Impact of Preimplantation Tricuspid Regurgitation on Long Term Outcome in Patients Undergoing LVAD Implantation in the Era of Rotary Blood Pumps

Impact of Preimplantation Tricuspid Regurgitation on Long Term Outcome in Patients Undergoing LVAD Implantation in the Era of Rotary Blood Pumps

S240 The Journal of Heart and Lung Transplantation, Vol 32, No 4S, April 2014 heart catheterization variables. RVF was defined as post-operative in...

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S240

The Journal of Heart and Lung Transplantation, Vol 32, No 4S, April 2014

heart catheterization variables. RVF was defined as post-operative inotrope use ≥ 14 days or mechanical RV support. Pulmonary vasodilator use (nitric oxide, sildenafil and iloprost) was evaluated. Results: 65 patients (80% male, 50±14 years) were included: 52% Heartware (HVAD), 11% Heartmate II (HMII), 17% VentrAssist, 20% Jarvik. Pre-operative RVF risk was comparable to contemporary LVAD populations: 8% ventilated, 14% mechanical support, 86% on inotropes, 25% urea > 39mg/dL, 23% bilirubin ≥ 2 mg/dL, 31% RV:LV diameter ≥ 0.75, 27% RA:PCWP ratio > 0.63 and 36% RV stroke work index < 6 gm-m/m2/beat. The majority (91%) received a pulmonary vasodilator early and in high dose: 72% nitric oxide (20%, 37% and 15% for 1, 2 and ≥ 3 days respectively), 77% sildenafil (max 200±79 mg/day) and 66% iloprost (max 126±37 µg/day), figure 1. Median hospital stay was 26 (21) days. No patient required RV mechanical support. Of the 6 (9%) patients who met RVF criteria based on prolonged need for inotropes, 4 were bridged to transplant, 1 is alive with a LVAD at 3 years and 1 died at day 35 of an intracranial hemorrhage. Survival at 2 years was 77% (92% for HMII/HVAD): transplant 54%, alive 21%, recovery/explant 2%. Conclusion: Multiple pulmonary vasodilators were utilized early and in high dose for RV management after LVAD. This pharmacologic strategy appears to lower the incidence of RVF in a population at moderate risk, who achieved excellent outcomes. 

unloading. RV free wall to septum diameter increased significantly at enddiastole with LV unloading from 23±7mm to 25±7mm (p= .009). During LVAD support, tricuspid annular area (795±209mm2 vs 761±215mm2, p= .7) and total perimeter (111±17mm vs. 107±18mm before and during LVAD, respectively p= .9) did not change from baseline. Annular contraction was greatest in anterior and smallest in the septal region and was not altered with LV unloading. Tricuspid annulus had a complex 3D saddle shape geometry that was unaffected by LVAD support. Conclusion: Mechanical LV unloading increased RV free wall to septum diameter without affecting RV volume and did not alter dynamic motion or 3D geometry of the tricuspid annulus. Acute LV unloading and septal shift alone are not sufficient to significantly alter TV annulus dynamics and potentially contribute to tricuspid regurgitation.

Hemodynamics

Pump flow (l/min) HR (min-1) LVP max. (mmHg) LV EDP (mmHg) MAP (mmHg) RVP max. (mmHg) RV EDP (mmHg) RV EDV (ml) RV ESV (ml) CVP (mmHg)

Baseline (n= 7)

LVAD (n= 7)

p

108±34 100±12 15±10 92±14 26±4 12±5 60±11 52±11 12±2

3.8±0.3 100±30 80±28 8±10 104±14 22±6 11±4 58±12 49±12 11±2

.3 .12 .001 .02 .02 .14 .9 .8 .4

6( 49) Impact of Preimplantation Tricuspid Regurgitation on Long Term Outcome in Patients Undergoing LVAD Implantation in the Era of Rotary Blood Pumps A. Ghodsizad , M.M. Koerner, B. Soleimani, T.E. Stephenson, A. Haouzi, C. Brehm, W.E. Pae Jr., A. El-Banayosy.  Penn State Hershey Medical Center & Heart and Vascular Institute, Hershey, PA.

6( 48) Effect of Left Ventricular Assist Device on Ovine Tricuspid Annular 3D Geometry M. Malinowski ,1 P. Wilton,2 A. Khaghani,2 M. Brown,2 D. Karia,2 D. Langholz,2 V. Hooker,2 L. Eberhart,2 B. Hooker,2 T. Timek.2   1Department of Cardiac Surgery, Medical University of Silesia, Katowice, Poland; 2Meijer Heart and Vascular Institute at Spectrum Health, Grand Rapids, MI. Purpose: Left ventricular unloading may alter right ventricular shape and function and lead to tricuspid regurgitation, but the effect of left ventricular assist device (LVAD) support on tricuspid annular dynamics and geometry is unknown. Methods: In seven open chest anesthetized sheep 9 sonomicrometry crystals were implanted on the right ventricle (RV). Additional 9 crystals were implanted around the tricuspid annulus with one crystal at each commissure defining three separate annular regions: anterior, posterior, and septal. LV unloading was achieved by connecting a cannula in the aorta and left atrium to a continuous flow external pump. Sonomicrometry and epicardial echocardiographic data were collected during three consecutive heart beats before and after full LVAD support. Tricuspid annular area, regional and total perimeter were calculated from crystal coordinates while annular 3D geometry was expressed as the orthogonal distance of each annular crystal to the least square plane of all annular crystals. Results: Hemodynamic parameters are presented in Table 1. There was no significant tricuspid regurgitation observed either before or during LV

Purpose: Tricuspid regurgitation is a known finding in patients with endstage heart failure. For managing tricuspid valve regurgitation (TR) in patients undergoing left ventricular assist device (LVAD)implantation the optimal operative strategy is unclear. Our intention in this study was to evaluate the outcome of (3+/4+) TR after LVAD implantation. Methods: Pts who underwent LVAD implantation were divided in 2 groups, group 1 with significant TR (≥ 3+ TR) vs. group II without significant TR prior to LVAD implantation. In both groups pts underwent Heartmate II® (HM II) and HeartWare LVAS® (HW) implantation from 2011 to 2013 and were retroprospectivly analyzed. Pts were evaluated for perioperative and intraoperative outcome, including hemodynamic and end-organ function parameter. Pts who received ECMO implantation were excluded from this study. Results: Sixty-two pts (n= 11 female, 18%) were implanted during the study period. 32 patients were assigned to group I and 30 pts to group II. There were no statistically significant differences in the base line characteristics, as well as postoperative complications between group I vs. group II, including age, gender, implanted LVAD system, etiology, InterMACS classification, treatment strategy (DT/BTT), CVP, GI bleeding, cerebrovascular accident and drive line infection. There were statistically significant differences in group I vs. group II regarding preimplant PAPs 54±13 vs. 45±14 (p= 0.056), platelet count 174±53 vs. 218±68 (p= 0.052), INR 1.24 ± 0.2 vs. 1.09±0.1 (p= 0.02), T Bilirubin 1.1±0.6 vs. 0.6±0.3 (p= 0.028). 1 pt required RVAD implantation in group I. Tricuspid valve repair (De vega annuloplasty) was performed in 1 pt in the same group. The 2 year survival rate was 67% vs. 70% in group 1 vs. group II (p= 0.823). Conclusion: Non surgical management of significant tricuspid regurgitation showed promising outcomes. Surgical management of tricuspid regurgitation may not be necessary at time of LVAD implantation.

Abstracts S241 6( 50) Strong Correlation Between Alere Home INR and Core Lab INR in Patients Supported with CF-LVAD M. Dionizovik-Dimanovski , A.P. Levin, K.P. Mody, E. Simonich, A.R. Garan, M. Yuzefpolskaya, H. Takayama, Y. Naka, P.C. Colombo, N. Uriel, U.P. Jorde.  Medicine, Columbia University, New York, NY. Purpose: Thromboembolic events are common adverse events in patients with Left Ventricular Assist Devices (LVAD) requiring the use of long-term anticoagulation therapy. Patient self-testing (PST) of INR with the Alere home monitoring device has been shown to both simplify frequent monitoring, and improve clinical outcome of warfarin therapy, as compared to standard care in patients treated with warfarin. However, PST was not tested in LVAD patients. The purpose of this study is to determine the reliability of self-testing devices in patients on LVAD support. Methods: Correlation study was done in 30 patients who were on LVAD support and stable anticoagulation therapy for more than 3 weeks. Venous blood and INR values from capillary whole blood samples on Alere home monitoring device were drawn in the same time, blood was sent to core lab as a STAT for analysis. Patient hematocrit, liver enzymes, thyroid hormone levels and use of amiodarone were taken in consideration since they can affect the warfarin metabolism and INR results respectively. Results: Thirty LVAD patients were included in the study with a mean age of 60(±14) years. Twenty six (87%) were male, and the mean time on LVAD support at the time of INR measurement was 12.5 months ranging from 0.853 to 55.86 months. There was a strong correlation between the venous and capillary INR values with a correlation coefficient of 0.8245 (r²= 0.679, p< 0.0001). Mean percentage difference between the methods was 10.8% (-13.2% -34.9%). Results remained the same regardless the use of amiodarone or abnormal hematocrit, liver enzymes or thyroid hormone levels. Conclusion: In conclusion Alere home INR self-monitoring device appears reliable and accurate in LVAD patients on long term oral anticoagulation therapy (OAT). 

Methods: All LVAD recipients followed by the Artificial Heart Program at Intermountain Medical Center who had INRs managed before and after implementation of CDS tool were included in the study. Implementation of the tool occurred April 2013 after extensive planning and training with clinic staff and providers. The Intermountain CDS tool is based on anticoagulation management guidelines of the American College of Chest Physicians and includes dosing guides for patients. Data collected included INR values, basic demographics, etiology of heart failure, and adverse events. Optimal INR control was determined by the percent time in therapeutic range (TTR) pre-CDS and post-CDS implementation. Results: Eighteen patients with pre- and post-CDS data were included. Average age was 67 years and the majority were male. Out of 18 patients, 15 (83%) demonstrated improvement in TTR post-CDS tool implementation. Average TTR increased for the group while number of dose changes and number of laboratory draws decreased. There was no increase in bleeding or clotting events post-CDS implementation (Table 1). Conclusion: The use of a CDS tool improved INR TTR for LVAD patients without increasing the incidence of adverse events. Standardization of warfarin management with CDS should be considered in the LVAD patient population. Advanced heart failure programs elsewhere are encouraged to incorporate CDS in their anticoagulation management of LVAD patients to improve patient quality of care.

Demographics & Results Average Age (years) % Male Etiology of HF (%) _Ischemic _Idiopathic _Valvular Average TTR (%) Average # of dose changes (per 30 days) Average # of lab draws (per 30 days) Adverse Events _Bleeding _Clotting

66.8±11.1 86.7 _ 72 (n= 13) 22 (n= 4) 6 (n= 1) Pre-CDS 47.2 1.72 4.92 _ 3 1

Post-CDS 57.5 0.68 2.93 _ 2 0

6( 52) Tolerability and Biological Effects of Long Acting Octreotide in Patients With Continuous Flow Left Ventricular Assist Devices R. Malhotra ,1 C.T. DeWilde,1 M. Smallfield,2 D.F. Brophy,3 K.B. Shah.2   1Internal Medicine/Critical Care Medicine, VCU Health System, Richmond, VA; 2Internal Medicine/Cardiology, VCU Health System, Richmond, VA; 3Pharmacy, VCU Health System, Richmond, VA.

6( 51) Improving Prothrombin Time International Normalized Ratio (INR) Control in Left Ventricular Assist Device (LVAD) Patients with Computerized Decision Support J.L. Nixon , D. Budge, S. Stoker, W. Caine, R.A. Alharethi, H. Smith, B. Reid, G. Thomsen, S. Clayson, M. Goddard, J. Doty, A.G. Kfoury.   Artificial Heart Program at Intermountain Medical Center, Salt Lake City, UT. Purpose: Systemic anticoagulation with warfarin is standard of care in LVAD patients to prevent pump thrombosis. However, LVADs can promote inflammation, coagulation and platelet dysfunction rendering tight INR control difficult. Computerized decision support (CDS) tools can improve INR control in patients on warfarin but have not been studied in LVAD patients. The purpose of this study is to describe the impact of a CDS tool for INR management in an LVAD patient population.

Purpose: No disease specific therapies for left ventricular assist device (LVAD)-related gastrointestinal (GI) bleeding are available. Data exist for octreotide to treat variceal bleeding, arteriovenous malformation bleeding, and von Willebrand syndrome. Octreotide modulates platelet activation, angiogenesis and splanchnic blood flow to potentially reduce GI bleeding. We conducted a study to evaluate the tolerability and hematologic effects on bleeding and coagulation of octreotide in LVAD patients. Our objective was to demonstrate safety in patients with GI bleeding. We also evaluated the feasibility of monthly administration, changes in hematologic parameters for coagulation, vascular endothelial growth factor (VEGF) levels, and platelet activity. Methods: Ten ambulatory LVAD patients were enrolled. Those with active bleeding, poorly controlled thyroid disease or diabetes were excluded. Patients had baseline clinical evaluation and laboratory values measured and then received monthly injections of the 20 mg depot (LAR) formulation of octreotide for four doses followed by a washout period. Physical examination, assessment of side effects and laboratory data were performed during monthly clinic visits. Labs collected included monthly basic metabolic panel, complete blood count, fructosamine, quarterly A1C, vascular endothelial growth factor (VEGF), von Willebrand factor (vWF), von Willebrand factor activity assay, thyroid stimulating hormone, platelet function assay, and fibrinogen.