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Reduction in Driveline Infection Rates: Results from the HeartMate II Multicenter Silicone-Skin-Interface (SSI) Registry
Abstracts S11 Purpose: Despite current recommendations to treat LVAD patients with both warfarin and aspirin, those who bleed often require a reduction in their antithrombotic therapies. To document and characterize patients who can be safely managed with a reduced anti-thrombotic regimen, TRACE (Study of Reduced Anti-Coagulation/Anti-platelet Therapy in Patients with the HeartMatE II LVAS) was initiated in the US and Europe. Methods: The TRACE-US enrolled HMII outpatients who at enrollment or as of Jan 1, 2011 were on a reduced anti-thrombotic (RT) regimen: warfarin only (RT-w), aspirin only (RT-a), or no anticoagulant or antiplatelet therapy (RT-n). The indication for RT, subsequent anti-thrombotic changes, as well as any bleeding, stroke, or pump thrombosis after RT were documented. Patients are to be followed for up to 24 months. In this report we present initial results in the first year post RT initiation. Results: 100 outpatients on RT were enrolled in the TRACE-US Study from 9 sites. The mean age was 65±11 yrs, 86% were male, 56% had ischemic etiology and 63% were DT. As of Oct 2013, 86 patients had been on RT for at least 12 months (n= 69) or reached an outcome (n= 17). The primary reason for RT was to control bleeding (GI or epistaxis) in 80%. RT-w, RT-a and RT-n, were used in 60%, 19%, and 21% of the patients, with mean INR at enrollment of 1.9±0.7, 1.1±0.7, and 1.1±0.2, respectively. The median HMII support duration was 1.2 yrs at the time of RT initiation (29 days -7.5 yrs). Among the 17 patients who reached an outcome, 7 expired, 9 were transplanted and 1 withdrew from the study. In the first year of RT, there were 29 bleeding events, 6 ischemic and 0 hemorrhagic strokes and 4 pump thromboses. At one year post-RT, freedom from bleeding, ischemic stroke, hemorrhagic stroke, and pump thrombosis were 66%, 94%, 100%, and 95%, respectively. Conclusion: Preliminary results from the TRACE-US Study suggest that reducing anti-thrombotic therapies on a chronic basis in response to persistent non-surgical bleeding events may be safe in selected patients. Further analysis of the TRACE data may help better characterize those who require and those who can safely tolerate reduced anti-thrombotic strategies. 6( ) Minimal Adverse Events in HeartMate II Patients with No Antiplatelet Therapy: Preliminary Results from the European TRACE Study I. Netuka ,1 P.Y. Litzler,2 M. Berchtold-Herz,3 E. Flecher,4 D. Zimpfer,5 L. Damme,6 K.S. Sundareswaran,7 D.J. Farrar,7 J.D. Schmitto.8 1Department of Cardiac Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic; 2Department of Thoracic and Cardiovascular Surgery, Rouen University Hospital Charles Nicolle, Rouen, France; 3Department of Cardiovascular Surgery, Heart Center, University of Freiburg, Freiburg, Germany; 4Department of Thoracic and Cardiovascular Surgery, CHU Pontchaillou, Rennes, France; 5Department of Cardiothoracic Surgery, University of Vienna, Vienna, Austria; 6Thoratec Europe Limited, London, United Kingdom; 7Research and Scientific Affairs, Thoratec Corporation, Pleasanton, CA; 8Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany. Purpose: Current recommendations for antithrombotic therapy for patients with the HeartMate II (HMII) left ventricular assist device (LVAD) include the use of both an anticoagulant (Warfarin) and an antiplatelet agent (Aspirin). However, in order to reduce the risk of bleeding in the setting of acquired von Willebrand syndrome, some physicians have re-considered the need for anti-platelet therapy in HMII patients. Also in Europe (EU), other anticoagulants are regularly being used. Methods: 103 HMII patients from 9 centers were enrolled in the European arm of the TRACE Study (STudy of Reduced Anti-Coagulation/Anti-platelet Therapy in Patients with the HeartMatE II LVAS), which evaluates the incidence of adverse events in HMII patients on reduced antithrombotic [RT] therapy with a single anticoagulant (vitamin K antagonist) and with no antiplatelet agents. Results of an interim analysis of data collected from 74 of the 103 patients who were on RT for more than 1 year or reached their outcome (e.g. transplant) are reported here. Results: Median age of this cohort was 56 [24-72] years, 93% were male, 63% were INTERMACS profile 1-3, and 84% received the HMII as a bridge to transplantation. 92% were placed on RT therapy as a center standard-of-care or due to physician preference, 7% as a response to bleeding, and 2% due to patients undergoing a non-VAD related surgery. All patients
were intended to be treated with vitamin K antagonists (AVK) only (23 Warfarin, 24 Fluindione, 26 Phenprocoumon, and 1 Acenocoumarol), with no antiplatelet therapy. Median HMII support duration on RT therapy was 18 [1-73] months. Average INR at enrollment was 2.3 ± 0.5. At one year, freedom from ischemic stroke, hemorrhagic stroke, and device thrombosis post initiation of RT therapy was 95± 3%, 98 ± 2%, and 96 ± 2% respectively. Nine patients (12%) experienced a bleeding event while on RT therapy. Conclusion: This preliminary analysis of the observational TRACE-EU study suggests that managing HMII patients with a vitamin K antagonist without aspirin may help to reduce the incidence of major bleeding without increasing the risk of thromboembolic events including ischemic stroke and device thrombosis. Further prospective studies are needed. 7( ) Reduction in Driveline Infection Rates: Results from the HeartMate II Multicenter Silicone-Skin-Interface (SSI) Registry D. Dean ,1 G.A. Ewald,2 A. Tatooles,3 B.C. Sheridan,4 R.J. Brewer,5 C. Caldeira,6 F. Kallel,7 D.J. Farrar,7 S.A. Akhter.8 1Piedmont Healthcare, Atlanta, GA; 2Washington University School of Medicine, St Louis, MO; 3Advocate Christ Medical Center, Oaklawn, IL; 4University of North Carolina, Chapel Hill, NC; 5Henry Ford Hospital, Detroit, MI; 6Tampa General Hospital, Tampa, FL; 7Thoratec Corporation, Pleasanton, CA; 8University of Chicago, Chicago, IL. Purpose: Single center experience has suggested reduction in driveline (DL) infection rates after changing the surgical tunneling technique to keep the entire DL velour portion in the subcutaneous tunnel. This results in a Silicone-to-Skin Interface (SSI) at the exit site. To assess the long term freedom from DL infection associated with this technique, a multi-center SSI registry was initiated. It was hypothesized that the modified tunneling technique is associated with at least 50% reduction in DL infection at one year post implant when compared to the velour-to-skin method used in the HMII Destination Therapy (DT) trial. Methods: SSI is both a prospective and retrospective registry of HMII patients. The retrospective cohort consists of 200 pts with the SSI tunneling method on HMII support for at least 10 mos at the time of enrollment. The actuarial freedom from DL infection post LVAD implantation was determined with the Kaplan-Meier method in patients enrolled in the SSI retrospective cohort, and was compared to that in 201 pts also with at least 10 mos HMII support from the HMII DT clinical trial where a small section of the velour portion of the DL was externalized. Results: Between June 2012 and June 2013, 200 pts (50% BTT, 50% DT) with a median age of 60 yrs (range: 20-80) were enrolled in the retrospective cohort from 15 US sites. The mean follow-up was 19 mos (range: 7-46 mos; cumulative: 322 pt-yrs of support). There were 39 DL infection events (0.12 events /pt-yr) in 26 pts, with time to event ranging from 2.1 to 13.8 mos. The actuarial freedom from DL infection (93% and 84% at 12 and 24 mos respectively) was significantly (p< 0.001, log-rank) improved compared to the HMII DT trial (73% and 65%). Conclusion: These results suggest that leaving the entire DL velour portion below the skin is associated with a significant reduction in DL infection when compared to results from the HMII DT trial.
S12
The Journal of Heart and Lung Transplantation, Vol 32, No 4S, April 2014
8( ) Right Ventricular Dysfunction Is Associated with Gastrointestinal Bleeding in Patients Supported with Continuous-Flow LVADs C.T. Sparrow , M.E. Nassif, D.S. Raymer, E. Novak, S.J. LaRue, J.D. Schilling. Washington University School of Medicine, St. Louis, MO. Purpose: Gastrointestinal bleeding (GIB) is a significant complication in patients supported with continuous-flow LVADs. The impact of right ventricular (RV) dysfunction on the risk of GIB has not been investigated. This study tests the hypothesis that severe RV dysfunction is associated with an increased risk of GI bleeding post-LVAD. Methods: We retrospectively identified 219 patients who survived index hospitalization after implantation of Heart Mate II or Heartware HVAD from 6/2009 to 4/2013. Of these, 212 had a pre-LVAD echocardiogram in our system. Patients with severe RV dysfunction on pre-LVAD echocardiogram (n = 37) were compared to patients without severe RV dysfunction (n = 175). The primary outcome was time to GI bleed. Kaplan-Meier curves were created to evaluate time to first GI bleed and the log-rank test was used to compare event-free survival rates. Results: The majority of patients were male (78%) with a median INTERMACS profile of 2 at LVAD implant. There were no significant differences between cohorts with respect to demographics, comorbidities, device type, INR or aspirin strategy following LVAD implant. During follow up 80 patients had GIB events: 23 of 37 (62%) in the severe RV dysfunction group vs. 57 of 175 (33%) in the control group (p = 0.001). Kaplan-Meier analysis was also statistically significant, p = 0.02 (Figure). After adjustment for age and ICM, severe RV dysfunction was associated with increased risk of GIB (HR 1.859, 95% CI 1.143-3.024; p = 0.013). Conclusion: In this relatively large, single center sample of patients supported with continuous-flow LVADs, severe RV dysfunction on pre-LVAD echocardiogram was associated with an increased risk of GIB. Further studies are needed to investigate possible mechanisms by which RV dysfunction increases the risk of GIB and to identify patient populations who may benefit from alterations in anti-platelet and anticoagulation strategies.
9( ) Continuous Left Atrial Pressure Monitoring Improves Outcomes in Heartmate II Patients I. Gosev , R.C. Neely, M. Leacche, S. McGurk, Q. Javed, L. Cohn, G.S. Couper. Cardiac Surgery, Brigham and Women's Hospital, Jamaica Plain, MA. Purpose: Left atrial (LA) pressure is indicative of left ventricular(LV) function, LV preload and LV afterload. Current monitoring methods such as pulmonary artery lines give an indirect measurement of LV preload. We hypothesize that direct measurement of LV preload with a Codman Microsensor(off label) will facilitate more accurate fluid management and optimal ventricular assist device (VAD) settings, thereby improving outcomes after VAD implantation. Methods: Between 2/10-9/13, 98 patients underwent LVAD implantation (Heartmate II). 78.6%(77/98) had a Codman Microsensor placed in the LA for intra-op and post op monitoring(LA line group); 21.4%(21/98) had
conventional monitoring (no LA line group). Indications for VAD in LA line and no LA line groups differed for bridge to transplantation 67.5%(52/77) v. 38.1%(8/21)(p< 0.022), destination therapy 29.9%(23/77) v. 57.7%(12/21) (p< 0.004), respectively. No differences were seen for bridge to recovery in LA line 1.3%(1/77) v. no LA line 4.8%(1/21), p< 0.384. Prior VAD malfunction was seen in 1.3%(1/77) in LA line. Results: Mean age was 54.1 yrs (+/-11.7). Median LV ejection fraction 15%(15, 20), pre VAD pulmonary capillary wedge pressure 23 mmHg (18,27), and baseline demographics were similar between groups, except mean body surface area in LA line 2.01(+/-.24)m2 v. no LA line 1.78(+/-.20) m2(p< 0.001) and women in LA line 18.2%(14/77) v. 42.9%(9/21), p< 0.038. Median perfusion time was shorter in LA line 106 mins (82,151) v. no LA line 154 mins (111, 190), p< 0.005. The LA line group had significantly shorter median ventilation time 17 hrs (10, 88) v. 61 hrs (13,234)(p< 0.033), initial ICU time 153 hrs (113, 253) v. 225 hrs (145, 356)(p< 0.022), and total ICU time of 154 hrs(115,258) v. 221 hrs(162,385), p< 0.019. Median post operative length of stay trended towards significance in LA line 22 days (16,39) v. no LA line 31 days (22,40), p< 0.053. Overall operative mortality was 5.1%(5/98) and 3.9%(3/77) in LA line v. 9.5%(2/21) no LA line, p< 0.291. Conclusion: LA pressure monitoring system using a Codman Microsensor offers safe, reliable and accurate monitoring for LV preload during and after LVAD implantation. We observed shorter ventilation time, ICU and hospital length of stay in continuously monitored patients compared to conventional monitoring. Continuous LA pressure monitoring technique may improve outcomes after LVAD placement. 1( 0) Relationship Between Speed and Left Ventricular Size in HVAD Patients: Lessons from the HVAD Ramp Test Study N. Uriel , A.P. Levin, K.P. Mody, M. Dionizovik-Dimanovski, A.R. Garan, M. Yuzefpolskaya, H. Takayama, P.C. Colombo, Y. Naka, U.P. Jorde. Medicine, Columbia University, New York, NY. Purpose: Ramp tests have been widely used both for speed adjustment and device malfunction identification in axial flow LVAD pts (HM2). The aim of this study was to test for the first time the ramp test in centrifugal flow HVAD pts. Methods: A prospective ramp test protocol for HVAD pts was conducted in 15 consecutive pts prior to discharge, or at the time of suspected device malfunction. Vital signs, device and echo parameters, including left ventricular end-diastolic dimension (LVEDD), frequency of aortic valve (AV) opening and valvular insufficiency, were recorded following 2 minute increments of 100 rpm from 2,300 to 3,200 rpm. Results: Eighteen ramp tests were performed, 13 for speed optimization and 5 for assessment of device malfunction. Mean speed was 2642±245 rpm, and the AV closed at a mean speed of 2761±225 rpm, with the exception of 2 pts whose AV never closed. A nonlinear relationship between device speed and LVEDD was observed in pts with normally functioning HVADs. The LVEDD did not change significantly before the AV was closed, but rapidly decompressed after, with mean LVEDD slopes of -0.13±0.12 before and -0.26±0.22 after AV closure (p= 0.076). Device flow rapidly increased prior to AV closure with a mean slope of 0.25±0.09, and flattened after it, with a mean slope of 0.06±0.19 (p= 0.014). Two pts had device obstruction with completely flat LVEDD slopes and erratic flow data. Fifteen tests were conducted to completion, without any events. Three were stopped early, one due to VT and two because of suction events. Conclusion: This is a novel study investigating the relationship between speed and LVAD decompression in the HVAD pts. The HVAD decompresses the LV in a nonlinear way, with significantly less decompression than seen historically HM2. Thus, LVEDD slopes from HVAD ramp tests should not be analyzed based on the HM2 data available. Speed adjustment in HVAD patients should not be based on the degree of LV decompression. Flow slopes may offer a better approach to assess device malfunction in HVAD patients.
were intended to be treated with vitamin K antagonists (AVK) only (23 Warfarin, 24 Fluindione, 26 Phenprocoumon, and 1 Acenocoumarol), with no antiplatelet therapy. Median HMII support duration on RT therapy was 18 [1-73] months. Average INR at enrollment was 2.3 ± 0.5. At one year, freedom from ischemic stroke, hemorrhagic stroke, and device thrombosis post initiation of RT therapy was 95± 3%, 98 ± 2%, and 96 ± 2% respectively. Nine patients (12%) experienced a bleeding event while on RT therapy. Conclusion: This preliminary analysis of the observational TRACE-EU study suggests that managing HMII patients with a vitamin K antagonist without aspirin may help to reduce the incidence of major bleeding without increasing the risk of thromboembolic events including ischemic stroke and device thrombosis. Further prospective studies are needed. 7( ) Reduction in Driveline Infection Rates: Results from the HeartMate II Multicenter Silicone-Skin-Interface (SSI) Registry D. Dean ,1 G.A. Ewald,2 A. Tatooles,3 B.C. Sheridan,4 R.J. Brewer,5 C. Caldeira,6 F. Kallel,7 D.J. Farrar,7 S.A. Akhter.8 1Piedmont Healthcare, Atlanta, GA; 2Washington University School of Medicine, St Louis, MO; 3Advocate Christ Medical Center, Oaklawn, IL; 4University of North Carolina, Chapel Hill, NC; 5Henry Ford Hospital, Detroit, MI; 6Tampa General Hospital, Tampa, FL; 7Thoratec Corporation, Pleasanton, CA; 8University of Chicago, Chicago, IL. Purpose: Single center experience has suggested reduction in driveline (DL) infection rates after changing the surgical tunneling technique to keep the entire DL velour portion in the subcutaneous tunnel. This results in a Silicone-to-Skin Interface (SSI) at the exit site. To assess the long term freedom from DL infection associated with this technique, a multi-center SSI registry was initiated. It was hypothesized that the modified tunneling technique is associated with at least 50% reduction in DL infection at one year post implant when compared to the velour-to-skin method used in the HMII Destination Therapy (DT) trial. Methods: SSI is both a prospective and retrospective registry of HMII patients. The retrospective cohort consists of 200 pts with the SSI tunneling method on HMII support for at least 10 mos at the time of enrollment. The actuarial freedom from DL infection post LVAD implantation was determined with the Kaplan-Meier method in patients enrolled in the SSI retrospective cohort, and was compared to that in 201 pts also with at least 10 mos HMII support from the HMII DT clinical trial where a small section of the velour portion of the DL was externalized. Results: Between June 2012 and June 2013, 200 pts (50% BTT, 50% DT) with a median age of 60 yrs (range: 20-80) were enrolled in the retrospective cohort from 15 US sites. The mean follow-up was 19 mos (range: 7-46 mos; cumulative: 322 pt-yrs of support). There were 39 DL infection events (0.12 events /pt-yr) in 26 pts, with time to event ranging from 2.1 to 13.8 mos. The actuarial freedom from DL infection (93% and 84% at 12 and 24 mos respectively) was significantly (p< 0.001, log-rank) improved compared to the HMII DT trial (73% and 65%). Conclusion: These results suggest that leaving the entire DL velour portion below the skin is associated with a significant reduction in DL infection when compared to results from the HMII DT trial.
S12
The Journal of Heart and Lung Transplantation, Vol 32, No 4S, April 2014
8( ) Right Ventricular Dysfunction Is Associated with Gastrointestinal Bleeding in Patients Supported with Continuous-Flow LVADs C.T. Sparrow , M.E. Nassif, D.S. Raymer, E. Novak, S.J. LaRue, J.D. Schilling. Washington University School of Medicine, St. Louis, MO. Purpose: Gastrointestinal bleeding (GIB) is a significant complication in patients supported with continuous-flow LVADs. The impact of right ventricular (RV) dysfunction on the risk of GIB has not been investigated. This study tests the hypothesis that severe RV dysfunction is associated with an increased risk of GI bleeding post-LVAD. Methods: We retrospectively identified 219 patients who survived index hospitalization after implantation of Heart Mate II or Heartware HVAD from 6/2009 to 4/2013. Of these, 212 had a pre-LVAD echocardiogram in our system. Patients with severe RV dysfunction on pre-LVAD echocardiogram (n = 37) were compared to patients without severe RV dysfunction (n = 175). The primary outcome was time to GI bleed. Kaplan-Meier curves were created to evaluate time to first GI bleed and the log-rank test was used to compare event-free survival rates. Results: The majority of patients were male (78%) with a median INTERMACS profile of 2 at LVAD implant. There were no significant differences between cohorts with respect to demographics, comorbidities, device type, INR or aspirin strategy following LVAD implant. During follow up 80 patients had GIB events: 23 of 37 (62%) in the severe RV dysfunction group vs. 57 of 175 (33%) in the control group (p = 0.001). Kaplan-Meier analysis was also statistically significant, p = 0.02 (Figure). After adjustment for age and ICM, severe RV dysfunction was associated with increased risk of GIB (HR 1.859, 95% CI 1.143-3.024; p = 0.013). Conclusion: In this relatively large, single center sample of patients supported with continuous-flow LVADs, severe RV dysfunction on pre-LVAD echocardiogram was associated with an increased risk of GIB. Further studies are needed to investigate possible mechanisms by which RV dysfunction increases the risk of GIB and to identify patient populations who may benefit from alterations in anti-platelet and anticoagulation strategies.
9( ) Continuous Left Atrial Pressure Monitoring Improves Outcomes in Heartmate II Patients I. Gosev , R.C. Neely, M. Leacche, S. McGurk, Q. Javed, L. Cohn, G.S. Couper. Cardiac Surgery, Brigham and Women's Hospital, Jamaica Plain, MA. Purpose: Left atrial (LA) pressure is indicative of left ventricular(LV) function, LV preload and LV afterload. Current monitoring methods such as pulmonary artery lines give an indirect measurement of LV preload. We hypothesize that direct measurement of LV preload with a Codman Microsensor(off label) will facilitate more accurate fluid management and optimal ventricular assist device (VAD) settings, thereby improving outcomes after VAD implantation. Methods: Between 2/10-9/13, 98 patients underwent LVAD implantation (Heartmate II). 78.6%(77/98) had a Codman Microsensor placed in the LA for intra-op and post op monitoring(LA line group); 21.4%(21/98) had
conventional monitoring (no LA line group). Indications for VAD in LA line and no LA line groups differed for bridge to transplantation 67.5%(52/77) v. 38.1%(8/21)(p< 0.022), destination therapy 29.9%(23/77) v. 57.7%(12/21) (p< 0.004), respectively. No differences were seen for bridge to recovery in LA line 1.3%(1/77) v. no LA line 4.8%(1/21), p< 0.384. Prior VAD malfunction was seen in 1.3%(1/77) in LA line. Results: Mean age was 54.1 yrs (+/-11.7). Median LV ejection fraction 15%(15, 20), pre VAD pulmonary capillary wedge pressure 23 mmHg (18,27), and baseline demographics were similar between groups, except mean body surface area in LA line 2.01(+/-.24)m2 v. no LA line 1.78(+/-.20) m2(p< 0.001) and women in LA line 18.2%(14/77) v. 42.9%(9/21), p< 0.038. Median perfusion time was shorter in LA line 106 mins (82,151) v. no LA line 154 mins (111, 190), p< 0.005. The LA line group had significantly shorter median ventilation time 17 hrs (10, 88) v. 61 hrs (13,234)(p< 0.033), initial ICU time 153 hrs (113, 253) v. 225 hrs (145, 356)(p< 0.022), and total ICU time of 154 hrs(115,258) v. 221 hrs(162,385), p< 0.019. Median post operative length of stay trended towards significance in LA line 22 days (16,39) v. no LA line 31 days (22,40), p< 0.053. Overall operative mortality was 5.1%(5/98) and 3.9%(3/77) in LA line v. 9.5%(2/21) no LA line, p< 0.291. Conclusion: LA pressure monitoring system using a Codman Microsensor offers safe, reliable and accurate monitoring for LV preload during and after LVAD implantation. We observed shorter ventilation time, ICU and hospital length of stay in continuously monitored patients compared to conventional monitoring. Continuous LA pressure monitoring technique may improve outcomes after LVAD placement. 1( 0) Relationship Between Speed and Left Ventricular Size in HVAD Patients: Lessons from the HVAD Ramp Test Study N. Uriel , A.P. Levin, K.P. Mody, M. Dionizovik-Dimanovski, A.R. Garan, M. Yuzefpolskaya, H. Takayama, P.C. Colombo, Y. Naka, U.P. Jorde. Medicine, Columbia University, New York, NY. Purpose: Ramp tests have been widely used both for speed adjustment and device malfunction identification in axial flow LVAD pts (HM2). The aim of this study was to test for the first time the ramp test in centrifugal flow HVAD pts. Methods: A prospective ramp test protocol for HVAD pts was conducted in 15 consecutive pts prior to discharge, or at the time of suspected device malfunction. Vital signs, device and echo parameters, including left ventricular end-diastolic dimension (LVEDD), frequency of aortic valve (AV) opening and valvular insufficiency, were recorded following 2 minute increments of 100 rpm from 2,300 to 3,200 rpm. Results: Eighteen ramp tests were performed, 13 for speed optimization and 5 for assessment of device malfunction. Mean speed was 2642±245 rpm, and the AV closed at a mean speed of 2761±225 rpm, with the exception of 2 pts whose AV never closed. A nonlinear relationship between device speed and LVEDD was observed in pts with normally functioning HVADs. The LVEDD did not change significantly before the AV was closed, but rapidly decompressed after, with mean LVEDD slopes of -0.13±0.12 before and -0.26±0.22 after AV closure (p= 0.076). Device flow rapidly increased prior to AV closure with a mean slope of 0.25±0.09, and flattened after it, with a mean slope of 0.06±0.19 (p= 0.014). Two pts had device obstruction with completely flat LVEDD slopes and erratic flow data. Fifteen tests were conducted to completion, without any events. Three were stopped early, one due to VT and two because of suction events. Conclusion: This is a novel study investigating the relationship between speed and LVAD decompression in the HVAD pts. The HVAD decompresses the LV in a nonlinear way, with significantly less decompression than seen historically HM2. Thus, LVEDD slopes from HVAD ramp tests should not be analyzed based on the HM2 data available. Speed adjustment in HVAD patients should not be based on the degree of LV decompression. Flow slopes may offer a better approach to assess device malfunction in HVAD patients.