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#556-Matlock Galley - 01

General Surgery
SURGICAL TECHNOLOGY INTERNATIONAL XXV

Sonographic Evaluation of Autologous


Fat Transfer to The Biceps and Triceps
DAVID MATLOCK, MD, MBA, FACOG
CEO
VASER HI DEF LIPOSCULPTURING INSTITUTE OF BEVERLY HILLS
LOS ANGELES, CALIFORNIA

ALEXANDER SIMOPOULOS, MD, FACOG


MEDICAL DIRECTOR
VASER HI DEF LIPOSCULPTURING INSTITUTE OF BEVERLY HILLS
LOS ANGELES, CALIFORNIA

ABSTRACT
utologous fat transfer (AFT) for increased tissue bulk has been reported on since the 1990s, and has

A increased by 26.6% from 2009 to 2010. Despite this increase, there is relatively little published data.

While the described method of AFT to muscle tissue has advantages of being matched to the patient and

retaining all the properties of tissue, challenges arise due to the size of muscles, the ability to measure imme-

diate and long term placement and retention, and frequency of aberrant anatomy in order to avoid vascula-

ture and potential complications; reportedly 10% to 27%. We present the results of a study using ultrasound
visualization to assist in AFT to the biceps and triceps.

Ten male subjects were treated with AFT to the biceps and triceps under intraoperative ultrasonic

visualization. Pre- and post-operative circumferential measurements were collected as well as follow-up at

weeks six and 12.

A mean of 90 cc and 110 cc were injected subfascially into the biceps and triceps, respectively, of 10 study

subjects. Post-operative circumferential measurements increased by a mean of 3.0 cm and follow-up

measurements were found to have increased by a mean of 3.3 cm over baseline. No compartment syndrome,

fat emboli or significant pain were experienced by any subject in this study.

Autologous fat transfer to smaller muscle areas such as the bicep and tricep is both feasible and safe with

consistent and durable results. The addition of pre-operative ultrasound imaging provides a means to safely

avoid critical structures such as vasculature; and intra-operative ultrasound allows the surgeon to directly

visualize the relevant anatomy as each injection is performed confirming intramuscular placement.

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Sonographic Evaluation of Autologous Fat Transfer to The Biceps and Triceps


MATLOCK/SIMOPOULOS

performed safely in the extremities with States. The study was registered on clin-
sustainable results, although a Medline icaltrials.gov under study number
INTRODUCTION
search did not yield literature on subfas- NCT01313000 and approved by Liberty
Body contouring has been a widely cial intramuscular injection of autolo- IRB (Deland, FL).
accepted procedure since the 1980s 1 gous fat into the biceps and triceps. All male subjects presenting to the
with the advent of artificial implants One potential pitfall of this tech- investigator for treatment using ultra-
combined with liposuction to achieve an nique is the possibility of the injection sound-assisted liposuction (VASER)
aesthetic result. Artificial implants how- cannula intersecting with and/or punc- were considered potential study candi-
ever, do not completely replicate the turing blood vessels or nerves. Carde- dates and were screened for interest and
feel of living tissue and can suffer from nas-Camarena 4 reported one case of eligibility. Subjects who did not meet all
significant scar tissue encapsulation with suspected fat embolism in their series of inclusion/exclusion criteria were not
associated hardness and poor cosmetic 62 patients (1.6%). To avoid this poten- enrolled.
results. tially fatal complication, surgeons his- For inclusion in the study, subjects
Autologous fat transfer is the reinjec- torically relied solely on experience and must have fulfilled all of the following
tion/reinsertion of a subject’s own fat feel to avoid these critical nerves and criteria:
after it has been removed from another blood vessels. As autologous fat transfer
body area. This treatment may be for becomes more commonplace, an Male
therapeutic or cosmetic benefit and has increasing number of less experienced Between 20 and 50 years of age,
been documented as early as the 1890s2 surgeons will attempt the technique. inclusive, on the day of enroll-
when upper arm fat was used to repair In this study, we evaluated the use of ment
the cheek of a subject. In the 1980s, non-invasive, high frequency, ultrasonic Scheduled for abdominal lipo-
Bircoll 3 introduced the use of small imaging as a tool in the fat transfer pro- suction
injections of fat using liposuction tech- cedure to assist the physician in both Desired autologous fat transfer
niques. avoiding critical structures and provid- to the upper arms
Autologous fat transfer to increase ing high specificity for placement of
bulk has been more widely reported injected fat into the muscle. Additional- The following were regarded as exclu-
since the 1990s4-8 and offers the advan- ly, imaging was used pre-operatively to sion criteria:
tages of being immunologically matched assess any aberrant anatomy and for
to the patient. Autologous fat transfer pre-measurement of the bicep and tri- Current enrollment in another
has been used in facial, lip, hand, breast, cep; as well as post-operatively both device or drug study that had
buttock, and limb procedures by physi- short term and long to visualize the not completed the required fol-
cians around the world. 9-11 In these retained volume and placement of the low-up period, or has completed
series, autologous fat has been trans- re-injected fat. all other study-required follow-
ferred from one body area and injected up less than 30 days before
in target areas surrounding muscle to enrolment in this study
provide a contouring effect. Mojallal12 Materials andAND
Methods Undergoing body contouring for
reported a series of 20 subjects injected reconstruction following injury
MATERIALS METHODS
with autologous fat to resolve limb atro- or disease
phies. In these subjects, an average cir- Subject population Deemed an inappropriate candi-
cumferential augmentation of 1.9 cm Observational data were collected date for the surgical procedures
per injection was achieved with high from subjects requesting muscle defin- for any reason
subject satisfaction over two years of ing liposuction in conjunction with Unwilling to undergo the study
follow-up. This cohort demonstrated autologous fat transfer to the biceps and procedures or participate fully in
that autologous fat transfer could be triceps at one center in the United all follow-up

a b
Figure 1. The TouchView™ ultrasonic imaging probe.

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#556-Matlock Galley - 01

General Surgery
SURGICAL TECHNOLOGY INTERNATIONAL XXV

VASER® Ultrasonic Liposuction


System LIPOSUCTION SYSTEM
VASER® ULTRASONIC

The VASER ® Ultrasonic Assisted


Liposuction System (Sound Surgical
Technologies, LLC, Louisville, Col-
orado) consists of a low frequency
ultrasound generation system (36 kHz)
and a probe that delivers the ultrasonic
energy to surrounding tissue. The
VASER® is used as an adjunct to stan-
dard suction-assisted liposuction. The
ultrasonic energy delivered separates fat
cells from each other and surrounding
tissue, making aspiration of the targeted
fat deposits easier for the physician and
less traumatic for the patient. The
VASER® System is cleared for physician
Figure 2. Ultrasonic image showing large intra-muscular vessels. use by the FDA under K991791.

TouchView™ Ultrasonic Imaging


System IMAGING SYSTEM

TOUCHVIEW ULTRASONIC

The TouchView™ Ultrasonic Imaging


System (Sound Surgical Technologies,
LLC, Louisville, Colorado) comprises
an ultrasound imaging platform
(T2000+ system manufactured by Tera-
son Corporation) with a unique linear
probe (TouchView™ Probe, manufac-
tured by Blatek, Inc., State College, PA)
specifically designed for the use of aes-
thetic physicians. The system operates
in the 5 to 12 MHz range with a nomi-
nal frequency of 8 MHz. The design of
the finger probe allows the physician to
easily visualize subcutaneous structures
while maintaining tactile contact with
the patients’ tissue. The finger probe is
Figure 3. Ultrasonic image showing injection cannula.

non-sterile and may be used in a sterile


sleeve during aseptic procedures. The
Terason T2000+ Ultrasonic Imaging
System is cleared for physician use by
the FDA under K080234.

Subject preparation and


treatment
This was a non-randomized open-
label study in 10 human participants.
Each participant was consented by the
Principal Investigator, Co-Investigator
or Study Coordinator. Potential candi-
dates were screened by the study center
for inclusion in the study. If a subject
was suitable for inclusion he was
informed of the study, all the study
requirements, and the risks/benefits of
participation. He was also presented
Figure 4. Ultrasonic image showing injection of transferred fat. with an informed consent document to

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Sonographic Evaluation of Autologous Fat Transfer to The Biceps and Triceps


MATLOCK/SIMOPOULOS

Figure 5. Upper arm change pre- and post-operatively. Figure 6. Upper arm circumferential change over follow-up.

review. If the subject consented to par- lature to be avoided during the injection During each transfer, the injection
ticipate by signing the informed consent process. The pre-operative measure- cannula and injected fat were visualized
document, he was assigned a subject ments, photography, and imaging were using the TouchView™ System (Fig. 3
identifier and underwent an initial eval- repeated as soon as the subject was suit- and Fig. 4 respectively). The amount of
uation, including photographs and mea- ably recovered from the surgical proce- fat injected was determined by the
surements of the area to be treated, dure. amount of available harvested fat and
height, weight, and a subject history. aesthetic effect as determined by the
The subject was then treated under Follow-up surgeon. Subjects underwent average
the direction of the Principal Investiga- At approximately six and 12 weeks injections of 90.0 +/- 30.8 cc (range
tor using the VASER ® Ultrasound after surgery, the pre-surgery measure- 40–160 cc) to each bicep and 109.8
Assisted Liposuction System in the tar- ment, photographs and imaging were +/- 40.7 (range 18–160 cc) to each tri-
get area (areas included in this study repeated. cep, yielding a total injection to each
were abdomen, obliques/flanks, infra- upper arm of 199.8 +/- 66.0 (range
axilla, biceps, and triceps) until the Statistical measures (58–320 cc).
desired aesthetic affect was achieved. Circumferential measurements from Each subject was measured for upper
The fat removed from the subject the upper arms were analyzed separate- arm circumference at the level of the
remained in a sterile, isolated container ly and combined where paired data peak of the bicep when relaxed. Pre-
for later injection into the subject. Once were available. Subject satisfaction sur- operatively, subject measurements were
the liposuction procedure was complete, veys were also administered at follow- 34.8 ± 3.1 cm. Subjects were again
the upper arms of the subject were pre- up. All tests applied were two-tailed, measured immediately post-operatively
pared for cosmetic fat injection. with ? set at 0.05. Paired t-tests were to reduce any artifact due to post-oper-
The adipose tissue removed during performed for normally distributed ative swelling. Post-operative measure-
the liposuction procedure was washed data and the Wilcoxon Signed-Rack test ments averaged 37.5 ± 2.4 cm; a mean
with a gentamycin and cefazolin solu- was used for data that was not normally increase of 2.6 ± 1.2 cm, which was
tion before injection into the subject. In distributed. found to be statistically significant (p <
addition, before intra-muscular injec- 0.001 for a two-tailed test). There was
tion of the processed fat, the subject no correlation between the amount of
was administered 600 mg of clin- Results fat injected and the increase in circum-
damycin intravenously. ferential measurement either as
RESULTS
Injection was accomplished using absolute measurement or as a percent-
custom 16G 7 cm, 15 cm and 30 cm Ten subjects were treated at one cen- age change. The post-operative circum-
cannulae. These cannulae facilitate a sin- ter in the United States beginning in ference did correlate with pre-operative
gle injection site and are long enough to March 2011 and ending in December measurement, with an R 2 of 0.91
reach the extremity of the muscle. 2011. All subjects were male with an (Fig. 5).
The Investigator then injected the average age of 34.6 ±5.3 years [22.8 to Through the 12-week follow-up, cir-
treated fat under sterile technique into 38.7]. The volume of fat transferred cumferential changes seen immediately
the muscles of the upper arms of the into each tricep was 109.8 ± 40.7 cc post-operatively remained (Fig. 6) with
subject, specifically the biceps brachii [18 to 160 cc] and into each bicep was p < 0.001 at both six-week and 12-
and triceps brachii. Both arms were 90.0 ± 30.8 cc [40 to 160 cc]. week follow-up using a two-tailed,
treated to achieve the cosmetic effect. Pre-operatively, using Doppler func- paired t-test.
The TouchView™ Ultrasonic Imaging tions, large blood vessels in the target Aesthetically, each subject showed
System was used to verify sub-facial muscle were readily identified (Fig. 2) improvement in appearance that was
blunt needle placement into the muscle using the TouchView™ System, allowing sustained over follow-up (Fig. 7, Fig. 8,
and visualize the injection process. for safe, accurate injection and avoid- and Fig. 9).
Imaging was also used to identify vascu- ance of critical structures. To determine if the increase in arm

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#556-Matlock Galley - 01

General Surgery
SURGICAL TECHNOLOGY INTERNATIONAL XXV

circumference was the result of the


autologous fat transfer or an increase in
activity by subjects, each arm was res-
canned for evidence of graft survival.
Figure 10 and Figure 11 show similarly
positioned ultrasound scans taken at six-
and 12-weeks post-operatively. As can
be seen from these images, the trans-
ferred fat has similar textural qualities
to the operative images (Fig. 4) and has
similar shape over time. There is a small
amount of remodeling, however the
areas of injected fat are readily identi-
fied three months after injection.

Subject satisfaction
Subjects were asked to rate their sat-
isfaction with their arms and overall
appearance pre-operatively and at fol-
low-up on a -5 to +5 integer scale. Sub-
Figure 7. Subject 007 pre- and post-operative photographs.

jects reacted positively to the procedure


and the immediacy of results, evidenced
by the significant increases over baseline
within six-weeks (p = 0.016 arms, p =
0.014 overall). Figure 12 and Figure 13
show the mean subject responses pre-
operatively and at follow-up.

Safety
There have been no adverse events
reported in this subject population.
There has been no compartment syn-
drome, embolism, edema or other
severe conditions.
Figure 8. Subject 009 pre- and post-operative photographs.

DiscussionDISCUSSION

The ASPS Fat Graft Task Force con-


cluded13 that there was a tremendous
need for high-quality clinical studies of
autologous fat grafting. Key to these
studies will be the adequate visualiza-
tion and quantification of fat grafts both
intra- and post-operatively. The general
procedure for autologous injection of
harvested fat into other body areas is
well established for large muscle
groups, but there has been a paucity of
consistent, scientifically based research
in the area. This study is one of the first
to evaluate healthy subjects with objec-
tive criteria; no underlying pathology in
Figure 9. Subject 010 pre- and post-operative photographs.

our series. The results of the study were sion and virtually no risk of rejection, as showing that a wide range of volumes
found to be durable up to 12 weeks fol- only soft tissues, completely compatible can be used to achieve the desired aes-
lowing the initial fat injections. In addi- with the patient are used. Another sig- thetic effect without the risk of com-
tion to the lasting results, the procedure nificant contrast to artificial grafts is partment syndrome.
is well tolerated with a high degree of that the treatment can be repeated sim- The sub-fascial and intramuscular
post-operative satisfaction. In contrast ply, without the need to remove scar nature of the injection process may be a
to artificial implants in these areas, tissue or prior implants. Up to 160 cc key factor in the consistent retention of
autologous fat carries little risk of ero- was injected unilaterally in this study, the graft over the course of follow-up

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#556-Matlock Galley - 01

Sonographic Evaluation of Autologous Fat Transfer to The Biceps and Triceps


MATLOCK/SIMOPOULOS

Figure 10. Subject 008 six- and 12-week ultrasonic images. Figure 11. Subject 010 six- and 12-week ultrasonic images.

and the consistency in ultrasound area, reducing the apparent volume amount of injected volume that remains
images over time. The fascia and muscle increase. as fat and the amount that converts to
tissue serve to contain the injected fat, The subfascial injection process may muscular tissue.
both maintaining its implanted configu- also assist in increasing fascial pliability Inexperience is only one risk factor
ration and protecting it from external and thereby allowing for greater cir- for percutaneous procedures. Aberrant
manipulation. In the case of subcuta- cumferential increase by hypertrophic anatomy may result in even experienced
neous injection, the fat can be easily gain. In addition, adipose tissue is surgeons unknowingly disrupting both
moved in the subcutaneous tissue lay- increasingly being used as a source of blood vessels and nerves. Cadaveric
ers, increasing the likelihood of resorp- adult stem cells. Longer term studies studies have shown rates of aberrant
tion and/or thinning of the injected will be needed to determine the vessels ranging up to 27% in the

Figure 12. Subject satisfaction with arm appearance over time. Figure 13. Subject satisfaction with overall appearance over time.

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#556-Matlock Galley - 01

General Surgery
SURGICAL TECHNOLOGY INTERNATIONAL XXV

extremities, and there is at least one addition ultrasound imaging provides Augmentation of the buttocks by micro fat
case report of arterial damage due to pre-operatively a means to quickly eval- grafting. Aesthet Surg J. 2001;21(4):311–9.
aberrant anatomy.14-16 In this case, the uate potential vascular, nerve hazards, 6. Valeriani M. GLADI: Gluteal adipose
implant. A new technique for the reshaping of
superior gluteal artery was injured dur- and aberrant anatomy; intra-operatively the gluteal-trochanteric region. Acta Chir
ing the percutaneous placement of allows the surgeon to directly visualize Plast. 2004;46(3):70–3.
iliosacral screws. The injury was only the structures as each injection is per- 7. Mendietta CG. Gluteal reshaping. Aesthet
identified after excessive bleeding from formed; and post operatively to mea- Surg J. 2007;27(6):641–55.
the puncture site was observed. The sure both short term and long term 8. Nicareta B, Periera LH, Sterodimas A,
authors advise that the possibility of sustainability and placement of the Illouz YG. Autologous gluteal lipograft. Aes-
thetic Plast Surg. 2011 Apr; 35(2):216-24.
anatomical variance should be consid- injected fat. STI Epub 2010 Sep 25.
ered and sought after with preoperative 9. Mendieta CG. Gluteoplasty. Aesth Surg J,
visualization. In cosmetic procedures, 2003:23(6);441–55.
the surgeon must also determine intra- Authors’ Disclosures 10. Pereira LH, Radwanski HN. Fat Grafting
operatively the best sites for injection, of the buttocks and lower limbs. Aesth Plas
AUTHORS’ DISCLOSURES
based on the result desired. Surg, 1996:20(5);409–16.
The TouchView™ System allows the The authors have no actual or poten- 11. Pereira LH, Sterodimas A. Composite
body contouring. Aesth Plas Surg,
surgeon to not only pre-operatively tial conflicts of interest in relation to 2009:33(4);616–24.
visualize major structures and aberrant this paper. 12. Mojalla A, et.al. Analysis of a series of
anatomy within the area targeted for autologouos fat tissue transfer for lower limb
autologous fat injection, it facilitates the atrophies. Ann Plast Surg,
injection process, reduces the amount References 2008:61(5);537–43.
of manual manipulation required, and 13. Gutowski KA, et.al. Current applications
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Autologous fat transfer to smaller structive Surgery: Volume 104(5) October
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