Microvascular Plug (MVP) for the Treatment of Pulmonary ArterioVenous Malformations (PAVMs)

Microvascular Plug (MVP) for the Treatment of Pulmonary ArterioVenous Malformations (PAVMs)

Sponsors

Lead Sponsor: Johns Hopkins University

Source Johns Hopkins University
Brief Summary

The purpose of this study is to compare the use of the Micro Vascular Plug (MVP) system and other embolic devices in treatment of PAVMs. Pulmonary Arteriovenous Malformations (PAVMs) are abnormal connections between the pulmonary vein and the pulmonary artery. This affects blood flow between the heart and lungs which puts patients at risk of stroke, brain abscess, hypoxia and even sudden death. The standard treatment of PAVMs is embolization. Embolization is the placing of an embolic (synthetic agent) into a blood vessel to block blood flow. The embolic is inserted via a catheter into the blood vessel. Detachable coils are the most commonly used embolic in the treatment of PAVMs. Despite long procedure times, numerous coils that are often required to occlude a single PAVM and recanalization rates ranging from 5% to 15%, the most widely used embolic device is still the detachable coil.

Detailed Description

Transcatheter embolization has become the standard of care in the treatment of Pulmonary Arteriovenous Malformations (PAVMs). PAVM embolization is performed to prevent right to left shunting which puts patients at risk of stroke, brain abscess, hypoxia and even sudden death. Despite long procedure times, numerous coils that are often required to occlude a single PAVM and recanalization rates ranging from 5% to 15%, the most widely used embolic device is still the detachable coil delivered through a microcatheter. An alternative to coil embolization is the Amplatzer Vascular plug (AVP). AVPs allow for quick delivery of a single occluding device. AVPs, however, cannot be delivered through a microcatheter, limiting the AVPs' utility to larger PAVM with larger feeding arteries. The new MVPTM Micro Vascular Plug System (MVP, Medtronic) was designed to combine the best of both devices and allows for the occlusion of small vessels in a quick and predictable manner with a single embolic device through a micro catheter. At the investigators' institution the investigators have a very large PAVM practice, as the investigators are a large Hereditary Hemorrhagic Telangiectasia (HHT) center of excellence. Currently there is a paucity of data comparing these devices for the treatment of PAVMs. Specifically, there is little data to inform interventional radiologists' decision making process about which device to choose based on the patient's clinical characteristics, the size of the PAVM feeding artery, and cost. The investigators will create a registry/database of all patients who undergo embolization for Pulmonary AVM at the investigators' HHT center of excellence collecting data and adding in data from the investigators' existing PAVM database dating back at least the last 7 years. Patients with MVP embolizations will be assessed and compared to patients who are embolized with other solid embolic devices (coils/plugs). The investigators will assess reperfusion rates, immediate technical success, procedural attributes including procedure time, fluoroscopy time, contrast administration, and finally embolic and overall procedural costs.

Overall Status Recruiting
Start Date 2018-09-01
Completion Date 2022-01-01
Primary Completion Date 2022-01-01
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Reperfusion Rates Up to 3 Years
Immediate post-procedural success Immediately after procedure up to 5 minutes
Secondary Outcome
Measure Time Frame
Procedure duration Up to 4 hours
Fluoroscopy time Up to 4 hours
Contrast dose Up to 4 hours
Cost of embolic device per PAVM Up to 4 hours
Overall procedure cost for PAVM Up to 1 week
Radiation Dose Area Product (DAP) Up to 4 hours
Cumulative Air Kerma (AK) dose Up to 4 hours
Enrollment 200
Condition
Intervention

Intervention Type: Device

Intervention Name: Microvascular Plug (MVP)

Description: Patient's Pulmonary AVM(s) treated via transcatheter embolization with Microvascular Plugs.

Arm Group Label: Patients treated for Pulmonary Arteriovenous Malformation

Intervention Type: Device

Intervention Name: Amplatzer Vascular Plug (AVP)

Description: Patient's Pulmonary AVM(s) treated via transcatheter embolization with Amplatzer Vascular Plugs.

Arm Group Label: Patients treated for Pulmonary Arteriovenous Malformation

Intervention Type: Device

Intervention Name: Detachable coils

Description: Patient's Pulmonary AVM(s) treated via transcatheter embolization with detachable coils.

Arm Group Label: Patients treated for Pulmonary Arteriovenous Malformation

Eligibility

Sampling Method:

Probability Sample

Criteria:

Inclusion Criteria: - Undergoing embolization of Pulmonary Arteriovenous Malformation (PAVM) Exclusion Criteria: - PAVM unable to be embolized

Gender:

All

Minimum Age:

N/A

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Clifford R Weiss, M.D. Principal Investigator Johns Hopkins University
Overall Contact

Last Name: Clifford R Weiss, M.D.

Phone: 410-614-0601

Email: [email protected]

Location
Facility: Status: Johns Hopkins University
Location Countries

United States

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Patients treated for Pulmonary Arteriovenous Malformation

Description: All participants in the study will be patients who have been treated for Pulmonary Arteriovenous Malformation using Microvascular Plugs, Amplatzer Vascular Plugs or Detachable coils.

Study Design Info

Observational Model: Cohort

Time Perspective: Other

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