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Ann Thorac Surg 2008;85:1579-1584. doi:10.1016/j.athoracsur.2008.01.074
© 2008 The Society of Thoracic Surgeons
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Original Articles: Adult Cardiac

Twelve-Month Patency With the PAS-Port Proximal Connector Device: A Single Center Prospective Randomized Trial

Jörg Kempfert, MD*, Ulrich T. Opfermann, MD, Markus Richter, MD, PhD, Torsten Bossert, MD, Friedrich W. Mohr, MD, PhD, Jan F. Gummert, MD, PhD

Department of Cardiac Surgery, Heartcenter, University of Leipzig, Leipzig, Germany

Accepted for publication January 18, 2009.

* Address correspondence to Dr Kempfert, University of Leipzig, Heartcenter, Department of Cardiac Surgery, Strümpellstr. 39, Leipzig, D-04289, Germany (Email: kempfert{at}web.de).


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 
Background: The PAS-Port (Cardica Inc, Redwood City, CA) is an automated system that allows for the clampless anastomosis of vein grafts to the aorta. The intent of this study was to prospectively compare one year graft patency of this system with conventional hand-sewn anastomoses in a prospective, randomized trial.

Methods: A total of 99 patients undergoing elective off-pump coronary bypass surgery were randomized to receive their proximal anastomoses with either the hand-sewn conventional technique or with the PAS-Port system. Patient follow-up consisted of multislice computed tomographic scans performed at discharge and one year postoperatively.

Results: Three patients had to be converted to on-pump due to technical reasons. Fifty-one patients were randomly assigned to the PAS-Port group and 48 patients to the control group. In five patients in the control group severe atherosclerosis of the aorta required cross-over to the use of the PAS-Port device, and in one patient in the PAS-Port group conversion to a hand-sewn anastomosis. Sequential anastomoses were performed in 88% of the control group and 73% of PAS-Port group grafts. Time needed for completion of the proximal anastomosis including graft loading was 187 ± 19 seconds for the PAS-Port group and 406 ± 34 seconds for the control group (p < 0.001). One patient died unrelated to cardiac events due to septic multiorgan failure and one stroke was observed in the control group. There was a trend toward a lower rate of postoperative delirium in the PAS-Port group (11.7% vs 25%, p = 0.088). Patency at discharge (100% PAS-Port group vs 97.8% control group) and after one year (97.8% PAS-Port group vs 93.7% control group) were comparable. One patient of the PAS-Port group died during long-term follow-up as a result of a severe stroke due to cerebrovascular disease.

Conclusions: This prospective randomized study demonstrated excellent short and midterm patency in both the hand-sewn and PAS-Port grafts. The PAS-Port system allowed for the rapid, safe, and effective creation of a proximal anastomosis without the need to clamp the aorta. Based on this study we consider this product a valid alternative for proximal anastomosis, especially in patients with severe aortic disease, to avoid side clamping of the aorta.


   Introduction
Top
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 Acknowledgments
 References
 
With the wide acceptance of off-pump bypass procedures, cross-clamping of the aorta is no longer required to initiate cardiac arrest allowing the creation of distal anastomosis. Therefore, proximal anastomotic devices regained some interest to further minimize manipulation of the aorta. After the first device had been evaluated as early as 1979 [1], a variety of different devices have gained regulatory approval [2]. The most frequently used one was the St. Jude Symmetry (St Jude Medical Inc, St. Paul, MN) with, according to the manufacturer, more than 80,000 implants worldwide. However, after initial enthusiasm, reports of early graft stenoses [3] finally led to the withdrawal of the device in 2004 [4].

Despite the shortcomings of the Symmetry device the potential advantages of proximal anastomotic devices, such as avoiding placement of clamps on the aorta, time savings, facilitation of limited access surgery, and standardization of the anastomosis, remain an interesting surgical proposition. The Cardica PAS-Port system (Cardica Inc, Redwood City, CA) was introduced into the European and Japanese market in 2003 and 2004, respectively. The main differentiating features of the PAS-Port system are that in contrast to the Symmetry device the endothelium of the vein is left untouched during the loading and deployment process. Furthermore, the design of the PAS-Port device minimizes the amount of artificial material exposed to blood, which is seen as one of the key mechanisms affecting long-term graft patency. Finally, in PAS-Port anastomosis there is no metal in the orifice of the graft (Fig 1).


Figure 1
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  		Fig 1. Enrollment and crossover. (Pts = patients.)

 
The results of two nonrandomized multicenter trials [5, 6] were very encouraging [6]. Except for one study [7] in which the PAS-Port device was used in only nine patients, this product has not been studied in a prospective randomized trial assessing safety and midterm graft patency.

This prospective randomized single center study compares clinical outcome, safety, and midterm graft patency in patients undergoing off-pump coronary artery bypass grafting (OPCAB) with the PAS-Port device or hand-sewn proximal anastomosis.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 Acknowledgments
 References
 
Study Design
After approval by the local ethics committee of the University of Leipzig, and written consent obtained from each patient, 99 patients scheduled for elective coronary artery bypass grafting (CABG) were enrolled in this single center study at the Heartcenter, Leipzig. From July 2003 to April 2005, patients were randomly assigned to receive either the proximal vein graft anastomosis with the PAS-Port device (PAS-Port group) or by the conventional hand-sewn technique (hand-sewn group).

For a Pas-Port anastomosis no clamping of the aorta was necessary; for the hand-sewn anastomosis standard side clamping of the aorta was performed. Epiaortic ultrasound was not available.

Primary endpoints were patency at discharge and patency after one year evaluated by multislice computed tomographic (CT) scans. The secondary endpoints were frequency of neurologic events and other anastomosis-related adverse events. In accordance with the American Psychiatric Association guidelines, postoperative delirium was defined as a transient mental syndrome of acute onset characterized by global impairment of cognitive functions, reduced level of consciousness, attentional abnormalities, increased or decreased psychomotor activity, and disordered sleep-wake cycle [8, 9]. The diagnosis of delirium was made by physicians involved in the daily clinical care of patients and was most frequently made while patients were in the intensive care unit. Patients with prolonged delirium or focal neurologic signs underwent computed tomography of the brain to look for evidence of stroke [10]. Stroke patients with delirium were included in the study cohort.

Exclusion criteria were age under 70 years or preoperative established need for complete arterial revascularization, concomitant valve disease, renal failure, history of cerebral vascular accidents, nonelective coronary bypass surgery, history of an acute myocardial infarct with elevated troponin levels within two weeks prior to surgery, and a left ventricular ejection fraction (EF) of less than 0.3.

Study Population
Patient demographics are shown in Table 1 and were comparable. A total number of 99 patients were included; 51 patients were randomized to the PAS-Port group and 48 to the hand-sewn-group. Enrollment had to be discontinued in April 2005 because the PAS-Port device was temporarily not available in Germany (Guidant Inc. discontinued the distribution). Since the end of 2006 the device can be directly ordered from the manufacturer.


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  		Table 1 Patient Demographics
 
Technical Aspects
The PAS-Port system is a single use device for proximal vein graft anastomosis with a one size coupler suitable for grafts ranging from 4 to 6 mm in outside diameter. Loading of the device is accomplished by pulling the graft through the implant and manually everting the proximal end of the graft over the end of the implant. With the help of a poke-through tool, the everted vein is firmly attached to the implant. The loaded device is then placed on the aorta and the proximal anastomosis is performed by rotating a knob on the deployment tool. The device creates the aortotomy and places the implant in one single motion. The design of the system requires performing the proximal anastomosis first. The position of the proximal anastomosis was chosen to avoid any kinking of the graft and it was tried to achieve a 90 degree take off angle according to the recommendation of the device manufacturer.

In this study all procedures were planned as OPCAB and were performed according to the routine for coronary surgery in our center by one experienced senior surgeon. The surgeon was trained in a wet lab with more than ten anastomoses and has clinically performed more than 20 anastomoses, using the device before beginning the study. There were no occlusions in the early phase. All patients received clopidogrel (75 mg per day) and acetylsalicylic acid (100 mg per day) for six months, generally starting within 24 hours after extubation.

Angio-CT
To asses graft patency, a four-row multislice spiral CT angiography with retrospective gating was used. The CT scans were read by a radiologist and cardiologist and the graft was either described as open or occluded. In case of an occluded graft the patient received an angiogram to confirm the result.

Statistical Analysis
Statistical analysis was performed using SPSS statistical software (SPSS v. 10.0.7; SPSS, Inc., Chicago, IL). Continuous data are presented as mean ± standard error of the mean and categoric data as percentages. For comparison of categoric data the Pearson {chi}2 test and, for continuous data, the independent t test were utilized.


   Results
Top
 Abstract
 Introduction
 Material and Methods
 Results
Comment
 Acknowledgments
 References
 
Perioperative Data
Three patients had to be converted electively to on-pump due to technical reasons. In all but one case, the left internal mammary artery was anastomosed to the left descending coronary artery. All vein grafts were suitable for the PAS-Port device with a mean diameter of 4.75 mm. Each patient received one proximal vein anastomosis and distal anastomoses were done in a sequential fashion as required. As a result, sequential grafting was performed in 73% of the PAS-Port group patients and 88% of the hand-sewn group patients (p = 0.064).

In five patients of the hand-sewn group, the PAS-Port device was used instead of the initially planned hand-sewn anastomosis due to preoperatively not recognized severe aortic calcification. One patient in the PAS-Port group had to be converted to a hand-sewn anastomosis because of a proximal tear of the vein graft during deployment. In one PAS-Port patient the aortotomy was unsuccessful due to a technical problem. The PAS-Port anastomosis could successfully be completed by using a second device. Additional stitches for complete hemostasis were placed in 13 of the total 55 PAS-Port anastomoses (23%).

Time to prepare and complete the proximal anastomosis was significantly shorter in the PAS-Port group. Time needed for completion of the proximal anastomosis, including graft loading, was 187 ± 19 seconds for the PAS-Port group and 406 ± 34 seconds for the control group (p < 0.001). There were no statistically significant differences regarding standard intraoperative variables between the groups (Table 2).


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  		Table 2 Intraoperative Variables
 
Postoperative Course
Postoperative troponin T levels at 48 hours were comparable (0.4 ± 1.5 PAS-Port vs 0.6 ± 1.6 hand-sewn, p = 0.563). One patient in the hand-sewn-group suffered a stroke confirmed by CT scan on postoperative day one.

Six (11.7%) patients in the PAS-Port group and 12 (25%) in the hand-sewn group presented with postoperative delirium, resulting in a prolonged stay on intermediate or intensive care units. This trend toward a decreased rate of delirium in the PAS-Port group failed to reach statistical significance (p = 0.088). In one hand-sewn case reoperation for bleeding was necessary (no surgical bleeding) and one patient of the hand-sewn group developed, postoperatively, a low cardiac output syndrome (extracorporeal membrane oxygenation treatment for 14 hours) and was successfully weaned and eventually discharged. There was one in-hospital death in the hand-sewn-group due to postoperative septic multiorgan failure.

Discharge Graft Patency
Before discharge, patency was evaluated by multislice CT scan. In the PAS-Port group patency evaluation was performed by CT scan in 45 and by angiogram in six cases, resulting in a 100% follow up. All anastomoses in the PAS-Port group were found to be patent.

In the hand-sewn group, patency evaluation was performed by CT scan in 43 and by angiogram in two cases. One patient refused to undergo CT scan, one patient died due to septic multiorgan failure, and one patient presented with renal insufficiency thus not allowing angio-CT or angiography, resulting in missing data in three patients. One graft was occluded at the distal anastomosis site, but no reintervention was necessary.

As shown in Table 3, patency at discharge was 97.8% (44 of 45) and comparable (p = not significant) to the PAS-Port group (100%). In the "as-treated" analysis, all 55 patients (100%) with PAS-Port implants and 43 of the 44 patients (97.7%) with hand-sewn proximal anastomosis were found to be patent at discharge.


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  		Table 3 Discharge Patency
 
Twelve-Month Graft Patency
At 12 months postoperatively one patient of the PAS-Port group has died unrelated to cardiac events (severe stroke on postoperative day 81). Forty-five of the 50 patients alive in this group at 12 months returned for CT evaluation (90% compliance). Reasons for missing data were renal insufficiency (n = 3) and refusal (n = 2) as shown in Table 4. Twelve months postopertatively, in the PAS-Port-group, one graft was occluded with the need for angioplasty, resulting in a patency rate of 97.8% (44 of 45).


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  		Table 4 Twelve-Months Follow-Up
 
In the hand-sewn group patient compliance at 12 months was significantly lower. Only 32 of the 47 patients discharged returned for CT evaluation (68.1% compliance). In addition to the one graft that was occluded at discharge, a second vein-graft in another patient was occluded at 12 months but did not require any intervention. Graft patency in the hand-sewn group was therefore 93.7% (30 of 32).

In the "as–treated" analysis, 12 month patency for the PAS-Port-patients was 97.9% (46 of 47) with a compliance of 85.5% (47 of 55) and in the hand-sewn patients 93.3% (28 of 30) with a compliance of 68.2% (30 of 44). Patency for groups defined by "intention to treat" or by "as-treated" were not statistically significantly different (Table 5).


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  		Table 5 Twelve-Month Patency
 

   Comment
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
Acknowledgments
 References
 
The average age of patients scheduled for coronary artery bypass procedures has continually been rising over the past decade and this has been associated with a significant change in the patient risk profile [11]. In this higher risk subpopulation, off-pump surgery with avoidance of cross-clamping of the aorta, extracorporeal circulation, and cardioplegic arrest has demonstrated advantages in terms of a reduction in the incidence of stroke, prolonged respiratory failure, bleeding, transfusions, and intensive care unit and hospital length of stay [12, 13]. To further reduce the risk of cerebral vascular accidents, some surgeons have advocated the use of the "no touch" technique, in which bilateral mammaries are used with or without a radial artery as a T-graft to revascularize the heart [14]. But as this approach is considered technically highly demanding, and the use of all arterial grafting in patients with advanced age may not provide the merits seen in a younger population, creation of the proximal anastomosis for vein-grafts with the need for partial clamping is still indispensable. The potential for neurologic complications associated with clamping of the aorta had triggered the advent of novel technology that would allow the connection of bypass grafts to the aorta without the need for clamping. The St. Jude Symmetry device was one of the first proximal anastomotic devices to gain approval and after initial enthusiasm reports of early graft stenosis and increased incidence of major adverse cardiac events (MACEs) appeared in the medical literature. Traverse and colleagues [3] reported an alarming rate of early stenosis at the connector side shortly after the procedure, requiring multiple reinterventions. Consistent with this report, Bergsland and colleagues [15] documented a patency rate of only 50% with the Symmetry device after five months by angiography and patients treated with the device showed a significant increased incidence of early MACEs after one year [16]. Ultimately, the company voluntarily withdrew the device from the market in 2004. Unfortunately, the results of this early experience generated a general distrust in novel anastomotic technology in the cardiac surgical community. The goal of this prospective, randomized trial study was therefore to provide evidence for efficacy of a newer generation proximal anastomotic device, the Cardica PAS-Port system (Fig 2).


Figure 2
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  		Fig 2. Intraluminal view of a deployed Symmetry (left) and a PAS-Port device (right).

 
The results of this study showed that grafts attached with a PAS-Port device to the aorta had similar short and longer term safety and efficacy as grafts attached using the conventional hand-sewn technique. In grafts evaluated by multislice computed tomography the patency at discharge in the PAS-Port group was 100% (Fig 3) and 97.8% in the hand-sewn group. At the time of discharge none of the patients in the PAS-Port group had experienced a major adverse event such as stroke, death, or need for target vessel revascularization. Twelve months postoperatively, 45 of the 50 patients in the PAS-Port group alive returned for CT evaluation and 44 of the 45 grafts evaluated were found to be patent (Fig 4). In the hand-sewn group 30 of 32 grafts evaluated at 12 months were found to be patent. Overall these patency results compare favorably to those published in medical literature [17]. This may be explained by the fact that all patients in this study were kept on clopidogrel for six months [18]. In addition, a significant proportion of grafts (73% of the PAS-Port and 88% in the hand-sewn patients) in the study were used as sequential grafts, a variable that is known to increase overall blood flow through the proximal anastomosis [19]. Finally, all anastomoses were performed by an experienced senior surgeon. All of these factors may have contributed to the patency observed in this particular study.


Figure 3
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  		Fig 3. Computed tomographic scan of a patent proximal PAS-Port anastomosis (arrow).

 

Figure 4
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  		Fig 4. Computed tomographic scan of the occluded PAS-Port anastomosis (arrow).

 
Stenoses or occlusions were predominantly seen in the Symmetry device within two to nine months after surgery. The present study demonstrates that the PAS-Port device does not seem to be prone to this longer term complication. This difference in performance and outcome may be explained by a number of factors that differentiate the PAS-Port device from the Symmetry device. In contrast to the Symmetry device the PAS-Port system leaves the endothelium of the vein untouched and minimizes the amount of foreign material exposed to blood. The PAS-Port device presents a larger orifice especially in smaller vein grafts.

Lahtinen and colleagues [7] recently reported low patency rates for the PAS-Port device in a rather small series with only nine patients in the device group. They speculated that the theoretical takeoff angle at 90 degrees of the device may have had an impact on patency. This stands in contrast to excellent midterm patency observed in our series with a significantly higher number of patients enrolled. In our earlier series we were able to demonstrate by angiogram that after chest closure the takeoff angle in PAS-Port or hand-sewn anastomoses is not different [6]. Nonetheless, the manufacturer of the PAS-Port device emphasizes in the instructions for use the importance of placing the device on the anterior portion of the aorta for grafts to the right and on the concave surface of the aorta for grafts to the left territory.

The avoidance of clamping the aorta is seen as one of the key advantages of proximal connector devices in respect to a theoretical impact on neurologic outcome. Thus, embolic load should be decreased when using proximal connector systems; but in two trials the Symmetry device failed to reduce the amount of solid emboli evaluated by transcranial Doppler [20] or intraaortic filter [21]. To this day there are no data regarding neurologic outcome with the PAS-Port device. In the current study, the rate of postoperative delirium was lower in the PAS-Port-group but failed to reach statistical significance. In addition none of the patients in the PAS-Port group experienced a stroke or transitory ischemic attack compared with one patient in the hand-sewn group with a stroke. Currently the price may be prohibitive for routine use in many centers but given the potential for reducing neurologic complications, and maybe a higher patency rate (the study population in this study was to small to allow to reach a statistically significant result), the device may be cost effective and therefore may be more frequently used.

Further randomized trials are necessary to investigate these issues, particular in high risk subgroups such as patients with advanced aortic disease. Limitations of the present study are evaluation of patency by multislice CT scans and a significant lower follow-up rate in the hand-sewn-group. Angiogram is seen as the gold standard for assessing patency rates. But, as multislice CT scan is evolving rapidly and gaining more and more confidence, several studies reporting excellent sensitivity of almost 100% [22, 23] for severe stenosis and occlusion, especially when addressing the proximal site. Follow-up rate in the hand-sewn-group was significantly lower because of a higher rate of renal insufficiency after one year, despite equal distribution preoperatively (PAS-Port 21.6% vs hand-sewn 25%, p = 0.686). If creatinine exceeded a cutoff value of more than 2.0 mg/dL and the patient presented without angina (Canadian Cardiovascular Society class 0-1), the scheduled CT scan was cancelled. More patients in the hand-sewn-group declined follow-up CT scan, feeling well and probably being aware of not having been treated with any new technique. All patients were interviewed by telephone and all patients without CT follow-up were asymptomatic.

In summary, one year patency of the PAS-Port device is comparable with the conventional hand-sewn approach. Based on this experience we consider this product a safe and effective tool, especially in the field of OPBAB procedures when using vein grafts and in patients with aortic disease.


   Acknowledgments
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
References
 
This study was supported by a research grant from Cardiac Inc, Redwood City, CA.


   References
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 

  1. Guyton RA, McClenathan JH, Michaelis LL. A mechanical device for sutureless aorta-saphenous vein anastomosis Ann Thorac Surg 1979;28:342-345.[Abstract]
  2. Falk V, Gummert JF, Walther T. Anastomotic devices for coronary artery bypass grafting Expert Rev Med Devices 2005;2:223-233.[Medline]
  3. Traverse JH, Mooney MR, Pedersen WR, et al. Clinical, angiographic, and interventional follow-up of patients with aortic-saphenous vein graft connectors Circulation 2003;108:452-456.[Abstract/Free Full Text]
  4. Maisel WH. A device for proximal anastomosis of autologous coronary vein grafts Circulation 2005;112:1516-1518.[Free Full Text]
  5. Carrel TP, Eckstein FS, Englberger L, Berdat PA, Schmidli J. Clinical experience with devices for facilitated anastomoses in coronary artery bypass surgery Ann Thorac Surg 2004;77:1110-1120.[Abstract/Free Full Text]
  6. Gummert JF, Demertzis S, Matschke K, et al. Six-month angiographic follow-up of the PAS-Port II clinical trial Ann Thorac Surg 2006;81:90-96.[Abstract/Free Full Text]
  7. Lahtinen J, Biancari F, Ojala R, et al. Prospective, randomized study on the use of the Cardica PAS-Port aortic connector system in off-pump coronary artery bypass surgery Heart Surg Forum 2006;9:E568-E571.[Medline]
  8. Lipowski ZJ. Delirium: acute confusional statesOxford: Oxford University Press; 1990.
  9. Diagnostic and statistical manual of mental disorders, 3rd edition revised. Washington, DC: American Psychiatric Association; 1987.
  10. Edmunds Jr LH, Clark RE, Cohn LE, Grunkemeier GL, Miller DC, Weisel RD. Guidelines for reporting morbidity and mortality after cardiac valvular operations J Thorac Cardiovasc Surg 1996;112:708-711.[Free Full Text]
  11. Ferguson TB, Hammill BG, Peterson ED, DeLong ER, Groveret FL. A decade of change–risk profiles and outcomes for isolated coronary artery bypass grafting procedures, 1990-1999: a report from the STS National Database Committee and the Duke Clinical Research Institute Ann Thorac Surg 2002;73:480-490.[Abstract/Free Full Text]
  12. Hoff SJ, Ball SK, Coltharp WH, Glassford Jr DM, Lea 4th JW, Petracek MR. Coronary artery bypass in patients 80 years and over: is off-pump the operation of choice? Ann Thorac Surg 2002;74:S1340-S1343.[Abstract/Free Full Text]
  13. Hirose H, Amano A, Takahashi A. Off-pump coronary artery bypass grafting for elderly patients Ann Thorac Surg 2001;72:2013-2019.[Abstract/Free Full Text]
  14. Lev-Ran O, Braunstein R, Sharony R, et al. No-touch aorta off-pump coronary surgery: the effect on stroke J Thorac Cardiovasc Surg 2005;129:307-313.[Abstract/Free Full Text]
  15. Bergsland J, Hol PK, Lingås PS, et al. Intraoperative and intermediate-term angiographic results of coronary artery bypass surgery with Symmetry proximal anastomotic device J Thorac Cardiovasc Surg 2004;128:718-723.[Abstract/Free Full Text]
  16. Dewey TM, Crumrine K, Morley AH, et al. First-year outcomes of beating heart coronary artery bypass grafting using proximal mechanical connectors Ann Thorac Surg 2004;77:1542-1549.[Abstract/Free Full Text]
  17. 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]
  18. Gurbuz AT, Zia AA, Vuran AC, Cui H, Aytac A. Postoperative clopidogrel improves mid-term outcome after off-pump coronary artery bypass graft surgery: a prospective study Eur J Cardiothorac Surg 2006;29:190-195.[Abstract/Free Full Text]
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