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Results of a Multicenter Clinical Trial with the Thoratec Implantable Ventricular Assist Device*

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Results of a Multicenter Clinical Trial with the Thoratec Implantable Ventricular Assist Device* View metadata, citation and similar papers at core.ac.uk brought to you by CORE Slaughter et al Cardiopulmonary Support and Physiology provided by Elsevier - Publisher Connector Results of a multicenter clinical trial with the Thoratec Implantable Ventricular Assist Device* Mark S. Slaughter, MD,a Steven S. Tsui, MD,b Aly El-Banayosy, MD,c Benjamin C. Sun, MD,d Robert L. Kormos, MD,e Dale K. Mueller, MD,f H. Todd Massey, MD,g Timothy B. Icenogle, MD,h David J. Farrar, PhD,i and J. Donald Hill, MD,j on behalf of the IVAD Study Group Objective: The Thoratec Implantable Ventricular Assist Device (Thoratec Corpo- Supplemental material is ration, Pleasanton, Calif) can be used for univentricular or biventricular support in available online. patients with a body surface area as low as 1.3 m2. Results of the multicenter clinical trial are reviewed. Methods: Between October 2001 and June 2004, a total of 39 patients at 12 institutions were supported with the Thoratec Implantable Ventricular Assist De- vice. Twenty-four patients (62%) received left ventricular assist devices and 15 (38%) received biventricular assist devices. Indications included bridge to trans- plantation (n ϭ 30) and postcardiotomy failure (n ϭ 9). The control group included 100 patients from the Food and Drug Administration approval submissions for the paracorporeal version of the ventricular assist device. From Advocate Christ Medical Center, Oak Results: Twenty-eight male and 11 female patients, with mean age of 48 years a Lawn, Ill ; Papworth Hospital, Cambridge, (16–71 years) and body surface area of 1.9 m2 (1.3–2.4 m2) were supported for 3938 UKb; Heart Center NRW, Bad Oeynhausen, Germanyc; Ohio State University, Colum- patient-days (10.8 patient-years). Mean left ventricular assist device flow index on bus, Ohiod; University of Pittsburgh Medi- the first postoperative day was 2.5 Ϯ 0.5 L/(min · m2). Mean duration of support cal Center, Pittsburgh, Pae; OSF St Francis Medical Center, Peoria, Illf; University of was 101 days (9–597 days). Eighteen patients were discharged after a mean Rochester, Rochester, NYg; Sacred Heart duration of 96 days. There were no ventricular assist device failures. Complications Medical Center, Spokane, Washh; Thoratec included 13 cases of bleeding requiring reexploration (33.3%), 1 embolic and 2 Corporation, Pleasanton, Calif i; and Uni- versity of California Medical Center, San hemorrhagic strokes (7.7%), 5 driveline infections (12.8%), and 2 pocket infec- Francisco, Calif.j tions (5%). Support to successful outcomes was 70% for bridge to transplantation A.E-B. reports consulting fees from World- and 67% for postcardiotomy recovery, versus historical results for the paracorporeal Heart. D.J.F. reports employment by and ventricular assist device of 69% for bridge to transplantation and 48% for postcar- equity ownership in Thoratec Corporation. J.D.H. reports consulting fees from and eq- diotomy recovery. uity ownership in Thoratec Corporation. T.B.I. reports lecture fees from Thoratec Conclusion: The Thoratec Implantable Ventricular Assist Device is a new implant- Corporation. R.L.K. reports fellowship sup- port from Thoratec Corporation. B.S. re- able pulsatile ventricular assist device that allows hospital discharge for patients as ports consulting and lecture fees from Tho- a bridge to transplantation or for postcardiotomy failure. It is the first Food and Drug ratec Corporation and lecture fees from and Administration–approved implantable ventricular assist device with biventricular equity ownership in ABIOMED, Inc. S.S.T. reports consulting and lecture fees and capability. grant support from Ventracor (UK) Pty Ltd. Received for publication Aug 31, 2006; re- CSP visions received Dec 6, 2006; accepted for publication Dec 12, 2006. Address for reprints: Mark Slaughter, MD, onsiderable progress has been made during the last decades in the devel- Advocate Christ Medical Center, 4440 W opment of ventricular assist devices (VADs). Initially, failure to wean from 95th St, Suite 205, Oak Lawn, Il 60453 1-5 (E-mail: [email protected]). CcardiopulmonarybypasswastheprimaryindicationforVADsupport. *Thoratec Corporation, Pleasanton, Calif. The roles of VADs and artificial hearts have expanded, however, to encompass supportofpatientsawaitingcardiactransplantation5-13anddestinationtherapyasan J Thorac Cardiovasc Surg 2007;133:1573-80 alternativetooptimalmedicalmanagement.14-16 0022-5223/$32.00 The Thoratec Paracorporeal Ventricular Assist Device (PVAD; Thoratec Corpo- Copyright © 2007 by The American Asso- ciation for Thoracic Surgery ration, Pleasanton, Calif) is the mainstay of many mechanical circulatory support 17 doi:10.1016/j.jtcvs.2006.11.050 programs.Basedondesignsthatdatebacktothe1970s, itwasapprovedbythe Food and Drug Administration (FDA) in 1995 for bridge to transplantation (BTT) The Journal of Thoracic and Cardiovascular Surgery ● Volume 133, Number 6 1573 Cardiopulmonary Support and Physiology Slaughter et al Abbreviations and Acronyms BTT ϭ bridge to transplantation FDA ϭ Food and Drug Administration IVAD ϭ implantable ventricular assist device LVAD ϭ left ventricular assist device LVAS ϭ left ventricular assist system NYHA ϭ New York Heart Association PVAD ϭ paracorporeal ventricular assist device RVAD ϭ right ventricular assist device VAD ϭ ventricular assist device and in 1998 for postcardiotomy myocardial recovery. As of Jan 2006, more than 3000 patients have been supported for both indications with the Thoratec PVAD. Although im- plantable electric left ventricular assist device (LVAD) sys- tems are often selected for their wearable controllers and batteries, the PVAD’s simplicity, size, and biventricular Figure 1. Implantable ventricular assist device has same internal capability make it the device of choice for many patients. As flow path as paracorporeal ventricular assist device, but plastic housing is replaced with smooth, contoured, polished titanium more patients have been supported with the PVAD for housing for improved implantability, and driveline is extended longer durations (longest: 3.3 years of biventricular support and covered with polyester velour as percutaneous lead. without changing pumps), however, a need has arisen for an implantable version to facilitate patient discharge from the hospital and potentially improve quality of life. In addition, because implantable electric LVAD systems have been de- tricularsupport(FigureE1, A and B)ispossiblebyusingthe signed solely for left ventricular support, there is a clinical appropriate atrial or ventricular inflow cannula and arterial outflow need for implantable assist device options for patients with cannula. The IVAD, which weighs 339 g and has a displaced severe biventricular failure. The Thoratec Implantable Ven- volume of 252 mL, is slightly smaller and lighter than the PVAD tricular Assist Device (IVAD; Thoratec Corporation) was (weight 419 g, volume 318 mL) and can generate pulsatile flow up therefore developed, retaining as much in common with the to 7.2 L/min. PVAD system as possible. The system underwent a formal Methods clinical trial and was FDA approved in 2004 on the basis of The Thoratec IVAD was studied in a prospective, multicenter, the results. This report provides the results of this clinical nonrandomized clinical trial for use as a BTT or for patients in trial relative to a historical control group of patients with the postcardiotomy recovery who cannot be weaned from cardiopul- Thoratec PVAD. monary bypass. A total of 39 patients were enrolled at 9 centers in the United States and 3 in Europe. The primary study objective Materials and Methods was to evaluate the safety and effectiveness of the IVAD, as Device demonstrated by VAD flow index, survival, and adverse event CSP TheThoratecIVADbloodpump(Figure1)wasdesignedwith rates, and to establish basic equivalence with the PVAD. Survival incremental changes to the commercially available PVAD, facili- results and adverse events were compared with those among 100 tating implantation of the pump while retaining the basic flow path patients in the original clinical trial of the PVAD for BTT and for andpumpingmechanisms.18,19Thepumphousingmaterialwas postcardiotomymyocardialrecovery.20 changed from polysulfone and stainless steel to a titanium alloy, Eligible patients were 12 to 70 years of age with acute or and the Hall effect pump-full sensor was replaced with an infrared chronic heart failure necessitating VAD support to achieve ade- sensor to detect both pump full and pump empty. The cannulas quate flow. Study inclusion criteria were similar to current indi- were shortened and the driveline lengthened for implantability. cations for BTT or postcardiotomy failure and were met before No changes were made to the blood path geometry in the pump, patient enrollment (Appendix E1). Patients were excluded for any and with the exception of the valve housings (changed from of the following reasons: active systemic infection, hemodialysis stainless steel to titanium alloy), the blood contacting materials or hemofiltration requirements, intolerance to anticoagulation or are identical. antiplatelet therapy, chronic liver disease, elevated serum creati- The Thoratec IVAD was designed for preperitoneal placement nine (Ͼ4 mg/dL) or total bilirubin (Ͼ3 mg/dL), recent pulmonary and is pneumatically powered by an external portable TLC-II embolus, severe cerebrovascular disease, cardiopulmonary resus- Driver. A single percutaneous lead for each VAD is used for citation on the way to the operating room, and concurrent
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