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J Thorac Cardiovasc Surg 1998;116:60-67
© 1998 Mosby, Inc.
Surgery For Adult Cardiovascular Disease |
The study was supported by a grant from The Netherlands Heart Foundation (No. 1993/43.028) and the University Hospital, Utrecht (No. 1995/B903).
Received for publication Nov. 24, 1997. Revisions requested Jan. 15, 1998; revisions received Feb. 13, 1998. Accepted for publication Feb. 13, 1998. Address for reprints: Erik W. L. Jansen, MD, Heart-Lung Institute, Utrecht University Hospital (Room E03.406), P.O. Box 85500, 3508, GA Utrecht, The Netherlands.
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Introduction |
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1-6 and, more specifically, on reoperative surgery 7 mainly because the opinion has been that cardiac motion jeopardized anastomosis suturing. In addition, the internal thoracic artery (ITA) as a conduit 8,9 became widely accepted, but this delicate arterial graft requires meticulous anastomosis suturing. Nonetheless, Kolesov 10 in 1964 successfully performed left ITA grafting to the left anterior descending artery (LAD) on the beating heart.
Recently, the advent of video-assisted thoracic surgery 11 has introduced new less-invasive concepts on myocardial revascularization. This included Port-Access CABG on the arrested heart with CPB 12 and on the beating heart without CPB through limited incisions. 13 In our opinion, avoiding CPB is the most obvious and important aspect in less invasive CABG. Therefore adequate anastomosis site stabilization is indispensable. Recently, specific local cardiac wall stabilizers have become available. 14,15
The objective of this prospective study was to assess the safety and efficacy of the Octopus stabilizer in off-pump CABG. The Octopus tissue stabilizer (Medtronic, Inc., Minneapolis, Minn.) immobilizes and exposes the coronary artery by suction without adverse effects. 14 The early clinical results (2- to 22-month follow-up) and angiographic outcome (6-month follow-up) are reported in the first 100 patients in whom arterial grafts, predominantly, were used through full and limited surgical access.
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Methods |
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16 patients were classified in the following manner: good (74%), fair (12%), poor (11%), high (3%), and extremely high (0%). Two patients with a left ventricular ejection fraction less than 20% were operated on with intraaortic balloon pumping. At operation, the following data were sampled on-line event-related and stored in a computer: mean arterial blood pressure, heart rate, cardiac index, mixed venous oxygen saturation, and ST-segment elevation in lead V5. All patients were prepared as for conventional CABG to enable conversion of strategy any time in bail-out situations. Normothermia was maintained by a warm-water blanket.
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Cardiac wall stabilization
The Octopus tissue stabilizer (Fig. 1) consists of two (left and right) paddles with four or five suction domes each (internal diameter 6 mm) with a malleable segment, which allows precise adjustment to the cardiac surface. Each paddle is connected by an articulating arm to the operating table rail or to opposite rails (Fig. 2). The suction paddles are placed close to and parallel to the coronary artery to obtain maximum immobilization and minimum compromise of muscle function. Suction is activated in each paddle separately and fixes the target site once suction is –400 mm Hg. Additional immobilization in the z-direction was achieved by slight stretching of the intervening epicardium by subtle spreading of the paddles, resulting in residual target motion of about 1 x 1 x 1 mm. 14 Finally, to expose the target in addition to immobilization both paddles were moved simultaneously and then fixed in this position by freezing the articulating arms. The surgical technique has not yet been reported (unpublished data).
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17 To maximize access to the target site, one paddle was introduced through the incisional wound and one through a separate stab wound (used later for the drain) between the ribs. Simultaneous displacement of both paddles was essential to expose the diagonal branch for sequential diagonal LAD grafting.
Limited access: Subxiphoid approach for one-vessel grafting of the distal right coronary artery (RCA; four patients) and its proximal posterior descendens branch (one patient). Through a 10 cm upper midline laparotomy incision, the xiphoid cartilage was excised. After the right gastroepiploic artery had been harvested, grafting was performed with the use of the Octopus to stabilize the target vessel via the wound.
Full access: Median sternotomy, used for two-vessel (25 patients) and three-vessel (8 patients) grafting. The left ITA was dissected in the pedicled fashion; the right ITA was dissected in the skeletonized fashion to obtain more length. The anterior and inferior cardiac wall could then easily be exposed. Posterior wall exposure (tilting of the heart), however, required fluid supplementation and redistribution of blood volume (Trendelenburg maneuver) 18,19 and sometimes inotropic drug support to maintain adequate cardiac index and arterial blood pressure. The sternotomy approach was also used for one-vessel disease in three obese patients for a single right ITA bypass to the distal RCA and for three sequential diagonal LAD grafts with a wide-angled bifurcation.
Full access: Posterior thoracotomy, used for one-vessel (three patients) and two-vessel (one patient) grafting. The fifth intercostal approach was used for reoperation in three patients in whom sternotomy was considered contraindicated. Because the heart stays in its pericardial cradle, hemodynamics were not compromised.
Distal anastomosis
After treatment with heparin (1.5 mg/kg intravenously), the target area was immobilized and exposed. The coronary artery was occluded 5 minutes to evaluate signs of ischemic dysfunction, followed by 5 minutes of reperfusion for preconditioning, before occlusion for constructing the anastomosis. Temporary coronary shunts were not used. The coronary artery was dissected free over 15 mm to allow a 4 mm arteriotomy between two atraumatic microvascular clamps (Acland clamps; S & T Marketing, Neuhausen, Switzerland). The anastomosis was performed with a running polypropylene 8-0 suture with magnifying loupes (x2.5).
Revascularization assessment criteria
Electrocardiograms were recorded at least twice during admission, and serial myocardial fractions of creatine kinase (CK-MB) were determined six times up to 48 hours after surgery. Perioperative myocardial infarction was diagnosed in the presence of one or both of the following criteria: (1) myocardial fractions of creatine kinase levels above 50 IU and (2) the development of new Q waves. Bypass graft angiography was performed on the day before discharge in the first 10 patients. The graft quality was assessed by two independent observers, using the thrombolysis in myocardial infarction (TIMI) classification. 20 In the case of a disagreement, a discussion led to mutual concensus. At 6 months, all patients were scheduled for angiography.
Follow-up
The mean follow-up time was 13 months (range, 2 to 22 months). Follow-up information was collected through direct patient contact and from the referring cardiologist. Clinical outcome according to the CCS was assessed, including electrocardiography and exercise testing at 3 and 6 months.
Statistical analysis
All data are presented as mean ± standard deviation or as median and range. An unpaired Student t test was used to compare intraoperative mean values for limited and full access.
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14 requiring suturing was necessary once in 1720 lesions (0.06% of 172 anastomoses with 2 x 5 x 172 lesions). Within 10 minutes, the lesions began to resolve. Temporary segmental occlusion of the coronary artery only occasionally caused 1 to 2 mm ST segment elevation, which lasted a few minutes. The effect of local cardiac wall immobilization by suction is reflected in Table IV. Intraoperative continuous inotropic drug support (dopamine, >2 µg/kg) was necessary in 34 patients (34%), whereas only 10 patients (10%) still required this therapy on leaving the operating room. Conversion to CPB was necessary in two patients (2%). One patient with two-vessel disease and chronic atrial fibrillation did not tolerate temporary occlusion of the RCA. The procedure was converted to CPB without aortic crossclamping. In three patients, a sternotomy was performed in addition to anterior thoracotomy because of underrated LAD pathologic findings in combination with conduit length. In one of these patients, grafting was done on CPB.
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Postoperative course
In most patients, recovery was fast and uneventful. Ninety-seven patients were extubated within the first hours after surgery, and their intensive care unit stay was 24 hours.
Complications
The median peak myocardial fractions of creatine kinase was 10 units/L (range, 2 to 257 units/L). Myocardial infarction occurred in four patients (4%), requiring intraaortic balloon pumping for low cardiac output in two patients. Myocardial infarction related to the grafted vessel occurred in one patient in whom conversion to sternotomy was necessary. One patient required percutaneous transluminal coronary angioplasty of an ungrafted artery (identification error) and a 5-day continuation of preoperatively initiated intraaortic balloon pumping as the result of intraoperative myocardial infarction. One patient had prolonged respiratory insufficiency as the result of kyphoscoliosis with extremely restricted lung function. Reversible ischemic neurologic deficits occurred in two patients with preexisting cerebrovascular insufficiency, in whom a free ITA anastomosis had been performed on the ascending aorta. One of these two patients had also been converted to CPB. None of the patients experienced mental disorders. In 5 of the first 10 patients in the anterior thoracotomy group, an early pericarditis was observed electrocardiographically, probably related to a dry gauze pad that was used to improve exposure. The median postoperative length of hospital stay was 4 days in the limited access group and 5 days in the full access group. Within 1 month after surgery, 96% of patients had resumed their premorbid activities. The postoperative data are summarized in Table V.
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Follow-up
There was a 100% complete follow-up. At 13 ± 11 months (range, 2 to 22 months), one patient is using antianginal medication and 98 patients were in CCS class I. There was one late successful balloon angioplasty of an anastomosis site. An internal defibrillator was implanted in a patient with sustained ventricular tachycardia without residual ischemia, in the presence of preexistent poor left ventricular function.
Graft flow
Doppler flow signal detection was inconsistent.
Exercise testing
Six-month exercise testing was performed in 92% of patients, including the three patients who refused recatheterization. Signs of ischemia were present in two patients.
Six-month angiography
Six-month follow-up angiography was performed in 86 of 100 patients(86%), representing 147 of 172 anastomoses. Of these, nine anastomoses could not be visualized because of selective injection of the grafts (four right gastroepiploic arteries, two free ITAs, and two right ITAs) failed. The overall patency rate was 95%. One hundred eighteen anastomoses had a TIMI grade-3 full flow; 10 had a grade-2 flow; 4 had a grade-1 flow, and 6 were occluded. All single left ITA grafts to the LAD were patent.
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Discussion |
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13 based on retractor-mounted pressure fixation. The principal findings of this study are as follows: (1) The Octopus method immobilized all major coronary arteries well at the anastomosis site without adverse effects, reflected in a 95% patency rate; (2) the median hospitalization was relatively short (4 to 5 days), and social activities were resumed within 1 month; and (3) at the 2- to 22-month follow-up, 98 patients were in the CCS class I. Suction fixation can be used to immobilize and expose the target area, whether with the use of anterior thoracotomy (including 16% sequential grafts diagonal branch/LAD), subxiphoid approach or thoracotomy, and sternotomy for two- and three-vessel grafting, and future, truly minimally invasive, Port-Access. 14 Via sternotomy access, exposure of the anterior wall and inferior wall is well tolerated hemodynamically (Table IV
); therefore it may also be considered in patients with poor left ventricular function. Exposure of the posterior wall was tolerated, provided dislocation was performed slowly (approximately 1 minute). Fluid redistribution (Trendelenburg maneuver) 19 or administration and some inotropic drug support (dopamine in 67% of patients) helped to maintain arterial pressure. Thus, left ventricular dysfunction seems to be a relative exclusion criterion. The Octopus tissue stabilizer has no permanent adverse effects on the underlying myocardium or on a coronary branch when it happens to pass just beneath one of the suction cusps. 14 However, we prefer to avoid this. It is independent of surface irregularities, fatty tissue, and application site (ventriculoventricular [e.g., LAD] or atrioventricular [e.g., RCA]). While still applying the traditional CABG procedure in most of the patients, the new stabilizers allow surgeons to tailor CABG treatment individually to the patient. In our institution, the percentage of off-pump CABG with the use of the Octopus tissue stabilizer has increased to 12% in 1997. This percentage reflects patient selection according to our inclusion and exclusion criteria and, moreover, an active catheter-based program in our institution.
Advantages of off-pump bypass surgery
Off-pump bypass surgery conserves the blood constituents, avoids global myocardial ischemia, preserves the interventricular septal function, 21 and may avoid neuropsychologic deficits caused by malperfusion, microemboli from CPB, and atheromatous emboli from manipulation of the aorta. 22 In our experience no stroke with a permanent deficit occurred. The rapid psychosomatic recovery of the patients was striking. Postoperative length of hospital stay was reduced by 2 to 3 days in our institution. Cognitive functions appeared to be well preserved in these patients but were not formally tested. Moreover, off-pump CABG reduced the need for blood products; in this series only 18% of patients needed blood products, on average two units, which may be further reduced with the use of a cell salvage device. The incidence of paroxysmal atrial fibrillation was low (12%), compared with on-pump CABG, 23 but contrary to our expectation the problem was not totally abolished. Undoubtedly, there is morbidity, reflecting the learning curve (for example, the acute sterile pericarditis leading to early readmissions). The results justify off-pump CABG to be considered in patients with associated disease, especially cerebrovascular insufficiency and renal insufficiency 6 and also in the very elderly patients in whom in-hospital mortality rates may be as high as 11.5%. 24
Limitations
Patients with diffuse coronary artery disease requiring long anastomoses and multiple (>4) grafts and with intramyocardial LAD are unsuitable candidates. The globally arrested heart allows more time-efficient bypass grafting compared with the installation of a stabilizer for each vessel separately.
The decisive factor in the acceptance of off-pump CABG will be the early angiographic patency rate. At 6 months, the patency rate of the single left ITA-LAD graft was 100%. Overall, 95% of anastomoses were angiographically patent at 6 months. Most failures were found in side-to-side anastomoses (of the diagonal branch) and reflected a learning curve. The standard of comparison will be on-pump CABG with the left ITA to the LAD as single-vessel CABG 25 and multivessel CABG 26,27 with a long-term 96% patency rate of the left ITA. 9 With arterial grafts, in this series 96%, favorable long-term patency may be expected. Alternatively, catheter-based interventional techniques are evolving, but their long-term results in multivessel disease are unknown. By reducing the restenosis rate, stenting may become increasingly competitive. 28,29 Although there is a learning curve for this type of CABG on the beating heart, the initial results are encouraging and seem cost effective. Randomized studies have been initiated in our institution to compare off-pump CABG with the Octopus tissue stabilizer to conventional CABG with CPB and to stenting.
Conclusion
By effective local cardiac wall immobilization, the Octopus tissue stabilizer facilitated limited and full-access CABG without CPB for selected patients with single- and multiple-vessel disease. Randomized trials seem warranted.
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Acknowledgments |
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