Tutorial

Percutaneous mitral valve repair with the edge-to-edge technique

Published: January 1, 2010
DOI: 10.1510/mmcts.2009.004002
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Percutaneous treatment of mitral regurgitation with the MitraClip system is an alternative to surgery in high-risk and inoperable patients. The device is designed to bond the opposing leaflets at the site of regurgitation, reproducing the results of the surgical Alfieri technique in a beating heart, catheter-based, approach. Here we describe the different steps of the procedure, which is performed under general anesthesia and guided by transesophageal echocardiography and fluoroscopy, using a sophisticated catheter-based system to deliver the clip at the desired target. We also summarize the currently available data, which support the application of this therapy in selected patients with either degenerative or functional mitral regurgitation.

Transcatheter mitral valve (MV) repair using the MitraClip (Abbott Laboratories, Abbott Park, IL) device is the most commonly used percutaneous procedure to treat mitral regurgitation (MR) to date. The device’s function is based on the surgical Alfieri technique concept: MR is corrected by suturing the leaflets at the site of regurgitation, regardless of the underlying mechanism of regurgitation . The first MitraClip procedure in a human was performed in 2003 and, at time of writing, more than 40,000 procedures have been performed since then. As with other transcatheter interventions, MitraClip therapy is ideally performed by a multidisciplinary team composed of surgeons, interventional and non-interventional cardiologists, anesthesiologists, and additional medical staff. Heart team discussion is essential to accurately select the patients, safely perform the procedure, and effectively follow up the patients after MitraClip therapy.

Once the heart team has confirmed the indication for mitral therapy, the anatomical eligibility for Mitraclip must be assessed by transthoracic (TTE) and transesophageal (TEE) echocardiography based on EVEREST criteria and the experience of the team . In patients undergoing MitraClip implantation to treat functional MR (FMR), it is advisable to exclude those with severe tethering of mitral leaflets and large coaptation gaps with pronounced displacement of the point of coaptation towards the apex. In addition, local calcification, in particular at the free leaflet margins, should be excluded to allow grasping of the leaflets. Stenotic valves and leaflet perforations are contraindications.

Treatment of more advanced MV deformations could be attempted by experienced teams, but with the risk of suboptimal MR reduction. In patients with degenerative MR (DMR), prolapsing or flail leaflets, ideally the gap between the free edges of the leaflets (flail gap) should be shorter than 10 mm and less than 5 mm wide to achieve adequate tissue grasping. Experienced surgeons, however, can address more advanced anatomies. In all patients we should be aware of clefts, which could be opened during asymmetrical grasping of the leaflets and thereby increase the severity of mitral regurgitation.  

We describe the step-by-step procedure of MitraClip therapy in a patient with DMR. 

The patient was an 81-year-old man with severe MR associated with a flail of posterior leaflet. He was admitted in New York Heart Association functional class III.  The EuroSCORE II–estimated risk of operative mortality was 2.8%. After multidisciplinary heart team discussion, and consideration of patient preference, the patient was assessed to be eligible for MitraClip therapy.

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    1- TEE assessment of mitral regurgitation (0:00)

    The regurgitation was caused by a P2 lesion, and flail width was 9 mm by TEE. Such anatomy can be treated simply and safety, since the first clip target is located in the chordal-free zone. Prior to the percutaneous MV treatment, the patient is prepared in a similar fashion as for an open surgical mitral valve procedure. 

    The implant is usually done under general anesthesia with TEE and fluoroscopy guidance. The femoral artery is punctured and a 5 French (F) sheath is introduced. A 5 F diagnostic pigtail catheter is then advanced into the left ventricle (LV) for continuous and reliable LV pressure monitoring. The contralateral femoral vein is then punctured at the groin. A 0.32 guidewire is advanced in the superior vena cava, and an 8.5 F, 63 cm long sheath (SL0TM; Abbott Laboratories, Abbott Park, IL), with dilator, is advanced over the guidewire. The Brockenbrough needle is inserted in the dilator and advanced until the tip of the needle is in the distal end of the dilator, but still inside it. The needle is oriented towards the left side, pointing down towards the floor.

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    2 - Transseptal puncture (0:07)

    The system with the Brockenbrough needle at its distal tip is slowly pulled back and turned counter-clockwise under fluoroscopic and TEE guidance. The catheter can be moved clockwise to achieve more posterior tenting. The location of the transseptal puncture is critical to providing a smooth procedure. Great care is therefore taken to obtain a perfect puncture under TEE guidance, employing a bicaval view (superior or inferior) and aortic valve plane short axis view (anterior or posterior). In general, transseptal puncture is placed superior, posterior and around 4 cm cranial of the mitral annulus plane in the fossa ovalis, but the etiology-specific location is often used. Adequate height for FMR is lower (<4 cm) to reach the target-tethered leaflet, and DMR is higher (>4 cm) to pull the target-flail leaflets once grasped.

    Before puncturing, a final check is obtained by a 4-chamber view, incorporating the puncture height marked by septal tenting to the free edge of the mitral valve at the site of regurgitation. When all the echo information suggest a correct position of the tenting, fluoroscopic confirmation of the position of the needle is taken in left anterior oblique (LAO) position, and finally the septum is punctured by advancing the Brockenbrough needle.

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    3 - Insertion of a steerable guide catheter (2:38)

    The transseptal sheath is advanced in the left atrium (LA) and the Brockenbrough needle and dilator are exchanged for 175 cm standard J-Tip wire and 260 cm Amplatz Super StiffTM  0.035 guidewire (Boston Scientific, Marlborough, MA). Both of them are gently advanced into the left pulmonary vein. Care should be taken to ensure that the stiff guidewire does not advance into the left atrial appendage (LAA) to avoid LAA rupture. Heparin is given at this time, and activated clotting time (ACT) is kept at 250-300 s and above throughout the procedure. The groin access is then preclosed with a figure-of-eight skin suture, and a 5 F pigtail catheter is advanced over the standard J-Tip wire across the septum into the LA for continuous and reliable pressure monitoring. Next, the steerable guide catheter (SGC) of the MitraClip system and its dilator are advanced over the stiff wire across the septum. The tip of the dilator is clearly visible on TEE (bicaval view) due to the presence of a coil. Once the SGC is completely passed across the septum, its handle is secured in the sterile stabilizer positioned on top of the previously placed, dedicated lift. The dilator and the guidewire are removed together, and the SGC is de-aired.

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    4 - Positioning the clip delivery system (2:57)

    The clip delivery system (CDS) is advanced inside the SGC and positioned in the LA for clip deployment under fluoroscopic guidance. The advancement of the tip of the CDS is carefully monitored in a left anterior oblique (LAO) view to avoid entry in a pulmonary vein. To steer towards the mitral valve, the medial knob of the delivery system is rotated clockwise. The CDS should then be aligned to the long axis of the heart, best confirmed by right anterior oblique (RAO) view. Once this position is reached, we can see the tip of CDS above the mitral leaflet by TEE. We then check the trajectory of the device. 

    The ideal trajectory should be parallel to the long axis of the heart and perpendicular to the mitral valve opening. If necessary, the trajectory can be modified by orienting the SGC in anterior or posterior position and by adjusting the medial knob of the CDS in medial or lateral position. The trajectory is checked on orthogonal two plane view of 2D TEE  (X-plane view); the intercommissural view (primary image), and the left ventricular outflow tract (LVOT) view, obtained on top of the clip.

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    5 - Positioning the clip (3:16)

    The clip is kept closed and the whole system is progressively steered towards the MV. Once the CDS is axially aligned perpendicularly above the line of coaptation of the MV, the clip arms are opened and oriented perpendicular to the line of coaptation and the grippers are elevated. In order to achieve the best position, the delivery system is capable of numerous adjustments, which can be made under 3D TEE and fluoroscopy guidance. The latter is helpful to continuously visualize the clip angle while grasping the leaflet, to correct any rotation. The ultrasound gain is usually reduced in order to better visualize the position of the clip relative to the MV.

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    6 - Grasping the leaflets (3:34)

    The CDS is advanced distally in the left ventricle (LV) across the MV using a TEE X-plane view. The clip should be equidistant to both leaflets. Usually, the clip splits the MR jet in color Doppler sonography. When all these requirements are met, the CDS is retracted slowly towards the LA. The leaflets are engaged and grippers are pushed down to lock the leaflets. The clip is slowly closed under echo guidance and the following echo measurements are made: MR jet modifications, symmetry of grasp, quantity of leaflet grasp/residual leaflet motion. If the MR jet is reduced by the clip and tissue grasping seems adequate, the clip can be released, otherwise the clip arms are everted and the clip repositioned. During all these phases, continuous hemodynamic measurement is helpful to determine the effect of the implant (e.g. change of LA v wave pressure and/or LV pressure). In case of doubt, evaluation of MR is done under drug and loading challenges (vasoconstrictors, sympathomimetics and bed tilting).

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    7 - Intraoperative assessment of MR, after clip placement (4:35)

    Not uncommonly (30–50%), a second clip must be implanted to further improve MR reduction, following the same procedure as described above . In this patient, there was moderate residual MR on the lateral side of first clip necessitating the use of a second clip. A second clip was implanted using a similar technique to the first, with fluoroscopy proving particularly helpful, because the first clip can be used for guiding. After that, no residual MR and no significant trans-MV diastolic pressure gradient is left. 

    Once the procedure is completed, the CDS is removed and the SGC is pulled back in the right atrium (RA). After that, the diameter and flow across the iatrogenic atrial septal defect are assessed and the pressure difference between LA and RA are measured.  If there is a significant shunt between RA and LA, closure of the defect should be considered to avoid a paradoxical embolism. Rarely, for example when there are large holes, a left-to-right shunt will need to be closed immediately after a MitraClip implantation.  The SGC is removed and the groin figure-of-eight suture is tied. 

    A final check with TEE is made to exclude pericardial effusion and volume overload in the superior vena cava, and to assess left and right ventricular systolic function. The TEE probe is then removed and controlled for blood bearing, as an indication for esophageal damage. The patient is either extubated at the table or transferred to the intensive care unit and is progressively weaned from general anesthesia and artificial ventilation. Short-term dual antiplatelet therapy is required after clip placement (clopidogrel 75mg daily for three months and aspirin 100 mg daily, indefinitely) unless the patient requires anticoagulant therapy for other reasons.

MitraClip therapy is approved for clinical use for both DMR and FMR in Europe. In the United States, Mitraclip is approved for DMR, while the ongoing COAPT trial (NCT01626079) is designed to strengthen the evidence for MitraClip therapy in FMR. COAPT is a randomized prospective multicenter trial comparing optimal medical therapy (OMT) and OMT with MitraClip in patients with FMR .

Since the first promising results from the EVEREST II trial were published , clinical experience with Mitraclip in patients with MR has grown considerably.  The randomized EVEREST II trial comparing MitraClip therapy to surgery revealed inferiority of the MitraClip to surgery for MR recurrence grade ≥3 and the need for MV surgery at 5 years. However, comparably low rates of surgery for MV dysfunction after either percutaneous or surgical therapy, for between 1- and 5-year follow-up, support the durability of MR reduction with both repair techniques

Beyond the 5-year follow-up period, little is known regarding the long-term outcome of Mitraclip therapy.

MitraClip therapy has been evolved to expand indications, manage anatomical difficulty, and to target lower surgical risk patients in the future.  This, therefore, should be a focus in future studies, as long-term durability cannot be deduced from surgical edge-to-edge therapy alone .

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We would like to thank the Heart Team and staff of hybrid room of University Heart Center Zürich, Zürich, Switzerland, for their assistance.

None declared.

This tutorial was originally published by EACTS with Oxford University Press and has been adapted to fit our new MMCTS templates.

Authors
Shingo Kuwata, MD, PhDa, Maurizio Taramasso, MDa, Evelyn Regar, MD, PhDa, Alberto Pozzoli, MDa, Michel Zuber, MDa, Philipp Haager, MDb, Felix C. Tanner, MDa; Fabian Nietlispach, MD, PhDa, and Francesco Maisano, MDa

Author Affiliations
aUniversity Heart Center, Zurich, Switzerland
bKantonsspital St. Gallen, St. Gallen, Switzerland

Corresponding Author
Francesco Maisano
University Heart Center, Zurich, Switzerland

Email: francesco.maisano@usz.ch

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