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581
Orlandi et al.
SNOT-20 improvement at 1 year (1.9 to 0.8, p < 0.01) with 91.6% patency
improvements; study did
not reach power calculation
BCD provided improvement in QoL and CT score BCD provided mean
improvements in SNOT-20 at 24-weeks maintained to 52-weeks
improvement in subjective
and objective findings at all time points
TABLE XII-16 Evidence for balloon sinus dilation Study Year LOE Study Design Study Groups Clinical Endpoint Conclusions Bikhazi 2005 Cutler 2006 2013, 2014 2 Individual RCT BCD(n = 50) vs ESS (n = 42); CRS/RARS with minimal maxillary and ethmoid disease only, SNOT-20, 1-year follow up BCD is as effective as ESS in treatment of CRS with maxillary disease with or without anterior ethmoid disease Achar 2004 2012 3 Individual RCT BCD(n = 12) vs ESS (n = Payne 2003 polyp disease excluded
Sinus surgery utilizing BCD had significantly greater
QoL improvements than
medical management alone
improvement in SNOT-20 and RSI at 1 year
BCD yielded improvement in SNOT-20 at all time points and LM at 24-weeks
Both groups with similar
BCD provided significant
BCD provided significant
BCD provided significant
clearance time at 6-, 12- and 24-weeks
SNOT-20, LM scores at 3-6months SNOT-20/RSI at
SNOT-20 at 2-, 8-, 24-, and 52-weeks
SNOT-20, endoscopy, LM scores at 1-, 6-, and 12-months
Chronic sinusitis survey score,
SNOT-20, RSDI at 24-weeks and 52-weeks
1-month, 6-months and 1 year
SNOT-20 at 1-year
SNOT-20 at 1-, 4-, 24-, and 52-weeks LM at 24-weeks
SNOT-20, saccharine
LM scores at 24-weeks Safety, patency,
continued medical management (n = 52),
CRS without nasal polyps (n = 13) CRS or RARS (n = 81),
procedure (n = 146) vs
BCD + / − adjunctive
CRS (n = 122 at 1 year),
CRS (n = 20), limited
CRS (n = 175), polyp
CRS (n = 37), polyp
limited polyp disease included
polyp disease included
12); patients with polyps excluded
Limited polyp disease included
polyp disease excluded
disease included
disease included
Abreu 2007 2014 4 Prospective cohort study
Raghunandhan 2009 2013 4 Prospective cohort study
Karanfilov 1797 Sikand 1798 2013, 2015 4 Prospective cohort study
2016, 2018 4 Prospective cohort study
Gould 1799 2014 4 Prospective cohort study
Brodner 2008 2013 4 Prospective cohort study
Albritton 1796 2012 4 Prospective cohort study
Stolovitzky 2002
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