Breast-Conserving Surgery Under Local Anesthesia in Elderly Patients with Severe Cardiorespiratory Comorbidities: A Hospital-Based Case-Control Study

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1 Originl Article Brest Cre 2017;12:29 33 DOI: / Published online: Februry 8, 2017 Brest-Conserving Surgery Under Locl in Elderly Ptients with Severe Crdiorespirtory Comorbidities: A Hospitl-Bsed Cse-Control Study Hsn Krnlik Berky Kılıç Ilknur Yıldırım b Süleymn Bdemler Ilker Ozgur c Burk Ilhn d Semen Onder e Deprtment of Surgery, Institute of Oncology, Istnbul University, Istnbul, Turkey; b Institute of Oncology, Deprtment of Anesthesiology, Istnbul University, Istnbul, Turkey; c Deprtment of Surgery, Acibdem Interntionl Hospitl, Istnbul, Turkey; d Deprtment of Surgery, Istnbul University School of Medicine, Istnbul, Turkey; e Deprtment of Pthology, Institute of Oncology, Istnbul University, Istnbul, Turkey Keywords Brest cncer Lymph nodes Surgery Locl nesthesi Brest-conserving surgery Sfety Generl nesthesi Summry Introduction: We report the fesibility nd sfety of locl nesthesi (LA) in ptients hving brest-conserving surgery (BCS). Methods: 37 ptients with Americn Society of Anesthesiologists (ASA) score of 4 hving BCS under LA nd 54 ge-mtched subjects with ASA score of 3 4 hving BCS under generl nesthesi (GA) were included. Ptients were retrospectively evluted for the follow-up durtion, durtion of surgery, postopertive stisfction scores (1 10), compliction nd survivl time for locoregionl recurrence nd overll survivl rtes. Results: The men follow-up durtion ws ± months (rnge ) in GA group, nd 58.7 ± 15.5 months (rnge 20 99) in LA group. There ws significnt difference in the durtion of surgery (p < 0.001). In the LA group, 5 ptients (13.5%) hd minor complictions including serom, wound infection or hemtom, wheres 6 ptients (11.1%) hd minor complictions in the GA group (p > 0.05). The re-excision rte due to positive tumor mrgins ws 5.4% (2 ptients) in the LA group nd 5.5% in the GA group, respectively. The locoregionl recurrence-free survivl nd overll survivl rte ws not different between 2 groups (p = 0.192, p = 0.93). Conclusion: BCS under LA seemed to be effective nd sfe in selected high-risk elderly ptients S. Krger GmbH, Freiburg Introduction Brest cncer is the most frequently dignosed cncer mong women ged yers. Bsed on the vilble dt, between 2007 nd 2011, the number of new cses with brest cncer ws reported to be per 100,000 women per yer [1]. Since ge is known risk fctor for brest cncer, the incidence of brest cncer is expected to increse in the ner future due to the demogrphic chnges. Although brest cncers occurring in women ged 75 yers or more t the time of dignosis show higher proportion of cses with fvorble prognostic chrcteristics, the presence of comorbidities such s hypertension, dibetes mellitus nd hert disese my led to incresed risk t surgery. An ssocition hs been reported between older ge nd peri/postopertive complictions, including erly postopertive cognitive dysfunction, incresed durtion of nesthesi, postopertive infection nd respirtory complictions [2]. Although generl nesthesi (GA) provides optiml conditions for brest-conserving surgery (BCS), dvnced ge nd comorbidities my represent contrindiction for opertions under GA in older women [3]. Moreover, the opertive mortlity for ptients ged 80 yers of older increses more thn 2-fold compred to ptients of yers of ge [4]. The known intropertive nd postopertive risks of GA for the elderly popultion encourged us to perform BCS under locl nesthesi (LA) in selected ptients. Here we report our experience with BCS performed under LA with light sedtion, nd compre the outcomes of these ptients with ge-mtched controls hving BCS under GA. Fx Informtion@Krger.com S. Krger GmbH, Freiburg Accessible online t: Ilknur Yıldırım, MD Deprtment of Anesthesiology, Institute of Oncology Istnbul University,Turgut Ozl street, Istnbul, Turkey yhoo.com

2 Tble 1. Chrcteristics of ptients in the LA nd GA groups Ptients, n Men ge ± SD, yer (rnge) 72.4 ± 6 (68 76) 71.1 ± 3.7 (67 81) 0.67 BMI, men ± SD (rnge) ± 3.9 (19 37) ± 3.4 (19 35) 0.54 ASA sttus (n) IV (37) III (45), IV (9) LA = locl nesthesi, GA = generl nesthesi, SD = stndrd devition, BMI = body mss index, ASA = Americn Society of Anesthesiologists. Methods This study comprised ptients with erly brest crcinom who received BCS under either LA or GA. Erly stge brest crcinom ws defined s T1/ T2N0. We performed hospitl-bsed, cse-control study of 37 ptients who hd n ASA (Americn Society of Anesthesiologists) score of clss III IV nd who received surgery under LA nd 54 ged-mtched controls who hd surgery under GA. The possibility of being operted under LA ws offered to ll ptients with ASA clss III IV. The control subjects were mtched to cses in respect to ge (older thn 65 yers) in the sme study period. All surgeries were performed t the Institute of Oncology, Istnbul University, between 2007 nd The study ws pproved by the locl Ethics of Humn Reserch Committee, nd informed consent form ws obtined from ech ptient prior to the surgery. This mnuscript complies with the current lws of the country in which they were performed. ASA score (I IV) ws used for the opertive risk evlution. Ptients with ASA clss III IV (37 ptients) underwent surgery under LA, wheres GA ws used in ptients with ASA clss III (45 ptients) nd lso in ptients who refused surgery with LA (9 ptients). An nesthesiologist nd nurse were present t ll times during the opertion. All ptients received continuous monitoring by electrocrdiogrm nd pulse oximetry. Oxygen ws given t 2 l/min vi oxygen msk without dditionl respirtory support nd oxygen sturtion ws mintined t %. For the sedtion in the LA group, combintion of 2 mg midzolm (Dormicum, 5 mg/ml, Roche, Switzerlnd) intrvenously (IV), 1 μ/kg fentnyl (5 mg/10 ml, Abbott, USA) IV, nd 0.5 mg/kg IV bolus with 0.1 mg/kg/min infusion of propofol (Pofol, 10mg/ml, Sndoz, Switzerlnd) ws used. Surgicl Procedure A preopertive lymphoscintigrphy ws crried out systemticlly to mrk the sentinel node. 60 MBq Technetium-99m nnocolloids, perireolr rdioctive trcer, ws injected to the qudrnt of the disesed brest. The surgicl procedure begn with xillry intervention. The loction of the sentinel lymph node (SLN) ws identified on the skin using the gmm probe (Clerd, Gmm-Sup, Frnce). 5 ml of 2% prilocine hydrochloride (Citnest 2%, 20 mg/ml, AstrZenec, Sweden) ws injected intrdermlly into the xillry site. If needed, more locl nesthetic ws injected during surgery, but cre ws tken not to exceed the sfe dose. The stndrd incision strted from the nterior nd extended to the dorsl xillry hirline. The SLN in the xillry ftty tissue ws recognized by its rdioctivity. The rdioctivity of the excised SLN ws recorded ex vivo, nd bckground ctivity lso ws evluted. If bckground ctivity ws found, further dissection ws performed to find ny other rdioctive lymph node. Frozen sections of the tissue were exmined pthologiclly. Ptients with positive SLN then underwent xillry lymph node dissection up to level 2 using extr prilocine hydrochloride. The skin incisions for lumpectomy were mde on the skin mrkings. If needed, more locl nesthetic ws injected. Lumpectomy ws completed using the stndrd procedure. Wounds were closed with synthetic bsorbble surgicl suture without dringe. For ll ptients, intrmusculr diclofenc sodium (Voltren, 75 mg/3 ml, Novrtis, Switzerlnd) ws injected to reduce postopertive pin. A stndrd GA technique ws used for the GA group. Postopertive pin control protocols were stndrdized for both groups nd ll ptients were provided prcetmol 1,000 mg IV.Mjor nd minor complictions were ssessed during the follow-up. Minor complictions included wound infection, hemtom, serom, lymphedem, brest tenderness, nd prolongtion of hospitl sty. Mjor complictions included brchil plexus injury, pneumothorx, nd deth due to surgery or nesthesi. Stisfction Scores Ech ptient ws given n nonymous questionnire bout the procedure, which ws collected before the ptient ws dischrged postopertively. The questionnire comprised 2 pges: the first concerning demogrphic informtion, nd the other on postopertive findings, such s tiredness, nuse, vomiting, nd intensity of pin. The Visul Anlogue Scle ws used to mesure the postopertive brest nd xillry pin intensity, tiredness, nxiety, nuse, qulity of sleep. Vomiting ws evluted s bsent or present. An overll stisfction score ws lso clculted. Ptients were sked if they would choose similr surgicl procedure gin nd if they would recommend it to fmily nd friends. All of these items were rted on the scle of 1 10 (1 being the lowest score: very bd or lower level of well-being, nd 10, the highest: very good or higher level of well-being). Sttisticl Anlysis The outcomes, including demogrphicl dt, periopertive complictions, surgicl mrgins, nd histopthologicl results, were compred between the 2 groups. The normlity ws checked using the Shpiro-Wilk tests. The Mnn- Whitney test or Kruskl-Wllis test ws used to compre continuous vribles between the 2 groups. Chi-squre test or Fisher test ws used to compre nominl vribles between the groups. Kpln-Meier curves were generted for time to locoregionl recurrence nd overll survivl time. All nlyses were done using SPSS 23 softwre (IBM, US). p vlues represent results for 2-sided tests, with vlues less thn 0.05 considered sttisticlly significnt. Results There were 37 brest cncer ptients in LA group nd 54 ptients in GA group. The demogrphic dt of the ptients re given in tble 1. There ws no significnt difference in ge, ASA sttus nd body mss index between the 2 groups. The men follow-up durtion ws ± months (rnge ) in GA group, nd 58.7 ± 15.5 months (rnge 20 99) in LA group; the difference in follow-up durtion ws not significnt (p = 0.164). The durtion of surgery ws significntly longer in GA group thn LA group (p < 0.001). The surgicl procedures performed re given in tble 2. The histopthologicl chrcteristics of the tumor in LA nd GA groups re given in tble 3. The ductl-type brest cncer ws the most common type of tumor in both groups. Although tumor size nd tumor volume were lrger in the LA group thn the GA group, this difference ws not significnt. Positive or close surgicl mrgins (1 mm or < 1 mm) were lso similr in the 2 groups. In the 30 Brest Cre 2017;12:29 33 Krnlik/Kılıç/Yıldırım/Bdemler/Ozgur/Ilhn/ Onder

3 Tble 2. Performed surgicl procedures n BCS + SLNB, n (%) 24 (64.9%) 33/54 (61.1%) 0.65 BCS+AD, n (%) 13 (35.1%) 21/54 (38.9%) 0.53 Durtion of surgery, min ± SD (rnge) 49 ± 34 (40 60) 60 ± 45 (35 75) < LA = locl nesthesi, GA = generl nesthesi, BCS = brest-conserving surgery, SLNB = sentinel lymph node biopsy, AD = xillry dissection. Tble 3. Histopthologicl chrcteristics of the tumors in the LA nd GA groups Tumor type, n Ductl Lobulr 3 2 Mixed type 2 3 Other 1 3 Tumor size, men mm ± SD (rnge) 25 ± 11 (0 48) 22 ± 13.7 (0 55) Tumor volume, men mm3 ± SD (rnge) 249 ± 81 ( ) 231 ± 92 ( ) SLN metstsis, n (%) 13 (35.1) 25 (48.1) Micrometstsis, n (%) 4 (30.7) 12 (48) Mcrometstsis, n (%) 9 (69.3) 13 (52) Men number of excised ALN (rnge) ± 9.5 (6 24) 13.8 ± 11(18 28) Men number of excised metsttic ALN (rnge) 1.65 ± 1.46 (0 22) 1.43 ± 2.64 (0 10) Invsive tumor mrgins, n (%) Close to 1 mm 2 (5.4) 3 (5.6) 1 2 mm 2. (5.4) 3 (5.6) 2 5 mm 13 (35.2) 29 (53.7) > 5 mm 20 (54.0) 19 (35.1) LA = locl nesthesi, GA = generl nesthesi, SLN = sentinel lymph node, ALN = xillry lymph node LA group, in 2 ptients re-excision ws performed using the sme surgicl technique due to positive mrgins, while 3 ptients in the GA group underwent re-excision for positive mrgins. The identifiction rte of the SLN biopsy procedure ws 100%. The men volume of nesthetic gent used for lumpectomy nd SLN biopsy ws ± 1.7 ml (rnge 14 20). When xillry dissection ws performed in SLN positive ptients, men of ± 1.45 ml (rnge 20 25) nesthetic gent ws used. In LA group, 5 ptients (13.5%) hd minor post-periopertive complictions, including serom formtion, wound infection nd hemtom. Minor complictions occurred in 6 ptients (11.1%) in the GA group. There ws no significnt difference in the rte of minor complictions between the 2 groups (p > 0.05). There were no cses of mortlity or other mjor complictions relted to nesthesi or surgery, nd no cses required conversion to GA. All ptients were ble to complete the questionnires using the scles. The men overll stisfction score ws 7.7 ± 1.6 in LA group nd 8 ± 1.7 in the GA group, respectively (p = 0.7). There ws no significnt difference in postopertive scores for tiredness, nxiety, qulity of sleep nd pin intensity between the 2 groups (p > 0.05 for ll symptoms). Nuse score ws significntly higher in the GA group thn in the LA group (p = 0.02). The comprison of the postopertive symptom score is shown in figure ptients (97%) in the LA group nd 54 ptients (100%) in the GA group declred tht they would hve surgery in the sme wy Tble 4. Recurrence rtes in the LA nd GA groups LA group GA group n Locoregionl recurrences, n (%) 2 (5.4) 2 (3.7) Contrlterl recurrences, n (%) 1 (2.7) 0 Distnt metstses, n (%) 2 (5.4) 1 (3.7) LA = locl nesthesi, GA = generl nesthesi gin. 36 ptients (97%) in LA nd 52 (96%) ptients in GA group sid tht they would recommend similr surgicl intervention to their fmily nd friends. The medin follow-up of durtion ws 56 months (rnge 20 99) in the LA group nd 53 months (rnge ) in the GA group. All ptients were dischrged the dy fter surgery. All ptients hd physicin office visits every 6 months during the follow-up period. In the LA group, 2 ptients hd the locl recurrence, 1 fter 17 months nd the other fter 66 months. In the LA group, 2 ptients exhibited distnt metstses, 1 to the liver fter 34 months nd the other to the lung fter 42 months. The recurrence rtes re given in tble 4. There were no significnt differences in overll survivl probbility nd time for locoregionl recurrence between the LA nd GA groups (log Rnk, chi-squre, p = 0.93; log Rnk, chi-squre, p = 0.192, respectively). Figures 2 nd 3 show the Kpln-Meier nlysis time for locoregionl recurrence nd overll survivl rtes. Brest-Conserving Surgery Under Locl Brest Cre 2017;12:

4 Fig. 1. Shows the postopertive symptoms scores in the locl nesthesi (LA) nd generl nesthesi (GA) groups. There is no significnt difference between the 2 groups except for nuse (p = 0.02). Fig. 2. Kpln-Meier curve shows the locoregionl recurrence time between the locl nesthesi (LA) nd generl nesthesi (GA) group. There is no significnt difference (p = 0.192). Fig. 3. Kpln-Meier curve shows the overll survivl time in the locl nesthesi (LA) nd generl nesthesi (GA) groups. There is no significnt difference (p = 0.93). Discussion Brest cncer is growing helth problem in the elderly popultion. Historiclly, to control the locl growth of this disese, mstectomy performed under GA hs been the technique of choice. Although more thn 50% of ptients over 70 yers of ge suffer from 1 comorbidity nd 30% suffer from 2 or more comorbidities tht might increse the opertive risks under GA even for stge I or II brest cncer [5], chronologicl ge should not be considered n exclusion criterion for the surgery. LA is sfe nd effective method of preventing morbidity in ptients who hve substntil risk for GA due to older ge nd comorbidity. Successful mjor surgeries under LA hve lredy been reported, nd LA should be preferred when it is necessry. There hve been limited number of reports showing the outcomes of 32 Brest Cre 2017;12:29 33 Krnlik/Kılıç/Yıldırım/Bdemler/Ozgur/Ilhn/ Onder

5 mstectomy in elderly nd high-risk ptients [6 8]. Bsed on these studies, mstectomy could be sfely performed under LA without incresing the mortlity. In our study, 35% of ptients hd xillry dissection without mstectomy under LA. Although the men postopertive stisfction score ws found to be slightly higher in ptients with xillry dissection thn tht of SLN ptients, the intervention ws well tolerted in ll ptients. No mjor complictions occurred following the surgery under LA. A Jpnese study group [9] reported the oncologicl sfety of BCS nd SLN biopsy in 23 ptients with medin ge of 60 yers. The uthors used pentzocine for pin reduction in the mpping mteril injection, lidocine s (1%) locl nesthetic gent nd gve IV sedtion to the ptients during the surgery, which took medin of 77 min. The SLNs were identified in ll ptients nd 1 ptient underwent xillry dissection on nother dy under GA due to positive SLN [10]. Despite hving sfe profile, some severe systemic dverse effects my occur fter the dministrtion of locl nesthetic gents, such s methemoglobinemi nd nphylxis. A ptient s helth sttus, the presence of chronic systemic disese (such s crdiovsculr disese, heptic nd renl dysfunction) my mplify the likelihood of these complictions. Therefore, ptient should be crefully monitored intr- nd postopertively for ny possible sign of locl nesthetic rection to mnge these side effects successfully. Moreover, the decision for the pproprite selection of ptient should be done bsed on the ptient s medicl, surgicl history nd pre-nesthesi consulttion. In our study, fter reviewing the detiled medicl history nd lbortory evlution for ech ptient, ll ptient hd preopertive nesthesi consulttion to determine the proper nesthetic gent, nd to ssess the potentil risks tht ptient might hve following the surgery. Eligible ptients for LA were selected fter this preopertive nesthesi consulttion nd ll ptients were crefully ssessed for the potentil postopertive risks. None of our ptients hd ny nesthesi-relted compliction. We successfully performed BCS with or without xillry dissection in 37 ptients under LA nd light sedtion IV. We could not detect ny side effects relted to nesthetic gent. In our study, there ws no significnt difference in recurrence nd survivl rtes between the LA group nd GA group. In the LA group, 2 of 37 ptients (5.4%) hd re-excision due to positive surgicl mrgin, while 3 of 54 ptients (5.5%) required re-excision in the GA group. The re-excision rte ws not different between the groups. Our results suggested tht use of combined LA nd mild sedtion my be sfe option in selected elderly nd high-risk ptients. Our study hs some limittions, including the smll smple size nd observtory design. Prospective studies with lrger number of ptients re needed to confirm the superiority of this technique in selected cses. In conclusion, BCS under LA, s n lterntive to GA, seems to be sfe nd effective option in high-risk nd elderly popultions. However, pproprite ptient selection should be done with the nesthesiologist, nd ptients should be crefully monitored for the potentil risks postopertively. Disclosure Sttement None of the uthors hs finncil or proprietry interest in ny mteril or method mentioned. References 1 Ntionl Cncer Institute, Surveillnce Epidemiology nd End Results (SEER), Moller JT, Cluitmns P, Rsmussen LS, et l.: Longterm postopertive cognitive dysfunction in the elderly. ISPOCD1 study. Lncet 1998; 351: Yncik R, Wesley MN, Ries LA, et l.: Effect of ge nd comorbidity in postmenopusl brest cncer ptients ged 55 yers nd older. JAMA 2001; 285: Finlyson EV, Birkmeyer JD: Opertive mortlity with elective surgery in older dults. Eff Clin Prct 2001; 4: Betteli G: Preopertive evlution in geritric surgery: Comorbidity, functionl sttus nd phrmcologicl history. Minerv Anestesiol 2011; 77: Dennison AR, Wtkins RM, Wrd ME, Lee EC: Simple mstectomy under locl nesthesi. Ann R Coll Surg Engl 1985; 67: Crlson GW: Totl mstectomy under locl nesthesi: The tumescent technique. Brest J 2005; 11: Joseph AY, Bloch R, Yee S: Simple nesthesi for simple mstectomies. Brest Cncer Res Tret 2003; 77: Hirokw T, Kinoshit T, Ngo T, Hojo T: A clinicl tril of curtive surgery under locl nesthesi for erly brest cncer. Brest J 2012; 18: Okley N, Dennison AR, Shorthouse AJ. A prospective udit of simple mstectomy under locl nesthesi. Eur J Surg Oncol 1996; 22: , errtum ppers in Eur J Surg Oncol 1996; 22: 560. Brest-Conserving Surgery Under Locl Brest Cre 2017;12: