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Ann Thorac Surg 1997;63:1458-1461
© 1997 The Society of Thoracic Surgeons

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Case Report

Permanent Mechanical Circulatory Support With an Implantable Left Ventricular Assist Device

Departments of Thoracic and Cardiovascular Surgery and Cardiology, The Cleveland Clinic Foundation, Cleveland, Ohio

Accepted for publication November 25, 1996.

	Abstract

Top Footnotes Abstract Introduction Comment Addendum Acknowledgments References

 
A 67-year-old man had end-stage ischemic cardiomyopathy. He had had two previous coronary bypass operations and a previous left ventricular aneurysmectomy. In December 1995 he underwent vented-electric HeartMate LVAD insertion as an alternative to transplantation. He was discharged from the hospital 13 days after the operation, and 5 months postoperatively he had returned to New York Heart Association functional class II.

	Introduction

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Permanent mechanical circulatory support for patients dying of end-stage heart disease began in December 1982 when Barney Clark received a Jarvik-7 total artificial heart. He never left the hospital, and died after 5 months of support. These widely publicized and controversial initial experiments were replaced by the temporary bridge-to-transplantation (BTT) use of the TAH, and permanent implantations ended in 1985 [1, 2]. In the following decade, clinical mechanical circulatory support evolved in concept and matured technologically. Currently, effective circulatory support can be provided by implantable left ventricular assist devices (LVADs), which are portable, battery-powered units with a low risk of device-related thromboembolism [3–5]. The ultimate goal of these devices was never to be a temporary BTT, but rather to be a permanent therapy as an alternative to heart transplantation or medical therapy for patients who are not candidates for transplantation. In this report, we describe our initial experience using the implantable LVAD as permanent therapy for a patient who was not considered to be a transplant candidate.

A 67-year-old man was admitted to the Cleveland Clinic on November 29, 1995, because of progressive biventricular congestive heart failure, which began in 1993. He had undergone an initial coronary artery bypass with anterior left ventricular aneurysmectomy in 1983 and a second coronary bypass operation in 1988. His other medical problems included hypertension, hypercholesterolemia, and a 4.7-cm abdominal aortic aneurysm. Because of advanced age and the aortic aneurysm he was not considered a suitable heart transplant candidate. In the 5 months before admission, he had been hospitalized three times for congestive heart failure and treated with diuretics, afterload reduction, and inotropes. Echocardiograms and multigated angiograms performed in the month before admission had revealed a left ventricular ejection fraction of 0.19 with 3+ mitral and tricuspid regurgitation. His medications on admission were furosemide, 80 mg twice daily; spironolactone, 25 mg daily; digoxin, 0.25 mg daily; captopril, 25 mg three times per day; ranitidine, 150 mg twice daily; and alprazolam, 0.5 mg three times daily as necessary. His vital signs included a blood pressure of 86/70 mm Hg, respirations at 24/min, and a regular heart rate of 88 beats/min. He had 3+ edema to his knees, and 8-cm jugular venous distention. Cardiac examination was remarkable for cardiomegaly, frequent ectopy, and a grade 3/6 holosystolic apical murmur.

After diuresis, he underwent right heart catheterization on the second hospital day. The findings were consistent with severe congestive heart failure with a cardiac index of 0.97 L•min^-1•m^-2 and a pulmonary capillary wedge pressure of 38 mm Hg (Table 1). He was treated with an intravenous dobutamine infusion and transferred to the intensive care unit. Despite dobutamine at 10 µg•kg^-1•min^-1, his cardiac index remained approximately 1.7 to 2.4 L•min^-1•m^-2. On December 3, the serum sodium level was 131 mEq/L, the creatinine level was 1.1 mg/dL, and the total bilirubin level was 1.5 mg/dL.

After consultation with the LVAD manufacturer, ThermoCardiosystems, Inc (Woburn, MA), notification of protocol deviation to the United States Food and Drug Administration, and approval from the Cleveland Clinic's Institutional Review Board, the vented-electric HeartMate LVAD (Fig 1) was implanted using our typical preperitoneal insertion technique [5, 6] on December 5, 1995. The operation proceeded smoothly, the patient was extubated the night of the operation, and his hemodynamic status improved (see Table 1). He was transferred to a regular nursing floor the day after the operation. His hospitalization was remarkable for temporary atrial flutter and for drainage around the percutaneous LVAD drive line. He and his wife were trained in the proper care of the LVAD and were discharged to an outpatient facility 13 days after the operation.

View larger version (76K): [in this window] [in a new window]   Fig 1. . Blood flows from the left atrium through the left ventricle and pump inflow valved conduit into the left ventricular assist device (LVAD). The LVAD is implanted in the abdominal wall. Blood is pumped back into the ascending aorta. During typical LVAD function, the left ventricle is completely unloaded and the aortic valve does not open. (Reprinted with the permission of The Cleveland Clinic Foundation.)

	Comment

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Mechanical circulation technology has improved greatly in the decade after permanent mechanical circulatory support ended. We have learned that most patients with biventricular heart failure can be successfully supported with an LVAD [5]. The risk of device-related thromboemboli is low, despite minimal anticoagulation with antiplatelet agents [4]. We have seen only one device-related transient ischemic attack at the Cleveland Clinic after more than 4,400 patient-days of support in 80 HeartMate BTT patients. The battery-powered device is portable and simple, which allows patients to be mobile, to be discharged from the hospital, and to manage the day-to-day LVAD maintenance [3].

The evolution in LVAD technology occurred during the "clinical laboratory" phase of temporary use as a BTT. However, this use is a means to an end, not the end itself. Bridging to transplantation only rearranges which patients will survive to receive the limited number of donor hearts. The number of donated hearts is vastly inadequate to meet the estimated demand of potentially 70,000 patients per year who could receive mechanical support [8].

The improvements in technology and the overwhelming clinical need for such devices convinced us to return to the use of permanent mechanical support. We anticipate early permanent implantations will be performed in patients with end-stage heart failure who are not considered candidates for transplantation, usually because of age [6]. There are, however, still many unanswered questions regarding widespread permanent LVAD use, including the risk of infections, long-term device reliability and durability, and cost-effectiveness in relation to other therapies [9]. However, these issues are best addressed by permanent implants, not by temporary BTT implants. These questions will soon be investigated by a trial comparing permanent LVAD implants to patients receiving conventional medical therapy [6]. Our patient was unlikely to survive until that trial began, but provided a glimpse of the future for patients on permanent LVAD support.

	Addendum

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Approximately 6 months after LVAD insertion, progressive dyspnea developed until the patient returned to class III symptoms. Echocardiography disclosed new LVAD inflow valve insufficiency. There were no clinical signs of sepsis, the percutaneous drive line was healed by this time, and blood cultures showed no growth. An elective fourth operation to replace the defective valved conduit (and remaining device) was offered but the patient declined and wanted to consider the situation further.

On the evening of the 225th day of support, the LVAD suddenly had a total device failure and could not be pumped either electrically or with the back-up pneumatic actuation mode. The patient returned by helicopter to the Cleveland Clinic within 1 hour of LVAD failure but was in cardiogenic shock. Echocardiography confirmed no pumping of the LVAD. Despite inotropes the patient remained in cardiogenic shock. Emergency reoperation to replace the defective LVAD was offered. After discussion with his family, the patient courageously declined, well aware of the inevitable outcome. He said he had "had enough" and did not want a fourth operation. He was made comfortable and died hours later of heart failure, 226 days after LVAD insertion.

Autopsy confirmed extensive ischemic cardiomyopathy. One leaflet of the inflow valve had degenerated centrally; there were no vegetations and valve cultures showed no growth. The cause of the valve degeneration is unknown. A metal particle, caused by the motor contacting the motor housing, had worked its way into the diaphragm separating the blood pump from the motor. The diaphragm was perforated, allowing blood to enter the motor and cease actuation, either electrical or pneumatic. The defect allowing the motor to contact the housing was eventually traced to a correctable problem with the spacer washers. All electric HeartMate LVADs now have corrected spacer washers to avoid this problem.

This courageous patient indeed allowed us to glimpse the future. By the springtime he was comfortable with his LVAD and had a good quality of life, working outdoors in his garden, washing outside windows, and pushing a wheelbarrow, and generally he was content. However, we are still in the earliest, sometimes painful, development phase with these devices. He had been made well aware of the possibility of LVAD failure and accepted the outcome with an impressive fortitude. Until we reach the time when the devices are more durable (and unfortunately, we will have to learn from our mistakes), this drama will unfold again.

	Acknowledgments

Top Footnotes Abstract Introduction Comment Addendum Acknowledgments References

 
This work was supported in part by grants from George and Linda Kaufman and from Donald Wright.

	Footnotes

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Address reprint requests to Dr McCarthy, Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic Foundation, 9500 Euclid Ave, F-25, Cleveland, OH 44195 (e-mail: mccartp{at}cesmtp.ccf.org).

	References

Top Footnotes Abstract Introduction Comment Addendum Acknowledgments References

 

1. Marwick C. Pondering past, future of implantable heart. JAMA 1985;254:3288–92.[Abstract/Free Full Text]
2. Cole HM. Four years of replacing ailing hearts: surgeons assess data, questions remain. JAMA 1986;256:2921–30.[Abstract/Free Full Text]
3. Frazier OH. Chronic left ventricular support with a vented electric assist device. Ann Thorac Surg 1993;55:273–5.[Abstract/Free Full Text]
4. Rose EA, Levin HR, Oz MC, et al. Artificial circulatory support with textured interior surfaces. A counterintuitive approach to minimizing thromboembolism. Circulation 1994;90(Suppl 2):87–91.[Abstract/Free Full Text]
5. McCarthy PM, Savage RM, Fraser CD, et al. Hemodynamic and physiologic changes during support with an implantable left ventricular assist device. J Thorac Cardiovasc Surg 1995;109:409–18.[Abstract/Free Full Text]
6. McCarthy PM. HeartMate implantable left ventricular assist device: bridge to transplantation and future applications. Ann Thorac Surg 1995;59:S46–51.
7. Rogers L. Electric lifesaver. [Able Goodman's electric heart]. The Sunday Times. London. Oct 29, 1995;8931:1.17.
8. Hogness JR, Van Antwerp M, eds. The artificial heart: prototypes, policies, and patients. Washington, DC: National Academy Press 1991:4.1–4.18.
9. McCarthy PM. Permanent implantable LVADS: the hype, the truth, the FDA. J Heart Lung Transplant (in press).

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This Article Abstract 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): Patrick M. McCarthy James B. Young Nicholas G. Smedira Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by McCarthy, P. M. Articles by Starling, R. C. Search for Related Content PubMed PubMed Citation Articles by McCarthy, P. M. Articles by Starling, R. C.