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Eur J Cardiothorac Surg 2000;17:501-504
© 2000 Elsevier Science NL

The revival of surgical treatment for isolated proximal high grade LAD lesions by minimally invasive coronary artery bypass grafting

^a Department of Cardiac Surgery, Universität Leipzig, Heartcenter, Russenstrasse 19, 04289 Leipzig, Germany
^b Department of Cardiology, University of Leipzig, Heartcenter, Leipzig, Germany

Corresponding author. Tel.: +49-341-865-1421; fax: +49-341-865-1452
e-mail: diea{at}.medizin.uni-leipzig.de

	Abstract

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion References

 
Background: Percutaneous coronary angioplasty (PTCA) and stent implantation have become the first-line intervention for patients with isolated proximal LAD-lesions. Minimally invasive direct coronary artery bypass surgery (MIDCAB) has recently been developed to reduce surgical invasiveness for single LAD revascularization. This study focus on the question whether MIDCAB could be an alternative treatment for isolated proximal LAD lesions. Methods: Starting in 1996, MIDCAB was performed in 618 patients. Angiography was performed before discharge and repeated after 6 months at follow-up examination. In an ongoing randomized trial 150 patients with an indication for treatment of a LAD lesion have been included to compare the mid-term outcome after PTCA (n=79) vs. MIDCAB (n=71). Results: In 618 MIDCAB procedures 30-day mortality was 0.6%, perioperative myocardial infarction rate was 1.6%. The conversion rate to sternotomy was 3.4%. The learning curve was demonstrated by a patency rate of 96.0% in 1997, 98.0% in 1998 and 99.1% in 1999, respectively. At 6 months patency rate was 94.4% in 1997 and 97.0% in 1998. The rate of severe stenosis >75% dropped from 5.4% in 1997 to 3.4% in 1998. The over all rate of reinterventions was 5.6%. The preliminary result of the randomized trial revealed a difference in the number of perioperative adverse events, 11.4% in the MIDCAB group vs. 6.3% in the PTCA group (P<0.05). At 6 months follow-up 88.7% of the MIDCAB patients were free from angina vs. 58.2% of the PTCA patients (P<0.02). Restenosis and a positive stress test was diagnosed in 27.9% of the PTCA patients vs. 8.4% of the MIDCAB patients (P<0.02). Reintervention was necessary in 27.9% of the patients after PTCA vs. 8.4% of the patients after MIDCAB. Conclusion: MIDCAB is a safe and effective but technically demanding procedure. Perioperative adverse events may be expected, but early as well as mid-term patency rate are good. When compared to PTCA, the freedom from angina and the need for additional revascularization procedures after 6 months is statistically better for patients having MIDCAB surgery. Thus, MIDCAB is considered a valuable alternative for isolated proximal high grade LAD lesions.

Key Words: Minimally invasive direct coronary artery bypass surgery • Percutaneous coronary angioplasty

	1. Introduction

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion References

 
In patients with isolated proximal LAD stenosis angioplasty has become the treatment of choice although different trials comparing percutaneous coronary angioplasty (PTCA) and stenting and coronary artery bypass grafting (CABG) have not reached there endpoints yet [1–3]. For the patient PTCA and stenting is appealing given the relative minimal invasiveness of a catheter based intervention. At the same time cardiologists referral practice is biased by the fact that diagnosis and the choice of therapy albeit reimbursement are in the same hands. Minimally invasive coronary artery bypass surgery was introduced a few years ago to reduce the surgical trauma for patients having single LAD lesions [4–6]. MIDCAB combines a limited surgical approach to the heart in combination with the avoidance of cardiopulmonary bypass (CPB). The aim of this study was to revive the controversy about the treatment of choice for an isolated proximal LAD lesion on the basis of a single center, 3-year experience with the minimally invasive direct coronary artery bypass surgery (MIDCAB) approach and the preliminary results of a randomized clinical trial comparing the results of MIDCAB vs. PTCA+stent.

	2. Methods

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion References

 
Minimally invasive coronary bypass grafting was performed from April 1996. Due to the introduction of special devices for local mechanical immobilization of the anterior myocardial wall the procedure was standardized in November 1996 as ‘off-pump’ coronary bypass grafting using a antero-lateral minithoracotomy. Harvesting of the internal thoracic artery (ITA) is performed under direct vision and the anastomosis between ITA and LAD is performed on the beating heart. The techniques of MIDCAB have been described elsewhere [7,8]. The institutional protocol included an postoperative angiogram before discharge as well as a 6-month follow-up visit including a repeat angiographic control. Recently, a prospective randomized clinical trial has been initiated to compare the results of PTCA+stent with MIDCAB. For this trial patient selection was as follows: patients were enrolled for randomization on the diagnosis of an isolated proximal LAD stenosis and an ejection fraction exceeding 35%, provided that they had angina symptoms or silent ischemia. Exclusion criteria were an occluded or diffusely diseased LAD, refractory unstable angina, acute myocardial infarction <48 h and massive obesity in female patients (one patient). A consensus on the feasibility of PTCA and stenting or MIDCAB as possible treatments for the target lesion had to be obtained from the cardiologist and the surgeon. Randomization was performed by chance. The primary end points were any adverse event, peri- and postoperative myocardial infarction, CCS status, and additional revascularization procedures. The proposed number of patients is 100 for each group and the study protocol includes a 5-year follow-up period.

2.1. Statistical analysis
All analyses were made according to the intention-to-treat principle. All tests of significance were two-tailed (Mann–Whitney test). A statistical probability of <0.05 was considered significant.

	3. Results

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion References

 
Six hundred and eighteen patients underwent MIDCAB form November 1996. The demographics are depicted in Table 1). The overall in hospital mortality was 2/618 (0.3%), and 4/618 (0.6%) within the first 6 months of follow-up. The overall rate of perioperative myocardial infarction was 10/618 (1.6%). The conversion rate to sternotomy was 5.4% in 1997, 3.2% in 1998 and 1.7% in 1999 (January–May) as depicted in Table 2. The early patency rate was 238/248 (96%) in 1997, 247/252 (98%) in 1998 and 117/118 (99%) in 1999 (January–May). Angiograms at 6 months follow-up demonstrated graft patency in 204 of 216 (94.4%) of the patients operated in 1997 and in 225/232 (97%) of the patients operated in 1998. Severe stenosis at the anastomotic site was documented after 6 months in 12/216 (5.5%) patients in 1997 and 8/232 (3.4%) in 1998. An early redo due to graft failure was necessary in 10/248 patients in 1997, 4/252 (1.5%) in 1998 and 1/118(0.9%) of patients in 1999 (Table 3. The overall 6-month reintervention rate was 28/498 (5.6%).

Baseline characteristics were not different between the two groups. Regarding the type of lesion (A, B, C) the distribution in the PTCA group was 13, 60 and 26% and in the MIDCAB group 12.5, 65.5 and 22% (not significant). Events during PTCA procedure occurred as follows: myocardial infarction 2.5% (early stent occlusion with the need of reintervention); two retroperitoneal hematomas (no need for surgical intervention); two myocardial infarctions after discharge (de novo stenosis). One patient died after discharge from hospital from a stroke. In the MIDCAB group perioperative adverse events have been as follows: myocardial infarction 2.8% (due to early graft failure with the need for redo-operation). One patient suffered from a stroke on postoperative day 5. Intraoperative conversion to sternotomy was necessary in 4.4% and postoperative chest wall hernia developed 2.8% of the patients. One patient died after discharge from hospital with unknown cause but still being in the 30-day period after surgery. Myocardial infarction and postoperative mortality were not significant between both groups, but the total number of adverse events was 6.3% in the PTCA group vs. 11.4% in the MIDCAB group (P<0.05). At follow-up examination clinical status according to CCS classification was CCS 0 in 59% of the PTCA patients vs. 85% in the MIDCAB group. The mean CCS score was 1.73±1.04 for PTCA vs. 1.19±0.49 for MIDCAB, (P<0.01).

Angiography was performed routinely after 6 months for all patients. Overall patency rate was 100% in the PTCA group vs. 98.6% in the MIDCAB group (not significant). Severe restenosis at the region of angioplasty or at the anastomotic site together with a positive stress test was demonstrated in 24.3% of the patients after PTCA vs. 7.0% in the MIDCAB group (P<0.02). Reintervention was performed in 27.4% after PTCA (one patient underwent surgery, all others had repeat PTCA) vs. 8.4%, (one patient underwent surgery all others PTCA) in the MIDCAB group (P<0.02). All reinterventions were successful.

	4. Discussion

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion References

 
PTCA and stenting is an effective treatment for isolated proximal high grade LAD stenoses. It is well accepted by the patients due to its apparent minimally invasive nature, yielding a short hospital stay and quick recovery. Nevertheless, PTCA is faced with a high rate of restenosis requiring additional revascularization procedures [9].

Minimally invasive direct coronary artery bypass surgery (MICAB) was developed to reduce the surgical trauma while ensuring the proven excellent long-term results of ITA to LAD grafting [10]. Our data demonstrate, that the MIDCAB procedure has been standardized over the last 3 years with constantly improving results. MIDCAB can be considered as a safe procedure providing good early and mid-term results. However, MIDCAB is still a surgical procedure and as such some perioperative adverse events can be expected. From the data of our 3-year experience the learning curve is obvious. The rather high rate of early redo due to graft failure, the rate of conversions to sternotomy, and the mid-term patency rate of the first year of experience were markedly improved over the years. This clearly reflects the technical challenge of the microsurgical vascular anastomosis on a moving target through a limited excess. Although patency rates are now equal to what has been reported for open heart surgery, the quality of the anastomosis may not be expected to be similar as it was performed in a conventional arrested heart technique for every patient [11,12]. Patient selection is therefore important. The outcome is in general more related to the severity of the disease, the anatomy and morphology of the LAD, and the patient's constitution. In a large MIDCAB data base Hubacove et al. [13] could demonstrate that apart from other predictors female patients have an increased perioperative morbidity. This is also true for the quality and patency of the anastomosis and attributable to the difficult exposure of the LAD and the tiny and sometimes short ITA conduit resulting form a more difficult access to the heart in females. Patients have to be informed, that there is a conversion rate to sternotomy reaching 3%. The risk for graft failure or a non-perfect anastomosis is low. Based on our data, a mid-term success of the revascularization without the need for additional interventions can be expected in 94.4%. This exceeds by far the results reported for PTCA and stenting. It is therefore justified to state that MIDCAB should be considered for first choice treatment for single LAD lesions along with PTCA and stenting.

The randomized trial that compares both treatment modalities started in 1997. The preliminary data of this ongoing trial demonstrate a the still high rate of reoccurrence of stenosis at the site of the angioplasty which has been reported by others as well [9]. On the opposite site MIDCAB showed a significant increased number of perioperative adverse events as expected. A number of patients showed minor or moderate, and a few severe stenosis at the anastomotic site. The planimetric measurement we used for both groups in that study to quantify these stenoses may have a different value compared with the usually used semiquantitative analysis. Since all patients in the MIDCAB group having a stenosis <75% by planimetric measurement were symptom free and showed normal stress tests (ECG or nuclear scan) the physiologic impact of these usually very short lacing segments at the heel of the anastomosis is not clear. Compared to the PTCA group, the mid-term results showed that significantly more patients were without angina symptoms reflecting the success of MIDCAB treatment. This was accompanied by significantly smaller number of reinterventions which was 28.5% in the PTCA group. However, these observations have preliminary character as the study is not finished yet. In another recently published randomized study Goy and colleagues [14] compared PTA with conventional ITA grafting to the LAD in a 5-year trial. They could also demonstrate the advantage of the surgical procedure with a lower rate of additional revascularization (9 vs. 38%) myocardial infarction (4 vs. 15%) and cardiac events (14 vs. 44%), whereas the clinical status after 5 years was not different in terms of angina classification and ventricular function.

Patients might be in favor of a catheter-based intervention, avoiding a surgical procedure. But facing the less promising long-term results of PTCA it is the duty of the treating physician to provide full information on all alternative treatment options rather than pointing out the invasiveness of a surgical procedure. These treatment options currently include conventional surgery, MIDCAB surgery and PTCA and stenting. Furthermore, the decision for the treatment of choice should not only include the individual risk profile and the exclusion criteria for the various surgical techniques but also the expected success rate of PTCA in respect to the location and morphology of the LAD lesion. It is the author's opinion that MIDCAB will play an increasing role in the treatment of isolate high grade proximal LAD lesions, since it combines reduced surgical trauma, little operative risk, short hospital stay, and low costs with an improved long-term success of coronary artery revascularization. On the basis of a careful interdisciplinary patient selection the outcome of both treatments may be improved for the benefit of the individual patient.

4.1. Limitations of the presented randomized trial
This trial is ongoing and due to the small numbers of each group it has a relative small statistical power so far. Furthermore, MIDCAB as a new surgical technique is compared with the well established PTCA and stenting technique.

	References

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion References

 

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