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41


Experimental Pilot Study of a Novel Endobronchial Drug Delivery Catheter

Tsukada, Hisashi; Seward, Kirk P; Rafeq, Samaan; Kocher, Olivier; Ernst, Armin
BACKGROUND: An endobronchial infusion catheter introduced through a flexible bronchoscope channel has not been previously described. The aim of this study was to evaluate the technical feasibility of a new device. METHODS: Four porcine models underwent bronchoscopy with the infusion catheter. In the first experiment, methylene blue was injected into airway in volumes of 0.1, 0.3, or 1.0 mL into 2 animals. One animal was killed at 1 hour and the other at 24 hours after the procedure and gross dye diffusion was visually assessed. In the second experiment, a mixture of 80% sterile normal saline and 20% contrast media was injected into the airway in volumes of 0.3, 1.0, and 3.0 mL into 2 animals. One animal was killed at 7 days and the other at 20 days. Histologic evaluations were performed according to a bronchial damage scoring system. RESULTS: There was no perioperative morbidity. In the first experiment, infusion volumes of 0.1, 0.3, and 1.0 mL resulted in dye surrounding 67%+/-29%, 55%+/-17%, and 80%+/-20% of the infusion-site circumference, and longitudinal distribution of 4.0+/-1.7, 8.1+/-4.1, and 18.0+/-3.0 mm each, respectively. In the second experiment, infusion of 0.3 to 3.0 mL resulted in mild injury, inflammation, and hemorrhage/fibrin/thrombus at 7 and 20 days after surgery. CONCLUSIONS: Endobronchial infusion of dye and contrast media by the endobronchial drug delivery catheter showed that the media spread in a dose-dependent manner macroscopically and histologically. Further investigation will be required to assess the catheter as a new tool for localized drug delivery into the airway.
PMCID:4640925
PMID: 26492604
ISSN: 1948-8270
CID: 2507592

A randomised trial of lung sealant versus medical therapy for advanced emphysema

Come, Carolyn E; Kramer, Mordechai R; Dransfield, Mark T; Abu-Hijleh, Muhanned; Berkowitz, David; Bezzi, Michela; Bhatt, Surya P; Boyd, Michael B; Cases, Enrique; Chen, Alexander C; Cooper, Christopher B; Flandes, Javier; Gildea, Thomas; Gotfried, Mark; Hogarth, D Kyle; Kolandaivelu, Kumaran; Leeds, William; Liesching, Timothy; Marchetti, Nathaniel; Marquette, Charles; Mularski, Richard A; Pinto-Plata, Victor M; Pritchett, Michael A; Rafeq, Samaan; Rubio, Edmundo R; Slebos, Dirk-Jan; Stratakos, Grigoris; Sy, Alexander; Tsai, Larry W; Wahidi, Momen; Walsh, John; Wells, J Michael; Whitten, Patrick E; Yusen, Roger; Zulueta, Javier J; Criner, Gerard J; Washko, George R
Uncontrolled pilot studies demonstrated promising results of endoscopic lung volume reduction using emphysematous lung sealant (ELS) in patients with advanced, upper lobe predominant emphysema. We aimed to evaluate the safety and efficacy of ELS in a randomised controlled setting.Patients were randomised to ELS plus medical treatment or medical treatment alone. Despite early termination for business reasons and inability to assess the primary 12-month end-point, 95 out of 300 patients were successfully randomised, providing sufficient data for 3- and 6-month analysis.57 patients (34 treatment and 23 control) had efficacy results at 3 months; 34 (21 treatment and 13 control) at 6 months. In the treatment group, 3-month lung function, dyspnoea, and quality of life improved significantly from baseline when compared to control. Improvements persisted at 6 months with >50% of treated patients experiencing clinically important improvements, including some whose lung function improved by >100%. 44% of treated patients experienced adverse events requiring hospitalisation (2.5-fold more than control, p=0.01), with two deaths in the treated cohort. Treatment responders tended to be those experiencing respiratory adverse events.Despite early termination, results show that minimally invasive ELS may be efficacious, yet significant risks (probably inflammatory) limit its current utility.
PMCID:4826269
PMID: 25837041
ISSN: 1399-3003
CID: 2507602

Results of the ASPIRE endoscopic lung volume reduction trial at study termination [Meeting Abstract]

Come, Carolyn; Abu-Hijleh, Muhanned; Berkowitz, David; Bezzi, Michela; Bhatt, Surya; Cases, Enrique; Chen, Alexander; Cooper, Christopher; Criner, Gerard; Dransfield, Mark; Flandes, Javier; Gildea, Thomas; Gotfried, Mark; Hogarth, Kyle; Kremer, Mordechai; Leeds, William; Liesching, Timothy; Marquette, Charles; Mularski, Richard; Pinto-Plata, Victor; Pritchett, Michael; Rafeq, Samaan; Rubio, Edmundo; Slebos, Dirk-Jan; Stratakos, Grigoris; Walsh, John; Washko, George; Wells, JMichael; Whitten, Patrick; Yusen, Roger; Zulueta, Javier
ISI:000209782501044
ISSN: 1399-3003
CID: 2507632

Macro and microscopic evaluation of paclitaxel delivery in the airway with a novel endobronchial injectable drug delivery catheter [Meeting Abstract]

Tsukada, Hisashi; Entcheva-Dimitrov, Plamena; Seward, Kirk; Rafeq, Samaan; Ernst, Armin
ISI:000209370403050
ISSN: 1399-3003
CID: 2507622

Pharmacokinetics of Paclitaxel Delivery for the Airway by a New Endobronchial Drug Delivery Catheter: Experimental Study [Meeting Abstract]

Tsukada, Hisashi; Entcheva-Dimitrov, Plamena; Seward, Kirk; Rafeq, Samaan; Ernst, Armin
ISI:000326864000084
ISSN: 0012-3692
CID: 2507642

A Dual-Modality Ultrasound (EBUS and EUS) Approach to Diagnose Pulmonary Histoplasmosis [Meeting Abstract]

Mittal, Anuj; Raphael, Jonelle; Tsukada, Hisashi; Hoffner, Eileen; Rafeq, Samaan; Shah, Bhavesh; Kenney, Lawrence
ISI:000326864000181
ISSN: 0012-3692
CID: 2507652

An Unusual Cause for Hypertensive Crisis After Cesarean Section [Meeting Abstract]

Raphael, Jonelle; Mittal, Anuj; Rafeq, Samaan
ISI:000326864001076
ISSN: 0012-3692
CID: 2507662

BRONCHIAL ASSOCIATED LYMPHOID TISSUE (BALT) LYMPHOMA - IS RITUXIMAB ALONE A VIABLE OPTION INSTEAD OF AGGRESSIVE LOCAL THERAPY AND HIGH DOSE CHEMOTHERAPY EVEN IN THE RELAPSED SETTING FOR THIS RATHER RARE ENTITY? [Meeting Abstract]

Sunkara, Rajitha; Lee, David; Schnieder, Douglas; Rafeq, Samaan; Chi, Dorcas
ISI:000339624904348
ISSN: 1556-1380
CID: 2507672

Pulmonary manifestations of relapsing polychondritis

Rafeq, Samaan; Trentham, David; Ernst, Armin
Relapsing polychondritis (RP) is a chronic multisystemic disease characterized by recurrent episodes of cartilage inflammation throughout the body. The lower respiratory tract is involved in 20% to 50% of patients and results in significant morbidity. Effective medical therapies and airway interventions are available in experienced centers; however, no single treatment is curative, and the prognosis of RP with airway disease remains overall guarded.
PMID: 20692543
ISSN: 1557-8216
CID: 2507612

Biomarkers in pulmonary arterial hypertension

Rafeq, S; Shah, A M; Preston, I R
Despite recent advances in medical treatment, pulmonary arterial hypertension (PAH) continues to be associated with high morbidity and mortality. While the diagnosis is established via a right heart catheterisation, current non-invasive measures of disease severity and response to treatment used in clinical practice are the 6-min walk distance and the World Health Organization functional class. Although both parameters correlate with disease severity and prognosis, they have significant limitations. A major shortcoming in assessing PAH is lack of standardised, non-invasive, objective parameters that function as biomarkers to help assess the severity and prognosis of disease and to follow patients' response to treatment. In this article, we will review current knowledge on potential biomarkers associated with diagnosis, prognosis and response to treatment of PAH. Most biomarkers are either being evaluated for potential use in clinical practice, or being used as research tools.
PMID: 19624798
ISSN: 1368-504x
CID: 2526982