Potentially cost-effective addition to standard GERD management in post-transplant patients
A novel sleep positioning device (SPD) significantly reduces acid exposure and improves lung function in lung transplant recipients with gastroesophageal reflux disease (GERD), according to research presented during the American College of Gastroenterology (ACG) Annual Scientific Meeting. The retrospective study from the Cleveland Clinic found that SPD use led to substantial improvements in forced expiratory volume (FEV1) and resolution of nighttime reflux among most patients.
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“Patients went from having reflux 15% of the time at night — about five times the normal threshold — to just 2.2%,” says study author Scott Gabbard, MD, a gastroenterologist at Cleveland Clinic. “Among patients who had reflux at night, 73% experienced complete resolution.”
These findings offer a promising, cost-effective adjunct to traditional GERD management in a vulnerable post-transplant population where reflux has been strongly linked to graft dysfunction.
GERD is a known risk factor for chronic lung allograft dysfunction (CLAD), a leading cause of morbidity and mortality in lung transplant recipients. While proton pump inhibitors (PPIs) reduce acid production, they do not prevent reflux events or mitigate the harmful effects of non-acidic contents, such as bile or digestive enzymes, particularly during sleep.
“Reflux is really a valve problem, where the bottom valve of the esophagus opens when it’s not supposed to,” Dr. Gabbard explains. “The medicine doesn’t prevent things from coming back up. All it does is prevent the stomach from making acid so that the patient doesn’t feel it.”
Anti-reflux surgery is effective but often contraindicated in transplant patients due to altered gastrointestinal motility or comorbidities. This created a critical gap in treatment options, one that the Cleveland Clinic team sought to address through the use of a sleep positioning device.
The research effort, titled “Impact of Sleep Positioning Device on Acid Exposure and Outcomes in Lung Transplant Recipients with Gastroesophageal Reflux,” is a single-center cohort study. It included 20 lung transplant recipients (2014–2019) with documented GERD who were prescribed the SPD within two years post-transplant. Outcomes were compared to a historical control group of 54 transplant recipients (2011–2013) with GERD managed with PPIs alone.
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The SPD is a wedge-like pillow that locks users into a left lateral decubitus position, an orientation that positions the esophagus above the stomach, using gravity to reduce reflux events. Pre- and post-intervention data were collected for FEV1 values, and 15 SPD users underwent ambulatory pH monitoring to assess acid exposure.
The use of the sleep positioning device led to meaningful improvements in both reflux control and pulmonary function in lung transplant recipients with GERD. Among patients who underwent pre- and post-intervention ambulatory pH monitoring, supine acid exposure time dropped significantly—from a median of 15% to 2.2% (p < .0001). Total acid exposure time also decreased, from a median of 11% to 4.3% (p = .015). Supine reflux resolved in 11 of 15 (73.1%) patients.
The intervention also appeared to positively influence graft stability and lung function. “We use what is called the FEV1 percentage, which is the measurement of how much air someone can blow out in one second,” notes Dr. Gabbard. “This is a marker of how well the lungs are working.”
At six months post-transplant, SPD users had a mean predicted FEV1 of 80%, compared to 69% in the control group. At one year, SPD users again maintained a mean FEV1 of 80%, while controls were at 71%. Additionally, the researchers found that post-SPD FEV1 was higher than pre–SPD FEV1 among patients who used the sleep positioning device (82% vs. 70%).
“These data show that this approach does appear to positively affect the pulmonary function of patients after transplant,” says Dr. Gabbard, while adding, “Seeing that level of improvement within just a few months of using the device was very encouraging.”
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The findings are particularly important because lung transplant recipients often face a period of early graft improvement followed by steady functional deterioration. “Typically, after a lung transplant, patients have about a three-month window during which lung function improves as they recover,” Dr. Gabbard elaborates. “After that, there's usually a gradual decline. Our goal is to slow that decline. And in this study, we saw a clear trend toward stabilization of lung function in patients using the sleep positioning device.”
This research highlights the importance of managing GERD in lung transplant recipients and introduces a practical, non-invasive intervention for patients who are not surgical candidates. Historically, patients with esophageal dysmotility or delayed gastric emptying were limited to acid-suppressive medications alone. “Now, we can offer a mechanical solution that’s inexpensive, non-invasive, and effective. That’s a big step forward,” notes Dr. Gabbard.
The sleep positioning device has been standard of care at Cleveland Clinic since 2014. “The study essentially validates what we’ve been doing and confirms that the transplant director’s intuition was correct,” Dr. Gabbard shares. He also emphasizes the accessibility and value of the device. “It’s worth noting that the device is relatively inexpensive, particularly in the context of a lung transplant, which can cost hundreds of thousands of dollars. This is a very small investment with potentially significant benefits.”
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Looking ahead, large-scale randomized trials may be difficult due to cost and ethical considerations. “Ideally, we’d love to our work to be replicated at another site. But the reality is that while the device is affordable, conducting a prospective randomized trial is very expensive,” says Dr. Gabbard. “What I would like to see is other centers begin using the device, then evaluating its effectiveness in their own populations retrospectively. That’s more realistic.”
The broader adoption of SPD could also impact transplant eligibility. “At our center, we’re fairly aggressive in transplanting patients that other centers might turn away,” he explains. “Part of that is because we have tools like this—non-surgical interventions that help us manage complex cases. If more centers adopt this approach, it could expand transplant eligibility for many patients.”
“We hope this encourages other transplant centers to start looking more closely at nighttime reflux and consider non-surgical options like this device, especially for patients who aren’t surgical candidates,” Dr. Gabbard concludes.
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