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195 Safely Transitioning from Inhaled Iloprost to Inhaled Treprostinil Sodium – Results from a Multicenter Open-Label Study in Patients with Pulmonary Arterial Hypertension
Abstracts 192 Psychosocial Evaluation before Left Ventricular Assist Device Implantation Can Predict Device Complication during Support N. Uriel,1 N. Gukasyan,1 S.W. Pak,2 G. George,2 E. Westfal,1 M. Flannery,2 J. Gonzales-Costello,1 D.B. Sims,1 P.C. Colombo,1 D. Mancini,1 H. Takayama,2 Y. Naka,2 U.P. Jorde,1 P.A. Shapiro.3 1 Medicine, Columbia University, New York, NY; 2Surgery, Columbia University, New York, NY; 3Psychiatry, Columbia University, New York, NY. Purpose: Life on a Left ventricular assist device (LVAD) requires a high level of compliance and understanding from pts and their families. The aim of this study was to evaluate whether psychosocial assessment prior to device implantation can predict device complications. Methods and Materials: A retrospective chart review of all pts implanted with LVAD as a bridge to transplant (BTT) between 1/2005 to 1/2010 was completed. Global psychiatric evaluation including psychiatric history, substance abuse compliance and motivation were collected from pretransplant evaluation. Social assessment i.e. social support, commuting distance and family status were collected from social work reports. Results: 145 pts were implanted with LVAD as BTT, and 113 pts had psychiatric and social evaluations and were included in this analysis. Mean age was 53.3⫾12.6 and 91(80.5%) were males. 40% had ischemic cardiomyopathy, 44.4% hypertensive and 35.7% had diabetes. 82 pts (72.5%) were transplanted within the study period. There were too few death to examine psychosocial evaluation as a predictor of survival. However, driveline infections were more common in pts with previous history of non-compliance (poor 37.5%, fair 9.1%, good 5.1% p⫽0.023), lacking social support (poor 28.6%, fair 13.9%, good 4.6% p⫽0.046), low function level (poor 33.3%, fair 17.2%, good 5.1% p⫽0.037) and in pts with history of a personality disorder (33.3% vs 5.6% p⫽0.004). Previous history of non-compliance was also related to higher frequency of thromboembolic events (poor 25.0%, fair 4.3%, good 2.53% p⫽0.039) and bleeding (poor 66.7%, fair 0%, good 33.3% p⫽0.001). Past substance abuse was not associated with adverse outcomes or device complications. Conclusions: Psychosocial evaluation can predict device complication. A more proactive support system should be considered when LVAD recipients have a history of non-compliance, personality disorder, poor social support or low functional status. 193 The Incremental Cost of Complications after Left Ventricular Assist Device Placement A. Iribarne,1 R. Easterwood,1 S.-W. Pak,1 M.J. Russo,2 K.N. Hong,1 J. Yang,1 H. Takayama,1 D.M. Mancini,1 Y. Naka.1 1Department of Surgery, Columbia University Medical Center, New York, NY; 2Section of Cardiac and Thoracic Surgery, The University of Chicago, Chicago, IL. Purpose: To quantify the net increase in hospital costs associated with major post-operative complications after left ventricular assist device (LVAD) placement. Methods and Materials: Data on all LVAD recipients from 1/1/03-1/1/10 at our institution (n⫽238) were retrospectively reviewed (HM XVE⫽114, HM II⫽85, other⫽39). Adjusted median post-operative hospital costs were analyzed by major complication category using bootstrapped quantile regression. Clinical outcomes included: complication frequency, in-hospital mortality, and length of stay (LOS). Results: The three most common complications included: renal failure requiring dialysis, pneumonia, and unplanned return to the operating room.[Figure 1]These three complications resulted in an average median increase in hospital costs of $123,966 ⫾ 21,755 (p⬍0.001). However, infections were among the most costly complications. Sternal wound infection, LVAD pocket infection, and sepsis resulted in an average median increase in hospital costs of $250,227 ⫾ 35,446 (p⬍0.001) and an average median increase in LOS of 43.1 ⫾ 7.9 days (p⬍0.001). Notably, overall rates of major infection were lower among HM II patients (p⫽0.021), with a resultant 9.6 ⫾ 3.5 day shorter median LOS (p⫽0.006) and $58,334 ⫾ 21,726 lower median cost of hospitalization compared to HM XVE (p⫽0.008). For the series, complications associated with in-hospital mortality
S71 included: sepsis (OR⫽4.7, p⫽0.001), cerebrovascular accident (OR⫽4.6, p⫽0.007), and renal failure requiring dialysis (OR⫽8.6, p⬍0.001).
Conclusions: Post-operative complications associated with LVAD placement have a significant impact on mortality and hospital costs. Achieving lower rates of complications, in part through device innovation, will increase the cost-effectiveness of LVADs. 194 Caregiver Burden in LVAD-DT: A Pilot Study K.M. Ferguson, S.C. Hull, J.F. Marble, E.K. Barg, J.N. Kirkpatrick. University of Pennsylvania, Philadelphia, PA. Purpose: LVADs are increasingly used as destination therapy (LVADDT) for patients who are not candidates for heart transplantation. The critical role of caregivers in supporting LVAD-DT recipients is receiving greater recognition, but the social and psychological ramifications of such a role remain poorly understood. Currently, no standard criteria exist for caregiver selection, preparation, or post-implantation support. Methods and Materials: Using a mixed methods research design, semistructured interviews were conducted with spouse and non-spouse caregivers of LVAD-DT recipients at a single academic medical center. Interviews were audiotaped and transcribed verbatim. Emergent themes were identified using a grounded theory approach and entered into NVivo software (Qualitative Solutions for Research, 1999) as codes. These codes were then used to group narrative responses as transcripts were entered into the software. The resultant codes and respective responses were then plotted for frequency and evaluated for subthemes. Results: 10 caregivers (90% female, mean age 59 years, range 38-77) participated. Several key themes emerged. 6/10 caregivers reported feeling emotionally and physically overwhelmed by their caregiving role and 7/10 reported feeling uninformed about the VAD. In describing their role, 7/10 caregivers said they were ill-prepared for the challenges they faced but 6/10 described feeling that they had no options in taking on this role. 6/10 caregivers were employed, and all reported an adverse impact on their work. Finally, only 1 caregiver reported giving any serious consideration to the issue of LVAD deactivation in an end of life situation. Conclusions: The assessment of caregiver burden should focus on the extent of involvement, mental preparation, and lifestyle adjustment of the caregiver. Furthermore, the role of a patient’s caregiver as his or her surrogate decision-maker merits further exploration, as caregivers may not be prepared to make end-of-life decisions regarding LVAD deactivation. 195 Safely Transitioning from Inhaled Iloprost to Inhaled Treprostinil Sodium – Results from a Multicenter Open-Label Study in Patients with Pulmonary Arterial Hypertension R.C. Bourge,1 V.F. Tapson,2 Z. Safdar,3 R.L. Benza,4 R.N. Channick,5 E.B. Rosenzweig,6 S. Shapiro,7 C.S. McSwain,8 A. Gotzkowsky,8 A. Nelsen,8 L.J. Rubin.9 1Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, AL; 2Pulmonary and Critical Care, Duke University Medical Center, Durham, NC; 3Pulmonary Critical Care Medicine, Baylor College of Medicine, Houston, TX; 4 Cardiovascular Diseases, Allegheny General Hospital, Pittsburgh, PA; 5 Pulmonary Hypertension Program, Massachusetts General Hospital, Boston, MA; 6Pediatric Cardiology, Columbia University, College of Physicians and Surgeons, New York, NY; 7Pulmonary and Critical Care, David Geffen School of Medicine at UCLA, Los Angeles, CA; 8United Therapeutics Corporation, Research Triangle Park, NC; 9Medicine, University of California San Diego, LaJolla, CA.
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The Journal of Heart and Lung Transplantation, Vol 30, No 4S, April 2011
Purpose: The delivery of inhaled iloprost (ILO) requires inhalation 6 to 9 times per day. Another inhaled therapy, treprostinil sodium (iTRE) may offer a safe and more convenient administration option (four times daily [qid]), while maintaining the clinical benefit of prostacyclins. Methods and Materials: Patients initiated iTRE at 3 breaths (6 ucg/ breath) qid after immediate termination of ILO in an open-label, prospective, multicenter study to assess the safety of transition, dosing, exercise capacity and quality of life (QoL). Dosing of iTRE was escalated as tolerated to a target dose of 9 breaths qid. The six-minute walk (6MW) test was used to measure exercise capacity, Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) to measure overall QoL, symptoms and functioning, and an activities diary to measure daily inhalation time. Measures were compared at baseline while on ILO and at 12 weeks on iTRE (Wilcoxon signed-rank test). Results: Twelve week results are described on the total cohort of 73 patients (57F: 16M, mean age 49 years). Forty-eight percent had idiopathic or familial pulmonary arterial hypertension (PAH); 42% were WHO Functional Class III; and median 6MW at Baseline was 378m. At entry, 59% were taking 5mcg ILO at least 6 times daily (ILO labeled dose is 2.5 – 5.0 mcg 6-9 times per day) Seventy-four percent of subjects were dosing at least 9 breaths qid of iTRE and reached 9 breaths in a mean of 18 days (SD:⫾17). 6MW improved by a median of 16 meters (p⬍0.001; mean⫾SD: 16⫾36). All domains of the CAMPHOR improved and were statistically significant at week 12 (p⬍0.001). Total daily inhalation time decreased from 66 min to 13 min while on iTRE (p⬍0.001). Common adverse events included cough (74%), headache (44%), and nausea (30%). No subject acutely deteriorated after transitioning. Conclusions: This study demonstrated that the rapid transition from inhaled ILO to iTRE in PAH patients is well tolerated and associated with maintenance of exercise capacity and improved QoL. 196 Sildenafil to Tadalafil Transition in Patients with Pulmonary Arterial Hypertension: A Retrospective Review O.A. Shlobin, A.W. Brown, N. Weir, L. Merte, S. Ahmad, K. Brown, S.D. Nathan. Advanced Lung Disease and Transplant Program, Inova Fairfax Hospital, Falls Church, VA. Purpose: Two phosphodiesterase-5 inhibitors are available for treatment of pulmonary arterial hypertension (PAH) with no direct comparison efficacy studies available. We sought to evaluate the success of transitioning patients from sildenafil to tadalafil. Methods and Materials: A retrospective study of stable PAH patients transitioned from sildenafil to tadalafil for dosing convenience. The primary endpoints were continuation on tadalafil without clinical deterioration and change in the 6 minute walk test distance (6MWD). Results: 35 patients qualified for the analysis (7 on dual and 10 on triple combination therapy). The mean pre-transition 6MWD of sildenafil patients was 363 meters (m). The transition to tadalafil was successful in 85.7% (30/35) of patients. The remaining 14.3% (5/30) (“failure group”) were switched back to sildenafil due to worsening symptoms. The average 6MWD change in the successful group was ⫹15.5m (-64 to ⫹140m) versus - 45 m (-123 to ⫹32m) in the “failure group” at approximately three months post-switch (p⫽0.02). Patients in the latter group took tadalafil for an average of 4.3 months (1.2-11.7 months). All 30 patients in the successful group remained on tadalafil with an average improvement in 6MWD of ⫹30.85m (-55 to 236m) at 12 months post-switch. The”failure” group had a higher daily sildenafil dose than the successfully transitioned group (180mg vs. 115.5mg; p⫽0.06). 42.8% of patients at the highest sildenafil dose (80mg TID) failed the transition. Conclusions: Transitioning from sildenafil to tadalafil is generally well tolerated in PAH patients. In the ⬃15% of patients who didn’t tolerate the change, pre-transition sildenafil dose was significantly higher. Such patients should be monitored closely if they are transitioned as the fixed dose regimen of tadalfil may not provide the equivalent therapeutic benefit. Successful transition was accompanied by a wide variability in 6MWD change.
197 Longitudinal Hemodynamic Changes in Pediatric Patients with Severe Pulmonary Arterial Hypertension (PAH) on Prostanoid Therapy S.L. Siehr,1 D. Ivy,2 K. Miller-Reed,2 M. Ogawa,1 D. Rosenthal,1 J.A. Feinstein.1 1Pediatric Cardiology, Stanford University, Lucile Packard Children’s Hospital, Palo Alto, CA; 2Pediatric Cardiology, University of Colorado Denver, The Children’s Hospital, Aurora, CO. Purpose: Currently, patients with severe PAH may be treated with epoprostenol (EPO) or treprostinil (TRE). Little is known about the longitudinal hemodynamic changes and outcomes of children on EPO or TRE. Methods and Materials: 2 center, retrospective study of 77 pediatric patients (46 females) on EPO or TRE from 1992 to 2010 was performed, examining hemodynamic parameters:right atrial pressure (RAP), cardiac index (CI), pulmonary vascular resistance (PVR) and PVR to systemic vascular resistance ratio (Rp:Rs). Outcomes grouped as (⫹) (on or off prostanoid) or (-) (death or transplantation). There were 47 with IPAH, 24 with CHD-APAH, and 6 others (GROUP 1 IPAH). Mean baseline age was 7.7⫾5.2 yr. Average follow up was 4.3⫾3.4 yr (range 0.04-13.3). 37 patients were treated with EPO alone, 20 with TRE alone, and 20 transitioned from EPO to TRE. Results: Baseline Rp:Rs was 0.9⫾0.4 and at last cath was 0.8⫾0.4 (p⫽NS). No differences were seen with subgroup analysis (EPO or TRE). Rp:Rs 1 year after transition from EPO to TRE increased from 0.6 to 0.8 (p⫽NS, n⫽7). 8 patients died or were transplanted within 2 years of baseline cath; of these, mean baseline Rp:Rs was 1.3⫾0.5 (p⬍0.01), mean RAP was 11.9⫾6.3 (v 7.0⫾3.5, p⬍0.01) and mean PVR was 28.3⫾13.9 (v 17.9⫾12.3, p⫽0.04). 39 patients remain on a prostanoid, 17 are off, 16 died on therapy and 5 received heart-lung transplant. Overall transplantfree survival is 70% at 5 years. Conclusions: There was an initial, though unsustained, trend towards improvement in Rp:Rs. Elevated Rp:Rs, RAP and PVR (but not CI) were significantly associated with early death or transplant. The overall survival curve when including TRE and transition patients is similar to previous reports for EPO.
198 COMPASS-3: Quality of Life in Patients with Pulmonary Arterial Hypertension 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, open-label, multi-center Phase 4 study investigating a bosentan-based, stepped approach to therapy. We investigated health-related quality of life (QOL) changes from baseline. Methods and Materials: 100 therapy-naïve patients with pulmonary arterial hypertension (PAH) with a baseline 6-minute walk distance (6MWD) between 150 and 360m received bosentan for 16 weeks. Patients not reaching 380m at Week 16 had sildenafil added (20 mg tid) while the others continued on monotherapy until Week 28. To assess QOL, patients completed the 36-item Short-Form Health Survey (SF-36) at baseline, Week 4, Week 16, and Week 28.
S71 included: sepsis (OR⫽4.7, p⫽0.001), cerebrovascular accident (OR⫽4.6, p⫽0.007), and renal failure requiring dialysis (OR⫽8.6, p⬍0.001).
Conclusions: Post-operative complications associated with LVAD placement have a significant impact on mortality and hospital costs. Achieving lower rates of complications, in part through device innovation, will increase the cost-effectiveness of LVADs. 194 Caregiver Burden in LVAD-DT: A Pilot Study K.M. Ferguson, S.C. Hull, J.F. Marble, E.K. Barg, J.N. Kirkpatrick. University of Pennsylvania, Philadelphia, PA. Purpose: LVADs are increasingly used as destination therapy (LVADDT) for patients who are not candidates for heart transplantation. The critical role of caregivers in supporting LVAD-DT recipients is receiving greater recognition, but the social and psychological ramifications of such a role remain poorly understood. Currently, no standard criteria exist for caregiver selection, preparation, or post-implantation support. Methods and Materials: Using a mixed methods research design, semistructured interviews were conducted with spouse and non-spouse caregivers of LVAD-DT recipients at a single academic medical center. Interviews were audiotaped and transcribed verbatim. Emergent themes were identified using a grounded theory approach and entered into NVivo software (Qualitative Solutions for Research, 1999) as codes. These codes were then used to group narrative responses as transcripts were entered into the software. The resultant codes and respective responses were then plotted for frequency and evaluated for subthemes. Results: 10 caregivers (90% female, mean age 59 years, range 38-77) participated. Several key themes emerged. 6/10 caregivers reported feeling emotionally and physically overwhelmed by their caregiving role and 7/10 reported feeling uninformed about the VAD. In describing their role, 7/10 caregivers said they were ill-prepared for the challenges they faced but 6/10 described feeling that they had no options in taking on this role. 6/10 caregivers were employed, and all reported an adverse impact on their work. Finally, only 1 caregiver reported giving any serious consideration to the issue of LVAD deactivation in an end of life situation. Conclusions: The assessment of caregiver burden should focus on the extent of involvement, mental preparation, and lifestyle adjustment of the caregiver. Furthermore, the role of a patient’s caregiver as his or her surrogate decision-maker merits further exploration, as caregivers may not be prepared to make end-of-life decisions regarding LVAD deactivation. 195 Safely Transitioning from Inhaled Iloprost to Inhaled Treprostinil Sodium – Results from a Multicenter Open-Label Study in Patients with Pulmonary Arterial Hypertension R.C. Bourge,1 V.F. Tapson,2 Z. Safdar,3 R.L. Benza,4 R.N. Channick,5 E.B. Rosenzweig,6 S. Shapiro,7 C.S. McSwain,8 A. Gotzkowsky,8 A. Nelsen,8 L.J. Rubin.9 1Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, AL; 2Pulmonary and Critical Care, Duke University Medical Center, Durham, NC; 3Pulmonary Critical Care Medicine, Baylor College of Medicine, Houston, TX; 4 Cardiovascular Diseases, Allegheny General Hospital, Pittsburgh, PA; 5 Pulmonary Hypertension Program, Massachusetts General Hospital, Boston, MA; 6Pediatric Cardiology, Columbia University, College of Physicians and Surgeons, New York, NY; 7Pulmonary and Critical Care, David Geffen School of Medicine at UCLA, Los Angeles, CA; 8United Therapeutics Corporation, Research Triangle Park, NC; 9Medicine, University of California San Diego, LaJolla, CA.
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The Journal of Heart and Lung Transplantation, Vol 30, No 4S, April 2011
Purpose: The delivery of inhaled iloprost (ILO) requires inhalation 6 to 9 times per day. Another inhaled therapy, treprostinil sodium (iTRE) may offer a safe and more convenient administration option (four times daily [qid]), while maintaining the clinical benefit of prostacyclins. Methods and Materials: Patients initiated iTRE at 3 breaths (6 ucg/ breath) qid after immediate termination of ILO in an open-label, prospective, multicenter study to assess the safety of transition, dosing, exercise capacity and quality of life (QoL). Dosing of iTRE was escalated as tolerated to a target dose of 9 breaths qid. The six-minute walk (6MW) test was used to measure exercise capacity, Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) to measure overall QoL, symptoms and functioning, and an activities diary to measure daily inhalation time. Measures were compared at baseline while on ILO and at 12 weeks on iTRE (Wilcoxon signed-rank test). Results: Twelve week results are described on the total cohort of 73 patients (57F: 16M, mean age 49 years). Forty-eight percent had idiopathic or familial pulmonary arterial hypertension (PAH); 42% were WHO Functional Class III; and median 6MW at Baseline was 378m. At entry, 59% were taking 5mcg ILO at least 6 times daily (ILO labeled dose is 2.5 – 5.0 mcg 6-9 times per day) Seventy-four percent of subjects were dosing at least 9 breaths qid of iTRE and reached 9 breaths in a mean of 18 days (SD:⫾17). 6MW improved by a median of 16 meters (p⬍0.001; mean⫾SD: 16⫾36). All domains of the CAMPHOR improved and were statistically significant at week 12 (p⬍0.001). Total daily inhalation time decreased from 66 min to 13 min while on iTRE (p⬍0.001). Common adverse events included cough (74%), headache (44%), and nausea (30%). No subject acutely deteriorated after transitioning. Conclusions: This study demonstrated that the rapid transition from inhaled ILO to iTRE in PAH patients is well tolerated and associated with maintenance of exercise capacity and improved QoL. 196 Sildenafil to Tadalafil Transition in Patients with Pulmonary Arterial Hypertension: A Retrospective Review O.A. Shlobin, A.W. Brown, N. Weir, L. Merte, S. Ahmad, K. Brown, S.D. Nathan. Advanced Lung Disease and Transplant Program, Inova Fairfax Hospital, Falls Church, VA. Purpose: Two phosphodiesterase-5 inhibitors are available for treatment of pulmonary arterial hypertension (PAH) with no direct comparison efficacy studies available. We sought to evaluate the success of transitioning patients from sildenafil to tadalafil. Methods and Materials: A retrospective study of stable PAH patients transitioned from sildenafil to tadalafil for dosing convenience. The primary endpoints were continuation on tadalafil without clinical deterioration and change in the 6 minute walk test distance (6MWD). Results: 35 patients qualified for the analysis (7 on dual and 10 on triple combination therapy). The mean pre-transition 6MWD of sildenafil patients was 363 meters (m). The transition to tadalafil was successful in 85.7% (30/35) of patients. The remaining 14.3% (5/30) (“failure group”) were switched back to sildenafil due to worsening symptoms. The average 6MWD change in the successful group was ⫹15.5m (-64 to ⫹140m) versus - 45 m (-123 to ⫹32m) in the “failure group” at approximately three months post-switch (p⫽0.02). Patients in the latter group took tadalafil for an average of 4.3 months (1.2-11.7 months). All 30 patients in the successful group remained on tadalafil with an average improvement in 6MWD of ⫹30.85m (-55 to 236m) at 12 months post-switch. The”failure” group had a higher daily sildenafil dose than the successfully transitioned group (180mg vs. 115.5mg; p⫽0.06). 42.8% of patients at the highest sildenafil dose (80mg TID) failed the transition. Conclusions: Transitioning from sildenafil to tadalafil is generally well tolerated in PAH patients. In the ⬃15% of patients who didn’t tolerate the change, pre-transition sildenafil dose was significantly higher. Such patients should be monitored closely if they are transitioned as the fixed dose regimen of tadalfil may not provide the equivalent therapeutic benefit. Successful transition was accompanied by a wide variability in 6MWD change.
197 Longitudinal Hemodynamic Changes in Pediatric Patients with Severe Pulmonary Arterial Hypertension (PAH) on Prostanoid Therapy S.L. Siehr,1 D. Ivy,2 K. Miller-Reed,2 M. Ogawa,1 D. Rosenthal,1 J.A. Feinstein.1 1Pediatric Cardiology, Stanford University, Lucile Packard Children’s Hospital, Palo Alto, CA; 2Pediatric Cardiology, University of Colorado Denver, The Children’s Hospital, Aurora, CO. Purpose: Currently, patients with severe PAH may be treated with epoprostenol (EPO) or treprostinil (TRE). Little is known about the longitudinal hemodynamic changes and outcomes of children on EPO or TRE. Methods and Materials: 2 center, retrospective study of 77 pediatric patients (46 females) on EPO or TRE from 1992 to 2010 was performed, examining hemodynamic parameters:right atrial pressure (RAP), cardiac index (CI), pulmonary vascular resistance (PVR) and PVR to systemic vascular resistance ratio (Rp:Rs). Outcomes grouped as (⫹) (on or off prostanoid) or (-) (death or transplantation). There were 47 with IPAH, 24 with CHD-APAH, and 6 others (GROUP 1 IPAH). Mean baseline age was 7.7⫾5.2 yr. Average follow up was 4.3⫾3.4 yr (range 0.04-13.3). 37 patients were treated with EPO alone, 20 with TRE alone, and 20 transitioned from EPO to TRE. Results: Baseline Rp:Rs was 0.9⫾0.4 and at last cath was 0.8⫾0.4 (p⫽NS). No differences were seen with subgroup analysis (EPO or TRE). Rp:Rs 1 year after transition from EPO to TRE increased from 0.6 to 0.8 (p⫽NS, n⫽7). 8 patients died or were transplanted within 2 years of baseline cath; of these, mean baseline Rp:Rs was 1.3⫾0.5 (p⬍0.01), mean RAP was 11.9⫾6.3 (v 7.0⫾3.5, p⬍0.01) and mean PVR was 28.3⫾13.9 (v 17.9⫾12.3, p⫽0.04). 39 patients remain on a prostanoid, 17 are off, 16 died on therapy and 5 received heart-lung transplant. Overall transplantfree survival is 70% at 5 years. Conclusions: There was an initial, though unsustained, trend towards improvement in Rp:Rs. Elevated Rp:Rs, RAP and PVR (but not CI) were significantly associated with early death or transplant. The overall survival curve when including TRE and transition patients is similar to previous reports for EPO.
198 COMPASS-3: Quality of Life in Patients with Pulmonary Arterial Hypertension 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, open-label, multi-center Phase 4 study investigating a bosentan-based, stepped approach to therapy. We investigated health-related quality of life (QOL) changes from baseline. Methods and Materials: 100 therapy-naïve patients with pulmonary arterial hypertension (PAH) with a baseline 6-minute walk distance (6MWD) between 150 and 360m received bosentan for 16 weeks. Patients not reaching 380m at Week 16 had sildenafil added (20 mg tid) while the others continued on monotherapy until Week 28. To assess QOL, patients completed the 36-item Short-Form Health Survey (SF-36) at baseline, Week 4, Week 16, and Week 28.