Second INTERMACS annual report: More than 1,000 primary left ventricular assist device implants

Abstract

The Interagency Registry For Mechanical Circulatory Support (INTERMACS),1Kirklin J.K. Naftel D.C. Stevenson L.W. Kormos R.L. Pagani F.D. Miller M.A. Ulisney K. Young J.B. INTERMACS: database for durable devices for circulatory support: first annual report.J Heart Lung Transplant. 2008; 27 (1065-72): 10Abstract Full Text Full Text PDF Scopus (270) Google Scholar a National Heart, Lung, and Blood Institute (NHLBI)-sponsored collaboration between the NHLBI, the United States (U.S.) Food and Drug Administration (FDA), the Center for Medicaid and Medicare Services (CMS), and the advanced heart failure/mechanical circulatory support professional community, began prospective patient enrollment and data collection on June 23, 2006. On March 27, 2009, CMS mandated that all U.S. hospitals approved for mechanical circulatory support as destination therapy (DT) enter mechanical circulatory support patient data into a national database, INTERMACS. The power of INTERMACS data stems from the mandatory data submission on all durable mechanical circulatory devices, a formal process for adverse event adjudication, dedicated innovative electronic data submission, data element design to create a template for comparison with medical therapy, rigorous data monitoring, hospital auditing through the United Network of Organ Sharing, and a formal process for data access and publications. Since the inception of INTERMACS, an ongoing evolution of both strategies for device application and the types of available devices has continued to refine the landscape of mechanical circulatory support. Throughout this experience, the only device approved in the United States for permanent DT was the HeartMate XVE (Thoratec, Pleasanton, CA),2Rose E.A. Moskowitz A.J. Packer M. et al.The REMATCH trial: rationale, design, and end points Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure.Ann Thorac Surg. 1999; 67: 723-730Abstract Full Text Full Text PDF PubMed Scopus (294) Google Scholar a pulsatile ventricular assist device that is now known to frequently develop bearing wear and require device replacement within 2 years of implantation. Yet, in many countries outside the United States, newer axial flow and centrifugal flow rotary pumps provide long-term circulatory support. INTERMACS only collects data on devices that are FDA-approved for clinical use, and no adult rotary pump was approved in the United States for the first several years of the INTERMACS experience. The spectrum of devices entered into INTERMACS must also be viewed in the context of multiple concurrent U.S. clinical trials of continuous flow pumps implanted as bridge-to-transplant (BTT) therapy as well as permanent support. Thus, for the first 2 years, despite the rigorous requirements for data completeness and accuracy, INTERMACS was hampered by an inability to collect data on newer, more promising rotary pumps that were not yet FDA-approved. The INTERMACS playing field changed dramatically in April 2008 when the HeartMate II axial flow pump (Thoratec) received FDA approval for clinical use as BTT therapy in the United States. A portion of this report will examine the changing practice patterns in the application of device type (continuous flow vs pulsatile) and device strategies during the past 3 years. In fact, the genesis of INTERMACS, partly by chance and partly by design, uniquely positioned this database to observe, record, and analyze this historical transition—at least for the immediate future—from larger, powerful pulsatile pumps to the world of continuous flow technology, with the unproven promise of greater durability while retaining long-term patient functionality. This report begins the process of long-term evaluation of continuous flow technology against the background of a large registry of detailed patient and device data based on pulsatile pump technology. Between June 23, 2006, and March 31, 2009, 88 institutions (Appendix 1) entered 1,420 patients into the INTERMACS database. Mean follow-up for survivors has been 6 months (range, 1 day to 2.9 months). This report will focus on the 1,092 patients who received primary left ventricular assist device (LVAD) implants among the total of 1,420 patients who received primary and secondary devices (Table 1). The FDA-approved devices included in the INTERMACS registry are listed in Appendix 2. The general patient demographics were similar for all patients and the primary LVAD group (Table 2).Table 1Prospective Patients (N = 1420) Who Received Primary and Secondary Devices (INTERMACS: June 2006–March 2009)Device sidePrimaryNot primaryTotalLVAD1092661158RVAD31518Bi-VAD17914193TAH50151Total132496aOf the 96 not primary implants, 40 (42%) have their primary implant entered into Interagency Registry For Mechanical Circulatory Support (INTERMACS).1420Bi-VAD, biventricular assist device; LVAD, left ventricular assist device; RVAD, right ventricular assist device; TAH, total artificial heart.a Of the 96 not primary implants, 40 (42%) have their primary implant entered into Interagency Registry For Mechanical Circulatory Support (INTERMACS). Open table in a new tab Table 2Demographics for Prospective Patients (INTERMACS: June 2006–March 2009)VariableAll implantsPrimary LVAD(N = 1420)(n = 1092)Gender, No. (%) Males1107 (78)865 (79) Females313 (22)227 (21%)Race, No. (%) White1004 (71)763 (70) African American301 (21)247 (23) Other115 (8)82 (7)Age at implant Mean years51.352.3 Range4.5–79.94.5–79.9 <19 years, No. (%)37 (3)22 (2)INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device. Open table in a new tab Bi-VAD, biventricular assist device; LVAD, left ventricular assist device; RVAD, right ventricular assist device; TAH, total artificial heart. INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device. The 1,092 primary LVAD implants were approximately 48% pulsatile and 52% continuous flow pumps (Table 3). At the time of implant, 85% of patients were in INTERMACS level 1 or 2 or 3, and less than 5% were higher than level 4 (Table 4).3Warner-Stevenson L. Kirklin J.K. Pagani F.D. et al.INTERMACS Profiles of Advanced Heart Failure: First Definition.J Heart Lung Transp. 2009; 28: 535-541Abstract Full Text Full Text PDF PubMed Scopus (478) Google Scholar The spectrum of INTERMACS levels has changed during the course of the study; the proportion of level 1 has decreased from 38% during the first half of the study to 27% during the second half. This likely reflects a recognition of the higher early mortality associated with implementation of mechanical circulatory support in the throes of cardiogenic shock1Kirklin J.K. Naftel D.C. Stevenson L.W. Kormos R.L. Pagani F.D. Miller M.A. Ulisney K. Young J.B. INTERMACS: database for durable devices for circulatory support: first annual report.J Heart Lung Transplant. 2008; 27 (1065-72): 10Abstract Full Text Full Text PDF Scopus (270) Google Scholar (see Survival).Table 3Type of Primary Left Ventricular Assist Device (INTERMACS: June 2006–March 2009)TypeNo.%(N = 1092)Pulsatile52848.4 Intracorporeal46042.1 Paracorporeal686.2Continuous flow56451.6Total1092100.0INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device. Open table in a new tab Table 4INTERMACS Level at Implant for 1092 Primary LVAD (June 2006–March 2009)INTERMACS level (pre-implant)Primary LVAD (N = 1092)No.%1. Critical cardiogenic shock32830.02. Progressive decline43740.03. Stable but inotrope dependent16815.44. Recurrent advanced HF1069.75. Exertion intolerant211.96. Exertion limited121.17. Advanced NYHA III201.8Total1092100.0HF, heart failure; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device; NYHA, New York Heart Association. Open table in a new tab INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device. HF, heart failure; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device; NYHA, New York Heart Association. The distribution of pre-implant device strategies continues to focus on supporting patients to cardiac transplantation as bridge to candidacy (BTC) or BTT (Table 5). The initial strategy was permanent (DT) in nearly 10%. The distribution of INTERMACS levels among device strategies is summarized in Table 6.Table 5Device Strategy at Time of Implant of Primary LVAD (INTERMACS: June 2006–March 2009)Pre-implant device strategyNo.%(N = 1092)Bridge to transplant (currently listed)49645.4Bridge to candidacy45841.9 Listing likely30527.9 Listing moderately likely1009.2 Listing unlikely534.9Planned DT (permanent device)1009.2Bridge to recovery252.3Rescue therapy100.9Other30.3Total1092100.0DT, destination therapy; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device. Open table in a new tab Table 6INTERMACS Level and Device Strategy (June 2006–March 2009)INTERMACS levelBTTBTCDTBTRRTOtherTotal(pre-implant)No.No.No.No.No.No.No.1. Critical cardiogenic shock1201622116813282. Progressive decline217173395214373. Stable but inotrope dep.8558231011684. Recurrent advanced HF4150123001065. Exertion intolerant1191000216. Exertion limited552000127. Advanced NYHA class III171200020Total496458100251031092BTC, bridge to candidacy; BTT, bridge to transplant; DT, destination therapy; HF, heart failure; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device; NYHA, New York Heart Association; RT, rescue therapy. Open table in a new tab DT, destination therapy; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device. BTC, bridge to candidacy; BTT, bridge to transplant; DT, destination therapy; HF, heart failure; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device; NYHA, New York Heart Association; RT, rescue therapy. The superior survival of LVAD patients compared with survival with device types and combinations in this database is reflected in Figure 1. The focus of this report is the actuarial survival of the primary LVAD cohort, which was 83% at 6 months, 74% at 1 year, and 55% at 2 years (Figure 2).Figure 2Actuarial and parametric survival is shown for the 1,092 patients undergoing primary left ventricular assist device (LVAD) implant. Patients are censored at transplant or device explant for recovery. The dashed lines represent the 70% confidence limits. The hazard function (instantaneous risk of death) is depicted by the lower curve.View Large Image Figure ViewerDownload Hi-res image Download (PPT) The survival stratified by INTERMACS levels shows early increased death for patients in level 1 at the time of device implant (Figure 3). When stratified by device strategy, BTT patients had superior survival (Figure 4). In contrast with BTT and BTC cohorts, nearly all of the DT implants were pulsatile pumps, which does not reflect the more recent continuous flow technology (see later sections). Interpretation of these actuarial curves is further confounded by the censoring at transplantation, which is heavily weighted toward the BTT group. As shown in the competing outcomes analysis, 52% of BTT patients had undergone transplantation at 1 year (Figure 5) compared with 35% in the BTC group (Figure 6) and only 10% in DT patients (Figure 7).Figure 4Actuarial survival is shown stratified by device strategy at time of implant. The depiction is as in Figure 1. BTC, bridge to candidacy; BTT, bridge to transplantation; DT, destination therapy; LVAD, left ventricular assist device.View Large Image Figure ViewerDownload Hi-res image Download (PPT)Figure 5Competing outcomes are shown for primary left ventricular assist devices (LVAD) with bridge to transplant (BTT) as the strategy at the time of implant. At any time point in the follow-up, the sum of the percentages of all outcomes equals 100%.View Large Image Figure ViewerDownload Hi-res image Download (PPT)Figure 6Competing outcomes analyses are shown for primary left ventricular assist device (LVAD) patients with bridge to candidacy (BTC) as the initial strategy at the time of implant. The depiction is as in Figure 5.View Large Image Figure ViewerDownload Hi-res image Download (PPT)Figure 7Primary left ventricular assist device (LVAD) patients with destination therapy (DT) as the initial strategy at time of implant. The depiction is as in Figure 5.View Large Image Figure ViewerDownload Hi-res image Download (PPT) The primary causes of death for patients receiving primary LVAD implants are listed in Table 7. The major causes of death differed somewhat according to device strategy: central nervous system events accounted for nearly twice the proportion of deaths among DT patients as for BTT or BTC patients (Table 8). The reasons for this difference are not yet apparent.Table 7Causes of Death in 1092 Primary LVAD Patients (INTERMACS: June 2006–March 2009)Primary cause of deathEarly (≤1 mon)Later (>1 mon)Total(n = 69)(n = 122)(N = 191)No.%No.%No.%Cardiac failureaCardiac failure includes right ventricular failure and ventricular tachycardia/ventricular fibrillation.2130.42117.24222.0Infection68.72520.53116.2CNS event811.61915.62714.1Multiorgan failure1115.997.42010.5Respiratory failure45.864.9105.2Bleeding Bleeding11.443.352.6 Gastrointestinal00.021.621.0 Surgical57.210.863.1Device failure00.097.494.7Renal failure34.332.563.1Hepatic failure22.910.831.6Malignancy00.021.621.0Arterial embolism00.010.810.5Cardiac tamponade11.400.010.5Post-explant failure to recover00.010.810.5Other710.11814.82513.1Total69100.0122100.0191100.0CNS, central nervous system; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device.a Cardiac failure includes right ventricular failure and ventricular tachycardia/ventricular fibrillation. Open table in a new tab Table 8Five Leading Causes of Death by Device Strategy in 1092 Primary LVADs (INTERMACS: June 2006–March 2009)Primary cause of deathBTT (n = 54)BTC (n = 92)DT (n = 39)Total (N = 191)No.%No.%No.%No.%Cardiac failureaCardiac failure includes right ventricular failure and ventricular tachycardia/ventricular fibrillation.1222.22021.7923.14121.5Infection712.91617.4615.42915.2CNS event611.11213.0923.12714.1Multiorgan failure59.31213.037.7200.5Respiratory failure35.666.512.5105.2All other causes2138.92628.31128.264bSix deaths are BTR (n = 2) and rescue therapy (n = 4).33.5Total54100.092100.039100.0191100.0BTC, bridge to candidacy; BTR, bridge to recovery; BTT, bridge to transplant; CNS, central nervous system; DT, destination therapy; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device.a Cardiac failure includes right ventricular failure and ventricular tachycardia/ventricular fibrillation.b Six deaths are BTR (n = 2) and rescue therapy (n = 4). Open table in a new tab CNS, central nervous system; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device. BTC, bridge to candidacy; BTR, bridge to recovery; BTT, bridge to transplant; CNS, central nervous system; DT, destination therapy; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device. By multivariable analysis, (see Appendix 3 for list of variables examined), risk factors reflecting older age, greater severity of right ventricular failure, and cardiogenic shock at implant predict a higher likelihood of early death among all LVAD patients (Table 9). It is of interest that the use of a pulsatile pump was a risk factor for death in the constant phase. Whether pump-related complications or malfunction account for this risk factor will require further analyses. Among the smaller group of DT patients (essentially all of whom received a pulsatile pump), older age was the only identifiable risk factor for death (Table 10).Table 9Risk Factors for Death after Implant in 1092 Primary LVADs (INTERMACS: June 2006–March 2009)Risk factorEarlyConstantHRp-valueHRp-valueAge (older)2.42aHazard ratio denotes the increased risk from age 60 to 70 years.<0.00011.55aHazard ratio denotes the increased risk from age 60 to 70 years.0.0005Bilirubin (higher)1.41bHazard ratio denotes the increased risk of a 2-unit increase in bilirubin.0.0002……RA pressure (higher)2.08cHazard ratio denotes the increased risk of a 10-unit increase in RA pressure.0.0009……Cardiogenic shock1.970.02……BTC or DT……1.800.02Pulsatile pump……2.740.001BTC, bridge to candidacy; BTT, bridge to transplant; DT, destination therapy; HR, hazard ratio; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device; RA, right arterial.a Hazard ratio denotes the increased risk from age 60 to 70 years.b Hazard ratio denotes the increased risk of a 2-unit increase in bilirubin.c Hazard ratio denotes the increased risk of a 10-unit increase in RA pressure. Open table in a new tab Table 10Risk Factors for Death After Primary 100 LVAD Implants as Destination Therapy (INTERMACS: June 2006–March 2009)Risk factorEarlyConstantHRp-valueHRp-valueAge (older)2.76aHazard ratio denotes the increased risk from age 60 to 70 years.0.03……HR, hazard ratio; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device.a Hazard ratio denotes the increased risk from age 60 to 70 years. Open table in a new tab BTC, bridge to candidacy; BTT, bridge to transplant; DT, destination therapy; HR, hazard ratio; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device; RA, right arterial. HR, hazard ratio; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device. During the first 2 years of INTERMACS, few pulsatile pumps were entered into the registry. With the first FDA approval of a continuous flow pump for adults as BTT support in April 2008, these pumps became available for entry into INTERMACS. Patient accrual before and after approval of an adult continuous flow pump shows a dramatic change in favor of continuous flow devices (Figure 8). The preference for continuous flow technology as BTT therapy (currently no continuous flow pump is approved for DT) is reflected in the depiction indicating that more than 85% of primary LVADs implanted between July 2008 and January 1, 2009, were continuous flow pumps. The survival advantage to date with continuous flow pumps (BTC or BTT) is apparent in Figure 9.Figure 9Actuarial survival is shown after primary left ventricular assist device (LVAD) implant with an initial strategy of bridge to transplant (BTT) or bridge to candidacy (BTC), stratified by pulsatile vs continuous flow pumps. The depiction is as in Figure 1.View Large Image Figure ViewerDownload Hi-res image Download (PPT) The profile of adverse events among primary LVAD patients is listed in Table 11. Because continuous flow pumps have only accrued a mean follow-up of 4.6 months, Table 12 compares adverse events among pulsatile vs continuous flow pumps during the first 6 months after implantation. Infection and bleeding remain the most common adverse events in the LVAD population in the first year after implant. In the BTT and BTC groups, the adverse events are different for the continuous vs pulsatile pumps. In general, the events per 100 patient-months are importantly reduced in patients with continuous flow devices for device malfunction, infection, hepatic dysfunction, and neurologic events.Table 11Adverse Events Rates (Events/100 Patient-Months) in First 12 Months After Implant for 1092 Primary LVADs (INTERMACS: June 2006–March 2009)Adverse eventEventsRateDevice malfunction1131.98Bleeding94416.52Cardiac/vascular Right heart failure1081.89 Myocardial infarction40.07 Cardiac arrhythmia4397.68 Pericardial drainage861.50 HypertensionaWith current reporting, identification of hypertension with continuous flow pumps is unreliable.1322.31 Arterial non-CNS thrombosis200.35 Venous thrombotic event831.45 Hemolysis310.54Infection99817.46Neurologic dysfunction1642.87Renal dysfunction1422.48Hepatic dysfunction520.91Respiratory failure2574.50Wound dehiscence270.47Psychiatric episode1121.96Total “burden”371264.96CNS, central nervous system; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device.Unajudicated data.a With current reporting, identification of hypertension with continuous flow pumps is unreliable. Open table in a new tab Table 12Adverse Event Rates (Events/100 Patient Months) in the First 12 Months Post-implant for Primary LVADs for 954 BTT and BTC (INTERMACS: June 2006–March 2009)Adverse eventPulsatile (n = 406)Continuous (n = 548)Pulsatile/continuousEventsRateEventsRateRatiop-valueDevice malfunction452.95170.823.60<0.0001Bleeding36924.2236017.411.39<0.0001Cardiac/vascular Right heart failure483.15462.231.410.05 Myocardial infarction20.1320.101.300.37 Cardiac arrhythmia15410.1121810.540.960.65 Pericardial drainage442.89301.451.990.003 HypertensionaWith current reporting, identification of hypertension with continuous flow pumps is unreliable.754.92170.826.00<0.0001 Arterial non-CNS thrombosis70.4660.291.590.21 Venous thrombotic event382.49321.551.610.03 Hemolysis110.72120.581.240.29Infection43128.2924411.802.40<0.0001Neurologic dysfunction664.33401.932.24<0.0001Renal dysfunction634.14452.181.900.0007Hepatic dysfunction241.58140.682.320.009Respiratory failure1217.94894.311.84<0.0001Wound dehiscence80.5390.441.200.34Psychiatric episode432.82381.841.530.03Total burden1549101.69121958.961.72<0.0001BTC, bridge to candidacy; BTT, bridge to transplant; CNS, central nervous system; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device.a With current reporting, identification of hypertension with continuous flow pumps is unreliable. Open table in a new tab CNS, central nervous system; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device. Unajudicated data. BTC, bridge to candidacy; BTT, bridge to transplant; CNS, central nervous system; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device. The frequency with which patients are diverted from their original strategy was documented in the first annual INTERMACS report.1Kirklin J.K. Naftel D.C. Stevenson L.W. Kormos R.L. Pagani F.D. Miller M.A. Ulisney K. Young J.B. INTERMACS: database for durable devices for circulatory support: first annual report.J Heart Lung Transplant. 2008; 27 (1065-72): 10Abstract Full Text Full Text PDF Scopus (270) Google Scholar Coincident with the availability of a continuous flow pump for BTT in adults in April 2008, a marked shift occurred away from a primary strategy of DT among patients entered into the registry (Table 13). The dramatic increase in the number of patients entered into the database with a primary strategy of BTT or BTC beginning in the second quarter of 2008 (Table 13) further underscores the seeming lack of clear distinction between primary device strategies. Close observation of these trends after FDA approval of a continuous flow device for DT will shed further insights into clinical practice.Table 13Patient Accrual in INTERMACS (June 2006–March 2009) for 1420 Primary LVADSaDoes not include bridge to recovery (n = 42), rescue therapy (n = 14), and other (n = 6) patients.Implant yearBTTBTCDTTotalNo (%)No (%)No. (%)No. (%)200647 (42.0)44 (39.2)21 (18.8)112 (100)2007161 (45.6)139 (39.4)53 (15.0)353 (100)2008bAxial flow pump approved in April 2008.359 (51.5)297 (42.6)41 (5.9)697 (100)2009 (Qtr 1)100 (51.0)92 (47.0)4 (2.0)196 (100)Total667 (49.0)572 (42.0)119 (9.0)1358 (100)BTC, bridge-to-candidacy; BTT, bridge-to-transplant; DT, destination therapy; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device.a Does not include bridge to recovery (n = 42), rescue therapy (n = 14), and other (n = 6) patients.b Axial flow pump approved in April 2008. Open table in a new tab BTC, bridge-to-candidacy; BTT, bridge-to-transplant; DT, destination therapy; INTERMACS, Interagency Registry For Mechanical Circulatory Support; LVAD, left ventricular assist device. Although INTERMACS requires strict adherence to data submission, identification of adverse events, and complete patient follow-up, the registry does not directly mandate specific clinical protocols for frequencies of routine patient visits, laboratory tests to be obtained, or functional outcomes and quality of life tests to be administered. However, INTERMACS does require that if any such tests are obtained, the results must be entered. The divergence in clinical practice for routine chemistries rather than periodic functional and quality of life testing is apparent in our follow-up data (Table 14). A review of routine blood chemistries collected at periodic intervals showed the rate of complete data submission was very high. In contrast, quality of life as measured by the EuroQol, cognitive function as measured by the Trailmaking Test, and functional outcome measured by the 6-minute walk test have been reported with a much lower frequency (Table 14).Table 14Follow-up Data for Adult Prospective Implants Presented at INTERMACS Third Annual Meeting, March 2009, OrlandoPre-implantFollow-up visitsaThe total possible follow-up visits at 3, 6 and 12 months is 878 among survivors.MeasurementNo.% of 957aThe total possible follow-up visits at 3, 6 and 12 months is 878 among survivors.No.% of 878Creatinine95399.665674.7Bilirubin87291.147954.6INR90294.247654.2NYHA86790.653560.9EuroQoL32333.834939.7Trailmaking Test25526.630835.16-min walk303.113315.1VO2 Max586.1252.8EuroQol, European Quality of Life assessment; INTERMACS, Interagency Registry For Mechanical Circulatory Support; INR, international normalized ratio; NYHA, New York Heart Association; VO2, oxygen consumption.a The total possible follow-up visits at 3, 6 and 12 months is 878 among survivors. Open table in a new tab EuroQol, European Quality of Life assessment; INTERMACS, Interagency Registry For Mechanical Circulatory Support; INR, international normalized ratio; NYHA, New York Heart Association; VO2, oxygen consumption. Review of this issue at the recent annual INTERMACS meeting (March 27, 2009, Orlando, FL) revealed that these 3 simple tests—EuroQol, Trailmaking, and 6-minute walk—are not a routine part of the follow-up in many mechanical circulatory support centers. This deficiency has important implications as we attempt to collect data that will further define the benefits of this therapy compared with medical treatment or other strategies for patients with advanced New York Heart Association class III and IV heart failure. Future recommendations on the advisability of this expensive and invasive therapy will depend not only on survival advantage and freedom from adverse events but also, importantly, on the patient's expected functionality, cognitive recovery, and quality of life with long-term mechanical circulatory support. To address the problem of incomplete assessment of functional outcome and quality of life after device implant, a group of experts representing the International Society for Heart and Lung Transplantation, including experts from INTERMACS, has been convened to develop a consensus recommendation for the follow-up of mechanical circulatory support patients, focusing on functional evaluation, cognitive assessment, and quality of life measures. INTERMACS has analyzed the first 1000-plus patients with primary implantation of LVADs during a transitional period from pulsatile technology to continuous flow pumps. The shift toward implantation of axial flow technology since its approval by FDA is dramatic. This trend has been accompanied by continued fluctuation in the designation of primary device strategy as BTT, BTC, and DT. Inferences from this database regarding expected midterm survival with device therapy must be interpreted with this understanding. When continuous flow technology is routinely available for long-term DT, and as multiple continuous flow pumps are approved, INTERMACS offers a unique opportunity to compare and contrast these technologies in the setting of evolving indications, changing patient profiles, and refinement of device strategy in the developing landscape of mechanical circulatory support. This work was sponsored by the National Institutes of Health, National Heart, Lung and Blood Institute (NHLBI), Registry of Mechanical Circulatory Support Devices for End-Stage Heart Failure (INTERMACS). Contract No. HHSN268200548198C. None of the authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose. Appendix 1Institutions That Have Contributed DataAdvocate Christ Medical CenterAllegheny General HospitalBaptist Health Medical CenterBaptist Memorial Hospital—MemphisBarnes-Jewish HospitalBaylor University Medical CenterBrigham and Women's HospitalBryan LGH Medical CenterCalifornia Pacific Medical CenterCarolinas Medical CenterCedars Sinai Medical CenterChildren's Healthcare of AtlantaChildren's Medical CenterCleveland ClinicColumbia Presbyterian–Children's Hospital of New YorkColumbia University Medical Center–New York PresbyterianDuke University Medical CenterEmory University HospitalHahnemann University HospitalHenry Ford HospitalHospital of the University of PennsylvaniaInland Northwest Thoracic Organ Transplant Program, Sacred Heart MedicalInova Fairfax HospitalINTEGRIS Baptist Medical CenterIntermountain Medical Center (formerly LDS Hospital)Jackson Memorial Health System/University of MiamiJewish HospitalLancaster General HospitalLankenau HospitalLutheran Hospital of IndianaMaine Medical CenterMassachusetts General HospitalMayo Clinic HospitalMayo Clinic JacksonvilleMedical City Dallas HospitalMethodist HospitalMethodist Specialty and Transplant HospitalMid America Heart Institute of Saint Luke's HospitalMontefiore Medical CenterMorristown Memorial Hospital–Atlantic HealthMount Sinai MedicalNewark Beth Israel Medical CenterNorthwestern Memorial HospitalOchsner Medical CenterOregon Health & Science UniversityOSF St Francis Medical CenterPenn State Milton S. Hershey Medical CenterRobert Wood Johnson University HospitalRush University Medical CenterSaint Marys/Mayo ClinicSentara Norfolk General HospitalSeton Medical CenterShands at the University of FloridaSharp Memorial HospitalSt. Louis Children's HospitalSt. Luke's Episcopal Hospital/Texas Heart InstituteSt. Luke's Medical CenterSt. Vincent Hospital and Health Care CenterSutter Memorial HospitalTampa General HospitalTemple University HospitalTexas Children's HospitalThe Johns Hopkins HospitalThe Methodist HospitalThe Ohio State University Medical CenterThomas Jefferson UniversityTufts Medical CenterUniversity Health CareUniversity Hospitals Case Medical CenterUniversity of Alabama at Birmingham HospitalUniversity of Arizona Medical CenterUniversity of California–Los Angeles Medical CenterUniversity of Chicago HospitalsUniversity of Colorado HospitalUniversity of Iowa Hospitals and ClinicsUniversity of Maryland Medical CenterUniversity of Michigan Health SystemsUniversity of Minnesota Medical Center-FairviewUniversity of North Carolina HospitalsUniversity of Pittsburgh Medical CenterUniversity of Rochester Medical Center (Strong Memorial Hospital)University of Texas Southwestern Medical CenterUniversity of Virginia Health SystemUniversity of Wisconsin Hospital and ClinicsVirginia Commonwealth University Health SystemWashington Hospital CenterWeill Cornell Medical Center/New York Presbyterian Medical CenterWestchester Medical Center Open table in a new tab Appendix 2Food and Drug Administration-Approved Durable Devices (Potential for Patient Discharge)CompanyDevicePositionAbiomed, IncAbioCor Total Artificial HeartTAHMicromed Technology, IncMicroMed DeBakey Ventricular Assist Device (VAD)—ChildLSynCardia Systems, IncSynCardia CardioWestTAHThoratec CorpHeartMate II Left Ventricular Assist Support (LVAS)LHeartMate Implantable Pneumatic (IP)LHeartMate Vented Electric (VE)LHeartMate Extended Vented Electric (XVE)LThoratec Implantable Ventricular Assist Device (IVAD)L/R Thoratec Paracorporeal Ventricular Assist Device (PVAD)L/RWorldHeart, IncNovaCor PCLNovaCor PCqLL, left ventricle; L/R, left or right ventricle; TAH, total artificial heart. Open table in a new tab L, left ventricle; L/R, left or right ventricle; TAH, total artificial heart. Appendix 3Variables Examined in Risk Factor AnalysisDemographics Age Male White Black Height, cm Weight, kg Body surface area (BSA)Laboratory values Sodium Albumin Bilirubin Blood urea nitrogen (BUN) Creatinine Cholesterol International normalized ratio (INR)Clinical Protein C C-reactive protein (CRP) Blood type Diagnosis—congenital Diagnosis—coronary artery disease History of coronary artery bypass grafting (CABG) History of valve History of mechanical circulatory support devices (MCSD) Implantable cardiac defibrillator (ICD) Inotropes Diabetes Chronic obstructive pulmonary disease (COPD) Ascites Cardiovascular accident Cancer Current smoker Alcohol abuse New York Heart Association (NYHA)Device strategy Bridge to recovery Bridge to transplant listed Bridge to transplant likely listed Bridge to transplant moderately likely Bridge to transplant unlikely Destination therapyHemodynamics Cardiac output Left ventricular end-diastolic diameter (LVEDD) Pulmonary diastolic pressure Pulmonary systolic pressure Pulmonary wedge pressure Right ventricular ejection fraction (RVEF) Right atrial pressure (RAP) Systolic blood pressure Left ventricular ejection fraction <20Patient profile levels Level 1 Level 2 Level 3 Level 4 Level 5 Level 6 Level 7Ventricular tachycardia/ventricular fibrillationImplant information Left ventricular assist device (LVAD) Right ventricular assist device (RVAD) Biventricular assist device (Bi-VAD) Total artificial heart (TAH) Concomitant surgery Left ventricular assist device continuous flow Open table in a new tab