Reuse of coronary angioplasty equipment: Technical and clinical issues

EDITORIAL

Reuse of coronary angioplasty equipment: Technical and clinical issues

Koon-Hou Mak, MBBS, Mark J. Eisenberg, MD, MPH, David S. Eccleston, MBBS,

J. Fredrick Cornhill, DPhil, and Eric J. Topol, MD Cleveland, Ohio

Percutaneous transluminal coronary angioplasty (PTCA) is a common procedure used to relieve symptoms of angina. In 1994 an estimated 420,000 PTCA-related procedures were performed in the United States. 1 At an average charge of $16,000 per procedure, 2 the total hospitalization charges for un- complicated procedures is an estimated $6.7 billion. Because the equipment accounts for approximately 15%to 20% of the total cost of the procedure? reuse has been suggested as a way to decrease health care costs. Thus an estimated $1.3 billion might be saved in the United States each year ff PTCA equipment was reused.

Many centers in Europe, South America, Asia, and Canada reuse PTCA equipment. For example, in 1991 the Canadian Coordinating Office for Health Technology Assessment identified 46 hospitals in Canada providing cardiac catheterization services. Of the 44 hospitals that responded to the survey, 17 (39%) reused PTCA catheters. 4 With increasing concern about cost containment, the possibility of reusing PTCA equipment in the United States should be considered. We aim to review the technical and clinical issues pertinent to catheter reuse---including risk of device breakage, particulate body embolization, catheter performance, infection, endotoxic reactions, and toxicity--and to analyze the potential cost benefits of PTCA equipment reuse.

Risk of equipment breakage. The possibility of an increased risk of breakage is one of the major concerns of reusing PTCA catheters. Loose fragments may embolize or damage the vessel wall, re- sulting in clinical complications and a prolonged

From the Departments of Cardiology and Biomedical Engineering, The Cleveland Clinic Foundation.

Received for publication June 27, 1995; accepted Aug. 2, 1995.

Reprint requests: Eric J. Topol, MD, Department of Cardiology/Desk F25, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195.

AM HEART J 1996;131:624-30.

Copyright © 1996 by Mosby-Year Book, Inc. 0002-8703/96/$5.00 + 0 4/1/69489

procedure. The tensile strength of equipment may deteriorate with each additional use. Furthermore, resterilization of PTCA equipment with agents such as ethylene oxide may change the physical characteristics of the polymer and thereby affect the physical integrity of guiding and balloon catheters. 5 These factors may increase the likelihood of equipment breakage.

Diagnostic and guiding catheters. Breakage has been reported with both new and reused diagnostic catheters. 6-9 The incidence of catheter breakage during diagnostic coronary angiography has been reported to be I in 12,000 procedures. G, 7 Although the fragments embolized, they were removed percuta- neously without significant clinical complications. However, no studies have compared breakage rates of new and reused catheters. Nonetheless, in vitro reports suggest that the reuse of diagnostic catheters (up to 10 times) is not associated with increased risk of breakage compared with new catheters. 1° Similar studies have not been performed on guiding catheters.

The mechanical properties of catheters may deteriorate with age. G, 9 Schneider et al.6 found that aging appears to weaken the bond between the tip of polyurethane catheters and the stainless steel-rein- forced body. Tensile strength is reported to weaken within 3 years of manufacture. For this reason, the date of manufacture should be stated on all catheter packaging so operators know the age of the catheters.

Balloon catheters. Balloons sometimes rupture during PTCA, which may lead to clinical complications. In an early study, Simpfendorfer et al. n reported that in a series of 1500 PTCAs with new balloon catheters, 55 (4%) ruptured. These balloons ruptured at pressures ranging from 8 to 16 atm, which was higher than their rated burst pressures. In the patients in whom balloons ruptured, 18 (33%) had small intimal tears, and 3 required emergency coronary artery bypass graft surgery. There were no adverse outcomes in the remaining 52 patients after 18.7 months of follow:up. Similarly, in other re-

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ports, 12"16 balloons ruptured when inflated to more than the rated burst pressure. In fact, Gerlock et al., 12 in an in vitro model, found that pressures two to three times the recommended limits were required to rupture polyvinyl and polyethylene balloons. Therefore the risk of balloon rupture is diminished by avoiding inflations higher than the rated burst pressure. However, when balloon catheters are reused, reprocessing may weaken the plastic structure and lower the rated burs t pressure, thereby increasing the chance of rupture. There is little information addressing this issue in the medical literature. As such, until more data are available, reused balloon catheters should not be inflated above the rated burs t pressure.

A possible mechanism for vascular injuries after balloon rupture is the sudden release of a jet from a perforation.17, is In earlier studies, balloons were made of weaker material, such as polyolefin copoly- mer, and ruptured at lower pressures than current balloons do. 11, 16 The lower pressure during rupture may have resulted in less damage to the vessel wall and, therefore, a lower complication rate.

Polyethylene terephthalene is currently used to make noncompliant balloons that allow high-pressure inflation. When these balloons rupture, myocardial infarction and death have resulted. 17 In these patients, balloons perforated as a pinhole, which may have resulted in a high-pressure je t that dis- sected the intima and closed the vessel. Subsequent at tempts to recanalize the vessels failed. Currently, several methods are used to treat abrupt vessel closure, 19-21 including perfusion balloons and intracoronary stents, that reduce the risk of emergency coronary artery bypass graft surgery, myocardial infec t ion , and death. Nonetheless, these t reatments increase costs. Other at tempts to reduce the adverse complications associated with pinhole rupture in- clude designing balloons to leak at the proximal bonding site before rupture 22 or to rupture longitu- dinal]y. These designs decrease the abruptness of rupture and spread the force of the jet over a larger area. The efficacy of these strategies has not been clinically evaluated.

Guide wires and inflation devices. Guide wires have also broken during PTCA and have led to significant adverse sequelae, including emergency coronary bypass surgery. 2s However, it is unlikely that guide wires could be reused because they are fragile and need to be shaped for each target lesion. There have been no studies on this issue. Unlike catheters and guide wires, inflation devices do not come into direct contact with the patients' blood under usual circumstances. Therefore these devices could be re-

used after proper cleaning and sterilization if the performance of the manometer is not affected.

New devices. Recently, the use of new percutaneous coronary revascularization devices has become increasingly common. Each directional atherectomy device or rotational atherectomy burr costs more than $1,000. However, the average cost of a balloon catheter ranges from $300 to $600. In addition, more than one burr is commonly used during rotational atherectomy. Indeed, when Ellis et al3 evaluated the clinical, technical, and administrative determinants for in-hospital costs of percutaneous coronary revascularization in 1,258 procedures, high-speed rotational atherectomy increased costs by 33%, and directional atherectomy increased costs by 11%. The effect of rotational atherectomy on cost is higher because several burrs are used during each procedure. Therefore if these devices can be reused, the potential savings are even greater than in the case of balloon r e u s e .

Although few clinical studies have addressed the risk of equipment breakage, in vitro studies suggest that reused catheters do not break more often than new ones. The clinical performance and reliability of reused balloon catheters and new devices remain to be established.

Risk of particulate body emobilization. A second concern of reusing PTCA catheters is the risk of particulate body contamination. Particulate bodies consist of small pieces of plastic loosened by t rauma or blood components that are retained on the surface or in the lumen of a catheter. The long, narrow lumen of coronary catheters increases the chance of retaining particles. Particulate contamination during intravascular procedures can potentially lead to embolization, foreign body granuloma formation, 24 and platelet agglutination. 25

In 1976 Bourassa et al.26 examined by scanning electron microscopy six polyurethane and six polyethylene diagnostic angiographic catheters after a single use. The catheters were sectioned and fixed immediately after the procedure. Thrombi were found on the irreg~alar walls in all the polyurethane catheters and in 2 of the 6 polyethylene catheters. However, these catheters were not cleaned or sterilized after use.

Bentolila et al.zo determined the clinical signifi- cance of these particles if the catheters were reused (with some catheters tested being used up to 10 times) in a clinical setting. A strict protocol for cleaning and sterilization was established. To simu- late angiography, purified water was injected through both new and reused catheters, and water samples were then tested for particles. More parti-

March 1996 626 M a k et al. American Heart Journal

Table I. Procedural results and adverse events from PTCA performed with new (single-use center) and reused (reuse center) catheters

Single-use Reuse center center

(%) (%) P va~e

Number of pat ients 373 (100) 320 (100) Angiographic success (%) 88 88 NS Clinical sett ing

Stable angina 159 (43) 88 (27.5) NS Unstable angina 213 (57) 224 (70) <0.005 Myocardial infarction 1 (0.3) 8 (2.5) NS

Abrupt closure per lesion Inside cath lab 12 (2) 15 (3.7) NS Outside cath lab 3 (0.7) 12 (3.0) <0.01 TOTAL 15 (3.3) 27 (6.7) <0.025

Equipment (per lesion) Guiding catheters 1.2 1.3 <0.02 Balloon catheters 1.2 2,4 <0.00001

Per pat ient Contrast volume (ml) 165 201 <0.0001 Procedure t ime (rain) 68 81 <0.0001

Adverse events Late closure 3 (0.8) 12 (3.8) <0.01 Myocardial infarction 6 (1.6) 10 (3.1) NS CABG

Urgent 4 (1.1) 13 (4.1) <0.025 Nonurgent 3 (0.8) 5 (1.5) NS

Death 3 (0.8) 6 (1.9) NS

Adapted with permission from the American College of Cardiology (from Plante et al. J Am Coll Cardiol 1994;24:1475-81). CABG, Coronary artery bypass graft surgery; NS, not significant.

cles were found in the water samples of new, r a t h e r than reused, catheters and the number of particles was well within permissible levels. 27 Although scanning electron microscopy detected scratches, occa- sional surface ruptures, and debris on the lumen surface of the catheters, the authors concluded that these features were not clinically significant because the particles were firmly attached to the wall of the catheter and were unlikely to dislodge during injec- tions. 10

Catheter performance. Another major concern regarding the reuse of cardiac catheters is whether they function as well as new catheters. Preformed catheters may change their shape after multiple uses, and balloons may not wrap as well, thereby increasing their profile. There may be other alterations in the physical characteristics of the catheter, including changes in torque transmission and how it maneuvers, tracks, and pushes. All these factors can affect the performance of reused catheters~ However, no in vitro study has addressed these issues, and information is available from only one published study.

Plante et al. 2s prospectively evaluated the clinical performance of reused PTCA catheters in two cen-

ters in Canada (Table I). During a 10-month period, data were collected from 373 patients in a Toronto hospital who received new catheters and from 320 patients in a Quebec hospital who received reused catheters. Coronary angioplasty was performed ac- cording to standard practice. Angiographic success was the same for the two centers (88%). However, the center that utilized reused catheters required 2.4 balloons per lesion compared with 1.2 balloons per lesion for the single-use center. One of the reasons for more balloons per lesion in the reuse center was that the failure rate to cross the lesion with the first balloon was much higher: 12.3% compared with 3.6% in the single-use center. This difference may be accounted for by higher crossing profiles of the reused balloons. Newer balloon catheters, developed to wrap better after inflation, may be more suitable for reuse. Certain clinical and angiographic morphologic characteristics may also be used to identify lesions that are more appropriate for reused catheters to improve crossing rates. In addition, the operators in the center that reused balloon catheters started with un- dersized balloons and increased balloon size as needed. This practice may partly account for the higher number of balloons used.

Beyond the balloon use, the center that reused catheters used significantly more contrast (36 ml) and had 20% longer procedure times (13 minutes) per patient than did the single-use center (Table I). In addition, the operators subjectively felt t ha t the reused catheters required more push and manipulation than did a new balloon catheter. The need for increased force could have resulted in more t rauma to the vessel wall, especially in unstable and complex lesions. Indeed, in the reuse center, the rate for major complications was 10.6% compared with 4.2% in the single-use center. However, the difference in complication rates between the two centers could be partly accounted for by the higher number of patients with unstable angina in the reuse center (70% vs 57%).

Because the trial by Plante et al2s was not randomized, the results must be interpreted with caution, Some authors believe that the routine reuse of PTCA catheters in cardiovascular laboratories outside the United States for the past several years is adequate proof that the practice is as effective and safe as using new catheters. 29' 30 Nevertheless, it is still likely tha t the performance of reused catheters is reduced to a certain extent, although possibly less than that described by Plante et al.2s

Infection. The risk of infection is another major concern regarding equipment reuse. Viral and bacterial infections have been transmitted through

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intravascular devices, especially after use in patients with infections. 31

Viral infection Although the risk of viral infection with catheter reuse has not been examined in clinical studies, in Vitro experiments suggest that the risk is not increased. Hepatitis B and human immunode- ficiency virus (HIV) are of particular concern. By using very high concentrations of HIV samples, Res- nick e ta ] . 32 examined the stability of the Virus in clinical and laboratory environments. After 1 to 3 days of drying, the virus was not detected by tissue culture techniques. The rate of inactivation of the virus was even faster. Even though the hepatitis B virus is more resilient than HIV, the Center for Disease Control and Prevention 33 recommends that the current policy of universal protection and standard procedures for cleaning, disinfecting, and sterilizing equipment are adequate to prevent viral transmission.

Bacterial infection Studies in the 1960s ~4, 35 reported bacteremia rates of 4% to 18% in patients un- dergoing cardiac catheterization with new catheters. Sande et al. 36 later studied 106 patients who under- went cardiac catheterization. All patients had a right heart s tudy through the right median basilic vein, and 84% of the patients also had a left heart study through the right femoral artery. The authors found that none of the 214 blood cultures obtained from the arm opposite the catheter during the procedure was positive for bacteremia. In comparison, 8% of the cultures were positive for bacteremia when they were drawn from the "working" catheter. They concluded that manipulation during catheterization could have contaminated the hub end of the catheter or the insertion site, which resulted in the positive blood cultures. Thus with aseptic techniques, bacteremia is uncommon during diagnostic coronary angiography.

In vitro studies have been conducted by subjecting diagnostic catheters to high concentrations of patho- gens, 37 spores, as and heavily contaminated blood 39 after multiple reuses. By using a strict protocol for cleaning and sterilizing with ethylene oxide, the in- vestigators37, as found that the catheters were sterile unless the lumen had been obstructed. However, when a detergent (quaternary ammonium com- pound) was used for sterilization, Shawker et al. 4° found that blood cultures were positive in 23 of 100 angiographic procedures. Frank et al. 41 later reported that reusing catheters in patients after care- ful cleaning and sterilization with ethylene oxide was not associated with an increased risk of infection. Therefore with a proper protocol for cleaning and sterilizing catheters and ensuring that the

lumens are not obstructed, the risk of bacterial infection from reused catheters does not appear to increase.

Endotoxic reactions. Foreign particles and substances may be retained in catheters after use. Although the risk of embolization is low during reuse, the patient can react to the foreign particles or substances in the form of an endotoxic reaction, which consists of fever, chills, and hypotension.

In 1979 there were three outbreaks of endotoxic reactions in the United States after diagnostic cardiac catheterization with reused catheters. 42, 43 Ja- cobson et al.4¢ prospectively evaluated 341 patients who had cardiac catheterization with new and reused catheters. The overall incidence ofhypotension was 27%, fever was 3%, and chills was 3%. There was no difference in these complication rates between the patients with new and reused catheters. They also found that these reactions were not a result of bacterial infections. Pseudomonas, Acinetobacter, Es- cherichia, Enterobacter and other gram-negative organisms were cultured from the soap water used to wash the catheters and the distilled water used for flushing the catheters. 44, 45 Although sterilization with ethylene oxide destroyed these organisms, endotoxins were detected in the distilled water. These endotoxins probably caused the endotoxic reactions. Therefore Kundsin and Walter 45 developed a simple, reproducible, and rapid technique to measure endotoxin-like activity on the inner and outer surfaces of catheters. By measuring this activity', catheters could be labeled as pyrogen-free and the incidence of such reactions could be reduced. With a stringent protocol for cleaning, sterilizing, and quality control, Gensini 3° reduced the incidence of pyrogenic reactions to less than 1 in 1,000. Therefore the risk for pyrogenic reactions with reused catheters is not higher than that of new catheters.

Toxicity. There are several ways to sterilize PTCA equipment, including moist heat by steam autoclave, dry heat, liquid chemicals, and g a s Y Plastics may be denatured by heat. Prolonged contact time with liquid chemicals may also alter the quality of the plastics. Ethylene oxide, a gas, is therefore the most common agent used to sterilize PTCA catheters. However, when ethylene oxide combines with saline, it forms ethylene ch]orohydrin; water and ethylene oxide form ethylene glycol. Both substances are toxic to humans. 46 Furthermore, the porous material used to manufacture PTCA catheters can absorb these toxic substances. 47 Toxicity from ethylene chlorohy- drin can be averted by avoiding saline during reprocessing. In addition, after cleaning and sterilizing the catheters, adequate time is required for aeration

March 1996 628 Mak et al. American Heart Journal

800

700

600

500

400 r-

300

20O

100

0

-AV- $800 --B- $600

~ ~ 5 ~ $400

123 ~ 125 =" - ~ g 2

I I I I I Single Use 1 Reuses 2 Reuses 3 Reuses 4 Reuses 5 Reuses

Fig. 1. Calculated savings based on baseline cost of balloon catheters ($800, $600, or $400) and number of reuses. Cost of reprocessing for each reuse is $30. Cost per balloon use was calculated based on (Balloon cost + [(n - 1) × 30])/n, where n was current use of balloon. Reprinted with permission from the American College of Cardiology (Plante et al. J Am Coll Cardiol 1994;24:1475-81).

so that substances such as ethylene oxide and ethylene glycol can diffuse out of the catheter. 3s This aeration time prolongs the turnaround time for catheter reprocessing to between 12 and 14 hours.

Another problem associated with ethylene oxide as a sterilizing agent is the possible environmental hazard. The gas mixture used for sterilization consists of 88% chlorofluorocarbons and 12% ethylene oxide by weight. Chlorofiuorocarbons are at least partly responsible for the depletion of the ozone layer. For this reason, there must be proper protocols for cleaning, sterilizing, and packaging, with stringent quality control measures at each stage of the processing.

In the light of the problems associated with ethylene oxide as a sterilizing agent, interest has increased in a specially formulated buffered peracetic acid liquid with anticorrosives as a sterilant. This agent has a high germicidal effect, a fast turnaround time of 30 minutes, and does not have the toxic effects of ethylene oxide. 4s However, its efficacy in sterilizing PTCA equipmen t remains to be established.

Cost benefit of equipment reuse. Potential cost savings are the major impetus for reusing PTCA equipment. Historically, one of the major reasons for developing disposable equipment was to counteract the escalating labor costs ofreprocessing. Expensive single-use items such as angiographic and balloon catheters have led to a reconsideration of this trend.

The Council of Health Technologies in Quebec 49 estimated that if diagnostic catheters were reused

five times, the potential savings would amount to $37.50 per procedure. Similarly, if PTCA catheters were reused three times, the estimated savings would be $750 per procedure. In a 10-month period, Plante et al., 2s in the only prospective study to date, estimated a savings of $82,500 in a reuse center compared with a single-use center in Canada. With 320 patients in the reuse center, the estimated savings was $258 per patient.

A major issue not previously addressed is that these savings may be offset by technical difficulties and costly adverse events. In the center tha t reused catheters, the operators used more guiding catheters, balloon catheters, and contrast volume for each patient (Table I). In addition, the procedure time was 20% longer than in the single-use center. Further- more, the incidence of late closure and urgent coronary artery bypass surgery was significantly higher in the reuse center. The cost of treating these complications at the rates described by Plante et al. may outweigh potential savings from catheter reuse. 28 The higher complication rates in the reuse center, however, could be partly explained by the higher proportion of patients with acute coronary syndrome. Nonetheless, it is certain tha t the potential for savings in a reuse program largely depends on complication rates.

In considering reuse of PTCA catheters, two other cost issues are important. First, the actual cost of the catheters has a significant impact on the potential for savings. The maximum possible savings is the

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actual cost of the PTCA catheter. However, the quality of the catheters deteriorates after each use, and only about 80% of catheters are estimated to be re- usable. In addition, if the absolute cost of the catheters is low, especially when compared with the cost of the entire procedure, reuse may not be particularly cost effective. A second consideration is the number of times that a catheter can be reused. The Council of Health Technologies in Quebec 49 estimated that most cost savings is obtained after two reuses, with small increments after each additional reuse (Fig. 1). Reuse might also entail setting up a tracking system for each catheter. Collecting such information be- comes expensive and reduces the potential for savings when reusing catheters. With these limitations in the Canadian study, 2s proper determination of relative costs and savings requires a randomized prospective trial.

Ethical and medicolegal issues. During reuse, the key ethical considerations are patient safety and how to allocate single-use and reused equipment to patients. In vitro and in vivo studies suggest that reused angiographic catheters are not associated with increased risk for equipment breakage, particulate embolization, infection, endotoxic reactions, or toxicity. Nonetheless, a comprehensive program regarding reuse must be formulated. At the institution level, the reuse policy and resource allocation must be endorsed and clearly stated by the board of direc- tors and relevant professional staff. These procedures may in part address the genuine concern of exorbitant litigation if a mishap occurs with reused equipment.

Catheter reuse may be limited by patient accep- tance. One suggestion for making the concept of reuse more appealing is to reuse the catheter in the same patient. This practice would allay the fear of infection. After each procedure, the catheter could be cleaned, sterilized, packaged, and given to the patient. This is not an unreasonable strategy, because approximately 20% of patients have to undergo repeat PTCA in less than 6 months because of re- s~enosis. 2

Conclusion. Cost savings from reusingPTCA equip- raent may be substantial. Existing experimental and clinical data suggest that catheter reuse is not associated with an increased risk of equipment breakage, particulate body embolization, infection, endotoxic reactions, or toxicity. However, it remains to be demonstrated whether reused catheters are as effective as new catheters. The only clinical s tudy reported to date found increased complication rates with catheter reuse that can be proved to be quite expensive. In addition, other issues such as who

should receive a reused catheter and medicolegal liability must also be considered. Therefore in the light of the decreasing cost of balloon catheters and the current lack of randomized studies, there appears to be insufficient justification to consider reusing percutaneous equipment for revascularization in the United States.

Summary. The reuse of equipment for percutaneous coronary intervention is common in countries outside the United States. However, little is known about the risks or cost savings afforded by this practice. In vitro and in vivo studies suggest that reusing balloon angioplasty catheters and related equipment is not associated with increased risk of particulate body embolization, infection, endotoxic reaction, or toxicity. However, the only prospective, nonrandom- ized clinical trial of catheter reuse suggests that this practice may be associated with a lower success rate in crossing lesions, longer procedur e times, and higher complication rates. Cost-benefit modeling demonstrates that these factors potentially offset any cost savings afforded by catheter reuse.

We thank Tom Lang, Manager of the Medical Edit ing Services, for editorial assis tance in prepar ing the manuscr ipt .

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45. Kundsin RB, Walter CW. Detection of endotoxin on sterile catheters used for cardiac catheterization. J Clin Microbiol 1980;11:209-12.

46. Jordy A, Hedstuck W, Reinisch S. Residues and reaction products of devices sterilized with ethylenoxide (abstract). Hyg Med 1984;11: 247-9.

47. Fowler ME. Reuse of disposable items: liability is the key issue, Part II: cross-contamination. Plast Surg Nurs 1979;9:79.

48. Malchesky PS. Peracetic acid and its application to medical instrument sterilization. Artif Organs 1993;17:147-52.

49. Conseil d'6valuation des technologies de la sant6 du Qu6bec. The reuse of single-use cardiac catheters: safety, economical, ethical and legal issues. Can J Cardiol 1994;10:413-21.

1996 CERTIFICATION EXAMINATION IN CLINICAL CARDIAC ELECTROPHYSIOLOGY

Registration period: Jan. 1- April 1, !996

Examination date: Nov. 20, 1996

For information and application forms, please contact Registration Section, American Board of Internal Medicine, 3624 Mar- ket St., Philadelphia, FA 19104; telephone (800) 441-2246 or (215) 243-1500; fax (215) 382-5515.

Documents

Reuse of coronary angioplasty equipment: Technical and clinical issues