Utilisation of surgical fundoplication for patients with gastro-oesophageal reflux disease in the USA has declined rapidly between 2009 and 2013

Transcription

1 Alimentary Pharmacology and Therapeutics Utilisation of surgical fundoplication for patients with gastro-oesophageal reflux disease in the USA has declined rapidly between 29 and 213 F. Khan*, C. Maradey-Romero*, S. Ganocy, R. Frazier* & R. Fass* *The Esophageal and Swallowing Center, Division of Gastroenterology and Hepatology, MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH, USA. Center Health Care Research and Policy, Case Western Reserve University at MetroHealth Medical Center, Cleveland, OH, USA. Correspondence to: Prof. R. Fass, Case Western Reserve University, Division of Gastroenterology and Hepatology, Esophageal and Swallowing Center, MetroHealth Medical Center, 25 MetroHealth Drive, Cleveland, OH 4419, USA. Publication data Submitted 25 January 216 First decision 6 February 216 Resubmitted 3 March 216 Resubmitted 1 March 216 Resubmitted 11 March 216 Accepted 13 March 216 EV Pub Online 6 April 216 This article was accepted for publication after full peer-review. SUMMARY Background Surgical fundoplication has been considered to be one of the leading therapeutic modalities for gastro-oesophageal reflux disease (GERD) during the last several decades. Aim To determine the trend of surgical fundoplication utilisation in GERD patients during the last decade in the United States. Methods Population-based study using a large nationwide database, the Explorys database system, to identify patients diagnosed with GERD and those who underwent surgical fundoplication. Using a quadratic regression model, we determined and compared the trends of surgical fundoplication utilisation annually from 24 to 213. Results We identified patients with the diagnosis of GERD, of whom 2343 (.5%) underwent surgical fundoplication between 24 and 213. There was a significant decline in the number of surgical fundoplications performed over the last 5 years from.62% in 29 to.47% in 213 (P <.5). Female patients accounted for the majority of those who underwent fundoplication (62.52%). Caucasian patients between the ages of 18 and 65 years were the most likely group to undergo surgical fundoplication (66.28%). The number of overweight patients undergoing surgical fundoplication has been significantly increasing over the last decade (P <.5). Importantly, 8% of surgical patients were treated with a proton pump inhibitor (PPI) post surgical fundoplication by 213 (P <.1). Conclusions Utilisation of surgical fundoplication in GERD patients has been steadily declining over the past 5 years. The vast majority of patients will resume PPI treatment after surgical fundoplication. Aliment Pharmacol Ther 216; 43: doi:1.1111/apt.13611

2 GERD and surgical fundoplication INTRODUCTION Gastro-oesophageal reflux disease (GERD) is the most common gastrointestinal diagnosis recorded during visits to out-patient clinics. 1 It is a common condition in the USA and affects >4% of the adult population monthly. Moreover, 2% of the population is troubled with heartburn symptoms on a weekly basis, and 7% experience heartburn daily. 2 Currently, several therapeutic strategies are available, and these include medical, surgical or endoscopic interventions. 3 Medical therapy is the most common therapeutic modality presently utilised in clinical practice. 4 Proton pump inhibitors (PPIs), histamine 2 receptor antagonists (H2RAs), sucralfate, Gaviscon, baclofen, antacids and prokinetics are some of the most commonly used medications for treating GERD. 5 Endoscopic therapies include the Stretta procedure and transoral incisionless fundoplication. Despite the availability of medical and endoscopic therapeutic modalities, many patients prefer a durable surgical intervention that will prevent the need for long-term use of anti-reflux medications with their potential for short- and long-term adverse effects. Nissen fundoplication is the most widely used surgical intervention for GERD, 6 and refractory GERD is currently the most common indication for laparoscopic anti-reflux surgery. 7 Complete fundoplication is created with a 36 wrap of the fundus around the distal portion of the oesophagus to create a new anti-reflux barrier. Overall, approximately 8% of GERD patients demonstrate a good long-term outcome 2 years post-surgery when the anti-reflux procedure was performed by an experienced surgeon. 8 1 Various modifications of surgical fundoplication are available and are tailored to specific clinical situations. Examples include posterior (Toupet) fundoplication and anterior (Dor) fundoplication. 11 The benefits of surgery, however, must be weighed against potential adverse effects and the long-term outcome of the procedure. 12 These include short- and longterm complications such as dysphagia, inability to belch or vomit, diarrhoea, bloating, abdominal pain and constipation. 13, 14 In addition, wrap failure may occur over time with various presentations. This may result, among others, in symptom recurrence and subsequent need to resume some level of medical therapy. 15 Surgical management is indicated for patients who fail optimal medical management, are not interested in longterm medical therapy, are noncompliant with anti-reflux medications, have volume reflux and/or large hiatal hernia, and demonstrate severe oesophagitis or benign stricture on upper endoscopy. 16 Several predictors for success of anti-reflux surgery have been identified, and these include careful pre-operative assessment of patients, expertise of the surgeon and complete relief of symptoms while on medical anti-reflux treatment. 17 Recent years have seen several changes in the therapeutic landscape of GERD. There is a marked decline in the development of new medical therapeutic modalities, but a significant increase in the development of nonmedical (endoscopic and surgical) techniques. There has also been growing recognition of the important limitations of surgical fundoplication for providing patients with an effective, safe long-term solution. Consequently, the aim of this study was to determine the trend of surgical fundoplication utilisation in patients with GERD during the last decade by using a large national database. METHODS Database description Explorys is a private, cloud-based data store. Explorys uses a stringent de-identified process that precludes the investigators from seeing institution level data. De-identified data were obtained using the Explore application of the Explorys platform (Explorys Inc, Cleveland, OH, USA). This places a healthcare gateway server behind the firewall of each participating healthcare institution. The data were collected from a variety of health information systems and include billing inquiries, electronic health records and laboratory systems. These data were then processed and placed onto a data grid. A web application allows each healthcare organisation to search and analyse the aggregated, standardised, normalised and de-identified population level data. With over 315 billion clinical, financial and operation data elements spanning 5 million unique patients, 36 hospitals and over 317 providers, Explorys secure cloud-computing platform is being used by 26 major integrated healthcare systems to identify patterns in diseases, treatments and outcomes. The network includes hospitals in all 5 states. Data collection Data were collected using the Explorys which integrates electronic non-identifiable patient data used by 26 major healthcare systems. We identified patients with the Aliment Pharmacol Ther 216; 43:

3 F. Khan et al. diagnosis of GERD (defined by ICD-9 code criteria) aged 18 years who underwent surgical fundoplication (defined by ICD-9 code) between 24 and 213. Patients who underwent surgical fundoplication were further stratified by age, sex, racial group and BMI. Patients who were younger than 18 years were excluded from the study. Ten-year increments were used to group and analyse the age of the population. Statistical analysis Chi-squared tests were used to test for differences among levels of categorical variables such as sex and race. The Cochran Armitage test was used to assess the overall trend in categorical variables over the 1-year time period. Exploratory data analysis, including a plot of the annual use of fundoplication over the 1-year period, suggested that the trend for usage of this procedure was nonlinear between 24 and 213. Therefore, a second-order (quadratic) regression model was used to describe the trajectory of the annual percentage of surgical fundoplications performed over this time period. SAS version 9.3 statistical software was used for data analysis. The type I error rate was set at.5. It should be noted that the Explorys data source rounds cell counts to the nearest 1, and treats all cell counts <1 as equal to zero. RESULTS Using this large database, we identified cases with the diagnosis of GERD between 24 and 213. A total of 2343 patients (.5%) underwent surgical fundoplication for GERD. There were 1465 female patients (62.52%), which constituted the majority of the population studied (see Figure 1). The number of Caucasian patients undergoing the surgery (77.67%, P <.1) was significantly higher compared with other racial groups. Patients between ages 18 and 65 years were significantly more likely to undergo surgical fundoplication (66.28%) compared with patients older than 65 years (see Figures 2 and 3). Patients were further divided into four categories based on BMI: normal, overweight, obesity I and obesity II. The number of overweight patients undergoing surgical fundoplication has increased significantly over the last decade (P =.3) as compared with the other BMI categories (see Figure 4). A significant increase was noted in the percentage of surgical fundoplication cases from 24 through 29, with a downward trend from 29 to 213. A steady, statistically significant decline in the percentage of surgical fundoplication has occurred over the last 5 years, from.62% in 29 to.47% in 213 (P <.5) (see Figure 5). The rate of surgical fundoplications performed in 213 (.47%) has dropped to the level of surgical fundoplications performed a decade ago (.41%). Overall, there was a 48.8% increase in the utilisation rate of surgical fundoplication from 24 to 29. However, there was a 23% decline in the utilisation rate of surgical fundoplication from 29 to 213. Furthermore, there was a significant increase in PPI consumption over the last 1 years (P <.1). Importantly, the 8 7 Female Male 6 5 % patients Figure 1 Gender distribution among 2343 GERD patients who underwent surgical fundoplication between 24 and 213 (P =.41) Aliment Pharmacol Ther 216; 43:

4 GERD and surgical fundoplication Figure 2 Ethnic distribution among 2343 GERD patients who underwent surgical fundoplication between 24 and 213. There was a statistically significant difference between Caucasians and the other ethnic groups (P <.1). % patients 6 5 Caucasian African American 4 Hispanics Other years >65 years 7 6 % patients 5 4 Figure 3 Age distribution, divided to years and >65 years, among 2343 GERD patients who underwent surgical fundoplication between 24 and 213 (P =.12) increase in the percentage of patients treated with a PPI and/or H2RA post surgical fundoplication was specifically observed between 21 and 213, nearly doubling the percentage of patients who were treated with anti-reflux medication post surgical fundoplication (see Figure 6). Furthermore, there was a 99.8% increase in the rate of bariatric surgery performed in the same GERD population between 29 and 213, which was statistically significant (<.5). DISCUSSION In this population-based study using a large, administrative de-identified nationwide database, we have demonstrated that the utilisation rate of surgical fundoplication in GERD patients has been declining to the level observed about a decade ago. Our study demonstrated a 48.8% increase in the number of surgical fundoplications between years 24 and 29 (from.41% to.61%). After reaching a peak in 29, there was a steady decline Aliment Pharmacol Ther 216; 43:

5 F. Khan et al Normal Obesity I Overweight Obesity II % of patients Figure 4 BMI distribution among 2343 GERD patients who underwent surgical fundoplication between 24 and 213. There was a statistically significant difference between the number of overweight patients undergoing surgery and the other BMI groups (P =.3). % of patients underwent surgical fundoplication Figure 5 Utilisation of surgical fundoplication among 2343 GERD patients between 24 and 213. There was a statistically significant decline in the rate of surgical fundoplication during the period of 29 and 213 (P =.44). in the percentage of surgical fundoplication until 213, when it reached the same rate as that about a decade ago. While other authors found similar declines in the utilisation of surgical fundoplication, our study is the first to demonstrate a continued decline to the level seen 1 years ago. Wang et al. also reported the trend of anti-reflux surgery utilisation between 1993 and 26 in the USA. 18 The authors found that the number of in-patient antireflux surgeries peaked at in 2, followed by a 4% decrease in the rate (n = ) of anti-reflux surgeries by 26. Recently, Funk et al. evaluated the trend of utilisation of elective anti-reflux surgery in the USA from 25 to By using the Nationwide Inpatient Sample database, the authors reported a decrease in elective fundoplication from (5.3 cases per 1 people) in 25 to (4.8 cases per 1 people) in 28. However, the study showed an increase in the number of surgical fundoplications performed in 21 (18 78, 6.1 cases per 1 people). Overall, the authors demonstrated a decline in the utilisation of surgical fundoplication of nearly two-thirds as compared with its peak between 1999 and 2. Both studies reported that the majority of patients who 1128 Aliment Pharmacol Ther 216; 43:

6 GERD and surgical fundoplication 9 8 PPI H2RA 7 6 Figure 6 Distribution of PPI and H2 receptor antagonists utilisation post-surgical fundoplication among 2343 GERD patients who underwent the procedure between 24 and 213. There was a statistically significant increase in anti-reflux medications consumptions during this period of time (P <.1). % of patients years underwent surgical fundoplication were female, which was consistent with the results of our study. The reasons for the rapid decline in utilisation of surgical fundoplication during the last 5 years remains to be further elucidated. It is likely that multiple different reasons, rather than a single reason, led to this decline. It is possible that patient concerns about short- and longterm adverse effects, the need for reoperation and the high relapse rate of GERD-related symptoms post surgery have played an important role in this decline. 18 The rapid increase in the utilisation of bariatric surgery in the general population over the period of time of our study assessment may have also played a role in the decline. 2 In our study, there was in particular a decline in the rate of surgical fundoplication utilisation in patients with obesity type II, while at the same time there was a significant increase in the utilisation of bariatric surgery in the GERD population. Thus, it is possible that some of the patients were offered gastric bypass instead of surgical fundoplication for their GERD symptoms. 21 However, the rate of bariatric surgery performance has been increasing steadily throughout the study duration and not just during the period between 29 and 213. In addition, it is difficult to know from the database if GERD patients received bariatric surgery in lieu of surgical fundoplication or just because of their obesity. It is unclear if the availability of a new anti-reflux surgical technique, the magnetic sphincter augmentation device (LINX Reflux Management System Torax Medical, Shoreview, MN, USA), contributed to the decline of surgical fundoplication. 22 However, the decline in surgical fundoplications had already been seen prior to the introduction of the LINX procedure, and thus it was unlikely to be the direct cause of the decline in surgical rates. It is also unclear if the introduction of a new endoscopic technique for GERD and the increased utilisation of another technique, which is already available in the market, contributed to the decline of surgical fundoplication. 14 The Stretta procedure (Mederi Therapeutics Inc., Greenwich, CT, USA), which delivers radiofrequency energy into the gastro-oesophageal junction and thus reduces the frequency of transient lower oesophageal sphincter relaxations, has been in the market for almost 15 years. While this technique has undergone several upgrades, it is unlikely to have an impact on the rate of surgical fundoplication. The new endoscopic technique, EsophyX (EndoGastric Solutions, Redmond, WA, USA), which is used to perform transoral incisionless fundoplication, has seen significant growth in the number of procedures done in patients with GERD who opted for nonsurgical treatment over the last few years. 14 However, it is unlikely to be the direct cause for the decline of surgical fundoplication, primarily because this endoscopic technique was introduced into the market only about 3 years ago. Spechler et al. demonstrated that 62% of patients who underwent surgical fundoplication were back on antireflux medication for GERD-related symptoms years post surgery (P <.1). 15 Our study results Aliment Pharmacol Ther 216; 43:

7 F. Khan et al. (i.e. the high usage of anti-reflux medications after surgery) are consistent with the study by Spechler et al. Interestingly, the percent of patients who were taking a PPI despite surgical fundoplication increased from 45.5% to 8% between 21 and 213. The reason for the marked increase in the utilisation of PPIs post surgical fundoplication remains to be fully elucidated. However, it is possible that the common availability of this class of drugs over the counter or in a generic form may have played some role in this phenomenon. Our study has several limitations that need to be discussed. The results are based on the Explorys data set, which originates from 26 major healthcare systems and overall 36 hospitals. This vast data set is de-identified and thus may not reveal regional or individual hospital trends. Contribution to the data set originates from many hospitals around the country, but this may not truly represent the diverse healthcare system in the USA. Furthermore, the diagnosis of GERD and the performance of surgical fundoplication were based on ICD-9 codes rather than full chart review. Moreover, the type of surgical fundoplication may not be determined from the Explorys data set. However, we assessed all techniques of surgical fundoplication in this study and did not focus on a specific technique. We assumed that all surgical fundoplications were performed for GERD, but some patients (albeit very few) might have had the surgery for non-gerd-related reasons such as Heller myotomy. However, we included only GERD patients who underwent surgical fundoplication and excluded those with achalasia. Lastly, we could not determine the exact period of time that lapsed between surgical fundoplication and resumption of anti-reflux medications including PPIs and H2RAs. However, we assume that patients were back on anti-reflux medication between 1 and 9 years post surgical fundoplication since we studied a 1-year period. In summary, despite the general acceptance of antireflux surgery for many years as an effective therapeutic modality for GERD, a significant decline in utilisation has been seen in the last 5 years. Also, 8% of patients who underwent surgical fundoplication were back on PPI therapy by the year 213. The exact reason for the decline in utilisation of surgical fundoplication, as well as the increase in consumption of anti-reflux medications post surgery, remains to be fully elucidated. Importantly, it is possible that future improvements in medical and endoscopic therapeutic modalities will result in a further decline in surgical fundoplication, potentially further limiting its utilisation. AUTHORSHIP Guarantor of the article: Ronnie Fass. Author contributions: Freeha Khan contributed towards data collection, data analysis and manuscript development. Carla Maradey-Romero contributed towards data analysis and manuscript development. Stephen Ganocy was involved in the statistical analysis. 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