PMID- 22927751
OWN - NLM
STAT- MEDLINE
DCOM- 20130116
LR  - 20211021
IS  - 1178-2005 (Electronic)
IS  - 1176-9106 (Print)
IS  - 1176-9106 (Linking)
VI  - 7
DP  - 2012
TI  - Characterization of outcomes 1 year after endoscopic thermal vapor ablation for 
      patients with heterogeneous emphysema.
PG  - 397-405
LID - 10.2147/COPD.S31082 [doi]
AB  - INTRODUCTION: Endoscopic lung volume reduction has been developed as a 
      therapeutic option for advanced emphysema. Six-month results following treatment 
      with endoscopic thermal vapor ablation (InterVapor; Uptake Medical, Tustin, CA) 
      were described previously, and here we report observations from the 12-month 
      assessment. METHODS: Two multicenter, international, single-arm trials of 
      InterVapor (unilateral upper lobe treatment) in patients with upper lobe 
      predominant emphysema were conducted. INCLUSION CRITERIA: forced expiratory 
      volume in 1 second (FEV(1)) 15%-45% predicted, residual volume > 150%, total lung 
      capacity > 100%, 6-minute walk distance (6MWD) > 140 m, and diffusing capacity 
      for carbon monoxide > 20% predicted. Efficacy endpoints: spirometry, body 
      plethysmography, lung volumes by high-resolution computed tomography, St George's 
      Respiratory Questionnaire, modified Medical Research Council dyspnea scale, and 
      6MWD. All adverse events were collected and independently adjudicated. RESULTS: 
      Forty four patients were treated at a mean (standard deviation) age of 63 (5.6) 
      years, FEV(1) 0.86 mL (0.25 mL) (n = 22 men and 22 women). Mean (standard 
      deviation) changes from baseline at 12 months were: FEV(1) 86.2 mL (173.8 mL), St 
      George's Respiratory Questionnaire -11.0 (14.0) units, treated lobar volume from 
      high-resolution computed tomography -751.8 mL (653.9 mL), residual volume -302.8 
      mL (775.6 mL), 6MWD 18.5 m (63.7 m), and modified Medical Research Council 
      dyspnea scale score -0.83 (0.97) (P < 0.05 for all except 6MWD). Improvements 
      were numerically larger at 6 versus 12 months. GOLD stage III and IV patients had 
      similar outcomes at 6 months; however, improvements relative to baseline were 
      numerically higher in GOLD stage IV patients. Larger improvements were observed 
      in patients with higher heterogeneity. In total, 39 serious adverse events were 
      reported in 23 patients with 10 events in 8 patients between 6 and 12 months. 
      CONCLUSION: Unilateral lobar InterVapor treatment of heterogeneous emphysema 
      improved lung function and health outcomes 1 year following treatment. The 
      magnitude of improvement was larger at 6 months compared to 12 months. 
      Improvements relative to baseline continue to be exhibited at 12 months despite 
      the expected disease related decline over time.
FAU - Herth, Felix J F
AU  - Herth FJ
AD  - Department of Pneumology and Critical Care Medicine, Thoraxklinik Heidelberg, 
      German Center for Lung Research, University of Heidelberg, Heidelberg, Germany. 
      felix.herth@thoraxklinik-heidelberg.de
FAU - Ernst, Armin
AU  - Ernst A
FAU - Baker, Kimberly M
AU  - Baker KM
FAU - Egan, Jim J
AU  - Egan JJ
FAU - Gotfried, Mark H
AU  - Gotfried MH
FAU - Hopkins, Peter
AU  - Hopkins P
FAU - Stanzel, Franz
AU  - Stanzel F
FAU - Valipour, Arschang
AU  - Valipour A
FAU - Wagner, Manfred
AU  - Wagner M
FAU - Witt, Christian
AU  - Witt C
FAU - Kesten, Steven
AU  - Kesten S
FAU - Snell, Gregory
AU  - Snell G
LA  - eng
SI  - ClinicalTrials.gov/NCT01041586
SI  - ClinicalTrials.gov/NCT01102712
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20120718
PL  - New Zealand
TA  - Int J Chron Obstruct Pulmon Dis
JT  - International journal of chronic obstructive pulmonary disease
JID - 101273481
SB  - IM
MH  - *Ablation Techniques/adverse effects
MH  - Aged
MH  - Australia
MH  - *Bronchoscopy/adverse effects
MH  - Europe
MH  - Exercise Test
MH  - Exercise Tolerance
MH  - Female
MH  - Forced Expiratory Volume
MH  - Humans
MH  - Lung/physiopathology/*surgery
MH  - Lung Volume Measurements
MH  - Male
MH  - Middle Aged
MH  - Plethysmography, Whole Body
MH  - Pneumonectomy/adverse effects/*methods
MH  - Pulmonary Diffusing Capacity
MH  - Pulmonary Emphysema/diagnosis/physiopathology/*therapy
MH  - Recovery of Function
MH  - Residual Volume
MH  - Severity of Illness Index
MH  - Spirometry
MH  - Surveys and Questionnaires
MH  - Time Factors
MH  - Tomography, X-Ray Computed
MH  - Total Lung Capacity
MH  - Treatment Outcome
MH  - United States
MH  - Walking
PMC - PMC3422124
OTO - NOTNLM
OT  - bronchoscopy
OT  - emphysema
OT  - lung volume reduction
OT  - thermal energy
EDAT- 2012/08/29 06:00
MHDA- 2013/01/17 06:00
PMCR- 2012/07/18
CRDT- 2012/08/29 06:00
PHST- 2012/08/29 06:00 [entrez]
PHST- 2012/08/29 06:00 [pubmed]
PHST- 2013/01/17 06:00 [medline]
PHST- 2012/07/18 00:00 [pmc-release]
AID - copd-7-397 [pii]
AID - 10.2147/COPD.S31082 [doi]
PST - ppublish
SO  - Int J Chron Obstruct Pulmon Dis. 2012;7:397-405. doi: 10.2147/COPD.S31082. Epub 
      2012 Jul 18.