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Eur J Cardiothorac Surg 2008;33:566-572. doi:10.1016/j.ejcts.2008.01.013
Copyright © 2008, European Association for Cardio-thoracic Surgery. Published by Elsevier. All rights reserved.
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Thomas Kuntze
Michael A. Borger
Volkmar Falk
Evaldas Girdauskas
Nicolas Doll
Thomas Walther
Friedrich Wilhelm Mohr
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Right arrow Minimally invasive surgery
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Early and mid-term results of mitral valve repair using premeasured Gore-Tex loops (‘loop technique’)

Thomas Kuntze*, Michael A. Borger, Volkmar Falk, Joerg Seeburger, Evaldas Girdauskas, Nicolas Doll, Thomas Walther, Friedrich Wilhelm Mohr

Department of Cardiac Surgery, Heart Center Leipzig, University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany

Received 5 September 2007; received in revised form 26 December 2007; accepted 4 January 2008.

* Corresponding author. Tel.: +49 170 935 8334; fax: +49 341 865 1452. (Email: kuntze{at}web.de).


   Abstract
Top
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusion
 Appendix A
 References
 
Objective: Mitral valve (MV) repair with premeasured Gore-Tex loops (the ‘loop technique’) was introduced in 1999. We assessed the early- and mid-term outcomes for the loop technique in patients with MV prolapse. Methods: A total of 632 patients (447 male, 185 female) underwent MV repair with Gore-Tex loops for MV prolapse. A mini-thoracotomy was performed in 522 patients (mean age 58 ± 12.4 years) and 110 patients received a full sternotomy (mean age 66.5 ± 11.9 years). Early postoperative echo was performed in all patients and clinical follow-up was obtained in 95% of patients. Results: Loops were used to correct prolapse of the posterior leaflet in 308 patients, the anterior leaflet in 150 patients, and both leaflets in 174 patients. The mean length of Gore-Tex loops was 20.8 ± 3.4 mm for the A2 segment and 14.3 ± 3.0 mm for the P2 segment. Concomitant procedures consisted of atrial fibrillation ablation in 123 patients, tricuspid valve repair in 30 patients, coronary bypass surgery in 73 patients, and aortic valve surgery in 21 patients. Mean aortic cross-clamp and cardiopulmonary bypass times were 89 ± 32 and 137 ± 43 min, respectively. Predischarge echocardiography revealed no residual mitral regurgitation (MR) in 75%, trace or mild MR in 21% and mild-to-moderate MR in 4% of patients. Thirty-day survival was 98.6%, and one-year survival was 97.1%. Freedom from reoperation was 97.4 ± 1.4%, 3 years postoperatively. Conclusion: MV repair with premeasured Gore-Tex loops results in excellent early- and mid-term outcomes for all types of leaflet prolapse. The loop technique facilitates minimal invasive MV repair without compromising surgical outcomes.

Key Words: Mitral valve repair • Chordae replacement • Gore-Tex loops


   1. Introduction
Top
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 5. Conclusion
 Appendix A
 References
 
Mitral valve (MV) repair has become the procedure of choice for almost every type of mitral regurgitation (MR). Different techniques have been described to correct leaflet pathologies.

Prolapse of the posterior leaflet, the most common type of prolapse, can be treated with leaflet resection with excellent short-term and long-term results. However, the correction of anterior or bileaflet prolapse is more complex and the surgical options are often more difficult to apply. The use of native chords for chordal shortening or transposition, as well as leaflet resection techniques, are complex and limited by the available native valve material. In addition, recent evidence suggests that the pathomechanism of MV prolapse is influenced significantly by disease of the chordae tendinae [1,2].

The construction of anterior leaflet neo-chords using PTFE (Gore-Tex, W.L. Gore & Associates, Flagstaff, AZ) was introduced in 1980s by David et al. [3,4] and Frater et al. [5]. These surgeons used and propagated their techniques for correction of anterior leaflet prolapse and demonstrated excellent early- and long-term results [6,7]. This technique is complicated by difficulties in achieving reproducible neo-chordal length, however, resulting in a lack of widespread adoption by most surgeons. Several techniques have been described to make adjustment of neo-chordal length simpler and more reproducible [8–13]. However, none of these techniques have achieved widespread clinical application.

The introduction of minimally invasive MV surgery has confronted our group and others with the problem of having to adjust the proper chordal length with long knot pushers and instruments through a small incision. We therefore developed a new technique that was first published by Mohr et al. [14] in 2000. This so-called ‘loop technique’ involves pre-manufactured 5/0 Gore-Tex sutures with four loops of identical length that are sutured to the papillary muscles. The ends of the loops are then fixed to the prolapsing leaflet segments. The length of required loops is determined by measuring the appropriate distance from the papillary muscle to the free edge of a nondiseased portion of the MV leaflet using a custom made measuring device. We have used this technique since 1999 in minimally invasive MV repairs and more recently in conventional, full sternotomy MV repairs. We therefore reviewed our early- and mid-term results for the loop technique to determine its safety, efficacy and durability in patients with MV prolapse.


   2. Methods
Top
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 5. Conclusion
 Appendix A
 References
 
We reviewed data of all patients who underwent MV repair for mitral prolapse, using the loop technique, at our institution from January 1999 to February 2007 (n = 632). The majority of patients underwent minimal invasive MV repair through a right mini-thoracotomy (n = 522), while a smaller proportion was operated on via a sternotomy (n = 110). The minimally invasive technique was performed via a right anterolateral mini-thoracotomy, 5–8 cm in length. Additional small (5–10 mm) ports were used for video assistance, a left atrial retractor, and a transthoracic aortic clamp. The minimally invasive technique is our standard approach for isolated MV surgery, or for MV surgery in combination with tricuspid valve repair, atrial fibrillation ablation procedures, and/or closure of atrial septal defects. Full sternotomy was chosen in the presence of comorbidities that required operative procedures that could not be performed through a minimally invasive approach (e.g. aortic valve replacement, coronary bypass surgery).

Perioperative management was the same for all patients. Cardiopulmonary bypass (CPB) flow rates were maintained between 2.0 and 2.5 l/min/m2 and mean arterial pressure was kept above 70 mmHg in patients with renal insufficiency or peripheral vascular disease. Hematocrit was kept above 20% and mild hypothermia (32–34 °C) was employed during CPB. Myocardial protection consisted of either antegrade Bretschneider crystalloid cardioplegia for all minimally invasive procedures, or antegrade crystalloid or cold oxygenated blood mixed with crystalloid in 4:1 ratio for all sternotomy procedures.

2.1 Loop technique
The implantation technique of Gore-Tex loops has been previously described [14,15]. Briefly, a custom made calliper (Geister Inc., Tuttlingen, Germany) is used to assess the correct length of the PTFE-loops after exposure of the MV and subvalvular apparatus. The distance between the tip of the papillary muscle and the edge of a non-prolapsing segment (usually P1) is used to determine the correct loop length. We prefer using shorter loops than measured for large P2-segments to avoid systolic anterior motion (SAM). The loops for the anterior segments are selected exactly as determined with the calliper to allow for good leaflet coaptation. Transesophageal echocardiography has also proven helpful to estimate the required length of neo-chordae and to assess the quality of repair after correction.

Our loops are manufactured in-house by a dedicated individual using a single 5/0 Gore-Tex suture. As can be seen in Fig. 1 , there is a central pledget with four single loops ranging from 10 to 26 mm in length (see Ref. [15] for more illustrations). The needles of the sutures originating from the pledget are then passed through the tip of the respective papillary muscle and tied over a second pledget. The free loops are fixed to the prolapsing leaflet segment using additional 5/0 Gore-Tex sutures, placing the knot on the ventricular surface of the leaflet whenever possible.


Figure 1
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  		Fig. 1. Premeasured Gore-Tex loops.

 
2.2 Echo
All patients underwent intraoperative transesophageal echocardiography to determine the mechanism of the MR, to estimate the required length of Gore-Tex loops, and to assess the quality of the MV repair at the end of CPB. All patients also underwent pre-discharge transthoracic echocardiography to assess the quality of the repair and to grade postoperative MR. MR was determined according to published guidelines [16] and was graded on a scale of 0–4 where 0: none, 1: trivial-to-mild, 2: moderate, 3: moderate-to-severe, and 4: severe.

2.3 Data source
Data were gathered on all patients including pre-, intra-, and postoperative variables, and were entered into our computerized database. Preoperative variables and adverse outcomes were confirmed by a database manager and a team of study assistants. Follow-up was performed by telephone and/or mail questionnaire with patients and/or their families, with supplemental information supplied from family physicians and referring cardiologists. Follow-up was obtained in 95% of patients at an average of 18 ± 15 months postoperatively.

2.4 Statistical analysis
Categorical data are expressed as percentages and continuous data as mean ± standard deviation throughout the manuscript. Categorical data were compared between groups with chi-square or Fisher's exact test where appropriate, and continuous data were compared with unpaired t-tests or Wilcoxon rank sum tests where appropriate. Long-term and reoperation-free survival was assessed with the methods of Kaplan–Meier. SPSS version 14.0.1 (SPSS Inc.) and SAS version 8.2 (SAS Institute; Cary, NC) were used for all statistical analyses.


   3. Results
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 5. Conclusion
 Appendix A
 References
 
Table 1 shows the demographic data and preoperative characteristics for all patients. The data is also split into groups of patients undergoing MV repair through a minimally invasive approach compared to those operated on via conventional sternotomy. Left ventricular function was normal in the majority of patients in both groups. The sternotomy group had a higher prevalence of previous cardiac surgery, coronary artery disease, aortic valve disease, chronic obstructive pulmonary disease, and renal insufficiency.


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  		Table 1 Preoperative patient characteristics
 
Table 2 shows the operative data and procedures performed in all patients. Half of all patients received loops to the posterior leaflet only, independent of the surgical approach. In the minimal invasive group, one-third of patients received loops to both leaflets while a greater fraction of sternotomy patients received loops only to the anterior leaflet. All patients received an additional annuloplasty ring with a mean size of 32.6 ± 3.3 mm. Associated procedures on the MV consisted of leaflet resection, commissural plication, decalcification, and Alfieri valvuloplasty. Mean cardiopulmonary bypass time was 137 ± 43 min and mean cross-clamp time was 89 ± 32 min for all patients. The times for the sternotomy group were longer due to the larger number of concomitant procedures.


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  		Table 2 Operative data including technical details and additional procedures
 
Table 3 shows the details for the chordal replacement procedure. The loop length for the posterior leaflet was on average 2/3 of the length as for the anterior leaflet.


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  		Table 3 Number and length of loops used for chordal replacement.
 
Fig. 2 shows pre- and postoperative severity of MR, as graded by transthoracic echocardiography. Preoperative MR was at least moderate in 625 patients (99%). Mild or less MR was present in 96% of patients on predischarge echo.


Figure 2
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  		Fig. 2. Echocardiography: mitral regurgitation (MR) preoperatively and postoperatively.

 
Table 4 summarizes postoperative complications for the entire cohort. A total of 11 patients (1.7%) required early cardiac reoperation: four operations for occlusion of the circumflex artery, three re-MV repairs, three MV replacements for recurrent MR, and one aortic valve repair. Thirteen patients required new postoperative dialysis. A single patient required extra-corporeal membrane oxygenation following occlusion of the circumflex artery with associated myocardial infarction. There were four reoperations beyond 90 days postoperatively, consisting of three MV replacements and one re-MV repair. There were no significant differences between the two surgical approaches for any of the complications listed.


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  		Table 4 Reoperations and complications
 
Table 5 and Fig. 3 show medium-term survival and reoperation-free rates. Given that there has been a steep increase in the number of patients operated on using the loop technique in the past 3 years at our institution, there were a relatively small number of patients available for longer-term follow-up. Fig. 3 shows the Kaplan–Meier survival curve for all patients. Actuarial survival at 6 years was 86.2 ± 11.8% (95% confidence interval).


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  		Table 5 Survival and reoperation-free rate of patients after chordal replacement
 

Figure 3
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  		Fig. 3. Actuarial survival and freedom from reoperation for all patients (n = 632).

 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
5. Conclusion
 Appendix A
 References
 
Mitral repair techniques for posterior MV prolapse consist mostly of triangular or quadrangular leaflet resection and are associated with excellent perioperative and long-term outcomes [17,18]. However, anterior MV prolapse is more difficult to repair and may result in higher MR recurrence rates [19]. A variety of techniques have been described to correct anterior MV prolapse including chordal shortening, chordal transfer, leaflet resection or plication, and neo-chordae formation with PTFE (Gore-Tex). Chordal shortening and leaflet resection/plication have been abandoned by most centers because of unsatisfactory rates of recurrent MR [20]. Although chordal transfer and neo-chordae formation have been performed with very good results, these techniques have other disadvantages [21,22]. Chordal transfer is limited by the availability of unaffected native chordal tissue, while neo-chordae formation is limited by technical complexity.

The primary problem with neo-chordae replacement for anterior MV prolapse is determining the appropriate length for the Gore-Tex sutures, which can be particularly challenging through a minimally invasive technique. We, therefore, developed the loop technique as a method to facilitate and standardize neo-chordae construction. Although we originally developed this technique for anterior leaflet prolapse, we have also applied it to posterior and bileaflet prolapse and, more recently, to MV repair through a conventional full sternotomy. We have acquired a significant clinical experience with this technique over the last few years, having performed it in over 600 patients. We, therefore, examined our results for MV repair for prolapse using premeasured Gore-Tex loops to assess the safety, efficacy and durability of the loop technique.

David et al. [17] reviewed their experience with MV repair in 2005. A total of 342 patients underwent anterior Gore-Tex neo-chordae replacement for either isolated anterior leaflet or bileaflet prolapse. The freedom from reoperation was 88% for isolated anterior prolapse and 94% for bileaflet prolapse 12 years postoperatively. The authors concluded that Gore-Tex neo-chordae formation was effective and resulted in very good long-term results. Kobayashi et al. [7] reviewed their experience in 74 patients undergoing Gore-Tex chordal replacement for anterior prolapse. Histological analysis of two reoperated patients revealed thickening and stiffening of Gore-Tex neo-chordae, along with protein infiltration into the inner layers of the suture material. These findings led the authors to switch from 4/0 Gore-Tex sutures to 5/0, as well as to limit the total number of neo-chordae implanted. We have used 5/0 Gore-Tex for the loop technique since its inception.

Some principles should be observed during any neo-chordae construction procedure including precise measurement of the required chordal length, secure anchoring of the proximal end of the Gore-Tex suture to the papillary muscle, and attachment of the distal end at the level of the annulus. Our PTFE-loops are manufactured in 2 mm increments in size ranging from 10 to 26 mm in length. The use of PTFE avoids damage of the leaflet tissue, which has been observed with other suture materials [23].

The current study reveals that the loop technique results in outcomes that are comparable to conventional MV repair techniques such as posterior leaflet resection, chordal transfer, and conventional anterior leaflet Gore-Tex neo-chordae formation. Our perioperative outcomes were very good with a 30-day mortality rate of only 1.4%, despite the fact that approximately one-quarter of patients underwent concomitant procedures including aortic valve replacement, tricuspid valve repair, coronary bypass surgery and/or ascending aortic surgery. In addition, the early echocardiographic results were very satisfactory with 75% of patients having no residual MR and 21% having trivial or mild MR prior to discharge. These results compare favorably to a study by Flameng et al. [24], who reported freedom from non-trivial degrees of regurgitation of 94.3% in 242 patients early after mitral valve repair.

Medium-term follow-up in the current study revealed a low MV reoperation rate, occurring in only 10 patients (1.6% of the entire cohort). Six of these MV reoperations occurred in the early perioperative phase after echocardiography revealed significant MV dysfunction, and four occurred during follow-up due to recurrent MR. Although the length of follow-up in the current series is relatively short (mean 18 months), the MV reoperation-free rate of 97% 3 years postoperatively is low and compares favorably to other series [17,25]. Our results have led us to conclude that the loop technique is safe, effective and durable, at least in the medium-term.

One possible disadvantage of the loop technique is the fact that the diseased portions of the MV leaflets are left in place and not resected. It is possible that degeneration of the remaining portions of the MV could occur more quickly in the presence of retained diseased leaflet tissue. However, it should be stressed that the current gold standards for repair of anterior leaflet prolapse, i.e. conventional neo-chordae formation or chordal transfer, also involve retention of diseased portions of the leaflet. Anterior leaflet resection for prolapse has long been abandoned by most cardiac surgery centers, and yet the current results for repair of anterior leaflet prolapse are excellent [17]. It remains to be seen if our technique of retaining diseased leaflet tissue in both the anterior and posterior leaflets will adversely affect the durability of this operation. However, we currently have more than 5-years follow-up in 18 patients and the results in these patients continue to be excellent. Although we do not expect the durability of the loop technique to deteriorate over time, it is important that we continue to closely follow these patients. We will therefore continue to perform regular reporting of our results.

4.1 Study limitations
The primary limitation of our study is the relatively short follow-up time. Although the mean follow-up was only 18 months, the longest duration of follow-up was more than 7 years. We developed the loop technique in 1999, but it was not until 2002 that we became sufficiently comfortable to apply it in the majority patients undergoing MV repair for prolapse. In addition, we have observed a marked increase in the number of patients being referred to our center for MV repair since 2004. These two factors result in the relatively short mean follow-up time. It remains to be seen if the loop technique is as durable as conventional MV prolapse repair techniques, and further follow-up is therefore required. However, our experience in the few patients with relatively long follow-up would suggest that the loop technique is indeed a durable operation.

The other major limitation of our study is its retrospective design, with all of the inherent limitations thereof. We are therefore undertaking a randomized clinical trial comparing the loop technique to conventional leaflet resection during MV repair. We expect to have the results from this study available in the near future.


   5. Conclusion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusion
Appendix A
 References
 
MV repair for prolapse using premeasured Gore-Tex loops results in excellent early- and mid-term outcomes for all types of MV leaflet prolapse. The loop technique facilitates minimally invasive MV repair without compromising surgical outcomes. The long-term durability of the loop technique remains to be seen, but our preliminary findings suggest that it is a safe, effective and durable operation.


   Appendix A
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusion
 Appendix A
References
 
Conference discussion

Mr C. Choong (Cambridge, United Kingdom): This is an important contribution to mitral valve surgery for a number of reasons. Firstly, it is very innovative, secondly, it appears to be reproducible in this very large series, and thirdly, the results are excellent. I have a number of questions.

Firstly, in your manuscript you have stated that the mean follow-up time was 18 months. It is my impression that this series is dealing with early term results rather than mid-term results. Can you tell us what was the medium follow-up time for your group of patients?

Secondly, 26% of your patients had a partial annuloplasty ring and the remaining patients had a complete annuloplasty ring. Can you elaborate on the decision-making regarding these differences?

Thirdly, following surgery, within 90 days, three patients underwent redo mitral valve repair and three other patients underwent mitral valve replacement. There were also four other patients who required redo mitral valve surgery 90 days after the initial operation. Can you elaborate more on the mechanisms of failure, and were there any learning lessons from these redo patients regarding the loop technique?

Fourthly, in this series you have only shared with us those patients who had successful initial mitral valve repair operations. Can you tell us how many patients had undergone mitral valve surgery with the intention to repair however ended up with a replacement intraoperatively? What were the reasons for not being able to repair these valves using the loop technique? Along these lines, is there any particular type of mitral regurgitation that is not suitable for the loop technique?

Fifthly, some of the patients as shown in your slides are still having mitral valve repair by resectional technique. Can you elaborate why these patients are having resectional repair instead of the loop technique?

In your series, all your patients underwent preoperative echo, intraoperative echo and another echo before discharge. Do you have any echocardiographic data following discharge?

My final question is, in your presentation, a few patients with grade 1 or grade 2 mitral regurgitation underwent mitral valve repair. What were the indications for mitral valve repair in these patients who only had grade 1 or grade 2 mitral regurgitation?

Dr Kuntze: Regarding the question concerning the period of follow-up, I agree with you that we are presenting early and mid-term results and that our series should not be interpreted as long-term results. The median follow-up was 15 months. I must stress, however, that our longest follow-up was more than seven years and these patients still have an excellent result, and follow up is complete for more than 95% of our patients. Most of the patients were operated on in the last two or three years, therefore the mean and median follow-up time of this cohort is relatively short. We will continue to follow our patients very closely and hope to present to you the long-term results in the future.

The second question, regarding ring annuloplasty: Approximately one quarter of our patients received partial rings, and this decision was at the discretion of the implanting surgeon. In general we prefer partial rings for P2 prolapse only, and in cases of bileaflet prolapse or ischemic mitral regurgitation we would prefer a complete ring.

Concerning reoperations, there were six patients that required early redo mitral valve surgery and four patients needed late mitral valve reoperations because of a variety of technical problems. This included inappropriate ring selection, ring dehiscence, or stenosis. One reoperated patient had a severe SAM phenomenon and one patient had a ruptured loop due to a polypropylene fixation suture. That is why we currently only use 5-0 Gore-Tex sutures for the fixation of the loops onto the leaflet. We should stress, that 10 patients requiring mitral valve reoperations out of a total series sample size of 632 patients represents very respectable outcomes that compare very well with the literature.

The fourth question concerned the successful mitral valve repair operations. It is true that we did not present those patients who were converted to a mitral valve replacement. We record this information in our database and the rate of conversion to mitral valve replacement is less than 2%. In addition, Dr Seeburger has presented our results for all patients, and the rate of mitral valve repair in patients with mitral insufficiency was more than 87%.

Dr R. Dion (Genk, Belgium): I just have a short technical comment. We are also very aggressive in mitral valve repair, and we regularly use Gore-Tex chordae. I have some problem with predetermining the length of all the neo-chordae. In the vast majority of the cases one can indeed adjust the length of the neo-chordae to that of the adjacent healthy chordae or even measure it before the operation on the echo. But in about 10–15% of the cases one can have a satisfactory watertest before implantation of the annuloplasty ring but some (local) restriction after implantation of the ring. Therefore, I prefer a technique which allows to adjust the length of each neo-chord until after implanting the ring. If one doesn’t, one may see on the postoperative echo some leaflet restriction, not necessarily inducing immediate residual mitral regurgitation but precluding an optimal coaptation length (6–8 mm) which is essential for a stable long-term result. Could you comment?

Dr Kuntze: The first very important step for us is to look at the echo and we can estimate the length of the chords prior to surgery, and as I mentioned, for large P2 prolapse with excess tissue we use shorter loops.

Dr Dion: In our experience, the implantation of a complete ring may induce some restriction of the anterior leaflet on the watertest. Therefore, if one uses premeasured Gore-Tex loops, one may end up with some restriction. I have seen that in about 10–15% of the cases, and that is why I am reluctant to use the Gore-Tex loops.

Dr Kuntze: We have rarely seen this, since we tend to use longer loops for the anterior leaflet.

Dr O. Alfieri (Milan Italy): I would like to ask you whether you observed an increased incidence of postoperative SAM when you use this technique for posterior leaflet prolapse. If not, what precautions do you take for that? Since you never reduce the height of the posterior leaflet I would expect an increase in postoperative SAM.

Dr Kuntze: Sometimes we do reduce the height of the posterior leaflet through resection. However, here I only presented our results with the loop technique. In a few patients with a very large P2 segment we decided to resect, and we have some patients where we have used a combination of both techniques. After resection we also sometimes use loops to improve coaptation of the leaflets.

Dr Alfieri: So you used resection together with this technique?

Dr Kuntze: Sometimes we apply resection, but more importantly we use short loops to correct for excess P2 tissue to avoid SAM.


   Footnotes
 
{star} Presented at the 21st Annual Meeting of the European Association for Cardio-thoracic Surgery, Geneva, Switzerland, September 16–19, 2007.


   References
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusion
 Appendix A
 References
 

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