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ar-Zeh, MDa
a Department of Anesthesiology and Intensive Care Medicine II, Leipzig Heart Center, University of Leipzig, Leipzig, Germany
b Department of Cardiac Surgery, Leipzig Heart Center, University of Leipzig, Leipzig, Germany
d Innovation Center for Computer Assisted Surgery, University of Leipzig, Leipzig, Germany
c TomTec, Munich, Germany
Accepted for publication July 14, 2008.
* Address correspondence to Dr Ender, Department of Anesthesiology and Intensive Care Medicine II, Leipzig Heart Center, University of Leipzig, Struempellstr 39, Leipzig, 04289, Germany (Email: joerg.ender{at}medizin.uni-leipzig.de).
| Abstract |
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Methods: In patients undergoing elective MV repair, a 3D MV reconstruction was performed using TEE. Modified 4D valve assessment software was used to create 3D computer-aided design models of standard annuloplasty rings (28 to 36 mm), which were stored in a digital database. These virtual 3D annuloplasty ring templates were superimposed on the preoperative 3D TEE reconstructions of the MV, and results were compared with conventional sizing under direct vision. A post hoc validation of the 3D models was performed using the implanted rings as a control. The echocardiographer was blinded to the implanted ring size.
Results: The study included 50 patients. The correlation between the selected 3D annuloplasty ring template and the implanted annuloplasty ring size was 0.83. Thirty ring templates (60%) were the same size as the implanted annuloplasty ring, 19 templates (38%) differed by ±2 mm in size, and 1 template differed by +4 mm. Postoperatively, the validation protocol revealed a correlation of 0.94 between the size of the ring templates and the implanted annuloplasty prostheses.
Conclusions: Augmented reality-enhanced TEE for determining optimal annuloplasty ring size during MV repair correlates well with conventional surgical sizing and may facilitate future percutaneous MV repair techniques.
| Introduction |
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Mitral annuloplasty ring sizing is usually performed using commercial sizer models during cardioplegic cardiac arrest on the unloaded and nonbeating heart. Sizing is based on the inter-trigonal distance or the height of the anterior mitral leaflet, with the latter usually being considered the most important criterion. Accurate sizing of the mitral annulus may occasionally be challenging in patients in whom good exposure of the MV is difficult to obtain.
The use of intraoperative transesophageal echocardiography (TEE) is a class I indication to detect the underlying MV pathology and to grade the severity of mitral regurgitation during MV repair [2]. Three-dimensional (3D) reconstruction of TEE images can be used to accurately define all of the components of the MV, including the mitral annulus. The value of echocardiography for determining optimal ring annuloplasty size has been recently reported, and echocardiographic dimensions of the anterior MV leaflet have been shown to correlate well with in vivo sizing [3].
Image-guided selection of the correct prosthetic valve size is already a clinical reality in patients undergoing transapical and transfemoral aortic valve implantation procedures [4]. Percutaneous MV repair procedures are already under clinical investigation, with several new devices in the preclinical stages [5]. Conventional sizing of the MV annulus with surgical exposure and sizing tools will not be possible for such procedures. Although current percutaneous MV repair devices do not require specific sizing of the MV annulus, it is likely that future generations will be tailored to the patient's anatomy.
We therefore investigated the utility of augmented reality techniques to superimpose 3D computer-aided design (CAD) annuloplasty ring models on 3D echo reconstructions of the MV and its annulus, and compared the results with the gold standard of conventional surgical sizing during MV repair.
| Patients and Methods |
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After the induction of anesthesia, a 3D reconstruction of the MV was performed preoperatively using standard TEE equipment (Sonos 5500, Philips, Eindhoven, The Netherlands) and specialized 3D reconstruction software (4D-Valve Assessment, TomTec; Munich, Germany). The reconstruction software automatically created 2D video loops in 5° increments (range, 0° to 180°) in the midesophageal 4-chamber view. These 2D loops were digitally stored, and 3D reconstruction was subsequently performed (Fig 1).
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Because of the asymmetric shapes of both the annulus and the ring model, the orientation of some principal axes of inertia were flipped to get the same relative orientation for both geometries. This was accomplished by some geometric assumptions exploiting the saddle shape of the ring and annulus. Next, the principal axes were sorted by descending eigenvalues, and the annuloplasty ring was rotated to match the ring's axes with those of the mitral annulus. Because the annuloplasty ring cannot lie directly inside the annulus in vivo, the last step was to shift the ring by a small, predetermined distance along its main principle axis toward the center of the left atrium. If the resulting adjustment was unsatisfactory, the Ring Tool offered the opportunity to arbitrarily orient the computerized ring model directly in space or accordingly in any 2D planar reconstruction throughout the ultrasound volume.
A validation protocol was performed at the end of the MV repair, after the annuloplasty ring was implanted. A second 3D reconstruction was performed, and the echo investigator was blinded to the actual size of the implanted ring. The modified 4D-Valve Assessment software was used to determine the size of the annuloplasty ring by superimposing the computerized ring models over the actual implanted ring. The implanted annuloplasty ring was visualized either in a 3D reconstruction (Fig 4) or in three 2D planes that were determined from the 3D model (Fig 5). The size of the selected computerized annuloplasty ring was then compared with the size of the actual implanted annuloplasty ring.
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| Results |
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Successful minimally invasive MV repair with implantation of an annuloplasty ring was performed in all 50 patients. Isolated ring implantation was performed in 4 patients (8%), and the remainder required concomitant MV leaflet or chordal repair, or both. In 40 patients (80%), MV prolapse was corrected by creating artificial chords, whereas 6 patients (12%) required partial leaflet resection.
Operative mortality was 0%, and no strokes occurred. Residual mitral regurgitation after MV repair was none in 33 patients (66%), trivial in 10 (20%), mild in 3 (6%), and mild to moderate in 4 (8%). None of the patients required reoperation for residual mitral regurgitation. All patients were discharged between postoperative day 9 and 12.
The correlation between the suggested ring size from the preoperative 3D reconstruction and the actual implanted annuloplasty ring was 0.83 (p < 0.01; Table 1). The correlation between the implanted ring size and the postoperative ring tool assessment was 0.94 (p < 0.01; Table 2). Image quality was judged to be excellent in 7 patients (14%), good in 30 (60%), and poor in 13 (26%).
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| Comment |
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Different methods of intraoperative annuloplasty ring sizing have been suggested, including measuring the distance between the medial and lateral trigones, assessing the size of the anterior MV leaflet, and simple "eyeballing." Although sizing of the anterior MV leaflet with commercially available sizers is the most commonly used method, it is subject to observer interpretation and may be more difficult for surgeons with limited MV repair experience, particularly if exposure of the MV is suboptimal. Distortion of the mitral annulus during exposure of the MV may also complicate the decision-making process. In addition, conventional ring sizing is performed during nonbeating heart conditions on the cardioplegic, arrested heart, which may be less physiologic than during normal systole and diastole. The mitral annulus is a very dynamic structure, with variations in surface area of 15% to 35% during the cardiac cycle [1].
A mismatch in annular ring sizing may lead to either residual mitral regurgitation if the annuloplasty ring is too large, or mitral stenosis if the ring is too small. Ring oversizing can cause postoperative mitral regurgitation in the early postoperative period if there is decreased leaflet coaptation or in the late postoperative period if the annuloplasty ring dehisces as a result of excessive tension on the fixation sutures. Ring undersizing may also lead to early mitral regurgitation by systolic anterior motion of the anterior leaflet, with subsequent left ventricular outflow tract obstruction. The systolic anterior motion phenomenon tends to occur in patients with a reduced distance between the interventricular septum and leaflet coaptation as well as in patients with a relatively large posterior leaflet [13–15].
Percutaneous (transapical and transfemoral) aortic valve implantation procedures are being performed without conventional sizing of the aortic annulus [4]. Because the valve and annulus are never exposed, image-guided methods are used to determine the correct size of the implanted device. Percutaneous MV repair procedures are already a clinical reality, and several new devices and procedures are in preclinical development [5]. Although device sizing is not yet an issue for leaflet-based procedures, annular-based devices will likely require some tailoring to the patient's MV anatomy. Because conventional surgical sizing is not possible for percutaneous procedures, alternative methods of device size selection will need to be developed.
Intraoperative TEE is known to be invaluable for supplying information on MV leaflet pathology and the mechanisms of mitral regurgitation during MV repairs [16, 17]. Previous investigators have attempted to perform sizing of the mitral annulus using echocardiographic measures only. Cook and colleagues [18] examined annuloplasty ring size selection based on intraoperative TEE in patients undergoing robotic MV repair, where insertion of a conventional annuloplasty-sizing device through a small, port access incision is a challenge [18]. These investigators observed postrepair systolic anterior motion in 3 of 11 patients (27%), leading them to conclude that isolated TEE sizing of the mitral annulus is inadequate. Choo and colleagues [19] attempted to determine the inter-trigonal distance based on measurement of the aortic valve diameter. This technique has not been adopted clinically, however, probably because of variability in aortic annular dimensions in patients with mitral regurgitation.
Although MV repair is the procedure of choice for patients with mitral prolapse, residual or recurrent mitral regurgitation occurs in 0.5% to 1.5% of patients per year [20]. We postulated that the use of reality-enhanced 3D echocardiography may allow surgeons to virtually select an annuloplasty ring size preoperatively and subsequently modify the size if it appears suboptimal during diastolic or systolic left ventricular function. Such a capability may improve ring-sizing techniques and outcomes for MV repair, particularly for surgeons with limited MV repair experience or during unusual cases where visualization of the MV apparatus is a challenge. Virtual sizing may also play an important role in patients undergoing percutaneous or robotic MV repair and may prove to be a valuable tool for resident education and training. We therefore studied the feasibility and reliability of reality-enhanced 3D echocardiographic ring sizing during minimally invasive MV repair.
We investigated modified TEE-guided sizing using computerized ring models that could be superimposed on 3D reconstructions of the mitral annulus. All patients received a Carpentier-Edwards Physio ring in the current study because it is our device of choice for MV repairs. We observed a good correlation between preoperative virtual annular sizing and the size of the actual implanted annuloplasty ring (r = 0.83). In addition, we observed very good correlation (r = 0.94) between the two techniques during our validation protocol, which was performed after annuloplasty ring implantation by an echocardiographer who was blinded to implanted ring size. We believe that the preoperative and validation protocol results provided evidence for the accuracy of the 3D reality-enhanced sizing technique.
The precise agreement of ring sizing by surgical and 3D TEE inspection in 30 of 50 patients may reflect that all MV repairs were performed by experienced surgeons in a high-volume center, where more than 350 MV repairs are performed each year. In 1 patient where the implanted ring size was 4 mm smaller than the TEE-guided ring, a large resection of the posterior mitral leaflet and the anterior mitral leaflet had been performed, leading to substantial undersizing. Some sort of calibration may therefore be required if an extensive leaflet resection is planned. The question of whether a difference of 2 mm in ring size between both methods is clinically important cannot be answered by this retrospective study. Poor image quality in 13 patients may explain some disparities. This problem is most likely to be solved in the near future, however, with the availability of real-time 3D TEE.
We conclude that reality-enhanced 3D TEE ring sizing with the Ring Tool software accurately predicts the size of the annuloplasty ring compared with the gold standard of conventional surgical sizing. The Ring Tool may be particularly helpful for surgeons with limited MV repair experience, for patients in whom exposure of the MV apparatus is very challenging, for surgical education, and for patients undergoing robotic MV repair. In addition, our technique may prove to be very useful in patients undergoing future annular-based percutaneous MV repair procedures.
| Acknowledgments |
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