Abstract
The transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a new approach to the central neck that avoids an anterior cervical incision. This approach can be performed with endoscopic or robotic assistance and offers access to the bilateral central neck. It has been completed safely in both North American and, even more extensively, international populations. With any new technology or approach, complications during the learning curve, expense, instrument limitations, and overall safety may affect its ultimate adoption and utility. To ensure patient safety, it is imperative to define steps that should be considered by any surgeon or group before adoption of this new approach.
Introduction
A
Laparoscopic and endoscopic techniques for other regions of the body have previously been met with some initial skepticism (7). While the long-term advantages of each have been demonstrated and they have ultimately become the standard of care for some surgical procedures, the initial adoption phase of these techniques may be fraught with increased risks (8). The increased risks during the learning curve of these new procedures need to be understood and appreciated by physicians who are considering offering the approach so that they may offer optimally safe surgery and counsel their patients accordingly. Within the realm of thyroid surgery, multiple non-transoral approaches have been met with limited enthusiasm in the West, despite some international utilization. Complications heretofore not experienced in traditional thyroid surgery, as well as increased technical complexity and cost, are some reasons that may explain this (9). Given this recent experience and in light of the excellent safety profile of the traditional trans-cervical approach, the introduction of novel technologies and surgeries should occur within a rational framework to ensure that patient safety and outcomes are optimized (10 –12).
In 1994, the American College of Surgeon's Committee on Emerging Surgical Technology and Education provided basic principles surrounding the implementation of new techniques and technologies (13). These recommendations were then used in 2010 to examine robotic thyroidectomy, providing surgeons, patients, and institutions with minimum expectations before embracing this new technology (7). While robotic thyroidectomy has not become prevalent in the West, the foundation of careful planning, preparation, consent, and documentation defined therein was established as an expectation during initial exploratory investigations of new technologies and techniques. Additionally, the Idea, Development, Exploration, Assessment, Long-term Follow-up, Improving the Quality of Research in Surgery (IDEAL) recommendations have been established and provide a framework for surgical innovation that has been applied in other disciplines (6).
Early resistance and skepticism to new techniques is common and provides a check on unfounded enthusiasm. Because high-quality evidence is necessarily lacking during the development and adoption phase of a new technique, any implementation requires robust data collection of both implementation and outcome metrics. Such a rational approach informs the decision-making process on all levels, and demonstrates to both patients and the scientific community the dedication to safeguarding patient outcomes. Such an approach not only protects patients, but also prevents against discarding a technique too early that may ultimately prove to be useful in the proper context. Rapid dissemination of a new procedure by surgeons and institutions not fully trained and qualified to perform it may lead to unnecessarily high complication rates that falsely cast the new procedure in a negative light. Only through a thoughtful, measured approach can the hype of novelty be clearly separated from real improvements in the well-being of those for whom we care as physicians, ultimately resulting in better patient outcomes (6,14).
Various surgeons who helped pioneer these procedures and some early adopters of the techniques have collaborated to develop a framework to promote the safe introduction of TOETVA. These surgeons include general surgeons and head and neck surgeons who specialize in thyroid and parathyroid surgery. Some members of this group have previously published recommendations regarding appropriate surgical innovation (7).
Herein, the authors seek to establish the basic framework necessary for what they consider to be safe and responsible implementation, understanding that such recommendations may be applicable to the evaluation and potential integration of other technologies or techniques. Using available literature and author experience, minimum requisites were defined. As has been highlighted previously, the fact that a technique or technology may be available does not imply that it is appropriate (15). This framework allows thoughtful surgeons the ability to determine cautiously how and when implementation of this technique should occur and in what specific clinical context.
Safety, Efficacy, and Quality
Preliminary reports from high-volume thyroid surgeons in Thailand, Korea, Italy, and the United States suggest that TOETVA can be performed safely (1 –4,16). Rates of recurrent laryngeal nerve injury, hypoparathyroidism, and wound infections appear equivalent to the traditional approach. Initial reports have not shown significant increases in serious complications or the complications that accompanied early experience with other remote access site robotic thyroidectomy. However, complications such as skin burns, temporary chin numbness, and oral commissure tears have been reported (5,17,18). While a learning curve is expected with any new procedure, it is important to remember that the standard Kocher incision typically provides excellent aesthetic and safety outcomes in most patients. Careful consideration of the possible risks of a new procedure and fully informing patients of such is our ethical responsibility (15).
While patient safety is preeminent, a thoughtful study of a new technique also requires that surgeons and patients understand what the actual advantages are—that is, are perceived advantages truly advantages? TOETVA primarily offers an aesthetic advantage by eliminating a cervical incision. It is also possible that visualization with the use of high-definition, magnified scopes in the tunneled approach may be superior to the traditional trans-cervical naked-eye view, although this remains speculative at this time. Some authors have suggested that thyroid scars impair quality of life and result in some patients being self-conscious years after their surgery (19,20). It is apparent, however, that the true value of avoiding a cervical incision is not completely understood and may vary among patients and be influenced by cultural and societal contexts. Moving forward, it is incumbent upon surgeons offering the procedure to define the value added to the patient and to society. The patient's right to evaluate the value propositions of all surgical options available once safety is established should also be respected.
Surgeons and institutions must realize the responsibility that comes with the early implementation of new techniques and technology. Timely sharing of early lessons learned may prevent the same mistakes from being repeated by different surgeons. The importance is emphasized of recording, reporting, and responsibly sharing appropriate successes and shortcomings inherent in these techniques, optimally through a shared, compliant, and HIPAA-protected database that is regularly reviewed. Additionally, early efforts must consider the value that remote access thyroidectomy procedures add to society. This will include both any increase in costs associated with novel techniques, as well as the potential perceived or real benefits to patients or society.
Suggested Outline for Exploration of TOETVA
Minimum requirements for implementation of these techniques are suggested in Table 1. The presence of these elements allows rational discussion of the implementation process but may not be sufficient alone. Individualized adaptation to the patient, surgeon, and institution may be required.
Surgeon candidacy
Prior to learning TOETVA, a surgeon must be proficient and credentialed in the standard procedures of the central neck, including thyroidectomy, parathyroidectomy, and central neck dissection (21). While important as a basis for understanding the anatomy and surgical objectives, this is doubly important, as the final pathway in any failed remote access approach is conversion to an open (standard) approach. Recent literature has suggested that a specific number of thyroidectomies completed annually differentiate high-volume surgeons and are associated with improved outcomes. However, there was no consensus among the authors to determine a requisite number of open thyroidectomies in order to perform transoral thyroid surgery (21).
Surgeon requirements are: high-volume thyroid practice (21); demonstrated competence with necessary instrumentation; and, for robotic cases, surgeons must be facile and credentialed for robotic instrumentation. Some authors suggest that surgeons should be experienced robotic surgeons before beginning TORTVA.
Education and preparation
Prior to beginning, institutional support must be in place. This may entail discussions within surgical departments, administrative leads, and risk management. While initial roll-out of a new surgical procedure does not require Institutional Review Board approval (15), it is mandatory if patient data will be used in research and publication, which research is strongly encouraged. Institutional support ensures that risks are minimized, resources are available, and teams of qualified assisting personnel may be recruited. Furthermore, such support ensures that early efforts, where risks to patients are greatest, are not pursued independently and without plans for a rational evaluation that extends beyond the initial learning curve. Such support will necessarily include expressed support of some or all of the following: department or division chairs, credentialing committees, risk management and medicolegal, ethics, nursing leadership, operating room technicians, and the anesthesia team.
Once institutional support has been obtained, individual and team preparation begins (Table 2). As for established procedures, the learning curve for this procedure should be under the close supervision of a senior high-volume surgeon. To ensure patient safety, adequate preparation is vital. Familiarity with the existing literature is necessary to identify anticipated surgical steps and potential complications. Videos are readily available as well and may be beneficial (22).
Instrument preparation and familiarity is a foundational step in the process, and obtaining necessary instrumentation and confirming that it is in proper working order prior to performing the procedure is essential. Operating room personnel should be involved early in the discussions and preparation of cases, and a “dry run” with all steps executed is recommended to limit distractions and problems for the first live cases. Defining key personnel (nurses, surgical assistants, etc.) to participate in the earliest cases will ensure that these repetitions optimize safety and lead to efficiency over time. Even though it is mandatory that the primary surgeon be a high-volume thyroid surgeon, it is also optimal to proceed with a second experienced thyroid co-surgeon. If this team approach of two experienced surgeons is not possible, a minimum expectation is that the first assistant will be familiar with the surgeon, technique, and anatomy.
Once the educational aspect, including familiarity with the literature, videos, and live observations (of at least two cases by surgeons with experience in the procedure), has been completed, cadaveric simulations should be considered. If possible, it is recommended that at least two cadaveric dissections be completed to ensure familiarity with the operative technique and equipment. Educational courses and simulations may offer some value but are likely not sufficient in isolation. It is acknowledged that these recommendations are not evidence based but represent the consensus opinion of the authors.
Although the surgeon is ultimately responsible for patient safety, communication between all team members is critical. Because the procedure is not familiar to most, the need for proctoring during the earliest cases is again reinforced, as the proctor may be best equipped to suggest when conversion is necessary. Several examples should include blood loss that impairs visualization and is refractory to remote access attempts at control, inadequate visualization of critical structures such as the trachea, equipment malfunction that reduces patient safety, tracheal injury, and suspected injury to other vital organs such as the carotid artery or esophagus. Additional examples for conversion to an open approach would be unexpected intraoperative findings warranting an open approach for complete evaluation and treatment or anatomic abnormalities that impair remote visualization. This must also be discussed with the patient in detail prior to the surgery so that patients have reasonable expectations and understand that their safety is always first and foremost.
The final step is to have direct on-site or remote but real-time precepting by an experienced transoral vestibular approach surgeon during the initial learning curve and prior to proceeding independently. In the authors’ experience, such availability is critical to ensure patient safety and surgeon peace of mind.
Responsibilities to surgical and patient communities
As stated previously, the implementation of new technologies and procedures carries a burden of transparent and timely reporting of outcomes to protect patient and surgical communities. The most apparent of these is routine collection of surgical outcomes and complications. While it is understood that not all surgeons will do so with the intent of publishing their results, the systematic collation of outcomes from multiple surgeons will allow for observation and rapid response to trends or pitfalls that may arise (6). Communication between surgeons and other centers of excellence is expected in the earliest days of this technique. Table 3 defines expected minimum data points that should be collected and reviewed regularly. Mechanisms for reporting adverse outcomes must be established, and such outcomes must be shared among the surgical community immediately through rapid publication, membership in registries, or direct communication when the complications are severe and may be relevant to future surgeons.
BMI, body mass index; OR, operating room.
Patient selection and the informed consent process
The appropriate first patient will be highly motivated to avoid a cervical incision. If considering thyroid lobectomy, the patient should have benign or indeterminate thyroid pathology and a relatively small nodule (i.e., <4 cm) that is favorably located. There may be some advantages in considering a thyroid lobectomy alone for the first few procedures. Similar to performing a first open thyroidectomy, for example, prudence should guide the selection of the first patient for the transoral vestibular approach. The patient must fully understand the novel nature of this procedure, including the experience, or lack thereof, of the surgical team. Such open dialogue is paramount in establishing the trust and fidelity that is necessary in the surgeon–patient relationship, upon which the informed consent process relies (15).
Conclusions
TOETVA is now an option for patients motivated to avoid a cervical incision. The significance and durability of this cosmetic advantage has not been well studied, and its ultimate merit is still unproven. Additional study is required to determine its equivalency to the standard and well-tolerated trans-cervical thyroidectomy. Given this, it is essential that its initial application be performed with optimal transparency and, above all, optimal patient safety. The above recommendations for training and implementation serve as a framework of minimum requirements for interested surgeons. While these suggestions are not evidence based, they do represent the consensus of some early adopters of this technique. Ultimate responsibility falls to each individual hospital, surgeon, and patient to determine the appropriateness in each situation, but each surgeon maintains additional responsibility to the surgical community to prepare and report their outcomes. While new technologies and approaches should be encouraged, a rational and thoughtful approach ensures optimal outcomes and prompt recognition of potential limitations.
Footnotes
Author Disclosure Statement
No competing financial interests exist.