This is the first prospective study investigating the safety and efficacy of electrical lower esophageal sphincter stimulation in patients with GERD and IEM. The data presented provide evidence that LES-EST is safe and does not impact postoperative swallowing in this special subgroup of surgical GERD patients and is effective 1 month after surgery.
Ineffective esophageal motility is frequently seen in patients with GERD . However, the association between GERD and IEM is yet not fully understood and discussed very controversially [13, 14]. Notably, there are numerous reports, which show a possible connection between the IEM and impaired mucosal integrity caused by GERD [12, 15, 16].
With the introduction of the high resolution manometry, the diagnosis of IEM has been updated . Definition of IEM was changed from the conventional manometry, contractions exhibiting amplitudes < 30 mmHg, to the use of the DCI, not exceeding 450 mmHg s cm in ≥ 50% of the swallows . This might jeopardize comparability to earlier studies dealing with anti-reflux surgery in patients with esophageal dysmotility. To our knowledge, this is the first prospective trial investigating anti-reflux surgery in patients with IEM using the updated Chicago classification.
Novitzky et al. published a retrospective analysis of patients with severe dysmotility undergoing LF . Although these were not IEM patients, according to the actual classification, an early dysphagia rate of 73% was reported, which required several interventions. Finally, only in 4.2% of the cases dysphagia remained persistent. Postoperative dysphagia severely impacts patient’s well-being. It is only recently that Kapadia et al. published the relationship between HRM findings and postoperative dysphagia. Although patients did not meet the Chicago criteria v3.0 of IEM in this series, they could show a significant correlation between preoperative DCI and post-fundoplication dysphagia .
LES-EST was introduced by Rodriguez et al. in 2012 showing that LES pressure could be increased significantly by controlled electric stimulation, without causing any complaint of dysphagia . It is of significant advantage that LES stimulation does not have any effect on the LES relaxation or esophageal body function .
The presence of dysphagia after LES-EST has been described differently depending on simultaneous hiatal repair [10, 11]. The primary open-label trial did not show any signs of dysphagia . Remarkably, no patients underwent hiatal repair due to strict inclusion criteria. However, in the international multicenter trial patients with small and medium sized hiatal hernia were included . For the first time, a mild dysphagia rate was reported in the interim results. Four out of 42 patients mentioned mild to moderate dysphagia. All 4 patients underwent hiatal repair as well and dysphagia resolved without intervention.
In our study, the majority of patients underwent hiatal repair (70.6%). Yet, the crural repair before electrode implantation did not have any impact on postoperative dysphagia.
However, hiatal repair on its own might have an anti-reflux effect. There is an ongoing discussion about the effect of hiatal repair in anti-reflux surgery. A recently published comparative cohort study showed no improvement in patients who underwent hiatal repair without LNF or EGJ augmentation. New-onset abnormal acid exposure after surgery was seen in 38.9% of patients . Although hiatal repair plays a significant role in anti-reflux surgery, this study found no satisfying primary effect. However, due to our low treatment number we cannot assess the role of hiatal repair in our collective.
This study has some limitations that need to be addressed. With regard to patient satisfaction and quality of life scores, there might be a placebo effect 1 month after surgery. This study, however, was designed to investigate dysphagia and GI side effects in a complex patient group. Those findings are much less influenced by a placebo effect. Taken into account the limited patient number, our results cannot be easily generalized.
In our personal experience, anti-reflux surgery in this patient group can be quite challenging. This newly established operation technique might have a place in foregut surgery. This enables surgeons to offer a personalized therapy option and can therefore reduce adverse effects. Despite the positive findings regarding GI symptoms after surgery, reflux control remains the key goal. Long-term monitoring of symptoms and objective pH measurements should be the subsequent step to endorse these findings.