ProductsBET - Balloon Eustachian Tuboplasty

Bielefeld Balloon Catheter

Obstructive tube dysfunction often involves a chronic functional defect in which the regular aeration and ventilation as well as the self-cleaning capability of the middle ear are limited. The consequences of this malfunction include the development of chronic otitis media which, in the worst case, may lead to the destruction of the middle ear structures, resulting in subsequent hearing loss.

“The introduction of microsurgical and endoscopic techniques revolutionized medicine and is still state of the art today.
The development of balloon catheters used, for example, in the dilatation of coronary arteries led to revolutionary treatment concepts, previously deemed unthinkable.
Transferring this technology to the dilatation of the Eustachian tube enables conservative causative treatment of chronic middle ear
inflammation for the first time ever and paves the way for further treatment options, particularly for chronic tube malfunction and established middle ear pathologies.”
(Prof. Dr. Holger Sudhoff)

In a practical clinical study, Professor Holger Sudhoff has proved that the Eustachian tube can be treated by means of a modified PTA catheter which is introduced into the tube with the aid of a special microendoscope specifi cally developed for this purpose. The microendoscope is constructed in such a way that the catheter may be advanced into the tube in a carefully controlled manner without injuring any critical structures. This minimally invasive procedure is extremely gentle on the patient.

A preoperative tubomanometry (TMM) is performed on the patients for a detailed assessment of tube function and in order to decide whether dilatation should be performed.

The treatment principle is similar to that of balloon dilation in vascular stenosis and has recently also been established in the treatment of chronic obstructive sinusitis. Studies on balloon sinuplasty have shown it to be a safe and reliable treatment procedure.

 Prof. Dr. med. Holger Sudhoff Chefarzt der HNO-Klinik, Klinikum Bielefeld
Prof. Dr. Holger Sudhoff, M.D., head physician, ENT clinic, Bielefeld

An experimental investigation was initially performed on cadavers to develop and test the technical procedures of such an intervention. Thereafter, histological examinations were performed on the petrosal bone to record the direct effects that balloon dilation has on the Eustachian tube and its surrounding structures.

During the clinical part of the study, balloon dilation was performed on subjects with obstructive tube dysfunction. The functional outcome was statistically analysed. A clinical prospective study concept was developed and put into practice.

First of all, under transnasal endoscopic vision of the lateral wall of the epipharynx, a suitably modifi ed catheter is placed adjacent to the pharyngeal ostium of the Eustachian tube. This catheter, with a balloon at its distal tip, is pushed through the working channel of the microendoscope and carefully advanced into the tube while avoiding any resistance. Once the balloon is positioned inside the tube, a saline solution is used to apply the dilation up to a pressure of 10 bar. Pressure is maintained for 2 minutes. Then the solution is aspirated from the balloon and the catheter is carefully removed with the endoscope to complete the procedure.

In order to investigate the functional changes of Eustachian tube dilation by balloon catheter, the intervention was performed on a total of eight patients (aged 20 and above) treating a total of 13 ears. Pre and postoperative results were compared using a specially developed Eustachian tube score (ETS) of subjective and objective parameters. Follow-up examinations were performed after one, two and eight weeks. Only patients with chronic obstructive Eustachian tube dysfunction were included in the study. The Eustachian tube score showed a signifi cant improvement in tube function in the clinical part of the study. There were no intra or post-operative complications.

The success of other treatment procedures was mainly assessed using examination methods that only allowed indirect conclusions regarding tube function. This study, however, used tubomanometry as a method of directly measuring tube function by assessing the tube‘s gas transfer capability. Two months after the treatment, ten cases showed evidence of tube opening in all three TMM measurements (30, 40, 50 millibar). Three cases showed tube opening in two of the three measurements. There was not a single case where tube opening did not occur in one of the three measurements.

Tube opening

The results of this study show that dilation of the Eustachian tube is a safe and uncomplicated procedure. It appears to be a good treatment option to improve obstructive tube dysfunction.

Please be aware that so far there has not been suffi cient experience in the treatment of patients under 20 years of age.

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