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Heart Online First, published on February 12, 2015 as 10.1136/heartjnl-2014-306270 Review
Percutaneous repair of paravalvular prosthetic regurgitation: patient selection, techniques and outcomes Paul Sorajja, Richard Bae, John A Lesser, Wesley A Pedersen Center for Valve and Structural Heart Disease, Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA Correspondence to Dr Paul Sorajja, Center for Valve and Structural Heart Disease, Minneapolis Heart Institute, Abbott Northwestern Hospital, 920 East 28th ST, Minneapolis, MN 55407, USA; [email protected] Received 10 September 2014 Revised 9 January 2015 Accepted 21 January 2015
To cite: Sorajja P, Bae R, Lesser JA, et al. Heart Published Online First: [please include Day Month Year] doi:10.1136/heartjnl2014-306270
ABSTRACT Paravalvular prosthetic regurgitation is common, affecting 5–10% of surgical prostheses and 40–70% of transcatheter valves. While many patients may suffer no significant morbidity, paravalvular prosthetic regurgitation can lead to heart failure and haemolytic anaemia, and, in some studies, has been associated with impaired survival. Over the past several years, percutaneous repair of paravalvular prosthetic regurgitation has been demonstrated to be a highly efficacious therapy. When performed in experienced centres, procedural success with percutaneous repair occurs in 90% of patients. Due to the complex nature of the techniques, there is a significant learning curve with a high potential for prolonged procedures (∼2.5 h) and complications (∼5%), although death is rare (∼0.5%). Percutaneous repair of paravalvular prosthetic regurgitation requires a close collaboration between imaging specialists, surgeons and the interventional operators. Importantly, successful percutaneous repair obviates the need for open surgical correction, which can be high risk or prohibitive due to the need for reoperation in the setting of comorbidities. Herein, we discuss appropriate patient selection, the catheter-based techniques and outcomes of percutaneous repair for symptomatic paravalvular prosthetic regurgitation. Paravalvular regurgitation occurs in 5–10% of surgical prostheses and 40–70% of patients who undergo transcatheter valve replacement.1–5 Paravalvular prosthetic regurgitation can cause symptoms of heart failure or haemolytic anaemia, and, in some studies of transcatheter valve therapy, has been associated with impaired survival.3 While the traditional treatment for paravalvular prosthetic regurgitation has been open surgery, percutaneous approaches are now an established therapy for symptomatic patients.6 It is important to note that open surgical repair always necessitates reoperation, and that these patients frequently have severe morbidities that can significantly increase the surgical risk. Open surgery also may not be successful due to tissue characteristics that could have predisposed towards the original development of the paravalvular regurgitation. Thus, percutaneous therapy is inherently attractive as a relatively less invasive option for many patients with paravalvular regurgitation and now is frequently considered as primary therapy for eligible patients.
PATIENT EVALUATION AND SELECTION Patients who may be considered for percutaneous repair of paravalvular prosthetic regurgitation
should undergo a comprehensive, multidisciplinary evaluation within a centre where there is close collaboration between the clinical cardiologist, interventionalist, surgeon and imaging specialists.6 For all patients, the surgical risk with stratification tools and consultation should be considered. Repeat surgery will not be prohibitive in many patients, even though the reoperative risk will be increased relative to the initial surgery.7 8 When paravalvular prosthetic regurgitation is known or suspected, patients should be evaluated for both active endocarditis and haemolytic anaemia, even when there are not findings suspicious for these disorders. Active endocarditis is a contraindication to device occluder placement. The presence of haemolytic anaemia necessitates a very high degree of closure (ideally complete) and should be known when discussing therapeutic options during consent. Echocardiography is the primary imaging modality for the evaluation of paravalvular regurgitation. While 2D echocardiography is widely used as the initial screening tool, 3D studies with colour imaging are particularly useful in these patients. 3D echocardiography is less susceptible to interobserver variability for quantitation and provides detailed morphology that is used to plan and guide percutaneous repair.9–11 Notably, in some patients, acoustic shadowing can pose challenges for visualising paravalvular regurgitation (figure 1). Additional non-invasive imaging can be performed with cardiac CT or MRI, where the spatial resolution is not limited by imaging planes. Cardiac CT is highly accurate for determining the presence of paravalvular leaks, their size, orientation and surrounding calcification. These imaging studies also provide information regarding camera setup in the catheterisation laboratory and thus help facilitate the success of percutaneous closure (see ‘CT guidance’ section). Cardiac MRI has been demonstrated to have incremental utility over 2D echocardiography for quantitation of regurgitation, with less susceptibility to interobserver variability.9 12 Goals of the imaging examination are to determine the location and severity of the paravalvular regurgitation (including size and distance of the defect from the prosthesis annulus), the degree of ventricular compensation, and to exclude central valvular involvement and concomitant indications for open surgery. Of note, while echocardiography has been used to evaluate valvular regurgitation for decades, the echocardiographic criteria for quantification of paravalvular prosthetic regurgitation are less well studied.13–15 In patients with inconclusive non-invasive imaging studies, evaluation in the
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Review Figure 1 Echocardiographic imaging of paravalvular regurgitation. In some cases, acoustic shadowing can pose challenges in echocardiography for the detection of paravalvular regurgitation. (Top and middle) Transoesophageal echocardiography immediately after transcatheter implantation of a 26 mm Sapien valve shows mild central regurgitation (arrow), but no significant paravalvular regurgitation. Acoustic shadowing (top, arrow) of the anterior paravalvular area is present. (Bottom) Significant anterior paravalvular regurgitation is evident on apical long-axis view using transthoracic echocardiography (arrow). Ao, aorta; LA, left atrium; RA, right atrium.
cardiac catheterisation laboratory with a detailed haemodynamic assessment and angiography should be performed. For all patients, clinical judgement regarding severity of these defects and the likelihood of associated symptoms must be 2
exercised. It is important to note that defects that are not severe can still be haemodynamically significant and may benefit from therapy, but the decision to pursue such treatment should be individualised. In this regard, invasive haemodynamic studies Sorajja P, et al. Heart 2015;0:1–9. doi:10.1136/heartjnl-2014-306270
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Review with direct examination of ventricular filling pressures at rest and exercise may be helpful in the evaluation. In the most recent American College of Cardiology Foundation/American Heart Association guidelines on valvular heart disease, percutaneous repair of paravalvular prosthetic regurgitation is recommended for patients with severe symptoms or haemolysis, who are at high risk of surgery and who have suitable anatomic features (class IIa recommendation).6 In addition, it is our belief and that of many others that percutaneous repair may be considered for asymptomatic patients with evidence of attributable ventricular decompensation, and for patients who are not at high risk of open surgery if appropriate informed consent has been obtained in a shared decisionmaking process. Percutaneous repair should not be performed in centres without expertise in the procedure due to its considerable complexity, nor for patients with active endocarditis, a rocking prosthesis or significant valvular regurgitation.
PERCUTANEOUS REPAIR TECHNIQUES Device occluders Percutaneous repair of paravalvular regurgitation requires offlabel use of occluders. The most commonly used devices are the Amplatzer vascular plugs (AVP) (St. Jude Medical, Fridley, Minnesota, USA). These devices are made of self-expanding nitinol, deliverable through small calibre catheters (eg, 4 Fr), and have retention discs to help reduce the risk of embolisation after deployment. While the AVP-2 and AVP-4 devices are used in the USA, AVP-3 is available only in Europe. Other commonly used devices include the Amplatzer muscular ventricular septal defect and ductal occluders. Both of these latter occluders require relatively larger sheaths for delivery, but have been successfully employed in select cases. Of note, catheter accommodation for the various device occluders is not described well in the manufacturer’s labelling. Several guidelines, which have arisen from trial and error, are noteworthy: (1) a 6 Fr multipurpose guide catheter (Cordis, Bridgewater, New Jersey, USA) will accommodate a 12 mm AVP-2; (2) a 4 Fr diagnostic multipurpose catheter or Glidecath (Terumo Medical, Somerset, New Jersey, USA) will accommodate a 4 mm AVP-4; (3) a 4 Fr Cook Flexor Shuttle sheath (Cook Medical, Bloomington, Indiana, USA) will accommodate an 8 mm AVP-2; and (4) a 6 Fr Cook Flexor Shuttle will accommodate a 12 mm AVP-2 and a 0.03500 extra-stiff Amplatz wire simultaneously, or two 0.03200 extra-stiff Amplatz wires together.
Aortic paravalvular regurgitation For patients with aortic paravalvular regurgitation, the most common approach for percutaneous repair is retrograde via the femoral artery (figure 2). Selection of the echocardiographic modality is dependent on the location of the defect and the need to minimising acoustic shadowing of the regurgitant jet (transoesophageal for posterior defects; transthoracic for anterior ones). Intracardiac echocardiography of the aortic prosthesis from the right atrium also can be performed; manipulation of the catheter into the RV outflow tract may provide additional imaging details in these patients. The image intensifier should be positioned with no overlap between the defect and the aortic prosthesis. This positioning can be approximated (eg, left anterior oblique cranial for posterior defects; right anterior oblique caudal for anterior defects) or accurately determined from CT imaging. Without this positioning, it is difficult to determine whether the guidewire is being passed into the defect external to the prosthesis. For biplane Sorajja P, et al. Heart 2015;0:1–9. doi:10.1136/heartjnl-2014-306270
laboratories, the additional imaging intensifier is positioned en face to help with external placement of the wire, though this position can be difficult to attain with aortic prostheses. The defect is approached with a steerable coronary catheter (eg, 6 Fr Amplatz left or multipurpose catheter). An angled-tip, exchange-length (260 cm) hydrophilic wire (Glidewire, Terumo) is placed through the defect and often passed antegrade through the aortic valve in the event that snaring for a rail is required. Once the wire is across, a guide catheter is advanced into LV. Selection of the guide is dependent on (1) the size and number of device occluders that are needed, (2) difficulty encountered in passing the catheter across the defect and (3) need for an anchor wire. With the guide catheter in LV, the device occluder is extruded with retention discs positioned on the ventricular and aortic sides of the defect or, as frequently with AVP-4, wholly within the defect. The final assessment must include evaluation for prosthetic leaflet impingement and residual regurgitation. Angiography should also be considered to exclude arterial occlusion for patients requiring large device occluders and those with small aortic sinuses, low coronary height or defects located near the coronary ostia. Once the final assessment is satisfactory, the device occluders are released.
Mitral paravalvular regurgitation For patients with mitral paravalvular regurgitation, percutaneous repair usually is performed with general anaesthesia and transoesophageal echocardiography. The most commonly used approach is femoral venous access with transseptal puncture and antegrade cannulation of the defects from the left atrium. Alternatively, direct transapical puncture or a retrograde approach (via the femoral artery) with retrograde cannulation from LV also can be successful.16–18 For the antegrade approach, standard transseptal techniques with guidance from fluoroscopy and echocardiography are used to access the left atrium. In patients with posterior or medial mitral paravalvular defects, the relatively abrupt angulation to the defect can pose challenges for catheter engagement; a posterior or superior position for the puncture to gain height on the mitral valve can be beneficial in these cases. A steerable 8.5 Fr guide (Agilis catheter, St. Jude) is loaded with a telescoped catheter system, consisting of a 6 Fr 100 cm multipurpose guide and a 5 Fr 125 cm multipurpose diagnostic catheter (figure 3). The steerable guide can be small curved or medium curved; small-curved guides are particularly helpful for medial defects. This system is steered towards the defect, which is crossed with the Glidewire (Terumo). Fluoroscopy should demonstrate positioning of the steerable guide and guidewires external to the prosthesis ring. The two multipurpose catheters are placed sequentially into LV, followed by removal of the diagnostic catheter (figure 3). A device occluder can be passed through the 6 Fr guide, which can accommodate a 12 mm AVP-2. Alternatively, the guide can be exchanged over a 0.03200 extra-stiff Amplatz wire for a larger catheter (eg, 90 cm, 6–8 Fr Cook Flexor Shuttle) that enables either multiple device placements or anchor wiring. Similar to treatment of aortic defects, the distal retention disc of the occluder is extruded from the guide into LV, followed by straddling of the defect with the retention discs on both sides (figure 3). Once leaflet impingement has been excluded on both echocardiography and fluoroscopy, the device occluder(s) is released. Guidance from comprehensive transoesophageal echocardiography is essential to the success of the procedure. The echocardiographer and interventional cardiologist should communicate freely with regards to the location of the defect and its 3
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Review
Figure 2 Percutaneous repair of paravalvular aortic prosthetic regurgitation. Transoesophageal echocardiography demonstrates severe anterior aortic paravalvular regurgitation (arrowheads) involving a bi-leaflet mechanical prosthesis in a long-axis (A) and short-axis view (B). (C) An AL-1 diagnostic catheter is steered towards the defect, which is then crossed with a 260 cm, angle-tipped, extra-stiff Glidewire (arrowhead). (D) Over the Glidewire, an 8 Fr Cook Flexor Shuttle (arrowhead) is passed into LV, followed by placement of two 0.03200 extra-stiff Amplatz wires. (D) Over these two wires, two separate delivery sheaths (6 Fr Shuttle) are advanced into LV. The distal retention discs of two 10 mm Amplatzer vascular plug-2 are extruded into LV followed by apposition against the LV side (E) and deployed (F, arrowhead). The final view is chosen to demonstrate normal prosthetic leaflet motion. Postprocedural transoesophageal echocardiography in long-axis (G) and short-axis views (H) demonstrates mild residual regurgitation. Ao, aorta; LA, left atrium; RA, right atrium.
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Review Figure 3 Percutaneous repair of paravalvular mitral prosthetic regurgitation. An 8.5 Fr steerable sheath (Agilis catheter) is placed with transseptal puncture in the left atrium followed by advancement of a telescoped 100 cm 6 Fr multipurpose guide and 125 cm 5 Fr multipurpose diagnostic catheter. The sheath is used to steer the catheters and Glidewire towards anterolateral defect, which is then crossed (A, arrow). A 10 mm Amplatzer vascular plug-2 is extruded into LV (B, arrow), then positioned and deployed across the paravalvular defect (C) and deployed (D, arrow). For a medial defect, a retrograde approach is used, in which the wire is passed from LV into the left atrium, where it is snared with a 15 mm gooseneck (E, arrow). Over this rail, a delivery sheath is used to place two additional devices (F, arrows). Transoesophageal echocardiography performed shows the two paravalvular defects before device placement (G), during wiring of the defect (I) and after device placement (H and J). LA, left atrium.
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Review Figure 4 Transcatheter rail for aortic paravalvular regurgitation repair. The defect is wired retrograde with a Glidewire (A, arrow), which is then passed antegrade through the aortic prosthesis into the descending aorta. A 15 mm gooseneck snare is used to grasp the soft portion of the wire (B, arrow), which is then exteriorised. Tension on the exteriorised wire is used for support to place delivery catheters (C, arrow). Initial angiography suggests the possibility of occlusion of the left coronary artery by the Amplatzer vascular plug-2 (D), but subsequent angiography demonstrates sufficient distance to the coronary ostium (E). The occluder is then released (F).
cannulation. Some operators have proposed a clock-face method for this communication; this approach can be challenging due to the opposite viewpoints of fluoroscopy versus the traditional left atrial surgical view obtained by transoesophageal echocardiography. A different method relies on anatomically correct terminology (anterior vs posterior, lateral vs medial) and triangulation between the aortic valve (ie, anterior), left atrial appendage (ie, anterolateral) and atrial septum (ie, medial).19 For patients with mechanical valves, the location of the prosthetic commissures also can assist with orientation. In the retrograde approach from the femoral artery, a coronary catheter (eg, Judkins right, Amplatz left or right, or internal mammary) is placed into LV and oriented posterior towards the defect. This technique can be used when the transseptal approach is not successful, especially if the defect is located medially. The defect can be crossed with relatively softer wires, such as 0.01400 or 0.01800 coronary guidewires if the Glidewire proves to be too stiff for passage. In the transapical technique, defect cannulation and device placement is similar to the 6
antegrade approach. CT guidance with fusion imaging also has been demonstrated to be beneficial when performing the apical puncture and for steering towards the paravalvular defect (see section ’CT guidance’).
Transcatheter rails Placement of guide catheters can be challenging due to the serpiginous and often calcific nature of the paravalvular defects. In these instances, transcatheter rails can be used for greater support for catheter passage. Originally described for the treatment of congenital heart lesions, transcatheter rails are created by snaring of a guidewire that has been placed across the paravalvular defect followed by exteriorisation to provide the operator with both ends of the wire. The transcatheter rail can be placed left atrial–ventricular– aortic or left atrial–ventricular–apical for mitral paravalvular defects (figures 4 and 5). For aortic paravalvular defects, the rail can be easily placed aortic–ventricular–aortic, or, in select cases, aortic–ventricular–apical or left atrial–ventricular–aortic. Once Sorajja P, et al. Heart 2015;0:1–9. doi:10.1136/heartjnl-2014-306270
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Review the rail has been created, the operator can advance a guide catheter with support from an assistant who provides tension on both ends of the wire. When creating transcatheter rails, it is important to note that injury to surrounding structures can easily occur from guidewire tension. Harm can result from damage to the prosthetic or native leaflets, myocardial injury, severe bradycardia from atrioventricular node pressure and disruption of the mitral valve apparatus from chordal entanglement. Thus, transcatheter heart rails should only be performed with experienced operators and with careful haemodynamic monitoring and simultaneous echocardiography.
Multiple device placement and anchor wiring Paravalvular defects frequently are eccentric and in close proximity to the surgical sewing ring. As a result, successful closure can be challenging with the use of large occluders as device overhang can result in leaflet impingement of the valve, particularly with mechanical prostheses. Alternatively, multiple, smaller device occluders can be used through an anchor wire technique. In these instances, a large bore guide catheter (eg, a 6 Fr or larger Cook Flexor Shuttle) is placed into the ventricle once the defect is crossed with a hydrophilic guidewire. This guide catheter can accommodate multiple, extra-stiff guidewires that can then be used to place the delivery catheters either simultaneously (eg, two 6 Fr multipurpose guides) or sequentially over each wire. The anchor wire technique is also useful for maintaining a position across the paravalvular defect in the event that an occluder needs to be exchanged for different or multiple other devices. If anchor wiring is used, large bore sheaths are required to accommodate the multiple delivery catheters and
wires. The DrySeal sheath (W.L. Gore, Flagstaff, Arizona, USA), with its inflatable cuff, is uniquely suitable for maintaining haemostasis for this purpose.
CT guidance Cardiac CT easily identifies the site of paravalvular regurgitation and can assist with percutaneous closure. Imaging is performed with contrast, ECG-gating ( prospective or retrospective), a slice thickness of 0.5 or 0.6 mm for maximal spatial resolution and three or more reconstruction intervals to accurately identify the defect. Using information from echocardiography, the CT scan is reconstructed with views of exit point of the regurgitant jet, whose paravalvular continuity can then be examined (figure 6). Imaging with CT can help with sizing of the defect, its course, as well as provide information on surrounding calcification. For patients with bioprosthetic valves, CT imaging can also be used to examine the leaflet morphology to determine valvular contribution to regurgitation. This incremental utility may be of particular clinical benefit when there is significant acoustic shadowing on echocardiography. Fusion CT imaging can be used to facilitate percutaneous closure.18 In this technique, CT data are co-registered to cardiac structures (ie, chambers, valves, coronary arteries), enabling overlay onto the fluoroscopy screen. Fusion CT imaging is then used to guide access (transseptal antegrade vs retrograde apical), defect wiring and device placement.
CLINICAL OUTCOMES While the first report of percutaneous repair of paravalvular regurgitation was published in 1992, the vast majority of experience with the therapy has been in the past seven years.20
Figure 5 Transcatheter rail for mitral paravalvular regurgitation repair. (Top left) The defect is wired with a Glidewire (arrow) antegrade from the left atrium (LA). The wire can be snared in LV, but passage into the aorta is preferable in order to avoid potential entanglement of the snare with the mitral chords (top right). Over this rail, tension on both ends of the wire facilitates passage of an 8 Fr Cook Flexor Shuttle across the paravalvular defect (C, large arrow). The wire is left in place to facilitate multiple device placement (C, small arrow, and D).
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Review Figure 6 Guidance of paravalvular repair using CT. CT with contrast demonstrates a paravalvular defect in the posterior/superior aspect of Sapien valve (top left). The structures are aligned with a view of the defect immediately exterior and parallel to the valve prosthesis (top right). These angles are provided to a operator, who places the image intensifier in the same position and then wires the defect (middle left). A 12 mm Amplatzer vascular plug-2 is placed (middle right). (Bottom) Transoesophageal echocardiography demonstrates the paravalvular leak before (left, arrow) and after closure (right, arrow). Ao, aorta; LA, left atrium.
Procedural success, using a strict definition of reduction to mild regurgitation or less and no major adverse events, occurs in ∼80% of patients (∼90% for moderate residual regurgitation or less).21 22 Complications are relatively infrequent. In a series of 115 patients, the 30-day rate of adverse events was 1.7% for sudden or unexplained death, 2.6% for stroke, 0.9% for emergency surgery and 5.2% for periprocedural bleeding.22 Periprocedural bleeding can arise from cardiac perforation, particularly with apical puncture, as well as use of large vascular access sheaths and during bridging anticoagulation.23 Of note, closure of apical puncture sites with vascular plugs or surgical glue has been used to help promote haemostasis.16 In the two largest series combined, device embolisation occurred in 4 (or 2.5%) of 159 patients.21 22 Procedural death is uncommon (∼0.5%) despite the complexity of the techniques.21 22 Procedural failure can result from prosthetic leaflet impingement or inability to cross the defects of the wire or guide catheter. Prosthetic leaflet impingement (∼5% of cases) can occur with any prosthesis but is more common in mechanical valves. Impingement can be minimised through the use of multiple, smaller devices, though the circular shape of these occluders and close proximity of the defect to the surgical annular ring can still be problematic. Prior to device release, particular care must be taken to ensure proper leaflet function for both 8
bioprosthetic and mechanical valves, with both imaging and haemodynamic assessments to be performed (ie, gradient calculation). Of note, release of tension on the system after device release can lead to repositioning of the occluder; thus, the possibility of leaflet impingement should be re-examined after final deployment. Clinical success and relief of symptoms have been shown to be related to the degree of residual regurgitation and are greater for patients with symptoms of heart failure than for those with haemolysis.24 Patients with haemolysis require a greater degree of closure, which can be technically challenging. Operator experience with the adoption of recently evolved techniques (eg, anchor wire, 3D imaging, transcatheter rails) is an important predictor of success with the therapy (figure 7).25 In a long-term evaluation of 126 patients who underwent percutaneous repair of paravalvular prosthetic regurgitation (age, 67 ±13 years; Society of Thoracic Surgeons Predicted Risk of Mortality, 6.7±5.4%), the 3-year survival was 64% (figure 8).24 Cardiac death occurred in 9.5%; the incidence of non-cardiac death was between 7.1% and 12.7%, owing to the significant morbidity of these patients. Notably, 72% of the survivors were free of severe symptoms or need for open cardiac surgery. Also of note, the New York Heart Association functional class improved only in those patients with residual regurgitation of mild or less. Sorajja P, et al. Heart 2015;0:1–9. doi:10.1136/heartjnl-2014-306270
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Review Contributors All authors contributed to writing and editing of the manuscript. Competing interests None. Provenance and peer review Commissioned; externally peer reviewed.
REFERENCES 1
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Figure 7 Adoption of imaging and catheter-based techniques with increasing operator experience in percutaneous repair of paravalvular prosthetic regurgitation. The graph shows the cumulative number of times a technique was used over an experience of 200 patients. Reproduced with permission from Sorajja et al.25
CONCLUSIONS Percutaneous repair of paravalvular prosthetic regurgitation is now an established therapy that can improve symptoms of heart failure and haemolysis, while avoiding the need for repeat sternotomy for appropriately selected patients. The procedure should be performed as part of a comprehensive, multidisciplinary valve programme with close collaboration between experienced operators and imaging specialists.
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Figure 8 Survival after percutaneous repair of paravalvular prosthetic regurgitation. (Top) Survival free of death or need for cardiac surgery according to residual regurgitation after paravalvular repair. (Bottom) Survival free of death or need for cardiac surgery according to the presence of haemolytic anaemia as an indication for the procedure. Reproduced with permission from Sorajja et al.24 Sorajja P, et al. Heart 2015;0:1–9. doi:10.1136/heartjnl-2014-306270
23 24 25
Davila-Roman VG, Waggoner AD, Kennard ED, 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. Rubino AS, Santarpino G, De Praetere H, et al. Early and intermediate outcome after aortic valve replacement with a sutureless bioprosthesis: results of a multicenter study. J Thorac Cardiovasc Surg 2014;148:865–71. Kodali SK, Williams MR, Smith CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012;366:1686–95. Hahn RT, Pibarot P, Stewart WJ, et al. Comparison of transcatheter and surgical aortic valve replacement in severe aortic stenosis: a longitudinal study of echocardiography parameters in cohort A of the PARTNER trial (placement of aortic transcatheter valves). J Am Coll Cardiol 2013;61:2514–21. Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-vavle replacement with a self-expanding prosthesis. N Engl J Med 2014;370:1790–8. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014;63:e57–185. Maganti M, Rao V, Armstrong S, et al. Redo valvular surgery in elderly patients. Ann Thorac Surg 2009;87:521–5. Luciani N, Nasso G, Anselmi A, et al. Repeat valvular operations: bench optimization of conventional surgery. Ann Thorac Surg 2006;81:1279–83. Altiok E, Frick M, Meyer CG, et al. Comparison of two- and three-dimensional transthoracic echocardiography to cardiac magnetic resonance imaging for assessment of paravalvular regurgitation after transcatheter aortic valve implantation. Am J Cardiol 2014;113:1859–66. Johri AM, Yared K, Durst R, et al. Three-dimensional echocardiography-guided repair of severe paravlavular regurgitation in a bioprosthetic and mechanical mitral valve. Eur J Echocardiogr 2009;10:572–5. Hamilton-Craig C, Boga T, Platts D, et al. The role of 3D transesophageal echocardiography during percutaneous closure of paravalvular mitral regurgitation. JACC Cardiovasc Imaging 2009;2:771–3. Ribeiro HB, Le Ven F, Larose E, et al. Cardiac magnetic resonance versus transthoracic echocardiography for the assessment and quantification of aortic regurgitation in patients undergoing transcatheter aortic valve implantation. Heart 2014;100:1924–32. Zoghbi WA, Enriquez-Sarano M, Foster E, et al. Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr 2003;16:777–802. Kappetein AP, Head SJ, Genereux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol 2012;60:1438–54. Zogbhi WA, Chambers JB, Dumesnil JG, et al. Recommmendations for evaluation of prosthetic valves with echocardiography and Doppler ultrasound. J Am Soc Echo 2009;22:975–1014. Jelnin V, Dudly Y, Einhorn BN, et al. Clinical experience with percutaneous left ventricular transapical access for interventions in structural heart defects a safe access and secure exit. JACC Cardiovasc Interv 2011;4:868–74. Momplaisir T, Matthews RV. Paravalvular mitral regurgitation treated with an amplatzer septal occlude device: a case report and review of the literature. J Invasive Cardiol 2007;19:E46–50. Kumar R, Jelnin V, Kliger C, et al. Percutaneous paravalvular leak closure. Cardiol Clin 2013;31:431–40. Spoon DB, Malouf JF, Spoon JN, et al. Mitral paravalvular leak: description and assessment of a novel anatomical method of localization. JACC Cardiovasc Imaging 2013;6:1212–14. Hourihan M, Perry SB, Mandell VS, et al. Transcatheter closure of valvular and perivalvular leaks. J Am Coll Cardiol 1992;20:1371–7. Ruiz CE, Jelnin V, Kronzon I, et al. Clinical outcomes in patients undergoing percutaneous closure of periprosthetic paravalvular leaks. J Am Coll Cardiol 2011;58:2210–17. Sorajja P, Cabalka AK, Hagler DJ, et al. Percutaneous repair of paravalvular prosthetic regurgitation: acute and 30-day outcomes in 115 patients. Circ Cardiovasc Interv 2011;4:314–21. Pitta SR, Cabalka AK, Rihal CS. Complications associated with left ventricular puncture. Catheter Cardiovasc Interv 2010;76:993–7. Sorajja P, Cabalka AK, Hagler DJ, et al. Long-term follow-up of percutaneous repair of paravalvular prosthetic regurgitation. J Am Coll Cardiol 2011;58:2218–24. Sorajja P, Cabalka AK, Hagler DJ, et al. The learning curve in percutaneous repair of paravalvular prosthetic regurgitation: an analysis of 200 cases. JACC Cardiovasc Interv 2014;7:521–9.
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Percutaneous repair of paravalvular prosthetic regurgitation: patient selection, techniques and outcomes Paul Sorajja, Richard Bae, John A Lesser and Wesley A Pedersen Heart published online February 12, 2015
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Heart Online First, published on February 12, 2015 as 10.1136/heartjnl-2014-306270 Review
Percutaneous repair of paravalvular prosthetic regurgitation: patient selection, techniques and outcomes Paul Sorajja, Richard Bae, John A Lesser, Wesley A Pedersen Center for Valve and Structural Heart Disease, Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA Correspondence to Dr Paul Sorajja, Center for Valve and Structural Heart Disease, Minneapolis Heart Institute, Abbott Northwestern Hospital, 920 East 28th ST, Minneapolis, MN 55407, USA; [email protected] Received 10 September 2014 Revised 9 January 2015 Accepted 21 January 2015
To cite: Sorajja P, Bae R, Lesser JA, et al. Heart Published Online First: [please include Day Month Year] doi:10.1136/heartjnl2014-306270
ABSTRACT Paravalvular prosthetic regurgitation is common, affecting 5–10% of surgical prostheses and 40–70% of transcatheter valves. While many patients may suffer no significant morbidity, paravalvular prosthetic regurgitation can lead to heart failure and haemolytic anaemia, and, in some studies, has been associated with impaired survival. Over the past several years, percutaneous repair of paravalvular prosthetic regurgitation has been demonstrated to be a highly efficacious therapy. When performed in experienced centres, procedural success with percutaneous repair occurs in 90% of patients. Due to the complex nature of the techniques, there is a significant learning curve with a high potential for prolonged procedures (∼2.5 h) and complications (∼5%), although death is rare (∼0.5%). Percutaneous repair of paravalvular prosthetic regurgitation requires a close collaboration between imaging specialists, surgeons and the interventional operators. Importantly, successful percutaneous repair obviates the need for open surgical correction, which can be high risk or prohibitive due to the need for reoperation in the setting of comorbidities. Herein, we discuss appropriate patient selection, the catheter-based techniques and outcomes of percutaneous repair for symptomatic paravalvular prosthetic regurgitation. Paravalvular regurgitation occurs in 5–10% of surgical prostheses and 40–70% of patients who undergo transcatheter valve replacement.1–5 Paravalvular prosthetic regurgitation can cause symptoms of heart failure or haemolytic anaemia, and, in some studies of transcatheter valve therapy, has been associated with impaired survival.3 While the traditional treatment for paravalvular prosthetic regurgitation has been open surgery, percutaneous approaches are now an established therapy for symptomatic patients.6 It is important to note that open surgical repair always necessitates reoperation, and that these patients frequently have severe morbidities that can significantly increase the surgical risk. Open surgery also may not be successful due to tissue characteristics that could have predisposed towards the original development of the paravalvular regurgitation. Thus, percutaneous therapy is inherently attractive as a relatively less invasive option for many patients with paravalvular regurgitation and now is frequently considered as primary therapy for eligible patients.
PATIENT EVALUATION AND SELECTION Patients who may be considered for percutaneous repair of paravalvular prosthetic regurgitation
should undergo a comprehensive, multidisciplinary evaluation within a centre where there is close collaboration between the clinical cardiologist, interventionalist, surgeon and imaging specialists.6 For all patients, the surgical risk with stratification tools and consultation should be considered. Repeat surgery will not be prohibitive in many patients, even though the reoperative risk will be increased relative to the initial surgery.7 8 When paravalvular prosthetic regurgitation is known or suspected, patients should be evaluated for both active endocarditis and haemolytic anaemia, even when there are not findings suspicious for these disorders. Active endocarditis is a contraindication to device occluder placement. The presence of haemolytic anaemia necessitates a very high degree of closure (ideally complete) and should be known when discussing therapeutic options during consent. Echocardiography is the primary imaging modality for the evaluation of paravalvular regurgitation. While 2D echocardiography is widely used as the initial screening tool, 3D studies with colour imaging are particularly useful in these patients. 3D echocardiography is less susceptible to interobserver variability for quantitation and provides detailed morphology that is used to plan and guide percutaneous repair.9–11 Notably, in some patients, acoustic shadowing can pose challenges for visualising paravalvular regurgitation (figure 1). Additional non-invasive imaging can be performed with cardiac CT or MRI, where the spatial resolution is not limited by imaging planes. Cardiac CT is highly accurate for determining the presence of paravalvular leaks, their size, orientation and surrounding calcification. These imaging studies also provide information regarding camera setup in the catheterisation laboratory and thus help facilitate the success of percutaneous closure (see ‘CT guidance’ section). Cardiac MRI has been demonstrated to have incremental utility over 2D echocardiography for quantitation of regurgitation, with less susceptibility to interobserver variability.9 12 Goals of the imaging examination are to determine the location and severity of the paravalvular regurgitation (including size and distance of the defect from the prosthesis annulus), the degree of ventricular compensation, and to exclude central valvular involvement and concomitant indications for open surgery. Of note, while echocardiography has been used to evaluate valvular regurgitation for decades, the echocardiographic criteria for quantification of paravalvular prosthetic regurgitation are less well studied.13–15 In patients with inconclusive non-invasive imaging studies, evaluation in the
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Review Figure 1 Echocardiographic imaging of paravalvular regurgitation. In some cases, acoustic shadowing can pose challenges in echocardiography for the detection of paravalvular regurgitation. (Top and middle) Transoesophageal echocardiography immediately after transcatheter implantation of a 26 mm Sapien valve shows mild central regurgitation (arrow), but no significant paravalvular regurgitation. Acoustic shadowing (top, arrow) of the anterior paravalvular area is present. (Bottom) Significant anterior paravalvular regurgitation is evident on apical long-axis view using transthoracic echocardiography (arrow). Ao, aorta; LA, left atrium; RA, right atrium.
cardiac catheterisation laboratory with a detailed haemodynamic assessment and angiography should be performed. For all patients, clinical judgement regarding severity of these defects and the likelihood of associated symptoms must be 2
exercised. It is important to note that defects that are not severe can still be haemodynamically significant and may benefit from therapy, but the decision to pursue such treatment should be individualised. In this regard, invasive haemodynamic studies Sorajja P, et al. Heart 2015;0:1–9. doi:10.1136/heartjnl-2014-306270
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Review with direct examination of ventricular filling pressures at rest and exercise may be helpful in the evaluation. In the most recent American College of Cardiology Foundation/American Heart Association guidelines on valvular heart disease, percutaneous repair of paravalvular prosthetic regurgitation is recommended for patients with severe symptoms or haemolysis, who are at high risk of surgery and who have suitable anatomic features (class IIa recommendation).6 In addition, it is our belief and that of many others that percutaneous repair may be considered for asymptomatic patients with evidence of attributable ventricular decompensation, and for patients who are not at high risk of open surgery if appropriate informed consent has been obtained in a shared decisionmaking process. Percutaneous repair should not be performed in centres without expertise in the procedure due to its considerable complexity, nor for patients with active endocarditis, a rocking prosthesis or significant valvular regurgitation.
PERCUTANEOUS REPAIR TECHNIQUES Device occluders Percutaneous repair of paravalvular regurgitation requires offlabel use of occluders. The most commonly used devices are the Amplatzer vascular plugs (AVP) (St. Jude Medical, Fridley, Minnesota, USA). These devices are made of self-expanding nitinol, deliverable through small calibre catheters (eg, 4 Fr), and have retention discs to help reduce the risk of embolisation after deployment. While the AVP-2 and AVP-4 devices are used in the USA, AVP-3 is available only in Europe. Other commonly used devices include the Amplatzer muscular ventricular septal defect and ductal occluders. Both of these latter occluders require relatively larger sheaths for delivery, but have been successfully employed in select cases. Of note, catheter accommodation for the various device occluders is not described well in the manufacturer’s labelling. Several guidelines, which have arisen from trial and error, are noteworthy: (1) a 6 Fr multipurpose guide catheter (Cordis, Bridgewater, New Jersey, USA) will accommodate a 12 mm AVP-2; (2) a 4 Fr diagnostic multipurpose catheter or Glidecath (Terumo Medical, Somerset, New Jersey, USA) will accommodate a 4 mm AVP-4; (3) a 4 Fr Cook Flexor Shuttle sheath (Cook Medical, Bloomington, Indiana, USA) will accommodate an 8 mm AVP-2; and (4) a 6 Fr Cook Flexor Shuttle will accommodate a 12 mm AVP-2 and a 0.03500 extra-stiff Amplatz wire simultaneously, or two 0.03200 extra-stiff Amplatz wires together.
Aortic paravalvular regurgitation For patients with aortic paravalvular regurgitation, the most common approach for percutaneous repair is retrograde via the femoral artery (figure 2). Selection of the echocardiographic modality is dependent on the location of the defect and the need to minimising acoustic shadowing of the regurgitant jet (transoesophageal for posterior defects; transthoracic for anterior ones). Intracardiac echocardiography of the aortic prosthesis from the right atrium also can be performed; manipulation of the catheter into the RV outflow tract may provide additional imaging details in these patients. The image intensifier should be positioned with no overlap between the defect and the aortic prosthesis. This positioning can be approximated (eg, left anterior oblique cranial for posterior defects; right anterior oblique caudal for anterior defects) or accurately determined from CT imaging. Without this positioning, it is difficult to determine whether the guidewire is being passed into the defect external to the prosthesis. For biplane Sorajja P, et al. Heart 2015;0:1–9. doi:10.1136/heartjnl-2014-306270
laboratories, the additional imaging intensifier is positioned en face to help with external placement of the wire, though this position can be difficult to attain with aortic prostheses. The defect is approached with a steerable coronary catheter (eg, 6 Fr Amplatz left or multipurpose catheter). An angled-tip, exchange-length (260 cm) hydrophilic wire (Glidewire, Terumo) is placed through the defect and often passed antegrade through the aortic valve in the event that snaring for a rail is required. Once the wire is across, a guide catheter is advanced into LV. Selection of the guide is dependent on (1) the size and number of device occluders that are needed, (2) difficulty encountered in passing the catheter across the defect and (3) need for an anchor wire. With the guide catheter in LV, the device occluder is extruded with retention discs positioned on the ventricular and aortic sides of the defect or, as frequently with AVP-4, wholly within the defect. The final assessment must include evaluation for prosthetic leaflet impingement and residual regurgitation. Angiography should also be considered to exclude arterial occlusion for patients requiring large device occluders and those with small aortic sinuses, low coronary height or defects located near the coronary ostia. Once the final assessment is satisfactory, the device occluders are released.
Mitral paravalvular regurgitation For patients with mitral paravalvular regurgitation, percutaneous repair usually is performed with general anaesthesia and transoesophageal echocardiography. The most commonly used approach is femoral venous access with transseptal puncture and antegrade cannulation of the defects from the left atrium. Alternatively, direct transapical puncture or a retrograde approach (via the femoral artery) with retrograde cannulation from LV also can be successful.16–18 For the antegrade approach, standard transseptal techniques with guidance from fluoroscopy and echocardiography are used to access the left atrium. In patients with posterior or medial mitral paravalvular defects, the relatively abrupt angulation to the defect can pose challenges for catheter engagement; a posterior or superior position for the puncture to gain height on the mitral valve can be beneficial in these cases. A steerable 8.5 Fr guide (Agilis catheter, St. Jude) is loaded with a telescoped catheter system, consisting of a 6 Fr 100 cm multipurpose guide and a 5 Fr 125 cm multipurpose diagnostic catheter (figure 3). The steerable guide can be small curved or medium curved; small-curved guides are particularly helpful for medial defects. This system is steered towards the defect, which is crossed with the Glidewire (Terumo). Fluoroscopy should demonstrate positioning of the steerable guide and guidewires external to the prosthesis ring. The two multipurpose catheters are placed sequentially into LV, followed by removal of the diagnostic catheter (figure 3). A device occluder can be passed through the 6 Fr guide, which can accommodate a 12 mm AVP-2. Alternatively, the guide can be exchanged over a 0.03200 extra-stiff Amplatz wire for a larger catheter (eg, 90 cm, 6–8 Fr Cook Flexor Shuttle) that enables either multiple device placements or anchor wiring. Similar to treatment of aortic defects, the distal retention disc of the occluder is extruded from the guide into LV, followed by straddling of the defect with the retention discs on both sides (figure 3). Once leaflet impingement has been excluded on both echocardiography and fluoroscopy, the device occluder(s) is released. Guidance from comprehensive transoesophageal echocardiography is essential to the success of the procedure. The echocardiographer and interventional cardiologist should communicate freely with regards to the location of the defect and its 3
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Review
Figure 2 Percutaneous repair of paravalvular aortic prosthetic regurgitation. Transoesophageal echocardiography demonstrates severe anterior aortic paravalvular regurgitation (arrowheads) involving a bi-leaflet mechanical prosthesis in a long-axis (A) and short-axis view (B). (C) An AL-1 diagnostic catheter is steered towards the defect, which is then crossed with a 260 cm, angle-tipped, extra-stiff Glidewire (arrowhead). (D) Over the Glidewire, an 8 Fr Cook Flexor Shuttle (arrowhead) is passed into LV, followed by placement of two 0.03200 extra-stiff Amplatz wires. (D) Over these two wires, two separate delivery sheaths (6 Fr Shuttle) are advanced into LV. The distal retention discs of two 10 mm Amplatzer vascular plug-2 are extruded into LV followed by apposition against the LV side (E) and deployed (F, arrowhead). The final view is chosen to demonstrate normal prosthetic leaflet motion. Postprocedural transoesophageal echocardiography in long-axis (G) and short-axis views (H) demonstrates mild residual regurgitation. Ao, aorta; LA, left atrium; RA, right atrium.
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Review Figure 3 Percutaneous repair of paravalvular mitral prosthetic regurgitation. An 8.5 Fr steerable sheath (Agilis catheter) is placed with transseptal puncture in the left atrium followed by advancement of a telescoped 100 cm 6 Fr multipurpose guide and 125 cm 5 Fr multipurpose diagnostic catheter. The sheath is used to steer the catheters and Glidewire towards anterolateral defect, which is then crossed (A, arrow). A 10 mm Amplatzer vascular plug-2 is extruded into LV (B, arrow), then positioned and deployed across the paravalvular defect (C) and deployed (D, arrow). For a medial defect, a retrograde approach is used, in which the wire is passed from LV into the left atrium, where it is snared with a 15 mm gooseneck (E, arrow). Over this rail, a delivery sheath is used to place two additional devices (F, arrows). Transoesophageal echocardiography performed shows the two paravalvular defects before device placement (G), during wiring of the defect (I) and after device placement (H and J). LA, left atrium.
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Review Figure 4 Transcatheter rail for aortic paravalvular regurgitation repair. The defect is wired retrograde with a Glidewire (A, arrow), which is then passed antegrade through the aortic prosthesis into the descending aorta. A 15 mm gooseneck snare is used to grasp the soft portion of the wire (B, arrow), which is then exteriorised. Tension on the exteriorised wire is used for support to place delivery catheters (C, arrow). Initial angiography suggests the possibility of occlusion of the left coronary artery by the Amplatzer vascular plug-2 (D), but subsequent angiography demonstrates sufficient distance to the coronary ostium (E). The occluder is then released (F).
cannulation. Some operators have proposed a clock-face method for this communication; this approach can be challenging due to the opposite viewpoints of fluoroscopy versus the traditional left atrial surgical view obtained by transoesophageal echocardiography. A different method relies on anatomically correct terminology (anterior vs posterior, lateral vs medial) and triangulation between the aortic valve (ie, anterior), left atrial appendage (ie, anterolateral) and atrial septum (ie, medial).19 For patients with mechanical valves, the location of the prosthetic commissures also can assist with orientation. In the retrograde approach from the femoral artery, a coronary catheter (eg, Judkins right, Amplatz left or right, or internal mammary) is placed into LV and oriented posterior towards the defect. This technique can be used when the transseptal approach is not successful, especially if the defect is located medially. The defect can be crossed with relatively softer wires, such as 0.01400 or 0.01800 coronary guidewires if the Glidewire proves to be too stiff for passage. In the transapical technique, defect cannulation and device placement is similar to the 6
antegrade approach. CT guidance with fusion imaging also has been demonstrated to be beneficial when performing the apical puncture and for steering towards the paravalvular defect (see section ’CT guidance’).
Transcatheter rails Placement of guide catheters can be challenging due to the serpiginous and often calcific nature of the paravalvular defects. In these instances, transcatheter rails can be used for greater support for catheter passage. Originally described for the treatment of congenital heart lesions, transcatheter rails are created by snaring of a guidewire that has been placed across the paravalvular defect followed by exteriorisation to provide the operator with both ends of the wire. The transcatheter rail can be placed left atrial–ventricular– aortic or left atrial–ventricular–apical for mitral paravalvular defects (figures 4 and 5). For aortic paravalvular defects, the rail can be easily placed aortic–ventricular–aortic, or, in select cases, aortic–ventricular–apical or left atrial–ventricular–aortic. Once Sorajja P, et al. Heart 2015;0:1–9. doi:10.1136/heartjnl-2014-306270
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Review the rail has been created, the operator can advance a guide catheter with support from an assistant who provides tension on both ends of the wire. When creating transcatheter rails, it is important to note that injury to surrounding structures can easily occur from guidewire tension. Harm can result from damage to the prosthetic or native leaflets, myocardial injury, severe bradycardia from atrioventricular node pressure and disruption of the mitral valve apparatus from chordal entanglement. Thus, transcatheter heart rails should only be performed with experienced operators and with careful haemodynamic monitoring and simultaneous echocardiography.
Multiple device placement and anchor wiring Paravalvular defects frequently are eccentric and in close proximity to the surgical sewing ring. As a result, successful closure can be challenging with the use of large occluders as device overhang can result in leaflet impingement of the valve, particularly with mechanical prostheses. Alternatively, multiple, smaller device occluders can be used through an anchor wire technique. In these instances, a large bore guide catheter (eg, a 6 Fr or larger Cook Flexor Shuttle) is placed into the ventricle once the defect is crossed with a hydrophilic guidewire. This guide catheter can accommodate multiple, extra-stiff guidewires that can then be used to place the delivery catheters either simultaneously (eg, two 6 Fr multipurpose guides) or sequentially over each wire. The anchor wire technique is also useful for maintaining a position across the paravalvular defect in the event that an occluder needs to be exchanged for different or multiple other devices. If anchor wiring is used, large bore sheaths are required to accommodate the multiple delivery catheters and
wires. The DrySeal sheath (W.L. Gore, Flagstaff, Arizona, USA), with its inflatable cuff, is uniquely suitable for maintaining haemostasis for this purpose.
CT guidance Cardiac CT easily identifies the site of paravalvular regurgitation and can assist with percutaneous closure. Imaging is performed with contrast, ECG-gating ( prospective or retrospective), a slice thickness of 0.5 or 0.6 mm for maximal spatial resolution and three or more reconstruction intervals to accurately identify the defect. Using information from echocardiography, the CT scan is reconstructed with views of exit point of the regurgitant jet, whose paravalvular continuity can then be examined (figure 6). Imaging with CT can help with sizing of the defect, its course, as well as provide information on surrounding calcification. For patients with bioprosthetic valves, CT imaging can also be used to examine the leaflet morphology to determine valvular contribution to regurgitation. This incremental utility may be of particular clinical benefit when there is significant acoustic shadowing on echocardiography. Fusion CT imaging can be used to facilitate percutaneous closure.18 In this technique, CT data are co-registered to cardiac structures (ie, chambers, valves, coronary arteries), enabling overlay onto the fluoroscopy screen. Fusion CT imaging is then used to guide access (transseptal antegrade vs retrograde apical), defect wiring and device placement.
CLINICAL OUTCOMES While the first report of percutaneous repair of paravalvular regurgitation was published in 1992, the vast majority of experience with the therapy has been in the past seven years.20
Figure 5 Transcatheter rail for mitral paravalvular regurgitation repair. (Top left) The defect is wired with a Glidewire (arrow) antegrade from the left atrium (LA). The wire can be snared in LV, but passage into the aorta is preferable in order to avoid potential entanglement of the snare with the mitral chords (top right). Over this rail, tension on both ends of the wire facilitates passage of an 8 Fr Cook Flexor Shuttle across the paravalvular defect (C, large arrow). The wire is left in place to facilitate multiple device placement (C, small arrow, and D).
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Review Figure 6 Guidance of paravalvular repair using CT. CT with contrast demonstrates a paravalvular defect in the posterior/superior aspect of Sapien valve (top left). The structures are aligned with a view of the defect immediately exterior and parallel to the valve prosthesis (top right). These angles are provided to a operator, who places the image intensifier in the same position and then wires the defect (middle left). A 12 mm Amplatzer vascular plug-2 is placed (middle right). (Bottom) Transoesophageal echocardiography demonstrates the paravalvular leak before (left, arrow) and after closure (right, arrow). Ao, aorta; LA, left atrium.
Procedural success, using a strict definition of reduction to mild regurgitation or less and no major adverse events, occurs in ∼80% of patients (∼90% for moderate residual regurgitation or less).21 22 Complications are relatively infrequent. In a series of 115 patients, the 30-day rate of adverse events was 1.7% for sudden or unexplained death, 2.6% for stroke, 0.9% for emergency surgery and 5.2% for periprocedural bleeding.22 Periprocedural bleeding can arise from cardiac perforation, particularly with apical puncture, as well as use of large vascular access sheaths and during bridging anticoagulation.23 Of note, closure of apical puncture sites with vascular plugs or surgical glue has been used to help promote haemostasis.16 In the two largest series combined, device embolisation occurred in 4 (or 2.5%) of 159 patients.21 22 Procedural death is uncommon (∼0.5%) despite the complexity of the techniques.21 22 Procedural failure can result from prosthetic leaflet impingement or inability to cross the defects of the wire or guide catheter. Prosthetic leaflet impingement (∼5% of cases) can occur with any prosthesis but is more common in mechanical valves. Impingement can be minimised through the use of multiple, smaller devices, though the circular shape of these occluders and close proximity of the defect to the surgical annular ring can still be problematic. Prior to device release, particular care must be taken to ensure proper leaflet function for both 8
bioprosthetic and mechanical valves, with both imaging and haemodynamic assessments to be performed (ie, gradient calculation). Of note, release of tension on the system after device release can lead to repositioning of the occluder; thus, the possibility of leaflet impingement should be re-examined after final deployment. Clinical success and relief of symptoms have been shown to be related to the degree of residual regurgitation and are greater for patients with symptoms of heart failure than for those with haemolysis.24 Patients with haemolysis require a greater degree of closure, which can be technically challenging. Operator experience with the adoption of recently evolved techniques (eg, anchor wire, 3D imaging, transcatheter rails) is an important predictor of success with the therapy (figure 7).25 In a long-term evaluation of 126 patients who underwent percutaneous repair of paravalvular prosthetic regurgitation (age, 67 ±13 years; Society of Thoracic Surgeons Predicted Risk of Mortality, 6.7±5.4%), the 3-year survival was 64% (figure 8).24 Cardiac death occurred in 9.5%; the incidence of non-cardiac death was between 7.1% and 12.7%, owing to the significant morbidity of these patients. Notably, 72% of the survivors were free of severe symptoms or need for open cardiac surgery. Also of note, the New York Heart Association functional class improved only in those patients with residual regurgitation of mild or less. Sorajja P, et al. Heart 2015;0:1–9. doi:10.1136/heartjnl-2014-306270
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Review Contributors All authors contributed to writing and editing of the manuscript. Competing interests None. Provenance and peer review Commissioned; externally peer reviewed.
REFERENCES 1
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Figure 7 Adoption of imaging and catheter-based techniques with increasing operator experience in percutaneous repair of paravalvular prosthetic regurgitation. The graph shows the cumulative number of times a technique was used over an experience of 200 patients. Reproduced with permission from Sorajja et al.25
CONCLUSIONS Percutaneous repair of paravalvular prosthetic regurgitation is now an established therapy that can improve symptoms of heart failure and haemolysis, while avoiding the need for repeat sternotomy for appropriately selected patients. The procedure should be performed as part of a comprehensive, multidisciplinary valve programme with close collaboration between experienced operators and imaging specialists.
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Figure 8 Survival after percutaneous repair of paravalvular prosthetic regurgitation. (Top) Survival free of death or need for cardiac surgery according to residual regurgitation after paravalvular repair. (Bottom) Survival free of death or need for cardiac surgery according to the presence of haemolytic anaemia as an indication for the procedure. Reproduced with permission from Sorajja et al.24 Sorajja P, et al. Heart 2015;0:1–9. doi:10.1136/heartjnl-2014-306270
23 24 25
Davila-Roman VG, Waggoner AD, Kennard ED, 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. Rubino AS, Santarpino G, De Praetere H, et al. Early and intermediate outcome after aortic valve replacement with a sutureless bioprosthesis: results of a multicenter study. J Thorac Cardiovasc Surg 2014;148:865–71. Kodali SK, Williams MR, Smith CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012;366:1686–95. Hahn RT, Pibarot P, Stewart WJ, et al. Comparison of transcatheter and surgical aortic valve replacement in severe aortic stenosis: a longitudinal study of echocardiography parameters in cohort A of the PARTNER trial (placement of aortic transcatheter valves). J Am Coll Cardiol 2013;61:2514–21. Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-vavle replacement with a self-expanding prosthesis. N Engl J Med 2014;370:1790–8. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014;63:e57–185. Maganti M, Rao V, Armstrong S, et al. Redo valvular surgery in elderly patients. Ann Thorac Surg 2009;87:521–5. Luciani N, Nasso G, Anselmi A, et al. Repeat valvular operations: bench optimization of conventional surgery. Ann Thorac Surg 2006;81:1279–83. Altiok E, Frick M, Meyer CG, et al. Comparison of two- and three-dimensional transthoracic echocardiography to cardiac magnetic resonance imaging for assessment of paravalvular regurgitation after transcatheter aortic valve implantation. Am J Cardiol 2014;113:1859–66. Johri AM, Yared K, Durst R, et al. Three-dimensional echocardiography-guided repair of severe paravlavular regurgitation in a bioprosthetic and mechanical mitral valve. Eur J Echocardiogr 2009;10:572–5. Hamilton-Craig C, Boga T, Platts D, et al. The role of 3D transesophageal echocardiography during percutaneous closure of paravalvular mitral regurgitation. JACC Cardiovasc Imaging 2009;2:771–3. Ribeiro HB, Le Ven F, Larose E, et al. Cardiac magnetic resonance versus transthoracic echocardiography for the assessment and quantification of aortic regurgitation in patients undergoing transcatheter aortic valve implantation. Heart 2014;100:1924–32. Zoghbi WA, Enriquez-Sarano M, Foster E, et al. Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr 2003;16:777–802. Kappetein AP, Head SJ, Genereux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol 2012;60:1438–54. Zogbhi WA, Chambers JB, Dumesnil JG, et al. Recommmendations for evaluation of prosthetic valves with echocardiography and Doppler ultrasound. J Am Soc Echo 2009;22:975–1014. Jelnin V, Dudly Y, Einhorn BN, et al. Clinical experience with percutaneous left ventricular transapical access for interventions in structural heart defects a safe access and secure exit. JACC Cardiovasc Interv 2011;4:868–74. Momplaisir T, Matthews RV. Paravalvular mitral regurgitation treated with an amplatzer septal occlude device: a case report and review of the literature. J Invasive Cardiol 2007;19:E46–50. Kumar R, Jelnin V, Kliger C, et al. Percutaneous paravalvular leak closure. Cardiol Clin 2013;31:431–40. Spoon DB, Malouf JF, Spoon JN, et al. Mitral paravalvular leak: description and assessment of a novel anatomical method of localization. JACC Cardiovasc Imaging 2013;6:1212–14. Hourihan M, Perry SB, Mandell VS, et al. Transcatheter closure of valvular and perivalvular leaks. J Am Coll Cardiol 1992;20:1371–7. Ruiz CE, Jelnin V, Kronzon I, et al. Clinical outcomes in patients undergoing percutaneous closure of periprosthetic paravalvular leaks. J Am Coll Cardiol 2011;58:2210–17. Sorajja P, Cabalka AK, Hagler DJ, et al. Percutaneous repair of paravalvular prosthetic regurgitation: acute and 30-day outcomes in 115 patients. Circ Cardiovasc Interv 2011;4:314–21. Pitta SR, Cabalka AK, Rihal CS. Complications associated with left ventricular puncture. Catheter Cardiovasc Interv 2010;76:993–7. Sorajja P, Cabalka AK, Hagler DJ, et al. Long-term follow-up of percutaneous repair of paravalvular prosthetic regurgitation. J Am Coll Cardiol 2011;58:2218–24. Sorajja P, Cabalka AK, Hagler DJ, et al. The learning curve in percutaneous repair of paravalvular prosthetic regurgitation: an analysis of 200 cases. JACC Cardiovasc Interv 2014;7:521–9.
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Percutaneous repair of paravalvular prosthetic regurgitation: patient selection, techniques and outcomes Paul Sorajja, Richard Bae, John A Lesser and Wesley A Pedersen Heart published online February 12, 2015
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