Catheterization and Cardiovascular Diagnosis 27:179-182 (1992)

Balloon Catheter Requirements During Contemporary Percutaneous Transluminal Coronary Angioplasty Joel K. Kahn, MD In order to examine the outcome of utilizing multiple balloon catheters during the percutaneous transluminal coronary angioplasty (PTCA), 300 consecutive PTCAs were analyzed. PTCA was performed in a single lesion in 163 patients (%%), In multiple lesions in 52 patients (18%), and in multlple vessels in 85 patients (28%). A total of 488 balloon catheters were used (lbkase, range 1-9) and in 112 cases (37%) 2 2 catheters were used. Multiple balloon catheters were needed in 27 single lesion (17%), 24 muitilesion (48%), and 61 multivessel (72%) cases (p < .05). There was no difference in the angiographic success rate in cases completed with 1 balloon catheter (238/251, 95%0) compared to those requiring 2 2 catheters (2601274, 9570). Emergency bypass was required in 5 patients (1.7%) and there were 2 deaths (0.6%). Thus, although contemporary PTCA frequently requires multiple balloon catheters for completion, success rates remain high and appear to offset the increased procedural expenses. D 1992 Wiiey-Liss, inc. Key words: coronary artery disease, cardiac catheterization, myocardial ischemia

corded. In all cases where multiple balloon catheters were used, the procedural dictation, and if necessary, the The number of patients treated with percutaneous procedural films, were reviewed to determine the reason transluminal coronary angioplasty (PTCA) has increased for using more than one balloon catheter. greatly in recent years. Initially patients with single vesAll patients were treated with sublingual or intravesel coronary artery disease (CAD) were selected for nous calcium antagonists at the time of PTCA. In genPTCA [ 11 and only a single balloon catheter was gener- eral, over-the-wire systems compatible with 0.014 inch ally required. Currently, patients with complex, diffuse, guidewires were initially selected for dilatation. In torand multivessel CAD are often considered candidates for tuous arteries with distally located stenoses, fixed wire PTCA [2,3]. Little information is available, however, catheters were the initial selection. Balloons were seregarding recent trends in equipment requirements. Furlected to provide a visually assessed 1:1 balloon to artery thermore, as individual PTCA balloon catheters cost beratio. Pre-dilatation of severe stenoses was routinely emtween $600 and $1000, the cost of treating patients with ployed only in PTCA of chronically occluded arteries, more advanced CAD may be considerable. The purpose where 2.0 mm low-profile over-the-wire catheters were of this study was to examine the hypothesis that proceselected as the initial equipment [4]. Autoperfusion baldural outcome is not diminished in cases requiring mulloons were employed as primary catheters in 6 patients tiple balloon catheters. (2%) with proximal stenoses in large arteries. Balloons were gradually inflated under fluoroscopic visualization until full relief of the stenosis was achieved, as previMATERIALS AND METHODS ously described [ 5 ] . Whenever feasible during multileBetween July 1990 and July 1991, 300 consecutive sion PTCA, individual balloon catheters were used on patients were treated with PTCA by the author. Clinical multiple lesion sites. Staged PTCA of stenoses within and procedural details were prospectively collected in a separate arteries to different days was performed only if PTCA database. Equipment requirements were determined by a retrospective review of catheterization laboratory record sheets. All equipment selected during From the Michigan Heart and Vascular Institute, St. Joseph Mercy PTCA was listed in the catheterization laboratory Hospital, Ann Arbor. records. Laboratory record sheets were reviewed for all Received February 28, 1992; revision accepted June 1 , 1992 300 study patients. The number of balloon catheters used, the balloon sizes selected, and whether an over- Address reprint requests to Joel K . Kahn, M . D . , 5333 McAuley the-wire or fixed-wire system was selected were re- Drive, Suite 3009, Ann Arbor, MI 48106. INTRODUCTION

0 1992 Wiley-Liss, Inc.

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TABLE 1. Clinical and Procedural Characteristics of 300 Consecutive Patients Treated With Coronary Angioplasty

TABLE II. An Analysis of Coronary Angioplasty Balloon Catheter Use in 300 Consecutive Patients

Male (%) Mean age. years (range) Age 2 7 0 years (%) Prior bypass surgery (%) Ejection fraction 540% (%) Acute infarction (%) Emergency angioplasty (%)

215 (72)

I balloon catheter (%) 2 balloon catheters (%) 3 balloon catheters (%) 4-6 balloon catheters (%) 7-9 balloon catheters (%) Total balloon catheters (meadcase)

Single lesion angioplasty (% pts) Multilesion angioplasty (% pts) Multivessel angioplasty (% pts) No. lesions attempted Lesion sucess (%)

163 (54) 52 (18) 85 (28) 525 498 (95)

*

59 13 (29-86) 63 (21) 49 (16) 28 (9) 25 (8) 41 (14)

a severe dissection developed in the initial site dilated or in the setting of PTCA for acute myocardial infarction. Multilesion PTCA was defined as PTCA of more than one discrete stenosis within a single epicardial arterial system. Multivessel PTCA was defined as PTCA of stenoses in separate epicardial arterial systems. Angiographic success was considered to be present when the visual assessment of the final angiographic result indicated a stenosis of 140% diameter narrowing. Patient success was defined as successful PTCA of all planned stenoses without complicating myocardial infarction, emergency bypass surgery, or death. Variables were analyzed with Fisher’s exact test or analysis of variance. A p value of 48 hours) total occlusions was attempted in 33 patients and

188 (63) 65 (21) 30 (10) 16 ( 5 ) 1 (1) 488 (1.6)

TABLE 111. An Analysis of the Reasons for Multiple Balloon Catheter Use in 112 Coronary Angioplasty Procedures Multivessel angioplasty (%) Multilesion angioplasty (%) Single lesion angioplasty (%) Sizing up of balloon catheter to match artery size (%) Dissection requiring perfusion balloon (%) Tortuosity requiring fixed-wire balloon (%) Balloon rupture (a)

61 (54) 24 (22) 27 (24) 14 (12) 5 (4) 5 (4) 3 (4)

was successful in 22 (67%). Multiple balloon catheters were used in 18 of the 22 successful cases (82%). A comparison of balloon catheter requirements for single lesion, multilesion, and multivessel PTCA is presented in Table IV. Although 28 of the multilesion cases (52%) and 24 of the multivessel cases (28%)were completed with a single balloon catheter, the average number of catheters used per case was greatest in multivessel PTCA (p < .05). Lesion success and patient success was similar among the three patient groups. Assuming a cost of $700 for each balloon catheter, the average balloon catheter expenditure was greater for multivessel PTCA than either multilesion or single lesion PTCA. A successful PTCA was achieved in 175 of 188 cases when a single catheter was used (93%), in 59 of 65 cases when 2 balloon catheters were used (91%), in 28 of 30 cases when 3 balloon catheters were used (93%), in 8 of 11 cases when 4 balloon catheters were used (73%),in 2 of 3 cases when 5 balloon catheters were used (67%), in 1 of 2 cases when 6 balloon catheters were used (50%), and in the 1 case when 9 balloon catheters were used (100%). Lesion success in the 188 cases when 1 balloon catheter was used was 238/25 1 (95%) and was similar to the success achieved in 260/274 (95%) lesion in the 112 cases when 2 2 balloon catheters were required (p = NS). Out of laboratory acute vessel closure occurred in 11 patients (4%). Overall, emergency bypass surgery was required in 5 patients (1.7%).Two patients with multivessel disease and poor left ventricular function died prior to hospital discharge (0.7%). D,SCUSS,ON

Several million people have been treated with PTCA since its introduction [l]. Large databases have provided

Balloon Use in PTCA TABLE IV. A comparison of Balloon Catheter Requirements in Single Lesion, Multilesion, and Multivessel Coronary Angioplasty

No. of pts/No. of lesions Balloon catheters used (meankase) 2 2 catheters used (%) Lesion success (96) Patients success (%) Average balloon catheter Cost/case*

Sinde lesion

Multilesion

Multivessel

163/163

52/113

85/249

214 (1.3)

83 (1.6) 24 (46) 111 (98) 1 1 1 (98) $1 120

191 (2.2) 61 (72) 238 (96)

27 (16) 148 (91) 148 (91)

$910

15 (88) $1540

*Assumes $700/balloon catheter.

information about the short and long term results of patients treated with PTCA. Relatively little information, however, is available regarding the technical aspects of the PTCA procedure. Just as the patient population eligible for PTCA has changed dramatically in recent years [2,3], the dilatation equipment currently in use has also undergone considerable changes. Contemporary balloon catheters offer reduced shaft and balloon profiles, greater burst strength, and enhanced trackability, frequently permitting even large balloons to cross and dilate severe obstructions. Balloon catheters, however, are also the most expensive disposable component of the equipment used during the PTCA procedure. The results of this study provide data relevant to the growing concern about the cost-effectiveness of medical procedures. The characteristics of patients in this study are similar to those in other studies [2,3] including a number of elderly patients, patients with multivessel disease, poor left ventricular function, prior coronary artery bypass graft surgery, and patients with acute and chronic occlusion of coronary vessels (Table I). This represents a considerable change from earlier series of PTCA when predominantly patients with single, proximal, non-calcified discrete coronary stenoses were selected for treatment [I]. As patients with more advanced CAD have been treated, the procedural demands have also increased. These demands frequently result in longer procedures involving considerable radiation exposure and contrast agent doses [6], and may also result in greater utilization of PTCA equipment within individual cases. Multivessel and multilesion PTCA were the most common reasons for multiple balloon catheter use. Onehalf of multilesion and one-quarter of multivessel procedures, however, were completed with a single balloon catheter. This was possible when multiple lesions within arteries of similar diameters were present. It was also often possible to treat stenoses in arteries 0.25-0.5 mm larger or smaller than the nominal balloon catheter dimension by selecting balloon catheters constructed with compliant balloon materials. This approach has certain

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limitations that need to be considered in each patient including the higher profile of catheters used previously to dilate other sites, the potential risk of severe dissection if an oversized balloon is used to treat a small vessel, and the potential consequences of high pressure inflations, such as balloon rupture, required to intentionally oversize compliant balloons. In many cases there was sufficient variability in target artery dimensions to require multiple catheters for safe dilatation. Even in single lesion PTCA multiple balloon catheters were often required. The most common reason was the selection of an initial balloon catheter that eventually was felt to be too small for complete dilatation. This, in part, reflects errors in visually estimating the arterial dimensions using a guiding catheter of known size as a reference marker. In other cases the administration of calcium antagonists and intracoronary nitroglycerin resulted in relaxation of coronary vasomotor tone and progressively larger arterial dimensions. It was also common to appreciate an increase in the dimensions of distal arterial segments after initial dilatations of severe stenoses. A larger balloon catheter was often necessary to achieve a successful PTCA. Another common reason for using multiple balloon catheters during PTCA was the attempted recanalization of chronic total occlusions in 33 patients. Generally a small (1.5 to 2.0 mm) balloon catheter was selected to maximize the chances of crossing the stenosis. If antegrade coronary flow was established, exchange for larger balloon catheters was often necessary. The cost of PTCA is being compared to medical therapy and coronary artery bypass grafting in ongoing randomized trials. In addition to hospital facility and professional charges, equipment charges contribute approximately $1,100 per case ranging from $700 to $5,600. The overall angiographic success rate remained high (95%) in cases requiring multiple balloon catheters. Arbitrary limits, therefore, on the number of balloon catheters permitted during PTCA might be counterproductive. Patients subsequently referred for coronary artery bypass grafting due to limits on balloon catheter use would be expected to considerably increase the overall hospital charges. Although catheters with tandem balloons of differing sizes have met with little clinical acceptance to date, they may eventually permit PTCA of arteries of different dimensions with a single catheter in a more cost effective manner. In summary, contemporary PTCA applied to a broad range of patients and coronary anatomy frequently requires the use of multiple balloon catheters. The requirement for multiple balloon catheters is particularly great during multivessel angioplasty. Although the requirement for multiple balloon catheters serves as a marker of complex PTCA procedures, angiographic success rates

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in these cases remain high with excellent clinical results. Arbitrary limits on the number of balloon catheters permitted per PTCA procedure may not necessarily limit hospital costs. REFERENCES 1 . Gruntzig AR, Senning A, Siegenthaler WE: Nonoperative dilatation of coronary artery stenosis. N Engl J Med 301:61-68, 1979. 2. Hartzler GO: PTCA in evolution: Why is it so popular? Cleve Clin J Med 57:121-124, 1990. 3. Tuzcu EM, Simpfendorfer C, Dorosti K, Franco I, Hollman J,

Badhwar K , Whitlow P Changing patterns in percutaneous transluminal coronary angioplasty. Am Heart J 117:1374-1377, 1989. 4. McKeever LS, O’Donnell MJ, Stamato NJ, Cahill JM, Hartmann JR, Marek JC, Brown AS, Enger EL: The effect of predilatation on coronary angioplasty-induced vessel wall injury. Am Heart J 122: 1515-1518, 1991. 5 . Kahn JK, Rutherford BD, McConahay DR, Hartzler GO: Inflation pressure requirements for coronary angioplasty. Cathet Cardiovasc Diagn 21:144-147, 1990. 6. Kahn JK, Rutherford BD, McConahay DR, Johnson WL, Giorgi LV, Hartzler GO: High dose contrast media administration during complex coronary angioplasty. Am Heart 1 120533-536, 1990.

Balloon catheter requirements during contemporary percutaneous transluminal coronary angioplasty.

In order to examine the outcome of utilizing multiple balloon catheters during the percutaneous transluminal coronary angioplasty (PTCA), 300 consecut...
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