Cardioband removal for secondary mitral valve regurgitation: pitfall and surgical technique

Abstract

Mitral regurgitation is a challenging condition, especially in patients at high risk for open heart surgery. Nowadays, trans-catheter procedures for treatment of valvular disorders represent a valid alternative to traditional surgical techniques. These include not only the trans-catheter valve implants but also other percutaneous devices used to repair native valves, notably mitral valve. However, in case of failure, mis-placement, or unsatisfactory results of percutaneous devices, explant and correction of the valvular disease may be required. In such scenarios, only traditional surgery techniques can be efficacious. A case of Cardioband System (Edwards Lifescience, Irvine, CA, USA) surgical explant and valve replacement for persisting mitral valve regurgitation is reported. The technical details and pitfalls of the surgical removal procedure are discussed.

Introduction

In patients at high risk for open surgery, the mitral regurgitation (MR) remains a challenging condition to be treated. That’s why nowadays percutaneous procedures are being increasingly used in every day clinical practice for frail patients who could not be referred for traditional operation.

Among these minimally invasive devices, catheter-based edge-to-edge mitral valve repair (i.e. Mitraclip device; Abott Vascular, Santa Rosa, CA, USA) is widely performed. However, this technique is not able to solve regurgitation from the leaflet that is normally fixed by annuloplasty during a traditional open-chest surgical approach.

The Cardioband System (Edwards Lifescience, Irvine, CA, USA) has been proposed more recently for these patients. This is a percutaneous device designed to reproduce the traditional surgical technique, mimicking a direct annuloplasty. In fact, Cardioband improves the valvular coaptation, shrinking the annular diameter overall, thereby reducing the severity of regurgitation. Despite its usefulness in selected situations, some series reported persistency of moderate to severe MR after implantation in up to 45.4% of patients at 6-month follow-up, in case of difficult anatomic presentation. [1] In such situations, surgical explant of Cardioband, in addition to valvuloplasty/valve replacement, must be considered.

In the present article, we report a case of surgical Cardioband explant followed by mitral valve replacement for persisting MR. The potential pitfalls and the specificity of different steps of the surgical removal procedure are also discussed.

Case report

A 60-year-old patient affected with permanent atrial fibrillation, end-stage renal disease, and severe MR due to dilated cardiomyopathy was treated in July 2013 by Cardioband implantation by a trans-femoral approach, under fluoroscopy and transesophageal echocardiography guidance. Cardioband implantation was scheduled by the cardiology team, taking into account the presence of severe and persistent dyspnea, non-regressive after adjusted and optimized medical treatment.

Postoperative echocardiography showed the persistency of a mild MR.

In August 2017, he was admitted at the Emergency Department of our Institution complaining of dyspnea New York Heart Association functional class (NYHA) III and peripheral edema related to congestive heart failure (CHF).

Transthoracic echocardiography showed severe MR due to bi-valvular restriction (MR-PISA (Proximal Isovelocity Surface Area) effective regurgitant orifice area 0.30 cm2, MR volume 30 ml, left ventricular ejection fraction 45%). The mitral annulus was severely dilated (42 mm in maximal diameter) and the Cardioband was completely disconnected at the level of the posterior commissure and anchors displaced (Fig. 1).

Fig. 1.

Two- dimensional (a) and three-dimensional (b) echocardiography images showing the dehiscence of the Cardioband and the severe mitral regurgitation (white arrow)

Due to clinical status and imaging results, after a multidisciplinary team evaluation, the patient was scheduled for surgical treatment. The procedure was performed under general anesthesia and by median sternotomy. After the establishment of the cardiopulmonary bypass, a left trans-atrial approach was used to explore the mitral valve. The Cardioband was seen: it was covered by the new endothelium and completely disconnected at the level of posterior commissure (Fig. 2).

Fig. 2.

Surgical view after access to the mitral valve showing the dehiscent Cardioband at posterior commissure (black arrow) with the disengaged anchors and the laceration of the annulus

The Cardioband consists in a polyester sleeve that is percutaneously fixed over the annulus by the means of 12–17 stainless steel 6-mm-long anchors. The anchors penetrate deeply in the annulus to fasten the sleeve in place. In order to preserve the annulus wall as much as possible, its removal should be realized carefully and gently. We decided thus to start the excision of the device by cutting the apparent anchor one by one by means of a Linston cutter beginning from the posterior commissure and proceeding clockwise until we reached the anterior commissure. A Bengolea clamp was then used to gently unscrewed anchors from the native annulus (Fig. 3).

Fig. 3.

The different steps of surgical procedure. a After median sternotomy and cardiopulmonary bypass establishment, a left trans-atrial approach was used. b The cardioband was disconnected at the level of posterior commissure and one anchor was visible outside from the annulus. c The device excision was begun starting from the posterior commissure and proceeding clockwise. The anchors were cut one by one by the means of a Linston cutter. d A Bengolea clamp was used to gently unscrewed anchors from the native annulus

Even though the removal was minutely and gently performed, the posterior mitral leaflets and annulus got severely damaged. We were thus forced to perform valvular replacement, using Magna Ease Size 29 Valve (Edwards Lifescience, Irvine, CA, USA) and braided 2–0 sutures with pledgets to consolidate the annulus.

Postoperatively, the patient recovered well. He is still alive and in good clinical condition at 2-year follow-up.

Discussion

The Cardioband system is a percutaneous device designed to treat high-risk patients affected with MR, who cannot be referred for open mitral surgery. Implantation of the Cardioband is performed under echocardiographic and fluoroscopic guidance by a trans-femoral or a trans-septal approach. It is designed to achieve a posterior annuloplasty through the implantation of a prosthetic band by a suture-less technique on the beating heart. [2] Specifically, it consists of a Dacron band that is fastened on the posterior annulus, from the anterolateral to posteromedial commissures, by means of stainless steel anchors, resulting in significant reduction in annular diameter and thus of functional MR [3, 4]. However, being in early experience, in difficult anatomic presentations, moderate to severe functional MR could persist after Cardioband implantation (up to 45.4% of patients at 6-month follow-up) [1] and surgical removal and traditional valvuloplasty/replacement may be required.

In this paper, we report a patient who underwent surgical removal of a partially disconnected Cardioband. Only two cases have been yet published in literature [5, 6], to the best of our knowledge. However, with the widespread use of this device, Cardioband surgical explant might become more frequent in the future and Cardiac Surgeons may face this problem more frequently. In this perspective, the surgical technique needs to be standardized. Even though the removal is not technically demanding, as previously described, the management of the anchors may be challenging because they are deeply anchored in the annulus.

Therefore, the annulus preservation represents one of the major concerns. In the case presented, we considered that a conservative approach should be attempted by a plasty. We decided at first to preserve the valvular annulus by cutting the anchors by a Linston cutter and unscrewing the anchors one by one by means of a Bengolea clamp. Despite careful and gentle ablation of anchors, the annulus got damaged. Taking into account the deep perforations produced by the anchors, we considered that the annulus was definitively severely compromised.

We were thus forced to opt for traditional valve replacement in order to reduce the risk for further complications, potentially attendant to repairing attempts, and to guarantee the briefest possible time of aortic clamping. In fact, patients who have undergone a percutaneous procedure earlier are normally high-risk patients, for whom it is preferable to use the briefest cardiopulmonary bypass time as possible. For these reasons, the possibility to re-fix the Cardioband at the level of the posterior commissure was not taken into consideration.

We suggest that sparing the annulus should always be attempted at first, and only if the conservative approach is deemed impossible, a traditional valve replacement should be done.

Conclusion

This case report focuses on the removal technique of Cardioband system. In our opinion, although the removal technique could seem elementary and intuitive, sparing the annulus could represent a challenge for treating surgeons. In that regard, because this procedure is performed in high-risk patients, it needs to be formalized and standardized, in order to prevent complications and excessive duration of aortic clamping.

Funding

None.

Declarations

Ethics committee approval

Not required.

Statement of human and animal rights

This study was conducted ethically in accordance with the World Medical Association Declaration of Helsinki.

Informed consent

The patient gave his written informed consent to publish his case and images.

Conflict of interest

The authors declare no competing interests.