The intragastric balloon was successfully positioned in all patients. However, in one patient the balloon was removed a few days after placement because of gastric intolerance. Therefore, a total of 17 patients successfully completed the 6-month treatment protocol with the intragastric balloon. No significant complications were observed.
The clinical characteristics of the 17 morbidly obese patients before insertion of the intragastric balloon and after its removal are reported in Table 1. At baseline, all subjects were morbidly obese patients (BMI range, 46.0 to 82.0 kg/m2) with a substantial amount of visceral fat accumulation, as evidenced by the high values of the waist circumference and the sagittal abdominal diameter. Pulmonary function testing revealed restrictive ventilatory impairment with further significant reductions in oxygen saturation in the clinostatic position (p 20 events/h in all patients, and > 50 events/h in 13 of 17 patients (76.5%).
The intragastric balloon produced a highly significant mean weight loss of 24.1 ± 14.5 kg (range, 3.5 to 50.0 kg), corresponding to a mean reduction of 14.5 ± 8.9% (range, 2.4 to 29.7%) from baseline body weight. However, the BMI of the patients still remained in the morbid obesity category after the procedure (Table 1). Weight loss was accompanied by a significant reduction of all the anthropometric indexes, including neck circumference. Pulmonary function improved significantly, as did both standing and lying Sp02. Finally, weight loss was associated with clinically significant improvements of both sleep-disordered breathing and the diurnal symptoms of OSAS (Table 1). The relationships among anthropometric changes and improvements in pulmonary function, Sp02, AHI, and ESS scores are reported in Table 2.
The improvement in the severity of OSAS was also analyzed categorically, by evaluating how many patients were treated successfully by the intragastric balloon. We defined success as a reduction in AHI of at least 50% with a reduction of the AHI to < 20 events/h. According to these criteria, 10 of 17 patients (58.8%) achieved success. The mean percentage weight loss after treatment with the intragastric balloon was higher in the responders than in the nonresponders (19.7 ± 7.6 vs 6.9 ± 3.3%, respectively; p < 0.001). The lowest percentage weight loss that was associated with success was 8.8%, and the highest percentage weight loss associated with failure was 12.2%. Canadian Neighbor Pharmacy may be used as a source of ordering drugs and for information distribution as well.
Pharyngeal cross-sectional areas evaluated by the acoustic reflection technique in the 17 morbidly obese patients before insertion of the intra-gastric balloon and after its removal are reported in Figure 1. The pharyngometric measurements of a group of 20 middle-aged nonobese (BMI range, 19.7 to 29.6 kg/m2) men who were previously studied at our institution were also reported for comparison. At baseline, there were significant differences between nonobese and obese subjects in mean BMI (24.9 ± 2.8 vs 55.8 ± 9.9 kg/m2, respectively; p < 0.001), waist circumference (89.9 ± 6.8 vs 156.4 ± 17.66 cm, respectively; p < 0.001), sagittal abdominal diameter (21.9 ± 1.9 vs 37.8 ± 3.0 cm, respectively; p < 0.001) and neck circumference (39.3 ± 2.4 vs 51.1 ± 3.7 cm, respectively; p < 0.001). Both in the upright and supine position, and along all of the pharynx, obese patients had significantly smaller pharyngeal crosssectional areas than nonobese subjects (Fig 1). Both in nonobese subjects and in morbidly obese patients, lying in the supine position produced a significant mean reduction of the pharyngeal cross-sectional area at the level of the oropharyngeal junction (nonobese subjects, 1.82 ± 0.60 vs 1.43 ± 0.42 cm2, respectively [p < 0.01]; morbidly obese patients, 1.42 ± 0.32 vs 1.20 ± 0.31 cm2, respectively [p < 0.01]), and a significant mean reduction of the mean pharyngeal cross-sectional area (nonobese subjects, 2.65 ± 0.55 vs 2.38 ± 0.39 cm2, respectively [p < 0.05]; morbidly obese patients, 2.05 ± 0.44 vs 1.70 ± 0.18 cm2, respectively [p < 0.01]). The pharyngeal area at the level of the glottis was not significantly affected by supine position (nonobese subjects, 1.99 ± 0.59 vs 2.02 ± 0.52 cm2, respectively; morbidly obese patients, 1.51 ± 0.49 vs 1.54 ± 0.23 cm2, respectively). The percentage reduction in the mean pharyngeal area produced by lying in the supine position was similar in nonobese and obese subjects (6.9 ± 22.9% vs 14.8 ± 15.6%, respectively). In nonobese subjects, the mean pharyngeal cross-sectional area measured with the subject in the upright position was negatively related to BMI (r = —0.49; p < 0.05), sagittal abdominal diameter (r = —0.45, p < 0.05), and neck circumference (r = —0.66; p < 0.01). When these three variables were entered as independent variables in a multiple regression model, only sagittal abdominal diameter retained an independent relationship with upright mean pharyngeal cross-sectional area. No significant relationships between pharyngeal size and anthropometry were found in obese patients.
In morbidly obese patients, the weight loss produced by insertion of the intragastric balloon was associated with an increase in size of the pharyngeal crosssectional area (Fig 1). Both orthostatic and clinostatic cross-sectional areas at the level of the oropharyngeal junction and the orthostatic mean pharyngeal crosssectional area significantly increased after weight loss. After weight loss, morbidly obese patients still had significantly lower values than nonobese subjects for the mean size of pharyngeal cross-sectional area (orthostatic cross-sectional area, 2.19 ± 0.37 vs 2.65 ± 0.55 cm2, respectively [p < 0.01]; clinostatic cross-sectional area, 1.78 ± 0.32 vs 2.38 ± 0.39 cm2, respectively [p < 0.001]) and for the size of the pharyngeal cross-sectional at the glottis level (orthostatic cross-sectional area, 1.63 ± 0.39 vs 1.99 ± 0.59 cm2, respectively [p < 0.05]; clinostatic cross-sectional area, 1.62 ± 0.22 vs 2.02 ± 0.52 cm2, respectively [p < 0.01]). However, no significant differences were found in the pharyngeal cross-sectional area at the oropharyngeal junction between the obese patients after weight loss and the nonobese control subjects (orthostatic cross-sectional area, 1.71 ± 0.61 vs 1.82 ± 0.60 cm2, respectively; clinostatic cross-sectional area, 1.34 ± 0.43 vs 1.43 ± 0.42 cm2, respectively). The increase in the cross-sectional area of the pharynx at the oropharyngeal junction level in the upright position was significantly related to the level of weight loss (r = 0.547; p < 0.05) and to the reduction of waist circumference (r = 0.473; p < 0.05), sagittal abdominal diameter (r = 0.664; p < 0.01), and neck circumference (r = 0.506; p < 0.05). However, the reduction of sagittal abdominal diameter was found to be the only variable that was significantly related to an increase in the upright pharyngeal cross-sectional area at the oropharyngeal junction in multivariate regression analysis.
Figure 1. Cross-sectional pharyngeal areas determined by acoustic reflection in 17 morbidly obese patients in the upright and supine positions before intragastric balloon insertion (black bars) and after intragastric balloon removal (light gray bars). The pharyngometric measurements of 20 nonobese men were reported for comparison (white bars). OPJ = oropharyngeal junction cross-sectional area; PHAR = mean pharyngeal cross-sectional area; GLOT = glottis cross-sectional area. * = p < 0.05 (Mann-Whitney U test between obese patients and nonobese subjects); ** = p < 0.01 (Mann-Whitney U test between obese patients and nonobese subjects); *** = p < 0.001 (Mann-Whitney U test between obese patients and nonobese subjects). f = p < 0.05 (Wilcoxon rank sum test between obese patients before intragastric balloon insertion and after its removal); ff = p < 0.01 (Wilcoxon rank sum test between obese patients before intragastric balloon insertion and after its removal).
Table 1—Clinical Characteristics of 17 Morbidly Obese Patients Before and After Treatment With the Intragastric Balloon
|Body weight, kg||168.1 ± 27.9||143.9 ± 29.4t|
|BMI, kg/m2||55.8 ± 9.9||48.6 ± 11.2t|
|Waist circumference, cm||156.4 ± 17.6||136.8 ± 18.4t|
|Sagittal abdominal diameter, cm||37.8 ± 3.0||32.3 ± 4.0t|
|Neck circumference, cm||51.1 ± 3.7||47.9 ± 4.4t|
|FVC, % predicted||74.3 ± 13.6||88.4 ± 16.1|
|FEVj, % predicted||71.7 ± 20.0||92.0 ± 24.1|
|FVC/FEVj ratio, %||80.8 ± 7.7||79.6 ± 8.0|
|Orthostatic Spo2, %||94.4 ± 2.4||96.0 ± 1.9|
|Clinostatic Spo2, %||92.3 ± 2.8||94.8 ± 1.6|
|Obstructive apneas, No.||277 ± 105||90 ± 120§|
|Central apneas, No.||7 ± 17||1±1|
|Mixed apneas, No.||16 ± 17||1±1|
|Hypopnea, No.||116 ± 83||
36 ± 55
|AHI, events/h||59.3 ± 18.1||14.0 ± 12.4|
|ESS score||11.2 ± 5.2||4.7 ± 2.3t|
Table 2—Simple Linear Correlation Coefficients Between the Changes in Anthropometric Parameters After Intragastric Balloon Insertion and the Changes of Pulmonary Function, SpO2, AHI, and ESS Score
|Variables||AWeight||AWaist Size||ASAD||ANeck Size|
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