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Perioperative management - EndoStim® Stimulation Therapy of the Lower Esophageal Sphincter

  1. Indications

    The treatment of reflux disease is primarily conservative-medication-based (proton pump inhibitors, PPI).

    Therapeutic goals for GERD are:

    • Symptom relief or at least satisfactory symptom control
    • Normalization of quality of life and work ability
    • Remission of any existing reflux esophagitis
    • Long-term maintenance of remission (symptoms, lesions)
    • Prevention of complications

    The indication for surgical antireflux therapy is given for:

    • Long-standing reflux symptoms with intolerance to proton pump inhibitors or patient preference
    • Volume reflux (e.g., massive reflux of stomach contents in an upright body position, when bending over, or even during sleep, possibly with aspiration)
    • Extraesophageal GERD symptoms (reflux cough, pharyngitis, asthma) that cannot be fully controlled by PPI or intolerance to PPI.
    • Persistent symptoms despite adequate PPI dosage and clearly proven reflux disease (e.g., due to PPI resistance or accelerated PPI metabolism)

    EndoStim® is a less invasive, alternative surgical method compared to fundoplication. A pacemaker system is implanted to strengthen the lower esophageal sphincter.

    Additional indications for EndoStim® therapy are particularly

    • Therapy-resistant GERD patients who reject traditional anti-reflux surgery due to its potential side effects

    or in cases of contraindications for fundoplication such as

    • Previous "sleeve gastrectomy" as part of bariatric surgery
    • Disturbance of esophageal motility

    The advantage over the standard operation is that the anatomy of the stomach and esophagus is hardly altered. This reduces the risk of side effects such as swallowing difficulties and bloating. Additionally, the procedure is fundamentally reversible. If problems arise, the device can be turned off or removed.

  2. Contraindications

    There are no contraindications for EndoStim® stimulation therapy, provided that a subtle preoperative diagnosis has correctly identified a reflux disease.

    Exclusion criteria differ little from conventional antireflux surgery and include:

    • Esophageal motility disorders without reflux (e.g., achalasia)
    • Secondary reflux, e.g., due to gastric emptying disorders
    • Esophagitis of other origins (infectious, drug-induced toxic)
    • Extraesophageal diseases with reflux-like symptoms, e.g., coronary artery disease
  3. Diagnostics

    There is no diagnostic gold standard for diagnosing "GERD," so diagnostics should primarily be symptom-oriented. Although diagnostic steps vary from clinic to clinic, objective morphological and functional examinations are required before surgical measures, particularly for documentation of the indication.

    1. Medical History

    Lower Reflux Symptoms

    • Heartburn
    • Belching (acidic, non-acidic)
    • Retrosternal pain
    • Dysphagia
    • Odynophagia (pain on swallowing, rare)

    Upper Reflux Symptoms

    • Burning in the throat
    • Regurgitation
    • Chronic cough/morning throat clearing
    • Hoarse voice, hoarseness
    • Asthma attacks

    Triggering or exacerbation of symptoms by: food intake, prolonged fasting, sweet foods, alcohol, bent body position, and lying down. Symptoms can occur episodically, intermittently, or persistently. Spontaneous remissions are possible but unlikely to be permanent.

    The type, intensity, and frequency of reflux symptoms do not allow conclusions about the severity of the reflux disease or the extent of esophageal lesions.

    Heartburn is the most sensitive symptom of reflux disease. If it is the main symptom, reflux is present with a probability of > 75%. If heartburn plays a minor role and other symptoms are predominant, other diseases are more likely (e.g., functional dyspepsia or ulcer). The absence of heartburn does not exclude reflux disease. Dysphagia, retrosternal discomfort, and respiratory symptoms may dominate the symptomatology in reflux disease but are still nonspecific.

    During the medical history assessment, previous conservative-medication treatment should also be investigated, and any existing previous findings should be reviewed.

    2. PPI Test

    A complete or significant response to PPI administration suggests the presence of reflux disease, or in other words: if high-dose PPI therapy fails, the presence of GERD is unlikely.

    The PPI test is only useful for symptoms that already suggest reflux disease, while endoscopy is simultaneously unremarkable. The PPI test should be conducted with two to three times the standard dosage recommended for reflux treatment over at least 2 weeks, as reflux episodes can vary from day to day without therapy or occur only intermittently.

    3. Endoscopy

    The importance of esophagogastroduodenoscopy in reflux diagnostics is undisputed and mandatory before surgical intervention. It enables:

    • Diagnosis of reflux esophagitis and assessment of its severity (also as follow-up control in esophagitis therapy)
    • Diagnosis of a hiatal hernia
    • Detection of complications (stricture, ulcer)
    • Exclusion of malignancy

    Early endoscopy is indicated for unusually severe symptoms and alarm symptoms such as anemia, dysphagia, and weight loss. Obtaining histology is mandatory for all macroscopic abnormalities.

    4. 24-Hour Esophageal pH Monitoring

    The 24-hour esophageal pH monitoring is the gold standard for objectifying gastroesophageal reflux. It records the circadian rhythm of reflux episodes, physical activities, food intake, and body positions. Symptom correlation with the recorded reflux episodes is possible through patient self-documentation of symptoms, increasing the sensitivity of pH monitoring. The diagnosis of reflux esophagitis cannot be derived from the pH monitoring result; endoscopy is required for this.

    A 24-hour pH monitoring is indicated for:

    • Preoperative documentation of the surgical indication
    • Persistence of reflux symptoms under adequate PPI medication
    • In endoscopically unremarkable "NERD" patients (= Non Erosive Reflux Disease)
    • Recurrent reflux symptoms after antireflux surgery

    In pH monitoring, it must be noted that up to 25% of patients with reflux esophagitis and around 30% of NERD patients have normal values, which is due to the fact that even with clear reflux disease, the amount of reflux can vary from day to day.

    5. Esophageal Manometry

    Esophageal manometry can reliably assess the competence of the LES (resting pressure, length) and the tubular motility of the esophagus. Contraction amplitudes of the tubular esophagus below 30 mm Hg are considered hypomobile, and a resting pressure of the LES less than 5 mm Hg is considered reduced.

    Esophageal manometry plays no role in the primary diagnosis of GERD but can be useful in individual cases to differentiate other esophageal motility disorders (e.g., achalasia). It is highly recommended in the context of preoperative evaluation and documentation regarding the selection of the surgical procedure. If tubular contraction disorders of the esophagus are detected, a Toupet or Nissen fundoplication should be avoided.

    6. X-ray/Barium Swallow

    Using barium, radiological reflux documentation can attempt to provoke reflux through provocation maneuvers (head-down and abdominal position, Valsalva maneuver). However, a sole "barium swallow" is not suitable for diagnosing GERD for the following reasons:

    • Reflux is physiological, so no pathological value can be derived from the radiological representation.
    • Reflux occurs intermittently and can only be reliably detected through long-term measurement, not through a radiological snapshot.

    However, the barium swallow remains the gold standard for detecting an axial hiatal hernia and allows differentiation of various hernia types. Many surgeons also find the barium swallow helpful for visualizing the anatomy of the gastroesophageal junction before planned surgery.

    Note:

    Before antireflux surgery, endoscopy should always be performed. Before deciding on surgery, functional tests such as pH monitoring and manometry are recommended, especially for documentation of findings. If a hiatal hernia is present, its extent can be very well depicted using a barium swallow.

  4. Special Preparation

    • Single-shot antibiotic i.v. perioperatively (due to the use of foreign material)
    • mild laxative the day before
  5. Informed consent

    General Risks

    • Bleeding
    • Rebleeding
    • Need for transfusions with associated transfusion risks
    • Thromboembolism
    • Wound infection
    • Abscess
    • Injury to adjacent organs/structures (here: esophagus, stomach, liver, spleen)

    Specific Risks

    • Postoperative dysphagia
    • Intraoperative pneumothorax, possibly requiring chest drainage
    • Pericardial lesion
    • Denervation syndrome due to damage to the anterior or posterior vagus branch (consequence: gastric emptying disorder, diarrhea)
    • Lack of success (despite correct indication and surgical technique)
  6. Anesthesia

    Intubation anesthesia with capnoperitoneum

  7. Positioning

    Positioning
    • Supine position
    • Adduction of both arms
  8. OR Setup

    • Surgeon: to the left of the patient
    • Assistant: to the right of the patient opposite the surgeon
    • Scrub nurse: to the left of the surgeon
    • 2 monitors on the right and left at the level of the patient's shoulders
  9. Special Instruments and Retention Systems

    Special Instruments and Retention Systems

    Basic Equipment MIC:

    • CO₂ insufflator, camera, monitor, light source, high-frequency coagulation

    Instruments:

    • 5mm 30° optic
    • one 12mm and three to four 5mm trocars
    • laparoscopic needle holder
    • atraumatic 5mm grasping forceps, 5mm Overholt clamp
    • 5mm irrigation and suction optional
    • ultrasonic dissector

    Electrostimulation:

    EndoStim® consists of 3 components:

    • Implantable pulse generator that emits electrical impulses with a strength of 5–8 mA at a frequency of 20 Hz.
    • Implantable electrodes with bipolar lead
    • External programming device that modifies stimulation parameters and records therapy statistics.
  10. Postoperative Treatment

    Postoperative Analgesia:

    Medical Follow-up Treatment:

    • The therapy is initiated 6-12 hours after implantation.
    • Discharge on the 1st postoperative day
    • PPIs should be continued in the initial phase and gradually reduced and discontinued over time (96% of patients are PPI-free after 12 months).
    • Removal of skin suture material around the 10th postoperative day if not absorbable

    Thrombosis Prophylaxis:

    • In the absence of contraindications, due to the moderate thromboembolic risk (surgical procedure > 30 minutes duration), low molecular weight heparin should be administered in prophylactic, possibly weight- or disposition risk-adjusted dosage until full mobilization is achieved. Note: renal function, HIT II (history, platelet control).
    • Follow the link here to the current guideline Prophylaxis of venous thromboembolism (VTE).

    Mobilization:

    • immediate mobilization, standing up on the day of surgery

    Physical Therapy:

    not required

    Dietary Progression:

    • in the initial phase of therapy “Post-Fundoplication Diet”

    Bowel Regulation:

    • if necessary, oral laxatives to prevent postoperative bowel atony

    Incapacity for Work:

    • individual, depending on the occupation, between 2 and 4 weeks