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Assessment of Human Lungs Recovered From Uncontrolled Donation After Circulatory Determination of Death (uDCDD) Donors By Ex-Vivo Lung Perfusion (EVLP) and CT Scan
Abstracts S247 with a median age of 67 (IQR 63-70), and a median FEV1 percent predicted of 26 (IQR 20-33). Fifty-seven patients were frail. The prevalence of frailty was six percent with an incidence of frailty of five percent per year. Frail patients had a worse survival with a Hazard Ratio (HR) of 1.57 (CI 1.08-2.29; p= 0.018), decreased time to hospitalization HR of 1.70 (CI 1.11-2.59; p= 0.014), and increased hospital days (estimated increase of 8 days; CI 5.3-10.7; p< 0.0001) after adjusting for age, lung volume reduction surgery, FEV1 and dyspnea score. Conclusion: The frailty phenotype is common in COPD and is associated with worsened survival and increased hospital days. Lung transplant physicians should consider the risk of frailty when determining transplant eligibility. 6( 68) 100 Lung Transplants Delivered in Ireland A. Gough , A. Wood, J. McCarthy, L. Nolke, H. DG, K. Redmond, D. Eaton, H. Javadpour, J. Egan. Cardiothoraic Transplant, Mater Misericordiae University Hospital, Dublin, Ireland. Purpose: The lung transplant program started in Ireland in 2005. From that point the burden of service delivery was gradually transferred from the prior provider (UK), to a full local national service. By 2014 the program was delivered exclusively through the national service. We report on the first 100 cases. Methods: We performed a retrospective and descriptive analysis of the data collected from medical and electronic patient records in 100 patients who underwent lung transplantion in the Mater Hospital from 2005 to 2014. All transplants were performed from deceased donors and included single and bilateral sequential lung transplants. Patient followup was at 30 days, 1 year and 5 years. Data collected included epidemiological aspects such as age and sex, aetiology of disease. Results: The average age was 49.41 years (range 18.45-72.49) and 67 were male. There were 52 single and 48 bilateral sequential lung transplants. The indications for transplant were: IPF (40), Cystic Fibrosis (28), Emphysema/ COPD (20) and others including alpha 1 anti-trypsin deficiency (4), lymphangioleiomyomatosis (LAM) (2), bronchiolitis obliterans syndrome(BOS) (2), Pulmonary hypertension (2), Sjorgens disease (1) and Sarcoidosis (1). There has been a steady increase in the number delivered in each year with 32 in 2013 alone. The 30 day, 1 year and 5 year survival were 99%, 98% and 80% respectively. Conclusion: This new program has delivered steady progress from 2005 to 2014 where it is delivering transplantation services in numbers not previously delivered to Irish patients. Clinical outcomes are excellent and compare favourably with international standards. 6( 69) Combined Lung-Kidney Transplantation: An Analysis of the UNOS/OPTN Database H.J. Reich ,1 J.L. Chan,2 L. Czer,3 J. Mirocha,4 A. Annamalai,5 W. Cheng,6 S.C. Jordan,7 G. Chaux,8 D. Ramzy.6 1Surgery, Heart Institute, CedarsSinai Medical Center, Los Angeles, CA; 2Surgery, Cedars-Sinai Medical Center, Los Angeles, CA; 3Cardiology, Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA; 4Biostatistics and Bioinformatics, Cedars-Sinai Medical Center, Los Angeles, CA; 5Surgery, Comprehensive Transplant Center, Cedars-Sinai Medical Center, Los Angeles, CA; 6Cardiothoracic Surgery, Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA; 7Nephrology, Comprehensive Transplant Center, Cedars-Sinai Medical Center, Los Angeles, CA; 8Pulmonology and Critical Care, Lung Transplant Center, Cedars-Sinai Medical Center, Los Angeles, CA. Purpose: Poor outcomes after thoracic transplant with concurrent renal dysfunction are well-described: without transplant or with thoracic-only transplant, such patients face unacceptably high mortality. Although combined lung-kidney transplantation (LKT) remains a rare operation, it is performed with increasing frequency. Patient outcomes following LKT remain uninvestigated. We hypothesize that patient survival after LKT is similar to survival after LT & inferior to survival after kidney-only transplantation (KT).
Methods: The UNOS/OPTN database was queried to identify all LKT, LT, and KT performed in the U.S. from 1995-2013. Survival was calculated using the Kaplan-Meier method & compared using log-rank tests or Cox regression models. Results: Thirty-one LKT, including 3 heart-lung-kidney transplants, were performed. Median follow-up was 14.46 months (19 days - 8.51 years). The mean age of LKT recipients was 44.8 ± 13.1 years & 48% were male. Redo lung transplant for graft failure was the leading indication for LT (n= 13), followed by cystic fibrosis (n= 4). The most common renal indication was calcineurin inhibitor nephrotoxicity (n= 11). Mean lung allocation score (LAS) was 46.6 ± 14.4. No patient required extracorporeal membrane oxygenation. Mean creatinine was 3.7 ± 2.8 mg/dL, MDRD estimated GFR was 26.1 ± 17.6 mL/min/1.73m2, & 11 patients were dialysis-dependent. Ischemic time for lung & kidney grafts was 4.6 ± 1.7 & 12.6 ± 8.1 hours. Patient survival after LKT was 93%, 71%, & 71% at 1 month, 6 months, & 1 year with median survival 95.2 months. Relative to single-organ transplant, 1 & 5 year survival after LKT, 71% & 60%, were similar to LT (n= 23,913), 82% & 51% (p = 0.061 & 0.55), & inferior to KT (n= 175,269), 95% & 83% (p < 0.0001). Outcomes improved in the LAS era: 1 & 5 year survival for LKT (n= 23) were 78% & 72% & remained similar to LT (n= 12,755), 84% & 53% (p = 0.30 & 0.88). Redo status did not increase mortality after LKT at 1 (HR 1.05, 95% CI [0.28, 3.93] & 4 years (HR 1.18 [0.36, 3.88]), in contrast to significantly increased mortality after LT: HR 1.89 [1.68, 2.14] & HR 1.75 [1.60,1.92]. Conclusion: This is the first study to describe outcomes after lung-kidney transplantation. Patient survival following lung-kidney transplant is similar to lung-only transplant & is an acceptable option for lung-transplant candidates with significant renal dysfunction. 6( 70) Assessment of Human Lungs Recovered From Uncontrolled Donation After Circulatory Determination of Death (uDCDD) Donors By Ex-Vivo Lung Perfusion (EVLP) and CT Scan T.M. Egan ,1 J. Blackwell,1 S. Gazda,1 L. Forrest,1 B. Haithcock,1 J. Long,1 K. Birchard,2 S. Reddy,3 N. Casey.4 1Surgery, U. North Carolina Sch Med, Chapel Hill, NC; 2Radiology, U. North Carolina Sch Med, Chapel Hill, NC; 3Surgery, Duke University, Durham, NC; 4Carolina Donor Services, Durham, NC. Purpose: We hypothesized that lungs recovered after death from uDCDD donors (uDCDDs) could be suitable for lung transplant (LTX). We report outcomes of lungs recovered from 14 uDCDDs assessed by EVLP and CT scan. Methods: Over 13 months, 123 potential uDCDDs < 66 yrs old were available. After consent and medical screening, uDCDDs were ventilated with O2, and transported for lung recovery with antegrade and retrograde cold Perfadex™ flush. After cold ischemic time (to allow obtaining serologies), some lungs were evaluated by EVLP (Toronto method). After EVLP, lungs were cooled, flushed with cold Perfadex™, and had ex-vivo CT scan. Results: For 20 potential uDCDDs, NOK were not identified within 2 hrs, and 21 NOK declined donation (8 registered donors). After medical screening of 82 potential uDCDDs, lungs were recovered from 14. EVLP was performed in 8. See Table for outcomes. Reasons for not performing EVLP on recovered lungs: consent rescinded after recovery (Case 4); one prolonged warm ischemic time (Case 6 - 2nd marathon runner, family and circumstances delayed recovery); severe lung injury (3) - one large pulmonary infarct with a lung perforation at recovery (Case 7) - cause of death was likely pulmonary embolism; 2 MVCs with lung punctures and severe contusions (Cases 13 & 14); and 1 technical pump failure (Case 9 - no consented recipient). Lungs from 1 uDCDD were judged transplantable (Case 11), but there was no blood-type size-appropriate consented recipient. Two donors may have died hours before resuscitation (Cases 2 & 8). Conclusion: Although > 4 hr warm ischemia was associated with poor performance during EVLP, more experience is needed to better define the limits of ischemic time. Strategies to honor first person consent would increase the number of potential uDCDDs and reduce warm ischemic time. Both could increase yield of lungs from uDCDDs, which may provide more lungs for transplant. Ex-vivo CT scan adds useful evaluation information.
S248
The Journal of Heart and Lung Transplantation, Vol 34, No 4S, April 2015 6( 72)
uDCDD EVLP Outcomes Age/ Case # Sex Ischemic Time (min)
EVLP Duration & Outcome
Comment
ex-vivo CT scan
warm warm cold O2unvent vent 1
54 M 27
141
578
2
60 M 55
115
317
3
59 M 38
132
313
5
31 M 125
148
486
6
35 M 195
236
8
53 F
129
493
10
57 M 123
128
578
11 12
47 M 51 64 M 45
152 139
658 663
55
2 hr; poor collapse; visible blebs; pO2= 452 perhaps > 2 hr downtime before CPR unclear why
4 hr; poor oxygenation 2 hr; pulm marathon edema runner #1 not done, much 2nd marathon longer ischemic runner time ? > 3 hr 1 hr, poor downtime oxygenation, before CPR pulm edema 0 hr; immediate ? long ischemic pulm edema time 4 hr; excellent 4 hr; excellent gasses
transplantable lungs felt "doughy"; 10 yr hx CHF
emphysema
dependent edema mild edema pulm edema pulm edema with Perfadex flush dependent edema pulm edema mostly L side -?technical? minimal edema widespread edema;? chronic?
6( 71) Enhanced Donor Organ Quality Assurance Using Novel Point-of-View Video Streaming Technology During Harvesting A.C. Baldwin ,1 H.R. Mallidi,2 W.E. Cohn,2 G. Dronavalli,3 A.D. Parulekar,3 S.K. Singh.2 1Surgery, Yale School of Medicine, New Haven, CT; 2Transplant and Assist Devices, Baylor College of Medicine, Houston, TX; 3Pulmonary Medicine and Pulmonary Transplant, Baylor College of Medicine, Houston, TX. Purpose: Our aim was to evaluate the feasibility and educational potential of a novel point-of-view technology (Google Glass™) to improve donor organ procurement via remote, real-time intra-operative feedback. Methods: A single resident surgeon was trained to use the Explorer Edition Google Glass (Google Inc., Mountain View, CA), a wearable ‘smart’ camera chosen for its heads-up display, hands-free capability, and wireless connectivity. Intraoperative use focused on integration of heads-up software and live video streaming. Surgical checklists for organ procurement procedures were uploaded to a secure Google Drive™ folder and accessed by the Glass™ headset display to validate casespecific milestones. Video streaming was enabled using Livestream™ software (Livestream, Brooklyn, NY), broadcast to a secure website accessible via desktop and smartphone displays. Primary outcomes consisted of technological feasibility, adherence to methodology, application to resident training, and demonstration of safety and quality assurance during organ procurement. Results: Four consecutive donor harvests (2 heart, 1 double-lung, 1 singlelung) were divided into components of organ visualization, harvesting, and post-harvest back-table review and preparation. The method of use proved feasible, with proper adherence in all cases. Hands-free voice commands allowed for sterile manipulation of both the camera and heads-up checklist display. In each case, a supervising physician was able to successfully observe the video feed and provide real time communication of feedback. All recorded media was stored for retrospective individual and peer review and the compilation of a multimedia database, establishing the feasibility of practical and high-fidelity performance assessments. No surgical complications occurred during the course of the series, and patient safety and quality assurance was maintained. Conclusion: This is the first reported clinical application of wearable technology to provide both real-time video streaming and live-action checklist confirmation for the purpose of enhanced resident training and donor organ harvest quality assurance.
Long-Term Outcome After Lung Transplantation Is Comparable Between Brain-Dead and Cardiac-Dead Donors D. Ruttens , S. Verleden, E. Vandermeulen, H. Bellon, J. Somers, A. Martens, N. Arne, L. Dupont, B. Vanaudenaerde, R. Vos, D. Van Raemdonck, G. Verleden. KULeuven, Leuven, Belgium. Purpose: Donation after cardiac death (DCD) to overcome the donor organ shortage is well accepted in the clinical setting, although the longterm outcome after DCD lung transplantation (LTx) remains largely unknown. Methods: In this retrospective study, DCD LTx recipients (n= 59) were compared with a cohort of donation-after-brain-death (DBD) LTx recipients (n= 331) transplanted between February 2007 and September 2013. Survival and incidence of chronic lung allograft dysfunction (CLAD), were assessed and compared over a median follow-up of 33.4 (±2.8) months for DCD and 40.7 (±2.8) months for DBD(p= 0.049). Results: There were no differences between groups with regard to patient characteristics: age (p= 0.78), underlying disease (p= 0.30) and type of type of LTx (p= 0.10); Except for gender more male predominance was seen in the DCD group (37 of 59(62%) vs 160 of 331(48%)) (p= 0.048). Nine patients (15%) in the DCD group developed CLAD vs 65 patients (20%) in the DBD group (p= 0.48). Freedom from CLAD did not differ between the groups (p= 0.90, figure). In the DCD group, 14 of 59 patients (24%) died, vs 62 of 331 patients (19%) in the DBD group (p= 0.38). Actuarial survival rates 1 year, 3 years and 5 years are 88%, 75% and 71% for the DCD group and 91%, 84% and 80% for the DBD group (p= 0.13, figure). Conclusion: In our experience, long-term outcome in DCD lung recipients is comparable to that of DBD lung recipients.
Methods: The UNOS/OPTN database was queried to identify all LKT, LT, and KT performed in the U.S. from 1995-2013. Survival was calculated using the Kaplan-Meier method & compared using log-rank tests or Cox regression models. Results: Thirty-one LKT, including 3 heart-lung-kidney transplants, were performed. Median follow-up was 14.46 months (19 days - 8.51 years). The mean age of LKT recipients was 44.8 ± 13.1 years & 48% were male. Redo lung transplant for graft failure was the leading indication for LT (n= 13), followed by cystic fibrosis (n= 4). The most common renal indication was calcineurin inhibitor nephrotoxicity (n= 11). Mean lung allocation score (LAS) was 46.6 ± 14.4. No patient required extracorporeal membrane oxygenation. Mean creatinine was 3.7 ± 2.8 mg/dL, MDRD estimated GFR was 26.1 ± 17.6 mL/min/1.73m2, & 11 patients were dialysis-dependent. Ischemic time for lung & kidney grafts was 4.6 ± 1.7 & 12.6 ± 8.1 hours. Patient survival after LKT was 93%, 71%, & 71% at 1 month, 6 months, & 1 year with median survival 95.2 months. Relative to single-organ transplant, 1 & 5 year survival after LKT, 71% & 60%, were similar to LT (n= 23,913), 82% & 51% (p = 0.061 & 0.55), & inferior to KT (n= 175,269), 95% & 83% (p < 0.0001). Outcomes improved in the LAS era: 1 & 5 year survival for LKT (n= 23) were 78% & 72% & remained similar to LT (n= 12,755), 84% & 53% (p = 0.30 & 0.88). Redo status did not increase mortality after LKT at 1 (HR 1.05, 95% CI [0.28, 3.93] & 4 years (HR 1.18 [0.36, 3.88]), in contrast to significantly increased mortality after LT: HR 1.89 [1.68, 2.14] & HR 1.75 [1.60,1.92]. Conclusion: This is the first study to describe outcomes after lung-kidney transplantation. Patient survival following lung-kidney transplant is similar to lung-only transplant & is an acceptable option for lung-transplant candidates with significant renal dysfunction. 6( 70) Assessment of Human Lungs Recovered From Uncontrolled Donation After Circulatory Determination of Death (uDCDD) Donors By Ex-Vivo Lung Perfusion (EVLP) and CT Scan T.M. Egan ,1 J. Blackwell,1 S. Gazda,1 L. Forrest,1 B. Haithcock,1 J. Long,1 K. Birchard,2 S. Reddy,3 N. Casey.4 1Surgery, U. North Carolina Sch Med, Chapel Hill, NC; 2Radiology, U. North Carolina Sch Med, Chapel Hill, NC; 3Surgery, Duke University, Durham, NC; 4Carolina Donor Services, Durham, NC. Purpose: We hypothesized that lungs recovered after death from uDCDD donors (uDCDDs) could be suitable for lung transplant (LTX). We report outcomes of lungs recovered from 14 uDCDDs assessed by EVLP and CT scan. Methods: Over 13 months, 123 potential uDCDDs < 66 yrs old were available. After consent and medical screening, uDCDDs were ventilated with O2, and transported for lung recovery with antegrade and retrograde cold Perfadex™ flush. After cold ischemic time (to allow obtaining serologies), some lungs were evaluated by EVLP (Toronto method). After EVLP, lungs were cooled, flushed with cold Perfadex™, and had ex-vivo CT scan. Results: For 20 potential uDCDDs, NOK were not identified within 2 hrs, and 21 NOK declined donation (8 registered donors). After medical screening of 82 potential uDCDDs, lungs were recovered from 14. EVLP was performed in 8. See Table for outcomes. Reasons for not performing EVLP on recovered lungs: consent rescinded after recovery (Case 4); one prolonged warm ischemic time (Case 6 - 2nd marathon runner, family and circumstances delayed recovery); severe lung injury (3) - one large pulmonary infarct with a lung perforation at recovery (Case 7) - cause of death was likely pulmonary embolism; 2 MVCs with lung punctures and severe contusions (Cases 13 & 14); and 1 technical pump failure (Case 9 - no consented recipient). Lungs from 1 uDCDD were judged transplantable (Case 11), but there was no blood-type size-appropriate consented recipient. Two donors may have died hours before resuscitation (Cases 2 & 8). Conclusion: Although > 4 hr warm ischemia was associated with poor performance during EVLP, more experience is needed to better define the limits of ischemic time. Strategies to honor first person consent would increase the number of potential uDCDDs and reduce warm ischemic time. Both could increase yield of lungs from uDCDDs, which may provide more lungs for transplant. Ex-vivo CT scan adds useful evaluation information.
S248
The Journal of Heart and Lung Transplantation, Vol 34, No 4S, April 2015 6( 72)
uDCDD EVLP Outcomes Age/ Case # Sex Ischemic Time (min)
EVLP Duration & Outcome
Comment
ex-vivo CT scan
warm warm cold O2unvent vent 1
54 M 27
141
578
2
60 M 55
115
317
3
59 M 38
132
313
5
31 M 125
148
486
6
35 M 195
236
8
53 F
129
493
10
57 M 123
128
578
11 12
47 M 51 64 M 45
152 139
658 663
55
2 hr; poor collapse; visible blebs; pO2= 452 perhaps > 2 hr downtime before CPR unclear why
4 hr; poor oxygenation 2 hr; pulm marathon edema runner #1 not done, much 2nd marathon longer ischemic runner time ? > 3 hr 1 hr, poor downtime oxygenation, before CPR pulm edema 0 hr; immediate ? long ischemic pulm edema time 4 hr; excellent 4 hr; excellent gasses
transplantable lungs felt "doughy"; 10 yr hx CHF
emphysema
dependent edema mild edema pulm edema pulm edema with Perfadex flush dependent edema pulm edema mostly L side -?technical? minimal edema widespread edema;? chronic?
6( 71) Enhanced Donor Organ Quality Assurance Using Novel Point-of-View Video Streaming Technology During Harvesting A.C. Baldwin ,1 H.R. Mallidi,2 W.E. Cohn,2 G. Dronavalli,3 A.D. Parulekar,3 S.K. Singh.2 1Surgery, Yale School of Medicine, New Haven, CT; 2Transplant and Assist Devices, Baylor College of Medicine, Houston, TX; 3Pulmonary Medicine and Pulmonary Transplant, Baylor College of Medicine, Houston, TX. Purpose: Our aim was to evaluate the feasibility and educational potential of a novel point-of-view technology (Google Glass™) to improve donor organ procurement via remote, real-time intra-operative feedback. Methods: A single resident surgeon was trained to use the Explorer Edition Google Glass (Google Inc., Mountain View, CA), a wearable ‘smart’ camera chosen for its heads-up display, hands-free capability, and wireless connectivity. Intraoperative use focused on integration of heads-up software and live video streaming. Surgical checklists for organ procurement procedures were uploaded to a secure Google Drive™ folder and accessed by the Glass™ headset display to validate casespecific milestones. Video streaming was enabled using Livestream™ software (Livestream, Brooklyn, NY), broadcast to a secure website accessible via desktop and smartphone displays. Primary outcomes consisted of technological feasibility, adherence to methodology, application to resident training, and demonstration of safety and quality assurance during organ procurement. Results: Four consecutive donor harvests (2 heart, 1 double-lung, 1 singlelung) were divided into components of organ visualization, harvesting, and post-harvest back-table review and preparation. The method of use proved feasible, with proper adherence in all cases. Hands-free voice commands allowed for sterile manipulation of both the camera and heads-up checklist display. In each case, a supervising physician was able to successfully observe the video feed and provide real time communication of feedback. All recorded media was stored for retrospective individual and peer review and the compilation of a multimedia database, establishing the feasibility of practical and high-fidelity performance assessments. No surgical complications occurred during the course of the series, and patient safety and quality assurance was maintained. Conclusion: This is the first reported clinical application of wearable technology to provide both real-time video streaming and live-action checklist confirmation for the purpose of enhanced resident training and donor organ harvest quality assurance.
Long-Term Outcome After Lung Transplantation Is Comparable Between Brain-Dead and Cardiac-Dead Donors D. Ruttens , S. Verleden, E. Vandermeulen, H. Bellon, J. Somers, A. Martens, N. Arne, L. Dupont, B. Vanaudenaerde, R. Vos, D. Van Raemdonck, G. Verleden. KULeuven, Leuven, Belgium. Purpose: Donation after cardiac death (DCD) to overcome the donor organ shortage is well accepted in the clinical setting, although the longterm outcome after DCD lung transplantation (LTx) remains largely unknown. Methods: In this retrospective study, DCD LTx recipients (n= 59) were compared with a cohort of donation-after-brain-death (DBD) LTx recipients (n= 331) transplanted between February 2007 and September 2013. Survival and incidence of chronic lung allograft dysfunction (CLAD), were assessed and compared over a median follow-up of 33.4 (±2.8) months for DCD and 40.7 (±2.8) months for DBD(p= 0.049). Results: There were no differences between groups with regard to patient characteristics: age (p= 0.78), underlying disease (p= 0.30) and type of type of LTx (p= 0.10); Except for gender more male predominance was seen in the DCD group (37 of 59(62%) vs 160 of 331(48%)) (p= 0.048). Nine patients (15%) in the DCD group developed CLAD vs 65 patients (20%) in the DBD group (p= 0.48). Freedom from CLAD did not differ between the groups (p= 0.90, figure). In the DCD group, 14 of 59 patients (24%) died, vs 62 of 331 patients (19%) in the DBD group (p= 0.38). Actuarial survival rates 1 year, 3 years and 5 years are 88%, 75% and 71% for the DCD group and 91%, 84% and 80% for the DBD group (p= 0.13, figure). Conclusion: In our experience, long-term outcome in DCD lung recipients is comparable to that of DBD lung recipients.