Clinical and technical evidence

A literature search was carried out for this briefing in line with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.

Published evidence

This briefing summarises 2 retrospective analyses and 1 randomised controlled trial that included 323 patients.

Table 1 summarises the clinical evidence as well as its strengths and limitations.

Overall assessment of the evidence

Two studies (Schuhmann et al. 2015, de Oliveira et al. 2016) assessed the accuracy of selecting patients for lung volume reduction surgery using fissure integrity (FI) values obtained using VIDAvision QCT. It is unclear how patients were selected for inclusion into the studies. Analyses were retrospective and study authors may have been aware of the patient outcome before analysis. One randomised controlled trial (RCT; Gompelmann et al. 2016) showed that patients with similar FI at baseline had different FEV1 scores at 12-month follow-up. It also showed that FI could be used to select patients for ELVR treatments. This analysis was based on post hoc analyses from a subset of patients in an RCT. Prospective studies comparing subject selection and ELVR outcome using QCT with current standard care are needed to confirm equivalence between the 2 methods.

Table 1 Summary of selected studies

Schuhmann et al (2015)

Study size, design and location

N=146

Retrospective analysis of people with COPD (Global Initiative for Chronic Obstructive Lung Disease III or IV with residual volume) who had ELVR.

Germany.

Intervention and comparator(s)

Intervention: QCT using VIDAvision software.

Key outcomes

82/146 (56%) of patients had disease that responded to ELVR. A subset analysis of 33 patients found there was no difference between Chartis and VIDAvision. FI QCT had high accuracy (75.8% both groups) of selecting people for endobronchial valve LVR between.

Strengths and limitations

Response to LVR may be because of positional errors and variations in anatomy rather than diagnostic approach. The CT protocol used for the scans was not scanner specific and not ideal for quantitative imaging evaluation.

de Oliveira et al. 2016

Study size, design and location

N=108 (Only 38 patients with baseline and follow-up scans available for full evaluation).

Single-centre retrospective study of patients with emphysema (GOLD stage III or IV) having bronchoscopic ELVR between June 2008 and May 2014.

Brazil.

Intervention and comparator(s)

Intervention: QCT using VIDAvision.

Key outcomes

Mean and median ELVR was 1,223 ml (SD=907) and 663 ml in lungs with FI ≥75% (n=31).

The accuracy of FI ≥75% to predict lung volume reduction ≥350 ml was 87.2%.

PPV of FI values to predict LVR ≥350 ml:

  • FI≥75%, PPV=83.9%

  • FI=75 to 90%, PPV=70%

  • FI>90%, PPV=90.5%.

Median interval between baseline and follow-up CT was 201 days.

Strengths and limitations

Retrospective study. Single-site study so does not take into account inter-rater variability. ELVR was not measured at the same time points for all patients. High loss to follow-up for repeat scan.

Gompelmann et al. 2016

N=69

Multinational (Australia, Austria, Germany, Ireland, New Zealand and UK) RCT for patients with upper-lobe-predominant heterogeneous emphysema (>15% difference in lung density between targeted upper lobe segment and lower lobe) assigned on 2:1 ratio, with 12-month follow-up.

Intervention and comparator(s)

Intervention: BTVA; n=45. All patients had QCT using VIDAvision software at baseline and 12 months' follow-up. FI<90% used as threshold to define incomplete fissures and these patients assumed to have CV.

Comparator: Medical management (n=24).

Key outcomes

78% and 79% of patients in the intervention and control group had CV (FI <90%).

At 12 months' FEV1 in the intervention group improved by 9.2% but there was a decrease of 5.4% in the control group (mean difference 14.6%, p=0.014). HRQoL as measured by the St George's Respiratory Questionnaire, improved by 8.4 points in the intervention group relative to the controls (p=0.071).

Strengths and limitations

Post hoc analysis of RCT data not part of initial trial analysis plan.

Abbreviations: BTVA, bronchoscopic thermal vapour ablation; CV, collateral ventilation; ELVR, endobronchial lung volume reduction; FEV1, forced expiratory volume in 1 second; FI, fissure integrity; HRQoL, health-related quality of life; LVR, lung volume reduction; PPV, positive predictive value, QCT, quantitative computer tomography; RCT, randomised controlled trial.

Recent and ongoing studies

No ongoing or in-development trials were identified for the use of VIDAvision in determining selection for ELVR surgery.