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 Table of Contents  
CASE REPORT
Year : 2015  |  Volume : 1  |  Issue : 2  |  Page : 200-202

Report of an external basal annuloplasty device for mitral regurgitation (basal annuloplasty of the cardia externally device implantation)


1 Department of Cardiothoracic Surgery, All India Institute of Medical Sciences, New Delhi, India
2 Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India
3 Department of Cardiac Surgery, Rush University Medical Center, Chicago, IL, USA

Date of Web Publication30-Sep-2015

Correspondence Address:
Dr. Milind Hote
Department of Cardiothoracic Surgery, All India Institute of Medical Sciences, New Delhi
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2395-5414.166342

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  Abstract 

We report the successful implant of an external basal annuloplasty device (basal annuloplasty of the cardia externally), which is a dimethyl silicone band, slipped around the base of the heart at the atrioventricular groove and the sub-annular myocardium to provide external myocardial support and mitral annuloplasty. The patient had ischemic heart disease with moderate functional mitral regurgitation which was reduced to mild regurgitation. The patient underwent coronary artery bypass during the same surgery.

Keywords: Basal annuloplasty of the cardia externally, external annuloplasty, mitral regurgitation


How to cite this article:
Hote M, Seth S, Choudhary SK, Raman J, Saini A, Kaushik M, Parakh N. Report of an external basal annuloplasty device for mitral regurgitation (basal annuloplasty of the cardia externally device implantation). J Pract Cardiovasc Sci 2015;1:200-2

How to cite this URL:
Hote M, Seth S, Choudhary SK, Raman J, Saini A, Kaushik M, Parakh N. Report of an external basal annuloplasty device for mitral regurgitation (basal annuloplasty of the cardia externally device implantation). J Pract Cardiovasc Sci [serial online] 2015 [cited 2020 Apr 2];1:200-2. Available from: http://www.j-pcs.org/text.asp?2015/1/2/200/166342


  Introduction Top


Successful surgery for mitral regurgitation (MR) was first reported as early as 1951 by Bailey et al.[1] Since that time, surgical interventions to treat MR have evolved tremendously. Less invasive options in treating MR will allow high-risk patients to seek anatomic therapy, whether surgical or percutaneous. New techniques will continue to be a dominant driver of surgical approaches to MR. Direct vision mitral annuloplasty was reported by Lillehei et al. in 1958.[2] Studies have shown that mitral repairs employing ring mitral annuloplasty have better durability than ringless repairs.[3] This observation may result from the fact that nearly all valves with significant chronic MR have some degree of annular dilation.

In this report, we present a new technique using a device for external annuloplasty called as the basal annuloplasty of the cardia externally (BACE) device. This device consists of a wide, clear dimethyl silicone band assembly [Figure 1] with inflatable silicone chambers and small belt loops of polyester around the band. The band is slipped around the base of the heart and positioned at the atrioventricular (AV) groove, covering some sub-annular ventricular myocardium. It is held in place through tabs on the polyester belt loops that are attached to the cardiac muscle by sutures. Chambers incorporated into the band are inflated by filling them with saline during implantation. The volume of saline can be adjusted by accessing through the subcutaneous ports. The filled chambers will add pressure at the appropriate points of the heart to re-shape the mitral valve annulus and also provides sub-annular myocardial support which will allow better closure of the mitral valve. The BACE device is deployed via median sternotomy on a beating heart. During the surgical procedure, the degree of reduction in MR is assessed dynamically by echocardiography.
Figure 1: The basal annuloplasty of the cardia externally device.

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  Case Report Top


We report our first experience with implantation of the BACE device.

The patient, a 48-year-old male was presented with coronary artery disease, moderate MR, moderate left ventricular (LV) dysfunction, and Class III angina. Coronary angiography revealed triple vessel disease and impaired LV dysfunction. He was scheduled for coronary artery bypass surgery with a possible mitral valve repair or replacement and was offered the option of a BACE device implant to which he agreed. The implantation of the BACE device was approved by the Institutional Ethics Committee. The procedure was explained to him in detail and a written and recorded consent was taken.

Surgery

A median sternotomy was done. For the surgical procedure, the pericardium was opened and heart was inspected. A pericardial cradle was created for better access. The circumference of the heart at the base was measured with a tape that could be slipped around the heart at the AV groove and the measurement was repeated at least once for confirmation. The measurement at the maximum dimensions just below the AV groove was selected. Once the measurement was verified, a BACE device of the measured size was selected. After selection of appropriate size, the BACE device was slipped around the heart and positioned at the level of the AV groove and overlapping the underlying ventricular muscle. The heart was lifted up and “positioned” by the Medtronic Starfish stabilizer applied close to the apex of the heart to facilitate this maneuver. The BACE device belt loops were secured on the atrial and ventricular side of the mitral annulus by placing one suture on individual belt loops with 4/0 polypropylene. These loops fixed the device to the epicardium, on the atrial and ventricular aspects.

Thereafter, coronary artery bypass graft (CABG) was performed with a left internal mammary artery graft to the left anterior descending (LAD coronary artery) and aortocoronary saphenous vein grafts to the posterior descending artery and diagonal artery on a beating heart. After the grafts were completed, the BACE device was also fixed anteriorly. The balloons within the silicone band were inflated. The transesophageal echo which had shown moderate MR previously, showed no regurgitation at the end of the procedure.

Subcutaneous ports were placed in the required location (a small subcutaneous pocket in the left sub costal quadrant of anterior abdominal wall). Through each port, the BACE device chambers were filled with additional 4–5 ml of saline, using a 5 ml syringe fitted with a standard needle.

Postprocedure

The patient was gradually mobilized. The mobilization period was prolonged because of LV failure but the patient was discharged after 17 days. There was mild MR at discharge [Figure 2], [Figure 3], [Figure 4].
Figure 2: Intraoperative photo of the basal annuloplasty of the cardia externally implant. White arrow shows the device.

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Figure 3: Echo before: Moderate mitral regurgitation.

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Figure 4: After implant: No mitral regurgitation after the implant.

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  Discussion Top


The original BACE device, proof-of-concept prototype (a band of surgical mesh that partially encircled the heart), was tested in a chronic study in Australia during 2000–2001 with 12 subjects.[4] All of these procedures were performed as an adjunct to conventional cardiac surgical procedures, which included CABG surgery, LV reconstruction, or both. All the twelve subjects underwent CABG. Ten of the twelve had LV reconstruction using a modified DOR procedure called as geometric endoventricular repair. All of the twelve subjects had moderate to moderately severe MR before surgery. The BACE procedure was performed with a polyester mesh, crafted on the operating table, and tailored to size. This was done in such a way as to eliminate MR as the subject was weaned off cardiopulmonary bypass. The results were encouraging. In the chronic study, the device significantly reduced the MR (mean preoperative grade of 2.8 to mean postoperative grade of 0.3 and 0.36 at 18 month follow-up), improving the New York Heart Association (NYHA) functional status (mean NYHA of 3.1 preoperative to 1.1 at 18 months follow-up) and increasing LV ejection fraction (average of 25% preoperative to 42% at 18 months follow-up). There were no device-related adverse events during the 18 months of follow-up, showing the durability of the procedure.

Preliminary data with the current version of the BACE device are available on 14 patients in India. Follow-up data have indicated significant improvements in the patients' functional status and quality of life as measured by NYHA scores (from 3.1 to 1.2) as well as ejection fractions (from 25 to 44.5), along with a significant drop in the degree of MR (2.8–0.3).

We have in this brief case report, reported our first experience with the BACE device. If successful in more patients, it will provide another option for treating patients with functional MR in patients undergoing beating heart surgery.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
Bailey CP, O'Neill TH, Glover RP, Jamison WL, Redondo-Ramirez HP. Surgical repair of mitral insufficiency (preliminary report). Dis Chest 1951;19:125-37.  Back to cited text no. 1
    
2.
Lillehei CW, Gott VL, Dewall RA, Varco RL. The surgical treatment of stenotic or regurgitant lesions of the mitral and aortic valves by direct vision utilizing a pump-oxygenator. J Thorac Surg 1958;35:154-91.  Back to cited text no. 2
    
3.
Cohn LH, Couper GS, Aranki SF, Rizzo RJ, Kinchla NM, Collins JJ Jr. Long-term results of mitral valve reconstruction for regurgitation of the myxomatous mitral valve. J Thorac Cardiovasc Surg 1994;107:143-50.  Back to cited text no. 3
    
4.
Raman J, Hare D, Storer M, Hata M. Epicardial cardiac basal annuloplasty: Preliminary findings on extra-cardiac mitral valve repair. Heart Lung Circ 2009;18:401-6.  Back to cited text no. 4
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4]



 

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