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HeartMate 3 Surgical Implant Technique and Outcomes in the MOMENTUM 3 Trial
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The Journal of Heart and Lung Transplantation, Vol 38, No 4S, April 2019
New York, NY; 3Northwestern University, Chicago, IL; 4University of Utah, Salt Lake City, UT; and the 5Stanford University, Palo Alto, CA. Summary of Objectives: Ramp tests are used to optimize left ventricular assist device (LVAD) speed and tailor medical therapy. The addition of invasive hemodynamics to the ramp test has the potential to provide further information that will improve patient management. The aim of this study is to investigate the effects of a hemodynamic-guided approach to LVAD management on clinical outcomes, including exercise capacity and quality of life measures. Methods: RAMP-IT-UP is a multi-center, randomized trial comparing two management strategies for LVAD patients: a hemodynamic approach employing a hemodynamic ramp study to optimize LVAD speed and medical therapy (HR arm) and a standard of care approach employing transthoracic echocardiography (TTE) for optimization of LVAD speed and medical therapy (TTE arm). This study enrolled 41 patients (22 in HR arm, 19 in TTE arm) who had an HVAD LVAD and were 1-3 months postimplantation. All patients will be followed for six months after enrollment. Primary endpoints are changes in the 6-minute walk test, New York Heart Association Class and Kansas City Cardiomyopathy Questionnaire score. Exploratory endpoints will include the incidence of clinical events (mortality, heart failure admission, arrhythmias, gastrointestinal bleeding, stroke, pump thrombosis, aortic insufficiency and driveline infection). The analysis will include 6-month results for the full study cohort. The last patient was enrolled in September 2018, and will complete follow-up in March 2019. Endpoints: This is the first randomized study of two different clinical management strategies for chronic LVAD patients. This study will evaluate the benefits of a hemodynamic-guided approach on quality of life and outcomes of LVAD patients. (Funded by Medtronic; ClinicalTrials.gov Number, NCT03021239)
then Sew was associated with longer median bypass times when compared to Sew then Cut (86 vs 77.5 minutes, p = 0.033). In the LT Cohort, there were no significant differences in 2-year survival between the groups (logrank P=0.16). However, there was a trend for Cut then Sew to have a higher risk of stroke compared to Sew then Cut (Figure). Patients implanted with Cut then Sew vs Sew then Cut were also more likely to have a hemocompatibility score>1 (27% vs 15%, p=0.048). Conclusion: We demonstrate that the Cut then Sew method used additional bypass time and may confer a higher stroke risk and HRAE net burden compared to Sew then Cut pump implantation technique.
169 HeartMate 3 Surgical Implant Technique and Outcomes in the MOMENTUM 3 Trial C. Salerno,1 Y. Naka,2 S.C. Silvestry,3 D.J. Goldstein,4 J.C. Cleveland,5 A. Bansal,6 N.A. Mokadam,7 J.N. Schroder,8 V. Jeevanandam,9 A.J. Tatooles,10 J. Chuang,11 and J.W. Long.12 1St. Vincent Heart Center, Indianapolis, IN; 2Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital, New York, NY; 3Florida Hospital, Orlando, FL; 4Montefiore Einstein Center for Heart and Vascular Care, New York, NY; 5University of Colorado School of Medicine, Aurora, CO; 6Ochsner Clinic Foundation, New Orleans, LA; 7Ohio State University Medical Center, Columbus, OH; 8Duke University Medical Center, Durham, NC; 9University of Chicago School of Medicine and Medical Center, Chicago, IL; 10Advocate Christ Medical Center, Oak Lawn, IL; 11 Abbott, Abbott Park, IL; and the 12Integris Baptist Medical Center, Oklahoma City, OK. Purpose: The HeartMate 3 (HM3) Left Ventricular Assist System is a fully magnetically levitated, centrifugal, continuous-flow pump. In the MOMENTUM 3 trial, the HM3 apical cuff could be attached with two different Methods: Cut then Sew or Sew then Cut. This analysis describes the surgical techniques used in the trial and evaluates their impact on outcomes. Methods: 189 patients in the Long Term (LT) cohort were implanted with the HM3 pump. Patients were divided into groups based on the technique used to attach the apical cuff at implant. Survival and adverse events at 2 years of follow-up were compared between the groups. The burden of hemocompatibility related adverse events (HRAE) was evaluated with a previously defined hemocompatibility score (Mehra. Eur Heart J. 2017). Continuous and categorical data were compared with the Wilcoxon rank sum and chi-square tests. The log-rank test was used to compare survival. This analysis will be updated to the 515 patients implanted with HM3 in the Full Cohort, which will be available in March 2019. Results: 189 patients were implanted with HM3 by 68 surgeons at 52 centers. The median implant and bypass times were 261 and 83 minutes respectively. The majority of implants used the Cut then Sew apical attachment method (64%), true apical inflow cannula insertion (79%), silicone to skin driveline interface (90%), and right-sided driveline exit (54%). Cut
170 Poor Left Ventricular Unloading is Associated with Increased Mortality after Continuous Flow Left Ventricular Assist Device Implantation V. Maharaj,1 R. Cogswell,1 J. Schultz,1 R. John,2 C. Martin,1 T. Thenappan,1 and T. Alexy.1 1Division of Cardiology, University of Minnesota Medical Center, Minneapolis, MN; and the 2Division of Cardiothoracic Surgery, University of Minnesota Medical Center, Minneapolis, MN. Purpose: The role of routine right heart catheterization (RHC) to evaluate for left ventricular (LV) unloading remains unclear in patients with continuous flow left ventricular assist devices (CF-LVAD). We hypothesized that persistently elevated pulmonary capillary wedge pressure (PCWP) would be associated with increased mortality on CF-LVAD support. Methods: A single center continuous flow LVAD cohort (n=451) was queried for patients with follow-up RHC data at 6 months +/- 3 months (n=179). To determine the relationship between follow-up PCWP and mortality, a multivariable cox regression analysis was performed. Results: The mean age of the study cohort was 57§13 years. 79% (141/ 179) were males, 56% (101/179) had ischemic cardiomyopathy and 74% (133/179) were designated bridge to transplant (BTT). The median followup time on LVAD support after RHC was 4.4 years. The only pre-implant variables that were associated with elevated PCWP in the multivariate analysis were renal function and BMI (each 2.5 unit increase in BMI was associated with an adjusted 0.6 mmHg increase in follow-up PCWP, 95% CI 0.2-0.9 mmHg, p=0.004; each 0.5 mg/dL increase in creatinine was associated with a 1.2 mmHg increase in follow-up PCWP, 95% CI 0.4-2.1, p=0.003). In the final multivariate models, each 5 mmHg increase in PCWP at the time of RHC was associated with a 22% increase in the hazards rate of death during follow-up (adjusted HR 1.2, 95% CI 1.01-1.47, p=0.039). All models were adjusted for age, sex, INTERMACS profile, body mass index, bridge to transplant status and renal function. Conclusion: Incomplete LV unloading following CF-LVAD implantation is associated with increased all-cause mortality. Our results emphasize the importance of invasive hemodynamic optimization in this patient population. Further studies are warranted to determine the optimal filling pressures in patients with CF-LVAD.
The Journal of Heart and Lung Transplantation, Vol 38, No 4S, April 2019
New York, NY; 3Northwestern University, Chicago, IL; 4University of Utah, Salt Lake City, UT; and the 5Stanford University, Palo Alto, CA. Summary of Objectives: Ramp tests are used to optimize left ventricular assist device (LVAD) speed and tailor medical therapy. The addition of invasive hemodynamics to the ramp test has the potential to provide further information that will improve patient management. The aim of this study is to investigate the effects of a hemodynamic-guided approach to LVAD management on clinical outcomes, including exercise capacity and quality of life measures. Methods: RAMP-IT-UP is a multi-center, randomized trial comparing two management strategies for LVAD patients: a hemodynamic approach employing a hemodynamic ramp study to optimize LVAD speed and medical therapy (HR arm) and a standard of care approach employing transthoracic echocardiography (TTE) for optimization of LVAD speed and medical therapy (TTE arm). This study enrolled 41 patients (22 in HR arm, 19 in TTE arm) who had an HVAD LVAD and were 1-3 months postimplantation. All patients will be followed for six months after enrollment. Primary endpoints are changes in the 6-minute walk test, New York Heart Association Class and Kansas City Cardiomyopathy Questionnaire score. Exploratory endpoints will include the incidence of clinical events (mortality, heart failure admission, arrhythmias, gastrointestinal bleeding, stroke, pump thrombosis, aortic insufficiency and driveline infection). The analysis will include 6-month results for the full study cohort. The last patient was enrolled in September 2018, and will complete follow-up in March 2019. Endpoints: This is the first randomized study of two different clinical management strategies for chronic LVAD patients. This study will evaluate the benefits of a hemodynamic-guided approach on quality of life and outcomes of LVAD patients. (Funded by Medtronic; ClinicalTrials.gov Number, NCT03021239)
then Sew was associated with longer median bypass times when compared to Sew then Cut (86 vs 77.5 minutes, p = 0.033). In the LT Cohort, there were no significant differences in 2-year survival between the groups (logrank P=0.16). However, there was a trend for Cut then Sew to have a higher risk of stroke compared to Sew then Cut (Figure). Patients implanted with Cut then Sew vs Sew then Cut were also more likely to have a hemocompatibility score>1 (27% vs 15%, p=0.048). Conclusion: We demonstrate that the Cut then Sew method used additional bypass time and may confer a higher stroke risk and HRAE net burden compared to Sew then Cut pump implantation technique.
169 HeartMate 3 Surgical Implant Technique and Outcomes in the MOMENTUM 3 Trial C. Salerno,1 Y. Naka,2 S.C. Silvestry,3 D.J. Goldstein,4 J.C. Cleveland,5 A. Bansal,6 N.A. Mokadam,7 J.N. Schroder,8 V. Jeevanandam,9 A.J. Tatooles,10 J. Chuang,11 and J.W. Long.12 1St. Vincent Heart Center, Indianapolis, IN; 2Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital, New York, NY; 3Florida Hospital, Orlando, FL; 4Montefiore Einstein Center for Heart and Vascular Care, New York, NY; 5University of Colorado School of Medicine, Aurora, CO; 6Ochsner Clinic Foundation, New Orleans, LA; 7Ohio State University Medical Center, Columbus, OH; 8Duke University Medical Center, Durham, NC; 9University of Chicago School of Medicine and Medical Center, Chicago, IL; 10Advocate Christ Medical Center, Oak Lawn, IL; 11 Abbott, Abbott Park, IL; and the 12Integris Baptist Medical Center, Oklahoma City, OK. Purpose: The HeartMate 3 (HM3) Left Ventricular Assist System is a fully magnetically levitated, centrifugal, continuous-flow pump. In the MOMENTUM 3 trial, the HM3 apical cuff could be attached with two different Methods: Cut then Sew or Sew then Cut. This analysis describes the surgical techniques used in the trial and evaluates their impact on outcomes. Methods: 189 patients in the Long Term (LT) cohort were implanted with the HM3 pump. Patients were divided into groups based on the technique used to attach the apical cuff at implant. Survival and adverse events at 2 years of follow-up were compared between the groups. The burden of hemocompatibility related adverse events (HRAE) was evaluated with a previously defined hemocompatibility score (Mehra. Eur Heart J. 2017). Continuous and categorical data were compared with the Wilcoxon rank sum and chi-square tests. The log-rank test was used to compare survival. This analysis will be updated to the 515 patients implanted with HM3 in the Full Cohort, which will be available in March 2019. Results: 189 patients were implanted with HM3 by 68 surgeons at 52 centers. The median implant and bypass times were 261 and 83 minutes respectively. The majority of implants used the Cut then Sew apical attachment method (64%), true apical inflow cannula insertion (79%), silicone to skin driveline interface (90%), and right-sided driveline exit (54%). Cut
170 Poor Left Ventricular Unloading is Associated with Increased Mortality after Continuous Flow Left Ventricular Assist Device Implantation V. Maharaj,1 R. Cogswell,1 J. Schultz,1 R. John,2 C. Martin,1 T. Thenappan,1 and T. Alexy.1 1Division of Cardiology, University of Minnesota Medical Center, Minneapolis, MN; and the 2Division of Cardiothoracic Surgery, University of Minnesota Medical Center, Minneapolis, MN. Purpose: The role of routine right heart catheterization (RHC) to evaluate for left ventricular (LV) unloading remains unclear in patients with continuous flow left ventricular assist devices (CF-LVAD). We hypothesized that persistently elevated pulmonary capillary wedge pressure (PCWP) would be associated with increased mortality on CF-LVAD support. Methods: A single center continuous flow LVAD cohort (n=451) was queried for patients with follow-up RHC data at 6 months +/- 3 months (n=179). To determine the relationship between follow-up PCWP and mortality, a multivariable cox regression analysis was performed. Results: The mean age of the study cohort was 57§13 years. 79% (141/ 179) were males, 56% (101/179) had ischemic cardiomyopathy and 74% (133/179) were designated bridge to transplant (BTT). The median followup time on LVAD support after RHC was 4.4 years. The only pre-implant variables that were associated with elevated PCWP in the multivariate analysis were renal function and BMI (each 2.5 unit increase in BMI was associated with an adjusted 0.6 mmHg increase in follow-up PCWP, 95% CI 0.2-0.9 mmHg, p=0.004; each 0.5 mg/dL increase in creatinine was associated with a 1.2 mmHg increase in follow-up PCWP, 95% CI 0.4-2.1, p=0.003). In the final multivariate models, each 5 mmHg increase in PCWP at the time of RHC was associated with a 22% increase in the hazards rate of death during follow-up (adjusted HR 1.2, 95% CI 1.01-1.47, p=0.039). All models were adjusted for age, sex, INTERMACS profile, body mass index, bridge to transplant status and renal function. Conclusion: Incomplete LV unloading following CF-LVAD implantation is associated with increased all-cause mortality. Our results emphasize the importance of invasive hemodynamic optimization in this patient population. Further studies are warranted to determine the optimal filling pressures in patients with CF-LVAD.