While the complexity of flexible bronchoscopy has increased, standard options for moderate sedation medications have not changed in three decades. There is a need to improve moderate sedation while ...maintaining safety. Remimazolam was developed to address shortcomings of current sedation strategies.
A prospective, double-blind, randomized, multicenter, parallel group trial was performed at 30 US sites. The efficacy and safety of remimazolam for sedation during flexible bronchoscopy were compared with placebo and open-label midazolam.
The success rates were 80.6% in the remimazolam arm, 4.8% in the placebo arm (P < .0001), and 32.9% in the midazolam arm. Bronchoscopy was started sooner in the remimazolam arm (mean, 6.4 ± 5.82 min) compared with placebo (17.2 ± 4.15 min; P < .0001) and midazolam (16.3 ± 8.60 min). Time to full alertness after the end of bronchoscopy was significantly shorter in patients treated with remimazolam (median, 6.0 min; 95% CI, 5.2-7.1) compared with those treated with placebo (13.6 min; 95% CI, 8.1-24.0; P = .0001) and midazolam (12.0 min; 95% CI, 5.0-15.0). Remimazolam registered superior restoration of neuropsychiatric function compared with placebo and midazolam. Safety was comparable among all three arms, and 5.6% of the patients in the remimazolam group had serious treatment-emergent adverse events as compared with 6.8% in the placebo group.
Remimazolam administered under the supervision of a pulmonologist was effective and safe for moderate sedation during flexible bronchoscopy. In an exploratory analysis, it demonstrated a shorter onset of action and faster neuropsychiatric recovery than midazolam.
Transbronchial cryobiopsy (TBC) is increasingly recognized as a potential alternative to surgical lung biopsy (SLB) for the diagnosis of interstitial lung disease (ILD). The goal of this analysis was ...to examine the literature on TBC as it relates to diagnostic utility and safety to provide evidence-based and expert guidance to clinicians.
Approved panelists developed key questions regarding the diagnostic utility and safety of TBC for the evaluation of ILD using the PICO (Population, Intervention, Comparator, Outcome) format. MEDLINE (via PubMed) and the Cochrane Library were systematically searched for relevant literature, which was supplemented by manual searches. References were screened for inclusion, and vetted evaluation tools were used to assess the quality of included studies, to extract data, and to grade the level of evidence supporting each recommendation or statement. Graded recommendations and ungraded consensus-based statements were drafted and voted on using a modified Delphi technique to achieve consensus.
The systematic review and critical analysis of the literature based on four PICO questions resulted in six statements: two evidence-based graded recommendations and four ungraded consensus-based statements.
Evidence of the utility and safety of TBC for the diagnosis of ILD is limited but suggests TBC is safer than SLB, and its contribution to the diagnosis obtained via multidisciplinary discussion is comparable to that of SLB, although the histological diagnostic yield appears higher with SLB (approximately 80% for TBC vs 95% for SLB). Additional research is needed to enhance knowledge regarding utility and safety of TBC, its role in the diagnostic algorithm of ILD, and the impact of technical aspects of the procedure on diagnostic yield and safety.
Background Transbronchial forceps biopsy (FBx) has been the preferred method for obtaining bronchoscopic lung biopsy specimens. Cryoprobe biopsy (CBx) has been shown to obtain larger and higher ...quality samples, but is limited by its inability to retrieve the sample through the working channel of the bronchoscope, requiring the bronchoscope to leave the airway for sample retrieval. Objective We evaluated a novel device using a sheath cryobiopsy (SCBx). This method allows for specimen retrieval through the working channel of the bronchoscope, with the scope remaining inside the airway. Methods This prospective, randomized controlled, single-blinded porcine study compared a 1.1-mm SCBx probe, a 1.9-mm CBx probe, and 2.0-mm FBx forceps. Assessment of histologic accessibility, sample quantity and quality, number of attempts to acquire and retrieve samples, cryoprobe activation time, fluoroscopy activation time, technical feasibility, and complications were compared. Results Samples adequate for standard pathologic processing were retrieved with 82.1% of the SCBx specimens, 82.9%% of the CBx specimens, and 30% of the FBx specimens. The histologic accessibility of both SCBx ( P = .0002) and CBx ( P = .0003) was superior to FBx. Procedure time for FBx was faster than for both SCBx and CBx, but SCBx was significantly faster than CBx ( P < .0001). Fluoroscopy time was lower for both SCBx and CBx compared with FBx. There were no significant bleeding events. Conclusions SCBx is a feasible technique providing a higher quality lung biopsy specimen compared with FBx and can successfully be retrieved through the working channel. Human studies are needed to further assess this technique with additional safety data.
Endoscopic optical coherence tomography (OCT) has emerged as a valuable tool for advancing our understanding of the histomorphology of various internal luminal organs and studying the pathogenesis of ...relevant diseases. To date, this technology affords limited resolving power for discerning subtle pathological changes associated with early diseases. In addition, it remains challenging to access small luminal organs or pass through narrow luminal sections without potentially causing trauma to tissue with a traditional OCT endoscope of a 1-1.5 mm diameter. Here we report an ultracompact (520 µm in outer diameter and 5 mm in rigid length) and super-achromatic microprobe made with a built-in monolithic fiber-optic ball lens, which achieves ultrahigh-resolution (1.7 µm axial resolution in tissue and 6 µm transverse resolution) for endoscopic OCT imaging at 800 nm. Its performance and translational potential are demonstrated by in vivo imaging of a mouse colon, a rat esophagus, and small airways in sheep.
The field of bronchoscopy is advancing rapidly. Minimally invasive diagnostic approaches are replacing more aggressive surgical ones for the diagnosis and staging of lung cancer. Evolving diagnostic ...modalities allow early detection and serve as an adjunct to early treatment, ideally influencing patient outcomes. In this review, we will elaborate on recent bronchoscopic developments as well as some promising investigational tools and approaches in development. We aim to offer a concise overview of the significant advances in the field of advanced bronchoscopy and to put them into clinical context. We will also address potential complications and current diagnostic challenges associated with sampling central and peripheral lung lesions.
Checkpoint inhibitor pneumonitis (CIP) is an immune-related adverse event that can occur after initiation of anti–programmed death 1/programmed death ligand 1 immune checkpoint inhibitor (ICI) ...therapy for the treatment of multiple malignancies, including NSCLC. However, the incidence of CIP has not been previously examined in a population that included both trial-enrolled and non–trial-enrolled patients with advanced NSCLC. Furthermore, risk factors and other clinical characteristics associated with CIP severity are not known. In this study, we retrospectively examined clinical characteristics, incidence, and risk factors for CIP in a cohort of 205 patients with NSCLC, all of whom received anti–programmed death 1/programmed death ligand 1 ICIs. Our results demonstrate a higher incidence of CIP (19%) than previously reported in clinical trials (3%–5%). Our data also suggest that tumor histologic type may be a risk factor for CIP development. We observed a wide range of time to onset of CIP (median 82 days), with high morbidity and mortality associated with higher-grade CIP regardless of degree of immunosuppression. Our data provide new insight into the epidemiology and clinical characteristics of CIP. Further studies are needed to increase CIP pharmacovigilance, improve risk stratification, and refine diagnostic algorithms for the diagnosis and management of this potential life-threatening complication of ICI therapy.
Transthoracic needle biopsy of the lung DiBardino, David M; Yarmus, Lonny B; Semaan, Roy W
Journal of thoracic disease,
12/2015, Letnik:
7, Številka:
Suppl 4
Journal Article
Image guided transthoracic needle aspiration (TTNA) is a valuable tool used for the diagnosis of countless thoracic diseases. Computed tomography (CT) is the most common imaging modality used for ...guidance followed by ultrasound (US) for lesions abutting the pleural surface. Novel approaches using virtual CT guidance have recently been introduced. The objective of this review is to examine the current literature for TTNA biopsy of the lung focusing on diagnostic accuracy and safety.
MEDLINE was searched from inception to October 2015 for all case series examining image guided TTNA. Articles focusing on fluoroscopic guidance as well as influence of rapid on-site evaluation (ROSE) on yield were excluded. The diagnostic accuracy, defined as the number of true positives divided by the number of biopsies done, as well as the complication rate pneumothorax (PTX), bleeding was examined for CT guided TTNA, US guided TTNA as well as CT guided electromagnetic navigational-TTNA (E-TTNA). Of the 490 articles recovered 75 were included in our analysis.
The overall pooled diagnostic accuracy for CT guided TTNA using 48 articles that met the inclusion and exclusion criteria was 92.1% (9,567/10,383). A similar yield was obtained examining ten articles using US guided TTNA of 88.7% (446/503). E-TTNA, being a new modality, only had one pilot study citing a diagnostic accuracy of 83% (19/23). Pooled PTX and hemorrhage rates were 20.5% and 2.8% respectively for CT guided TTNA. The PTX rate was lower in US guided TTNA at a pooled rate of 4.4%. E-TTNA showed a similar rate of PTX at 20% with no incidence of bleeding in a single pilot study available.
Image guided TTNA is a safe and accurate modality for the biopsy of lung pathology. This study found similar yield and safety profiles with the three imaging modalities examined.
In recent years, personalized cancer immunotherapy, especially stratification-driven precision treatments have gained significant traction. However, due to the heterogeneity in clinical cohorts, the ...uncombined analysis of stratification/therapeutics may lead to confusion in determining ideal therapeutic options. We report that the coupled immune stratification and drug repurposing could facilitate identification of therapeutic candidates in patients with lung adenocarcinoma (LUAD). First, we categorized the patients into four groups based on immune gene profiling, associated with distinct molecular characteristics and clinical outcomes. Then, the weighted gene co-expression network analysis (WGCNA) algorithm was used to identify co-expression modules of each groups. We focused on C3 group which is characterized by low immune infiltration (cold tumor) and wild-type EGFR, posing a significant challenge for treatment of LUAD. Five drug candidates against the C3 status were identified which have potential dual functions to correct aberrant immune microenvironment and also halt tumorigenesis. Furthermore, their steady binding affinity against the targets was verified through molecular docking analysis. In sum, our findings suggest that such coupled analysis could be a promising methodology for identification and exploration of therapeutic candidates in the practice of personalized immunotherapy.
Despite advances in technology, the bronchoscopic diagnosis of parenchymal pulmonary lesions (PPLs) remains difficult to achieve. Transbronchial lung cryobiopsy (TLCB) offers the potential for larger ...samples with improved diagnostic yield; however, a paucity of data exists describing its safety and usefulness for the diagnosis of PPL.
What is the safety profile of TLCB for PPL?
An observational, retrospective, multicenter cohort study enrolled patients without endobronchial disease undergoing TLCB of PPL from 2015 through 2019. All procedures were performed using both rigid and flexible bronchoscopy with a flexible cryoprobe. Complication rates, including bleeding and pneumothorax rates, were collected. Bleeding was graded on a scale from 0 (trace) to 4 (requiring surgical intervention) with a grade of ≥ 3 considered clinically significant. Pneumothorax, tube thoracostomy placement, diagnostic yield, and need for subsequent interventions were recorded.
One thousand twenty-four patients underwent TLCB. One hundred eighty-eight patients (18%) experienced bleeding; in 36 patients (3.5%), the bleeding was clinically significant. Sixty-eight patients (6.6%) demonstrated a pneumothorax and 64 patients (6.3%) required drainage with tube thoracostomy. All chest drains were removed within 4 days, and no cases of prolonged air leak occurred. A definitive diagnosis was achieved in 932 patients (91%). Adenocarcinoma (46%) and metastatic disease (21%) were the most common diagnoses.
TLCB showed an acceptable safety profile and diagnostic yield for the evaluation of PPL in this large retrospective cohort. Prospective clinical trials are underway to validate these findings further.
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