Standardized Goal-Directed vs. Self-Directed Valsalva Maneuver for the Assessment of Patent Foramen Ovale

Overview

Ischemic stroke represents a major public health issue, leading to significant disabilities and deaths worldwide. When no clear cause for stroke is found following a comprehensive cardiovascular evaluation (no atrial fibrillation, cardiac masses, or atherosclerosis) i.e. cryptogenic stroke, it is recommended to search for a patent foramen ovale (PFO), especially in young patients. It is estimated that cryptogenic stroke accounts for 30% to 40% of ischemic strokes. Transthoracic echocardiography (TTE) with bubble study at rest and during Valsalva maneuver is the reference method for the diagnosis of PFO. The treatment of PFO using a closure device has demonstrated a significant reduction in recurrent stroke events in patients with PFO and cryptogenic stroke. The Valsalva maneuver is currently achieved using self-directed maneuver i.e. patients are instructed to ''bear down'' or ''strain as if attempting to move your bowels.'' These instructions are subjective and depend largely on individuals understanding and effort. A Goal-Directed Valsalva Maneuver using a manometer has been shown to be a more reproducible way to perform the Valsalva achieving more sensitivity in different settings such as hypertrophic cardiomyopathy but its incremental diagnostic value for the detection of PFO has not been yet evaluated. The aim of the present study is to compare the sensibility and specificity of two methods of Valsalva maneuver for the detection of PFO. We hypothesize that Goal-Directed Valsalva Maneuver will significantly increase the detection rate of PFO compared to Self-Directed Valsalva Maneuver.

Interventions

• Device Experimental: Intervention arm: Goal-Directed Valsalva maneuver
  For the Goal directed Valsalva maneuver, the same method patients are instructed to blow into a plastic pipe connected to the manometer device, in order to reach a pressure of 40 mmHg for at least 5 seconds. Then patients are instructed to exhale quickly.
• Device Control - standard of care: Self-Directed Valsalva maneuver
  The Valsalva maneuver is performed by the patient taking a normal (or deep) inspiration, followed by forceful expiration against a closed airway for up to 15 to 20 sec and then release of the expiratory effort on entry of saline into the right atrium.

Primary outcome measures

• Rate of detection of PFO by Self-Directed Valsalva Maneuver and Goal-Directed Valsalva Maneuver. [Time frame: From enrollment to the end of echocardiogram (40 minutes from enrollment).]

Secondary outcome measures (2)

• Rate of large shunt positive bubble study. [Time frame: From enrollment to the end of echocardiogram (40 minutes from enrollment).]
• Rate of detection of PFO by Self-Directed Valsalva Maneuver and Goal-Directed Valsalva Maneuver in women and in men. [Time frame: From enrollment to the end of echocardiogram (40 minutes from enrollment).]

Eligibility criteria

Inclusion criteria

• Patients referred for a clinically indicated TTE and bubble study

Exclusion criteria

• Inability to provide informed consent
• Inability to insert an IV line
• Inability to perform a Self-Directed Valsalva maneuver
• Patient wishing to keep his mask on

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Diagnostic

Study locations

Canada · 2 centers

• University of Ottawa Heart Institute — Ottawa
• University of Ottawa Heart Institute — Ottawa

Publications

• Bernard S, Churchill TW, Namasivayam M, Bertrand PB. Agitated Saline Contrast Echocardiography in the Identification of Intra- and Extracardiac Shunts: Connecting the Dots. J Am Soc Echocardiogr. 2020 Oct 23:S0894-7317(20)30615-5. doi: 10.1016/j.echo.2020.09.013. Online ahead of print. PMID 34756394
• Zhao E, Du Y, Xie H, Zhang Y. Modified Method of Contrast Transthoracic Echocardiography for the Diagnosis of Patent Foramen Ovale. Biomed Res Int. 2019 May 9;2019:9828539. doi: 10.1155/2019/9828539. eCollection 2019. PMID 31211145
• Mas JL, Derumeaux G, Guillon B, Massardier E, Hosseini H, Mechtouff L, Arquizan C, Bejot Y, Vuillier F, Detante O, Guidoux C, Canaple S, Vaduva C, Dequatre-Ponchelle N, Sibon I, Garnier P, Ferrier A, Timsit S, Robinet-Borgomano E, Sablot D, Lacour JC, Zuber M, Favrole P, Pinel JF, Apoil M, Reiner P, Lefebvre C, Guerin P, Piot C, Rossi R, Dubois-Rande JL, Eicher JC, Meneveau N, Lusson JR, Bertrand PMID 28902593
• Mojadidi MK, Winoker JS, Roberts SC, Msaouel P, Zaman MO, Gevorgyan R, Tobis JM. Accuracy of conventional transthoracic echocardiography for the diagnosis of intracardiac right-to-left shunt: a meta-analysis of prospective studies. Echocardiography. 2014 Oct;31(9):1036-48. doi: 10.1111/echo.12583. Epub 2014 Apr 2. PMID 24689727
• Saric M, Armour AC, Arnaout MS, Chaudhry FA, Grimm RA, Kronzon I, Landeck BF, Maganti K, Michelena HI, Tolstrup K. Guidelines for the Use of Echocardiography in the Evaluation of a Cardiac Source of Embolism. J Am Soc Echocardiogr. 2016 Jan;29(1):1-42. doi: 10.1016/j.echo.2015.09.011. PMID 26765302
• Cohen A, Donal E, Delgado V, Pepi M, Tsang T, Gerber B, Soulat-Dufour L, Habib G, Lancellotti P, Evangelista A, Cujec B, Fine N, Andrade MJ, Sprynger M, Dweck M, Edvardsen T, Popescu BA; Reviewers: This document was reviewed by members of the 2018-2020 EACVI Scientific Documents Committee; chair of the 2018-2020 EACVI Scientific Documents Committee. EACVI recommendations on cardiovascular imaging PMID 33709114
• Yaghi S, Bernstein RA, Passman R, Okin PM, Furie KL. Cryptogenic Stroke: Research and Practice. Circ Res. 2017 Feb 3;120(3):527-540. doi: 10.1161/CIRCRESAHA.116.308447. PMID 28154102
• Mojadidi MK, Zaman MO, Elgendy IY, Mahmoud AN, Patel NK, Agarwal N, Tobis JM, Meier B. Cryptogenic Stroke and Patent Foramen Ovale. J Am Coll Cardiol. 2018 Mar 6;71(9):1035-1043. doi: 10.1016/j.jacc.2017.12.059. PMID 29495983

Identifiers

NCT: NCT06670781 · OHSN CRRF ID - 6016

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗