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Ann Thorac Surg 2009;87:1416-1420. doi:10.1016/j.athoracsur.2009.02.090
© 2009 The Society of Thoracic Surgeons
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Original Articles: Adult Cardiac

Intermediate-Term Patency of Saphenous Vein Graft With a Clampless Hand-Sewn Proximal Anastomosis Device After Off-pump Coronary Bypass Grafting

Tomoki Shimokawa, MD*, Susumu Manabe, MD, Takahiro Sawada, MD, Shigefumi Matsuyama, MD, Toshihiro Fukui, MD, Shuichiro Takanashi, MD

Department of Cardiovascular Surgery, Sakakibara Heart Institute, Tokyo, Japan

Accepted for publication February 27, 2009.

* Address correspondence to Dr Shimokawa, Department of Cardiovascular Surgery, Sakakibara Heart Institute, 3-16-1 Asahicho, Fuchu City, Tokyo, 183-0003, Japan (Email: tshimokawa-circ{at}umin.ac.jp).


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 References
 
Background: To avoid complications related to aortic manipulation, devices were developed to perform clampless anastomosis. However, there are few studies concerning the late patency of the graft. The aims of this study were to investigate the patency rate of saphenous vein (SV) graft after off-pump coronary artery bypass grafting (OPCAB) and to evaluate the influence of a clampless hand-sewn proximal anastomosis on late graft patency.

Methods: Patients (n = 232) were enrolled who underwent OPCAB with SV grafts from 2004 to 2007 and had follow-up angiography. For proximal anastomoses, a clampless device was used in 73 (group A; HEARTSTRING [Guidant Corporation, Santa Clara, CA] in 54, Enclose II [Novare Surgical Systems, Inc, Cupertino, CA] in 19), and partial clamping was used in 159 (group B). The proximal anastomosis procedure was modified according to the results of epiaortic ultrasonography. Coronary angiography was performed early (11.8 ± 10.4 days) and one-year postoperatively (n = 180, 371.5 ± 102.6 days).

Results: There were no significant differences in patient characteristics between the two groups except for a higher reoperation rate in group A. The overall SV patency rate at the early and one-year postoperative angiography was 95.7% and 83.0%, respectively. The patency rates were similar between the two groups (early: 97.3% vs 98.1%, p = 0.729; 1 year: 87.0% vs 81.3%, p = 0.316). There was also no significant difference in the target vessel revascularization rate during follow-up (6.8% vs 10.1%, p = 0.623).

Conclusions: Intermediate-term angiographic follow-up demonstrate an acceptable SV patency rate after OPCAB. The SV patency rate with a clampless device for proximal anastomosis is comparable with that with partial clamping during the first postoperative year.


   Introduction
Top
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 References
 
Off-pump coronary artery bypass (OPCAB) has been suggested to reduce postoperative neurologic events. However, manipulation of the ascending aorta during construction of proximal aortocoronary bypass anastomosis may produce particulate cerebral emboli with adverse neurologic outcome [1]. To avoid this problem, devices were developed to perform clampless anastomoses. Recently, new proximal seal devices, the HEARTSTRING (Guidant Corporation, Santa Clara, CA) and Enclose II (Novare Surgical Systems, Inc, Cupertino, CA), were introduced to facilitate the creation of a clampless hand-sewn coronary artery bypass-to-ascending aorta anastomosis. The use of these devices yielded encouraging results in terms of neurologic complications and early patency [2, 3]. Nevertheless, there is concern about the late patency rate because the first-generation automatic anastomotic device provided unacceptable patency within 6 months [4, 5]. The aims of this study were to investigate the patency rate of saphenous vein (SV) graft after OPCAB and to demonstrate the influence of a clampless hand-sewn proximal anastomosis on late graft patency.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 References
 
This study enrolled 232 consecutive patients with postoperative early angiography after isolated OPCAB surgery using SV grafts from September 2004 to March 2007. We compared the angiographic results with two techniques for creating anastomoses: a clampless device in 73 patients with 74 SV grafts (group A; HEARTSTRING device in 54, Enclose II device in 19), and partial clamping in 159 patients with 161 SV grafts (group B). During the same period, 288 patients underwent OPCAB with aortocoronary SV bypass. The patient exclusion criteria for postoperative angiography were age greater than 80 years in 38 patients, impaired renal function in 11, chronic obstructive pulmonary disease that required tracheostomy in 3, severe peripheral vascular disease in 2, and postoperative severe conditions in 2 (mediastinitis and gastrointestinal bleeding). For all study patients early angiography was performed before discharge (11.8 ± 10.4 days) to evaluate the patency of the graft and anastomosis, and a follow-up study was planned for 1 year after surgery regardless of symptoms. A board-certified cardiologist reviewed all angiography results and graded the degree of stenosis. All patients signed informed consent forms before the operation and each angiography. The study protocol was approved by the Institutional Review Board and the necessity for patient consent regarding this study was waived.

The preoperative characteristics of the patients are shown in Table 1. Risk factors included diabetes mellitus (diet controlled, oral agent-treated, or insulin-treated), hyperlipidemia (total cholesterol ≥ 240 mg/dL or oral agent-treated), and hypertension (systolic blood pressure ≥ 140 mm Hg, diastolic blood pressure ≥ 90 mm Hg, or oral agent-treated). Every patient was given an intravenous heparin injection 6 hours after surgery to prevent perioperative stroke and myocardial infarction. Most patients had low-dose aspirin (81 mg/day) from the first postoperative day. Coumadin was prescribed for at least 6 months and was maintained at a target international normalized ratio of 2.0 to 2.5. Target vessel revascularization was defined as repeat revascularization of the initial grafted vessel. The SV graft-related vessel revascularization was defined as repeat revascularization of the initial SV graft.


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  		Table 1 Patient Characteristics
 
Surgical Technique
The technique of OPCAB has been described previously [6]. The SV graft was our first choice for revascularization of the right coronary artery territory, and bilateral internal thoracic artery (ITA) and radial artery (RA) grafting for the left coronary territory was the standard method. We used SV graft for the left coronary territory when arterial conduits were in poor preoperative condition on angiography and ultrasonography, arterial conduits had already been used in previous operations, or an emergency operation was necessary.

Full anticoagulation was achieved with heparin (3.0 mg/kg). We bypassed all significantly diseased coronary vessels with a diameter greater than 1 mm. After completion of the distal anastomoses, the proximal RA or SV graft anastomoses were performed on a disease-free segment of the aorta as assessed by epiaortic ultrasonography (Sonos 7500; Philips Medical Systems, Andover, MA). The proximal anastomosis procedure was modified according to the results of epiaortic scanning [7]. An anterior segment of normal or mildly diseased aorta entirely was required for the partial clamping technique, and a segment partially free of disease for the clampless device. The selection of the two anastomotic devices depended on the preference of each surgeon. In patients with severe aortic atherosclerosis, the operative procedure was modified to an aortic-no-touch technique. All proximal anastomoses were constructed manually with continuous 6-0 polypropylene using a blower-mister device to enhance visualization.

Statistical Analysis
Statistical analyses were performed with SPSS software (SPSS Inc, Chicago, IL). All data were expressed as means ± standard deviation. Univariate analysis was determined by a Mann-Whitney test for continuous variables or the Fisher 2-tailed exact test for categoric variables. Multivariate analysis was performed using the logistic regression method. All p values less than 0.05 were taken as significant.


   Results
Top
 Abstract
 Introduction
 Material and Methods
 Results
Comment
 References
 
There were no significant differences in patient characteristics between the two groups except for a higher rate of reoperation in group A than in group B (6.8% vs 0.6%, respectively, p = 0.013). The number of distal anastomoses and SV graft distal anastomoses were similar in both groups (4.4 ± 1.2 vs 4.6 ± 1.2, p = 0.133; 1.4 ± 0.7 vs 1.4 ± 0.6, p = 0.440, respectively). No patients had postoperative neurologic complications in this study. The incidence of postoperative heparin administration, aspirin intake, and Coumadin (DuPont, Wilmington, DE) intake were also similar in both groups (95.9% vs 95.6%, p = 1.00; 100% vs 99.4%, p = 1.00, 97.3% vs 96.2%, p = 1.00, respectively). Postoperative early angiography demonstrated a 97.3% graft patency rate of the SV (FitzGibbon grade A+B) in group A and 98.1% in group B (p = 0.729), as shown in Table 2. The ITA graft showed an excellent patency rate in both groups A and B, even though most of the LITA (left internal thoracic artery) grafts were anastomosed to the left anterior descending coronary artery. There was no significant difference between the two groups in the patency rate of the LITA (100% vs 98.7%), RITA (right internal thoracic artery; 100% vs 100%), and RA (96.7% vs 98.9%).


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  		Table 2 Early Patency Rate
 
Among all enrolled patients, 53 patients declined one-year follow-up angiography because of noncardiac death in 2, cerebral infarction in 3, and no symptoms in 48 within one year after the operation. As a result, one-year angiography was performed in 180 patients with 182 SV grafts (group A, n = 53; group B, n = 127; 371.5 ± 102.6 days). The incidence of aspirin and Coumadin intake at one-year angiography were similar in both groups (100% vs 98.4%, p = 0.100; 39.6% vs 47.2%, p = 0.412, respectively). The overall SV graft patency rate decreased significantly during the first postoperative year (early 95.7% vs one-year 83.0%, p < 0.0001). Postoperative one-year angiography demonstrated an 87.0% patency rate of the SV graft (FitzGibbon grade A+B) in group A and an 81.3% rate in group B (p = 0.316), as shown in Table 3. There was also no significant difference between the two groups in the patency rate of the LITA (100% vs 97.6%), RITA (91.1% vs 91.6%), and RA (65.2% vs 83.1%). Univariate analysis demonstrated a higher incidence of hyperlipidemia (27 of 33, 81.8% vs 124 of 199, 62.3%, p = 0.029) and less Coumadin use (3/33, 9.1% vs 5/199, 2.5%, p = 0.089) in the occluded SV-graft group than in the patent SV-graft group. Multivariate logistic regression analysis showed hyperlipidemia (odds ratio [OR] 2.59, 95% confidence interval [CI] 1.02 to 6.6, p = 0.046) to be an independent predictor of SV-graft failure during the first postoperative year after OPCAB.


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  		Table 3 One-year Patency Rate
 
Twenty-one of 230 survivors underwent target vessel revascularization during the follow-up period at 21.7 ± 10.0 months. In group A, 2 of 7 target vessel revascularizations were related to vein graft occlusion, whereas 9 of 16 were related to occlusion in group B. There were no significant differences in the rate of target vessel revascularization and SV-related vessel revascularization rates between the two groups (6.8% vs 10.1%, p = 0.623; 2.7% vs 5.7%, p = 0.510, as shown in Table 4).


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  		Table 4 Target Vessel Revascularization
 

   Comment
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
References
 
The present study demonstrated the following main findings. First, the overall SV graft patency rate decreased significantly during the first postoperative year. Second, the early and one-year patency rates were similar between patients with device and partial clamping. The use of a proximal hand-sewn device was not an independent predictor of graft failure during the first year after OPCAB. Third, there were also no significant differences in rate of all target vessel and SV graft-related target vessel revascularizations. To our knowledge, this is the novel study in OPCAB comparing the effect of a clampless hand-sewn proximal anastomosis device and partial clamping on intermediate-term SV graft patency rate.

Although the SV is still the most widely used graft because of its accessibility and ease of use, the surgical results of coronary artery bypass grafting (CABG) have demonstrated that SV long-term patency is lower than that of the ITA [8, 9]. Long-term angiographic studies of CABG grafts show occlusion rates of 15% to 20% at one year, increasing to 40% at ten years [9, 10]. The SV patency after CABG is influenced by three processes: thrombosis, fibrointimal hyperplasia, and vein graft arteriosclerosis [11]. Thrombosis accounts for most graft failures within the first month, but continues to occur as long as one year after CABG. Fibrointimal hyperplasia occurs predominantly after one month to five years, and SV arteriosclerosis may begin as early as the first year but is fully developed only after about five years. Graft failure has consequences similar to those of native coronary artery disease: recurrent angina, myocardial infarction, additional revascularization procedures, and premature death [12]. Two meta-analyses using several randomized trials showed that OPCAB significantly increased the risk of graft failure within the first postoperative year [13, 14]. These results suggested that lower SV graft patency rates result from the type of graft, the exposure and quality of stabilization, and increased procoagulant activity in OPCAB patients. Procoagulant activity is a well-known phenomenon in major general surgery and is increased in the first 24 hours after OPCAB [15]. This phenomenon may increase the risk of venous thrombosis and potentially endanger the patency of coronary anastomoses. Therefore, perioperative anticoagulation for patients undergoing OPCAB should be more aggressive than that for patients undergoing conventional CABG. In this study, preoperative aspirin was discontinued before surgery. Postoperative intravenous heparin, oral aspirin, and Coumadin were given to all patients without side effects. Our results demonstrated that the overall SV patency rate at the early and one-year postoperative angiography was 94.2% and 84.8%, respectively. Those rates are similar to the SV patency rate after conventional CABG. Recently, Magee and colleagues [16] reported that the SV graft failure rate was 25% in both on-pump and off-pump CABG in a prospective randomized study [16]. Although we found hyperlipidemia as the only predictor of SV graft failure, they reported that target artery quality, length of surgery, sequential grafts, body weight, endoscopic harvest technique, and graft quality were all independent predictors.

Proximal anastomotic devices have been introduced to reduce aortic manipulation and therefore, associated complications. Devices have been classified as either automatic or manual. The automatic devices allow anastomoses between the conduit and aorta through automated connectors and deployment systems. Automatic anastomotic devices using connector technology are technically more complex, and problems regarding cost and early patency rates have been reported [17]. In a prospective randomized study comparing the Symmetry-supported anastomotic procedure with the conventional suture technique, a 38% stenosis rate was observed with the Symmetry device (St Jude Medical Inc, St. Paul, MN) versus 0% for hand-sewed anastomoses [18]. Because the observed rate of stenosis was not acceptable, many surgeons stopped further clinical use of the device. Lower patency rates have been attributed to the following causes: the 90 degree angulation of the venous graft with the ascending aorta may cause kinking and graft occlusion if an unsuitable site for proximal anastomosis is chosen; loading the vein onto the delivery system may produce intimal lesions and later intimal hyperplasia; and nitinol may play a role in the progression of neointimal hyperplasia [17, 18].

Although a new automatic device (CorLink device [Bypass Ltd, Herzelia, Israel] and PAS-Port device [Cardica, Inc, Redwood City, CA]) has recently been introduced [19, 20], we believe that hand-sewing using a running suture is the gold standard for creation of a vascular anastomosis because it is reliable and reproducible. The HEARTSTRING and Enclose II are simple manual anastomotic devices that allow the choice of performing distal or proximal anastomoses first, facilitating the proximal anastomosis. Early clinical results have been satisfactory in terms of ease of use, neurologic complications, and early graft patency [2, 3]. In our experience with 109 patients using the HEARTSTRING or Enclose II, no patients had difficulty achieving hemostasis. Furthermore, no hospital mortality or intraoperative stroke related to the device was observed [21]. The present study demonstrated a satisfactory intermediate-term SV patency rate with a proximal hand-sewn device. These results suggest these devices can be useful for CABG in case the ascending aorta shows atheromatous disease on epiaortic ultrasonography.

In this study most of the radial artery was used as a Y-composite graft and the patency rate of the radial artery was lower at one-year angiography. We guess the use of radial artery as a Y-composite graft to mild stenosed target coronary artery resulted in a poor prognosis. When performing a multiple arterial grafting, the selection of graft material and graft design is especially important to gain the advantages of arterial grafts.

There are a few limitations of this study that must be recognized. First, the present study was not performed in a randomized manner with regard to the conditions of the ascending aorta, the graft, and the target vessels, although the majority of veins were grafted to revascularize right coronary arterial territories. Patients with aortic atheromatous disease tended to avoid partial clamping, and this may have introduced bias into the patient selection process. Second, we might have overestimated the patency rates by selecting patients who survived and had angiograms performed both early and one year after surgery. We did not perform early postoperative angiography in patients greater than 80 years old, patients with impaired renal function, patients with severe peripheral vascular disease, or in patients in poor postoperative condition. It is possible that excluding these patients could have affected the difference between the two groups. Third, we used two different devices in the device group. It was difficult to assess which device was more useful in this study. Finally, this study was an observational study in a single institution. The size of the cohort was relatively small and the follow-up period was short. Further randomized, controlled studies with a larger sample size and a longer follow-up period will be mandatory to confirm the reliability of these devices and the factors associated with graft failure.

In conclusion, intermediate-term angiographic follow-up demonstrate an acceptable SV graft patency rate after OPCAB. The patency rate of SV graft with the clampless device for proximal anastomosis is comparable with that with partial clamping during the first postoperative year.


   References
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 

  1. Calafiore AM, Mauro, MD, Teodori G, et al. Impact of aortic manipulation on incidence of cerebrovascular accidents after surgical myocardial revascularization Ann Thorac Surg 2002;73:1387-1393.[Abstract/Free Full Text]
  2. Medalion B, Meirson D, Hauptman E, Sasson L, Schachner A. Initial experience with the Heartstring proximal anastomotic system J Thorac Cardiovasc Surg 2004;128:273-277.[Abstract/Free Full Text]
  3. Akpinar B, Guden M, Sagbas E, Sanisoglu I, Ergenoglu MU, Turkoglu C. Clinical experience with the Novare Enclose II manual proximal anastomotic device during off-pump coronary artery surgery Eur J Cardiothorac Surg 2005;27:1070-1073.[Abstract/Free Full Text]
  4. Reuthebuch OT, Kadner A, Lachat ML, Turina MI. Graft occlusion after deployment of the Symmetry bypass system Ann Thorac Surg 2003;75:1626-1629.[Abstract/Free Full Text]
  5. Vicol C, Oberhoffer M, Nollert G, et al. First clinical experience with the HEARTSTRING, a device for proximal anastomoses in coronary surgery Ann Thorac Surg 2005;79:1732-1737.[Abstract/Free Full Text]
  6. Fukui T, Takanashi S, Hosoda Y, Suehiro S. Early and midterm results of off-pump coronary artery bypass grafting Ann Thorac Surg 2007;83:115-119.[Abstract/Free Full Text]
  7. Shimokawa T, Minato N, Yamada N, Takeda Y, Hisamatsu Y, Manabu I. Assessment of ascending aorta using epiaortic ultrasonography during off-pump coronary artery bypass grafting Ann Thorac Surg 2002;74:2097-2100.[Abstract/Free Full Text]
  8. FitzGibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GD, Burton JR. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years J Am Coll Cardiol 1996;28:616-626.[Abstract]
  9. Goldman S, Zadina K, Moritz T, et al. Long-term patency of saphenous vein and left internal mammary artery grafts after coronary artery bypass surgery: results from a Department of Veterans Affairs Cooperative Study J Am Coll Cardiol 2004;44:2149-2156.[Abstract/Free Full Text]
  10. Desai ND, Cohen EA, Naylor CD, Fremes SE, Radial Artery Patency Study Investigators A randomized comparison of radial-artery and saphenous-vein coronary bypass grafts N Engl J Med 2004;351:2302-2309.[Medline]
  11. Nwasokwa ON. Coronary artery bypass graft disease Ann Intern Med 1995;123:528-545.[Abstract/Free Full Text]
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  13. Lim E, Drain A, Davies W, Edmonds L, Rosengard BR. A systematic review of randomized trials comparing revascularization rate and graft patency of off-pump and conventional coronary surgery J Thorac Cardiovasc Surg 2006;132:1409-1413.[Abstract/Free Full Text]
  14. Parolari A, Alamanni F, Polvani G, et al. Meta-analysis of randomized trials comparing off-pump with on-pump coronary artery bypass graft patency Ann Thorac Surg 2005;80:2121-2125.[Abstract/Free Full Text]
  15. Mariani MA, Gu YJ, Boonstra PW, Grandjean JG, van Oeveren W, Ebels T. Procoagulant activity after off-pump coronary operation: is the current anticoagulation adequate? Ann Thorac Surg 1999;67:1370-1375.[Abstract/Free Full Text]
  16. Magee MJ, Alexander JH, Hafley G, et al. Coronary artery bypass graft failure after on-pump and off-pump coronary artery bypass: findings from PREVENT IV Ann Thorac Surg 2008;85:494-500.[Abstract/Free Full Text]
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  18. Carrel TP, Eckstein FS, Englberger L, Windecker S, Meier B. Pitfalls and key lessons with the symmetry proximal anastomotic device in coronary artery bypass surgery Ann Thorac Surg 2003;75:1434-1436.[Abstract/Free Full Text]
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