- Email: [email protected]
60: Impact of Pre-Transplant Pulmonary Hypertension on Post-Transplant Outcomes in IPF
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The Journal of Heart and Lung Transplantation, Vol 29, No 2S, February 2010
Results: Baseline serum creatinine was 1.91 ⫾ 1.31 mg/dL and baseline GFR was 48.10 ⫾ 28 ml/min/1.73 m2 on admission while at the one month time point average creatinine was 2.13⫾ 1.50 mg/dL and average GFR was 44.37⫾ 26.65 ml/min/1.73 m2 (figure 1). Patients with ADHF due to RV failure showed a significant increase in serum creatinine (p⫽0.002) and significant decrease in GFR (p⫽0.027) when treated with nesiritide.[figure1]
Conclusions: While our study is limited by its retrospective nature and small sample size, caution should be exercised when using nesiritide in patients with RV failure and renal failure.
60 Impact of Pre-Transplant Pulmonary Hypertension on Post-Transplant Outcomes in IPF S.C. Mathai,1 R.E. Girgis,1 A. Shah,2 P.M. Hassoun,1 J.F. McDyer,1 J.B. Orens,1 C.A. Merlo.1 1Johns Hopkins University School of Medicine, Baltimore, MD; 2Johns Hopkins University School of Medicine, Baltimore, MD. Purpose: Patients with pulmonary hypertension (PH) who undergo lung transplantation (LTx) have a poorer survival than patients who undergo LTx for other conditions. Since pulmonary hypertension commonly complicates idiopathic pulmonary fibrosis (IPF), we sought to evaluate the impact of pre-LTx PH upon post-LTx survival in patients with IPF. Methods and Materials: Using the UNOS database, we identified 2065 patients with the diagnosis of IPF who underwent right heart catheterization (RHC) and LTx between 1998-2008. Using a definition of PH as mPAP ⬎ 25 mmHg, we compared patients with and without PH. Survival analyses were used to assess the predictive value of three measures of pulmonary vascular disease: mPAP⬎25mmHg, mPAP⬎25 with PCWP⬍15mmHg and PVR⬎3 Wood units(WU), and PVR⬎3 WU. Results: Complete RHC data was available on 1848 patients who underwent LTx; 609 (33%) had PH complicating IPF (PH-IPF). When compared to IPF patients without PH, PH-IPF patients tended to be younger (mean age 56⫾9 vs. 57⫾9 years, p⫽0.02), have less restrictive lung disease (mean FVC % predicted, 50⫾18 vs, 48⫾15%, p⬍0.01), and require more supplemental oxygen. There were no differences in gender, time on the waiting list, or renal function. CO was lower in the PH-IPF group (5.4⫾1.5 vs 5.6⫾1.5 L/min, p⫽0.05), while PCWP was higher (10⫾3 vs. 8⫾4 mmHg, p⬍0.01). PH was associated with a poorer outcome at 30-days, 90-days, and 1-year. PVR⬎3 Wood units was the strongest hemodynamic predictor of survival, conferring over 60% increased risk of death at 30-days (HR 1.62, p⬍0.01), over 30% at 90-days (HR 1.36, p⫽0.02), and over 25% at 1-year (HR 1.25, p⫽0.02). These relationships persisted when controlling for age, FVC, ischemic time, and renal function. Conclusions: Patients with PH-IPF have a significantly worse post-transplant survival than IPF patients without PH. Elevated PVR prior to LTx appears to be the best hemodynamic predictor of mortality at 30-days, 90-days, and 1-year. Further studies are needed to identify potential mechanisms and interventions that may improve outcomes in PH-IPF.
61 Correlation of Right Heart Catheterization (RHC) Parameters and Functional Tests after 16 Weeks of Bosentan-Based Therapy in Patients with Pulmonary Arterial Hypertension (PAH): The COMPASS3 Study F. Torres,1 S. Murali,2 F.J. Soto,3 H. Gupta,4 M.H. Park,5 N. Frey,6 R.L. Benza.2 1University of Texas Southwestern Medical Center, Dallas, TX; 2Allegheny General Hospital, PIttsburgh, PA; 3Prevea Health, Sheboygan, WI; 4University of Alabama at Birmingham, Birmingham, AL; 5University of Maryland School of Medicine, Baltimore, MD; 6 Actelion Pharmaceuticals US, Inc., South San Francisco, CA. Purpose: COMPASS-3 is a prospective, multi-center study which uses a targeted 6-minute walk test distance (6MWD) threshold approach to guide bosentan-based combinational therapy. Correlations of changes in RHC parameters to 6MWD at Week 16 are investigated. Methods and Materials: 100 therapy-naı¨ve PAH patients with baseline 6MWD 150-360m will receive bosentan for 16 weeks. Those not reaching a 6MWD ⱖ380m at Week 16 had sildenafil added (20 mg tid) while the others continued on bosentan monotherapy. Results: Mean age was 55.5 years; time since diagnosis, 0.7⫾2.2 years, 59% had idiopathic PAH and 82% were female. By Week 16, mean⫾SD change in 6MWD was 22.9⫾75.9m (P⫽0.0036) and in BDI was ⫺0.35⫾1.84 (P⫽0.071). By Week 16, there were significant changes in CI, mPAP, PVR, and stroke volume index. The correlations between changes in RHC parameters and functional tests by Week 16 are shown in the Table.[table1]
Correlations between changes in RHC parameters and functional tests (total cohort) Parameter
Change in 6MWD, r value (P value) n
mPAP mRAP SVO2 CI PVR Stroke Volume Index
⫺.21 (0.0451) 90 ⫺.10 (0.37) 89 ⫺.23 (0.051) 74 0.31 (0.0032) 88 ⫺.36 (0.0006) 86 0.25 (0.0237) 83
Conclusions: As shown in previous studies, hemodynamic parameters provide some correlation with the functional marker exercise tolerance. Out of the hemodynamic markers, PVR is the one revealing more clinically significant correlation and outcome prediction. 62 Strategies for LVAD Therapy in INTERMACS: Intent Rate v. Event Rate J.J. Teuteberg,2 G.C. Stewart,1 M. Jessup,3 R.L. Kormos,2 B. Sun,4 O.H. Frazier,5 D.C. Naftel,6 L.W. Stevenson.1 1Brigham and Women’s Hospital, Boston, MA; 2University of Pittsburgh Medical Center, Pittsburgh, PA; 3University of Pennsylvania, Philadelphia, PA; 4Ohio State University Medical Center, Columbus, OH; 5Texas Heart Institute, Houston, TX; 6University of Alabama at Birmingham, Birmingham, AL. Purpose: Left ventricular assist device (LVAD) implantation strategy impacts candidate selection and constrains clinical trial design. As concepts of device strategy evolve, we evaluated how initial intent for LVAD implant influences actual outcomes. Methods and Materials: For patients entered in INTERMACS with primary LVAD (pulsatile or continuous flow) from June 2006 through March 2009, initial strategies were bridge to transplant already listed (BTT); bridge to candidacy (BTC) with 3 levels of likelihood; intended destination therapy (DT); and bridge to recovery (BTR). Primary analyses compared BTT, BTC and DT outcomes by 12 months. Results: Primary LVAD recipients (n⫽1092) had mean age 52 yrs, 79% male, 51% continuous flow pumps, 30% were INTERMACS level 1 and 40% INTERMACS level 2. Strategy at implant was BTT 45%, BTC 42% (likely to be listed 28%, moderately likely 9%, unlikely 5%), DT 9% and
The Journal of Heart and Lung Transplantation, Vol 29, No 2S, February 2010
Results: Baseline serum creatinine was 1.91 ⫾ 1.31 mg/dL and baseline GFR was 48.10 ⫾ 28 ml/min/1.73 m2 on admission while at the one month time point average creatinine was 2.13⫾ 1.50 mg/dL and average GFR was 44.37⫾ 26.65 ml/min/1.73 m2 (figure 1). Patients with ADHF due to RV failure showed a significant increase in serum creatinine (p⫽0.002) and significant decrease in GFR (p⫽0.027) when treated with nesiritide.[figure1]
Conclusions: While our study is limited by its retrospective nature and small sample size, caution should be exercised when using nesiritide in patients with RV failure and renal failure.
60 Impact of Pre-Transplant Pulmonary Hypertension on Post-Transplant Outcomes in IPF S.C. Mathai,1 R.E. Girgis,1 A. Shah,2 P.M. Hassoun,1 J.F. McDyer,1 J.B. Orens,1 C.A. Merlo.1 1Johns Hopkins University School of Medicine, Baltimore, MD; 2Johns Hopkins University School of Medicine, Baltimore, MD. Purpose: Patients with pulmonary hypertension (PH) who undergo lung transplantation (LTx) have a poorer survival than patients who undergo LTx for other conditions. Since pulmonary hypertension commonly complicates idiopathic pulmonary fibrosis (IPF), we sought to evaluate the impact of pre-LTx PH upon post-LTx survival in patients with IPF. Methods and Materials: Using the UNOS database, we identified 2065 patients with the diagnosis of IPF who underwent right heart catheterization (RHC) and LTx between 1998-2008. Using a definition of PH as mPAP ⬎ 25 mmHg, we compared patients with and without PH. Survival analyses were used to assess the predictive value of three measures of pulmonary vascular disease: mPAP⬎25mmHg, mPAP⬎25 with PCWP⬍15mmHg and PVR⬎3 Wood units(WU), and PVR⬎3 WU. Results: Complete RHC data was available on 1848 patients who underwent LTx; 609 (33%) had PH complicating IPF (PH-IPF). When compared to IPF patients without PH, PH-IPF patients tended to be younger (mean age 56⫾9 vs. 57⫾9 years, p⫽0.02), have less restrictive lung disease (mean FVC % predicted, 50⫾18 vs, 48⫾15%, p⬍0.01), and require more supplemental oxygen. There were no differences in gender, time on the waiting list, or renal function. CO was lower in the PH-IPF group (5.4⫾1.5 vs 5.6⫾1.5 L/min, p⫽0.05), while PCWP was higher (10⫾3 vs. 8⫾4 mmHg, p⬍0.01). PH was associated with a poorer outcome at 30-days, 90-days, and 1-year. PVR⬎3 Wood units was the strongest hemodynamic predictor of survival, conferring over 60% increased risk of death at 30-days (HR 1.62, p⬍0.01), over 30% at 90-days (HR 1.36, p⫽0.02), and over 25% at 1-year (HR 1.25, p⫽0.02). These relationships persisted when controlling for age, FVC, ischemic time, and renal function. Conclusions: Patients with PH-IPF have a significantly worse post-transplant survival than IPF patients without PH. Elevated PVR prior to LTx appears to be the best hemodynamic predictor of mortality at 30-days, 90-days, and 1-year. Further studies are needed to identify potential mechanisms and interventions that may improve outcomes in PH-IPF.
61 Correlation of Right Heart Catheterization (RHC) Parameters and Functional Tests after 16 Weeks of Bosentan-Based Therapy in Patients with Pulmonary Arterial Hypertension (PAH): The COMPASS3 Study F. Torres,1 S. Murali,2 F.J. Soto,3 H. Gupta,4 M.H. Park,5 N. Frey,6 R.L. Benza.2 1University of Texas Southwestern Medical Center, Dallas, TX; 2Allegheny General Hospital, PIttsburgh, PA; 3Prevea Health, Sheboygan, WI; 4University of Alabama at Birmingham, Birmingham, AL; 5University of Maryland School of Medicine, Baltimore, MD; 6 Actelion Pharmaceuticals US, Inc., South San Francisco, CA. Purpose: COMPASS-3 is a prospective, multi-center study which uses a targeted 6-minute walk test distance (6MWD) threshold approach to guide bosentan-based combinational therapy. Correlations of changes in RHC parameters to 6MWD at Week 16 are investigated. Methods and Materials: 100 therapy-naı¨ve PAH patients with baseline 6MWD 150-360m will receive bosentan for 16 weeks. Those not reaching a 6MWD ⱖ380m at Week 16 had sildenafil added (20 mg tid) while the others continued on bosentan monotherapy. Results: Mean age was 55.5 years; time since diagnosis, 0.7⫾2.2 years, 59% had idiopathic PAH and 82% were female. By Week 16, mean⫾SD change in 6MWD was 22.9⫾75.9m (P⫽0.0036) and in BDI was ⫺0.35⫾1.84 (P⫽0.071). By Week 16, there were significant changes in CI, mPAP, PVR, and stroke volume index. The correlations between changes in RHC parameters and functional tests by Week 16 are shown in the Table.[table1]
Correlations between changes in RHC parameters and functional tests (total cohort) Parameter
Change in 6MWD, r value (P value) n
mPAP mRAP SVO2 CI PVR Stroke Volume Index
⫺.21 (0.0451) 90 ⫺.10 (0.37) 89 ⫺.23 (0.051) 74 0.31 (0.0032) 88 ⫺.36 (0.0006) 86 0.25 (0.0237) 83
Conclusions: As shown in previous studies, hemodynamic parameters provide some correlation with the functional marker exercise tolerance. Out of the hemodynamic markers, PVR is the one revealing more clinically significant correlation and outcome prediction. 62 Strategies for LVAD Therapy in INTERMACS: Intent Rate v. Event Rate J.J. Teuteberg,2 G.C. Stewart,1 M. Jessup,3 R.L. Kormos,2 B. Sun,4 O.H. Frazier,5 D.C. Naftel,6 L.W. Stevenson.1 1Brigham and Women’s Hospital, Boston, MA; 2University of Pittsburgh Medical Center, Pittsburgh, PA; 3University of Pennsylvania, Philadelphia, PA; 4Ohio State University Medical Center, Columbus, OH; 5Texas Heart Institute, Houston, TX; 6University of Alabama at Birmingham, Birmingham, AL. Purpose: Left ventricular assist device (LVAD) implantation strategy impacts candidate selection and constrains clinical trial design. As concepts of device strategy evolve, we evaluated how initial intent for LVAD implant influences actual outcomes. Methods and Materials: For patients entered in INTERMACS with primary LVAD (pulsatile or continuous flow) from June 2006 through March 2009, initial strategies were bridge to transplant already listed (BTT); bridge to candidacy (BTC) with 3 levels of likelihood; intended destination therapy (DT); and bridge to recovery (BTR). Primary analyses compared BTT, BTC and DT outcomes by 12 months. Results: Primary LVAD recipients (n⫽1092) had mean age 52 yrs, 79% male, 51% continuous flow pumps, 30% were INTERMACS level 1 and 40% INTERMACS level 2. Strategy at implant was BTT 45%, BTC 42% (likely to be listed 28%, moderately likely 9%, unlikely 5%), DT 9% and