Journal of Bronchology & Interventional Pulmonology, Journal Year: 2021, Volume and Issue: 28(2), P. 95 - 97
Published: March 23, 2021
The field of interventional and surgical airway procedures has been transformed in the past decade by rapid introduction disruptive exciting new devices. These devices are aimed at facilitating highly technical interventions, improving efficiency logistics procedural suite, and, more fundamentally, patient safety, outcomes. Despite these noble intentions, many technological advances have introduced with little or no human data, as efficacy safety were deemed regulatory agencies comparable to already widely used clinically. Thus, given paucity data available, clinicians who consider adopting a technique purchasing device need rely on postmarketing, anecdotal, often non–peer-reviewed evidence inform their clinical decisions. In this context, presented Benn colleagues, while limited retrospective nature, critical importance.1 With ~160,000 deaths annually United States, lung cancer remains most common cause cancer-associated mortality States worldwide, accounting for than next 3 cancers: colon, breast, prostate.2 While precise elusive, an estimated 10% 15% patients present central obstruction (CAO), resulting debilitating symptoms that may jeopardize ability undergo potentially life-extending quality-of-life-improving treatments.3 Benign CAO, such those seen idiopathic postintubation stenosis, less precisely characterized clinically epidemiologically but arguably account substantial morbidity well.4 CoreCath 2.7S (Medtronic, Plymouth, MN) is novel flexible electrocautery cleared Food Drug Administration (FDA) 2017 electrosurgical cutting coagulation class II through 510(k) pathway. main purported advantages system (1) integration suction channel designed evacuate smoke (and perhaps blood, debulked tissue other debris generated during debulking procedure) (2) its consistent superficial depth penetration which mitigates risk perforation.1 authors report 64 (30 due malignant CAO) performed 53 2 expert pulmonologists, typically combination ablative modalities. Importantly, patency was recovered all cases intra immediately postprocedural complications. study small obvious limitations inherent design, commended providing what, day, only peer-reviewed available interested considering technology care. This last point worth repeating. small, is, writing editorial, device. reason relative lack use FDA pathway, created congress 1976, allows commercialization deemed, upon manufacturer, be safe effective preexisting, "predicate" Remarkably, 90% currently entering US market pathway.5 Devices thus commercialized therefore not bound type detailed approval process companies seeking develop commercialize pharmaceuticals abide by, consist extensive research, review, postmarket monitoring. By contrast, pathway generally require from trials, regulatorily enforced postmarketing surveillance. considerations explain why handful recently arguably, transformative diagnosing treating diseases required high-level (ie, multicenter randomized controlled trials) premarket approval.6–8 expectedly under intense scrutiny burden caused inadequately untested later proved harmful, calling reform, if complete overhaul process. Yet, also been, some respects, successful: overall recall rates low, reviews foster innovation potentially, accessibility life-improving technologies. process, however, shifts responsibility manufacturers several different ways. First, users cannot mistaken assumption "approved" FDA. role merely agreeing manufacturer's claim similar one commercialized. instances, scope indications are, retrospect, substantially different, expose unexpected risks. Seemingly inconsequential broadening approved consequences, case indwelling pleural catheters 510(k)-cleared benign effusions shown associated increased serious infectious complications hepatic hydrothorax.9,10 setting untested, devices, should aware added uncertainty exist; level detail adequate transparency will vary considerably depending considered represent "gray zone" needs further exploration. Second, it incumbent proceduralist ensure competence procedure considered, could perceived peers enough warrant done appropriate oversight research protocol. As increase accessibility, important remember reported experienced proceduralists translated everyone. Careful prospective collection considered. Finally, we agree current improved.5 cases, particular without sometimes seem surprising, change practice they allow. We, community surgeons, demand both methodologically sound premarketing studies funded scenario, quality care improved outcomes, stifling innovation. unprecedented time transforming ways practice, owe much our patients.
Language: Английский
