Mitral paravalvular leak closure: Transcatheter and surgical solutions

CARREV-01629; No of Pages 10 Cardiovascular Revascularization Medicine xxx (xxxx) xxx

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Cardiovascular Revascularization Medicine

Mitral paravalvular leak closure: Transcatheter and surgical solutions Sercan Okutucu a,⁎, Markus Mach b,c, Ali Oto a a b c

Department of Cardiology, Memorial Ankara Hospital, Ankara, Turkey Division of Cardiac Surgery, Medical University Graz, Austria Heart Team Austria and Karl Landsteiner Institute for Cardiovascular Research, Austria

a r t i c l e

i n f o

Article history: Received 16 April 2019 Received in revised form 17 June 2019 Accepted 25 June 2019 Available online xxxx Keywords: Closure Intervention Paravalvular leak Percutaneous Mitral valve Surgery

a b s t r a c t Paravalvular leak (PVL) is an important complication after surgical valve replacement and might lead to serious clinical results, including heart failure and/or hemolytic anemia. PVLs are the result of an incomplete seal between the sewing ring and annulus. It frequently affects surgical valves in the mitral position, occurring in 5% to 15% of valve replacements. For years, surgery has been considered the only treatment for symptomatic patients with PVLs. However, surgical re-intervention for PVLs is associated with a high risk of morbidity and mortality. Therefore, percutaneous treatment of PVL has become first-line therapy for most patients with symptomatic PVL. In this review, we will briefly summarize clinical findings, diagnostic modalities, laboratory assessment, surgical treatment, transcatheter approaches, device choice and outcomes of interventions in mitral PVLs. © 2019 Elsevier Inc. All rights reserved.

Contents 1. 2.

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1. Search strategy, and data collection . . . . . . . . . . . . 3. Diagnosis of PVLs . . . . . . . . . . . . . . . . . . . . . . . . 3.1. Clinical findings . . . . . . . . . . . . . . . . . . . . . 3.2. Echocardiographic evaluation of PVLs . . . . . . . . . . . 3.3. Other imaging modalities . . . . . . . . . . . . . . . . . 3.4. Laboratory assessment . . . . . . . . . . . . . . . . . . 3.5. Treatment algorithms . . . . . . . . . . . . . . . . . . 4. Surgical treatment for mitral PVLs . . . . . . . . . . . . . . . . 4.1. Surgical techniques for mitral PVL closure . . . . . . . . . 4.2. Outcomes for surgical mitral PVL closure . . . . . . . . . . 4.3. Outcomes of surgical versus percutaneous mitral PVL closure. 5. Transcatheter techniques . . . . . . . . . . . . . . . . . . . . 6. Device choice . . . . . . . . . . . . . . . . . . . . . . . . . 7. Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . 8. Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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1. Introduction ⁎ Corresponding author at: Memorial Ankara Hospital, Department of Cardiology, Cankaya/Ankara P.O: 06520, Turkey. E-mail address: [email protected] (S. Okutucu).

Paravalvular leak (PVL) is defined as regurgitant blood flow through a gap between surrounding myocardium and a prosthetic heart valve. PVL is a rare but serious complication of valve replacements, as it

https://doi.org/10.1016/j.carrev.2019.06.012 1553-8389/© 2019 Elsevier Inc. All rights reserved.

Please cite this article as: S. Okutucu, M. Mach and A. Oto, Mitral paravalvular leak closure: Transcatheter and surgical solutions, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.06.012

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increases both morbidity and mortality [1,2]. PVLs frequently affects surgical valves in the mitral position, occurring in 5% to 15% of cases [3]. Mitral PVLs is typically associated with dehiscence of sutures and may result from infection, annular calcification, friable annular tissue, or technical factors at the time of implantation [4,5]. For many years, surgery has been the available therapy for the treatment of clinically significant mitral PVLs. However, surgical reintervention is associated with mortality rates around 15% with a high rate of PVL recurrence [6,7]. Transcatheter PVL closure has emerged as an alternative to surgical reoperation with first reported case in 2003 using a ductal coil [8]. Since then, various devices have been used with varying degrees of success [6,9–14]. Herein, we performed a literature search and reviewed the diagnostic methods, available devices, surgical techniques, transcatheter approaches and outcomes for closure of mitral PVLs. 2. Methods 2.1. Search strategy, and data collection We performed a search of the PubMed database, Scopus, and the Web of Science, using key words, Mitral [All Fields] AND (paravalvular [All Fields] AND leak [All Fields]) AND closure [All Fields]” (last update: 21 March 2019). There was no date or language restriction for our selection of publication. References of selected studies and all abstracts from cardiology congresses (American College of Cardiology, American Heart Association, European Society of Cardiology, Transcatheter Cardiovascular Therapeutics) were searched for relevant data. 3. Diagnosis of PVLs 3.1. Clinical findings Although most PVLs are small, remain asymptomatic, and have a benign clinical course, larger PVLs ends up with serious clinical results such as heart failure (HF) (around 90% of cases) and/or hemolysis (one third of cases) [15,16]. The symptoms are dyspnea, and fatigue secondary to HF and hemolytic anemia [15–17]. Clinically significant PVLs most often occur in association with mitral prostheses [16]. Furthermore, PVL, like any intracardiac defect creating a significant turbulent flow, is an important pre-existing condition in the context of bacteremia to develop infective endocarditis [11,18]. Cardiac murmurs when noticed in a patient with prosthetic valve, increases concern about PVLs. In mitral PVLs, the most prominent finding is a holosystolic murmur heard over the left sternal border, with radiation dependent on the trajectory of the regurgitant jet [19]. However, auscultation lacks the specificity for diagnosis. Imaging modalities should be performed to confirm or rule out the presence of PVLs [19,20].

3.2. Echocardiographic evaluation of PVLs The evaluation of PVLs is similar to that used for native valvular regurgitation. However, it is more challenging and limited by artefacts of the prosthetic valve. This is particularly difficult during transthoracic echocardiographic evaluation of mechanical mitral prostheses. With transesophageal echocardiography (TEE), the left atrium becomes the near-field chamber and mitral regurgitation can be more readily evaluated [17,20,21]. In order to enable communication between the echocardiographer and the interventionalist, the location of the dehiscence is best defined in relation to internal landmarks such as the left atrial appendage and aortic valve. A clock face is often used to describe PVLs [17] (Fig. 1). In the assessment of mitral PVLs, the area of dehiscence can be detected by TEE as an area of echo drop-out outside the sewing ring and presence of the PVL on color-flow imaging. Color-flow imaging is used to localize the PVLs as well as to assess the severity (Fig. 2). The whole sewing ring should be examined carefully by sweeping the mitral prosthesis from 0° to 180°. Real-time 3D TEE imaging is important for the localization and quantification of PVLs. It provides accurate determination of the number and location of areas of paravalvular dehiscence [17,20–22]. Commonly used parameters of mitral regurgitation severity in this setting are jet width and jet area. Although the proximal isovelocity surface area (PISA) approach has not been validated in the setting of PVL, the presence of a large PISA shell is consistent with more severe regurgitation. Pulsed Doppler assessment of the pulmonary vein pattern might be useful, and the detection of systolic retrograde flow is a specific sign of severe mitral regurgitation [17,20,21]. Echocardiographic key criteria for evaluation of mitral prosthetic PVLs are summarized in Fig. 3. TEE, especially real-time 3D imaging, is the most useful method for guiding of the procedure. It is important to avoid misdiagnosing areas of echo drop-out as PVLs. If the dehiscence is large (N25% of the circumference), a single device is unlikely to be sufficient. Additionally, when the PVL size is N25% of the circumference, the prosthesis may rock, and it may be unwise to proceed with device closure because of the high risk of device embolization. Since oral anticoagulation may have been withheld in these patients, thrombus formation on the prosthetic valve or within the cardiac chambers and left atrial appendage should be excluded [17,21]. When the antegrade approach is used, TEE may be used to guide the transseptal puncture and help minimize the risk of inadvertent puncture of surrounding structures. Higher puncture allows better access to the lateral mitral annulus. Low-posterior puncture helps accessing medial parts of mitral valve. TEE also can help guide the passage of the guidewire and catheter through the PVL. Real-time 3D TEE has been shown to be particularly helpful for passage through PVLs. TEE helps proper deployment of the PVL closure device. Function of the prosthetic valve should be assessed to ensure that the PVL occluder does not

Fig. 1. Surgical view of mitral PVLs and clock-face orientation (A), 4-D view of mechanical mitral valve (B).

Please cite this article as: S. Okutucu, M. Mach and A. Oto, Mitral paravalvular leak closure: Transcatheter and surgical solutions, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.06.012

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Fig. 2. Real-time rendering 4-D echocardiography (A) and color-flow imaging reveal PVL in mechanical mitral valve (shown with arrows). Please note that PVL is localized between 9 and 10 o'clock according to clock-face orientation.

impede proper opening and closing of the prosthetic leaflets/discs. With mechanical prosthetic valves, fluoroscopy should also be used to assess the motion of the leaflets. After release of the device, TEE is performed to assess residual PVLs. If the residual PVL is severe, placement of additional devices might be considered [17,21]. Intracardiac echocardiography (ICE) is a unique imaging modality which provides high-resolution real-time imaging without the requirement for general anesthesia or esophageal intubation with shorter procedure and fluoroscopic times. Percutaneous PVL closure guided by ICE is feasible and safe imaging modality which and associated with acceptable procedural success rates [23]. 3.3. Other imaging modalities Cardiac fluoroscopy is useful to monitor and control delivery tools during transcatheter closure of PVLs. Two of most commonly used projections; right anterior oblique projection shows the sewing ring tangentially and the left anterior oblique view shows the valve en-face (Fig. 4). The main disadvantages of fluoroscopy are the inability to determine the 3-D anatomy of intracardiac tissues and exposure to radiation. Fusion of fluoroscopy and real-time 3-D TEE is a useful method in catheter-based PVL closure [24,25]. Angiographic visualization is useful for diagnosis, definition of the localization and estimation of the size of

PVLs. In case of mitral PVLs, the utility of angiography is less well established; however, anterolateral PVLs are best approached with fluoroscopy in the posteroanterior view with cranial angulation, posteroseptal PVLs in the right anterior view, and lateral PVLs in the lateral view [26]. Reconstruction with volume rendering of pre-acquired computerized tomography (CT) angiographic images allows identification of PVLs on the reconstructed image and helps to identify the best projection to cross the wire [16,27]. It is also very useful to identify the apex and to define the course of the left anterior descending artery in cases of transapical approach. Magnetic resonance imaging estimates the flow-imaging and volume-based measurements showing high-grade PVLs. It can accurately assess periprosthetic valve leakage with multiple regurgitation jets [16]. 3.4. Laboratory assessment The turbulent flow caused by the leak around the prosthetic valve is presumed to generate excessive shearing forces on red blood cells, resulting in intravascular mechanical hemolysis (24). The hemolysis work-up should also include serum lactate dehydrogenase, haptoglobin, iron and folic acid levels and peripheral blood smear examination for schistocytes [28].

Fig. 3. Echocardiographic key criteria for evaluation of mitral prosthetic PVLs. CMR, cardiac magnetic resonance imaging; CT, computerized tomography; EROA, effective regurgitant orifice area; LV, left ventricle; LVOT, left ventricular outflow tract; MVR, mitral valve replacement; PHT, pressure half time; PVL, paravalvular leak; RF, regurgitant fraction; RVol, regurgitant volume.

Please cite this article as: S. Okutucu, M. Mach and A. Oto, Mitral paravalvular leak closure: Transcatheter and surgical solutions, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.06.012

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Fig. 4. Fluoroscopic projections for mitral PVL closure. Right anterior oblique projection (A) shows the sewing ring on its side and the left anterior oblique view (B) shows the valve en-face.

3.5. Treatment algorithms

4. Surgical treatment for mitral PVLs

The indication for reoperation or interventional PVL closure should be made after thorough risk-benefit evaluation within the institutional Heart Team. As proposed by several working groups, patients with major prosthetic dehiscence, severe hemolytic anemia, large or multiple PVLs, concomitant pathologies warranting a surgical intervention and low to moderate surgical risk should be referred for surgical treatment, whereas patients with unfavorable surgical anatomy (porcelain aorta, severe mitral annulus calcification) and high surgical risk should be primarily treated with an interventional approach [29–31]. According to current European guideline reoperation is recommended if PVL is related to endocarditis or causes hemolysis requiring repeated blood transfusions or leading to severe symptoms (Class of recommendation I, Level of evidence C) [32]. Transcatheter closure may be considered for PVLs with clinically significant regurgitation in surgical high-risk patients after Heart Team decision (Class of recommendation IIb, Level of evidence C) [32]. In patients without severe symptoms of HF and absence of hemolysis strategic observation and interventional risks needs to be weighed against the potential benefit of early closure (Fig. 5).

4.1. Surgical techniques for mitral PVL closure Reoperations for PVL closure are commonly performed via conventional median sternotomy and standard bicaval venous cannulation. Cardioplegia is administered antegrade and retrograde via cannulation of the coronary sinus. In patients with a history of radiation or bypass grafts crossing under the sternum right anterolateral thoracotomy in the fourth intercostal space can be performed with the particular limitation of limited access and sometimes unfeasible cross-clamping. In these cases, peripheral cannulation and endoclamping, as well as fibrillatory arrest, can be performed. Various techniques have been established achieving good mitral valve exposure; however, the standard left atriotomy and the transseptal approach are the most common access strategies. Exposure can be enhanced by incision of the pericardial reflections superiorly and inferiorly or transection of the superior vena cava [33]. Assessment of mitral valve function needs to be performed prior to surgery. In case of a regular mitral valve function and smaller leaks pledgeted suturing may be sufficient and risks associated with valve

Please cite this article as: S. Okutucu, M. Mach and A. Oto, Mitral paravalvular leak closure: Transcatheter and surgical solutions, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.06.012

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Fig. 5. Treatment algorithm for patients with mitral PVL.

replacement can be avoided. Different techniques closing smaller leaks are described using sutures with pledgets placed either at the atrial or ventricular side of the mitral valve or even at the right atrial side with the suture passing through the interatrial septum and the sewing ring of the prosthetic mitral valve [34–36]. Even placing sutures through the coronary sinus wall has been described [37]. Posterior PVLs can also be closed with pledgeted sutures passing through the posterior left atrial wall [34]. In case of residual PVLs, larger leaks or fibrotic tethering of the surrounding valve tissue leak closure often requires an (additional) autologous or bovine pericardial patch [38]. In the case of valve dysfunction, dehiscence or endocarditis valve replacement is necessary. Notably leak recurrence after valve re-replacement is not uncommon due to annulus damage or calcification impeding adequate suture placement. In such cases, the new prosthetic valve can be seated within a pericardial skirt sewn to the sewing ring. While annular patch sutures are placed in a standard fashion through the annulus and the sewing

ring, the pericardial skirt is sutured in a running fashion to the left atrium as additional sealing. Different surgical techniques for mitral PVL closure are shown in Fig. 6. Particular care must be taken during removal of the original (valve) sewing ring not to resect excessive annular tissue. In case of atrioventricular disruption of the posterior annulus section pericardial patch repair needs to be performed prior to annular suture placement [39]. A semicircular patch is sewn to the ventricular and atrial pericardium to reconstruct the mitral annulus (David technique) [40]. A different technique described by Carpentier uses atrioventricular figure-of-eight sutures to reconstruct the AV-junction [41]. However, care must be taken for the sutures not cutting through non-compliant ventricular tissue [42]. Overly aggressive bites of annular sutures can injure the circumflex artery and will significantly increase peri- and postprocedural morbidity and mortality [33]. Even though challenging, preservation of the subvalvular apparatus is also crucial in mitral reoperations.

Fig. 6. Transatrial mitral PVL closure: (A) if the leak is located towards the interatrial septum, it can be approached from the right atrial side of the interatrial septum and being aware of the location of the conduction bundle and atrioventricular node to provide more secure repair. Another technical strategy for the leak that is located at the aortomitral curtain (B), sutures can be placed through an aortotomy and after retraction of the aortic leaflets, the pledgeted sutures pass below the aortic annulus into the mitral prosthesis sewing ring. Pericardial skirt technique (C) for mitral valve replacement. Bovine pericardium can be fashioned as a skirt and sewn to the sewing ring of mitral prosthesis. Pericardial skirt is sewn to left atrium with running technique.

Please cite this article as: S. Okutucu, M. Mach and A. Oto, Mitral paravalvular leak closure: Transcatheter and surgical solutions, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.06.012

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While contractile function is improved, and posterior annulus disruption is avoided significant improvement in perioperative mortality has been shown [43]. Damage extension to the fibrous trigones may require replacement of the mitral as well as the aortic valve. This usually occurs only in combined aortic and mitral valve endocarditis and involves replacement of both valves. A pericardial patch can be used for the reconstruction of the intertrigonal space. The mitral valve prosthesis is secured to the annulus posteriorly, medially, and laterally as well as superiorly to the patch. The superior part of the patch is also used to reconstruct the medial aortic annulus where the aortic valve prosthesis is affixed. As perfect exposure is required for this procedure, an extended transseptal approach or transection of the superior vena cava and extension of the left atriotomy to the right superior pulmonary vein towards the dome of the left atrium is performed [42,44]. Due to its technical challenge, this procedure is famously referred to as “Commando procedure”. 4.2. Outcomes for surgical mitral PVL closure While a few studies have investigated the outcome of surgical PVL closure in a heterogeneous cohort of both aortic and mitral cases, only a few have studied the results of isolated PVL closure in mitral position [29,30,44–47]. As many patients referred for this type of procedure are in NYHA class III or IV (60–80%) due to HF and frequently present themselves with hemolytic anemia requiring transfusion (up to 40%) the peri- and postoperative mortality is significantly increased [29,45,48,49]. Repair has been described to be feasible in up to 76% of cases, whereas replacement was needed in around 30–50% of all cases [45,46,49,50]. For the majority of mitral valve re-replacements (82%) mechanical valves have been used [49]. The risk of in-hospital and early 30-day mortality is naturally increased as in most redo surgical cases and been described in recent literature in around 5–30% of treated patients [46,49]. Of note, Taramasso et al. [45] observed significantly higher rates of early mortality after surgical mitral PVL closure than aortic PVL closure (13% vs. 5%). While no specific risk factors have been described for early mortality after surgical mitral PVL repair, residual PVL, reoperation or reintervention due to recurrent PVL, active endocarditis, chronic steroid use, previous coronary bypass surgery, chronic renal, concomitant tricuspid valve surgery, and postoperative dialysis have been described by Said et al. [49] as risk factors for late mortality after isolated mitral cases. Taramasso et al. [45] on the other hand, found preoperative chronic renal insufficiency and more than one previous surgery prior to PVL repair to be predictive parameters for long-term mortality in their combined aortic and mitral cohort. In the retrospective analysis by Said et al. [49] overall survival at 1, 5- and 15 year after surgical mitral PVL repair was 83%, 62% and 16% respectively, while Bouhout et al. [50] described in their study of surgical PVL repair in the aortic and mitral position survival rates of 85%, 73% and 56% at 1, 5 and 10 years respectively. Equally disappointing long-term outcomes of only 40% of survivors after 12 years have been described in combined aortic and mitral cohorts [45]. Recurrence of PVL after surgical repair or valve replacement in mitral position has been described in 21%, with reintervention being 6% and reoperation in 9.2% of patients [49]. Notably, no difference in survival and recurrence of PVL has been described between PVL repair and replacement [49,51]. 4.3. Outcomes of surgical versus percutaneous mitral PVL closure Similar to surgical data for mitral PVL repair, most studies compared a heterogeneous cohort of aortic and mitral PVL patients regarding their either surgical or interventional therapy. Alkhouli et al. [30] compared surgery to percutaneous mitral PVL closure. This study indicates more complete occlusion of PVLs in the surgical cohort with the downside of a higher rate of in-hospital mortality compared to percutaneous

repair. However, as typical in such comparisons, an allocation bias cannot be denied to a certain extent [30,45]. Patients referred for surgical repair are often younger, had a longer time between index surgery and reoperation, and a higher prevalence of endocarditis and chronic renal insufficiency. According to Alkhouli et al. [30], risk-adjusted predictors of in-hospital mortality were chronic renal failure, active endocarditis and severe mitral annulus calcification. Evaluating completeness of PVL occlusion, surgery has been demonstrated higher success rates with mild or less residual regurgitation in 92% whereas only observed in around 70% treated via a percutaneous interventional approach [30]. The difference in repeat intervention or surgery after PVL occlusion in the known literature is only numerical (11.3% in the interventional cohort vs. 17.2% for surgically treated patients), however, the time to repeat intervention is significantly shorter in percutaneous cohorts (about 6 months for interventional treatment vs. 3,5 years for surgical treatment). These findings are based on the different causes of repeat intervention. While residual PVL and persistent severe hemolysis are the major drivers for early re-intervention after percutaneous PVL closure, recurrence of PVL is the leading cause for repeat treatment after surgical closure [30]. As already described for surgical studies, long-term survival after PVL closure in mitral position is profoundly impaired. Nonetheless, long-term survival after percutaneous PVL closure seems to be equally limited [30,45,52]. As the current trend leads more and more towards interventional therapy forms, institutional practice patterns may differ due to operator and center experience. However, a multidisciplinary heart team approach should be mandatory in the treatment of these complex patients. 5. Transcatheter techniques Mitral percutaneous PVL closure can be performed using the antegrade transfemoral (venous, transseptal), retrograde transfemoral (arterial), or transapical (TA) access [5]. The procedure is typically performed under general anesthesia using TEE and fluoroscopic guidance. Antegrade transseptal (TS) approach is generally the first choice for mitral PVL closure. A lower rather than higher TS puncture is desirable. The angle between the transseptal puncture and the PVL is important for crossing the defect with the delivery sheath. Steerable sheaths, such as the Agilis™ sheath (St. Jude Medical, St. Paul, MN, USA), allows to direct the sheath in front of the PVLs and facilitates wire passage. Usually, a 0.035″ hydrophilic wire is used to cross the PVLs (such as Glidewire®; Terumo Medical Corp., Shibuya, Japan). The hydrophilic wire is then exchanged for a support wire (such as Back-up Meier™ guidewire; Boston Scientific, Marlborough, MA, USA) [53]. The delivery sheath is then advanced through the defect over the support guidewire. Radiofrequency (RF) ablation catheters with high steerability such as (RF Marinr® MR, Medtronic, USA) might also be used to cannulate PVLs and advance sheath over the ablation catheter (Fig. 7). Placement of delivery catheters sometimes might be challenging especially in serpiginous and calcific defects. In such instances, transcatheter rails provide greater support, especially when large sheaths are introduced [9]. Following placement of a guidewire across the PVL, the wire is snared and then exteriorized to provide the operator with both ends of the wire and greater support for delivery catheter placement [9]. Once the delivery sheath is across the defect, the ventricular part of the device is deployed. The atrial part is then deployed after retracting the sheath. The efficacy of the implant is controlled by TEE. Placement of the device specific occluder can be performed with 2 different techniques. In waist technique, cap body of the device is used to fill the defect whereas in cap technique disk of tightly woven nitinol is used to cover the PVL [44] (Fig. 8). A “tug test” is performed and free movement of the prosthetic valve leaflets (in case of a mechanical prosthesis) is confirmed before device deployment [53]. If needed, more than one device can be implanted sequentially. In the retrograde approach for mitral PVL closure, the defect is crossed with a wire from left ventricle to

Please cite this article as: S. Okutucu, M. Mach and A. Oto, Mitral paravalvular leak closure: Transcatheter and surgical solutions, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.06.012

S. Okutucu et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx

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Fig. 7. Steerable Agilis™ sheath (St. Jude Medical, St. Paul, MN, USA) (A); cannulation of PVL with RF catheter with high steerability (RF Marinr® MR, Medtronic, USA) (B) and successful closure of the defect (C).

the left atrium, and a loop is established. The delivery sheath is advanced over the loop from the left atrium to the left ventricle through the leak, and the closure device is deployed [16]. Transapical approach is a good alternative for patients with severe transfemoral access difficulties, in those where closure is not possible via transfemoral access [52,53]. Transapical access requires general anesthesia, in order to perform a mini-thoracotomy allowing direct exposure of the left ventricular apex. It is rarely performed by direct apical puncture. To define the best place for incision or puncture it is advisable to do a CT and coronary angiography to avoid damage to the coronary arteries. When the left ventricular apex is punctured directly, a 0.018″ wire is introduced through the needle and a 5–6 Fr introducer is placed in the LV. With the help of a Judkins right or a multipurpose catheter and a hydrophilic wire, the leak is crossed, and the wire is exchanged for a high support 0.035″ wire. When the device has been advanced through the sheath, the stability of the device has been tested, the prosthesis discs are found to be functioning well and the flow through the leak has disappeared or decreased sufficiently, the device is released. The sheath is removed from the muscular apex with self-sealing of the myocardium (in case of small sheaths) or percutaneous closure of the puncture site by the implantation of an AMPLATZER Occluder device (usually VSD or a duct occluder) [16,52,53]. Taramasso et al. [52] reported satisfactory acute results of a small series of 17 very high-risk patients who underwent mitral PVL closure

through the transapical route. Notably, 30-day mortality was 0%, with an acute procedural success of 94%, and these results compared favorably with open heart surgery. In another series consisting of 43 patients by Ruiz et al. [18] where the TA access was used for the majority of mitral PVLs, technical success rate for device deployment in mitral PVLs was 89%. In a retrospective cohort study, Zorinas et al. [25] reported 19 patients underwent surgical transapical catheter-based mitral PVL closure with the Occlutech PLD Occluder. A reduction of paravalvular regurgitation to a mild or lesser degree was achieved in 18 (95%) patients. There were no strokes or myocardial infarctions at follow-up. There were no deaths at 30 days after the procedure [25]. 6. Device choice The ideal device for PVL closure should be retrievable and repositionable, show good conformability, have a low-profile deliverability and result in complete sealing after implantation. A number of AMPLATZER devices which are not specifically designed for PVL closure have been used. However, most of these devices present several potential limitations. The only devices specifically dedicated to PVL closure are the crescent-shaped AMPLATZER Vascular Plug III (AVP III; St. Jude Medical, St. Paul, MN, USA) and Occlutech paravalvular leak device (PLD) (Occlutech, Helsingborg, Sweden). The AVP III has an oval shape, multiple layers, more and thinner wires, smaller pore size,

Fig. 8. Major access routes (A), waist (B) and (C) cap techniques for transcatheter mitral PVL closure.

Please cite this article as: S. Okutucu, M. Mach and A. Oto, Mitral paravalvular leak closure: Transcatheter and surgical solutions, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.06.012

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improved surface contact and faster occlusion compared to other AMPLATZER devices. Due to these characteristics and design, the AVP III is potentially an ideal device for this procedure and it has recently been used off-label for PVL closure, mainly in Europe. Nietlispach et al. [12], who described the initial experience with this device, obtained technical success in 100% of the five patients in whom it was implanted. Cruz-Gonzalez et al. [54] reported 90.9% success in 33 patients and Smolka et al. [55] reported 93.9% success in 46 patients. Occlutech PLD is a double-disc device which comes in either a square or a rectangular shape, one disc being slightly larger than the other. The two discs are connected by a round or elliptical waist or a small connector. Recently, Occlutech PLD obtained CE approval for its device specifically designed for PVL closure [56]. Table 1 lists the different devices and their specific features and indications. 7. Outcomes Outcomes depends on patient factors, anatomical factors, and on the volume and experience of the operators [56]. García et al. [56] recently assessed the safety and efficacy of percutaneous closure of PVLs and searched the predictors of procedural success and early complications. Global technical success of the procedures was 87% and procedural success occurred in 73% of the patients. Transfemoral access was used in most of the patients (94%) and the antegrade transseptal approach was used in most of the patients. In multivariate analysis, the independent predictors for procedural success in mitral lesions were the type of device used (AMPLATZER AVP III vs. others, HR 2.68 [1.29–5.54]) and the number of procedures performed at the centre (top quartile vs. others, HR 1.93 [1.051–3.53]) [56]. Alkhouli et al. [57] recently reported procedural success, in hospital outcomes, and midterm mortality rates in a total of 231 patients underwent percutaneous mitral PVL repair. Around 70% of patients had mild or no PVL after the procedure. Compared with those who had more than mild residual PVL, patients with mild or no residual

PVL had lower rates of repeat surgical interventions and lower allcause mortality. Survival at 3 years was 61% in patients who had mild or no residual leak and 47% in patients with higher grade of residual PVL. These findings imply that successful percutaneous PVL closure associates with significant midterm survival benefit. In a study reported by Lloyd et al. [58] percutaneous mitral PVL closure was associated with significant reductions in left atrial and pulmonary arterial pressures and an increase in cardiac index. They found that higher left atrial pressures during and following percutaneous mitral PVL closure were independent predictors of poor survival. These findings reflect that hemodynamic effects might underlie the clinical benefits of PVL closure and might be useful for intraprocedural guidance. Millan et al. [59] evaluated the relationship between a successful PVL closure and clinical outcomes A successful PVL closure was associated with a lower cardiac mortality rate (odds ratio [OR], 0.08; 95% credible interval [CrI], 0.01–0.90) and with a superior improvement in functional class or hemolytic anemia, compared with a failed intervention (OR, 9.95; 95% CrI, 2.10–66.73). Panaich et al. [60] assessed the effect of percutaneous PVL closure on hemolysis. They found that percutaneous PVL closure was associated with modest improvement in anemia, blood transfusion requirements and/or hemolysis markers. This benefit was most significant in patients with mechanical valves. The degree of residual PVL after closure was not associated with improvement in hemolytic anemia. There is usually no complication N80% of the cases [56]. The most frequent adverse events are vascular complications and minor bleeding (~8%). Rarely device might be observed (~3%) successfully snared and retrieved. Pericardial effusion might be detected around 1% of cases. In SpanisH real-wOrld paravalvular LEaks closure (HOLE) registry, the overall major adverse events rate (death, stroke, and emergency surgery) at 30 days was 5.6%. Similarly, Sorajja et al. [61] in their initial experience reported a 30-day complication rate of 5.2% (sudden and unexplained death, 1.7%; stroke, 2.6%; emergency surgery, 0.9%) in

Table 1 Different PVL closure devices and their specific features and indications. Name of the device

Properties

ASO

▪ Sizes 4–40 mm (every 1mm up to 20mm, N20 mm, every 2 mm) ▪ Allows closure of large defects ▪ Large distance between the waist and the discs (12-14 mm in most devices) ▪ Risk of interference with mechanical leaflets

VSD Occluder

▪ Sizes up to 18 mm, allows closure of large defects ▪ Round shape and might not be suitable for non-round shapes ▪ Risk of interference with mechanical leaflets

ADO

▪ Sizes up to 5–16 mm distal end and 4–14 mm proximal ▪ Only one retention skirt, which could increase the risk of embolization

AVP II

▪ May be the device of choice in long tunnel-shaped leaks with a large central cavity ▪ Round shape and might not be suitable for non-round shapes

AVP III

▪ Nitinol-based device with an elliptical lobe that adapts to the often crescent-shaped defects ▪ 9 sizes ranging from 4×2 mm to 14×5 mm

AVP IV

▪ Small AVP 4 can be deployed through a 4 Fr diagnostic catheter ▪ Often used in PVL closure after TAVI

PLD Occluder

▪ Two different shapes: square or rectangular shape ▪ CE-marked device dedicated to closure of paravalvular leaks

Figure

ADO, Amplatzer Duct Occluder; ASO, Amplatzer Septal Occluder; AVP, Amplatzer Vascular Plug; PLD, paravalvular leak device; VSD, ventricular septal defect.

Please cite this article as: S. Okutucu, M. Mach and A. Oto, Mitral paravalvular leak closure: Transcatheter and surgical solutions, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.06.012

S. Okutucu et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx

115 patients, and Calvert et al. [62] described a hospital mortality of 3.9% in 259 patients. 8. Conclusions PVL is an important complication after valve replacement and might lead to serious clinical results, including HF and hemolysis. Multimodality imaging including TEE and cardiac CT are important in establishing the diagnosis and defining the size, location, and mechanism of PVL. PVL closure often requires Heart Team approach. Surgery is appropriate for patients with PVL due to endocarditis or large valve dehiscence. Percutaneous treatment of PVL has significantly less morbidity than redo surgery and should represent the first-line therapy for most patients with symptomatic PVL. Better dedicated devices and larger case series are needed to develop these procedures further and improve outcomes. Declaration of Competing Interest This study was not supported by any funding. The authors declare that they have no conflict of interest. Acknowledgements The authors would like to thank Dr. Francesco Maisano, Dr. Maurizio Taramasso and other CAS - Mitral and Tricuspid Valve Structural Interventions faculty and participants for enabling positive research and academic environment during writing process of this manuscript. References [1] Noble S, Jolicoeur EM, Basmadjian A, Levesque S, Nozza A, Potvin J, et al. Percutaneous paravalvular leak reduction: procedural and long-term clinical outcomes. Can J Cardiol 2013;29:1422–8. [2] Giblett JP, Rana BS, Shapiro LM, Calvert PA. Percutaneous management of paravalvular leaks. Nat Rev Cardiol 2019;16:275–85. [3] Davila-Roman VG, Waggoner AD, Kennard ED, Holubkov R, Jamieson WR, Englberger L, et al. Prevalence and severity of paravalvular regurgitation in the artificial valve endocarditis reduction trial (AVERT) echocardiography study. J Am Coll Cardiol 2004;44:1467–72. [4] Gafoor S, Franke J, Bertog S, Lam S, Vaskelyte L, Hofmann I, et al. A quick guide to paravalvular leak closure. Interv Cardiol 2015;10:112–7. [5] Gafoor S, Steinberg DH, Franke J, Bertog S, Vaskelyte L, Hofmann I, et al. Tools and techniques–clinical: paravalvular leak closure. EuroIntervention 2014;9:1359–63. [6] Kim MS, Casserly IP, Garcia JA, Klein AJ, Salcedo EE, Carroll JD. Percutaneous transcatheter closure of prosthetic mitral paravalvular leaks: are we there yet? JACC Cardiovasc Interv 2009;2:81–90. [7] Echevarria JR, Bernal JM, Rabasa JM, Morales D, Revilla Y, Revuelta JM. Reoperation for bioprosthetic valve dysfunction. A decade of clinical experience. Eur J Cardiothorac Surg 1991;5:523–6 [discussion 7]. [8] Piechaud JF. Percutaneous closure of mitral paravalvular leak. J Interv Cardiol 2003; 16:153–5. [9] Sorajja P. Mitral paravalvular leak closure. Interv Cardiol Clin 2016;5:45–54. [10] Sorajja P, Cabalka AK, Hagler DJ, Rihal CS. The learning curve in percutaneous repair of paravalvular prosthetic regurgitation: an analysis of 200 cases. JACC Cardiovasc Interv 2014;7:521–9. [11] 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;4:314–21. [12] Nietlispach F, Johnson M, Moss RR, Wijesinghe N, Gurvitch R, Tay EL, et al. Transcatheter closure of paravalvular defects using a purpose-specific occluder. JACC Cardiovasc Interv 2010;3:759–65. [13] Feldman T, Nietlispach F. Surgical vs. percutaneous approaches to paravalvular leak: is closure too little too late, or just not soon enough. Catheter Cardiovasc Interv 2016;88:634–5. [14] Nietlispach F, Maisano F, Sorajja P, Leon MB, Rihal C, Feldman T. Percutaneous paravalvular leak closure: chasing the chameleon. Eur Heart J 2016;37:3495–502. [15] Pate GE, Al Zubaidi A, Chandavimol M, Thompson CR, Munt BI, Webb JG. Percutaneous closure of prosthetic paravalvular leaks: case series and review. Catheter Cardiovasc Interv 2006;68:528–33. [16] Garcia E, Sandoval J, Unzue L, Hernandez-Antolin R, Almeria C, Macaya C. Paravalvular leaks: mechanisms, diagnosis and management. EuroIntervention. 2012;8 Suppl Q:Q41–52. [17] Zamorano JL, Badano LP, Bruce C, Chan KL, Goncalves A, Hahn RT, et al. EAE/ASE recommendations for the use of echocardiography in new transcatheter interventions for valvular heart disease. Eur Heart J 2011;32:2189–214.

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