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OBES SURG (2009) 19:184189

DOI 10.1007/s11695-008-9534-7


Change in Predicted 10-Year Cardiovascular Risk Following

Laparoscopic Roux-en-Y Gastric Bypass Surgery
David Arterburn & Daniel P. Schauer & Ruth E. Wise &
Keith S. Gersin & David R. Fischer &
Calvin A. Selwyn Jr & Anne Erisman & Joel Tsevat

Received: 31 March 2008 / Accepted: 7 April 2008 / Published online: 13 August 2008
# Springer Science + Business Media, LLC 2008

Background Bariatric surgery is being conducted more
often for morbid obesity, but little evidence exists about
how it affects the risk of future cardiovascular events. The
goal of this study was to quantify the change in predicted
10-year cardiovascular risk following laparoscopic Rouxen-Y gastric bypass (LRYGBP).
Methods We conducted a prospective clinical study of
morbidly obese adults undergoing LRYGBP at a university

D. Arterburn (*)
Group Health Center for Health Studies,
1730 Minor Ave, Suite 1600,
Seattle, WA 98101, USA
e-mail: arterburn.d@ghc.org
D. Arterburn
Department of Medicine, University of Washington,
Seattle, WA, USA
D. P. Schauer : R. E. Wise : J. Tsevat
Department of Medicine, University of Cincinnati,
Cincinnati, OH, USA
K. S. Gersin
General Surgery, Carolinas Medical Center,
Charlotte, NC, USA
D. R. Fischer : A. Erisman
Department of Surgery, University of Cincinnati,
Cincinnati, OH, USA
C. A. Selwyn Jr
General Surgery, Ministry Medical Group,
Stevens Point, WI, USA
J. Tsevat
Cincinnati Veterans Affairs Medical Center,
Cincinnati, OH, USA

hospital in the USA. Our primary outcome measure was

mean change in 10-year cardiovascular risk at 12 months.
We estimated cardiovascular risk by using the Framingham
risk equation, which calculates the absolute risk of
cardiovascular events for patients with no known history
of heart disease, stroke, or peripheral vascular disease by
using information on age, sex, blood pressure, total and
high-density lipoprotein cholesterol levels, smoking status,
and history of diabetes.
Results Ninety-two participants underwent LRYGBP between December 2004 and October 2005. Their predicted
baseline 10-year cardiovascular risk was 6.7%. At 6 and
12 months, their predicted risk had decreased to 5.2% and
5.4%, respectively. Assuming no change in risk among
untreated patients, this represents an absolute risk reduction
of 1.3%; which suggests that 77 morbidly obese patients
would have to undergo LRYGBP to avert one new case of
cardiovascular disease over the ensuing 10 years (number
needed to treat=77).
Conclusion Our findings indicate that LRYGBP is associated with improvements in cardiovascular risk factors and a
corresponding decrease in predicted 10-year risk of cardiovascular disease.
Keywords Morbid obesity . Cardiovascular diseases .
Risk factors . Diabetes mellitus . Hypertension .
Hyperlipidemia . Gastric bypass

The prevalence of morbid obesity [defined as a body mass
index (BMI) 40 kg/m2] has increased rapidly in the USA,
from 0.8% in 19601962 to 4.8% in 20032004 [1, 2].

OBES SURG (2009) 19:184189

Morbid obesity is associated with a substantially greater

risk of morbidity and mortality from chronic health
conditions, such as diabetes, hypertension, cardiovascular
disease, and cancer [3, 4]; it has been linked to multidimensional impairments in health-related quality of life and
psychosocial well-being [5]. The economic burden of
morbid obesity among US adults is also substantial:
Healthcare expenditures for morbidly obese adults are
81% greater than for normal-weight adults [6]. In 2000,
aggregate US healthcare expenditures associated with
excess body weight among morbidly obese adults exceeded
$11 billion [6].
The health and economic impacts of morbid obesity
underscore the urgent need to identify effective treatments.
Unfortunately, dietary, behavioral, and drug treatment
options frequently fail to result in sustained, clinically
meaningful weight loss in patients with morbid obesity [7].
On the other hand, a growing body of evidence demonstrates that bariatric surgery can promote sustained weight
loss and improvements in diabetes and other cardiovascular
risk factors [8, 9]. Less evidence suggests that bariatric
surgery can reduce the risk of future cardiovascular events
An individuals probability of developing cardiovascular
disease over the next 10 years can be estimated by
calculating a Framingham risk score, which uses information on age, sex, blood pressure, current smoking status,
presence or absence of diabetes, and levels of total and
high-density lipoprotein (HDL) cholesterol to summarize
the combined 10-year risk of angina pectoris, myocardial
infarction, unstable angina, and cardiovascular death [13].
The Framingham risk equations were developed in a large
prospective cohort of US men and women age 3074 years;
the equations have been validated in multiple diverse
populations and discriminate well among those who will
have a cardiovascular event and those who will not [14].
The goal of this study was to quantify the change in
predicted 10-year cardiovascular risk following laparoscopic Roux-en-Y gastric bypass (LRYGBP) among adults with
morbid obesity.

Materials and Methods

We conducted a prospective clinical study of 100 morbidly
obese adults undergoing LRYGBP at the University of
Cincinnatis Center for Surgical Weight Loss between
December 2004 and November 2006. Data analyses were
completed at Group Health in Seattle, WA, USA. The
institutional review boards of the University of Cincinnati
and Group Health reviewed and approved all study


Study Population
Based on 1998 National Institutes of Health guidelines,
patients eligible for LRYGBP had either a BMI40 kg/m2,
or a BMI35 kg/m2 and one or more obesity-associated
chronic medical condition(s) that had not improved with
previous behavioral and/or drug treatments for weight loss.
All the patients received comprehensive preoperative
dietary and behavioral counseling. The patients also
underwent a preoperative evaluation by an internist and
psychologist. The patients who completed those evaluations
and demonstrated a clear understanding of the extensive
dietary, exercise, and medical implications of weight loss
surgery were considered eligible for the procedure.
Data Collection Procedures
In accordance with Health Insurance Portability and
Accountability Act regulations, we asked consecutive
morbidly obese patients scheduled for LRYGBP to participate in this study and obtained written informed consent
from all participants. Study participants had the following
clinical and laboratory assessments performed at baseline
(preoperative), 6 months, and 12 months after surgery:
body weight, blood pressure, and levels of hemoglobin A1c
(HbA1c), fasting blood sugar, and fasting serum cholesterol
[triglycerides and total, HDL, and low-density lipoprotein
(LDL) cholesterol]. A trained research nurse specialist
extracted these clinical and laboratory data from paper
and electronic medical record databases and extracted
information on length of hospital stay and operative and
postoperative complications.
The primary outcome measure in this study was mean
change in 10-year cardiovascular risk. This risk was
estimated at baseline, 6 months, and 12 months using the
Framingham risk equation [13]. This equation calculates
the absolute risk of coronary heart disease (CHD) events for
patients with no known history of CHD, stroke, or
peripheral vascular disease, based on patients age, sex,
blood pressure, total and HDL cholesterol levels, smoking
status, and history of diabetes [13, 14]. Secondary outcomes included body weight, BMI, systolic and diastolic
blood pressure, fasting serum cholesterol levels, fasting
glucose level, and HbA1c level.
Statistical Analyses
We examined mean 12-month changes in our secondary
outcomes using the paired t test. The effect of LRYGBP on
10-year cardiovascular risk was examined as the mean
difference in percentage risk over 12 months by using the
paired t test. Based on the published literature regarding


OBES SURG (2009) 19:184189

changes in cardiovascular risk factors following bariatric

surgery, we expected to observe a mean reduction in 10year cardiovascular risk from 7 to 3% over 1-year followup [1519]. We estimated that a sample of 100 patients
would result in more than 99% power to detect a 4%
change in 10-year cardiovascular over 1-year follow-up
(given an alpha of 0.05). P values <0.05 were considered
statistically significant. All analyses were conducted using
STATA 9.0 (College Station, TX, USA).
Missing data in weight loss studies are unlikely to be
missing at random because dropout may be related to
efficacy of treatment; thus, estimated treatment effects from
a completers-only analysis will be biased [20]. The
baseline-observation carried forward (BOCF) method has
been proposed as a simple solution to this problem [21].
This conservative approach assumes that all dropouts return
to their baseline weight at endpoint, regardless of the
duration of follow-up and last recorded weight. For our
primary and secondary outcomes, we report our analyses
using BOCF and completers only to examine the effect of
our missing data at 6 and 12 months.

We enrolled 100 participants who underwent LRYGBP
between December 2004 and October 2005. One patient
died from respiratory failure following aspiration. Two
cases were aborted intraoperatively: one due to the
discovery of gastric cancer and the other due to excessive
bleeding due to a coagulopathy. Five patients returned to
the operating room during their initial hospitalization for
laparoscopy or revision. The mean hospital length of stay
following surgery was 3.2 days, and 14 patients were

hospitalized for 7 days or longer. Fifteen patients experienced a total of 25 readmissions to the hospital during the
12-month follow-up period, and five patients were hospitalized a mean of 3.0 times. The most common primary
reasons for rehospitalization were nausea/vomiting/gastrointestinal symptoms (nine hospitalizations), and infection
(eight hospitalizations). Three patients were rehospitalized
for revisional operations: two for gastro-jejunal leaks and
one for gastro-jejunal ulcer. Finally, 17 patients made a total
of 21 emergency room visits during the 12-month followup period.
Among the 100 enrolled participants, eight were missing
some laboratory data (fasting lipids and/or glucose measurements) at baseline and were excluded from further
analyses, leaving 92 patients in our analytic sample. At 6and 12-month follow-up, 63 patients (68%), and 42 patients
(46%), respectively, returned for complete clinical and
laboratory assessments.
Of the 92 adults in our study population, the mean age
was 46 years and 78% were women (Table 1). All were
nonsmokers before surgery. The mean BMI was 51 kg/m2,
with 49% having a BMI of 50 kg/m2 or greater. The
baseline characteristics of women and men were similar in
most respects; however, women had higher total cholesterol
levels than men. As expected, women also had significantly
higher baseline HDL cholesterol levels than did men. At
baseline, 38% of patients had diabetes, and 26% had
uncontrolled hypertension (systolic 140 mmHg or diastolic 90 mmHg). Based on the Framingham risk score, the
predicted baseline 10-year cardiovascular risk was 6.2% for
women and 8.4% for men.
Mean weight losses were 31 kg at 6 and 12 months, and
mean changes in BMI were 10 and 11 kg/m2 at 6 and
12 months, respectively (Table 2). Patients experienced a

Table 1 Demographic and preoperative clinical characteristics of 92 Roux-en-Y gastric bypass cases, by sex
Demographic and preoperative characteristics

Women (n=72)

Men (n=20)

p value

Age (years), meanSD

Weight (kg), meanSD
BMI, meanSD
Superobese (BMI50; %)
Systolic blood pressure (mmHg), meanSD
Diastolic blood pressure (mmHg), meanSD
Fasting blood glucose (mg/dl), meanSD
HbA1c %, meanSD
Total cholesterol (mg/dl), meanSD
HDL cholesterol (mg/dl), meanSD
LDL cholesterol (mg/dl), meanSD
Triglycerides (mg/dl), meanSD
10-year risk of cardiovascular disease (%)




BMI body mass index.

OBES SURG (2009) 19:184189


Table 2 Baseline, 6-month, and 12-month clinical and laboratory measures of 92 Roux-en-Y gastric bypass cases




p valuea



p valueb

Weight (kg), meanSD

BMI, meanSD
Systolic blood pressure (mmHg), meanSD
Diastolic blood pressure (mmHg), meanSD
Fasting blood glucose (mg/dl), meanSD
HbA1c %, meanSD
Total cholesterol (mg/dl), meanSD
HDL cholesterol (mg/dl), meanSD
LDL cholesterol (mg/dl), meanSD
Triglycerides (mg/dl), meanSD
10-year risk of cardiovascular disease (%)








BOCF baseline-observation carried forward.

p value for baseline vs. 6-month BOCF comparison.
p value for baseline vs. 12-month BOCF comparison.

modest, but statistically significant, reduction in systolic

blood pressure over the 12-month follow-up; however,
diastolic blood pressure readings did not change significantly. Among 24 patients with uncontrolled hypertension
at baseline, the mean decrease in systolic blood pressure at
12 months was 153 mmHg (p=0.0002).
Fasting blood glucose and HbA1c levels decreased
significantly by 6 and 12 months following LRYGBP
(Table 2). Among patients with diabetes at baseline, the
mean changes in fasting glucose and HbA1c at 12 months
were 37 9 mg/dl (p = 0.0001) and 1.1 0.3% (p =
0.0004), respectively. Triglyceride and total and LDL
cholesterol levels were all significantly reduced at 6 and

10-year Cardiovascular Risk (%)

p = 0.003

12 months (Table 2). HDL cholesterol levels decreased at

6 months but increased at 12 months.
The average 10-year cardiovascular risk decreased from
6.7% at baseline to 5.2% at 6 months and 5.4% at
12 months follow-up. Assuming no change in cardiovascular risk among morbidly obese patients who do not
undergo bariatric surgery, this represents an estimated
absolute risk reduction of 1.3%; thus, 77 morbidly obese
patients would have to undergo LRYGBP to avert one new
case of cardiovascular disease over the ensuing 10 years
(NNT=77). Although baseline levels of risk differed
between men and women, reductions in cardiovascular risk
occurred to a similar degree in both (Fig. 1). Patients with
diabetes and those older than 45 years had larger decreases
in 10-year cardiovascular risk, compared to adults without
diabetes and those younger than 45 years (Fig. 1).

p = 0.0004



p = 0.048

p = 0.002

p = 0.01

p = 0.02



Diabetic Non-diabetic Age >=45 Age <45


12 month

Fig. 1 Change in predicted 10-year risk of cardiovascular disease for

men vs. women, patients with vs. without diabetes, and patients older
vs. younger than 45 years

Several investigators have independently reported improvements in blood pressure [15, 16], serum cholesterol level
[17, 18], fasting blood sugar level [19, 22], or HbA1c level
[19] following bariatric surgery. However, few studies have
simultaneously examined changes in all of those risk
factors. In the present study, we found that LRYGBP is
associated with statistically significant improvements in all
cardiovascular risk factors and a corresponding decrease in
predicted 10-year risk of cardiovascular disease. Our results
suggest that one would need to treat 77 morbidly obese
patients with LRYGBP to prevent one incident case of
cardiovascular disease over the ensuing 10 years.
Our findings are consistent with those of three recent
studies of changes in cardiovascular risk following RYGBP


[1012]. Vogel and colleagues reported a retrospective

analysis of 109 consecutive RYGBP cases at one hospital in
Michigan. Their findings for changes in body weight,
HbA1c, glucose, triglycerides, and HDL, LDL, and total
cholesterol were similar to ours in magnitude and direction.
Vogel et al. reported 10-year Framingham cardiovascular
risk estimates at baseline and 17 months after surgery of
65% and 43% (p<0.0001), respectively. Torquati et al.
reported 10-year Framingham cardiovascular risk estimates
at baseline and 2 months after surgery of 5.4% and 2.7%
(p<0.001)as well as a reduction in the prevalence of
diabetes from 28% to 6% (p=0.001). The cohorts actual
rate of coronary heart disease events was 17% (five of 500).
At 5 years, this was lower (p=0.001) than the rate
predicted. Batsis et al. [11] constructed a novel predictive
model of cardiovascular risk based on National Health and
Examination Survey (NHANES) I data and applied their
model to a historical cohort of 197 consecutive RYGBP
cases and 163 nonoperative morbidly obese patients who
declined bariatric surgery in Minnesota. They reported that
the estimated 10-year risk for cardiovascular events for the
operative group decreased from 37% at baseline to 18% at a
mean of 3.3 years of follow-up, while the estimated risk for
the nonoperative group remained unchanged over the same
time period at 30%.
The Batsis cohort had higher cardiovascular risk than did
of the cohorts of Vogel and Torquati and colleagues. This is
likely related to differences between their risk prediction
models, especially the outcome definition (i.e., Batsis et al.
defined cardiovascular events as any hospitalization or death
coded as cardiovascular under the International Classification of Disease-9 coding system). They also included BMI as
an independent predictor of cardiovascular risk [11]. As a
result of those systematic differences in modeling, Batsis
and co-authors estimated that approximately six morbidly
obese patients would need to undergo RYGBP to avert one
cardiovascular event over 10 years (NNT=6.4).
Our study has several limitations. We had high rates of
loss to follow-up in our population at 6 and 12 months.
Thus, for our data analyses, we chose to present the
conservative BOCF approach, which assumes no change
from baseline among cases with missing values. Our use of
the BOCF approach would bias our results toward the null
hypothesis of no effect of LRYGBP on cardiovascular risk.
Despite this assumption, we found a clinically large and
statistically significant effect for our primary outcome and
all our secondary cardiovascular risk outcomes. Given our
missing data, the true value for each of our outcomes
most likely lies somewhere between the BOCF and
completers-only results (Table 2). A lack of detailed
information on our cohorts changes in medical therapy
for hypertension, diabetes, and hyperlipidemia also limits
our study. We cannot assume that all of the cardiovascular

OBES SURG (2009) 19:184189

risk reduction we observed is due to LRYGBP per se;

however, other studies have observed reductions in medical
therapy following bariatric surgery [11, 23, 24], suggesting
that the LRYGBP-induced weight loss is the primary causal
mechanism for improvements in cardiovascular risk. Finally, our study is limited in its generalizability: Our sample is
primarily Caucasian and privately insured, and patients
were treated at a single hospital in the Midwest. Further
research is needed to validate our findings in settings with
greater racial and socioeconomic diversity.
Those limitations notwithstanding, our study adds to a
growing body of evidence indicating that bariatric surgery
effectively reduces body weight and improves or eliminates
obesity-related comorbidities [811]. Furthermore, recent
studies indicate that the 30-day risk of death due to surgery
is low (<1%) and declining [25, 26]. We report a 1-year
mortality rate of 1% in this series, which is consistent with
national estimates [25, 26]. However, the complication rate
of bariatric surgery is not negligible. In our sample, 15
patients were rehospitalized at least once in the 12 months
after surgery, and five patients were hospitalized a mean of
3.0 times. Other studies indicate that hospitalization for
complications after bariatric surgery more than doubles the
costs of care for affected patients [27].
In summary, our findings indicate that LRYGBP is
associated with improvements in cardiovascular risk factors
and a corresponding decrease in predicted 10-year risk of
cardiovascular disease. Further research is needed to help
optimize patient selection and reduce complications related
to bariatric surgery. Success in that endeavor, when
combined with evidence on improvements in cardiovascular
risk and long-term survival, will surely push the benefitrisk
ratio for bariatric surgery well above any contemporary
medical weight loss interventions for most morbidly obese
Acknowledgments This project was supported by funding from the
University of Cincinnati Rehn Family Research Award, the Departments of Medicine and Surgery at the University of Cincinnati, and
the Group Health Center for Health Studies.

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