Abstract
Background
Severe mitral regurgitation (MR) after unsuccessful mitral transcatheter edge-to-edge repair (M-TEER) is relatively uncommon. Elderly comorbid patients may have limited options for definitive MR treatment after failed TEER.
Case Summary
A 72-year-old woman with dilated cardiomyopathy presented with symptomatic severe functional MR and underwent M-TEER. During the procedure, the patient developed hemodynamic instability due to posterior leaflet tear with torrential MR which could not be addressed by the TEER. The patient had refractory heart failure despite medical therapy and was not an operative candidate. Following heart team discussion, she underwent ELASTACLIP followed by transcatheter mitral valve replacement using SAPIEN M3. Her condition promptly stabilized, and she was discharged home with stable NYHA II symptoms and trace MR at follow-up.
Discussion
Failed M-TEER with significant residual MR carries a high risk of mortality with limited treatment options. Transcatheter mitral valve replacement with ELASTACLIP is a feasible and definitive solution in selected patients after failed M-TEER.
Take-Home Message
ELASTACLIP with transcatheter mitral valve replacement using SAPIEN M3 is a safe and effective option for failed M-TEER.
Key words: ELASTACLIP, mitral regurgitation, TEER, TMVR
Graphical Abstract
Mitral transcatheter edge-to-edge repair (M-TEER) with MitraClip (Abbott) is an established therapy with proven efficacy and safety for primary and secondary mitral regurgitation (MR).1 However, studies have shown that there is 3.5% risk of MitraClip failure due to loss of leaflet insertion, single leaflet detachment, or clip embolization. Although the complication rate is low, it is associated with high incidence of moderate-to-severe MR, heart failure (HF) hospitalization, and mortality.
Take-Home Messages
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Failed mitral TEER is not a rare complication. A heart team assessment into the mechanism and management strategies of TEER failure is essential for optimal patient management.
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Percutaneous transcatheter mitral valve replacement facilitated by ELASTACLIP provides safe and effective treatment for patients who are not candidates for a redo TEER or surgery.
There are limited treatment options for managing failed MitraClip including medical therapy, surgery, or redo TEER. Surgery is not a viable option for many patients who undergo TEER due to high surgical risk. Often, patient characteristics such as high residual gradient or poor leaflet tissue quality preclude redo TEER, and medical therapy may not adequately control symptoms.
The Electrosurgical Laceration and Stabilization of Clip (ELASTACLIP) technique, when combined with transcatheter mitral valve replacement (TMVR), has emerged as a less-invasive percutaneous reintervention option for failed TEER patients with prohibitive surgical risk.2 In this report, we describe a case of failed mitral TEER due to leaflet tear that was successfully treated with ELASTACLIP followed by TMVR with SAPIEN M3 (Edwards Lifesciences).
History of Presentation
A 72-year-old woman underwent M-TEER for symptomatic severe ventricular functional MR. The central MR jet was very broad, and the pathology was predominantly due to severe selective tethering of the posterior leaflet with anterior leaflet override and 3-mm coaptation gap (Figures 1 and 2). The initial procedural strategy was to implant 2 XTW clips at A2-P2.
Figure 1.
Transesophageal Echocardiography: Bicommissural View With X-Plane Showing Posterior Leaflet Tethering and Anterior Leaflet Override
Figure 2.
Transesophageal Echocardiography: Bicommissural View With X-Plane Showing Posteriorly Directed Jet
The TEER procedure was challenging due to a tethered posterior leaflet which made simultaneous leaflet grasping difficult. An attempt at independent grasping of the posterior leaflet resulted in a tear on the medial side of the valve, and further attempts to place a clip in this location were unsuccessful. Instead, an XTW clip was placed on the lateral side of A2-P2 (Figure 3). Further attempts to place a second XTW clip medial to the tear resulted in further damage of the posterior leaflet, and thus, the procedure was abandoned. The patient developed cardiogenic shock and was placed on inotropic and intra-aortic balloon pump (IABP) support. The patient had a complicated hospital course following the failed TEER procedure and was eventually discharged on maximally tolerated guideline-directed medical therapy. However, HF persisted, and she was readmitted to another hospital for 1 month with refractory HF and cardiorenal syndrome and was inotrope dependent. She was deemed a nonsurgical candidate and was referred to our program for consideration of mitral reintervention.
Figure 3.
Transesophageal Echocardiography: Bicommissural View With X-Plane and Color Showing Severe Mitral Regurgitation Jet on the Medial Aspect of A2/P2 Secondary to Posterior Leaflet Tear With an XTW Clip Attached to the Lateral Aspect of A2/P2
Past Medical History
The patient had a nonischemic dilated cardiomyopathy with primary prevention intracardiac defibrillator. Other comorbidities included atrial fibrillation, hypertension, and diabetes.
Differential Diagnosis
In this case, failed TEER was due to posterior leaflet tear. Other clinical considerations for causes of failed M-TEER include inability to grasp leaflets, loss of leaflet insertion, single-leaflet detachment, or clip embolization.
Investigations
Echocardiography demonstrated severe left ventricle dysfunction with an left ventricular ejection fraction of 30% with severe FMR and moderate RV dysfunction with mild TR. Baseline hemodynamic assessment showed left atrium pressure of 30 mm Hg with a V wave up to 48 mm Hg. Post procedure, the left atrium remained at 30 mm Hg with the V wave up to 50 mm Hg despite IABP support. Transesophageal echocardiography showed a well-seated XTW clip with an intact tissue bridge at the lateral aspect of A2-P2. There was evidence of flailing of the medial P2 segment resulting in malcoaptation and torrential MR. Subsequent gated cardiac CT indicated the mitral annulus had a perimeter-derived diameter of 45 mm with low risk of left ventricular outflow tract obstruction utilizing a SAPIEN M3 valve (Figure 4).
Figure 4.
Gated Computed Tomography Analysis of the Mitral Valve Showing an Annulus Diameter of 45.8 mm and Estimated neoLVOT Area of 430 mm2
Management
Multidisciplinary heart team discussion deemed the patient ineligible for surgery or redo TEER. The ELASTACLIP technique was selected based on CT and echocardiographic anatomy to restore a single-orifice mitral valve facilitating compassionate use of SAPIEN M3 implantation. We placed a 40-cc IABP via the left femoral artery for hemodynamic support. A 24-F Gore sheath was placed in the right femoral vein with preclosure. We advanced 2 Agilis sheaths through the previous septostomy 4.5 cm above the mitral annulus, placed on the medial and lateral sides of the clip. We planned to lacerate at the base of the anterior rather than posterior mitral valve leaflet as there is lower predicted risk of left ventricular outflow tract obstruction with this approach. Through each sheath, we placed a 6-F JR4 guide catheter to facilitate snaring of a 0.014-inch Astato XS20 guidewire that was focally denuded with Flying V configuration straddling the anterior mitral valve leaflet (AMVL) just proximal to the MitraClip insertion confirmed on transesophageal echocardiography and fluoroscopy (Figure 5). Using electrosurgery, we lacerated the base of the AMVL at the point of leaflet insertion such that the clip became liberated and attached only to the posterior mitral valve leaflet. This was well-tolerated with no acute change in hemodynamics. We then introduced the M3 delivery system through another transseptal puncture 3.5 cm above the mitral annulus. We encircled the mitral valve apparatus and mobile MitraClip with the dock under echo and fluoroscopy guidance, ensuring capture of the clip within the dock which was deployed with stable position (Figure 6). The SAPIEN M3 29-mm valve was then implanted within the dock under rapid pacing, leading to an excellent result with trace paravalvular MR and no complications (Figures 7 and 8, Video 1). The XTW clip remained attached to the posterior mitral valve leaflet and was jailed between the dock and SAPIEN M3 valve.
Figure 5.
Fluoroscopy and Transesophageal EchocardiographyShowing a Flying V Configuration Straddling the Anterior Mitral Valve Leaflet (AMVL) Just Proximal to MitraClip Insertion
Figure 6.
Fluoroscopy and Transesophageal Echocardiography Showing Encircling the Mitral Valve and MitraClip With the Dock
Figure 7.
Fluoroscopy Showing Deployed a SAPIEN M3 29-mm Valve Within the Dock With XTW Clip Jailed Between the Dock and Valve
Figure 8.
Transesophageal Echocardiography With Color Showing the SAPIEN M3 29-mm Valve With Trace Mitral Regurgitation
Outcome and Follow-Up
The patient's hemodynamics significantly improved, with reintroduction of guideline-directed medical therapy and subsequent discharge home. At 3-month follow-up, she reported dramatic improvement with no limiting symptoms or HF hospitalizations. Follow-up echocardiography showed trace MR and a mean mitral gradient of 5 mm Hg with improvement in right ventricular function.
Discussion
TEER is an established and mature therapy for treating both primary and secondary MR. TEER has increasingly been used for more complex anatomies with increasing operator experience. Although uncommon, TEER failure with significant residual MR is associated with adverse prognosis and may be difficult to treat. Here, we report a challenging case of failed TEER due to leaflet tear treated with ELASTACLIP followed by TMVR with SAPIEN M3.
TEER failure is not a rare phenomenon. In the FILM registry which included 4,294 MitraClip procedures, the incidence of M-TEER failure was 3.5% and was associated with higher rates of moderate to severe MR (43.9%) and death (29.3%).3 Most patients with failed TEER were managed conservatively with medical treatment (48.3%), with redo MitraClip in 34.7% and surgery in 17% of patients. Overall, a trend toward lower mortality was observed with an upfront redo MitraClip approach. However, 25% of redo TEER were unsuccessful, and 13.7% of these patients underwent urgent surgery. Some patients may not be even eligible for a redo TEER attempt because of a high residual gradient, small mitral valve area, unfavorable leaflet morphology, or other factors such as leaflet tear as seen in our case. Surgery is often not an option for patients whose M-TEER procedures were first done because they were deemed to have prohibitive operative risk.
ELASTACLIP combined with TMVR offers a less-invasive alternative that broadens the population eligible for reintervention. In this approach, transcatheter electrosurgery is used to intentionally detach the clip(s) from the anterior mitral leaflet, thereby restoring a single mitral orifice. ELASTACLIP was first described as a hybrid transseptal approach with transapical TMVR with Tendyne.2
SAPIEN M3 is an investigational percutaneous TMVR system that features a helical nitinol dock to encircle the mitral apparatus, creating a secure landing zone for the 29-mm SAPIEN M3 valve.4 The first case of ELASTACLIP with M3 was described by Inci et al, who aimed to shorten the time between ELASTACLIP and M3 deployment to minimize hemodynamic instability.5 They positioned the ELASTACLIP guidewire at the base of the AMVL, then encircled the mitral apparatus with the dock, lacerated the AMVL, followed by revealing the atrial turn for staged final dock deployment to ensure dock stability. Given the detached MitraClip moved freely between the atrium and ventricle inside the M3 dock during pacing, the M3 valve was deployed without pacing, with excellent final result. In our case, we chose to perform ELASTACLIP of the AMVL followed by dock implantation, which was well tolerated hemodynamically with simpler procedural steps.
In a recent report by Elison and colleagues,6 double ELASTACLIP was used to completely detach the clip from both leaflets before TMVR with M3. The ŌNŌ device (ŌNŌCOR Vascular) was used with a snare to remove the clip before TMVR. In this case, excision of the clip was deemed necessary before TMVR due to potential interference with the implantation of M3. Importantly, despite an increase in MR, the procedure was well tolerated with IABP support. The decision to perform single or double ELASTACLIP should be made on a case-by-case basis by the heart team based on the unique anatomy of each patient.
Conclusions
Failed M-TEER with leaflet tear is a management challenge. This case report demonstrates the feasibility and safety of ELASTACLIP and TMVR with SAPIEN M3 in selected high-risk patients, particularly when redo TEER is not possible.
Funding Support and Author Disclosures
Dr Fam is a consultant to Edwards Lifesciences, Abbott, Cardiovalve, Medtronic, Tricares, inQB8, and Jenscare. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Footnotes
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the Author Center.
Appendix
Visual Summary.
| Time Point | Event/Details |
|---|---|
| Day 0 | 72-year-old female admitted for TEER for severe functional MR |
| Day 1 | TEER complicated by a PMVL tear with torrential MR and cardiogenic shock requiring inotrope support and prolonged hospital stay |
| Day 18 | Discharge following TEER |
| Day 45 | Readmission to another hospital with refractory HF and cardiogenic shock requiring inotropes |
| Day 85 | ELASTACLIP followed by TMVR |
| Day 95 | Discharge following TMVR |
| Day 155 | Follow-up in clinic |
Appendix
Procedural Steps
References
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Supplementary Materials
Procedural Steps