- Email: [email protected]
Reverse Remodeling with Combined Maximal Medical Therapy and Continuous Flow LVAD Support
S40 Journal of Cardiac Failure Vol. 17 No. 8S August 2011 in the figure; mean absolute difference between the Doppler and Terumo systolic BP was 5.760.8. Correlations between Doppler and Terumo systolic and between Doppler and Terumo MAP were 0.88 and 0.75, respectively (all p!0.0001). Conclusion: Terumo BP Monitor appears successful, reproducible and accurate when compared to Doppler. If further validated, this device may enable home BP monitoring, allowing cardiologists to optimize treatment over the phone and prevent unnecessary clinic visits.
125 Reverse Remodeling with Combined Maximal Medical Therapy and Continuous Flow LVAD Support Snehal R. Patel, Vivek Bhatia, Pauline Edwards, Cecelia Nucci, David Dallesandro, Daniel Goldstein, Simon Maybaum; Center for Advanced Cardiac Therapy, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY Background: Varying rates of cardiac recovery during LVAD support have been reported. The benefit of a protocol driven strategy of aggressive heart failure medication (HFMED) combined with continuous flow (CF) LVAD support are unknown. We report our single center experience with this approach. Methods: Acute ischemic (CAD) and non-ischemic (DCM) recipients of CF LVADs were seen bi-weekly for up-titration of HFMED to a target MAP of 70mmHg. One month after achieving maximal tolerated HFMED, cardiac function was assessed by echocardiogram with LVAD weaned. LVAD flow was reduced to an assumed net-zero flow of 6200rpm for 15 minutes. Patients with evidence for recovery underwent our previously described “3-Step” testing to determine eligibility for device explantation. Results: Between June 2006 and September 2010, 66 patients underwent implantation of a CF LVAD. Sixteen patients met criteria and underwent rapid HFMED uptitration. All subjects tolerated the LVAD weaning study without symptoms or drop in blood pressure. Five (31%) subjects demonstrated normalization of biventricular size and function (Table 1) and three underwent successful device explantation after 3-Step testing. In this small cohort, age, etiology of HF, and pre-LVAD LVEF were not predictive of cardiac improvement, while duration of HF was shorter in those who recovered. Interestingly, in all patients, ejection fraction did not significantly change when LVAD flow was weaned. Table 1. Baseline Characteristics
Age (years) Etiology Duration of HF prior to LVAD (days) Pre-LVAD LVEF (%) LVEDD (cm) LVAD Weaning Echo Time to Testing (days) PP - Full Support (mmHg) PP Wean (mmHg) LVEF (%) Full Support LVEF (%) Wean LVEDD (cm) - Wean RV FAC (%) - Wean 6 Minute Walk (m) - Wean
Improved (n55)
Non-Improved (n511)
59 (26-72) 3 DCM, 2 CAD 44 (10-180)
48 (22-61) 6 DCM, 5 CAD 840 (10-2900)
20 (15-23) 6.5 (5.7-7.0)
20 (10-25) 6.3 (4.5-10.6)
276 90 100 49 60 4.4 36 335
225 82 88 24 28 6.5 22 333
(157-458) (62-102) (70-125) (40-60) (51-62) (4.0-4.9) (31-50) (162-427)
(98-511) (60-104) (68-118) (15-37) (5-39) (5.6-10.1) (9-38) (168-468)
PP, peak pulsatile pressure. Conclusion: Combined HFMED and CF LVAD support leads to significant cardiac improvement in one third of patients. This strategy warrants further investigation.
126 Pilot Evaluation of a Novel Intra-Atrial Valved-Shunt (V-Wave Device) for Pressure-Dependent Cardiac Unloading in a Chronic Model of Ischemic Heart Failure Patrick I. McConnell1, Carlos L. del Rio2, Yaacov Nitzan3, Yukie Ueyama2, Pedro Vargas2, Adriana Pedraza2, Meni Jacoby3, Robert L. Hamlin2,4, Gad Keren3, William T. Abraham4, Stefan Verheye3; 1Nationwide Children’s Hospital, Columbus, OH; 2QTest Labs, Columbus, OH; 3V-Wave, Hod Hasahron, Israel; 4 The Ohio State University, Columbus, OH Introduction: Increased left-ventricular (LV) diastolic pressures, occurring during heart failure (HF), can increase myocardial energy demand and facilitate maladaptive remodeling. We hypothesized that LV unloading during periods of volume overload can mitigate remodeling/functional deterioration in HF. Therefore, we studied a novel intra-atrial one-way (left-to-right) valve (V-Wave) designed to act as a selective/pressure dependent shunt, implanted in animals with chronic ischemic heart (HF). Methods: Sheep (43.3 6 2.0 Kg) underwent serial/selective coronary embolizations resulting in chronic left HF (EF: 61 6 1 to 33 6 2%, LVIDd: 3.7 6 0.2 to 4.6 6 0.1 cm). Following HF induction, sheep were instrumented (via a right thoracotomy) with indwelling catheters into the pulmonary artery, the left atrium, and the right atrium/superior vena cava in order to monitor pressures and oxygen saturations.
The animals were assigned either to serve as controls (CTRL, n 5 5) or had the V-Wave device (n 5 6) deployed into the fossa ovalis. After recovery, valved-shunt patency (via Fick’s method), mean atrial/pulmonary pressures, and LV function (echocardiography) were evaluated weekly. Results: The valved-shunt acutely lowered left-atrial pressures (LAP, 15 6 1 to 11 6 1 mmHg, P ! 0.05) without increasing right-atrial/pulmonary-artery pressures (PAP: 18 6 1 to 17 6 1 mmHg). Implanted valved-shunts were patent for the duration of the study (12 weeks; mean Qp/Qs: 1.4 6 0.1 vs 0.7 6 0.1 in CTRL). Chronically, valve-treated sheep showed improved LV loading/function when compared to controls (progressive deterioration); e.g., at 4 weeks post-implant, valved sheep had lower filling pressures (LAP: 11 6 1 vs. 18 6 1 mmHg in CTRL, P!0.05) and preserved LV EF (40 6 3 vs. 22 6 1% in CTRL, P ! 0.05). The 6-week and 9-week survival in the V-Wave group were 80% vs. 40% and 20% (respectively) in controls. Conclusion: The V-Wave device, a novel intra-atrial valved-shunt designed to unload the left-heart in a pressure-dependent manner, lead to chronically reduced left-atrial pressure, preserved right-sided pressures, and improved LV function in a clinically-relevant chronic model of ischemic heart failure.
127 Left Ventricular Assist Devices Improve Functional Class but Fail To Normalize Peak Oxygen Consumption Casey R. Benton1, Gabriel Sayer2, Kimberly Ashley2, Rachel Flynn2, Ajith P. Nair2, Michael J. Domanski2, Anelechi C. Anyanwu3, Sean P. Pinney2; 1Medicine, The Mount Sinai Medical Center, New York, NY; 2Cardiology, The Mount Sinai Medical Center, New York, NY; 3Cardiothoracic Surgery, The Mount Sinai Medical Center, New York, NY Background: Heart failure patients implanted with a Left Ventricular Assist Device (LVAD) subjectively report marked symptomatic and functional improvement. One reason may be that LVAD support leads to a normalization of peak oxygen consumption (VO2), as measured by cardiopulmonary exercise testing (CPET). Methods: We performed a retrospective review of all patients implanted with a HeartMate II LVAD at our center as either bridge to transplantation or destination therapy from January 2009 through December 2010. Per protocol, all patients undergo transthoracic echocardiography, right heart catheterization, and CPET 3 months after implantation. Predicted peak VO2 was calculated using the Wasserman/Hansen equation. Results: 60 patients received a HeartMate II during the study period, with 18 (12 male, mean age 53 +/- 15 years) undergoing CPET an average of 6 months (182 +/- 98 days) after implantation. Of these, 7 also had CPET performed prior to LVAD implantation. NYHA functional class improved significantly after LVAD implantation (3.8 +/0.4 vs. 1.8 +/- 0.4, P!0.001). For all 18 patients, post-LVAD peak VO2 was significantly less than predicted peak VO2 (14.2 +/- 3.9 vs. 24.8 +/- 6.4 ml/kg/min, P! 0.001; percent-predicted 59.3 +/- 16.2%, P!0.001). For 7 patients with pre- and post-LVAD studies, peak VO2 increased significantly (15.8 +/- 4.0 vs. 11.3 +/- 5.9 ml/kg/min, P50.025), but remained markedly less than predicted peak VO2 (58.0 +/- 20.7% vs. 40.1 +/- 20.8%, P50.033). Intermacs level at implantation correlated with post-LVAD peak VO2 (r50.483, P50.043). Peak VO2 for Intermacs class 1 or 2 patients (n58) was significantly worse than for those with Intermacs class 3 or 4 (n510) (11.6 +/- 1.9 vs. 16.2 +/- 3.9 ml/kg/min, P50.006). Conclusions: Peak oxygen consumption improves significantly with LVAD support but fails to normalize to predicted age, sex, and BMI-matched values, despite a dramatic improvement in NYHA functional class. Patients with the most advanced Intermacs level fail to improve VO2 to the same extent as those with lesser degrees of heart failure.
128 Use of Luminex Antibody Testing and Virtual Crossmatching To Enhance Donor Heart Availability for Sensitized Heart Transplant Candidates: A Single Center Experience Robert L. Scott, Diane L. Kasper, Riccardo Valdez, Francisco A. Arabia, Carol S. Bachtel, Patrick A. DeValeria, D. Eric Steidley, Louis A. Lanza, Dawn E. Jaroszewski, Radha S. Gopalan, Anantharam V. Kalya, Scott T. Stoll, Octavio E. Pajaro, Stacie M. Attig; Heart Failure and Cardiac Transplantation, Mayo Clinic Arizona, Phoenix, AZ Hypothesis: We evaluated the safety and efficacy associated with the Luminex Multiplex Flow Cytometric Assay (Luminex) in conjunction with virtual crossmatching (VXM). Antibodies to human leukocyte antigens (HLA) in potential heart transplant (HT) recipients can limit access to transplantation. Anti-HLA antibodies can now be identified using the sensitive Luminex assay. Luminex also provides a measure of relative strength known as the mean fluorescence intensity (MFI). Using a combination of Luminex antibody data and corresponding MFI values, the likelihood of a negative or positive crossmatch can be virtually predicted. Methods and Materials: The Luminex assay was used to characterize anti-HLA antibodies in 14 sensitized HT recipient candidates (12 male). Current and historical HLA antibody data including MFI values were available in advance of the organ decision-making point for all sensitized candidates. An MFI value 3000 was chosen as a cut-off point for unacceptable donorspecific antibody (DSA). Results: All 14 patients were transplanted with a mean wait time of 7787 days. A VXM alone was employed for decision-making in 12/14 patients. A prospective crossmatch (XM) was performed in 2/14 patients, and both were negative. Retrospective XM were performed in all 12/14 patients, and 2/12 were positive. Two of 14 transplanted patients experienced an episode of ACR,
125 Reverse Remodeling with Combined Maximal Medical Therapy and Continuous Flow LVAD Support Snehal R. Patel, Vivek Bhatia, Pauline Edwards, Cecelia Nucci, David Dallesandro, Daniel Goldstein, Simon Maybaum; Center for Advanced Cardiac Therapy, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY Background: Varying rates of cardiac recovery during LVAD support have been reported. The benefit of a protocol driven strategy of aggressive heart failure medication (HFMED) combined with continuous flow (CF) LVAD support are unknown. We report our single center experience with this approach. Methods: Acute ischemic (CAD) and non-ischemic (DCM) recipients of CF LVADs were seen bi-weekly for up-titration of HFMED to a target MAP of 70mmHg. One month after achieving maximal tolerated HFMED, cardiac function was assessed by echocardiogram with LVAD weaned. LVAD flow was reduced to an assumed net-zero flow of 6200rpm for 15 minutes. Patients with evidence for recovery underwent our previously described “3-Step” testing to determine eligibility for device explantation. Results: Between June 2006 and September 2010, 66 patients underwent implantation of a CF LVAD. Sixteen patients met criteria and underwent rapid HFMED uptitration. All subjects tolerated the LVAD weaning study without symptoms or drop in blood pressure. Five (31%) subjects demonstrated normalization of biventricular size and function (Table 1) and three underwent successful device explantation after 3-Step testing. In this small cohort, age, etiology of HF, and pre-LVAD LVEF were not predictive of cardiac improvement, while duration of HF was shorter in those who recovered. Interestingly, in all patients, ejection fraction did not significantly change when LVAD flow was weaned. Table 1. Baseline Characteristics
Age (years) Etiology Duration of HF prior to LVAD (days) Pre-LVAD LVEF (%) LVEDD (cm) LVAD Weaning Echo Time to Testing (days) PP - Full Support (mmHg) PP Wean (mmHg) LVEF (%) Full Support LVEF (%) Wean LVEDD (cm) - Wean RV FAC (%) - Wean 6 Minute Walk (m) - Wean
Improved (n55)
Non-Improved (n511)
59 (26-72) 3 DCM, 2 CAD 44 (10-180)
48 (22-61) 6 DCM, 5 CAD 840 (10-2900)
20 (15-23) 6.5 (5.7-7.0)
20 (10-25) 6.3 (4.5-10.6)
276 90 100 49 60 4.4 36 335
225 82 88 24 28 6.5 22 333
(157-458) (62-102) (70-125) (40-60) (51-62) (4.0-4.9) (31-50) (162-427)
(98-511) (60-104) (68-118) (15-37) (5-39) (5.6-10.1) (9-38) (168-468)
PP, peak pulsatile pressure. Conclusion: Combined HFMED and CF LVAD support leads to significant cardiac improvement in one third of patients. This strategy warrants further investigation.
126 Pilot Evaluation of a Novel Intra-Atrial Valved-Shunt (V-Wave Device) for Pressure-Dependent Cardiac Unloading in a Chronic Model of Ischemic Heart Failure Patrick I. McConnell1, Carlos L. del Rio2, Yaacov Nitzan3, Yukie Ueyama2, Pedro Vargas2, Adriana Pedraza2, Meni Jacoby3, Robert L. Hamlin2,4, Gad Keren3, William T. Abraham4, Stefan Verheye3; 1Nationwide Children’s Hospital, Columbus, OH; 2QTest Labs, Columbus, OH; 3V-Wave, Hod Hasahron, Israel; 4 The Ohio State University, Columbus, OH Introduction: Increased left-ventricular (LV) diastolic pressures, occurring during heart failure (HF), can increase myocardial energy demand and facilitate maladaptive remodeling. We hypothesized that LV unloading during periods of volume overload can mitigate remodeling/functional deterioration in HF. Therefore, we studied a novel intra-atrial one-way (left-to-right) valve (V-Wave) designed to act as a selective/pressure dependent shunt, implanted in animals with chronic ischemic heart (HF). Methods: Sheep (43.3 6 2.0 Kg) underwent serial/selective coronary embolizations resulting in chronic left HF (EF: 61 6 1 to 33 6 2%, LVIDd: 3.7 6 0.2 to 4.6 6 0.1 cm). Following HF induction, sheep were instrumented (via a right thoracotomy) with indwelling catheters into the pulmonary artery, the left atrium, and the right atrium/superior vena cava in order to monitor pressures and oxygen saturations.
The animals were assigned either to serve as controls (CTRL, n 5 5) or had the V-Wave device (n 5 6) deployed into the fossa ovalis. After recovery, valved-shunt patency (via Fick’s method), mean atrial/pulmonary pressures, and LV function (echocardiography) were evaluated weekly. Results: The valved-shunt acutely lowered left-atrial pressures (LAP, 15 6 1 to 11 6 1 mmHg, P ! 0.05) without increasing right-atrial/pulmonary-artery pressures (PAP: 18 6 1 to 17 6 1 mmHg). Implanted valved-shunts were patent for the duration of the study (12 weeks; mean Qp/Qs: 1.4 6 0.1 vs 0.7 6 0.1 in CTRL). Chronically, valve-treated sheep showed improved LV loading/function when compared to controls (progressive deterioration); e.g., at 4 weeks post-implant, valved sheep had lower filling pressures (LAP: 11 6 1 vs. 18 6 1 mmHg in CTRL, P!0.05) and preserved LV EF (40 6 3 vs. 22 6 1% in CTRL, P ! 0.05). The 6-week and 9-week survival in the V-Wave group were 80% vs. 40% and 20% (respectively) in controls. Conclusion: The V-Wave device, a novel intra-atrial valved-shunt designed to unload the left-heart in a pressure-dependent manner, lead to chronically reduced left-atrial pressure, preserved right-sided pressures, and improved LV function in a clinically-relevant chronic model of ischemic heart failure.
127 Left Ventricular Assist Devices Improve Functional Class but Fail To Normalize Peak Oxygen Consumption Casey R. Benton1, Gabriel Sayer2, Kimberly Ashley2, Rachel Flynn2, Ajith P. Nair2, Michael J. Domanski2, Anelechi C. Anyanwu3, Sean P. Pinney2; 1Medicine, The Mount Sinai Medical Center, New York, NY; 2Cardiology, The Mount Sinai Medical Center, New York, NY; 3Cardiothoracic Surgery, The Mount Sinai Medical Center, New York, NY Background: Heart failure patients implanted with a Left Ventricular Assist Device (LVAD) subjectively report marked symptomatic and functional improvement. One reason may be that LVAD support leads to a normalization of peak oxygen consumption (VO2), as measured by cardiopulmonary exercise testing (CPET). Methods: We performed a retrospective review of all patients implanted with a HeartMate II LVAD at our center as either bridge to transplantation or destination therapy from January 2009 through December 2010. Per protocol, all patients undergo transthoracic echocardiography, right heart catheterization, and CPET 3 months after implantation. Predicted peak VO2 was calculated using the Wasserman/Hansen equation. Results: 60 patients received a HeartMate II during the study period, with 18 (12 male, mean age 53 +/- 15 years) undergoing CPET an average of 6 months (182 +/- 98 days) after implantation. Of these, 7 also had CPET performed prior to LVAD implantation. NYHA functional class improved significantly after LVAD implantation (3.8 +/0.4 vs. 1.8 +/- 0.4, P!0.001). For all 18 patients, post-LVAD peak VO2 was significantly less than predicted peak VO2 (14.2 +/- 3.9 vs. 24.8 +/- 6.4 ml/kg/min, P! 0.001; percent-predicted 59.3 +/- 16.2%, P!0.001). For 7 patients with pre- and post-LVAD studies, peak VO2 increased significantly (15.8 +/- 4.0 vs. 11.3 +/- 5.9 ml/kg/min, P50.025), but remained markedly less than predicted peak VO2 (58.0 +/- 20.7% vs. 40.1 +/- 20.8%, P50.033). Intermacs level at implantation correlated with post-LVAD peak VO2 (r50.483, P50.043). Peak VO2 for Intermacs class 1 or 2 patients (n58) was significantly worse than for those with Intermacs class 3 or 4 (n510) (11.6 +/- 1.9 vs. 16.2 +/- 3.9 ml/kg/min, P50.006). Conclusions: Peak oxygen consumption improves significantly with LVAD support but fails to normalize to predicted age, sex, and BMI-matched values, despite a dramatic improvement in NYHA functional class. Patients with the most advanced Intermacs level fail to improve VO2 to the same extent as those with lesser degrees of heart failure.
128 Use of Luminex Antibody Testing and Virtual Crossmatching To Enhance Donor Heart Availability for Sensitized Heart Transplant Candidates: A Single Center Experience Robert L. Scott, Diane L. Kasper, Riccardo Valdez, Francisco A. Arabia, Carol S. Bachtel, Patrick A. DeValeria, D. Eric Steidley, Louis A. Lanza, Dawn E. Jaroszewski, Radha S. Gopalan, Anantharam V. Kalya, Scott T. Stoll, Octavio E. Pajaro, Stacie M. Attig; Heart Failure and Cardiac Transplantation, Mayo Clinic Arizona, Phoenix, AZ Hypothesis: We evaluated the safety and efficacy associated with the Luminex Multiplex Flow Cytometric Assay (Luminex) in conjunction with virtual crossmatching (VXM). Antibodies to human leukocyte antigens (HLA) in potential heart transplant (HT) recipients can limit access to transplantation. Anti-HLA antibodies can now be identified using the sensitive Luminex assay. Luminex also provides a measure of relative strength known as the mean fluorescence intensity (MFI). Using a combination of Luminex antibody data and corresponding MFI values, the likelihood of a negative or positive crossmatch can be virtually predicted. Methods and Materials: The Luminex assay was used to characterize anti-HLA antibodies in 14 sensitized HT recipient candidates (12 male). Current and historical HLA antibody data including MFI values were available in advance of the organ decision-making point for all sensitized candidates. An MFI value 3000 was chosen as a cut-off point for unacceptable donorspecific antibody (DSA). Results: All 14 patients were transplanted with a mean wait time of 7787 days. A VXM alone was employed for decision-making in 12/14 patients. A prospective crossmatch (XM) was performed in 2/14 patients, and both were negative. Retrospective XM were performed in all 12/14 patients, and 2/12 were positive. Two of 14 transplanted patients experienced an episode of ACR,