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Otto et al 2020 ACC/AHA Guideline for the Management of Valvular Heart Disease February 2, 2021 Circulation. 2021;143:e72–e227. DOI: 10.1161/CIR.0000000000000923 e154 CLINICAL STATEMENTS AND GUIDELINES Recommendation-Specific Supportive Text 1. Echocardiography is the primary imaging modality to assess the location and quantify the severity of prosthetic valve regurgitation, often requiring both TTE and TEE approaches.1,3 Although TTE provides superior assessment of transvalvular gradients, chamber sizes, and function, TEE is better suited to identify the cause and location of regurgitation and is essential for prosthetic mitral valve because of acoustic shadowing on TTE. Even with prosthetic aortic valves, acoustic shadowing may affect detection of a paravalvular leak by either TTE or TEE, with TTE being suboptimal to assess posterior paravalvular leak and TEE suboptimal to assess anterior defects.3 The Valve Academic Research Consortium (VARC) has suggested an approach for assessment of paravalvular leak severity and constructed a 5-class grading scheme.7 2. 3D echocardiography plays a significant role in determining the precise location and size of the paravalvular leak in patients undergoing intervention. For a successful transcatheter paravalvular leak closure, adequate paravalvular leak assessment includes 1) precise location of the defect(s), 2) precise dimensions, 3) orientation of the defect in relation to the sewing ring and prosthetic valve occluders or leaflets, and 4) location and orientation of the subvalvular structures. Real-time 3D TEE allows optimal visualization of the defects and direct guidance for catheter movement and positioning of the implanted device(s) during the transcatheter closure procedure.4,5 3D TEE also allows assessment of residual regurgitation after device placement. Limitations of 3D TEE include artifacts of ultrasound imaging (eg, dropout, acoustic shadowing, reverberation artifacts) and reduced temporal and spatial resolution.8 Transcatheter closure using intracardiac echocardiography guidance is possible and alleviates the need for conscious sedation or anesthesia but allows only 2D and color Doppler imaging.9 11.9.2 Medical Therapy Medical therapy for prosthetic valve regurgitation is appropriate in asymptomatic patients or when the cause of regurgitation is valve thrombosis (see Sections 11.6 and 11.8) or prosthetic valve endocarditis (see Section 12.3), although further intervention may ultimately be needed in many of these patients. Some patients tolerate asymptomatic prosthetic valve regurgitation for many years, similar to patients with native valve regurgitation. However, there may be patients who develop rapid progression of the severity of bioprosthetic valve regurgitation because of leaflet degeneration. In patients with hemolytic anemia attributable to paravalvular regurgitation, medical management with folic acid and iron supplementation or periodic transfusion may be possible when the anemia is not severe, with intervention reserved for patients with symptomatic intractable anemia (see Section 11.8.3). 11.9.3 Intervention Recommendations for Intervention Referenced studies that support the recommendations are summarized in Online Data Supplement 41. COR LOE Recommendations 1 B-NR 1. In patients with intractable hemolysis or HF attributable to prosthetic transvalvular or paravalvular leak, surgery is recommended unless surgical risk is high or prohibitive.1–4 2a B-NR 2. In asymptomatic patients with severe prosthetic regurgitation and low operative risk, surgery is reasonable.1–4 2a B-NR 3. In patients with prosthetic paravalvular regurgitation with the following: 1) either intractable hemolysis or NYHA class III or IV symptoms and 2) who are at high or prohibitive surgical risk and 3) have anatomic features suitable for catheter-based therapy, percutaneous repair of paravalvular leak is reasonable when performed at a Comprehensive Valve Center.5–9 2a B-NR 4. For patients with severe HF symptoms caused by bioprosthetic valve regurgitation who are at high to prohibitive surgical risk, a transcatheter ViV procedure is reasonable when performed at a Comprehensive Valve Center.10–12 Synopsis Prosthetic valve degeneration can result in regurgitation attributable to leaflet calcification and noncoaptation or leaflet degeneration with a tear or perforation. Acute or chronic severe regurgitation may result in HF symptoms and signs. Paravalvular leak may result in hemolysis with symptoms attributable to anemia and HF. New paravalvular leak late after valve implantation raises the concern for IE, which should be excluded because the presence of infection would require antibiotic treatment before surgical therapy and would be a contraindication to transcatheter therapy. Symptomatic patients with paravalvular leak around a prosthetic valve are best managed by surgery, with percutaneous closure of the leak if the patient is at high or prohibitive surgical risk. Symptomatic patients with bioprosthetic valve regurgitation are best managed by surgery, with a transcatheter ViV procedure if the patient is at high or prohibitive risk. Because of rapid progression of bioprosthetic regurgitation, replacement of a leaking bioprosthesis may be considered even in the asymptomatic patient. Recommendation-Specific Supportive Text 1. Surgery is a viable therapeutic option in many patients with symptomatic paravalvular leak and is associated with reasonable outcomes.1 The risks associated with surgical intervention depend on the procedure required, be it suture repair or Downloaded from http://ahajournals.org by on October 7, 2026