You are on page 1of 9

@

Cosmetic Medicine

Downloaded from https://academic.oup.com/asj/advance-article-abstract/doi/10.1093/asj/sjaa075/5854116 by Uppsala Universitetsbibliotek user on 08 June 2020


Aesthetic Surgery Journal
2020, 1–9
Descriptive Analysis of 213 Positive Blood © 2020 The Aesthetic Society.
Reprints and permission:
Aspiration Cases When Injecting Facial Soft journals.permissions@oup.com
DOI: 10.1093/asj/sjaa075
Tissue Fillers www.aestheticsurgeryjournal.com

Fang Wen Tseng, MD; Kanthi Bommareddy, BSc; Konstantin Frank,


MD; Claudio DeLorenzi, MD; Jeremy B. Green, MD; Neil Sadick, MD;
Rebecca Fitzgerald, MD; Emy C. Onishi, MD; Arthur Swift, MD; and
Sebastian Cotofana, MD, PhD

Abstract
Background:  Pre-injection aspiration procedures could increase safety during soft tissue filler injections. However, various
influencing factors have been detected in vitro that could result in false negative aspiration results.
Objective:  A case series was retrospectively investigated to identify factors contributing to positive blood aspiration pro-
cedures in vivo.
Methods:  This study evaluated 213 clinical cases positive for blood aspiration documented in an Asian population: 208
females (43.8 ± 7.2 years old) and 5 males (46.8 ± 7.8 years old) during soft tissue filler injections. Injection location, layer
(depth) of injection, product injected, size of utilized needle (gauge), length of needle (inch), priming of needle (yes/no),
injection angle (degree), and time until blood was visible in the needle hub (seconds) were evaluated.
Results:  The most frequent location where a positive aspiration was observed was the pyriform fossa (n = 56; 26.3%),
the most frequent plane was the supra-periosteal plane (n = 195; 91.5%), and the most frequent needle utilized was a 27G
needle (n = 125; 58.7%). Statistically significantly more positive cases were identified when the needle was primed com-
pared with an unprimed needle (P < 0.001, which was independent of the product). The estimated incidence rate was
0.04% to 0.9% for having positive aspiration procedures per total performed injection procedures.
Conclusions:  Pre-injection aspiration could be a valuable tool to prevent accidental intravascular injection of soft tissue
filler. The results of the present investigation show that aspiration can be performed with an acceptable aspiration time,
that is, less than 2 seconds, if a suitable product/needle combination is chosen.

Level of Evidence: 4 

Editorial Decision date: March 17, 2020; online publish-ahead-of-print June 6, 2020.

Dr Tseng is a physician in private practice in Taipei, Taiwan. Mr Philippines. Dr Swift is a physician in private practice, Montreal,
Bommareddy is a Medical Student, Division of Anatomy, Department Canada. Dr Cotofana is an Associate Professor, Department of
of Medical Education, Albany Medical College, Albany, NY. Dr Frank Clinical Anatomy, Mayo Clinic College of Medicine and Science,
is a Resident, Department for Hand, Plastic, and Aesthetic Surgery, Rochester, MN.
Ludwig – Maximilians University, Munich, Germany. Dr DeLorenzi is
a plastic surgeon in private practice in Toronto, Canada. Dr Green Corresponding Author:
is a dermatologist in private practice, Coral Gables, FL. Dr Sadick Dr Sebastian Cotofana, Department of Clinical Anatomy, Mayo Clinic
is a Physician, Department of Dermatology, Weill Cornell Medical College of Medicine and Science, Mayo Clinic, Stabile Building 9–38,
College, New York, NY. Dr Fitzgerald is a Physician, Division of 200 First Street, Rochester, MN 55905, USA.
Dermatology, University of California Los Angeles (UCLA), Los E-mail: cotofana.sebastian@mayo.edu; Instagram:
Angeles, CA. Dr Onishi is a physician in private practice in Manila, @professorsebastiancotofana
2 Aesthetic Surgery Journal

According to the annual statistical report released by The METHODS


Aesthetic Society, a total of 810,240 soft tissue filler in-
jections were performed in 2018 in the United States.1 Study Sample
Concomitantly, the number of reported adverse events,

Downloaded from https://academic.oup.com/asj/advance-article-abstract/doi/10.1093/asj/sjaa075/5854116 by Uppsala Universitetsbibliotek user on 08 June 2020


This study is a retrospective analysis of 213 positive blood
of which tissue loss and intravascular related visual com-
aspiration procedures obtained during facial soft tissue
promises are considered to be the most catastrophic,
filler injection in Asian patients. All documented cases were
increased by 130% between 2015 and 2019.2,3 The cur-
consecutive patients injected between September 2015
rent accepted pathophysiological mechanism behind in-
and August 2019 (48 months) by the first author (F.W.T. has
travascular related visual compromises is the inadvertent
12 years of experience with facial soft-tissue filler injections
injection of filler material into the arterial vascular circu-
at the time of submission) in various facial regions utilizing a
lation with subsequent transportation to the ophthalmic
variety of facial soft tissue fillers (Tables 1 and 2). All patients
artery vascular territory. There, either the central retinal
were injected by the same specialist (F.W.T.) according to
artery itself or the multiple posterior ciliary arteries can be
their individual aesthetic indications. Patient records were
embolized by the filler material, resulting in occlusion and
retrospectively analyzed and anonymized for further stat-
subsequent ischemia of the retina.4
istical processing. Written information and verbal explan-
Safety recommendations include low-pressure injec-
ations about the scope and goals of this retrospective
tions,5 utilization of a small bolus per pass,6 utilization (if
analysis were given to participants before inclusion in this
possible) of larger sized cannulas (22 gauge),5,7,8 the se-
study. Patient records were not analyzed if willingness
lection of safer injection planes,9 and the implementation
to participate was declined. Following the Declaration of
of a pre-injection aspiration procedure.10 The latter, how-
Helsinki, written informed consent and signed picture and
ever, is to date not universally accepted as mandatory in
photo release agreement were obtained from every pa-
all facial areas due to the potential for false negative re-
tient included. Patients were treated according to regional
sults. A false negative result would be defined as a nega-
laws and good clinical practice independent of their will-
tive aspiration occurring despite intravascular location of
ingness to share their data for this retrospective analysis.
the needle tip. This effect could be due to collapse of the
It is estimated that approximately 5760 to 7200 patients
arterial wall by the applied negative pressure during the
(ie, 120-150 patients per month) were injected during the
aspiration process11 or by a through and through phenom-
48-month observational period.
enon,10 where the needle tip is located intramurally or by
an impaired combination of filler viscosity and needle
characteristics (size and length). The latter false negative
Data Collected
aspiration scenario could result from the filler material The following data were collected on a routine basis and
being too viscous to allow retrograde migration and thus documented by the first author of the study during his
aspiration of blood in a needle with a small diameter and/ daily clinical practice treating consecutive patients: age,
or increased length. gender, facial region injected, layer (depth) of injection,
Previous studies investigated in vitro factors that could product injected, whether lidocaine was added to the in-
influence the outcome of performed aspiration proced- jected product, needle gauge and length, whether needle
ures, which included the viscoelastic properties of the priming was performed, injection angle, and time until
product,11-13 the plunger withdrawal time,12 the priming blood was visible in the needle hub (Tables 1-4). Data col-
of the needle,11 and the pullback volume.13 However, all lection was conducted in various clinics (F.W.T. practices in
these studies were conducted in a laboratory setting, multiple clinics) and during international travels of the first
which had obvious shortcomings when equated to real- author. Data analysis (not data collection) is the subject of
life conditions. this study.
We present a retrospective study summarizing data The products injected were Restylane Lyft/Perlane,
collected from 213 positive aspirations obtained in true Restylane, Restylane Vital (Galderma Pharma SA, Uppsala,
clinical settings over a period of 4 years. The analysis of Sweden); Juvederm Voluma, Juvederm Volift, Juvederm
this largest-to-date case series will hopefully increase Ultra Plus (Allergan PLC, Dublin, Ireland); Belotero
the understanding of the role of positive blood aspir- Balance (Merz Pharma GmbH & Co. KGaA, Frankfurt am
ations and reduce the incidence of adverse vascular Main, Germany); Hyadermis Smile (SciVision Biotech
events and ultimately increase patient safety during soft Inc., Kaohsiung, Taiwan); Elravie Deep line (Humedix,
tissue filler injections. Although no predictive statistical Anyang-si, Republic of Korea); Princess Volume (Croma-
inferences can be generated, descriptive data still have Pharma GmbH, Leobendorf, Austria); Sculptra (Sinclair
practical value. Pharma Ltd., London, UK); Sunmax Collagen Implant
Tseng et al 3

Table 1.  Number of Observed Positive Blood Aspirations at Respective Location and Depth of Needle Injection

Subdermal/superficial fat Submucosal Supraperiosteal Total count

Anterior inferior temple 0 0 2 2

Downloaded from https://academic.oup.com/asj/advance-article-abstract/doi/10.1093/asj/sjaa075/5854116 by Uppsala Universitetsbibliotek user on 08 June 2020


Anterior superior temple 0 0 42 42

Chin 0 0 15 15

Deep midfacial fat compartments 0 0 54 54

Forehead 0 0 8 8

Lateral midface (zygomaticomaxillary fissure) 0 0 5 5

Lips 2 1 0 3

Nasal dorsum 0 0 7 7

Nasal spine 0 0 3 3

Nasolabial sulcus 2 0 0 2

Posterior inferior temple 0 0 0 0

Posterior superior temple 0 0 5 5

Pyriform fossa 2 0 54 56

Superficial medial cheek fat compartment 11 0 0 11

Total count 17 1 195 213

(Sunmax Biotechnoloy CO., Ltd., Tainan, Taiwan); and Statistical Analyses


Artecoll (Canderm Pharma Inc., St. Laurent, Canada)
(Tables 2 and 4). Descriptive and comparative analyses were performed
using SPSS Statistics 23 (IBM, Armonk, NY). Statistical sig-
nificance was defined as P < 0.05. 
Criteria for Positive Blood Aspiration
Each included case was considered a “positive blood as-
RESULTS
piration case” if blood was visible in the needle hub during
needle insertion or during aspiration in the initiation phase General Description
of the filler injection. Aspiration was consistently performed
during each injection process (independent of the amount Patient demographics noted were: 213 participants aged
injected) and was characterized by the generation of nega- an overall mean of 43.9 ± 7.2 years (range, 24-64 years). Of
tive pressure in the needle by retracting the plunger of those, 208 were female (mean age, 43.8 ± 7.2 years; range,
the soft tissue filler syringe. The pullback volume until a 24-64  years) and 5 male (mean age, 46.8 ± 7.8  years;
positive case was noted was 0.05 to 0.5 cc. The gener- range, 37-57 years).
ated pressure was not measured objectively because the No adverse vascular adverse events and especially
cases occurred during daily clinical consults of consecu- no injection related visual compromise occurred during
tive patients. the evaluation period in patients with a positive aspiration
If the aspiration procedure was positive (independent procedure.
of the amount of blood visible in the needle hub), the pro-
cedure was immediately stopped, the needle removed, Estimate of Minimum and Maximum
and digital pressure applied. After a minimum time of 5
minutes, a different location in the same facial region
Incidence Rates
was targeted with a different injection angle utilizing a Only positive blood aspiration cases were retrospectively
different soft tissue filler syringe. In no case was the in- analyzed; no negative injection cases were utilized for
jection procedure continued after blood appeared in the comparisons. During the 48-month study period, an ap-
needle hub. proximate amount of 11,500 cc of filler material was utilized.
4 Aesthetic Surgery Journal

Table 2.  Number of Observed Positive Blood Aspirations for Products Contained in Syringe and Their Respective Dilution With
Lidocaine

0.05 cc 0.1 cc Other cc No lidocaine added Total count

Downloaded from https://academic.oup.com/asj/advance-article-abstract/doi/10.1093/asj/sjaa075/5854116 by Uppsala Universitetsbibliotek user on 08 June 2020


Artecoll 3 6 0 0 9

Belotero Balance 1 1 0 0 2

Elravie Deep Line 5 0 0 0 5

Hyadermis Smile 1 0 0 1 2

Juvederm Ultra Plus 15 1 0 0 16

Juvederm Volift 0 0 0 4 4

Juvederm Voluma 0 0 0 24 24

Princess Volume 1 0 0 0 1

Restylane 53 39 0 3 95

Restylane Lyft (Perlane) 2 0 0 12 14

Restylane Vital 0 1 0 0 1

Sculptra 0 0 38 0 38

Sunmax Collagen Implant 1 0 0 0 1

Unknown 0 1 0 0 1

Total count 82 49 38 44 213

The extrapolation for the computation of the incidence Injection Location


rate was performed based on the amount of filler material
injected rather than from the number of patients treated. The most frequent location for positive aspiration was the
Various amounts of filler material, that is, various numbers pyriform fossa with a total of n = 56 (26.3%), followed by the
of syringes and injection passes per patient, could be per- injection into the deep midfacial fat compartments (n = 54;
formed, thus influencing the number of performed aspir- 25.4%), anterior superior temple (n = 42; 19.7%), and chin
ation procedures per patient. (n = 15; 7.0%). Detailed information about all facial regions
The smallest amount of product injected during 1 injected can be found in Table 1 and Figure 1.
pass (1 pass refers to 1 injection and 1 aspiration proce-
dure per specific location) was 0.02 cc (commonly used Injection Depth
for lips, periorbital areas, nasolabial folds), whereas the
largest amount of product applied during 1 pass was 0.5 The most frequent plane where aspiration was positive
cc (commonly used for temples or chin). An approximate for blood was the supra-periosteal plane, that is, the injec-
range of incidence for having a positive blood aspira- tion was performed with the needle tip being in constant
tion event may be estimated utilizing this information to contact with the bone during the product application with
derive the minimum and maximum values. If all of the n = 195 (91.5%), followed by the subdermal plane with n = 17
filler material (11,500 cc) had been injected in boluses of (8.0%) and the submucosal plane in 1 case (0.5%) (Table 1).
0.02 cc per pass during the observational period, there Subdermal/submucosal plane refers to a very superficial
would have been 575,000 injection passes, resulting in plane right deep to the dermis or the mucosa of the dry
a minimum incidence rate of 213/575,000 (0.037%), or red lip.
1 of 2700 injection passes. If all the filler material had In the supraperiosteal plane of the pyriform fossa and
been delivered in boluses of 0.5 cc per pass, there of the deep midfacial fat compartments, n = 54 positive
would have been 23,000 injection passes, resulting in case were recorded each, representing 25.4% of all cases.
a maximum incidence rate of 213/23,000 (0.926%), or 1 Positive cases were recorded in the subdermal plane of
of 108 passes. the superficial cheek fat compartments (n = 11; 5.2%), the
Tseng et al 5

Downloaded from https://academic.oup.com/asj/advance-article-abstract/doi/10.1093/asj/sjaa075/5854116 by Uppsala Universitetsbibliotek user on 08 June 2020


Figure 1.  Collage of 24 positive blood aspiration cases arranged by region observed in the retrospectively investigated 213
clinical cases. The mean age of the displayed patients is 40.38 ± 7.9 years and the gender distribution is 22 females and 2
males.

nasolabial sulcus (n = 2; 1.0%), the pyriform fossa (n = 2; Table 3.  Number of Observed Positive Blood Aspirations for
1.0%), and the lips (n = 2; 1.0%) (Table 3). Differently Used Needle Sizes (23G-30G) and Whether Needle
Was Already Filled With Product on Injection (Primed) or Not
(Nonprimed)
Needles Utilized Primed Nonprimed Total count

The most frequently utilized needle size was a 27 G 23G, 1” 1 0 1


(n = 125; 58.7%), followed by 25 G (n = 44; 20.7%) and 29
24G, 1” 1 0 1
G (n = 36; 16.9%). Detailed information about needle sizes
and length utilized are given in Table 3. 25G, 1.5”, 1”, 5/8”, ½” 36 8 44
Five positive cases (2.3%) were recorded utilizing a 30
26G ½” 1 0 1
G needle, and 1 case (0.5%) was recorded utilizing a 23G
needle targeting the supraperiosteal plane of the anterior 27G, ½” 102 23 125
superior temple (Table 3).
29G, ½” 29 7 36

30G, ½” 5 0 5
Injection Technique
Total count 175 38 213
The injection angle of the performed needle injections
ranged between 90°C (perpendicular to the bone surface)
performed in 162 cases (76.1%), 45°C (oblique dermal ac- cases injected at a 10°C angle were n = 11 in the superficial
cess) in 38 cases (17.8%), and 10°C (almost parallel to the medial cheek fat compartment (5.2%) and 1 case each in
skin surface) in 13 cases (6.1%). The recorded positive the nasolabial sulcus and the lips (0.5%).
6 Aesthetic Surgery Journal

Table 4.  Cross-Tabulation Between Injected Product and Utilized Needle Sizes and Lengths of 213 Positive Aspiration Events

30 G, 1/2” 29 G, 1/2” 27 G, 1/2” 26 G, 1/2” 25 G, 1.5” 25 G, 1” 25 G, 5/8” 25 G, 1/2” 24 G, 1” 23 G, 1” Total count

Artecoll 1 8 9

Downloaded from https://academic.oup.com/asj/advance-article-abstract/doi/10.1093/asj/sjaa075/5854116 by Uppsala Universitetsbibliotek user on 08 June 2020


Belotero Balance 2 2

Elravie Deep Line 5 5

Hyadermis Smile 2 2

Juvederm Ultra Plus 16 16

Juvederm Volift 4 4

Juvederm Voluma 24 24

Princess Volume 1 1

Restylane 23 72 95

Restylane Lyft (Perlane) 12 2 14

Restylane Vital 1 1

Sculptra 9 4 23 1 1 38

Sunmax Collagen Implant 1 1

Unknown 1 1

Total count 5 36 125 1 9 4 23 8 1 1 213

Needle Priming frequent location for positive aspiration was the pyriform


fossa (n = 56; 26.3%), followed by the deep midfacial fat
In 175 of the positive cases (82.2%), the needle was primed compartments (n = 54; 25.4%), anterior superior temple
with product (independent of the product utilized), whereas (n = 42; 19.7%), and chin (n = 15; 7.0%). The most frequent
the needle was empty during the aspiration procedure in plane where aspiration was positive for blood was the
38 of the positive cases (17.8%). No statistically significant supra-periosteal plane (n = 195; 91.5%), followed by the
difference in the distribution of the depth of injection vs the subdermal plane (n = 17; 8.0%) and the submucosal plane
priming of the needle was detected (P = 0.890). in 1 case (0.5%). Positive cases were recorded for various
needle sizes: 27 G (n = 125; 58.7%), followed by 25 G
Time Until Blood Was Visible (n = 44; 20.7%) and 29 G (n = 36; 16.9%). More positive
cases were identified when the needle was primed com-
In n = 210 (98.6%) cases, blood was visible in the needle pared with an unprimed needle (175 vs 38 cases), which
hub within less than 2 seconds after the initiation of the was independent of the product present in the needle. In
aspiration procedure, whereas in n = 3 cases (1.4%) no the great majority of the cases (n = 210; 98.6%), blood was
aspiration was needed as the blood rushed into the hub visible in the needle hub within less than 2 seconds after
during needle advancement. In the cases where no as- the initiation of the aspiration procedure, whereas in n = 3
piration was needed, injections were performed in the cases (1.4%) no aspiration was needed as the blood rushed
supraperiosteal plane of the pyriform fossa, the subdermal into the hub during needle advancement. The latter 3
plane of the pyriform fossa, and the subdermal plane of the cases were observed in the pyriform fossa (2×) and in the
nasolabial sulcus. nasolabial sulcus (1×). Utilizing the 213 positive cases evalu-
ated in this study, we may estimate the incidence rate to be
DISCUSSION in the range of 0.04% to 0.9% per pass (1 pass refers to 1
injection and 1 aspiration procedure per specific location).
This retrospective clinical study analyzed n = 213 cases The major strength of the study is that this is the first in
of soft tissue filler injections positive for blood aspiration vivo case series, to our knowledge, analyzing cases posi-
performed in Asian patients by the same doctor during a tive for pre-injection blood aspiration. Previous studies ana-
period of 48  months. The results revealed that the most lyzed influencing factors like pullback time,12 priming of the
Tseng et al 7

Table 5.  Review of Previous Studies Analyzing Product Type Injected, Needle Size/Length Utilized, Time Measured Until Blood
Visible in Needle Hub, and Pull-Back Volume
Study Present study Torbeck et al, 2019 Van Loghem et al, 2018 Casabona G, 2015 Carey et al, 2015

Downloaded from https://academic.oup.com/asj/advance-article-abstract/doi/10.1093/asj/sjaa075/5854116 by Uppsala Universitetsbibliotek user on 08 June 2020


Description In vivo In vitro In vitro In vitro In vitro
retrospective, case series using EDTA-coated using EDTA anticoagulated ink solution (saline + wa- slow pull test,
vacutainers blood bag pressurized ter-based red ink) in small cup using test tube heparinized
to 150 mmHg blood with rubber stopper

Procedures N = 213 clinical aspiration N = 20 experimental N = 340 experimental N = 30 experimental N = 153 experimental
performed aspiration aspiration aspiration aspiration

Gauge/ Secs mL Gauge/ Secs ML Gauge/ Secs mL Gauge/ Secs mL Gauge/ Secs mL
length length length length length

Restylane Lyft 27, ½”; <2 0.05-0.5 29, ½” 4; 0.2; 27, ½”; >10; 0.5 29, ½”; 29 Neg; N/A 29, ½”; <5 0.2; 0.3
(Perlane) 29, ½” 2 0.5 29, ½” 1-10 8 30, ½”

Restylane 27, ½”; <2 0.05-0.5 27, ½” 4; 0.2; 27, ½”; ~1 0.5 29, ½” 3 N/A 29, ½”; <5 0.2; 0.3
29, ½” 7 0.5 29, ½” 30, ½”

Restylane Vital 30, ½” <2 0.05-0.5 N/A N/A N/A N/A N/A N/A 30, ½” 2 N/A 29, ½”; <5 0.1; 0.05
30, ½”

Juvederm 27, ½” <2 0.05-0.5 27, ½” 2; 0.2; 27, ½” ~1 0.5 27, ½” 2 N/A 27, ½” <5 0.3
Voluma 2 0.5

Juvederm Volift 30, ½” <2 0.05-0.5 30, ½” 2; 0.2; 30, ½” ~1 0.5 30, ½” 1 N/A 30, ½” <5 0.2
2 0.5

Juvederm Ultra 27, ½” <2 0.05-0.5 27, ½” 11; 0.2; 27, ½” 1-10 0.5 27, ½”; 25 Neg; N/A 27, ½” <5 0.2
Plus 8 0.5 3

Belotero 27, ½” <2 0.05-0.5 27, ½” 30; 0.2; 27, ½” ~1 0.5 N/A N/A N/A N/A N/A N/A
Balance 23 0.5

Hyadermis Smile 27, ½” <2 0.05-0.5 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A

Elravie Deep Line 27, ½” <2 0.05-0.5 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A

Princess Volume 27, ½” <2 0.05-0.5 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A

Sculptra 25, ½”, 5/8” <2 0.05-0.5 N/A N/A N/A N/A N/A N/A 27 3 N/A N/A N/A N/A
1”,1.5”
24, 1”;
23,1”

Sunmax Collagen 27, ½” <2 0.05-0.5 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Implant

Artecoll 25, ½”; 26, ½” <2 0.05-0.5 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A

EDTA, ethylenediaminetetraacetic acid; mL, pullback volume; secs, aspiration time until blood was visible in the needle hub.

needle,11 or the pullback volume13 dependent on the type clinical real-life scenario. Another strength of the present
of product utilized.11-13 Despite their interesting diversity, all study is the large sample size, which was retrospectively
the referenced investigations employed an in vitro model evaluated during a 48-month period. This sample repre-
for their analyses, which lacks real-life conditions. These in sents the largest case series of positive blood aspirations
vitro models are absent of arterial blood pressure, which published to date. Another strength of this study is that
can influence the retrograde blood flow during the aspira- all analyzed cases were injected and reevaluated by the
tion procedure. Additionally, these models lack appropriate same investigator. This assures consistency during the in-
tissue temperature, which can influence the physiochem- jection process, the aspiration procedure, and the retro-
ical and rheological properties of the soft tissue filler and spective case analyses and their interpretation. However,
therefore increase the shear forces of the product inside this could also be regarded as a limitation of the study be-
the lumen of the needle at room temperature. Both factors cause no verification of the data by a second expert in-
can result in false lower aspiration rates compared with a jector occurred.
8 Aesthetic Surgery Journal

One weakness of the study is that only positive cases 30G 0.5-inch needle. Respecting product/needle combin-
for blood aspiration were analyzed. No detailed informa- ations could result in a reduced time until blood is visible in
tion on negative aspiration cases, the number of total in- the needle hub because a variety of products are known to
jection passes, or the precise amount of filler material have inadequate aspiration times even ex vivo. A reduced

Downloaded from https://academic.oup.com/asj/advance-article-abstract/doi/10.1093/asj/sjaa075/5854116 by Uppsala Universitetsbibliotek user on 08 June 2020


injected during the 48-month observational period was time until blood is visible will increase the clinical applica-
collected. This unfortunately excludes the identification bility because aspiration times longer than 2 to 4 seconds
of influencing factors by which the specificity of aspiration would lead to increased discomfort of the patient and of
procedures during soft tissue filler injections could be in- the treating physician. Additionally, longer aspiration times
creased. This also limits the statistical analyses to descrip- would increase false negative results due to potential
tive analyses only. The reported incidence rates are based needle tip movement or reposition with subsequently de-
on the estimation of the average utilization of filler material creased accuracy during injection procedures.
over several months and then extrapolation to 48 months. The differences between the presented results and
Weekly/monthly fluctuations in filler material utilization previous investigations (Table  5) could be caused by the
might influence the numbers employed for extrapolation different study setup because the aspiration procedures
and might thus influence the incidence rates presented. reported in this retrospective analysis relied exclusively on
The incidence rates presented could be additionally bi- clinical cases, whereas previous studies obtained their re-
ased by the preference of the injector, for example, selec- sults from an experimental study design. It is hoped that
tion of injection plane, needle type utilized, injection angle, the results of the present investigation show that aspira-
product type, or by regional/country-specific influencing tion can be performed with an acceptable aspiration time,
factors, for example, products being approved in some that is, less than 2 seconds, if a suitable product/needle
countries only. It could thus be possible that the “real” fre- combination is chosen. A larger needle diameter should be
quency of positive cases significantly differs compared chosen if a more viscous product is injected. A large pull-
with other injectors, with a non-Asian study population, or back volume, that is, >0.2 cc, could help to prevent false
with other centers. Future studies will need to validate the negative errors. However, a thorough understanding of fa-
numbers presented herein. To account for the limitations cial anatomy should be mandatory for each practitioner. It
inherited in this descriptive analysis (ie, selection bias), is important to understand the layered arrangement of fa-
no clear recommendations can be given. The study was cial structures and to be aware of facial danger zones and
designed and is presented as a retrospective descriptive especially of the variations in facial arterial vasculature.
analysis of in vivo positive aspiration cases. However, to
date this is the largest case series summarizing cases pos-
CONCLUSIONS
itive for blood aspiration. It is also the only systematically
analyzed series obtained in a clinical scenario as opposed The analysis of this retrospective case series of 213 posi-
to an experimental setting. tive blood aspiration procedures revealed that almost all
The results of this retrospective case series reveal that positive aspirations were evident within 2 seconds (1.4%
in all 213 cases (100%), blood was visible in the needle hub of the cases, blood rushed into the needle hub under its
within less than 2 seconds after the initiation of the aspi- own pressure). The pyriform fossa was the most frequent
ration procedure in contrast to other reports.11 This was in- location (n = 56; 26.3%), the most frequent depth was the
dependent of the type of product employed, the injected supra-periosteal plane (n = 195; 91.5%), and the most fre-
plane, the size of the needle utilized, or if the needle was quent needle utilized was a 27 G needle (n = 125; 58.7%).
primed. In 3 cases (1.4%), blood was visible even without The estimated incidence rate for a positive aspiration event
aspiration. These results are contradictory to currently per- ranged from 0.04% to 0.9% per pass. However, the results
formed standards where a minimum time of 4 seconds is are biased towards a preselected product/needle com-
recommended to aspirate before injecting the product. bination; this is in line with previous experimental studies.
One explanation why in 100% of the cases the aspiration Accurate relative risk assessment or causal relationships
time was less than 2 seconds could be the combination be- cannot be concluded from the data presented.
tween the injected product and the utilized needle.14 This
could be due to the preselection of the product/injector Disclosures
combination, which is supported by the results of previous The authors declared no potential conflicts of interest with
experimental investigations (Table 5, correspondence with respect to the research, authorship, and publication of this
at least 50% of the published literature): Juvederm Voluma article.
injected with a 27G 0.5-inch needle, Juvederm Volift in-
jected with a 30G 0.5-inch needle, Juvederm Ultra Plus in- Funding
jected with a 27G 0.5-inch needle, Restylane Lyft injected The authors received no financial support for the research,
with a 29G 0.5-inch needle, Restylane Vital injected with a authorship, and publication of this article.
Tseng et al 9

REFERENCES retrospective evaluations of 11 years of experience. Plast


Reconstr Surg. 2018;141(5):650e-662e.
1. The American Society for Aesthetic Plastic Surgery’s 8. Pavicic T, Yankova M, Schenck TL, et al. Subperiosteal in-
Cosmetic Surgery National Data Bank: Statistics 2018. jections during facial soft tissue filler injections-Is it pos-

Downloaded from https://academic.oup.com/asj/advance-article-abstract/doi/10.1093/asj/sjaa075/5854116 by Uppsala Universitetsbibliotek user on 08 June 2020


Aesthet Surg J. 2019;39(Suppl_4):1-27. sible? J Cosmet Dermatol. 2020;19(3):590-595.
2. Beleznay  K, Carruthers  JDA, Humphrey  S, Jones  D. 9. Cotofana S, Schenck TL, Trevidic P, et al. Midface: clinical
Avoiding and treating blindness from fillers. Dermatologic anatomy and regional approaches with injectable fillers.
Surg. 2015;41(10):1097-1117. Plast Reconstr Surg. 2015;136(5 Suppl):219S-234S.
3. Chatrath  V, Banerjee  PS, Goodman  GJ, Rahman  E. Soft-
10. van  Loghem  JAJ, Humzah  D, Kerscher  M. Cannula
tissue filler-associated blindness: a systematic review of versus sharp needle for placement of soft tissue
case reports and case series. Plast Reconstr Surg Glob fillers: an observational cadaver study. Aesthet Surg J.
Open. 2019;7(4):e2173. 2017;38(1):73-88.
4. Cotofana  S, Lachman  N. Arteries of the face and their 11. Carey W, Weinkle S. Retraction of the plunger on a syringe
relevance for minimally invasive facial procedures: an of hyaluronic acid before injection: are we safe? Dermatol
anatomical review. Plast Reconstr Surg. 2019;143(2): Surg. 2015;41(Suppl 1):S340-S346.
416-426. 12. Van  Loghem  JA, Fouché  JJ, Thuis  J. Sensitivity of aspir-
5. Pavicic T, Webb KL, Frank K, Gotkin RH, Tamura B, Cotofana S. ation as a safety test before injection of soft tissue fillers.
Arterial wall penetration forces in needles versus cannulas. J Cosmet Dermatol. 2018;17(1):39-46.
Plast Reconstr Surg. 2019;143(3):504e-512e. 13. Torbeck RL, Schwarcz R, Hazan E, Wang JV, Farberg AS,
6. Pavicic  T, Frank  K, Erlbacher  K, et  al. Precision in Khorasani H. In vitro evaluation of preinjection aspiration
dermal filling: a comparison between needle and can- for hyaluronic fillers as a safety checkpoint. Dermatol
nula when using soft tissue fillers. J Drugs Dermatol. Surg. 2019;45(7):954-958.
2017;16(9):866-872. 14. Casabona  G. Blood aspiration test for cosmetic fillers
7. Frank  K, Koban  K, Targosinski  S, et  al. The anatomy be- to prevent accidental intravascular injection in the face.
hind adverse events in hand volumizing procedures: Dermatol Surg. 2015;41(7):841–847.

You might also like