Purpose The TOP Registry is a multi-center, all-inclusive observational registry that was established to collect perfusion parameters and post-transplant clinical outcomes for lung transplants performed with donor lungs perfused and assessed on the OCS Lung system in the commercial setting. Methods Registry outcomes were categorized into three groups according to the prespecified analysis populations: Standard criteria donor (SCD), extended criteria donor (ECD), and Other which included retransplants, multi-organ transplants and single lung recipients. All data were prospectively collected and verified in the Registry database. Results At time of submission, 318 patients were transplanted using the OCS Lung system. Complete data on 262 OCS recipients was available for analysis. Of these, 70 (26.7%) were SCD, 137 (52.3%) were ECD, and 55 (20.9%) were Other. Donor and recipient characteristics and risk factors were similar between the groups. Kaplan-Meier survival analysis through 1-year post-transplant showed 85.7% for SCD, 82% for ECD, and 80% for Other (p=0.654) Figure 1. Cox regression analysis demonstrated that recipients' LAS score at transplantation was a significant independent predictor for mortality (p=0.012) Figure 2. Conclusion This initial report of the TOP Registry shows that the OCS Lung system has been used predominantly in ECD lungs but also in a variety of other scenarios including SCD, multiorgan, retransplants, and single lung transplants. Outcomes in all scenarios were comparable to contemporary lung transplantation in the US with survival determined primarily by the recipient's degree of illness rather than the characteristics of the donor.

Purpose National OCS Lung Procurement (NOP) of donor lungs utilizes a national network of dedicated cardiothoracic surgical procurement and OCS perfusion experts to procure, perfuse and assess donor lungs from donors to recipients. Using the TOP Registry data, this report compared post-transplant outcomes for lung transplanted using NOP vs traditional center-driven procurement and management of OCS Lung perfusion (Direct). Methods The TOP registry is a multi-center, all-inclusive observational registry that was established to collect perfusion parameters and post-transplant clinical outcomes for lung transplants performed with donor lungs perfused and assessed on the OCS Lung system. We evaluated the impact of OCS Lung NOP on post-transplant survival in the TOP Registry patient cohort to discern any clinical correlation. We stratified the TOP Registry data between December 2019 and June 2022 into two groups; NOP group and Direct group. Results Data from 262 OCS Lung transplant recipients in the registry were available for analysis. Of these, 108 patients were in NOP group and 154 patients were in the Direct group. Significant differences were seen in total cross-clamp times NOP 638 (range 285-1,886 mins) vs. Direct 548 mins (range 274-971 mins) (p=0.004); and total OCS perfusion time NOP 471 mins (range 162-1624 mins) vs. Direct 384 mins (range 27-858 mins) (p=0.004). The 1-year survival, probability was 84.8% in the NOP group, and 81.4% in the Direct group (Log-rank p=0.436 - Figure 1) Conclusion NOP enabled distant procurement of donor lungs while resulting in similar survival outcomes compared to traditional direct method. This finding demonstrates that NOP is a valid method to enable lung transplant programs to expand their capability to utilize donor lungs from outside the historical standard acceptance radius. Importantly, the NOP could enable better manage transplant procedure logistics and clinical staffing.

Purpose: Disorders of the esophagus including gastroesophageal reflux (GERD), and impaired esophageal motility have been linked to worse outcomes following lung transplant. At the present time the optimal approach to characterizing risk from esophageal disorders remains unknown. Methods: we conducted a retrospective study of lung transplant recipients performed at our institution with the primary outcome of Bronchiolitis Obliterans Syndrome (BOS). We assessed the risks of stage 1 BOS based on the presence of GERD defined by barium esophagram or by 24 hr esophageal pH monitoring. We further assessed the risk of BOS based on a diagnosis of esophageal dysmotility diagnosed by manometry. We assessed outcomes on 157 patients transplanted between 2005 and 2012 who had at least one year of followup. Of this cohort, 152 patients had a barium esophagram prior to transplantation, 114 patients had a 24 hr pH probe, and 138 patients had post transplant esophageal manometry. GERD was defined as any reflux seen on esophagram, and by a DeMeester score higher than median value of our population. Dysmotility was defined by ≥50% dropped contractions, achalasia or high resting lower esophageal sphincter tone (nutcracker esophagus). Results: Patients with esophageal dysmotility had a 2 fold higher incidence of stage 1 BOS at 2 years compared to patients with normal motility (31% vs 16%, p=.05). In contrast, patients with GERD by esophagram or by 24 hr pH probe had slightly higher risk of BOS, but this effect did not reach statistical significance. When assessed longitudinally with a median time of followup of 842 days, there was a trend toward increased risk of BOS in patients with dysmotility, but this was not statistically significant (p=.29). Conclusions: Of all the metrics used to assess esophageal disorders after lung transplantation, assessment by manometry appears to have the highest correlation with development of early BOS. Given significant overlap between patients having abnormal manometry and GERD, additional studies are needed to illuminate which combination of esophageal disorders carry the highest risk.

Historically, patients with pulmonary arterial hypertension (PAH) have been treated with bilateral lung translation (BLT) for physiologic reasons. However, some patients with PAH may not be candidates for BLT and it is unknown whether single lung transplantation (SLT) can be performed safely in those patients. Our study compared survival in SLT versus BLT patients stratified to differing levels of mean PAH. We reviewed the UNOS database for patients with emphysema, pulmonary fibrosis, and primary PAH transplanted since 2004. Propensity scores (PS) were generated to adjust for factors that could bias the type of transplant procedure.PS-adjusted Cox proportional hazards regression models were constructed to measure type of surgery and PAH effects (normal< 26mmHg, mild 26-35, moderate 35-45, severe>45). 6923 patients met criteria for analysis. 3139 (45%) patients underwent SLT versus 3784 (55%) BLT. PAH was classified as normal in 3757 (54%), mild in 2217 (32%), moderate in 554 (8%), and severe in 395 (6%) patients. There was a survival advantage for BLT versus SLT at 1,3,5 and 8 years (90.3%vs88.5%,72.8vs67. 2%, 60.5vs51.8%, 44vs34.1%, p<0.001). Full regression adjustment demonstrated a 14% decrease in risk of mortality in the BLT group (HR=0.86, 95% CI 0.78-0.95,p=0.004). Patients with severe PAH had increased mortality (HR=1.30, p=.016). There was no additional effect on survival when type of transplant was analyzed with varying degrees of PAH. (Table, Graph) Patients receiving BLT, compared to SLT, have a significant survival advantage independent of the degree of PAH and patients with severe PAH have overall worse survival compared to other recipients. Our study failed to show any interaction between the type of transplant performed and degree of PAH with respect to survival. This data suggests that it may be safe to perform SLT on patients with PAH whoare not felt to be candidates for BLT.TableInteraction of PAH and Type of Transplant on SurvivalModel TermUnadjustedPropensity Selection AdjustmentPropensity Full Regression AdjustmentFull RegressionAdjustmentDouble vs. Single0.99 (0.90-1.09) p=0.860.88 (0.90-0.98) p=0.0190.88 (0.79-0.97) p=0.0130.86 (0.78-0.95) p=0.004PAH: Mild vs. Normal0.99 (0.90-1.09) p=0.861.04 (0.94-1.15) p=0.441.04 (0.94-1.14) p=0.471.00 (0.91-1.11) p=0.93PAH: Moderate vs. Normal1.05 (0.89-1.24) p=0.591.14 (0.96-1.35) p=0.131.13 (0.96-1.35) p=0.151.03 (0.87-1.22) p=0.76PAH: Severe vs. Normal1.11 (0.91-1.35) p=0.291.27 (1.04-1.57) p=0.0221.26 (1.03-1.55) p=0.0271.30 (1.05-1.60) p=0.016PAH and SurgeryType:Evidence of InteractionNone, p=0.74None, p=0.80None, p=0.80None, p=0.72 Open table in a new tab

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