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Ann Thorac Surg 2006;82:1356-1361
© 2006 The Society of Thoracic Surgeons

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Original Articles: Cardiovascular

Edge-to-Edge Technique for Mitral Valve Repair: Medium-Term Results With Echocardiographic Follow-Up

^a Department of Cardiothoracic Surgery, Cardiothoracic Centre Liverpool, Liverpool, United Kingdom
^b Department of Research and Development, Cardiothoracic Centre Liverpool, Liverpool, United Kingdom

Accepted for publication May 4, 2006.

^_* Address correspondence to Dr Kuduvalli, Cardiothoracic Surgery, Cardiothoracic Centre NHS Trust, Thomas Dr, Liverpool L14 3PE, United Kingdom (Email: manojkud{at}hotmail.com).

	Abstract

Top Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
BACKGROUND: The follow-up data for the Alfieri edge-to-edge technique of mitral valve repair is still a matter of interest. We describe the medium-term results of a single surgeon's practice with clinical and echocardiographic follow-up.

METHODS: Between October 1998 and July 2003, 41 patients underwent the Alfieri repair. Mean age of the patients was 68 years, 34.2% were female, 26 (63.41%) had New York Heart Association (NHYA) class III symptoms, and 19 (46.3%) had concomitant coronary disease. Preoperatively, 26 patients had grade 4+, 12 patients had grade 3+, and 3 patients had grade 2+ mitral regurgitation. The pathologies included myxomatous degeneration (73.2%), ischemic cardiomyopathy (12.2%), rheumatic (4.9%), dilated cardiomyopathy (2.4%), previous infection (2.4%), and indeterminate pathology (4.9%). Thirty-three patients (80.4%) had a ring annuloplasty, and 17 (41.4%) had concomitant coronary surgery. Median duration of echocardiographic follow-up was 22.1 months (range, 0.2 to 60.1).

RESULTS: Hospital mortality was 4.8% (2 of 41). Four patients underwent reintervention on the mitral valve. At follow-up, 26 patients (66.6%) were in NYHA class I. The actuarial freedom from death or reoperation at 5 years was 80.4%. Transthoracic echocardiography was performed in 94.3% of the 35 hospital survivors who did not undergo reoperation. Twenty-nine patients (87.8%) had grade 0–1+ mitral regurgitation, and the remainder had grade 2+ mitral regurgitation. All patients discharged from hospital were alive in December 2005.

CONCLUSIONS: The Alfieri edge-to-edge repair for mitral regurgitation is a safe and useful technique and should be included in the armamentarium of the mitral valve surgeon.

	Introduction

Top Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
Since its introduction in 1995 [1] for repair of mitral valves with prolapsing anterior leaflet, the edge-to-edge technique for mitral valve repair has been used to repair mitral valves in diverse situations [2, 3]. It has been compared with mitral valve replacement, with favorable outcomes in patients with bileaflet prolapse and ischemic mitral regurgitation [4]. This type of repair has been put forward as a simple, effective, and durable solution to complex mitral valve problems and can be a useful addition to the surgical armamentarium in mitral valve reconstruction [5]. This paper describes the experience of a single surgeon (B.M.F.) with this technique, with medium-term clinical and echocardiographic follow-up.

	Patients and Methods

Top Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
The study was approved by the Department of Research and Development of our institution. Individual consent was waived because individual patients were not identified.

Patients
Between October 1998 and July 2003, 41 patients underwent mitral valve repair using the edge-to-edge technique by a single surgeon at our institution. During the same period, a total of 74 patients underwent mitral valve repair with other techniques under the same surgeon 65 cases of quadrangular resection of P2 segment and ring annuloplasty, 3 cases of anterior leaflet repair and ring annuloplasty, 3 cases of isolated ring annuloplasty, and 3 cases of isolated anterior leaflet repair without annuloplasty. One hundred and thirty-three patients underwent mitral valve replacement during this period.

The preoperative, intraoperative, and postoperative data were derived from a detailed case note review of all the patients. The mean age was 68 yearsm and 34.2% of the patients were female. At admission, 5 patients (12.1%) were in New York Heart Association (NYHA) functional class I, 5 (12.1%) were in class II, 26 (63.41%) were in class III, and 5 (12.1%) were in NHYA class IV. Mitral regurgitation (MR) was characterized as mild (1+), moderate (2+), moderate-severe (3+), or severe (4+) based on preoperative transthoracic echocardiography. Nineteen of the 41 patients underwent preoperative transesophageal echocardiography as well. Preoperatively, 26 patients (63.4%) had grade 4+, 15 (29.2%) had grade 3+, and 3 (7.3%) had grade 2+ MR. The grade 2+ MR was surgically treated only in patients having concomitant coronary disease. The etiology of mitral insufficiency is shown in Table 1.

Choice of Technique
The Alfieri edge-to-edge technique was chosen predominantly for valves that showed bileaflet or isolated anterior leaflet prolapse, usually secondary to myxomatous degeneration, or in patients with posterior leaflet prolapse with calcified annulus, or other unfavorable pathology. They were also used in some patients with poor leaflet coaptation due to restricted leaflet motion. Any valves that were amenable to more conventional methods of repair were not treated with the edge-to-edge technique.

Operative Details
All the operations were performed through a conventional median sternotomy. Aortic and bicaval cannulation were used for normothermic cardiopulmonary bypass. Cardioplegic arrest was achieved using antegrade warm blood induction and continuous retrograde maintenance. The mitral valve was approached through the left atrium through a paraseptal incision, after dissection in the interatrial groove. The valve was examined and the morphology determined. The mechanism of mitral regurgitation in the 30 patients showing evidence of myxomatous degeneration is shown in Table 2. Chordal rupture was present in 13 patients (31.7%). Three patients (7.3%) had restricted posterior leaflet motion. The annulus was sized and was found dilated in 25 patients (60.9%), and normal in 13 (31.7%). The annulus was severely calcified in 3 cases (7.3%). The valve was tested, and the location of the regurgitation was determined by forceful injection of normal saline into the left ventricle.

Thirty-three (80.4%) of the 41 patients underwent a ring annuloplasty. Of these, 32 patients had a St. Jude Seguin semirigid annuloplasty ring (St. Jude Medical, Minneapolis, Minnesota) implanted, and 1 patient had a Carpentier-Edwards semirigid Physio-Ring (Baxter Healthcare, Edwards Division, Santa Ana, California) implanted. The sizes of the rings were as follows: one 28-mm, seven 34-mm, nine 36-mm, five 38-mm, and eleven 40-mm rings. The 28-mm ring was used in a patient with ischemic pathology for his mitral regurgitation, and he required a subsequent edge-to-edge stitch for residual regurgitation.

Of the 8 patients who did not have annuloplasty rings implanted, 4 were done in the early part of the experience when the importance of the additional ring annuloplasty for reinforcing the edge to edge repair was not appreciated and rings were used only when the mitral annulus was significantly dilated. In 3 other patients, the posterior mitral annulus was very severely calcified and hence precluded safe implantation of an annuloplasty ring. Another patient did not have a ring implanted owing to extremely poor visualization of the mitral valve with the standard paraseptal incision. We were hesitant to use a more extensive exposure technique because of very poor tissue quality in this 78-year-old man.

In all cases, the "valve area" was estimated with Hegar dilators after the reconstruction was complete. A global valve area of more than 2.5 cm² was considered adequate for most patients, as described by Alfieri and coworkers [5].

After the repair was complete, competence of the valve was tested again with forceful injection of saline into the left ventricle. There was no leak in 32 cases (78.0%) and a trace of regurgitation, which was deemed acceptable, in the remaining 9 patients. Intraoperative transoesophageal echocardiography was used to assess the valve after weaning from cardiopulmonary bypass in 26 cases (63.4%). There was no mitral regurgitation in 15 of these 26 patients, and a trace of or mild regurgitation in the remaining 11 patients.

Additional cardiac procedures were performed in 18 patients (43.9%). Sixteen patients underwent coronary artery bypass grafting (ranging from 1 to 5 bypass grafts), 1 patient underwent coronary artery bypass grafting and left ventricle aneurysmectomy, and 1 patient underwent direct closure of a secondum atrial septal defect.

Median cardiopulmonary bypass time and cross-clamp times were 98 and 66.5 minutes, respectively. After excluding the patients undergoing concomitant procedures, the cardiopulmonary bypass and ischemic times were 83 and 61.5 minutes, respectively.

Patients in whom an annuloplasty ring was implanted received postoperative oral anticoagulation therapy for a period of 3 months only. Long-term anticoagulation was prescribed only if there was a history of atrial fibrillation.

Follow-Up
All hospital survivors were followed up in our outpatient clinics. The median duration of clinical follow-up was 19.4 months (range, 1.6 to 60.1). Detailed information including NYHA functional status, cardiac rhythm, any complications, and present medications were recorded. Transthoracic echocardiography was carried out in 33 of the 35 surviving patients who had not undergone any reintervention on the mitral valve. The median duration of echocardiographic follow-up was 22.1 months (range, 0.2 to 60.1).

To derive the actuarial survival and actuarial freedom from death or repeat intervention at 5-year follow-up, the vital status of all the surviving patients and reoperation data was recorded as of December 2005.

Statistical Methods
Owing to nonnormality of data, continuous variables are shown as median with range. Proportions are expressed as percentages. Comparisons were made with ² test for trend. Survival and freedom from reoperation were analyzed with Kaplan-Meier actuarial methods [7]. In all cases, a p value less than 0.05 was considered significant. All statistical analysis was performed retrospectively with SAS for Windows Version 8.2 (SAS Institute, Cary, North Carolina).

	Results

Top Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
Mortality
There were 2 in-hospital deaths. One was a 65-year-old man who underwent mitral repair without an annuloplasty ring, with four coronary artery bypass grafts. Intraoperative transesophageal echocardiography revealed a trace of mitral regurgitation. He was discharged from the intensive care unit to the ward on the third postoperative day. He suffered a prolonged cardiac arrest with ventricular fibrillation on the ward on the fourth postoperative day. He sustained severe neurologic injury due to prolonged resuscitation and died on the 19th postoperative day. A postmortem examination revealed the repair to be intact, with patent coronary artery bypass grafts.

The second patient was a 60-year-old man who presented in extremis with acute mitral regurgitation, pulmonary edema, low cardiac output, and severe renal failure. He had an intra-aortic balloon pump inserted preoperatively. His preoperative serum creatinine was greater than 500 mmol/L. He died of multiorgan failure on the fourth postoperative day.

There were no late deaths during the period of follow-up. The actuarial overall survival at 5 years was 95.1% (Fig 1).

View larger version (9K): [in this window] [in a new window]   Fig 1. Freedom from death after the Alfieri repair at 5 years.

Reoperation
Two patients required reintervention on the mitral valve during the same hospital stay. One was a 68-year-old woman with ischemic mitral regurgitation who underwent edge-to-edge repair with a ring annuloplasty and four coronary artery bypass grafts. Intraoperative transoesophageal echocardiography had shown mild mitral regurgitation. She underwent reoperation on the 41st postoperative day because of recurrent mitral regurgitation and persistent heart failure. The annuloplasty sutures had dehisced at the 5 to 10 o'clock position. Mitral valve replacement was performed with a mechanical prosthesis.

The other patient was a 77-year-old woman undergoing mitral repair and three coronary bypass grafts, in whom an annuloplasty ring could not be placed owing to severe annular calcification. There was disruption of the repair postoperatively, with the edge-to-edge sutures having cut out of the anterior leaflet, causing severe regurgitation. Mitral valve replacement was performed with a bioprosthesis.

There was 1 late reoperation in a 30-year-old woman, about a month after she was discharged from hospital after her initial repair. She had an edge-to-edge suture placed between the A3 and P3 segments. Although the repair appeared satisfactory on testing intraoperatively, she had mild to moderate mitral regurgitation on her predischarge echocardiogram. Transthoracic echocardiography at outpatient follow-up showed severe mitral regurgitation. The repair appeared intact at reoperation, and the annuloplasty ring was in place. As it was not possible to isolate the cause of the mitral regurgitation, mitral valve replacement was done with a mechanical prosthesis.

A 74-year-old man had progressively worsening mitral regurgitation and symptoms. He had ischemic mitral regurgitation and had undergone a concomitant left ventricular aneurysmectomy with the edge-to-edge repair carried out through the left ventricle. Annuloplasty was not carried out. He was readmitted for mitral valve reintervention through a right thoracotomy to avoid damage to the patent coronary grafts. Femoral cannulation was attempted for cardiopulmonary bypass as he would not tolerate one-lung anesthesia. He had severe arteriopathology, and the procedure had to be abandoned owing to no vascular access in both femoral arteries. This case has been included as a reintervention in the statistical analysis on an intention-to-treat basis.

The actuarial freedom from death or reoperation at 5 years was 80.4% (Fig 2).

View larger version (10K): [in this window] [in a new window]   Fig 2. Freedom from death or repeat intervention after the Alfieri repair at 5 years.

Of the 39 hospital survivors, 15 (38.5%) were taking angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists, 13 (33.3%) were taking diuretics, 8 (20.5%) were on beta-blocker therapy, and 14 (35.9%) were on a regimen of digoxin or other antiarrhythmic medications.

Echocardiographic Follow-Up
Transthoracic echocardiography was performed on an outpatient basis on 33 (94.3%) of the 35 hospital survivors who had not undergone reintervention on the mitral valve. Six (18.1%) of these patients had no mitral regurgitation, 23 (69.6%) had grade 1+ MR, and 4 (12.1%) had grade 2+ MR.

Twenty seven patients had good, 5 had moderate, and 1 had poor left ventricular functions, as defined earlier. Two patients with preoperatively poor LV function had improved to moderate LV function after repair. There were no patients in whom LV function had deteriorated during the period of follow-up. A comparison of preoperative and postoperative echocardiographic data is shown in Table 4.

	Comment

Top Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
Mitral valve repair has been shown to produce superior clinical outcomes compared with mitral valve replacement [8]. The double-orifice technique introduced by Alfieri and colleagues [1] has been shown to provide a simple surgical solution to repair regurgitant mitral valves with varied morphologies that might otherwise need complex surgical techniques for their correction [5]. It has been used in diverse morphologic settings with satisfactory clinical outcomes [2, 3].

The largest series of patients whose follow-up data have been published is that of Alfieri and colleagues themselves, and includes 260 patients undergoing central edge-to-edge repair. One of the deficiencies of that study, however, is the lack of echocardiographic data, and that is acknowledged by the authors themselves [5]. In another study, Kherani and colleagues [9] have 25% postoperative echocardiographic follow-up. There are few studies with complete or almost complete echocardiographic follow-up in the medium to long term [6, 10, 11].

Our series shows a significant improvement in NYHA functional class at medium-term follow-up. It compares well with similar improvements in symptomatic status reported in various other similar studies [2, 4, 5].

Suboptimal results have been reported with the edge-to-edge technique when annuloplasty is not added to the repair [12]. Even though it is difficult to draw a similar conclusion from our study, it is of interest to note that 3 of 4 of our patients who underwent reintervention had either not had an annuloplasty (2 cases) or the sutures holding the annuloplasty ring in place had dehisced over an area (1 case).

Actuarial overall survival at 5 years was 95.1% in our series, which is comparable to other reports [5, 10]. Combined freedom from death or reoperation in our patients at 5 years was 80.4%. Alfieri's own large series of 260 patients [5] reports a 5-year freedom from reoperation at 90.0%. These comparatively better results probably reflect their larger experience with the procedure. Oc and associates [10] have reported a 5-year freedom from reoperation at 94.0% ± 4.4%. However, this is in a series of patients exclusively with Barlow's disease, for which the results are known to be better compared with other pathologies.

Echocardiographic follow-up was possible in our series for 94.3% of the 35 hospital survivors who had not undergone reintervention on the mitral valve. Comparison of preoperative and postoperative echocardiographic findings show a significant improvement in mitral regurgitation in the majority of the patients, with 87.8% of patients having either no MR or grade 1+ MR. These findings add to the body of existing evidence supporting the durability of the edge-to-edge repair in the medium term.

Study Limitations
There are some weaknesses in reporting this series. Intraoperative transesophageal echocardiography was used only in 63.4% of patients, because of limitations in availability of the service in the initial part of our experience. Follow-up transthoracic echocardiography could not be completed for all patients. Although a 100% echocardiographic follow-up would have been ideal, we could still carry this out for more than 90% of our patients, which is better than in most other reported series. We were unable to compare the preoperative and postoperative left ventricular dimensions, and the dimensions of the left atrium because, although the majority of the echocardiograms done during follow-up reported these data, they were lacking in most of the preoperative echocardiograms. We, unfortunately, do not have data on mitral valve gradients in the late echocardiograms. However, 30 of the 33 patients who underwent late echocardiograms had an effective mitral valve area of greater than 2.0 cm². Hence, it is unlikely that these patients had any significant gradients. All 3 patients with mitral valve areas of 2.0 cm² or less were in NHYA class I at clinical follow-up, with only 1 of these patients, a man with ischemic cardiomyopathy and moderately impaired left ventricle, taking any diuretics.

Conclusion
The edge-to-edge repair has proven its hemodynamic value in both in vivo [13] and computational models [14]. This report further substantiates the clinical and echocardiographic follow-up of this technique. With the advent of various minimally invasive [15] and percutaneous [16] approaches to mitral valve repair, this simple and efficient technique may have an increasingly important role to play in the future. It is a useful and safe technique, especially for situations in which more conventional repair techniques may not be suitable, or very complex repair techniques may not be desirable, and it should be a part of the armamentarium of the cardiac surgeon involved in mitral valve surgery.

	Acknowledgments

Top Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
We acknowledge the immense cooperation and help from the echocardiographers in our institution, without whose support this study could not have been completed.

	References

Top Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 

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