Key points

Introduction

Because the cornerstone of new natural orifice translumenal endoscopic surgery (NOTES) procedures is endoscopic submucosal dissection (ESD), the parent procedure, so to speak, of all new NOTES interventions, Western endoscopists were at a distinct disadvantage compared with their Asian colleagues in the adoption and development of new NOTES procedures. ESD was invented in Japan for en bloc resection of early gastrointestinal (GI) neoplasms, mainly early gastric cancer (found in Asia at approximately 8 times the incidence in the United States), and was widely applied there starting in 2000. For more than a decade, ESD did not gain any significant adoption in the United States. This was in part owing to the scarcity in the West of easy ESD target lesions available in abundance in Asia (early gastric cancer and squamous carcinoma of the esophagus), and the perception of ESD as a time-consuming, technically demanding, difficult to learn, and risky technique without clearly proven benefits over endoscopic mucosal resection in the lesions most common in the West such as colorectal neoplasms. Largely influenced by this negative climate, Olympus and ERBE did not pursue US Food and Drug Administration approval of ESD electrosurgical knives in the United States until 2010, after the advent of peroral endoscopic myotomy (POEM). Most knives became finally commercially available in the United States in 2011. At our center, early ESDs from 2005 to 2011 and POEMs from 2009 to 2011, were performed using a standard non-ESD needle knife resulting in a riskier and less efficient resection. Interestingly, the advent of POEM did, in 2 to 3 years more, to stimulate adoption of ESD in the United States than more than 10 years of favorable publications and demonstrations of ESD by Asian endoscopists. This is a paradoxical situation whereby an initially obscure offshoot of ESD to treat a rare and rather esoteric motility disorder is now driving adoption of the parent technique along with the entire field of “new NOTES” procedures. This has led to a pathway to new NOTES in the United States which, as we shall see, has unique features that distinguish it from that seen in Asia.

Introduction

Because the cornerstone of new natural orifice translumenal endoscopic surgery (NOTES) procedures is endoscopic submucosal dissection (ESD), the parent procedure, so to speak, of all new NOTES interventions, Western endoscopists were at a distinct disadvantage compared with their Asian colleagues in the adoption and development of new NOTES procedures. ESD was invented in Japan for en bloc resection of early gastrointestinal (GI) neoplasms, mainly early gastric cancer (found in Asia at approximately 8 times the incidence in the United States), and was widely applied there starting in 2000. For more than a decade, ESD did not gain any significant adoption in the United States. This was in part owing to the scarcity in the West of easy ESD target lesions available in abundance in Asia (early gastric cancer and squamous carcinoma of the esophagus), and the perception of ESD as a time-consuming, technically demanding, difficult to learn, and risky technique without clearly proven benefits over endoscopic mucosal resection in the lesions most common in the West such as colorectal neoplasms. Largely influenced by this negative climate, Olympus and ERBE did not pursue US Food and Drug Administration approval of ESD electrosurgical knives in the United States until 2010, after the advent of peroral endoscopic myotomy (POEM). Most knives became finally commercially available in the United States in 2011. At our center, early ESDs from 2005 to 2011 and POEMs from 2009 to 2011, were performed using a standard non-ESD needle knife resulting in a riskier and less efficient resection. Interestingly, the advent of POEM did, in 2 to 3 years more, to stimulate adoption of ESD in the United States than more than 10 years of favorable publications and demonstrations of ESD by Asian endoscopists. This is a paradoxical situation whereby an initially obscure offshoot of ESD to treat a rare and rather esoteric motility disorder is now driving adoption of the parent technique along with the entire field of “new NOTES” procedures. This has led to a pathway to new NOTES in the United States which, as we shall see, has unique features that distinguish it from that seen in Asia.

The new natural orifice translumenal endoscopic surgery pioneers, an East–West dichotomy

It is instructive to look at the background of POEM pioneers in North America in comparison with that of European and Asian pioneers based in part on data from our international POEM survey conducted in 2012 polling 16 of the 21 pioneering centers in the world at that time. These 16 centers included all high-volume POEM centers at that time (centers with ≥30 cases). All Asian pioneers were surgeons (Inoue, Zhou, Shiwaku, Minami, Chiu) and all but one, Phillip Chiu, came to POEM exclusively from extensive ESD experience rather than NOTES experience. In Europe, early pioneers were almost exclusively gastroenterologists with advanced flexible endoscopy skills, including some ESD experience (Costamagna, Neuhaus, Seewald, Devierre, Fockens, Roesch; one, however, with surgical training as well, Guido Costamagna) with only 1 European POEM pioneer (Karl-Hermann Fuchs) being a surgeon coming to POEM from traditional NOTES experience. In the United States, in stark contradistinction with Asia and Europe, with the exception of our center (Winthrop, Mineola, NY), where the operator is a gastroenterologist with extensive prior ESD experience and no traditional NOTES experience, all other POEM pioneers were surgeons most of whom came to POEM mainly from “traditional NOTES” experience (Swanstrom, Hungness, Marks/Ponsky, Romanelli/Earle/Desilets, Horgan, Ujiki). Table 1 illustrates the rapid growth of POEM in the United States from 1 center in 2009 to 38 centers by the end of 2014. In 27% of these 37 centers, POEM was performed by a gastroenterologist, in 35% by a team composed of a gastroenterologist and a surgeon, and in 38% by a surgeon alone. We venture to speculate that, if in 2009 our center was not the first center in the United States to perform POEM (in fact, the first center to perform POEM outside of the first few cases in Yokohama by Haruhiro Inoue, a foregut surgeon) and do so safely and effectively, POEM and by extension the nascent new NOTES field may have rapidly become the exclusive territory of the surgeon. Based on multiple personal communications with interventional gastroenterologists around the country over the past 5 years, institutional review boards populated in part by traditional surgeons, particularly in major academic centers, regarded the performance of what is essentially minimally invasive thoracic surgery by gastroenterologists with great trepidation. We believe that our early foray into POEM and the excellent initial results supporting the feasibility, efficacy, and safety of POEM performed by a gastroenterologist, as well as our active involvement in proctoring, training, and counseling of both gastroenterologists and surgeons in other institutions (eg, Hopkins, Cornell, Temple, Geisinger, University of California at Irvine, University of Southern California), helped to pave the way for a more equitable participation of gastroenterologists in new NOTES than was the case with traditional NOTES. In this respect, it also helped that as early as March 2011 we were able to demonstrate POEMs performed by a gastroenterologist under the scrutiny of live transmission at our live therapeutic endoscopy course (Long Island Live) followed in subsequent years (2012–2015) by multiple simultaneous live POEMs and live new NOTES subepithelial tumor resections performed in a US endoscopy unit by a gastroenterologist (Stavropoulos) alongside accomplished surgeons (Inoue, Zhou) with comparable procedural facility and outcomes (archived live case videos at www.winthropendoscopy.org ). Another important point that can be easily deduced from Table 1 is that as late as the end of 2014 (>6 years after the first human POEM in Yokohama Japan and >5 years after the first POEM in the United States), only 2 centers had performed more than 150 cases and 10 centers had performed 40 to 80 cases, with the remaining 25 centers at 0 to 30 cases. Thus, based on published data from our group on the learning curve of POEM indicating that competence occurs at 40 procedures and mastery at 60 procedures, most centers were still very early in the learning curve.

From endoscopic submucosal dissection to new natural orifice translumenal endoscopic surgery: a Western experience

Apart from leading the way in POEM adoption in the United States and continuing to possess the highest operator volume for POEMs in the United States, our center is also leading the way in NOTES full-thickness resection of GI tumors with the first endoscopic full-thickness resection (EFTR) and submucosal tunnel endoscopic resection (STER) human cases in the United States performed at our center in 2012 initiating what is still the only reported large Western series of such resections. Our center is also now engaged in developing peroral pyloromyotomy (POP) via a unique interinstitutional collaboration. As such, we briefly review our center’s experience as emblematic of new NOTES development in the United States.

Per Oral Endoscopic Myotomy

POEM represents an aggressive paradigm shift in surgery. Introducing such a procedure in the highly regulated, high medicolegal risk health care environment of the United States and even more egregiously having a gastroenterologist do so in 2009, when the grand total of worldwide publications on POEM consisted of a Digestive Diseases Week video forum abstract from Haruhiro Inoue, required a perfect storm of favorable factors that included (1) extensive prior operator experience in ESD before this became fashionable in the United States, (2) open-minded surgical leadership that provided critical support and advice; (3) an institutional review board that could provide outstanding patient protection while allowing innovation, and (4) stalwart institutional support, including provision of top-notch anesthesia and endoscopy staff, endoscopic equipment, and other resources and research infrastructure, financial support for animal laboratory facilities and live endoscopy activities with Asian NOTES masters, and expert assistance with billing coding and reimbursement issues and negotiations with payers. Fig. 1 demonstrates our gradual methodical progression from ESD to new NOTES procedures of increasing risk and technical complexity. In 2012, we presented data on 89 human ESD cases accumulated between 2008 and 2012 and a study completed in 2011 and 2012 involving 63 ESDs in an acute live animal model in a randomized comparison of 3 knives. The vast majority of POEM operators in the United States after the initial wave of pioneers proceeded to POEM with relatively limited or no ESD experience and no NOTES experience. They sought to develop both POEM and ESD in parallel. This may result in more modest POEM outcomes compared with those of the pioneer group. Of particular concern, however, is the potential increase in severe or life-threatening adverse events, many of which may remain unreported. Recent such events (based on personal communications) that may present the tip of the proverbial iceberg have included septic shock owing to delayed esophagopericardial fistula, empyema, and several cases of severe intratunnel bleeds. Another important finding from our POEM series, which is also seen to a somewhat lesser degree in other US series but does not seem to be shared by most Asian series, is the higher complexity and surgical risk of the cases ( Table 2 ). In our series of 248 patients, 122 patients (49%) were treated previously and in particular 53 (21%) had prior Botox (including patients with up to 18 and 30 Botox treatments), 39 (16%) had prior surgical Heller myotomy (including 3 patients with 2 prior Heller myotomy surgeries each). In addition, 45 of our patients (18%) had end-stage, sigmoid esophagus; 60 (24%) had severe comorbidities and 25 (10%) were older than 80 years old (mean age for the series 54; range, 10–93). These are categories of patients in whom POEM is technically challenging and/or carries a higher surgical risk. In contrast, in the recent publication by Inoue of his series of 500 patients, patients are overall significantly younger by more than a decade (mean age, 43 years old) with very few patients having had prior treatment (Botox 6 patients, 1%; Heller 10 patients, 2%) and a lower proportion of advanced achalasia patients (21 patients [4%] >6 mm diameter and 29 patients [6%] with severe sigmoidization [S2]). These differences result from a number of factors. First, in the United States there was substantial initial resistance to POEM by most gastroenterologists and surgeons, which likely resulted in a referral bias whereby only patients that were poor candidates for Heller myotomy (older, comorbid patients with advanced achalasia, and/or extensive prior therapies including prior Heller) were referred for POEM. During the first years of POEM many of the low-risk/low challenge ideal candidates for POEM who came to our center seeking POEM had discovered POEM on their own through achalasia support groups and then, ignoring the usual advice from their physicians to undergo laparoscopic Heller or other “standard treatments,” would travel great distances to expert POEM centers to have a POEM. For example, at our center, 90 of 248 of our patients (36%) to date traveled to Winthrop from 23 different states and 4 foreign countries ( Fig. 2 ). Second, in contravention to all published guidelines recommending that Botox be reserved for the frail elderly, in the United States, Botox remains unfortunately the most commonly used first-line treatment, despite making subsequent POEM (or Heller myotomy) potentially more complicated. Third, in the United States with its highly distributed decentralized system of health care delivery, many patients with achalasia are being treated in community centers rather than centers of excellence. Given the rarity of achalasia, this results in inexpert management that includes, in addition to inappropriate use of Botox, Heller myotomies performed by surgeons with very limited experience and thus more modest outcomes than those published by centers of excellence. This situation, unfortunately, will also increasingly be the case with POEM as we move from pioneers and early adopters to wider adoption. With the number of POEM centers in the United States now estimated at 60 and increasing rapidly, and the number of achalasia patients who are candidates for POEM by some estimates at only 3000 annually, for many US centers, attaining adequate procedural volumes may be challenging and will get increasingly more so in the future. The outcomes in centers with high-volume operators are similar to the outcomes in our series with success rates remaining greater than 90% beyond 1 year ( Table 3 ) despite the inclusion of many patients who generally respond poorly to any treatment, including POEM, such as sigmoid and severely dilated patients (>6 cm esophageal diameter; accounting for 27% in our series). However, with the inevitable spread of POEM to low-volume centers, outcomes may be more modest, and adverse events, as alluded to previously, may be more severe than the mild, manageable adverse events that have been reported so far by most pioneering US centers including ours ( Table 4 ).

Progression from endoscopic submucosal dissection (ESD) to new natural orifice translumenal endoscopic surgery (NOTES) at Winthrop University Hospital. EFTR, endoscopic full-thickness resection; STER, submucosal tunnel endoscopic resection.

Table 2

Winthrop POEM series baseline patient characteristics

Variable	Value
No. of patients	248
Male	141
Female	107
Age (y), mean	54 (10–93); a 23 patients >80 y old, 2 patients ≥90 y old
Prior achalasia treatment	122 (49%) previously treated a
Pneumatic balloon dilation	33
Suboptimal balloon dilation	57
Botox	53 a (1 treated 18 times, 1 treated 30 times)
Heller myotomy	39 a (3 patients had Heller myotomy 2 times)
POEM	3 a
Esophageal diameter, mean (range)	4.9 cm (2.0–16.9)
Sigmoid esophagus	203 nonsigmoid, 45 sigmoid a
Achalasia stage
I (<3 cm)	34 (14%)
II (3–6 cm)	146 (59%)
III (6–8 cm)	22 (9%) a
IV (>8 cm/sigmoid)	46 (18%; 45/46 all sigmoid, diameter 4–16.9 cm) a
ASA classification
1	18 (7%)
2	170 (69%)
3	60 (24%) a

Abbreviations: ASA, American Society of Anesthesiologists; POEM, per oral endoscopic myotomy.

a High surgical risk and/or high technical challenge categories of patients.

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