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Article ; Online: Upfront Combination Therapy for Pulmonary Arterial Hypertension: Time to Be More Ambitious than AMBITION.

Cascino, Thomas M / McLaughlin, Vallerie V

American journal of respiratory and critical care medicine

2021 Volume 204, Issue 7, Page(s) 756–759

MeSH term(s)	Humans ; Hypertension, Pulmonary/drug therapy ; Pulmonary Arterial Hypertension ; Tadalafil
Chemical Substances	Tadalafil (742SXX0ICT)
Language	English
Publishing date	2021-08-17
Publishing country	United States
Document type	Editorial ; Comment
ZDB-ID	1180953-x
ISSN	1535-4970 ; 0003-0805 ; 1073-449X
ISSN (online)	1535-4970
ISSN	0003-0805 ; 1073-449X
DOI	10.1164/rccm.202107-1625ED
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Article: IMPAHCT: A randomized phase 2b/3 study of inhaled imatinib for pulmonary arterial hypertension.

Gillies, Hunter / Chakinala, Murali M / Dake, Benjamin T / Feldman, Jeremy P / Hoeper, Marius M / Humbert, Marc / Jing, Zhi-Cheng / Langley, Jonathan / McLaughlin, Vallerie V / Niven, Ralph W / Rosenkranz, Stephan / Zhang, Xiaosha / Hill, Nicholas S

Pulmonary circulation

2024 Volume 14, Issue 1, Page(s) e12352

Abstract: AV-101 (imatinib) powder for inhalation, an investigational dry powder inhaled formulation of imatinib designed to target the underlying pathobiology of pulmonary arterial hypertension, was generally well tolerated in healthy adults in a phase 1 single ... ...

Abstract	AV-101 (imatinib) powder for inhalation, an investigational dry powder inhaled formulation of imatinib designed to target the underlying pathobiology of pulmonary arterial hypertension, was generally well tolerated in healthy adults in a phase 1 single and multiple ascending dose study.
Language	English
Publishing date	2024-03-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	2638089-4
ISSN	2045-8940 ; 2045-8932
ISSN (online)	2045-8940
ISSN	2045-8932
DOI	10.1002/pul2.12352
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Article ; Online: Status and Future Directions for Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Disease With and Without Pulmonary Hypertension: A Scientific Statement From the American Heart Association.

Aggarwal, Vikas / Giri, Jay / Visovatti, Scott H / Mahmud, Ehtisham / Matsubara, Hiromi / Madani, Michael / Rogers, Frances / Gopalan, Deepa / Rosenfield, Kenneth / McLaughlin, Vallerie V

Circulation

2024 Volume 149, Issue 15, Page(s) e1090–e1107

Abstract: Balloon pulmonary angioplasty continues to gain traction as a treatment option for patients with chronic thromboembolic pulmonary disease with and without pulmonary hypertension. Recent European Society of Cardiology guidelines on pulmonary hypertension ... ...

Abstract	Balloon pulmonary angioplasty continues to gain traction as a treatment option for patients with chronic thromboembolic pulmonary disease with and without pulmonary hypertension. Recent European Society of Cardiology guidelines on pulmonary hypertension now give balloon pulmonary angioplasty a Class 1 recommendation for inoperable and residual chronic thromboembolic pulmonary hypertension. Not surprisingly, chronic thromboembolic pulmonary hypertension centers are rapidly initiating balloon pulmonary angioplasty programs. However, we need a comprehensive, expert consensus document outlining critical concepts, including identifying necessary personnel and expertise, criteria for patient selection, and a standardized approach to preprocedural planning and establishing criteria for evaluating procedural efficacy and safety. Given this lack of standards, the balloon pulmonary angioplasty skill set is learned through peer-to-peer contact and training. This document is a state-of-the-art, comprehensive statement from key thought leaders to address this gap in the current clinical practice of balloon pulmonary angioplasty. We summarize the current status of the procedure and provide a consensus opinion on the role of balloon pulmonary angioplasty in the overall care of patients with chronic thromboembolic pulmonary disease with and without pulmonary hypertension. We also identify knowledge gaps, provide guidance for new centers interested in initiating balloon pulmonary angioplasty programs, and highlight future directions and research needs for this emerging therapy.
MeSH term(s)	Humans ; Hypertension, Pulmonary/diagnosis ; Hypertension, Pulmonary/etiology ; Hypertension, Pulmonary/therapy ; Pulmonary Embolism/complications ; Pulmonary Embolism/therapy ; American Heart Association ; Chronic Disease ; Angioplasty, Balloon ; Pulmonary Artery ; Thromboembolism ; Endarterectomy
Language	English
Publishing date	2024-03-07
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	80099-5
ISSN	1524-4539 ; 0009-7322 ; 0069-4193 ; 0065-8499
ISSN (online)	1524-4539
ISSN	0009-7322 ; 0069-4193 ; 0065-8499
DOI	10.1161/CIR.0000000000001197
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Article ; Online: Safety of Macitentan for the Treatment of Portopulmonary Hypertension: Real-World Evidence from the Combined OPUS/OrPHeUS Studies.

Kim, Nick H / Chin, Kelly M / McLaughlin, Vallerie V / DuBrock, Hilary / Restrepo-Jaramillo, Ricardo / Safdar, Zeenat / MacDonald, Gwen / Martin, Nicolas / Rosenberg, Daniel / Solonets, Maria / Channick, Richard

Pulmonary therapy

2024 Volume 10, Issue 1, Page(s) 85–107

Abstract: Introduction: Portopulmonary hypertension (PoPH) carries a worse prognosis than other forms of pulmonary arterial hypertension (PAH). Data regarding use of PAH-specific therapies in patients with PoPH are sparse as they are usually excluded from ... ...

Abstract	Introduction: Portopulmonary hypertension (PoPH) carries a worse prognosis than other forms of pulmonary arterial hypertension (PAH). Data regarding use of PAH-specific therapies in patients with PoPH are sparse as they are usually excluded from clinical trials. This analysis describes patient characteristics, treatment patterns, outcomes, and safety profiles in patients with PoPH newly initiating macitentan in the USA using the OPUS/OrPHeUS combined dataset. Methods: OPUS was a prospective, US, multicenter, observational drug registry (April 2014-June 2020); OrPHeUS was a retrospective, US, multicenter chart review (October 2013-March 2017). Additional information regarding patients' liver disease was retrospectively collected for patients with PoPH in OPUS. Results: The OPUS/OrPHeUS dataset included 206 patients with PoPH (median age 58 years; 52.4% female), with baseline cirrhosis and liver test abnormalities reported in 72.8% and 31.6% of patients respectively. Macitentan was initiated as combination therapy in 74.8% of patients and median (Q1, Q3) exposure to macitentan was 11.9 (3.1, 26.0) months. One-year Kaplan-Meier estimates (95% confidence limit, CL) of patients free from all-cause hospitalization and survival were 48.6% (40.7, 56.0) and 82.2% (75.1, 87.4). Of the 96 patients with PoPH in OPUS, 29.2% were classified as in need of liver transplant due to underlying liver disease during the study; transplant waitlist registration was precluded because of PAH severity for 32.1% and 17.9% were transplanted. Hepatic adverse events (HAE) were experienced by 49.0% of patients; the most common being increased bilirubin (16.0%), ascites (7.3%), and hepatic encephalopathy (5.8%); 1.5% and 21.8% of patients discontinued macitentan as a result of HAE and non-hepatic adverse events. Conclusion: There were no unexpected safety findings in patients with PoPH treated with macitentan. These data add to the evidence supporting the safety and tolerability of macitentan in patients with PoPH. A graphical abstract is available with this article. Trial registration: OPsumit® Users Registry (OPUS): NCT02126943; OPsumit® Historical Users cohort (OrPHeUS): NCT03197688; www. Clinicaltrials: gov .
Language	English
Publishing date	2024-01-07
Publishing country	United States
Document type	Journal Article
ISSN	2364-1746
ISSN (online)	2364-1746
DOI	10.1007/s41030-023-00251-x
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Article: Macitentan in Pulmonary Arterial Hypertension Associated with Connective Tissue Disease (CTD-PAH): Real-World Evidence from the Combined OPUS/OrPHeUS Dataset.

Channick, Richard / Chin, Kelly M / McLaughlin, Vallerie V / Lammi, Matthew R / Zamanian, Roham T / Turricchia, Stefano / Ong, Rose / Mitchell, Lada / Kim, Nick H

Cardiology and therapy

2024

Abstract: Introduction: Data on real-world clinical practice and outcomes of patients with pulmonary arterial hypertension associated with connective tissue disease (CTD-PAH) are scarce. The OPUS/OrPHeUS studies enrolled patients newly initiating macitentan, ... ...

Abstract	Introduction: Data on real-world clinical practice and outcomes of patients with pulmonary arterial hypertension associated with connective tissue disease (CTD-PAH) are scarce. The OPUS/OrPHeUS studies enrolled patients newly initiating macitentan, including those with CTD-PAH. This analysis describes patient characteristics, treatment patterns, outcomes, and safety profiles of patients with CTD-PAH newly initiating macitentan in the US using the OPUS/OrPHeUS combined dataset. Methods: OPUS was a prospective, US, multicenter, long-term, observational drug registry (April 2014-June 2020). OrPHeUS was a retrospective, US, multicenter medical chart review (October 2013-March 2017). The characteristics, treatment patterns, safety, and outcomes during macitentan treatment of patients with CTD-PAH and its subgroups systemic sclerosis (SSc-PAH), systemic lupus erythematosus (SLE-PAH), and mixed CTD (MCTD-PAH) were descriptively compared to patients with idiopathic/heritable PAH (I/HPAH). Results: The combined OPUS/OrPHeUS population included 2498 patients with I/HPAH and 1192 patients with CTD-PAH (708 SSc-PAH; 159 SLE-PAH; 124 MCTD-PAH, and 201 other CTD-PAH etiologies). At macitentan initiation for patients with I/HPAH and CTD-PAH, respectively: 61.2 and 69.3% were in World Health Organization functional class (WHO FC) III/IV; median 6-min walk distance was 289 and 279 m; and 58.1 and 65.2% received macitentan as combination therapy. During follow-up, for patients with I/HPAH and CTD-PAH, respectively: median duration of macitentan exposure observed was 14.0 and 15.8 months; 79.0 and 83.0% experienced an adverse event; Kaplan-Meier estimates (95% confidence limits [CL]) of patients free from all-cause hospitalization at 1 year were 60.3% (58.1, 62.4) and 59.3% (56.1, 62.3); and Kaplan-Meier estimates (95% CL) of survival at 1 year were 90.5% (89.1, 91.7) and 90.6% (88.6, 92.3). Conclusions: Macitentan was used in clinical practice in patients with CTD-PAH and its subgroups, including as combination therapy. The safety and tolerability profile of macitentan in patients with CTD-PAH was comparable to that of patients with I/HPAH. Trial registration: OPsumit® Users Registry (OPUS): NCT02126943; Opsumit® Historical Users cohort (OrPHeUS): NCT03197688; www. Clinicaltrials: gov Graphical abstract available for this article.
Language	English
Publishing date	2024-03-07
Publishing country	England
Document type	Journal Article
ZDB-ID	2700626-8
ISSN	2193-6544 ; 2193-8261
ISSN (online)	2193-6544
ISSN	2193-8261
DOI	10.1007/s40119-024-00361-w
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Article ; Online: An overview of the 6th World Symposium on Pulmonary Hypertension.

Galiè, Nazzareno / McLaughlin, Vallerie V / Rubin, Lewis J / Simonneau, Gerald

The European respiratory journal

2019 Volume 53, Issue 1

MeSH term(s)	Antihypertensive Agents ; Humans ; Hypertension, Pulmonary
Chemical Substances	Antihypertensive Agents
Language	English
Publishing date	2019-01-24
Publishing country	England
Document type	Editorial ; Comment
ZDB-ID	639359-7
ISSN	1399-3003 ; 0903-1936
ISSN (online)	1399-3003
ISSN	0903-1936
DOI	10.1183/13993003.02148-2018
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Article ; Online: Exercise Rehabilitation is Underutilized Among Veterans With Pulmonary Hypertension.

Cascino, Thomas M / Schopfer, David W / Meyer, Craig S / Zhang, Ning / Barnes, Geoffrey D / McLaughlin, Vallerie V / Jackson, Elizabeth A / Whooley, Mary A

The American journal of cardiology

2023 Volume 207, Page(s) 4–6

MeSH term(s)	Humans ; Hypertension, Pulmonary ; Veterans ; Exercise Therapy ; Exercise ; Exercise Tolerance ; Quality of Life
Language	English
Publishing date	2023-09-18
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, N.I.H., Extramural
ZDB-ID	80014-4
ISSN	1879-1913 ; 0002-9149
ISSN (online)	1879-1913
ISSN	0002-9149
DOI	10.1016/j.amjcard.2023.08.095
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Article ; Online: Sex, Racial, and Geographic Disparities in Pulmonary Embolism-related Mortality Nationwide.

Zghouzi, Mohamed / Mwansa, Hunter / Shore, Supriya / Hyder, Syed N / Kamdar, Neil / Moles, Victor M / Barnes, Geoffrey D / Froehlich, James / Mclaughlin, Vallerie V / Paul, Timir K / Rosenfield, Kenneth / Giri, Jay / Nallamothu, Brahmajee K / Aggarwal, Vikas

Annals of the American Thoracic Society

2023 Volume 20, Issue 11, Page(s) 1571–1577

Abstract: Rationale: ...

Abstract	Rationale:
MeSH term(s)	Female ; Humans ; Male ; Black or African American ; Cohort Studies ; Pulmonary Embolism/mortality ; Retrospective Studies ; United States/epidemiology ; White ; Health Status Disparities
Language	English
Publishing date	2023-08-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	2717461-X
ISSN	2325-6621 ; 1943-5665 ; 2325-6621
ISSN (online)	2325-6621 ; 1943-5665
ISSN	2325-6621
DOI	10.1513/AnnalsATS.202302-091OC
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Article: Using a knowledge translation program to facilitate guideline- and evidence-based patient management: the PAH-QuERI Extension Program.

McLaughlin, Vallerie V / Channick, Richard N / Lynum, Karimah S Bell / Oudiz, Ronald J / Selej, Mona / Tapson, Victor F / Rubin, Lewis J

Pulmonary circulation

2022 Volume 12, Issue 3, Page(s) e12134

Abstract: The Pulmonary Arterial Hypertension-Quality Enhancement Research Initiative Extension Program was designed to support physicians' adherence to pulmonary arterial hypertension (PAH) guidelines. Guidelines were followed in >95% of patients with functional ... ...

Abstract	The Pulmonary Arterial Hypertension-Quality Enhancement Research Initiative Extension Program was designed to support physicians' adherence to pulmonary arterial hypertension (PAH) guidelines. Guidelines were followed in >95% of patients with functional class (FC) II/III, but for only 28.6% of FC IV patients (Month 36). Low adherence was driven by FC IV patients' preference to avoid parenteral treatment.
Language	English
Publishing date	2022-07-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	2638089-4
ISSN	2045-8940 ; 2045-8932
ISSN (online)	2045-8940
ISSN	2045-8932
DOI	10.1002/pul2.12134
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Article: Pulmonary Hypertension in Women.

Franco, Veronica / Ryan, John J / McLaughlin, Vallerie V

Heart failure clinics

2018 Volume 15, Issue 1, Page(s) 137–145

Abstract: Prevalence of pulmonary arterial hypertension (PAH) is higher in women, and the mechanism remains unclear. Prognosis is overall better for female compared with male patients with PAH. Pregnancy is associated with significant risk, mortality, and ... ...

Abstract	Prevalence of pulmonary arterial hypertension (PAH) is higher in women, and the mechanism remains unclear. Prognosis is overall better for female compared with male patients with PAH. Pregnancy is associated with significant risk, mortality, and morbidity in patients with PAH; consensus guidelines recommend against pregnancy and counsel about early termination in these patients. Recent advances in treatment showed improvement in prognosis in small case reports of pregnant patients with PAH, particularly with the early use of parental prostacyclin. Education remains fundamental for women with PAH of childbearing age for pregnancy prevention as well as discussion about birth control methods.
MeSH term(s)	Contraception/methods ; Female ; Humans ; Hypertension, Pulmonary/epidemiology ; Hypertension, Pulmonary/physiopathology ; Hypertension, Pulmonary/therapy ; Pregnancy ; Pregnancy Complications, Cardiovascular/mortality ; Prevalence ; Prognosis ; Risk Adjustment ; Risk Factors
Language	English
Publishing date	2018-10-24
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2212019-1
ISSN	1551-7136
ISSN	1551-7136
DOI	10.1016/j.hfc.2018.08.013
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