Bienert I - AIMRADIAL 2015 - Exposure
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Randomized comparison of radiological exposure with TRIPTable in patients with acute coronary syndromes
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Bienert I - AIMRADIAL 2015 - Exposure
- 1. FAMEMA - Marilia State School of Medicine Marília / São Paulo – Brazil Igor Bienert, Pedro Beraldo, Fabio Rinaldi, FernandaVilela, Paulo Silva, Joao Braga, PauloWaib,Alexandre Rodrigues, Fábio Filho, Katashi Okoshi AimRADIAL 2015 UK-MASTERCLASS 2015 Liverpool - United Kingdom
- 2. The authors are the developers and patent owners of the evaluated device (TRIPTable -TRansradial Intervention ProtectionTable) TheTRIPTable device is currently not commercially available or in production line
- 3. TR have progressively increased due to improved patient comfort, lower complication rates and reduced mortality in some scenarios One area of interest is radiation exposure and ways of minimising it. The paucity of quality, randomised data in the literature has confounded efforts to identify trends in exposure associated with theTR access, especially as independent predictor Most studies focus on patient risk with conflicting results
- 4. TR Equal n Achenbach et al (Achenbach & Ropers et al., 2008) 310 Pancholy et al (Pancholy & Joshi et al., 2015) 1919 8255 2229 TR Higher TR EqualTR Higher n Brueck et al(Brueck & Bandorski et al., 2009) 1024 Jolly et al(Jolly & Niemela et al., 2011) 7021 Lange et al(Langeevon Boetticher, 2012) 210 Randomized studies - Fluoroscopy 1024 2436 TR Higher TR Equal Randomized studies - DAP Radiation exposure to the patient remains far below the threshold for deterministic effects
- 5. 423 1050 TR Higher TR Equal TR Higher n Michaelⱡ (Michael & Alomar et al., 2013) 126 Lange* (Langeevon Boetticher, 2006) 195 Lange* (Langeevon Boetticher, 2006) 102 TR Equal n Pancholy et alⱡ (Pancholy & Joshi et al., 2015) 996 Michaelⱡ (Michael & Alomar et al., 2013) 54 Randomized studies - Dosimetry
- 6. The objective of this study is to analyse the differences in radiation impact to the operator and patient during interventional cardiology procedures Aimed at developing and testing radioprotective device specifically for the radial technique in a critical real world scenario
- 7. Pre-clinical data Controled radiological field test Operator position Scattered radiation mapping Levels of radiation – gonads, eye, thyroid Sideboard Drape concept X-ray blocking Device support for therapeutic procedures Puncture standardization Positioning Patient confort
- 8. TRIPTableTrial Development Isodose Curves Radiation lines mapping Prototype development Clinical Trial Femoral Radial (right) TRIPTable Outcomes Inclusion ACS patients Randomization 1:1:1 Statistical analisys External validation (Hawthorn effect) RESULTS Dosimetry - Eye - Thyroid - Gonads Exposure - Fluoroscopy - AK - DAP Patent request and Trial registry (NCT02200783)
- 9. 0 2000 4000 6000 8000 10000 12000 14000 16000 Femoral Radial TRIPTable RAO 30 LAO 30 Caudal 30 Cranial 30 0/0 Technique Radiation impact (mSv/h) Femoral 10522,2 Radial 14041,7 (+33,5% TF) TRIPTable 6696,2 (- 52,3% TR) mSv/h
- 10. Procedure ARISE TRIPTable P-value Only coronary angiography Dye volume (ml) 90,3 ± 18,7 97,9 ± 16,2 0,10 Total duration (min) 13,1 ± 3,19 12,9 ± 4,76 0,90 Fluoroscopy time (min) 2,35 ± 1,09 2,62 ± 1,62 0,54 CA plus PCI ad hoc Dye volume (ml) 174,0 ± 37,0 195,8 ± 49,4 0,06 Total duration (min) 37,3 ± 13,1 37,1 ± 16,6 0,93 Fluoroscopy time (min) 10,3 ± 6,52 9,45 ± 6,43 0,48
- 11. Clinical characteristics Femoral (n:36) Radial (n:36) TRIPTable (n:36) p-value Female 15 (41,7) 17 (47,2) 13 (36,1) 0,63 Age (years) 59,1 ± 14,2 61,3 ± 13,7 63,9 ± 12,5 0,31 BMI (kg/m2) 28,6 ± 3,50 27,1 ± 5,20 27,3 ± 4,40 0,29 Hypertension 31 (86,1) 29 (80,6) 30 (83,3) 0,82 Diabetes mellitus 17 (47,2) 15 (41,7) 12 (33,3) 0,48 Dyslipidemia 12 (33,3) 15 (41,7) 19 (52,8) 0,25 Smoking 8 (22,2) 7 (19,4) 8 (22,2) 0,87 Previous PCI 3 (8,33) 1 (2,78) 5 (13,9) 0,23 Chronic renal failure 6 (16,7) 3 (8,33) 4 (11,1) 0,54 Pheriferal arterial disease 5 (13,9) 3 (8,33) 3 (8,33) 0,66 Non-ST ACS 33 (91,7) 27 (75,0) 33 (91,7) 0,06 ST AMI 3 (8,33) 9 (25,0) 3 (8,33) 0,06 Number of vessels > 70% 0,90 ± 1,10 1,10 ± 1,10 0,80 ± 0,90 0,76 LV ejection fraction (%) 0,58 ± 0,13 0,59 ± 0,13 0,60 ± 0,10 0,84
- 12. Therapeutic procedures (PCI) Femoral (n:14) Radial (n=13) TRIPTable (n=11) p-valor Stents deployed 1,10 ± 0,50 1,20 ± 0,60 1,00 ± 0,00 0,82 Stent diameter (mm) 3,30 ± 0,50 3,20 ± 0,40 3,30 ± 0,40 0,70 Stents lenght (mm) 29,9 ± 16,3 32,5 ± 15,4 29,0 ± 13,4 0,82 Angiographic success rate (%) 14 (100) 12 (92,3) 11 (100) 0,36 Procedure success rate (%) 14 (100) 12 (92,3) 11 (100) 0,36 Complications (%) Femoral (n:36) Radial (n:36) TRIPTable (n:36) p-value Bleeding complications Bruise or hematoma < 5cm 4 (11,1) 2 (5,55) 1 (2,77) 0,34 Hematoma > 5cm 3 (8,33) 1 (2,77) 1 (2,77) 0,43 Severe bleeding (BARC) 0 (0,00) 1 (2,77) 0 (0,00) 0,36 Stent thrombosis (ARC) Acute 0 (0,00) 0 (0,00) 0 (0,00) - Subacute 0 (0,00) 1 (2,77) 0 (0,00) 0,36 Cardiovascular death 0 (0,00) 1 (2,77) 0 (0,00) 0,36 In-hospital death 0 (0,00) 2 (5,55) 0 (0,00) 0,13
- 13. 0 2 4 6 8 10 12 14 Femoral Radial TripTable Gonads Thyroid Eye Technique Radiation impact (mSv) Radial + 18,8% TF TRIPTable - 45,4% TR / - 18,8% TF Radiological impact (mSv) Femoral (n:36) Radial (n:36) TRIPTable (n:36) TLD for each site Eye 1,76 1,34 1,54 Thyroid 2,50 2,77 1,96 Gonads 5,85 8,34 3,30 Total accumulated impact 10,11 12,45 6,80
- 14. Exposure correlation (TLD/AK – mSv/Gy) Eye (n=108) Thyroid (n=108) Gonad (n=108) p-value Radial 0,05 ± 0,02 0,12 ± 0,06 0,33 ± 0,11 Eye, thyroid, gonad <0,01 Eye, thyroid 0,27 Thyroid, gonad <0,01 Eye, gonad <0,01 Femoral 0,07 ± 0,02 0,11 ± 0,13 0,23 ± 0,04 Eye, thyroid, gonad 0,40 Eye, thyroid 0,46 Thyroid, gonad 0,06 Eye, gonad 0,02 TRIPTable 0,08 ± 0,03 0,13 ± 0,08 0,18 ± 0,08 Eye, thyroid, gonad 0,18 Eye, thyroid 0,35 Thyroid, gonad 0,32 Eye, gonad 0,07 expressed as mean ± standard deviation * * * *
- 15. 0 10 20 30 40 50 60 70 80 90 Proceduretime(min) Femoral Radial TripTable 50 100 150 200 250 300 350 400 Contrastvolume(mL) Femoral Radial TripTable Total procedure time Total dye volume Kruskal-Wallis 3 groups test
- 16. 0 5 10 15 20 25 30 Fluoroscopytime(min) Femoral Radial TripTable Fluoroscopy time Kruskal-Wallis 3 groups test
- 17. 0 50000 100000 150000 200000 250000 300000 350000 Doseareaproduct(mGy*cm2) Femoral Radial TripTable 0 500 1000 1500 2000 2500 3000 3500 4000 4500 AirKerma(mGy) Femoral Radial TripTable Dose Area Product Air Kerma Kruskal-Wallis 3 groups test
- 18. In experienced operators hands there was no difference in patient exposure betweenTR vsTF vsTRIPTable There were no differences regarding the technical complexity or success parameters The accumulated radiation showed an increase in operator impact usingTR (+18.8%) compared toTF, mainly derived from gonads In our study the device reduced the radiation received by operator in 45.4% in relation toTR and 18.8% when compared toTF (similar to the preclinical test)
- 19. Single-center First-in-man study External validation Naturally heterogeneous population Prototype device
- 20. Thank you The authors wish to express their gratitude to Professor Paulo Craveiro of the physics and radiotherapy department (in memoriam), who was unrestrictedly helpful and offered invaluable assistance, support and guidance.The authors are deeply saddened by the passing of Professor Paulo Craveiro, a master of the radiation field, and as its discoverers, victim of its harmful effects. His example and his work are the mainstay of this research
Editor's Notes
- Good afternoon, It´s a real pleasure to be here today. My name is Igor Bienert and I'm a professor of medicine in Interventional Cardiology division at FAMEMA in Brazil. I'm delighted to be able to present this study today, and would like to thank professor Olivier Bertrand and congress organization for the gentle invitation. The topic is ionizing radiation, focusing the comparison of radiological exposure between TR and TF techniques, presenting the results of our study testing a protective device prototype that we developed and baptize as TRIPTable
- For first message, I have to declare that the authors are developers and patent owners of the prototype, but as we are a research group and not a industry, it´s not commercially available or in production. Beyond it, I have to confess: I am a convicted radialist. I think it will not be a problem here today.
- The presentation is going to be twofold. First, I will provide some very short introductory comments about current evidence and questions unaswered that based our research, and second, I will talk about the trial itself TR access has been a breakthrough technique in interventional cardiology. We know it. However, there are still a concern about an association between TR catheterisation and increased radiation exposure to both operator and patient, demonstrated in some studies. In this scenario we think some research is still apropriate, not only to define the real radiological impact of the TR technique but also to find ways to reduce it.
- Looking for patient exposure, a difficult is that the majority of data available is not randomized, most are observational and some retrospective. Here I show data from the randomized studies focusing on patient radiation exposure, divided in two categories of analisys: fluoroscopy and DAP. It´s not difficult to see the lack of consensus. A interesting point is that all studies showed a radiation exposure far below the threshold for tissue reaction, demonstrating the security of TR technique
- In this slide I took some of the available data of operator exposure from the review of Professor Eugene Park, recently published in Eurointervention and added the data from the excellent REVERE study published in JACC interventions last july. We can see the divergence among publications but most of it demonstrating equivalence of both TR and TF techniques, mainly driven from the REVERE results. We noted that all the described studies used the a single personal dosimeter as total radiation prerogative. Although it is the usual practice in catheterization laboratories, our preclinical data demonstrate that radiation varies greatly, especially in radiosensitive points as eyes, thyroid and gonads. This aspect will be detailed later
- The objectives of the study were to (1) evaluate the differences in radiation impact for the operator and patient comparing TR and TF procedures and (2) develop and test a device designed to TR radioprotection Many protections boards, drapes and extension devices allowed a reduction in operator exposure, but it´s not yet widely used and some of them do not have clinical evidence. So, we started in the basic research with a phantom to map radiation lines, especially scattered radiation
- This is the device that we developed. A prototype with embed radioprotection projected to act as sideboard and drape like shield, and also to support TR intervention hardware. Beyond radio blocking, the device is also designed to force the operator positioning during the procedure. We believe that´s a tricky point, specially when we talk about learning curve. In preclinical tests the results showed a radiation reduction of about 50% just increasing 30 cm the distance from operator to source.
- This is the TRIPTable study design. In the preclinical phase at first we got the isodose curve, mapping the beam and scattered radiation routes and how it could be blocked without interfere in the fluoroscopy view. The full results of the preclinical test were published recently in BMJ Innovations After the initial data we developed the clinical phase, a prospective randomized 3 group trial, with high volume operators testing TR, TF and the device, using full set of personal radiation protection (including upper and lower table shields) and using TLD in three different sites of radioimpact interest (eye, thyroid and gonads). I'd like to interject that this trial has as inclusion criteria basically ACS patients, including ST elevation AMI, sequentially included aiming to take the worst possible scenario to test the techniques and a possible device protection in a intention-to-treat analysis. We searched for patient direct exposure data as well as operator accumulated exposure. Also, we registered clinical data, technical aspects and MACCE.
- Here´s a summary of preclinical test results. The radiation rate was increased when we moved from femoral to radial (in mSV per hour) and the TRIPTable device reduced operator radiation exposure under controlled simulation when compared to both techniques.
- It's a well-described phenomenon the Hawthorne effect, in which individuals modify their behavior in response to their awareness of being observed. As it would be impossible to blind operators to each technique we compared our results to a database from another clinical trial, the ARISE study, previously presented by professor Pedro Beraldo with almost similar inclusion and exclusion criteria. In this external study the operators were not aware of radiation objective, and the results showed no significant differences.
- Our results showed very homogeneous groups, the majority of patients being admitted as non ST ACS. Despite the high clinical risk, with an median age around 60 years and about a third of diabetic patients, the groups showed no angiographic high-risk, most of them single-vessel disease and with LV relatively well preserved. There were no significant differences among groups, however there was a trend towards more ST elevation patients in TR group.
- As technical results, again there were no differences among groups when we analyze stent characteristics and success rate. Looking for complications, there were no differences in bleeding, stent thrombosis or death. We remember here that the study was not designed to evaluate clinical outcomes. We just registered it
- The primary outcome assessing the risk to the operator demonstrated a increased radiation impact, slightly lower than 19% when we used radial access. As we look more closely we see that the most of the impact was driven by the gonad site, and there were very little difference when we look at thyroid and eye. Interestingly, the eye site received more radiation in TF group. When we take out the gonad site from analysis, there is almost no difference. This findings could help to put in perspective the lack of consensus in literature. In our review, all of the randomized studies described before placed the TLD in the breast pocket or in left arm The TRIPTable device reduced the radiation exposure in 45% as compared to TR technique and almost 19% when compared to TF. Again the results were driven by reduction in gonad impact.
- In a sensibility rate analysis we can see differences on radiation impact. All techniques demonstrated a higher impact in gonad, but when we calculate the impact for exposure ratio, we get a direct relationship of the total amount of ionizing radiation we get when we step on pedal. Comparing the groups, the difference of radiation sites reached statistical signficance in the radial group, the gonads receiving more impact than any other place. For TF this was true only in post hoc analisys, when compared eye and gonads. In the TRIPTable group, there was no significant difference.
- Now we switch for secondary outcomes, looking at patient security. In this boxplot showing the 3 groups we can see there was no difference in procedure time (we have a median about 15 minutes) or dye volume (about 110mL)
- Looking for the patient radiation exposure, again there were no difference in fluoroscopy time (around 3 minutes)
- Neither we saw difference in direct exposure, as we see in the graphics comparing Dose Area Product and Air Kerma.
- In conclusion, our study demonstrate no difference among TR, TF and TRIPTable in technical parameters, success rate, complications or patient exposure to ionizing radiation. A significant increase in operator radiation exposure of about 20% was found whit TR technique compared to TF technique, but only when we look for the gonad site. When we analyze only thyroid and eye there are virtually no difference. The device reduced in 45% the accumulated radiation as compared to TR technique and almost 20% when we compare to TF technique, this findings very similar to preclinical test. Radiation at gonads are described to have mainly heritable effects, so it´s difficult to evaluate the impact in therms of a whole carrier exposure.
- The study limitations should be highlighted. This is a single center study and first-in-man study. Although we made efforts to exclude observer bias, external validation are strongly recommended before further conclusions may be drawn. Also, after the initial clinical test, a study in more predictive daily basis rotine should help in reducing the inherent heterogeneity found in our acute population and the consequent variability found in the statistical analysis The device is not and it is not intended to be a definitive answer. We think that it brings up the issue, around the cath lab to take a different look about ionizing radiation and maybe it could generate new questions and more research. And maybe it could remember us all of the ALARA principle.
- And here I give thanks for your attention and would like to remind in memoriam Professor Craveiro, who contributed immensely in research and passed away just a few months ago due to pulmonary complications of radiation exposure. His example and his work are the mainstay of this research and reminds me of the ALARA principle every day. Thank you