Clinical Trial: Graded TTCE for Post-Embolization PAVM Monitoring

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Correlation of Graded Transthoracic Contrast Echocardiography With Chest CT Findings After Pulmonary Arteriovenous Malformation Embolization in Patients With Hereditary He

Brief Summary: Current HHT guidelines recommend CT scan to detect new or recurrent PAVMs after embolotherapy. Recent studies using transthoracic contrast echocardiography (TTCE) shunt grade for PAVM screening suggest that graded TTCE can accurately predict the size of PAVMs on chest CT and their amenability to embolization. This study's purpose is to evaluate whether TTCE shunt grade can also accurately predict PAVM size and amenability to treatment in patients who are post-embolization.

Detailed Summary: Embolization is the standard of care for pulmonary arteriovenous malformations (PAVMs) in the Hereditary Hemorrhagic Telangiectasia (HHT) population. PAVMs are abnormal connections between the veins and arteries and result in right-to-left shunting of blood within the lungs. Successful embolization results in PAVM resolution and decreases the complications associated with right-to-left shunting. Current guidelines recommend follow-up with interval chest CT scan to determine treatment success and detect new or recurrent PAVMs after embolization. This results in significant radiation exposure to the relatively young HHT population. An alternative to chest CT is graded transthoracic contrast echocardiography (TTCE), which measures the amount of right-to-left shunting within the lung and assigns a grade based on this amount. TTCE has the advantage of being radiation free compared to chest CT. To date, graded TTCE has only been studied as a screening tool for PAVMs. These studies have shown that graded TTCE is highly sensitive in detecting PAVMs and is comparable to chest CT when screening for PAVMs. Results indicate that TTCE grade can accurately predict PAVM size on chest CT and predict whether PAVMs are amenable to embolization. However, no studies have compared graded TTCE and chest CT in patients who are post-embolization and it is therefore unknown whether graded TTCE can be used in patients who have undergone PAVM embolization. The current study seeks to correlate post-embolization TTCE grade with chest CT findings to determine whether TTCE can accurately predict PAVM size and amenability to treatment in the post-embolization population.
Sponsor: University of Pennsylvania

Current Primary Outcome:

  • Differences between TTCE shunt grade and the number of PAVMs present on most recent chest CT scan. [ Time Frame: At the time of the echocardiogram (TTCE) ]
  • Differences between TTCE shunt grade and the size of PAVMs present on most recent [ Time Frame: At the time of the echocardiogram (TTCE) ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Correlation between TTCE shunt grade to presence of PAVMs amenable to embolotherapy (feeding artery >2 mm) on most recent chest CT [ Time Frame: 48 hours after echocardiogram (TTCE) ]

Original Secondary Outcome: Same as current

Information By: University of Pennsylvania

Dates:
Date Received: October 10, 2016
Date Started: October 2016
Date Completion: October 2018
Last Updated: October 17, 2016
Last Verified: October 2016