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Endoscopic Platforms for NOTES
Pankaj J. Pasricha & Homero Rivas
Stanford University School of Medicine, Stanford, CA, USA
Introduction
Natural orifi ce translumenal endoscopic surgery (NOTES) represents a potentially signifi cant breakthrough and a para­digm shift in surgery. The adoption of this concept was the result of the work of a multicenter team of investigators (the Apollo Group) in the late 1990s [1–4]. Since then, numer­ous technological advances have been created and imple­mented in many different areas of interventional endoscopy and minimal -access surgery while trying to promote NOTES as a sole technique.
As with any technological or technical innovation, propo­nents of NOTES need to demonstrate how this technique can be practically implemented, and whether its effi cacy, risks, and costs are comparable or better as compared with the current standards of practice. Only then can we expect it to cross the chasm from concept to reality and be widely adopted. Indeed, during the fi rst decade of NOTES, some critics have said that the approach has fallen short of its expectations [5]. On the other hand, many clinicians and innovators have argued the opposite, as numerous endo­scopic platforms have been created and successfully imple­mented as a result of extensive multidisciplinary work in this fi eld throughout the world [1,6,7].
These endoscopic platforms have been tailored to all dif­ferent potential points of entry access through natural ori­fi ces (i.e., mouth, rectum, vagina, etc.) [8–11]. In addition, some platforms have been designed for hybrid surgical and endoscopic approaches leveraging on single -port laparos­copy and also on the use of microscopic laparoscopic instru­mentation (MAN -OS) [12].
Critical features of an ideal NOTES platform
There are four fundamental requirements for a NOTES plat­form [4]:
1 Provide safe entry into the peritoneal cavity. 2 Provide a stable conduit for rapid passage of instrumenta-
tions, including imaging and therapeutic tools.
3 Maintain safe peritoneal distention. 4 Provide quick, easy, and robust closure of the visceral
defect at the end of the procedure.
Safe access entry
In general, two of the most important technical features that any ideal NOTES platform should include are the safe crea­tion of a translumenal access and its reliable and easy closure at the end of the procedure. For most clinical applications, such points of access include the proximal or distal gastroin­testinal (GI) tract or through the vagina. Additionally, and perhaps just as importantly, such platforms should be stable and may allow use and change of endoscopic instrumenta­tion (including advanced energy, retraction, and suturing devices) while providing superb optics and excellent access and visualization of intra -abdominal structures (Table 2.1). Ideally, all of these features would be easy to master, espe­cially by average endoscopists.
Provision of safe entry to the peritoneal cavity from a visceral organ is not necessarily a straightforward task. The most important complication to avoid during this phase is damage to neighboring organs, and several techniques have been used to deal with this, including the use of a percuta-
Natural Orifi ce Translumenal Endoscopic Surgery (NOTES): Textbook and Video Atlas, First Edition. Edited by Anthony N. Kalloo, Jacques Marescaux,
Ricardo Zorron.
© 2012 John Wiley & Sons, Ltd. Published 2012 by John Wiley & Sons, Ltd.
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CHAPTER 2 Endoscopic Platforms for NOTES
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Table 2.1 Features of an ideal NOTES platform.
Three -star features (essential)
• Triangulation
• Instrument able to cover the operative fi eld
• Precise and smooth control
• High fl ow regulated insuffl ations
• Good suction and irrigation
• Vigorous retraction
Two -star features (ideal but not absolutely essential)
• Automated imaging
• Complete array of dedicated tools
• Accessory design that is uniform across vendor supply
One-star features (nice to have but not essential)
• Seated interface
• Voice activation
• Multiple optical views
• Wireless operation
• Mobility
• Cost effective
neous endoscopic gastrostomy -like approach [13]. Perhaps one of the most intuitive forms of safe access, and the one frequently used clinically in the GI tract, has been to create a submucosal tunnel, as was fi rst described by Sumiyama and colleagues from the Apollo Group [14]. This provides a long submucosal fl ap, which allows entry into the abdomen while providing an additional defense mechanism against a leak once the conduit is no longer needed. Inoue et al. have successfully implemented this technique in a modifi ed way during their per -oral endoscopic myotomy for achalasia (POEM) [15,16]. While Inoue ’s technique is not translume­nal, it follows the same endoscopic paradigm shift of NOTES. Other forms of direct transvisceral access without this sub­mucosal fl ap would rely on a primary closure by a number of different devices, as described later in this chapter.
Stable platform
Attaining a stable platform for access via the GI tract almost invariably will require the use of an overtube. This would provide rigidity to the endoscope and facilitate scope exchanges. Further, additional functionality necessary for the procedure (such as closure) could be incorporated into the design of the overtube instead of the endoscope. In the case of transvaginal NOTES, such an overtube is repre­sented by either a modifi ed laparoscopic port or one with multiple working channels in addition to an optical one. Occasionally, such an overtube may not be needed, and only a simple plastic cap at the end of the endoscope may be suf­fi cient to allow creation of submucosal fl aps, use of closure devices, etc.
Peritoneal distention, optimal optics, and extensive access throughout the abdomen
The techniques of intraperitoneal fl exible endoscopy are even more demanding than the intralumenal approach, especially when multi -quadrant evaluations of the abdomen are required. Maintaining orientation and a sense of direc­tion is essential as the visualization of the surgical horizon usually is dramatically different than that obtained in con­ventional laparoscopic surgery. Some platforms, especially those used for transvaginal access, have mainly relied on rigid endoscopy, attenuating some of these issues. However, fl exible endoscopic platforms provide better access to more locations in the abdomen in comparison to rigid endoscopy and will probably become the norm if NOTES becomes widely adopted.
Distention of the peritoneum will probably be important for many NOTES procedures and ideally will be done using an inert gas such as carbon dioxide that is easily absorbed after the procedure. However, overinfl ation presents its own problems with respect to diaphragmatic and respiratory mechanics, and intraperitoneal pressures will need to be monitored and regulated [17].
Safe and reliable closure of access entry
One of the most crucial factors for the success of the NOTES technique is the safe closure of the site of peritoneal entry at the end of the procedure. Presently there are already multiple platforms that allow this, and while they are not used daily in NOTES they are certainly employed safely and successfully in clinical practice for other indications. These include clips, clasps, full -thickness sutures, T -bars, etc. Ideally, these closure mechanisms should be automated and/ or built into the overtube. To date, this has only been attained in experimental models, but this may truly push NOTES into a feasible common practice.
Multifunctional instrumentation
Many of the above features are being incorporated into practical platforms. Modifi ed laparoscopic carbon dioxide insuffl ators with feedback pressure regulators that can be attached to the platform are being developed [18]. Others are integrating unique and proprietary features into devices based on the previously mentioned objectives to create effective translumenal ports that simplify the process of entering, controlling, and exiting the peritoneal space (as an example see Apollo Endosurgery, Austin, TX, USA; www.apolloendo.com ; see also Figure 2.1).
Available endoscopic platforms for NOTES
While reliable access and exit platforms may be forthcoming in the near future, currently NOTES procedures face an
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Figure 2.1 Apollo Endosurgery platforms (OverStitch™, FlexShears ™) (Apollo, Austin, TX, USA) .
additional hurdle: once in the peritoneal cavity, the lack of effective fl exible tools is a serious obstacle to completing the desired procedure in a timely and effi cient manner. The current fl exible endoscope is unable to recapitulate most surgical maneuvers because of intrinsic problems with its design [4]. 1 Force limitations: the modern endoscope cannot effi ­ciently transmit forces that are not aligned with its axis. Further, the fl exibility of the shaft limits the magnitude of even coaxial forces.
2 The “chopstick” effect (lack of triangulation). 3 Size limitations: there is a physical limit to the overall size
of the instrument determined by the natural orifi ce itself and it cannot exceed a diameter that is comfortably and safely tolerated by humans. These and other limitations and their opposite ideal circum­stances have been summarized by the Natural Orifi ce Surgery Consortium for Assessment and Research (NOSCAR) meeting [3] (Table 2.1). New NOTES -specifi c platforms have to overcome these limitations while maintaining their intrinsic fl exibility. Numerous endoscopic systems are being designed with this in mind, yet are far from incorporating all the desired elements. In the following sections, we will briefl y describe some of the state -of-the-art endoscopic plat-
forms currently available either for clinical implementation of NOTES or for its evaluation in the animal or dry lab.
NOTES scope
One of the fi rst systems utilized in the NOTES animal lab was the Olympus R scope (XGIF -2TQ160R Olympus, Tokyo, Japan). This system was later modifi ed into the NOTES scope. In a nutshell, this endoscope is a modifi ed dual ­channel endoscope that has two bending segments, one of which is lockable. Such segments allow simultaneous verti­cal lifting and horizontal dissection motion. This endoscope has standard fl exible endoscopic optics, which are married to the effectors (Figure 2.2). Overall this is one of the most rudimentary NOTES systems presently available.
Incisionless Operating Platform
The Incisionless Operating Platform (USGI Medical, San Capistrano, CA, USA) works on the basis of a fl exible plat­form, using an overtube, and with a steerable and lockable shaft with four different operating channels (7 mm, 6 mm, 4 mm, and 4 mm in diameter), one of which allows for the use of a small fl exible endoscope (N -scope from Olympus, Tokyo, Japan). The endoscope becomes independent of the instrumentation, yet this can become challenging for its
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Figure 2.2 Olympus R Scope (XGIF -2TQ160R)
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(Olympus, Tokyo, Japan) .
CHAPTER 2 Endoscopic Platforms for NOTES
Figure 2.3 Incisionless Operating Platform (USGI Medical, San
Capistrano, CA, USA) .
manipulation. All of the instruments, including the optics, are in a parallel axis (Figure 2.3).
Apollo Endosurgery platforms ( OverStitch™, FlexShears™)
The Apollo Endosurgery platforms (Apollo Endosurgery, Austin, TX, USA) include different technological confi gura­tions that either couple with a double -channel fl exible endoscope and/or are utilized via its operating channels. The main platform (OverStitch ™) allows coupling of a suturing claw to the tip of the fi berscope. This platform is activated through a long mechanical wire located immediately to the side of the endoscope, and with a handle located next to the primary controls of the endoscope (Figure 2.1). The FlexS­hears™ allow use of endoscopic shears to the overall system (Figure 2.1).
EndoSAMURAI
The EndoSAMURAI (Olympus, Tokyo, Japan) was con­ceived under a hybrid premise of a fl exible and laparoscopic system. It employs a locking overtube and a remote working station, which can be used with a more ergonomic user interface than most fl exible endoscopic platforms. Distally it has two independent short, fl exible arms in addition to the working channel, which allows a third interchangeable instrument. The arms are aligned to the body of the endoscope upon entry, but act independ­ently with fi ve degrees of freedom and different effectors, once the endoscope is at the target location. This endoscope permits several ideal surgical qualities such as triangulation, traction, counter -traction, tying of knots, etc. Because of its overtube, it acts as a stable, robust platform (Figure 2.4).
Direct Drive Endoscopic System
The Direct Drive Endoscopic System (DDES) (Boston Scientifi c, Natick, MA, USA) is an endoscopic system also designed under an endoscopic and laparoscopic plat­form. It provides three different channels for interchange­able 4 mm multifunctional instrumentation. Equally as important, it permits the implementation of a user interface for ideal operating ergonomics. The available specialized tools include graspers, scissors, needle pushers, and dia­thermy. Its scope acts independently from the end effectors (Figure 2.5).
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(a)
(a)
(b)
Figure 2.4 EndoSAMURAI (a) user interface and (b) distal end effectors with scope (Olympus, Tokyo, Japan) .
ANUBIS
The ANUBIS system (Karl Storz GmbH, Tuttlingen, Germany) is another sophisticated endoscopic platform, with an ergo­nomic user interface. It allows entry through a single access point for translumenal, intralumenal, or laparoscopic proce­dures, and once it reaches its ideal target location, it deploys three independent end effectors with multiple advanced functionalities. This platform provides triangulation of end effectors along their optical fi eld, and it allows the use of controlled carbon dioxide insuffl ation, which could be used on laparoscopic cases (Figure 2.6).
Disruptive concepts of endoscopic platforms for NOTES
While all of these features are essential for any given NOTES platform, many people are also convinced that NOTES, like any other innovative technique, should replicate all of the
(b)
Figure 2.5 Direct Drive Endoscopic System (Boston Scientifi c, Natick, MA, USA) .
surgical steps that conventional surgery (open and laparo­scopic) follows. This may be where the true paradigm change of NOTES may take place, as others would argue that such replication is not necessary and may hinder its independent success. If NOTES is a truly disruptive technique then it should not only provide an alternative route to do the same kind of surgery as laparoscopy allows, but also it should encourage the innovation of simpler and more effective alternatives to achieve the same clinical outcome. The endo­scopic myotomy technique fi rst described in animals by Pas­richa et al. and then translated into clinical experience by Inoue is an example of such an innovation [15,16].
Unorthodox ways of maneuverability and anatomic expo-
sure need to be explored further. As a distinctive example,
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(a)
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CHAPTER 2 Endoscopic Platforms for NOTES
the “snake fi st ” does not rely on appendages but mainly on fl uid coaxial movements, such as those that could be achieved with an endoscope. These different styles could accomplish the same effi ciencies and desired outcomes in the art of fi ghting. These paradigms may be inspirational to design more functional platforms for NOTES, likely with as good or better results as those presently achieved with con­ventional and sophisticated endoscopic platforms [4].
Conclusions
We have come a long way in our concepts about NOTES and the kinds of technological platforms required. What was seen as futuristic may quickly become part of our daily armamentarium of diagnostic and therapeutic endoscopy. While NOTES itself has not been widely adopted and repli­cated, the technological fallout since its inception, especially of endoscopic platforms, has been substantial. In the future, even more unorthodox ways in how we do endoscopy and surgery may be worth exploring, especially by younger generations.
(b)
(c)
Figure 2.6 ANUBIS (Karl Storz GmbH, Tuttlingen, Germany) .
and following an analogy of Chinese martial arts, two dif­ferent yet highly effi cient ways to attack are the “eagle claw ” (Ying Zhao) and the “snake fi st ” (She Quan) (see Videos 2.1 and 2.2). Both rely on fl uid movements of the attacker. The “eagle claw ” has been described as a collective set of side to side movements of “108 hands ” (Yue Shi San Shou), while
Chapter video clips
Video 2.1 “Snake fi st ” (She Quan) fi ghting technique of martial
arts.
Video 2.2 “Eagle claw ” (Ying Shao) fi ghting technique.
References
1 Pasricha PJ. NOTES: a gastroenterologist ’s perspective . Gastroin-
test Endosc Clin N Am 2007;17:611.
2 Kalloo AN, Singh VK, Jagannath SB, et al. Flexible transgastric
peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity . Gastrointest Endosc 2004;60:114.
3 Rattner D, Kalloo A. ASGE/SAGES Working Group on Natural
Orifi ce Translumenal Endoscopic Surgery. October 2005 . Surg Endosc 2006;20(2):329–33.
4 Mummadi RR, Pasricha PJ. The eagle or the snake: platforms for
NOTES and radical endoscopic therapy . Gastrointest Endosc Clin N Am 2008;18:279.
5 Maiss J, Zopf Y, Hahn EG. Entrance barriers and integration
obstacles of NOTES . Minim Invasive Ther Allied Technol 2010;19(5):287–91.
6 Pasricha PJ. The future of therapeutic endoscopy . Clin Gastroen-
terol Hepatol 2004;2:286.
7 Shaikh SN, Thompson CC. Natural orifi ce translumenal surgery:
fl exible platform review. World J Gastrointest Surg 2010;2(6): 210–16.
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8 Chukwumah C, Zorron R, Marks JM, Ponsky JL. Current status
of natural orifi ce translumenal endoscopic surgery (NOTES) . Curr Probl Surg 2010;47(8):630–68.
9 Zornig C, Mofi d H, Siemssen L, et al. Transvaginal NOTES hybrid
cholecystectomy: feasibility results in 68 cases with mid -term follow-up. Endoscopy 2009;41(5):391–4.
10 Lehmann KS, Ritz JP , Wibmer A, et al. The German registry for
natural orifi ce translumenal endoscopic surgery: report of the fi rst 551 patients . Ann Surg 2010;252(2):263–70.
11 Burghardt J, Buess G. Transanal endoscopic microsurgery
(TEM): a new technique and development during a time period of 20 years . Surg Technol Int 2005;14:131–7.
12 Lacy , AM, Delgado, S, Rojas, OA, et al. MA-NOS radical sigmoid-
ectomy: report of a transvaginal resection in the human . Surg Endosc 2008;22:1717.
13 Kantsevoy S, Jagannath S, Niiyama H, et al. A novel safe
approach to the peritoneal cavity for per -oral transgastric endo­scopic procedures . Gastrointest Endosc 2007;65(3):497–500.
14 Sumiyama K, Gostout CJ, Rajan E, et al. Pilot study of trans-
esophageal endoscopic epicardial coagulation by submucosal endoscopy with the mucosal fl ap safety valve technique (with videos). Gastrointest Endosc 2008;67:497.
15 Inoue H, Minami H, Kobayashi Y, et al. Peroral endoscopic
myotomy (POEM) for esophageal achalasia . Endoscopy 2010;42(4):265–71.
16 Pasricha PJ, Hawari R, Ahmed I, et al. Submucosal endoscopic
esophageal myotomy: a novel experimental approach for the treatment of achalasia . Endoscopy 2007;39(9):761–4.
17 Meireles O, Kantsevoy S, Kalloo A, et al. Comparison of intraab-
dominal pressures using the gastroscope and laparoscope for transgastric surgery . Surg Endosc 2007;21(6):998–1001.
18 Bergstrom M, Swain P, Park P. Measurements of intraperitoneal
pressure and the develop development of a feedback control valve for regulating pressure during fl exible transgastric surgery (NOTES). Gastrointest Endosc 2007;66(1):174–8.
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Physiology of NOTES
Juliane Bingener & Angela M. Johnson
Mayo Clinic, Rochester, MN, USA
This chapter provides an overview of the physiologic impact of the natural orifi ce translumenal endoscopic surgery (NOTES) approach as we understand it today. We review experimental and clinical studies and compare them with prior knowledge from laparoscopy, endoscopy, and open surgery as available. The reader will fi nd that a number of physiologic parameters of importance will be very similar to those investigated with the advent of laparoscopy. This espe­cially concerns the choice of insuffl ation gas and insuffl ation pressures. NOTES resulted from efforts to provide approaches to the peritoneal and chest cavities that may be even less invasive than laparoscopy. The theoretical advantages over open and laparoscopic surgery include less postoperative pain, decreased wound -related complications, possibly less adhesions, possibly faster recovery mediated through a decreased infl ammatory reaction, and improved cosmesis [1]. To organize the physiologic component of NOTES, we have subdivided the topic by organ system. We wish to address the nervous and musculoskeletal systems in regards to pain, the respiratory system including acid -base changes, the cardiovascular impact, as well as the physiologic implica­tions for the gastrointestinal (GI) tract, and the hematologic and immunologic systems.
Why should NOTES be different than laparoscopy?
In traditional laparoscopy, carbon dioxide is the insuffl ation gas of choice as it is safe, inexpensive, noncombustible, and colorless. It is excreted by the lungs and is highly water soluble, reducing the risk of gas embolism seen with com­pressed air. Endoscopic compressors do not routinely include a CO
insuffl ation component but use compressed air.
2
However, a CO
insuffl ator can be provided for the endo-
2
scope and has been used for intraluminal insuffl ation with good results. Due to the uncontrolled insuffl ation used in endoscopy, concerns have been voiced regarding high intra ­abdominal pressures with negative impact on the cardiovas­cular and respiratory system. In addition, the question of an infectious component by breaching the GI wall is certainly a concern that has to be addressed. A number of these con­cerns were outlined in the White Paper by Kalloo and Rattner in 2006 [2].
Central and peripheral nervous systems
The central and peripheral nervous systems (CNS, PNS) are the sites of a major consequence of surgical intervention: pain. Pain is now recognized as the “fi fth vital sign ” in clini­cal practice and its impact on recovery is well described. Less well known are reports that postoperative pain may contrib­ute to more rapid tumor growth [3]. The NOTES approach seeks to avoid creating pain by utilizing access routes with limited pain receptors such as the GI tract or the posterior vault of the vagina [4,5].
Experimentally, this hypothesis is supported by a prospec­tive randomized controlled trial of transgastric oophorec­tomy in canines [6]. This experimental model measured the nociceptive threshold of animals undergoing NOTES, lapar­oscopic, or open procedures using postoperative abdominal cuff insuffl ation. The nociceptive threshold measurement is a method to establish an individual subject ’s pain threshold using standard stimuli. For example, a blood pressure cuff is infl ated around a subject ’s arm and when the subject expresses pain, that pressure is recorded as the threshold. The initial pressure constitutes the baseline and can be com­pared between individuals and groups. After a painful stim­ulus, such as a surgery, the threshold for the blood pressure
Natural Orifi ce Translumenal Endoscopic Surgery (NOTES): Textbook and Video Atlas, First Edition. Edited by Anthony N. Kalloo, Jacques Marescaux,
Ricardo Zorron.
© 2012 John Wiley & Sons, Ltd. Published 2012 by John Wiley & Sons, Ltd.
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cuff around the arm to cause pain is usually lower as the pain fi bers are “wound up. ” In this study, the nociceptive threshold was measured using abdominal cuff insuffl ation after surgery. The study reported that the nociceptive thresh­old of animals undergoing NOTES was decreased less than those undergoing an open procedure. The NOTES animals also tolerated signifi cantly higher abdominal cuff pressures as early as 18 hours postoperatively compared to animals that underwent laparoscopy or an open procedure. Of note, the study described a shorter time to gastrointestinal motility for those animals undergoing NOTES oophorectomy [6].
Clinically, a comparative study by Zorron et al. also reported a decreased need for pain medication in patients undergoing transvaginal cholecystectomy. He compared patients undergoing transvaginal cholecystectomy with standard laparoscopic cholecystectomy. In the transvaginal cholecystectomy group, 50% of the patients did not request any pain medication. Conversely, in the group undergoing standard laparoscopic cholecystectomy, all patients requested pain medication [7]. The group led by Roberts has recently reported similar fi ndings for transvagi­nal appendectomy [8]. In a series by Horgan et al., the visual analog pain scale was used with patients undergoing NOTES procedures. Subjectively, patients reported pain levels less than 2.5 in the fi rst 24 hours status post NOTES procedures, which would be below the level at which pain medication, in general, is offered [9]. Although these preliminary reports support the decreased pain reaction after NOTES proce­dures, data from well -designed randomized multicenter trials are still pending.
Respiratory system and acid-base disturbance
From comparisons of laparoscopic and open surgery, we know that the respiratory impact of surgical procedures can be described in several components: the intra - and peri ­operative atelectasis resulting from intra -abdominal pres­sure and positioning, the intraoperative hypoxia and hypercapnia noticed on the oxygen saturation and blood gases, and postoperative pain limiting respiratory excursion with decrease in vital capacity and tidal volume. The post­operative pain has been addressed above. Here we will review the effects of intra -abdominal and intrathoracic pres­sure and the acid -base disturbances caused by the insuffl a­tion gases.
Intra-abdominal and intrathoracic pressure
The intra -abdominal pressures measured by a Veress needle and endoscope appear to be fairly similar in several studies [10]. In the chest cavity, however, the pressures measured with the endoscope and the Veress needle, in a study by von Delius et al., were 13% higher than the measured endo-
scopic pressure. This has to be taken into account when relying solely on the endoscopic pressure [11].
Multiple studies have investigated the effect of intra ­abdominal insuffl ation on the respiratory status comparing NOTES and laparoscopic procedures. These experimental procedures did not fi nd any difference in clinically apparent events between laparoscopy and NOTES groups [12–15]. This applied to studies where pressure -controlled insuffl a­tion was used, including high intra -abdominal pressures such as pneumoperitoneum of 20 mmHg. Diverging results have been reported from studies using on -demand insuffl a­tion. While studies investigating diagnostic NOTES proce­dures encountered a decrease in intra -abdominal pressure recorded during on -demand procedures [16], complex NOTES procedures revealed that signifi cantly elevated intra ­abdominal pressures were realized [17]. The pressure read­ings in the on -demand insuffl ation group in one study revealed pressures higher than 15 mmHg 20% of the time. However, with increased intra -abdominal pressure, no clini­cal differences were noted during the operative procedure itself.
The intra -abdominal hypertension was associated with a rise in the peak -inspiratory pressures measured up to 40 mBar. The increased peak -inspiratory pressure indicates reduced pulmonary compliance and increased pulmonary resistance. In the control group, with a constant insuffl ation pressure of 12 mmHg as measured by Veress needle, the maximum peak -inspiratory pressure was 26 mBar.
Abdominal insuffl ation gas
From a pulmonary and acid -base standpoint, the gas used to initiate and maintain pneumoperitoneum is important. Similar to laparoscopy with CO is noted in the NOTES carbon dioxide groups. This rise is usually transient and stabilizes, and is reversible with the cessation of the procedure, similar to laparoscopy. The rise in pCO
and associated decrease in blood pH was seen in
2
several studies [12,14]. This was avoided with NOTES pro­cedures using air insuffl ation and also with NOTES proce­dures using lower intra -abdominal pressure, both with air and CO
. The hypercapnia that resulted from 12 –15 mmHg
2
intraperitoneal pressure with CO piratory effort, which leads to refl ex tachycardia, vasocon­striction, and a decrease in oxygenation. The decrease in oxygenation was seen with increased abdominal pressures (12 mmHg) and the use of CO groups, this did not become clinically signifi cant in the experimental setting [12,15].
Postoperatively, no clinically diverging results have been reported. However, we are not aware of studies examining vital capacity in the postoperative period for NOTES com­pared to laparoscopy. A histologic study investigated the rate of pulmonary abnormalities in experimental swine at necropsy, 14 days after NOTES or laparoscopy procedures.
, a signifi cant rise in pCO
2
requires an increased res-
2
. Again, in the experimental
2
2
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CHAPTER 3 Physiology of NOTES
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A statistically signifi cantly higher rate of pneumonitis was seen in swine undergoing laparoscopy compared to swine undergoing NOTES procedures. Pneumonitis is not infre­quent in laboratory swine and all had undergone 14 days of pre-operative quarantine prior to any operative procedure. A possible reason for the increased pneumonitis may be the increased mean intra -abdominal pressure recorded in the laparoscopic group [18].
Cardiovascular system
Research during the introduction of laparoscopic cholecys­tectomy revealed that pneumoperitoneum decreases venous return and subsequently cardiac output. For most clinical situations and short laparoscopic procedures this effect is outweighed by the decreased physiologic impact in other aspects of the approach (pain, respiration, wound healing). For patients with limited cardiopulmonary reserve (e.g., septic shock, pulmonary hypertension), a small decrease in venous return, however, can be detrimental. A number of studies investigated the cardiovascular effects of NOTES with CO
or air in comparison to laparoscopy or
2
endoscopy.
Cardiovascular parameters such as heart rate, mean arte­rial pressure, cardiac index, end diastolic volume, and sys­temic vascular resistance index were investigated [12,15,19].
Transgastric access
Intra-abdominal pressure during NOTES pneumoperito­neum appeared to affect cardiovascular parameters when comparing on -demand with high abdominal pressures and pressure-controlled insuffl ation. During on -demand insuf­fl ation pneumoperitoneum in experimental animals, decreased heart rate was observed; cardiac index declined; minor variations in mean arterial pressure were noted that did not reach statistical signifi cance; and systemic vascular resistance index was markedly elevated in three animals and unchanged in the remainder. Pneumoperitoneum in the control group was held constant at 12 mmHg. The control group experienced a similar decrease in heart rate, increase in mean arterial pressure, increase in cardiac index, increase in global end -diastolic index, and decrease in systemic vas­cular resistance index [14].
When on -demand pressure resulted in intra -abdominal pressures lower than laparoscopy and NOTES with air was used, the heart rate increased over 90 min in the laparoscopy group but decreased in the NOTES group [16].
Mean arterial blood pressures were statistically signifi ­cantly increased across all study groups during pneumoperi­toneum; however, this was least pronounced in the NOTES air insuffl ation group. No statistically signifi cant change was noted in cardiac index in either NOTES group. A statistically signifi cant increase in cardiac index, upwards of 17%, was
noted in the laparoscopic group. Likewise, no statistically signifi cant increase in end -diastolic volume was noted in the NOTES groups. The laparoscopic group illustrated a statistically signifi cant increase in end -diastolic volume. The systemic vascular resistance was noted to be statistically signifi cantly increased during pneumoperitoneum in the NOTES carbon dioxide group; this increase was not statistically signifi cant with NOTES air insuffl ation or laparoscopy.
In a study comparing NOTES, laparoscopy, and endos­copy, heart rate and diastolic blood pressure were similar for NOTES and endoscopy.
None of the changes noted in experimental animals proved to lead to clinically apparent hemodynamic instabil­ity; however, one must account for the fact that study animals were all young and healthy. The marked increase of systemic vascular resistance index in three animals was indicative of a stress response [14].
Mediastinal access
Hemodynamic effects of on -demand air insuffl ation during transesophageal mediastinoscopy have also been investi­gated [11]. During uncomplicated mediastinoscopy, no cor­relation was noted between insuffl ation pressure and cardiac index, systemic vascular resistance, heart rate, and mean arterial pressure. A statistically signifi cant decrease in cardiac index during NOTES mediastinoscopy correlated with an increase in systemic vascular resistance. This may be a stress response to endoscopic surgery.
No complications were noted regarding access to the mediastinum through the esophagus and this necessitated a limited amount of air insuffl ation for visualization. During endoscopy, however, small tears were made in the parietal pleura leading to left -sided pneumothoraces in three of eight study animals. This was unrecognized and fatal in one animal. Pleural injury was a signifi cant complication in three of their eight study animals, leading to death in one; there­fore, inadvertent parietal pleura injury and resultant pneu­mothorax is a large risk for this procedure [11].
Transvaginal access
Cardiovascular effects of transvaginal cholecystectomy were compared to those of traditional laparoscopic cholecystec­tomy. The peritoneal cavity was insuffl ated with carbon dioxide in both study arms with pressure -controlled pneu­moperitoneum. No hemodynamic instability was noted in any study animal. No statistically signifi cant change in hemodynamics was noted in the NOTES or laparoscopic group [13].
The cardiovascular effects appear to be pressure and gas related, just as in traditional laparoscopy. Higher intra ­abdominal pressures lead to larger negative effects and CO does have a measurable but usually not clinically deleterious impact.
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