| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
Ann Thorac Surg 2002;74:746-751
© 2002 The Society of Thoracic Surgeons
a Division of Cardiothoracic Surgery, University of Wisconsin, Madison, Wisconsin, USA
Accepted for publication May 19, 2002.
* Address reprint requests to Dr Cochran, University of Wisconsin, CSC H4, 368, 600 Highland Ave, Madison, WI, USA 53792-3236
e-mail: cochran{at}surgery.wisc.edu
 |
Abstract |
|---|
 Top Abstract IntroductionPatients and methodsResultsCommentReferences |
|---|
Methods. In this retrospective review we evaluated the ability to place the ambulatory IABP, any complications, time on device, and success in bridging to transplant on the ambulatory IABP device. In addition, the cost as compared to current ventricular assist devices was determined.
Results. Between July 2000 and November 2001, 4 patients have been managed with ambulatory IABP in our combined University of Wisconsin and William S. Middleton Veterans Administration programs. All 4 patients had ischemia as their mode of heart failure, and each had a relative contraindication to standard ventricular assist device use. All 4 patients had ambulatory IABPs successfully placed through the left axillary artery without complication, and were able to ambulate early after ambulatory IABP placement, and increased their rehabilitation status before transplantation. Ambulatory IABP support ranged from 12 to 70 days. All 4 patients have been successfully transplanted and discharged from the hospital. Use of the ambulatory IABP support, even with multiple replacements, translated to 10- to 50-fold savings for each of the reported patients versus standard ventricular assist device use.
Conclusions. As a result of our initial experience, we believe that ambulatory IABP is an excellent mode of support in selected patients, and is cost-effective, as compared to conventional ventricular assist device therapy.
|
Introduction |
|---|
|
TopAbstractIntroductionPatients and methodsResultsCommentReferences |
|---|
Our center has an aggressive policy for bridge to transplantation and a complete compliment of VADs is used. Multiple devices are available; intraaortic balloons (IABP), Abiomed, Thoratec, and Heartmate (pneumatic and electrical), for all combinations of right, left, and biventricular support. The VAD use is tailored to the patient; however, some patients present with issues that make the use of these devices less appealing. Thus, we have introduced a modification or combination of two previously described techniques that allow for ambulatory IABP use into this algorithm. This has been done in an effort to minimize risk to patients, to attain early mobility and rehabilitation, and to contain cost.
Mayer [1] first described axillary/subclavian balloon insertion in a single patient in 1978. His technique required clavicular resection and was done on the right side. He did use a graft to aid in the insertion but did not advocate ambulation. McBride and colleagues [2] reported ambulatory IABP as a useful technique in the late 1980s. Their technique included isolation of the left axillary artery with direct cannulation of the artery through a pursestring suture. In addition, the catheter was tunneled subcutaneously along the chest wall and included external skin fixation for stability in ambulation. This technique also required return to the operating room for balloon removal. More recently, H’Doubler and associates [3] reported a technique using a vein cuff sewn to the left axillary artery for facilitation of IABP placement in patients awaiting cardiac transplantation and Buchanan and colleagues [4] reported a technique for ambulatory IABP use, placed through the iliac artery. Both of these techniques have limitations. The use of a vein cuff would not easily allow multiple changes. The iliac placement also limits exchanges and is a more morbid operation. As such, an alternative approach that allowed ambulation and multiple easy exchanges seemed to be warranted.
The purpose of this study is to report a modification of these techniques using a simplified ambulatory IABP technique that allows early ambulation and multiple balloon changes if necessary. The first 4 patients in whom this technique was used are reported. In addition, the cost effectiveness of this technology was evaluated. After this initial experience, we believe strongly that this technique should be considered more frequently in carefully selected patients.
|
Patients and methods |
|---|
|
TopAbstractIntroductionPatients and methodsResultsCommentReferences |
|---|
|
Indications for ambulatory IABP use
The ideal patient is a patient with end-stage cardiomyopathy of ischemic origin who has failed or is failing on inotropic support, either due to on-going ischemia, arrhythmias, or worsening heart failure. Arrhythmias of ischemic origin can be successfully treated with balloon therapy; however, nonischemic arrhythmias would be refractory and were not considered for treatment by this method. In addition, for this initial experience, all patients had some relative contraindication for VAD support. Such conditions include massive ascites, very small body size, and reoperation. All patients should have a trial of standard IABP support to prove the benefit before conversion to ambulatory IABP. The left subclavian/axillary arterial system should be free of disease. Patients who have a predictably long wait for transplant (ie, large patients with O blood type) may not be ideal as they will remain in hospital for the duration. However, if they have contraindications to VAD or if immediate rehabilitation is necessary, they too may be candidates for initial treatment with ambulatory IABP.
Patient population
Between July 2000 and November 2001, 39 patients received heart transplants (35 orthotopic heart, 3 heart/kidney, and 1 heart/lung) in our combined University of Wisconsin and William S. Middleton Veterans Administration programs. Seven of those patients received VAD therapy before transplant. (One additional patient who underwent VAD therapy was not transplanted.) During this time, there were only 4 patients who met the inclusion criteria as stated previously, and all 4 patients were managed with ambulatory IABP. All 4 patients had ischemia as their mode of heart failure. Review of patient data were approved by the University of Wisconsin Human Subjects Committee.
Patient 1 was a 53-year-old man cared for in the Veteran’s Administration healthcare system, height 5 feet 10 inches (176 cm), weight 166 lbs (75.5 kg), and body surface area of 1.95 m2. He presented with end-stage ischemic heart disease refractory to medical therapy and massive ascites with very poor conditioning. Ambulatory IABP treatment was chosen for this patient due to the desire of avoiding problems with his ascites and to allow for improved rehabilitation with minimal surgical setback. After proving the benefits of IABP in this patient with a femorally placed IABP, he was taken to the operating room for conversion to ambulatory IABP.
Patient 2 was a 54-year-old man, height 6 feet 0 inches (180 cm), weight 220 lbs (100 kg), and body surface area of 2.2 m2. He had previously undergone a successful heart transplant 14 years earlier and had developed ischemic disease in his graft. He underwent multiple interventional procedures in the cathetherization lab but was approaching end-stage disease. He was evaluated for retransplant and approved. However, his ischemia worsened requiring hospitalization and inotropic support that frequently worsened his ischemia. A trial femoral IABP was placed with a good response, in both hemodynamics and arrhythmias. He was converted to ambulatory IABP.
Patient 3 was a diminutive, 44-year-old woman, height 5 feet 4 inches (160 cm), weight 115 lbs (52.3 kg), and body surface area of 1.5 m2. She also had undergone coronary artery bypass grafting 3 years earlier. She had on-going refractory ischemic symptoms in the hospital. She remained refractory to pharmacologic therapy. A trial IABP was placed and she improved, and she was the converted to ambulatory IABP support.
Patient 4 was also a diminutive, 52-year-old woman, height 5 feet 1 inch (152 cm), weight 132 lbs (60 kg), and body surface area 1.6 m2 who had ischemic cardiomyopathy. She had no previous operation but had significantly elevated pulmonary artery pressures. Our concern was that biventricular support might be necessary, therefore a trial IABP was done with some improvement. She was converted to ambulatory IABP 4 days later.
With regard to potential for arteriosclerosis, all patients had a trial femoral artery balloon first. If there were to be complications due to arteriosclerosis in the descending aorta, this would have likely been seen at that time, and the patient would not have proceeded to ambulatory IABP. Before ambulatory IABP placement, all patients were evaluated with physical examination and were documented to have equal blood pressures in both upper extremities. The left side is chosen versus the right, as one of the primary failure modes for all IABP patients is angulation or kinking in the driveline. Utilization of the left axillary artery allows more reliable direct access to the aorta, with less potential for bending or kinking of the driveline, as compared to using the right axillary artery. All ambulatory IABP patients are anticoagulated within 48 hours of balloon placement per our institutional protocol, and all patients were treated with perioperative antibiotics. Due to pulmonary artery hypertension or need for right ventricular support, inotropic and afterload reducing therapy was continued in all patients.
Cost analysis
The cost was evaluated for the trial IABP placement, the initial ambulatory IABP placement, and any subsequent balloon catheter replacements for each of the 4 patients. This was compared to the cost of four types of VADs (Heartmate, Heartmate VE, Abiomed, and Thoratec), including device cost and the daily console rental fee, if applicable. This calculation was done assuming the patient would have been on the VAD for the same number of days as the ambulatory IABP, while awaiting transplant. For simplicity, device costs only were considered, and the cost of the operating room was excluded. This is due to the variable nature for VAD implant, that is, some implant procedures are straightforward and relatively fast (4 to 5 hours operating room time), whereas others may take several more hours and require massive transfusions and have a relatively high rate of return to the operating room for bleeding/evacuation of clot. Conversely, the ambulatory IABP procedures take only 60 to 90 minutes, and thus the operating room cost is much reduced. Thus, the exclusion of operating room costs gives a conservative analysis of savings due to ambulatory IABP placement.
Routinely, the VAD of choice is the Heartmate VE, which allows for discharge. None of these candidates were considered good candidates for the VE. As such, the potential reduction in cost of hospitalization due to discharge was not an option for any of these patients. Realizing this, the hospital daily charge is the same with either therapy, and is not calculated.
|
Results |
|---|
|
TopAbstractIntroductionPatients and methodsResultsCommentReferences |
|---|
Patient 2 was supported for 70 days, and required four balloon exchanges for leak in external housing, rupture, malfunction, and catheter fracture. Otherwise, he had no complications and was transplanted on postoperative day 70 with ambulatory IABP removal in the operating room. Because this patient had a prior transplant, his panel reactive antibody was checked, and on multiple preoperative checks the patient’s panel reactive antibody was zero, and thus was not a contributor to any problems. It is uncertain why there were more problems with this balloon therapy, other than the fact that this was the largest patient, and had the smallest conduit (4 mm) used.
Patient 3 had balloon support for 12 days, had no complications, and had no balloon exchanges. She was transplanted on postoperative day 12 with ambulatory IABP removal in the operating room.
Patient 4 was supported for a total of 15 days. In this patient, pulmonary artery pressures initially improved but then started to increase and her cardiac indices remained marginal. She had one episode of catheter fracture requiring ambulatory IABP exchange. This was likely due to her short stature, resulting in a relatively greater effective curvature in her ambulatory IABP catheter. She was fortunate to get an appropriate donor (ie, slightly larger), with some right ventricular conditioning, within days of a scheduled conversion to VAD support. She underwent orthotopic cardiac transplant on postoperative day 15. Her ambulatory IABP was left in for 4 days after transplantation because right-to-left filling was tenuous early on, even with nitric oxide and vasodilator therapy directly in the pulmonary artery through a Swan-Ganz catheter. Once right-sided conditioning improved by echocardiography, the ambulatory IABP was removed at the bedside without complications.
All patients were able to ambulate and increase their rehabilitation status before transplantation with the placement of the ambulatory IABP. Improvement in symptoms and hemodynamic profile was seen in all patients (Table 1). All 4 patients have been successfully transplanted, and have been discharged from the hospital.
|
|
Even if one plays the "devil’s advocate" and adds in multiple returns to the operating room for balloon exchange in some patients, the cost savings is still evident. This is because the exchange is a percutaneous procedure and takes less than 30 minutes. Thus, the total operating room cost for all five ambulatory IABP replacements would be less than the operating room time for one initial VAD procedure, and thus not including these costs is reasonable.
|
Comment |
|---|
|
TopAbstractIntroductionPatients and methodsResultsCommentReferences |
|---|
This initial small series of patients demonstrates that ambulatory IABP provided an excellent bridge to transplant in 3 of the 4 patients and showed a modest improvement in the fourth. There were no device-related infections or any bleeding or embolic complications in the hospital or long term, even with multiple balloon exchanges. All patients took perioperative antibiotics. None of the grafts required removal due to infection, false aneurysm, and other factors. There were no long-term complications in the axillary artery or left upper extremity noted in any patient. On the basis of the initial data, the ideal graft size is 6 mm, which matches best with the balloon for ease of insertion and removal without redundancy or excessive dead space.
Because foreign materials in immunosuppressed patients could be problematic, one must be prepared to remove the grafts if necessary. However, the use of the ribbed Gore-Tex grafts is necessary to allow for multiple balloon exchanges. Multiple exchanges with a pursestring would not be possible, and would be problematic with a vein graft due to possible damage and the necessity of shortening the vein graft at the point of securing the hemostatic ties around the balloon catheter at each exchange. As discussed previously, there were no infectious complications, thus the potential for problems were not realized.
There are several obvious advantages to ambulatory IABP over VAD use, including cost containment. From a surgical point of view, ambulatory IABP is technically much simpler. Ambulatory IABP avoids a sternotomy and the need for cardiopulmonary bypass. Furthermore, at the time of transplant, the removal of ambulatory IABP is quite simple and as in the case of our fourth patient, the ambulatory IABP can be used after transplantation. Conversely, a VAD implantation requires an obligatory sternotomy and additional cardiopulmonary bypass. In addition, the removal of a VAD is often difficult and has attendant complications. In addition, if assistance is needed after transplantation, VAD insertion is far more complex than continuation of ambulatory IABP. Finally, an additional advantage of IABP versus VAD therapy is that there is no report of increasing panel reactive antibody with IABP, whereas it is a common problem with VADs.
There are also advantages of ambulatory IABP over VAD as far as the support team is concerned. The nursing expertise for IABP management already exists in all cardiac units. As such, expanding its use to the telemetry unit is done easily and uneventfully. There is always plenty of expertise to assist in troubleshooting any IABP problems, whereas the VAD units are managed by a select group of individuals with special knowledge. This makes availability and expedient management more difficult for VAD than ambulatory IABP.
The VAD portable consoles are rapidly improving, but they are nowhere close to the ease of portability now found in the Datascope System 98XT portable console for ambulatory IABP use. Patients can easily push their own ambulatory IABP console around the telemetry unit with minimal initial conditioning, and often within days of operation. Our typical VAD patient is not ambulatory on telemetry for at least a week after operation. The minimal surgical impact of the ambulatory IABP versus VAD is obvious, based on its simplicity. The insertion of any of the VADs is a "major" operation with attendant cardiopulmonary bypass in the majority of patients and a huge metabolic and nutritional insult to these critically ill patients. Frequently, after VAD implantation, patients have to be taken off the transplant waiting list until they are stabilized or adequately recovered to undergo transplant. The ambulatory IABP patients can be extubated early, ambulated within hours to days of operation, and could be transplanted the same day of insertion if circumstances dictated without fear of added risks. With regard to the potential negative aspects of the technique, there is a small risk of thromboembolism and a small risk of vascular compromise in an atherosclerotic subclavian artery. The contraindications are in patients who do not have ischemic disease or those who have not responded favorably to IABP in the trial period. At present an additional negative aspect of ambulatory IABP therapy is that these patients cannot be discharged, as can the patients with Heartmate VE. However, in our institution this is not as large an issue, as historically there is a relatively short wait for status IA and IB patients, as compared to other institutions.
In conclusion, after our initial experience, we believe that ambulatory IABP is an excellent mode of support in selected patients. The ideal patient has an end-stage cardiomyopathy of ischemic origin, refractory to inotropic support, and with a relative contraindication to VAD support.
This modified technique of placement of a small expanded polytetrafluoroethylene vascular graft attached to the axillary artery and then tunneled subcutaneously to a remote access site on the skin facilitates rapid catheter exchange in the event of failure. This technical modification is easy to accomplish for any surgical team and makes replacement and removal quite easy.
The advantage versus the H’Doubler axillary vein graft technique is that the Gore-Tex graft allows for multiple exchanges of the balloon without having to shorten the graft, as would be necessary with a vein graft. In addition, in comparison to the Buchanan iliac artery technique for ambulatory IABP, the axillary approach is much simpler and allows for multiple exchanges of the balloon.
There are multiple clear advantages to the use of ambulatory IABP. The ambulatory IABP is a simpler, faster, and safer operation than VAD insertion. The ambulatory IABP uses familiar technology for nursing personnel. The exchange in the rare device failure is easy and has minimal impact to the patient. With the ambulatory IABP, early ambulation and rehabilitation is easily accomplished. There is a clear and huge cost containment benefit for ambulatory IABP versus VAD. For these reasons, we are continuing to develop this technique and are using it more aggressively in a wider patient population.
|
References |
|---|
|
TopAbstractIntroductionPatients and methodsResultsCommentReferences |
|---|
This article has been cited by other articles:
|
|
 |
|
  S. Mitnovetski, A. A. Almeida, A. Barr, W. S. Peters, F. P. Milsom, B. Ho, and J. A. Smith Extra-aortic implantable counterpulsation pump in chronic heart failure. Ann. Thorac. Surg., June 1, 2008; 85(6): 2122 - 2125. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
T. Sassard, A. Scalabre, E. Bonnefoy, I. Sanchez, F. Farhat, and O. Jegaden The Right Axillary Artery Approach for the Impella Recover LP 5.0 Microaxial Pump Ann. Thorac. Surg., April 1, 2008; 85(4): 1468 - 1470. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 L. U. Nwakanma, A. S. Shah, J. V. Conte, and W. A. Baumgartner Heart Transplantation Card. Surg. Adult, January 1, 2008; 3(2008): 1539 - 1578. [Full Text]
|
|
|
|
 |
|
 I. Norkiene, D. Ringaitiene, K. Rucinskas, R. Samalavicius, A. Baublys, S. Miniauskas, and V. Sirvydis Intra-aortic balloon counterpulsation in decompensated cardiomyopathy patients: bridge to transplantation or assist device Interactive CardioVascular and Thoracic Surgery, February 1, 2007; 6(1): 66 - 70. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. E. Legget, W. S. Peters, F. P. Milsom, J. S. Clark, T. M. West, R. L. French, and A. F. Merry Extra-Aortic Balloon Counterpulsation: An Intraoperative Feasibility Study Circulation, August 30, 2005; 112(9_suppl): I-26 - I-31. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. J. Magner and D. Royston Heart failure Br. J. Anaesth., July 1, 2004; 93(1): 74 - 85. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 B. Trotman-Dickenson Radiology in the Intensive Care Unit (Part I) J Intensive Care Med, July 1, 2003; 18(4): 198 - 210. [Abstract] [PDF]
|
|
|
|
 |
|
 B. A. J. M. de Mol Mechanical Support in Acute Perioperative Heart Failure: Are Assist Devices Smart Enough to Heal the Heart? Seminars in Cardiothoracic and Vascular Anesthesia, March 1, 2003; 7(1): 105 - 109. [PDF]
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
| ANN THORAC SURG | ASIAN CARDIOVASC THORAC ANN | EUR J CARDIOTHORAC SURG |
| J THORAC CARDIOVASC SURG | ICVTS | ALL CTSNet JOURNALS |
