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Post EVLP Cold Preservation Period Is Associated With Clinical Outcomes
S96
The Journal of Heart and Lung Transplantation, Vol 34, No 4S, April 2015
remains poorly defined to date. We sought to describe the survival of patients with cardiac amyloidosis awaiting heart transplant with CS. Methods: Patients (n= 155) evaluated for OHT with AL or TTR cardiac amyloidosis at ten institutions were included. Data obtained via chart review was entered into the secure SSL-encrypted online database, Research Electronic Data Capture (REDCap). Patients were stratified into three groups by placement of VAD, placement of intraaortic balloon pump (IABP), or no CS. Differences between demographic and clinical characteristics were evaluated and Kaplan Meier survival estimates based on time to transplant and mortality were performed. Results: 34 of 113 (30%) AL patients required CS, 8 with VAD, 3 with biventricular assist, and 23 with IABP. Only one out of 33 (3%) TTR patients required CS (LVAD). Half of all NYHA class 4 patients required circulatory support (8 with VAD, 15 with IABP). 8 VADs were placed in patients evaluated for transplant between the year 2000 and 2008 and 4 were placed after the year 2008. Patients with VADs had higher mean PAP, PCWP, and PVR with lower LVEF and higher right ventricular stroke work index compared to those with IABP or without CS (p= 0.028). Patients with VAD were most likely to die from pump failure or multisystem organ failure, while patients with IABP were most likely to die of cardiac arrest (p= 0.001). One-year survival rate was 76% in those without CS, 52% in those with IABP, and 33% in those with VAD. There was no difference in time to death or time to transplant when stratified by no CS, IABP, and VAD (p= 0.271, p= 0.312). Conclusion: Patients with cardiac amyloidosis requiring CS have decreased survival rates compared to previously published INTERMACS data for all HF etiologies. Further investigation is needed to address the ability of VAD to provide the appropriate support for patients with cardiac amyloidosis. The poor survival of cardiac amyloid patients awaiting transplant despite CS suggests that these patients should receive priority on the waitlist. 2( 42) The Organ Care System (OCS™) Lung INSPIRE International Trial Results G. Warnecke ,1 D. Van Raemdonck,2 M. Smith,3 J. Kukreja,4 G. Loor,5 F. Rea,6 G. Massard,7 F. De Robertis,8 J. Nagendran,9 J. Moradiellos,10 K. Dhital,11 C. Knosalla,12 C. Bermudez,13 S. Tsui,14 J. Garcia,15 I. Wang,16 K. McCurry,17 F. Wagner,18 G. Leseche,19 P. Thomas,20 B. Weigmann,1 I. Tudorache,1 C. Kühn,1 M. Avsar,1 W. Sommer,1 M. Schiavon,6 N. Santelmo,7 P. Falcoz,7 A. Olland,7 T. Deuse,18 A. Varela,10 A. Simon,8 J. Madsen,15 M. Hertz,5 H. Reichenspurner,18 A. Haverich,1 A. Ardehali.21 1Hannover Medical School, Hannover, Germany; 2Leuven University Hospital, Leuven, Belgium; 3St. Joseph’s Medical Center, Phoenix, AZ; 4University of California San Francisco Medical Center, San Francisco, CA; 5University of Minnesota Medical Center, Minneapolis, MN; 6University of Padua Hospital, Padua, Italy; 7Strasbourg University Hospital, Strasbourg, France; 8Harefield Hospital, London, United Kingdom; 9University of Alberta Medical Center, Edmonton, AB, Canada; 10University Puerta de Hierro Hospital, Madrid, Spain; 11St. Vincent’s Hospital, Sydney, Australia; 12German Heart Institute, Berlin, Germany; 13University of Pittsburgh Medical Center, Pittsburgh, PA; 14Papworth Hospital, Cambridge, United Kingdom; 15Massachusetts General Hospital, Boston, MA; 16Indiana University Medical Center, Indianapolis, IN; 17Cleveland Clinic Foundation, Cleveland, OH; 18Hamburg University Hospital, Hamburg, Germany; 19Bichat Hospital, Paris, France; 20University Hospitals of Marseille, Marseille, France; 21Ronald Reagan UCLA Medical Center, Los Angeles, CA. Purpose: The OCS Lung INSPIRE Trial is a large prospective international randomized trial to evaluate the impact of using portable ex-vivo machine perfusion with OCS Lung technology to standard of care - cold storage on clinical outcomes in routine lung transplantation. Methods: INSPIRE Trial compares preservation of donor lungs using OCSLung perfusion device (Treatment Group) to Cold flush and storage (Control Group). A total of 350 primary lung transplant recipients will be randomized into the trial. Donor Inclusion Criteria: age < 65, normal gas exchange at time of final acceptance of donor lung, and no active primary pulmonary disease. Recipient Inclusion Criteria: age ≥ 18 years old; registered male or female primary double lung transplant candidate; & signed written informed consent for the trial. Donor Exclusion Criteria: positive serology; presence of moderate to severe traumatic lung injury; & presence of confirmed active
pneumonia. Recipient Exclusion Criteria: prior solid organ or bone marrow transplant; single lung recipient; chronic use of renal dialysis or diagnosed of chronic renal dysfunction; and multi-organ transplant recipient. Results: Primary study endpoint is a composite of patient survival and incidence of ISHLT Primary Graft Dysfunction (PGD) Grade 3 during the first 72 hours post-transplantation. Secondary Endpoints: Incidence of ISHLT PGD Grade 3 at 72 hours post-transplantation; Incidence of ISHLT PGD Grade 2 or 3 at 72 hours post-transplantation; Patient and graft survival at day 30. Long-term endpoints: incidence of BOS at 2 years post transplant and Pulmonary Function Tests at 6, 12, and 24 months post transplant. Conclusion: To-date 340 patients were transplanted in 21 transplant centers worldwide. We will report the final results at the ISHLT 2015 late breaking clinical trial session. 2( 43) Post EVLP Cold Preservation Period Is Associated With Clinical Outcomes E. Arango Tomas ,1 P. Sanchez,2 R.D. Davis,3 E. Cantu,4 M.J. Weyant,5 D. Lederer,1 P.C. Camp,6 B.P. Griffith,2 F. D’Ovidio.1 1Columbia University Medical Center, New York, NY; 2University of Maryland Medical Center, Baltimore, MD; 3Duke University, Durham, NC; 4University of Pennsylvania, Philadelphia, PA; 5University of Colorado Denver, Denver, CO; 6Brigham and Women’s Hospital, Boston, MA. Purpose: Ex vivo lung perfusion (EVLP) is changing the lung preservation paradigm. Standard cold preservation is followed by normothermic EVLP, then lungs undergo a second cold preservation prior to implantation. We recently demonstrated that high-risk lungs re-assessed by EVLP have similar outcomes to standard criteria lungs. Nevertheless a paucity of data exist on how the sequence of cold-normothermic-cold preservations affect outcomes. We investigated the effects of preservation times in transplanted EVLP lungs. Methods: Data from the NOVEL trial was retrospectievly analyzed. Duration of the 3 preservation phases was measured: cold pre EVLP; EVLP; cold post EVLP. Donor & recipient clinical data were collected. Primary graft dysfunction (PGD) and 1 year mortality were monitored. Results: Complete data was obtained on 42 pts transplanted post EVLP. At 72hrs PGD 2 was present in 5/42 (12%) and PGD3 in 4/42 (9%). One-year mortality was 6/42 (16%). Using a 75th percentile cut-off time a cold post EVLP time ≥ 322min was considered Extended. ROC method confirmed cutoff for accuracy towards PGD or 1-yr mortality. Logistic regression analysis for Extended cold post-EVLP preservation and PGD (2 or 3) at 72hrs showed OR 11.2 (95%CI 2.1-60.2) p< 0.005, and when adjusted for normothermic EVLP time OR= 9 (95% CI 1.4-46.8) p= 0.02. Cox proportional analysis for 1 year survival showed HR 15 (95%CI 1.7-129) p= 0.01, and when adjusted for EVLP time HR 18 (95% 1.9-176) p= 0.01. Tables shows the Chi square analysis (Fisher’s test p< 0.05). No association was noted with the cold pre EVLP preservation. Conclusion: Cold preservation post EVLP seems to adversely impact on clinical outcomes. In particular, extended (> 5hrs) duration of cold post EVLP preservation times associated with a significantly greater risk for PGD and one-year mortality. These preliminary findings from a small cohort of patients in a multicenter trial need to be confirmed in a larger cohort, although should caution on the implementation of extended duration of cold preservation post EVLP.
Abstracts S97 2( 44)
2( 45)
Metabolic Assessment of Marginal Donor Lungs During Ex-Vivo Perfusion (EVLP): New Parameters for Decision Making A. Slama , M. Barta, L. Schillab, A. Mitterbauer, P. Jaksch, K. Hoetzenecker, W. Klepetko, C. Aigner. Medical Univ of Vienna, Vienna, Austria.
Lung Compliance During Ex Vivo Lung Perfusion Predicts Early Post Transplant Outcomes P.G. Sanchez ,1 G.J. Bittle,1 E. Cantu III,2 F. D Ovidio,3 M. Weyant,4 R.D. Davis,5 B.P. Griffith.1 1Cardiac Surgery, University of Maryland, Baltimore, MD; 2Cardiac Surgery, University of Pennsylvania, Philadelphia, PA; 3Thoracic Surgery, Columbia University, New York, NY; 4Thoracic Surgery, University of Colorado, Aurora, CO; 5Cardiac Surgery, Duke University, Durham, NC.
Purpose: EVLP has become a widespread method to evaluate marginal donor lungs. Nevertheless, strong evidence on accurate judgment of graft quality by individual functional parameters is still missing. Anaerobic glucose metabolism might be dependent on graft quality and serve as a parameter for decision making during EVLP. Methods: This is an analysis of our prospective EVLP database. Since 2010, 43 EVLP were performed with initially rejected marginal donor lungs. 28 (65%) of these lungs were accepted after EVLP and transplanted with results comparable to standard donor lungs. Absolute glucose consumption and lactate production were calculated and corrected for hourly changes of perfusate and additional glucose administration. These values were compared between accepted (group A) and rejected lungs (group B). Linear regression was performed and the slope values were indexed for donor pTLC to correct for graft size. Results: Mean EVLP Duration was 275±87 min. (group A, n= 28) vs. 297 min. (group B, n= 15: 238 min; p= 0.039). Subsequently accepted lungs showed a significantly lower total glucose consumption (T1h:-899 vs.-1258 mg; p= 0.29/ T2h:-1625 vs.-2293 mg; p= 0.058/ T3h: 2432 vs.-3380 mg; p= 0.015/ T4h:-2812 vs.-4771 mg; p< 0.001) and lower lactate production (T1h:7.5 vs.9.5mmol; p= 0.44/ T2h: 15 vs. 19.6 mmol; p= 0.09/ T3h: 22.3 vs. 29 mmol; p= 0.02/ T4h:27 vs. 42.7mmol; p< 0.001). In linear regression analysis glucose consumption and lactate production slopes were significantly different between the groups (glucose:-2.03 ±1.03 vs.-3.06 ±1.41 mg/min/ LTLCp;p= 0.021/ lactate: 0.019 ±0.008 vs. 0.028 ±0.013 mmol/min/LTLCp; p= 0.038. Lactate and glucose slopes were significantly correlated(r= -0.798; p< 0.001) Conclusion: During EVLP, lactate and glucose changes are linear and highly correlated over time. Glucose consumption and lactate production are significantly higher in unacceptable donor lungs and should be considered as important parameters for decision making during EVLP.
Purpose: ex vivo lung perfusion (EVLP) protocols require a delta oxygenation gradient > 350 mmHg and stable ventilatory and hemodynamic parameters to consider a lung suitable for transplantation. As centers are increasing EVLP use it is crucial that data regarding the relationship between EVLP physiology, decision to transplant and outcomes are investigated. We analyzed the NOVEL trial dataset (multicenter clinical trial of EVLP) to determine which physiologic variables during perfusion correlated to lung utilization and successful post-transplantation management. Methods: we collected EVLP and post-transplant clinical data for all donor lungs and recipients, and stratified by unilateral versus bilateral transplantation. Logistic regression was used to identify parameters during the EVLP procedure associated with likelihood of eventual organ acceptance. A similar analysis was performed to evaluate parameters associated with early post-transplant dysfunction. Results: 76 lungs were assessed with EVLP and 40 were transplanted into 42 recipients. Significant physiologic differences were observed between lungs accepted for transplant and those that were not (Table). As expected, oxygenation was associated with increased utilization. Dynamic compliance (CDyn) was also associated with transplantation and remained highly significant in multivariable analysis (p< 0.001). We sub stratified bilateral transplants into two groups by CDyn based on the median observed value during EVLP (70 liters/cmH2O). pO2 24 hrs after transplant was significantly lower in patients receiving EVLP lungs with CDyn < 70 (201 vs 381 mmHg; p= 0.003). Logistic regression revealed an increased risk of PGD grade 3 in the first 72 hrs with CDyn < 70 (OR 19.5; 95% CI 1.29-200). Conclusion: pulmonary compliance during EVLP can predict early outcomes after double lung transplant. Even in lungs deemed suitable by the investigators an EVLP, CDyn < 70 was associated with lower pO2 at 24hrs and higher incidence of significant PGD.
2( 46) A Prospective Randomized Trial of Ex Vivo Lung Perfusion in Standard Donor: Lungs: Can It Improve the Results? A. Slama, L. Schillab, M. Barta, A. Mitterbauer, K. Hötzenecker, S. Taghavi, G. Lang, J. Matilla, P. Jaksch, W. Klepetko, C. Aigner . Medical Univ of Vienna, Vienna, Austria.
The Journal of Heart and Lung Transplantation, Vol 34, No 4S, April 2015
remains poorly defined to date. We sought to describe the survival of patients with cardiac amyloidosis awaiting heart transplant with CS. Methods: Patients (n= 155) evaluated for OHT with AL or TTR cardiac amyloidosis at ten institutions were included. Data obtained via chart review was entered into the secure SSL-encrypted online database, Research Electronic Data Capture (REDCap). Patients were stratified into three groups by placement of VAD, placement of intraaortic balloon pump (IABP), or no CS. Differences between demographic and clinical characteristics were evaluated and Kaplan Meier survival estimates based on time to transplant and mortality were performed. Results: 34 of 113 (30%) AL patients required CS, 8 with VAD, 3 with biventricular assist, and 23 with IABP. Only one out of 33 (3%) TTR patients required CS (LVAD). Half of all NYHA class 4 patients required circulatory support (8 with VAD, 15 with IABP). 8 VADs were placed in patients evaluated for transplant between the year 2000 and 2008 and 4 were placed after the year 2008. Patients with VADs had higher mean PAP, PCWP, and PVR with lower LVEF and higher right ventricular stroke work index compared to those with IABP or without CS (p= 0.028). Patients with VAD were most likely to die from pump failure or multisystem organ failure, while patients with IABP were most likely to die of cardiac arrest (p= 0.001). One-year survival rate was 76% in those without CS, 52% in those with IABP, and 33% in those with VAD. There was no difference in time to death or time to transplant when stratified by no CS, IABP, and VAD (p= 0.271, p= 0.312). Conclusion: Patients with cardiac amyloidosis requiring CS have decreased survival rates compared to previously published INTERMACS data for all HF etiologies. Further investigation is needed to address the ability of VAD to provide the appropriate support for patients with cardiac amyloidosis. The poor survival of cardiac amyloid patients awaiting transplant despite CS suggests that these patients should receive priority on the waitlist. 2( 42) The Organ Care System (OCS™) Lung INSPIRE International Trial Results G. Warnecke ,1 D. Van Raemdonck,2 M. Smith,3 J. Kukreja,4 G. Loor,5 F. Rea,6 G. Massard,7 F. De Robertis,8 J. Nagendran,9 J. Moradiellos,10 K. Dhital,11 C. Knosalla,12 C. Bermudez,13 S. Tsui,14 J. Garcia,15 I. Wang,16 K. McCurry,17 F. Wagner,18 G. Leseche,19 P. Thomas,20 B. Weigmann,1 I. Tudorache,1 C. Kühn,1 M. Avsar,1 W. Sommer,1 M. Schiavon,6 N. Santelmo,7 P. Falcoz,7 A. Olland,7 T. Deuse,18 A. Varela,10 A. Simon,8 J. Madsen,15 M. Hertz,5 H. Reichenspurner,18 A. Haverich,1 A. Ardehali.21 1Hannover Medical School, Hannover, Germany; 2Leuven University Hospital, Leuven, Belgium; 3St. Joseph’s Medical Center, Phoenix, AZ; 4University of California San Francisco Medical Center, San Francisco, CA; 5University of Minnesota Medical Center, Minneapolis, MN; 6University of Padua Hospital, Padua, Italy; 7Strasbourg University Hospital, Strasbourg, France; 8Harefield Hospital, London, United Kingdom; 9University of Alberta Medical Center, Edmonton, AB, Canada; 10University Puerta de Hierro Hospital, Madrid, Spain; 11St. Vincent’s Hospital, Sydney, Australia; 12German Heart Institute, Berlin, Germany; 13University of Pittsburgh Medical Center, Pittsburgh, PA; 14Papworth Hospital, Cambridge, United Kingdom; 15Massachusetts General Hospital, Boston, MA; 16Indiana University Medical Center, Indianapolis, IN; 17Cleveland Clinic Foundation, Cleveland, OH; 18Hamburg University Hospital, Hamburg, Germany; 19Bichat Hospital, Paris, France; 20University Hospitals of Marseille, Marseille, France; 21Ronald Reagan UCLA Medical Center, Los Angeles, CA. Purpose: The OCS Lung INSPIRE Trial is a large prospective international randomized trial to evaluate the impact of using portable ex-vivo machine perfusion with OCS Lung technology to standard of care - cold storage on clinical outcomes in routine lung transplantation. Methods: INSPIRE Trial compares preservation of donor lungs using OCSLung perfusion device (Treatment Group) to Cold flush and storage (Control Group). A total of 350 primary lung transplant recipients will be randomized into the trial. Donor Inclusion Criteria: age < 65, normal gas exchange at time of final acceptance of donor lung, and no active primary pulmonary disease. Recipient Inclusion Criteria: age ≥ 18 years old; registered male or female primary double lung transplant candidate; & signed written informed consent for the trial. Donor Exclusion Criteria: positive serology; presence of moderate to severe traumatic lung injury; & presence of confirmed active
pneumonia. Recipient Exclusion Criteria: prior solid organ or bone marrow transplant; single lung recipient; chronic use of renal dialysis or diagnosed of chronic renal dysfunction; and multi-organ transplant recipient. Results: Primary study endpoint is a composite of patient survival and incidence of ISHLT Primary Graft Dysfunction (PGD) Grade 3 during the first 72 hours post-transplantation. Secondary Endpoints: Incidence of ISHLT PGD Grade 3 at 72 hours post-transplantation; Incidence of ISHLT PGD Grade 2 or 3 at 72 hours post-transplantation; Patient and graft survival at day 30. Long-term endpoints: incidence of BOS at 2 years post transplant and Pulmonary Function Tests at 6, 12, and 24 months post transplant. Conclusion: To-date 340 patients were transplanted in 21 transplant centers worldwide. We will report the final results at the ISHLT 2015 late breaking clinical trial session. 2( 43) Post EVLP Cold Preservation Period Is Associated With Clinical Outcomes E. Arango Tomas ,1 P. Sanchez,2 R.D. Davis,3 E. Cantu,4 M.J. Weyant,5 D. Lederer,1 P.C. Camp,6 B.P. Griffith,2 F. D’Ovidio.1 1Columbia University Medical Center, New York, NY; 2University of Maryland Medical Center, Baltimore, MD; 3Duke University, Durham, NC; 4University of Pennsylvania, Philadelphia, PA; 5University of Colorado Denver, Denver, CO; 6Brigham and Women’s Hospital, Boston, MA. Purpose: Ex vivo lung perfusion (EVLP) is changing the lung preservation paradigm. Standard cold preservation is followed by normothermic EVLP, then lungs undergo a second cold preservation prior to implantation. We recently demonstrated that high-risk lungs re-assessed by EVLP have similar outcomes to standard criteria lungs. Nevertheless a paucity of data exist on how the sequence of cold-normothermic-cold preservations affect outcomes. We investigated the effects of preservation times in transplanted EVLP lungs. Methods: Data from the NOVEL trial was retrospectievly analyzed. Duration of the 3 preservation phases was measured: cold pre EVLP; EVLP; cold post EVLP. Donor & recipient clinical data were collected. Primary graft dysfunction (PGD) and 1 year mortality were monitored. Results: Complete data was obtained on 42 pts transplanted post EVLP. At 72hrs PGD 2 was present in 5/42 (12%) and PGD3 in 4/42 (9%). One-year mortality was 6/42 (16%). Using a 75th percentile cut-off time a cold post EVLP time ≥ 322min was considered Extended. ROC method confirmed cutoff for accuracy towards PGD or 1-yr mortality. Logistic regression analysis for Extended cold post-EVLP preservation and PGD (2 or 3) at 72hrs showed OR 11.2 (95%CI 2.1-60.2) p< 0.005, and when adjusted for normothermic EVLP time OR= 9 (95% CI 1.4-46.8) p= 0.02. Cox proportional analysis for 1 year survival showed HR 15 (95%CI 1.7-129) p= 0.01, and when adjusted for EVLP time HR 18 (95% 1.9-176) p= 0.01. Tables shows the Chi square analysis (Fisher’s test p< 0.05). No association was noted with the cold pre EVLP preservation. Conclusion: Cold preservation post EVLP seems to adversely impact on clinical outcomes. In particular, extended (> 5hrs) duration of cold post EVLP preservation times associated with a significantly greater risk for PGD and one-year mortality. These preliminary findings from a small cohort of patients in a multicenter trial need to be confirmed in a larger cohort, although should caution on the implementation of extended duration of cold preservation post EVLP.
Abstracts S97 2( 44)
2( 45)
Metabolic Assessment of Marginal Donor Lungs During Ex-Vivo Perfusion (EVLP): New Parameters for Decision Making A. Slama , M. Barta, L. Schillab, A. Mitterbauer, P. Jaksch, K. Hoetzenecker, W. Klepetko, C. Aigner. Medical Univ of Vienna, Vienna, Austria.
Lung Compliance During Ex Vivo Lung Perfusion Predicts Early Post Transplant Outcomes P.G. Sanchez ,1 G.J. Bittle,1 E. Cantu III,2 F. D Ovidio,3 M. Weyant,4 R.D. Davis,5 B.P. Griffith.1 1Cardiac Surgery, University of Maryland, Baltimore, MD; 2Cardiac Surgery, University of Pennsylvania, Philadelphia, PA; 3Thoracic Surgery, Columbia University, New York, NY; 4Thoracic Surgery, University of Colorado, Aurora, CO; 5Cardiac Surgery, Duke University, Durham, NC.
Purpose: EVLP has become a widespread method to evaluate marginal donor lungs. Nevertheless, strong evidence on accurate judgment of graft quality by individual functional parameters is still missing. Anaerobic glucose metabolism might be dependent on graft quality and serve as a parameter for decision making during EVLP. Methods: This is an analysis of our prospective EVLP database. Since 2010, 43 EVLP were performed with initially rejected marginal donor lungs. 28 (65%) of these lungs were accepted after EVLP and transplanted with results comparable to standard donor lungs. Absolute glucose consumption and lactate production were calculated and corrected for hourly changes of perfusate and additional glucose administration. These values were compared between accepted (group A) and rejected lungs (group B). Linear regression was performed and the slope values were indexed for donor pTLC to correct for graft size. Results: Mean EVLP Duration was 275±87 min. (group A, n= 28) vs. 297 min. (group B, n= 15: 238 min; p= 0.039). Subsequently accepted lungs showed a significantly lower total glucose consumption (T1h:-899 vs.-1258 mg; p= 0.29/ T2h:-1625 vs.-2293 mg; p= 0.058/ T3h: 2432 vs.-3380 mg; p= 0.015/ T4h:-2812 vs.-4771 mg; p< 0.001) and lower lactate production (T1h:7.5 vs.9.5mmol; p= 0.44/ T2h: 15 vs. 19.6 mmol; p= 0.09/ T3h: 22.3 vs. 29 mmol; p= 0.02/ T4h:27 vs. 42.7mmol; p< 0.001). In linear regression analysis glucose consumption and lactate production slopes were significantly different between the groups (glucose:-2.03 ±1.03 vs.-3.06 ±1.41 mg/min/ LTLCp;p= 0.021/ lactate: 0.019 ±0.008 vs. 0.028 ±0.013 mmol/min/LTLCp; p= 0.038. Lactate and glucose slopes were significantly correlated(r= -0.798; p< 0.001) Conclusion: During EVLP, lactate and glucose changes are linear and highly correlated over time. Glucose consumption and lactate production are significantly higher in unacceptable donor lungs and should be considered as important parameters for decision making during EVLP.
Purpose: ex vivo lung perfusion (EVLP) protocols require a delta oxygenation gradient > 350 mmHg and stable ventilatory and hemodynamic parameters to consider a lung suitable for transplantation. As centers are increasing EVLP use it is crucial that data regarding the relationship between EVLP physiology, decision to transplant and outcomes are investigated. We analyzed the NOVEL trial dataset (multicenter clinical trial of EVLP) to determine which physiologic variables during perfusion correlated to lung utilization and successful post-transplantation management. Methods: we collected EVLP and post-transplant clinical data for all donor lungs and recipients, and stratified by unilateral versus bilateral transplantation. Logistic regression was used to identify parameters during the EVLP procedure associated with likelihood of eventual organ acceptance. A similar analysis was performed to evaluate parameters associated with early post-transplant dysfunction. Results: 76 lungs were assessed with EVLP and 40 were transplanted into 42 recipients. Significant physiologic differences were observed between lungs accepted for transplant and those that were not (Table). As expected, oxygenation was associated with increased utilization. Dynamic compliance (CDyn) was also associated with transplantation and remained highly significant in multivariable analysis (p< 0.001). We sub stratified bilateral transplants into two groups by CDyn based on the median observed value during EVLP (70 liters/cmH2O). pO2 24 hrs after transplant was significantly lower in patients receiving EVLP lungs with CDyn < 70 (201 vs 381 mmHg; p= 0.003). Logistic regression revealed an increased risk of PGD grade 3 in the first 72 hrs with CDyn < 70 (OR 19.5; 95% CI 1.29-200). Conclusion: pulmonary compliance during EVLP can predict early outcomes after double lung transplant. Even in lungs deemed suitable by the investigators an EVLP, CDyn < 70 was associated with lower pO2 at 24hrs and higher incidence of significant PGD.
2( 46) A Prospective Randomized Trial of Ex Vivo Lung Perfusion in Standard Donor: Lungs: Can It Improve the Results? A. Slama, L. Schillab, M. Barta, A. Mitterbauer, K. Hötzenecker, S. Taghavi, G. Lang, J. Matilla, P. Jaksch, W. Klepetko, C. Aigner . Medical Univ of Vienna, Vienna, Austria.