Interventional procedures consultation document - living donor lung transplantation for end-stage lung disease
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional Procedure Consultation Document
Living donor lung transplantation for end-stage lung disease
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The National Institute for Health and Clinical Excellence is examining living donor lung transplantation for end-stage lung disease and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about living donor lung transplantation for end-stage lung disease.
Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation. The process that the Institute will follow after the consultation period ends is as follows.
For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual). Closing date for comments: 31 January 2006 |
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Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation. |
| 1 | Provisional recommendations |
| 1.1 |
Current evidence on the safety and efficacy of living donor lung transplantation for end-stage lung disease appears adequate to support the use of this procedure in selected patients who would otherwise die. |
| 1.2 |
Limited evidence suggests that this procedure confers a significant risk of morbidity for donors. Therefore clinicians wishing to undertake this procedure should take the following actions.
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| 1.3 | These procedures should be performed in specialist centres in the context of a multidisciplinary team. Donor lungs should be harvested by specialist thoracic surgeons. |
| 1.4 |
Clinicians should enter all donors and recipients into the UK National Audit of Intrathoracic Transplantation (www.rcseng.ac.uk/research/ceu/projects/proj_intrathoracic.html). |
| 2 | The procedure |
| 2.1 | Indications |
| 2.1.1 | Lung transplants are performed in patients with non-malignant pulmonary disease that is unresponsive or minimally responsive to treatment and who have a life expectancy of less than a year. The underlying causes include cystic fibrosis, severe pulmonary fibrosis, pulmonary hypertension and obliterative bronchiolitis. |
| 2.1.2 | The majority of live donor lung recipients are patients with cystic fibrosis. The majority of lung donors are first-degree relatives who are compatible in terms of size and ABO blood group. |
| 2.1.3 |
Living donation is an alternative to cadaveric organ donation. Living donation is an option for patients for whom cadaveric transplantation is unsuitable, or who have deteriorated clinically to the point of transplant ineligibility while waiting for a cadaveric donor. Living donation may also be an option for critically ill children, as there is a particular shortage of suitable cadaveric donors for this age group. |
| 2.2 | Outline of the procedure |
| 2.2.1 | Living donor lung transplantation requires three operations: two donor lobectomies (one donor providing the right lower lobe and another the left), and the recipient bilateral pneumonectomy and lung implant. |
| 2.2.2 |
The recipient operation is performed through a transverse thoracosternotomy (clamshell) incision. Procedures are performed on cardiopulmonary bypass. Once the pneumonectomies have been completed the harvested lobes are implanted sequentially. When the second lobe has been implanted both lungs are inflated and the patient is weaned from cardiopulmonary bypass. Transoesophageal echocardiography and bronchoscopy are then performed to check for complications such as air leaks. |
| 2.3 | Efficacy |
| 2.3.1 | In a study of 123 adult and paediatric patients who had undergone living lung transplantation, 1-, 3- and 5-year survival was 70%, 54% and 45% respectively. Infection was the main cause of death (33/63; 52%), followed by obliterative bronchiolitis (8/63; 13%). |
| 2.3.2 | In a non-randomised study from the same centre outcomes were compared between living (n = 59) and cadaveric (n = 43) lung recipients who had survived more than 3 months after transplant. The study found no significant differences between the groups with respect to survival; 1-, 3- and 5-year survival was 83%, 64% and 62% in the living lung group compared to 83%, 81% and 75% in the cadaveric lung group. A true comparative analysis is difficult, however, because those receiving living lung transplants often have poorer outcomes by nature of eligibility criteria (for example, underlying lung disease and preoperative severity of illness). |
| 2.3.3 |
Where pulmonary function was measured in the studies it was reported that patients who had undergone living lung transplantation had improved function compared to preoperative values. For more details, refer to the sources of evidence (see Appendix). |
| 2.3.4 |
Some Specialist Advisors expressed uncertainties about the long-term outcomes of recipients following living lung transplantation and the incidence of obliterative broncholitis compared to those undergoing cadaveric lung transplantation. The Specialist Advisors also stated that donors were likely to experience loss of lung function following lobectomy. |
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| 2.4 | Safety |
| 2.4.1 |
There was limited information reported on the complications in recipients following living lung transplantation. In the studies that included both adult and paediatric patients, the incidence of acute rejection ranged from 0.8 to 1.5 episodes per patient. In a small study of 30 patients, complications following living lung transplantation included pulmonary oedema in 20% (6/30), haemorrhage necessitating rethoracotomy in 7% (2/30) and cardiac tamponade in 7% (2/30). Tracheostomy was required in 15 patients (50%), and reintubation in seven patients (23%). |
| 2.4.2 | There were no reports of donor mortality following lobectomy. In one study it was reported that 20% (50/283) of donors had one or more perioperative complications following lobectomy. The most common complication was the need for a thoracostomy tube in 30% (15/50), either for persistent drainage or for air leaks. The most significant complication was pulmonary artery thrombosis, which occurred in two patients (1%). Eight patients (3%) also required reoperation because of bleeding (1.2%), bronchopulmonary fistula (0.4%), unresponsive pericarditis (0.4%), loculated pleural effusion (0.4%), a sterile empyema (0.4%) and a retained sponge (0.4%). In a study following 253 donor lobectomies it was reported that donors who could be contacted at 1 and 2 years had reduced pulmonary function compared to preoperative values. For more details, refer to the sources of evidence (see Appendix). |
| 2.4.3 | The Specialist Advisors considered the main complications in recipients to be rejection and hyperexpansion of the transplants leading to significant lung injury and subsequent failure. With respect to donors, the Specialist Advisors listed potential complications following donor lobectomy as prolonged air leak, bleeding, pleural sepsis and pulmonary embolism. |
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| 2.5 | Other comments |
| 2.5.1 | It was noted that this procedure is currently funded by the National Specialist Commissioning Advisory Group in specified centres. |
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
January 2006
| Appendix: | Sources of evidence |
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The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.
Available from: www.nice.org.uk/ip292overview | |
This page was last updated: 04 February 2011