Correspondence
Left Ventricular Assist Device
N Engl J Med 2002; 346:1023-1025March 28, 2002
- Article
To the Editor:
Rose et al. (Nov. 15 issue)1 performed a seminal trial of the use of a left ventricular assist device for end-stage heart failure. However, to gauge the full extent of the effect of invasive therapy with a left ventricular assist device on the health-related quality of life, missing data must be accounted for (i.e., subjects who died between administrations of the questionnaires measuring health-related quality of life or who are alive but did not participate in serial evaluations).2 For example, among other statistical techniques, the investigators could assign the “worst possible score” to those who died or, even though it may be difficult, impute a score on the basis of correlations between prior responses and clinical status. Furthermore, the way in which the health-related quality of life is measured should be delineated, since the method and timing of the administration of questionnaires may affect the results.3 Since mortality remains high in the group with the left ventricular assist device (77 percent at two years), the argument for the use of mechanical therapy may very well rest on its effect on the health-related quality of life.
3 ReferencesPaul J. Hauptman, M.D.
Saint Louis University, St. Louis, MO 631101
Rose EA ,Gelijns AC ,Moskowitz AJ , et al. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med 2001;345:1435-1443
Full Text | Web of Science | Medline2
Al-Kaade S ,Hauptman PJ . Health-related quality of life measurement in heart failure: challenges for the new millennium. J Card Fail 2001;7:194-201
CrossRef | Web of Science | Medline3
Gill TM ,Feinstein AR . A critical appraisal of the quality of quality-of-life measurements. JAMA 1994;272:619-626
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To the Editor:
The value of angiotensin-converting–enzyme (ACE) inhibitors, beta-blockers, and spironolactone has been well established by the results of numerous clinical trials. About 70 percent of the patients described by Rose et al. were treated with ACE inhibitors or angiotensin II–receptor antagonists; 35 to 40 percent received spironolactone, and only about 20 percent received beta-blockers. Thus, this population cannot have been considered to be optimally treated from the point of view of medical therapy.
Manuel Jiménez-Navarro, M.D.
Encarnación Molero, M.D.
Eduardo de Teresa, M.D.
Hospital Clínico Universitario Virgen de la Victoria, 29007 Málaga, Spain
manolola@hotmail.com To the Editor:
In the study by Rose et al., the use of a left ventricular assist device in patients with advanced heart failure resulted in a survival benefit and an improved quality of life. It is noteworthy that the most frequent cause of death among patients in the group with the left ventricular assist device was sepsis. Although the characteristics of these infections are not described, data1,2 from the use of a left ventricular assist device as a bridge to transplantation suggest that the incidence and severity of infections in patients receiving support with these devices are proportional to the duration of mechanical circulatory support.
More recently, our report3 of infections in patients with extended support with left ventricular assist devices demonstrates an emerging spectrum of serious infections. The repeated bacteremic episodes in these patients, despite long courses of antibiotics, are suggestive of persistent endovascular infection resembling endocarditis. In addition, the relapsing bacteremia may have arisen from the drive lines of the left ventricular assist devices. The possible contribution of drive-line infections to the development of relapsing bacteremia and endocarditis associated with left ventricular assist devices in the course of extended circulatory support cannot be underestimated. Both conditions are difficult to eradicate with antibiotics and may require a change of the device, increasing morbidity and mortality among these patients. Perhaps the recent development of drive lines impregnated with antimicrobial agents may prevent the colonization of the drive lines and facilitate ingrowth of tissue to provide long-term stability and protection for patients receiving extended circulatory support with left ventricular assist devices.4
4 ReferencesRegis A. Vilchez, M.D.
Robert Kormos, M.D.
Shimon Kusne, M.D.
University of Pittsburgh Medical Center, Pittsburgh, PA 15213
kusnes2@msx.upmc. edu 1
Griffith BP ,Kormos RL ,Nastala CJ ,Winowich S ,Pristas JM . Results of extended bridge to transplantation: window into the future of permanent ventricular assist devices. Ann Thorac Surg 1996;61:396-398
CrossRef | Web of Science | Medline2
Pennington DG ,Griffith BP ,McKinlay SM , et al. Evaluation of an implantable ventricular assist system for humans with chronic refractory heart failure: study overview. ASAIO J 1995;41:11-15
CrossRef | Medline3
Vilchez RA ,McEllistrem MC ,Harrison LH ,McCurry KR ,Kormos RL ,Kusne S . Relapsing bacteremia in patients with ventricular assist device: an emergent complication of extended circulatory support. Ann Thorac Surg 2001;72:96-101
CrossRef | Web of Science | Medline4
Choi L ,Choudhri AF ,Pillarisetty VG , et al. Development of an infection-resistant LVAD driveline: a novel approach to the prevention of device-related infections. J Heart Lung Transplant 1999;18:1103-1110
CrossRef | Web of Science | Medline
To the Editor:
The randomized study by Rose and colleagues demonstrated that a left ventricular assist device improves survival and quality of life in adults with advanced heart failure. The authors do not mention the use of assist devices in children.
We successfully implanted miniaturized pulsatile devices with stroke volumes of 10 to 60 ml (Berlin Heart, Berlin, Germany) in 45 infants and children from 1990 through 20011,2 and are impressed by the results in patients with myocarditis or cardiomyopathy (Table 1Table 1
Characteristics of Children with Myocarditis or Cardiomyopathy Who Received Pneumatic Pulsatile Ventricular Assist Devices.). All children presented with cardiogenic shock and multiorgan failure after repeated resuscitation, and death was expected within hours. Of the 28 children, 6 received a left ventricular assist device and 22 a biventricular assist device. Although the majority of the children with myocarditis were weaned from ventricular support after recovery of their own heart, in most children with cardiomyopathy such support was used as a bridge to transplantation.Children often die before transplantation because of the shortage of organs, and frequently no recipient of appropriate size is found when a child's heart becomes available. We expect that children with end-stage heart failure will benefit from mechanical cardiac support and that fewer organs from young donors will be lost.
2 ReferencesBrigitte Stiller, M.D.
Peter E. Lange, M.D., Ph.D.
Roland Hetzer, M.D., Ph.D.
Deutsches Herzzentrum Berlin, 13353 Berlin, Germany
stiller@dhzb.de 1
Stiller B ,Dahnert I ,Weng YG ,Hennig E ,Hetzer R ,Lange PE . Children may survive severe myocarditis with prolonged use of biventricular assist devices. Heart 1999;82:237-240
Web of Science | Medline2
Hetzer R ,Loebe M ,Potapov EV , et al. Circulatory support with pneumatic paracorporeal ventricular assist device in infants and children. Ann Thorac Surg 1998;66:1498-1506
CrossRef | Web of Science | Medline
Author/Editor Response
The authors reply:
To the Editor: We agree with Hauptman's contention that issues of health-related quality of life are crucial to “the argument for the use of mechanical therapy” for patients with end-stage heart failure. We disagree, however, with his suggestion of assigning a “worst possible score” to those who died, because we believe that the health-related quality of life of a person who has died is not some low number; it is undefined. On the other hand, imputing a low score to truly missing observations from survivors seems sensible, because missing data often connote a poor health-related quality of life. Applying this strategy to the data from the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial (Table 3 in our article) would accentuate the advantage of left ventricular assist devices, because the fraction of observations missing is larger in the group receiving optimal medical management. Our report did not enumerate all the details of our methods and measurement schedule for assessing the health-related quality of life, which we have described elsewhere.1
Jiménez-Navarro and colleagues argue that the low frequency of use of beta-blockers, ACE inhibitors, and spironolactone at base line in the medically treated group of the REMATCH trial reflects suboptimal medical therapy, because recent trials reported a survival benefit from these agents in patients with “severe heart failure.”2-4 As Braunwald pointed out, however, the Carvedilol Prospective Randomized Cumulative Survival trial (of beta-blockers) excluded patients with “extremely severe heart failure” — the target population for the REMATCH trial.2,5 Similarly, the Randomized Aldactone Evaluation trial (of spironolactone) and the Cooperative North Scandinavian Enalapril Survival Study (of ACE inhibitors) also focused on less severely ill patients than those we studied. In the REMATCH trial, dependency on inotropic therapy was 70 percent at base line, and patients who were not dependent at base line had markedly reduced oxygen consumption (average peak consumption, 9.18±1.98 ml per kilogram of body weight per minute). Few of these patients were subsequently able to tolerate ACE inhibitors, let alone beta-blockers or spironolactone.
Vilchez et al. correctly point out the “emerging spectrum of serious infections” to which patients with left ventricular assist devices are susceptible. We agree that persistent bacteremia may necessitate removal or replacement of the device, whereas the use of drive lines impregnated with antibiotics or the use of fully implantable devices may reduce the incidence of this dreaded complication.
Stiller et al. describe excellent results from the short-term use of assist devices in children as a bridge to transplantation or to recovery from acute myocarditis. Although neither their experience nor the REMATCH trial addresses the long-term use of devices in children, this critical area deserves future investigation.
5 ReferencesEric A. Rose, M.D.
Deborah D. Ascheim, M.D.
Peter A. Shapiro, M.D.
Columbia University, New York, NY 100321
Rose EA ,Moskowitz AJ ,Packer M , et al. The REMATCH trial: rationale, design, and end points: Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure. Ann Thorac Surg 1999;67:723-730
CrossRef | Web of Science | Medline2
Packer M ,Coats AJS ,Fowler MB , et al. Effect of carvedilol on survival in severe chronic heart failure. N Engl J Med 2001;344:1651-1658
Full Text | Web of Science | Medline3
The CONSENSUS Trial Study Group
Full Text | Web of Science | Medline4
Pitt B ,Zannad F ,Remme WJ , et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. N Engl J Med 1999;341:709-717
Full Text | Web of Science | Medline5
Braunwald E . Expanding indications for beta-blockers in heart failure. N Engl J Med 2001;344:1711-1712
Full Text | Web of Science | Medline
- Citing Articles (1)
Citing Articles
1
Virginia Fidrocki Mason, Annette Jakubisin Konicki. (2003) Left Ventricular Assist Devices as Destination Therapy. AACN Clinical Issues: Advanced Practice in Acute and Critical Care 14:4, 488-497
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