REFERANSLAR

New York, NY, 11 July 2007
Our reference: ATS 19090
Editorial reference: ATS/2007/145516
Re: A NEW ENDOLUMINAL RESECTION TECHNIQUE AND DEVICE: RESECTOR BALLOON
To be published in: The Annals of Thoracic Surgery

A NEW ENDOLUMINAL RESECTION TECHNIQUE AND DEVICE: RESECTOR BALLOONYalcin Karakoca, MD, Proff 1, Guler Karaagac , MD1, Cuneyt Aydemir, MD2, Cevdet Caner, MD3INTRODUCTION: Endoluminal resection techniques have become an increasingly accepted method of palliation for patients with endoluminal tumoral lesions in central airways (1). The management requires palliative procedures approximately in 90 % of the advanced lung cancer cases (1, 2). Main bronchi are obstructed in half of the cases. Autopsy studies show that endoluminal tumors cause death in 75 % of epidermoid carcinomas and 50 % of adenocarcinomas (3).

Therapeutic bronchoscopic procedures (laser, cautery, argon, cryo, stent implantation and balloon dilatation etc.) are used in combination with each other according to the location and type of the lesion. This can be done either through rigid bronchoscope or by flexible bronchoscope which is more widely used (2, 4, 5). Although 90 % of lung cancer patients need palliative treatments, interventional bronchoscopy techniques are not used to their full potential.

Dyspnea, post-obstructive pneumonia and haemoptysis are the main symptoms of advanced lung cancer. Therapeutic bronchoscopy can provide immediate relief from dyspnea and haemoptysis faster than radiation and chemotherapy. In advanced cases if we start by using endobronchial techniques initially, time can be gained for other treatment modalities with higher quality of life and less complication (6). During the endobronchial treatment balloon application is mainly used to dilate bronchi or control bleeding (4, 7, and 8). However it is also possible to use a modified balloon as a resection tool with dilatation and tamponade capabilities.MATERIAL AND METHODS: Informed consent was obtained from each patient before the procedure and this study was approved by our Institutional Ethics Committee.“Resector balloon” is composed of a 120 cm long single lumen polyethylene tube of 2 mm outer diameter. On its distal end a latex balloon is mounted. The length of the balloon is 10 mm, 20 mm and 40 mm for 3 different types. The maximum inflated diameter of the balloon is 10mm, 15 mm and 20 mm consecutively. The balloon is covered with a hexagonal mesh structure made of 0.3 mm thick polyurethane fibers.

The minimum deflated balloon diameter with the mesh structure on it is 3 mm for all types. When inflated just at the level of endoluminal tumor the polyurethane fibers around the balloon cuts and destructs the tumoral tissue. At the same time the balloon makes a compression on the tumor to minimize the bleeding. So the “resector balloon”, when inflated endoluminally, can be used to destruct mechanically and remove tissues from lesions filling the bronchial lumen. (Figure I-II)

In this technique, the balloon is placed into the bronchial lumen where the tumor overlays the deflated balloon. The balloon is repeatedly inflated until the interior surface of the lumen is in complete contact with the balloon’s surface and deflated until the tumor tissue is completely flattened out or torn down. This causes destruction in the tumor tissue. If necessary the resector balloon is introduced further the procedure is repeated until the tumoral tissue is destructed and then the resector balloon is moved to-and-fro to resect pieces from the tumor. The pieces are then aspirated or taken out by using forceps. Same procedure is repeated until the lumen patency is established. Any possible bleeding can also be controlled simultaneously by balloon tamponade, the balloon is already in the lumen and the bleeding is prevented.Between April and December 2006, 30 patients (21 men and 9 women; age range, 19 to 71years; mean age 54 years) with tracheobronchial obstruction due to malignancy (n= 29), and granulation tissue (n=1) were admitted to our clinic. The symptoms included dyspnea, stridor, fever, respiratory insufficiency, haemoptysis, in combination with rise of white blood cell count, C-reactive protein due to post obstructive pneumonia.

Diagnosis established by reviewing patient’s history, computerized tomography (three dimensional reconstructions) and bronchoscopy. Except one male patient with PITS, previously chemoradiotherapy were given all of malignant cases. Patient demographics are summarized in Table 1.Prior to the operation, all patients were evaluated by cardiologist and anesthesiologist, premedicated and were given antibiotics. Interventions were performed under general anesthesia via rigid and flexible bronchoscopes. We used Dumon-Harrel Rigid Bronchoscope and Olympus Therapeutic Bronchoscope BF-XT-40 which has 3.2mm channel diameter. YAP-laser, cryotherapy, stenting also were performed-when required.

We used resector balloon in 38 interventions in 30 cases which had endoluminal and submural tumoral invasion at proximal trachea in 1, distal trachea in 4, carina 3, left main bronchus in 8, left lower bronchus in 5, left upper bronchus in 5, left lower segment bronchus in 1, right main bronchus in 11, right upper bronchus in 3, right intermediate bronchus in 3, right middle lobe bronchus in 1, right intermediate bronchus in 4, right lower bronchus in 4 cases. In 28 of interventions, endoluminal tumors were completely resected by resector balloon alone. In 10 interventions resector balloon used with other endobronchial techniques, laser and cryotherapy. The main limiting factor is tissue density. If the tumor tissue is hard (not enough fragile to destruct with resector balloon) we needed YAP laser coagulation and vaporization effect. Also we use cryotherapy mainly as forceps.

RESULTS: In such lesions endoluminal resection, dilatation and bleeding control can be achieved all together with “resector balloon’’. We used resector balloon in 38 interventions. In 28 of interventions, endoluminal tumors were completely resected by resector balloon alone. In the remaining 10 interventions resector balloon and other endobronchial techniques were used. In the literature we couldn’t find any publication in which the balloons were used for resecting purposes.However, balloon catheters are frequently used in bronchoscopy for bleeding control and dilatation (2, 4, 7, 8, and 10). Exophytic tumor growth is the indication for cutting techniques. Mechanical resection with rigid bronchoscope may cause heavy bleeding from the vascularised tumor. Nd YAG laser is the most commonly used method of endobronchial tumor resection (9, 10).

The clinical benefit of a laser tumor resection is high in trachea, main bronchus and lobar bronchus. “Resector balloon” which we developed for resecting endoluminal lesions is composed of various sizes of balloon catheters covered with a special web-shaped material. Because of the balloon tamponade effect dilatation and bleeding control can also be achieved with “resector balloon”. We have no bleeding complications which continue after tumor resection and dilatation of the obstructed bronchus. We used resector balloon alone and together with laser and cryotherapy. Because there are some lesions you may lose the control while using laser or electrocautery, and usually if it is not possible to apply laser coagulation or vaporization in 360? circumference position. Resector balloon make it easily possible because working in a cylindrical anatomic position with a cylindrical resector device.

The significance of therapeutic bronchoscopy increases and is more widely used in the world. New generations of radiotherapy and oncological treatment modalities has a better impact on the prognosis of lung cancer. As the airway obstruction is cleared, better oxygenisation may be obtained and the possibility of resistant lung infections can be avoided. This of course will yield to further radiotherapeutic or oncological treatments with higher survival rate and better quality of life (2, 9).

COMMENT: The major limiting factors in endobronchial therapy are the location of the tumor, the type of its invasion, complication risk of resection methods and operation time. It is quite easy to perform laser, cautery and cryo in large airways such as trachea and main bronchi. Risk of complication increases when the tumor is located more distally (6, 7, 9,). Prior to resector balloon it was difficult to handle upper lobar bronchi lesions. Resector balloon introduced through flexible bronchoscope is now easily used to open upper lobar and distal airways. In these locations, it was nearly impossible to achieve complete endoluminal resection due to high risk of complications of laser, cautery, argon, cryo and mechanical resection (4, 5). determined that the duration of intervention was much less. The operation time is at least 50% reduced. The anesthesia time is reduced and the complication ratio due to anesthesia is reduced. Due to resector balloon tamponade, laser was used rarely; therefore toxic hot gas inhalation and the other laser risks were reduced.

After using this technique we didn’t need laser or the other hot coagulation and vaporization techniques as we need before. And the need for photodynamic therapy is reduced because of the cylindrical shaped resector technique. The tip of the rigid bronchoscope is known to be responsible for complications when used for mechanical resection which may cause bleeding and destruction of normal bronchial cartilage (9).Resector balloon is very gentle and only removes the endoluminal tumors. Complications such as heavy bleeding, cartilage destruction and perforation are not observed. In 28 interventions only resector balloon was used as a unique resection technique and no other additional technique was necessary. In three cases the resections were done in two sessions and in one case five resection sessions were done. In three cases resections were done in two sessions because of tumor regrowth after three months. The five sessions made patient was a metastatic pancreatic tumor and nearly all of the segment bronchi were obstructed with endoluminal tumor and the general status was very poor. She was entubated because of insufficiency and died one month later in hospital. For the upper lobar and segmental lobar lesions we used resector balloon via flexible bronchoscope.In the literature we couldn’t find any publication in which the balloons were used for resecting purposes. Before we use the resector balloon method, balloons were used for bleeding control and dilatation (2, 4, 7, 8, and 10). Using resector balloon in endoluminal lesions for resection, dilatation and tamponade is considered as easy, reliable and effective.

DISCLOSURES AND FREEDOM OF INVESTIGATIONNo financial support was received for this study and the equipment used has not been donated for the purposes of this study. The authors had full control of the study design, the methods used, and outcome parameters, analysis of the data and production of this report.

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