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 Table of Contents  
ORIGINAL ARTICLE
Year : 2017  |  Volume : 2  |  Issue : 2  |  Page : 62-67

Antibiotic prophylaxis for permanent pacemaker implantation: A survey in chinese electrophysiological centers


The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

Date of Web Publication31-Jan-2018

Correspondence Address:
Dr. Keping Chen
The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/IJHR.IJHR_14_16

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  Abstract 


Background: The practice of antibiotic prophylaxis for permanent pacemaker implantation varied widely in the real world of clinical practice due to no guidelines. The present study aims to investigate the use of antibiotic prophylaxis peri- and postimplantation of pacemaker in China. Materials and Methods: A total of 141 adult heart centers performing device implantation were asked using an E-mail or paper questionnaire to collect data regarding the use of antibiotics before or at implantation and duration of postimplantation. Subsequent telephone calls and E-mails were used to ascertain dubious data if necessary. Results: The final analysis included 135 centers (95.7% of total contacted) covering 7 main geographic regions of China. One hundred and twenty-six of the 135 centers (93.3%) used prophylactic antibiotics peri- and postimplantation. Among these centers, 107 centers (84.9%) selected first- or second-generation cephalosporins. In 100 centers (79.4%) of those used systemic antibiotics, an initial dose was given 0.5–2 h before surgery. With respect to duration of antibiotics administration, 99 centers of those used prophylactic antibiotics (78.6%) continued antibiotic therapy for 24–72 h while only 10 centers (7.9%) just administrated a single dose of antimicrobial agent before commencement of a procedure. Forty-eight of the 135 centers (35.6%) used intrapocket antibiotics at implantation, and gentamicin was the most commonly used antimicrobial agent (in 39/48 centers). Conclusion: Although the administration of prophylactic antibiotics before permanent pacemaker implantation has been implemented widely and routinely, our results showed that some electrophysiological centers still used no systemic antibiotic prophylaxis before or at the implantation. A significant difference exists in the timing, duration, and type of antibiotics use. Clinical trial evidence are required to guide optimal antibiotic prophylaxis for device implantation.

Keywords: Antibiotic, pacemaker, periprocedure, prophylaxis


How to cite this article:
Chen K, Fan X, Hua W, Zhang S. Antibiotic prophylaxis for permanent pacemaker implantation: A survey in chinese electrophysiological centers. Int J Heart Rhythm 2017;2:62-7

How to cite this URL:
Chen K, Fan X, Hua W, Zhang S. Antibiotic prophylaxis for permanent pacemaker implantation: A survey in chinese electrophysiological centers. Int J Heart Rhythm [serial online] 2017 [cited 2018 Aug 20];2:62-7. Available from: http://www.ijhronline.org/text.asp?2017/2/2/62/224355




  Introduction Top


Because of an increasingly aging population and the rapid evolution of device-based therapies these days, the number of people receiving permanent pacemaker and other cardiovascular implantable electronic devices is increasing dramatically. It is no wonder that recent data have shown an increase in rates of cardiac rhythm management device infections out of proportion to rates of new device implants.[1] Device infection is an uncommon but devastating complication after implantation and confers a high in-hospital mortality rate. The incidence of device infection varies from 0.13% to 19.9% in prior studies.[2],[3],[4] Pacemaker-related endocarditis shows a high mortality of 27% after a mean follow-up of 20 months.[5] Besides causing morbidity and even death, device infection is also associated with significant financial cost for patients. Staphylococcus species (including Staphylococcus aureus and coagulase-negative staphylococci) are the predominant organisms responsible for both early- and late-onset infections.[6],[7]

So far, there are no guidelines on systemic prophylactic antibiotic use in pacemaker implantation although the administration of prophylactic antibiotics at the time of pacemaker implantation has been implemented widely and routinely. Early trials yielded contradictory results and had limitations including the small study numbers, a low incidence of infection, as well as inconsistent definitions of infection.[8],[9],[10] However, Da Costa et al.[11] undertook a meta-analysis of antibiotic prophylaxis for permanent pacemaker implantation in 1998 and demonstrated a significant reduction in the incidence of infection. The benefit of antibiotic prophylaxis in the prevention of cardiac device implant infections was then established and verified by following studies in recent years.[12],[13]

However, few data are available on selection of prophylactic antibiotic regimens, efficacy of intrapocket antibiotic use and the duration of prophylactic antibiotic use postimplantation. In clinical practice, the decision on whether and how to use systemic prophylactic antibiotics is usually at the discretion of the operators. Thus, great variation might exist in different hospitals. The aim of this survey was to determine the current status of antibiotic prophylaxis for permanent pacemaker implantation in Chinese electrophysiological centers.


  Materials and Methods Top


A survey across all adult hospitals with the approved certification by Ministry of Health in pacemaker implantation was conducted from January to March in 2012. Private hospitals and pediatric cardiology units were excluded, as well as adult hospitals if the director refused to participate the investigation. One hundred and forty-one centers received questionnaires. Among them, 135 centers completed questionnaires. An E-mail questionnaire was sent to directors of electrophysiological centers for data regarding antibiotic prophylaxis for permanent pacemaker. Specially assigned person completed this questionnaire and the director verified the data integrity and accuracy. Data would be verified through telephone, E-mail, or follow-up if no response or some doubts existed.

The questionnaire includes the following items related to peri-implantation antibiotic prophylaxis in each center: (1) implantation volume, (2) whether peri-implantation antibiotic prophylaxis was used, (3) onset timing of antibiotic prophylaxis, (4) location of antibiotic use, (5) type of antibiotics, (6) type of antibiotics in case of penicillin or cephalosporin allergy, (7) route of administration of prophylactic antibiotics, (8) duration of prophylactic antibiotic use, (9) whether intra-pocket antibiotics was used; (10) type of intra-pocket antibiotics, (11) whether antibiotics were used postimplantation, (12) whether antibiotics used pre- and post-implantation were the same type, (13) route of administration postimplantation, and (14) duration of antibiotic use postimplantation.

Statistical analysis

The quantitative variables were represented as numbers and proportions. The classifying variables were compared by utilizing the Chi-square test. SPSS 11.0 software (IBM SPSS Software, SPSS Inc., Chicago, IL, USA) was used for statistical analyses, with a significance level set at P = 0.05.


  Results Top


Survey summary

A total of 154 questionnaires were received after sending E-mail questionnaire to 121 centers and paper questionnaire to 20 centers. Among them, 26 questionnaires were repetitive from 13 hospitals and questionnaires from 7 centers were incomplete. By verification through telephone, E-mail, or follow-up, one hospital finished the incomplete questionnaire. Finally, 13 repetitive questionnaires and 6 in complete questionnaires were excluded from the study. Questionnaires from 135 centers were valid, and [Figure 1] illustrated the process of data collection. [Figure 2] showed the center distribution. The number of centers with implantation volume <100 was 56 (41.5%), with implantation volume between 100 and 200 was 43 (31.9%), with implantation volume between 200 and 300 was 18 (13.3%), with implantation volume more than 300 was 18 (13.3%).
Figure 1: Data collection process. One hundred and twenty-one questionnaires were sent by E-mail and 20 were sent by mail. A total of 154 questionnaires were received. Among them, 13 centers submitted both E-mail and mail questionnaires and questionnaires from other 7 centers were incomplete. By verification, 1center finished the incomplete questionnaire. Finally, 135 questionnaires were valid

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Figure 2: Distribution of 135 centers. East China: Jiangsu Zhejiang Anhui Fujian Jiangxi Shandong Shanghai Taiwan; South China: Guangdong (including Dongsha Islands) Guangxi Hainan (including Spratly Islands) Hong Kong SAR Macao SAR; North China: Hebei Shanxi Beijing Tianjin Inner Mongolia; Central China: Hubei Hunan Henan; Northeast China: Liaoning Jilin Heilongjiang; Southwest China: Sichuan Yunnan Guizhou Chongqing Tibet Autonomous Region Southern Shaanxi; Northwest China: the Ningxia Hui Autonomous Region the Xinjiang Uygur Autonomous Region Qinghai Shaanxi Gansu

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Antibiotic prophylaxis peri-implantation

Among 135 centers, 7.4% centers (10/135) administered single dose of prophylactic antibiotics preimplantation which was discontinued postimplantation; 75.5% centers (102/135) used prophylactic antibiotics pre- (including at implantation) and postimplantation; 10.4% centers (14/135) gave prophylactic antibiotics to patients postimplantation; 6.7% centers (9/135) did not use any prophylactic antibiotics during implantation including pre, at and postimplantation [Figure 3]. In conclusion, 93.3% centers used prophylactic antibiotics pre- or post-implantation while 6.7% centers did not. The distribution of centers where prophylactic antibiotics were not administrated were 5 in Yunnan, 2 in Guangdong, 1 in Sichuan, and 1 in Jiangsu.
Figure 3: Antibiotic prophylaxis peri-implantation. Among 135 centers, 10 centers administered single dose of prophylactic antibiotics preimplantation; 102 centers used prophylactic antibiotics pre- and post-implantation; 14 centers gave prophylactic antibiotics to patients postimplantation; 9 centers did not use any prophylactic antibiotics during implantation including pre, at and postimplantation

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Types of antibiotics

Among 135 centers, 5.2% centers (7/135) did not point out the type of antibiotics; 79.3% centers (107/135) selected first- or second-generation cephalosporins or penicillins; 6.7% centers (9/135) selected third-generation cephalosporins such as ceftriaxone sodium, ceftazidime, cefoperazone, and ceftizoxime sodium; 2.2% centers (3/135) selected quinolones [Figure 4]. If patients are allergic to cephalosporins or penicillins, 27.4% centers (37/135) would change to clindamycin or lincomycin, 38.5% centers (52/135) would change to quinolones (levofloxacin, ciprofloxacin, moxifloxacin hydrochloride, etc.), 12.6% centers (17/135) would use macrolides (azithromycin, kitasamycin, and vancomycin); 3.0% centers (4/135) would select other antibiotics, for example, aztreonam [Figure 5]. Sixteen centers (11.9%) did not state clear, and 9 centers (6.7%) did not use prophylactic antibiotics.
Figure 4: Types of antibiotics. Among 135 centers, 107 centers selected first- or second-generation cephalosporins or penicillins; 9 centers selected third-generation cephalosporins such as ceftriaxone sodium, ceftazidime, cefoperazone, and ceftizoxime sodium; 3 centers selected quinolones; 7 centers did not point out the type of antibiotics

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Figure 5: Types of antibiotics in case of allergy. Among 135 centers, 37 centers would change to clindamycin or lincomycin, 52 centers would change to quinolones (levofloxacin, ciprofloxacin, moxifloxacin hydrochloride, etc.), 17 centers would use macrolides (azithromycin, kitasamycin, vancomycin); 4 centers would select other antibiotics, for example, aztreonam

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Timing and location of antibiotic use

The onset timing of antibiotic prophylaxis varied greatly among centers. 5.2% centers (7/135) gave the initial dose between 3 and 6 h before implantation; 74.1% centers (100/135) started therapy between 0.5 and 2 h before implantation, while the remaining 10.4% centers (14/135) used antibiotics after implantation [Figure 6]. Among 126 centers where prophylactic antibiotics were used, 25.4% centers (32/126) used antibiotics in catheter rooms, while the remaining 74.6% centers used antibiotics in wards [Figure 7]. With respect to methods for application, 94.6% centers selected intravenous drip, and 5.4% centers chose intravenous injection [Figure 8].
Figure 6: Timing of antibiotic use. Among 135 centers, 7 centers gave the initial dose between 3 and 6 h before implantation; 100 centers started therapy between 0.5 and 2 h before implantation; 14 centers used antibiotics after implantation

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Figure 7: Location of antibiotic use. Among 126 centers where prophylactic antibiotics were used, 32 centers used antibiotics in catheter rooms, and 94 centers used antibiotics in wards

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Figure 8: Route of administration of prophylactic antibiotics. Among 126 centers where prophylactic antibiotics were used, 119 centers selected intravenous drip, and 7 centers chose intravenous injection

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Duration of prophylactic antibiotic use

The duration of prophylactic antibiotic therapy also varied among centers. Nearly 7.9% centers (10/126) only gave single dose of antibiotics to patients before implantation; 27.8% centers (35/126) used antibiotics continuously for 24 h; 21.4% centers (27/126) used antibiotics continuously for 48 h; 29.4% centers (37/126) used antibiotics continuously for 72 h (one center changed to oral antibiotics after implantation); and 13.5% centers (17/126) used antibiotics continuously for over 72 h [Figure 9].
Figure 9: Duration of prophylactic antibiotic use. Among 126 centers where prophylactic antibiotics were used, 10 centers only gave single dose of antibiotics to patients before implantation; 35 centers used antibiotics continuously for 24 h; 27 centers used antibiotics continuously for 48 h; 37 centers used antibiotics continuously for 72 h; 17 centers used antibiotics continuously for over 72 h

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Use of intrapocket antibiotics

Nearly 35.6% centers (48/135) used antibiotics for pocket washing at implantation [Figure 10]. Among these centers, 81.3% centers (39/48) selected gentamicin solution, while the other 9 centers (18.7%) used different antibiotics including clindamycin, amikacin, levofloxacin mesylate, metronidazole, penicillin, and cefuroxime [Figure 11]. Among 9 centers where no prophylactic antibiotics were used neither pre- or post-implantation, 5 centers (55.6%) washed pocket with antibiotics during operation. Among 10 centers where only preimplantation antibiotic prophylaxis was used, only 1 center (10%) used amikacin to wash pocket. Six centers where implantation volume was more than 500/year did not wash pocket with antibiotics.
Figure 10: Use of intrapocket antibiotics. Among 135 centers, 48 centers used antibiotics for pocket washing at implantation while 87 centers did not use

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Figure 11: Types of intrapocket antibiotics. Among 48 centers where intrapocket antibiotics were used, 39 centers selected gentamicin solution, 9 centers used different antibiotics including clindamycin, amikacin, levofloxacin mesylate, metronidazole, penicillin, and cefuroxime

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Implantation volume of centers and antibiotic prophylaxis

According to implantation volume per year, centers were divided into four groups including <100, between 100 and 200, between 200 and 300, and more than 300. By comparing antibiotic regimens used, onset timing, and duration, as well as the use of intra-pocket antibiotics, difference among groups was not statistically significant (P > 0.05).


  Discussion Top


In our survey, most centers (82.9%) used antibiotic prophylaxis before or after implantation. About 79.2% centers selected first- or second-generation cephalosporins or penicillins, and 74.1% centers gave the initial dose between 0.5 and 2 h before implantation. However, only 12.6% centers used antibiotics continuously for over 72 h after implantation. 35.6% centers (48/135) washed pocket with antibiotics at implantation and gentamicin solution was selected by most centers.


  Role of Antibiotic Prophylaxis during Peri-Implantation Period Top


Pacemaker infections represent a life-threatening complication. Previous studies have reported a 27% mortality in infective endocarditis.[5] A retrospective study in China analyzed 1869 patients, and pocket infection rate after implantation was 1.11%. Earlier trials have found that prophylactic use of cloxacillin could reduce pacemaker infection rate during 1–43 months' follow-up period compared with placebo (2% vs. 14%).[4] PEOPLE study was a prospective and multicenter clinical trial in France, which enrolled 6319 patients implanted with antiarrhythmic devices from 47 hospitals and the follow-up period was 12 months with all infection complication recorded.[5] Multivariate analysis revealed a negative correlation between antibiotic prophylaxis and infection, and it was recommended that antibiotics should be used both before and after implantation. Recent study found that the administration of one dose of 1 g cefazolin before implantation could reduce infection rate at 6-month follow-up compared with placebo (0.63% vs. 3.28%, P = 0.016).[13] Meta-analysis also confirmed the protective role of antibiotic prophylaxis against infection (odds ratio = 0.25, 95% confidence interval: 0.10–0.66).[11] In our survey, a very few centers (6.7%) do not use antibiotic prophylaxis neither before or after implantation. Taken sterile condition of operating room into consideration, we strongly recommend the routine use of antibiotic prophylaxis.


  Type Selection of Prophylactic Antibiotics during Peri-Implantation Period Top


Many studies have verified that Staphylococcus, especially S. aureus is the primary pathogenic bacterium of pacemaker infection.[14] The antibacterial spectrum of prophylactic antibiotics should include S. aureus. In case of β-lactam antibiotics allergy, clindamycin should be used. However, the use of fluoroquinolones should be strictly controlled. In our survey, 89% centers selected β-lactam antibiotics (penicillins and cephalosporins) which could control pathogenic bacterium. However, several centers chose third-generation cephalosporins, and few centers used quinolones. In case of penicillin allergy, 54% centers changed to quinolones. In view of bacterial drug resistance, selection of prophylactic antibiotics should be restricted. Many centers in China should increase awareness of prophylactic antibiotics.


  Timing and Duration of Use of Prophylactic Antibiotics during Peri-Implantation Period Top


In our survey, the onset timing of use of prophylactic antibiotics varied among centers. A lot of studies have been conducted in timing and effectiveness of prophylactic antibiotics in surgical area. With different onset timing of use of prophylactic antibiotics, infection rate differs. If antibiotics were used within 1 h before surgery, the infection rate was 0.6%; if used during surgery, the infection rate was 1.4%; if used after surgery, the infection rate would increase to 3.3%. If antibiotics were used between 3 and 24 h before surgery, the infection rate was 3.8%, 6.7 times higher than the rate used within 2 h before surgery.[15] Therefore, it is recognized that prophylactic antibiotics should be used within 0.5 and 2 h before surgery. Many foreign intervention centers require the use of antibiotics after patients arrive at intervention catheter room to make sure appropriate antibiotics can be used at reasonable time. In our survey, antibiotics were used in only 25.4% catheter room due to understaffed catheter room or fear of allergy et al. Currently, there is controversy about the duration of antibiotic prophylaxis after implantation, and evidence is lacked on duration of antibiotic prophylaxis after implantation. A small size study in India compared using antibiotics for 2 days (n = 88) and for 7 days (n = 90) after surgery.[16] After 9 months of follow-up, the two groups had equivalent effects. A randomized cluster crossover trial – the Prevention of Arrhythmia Device Infection Trial is now underway and will come to a conclusion soon.[17] Most foreign centers use one single dose of antibiotics before implantation with no longer use after implantation. Studies in surgical area showed that single dose of antibiotics before surgery had equivalent efficacy compared with continuous use of antibiotics after surgery.[15] In our survey, most centers use antibiotics no longer than 72 h with 13.5% centers longer than 72 h. In our survey, there were only 10 centers (7.9%) using one dose of antibiotics within 2 h before implantation, and further prospective studies are warranted to generalize this practice. Studies on duration of use of antibiotic prophylaxis is not only in favor of preventing pacemaker infection but also helps to avoid the misuse of antibiotics to prevent side effects caused by long-term use of antibiotics.

Use of intra-pocket antibiotics

There is no randomized controlled clinical trial on whether pocket washing with antibiotics could reduce pocket infection rate. Gentamicin is against Gram-negative bacteria and part of Gram-positive bacteria. A study in China including 118 patients who were divided into antibiotic washing pockets group and saline washing pockets group followed up for 7 years and found washing pocket with antibiotics had no effect on pocket infection during peri-implantation period. In our survey, 35.6% centers used gentamicin solution for pocket washing while 6 centers with implantation volume more than 500 did not wash pocket with antibiotics at all.


  Conclusion Top


At present, in majority of the hospitals prophylactic antibiotics are used before implantation and β-lactam antibiotics for a broad antibacterial spectrum is selected which covering S. aureus. Significant heterogeneity exists regarding timing and antibiotic regimens used. Further prospective and randomized studies are required to determine the duration of antibiotics regimens.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Bluhm G, Jacobson B, Julander I, Levander-Lindgren M, Olin C. Antibiotic prophylaxis in pacemaker surgery – A prospective study. Scand J Thorac Cardiovasc Surg 1984;18:227-34.  Back to cited text no. 4
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Bluhm G, Nordlander R, Ransjö U. Antibiotic prophylaxis in pacemaker surgery: A prospective double blind trial with systemic administration of antibiotic versus placebo at implantation of cardiac pacemakers. Pacing Clin Electrophysiol 1986;9:720-6.  Back to cited text no. 9
    
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Ramsdale DR, Charles RG, Rowlands DB, Singh SS, Gautam PC, Faragher EB, et al. Antibiotic prophylaxis for pacemaker implantation: A prospective randomized trial. Pacing Clin Electrophysiol 1984;7:844-9.  Back to cited text no. 10
    
11.
Da Costa A, Kirkorian G, Cucherat M, Delahaye F, Chevalier P, Cerisier A, et al. Antibiotic prophylaxis for permanent pacemaker implantation: A meta-analysis. Circulation 1998;97:1796-801.  Back to cited text no. 11
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Klug D, Balde M, Pavin D, Hidden-Lucet F, Clementy J, Sadoul N, et al. Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators: Results of a large prospective study. Circulation 2007;116:1349-55.  Back to cited text no. 12
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de Oliveira JC, Martinelli M, Nishioka SA, Varejão T, Uipe D, Pedrosa AA, et al. Efficacy of antibiotic prophylaxis before the implantation of pacemakers and cardioverter-defibrillators: Results of a large, prospective, randomized, double-blinded, placebo-controlled trial. Circ Arrhythm Electrophysiol 2009;2:29-34.  Back to cited text no. 13
    
14.
Da Costa A, Lelièvre H, Kirkorian G, Célard M, Chevalier P, Vandenesch F, et al. Role of the preaxillary flora in pacemaker infections: A prospective study. Circulation 1998;97:1791-5.  Back to cited text no. 14
    
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Classen DC, Evans RS, Pestotnik SL, Horn SD, Menlove RL, Burke JP, et al. The timing of prophylactic administration of antibiotics and the risk of surgical-wound infection. N Engl J Med 1992;326:281-6.  Back to cited text no. 15
    
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Connolly SJ, Philippon F, Longtin Y, Casanova A, Birnie DH, Exner DV, et al. Randomized cluster crossover trials for reliable, efficient, comparative effectiveness testing: Design of the Prevention of Arrhythmia Device Infection Trial (PADIT). Can J Cardiol 2013;29:652-8.  Back to cited text no. 17
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9], [Figure 10], [Figure 11]



 

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