Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation

Conditions

Prosthetic Valve Thrombosis

Brief summary

This is a prospective study designed to evaluate the structural and functional integrity of transcatheter or surgical bioprosthetic valves with multimodality imaging. The study further aims to confirm resolution of the early bioprosthetic valve thrombotic changes with anticoagulation.

Detailed description

Patients with a history of bioprosthetic valve replacement undergo cardiac contrast CT imaging and transthoracic echocardiography to evaluate structural and functional integrity of the aortic valves. The imaging studies will be performed at least 48-hours after bioprosthetic valve replacement. Patients with prosthetic valve abnormalities suggestive of thrombus will be administered anticoagulation therapy, followed by repeat contrast CT of the chest and transthoracic imaging. Repeat imaging following 3 months of anticoagulation therapy is performed to evaluate the response to anticoagulation therapy. I

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Impact of Balloon-Expandable TAVR Valve Deformation and Calcium Distribution on Outcomes in Bicuspid Aortic Valve.

Nagasaka T, Patel V, Shechter A, Suruga K, Koren O, Chakravarty T, Cheng W, Ishii H, Jilaihawi H, Nakamura M, Makkar RR.

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Commissural Alignment After Balloon-Expandable Transcatheter Aortic Valve Replacement Is Associated With Improved Hemodynamic Outcomes.

Raschpichler M, Flint N, Yoon SH, Kaewkes D, Patel C, Singh C, Patel V, Kashif M, Borger MA, Chakravarty T, Makkar R.

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2020-11-0191 citations

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Coronary Access After TAVR.

Ochiai T, Chakravarty T, Yoon SH, Kaewkes D, Flint N, Patel V, Mahani S, Tiwana R, Sekhon N, Nakamura M, Cheng W, Makkar R.

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Kazuno Y, Maeno Y, Kawamori H, Takahashi N, Abramowitz Y, Babak H, Kashif M, Chakravarty T, Nakamura M, Cheng W, Friedman J, Berman D, Makkar RR, Jilaihawi H.

2016-03-2139 citations

10.1093/ehjci/jew032

Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves.

Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Søndergaard L.

2015-10-05664 citations

10.1056/nejmoa1509233

Interventions

DRUGWarfarin

Patients with prosthetic valve abnormalities suggestive of thrombus will be administered anticoagulation therapy with Vitamin K antagonists (Warfarin) for 3 months with goal INR 2-3, followed by repeat contrast CT of the chest and transthoracic imaging. Repeat imaging following 3 months of anticoagulation therapy is performed to evaluate the response to anticoagulation therapy.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Presence of transcatheter or surgical bioprosthetic aortic valve implanted at least 48 hours prior to enrollment * Age 18 years or older * Ability to provide informed consent and follow-up with protocol procedures.

Exclusion criteria

* Renal insufficiency (creatinine \> 1.5 mg/dL) * Known allergy to iodinated contrast agents

Design outcomes

Primary

Measure	Time frame
Frequency of patients with structural/functional abnormalities of bioprosthetic valves	3 months

Countries

United States

Contacts

CONTACTTarun Chakravarty, MD

tarunchakravarty@gmail.com3104233977

PRINCIPAL_INVESTIGATORRaj Makkar, MD

Cedars-Sinai Medical Center, Los Angeles, California

Outcome results

None listed