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J Thorac Cardiovasc Surg 2007;133:1573-1580
© 2007 The American Association for Thoracic Surgery

Cardiopulmonary Support and Physiology

Results of a multicenter clinical trial with the Thoratec Implantable Ventricular Assist Device^_*

^a Advocate Christ Medical Center, Oak Lawn, Ill
^b Papworth Hospital, Cambridge, UK
^c Heart Center NRW, Bad Oeynhausen, Germany
^d Ohio State University, Columbus, Ohio
^e University of Pittsburgh Medical Center, Pittsburgh, Pa
^f OSF St Francis Medical Center, Peoria, Ill
^g University of Rochester, Rochester, NY
^h Sacred Heart Medical Center, Spokane, Wash
ⁱ Thoratec Corporation, Pleasanton, Calif
^j University of California Medical Center, San Francisco, Calif.

Received for publication August 31, 2006; revisions received December 6, 2006; accepted for publication December 12, 2006.

^_* Address for reprints: Mark Slaughter, MD, Advocate Christ Medical Center, 4440 W 95th St, Suite 205, Oak Lawn, Il 60453. (Email: mscabg{at}aol.com).

	Abstract

Top Abstract Introduction Materials and Methods Results Discussion Appendix E1 References

 
Objective: The Thoratec Implantable Ventricular Assist Device (Thoratec Corporation, Pleasanton, Calif) can be used for univentricular or biventricular support in 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 Device. Twenty-four patients (62%) received left ventricular assist devices and 15 (38%) received biventricular assist devices. Indications included bridge to transplantation (n = 30) and postcardiotomy failure (n = 9). The control group included 100 patients from the Food and Drug Administration approval submissions for the paracorporeal version of the ventricular assist device.

Results: Twenty-eight male and 11 female patients, with mean age of 48 years (16–71 years) and body surface area of 1.9 m² (1.3–2.4 m²) were supported for 3938 patient-days (10.8 patient-years). Mean left ventricular assist device flow index on the first postoperative day was 2.5 ± 0.5 L/(min · m²). Mean duration of support was 101 days (9–597 days). Eighteen patients were discharged after a mean duration of 96 days. There were no ventricular assist device failures. Complications included 13 cases of bleeding requiring reexploration (33.3%), 1 embolic and 2 hemorrhagic strokes (7.7%), 5 driveline infections (12.8%), and 2 pocket infections (5%). Support to successful outcomes was 70% for bridge to transplantation and 67% for postcardiotomy recovery, versus historical results for the paracorporeal ventricular assist device of 69% for bridge to transplantation and 48% for postcardiotomy recovery.

Conclusion: The Thoratec Implantable Ventricular Assist Device is a new implantable pulsatile ventricular assist device that allows hospital discharge for patients as a bridge to transplantation or for postcardiotomy failure. It is the first Food and Drug Administration–approved implantable ventricular assist device with biventricular capability.

	Introduction

Top Abstract Introduction Materials and Methods Results Discussion Appendix E1 References

 
Considerable progress has been made during the last decades in the development of ventricular assist devices (VADs). Initially, failure to wean from cardiopulmonary bypass was the primary indication for VAD support.^1-5 The roles of VADs and artificial hearts have expanded, however, to encompass support of patients awaiting cardiac transplantation^5-13 and destination therapy as an alternative to optimal medical management.^14-16

The Thoratec Paracorporeal Ventricular Assist Device (PVAD; Thoratec Corporation, Pleasanton, Calif) is the mainstay of many mechanical circulatory support programs. Based on designs that date back to the 1970s,¹⁷ it was approved by the Food and Drug Administration (FDA) in 1995 for bridge to transplantation (BTT) 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 implantable electric left ventricular assist device (LVAD) systems are often selected for their wearable controllers and batteries, the PVAD’s simplicity, size, and biventricular capability make it the device of choice for many patients. As more patients have been supported with the PVAD for longer durations (longest: 3.3 years of biventricular support 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 designed solely for left ventricular support, there is a clinical need for implantable assist device options for patients with severe biventricular failure. The Thoratec Implantable Ventricular Assist Device (IVAD; Thoratec Corporation) was therefore developed, retaining as much in common with the PVAD system as possible. The system underwent a formal clinical trial and was FDA approved in 2004 on the basis of the results. This report provides the results of this clinical trial relative to a historical control group of patients with the Thoratec PVAD.

	Materials and Methods

Top Abstract Introduction Materials and Methods Results Discussion Appendix E1 References

 
Device
The Thoratec IVAD blood pump (Figure 1) was designed with incremental changes to the commercially available PVAD, facilitating implantation of the pump while retaining the basic flow path and pumping mechanisms.^18,19 The pump housing material was changed from polysulfone and stainless steel to a titanium alloy, and the Hall effect pump-full sensor was replaced with an infrared sensor to detect both pump full and pump empty. The cannulas were shortened and the driveline lengthened for implantability. No changes were made to the blood path geometry in the pump, and with the exception of the valve housings (changed from stainless steel to titanium alloy), the blood contacting materials are identical.

View larger version (120K): [in this window] [in a new window]   Figure 1. Implantable ventricular assist device has same internal flow path as paracorporeal ventricular assist device, but plastic housing is replaced with smooth, contoured, polished titanium housing for improved implantability, and driveline is extended and covered with polyester velour as percutaneous lead.

View larger version (66K): [in this window] [in a new window]   Figure E1. Implantable ventricular assist device is placed in preperitoneal position and is small enough to be used for univentricular (A) or biventricular (B) support. One percutaneous pneumatic driveline is tunneled for each ventricular assist device.

Eligible patients were 12 to 70 years of age with acute or chronic heart failure necessitating VAD support to achieve adequate flow. Study inclusion criteria were similar to current indications for BTT or postcardiotomy failure and were met before patient enrollment (Appendix E1). Patients were excluded for any of the following reasons: active systemic infection, hemodialysis or hemofiltration requirements, intolerance to anticoagulation or antiplatelet therapy, chronic liver disease, elevated serum creatinine (>4 mg/dL) or total bilirubin (>3 mg/dL), recent pulmonary embolus, severe cerebrovascular disease, cardiopulmonary resuscitation on the way to the operating room, and concurrent mechanical support with any other circulatory support devices.

Adverse event definitions used were in compliance with FDA requirements at the time of the initiation of the clinical trial. Because the original PVAD trial used adverse event definitions different from those used in the IVAD trial, the original PVAD data were reviewed and reclassified according to the definitions of the IVAD trial.

The study was carried out under the regulations for investigational device exemption of the FDA. Informed consent was obtained before study participation. Each study site obtained institutional review board or ethics committee approval before study initiation, and any country-specific approval was obtained before patient enrollment.

Surgical Implantation
The Thoratec IVAD was implanted through a standard median sternotomy approach. The pocket for the IVAD was developed below the left rectus muscle or between the left posterior rectus fascia and the peritoneum. The driveline was tunneled below the umbilicus and brought out the right midquadrant above the belt line. After heparinization, standard cardiopulmonary bypass was instituted. Generally, the inflow and outflow cannulas were inserted during cardiopulmonary bypass, with the heart decompressed and beating. Aortic crossclamping was not necessary, and left ventricular vents were used at the surgeon’s discretion. The 14-mm outflow graft was sewn to the ascending aorta on the greater curvature as an end-to-side anastomosis. Left ventricular apex cannulation was achieved in all patients with LVAD support. It was possible to cannulate the left atrium through the left atrial appendage or the right superior pulmonary vein with the atrial cannula for LVAD support. When a right ventricular assist device (RVAD) was necessary, the outflow graft was sewn as an end-to-side anastomosis to the pulmonary artery and the inflow cannula was inserted either into the right atrium or directly into the right ventricle. After connection of the inflow and outflow grafts to the pump, the patient was weaned from cardiopulmonary bypass and the heparin was fully reversed with protamine.

Patients were typically anticoagulated initially with heparin for the first or second postoperative day at a dosage of about 10 µg/(kg · min), gradually increasing to maintain a partial thromboplastin time of about 1.5 times control. Patients were switched to warfarin when able to tolerate oral medications at doses to keep the international normalized ratio at 2.5 to 3.5. Dextran, aspirin and dipyridamole were also used in some patients.

Statistical comparisons between groups were conducted with Fisher exact test for 2 x 2 categorical variables and an unpaired t test for continuous variables.

	Results

Top Abstract Introduction Materials and Methods Results Discussion Appendix E1 References

 
Baseline Demographics
A total of 39 patients were enrolled between October 2001 and June 2004. The baseline demographics were similar for the IVAD and PVAD cohorts (Table 1). The 28 men and 11 women ranged in age from 16 to 71 years (mean 48 years), had an average body surface area of 1.9 m² (1.3–2.4 m²), and an average weight of 75 kg (42–115 kg). Cardiac disease etiologies were ischemic (n = 13), idiopathic dilated cardiomyopathy (n = 18), other cardiomyopathy (n = 1 each for familial, viral, cocaine-induced, chemotherapy induced, and hypertrophic), myocarditis (n = 1), and unspecified (n = 2). Before implantation, 35 (90%) of the 39 patients were in New York Heart Association (NYHA) functional class IV, and all 39 patients had severely compromised hemodynamics (Table 1). Twenty-six patients had a history of arrhythmias, 8 had previous cardiac arrests, and 23 had previous cardiac surgery, automatic implantable cardioverter defibrillators, or biventricular pacers.

Functional Status
All discharged patients engaged in light-to-moderate physical activity after discharge, including walking, shopping, visiting family and friends, and entertainment. By week 8, 69% of the patients were in NYHA functional class I or II, a significant improvement from the 93% of patients in NYHA functional class IV before implantation. Average improvement was 1.8 functional classes, from an average of 3.9 at baseline to 2.1 at week 8.

Survival
Twenty-seven of the 39 patients (69%) were successfully supported to cardiac transplantation or device removal for myocardial recovery (Table 3), an overall survival similar to that in the PVAD trial and significantly better than the 0% survival in the non-VAD medically managed control group from the original PVAD study.²⁰ The postcardiotomy survival (67%) was similar to that for BTT (70%). One patient (3.3%) recovered ventricular function in the BTT arm and was weaned from the VAD, and 2 (22%) patients in the postcardiotomy arm received heart transplants, illustrating the challenge in identifying the ultimate patient outcome at the time of implantation. When divided into univentricular or biventricular IVAD support for BTT (Table 3B), 13 of the 16 patients receiving LVAD support (81%) and 8 of the 14 patients requiring BVAD support (57%) underwent transplantation or weaning. Twenty-two (81%) of the 27 patients who either underwent transplantation or were weaned from the device were alive 30 days after VAD removal. For postcardiotomy support, 6 (75%) of the 8 patients with LVAD support were weaned or underwent transplantation; the single patient with BVAD patient died. Twenty (91%) of the 22 patients who underwent cardiac transplantation were discharged alive from the hospital.

There were no serious IVAD failures, and no IVADs required replacement. There were 10 pump or cable malfunctions related to the loss of pump full or empty signals from the device. Patients with loss of the full signal had the system managed in fixed rate mode rather than automatic rate mode without consequence. There were 10 patients with battery, charger, or driver malfunctions, including excess noise or nuisance alarms. One driveline was noted to be broken during explantation, and 2 instances of kinked cannulas were reported.

There were 2 perioperative deaths (9%) after transplantation, 1 from right ventricular failure and pulmonary edema and 1 from multiorgan failure. Two patients weaned from IVAD support after postcardiotomy ventricular failure died before discharge from gangrenous bowel or multiple organ failure. Twelve patients died while supported by the device, 7 from multiple organ failure in the first 2 to 5 weeks, 2 from hemorrhagic cerebrovascular accident, 2 from sepsis, and 1 from a subdural hematoma after a fall while at home.

	Discussion

Top Abstract Introduction Materials and Methods Results Discussion Appendix E1 References

 
The results from this clinical trial demonstrate that the IVAD, an implantable version of the Thoratec PVAD system, has comparable survival and reduced complication rates relative to the PVAD and provides an additional option for patients with advanced heart failure who required support as a BTT or pending recovery of the native heart. All patients received sufficient blood flow to restore hemodynamic values. Major organ function improved, and stable pulsatile circulatory support was provided by the IVAD for as long as 18 months. There were significant improvements in patient functional status, with more than two thirds of patients in NYHA functional class I or II by the 8th week of support. Patients were successfully discharged from the hospital and were active until transplantation or cardiac recovery. This is the first successful clinical trial of an implantable circulatory support system providing biventricular assistance.

In this study, 70% of the combined LVAD and BVAD subgroups of patients treated with the IVAD for BTT had successful weaning or transplantation, an outcome similar to those reported in other multicenter BTT clinical trials, including those of the Thoratec PVAD (69%),²⁰ the HeartMate IP LVAD (71%),⁶ the HeartMate VE Left Ventricular Assist System (LVAS, 71%),¹⁰ the Novacor LVAS (78%),¹¹ and the Cardiowest Total Artificial Heart (79%).¹³ Patients who received the IVAD for isolated left ventricular support had an 81% survival to cardiac transplantation. Patients who required biventricular support had lower survival (57%), consistent with previous studies demonstrating that patients with increased severity of illness, especially with renal and hepatic failure, are more likely to require BVADs and thus be at higher risk for death than patients supported with isolated LVADs.^7,21,24 In previous studies, one center reported using Thoratec BVADs for all of their patients with good results,²² whereas other single centers with more than 100 implants with the Thoratec VAD have reported 30% to 50% of patients treated as BTT receiving BVADs.^8,23,24 These percentages, with patients selected because of the device’s biventricular capability, are typically higher than the 7% to 15% incidence of RVAD use in the clinical experience of implantable electric LVADs,^9-12 with patients selected with the goal of univentricular support. Improved patient selection and earlier implantation remain the key factors that could reduce the 25% to 35% mortality among patients who do not survive to transplantation with the use of any VAD.

All adverse events reported in the trial were anticipated, and most occurred within the first 30 days after implantation. This is consistent with findings reported in the previous Thoratec PVAD and HeartMate LVAS studies. Only 1 patient had an embolic stroke and 2 had hemorrhagic strokes during IVAD support, and there were no device failures. Infection remains a concern for patients receiving any LVAD system and accounted for most adverse events; device-related infections were limited in the IVAD study to 2 pocket infections and 5 driveline infections, however, and sepsis was reported as the cause of death in only 2 cases.

One recognized limitation of the IVAD study was that it used a historical control group from the original clinical trial of the PVAD for comparisons of outcomes and adverse events. Clearly, patient management has changed since that study was conducted more than a decade ago, which could have an effect on detailed comparisons between these groups. The PVAD cohort is a suitable comparison group, however, in that the design and intended use of the PVAD and IVAD are similar, both pumps use the same pneumatic power sources, and both trials used similar inclusion and exclusion criteria to enroll patients. Thus no concurrent control group was deemed necessary to establish the basic equivalence of the IVAD with the PVAD.

The selection process regarding which device is best suited for a given patient and when the IVAD would be the appropriate choice is becoming more complex, especially with the emergence of the newer continuous-flow LVADs, which also address the need for smaller devices. For those programs that are not able to keep multiple devices on the shelf or for centers with existing experience with the PVAD, the IVAD seems like a logical choice because of its versatility and use for both BTT and postcardiotomy shock. The IVAD would also be an appropriate option for patients with a high likelihood of needing biventricular support.

The principal need for an option for implantation of the Thoratec IVAD is to facilitate hospital discharge, improve postoperative management, and help patients with psychosocial issues and acceptance of the device. Although patients with PVADs can be and are now being discharged from the hospital,²⁵ in many cases implantation may be preferable for long-term support and for outpatient management. Paracorporeal placement is preferable for short-term support, for example for less than 30 days, and for smaller patients²⁶ and those with other anatomic placement issues. Although implantable rotary pumps are showing much promise as small and quiet alternatives to the large first-generation electric LVADs, the IVAD is the smallest and lightest pulsatile VAD and has less motion and a smaller driveline than the currently available electric pulsatile LVADs. On the other hand, electric LVADs have the advantage of wearability and may be preferable for large patients who need long-term support, so long as it is known that only left ventricular support will be required. It is generally believed that smaller devices with less motion and smaller, more flexible drivelines will result in fewer infections and greater ease of outpatient management. Although these long sought after clinical benefits from smaller devices were not clearly demonstrated in this initial pilot study, it is to be hoped that they will be seen with increased use and continued improvements in patient management.

The Thoratec IVAD has demonstrated the capability of providing univentricular and biventricular support in a wide range of patients with a body surface area as small as 1.3 m². Long-term cardiac support was provided for as long as 597 days, and patients were successfully discharged from the hospital to await cardiac transplantation or myocardial recovery. The IVAD operated reliably, and there were no reported device failures. The results of this study establish the Thoratec IVAD as a viable option for patients with end-stage heart failure.

	Appendix E1

Top Abstract Introduction Materials and Methods Results Discussion Appendix E1 References

 
Study Inclusion Criteria

To be enrolled, the patient had to meet criteria 1 and 2 and either 3 or 4:

1 The patient has body surface area greater than 1.3 m².

2 The patient remains in cardiac failure despite appropriate use of conventional therapies such as inotropic agents, vasodilators, or intra-aortic balloon pump, as documented by the following:

a Pulmonary capillary wedge pressure greater than 20 mm Hg and either

b Cardiac index less than 2.0 L/(min m²) or

c Mixed venous oxygen saturation less than 50% or

d Systolic arterial pressure less than 90 mm Hg, or mean arterial pressure less than 70 mm Hg.

3 The patient requires ventricular assist device support as bridge to transplantation and meets the following criteria:

a Fulfills cardiac transplantation requirements for the center and

b Has imminent risk of dying before donor heart procurement.

4 The postcardiotomy patient is unable to be weaned from cardiopulmonary bypass and requires ventricular assist device support pending myocardial recovery.

	Acknowledgments

 
The coauthors acknowledge the other IVAD Study Group Members: Nelson A. Burton, MD, Inova Fairfax Hospital, Annandale, Va; Kathy Magliato, MD, Cedars Sinai Medical Center, Los Angeles, Calif; James C. Spann, MD, St Francis Hospital, Tulsa, Okla; Olivier Bastien, MD, PhD, Hospices Civils de Lyon, Lyon, France; and Jack Copeland, MD, University of Arizona, Tucson, Ariz.

	Footnotes

 
^_* Thoratec Corporation, Pleasanton, Calif.

¹ A.E-B. reports consulting fees from World-Heart.

² D.J.F. reports employment by and equity ownership in Thoratec Corporation.

³ J.D.H. reports consulting fees from and equity ownership in Thoratec Corporation.

⁴ T.B.I. reports lecture fees from Thoratec Corporation.

⁵ R.L.K. reports fellowship support from Thoratec Corporation.

⁶ B.S. reports consulting and lecture fees from Thoratec Corporation and lecture fees from and equity ownership in ABIOMED, Inc.

⁷ S.S.T. reports consulting and lecture fees and grant support from Ventracor (UK) Pty Ltd.

	References

Top Abstract Introduction Materials and Methods Results Discussion Appendix E1 References

 

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Mark S. Slaughter Steven S. Tsui Aly El-Banayosy Benjamin C. Sun Robert L. Kormos Dale K. Mueller Timothy B. Icenogle J. Donald Hill Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Slaughter, M. S. Search for Related Content PubMed PubMed Citation Articles by Slaughter, M. S. Related Collections Mechanical Circulatory Assistance Transplantation - heart