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JACC: HEART FAILURE VOL. 4, NO. 3, 2016 ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER ISSN 2213-1779/$36.00 http://dx.doi.org/10.1016/j.jchf.2015.12.012 EDITORIAL COMMENT A Machine Without an Owner’s Manual* Joseph G. Rogers, MD,a,b Adam D. DeVore, MDa,b C ontemporary growth in the use of left ven- select a single constant speed, ignoring the obvious tricular assist devices (LVADs) to support pa- changes in physiological demand that occur during tients is daily life. Most providers determine optimal speed remarkable. In the United States alone, more than using echocardiographic guidance with the patient 2,400 LVADs were implanted in adults in 2014 recumbent and at rest, selecting a speed that mini- compared with 459 in 2008 (1). Although periopera- mizes patient symptoms without excessively unload- tive survival is comparable to that for routine cardiac ing the left ventricle. Alternatively, a ramp study may with advanced heart failure surgical procedures, 50% of LVAD patients have died be utilized in which final settings are determined by within 4 years of implantation (1). Long-term man- careful study of the impact of graduated increases in agement of LVAD patients remains enigmatic and device speed on patient symptoms, vital signs, ven- program specific, lacks a robust evidence base, and tricular geometry, and valve function (4). could reasonably be postulated to contribute importantly to the observed morbidity and mortality. The SEE PAGE 208 most recent guideline on outpatient LVAD manage- In this issue of JACC: Heart Failure, Uriel et al. (5) ment cites only 3 of 69 (4.3%) recommendations as extend their previous work on the noninvasive ramp being Level of Evidence A (2) compared with 22% study and describe an approach to determining high-level recommendations in the most recent optimal LVAD speed by integrating hemodynamic American College of Cardiology/American Heart As- and echocardiographic parameters. The authors per- sociation heart failure guideline (3). Questions per- formed ramp studies with simultaneous right-sided taining to common clinical conundrums such as the heart catheterization and echocardiography in 35 most appropriate dose of antiplatelet agents, the stable outpatients thought to be well supported on best strategy for the management of right-sided heart their LVAD based on their reported medical history, failure, and the optimal treatment for refractory physical examination, and laboratory test results mucosal bleeding remain eminence based. There is (Figure 1). The goal was to define the LVAD speed an urgent need to develop evidence that guides associated with the most desirable hemodynamic patient and device management for normal LVAD and echocardiographic parameters: central venous physiology and complications for this increasingly pressure <12 mm Hg, pulmonary capillary wedge common and expensive medical intervention. pressure <18 mm Hg, intermittent aortic valve LVAD speed is the one parameter that can be opening, and minimized mitral regurgitation. adjusted to change the level of support provided by There was a striking discordance between clinical contemporary LVADs. Current technology for the 2 assessment of optimal hemodynamics and those found commercially available devices allows providers to in the laboratory, with fewer than 50% of this cohort meeting the hemodynamic goals at baseline. After *Editorials published in JACC: Heart Failure reflect the views of the au- guided speed adjustment, the proportion of patients thors and do not necessarily represent the views of JACC: Heart Failure or with desirable hemodynamic profiles increased from the American College of Cardiology. 43% to 56%, with nearly one-third of the patients From the aDepartment of Medicine, Duke University School of Medicine, requiring an important speed change as a result of the Durham, North Carolina; and the bDuke Clinical Research Institute, Duke ramp test. An increase in LVAD speed resulted in University School of Medicine, Durham, North Carolina. Dr. DeVore has patient-specific increases in cardiac output and re- received research funding from Amgen, the American Heart Association, Maquet, Novartis, and Thoratec. Dr. Rogers has reported that he has no ductions in pulmonary capillary wedge pressure relationships relevant to the contents of this paper to disclose. without an acute change in the central venous pressure. Rogers and DeVore JACC: HEART FAILURE VOL. 4, NO. 3, 2016 MARCH 2016:218–9 A Machine Without an Owner’s Manual Although this study provides important new knowledge that may allow better patient and device F I G U R E 1 Protocol Summary management, important limitations must be acknowledged, the most obvious being the lack of clear linkage between speed optimization and outcomes. There are almost no clinical trial data that confirm a clear relationship between hemodynamics and outcomes in non–device-treated heart failure patients, which raises the possibility that this approach may not favorably impact symptoms, functional capacity, quality of life, or LVAD-related morbidity. In addition, broad application of invasive ramp studies in LVAD patients has inherent risk that must be weighed against the value of the information provided. The ventricular assist device community needs to be certain that there is tangible patient benefit beyond a modest hemodynamic benefit and more photogenic hearts. Finally, the durability of these hemodynamic changes and the potential that ramp testing should be repeated with some frequency must be addressed. Summary of the combined hemodynamic and echocardiographic ramp test protocol. Patients with either a Heart Mate II (HMII)( Thoratec, Pleasanton, California) or HeartWare ventricular device (HVAD) (HeartWare International, Framingham, Massachusetts) were included in the study (*). CVP ¼ central venous pressure; echo ¼ echocardiography; INR ¼ international normalized ratio; LVAD ¼ left ventricular assist device; LVEDD ¼ left ventricular end-diastolic The number of patients in the United States eligible for advanced heart failure therapies is estimated to be dimension; max ¼ maximum; PCWP ¼ pulmonary capillary wedge pressure; PTT ¼ partial thromboplastin time. between 250,000 and 300,000 (6), and the number of patients living in the community with LVAD support proper design, INTERMACS could be used as the data continues to grow. The establishment of an evidence repository and analytical center for such a network base for the long-term management of patients with and would promote synergies and broad application LVADs is essential. We continue to operate in silos of of successful interventions. care that rely heavily on INTERMACS (Interagency This past weekend, many of us may have worked Registry for Mechanically Assisted Circulatory Sup- diligently to assemble a piece of furniture, repair a car port) (7) to describe trends in LVAD use; however, engine, or fix a computer glitch. Few would attempt INTERMACS may not be well suited for much of the such a feat without detailed instruction, sage counsel, heavy lifting required to improve VAD outcomes. proper tools, and an instruction manual. These tools, Creation of an LVAD research network structured based on experience and experimentation, ensure similarly to the National Institutes of Health–funded success for “do-it-yourselfers.” We should not have a Heart Failure Research Network and the Cardiac lower expectation for medical devices. Surgery Network would facilitate the development of foundational knowledge. These networks consist REPRINT REQUESTS AND CORRESPONDENCE: Dr. of high-volume centers committed to clinical trials Adam D. DeVore, Duke Clinical Research Institute, 2400 with a well-defined infrastructure that allows rapid Pratt Street, NP-7047B, Durham, North Carolina 27705. implementation and execution of small studies. With E-mail: [email protected]. REFERENCES 1. Kirklin JK, Naftel DC, Pagani FD, et al. Seventh INTERMACS annual report: 15,000 patients and counting. J Heart Lung Transplant 2015; 34:1495–504. Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2013;62:e147–239. 6. Miller LW. Left ventricular assist devices are underutilized. Circulation 2011;123:1552–8, discussion 1558. 2. Feldman D, Pamboukian SV, Teuteberg JJ, et al. The 2013 International Society for Heart and Lung Transplantation guidelines for mechanical circulatory support: executive summary. J Heart Lung Transplant 2013;32:121–46. 4. Uriel N, Morrison KA, Garan AR, et al. Development of a novel echocardiography ramp test for speed optimization and diagnosis of device 7. Interagency Registry for Mechanically Assisted Circulatory Support. INTERMACS website. Available at: https://www.uab.edu/medicine/intermacs/. thrombosis in continuous-flow left ventricular assist devices: the Columbia ramp study. J Am Coll Cardiol 2012;60:1764–75. Accessed November 10, 2015. 3. Yancy CW, Jessup M, Boskurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of 5. Uriel N, Sayer G, Addetia K, et al. Hemodynamic ramp tests in patients with left ventricular assist devices. J Am Coll Cardiol HF 2016;4:208–17. KEY WORDS advanced heart failure, left ventricular assist devices, mechanical circulatory support 219