864 Stewart et al. The Journal of Heart and Lung Transplantation September 2009 ventricular ejection fraction (LVEF) 35% and symptomatic heart failure

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1 FEATURED ARTICLES Thresholds of Physical Activity and Life Expectancy for Patients Considering Destination Ventricular Assist Devices Garrick C. Stewart, MD, a Kimberly Brooks, RN, a Parakash P. Pratibhu, MPH, MBA, a Sui W. Tsang, MPH, MBA, b Marc J. Semigran, MD, c Colleen M. Smith, AP, RN, a Catherine Saniuk, RN, MS, CCRN, a Janice M. Camuso, RN, c James C. Fang, MD, d Gilbert H. Mudge, MD, a Gregory S. Couper, MD, a Kenneth L. Baughman, MD, a and Lynne W. Stevenson, MD a Background: Methods: Results: Conclusions: Current implantable left ventricular assist devices (LVAD) improve survival and function for patients with very late stage heart failure (HF) but may also offer benefit before inotrope dependence. Debate continues about selection of HF patients for LVAD therapy. We sought to determine what level of personal risk and disability HF patients thought would warrant LVAD therapy. The study included 105 patients with symptomatic HF and an LV ejection fraction (EF) 35% who were given a written paragraph about LVADs and asked about circumstances under which they would consider such a device. New York Heart Association (NYHA) functional class, time trade-off utility, and patient-assessed functional score were determined. Participants (mean age, 58 years) had an LVEF of 21%. The median duration of HF was 5 years, and 65% had a primary prevention implantable cardioverter defibrillator. Presented with a scenario of bed-ridden HF, 81% stated they would definitely or probably want an LVAD; 50% would consider LVAD to prolong survival if HF survival were predicted to be 1 year and 75% if 6 months. Meanwhile, 44% would consider LVAD if they could only walk 1 block and 64% if they could not dress without stopping. Anticipated thresholds did not differ by NYHA class, time trade-off, or functional score. Patient thresholds for LVAD insertion parallel objective survival and functional data. HF patients would be receptive to referral for discussion of LVAD by the time expected mortality is within 6 to 12 months and activity remains limited to less than 1 block. J Heart Lung Transplant 2009;28: Copyright 2009 by the International Society for Heart and Lung Transplantation. From the a Divisions of Cardiovascular Medicine, Brigham and Women s Hospital and c Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; the b Department of Biostatistics, School of Epidemiology and Public Health, Yale University, New Haven, Connecticut; and the d Division of Cardiology, University Hospitals, Case Western Reserve University, Cleveland, Ohio. Submitted February 9, 2009; revised May 9, 2009; accepted May 9, Reprint requests: Garrick C. Stewart, MD, Division of Cardiovascular Medicine, Brigham and Women s Hospital, 75 Francis St, Boston, MA Telephone: Fax: gcstewart@partners.org Copyright 2009 by the International Society for Heart and Lung Transplantation /09/$ see front matter. doi: / j.healun Implantable left ventricular assist devices (LVAD) have been shown to improve survival and function in patients with very late stage heart failure. 1,2 LVAD use has expanded from a bridge for patients with refractory heart failure awaiting heart transplant to a permanent alternative to transplantation, known as destination therapy. LVAD therapy has the potential to meet the growing demand of patients with advanced heart failure who are confronting a severe shortage of donor hearts. 3 Despite promising results from the landmark Randomized Evaluation of Mechanical Assistance in Treatment of Chronic Heart Failure (REMATCH) trial showing that LVAD-treated patients had a 30% absolute mortality reduction at 1 year, destination LVAD therapy has not been widely adopted. 4 Improved device durability and candidate risk stratification will lead to expanding indications for LVAD. 5 7 As debate continues about appropriate patient selection criteria for LVAD therapy, we wanted to determine the threshold of interest in LVADs among heart failure patients. We presented patients with a scenario of end-stage heart failure to identify their thresholds for considering LVAD therapy based on functional limitation and life expectancy. Understanding when patients would seek LVAD therapy will help guide appropriate referral strategies for refractory heart failure. METHODS Study Population Adult volunteers were enrolled from 2 heart failure referral centers in Boston, Massachusetts, between February 2005 and January 2006 after protocol approval by the Institutional Review Boards. Participants were both inpatients and outpatients. Inclusion criteria were left 863

2 864 Stewart et al. The Journal of Heart and Lung Transplantation September 2009 ventricular ejection fraction (LVEF) 35% and symptomatic heart failure. Excluded were patients with a history of ventricular tachycardia, ventricular fibrillation, cardiac arrest, or syncope. These criteria were constructed to accommodate a portion of the device survey involving primary prevention implantable cardioverter defibrillator (ICD) therapy. Participants were not required to be candidates for cardiac transplantation or mechanical circulatory support to participate in the survey. Baseline clinical data from within 3 months before study enrollment were compiled by review of the electronic medical record. These data included ejection fraction, duration and etiology of heart failure, peak oxygen consumption with exercise (VO 2 max) and New York Heart Association (NYHA) functional class as determined by a cardiologist. Routine serum markers of cardiac and renal function were assessed, including measurements of serum sodium, serum creatinine, blood urea nitrogen, and B-type natriuretic peptide. Survey Instrument After providing informed consent, patients completed a written survey about destination LVAD therapy (Appendix). At the beginning of the survey, patients read the following statement about LVADs: Left ventricular assist devices are currently available that can be put in to support the heart when heart failure becomes very severe and the heart is too weak to pump enough blood to the body. This requires a major cardiac surgery and the device is put into your left upper abdomen. Hospital recovery is generally about 4 weeks before patients return home. There are currently several investigational devices and one approved device for this purpose. Patients were also told about newer, lower-profile devices (axial flow pumps) that are smaller and less audible. This questionnaire was submitted to patients when non-pulsatile LVADs were investigational and no survival data were available. Patients were told that such non-pulsatile devices were not yet approved and had unknown rates of mechanical failure and stroke. Participants were then asked about their device preference (axial flow or pulsatile). All questionnaire items were multiple-choice and some allowed multiple responses. The survey instrument could be completed at the clinical encounter or at home and then returned by mail. Patients were asked to assign themselves a functional score using a visual analog scale, with 0 being the worst and 100 the best global assessment of functional. At study enrollment, a heart failure nurse also interviewed each patient and administered a time trade-off questionnaire. Time trade-off is a utility to assess patient preferences about quality of life vs length of survival. Respondents iteratively chose between different set amounts of life in a compromised health state (heart failure) and a shorter time in perfect health. This survey used a time horizon of 2 years. Time trade-off is reported as the ratio of the shorter life expectancy in perfect health divided by 2 years in their current state of heart failure. This yields a utility from 0 to 1, with 1 representing patients not wishing to trade away any time in their current state of health. Statistical Analysis Responses to the questionnaire are reported as the percentage of participants who answered each item. Survey responses were stratified by ICD presence or absence, inpatient vs outpatient status, NYHA functional class, and time trade-off. For purposes of analysis, the mean time trade-off score was used, along with strata based on trading off 3 months or less ( 0.875), 6 months or less ( 0.75) or less than 12 months ( 0.5), from a maximum of 24 months. Item responses between these different groups were compared using Fisher s exact test for differences in proportions. The data and statistical analysis was performed using SAS 9.1 software (SAS Institute, Cary, NC). RESULTS Baseline Characteristics Baseline clinical characteristics are reported in Table 1. The 105 patients who took the survey were a mean age of 58 years, 70% were male, mean LVEF was 21%, 52% Table 1. Baseline Clinical Characteristics Mean (SD) or % Variable (N 105) Age, years 58 (13) Male 70 NYHA class I 18 II 41 III 36 IV 3 Duration 5 years 52 Ischemic etiology 34 ICD for primary prevention 65 LVEF, % 21 (7) Peak VO 2 max, ml/kg/min 14.8 (4.6) Serum sodium, meq/liter 139 (3) Blood urea nitrogen, mg/dl 34 (21) Serum creatinine, mg/dl 1.6 (1.0) Functional score (0 100) 61 (22) B-type natriuretic peptide, pg/ml 809 (1,286) Time trade-off utility, (0.32) ICD, implantable cardioverter defibrillator; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; SD, standard deviation; VO 2 max, peak oxygen consumption with exercise.

3 The Journal of Heart and Lung Transplantation Stewart et al. 865 Volume 28, Number 9 had heart failure longer than 5 years, 40% were NYHA functional class III or IV, and 35% had an ischemic etiology. Mean peak oxygen consumption at cardiopulmonary testing was 14.8 ml/kg/min. Few survey participants had NYHA class IV symptoms because the survey group was initially formulated to focus on ambulatory patients. In all, 65% of patients surveyed already had undergone ICD placement for primary prevention of sudden death. The mean patient-assessed functional score was 61/100 and the time trade-off utility was Interest in VADs Participants were asked about their general interest in an LVAD after being presented with a scenario of advanced heart disease: Suppose that your heart failure were so bad that nothing else could be done for you. If you could not get out of bed and were told that you would be dead soon, would you consider a left ventricular assist device put in that would allow you to move around comfortably and live longer? Figure 1. When presented with a scenario of end-stage heart failure, participants were asked: Which statement describes how you would feel about having an assist device in this situation? Figure 2. Heart failure patients surveyed were asked: Which information about the assist device would be most important to your decision about whether to have one how long you would survive with it and/or how your quality of life would be? Most heart failure patients would be willing to consider LVAD when presented with such a scenario (Figure 1). There were no significant differences in responses based on inpatient or outpatient status, NYHA functional class, length of time since first being diagnosed with heart failure, etiology of heart failure, or time trade-off utility. However, patients with a primary prevention ICD in place were more likely to be interested in an LVAD (p 0.03). More than 87% of ICD recipients described definitely or probably wanting an LVAD to relieve symptoms and prolong life in end-stage heart failure, compared with 65% of participants without an ICD. The most common reason cited for not wanting to consider an LVAD was fear of major surgery. Patients were then asked which LVAD feature would be a priority: improvement in functional capacity or prolongation of life (Figure 2). Most heart failure patients (63%) believed the effect of survival and quality of life would be equally important. Of the remainder, more patients were concerned about quality of life (25%) than survival (12%). When it came to weighing these 2 LVAD features, priorities were no different when stratified by NYHA class, etiology of heart failure, patient-assessed functional score, or time tradeoff utility. Among ICD recipients surveyed, there was a trend to be more concerned with improved survival than quality of life (p 0.065) when it came to consideration of LVAD. Inpatients surveyed tended to be more concerned about LVAD potential for improving quality of life compared with outpatients, but this did not reach statistical significance (p 0.054). Thresholds for LVAD Therapy Patients were then asked to imagine that their physician could tell them with certainty that they would have a given life expectancy. With this in mind, 91% would consider an LVAD if their life expectancy were less than 1 month, 69% if less than 6 months, 48% if less than 1 year, and 30% if less than 2 years (Figure 3). No significant differences in LVAD thresholds by life expectancy were noted when stratified by NYHA class, time trade-off, or duration of heart failure. However, individuals with nonischemic cardiomyopathy anticipated waiting until their life expectancy was much less

4 866 Stewart et al. The Journal of Heart and Lung Transplantation September 2009 Choosing Between Pulsatile and Non-pulsatile Devices When presented with a generic description of pulsatile and non-pulsatile LVADs, 61% of patients would favor the non-pulsatile devices for mechanical support vs 8%, with 29% expressing no preference. Enthusiasm for the newer non-pulsatile LVAD technology was no different when stratified by NYHA class, inpatient or outpatient status, or the presence of an ICD. Figure 3. Study participants were asked: Would you consider an assist device in order to prolong your survival if our life expectancy were less than? LVAD, left ventricular assist device. compared with those with heart failure of ischemic etiology (p 0.018). More than 40% of nonischemic individuals anticipated waiting until their life expectancy was less than 1 month before considering LVAD therapy. Given the well-recognized difficulty of accurately predicting survival in heart failure, survey recipients were asked to estimate their own life expectancy. Of those surveyed, 65% thought they would live more than 10 years, and 34% believed they would be alive for at least 20 years. Inpatients had a similar estimate of their survival as outpatients (p 0.78), although individuals in NYHA class III and IV thought they would have a shorter life expectancy than those in NYHA class I and II (p 0.01). The threshold for considering LVAD was no different between patients who anticipated living less than or more than a decade from the time of the survey. Study participants were given different levels of functional limitation and asked if they would consider an LVAD to improve their status (Figure 4). Only 7% would consider an LVAD if their worst limitation was requiring a wheelchair at the airport, 22% if they could not walk 5 blocks, and 44% if they were limited to walking less than 1 block without stopping. Meanwhile, 64% would consider LVAD if they could not get dressed without stopping and 96% if they could not get out of bed. Overall, as the functional limitation presented became more severe, a higher percentage of study participants would consider an LVAD to improve their quality of life. These preferences were no different between inpatients and outpatients, those with or without an ICD, etiology or duration of heart failure symptoms, NYHA class I and II vs III and IV, patient-assessed functional score, or time trade-off utility. DISCUSSION Most heart failure patients would consider destination LVAD therapy when presented with a scenario of end-stage heart failure. Heart failure patients can identify thresholds for destination LVAD therapy. Heart failure patients place equal emphasis on quality of life and improved survival. When faced with a choice between a pulsatile and non-pulsatile device, most patients expressed enthusiasm for the lower-profile, newer generation LVADs despite a lack of comprehensive data at that time. In patients without a contraindication, referral for discussion of LVAD therapy would be appropriate when function is limiting to walking less than 1 block or life expectancy is anticipated to be less than 1 year. These patient preferences parallel objective survival and functional data for heart failure patients expected to benefit from destination LVAD therapy. Timing of Referral for LVAD The era of destination therapy began with the publication of results from the REMATCH trial. Entry criteria for REMATCH included NYHA class III or IV heart failure with stage C or D symptoms and significant functional limitation despite maximally tolerated doses of drug therapy. 1 This is similar to the degree of illness in the scenario presented to survey participants in this study. Disease severity in patients actually enrolled in REMATCH was significantly worse than anticipated from the entry criteria, however, with more than 70% receiving continuous intravenous inotropes. 8 The de- Figure 4. Participants were asked: Would you consider an assist device in order to be more active if your most severe limitation were? LVAD, left ventricular assist device.

5 The Journal of Heart and Lung Transplantation Stewart et al. 867 Volume 28, Number 9 gree of illness among patients enrolled in LVAD trials along with concerns about device-related morbidity and durability have led to the perception that mechanical support should be limited to those most severely impaired Now, nearly 80% of durable LVADs are implanted in patients with cardiogenic shock and progressive decline despite inotropic therapy, even recognizing that the risks of implantation increase with advanced symptoms and dependence on inotropes. 1,12 Heart failure patients have been previously shown to express meaningful preferences for quality of life or length of survival, and in this survey they identified their own thresholds for considering LVAD. 13,14 There was a greater interest in assist devices among those surveyed with an ICD. Those willing to undergo ICD implantation may already be more open to the concept of implantable devices or the ICD experience increased their comfort with further technology. When presented with greater degrees of functional limitation, a larger proportion of patients expressed interest in mechanical circulatory assistance. Most patients surveyed would wish to consider having an LVAD if they were no longer able to walk a single block. Most LVADs (79%) are still implanted in patients with pre-implant Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) levels 1 and 2 when in critical cardiogenic shock or progressively declining NYHA class IV. 12 In this survey, patients would be willing to consider LVAD when housebound (INTERMACS level 5), a level at which VADs are already approved since VO 2 max is less than 12 ml/kg/min and often less then 10 ml/kg/min when patients can only walk 1 block. These results also reemphasize the importance of simple questions about activity limitation as part of the routine evaluation of chronic heart failure patients. Persistent symptoms at rest or severe limitation of daily activities may be a used as a simple trigger to refer patients for advanced therapies, including mechanical circulatory assistance. Another reason to consider referral for mechanical assistance would be impending death from heart failure. Most heart failure patients surveyed would consider LVAD if they were told their life expectancy would be less than 1 year. Predicting the time of death from heart failure has been notoriously difficult, however. Heart failure patients themselves often overestimate their own life expectancy, and in this study, 65% estimated at least 10 years of survival and 34% more than 20 years A pitfall in delaying referral for destination therapy until a patient is moribund with heart failure is the poor outcome typically seen when patients in cardiogenic shock undergo VAD implantation. This highlights the importance of risk stratification before LVAD implantation. 4,21,22 Yet, no single risk factor can independently predict survival and reliably differentiate between risk strata in patients with stage D heart failure, who may have a 1-year mortality risk from 15% to 20% up to 80%. 1,23,24 The development of a simple risk score to identify those with advanced heart failure who would benefit from LVAD must be a priority. 12 As mechanical circulatory assistance technology improves, the timing of destination therapy will shift to earlier stages of heart failure. 3,25 In turn, patient thresholds for device-based therapies will shift downward. The emerging HeartMate II (Thoratec, Pleasanton, CA) experience using a lower-profile, axial-flow pump illustrates the changing landscape of mechanical circulatory assistance technology. 26 When given the choice, most patients would select the lower-profile, axial-flow devices even though the evidence base for such devices is smaller, illustrating the challenge of doing randomized trials with disparate devices. Patient priorities in LVAD design appear to be driven by potential mortality benefit and functional improvement, along with fear of stroke. There must be an ongoing engagement of heart failure patient preferences for advanced therapies to inform the timing of LVAD referral and the selection of end points in future LVAD clinical trials. Limitations Survey participants may reflect referral bias to tertiary care, thereby enriching this sample with patients more interested in more aggressive therapies such as LVAD or heart transplantation. The scenarios of advanced heart failure and LVAD therapy that patients were asked to consider are hypothetical. Participants with the most advanced heart failure, including NYHA class IV symptoms, were under-represented in the survey, with only 3 patients experiencing symptoms at rest at the time of the survey. Most participants were asked to imagine symptoms they had never experienced. Decision making about invasive therapies may be quite different when faced with heart failure reaching the end stage. Future Directions More information is becoming available to clinicians and patients about mechanical circulatory assistance from INTERMACS. 27 This collaborative effort between the National Institutes of Health, Food and Drug Administration (FDA), Center for Medicare and Medicaid Services, the University of Alabama, and the United Network of Organ Sharing has so far enrolled more than 1,300 patients with 10 different FDA-approved mechanical circulatory assist devices from more than 90 clinical sites. 12 The registry will bridge the gap between clinical trial experience and the rapidly evolving real-world use of mechanical circulatory assistance. In the process, INTERMACS will help refine selection criteria for VAD therapy, inform best practice guidelines, and allow

6 868 Stewart et al. The Journal of Heart and Lung Transplantation September 2009 clinicians to provide patients more information about device comfort, quality of life, and survival after implantation. 28,29 The challenge in advanced heart failure will be to align clinical practice with what patients seek from mechanical circulatory assist devices and what current technology delivers. DISCLOSURE STATEMENT The authors report no conflicts of interest related to this project. REFERENCES 1. Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med 2001;345: Rogers JG, Butler J, Lansman SL, et al. Chronic mechanical circulatory support for inotrope-dependent heart failure patients who are not transplant candidates: results of the INTrEPID Trial. J Am Coll Cardiol 2007;50: Lietz K, Miller LW. Will left-ventricular assist device therapy replace heart transplantation in the foreseeable future? Current opinion in cardiology 2005;20: Lietz K, Long JW, Kfoury AG, et al. Outcomes of left ventricular assist device implantation as destination therapy in the post- REMATCH era: implications for patient selection. Circulation 2007;116: Felker GM, Rogers JG. Same bridge, new destinations rethinking paradigms for mechanical cardiac support in heart failure. J Am Coll Cardiol 2006;47: Miller LW, Lietz K. Candidate selection for long-term left ventricular assist device therapy for refractory heart failure. J Heart Lung Transplant 2006;25: Pagani FD, Long JW, Dembitsky WP, Joyce LD, Miller LW. Improved mechanical reliability of the HeartMate XVE left ventricular assist system. Ann Thorac Surg 2006;82: Stevenson LW, Miller LW, Desvigne-Nickens P, et al. Left ventricular assist device as destination for patients undergoing intravenous inotropic therapy: a subset analysis from REMATCH (Randomized Evaluation of Mechanical Assistance in Treatment of Chronic Heart Failure). Circulation 2004;110: Stevenson LW, Rose EA. Left ventricular assist devices: bridges to transplantation, recovery, and destination for whom? Circulation 2003;108: Holman WL, Park SJ, Long JW, et al. Infection in permanent circulatory support: experience from the REMATCH trial. J Heart Lung Transplant 2004;23: Lazar RM, Shapiro PA, Jaski BE, et al. Neurological events during long-term mechanical circulatory support for heart failure: the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) experience. Circulation 2004;109: Kirklin JK, Naftel DC, Stevenson LW, et al. INTERMACS database for durable devices for circulatory support: first annual report. J Heart Lung Transplant 2008;27: Lewis EF, Johnson PA, Johnson W, Collins C, Griffin L, Stevenson LW. Preferences for quality of life or survival expressed by patients with heart failure. J Heart Lung Transplant 2001;20: Stevenson LW, Hellkamp AS, Leier CV, et al. Changing preferences for survival after hospitalization with advanced heart failure. J Am Coll Cardiol 2008;52: Brophy JM, Dagenais GR, McSherry F, Williford W, Yusuf S. A multivariate model for predicting mortality in patients with heart failure and systolic dysfunction. Am J Med 2004;116: Pocock SJ, Wang D, Pfeffer MA, et al. Predictors of mortality and morbidity in patients with chronic heart failure. Eur Heart J 2006;27: Teuteberg JJ, Lewis EF, Nohria A, et al. Characteristics of patients who die with heart failure and a low ejection fraction in the new millennium. J Cardiac Fail 2006;12: Lee DS, Austin PC, Rouleau JL, Liu PP, Naimark D, Tu JV. Predicting mortality among patients hospitalized for heart failure: derivation and validation of a clinical model. JAMA 2003;290: Levy WC, Mozaffarian D, Linker DT, et al. The Seattle Heart Failure Model: prediction of survival in heart failure. Circulation 2006;113: Allen LA, Yager JE, Funk MJ, et al. Discordance between patientpredicted and model-predicted life expectancy among ambulatory patients with heart failure. JAMA 2008;299: Lima B, Kherani AR, Hata JA, et al. Does a pre-left ventricular assist device screening score predict long-term transplantation success? A 2-center analysis. Heart Surg Forum 2006;9:E Huang R, Deng M, Rogers JG, et al. Effect of age on outcomes after left ventricular assist device placement. Transplant Proc 2006;38: Packer M, Coats AJ, Fowler MB, et al. Effect of carvedilol on survival in severe chronic heart failure. N Engl J Med 2001;344: Pitt B, Zannad F, Remme WJ, et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med 1999;341: Chen JM, Naka Y, Rose EA. The future of left ventricular assist device therapy in adults. Nat Clin Pract Cardiovasc Med 2006;3: Miller LW, Pagani FD, Russell SD, et al. Use of a continuous-flow device in patients awaiting heart transplantation. N Engl J Med 2007;357: Kirklin JK, Holman WL. Mechanical circulatory support therapy as a bridge to transplant or recovery (new advances). Curr Opin Cardiol 2006;21: Pagani FD, Stevenson LW, Kirklin JK, Naftel D, Kormos R, Young J. Influence of patient profiles on outcomes with implantable mechanical circulatory support (MCS): results from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERACS). Circulation 2007;116:II Pagani FD, Stevenson LW, Ulisney K, et al. Pre-implant triage using patient status with INTERMACS patient profiles: can we refine selection strategy for MCS? J Heart Lung Transplant 2008;27:S60. APPENDIX Ventricular Assist Device Survey Left ventricular assist devices are currently available that can be put in to support the heart when heart failure becomes very severe and the heart is too weak to pump enough blood to the body. This requires a major cardiac surgery and the device is put into your left upper abdomen. Hospital recovery is generally about 4 weeks before patients return home. There are currently several investigational devices and one approved device for this purpose.

7 The Journal of Heart and Lung Transplantation Stewart et al. 869 Volume 28, Number 9 Suppose that your heart failure were so bad that nothing else could be done for you. If you could not get out of bed and were told that you would be dead soon, would you consider a left ventricular assist device put in that would allow you to move around comfortably and live longer? 1. Which statement best describes how you would feel about having an assist device in this situation? A. I would DEFINITELY WANT it B. I would PROBABLY WANT it C. I don t know if I would want it or not D. I would PROBABLY NOT WANT it E. I would DEFINITELY NOT WANT it 2. If probably or definitely not, which of the following describe how you feel? Please circle ALL answers that apply A. I wouldn t mind dying now B. I don t like the idea of going through major surgery to put in the device C. I do not want to depend on a machine D. There are too many complications to worry about E. I believe that I should go peacefully when my time comes F. I don t want to have a machine inside me keeping me alive G. I do not feel that I have any good reason to live longer H. I don t want to worry about the batteries running down when I am away from the charger I. I don t think that my family and I could learn to manage the device at home 3. Knowing nothing else besides the above information, how sick would you have to be to consider such a device in order to prolong your life? Circle the first answer that fits. A. Less than 1 month to live B. Less than 6 months to live C. Less than 1 year to live D. Less than 2 years to live 4. Knowing nothing else besides the above information, how sick would you have to be to consider such a device in order to be more active? Circle the first answer that fits. A. Too sick to get out of bed B. Too sick to get dressed without stopping to rest C. Too sick to walk 1 block, but comfortable resting at home D. Too sick to walk 5 blocks, but comfortable at rest and going out in car E. Too sick to travel without using a wheelchair at the airport 5. Which information about the device would be important to your decision about whether to have one? How long you would survive with it and/or how your quality of life would be with it? Circle ONE choice below: Only survival information More survival than quality of life Equal survival and quality of life Quality of life more important than survival Quality only Consider the following: Device Type A weighs about 2½ pounds, is about 6 inches in diameter, and is placed in the left upper abdomen. It is connected to an external console that rolls, and can also be supported with batteries that are worn in a vest. The batteries have to be changed every 4 6 hours. The device movement can be felt with every beat, and it makes a rhythmic noise as it pumps, which is obvious in the room and at the movies. This is the approved device about which we have most information. If 10 people like yourself got this device, it is expected that 6 would be alive 1 year later and 3 would be alive at 2 years. The most common complications are infections and device failures requiring return to hospital and sometimes replacement of the device. Strokes have occasionally occurred. Patients are able to sleep, eat, and walk comfortably. Many are able to do light exercise such as bicycling and golf. There are several newer devices (Device Type B) that are about the size of 3 thumbs. They fit easily into the abdomen or lower chest, where they are not easily seen. They are light in weight and make almost no audible noise. Type B devices are not approved yet, so there is not as much information for Type B devices as there is for Type A devices about what happens to people with them. The failure rate seems to be lower, but the rate of stroke seems to be slightly higher than with Device Type A (still less than 1 patient in 5). Survival at 6 months appears to be similar to survival with Device Type A but not much is known after that. 6. Knowing only this information, which device would you want if you were to have a device? Circle one answer below. Type A Type A Don t know Type B Type B Definitely Probably Probably Definitely 7. Which features would be most important to you if you had more information? Number these 1 to 5. Size and weight of device Noise of device as it pumps How long the devices last without being replaced How often strokes occur How much activity patients can do How long patients survive How long I can go before having to change batteries (currently every 4 hours)