Combined Renal Risk Score Predicts Post-Implant Renal Failure in Continuous-Flow Left Ventricular Assist Device (CF-LVAD) Patients

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The Journal of Heart and Lung Transplantation, Vol 35, No 4S, April 2016 1( 051) Performance of Continuous Flow Left Ventricular Assist Devices for the Smaller Size Patient Population T. Fujita ,1 H. Hata,1 Y. Matsumoto,1 Y. Shimahara,1 O. Seguchi,2 M. Yanase,2 T. Nakatani,2 N. Fukushima,2 J. Kobayashi.1  1Cardiac Surgery, National Cerebral and Cardiovascular Center, Suita, Japan; 2Transplantation, National Cerebral and Cardiovascular Center, Suita, Japan.

1( 050) Does INTERMACS Classification Predict Outcomes after LVAD Implantation? S. Maltais ,1 N.A. Haglund,2 M.E. Davis,2 J. Cowger,3 P. Shah,4 P. Shah,4 F.D. Pagani,5 K.D. Aaronson,5 S.M. Dunlay,6 J.M. Stulak.1  1Cardiovascular Surgery, Mayo Clinic, Rochester, MN; 2Vanderbilt, Nashville, TN; 3St-Vincent Hospital, Rochester, MN; 4Inova Fairfax, Virginia, VA; 5Michigan, Michigan, MI; 6Mayo Clinic, Rochester, MN. Purpose: INTERMACS profiles are used to predict outcomes after continuous-flow left ventricular assist device implantation (CF-LVAD). Reports suggest variability in reporting preoperative INTERMACS category. We performed a multicenter analysis validating the predictive ability of INTERMACS profiles for outcomes. Methods: From May 2004 to May 2015, 997 patients (801 males, median age 59 years) underwent primary CF-LVAD implantation at our institutions. HeartMate II (HMII) was implanted in 744 patients (75%) and HeartWare VAD (HVAD) in 253 (25%). INTERMACS profile was assigned based on the level of illness. Kaplan-Meier curves and multivariable models were used to compare survival and adverse events. Results: INTERMACS profile distribution revealed 57 patients (6%) in profile 1, 247 patients (25%) in 2, 421 (42%) patients in 3, and 272 patients (27%) in 4-7 (p< 0.001). Profile 1 patients were sicker and INTERMACS 3 patients were more likely to be implanted as destination therapy. No difference was observed in device type utilization between profiles. In-hospital mortality was highest in INTERMACS 1 patients (20% vs. 6%, 5%, and 6%, p< 0.001). Unadjusted survival was comparable between profiles (p= 0.12). Survival-free of adverse events (AEs) was further comparable between groups (p= 0.06, Figure 1). Multivariable analysis showed only advanced age (HR= 1.92), creatinine (HR= 1.64) and INTERMACS profile (HR= 0.49) predicted mortality. Interestingly, age predicted gastrointestinal bleeding (HR= 2.30), while only HVAD and ischemic etiology were associated with stroke (HR= 1.53, and HR= 1.55). Conclusion: INTERMACS profile describes appropriately the level of illness and important differences existing between profiles. While this report supports its ability to predict mortality after CF-LVAD, other important objective characteristics should be prioritized when predicting adverse events after implant.

Purpose: Since continuous flow left ventricular assist devices (CF-LVAD) became a standard care for end-stage heart failure patients, it is still a challenge to implant CF-LVAD for smaller size patients. We analyzed mid-term outcomes of these patients. Methods: CF-LVADs were implanted in 73 patients (15 female, 40±13 year-old, 51 dilated cardiomyopathy) for the purpose of bridge to heart transplantation (HTx) (BTT) and implanted devices were HeartMateII in 36, EVAHEART in 17, Jarvik2000 in 10, DuraHeart in 9 and HeartWare in 1.The average body surface are (BSA) was 1.65±0.19 m2 (1.22-2.07). These patients were divided into two groups, standard group (BSA> 1.6m2, n= 43) and small group (BSA≤ 1.6m2, n= 30). Mid-term clinical outcomes and data collected from post-implant echocardiography and catheter examination (obtained from 63 patients) were compared between two groups. Optimal LVAD pump speed was set by clinical parameters including echocardiography. Results: The average support period was 1.7±1.1 years (0.1-4.3). Postimplant catheter data showed no significant difference between two groups in cardiac index (2.9±0.6L/m2 in small group, 2.8±0.5L/m2 in standard group, p= 0.27) and mean pulmonary pressure 14±4 mmHg, 16±6 mmHg, p= 0.10). Echocardiography at 1 month showed left ventricular dimension was significantly reduced in both group and there were no significant difference between two groups (18±15%, 14±17%, p= 0.29). There were no operative deaths and 4 late deaths due to cerebrovascular accident (CVA) in 3 and right heart failure in 1. One- and 2-year survival rate (censored by HTx and recovery) for overall patients were 97% and 95%, respectively, and there were no significant difference between two groups (Log-rank test, p= 0.59). CVA were recorded in 24 patients and 1- and 2-year freedom from CVA were 68% and 62%, respectively, and there were no significant difference between two groups (p= 0.49). Serial echocardiography showed that 1- and 2-year freedom from mild or greater aortic regurgitation were 84% and 63% and there were no significant difference between two groups (p= 0.60). Conclusion: CF-LVAD provided excellent clinical outcomes for small size patients in terms of survival and hemodynamics. There were no significant difference between small size patients and standard size patients. 1( 052) Combined Renal Risk Score Predicts Post-Implant Renal Failure in Continuous-Flow Left Ventricular Assist Device (CF-LVAD) Patients V. Topkara ,1 E. Coromilas,1 A.R. Garan,1 M. Yuzefpolskaya,1 K. Takeda,2 H. Takayama,2 R.C. Li,1 M. Tiburcio,2 K. Ross,2 R.N. Sladen,3 D.M. Mancini,1 Y. Naka,2 J. Radhakrishnan,1 P.C. Colombo.1  1Medicine, Columbia University, New York, NY; 2Surgery, Columbia University, New York, NY; 3Anesthesiology, Columbia University, New York, NY. Purpose: Acute kidney injury failure requiring renal replacement therapy (RRT) effects morbidity and mortality of patients on CF-LVAD support. Currently available MCS guidelines do not offer a decision-making algorithm for CF-LVAD candidates with poor baseline renal function. Methods: We reviewed records of 389 CF-LVAD patients implanted between January 2004 and August 2015 at a large academic institution. We compared preoperative renal function between those who did or did not require postoperative RRT, using serum creatinine (SCr), dipstick proteinuria, urine proteincreatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR) by the MDRD equation. Patients were categorized based on requirement for RRT following CF-LVAD implantation. ROC curve analysis was performed to define appropriate cut-offs for significant risk factors. Results: Overall, 44 CF-LVAD patients (11.6%) required post-implant RRT. Patients requiring RRT had significantly worse preoperative renal function than those who did not, as indicated by mean SCr (2.2 vs. 1.4 mg/dL, p< 0.05)

Abstracts S377 and mean UPCR (1.33 vs. 0.32, p< 0.05). Low eGFR-MDRD (less than 40 mL/min/1.73 m2, OR 10.6, p< 0.001) and elevated UPCR (greater than 0.55, OR 8.76, p< 0.001) were independent predictors of RRT, as was dipstick proteinuria (greater than 2+ proteinuria, OR 8.09, p< 0.001). We created a combined VAD renal risk score (CVRRS), where 2 =  low eGFR + elevated UPCR; 1 =  low eGFR or elevated UPCR; and 0 =  normal eGFR and UPCR. The risk of postoperative RRT was significantly greater with a CVRRS of 2 (63.6%), compared with a CVRRS of 1 (19.6%) and CVRRS of 0 (2.2%), (p< 0.001, Fig. 1A). CVRRS provided better discrimination for prediction of need for RRT than eGFR or UPCR alone (Fig. 1B). Conclusion: A CVRRS of 2 (low eGFR + elevated UPCR) is a significant predictor of RRT requirement after CF-LVAD implantation. We recommend its routine preoperative assessment in CF-LVAD candidates to guide expectations and decision-making.

1( 053) No Distance Is Too Great: A Patient’s Commute to Their Implantation Center Is Not Associated with Worse Outcomes Following Placement of a Left Ventricular Assist Device M. Andrews ,1 S. Wesner,1 R. Watkins,1 J.N. Katz.2  1Transplantion, Univ of North Carolina, Chapel Hill, NC; 2Cardiology, Univ of North Carolina, Chapel Hill, NC. Purpose: In the transplant literature, there is conflicting data as to whether or not distance from a patient’s home to their transplant center is associated with poor outcomes. While this has not been directly addressed in patients with a left ventricular assist device (LVAD), it is nonetheless a major reason why some advocate for shared-care partnerships in geographically diverse communities. Our study addresses the relationship between patient-to-implant center (PIC) distance and outcomes in those with a durable HeartMate II LVAD. Methods: Data from consecutive implants (2008-2014) at our center a state-run, university-based hospital without any active shared-care partnerships - were reviewed. Those with at least 1-year follow-up (n= 120) were included. Baseline characteristics, implant designation, heart failure etiology, and INTERMACS profile were collected, and PIC distance was calculated for each patient. The primary endpoint was a composite of 1yr death, stroke, or pump thrombosis. One-year mortality was also evaluated. Descriptive statistics were used and multivariable models constructed for the aforementioned outcomes. Results: Seventy-eight percent of patients were male, 61% white, 54% ischemic, and 68% were destination therapy (DT). The median PIC distance was 61.6 miles, with a range of 3.5-269 miles. A total of 28 patients (23%) died within 1 year of implant and 40 (33%) reached the primary composite endpoint. In the unadjusted setting, only lower INTERMACS profile was significantly associated with the primary composite endpoint, while ischemic etiology (p= 0.04) and lower INTERMACS profile (p= 0.03) were both associated with death. There was no significant relationship between PIC distance and either of the endpoints, and this remained true even when forcing this variable into our multivariable models. Conclusion: In our study population, distance from a patient’s home to our implantation site was not associated with increased risk for death or thrombotic events. Particularly for those centers with a geographically diverse referral pool, like ours, PIC distance alone should not influence patient selection for LVAD and may not be a primary reason to establish shared-care partnerships.

1( 054) Impact of Preoperative Glycemic Control on Long-Term Mechanical Circulatory Support Device Implantation E.A. Downs ,1 L.E. Johnston,1 D.J. LaPar,1 L.T. Yarboro,1 J.A. Kern,1 J.L. Kirby,2 S. Mazimba,2 A.M. Speir,3 J.B. Rich,4 M.A. Quader,5 G. Ailawadi,1 J.L. Kennedy.2  1Surgery, University of Virginia, Charlottesville, VA; 2Medicine, University of Virginia, Charlottesville, VA; 3Cardiovascular and Thoracic Associates, Inova Heart and Vascular Institute, Falls Church, VA; 4Virginia Cardiac Surgery Quality Initiative, Charlottesville, VA; 5Virginia Commonwealth University, Richmond, VA. Purpose: Patients considering long-term mechanical circulatory support (MCS) device insertion are evaluated for comorbidities including diabetes mellitus. Heart failure produces insulin resistance, complicating glycemic control. Evidence is lacking for hemoglobin A1c goals in this population, and center-specific thresholds determine eligibility. We evaluate the impact of preoperative hemoglobin A1c on postoperative outcomes. Methods: Patient records for MCS procedures from 2008-2014 were extracted from a multi-institutional, regional Society of Thoracic Surgeons database. Device indications included bridge-to-transplant, bridge-to-recovery, and destination therapy. Patients were stratified by hemoglobin A1c: low (< 5.5), well-controlled (5.5-7.49), and high (≥ 7.5). Mortality, composite major morbidity (acute kidney injury, stroke, deep sternal wound infection, prolonged ventilation, or reoperation), and composite infectious complications (deep sternal wound, surgical site, driveline, or pump pocket infection) at 30 days were assessed using multi-level mixed effects regression modeling. In subset analysis, patients with a known diagnosis of diabetes were evaluated. Results: A total of 552 MCS patients (531 left ventricular assist devices,17 total artificial hearts, and 4 biventricular assist devices) had a median A1c of 6.3 [IQR: 5.8-7]. Patients in the high A1c group demonstrated higher rates of dyslipidemia, hypertension, and prior myocardial infarction. The remaining baseline characteristics were similar between groups. Unadjusted analysis demonstrated no significant difference in mortality, with rates of 13.9%, 11.3%, and 7.9% in the low, well-controlled, and high A1c groups. Major morbidity and infectious endpoints showed no significant difference, nor did individual components of those endpoints. In the subset of 283 patients with known diabetes, the median A1c was 6.9 [IQR: 6.3-7.8]. Analysis of these patients demonstrated no difference in the primary endpoints at the three A1c ranges. Conclusion: Early mortality and morbidity are not affected by degree of preoperative glycemic control in this analysis. Overall the findings suggest that rigid hemoglobin A1c criteria for preoperative glycemic control may not decrease early adverse events. Further studies are needed to evaluate impact on long-term outcomes. 1( 055) Role of ECMO in Acute Myocardial Infarction Complicating Cardiogenic Shock H. Lee ,1 S. Song,2 S. Kim,2 S. Oh,1 N. Kim,1 J. Kim,1 S. Lee,1 J. Park,1 J. Oh,1 J. Choi,1 H. Lee,1 K. Cha,1 T. Hong.1  1Department of Cardiology, Pusan National University Hospital, Busan, Korea, Republic of; 2Department of Thoracic Surgery, Pusan National University Hospital, Busan, Korea, Republic of. Purpose: There are increasing role of ECMO in refractory cardiogenic shock. Among them, temporary support for myocardial stunning during peri-myocardial infarction period is utmost importance. However, there are mostly small case series of single center experiences. We aimed to evaluate the role and characteristics of open use of ECMO from tertiary centers at current highly developed medical and procedural era. Methods: Of 11,974 patients of acute myocardial infarction from March 2006 through December 2014, 1,022 patients (8.5%) were complicated with cardiogenic shock during index hospitalization. Patients with available data were divided into two groups according to application of ECMO. Of 766 patients, 115 (15%) patients were in ECMO group and 651 (85%) patients were in No-ECMO group. Primary outcome was the in-hospital mortality. Survival analysis after propensity matching was performed. Results: Patients in ECMO group were younger, and had low initial mean blood pressure, large infarct size, and more left-sided coronary disease as