What does this research mean for the field?

Transcatheter paravalvular leak closure in intermediate- to high-risk patients achieves high procedural success, significantly improves symptoms of heart failure and hemolytic anemia, and demonstrates reasonable long-term survival. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

October 1, 2021Open Access

Long-term outcomes of catheter-based intervention for clinically significant paravalvular leak

Structured PICO

Does transcatheter paravalvular leak closure improve survival and symptoms in patients with clinically significant paravalvular leak?

Population

95 patients (undergoing 100 procedures) with clinically significant paravalvular leak (74 mitral, 26 aortic) following valve replacement surgery, deemed intermediate- to high-risk for repeat surgery. Mean age 62.6, 42.0% female, single-center (Israel). Presenting symptoms included heart failure (86%) and haemolytic anaemia (41%).

Intervention

Transcatheter (percutaneous) paravalvular leak (PVL) closure using various devices (predominantly AMPLATZER Vascular Plug III, AMPLATZER VP II, AMPLATZER Duct Occluder, Occlutech PLD, Nit-Occlud) via transseptal, retrograde, or transapical approach.

Outcome

Mortality at 90 days, 1 year, and 5 yearshard clinical

Transcatheter paravalvular leak closure demonstrates reasonable long-term survival and significant symptom improvement in intermediate- to high-risk patients, supporting its use as an alternative to repeat surgery.

Abstract

BACKGROUND: In most centres, clinically significant percutaneous paravalvular leak (PVL) closure following valve replacement surgery is reserved for those considered high-risk for surgery. There is a paucity of data regarding the long-term outcomes of these patients. AIMS: Our goals were to assess the long-term outcomes of patients undergoing percutaneous PVL closure. METHODS: A total of 100 consecutive transcatheter PVL closure procedures (74 mitral, 26 aortic) were performed in 95 patients between February 2005 and August 2019 at our hospital. Data collected included procedural success rates, indication-specific outcomes and mortality. RESULTS: Mean follow-up was 5.6±6.1 years, mean age 62.6±15.2 years, and 45.4% were female. The device was successfully implanted in 88 procedures (88.0%). Patients who presented with heart failure (n=57) had a significant improvement in NYHA classification (29.2% Class III/IV versus 100.0%, p<0.001). For patients who presented with haemolytic anaemia (n=38), haemoglobin increased (11.94±1.634 vs 9.72±1.49, p<0.001) and LDH levels were reduced (1,354.90±1,225.55 vs 2,039.40±1,347.20, p<0.001) following the procedure. Rates of mortality were 3.8% at 90 days, 15.6% after 1 year, and 27.2% after 5 years. CONCLUSIONS: For patients who are deemed intermediate- to high-risk for repeat surgery, transcatheter PVL closure shows reasonable clinical success rates, with a significant improvement in symptoms, and a relatively low rate of periprocedural complications.

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