Showing papers by "Lewis J. Rubin published in 2020"
Journal Article•
TL;DR: Prostacyclin produces substantial and sustained hemodynamic and symptomatic responses in severe primary pulmonary hypertension and may be useful in the management of some patients with this disease.
Abstract: Study Objective:To determine the efficacy of continuous intravenous infusion of prostacyclin (epoprostenol) in primary pulmonary hypertension. Design:Randomized trial with 8-week treatment...
596 citations
TL;DR: PDN with an intravascular ultrasound catheter was performed without procedure-related adverse events and was associated with a reduction in PVR and increases in 6-min walk distance and daily activity in patients with PAH on background dual or triple therapy.
Abstract: Objectives The aim of this study was to investigate whether therapeutic intravascular ultrasound pulmonary artery denervation (PDN) is safe and reduces pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension (PAH) on a minimum of dual oral therapy. Background Early studies have suggested that PDN can reduce PVR in patients with PAH. Methods TROPHY1 (Treatment of Pulmonary Hypertension 1) was a multicenter, international, open-label trial undertaken at 8 specialist centers. Patients 18 to 75 years of age with PAH were eligible if taking dual oral or triple nonparenteral therapy and not responsive to acute vasodilator testing. Eligible patients underwent PDN (TIVUS System). The primary safety endpoint was procedure-related adverse events at 30 days. Secondary endpoints included procedure-related adverse events, disease worsening and death to 12 months, and efficacy endpoints that included change in pulmonary hemodynamic status, 6-min walk distance, and quality of life from baseline to 4 or 6 months. Patients were to remain on disease-specific medication for the duration of the study. Results Twenty-three patients underwent PDN, with no procedure-related serious adverse events reported. The reduction in PVR at 4- or 6-month follow-up was 94 ± 151 dyn·s·cm−5 (p = 0.001) or 17.8%, which was associated with a 42 ± 63 m (p = 0.02) increase in 6-min walk distance and a 671 ± 1,555 step (p = 0.04) increase in daily activity. Conclusions In this multicenter early feasibility study, PDN with an intravascular ultrasound catheter was performed without procedure-related adverse events and was associated with a reduction in PVR and increases in 6-min walk distance and daily activity in patients with PAH on background dual or triple therapy.
43 citations
University of Paris-Sud1, University of Texas Southwestern Medical Center2, University of California, Los Angeles3, Allegheny General Hospital4, Actelion5, Mater Misericordiae University Hospital6, Imperial College London7, Medical University of Vienna8, University of Michigan9, University of California, San Diego10, Cedars-Sinai Medical Center11, University of Bologna12, Hannover Medical School13
TL;DR: The association between risk profile and long-term outcome and suggest that selexipag treatment may improve risk profile are supported.
Abstract: BACKGROUND Approaches to risk assessment in pulmonary arterial hypertension (PAH) include the noninvasive French risk assessment approach (number of low-risk criteria based on the European Society of Cardiology and European Respiratory Society guidelines) and Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) 2.0 risk calculator. The prognostic and predictive value of these methods for morbidity/mortality was evaluated in the predominantly prevalent population of GRIPHON, the largest randomized controlled trial in PAH. METHODS GRIPHON randomized 1,156 patients with PAH to selexipag or placebo. Post-hoc analyses were performed on the primary composite end-point of morbidity/mortality by the number of low-risk criteria (World Health Organization functional class I-II; 6-minute walk distance >440 m; N-terminal pro-brain natriuretic peptide RESULTS Both the number of low-risk criteria and the REVEAL 2.0 risk category were prognostic for morbidity/mortality at baseline and any time-point during the study. Patients with 3 low-risk criteria at baseline had a 94% reduced risk of morbidity/mortality compared to patients with 0 low-risk criteria and were all categorized as low-risk by REVEAL 2.0. The treatment effect of selexipag on morbidity/mortality was consistent irrespective of the number of low-risk criteria or the REVEAL 2.0 risk category at any time-point during the study. Selexipag-treated patients were more likely to increase their number of low-risk criteria from baseline to week 26 than placebo-treated patients (odds ratio 1.69, p = 0.0002); similar results were observed for REVEAL 2.0 risk score. CONCLUSIONS These results support the association between risk profile and long-term outcome and suggest that selexipag treatment may improve risk profile.
26 citations
Mater Misericordiae University Hospital1, Harvard University2, University of Texas Southwestern Medical Center3, Actelion4, University of Bologna5, Hochschule Hannover6, University of Michigan7, University of California, San Diego8, University of Paris-Sud9, Cedars-Sinai Medical Center10, University Hospital of Giessen and Marburg11, University of Vienna12
1 citations
Journal Article•
TL;DR: Hemodynamic and scintigraphic measurements were made before and 15 to 30 minutes after nifedipin treatment for primary pulmonary hypertension to evaluate the potential value of n ifedipine treatment forPrimary pulmonary hypertension.
Abstract: To evaluate the potential value of nifedipine treatment for primary pulmonary hypertension, hemodynamic and scintigraphic measurements were made before and 15 to 30 minutes after nifedipin...
1 citations
University of Cologne1, Harvard University2, University of Texas Southwestern Medical Center3, Actelion4, Mater Misericordiae University Hospital5, University of Bologna6, University Hospital of Giessen and Marburg7, Hochschule Hannover8, University of Michigan9, University of California, San Diego10, University of Paris-Sud11, Cedars-Sinai Medical Center12, University of Vienna13
1 citations