763
The Future of Interventional Pulmonology Hans J. Lee, MD1
1 Section of Interventional Pulmonology, Division of Pulmonary and
Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland Semin Respir Crit Care Med 2014;35:763–768.
Abstract
Address for correspondence Sixto Arias, MD, Section of Interventional Pulmonology, Division of Pulmonary Disease and Critical Care Medicine, Johns Hopkins University, 1800 Orleans Street, Suite 7125L, Baltimore, MD 21287 (e-mail: [email protected]).
Interventional pulmonology (IP) is a maturing subspecialty of pulmonary medicine focused on advanced diagnostic and therapeutic pulmonary and thoracic medical procedures for a variety of illnesses. This rapidly growing field requires highly specific knowledge and skill sets beyond its parent specialty. While the future of IP will continue to show growth, we postulate on a few upcoming technologies which may influence the field and discuss some of the challenges associated with growth in IP.
Keywords
► interventional pulmonology ► bronchoscopy ► technology
Interventional pulmonology (IP) is a relatively new specialty in chest medicine which emanated from the application of novel instruments and technology for thoracic diseases. IP continues to grow and is now considered a subspecialty of pulmonary medicine with the recent development of a specialty certification examination.1 Recently, major advances in IP are occurring in a shorter time interval (►Fig. 1). This trend will most likely continue with more frequent breakthroughs in research and technology. While the future is often difficult to predict, there are several challenges for IP on the horizon which include the growing pains for a maturing specialty, education of new technology for practitioners/trainees, and unsolved dilemmas such as the management of pulmonary nodules. In this review, we describe emerging technologies (►Table 1) and describe a prediction of the future of the specialty.
Diagnostic Procedures In the advent of the findings of the national lung cancer screening trial, a surge of interest in developing technology which will improve diagnostic information for the management of pulmonary nodules has emerged.2 As with most advances in technology, miniaturization of existing technology is a common theme. Bronchoscopes with smaller diameters and improved visualization capacity are already in existence. Miniature functional bronchoscopes such as the ultra slim 2.8 mm outer diameter with a 1.2 mm diameter instrument working channel (BF-XP60, Olympus, Tokyo, Japan) and experimental scanning fiber endoscopes with a distal tip diameter of 1.6 mm that allow visualization of distal airways are examples of miniaturization that have made great advances in scope
Issue Theme Interventional Pulmonology; Guest Editors: David Feller-Kopman, MD and Lonny Yarmus, DO, FCCP
technology.3 Newer miniature charged coupled device (CCD) video chips drastically improved endoscopic images quality and recently developed CCD sensor achieves high-definition television (HDTV) resolutions and electronic magnification that allows close up observations up to 1.5 times the original image. Advances in light sources have changed the current anatomy of the bronchoscopes. Light emitting diode light sources eliminates the need for fiber optic bundles, reduces energy consumption, and heat transmission. Other specialties in medicine have already made improvements in their video equipment which IP may potentially readapt. In laparoscopic surgery, the use of threedimensional (3D) cameras (Endoeye Flex 3D, Olympus; 3D-TIPCAM Karl Storz, Tuttlingen, Germany) are used to create 3D images, which have showed improvement in precision and surgical performance.4 Transfer of 3D technologies to flexible and rigid bronchoscopy for therapeutic cases may open the possibility of more precise endobronchial interventions and perhaps simplify its use. Recently commercialized flexible bronchoscopes offer improved ergonomics, lightweight materials, and flexible insertion tubes with rotational capabilities that facilities maneuverability. We believe further advances in flexible bronchoscopy may include optimization in the flexion/extension capabilities, hydrophobic lenses to maintain a clear view without suctioning, telescopic functions, and incorporation of other technology (i.e., ultrasound, microscopy, and navigational capabilities).
Interventional Pulmonology Education The first American IP fellow graduated in 1998 from the Lahey Clinic (Burlington, MA). At present, there are 28 IP fellowship
Copyright © 2014 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA. Tel: +1(212) 584-4662.
DOI http://dx.doi.org/ 10.1055/s-0034-1395506. ISSN 1069-3424.
Downloaded by: Scott Memorial Library, AISR. Copyrighted material.
Sixto Arias, MD1
Future of Interventional Pulmonology
Arias, Lee
HIPPOCRATES AIRWAY IKEDA'S FLEXIBLE CANNULATION BRONCHOSCOPE
300 BC
1897
1966
KILLIAN'S BRONCHOSCHOPY
VIDEO BRONCHOSCOPE (CCD)
1980
1987
WANG'S FLEXIBLE TBNA
ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY
RADIAL EBUS
1990
1992
DUMON'S STENT
2003
2005
LINEAR EBUS
Fig. 1 Milestones in interventional pulmonology.
programs listed in the United States and Canada for 2015 by the American Association of Bronchology Interventional Pulmonology/Association of Interventional Pulmonary Program Directors. We will likely continue to see an exponential growth in the number of practitioners and possibly training programs. Like other specialties, there is a geographic disparity in training programs in IP (►Fig. 2). Most IP programs are concentrated on the eastern half of the continental United States. There are no programs oddly on the West Coast and very few on the west of the Mississippi river. Our future predictions are that we will see an influx of training programs which will lead to additional practitioners making IP a more common specialty across the continental United States. Education will likely continue to grow based on didactic and procedural training. Novel teaching instruments are being developed to improve learning. A challenging issue with IP education is how to competently train new procedures to physicians already in practice. Breakthrough technology for IP is occurring more frequently in this century which will likely require most physicians after traditional pulmonary and critical care fellowship graduation
to learn several new procedures in their careers. Medical simulation and other educational tools may be a solution by providing a zero risk environment to replace or amplify real patient experiences. Training on surgical simulators has already demonstrated improved performance.5–9 Modern bronchoscopic simulators now allow for realistic simulation of common diagnostic procedures (endobronchial biopsies, transbronchial needle aspiration [TBNA], bronchoalveolar lavage, brush); however, more simulators are needed to mimic other situations such as managing complications or more complex therapeutic interventions. A systematic review by Kennedy et al concluded that simulation-based bronchoscopy training was associated with significant development of bronchoscopic skills.10 New digital binocular and monocular glasses such as Glass (Mountain View, CA) developed by Google allows implementation of augmented reality on simulation and teaching of different procedures.11,12 During bronchoscopy it could be used to incorporate radiographic images into the bronchoscopic visual field and allow the instructor to literally visualize their student’s point of view.
Table 1 Potential novel technologies with interventional pulmonology applications Scanning fiber endoscope
Lee3
Endoscopic three-dimensional cameras (Endoeye Flex 3D, 3D-TIPCAM)
Olympus (Tokyo, Japan), Karl Storz (Tuttlingen, Germany)
Augmented reality applications (e.g., MITK pille)
German Cancer Research Center (Heidelberg, Germany)12
Exchangeable endoscopic (EUS) needles systems
BNX system, Beacon Endoscopic (Newton, MA)
Flexible EBUS nitinol needles (SonoTip Flex-EN-V1)
Medi-Globe GmbH (Rohrdorf, Germany)
Robotic biopsy device for capsule endoscopy
Kong17
Ultrasound elastography and contrast-enhanced ultrasound
Ying26
Electromagnetic-guided thermal ablation
Narsule27
Electronic disposable pleural manometer
Lee41
Cone-beam computed tomography-generated image
Hohenforst-Schmidt28
Electromagnetic percutaneous needle lung biopsy
Narsule27
Hyperspectral imaging technology
Darwiche29
Biodegradable drug-eluting stents
Chao32
Drug-eluting tunneled pleural catheter
Tremblay43
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Biopsy Techniques Biopsy instruments by flexible bronchoscopy are challenged with the limited dimension of the flexible bronchoscope working channel while obtaining the largest volume of tissue. In addition, endobronchial ultrasound (EBUS)-TBNA requires specialized needles for tissue acquisition. Newer needle material and design are being developed to be able to capture more tissue as seen with a needle side port for EBUS-TBNA which has been recently released (EchoTip, COOK Medical, Inc., Bloomington, IN). In the lung periphery, flexible nitinol needles are used to make angular turns and steered in the peripheral airway where visualization is not available. A potential solution for additional tissue, cryoprobe transbronchial biopsies provide a significant larger sample when compared with traditional flexible forceps biopsies (fTBBx).13 This technique has been used in the evaluation of interstitial lung diseases, posttransplant lung surveillance for rejection, and peripheral pulmonary nodules sampling.14–16 At present, larger comparative studies are ongoing comparing surgical lung biopsy to fTBBx for the diagnosis of interstitial lung disease. This may potentially change the gold standard for the diagnosis of various interstitial lung diseases. Other novel devices for acquiring larger biopsy samples include a robotic biopsy device that was originally designed for the capsule endoscopy system which could be adapted to obtain pulmonary biopsies; the unit consists of a cylindrical body with an internal rotational biopsy razor to capture a biopsy specimen.17 An evolutionary step forward in diagnostic bronchoscopy may stem from future success of optical biopsy. This would embody pathological information by examining living tissue without an invasive biopsy and this noninvasive method would allow for repeat examinations. Current technologies with microscopic resolution capable to identify dysplastic cells ideally should provide a real-time high quality image sufficient for the clinician to make a diagnosis. Three current technologies which are in development for IP purposes include; optical coherence tomography (OCT), confocal laser endomicroscopy (CLE), and endocytoscopy. OCT uses broad-
band near-infrared light in a process analogous to ultrasonography to image the mucosal and submucosa with a penetration depth of 2 to 3 mm. The structure of the alveoli adjacent to peripheral airways had been imaged using OCT.18 CLE employs blue argon laser light (wavelength 488 nm) to fluoresce the tissue (endobronchium and acinus) and create an image. CLE systems scan a depth of image of 50 μm. A recent study has demonstrated, ex vivo, the ability to distinguish subsets of nonsmall cell lung carcinoma based on imaging characteristics.19 Endocytoscopy is based on the technology of light-contact microscopy requiring a contrast agent to provide subcellular resolution of the bronchial mucosa (magnification up to 1,125).20 Further studies of all these emerging technologies are needed to determine the clinical utility.
Endobronchial Ultrasound TBNA and EBUS-TBNA have been shown to be effective in both the diagnosis and staging of lung cancer.21–23 As miniaturization of bronchoscopic ultrasound technology continues, it may be reasonable to expect further miniaturization with mini-EBUS bronchoscopes with diameters that would allow for real-time visualization and sampling of peripheral lesions. One of the technical challenges during the learning of EBUSTBNA is the transition from 0 degree straight view use in conventional white light bronchoscopy to the 35 degrees seen in most of the EBUS scopes. A newly commercially available EBUS bronchoscope (EB-530 US by Fujifilm, Japan) has a 10 degrees forward oblique optical view and slightly smaller outer diameter as compared with that of the widely popular Olympus EBUS bronchoscope.24 Recent ultrasonographic advances such as elastography and contrast-enhanced (CE) imaging could play a potential role improving the diagnostic capabilities of endobronchial ultrasonography. Ultrasonographic elastography allows quantification of the tissue hardness. This technology is based on the principle that there is less strain when hard tissues are compressed compared with soft tissues.25 Elastography seems to potentially help to select suspicious lymph nodes for biopsy differentiating between Seminars in Respiratory and Critical Care Medicine
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Fig. 2 Number of Interventional pulmonary fellowship training programs by state (2015).
Future of Interventional Pulmonology
Arias, Lee
benign and malignant lymph nodes. In a recent meta-analysis looking at superficial nodes using conventional surface ultrasonography there was a reported pooled sensitivity and specificity for the diagnosis of malignant lymph nodes of 74 and 90% (elasticity scores).26 CE ultrasound is another technique that uses ultrasound contrast agents and traditional ultrasonography to enhance the echogenicity and indirectly provide information on vascularization and perfusion patterns. CE-EBUS could be a potential futuristic modality to optimize imaging acquisition and possibly decrease the need of unnecessary aspirations.
each pixel of a hyperspectral image may contain as many as 700,000 pixels as small as 128 nm each allowing a more detailed characterization of the sample. Micronuclear magnetic resonance is another recently developed technology that allows cellular molecular profiling from fine-needle aspirate samples at the point of care.30 Further investigational advances in this technology may potentially provide a rapid and accurate diagnosis limiting interobserver variability.
Therapeutic Interventions Stents
Navigational Bronchoscopy Navigational bronchoscopy (NB) is used to assist with bronchoscopic biopsies of peripheral nodules and/or fiducial marker placement for stereotactic radiation. In the United States, there are three commercially available systems that use NB for bronchoscopy; i-Logic (Covidien, Minneapolis, MN), LungPoint (Broncus, Mountain View, CA), and SPinDrive (Veran Medical Technologies, St. Louis, MO). While all three offer novel methods for reaching peripheral nodules and tumors, their future application may be the most promising. Future ablative catheters (i.e., microwave, laser) using NB for guided placement may be a potential treatment alternative to surgery or stereotactic radiation. In addition to NB, the Veran system allows for electromagnetic percutaneous needle lung biopsy by using sensored needles to perform peripheral pulmonary nodule lung biopsies.27 This would be most similar to computed tomography (CT) needle biopsies and provide a combination of bronchoscopic biopsy techniques with transthoracic lung needle biopsy in one single procedure. A potential algorithm using rapid onsite cytology may be to start with EBUS mediastinal staging, followed by a NB, followed by a peripheral nodule lung biopsy. The advantages of this approach may be an increase in overall yield as well as a cost-effective method for managing pulmonary nodules in high-risk patients for carcinoma. Cone-beam CT (CBCT) DynaCT (Siemens AG, Forchheim, Germany) was recently used as another image-guided technique to sample lung nodules. CBCT acquires information using a high-resolution two-dimensional detector creating volumetric CT images. Unlike NB, this would allow for realtime navigation as opposed to virtual navigation with NB. Hohenforst-Schmidt et al studied CBCT for biopsy of incidental solitary pulmonary nodules and reported sensitivity for malignancy of 82% in lesions 2cm (15 3 mm).28
Specimen Processing Conventional nanoscale cellular imaging techniques require significant postcollection processing. Hyperspectral imaging technology with enhanced dark field microscopy generates images with maximum resolution of around 100 nm. CytoViva (CytoViva, Inc., Auburn, AL) is one of the nanoscale optical imaging systems that is being tested for rapid onsite diagnosis of lung cancer.29 Hyperspectral images appear very similar to a traditional optical image with a major difference. When observed via image analysis software, Seminars in Respiratory and Critical Care Medicine
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Traditionally tracheobronchial stents are constructed from metallic or silicone material. Newer materials such as bioabsorbable stents are composed of biodegradable polymers such as polydioxanone and polycaprolactone. These forms of stents are being introduced with the intention to reduce granulation tissue formation, provide temporary support, and explore the possibility of continuous local delivery of chemotherapeutic agents. Mitomycin C and cisplatin have been used in animal models with some success in preventing restenosis.31,32 Other potential agents include sirolimus, everolimus, zotarolimus, and paclitaxel. Clinically bioabsorbable stents have been used for the management of airway stenosis postlung transplant33 and extrinsic airway compression in pediatric populations.34 Recently Zopf et al reported the successful implantation of a biodegradable airway splint in a 2-month old infant. The splint was manufactured using three-dimensional printing technology and CT-image reconstruction to deliver a customized airway splint.35,36 With further technological evolution of materials and construction, significant progress is being made toward the ideal airway stent.
Balloon Dilation Techniques The history of bronchoscopic balloon dilation comes from borrowed technology from vascular medicine. At present, dilatational balloon bronchoplasty is a powerful tool for the endoscopic management of malignant and benign airway stenosis.37,38 Cryotherapy (approximately 40°C) uses low temperatures for local destruction of malignant or benign tissue. Another potential future technology borrowed from vascular medicine again is a combined angioplasty/cryotherapy catheter. Spiliopoulos et al reported the use of a combination probe (angioplasty/cryotherapy) to induce apoptosis in the arterial vascular system using a novel cryoballoon catheter (PolarCath, Boston Scientific, Marlborough, MA).39 A balloon-based catheter with microinjection needles has recently been developed to inject local chemotherapeutic agents to relieve central airway obstruction. Clinical human studies are in progress to assess its efficacy and safety.
Lung Volume Reduction Bronchoscopic lung volume reduction aims to emulate the benefits of lung volume reduction surgery in a less invasive method for severe emphysema.40 There have been several disappointing pivotal clinical trials, however, there are currently three ongoing pivotal clinical trials in the United States.
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Future of Interventional Pulmonology Disclosure Dr. H. J. Lee is a consultant for Veran Medical.
References 1 Sterman D. A remarkable time for the American Association for
2
Pleural Disease The assessment of the pleural space for an expandable versus trapped lung has often been performed with manometry. Recently, a commercially available disposable electronic manometer has been shown to be comparable to traditional forms of manometry which may be cumbersome to construct and maintain.41 Other potential future advances may be identifying biomarkers within pleural effusions which may ultimately predict autopleurodesis. A recent pilot study had identified transforming growth factor-β in malignant pleural effusions as a cause and possible predictor of autopleurodesis in patients with tunneled pleural catheters (TPC).42 A larger study is currently underway to confirm these preliminary findings. Other recent advances include animal studies using drugeluting TPC with silver nitrate to induce autopleurodesis and intrapleural delivery of chemotherapy (e.g., bevacizumab/ cisplatin) and immunomodulators for the management of malignant pleural effusions.43,44
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8
Conclusion Major advances in the field of bronchoscopy and IP had historically occurred every 20 to 50 years. In this century, we are seeing major advances occur more frequently. This trend will most likely continue with advances occurring more frequently due to the exponential growth in research and technology. While this is part of the growth of any specialty, it will also bring new challenges in competent training of physicians especially those outside of formal fellowships regarding how to optimally utilize a combination of different technologies. Other predictions of the future are more difficult as some of the technologies that we have mentioned will not become main stream and others not mentioned may very well be. Other factors that affect the future of the specialty are even more difficult to speculate such as financial reimbursements. In any case, the future of IP remains optimistic with expected future growth from an emerging specialty to a standard specialty.
Acknowledgment None.
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Funding None.
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Bronchology and Interventional Pulmonology. J Bronchology Interv Pulmonol 2012;19(4):265–267 Krochmal R, Arias S, Yarmus L, Feller-Kopman D, Lee H. Diagnosis and management of pulmonary nodules. Expert Rev Respir Med 2014 Aug 23:1–15 Lee CM, Engelbrecht CJ, Soper TD, Helmchen F, Seibel EJ. Scanning fiber endoscopy with highly flexible, 1. mm catheterscopes for wide-field, full-color imaging. J Biophotonics 2010;3(5-6): 385–407 Lusch A, Bucur PL, Menhadji AD, et al. Evaluation of the impact of three-dimensional vision on laparoscopic performance. J Endourol 2014;28(2):261–266 Gallagher AG, Seymour NE, Jordan-Black JA, Bunting BP, McGlade K, Satava RM. Prospective, randomized assessment of transfer of training (ToT) and transfer effectiveness ratio (TER) of virtual reality simulation training for laparoscopic skill acquisition. Ann Surg 2013;257(6):1025–1031 Korndorffer JR Jr, Dunne JB, Sierra R, Stefanidis D, Touchard CL, Scott DJ. Simulator training for laparoscopic suturing using performance goals translates to the operating room. J Am Coll Surg 2005;201(1):23–29 Seymour NE, Gallagher AG, Roman SA, et al. Virtual reality training improves operating room performance: results of a randomized, double-blinded study. Ann Surg 2002;236(4):458–463, discussion 463–464 Stefanidis D, Scerbo MW, Montero PN, Acker CE, Smith WD. Simulator training to automaticity leads to improved skill transfer compared with traditional proficiency-based training: a randomized controlled trial. Ann Surg 2012;255(1):30–37 Price J, Naik V, Boodhwani M, Brandys T, Hendry P, Lam BK. A randomized evaluation of simulation training on performance of vascular anastomosis on a high-fidelity in vivo model: the role of deliberate practice. J Thorac Cardiovasc Surg 2011;142(3): 496–503 Kennedy CC, Maldonado F, Cook DA. Simulation-based bronchoscopy training: systematic review and meta-analysis. Chest 2013; 144(1):183–192 Droiders USA. MedicAR–Surgical Glassware with Augmented Reality at Stanford University Medical Center. Available at: http:// www.droiders.com/en/medicar-surgical-glassware-augmentedreality-stanford-university-medical-center/. Accessed 2014 MITK pille—Mobile medical augmented reality app for the Apple iPad. Available at: http://www.youtube.com/watch?v=T4mbojGbEA&feature=player_embedded. Accessed 2012 Babiak A, Hetzel J, Krishna G, et al. Transbronchial cryobiopsy: a new tool for lung biopsies. Respiration 2009;78(2):203–208 Pajares V, Puzo C, Castillo D, et al. Diagnostic yield of transbronchial cryobiopsy in interstitial lung disease: a randomized trial. Respirology 2014;19(6):900–906 Yarmus L, Akulian J, Gilbert C, et al. Cryoprobe transbronchial lung biopsy in patients after lung transplantation: a pilot safety study. Chest 2013;143(3):621–626 Schuhmann M, Bostanci K, Bugalho A, et al. Endobronchial ultrasound-guided cryobiopsies in peripheral pulmonary lesions: a feasibility study. Eur Respir J 2014;43(1):233–239 Kong K, Yim S, Choi S, Jeon D. A robotic biopsy device for capsule endoscopy. J Med Device 2012;6 Tsuboi M, Hayashi A, Ikeda N, et al. Optical coherence tomography in the diagnosis of bronchial lesions. Lung Cancer 2005;49(3):387–394
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Some of the technologies involved have been readapted into different protocols identifying a specific patient subpopulation (i.e., noncollateral ventilation, high residual volume). These devices include endobronchial valves, nitinol coils, vapor thermal ablation, and instillation of biologic agent (hydrogel foam). None of the previously mentioned emphysema treatments have been approved by the US Food and Drug Administration.
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19 Sorokina A, Danilevskaya O, Averyanov A, et al. Comparative study
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of ex vivo probe-based confocal laser endomicroscopy and light microscopy in lung cancer diagnostics. Respirology 2014;19(6): 907–913 Kumagai Y, Monma K, Kawada K. Magnifying chromoendoscopy of the esophagus: in-vivo pathological diagnosis using an endocytoscopy system. Endoscopy 2004;36(7):590–594 Dasgupta A, Mehta AC. Transbronchial needle aspiration. An underused diagnostic technique. Clin Chest Med 1999;20(1): 39–51 Wang KP, Marsh BR, Summer WR, Terry PB, Erozan YS, Baker RR. Transbronchial needle aspiration for diagnosis of lung cancer. Chest 1981;80(1):48–50 Wang KP, Terry PB. Transbronchial needle aspiration in the diagnosis and staging of bronchogenic carcinoma. Am Rev Respir Dis 1983;127(3):344–347 Xiang Y, Zhang F, Akulian J, Yarmus L, Feller-Kopman D, Wang KP. EBUS-TBNA by a new Fuji EBUS scope (with video). J Thorac Dis 2013;5(1):36–39 Ophir J, Céspedes I, Ponnekanti H, Yazdi Y, Li X. Elastography: a quantitative method for imaging the elasticity of biological tissues. Ultrason Imaging 1991;13(2):111–134 Ying L, Hou Y, Zheng HM, Lin X, Xie ZL, Hu YP. Real-time elastography for the differentiation of benign and malignant superficial lymph nodes: a meta-analysis. Eur J Radiol 2012; 81(10):2576–2584 Narsule CK, Sales Dos Santos R, Gupta A, et al. The efficacy of electromagnetic navigation to assist with computed tomographyguided percutaneous thermal ablation of lung tumors. Innovations (Phila) 2012;7(3):187–190 Hohenforst-Schmidt W, Zarogoulidis P, Vogl T, et al. Cone Beam Computertomography (CBCT) in Interventional Chest Medicine High Feasibility for Endobronchial Realtime Navigation. J Cancer 2014;5(3):231–241 Darwiche K, Zarogoulidis P, Krauss L, et al. “One-stop shop” spectral imaging for rapid on-site diagnosis of lung cancer: a future concept in nano-oncology. Int J Nanomedicine 2013; 8:4533–4542 Ghazani AA, Pectasides M, Sharma A, et al. Molecular characterization of scant lung tumor cells using iron-oxide nanoparticles and micro-nuclear magnetic resonance. Nanomedicine (Lond Print) 2014;10(3):661–668
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31 Zhu GH, Ng AH, Venkatraman SS, et al. A novel bioabsorbable drug-
eluting tracheal stent. Laryngoscope 2011;121(10):2234–2239 32 Chao YK, Liu KS, Wang YC, Huang YL, Liu SJ. Biodegradable
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cisplatin-eluting tracheal stent for malignant airway obstruction: in vivo and in vitro studies. Chest 2013;144(1):193–199 Lischke R, Pozniak J, Vondrys D, Elliott MJ. Novel biodegradable stents in the treatment of bronchial stenosis after lung transplantation. Eur J Cardiothorac Surg 2011;40(3):619–624 Vondrys D, Elliott MJ, McLaren CA, Noctor C, Roebuck DJ. First experience with biodegradable airway stents in children. Ann Thorac Surg 2011;92(5):1870–1874 Zopf DA, Hollister SJ, Nelson ME, Ohye RG, Green GE. Bioresorbable airway splint created with a three-dimensional printer. N Engl J Med 2013;368(21):2043–2045 Zopf DA, Flanagan CL, Wheeler M, Hollister SJ, Green GE. Treatment of severe porcine tracheomalacia with a 3-dimensionally printed, bioresorbable, external airway splint. JAMA Otolaryngol Head Neck Surg 2014;140(1):66–71 Hautmann H, Gamarra F, Pfeifer KJ, Huber RM. Fiberoptic bronchoscopic balloon dilatation in malignant tracheobronchial disease: indications and results. Chest 2001;120(1):43–49 Mayse ML, Greenheck J, Friedman M, Kovitz KL. Successful bronchoscopic balloon dilation of nonmalignant tracheobronchial obstruction without fluoroscopy. Chest 2004;126(2):634–637 Spiliopoulos S, Diamantopoulos A, Katsanos K, Ravazoula P, Karnabatidis D, Siablis D. PolarCath cryoplasty enhances smooth muscle cell apoptosis in a rabbit iliac artery model: an experimental in vivo controlled study. Cryobiology 2011;63(3):267–272 Lee HJ, Shojaee S, Sterman DH. Endoscopic lung volume reduction. An American perspective. Ann Am Thorac Soc 2013;10(6):667–679 Lee HJ, Yarmus L, Kidd DA, et al. Comparison of Pleural Pressure Measuring Instruments. Chest 2014 Shojaee S, Voelkel N, Farkas L, de Wit M, Lee HJ. Transforming growth factor-β1 rise in pleural fluid after tunneled pleural catheter placement: pilot study. J Bronchology Interv Pulmonol 2013;20(4):304–308 Tremblay A, Dumitriu S, Stather DR, Maceachern P, Illanes O, Kelly MM. Use of a drug eluting pleural catheter for pleurodesis. Exp Lung Res 2012;38(9-10):475–482 Du N, Li X, Li F, et al. Intrapleural combination therapy with bevacizumab and cisplatin for non-small cell lung cancer–mediated malignant pleural effusion. Oncol Rep 2013;29(6):2332–2340
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768
The Future of Interventional Pulmonology Hans J. Lee, MD1
1 Section of Interventional Pulmonology, Division of Pulmonary and
Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland Semin Respir Crit Care Med 2014;35:763–768.
Abstract
Address for correspondence Sixto Arias, MD, Section of Interventional Pulmonology, Division of Pulmonary Disease and Critical Care Medicine, Johns Hopkins University, 1800 Orleans Street, Suite 7125L, Baltimore, MD 21287 (e-mail: [email protected]).
Interventional pulmonology (IP) is a maturing subspecialty of pulmonary medicine focused on advanced diagnostic and therapeutic pulmonary and thoracic medical procedures for a variety of illnesses. This rapidly growing field requires highly specific knowledge and skill sets beyond its parent specialty. While the future of IP will continue to show growth, we postulate on a few upcoming technologies which may influence the field and discuss some of the challenges associated with growth in IP.
Keywords
► interventional pulmonology ► bronchoscopy ► technology
Interventional pulmonology (IP) is a relatively new specialty in chest medicine which emanated from the application of novel instruments and technology for thoracic diseases. IP continues to grow and is now considered a subspecialty of pulmonary medicine with the recent development of a specialty certification examination.1 Recently, major advances in IP are occurring in a shorter time interval (►Fig. 1). This trend will most likely continue with more frequent breakthroughs in research and technology. While the future is often difficult to predict, there are several challenges for IP on the horizon which include the growing pains for a maturing specialty, education of new technology for practitioners/trainees, and unsolved dilemmas such as the management of pulmonary nodules. In this review, we describe emerging technologies (►Table 1) and describe a prediction of the future of the specialty.
Diagnostic Procedures In the advent of the findings of the national lung cancer screening trial, a surge of interest in developing technology which will improve diagnostic information for the management of pulmonary nodules has emerged.2 As with most advances in technology, miniaturization of existing technology is a common theme. Bronchoscopes with smaller diameters and improved visualization capacity are already in existence. Miniature functional bronchoscopes such as the ultra slim 2.8 mm outer diameter with a 1.2 mm diameter instrument working channel (BF-XP60, Olympus, Tokyo, Japan) and experimental scanning fiber endoscopes with a distal tip diameter of 1.6 mm that allow visualization of distal airways are examples of miniaturization that have made great advances in scope
Issue Theme Interventional Pulmonology; Guest Editors: David Feller-Kopman, MD and Lonny Yarmus, DO, FCCP
technology.3 Newer miniature charged coupled device (CCD) video chips drastically improved endoscopic images quality and recently developed CCD sensor achieves high-definition television (HDTV) resolutions and electronic magnification that allows close up observations up to 1.5 times the original image. Advances in light sources have changed the current anatomy of the bronchoscopes. Light emitting diode light sources eliminates the need for fiber optic bundles, reduces energy consumption, and heat transmission. Other specialties in medicine have already made improvements in their video equipment which IP may potentially readapt. In laparoscopic surgery, the use of threedimensional (3D) cameras (Endoeye Flex 3D, Olympus; 3D-TIPCAM Karl Storz, Tuttlingen, Germany) are used to create 3D images, which have showed improvement in precision and surgical performance.4 Transfer of 3D technologies to flexible and rigid bronchoscopy for therapeutic cases may open the possibility of more precise endobronchial interventions and perhaps simplify its use. Recently commercialized flexible bronchoscopes offer improved ergonomics, lightweight materials, and flexible insertion tubes with rotational capabilities that facilities maneuverability. We believe further advances in flexible bronchoscopy may include optimization in the flexion/extension capabilities, hydrophobic lenses to maintain a clear view without suctioning, telescopic functions, and incorporation of other technology (i.e., ultrasound, microscopy, and navigational capabilities).
Interventional Pulmonology Education The first American IP fellow graduated in 1998 from the Lahey Clinic (Burlington, MA). At present, there are 28 IP fellowship
Copyright © 2014 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA. Tel: +1(212) 584-4662.
DOI http://dx.doi.org/ 10.1055/s-0034-1395506. ISSN 1069-3424.
Downloaded by: Scott Memorial Library, AISR. Copyrighted material.
Sixto Arias, MD1
Future of Interventional Pulmonology
Arias, Lee
HIPPOCRATES AIRWAY IKEDA'S FLEXIBLE CANNULATION BRONCHOSCOPE
300 BC
1897
1966
KILLIAN'S BRONCHOSCHOPY
VIDEO BRONCHOSCOPE (CCD)
1980
1987
WANG'S FLEXIBLE TBNA
ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY
RADIAL EBUS
1990
1992
DUMON'S STENT
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2005
LINEAR EBUS
Fig. 1 Milestones in interventional pulmonology.
programs listed in the United States and Canada for 2015 by the American Association of Bronchology Interventional Pulmonology/Association of Interventional Pulmonary Program Directors. We will likely continue to see an exponential growth in the number of practitioners and possibly training programs. Like other specialties, there is a geographic disparity in training programs in IP (►Fig. 2). Most IP programs are concentrated on the eastern half of the continental United States. There are no programs oddly on the West Coast and very few on the west of the Mississippi river. Our future predictions are that we will see an influx of training programs which will lead to additional practitioners making IP a more common specialty across the continental United States. Education will likely continue to grow based on didactic and procedural training. Novel teaching instruments are being developed to improve learning. A challenging issue with IP education is how to competently train new procedures to physicians already in practice. Breakthrough technology for IP is occurring more frequently in this century which will likely require most physicians after traditional pulmonary and critical care fellowship graduation
to learn several new procedures in their careers. Medical simulation and other educational tools may be a solution by providing a zero risk environment to replace or amplify real patient experiences. Training on surgical simulators has already demonstrated improved performance.5–9 Modern bronchoscopic simulators now allow for realistic simulation of common diagnostic procedures (endobronchial biopsies, transbronchial needle aspiration [TBNA], bronchoalveolar lavage, brush); however, more simulators are needed to mimic other situations such as managing complications or more complex therapeutic interventions. A systematic review by Kennedy et al concluded that simulation-based bronchoscopy training was associated with significant development of bronchoscopic skills.10 New digital binocular and monocular glasses such as Glass (Mountain View, CA) developed by Google allows implementation of augmented reality on simulation and teaching of different procedures.11,12 During bronchoscopy it could be used to incorporate radiographic images into the bronchoscopic visual field and allow the instructor to literally visualize their student’s point of view.
Table 1 Potential novel technologies with interventional pulmonology applications Scanning fiber endoscope
Lee3
Endoscopic three-dimensional cameras (Endoeye Flex 3D, 3D-TIPCAM)
Olympus (Tokyo, Japan), Karl Storz (Tuttlingen, Germany)
Augmented reality applications (e.g., MITK pille)
German Cancer Research Center (Heidelberg, Germany)12
Exchangeable endoscopic (EUS) needles systems
BNX system, Beacon Endoscopic (Newton, MA)
Flexible EBUS nitinol needles (SonoTip Flex-EN-V1)
Medi-Globe GmbH (Rohrdorf, Germany)
Robotic biopsy device for capsule endoscopy
Kong17
Ultrasound elastography and contrast-enhanced ultrasound
Ying26
Electromagnetic-guided thermal ablation
Narsule27
Electronic disposable pleural manometer
Lee41
Cone-beam computed tomography-generated image
Hohenforst-Schmidt28
Electromagnetic percutaneous needle lung biopsy
Narsule27
Hyperspectral imaging technology
Darwiche29
Biodegradable drug-eluting stents
Chao32
Drug-eluting tunneled pleural catheter
Tremblay43
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Biopsy Techniques Biopsy instruments by flexible bronchoscopy are challenged with the limited dimension of the flexible bronchoscope working channel while obtaining the largest volume of tissue. In addition, endobronchial ultrasound (EBUS)-TBNA requires specialized needles for tissue acquisition. Newer needle material and design are being developed to be able to capture more tissue as seen with a needle side port for EBUS-TBNA which has been recently released (EchoTip, COOK Medical, Inc., Bloomington, IN). In the lung periphery, flexible nitinol needles are used to make angular turns and steered in the peripheral airway where visualization is not available. A potential solution for additional tissue, cryoprobe transbronchial biopsies provide a significant larger sample when compared with traditional flexible forceps biopsies (fTBBx).13 This technique has been used in the evaluation of interstitial lung diseases, posttransplant lung surveillance for rejection, and peripheral pulmonary nodules sampling.14–16 At present, larger comparative studies are ongoing comparing surgical lung biopsy to fTBBx for the diagnosis of interstitial lung disease. This may potentially change the gold standard for the diagnosis of various interstitial lung diseases. Other novel devices for acquiring larger biopsy samples include a robotic biopsy device that was originally designed for the capsule endoscopy system which could be adapted to obtain pulmonary biopsies; the unit consists of a cylindrical body with an internal rotational biopsy razor to capture a biopsy specimen.17 An evolutionary step forward in diagnostic bronchoscopy may stem from future success of optical biopsy. This would embody pathological information by examining living tissue without an invasive biopsy and this noninvasive method would allow for repeat examinations. Current technologies with microscopic resolution capable to identify dysplastic cells ideally should provide a real-time high quality image sufficient for the clinician to make a diagnosis. Three current technologies which are in development for IP purposes include; optical coherence tomography (OCT), confocal laser endomicroscopy (CLE), and endocytoscopy. OCT uses broad-
band near-infrared light in a process analogous to ultrasonography to image the mucosal and submucosa with a penetration depth of 2 to 3 mm. The structure of the alveoli adjacent to peripheral airways had been imaged using OCT.18 CLE employs blue argon laser light (wavelength 488 nm) to fluoresce the tissue (endobronchium and acinus) and create an image. CLE systems scan a depth of image of 50 μm. A recent study has demonstrated, ex vivo, the ability to distinguish subsets of nonsmall cell lung carcinoma based on imaging characteristics.19 Endocytoscopy is based on the technology of light-contact microscopy requiring a contrast agent to provide subcellular resolution of the bronchial mucosa (magnification up to 1,125).20 Further studies of all these emerging technologies are needed to determine the clinical utility.
Endobronchial Ultrasound TBNA and EBUS-TBNA have been shown to be effective in both the diagnosis and staging of lung cancer.21–23 As miniaturization of bronchoscopic ultrasound technology continues, it may be reasonable to expect further miniaturization with mini-EBUS bronchoscopes with diameters that would allow for real-time visualization and sampling of peripheral lesions. One of the technical challenges during the learning of EBUSTBNA is the transition from 0 degree straight view use in conventional white light bronchoscopy to the 35 degrees seen in most of the EBUS scopes. A newly commercially available EBUS bronchoscope (EB-530 US by Fujifilm, Japan) has a 10 degrees forward oblique optical view and slightly smaller outer diameter as compared with that of the widely popular Olympus EBUS bronchoscope.24 Recent ultrasonographic advances such as elastography and contrast-enhanced (CE) imaging could play a potential role improving the diagnostic capabilities of endobronchial ultrasonography. Ultrasonographic elastography allows quantification of the tissue hardness. This technology is based on the principle that there is less strain when hard tissues are compressed compared with soft tissues.25 Elastography seems to potentially help to select suspicious lymph nodes for biopsy differentiating between Seminars in Respiratory and Critical Care Medicine
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Fig. 2 Number of Interventional pulmonary fellowship training programs by state (2015).
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benign and malignant lymph nodes. In a recent meta-analysis looking at superficial nodes using conventional surface ultrasonography there was a reported pooled sensitivity and specificity for the diagnosis of malignant lymph nodes of 74 and 90% (elasticity scores).26 CE ultrasound is another technique that uses ultrasound contrast agents and traditional ultrasonography to enhance the echogenicity and indirectly provide information on vascularization and perfusion patterns. CE-EBUS could be a potential futuristic modality to optimize imaging acquisition and possibly decrease the need of unnecessary aspirations.
each pixel of a hyperspectral image may contain as many as 700,000 pixels as small as 128 nm each allowing a more detailed characterization of the sample. Micronuclear magnetic resonance is another recently developed technology that allows cellular molecular profiling from fine-needle aspirate samples at the point of care.30 Further investigational advances in this technology may potentially provide a rapid and accurate diagnosis limiting interobserver variability.
Therapeutic Interventions Stents
Navigational Bronchoscopy Navigational bronchoscopy (NB) is used to assist with bronchoscopic biopsies of peripheral nodules and/or fiducial marker placement for stereotactic radiation. In the United States, there are three commercially available systems that use NB for bronchoscopy; i-Logic (Covidien, Minneapolis, MN), LungPoint (Broncus, Mountain View, CA), and SPinDrive (Veran Medical Technologies, St. Louis, MO). While all three offer novel methods for reaching peripheral nodules and tumors, their future application may be the most promising. Future ablative catheters (i.e., microwave, laser) using NB for guided placement may be a potential treatment alternative to surgery or stereotactic radiation. In addition to NB, the Veran system allows for electromagnetic percutaneous needle lung biopsy by using sensored needles to perform peripheral pulmonary nodule lung biopsies.27 This would be most similar to computed tomography (CT) needle biopsies and provide a combination of bronchoscopic biopsy techniques with transthoracic lung needle biopsy in one single procedure. A potential algorithm using rapid onsite cytology may be to start with EBUS mediastinal staging, followed by a NB, followed by a peripheral nodule lung biopsy. The advantages of this approach may be an increase in overall yield as well as a cost-effective method for managing pulmonary nodules in high-risk patients for carcinoma. Cone-beam CT (CBCT) DynaCT (Siemens AG, Forchheim, Germany) was recently used as another image-guided technique to sample lung nodules. CBCT acquires information using a high-resolution two-dimensional detector creating volumetric CT images. Unlike NB, this would allow for realtime navigation as opposed to virtual navigation with NB. Hohenforst-Schmidt et al studied CBCT for biopsy of incidental solitary pulmonary nodules and reported sensitivity for malignancy of 82% in lesions 2cm (15 3 mm).28
Specimen Processing Conventional nanoscale cellular imaging techniques require significant postcollection processing. Hyperspectral imaging technology with enhanced dark field microscopy generates images with maximum resolution of around 100 nm. CytoViva (CytoViva, Inc., Auburn, AL) is one of the nanoscale optical imaging systems that is being tested for rapid onsite diagnosis of lung cancer.29 Hyperspectral images appear very similar to a traditional optical image with a major difference. When observed via image analysis software, Seminars in Respiratory and Critical Care Medicine
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Traditionally tracheobronchial stents are constructed from metallic or silicone material. Newer materials such as bioabsorbable stents are composed of biodegradable polymers such as polydioxanone and polycaprolactone. These forms of stents are being introduced with the intention to reduce granulation tissue formation, provide temporary support, and explore the possibility of continuous local delivery of chemotherapeutic agents. Mitomycin C and cisplatin have been used in animal models with some success in preventing restenosis.31,32 Other potential agents include sirolimus, everolimus, zotarolimus, and paclitaxel. Clinically bioabsorbable stents have been used for the management of airway stenosis postlung transplant33 and extrinsic airway compression in pediatric populations.34 Recently Zopf et al reported the successful implantation of a biodegradable airway splint in a 2-month old infant. The splint was manufactured using three-dimensional printing technology and CT-image reconstruction to deliver a customized airway splint.35,36 With further technological evolution of materials and construction, significant progress is being made toward the ideal airway stent.
Balloon Dilation Techniques The history of bronchoscopic balloon dilation comes from borrowed technology from vascular medicine. At present, dilatational balloon bronchoplasty is a powerful tool for the endoscopic management of malignant and benign airway stenosis.37,38 Cryotherapy (approximately 40°C) uses low temperatures for local destruction of malignant or benign tissue. Another potential future technology borrowed from vascular medicine again is a combined angioplasty/cryotherapy catheter. Spiliopoulos et al reported the use of a combination probe (angioplasty/cryotherapy) to induce apoptosis in the arterial vascular system using a novel cryoballoon catheter (PolarCath, Boston Scientific, Marlborough, MA).39 A balloon-based catheter with microinjection needles has recently been developed to inject local chemotherapeutic agents to relieve central airway obstruction. Clinical human studies are in progress to assess its efficacy and safety.
Lung Volume Reduction Bronchoscopic lung volume reduction aims to emulate the benefits of lung volume reduction surgery in a less invasive method for severe emphysema.40 There have been several disappointing pivotal clinical trials, however, there are currently three ongoing pivotal clinical trials in the United States.
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Future of Interventional Pulmonology Disclosure Dr. H. J. Lee is a consultant for Veran Medical.
References 1 Sterman D. A remarkable time for the American Association for
2
Pleural Disease The assessment of the pleural space for an expandable versus trapped lung has often been performed with manometry. Recently, a commercially available disposable electronic manometer has been shown to be comparable to traditional forms of manometry which may be cumbersome to construct and maintain.41 Other potential future advances may be identifying biomarkers within pleural effusions which may ultimately predict autopleurodesis. A recent pilot study had identified transforming growth factor-β in malignant pleural effusions as a cause and possible predictor of autopleurodesis in patients with tunneled pleural catheters (TPC).42 A larger study is currently underway to confirm these preliminary findings. Other recent advances include animal studies using drugeluting TPC with silver nitrate to induce autopleurodesis and intrapleural delivery of chemotherapy (e.g., bevacizumab/ cisplatin) and immunomodulators for the management of malignant pleural effusions.43,44
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Conclusion Major advances in the field of bronchoscopy and IP had historically occurred every 20 to 50 years. In this century, we are seeing major advances occur more frequently. This trend will most likely continue with advances occurring more frequently due to the exponential growth in research and technology. While this is part of the growth of any specialty, it will also bring new challenges in competent training of physicians especially those outside of formal fellowships regarding how to optimally utilize a combination of different technologies. Other predictions of the future are more difficult as some of the technologies that we have mentioned will not become main stream and others not mentioned may very well be. Other factors that affect the future of the specialty are even more difficult to speculate such as financial reimbursements. In any case, the future of IP remains optimistic with expected future growth from an emerging specialty to a standard specialty.
Acknowledgment None.
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Funding None.
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