Global best practices consensus: Long-term management of patients with hybrid centrifugal flow left ventricular assist device support

Hayward, Christopher; Adachi, Iki; Baudart, Sylvie; Davis, Erin; Feller, Erika; Kinugawa, Koichiro; Klein, Liviu; Li, Song; Lorts, Angela; Mahr, Claudius; Mathew, Jacob; Morshuis, Michiel; Müller, Marcus; Ōno, Minoru; Pagani, Francis D.; Pappalardo, Federico; Rich, Jonathan D.; Robson, D.; Rosenthal, David N.; Saeed, Diyar; Salerno, Christopher T.; Sauer, Andrew J.; Schlöglhofer, Thomas; Tops, Laurens F.; VanderPluym, Christina

doi:10.1016/j.jtcvs.2022.03.035

Cited by 11 publications

(6 citation statements)

References 92 publications

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“…Further, the unintuitive design of the driveline cable connector resulted in a median pump-off time > 30 s conducting the emergency controller exchange. During this period, patients would be solely dependent on their residual cardiac function, which may be too long to remain conscious, emphasizing that controller exchanges should not be performed by patients themselves without caregivers [ 30 ].…”

Section: Discussionmentioning

confidence: 99%

Human Factors Evaluation of HeartMate 3 Left Ventricular Assist Device Peripherals: An Eye Tracking Supported Simulation Study

et al. 2023

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Background Despite recent design improvements, human factors issues continue to challenge left ventricular assist device (LVAD) therapy. The aim of this study was to evaluate user experience of former non-HeartMate 3 (HM3) LVAD patients post heart transplantation (HTX) and laypersons (LP) with HM3 LVAD peripherals in simulated everyday and emergency scenarios. Methods This single center cohort study included untrained HTX and LP. Seven scenarios, including battery exchanges (without alarm, advisory alarm, dim light, consolidated bag), change of power supply, driveline dis-/reconnection and controller exchange were simulated. Subjects’ gaze behavior was recorded using eye tracking technology. Success rate, pump-off-time, duration to success (DTS), percental fixation duration per areas of interest and post-scenario-survey results were defined as outcome measures. Results Thirty subjects completed 210 scenarios, initially solving 82.4% (HTX vs. LP, p = 1.00). Changing power supply revealed highest complexity (DTS = 251 ± 93s, p = 0.76): 26.7% succeeded at first attempt (p = 0.68), 56.7% at second attempt, with significantly more LP failing (p = 0.04), resulting in 10 hazards from driveline disconnections (pump-off-time 2-118s, p = 0.25). Comparison on initial success showed differences in fixation durations for seven areas of interest (p < 0.037). Decreasing DTS during battery exchanges (p < 0.001) indicate high learnability. Exchanging batteries within the bag took longer (median DTS = 75.0 (IQR = 45.0)s, p = 0.09), especially in elderly subjects (r = 0.61, p < 0.001). Subjects with less initial success were more afraid of making mistakes (p = 0.048). Conclusion This eye tracking based human factors study provided insights into user experiences in handling HM3 peripherals. It highlights unintuitive and hazardous characteristics, providing guidance for future user-centered design of LVAD wearables.

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Section: Discussionmentioning

confidence: 99%

Human Factors Evaluation of HeartMate 3 Left Ventricular Assist Device Peripherals: An Eye Tracking Supported Simulation Study

et al. 2023

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“…Treatment success has previously been defined as patients alive and free from recurrent PT, stroke, device exchange or urgent transplantation at 30 days follow-up ( 6 , 7 ). Although there is experience with systemic thrombolysis for the treatment of PT, the regimen used varies among different centers and success rate depends on early recognition of PT ( 12 ). In our study, medical therapy, using a structured thrombolysis protocol, was successful in 10 of 14 patients (71%) at 30 days, whereas the recent meta-analysis reported a much lower success rate of 45% for medical therapy ( 7 ).…”

Section: Discussionmentioning

confidence: 99%

“…The current findings are of particular relevance given the recent withdrawal of the HeartWare LVAD system of the market by Medtronic ( 13 ). A substantial number of the 4000 living patients have their HeartWare LVAD as DT , and exchange to a HeartMate 3 may be challenging in this vulnerable patient population ( 12 ). The exchange from HeartWare LVAD to a HeartMate 3 is surgically and technically feasible, but the surgery is more complex than just a regular exchange from HeartWare to HeartWare and the redo surgery per se is associated with increased post-operative risks and mortality.…”

Section: Discussionmentioning

confidence: 99%

Systemic thrombolysis in the management of pump thrombosis in patients with left ventricular assist devices

Kortekaas

Exter

Beeres

et al. 2022

Front. Cardiovasc. Med.

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Left ventricular assist device (LVAD) implantation as destination therapy (DT) is a valuable treatment option in patients with end-stage heart failure ineligible for heart transplant. However, this therapy can be complicated by life-threatening pump thrombosis (PT). This case series reports our single-center experience with a structured systemic thrombolysis protocol in case of PT. Consecutive patients undergoing DT LVAD (HVAD, Medtronic, Framingham, MA) implantation between 2010 and April 2021 at our institution were reviewed and those with PT identified. Clinical, laboratory and LVAD specific data were collected and analyzed retrospectively. All patients with PT were treated with systemic thrombolysis according to a structured bedside protocol. Treatment was defined successful if a patient was alive at 30 days follow-up and free of recurrent PT, stroke or device exchange. Fourteen out of 94 patients experienced a PT after LVAD implantation (11%). Systemic thrombolysis was successful in 10 of 14 patients (71%) at 30 days. Two patients died within 30 days due to a hemothorax and multi-organ failure. In three patients treatment was complicated by a major bleeding; twice a hemothorax (one fatal) and one right calf bleeding. No intracerebral hemorrhage was observed. Three patients experienced a thrombotic complication within 30 days; all recurrent PT. Eleven of the 14 DT patients were discharged home after a limited hospital stay after thrombolysis (average of 11 days). In conclusion, systemic thrombolysis may be a reasonable option for life-threatening PT in this vulnerable DT group in whom device exchange is often impossible due to comorbidity.

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“…First and foremost, proper patient selection and preoperative examination are essential. To detect any contraindications or circumstances that may impair the procedure's outcome, a complete assessment of the patient's health status, comorbidities, and risk factors should be performed [26]. Based on the features of the patient, customized treatment plans and tactics can be devised.…”

Section: Quality Improvement Initiativesmentioning

confidence: 99%

“…Secondly, standardized protocols and best practices should be followed during the perioperative period. These protocols may include infection prevention measures, hemodynamic management strategies, anticoagulation protocols, and weaning strategies [26]. Adherence to established guidelines and consensus statements can help ensure consistency and promote optimal patient outcomes.…”

Section: Quality Improvement Initiativesmentioning

confidence: 99%

Exploring Perfusion Safety: A Review of Clinical and Non-Clinical Factors with Emphasis on Quality Improvement

Butt

2023

J Cardiol Cardiovasc Res.

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This literature review examines perfusion safety in cardiothoracic surgery, with a primary focus on cardiopulmonary bypass (CPB) and circulatory devices. PRISMA guidelines were followed and various databases, including PubMed, MEDLINE, and Google Scholar, were searched using relevant keywords to identify pertinent studies and literature on the subject. The review traces the historical development of perfusion techniques and underscores the importance of equipment factors, personnel considerations, and perfusion management strategies in ensuring patient safety during CPB and circulatory device usage. Clinical aspects of perfusion safety, encompassing equipment safety features, temperature management, anticoagulation, and blood conservation, are discussed. Non-clinical aspects, including the implementation of standardized protocols, robust training structures, positive team dynamics, and the fostering of a safety-oriented culture, are also examined. Quality improvement initiatives for blood conservation, monitoring, and incident reporting are explored, along with an acknowledgment of the significant contributions of major perfusion societies and boards (AmSECT, SCPS, EBCP) in establishing standards and promoting excellence in the field. Challenges related to device design, patient selection, and perioperative management are addressed, highlighting the need for standardized practices and ongoing research to enhance perfusion safety. This comprehensive review underscores the enduring commitment to advancing perfusion safety and quality through systematic research, education, and collaborative efforts in cardiothoracic surgery.

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Global best practices consensus: Long-term management of patients with hybrid centrifugal flow left ventricular assist device support

Cited by 11 publications

References 92 publications

Human Factors Evaluation of HeartMate 3 Left Ventricular Assist Device Peripherals: An Eye Tracking Supported Simulation Study

Human Factors Evaluation of HeartMate 3 Left Ventricular Assist Device Peripherals: An Eye Tracking Supported Simulation Study

Systemic thrombolysis in the management of pump thrombosis in patients with left ventricular assist devices

Exploring Perfusion Safety: A Review of Clinical and Non-Clinical Factors with Emphasis on Quality Improvement

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