A New Technological Approach to Nonanatomical Pulmonary Resection: Saline Enhanced Thermal Sealing

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1 A New Technological Approach to Nonanatomical Pulmonary Resection: Saline Enhanced Thermal Sealing Anthony P. C. Yim, MD, Erino A. Rendina, MD, Stephen R. Hazelrigg, MD, Louis T. C. Chow, MD, Tai-Wai Lee, FRCS, Song Wan, MD, PhD, and Ahmed A. Arifi, MD Departments of Surgery and Anatomical and Cellular Pathology, The Chinese University of Hong Kong, Hong Kong, China, Department of Thoracic Surgery, University of Rome La Sapienza, Rome, Italy, and Department of Cardiothoracic Surgery, Southern Illinois University School of Medicine, Springfield, Illinois Background. This is the first clinical report on the feasibility study of two new devices (monopolar Floating Ball and bipolar Sealing Forceps; TissueLink Medical Inc, Dover NH) that incorporated the novel technology of saline enhanced thermal sealing. Methods. From December 2000 to December 2001, 25 patients (mean age, 54.8 years) with peripheral lung nodules planned for either diagnostic or therapeutic wedge resection were recruited for the study. When the nodule lay deep to a flat lung surface, video-assisted thoracic surgical resection using the modified Perelman technique with the Floating Ball (TissueLink Medical Inc) was preferred. In other patients, the Sealing Forceps (TissueLink Medical Inc) were used for video-assisted thoracic surgical wedge resection. Results. There were no mortality or major intraoperative complications. The Floating Ball was used exclusively in 11 patients; the Sealing Forceps were used in 9 patients; and a combination of the two devices was used in 5 patients. The mean operation time was 70.3 minutes. Average chest drain duration was 3.9 days, and postoperative hospital stay was 5.2 days. There were 2 patients with persistent air leak more than 1 week, one who resolved spontaneously, and the other who required reoperation for control. One patient had pulmonary embolism after a technically uneventful procedure. There have been no late complications after an average follow-up of 10 months. Conclusions. The devices appear to be technically safe. The Floating Ball has definite advantages over the conventional diathermy and can be adapted to the Perelman procedure using the video-assisted thoracic surgical approach. The Sealing Forceps hold promise to reduce overall consumable costs compared with conventional staplers. These devices should complement the surgeon s existing armamentarium. Comparative studies with conventional instruments are warranted to further define the role of these new devices in thoracic operations. (Ann Thorac Surg 2002;74:1671 6) 2002 by The Society of Thoracic Surgeons Diathermy (from Greek origin: dia-through, thermyheat) using the conversion of radiofrequency electrical energy to heat (to coagulate, ablate, or cut tissue) has long been accepted in almost every surgical discipline [1], including minimal access operations [2]. Bovie pioneered in its design in the late 1920s, and hence this technology came to carry its name. Diathermy as we know today, has three adjustable variables: (1) power output (rate of power delivered); (2) frequency modulation (cycles of changes of the current in 1 second), which gives the user the choice of a coagulation versus cutting mode; and (3) polarity (monopolar vs bipolar). The latter refers mainly to the distance between the electrical poles. For the monopolar mode, the second pole is the dispersive electrode plate far from the operative field, whereas for the bipolar mode, the two electrodes are only millimeters apart. For over half a century, the basic design of diathermy units has not changed. However it was recently discovered that a continuous flow of electrically conductive saline between the tissue and the diathermy electrode could result in marked changes in the coagulative property of the diathermy on living tissue [3 6]. This novel technology was incorporated in the design of two new devices: (1) a monopolar Floating Ball device (TissueLink Medical Inc, Dover NH), and (2) a bipolar Sealing Forceps (TissueLink Medical Inc, Dover NH). After initial animal studies, both devices received Food and Drug Administration 510 (k) clearance. This article is the first report of our combined initial clinical experience from Accepted for publication June 12, Address reprint requests to Dr Yim, Division of Cardiothoracic Surgery, Department of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, China; yimap@cuhk.edu.hk. Drs Yim, Rendina, and Hazelrigg disclose that they have a financial relationship with TissueLink Medical, Inc by The Society of Thoracic Surgeons /02/$22.00 Published by Elsevier Science Inc PII S (02)

2 1672 YIM ET AL Ann Thorac Surg SALINE ENHANCED THERMAL SEALING 2002;74: Table 1. Patient Demographics and Clinical Data Patient No Sex/Age Clinical Diagnoses Significant History 1 F/44 Metastatic rectal carcinoma S/P abdominoperineal resection of the rectum 2 F/46 Metastatic uterine carcinoma S/P hysterectomy 3 F/46 Metastatic nasopharyngeal carcinoma S/P chemotherapy 4 M/74 Metastatic colon carcinoma Smoker, S/P hemicolectomy 5 M/54 Giant bulla Smoker 6 M/54 Indeterminate nodule Tuberculosis, diabetes 7 M/70 Indeterminate nodule Smoker, emphysema 8 M/69 Indeterminate nodule Smoker, hypertension, diabetes 9 F/54 Metastatic carcinoma Follicular dendritic of carcinoma of the neck, S/P left lung metastatectomy 10 F/49 Indeterminate nodule 11 M/58 Indeterminate nodule Hypertension, S/P colectomy for carcinoma 12 F/65 Indeterminate nodule Gastroesophageal reflux disease, hypertension 13 M/65 Indeterminate nodule 14 M/78 Indeterminate nodule 15 M/53 Indeterminate nodule 16 F/69 Indeterminate nodule 17 F/55 Indeterminate nodule 18 F/55 Indeterminate lung nodule Diabetes mellitus, S/P thyroidectomy 19 M/53 Metastatic colon carcinoma Hypertension, S/P anterior resection 20 M/22 Metastatic teratoma Smoker, S/P orchidectomy 21 M/59 Metastatic nasopharygeal carcinoma 22 M/66 Metastatic laryngeal carcinoma Smoker, S/P ipsilateral wedge excision 23 F/43 Indeterminate lung nodule 24 M/21 Metastatic osteosarcoma S/P chemotherapy, above knee amputation 25 M/47 Indeterminate lung nodule COPD S/P status post; COPD chronic obstructive pulmonary disease; F female; M male. three centers with these first generation production devices. Material and Methods From December 2000 to December 2001, a total of 25 patients (15 males, mean age 54.8; range, 44 to 78 years) with peripheral (outer one-third) lung nodules who were planned for wedge resection were recruited for this study. Surgeons from three institutions who had experience with the video-assisted thoracic surgical (VATS) approach performed all the operations. The patients demographics and clinical diagnoses are summarized in Table 1. Ethical approval was obtained from each of the three hospitals where the procedures were carried out, and full informed consents were obtained from all patients. During the same time period, 1 patient underwent bullectomy and 3 others underwent lung fissure completion using the bipolar forceps. Because these patients did not receive nonanatomical lung biopsies, they were excluded from this report. Saline Enhanced Thermal Sealing This novel technology has been incorporated into the two new devices that provide a continuous flow of electrically conductive saline to the interface between a metal elec- Fig 1. (Left) Longitudinal section view of the Floating Ball device (TissueLink Medical, Inc, Dover, NH). (Right) Schematic diagram to show heat distribution from the device on tissue.

3 Ann Thorac Surg YIM ET AL 2002;74: SALINE ENHANCED THERMAL SEALING 1673 Fig 2. The Floating Ball device (TissueLink Medical, Inc, Dover, NH) showing its tip with a drop of saline. trode and tissue. The saline couples radiofrequency electrical energy into tissue in which it is converted into thermal energy. The flow of saline provides cooling to limit peak tissue temperatures to 100 C or less (Fig 1). This is contrary to conventional electrosurgical devices in which tissue temperature can easily exceed 300 C, resulting in tissue desiccation, char formation, smoke generation, electrodes sticking to tissue, and undesired lateral thermal damage. The new technology avoids these undesirable tissue effects, while producing the levels of tissue temperature required to achieve both hemostasis and pneumostasis of lung tissue. MONOPOLAR FLOATING BALL DEVICE. The monopolar Floating Ball device (TissueLink Medical Inc) has a 30-mm diameter spring-loaded, floating ball tip and shaft that fits through a 5-mm trocar (Fig 2). This device comes in two sizes (the endoscopic version being longer with a 32-cm shaft and a tip that has a fixed angle of 8 degrees). It is primed with saline solution from an infusion pump. There is an on-off radiofrequency activation switch (used in conjunction with a conventional electrosurgical generator like Force FX-8C, Valleylab; Tyco Healthcare, Boulder, CO) on the hand piece, and saline and electrical lines exit at its end. BIPOLAR SEALING FORCEPS. The bipolar Sealing Forceps (TissueLink Medical Inc) externally resemble an endoscopic staple-cutter (Fig 3). The device allows for simultaneous radiofrequency energy and saline to be delivered to the two jaws of bipolar electrodes for tissue coagulation. Each jaw measures 3.5 cm in length and 0.87 cm in width. The diameter of the rotatable shaft width is 1.5 cm. An internal blade could be activated by deployment of a thumb fixture on the handle to transect coagulated tissue. Radiofrequency is activated by a foot pedal from a conventional generator. Saline is infused at a rate of 8 ml/min from an infusion pump. Surgical Technique NODULECTOMY USING THE FLOATING BALL DEVICE. Under general anesthesia with selective one lung ventilation, the patients were placed in the full lateral decubitus position, prepared, and draped as for a full thoracotomy. A threeport technique, one for the thoracoscope and two for the instruments, was generally used [7]. The Floating Ball device was primed with normal saline solution from an infusion pump running at a rate of about 240 ml/h. It is also connected to a conventional electrosurgical generator (Valleylab; Tyco Healthcare, Boulder, CO) set at 40 to 50 W. A modified Perelman procedure was performed using the Floating Ball device. However, in contrast to conventional electrocautery, this device does not perforate or cut. Instead, the device was used to first coagulate and then shrink the lung tissue, to be followed by using scissors to cut into the coagulated tissue. Once the visceral pleura were incised circumferentially, the procedure could proceed fairly rapidly. A small amount of steam is usually generated during the procedure, and it is advisable to keep a sucker close to the surgical field. This can also be used to exert counter-traction on the lung tissue to facilitate dissection. This procedure was recently posted on Yim s [8] CTSNet Experts Techniques section. An alternative technique was used by one of the investigators (SRH) on patients 18 to 20 with peripheral nodules 2 cm or less in size. A side-biting clamp was placed to completely exclude the nodule, which was then excised. The cut surface on the patient s side (still held by the clamp) was painted with the Floating Ball. WEDGE RESECTION USING THE BIPOLAR SEALING FORCEPS. The intercostal strategy is exactly the same as with VATS wedge resection using a mechanical staple cutter [7]. The forceps are closed over the lung parenchyma to be divided. The device is designed to allow a continuous flow of normal saline from each jaw, so that when the electrodes are activated the current is not directly trans- Fig 3. The bipolar Sealing Forceps (TissueLink Medical, Inc, Dover, NH). The electrical and saline lines, which exit from the handle, are not shown.

4 1674 YIM ET AL Ann Thorac Surg SALINE ENHANCED THERMAL SEALING 2002;74: Fig 4. Transverse section view through the jaws of the Sealing Forceps (TissueLink Medical, Inc, Dover, NH) showing the thermal field in tissue. formed into heat energy through the tissue, but there is a saline tissue interface that provides an even energy distribution and lowers the peak tissue temperature, similar to the Floating Ball. In this early model, the electrodes need to be activated for 2 to 3 minutes to obtain the desirable coagulative effort (Fig 4). Blanching of the lung tissue next to the closed jaws is a useful indication of adequate coagulation. The coagulated lung can then be divided between the jaws using the internal blade. The generator setting is similar to that of the Floating Ball. Unlike staple transection in which the visceral pleural surfaces of the divided lung are reapproximated, there is usually a raw transected lung surface after the use of bipolar forceps. The raw surface is often completely hemostatic and pneumostatic. In those patients in which there were minor air leaks from the raw surface (on 5 occasions in this series), they were easily controlled using the Floating Ball to apply coagulation directly over the areas of air leakage. Assessment of Thermal Injury at Resection Margin The resected specimens were carefully studied to assess thermal injury at the resection margin. The specimens were fixed in 10% buffered neutral formalin. The resection margins were inked with Alcian blue. The specimens were then serially sectioned and processed in the usual way for paraffin embedding slides (4 m in thickness) and prepared and stained with hematoxylin and eosin, as well as elastin van Gieson s. Then a senior histopathologist carefully examined the slides, and the depth of thermal injury from the margin was measured. For each slide, the maximal and minimal depths of injury were recorded. Results There was no mortality. The operative procedures and postoperative course of the patients are summarized in Table 2. In 11 patients, the Floating Ball alone was used for resection. The Sealing Forceps were used in the remaining 14 patients in whom the Floating Ball was used also in 5 patients to control minor air leaks. The overall mean operation time (excluding 3 patients of completion lobectomies, patients 11, 14, and 21) was 70.3 minutes (range, 38 to 122 min). Average chest drain duration was 3.9 days (range, 1 to 15 days) and postoperative hospital stay was 5.2 days (range, 1 to 16 days). Minor bleeding was encountered in our early experience in 3 patients (2 with the Sealing Forceps [patients 2 and 6], and 1 with the Floating Ball [patient 3]) when the vessels were transected before they were adequately coagulated. This was promptly taken care of by endoscopic suturing without difficulty. Four patients had one of the port sites converted to a limited thoractomy (3 patients for completion lobectomy when the frozen section report of the excised nodule came back as nonsmall cell lung cancer [patients 11, 14, and 21] and 1 patient because of our inability to identify a small [0.5 cm] peripheral nodule thoracoscopically [patient 8]). There were 2 patients with persistent air leaks of more than 1 week. Patient 6 had an air leak that resolved on its own; this patient s chest drain was removed on postoperative day 10 without requiring further intervention. Patient 24 required reoperation on postoperative day 12 for control of a persistent air leak from a small raw lung surface that was excised. Also, patient 10 had a pulmonary embolism after a technically uneventful procedure. This patient was administered anticoagulation medication, was discharged on postoperative day 10, and had no further complications. We believe this patient s events were unrelated to the procedure. We have not encountered any patient with postoperative wound infection, pneumonia, or dysrhythmia. Pain medication requirements seemed to be similar to the other patients who underwent the VATS approach using conventional devices (stapler or suturing). There have been no late complications after an average follow-up of 10 months. When the resected margin of the specimen was carefully examined for depth of thermal injury by microscope, the thermal spread averaged 2.5 mm (range, 2.2 to 3.6 mm). There was no difference in the depth of coagulative necrosis between the Floating Ball device or the Sealing Forceps. Comment Nonanatomical pulmonary resection is commonly indicated for diagnostic or therapeutic purposes. The surgical approaches and techniques for this procedure have evolved for many years. Before the advent of mechanical staplers, the prevailing technique for resection of a peripherally located pulmonary nodule was to clamp, cut, and sew. Straight hemostatic clamps were placed around the nodule with at least a 2-cm margin. The specimen

5 Ann Thorac Surg YIM ET AL 2002;74: SALINE ENHANCED THERMAL SEALING 1675 Table 2. Operative Procedures and Postoperative Course Patient No. Location/ Size (cm) Device Additional Procedure Operating Room time (mins) Chest Drainage (days) Postoperative Hospital Stay (days) 1 LUL (1) Forceps RML (1.5) Forceps Suture LLL (1.5) Ball Suture RUL (1) Forceps LUL (3) Forceps & Ball RUL (1.5) Forceps Suture RML (1.5) Forceps & Ball RLL (0.5) Ball Conversion to mini-thoracotomy RML (2) Ball LLL (2) Ball RLL (3) Forceps Completion lobectomy LUL (1.5) Ball RUL (1) Ball LUL (3.5) Ball Completion lobectomy RUL (1) Ball LUL (2) Ball LUL (4) Ball RLL (1.8) Ball RUL (2) Forceps RUL (1.2) Forceps RUL (2.6) Forceps & Ball Completion lobectomy RLL (3) Forceps & Ball No LLL (0.8) Forceps No LLL (0.8) a Forceps & Ball No LLL (1) Forceps No a Required second operation on postoperative day 12 to control persistent airleak. LLL left lower lobe; LUL left upper lobe; RLL right lower lobe; RML right middle lobe; RUL right upper lobe. was removed by shaving it off the clamp, and the raw surface reapproximated by a running horizontal mattress suture and reinforced by a simple over-and-over running suture of nonabsorbable, monofilament material. This was satisfactory for small nodules, especially those located near the free edge of the lung. Mechanical staplers simplified the technique by combining all three maneuvers of clamp, cut, and sew into one movement. The advent of the VATS approach soon became the method of choice in many thoracic centers worldwide. One remaining concern was the high cost of consumables in developing countries. On the other hand, for larger nodules ( 2 cm) and especially those lying deep to a flat lung surface, wedge resection using this technique is often difficult or even hazardous. Even if this could be done, it would almost certainly sacrifice more functional lung tissue than would be necessary or desirable. This could have a major impact on the recovery of patients who are elderly, and frail, with multiple comorbidities and borderline lung function. A solution was offered more than 20 years ago by the Russian surgeon, Dr Mikhail Perelman used electrocautery to achieve precise, nonanatomical lung resectionthis technique was subsequently popularized by Dr Joel Cooper [9]. However, this precision cautery excision, as it is often referred to, is not ideally suitable for the VATS approach. This technique requires the lung to be in an inflated state. Because electrocautery is often required to be turned up to a high setting, there is a moderate amount of smoke generation and charred tissue sticking to the electrode, which demands frequent cleaning. Finally, because the electrode can perforate a moderatesized blood vessel (3-mm diameter or larger) before it gets coagulated, bleeding could be troublesome and difficult to control thoracoscopically. Landreneau and colleagues [10] more recently advocated the use of the neodymium:yttrium-aluminum garnet laser, either alone or in combination with the mechanical stapler, to approach difficult nonanatomical resections using the VATS approach. The advantage of the laser appears to be its ability to achieve better hemostasis compared with electrocautery. However, the high initial cost for set up, coupled with the stringent safety requirements have deterred many surgeons from using this method. The Floating Ball device described here has the ability to achieve good hemostasis (as it does not perforate vessels) without the high initial cost. However, like other new techniques and technology, there is an initial steep learning curve for the surgeon. As the surgeon is required to individually divide the coagulated vessels and bronchioles, more time has to be allowed for this proce-

6 1676 YIM ET AL Ann Thorac Surg SALINE ENHANCED THERMAL SEALING 2002;74: dure compared with the conventional electrocautery procedure. Also, as the operated lung is deflated, there is a tendency that the surgeon could remove more functional lung tissue than would be necessary or desirable. However, this can be overcome by experience. Also, pathologic interpretation of the resection margin is not a concern as we have shown that the depth of coagulative necrosis caused by thermal spread averaged only slightly more than 2 mm. This in fact compared favorably with the conventional technique using the staplers, which would require the staples to be removed (averaged more than 2 mm in depth) before sectioning can be done on the specimen. With regard to the bipolar Sealing Forceps, it would be difficult to find a niche application similar to that of the Floating Ball device. The staplers, because of the speed, reliability, and ease in using this device remains the current gold standard for both wedge lung resections and comparisons made with other newer devices. However, reloadable cartridges for the staplers are expensive, and in developing countries, the high consumable costs could be a major deterrent to its use [11]. On the other hand, bipolar forceps hold promise to minimize consumable costs. These new devices are not meant to replace conventional diathermy, but rather complement the surgeon s existing armamentarium. In conclusion, this article represents the first detailed written report on the clinical application of a novel technology for lung operations. The devices appear to be technically safe. Nodulectomies performed using the monopolar Floating Ball device produce satisfactory results, with some added advantages over the conventional diathermy, including that the former could easily be adapted for the VATS approach. Peripheral wedge lung resections using the bipolar Sealing Forceps are technically feasible. The sealing forceps used in our study was from the first generation, and with further refinement, it holds promise to be an attractive alternative to staplers. The authors are grateful to Mr Michael McClurken for his help with Figures 1 and 4. References 1. Memon MA. Surgical diathermy. Br J Hosp Med 1994;52: McAnena OJ, Willson PD. Br J Surg 1993;80: Patel VP, Leveille RJ, Hoey MF, et al. Radiofrequency ablation of rabbit kidney using liquid electrode: acute and chronic observations. J Endourol 2000;14: Miao Y, Ni Y, Mulier S, Wang K, Hoey MF, et al. Ex vivo experiment on radiofrequency liver ablation with saline infusion through a screw-tip cannulated electrode. J Surg Res 1997;71: Liem LB, Pomeranz M, Riseling K, et al. Electrophysiological correlates of transmural linear ablation. PACE 2000;23: Hoey MF, Dixon CM, Paul S. Transurethral prostate ablation using saline-liquid electrode introduced via flexible cystoscope. J Endourol 1998;12: Lin JC, Landreneau RJ. Strategic planning for video-assisted thoracic surgery. In: Yim APC, Hazelrigg SR, Izzat MB, et al, eds. Minimal access cardiothoracic surgery. Philadelphia: WB Saunders, 2000: Yim APC. New technological approach to pulmonary nodulectomy General Thoracic Experts Techniques Cooper JD, Perelman M, Todd TR, et al. Precision cautery excision of pulmonary lesions. Ann Thorac Surg 1986;41: Landreneau RJ, Keenan RJ, Hazelrigg SR, et al. VATS wedge resection of the lung using the neodymium:yttriumaluminum garnet laser. Ann Thorac Surg 1993;56: Yim APC. Cost containment strategies in video assisted thoracoscopic surgery an Asian perspective. Surg Endosc 1996;10: