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First report of 90-day support of 2 calves with a continuous-flow total artificial heart.

ABSTRACT: The Cleveland Clinic continuous-flow total artificial heart (CFTAH) is a compact, single-piece, valveless, pulsatile pump providing self-regulated hemodynamic output to left/right circulation. We evaluated chronic in vivo pump performance, physiologic and hemodynamic parameters, and biocompatibility of the CFTAH in a well-established calf model.CFTAH pumps have been implanted in 17 calves total. Hemodynamic parameters, pump performance, and device-related adverse events were evaluated during studies and at necropsy.In vivo experiments demonstrated good hemodynamic performance (pump flow, 7.3 ± 0.7 L/min; left atrial pressure, 16 ± 3 mm Hg; right atrial pressure, 17 ± 3 mm Hg; right atrial pressure-left atrial pressure difference, 1 ± 2 mm Hg; mean arterial pressure, 103 ± 7 mm Hg; arterial pulse pressure, 30 ± 11 mm Hg; and pulmonary arterial pressure, 34 ± 5 mm Hg). The CFTAH has operated within design specifications and never failed. With ever-improving pump design, the implants have shown no chronic hemolysis. Three animals with recent CFTAH implantation recovered well, with no postoperative anticoagulation, during planned in vivo durations of 30, 90, and 90 days (last 2 were intended to be 90-day studies). All these longest-surviving cases showed good biocompatibility, with no thromboembolism in organs.The current CFTAH has demonstrated reliable self-regulation of hemodynamic output and acceptable biocompatibility without anticoagulation throughout 90 days of chronic implantation in calves. Meeting these milestones is in accord with our strategy to achieve transfer of this unique technology to human surgical practice, thus filling the urgent need for cardiac replacement devices as destination therapy.

SUBMITTER: Karimov JH

PROVIDER: S-EPMC4554829 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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First report of 90-day support of 2 calves with a continuous-flow total artificial heart.

Karimov Jamshid H JH Moazami Nader N Kobayashi Mariko M Sale Shiva S Such Kimberly K Byram Nicole N Sunagawa Gengo G Horvath David D Gao Shengqiang S Kuban Barry B Golding Leonard A R LA Fukamachi Kiyotaka K

The Journal of thoracic and cardiovascular surgery 20150618 3

<h4>Objective</h4>The Cleveland Clinic continuous-flow total artificial heart (CFTAH) is a compact, single-piece, valveless, pulsatile pump providing self-regulated hemodynamic output to left/right circulation. We evaluated chronic in vivo pump performance, physiologic and hemodynamic parameters, and biocompatibility of the CFTAH in a well-established calf model.<h4>Methods</h4>CFTAH pumps have been implanted in 17 calves total. Hemodynamic parameters, pump performance, and device-related advers ...[more]

PMID: 26173607

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Project description:BackgroundIn an effort to improve quality and reduce costs, reimbursement for total knee arthroplasty (TKA) and total hip arthroplasty (THA) in the United States is being based on the value of care provided, with adjustments for some qualifying comorbidities, including diabetes in its most severe form and excluding many diabetes codes. The aims of this study were to examine the effects of diabetes on elective TKA or THA complications and readmission risks among Medicare beneficiaries.MethodsComplication (n = 521,230) and readmission (n = 515,691) data were extracted from Medicare files in 2013 and 2014. Diabetes status (no diabetes, controlled-uncomplicated diabetes, controlled-complicated diabetes, and uncontrolled diabetes) was identified with ICD-9 (International Classification of Diseases, 9th Revision) codes. TKA or THA complications and readmission odds based on diabetes status were estimated using logistic regression and adjusted for sociodemographic and clinical characteristics, including comorbidities.ResultsCompared with no diabetes, the odds ratio (OR) of TKA complications was significantly higher for uncontrolled diabetes (1.29, 95% confidence interval [CI] = 1.06 to 1.57). The OR of THA complications was significantly higher for controlled-complicated diabetes (1.45, 95% CI = 1.17 to 1.80). The OR of readmission was significantly higher for all diabetes groups (1.21 to 1.48 for TKA, 1.20 to 1.70 for THA).ConclusionsReadmission odds were higher in all diabetes categories. The uncontrolled-diabetes group had the greatest TKA readmission and complication odds. The controlled-complicated diabetes group had the greatest THA readmission and complication odds. The findings suggest that including diabetes and associated systemic complications in cost adjustments in alternative payment models for arthroplasty should be considered.Level of evidencePrognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

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First report of 90-day support of 2 calves with a continuous-flow total artificial heart.

Publications

First report of 90-day support of 2 calves with a continuous-flow total artificial heart.

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