3 Committee considerations

3 Committee considerations

The evidence

3.1

NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 12 sources, which was discussed by the committee. The evidence included 2 meta-analyses, 3 single-arm trials (1 trial included with its sub-study), 1 safety database review, 1 prospective non-randomised comparative study, 2 retrospective comparative studies, 1 prospective registry, 1 sub-set of the prospective registry and 1 case report. The evidence is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.

3.2

The professional experts and the committee considered the key efficacy outcomes to be: clot removal, recovery of cardiac function, 30‑day mortality or survival, symptomatic relief, long-term patient-reported outcome measures, and quality of life.

3.3

The professional experts and the committee considered the key safety outcomes to be: pain, bleeding, damage to vessels and the heart, and worsening cardiac function.

3.4

One commentary from a person who had this procedure was received as part of consultation comments and was discussed by the committee. A submission from a patient organisation representing people who have had this procedure was also discussed.

Committee comments

3.5

The committee noted that more than 1 device is available for this procedure. Devices vary in the size of the introducer and their mechanism and are at different stages of development.

3.6

The committee noted that this is a complex procedure and requires a multidisciplinary team including clinicians with specific experience in managing pulmonary embolism.

ISBN: 978-1-4731-5545-9