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Assessment of the effect of bariatric surgery on severe obstructive sleep apnea patients not tolerating CPAP therapy
Egyptian Journal of Chest Diseases and Tuberculosis (2016) xxx, xxx–xxx
H O S T E D BY
The Egyptian Society of Chest Diseases and Tuberculosis
Egyptian Journal of Chest Diseases and Tuberculosis www.elsevier.com/locate/ejcdt www.sciencedirect.com
ORIGINAL ARTICLE
Assessment of the effect of bariatric surgery on severe obstructive sleep apnea patients not tolerating CPAP therapy H. Shaarawy a,*, Abdelrahman Sarhan b, A. EL Hawary c a
Chest Diseases Department, Faculty of Medicine, Alex. University, Egypt General Surgery Department, Faculty of Medicine, Zagazig University, Egypt c Chest Diseases Department, Faculty of Medicine, Zagazig University, Egypt b
Received 11 December 2015; accepted 21 April 2016
KEYWORDS OSA; Sleeve gastrectomy; CPAP
Abstract Obstructive sleep apnea (OSA) is increasingly prevalent worldwide and is associated with morbidity and mortality, the main line of treatment is CPAP but the compliance is doubtful, as obesity is highly linked to OSA weight loss can help in treatment. The aim of the present study: was to assess the effect of bariatric surgery on severe obstructive sleep apnea patients not tolerating CPAP therapy. Patients and methods: the study was done on 22 patients documented to have morbid obesity (BMI > 40) and severe OSA with Apnea Hypopnea Index (AHI) >30/h and not tolerating CPAP therapy, patients were offered sleeve gastrectomy then were followed up for 12 months before another polysomnography was done to assess the presence of OSA and need for CPAP. Results: 22 patients completed the study. The mean age of the patients was 37.2 ± 17.3 years, 13 males and 9 females. After sleeve gastrectomy and follow up for 12 months the body weight decreased from 135.6 ± 17.8 to 101.3 ± 7.6 kg m (p = 0.001), BMI dropped from 48.2 ± 7.3 to 35.9 ± 4.8 kg m/m2 (p = 0.001), mean AHI decreased from 55.8 ± 8.3 to 12.8 ± 11.3 attacks/hour of sleep (p = 0.001) and CPAP pressure needed to control OSA was decreased from 13.2 ± 2.3 to 8.2 ± 3.9 cm H2O (p = 0.001). Conclusion: sleeve gastrectomy can be an alternate option of treatment for severe OSA patients who are not tolerating CPAP and surgery may cure the disease or at least improve compliance to CPAP by decreasing the needed pressure to control OSA. Ó 2016 The Egyptian Society of Chest Diseases and Tuberculosis. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-ncnd/4.0/).
Introduction
* Corresponding author. Peer review under responsibility of The Egyptian Society of Chest Diseases and Tuberculosis.
OSA is increasingly prevalent, in both adults and children, in modern society. The estimated prevalence has been 2% for women and 4% for men. More recent research indicates a prevalence of 4% for women and 9% for men. Data from the Wisconsin Cohort Study indicate that the prevalence of
http://dx.doi.org/10.1016/j.ejcdt.2016.04.007 0422-7638 Ó 2016 The Egyptian Society of Chest Diseases and Tuberculosis. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Please cite this article in press as: H. Shaarawy et al., Assessment of the effect of bariatric surgery on severe obstructive sleep apnea patients not tolerating CPAP therapy, Egypt. J. Chest Dis. Tuberc. (2016), http://dx.doi.org/10.1016/j.ejcdt.2016.04.007
2 OSA in people aged 30–60 years is 9–24% for men and 4–9% for women [1,2]. A recent study examining the association between OSA and mortality using portable sleep studies on more than 77,000 patients found that OSA was associated with all-cause mortality in patients younger than 50 years of age. While this is a general conclusion from the study, other variables played a substantial role in mediating this relationship. These data are consistent with earlier data showing that the negative impact of OSA on health is more profound in younger patients [3–6]. Currently, the treatment of choice for OSA is nasal continuous positive airway pressure (CPAP) [7]. Despite the documented efficacy of CPAP, it has been estimated that more than 50% of those patients started on CPAP will not be using it 1 year later [8]. Because obesity is a major predictive factor for OSA, weight reduction reduces the risk of OSA. The best data suggest that a 10% reduction in weight leads to a 26% reduction in the respiratory disturbance index (RDI). Benefits of weight reduction in patients with sleep disordered breathing SDB include the following: decreased RDI, lowered blood pressure, improved pulmonary function and arterial blood gas values, improved sleep structure and snoring, possible reduction in optimum CPAP pressure required [9–11]. In this respect bariatric surgery as therapy for OSA has been investigated in several nonrandomized, uncontrolled studies, with most showing a decrease in the AHI with weight loss. The 2006 practice parameter on medical therapies for OSAHS lists bariatric surgery as an option for OSA, although with limited evidence [12]. In a position paper on the treatment of OSA, the American Academy of Sleep Medicine (AASM) stated that bariatric surgery should be considered as an adjunct to less invasive and rapidly active first-line therapies such as positive airway pressure for patients who have OSA and meet the currently published guidelines for bariatric surgery (Consensus). The remission rate for OSA two years after bariatric surgery, related to the amount of weight lost, is 40%, emphasizing the need for ongoing clinical follow-up of these patients [13]. Aim of the work The aim of the present study is to assess the effect of bariatric surgery on severe obstructive sleep apnea patients not tolerating the CPAP therapy. Patients The study is a prospective single center observational study; it was done in the pulmonary rehabilitation center in association with the surgical department in Al-Amiri hospital, Ministry of Health, State of Kuwait in the period between June 2013 and July 2015. Patients were selected from those following up in sleep disorders clinic of the pulmonary rehabilitation center according to the following criteria: 1. Age: 18–55 years. 2. Patients proved to have severe obstructive sleep apnea (OSA) documented with polysomnography with Apnea Hypopnea Index (AHI) more than 30/hour of sleep.
H. Shaarawy et al. 3. Body mass index more than 40 kg/m2. 4. Attempt of losing weight was tried 2 times or more but failed. 5. Patients not tolerating CPAP therapy with documented compliance less than 4 h/night. 6. Patients must have no contraindication for surgery due to other co-morbidities. 7. Written consent was taken from all patients before indulging in the study. Methods All patients were subjected to the following: 1. 2. 3. 4. 5. 6. 7.
8. 9. 10.
11. 12.
History taking. Complete physical examination. Epworth Sleepiness Scale [14]. Body mass index derived from the weight and height formula (BMI = Wt in kg m/length in m2) [15]. Neck circumference. Pulmonary function testing. Arterial blood gases to make sure that the patient is not having obesity hypoventilation syndrome or any chronic respiratory disease. Chest X-ray. ECG. Pre-operative full night polysomnography using Alice 5 (Respironics) device including the following channels: electroencephalogram, electrooculogram, electromyogram, measurement of thoracic and abdominal movements, air flow detection, detection of intensity of snoring with pressure sensor, pulse oximetry to detect oxygen saturation and heart rate, position detection. According to polysomnography AHI was graded as mild if between 5 and 14 attacks/hour of sleep, moderate if between 15 and 30 attacks/hour of sleep, and severe if above 30/hour of sleep and the patient was included in the study only if having severe OSA. Pre-operative surgical assessment was done to assess for fitness for surgery. After taking written informed consent the patient was referred to surgical department for sleeve gastrectomy (the type of bariatric surgery used in the present study), it is done by removing part of the stomach along the greater curvature to leave only 25% of the original size of the stomach in the form of tube-like structure with capacity about 150 ml, procedure is simple and done through laparoscopy without affecting the absorption of nutrients and vitamins from the intestine [16]. All patients will receive prophylactic anticoagulant dose of unfractionated heparin 5000 IU subcutaneously immediately preoperatively and will also be treated with sequential compression devices. Patients will receive anticoagulants postoperatively for two weeks. CPAP was used in the immediate post-operative period and was used thereafter during sleep in the day and night until discharge from hospital, morphine-like drugs or medications that can affect the respiratory center was avoided during the post-operative period.
Please cite this article in press as: H. Shaarawy et al., Assessment of the effect of bariatric surgery on severe obstructive sleep apnea patients not tolerating CPAP therapy, Egypt. J. Chest Dis. Tuberc. (2016), http://dx.doi.org/10.1016/j.ejcdt.2016.04.007
Assessment of the effect of bariatric surgery on severe obstructive sleep apnea patients 13. After operation patients were followed up in the outpatient clinic for any complication of surgery and for the degree of weight loss. 14. After 12 months of follow up patients were assessed again for: Second time polysomnography was done for new assessment of the degree of OSA and for titration of CPAP pressure again if needed. Degree of weight loss. Body Mass Index. Pulmonary function testing. Epworth Sleepiness Scale.
Statistical analysis All statistical analyses were conducted using the software package SPSS 20.0 for WindowsÒ (SPSS Inc., Chicago, IL, USA). Data are presented as frequencies for categorical variables, and by mean ± standard deviation for numerical variables. Patients’ data were compared before and after surgery using dependent T-test, p values less than 0.05 were considered significant. Results The study was started with 30 patients having severe OSA and not tolerating the CPAP therapy, all patients offered the surgical options, 27 patients accepted and three patients refused the surgical option and was removed from the study, all the 27 patients had undergone the surgery without complications but during the period of follow up 5 patients were lost and did not continue the study. So the study was completed with 22 patients who completed the period of follow up for 12 months. Baseline epidemiologic and anthropometric data of the 22 patients who completed the study are presented in Table 1. From Table 1: the mean age of the patients was 37.2 ± 17.3 years, with 13 male and 9 female patients, the mean neck circumference of the patients was 38.2 ± 3.6 cm, baseline body weight was 135.6 ± 17.8 kg m, mean BMI was
48.2 ± 7.3 kg m/m2 denoting that all patients were in the range of morbid obesity, the mean ESS of the patients was 16.8 ± 6.8. Lastly pulmonary functions (PFT) of the studied group indicated mild restrictive pattern which is mostly due to obesity as chronic respiratory illness was excluded. From Table 2 the TST of the studied patient was 358.1 ± 3.5 min with a sleep efficiency of 69.4 ± 3.25%, the percentage of non REM sleep from the TST was 75.3 ± 6.8%, while the percentage of REM sleep from the TST was 20.4 ± 2.9%, the mean arousal index during sleep was markedly increased denoting disturbed sleep in these patients (40.6 ± 7.9/h) which can affect the quality of life, the total AHI during sleep was 55.8 ± 8.3/h which denotes that all patients had severe degree of OSA, the lowest oxygen saturation reached during sleep was 67.2 ± 11.3%, mean ODI4% was 52.6 ± 6.5/hour of sleep, the mean CPAP pressure titrated for the studied patients was 13.2 ± 2.3 cm H2O. After surgery patients were followed up for 12 months for the degree of weight loss and any possible complication of surgery or recurrence of symptoms of OSA, 2 patients had complete remission of OSA with the AHI dropping below 5 attacks/hour of sleep while 20 patient still had OSA but to a lesser degree than before surgery. A comparison of anthropometric and polysomnography data before and after surgery is presented in Table 3. Table 3 shows a significant decrease in all anthropometric data of the patients, mean neck circumference dropped from 38.2 ± 3.6 to 32.2 ± 4.6 cm (p = 0.001), mean body weight dropped from 135.6 ± 17.8 to 101.3 ± 7.6 kg m (p = 0.001), mean BMI dropped from 48.2 ± 7.3 to 35.9 ± 4.8 kg m/m2 (p = 0.001), consequently this drop was reflected on the ESS which decreased from 16.8 ± 6.8 to 10.2 ± 3.5 (p = 0.001) and on the pulmonary function parameters which improved as follows: FEV1% pred. was increased from 70.3 ± 3.64 to 71.5 ± 3.8 (p = 0.04) and FVC% pred. was increased from 69.6 ± 6.5 to 74.2 ± 3.4 (p = 0.02). As regards the polysomnography data sleep efficiency was increased from 69.4 ± 3.25 to 75.4 ± 6.25 (p = 0.04), mean lowest Sao2 during sleep was increased from 67.2 ± 11.3 to 92.2 ± 5.3% (p = 0.001), mean AHI was decreased from 55.8 ± 8.3 to 12.8 ± 11.3 attacks/hour of sleep (p = 0.001), mean arousal index was decreased from 40.6 ± 7.9 to 13.6 ± 8.9/hour of sleep (p = 0.001), mean oxygen desaturation index 4% was decreased from 52.6 ± 6.5 to 10.6 ± 6.5/hour of sleep
Table 1 Baseline epidemiologic and anthropometric data of patients. Character
Mean ± SD
No. of patients Age in years Gender: male/female ratio Neck circumference in Cm Baseline body weight in kg m Body mass index (kg/m2) Epworth Sleepiness Scale (ESS)
22 37.2 ± 17.3 13/9 38.2 ± 3.6 135.6 ± 17.8 48.2 ± 7.3 16.8 ± 6.8
PFT FEV1% pred. FVC% pred. FEV1/FVC ratio
70.3 ± 3.64 69.6 ± 6.5 83.4 ± 2.3
FEV1: forced expiratory volume in the first second, FVC: forced vital capacity.
Table 2 Baseline polysomnography data of the patients before surgery. Character
Mean ± SD
Total sleep time (TST) in min. Sleep efficiency Non REM sleep time as % from TST REM sleep time as % from TST Arousal index/hour AHI/hour Lowest Sao2 during sleep Oxygen desaturation index 4% CPAP pressure after titration
358.1 ± 3.5 69.4 ± 3.25 75.3 ± 6.8 20.4 ± 2.9 40.6 ± 7.9 55.8 ± 8.3 67.2 ± 11.3 52.6 ± 6.5 13.2 ± 2.3 cm H2O
REM: Rapid Eye Movement, AHI: Apnea/Hypopnea Index, CPAP: continuous positive airway pressure.
Please cite this article in press as: H. Shaarawy et al., Assessment of the effect of bariatric surgery on severe obstructive sleep apnea patients not tolerating CPAP therapy, Egypt. J. Chest Dis. Tuberc. (2016), http://dx.doi.org/10.1016/j.ejcdt.2016.04.007
4
H. Shaarawy et al. Table 3
Anthropometric and polysomnography data before and 12 months after surgery.
Character
Before surgery
After surgery
p value
Neck circumference in Cm Body weight in kg m Body mass index (kg/m2) Epworth Sleepiness Scale (ESS)
38.2 ± 3.6 135.6 ± 17.8 48.2 ± 7.3 16.8 ± 6.8
32.2 ± 4.6 101.3 ± 7.6 35.9 ± 4.8 10.2 ± 4.5
0.001** 0.001** 0.001** 0.001**
70.3 ± 3.64 69.6 ± 6.5 83.4 ± 2.3
71.5 ± 3.8 74.2 ± 3.4 82.6 ± 1.6
PFT FEV1% pred. FVC% pred. FEV1/FVC ratio Total sleep time (TST) in min. Sleep efficiency Non REM sleep time as % from TST REM sleep time as % from TST Arousal index/hour AHI/hour Lowest Sao2 during sleep Oxygen desaturation index 4% CPAP pressure after titration * **
358.1 ± 3.5 69.4 ± 3.25 75.3 ± 6.8 20.4 ± 2.9 40.6 ± 7.9 55.8 ± 8.3 67.2 ± 11.3 52.6 ± 6.5 13.2 ± 2.3 cm H2O
360.1 ± 1.5 75.4 ± 6.25 74.3 ± 7.8 22.4 ± 1.9 13.6 ± 8.9 12.8 ± 11.3 92.2 ± 5.3 10.6 ± 6.5 8.2 ± 3.9 cm H2O
0.04* 0.02* 0.06 0.09 0.04* 0.07 0.06 0.001** 0.001** 0.001** 0.001** 0.001**
Significant difference p < 0.05. Highly significant difference p < 0.01.
(p = 0.001) and lastly mean CPAP pressure needed to control OSA was decreased from 13.2 ± 2.3 to 8.2 ± 3.9 cm H2O and as mentioned before two patients had the AHI below 5 and did not need the CPAP again (Figs. 1 and 2). Discussion The aim of the present study was to assess the effect of bariatric surgery on patients with severe OSA, not tolerating CPAP therapy. This selected group of patients represents a medical problem as they are not compliant on the CPAP which is the gold standard therapy and at the same time they have almost no other option for treatment like mild to moderate cases with OSA. Alternative options include: oral appliances which according to the standards and guidelines, its major role for therapy appears to be the treatment of patients with mild-tomoderate OSA who cannot tolerate CPAP (and BiPAP) therapy. These devices are relatively unlikely to benefit patients with severe OSA [17,18]. Sleep surgery, on the other hand, has poor success rates. When the traditional surgical definition (50% reduction in AHI and/or 620) is applied, the pooled
Figure 1
Mean body weight before and 12 months after surgery.
Figure 2
Mean AHI before and 12 months after surgery.
success rate for phase I procedures (soft palate surgery with or without adjuvant treatment targeting base of tongue obstruction) is 55%, but with AHI 610 as a cut-off point, success rate decreases to 31.5%; and at AHI 65, success is reduced to 13% [19]. Studies have shown that the success rates of sleep surgery are lower in patients with an increased BMI [20,21]. As obesity is highly linked to OSA the only option for these patients is to lose weight which can help in decreasing AHI, lowering blood pressure, improving pulmonary function and arterial blood gas values, improving sleep structure and snoring, with possible reduction in optimum CPAP pressure required to control OSA [9–11]. In the present study patients were instructed to attempt losing weight twice and if failed bariatric surgery was offered as the last option. As is well-known by anesthesiologists, morbidly obese patients with OSAS present a formidable challenge throughout the peri-operative period. Life threatening problems can arise with respect to tracheal intubation, tracheal extubation, and the provision of satisfactory postoperative analgesia [22]. Furthermore, the
Please cite this article in press as: H. Shaarawy et al., Assessment of the effect of bariatric surgery on severe obstructive sleep apnea patients not tolerating CPAP therapy, Egypt. J. Chest Dis. Tuberc. (2016), http://dx.doi.org/10.1016/j.ejcdt.2016.04.007
Assessment of the effect of bariatric surgery on severe obstructive sleep apnea patients effect of bariatric surgery on the AHI is difficult to predict. As the pathogenesis of OSA in obese patients is not just due to local fatty deposition in the neck resulting in a reduction in the lumen of the upper airway thereby reducing airflow and inducing airway collapse, but is of a more complex nature, including factors such as age, sex, skeletal structures, neuromuscular, and metabolic function [23–25]. Thus, the pathogenesis and relationship of the extent of weight loss with improvement of OSA needs further investigation. From the above it is an important issue to put the bariatric surgery as a treatment option in OSA in the correct place to get the maximal benefit with avoidance of side effects of un-necessary surgery. If there is another option, in the present study we selected certain group of OSA patients who are not tolerating the CPAP and cannot lose weight with the normal measures. The results of the present study were encouraging as all patients had no complications and weight loss was significant with its effect on the BMI and AHI, 2 patients had complete cure of OSA and the AHI was below 5/h after 12 months from surgery, 20 patients still having OSA but to a lesser degree and in need of less CPAP pressure to control their disease. The results of our study add more evidence to the effect of bariatric surgery on severe OSA patients and increase the options of treatment for those problematic patients who are having severe OSA and refusing the CPAP machine, although these patients are more vulnerable to surgical complications; leaving them without treatment for OSA can lead to many complications or even sudden death during sleep. The results are in line with other studies having the same conclusion: Scheuller M, and Weider D [26] studied the long term effect of bariatric surgery in 15 morbidly obese patients with severe OSA, they followed the patients for up to 12 years and they concluded that bariatric surgery as a means of treating OSA in the morbidly obese provides effective long-term reduction in RDI. Bariatric surgery also significantly improves minimum oxygen saturation in morbidly obese patients with OSA. Fritscher LG et al. [27] studied the impact of bariatric surgery on obstructive sleep apnea in morbidly obese patients. The study was done on 13 patients with moderate to severe OSA. Patients were followed up for 18 months. The authors found a marked improvement in the RDI, mean and minimum oxygen saturation during sleep and they concluded that: weight loss achieved by bariatric surgery is associated with significant long-term improvements in obstructive respiratory event, oxygenation and resolution of daytime somnolence. Rao A et al. [28] studied the incidence of OSA in severely obese Asian patients and the effect of bariatric surgery on these patients, 250 obese patients were evaluated and severe OSA was discovered in 33% of patients while moderate OSA was discovered in 46% of patients after surgery. Patients were followed up until reaching the target body weight and then evaluated again with polysomnography. The authors concluded that the incidence of OSA in Asians undergoing bariatric surgery is high. Routine sleep studies in Asian patients are justified. Weight loss brought about a significant improvement in AHI and continuous positive airway pressure requirements. Ravesloot MJ et al. [29] measured the effect of bariatric surgery on various clinical, respiratory, and sleep parameters of OSA at two postoperative intervals at 6 and 12 months respectively. The study was done on 110 patients and the authors concluded that BS initiates dramatic improvement and even remission of clinical and sleep parameters during the first 7 months, which continues at a
slower rate over the next 10 months. They recommend a follow-up PSG after surgery to check for residual disease and if necessary retitration of continuous positive airway pressure, which may lead to higher treatment compliance. The present study has 2 main limitations: the first limitation is the small number of patients included and so, we recommend for larger studies on more patients to ensure the effect of bariatric surgery on these patients. The second limitation is the short period of follow up, may be with a longer period of follow up patients can lose more weight and this can improve the results or more patients can be completely cured and leave the CPAP. But we chose the period of one year as it is the period in which occurs most of the excess weight loss and even if continues it continues at a slower rate which may not affect the results significantly. Conclusion Sleeve gastrectomy can be an alternate option of treatment for severe OSA patients who are not tolerating CPAP and surgery may cure the disease or at least improve compliance to CPAP by decreasing the needed pressure to control OSA. Conflict of interest No conflict of interest. References [1] T. Young, M. Palta, J. Dempsey, J. Skatrud, S. Weber, S. Badr, The occurrence of sleep-disordered breathing among middleaged adults, N. Engl. J. Med. 328 (17) (1993) 1230–1235. [2] R.J. Schwab, M. Pasirstein, R. Pierson, A. Mackley, R. Hachadoorian, R. Arens, et al, Identification of upper airway anatomic risk factors for obstructive sleep apnea with volumetric magnetic resonance imaging, Am. J. Respir. Crit. Care Med. 168 (5) (2003) 522–530. [3] T. Young, L. Finn, P.E. Peppard, M. Szklo-Coxe, D. Austin, F. J. Nieto, et al, Sleep disordered breathing and mortality: eighteen-year follow-up of the Wisconsin sleep cohort, Sleep 31 (8) (2008) 1071–1078. [4] N.S. Marshall, K.K. Wong, P.Y. Liu, S.R. Cullen, M.W. Knuiman, R.R. Grunstein, Sleep apnea as an independent risk factor for all-cause mortality: the Busselton Health Study, Sleep 31 (8) (2008) 1079–1085. [5] N.M. Punjabi, B.S. Caffo, J.L. Goodwin, D.J. Gottlieb, A.B. Newman, G.T. O’Connor, et al, Sleep-disordered breathing and mortality: a prospective cohort study, PLoS Med. 6 (8) (2009) e1000132. [6] J. Rich, A. Raviv, N. Raviv, S.E. Brietzke, All-cause mortality and obstructive sleep apnea severity revisited, Otolaryngol. Head Neck Surg. 31 (3) (2012) 2012–2016. [7] A. Qaseem, J.E. Holty, D.K. Owens, et al, Management of obstructive sleep apnea in adults: a clinical practice guideline from the American College of Physicians, Ann. Intern. Med. (2013). Available at: http://annals.org/article.aspx?articleid= 1742606 (accessed August 13, 2014). [8] T.E. Weaver, R.R. Grunstei, Adherence to continuous positive airway pressure therapy, the challenge to effective treatment, Am. J. Respir. Crit. Care Med. 5 (2008) 173–178. [9] G.D. Foster, K.E. Borradaile, M.H. Sanders, R. Millman, G. Zammit, A.B. Newman, et al, A randomized study on the effect of weight loss on obstructive sleep apnea among obese patients with type 2 diabetes: the Sleep AHEAD study, Arch. Intern. Med. 169 (2009) 1619–1626.
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Please cite this article in press as: H. Shaarawy et al., Assessment of the effect of bariatric surgery on severe obstructive sleep apnea patients not tolerating CPAP therapy, Egypt. J. Chest Dis. Tuberc. (2016), http://dx.doi.org/10.1016/j.ejcdt.2016.04.007
H O S T E D BY
The Egyptian Society of Chest Diseases and Tuberculosis
Egyptian Journal of Chest Diseases and Tuberculosis www.elsevier.com/locate/ejcdt www.sciencedirect.com
ORIGINAL ARTICLE
Assessment of the effect of bariatric surgery on severe obstructive sleep apnea patients not tolerating CPAP therapy H. Shaarawy a,*, Abdelrahman Sarhan b, A. EL Hawary c a
Chest Diseases Department, Faculty of Medicine, Alex. University, Egypt General Surgery Department, Faculty of Medicine, Zagazig University, Egypt c Chest Diseases Department, Faculty of Medicine, Zagazig University, Egypt b
Received 11 December 2015; accepted 21 April 2016
KEYWORDS OSA; Sleeve gastrectomy; CPAP
Abstract Obstructive sleep apnea (OSA) is increasingly prevalent worldwide and is associated with morbidity and mortality, the main line of treatment is CPAP but the compliance is doubtful, as obesity is highly linked to OSA weight loss can help in treatment. The aim of the present study: was to assess the effect of bariatric surgery on severe obstructive sleep apnea patients not tolerating CPAP therapy. Patients and methods: the study was done on 22 patients documented to have morbid obesity (BMI > 40) and severe OSA with Apnea Hypopnea Index (AHI) >30/h and not tolerating CPAP therapy, patients were offered sleeve gastrectomy then were followed up for 12 months before another polysomnography was done to assess the presence of OSA and need for CPAP. Results: 22 patients completed the study. The mean age of the patients was 37.2 ± 17.3 years, 13 males and 9 females. After sleeve gastrectomy and follow up for 12 months the body weight decreased from 135.6 ± 17.8 to 101.3 ± 7.6 kg m (p = 0.001), BMI dropped from 48.2 ± 7.3 to 35.9 ± 4.8 kg m/m2 (p = 0.001), mean AHI decreased from 55.8 ± 8.3 to 12.8 ± 11.3 attacks/hour of sleep (p = 0.001) and CPAP pressure needed to control OSA was decreased from 13.2 ± 2.3 to 8.2 ± 3.9 cm H2O (p = 0.001). Conclusion: sleeve gastrectomy can be an alternate option of treatment for severe OSA patients who are not tolerating CPAP and surgery may cure the disease or at least improve compliance to CPAP by decreasing the needed pressure to control OSA. Ó 2016 The Egyptian Society of Chest Diseases and Tuberculosis. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-ncnd/4.0/).
Introduction
* Corresponding author. Peer review under responsibility of The Egyptian Society of Chest Diseases and Tuberculosis.
OSA is increasingly prevalent, in both adults and children, in modern society. The estimated prevalence has been 2% for women and 4% for men. More recent research indicates a prevalence of 4% for women and 9% for men. Data from the Wisconsin Cohort Study indicate that the prevalence of
http://dx.doi.org/10.1016/j.ejcdt.2016.04.007 0422-7638 Ó 2016 The Egyptian Society of Chest Diseases and Tuberculosis. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Please cite this article in press as: H. Shaarawy et al., Assessment of the effect of bariatric surgery on severe obstructive sleep apnea patients not tolerating CPAP therapy, Egypt. J. Chest Dis. Tuberc. (2016), http://dx.doi.org/10.1016/j.ejcdt.2016.04.007
2 OSA in people aged 30–60 years is 9–24% for men and 4–9% for women [1,2]. A recent study examining the association between OSA and mortality using portable sleep studies on more than 77,000 patients found that OSA was associated with all-cause mortality in patients younger than 50 years of age. While this is a general conclusion from the study, other variables played a substantial role in mediating this relationship. These data are consistent with earlier data showing that the negative impact of OSA on health is more profound in younger patients [3–6]. Currently, the treatment of choice for OSA is nasal continuous positive airway pressure (CPAP) [7]. Despite the documented efficacy of CPAP, it has been estimated that more than 50% of those patients started on CPAP will not be using it 1 year later [8]. Because obesity is a major predictive factor for OSA, weight reduction reduces the risk of OSA. The best data suggest that a 10% reduction in weight leads to a 26% reduction in the respiratory disturbance index (RDI). Benefits of weight reduction in patients with sleep disordered breathing SDB include the following: decreased RDI, lowered blood pressure, improved pulmonary function and arterial blood gas values, improved sleep structure and snoring, possible reduction in optimum CPAP pressure required [9–11]. In this respect bariatric surgery as therapy for OSA has been investigated in several nonrandomized, uncontrolled studies, with most showing a decrease in the AHI with weight loss. The 2006 practice parameter on medical therapies for OSAHS lists bariatric surgery as an option for OSA, although with limited evidence [12]. In a position paper on the treatment of OSA, the American Academy of Sleep Medicine (AASM) stated that bariatric surgery should be considered as an adjunct to less invasive and rapidly active first-line therapies such as positive airway pressure for patients who have OSA and meet the currently published guidelines for bariatric surgery (Consensus). The remission rate for OSA two years after bariatric surgery, related to the amount of weight lost, is 40%, emphasizing the need for ongoing clinical follow-up of these patients [13]. Aim of the work The aim of the present study is to assess the effect of bariatric surgery on severe obstructive sleep apnea patients not tolerating the CPAP therapy. Patients The study is a prospective single center observational study; it was done in the pulmonary rehabilitation center in association with the surgical department in Al-Amiri hospital, Ministry of Health, State of Kuwait in the period between June 2013 and July 2015. Patients were selected from those following up in sleep disorders clinic of the pulmonary rehabilitation center according to the following criteria: 1. Age: 18–55 years. 2. Patients proved to have severe obstructive sleep apnea (OSA) documented with polysomnography with Apnea Hypopnea Index (AHI) more than 30/hour of sleep.
H. Shaarawy et al. 3. Body mass index more than 40 kg/m2. 4. Attempt of losing weight was tried 2 times or more but failed. 5. Patients not tolerating CPAP therapy with documented compliance less than 4 h/night. 6. Patients must have no contraindication for surgery due to other co-morbidities. 7. Written consent was taken from all patients before indulging in the study. Methods All patients were subjected to the following: 1. 2. 3. 4. 5. 6. 7.
8. 9. 10.
11. 12.
History taking. Complete physical examination. Epworth Sleepiness Scale [14]. Body mass index derived from the weight and height formula (BMI = Wt in kg m/length in m2) [15]. Neck circumference. Pulmonary function testing. Arterial blood gases to make sure that the patient is not having obesity hypoventilation syndrome or any chronic respiratory disease. Chest X-ray. ECG. Pre-operative full night polysomnography using Alice 5 (Respironics) device including the following channels: electroencephalogram, electrooculogram, electromyogram, measurement of thoracic and abdominal movements, air flow detection, detection of intensity of snoring with pressure sensor, pulse oximetry to detect oxygen saturation and heart rate, position detection. According to polysomnography AHI was graded as mild if between 5 and 14 attacks/hour of sleep, moderate if between 15 and 30 attacks/hour of sleep, and severe if above 30/hour of sleep and the patient was included in the study only if having severe OSA. Pre-operative surgical assessment was done to assess for fitness for surgery. After taking written informed consent the patient was referred to surgical department for sleeve gastrectomy (the type of bariatric surgery used in the present study), it is done by removing part of the stomach along the greater curvature to leave only 25% of the original size of the stomach in the form of tube-like structure with capacity about 150 ml, procedure is simple and done through laparoscopy without affecting the absorption of nutrients and vitamins from the intestine [16]. All patients will receive prophylactic anticoagulant dose of unfractionated heparin 5000 IU subcutaneously immediately preoperatively and will also be treated with sequential compression devices. Patients will receive anticoagulants postoperatively for two weeks. CPAP was used in the immediate post-operative period and was used thereafter during sleep in the day and night until discharge from hospital, morphine-like drugs or medications that can affect the respiratory center was avoided during the post-operative period.
Please cite this article in press as: H. Shaarawy et al., Assessment of the effect of bariatric surgery on severe obstructive sleep apnea patients not tolerating CPAP therapy, Egypt. J. Chest Dis. Tuberc. (2016), http://dx.doi.org/10.1016/j.ejcdt.2016.04.007
Assessment of the effect of bariatric surgery on severe obstructive sleep apnea patients 13. After operation patients were followed up in the outpatient clinic for any complication of surgery and for the degree of weight loss. 14. After 12 months of follow up patients were assessed again for: Second time polysomnography was done for new assessment of the degree of OSA and for titration of CPAP pressure again if needed. Degree of weight loss. Body Mass Index. Pulmonary function testing. Epworth Sleepiness Scale.
Statistical analysis All statistical analyses were conducted using the software package SPSS 20.0 for WindowsÒ (SPSS Inc., Chicago, IL, USA). Data are presented as frequencies for categorical variables, and by mean ± standard deviation for numerical variables. Patients’ data were compared before and after surgery using dependent T-test, p values less than 0.05 were considered significant. Results The study was started with 30 patients having severe OSA and not tolerating the CPAP therapy, all patients offered the surgical options, 27 patients accepted and three patients refused the surgical option and was removed from the study, all the 27 patients had undergone the surgery without complications but during the period of follow up 5 patients were lost and did not continue the study. So the study was completed with 22 patients who completed the period of follow up for 12 months. Baseline epidemiologic and anthropometric data of the 22 patients who completed the study are presented in Table 1. From Table 1: the mean age of the patients was 37.2 ± 17.3 years, with 13 male and 9 female patients, the mean neck circumference of the patients was 38.2 ± 3.6 cm, baseline body weight was 135.6 ± 17.8 kg m, mean BMI was
48.2 ± 7.3 kg m/m2 denoting that all patients were in the range of morbid obesity, the mean ESS of the patients was 16.8 ± 6.8. Lastly pulmonary functions (PFT) of the studied group indicated mild restrictive pattern which is mostly due to obesity as chronic respiratory illness was excluded. From Table 2 the TST of the studied patient was 358.1 ± 3.5 min with a sleep efficiency of 69.4 ± 3.25%, the percentage of non REM sleep from the TST was 75.3 ± 6.8%, while the percentage of REM sleep from the TST was 20.4 ± 2.9%, the mean arousal index during sleep was markedly increased denoting disturbed sleep in these patients (40.6 ± 7.9/h) which can affect the quality of life, the total AHI during sleep was 55.8 ± 8.3/h which denotes that all patients had severe degree of OSA, the lowest oxygen saturation reached during sleep was 67.2 ± 11.3%, mean ODI4% was 52.6 ± 6.5/hour of sleep, the mean CPAP pressure titrated for the studied patients was 13.2 ± 2.3 cm H2O. After surgery patients were followed up for 12 months for the degree of weight loss and any possible complication of surgery or recurrence of symptoms of OSA, 2 patients had complete remission of OSA with the AHI dropping below 5 attacks/hour of sleep while 20 patient still had OSA but to a lesser degree than before surgery. A comparison of anthropometric and polysomnography data before and after surgery is presented in Table 3. Table 3 shows a significant decrease in all anthropometric data of the patients, mean neck circumference dropped from 38.2 ± 3.6 to 32.2 ± 4.6 cm (p = 0.001), mean body weight dropped from 135.6 ± 17.8 to 101.3 ± 7.6 kg m (p = 0.001), mean BMI dropped from 48.2 ± 7.3 to 35.9 ± 4.8 kg m/m2 (p = 0.001), consequently this drop was reflected on the ESS which decreased from 16.8 ± 6.8 to 10.2 ± 3.5 (p = 0.001) and on the pulmonary function parameters which improved as follows: FEV1% pred. was increased from 70.3 ± 3.64 to 71.5 ± 3.8 (p = 0.04) and FVC% pred. was increased from 69.6 ± 6.5 to 74.2 ± 3.4 (p = 0.02). As regards the polysomnography data sleep efficiency was increased from 69.4 ± 3.25 to 75.4 ± 6.25 (p = 0.04), mean lowest Sao2 during sleep was increased from 67.2 ± 11.3 to 92.2 ± 5.3% (p = 0.001), mean AHI was decreased from 55.8 ± 8.3 to 12.8 ± 11.3 attacks/hour of sleep (p = 0.001), mean arousal index was decreased from 40.6 ± 7.9 to 13.6 ± 8.9/hour of sleep (p = 0.001), mean oxygen desaturation index 4% was decreased from 52.6 ± 6.5 to 10.6 ± 6.5/hour of sleep
Table 1 Baseline epidemiologic and anthropometric data of patients. Character
Mean ± SD
No. of patients Age in years Gender: male/female ratio Neck circumference in Cm Baseline body weight in kg m Body mass index (kg/m2) Epworth Sleepiness Scale (ESS)
22 37.2 ± 17.3 13/9 38.2 ± 3.6 135.6 ± 17.8 48.2 ± 7.3 16.8 ± 6.8
PFT FEV1% pred. FVC% pred. FEV1/FVC ratio
70.3 ± 3.64 69.6 ± 6.5 83.4 ± 2.3
FEV1: forced expiratory volume in the first second, FVC: forced vital capacity.
Table 2 Baseline polysomnography data of the patients before surgery. Character
Mean ± SD
Total sleep time (TST) in min. Sleep efficiency Non REM sleep time as % from TST REM sleep time as % from TST Arousal index/hour AHI/hour Lowest Sao2 during sleep Oxygen desaturation index 4% CPAP pressure after titration
358.1 ± 3.5 69.4 ± 3.25 75.3 ± 6.8 20.4 ± 2.9 40.6 ± 7.9 55.8 ± 8.3 67.2 ± 11.3 52.6 ± 6.5 13.2 ± 2.3 cm H2O
REM: Rapid Eye Movement, AHI: Apnea/Hypopnea Index, CPAP: continuous positive airway pressure.
Please cite this article in press as: H. Shaarawy et al., Assessment of the effect of bariatric surgery on severe obstructive sleep apnea patients not tolerating CPAP therapy, Egypt. J. Chest Dis. Tuberc. (2016), http://dx.doi.org/10.1016/j.ejcdt.2016.04.007
4
H. Shaarawy et al. Table 3
Anthropometric and polysomnography data before and 12 months after surgery.
Character
Before surgery
After surgery
p value
Neck circumference in Cm Body weight in kg m Body mass index (kg/m2) Epworth Sleepiness Scale (ESS)
38.2 ± 3.6 135.6 ± 17.8 48.2 ± 7.3 16.8 ± 6.8
32.2 ± 4.6 101.3 ± 7.6 35.9 ± 4.8 10.2 ± 4.5
0.001** 0.001** 0.001** 0.001**
70.3 ± 3.64 69.6 ± 6.5 83.4 ± 2.3
71.5 ± 3.8 74.2 ± 3.4 82.6 ± 1.6
PFT FEV1% pred. FVC% pred. FEV1/FVC ratio Total sleep time (TST) in min. Sleep efficiency Non REM sleep time as % from TST REM sleep time as % from TST Arousal index/hour AHI/hour Lowest Sao2 during sleep Oxygen desaturation index 4% CPAP pressure after titration * **
358.1 ± 3.5 69.4 ± 3.25 75.3 ± 6.8 20.4 ± 2.9 40.6 ± 7.9 55.8 ± 8.3 67.2 ± 11.3 52.6 ± 6.5 13.2 ± 2.3 cm H2O
360.1 ± 1.5 75.4 ± 6.25 74.3 ± 7.8 22.4 ± 1.9 13.6 ± 8.9 12.8 ± 11.3 92.2 ± 5.3 10.6 ± 6.5 8.2 ± 3.9 cm H2O
0.04* 0.02* 0.06 0.09 0.04* 0.07 0.06 0.001** 0.001** 0.001** 0.001** 0.001**
Significant difference p < 0.05. Highly significant difference p < 0.01.
(p = 0.001) and lastly mean CPAP pressure needed to control OSA was decreased from 13.2 ± 2.3 to 8.2 ± 3.9 cm H2O and as mentioned before two patients had the AHI below 5 and did not need the CPAP again (Figs. 1 and 2). Discussion The aim of the present study was to assess the effect of bariatric surgery on patients with severe OSA, not tolerating CPAP therapy. This selected group of patients represents a medical problem as they are not compliant on the CPAP which is the gold standard therapy and at the same time they have almost no other option for treatment like mild to moderate cases with OSA. Alternative options include: oral appliances which according to the standards and guidelines, its major role for therapy appears to be the treatment of patients with mild-tomoderate OSA who cannot tolerate CPAP (and BiPAP) therapy. These devices are relatively unlikely to benefit patients with severe OSA [17,18]. Sleep surgery, on the other hand, has poor success rates. When the traditional surgical definition (50% reduction in AHI and/or 620) is applied, the pooled
Figure 1
Mean body weight before and 12 months after surgery.
Figure 2
Mean AHI before and 12 months after surgery.
success rate for phase I procedures (soft palate surgery with or without adjuvant treatment targeting base of tongue obstruction) is 55%, but with AHI 610 as a cut-off point, success rate decreases to 31.5%; and at AHI 65, success is reduced to 13% [19]. Studies have shown that the success rates of sleep surgery are lower in patients with an increased BMI [20,21]. As obesity is highly linked to OSA the only option for these patients is to lose weight which can help in decreasing AHI, lowering blood pressure, improving pulmonary function and arterial blood gas values, improving sleep structure and snoring, with possible reduction in optimum CPAP pressure required to control OSA [9–11]. In the present study patients were instructed to attempt losing weight twice and if failed bariatric surgery was offered as the last option. As is well-known by anesthesiologists, morbidly obese patients with OSAS present a formidable challenge throughout the peri-operative period. Life threatening problems can arise with respect to tracheal intubation, tracheal extubation, and the provision of satisfactory postoperative analgesia [22]. Furthermore, the
Please cite this article in press as: H. Shaarawy et al., Assessment of the effect of bariatric surgery on severe obstructive sleep apnea patients not tolerating CPAP therapy, Egypt. J. Chest Dis. Tuberc. (2016), http://dx.doi.org/10.1016/j.ejcdt.2016.04.007
Assessment of the effect of bariatric surgery on severe obstructive sleep apnea patients effect of bariatric surgery on the AHI is difficult to predict. As the pathogenesis of OSA in obese patients is not just due to local fatty deposition in the neck resulting in a reduction in the lumen of the upper airway thereby reducing airflow and inducing airway collapse, but is of a more complex nature, including factors such as age, sex, skeletal structures, neuromuscular, and metabolic function [23–25]. Thus, the pathogenesis and relationship of the extent of weight loss with improvement of OSA needs further investigation. From the above it is an important issue to put the bariatric surgery as a treatment option in OSA in the correct place to get the maximal benefit with avoidance of side effects of un-necessary surgery. If there is another option, in the present study we selected certain group of OSA patients who are not tolerating the CPAP and cannot lose weight with the normal measures. The results of the present study were encouraging as all patients had no complications and weight loss was significant with its effect on the BMI and AHI, 2 patients had complete cure of OSA and the AHI was below 5/h after 12 months from surgery, 20 patients still having OSA but to a lesser degree and in need of less CPAP pressure to control their disease. The results of our study add more evidence to the effect of bariatric surgery on severe OSA patients and increase the options of treatment for those problematic patients who are having severe OSA and refusing the CPAP machine, although these patients are more vulnerable to surgical complications; leaving them without treatment for OSA can lead to many complications or even sudden death during sleep. The results are in line with other studies having the same conclusion: Scheuller M, and Weider D [26] studied the long term effect of bariatric surgery in 15 morbidly obese patients with severe OSA, they followed the patients for up to 12 years and they concluded that bariatric surgery as a means of treating OSA in the morbidly obese provides effective long-term reduction in RDI. Bariatric surgery also significantly improves minimum oxygen saturation in morbidly obese patients with OSA. Fritscher LG et al. [27] studied the impact of bariatric surgery on obstructive sleep apnea in morbidly obese patients. The study was done on 13 patients with moderate to severe OSA. Patients were followed up for 18 months. The authors found a marked improvement in the RDI, mean and minimum oxygen saturation during sleep and they concluded that: weight loss achieved by bariatric surgery is associated with significant long-term improvements in obstructive respiratory event, oxygenation and resolution of daytime somnolence. Rao A et al. [28] studied the incidence of OSA in severely obese Asian patients and the effect of bariatric surgery on these patients, 250 obese patients were evaluated and severe OSA was discovered in 33% of patients while moderate OSA was discovered in 46% of patients after surgery. Patients were followed up until reaching the target body weight and then evaluated again with polysomnography. The authors concluded that the incidence of OSA in Asians undergoing bariatric surgery is high. Routine sleep studies in Asian patients are justified. Weight loss brought about a significant improvement in AHI and continuous positive airway pressure requirements. Ravesloot MJ et al. [29] measured the effect of bariatric surgery on various clinical, respiratory, and sleep parameters of OSA at two postoperative intervals at 6 and 12 months respectively. The study was done on 110 patients and the authors concluded that BS initiates dramatic improvement and even remission of clinical and sleep parameters during the first 7 months, which continues at a
slower rate over the next 10 months. They recommend a follow-up PSG after surgery to check for residual disease and if necessary retitration of continuous positive airway pressure, which may lead to higher treatment compliance. The present study has 2 main limitations: the first limitation is the small number of patients included and so, we recommend for larger studies on more patients to ensure the effect of bariatric surgery on these patients. The second limitation is the short period of follow up, may be with a longer period of follow up patients can lose more weight and this can improve the results or more patients can be completely cured and leave the CPAP. But we chose the period of one year as it is the period in which occurs most of the excess weight loss and even if continues it continues at a slower rate which may not affect the results significantly. Conclusion Sleeve gastrectomy can be an alternate option of treatment for severe OSA patients who are not tolerating CPAP and surgery may cure the disease or at least improve compliance to CPAP by decreasing the needed pressure to control OSA. Conflict of interest No conflict of interest. References [1] T. Young, M. Palta, J. Dempsey, J. Skatrud, S. Weber, S. Badr, The occurrence of sleep-disordered breathing among middleaged adults, N. Engl. J. Med. 328 (17) (1993) 1230–1235. [2] R.J. Schwab, M. Pasirstein, R. Pierson, A. Mackley, R. Hachadoorian, R. Arens, et al, Identification of upper airway anatomic risk factors for obstructive sleep apnea with volumetric magnetic resonance imaging, Am. J. Respir. Crit. Care Med. 168 (5) (2003) 522–530. [3] T. Young, L. Finn, P.E. Peppard, M. Szklo-Coxe, D. Austin, F. J. Nieto, et al, Sleep disordered breathing and mortality: eighteen-year follow-up of the Wisconsin sleep cohort, Sleep 31 (8) (2008) 1071–1078. [4] N.S. Marshall, K.K. Wong, P.Y. Liu, S.R. Cullen, M.W. Knuiman, R.R. Grunstein, Sleep apnea as an independent risk factor for all-cause mortality: the Busselton Health Study, Sleep 31 (8) (2008) 1079–1085. [5] N.M. Punjabi, B.S. Caffo, J.L. Goodwin, D.J. Gottlieb, A.B. Newman, G.T. O’Connor, et al, Sleep-disordered breathing and mortality: a prospective cohort study, PLoS Med. 6 (8) (2009) e1000132. [6] J. Rich, A. Raviv, N. Raviv, S.E. Brietzke, All-cause mortality and obstructive sleep apnea severity revisited, Otolaryngol. Head Neck Surg. 31 (3) (2012) 2012–2016. [7] A. Qaseem, J.E. Holty, D.K. Owens, et al, Management of obstructive sleep apnea in adults: a clinical practice guideline from the American College of Physicians, Ann. Intern. Med. (2013). Available at: http://annals.org/article.aspx?articleid= 1742606 (accessed August 13, 2014). [8] T.E. Weaver, R.R. Grunstei, Adherence to continuous positive airway pressure therapy, the challenge to effective treatment, Am. J. Respir. Crit. Care Med. 5 (2008) 173–178. [9] G.D. Foster, K.E. Borradaile, M.H. Sanders, R. Millman, G. Zammit, A.B. Newman, et al, A randomized study on the effect of weight loss on obstructive sleep apnea among obese patients with type 2 diabetes: the Sleep AHEAD study, Arch. Intern. Med. 169 (2009) 1619–1626.
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Please cite this article in press as: H. Shaarawy et al., Assessment of the effect of bariatric surgery on severe obstructive sleep apnea patients not tolerating CPAP therapy, Egypt. J. Chest Dis. Tuberc. (2016), http://dx.doi.org/10.1016/j.ejcdt.2016.04.007