Ann Thorac Surg 2005;80:2338-2342
© 2005 The Society of Thoracic Surgeons
New technology
Surgical Revision After Percutaneous Mitral Valve Repair With a Clip: Initial Multicenter Experience
Nicholas C. Dang, MD
a
,
Michael S. Aboodi
a
,
Taichi Sakaguchi, MD
a
,
Hal S. Wasserman, MD
b
,
1
,
Michael Argenziano, MD
a
,
Delos M. Cosgrove, MD
c
,
Todd K. Rosengart, MD
d
,
Ted Feldman, MD
e
,
Peter C. Block, MD
f
,
Mehmet C. Oz, MD
a
,
*
a Department of Surgery, Columbia University, College of Physicians and Surgeons, New York, New York
b Division of Cardiology, Columbia University, College of Physicians and Surgeons, New York, New York
c The Cleveland Clinic Foundation, Cleveland, Ohio
d Department of Cardiothoracic Surgery, Evanston Northwestern Healthcare, Evanston, Illinois
e Department of Cardiology, Evanston Northwestern Healthcare, Evanston, Illinois
f Department of Cardiology, Emory Healthcare, Atlanta, Georgia
Accepted for publication May 11, 2005.
* Address correspondence to Dr Oz, Division of Cardiothoracic Surgery, Department of Surgery, Columbia University, College of Physicians and Surgeons, 177 Fort Washington Ave, Milstein Hospital Building 7GN-435, New York, NY10032 (Email: mco2{at}columbia.edu).
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Abstract
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PURPOSE: Almost 50,000 mitral valve operations are performed annually in the United States, with an increasing number of repairs. Recently, a percutaneous mitral valve repair option that achieves edge-to-edge approximation with a clip has been described in patients with mitral regurgitation.
DESCRIPTION: We describe 6 patients from three centers with mitral regurgitation after percutaneous repair who underwent reintervention. During open surgical revision, the clips were uneventfully removed in all patients with no limitation in surgical options. Five patients underwent repair and 1 underwent replacement.
EVALUATION: After surgical revision, mitral regurgitation was significantly decreased, and all but 1 patient underwent uneventful recovery. One patient developed ilio-femoral deep venous thrombosis that was treated successfully with anticoagulation.
CONCLUSIONS: Preserving standard of care options is critical with any evolving technology in the event of initial treatment failure. Standard surgical options were preserved in all of the patients who underwent percutaneous mitral valve edge-to-edge repair. Furthermore, a thorough understanding of the clip design, in particular its unlocking mechanism, is essential and facilitates surgical clip removal.
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Technology
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Each year, almost 50,000 mitral valve (MV) operations are performed in the United States, with an increasing number of repairs. Common surgical techniques for MV repair include triangular or quadrangular resection, sliding annuloplasty, annuloplasty ring placement, and chordal transposition or the use of artificial chords. Edge-to-edge MV repair, originally described by Alfieri and colleagues [1], uses a simple technique of suturing the middle portion of the anterior leaflet to the opposite portion of the posterior leaflet, thereby creating a double orifice [2–4]. Over 1,000 patients in whom the edge-to-edge technique was used have been reported in peer-reviewed literature. A recent percutaneous extension of this approach achieves edge-to-edge MV repair using the Evalve system and MitraClip (Evalve, Inc, Menlo Park, CA). Under transesophageal echocardiographic and fluoroscopic guidance, the mitral leaflets are grasped and approximated with a polyester-covered clip to create edge-to-edge coaptation analogous to that achieved surgically (Fig 1). The system is designed to permit a traumatic release of the leaflets and repositioning of the clip, if necessary, for optimal reduction of mitral regurgitation (MR).
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Technique
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The potential advantages of this approach include a minimally invasive approach through percutaneous, femoral vein access in the cardiac catheterization suite; the ability to assess efficacy of repair with real-time echocardiography and ventriculography; absence of chest incisions; avoidance of cardiopulmonary bypass; considerably less postoperative pain than traditional MV surgery; anticipated shorter hospital length of stay; and a shorter recovery period. Large animal studies validated the feasibility of this approach [5, 6], and early clinical experience in humans has been favorable [7, 8]. However, despite the clear potential benefits of this procedure, as with any new technology, it is critical to preserve traditional treatment options in case the application of the novel approach is not successful or specific issues related to this new therapy arise. We describe 6 patients from three centers who underwent percutaneous clip deployment for MV repair and who thereafter required surgical intervention.
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Clinical Experience
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The patients described in this report were all enrolled in the Endovascular Valve Edge-to-Edge Repair Study (EVEREST I), a multicenter, Food and Drug Administration approved, prospective phase I clinical trial to evaluate the safety and feasibility of the Evalve percutaneous MitraClip system (Evalve, Inc). The trial protocol itself was approved by the respective institutional review boards. All patients gave informed consent for their participation. Twenty-seven patients were enrolled at six participating centers in the United States to undergo percutaneous mitral valve repair during the time period of this report. The largest single center experience was 9 patients and the smallest was 2 patients. Overall mean age was 68 years, 75% were male, and the cause of the MR was 93% degenerative and 7% functional (ischemic). All patients had moderate-severe (3+) or severe (4+) MR, either with symptoms, or (if asymptomatic) with ejection fractions < 60% or left ventricular end-systolic diameter > 45 mm. Three of the first 7 patients who enrolled did not receive a clip, whereas one or more clips were implanted in 24 patients. The 6 patients described in this article were culled from the group of 24 patients.
These 6 patients ultimately underwent surgical intervention for recurrent or persistent regurgitation and were managed at three medical centers. Patient characteristics are described in Table 1. Five patients had received one clip and in 1 patient, 2 clips were deployed. All echocardiograms were evaluated in a core laboratory, using American Society of Echocardiography guideline criteria for assessment of MR severity [9]. Core lab-reported MR grades before enrollment and throughout the patients' treatment course are outlined in Table 2. The mean time interval between percutaneous clip deployment and surgical revision was 55.5 ± 55.0 days (range, 1 to 133 days). The mechanisms underlying MR after percutaneous repair included four instances of inadvertent clip malposition at the time of implantation (including three instances of partial clip detachment from either the anterior or posterior leaflet), and two instances of insufficient MR reduction at the time of implantation (including one instance of a suboptimally placed clip that could not be re-positioned due to a malfunction of the delivery catheter).
In each patient, each clip was removed from the leaflets without difficulty. In all cases the clips themselves were affixed firmly to either one or both of the leaflets, and in most instances (all but the explants within 1 week) were covered with a thin layer of tissue. After clip removal, 5 patients underwent MV repair and 1 underwent MV replacement, which was deemed the optimal and intended surgical treatment option prior to percutaneous repair. The surgical procedures performed for each patient are outlined in Table 3. Echocardiograms were obtained before and after percutaneous repair, before surgical revision, and intraoperatively after surgical revision. Mitral regurgitation grades were designated as: 0 = none, 1+ = mild, 2+ = moderate, 3+ = moderate-severe, 4+ = severe.
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Results
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For the initial 27 patients enrolled in the EVEREST I trial, there were no procedural complications or instances of percutaneous repair causing leaflet damage. For the 6 patients who underwent surgical revision of percutaneous repair, mean postoperative follow-up was 337 ± 116 days (range, 233 to 536 days). All but 1 patient recovered well from the surgical procedure without any complications. One patient developed a right-sided ilio-femoral deep venous thrombosis on the same side as the catheter insertion site 3 days after the surgical intervention and 4 days after the percutaneous procedure. The patient was maintained on anticoagulation therapy. This patient also had a symptomatic pericardial effusion develop that required percutaneous pericardiocentesis. Of the 2 patients who had preoperative atrial fibrillation, 1 underwent a MAZE procedure and both underwent staple resection of the left atrial appendage. Both continued to have episodes of atrial fibrillation postoperatively and were maintained on oral anticoagulation therapy.
Mean MR grade was 3.7 ± 0.5, 1.8 ± 1.0, 3.2 ± 0.8, and 0.7 ± 0.8 before percutaneous repair, immediately after percutaneous repair, before surgical revision, and after surgical revision, respectively. All patients reported improved symptoms after their operation. There were no reoperations.
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Comment
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Alfieri and colleagues [1, 3] and others [4] have demonstrated that the edge-to-edge repair technique is a simple and effective surgical procedure for the treatment of MR due to complex mitral valve lesions. The technical simplicity of this procedure led to the development of a minimally invasive, percutaneous approach designed to accomplish the same repair. Percutaneous edge-to-edge repair does not require cardiopulmonary bypass and cardiac arrest, and because the clip is placed in a beating heart, assessment of the repair is possible while the heart remains under near-normal loading conditions [8].
In this report, percutaneous MV repair resulted in surgical revision for different reasons. A malfunctioning delivery system precluded proper placement of the clip in 1 patient. The clip was inadvertently malpositioned in 4 patients. Excellent reduction of MR was evident in the immediate post-procedure period in all 4 patients; however the malposition resulted in partial detachment of the clip from either the anterior or posterior leaflet in 3 patients and reintervention ultimately occurred in all 4. It is important to note that clip embolization did not occur in any patient. In the remaining patient, leaflet coaptation achieved by clip deployment, albeit properly positioned, was inadequate to achieve adequate MR reduction acutely. Mitral regurgitation reduction was substantial, but suboptimal. It was also believed that MR with atrial fibrillation after clip placement warranted open surgical revision. In retrospect, there was nothing inherently different with the valve anatomy and physiology in these 6 patients than in the 18 patients who did not require operative revision.
Importantly, all clips could be removed at surgery without major difficulty, and 5 valves were repaired and 1 was replaced, each with standard techniques. Surgical options were preserved for each patient, and operative management was not altered due to percutaneous intervention.
In these 6 patients, each clip remained well attached to either one or both leaflets. Depending on the interval between clip deployment and surgical revision, the clips were also secured to the valve leaflets in varying degrees through a thin layer of tissue. A basic understanding of the proper clip removal technique minimizes the likelihood of damage to the leaflets. Although none of the clips proved excessively difficult to remove, and removal did not cause leaflet damage, a variety of techniques were used for clip removal. The clip itself is comprised of arms joined together by a hinge and grippers (Fig 2). When deployed, the clip arms abut the ventricular side of the leaflets, while the grippers are seated on the opposing atrial side, effectively sandwiching each leaflet. A central lock assembly provides a means for unlocking the clip, thereby enabling the surgeon to open the clip arms.
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Fig 2. Side view of the MitraClip system (Evalve, Inc) (without polyester covering) and captured leaflet.
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In certain instances, one arm of the clip could be steadied with forceps while the underlying leaflet was carefully released from the clip using a second pair of forceps. If both arms were firmly secured to the leaflets, each leaflet was released sequentially. Another technique of clip removal took advantage of the two small loops of the lock assembly positioned at the fulcrum of the clip. Because these loops were readily visible from the atrial side, a 3-0 polypropylene suture was easily placed through the loops (Fig 3), and a malleable metal snare (tip of Frazier suction catheter) was applied to the fulcrum to release the locking mechanism. By simultaneously maintaining tension on the polypropylene suture and gently advancing the snare, we were able to open the clip and obtain access to the arms and grippers. Both leaflets could then be carefully separated from the clip (Fig 4).
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Fig 4. Forward pressure is applied from the atrial surface (red arrows) to open the clip arms to approximately 90°. If the clip is difficult to open, additional suture tension can be applied. After opening the clip arms, the grippers are lifted from the atrial surface, the leaflets are released, and the clip is removed.
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Once clip removal was achieved, the surgical MV procedures were routinely performed according to the surgeon's judgment. All MV repairs involved quadrangular resection of the middle segment of the posterior leaflet, followed by sliding annuloplasty and annuloplasty ring placement. Grossly, each of these diseased valves had redundancy of the posterior leaflet, with or without ruptured chordae. Tissue valve replacement was performed in a patient with excessive redundancy and severe prolapse and flail of both the anterior and posterior leaflets. Valve replacement was the initial intended operative strategy for this patient.
Percutaneous edge-to-edge MV repair may be a viable option for selected patients with MR. The reported efficacy of surgical edge-to-edge repair justifies the development and investigation of this approach through a minimally invasive means. Furthermore, although percutaneous clip deployment to date has not been combined with percutaneous ring or annular stiffening procedures, this approach may warrant investigation in the future. Indeed, some surgeons routinely place annuloplasty rings to support Alfieri edge-to-edge MV repair. Nevertheless, as with all evolving interventional technologies, it will be important to demonstrate that standard surgical options remain viable in the event of initial treatment failure, as we were able to confirm in each of these 6 patients. Moreover it remains important to identify patient groups who are likely to have durable results versus those who are better treated initially with conventional techniques. The progress of novel treatment strategies, such as this one, ultimately hinges on a thorough understanding of the mechanisms, potential benefits, and limitations of these therapies.
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Disclosures and Freedom of Investigation
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All funds used to perform the evaluation of the MitraClip system (Evalve, Inc) in the EVEREST I trial were provided and donated by Evalve, Inc and the participating investigative sites. The authors had full control of the design of the study, methods used, outcome measurements, analysis of data, and production of the written report.
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Footnotes
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Disclaimer The Society of Thoracic Surgeons, the Southern Thoracic Surgical Association, and The Annals of Thoracic Surgery neither endorse nor discourage use of the new technology described in this article.
1 Drs Wasserman, Cosgrove, Feldman, Block, and Oz disclose a financial relationship with Evalve, Inc. 
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References
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- Alfieri O, De Bonis M, Lapenna E, Maisano O, Torracca L, La Canna G. The edge-to-edge technique for Barlow's disease. Available at: http://www.fac.org.ar/tcvc/llave/c366/alfieri.PDF. Accessed August 11, 2004..
- Maisano F, Caldarola A, Blasio A, et al. Midterm results of edge-to-edge mitral valve repair without annuloplasty J Thorac Cardiovasc Surg 2003;126:1987-1997.[Abstract/Free Full Text]
- Alfieri O, Maisano F, De Bonis M, et al. The double-orifice technique in mitral valve repaira simple solution for complex problems. J Thorac Cardiovasc Surg 2001;122(4):674-681.[Abstract/Free Full Text]
- Maisano F, Torracca L, Oppizzi M, et al. The edge-to-edge techniquea simplified method to correct mitral insufficiency. Eur J Cardiothorac Surg 1998;13(3):240-245; discussion 245–6.[Abstract/Free Full Text]
- St. Goar FG, Fann JI, Komtebedde J, et al. Endovascular edge-to-edge mitral valve repairshort-term results in a porcine model. Circulation 2003;108(16):1990-1993.[Abstract/Free Full Text]
- Fann JI, St Goar FG, Komtebedde J, et al. Beating heart catheter-based edge-to-edge mitral valve procedure in a porcine modelefficacy and healing response. Circulation 2004;110:988-993.[Abstract/Free Full Text]
- Feldman T, Wasserman H, Herrmann HC, et al. Percutaneous edge-to-edge mitral valve repair using the Evalve clipcurrent status of the EVEREST I clinical trial. J Am Coll Cardiol 2004;94:S79.
- Zoghbi WA, Enriquez-Sarano M, Foster E, et al. American Society of EchocardiographyRecommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr 2003;16(7):777-802.[Medline]
- Block PC. Percutaneous mitral valve repair for mitral regurgitation J Interv Cardiol 2003;16(1):93-96.[Medline]
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