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Ann Thorac Surg 2001;72:S1004-S1008
© 2001 The Society of Thoracic Surgeons

Supplement: Cardiothoracic techniques and technologies

Ventriculocoronary artery bypass results using a mesh-tipped device in a porcine model

Robert W. Emery, MDa, Frazier Eales, MDa, Clifford H. Van Meter, Jr, MDa, Mark B. Knudson, PhDb, Eric E. Solien, BSb, Katherine S. Tweden, PhDb

a Cardiac Surgical Associates, Minneapolis, Minnesota, USA
b HeartStent Corporation, Minneapolis, Minnesota, USA

Address reprint requests to Dr Emery, Cardiac Surgical Associates, 920 East 28th St, Ste 420, Minneapolis, MN 55407
e-mail: dremery{at}csa-heart.com

Presented at the Seventh Annual Cardiothoracic Techniques and Technologies Meeting 2001, New Orleans, LA, Jan 24–27, 2001.


   Abstract
Top
 Footnotes
 Abstract
Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
Background. In this report we describe the in vivo evaluation of a device and ventriculocoronary artery bypass procedure that creates a permanent transmyocardial channel between the left ventricle and a coronary artery.

Methods. The transmyocardial device, an L-shaped titanium tube with a meshed distal tip and an exterior polyester cuff, was implanted from the base of the left ventricle to the proximal left anterior descending coronary artery in 11 healthy juvenile domestic pigs using a beating-heart approach. Flow rates were measured at implant. Patency was assessed at explant for surviving animals at 2 (n = 3) and 4 weeks (n = 4).

Results. Flow through the transmyocardial device after implantation was 74% of base line. Forward flow occurred during systole. Luminal patency was 100% at 2 weeks and 75% at 4 weeks. Histologic analysis showed little to no intimal proliferation at the coronary interface.

Conclusions. This short-duration study shows promise for perfusing ischemic myocardium with systolic flow. The transmyocardial titanium conduit and treated coronary artery patency was good at 2 and 4 weeks and warrants further studies.


   Introduction
Top
 Footnotes
 Abstract
 Introduction
Material and methods
 Results
 Comment
 Acknowledgments
 References
 
Traditional myocardial revascularization involves dilation of obstructive lesions in native coronary arteries or redirection of vascular supply from a supravalvular source. Interest has been reestablished in the possibility of treating myocardial ischemia using a ventriculocoronary artery bypass (VCAB) technique [1]. As its name suggests, this technique shunts oxygenated blood from the left ventricle directly to a coronary artery. Because flow is pressure-driven, blood is delivered after a VCAB procedure to the target myocardium during systole rather than during diastole. Munro and Allen [2] suggested that a shunt directly from the left ventricle to a coronary artery is unlikely to succeed based on their observations of poor postimplant contractility and average coronary flows of 30% of base line in their acute animal study. However, Tweden and colleagues [1] demonstrated 76% of base line left anterior descending (LAD) coronary artery flow and 91% patency at 2 weeks in a juvenile porcine model undergoing a VCAB procedure using a novel implanted intracoronary L-shaped device. The study by Tweden and colleagues suggested the promise of reversing myocardial ischemia using a VCAB procedure and possible adaptation of the coronary vascular tree compliance as seen in cases of chronic aortic insufficiency.

The notion of treating ischemic myocardium by redirecting oxygenated blood from the left ventricle was originally proposed by Vineberg [3]. The conundrum at the time was how muscle adjacent to a large source of oxygenated blood could be ischemic. Vineberg’s approach involved implanting an internal mammary artery pedicle into the ventricular myocardium. Sen and coworkers [4] proposed the precursor to the current laser transmyocardial revascularization (TMR) techniques as a method to treat ischemic myocardium with blood directly from the left ventricle using an acupuncture technique to make transmyocardial holes in ischemic areas of the heart. Both the Vineberg and Sen techniques were gradually replaced by the current coronary artery bypass graft procedure. However, TMR recently reemerged, with transmyocardial channels formed using lasers [5]. Current laser TMR findings show that, despite acute occlusion of newly formed channels, quality of life for patients undergoing this procedure improves as measured by the New York Heart Association (NYHA) classification of angina [5] and, when coupled with coronary bypass, operative mortality is reported to be reduced significantly [6].

The transmyocardial device and VCAB procedure holds the promise of a less invasive approach with less patient trauma than conventional coronary artery bypass grafting. Specifically, we evaluated a small transmyocardial device that potentially lends itself to minimally invasive surgical techniques. This device can be implanted rapidly under beating heart conditions. The device maintains a high flow rate by connecting the left ventricular chamber directly with the lumen of an overlying coronary artery, and maintains that channel with a meshed, biocompatible conduit. Longer duration studies of the previously reported solid L-shaped device [1] suggested that a meshed coronary tip and enhanced epicardial stabilization would provide for long-term tissue integration and patency.

In the present report we describe the early-duration preclinical results of a transmyocardial coronary device for the revascularization of ischemic cardiac tissue.


   Material and methods
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
Results
 Comment
 Acknowledgments
 References
 
Device design
The prototype transmyocardial device design consisted of an L-shaped hollow tube with a gradual 90-degree bend. The dimensions of the device were 2.5 mm outer diameter, 25-mm long myocardial arm, and 7-mm long coronary arm with the last 4 mm having a laser-cut diamond pattern that resulted in an open area of approximately 85% (Fig 1). Unalloyed, grade 2 titanium (ASTM B-338 to 95, Tico Titanium, Inc, Farmington Hills, MI) was chosen as the substrate for the tube based on its long history of use in the cardiovascular environment, specifically in heart valve and artificial heart applications. A portion of the outer surface of the device was wrapped in polyethylene terephthalate (polyester velour, style 6108, C.R. Bard, Inc, Billerica, MA) fabric to encourage integration of the device within the myocardium. A stabilization component was attached to the bend of the device after implantation to prevent rotation at the coronary arm. This component was constructed of the same titanium as the direct revascularization device (DRD) and incorporated polyester to aid tissue integration on the epicardium. The device and stabilization component were steam-sterilized using standard techniques before use. Tools used in the implantation, referred to below, were either steam- or ethylene oxide-sterilized using standard techniques.



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  		Fig 1. Rendering of the transmyocardial device. A = the stabilizer; B = the meshed tip of the coronary arm; C = the myocardial arm of the device.

 
Surgical technique
All animals were treated according to the "Guide for the Care and Use of Laboratory Animals" (National Institutes of Health publication 85-23, revised 1985). The device was implanted in 11 normal, healthy domestic Yorkshire-cross pigs less than 1 year of age, weighing 65 to 75 kg as described previously [1]. Briefly, the pigs were treated with aspirin (325 mg q.d., p.o.) and clopidogrel (75 mg q.d., p.o., Plavix, registered trademark of Sanofi~Synthelabo Pharmaceuticals Inc, licensed to Bristol-Myers Squibb, New York, NY) beginning 3 days before the procedure and continuing until sacrifice. After intubation, anesthesia was maintained with 1% to 2% isoflurane. Lidocaine (2 mg/kg) was used to minimize arterial spasms. Cardiopulmonary bypass was not used (beating heart approach). A left thoracotomy and pericardial cradle were performed to expose the left anterior wall of the heart. Systemic arterial pressure was monitored. The animals were systemically heparinized as in a human "off-pump" model (125 U/kg heparin). A 1-cm segment of both mid- and distal-LAD was mobilized circumferentially.

A 2.0- to 3.0-mm ultrasonic flowprobe (Transonics model 2.5 or 3.0SB, Ithaca, NY) was placed around the distal LAD segment to monitor blood flow rate. The flowprobes were electronically calibrated to 0 before each experiment. Base line electrocardiogram, systemic arterial pressure, and LAD blood flow rate were recorded for approximately 4 minutes (Gould 6600 Smart Case, Gould Instrument Systems, Inc, Valley View, OH). The heart was then preconditioned by occluding the LAD for 15 seconds.

The transmyocardial device was primed with heparinized saline (2 U/mL heparin) before implantation. The device was first seated into the left ventricle using the method and tools (a cone-shaped introducing sheath with dilator) previously described [1]. The proximal LAD was ligated to simulate a totally occluded artery. A longitudinal incision was made in the LAD distal to the ligation. The device was then introduced into the coronary artery using a custom-designed polymer introducer. The device was secured in the LAD and anchored to the myocardium using 3-0 polyester suture material. The average implant ischemic time was 109 ± 22 seconds (n = 11).

The stabilization component was then attached to the bend of the device and secured to both device and epicardium with polyester suture placed around the stabilizer and DRD and through fabric-covered members of the stabilizer.

The flowprobe was replaced around the LAD distal to the transmyocardial device. electrocardiogram, arterial pressure, and LAD blood flow rate were measured, as described above, within 10 minutes after the device was implanted. A paired t-test was used to compare base line flow rates with device flow rates. Finally, the pericardial sac was loosely approximated, the thoracotomy closed, and the animals recovered. They were then sacrificed at 2 or 4 weeks.

Tissue preparation
Pigs were sacrificed using Buthanasia (Schering-Plough, Kenilworth, NJ). Fifteen minutes before sacrifice the animals were given 250 U/kg heparin. The heart was quickly exposed by means of a right thoracotomy, and then excised. The LAD was perfusion-rinsed at 100 to 120 mm Hg with lactated Ringer’s solution until the artery ran clear. McDowell-Trumps fixative was introduced next and infused at 100 mm Hg for 15 minutes. The heart was then placed in 1 L of fresh fixative and fixed for at least 24 hours before handling.

After fixation, the device/artery interface was exposed by carefully cutting longitudinally starting 2 cm distal to the device and ending 5 mm proximal to the myocardial insertion site of the device. The interface was photographed macroscopically (Nikon SMZ-U, Nikon, Inc, Melville, NY). The heart was assessed grossly for changes to the artery, epicardium, myocardium, and endocardium. Serial sections were taken from the LAD proximal to the device and approximately 1, 3, and 5 cm distal to the device to assess arterial changes and to look for embolization. The device was removed by cutting the polyester cuff longitudinally along the myocardial arm of the device. The remaining block of tissue was divided into a coronary artery block and a myocardial cuff block along the device tract. The device/artery interface block was cut longitudinally to assess arterial reaction and the myocardial block was cut transversely to assess integration of the fabric. To assess perfusion histologically, the myocardium was sectioned at two locations distal to the device and at the septum. All blocks, except the cuff block, were paraffin-embedded, sectioned, and stained with hematoxylin and eosin (H&E). The cuff block was plastic-embedded and stained with H&E only. The titanium portion of the device was removed from the heart, sectioned in half with a low-speed diamond saw (Isomet 1000, Buehler, Inc, Lake Bluff, IL), dehydrated through a series of ethanols, critical point-dried with CO2 (Autosamdri-814, Tousimis, Inc, Rockville, MD), coated with 200 Å of carbon (DV-502A Vacuum Evaporator, Denton Vacuum, Moorestown, NJ), and analyzed by scanning electron microscopy (Hitachi S-450, Hitachi, Inc, Mountain View, CA) for biological deposits.


   Results
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
Comment
 Acknowledgments
 References
 
The flow pattern seen with this transmyocardial device is one of forward flow during systole and retrograde flow during diastole as shown in a sample result in Figure 2. No areas of stasis occur at any portion of the cardiac cycle. Flow through the device immediately after implantation averaged 74% ± 28% of base line flow. Average peak forward flow measured 213 ± 105 mL/min and average peak retrograde flow measured -97 ± 40 mL/min through the device compared with 56 ± 22 mL/min average peak forward and -27 ± 14 mL/min average peak retrograde in the native coronary artery (p = 0.0002 for peak forward flow and p < 0.0001 for peak retrograde flow).



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  		Fig 2. An example of flow and systemic arterial pressure waveforms for (A) the base line left anterior descending coronary artery (LAD) and (B) the experimental device immediately after implantation. Instantaneous flow measures are plotted to define the flow curves for both native coronary flow and direct revascularization device-supplied flow. The greatest of the discrete forward and retrograde instantaneous values are considered the peak flow forward and retrograde, respectively. Forward flow is calculated as the running average of all the instantaneous flow velocities including both forward and retrograde, measured over an entire cardiac cycle. Note diastolic flow in (A) as compared with systolic flow in (B). (SAP = systemic arterial pressure.)

 
Four early deaths occurred in this study. Three animals died less than 24 hours after implantation because of acute thrombosis in the device. Postmortem analysis showed inadequate protrusion of the device into the left ventricle. Prior procedural experience has indicated that inadequate left ventricular protrusion will lead to sudden thrombotic failure of the device (K. Tweden, oral communication). Importantly, no arterial damage was seen in any of these early deaths. The fourth animal died 7 days after implantation from an apparent acute myocardial infarction with an intracardiac thrombus in an area proximal to the device that appeared to have occluded the inflow of the device. In addition, a general carditis was present in this animal that could have stimulated thrombus formation.

Seven pigs survived to scheduled sacrifice. Three animals were sacrificed at 2 weeks and four animals were sacrificed at 4 weeks. All three devices were patent in the 3 pigs sacrificed at 2 weeks. Three devices were patent and one device was occluded in the 4 pigs sacrificed at 4 weeks. The occluded device explanted at 4 weeks caused arterial damage at some time during implant from a defect in the metal on the coronary arm of the prototype device. This defect was identified by microscopic evaluation after explantation. The arterial damage resulted in tissue proliferation at the coronary arm and subsequent occlusion of the device.

Gross analysis of the device/artery interface of the patent devices showed minimal tissue covering the mesh portion of the coronary arm (Fig 3). Histologic analysis of this tissue showed no detectable intimal proliferation (Fig 4). The internal elastic membrane of the artery was intact in all patent devices. Scanning electron microscopic analysis of the coronary artery–device interface showed that the device was lined with nonthrombogenic endothelial-like cells. Scanning electron microscopic analysis of the device interior showed little deposition of thrombotic material up to 4 weeks. Tissue ingrowth into the cuff was characterized by fibroblast infiltration with a mild to moderate inflammatory cell response as reported previously [1]. Minimal changes were seen in the myocardium that occurred because of the initial ischemic event of implanting the transmyocardial device and blockage of septal perforator branches of the LAD. No evidence of progressive ischemia was observed in the patent devices.



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  		Fig 3. Gross photograph of device–artery interface 4 weeks after implantation. The left anterior descending coronary artery opened longitudinally. (da = distal artery.)

 


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  		Fig 4. Photomicrograph of reaction at device/artery interface shown in Figure 2 (device is removed). (Hematoxylin and eosin; x40 before 50% reduction. D = the space that was occupied by the device; da = distal artery.)

 

   Comment
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
Acknowledgments
 References
 
Munro and Allen’s conclusion [2] that myocardial revascularization directly from the left ventricle is likely to fail due to ischemia is not supported by our findings. Specifically, we obtained flows of 74% of base line that sustained the growth of a juvenile model for 4 weeks with minimal changes to the myocardium. We could not determine from Munro and Allen’s description of study methods why they did not achieve the currently reported results. However, we postulate that the design and placement of their conduit may account for their results. We observed maximum flows of 133% of base line in our experiments compared with a maximum of 48% in the Munro and Allen study. In addition, we observed peak forward and retrograde flow rates that were four times greater than native flow rates (p = 0.0002). These flow rates may favorably affect long-term patency. By 4 weeks postimplant, the coronary arm was fully integrated with a lining of blood-compatible tissue. The current study clearly illustrates that adequate protrusion into the left ventricle is critical for maintaining patency of the device (Fig 5). We postulate that the highly thrombogenic tissue factors present in the myocardial tissue results in occlusion of the transmyocardial device when the inflow edge is within or close to the endocardial border of recently damaged tissue (due to introduction of the device into the left ventricle) or that the contraction of the left ventricular myocardium directly occludes the proximal lumen of the DRD. The early occlusion of channels made through the myocardium using TMR techniques may support our findings of the need for adequate protrusion as highly thrombogenic tissue factors are released while creating laser channels [5, 6].



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  		Fig 5. Gross photograph of device/endocardial interface 4 weeks after implantation.

 
Our data indicated that a juvenile pig heart can be sustained with systolic LAD flow for as long as 4 weeks. Although the idea of perfusing the coronary arteries during systole is nonintuitive because native coronaries are perfused during diastole, a group of patients from the 1950s and 1960s reportedly had myocardium supported by systolic flow [7–9].

The mid-1950s brought enormous advances in open-heart surgery, including the first prosthetic aortic heart valve for the treatment of severe aortic regurgitation, the Hufnagel caged-ball prosthetic valve [7]. To circumvent the need for cardiopulmonary bypass, the valve was designed for placement in the descending aorta immediately distal to the left subclavian artery where aortic occlusion is well tolerated. The valve could be implanted within 3 to 6 minutes [7]. Because of the implant location, the left ventricle essentially was extended to the proximal aspect of the Hufnagel valve. Specifically, the coronary ostia and the aortic arch were extensions of the left ventricle and as such were subjected to the pressure cycles of the left ventricle. This anatomic reconfiguration results in blood being delivered to the coronary ostia during systole. Because the native aortic valve is incompetent, it must fall to a much lower than normal pressure during diastole. Coronary perfusion pressure is significantly reduced during diastole in this situation, unlike diastole in the native coronary configuration.

A significant number of patients led quality lives for more than 10 years and a few for close to two decades after the Hufnagel valve procedure [8, 9]. For example, Liddicoat and coworkers [8] reported on the assessment of a patient 18 years after having a Hufnagel valve implanted in the descending aorta to correct aortic regurgitation. Ventriculography demonstrated good left ventricular function and selective arteriography demonstrated normal coronary arteries.

More recently, Cale and colleagues [10] described a modified Hufnagel procedure as an alternative approach to the management of high-risk patients with noninfected aortic valve prostheses that are regurgitant or have paraprosthetic leaks. The risk factors included high NYHA functional class, cardiac failure, coronary artery disease, number of reoperations and advancing age. The patients (4 total) were followed from 4 months to 6 years and all exhibited two NYHA functional class improvements. Although this group is too small to be statistically significant, the coronary arteries of all 4 patients were perfused during systole after completion of the modified Hufnagel procedure. The longest surviving patient was assessed at NYHA class I at 6 years, suggesting that a heart perfused during systole can support good quality of life.

The studies described above demonstrate good quality of life, long-term survival, and good ventricular function in patients whose hearts were supported for almost 20 years by systolic coronary perfusion. Most prosthetic failures were those associated with failure of the synthetic materials, such as infection and thrombosis, and the interface between the device and the aorta.

The direct revascularization device and procedure evaluated has potential advantages to conventional CABG. The device is implanted under beating heart conditions, avoiding the complications of cardiopulmonary bypass. This procedure may serve as a primary procedure or adjunct to complete revascularization. Trained surgeons find that the time of ischemia during implantation is less than 2 minutes. The device is small, potentially requiring minimal access incisions. Painful leg incisions required for saphenous vein graft harvest are avoided.

In conclusion, the novel transmyocardial device (and VCAB procedure) we evaluated has the following characteristics: It (1) creates a permanent channel between the left ventricle and coronary artery, (2) perfuses the heart with systolic flow, (3) has a net forward flow at implant of 74% of base line coronary flow, (4) is implanted in a beating heart, (5) must protrude adequately into the left ventricle, (6) has good patency (75%) 4 weeks after implantation, and (7) stimulates the formation of a nonthrombogenic tissue lining on the matrixed coronary arm. Results of this study suggest that this device and surgical technique offer a promising option for coronary bypass and warrant studies of longer duration.


   Acknowledgments
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
References
 
Sincere thanks are extended to the individuals who assisted in the operations, data collection, and analysis, including Dale Groth, Kris Hagen, and Sue Perron. Robert H. Busch, DVM, PhD, was the study pathologist.


   Footnotes
Top
 Footnotes
Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
Drs Emery, Eales, and Van Meter serve on the HeartStent Scientific Advisory Board. Drs Knudson, Solien, and Tweden are employees of HeartStent Corporation.


   References
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 

  1. Tweden K.S., Eales F., Cameron J.D., Griffin J.C., Solien E.E., Knudson M.B. Ventriculocoronary artery bypass (VCAB), a novel approach to myocardial revascularization. Heart Surg Forum 2000;3:47-55.[Medline]
  2. Munro I., Allen P. The possibility of myocardial revascularization by creation of a left ventriculocoronary artery fistula. J Thorac Cardiovasc Surg 1969;58:25-32.[Medline]
  3. Vineberg A. Development of an anastomosis between the coronary vessels and a transplanted internal mammary artery. Can Med Assoc J 1946;55:117-119.
  4. Sen P.K., Udwadia T.E., Kinare S.G., Parulkar G.B. Transmyocardial acupuncture: a new approach to myocardial revascularization. J Thorac Cardiovasc Surg 1965;50:181-189.
  5. Horvath K.A., Cohn L.H., Cooley D.A., et al. Transmyocardial laser revascularization: results of a multicenter trial with transmyocardial laser revascularization used as sole therapy for end-stage coronary artery disease. J Thorac Cardiovasc Surg 1997;113:645-654.[Abstract/Free Full Text]
  6. Allen K.B., Dowling R.D., DelRossi A.J., et al. Transmyocardial laser revascularization combined with coronary artery bypass grafting: a multicenter, blinded, prospective, randomized controlled trial. J Thorac Cardiovasc Surg 2000;119:540-549.[Abstract/Free Full Text]
  7. Hufnagel C.A., Harvey W.P. The surgical correction of aortic regurgitation. Bull Georgetown Univ Med Center 1953;6:60-61.
  8. Liddicoat J.E., Bekassy S.M., De Bakey M.E. Double prosthetic aortic valve. Case report. J Thorac Cardiovasc Surg 1975;69:763-766.[Abstract]
  9. Fishbein M.C., Roberts W.C. Late postoperative anatomic observations after insertion of Hufnagel caged-ball protheses in descending thoracic aorta. Chest 1975;68:6-11.[Abstract/Free Full Text]
  10. Cale A.R.J., Sang C.T.M., Campanella C., Cameron E.W.J. Hufnagel revisited: a descending thoracic aortic valve to treat prosthetic valve insufficiency. Ann Thorac Surg 1993;55:1218-1221.[Abstract]



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