Figure 1. Using a snare, the hydrophilic wire is guided from the left ventricle into the aorta.

Figure 2. The Amplatzer Vascular Plug III device is deployed over the paravalvular leak.

Figure 3. Angiography confirms the absence of mitral paravalvular leak.

Introduction

Paravalvular leak (PVL) is a well-known complication after surgical valve replacement, with an estimated incidence ranging from 2% to 10% depending on valve and prosthesis type. Its clinical presentation may vary from asymptomatic cases to severe heart failure, hemolytic anemia, and endocarditis. Management of PVL depends on regurgitation severity and presence of symptoms. Surgical reintervention has historically been the treatment of choice, but it carries significant risk, particularly in patients with multiple previous sternotomies. In this setting, percutaneous PVL closure has emerged as a minimally invasive alternative, with encouraging results in different clinical series.

In this article, we present the case of a patient with severe mitral PVL successfully treated by percutaneous closure with an Amplatzer Vascular Plug III device, highlighting the feasibility and safety of this strategy.

Clinical case

We present the clinical case of a 69-year-old woman with New York Heart Association (NYHA) functional class III/IV progressive dyspnea over the past 6 months. Relevant cardiovascular history included mechanical mitral valve replacement 12 months prior to symptom onset and remote mechanical aortic valve replacement. The patient’s chronic medication consisted of enalapril 5 mg/12 h, bisoprolol 2.5 mg/day, acenocoumarol 2 mg/day, and furosemide 40 mg/day. Physical examination revealed signs of heart failure such as bilateral lower-limb edema (3/6) and bibasilar crackles on lung auscultation. Cardiac auscultation revealed a holosystolic murmur at the mitral focus. Transthoracic (TTE) and transesophageal (TEE) Doppler echocardiography showed preserved left ventricular systolic function and severe PVL at the 10 o’clock position, with regularly functioning mitral and aortic prostheses. In view of these findings and the high perioperative risk due to two prior sternotomies, percutaneous anterograde PVL closure was indicated.

Technique

Under general anesthesia, the patient underwent transesophageal echocardiography that showed no visible thrombus in the left atrial appendage. After local anesthesia with 2% lidocaine, venous and arterial femoral access was obtained with 6-Fr introducers (Radiofocus, Terumo Corporation). Using the venous access, a multipurpose catheter was advanced through the brachiocephalic vein and, over a long Amplatz guidewire, exchanged for an 8-Fr Mullins sheath (Cook Medical). A Brockenbrough needle was advanced within the sheath to its distal end. From the braciocephalic vein, both sheath and needle were carefully advanced and positioned over the fossa ovalis. After confirming positioning by means of TEE, transeptal puncture was performed in the posterosuperior quadrant of the fossa ovalis. Once puncture was achieved, complications such as inadvertent aortic or pericardial entry were ruled out using echographic guidance (saline injection and bubble visualization) and hemodynamic pressure tracings (atrial waveform). The Mullins sheath was then advanced into the left atrium. A 6-Fr Judkins Right 4.0 catheter was inserted through the Mullins sheath and a long hydrophilic guidewire was advanced across the PVL into the left ventricle. A 5-Fr Judkins Right 4.0 catheter was advanced over a 0.035-inch Teflon wire via the arterial access, crossing the valve plane in right anterior oblique projection. Once in the left ventricle, a snare was used to capture the hydrophilic wire and redirect it into the aorta, creating an arterio-venous circuit (Figure 1). Finally, under simultaneous traction of the hydrophilic wire via the arterial access snare, an Amplatzer Vascular Plug III device (Abbott Cardiovascular, Santa Clara, CA, USA) was advanced to the PVL (Figure 2). After confirming correct positioning through multiple angiographic projections and TEE, the device was released—first the disc facing the left ventricle and then the disc facing the left atrium. Successful closure was confirmed with no residual leak on TEE and angiography (Figure 3). The patient was transferred to the Coronary Care Unit and discharged 48 hours after the procedure without complications. At the 6- and 12-month follow-up, the patient showed significant improvement in functional class, with no evidence of heart failure.

Discussion

Paravalvular leak (PVL) is a complication that can arise after valve replacement surgery and may lead to heart failure, hemolytic anemia, and endocarditis. Its prevalence varies according to the replaced valve and the type of prosthesis, but it is estimated to occur in approximately 2–10% of patients undergoing valve replacement1. PVL results from inadequate seal between the prosthetic valve and the surrounding cardiac tissue. This can be attributed to technical factors during surgery, such as improper prosthesis positioning or inadequate suturing, as well as to anatomical factors2. PVL diagnosis is usually established through transthoracic and transesophageal Doppler echocardiography, which allow for the assessment of regurgitation severity and its impact on cardiac function. Cardiac magnetic resonance imaging may also be useful in certain cases3. Defining PVL severity based on regurgitant fraction is essential: >30% corresponds to severe leak4. Management of PVL depends on regurgitation severity and presence of symptoms. Indications for PVL closure include symptomatic heart failure, significant hemolytic anemia due to paravalvular regurgitation, recurrent or persistent endocarditis involving the prosthetic valve area, and severe paravalvular regurgitation (>30% regurgitant fraction)5. In asymptomatic patients with mild to moderate PVL, regular clinical and echocardiographic surveillance may be appropriate. However, in symptomatic severe PVL, more aggressive treatment is required. In such cases, percutaneous closure emerges as the main strategy5. Percutaneous PVL closure is a minimally invasive technique that involves the deployment of occluder devices to seal the paravalvular defect. Three main percutaneous approaches are currently used: antegrade (from venous to arterial system, as in our case), retrograde (exclusively arterial, primarily used for aortic PVL), and transapical approach. In a case series published by Millán-Ruiz et al., the reported procedural success rate was 86% and the clinical success rate at 42-month follow-up was 89%. The 30-day percutaneous mortality rate was 4.6%, and freedom from cardiac-related death at 18 months reached 91.9%. Conversely, the in-hospital mortality rates for surgical reintervention were 13%, 15%, and 37% for the first, second, and third intervention, respectively, with a 10-year survival of only 30%6. Percutaneous PVL closure has therefore shown safety and efficacy in multiple series, with success rates varying according to anatomical complexity and operator experience7.

Conclusions

PVL is a significant complication after cardiac valve replacement and requires timely diagnosis and management. Percutaneous closure offers a viable and effective alternative for patients with symptomatic severe PVL and elevated surgical risk. Device and access route should be chosen within assessment by a multidisciplinary Heart Team. This case further supports the feasibility of the Amplatzer Vascular Plug III as a suitable option in the treatment of PVL.

1. García E, Sandoval J, Unzue L, Hernandez-Antolin R, Almería C, Macaya C. Paravalvular leaks: mechanisms, diagnosis and management. EuroIntervention. 2012;8:Q41-Q52. [Internet]. [citado 2023]; disponible en: https://eurointervention.pcronline.com/article/paravalvular-leaks-mechanisms-diagnosis-and-management.

2. Sorajja P, Cabalka AK, Hagler DJ, Rihal CS. Percutaneous repair of paravalvular prosthetic regurgitation: acute and 30-day outcomes in 115 patients. Circ Cardiovasc Interv. 2011;4(4):314-21. doi: 10.1161/CIRCINTERVENTIONS.111.962563.

3. García-Fernández MA, Pérez-David E, Quiles J, et al. Role of transesophageal echocardiography in the assessment of mitral regurgitation. Rev Esp Cardiol. 2004;57(10):962-9. doi: 10.1016/s0300-8932(04)77232-8.

4. Zoghbi WA, Enriquez-Sarano M, Foster E, et al. Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr. 2003;16(7):777-802. doi: 10.1016/s0894-7317(03)00335-3.

5. Gürsoy, Güner et al. Anatolian Journal of Cardiology. Paravalvular leak: diagnosis and treatment. Anatol J Cardiol [Internet]; disponible en: https://anatoljcardiol.com/article/AJC-10018/pdf.

6. Millán, X.; Skaf, S.; Joseph, L.; Ruiz, C. E., et al., “Reducción transcatéter de fugas paravalvulares: una revisión sistemática y meta-análisis”, Can J Cardiol. En impresión, doi: 10. 1016 / j. cjca. 2014. 

7. Gafoor S; Steinberg D; et al. EuroIntervention 2014;9:1359-1363. Tools and techniques clinical: paravalvular leak closure. EuroIntervention [Internet].;disponible en: https://eurointervention.pcronline.com/article/tools-and-techniques-clinical-paravalvular-leak-closure.

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