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Changes in the Incidence of Lower Extremity Amputations in Individuals With and Without Diabetes in England Between 2004 and 2008

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To describe recent trends in the incidence of nontraumatic amputations among individuals with and without diabetes and estimate the relative risk of amputations among individuals with diabetes in England. We identified all patients aged >16 years who underwent any nontraumatic amputation in England between 2004 and 2008 using national hospital activity data from all National Health Service hospitals. Age- and sex-specific incidence rates were calculated using the total diabetes population in England every year. To test for time trend, we fitted Poisson regression models. The absolute number of diabetes-related amputations increased by 14.7%, and the incidence decreased by 9.1%, from 27.5 to 25.0 per 10,000 people with diabetes, during the study period (P > 0.2 for both). The incidence of minor and major amputations did not significantly change (15.7-14.9 and 11.8-10.2 per 10,000 people with diabetes; P = 0.66 and P = 0.29, respectively). Poisson regression analysis showed no statistically significant change in diabetes-related amputation incidence over time (0.98 decrease per year [95% CI 0.93-1.02]; P = 0.12). Nondiabetes-related amputation incidence decreased from 13.6 to 11.9 per 100,000 people without diabetes (0.97 decrease by year [0.93-1.00]; P = 0.059). The relative risk of an individual with diabetes undergoing a lower extremity amputation was 20.3 in 2004 and 21.2 in 2008, compared with that of individuals without diabetes. This national study suggests that the overall population burden of amputations increased in people with diabetes at a time when the number and incidence of amputations decreased in the aging nondiabetic population.
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Changes in the Incidence of Lower
Extremity Amputations in Individuals With
and Without Diabetes in England Between
2004 and 2008
ESZTER P. VAMOS,
MD, PHD
1
ALEX BOTTLE,
MSC, PHD
1
MICHAEL E. EDMONDS,
FRCP
2
JONATHAN VALABHJI,
MD, FRCP
3
AZEEM MAJEED,
MD, FRCGP
1
CHRISTOPHER MILLETT,
PHD, FFPH
1
OBJECTIVE — To describe recent trends in the incidence of nontraumatic amputations
among individuals with and without diabetes and estimate the relative risk of amputations
among individuals with diabetes in England.
RESEARCH DESIGN AND METHODS We identified all patients aged 16 years
who underwent any nontraumatic amputation in England between 2004 and 2008 using na-
tional hospital activity data from all National Health Service hospitals. Age- and sex-specific
incidence rates were calculated using the total diabetes population in England every year. To test
for time trend, we fitted Poisson regression models.
RESULTS The absolute number of diabetes-related amputations increased by 14.7%, and
the incidence decreased by 9.1%, from 27.5 to 25.0 per 10,000 people with diabetes, during the
study period (P0.2 for both). The incidence of minor and major amputations did not
significantly change (15.7–14.9 and 11.8–10.2 per 10,000 people with diabetes; P0.66 and
P0.29, respectively). Poisson regression analysis showed no statistically significant change in
diabetes-related amputation incidence over time (0.98 decrease per year [95% CI 0.93–1.02];
P0.12). Nondiabetes-related amputation incidence decreased from 13.6 to 11.9 per 100,000
people without diabetes (0.97 decrease by year [0.93–1.00]; P0.059). The relative risk of an
individual with diabetes undergoing a lower extremity amputation was 20.3 in 2004 and 21.2 in
2008, compared with that of individuals without diabetes.
CONCLUSIONS This national study suggests that the overall population burden of am-
putations increased in people with diabetes at a time when the number and incidence of ampu-
tations decreased in the aging nondiabetic population.
Diabetes Care 33:2592–2597, 2010
D
iabetic foot lesions remain a consid-
erable cause of morbidity and a
leading cause of hospitalization in
people with diabetes (1). Despite inten-
sive interventions, many of these patients
require a lower extremity amputation
(LEA), with high social impact and poor
clinical prognosis for the patients, as well
as considerable financial implications for
health care systems (2).
The number of people diagnosed as
having diabetes has more than doubled
over the last 10 years in England (3). As
the prevalence of diabetes increases due
to an aging population and an increasing
rate of obesity, an increase in the number
of amputations is to be expected. We have
recently reported that whereas the num-
ber of type 1 diabetes- and nondiabetes-
related LEAs decreased in England
between 1996 and 2005, there was a con-
sistent upward trend in type 2 diabetes-
related procedures (4). However, because
of the lack of accurate information on di-
abetes prevalence, particularly for the
early years of this period, we were unable
to calculate diabetes-specific LEA inci-
dence in England.
During the last decade, several initia-
tives have been undertaken in England to
improve diabetes management across pri-
mary, community, and secondary care
settings and specialist services (5,6). Cor-
responding with many studies from Eu-
rope and the U.S., a series of regional
studies and centers highly specialized in
diabetic foot care have shown significant
decline in the incidence of LEAs after spe-
cific interventions were instituted (7–13).
Others reported unchanged incidence of
amputations in people with diabetes de-
spite increasing vascular intervention
rates (14–16). However, most studies re-
port incidence rates from single centers
and small geographical areas, and these
data are unlikely to reflect national trends.
Furthermore, the relative risk of amputa-
tions in diabetes has been rarely studied,
particularly in larger geographical areas
or nationally.
The objective of this study was to as-
sess trends in nontraumatic LEAs among
people aged 17 years with and without
diabetes between financial years 2004
2005 and 2008 –2009 using national hos-
pital admission data from all National
Health Service (NHS) hospitals in En-
gland. We describe diabetes- and nondia-
betes-related incidence rates and assess
the relative risk of people with diabetes
undergoing a nontraumatic LEA (minor,
major, and any) compared with those
without diabetes in England.
RESEARCH DESIGN AND
METHODS We examined Hospital
Episode Statistics (HES) between the fi-
nancial years 2004–2005 and 2008
2009 for all NHS hospital trusts in
England. The HES dataset covers all inpa-
tient hospital activity and day case admis-
sions to NHS (public) hospitals across
England including private patients
treated in NHS hospitals. Surgical inter-
●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
From the
1
Department of Primary Care and Public Health, Imperial College London, London, U.K.; the
2
Diabetic Foot Clinic, King’s College Hospital, London, U.K.; and the
3
Department of Diabetes and
Endocrinology, St Mary’s Hospital, Imperial College Healthcare NHS Trust, London, U.K.
Corresponding author: Eszter P. Vamos, e.vamos@imperial.ac.uk.
Received 24 May 2010 and accepted 3 September 2010. Published ahead of print at http://care.
diabetesjournals.org on 10 September 2010. DOI: 10.2337/dc10-0989.
© 2010 by the American Diabetes Association. Readers may use this article as long as the work is properly
cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.
org/licenses/by-nc-nd/3.0/ for details.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby
marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.
Epidemiology/Health Services Research
ORIGINAL ARTICLE
2592 DIABETES CARE,VOLUME 33, NUMBER 12, DECEMBER 2010 care.diabetesjournals.org
ventions were defined using the Office of
Population Censuses and Surveys’ Classi-
fication of Surgical Operations (OPCS4)
codes that contains up to 12 procedure
fields. Data extracted for each hospital ad-
mission include patient demographics
(age and sex), length of hospital stay,
principal diagnosis, and up to 13 second-
ary diagnoses coded using the ICD-10.
All patients who underwent any LEA
between financial years 2004–2005 and
2008–2009 were identified through hav-
ing the procedure code for LEA in any
procedure field. Different amputation
codes during the same hospitalization on
the same limb were assigned as a single
procedure on the highest level. A con-
tralateral limb amputation during the
same admission was counted as a separate
amputation. Side and level of LEA were
recorded for each procedure (Z942 indi-
cates the right side and Z943 the left). A
minor amputation was defined as any
LEA distal to the ankle joint (OPCS4
codes X11.1, X11.2, X11.8, and X11.9); a
major amputation was defined as any LEA
through or proximal to the ankle joint
(OPCS4 codes X09.2–5, X09.9, X10.1– 4,
and X10.8–9). All traumatic LEAs, de-
fined by any trauma-related code of the
lower extremity in any diagnosis field
(S70–99, T00 –35, Wxx, and Xxx), were
excluded from our analysis. Diabetes sta-
tus was classified as no diabetes or type 1
or type 2 diabetes (ICD-10 code E10
E11) codes recorded in any diagnosis
field. Other forms of diabetes (ICD-10
E12–E14) were excluded.
When age-, sex-, and diabetes-
specific LEAs were examined in patients
with multiple admissions during the same
financial year, only first admissions were
used to derive patient characteristics. We
used a combination of date of birth, sex,
and full postcode to distinguish patients,
as these were the only identifiers available
for all years in this study.
Data on the number of people aged
17 years having a diagnosis of diabetes
in England were obtained from the Qual-
ity Management and Analysis System
(QMAS) for each study year (5). QMAS is
the financial database for the Quality and
Outcomes Framework (QOF), a national
pay for performance scheme for primary
care practices introduced in April 2004,
and contains diabetes counts and preva-
lence data for virtually all (99%) family
practices in England (5). For 2004–2005
and 2005–2006, when diabetes figures
were available for the total population, we
calculated diabetes prevalence for pa-
tients aged 17 years for both years, us-
ing the age- and sex-standardized
diabetes prevalence in children and
young adults reported by the Royal Col-
lege of Pediatrics and Child Health (17).
Diabetes-specific incidence rates were ex-
pressed per 10,000 people with diabetes.
Data for the age and sex distribution of
individuals with diabetes were obtained
from the Health Survey for England 2006
(3). When age- and sex-specific preva-
lence rates of known diabetes were calcu-
lated for the general population of
England, we assumed that the age and sex
distribution of the diabetic population re-
mained constant between 2004 and
2008. The estimated resident population
of England was used to calculate inci-
dence of amputations in individuals with-
out diabetes for each year and incidence
rates are expressed per 100,000 people
without diabetes.
Ethical approval
We have Section 251 approval from the
National Information Governance Board
for Health and Social Care (formerly
Section 60 approval from the Patient
Information Advisory Group) to hold
confidential data and analyze them for re-
search purposes. We also have approval
from the South East Research Ethics
Committee.
Statistical analysis
Statistical analyses were performed using
the Stata statistical package. Median
lengths of stay were compared by type of
LEA and diabetes status with the Brown-
Forsythe test (18). To test time trends in
LEA rates, we fitted separate Poisson re-
gression models for patients with and
without diabetes, using age, sex, and level
of amputation as independent variables.
We estimated relative risk of an individual
with diabetes undergoing a LEA (minor,
major, and any) compared with that of an
individual without diabetes.
RESULTS Over the study period be-
tween 2004 and 2008, there were 49,487
nontraumatic LEAs performed on 45,424
patients in England. Of all amputations,
51% occurred among people with diabe-
tes (59.6% of minor and 42.6% of major
LEAs). There was a considerable male ex-
cess of LEAs among people with diabetes
with the male-to-female ratio being nearly
twice that of people without diabetes
(male-to-female ratio diabetes 2.7 [95%
CI 1.7–3.7] and nondiabetes 1.4 [0.8
2.1]). Most LEAs occurred in individuals
aged 65 years (60.4% of diabetes-
related and 68.3% of nondiabetes-related
LEAs). Minor amputations were more
common than major LEAs in individuals
with diabetes, whereas there was a pre-
dominance of major LEAs in individuals
without diabetes (minor-to-major ratio
for diabetes 1.4 [1.2–1.7] and for nondia-
betes 0.7 [0.6 0.8]).
Diabetes-related amputations
Between 2004 and 2008, the number of
patients who underwent an amputation
and the number of amputations per-
formed increased significantly among in-
dividuals with diabetes in England (Table
1). Overall amputation incidence rates
(minor and major combined) decreased
by 9.1%, from 27.5 per 10,000 people
with diabetes in 2004 to 25.0 per 10,000
people with diabetes in 2008. During the
study period, the incidence of minor
LEAs (15.7 to 14.9 per 10,000 people
with diabetes; P0.66) and major LEA
rates (11.8 to 10.2 per 10,000 people
with diabetes; P0.29) decreased
slightly, but this decrease did not reach
statistical significance (Fig. 1A). Inci-
dence of LEAs was significantly higher
among men than among women with di-
abetes (P0.001). However, changes in
overall LEA rates did not significantly dif-
fer between men and women (19.9 to
18.3 vs. 7.6 to 6.7 per 10,000 people with
diabetes; P0.81) (Fig. 2). When strat-
ified by age, the incidence was the highest
among individuals aged 65 years in
both men and women (Fig. 2). Poisson
regression analysis showed no significant
decrease in incidence of amputations after
adjustment for age, sex, year, and level of
amputation (0.98 decrease per year [95%
CI 0.93–1.02]; P0.12).
Nondiabetes-related amputations
The number of people without diabetes
who underwent a LEA and the number
of amputations performed decreased dur-
ing the study period. Although the per-
centage of men undergoing minor
amputations increased significantly, male
predominance was not evident among
minor amputees (Table 1). Amputation
incidence (minor and major combined)
decreased from 13.6 per 100,000 people
without diabetes in 2004 to 11.9 per
100,000 people without diabetes in 2008.
Incidence of minor LEAs decreased sig-
nificantly from 5.9 to 5.0 per 100,000
people without diabetes (P0.01).
There was a nonsignificant reduction in
the incidence of major LEAs among indi-
Vamos and Associates
care.diabetesjournals.org DIABETES CARE,VOLUME 33, NUMBER 12, DECEMBER 2010 2593
viduals without diabetes, from 7.7 to 6.9
per 100,000 people (P0.39) (Fig. 1B).
The fall in LEA rates was achieved be-
tween 2004 and 2006, and incidence
rates remained constant afterward for
both minor and major procedures. Inci-
dence of LEAs declined among both men
and women (Fig. 2). Of all decreases, 76%
have been achieved through a reduction
in LEAs in people aged 65 years (Fig. 2).
Poisson regression analysis showed that
the decline in nondiabetes-related LEAs
was marginally significant after adjust-
ment for age, sex, level of amputation,
and year (0.97 decrease by year [95% CI
0.93–1.00], P0.059).
Relative risk of amputations
The risk of an individual with diabetes
undergoing a LEA was 20.3 times that of
an individual without diabetes in 2004
and did not significantly change by 2008
(P0.317) (Table 2).
CONCLUSIONS — This nationwide
study was undertaken to quantify the in-
cidence and relative risk of nontraumatic
amputations in people with and without
diabetes between 2004 and 2008 in En-
gland. Our results indicate an increasing
number of procedures and a nonstatisti-
cally significant decline in the incidence
of amputations in people with diabetes.
Over the study period, the incidence of
diabetes-related amputations decreased
by 9.1%, from 27.5 to 25.0 per 10,000
people with diabetes. In contrast, the
number and incidence of LEAs decreased
in individuals without diabetes, and this
decline was marginally significant in a re-
gression model. As expected, we found a
markedly increased risk of amputations
in individuals with diabetes compared
with those without diabetes.
In recent years, a series of studies have
reported decreasing incidence of amputa-
tions from the U.S. and Western Europe
(6,7,10–12). Regional studies identified
large geographical variations in periph-
eral vascular disease and amputation in-
cidence. In England, the lowest diabetes-
related amputation rates were recorded in
centers in Leicester and Ipswich (11.0 and
16.0 per 10,000 people with diabetes, re-
spectively) and considerably higher inci-
dence was identified in Middlesbrough
(44.6 per 10, 000 people with diabetes)
(13,19). Wide variations in the incidence
of diabetes-related LEAs have been re-
ported across nationwide studies from
Western Europe. In Germany, incidence
was reported as 40.2 and 17.4 per 10,000
people with diabetes in men and women,
respectively and in the Netherlands as 36
per 10,000 people with diabetes (7,10).
Several factors have been described that
might explain these differences, such as
differences in study methodology, esti-
mation of the denominator, prevalence of
diabetes, case mix, availability of foot
clinics, diabetes specialists, treatment
programs and resources, the treatment
approach of an expert team, and demo-
graphic and clinical confounding factors,
among others (20). Canavan et al. (9)
identified prominently high major LEA
incidence (56.4 per 10,000 people with
diabetes) in the South Tees area, which
was attributed to the gaps in knowledge
and incomplete foot care in individuals
with diabetes. This rate decreased to 17.6
per 10,000 people with diabetes during a
5-year period as a result of better orga-
nized diabetes care. Schofield et al. (6)
found decreasing amputation rates in
Tayside, Scotland, and suggested that bet-
ter control for cardiovascular risk factors
might partly explain this reduction.
During the last decade, there have
been substantial improvements in quality
of diabetes management in U.K. primary
care in response to a wide range of initia-
tives such as national treatment standards
for the management of major chronic dis-
eases (5,21). Despite these developments,
this study found no evidence that the di-
abetes-related amputation incidence has
significantly decreased over the last 5
years. Risk factor intervention studies
have failed to demonstrate reduction in
peripheral arterial disease-related clinical
end points (22). It is possible that inter-
ventions to address the surrogate end
points measured and rewarded as part of
QOF have not been shown to translate
into reductions in clinical peripheral arte-
rial disease-related end points.
The relative risk of amputation in
Table 1—Characteristics of amputees between the financial years 2004–2005 and 2008–2009 in England
Diabetes-related LEAs
Pvalue
Nondiabetes-related LEAs
Pvalue2004–2005 2008–2009 2004–2005 2008–2009
Minor amputations
No. of amputations 2,768 3,289 2,266 1,966
Patient-to-amputation ratio 0.89 (0.88–0.91) 0.88 (0.86–0.90) 0.81 0.95 (0.94–0.97) 0.95 (0.93–0.97) 0.81
Sex, male 2,044 (73.8) 2,450 (74.5) 0.57 1,125 (49.6) 1,064 (54.1) 0.004
Age-group
16–44 years 167 (6.0) 204 (6.2) 0.85 198 (8.8) 152 (7.7) 0.42
45–64 years 1,045 (37.8) 1,248 (37.9) 524 (23.1) 481 (24.5)
65 years 1,556 (56.2) 1,837 (55.8) 1,544 (68.1) 1,333 (67.7)
Hospital length of stay (days) 15 (7–30) 13 (6–25) 0.001 5 (2–19) 6 (1–21) 0.41
Major amputations
No. of amputations 2,084 2,277 2,963 2,731
Patient-to-amputation ratio (95% CI) 0.88 (0.86–0.90) 0.88 (0.85–0.9) 0.98 0.95 (0.92–0.97) 0.94 (0.93–0.96) 0.81
Sex, male 1,465 (70.2) 1,640 (72.0) 0.21 1,860 (62.8) 1,699 (62.2) 0.68
Age-group
16–44 years 73 (3.5) 83 (3.6) 0.48 222 (7.5) 247 (9.0) 0.48
45–64 years 628 (30.1) 663 (29.1) 654 (22.1) 614 (22.5)
65 years 1,383 (66.4) 1,531 (67.2) 2,087 (70.4) 1,870 (68.5)
Hospital length of stay (days) 38 (22–69) 34 (20–59) 0.001 32 (17–58) 28 (15–52) 0.001
Data are ratio (95% CI), n(%), or median (interquartile range).
Lower extremity amputation trends in England
2594 DIABETES CARE,VOLUME 33, NUMBER 12, DECEMBER 2010 care.diabetesjournals.org
people with diabetes compared with
those without diabetes did not signifi-
cantly change over the study period in
England (20.5 in 2004 and 21.2 in 2008).
Previous reports from small geographic
areas showed large variations in relative
risk of amputations in England (from 7.7
to 31.6) (9,19). Nationwide studies from
other Western European countries also
reported varying relative risk of LEAs
(20.3 in the Netherlands and 7.4 in Ger-
many) (10,23).
When calculating diabetes-specific
incidence rates, we used the total number
of people with diabetes in England as de-
nominator, based on data from QMAS
(5). During the study period, the preva-
lence of diabetes increased from 4.4 to
5.2% in people aged 17 years in En-
gland (5,17). The modest reduction in di-
abetes-related amputation incidence
occurred between 2004 and 2006, and
LEA rates remained fairly constant after-
ward. A clear explanation for this finding
is lacking because the rise in the denom-
inator was steady over the study period;
therefore, it is not likely to explain this
trend. Furthermore, a similar pattern was
found in people without diabetes. It is
possible that an increased number of sub-
jects with shorter diabetes duration and
without complications in the diabetic
population might explain this finding (6).
To the best of our knowledge, this is
the first study to identify diabetes-related
amputation incidence using a national
sample that covers the entire population
of England. Previous reports have mostly
documented center-oriented or regional
information (8,9,13,19). The results of
these studies may not be generalizable be-
cause these centers might be highly spe-
cialized in diabetic foot care and have a
relatively small number of amputations.
Furthermore, the calculation of denomi-
nators may be flawed because of the po-
tential overlap between the catchment
areas of different institutions and patient
referrals from or to other centers. In con-
trast, denominator data for our survey
were derived from a comprehensive na-
tional database. These estimates are likely
to be robust, given that an estimated 99%
of the U.K. population are registered with
a family practitioner and nearly 100% of
practices participate in the pay for perfor-
mance scheme that incentivizes com-
pleteness of disease registers (5).
We were able to distinguish individ-
ual patients and therefore multiple hospi-
talizations using information on date of
birth, sex, and full postcode. Information
on laterality of amputations was also
available in this study with very high
completeness, enabling identification of
LEAs on different limbs during the same
admission, and these procedures could be
counted separately. Furthermore, we ex-
amined both minor and major amputations
and reported LEA incidence separately by
level of procedure and also included a non-
diabetes comparator (11,24).
Limitations have to be considered in
interpretation of our results. Because of
the lack of accurate data on the age- and
sex-specific prevalence of diabetes, we
used the stratum-specific prevalence data
from 2006, the mid-term of our study pe-
riod and had to assume that this informa-
tion remained constant between 2004
and 2008 (3). The increase in prevalence
of diabetes during the study period might
be partly explained by better ascertain-
ment and recording of diabetes after the
implementation of pay for performance in
2004. However, the increase was consis-
tent during the study period and most of
the improved ascertainment is likely to
have occurred immediately before the
study period as practices responded to the
incentives in QOF. We did not distin-
guish between type 1 and type 2 diabetes
because separate data on national preva-
lence of different types were not available.
Furthermore, we could not evaluate mis-
classification due to undiagnosed and un-
recorded cases of diabetes.
Although concerns about the accu-
racy of routinely collected datasets has
been raised, these data are continuously
Figure 1—Changes in minor and major amputation incidence rates in (A) individuals with
diabetes expressed per 10,000 people with diabetes and (B) individuals without diabetes expressed
per 100,000 people without diabetes.
Vamos and Associates
care.diabetesjournals.org DIABETES CARE,VOLUME 33, NUMBER 12, DECEMBER 2010 2595
audited and the quality and validity of this
dataset has been assessed and proved use-
ful for health research (25).
In summary, in this study we found
no evidence that the incidence of ampu-
tations has significantly decreased over
the last 5 years among people with diabe-
tes in England. In contrast to the results
from regional studies in England, the
population burden of amputations in-
creased in people with diabetes at a time
when both the number and incidence of
amputations decreased in the aging gen-
eral population. There is strong evidence
to support the fact that much of this bur-
den is preventable through existing inter-
ventions, and our findings highlight the
need to further improve foot care for peo-
ple with diabetes.
Acknowledgments The research leading
to these results has received funding from the
European Community Seventh Framework
Programme FP7/2007-11 under grant agree-
ment 236336. A.B. and the Dr Foster Unit at
Imperial College London are largely funded by
Dr Foster Intelligence, an independent health
care information company. C.M. is funded by
the Higher Education Funding Council for En-
gland and the National Institute for Health Re-
search. The Department of Primary Care and
Public Health at Imperial College London ac-
knowledges support from the National Insti-
tute for Health Research Biomedical Research
Centre Scheme and the National Institute for
Health Research Collaboration for Leadership
in Applied Health Research and Care Scheme.
No potential conflicts of interest relevant to
this article were reported.
E.P.V. conceived the idea for the study, re-
searched data, and wrote the manuscript. A.B.
researched data and reviewed/edited the
manuscript. M.E.E., J.V., and A.M. contrib-
uted to discussion and reviewed/edited manu-
script. C.M. conceived the idea for the study
and wrote the manuscript.
Parts of this study were presented in ab-
stract form at the 46th annual meeting of the
European Association for the Study of Diabe-
tes, Stockholm, Sweden, 20–24 September
2010.
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Figure 2—Changes in amputation incidence rates between 2004–2005 and 2008–2009 in En-
gland in (A) individuals with diabetes expressed per 10,000 people with diabetes and (B) individ-
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Table 2—Relative risk of LEAs in individuals with diabetes compared with those without
diabetes between 2004–2005 and 2008–2009 in England
Minor amputations Major amputations All amputations
2004–2005 27.0 (25.5–28.5) 15.5 (14.7–16.4) 20.5 (19.7–21.3)
2005–2006 29.3 (27.7–31.0) 14.6 (13.8–15.5) 20.7 (19.9–21.6)
2006–2007 30.2 (28.5–31.9) 14.2 (13.4–15.1) 20.9 (20.1–21.8)
2007–2008 30.4 (28.7–32.2) 14.4 (13.6–15.2) 21.0 (20.2–21.8)
2008–2009 29.9 (28.3–31.7) 14.9 (14.1–15.7) 21.2 (20.4–22.1)
Data are relative risk (95% CI). P0.001 for all.
Lower extremity amputation trends in England
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Vamos and Associates
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... For example, the Vascular Society for Great Britain and Ireland produced guidelines for a best practice pathway while the UK All-Party Parliamentary Group on Vascular and Venous Disease issued a call for action to reduce inequalities in major amputation rates 10,11 . While a number of studies have reported on major lower limb amputation rates in England [4][5][6][7][8][12][13][14] , including some that have examined trends over time 4,6,8,12 , few have examined trends over time in mortality following amputation 8 . Major lower limb amputation is typically performed as above knee amputation (AKA) or below knee amputation (BKA). ...
... For example, the Vascular Society for Great Britain and Ireland produced guidelines for a best practice pathway while the UK All-Party Parliamentary Group on Vascular and Venous Disease issued a call for action to reduce inequalities in major amputation rates 10,11 . While a number of studies have reported on major lower limb amputation rates in England [4][5][6][7][8][12][13][14] , including some that have examined trends over time 4,6,8,12 , few have examined trends over time in mortality following amputation 8 . Major lower limb amputation is typically performed as above knee amputation (AKA) or below knee amputation (BKA). ...
... Ahmad et al. found an age-adjusted rate ratio of approximately 7 6 . Vamos et al. found an unadjusted rate ratio of approximately 15 4 . The equivalent unadjusted rate ratio from the present study was 8.86. ...
Article
Full-text available
Background Above and below knee amputation (AKA, BKA) are treatments of last resort for peripheral arterial disease (PAD). The aim was to examine amputation rates, AKA:BKA ratios, previous revascularization and minor amputation, lengths of stay in hospital, mortality following amputation, and regional variation in people with and without diabetes in England. Methods The study used population-based ecological and cohort study designs, 31 672 census areas, hospital admissions from 2006 to 2018 and Poisson, logistic and Cox regression. Results There were 47 249 major lower limb amputations (50.7% AKA; 48% had diabetes), giving an annual PAD-related amputation rate of 11 per 100 000 in the population aged 25+ years. Amputation rates were higher in men and substantially higher in people with diabetes. The AKA:BKA ratio was 0.63 in patients with diabetes (n = 22 702) and 1.62 in patients without diabetes (n = 24 547). Of patients having AKA, 25.3% died within 90 days of amputation compared with 11.9% for BKA. Median survival following amputation ranged from only 1.68 years following AKA in patients with diabetes to 5.72 years following BKA in patients without diabetes. Amputation rates decreased over time mainly in the population with diabetes. Short-term mortality and lengths of stay in hospital also decreased over time, while the percentage with previous revascularization generally increased. Amputation rates and AKA:BKA ratios were highest in the North. Adjustment for age, sex and deprivation did not substantially alter geographical patterns. Adjusted 90-day mortality was generally higher in the North and the Midlands but also high in London. There were also regional variations in adjusted duration from admission to amputation, duration from amputation to discharge or death in hospital, previous revascularization and previous minor amputation. Conclusions There were large variations in amputation rates and survival following amputation in relation to diabetes status and amputation level, and regional variations which remained after adjustment for deprivation.
... LEAs were categorized as major and minor amputations according to procedure codes. A major lower extremity amputation was defined as the surgical removal of a part or whole limb proximal to the ankle joint [15]. ...
... per 1000 people year, while the incidence in the control group of people without diabetes was 0.08 (0.08-0.09) per 1000 people/year [37]. A similar trend was reported in the UK in a study conducted between 2000 and 2008 [15] and in Canada from findings reported between 2012 and 2016 [38]. ...
Article
Full-text available
Background and Objectives: The primary objective of this study was to investigate the incidence of lower extremity amputations (LEAs) in a representative population from Romania, in both diabetic and non-diabetic adults, including trauma-related amputations. The secondary objective was to evaluate the trends in LEAs and the overall ratio of major-to-minor amputations. Material and Methods: The study was retrospective and included data from the Romanian National Hospital Discharge Records, conducted between 1 January 2015 and 31 December 2019. Results: The overall number of cases with LEAs was 88,102, out of which 38,590 were aterosclerosis-related LEAs, 40,499 were diabetes-related LEAs, and 9013 were trauma-related LEAs, with an ascending trend observed annually for each of these categories. Of the total non-traumatic amputations, 51.2% were in patients with diabetes. Most LEAs were in men. The total incidence increased from 80.61/100,000 in 2015 to 98.15/100,000 in 2019. Conclusions: Our study reported a 21% increase in total LEAs, 22.01% in non-traumatic LEAs, and 19.65% in trauma-related amputation. The minor-to-major amputation ratio increased over the study period in patients with diabetes. According to these findings, it is estimated that currently, in Romania, there is one diabetes-related amputation every hour and one non-traumatic amputation every 30 min.
... In Australia, analysis of data from the Western Australian Data Linkage System for the period from 2000 to 2010 revealed decreases in the rate of major and minor amputations of 6.2% and 0.6% per year, respectively [26]. In England, data from the National Health Service comprising all patients with non-traumatic amputations in the period from 2004 to 2008 showed that the incidence of LEA-DFD did not significantly change (from 27.5 to 25.0 per 10.000 subjects with diabetes) [27]. During the same period, in Ireland, total diabetes-related amputation rates increased non-significantly during the study period (144.2 in 2005 to 175.7 in 2009 per 100,000 people with diabetes) [28]. ...
Article
Full-text available
Background: One of the most devastating complications of diabetes is diabetes-related foot disease (DFD), which is a priority for public health systems. The 2016-2020 Catalonia Health Plan aimed to reduce the incidence of total and major lower-extremity amputations (LEAs) due to DFD by 10% in the population aged 45-74 years. The aim of the present study was to compare the incidence of LEA-DFD 5 years before and after the creation of the Diabetic Foot Multidisciplinary Unit at our Hospital. Methods: We prospectively collected all cases of LEA-DFD performed at Vall d'Hebron University Hospital from 1 January 2016 to 31 December 2020. Cases of LEA-DFD performed from 1 January 2011 to 31 December 2015 were retrospectively reviewed. The incidence of LEA-DFD between these periods was compared. Results: A total of 457 LEAs due to DFD were performed in 316 patients. We observed a reduction of 27.9% [CI: 23.7-32.1%] in the incidence of total LEA in the 2016-2020 period in comparison with the period 2011-2016 (0.8 ± 0.1 vs. 1.1 ± 0.3 per 10.000 inhabitants/year, p < 0.001), as well as a reduction of 49.3% [CI: 44.6-53.9%] in the incidence of major LEA-DFD (0.15 ± 0.1 vs. 0.30 ± 0.1 per 10.000 inhabitants/year, p < 0.001). Conclusions: The implementation of a Diabetic Foot Multidisciplinary Unit resulted in a significant reduction in the rate of amputations due to DFD in the population with diabetes in North Barcelona.
... The surgical amputation of a lower limb leads to a highly disabling condition for the patient. An amputation may be necessary because of several reasons, among which the most common are diabetes, cardiovascular diseases, and on-the-job injuries [1,2]. Despite the efforts aimed at reducing the risk of amputation, the development of comfortable, reliable and custom-made lower limb prostheses represents a crucial aspect which needs to be thoroughly taken into account, by properly understanding and describing the biomechanical interaction between the prosthesis and the patient's limb, in order to improve the quality of life of the amputees. ...
Chapter
The development of comfortable, reliable and custom-made lower limb prostheses represents a crucial aspect, in order to improve the quality of life of amputees. In this context, the aim of this work is to study the donning phase of a custom-made prosthetic socket for transfemoral amputees, by means of numerical simulations.Finite Element Analyses (FEA) were performed to study contact pressures and stresses developed on the stump during the donning. Proper materials models and the presence of the friction and the liner were introduced, in order to analyze their impact on simulations results. Then, a sensitivity analysis to assess the influence of the stiffness of the liner was conducted.The proposed model was able to capture a comprehensive state of stress on the stump at the end of the donning phase. The beneficial effects linked to the introduction of the liner are properly described, too: this element is able to redistribute the stresses which are transmitted to the stump, thus obtaining a more homogenous state of stress. Finally, the sensitivity analysis showed that the variable stiffness of the liner mainly affects the maximum strains on the stump, whereas its influence on the maximum values of contact pressure seems to be limited.KeywordsFEAprosthetic socketlinertransfemoral amputees
... In our patients, Table II type I DM was present in 42 patients and type II DM was present in 170 patients. This is in agreement with the finding of Vamos et al [5] . Diabetic foot ulcers occur as a result of various factors, such as mechanical changes in conformation of the bony architecture of the foot, peripheral neuropathy, and atherosclerotic peripheral arterial disease, all of which occur with higher frequency and intensity in the diabetic population. ...
Chapter
Passive shoulder exoskeletons are increasingly used as assistive devices to reduce the physical demands on the shoulder region during work-related tasks. This study evaluates the effects of the Exo4Work exoskeleton on musculoskeletal loading during working activities in real-life conditions in the workplace. Inertial measurement units and electromyography were used to analyze the effects of the Exo4Work exoskeleton in 5 workers executing their routine occupational tasks in the workplace. The IMU-based kinematics were then used as input for a musculoskeletal modeling workflow to investigate muscle force distribution. Despite system usability scores comparable to previously investigated exoskeletons, there was no effect of the exoskeleton on musculoskeletal loading. Furthermore, shoulder muscle EMG activity was not consistently reduced in all 5 participants. This is the first study investigating the effect of a passive shoulder exoskeleton on full-body musculoskeletal loading in the workplace using a musculoskeletal modeling approach based on joint kinematics estimated by inertial measurement units. The exoskeleton did not affect musculoskeletal loading in the workplace. These findings contradict the reductions in musculoskeletal loading observed in the laboratory with the Exo4Work shoulder exoskeleton reported by our group.KeywordsPassive shoulder exoskeletonfull-body musculoskeletal modelingin-field evaluationInertial measurement units
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Rehabilitation is usually provided to patients with chronic foot wounds (CFWs) after surgery. This study aimed to assess whether early postoperative rehabilitation could maintain walking independence in hospitalized patients with CFWs. This single-blind, randomized clinical trial was performed between September 10, 2018 and March 2019, involving 60 patients who underwent both surgical procedures and rehabilitation. Participants were randomly allocated into the early rehabilitation (EG, n = 30) or the control (CG, n = 30) groups. EG received early rehabilitation immediately after surgery, while CG received late rehabilitation after wound closure. Both groups received rehabilitation sessions 5 times per week until discharge. The primary outcome was walking independence, measured via Functional Independence Measure (FIM)-gait scores. Secondary outcomes included health-related quality of life (HRQoL) using EuroQol 5 dimensions 5-level (EQ-5D-5L) and the presence of rehabilitation-related adverse events, including dehiscence of wounds and falls. Differences in intervention timing effects were analyzed using nonparametric split-plot factorial design analysis, including Fisher's exact test, Mann-Whitney U test, and Wilcoxon signed-rank test (P < .05). Out of the 60 participants, 53 patients completed the discharge follow up. Three participants (10.0%) from the EG and 4 (13.3%) from the CG dropped out due to postoperative complications unrelated to rehabilitation intervention. No rehabilitation-related adverse events were found. Participants in the EG maintained greater FIM-gait scores during hospitalization than the CG (difference, -1; P = .0001), with a difference of 0 (P = .109) at discharge. EQ-5D-5L significantly improved in both groups (EG: difference, 0.13 [P = .014], CG: difference, 0.17 [P = .0074]). The EG intervention was associated more with maintaining walking independence at discharge than CG intervention. Postoperative rehabilitation improved HRQoL without adverse events, indicating that clinicians should recommend early rehabilitation for patients with CFW to enhance walking independence.
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Background: Type 2 diabetes mellitus (T2DM) is a rising global health concern that requires long-term treatment and close monitoring. Telemonitoring has been shown to be a promising tool to facilitate patient-physician interaction and improve glycaemic control. Method: Randomised controlled trials (RCT) of telemonitoring in T2DM published between 1990 and 2021 were searched through multiple electronic databases. The primary outcome variables included HbA1c and fasting blood glucose (FBG), and BMI was a secondary outcome variable. Results: Thirty RCT with a total of 4,678 participants were included in this study. Twenty-six studies reported on HbA1c, which was shown to be significantly lower in participants on telemonitoring when compared to conventional care. Ten studies investigated FBG which collectively showed no statistically significant difference. Subgroup analysis demonstrated the effect of telemonitoring on glycaemic control is influenced by a range of factors concerning system practicality, user engagement, patient characteristics and disease education. Conclusion: Telemonitoring exhibited a great potential to improve T2DM management. Several technical features and patient factors may influence the effectiveness of telemonitoring. Further studies are needed to verify the findings and address limitations before its implementation into routine practice.
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Lower limb amputation (LLA) is a major surgical procedure with a significant impact on quality of life and mortality rates as well. Previous studies have shown that mortality rates following LLA can range from 9-17% within 30 days in the UK. This study systematically evaluates and reviews the published literature on life expectancy, mortality, and survival rates following lower extremity amputation (LEA). We have conducted a comprehensive search on Medline, CINAHL, and Cochrane Central databases resulting in 87 full-text articles. After a thorough review, only 45 (52.9%) articles met the minimum inclusion criteria for the study. Our analysis indicated 30-day mortality rates following LEA ranged from 7.1% to 51.4%, with an average mortality rate of 16.45% (SD 14.35) per study. Furthermore, 30-day mortality rates following below-knee amputation (BKA) and above-knee amputation (AKA) were found to be between 6.2% to 51.4%, X= 17.16% ± 19.46 SD and 12.7 to 21.7%, X= 16.15% ± 4.17 SD, respectively. Our review provides a comprehensive insight into the life expectancy, mortality, and survival rates following LEA. These findings highlight the importance of considering various factors, including patient age, presence of comorbidities such as diabetes, heart failure, and renal failure, and lifestyle factors such as smoking, in determining prognosis following LLA. Further research is necessary to determine strategies for improving outcomes and reducing mortality in this patient population.
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Background Improved blood-glucose control decreases the progression of diabetic microvascular disease, but the effect on macrovascular complications is unknown. There is concern that sulphonylureas may increase cardiovascular mortality in patients with type 2 diabetes and that high insulin concentrations may enhance atheroma formation. We compared the effects of intensive blood-glucose control with either sulphonylurea or insulin and conventional treatment on the risk of microvascular and macrovascular complications in patients with type 2 diabetes in a randomised controlled trial. Methods 3867 newly diagnosed patients with type 2 diabetes, median age 54 years (IQR 48-60 years), who after 3 months' diet treatment had a mean of two fasting plasma glucose (FPG) concentrations of 6.1-15.0 mmol/L were randomly assigned intensive policy with a sulphonylurea (chlorpropamide, glibenclamide, or. glipizide) or with insulin, or conventional policy with diet. The aim in the intensive group was FPG less than 6 mmol/L. in the conventional group, the aim was the best achievable FPG with diet atone; drugs were added only if there were hyperglycaemic symptoms or FPG greater than 15 mmol/L. Three aggregate endpoints were used to assess differences between conventional and intensive treatment: any diabetes-related endpoint (sudden death, death from hyperglycaemia or hypoglycaemia, fatal or non-fatal myocardial infarction, angina, heart failure, stroke, renal failure, amputation [of at least one digit], vitreous haemorrhage, retinopathy requiring photocoagulation, blindness in one eye,or cataract extraction); diabetes-related death (death from myocardial infarction, stroke, peripheral vascular disease, renal disease, hyperglycaemia or hypoglycaemia, and sudden death); all-cause mortality. Single clinical endpoints and surrogate subclinical endpoints were also assessed. All analyses were by intention to treat and frequency of hypoglycaemia was also analysed by actual therapy. Findings Over 10 years, haemoglobin A(1c) (HbA(1c)) was 7.0% (6.2-8.2) in the intensive group compared with 7.9% (6.9-8.8) in the conventional group-an 11% reduction. There was no difference in HbA(1c) among agents in the intensive group. Compared with the conventional group, the risk in the intensive group was 12% lower (95% CI 1-21, p=0.029) for any diabetes-related endpoint; 10% lower (-11 to 27, p=0.34) for any diabetes-related death; and 6% lower (-10 to 20, p=0.44) for all-cause mortality. Most of the risk reduction in the any diabetes-related aggregate endpoint was due to a 25% risk reduction (7-40, p=0.0099) in microvascular endpoints, including the need for retinal photocoagulation. There was no difference for any of the three aggregate endpoints the three intensive agents (chlorpropamide, glibenclamide, or insulin). Patients in the intensive group had more hypoglycaemic episodes than those in the conventional group on both types of analysis (both p<0.0001). The rates of major hypoglycaemic episodes per year were 0.7% with conventional treatment, 1.0% with chlorpropamide, 1.4% with glibenclamide, and 1.8% with insulin. Weight gain was significantly higher in the intensive group (mean 2.9 kg) than in the conventional group (p<0.001), and patients assigned insulin had a greater gain in weight (4.0 kg) than those assigned chlorpropamide (2.6 kg) or glibenclamide (1.7 kg). Interpretation Intensive blood-glucose control by either sulphonylureas or insulin substantially decreases the risk of microvascular complications, but not macrovascular disease, in patients with type 2 diabetes. None of the individual drugs had an adverse effect on cardiovascular outcomes. All intensive treatment increased the risk of hypoglycaemia.
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To examine secular trends in diabetes-related preventable hospitalizations among adults with diabetes in the U.S. from 1998 to 2006. We used nationally representative data from the National Inpatient Sample to identify diabetes-related preventable hospitalizations. Based on the Agency for Healthcare Research and Quality's Prevention Quality Indicators, we considered that hospitalizations associated with the following four conditions were preventable: uncontrolled diabetes, short-term complications, long-term complications, and lower-extremity amputations. Estimates of the number of adults with diabetes were obtained from the National Health Interview Survey. Rates of hospitalizations among adults with diabetes were derived and tested for trends. Age-adjusted rates for overall diabetes-related preventable hospitalizations per 100 adults with diabetes declined 27%, from 5.2 to 3.8 during 1998-2006 (P(trend) < 0.01). This rate decreased significantly for all but not for short-term complication (58% for uncontrolled diabetes, 37% for lower-extremity amputations, 23% for long-term complications [all P < 0.01], and 15% for the short-term complication [P = 0.18]). Stratified by age-group and condition, the decline was significant for all age-condition groups (all P < 0.05) except short-term complications (P = 0.33) and long-term complications (P = 0.08) for the age-group 18-44 years. The decrease was significant for all sex-condition combination subgroups (all P < 0.01). We found a decrease in diabetes-related preventable hospitalizations in the U.S. from 1998 to 2006. This trend could reflect improvements in quality of primary care for individuals with diabetes.
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Alternative formulations of Levene's test statistic for equality of variances are found to be robust under nonnormality. These statistics use more robust estimators of central location in place of the mean. They are compared with the unmodified Levene's statistic, a jackknife procedure, and a χ2 test suggested by Layard which are all found to be less robust under nonnormality.
Article
To examine trends in non-traumatic lower extremity amputations over a 10-year-period in people with and without diabetes (DM) in England. All individuals admitted to NHS hospitals for non-traumatic amputations between 1996 and 2005 in England were identified using hospital activity data. Postoperative and 1-year mortality were examined between 2000 and 2004. There was a reduction in minor and major amputations during the study period. The number of type 1 DM- and non-DM-related minor amputations decreased by 11.4% and 32.4%, respectively, while the number of type 2 DM-related minor amputations almost doubled. The incidence of type 1- and non-DM-related minor amputations decreased from 1.5 to 1.2 and from 8.1 to 5.1/100,000 population, respectively, while type 2 DM-related amputations increased from 2.4 to 4.1/100,000 population. The number of type 1- and non-DM-related major amputations declined by 41% and 22%, respectively, whereas type 2 DM-related amputations increased by 43%. The incidence of type 2 DM-related amputations increased from 2.0 to 2.7/100,000 population. Overall perioperative and 1-year mortality did not significantly change between 2000 and 2004. While several factors may explain the increase in type 2 DM-related LEAs, these findings highlight the importance of diabetes prevention strategies and controlling risk factors for LEAs in people with diabetes.
Article
To assess the changing rate of amputation in patients with diabetes over a 7-year period. All patients undergoing lower extremity amputation in Tayside, Scotland between 1 January 2000 and 31 December 2006 were identified. Temporal linkage of cases to the diabetes database was used to ascertain which amputations were in patients with diabetes. The incidence of major amputations fell from 5.1 [95% confidence interval (CI) 3.8-6.4] to 2.9 (95% CI 1.9-3.8) per 1000 patients with diabetes (P < 0.05). There is a clear linear trend in the adjusted incidence of major amputation (P = 0.023 and 0.027 for age- and sex-adjusted, and duration- and sex-adjusted incidences, respectively). The adjusted incidence of total amputations followed decreased linear regression trend over the whole study period when adjusted for age and sex or diabetes duration and sex (P = 0.002). There has been a significant reduction in the incidence of major lower extremity amputation in patients with diabetes over the 7-year period.
Article
One major objective is to reduce the risk of lower limb amputation in diabetes mellitus. Nationwide data to incidences of amputations in the diabetic and non-diabetic populations in Germany as well as relative and attributable risks due to diabetes are lacking so far. Using data of a nationwide statutory health insurance (1.6 million members), we assessed all first non-traumatic lower-limb amputations between 2005 and 2007. We estimated sex-age-specific and standardized incidences of amputations in the diabetic and non-diabetic populations, and relative and attributable risks due to diabetes. Of all subjects with a first amputation in the study period 2005-2007 (n=994), 66% had diabetes, 76% were male, mean age (SD) was 67 (13) years. Incidences per 100 000 person years (standardized to the 2004 German population) in the diabetic and the non-diabetic populations: 176.5 (95% confidence interval 156.0-196.9) and 20.0 (17.0-23.1) in men, and 76.9 (61.9-91.8) and 13.4 (10.7-16.2) in women. Standardized relative risks: 8.8 (7.3-10.7) in men and 5.7 (4.3-7.6) in women. Attributable risks among exposed: 0.89 and 0.83 and population attributable risks 0.59 and 0.40, each in men and women, respectively. In our first German nationwide study, we found the relative risk of lower limb amputation in the diabetic compared to the non-diabetic to be lower than in earlier regional studies in Germany, supporting results of regional reductions of the excess amputation risk due to diabetes. A repetition of the study is warranted to further evaluate trends according to the St. Vincent goals.
Article
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. 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. We estimated 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 less than 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 less than 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. 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.