Minimal important difference of target lobar volume reduction after endobronchial valve treatment for emphysema

Welling, Jorrit B A; Hartman, Jorine E.; Rikxoort, Eva M. van; Hacken, Nick H. T. ten; Kerstjens, Huib A. M.; Klooster, Karin; Slebos, Dirk‐Jan

doi:10.1111/resp.13178

Cited by 36 publications

(27 citation statements)

References 31 publications

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“…This is an important finding since the Chartis measurement was not yet validated under general anesthesia. The absence of collateral ventilation in combination with successful EBV placement, resulting in sufficient TLVR, is the driver for treatment success as TLVR is a predictor for clinically meaningful change after treatment [16,17].…”

Section: Discussionmentioning

confidence: 99%

Chartis Measurement of Collateral Ventilation: Conscious Sedation versus General Anesthesia – A Retrospective Comparison

Welling

Hartman

Hacken³

et al. 2018

Respiration

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Background: Absence of interlobar collateral ventilation using the Chartis measurement is the key predictor for successful endobronchial valve treatment in severe emphysema. Chartis was originally validated in spontaneous breathing patients under conscious sedation (CS); however, this can be challenging due to cough, mucus secretion, mucosal swelling, and bronchoconstriction. Performing Chartis under general anesthesia (GA) avoids these problems and may result in an easier procedure with a higher success rate. However, using Chartis under GA with positive pressure ventilation has not been validated. Objectives: In this study we investigated the impact of anesthesia technique, CS versus GA, on the feasibility and outcomes of Chartis measurement. Methods: We retrospectively analyzed all Chartis measurements performed at our hospital from October 2010 until December 2017. Results: We analyzed 250 emphysema patients (median forced expiratory volume in 1 s 26%, range 12–52% predicted). In 121 patients (48%) the measurement was performed using CS, in 124 (50%) using GA, and in 5 (2%) both anesthesia techniques were used. In total, 746 Chartis readings were analyzed (432 CS, 277 GA, and 37 combination). Testing under CS took significantly longer than GA (median 19 min [range 5—65] vs. 11 min [3–35], p < 0.001) and required more measurements (3 [1–13] vs. 2 [1–6], p < 0.001). There was no significant difference in target lobe volume reduction after treatment (–1,123 mL [–3,604 to 332] in CS vs. –1,251 mL [–3,333 to –1] in GA, p = 0.35). Conclusions: In conclusion, Chartis measurement under CS took significantly longer and required more measurements than under GA, without a difference in treatment outcome. We recommend a prospective trial comparing both techniques within the same patients to validate this approach.

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Section: Discussionmentioning

confidence: 99%

Chartis Measurement of Collateral Ventilation: Conscious Sedation versus General Anesthesia – A Retrospective Comparison

Welling

Hartman

Hacken³

et al. 2018

Respiration

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“…As this randomized controlled trial was started in 2013, TLVR with a minimum clinically important difference defined as a 350-mL reduction was chosen based on the results of VENT [12] and European VENT [11]. However, more recent experience suggests that a higher TLVR is necessary to achieve a clinically relevant benefit [24, 25]. Only 1 female was included, but this seems to reflect the much higher ratio of males with emphysema in China [2].…”

Section: Discussionmentioning

confidence: 99%

The REACH Trial: A Randomized Controlled Trial Assessing the Safety and Effectiveness of the Spiration® Valve System in the Treatment of Severe Emphysema

Wang

et al. 2018

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Background: Chronic obstructive pulmonary disease (COPD) has become a leading cause of morbidity and mortality in China, with tobacco smoke, air pollution, and occupational biohazards being the major risk factors. Objectives: The REACH trial is a multicenter, prospective, randomized controlled trial undertaken in China to assess the safety and effectiveness of the Spiration® Valve System (SVS) compared to standard medical care in COPD patients with severe emphysema. Methods: Patients with severe airflow obstruction, hyperinflation, and severe dyspnea with interlobar fissure integrity were evaluated for enrollment. A total of 107 subjects were randomized in a 2: 1 allocation ratio to either the treatment group (SVS valves and medical management) or the control group (medical management alone). Results: The 3-month primary endpoint showed statistically significant improvement in forced expiratory volume in 1 s in the treatment group compared to the control group (0.104 ± 0.18 vs. 0.003 ± 0.15 L, p = 0.001), with the difference being durable through 6 months. Statistically significant target lobe volume reduction was achieved at 3 months (mean change 684.4 ± 686.7 mL) and through 6 months (757.0 ± 665.3 mL). Exercise function and quality of life measures improved in the treatment group, but showed a deterioration in the control group. The serious adverse event (SAE) rate was 33% in the treatment group and 24.2% in the control group. The predominance of SAEs were acute exacerbations of COPD in both groups. There was 1 death in the control group and no deaths in the treatment group. Conclusion: The SVS represents a novel approach for the treatment of severe emphysema with a clinically acceptable risk-benefit profile.

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“…Welling et al . performed a retrospective analysis of target lobar volume reduction in over 300 patients, showing that the minimally important degree of volume reduction required to predict clinically important improvement is just over 560 mL, higher than expected from prior studies . These findings will impact future clinical trials and clinical practice .…”

Section: Copdmentioning

confidence: 91%

Contemporary Concise Review 2018: Asthma and chronic obstructive pulmonary disease

Upham

2019

Respirology

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Minimal important difference of target lobar volume reduction after endobronchial valve treatment for emphysema

Cited by 36 publications

References 31 publications

Chartis Measurement of Collateral Ventilation: Conscious Sedation versus General Anesthesia – A Retrospective Comparison

Chartis Measurement of Collateral Ventilation: Conscious Sedation versus General Anesthesia – A Retrospective Comparison

The REACH Trial: A Randomized Controlled Trial Assessing the Safety and Effectiveness of the Spiration® Valve System in the Treatment of Severe Emphysema

Contemporary Concise Review 2018: Asthma and chronic obstructive pulmonary disease

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