Simultaneous Double Clipping Delivery Guide Strategy for Treatment of Severe Coaptation Failure in Functional Mitral Regurgitation

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1 Heart, Lung and Circulation (2015) 24, /04/$ HOW-TO-DO-IT Simultaneous Double Clipping Delivery Guide Strategy for Treatment of Severe Coaptation Failure in Functional Mitral Regurgitation Ulrich Schaefer, MD *, Christian Frerker, MD, Felix Kreidel, MD Department of Cardiology, Asklepios Clinics Sankt Georg, Hamburg, Germany Received 20 March 2014; received in revised form 3 August 2014; accepted 3 September 2014; online published-ahead-of-print 28 September 2014 We report on a novel treatment strategy using two clip delivery systems (CDS) simultaneously, after double transseptal puncture, for treatment of severe functional mitral regurgitation. Both CDS were used to titrate for an optimal result in a patient with a severe coaptation gap of both mitral leaflets. The patient was successfully treated with two MitraClips. Thus, even a contraindication for MitraClip can be overcome with a more complex double guide intervention. Keywords MitraClip Severe mitral regurgitation Coaptation failure Transseptal puncture Simultaneous double clipping approach Haemodynamics Introduction There is intensive debate on whether patients should be treated with the MitraClip device only in accordance with the EVEREST criteria or not [1]. Nevertheless complex anatomies may preclude adherence to the instructions for use (IFU) to obtain procedural success. In this regard, the alternative strategy zipping by clipping has been proposed for patients with severe functional mitral regurgitation and little coaptation [2]. With this approach, several clips are sequentially implanted, with the first being placed either in the medial or lateral commissure followed by a second or third clip. Having closed the mitral orifice at one side, an improved coaptation of the leaflets within the centre of the mitral valve may facilitate targeting the main area of mitral regurgitation. The major limitation of that approach is the risk of valvular distortion, leading to persistent mitral regurgitation with jet fragmentation after sequential clip deployment. Thus, the simultaneous use of a two-clip delivery system, i.e. double CDS approach (dcds) might be an appealing concept, since device optimisation can be obtained at all times until the clips are completely deployed. Moreover, this approach gives the operator the possibility to close a severe coaptation gap with sequential closing and opening manoeuvers of both clips. That means, having performed a successful grasp with the first clip (remaining attached to the CDS), the second clip can be placed more easily next to the first clip due to an improved coaptation. Now the first clip can be reopened and a better leaflet insertion can be obtained ( mitral titration ). This manoeuver can be repeated several times until a sufficient result is achieved. Case report: To prove this concept, a patient with severe functional mitral regurgitation (FMR) was chosen for treatment with the dcds-approach at our institution. PMH: A 77 year-old male patient was referred for a Mitra- Clip procedure to our centre. The patient suffered from severe shortness of breath on slight physical exertion (NYHA 3) and he complained about dizziness. Routine transoesophageal examination discovered severe functional mitral regurgitation (see Figure 1), but the anatomy was judged to be too complex for a standard MitraClip procedure. Laboratory testing *Corresponding author at: University Heart Center Eppendorf, Department of Cardiology, Martinistrasse 52, Hamburg, Germany. Tel.: , u.schaefer@uke.de 2014 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier Inc. All rights reserved.

2 Simultaneous double MitraClip implantation 99 Figure 1 a and b) Transoesophageal echocardiography displaying significant mitral regurgitation before mitral clipping (left panel). After implantation of two MitraClips mitral regurgitation is significantly reduced (right panel). showed normal troponin levels and a markedly elevated Nt-proBNP. Coronary angiography showed significant coronary three-vessel disease with patent coronary arterial bypass grafts (CABG) to all three coronaries. Due to several comorbidities (COPD, severe pulmonary hypertension, peripheral artery disease, a reduced LVEF of 38%) resulting in a high surgical risk (logeuroscore 39.8%; STS risk of mortality 8.7%) a MitraClip approach was chosen within the HEART team as the preferred treatment option. The patient was scheduled for a MitraClip procedure with the option to use the dcdsstrategy and gave written informed consent for this novel approach. Due to a significant coaptation failure (see Figures 2a and 2b; complete P2 and A2 segment with a coaptation gap of 11 mm, coaptation depth 5 mm) the first puncture was performed in the posterior aspect of the fossa ovale, with an estimated distance of 4.2 cm above the mitral coaptation gap. After administration of IU heparin, the first CDS was introduced. The first clip was oriented using 3D TEE to the lateral border of the A2/P2 segment, with precise perpendicularity to the line of coaptation. After two grasps we were able to obtain some insertion of both leaflets inside both clip arms and the clip was almost completely closed. Due to persistent mitral regurgitation we decided to continue with the dcdsstrategy. The second transseptal puncture was performed via a left femoral vein access, slightly anterior to the first puncture site (4.3 cm above the coaptation gap). Subsequently, the second CDS was advanced across the septum, while the first CDS was kept connected to the first MitraClip. Unfortunately, with this anterior puncture we were not able to steer the second CDS to the medial border of the A2/P2 segment of the mitral valve, since the first guide was clearly obstructing the path to that particular mitral location (even after steering the second CDS across the first CDS to the posterior site). Thus, we decided to reopen the first clip and to relocate it to the medial site of the mitral valve. After a successful grasp with the first CDS, we observed some reduction of mitral regurgitation (but far from being acceptable). Following that, the second CDS was placed into the lateral aspect of the A2/P2 segment and with a single grasp, we found a significant reduction of mitral regurgitation (grade 1+). Despite the fact that the 3D-TEE confirmed a broad tissue bridge on both sides of the A2 and P2 segment (see figure 2c), with an insignificant mean transmitral gradient of 3 mmhg (CW-doppler), we decided to reopen the medial MitraClip to obtain a better result. After re-grasping at that particular site, the mitral regurgitation was further reduced (see figure 1b, 3, 4) and both Clips were sequentially deployed. While both guides remained in the left atrium, right heart catheterisation revealed a satisfactory increase in cardiac output (CO before: 3.3 L/min; CO after dcds: 6.1 L/min) and a dramatic decrease of the left atrial pressure (v-wave before: 48 mmhg; 1 Clip: 29 mmhg; after dcds: 13 mmhg, see figure 4). The improved haemodynamics was substantiated by a decrease in pulmonary arterial pressure (systolic PAP before: 52 mmhg; systolic PAP after dcsd: 45 mmhg) as well as pulmonary capillary wedge pressure (PCWP before: 25 mmhg; PCWP after dcsd: 19 mmhg). Thereafter, both guides were carefully removed from the left atrium and a significant left-to-right shunt was ruled out (Qp/Qs = 1.13). Both peripheral 24F puncture sites were closed with a Perclose1 (Abbott Vascular) and the patient was quickly extubated and transferred to the peripheral ward. The following day, the patient reported an immediate improvement (NYHA class II) and he was discharged at day 3 after the procedure on clopidogrel (75 mg) and aspirin (100 mg) for four weeks. At 30 days follow-up, the patient presented himself in a persistent improved clinical state (NYHA class II) and echocardiography revealed a mild residual MR with a continuously small transmitral gradient (3 mmhg). Discussion This is the first report demonstrating the feasibility of a more complex dcds- based strategy, to treat a patient with severe

3 100 U. Schaefer et al. Figure 2 a, 2b and 2c) 3D-transoesophageal echocardiography with surgical view during systole (left panel) and diastole (middle panel) displaying a significant central coaptation gap. 3D-transoesophageal echocardiography displaying the surgical view with a broad tissue bridge in the A2/P2 segment after placement of two MitraClips (right panel).

4 Simultaneous double MitraClip implantation 101 Figure 3 a and 3b) Fluoroscopy demonstrating the double CDS approach with two CDS placed simultaneously across the interatrial septum. The medial located CDS is operated during re-grasping for mitral titration while the lateral MitraClip is closed but still connected to the CDS (left panel). Left ventricular angiogram with no evidence of mitral regurgitation while both MitraClips are closed but still connected to the CDS (right panel). Figure 4 Invasive measurement of LA and LV pressures before, after placement of the 1st Clip, and after deployment of the 2nd MitraClip. Note: the significant decrease of the v-wave while the LV pressure is increasing. MR due to a large coaptation gap. In general, there is a considerable number of patients with functional MR who present with extensive annulus dilatation and minimal vertical leaflet coaptation, that either potentially preclude them from MitraClip therapy for anatomical reasons or may warrant a more complex implantation strategy [2,3]. Within the EVEREST II randomised trial and high-risk study, a more severe mitral regurgitation has been shown to be a predictor for the necessity of two MitraClips comprising the standard technique with a single CDS (scds) approach [4]. In this study 42% of the patients had to be treated with two Mitra- Clips. Similar data was derived from the ACCESS EU registry, the largest non-randomised prospective registry, possibly displaying the best real world situation, since more than two thirds of the patients were treated for FMR [5,6]. Moreover, a recent paper demonstrated that a more severe mitral regurgitation is more likely to need treatment with two MitraClips. The authors calculated a vena contracta width of 7.5 mm to be predictive for the need of a second clip [7]. Thus, the use of multiple MitraClips is not a rare phenomenon. With the scds-technique, suboptimal grasping might lead to early or even acute partial clip detachment, necessitating additional MitraClips or even conversion to open heart surgery. In addition, the sequential implantation of a second MitraClip might also induce a partial clip detachment of the first deployed MitraClip, due to non-physiologic forces

5 102 U. Schaefer et al. during CDS manipulations/steering (e.g. after being entangled within the subvalvular apparatus). With the dcds-approach reopening of a partially detached MitraClip is possible at any time, giving additional safety until the decision is made to deploy these clips. In addition, one clip or even both clips can be removed if a non-satisfactory result has been achieved (e.g. high residual grade of mitral regurgitation or significant transmitral gradient). In addition, after encountering a satisfactory result with a single clip (e.g. after mitral titration), the second clip can be removed safely. Thus, having both CDS in place a final decision making process gives the operator the chance to completely abandon the patient from MitraClip therapy (leaving a better window open for conventional valve surgery) or to improve the initially obtained result due to a titration strategy in the setting of minimal or no coaptation. In the present case, we actually had to reopen the first MitraClip (lateral) due to interference between both CDSs, preventing a perfect alignment of the second CDS (medial). We clearly learned that a more anterior transseptal puncture of the second CDS does allow the best method of reaching the lateral site of the mitral valve. Thus, the posterior transseptally introduced CDS should always be oriented to the medial site of the mitral valve. This approach preserves the largest amount of steering possibilities. In addition, with the dcds-technique, we had the opportunity to reopen the first MitraClip (initially used as a coaptation facilitator for the second Mitra- Clip) after we found it to be suboptimal in terms of mitral regurgitation reduction. Indeed, after regrasping the first MitraClip (now the second MitraClip was facilitating the coaptation) we found an impressive reduction in mitral regurgitation (graded as trace). Limitations: This is just a single case presentation describing the potential benefits of the dcds-strategy. Nevertheless, the dcds-approach adds a significant amount of complexity to the standard approach, precluding non-experienced operators from that technique. In addition, two 24F holes are created within the interatrial septum giving the risk of significant shunting (which needs to be ruled out). Last but not least, a more comprehensive study with a larger study cohort would be needed to understand the benefits and risks with this dcds-approach. Conclusion The edge-to-edge technique with the dcds-approach seems to be an interesting strategy in complex MR patients. Due to the lower invasiveness of the MitraClip procedure as opposed to surgical mitral valve repair, we used the dcds-strategy in a patient with high surgical risk. In fact, with this novel technique we could demonstrate for the first time that the mitral valve can be titrated sequentially to obtain the best achievable result. Further efficacy testing of this specific technique might be of interest in the future. References [1] Feldman T, Foster E, Glower DD, Kar S, Rinaldi MJ, Fail PS, et al. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med 2011;364: [2] Kische S, Nienaber C, Ince H. Use of four MitraClip devices in a patient with ischemic cardiomyopathy and mitral regurgitation: zipping by clipping. Catheter Cardiovasc Interv 2012;80: [3] Paranskaya L, Kische S, Bozdag-Turan I, Nienaber C, Ince H. Mitral valve with three orifices after percutaneous repair with the MitraClip system: the triple-orifice technique. Clin Res Cardiol 2012;101: [4] Armstrong EJ, Rogers JH, Swan CH, Upadhyaya D, Viloria E, McCulloch C, et al. Echocardiographic predictors of single versus dual MitraClip device implantation and long-term reduction of mitral regurgitation after percutaneous repair. Catheter Cardiovasc Interv 2013;82(4): [5] Ussia GP, Cammalleri V, Scandura S, Imme S, Pistritto AM, Ministeri M, et al. Update on percutaneous mitral valve therapy: clinical results and real life experience. Minerva Cardioangiol 2012;60: [6] Maisano F, Franzen O, Baldus S, Schafer U, Hausleiter J, Butter C, et al. Percutaneous Mitral Valve Interventions in the Real World: Early and One Year Results From the ACCESS-EU, a Prospective, Multicenter, Non- Randomized Post-Approval Study of the MitraClip(R) Therapy in Europe. J Am Coll Cardiol 2013;62(12): [7] Alegria-Barrero E, Chan PH, Foin N, Syrseloudis D, Tavazzi G, Price S, et al. Concept of the central clip: when to use one or two MitraClips(R). EuroIntervention 2014;10: