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Paravalvular leaks (PVLs) are complications of a surgical or percutaneous valve replacement. They are persistent defects between the native annulus and the sewing ring, which result in a regurgitant prosthesis. They are observed in 2–18% of patients after a surgical valve replacement (SVR) and in 7–40% after a transcatheter aortic valve replacement (TAVR). Clinical manifestations are heart failure and hemolysis. They develop in 1–5% of PVL patients, and they have a poor prognosis. Surgery was the only available treatment to improve the patient’s outcome. But it is a high-risk surgery in frail patients and PVL relapse is not rare. Percutaneous PVL closure has emerged as a promising technique. Nevertheless, it needs a careful assessment, demands high technical expertise, and still has limitations. This chapter focuses on the diagnosis of PVL after a SVR and transcatheter PVL closure (TPVL).
Faculty of Medicine of Tunis, Tunis El Manar University, Tunis, Tunisia
Rabta Hospital, Tunis, Tunisia
Abdeljelil Farhati
Rabta Hospital, Tunis, Tunisia
Mohamed Sami Mourali
Faculty of Medicine of Tunis, Tunis El Manar University, Tunis, Tunisia
Rabta Hospital, Tunis, Tunisia
*Address all correspondence to: fathia.zghal@fmt.utm.tn;, zghal.fathia@gmail.com
1. Introduction
Paravalvular leaks (PVLs) are complications of a surgical or percutaneous valve replacement. They are persistent defects between the native annulus and the sewing ring, which result in a regurgitant prosthesis. They are more frequent after a surgical replacement (SVR) of the mitral (SMVR) than the aortic valve (SAVR) (7–17% and 2–10%, respectively) [1, 2, 3]. They can be detected early or several decades after the index surgery [4]. PVL reemerged as a frequent and deleterious complication with transcatheter aortic valve replacement (TAVR) development. Where it was reported variably in 7–40% of patients, it decreased with prostheses and technical improvements. Only 1–5% of PVLs result in patent clinical effect [5]; hemolytic anemia or congestive heart failure. In patients with one or both clinical manifestations, spontaneous evolution is unfavorable, and an intervention is indicated. Percutaneous closure seems an optimal therapeutic solution, less invasive than surgery, and has promising results. Nevertheless, this technique demands high technical expertise, and it has its proper limitations and complications, hence indications should be carefully weighed.
PVL after SVR are several co-contributing factors, related to the anatomy of the valve, the surgical technique, the status of the patient, and/or to the surgeon’s experience [6], they are depicted in Table 1. In TAVR, massive and asymmetrical calcifications and elliptical annulus shape as the main anatomical contributors, insufficient sizing and insufficient depth implantation as procedural predictors and functional c.
Advanced age Endocarditis Low body mass index Denutrition Previous valvular interventions and paravalvular leak relapses
Lack of experience and low activity volume
Table 1.
Factors contributing to paravalvular leak occurrence after a surgical valve replacement.
Lass and low left ventricular ejection fraction (LVEF) as patient condition factors [7, 8], the experience of the operator remains important to consider. Infective endocarditis (IE) is a main cause of valve disinsertion and can also be a consequence of a mechanical disinsertion with a secondary bacterial infection [9, 10].
The three main clinical manifestations of PVLs consist of congestive heart failure (HF), anemia, and IE [9].
Congestive HF occurs in the case of large or multiple PVLs with a severe valve regurgitation.
While hemolytic anemia syndrome occurs in small PVLs. They are more frequent in mitral valves with preserved LVEF [10], which results in a high velocity and turbulent systolic regurgitant jet. Hemolysis and anemia may be permanent or intermittent. Hence, a partial improvement during follow-up should not exclude the diagnosis nor lead to investigation cessation.
Infective endocarditis syndrome may be secondary to a previous mechanical known or unknown disinsertion or the cause of the valve disinsertion. It is important to detect IE for specific treatment. TPVL is contraindicated in this case.
Clinical tolerance is not directly correlated to the size of the PVL [9], it is influenced by several factors, including the compliance of cardiac chambers compliance, ventricular functions, the existence and degree of anemia, and the rapidity of installation. Symptomatic patients are at the tip of the iceberg.
Subclinical PVLs are more frequent, they can remain stable and or lead to progressive heart function deterioration, or they can be unmasked by an intercurrent event like IE.
Subclinical PVLs were reported to affect the patient’s prognosis in SAVR and in TAVR [11, 12], they require a close follow-up and IE prevention. While symptomatic PVLs have a severe prognosis and an intervention, when feasible, is needed to improve their outcome [13].
We should have a high index of PVL’s suspicion when a patient presents with one of these figures even if first-line investigations, namely, transthoracic echocardiography (TTE) is negative. This is an essential step toward the diagnosis.
4. Cardiac imaging for paravalvular leak assessment and procedural guidance
Assessment of PVLs relay first on ultrasounds. Imaging modalities are complementary and multimodality imaging is usual.
4.1 Transthoracic Doppler echocardiography
TTE is performed as a first-line noninvasive test. It is essential for detection or suspicion of PVLs through direct or indirect signs. Indirect signs include chambers’ enlargement and pulmonary pressure elevation. Direct signs consist of visualization of the defect between the annulus and the prosthetic sewing ring, which should be distinguished from an artifact by simultaneous application of color Doppler and identification of the regurgitant jet. The whole circumference of the annulus should be examined carefully, the number, size, and extension of defects are noticed.
TTE can be sufficient, particularly, in anterior aortic PVLs to determine PVL characteristics, however, its sensitivity and precision are weak in mitral PVLs that can be totally missed by TTE due to acoustic shadows.
TTE is fundamental for the assessment of prosthetic valve flows, left and right ventricles and atria sizes and functions, pulmonary pressures, and other valves’ status [14, 15, 16].
TTE is usually the main test for periodic follow-up.
4.2 Transesophageal Doppler echocardiography
Two (2D) and Three (3D) dimensional TEE is the reference test for PVL assessment, it is performed after a comprehensive TTE, whether this latter was contributive or not.
TEE is essential for the investigation of mitral PVL, multiple PVLs, and complex ones [14, 15, 16] TEE permits to assess accurately the sites of the leaks by exploring the whole circumference of the sewing ring by 2D, 3D, and color Doppler modes. When using 3D imaging a careful gain setting and joint color Doppler imaging are important to eliminate gain dropouts [15].
A double opposite clock face is used to indicate the mitral and aortic PVLs sites. The mitral clock face is divided into septal, posterior, lateral, and anterior dials (Figure 1).
Figure 1.
Schematization of en face view by transesophageal three-dimensional echocardiography. 0, 50, 90, and 130° views: corresponding bidimensional transesophageal echocardiography plans, AV: Aortic valve, IAS: interatrial septum, LAA: left atrial appendage, LMS: left main stem, MV: mitral valve, RCA: right coronary artery, TV: tricuspid valve.
The number, shape, area, length, and height of PVLs are determined by 3D TEE [9, 14] which also indicates the defect distance from the ring and the PVL spatial position in relation to the mechanism of the prosthesis. Precise sizing using 3D multiplanar reconstruction is a key to choose an adequate device when a TPVL is indicated. Identification of calcifications and IE signs are important to discuss the feasibility and difficulty of a TPVL or surgical treatment (Table 2) [16, 17].
Pre intervention
Per TPVL guiding
Post intervention
Comprehensive cardiac assessment, including chamber sizes and functions, pulmonary pressure, all valves ‘morphologies, and flows Research for infective endocarditis Assessment of local anatomy of PVLs: location, shape, number, size/extension, rocking, local, calcifications Gradation of the severity of the regurgitation Gradation of suitability for TPVL, relying on previous anatomical Planification of procedures; choice of the approach, devices and occluders
Septal puncture Spatial catheters and guides orientation Occluder positioning Normal function of prosthetic valve Immediate results Residual leak Complications (tamponade)
Position (migration) Function of prosthetic valve Residual leak/relapse of regurgitation Complications (infective endocarditis…) General cardiac assessment, chambers’ size and function, pulmonary pressure.
Table 2.
Role of Doppler transthoracic and transesophageal echocardiography in paravalvular leak management.
The quantification of the regurgitation is better evaluated by non-orifice-related parameters. In fact, vena contracta and proximal isovelocity methods, are distorted by the irregular shape and location of the defect, they are rarely useful. The severity of the regurgitation is better appreciated by continuity equation, end-diastolic descending aorta velocity or reversal systolic pulmonary venous flow, cavities’ dilatation, and pulmonary pressures. The circumferential extension of the defect is also a useful parameter for the severity of the regurgitation as well as the feasibility of TPVL. These parameters are to consider in parallel with the clinical status of the patient.
2D and 3D TEE are essential for TPVL guidance, especially in mitral PVLs, while TTE and fluoroscopy can be sufficient to guide aortic PVLs closure. The utility of per procedure TEE is depicted in Table 2. Septal puncture is guided by biplane (45 and 130°) imaging when an anterograde approach is chosen for a mitral PVL reduction, real-time 3D and zoom mode are used to localize the guides and orient the crossing of the PVL then the right positioning of the occluder device. At crucial time of the procedure, the deploying, orientation, and position of the device are to be verified as well as the mobility of the prosthetic valve and its flow (Figure 2). Before the release of the occluder device, the residual leak is searched, qualified, and quantified. When significant, it leads to a change of the choice of the device or the indication of a complimentary ad hoc or differed procedure; residual leaks impact the prognosis (Figure 2) [16].
Figure 2.
Approaches for transcutaneous paravalvular leak closure.
Permanent per-procedural monitoring detects at any time of the intervention the occurrence of complications like pericardial effusion or tamponade, embolization of the occluder, impinging, and blocking of the valve.
TEE is important to consider during follow-up if a complication is suspected (i.e., endocarditis, relapse, or extension of PVLs).
4.3 Fluoroscopy
Fluoroscopy is useful to detect rocking prosthetic valves when there is an extensive disinsertion, or an abnormal movement is seen in TTE or TEE. Fluoroscopy is important for TPVL guiding [16].
Fusion imaging combines echocardiography and fluoroscopy, is precious to guide the TPVL, it saves intervention time and increase the success rate [17, 18].
4.4 Intracardiac echocardiography
Intracardiac echocardiography is also an innovative mean to guide TPVL. Unlike TEE it allows to get free from general anesthesia. A series of 21 interventions in 18 patients with intracardiac echocardiography help was reported without any complication related to the imaging technique itself and with an acceptable rate of procedural success [19].
4.5 Magnetic resonance imaging and cardiac tomography imaging
Magnetic resonance imaging and cardiac tomography imaging are useful in a multimodality imaging approach, which is crucial for aortic post-SAVR or post-TAVR PVLs. Cardiac tomography-fluoroscopy fusion imaging was used in experienced teams to achieve more reproducible results, higher success, and better short and long terms outcomes. Also, the extension of indications and treatment with the confidence of complex, multiple PVLs (especially aortic PVLs) were allowed [20, 21].
4.6 Angiography and video-densitometry
Video-densitometric angiography is an emerging method, it was used in prospective trials as a reference tool for post-TAVR PVL assessment. It was reported to have high accuracy and allowed an objective comparison between different TAVR prostheses [22, 23]. For Kitamura M et al. it is helpful in litigious cases and intermediate degrees of regurgitation [24].
Accurate assessment of PVLs remains challenging. American and Japanese imaging and interventional societies collaboration resulted in a key guideline article dedicated to the evaluation of valvular regurgitation after percutaneous valve repair or replacement to help the development and result assessment of these interventions [25].
Intervention is needed when the patient with PVL is symptomatic or has evolving subclinical consequences, such as left ventricular enlargement and function impairment, significant pulmonary pressure elevation at rest or with exercise, significant hemolysis, and infective endocarditis. In certain situations, the PVL-symptoms causality relationship has to be assessed in case of comorbidities. In other situations, symptoms have to be unmasked by effort tests. TPVL is currently considered in first-line when expertise is available. The first step is to eliminate contraindications to TPVL: evolutive sepsis, extensive disinsertion greater than the third of the circumference, and rocking valves. When these figures are present surgery is chosen. Otherwise, TPVL offers a less invasive solution in generally operated and frail patients.
After a full assessment, defining the objective of the procedure is primordial; in the case of heart failure presentation, every PVL reduction is beneficial. When the TPVL is motivated by hemolytic anemia it is important to achieve a total closure of the PVL.
TPVL planification includes the choice of an adequate approach and devices. The procedure is usually performed in a catheter laboratory under general anesthesia and joint TEE and fluoroscopy guidance. Antibiotic prophylaxis is applied by administration of a cephalosporine or vancomycin in case of penicillin anaphylaxis. Nonfractioned heparin is administrated to obtain an active cephalin time between 250 and 300 and prevent catheter thrombosis. These are generally long procedures; the use of fluoroscopy is optimized to 7.5 images/second and the use of a higher image frame rate (15 images/second) is restricted to necessary (device delivery).
Approaches: For the mitral valve, the anterograde transeptal approach is the most used, however, an anterograde transaortic approach is more suitable for septal and posterior PVLs. The combination of both approaches forming an arteriovenous loop and transapical access are alternatives particularly for large or multiple PVLs necessitating the use of multiple devices [21]. The retrograde approach is not feasible in the case of mechanical aortic valve (Figure 2).
For the aortic valve is concerned, the retrograde approach is the most used, and transapical approach, which is useful for multiple and complex PVLs [26].
Devices: Rare dedicated devices were designed by manufacturers; Amplatzer vascular plug III (Abbott Vascular) and the paravalvular leak device (Occlutech), they are theoretically more suitable than non-dedicated devices. Their characteristics are summarized in Table 3.
Table 3.
Characteristics of dedicated paravalvular leak devices.
Other non-dedicated devices were used for TPVL amplatzer vascular plug II and IV (Abbott Vascular), amplatzer duct occluder devices (Saint Jude Medical), atrial septal defect, and ventricular septal defect devices.
All devices are used off-label and do not have FDA approval [27].
The use of multiple devices can be necessary for large or multiple PVLs. This can be achieved one or more times [5].
Delivery sheaths: There is no dedicated delivery sheaths for PVL dedicated devices. Delivery sheaths for atrial septum, ventricular septum, or arterial duct devices adapted for PVL may have an insufficient length for aortic PVLs or nonoptimal diameters. Steerable sheaths facilitate the procedure and are imperative in mitral posteroseptal PVLs.
Figure 3 illustrates the main steps of a TEE-guided mitral TPVL.
Figure 3.
Illustration of steps of a complex mitral lateral and posterior paravalvular leak transcutaneous closure in a 52-years-old female with an aortic valve prosthesis and a Starr mitral valve prosthesis. A: Paravalvular leak in color Doppler transesophageal echocardiography. B: Assessment of the defect by three-dimensional transesophageal echocardiography. C: The septal tenting. prior to the septal crossing by the wire. D: crossing of the paravalvular leak by the delivery catheter. E: assessment of the occluder device deploying by fluoroscopy and echocardiography and verification of the prosthetic valve flow. F: final result assessment by fluoroscopy and three-dimensional echography after delivery of one lateral and two posterior devices (arrows).
6.1 Specific considerations for post-transcatheter aortic valve replacement paravalvular leaks
PVL after TAVR increases late mortality [28]. The assessment relies on a multimodality approach (ultrasounds, MSCT, hemodynamic, and angiography). The closure of TAVR-related PVLs can be considered during the TAVR procedure or subsequent follow-up. During the procedure, many techniques are available to reduce regurgitation. Oversized balloon post dilatation is effective to optimize the valve expansion and ensure a better seal but exposes to an over risk of cerebral embolic events. Snares are used when there is an inadequate depth of implantation. It is to consider with caution when there is heavy calcification as it can result also in their detachment and embolization. Valve-in-valve is used when the previous techniques are not feasible, especially when there is a nonoptimal first valve procedure. This technique can also be used later for surgical or transcatheter degenerated valves [29]. TAVR-related PVL can also be reduced by a TPVL as previously described.
Compared to surgery TPVL has lower technical success (about 90% vs. 70–86%) but less short-term adverse events and lower 30 days mortality (about 4 vs. 11%) [27, 30, 31, 32]. Mitral TPVL has higher adverse events and mortality rates than aortic TPVL [27]. Three years prognosis and survival are improved when the TPVL is successful without or with the only mild residual leak [33]. Indeed favorable result is obtained in case of the absence of significant residual regurgitation. After a first TPVL, repeated transcutaneous or surgical interventions can be needed during follow-up. The main adverse problems are worsening or new hemolysis in mitral PVLs, significant residual PVL, encroachment of the prosthetic valve, vascular injury, tamponade, hemothorax (transapical approach), device embolization, stroke, relapsing and new PVL, infective endocarditis, and death [3, 27].
Essential steps forward TPVL achievement begin with a clinical suspicion that should include heart failure, anemia, infection, and equivalent syndromes. TTE should be very large. Multimodality imaging assessment is encouraged and facilitates the localization, anatomy evaluation, and measurement of the PVLs, and it prepares and guides the closure intervention. Full patient assessment is also needed, including comorbidities, frailty. Indication should be led by a structural valve specialized heart team. The patient’s preferences are taken into account. The planification of intervention is precise and demands a large material set preparation to be able to adapt the technique and address complications, and can miss the diagnosis, particularly in the case of mitral PVL. The procedure is conducted in expertise centers. A long-term close follow-up is then needed as complications can occur at any time of the evolution.
Since its first description in 1992, TPVL has undergone an important evolution and become a confirmed technique. It is currently considered as a first-line and vital solution for PVLs reduction by many teams, even if surgery remains the reference technique in guidelines. It is important to note that it demands high expertise and is feasible only in Ref. centers with a multidisciplinary team contribution. It remains limited by dedicated devices availability and lack of financial support.
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Written By
Fathia Mghaieth Zghal, Abdeljelil Farhati and Mohamed Sami Mourali
Submitted: 19 May 2022Reviewed: 29 June 2022Published: 12 August 2022
Open access peer-reviewed chapter
