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Eur J Cardiothorac Surg 2005;27:876-881
© 2005 Elsevier Science NL

First clinical results with a 30° end-to-side coronary anastomosis coupler

^a Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Arnold-Heller-Str. 7, 24105 Kiel, Germany
^b Department of Thoracic and Cardiovascular Surgery, Medical School Hannover, Hannover, Germany

Received 29 September 2004; received in revised form 16 December 2004; accepted 26 December 2004.

^* Corresponding author. Tel.: +49 431 597 4400; fax: +49 431 597 4402. (E-mail: aboening{at}kielheart.uni-kiel.de).

	Abstract

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion 5. Study limitations Appendix A. Inclusion criteria Appendix B. Exclusion criteria Appendix C. Conference... References

 
Objective: The purpose of this study is to evaluate the safety and efficacy of a novel 30° end-to-side coronary anastomotic coupler (Converge Medical, Inc., Sunnyvale, CA) that facilitates a non-penetrating, sutureless vein graft to coronary artery anastomosis. Material and methods: The Coupler utilizes a set of concentric mating frames approximating adjacent vessel tissue allowing for biological healing of the anastomosis. The frames are manufactured from Nitinol, a nickel titanium super-elastic metal alloy. The Nitinol frames attach the bypass graft to the coronary artery in a 30° end-to-side configuration. Between November 2002 and March 2003 a total of 46 patients (44 male) with a mean age of 63.6±7.5 years were admitted for coronary artery revascularization and included in the study. The mean LVEF was 60.6±12.4%. Results: Thirty-three patients were successfully treated with the Coupler. Nine patients did not meet the intraoperative inclusion criteria, and were excluded from the study due to small (2.0mm) or severely calcified coronary vessels, or small vein grafts. Hemostasis could not be achieved with the Coupler in 3 patients, and in one patient the graft flow measured intraoperative was low. In these instances the Coupler was removed and the anastomosis was sutured without complication. Average mean flow rate using transit time method through the Coupler attached bypasses was 54±26ml/min. In a control angiography 2 months after surgery, 29 (96.7%) of the 30 connector grafts were patent. One stenosis of 50% occurred on the site of a connector anastomosis. Angiographic patency assessments for 81 hand sewn grafts revealed 73 (90.1%) patent grafts. Conclusion: Initial results indicate that the Converge Coupler can be used to create a safe and effective 30° vein graft to coronary artery anastomosis under suitable conditions.

Key Words: Coronary artery bypass surgery • Facilitated anastomosis • Sutureless anastomotic device • Revascularization • Mechanical connector

	1. Introduction

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion 5. Study limitations Appendix A. Inclusion criteria Appendix B. Exclusion criteria Appendix C. Conference... References

 
While sutured coronary anastomoses still represent the standard of surgical treatment, the potential role of anastomotic devices still has to be defined. However, handsewn anastomoses may have a high variability between surgeons and procedures. Factors such as skill of the surgeon, coronary anatomy, progression of disease, procedural access and exposability, and instrumentation may basically contribute to the level of quality of an anastomosis. Anastomotic devices could introduce a more standardized technique with less tolerance in quality.

Over the last years, there have been major industrial developments to create a mechanical anastomosis between a saphenous vein graft and the coronary artery [1–6] or between a saphenous vein graft and the aorta [7–9]. A nitinol connector that facilitates a non-penetrating, sutureless vein graft to coronary artery anastomosis, developed by Converge Medical, Inc., Sunnyvale, CA, is intended to create an end-to-side 30° elliptical coronary anastomosis. The coronary artery coupler (CAC) is an anastomotic clip that relies on a set of concentric mating frames, which clamps vessel tissues together to enable healing. Aim of this study was to evaluate safety and efficacy of this connector in humans after initial testing in an animal model.

	2. Methods

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion 5. Study limitations Appendix A. Inclusion criteria Appendix B. Exclusion criteria Appendix C. Conference... References

 
In a two-center, prospective, non-randomised, open study, the safety and efficacy of the end-to-side 30° vein graft—to—coronary artery anastomosis coupler was investigated.

After approval of each centre's ethics committee, enrolled patients received a full and adequate verbal and written information and signed the informed consent form prior to their inclusion in the study. Between November 2002 and march 2003 a total of 46 patients (44 male) with a mean age of 63.6±7.5 years and a mean LVEF of 60.6±12.4% scheduled for a CABG procedure were screened (for inclusion criteria see Appendix B). The 46 patients enrolled in the study were candidates for isolated CABG via a median sternotomy and scheduled for at least one non-LAD saphenous vein bypass graft with a target coronary artery stenosis 50% via angiography and 2mm inner diameter verified intraoperatively by probing the coronary artery. The patients' cardiovascular medical history is summarized in Table 1. All patients were operated on using standard cardiopulmonary bypass techniques and cardiac arrest, receiving 3.5±0.9 anastomoses per patient. One anastomosis in each patient was performed with the nitinol coupler, all other grafts were handsewn. Blood flow over the mechanical anastomosis and—in most patients—also over the handsewn bypass grafts was measured after ECC using the transit time method with a 3- or 4-mm ultrasonic flow probe (HT-313 Flowmeter, Transonic Systems Inc).

View larger version (96K): [in this window] [in a new window]   Fig. 1. Mounting the vein graft between the inner and outer frames of the nitinol coupler.

View larger version (82K): [in this window] [in a new window]   Fig. 2. The coupler loaded to the saphenous vein and to the delivery tool. The system is ready for deployment.

View larger version (60K): [in this window] [in a new window]   Fig. 3. Mechanical 30° end-to-side connection between an saphenous vein graft and a diagonal branch.

Clinical success of the procedure was defined as successful insertion of the coupler into the target vessel and patency of the coupler at the time of postoperative angiogram.

	3. Results

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion 5. Study limitations Appendix A. Inclusion criteria Appendix B. Exclusion criteria Appendix C. Conference... References

 
Eight patients were excluded intraoperatively due to vein graft diameter <3mm, target coronary artery diameter <2mm, or heavy calcification of the target coronary artery. One patient was enrolled, but not implanted because the investigator decided before coupling not to implant the device due to the fragility of the coronary vessel; the anastomosis was hand sutured.

In three cases the coupler was removed due to bleeding from the lateral aspect or the heel of the anastomosis. In one case, the blood flow in a coupler graft to an obtuse branch, which was occluded in the preoperative angiogram, was unacceptably low (<5ml/min). The anastomosis was removed and hand sutured, but the graft flow was still low, probably due to poor run off.

In these instances the coupler could be easily removed using a special tool without damage for the coronary artery, and the anastomosis could be handsewn without complication.

The 33 remaining patients were successfully treated with the coupler, all standard targets for coronary revascularisation could be reached. In 4 cases, minor anastomotic bleeding could be treated by slightly changing the position of the coupler within the anstomosis or with the use of fibrin glue. Procedural times and the time needed for loading and deployment of the coupler are displayed in Table 2, flow measurement results in Table 3.

Three of 33 patients successfully treated with the coupler were not willing to have the scheduled postoperative angiography. In the remaining 30 patients, 29 of the 30 coupler grafts were patent 2 months after surgery. One stenosis of 50% occurred on a coupler anastomosis. These two patients were asymptomatic: In each the patient with the occluded and in the patient with the stenosed coupler anastomosis, 4 other grafts were patent. Angiographic patency assessments for 37 hand sewn venous grafts showed 30 (81.1%) patent grafts. All four radial artery grafts and 39 of 40 (97.5%) ITA grafts were patent. A representative angiogram of a venous graft with a coupler anastomosis to a 1st obtuse marginal branch is shown in Fig. 4.

View larger version (147K): [in this window] [in a new window]   Fig. 4. Postoperative Angiogram of CAC Anastomosis of a SVG Graft to a 1st Obtuse Marginal.

	4. Discussion

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion 5. Study limitations Appendix A. Inclusion criteria Appendix B. Exclusion criteria Appendix C. Conference... References

Our results do not show superior graft patency rates with the new coupler compared with handsewn anastomoses. In this study, a patient did not serve as his own control for comparison of patency rates between couplers and handsewn grafts: The very good coupler patency rate (96.7%) and the acceptable sutured vein graft patency rate (81.1%) at the 2 months follow-up cannot be compared, because the coupler grafts were done on bigger coronary arteries (mean diameter 2.1±0.2mm) with a better runoff (bypass flow see Table 3) compared to the handsewn grafts (mean diameter 1.5±0.3mm). A randomized, prospective trial would be needed to compare graft patency rates with and without coupler. Reported vein graft patency rates vary between 85.2% [10], 91% [11] and 95% [12] at 3 months, 81% [13] and 88.3% at 1 year [14], and 95% at 5 years [15] for vein grafts sutured on ECC with the use of aortic clamping and cardioplegia.

During this study, we tried to revascularize the most important vessels with arterial grafts and the less important vessels with venous grafts. The bigger coronary arteries were supplied with a coupler graft, the smaller coronary arteries with a handsewn vein graft. Therefore, it is not astonishing that handsewn vein grafts to small (1.5mm and less) coronary arteries with a suboptimal runoff (see Table 3) have a patency rate not every cardiac surgeon dreams of. With a 88% vein graft patency (59/67 vein grafts), our results are comparable to published results from other series [10–15].

The role of a blood-exposed non-intimal surface (BENIS) of an anastomosis has been discussed by Scheltes et al. [16]: While in a conventionally sutured anastomosis BENIS could be nearly avoided (1.3mm²), different anastomosis devices presented BENIS from 4.3 to 80mm². The BENIS of the investigated coupler in this study is 22mm². Theoretically, a higher amount of foreign material leads to a higher degree of intimal hyperplasia, which is known to be a problem for coronary stents. The difference of the studied coupler to a stent is, that the coupler is inserted into the most healthy and not the most diseased part of the coronary vessel and that the coupler does not cover the whole circumference of the coronary wall. To investigate the medium—and long term effects of the Converge coupler, it was tested in animal experiments up to 90 days and showed a complete endothelialization without intimal hyperplasia.

Potential advantages as well as disadvantages with devices for facilitated anastomoses have been described in detail by Carrel et al [17]. There are flow advantages of a 30° end-to-side anastomosis like the coupler used in this study compared to anastomoses with an increased angle [1,2]: Increasing the angle of a end-to-side anastomosis leads to increased shear stress on the vascular bed across from the toe and to increased flow separation near the toe [18].

In two reports regarding the stainless steel clip system of St Jude Medical/Anastomotic Technology Group, the Bern University Hospital group [2,6] describes a different distal sutureless anastomotic device consisting of an expandable clip mounted on a balloon catheter. The angiographic patency was similar to the CAC system: 11/12 device anastomoses (first generation) were patent after 3 months, 7/10 device anastomoses (second generation) were patent after 6 months.

After different reports of failures with the SJM aortic-vein graft connector [19,20], most surgeons are sceptical about couplers and long-term patency of connector-dependent grafts. This led us to a careful evaluation of the coupler grafts' patency as early as 2 months after the procedure in this first series. Because the evaluation of the coupler function over a longer period of time is essential, other multicenter trials evaluating this coupler's patency rates at 6 and >15 months are currently on the way.

The advantages of an anastomotic device which is able to shorten the anastomosis time considerably are theoretically most obvious in off-pump or beating heart surgery, because hemodynamic deterioration due to cardiac displacement would be effective only for a very short time. Though we have no practical knowledge about use of the studied coupler in off-pump surgery, we would like to point out that an optimal visualisation of the coronary vessel and an optimal stabilisation of the heart is essential also for this kind of mechanical anastomosis. Therefore, the use of exposure tools and stabilization devices cannot be avoided when creating a coupler anastomosis.

As in this report, also in other studies [1,2,6] superiority of facilitated anastomoses over conventional anastomoses could not be shown. Data comparing anastomosis times for conventional or sutureless anastomoses are still lacking.

	5. Study limitations

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion 5. Study limitations Appendix A. Inclusion criteria Appendix B. Exclusion criteria Appendix C. Conference... References

 
Due to the rigid intraoperative inclusion criteria (see Appendix B and C) caused by the suitability of this first generation of the coupler only for coronary arteries with a diameter >2mm and for veins with a diameter >3mm, a large number of patients had to be excluded from the study.

The development of couplers for either vein grafts or IMA grafts to smaller coronary arteries is currently evaluated in animal models and shows promising early results.

Bleeding from the anastomosis site was regarded as technical failure, 3 couplers had to be removed and 4 others showed minor bleeding which could be treated effectively. As we were very critical about anastomosis leakage, the necessity of additional stitches during this investigation was a reason to remove the coupler from the anastomosis. Reasons for bleeding included technical errors during loading and coupling of the device as well as a too large opening of the coronary artery during insertion. Because the results of this study include the full learning curve of 4 surgeons, it is possible that the rate of anastomotic leakages can be reduced with more experience.

We conclude from the results of this first study that the implantation of a CAC device can be done safely and effectively. In cases of technical failure, the CAC can be removed without damage for the coronary artery. It can be speculated that a sutureless anastomotic device like the CAC could facilitate off-pump or endoscopic coronary bypass surgery. Before this can be clinically evaluated, CAC anastomoses have to prove a patency rate at least similar to that of handsewn anastomoses.

	Appendix A. Inclusion criteria

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion 5. Study limitations Appendix A. Inclusion criteria Appendix B. Exclusion criteria Appendix C. Conference... References

 
Preoperative inclusion criteria:

Patient between 35 and 80 years old.

Patient agrees to participate and signs the consent form.

Patient agrees to follow-up evaluation.

Patient has no known contraindications for follow-up angiography.

Patient is a candidate for isolated CABG via a median sternotomy and scheduled for at least one non-LAD saphenous vein bypass graft.

Target coronary artery stenosis >50% via angiography.

Intraoperative inclusion criteria:

Connector-coupled saphenous vein graft has:

– inner diameter of 3.0–4.0mm

– distal segment free of ligating clips or suture ligatures for portion that enters through the outer frame

– sufficient length to cut off the connector in case of conversion to sutured anastomosis

– target coronary artery >2mm in diameter

– proximal aortic anastomosis on the connector-graft is handsewn and provides solely flow to the connector graft

	Appendix B. Exclusion criteria

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion 5. Study limitations Appendix A. Inclusion criteria Appendix B. Exclusion criteria Appendix C. Conference... References

 
Preoperative exclusion criteria:

Patient does not sign the informed consent form.

Patient is participating in a clinical investigation of another dvice or drug.

Patient has history of cerebrovascular disease.

Patient has renal insufficiency (creatinine <3.0mg/dl or requires dialysis).

Patient has left ventricular ejection fraction <25%.

Patient has history of malignant ventricular tachyarrhythmia, sustaind ventricular tachycardia, or ventricular fibrillation leading to cardiac arrest.

Patient has a contraindication to an antiplatelet therapy that includes aspirin and clopidogrel, e.g. concomitant coumadin administration.

Patient has had a previous cardfiac surgical procedure,

Female patient pregnant or with childbearing potential who does not use adequate contraception or who is breastfeeding.

Patient is HIV positive or has hepatic failure.

Patient has hemodynamic instability that requires inotropic support or mechanical assist device.

Patient has allergy to nickel.

Intraoperative exclusion criteria:

Target coronary artery is severely calcifeid or contains soft atheroma anteriorly at the anastomosis site, within 2mm proximally from the heel and 4mmm distally from the toe.

Connector-graft is a Y-graft.

Connector graft is a sequential graft.

	Appendix C. Conference discussion

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion 5. Study limitations Appendix A. Inclusion criteria Appendix B. Exclusion criteria Appendix C. Conference... References

 
Dr P. Sergeant (Leuven, Belgium): Can you comment on the comparison with the hand sewn not being advisable?

Dr Sergeant: If you remove the device in case of failure of the device, of deployment or mismatch, what kind of section do you have to remove from your graft material? Are we talking about just an oblique resection or are we talking about having to remove the complete section?

Dr Boening: You remove the complete coupler. There is a specific removal tool which you need to deflect the coupler again so that you can easily take it out. There is a possibility of lengthening the incision in the coronary artery a little bit, but you can easily hand suture that. The vessel is not destroyed.

Dr D. Ross (Edmonton, Alberta, Canada): What is the cost of that device?

Dr Boening: Actually I cannot answer this question because we didn't buy it as it was a study device. If you look at other devices, you possibly have an idea how much the studied device will cost, too.

Dr V. Subramanian (New York, New York): This is a very elegant device. The only question I have is just like when you talk about OPCAB, what is the price you pay for conversion, is there any price you pay for those where you didn't implant? What was the graft patency in those four patients you had who could not be successfully implanted because of the difficulty? Do we do any damage to that area that will influence your outcome? That is very important.

Dr Boening: We didn't see damage in the coronary vessel besides this very small lengthening of the incision in the anastomosis, and all the grafts that were hand sewn after removal of the coupler were patent.

Dr G. Mani (New Delhi, India): I am just wondering how would you load this on a pedicled internal mammary? Did I miss something?

Dr Boening: This is one of the next studies which will start in a few months where we have to create a solution for getting the coupler into a mammary artery within the operative field. But I think the company has a solution there.

Dr D. Baykut (Basel, Switzerland): You recommend a similar management like the intravascular, intracoronary stent in this device. Are you planning new intracoronary angiography in 120 days or six months in those patients you control now?

Dr Boening: It is planned and is scheduled already, and the first 15 months’ data we have is that we have had five patients back after 15 months and all the connector anastomoses were patent, in fact. You said that we do it similar to cardiologists stents, but there are two big differences: first, we look at the most healthy part of the vessel, cardiologists look at the worst part of the vessel, and second, this coupler does not cover the whole circumference of the coronary artery like a stent does.

Dr M. Ahmed (Baghdad, Iraq): You said during the discussion that there is no way to compare between the device and the hand sewn, but when Mr. Subramanian asked you about after the removal of this device, you said everything is good and we suture it and it is patent. I think this is a comparison.

Dr Boening: I don't think it is a comparison. I think it is asking after the fate of the coronary artery after taking out the coupler.

	Footnotes

 
Presented at the joint 18th Annual Meeting of the European Association for Cardiothoracic Surgery and the 12th Annual Meeting of the European Society of Thoracic Surgeons, Leipzig, Germany, September 12–15, 2004.

	References

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion 5. Study limitations Appendix A. Inclusion criteria Appendix B. Exclusion criteria Appendix C. Conference... References

 

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Andreas Boening Jochen T. Cremer Uwe Klima Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Boening, A. Articles by Klima, U. Search for Related Content PubMed PubMed Citation Articles by Boening, A. Articles by Klima, U. Related Collections Coronary disease Minimally invasive surgery