Modified Method of Contrast Transthoracic Echocardiography for the Diagnosis of Patent Foramen Ovale

Q: What is the clinical evidence from this study?

Study design: RCT. Population: High clinical suspicion of patent foramen ovale (PFO) (n=506). Intervention: Modified Valsalva maneuver with contrast transthoracic echocardiography (c-TTE) using a handmade pressure monitoring device vs. Traditional Valsalva maneuver (expiration against a closed glottis after a full inspiration) with contrast transthoracic echocardiography. Primary outcome: Diagnostic sensitivity for detecting patent foramen ovale right-to-left shunt (PFO-RLS) compared against contrast transesophageal echocardiography (c-TEE) gold standard (p=0.001).

Enfa Zhao; Yajuan Du; Hang Xie; Yushun Zhang

doi:10.1155/2019/9828539

May 9, 2019BioMed Research InternationalOpen Access

Modified Method of Contrast Transthoracic Echocardiography for the Diagnosis of Patent Foramen Ovale

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Key result

Modified contrast transthoracic echocardiography using a manometer-guided Valsalva maneuver significantly increased PFO diagnostic sensitivity compared to the traditional method (92.83% vs. 83.87%, P=0.001).

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Why the study?

To compare the sensitivity and specificity of modified versus traditional methods of contrast echocardiography of the right portion of the heart in patients with suspected patent foramen ovale.

Does a modified Valsalva maneuver using a pressure monitoring device improve the diagnostic sensitivity and specificity of contrast transthoracic echocardiography for detecting patent foramen ovale compared to the traditional Valsalva maneuver in patients with high clinical suspicion of PFO?

Key Points

To compare the diagnostic sensitivity and specificity of a modified pressure-monitored Valsalva maneuver versus the traditional maneuver during contrast transthoracic echocardiography in patients with suspected patent foramen ovale.
Prospective interventional trial of 506 patients with high clinical suspicion of patent foramen ovale (NCT02777359).
Patients underwent contrast transthoracic echocardiography using the traditional Valsalva maneuver and a modified maneuver with a handmade manometer maintaining a minimum pressure of 40 mmHg.
Contrast transesophageal echocardiography was used as the diagnostic gold standard.
Contrast transesophageal echocardiography confirmed patent foramen ovale with right-to-left shunt in 279 of 506 patients (55.13%).
Modified contrast echocardiography showed significantly higher diagnostic sensitivity than the traditional method (92.83% [259 cases] vs. 83.87% [234 cases], P=0.001), while specificity did not differ significantly (97.35% vs. 96.03%, P=0.431).
Semiquantitative shunt grading revealed no significant difference between the modified and traditional methods (Z=−1.782, P=0.075), and no adverse events occurred during procedures or 12-hour follow-up.

Study Design

Type

RCT (n=506)

Blinding

Single-blind (experienced sonographer blinded to the methods used analyzed findings retrospectively)

Randomization

Random order of performing first either the traditional Valsalva maneuver or the modified Valsalva maneuver with at least a 10-minute interval

Multicenter

No

Structured PICO

Does a modified Valsalva maneuver using a pressure monitoring device improve the diagnostic sensitivity and specificity of contrast transthoracic echocardiography for detecting patent foramen ovale compared to the traditional Valsalva maneuver in patients with high clinical suspicion of PFO?

P

Population

506 consecutive patients in China (mean age 41.49 years, 62.06% female) with high clinical suspicion of patent foramen ovale due to TIA, cryptogenic stroke, migraine headaches, or cerebral infarction of unknown cause, followed for 12 hours post-procedure.

I

Intervention

Modified method of contrast transthoracic echocardiography (c-TTE) with a modified Valsalva maneuver performed by blowing into a handmade pressure monitoring manometer device to reach and maintain a pressure of 40 mmHg for at least 5 seconds, using an injectable contrast agent (1 mL air, 8 mL saline, 1 mL patient blood).

C

Comparator

Traditional method of contrast transthoracic echocardiography (c-TTE) with the traditional Valsalva maneuver (expiration against a closed glottis/closed nose and mouth after a full inspiration), performed in the same patients in random order with an interval of at least 10 minutes (both compared against contrast transesophageal echocardiography [c-TEE] as the gold standard).

O

Outcome

Diagnostic sensitivity and specificity for patent foramen ovale right-to-left shunt (PFO-RLS) detection (defined as microbubbles appearing in the left atrium within three cardiac cycles after Valsalva release), using contrast transesophageal echocardiography (c-TEE) as the gold standard.surrogate

Main Result

Absolute Event Rate: 92.83% vs 83.87%

p-value: p=0.001

Using a simple handmade manometer device to maintain 40 mmHg strain during the Valsalva maneuver significantly improves the sensitivity of contrast transthoracic echocardiography for diagnosing patent foramen ovale.

Limitations

The order of randomization may have helped some patients perform an effective Valsalva without the device, introducing a potential practice effect.
The underlying physical mechanism for the higher sensitivity is still unclear.
Single-center preliminary study requiring further prospective multicenter studies with larger populations to confirm conclusions.
The order of randomization may have helped some patients perform an effective Valsalva without the device, creating a potential practice effect.
The underlying physical mechanism for this finding is still unclear.
Single-center study requiring further prospective multicenter studies with larger populations.

Implication

Supports manometer-guided Valsalva in contrast TTE for suspected PFO; extends diagnostic protocols with RCT evidence.

Abstract

Purpose . To compare the sensitivity and specificity of modified and traditional methods of contrast echocardiography of the right portion of the heart in patients with a suspicion of patent foramen ovale (PFO). Methods . The study population consisted of 506 patients with high clinical suspicion of PFO. The traditional Valsalva maneuver consists of expiration against a closed glottis after a full inspiration. A modified Valsalva maneuver was performed with a handmade pressure monitoring device, which measured pressure during performance of the Valsalva maneuver. Modified and traditional methods of contrast echocardiography were performed among all patients. Contrast transesophageal echocardiography (TEE) was regarded as the gold standard. Results. A total of 279 patients with PFO were confirmed by TEE. 259 cases (sensitivity: 92.83%) were detected by a modified method of contrast echocardiography of the right portion of the heart, while 234 cases were detected using the traditional method (sensitivity: 83.87%). The sensitivity of modified contrast echocardiography of the right portion of the heart was significantly higher than that of the traditional method (92.83% vs. 83.87%, P =0.001). However, there was no significant difference in the specificity of the two methods for the diagnosis of PFO (97.35% vs. 96.03%, P =0.431). Additionally, the results of semiquantitative evaluation of PFO using modified method failed to show a more positive rate than shown by the traditional method (Z=−1.782, P =0.075). Conclusions. Modified contrast echocardiography of the right portion of the heart yielded a higher sensitivity than the traditional method, which contributed to the diagnosis of cardiac PFO. The research was a part of a register study (https://register.clinicaltrials.gov/ ClinicalTrials ID: NCT02777359 ).

Discussion

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Cite This Study

Zhao et al. (2019) conducted an RCT in High clinical suspicion of patent foramen ovale (PFO) (n=506). Modified Valsalva maneuver with contrast transthoracic echocardiography (c-TTE) using a handmade pressure monitoring device vs. Traditional Valsalva maneuver (expiration against a closed glottis after a full inspiration) with contrast transthoracic echocardiography was evaluated on Diagnostic sensitivity for detecting patent foramen ovale right-to-left shunt (PFO-RLS) compared against contrast transesophageal echocardiography (c-TEE) gold standard (p=0.001). Modified contrast transthoracic echocardiography using a manometer-guided Valsalva maneuver significantly increased PFO diagnostic sensitivity compared to the traditional method (92.83% vs. 83.87%, P=0.001).

synapsesocial.com/papers/6a785578df493903fd1f8ecf https://doi.org/10.1155/2019/9828539

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Modified Method of Contrast Transthoracic Echocardiography for the Diagnosis of Patent Foramen Ovale

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Modified Method of Contrast Transthoracic Echocardiography for the Diagnosis of Patent Foramen Ovale

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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