Transcatheter Closure or Surgery for Symptomatic Paravalvular Leaks: The Multicenter KISS Registry

Abstract

Background: The optimal treatment of symptomatic paravalvular leak (PVL) remains controversial between transcatheter closure (TC) and surgery. This large-scale study aimed to retrospectively evaluate the long-term outcomes of the patients who underwent reoperation or TC of PVLs.

Methods and results: A total of 335 (men, 209 [62.4%]; mean age, 58.15±12.77 years) patients who underwent treatment of PVL at 3 tertiary centers between January 2002 and December 2021 were included. Echocardiographic features, procedure details, and in-hospital or long-term outcomes were assessed. The primary end point was defined as the all-cause death during follow-up. The regression models were adjusted by applying the inverse probability weighted approach to reduce treatment selection bias. The initial management strategy was TC in 171 (51%) patients and surgery in 164 (49%) cases. Three hundred cases (89.6%) had mitral PVL, and 35 (10.4%) had aortic PVL. The mean left ventricular ejection fraction was 52.03±10.79%. Technical (78.9 versus 76.2%; P=0.549) and procedural success (73.7 versus 65.2%; P=0.093) were similar between both groups. In both univariate and multivariable logistic regression analysis, the in-hospital mortality rate in the overall population was significantly higher (15.9 versus 4.7%) in the surgery group compared with the TC group (unadjusted odds ratio, 3.13 [95% CI, 1.75-5.88]; P=0.001; and adjusted odds ratio (inverse probability-weighted), 4.55 [95% CI, 2.27-10.0]; P<0.001). However, the long-term mortality rate in the overall population did not differ between the surgery group and the TC group (unadjusted hazard ratio [HR], 0.86 [95% CI, 0.59-1.25]; P=0.435; and adjusted HR (inverse probability-weighted), 1.11 [95% CI, 0.67-1.81]; P=0.679).

Conclusions: The current data suggest that percutaneous closure of PVL was associated with lower early and comparable long-term mortality rates compared with surgery.

Keywords: death; echocardiography; paravalvular leak; surgery; transcatheter closure.

Figure 1. Flowchart for patient selection.

Figure 2. Mitral paravalvular leak as assessed by 2‐dimensional and 3‐dimensional transoesophageal echocardiography is quantitatively consistent with a severe paraprosthetic regurgitation (proximal isovelocity surface area radius: 11 mm, effective regurgitant orifice area: 50 mm², regurgitant volume: 80 mL).

The pressure gradient across the mitral valve reached 20 mm Hg (peak)/4 mm Hg (mean) (A). From a modified 104˚ approach, a paravalvular regurgitant jet can be seen by color flow imaging (yellow arrowheads) (B). Real‐time 3‐dimensional and 3‐dimensional color flow images of the prosthesis show the paraprosthetic defect (asterisk) and regurgitation (yellow arrowhead), which are localized at 11 o'clock according to clock‐face orientation (C, D). Determination of vena contracta width and area using multiplanar reconstruction of the 3‐dimensional color Doppler data set (E). In a modified 155˚ approach, the paravalvular defect size is determined to be 8.7×4 mm using 3‐dimensional color flow imaging (F). LAA indicates left atrial appendage; LA, left atrium; LV, left ventricle; and MVR, mitral valve replacement.

Figure 3. Temporal trend of technical success and in‐hospital mortality of paravalvular leak by percutaneous closure.

IH indicates in‐hospital.

Figure 4. Unadjusted survival curve using IPW‐Cox PH regression (A); adjusted survival curve using IPW‐Cox PH regression (B) between treatment groups in the overall population.

HR indicates hazard ratio; IPW, inverse probability‐weighted; PH, proportional hazard; and TC, transcatheter closure.

Figure 5. An overview of study design and clinical outcomes.

HR indicates hazard ratio; IPW, inverse probability‐weighted; PH, proportional hazard; PVL, paravalvular leak; and TC, transcatheter closure.

Figure 6. Schematic representation of the study outcomes.

PVL indicates paravalvular leak.