NEW TECHNOLOGIES FOR FACILITATED ANASTOMOSES IN CORONARY ARTERY

BYPASS SURGERY
Duško G. Nežić, MD, PhD, FETCS, Aleksandar M. Knežević, MD, BSc, Miomir Đ. Jović, MD,
PhD, Ljiljana-Laušević Vuk, MD, BSc, Slobodan V. Mićović, MD, Ivan C. Stojanović, MD.
„Dedinje“ Cardiovascular Institute, Belgrade, Serbia
Coronary artery bypass grafting (CABG) for advanced coronary artery disease (CAD) has
become one of the most common operation (about 1 000 000 cases per year [1]) performed worldwide.
In order to improve patient outcome and decrease the complications during post-operative recovery, the
new surgical strategies were developed, focusing on less invasive approaches to cardiac surgery. The
simple logic of minimally invasive coronary surgery (MICS) is to perform the „classical“ cardiac
operation, but to avoid one or more of the 3 maneuvers responsible for the „invasiviness“ of the
procedure. These three maneuvers include sternotomy, cardiopulmonary bypass (CPB) and aortic
manipulation. Recent developments in MICS have been driven by the introduction of new technologies
(coronary stabilizer systems, cardiac positioning vacuum-assisted devices, and telemanipulative
systems) which facilitate precise surgical maneuvers on the beating heart as well as the construction of
total endoscopic beating-heart coronary anastomosis. Nonetheless, a limiting factor in the broader
adoption and further development of these procedures has been performing hand-sewn anastomoses in
confident space, on a beating heart, or both. A need exists for automated anastomotic technology,
which would enable the creation of rapid, precise, and reliable distal anastomoses on the beating heart
with limited exposure, as well as easy construction of proximal anastomoses avoiding a partial
occlusion clamp on the ascending aorta. Devices used to facilitate these procedures are described.

1. DEVICES FOR PROXIMAL ANASTOMOSIS

Interest in facilitating off pump coronary artery bypass (OPCAB) grafting and endoscopic
CABG has led to development of quick-connet devices. Due to its simplicity, the first goal has been
saphenous vein – aortic anastomosis. A proximal conector can decrease the procedure time and
hopefully decrease atherosclerotic embolization (avoiding partial occlusion clamp on the ascending
aorta during proximal anastomosis). Most of the devices employ a nitinol-based metal. One of the most
frequently used proximal devices is SymmetryTM Aortic Connector System (SACS). More than 40000
SACS have been used worldwide since receiving CE market and FDA approval in 2001. The connector
is selected by vein graft diameter. The vein is slid over a transfer sheet that facilitates the loading
process on the release tube (figure 1.). The system uses a unique rotating blade that creates a perfectly
round hole in the aortic wall. Hemostasis is perfect and instantaneous. Six months after application
animal testing showed no intimal hyperplasia but only a thin layer of neointima covering the device.

Figure 1.
(A) Proximal SACS – introduction of the delivery instrument is trough the proximal end of the
graft.
(B) – constructed side-to-side anastomosis with the proximal end of the graft being clipped.
Several publications have been presented [2, 3], but there is no consistent information about
patency rate reported (due to small number of reassessed grafts).
PAS-PortTM System has recently achieved European approval to be used as proximal
anastomotic device (figure 2.).
 Figure 2. Inside view of the device from inside (human cadaver aorta)
This product consist of a single tool that allows the surgeon to perform aortotomy and the
implant deployment with the single action. This implant is made of stainless steel, thus it has
significant advantage that the deployment results in firm attachment of the device to the aorta. This
system (only one size) is compatible with vein grafts from 4-6 mm of width, and aortas with more than
18 mm of outher diameter. A clinical trial has recently been completed for 50 implants in 47 patients,
with angiographically confirmed vein graft patency rate of 100% at discharge and 87% after 6 months
[4].

2. DEVICES FOR DISTAL ANASTOMOSIS

In the past, coronary anastomoses have been performed using running and, occasionally,
interrupted non-resorbable sutures. The ST. Jude Medical ATG coronary connector system is part of a
family of connectors that are made out of stainless steel. It was developed recently to facilitate the
creation of a vein graft-to-coronary anastomosis for CABG. Connector is mounted on balloon catheter
that, when pressurized, expand the device and create the anastomosis instantaneously (figure 3.).

Figure 3. Inflation of the balloon expand the device which connects the two vessels.
It produces a round anastomosis that matches the internal diameter of the target coronary
artery. Anastomoses are performed in a side-to-side fashion and the distal end of the graft is then
ligated (figure 4.), similarly allowing side-to-side anastomosis in a sequential graft in future. Coronary
connector creates a coronary anastomosis within minimal time and with minimal training requirements.
It offers a valuable alternative procedure to the standard suturing technique, not only for coronary
artery bypass grafting but also for its potential use in peripheral vascular procedures. Regretfully, the
recently published controlled, randomized study [5] didn't confirmed the acceptable quality of
connector system made distal anastomoses (26% of occluded anastomoses done with connector versus
0% of occluded hand-made anastomoses at 6-months follow-up).

Figure 4.completed anastomosis with the distal vein end tied.

Another device, a nickel-titanium coronary stent covered with polytetrafluoroethylene (PTFE)
was used to connect the internal thoracic artery (ITA) to the left anterior descending coronary artery
(LAD). The sleeve (stent) of the graft connector is placed inside the target coronary vessel. The
memory metal exerts a radial force that tends to open the sleeve, thus fixating the connector inside the
coronary artery. The conduit (ITA) is than attached to the side of the stent's branch (so called „tower“ –
figure 5.).

Figure 5. The ITA is introduced and fixed into the „tower“ of the graft connector
A feasibility study was performed with promising results [4].
Recently, the Cardiac C-Port Anastomotic System (CCPAS) has been introduced to facilitate
saphenous vein graft-to-coronary artery anastomoses. The CCPAS allows rapid automated distal
coronary anastomoses by integrating all the functions necessary for completing the anastomosis. A
compliant, angled, end-to-side anastomosis is performed by automatically placing eight individual clips
and creating an arteriotomy with the push of a button (figure 6.). A multicentar prospective clinical trail
[6] have recently confirmed excellent 6 months angiographic patency of 92.1% (82/89).

Figure 6. The view at the C-Port cartridge and anvil. The anvil is 1 mm in diameter and has
incorporated an arteriotomy knife. The cartridge contains eight clips.
The magnetic vascular positioner (MVP) system consists of six magnetic clips mounted on
two delivery devices. Each delivery device is preloaded with one intravascular and two extravascular
magnetic clips. One delivery device is used to create an anastomotic port in the graft (the saphenous
vein or an arterial conduit) by applying one magnetic clip inside and two outside the anastomotic
incision. The other delivery device forms an identical port at the selected anastomotic site on the target
coronary artery. As the two ports are brought together, the clips' magnetism causes coupling of the two
ports, creating the anastomosis with an effective anastomotic area of 6.0 mm2 (figure 7.).

Figure 7. The stepwise completion of a MVP anastomosis.

The MVP is available in two sizes: small device size (model 6150) is intended for vessels with
an internal diameter of 1.5-2.0 mm. Bigger device size (model 6200) is for vessels with an internal
diameter of more than 2.0 mm. Criteria to use the MVP request target artery with high-grade stenosis,
with diameter of at least 1.5 mm, and no atherosclerotic plaque at the site of the MVP implantation. In
such circumstances the mean MVP anastomotic time (sum of the graft port creation, the target port
creation time, and the coupling time) is 199 ± 191 seconds [7]. This mean MVP anastomotic time is
significantly shorter then anastomotic time in hand-sewn anastomoses. This should decrease ischemia-
related complications during off pump surgery. A few clinical reports have been presented [7, 8]
confirming acceptable results at 6-months follow-up (figure 8.).
 Figure 8. Postoperative angiogram at 6 months after surgery
Magnetic resonance imaging (MRI) might be hazardous for patients with metallic implants
because of heating and movement of ferromagnetic objects by magnetic field interaction with MRI
systems. Two patients (with MVP implants) who underwent MRI, developed chest pain during
procedure which stopped immediately after cessation of the procedure [8]. Obviously, metallic
implants (MVP clips) inside the coronary arteries are sensitive to MRI procedures. It is strongly
recommended that MRI procedures shoul not be performed in patients with MVP-supported
anastomoses. The MVP distal anastomosis device is safe, applicable with all kinds of grafts, in any
coronary position, in end-to-side, as well as in side-to-side fashion.
In conclusion, any device should be validated on three essential characteristics: facility,
precision, and long-term effectiveness. Looking at the excellent long-term patency rate of the ITA
sutured in a conventional way to the LAD, it seems unacceptable to test new devices with unknown
long-term patency in this fashion (ITA-LAD). Therefore the ideal target vessels to test device shoul be
defined to be vessel other than LAD. The optimal postoperative anticoagulation treatment and the
assessment of patency rate at the different intervals during follow-up have to be harmonized.
Thus, a renesaince in cardiac surgery has begun, and robotic technology has provided benefits
to cardiac surgery. With improved optics and instrumentation, incisions are smaller. The placement of
wrist-like articulations at the end of the instruments moves the pivoting action to the plane of the
operative field. This improves dexterity in tight places and allows for ambidextrous suture placement.
Sutures can be placed more accurately because of tremor filtration and high-resolution video
magnification. Furthermore, „facilitated“ automatic (sutureless) anastomosis with magnetic devices is
now in clinical practice. Robotic systems may serve as educational tools. In the near future, surgical
vision and training systems may be able to model most surgical procedures through immersive
technology. Thus, a „flight simulator“ concept emerges where one may be able to simulate, practice
and perform the operation without a patient. Already, effective curricula for training teams in robotic
surgery exist [9, 10].

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