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Interact CardioVasc Thorac Surg 2009;8:615-618. doi:10.1510/icvts.2008.200584 © 2009 European Association of Cardio-Thoracic Surgery
Clinical application of an ultrasonic scalpel to divide pulmonary vessels based on laboratory evidenceDepartment of Surgery and Clinical Science, Division of Chest Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-kogushi, Ube, Yamaguchi 755-8505, Japan Received 9 December 2008; received in revised form 23 February 2009; accepted 24 February 2009
*Corresponding author. Tel.: +81-836-22-2261; fax: +81-836-22-2423.
The Harmonic Ace ultrasonic scalpel (Ethicon Endo-Surgery, Inc, Cincinnati, Ohio), has been widely used in endoscopic surgery to divide systemic vessels, but not pulmonary vessels. We describe our initial clinical experience of using it for pulmonary vessel division. The Harmonic Ace was used to divide pulmonary vessels 5 mm or less in diameter, secured with a proximal single ligation, in 20 patients who underwent video-assisted major lung resection between September 2007 and April 2008. We also evaluated the sealing potential of this device in a pig model. We divided 43 pulmonary arteries and 13 pulmonary veins (PV) by the device. The diameter of the divided vessels ranged from 2 to 5 mm. Vascular sealing was successful in all except two early procedures: several subsegmental arteries were held at once, and vessels positioned near the distal end of the blade jaw bled intraoperatively. There was no postoperative bleeding. In the pig model, the bursting pressure of sealed pulmonary arteries (PA) was >75 mmHg. Pulmonary vessels can be safely divided using the Harmonic Ace with proximal single ligation unless multiple or large pulmonary vessels are held within the blade jaw.
Key Words: VATS; Ultrasonic scalpels; Pulmonary vessels; Division
Video-assisted thoracic surgery (VATS) has become an acceptable technique for the resection of early-stage lung cancer, as it has achieved excellent long-term outcomes [1, 2]. However, there are some technical difficulties associated with division of the pulmonary vessels during VATS major lung resection, which often requires conversion to open thoracotomy. The Harmonic Ace (Ethicon Endo-Surgery, Inc, Cincinnati, Ohio) ultrasonic scalpel has been used clinically for the division of systemic vessels. The device has a small narrow blade jaw, and seems to be useful for dividing pulmonary vessels. Nicastri et al. reported that the Harmonic Ace proved reliable for dividing pulmonary vessels 4 mm or less in diameter in an animal model [3]. However, there is no report on this device being used to divide pulmonary vessels clinically, even though the Food and Drug Administration of the Unite States Department of Health and Human Services (FDA) has approved its use for dividing any vessels 5 mm or less in diameter. We discuss the pros and cons of the Harmonic Ace for dividing pulmonary vessels based on the findings of our initial study on patients undergoing VATS major lung resection.
2.1. Experimental study 2.1.1. Animals This study was approved by the Institutional Animal Care and Use Committee. We performed right lung lobectomy on two female pigs aged three months.
2.1.2. Operation, pulmonary artery division and pressure measurement This study was approved by the Institutional Review Board of the Yamaguchi University School of Medicine. Consent for the study was waived. The subjects were 20 patients who underwent VATS major lung resection with the aid of the Harmonic Ace between September 2007 and July 2008. The patient characteristics are summarized in Table 1.
2.2.2. Procedure VATS was performed via three access incisions: pure-VATS was performed via one small lateral thoracotomy (2–4 cm) and two 1.5 cm incisions, whereas hybrid-VATS was performed via one small lateral thoracotomy (6–8 cm) and two 1.5 cm incisions. All pulmonary vessels were divided at the segmental or subsegmental branches. Pulmonary vessels 5 mm or less in diameter were divided by the Harmonic Ace after being secured by a single proximal ligation, and vessels >5 mm in diameter were divided by an endostapler.
2.2.3. Ultrasonic scalpel, Harmonic Ace
In the animal experiments, intraoperative division of the PA was successful and there was no intraoperative hemorrhage. The bursting pressure was over 100 mmHg in all PA stumps except for one branch, which ruptured at 75 mmHg. This branch had been held at the tip of the blade jaw. In the patients, 43 branches of the pulmonary artery (PA) and 13 branches of the pulmonary vein (PV) were divided by using the device. The resected stump of the PA branch bled in two early patients. The first patient underwent middle lobectomy via hybrid-VATS. The A4 branch was exposed and ligated, followed by division using the Harmonic Ace. Because the A4 was short, the Harmonic Ace was used to divide three subsegmental arteries (A4a, A4b and A4c) at once. Bleeding occurred from the resected side of the subsegmental artery that was positioned at the distal end of the blade during division (Fig. 2). The second patient underwent left upper lobectomy via pure-VATS. The A4+5 branch was ligated followed by division with the Harmonic Ace. Because the A4+5 was also short, the Harmonic Ace was used to divide two subsegmental arteries at once. Likewise, bleeding occurred from the resected side of the subsegmental artery, which was positioned at the distal end of the blade during division (Fig. 3a,b). There was no intraoperative or postoperative bleeding in any other patients.
Histological examination revealed degeneration of the collagen and elastic fibers and tight sealing at the resected stump of the PA (Fig. 4a,b).
VATS lobectomy has been widely accepted for the resection of early-stage lung cancer [1, 2]. Although the complication rate after VATS major lung resection is low, life-threatening bleeding can occur if the pulmonary vessels are injured. Traditionally, pulmonary vessels have been divided with an endostapler or by double ligation after enough exposure of the vessels. However, it is sometimes difficult to expose the pulmonary vessels adequately because of chronic inflammation, adhesion with silicotic lymphnodes, or tumor invasion of the pulmonary vessels. Limited access to the port site also makes it difficult to insert stapling devices to divide pulmonary vessels. The Harmonic Ace has been used for dividing systemic vessels in laparoscopic surgery [4]. The greatest advantage of the Harmonic Ace Pistol Grip for VATS major lung resection is that it has a narrow shaft and a narrower and more curved blade than other sealing devices. Therefore, it can be used more safely and comfortably than other sealing devices for dividing the pulmonary vessels, despite which, there is no published report on its clinical use even though it is FDA approved. Nicastri et al. found the Harmonic Ace a reliable device to divide pulmonary vessels 4 mm or less in diameter in a pig model [3], but concluded that further examination of the device's limitations was necessary for clinical use. Therefore, we attempted to use the Harmonic Ace for dividing the pulmonary vessels with single ligation on the proximal side. Bleeding from the resected side of the PA branch occurred in two patients early in this series. In both patients, it was the vessels that had been positioned at the tip of the blade during division that bled (Fig. 3b). The Harmonic Ace achieves successful vascular sealing and cutting when the vessels are closed by the blade with considerable power. When multiple vessels or a large vessel are held at once, the closing force on the vessels positioned at the tip side is reduced. This reduced closing force might have contri- buted to the incomplete vascular sealing. The thin vascular wall in the PA may also be affected by this reduced closing force. Although these speculations need to be proved in the next animal model, we recommend that multiple vessels should never be divided at once, but be divided individually. After we noted these possibilities, there were no further cases of incomplete sealing. In the experimental study, the Harmonic Ace achieved sufficient sealing of the PA to >100 mmHg, as evaluated by a stepwise pressure elevation test, except for one vessel which ruptured at 75 mmHg. It is noteworthy that this vessel had been sealed at the distal site of the blade; however, we must keep in mind that intraoperative manipulations, such as touching or pulling the sealed vessel stump to obtain a surgical view, could cause rupture of the sealed vessels. The histological findings indicated that collagen and elastic fiber had degenerated and were sealed tightly at the stump of the PA branch. However, the length of the sealing was approximately only 0.7 mm because of the narrow blade. The strength of the stump is still controversial. Campagnacci et al. [5] reported that the electrothermal bipolar was more effective than the ultrasonic scalpel with less blood loss in laparoscopic colorectal operations. On the other hand, Newcomb et al. [6] reported that the ultrasonic scalpel had minimum seal failure in laparoscopic surgery. From these reports, although the pressure of the pulmonary circulation is lower than that of the systemic circulation and the strength of sealing may be adequate based on clinical and pathological findings, we recommend that proximal single ligation of each branch be done to allow safe division of the pulmonary vessels. The present study in the clinical setting has focused on the feasibility of the Harmonic Ace in dividing pulmonary vessels. Despite the excellent outcome of the present study, we must always keep in mind that the active blade of the device should be apart from any neighboring vital structures during the sealing because Yamada et al. have alerted the potential of serious injury by the active blade in an animal model [7]. Beside the feasibility study, we must further clarify the impact of using this costly device on the clinical outcome, such as procedure-related time, overall operation time, and the amount of intraoperative bleeding, by comparing with control subjects. We must also clarify the utility of this device during the lymph node dissection and even during the dissection of incomplete fissure.
The most important considerations in our initial experience for the safe and effective use of the Harmonic Ace are the diameter of the vessel and the position of the vessel on the blade jaw after grasping it. This device would aid video-assisted major lung resection surgery because it requires proximal ligation alone to divide the pulmonary vessels.
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Abstract
1. Introduction
