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Pulmonary Vascular Disease |

An Evidence-Based Screening Algorithm for Pulmonary Arterial Hypertension in Systemic Sclerosis: The DETECT Study

Vallerie McLaughlin*, MD; Gerry Coghlan, MD; Christopher Denton, MD; Ekkehard Gruenig, MD; Diana Bonderman, MD; Oliver Distler, MD; Dinesh Khanna, MD; Ulf Mueller-Ladner, MD; Janet Pope, MD; Madelon Vonk, MD; Martin Doelberg, PhD; Harbajan Chadha-Boreham, PhD; Harald Heinzl, PhD; Daniel Rosenberg, PhD; James Seibold, MD
Author and Funding Information

University of Michigan, Ann Arbor, MI


Chest. 2012;142(4_MeetingAbstracts):809A. doi:10.1378/chest.1387106
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Abstract

SESSION TYPE: Pulmonary Hypertension II

PRESENTED ON: Monday, October 22, 2012 at 04:00 PM - 05:30 PM

PURPOSE: Pulmonary arterial hypertension (PAH) causes substantial mortality and morbidity in systemic sclerosis (SSc). Current PAH screening recommendations result in a high false positive rate whilst the rate of missed diagnoses is unknown. DETECT aimed to develop an evidence-based screening algorithm for PAH in SSc that would limit the number of missed PAH diagnoses.

METHODS: In this prospective, multicenter, cohort study [NCT00706082], adult patients with SSc for >3 years, a diffusing capacity of the lung for carbon monoxide (DLCO) <60% of predicted, and no previous diagnosis of pulmonary hypertension (PH) underwent multiple non-invasive screening tests followed by right heart catheterization (RHC). Univariable and multivariable logistic regression, followed by clinical expert input addressing clinical feasibility was used to select the best discriminatory variables for identifying PAH. These were incorporated into a 2-step screening algorithm.

RESULTS: Of 466 SSc patients, 87 had RHC-confirmed PAH, 58 had other forms of PH and 321 had PH excluded. Six non-echocardiographic screening tests were used in step 1 of the algorithm to determine referral to echocardiography with a high sensitivity (97%) in order to minimize missed PAH diagnoses. The step 1 prediction score and two echocardiographic variables were used in step 2 to determine referral to RHC. The DETECT algorithm with a RHC-referral rate of 62% resulted in 4% PAH missed diagnoses (step 2 specificity 35%). At RHC referral rates of ~40% the DETECT algorithm resulted in 15% PAH missed diagnoses (step 2 specificity 65%) compared with 29% when current ERS/ESC screening recommendations were applied to the DETECT population.

CONCLUSIONS: The DETECT algorithm is a highly discriminatory, flexible and non-invasive screening tool for PAH in SSc, which can reduce missed PAH diagnoses to 4%. Even at a RHC referral rate that is in line with the current guidelines, the missed diagnoses rate was halved.

CLINICAL IMPLICATIONS: These data form the basis for a novel and evidence-based approach to revise PAH screening recommendations in SSc.

DISCLOSURE: Vallerie McLaughlin: Consultant fee, speaker bureau, advisory committee, etc.: VVM has received speaking and/0r consulting fees from Actelion, Bayer, Gilead, and United Therapeutics, Grant monies (from industry related sources): The University of Michigan has received research funding for multicenter trials from Actelion, Novartis, Pfizer, and United Therapeutics

Gerry Coghlan: Consultant fee, speaker bureau, advisory committee, etc.: JG Coghlan has consultancy relationships, received lecture honoraria and/or has received research funding from Actelion, Pfizer, GSK and United Therapeutics., Grant monies (from industry related sources): JG Coghlan has consultancy relationships, received lecture honoraria and/or has received research funding from Actelion, Pfizer, GSK and United Therapeutics.

Christopher Denton: Consultant fee, speaker bureau, advisory committee, etc.: C Denton consultancy relationships, received lecture honoraria and/or has received research funding from Actelion, Pfizer, GSK, Sanofi-Aventis and Novartis., Grant monies (from industry related sources): C Denton consultancy relationships, received lecture honoraria and/or has received research funding from Actelion, Pfizer, GSK, Sanofi-Aventis and Novartis.

Ekkehard Gruenig: Consultant fee, speaker bureau, advisory committee, etc.: E Grunig has received honorariums for consultations and/or speaking at conferences from Actelion, Bayer, Gilead, GSK, Lilly, Milteney, Novartis, Pfizer and Rotex Medica, Grant monies (from industry related sources): Has received funding for clinical trials by Actelion, Bayer, GSK, Encysive, Lilly and Pfizer

Diana Bonderman: Grant monies (from industry related sources): D Bonderman has received grant support from Actelion, Consultant fee, speaker bureau, advisory committee, etc.: D Bonderman has acted as a consultant for Actelion

Oliver Distler: Consultant fee, speaker bureau, advisory committee, etc.: Oliver Distler has consultancy relationship and/or has received research funding from Actelion, Pfizer, Boehringer-Ingelheim, Bayer, Roche, Ergonex, BMS, Sanofi-Aventis, United BioSource Corporation, medac, Biovitrium, Novartis and Active Biotec in the area of potential treatments of scleroderma and its complications. He has received lecture honoraria from Actelion, Pfizer and Ergonex, Grant monies (from industry related sources): Oliver Distler has consultancy relationship and/or has received research funding from Actelion, Pfizer, Boehringer-Ingelheim, Bayer, Roche, Ergonex, BMS, Sanofi-Aventis, United BioSource Corporation, medac, Biovitrium, Novartis and Active Biotec in the area of potential treatments of scleroderma and its complications. He has received lecture honoraria from Actelion, Pfizer and Ergonex

Dinesh Khanna: Consultant fee, speaker bureau, advisory committee, etc.: Dinesh Khanna has consultancy relationships, is on Speakers Bureau, and/or has received research funding from Actelion, BMS, Gilead, Genentech, ISDIN, and United Therapeutics, Grant monies (from industry related sources): Dinesh Khanna has consultancy relationships, is on Speakers Bureau, and/or has received research funding from Actelion, BMS, Gilead, Genentech, ISDIN, and United Therapeutics

Ulf Mueller-Ladner: Grant monies (from industry related sources): Ulf Mueller-Ladner has recieved grant support from Actelion

Janet Pope: Consultant fee, speaker bureau, advisory committee, etc.: J Pope consults for Actelion and Pfizer, Grant monies (from industry related sources): J Pope has reveived research funding from Actelion and Pfizer

Madelon Vonk: Consultant fee, speaker bureau, advisory committee, etc.: MC Vonk has consultancy relationships, received lecture honoraria and/or has received research funding from Actelion, Pfizer, GSK and United Therapeutics, Grant monies (from industry related sources): MC Vonk has consultancy relationships, received lecture honoraria and/or has received research funding from Actelion, Pfizer, GSK and United Therapeutics

Martin Doelberg: Employee: M Doelberg is an employee of Actelion Pharmaceuticals Ltd

Harbajan Chadha-Boreham: Employee: Harbajan Chadha-Boreham is an employee of Actelion Pharmaceuticals Ltd

Harald Heinzl: Grant monies (from industry related sources): H Heinzl has recieved grant support from Actelion and Roche Austria, Consultant fee, speaker bureau, advisory committee, etc.: H Heinzl has recieved consultancy fees from Actelion and Roche Austria

Daniel Rosenberg: Employee: D Rosenberg is an employee of Actelion Pharmaceuticals Ltd

James Seibold: Consultant fee, speaker bureau, advisory committee, etc.: J Seibold has the following relationships regarding development of therapies for cardiopulmonary complications of scleroderma: Actelion - funded research, consultancy; United Therapeutics - funded research consultancy, Pfizer - consultancy; Gilead Sciences - funded research, Bayer - consultancy; Boehringer Ingelheim - consultancy; Sigma Tau - consultancy; FibroGen - consultancy; Sanofi - consultancy; Celgene - consultancy; MedImmune - consultancy; Genentech - consultancy; InterMune - consultancy, Grant monies (from industry related sources): J Seibold has the following relationships regarding development of therapies for cardiopulmonary complications of scleroderma: Actelion - funded research, consultancy; United Therapeutics - funded research consultancy, Pfizer - consultancy; Gilead Sciences - funded research, Bayer - consultancy; Boehringer Ingelheim - consultancy; Sigma Tau - consultancy; FibroGen - consultancy; Sanofi - consultancy; Celgene - consultancy; MedImmune - consultancy; Genentech - consultancy; InterMune - consultancy

No Product/Research Disclosure Information

University of Michigan, Ann Arbor, MI

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