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Ann Thorac Surg 1999;68:1502-1505
© 1999 The Society of Thoracic Surgeons
Cardiovascular Institute, University of Dresden, Dresden, Germany
Address reprint requests to Dr Schüler, Cardiovascular Institute, University Hospital Dresden, Fetscherstrasse 76, D-01307 Dresden, Germany
e-mail: hkz{at}rcs.urz.tu-dresden.de
Presented at Evolving Techniques and Technologies in Minimally Invasive Cardiac Surgery, San Antonio, TX, Jan 2223, 1999.
Abstract
Background. In a prospective clinical trial, a group of patients receiving less invasive surgical procedure, including minithoracotomy in combination with cardiopulmonary bypass (group 1), was compared to a group of patients receiving conventional bypass surgery (group 2) for the treatment of coronary artery disease.
Methods. Group 1 included 85 patients (71 men, 14 women, aged 39 to 82 years, median 61.1 ± 9.0 years); group 2 included 53 patients (38 men, 15 women, aged 51 to 79 years, median 62.0 ± 6.1 years).
Results. There were no perioperative deaths in the whole series of patients. Time of operation was 256 ± 43 minutes in group 1 and 150.0 ± 53.6 minutes in group 2. Hospitalization was 6.0 ± 1.4 days and intensive care unit stay 1 day for both groups. Back pain assessment on postoperative day 3 showed less pain in group 1. Three-month follow-up revealed ischemia in stress electrocardiogram in 2 patients (2.5%) in group 1 and in 2 patients (4.1%) in group 2. Coronary angiograms confirmed the stress-electrocardiogram findings.
Conclusions. Surgical results are equal for both techniques. Even though time of operation is longer in patients receiving less invasive procedures, intensive care unit stay and hospital stays are the same length. Early postoperative back pain is less in group 1 and combined with faster convalescence.
New goals have been added since 1994 in the surgical treatment of coronary artery disease (CAD). Cardiac surgeons have tried to reduce surgical trauma, sometimes avoiding median sternotomy (MS), sometimes avoiding cardiopulmonary bypass, and even sometimes avoiding both [13]. After gaining experience with the Port-Access (Heartport Inc, Redwood City, CA) system [4], the Dresden group proposed a new approach: avoiding median sternotomy, even in complex cases of CAD, by performing coronary bypass surgery with the help of cardiopulmonary bypass (CPB) [5]. The aim was to reduce surgical trauma and avoid sternotomy-related complications [68]. This so-called "Dresden technique" (DT) enables, in its most recent version, CPB institution without dissection of the groin, which is associated with wound-healing complications, and what is more important, avoiding femoral cannulation of the arterial system, which is associated with severe intraoperative complications such as retrograde aortic dissection [9]. Even if the first 25 patients had an uneventful clinical course without severe complications, despite the extended length of operation, a prospective, nonrandomized clinical trial was started. The trial compares this novel technique with conventional coronary artery bypass surgery, in order to define the benefit provided by this less invasive operation.
Patients and methods
All patients had preoperative assessment of the ascending aorta by transthoracic echocardiography to exclude those with heavily calcified ascending aortas. Body mass index of more than 30 and severely impaired left ventricular ejection fraction less than 30% were further exclusion criteria during the initial phase.
Preoperative patient data and operation
Dresden technique (group 1)
A total of 85 patients with CAD were evaluated for DT surgery. Of these, 40 patients (47%) suffered from single-vessel CAD, but 19 patients (22%) among them were referred for double-bypass surgery because diagonal branches of the left anterior descending coronary artery (LAD) were involved with stenotic lesions as well. In the same group, 32 patients (38%) had double-vessel CAD, and 13 (15%) had triple-vessel CAD. The pattern of coronary lesions is listed in Table 1. Twenty-four (28%) patients had previous percutaneous transluminal angioplasties. Age ranged from 39 to 82 years (median 61.0 ± 9.0 years); 71 men and 14 women. The preoperative left ventricle ejection fraction (LVEF) ranged from 38% to 90% (median 69 ± 12.8%). Fifty-two patients had a previous myocardial infarction and 2 (2.4%) claimed to have unstable angina. Clinical classification revealed that 12 patients (14%) were in Canadian Cardiovascular Society (CCS) stage 1, 44 patients (52%) were in CCS stage 2, 27 (32%) were in CCS stage 3, and 2 patients (2.4%) were in CCS stage 4. A total of 33 patients (39%) were in New York Heart Association (NYHA) class I, 40 patients (47%) were in class II, 11 patients (13%) were in class 3, and 0 patients (0%) were in class IV. Five patients (5.8%) suffered from chronic atrial fibrillation and the values of hematocrit (Hk) and hemoglobin (Hb) were 43.0 ± 5.1% (median ± SEM) and 9.1 ± 4.6 mmol/L (median ± SEM), respectively. Institutional Review Board approval was obtained and informed consent was given by all patients.
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Before removing the aortic clamp, antegrade air removal was performed through the ascending aorta. Proximal anastomoses were performed using a conventional side-biting clamp. The patient was weaned from CPB and cannulas were removed from the aorta and the femoral vein. The sternal edges of the third and fourth rib were attached to the sternum using two steel wires and both ribs were approximated to each other using a 1-mm strong suture (Poly-p-dioxanon, Johnson & Johnson, Hamburg, Germany). Two chest tubes were left in place and the chest incision was closed in layers.
Conventional technique (group 2)
. A total of 53 patients with CAD were evaluated for conventional operation. Of these, 12 patients (23%) suffered from single-vessel CAD, but 5 (9.4%) among them were referred for double-bypass operation because diagonal branches of the LAD were involved with stenotic lesions as well. In the same group, 29 patients (55%) had double-vessel CAD and 12 (23%) had a triple-vessel CAD. The pattern of coronary lesions is listed in Table 1. Seven (13.2%) patients had previous percutaneous transluminal angioplasties. Age ranged from 51 to 79 years (median 62 ± 6,1 years); 38 men and 15 women. The preoperative left ventricle ejection fraction (LVEF) ranged from 42% to 92% (median 67.5% ± 16.1%). A total of 27 patients (51%) had passed a myocardial infarction and 2 (3.8%) of them claimed to have unstable angina. Further, 2 patients (3.8%) were in CCS stage 1, 20 patients (37.7%) were in CCS stage 2, 27 (51%) were in CCS stage 3, and 4 (7.5%) were in CCS stage 4. A total of 10 patients (19%) were NYHA class I, 20 (37.7%) were in class II, 22 (41.5%) were in class 3, and 1 (1.8%) was in class IV. Two patients suffered from chronic atrial fibrillation and the values of Hk and Hb were 43.3 ± 3.2% (median ± standard error of the mean (SEM)) and 9.1 ± 0.7 mmol/L (median ± SEM), respectively.
At operation, the group 2 patients were placed in supine position, receiving the same anesthesia as did group 1 patients. A median sternotomy was performed and a conventional LIMA takedown retractor was used to harvest the LIMA as a pedicle using diathermy and ligating clips from the first to the sixth rib. The pericardium was opened longitudinally and, after cannulation of the ascending aorta and of the right atrium, CPB was started. Coronary vessel anastomoses were performed using cardioplegic arrest in hypothermia. The rest of the procedure was performed in a standard fashion.
Monitoring
Perioperative data included total duration of operation, LIMA harvesting time, duration of CPB, postoperative ventilation, intensive care unit (ICU) stay, and hospitalization. Cardiac enzymes (CK/CKMB) were measured preoperatively and again at 6 hours and then 2 days after surgery. Total volume of bleeding and the number of blood units transfused were monitored in addition to Hb and Hk values during operative and postoperative day 1. The patients had a complete follow-up including physical examination, 12-lead electrocardiogram (ECG), and roentgenogram on postoperative day 2, 14, and 12 weeks. Wound and back pain assessments were performed on postoperative day 3. Three-month follow-up included ECG, NYHA and CCS classification, and stress ECG.
Results
All patients of both groups survived the procedures. They are alive and well 12 months postoperatively. There were no quantitative or qualitative differences between the cardioplegic solutions of the two groups. There was no perioperative infarction. All patients were weaned from CPB in sinus rhythm, without signs of ischemia or necessity for inotropic support. Seventy-nine patients (93%) in group 1 and 49 patients (92%) in group 2 had a complete 3-month follow-up.
In the group receiving less invasive surgery (group 1), left internal mammary artery bypass for LAD (and, if needed, vein grafts to other coronary arteries) were performed in all patients except 1. In this elderly woman, a vein graft was anastomosed to the LAD. The pattern of the coronary vessels grafted and the conduits used are listed in Table 1. After having started the procedure by minithoracotomy in 1 patient, we converted to median sternotomy, due to an undiagnosed, heavily calcified ascending aorta. This patient received conventional bypass surgery and had an uneventful postoperative course.
In the patient group receiving conventional procedures (group 2), LIMA bypass to the LAD (and, if needed, vein grafts to other coronary arteries) were performed in all patients except 6. Out of these 6 patients, 1 patient was referred for surgery due to a lesion of the strong diagonal branch. One patient had no available arterial conduits and 4 patients were referred for surgery with the LAD not being amenable to surgery. One patient (1.9%) in group 2 required re-exploration due to bleeding.
Bleeding volume at 8 and 24 hours after surgery was 250.0 ±178.0 mL (median ± SEM) and 480.0 ± 248.8 mL (median ± SEM) for group 1 and 500.0 ± 276.0 mL (median ± SEM) and 760.0 ± 395.0 mL (median ± SEM) for group 2, respectively (p
0.001, Mann-Whitney U Test). Four hours postoperatively, Hk and Hb were 33.3% ± 6.6% (median ± SEM) and 7.1 ± 4.2 mmol/L (median ± SEM) for group 1 and 31.7 ± 6.4% (median ± SEM) and 6.7 ± 4.0 mmol/L (median ± SEM) respectively (p
0.05, Mann-Whitney U Test). Twenty-five patients (29.4%) in group 1 and 24 patients (45.3%) in group 2 required blood transfusion (p
0.05, Mann-Whitney U Test). Duration of operation, duration of LIMA harvesting, CPB time, cross-clamping time, ventilation, ICU stay, and hospitalization of both procedures are listed in Table 2.
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In group 1 clinical classification at the 3-month follow-up revealed 74 patients (91.3%) in CCS stage 1, 5 patients (6.2%) in stage 2, and 2 patients (2.5%) in stage 3. Forty-four patients (88%) of group 2 were at CCS stage 1, 5 patients (10%) were at stage 2, and 1 patient (2%) was at stage 3. Fifty patients (61.7%) of group 1 were at NYHA class 1, 29 patients (35.8%) were at class 2, and 2 patients (2.5%) were at class 3. Thirty-three patients (66%) of group 2 were at NYHA class 1, 15 patients (30%) were at class 2, and 2 (4%) were at class 3.
At time of discharge from hospital, no patient in either group showed any kind of arrhythmia that was not known before operation. However, 1 patient (1.2%) of group 1 and 2 patients from group 2 (3.8%) were discharged with newly apparent T-wave negativations. At three-months follow-up, 1 additional patient from group 1 had alterations in the myocardial repolarization phase. However, no enzymatic changes were noted. CKMB/CK fraction was normal in both groups.
The 2 patients in each group with ischemic signs in ECG had also a pathological stress ECG at 3-month follow-up and received coronary angiography (2.5% for group 1 and 4.1% for group 2). The first such 1 patient showed a de-novo stenosis distally to the LIMA-LAD anastomosis and received an uneventful reoperation. In the second such group 1 patient, a vein graft of the marginal branch of the circumflex artery was occluded. This patient was treated with drug therapy. Both such patients in group 2 showed a stenosis of the LIMA and anastomosis between 50%70%, and insisted on drug therapy.
Pain assessment
On postoperative day 3 all patients underwent chest and back pain evaluation using the Visual Analog Scale (VAS) pain scale. In group 1, 68% of the patients had a pain intensity registering from 0 to 2 points versus 65% of group 2 having pain intensity between 3 an 6 points on the VAS pain scale (p < 0.05, Mann-Whitney U Test). Back pain evaluation found 90% of group 1 claiming no pain at all versus 50% of group 2 claiming back pain with intensity from 1 to 8 points on the VAS pain scale (p < 0.05, Mann-Whitney U Test).
Comment
The encouraging early results of the pioneers in the new field of cardiac surgery, using the so-called minimally invasive procedures [1, 2, 10], stimulated many cardiovascular departments to work with these novel techniques [3, 11, 12,]. The idea of performing coronary bypass operation using CPB and cardioplegic arrest and avoiding median sternotomy was first introduced in Europe by the Dresden group in an initial successful clinical trial [4] and re-enforced by the experiences of the Stanford Group. Performing Port-Access procedures, we faced a thorax herniation and therefore moved the chest incision from the bed of the fourth rib to the third intercostal space. We realized very soon that access to the ascending aorta can be obtained, and therefore the complexity of the endovascular CPB system of Heartport is not necessary. In time, and after having gained experience in reaching both heart and ascending aorta, we started attaching additional aortocoronary vein grafts, realizing that the treatment of multivessel CAD under less invasive conditions is feasible [5]. As the first patients received this new procedure, CPB was instituted femorally and if the complexity of the Port-Access system was eliminated, there were still some problems to overcome, such as groin wound infections and retrograde flow in the aorta. The real advantage of the DT compared to other similar techniques became very obvious as direct cannulation of the aorta and percutaneous transfemoral right atrium cannulation was enabled, thus diminishing the danger of intraoperative development of aortic dissections [4, 9] and postoperative wound-healing complications in the groin. The routine use of the DT proved that, despite its small chest incision, it provides good access to all areas of the heart and even enables the use of multiple coronary artery bypass grafting procedures. If we prove that the DT is (despite the learning curve) at least as good as the conventional technique, our findings would emphasize the importance of the DT to patients, such as those with a tracheostoma and those who use walking sticks, who would definitely benefit from a procedure that avoids median sternotomy.
A thorough preoperative evaluation of the patients allows a very low conversion rate (1.2%). Even though time of operation was longer in the DT group, ICU stay was 1 day for both groups. The lack of difference in hospitalization times between both groups in this study can be attributed partially to customary practices of the German medical care system, but still shows that the DT is not combined with higher morbidity. Clinical classification in CCS and NYHA and evaluation of ECG and CKMB/CK fraction did not weigh in favor of either technique. These findings were confirmed by stress ECG and angiogram with results equal to those submitted by other authors [13]. Bleeding rates and blood transfusion requirements are lower in the DT group compared to those of the conventional technique group, probably because of the DTs smaller wound surface. Based on these factors in combination with decreased back pain, we conclude that convalescence can be enhanced by the use of the DT. Because the DT allows complete revascularization in complex cases of coronary artery multivessel disease, this technique should probably be the method of choice in patients with serious risk factors for median sternotomy, and for these patients who request operation without MS for cosmetic reasons.
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