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NOTES might be a way to use regional anesthesia or
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general sedation without taking on the risks of general surgery and intubation.
Advantages of NOTES over laparoscopy
A major advantage of NOTES over laparoscopy could be the decreased intraperitoneal pressure needed compared to laparoscopy [45]. Two technical aspects could allow a decrease in the abdominal pressure: fi rst, the use of an ech­oendoscope, which could add the ultrasound information to the direct vision (to puncture a specifi c organ, for example), and second, the mobility of the endoscope allows a smaller “operative fi eld, ” closer to the targeted organ by adapting the vision in a 360 ° degree manner. A decrease in pressure could decrease the risk of acidosis [26,46] as well as lower postoperative infl ammatory response [47,48], postoperative pain [28, 49] , and adhesion formation [50]. A decrease in pneumoperitoneum pressure could also improve the man­agement of ventilation [51], a major concern for pregnant women as the gravid uterus encroaches upon diaphragmatic excursion [52,53].
One of the biggest advantages to NOTES is that it leaves free access to the abdominal wall to allow fetal heart moni­toring with cardiotocography or Doppler apparatus more easily than during laparoscopy. The fetal heart could also be observed using an echoendoscope, which allows direct vision of the fetal heart [41].
Use of an echoendoscope could allow a safer entry in the abdominal cavity [54], avoiding uterus injury. Transabdomi­nal ultrasound guidance could be used for transgastric access, or transvaginal and transillumination could also be used. During the end of the second and the third trimester transgastric access is more challenging: depending on the gestational age, the distance between the gastric wall and the uterine fundus may vary from a few centimeters to direct contact (Figure 21.3). Further animal studies in late pregnancy should be performed to determine the safest technique for access. Closing the NOTES incision in a safe manner will also be challenging, but theoretically NOTES would have less risk of leak during pregnancy, since higher intra-abdominal pressure can compensate for any increase in intralumenal pressure.
With NOTES, transabdominal ultrasound also allows eval­uation of the posterior vaginal vault, which becomes more diffi cult laparoscopically with advancing gestational age. Most of the techniques of the transvaginal access for NOTES in women have been performed using a classical vaginal vault incision; however, in one animal study transvaginal access was obtained using only a puncture and a dilatation balloon. The transvaginal route also allows a retroperitoneal approach [55] that could enable the treatment of retroperi­toneal pathology in pregnant women and also could extend to the uterine fundus, thereby avoiding a transperitoneal entry. Transvaginal access can allow a straight trajectory to
CHAPTER 21 NOTES and Pregnancy
Figure 21.3 MRI showing anatomical connection between the uterus
and the gastric wall during the third trimester. †, Colon; *, Stomach; #, Fetus.
treat non -gynecologic pathologies (Figure 21.4) such as appendicitis and cholecystitis, the two most frequent pathol­ogies that require surgery during pregnancy. As with all transvaginal surgeries in pregnancy, healing of the vaginal cuff must be complete before delivery or a dehiscence of the site during labor or delivery could occur.
Obesity
Obesity has become a worldwide concern, with over 30% of adults estimated to be obese in the United States. This makes any surgery more challenging, either open or laparo­scopic [56]. NOTES has a major potential advantage in the obese pregnant population because the access remains unimpeded regardless of the BMI of the patient [57].
Infectious risk
Questions of infectious risk for the fetus and the parturient during NOTES need to be clarifi ed since pathogens have been implicated in miscarriage, preterm delivery, and PPROM [58]. In the study we reported [41], for the non ­survival animals chemical disinfection was used for the endoscope and accessories without any other precaution (such as gastric or oral cavity lavage or parenteral antibiot­ics). For the survival animal, a high -level disinfection solu­tion 0.55% ortho -phthalaldehyde (Cidex OPA, Ethicon Inc., Irvine, CA) and then gas sterilization with ethylene oxide
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Abdominal wall
Head
Transgastric NOTES
Figure 21.4 Transvaginal and trangastric access during pregnancy.
Uterine wall
Legs
Transvaginal NOTES
Back
were used. For the puncture site (vagina) a broad -spectrum topical iodophor microbicide (10% povidone -iodine) was used along with standard sterile surgical technique. In addi­tion, the animal received Intravenous antibiotic (1 g cefazo­lin). After a period of four weeks, there was no sign of infection and necropsy did not fi nd damage. In a recent paper Memark et al. found a contamination of the peritoneal cavity during transgastric NOTES but this did not lead to an increased risk of infectious complications [59]. Eickhoff et al. in a porcine model described a peritoneal bacterial load to almost zero using intravenous antibiotics, topical antimi­crobial lavage of mouth and stomach, and treatment with proton pump inhibitors [60]. Our team showed that with sterile technique, no signs of infectious disease were found compared to 100% of infectious complication when no sterile conditions were used for transgastric access [61]. Further research has to be performed, particularly in a preg­nant model, to better assess the best choice in infection prophylaxis [62].
Infl ammation and NOTES
Infl ammation and increase in cytokines secretion are one of the potential mechanisms of preterm delivery [63]. Three animal studies have reported the assessment of postopera­tive pro -infl ammatory cytokines comparing NOTES and laparoscopy with mixed results. All studies were hampered by design fl aws, including use of different gases and pres­sures between study groups and controls [64–67]. Further studies are needed in pregnant models to determine the nature and effect of the infl ammatory response in NOTES procedures.
Energy
Another research question to be answered is what energy to use. Although the ASGE recommends bipolar devices,
there are few such devices in endoscopy practice [68] and the need for energy (in terms of time and power) are higher during abdominal surgery compared to endo­scopic practice. Bipolar devices are preferred when surgery is performed near the uterus to avoid the risk of electrical arc with monopolar cautery and potential consequences to the fetus.
Devices and instrumentation
During the past fi ve years signifi cant progress has been made in developing new devices and instrumentation for NOTES [69]. The operative fi eld is largely reduced by the uterine volume, but contact with the gravid uterus should still be minimal to avoid trauma. To that end, new endoscopes, magnetic anchoring guidance systems, and robots are in development, and will require thorough evaluation prior to clinical use. Research will allow major technical improve­ment but the learning curve for training and skills still needs to be resolved [70,71]. The pregnant ewe is a good animal model to deal with the technical issue of NOTES during surgery as it can develop similar complications such as infec­tion, preterm labor, and preterm delivery. The clinical appli­cability between this model and human beings in NOTES has not been fully elucidated. The primate model most closely resembles the human reproductive system but has also not been studied in NOTES.
Potential advantages and challenges in developing NOTES during pregnancy are summarized in Table 21.1. NOTES could be part of a solution to decrease both maternal and fetal risk of surgery during pregnancy by potentially provid­ing improvement in risks regarding anesthesia, analgesia, better access in the obese patient, easier fetal monitoring, and easier and safer access to the peritoneal cavity. However, the data in the literature is only in its infancy, leaving many research opportunities to develop this technique.
236
Table 21.1 Potential advantages and pitfalls to NOTES during pregnancy for maternal pathology.
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Laparoscopy NOTES
Anesthesia General required General, could be regional Cardiopulmonary parameters Altered Unknown Thomboembolic events Well known, well managed Unknown Pain Easily manageable May be less Increased BMI/obesity More challenging Easier access Fetal-uterine monitoring Challenging Could be easier Pneumoperitoneum Pressure 10–12 mmHg Could be lower
Creation Risk of uterine injury Can be visualized at entry Number of ports 1–3 1 Abdominal scar 1–3 None Infectious risk Minimal Unknown
Bold, the expected advantages of NOTES versus laparoscopy.
Access to the fetus and to the placenta: intra-amniotic surgery
Introduction
Intrauterine surgery is, perhaps, the “fi nal frontier ” of obstetric surgery, and NOTES could potentially play a vital role. PPROM, preterm labor, and infection continue to be common complications of open fetal surgery despite exten­sive animal work using sheep models, and maternal compli­cations are also a major concern. Endoscopic fetal surgery appears as one solution to decrease the trauma to the fetus and to the mother [5,72]. In -utero repair of fetal anomalies holds great promise to mitigate the effects of birth defects. A recent paper on fetuses with myelomeningocele reported a reduced need for shunting and improved motor outcomes in the prenatal surgery group versus postnatal surgery group [73]. However, open prenatal surgery was associated with increased maternal and fetal risks; thus, this study is a strong argument not only for prenatal surgery but also for progress in fetoscopic surgery. The risks are still substantial: in 2002 Fowler et al. reported morbidity rates of 47% and 49% for chorioamniotic separation and PPROM, respectively, in 66 cases of twin -twin transfusion syndrome (TTTS) and con­genital diaphragmatic hernia after endoscopic surgery [74]. Decreasing risks associated with fetal surgery would mean lowering invasiveness, easier access to the intrauterine cavity, shorter operating times, smaller and fewer ports, and decreased need for pump fl uid exchange [74].
The most common condition leading to intrauterine surgery is TTTS, where arterial and venous shunts between twins leads to hydrops and high output cardiac failure in one twin and growth restriction and decreased perfusion in the other. Affecting 15 –20% of all monochorionic twin ges-
CHAPTER 21 NOTES and Pregnancy
tations, it has a high mortality rate if left untreated. Surgical treatment involves coagulation of these anastomoses using laser. A single 3 mm access is necessary; however, rates of PPROM remain high (around 20%) [75]. Another condition treated in utero is diaphragmatic hernia, which involves placement of a balloon in the fetal trachea to stimulate lung growth and maturation [76–78].
One major problem of accessing the uterine cavity is the location of the placenta. An anteriorly located placenta limits and sometimes blocks access to the uterus, affecting fetal outcome [79,80]. Similarly, fetal lie can make fetoscopy impossible. These diffi culties can sometimes be avoided using a laparoscopically assisted access [80], but that still requires two or three transabdominal trocars: one for the laparoscope, one for the fetoscope, and sometimes one for a blind probe to maintain the uterus and to avoid injury to intraperitoneal organs [81]. One study compared laparoscope ­assisted fetoscopy and the percutaneous approach for surgi­cal treatment of TTTS with anterior placentation and found the neonatal survival rate was better in the laparoscopic ­assisted group compared to the percutaneous group (80% versus 59%, respectively; p = 0.045) [80]. Operative time was longer for laparoscopy, and there was a non -signifi cant difference in the rate of PPROM and age of delivery.
Another problem during in -utero surgery is closure of the uterus and avoiding amniotic leak. Several studies have examined potential strategies to prevent PPROM, including gelatin sponges, instillation of platelets (amniopatch), micro­fi brillar collagen, and various combinations of fi brinogen, thrombin, platelets, and fi brin glue [82,83] but all yielded suboptimal results. The other issue is the closure of the myometrium, which is easily performed in open surgery (absorbable suture) but which is rarely done by minimally invasive surgery.
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Visualization in utero presents challenges, as the amniotic fl uid can be very opaque. One procedure used to improve visualization is a continuous exchange of amniotic fl uid with crystalline solutions, but the volume that can be exchanged via the fetoscope is very little and not suffi cient in the case of intra -amniotic bleeding. Many authors have proposed the use of intra -amniotic insuffl ations with CO nitrous oxide in animal studies [19–25], with limited results in term of visualization. Further studies are needed to assess the innocuousness of intra -amniotic insuffl ation.
, air, helium, or
2
NOTES for intra-amniotic surgery during pregnancy
Review of the literature
Only one study exists in the literature that studied NOTES and intrauterine surgery [41]. Intraperitoneal access used in this study was described earlier. For the in utero portion, we compared traditional abdominal obstetric sonography and translumenal endoscopic ultrasound (TEUS). TEUS allowed a reliable and accurate examination of the fetus (Video
21.2). Using a 22 gauge needle, the fetal heart, hepatic parenchyma, umbilical vessels, and intrahepatic portion of the inferior vena cava were all successfully accessed. No immediate complications (bleeding, PPROM, organ damage) were described during the postoperative 30 minutes of ultra­sound observation and at the immediate necropsy for the two non -survival animals. In the survival animal, four weeks later no complication (infectious or tissue damage) was observed during necropsy.
Advantages of NOTES for intrauterine surgery
NOTES could play a major role in advancing intrauterine surgery in the following ways.
Access to uterine wall
The freedom of the access to the uterine wall should be the strongest argument to develop NOTES for intra -amniotic access. While a laparoscope only allows a straight access, NOTES ensures a 360 ° access with a potential low posterior access through the vagina. Entry into the uterus could be easily adapted to the location of the placenta and/or the fetus (Figure 21.5). The initial puncture point could be located using the direct endoscopic vision or using echoen­doscopy. With the latter, ultrasound is placed in direct contact with the uterus, not the abdominal wall, with a potential better assessment of the intrauterine contents. This would be a particular advantage in the obese patient, as TEUS would circumvent the abdominal wall barrier.
The pressure of the pneumoperitoneum could be largely decreased with this direct ultrasound guidance. Entry could also be perfectly adapted to the orientation of the uterine wall, allowing a 90 ° angle entrance in all cases. Another potential benefi t could be the lack of lever effect between the abdominal wall and uterus that occurs using a rigid
fetoscope. With an endoscope both the entry point (vagina or gastric wall) and the devices themselves are less rigid. Similarly, when posterior access to the uterus is required, a rigid probe is often used to elevate the organ anteriorly; a fl exible endoscope could navigate posteriorly without sub­stantial manipulation.
Devices and instrumentation
A critical component to the success of NOTES is to reduce the size of the devices. The trocar sizes used for fetoscopic surgery are between 2 mm and 6 mm; therefore, the diam­eter of the endoscope should not exceed this size. Given the technological progress in the miniaturization of surgical instrumentation there is strong hope of availability of micro ­endoscopic surgical devices in the next few years. Multiple instrument changes contribute to the high rate of fetal mem­brane injury after fetoscopic surgery (up to 60%) [74,84,85]. With NOTES, the integrated device (camera, suction, instru­ment) used during NOTES obviates the need to withdraw the endoscope to change instruments. The major challenge will also be how to create the entry point: a wire -guided dilatation balloon could be used but may result in a large leak of amniotic fl uid in the peritoneal cavity. Specifi c devices and techniques have to be developed to insure this way through the uterine wall [86]. The freedom of trans ­uterine puncture adaptation (angle, location) is an argu­ment for using NOTES because the instrument trajectory through the uterine wall is not limited by the endoscope ’s angle through the abdominal wall. For example, in hypo­plastic left (or right) heart syndrome some authors propose in-utero aortic (or pulmonary) valve dilatation. Entry into the uterus would thus be dependent on fetal lie. NOTES may be helpful in these cases, because the fetal structures could be accessed regardless of fetal position [76,85,87].
Closure of the uterus
As opposed to the actual practice during minimally invasive obstetric surgery (lack of uterine closure in most cases), techniques and material used during NOTES procedures could allow the closure of the uterine wall. The adequate technique has to be determined but many devices are avail­able for gastric closure and should allow a satisfactory closure of the uterine wall.
Infectious
The rate of postoperative chorioamnionitis following intra ­amniotic surgery seems to be relatively low (less than 5%) [88] and occurred more frequently in fetuses that did not receive antibiotics at the time of the procedure [89]. Even though an in vitro study demonstrated the antibacterial properties of human amnion and chorion [90], many vaginal bacteria have been described as potential causes of preterm labor, chorioamnionitis, and PPROM. Moreover periodontal diseases and oral bacteria have been described as possible
238
Abdominal wall
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CHAPTER 21 NOTES and Pregnancy
Left
(a)
Legs
Laparoscopic
angle of access
Placenta
NOTES
potential angle
of access
Back
Abdominal wall
Placenta
Uterine wall
Right
Laparoscopic
angle of access
Uterine wall
Head
NOTES potential
zone of access
(b)
Figure 21.5 Potential angle of access to the uterine cavity: comparison between NOTES and laparoscopic surgery. (a) Transversal view, (b) sagittal view.
causes of preterm labor [91,92]. As we described above, infectious risk and contamination during NOTES is still debatable and no one can actually predict the potential infectious risk for the fetus, and the objective of zero germ using NOTES seems hard to reach.
As for exclusive maternal surgical pathology, NOTES could be one part of the solution to decrease both maternal and fetal risk of surgery during pregnancy. To summarize,
Laparoscopic
zone of access
Back
improvements could include better uterine wall access, better trajectory for trans -uterine treatment, better intrau­terine targeting, reduced need for an intrauterine operative fi eld using gas or liquid, and enhanced closure of the uterus. Animal research is also needed to evaluate these potential advantages of NOTES. Technical improvement, especially miniaturization, is the most urgently required aspect to develop NOTES for maternal pathology during pregnancy.
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Fetal NOTES
Specifi city of “intra-fetal” surgery
The most common pathology that would require intra ­abdominal access to the fetus is congenital diaphragmatic hernia (CDH). Open surgery is too invasiveness and has a very high morbidity despite good anatomical results [76]. Endoscopic surgery using multiple ports offered a new approach with variable results [93], then a single access was described [94] with more promising results. Despite the decrease of invasiveness, results are still controversial [84]. So far, major procedures using open or fetoscopic surgery have been hampered by high morbidity, and non -invasive fetal treatments of congenital malformations do not exist. These limitations open doors to other advanced but mini­mally invasive treatment [76,85,87].
healing potentially enables fetal NOTES without any closure of the fetal access. This scarless healing is itself an argument to perform surgery for congenital anomalies before rather than after birth [101]. Moreover, a recent paper [103] com­paring gastrotomy closure with endoscopically delivered bioabsorbable plugs with no closure (animal model, 23 dogs) found no complication in untreated animals, with adequate healing and fewer adhesions compared to the closure group. These combinations of data may open a hope of self -mucosal healing after fetal surgery.
Today, fetal NOTES is just a concept but the alliance between technological improvement and miniaturization with the potential in utero healing characteristic may open the way to this surgery.
Conclusion
Fetal NOTES
Review of the literature
To our knowledge, there are no reports of NOTES performed in the fetus; however, oral access has been used for fetal surgery [76]. CDH treatment is attempted by oral access but other procedures using this access have been reported. Kohl et al. reported a transesophageal echocardiography during balloon valvuloplasty [85]. The transesophageal approach permitted clear visualization of the fetal heart. Another transabdominal procedure, fetal cystoscopy, has been used as a diagnostic and treatment tool for severe lower urinary tract obstruction [95–97]. Trans -urethral ablation of poste­rior urethral valves could be a fi rst step for fetal NOTES. However, no intra -abdominal access or intra -thoracic access in the fetus via NOTES has been described.
Pitfalls and perspectives in the development of intra-amniotic NOTES
Infectious concern
Since the intrauterine environment itself is sterile, the infec­tious concern for fetal NOTES will most likely be with regard to maternal infection.
Access to natural orifi ce, device, and instrumentation
Fetal NOTES will necessitate a huge improvement in mate­rial and device miniaturization (from micro -camera to nano ­device), which may be available in the next decade [98,99].
Closure of the natural orifi ce
In the literature, there are few reports about urinary ascites or urinoma following trans -uterine placement of vesicoam­niotic stents [87,100]. In an animal model of vesicotomy created by laparoscopy the healing was very fast. An attrac­tive element of fetal NOTES is that fetuses have virtually scarless healing, which could be attributable to the high level of growth hormones in amniotic fl uid [101,102]. This
NOTES has the potential to decrease both maternal and fetal risk of surgery during pregnancy. However, there is little laboratory and no human experience to date. We explored potential advantages and challenges to developing NOTES during pregnancy for maternal, placental, and fetal patholo­gies. Technical improvement and miniaturization is critical to develop NOTES for surgery during pregnancy.
Chapter video clips
Video 21.1 NOTES peritoneoscopy demonstrating gravid
uterus. (Courtesy of Samuel Giday.)
Video 21.2 Fetal heart by NOTES (TEUS).
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54 Elmunzer BJ, Schomisch SJ, Trunzo JA, et al. EUS in localizing
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55 Bourdel N, Kondo W, Botchorishvili R, et al. Assessment of
sentinel nodes for gynecologic malignancies by natural orifi ces transluminal endoscopic surgery (NOTES): preliminary report . Gynecol Oncol 2009;115:367–70.
56 Chohan L, Kilpatrick CC. Laparoscopy in pregnancy: a litera-
ture review . Clin Obstet Gynecol 2009;52:557–69.
57 Chouillard EK, Al Khoury M, Bader G, et al. Combined vaginal
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60 Eickhoff A, Vetter S, von Renteln D, et al. Effectivity of current
sterility methods for transgastric NOTES procedures: results of a randomized porcine study . Endoscopy 2010;42:748–52.
61 Giday SA, Dray X, Magno P, et al. Infection during natural
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64 Bingener J, Krishnegowda NK, Michalek JE. Immunologic
parameters during NOTES compared with laparoscopy in a randomized blinded porcine trial . Surg Endosc 2009;23: 178–81.
65 Basgul E, Bahadir B, Celiker V, et al. Effects of low and high
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66 McGee MF , Schomisch SJ, Marks JM, et al. Late phase TNF -
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68 Park PO, Long GL, Bergstrom M, et al. A randomized compari-
son of a new fl exible bipolar hemostasis forceps designed prin­cipally for NOTES versus a conventional surgical laparoscopic bipolar forceps for intra -abdominal vessel sealing in a porcine model. Gastrointest Endosc 2010;71:835–41.
69 Granberg CF , Gettman MT . Instrumentation for natural orifi ce
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Thoracic Cavity Application of NOTES
Alex Escalona,1Brian G. Turner ,2& Denise W. Gee
1
Pontifi cia Universidad Cat ólica de Chile, Santiago, Chile
2
Weil Cornell Medical College, New York, NY, USA
3
Massachusetts General Hospital, Boston, MA, USA
Introduction
Since the introduction of laparoscopic cholecystectomy, minimally invasive surgical techniques have become the standard approach in various areas of surgical practice. In the fi eld of thoracic surgery, video -assisted thoracoscopic surgery (VATS) and video -assisted mediastinoscopy (VAM) were developed as minimally invasive alternatives to open surgery. VATS, initially introduced as a diagnostic tool for pleural biopsies, wedge resections, blebectomies, and lung biopsies, has evolved as an alternative treatment in malig­nant conditions such as lung cancer [1]. Compared to con­ventional mediastinoscopy, VAM has shown similar results in terms of safety and effi cacy [2]. Overall, these thoracic techniques have been associated with shorter hospital stay, less pain, and fewer postoperative complications, especially in high -volume centers, and are now a standard of care for many thoracic diseases [3].
Over the past decade, natural orifi ce translumenal endo­scopic surgery (NOTES) has emerged as a novel, potentially less invasive, alternative to laparoscopic surgery [4]. Indeed, after numerous animal studies and increasing reports of suc­cessful human experiences, this new fi eld has gained inter­est and attention among surgeons, gastroenterologists, and industry alike [5]. Thoracic NOTES has not been an excep­tion and many groups have dedicated their time to the study and development of this new area of research. However, contrary to the rapid development of laparoscopic surgery a decade before, the complexity of NOTES and the necessity for new technology have resulted in a slower transition to human studies, especially in thoracic surgery. This is one of the main reasons why the majority of thoracic NOTES research has been based on animal models.
3
The purpose of this chapter is to review the thoracic cavity application of NOTES based on the current available data in animal and human studies, to evaluate different approaches and techniques, and to discuss the future work needed to advance into human trials.
Access to the thoracic cavity
The concept of NOTES implies the use of a natural orifi ce to access the human body cavities. In the case of the thorax and mediastinum, the mouth is perhaps the most natural and feasible access route, making the transesophageal approach the most commonly used technique and the major focus of this chapter. Other access routes, however, have also been described and merit discussion. These include transtracheal and transdiaphragmatic approaches. Yang et al. described the feasibility of transtracheal access for endo­scopic evaluation of the mediastinum and thoracic cavity [6]. The procedure was performed in two canines. One required chest tube drainage to manage postoperative sub­cutaneous emphysema. Both animals survived for two weeks with good healing of the tracheal wounds. Another series described the feasibility of a pericardial window in 14 canines using the same transtracheal approach [7]. Based on their previous experience, the authors used intraoperative pleural drainage to decrease the rate of pneumothorax as well as a stent to cover the tracheal incision [8,9]. Peri ­operative mortality was reported in 3 of 14 animals. The remaining 11 animals survived without complications for 2 weeks. Liu et al. described the same approach to perform pleural biopsy, lung biopsy, and pericardial window in six pigs and six dogs [7]. Four animals died peri -operatively secondary to tension pneumothorax in two pigs and one dog
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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