Transcatheter Mitral Valve Repair for Wide Prolapse With Large Flail Facilitated by Ventricular Pacing

Abstract

Background

Transcatheter edge-to-edge repair (TEER) has been established as a safe and effective option for treating patients with severe symptomatic degenerative mitral regurgitation (MR) who are at high surgical risk.

Case Summary

This paper presents a case of a 74-year-old male patient with severe MR accompanied with wide prolapse and large flail, treated using an innovative TEER system, GeminiOne, and ventricular pacing. Postoperative echocardiography demonstrated a significant reduction in MR.

Discussion

This case report highlights the successful use of the GeminiOne TEER system to treat severe MR with complex anatomical challenge. The innovative use of ventricular pacing for leaflet capture can be valuable for managing complex mitral valve pathologies in high-risk patients.

Take-Home Message

This case highlights the safety and efficacy of the device and introduces a novel leaflet capture strategy.

Graphical Abstract

History of Presentation

A 74-year-old male patient was admitted due to exertional chest tightness and shortness of breath for more than 10 years, accompanied by poor appetite, fatigue, and gradually reduced exercise tolerance. Physical examination revealed heart rate 65 beats/min, blood pressure 125/63 mm Hg, a grade 2/6 systolic murmur at the cardiac apex, and bilateral lower limb edema. Laboratory tests showed N-terminal pro–B-type natriuretic peptide 656 pg/mL and cardiac troponin T 0.474 μg/L.

Learning Objectives

• •To understand the design of a new innovative device and its safety and efficacy in treatment.
• •To provide a novel method to capture complex prolapsed leaflet anatomy.

Past Medical History

The patient underwent percutaneous coronary stent implantations in 2016 and 2022 at our hospital for coronary atherosclerotic heart disease. Electrocardiogram indicated paroxysmal atrial fibrillation, managed with medication. He also had hyperlipidemia. Postoperative chest tightness and pain were relieved, but recent recurrence of exertional chest tightness and shortness of breath occurred.

Differential Diagnosis

Differential diagnoses for exertional chest tightness and shortness of breath include coronary artery disease, heart failure, arrhythmia, valvular heart disease, pulmonary hypertension, and respiratory disorders. In this case, the grade 2/6 systolic murmur at the cardiac apex strongly suggested possible mitral regurgitation (MR).

Investigations

Transthoracic echocardiography revealed thickened mitral leaflets with posterior leaflet prolapse and chordal rupture (posterior mitral valve leaflet [P3] zone, near the medial commissure), resulting in severe eccentric regurgitation (Figures 1A to 1C). The prolapse measured 14 mm in width, 9.4 mm in height, and a vena contracta width of 7.4 mm. Left ventricular ejection fraction was normal, with trace aortic regurgitation and mild tricuspid regurgitation. Pre-transcatheter edge-to-edge repair (TEER) echocardiographic parameters are detailed in Table 1. The patient was diagnosed with severe MR with posterior leaflet prolapse. With a Society of Thoracic Surgeons score of 7.83%, advanced age, comorbidities, and NYHA functional class III symptoms, a multidisciplinary team recommended TEER.

Figure 1.

Major Procedural Steps in This Case

(A and B) Three-dimensional transesophageal echocardiography shows severe mitral regurgitation (MR) jet from posterior mitral valve leaflet (P3) prolapse and tiny regurgitation jet. (C) Large flail in left ventricular outflow tract view. (D) Location and trajectory of the first clip. (E) Posterior leaflet flail into the left atrium with leaflet tip above the clip. The red arrow indicates the posterior leaflet flail into the left atrium with leaflet tip above the clip. (F) Pacing electrode in the right ventricle (RV). (G) Independent grasping with RV pacing at 180 beats/min. (H) P3 major MR eliminated and only residual regurgitation jet in the lateral. (I) Tiny residual jet after another clip implanted lateral to the first one.

Table 1.

Echocardiographic Parameters Before Transcatheter Edge-to-Edge Repair

Left ventricular end-diastolic volume, mL	160
Left ventricular end-systolic volume, mL	41
Left ventricular ejection fraction, %	74
Left atrial volume, mL	101
Mitral annulus anteroposterior diameter, mm	39
Right ventricular systolic pressure, mm Hg	25
Mitral valve orifice area, cm2	6.2
Carpentier classification type	Ⅰ+Ⅱ
MR grade	4+
Vena contracta width, mm	7.4
Prolapse height, mm	9.4
Prolapse width (P3 region), mm	14

MR = mitral regurgitation; P3 = posterior mitral valve leaflet.

Management

TEER was performed under general anesthesia. Guided by transesophageal echocardiography and fluoroscopy, transseptal puncture was performed, followed by placement of a super-stiff guidewire into the left upper pulmonary vein. A 22-F sheath was advanced into the left atrium. The TEER system was navigated to the mitral valve, aligned perpendicularly to the annulus. The clip was positioned subvalvularly, and ventricular pacing (180 beats/min) facilitated grasping of the previously beating posterior leaflet, followed by the anterior leaflet (approximately 43-second pacing, lowest systolic blood pressure 36 mm Hg). The first clip size is 0626 (6 mm width/13 mm length). Immediate postimplantation evaluation showed residual prolapse in the medial side of the clip near the commissure without regurgitation, but a functional regurgitation jet in zone 2. After the clip was successfully deployed, it was decided to place another clip of size 0426 (4 mm width/13 mm arm length) near the lateral side of the clip in zone 2, and the second clip was placed smoothly and the synchronous capture strategy was adopted (Figures 1D to 1I). Post-procedure, MR decreased from severe (4+) to mild (1+), with a mean transvalvular gradient of 2 mm Hg and the tissue bridge was stable from the view of 3-dimensional echocardiography. The patient improved symptomatically, with no complications, and was discharged after 5 days. Predischarge transthoracic echocardiography images confirmed device stability and stable MR grading.

Follow-Up

At 6-month follow-up, transthoracic echocardiography demonstrated persistent mild MR (1+). Left ventricular end-diastolic diameter decreased from 57 mm to 47 mm, end-diastolic volume from 160 mL to 102 mL, and left ventricular ejection fraction was 64% (within normal range, slightly reduced from baseline).

Discussion

MR is one of the most common valvular heart diseases worldwide, with its incidence and severity significantly increasing with age.¹ According to the China-DVD (China Elderly Valve Disease) study, MR accounts for the highest proportion (26.9%) among older patients with valvular heart disease in China.² The distinct pathophysiological mechanisms underlying MR necessitate tailored therapeutic strategies. Surgical repair/replacement remains the primary intervention for MR, whereas TEER serves as a safe alternative for patients with severe MR who are at high surgical risk or contraindicated for surgery.³

A novel TEER device in China, GeminiOne (Peijia Medical), differs from current existing devices such as MitraClip and PASCAL systems. Its unique features include an innovative sliding groove with a threaded mechanism enabling automatic locking/release at any angle. This design allows intraprocedural adjustment of grasping force to balance leaflet tension while ensuring easy deployment. Moreover, at 120° and 180° openings, the 0626 size of the clip achieves a capture width of 25 mm and 26 mm, respectively, superior to the MitraClip G4 system with the XTW clip. The system also enables independent leaflet grasping, providing flexibility for treating complex anatomy (Figure 2).

Figure 2.

Components and Features of the GeminiOne System

The 2 key components of the GeminiOne system include the steerable guide catheter, transcatheter edge-to-edge repair (TEER) delivery system. The GeminiOne 0626 has shorter clip length and wider clip arms when compared with the MitralClip XTW.

Data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry show that 85.9% of patients undergoing TEER have degenerative mitral regurgitation (DMR).⁴ In early TEER experiences for DMR, complex anatomical features—such as severe mitral annular or leaflet calcification, valve area <4 cm², bileaflet prolapse, and large flail gap/width—were considered unsuitable for TEER. However, advancements in device technology and techniques have continuously redefined anatomical limitations, making TEER a viable option for DMR patients with complex anatomies.^5,6 Wide prolapse and large flail lesions are among the most challenging pathologies in DMR. Wide prolapse involves excessive leaflet mobility, often with the leaflet root displacing toward the atrial side and complex motion trajectories, significantly increasing clip grasping difficulty. Similarly, large flail lesions indicate challenges due to fragile tissue. Current solutions include inducing cardiac arrest/bradycardia via rapid adenosine injection or rapid pacing, as well as the “anchor” technique. The former performs ventricular pacing to facilitate clip positioning, whereas the latter uses an initial clip to stabilize the flail segment, followed by additional clips to optimize grasping.7, 8, 9

In this case, the biggest challenge lies in the anatomy of the prolapsed leaflet, the posterior leaflet exhibits an anti-“Z” shape, and the prolapse height is high, so that when the clip is pulled to capture the posterior leaflet, the tip of the clip arm is always at the fold of the leaflet, and even if the unilateral capture strategy is adopted, that is, the anterior leaflet is captured first, and then the posterior leaflet, the higher part of the prolapse is still difficult to fall in the clip arm during diastole. If the clip is lifted too high, it can also cause the anterior leaflet to come out of the clip arm. After several repeated attempts, the decision was made to use ventricular pacing to capture the leaflets. As far as we know, this method is rarely used in cases domestically. Following 2 pacing attempts, leaflet motion trajectory and mobility were modified, enabling successful capture of the prolapsed posterior leaflet as described.

Last but not least, we also have some limitations in this case. Even though we successfully captured the leaflets with the first clip, there was still some residual prolapse on the medial of the clip that had not been resolved, due to the complex anatomy of the leaflet, and the narrow space on the medial of the clip was not enough to fit a small clip, so we quickly placed the second clip to stabilize the first clip and solve the functional regurgitation. According to domestic and international conferences, residual prolapse can affect the long-term reflux effect, but there is no relevant literature to support it, which is also our concern. However, according to the effect of the current 6-month follow-up, the regurgitation of MR is still maintained at mild (1+), and the enlarged left ventricle is smaller than before, which proves that the effect is significant.

Conclusions

This case validates the safety and efficacy of using a novel domestic transcatheter repair device for the treatment of severe MR with wide prolapse and flail, and also provides a novel strategy for the capture of leaflets with complex anatomy, which provides insight for similar treatments in the future.

Funding Support and Author Disclosures

The Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences (2021-I2M-1-065) was the source of funding. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.