Catheter-based closure of paravalvular leak.

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Expert Review of Cardiovascular Therapy Downloaded from informahealthcare.com by Nanyang Technological University on 04/28/15 For personal use only.

Catheter-based closure of paravalvular leak Expert Rev. Cardiovasc. Ther. 12(6), 681–692 (2014)

Grant W Reed, E Murat Tuzcu, Samir R Kapadia and Amar Krishnaswamy* Department of Cardiovascular Medicine, Cleveland Clinic, 9500 Euclid Avenue, Desk J2-3, Cleveland, OH 44195, USA *Author for correspondence: Tel.: +1 216 626 2824 Fax: +1 216 445 6153 [email protected]

Paravalvular leak (PVL) is a serious complication from surgical and percutaneous valve replacement procedures. The most common manifestations include congestive heart failure and hemolytic anemia, which may cause considerable morbidity and mortality. Repeat surgery for PVL closure is often complicated and carries a reduced probability of success. As such, catheter-based techniques to eliminate PVL have been developed. Percutaneous PVL closure procedures rely heavily on multimodality imaging techniques such as echocardiography, fluoroscopy and computed tomography for diagnosis, technical planning and procedural guidance. Evidence demonstrates that catheter-based closure of PVL boasts high procedural success rates and favorable clinical outcomes. Given the rapidly advancing nature of this field, this review summarizes the contemporary diagnosis of PVL, common techniques used for percutaneous closure and the latest data on patient outcomes following this procedure. KEYWORDS: aortic valve • catheterization • mitral valve • paravalvular leak • paravalvular regurgitation

Paravalvular leak (PVL) is defined as regurgitant blood flow through a communication between native myocardial tissue and a procedurally implanted heart valve. PVL is an infrequent but serious complication of valve replacement procedures, as it greatly increases both morbidity and mortality [1,2]. Estimates are that PVL occurs in 1–5% of patients following aortic valve replacement (AVR), and in 2–12% of patients following mitral valve replacement [3–5]. Different studies suggest that some degree of PVL is common following most transcatheter AVR (TAVR) procedures [6–10], dependent to some degree on the type of valve placed. Up to 17% of patients have moderate-to-severe paravalvular aortic regurgitation (PAR) after TAVR using the first-generation balloon-expandable Edwards SAPIEN device, though newer iterations of this valve suggest lower rates [11]. Surgical repair of PVL is possible, but it is often technically challenging, and is associated with greater morbidity and mortality than a first-time operation, as is commonly observed with redo open-heart surgery [12]. Further, there is a high recurrence rate of PVL after surgery, sometimes necessitating multiple surgeries for a proper fix. As such, minimally invasive, catheter-based approaches to PVL closure have been developed [13]. Several series have demonstrated high procedural success rates and encouraging patient outcomes after informahealthcare.com

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percutaneous PVL closure [1,14–16]. Given the rapidly advancing nature of this field, this review will focus on the contemporary diagnosis and percutaneous treatments available for PVL, and discuss the latest evidence of patient outcomes following this innovative procedure. Clinical presentation

Patients with PVL may be asymptomatic, but typically present with symptomatic heart failure (85%) and hemolysis (13–47%) due to mechanical stress on red blood cells around the PVL [17]. Lab work may demonstrate a normocytic anemia, elevated lactate dehydrogenase and low haptoglobin level. Further, N-terminal pro-brain natriuretic peptide may be elevated, the degree of which may correlate with the severity of the PVL as well as 6-month mortality [18]. Most patients present within a few months to a year after valve replacement, but may present up to many years after the initial valve surgery [13]. Medical management of heart failure (i.e., afterload reduction, diuresis) and hemolytic anemia (i.e., periodic blood transfusions, erythropoietic agents) is typically utilized first, but when this fails to relieve symptoms, definitive correction of the PVL is needed. Risk factors

Surgical patients at the highest risk for PVL include those who have a mechanical valve

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Figure 1. Mitral valve anatomy as visualized from the left atrium. Clock-face nomenclature for localization of mitral and aortic paravalvular leak. LAA: Left atrial appendage. Reproduced with permission from [33].

placed, patients with infective endocarditis, patients with diffuse annular calcification and those who have had a previous valve surgery in the same site. All of these conditions may make it technically difficult to suture the new valve into the native heart tissue, and may predispose the patient to suture dehiscence in the recovery period [19]. Studies have shown that risk factors for PAR following TAVR include improper valve placement, undersizing of the valve, severe annular calcification and a large left ventricular outflow tract diameter [6,19]. Patient outcomes

Catheter-based PVL closure was first reported by Hourihan and colleagues in 1992 [14], and subsequently, a number of small case series demonstrated variable but reasonable success with the procedure [20]. Recently, two experienced groups have published encouraging evidence demonstrating that outcomes have improved as the procedure has evolved. The experience reported by Ruiz and colleagues demonstrated the outcome of 57 PVL closure procedures in 43 unique patients, most of whom had mitral PVLs (78%). The overall procedural success rate was 86%, and 30-day all-cause mortality was 5.4%, similar to surgical series that have demonstrated a mortality of 6% [15,17]. Overall, 10 patients required two procedures, and 2 required three procedures, reinforcing the fact that if the initial PVL closure is unsuccessful, reattempting the percutaneous approach is feasible and may provide success. Further, the paravalvular tissue may dehisce even after a successful closure procedure, requiring additional devices to be placed. A close inspection of pre-procedural imaging with an eye 682

toward valve stability is imperative in this situation; significant dehiscence should be approached surgically. Also encouraging is the fact that even though 35% of patients developed worsened hemolysis, the number requiring regular erythropoietic agents or blood transfusion decreased from 56 to 5%. A larger series by Sorajja and colleagues studied short-term outcomes for 141 PVL closure procedures in 115 unique patients, again mostly mitral PVLs (78%) [16]. Overall procedural success was 77% (80% for aortic PVL and 76% for mitral PVL), with a 30-day major adverse event rate of 8.7%. There were no procedural deaths, and only one patient required surgery for valve interference when the device could not be percutaneously retrieved, demonstrating the safety of the procedure. Post-procedure, only 10% of patients had moderate-to-severe or greater regurgitation. In the unsuccessful cases, residual regurgitation was cited as the most common reason. A second series by this same group studied long-term outcomes after 154 closure procedures in 126 unique patients [1]. The 3-year survival rate was 64%, and was unrelated to the degree of regurgitation, highlighting that patients who undergo PVL closure are often high-risk patients with other medical comorbidities. Further, the PVL closure appeared to dramatically improve the quality of life in the majority of patients. Although most patients had congestive heart failure prior to the procedure (93%), the majority of which were New York Heart Association class III or greater (69%), at 3-year follow-up 72% of patients had no or minimal dyspnea. Evidence of hemolysis was present in 37% of patients prior to PVL closure, and at 3 years persisted in approximately 50% of these patients, but appeared unrelated to the degree of residual regurgitation. The presence of hemolysis after PVL closure was found to be a negative prognostic factor. Given the evidence above, percutaneous PVL closure has emerged as a viable treatment option with demonstrated safety and efficacy. The efficacy of PVL closure for symptomatic heart failure is well established. However, the procedural success for treating hemolysis is less clear, as is the clinical significance of post-procedure hemolysis related to the device itself. Although patients with PVL often have many comorbidities, the considerable morbidity caused by the condition, the high-risk of repeat open-heart surgery and poor outcomes associated with surgical repair make percutaneous closure an attractive option for patients with PVL. PAR after TAVR

As previously mentioned, the incidence of PAR following TAVR is significant [21]. Data from the PARTNER IA trial of the Edwards SAPIEN valve in high-risk surgical patients showed that patients who underwent TAVR (n = 348) had a higher rate of PAR at 2 years than patients who had a surgical AVR (n = 351) (6.9 vs 0.9%, p < 0.001), even though overall survival was non-inferior [8]. In PARTNER I, moderate or severe PAR independently predicted mortality (hazard ratio: 2.11) [8]. Similarly, another study of a group of 667 patients who had TAVR with either the CoreValve or Edwards Expert Rev. Cardiovasc. Ther. 12(6), (2014)


Catheter-based closure of PVL

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SAPIEN valve found the incidence of A B PAR ‡2+ was 21%, and that moderateto-severe PAR was an independent predictor of mortality (hazard ratio: 3.8) [9]. Given the above situation, substantial attention has turned toward minimizing PAR after TAVR. Valve undersizing, malpositioning (i.e., too ventricular or aortic) or leaflet calcifications have all been shown to be causes of PAR. Further, accurate valve sizing is necessary to minimize other complications of oversizing (e.g., complete heart block, annular rupture) and undersizing (e.g., valve embolization). While surgical sizing of the aortic valve (AV) Figure 2. Mitral valve anatomy as viewed from the left ventricle. (A) Anatomical prosthesis allows for use of surgical dilators view of the mitral valve from the left ventricle. (B) Correlation of mitral valve anatomy prior to suturing the valve in place, annuwith transesophageal echocardiography. Numbers refer to the ‘clock-face’ nomenclature lar sizing for TAVR must occur nonsystem, labeled as viewed from the left atrium (described in FIGURE 1). LAA: Left atrial appendage. invasively, and as such is inherently less Reproduced with permission from [33]. accurate. Recently, there has been a realization that echocardiography is limited by its 2D imaging structure, and often underestimates the true post-dilation is still considered reasonable when necessary to annular size by 1–1.5 mm [22], which is important, as undersiz- reduce moderate or severe PAR. Persistent PAR may be ing by even 0.7 mm may result in moderate/severe PAR [23]. addressed by placing a 2nd valve within the 1st prosthesis (valveContemporary data suggest that 3D reconstruction with multide- in-valve), and if this is not possible or successful, a percutaneous tector computerized tomography (MDCT) provides a more PVL closure can be performed as described in this review. accurate sizing of the annulus, and may predict PAR [23]. A recent study compared prospectively sizing the prosthesis using Pre-procedural echocardiography MDCT or transesophageal echocardiogram (TEE), and found Overview that the MDCT group had significantly less PAR (7.5 vs 21.9%, The proper diagnosis and treatment of PVL is best accomp = 0.045) [23]. Thus, as the initial TAVR studies were done plished with the integration of several imaging modalities. In using echocardiographic sizing criteria, it is hopeful that the most patients, the initial diagnosis of PVL is made by transthouse of MDCT-guided annular sizing and valve selection may racic echocardiography (TTE), as it provides a non-invasive assessment of valvular anatomy and left ventricular function. reduce PAR. Advances in TAVR technology also hold promise to The American Society of Echocardiography defines PVL as reduce the rates of PAR. While the balloon-expandable Edwards SAPIEN A B C valve cannot be moved once in place, the self-expandable CoreValve can be snared and repositioned, and several of the valves not yet US FDA-approved boast the ability to be repositioned prior to final deployment. If the valve is positioned properly but PAR still exists, the valve may be post-dilated to provide better apposition between the valve and aortic annulus. Approximately 10% of patients require post-dilation, and if performed the operator should take care not to excesFigure 3. Localization of mitral paravalvular leak using transesophageal sively dilate the valve, as this may cause echocardiography. (A) The cartoon, (B) demonstrates the origin of the PVL at 0˚ annular trauma or may increase the risk of and (C) 45˚. The PVL is therefore localized to the area between 9 and 10 o’clock. heart block. While some investigators have This location is confirmed by the patient’s percutaneous PVL closure illustrated in FIGURE 9. demonstrated a significantly greater risk Ao: Aorta; AV: Aortic valve; LA: Left atrium; LAA: Left atrial appendage; LV: Left ventricle; of stroke with post-dilation, this is not PVL: Paravalvular leak. a consistent finding [24,25]. Therefore, informahealthcare.com

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Figure 4. 3D echocardiography for mitral paravalvular leak closure. (A) 3D TEE with color Doppler demonstrates wide anteromedial leak from 12 to 2 o’clock (arrow). (B) Guidance of the wire and device delivery catheter (arrow) to the paravalvular leak using 3D transesophageal echocardiography. (C) Two Amplatzer Vascular Plug II devices in place (arrow). AV: Aortic valve; MV: Mitral valve; TEE: Transesophageal echocardiography. Reproduced with permission from [34].

occupying 20% as severe. That said, PVLs are often quite eccentric, and create turbulent blood flow, leading to underestimation of the size of the color-flow jet and proximal isovolumic surface area on TTE. Thus, grading the severity and properly localizing PVLs can be difficult by TTE. As such, if mild PVL is noted by TTE, or if it is not noted but the clinical suspicion is high, a TEE should be pursued. Additionally, in the setting of a mechanical valve replacement, there may be shielding artifact from the prosthesis on TTE, which may make it impossible to truly characterize and grade the severity of PVL without TEE. In rare instances, it may be unclear by both TTE and TEE

whether the leak is valvular or paravalvular, in which case angiography and intracardiac echocardiography (ICE) may be utilized for better definition. Echocardiographic localization of mitral PVL

Typically, the mitral valve (MV) is described as a ‘face on a clock’, as viewed from the left atrium (LA) [26]. By convention, the 12 o’clock position is centered above the anterior MV leaflet (adjacent to the AV), and the PVL is localized by position on the clock (FIGURE 1) [26]. In a large surgical series, the most common locations for mitral PVL were anteromedial (between 10 and 11 o’clock) and posterolateral (between 5 and 6 o’clock) [13]. Analyses from series on PVL following percutaneous repairs found similar findB A ings, that 45% of surgical mitral PVL were between 10 and 2 o’clock, and 37% were between 6 and 10 o’clock [15]. Localization of PVL using TEE requires the operator to conceptualize viewing the valve from the left ventricle (LV) [27], which is also the MV position in typical left anterior oblique (LAO) Carm angulation. Practically, this view is essentially a ‘flip’ of the surgeon’s view (a mirror image), as shown in FIGURE 2. Rotation of the TEE probe will interrogate a different portion of the MV at each Figure 5. Transthoracic echocardiogram and correlation with fluoroscopy in a respective angle [27]. Further, movement patient with mitral paravalvular leak. (A) Parasternal short axis view in a patient of cranial or caudal, and flexion of the with mitral PVL demonstrates a leak at approximately 10 o’clock. (B) Fluoroscopy (left imaging crystal will cut the valve at varianterior oblique view) in the same patient following mitral PVL closure with a 6 mm Aplatzer septal occluder. ous planes parallel to the probe, as demAVR: Aortic valve replacement; MVR: Mitral valve replacement; PVL: Paravalvular leak. onstrated by the dotted lines in FIGURE 2. Reproduced with permission from [33]. FIGURE 3 shows an example of using TEE

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to localize mitral PVL. In this example, both the 0˚ and 45˚ views confirm the leak origin between 9 and 10 o’clock. The 3D TEE with color Doppler can be utilized to further define the PVL orifice, and may be useful in procedural guidance (discussed further below), as long as shadowing from the prosthetic valve or percutaneous devices does not impair image quality (FIGURE 4). When TTE is used for diagnosis of PVL, the parasternal short axis view at the level of the MV is preferred. In this view, the localization of the PVL is described in the similar manner as previously demonstrated (FIGURE 5). Color Doppler is applied to assist in visualization; however, due to shadowing from the mechanical prosthesis, TTE is often inadequate and TEE must be used instead.

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Echocardiographic localization of aortic PVL

Similar to mitral PVL, localizing aortic Figure 6. Use of intracardiac echocardiography. (A) Transthoracic echocardiography demonstrates severe tricuspid valve PVL (arrowhead). (B) ICE demonstrates the PVL can be accomplished with the familTV PVL with wire across (arrowhead). (C) Pointing the ICE probe at the leak (arrowhead) iar ‘face on a clock’ method. FIGURE 1 aids the operator in directing the wire to the PVL (arrow). (D) Two Amplatzer depicts the typical nomenclature, with Vascular Plug II devices in place and (E) Minimal residual PVL after device closure the 12 o’clock position adjacent to the (arrowhead). anterior leaflet of the MV (i.e., between LA: Left atrium; LV: Left ventricle; PVL: Paravalvular leak; RA: Right atrium; RV: Right ventricle; TTE: Transthoracic echocardiography. the non- and left-coronary cusps). An alternative nomenclature system depicts the PVL location in relation to the adjacent coronary cusp, of the ICE probe in the right atrium (RA) to the tricuspid which can also be helpful in assessing the risk of coronary valve leak allows excellent quality imaging (FIGURE 6). Our common practice is for the initial catheter and wire artery impingement with percutaneous device implantation. placement to be guided by ICE, fluoroscopy and computerized Studies have shown that most aortic PVLs are between 7 and tomography (CT)–fluoroscopy fusion (discussed below). Addi11 o’clock (46%), followed by the 11–3 o’clock position tionally, for mitral PVL, ICE (or TEE) is imperative for guid(36%) [15]. While long-axis TTE and TEE views are useful in ance of puncture of the interatrial septum (IAS), as it allows defining the anteroposterior relationship of the PVL, short-axis views are most helpful in defining the PVL location in relation for precise localization of the transseptal (TS) puncture for to the coronary cusps (FIGURE 5), which allows for easy translation appropriate access to the PVL origin [28]. Generally, the TEE probe is placed after crossing the PVL with a wire. However, to the fluoroscopic projection of the aortic root. in patients with a medial mitral PVL or a bioprosthetic valve that does not cause much shadowing, ICE alone may be adePercutaneous PVL closure quate for guidance of the entire PVL closure. Conversely, for Imaging mechanical valves, shadowing from the prosthesis may create TEE & ICE Echocardiography plays an essential role in the PVL closure too much artifact, and in lateral mitral PVL, the ICE probe is procedure, as it provides complementary information when too far away in the RA to provide adequate spatial resolution. Even in situations where ICE is used to guide initial wiring used in addition to fluoroscopy. Although TEE provides the best spatial resolution, most percutaneous PVL closures can be of the PVL, TEE is often utilized to evaluate procedural sucperformed with intravenous conscious sedation rather than gen- cess, need for additional device placement and assessment of eral anesthesia with intubation; therefore to minimize TEE complications (i.e., valve impingement by the device). probe-dwell time, ICE and fluoroscopic landmarks are used until TEE is absolutely necessary. We find ICE to also be Fluoroscopy & angiography extremely helpful for tricuspid valve leaks, both for procedural There are certain nuances that should be mentioned with guidance and assessing the results of closure, as the proximity regard to fluoroscopic imaging for PVL closure. Bioprosthetic informahealthcare.com

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Figure 7. Aortic paravalvular leak. (A) Aortic root angiogram in the LAO projection demonstrates normal cusp anatomy. (B) Transesophageal echocardiogram short-axis view (45˚) demonstrates paravalvular leak at the junction of right and non-coronary cusps in a patient with prior transcatheter aortic valve replacement. (C) Aortic root angiography in the same patient (LAO projection) and (D) Amplatzer Vascular Plug II deployed in the paravalvular leak. LAO: Left anterior oblique; L: Left coronary cusp; LMCA: Left main coronary artery; N: Non-coronary cusp; R: Right coronary cusp; RCA: Right coronary artery. Adapted with permission from [33].

or mechanical valve replacements may be used as a reference point for procedural guidance. Orthogonal fluoroscopic views in many planes are needed to assure wire placement and PVL closure. This is most efficiently done with a biplane system. However, if biplane is not available, the C-arm should be repositioned repetitively to obtain the proper views, especially after device deployment to assure that prosthetic valve leaflet motion is not hindered. For aortic PVL, a shallow LAO view is often adequate. For mitral PVL, the 30˚ right anterior oblique and LAO are most useful for device placement. Further, angiography may be used to define the location of aortic PVL (FIGURE 7).

dwell-time, information taken from a pre-procedural cardiac CT may be overlayed on the fluoroscopic views, a technology known as ‘fluoroscopy–CT fusion imaging’ [26,29]. The fluoroscopy–CT fusion process has been described in detail previously, and is shown in FIGURE 8 [26]. Briefly, the location of the PVL is identified on echocardiography, and a corresponding mark is made on the pre-procedural cardiac CT. C-arm fluoroscopy (Syngo DynaCT Cardiac, Siemens Helthcare, Forcheim, Germany) is then used to acquire a rotational CT-like image, which establishes the position of the patient on the table, and allows proper correlation and localization with the pre-procedural CT. This procedural CT-like image is then registered to the pre-procedural DynaCT (socalled ‘3D-3D’ fusion). Subsequently, the markings made on the pre-procedural CT are overlaid onto the real-time fluoroscopic image, which assists in precise wire and catheter manipulation to the position of interest. Common markings include location of the TS puncture (if indicated), location of prosthetic valves and trachea to assure proper image overlay. Technical details

The success of the PVL closure procedure depends as much on pre-procedure planning as the technical experience of the operator. Careful consideration should be given both to the choice of access site used to approach the PVL as well as the specific occlusion device employed.

Choice of access site approach

The access site used to approach the PVL should be chosen based on the location of the PVL, the ability to provide enough support necessary for delivery of the closure device, as well as any previous mechanical prostheses that may interfere with the procedure. The common approaches include TS puncture, direct access across the LV apex (or ‘transapical’ [TA]), and a retrograde approach via the femoral artery. TABLE 1 describes the typical use of each approach.

Fluoroscopy–CT fusion imaging

TS approach

Fluoroscopy provides 2D images of 3D structures, and as such the operator must mentally integrate the TTE, TEE and ICE images with real-time fluoroscopy for optimal wire and catheter manipulation during the procedure. This is often technically challenging. In order to reduce procedural duration and TEE

A TS approach is most commonly used for mitral PVL. For the TS approach, a femoral venous sheath is placed, and the catheter is advanced anterograde to the IAS, which is then punctured from the RA to the LA [30]. Lateral mitral PVL is best approached via a routine high IAS puncture, while medial

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mitral PVL requires a stick lower and B A C more posterior in the IAS. If TS puncture is not possible due to an extensively calcified IAS, or the TS approach is attempted but fails, the retrograde approach via the femoral artery or LV apex should be pursued. After the IAS is punctured, it is dilated, and an Agilis NxT steerable guide catheter (St. Jude Medical, Minneapolis, MN, USA) is Figure 8. ‘Fluoroscopy–CT fusion’ to guide mitral paravalvular leak closure. advanced into the LA. The Agilis is an (A) Markings are made on a pre-procedural CT scan in the areas of interest (LAO projec8.5-french (Fr) system, available in three tion). (B) CT markings are overlaid on real-time fluoroscopy (LAO projection). (C) The different distal curve sizes (small, medium markings facilitate crossing of the paravalvular leak with a SAG (RAO projection). and large), which can be adapted to the Ao: Aorta; CT: Computerized tomography; IVC: Inferior vena cava; LAO: Left anterior PVL location and LA size. The operator oblique; LPA: Left pulmonary artery; MVA: Mitral valve apparatus; RA: Right atrium; RAO: Right anterior oblique; SAG: Still-angled glidewire. can then telescope a 120-cm 4-Fr angled Reproduced with permission from [33]. Glide catheter (Terumo Medical, Shibuya, Tokyo, Japan) into the LA through the Agilis, which allows for a wider range of directions for wire approach, and follows a similar format as detailed above. manipulation across the PVL [28]. Aside from the Agilis, other However, the guide catheter chosen is usually one with a curved catheters can be used as a guide as well (i.e., JR4, sharp curvature (such as an IMA [internal mammary artery] Hockey Stick, etc.). Once in position, the PVL may be wired catheter), as this is most useful in directing wires from the with a 0.035-inch stiff-angled glidewire (Terumo Medical), or LV across the aortic PVL. When the TS approach is used a hydrophilic 0.014-inch coronary wire if the 0.035-inch wire for aortic PVL closure, it is preferred that devices be delivered retrograde after externalization of the wire, as this miniproves too bulky for the PVL. After the PVL is crossed, the wire is advanced into the mizes the potential to traumatize the MV apparatus. descending aorta. At that time, if additional wire support is Similarly, patients with a prosthetic mitral valve replacement needed, the wire can be snared and externalized via a femoral should not be considered for a TS approach to aortic PVL artery sheath. If the patient has a mechanical AVR, the wire closure. can be exchanged in the LV for a stiffer wire such as the Amplatz Super Stiff (St. Jude Medical) or Lunderquist (Cook Femoral artery approach Medical, Bloomington, IN, USA) wires via a 0.035-inch com- Given the ease of access to the valve, a retrograde approach via patible microcatheter. Once the wire has enough support, the a femoral artery sheath is preferred for closure of aortic PVL. guide catheter is removed, the IAS further dilated and an A stepwise approach for closure of aortic PVL via a femoral Amplatz TorqVue delivery sheath is advanced into the LA. approach is shown in FIGURE 10. A hydrophilic 0.035 wire (i.e., a Choice of TorqVue size is based upon the planned device. In still-angled glidewire) is advanced via a guide catheter, which some situations, a 6-Fr Multipurpose Guide or peripheral inter- allows for precise control within the aortic root (i.e., A Multivention sheath alone may suffice. The TS approach to mitral purpose or AL-1). After the PVL is crossed, the 0.035 wire PVL closure of the patient presented in FIGURE 3 is shown in is exchanged for a stiffer wire (i.e., Amplatz Super Stiff or Lunderquist) to provide added support via an angled glide FIGURE 9. In the case of a large mitral PVL, more than one closure device catheter. If additional support is still needed, the wire may be may be needed. As demonstrated in FIGURE 9, operators may elect to initially advance the Table 1. Overview of paravalvular leak location and access site delivery catheter into the LV and pass a approach typically used. second 0.035-inch wire into the LV, which Location Approach Details allows for two delivery sheaths to be placed Mitral PVL Lateral/Anterior TS Anterograde; high IAS puncture and two devices to be deployed simulta† neously. Another option is that a smaller Medial/Posterior TS Anterograde; low/posterior IAS puncture 0.014-inch coronary guide wire may be advanced into the LV via the first delivery ‡ ‡ Aortic PVL Femoral > TS > TA Retrograde sheath alongside the first device, keeping † TS preferred, converted to femoral or TA if failed. A mechanical AVR precludes femoral approach to access to the leak if necessary after the first mitral PVL. ‡ Femoral preferred, TS or TA if additional support needed. A mechanical MVR precludes TS approach to device is deployed. aortic PVL. Closure of aortic PVL via a TS approach AVR: Aortic valve replacement; IAS: Intra-atrial septum; MVR: Mitral valve replacement; PVL: Paravalvular leak; TA: Transapical; TS: Transseptal. is rare compared with the femoral artery informahealthcare.com

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Figure 9. Transseptal approach to mitral paravalvular leak closure using two devices. (A) Wire across the leak (arrow) via the Agilis guide catheter (arrowhead). (B) Wire is advanced to the ascending aorta (arrow) and the descending aorta (arrowhead) and then externalized via the femoral artery. (C) The Agilis is removed and a TorqVue delivery sheath is advanced across the PVL. (D) Choosing a large enough TorqVue allows the operator to leave 0.035-inch wire across the PVL, while the 1st device is placed (arrowhead). (E) The 2nd delivery sheath is advanced over the wire and across the PVL (arrow). (F) A 2nd device is then deployed. (G) RAO projection after both Amplatzer Vascular Plug II are detached (arrow) and (H) LAO projection demonstrates devices at the 9 o’clock position, corresponding to the TEE localization (FIGURE 3). LAO: Left anterior oblique; PVL: Paravalvular leak; RAO: Right anterior oblique; TTE: Transthoracic echocardiogram.

snared via a TS puncture or direct LV apical approach, though this is a rare necessity. The device delivery sheath is then advanced retrograde across the leak, and the device deployed in the PVL with care being taken to avoid impingement of the coronary ostia. As above, the TS approach is preferred for mitral PVL, but if necessary to perform closure via the femoral artery an acutely angled or reverse-curvature catheter is necessary to cross the leak from the LV. The retrograde wire is snared via a TS puncture, and externalized via the femoral vein for added support. The occlusion device is then delivered antegrade across the mitral PVL. Patients with a mechanical AVR are not candidates for closure of mitral PVL via a retrograde femoral approach, out of concern for wire entrapment in the mechanical AV. TA approach

Obtaining access via a LV apical puncture may be needed in patients for whom the TS or femoral approaches fail or are not feasible (most commonly for patients with a calcified IAS that cannot be punctured, mitral PVLs that cannot be crossed from the LA and those patients undergoing mitral PVL closure in whom snaring the TS wire retrograde from a femoral approach causes impingement on the MV) [31]. Further, in patients undergoing mitral PVL who have a mechanical AV, snaring 688

the PVL wire via a TA approach may be the only option to provide better wire support, as crossing a mechanical valve with a wire may result in wire entrapment. This applies to patients undergoing aortic PVL with a mechanical MV as well. For the TA approach, the LV apex is carefully accessed using a micropuncture needle under fluoroscopic guidance. To avoid hitting the left anterior descending artery, coronary angiography should first be performed and used for guidance. Once access is obtained, the approach to PVL crossing and closure is similar to the TS and femoral procedures already described. For the aortic position, after the PVL is crossed, the wire may be advanced to the descending aorta and snared from the femoral artery if additional support is needed. Likewise, for mitral PVL, the wire may be advanced into the LA after crossing the PVL, and snared via a second catheter introduced via TS puncture for additional support. To minimize complications and the need for surgical closure, sheath size at the LV apex should be minimized. The apical wire can be snared via a femoral approach (for aortic PVL), or a TS approach (for mitral PVL). Then, the apical wire can be externalized, and the device deployed via femoral artery/vein to minimize LV apical dilatation. If sheath diameter can be limited to 6-Fr or less for the TA approach, the sheath can be removed without any closure needed, as the Expert Rev. Cardiovasc. Ther. 12(6), (2014)



scarred pericardium usually provides adequate hemostasis. Serial echocardiography should be performed in the catheterization laboratory after sheath removal to monitor for apical leak if this approach is used. Some centers have also had success using arterial closure systems (i.e., Perclose ProGlide) and patent ductus arteriosus occluder devices to seal the TA access site [32].

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Choice of PVL closure device

At this time, there are no devices labeled specifically for PVL closure, and a number of vascular and septal occluder devices have been used off-label for this purpose (FIGURE 11). PVLs are heterogeneous in their sizes, and while most are crescent-shaped, they are morphologically diverse. As such, pre-procedural planning should consider which and how many devices might be needed, and the operator should be ready to adjust this plan during the procedure, as deployment of one device may change the morphology of the PVL and require use of a different device in substitution or addition. In anticipation of this, the PVL may be crossed with a second wire prior to device deployment to facilitate deploying a second device if it is needed for proper closure as demonstrated in FIGURE 9. Additionally, the operator should consider the proximity of the leak to surrounding structures (including coronary ostia and mechanical leaflets) when choosing the device. TABLE 2 summarizes the devices commonly used for

Figure 10. Femoral approach to aortic paravalvular leak closure. (A) A SAG wire is advanced across the PVL via a guide catheter (an AL-1 in this case). (B) The guide catheter is advanced across the PVL into the LV and the SAG is exchanged for a stiffer Lunderquist wire. (C) TorqVue delivery sheath is advanced into the LV and (D) the AVP II is deployed. AVP: Amplatzer Vascular Plug; LV: Left ventricle; PVL: Paravalvular leak; SAG: Stiff-angled glidewire. Reproduced with permission from [33].

PVL closure.

Valve interference

The anatomic location of the atrioventricular node is at the junction of the IAS and the interventricular septum, and as such sits close to the medial aspect of the AV and MV. Thus, complete heart block may occur when devices are deployed at this location. As such, a temporary pacemaker wire should be ready to be placed during the PVL closure procedure.

In certain positions (e.g., leaks far away from to the ‘insertion posts’ of mechanical leaflet tilting discs), devices may impinge on the movement of the leaflets, especially those that are large (i.e., ventricular septal defect or atrial septal defect occluders). Thus, the operator should observe valve prosthesis function under both fluoroscopy and echocardiography after the occluder device is deployed, but before the delivery system is detached, to allow for retraction of the device if needed.

Device embolization

Coronary ostia occlusion

Data show that device embolization is rare, complicating 1–5% of PVL closures [15,16]. In nearly all cases, the device can be snared and retrieved percutaneously. Use of a bioptome is another option for retrieval. Further, if the device appears to be permanently stuck within the LV without risk for mobilization, it may be appropriate to leave it in place and monitor it serially with echocardiography or CT.

Closure of aortic PVL requires careful consideration of the proximity of the coronary ostia to the leak. Pre-procedural planning should include noting the position of the leak in the aortic sinus. Additionally, CT can be used to more precisely quantify the distance from the leak to the coronary ostia. During the procedure, after the device is deployed but before detaching the delivery system, careful attention should be paid

Complications Complete heart block

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A

B

D

C

after removal of the TA sheath from the LV or in the setting of hemodynamic instability. Similarly, a hemothorax may result from LV apical puncture, and as such patients should have a postprocedure chest x-ray, once the TA procedure is completed. Conclusion

E

Following valve replacement surgery, PVL may cause symptomatic heart failure, hemolysis and substantially increase both short- and long-term mortality. As repeat surgery for PVL carries high surgical risk of morbidity and mortality, and results are often not durable, percutaneous PVL closure has become more comFigure 11. Common devices used for paravalvular leak closure. (A) Amplatzer mon, with encouraging results reported Vascular Plug I. (B) Amplatzer Vascular Plug II. (C) Amplatzer septal occluder. (D) Amplatzer in observational studies. The proper diagmuscular septal occluder and (E) Amplatzer muscular ventral septal defect occluder. Reproduced with permission from [33]. nosis of and procedural guidance of percutaneous PVL closure requires the to the hemodynamic tracings and LV wall motion on echocar- integration of multimodality imaging including TTE, TEE, diography. Further, contrast injection via the delivery sheath or ICE, fluoroscopy, CT and hybrid fluoroscopy–CT fusion a pigtail catheter in the aortic root can be used to opacify the imaging. Currently, there are no catheters or devices designed coronary arteries and assure the coronary ostia are not impacted specifically for PVL closure. To maximize procedural success, by the device. operators must carefully decide access approach, which and how many occluder devices should be placed and be ready to Pericardial effusion & hemothorax think quickly if adjustments are needed during the procedure. Pericardial effusion may be caused by a number of aspects of As TAVR becomes more common, improvements in device the PVL closure procedure, including manipulation of stiff design and percutaneous approaches are needed to reduce wires in the LA and LV, breaching the cardiac chambers during PAR. With improvements in technology, outcomes following TS puncture or access via the TA approach. Throughout the TAVR and percutaneous PVL closure will only continue procedure, the pericardium should be monitored, especially to improve. Table 2. Summary of devices used for percutaneous paravalvular leak closure. Device name†

Design

Fabric inner layer‡

Important notes

AVP I

Cylinder design Nitinol mesh with large holes

No

Not often used

AVP II

Cylinder design Nitinol mesh more tightly woven Discs on each side of the central cylinder promote epithelization and a better seal

No

Largest experience Smaller sheath sizes than septal occluder devices

AVP III

Rectangular design Available in smaller sizes

No

Not yet available in the USA

ASD occluder

More effective seal Very large size may impinge on valve

Yes

Large size usually precludes use (esp. with tilting-disc mechanical valves)

VSD occluder

More effective seal Circular design Very stiff

Yes

Promotes hemolysis more than other devices

PDA occluder

More effective seal Easily delivered

Yes

Few sizes available limits use

†

All devices listed are Amplatzer (St. Jude Medical, St. Paul, MN, USA). Presence of a fabric inner layer makes sealing more effective, and is generally considered a positive feature. ASD: Atrial septal defect; AVP: Amplatzer Vascular Plug; PDA: Patent ductus arteriosus; VSD: Ventricular septal defect. ‡

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Expert commentary

PVL is a serious, disabling condition for many individuals. Evidence suggests percutaneous PVL closure is associated with good procedural outcomes, and as such has emerged as a viable alternative to open heart surgery at specialized centers offering advanced structural cardiac intervention options to patients. Advances in multimodality imaging have revolutionized percutaneous PVL closure, and has positioned PVL closure on the frontier of technological progress in cardiovascular medicine. Five-year view

The field of percutaneous PVL closure holds a bright future. Over the next 5 years, it is expected that the evidence base supporting percutaneous PVL closure will continue to evolve,

Review

hopefully with robust comparisons to surgical outcomes in similar groups of patients. It is likely that catheters and devices made specifically for PVL closure will be developed. With further refinements in multimodality imaging and procedural techniques and devices, patient outcomes will only continue to improve. Financial & competing interest disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties. No writing assistance was utilized in the production of this manuscript.

Key issues • Best estimates are that paravalvular leak (PVL) complicates approximately 1–5% of surgical aortic valve replacements, 2–12% of surgical mitral valve replacement and is more frequent after current generation transcatheter aortic valve replacement procedures. • Symptoms of PVL include congestive heart failure and hemolysis, which are indications for intervention if medical management fails. • Major risk factors for PVL after surgical valve replacement include those who have a mechanical valve placed, infective endocarditis, diffuse annular calcification and previous valve surgery in the same site. • Multimodality imaging with transthoracic echocardiography, transesophageal echocardiography, intracardiac echocardiography, multidetector computerized tomography and fluoroscopy–computerized tomography fusion are important components in the proper diagnosis and treatment of PVL. • There are no catheters or devices created specifically for PVL closure, and as such the devices are used off-label for this procedure. • Techniques for percutaneous PVL closure include the transseptal, femoral and transapical approaches, with access site choice guided by the presence of other mechanical valves and need for additional wire support during the procedure. • The most common occluder device used for PVL closure is the Amplatzer Vascular Plug II; however, other devices are often used at the discretion of the operator. • Complications of percutaneous PVL closure include valve interference, heart block, device embolization, coronary ostia occlusion, pericardial effusion and hemothorax.

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