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Revisiting the Achilles Heel of Exercise Capacity in Continuous Flow LVAD Patients Using Invasive Exercise Hemodynamics
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Journal of Cardiac Failure Vol. 24 No. 8S August 2018
302 Complete Versus Partial LV Unloading after LVAD Implantation and Association with Outcomes Antonio Duran, Imad Hussain, Alejandro R. Trevino, M. Ahraz Hussain, Ana S. CruzSolbes, Ashrith Guha, Arvind Bhimaraj, Barry Trachtenberg, Myung H. Park, Jerry Estep; Houston Methodist Hospital, Houston, TX Background: LVAD implantation improves survival in end-stage heart failure (HF) patients. It is unclear at this time whether the goal of partial or complete left ventricle (LV) unloading is the best long-term strategy to maintain favorable outcomes especially when it relates to patients who received LVAD as destination therapy. Methods: We conducted a retrospective analysis of end-stage HF patients who underwent continuous-flow LVAD implantation and subsequent right heart catheterization (RHC) to determine partial or complete LV unloading using invasive hemodynamics. Complete LV unloading was defined as cardiac index (CI) > 2.2 and pulmonary capillary wedge pressure (PCWP) <15 mmHg. One-year outcomes including mortality and hospital readmissions were compared between the two groups after index RHC. Results: Our sample size included 142 patients. Mean age 57.4 (range 25-79), 75.5% of male gender and 55% had an ischemic etiology of HF. Complete LV unloading was seen in 52 (36.6%) patients compared to 90 (63.4%) patients with partial LV unloading. There was a trend towards worse outcomes (mortality and HF readmission) in the group with partial LV unloading, however, did not reach statistical significance (Table 1). Discussion: Although there was a trend towards worse 1-year outcomes in patients with partial LV unloading, this did not reach statistical significance. Our institution uses invasive hemodynamics based on RHC for LVAD speed optimization and alterations in LVAD speed done at the time of RHC may potentially have played a role in influencing outcomes of the partially unloaded LV group and hence not met statistical significance. Best long-term strategy for LV unloading remains unclear at this time and further studies are needed to guide management to maintain favorable long-term outcomes.
1-yr mortality from RHC - N(%) All cause readmission 1-yr from RHC - N(%) HF readmission -1 - yr from RHC - N(%)
Case Age Pump 1 2 3
44 34 52
Speed rpm CMO
HVAD 2700 HM 3 6000 HM 2 9400
AV LVDD LVSD TAPSE opens AI MR cm cm mm BB
ICMO 0 NICMO 0 ICMO 0
1 1.5 5.4 0 0 4.6 0.5 0 4
5.3 3.4 2.8
0.6 1.5 1.4
0 Y Y
Figure 1. Graphs displaying Fick cardiac output and pulmonary capillary wedge pressures during iCPEX. In all 3 cases there was a modest increase in cardiac output, with linear non physiological increase in pulmonary capillary wedge pressure.
304 Neither Time in Therapeutic Range nor Most Recent International Normalized Ratio (INR) Correlate with Adverse Events in Patients Supported by Continuous-Flow Left Ventricular Assist Devices Sangjin Lee1, Jessica Parker1, Katy B. Wachter1, Jennifer K. McDermott1, Theodore J. Boeve1, Marzia Leacche1, Shakil Chowdhury2, Michael G. Dickinson1; 1Spectrum Health, Grand Rapids, MI; 2Michigan State University, Grand Rapids, MI
Table 1. Complete LV unloading and its association with outcomes.
Outcome
Table 1. Baseline demographics.
Complete LV unloading N=52
Partial LV unloading N=90
p-value
7 (13.4%) 32 (61.5%)
18(20%) 60 (66.6%)
0.324 0.586
8 (15.4%)
22 (24%)
0.203
303 Revisiting the Achilles Heel of Exercise Capacity in Continuous Flow LVAD Patients Using Invasive Exercise Hemodynamics Omaima Ali, Virginia Gonzalez, Joshua Cysyk, Robert Donovan, John Boehmer; Penn State Hershey Med Center, Hershey, PA Background: Continuous flow left ventricular assist devices (cfLVADs) have greatly improved survival and quality of life for patients with end-stage heart failure. However, exercise capacity remains poor and little is known about hemodynamics during exercise. We describe observations from invasive cardiopulmonary exercise (iCPEX) tests in 3 patients with continuous flow LVADs. Methods: Three patients with cfLVADs (HeartMate II, HeartMate 3 and HeartWare HVAD) underwent iCPEX with a pulmonary artery catheter placed via the right internal jugular vein and using an exercise bicycle protocol with a 10 Watt ramp. Ventilatory measurements were made with a Sensormedics CPX testing unit (Sensormedics, VMAX Encore 29C). One subject also had a radial arterial line for blood pressure monitoring. Results: The peak oxygen consumption averaged 1.03 § 0.32 L/min (36.8% mean max. predicated) or 9.5§ 1.7 mL/kg/min. Respiratory quotient averaged 1.2 §0.1. With exercise, cardiac output increased modestly from 7.8 § 2.8 to 10.8 § 2.6 L/min. There was a progressive increase in pulmonary capillary wedge pressure (PCW) in all patients, from 25 § 12 to 34 § 13 mmHg. Right atrial pressure changed minimally in 2 subjects (20 to 24 mmHg and 6 to 10 mmHg), while there was a rise in RA pressure towards the end of exercise in one subject with known poor right ventricular function (14 to 28 mmHg). In the subject monitored with an arterial line, there was a rise in blood pressure from 94 to 106 mmHg mean and an increase in pulse pressure from 18 to 54 mmHg. Conclusion: Hemodynamics during exercise in patients with cfLVADs demonstrates a modest increase in cardiac output that is associated with a nonphysiologic increase PCW. Peak oxygen consumption was well below predicted. The rise in PCW with only a modest increase in exercise cardiac output raise the question of whether automated circulatory control to increase pump performance with exercise could lead to improved exercise capacity in cfLVAD patients.Figure 1
Introduction: Continuous-Flow Left Ventricular Assist Devices (CFLVADs) improve mortality and quality of life in end-stage cardiomyopathy patients. Adverse events however remain high. Hypothesis: We hypothesize time in therapeutic range (TTR) correlates with adverse events compared to most recent INR. Methods: The study group comprised of patients who suffered suspected/confirmed pump thrombosis, stroke or major bleeding event as defined by INTERMACS after 1 month at home with 1 month of INR values. Controls (CON) had at least 3 months of INR values after being home for 1 month from LVAD implant and who did not experience any adverse events (AE). Standard statistical methods were employed as indicated: Chi-square, Fishers Exact test, two-sample t-test, Wilcoxon Rank sum test, One way ANOVA and Kruskal Wallis Analysis. Patients with multiple adverse events were excluded. Results: From June 2010 - December 2016, 132 patients underwent CFLVAD implantation at our institution who met entry criteria. Mean age was 57§13 yrs and 106 (80%) were male. Seventy-seven (58%) were implanted as bridge to transplant (BTT). There was no statistically significant difference in TTR (p=0.39, Table 1) or most recent INR (p=0.33, Table 2) prior to AE. Patients who suffered AEs were older than those who did not (59.3§ 12 vs. 54.4§14.3 yrs, p=0.04). There was no association of AEs when stratified by gender, LVAD indication, LVAD device type, race, BMI or hospital length of stay (p=ns). Conclusions: Neither time in therapeutic range nor most recent INR correlated with major bleeding, neurological dysfunction or pump thrombosis in CFLVAD patients in this analysis. Further investigation beyond strict INR control and anticoagulation is needed to reduce adverse events in this patient population. Table 1. Time in Therapeutic Range.
Type of Event
N (Obs) Mean (%) Std Dev (%) Median (%) Q1 (%) Q3 (%)
No Event Bleeding Neuro Dysfunction Pump Thrombosis
58 72 15 31
40.2 41.3 41.48 45.48
16.9 19.8 23.03 17.63
36.75 41.7 39.6 46.2
28.5 29.2 23.8 30.4
55.9 54.35 56.2 56.7
Table 2. INR at Event.
Type of Event
N (Obs)
Mean
Std Dev
Median
Q1
Q3
No Event Bleeding Neuro Dysfunction Pump Thrombosis
58 72 15 31
2.9 2.89 2.36
1.88 2.68 0.94
2.4 2.2 2.10
1.9 1.7 1.8
3.25 3.00 2.6
Journal of Cardiac Failure Vol. 24 No. 8S August 2018
302 Complete Versus Partial LV Unloading after LVAD Implantation and Association with Outcomes Antonio Duran, Imad Hussain, Alejandro R. Trevino, M. Ahraz Hussain, Ana S. CruzSolbes, Ashrith Guha, Arvind Bhimaraj, Barry Trachtenberg, Myung H. Park, Jerry Estep; Houston Methodist Hospital, Houston, TX Background: LVAD implantation improves survival in end-stage heart failure (HF) patients. It is unclear at this time whether the goal of partial or complete left ventricle (LV) unloading is the best long-term strategy to maintain favorable outcomes especially when it relates to patients who received LVAD as destination therapy. Methods: We conducted a retrospective analysis of end-stage HF patients who underwent continuous-flow LVAD implantation and subsequent right heart catheterization (RHC) to determine partial or complete LV unloading using invasive hemodynamics. Complete LV unloading was defined as cardiac index (CI) > 2.2 and pulmonary capillary wedge pressure (PCWP) <15 mmHg. One-year outcomes including mortality and hospital readmissions were compared between the two groups after index RHC. Results: Our sample size included 142 patients. Mean age 57.4 (range 25-79), 75.5% of male gender and 55% had an ischemic etiology of HF. Complete LV unloading was seen in 52 (36.6%) patients compared to 90 (63.4%) patients with partial LV unloading. There was a trend towards worse outcomes (mortality and HF readmission) in the group with partial LV unloading, however, did not reach statistical significance (Table 1). Discussion: Although there was a trend towards worse 1-year outcomes in patients with partial LV unloading, this did not reach statistical significance. Our institution uses invasive hemodynamics based on RHC for LVAD speed optimization and alterations in LVAD speed done at the time of RHC may potentially have played a role in influencing outcomes of the partially unloaded LV group and hence not met statistical significance. Best long-term strategy for LV unloading remains unclear at this time and further studies are needed to guide management to maintain favorable long-term outcomes.
1-yr mortality from RHC - N(%) All cause readmission 1-yr from RHC - N(%) HF readmission -1 - yr from RHC - N(%)
Case Age Pump 1 2 3
44 34 52
Speed rpm CMO
HVAD 2700 HM 3 6000 HM 2 9400
AV LVDD LVSD TAPSE opens AI MR cm cm mm BB
ICMO 0 NICMO 0 ICMO 0
1 1.5 5.4 0 0 4.6 0.5 0 4
5.3 3.4 2.8
0.6 1.5 1.4
0 Y Y
Figure 1. Graphs displaying Fick cardiac output and pulmonary capillary wedge pressures during iCPEX. In all 3 cases there was a modest increase in cardiac output, with linear non physiological increase in pulmonary capillary wedge pressure.
304 Neither Time in Therapeutic Range nor Most Recent International Normalized Ratio (INR) Correlate with Adverse Events in Patients Supported by Continuous-Flow Left Ventricular Assist Devices Sangjin Lee1, Jessica Parker1, Katy B. Wachter1, Jennifer K. McDermott1, Theodore J. Boeve1, Marzia Leacche1, Shakil Chowdhury2, Michael G. Dickinson1; 1Spectrum Health, Grand Rapids, MI; 2Michigan State University, Grand Rapids, MI
Table 1. Complete LV unloading and its association with outcomes.
Outcome
Table 1. Baseline demographics.
Complete LV unloading N=52
Partial LV unloading N=90
p-value
7 (13.4%) 32 (61.5%)
18(20%) 60 (66.6%)
0.324 0.586
8 (15.4%)
22 (24%)
0.203
303 Revisiting the Achilles Heel of Exercise Capacity in Continuous Flow LVAD Patients Using Invasive Exercise Hemodynamics Omaima Ali, Virginia Gonzalez, Joshua Cysyk, Robert Donovan, John Boehmer; Penn State Hershey Med Center, Hershey, PA Background: Continuous flow left ventricular assist devices (cfLVADs) have greatly improved survival and quality of life for patients with end-stage heart failure. However, exercise capacity remains poor and little is known about hemodynamics during exercise. We describe observations from invasive cardiopulmonary exercise (iCPEX) tests in 3 patients with continuous flow LVADs. Methods: Three patients with cfLVADs (HeartMate II, HeartMate 3 and HeartWare HVAD) underwent iCPEX with a pulmonary artery catheter placed via the right internal jugular vein and using an exercise bicycle protocol with a 10 Watt ramp. Ventilatory measurements were made with a Sensormedics CPX testing unit (Sensormedics, VMAX Encore 29C). One subject also had a radial arterial line for blood pressure monitoring. Results: The peak oxygen consumption averaged 1.03 § 0.32 L/min (36.8% mean max. predicated) or 9.5§ 1.7 mL/kg/min. Respiratory quotient averaged 1.2 §0.1. With exercise, cardiac output increased modestly from 7.8 § 2.8 to 10.8 § 2.6 L/min. There was a progressive increase in pulmonary capillary wedge pressure (PCW) in all patients, from 25 § 12 to 34 § 13 mmHg. Right atrial pressure changed minimally in 2 subjects (20 to 24 mmHg and 6 to 10 mmHg), while there was a rise in RA pressure towards the end of exercise in one subject with known poor right ventricular function (14 to 28 mmHg). In the subject monitored with an arterial line, there was a rise in blood pressure from 94 to 106 mmHg mean and an increase in pulse pressure from 18 to 54 mmHg. Conclusion: Hemodynamics during exercise in patients with cfLVADs demonstrates a modest increase in cardiac output that is associated with a nonphysiologic increase PCW. Peak oxygen consumption was well below predicted. The rise in PCW with only a modest increase in exercise cardiac output raise the question of whether automated circulatory control to increase pump performance with exercise could lead to improved exercise capacity in cfLVAD patients.Figure 1
Introduction: Continuous-Flow Left Ventricular Assist Devices (CFLVADs) improve mortality and quality of life in end-stage cardiomyopathy patients. Adverse events however remain high. Hypothesis: We hypothesize time in therapeutic range (TTR) correlates with adverse events compared to most recent INR. Methods: The study group comprised of patients who suffered suspected/confirmed pump thrombosis, stroke or major bleeding event as defined by INTERMACS after 1 month at home with 1 month of INR values. Controls (CON) had at least 3 months of INR values after being home for 1 month from LVAD implant and who did not experience any adverse events (AE). Standard statistical methods were employed as indicated: Chi-square, Fishers Exact test, two-sample t-test, Wilcoxon Rank sum test, One way ANOVA and Kruskal Wallis Analysis. Patients with multiple adverse events were excluded. Results: From June 2010 - December 2016, 132 patients underwent CFLVAD implantation at our institution who met entry criteria. Mean age was 57§13 yrs and 106 (80%) were male. Seventy-seven (58%) were implanted as bridge to transplant (BTT). There was no statistically significant difference in TTR (p=0.39, Table 1) or most recent INR (p=0.33, Table 2) prior to AE. Patients who suffered AEs were older than those who did not (59.3§ 12 vs. 54.4§14.3 yrs, p=0.04). There was no association of AEs when stratified by gender, LVAD indication, LVAD device type, race, BMI or hospital length of stay (p=ns). Conclusions: Neither time in therapeutic range nor most recent INR correlated with major bleeding, neurological dysfunction or pump thrombosis in CFLVAD patients in this analysis. Further investigation beyond strict INR control and anticoagulation is needed to reduce adverse events in this patient population. Table 1. Time in Therapeutic Range.
Type of Event
N (Obs) Mean (%) Std Dev (%) Median (%) Q1 (%) Q3 (%)
No Event Bleeding Neuro Dysfunction Pump Thrombosis
58 72 15 31
40.2 41.3 41.48 45.48
16.9 19.8 23.03 17.63
36.75 41.7 39.6 46.2
28.5 29.2 23.8 30.4
55.9 54.35 56.2 56.7
Table 2. INR at Event.
Type of Event
N (Obs)
Mean
Std Dev
Median
Q1
Q3
No Event Bleeding Neuro Dysfunction Pump Thrombosis
58 72 15 31
2.9 2.89 2.36
1.88 2.68 0.94
2.4 2.2 2.10
1.9 1.7 1.8
3.25 3.00 2.6