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Durable LeftVentricular Assist Device Therapy to Reduce Transpulmonary Gradient in Adult Congenital Heart Disease to Facilitate Heart Transplant
S58
The Journal of Heart and Lung Transplantation, Vol 36, No 4S, April 2017
was no statistical difference in early postoperative outcomes between the two groups including length of ICU stay, prolonged intubation, pneumonia, acute kidney injury, and stroke. In-hospital mortality was 3.8 % in the scIABP group, and 8.5 % in the LVAD group (P = 0.256). There was no statistical difference in the incidence of primary graft dysfunction (scIABP 4.9 % vs LVAD 10.6 %, P = 0.260), or rejection (> grade 3A) (scIABP 17.7 % vs LVAD 22.2 %, P= 0.565). Kaplan-Meier analysis showed 1-year survival did not differ between the groups (IABP 88.6 % vs LVAD 85.0 %, P = 0.342). Conclusion: BTT with scIABP support was associated with shorter operative time, shorter cardiopulmonary bypass time, and fewer blood transfusions, compared to LVAD support. scIABP is a favorable method for bridge to transplant in selected patients who respond to counter-pulsation therapy. 1( 28) Device Exchange Is Superior to Medical Therapy for Treating Continuous-Flow Left Ventricular Assist Device Thrombosis H. Kitahara , C. Juricek, D. Onsager, J. Reikhelkar, G. Kim, N. Sarswat, S. Adatya, G. Sayer, N. Uriel, T. Song, V. Jeevanandam, T. Ota. Cardiac Surgery, The University of Chicago, Chicago, IL. Purpose: Device thrombosis is a significant adverse event of left ventricular assist device (LVAD) therapy. This study aimed to compare the outcome of patients diagnosed with device thrombosis who treated with early device exchange to patients treated with medical therapy. Methods: All patients implanted with LVAD (HeartMate II) between July 2008 and December 2015 were included in this analysis. Device thrombosis was diagnosed by combination of positive ramp test, elevated lactate dehydrogenase, high free plasma hemoglobin , hematuria and device power spike. Indication for surgical intervention included persistent device thrombosis refractory to medical therapy, end-organ impairment, and hemodynamic instability. Results: Among a total of 277 LVAD patients, 37 (13.4%) were diagnosed with a device thrombosis and medical therapy with heparin was initiated. Surgical device exchange was subsequently performed in 23 patients (ST group), and medical therapy was continued in 14 patients (MT group). Device thrombosis was diagnosed by combination of positive ramp test (52.8 %), elevated lactate dehydrogenase (81.1 %), high free plasma hemoglobin (87.1 %), hematuria (40.5 %), and device power spike (67.6 %). The mean interval from LVAD implantation to device thrombosis was 381.0 ± 404.3 days. There was no statistical difference in patients’ characteristics between the groups. In-hospital mortality was 4.3 % (1/23) in the ST group and 28.6 % (4/14) in the MT group (P= 0.037). Kaplan-Meier analysis showed that 1-year survival was significantly better in the ST group compared to the MT group (ST 74.0 % vs MT 30.1 %; log-rank 0.001), and that freedom from cerebrovascular accident at 1 year was greater in the ST group (ST 87.1 % vs MT 47.7 %; log-rank 0.004). Conclusion: Device exchange was associated with improved 1-year survival and fewer cerebrovascular adverse events compared to medical therapy. Aggressive surgical intervention should be recommended for LVAD patients with device thrombosis.
1( 29) Mechanical Circulatory Support for Patients in Cardiogenic Shock After Right Ventricular Infarction: A Single-Center Experience K. Patel , K. Takeda, L. Truby, C. Eckhardt, K. Ross, D. Karmpaliotis, Y. Naka, V.K. Topkara, M. Yuzefpolskaya, P.C. Colombo, A. Kirtane, H. Takayama, A.R. Garan. Columbia University, New York, NY. Purpose: Right ventricular infarction (RVI) with cardiogenic shock (CS) carries a high mortality despite early revascularization. The use of mechanical circulatory support (MCS) in these patients has not been well described. Methods: We retrospectively reviewed 117 patients at our center placed on MCS (extracorporeal membrane oxygenation [ECMO], percutaneous [p] RV-assist device [RVAD], or surgical [s]RVAD) after acute MI from 20072016 to identify those with predominantly RVI. Baseline characteristics, type of device used, and outcomes were studied. Results: Fourteen patients (12%) suffered predominantly RVI and progressed to CS requiring MCS. The RCA was infarcted in 13/14 of cases and 13/14 were emergently revascularized (71.4% PCI, 28.6% CABG). Prior to MCS, the mean cardiac index was 1.79±0.67 L/min/m2, CVP was 15.0±1.85 mmHg, PCWP was 16.5±3.39 mmHg, and pulmonary artery pulsatility index was 1.03±0.43. TTE showed moderate-severe RV dysfunction in 92.9% and mean LVEF 41.7±14.3%. A pMCS device was used in 9 patients (6 ECMO, 3 pRVAD) and sRVAD in 5. Patients remained on MCS for a mean of 24 days (13±7days pRVAD vs. 44±23days sRVAD; p= 0.003); 12 (85.7%) patients survived to hospital discharge (88.9% pRVAD vs. 80.0% sRVAD). When compared to those with predominantly LV infarction (LVI) requiring MCS, patients with a RVI had similar age (61.7±12.3y RVI vs 59.3±11.3y LVI, p= 0.45) and degree of CS measured by cardiac power index (0.27±0.10 W/m2 RVI vs 0.23±0.21 W/m2 LVI, p= 0.64). However, RVI patients had a better 180days survival compared to LVI patients (84.4% RVI vs 48.6% LVI, p= 0.02, figure). Conclusion: In patients with RVI and CS, MCS use is associated with better than expected survival. Our findings indicate differences in the short-term recoverability of the right and left ventricle after AMI and severe CS requiring MCS.
1( 30) Durable LeftVentricular Assist Device Therapy to Reduce Transpulmonary Gradient in Adult Congenital Heart Disease to Facilitate Heart Transplant A. Woods , G. MacGowan, N. Robinson-Smith, L. Kenny, A. Hasan, S. Schueler. Cardiothoracic, Newcastle upon Tyne NHS Foundations Trust, Newcastle upon Tyne, United Kingdom. Purpose: Patients with Adult Congenital Heart Disease (ACHD) are often not eligible for heart only transplant due to high Trans Pulmonary Gradient (TPG). The introduction of durable Left Ventricular Assist Devices (LVAD) offers a new approach to make these highly complex patients transplantable. Methods: 15 patients with ACHD underwent LVAD implantation as either bridge to transplant or bridge to decision. All patients underwent right heart catheter prior to LVAD implant. Patients with a TPG ≥ 13 mmHg were
Abstracts S59 deemed unsuitable for heart only transplant. Pre and Post LVAD implant right heart catheters were reviewed. 11 Patients with a TPG of 13 or greater were deemed unsuitable for cardiac transplant (see Table 1). Exclusions from data: 2 died on LVAD before TPG could be rechecked: one awaiting post implant TPG leaving 8 patients with complete follow up. Results: Results are summarized in table 1. The diagnoses were as follows: Transposition of the Great Arteries (n= 6); coarctation of the aorta (n= 1); prior VSD closure (n= 1). Mean age of 33 and 13% women. TPG reduced after LVAD implant in 7 patients making them suitable for heart only transplant. 4 of these patients went on to have a transplant while 3 remain on LVAD support on the active waiting list. 1 patient with persistent high TPG went on to have a heart lung transplant. Patients spent an average time of 555 days (range 281-904) on LVAD support before their TPG was reduced to a level suitable for transplant Table 1.
TPG pre-LVAD (mmHg)
TPG post-LVAD (mmHg)
Time on LVAD before TPG suitable for listing (days)
13 21 18
6 8 19
643 747 0
15 17 16 20 13
4 10 12 11 6
249 454 904 610 281
Outcome Transplanted Transplanted Transplanted Heart and Lung Block Transplanted Transplanted on support on support on support
Conclusion: Patients with ACHD and high TPG can be successfully bridged with an LVAD to help lower their TPG and make them suitable for heart only transplant. Following a reduction in their TPG patients were able to be listed for transplant.
1( 32) Analysis of Right Ventricular (RV) Regional and Global Systolic Function by Gated Blood Pool SPECT (GBPS) in Patients Undergoing Left Ventricular Assist Device (LVAD) Implantation C.B. Link , A. Nayak, P. Soman, M.A. Simon, J.J. Teuteberg, L. Lagazzi, A. Althouse, R. Kormos. HVI, UPMC, Pittsburgh, PA.
1( 31) Association Between the Use of Invasive Hemodynamic Monitoring and Outcomes with Percutaneous Left Ventricular Support: A Call for Standardization? J.J. Teuteberg ,1 W. O'Neill.2 1University of Pittsburgh, Pittsburgh, PA; 2Henry Ford, Detroit, MI. Purpose: The Impella microaxial catheters have been approved for use in high-risk PCI and cardiogenic shock. Despite this, their use in conjunction with right heart catheterization (RHC) has not been standardized. Methods: The Impella Quality (IQ) database is a repository of over 44,000 patients from over 1000 hospitals who have had clinical use of the Impella devices maintained by Abiomed. Patients were included starting 4/1/15 and if they had at least 4 patients enrolled. The cVAD Registry is a separate and ongoing, observational multicenter registry that includes patients implanted with the Impella. Both databases were queried for concomitant use of RHC with the Impella. Results: The IQ database has 3,159 patients with acute MI (AMI) or cardiogenic shock (CGS) of whom only 1500 (47.5%) had RHC. Overall survival to explant was 51%, but was 62% in those with RHC and 48% without RHC, p< 0.0001. When the survival was assessed by deciles, increased use of RHC was associated with increased survival, see Figure 1a. The cVAD Registry had 324 patients with AMI/CGS and demonstrated 30 day survival of 46% in those with RHC and 38% in those without RHC, log rank test p< 0.015, see Figure1b. Conclusion: In two large clinical databases of patients supported with an Impella in the setting of AMI/CGS an association between the use of invasive hemodynamic monitoring and improved survival has been demonstrated. While further analysis of the risk profiles of these patients is ongoing, the data suggests that invasive hemodynamic monitoring should be utilized in conjunction with percutaneous support in patients with AMI/CGS.
Purpose: Pre-LVAD assessment of RV function is critical for surgical planning, but is confounded by asymmetric RV geometry. GBPS is count based (no geometric assumptions), provides global and regional RV function, and needs minimal operator input. Methods: GBPS and hemodynamic data on 34 patients awaiting LVAD were prospectively collected. Analyzed GBPS variables included right ventricular ejection fraction (RVEF), RV end-diastolic volume (RVEDV), RV end-systolic volume (RVESV), and assessment of regional RV function. Regional RV wall motion was scored as: 0 - normal, or 1 - abnormal. Right ventricular failure (RVF) was defined as RVF requiring RV assist device or greater than 14 consecutive days of postoperative inotropes. Results: All 34 patients had RV global and regional function adequately assessed. Several patterns of regional dysfunction were observed including RV free wall hypokinesis (HK) in 20 patients (59%), RV basal wall HK in 12 patients (35%), apical HK in 10 patients (29%), and apical dyskinesis in 11 patients (32%) (see Figure). Of 34 patients, 5 (15%) developed postoperative RVF. The presence of a regional wall motion abnormality (free wall or basal wall HK) occurred more frequently in patients who developed RVF than patients who did not (100% vs. 59%, p= 0 .07). When divided by each region, abnormalities of the free wall were more common in patients with RVF (100% vs. 52%, p = 0.04), while basal and apical wall abnormalities were not. RVEF, RVEDV, and RVESV were not associated with RVF. No hemodynamic parameter on RHC was associated with RVF. Conclusion: Pre-operative assessment of regional and global RV function by GBPS is feasible in patients undergoing LVAD implantation and may provide useful prognostic data for surgical planning (LVAD vs. BiVAD). The ability to determine regional RV wall motion is an advantage over echocardiography.
The Journal of Heart and Lung Transplantation, Vol 36, No 4S, April 2017
was no statistical difference in early postoperative outcomes between the two groups including length of ICU stay, prolonged intubation, pneumonia, acute kidney injury, and stroke. In-hospital mortality was 3.8 % in the scIABP group, and 8.5 % in the LVAD group (P = 0.256). There was no statistical difference in the incidence of primary graft dysfunction (scIABP 4.9 % vs LVAD 10.6 %, P = 0.260), or rejection (> grade 3A) (scIABP 17.7 % vs LVAD 22.2 %, P= 0.565). Kaplan-Meier analysis showed 1-year survival did not differ between the groups (IABP 88.6 % vs LVAD 85.0 %, P = 0.342). Conclusion: BTT with scIABP support was associated with shorter operative time, shorter cardiopulmonary bypass time, and fewer blood transfusions, compared to LVAD support. scIABP is a favorable method for bridge to transplant in selected patients who respond to counter-pulsation therapy. 1( 28) Device Exchange Is Superior to Medical Therapy for Treating Continuous-Flow Left Ventricular Assist Device Thrombosis H. Kitahara , C. Juricek, D. Onsager, J. Reikhelkar, G. Kim, N. Sarswat, S. Adatya, G. Sayer, N. Uriel, T. Song, V. Jeevanandam, T. Ota. Cardiac Surgery, The University of Chicago, Chicago, IL. Purpose: Device thrombosis is a significant adverse event of left ventricular assist device (LVAD) therapy. This study aimed to compare the outcome of patients diagnosed with device thrombosis who treated with early device exchange to patients treated with medical therapy. Methods: All patients implanted with LVAD (HeartMate II) between July 2008 and December 2015 were included in this analysis. Device thrombosis was diagnosed by combination of positive ramp test, elevated lactate dehydrogenase, high free plasma hemoglobin , hematuria and device power spike. Indication for surgical intervention included persistent device thrombosis refractory to medical therapy, end-organ impairment, and hemodynamic instability. Results: Among a total of 277 LVAD patients, 37 (13.4%) were diagnosed with a device thrombosis and medical therapy with heparin was initiated. Surgical device exchange was subsequently performed in 23 patients (ST group), and medical therapy was continued in 14 patients (MT group). Device thrombosis was diagnosed by combination of positive ramp test (52.8 %), elevated lactate dehydrogenase (81.1 %), high free plasma hemoglobin (87.1 %), hematuria (40.5 %), and device power spike (67.6 %). The mean interval from LVAD implantation to device thrombosis was 381.0 ± 404.3 days. There was no statistical difference in patients’ characteristics between the groups. In-hospital mortality was 4.3 % (1/23) in the ST group and 28.6 % (4/14) in the MT group (P= 0.037). Kaplan-Meier analysis showed that 1-year survival was significantly better in the ST group compared to the MT group (ST 74.0 % vs MT 30.1 %; log-rank 0.001), and that freedom from cerebrovascular accident at 1 year was greater in the ST group (ST 87.1 % vs MT 47.7 %; log-rank 0.004). Conclusion: Device exchange was associated with improved 1-year survival and fewer cerebrovascular adverse events compared to medical therapy. Aggressive surgical intervention should be recommended for LVAD patients with device thrombosis.
1( 29) Mechanical Circulatory Support for Patients in Cardiogenic Shock After Right Ventricular Infarction: A Single-Center Experience K. Patel , K. Takeda, L. Truby, C. Eckhardt, K. Ross, D. Karmpaliotis, Y. Naka, V.K. Topkara, M. Yuzefpolskaya, P.C. Colombo, A. Kirtane, H. Takayama, A.R. Garan. Columbia University, New York, NY. Purpose: Right ventricular infarction (RVI) with cardiogenic shock (CS) carries a high mortality despite early revascularization. The use of mechanical circulatory support (MCS) in these patients has not been well described. Methods: We retrospectively reviewed 117 patients at our center placed on MCS (extracorporeal membrane oxygenation [ECMO], percutaneous [p] RV-assist device [RVAD], or surgical [s]RVAD) after acute MI from 20072016 to identify those with predominantly RVI. Baseline characteristics, type of device used, and outcomes were studied. Results: Fourteen patients (12%) suffered predominantly RVI and progressed to CS requiring MCS. The RCA was infarcted in 13/14 of cases and 13/14 were emergently revascularized (71.4% PCI, 28.6% CABG). Prior to MCS, the mean cardiac index was 1.79±0.67 L/min/m2, CVP was 15.0±1.85 mmHg, PCWP was 16.5±3.39 mmHg, and pulmonary artery pulsatility index was 1.03±0.43. TTE showed moderate-severe RV dysfunction in 92.9% and mean LVEF 41.7±14.3%. A pMCS device was used in 9 patients (6 ECMO, 3 pRVAD) and sRVAD in 5. Patients remained on MCS for a mean of 24 days (13±7days pRVAD vs. 44±23days sRVAD; p= 0.003); 12 (85.7%) patients survived to hospital discharge (88.9% pRVAD vs. 80.0% sRVAD). When compared to those with predominantly LV infarction (LVI) requiring MCS, patients with a RVI had similar age (61.7±12.3y RVI vs 59.3±11.3y LVI, p= 0.45) and degree of CS measured by cardiac power index (0.27±0.10 W/m2 RVI vs 0.23±0.21 W/m2 LVI, p= 0.64). However, RVI patients had a better 180days survival compared to LVI patients (84.4% RVI vs 48.6% LVI, p= 0.02, figure). Conclusion: In patients with RVI and CS, MCS use is associated with better than expected survival. Our findings indicate differences in the short-term recoverability of the right and left ventricle after AMI and severe CS requiring MCS.
1( 30) Durable LeftVentricular Assist Device Therapy to Reduce Transpulmonary Gradient in Adult Congenital Heart Disease to Facilitate Heart Transplant A. Woods , G. MacGowan, N. Robinson-Smith, L. Kenny, A. Hasan, S. Schueler. Cardiothoracic, Newcastle upon Tyne NHS Foundations Trust, Newcastle upon Tyne, United Kingdom. Purpose: Patients with Adult Congenital Heart Disease (ACHD) are often not eligible for heart only transplant due to high Trans Pulmonary Gradient (TPG). The introduction of durable Left Ventricular Assist Devices (LVAD) offers a new approach to make these highly complex patients transplantable. Methods: 15 patients with ACHD underwent LVAD implantation as either bridge to transplant or bridge to decision. All patients underwent right heart catheter prior to LVAD implant. Patients with a TPG ≥ 13 mmHg were
Abstracts S59 deemed unsuitable for heart only transplant. Pre and Post LVAD implant right heart catheters were reviewed. 11 Patients with a TPG of 13 or greater were deemed unsuitable for cardiac transplant (see Table 1). Exclusions from data: 2 died on LVAD before TPG could be rechecked: one awaiting post implant TPG leaving 8 patients with complete follow up. Results: Results are summarized in table 1. The diagnoses were as follows: Transposition of the Great Arteries (n= 6); coarctation of the aorta (n= 1); prior VSD closure (n= 1). Mean age of 33 and 13% women. TPG reduced after LVAD implant in 7 patients making them suitable for heart only transplant. 4 of these patients went on to have a transplant while 3 remain on LVAD support on the active waiting list. 1 patient with persistent high TPG went on to have a heart lung transplant. Patients spent an average time of 555 days (range 281-904) on LVAD support before their TPG was reduced to a level suitable for transplant Table 1.
TPG pre-LVAD (mmHg)
TPG post-LVAD (mmHg)
Time on LVAD before TPG suitable for listing (days)
13 21 18
6 8 19
643 747 0
15 17 16 20 13
4 10 12 11 6
249 454 904 610 281
Outcome Transplanted Transplanted Transplanted Heart and Lung Block Transplanted Transplanted on support on support on support
Conclusion: Patients with ACHD and high TPG can be successfully bridged with an LVAD to help lower their TPG and make them suitable for heart only transplant. Following a reduction in their TPG patients were able to be listed for transplant.
1( 32) Analysis of Right Ventricular (RV) Regional and Global Systolic Function by Gated Blood Pool SPECT (GBPS) in Patients Undergoing Left Ventricular Assist Device (LVAD) Implantation C.B. Link , A. Nayak, P. Soman, M.A. Simon, J.J. Teuteberg, L. Lagazzi, A. Althouse, R. Kormos. HVI, UPMC, Pittsburgh, PA.
1( 31) Association Between the Use of Invasive Hemodynamic Monitoring and Outcomes with Percutaneous Left Ventricular Support: A Call for Standardization? J.J. Teuteberg ,1 W. O'Neill.2 1University of Pittsburgh, Pittsburgh, PA; 2Henry Ford, Detroit, MI. Purpose: The Impella microaxial catheters have been approved for use in high-risk PCI and cardiogenic shock. Despite this, their use in conjunction with right heart catheterization (RHC) has not been standardized. Methods: The Impella Quality (IQ) database is a repository of over 44,000 patients from over 1000 hospitals who have had clinical use of the Impella devices maintained by Abiomed. Patients were included starting 4/1/15 and if they had at least 4 patients enrolled. The cVAD Registry is a separate and ongoing, observational multicenter registry that includes patients implanted with the Impella. Both databases were queried for concomitant use of RHC with the Impella. Results: The IQ database has 3,159 patients with acute MI (AMI) or cardiogenic shock (CGS) of whom only 1500 (47.5%) had RHC. Overall survival to explant was 51%, but was 62% in those with RHC and 48% without RHC, p< 0.0001. When the survival was assessed by deciles, increased use of RHC was associated with increased survival, see Figure 1a. The cVAD Registry had 324 patients with AMI/CGS and demonstrated 30 day survival of 46% in those with RHC and 38% in those without RHC, log rank test p< 0.015, see Figure1b. Conclusion: In two large clinical databases of patients supported with an Impella in the setting of AMI/CGS an association between the use of invasive hemodynamic monitoring and improved survival has been demonstrated. While further analysis of the risk profiles of these patients is ongoing, the data suggests that invasive hemodynamic monitoring should be utilized in conjunction with percutaneous support in patients with AMI/CGS.
Purpose: Pre-LVAD assessment of RV function is critical for surgical planning, but is confounded by asymmetric RV geometry. GBPS is count based (no geometric assumptions), provides global and regional RV function, and needs minimal operator input. Methods: GBPS and hemodynamic data on 34 patients awaiting LVAD were prospectively collected. Analyzed GBPS variables included right ventricular ejection fraction (RVEF), RV end-diastolic volume (RVEDV), RV end-systolic volume (RVESV), and assessment of regional RV function. Regional RV wall motion was scored as: 0 - normal, or 1 - abnormal. Right ventricular failure (RVF) was defined as RVF requiring RV assist device or greater than 14 consecutive days of postoperative inotropes. Results: All 34 patients had RV global and regional function adequately assessed. Several patterns of regional dysfunction were observed including RV free wall hypokinesis (HK) in 20 patients (59%), RV basal wall HK in 12 patients (35%), apical HK in 10 patients (29%), and apical dyskinesis in 11 patients (32%) (see Figure). Of 34 patients, 5 (15%) developed postoperative RVF. The presence of a regional wall motion abnormality (free wall or basal wall HK) occurred more frequently in patients who developed RVF than patients who did not (100% vs. 59%, p= 0 .07). When divided by each region, abnormalities of the free wall were more common in patients with RVF (100% vs. 52%, p = 0.04), while basal and apical wall abnormalities were not. RVEF, RVEDV, and RVESV were not associated with RVF. No hemodynamic parameter on RHC was associated with RVF. Conclusion: Pre-operative assessment of regional and global RV function by GBPS is feasible in patients undergoing LVAD implantation and may provide useful prognostic data for surgical planning (LVAD vs. BiVAD). The ability to determine regional RV wall motion is an advantage over echocardiography.