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Ann Thorac Surg 2005;79:1732-1737
© 2005 The Society of Thoracic Surgeons

New technology

First Clinical Experience With the HEARTSTRING, a Device for Proximal Anastomoses in Coronary Surgery

Calin Vicol, MDa,*, Martin Oberhoffer, MDa, Georg Nollert, MDa, Sandra Eifert, MDa, Peter Boekstegers, MDb, Bernd Wintersperger, MDc, Bruno Reichart, MDa

a Department of Cardiac Surgery, Grosshadern Medical Center, Ludwig Maximilians University Munich, Munich, Germany
b Department of Internal Medicine I, Grosshadern Medical Center, Ludwig Maximilians University Munich, Munich, Germany
c Department of Radiology, Grosshadern Medical Center, Ludwig Maximilians University Munich, Munich, Germany

Accepted for publication May 3, 2004.

* Address reprint requests to Dr Vicol, Herzchirurgische Klinik, Klinikum Grosshadern, Ludwig Maximilians Universitüat Müunchen, Marchioninistrasse 15, 81377 Munich, Germany (E-mail: calin.vicol{at}med.uni-muenchen.de).


   Abstract
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 Abstract
Introduction
 Patients and Methods
 Device and Procedure Description
 Results
 Comment
 Disclosures and Freedom of...
 Footnotes
 References
 
PURPOSE: The HEARTSTRING is a device designed to enable the creation of a clampless hand-sewn proximal anastomosis.

DESCRIPTION: Seventy-six patients who underwent myocardial revascularization had 113 proximal anastomoses created by the HEARTSTRING. Fifty-five procedures were performed on cardiopulmonary bypass and 21, off pump.

EVALUATION: Of 114 intended proximal anastomoses, 113 (99.1%) were successfully performed using the HEARTSTRING. The conduits anastomosed proximal with support of the HEARTSTRING were in 92 cases saphenous veins and in 21 cases radial arteries. Mean time to perform a HEARTSTRING-supported anastomosis was 6.6 ± 1.2 minutes. One patient (1.3%) died postoperatively; the death was not device related. In 1 additional patient (1.3%), a stroke most likely due to air embolism occurred. Forty-nine patients (64.5%) underwent a predischarge coronary angiography (n = 20) or a contrast multislice computed tomography (n = 29). Of 76 grafts with a HEARTSTRING-supported proximal anastomosis, 74 (97.4%) were patent in these 49 patients.

CONCLUSIONS: Our initial clinical experience with the HEARTSTRING demonstrates safety, reliability, and ease of use. Side clamping of the ascending aorta can be avoided, potentially decreasing the incidence of neurologic complications.


   Introduction
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 Abstract
 Introduction
Patients and Methods
 Device and Procedure Description
 Results
 Comment
 Disclosures and Freedom of...
 Footnotes
 References
 
Side clamping of the ascending aorta during construction of proximal aorto-coronary bypass anastomoses may produce particulate cerebral emboli with adverse neurologic outcome [1]. To avoid this problem, devices were developed to perform clampless anastomoses. In the past 3 years, however, only two designs based on the same technology evolved to prototype tools and are described in clinical trials: the Symmetry Aortic Connector System (St. Jude Medical, St. Paul, MN) and the CorLink device (Bypass Ltd, Herzelia, Israel).

Recently a new anastomotic device, the HEARTSTRING Proximal Seal System (Guidant Corporation, Santa Clara, CA), facilitating the creation of a clampless hand-sewn coronary artery bypass-to-ascending aorta anastomosis was introduced into the market. We report here our initial experience with this device.


   Patients and Methods
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 Abstract
 Introduction
 Patients and Methods
Device and Procedure Description
 Results
 Comment
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 Footnotes
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Between April 2003 and January 2004, we performed 113 proximal coronary artery bypass anastomoses using the HEARTSTRING device in 76 patients. Indication to use the HEARTSTRING was a normal aortic wall morphology ascertained by palpation at the planned anastomotic site and saphenous veins or radial arteries as grafts. Preoperative patient characteristics are given in Table 1.


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  		Table 1. Preoperative Patient Data
 
Surgery was performed on cardiopulmonary bypass in 55 cases and off pump in 21 cases. Myocardial revascularization was performed as a reoperation in 3 cases. A total number of 207 grafts for 236 distal anastomoses were implanted. Graft material was the left internal thoracic artery (LITA) in 66 cases, right internal thoracic artery (RITA) in 23 cases, radial artery (RA) in 24 cases, and saphenous vein (SV) in 94 cases. The LITA was used "in situ" in 65 cases and as a free graft in 1 case. The RITA was used "in situ" in 9 cases and as a part of a T graft in 14 cases. The proximal graft connections are listed in Table 2. A graft-to-ascending aorta anastomosis was performed using the HEARTSTRING in 99.1% of the cases (n = 113). Mean number of HEARTSTRING-supported proximal anastomoses per patient was 1.5 ± 0.6 (range, 1 to 4). Target coronary arteries are listed in Table 3. Mean number of distal anastomoses per patient was 3.1 ± 1.1 (range, 1 to 6). Concomitant procedures are listed in Table 4. Data are presented as the mean ± SD.


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  		Table 2. Proximal Graft Connection
 

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  		Table 3. Distal Graft Connection
 

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  		Table 4. Concomitant Surgical Procedures
 

   Device and Procedure Description
Top
 Abstract
 Introduction
 Patients and Methods
 Device and Procedure Description
Results
 Comment
 Disclosures and Freedom of...
 Footnotes
 References
 
The HEARTSTRING Proximal Seal System consists of the seal, delivery device, and aortic punch (Fig 1). The seal is delivered into the aorta using a syringe-like tube with plunger. It provides a sealed region to facilitate the creation of a hand-sewn anastomosis. The first step of the procedure consists of loading the seal into the delivery device (Fig 2a). The seal is folded into a roll shape and introduced gently into the tube of the delivery device. Next, a hole into the ascending aorta is created using the punch (Fig 2b). Bleeding is controlled by covering the hole with a finger. The tube of the delivery device with the preloaded seal is introduced through the hole into the ascending aorta. Plunger depression deploys the seal (Fig 2c). After withdrawal of the delivery device (Fig 2d), the seal is completely deployed and held in place by a tension spring. If hemostasis is inadequate, fine tip suction helps to clear the anastomotic field. The anastomosis is performed using a running suture in a conventional manner (Fig 2e). We found the use of specially curved needles with a small radius (ACC-1, 6-0 Prolene; Ethicon Products, Norderstedt, Germany) extremely helpful to create the anastomosis. The last step of the procedure is the removal of the seal after completion of the anastomosis (Fig 2f). Light downward pressure with the thumb and forefinger will facilitate seal removal.



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  		Fig 1. Components of the HEARTSTRING proximal seal system. (a) Aortic punch. (b) Delivery device with partial deployed seal. (c) Deployed seal with stem and tension spring.

 


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  		Fig 2. Steps of the procedure using the HEARTSTRING proximal seal system. (a) Loading of the seal into the delivery device. (b) Creation of the anastomotic hole. (c) Seal partial deployment. (d) Seal complete deployment. (e) Creation of the anastomosis. (f) Removal of the seal.

 

   Results
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 Abstract
 Introduction
 Patients and Methods
 Device and Procedure Description
 Results
Comment
 Disclosures and Freedom of...
 Footnotes
 References
 
A HEARTSTRING-supported proximal hand-sewn anastomosis could be performed in 99.1% of the planned cases (n = 113). Twelve devices (9.6%) were not used because of gaps within the seal produced by rolling the edges of the seal. In 4 cases (3.5%), the procedure had to be repeated (using the same device) because of incomplete delivery of the seal. In 1 case, the surgeon stitched the seal while performing the anastomosis. Side clamping of the ascending aorta was necessary to redo the anastomosis in a conventional fashion. Eleven times (9.7%) an additional stitch was necessary because of minor bleeding that occurred through a leak at the side where the seal was removed. Mean time to perform a HEARTSTRING-supported proximal anastomosis was 6.6 ± 1.2 minutes (range, 4 to 12). Significant differences between SV and RA regarding difficulty or time to perform the anastomosis were not observed. All grafts were patent at the end of the procedure as proved by flow measurements. Mean flow for grafts with a HEARTSTRING-supported proximal anastomosis was 62.4 ± 44.7 mL/min and 55.4 ± 34.2 mL/min for the rest of the grafts. Postoperative complications are listed in Table 5. One patient died on the third postoperative day. This patient had a myocardial infarction postoperatively. Angiography showed a spastic LITA "in situ" to left anterior descending artery stenosis as the cause of myocardial ischemia. A SV graft with a HEARTSTRING-supported proximal anastomosis to a marginal branch was patent. Despite percutaneous coronary angioplasty and stenting of the left anterior descending artery stenosis, rapid and severe hemodynamic deterioration led to the patient's death.


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  		Table 5. Postoperative Complications
 
Forty-nine patients (64.5%) underwent coronary angiography (20 patients) or contrast multislice computed tomography (29 patients) before discharge. Of 76 grafts with a HEARTSTRING-supported proximal anastomosis, 74 (97.4%) were patent in these patients. Contrast multislice computed tomography showed occlusion of 2 SV grafts in 1 patient. All other grafts without a HEARTSTRING-supported proximal anastomosis were patent.


   Comment
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 Abstract
 Introduction
 Patients and Methods
 Device and Procedure Description
 Results
 Comment
Disclosures and Freedom of...
 Footnotes
 References
 
Hand-sewing using a running suture is the gold standard to create a vascular anastomosis because it is effective, reproducible, and inexpensive. However, manual dexterity and a certain learning curve are necessary. The need for simplifying creation of anastomoses led to an extensive research to find an alternative to suture for a facilitated anastomosis [1].

Creating a proximal anastomosis is, in current practice, usually easier than creating a distal one. However, developments of anastomotic devices show the contrary. By the end of 2001, 112 patents for distal coronary anastomoses had been published, 57 of which were truly new applications [2]. Four categories of distal anastomotic devices may be distinguished: devices using micromechanical tissue bonding; laser-assisted vascular anastomotic techniques; adhesive bonding of graft and target coronary artery; and magnetic coupling. For proximal anastomotic devices, only one method based on semiautomated mechanical bonding was used. This method creates end-to-side anastomoses between SV grafts and the aorta using nitinol connectors. Two devices were developed and studied in clinical practice: the Symmetry Aortic Connector System and the CorLink device. Since the Symmetry device received European Community (CE) market and Food and Drug Administration approval in May 2001, more than 30,000 systems have been used worldwide. After encouraging initial results [3, 4], 6-month data showed a patency of 86.6% [5]. In a prospective randomized study comparing the Symmetry-supported anastomotic procedure with the conventional suture technique, a 38% stenosis incidence after using the Symmetry device versus 0% for hand-sewed anastomoses was demonstrated [6]. Because the observed rate of stenosis was not acceptable, the authors stopped further clinical use of the device. Two recent papers report good short-term follow-up patency rates after using the CorLink device [7, 8]. However, the company did not submit for CE market approval until now, and the tool is no longer available for clinical trials. Loading the vein onto the delivery system may produce intimal lesions and later intimal hyperplasia. A 90-degree take-off angle of the graft out of the ascending aorta may cause kinking and graft occlusion in case an unsuitable site for proximal anastomosis is chosen. The potential role of nitinol in the progression of neointimal hyperplasia needs to be further investigated, even though this material had a successful history of use in cardiovascular applications [4].

Atheroembolism from the calcified ascending aorta has been recognized as a major issue in patients undergoing surgical myocardial revascularization [9]. Although the risk of atheroembolism from instrumentation of the atherosclerotic ascending aorta has been well documented, there has been little success in modifying surgical techniques to minimize this potential complication. Modifications included avoidance of cardiopulmonary bypass (off-pump myocardial revascularization), use of intraluminal balloon catheters instead of rigid aortic clamps, use of padded aortic clamps, cannulation distal to the left carotid artery, or cannulation of the femoral artery. All these procedures do not avoid side clamping of the ascending aorta while creating proximal graft anastomoses. The HEARTSTRING is a simple device facilitating the performance of a clampless hand-sewn proximal anastomosis. The rate of neurologic events was low during our experience using the HEARTSTRING. There was 1 stroke, in an 83-year-old woman, after the first use of the device in combination with a blower mister in our department [10]. We do not know whether the embolic event was related to the use of the HEARTSTRING in combination with a blower mister, because other mechanisms such as cross clamping or cannulation of the atherosclerotic ascending aorta may have been responsible for the stroke. However, we strongly recommend the use of a fine-tip suction instead of a blower mister. One transient ischemic attack occurred in a patient on the fourth postoperative day concomitant with acute atrial fibrillation. The rhythm disturbance was believed to be the cause of the neurologic event. Three patients experienced neurobehavioral dysfunction without evidence of focal injury. In these patients, myocardial revascularization was performed on pump, and cardiopulmonary bypass was suspected as the cause of the dysfunction. Recovery was complete in all cases.

Using the HEARTSTRING with RA-to-ascending aorta is also feasible. We did not experience any difficulty caused by a too large hole in the aortic wall created with the punch. All proximal radial artery graft anastomoses were patent and hemostatic at the end of the procedure.

An important advantage of performing proximal graft anastomoses supported by the HEARTSTRING is the simplicity of the procedure. No loading of the graft is necessary. Loading the seal, punching the aorta, and deploying the seal is a short procedure lasting 1 to 2 minutes. Time to suture the anastomosis was in our experience 6.6 ± 1.2 minutes. Contrary to other connection devices, the HEARSTRING allows the choice of performing distal or proximal anastomoses first.

In 11 cases, an additional stitch was necessary because of minor bleeding. None of these caused a narrowing or occlusion of the anastomosis as demonstrated by postoperative angiography or contrast multislice computed tomography.

Device failure at the time of loading the seal into the delivery device was an important issue. At the beginning of our experience, we observed gaps within the seal in 12 cases. These gaps occurred when rolling the edges of the seal to be loaded. Respecting the company's recommendations, we did not use damaged devices. To avoid this problem, we submerged the seal in lukewarm saline solution some minutes before loading, which helped but did not avoid gaps in all cases. In our late experience, we also used devices with small gaps (only half of the circumference of the seal) and experienced satisfactory hemostasis while creating the anastomosis.

In 1 case, the surgeon stitched the seal while performing the anastomosis and realized it as he tried to remove the seal. In that case, the surgeon decided to side clamp the aorta. The suture and the seal were removed without complications, and the anastomosis was performed in conventional fashion.

Four times the seal slipped out through the anastomotic hole after deployment. We suspect a faulty surgical technique or a too low systolic pressure did not allow the seal to unfold. In all these cases, we could reload the seal into the delivery device after pushing back the end of the spring into the tube of the delivery device. The procedure was repeated successfully in all cases.

In 2 patients, a reexploration for bleeding was necessary. The source of the bleeding was not the HEARTSTRING-supported proximal anastomosis. Two myocardial infarctions occurred in territories that were not supplied by grafts with HEARTSTRING-supported hand-sewn anastomosis.

Patency for HEARTSTRING-supported hand-sewn proximal anastomoses was 97.4% (74 of 76). Two SV graft closures confirmed by contrast multislice computed tomography occurred in the same patient. In this particular case, a colon cancer was diagnosed. Concomitant lung emboli supported the suspicion of a coagulopathy accompanying a paraneoplastic syndrome.

A disadvantage of the device is cost, which in Germany represents 33 times the price for a 6-0 polypropylene suture. Another issue with the HEARTSTRING is that time to perform the anastomosis is not shorter than for a hand-sewn anastomosis. Device failure caused by gaps within the seal can be reduced by submerging the seal before loading into lukewarm saline and gently folding and inserting the seal into the delivery device.

The HEARTSTRING device offers a safe, easy, quick, and reproducible option to connect SV and RA grafts to the ascending aorta. Side clamping is avoided, and it is hoped that may result in a decreased incidence of embolic events and neurologic complications. In contrast to the alternate connection devices, loading of the graft is not necessary, thus avoiding additional manipulations and potentially reducing the risk of intimal lesions. No additional foreign material other than the suture is part of the anastomosis, thereby avoiding the necessity of antiplatelet therapy.


   Disclosures and Freedom of Investigation
Top
 Abstract
 Introduction
 Patients and Methods
 Device and Procedure Description
 Results
 Comment
 Disclosures and Freedom of...
Footnotes
 References
 
The clinical study for the evaluation of the HEARTSTRING device was not supported financially by the Gfinancialuidant company. The devices were not donated by the company, they were acquired by our hospital at the regular market cost in Germany. None of the authors have a financial agreement with the Guidant company. All authors had full control of the design of the study, methods used, outcome parameters, analysis of the data, and production of the written report.


   Footnotes
Top
 Abstract
 Introduction
 Patients and Methods
 Device and Procedure Description
 Results
 Comment
 Disclosures and Freedom of...
 Footnotes
References
 
Disclaimer The Society of Thoracic Surgeons, the Southern Thoracic Surgical Association, and The Annals of Thoracic Surgery neither endorse nor discourage use of the new technology described in this article.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Device and Procedure Description
 Results
 Comment
 Disclosures and Freedom of...
 Footnotes
 References
 

  1. Roach GW, Kanchuger M, Mangano CM, et al. Adverse cerebral outcomes after coronary artery bypass surgeryMulticenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators. N Engl J Med 1996;335:1857-1863.[Medline]
  2. Scheltes JS, van Andel CJ, Pistecky PV, Borst C. Coronary anastomotic devicesblood-exposed non-intimal surface and coronary wall stress. J Thorac Cardiovasc Surg 2003;126:191-199.[Abstract/Free Full Text]
  3. Eckstein FS, Bonilla LF, Englberger L, et al. Minimizing aortic manipulation during OPCAB using the Symmetry aortic connector system for proximal vein graft anastomoses. Ann Thorac Surg 2001;72:S995–8..
  4. Antona C, Scrofani R, Lemma M, et al. Assessment of an aortosaphenous vein graft anastomotic device in coronary surgeryclinical experience and early angiographic results. Ann Thorac Surg 2002;74:2101-2105.[Abstract/Free Full Text]
  5. Mack MJ, Emery RW, Ley LR, et al. Initial experience with proximal anastomoses performed with a mechanical connector Ann Thorac Surg 2003;75:1866-1871.[Abstract/Free Full Text]
  6. 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]
  7. Calafiore AM, Bar-El Y, Vitolla G, et al. Early clinical experience with a new sutureless anastomotic device for proximal anastomosis of the saphenous vein to the aorta J Thorac Cardiovasc Surg 2001;121:854-858.[Abstract/Free Full Text]
  8. Riess F-C, Helmold H, Hilfer I, et al. Clinical experience with the CorLink device for proximal anastomosis of the saphenous vein to the aortaa clinical, prospective, and randomized study. Heart Surg Forum 2002;5:345-353.[Medline]
  9. Bar-El Y, Goor DA. Clamping of the atherosclerotic ascending aorta during coronary artery bypass operationsits cost in strokes. J Thorac Cardiovasc Surg 1992;104:469-474.[Abstract]
  10. Nollert G, Oberhoffer M, Reichart B, Vicol C. Combination of the HEARTSTRING proximal seal system with a blower mistera possible source of gas emboli. J Thorac Cardiovasc Surg 2003;126:1192-1194.[Free Full Text]



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