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J Thorac Cardiovasc Surg 2008;136:1200-1206
© 2008 The American Association for Thoracic Surgery

Surgery for Acquired Cardiovascular Disease

How does the use of polytetrafluoroethylene neochordae for posterior mitral valve prolapse (loop technique) compare with leaflet resection? A prospective randomized trial

Volkmar Falk, MD, PhDa,*, Joerg Seeburger, MDa,*,*, Markus Czesla, MDa, Michael A. Borger, MD, PhDa, Julia Willige, BSca, Thomas Kuntze, MDa, Nicolas Doll, MD, PhDa, Franka Borger, MDa, Patrick Perrier, MDb, Friedrich W. Mohr, MD, PhDa

a Heart Center Leipzig, Leipzig, Germany
b Cardiovascular Center Bad Neustadt, Bad Neustadt, Germany

Received for publication May 10, 2008; revisions received July 9, 2008; accepted for publication July 14, 2008.

* Address for reprints: Joerg Seeburger, MD, Heart Center Leipzig, Leipzig University, Struempelstrasse 39, 04289 Leipzig, Germany. (Email: j.seeburger{at}web.de).


   Abstract
Top
 Abstract
Introduction
 Materials and Methods
 Results
 Discussion
 Limitations
 Conclusions
 References
 
Objective: Mitral valve surgery for posterior mitral leaflet prolapse consists mostly of leaflet resection, but implantation of premeasured polytetrafluoroethylene neochordae (ie, loops) is another option. The aim of this prospectively randomized trial was to determine how preservation of leaflet structure in combination with premeasured neochordae compares with the widely adopted technique of leaflet resection.

Methods: A total of 129 patients with severe mitral regurgitation, with a mean mitral regurgitation grade of 3.6 ± 0.6, underwent minimal invasive mitral valve surgery through a right lateral mini-thoracotomy. The mean age was 59.5 ± 12 years, 90 patients were male, the mean preoperative ejection fraction was 65% ± 8%, and the mean New York Heart Association functional class was 2.1 ± 0.7. Posterior mitral leaflet prolapse was diagnosed in all patients. Randomization was performed preoperatively, and crossover was allowed if the surgeon deemed it medically necessary. Crossover from resection to loops occurred in 9 patients, and crossover from loops to resection occurred in 3 patients.

Results: Mitral valve repair was accomplished in all patients (n = 129, 100%), and all patients received an annuloplasty ring. The mean number of loops implanted on the posterior mitral leaflet was 3.2 ± 0.9, with a mean length of 13.3 ± 2.2 mm. The mean duration of cardiopulmonary bypass was 135 ± 37 minutes and the mean aortic crossclamp time was 82 ± 26 minutes in all patients, with no significant difference between groups. Intraoperative transesophageal echocardiography showed a significantly longer line of mitral valve leaflet coaptation after implantation of loops (7.6 ± 3.6 mm) than after resection (5.9 ± 2.6 mm; P = .03). Thirty-day mortality was 1.6% for the entire group (2/129), with both deaths occurring in the loop group. Cause of death was massive pulmonary embolism in 1 patient and acute right heart failure in 1 patient. Early and mid-term echocardiographic follow-up revealed excellent valve function in the majority of patients, with no significant difference in mitral orifice area (3.6 ± 1.0 cm2 vs 3.7 ± 1.1 cm2, P = .4).

Conclusion: Both repair techniques for posterior mitral leaflet prolapse are associated with excellent results and appear comparable in the early postoperative course. The loop technique, however, results in a significantly longer line of leaflet coaptation and may therefore be more durable. Longer follow-up is required.

Abbreviations and Acronyms MR = mitral regurgitation; MV = mitral valve; PTFE = polytetrafluoroethylene


   Introduction
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 Abstract
 Introduction
Materials and Methods
 Results
 Discussion
 Limitations
 Conclusions
 References
 


Formula

Earn CME credits at http://cme.ctsnetjournals.org

 

Several well-described techniques are available for mitral valve (MV) repair.1-3Go For patients with prolapse of the middle portion of the posterior leaflet (P2), quadrangular resection of the prolapsing segment, as introduced by Carpentier1Go in 1983, is the most common type of repair. This technique is usually performed in association with plication of the mitral annulus or with a sliding annuloplasty. Although effective, these techniques result in immobilization of the posterior leaflet and impair, to some extent, its physiologic role.4Go New methods of preserving the posterior leaflet by use of polytetrafluoroethylene (PTFE) neochordae have recently been proposed.3,5,6Go Although the early and mid-term results for this new procedure are promising,6Go only retrospective studies have been performed to date. We therefore performed a prospective, randomized clinical trial comparing the use of PTFE neochordae with preservation of the posterior MV leaflet (loop technique) with leaflet resection in patients with prolapse of the posterior leaflet.


   Materials and Methods
Top
 Abstract
 Introduction
 Materials and Methods
Results
 Discussion
 Limitations
 Conclusions
 References
 
Patients
Patients with isolated prolapse of the posterior leaflet (based on preoperative transthoracic echocardiography findings) undergoing MV repair at the Heart Center Leipzig, Leipzig, Germany, and Cardiovascular Center Bad Neustadt, Bad Neustadt, Germany institution between May of 2005 and October of 2007 were eligible for the study. Of 896 patients who underwent minimally invasive MV surgery during the study period, 326 had no prolapse and 273 had anterior or bileaflet prolapse and therefore were ineligible. A total of 297 patients had isolated posterior mitral leaflet prolapse during the study period, of whom 129 (43.4%) were included in the study.

A total of 129 patients with severe mitral regurgitation (MR), with a mean MR grade of 3.4 ± 0.6, underwent minimally invasive MV surgery through a right lateral mini-thoracotomy. The mean patient age was 59.5 ± 12 years, and 90 patients (69.8%) were male. The mean preoperative left ventricular ejection fraction was 65% ± 8% for the entire group, and the mean New York Heart Association functional class was 2.1 ± 0.7. All patients were diagnosed with posterior mitral leaflet prolapse. MV pathology was myxomatous in all patients. The patient characteristics are shown in Table 1 .


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  		Table 1 Patient characteristics at baseline
 
Randomization and Ethics Approval
Treatment assignment was randomized on a 1:1 basis using a computerized random number generator. Randomization was performed immediately before surgery via a sealed envelope, and crossover was allowed if the surgeon deemed it medically necessary. The study was approved by our University Ethics Committee, and patients gave written, informed consent.

Surgical Approach
A minimally invasive approach was applied in all patients as previously described.7,8Go In brief, cardiopulmonary bypass was instituted via femoral arterial and venous cannulation through a 3- to 4-cm transverse incision in the right groin. The tip of the venous cannula was positioned under transesophageal echocardiographic guidance at the junction of the inferior cava and the right atrium. Mild hypothermia (34°C) was used, and vacuum-assisted venous drainage was applied. A right lateral mini-thoracotomy of 5 to 6 cm in length was performed in the fourth intercostal space. A port-access video camera was inserted, and a transthoracic aortic crossclamp was used.9Go Antegrade crystalloid Bretschneider cardioplegia (2 liters) was administered directly into the aortic root and repeated when arrest times exceeded 90 minutes. The surgical field was flooded with carbon dioxide throughout the procedure. MV repair techniques are discussed below. De-airing was performed by filling the left atrium with saline during closure and via the cardioplegia puncture site on the ascending aorta. Intraoperative data are depicted in Table 2 .


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  		Table 2 Intraoperative data
 
Mitral Valve Repair Techniques
Details regarding the performance of the resection and loop repair techniques have been described extensively.1,3-5,10,11Go In patients randomized to receive MV leaflet resection, a standard quadrangular resection of the redundant posterior leaflet tissue was used, followed by approximation of the leaflet remnants using interrupted sutures. The MV repair was completed by a sliding annuloplasty or annular plication whenever necessary. Patients who were randomized to the loop technique underwent our standard approach: The correct length of the PTFE loops (Gore-Tex, WL Gore & Associates, Flagstaff, Ariz) was assessed using a custom-made caliper, the premade loops were then anchored to the body of the corresponding papillary muscle, and the free loops were attached to the free margin of the prolapsing segment of the posterior leaflet. All patients received an annuloplasty ring, which was a complete, rigid ring (Carpentier-Edwards Physio, Edwards Lifesciences, Irvine, Calif) in the majority of cases. The ring was sized according to the size of anterior MV leaflet and the intertrigonal distance.

Follow-up
Follow-up was performed at 6 months and at 1 year postoperatively by transthoracic echocardiography and clinical examination. Echocardiographic follow-up was 100% complete at discharge from hospital, 59% (76) complete at 6 months, and 31% (50) complete at 1 year.

Statistical Analyses
Categoric variables are expressed as proportions, and continuous variables are expressed as mean ± standard deviations throughout the article. Comparison within and between groups was performed using paired and unpaired Student t tests, respectively. Sample size calculations were based on the ability to detect a significant difference between groups in the postoperative MV orifice area of 0.5 cm2 or more and a difference in leaflet coaptation length of 1.5 mm or more. These expected values were based on a retrospective analysis of our database. Data were analyzed on an intention-to-treat basis. All analyses were performed using SAS JMP7.0 (SAS Institute, Cary, NC). The standard guidelines for reporting morbidity and mortality after cardiac valvular operations were applied.12Go


   Results
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 Abstract
 Introduction
 Materials and Methods
 Results
Discussion
 Limitations
 Conclusions
 References
 
Baseline patient demographics are displayed in Table 1. There were no significant differences between the 2 groups of patients for any of the listed variables, with the exception of a higher prevalence of hypercholesterolemia in the patients undergoing loop implantation.

Intraoperative Course
Successful MV repair was accomplished in all patients. Crossover from resection to loops occurred in 9 patients, and crossover from loops to resection occurred in 3 patients (Figure 1 ). Seven patients received both treatment modalities and were considered as dropouts. Overall, 69 patients received treatment with the loop technique, and 53 patients received treatment with the leaflet resection technique (Figure 1). Table 2 displays the intraoperative data for both groups of patients. There were no significant differences between groups for any of the variables listed.


Figure 1
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  		Figure 1. Baseline, randomization, and intraoperative management. A total of 129 patients were randomized for MV repair using the loop technique or leaflet resection technique. After crossover and dropouts, 69 patients received loops and 53 patients received resection.

 
Leaflet resection was performed in all 53 patients of the resection group. Of the 69 patients who underwent the loop technique, the mean number of loops implanted on the P2 segment was 3.2 ± 0.9. The mean length of loops was 13.3 ± 2.2 mm.

MR grading at baseline was 4+ in 35 patients (26%), 3+ in 77 patients (61 %), and 2+ in 17 patients (13 %). After surgery, 112 patients (86.8%) had 0 (none or trace) and 17 patients (13.2 %) had 1+ (mild) MR. The mean MR grade decreased from 3.4 ± 0.6 at baseline to 0.2 ± 0.5 before discharge in the loop group and from 3.4 ± 0.5 to 0.1 ± 0.3 in the resection group (both P < .001). Systolic anterior motion of the anterior leaflet was not observed in any patient after either repair technique. Intraoperative transesophageal echocardiography showed a significantly longer line of leaflet coaptation after implantation of loops (7.6 ± 3.6 mm) than after leaflet resection (5.9 ± 2.6 mm; P = .03).

Left ventricular ejection fraction, left atrial size, left ventricular volume, MV orifice area, and transvalvular gradients and velocities showed significant alteration from baseline to after surgery for both groups of patients (Table 3 ). However, there were no significant differences between groups for any of these outcomes. Analyses according to intention-to-treat and actual treatment received did not alter our findings.


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  		Table 3 Echocardiographic outcomes before and after surgery
 
Morbidity and Mortality
Patients were transferred from the operating room to either the postanesthetic recovery unit (n = 55) or the intensive care unit (n = 74), with a mean stay of 4.1 ± 1.9 hours and 23.0 ± 20.7 hours, respectively. Reoperation for bleeding occurred in 4 patients (5.8%) in the loop group and 2 patients (3.8%) in the leaflet resection group. Acute renal failure with indication for hemodialysis occurred in 2 patients (2.9%) in the loop group and in none of the resection group. All perioperative complications are listed in Table 4 . There were no significant differences between the 2 groups of patients for any complication.


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  		Table 4 Early postoperative complications
 
There were 2 perioperative (in-hospital) deaths, both occurring in the loop group. One death was due to massive pulmonary embolism, and 1 death was due to acute right heart failure. Thirty-day mortality was 1.6% for the entire patient cohort.

During follow-up, there were no episodes of thromboembolic events, myocardial infarction, stroke, endocarditis, recurrent mitral insufficiency, or valve-related reoperations in either group of patients. In addition, there were no deaths during follow-up. The mean New York Heart Association functional class was 1.2 ± 0.4 versus 1.1 ± 0.3 6 months postoperatively and 1.3 ± 0.5 versus 1.0 ± 0.6 1 year postoperatively in the loop and leaflet resection groups, respectively.

Echocardiographic Follow-up
Transthoracic echocardiography was performed 6 months and 1 year after surgery (Table 5 ). No significant differences were detected between the 2 groups with regard to left ventricular ejection fraction, MR grade, MV orifice area, or transvalvular velocities or gradients.


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  		Table 5 Echocardiographic follow-up
 

   Discussion
Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
Limitations
 Conclusions
 References
 
Reconstructive MV surgery aims for restoration of physiologic leaflet motion, creation of an adequately sized mitral orifice with a sufficient line of leaflet coaptation, and stabilization of the mitral annulus.1,11Go Despite the fact that early and long-term outcomes clearly favor MV repair over replacement, less than 60% of patients requiring MV surgery currently undergo a reparative procedure.13Go The most popular technique for correction of myxomatous posterior leaflet disease is quadrangular or, more recently, triangular leaflet resection14,15Go combined with a ring annuloplasty. Although these techniques have provided durable and hemodynamically satisfactory results with good long-term freedom from valve-related reoperation, partial resection of the posterior leaflet changes the anatomic and physiologic function of the MV. Reapproximation of the remnants of the posterior leaflet after resection increases its stiffness, restricts its motion, and leads to limited surface availability for coaptation with the anterior leaflet. In addition, an annular plication or sliding annuloplasty procedure is often required after leaflet resection, further increasing leaflet restriction and surgical complexity. Such annuloplasty procedures and their real or perceived complexity may be contributing to the suboptimal MV repair rate in many cardiac surgery centers.13Go

The concept of preserving the posterior leaflet using PTFE neochordae, rather than partial resection, has been simultaneously developed by various groups.3,4,16Go The rationale of this approach follows several principles of reconstructive MV surgery: provide the largest possible orifice area, maximize the leaflet coaptation area, preserve ventriculo-annular continuity, and minimize leaflet tension. On the basis of these principles, we hypothesized that leaflet preservation with PTFE neochordae formation may optimize valvular hemodynamics and durability.

The loop technique is a modification of the use of standard PTFE sutures to create neochordae, a technique that has been successfully used for many years to correct prolapse of the anterior MV leaflet.17Go The loop technique uses 4 premade PTFE (Gore-Tex) loops to facilitate chordal replacement, particularly when performed through a right lateral mini-thoracotomy.3,5,6,10Go Our group recently reported excellent early and mid-term results of this technique, with a 97.4% freedom from valve related reoperation rate 3 years after single or bileaflet prolapse repair.5,6Go Because reoperations for failed MV repair tend to occur in the early postoperative period, at a mean of 15 months in a large series from the Cleveland Clinic,18Go we are confident that this reoperation rate should remain low over time. Although we originally developed the loop technique as a method of correcting anterior leaflet prolapse through a minimal invasive incision, we have since applied the technique to correction of posterior leaflet prolapse, as well as surgery, through a full sternotomy as we become increasingly confident with the positive results.

The current prospective randomized trial was conducted to compare the early outcome of the loop technique with the more established technique of quadrangular leaflet resection in patients with posterior MV prolapse. We chose to focus on patients with isolated posterior prolapse because this pathology represents the most frequently repaired form of MR. All valves could be successfully repaired in the current study, yielding an MV repair rate of 100%. Echocardiographic examination revealed excellent early postoperative results with no or trace mitral insufficiency in 86.8% and mild in the remaining 13.2% of cases. We failed to find a significant difference between groups with respect to transmitral pressure gradients, MV orifice areas, or mean size of implanted MV rings. Our findings are in contrast with a small retrospective, nonrandomized study by Kudo and colleagues that demonstrated lower gradients early postoperatively in the loop group compared with leaflet resection.15Go With regard to early reverse remodeling, we also failed to demonstrate a significant difference for left atrial size reduction or parameters of LV size or function between groups. Perioperative complications rates were low for both groups of patients. During follow-up, there was no valve-related reoperations and no adverse events in either group.

Before starting the study, we hypothesized that the loop technique would result in more favorable valvular hemodynamics than leaflet resection. However, we were unable to demonstrate a significant benefit of the loop technique over standard leaflet resection with regard to larger annuloplasty sizes, larger MV orifice areas, or lower transmitral gradients.

Our only statistically significant finding was that patients undergoing the loop technique had a longer line of leaflet coaptation than patients undergoing leaflet resection. It has been demonstrated that length of coaptation is an important predictor of MV repair durability in patients with ischemic MR.19Go Although it may be postulated that a longer line of coaptation may also be protective in patients with myxomatous MV disease, longer follow-up will need to be performed to answer this question.

We conclude that both types of MV repair techniques can be performed with excellent early postoperative results in patients with posterior MV prolapse. The loop technique results in more leaflet coaptation but no demonstrable differences in valvular insufficiency or hemodynamics. Although longer term follow-up is required, we believe the loop technique with preservation of native tissue is a valid alternative to posterior leaflet resection. The loop technique may be particularly helpful when MV repair is performed through a minimal invasive thoracotomy.


   Limitations
Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 Limitations
Conclusions
 References
 
The number of patients included in the study may have been too small, and thus the study may have been underpowered to detect subtle differences in clinical outcomes. However, our sample size was probably sufficient to detect differences in our primary outcome—valvular hemodynamics and orifice size—because these outcomes are continuous in nature. Another study limitation is the relatively low proportion of patients who were available for echocardiographic follow-up 1 year postoperatively. Follow-up was limited for 2 reasons: Approximately one half of patients underwent operation within the last year of the study period, and a significant proportion of patients were referred from afar and were unwilling to return to the Heart Center Leipzig, Leipzig, Geramny, for echocardiographic follow-up. It is important to stress, however, that only 13.2% of our patients had mild MR on the predischarge echocardiogram. It is known that recurrent MR tends to recur in patients with moderate or more MR early postoperatively,20Go of which none of our patients had. It is therefore unlikely that accruing a higher proportion of 1 year postoperative echocardiograms would have significantly altered our findings. The important question will be how the long-term durability of these 2 techniques compare, but longer-term follow-up will be required to address this issue.


   Conclusions
Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 Limitations
 Conclusions
References
 
This study showed that the use of PTFE neochordae (loop technique) with preservation of the posterior leaflet compares well with standard leaflet resection for the treatment of posterior MV prolapse in the early postoperative course. Both techniques resulted in good echocardiographic outcomes with low rates of morbidity and mortality. Longer-term follow-up will be required to determine whether the results continue to be comparable over time.


   Footnotes
 
* Volkmar Falk and Joerg Seeburger contributed equally to this article. Back


   References
Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 Limitations
 Conclusions
 References
 

  1. Carpentier A. Cardiac valve surgery—the "French correction". J Thorac Cardiovasc Surg 1983;86:323-337.[Medline]
  2. David TE, Ivanov J, Armstrong S, Christie D, Rakowski H. A comparison of outcomes of mitral valve repair for degenerative disease with posterior, anterior, and bileaflet prolapse. J Thorac Cardiovasc Surg 2005;130:1242-1249.[Abstract/Free Full Text]
  3. Oppell UO, Mohr FW. Chordal replacement for both minimally invasive and conventional mitral valve surgery using premeasured Gore-Tex loops. Ann Thorac Surg 2000;70:2166-2168.[Abstract/Free Full Text]
  4. Dreyfus GD, Corbi P, Rubin S, Aubert S. Posterior leaflet preservation in mitral valve prolapse: a new approach to mitral repair. J Heart Valve Dis 2006;15:528-530.[Medline]
  5. Seeburger J, Kuntze T, Mohr FW. Gore-Tex chordoplasty in degenerative mitral valve repair. Semin Thorac Cardiovasc Surg 2007;19:111-115.[Medline]
  6. Kuntze T, Borger MA, Falk V, et al. Early and mid-term results of mitral valve repair using premeasured Gore-Tex loops ("loop technique"). Eur J Cardiothorac Surg 2008;33:566-572.[Abstract/Free Full Text]
  7. Mohr FW, Falk V, Diegeler A, Walther T, van Son JA, Autschbach R. Minimally invasive port-access mitral valve surgery. J Thorac Cardiovasc Surg 1998;115:567-576.[Abstract/Free Full Text]
  8. Mohr FW, Onnasch JF, Falk V, et al. The evolution of minimally invasive mitral valve surgery: two years experience. Eur J Cardiothorac Surg 1999;15:233-239.[Abstract/Free Full Text]
  9. Chitwood WR, Elbeery JR, Moran JM. Minimally invasive mitral valve repair: using a mini-thoracotomy and transthoracic aortic occlusion. Ann Thorac Surg 1997;63:1477-1479.[Abstract/Free Full Text]
  10. Seeburger J, Borger MA, Falk V, Mohr FW. Gore-Tex loop implantation for mitral valve prolapse: the Leipzig loop technique. Op Tech Thorac Cardiovasc Surg 2008;13:83-90.
  11. Filsoufi F, Carpentier A. Reconstructive surgery in mitral valve disease. Semin Thorac Cardiovasc Surg 2007;19:103-110.[Medline]
  12. Edmunds Jr. LH, Clark RE, Cohn LH, Grunkemeier GL, Miller DC, Weisel RD. Guidelines for reporting morbidity and mortality after cardiac valvular operations. J Thorac Cardiovasc Surg 1996;10:812-816.
  13. Executive summary. Available at: www.sts.org/documents/pdf/ndb/Fall_2007_Executive_Summary.pdf] Accessed April 30, 2008.
  14. Gazoni LM, Fedoruk LM, Kern JA, et al. A simplified approach to degenerative disease: triangular resections of the mitral valve. Ann Thorac Surg 2007;83:1658-1664.[Abstract/Free Full Text]
  15. Sakamoto Y, Hashimoto K, Okuyama H, et al. Long-term assessment of mitral valve reconstruction with resection of the leaflets: triangular and quadrangular resection. Ann Thorac Surg 2005;79:475-479.[Abstract/Free Full Text]
  16. Kudo M, Yozu R, Kokaji K, Iwanaga S. Feasibility of mitral valve repair using the loop technique. Ann Thorac Cardiovasc Surg 2007;13:21-26.[Medline]
  17. David TE, Bos J, Rakowski H. Mitral valve repair by replacement of chordae tendineae with polytetrafluoroethylene sutures. J Thorac Cardiovasc Surg 1991;101:495-501.[Abstract]
  18. Gillinov AM, Cosgrove DM, Lytle BW, et al. Reoperation for failure of mitral valve repair. J Thorac Cardiovasc Surg 1997;113:467-475.[Abstract/Free Full Text]
  19. Kuwahara E, Otsuji Y, Iguro Y, et al. Mechanism of recurrent/persistent ischemic/functional mitral regurgitation in the chronic phase after surgical annuloplasty: importance of augmented posterior leaflet tethering. Circulation 2006;114(1 Suppl):I529-I534.[Medline]
  20. Meyer MA, von Segesser LK, Hurni M, Stumpe F, Eisa K, Ruchat P. Long-term outcome after mitral valve repair: a risk factor analysis. Eur J Cardiothorac Surg 2007;32:301-307.[Abstract/Free Full Text]



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