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5: Gastrointestinal Bleeding Complications in Continuous Flow LVAD Patients – Is It Device Specific?
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The Journal of Heart and Lung Transplantation, Vol 29, No 2S, February 2010
noted in the TVR Gp. One Pt in TVR and 3 Pts in NTVR Gp required right VAD (p⫽0.6). There was no significant difference in short or long term mortality between these 2 Gps.[figure1]
Conclusions: TVR for ⱖ3⫹ TR prolonged operative time and showed similar outcomes compared to LVAD implantation alone. Therefore, TVR may not be necessary at the time of LVAD implantation. 4 Less Frequency of Aortic Valve Opening and Continuous Flow Device Are Risk Factors for Late Onset of Aortic Regurgitation in Patients with Left Ventricular Assist Device M. Hatano,1 K. Kinugawa,1 T. Shiga,1 A. Yao,1 Y. Hirata,1 T. Nishimura,2 S. Kyo,2 M. Ono,3 R. Nagai.1 1The University of Tokyo, Tokyo, Japan; 2The University of Tokyo, Tokyo, Japan; 3The University of Tokyo, Tokyo, Japan. Purpose: Late development of aortic regurgitation (AR) is often observed during long-term support with left ventricular assist device (LVAD), and has previously been reported to correlate with less frequent opening and commissural fusion of aortic valve (AV). However, there has been no study comparing different types of device flow. The purpose of this study is to elucidate risk factors correlating with the development of AR. Methods and Materials: Thirty patients receiving LVAD (duration 5-37 months) without abnormalities in native AV were enrolled (pulsatile flow: 73%, continuous flow: 27%). Frequency of AV opening and grade of AR were evaluated by the most recent echocardiography during LVAD support. Results: None of patients had AR ⱖgrade 1 preoperatively. During LVAD support AR ⱖgrade 1 developed in 9 patients. The grade of AR negatively correlated with frequency of AV opening (r⫽⫺0.617, p⬍0.001). BNP levels were significantly higher in the patients who developed AR ⱖgrade 1 (306⫾296 vs 98⫾96 pg/mL, p⫽0.03). The grade of AR not at all correlated with duration of LVAD assist or LV ejection fraction during support. Patients with continuous flow device significantly developed greater AR (p⫽0.007) and had relatively less frequency of AV opening. In one patient who developed grade 2 AR, we observed aortic commissural fusion at the time of heart transplantation. Conclusions: Less frequency of AV opening appears to be a predictive factor for the late onset of AR. Continuous flow may totally deprive a chance for AV opening in the case of severely damaged LV, which can only develop systolic pressure well lower than mostly static aortic pressure. Considering the higher BNP levels, AR should be a disadvantage toward bridge-to-recovery. Further investigation is required if any intervention to force opening AV prevents the development of AR. 5 Gastrointestinal Bleeding Complications in Continuous Flow LVAD Patients – Is It Device Specific? I.-W. Wang,1 T. Guthrie,1 G.A. Ewald,2 E.M. Geltman,2 S. Joseph,2 N. Moazami.1 1Washington University School of Medicine, Saint Louis, MO; 2Washington University School of Medicine, Saint Louis, MO.
Purpose: Gastrointestinal bleeding (GIB) has been reported annectodally with increasing frequency in patients with continuous flow (CF) LVADs. This adverse event was not commonly noted in pulsatile LVADs. We examined GIB in our CF LVAD patients to identify potential variables, including device selection. Methods and Materials: A retrospective review of CF LVADs implanted at a single institution from June 2005 to Sept 2009 was performed. An analysis of demographics, blood product transfusion rates, and selected outcomes was performed comparing GIB and non-GIB patients. Results: 77 CF LVADs were implanted: HeartMate-II (HM-II, n⫽61) and Ventrassist (n⫽16). Post-operative anticoagulation/antiplatelet regimens were the same for both. GIB occurred in 13 (17%) patients. Compared to non-GIB patients, GIB patients were older (mean age 60.5 vs. 49.0 years, p⫽0.005). They were more likely to have prior sternotomy (54% vs 25%, p⫽0.051) and to be intubated preoperatively (38% vs. 12%, p⫽0.038). Requirements for postoperative blood product transfusion were higher in GIB than non-GIB patients: packed red blood cells: mean 23.7 vs. 8.5units, p⬍0.001; platelets: mean 3.4 vs. 1.4 units, p⫽0.036. Perioperative morbidity and mortality were not different except for longer median ventilator support (184 vs. 50 hours, p⫽0.001) and longer median hospital stays (37 vs. 19 days, p⬍0.001) for GIB patients. All 13 GIB patients were implanted with HM-II (21%). The mean time from device implantation to onset of initial GIB episode was 31 days. Eight (62%) GIB patients had their initial bleeding event during the primary LVAD implantation hospitalization; five (38%) patients required subsequent hospital readmission for GIB. Conclusions: GIB is a significant morbidity in CF LVAD patients, occuring in ⬎15% of our patients in implanted in the past 4 years. 21% of HM-II patients had GIB while no GIB occurred in Ventrassist patients. The hydrodynamics of axial versus centrifugal flow or the specific differences in the mode of operation may contribute to the higher incidence of GIB in the HM-II. 6 Neurological Adverse Events (NAEs) and Proposed Mechanisms in a Single Center Experience with Continuous-Flow Left Ventricular Assist Devices (LVADs) C.M. Halley,1 G.V. Gonzalez-Stawinski,2 E.C. Chu,1 P.M. Eckman,1 N.S. Smedira,2 R.C. Starling,1 M.M. Mountis.1 1Cleveland Clinic Foundation, Cleveland, OH; 2Cleveland Clinic Foundation, Cleveland, OH. Purpose: To assess prevalence and mechanism of NAE in a population with continuous flow LVADs. Methods and Materials: 100 consecutive patients (px) who underwent left ventricular support with a Heartmate II device were evaluated Results: There were 24 NAEs in 17 px (82.3% male, age 51.8, median 178.0 days)- ischemic stroke (10%), intracranial hemorrhage (ICH)(6%), seizures (4%) and TIA (3%) (Table 1). Ischemic stroke was associated with acute MI and ECMO support (both p ⫽ 0.004, RR 3.3 [1.7-6.5]) and were less likely to be anticoagulated (p⫽ 0.03, OR 0.1 [0.02-0.92]). Primary intracerebral bleed occurred in only 2 cases. ICH was associated with a history of AF (p⫽0.01) and with heparin use (p⫽0.04, RR 4.8 [1.1-20.7]). All seizures were secondary to a previous neurological insult. There were 5 deaths directly related to a NAE. Overall survival was worse following a neurological event, p ⫽0.04. Heparin use at the time of event was a predictor of mortality, p value ⫽ 0.02, RR 18.7 [95% CI 1.7 ⫺413.6].[table1]
Table 1 Overall
⬎ 30 days
0-30 days
Event
Px (%)
Event rate (EV) per PYⴱ
Ischemic stroke ● LVAD related ICH ● Primary intracerebral bleed ● Traumatic ● Secondary hemorrhagic conversion Seizure TIA
10 (10%) 4 (4%) 6 (6%) 2 (2%) 2 (2%) 2 (2%)
0.26 0.12 0.16 0.05 0.05 0.05
6 (6%) 1 (1%) 2 (2%) 1 (1%) 1 (1%) 0 (0%)
0.78 0.13 0.26 0.13 0 (0% ) 0
4 (4%) 3 (3 %) 4 (4%) 1 (1%) 1 (1%) 2 (2%)
0.13 0.01 0.13 0.03 0.03 0.07
4 (4%) 3 (3%)
0.12 0.08
1 (1%) 2 (2%)
0.13 0.26
3 (3%) 1 (1%)
0.01 0.03
ⴱ
patient year
Px (%)
EV per PY
Px (%)
EV per PY
The Journal of Heart and Lung Transplantation, Vol 29, No 2S, February 2010
noted in the TVR Gp. One Pt in TVR and 3 Pts in NTVR Gp required right VAD (p⫽0.6). There was no significant difference in short or long term mortality between these 2 Gps.[figure1]
Conclusions: TVR for ⱖ3⫹ TR prolonged operative time and showed similar outcomes compared to LVAD implantation alone. Therefore, TVR may not be necessary at the time of LVAD implantation. 4 Less Frequency of Aortic Valve Opening and Continuous Flow Device Are Risk Factors for Late Onset of Aortic Regurgitation in Patients with Left Ventricular Assist Device M. Hatano,1 K. Kinugawa,1 T. Shiga,1 A. Yao,1 Y. Hirata,1 T. Nishimura,2 S. Kyo,2 M. Ono,3 R. Nagai.1 1The University of Tokyo, Tokyo, Japan; 2The University of Tokyo, Tokyo, Japan; 3The University of Tokyo, Tokyo, Japan. Purpose: Late development of aortic regurgitation (AR) is often observed during long-term support with left ventricular assist device (LVAD), and has previously been reported to correlate with less frequent opening and commissural fusion of aortic valve (AV). However, there has been no study comparing different types of device flow. The purpose of this study is to elucidate risk factors correlating with the development of AR. Methods and Materials: Thirty patients receiving LVAD (duration 5-37 months) without abnormalities in native AV were enrolled (pulsatile flow: 73%, continuous flow: 27%). Frequency of AV opening and grade of AR were evaluated by the most recent echocardiography during LVAD support. Results: None of patients had AR ⱖgrade 1 preoperatively. During LVAD support AR ⱖgrade 1 developed in 9 patients. The grade of AR negatively correlated with frequency of AV opening (r⫽⫺0.617, p⬍0.001). BNP levels were significantly higher in the patients who developed AR ⱖgrade 1 (306⫾296 vs 98⫾96 pg/mL, p⫽0.03). The grade of AR not at all correlated with duration of LVAD assist or LV ejection fraction during support. Patients with continuous flow device significantly developed greater AR (p⫽0.007) and had relatively less frequency of AV opening. In one patient who developed grade 2 AR, we observed aortic commissural fusion at the time of heart transplantation. Conclusions: Less frequency of AV opening appears to be a predictive factor for the late onset of AR. Continuous flow may totally deprive a chance for AV opening in the case of severely damaged LV, which can only develop systolic pressure well lower than mostly static aortic pressure. Considering the higher BNP levels, AR should be a disadvantage toward bridge-to-recovery. Further investigation is required if any intervention to force opening AV prevents the development of AR. 5 Gastrointestinal Bleeding Complications in Continuous Flow LVAD Patients – Is It Device Specific? I.-W. Wang,1 T. Guthrie,1 G.A. Ewald,2 E.M. Geltman,2 S. Joseph,2 N. Moazami.1 1Washington University School of Medicine, Saint Louis, MO; 2Washington University School of Medicine, Saint Louis, MO.
Purpose: Gastrointestinal bleeding (GIB) has been reported annectodally with increasing frequency in patients with continuous flow (CF) LVADs. This adverse event was not commonly noted in pulsatile LVADs. We examined GIB in our CF LVAD patients to identify potential variables, including device selection. Methods and Materials: A retrospective review of CF LVADs implanted at a single institution from June 2005 to Sept 2009 was performed. An analysis of demographics, blood product transfusion rates, and selected outcomes was performed comparing GIB and non-GIB patients. Results: 77 CF LVADs were implanted: HeartMate-II (HM-II, n⫽61) and Ventrassist (n⫽16). Post-operative anticoagulation/antiplatelet regimens were the same for both. GIB occurred in 13 (17%) patients. Compared to non-GIB patients, GIB patients were older (mean age 60.5 vs. 49.0 years, p⫽0.005). They were more likely to have prior sternotomy (54% vs 25%, p⫽0.051) and to be intubated preoperatively (38% vs. 12%, p⫽0.038). Requirements for postoperative blood product transfusion were higher in GIB than non-GIB patients: packed red blood cells: mean 23.7 vs. 8.5units, p⬍0.001; platelets: mean 3.4 vs. 1.4 units, p⫽0.036. Perioperative morbidity and mortality were not different except for longer median ventilator support (184 vs. 50 hours, p⫽0.001) and longer median hospital stays (37 vs. 19 days, p⬍0.001) for GIB patients. All 13 GIB patients were implanted with HM-II (21%). The mean time from device implantation to onset of initial GIB episode was 31 days. Eight (62%) GIB patients had their initial bleeding event during the primary LVAD implantation hospitalization; five (38%) patients required subsequent hospital readmission for GIB. Conclusions: GIB is a significant morbidity in CF LVAD patients, occuring in ⬎15% of our patients in implanted in the past 4 years. 21% of HM-II patients had GIB while no GIB occurred in Ventrassist patients. The hydrodynamics of axial versus centrifugal flow or the specific differences in the mode of operation may contribute to the higher incidence of GIB in the HM-II. 6 Neurological Adverse Events (NAEs) and Proposed Mechanisms in a Single Center Experience with Continuous-Flow Left Ventricular Assist Devices (LVADs) C.M. Halley,1 G.V. Gonzalez-Stawinski,2 E.C. Chu,1 P.M. Eckman,1 N.S. Smedira,2 R.C. Starling,1 M.M. Mountis.1 1Cleveland Clinic Foundation, Cleveland, OH; 2Cleveland Clinic Foundation, Cleveland, OH. Purpose: To assess prevalence and mechanism of NAE in a population with continuous flow LVADs. Methods and Materials: 100 consecutive patients (px) who underwent left ventricular support with a Heartmate II device were evaluated Results: There were 24 NAEs in 17 px (82.3% male, age 51.8, median 178.0 days)- ischemic stroke (10%), intracranial hemorrhage (ICH)(6%), seizures (4%) and TIA (3%) (Table 1). Ischemic stroke was associated with acute MI and ECMO support (both p ⫽ 0.004, RR 3.3 [1.7-6.5]) and were less likely to be anticoagulated (p⫽ 0.03, OR 0.1 [0.02-0.92]). Primary intracerebral bleed occurred in only 2 cases. ICH was associated with a history of AF (p⫽0.01) and with heparin use (p⫽0.04, RR 4.8 [1.1-20.7]). All seizures were secondary to a previous neurological insult. There were 5 deaths directly related to a NAE. Overall survival was worse following a neurological event, p ⫽0.04. Heparin use at the time of event was a predictor of mortality, p value ⫽ 0.02, RR 18.7 [95% CI 1.7 ⫺413.6].[table1]
Table 1 Overall
⬎ 30 days
0-30 days
Event
Px (%)
Event rate (EV) per PYⴱ
Ischemic stroke ● LVAD related ICH ● Primary intracerebral bleed ● Traumatic ● Secondary hemorrhagic conversion Seizure TIA
10 (10%) 4 (4%) 6 (6%) 2 (2%) 2 (2%) 2 (2%)
0.26 0.12 0.16 0.05 0.05 0.05
6 (6%) 1 (1%) 2 (2%) 1 (1%) 1 (1%) 0 (0%)
0.78 0.13 0.26 0.13 0 (0% ) 0
4 (4%) 3 (3 %) 4 (4%) 1 (1%) 1 (1%) 2 (2%)
0.13 0.01 0.13 0.03 0.03 0.07
4 (4%) 3 (3%)
0.12 0.08
1 (1%) 2 (2%)
0.13 0.26
3 (3%) 1 (1%)
0.01 0.03
ⴱ
patient year
Px (%)
EV per PY
Px (%)
EV per PY