Brava for professionals

CLINICA TRIALS RESULTS - GROWTH

Brava, LLC has conducted two clinical trials. The Lead Clinical Investigator for these trials was the world-renowned plastic & reconstructive surgeon, Dr. Thomas J. Baker. Results of the initial study were published in the journal of Plastic & Reconstructive Surgery, June 2000.

An overview of each is provided.

Clinical Trial 1998-1

The results of the initial clinical trial were published in the journal of Plastic & Reconstructive Surgery and later presented to the U.S. Food & Drug Administration. Seventeen healthy women participated and 12 completed the protocol. Five subjects were dismissed from the study due to their failure to follow the required protocol. Each participant was asked to adhere to a daily 10-hour application of the device over a 10-week period; this resulted in an average breast growth of 104cc as measured 15 months after termination of treatment. As illustrated in the Brava Action Graph below, participants saw a progressive increase in their breasts and at 10 effective weeks of treatment reached their peak size. They were then instructed to remove the System and were re-measured four weeks later. Final growth averaged 104cc.

NOTE: For the sake of clarity 100cc is roughly equivalent to 1 bra-cup size.

                                                                           Brava Action Graph

Peak Growth. After completing the effective 10-week treatment (14.7 average weeks of wear), Brava participants experienced an average volume increase of 161cc per breast, which included both true tissue growth and edema (swelling) (Results ranged from 114-196cc depending on the individual wear pattern of the device.)

Relative-size Increase. Participants' initial breast size (baseline) ranged from 96cc to 282cc. After completing the 10-week effective treatment, the average increase in volume, at peak, was 100% (% increase ranged from 29% to 300%) from baseline.

Final Growth. Final growth was measured four weeks after discontinuing use of the device. The participants had decreased from their peak growth as the edema (swelling) dissipated. This left them with an average final volume increase of 104cc (with a range of 34-158cc of growth). This represents approximately a 50% increase in breast size from their initial breast size (baseline). This average of 104cc correlates to an increase of approximately 1 cup size for all subjects.

Participant's chest circumference measurements were taken at the nipple and at the inframammary fold (the crease under the breast) before and after treatment. Measurements taken at Final Growth showed an average volume increase of 65%, which remained on long-term follow-up.

(Subsequent to the publication of these results and approximately 22 months after stopped wearing the device, participants were measured. It was found that participants maintained 95% of the growth that they had experienced approximately 4-weeks after they had stopped wearing the system.)

Satisfaction. All participants in the study were satisfied with the results. Participants believed that their breasts had not only increased in volume but had also been lifted to some extent. All felt more comfortable with their body image and 100% indicated they would recommend the product to a friend. The before and after responses noted on the Satisfaction Questionnaire were highly significant for increased satisfaction in self-esteem.

Conclusion. After reviewing the system, the U.S. Food and Drug Administration (FDA) has classified the system as a 510(k) Class I Exempt Device, allowing the sale of the BRAVA System. The system has met all FDA marketing requirements.

Clinical Trial 2001-1

The second clinical trial enrolled 125 women at 6 clinical research centers in four major U.S. cities. This study was undertaken to demonstrate safety and efficacy in a larger patient population and to test product improvements. Each was asked to wear the system everyday, for at least 10 or more hours per day and for at least 10 consecutive weeks. Bead displacement measurement of breast volume and photo-documentation were done before, throughout the study, and upon study termination. Final recordings were obtained at least one month after cessation of treatment only after unchanged breast volume measurements two weeks apart confirmed stable enlargement. Results were correlated with demographic and physical factors, with duration of treatment and with daily compliance as recorded by the microchip in the device.

95 of the 125 enrolled participants completed the study. The reasons for withdrawal were: inability to comply with the required hours of wear (n=24), refractory dermatitis (n=3), and greater than 5% body weight change (n=3). The majority of non-compliance withdrawals occurred within two weeks of initiating treatment. The 95 participants were asked to discontinue use at an effective 10-weeks of treatment were measured for final results at week 13-14. Many chose to wear the System for an additional cycle in the hopes of obtaining additional breast growth; all did receive additional growth in the second cycle. The average wear for all participants was 13.5 weeks and the average daily wear as 11 hours per day.

Final Results: Measurements were taken two weeks apart one month after cessation of treatment. Ninety-five women completed at least 10 weeks of treatment. The average wear was 13.5 weeks (range of use 10-26 weeks). At the end of the treatment, some of the volume gain gained was edema and after the breast increase stabilized, the final results mirrored the results from the initial study with a slightly higher average of 108 cc (final growth ranged from 30 cc to 250 cc).

The growth represented an average 80% increase in breast size (ranging from 11% to 290%). Fourteen women achieved an excellent outcome as their breast volume more than doubled and had an absolute volume gain greater than 120 cc; 43 achieved a very good result with greater than 50% increase over initial breast size and net volume gain greater than 100 cc; 27 achieved a good result, greater than 50% increase over initial breast size and net volume gain greater than 80 cc; only 11 had a marginal outcome, less than 50% increase over initial breast size and net volume gain less than 80 cc.

Parity, body fat content and initial breast size had a minor positive effect that was not statistically significant, but what was most significant in determining breast growth was the intensity (hours worn per day) and duration of treatment (weeks of use).

Conclusion. This study confirms that external tissue expansion of the breast with BRAVA leads to larger fuller breasts. Like other expansion procedures used in medicine, true tissue growth is slow and requires sustained tension. Daily intensive compliance and overall duration of treatment are the main predictors of positive outcome. This non-invasive tissue-engineering alternative makes it possible for women to increase their breast size at the rate of 1-1.5 cc per day. The more the system is worn, the more breast tissue results.

                                                                                                              Before                                                              After

                                                                           

 

 

COSMETIC

 

 

 

BravaandAutologous  FatTransferIsaSafeand EffectiveBreastAugmentationAlternative:Resultsof a6-Year,81-Patient,  Prospective  MulticenterStudy

 


Roger  K.Khouri,  M.D. MaritaEisenmann-Klein,M.D. EufemianoCardoso,  M.D. Brian  C.Cooley,Ph.D. Daniel  Kacher,  M.S.

EvaGombos,  M.D. Thomas  J.Baker,M.D.

 

KeyBiscayneandMiami,Fla.; Regensburg,Germany;Milwaukee, Wis.;andBoston,Mass.


 

Background:Breast  augmentationbyautologousfattransferisan  appealing alternativeinneed  ofscientific  validation.

Methods:  Inaprospectivemulticenterstudy,81women  (age  range,  17to63 years)woretheBravadevice,abra-likevacuum-based  externaltissueexpander, for4weeksandthen  underwentautologousfatinjectionusing10to14needle puncturesitesintoeachbreastinathree-dimensionalfanningpattern(average,

277mlvolumeinjectedperbreast).PatientsresumedBravawearwithin24hours for7ormoredays.Pretreatmentandposttreatmentbreastvolumeswerederived from  three-dimensionalvolumetricreconstructionofmagneticresonanceim- aging  scans,and  outcomeswerecomparedwithameta-analysis  ofsixrecent publishedreportsonautologousfattransferbreast  augmentationwithout  ex- pansion.Follow-uprangedfrom  12monthsto6years(average,  3.7years). Results:Breastvolume  wasunchangedbetween  3and  6months.Seventy-one ofthe  treatedwomen  werecompliantwithBravawearand  had  amean  aug- mentationvolumeat12monthsof233mlperbreastcomparedwith134mlper breastinpublishedserieswithoutBrava(p  0.00001).Graftsurvivalwas82 

18percentcomparedwith55    18percentwithoutBrava(p   0.00001).There wasastronglinearcorrelation(R2    0.87)betweenpregraftingBravaexpansion andtheresultantbreastaugmentation.Therewerenosuspiciousbreastmasses ornodules.Magnetic  resonanceimaging  recognizeda16percentincidenceof fatnecrosis  easilyidentifiedat1-yearmammographicevaluation.

 

 

 
Conclusion:  TheadditionofBrava expansionbeforeautologousfatgraftingleads tosignificantlylargerbreastaugmentations,withmore  fatgraftplacement,higher graft  survivalrates,  and  minimal  graft  necrosis  orcomplications,demonstrating highsafetyandefficacyfortheprocedure.   (Plast.Reconstr.Surg.129: 1173,2012.)

CLINICALQUESTION/LEVELOFEVIDENCE:  Therapeutic,IV.


 

 


utologousfattransferto  the  breast  has  a longandcontroversial history.1,2In1987,a positionstatementbytheAmericanSocietyof

3


cancer  withthexeromammographictechnologyof thetime.However,radiologiststodayarebetterable to   differentiate   neoplastic   processes    from    fat


 

A

 
PlasticSurgeons

bannedtheprocedureoutofcon-


necrosis.4–6Furthermore,becauseofmanytechnical


cernthatthegraftswouldnotsurviveandcouldlead

tocalcificationbelievedtobeindistinguishablefrom

 

 

FromtheDivisionofPlasticSurgery,FloridaInternational University;theMiamiBreastCenter;Klinikfu¨rPlastische und  A¨sthetische  Hand-  und  Wiederherstellungschirurgie, Caritas-KrankenhausSt.Josef;Orthopaedic  Surgery,  Med- icalCollegeofWisconsin;SurgicalPlanningLaboratoryand RadiologyBreastImaging,BrighamandWomen’sHospital, HarvardMedicalSchool;andtheDepartmentofSurgery, UniversityofMiami.

ReceivedforpublicationAugust23,2011;acceptedNovem- ber29,2011.

PreliminarystudyresultspresentedattheAnnualCongressof theAmerican  SocietyforAestheticPlasticSurgery,inOrlando, Florida,May21through25,2006;interimresultspresented


refinements,7,8  autologousfattransfertoday  holds

 

attheAnnual  Congress  oftheAmericanSociety  ofPlastic

Surgeons,inSeattle,Washington,October23through27,

2009.

Copyright©2012bytheAmerican  SocietyofPlasticSurgeons

DOI:10.1097/PRS.0b013e31824a2db6

 

 

 

Disclosure:Dr.Khourihasanequityinterestin Brava,LLC,themanufactureroftheBrava device, and  isan  ownerofthecompany thatmakesthe Lipografter  describedinthearticle.Theotherau- thorshavenofinancialintereststodisclose.


www.PRSJournal.com                                                     1173


Plastic  and   Reconstructive     Surgery   May2012

 

 


much  promise  inplasticsurgery.9 –24  Therefore,in

2007,theAmericanSocietyofPlasticSurgeonscom- missionedaFatGraftTaskForcethatconcludedthat autologousfattransfermightbeusedforthebreast “whilethetechniquesandtheresultsvary.. ..leaving atremendousneed  forhigh  qualityclinical studies.”25  In2009,the  American  SocietyofPlastic Surgeons  lifted  the  ban  on  fatgrafting  forbreast reconstructionwhilerecommending cautious  use for  augmentation26  because  ofconcernfor  safety and  efficacy,giventhepaucityofscientificstudies.

Breastaugmentation withliposuctionedfathas suffered  fromtwofundamentallimitations:thevol- umeoffatthatcanbetransferredinasinglesession andthepercentagegraftsurvival.18–22,27  Infact,there seemstobeaninverserelationshipbetweenthetwo (i.e.,  the  more   fat  grafted,   the  lower  itssurvival rate).28Effortsatovercoming thishavefocused  on harvesting  techniques, fatmanipulation,stemcells, and  relatedapproaches.13,17–20,23,24,27,29–72  Moststud- iesreport50to60percentsurvivalandanaugmen- tation     in    the    100-ml    range     on    long-term follow-up.17–22,27Ofnote,nonemadeanyattemptto improve  thequalityoftherecipientbreast.

To  preserve   the   graft-to-recipientinterface criticalforrevascularizationandsurvival,fatgrafts havetobedispersedas microdroplets.Becausein the  smallbreasts  tobeaugmentedthereisphys- icallyno  room  for  dispersal  without  crowding  a largequantityofmicrodroplets,wepostulatedthat preparationof  the  recipientbreast  byexternal expansionisthe  keymissingingredient.

TheBravadevicehasbeen  onthemarket for over10yearsasanexternal soft-tissueexpander and  has  demonstratedmodest,  permanent  aug- mentationafterlong-termuse.73–77Short-termuse of  Brava,  however,  causes  a  markedtemporary increase  inbreast  sizeand  generatesavery large fibrovascularscaffoldthatwouldbe anidealre- cipient  forfatgrafts(KhouriRK,personalobser- vation).  Weundertook thismulticenter,prospec- tive,  magneticresonanceimaging–documented study  to  determinethe  safety  and  efficacy  of single-stage  large-volume  autologousfat  trans- fertothebreast  treatedwiththeBravaexternal breast  expander.

 

PATIENTSANDMETHODS

Thisstudywasdesignedtooptimize  allpoten- tial  variables.  This  includes   low-pressure  atrau- maticfatharvest,minimalgraftmanipulation,and meticulous  microdroplet   grafting.    Because   a larger  recipienthasroom  inwhichtosafely graft larger  volumesand  because  itiswell proven  that Bravaexpansionenlarges  therecipientbreast,we


founditunethicalto  randomizeBravapatients versusnonexpandedcontrols  andarbitrarily  con- demnwomentothemorbidityandrisksofsurgery for  alesseffective  procedure.  Furthermore,  be- causethere aremultiplerecentpeer-reviewed  re- ports  ofautologousfattransferbreast  augmenta- tion  without  expansion,weelectedto  compare our  Brava-expandedcohorttoameta-analysisof thiswell-established  baseline.

On  institutionalreviewboard  approval  (Con- cordia  ClinicalResearch,  Inc.;BreastReconstruc- tionandAugmentationwithBravaEnhancedAu- tologous  FatMicroGrafting  Protocol No.2004-2, IRBCOMM.No.167),81women  (Miami  Breast Center,Key Biscayne,Fla.,n     59;Caritas-Kran- kenhaus St.Josef,Regensburg,Germany,  n    12; Harley  Medical  Center,London,  United  King- dom,  n     10)whodesired  breast  augmentation, wereaversetoimplants,  and  whotolerateda20- minuteBravatesttrialintheofficewereenrolled inthestudy.Weperformed77bilateral  and  four unilateralautologousfattransferbreast  augmen- tationson170breasts.Patientagesrangedfrom17 to63yearsand  bodymassindex  rangedfrom  15 to28(average,  19.8).Smokerswereexcluded.All enrolledwere  grafted  despite  wide  variation  in compliance  with  the   requested  pregraft  Brava

treatment1and  despite  thefactthat  fourpatients werenoncompliant.Sixpatientsdidnotreturnfor follow-up  magneticresonanceimaging,  and  al- thoughself-reports  indicatethey  are  complica- tion-free,  postprocedurebreast  volumetricmea- surements  were  not   taken.   Six  of  the   earlier patientslater  underwentgrafting  asecond  time. However,weonlyanalyzed  the  outcomeoftheir firstgraft.  Figure  1showsthe  breakdownofthe treatedand  compliantpatientgroups.

BeforeBrava expansionandinphasewithher menstrualcycle,everywomanunderwentbaseline magneticresonanceimaging  withbreastcoils,in- travenousgadoliniumcontrast,and  fat  subtrac- tion.  The  patientswereasked  towearthe  Brava externalbreast  tissueexpanderfor10hours/day for4weeks. Thispreexpansionperiodincreases the  vascularityofthe  recipientsite.61,62,78Forthe last36to48hours,  theywereasked  tomaintain uninterruptedexpansionand  come  tothe  oper- ating  room  stillwearing  the  expander,toinduce animmediate temporary three-dimensionalen- hancedenlargementofthe  subcutaneous  perig- landulartissuematrix  (Fig.2).

Harvestingand  grafting  wereperformedwith the  Lipografter,aclosed  fatharvesting,process- ing,and  grafting  device(KVAC Syringeand  A-T Valve;Lipocosm,  LLC,Miami,Fla.).  The  fatwas


 

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Fig.1.  Studydesignflowchart,showingsequenceofmagneticres- onanceimaging(MRI)scans,withbreakdownofnumbers  basedon follow-up(FU)andBravausecompliance.

 

 

 


aspiratedwitha12-hole,2.7-mmcannula(Marina Medical,  Sunrise,  Fla.)  attachedtoaspring-acti- vatedKVACsyringepullinga constant300-mmHg vacuum.   The   aspirate   was  transferred  directly from  the  syringe  to  acollectionbag  through  a noncloggingthree-way  A-TValveand  the  bags werecentrifugedat15gfor  3minutes.The  su- pernatantfatwasthenreinjecteddirectlyfromthe bagusingtheA-TValveinreverseusing3-to5-ml syringesand  2.4-mmsingle-sideholeblunt  15-to

25-cmreinjectioncannulas.Wegrafted  thebreast through amultitudeofperimammaryand  peri- areolar needlepuncturesites,injectingnomore than  1ml  per  5cm  of  cannularetraction,mi- croweaving  the  graftsand  fanningthe  passesra- diallyaroundeach  injectionsite.Adequatepre- expansionallowedustolayerthe  graftsinthree planes,theimmediatesubdermal,thedeepermas- tectomylevel,and  anintermediatesubcutaneous plane.  Weavoided  the  peau  d’orangeeffect  of subcutaneousoverfilling.  Wethen  proceeded to graftthesubglandulartissue,thepectoralmuscle, and  the  subpectoralplane,  strictlyavoiding  the breastparenchyma.Wecarefullyavoidedlocalized collectionsand  overgraftingasassessedbytissue turgor.A supportive conformingbreast  bandage wasappliedatthe  end  ofthe  procedure.


Within24hours  aftertheprocedure,patients removedalldressings,tookashower,andworethe Bravadeviceforthenext  48to72hours  uninter- ruptedtohold  upthe  graftsasstents  duringthe revascularizationand  early  engraftmentperiod. Onthethird  postoperativeday,theywereencour- agedtoreturntotheirnormallifestyleandtowear theBravadeviceonlyatnight  for4more  days.If Bravausewaswell-tolerated,  theycontinuedwear- ingitafewhours  perday,tapering thewearover anadditionalfewweeks.Patients  wereseen  ona quarterlybasisforthefirstyearand  then  onlyon anas-neededbasis.Finalfollow-upwasbymeans ofelectronicmailortelephone.At3 months after grafting,  asecond  magnetic resonanceimaging scanwasobtainedonthefirst24patients, andall underwentfinalmagneticresonanceimaging  at6 to12months.Allwomen  older  than  40yearsun- derwentmammography at1yearcomplemented byanultrasoundexaminationwheneverindicated by  the  radiologist.  Two  independentteams  of breast   radiologists   reviewed  the   mammograms and  magneticresonanceimaging  scans.

Baseline  and   final  breast   volume  measure- mentswerederivedfrommagneticresonanceim- aging  scansviewedin  axialorientationwiththe DigitalImagingandCommunicationsinMedicine


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Fig.2.  Magneticresonanceimagingscansofbreastswithcon- trastinapatientbefore(above)andafter3weeksof10hours/day ofBravause(below).Notetheenlarged  parenchymaandthe marked  increased  vascularityinthe  image  below(afterBrava use).

 

 

 

standard.Thebreastareawasoutlinedforsections at1-mmintervals,  includingthe  skinand  basing theinternal margin  onconsistentanatomical landmarks(e.g.,  sternum,pectoralis,shoulder features).Areasweresummed toyieldavolume approximationforeachbreast,measured in milliliters.79  Maximal  expansionvolume  wasde-


Dataextractedfromsixrecentlypublishedclinical studies,18 –23  which  did  not  useexpansionbefore autologousfattransfer,werecombinedandused as   a   control   group   (total   sample   size,   n    

335).80–82   Of  these,   four  (n    280)  reported autologousfattransferaugmentationusing  var- iousmeans  ofharvesting  andfatseparation,18,20,21,23 andtwo(n   55)usedstemcellenhancedtech- nology   (which   involves  the   addition  of  pro- cessedfatand  concentratedstemcells).19,22  Ta- ble  1showsthe  graft  retentionrates  based  on outcomesfrom  these  studies,  withamean  graft retentionrate  of55percent.The  data  for  our series  were  comparedusing  pairedttests(be- foretreatment versusaftertreatment). Forcom- parison  ofthe  percentageaugmentationwiththe previouslypublishedpooledcontrolgroup,weused atwo-sampleindependent-variancettest.

In  additionto  the  comparisonofthe  mean retentionrate  and  augmentationvolumes  ofthe publishedautologousfattransfercontrolandour autologousfattransferplusBrava–treatedgroups, adose-responsecurvewas developedtomeasure the  effect  ofpreexpansionon  fatvolume  trans- ferred,using  apaired  ttest.Allenrolledwomen wereaskedtousetheBravadevicefor10hours/ dayfor4weeks.However,someweremore  com- pliant  than  others;  and  some,  withinvolutional atrophy,   had  tissues  that  were  more   compliant than   the   younger,   tighter  nulliparous  breasts. Thus,  weobserved   a  markedvariability  in  the amountofpregraftbreastexpansionthatallowed usto  build  adose-responsecurve  ofexpansion versusaugmentation.

To  furtheranalyze  the  relationshipbetween expansionand  augmentation,aregressionanaly- siswasperformedonthesampleof75women.The

 

 

 

Table1.  AnalysisofSixPublishedArticlesUsing

AutologousFatTransferwithoutExpansion


rivedphotographicallybycomparingthestandard setofthreeposesobtainedatthetimeofmaximal expansiononthedayofsurgerywithtwoothersets


 

Reference

Zocchiand


 

Sample

Size       Mean    SEM*


 

Lower

Limit


 

Upper

Limit


oftheexactsamethreeposestakenatthebaseline

andatthefinalbreastvolumemeasurements,both withknownmagneticresonanceimaging–derived measurements.The  injectedgraft  volumes  were recordedduringthe  procedure.

Statisticalanalysiswasperformedonthreeend- points:  augmentationvolume,  definedasfinal  baseline  breast  volumemeasurement;percentage augmentation, definedas[augmentationvolume/ baseline]     100;andgraftsurvivalrate,defined as [augmentationvolume/injectedgraftvolume]  100.


Zuliani,  200820           181       0.5500   0.016      0.519     0.581

Wangetal.,

200818                                       33       0.4900   0.003      0.484     0.496

Yoshimura

etal.,200819                     40       0.5500   0.041      0.467     0.633

Delayetal.,

200921                                       30       0.6500   0.013      0.624     0.676

 

eberreiter

etal.,201023

36

0.5168

0.020

0.477

0.557

otal

335

0.5528

0.0281

0.495

0.611

 

 
Yoshimura

etal.,201022                     15       0.5600   0.076      0.397     0.723

U

 

T

*SamplevarianceusedtocomputetheSEMwascalculatedfromdata providedinthe  study.


 

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datawerenormalizedbydividingbothvariablesby baselinevolume.Maximal expansion/baseline volumewasusedastheindependentvariableand augmentation/baselinevolume  was used  asthe dependentvariable.Descriptivestatisticswerecal- culated  andtheir  relationship analyzedusing MATLAB 7.8.0(MathWorks,Natick,  Mass.)and the  function“cftool.”

 

RESULTS

Ofthe84womenevaluatedforenrollmentin thestudy,three(3.6percent)wereturnedawayfor failuretopasstheBravatolerancetestintheoffice. Weprogressivelyincreasedgraftvolumeaswebe- camemore  comfortablewiththeprocedure. The first20 womenweregraftedconservativelywithan averageof190mlperbreast,  resulting in90per- cent   graft  survival,  whereas  the  latest  20  were grafted  an  average  of360mlper  breast  with78 percentmeasuredgraft  survival.Operatingtime forthe  first20casesaveraged  4hours  and  later decreasedto2hours  despite  largervolumesaswe developedthe  Lipograftertoincrease  harvesting and  grafting  proficiency.  There werenosurgery- relatedcomplications.Averagefollow-upwas3.7 years(range, 12to75months).Except  fortem- porary  bruising  and  superficial  skinblisters  that healed  uneventfully, there  were  no  significant complications,and  allwomenreturnedtoseden- taryactivitieswithin3to4daysand  fullactivities within1week,withtheliposuctioneddonorsites asthe  onlyfociofmorbidity.  One  patientdevel- oped  alate  (2  months  postoperatively)atypical mycobacterialinfectiontreatedsuccessfullywith oralantibioticsandminor incision  anddrainage. Sixwomen  had  unplannedpregnancieswithin6 monthsafter  grafting.  Allhad  normaldeliveries andbreastfed.Follow-upmagneticresonanceim- aging   scans   were   obtained  1  year  after   they stoppedbreast-feeding.None  ofthe  patientsde- velopedclinically suspiciousbreastmassesornod- ules.  Althoughsome  women  had  minor  weight fluctuationsduringthe  course  ofthe  study,  the overallaverage  bodymassindex  didnot  change. Allwereverypleased  withthe  enlargementand improved appearanceoftheir  breasts  and  lipo- suctioneddonorsites(Figs.3through5).

The  3-and  6-monthmagneticresonanceim- agingscanswereessentiallyunchanged(p    0.4, paired  ttest),  indicatingthat  whatever  graft  sur- vivedat3monthswas stable.  Therewererecog- nizablefocioffatnecrosisin12ofthe75women. At1 year,onlythesesame12women(16percent) showedsomecalcificationsonmammography.All calcifications  wereclearlyrecognizableasbenign


fatnecroticfoci.Becausetheyweredeterminedto benotsuspiciousformalignancy,theyrequiredno furtherintervention.Everyfocus  offatnecrosis identifiedbymagneticresonanceimagingwasalso recognizedasabenignoilcystbymammography, confirming thatinthisseries,the1-yearmammo- gram  was assensitiveasmagneticresonanceim- aging  for  the  detectionoffatnecrosis.  Because therewasnochangebetween  the3-and6-month magneticresonance  imaging   scans,  the   subse- quently  enrolled47women  had  only  one  mag- netic   resonance  imaging   scan   at  a  minimum

6-monthfollow-up(average,  1year).  One  ofthe

6-monthfollow-up  magneticresonanceimaging scanswasread  asequivocal,  requiringarepeated study6monthslater  that  confirmedthe  benign natureofthe  lesion.

Table2listssummarybreastvolumetricdataof the  71Brava-compliant autologousfattransfer– treatedpatients.Theaveragevolumeoffatgrafted was282ml  per  breast,  witharesultantaverage augmentationof233mlper  breast  (range,60to

619ml;SD,108mlper  breast).Table  3summa- rizesthepublishedautologousfattransferbreast augmentationcontrolseries.Basedon  the  avail- able  data  (n    124),  the  mean   volume  of  fat grafted  was249  ml  per  breast,  with  aresultant weightedaveragevolumeaugmentationof134ml perbreast(range,63to223mlperbreast;SD, 43 mlperbreast).Statisticalcomparisonofaugmen- tation  volumes  achieved  withBravaplus  autolo- gousfattransferissignificantly  greaterthan  the publishedseries  ofautologousfat  transfer  aug- mentations(p    0.00001,  two-sample  indepen- dent-variancettest).

Theweightedmeangraftretentionrateofthe publishedcontrolpatients(n    335)was55per- cent,  withaweighted  SDof18percent.In  our treated patients(n   75),themeangraftretention rate  was78percent(range,0to  129  percent). However,themean  retentionrateforthetreated compliantsample(n   71)was82percent(range,

40to129percent;SD,18percent)(p    0.00001, two-sampleindependent-variancettest).

Adose-responsecurveillustratingtherelation- shipbetween  pregraftingBravaexpansion(dose) andfinalbreastaugmentation(response)wasde- veloped.  The  expansionand  augmentationdata werenormalizedbydividingeachvariablebybase- linevolume,  creatingaratio  plottedinFigure  6.

The  correlationofdetermination(R2)between thetwowasinitiallyderived  usingthelinear  least squares  method.However,because  there aresev- eraloutliers  inthedatathatweighheavilyonthe fit,weused  the  “robust  fit”3  method,which  de-


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Fig.3.  Imagesofawomanwithpectusdeformityandasymmetry(above),showingmaximalexpansionjustbeforefat graftingwiththemarkingsoftheinjectionsites(center).Pectusandasymmetryhavebeencorrectedandstableaug- mentationhasbeenachievedat2.5-yearfollow-up(below).

 

 

 

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Fig.4.  A24-year-oldAsiannulliparouswomanisshownbeforeexpansion(above,left)andaftermaximalpregraftingexpansionwith markingsofneedle  puncturesitesforthegraftingcannulae  (above,center).Herappearanceafteraugmentationresultat1-year follow-up(above,right).(Below,left)Preoperative  and(below,right)postoperativemagnetic  resonanceimagingscans;notethe periglandularfatgraft.Volumetricthree-dimensionalreconstructiondocumented260mlofaugmentationperbreast.

 

 


emphasizesoutliers  toachieve  an  alternativefit. Figure  6showsthe  robust  fitted  curveand  itsre- spectiveconfidenceinterval  boundaries.

Figure7 illustrates  thecorrelationbetween preoperativeBravaexpansionand  augmentation volume.Wesubdividedthepatients intofour groups  depending ontheir  expansionratio. Women  whowerenotcompliantandwerepoorly expanded could  beconsideredasnonexpanded controls.Theyendedup  withaugmentationvol- umescomparabletothepublishedautologousfat transfer series,whereasthosewhodoubledortri- pled  their  baseline  volume  asaresult  ofBrava expansionachieved  augmentationvolumes  com- parabletomoderatesizedimplants.

 

DISCUSSION

Fatgrafting  isanestablishedprocedureforthe facewhereverysmallvolumesaregraftedinahighly vascularrecipientsite.32–36,46,50 –52,8385   Itisalsowell acceptedforthebuttocks,  wherelargervolumesare grafted  inalargerecipient siteandwherecalcifica- tions  and  nodulesare  lessworrisome.48,86 88   How- ever,fatgraftingtothebreasthasremainedcontro- versialfor  twomain  reasons:  (1)  our  inability  to transferlarge  volumes  offatin  asmall  recipient breast  and  predictablyexpect  ahigh  graftsurvival rate,  and  (2)  our  perceivedinabilitytodistinguish


graftfailurenodulesandcalcificationsfromcancer. The   inability   to   optimize   these   outcomes  has spurredagreat  deal  ofinterestand  experimenta- tion.Our  datashowthatexternalexpansionofthe recipientbreastwithBravabeforeandafterthepro- cedureenablesthephysiciantoachieveanincrease involumeandgraftsurvivalsignificantlysuperiorto whatcanbeachieved  without  it.Statisticalanalysis showsthattheextentofpreoperativeexpansionisa major  determinantoffinalaugmentationvolume.

Pregraftingexpansion  creates   a  larger   and more  fertile  recipientmatrix  thatwillallowmore fatgraft  dropletsto  be  diffuselydispersed,  with eachmaintainingthecrucialgraft-to-recipientin- terface  contact  requiredforrevascularization.71A numberofsurgeonshaveshownacceptableresults using  avarietyoffatharvesting  and  preparation methods,some  often   diametricallyoppositeto

each  other.29,31,40,41,43,45,49,54,89–114   Interestingly,the

controlstudiesreviewedinthisarticleusedvarious graft  preparationmethods,includingstem  cell– enrichedfattoyieldsimilar  results.  Our  experi- encepointstothefactthattherate-limitingfactor inlarge-volume  autologousfattransferisthe  re- cipient  site,notthegraftmaterial anditsharvest- ingand  preparation.

Large-volume  autologous fattransfer isthree- dimensionalgrafting,  anovel  conceptrequiring


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Fig.5.  A31-year-oldnulliparouswomanisshownbeforetreatment(left)andat6-month(center)and5-yearfollow-up(right).Breasts aresoft,withnomasses,andstableaugmentation.

 

 

Table2.  MagneticResonanceImagingAnalysisandVolumetricStatisticsof71Treated

Brava-CompliantPatients*

 

 

Statistic

Baseline

Volume(ml)

MaximumExpansion

Volume(ml)

Grafted

Volume(ml)

Final

Volume(ml)

Augmentation

Volume(ml)

Expansion

Volume(ml)

Minimum

85

250

90

200

60

70

Maximum

1015

1290

600

1230

619

741

Mean

371

678

282

605

233

306

SD

173

236

112

223

108

130

*Greaterthan  20percentexpansion.

 

 

 


conceptualthinkingakin  to  sowing  seeds  in  a field.Toyieldthebestcrop,  weneed  tooptimize the  followingfour  componentsaligned  inseries suchthat  each  canberate  limiting:

 

 

Theseeds(e.g.,thegraft,itsquality,viability,fat inductive  ability).

The  plantingmethod(e.g.,  the  surgical  tech- niqueof diffusely,evenlyandatraumatically sowingtoavoidclumps,  collections).

The  field(e.g.,  the  recipienttissue,itssize,its vascularity,the  presenceorabsence  ofgrowth promotingfactors).


The  nurturingofthe  seedlings  after  planting (e.g.,postoperative care,immobilization, stim- ulationofgrowth).

 

Ifonlyone  oftheabovecomponentsispoor, evenifallothersaremaximized,thefinalyield will be  poor.  It  isthe  least  optimizedofthese  four components, thebottleneck factor,whichbe- comestherate-limitingstepand  theone  that  de- terminesthe  overallresult.

Beforeseeding,thefarmerpreparesthelandtoaccept theseedsbyplowing  andtillingthesoil.Bravaworksin asimilarway.Whenthedeviceiswornbefore  the procedure,it  preexpandsthe  recipient  matrix,


 

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Table3.  ControlGroupData

 

Reference

Treatment

No.

Grafted*(ml)

Augmented†(ml)

GraftSurvivalRate‡(%)

SD§(%)

Zocchiand  Zuliani,  200820

AFT

181

55.00

21

Wangetal.,200818

AFT

33

275

129

49.48

2

Yoshimura  etal.,200819

CAL¶

40

273

150

55.01

26

Delayetal.,200921

AFT

30

65.00

7

Yoshimura  etal.,201022

CAL¶

15

264

149

56.55

29

Ueberreiteretal.,201023

AFT

36

184

110

51.68

12

Total                                                                   335                                               134                                   55

AFT,autologousfattransfer;  CAL,cell-assistedlipotransfer.

*“Grafted”involvesthe  additionofprocessedfatand  concentratedstemcells.The  volume(ml)  offatinjectedinto  the  breast  areaislisted. The  sample  (n    124)isthe  sumofthe  sample  sizesinthe  studies  byWangetal.,18  Ueberrieteretal.,23  Yoshimura  etal.,19  and  Yoshimura etal.22Wangetal.’scalculationsarethesumoffiveseparategraftingproceduresofbetween50and60ml/session,conducted1monthapart.18

The  articles  byDelayetal.21  and  Zocchiand  Zuliani20  donot  provide  injectedvolume  data.

†Growth(in  milliliters)forthe  articlesbyWangetal.18  and  Yoshimuraetal.19  wascomputedfrom  availabledata.  The  article  byYoshimura etal.22  explicitlyprovidedthe  growth  datafigures.Therewerenovolumedataprovidedinthe  article  byDelayetal.,21  and  the  growth  data forthe  article  byZocchiand  Zuliani20  could  not  becomputed.

‡Retentionrate  isthe  quotientofincrementalgrowth  divided  byinjectedvolume.  Calculatedfrom  availabledata.

§Standarddeviation  ofthe  mean  retentionrate  wascalculatedfrom  each  controlgroup’s  availabledata.

 Patientwasdeemednot  tohavebeen  wearcompliantwhen  therewasalessthan  120percentexpansionbefore  surgery.

¶Does  not  enhancethe  grafted  fatinanyway(e.g.,  withstemcells).

 

 

Fig.6.  Dose-responsecurvegeneratedfromthemeasureofmaximalbreast expansionimmediatelybeforefatgrafting(xaxis)andfinal1-yearfollow-up magnetic  resonanceimagingmeasurementofbreast  augmentationvol- ume(yaxis).Astronglylinearresponseisseen(R 2    0.87).

 

 

 


separatingthetissueplanes,increasingtheparen- chymal  space,  and  reducingthe  interstitialpres- sureinthebreast  foragivenleveloffatinjected. Without  preexpansion, thefatplaysthedualrole ofagraftinneed  ofnutrientstosurviveandofan internaltissue  expander.This  isnot  a  serious problemwhen  small  volumes  of  fat  are  trans- plantedbecause   small  amountsdo  not  signifi- cantlyaffectphysiologic  interstitial pressure,and meticulousgraft  dispersioncan  stillpreserve  ad- equaterecipientinterfaceforoxygenandnutrient diffusionintheearlydaysaftergrafting.However,


even  with  the  most  meticulous  grafting   tech- nique,  increasing graftvolumeshasatleasttwo deleterious effects:(1)increasedinterstitial pressureleading  to  decreasedtissue  perfusion and   less  engraftment  potential;  and   (2)   de- creased  graft-to-recipientinterface  in  the crowded,  recipient-isolated graftcollectionslead- ingtonecrosis/apoptosis ofthegraftsinade- quatelyexposed  tonutrients.Byincreasingparen- chymal  space,  Bravaexpansionovercomes  these twolimitationsofhigh-volumegrafting.Insteadof forcingtheirwayunderpressuretoactasinternal


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Fig.7.  Preoperativeexpansionratioversusfinalaugmentation volume.Patientssegregatedonthebasis ofmaximalexpansion frombaseline(relativepercentage),showingastrongtrendfor greateraugmentationwithincreasingmaximalexpansion.

 

 

 

expanders,thegrafted  cellslodgethemselvesinto anexpandedfibrovascularscaffoldandpopulateit. Furthermore, ashasbeen  shownwiththevacuum- assisted closuredevice,vacuumandthemechanical force  ofexpansionpromoteangiogenesisand  the localelaboration andup-regulationofgrowth factors.61,62,115–118Thisincreasedvascularity enhances theabilityofthegrafted  tissuestofeedandsurvive. Itiswellestablishedthatmuscletissuewithitshigh capillarydensityis anexcellentgraftrecipientbed andthat,themorevasculartherecipient,thebetter the   graft   survival.19,119–121    Therefore,  pregrafting Bravapreparationofthebreast  hasdualbeneficial effects:  (1)  aphysical  effect  that  increases  space, reducesgraftcrowdingandfillingpressure,andgen- eratesarecipientscaffold;and(2)abiologicaleffect that  stimulates  angiogeniccytokine  productionto improve  engraftment.30,42,57,60,65,66,69,115,116,122–130

Aftersoilpreparation,thefarmerselectsthebestseeds toplant.Justlikethefarmer  musthavegoodseeds, theharvesting,processing,andreinjectingofadi- pocytesmustbeperformedcarefully.Itisintrying toperfectthese  processes  that  most,ifnot  all,of theenergyandresourcesexpendedinautologous fattransferhave  been  focused  over  the  past  20 years.However,nomatter howmuch  these  areas areimprovedwithnewtools,methods,and  tech- nologies,theyprobably  willnevercompensatefor therate-limitingfactorsofrecipient-siteadequacy,


interstitialpressure,and  graft  revascularization. These  bottleneckswillremain.

Finally,afterpreparingthelandandsowinggood seeds,theymust benurtured.Reapplying  vacuumim- mediately  aftertheprocedureplaysasimilarrole; the  vacuum  immobilizes  the  graftstoallowneo- vascularizationandstimulates  theproliferationof theengraftedcells.117,118,131–134Fromtheface-graft- ingexperience,itiswellknown  that  fatgraftsin themobileperiorbitalregionarenotassuccessful asgrafts  to  otherlessmobile  areas.  Atthe  very least,immediate postgraft  immobilizationis cru- cial.UsingBravapostoperativelyatlow steady pressurehelps  nurturethe  graftbyimmobilizing itasastent,protectingitfromexternaltraumaand keepingopen  millions  oftiny“Morrison  growth chambers,”135,136  whichhavebeen  proven  experi- mentally  to  stimulate   fat  graft  growth.  Further- more,ashasbeenreported,unlessvascularization takesplacewithinarelativelyshortperiod,cellsdo not  survive.

Our  multicenter  prospectivestudy  reveals  a strong  dose-dependent effectofpreoperativeex- pansion tofinalaugmentation. Statisticsprovide more  than  80percentcertainty  thatthefinalaug- mentationwillbeapproximately70percentofthe peakBravaexpansion.Thistakesawaytheunpre- dictability  factor  that  hasplaguedautologousfat transfer.Italsomakesthepatientresponsiblefor her   result   and   stimulates   her   to  comply  with Brava.137Compliantwomenachieveaugmentation volumescomparabletothoseofimplantsinasin- gle-stage(  2hours),incisionlessprocedure.The procedure yieldsanaturalappearingbreast  with the  abilityto  correctdeformitiesand  shape  the breast  betterthan  any“anatomical”implant.

UseoftheBravadeviceispainless.  Painisan alarmfortissueinjury,andatitsearliest  hint,  the womanisaskedtosimplyremovethedomes.How- ever,the  useofBravahasbeen  criticized  as“dif- ficult,”promptingsurgeonstopromotetheprac- ticeofautologousfattransfer without  Brava, especially  in  women  with  involutionalatrophy. Unfortunately,these  practitionersfailto  under- stand  the  conceptsofthree-dimensionalgrafting and  that  ofthe  farmer  elaboratedabove.Loose, atrophiedbreasts  have  alaxskin  envelope,but theystillhavethe  sameparenchymaltissueden- sity.Thus,  asmallloose  breast  isstillasmallre- cipient  breast,  and  attemptstooverfillthat  small dense  tissuewillinvariablylead  tocrowding  and graftloss.Toavoidcrowding,theinterstitialspace hastobespread  open  and  afertile  recipientfi- brovascular  matrix  hastobepreparedwithBrava expansion.Admittedly,loosebreastsaremoreme-


 

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chanically  compliantand  willrespondveryeffec- tivelytotheBravaexpansion.Thus,  togivethese womenthebestresultpossibleina singlegrafting session,itisbesttoconvince  them  ofthe  benefit ofBravaandtoprovidethemwithencouragement andsupportduringtheexpansionprocess.Avery compliantpatientwithverycompliant tissuescan expandby150percentin10 to14 daysandexpect todoubleher  original  breast  volume  toyieldan autologous  tissue  augmentation  in  the   300-ml range  inasingle,  incisionless,  outpatientproce- dure  lasting  lessthan  2hours.  In2007,DelVec- chio  visitedour  centerand  subsequently repro- duced ourresultsindependently.Usingaslightly differentprotocolofBravapreexpansionand  fat grafting,   he  and  coauthorBuckyrecently   pub- lished  this  initial  experiencethat  supports our findings.138

Bravawearrequiresdiscipline and  acommit- ment.  Ifawomancannotcommit  toafewweeks ofBravawear,the  surgical  alternativesareasfol- lows:(1)  proceedwithanautologousfattransfer procedurewithoutBravaandacceptamodestaug- mentationinthe100-to150-mlrange;(2)subject herself  torepeatedautologousfattransferproce- durestoachievewhatshewouldhaveobtainedin onestagehadsheusedBrava;and(3)  commit  to alifetime  withimplants.  Typically,patientswho optforBravaplusautologousfattransfer aredisci- plinedandmoreeducated;thesearecrucialrequire- ments  forcompliance.Itisno  surprise  therefore that86percentofthewomeninourserieshaveat leastacollege  degreeand  that  20percentarein themedical  fieldorareimmediate familyofphy- siciansand  that  four  areradiologists.

Liposuctionand  breast  augmentationconsis- tentlytopthelistofthemostcommonly  performed aestheticsurgeryprocedures.Brava plusautologous fattransferprovides  both  atthe  sametime.  Itisa two-for-oneprocedure,aswemostoftenremovedfat from  where  itisunwantedand  put  itwhere  itis desirable, fulfillingtheage-olddream  oftotalbody reshapingwithout  asingleincision.

Astotheprimordial issueofpatientsafety,in our  6yearsofexperiencewith170breasts  aug- mentedwithBravaplus  autologousfattransfer, ourmain  complicationwasone  atypicalbacterial infection thatwastreatedsuccessfullyandhealed withnosignificantsequelae.Wealsohadonemag- neticresonance imaging  scanthatshowedan equivocal  lesion,  and  that  breast  wasclearedon follow-upstudy.This1.3percent(oneof75)isan expectedfalse-positiverateofbreastmagneticres-

onanceimaging.139Itisimportantto  note  that, althoughtherewereafew fatnecroticfoci,these


werereadily  identifiedand  that  noneofthe  pa- tientshadsuspiciouslesionsrequiringbiopsy.This confirms  recentreportsthat  modernbreast  im- aging  technologycanalmost  alwaysdistinguisha fatnecroticnodulefrom  aneoplasticlesion.  Ra- diologistsarenowrealizing  thatquite  tothecon- traryofobscuringthebreast,autologousfattrans- fer  adds  to  the  breast  aradiolucenttissue  that rendersitlessdense.

Finally,someskepticshaveperniciouslyraised the  possibilitythat  autologousfattransfercould causeorenhancebreastcancer.  Inhumans,there isabsolutely  no  scientific  supportforthat  claim, eventheoretical. TheAmerican  SocietyofPlastic Surgeons  taskforcedidnotfindany,anditwould bepreposteroustoclaimthat  apatient’s  owntis- suesharvestedfrom  one  siteand  transferred to anothersite,asis,withoutanymanipulationwould becomea  carcinogen.This  indictment  shatters theverycoreofplasticsurgery,as thetissuetrans- ferspecialty.Wehavebeen  transferring  massive amountsoffat  into  cancer-proneresidual  post- mastectomydefectswithnoshredofevidencethat thisleadstoanincrease  inrecurrencerate.  Fur- thermore,careful   epidemiologic  review  of  the Frenchand  Italian  experienceswithautologous fattransferto  hundredsofhighly  cancer-prone irradiated  lumpectomydefects  followed  for  10 years didnotrevealany increase  incancer recurrence.27,140   Recent  reviewshave  confirmed the  oncologicsafetyofautologousfattransfer,141 andalthoughwomenshould  alwaysmonitortheir breasts,  thisisnot  anissuethat  should  deter  the acceptanceofthis  highly  satisfactory  alternative andmostnaturalmethodofbreastaugmentation.

 

CONCLUSIONS

Morethan20yearsaftertheAmericanSociety of  Plastic  Surgeons   bannedfat  grafting   to  the breast,  the  debateand  controversy  surrounding thisprocedurecanbelaidtorest.Ourstudyshows thatBravabreastexpansionenablesthetransfer of largevolumesoffatinasinglesessionsafely and effectivelywhileensuringaveryhighsurvivalrate, with  augmentationvolumes  comparableto  im- plants  and  the  addedbenefit ofamore  natural appearanceand  feel.Thisradiographicallymon- itoredlong-termfollow-upofalarge  prospective multicenterstudyestablishes  abenchmarkand  a platformforfurtherpotentialimprovements.

 

RogerK.Khouri,M.D.

MiamiBreastCenter

580Crandon  Boulevard KeyBiscayne,Fla.33149 This email address is being protected from spambots. You need JavaScript enabled to view it.


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