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Special Article

The Use of Angioplasty, Bypass Surgery, and Amputation in the Management of Peripheral Vascular Disease

Sean R. Tunis, M.D., M.Sc, Eric B. Bass, M.D., M.P.H., and Earl P. Steinberg, M.D., M.P.P.

N Engl J Med 1991; 325:556-562August 22, 1991

Abstract
Abstract

Background.

Percutaneous transluminal angioplasty has been adopted widely as a treatment for patients with peripheral vascular disease of the lower extremities. However, the effect of this procedure on the overall management of peripheral vascular disease and on the outcomes of patients has not been clearly delineated. In particular, it is not known whether angioplasty has replaced other treatments for peripheral vascular disease.

Methods.

To assess the extent to which angioplasty is used and the associated changes in the surgical management of peripheral vascular disease of the lower extremities, we used data on hospital discharges in Maryland to identify all angioplasty procedures, peripheral bypass operations, and lower-extremity amputations performed for peripheral vascular disease in Maryland hospitals between 1979 and 1989.

Results.

We estimate that from 1979 to 1989 the annual rate of percutaneous transluminal angioplasty for peripheral vascular disease of the lower extremities, adjusted for age and sex, rose from 1 to 24 per 100,000 Maryland residents (P<0.0001 by linear regression). Despite this increase in the use of angioplasty, the adjusted annual rate of peripheral bypass surgery also rose substantially, from 32 to 65 per 100,000 (P<0.001), whereas the adjusted annual rate of lower-extremity amputation remained stable at about 30 per 100,000. Total charges for hospitalizations during which a peripheral revascularization procedure was performed increased from $14.7 million in 1979 (in 1989 dollars) to $30.5 million in 1989.

Conclusions.

In Maryland, the adoption of percutaneous transluminal angioplasty for peripheral vascular disease of the lower extremities has been associated with an increase in the use of peripheral bypass surgery and with no decline in lower-extremity amputations. These results could be due to increased diagnosis of peripheral vascular disease, expanded indications for procedural interventions, or an increased number of repeat procedures performed in patients with peripheral vascular disease of the lower extremities. (N Engl J Med 1991; 325:556–62.)

Media in This Article

Figure 1Approach Used to Identify Procedures Performed for Peripheral Vascular Disease of the Lower Extremities in Maryland Hospital-Discharge Data.
Figure 2Adjusted Annual Rates of Angioplasty, Bypass Surgery, and Amputation for Peripheral Vascular Disease of the Lower Extremities in Maryland, 1979 through 1989.
Article

OVER the past two decades, percutaneous transluminal angioplasty has emerged as a popular alternative to peripheral bypass surgery for many patients with peripheral vascular disease of the lower extremities.1 2 3 4 Advocates of angioplasty contend that, as compared with bypass surgery, it reduces morbidity, mortality, and expense.5 6 7 Other experts have been concerned, however, that the improvement in circulation achieved with angioplasty may not last as long as that achieved with bypass surgery and, therefore, that angioplasty may be less effective and ultimately more costly than bypass surgery.8 9 10 In addition, some experts have been concerned that because angioplasty is less invasive than surgery, physicians may be inclined to perform the procedure in patients whose symptoms are too mild to warrant procedural intervention of any type, or in whom peripheral vascular disease is too extensive for angioplasty to be effective.8 , 11

Unfortunately, relatively little is known about the actual pattern and extent of adoption of percutaneous transluminal angioplasty for the treatment of peripheral vascular disease of the lower extremities, or about its effect on the surgical management of peripheral vascular disease. In one small study from England, the frequency of bypass surgery was found to remain stable during the period in which percutaneous transluminal angioplasty was introduced.12 In two other studies, increased use of angioplasty for peripheral vascular disease was associated with an increase in the use of peripheral bypass surgery and a decrease in lower-extremity amputations.13 , 14 Because each of these studies was based on data from a single institution, it is difficult to generalize about the impact of percutaneous transluminal angioplasty on patients with peripheral vascular disease of the lower extremities.

To assess the extent to which angioplasty has been adopted and its effects in a large, geographically defined population of patients with peripheral vascular disease of the lower extremities, we examined the rate and pattern of use of percutaneous transluminal angioplasty in the state of Maryland between 1979 and 1989; we also investigated the association between the adoption of angioplasty in Maryland and the use of bypass surgery for peripheral vascular disease of the lower extremities, the performance of lower-extremity amputations for peripheral vascular disease, and total hospital charges and the number of hospital days related to revascularization procedures for the management of peripheral vascular disease.

Methods

Our data were derived from a data base maintained by the Maryland Health Services Cost Review Commission (HSCRC), which contains information on all patients discharged from nonfederal, short-stay hospitals in the state of Maryland. For each hospitalization, information is provided on the patient's age, sex, race, length of hospital stay, hospital charges, and ZIP Code of residence, as well as the codes from the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) for up to five diagnoses and three procedures.

Using the Maryland HSCRC data, we obtained discharge abstracts for all patients 25 years of age or older who were discharged between January 1979 and December 1989 with a procedure code listed for lower-extremity bypass surgery (ICD-9-CM code 39.25 or 39.29), major lower-extremity amputation (code 84.12, 84.15, or 84.17), or other vessel repairs (code 39.59), the category that includes percutaneous transluminal angioplasty of a lower extremity. Although the codes for peripheral bypass surgery and lower-extremity amputations are specific to those procedures, the 39.59 code is not used exclusively for percutaneous transluminal angioplasty of the lower extremities. For example, renal angioplasty and intraoperative vessel repairs are also coded as 39.59. To exclude procedures assigned to code 39.59 that were probably not percutaneous transluminal angioplasty, we excluded cases that included codes for extracorporeal circulation, a surgical-graft complication, or peripheral bypass surgery in addition to code 39.59 (Fig. 1Figure 1Approach Used to Identify Procedures Performed for Peripheral Vascular Disease of the Lower Extremities in Maryland Hospital-Discharge Data.).

Diagnostic Criteria for Peripheral Vascular Disease of the Lower Extremities

Since the focus of our analysis was the interventional management of peripheral vascular disease of the lower extremities, we sought to exclude procedures that were performed for other conditions. To accomplish this, we developed an algorithm based on discharge diagnoses that divided procedures into three subgroups according to whether peripheral vascular disease was "likely," "possible," or "unlikely" in the patient in question (Fig. 1).

Procedures were considered likely to have been performed for peripheral vascular disease if the patient's primary diagnosis or any secondary diagnosis explicitly mentioned vascular disease; examples are diabetes mellitus with peripheral vascular complications, atherosclerosis of an extremity, peripheral angiopathy with another disease, peripheral vascular disease, embolism or thrombosis of the lower extremity, or arterial occlusive disease. Procedures performed during a hospitalization in which the patient did not have either a primary or a secondary diagnosis that explicitly mentioned vascular disease were considered possibly related to peripheral vascular disease if there was a primary or secondary diagnosis that is often, but not always, associated with the disease. For example, a lower-extremity amputation associated with diabetes mellitus was considered possibly related to peripheral vascular disease because lower-extremity amputations, which in diabetic patients are often performed because of peripheral vascular disease, may also be performed because of peripheral neuropathy.15 Other diagnoses considered to indicate the possible presence of peripheral vascular disease were atherosclerosis of the aorta, cellulitis of the toe or foot, ulcer of the lower limbs, osteomyelitis of the lower extremity, gangrene, or surgical complication of a graft. The remaining procedures, which were associated with none of the "likely" or "possible" diagnosis codes, were considered to be unlikely to be related to peripheral vascular disease and were excluded from our analysis.

Validation of the Identification of Angioplasty Procedures

To estimate the accuracy with which our algorithm identified percutaneous transluminal angioplasty performed for lower-extremity peripheral vascular disease, we reviewed discharge data submitted to the Maryland HSCRC on all patients discharged from Johns Hopkins Hospital between June 1988 and December 1989 who had a 39.59 procedure code and a diagnosis code considered to be explicitly related to peripheral vascular disease. These data were compared with reports that were independently maintained by the Johns Hopkins Department of Radiology for all patients who underwent angioplasty of the lower extremities at Johns Hopkins Hospital between June 1988 and December 1989. Hospital charts were then reviewed to determine the reasons for all discrepancies between the two lists of potential cases of angioplasty.

Of the 152 angioplasty procedures identified from the Department of Radiology records, 119 (78 percent) were also identified in the abstracted hospital-discharge data as having a procedure code of 39.59, a diagnosis classified by us as explicitly related to peripheral vascular disease, and as meeting none of the criteria we used to classify vessel-repair procedures as something other than percutaneous transluminal angioplasty. Of the 33 cases on the Department of Radiology list that were not identified with use of discharge abstracts, 26 had an incorrect procedure code listed on the discharge abstract and 7 did not have a diagnosis explicitly related to peripheral vascular disease. We identified only nine patients discharged from Johns Hopkins Hospital whom we would have classified as having undergone percutaneous transluminal angioplasty "explicitly related to peripheral vascular disease" who were not listed in the Department of Radiology file of lower-extremity angioplasty procedures. On review of the charts, five of these patients were found to have undergone embolectomy, and four to have undergone renal angioplasty. This small validation analysis thus suggests that the approach we used to identify angioplasty of the lower extremities was generally successful in excluding other types of vessel-repair procedures but that we may have slightly underestimated the number of cases of lower-extremity angioplasty.

Hospital Days and Charges for Revascularization Procedures

For each year between 1979 and 1989, we summed hospital days and total hospital charges for hospitalizations during which percutaneous transluminal angioplasty or peripheral bypass surgery was performed for lower-extremity peripheral vascular disease. These totals were adjusted for age by direct standardization. Total charges for each year were converted to 1989 dollars by adjusting for inflation on the basis of the increase in the health care component of the consumer price index during this period, as reported by the U.S. Bureau of Labor Statistics.16

Statistical Analysis

In our primary analyses, we focused on procedures that were likely to have been performed for lower-extremity peripheral vascular disease. In secondary analyses, we examined procedures that were likely to be related or possibly related to this condition. In both our primary and our secondary analyses, we determined the crude rates of angioplasty, bypass surgery, and amputation for each year from 1979 through 1989. Adjustments for age and sex were then carried out by direct standardization, with use of the 1980 Maryland census figures for people over the age of 24 as the standard population and yearly estimates of the population stratified by age and sex that we obtained from the Maryland Department of State Planning.

Differences between groups in demographic variables were assessed with the continuity-corrected chi-square test or Student's t-test for continuous variables. Least-squares linear regression was used to examine changes in rates of procedures over time. All P values reported are two-tailed. Statistical calculations were performed with the Statistical Applications Software of the SAS Institute.17

Results

Identification of Procedures Performed for Peripheral Vascular Disease

Figure 1 summarizes the number of angioplasty procedures, peripheral bypass operations, and amputations that we identified from the Maryland HSCRC data, as well as the proportion of each that we classified as likely to be related, possibly related, or unlikely to be related to peripheral vascular disease of the lower extremities. The cases of percutaneous transluminal angioplasty that were classified as unlikely to be related to this condition had primary discharge diagnoses that included traumatic injuries, myocardial infarction, renal atherosclerosis, and carotid-artery disease. The majority of the peripheral bypass operations classified as unlikely to be related to peripheral vascular disease were associated with a primary discharge diagnosis of abdominal aortic aneurysm, lower-extremity aneurysm, or renal failure. Lower-extremity amputations that were classified as unlikely to be related to peripheral vascular disease were most commonly associated with a primary discharge diagnosis of decubitus ulcer, lower-extremity trauma, or cancer.

The most common primary discharge diagnosis of the patients who underwent peripheral bypass surgery or percutaneous transluminal angioplasty that was likely to be related to lower-extremity peripheral vascular disease was "thrombosis or embolism of the lower extremity" (code 444.22). Although this code is not clinically precise, guidelines for coding instruct coders to include in this category any type of lower-extremity occlusion or obstruction, including peripheral vascular disease.18 The most common primary discharge diagnosis of patients who underwent lower-extremity amputation was "diabetes mellitus with peripheral vascular complication."

Characteristics of Patients

The demographic characteristics of the patients identified as having undergone percutaneous transluminal angioplasty, peripheral bypass surgery, or amputation likely to be related to lower-extremity peripheral vascular disease are shown in Table 1Table 1Demographic Characteristics of Patients Who Underwent Angioplasty, Bypass Surgery, or Amputation of the Lower Extremity Likely to Be Related to Peripheral Vascular Disease.. Although the patients presumed to have undergone angioplasty were slightly younger than those who underwent bypass surgery, the patients who underwent amputation were substantially older than those treated with either bypass surgery or angioplasty. Between 1979 and 1989, the average age of the patients who underwent angioplasty increased from 59.8 to 65.7 years (P<0.05 by t-test), and the average age of those who underwent bypass surgery increased from 64.1 to 67.2 years (P<0.0001 by t-test). The average age of the patients who underwent amputation did not change during this period. A greater proportion of these patients were female and black than of those who underwent bypass surgery or angioplasty. Black patients also accounted for a higher percentage of the patients who underwent bypass surgery than of those who underwent angioplasty.

Number of Procedures

Table 2Table 2Angioplasty Procedures, Bypass Operations, and Amputations Performed for Peripheral Vascular Disease (PVD) of the Lower Extremities in Maryland Hospitals, 1979 through 1989. presents our estimates of the number of angioplasty procedures, peripheral bypass operations, and major amputations that were performed for likely or possible peripheral vascular disease of a lower extremity. Between 1979 and 1989, the number of cases of lower-extremity angioplasty likely to be related to peripheral vascular disease increased from 17 to 706 per year, an increase of 689 procedures per year. Over the same period, the number of lower-extremity bypass operations per year increased by 1268, nearly twice as much as the increase in peripheral angioplasty. Despite the nearly 2000 additional angioplasty procedures and bypass operations performed in 1989, the number of major lower-extremity amputations performed for likely peripheral vascular disease in 1989 exceeded the number performed in 1979 by 206. Thus, the total number of angioplasty procedures, bypass operations, and amputations performed in 1989 (3799) was more than twice the number performed in 1979 (1636). Although percutaneous transluminal angioplasty accounted for only 2 percent of the revascularization procedures (angioplasty and peripheral bypass) performed in 1979, it accounted for 25 percent of such procedures by 1989. Table 2 also shows that the direction and magnitude of these trends were very similar when procedures that were performed for either likely or possible peripheral vascular disease were included in the analysis.

Eighty percent of the peripheral bypass procedures that we identified as having been performed in 1979 for what was likely to be peripheral vascular disease were "distal" procedures (femoral-femoral, femorotibial, and others), and approximately 20 percent were "proximal" procedures (aortoiliac, aortofemoral, iliofemoral, and others). By 1989, 85 percent of the peripheral bypass operations likely to be related to peripheral vascular disease were distal procedures (P<0.001 by chi-square test). There was no significant change between 1979 and 1989 in the proportion of lower-extremity amputations related to peripheral vascular disease that were performed above the knee as compared with the proportion performed below the knee (data not shown).

Rates of Procedures

Rates of angioplasty, peripheral bypass surgery, and lower-extremity amputation from 1979 through 1989, adjusted for age and sex, are shown in Figure 2Figure 2Adjusted Annual Rates of Angioplasty, Bypass Surgery, and Amputation for Peripheral Vascular Disease of the Lower Extremities in Maryland, 1979 through 1989.. Between 1979 and 1989, the rate of angioplasty rose from 1 to 24 per 100,000 (P<0.0001 by linear regression). Over the same period, the rate of peripheral bypass surgery doubled, from 32 to 65 per 100,000 (P<0.001), and the rate of amputation was stable at between 28 and 32 per 100,000 (P = 0.7).

All these rates were recalculated after we included procedures associated with either a likely or a possible diagnosis of lower-extremity peripheral vascular disease. When this expanded list was used, the annual rates of bypass surgery and amputation were about 13 percent and 35 percent higher, respectively, for each year in the study, resulting in trend lines parallel to those shown. The rates of angioplasty were not significantly affected by the inclusion of procedures that were possibly related to peripheral vascular disease. In no case did the use of the broader set of inclusion criteria alter the direction or the statistical significance of the findings reported.

Approximately 6 percent of all procedures related to peripheral vascular disease that were performed in Maryland hospitals involved patients whose primary residence was outside Maryland. There was no change in this percentage over the study period.

Hospital Charges and Hospital Days

Hospital charges, adjusted for patients' age and inflation, and the number of hospital days, adjusted for age, for admissions during which angioplasty or a bypass operation was performed for likely peripheral vascular disease of the lower extremities are shown in Table 3Table 3Total Hospital Charges and Number of Hospital Days Associated with Angioplasty and Peripheral Bypass Procedures Performed for Peripheral Vascular Disease of the Lower Extremities in Maryland.* for the years 1979, 1984, and 1989. In 1989, Maryland hospitals generated about $15.8 million more (in 1989 dollars) in charges for admissions associated with peripheral revascularization procedures than in 1979, and patients spent more than 13,000 additional days in the hospital during admissions in which these procedures were performed.

Providers

In 1979, of a total of 52 nonfederal, short-stay hospitals in Maryland, there were only 2 in which more than five angioplasty procedures were performed for what was likely to be peripheral vascular disease of a lower extremity. By 1987, five or more such procedures were performed in 17 Maryland hospitals, and in 1989 there were 30 hospitals in which at least five angioplasty procedures were performed for peripheral vascular disease. About half the angioplasty procedures in 1989 were performed in 5 high-volume institutions; the remainder were fairly evenly distributed among the other 25 hospitals. By comparison, the number of hospitals in Maryland in which five or more peripheral bypass operations were performed per year increased only slightly over the same period, with 36 hospitals performing five or more in 1979 and 41 hospitals performing five or more in 1989.

Discussion

In 1984, using economic modeling techniques, experts predicted that the use of percutaneous transluminal angioplasty instead of peripheral bypass surgery as the first intervention in appropriately selected patients with peripheral vascular disease would substantially reduce the need for bypass surgery and result in an annual national savings of 352 lives, $82 million, and an additional 5006 limbs in which the graft remained patent.7 Previous studies have reported that the documented increase in the use of percutaneous transluminal angioplasty has been accompanied by either an increase or no change in the volume of peripheral bypass surgery and either a decrease or no change in rates of amputation.12 13 14 These studies focused on the experience of single referral institutions that performed a relatively small number of revascularization procedures. Consequently, their results could reflect changes in referral patterns or institutional practice policies, rather than true changes in the overall rates of procedures related to peripheral vascular disease.

In order to evaluate the experience of a large number of patients cared for at a number of hospitals, we analyzed 11 years' worth of abstracted discharge data from all 52 nonfederal, short-stay hospitals in Maryland. Our analysis showed that a dramatic increase in the rate of use of percutaneous transluminal angioplasty between 1979 and 1989 was accompanied by a doubling in the rate of use of peripheral bypass surgery, no major change in the rate of lower-limb amputations, and a substantial increase in the number of hospital days and in the total charges associated with revascularization procedures. These results suggest that some of the anticipated clinical and economic benefits associated with the wide use of angioplasty may not have been realized.

In the evaluation of our results, several potential factors related to our use of an administrative data base should be considered. The first concerns the accuracy of coding of diagnoses and procedures in the data base. A recent audit of discharge records submitted to the Maryland HSCRC found a rate of coding errors of 5 to 10 percent for major procedures (unpublished data). This low rate of coding errors is unlikely to have produced an important bias in our findings, especially since many of the errors that are detected in such audits involve improper sequencing of codes or failure to code complications, rather than the use of improper codes.19

A second concern is that because there is often a delay in the assignment of unique ICD-9-CM codes to new procedures, percutaneous transluminal angioplasty of the lower extremities still lacks a specific code. This fact necessitated our use of an algorithm to identify such procedures. As our validation analysis confirmed, this algorithm was designed in a way that was more likely to fail to identify a case of angioplasty that was actually performed than to identify falsely some other procedure as percutaneous transluminal angioplasty. Given the resulting likelihood that we have underestimated the true rate of angioplasty, our findings that the rate of bypass surgery increased and the rate of amputation remained unchanged despite the increased use of angioplasty are even more striking. Although improved accuracy over time in coding percutaneous transluminal angioplasty could have contributed to the increase we observed in the number of angioplasty procedures performed, it would not have affected our findings about the rates of bypass or amputation. Telephone contact with 10 of the hospitals identified in our data as having begun to perform percutaneous transluminal angioplasty since 1987 confirmed the addition of new radiologic facilities or personnel for the interventional management of peripheral vascular disease since 1986.

A third concern is that our primary analysis may have excluded some patients who underwent angioplasty, bypass, or amputation for peripheral vascular disease of the lower extremities but who did not have a diagnosis that we considered likely to be related to peripheral vascular disease listed in their discharge abstracts. To address this concern, we performed a secondary analysis, in which we include diagnoses with a likely or possible association with peripheral vascular disease. This secondary analysis did not alter any of the conclusions drawn from our primary analysis.

Fourth, changes over time in the number of patients traveling into or out of Maryland for vascular procedures could have distorted the trends in procedure rates that we observed. No substantial changes in the movement of patients into or out of Maryland for hospital care have occurred over the past decade, however. Moreover, when we examined information on

patients' ZIP Codes in our data base, we saw no change in the fraction of patients who underwent procedures related to peripheral vascular disease in Maryland hospitals who lived outside of Maryland. No data were available on the number of patients who left Maryland for the treatment of peripheral vascular disease.

Fifth, our analysis of the total hospital charges and the number of hospital days associated with hospitalizations during which angioplasty or bypass surgery was performed was limited by the fact that we had no way of distinguishing the resources devoted to the management of peripheral vascular disease from those expended on the management of other problems. In addition, we were unable to determine professional fees or to determine what resources were expended on the outpatient management of peripheral vascular disease. Although estimates of charges and hospital days associated with hospitalizations during which angioplasty or bypass surgery was performed for peripheral vascular disease do not optimally reflect the resources expended in managing this condition, it is virtually certain that the substantial increase we observed in the number of angioplasty procedures, bypass operations, and amputations performed for what was likely to be peripheral vascular disease has been associated with an increase in expenditures for the treatment of such disease.

A final concern is that our results were derived from a single state and hence may not be generalizable to other parts of the country. Although this is true, we believe our analysis of the experience in all the nonfederal, short-stay hospitals in Maryland is more likely to be representative than are data from any single medical center, particularly a referral center.

There are several possible explanations for the increase in bypass surgery that we observed in association with the increased use of percutaneous transluminal angioplasty. First, there may have been an increase in the incidence of peripheral vascular disease over the past decade. A variety of epidemiologic data suggest that such an increase is unlikely to have occurred between 1979 and 1989, however.20 21 22 23 Of most relevance are data recently reported from the Framingham Heart Study that demonstrated no change in the frequency of intermittent claudication among men who were 50 to 59 years of age in 1970, as compared with men who were 50 to 59 years of age in 1950.20 Although the incidence of peripheral vascular disease may not have changed, a more probable explanation is that the availability of less invasive therapy — namely, percutaneous transluminal angioplasty —could have prompted an increase in the detection of peripheral vascular disease through more aggressive evaluation of patients with lower-extremity symptoms. The availability of angioplasty may also have prompted physicians to intervene in the presence of less advanced disease than in the past, when surgery was the only procedural option.4 , 5 , 11 , 13 , 14

Some of the increase in the rate of bypass surgery that we have observed may also be due to the adoption of broader indications for bypass surgery. Because of technical advances, improved long-term patency of grafts, and lower operative morbidity and mortality, vascular surgeons may have become more willing to operate on patients who would previously not have been considered candidates for surgery.24 , 25

Another possible explanation for the increase in revascularization procedures is that patients who would have undergone a single bypass operation in 1979 may have undergone more than one angioplasty procedure, angioplasty in addition to bypass surgery, or more than one bypass procedure in the 1980s. Such a change could result from several factors: the early or late failure of angioplasty, followed by the need for peripheral bypass10 , 26; exacerbation of peripheral vascular disease by angioplasty; performance of angioplasty after the early or late failure of bypass surgery14 , 27 , 28; the combination of distal bypass surgery with angioplasty at a more proximal anatomical location29; or the performance of several bypass procedures in the same patient.30 Although patency rates after angioplasty are reported to be as high as 80 percent at five years,3 , 4 , 31 32 33 the results may be less impressive in general clinical experience than in published data from referral centers.

Because of the lack of unique patient identifiers in the Maryland HSCRC data base, we were not able to determine the frequency with which individual patients underwent more than one procedure for peripheral vascular disease of the lower extremities between 1979 and 1989. Clinicians at Montefiore Medical Center in New York, however, recently reported that 44 percent of all patients treated with percutaneous transluminal angioplasty between 1979 and 1989 also underwent peripheral bypass surgery.14 The average number of procedures performed for peripheral vascular disease per patient at Montefiore rose from 1.2 in 1974 to 1.6 in 1980 through 1984, and to 1.8 in 1985 through 1989.14 In addition, a prospective study of 370 patients initially treated with percutaneous transluminal angioplasty in 1980 through 1987 and followed for an average of seven years showed that 35 percent of the patients underwent two or more angioplasty procedures, and 29 percent underwent bypass surgery after the failure of angioplasty.34

Limb salvage is considered one of the primary goals of the interventional management of peripheral vascular disease.35 , 36 Although studies of trends in the management of peripheral vascular disease at single institutions have reported decreased rates of amputation in association with an increase in the use of lower-extremity revascularization,13 , 14 population-based studies have not confirmed this association.37 , 38 In a study of data from the National Center for Health Statistics, Ernst et al. reported that the use of peripheral bypass surgery increased 56 percent between 1979 and 1984, whereas rates of lower-extremity amputation (including amputation of a toe) increased 45 percent during the same period.37 The failure of increased numbers of revascularization procedures to decrease the rates of amputation in Maryland could reflect an increasingly aggressive but ineffective interventional approach to disease that is either too mild or too advanced to be associated with an increase in limb salvage. Although the salvage of limbs is one of the most important justifications for the revascularization of the lower extremities, other outcomes are also relevant. For example, the increased number of angioplasty and bypass procedures performed in Maryland over the past decade may have reduced patients' discomfort and improved their functional status — outcomes that we could not detect with the HSCRC data base.

Interestingly, studies of the association between the introduction of percutaneous transluminal coronary angioplasty and changes in the use of coronary-artery bypass—graft surgery and mortality from coronary heart disease reveal a pattern of change similar to that demonstrated in our analysis of the treatment of peripheral vascular disease.39 40 41 42 43 44 That is, during the period when percutaneous transluminal coronary angioplasty was being adopted, there was a sharp increase in the performance of coronary-artery bypass surgery40 , 44 and no reduction in mortality from coronary heart disease. The similarity of these trends probably reflects parallel developments in the technology used to treat both peripheral vascular disease and coronary heart disease and the expansion of the indications for angioplasty and bypass surgery, regardless of the type of vessel involved.

Supported in part by a grant (2 T32 HL07180) from the National Heart, Lung and Blood Institute.

We are indebted to Gerard Anderson, Ph.D., Bruce Perler, M.D., Malonnie Kinnison, M.D., and William Hiatt, M.D., for their insightful comments on the manuscript; to Robert Herbert, B.Sc, for assistance with programming; to Michael Klag, M.D., M.P.H., for statistical advice; and to Paul Allen, Lillian Shockney, Lori Willard, and David Mihaly for assistance with discharge-coding practices and the angioplasty validation analysis.

Source Information

From the Johns Hopkins Program for Medical Technology and Practice Assessment, 1830 E. Monument St., Rm. 8068, Baltimore, MD 21205, where reprint requests should be addressed to Dr. Steinberg.

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