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Ann Thorac Surg 2004;77:1985-1988
© 2004 The Society of Thoracic Surgeons

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Original article: cardiovascular

Mitral valve repair with the Colvin-Galloway future band

^a Department of Cardiovascular Surgery, Hospital Lainz, University of Vienna, Vienna, Austria
^b Department of Cardiology, AKH, University of Vienna, Vienna, Austria

Accepted for publication November 12, 2003.

^* Address reprint requests to Dr Fasol, IMC—International Medical Center Krems-Hollenburg, Krustettnerstrasse, A-3506 Krems/Hollenburg, Austria
e-mail: rfasol{at}heart-surgeon.com

	Abstract

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BACKGROUND: A new annuloplasty device, the Colvin-Galloway Future Band, has been developed to allow simple and safe mitral valve repair surgery. Here we report its clinical use and the clinical results after a short-term, 2-year follow-up.

METHODS: We assessed the performance of this new device in 40 consecutive patients (55% male; mean age, 68.3 ± 8.1 years) who were operated on for mitral valve incompetence between 2001 and 2002. Ninety percent of these patients had associated surgical procedures. Clinical and echocardiographic assessment was performed perioperatively and at a mean follow-up of 16.5 ± 5.7 months (range, 6 to 25 months) in all patients (100%), permitting analysis of 55 patient-years.

RESULTS: Thirty-eight patients survived surgery, resulting in an overall early mortality of 5.0%. There were four noncardiac-related late deaths, resulting in an overall late mortality of 10.0%. Perioperative echocardiography showed no incidences of systolic anterior movement at the time of discharge from the hospital and satisfactory mitral repair results in 36 (95%) patients. At the time of the 2-year follow-up, echocardiography showed satisfactory mitral valve function in all but 2 patients (94%) and a significant postoperative ventricular remodeling: the left ventricular end-diastolic diameter decreased from 64.5 ± 6.2 mm preoperatively to 50.4 ± 9.5 mm postoperatively (p < 0.1). At the time of follow-up, 29 (90.6%) patients were in New York Heart Association functional class I or II, all of them describing their quality of life as "significantly improved" if compared with their preoperative status. There were no late reoperations and no thromboembolic, bleeding, or other complications.

CONCLUSIONS: The clinical results of the Colvin-Galloway Future Band in this short-term follow-up of patients undergoing complex mitral valve repair seem to be promising.

	Introduction

Top Abstract Introduction Patients and methods Results Comment References

 

Dr Fasol discloses that he has a financial relationship with Medtronic.

 

The experience of the last few years shows a change in concepts for mitral valve surgery. A trend toward simplified and streamlined reconstruction techniques, allowing more often the successful repair of the mitral valve and not replacement with artificial prostheses, may be observed [1–3]. To repair the mitral valve is considered to be the procedure of choice, and it seems to be generally accepted to be preferable to valve replacement. However, there is an endless discussion of various devices to be used or not to be used, even reports of attempts of annular stabilization in mitral repair without a prosthetic ring may be found lately [4], and controversy has flourished between partisans of ring flexibility and supporters of the remodeling concept [5].

The Colvin-Galloway Future Band (C-G Future Band) is a semirigid annuloplasty band that restores mitral annular dimension. Its design combines both remodeling and flexibility (Fig 1). Its low-profile band design makes it easy to implant and allows predictable remodeling of the annulus to maintain apposition of the anterior and posterior leaflets. We now report our initial experience and early results of repairing the mitral valve using this new device.

View larger version (125K): [in this window] [in a new window]   Fig 1. The semirigid Colvin-Galloway Future Band restores the normal shape and size of the mitral valve orifice and the physiologic annular ratio. Inset: Schematic drawing of a cross-section of the Colvin-Galloway Future Band showing the structure of the annuloplasty device: the metallic core (MP-35N alloy) is covered by silicone and is surrounded by a polyester fabric.

	Patients and methods

Top Abstract Introduction Patients and methods Results Comment References

Surgery was performed according to the hospital routine. After achieving cardiac arrest, the interatrial groove is incised and the right atrium dissected. With the left atrial roof exposed, the left atrial incision is carried out close to the mitral valve. A self-retaining retractor is used to expose the mitral valve. Accurate valve analysis using two conceptual approaches, the functional and segmental approaches, as advocated by Carpentier and associates [5], is postulated to be mandatory. Details of surgical repair procedures (as well as associated procedures) are listed in Table 1. The repair procedure is completed by the implantation of a C-G Future Band with nine sutures (Fig 2), allowing the surgeon to avoid putting sutures into the area of the anterior mitral annulus owing to the design of this annuloplasty device (Fig 1). Intraoperative and perioperative transesophageal Doppler echocardiography was used in every patient, and all patients were studied before discharge from hospital and at the time of follow-up in 2003. Echocardiographic assessment included evaluation of left ventricular end-diastolic and end-systolic diameters, as well as left ventricular function. Color Doppler evaluation was performed to determine the degree of mitral regurgitation (qualitative assessment, grade 1 to 3). In addition, transmitral gradients were calculated from the Doppler spectrum using the Bernoulli equation and the functional mitral valve area using the pressure–half-time formula. Postoperative events were categorized using the guidelines for reporting morbidity and mortality after valve operations [6].

View larger version (157K): [in this window] [in a new window]   Fig 2. Schematic drawing of the implanted Colvin-Galloway Future Band with nine sutures, allowing the avoidance of putting sutures into the area of the anterior mitral annulus owing to the design of this annuloplasty device. The design allows predictable remodeling of the annulus to maintain apposition of the anterior and posterior leaflets.

	Results

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	Comment

Top Abstract Introduction Patients and methods Results Comment References

In our own experience, we learned to quickly abandon nonrigid or flexible bands or rings because they resulted in early reoperations. Semirigid annuloplasty remodels the annulus, restoring its physiologic annular ratio [5], while providing flexibility at the posterior annulus [8]. It may be assumed that we should have learned the lesson that remodeling of the annulus is a vital part of any mitral valve repair procedure, and this should imply some rigidity of the prosthetic ring.

In the C-G Future Band concept the metallic core is made from MP-35N (registered trademark of SPS Technologies, Jenkintown, PA), a nonmagnetic, nickel-cobalt-chromium-molybdenum alloy possessing a combination of high tensile strength and durability. Furthermore, the C-G Future Band is longitudinally undeformable to avoid the pursestring effect or plication of the band when tying the annular sutures, in contrast to currently available flexible devices. If compared with circumferential supports like the Carpentier-Edwards Physio-Ring [5], the noncircumferential C-G Future Band may be considered a benefit for surgeons because visibility and access to the anterior portion of the mitral annulus may be limited in some patients and technically demanding. In these clinical situations, this semirigid band may be technically easier to implant by allowing the surgeon to avoid putting sutures into the area of the anterior mitral annulus owing to the design of this annuloplasty device.

The follow-up of all patients at 16.5 ± 5.7 months postoperatively showed satisfactory valve function in all but 2 (6.2%) patients, who had a moderate residual regurgitation (mitral insufficiency 2+). These 2 patients had a complex repair procedure including leaflet resections, polytetrafluoroethylene chordae implantation, and annulus decalcification in one of these patients. The repair result was judged overall not satisfactory, but the intraoperative transesophageal echocardiography did not show a severe incompetence, exceeding a moderate residual regurgitation (mitral insufficiency 2+), which would have resulted in a valve replacement procedure. However, the follow-up of these 2 patients did not show any changes in these two regurgitant valves, and both patients are still in New York Heart Association functional class II. Seven patients (21.9%) had a trivial residual regurgitation (mitral insufficiency 1+). Twenty-nine (90.6%) patients were in New York Heart Association functional class I or II, all of them describing their quality of life as "significantly improved" when compared with their preoperative condition. There were no late postoperative complications.

In conclusion, our early results of this series have been promising so far, although all patients but 4 have been complex mitral valve repair procedures with multiple associated procedures (Table 1). Nevertheless, although we are convinced that this new C-G Future Band annuloplasty device is easy to handle and simple to implant and supplies all required features to allow predictable remodeling of the annulus by restoring the physiologic annular ratio, longer follow-up times and larger patient populations are mandatory to allow a better judgment of long-term results.

	References

Top Abstract Introduction Patients and methods Results Comment References

 

1. Fasol R., Lakew F., Pfannmüller B., Slepian M., Joubert-Hubner E. Papillary muscle repair surgery in ischemic mitral valve patients. Ann Thorac Surg 2000;70:771-777.[Abstract/Free Full Text]
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3. Fasol R., Mahdjoobian K., Joubert-Hubner E. Mitral repair in patients with severely calcified annulus: feasibility, surgery and results. J Heart Valve Dis 2002;10:153-159.
4. Komoda T., Hubler M., Siniawski H., Hetzer R. Annular stabilization in mitral repair without a prosthetic ring. J Heart Valve Dis 2000;9:776-782.[Medline]
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6. Edmunds L.H., Clark R.E., Cohn L.H., Miller D.C., Weisel R.D. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Ann Thorac Surg 1988;46:257-259.[Medline]
7. Deloche A., Jebara V., Relland J., et al. Valve repair with Carpentier techniques: the second decade. J Thorac Cardiovasc Surg 1990;99:990-1002.[Abstract]
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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Manfred Deutsch Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Fasol, R. Articles by Binder, T. Search for Related Content PubMed PubMed Citation Articles by Fasol, R. Articles by Binder, T. Related Collections Valve disease