients. These data can be used to counsel families and to select appropriate advanced heart failure therapies to support patients to transplant.

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“…16 In fact, it is the results of this study, both the encouraging and the worrying, which ultimately led to both the 2017 Food and Drug Administration (FDA) approval for pediatric use of the Berlin Heart EXCOR and the advances in anticoagulation, which have contributed to reducing stroke rate and improving outcomes. 17 It is important to acknowledge that the original Berlin Heart trial included some significant limitations. The inclusion criteria were quite strict, which limited the generalizability of the data and likely overestimated the benefit of the device during the investigational device exemption phase.…”

Section: The Berlin Heart Excor: a Useful Examplementioning

confidence: 99%