Introduction of the Lung Allocation Score in Germany

J. Gottlieb; M. Greer; U. Sommerwerck; T. Deuse; C. Witt; R. Schramm; C. Hagl; M. Strueber; J. M. Smits

American Journal of Transplantation. 2014;14(6):1318-1327.

Abstract and Introduction

Abstract

The aim of this study was to assess performance of the new lung allocation system in Germany based on lung allocation score (LAS). Retrospective analysis of waitlist (WL) outflow, lung transplantation (LTx) activity and 3-month outcomes comparing 1-year pre- and post-LAS introduction on December 10, 2011 was performed. Following LAS introduction, WL registrations remained constant, while WL mortality fell by 23% (p = 0.04). Reductions in WL mortality occurred in patients with cystic fibrosis (CF; −52%), emphysema (chronic obstructive pulmonary disease [COPD]; −49%) and pulmonary hypertension (PH; −67%), but not idiopathic pulmonary fibrosis (IPF; +48%). LTx activity increased by 9% (p = 0.146). Compared to pre-LAS, more patients with IPF (32% vs. 29%) and CF (20% vs. 18%) underwent transplantation and comparatively fewer with COPD (30% vs. 39%). Median LAS among transplant recipients was highest in PH (53) and IPF (49) and lowest in COPD (34). Transplantation under invasive respiratory support increased to 13% (in CF 28%, +85%, p = 0.017). Three-month survival remained unchanged (pre: 96.1% and post: 94.9%, p = 0.94). Following LAS implementation in Germany, reductions in waiting list size and WL mortality were observed. Composition of transplant recipients changed, with fewer COPD and more IPF recipients. Transplantation under invasive respiratory support increased. Reductions in WL mortality were most pronounced among CF and PH patients.

Introduction

Lung transplantation (LTx) has become an established treatment option for patients with various end-stage lung diseases. Currently, approximately 3200 transplants are performed worldwide annually.^[1] Unfortunately, a shortage of donor organs leads to considerable numbers of patients dying on the waiting list before suitable organs become available. Efficient donor organ allocation remains crucial in optimizing donor use, to reduce waitlist (WL) mortality and to improve transplant outcomes. Currently, rules guiding allocation in most countries are based on urgency and transplant benefit, with survival benefit being the accepted primary goal.

Allocation policies are usually based on various factors, including geographical (regional, national, international), accumulated waiting time, audit-derived urgency criteria or individual clinical profile. Existing registry data are often used to assist individual assessment of urgency and transplant benefit in conjunction with clinical judgment. In most regions, national policy constitutes several of these criteria used in combination. Weighing of these factors, however, varies between the different models, with center-based regional distribution common in some European countries (e.g. Belgium, Austria, Italy, Spain and UK), while others place emphasis on waiting period or urgency (e.g. France, Switzerland and the Netherlands).

In May 2005, the United States replaced their waiting time-based system for allocating donor lungs with a system based upon the objectively derived lung allocation score (LAS) for patients of 12 years and older.^[2] The LAS is a numerical value used to assign relative priority in distributing donated lungs. The LAS evaluates several parameters of patient health to direct organ donation toward patients obtaining greatest benefit from LTx. The score is calculated from objective clinical measures of the patient's current health status to estimate survival probability and projected duration of 1-year survival with or without an LTx. LAS values range from 0 to 100, with higher scores indicative of greater predicted survival benefit, directing priority toward these patients.

Data comparing urgency-driven and LAS-based systems are limited.^[3] In December 2011, Germany replaced their previous allocation policy based on both urgency and waiting time with a scheme based on the LAS.

The aim of this study is to describe the performance of this new lung allocation system in Germany in its first use outside of the United States.

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Abstract and Introduction
Methods
Results
Discussion
References

Table 1. Number of lung transplant candidates registered in Germany in the pre-LAS period (December 10, 2010 to December 9, 2011) and the post-LAS period (December 10, 2011 to December 9, 2012).
Factors	Pre-LAS period		Post-LAS period		Post- vs. pre-LAS (%)	p-Value
Total	440		441		–	–
Diagnosis
COPD	173	39.3%	158	35.8%	−8.7	0.092
CF	78	17.7%	77	17.5%	−1.3

Factors	Pre-LAS period		Post-LAS period		Post- vs. pre-LAS (%)		p-Value
Total	440		441		–		–
Diagnosis
COPD	173	39.3%	158	35.8%	−8.7	0.092
CF	78	17.7%	77	17.5%	−1.3
PH	29	6.6%	15	3.4%	−48.3
IPF	118	26.8%	138	31.3%	+16.9
Other	42	9.5%	53	12.0%	+26.2

Factors	Pre-LAS period		Post-LAS period		Post- vs. pre-LAS (%)	p-Value
Total	440		441		–	–
Diagnosis
COPD	173	39.3%	158	35.8%	−8.7	0.092
CF	78	17.7%	77	17.5%	−1.3
PH	29	6.6%	15	3.4%	−48.3
IPF	118	26.8%	138	31.3%	+16.9
Other	42	9.5%	53	12.0%	+26.2

CF, cystic fibrosis; COPD, chronic obstructive pulmonary disease; IPF, idiopathic pulmonary fibrosis; LAS, lung allocation score; PH, pulmonary hypertension.

align="left"> PH 29 6.6% 15 3.4% −48.3 IPF 118 26.8% 138 31.3% +16.9 Other 42 9.5% 53 12.0% +26.2

CF, cystic fibrosis; COPD, chronic obstructive pulmonary disease; IPF, idiopathic pulmonary fibrosis; LAS, lung allocation score; PH, pulmonary hypertension.

Table 2. Mortality on the lung transplant waiting list in Germany in the pre-LAS period (December 10, 2010 to December 9, 2011) and the post-LAS period (December 10, 2011 to December 9, 2012).
Factors	Pre-LAS period		Post-LAS period		Post- vs. pre-LAS (%)	p-Value
Total	95		73		−23.2	0.041
Diagnosis
COPD	33	34.7%	17	23.3%	−48.5	0.031
CF	21	22.1%	10	13.7%	−52.4
PH	6	6.3%	2	2.7%	−66.7
IPF	23	24.2%	34	46.6%	47.8
Other	12	12.6%	10	13.7%	−16.7
ABO blood group
ABO—A	29	30.5%	36	49.3%	24.1	0.057
ABO—AB	2	2.1%	3	4.1%	50.0
ABO—B	7	7.4%	3	4.1%	−57.1
ABO—O	57	60.0%	31	42.5%	−45.6
Age (years)	52 (34–59)		53 (41–59)		–	0.448
Age (years)
<12	0	–	1	1.4%	–	–
12–17	2	2%	1	1.4%	–	–
Height (cm)	170 (162–176)		168 (162–176)		–	0.64
Ventilation status
ECMO-iLA and ventilated	11	11.6%	14	19.2%	27.3	0.014
Ventilated only	5	5.3%	8	11.0%	60.0
ECMO-iLA only	2	2.1%	5	6.9%	150.0
No mechanical ventilation	77	81%	46	62.9%	−40.3
Urgency
HU	22	23.2%	–	–	–	–
U	2	2.0%	–	–	–
T	41	43.2%	–	–	–
NT	30	31.6%	30	41.1%	–
LAS ≥ 50	–	–	19	26.0%	–
LAS = 40–49	–	–	7	9.6%	–
LAS = 30–39	–	–	12	16.4%	–
LAS < 30	–	–	0	0.0%	–
LAS = 0	–	–	5	6.8%	–
Time till death (days)
All	358 (120–994)		229 (23–523)		–	0.005
COPD	409 (193–1060)		504 (244–893)		–	0.72
CF	309 (51–1156)		13 (7–511)		–	0.039
PH	907 (339–1165)		720		–	0.857
IPF	270 (128–713)		75 (13–425)		–	0.018
Other	191 (26–548)		166 (33–451)		–	0.74

CF, cystic fibrosis; COPD, chronic obstructive pulmonary disease; ECMO, extracorporeal membrane oxygenation; HU, high urgent; iLA, interventional lung assist; IPF, idiopathic pulmonary fibrosis; LAS, lung allocation score; NT, nontransplantable; PH, pulmonary hypertension; T, electively transplantable; U, urgent.
Test between periods for proportion NT (p = 0.20) and test between HU versus 50+ (p = 0.67).

Table 3. Number of lung transplant performed in Germany in the pre-LAS period (December 10, 2010 to December 9, 2011) and the post-LAS period (December 10, 2011 to December 9, 2012).
Factors	Pre-LAS period		Post-LAS period		Post- vs. pre-LAS (%)	p-Value
Total	312		340		9.0	0.146
Diagnosis
COPD	123	39.4%	101	29.7%	−17.9	0.033
CF	55	17.6%	68	20.0%	23.6
PH	18	5.8%	16	4.7%	−11.1
IPF	90	28.8%	107	31.5%	18.9
Other	26	8.3%	48	14.1%	84.6
Age (years)	52 (43–58)		52 (40–58)		–	0.63
Age (years)
<12	2	0.6%	7	2%	–	–
12–17	8	2.6%	5	1.5%	–	–
Ventilation status
ECMO-iLA and ventilated	5	1.6%	21	6.2%	320.0	0.017
Ventilated only	8	2.6%	7	2.1%	−12.5
ECMO-iLA only	10	3.2%	16	4.7%	60.0
No mechanical ventilation	289	–	296	–	–
Allocation type
Standard	211	67.6%	223	65.6%	–	0.65
Rescue	101	32.4%	117	34.4%	–	0.65
Diagnosis by allocation type
Standard
COPD	58	27.5%	40	17.9%	–	0.137
CF	37	17.5%	51	22.9%	–
PH	15	7.1%	13	5.8%	–
IPF	77	36.5%	88	39.5%	–
Other	24	11.4%	31	13.9%	–
Rescue
COPD	65	64.4%	61	52.1%	–	0.017
CF	18	17.8%	17	14.5%	–
PH	3	3.0%	3	2.6%	–
IPF	13	12.9%	19	16.2%	–
Other	2	2.0%	17	14.5%	–
Urgency
HU	167	53.5%	–	–	–	<0.0001¹
U	37	11.9%	–	–	–
T	108	34.6%	–	–	–
LAS ≥ 50	–	–	114	33.5%	–
LAS = 40–49	–	–	91	26.8%	–
LAS = 30–39	–	–	126	37.1%	–
LAS < 30	–	–	2	0.6%	–
LAS = 0	–	–	7	2.1%	–
Time until LTx
All	205 (72–628)		124 (37–347)		–	<0.0001

CF, cystic fibrosis; COPD, chronic obstructive pulmonary disease; ECMO, extracorporeal membrane oxygenation; HU, high urgent; iLA, interventional lung assist; IPF, idiopathic pulmonary fibrosis; LAS, lung allocation score; LTx, lung transplantation; PH, pulmonary hypertension; T, electively transplantable; U, urgent.
Continuous factors are presented as median with interquartile ranges.
¹Test between HU/U/T versus 50+/40–49/<40.

Table 4. LAS distribution of all lung transplants performed in Germany the post-LAS period (December 10, 2011 to December 9, 2012).
Cohort	N	%	Median LAS	Median ΔLAS
All	340	–	43 (35–59)	4 (0–16)
Standard	223	65.6	48 (41–67)	9 (1–19)
Rescue	117	34.4	34 (33–39)	1 (0–4)
COPD	101	–	34 (33–39)	1 (0–5)
Standard	40	39.6	39 (34–46)	4 (0–13)
Rescue	61	60.4	33 (32–34)	1 (−1–2)
CF	68	–	48 (39–79)	11 (1–30)
Standard	51	75.0	50 (42–86)	17 (2–33)
Rescue	17	25.0	36 (34–43)	3 (−1–6)
PH	16	–	53 (46–57)	13 (1–19)
Standard	13	81.3	53 (47–64)	13 (1–19)
Rescue	3	18.8	46	14
IPF	107	–	49 (42–65)	6 (0–15)
Standard	88	82.2	50 (44–66)	8 (1–18)
Rescue	19	17.8	41 (36–49)	0 (0–4)
Other	48	–	47 (36–63)	5 (0–23)
Standard	31	64.6	49 (38–67)	8 (0–24)
Rescue	17	35.4	37 (33–56)	1 (0–14)

Median LAS: test between diagnoses (p < 0.0001)/test between diagnoses in Standard (p < 0.0001) and Rescue (p < 0.0001); median ΔLAS: test between diagnoses (p < 0.0001)/test between diagnoses in Standard (p = 0.048) and Rescue (p = 0.157).
CF, cystic fibrosis; COPD, chronic obstructive pulmonary disease; IPF, idiopathic pulmonary fibrosis; LAS, lung allocation score; PH, pulmonary hypertension.

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Introduction of the Lung Allocation Score in Germany

Abstract and Introduction

Abstract

Introduction

Tables

Tables

Tables

Tables

References

Authors and Disclosures

Authors and Disclosures

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