Electrical stimulation as an alternative treatment in gastroesophageal reflux disease - clinical study

Abstract

Background: Recently, there was described the possibility to increase the lower esophageal sphincter (LES) tone by means of implantable electrical stimulator. Although, this method has already been used in clinical practice, however, the optimal parameters of LES electrical stimulation are still unknown. Aims: The goals of this study were to get clinical data regarding the effects of different types of electrical stimulation on LES and to elaborate and test the prototype on laboratory animals. Material and Methods: In the Department of Surgery no 4, during 4 years (2015-2018), there has been achieved one clinical-experimental study of LES electrical stimulation. During the first stage, the electrical stimulation of the LES, using an external pulse generator, was assessed in 15 patients. These patients underwent an antireflux intervention, with an additional insertion of 2 temporary electrodes on the LES. During the second stage, there was created an experimental device which consisted of a re-insertable microstimulator using wireless energy transfer. During the third stage, it was tested in the experimental surgery center "Pius Brânzeu", Timişoara, on laboratory animals (pigs). Results: Values of the LES resting pressure and integrated relaxation pressure (IRP) were significantly different during the prestimulation and poststimulation periods. Conclusions: There was successfully demonstrated the possibility to increase the LES tone. Modifications in the LES functionality and tone, during the electrical stimulation and in the period immediately after the stimulation, depend upon the pulse frequency and length. Also, the additional change of the Bluetooth transmitter antenna is necessary to offset the screening effect of the biological tissues.

Background: Recently, there was described the possibility to increase the lower esophageal sphincter (LES) tone by means of implantable electrical stimulator. Although, this method has already been used in clinical practice, however, the optimal parameters of LES electrical stimulation are still unknown. Aims: The goals of this study were to get clinical data regarding the effects of different types of electrical stimulation on LES and to elaborate and test the prototype on laboratory animals. Material and Methods: In the Department of Surgery no 4, during 4 years (2015-2018), there has been achieved one clinical-experimental study of LES electrical stimulation. During the first stage, the electrical stimulation of the LES, using an external pulse generator, was assessed in 15 patients. These patients underwent an antireflux intervention, with an additional insertion of 2 temporary electrodes on the LES. During the second stage, there was created an experimental device which consisted of a re-insertable microstimulator using wireless energy transfer. During the third stage, it was tested in the experimental surgery center "Pius Brânzeu", Timişoara, on laboratory animals (pigs). Results: Values of the LES resting pressure and integrated relaxation pressure (IRP) were significantly different during the prestimulation and poststimulation periods. Conclusions: There was successfully demonstrated the possibility to increase the LES tone. Modifications in the LES functionality and tone, during the electrical stimulation and in the period immediately after the stimulation, depend upon the pulse frequency and length. Also, the additional change of the Bluetooth transmitter antenna is necessary to offset the screening effect of the biological tissues. Recent, a fost descrisă posibilitatea creşterii tonusului sfincterului esofagian inferior (SEI) cu ajutorul unui stimulator electric implantabil. Cu toate că, această metodă a fost deja utilizată în practica clinică, totuşi, parametrii optimi ai stimulării electrice a SEI nu sunt încă elucidate. Obiectivele acestui studiu au fost obţinerea datelor clinice cu privire la efectele diferitelor tipuri de electrostimulare a SEI, precum şi elaborarea şi testarea prototipului de microstimulator implantabil şi încăcabil prin transfer de enrgie fără fir la animalele de laborator. Material şi Metode: În Departamentul de Chirurgie nr 4, pe parcursul a 4 ani (2015-2018), a fost realizat un studiu clinicoexperimental al electrostimulării sfincterului esofagian inferior. În prima etapă, stimularea electrică a SEI a fost evaluată la 15 pacienţi, utilizând un generator de impulsuri externe. Aceşti pacienţi au suferit o intervenţie chirurgicală antireflux, cu o inserţie intraoperatorie suplimentară de 2 electrozi temporari pe SEI. Pe parcursul celei de-a doua etape, a fost creat un dispozitiv experimental care a constat dintr-un microstimulator implantabil al SEI utilizând transferul de energie fără fir. În etapa a treia, acest prototip a fost testat pe animale de laborator (porci) în centrul de chirurgie experimentală „Pius Brânzeu”, Timişoara, Romania. Rezultate: Valorile presiunii de repaus SEI şi ale presiunii de relaxare integrată (IRP) au fost semnificativ diferite în perioadele de prestimulare şi poststimulare.