Edited by: Angel Lanas, University of Zaragoza, Spain
Reviewed by: Francisco Schlottmann, Hospital Alemán, Argentina; Vivek Kaul, University of Rochester, United States
This article was submitted to Gastroenterology, a section of the journal Frontiers in Medicine
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Gastroesophageal reflux disease (GERD) is a complex disease process that affects ~20% of adults in the US (
The effective treatment of GERD patients requires an awareness of the clinical spectrum of GERD and its varied symptomatology, associated comorbidities, and potential complications. Despite the prevalence and impact of GERD, the patient and treatment pathways for a considerable number of patients with GERD are suboptimal (
Centers of excellence (CoEs) are specialized programs that supply high concentrations of expertise and related resources centered on particular medical areas and delivered in a comprehensive, interdisciplinary fashion (
In order to optimize treatment options for GERD, the concept of a “Heartburn Center” as a CoE in foregut disease is emerging as our understanding of the management of the array of esophageal diseases continues to grow (
While significant strides have been made in defining the quality of GERD care in an integrated CoE (
The concept of the interdisciplinary practice model was first introduced to our hospital leadership team in early 2016 by a surgeon and GI. St. Joseph's Physicians Surgical Services, part of St. Joseph's Hospital Health Center, offers comprehensive surgical care for ambulatory, elective and critically ill patients. Surgical services range from oncology, bariatric, including both laparoscopic and robotic surgeries. As illustrated in
Development of a new practice model for heartburn center of excellence.
To provide optimal patient care, it is critical that evidence-based multi-disciplinary referral pathways are set up that include but are not limited to patients, PCPs, GIs, ear, nose, and throat physicians (ENTs), pulmonary physicians, emergency physicians, and surgeons.
Organizational structure of the practice model for our heartburn center of excellence.
GIs should be a part of the core group and should be involved early in the patient's treatment decision. A previous administrative claims database analysis that examined healthcare resource utilization of patients with a diagnosis of GERD found that esophageal objective testing was inadequate when patients were not referred to GIs, and furthermore, timely transfer of GERD patients to GIs when empiric treatment is insufficient may lead to improved clinical management (
An optimized program has well-coordinated milestones of timely consultation, diagnostic workup, a documented treatment plan, and regular follow-up.
For patients to be funneled into the center, we developed a patient outreach program that facilitated patient flow, importantly with dedicated program coordinator and director. Such a program ensured patient education about the center's value proposition and differentiation from other similar centers in the region. Centers may consider developing a hub to receive dedicated calls from potential patients and appropriate referrals. Following referral, it is critical to set outcome expectations with the patient and expectations of downstream effect.
A digital platform that facilitates patient progress tracking throughout their continuum of care and also facilitates comprehensive data collection regarding the effectiveness of such a center is vital for a service line center. An integrated implementation of such a platform with the Epic electronic health record (Epic Corporation, Madison, WI) system at our center facilitated referrals from primary care and ED. Especially patients who came to the ED with chest pain and who were typically sent back if no cardiac involvement was determined, are now being regularly referred to the HBC with improved disease awareness of atypical symptoms of GERD as well as the facility to seamlessly refer those patients to the HBC.
Having a protocol for appropriate identification of patients is important. Esophageal objective testing is required to anatomically and physiologically evaluate the presence and progression of GERD in patients being considered for surgery. Founded on evidence- and experienced-based consensus (
We set up a treatment protocol for every patient prior to the start of disease management. We have described the selection criteria in our manuscript which is based on patients Symptoms, EMS study, pH study, Endoscopy, Barium swallow study and GAD-Generalized Anxiety score and patient preference. Our protocol dictates that post-diagnostic workup, the patient be offered treatments based on the pathology and to rule out other intra-abdominal pathologies such as gallbladder or peptic ulcer disease that may be potentially misdiagnosed as reflux disease. Patients who are candidates for anti-reflux surgery are given options to undergo either a hiatal hernia repair with magnetic sphincter augmentation device implant/LINX® procedure or a robotic hiatal hernia procedure with a posterior robotic Toupet fundoplication (RTF). Patients with a BMI >35 are first educated about lifestyle modification including weight loss or referred to a bariatric surgeon if surgery is indicated. Patients with any anxiety causing esophageal symptoms are referred to a gut psychologist. Importantly, recurring clinical meetings and grand rounds are setup with core physicians to discuss an optimal treatment plan for each patient.
The patients in the center are typically followed at 2, 8 weeks, 6 months and 1 year in the postoperative period in patients with LINX® procedure and fundoplications. The patients are surveyed and their HRQL scores are calculated at each visit.
Central to the HBC is the surgeon and GI partners. It is critical that the surgeons have foregut surgery experience and that the GIs are experienced in foregut physiology and pathology and are willing to follow established pre-surgery diagnostic pathways including manometry and pH testing, understand the US payer environment, and importantly have demonstrated history of collaborating with administration and colleagues.
Ancillary physicians may include a gut psychologist, pulmonologist, ENT specialists, bariatric surgeon, and nutritionist. A supportive staff of healthcare providers should include a program coordinator, nurse practitioners, physician assistants, and a nutritionist. Finally, it is important to partner with the hospital administration such as a program director who has the authority to approve new programs or looking to establish leadership in a particular disease area.
We followed patients over 2 years from initial consultation to completion of an appropriate treatment plan.
The study included patients who were 21 years of age and older, had a history of typical or atypical GERD symptoms, at least 8 weeks of once or twice daily PPI therapy with or without breakthrough symptoms, actively seeking alternative surgical treatment options for bothersome GERD symptoms including, but not limited to heartburn, regurgitation, and dysphagia. Subjects were willing and able to cooperate with follow-up examinations. For those having LINX® implanted, the LINX® Instruction for Use (IFU) (
Subjects with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials, esophageal dysmotility, connective tissue disorders, or severe anxiety symptoms.
Baseline demographic characteristics of patients presenting to the HBC.
All | 832 | 100% |
Age | ||
<19 | 2 | 0.2% |
19 to 25 | 39 | 4.7% |
26 to 45 | 247 | 29.7% |
46 to 65 | 378 | 45.4% |
> 65 | 166 | 20.0% |
Gender | ||
Female | 500 | 60.1% |
Male | 332 | 39.9% |
Race | ||
Caucasian | 691 | 83.1% |
Black or African American | 59 | 7.1% |
Asian | 14 | 1.7% |
Hispanic | 26 | 3.1% |
American Indian/Alaska Native | 0 | 0.0% |
Other | 42 | 5.0% |
Unknown/Refused | 0 | 0.0% |
Health insurance payer | ||
Medicaid/Molina/Fidelis/Government plans | 235 | 28.2% |
Commercial | 411 | 49.4% |
Medicare | 186 | 22.4% |
Baseline clinical characteristics of patients presenting to the HBC.
All | 832 | 100% |
Body mass index (BMI) | ||
<18.5 (Underweight) | 6 | 0.7% |
18.5–24.9 (Normal) | 165 | 20.2% |
25.0–29.9 (Overweight) | 266 | 32.6% |
30.0–<35.0 (Obesity Class I) | 219 | 26.8% |
35.0–<40.0 (Obesity Class II) | 99 | 12.1% |
40.0+ (Obesity Class III) | 62 | 7.6% |
Charlson comorbidity score | ||
0 | 469 | 56.4% |
1–2 | 265 | 31.9% |
3–4 | 80 | 9.6% |
≥5 | 18 | 2.2% |
Comorbidities | ||
Myocardial infarction | 40 | 4.8% |
Congestive heart failure | 12 | 1.4% |
Peripheral vascular disease | 35 | 4.2% |
Cerebrovascular disease | 32 | 3.8% |
Chronic pulmonary disease | 140 | 16.8% |
Connective tissue disease-rheumatic disease | 38 | 4.6% |
Peptic ulcer disease | 15 | 1.8% |
Mild liver disease | 17 | 2.0% |
Diabetes without complications | 22 | 2.6% |
Diabetes with complications | 88 | 10.6% |
Paraplegia and hemiplegia | 12 | 1.4% |
Renal Disease | 52 | 6.3% |
Moderate or severe liver disease | 51 | 6.1% |
Type of symptoms | ||
Typical | 602 | 72.4% |
Atypical | 230 | 27.6% |
Duration of GERD (years) | ||
<1 | 71 | 8.5% |
1–3 | 153 | 18.4% |
4–7 | 187 | 22.5% |
8–11 | 160 | 19.2% |
12–15 | 80 | 9.6% |
15+ | 181 | 21.8% |
Duration Medication Use (PPI/H2/Other/Combo) (years) | ||
<1 | 53/28/2/7 | 6.4/3.4/0.2/0.8% |
1–3 | 91/21/2/20 | 10.9/2.5/0.2/2.4% |
4–7 | 100/19/4/22 | 12.0/2.3/0.5/2.6% |
8–11 | 96/10/2/19 | 11.5/1.2/0.2/2.3% |
12–15 | 50/5/3/15 | 6.0/0.6/0.4/1.8% |
15+ | 124/11/9/30 | 14.9/1.3/1.1/3.6% |
Barrett's Esophagus | ||
Short segment | 33 | 4.0% |
Long segment | 5 | 0.6% |
Dysplasia | 2 | 0.2% |
Approximately one in five patients had normal weight, one-third were overweight, and the remainder (46.5%) were obese (
More than one-quarter of patients with GERD had atypical symptoms (27.6%). <10% of patients had GERD for <1 year, ~60% had GERD for 1–11 years, and 3 in 10 patients had GERD for 12 or more years. Only 6.4% of patients had been on PPIs for less than a year and more than 20% of patients had been on PPIs for 12 or more years. Thirty-eight patients had Barrett's esophagus (4.6%) (
Trends in the performance of the HBC were assessed over 2 years, specifically 2017–2019, and benchmarked across four different metrics: referrals, patient volumes, length of stay, and HRQL.
The primary source of referrals were self-referrals (patients from advertisements, television events, print, public patient seminars (24%), GI (20%), primary care centers (54%), with others from emergency department (ED) and specialty services. Most notably, GIs were a
These patients were distributed across 79 zip codes around the HBC. Although there are hospitals in this catchment area that are larger than ours in terms of patient volumes, our HBC is capturing a larger share of the GERD patients due to our integrated care approach for these patients.
As illustrated in
Upward trend in total anti-reflux procedure (pre-surgery diagnostics and surgical) volumes in our heartburn center.
The uptick in volumes was across the board including pre-surgery diagnostics as well as anti-reflux surgical procedures. Importantly, an integrated approach provided the larger institution an opportunity to adopt novel surgical procedures such as LINX®, as well as non-surgical endoscopic procedures such as Radiofrequency Ablation, Endoscopic Mucosal Resections that were not performed prior to the start of the HBC.
As depicted in
Patient volumes as a percentage of the total pre-surgery diagnostics and surgical volumes.
The length of stays (LOS) for the two important anti-reflux procedures, LINX® and RTF, were recorded. As illustrated in
Trends in average length of stay for the two primary anti-reflux surgeries conducted at our heartburn center.
Patients implanted with LINX® as well as those who underwent RTF demonstrated a statistically significant improvement in GERD-HRQL score at 8 weeks compared to baseline: An average score of 24 (range 36–0) vs. 6 (range 28–0) in LINX® patients and 23 (range 41–0) vs. 5 (range 23–0) in the RTF population. As illustrated in
Two-year trends in HRQL scores for patients undergoing LINX® and RTF.
An integrated GERD service line center offers a comprehensive, multi-specialty, and coordinated patient-centered approach. Ranging from initial consultation and diagnosis to surgical intervention for complex disease, such an approach is likely to provide optimal care and provide surveillance for patients for a complex disease process of GERD.
In this article, we reported our approach to a practice model of an integrated HBC based on our experience at our facility. The integrated approach drove quality and efficiency in terms of coordinated care that enabled care cross-over and efficient resource utilization. Furthermore, setting up treatment protocols and defining patient pathways standardized the workflow and provided a definition of the center. Importantly, local outreach and marketing helped develop interpersonal relationships with referral physicians resulting in recognition of the center as a “Real Antireflux Heartburn Center.” That in turn promoted specialization and differentiation from competition, leading to superior results for our HBC both in terms of patient volumes and patient care. Following an audit of the retrospective data presented here, the regional Excellus BlueCros BlueShield now considers the LINX® device implant a medically necessary procedure and provides insurance coverage to its 1.5 million members (
The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
All authors listed have made a substantial, direct and intellectual contribution to the work, and approved it for publication.
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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Aniket Maini for proof reading and assisting in compiling the data in the paper.