RefluxStop surgery in the treatment of acid reflux

RefluxStop surgery is an innovative and highly effective procedure for the treatment of chronic gastroesophageal reflux disease (GERD), addressing the root causes of acid reflux while minimizing common side effects associated with traditional surgical approaches like Nissen fundoplication. Below is a detailed explanation of the procedure, its mechanism, clinical outcomes, and advantages:

### **Mechanism of RefluxStop Surgery**

RefluxStop is designed to correct all three components of the anti-reflux barrier:

1. **Crural Diaphragm:** The procedure restores the natural anatomy by maintaining the lower esophageal sphincter (LES) below the diaphragm, reducing the risk of reflux.

2. **Lower Esophageal Sphincter (LES):** It repositions the LES to improve its function without applying external pressure or encircling it, which avoids complications like dysphagia.

3. **Gastroesophageal Flap Valve:** The surgery reconstructs the flap valve to enhance reflux resistance while preserving the natural mechanics of swallowing.

Unlike fundoplication, RefluxStop avoids wrapping or compressing the esophagus and stomach, which minimizes postoperative issues such as gas-bloating and difficulty swallowing.

### **Clinical Outcomes**

The RefluxStop procedure has demonstrated exceptional safety and effectiveness in a prospective multicenter study conducted over a mean follow-up period of 5.7 years. Key findings include:

1. **Symptom Relief:**

• GERD symptom improvement was dramatic, with a 90% reduction in GERD-HRQL (Health-Related Quality of Life) scores. Median scores decreased from 29.5 at baseline to 3.0 at 5 years (p<0.001), indicating substantial long-term relief.

2. **Objective Acid Control:**

• Esophageal acid exposure time decreased by 90.4%, from 16.35% at baseline to 1.57% at 5 years (p<0.001). This confirms durable control of acid reflux, comparable to or better than traditional surgical outcomes.

3. **PPI Discontinuation:**

• At 5 years, 97.9% of patients were no longer taking daily proton pump inhibitors (PPIs). Only one patient resumed PPIs, but for unrelated kidney disease rather than reflux recurrence.

4. **Regurgitation Control:**

• 93.6% of patients reported no or minimal regurgitation at 5 years, demonstrating the procedure’s ability to prevent mechanical reflux through effective LES repositioning and flap valve restoration.

5. **Device Stability:**

• No instances of device migration, dislocation, erosion, or explantation were observed over the entire study period, highlighting the long-term integrity of the implant.

### **Safety Profile**

The procedure has shown an excellent safety record:

1. **Adverse Events:**

• Across five years, no device-related adverse events (ADEs or SADEs) occurred. Two severe postoperative complications (bleeding and infection) resolved completely without long-term consequences.

2. **Postoperative Dysphagia:**

• Only one patient (2%) experienced transient mild dysphagia, which resolved within the study period. Overall, 97.9% of patients reported no dysphagia, a significant advantage over fundoplication techniques.

3. **Gastritis Symptoms:**

• Eight patients experienced gastritis-related symptoms, but these were isolated and not indicative of surgical failure or reflux recurrence.

### **Comparison to Nissen Fundoplication**

RefluxStop surgery offers several advantages over traditional fundoplication:

1. **Preservation of Normal Function:**

• Unlike fundoplication, which causes dysphagia in nearly 29% of patients and gas-bloating in over 50%, RefluxStop preserved full ability to belch and vomit (100%) and eliminated bloating in 95.7% of patients.

2. **Minimized Complications:**

• By avoiding wrapping the stomach around the esophagus, RefluxStop reduces mechanical pressure on the LES, preventing long-term esophageal complications and postoperative discomfort.

### **Durability and Long-Term Effectiveness**

RefluxStop surgery has demonstrated durable results:

1. **Stable Acid Exposure:**

• Acid exposure time remained low and stable between the 6-month (0.82%) and 5-year (1.57%) evaluations, confirming the mechanical and functional longevity of the anti-reflux barrier reconstruction.

2. **Quality of Life:**

• Patients experienced sustained symptom relief and improved quality of life, with minimal dependence on medication.

### **Procedure-Specific Safety**

RefluxStop avoids the invasive wrapping technique used in fundoplication, reducing the risk of complications like dysphagia, gas-bloating, and esophageal pressure damage. Early procedural refinements—such as ensuring proper fundic pouch tension and LES positioning—eliminated minor complications, demonstrating the reliability of the surgical technique.

### **Real-World Data Support**

Independent European centers replicated the study’s findings, confirming consistent efficacy and safety across varied populations, including patients with large hiatal hernias and impaired esophageal motility.

### **Regulatory Validation**

The study data were rigorously audited and independently verified by FDA consultants and third-party CROs, supporting the reliability of the safety and efficacy results. The procedure has received CE mark approval and is undergoing FDA PMA (Premarket Approval) submission.

### **Clinical Implications**

RefluxStop surgery represents a paradigm shift in GERD management, offering:

1. Sustained symptom relief (>90% improvement).

2. Near-complete medication independence (97.9% off PPIs).

3. Minimal adverse effects (low dysphagia rates and no device-related complications).

4. Preservation of natural swallowing mechanics and belching ability.

5. Durable acid reflux control over the long term.

This procedure has the potential to redefine the standard of care for long-term surgical correction of GERD, providing a safer and more effective alternative to traditional techniques like fundoplication.