Authors: Osama Alsara, MD Ronald K. Reeves, MD Mary D. Pyfferoen, PT, MA Tamra L. Trenary, OTD Deborah J. Engen, OT, MBA Merri L. Vitse, OTA Stacy M. Kessler, MD Sudhir S. Kushwaha, MD Alfredo L. Clavell, MD Randal J. Thomas, MD, MSc Francisco Lopez-Jimenez, MD, MSc Soon J. Park, MD Carmen M. Perez-Terzic, MD, PhD
Affiliations: From the Department of Internal Medicine, Division of Cardiovascular Diseases (OA, SSK, ALC, RJT, FL-J, CMP-T), Department of Physical Medicine and Rehabilitation (RKR, MDP, TLT, DJE, MLV, SMK, CMP-T), and Department of Cardiac Surgery (SJP), Mayo Clinic, Rochester, Minnesota.
Correspondence: All correspondence and requests for reprints should be addressed to: Carmen M. Perez-Terzic, MD, PhD, Departments of Physical Medicine and Rehabilitation and Internal Medicine, Division of Cardiovascular Diseases, Mayo Clinic College of Medicine, 200 First St, SW, Rochester, MN 55905.
Disclosures: Financial disclosure statements have been obtained, and no conflicts of interest have been reported by the authors or by any individuals in control of the content of this article.
0894-9115/14/9310-0860 American Journal of Physical Medicine & Rehabilitation Copyright * 2014 by Lippincott Williams & Wilkins DOI: 10.1097/PHM.0000000000000101
Inpatient Rehabilitation
ORIGINAL RESEARCH ARTICLE
Inpatient Rehabilitation Outcomes for Patients Receiving Left Ventricular Assist Device ABSTRACT Alsara O, Reeves RK, Pyfferoen MD, Trenary TL, Engen DJ, Vitse ML, Kessler SM, Kushwaha SS, Clavell AL, Thomas RJ, Lopez-Jimenez F, Park SJ, Perez-Terzic CM: Inpatient rehabilitation outcomes for patients receiving left ventricular assist device. Am J Phys Med Rehabil 2014;93:860Y868.
Objective: The aim of this study was to evaluate outcomes of patients participating in inpatient rehabilitation program after left ventricular assist device (LVAD) implantation.
Design: Medical records of 94 patients who received LVADs between January 1, 2008, and June 30, 2010, at the Mayo Clinic in Rochester, MN, were retrospectively reviewed for demographic data, and inpatient rehabilitation functional outcomes were measured by the Functional Independence Measure scale.
Results: After successful implantation of LVAD, the patients were either discharged directly home from acute care (44%) or admitted to inpatient rehabilitation (56%). The patients admitted to inpatient rehabilitation were older than those discharged home. They were also more medically complex and more likely to have the LVAD placed as destination therapy. At discharge, significant improvement occurred in 17 of the 18 activities evaluated by the Functional Independence Measure scale. The mean total Functional Independence Measure scale score at admission was 77.1 compared with a score of 95.2 at discharge (P G 0.0001).
Conclusions: Approximately half of the patients who received LVAD therapy were admitted in the inpatient rehabilitation. After the implantation of LVAD and inpatient rehabilitation, significant functional improvements were observed. Further studies addressing the role of inpatient rehabilitation for LVAD patients are warranted. Key Words: Left Ventricular Assist Device, Inpatient Rehabilitation, Functional Independence Measure, Heart Failure
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nd-stage heart failure (HF) resistant to medical therapy affects approximately 250,000 Americans.1 Heart transplantation is the criterion standard therapy for these patients; however, only 2200 heart transplantations are performed in the United States annually.2 To improve the quality-of-life and reduce mortality in HF patients who are waiting for heart transplantation, left ventricular assist devices (LVADs) were introduced in the 1980s as a bridgeto-transplantation therapy. The LVAD is a surgically implanted pump that provides circulatory support by pulling blood from the left ventricle and sending it into the aorta. More recently, LVADs have been used as long-term treatment of patients who are not candidates for heart transplantation.3 This form of LVAD support known as destination therapy was approved by the Food and Drug Administration specifically for the HeartMate II LVAD. In this regard, recent studies show that LVADs improve survival in HF patients who are inotropic dependent by improving exercise tolerance,4Y8 cardiac and noncardiac organ function, and quality-of-life.9 Patients who receive an LVAD still experience a variety of medical issues including physical and functional impairments, as well as psychosocial problems. Patients with LVAD are at risk for other postsurgical complications including bleeding, dehydration, fluid overload, stroke, arrhythmias, right ventricular failure, hypertension, hypotension, tamponade, infections, percutaneous lead site tearing, and hemolysis.10 As a consequence, the postoperative care and support of patients with LVAD device are a complicated process requiring a multidisciplinary approach including cardiothoracic surgeons, cardiovascular physicians, physiatrists, physical and occupational therapists, and nurses, who are all essential to minimize avoidable morbidity and maximize functional improvement and quality-of-life. Rehabilitation services can play a critical role in the recovery of patients after LVAD implantation. Within the authors’ center, rehabilitation services
TABLE 1 Criteria for admission to inpatient rehabilitation Need for regular visits by a rehabilitation physician Need for rehabilitation nurse care Need for at least 3 hrs of therapy per day from two different types of therapy (physical therapy, occupational therapy, or speech pathology)
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TABLE 2 The items of the FIM instrument Functional items Eating, grooming, bathing, upper of FIM body dressing, lower body dressing, toileting, bladder, bowel, toilet transfer, bed/chair/wheelchair transfer, tub/shower transfer, walking or wheelchair mobility, stair climbing Cognitive items Comprehension, expression, social of FIM interaction, problem solving, and memory
are involved early in the care of patients with LVADs. Physical and occupational therapists as well as physiatrists assist the patient with functional limitations that impact self-care, mobility, home management, and LVAD device management. For individuals with severe functional limitations, inpatient rehabilitation has been shown to improve outcomes such as functional capacity and qualityof-life and survival in patients with chronic illnesses and long hospitalizations and after complex surgeries.11Y16 In patients with LVADs, the goal of rehabilitation is to restore physical and mental function so patients may resume meaningful activities while using and caring for their LVAD. Relatively little is known about which LVAD patients are likely to require inpatient rehabilitation and how functional outcomes improve after LVAD placement. Therefore, the objective of this study was to describe the demographics and evaluate the functional outcomes of patients who underwent LVAD therapy and inpatient rehabilitation at the Mayo Clinic in Rochester, MN.
MATERIALS AND METHODS The electronic medical records of patients who received LVADs at the Mayo Clinic from January 1, 2008, to June 30, 2010, were retrospectively reviewed. Data collected included demographics, cardiac diagnoses, comorbid conditions, smoking status, marital status, medication use, indication for LVAD, type of LVAD device, length of stay in acute care after LVAD implantation, acute care discharge location, and rehabilitation discharge location. Functional Independence Measure (FIM) scores were collected on all inpatient rehabilitation patients per standard protocol. All consecutive adult patients who received LVAD implantation during the period were included. Patients who declined to permit the use of their medical records for retrospective research were excluded from this study. All LVAD systems were approved by the Food and Drug Administration for implantation Inpatient Rehab and Functional Improvement
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FIGURE 1 FIM scores. Definition and values of each individualized FIM score. Max Assist indicates maximum assist; Min Assist, minimum assist; Mod Assist, moderate assist; Mod Indep, moderate independent.
in cardiac patients. This study was approved by the Institutional Research Board at the Mayo Clinic, Rochester, MN.
Rehabilitation Services Role in Management of LVAD Patients at the Mayo Clinic After LVAD implantation, the patients admitted to the cardiovascular acute care unit are evaluated by rehabilitation physicians, nurses, and therapists. Individuals with significant functional limitations or cognitive deficits are evaluated for inpatient
rehabilitation. Table 1 summarizes the criteria for admission to inpatient rehabilitation. During inpatient rehabilitation, an individual plan of care is created for each patient to address impairments, activity limitations, and participation restrictions as well as their ongoing medical needs. The interdisciplinary medical team includes rehabilitation nurses; occupational, physical speech, and recreational therapists; social workers; psychologists; and physiatrists. The FIM instrument is the most widely accepted functional assessment measure in use in the rehabilitation community for assessment of
FIGURE 2 Flow of LVAD patients. Flow of patients who received LVAD therapy between January 2008 and June 2010 at the Mayo Clinic, Rochester, MN.
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Am. J. Phys. Med. Rehabil. & Vol. 93, No. 10, October 2014
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progress during inpatient rehabilitation.17 It evaluates 18 functional and cognitive areas, as shown in Table 2. FIM score ranges between 1 and 7 on each item of the measure (Fig. 1). The sum of the individual scores is the total FIM score. The total score range is from 18 (lowest) to 126 (highest).18Y20 In this study, FIM assessment is given at the beginning and the end of the inpatient rehabilitation program, to determine the patient’s admission and dismissal functional status. Comparison of FIM scores at admission and discharge was performed to assess functional and cognitive changes during inpatient rehabilitation.
Statistical Analysis Data are expressed as mean (standard deviation). FIM data were treated as ordinal data for the analysis. Paired data were compared using t test.
Wilcoxon’s rank-sum test was used as well for nonparametric data. All tests were two tailed, and P G 0.05 was considered statistically significant. Data were analyzed using JMP 8 software (SAS Institute Inc, Cary, NC).
RESULTS Demographics of Patients Who Received LVAD Implantation Between January 2008 and June 2010, a total of 97 LVAD implantations took place at the Mayo Clinic in Rochester, MN. Because three of those surgeries were for LVAD reimplantations, this study’s population included 94 patients with a mean (SD) age of 60 (12) yrs (25Y79 yrs). After LVAD implantation, all patients were admitted to the acute care unit at Saint Mary’s Hospital. Survival to
TABLE 3 General characteristics of patients undergoing LVAD therapy at the Mayo Clinic in Rochester, MN, between January 1, 2008, and June 30, 2010 Age, mean (SD), yrs Sex, n (%) Male Female Race/ethnicity, n (%) Non-Hispanic white African American Hispanic Asian Unknown BMI, mean (SD) Marital status, n (%) Married Divorced Single Widowed Others Type of LVAD device, n (%) HM-II XVE VA DH Type of cardiomyopathy, n (%) Ischemic Nonischemic (total) Idiopathic Dilated Hypertrophic Other Mixed Reason for LVAD, n (%) Destination therapy Bridge to transplantation LOS in hospital after LVAD implantation, mean (SD), days Place of dismissal, n (%) Home Rehabilitation facility
60 (1) 80 (85.1) 14 (14.9) 82 (87.2) 2 (2.1) 1 (1.1) 2 (2.1) 7 (7.4) 29.53 (5.8) 75 (79.8) 8 (8.5) 6 (6.4) 2 (2.1) 3 (3.2) 84 (89.4) 3 (3.2) 6 (6.4) 1 (1.1) 37 (39.4) 54 (57.4) 23 (42.6) 14 (25.9) 5 (9.3) 12 (22.2) 3 (3.2) 59 (62.8) 35 (37.2) 20.20 (14.29) 37 (39.4) 47 (50.0)
BMI, body mass index; HM-II, HeartMate II; LOS, length of stay; XVE, The Thoratec HeartMate; VA, VentrAssist; DH, DuraHeart.
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TABLE 4 Comparison between LVAD patients admitted to inpatient rehabilitation program and patients dismissed to home after the acute care
Age, mean (SD), yrs Sex, n (%) Male Female Race, n (%) White Black Asian Not known BMI, mean (SD) Marital status, n (%) Married Divorced Single Widowed Other Smoking, n (%) Comorbidities, n (%) Cancer Sleep apnea HTN Stroke Depression DM Hyperlipidemia Renal Medications, n (%) ACEI Beta blockers Statins Insulin Aspirin Anticoagulant Antiarrhythmic Inotropics Defibrillator, n (%) Type of LVAD, n (%) HM-II XVE DH VA HF diagnoses, n (%) Ischemic Nonischemic Idiopathic Dilated Hypertrophic Others Mixed Reason for LVAD,a n (%) Destination Bridge LOS, mean (SD), days
Patients Admitted to Inpatient Rehabilitation (n = 47)
Patients Dismissed to Home (n = 37)
64.7 (8.7)
55.3 (14.9)a
40 (85.1) 7 (14.9)
31 (83.8) 6 (16.2)
41 (87.2) 1 (2.1) 1 (2.1) 4 (8.5) 28.66 (5.64)
33 (89.2) 1 (2.7) 1 (2.7) 2 (5.4) 30.01 (5.43)
39 4 1 2 1 3
(83) (8.5) (2.1) (4.2) (2.1) (6.4)
28 (75.7) 4 (10.8) 3 (8.1) 0 2 (5.4) 6 (16.2)
7 13 18 7 13 17 24 28
(14.9) (27.7) (38.3) (14.9) (27.7) (36.2) (51.1) (59.6)
2 (5.4) 13 (35.1) 11 (29.7) 7 (18.9) 9 (24.3) 9 (24.3)a 22 (59.5) 14 (37.8)a
10 11 6 15 39 44 32 27 17
(21.3) (23.4) (12.8) (31.9) (83) (93.6) (68.1) (57.4) (36.2)
9 (24.3) 11 (29.7) 10 (27) 2 (5.4)a 31 (83.8) 35 (94.6) 25 (67.6) 27 (72.9) 20 (54.1)
44 (93.6) 2 (4.3) 1 (2.1) 0
31 (83.8) 0 0 6 (16.2)
20 26 11 7 3 5 1
16 (43.2) 21 (56.8) 10 (27.0) 5 (13.5) 2 (5.4) 4 (10.8) 0
(42.6) (55.3) (42.3) (26.9) (11.5) (19.2) (2.1)
36 (76.6) 11 (23.4) 19.52 (12.71)
20 (54.1) 17 (45.9) 21.13 (13.86)
LVAD, left ventricular assist device; ACEI, angiotensin-converting enzyme inhibitor; BMI, body mass index; DM, diabetes mellitus; HM-II, HeartMate II; HTN, hypertension; LOS, length of stay.
acute hospital discharge in this study was 89.4% because ten patients died within 20.2 (23.5) days after LVAD implantation for reasons including multisystem organ failure (eight patients), cerebral
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infarction (one patient), and cardiopulmonary arrest (one patient). In the intensive care unit, the patients received acute care rehabilitation services and were evaluated
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in regard to the criteria for admission to inpatient rehabilitation. Forty-seven patients met those criteria (Table 1) and were admitted to the inpatient rehabilitation unit at Saint Mary’s Hospital, Rochester, MN, which represents 50% of this study’s total cohort. Thirty-seven patients (39.4%) were discharged home from acute care (Fig. 2). In this study, most LVAD recipients were men (85.1%). The etiology of HF was most commonly ischemic, followed by idiopathic. LVAD HeartMate II systems were the most implanted devices, and most LVADs were placed as destination therapy. The patients’ demographics are summarized in Table 3.
Demographics of LVAD Patients Admitted to Inpatient Rehabilitation Program Comparison between the group of LVAD patients admitted to inpatient rehabilitation program and the LVAD patients discharged home regarding demographics, comorbidities, and outcomes is shown
in Table 4. The patients in both groups were similar except for age, insulin use, and the prevalence of renal failure (Table 4). This study’s follow-up data showed that 10.6% of the patients admitted to inpatient rehabilitation program underwent post-LVAD heart transplantation, compared with 37.8% of the patients discharged home.
FIM Scores at Admission and Discharge from Inpatient Rehabilitation Unit The LVAD patients stayed in the inpatient rehabilitation program for a mean (SD) of 6.6 (3.9) days (between 1 and 16 days). The patients admitted to inpatient rehabilitation had their functional status evaluated during the admission and discharge assessment periods using the FIM instrument. Analysis of both measurements showed a significant improvement in all of the functional and cognitive items at discharge compared with their status at the time of admission, except for bowel control, which changed at
FIGURE 3 Changes in FIM scores of LVAD patients between admission to and discharge from inpatient rehabilitation program. A, The x-axis represents the physical and cognitive items that are assessed for patients in inpatient rehabilitation program. The y-axis represents the FIM score. For each item, FIM score is represented both at admission (purple) and discharge (red). Asterisk represents significant differences (P G 0.0001). B, FIM wheel displays each item of the 18 FIM components represented as a line from the center of the wheel and divided from 1 to 7 (scores). Admission and discharge FIM scores for a specific item are represented by two dots on the line belonging to that item. The gray areas represent the improvement in FIM scores of LVAD patients between admission to and discharge from inpatient rehabilitation program. Significant improvement was achieved in most of the cognitive and physical domains in LVAD patients completing an inpatient rehabilitation program. www.ajpmr.com
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FIGURE 4 Change in total FIM score of LVAD patients admitted to inpatient rehabilitation program. On the x-axis is the mean value of discharge and admission total FIM. On the y-axis is the difference between the discharge and admission FIM scores. Each dot represents an individual patient in the study. The solid red horizontal line represents the mean FIM change, and the two dotted red horizontal lines represent the confidence intervals for the population. FIM change in relation to the admission FIM score demonstrates that virtually most patients admitted to inpatient rehabilitation experience a positive change in their functional status, and the amount of change is only slightly related to the admission FIM score.
discharge, but not significantly (P = 0.25; Figs. 3A, B). When comparing the total score at admission and discharge, total FIM score improved significantly (77.1 vs. 95.2; P G 0.0001; Fig. 4).
DISCUSSION The main finding in this retrospective descriptive study is that the patients with LVAD had significant improvements in their functional status after a relatively short stay in the inpatient rehabilitation program. The present study is of importance considering the increasing numbers of HF patients receiving LVADs as both destination and bridge therapy and the fact that the postoperative care of these patients is complex because of multiple medical issues associated with chronic and debilitating diseases. Therefore, a multidisciplinary approach involving cardiovascular surgeons, cardiovascular physicians, and other healthcare professionals should be considered to minimize morbidity and improve the quality-of-life in these patients. Consequently, the role of physiatrists, therapists, and rehabilitation nurses, in a hospital-based setting, could be essential in the postsurgical care of these patients. Fifty percent of the patients in this study’s population were admitted to the authors’ inpatient rehabilitation unit. As expected, on the basis of the
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design of the authors’ program, older individuals and those with greater medical complexity (renal failure, diabetes, destination LVAD therapy) were more likely to require admission to inpatient rehabilitation. This study shows the positive impact of the inpatient rehabilitation program on 17 functional and cognitive skills of the 18 items measured by the FIM instrument. In addition, the data of this study demonstrated a significant improvement in the total FIM score in agreement with the available literature. Nissinoff and colleagues21 reported three cases of patients admitted to inpatient rehabilitation after LVAD implantation, in which FIM score improved from 76, 66, and 67 at admission to 108, 84, and 98, respectively, at discharge. Nguyen and Stein22 studied 11 patients who underwent LVAD placement and required inpatient rehabilitation. These patients stayed for 17.5 (8.9) days and achieved a mean FIM gain of 28.6. Similarly, English and Speed23 found in 20 of LVAD patients that mean total FIM score improved by 22.05 after 11.6 days in the inpatient rehabilitation unit. Despite the medical complexity in the group of patients admitted to inpatient rehabilitation, FIM scores for both cognitive and physical function significantly improved during the rehabilitation program. Previous studies have shown that a high FIM score at discharge from inpatient rehabilitation programs is a predictor of quality-of-life and survival in specific
Am. J. Phys. Med. Rehabil. & Vol. 93, No. 10, October 2014
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populations, suggesting that this may also be the case in LVAD patients.15,24Y26 However, studies evaluating long-term outcomes of patients participating in rehabilitation after LVAD therapy need to be explored in the future. This study had certain limitations that should be noted. This was a retrospective analysis of medical records, thus limiting data analysis to variables that were available to the authors. Moreover, the numbers of participants in this study are modest, not allowing the authors to do subgroup analyses with good statistical power. The functional improvement noted in this study may be attributed in part to the effect of LVAD itself. Because FIM score is used only during inpatient rehabilitation, the authors do not know the level of activity in the patients who were discharged home directly from the acute setting, and they could not compare the improvement in physical activity with those patients as a control group of the LVAD patients who were not admitted to inpatient rehabilitation. In addition, this study included data from one inpatient rehabilitation program with limited ethnic diversity; therefore, these findings may not be generalized to other programs.
CONCLUSIONS Approximately half of the patients receiving LVAD therapy in this study cohort required inpatient rehabilitation before discharge to home. Older patients, those who require LVAD implantation as destination therapy, and those with greater medical complexity such as renal failure and diabetes were more likely to require inpatient rehabilitation. Individuals who undergo an LVAD implantation followed by inpatient rehabilitation have a significant improvement in functional and cognitive status. Therefore, involvement of therapy services and participation in inpatient rehabilitation programs should be strongly considered in patients receiving LVAD. REFERENCES 1. Ferris H, Hunt S: Destination ventricular assist devices for heart failure #205. J Palliat Med 2009;12: 956Y7 2. Daneshmand MA, Rajagopal K, Lima B, et al: Left ventricular assist device destination therapy versus extended criteria cardiac transplant. Ann Thorac Surg 2010;89:1205Y9; discussion 1210 3. Rose EA, Gelijns AC, Moskowitz AJ, et al, for the REMATCH Study Group: Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med 2001;345:1435Y43 www.ajpmr.com
4. Morrone TM, Buck LA, Catanese KA, et al: Early progressive mobilization of patients with left ventricular assist devices is safe and optimizes recovery before heart transplantation. J Heart Lung Transplant 1996;15:423Y9 5. Pina IL, Apstein CS, Balady GJ, et al: Exercise and heart failure: A statement from the American Heart Association Committee on exercise, rehabilitation, and prevention. Circulation 2003;107:1210Y25 6. Nishimura M, Radovancevic B, Odegaard P, et al: Exercise capacity recovers slowly but fully in patients with a left ventricular assist device. ASAIO J 1996;42: M568Y70 7. de Jonge N, Kirkels H, Lahpor JR, et al: Exercise performance in patients with end-stage heart failure after implantation of a left ventricular assist device and after heart transplantation: An outlook for permanent assisting? J Am Coll Cardiol 2001;37:1794Y9 8. Levin HR, Chen JM, Oz MC, et al: Potential of left ventricular assist devices as outpatient therapy while awaiting transplantation. Ann Thorac Surg 1994;58: 1515Y20 9. Kennedy MD, Haykowsky M, Humphrey R: Function, eligibility, outcomes, and exercise capacity associated with left ventricular assist devices: Exercise rehabilitation and training for patients with ventricular assist devices. J Cardiopulm Rehabil 2003;23:208Y17 10. Slaughter MS, Pagani FD, Rogers JG, et al: Clinical management of continuous-flow left ventricular assist devices in advanced heart failure. J Heart Lung Transplant 2010;29(suppl):S1Y39 11. Suoyrjo H, Hinkka K, Oksanen T, et al: Effects of multidisciplinary inpatient rehabilitation for chronic back or neck pain: A register-linkage study of sickness absences and analgesic purchases in an occupational cohort. Occup Environ Med 2008;65:179Y84 12. Lee CK: Effects of an inpatient pulmonary rehabilitation program on dyspnea, exercise capacity, and health related quality of life for patients with chronic lung disease. Taehan Kanho Hakhoe Chi 2007;37:343Y52 13. Gutenbrunner C, Gundermann G, Hager G, et al: Prospective study of the long-term effectiveness of inpatient rehabilitation of patients with chronic cervicobrachial syndromes and the effect of prescribing special functional pillows. Rehabilitation (Stuttg) 1999;38:170Y6 14. Bowen JB, Thrall RS, ZuWallack RL, et al: Long-term benefits of short-stay inpatient pulmonary rehabilitation in severe chronic obstructive pulmonary disease. Monaldi Arch Chest Dis 1999;54:189Y92 15. Tang V, Rathbone M, Park Dorsay J, et al: Rehabilitation in primary and metastatic brain tumours: Impact of functional outcomes on survival. J Neurol 2008;255:820Y7 16. Dombo O, Otto U: Quality of life after radical urologic pelvic surgery and impact of inpatient rehabilitation. Urologe A 2005;44:11Y28 17. Chumney D, Nollinger K, Shesko K, et al: Ability of Functional Independence Measure to accurately
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predict functional outcome of stroke-specific population: systematic review. J Rehabil Res Dev 2010; 47:17Y29 18. Lieberman D, Friger M: Inpatient rehabilitation outcome after hip fracture surgery in elderly patients: A prospective cohort study of 946 patients. Arch Phys Med Rehabil 2006;87:167Y71 19. Petitpierre NJ, Trombetti A, Carroll I, et al: The FIM instrument to identify patients at risk of falling in geriatric wards: A 10-year retrospective study. Age Ageing 2010;39:326Y31 20. Stineman MG, Shea JA, Jette A, et al: The Functional Independence Measure: Tests of scaling assumptions, structure, and reliability across 20 diverse impairment categories. Arch Phys Med Rehabil 1996;77:1101Y8 21. Nissinoff J, Tian F, Theratti M, et al: Acute inpatient rehabilitation after left ventricular assist device implantation for congestive heart failure. PM R 2011;3: 586Y9
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22. Nguyen E, Stein J: Functional outcomes of adults with left ventricular assist devices receiving inpatient rehabilitation. PM R 2013;5:99Y103. doi:10.1016/ j.pmrj.2012.12.003 23. English ML, Speed J: Effectiveness of acute inpatient rehabilitation after left ventricular assist device placement. Am J Phys Med Rehabil 2012;92:621Y6 24. Giaquinto S, Giachetti I, Spiridigliozzi C, et al: Quality of life after stroke in a rehabilitation setting. Clin Exp Hypertens 2010;32:426Y30 25. Huang YH, Wu CY, Hsieh YW, et al: Predictors of change in quality of life after distributed constraintinduced therapy in patients with chronic stroke. Neurorehabil Neural Repair 2010;24:559Y66 26. Tang V, Harvey D, Park Dorsay J, et al: Prognostic indicators in metastatic spinal cord compression: Using functional independence measure and Tokuhashi scale to optimize rehabilitation planning. Spinal Cord 2007;45:671Y7
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Affiliations: From the Department of Internal Medicine, Division of Cardiovascular Diseases (OA, SSK, ALC, RJT, FL-J, CMP-T), Department of Physical Medicine and Rehabilitation (RKR, MDP, TLT, DJE, MLV, SMK, CMP-T), and Department of Cardiac Surgery (SJP), Mayo Clinic, Rochester, Minnesota.
Correspondence: All correspondence and requests for reprints should be addressed to: Carmen M. Perez-Terzic, MD, PhD, Departments of Physical Medicine and Rehabilitation and Internal Medicine, Division of Cardiovascular Diseases, Mayo Clinic College of Medicine, 200 First St, SW, Rochester, MN 55905.
Disclosures: Financial disclosure statements have been obtained, and no conflicts of interest have been reported by the authors or by any individuals in control of the content of this article.
0894-9115/14/9310-0860 American Journal of Physical Medicine & Rehabilitation Copyright * 2014 by Lippincott Williams & Wilkins DOI: 10.1097/PHM.0000000000000101
Inpatient Rehabilitation
ORIGINAL RESEARCH ARTICLE
Inpatient Rehabilitation Outcomes for Patients Receiving Left Ventricular Assist Device ABSTRACT Alsara O, Reeves RK, Pyfferoen MD, Trenary TL, Engen DJ, Vitse ML, Kessler SM, Kushwaha SS, Clavell AL, Thomas RJ, Lopez-Jimenez F, Park SJ, Perez-Terzic CM: Inpatient rehabilitation outcomes for patients receiving left ventricular assist device. Am J Phys Med Rehabil 2014;93:860Y868.
Objective: The aim of this study was to evaluate outcomes of patients participating in inpatient rehabilitation program after left ventricular assist device (LVAD) implantation.
Design: Medical records of 94 patients who received LVADs between January 1, 2008, and June 30, 2010, at the Mayo Clinic in Rochester, MN, were retrospectively reviewed for demographic data, and inpatient rehabilitation functional outcomes were measured by the Functional Independence Measure scale.
Results: After successful implantation of LVAD, the patients were either discharged directly home from acute care (44%) or admitted to inpatient rehabilitation (56%). The patients admitted to inpatient rehabilitation were older than those discharged home. They were also more medically complex and more likely to have the LVAD placed as destination therapy. At discharge, significant improvement occurred in 17 of the 18 activities evaluated by the Functional Independence Measure scale. The mean total Functional Independence Measure scale score at admission was 77.1 compared with a score of 95.2 at discharge (P G 0.0001).
Conclusions: Approximately half of the patients who received LVAD therapy were admitted in the inpatient rehabilitation. After the implantation of LVAD and inpatient rehabilitation, significant functional improvements were observed. Further studies addressing the role of inpatient rehabilitation for LVAD patients are warranted. Key Words: Left Ventricular Assist Device, Inpatient Rehabilitation, Functional Independence Measure, Heart Failure
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E
nd-stage heart failure (HF) resistant to medical therapy affects approximately 250,000 Americans.1 Heart transplantation is the criterion standard therapy for these patients; however, only 2200 heart transplantations are performed in the United States annually.2 To improve the quality-of-life and reduce mortality in HF patients who are waiting for heart transplantation, left ventricular assist devices (LVADs) were introduced in the 1980s as a bridgeto-transplantation therapy. The LVAD is a surgically implanted pump that provides circulatory support by pulling blood from the left ventricle and sending it into the aorta. More recently, LVADs have been used as long-term treatment of patients who are not candidates for heart transplantation.3 This form of LVAD support known as destination therapy was approved by the Food and Drug Administration specifically for the HeartMate II LVAD. In this regard, recent studies show that LVADs improve survival in HF patients who are inotropic dependent by improving exercise tolerance,4Y8 cardiac and noncardiac organ function, and quality-of-life.9 Patients who receive an LVAD still experience a variety of medical issues including physical and functional impairments, as well as psychosocial problems. Patients with LVAD are at risk for other postsurgical complications including bleeding, dehydration, fluid overload, stroke, arrhythmias, right ventricular failure, hypertension, hypotension, tamponade, infections, percutaneous lead site tearing, and hemolysis.10 As a consequence, the postoperative care and support of patients with LVAD device are a complicated process requiring a multidisciplinary approach including cardiothoracic surgeons, cardiovascular physicians, physiatrists, physical and occupational therapists, and nurses, who are all essential to minimize avoidable morbidity and maximize functional improvement and quality-of-life. Rehabilitation services can play a critical role in the recovery of patients after LVAD implantation. Within the authors’ center, rehabilitation services
TABLE 1 Criteria for admission to inpatient rehabilitation Need for regular visits by a rehabilitation physician Need for rehabilitation nurse care Need for at least 3 hrs of therapy per day from two different types of therapy (physical therapy, occupational therapy, or speech pathology)
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TABLE 2 The items of the FIM instrument Functional items Eating, grooming, bathing, upper of FIM body dressing, lower body dressing, toileting, bladder, bowel, toilet transfer, bed/chair/wheelchair transfer, tub/shower transfer, walking or wheelchair mobility, stair climbing Cognitive items Comprehension, expression, social of FIM interaction, problem solving, and memory
are involved early in the care of patients with LVADs. Physical and occupational therapists as well as physiatrists assist the patient with functional limitations that impact self-care, mobility, home management, and LVAD device management. For individuals with severe functional limitations, inpatient rehabilitation has been shown to improve outcomes such as functional capacity and qualityof-life and survival in patients with chronic illnesses and long hospitalizations and after complex surgeries.11Y16 In patients with LVADs, the goal of rehabilitation is to restore physical and mental function so patients may resume meaningful activities while using and caring for their LVAD. Relatively little is known about which LVAD patients are likely to require inpatient rehabilitation and how functional outcomes improve after LVAD placement. Therefore, the objective of this study was to describe the demographics and evaluate the functional outcomes of patients who underwent LVAD therapy and inpatient rehabilitation at the Mayo Clinic in Rochester, MN.
MATERIALS AND METHODS The electronic medical records of patients who received LVADs at the Mayo Clinic from January 1, 2008, to June 30, 2010, were retrospectively reviewed. Data collected included demographics, cardiac diagnoses, comorbid conditions, smoking status, marital status, medication use, indication for LVAD, type of LVAD device, length of stay in acute care after LVAD implantation, acute care discharge location, and rehabilitation discharge location. Functional Independence Measure (FIM) scores were collected on all inpatient rehabilitation patients per standard protocol. All consecutive adult patients who received LVAD implantation during the period were included. Patients who declined to permit the use of their medical records for retrospective research were excluded from this study. All LVAD systems were approved by the Food and Drug Administration for implantation Inpatient Rehab and Functional Improvement
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FIGURE 1 FIM scores. Definition and values of each individualized FIM score. Max Assist indicates maximum assist; Min Assist, minimum assist; Mod Assist, moderate assist; Mod Indep, moderate independent.
in cardiac patients. This study was approved by the Institutional Research Board at the Mayo Clinic, Rochester, MN.
Rehabilitation Services Role in Management of LVAD Patients at the Mayo Clinic After LVAD implantation, the patients admitted to the cardiovascular acute care unit are evaluated by rehabilitation physicians, nurses, and therapists. Individuals with significant functional limitations or cognitive deficits are evaluated for inpatient
rehabilitation. Table 1 summarizes the criteria for admission to inpatient rehabilitation. During inpatient rehabilitation, an individual plan of care is created for each patient to address impairments, activity limitations, and participation restrictions as well as their ongoing medical needs. The interdisciplinary medical team includes rehabilitation nurses; occupational, physical speech, and recreational therapists; social workers; psychologists; and physiatrists. The FIM instrument is the most widely accepted functional assessment measure in use in the rehabilitation community for assessment of
FIGURE 2 Flow of LVAD patients. Flow of patients who received LVAD therapy between January 2008 and June 2010 at the Mayo Clinic, Rochester, MN.
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progress during inpatient rehabilitation.17 It evaluates 18 functional and cognitive areas, as shown in Table 2. FIM score ranges between 1 and 7 on each item of the measure (Fig. 1). The sum of the individual scores is the total FIM score. The total score range is from 18 (lowest) to 126 (highest).18Y20 In this study, FIM assessment is given at the beginning and the end of the inpatient rehabilitation program, to determine the patient’s admission and dismissal functional status. Comparison of FIM scores at admission and discharge was performed to assess functional and cognitive changes during inpatient rehabilitation.
Statistical Analysis Data are expressed as mean (standard deviation). FIM data were treated as ordinal data for the analysis. Paired data were compared using t test.
Wilcoxon’s rank-sum test was used as well for nonparametric data. All tests were two tailed, and P G 0.05 was considered statistically significant. Data were analyzed using JMP 8 software (SAS Institute Inc, Cary, NC).
RESULTS Demographics of Patients Who Received LVAD Implantation Between January 2008 and June 2010, a total of 97 LVAD implantations took place at the Mayo Clinic in Rochester, MN. Because three of those surgeries were for LVAD reimplantations, this study’s population included 94 patients with a mean (SD) age of 60 (12) yrs (25Y79 yrs). After LVAD implantation, all patients were admitted to the acute care unit at Saint Mary’s Hospital. Survival to
TABLE 3 General characteristics of patients undergoing LVAD therapy at the Mayo Clinic in Rochester, MN, between January 1, 2008, and June 30, 2010 Age, mean (SD), yrs Sex, n (%) Male Female Race/ethnicity, n (%) Non-Hispanic white African American Hispanic Asian Unknown BMI, mean (SD) Marital status, n (%) Married Divorced Single Widowed Others Type of LVAD device, n (%) HM-II XVE VA DH Type of cardiomyopathy, n (%) Ischemic Nonischemic (total) Idiopathic Dilated Hypertrophic Other Mixed Reason for LVAD, n (%) Destination therapy Bridge to transplantation LOS in hospital after LVAD implantation, mean (SD), days Place of dismissal, n (%) Home Rehabilitation facility
60 (1) 80 (85.1) 14 (14.9) 82 (87.2) 2 (2.1) 1 (1.1) 2 (2.1) 7 (7.4) 29.53 (5.8) 75 (79.8) 8 (8.5) 6 (6.4) 2 (2.1) 3 (3.2) 84 (89.4) 3 (3.2) 6 (6.4) 1 (1.1) 37 (39.4) 54 (57.4) 23 (42.6) 14 (25.9) 5 (9.3) 12 (22.2) 3 (3.2) 59 (62.8) 35 (37.2) 20.20 (14.29) 37 (39.4) 47 (50.0)
BMI, body mass index; HM-II, HeartMate II; LOS, length of stay; XVE, The Thoratec HeartMate; VA, VentrAssist; DH, DuraHeart.
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TABLE 4 Comparison between LVAD patients admitted to inpatient rehabilitation program and patients dismissed to home after the acute care
Age, mean (SD), yrs Sex, n (%) Male Female Race, n (%) White Black Asian Not known BMI, mean (SD) Marital status, n (%) Married Divorced Single Widowed Other Smoking, n (%) Comorbidities, n (%) Cancer Sleep apnea HTN Stroke Depression DM Hyperlipidemia Renal Medications, n (%) ACEI Beta blockers Statins Insulin Aspirin Anticoagulant Antiarrhythmic Inotropics Defibrillator, n (%) Type of LVAD, n (%) HM-II XVE DH VA HF diagnoses, n (%) Ischemic Nonischemic Idiopathic Dilated Hypertrophic Others Mixed Reason for LVAD,a n (%) Destination Bridge LOS, mean (SD), days
Patients Admitted to Inpatient Rehabilitation (n = 47)
Patients Dismissed to Home (n = 37)
64.7 (8.7)
55.3 (14.9)a
40 (85.1) 7 (14.9)
31 (83.8) 6 (16.2)
41 (87.2) 1 (2.1) 1 (2.1) 4 (8.5) 28.66 (5.64)
33 (89.2) 1 (2.7) 1 (2.7) 2 (5.4) 30.01 (5.43)
39 4 1 2 1 3
(83) (8.5) (2.1) (4.2) (2.1) (6.4)
28 (75.7) 4 (10.8) 3 (8.1) 0 2 (5.4) 6 (16.2)
7 13 18 7 13 17 24 28
(14.9) (27.7) (38.3) (14.9) (27.7) (36.2) (51.1) (59.6)
2 (5.4) 13 (35.1) 11 (29.7) 7 (18.9) 9 (24.3) 9 (24.3)a 22 (59.5) 14 (37.8)a
10 11 6 15 39 44 32 27 17
(21.3) (23.4) (12.8) (31.9) (83) (93.6) (68.1) (57.4) (36.2)
9 (24.3) 11 (29.7) 10 (27) 2 (5.4)a 31 (83.8) 35 (94.6) 25 (67.6) 27 (72.9) 20 (54.1)
44 (93.6) 2 (4.3) 1 (2.1) 0
31 (83.8) 0 0 6 (16.2)
20 26 11 7 3 5 1
16 (43.2) 21 (56.8) 10 (27.0) 5 (13.5) 2 (5.4) 4 (10.8) 0
(42.6) (55.3) (42.3) (26.9) (11.5) (19.2) (2.1)
36 (76.6) 11 (23.4) 19.52 (12.71)
20 (54.1) 17 (45.9) 21.13 (13.86)
LVAD, left ventricular assist device; ACEI, angiotensin-converting enzyme inhibitor; BMI, body mass index; DM, diabetes mellitus; HM-II, HeartMate II; HTN, hypertension; LOS, length of stay.
acute hospital discharge in this study was 89.4% because ten patients died within 20.2 (23.5) days after LVAD implantation for reasons including multisystem organ failure (eight patients), cerebral
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infarction (one patient), and cardiopulmonary arrest (one patient). In the intensive care unit, the patients received acute care rehabilitation services and were evaluated
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in regard to the criteria for admission to inpatient rehabilitation. Forty-seven patients met those criteria (Table 1) and were admitted to the inpatient rehabilitation unit at Saint Mary’s Hospital, Rochester, MN, which represents 50% of this study’s total cohort. Thirty-seven patients (39.4%) were discharged home from acute care (Fig. 2). In this study, most LVAD recipients were men (85.1%). The etiology of HF was most commonly ischemic, followed by idiopathic. LVAD HeartMate II systems were the most implanted devices, and most LVADs were placed as destination therapy. The patients’ demographics are summarized in Table 3.
Demographics of LVAD Patients Admitted to Inpatient Rehabilitation Program Comparison between the group of LVAD patients admitted to inpatient rehabilitation program and the LVAD patients discharged home regarding demographics, comorbidities, and outcomes is shown
in Table 4. The patients in both groups were similar except for age, insulin use, and the prevalence of renal failure (Table 4). This study’s follow-up data showed that 10.6% of the patients admitted to inpatient rehabilitation program underwent post-LVAD heart transplantation, compared with 37.8% of the patients discharged home.
FIM Scores at Admission and Discharge from Inpatient Rehabilitation Unit The LVAD patients stayed in the inpatient rehabilitation program for a mean (SD) of 6.6 (3.9) days (between 1 and 16 days). The patients admitted to inpatient rehabilitation had their functional status evaluated during the admission and discharge assessment periods using the FIM instrument. Analysis of both measurements showed a significant improvement in all of the functional and cognitive items at discharge compared with their status at the time of admission, except for bowel control, which changed at
FIGURE 3 Changes in FIM scores of LVAD patients between admission to and discharge from inpatient rehabilitation program. A, The x-axis represents the physical and cognitive items that are assessed for patients in inpatient rehabilitation program. The y-axis represents the FIM score. For each item, FIM score is represented both at admission (purple) and discharge (red). Asterisk represents significant differences (P G 0.0001). B, FIM wheel displays each item of the 18 FIM components represented as a line from the center of the wheel and divided from 1 to 7 (scores). Admission and discharge FIM scores for a specific item are represented by two dots on the line belonging to that item. The gray areas represent the improvement in FIM scores of LVAD patients between admission to and discharge from inpatient rehabilitation program. Significant improvement was achieved in most of the cognitive and physical domains in LVAD patients completing an inpatient rehabilitation program. www.ajpmr.com
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FIGURE 4 Change in total FIM score of LVAD patients admitted to inpatient rehabilitation program. On the x-axis is the mean value of discharge and admission total FIM. On the y-axis is the difference between the discharge and admission FIM scores. Each dot represents an individual patient in the study. The solid red horizontal line represents the mean FIM change, and the two dotted red horizontal lines represent the confidence intervals for the population. FIM change in relation to the admission FIM score demonstrates that virtually most patients admitted to inpatient rehabilitation experience a positive change in their functional status, and the amount of change is only slightly related to the admission FIM score.
discharge, but not significantly (P = 0.25; Figs. 3A, B). When comparing the total score at admission and discharge, total FIM score improved significantly (77.1 vs. 95.2; P G 0.0001; Fig. 4).
DISCUSSION The main finding in this retrospective descriptive study is that the patients with LVAD had significant improvements in their functional status after a relatively short stay in the inpatient rehabilitation program. The present study is of importance considering the increasing numbers of HF patients receiving LVADs as both destination and bridge therapy and the fact that the postoperative care of these patients is complex because of multiple medical issues associated with chronic and debilitating diseases. Therefore, a multidisciplinary approach involving cardiovascular surgeons, cardiovascular physicians, and other healthcare professionals should be considered to minimize morbidity and improve the quality-of-life in these patients. Consequently, the role of physiatrists, therapists, and rehabilitation nurses, in a hospital-based setting, could be essential in the postsurgical care of these patients. Fifty percent of the patients in this study’s population were admitted to the authors’ inpatient rehabilitation unit. As expected, on the basis of the
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design of the authors’ program, older individuals and those with greater medical complexity (renal failure, diabetes, destination LVAD therapy) were more likely to require admission to inpatient rehabilitation. This study shows the positive impact of the inpatient rehabilitation program on 17 functional and cognitive skills of the 18 items measured by the FIM instrument. In addition, the data of this study demonstrated a significant improvement in the total FIM score in agreement with the available literature. Nissinoff and colleagues21 reported three cases of patients admitted to inpatient rehabilitation after LVAD implantation, in which FIM score improved from 76, 66, and 67 at admission to 108, 84, and 98, respectively, at discharge. Nguyen and Stein22 studied 11 patients who underwent LVAD placement and required inpatient rehabilitation. These patients stayed for 17.5 (8.9) days and achieved a mean FIM gain of 28.6. Similarly, English and Speed23 found in 20 of LVAD patients that mean total FIM score improved by 22.05 after 11.6 days in the inpatient rehabilitation unit. Despite the medical complexity in the group of patients admitted to inpatient rehabilitation, FIM scores for both cognitive and physical function significantly improved during the rehabilitation program. Previous studies have shown that a high FIM score at discharge from inpatient rehabilitation programs is a predictor of quality-of-life and survival in specific
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populations, suggesting that this may also be the case in LVAD patients.15,24Y26 However, studies evaluating long-term outcomes of patients participating in rehabilitation after LVAD therapy need to be explored in the future. This study had certain limitations that should be noted. This was a retrospective analysis of medical records, thus limiting data analysis to variables that were available to the authors. Moreover, the numbers of participants in this study are modest, not allowing the authors to do subgroup analyses with good statistical power. The functional improvement noted in this study may be attributed in part to the effect of LVAD itself. Because FIM score is used only during inpatient rehabilitation, the authors do not know the level of activity in the patients who were discharged home directly from the acute setting, and they could not compare the improvement in physical activity with those patients as a control group of the LVAD patients who were not admitted to inpatient rehabilitation. In addition, this study included data from one inpatient rehabilitation program with limited ethnic diversity; therefore, these findings may not be generalized to other programs.
CONCLUSIONS Approximately half of the patients receiving LVAD therapy in this study cohort required inpatient rehabilitation before discharge to home. Older patients, those who require LVAD implantation as destination therapy, and those with greater medical complexity such as renal failure and diabetes were more likely to require inpatient rehabilitation. Individuals who undergo an LVAD implantation followed by inpatient rehabilitation have a significant improvement in functional and cognitive status. Therefore, involvement of therapy services and participation in inpatient rehabilitation programs should be strongly considered in patients receiving LVAD. REFERENCES 1. Ferris H, Hunt S: Destination ventricular assist devices for heart failure #205. J Palliat Med 2009;12: 956Y7 2. Daneshmand MA, Rajagopal K, Lima B, et al: Left ventricular assist device destination therapy versus extended criteria cardiac transplant. Ann Thorac Surg 2010;89:1205Y9; discussion 1210 3. Rose EA, Gelijns AC, Moskowitz AJ, et al, for the REMATCH Study Group: Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med 2001;345:1435Y43 www.ajpmr.com
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