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J Thorac Cardiovasc Surg 2003;125:273-282
© 2003 The American Association for Thoracic Surgery
Surgery for Acquired Cardiovascular Disease (ACD) |
From the Department of Cardiovascular and Thoracic Surgery, OLV Clinic, Aalst, Belgium.
Read at the Eighty-second Annual Meeting of The American Association of Thoracic Surgery, Washington DC, May 5-8, 2002.
Received for publication June 4, 2002. Revisions requested Aug 20, 2002; revisions received Sept 9, 2002. Accepted for publication Sept 17, 2002. Address for reprints: Filip P. Casselman, MD, PhD, FETCS, Department of Cardiovascular and Thoracic Surgery, OLV Clinic, Moorselbaan 164, 9300 Aalst, Belgium (E-mail: Filip.Casselman{at}olvz-aalst.be).
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Abstract |
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Introduction |
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1-5 Clinical experience confirmed this feasibility but also pointed out an important learning curve and some technique-related major adverse events. 6 This attenuated the initial enthusiasm of several centers. In 1997, Heartport, Inc, obtained authorization from European regulators for investigational clinical application of its EndoCPB system. This meant the start of our clinical program, and we have since used this technology for a variety of indications. The majority of applications, however, were mitral valve repair procedures. This article analyzes our experience with mitral valve repair using the EndoCPB system.
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Methods |
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All patients were preoperatively fully informed about the technique and were able to choose a standard median sternotomy if that was their preference.
Patients
The mean age of the patients was 60.7 ± 13.1 years (range, 27-84 years), and 62% were male (n = 116). Comorbidity was present in 113 (60.4%) patients and included atrial fibrillation in 40 (21.3%) patients, arterial hypertension in 57 (30.5%) patients, chronic obstructive pulmonary disease in 15 (8%) patients, peripheral vascular disease in 2 (1.1%) patients, and insulin-dependent diabetes in 1 (0.5%) patient. Preoperative New York Heart Association functional class was I in 33 (17.6%) patients, II in 72 (38.5%) patients, III in 67 (35.8%) patients, and IV in 15 (8%) patients. Left ventricular function was normal in 136 (72.7%) patients, mildly impaired in 40 (21.4%) patients, moderately impaired in 8 (4.3%) patients, and severely impaired in 3 (1.6%) patients. The mean preoperative left ventricular end-diastolic diameter was 58.6 ± 7.14 mm (range, 32-79 mm). The mean preoperative left ventricular end-diastolic volume index was 104.3 ± 32 mL/m2 (range, 44-196 mL/m2). The left ventricle was preoperatively not dilated in 54 patients.
Preoperative mitral valve disease is detailed in Table 1. The patient with grade 2+ regurgitation had an associated ASD. The Carpentier classification was used to describe valve dysfunction. 7 The median preoperative degree of mitral valve regurgitation was 4. All procedures were primary and elective interventions. In 2 patients the endoscopic mitral valve repair procedure was part of a hybrid approach. Percutaneous transluminal coronary angioplasty and stenting of the right coronary artery (n = 1) and left anterior descending artery (n = 1) were both performed before the valve procedure.
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Surgical technique
After achievement of general anesthesia, the patient is placed in the supine position, with slight elevation of the right hemithorax. All patients are ventilated with a double-lumen endotracheal tube. A right radial arterial line is inserted. Next, a 14F or 17F DLP cannula (Medtronic DLP, Grand Rapids, Mich) is placed percutaneously by the anesthesiologist through the internal jugular vein into the superior vena cava. This is performed under transesophageal echocardiographic (TEE) guidance.
The right common femoral artery and vein are exposed by using an oblique groin incision. A double pledget U stitch (4-0 polytetrafluoroethylene*) is placed at the anterior side of the common femoral artery, and a double purse-string suture (4-0 polytetrafluoroethylene) is placed at the anterior side of the common femoral vein.
An anterolateral working port of 4 to 6 cm is made in the midportion of the right inframammary groove, usually the fourth intercostal space. A medium soft tissue retractor is inserted, but no other rib retractor is used. A camera port is also made in the fourth intercostal space but at the level of the anterior axillary line. Just before the introduction of the camera, the right lung is deflated. At the beginning of the procedure, a 0° camera is used, which is switched to a 30° downward-looking camera once the left atrium is opened and retracted. A venting port is made in the seventh intercostal space at the level of the anterior axillary line; this port also serves for carbon dioxide insufflation once the left atrium is opened. A left atrial blade retractor is introduced into the right side of the chest through the working port and connected to a 2-mm shaft penetrating the chest wall in the fourth intercostal space, just lateral to the right internal thoracic artery. When the right hemidiaphragm precludes a direct view on the left atrium, a pledget-supported stitch is used to pull the dome down through the seventh intercostal space (Figure 1).
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First, the annuloplasty stitches are placed, starting with the first stitch at the anterolateral commissure. Next, 2 annuloplasty stitches are placed on the anterior leaflet annulus just medial of the anterolateral commissural stitch. Now all remaining annular stitches are placed along the remaining annulus, starting at the anterolateral commissural stitch, over the posterior annulus toward the posteromedial commissure and then the medial portion of the anterior leaflet annulus. All annular stitches are exteriorized through the working port and fixed in suture guides. This maneuver exposes the mitral valve completely.
Now the valve is analyzed according to the Carpentier guidelines. 7 Posterior leaflet mitral valve repair is performed by using the Carpentier techniques (Figure 2). 7 Shafted instruments are introduced in the chest and the left atrium through the working port. The repair is performed with the exclusive aid of video assistance. Knots are thrown extracorporeally and tightened with a knot pusher. Anterior mitral leaflet prolapse is corrected with a small triangular resection 8 or with the creation of new polytetrafluoroethylene chords, 9 depending on the extent of the prolapsing area. Once the repair is completed (Figure 3), the left atrium is closed, leaving the venting suction in place for deairing. In addition, suction is applied to the tip of the endoaortic balloon, and the left lung is inflated before final closure of the left atrium. A bipolar ventricular pacing wire (Bipolar pacing lead; Medtronic France, Fourmiss, France) is placed before unclamping because it is otherwise almost impossible to place. The aorta is unclamped, and reperfusion is allowed. The valve repair is tested under TEE guidance just before termination of CPB. Careful hemostasis is performed after protamine hydrochloride (Roche, Fontenay-sous-Bois, France) administration, and 2 drains are left in situ: 1 intrapericardial and 1 intrathoracic. Both drains are exteriorized through an existing port. The pericardium is approximated, and the working port and groin are closed intracutaneously.
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10 In addition to this information, patients were asked about the amount of pain they experienced at the time of the operation; they were also questioned about how fast they had regained professional or expected activity postoperatively, whether they were pleased with the aesthetic result of the operation, and whether they would prefer this technique again if they were to choose between EndoCPB and standard median sternotomy. The mean patient follow-up was 19 ± 15.2 months (range, 0.2-54.1 months) and was 100% complete. A total of 284 patient-years was available for analysis. The New York Heart Association functional class in 184 survivors at follow-up was class I in 149 patients, class II in 30 patients, and class III in 5 patients. At follow-up, 156 patients were in normal sinus rhythm, 20 were in atrial fibrillation, and 8 had pacemaker rhythm.
Assessment of repair and durability
All patients had immediate intraoperative postrepair TEE to assess the repair. Repair durability was primarily assessed by the incidence of reoperation. In addition, the latest echocardiographic follow-up was analyzed to detect the presence of mitral regurgitation. It was available in 178 of 180 patients who retained their native valves at the time of follow-up. The mean echocardiographic follow-up was 14.9 ± 14.7 months (range, 0.1-53.8 months).
Data analysis
The design of the study was retrospective, and data are expressed as means ± SD. Survival and event-free estimates were determined by means of Kaplan-Meier analysis 11 and expressed as proportions ± SE. Analysis was performed with the Statistica package, Release 5.1 (StatSoft, Tulsa, Okla).
Risk factors for outcome were evaluated by using the Cox proportional hazard models. The first event was used as the outcome. First analyses were performed by using only the risk factor of interest in the Cox univariate model. Because none of the risk factors showed a statistical significance of less or equal to 0.10, no further multivariate Cox regression model could be applied. The potential risk factors entered into the analysis of reoperation are listed in the appendix.
Estimates of the linearized incidence rate with corresponding SEs were obtained by dividing the number of events by the corresponding patient-years of follow-up. The SE was calculated as the square root of the incidence divided by the patient-years of follow-up, assuming a Poisson distribution.
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Results |
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The techniques used to perform mitral valve repair are depicted in Table 2. Associated procedures were performed in 17 patients: tricuspid annuloplasty in 6 (3.2%) patients, atrial arrhythmia ablation in 6 (3.2%) patients, ASD in 3 (1.6%) patients, tricuspid annuloplasty and atrial arrhythmia ablation in 1 (0.5%) patient, and a fibroelastoma of the aortic valve in 1 (0.5%) patient. Mean aortic crossclamp and CPB times were 91.4 ± 23.7 minutes (range, 24-160 minutes) and 131.3 ± 28.0 minutes (range, 74-215 minutes), respectively.
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Postoperative reintervention (through the same operative approach) for suspected bleeding was performed in 19 patients. Reintervention was performed as soon as the chest tube output exceeded 100 mL/h for 3 hours. Consequently, an active bleeding source was found in only 9 instances. In one patient, however, a median sternotomy had to be performed to control the bleeding, which was located at the pacemaker insertion. Other postoperative morbidity is depicted in Table 3. Of note is that there were no neurologic events other than the one in the patient who underwent aortic dissection, no wound infections (neither at the working port nor in the groin), and no deep venous thromboses after femoral vein cannulation.
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Durability of the repair
Reoperation
As stated earlier, there was one early failure of repair requiring reoperation on postoperative day 1. In addition, there were 6 late reoperations at a mean of 13.9 ± 7.1 months after the initial procedure. Causes of reoperation were endocarditis in 4 patients and recurrent mitral valve regurgitation in 2 patients (in one patient reoperation was necessitated by progressive left ventricular dilatation after myocardial infarction). All these patients underwent valve replacement with median sternotomy used as the surgical approach. The patient undergoing early reoperation died on postoperative day 5. No other patient died at reoperation. The freedom from mitral valve reoperation was 99.5% ± 0.5% at 30 days, 97.1% ± 1.4% at 1 year, and 93.3% ± 2.6% at 4 years (Figure 4). The linearized incidence rate was 2.5% ± 0.06% per patient-year. No risk factors for repair failure could be detected univariately. Consequently, a multivariate risk factor analysis could not be performed.
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Other follow-up events
One early death and 2 late deaths occurred. One patient died suddenly on postoperative day 49, and another patient died on postoperative day 497 after a cholecystectomy. Survival was 99.5% ± 0.5%, 98.9% ± 0.8%, and 97.8% ± 1.3% at 30 days, 1 year, and 4 years postoperatively, respectively (Figure 5). The linearized incidence rate for death was 1.0% ± 0.03% per patient-year.
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Patient satisfaction
Procedure-related pain
Of all patients, 93.5% stated they experienced minimal to almost no procedure-related pain. None of the remainder mentioned excessive procedure-related pain.
Postoperative recovery
Of patients, 33.7% were back at work or at routine activity within 4 weeks postoperatively. Another 26.6% were back at this activity level within 8 weeks postoperatively. Patient age did not influence postoperative recovery (P = .14).
Cosmesis
An overwhelming 98.4% of the patients were extremely pleased with the cosmetic result of the procedure. In 41.9% of the patients, the scar was hardly visible any more.
Choose again?
In 92.4% of the patients, the patient would choose the same procedure if he or she was to face the same operation again.
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Discussion |
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12-16
The present series, which includes our initial experience and thus our learning curve, demonstrates that the procedure can be safely performed with good results. The 30-day mortality in this series was 0.5%, a figure comparing favorably with those of some of the major classic mitral valve repair studies 17-19 and with that of another initial experience report. 6 Our learning period did, however, include one aortic dissection. This 0.5% occurrence is lower than the initial experience of Mohr and colleagues 6 but higher compared with that of other groups. 20-22 To avoid this complication, we suggest that our cardiologists inject the right iliac artery at the time of heart catheterization to identify iliac artery stenosis.
The smallest femoral artery cannula available is a 21F cannula. The femoral artery therefore needs to be able to fit this cannula and provide adequate flow, a condition that was not fulfilled in one of our patients. To date, we have been unable to correlate inadequate femoral size to another parameter, such as body surface area. However, in addition to severe peripheral vascular disease, a small femoral artery is clearly a contraindication for the use of the EndoCPB system. Other contraindications include excavated pectus (this condition substantially reduces the anteroposterior diameter of the chest and displaces the heart to the left, both of which preclude direct access to the left atrium), aortic regurgitation of greater than grade 1 (precluding the use of antegrade cardioplegia administration), severely atherosclerotic ascending or descending aorta (which dramatically increases the stroke risk with endovascular manipulation), and dense adhesions in the right hemithorax.
Although others demonstrated a lower blood transfusion ratio in minimally invasive procedures versus standard sternotomy, 23-25 our high reintervention rate, median chest tube output, and transfusion rate do not seem to be so favorable. Introducing this technique in 1997, we were extremely cautious and anticipated a markedly reduced blood loss because of reduced tissue trauma. Therefore, we aggressively took patients back by using the same operative approach but found an active bleeding source in only half of the patients. In all other cases, the right hemithorax was rinsed, and cloths were evacuated. Also, all chest tubes remained in place for 48 hours, even when bleeding had stopped after a few hours postoperatively and chest tube output was just serous fluid. This of course also negatively influenced the total amount of chest tube drainage. On the other hand, we do have a very liberal use of blood products, which is reflected in the low transfusion-free proportion of the study population. In addition, quite a high proportion (19.3%) required correction of coagulation parameters, presumably related to the relatively long pump run. Nevertheless, we changed a few things during the study period to reduce excessive bleeding: the pericardial fat is now resected only if it avoids direct approach to the left atrium, and the pacemaker wire is now always placed on the inferior side of the left ventricle, where the thicker muscle avoids a muscle tear caused by the pacemaker wire.
One might argue that the presented surgical technique is not a totally endoscopic procedure because a working port is made. This 4- to 6-cm incision could be used by the surgeon to directly look inside the chest. This working port, however, is only made to permit instrument handling and introduction of an annuloplasty ring. We only use the soft tissue retractor and never spread the ribs, as is done by some other groups. 25,26 The soft tissue retractor is used to minimize postoperative pain but, at the same time, forces the surgeon to look at the screen, thereby totally relying on video assistance for the entire procedure. We therefore consider the procedure totally endoscopic.
The freedom from mitral valve reoperation in the present series was 93.3% ± 2.5% at 4 years (Figure 4
). This is lower than previously reported in other series of degenerative valve disease, where the same percentage of freedom from mitral valve reoperation is reached at approximately 10 years. 17,18 However, only 3 of the 7 reoperations were due to failed mitral valve repair. The 4 others were due to endocarditis. In fact, the linearized incidence rate for endocarditis was 1.4% ± 0.04%, which is rather high. We do not know why the incidence of endocarditis in the present series was so high, but it definitely influenced our reoperation rate negatively.
Patient satisfaction in the present series was very high. More than 98% of the patients were extremely pleased with the cosmetic result of the procedure. Forty-two percent even stated they could hardly see the scar any more. Also, procedure-related pain was very favorably assessed in greater than 93% of the patient cohort, and no patients reported excessive postoperative pain. Other authors also reported favorable postprocedural pain perceptions, both with the current technique 27 and after other minimally invasive mitral valve surgical techniques. 26,28 In addition, almost 34% of the patients were fully recovered within 4 weeks. Faster recovery of patients undergoing minimally invasive operations versus that of patients undergoing standard sternotomy was demonstrated by Glower and coworkers. 24 In the present series an additional 27% of the patients fully recovered within 8 weeks postoperatively. All these factors undoubtedly contributed to the high patient satisfaction rate. Almost 93% of the patients would prefer the same operative technique if they were to start all over again.
Finally, one might consider endoscopic mitral valve repair by using video assistance, a transition phase toward robotic mitral valve surgery. 29 Although mitral valve repair without the use of a working port has recently been reported, 30 we do not feel the need for such a device in mitral valve surgery. Using the current technique, we are able to repair complex cases and have never felt the absence of voice-controlled devices or extra robot-controlled surgical tools to be a shortcoming.
In conclusion, the present series demonstrates the feasibility, reproducibility, and medium-term durability of the EndoCPB technique for mitral valve repair. The technique provides ample patient satisfaction and is currently our technique of choice for isolated atrioventricular valve disease.
The major limitation of this study is its retrospective nature. Although the general cardiac surgery data are prospectively collected in our database, the more specific procedure-related data were retrospectively collected. However, we hardly encountered missing data, presumably because of our high interest in this procedure.
The retrospective nature of the study might have positively influenced the procedure-related pain sensation because patients were asked about procedure-related pain at the time of follow-up. Because the majority of the patients were very satisfied with the procedure and the cosmetic result, periprocedural pain sensation might have been judged more positively than would have been the case if patients were interviewed immediately postoperatively. This is not the case for the postoperative recovery period because this was checked with specific dates or events for every patient.
A prospective randomized trial would be the best approach to truly evaluate the (positive) effect of this operative technique versus a standard median sternotomy approach. However, this is impossible to realize in our center because patients are specifically referred for the endoscopic technique and therefore unwilling to participate in a randomized trial.
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Appendix |
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Left atrial diameter
Discussion
Dr Delos M. Cosgrove (Cleveland, Ohio). Drs Vanermen and Casselman are to be congratulated on excellent results that they have reported using a small right anterior thoracotomy and endoscopic visualization. Their report demonstrates a very low operative mortality rate and advantages in terms of cosmesis and minimal amounts of pain. However, these have not been achieved without a very significant learning curve, prolongation of aortic crossclamp and cardiopulmonary times, and a 10% incidence of reintervention for bleeding. It is of interest that only two thirds of mitral valve repairs during this period were undertaken in this manner, thus suggesting a limitation in the applicability of this method.
We have experience with this approach and compared it with a limited anterior sternotomy. In a pilot study we were unable to demonstrate clinical advantages when compared with a limited sternotomy. We did, however, note an increased equipment expense of $5000 and significantly longer operating room time.
I have a few questions for the authors. Is this approach applicable to all diseases of the mitral valve? If so, what percentage of all your primary isolated mitral valve operations are performed with these techniques?
Second, what are the cost implications considering the increased equipment costs and presumed longer operating room times?
Finally, would you recommend that this technique be adopted universally as a standard practice for mitral valve surgery?
Dr Vanermen: Thank you very much, Dr Cosgrove, for your questions. Your points are very well taken because I think that is what it is all about when it comes to implementation of new technology. There is a lot of new technology coming up in the 21st century. We should be able to recognize which might be useful and which might not, and that is the first step.
The second step is procedural development. That is the most difficult part, and I can tell you that in this case it was blood, sweat, and tears. Therefore, in the beginning it would have been unwise to adapt this technique to every abnormality of the mitral valve. Not everyone in our team adopted the technique, and we started with the easy cases. At this very moment, we would treat all isolated mitral valve abnormalities this way.
The learning curve was difficult, and I am not predictive enough to say when all mitral valve surgery will be endoscopic. I hope that will be the case one day for the patients. But the learning curve is difficult, and people should not commit the same mistakes and encounter the same obstacles we encountered in the beginning of our experience. At a certain moment beyond the learning curve, this should become a routine operation, and then the teaching commences. We hope that it will be generally used one day.
As far as cost is concerned, there is no evidence thus far that the undoubtedly higher in-hospital cost is compensated for by the absence of procedure-related pain, the absence of scar-related problems, and the faster rehabilitation.
Dr F. W. Mohr (Leipzig, Germany). Dr Vanermen, I would like to congratulate you for your pioneering work. As you well know, we do have our own experience with that procedure in about 600 patients, and we have eliminated the cost concerns from Toby Cosgrove by eliminating the balloon after 200 patients and just using a straightforward crossclamp, transthoracic clamp, which had a significant effect also on neurologic problems.
I just have one question for you, which I think you failed to mention, concerning the advantage of such procedures in redo operations, patients who had previous coronary bypass surgery, and patients who had previous aortic valve replacements. Could you comment on this aspect too?
Dr Vanermen: Your point is very well taken, Dr Mohr. It is true, and this is an extremely valuable technique in all those cases when patients actually had sternotomy or redo sternotomy already and had thoracic grafts in front of their ascending aorta. If you had to go to the mitral valve then, it becomes easy if you apply this endoscopic technique and if you go through a very small right lateral thoracotomy. In those patients the balloon obviously is extremely useful, too. And I can imagine that sometimes you can clamp the aorta with a transthoracic clamp. Through the small incision I have made, it is impossible to actually control the bleeding site on the ascending aorta if something occurs when you withdraw your aortic cannula or when you withdraw your cardioplegic cannula in the ascending aorta.
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Footnotes |
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E. Lapenna, L. Torracca, M. De Bonis, G. La Canna, G. Crescenzi, and O. Alfieri Minimally Invasive Mitral Valve Repair in the Context of Barlow's Disease Ann. Thorac. Surg., May 1, 2005; 79(5): 1496 - 1499. [Abstract] [Full Text] [PDF]
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W. R. Chitwood Jr INVITED COMMENTARY Ann. Thorac. Surg., February 1, 2005; 79(2): 490 - 491. [Full Text] [PDF]
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A. J. Tatooles, P. S. Pappas, P. J. Gordon, and M. S. Slaughter Minimally invasive mitral valve repair using the da Vinci robotic system Ann. Thorac. Surg., June 1, 2004; 77(6): 1978 - 1984. [Abstract] [Full Text] [PDF]
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 S. H. Rahimtoola The year in valvular heart disease J. Am. Coll. Cardiol., February 4, 2004; 43(3): 491 - 504. [Full Text] [PDF]
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F. P. Casselman, S. Van Slycke, F. Wellens, R. De Geest, I. Degrieck, F. Van Praet, Y. Vermeulen, and H. Vanermen Mitral Valve Surgery Can Now Routinely Be Performed Endoscopically Circulation, September 9, 2003; 108(90101): II-48 - 54. [Abstract] [Full Text] [PDF]
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