37 results on '"Ivo Bernat"'
Search Results
2. Distal versus conventional radial access for coronary angiography and intervention: Design and rationale of DISCO RADIAL study
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Maarten A.H. van Leeuwen, Juan F. Iglesias, Gregory A. Sgueglia, Adel Aminian, Vladimir Borovicanin, Ivo Bernat, Shigeru Saito, Irene Barriocanal, Sasko Kedev, Joelle Kefer, Gabriele L. Gasparini, Claudiu Ungureanu, Karim Ratib, Gregor Leibundgut, Marcus Wiemer, B Vandeloo, Zoltán Ruzsa, UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, and UCL - (SLuc) Département cardiovasculaire
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medicine.medical_specialty ,medicine.medical_treatment ,Arteriovenous fistula ,Arterial Occlusive Diseases ,Transradial approach ,Coronary Angiography ,Superiority Trial ,Percutaneous Coronary Intervention ,Forearm ,medicine.artery ,Occlusion ,medicine ,Clinical endpoint ,Humans ,Prospective Studies ,Distal radial access ,Radial artery occlusion ,Radial artery ,Transradial access ,business.industry ,Percutaneous coronary intervention ,medicine.disease ,medicine.anatomical_structure ,Treatment Outcome ,Conventional PCI ,Radial Artery ,Radiology ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background Transradial access (TRA) has become the default access method for coronary diagnostic and interventional procedures. As compared to transfemoral access, TRA has been shown to be safer, cost-effective and more patient-friendly. Radial artery occlusion (RAO) represents the most frequent complication of TRA, and precludes future coronary procedures through the radial artery, the use of the radial artery as a conduit for coronary artery bypass grafting or as arteriovenous fistula for patients on hemodialysis. Recently, distal radial access (DRA) has emerged as a promising alternative to TRA, yielding potential for minimizing the risk of RAO. However, an international multicenter randomized comparison between DRA, and conventional TRA with respect to the rate of RAO is still lacking. Trial Design DISCO RADIAL is a prospective, multicenter, open-label, randomized, controlled, superiority trial. A total of 1300 eligible patients will be randomly allocated to undergo coronary angiography and/or percutaneous coronary intervention (PCI) through DRA or TRA using the 6 Fr Glidesheath Slender sheath introducer. Extended experience with both TRA and DRA is required for operators’ eligibility and optimal evidence-based best practice to reduce RAO systematically implemented by protocol. The primary endpoint is the incidence of forearm RAO assessed by vascular ultrasound at discharge. Several important secondary endpoints will also be assessed, including access-site cross-over, hemostasis time, and access-site related complications. Summary The DISCO RADIAL trial will provide the first large-scale multicenter randomized evidence comparing DRA to TRA in patients scheduled for coronary angiography or PCI with respect to the incidence of RAO at discharge.
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- 2022
3. Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention
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Avtandil Babunashvili, Sunil V. Rao, George Hahalis, Mamas A. Mamas, Gregory A. Sgueglia, Ian C. Gilchrist, Maarten A.H. van Leeuwen, Gilles Montalescot, Mario Gaudino, Marco Valgimigli, Olivier F. Bertrand, Adel Aminian, Antonio Ziakas, Ivo Bernat, Samir Pancholy, Shigeru Saito, Yves Louvard, and James Nolan
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medicine.medical_specialty ,Bypass grafting ,business.industry ,Best practice ,Arteriovenous fistula ,030204 cardiovascular system & hematology ,medicine.disease ,03 medical and health sciences ,0302 clinical medicine ,Diagnostic angiography ,medicine.artery ,Intervention (counseling) ,Occlusion ,medicine ,In patient ,030212 general & internal medicine ,Radial artery ,Cardiology and Cardiovascular Medicine ,Intensive care medicine ,business - Abstract
Highlights •RAO remains the most frequent post-procedural complication of transradial access, restricting the use of the same radial artery for future procedures, as a conduit for coronary artery bypass grafting or for arteriovenous fistula creation in patients requiring hemodialysis. •The real-world reported incidence of RAO remains high, with wide variability in the uptake of RAO prevention strategies. •The paper reviews the main recent advances in the field of RAO prevention and provides a series of expert recommendations to prevent RAO. •This consensus document is meant to provide guidance to increase the adoption of simple and effective methods to achieve an institutional rate of RAO
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- 2019
4. (Working in the cathlab during COVID-19 pandemic)
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Tomas Kovarnik, Petr Kmoníček, Michael Želízko, Ivo Varvařovský, Ivo Bernat, Marian Branny, David Horák, Viktor Kočka, Josef Šťásek, Petr Kala, Pavel Červinka, Martin Mates, and Ladislav Pešl
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03 medical and health sciences ,2019-20 coronavirus outbreak ,0302 clinical medicine ,Coronavirus disease 2019 (COVID-19) ,business.industry ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Medicine ,030212 general & internal medicine ,030204 cardiovascular system & hematology ,Cardiology and Cardiovascular Medicine ,business ,Virology - Abstract
ný clanek představuje přistup Ceske asociace intervencni kardiologie k invazivni lecbě srdecnich onemocněni během koronavirove pandemie. Primarni angioplastika zůstava metodou volby pro lecbu pacientů s infarktem myokardu s elevacemi useku ST (STEMI) i pro nemocne s infarktem myokardu be elevaci useku ST (NSTEMI) a trvajici ischemii, bez ohledu na znalost přitomnosti koronaviru u těchto pacientů v době výkonu. Ostatni nemocni, kteři potřebuji katetrizacni lecbu srdecni nemoci, by měli být vysetřeni alespoň 48 hodin před přijetim do zdravotnickeho zařizeni na přitomnost COVID-19. Přiznivý průběh pandemie v Ceske republice umožňuje v soucasnosti katetrizacnim laboratořim postupný navrat k obvykle urovni kvality a dostupnosti invazivni lecby. © 2020, CKS.
- Published
- 2020
5. A Randomized Trial Comparing Short versus Prolonged Hemostasis with Rescue Recanalization by Ipsilateral Ulnar Artery Compression: Impact on Radial Artery Occlusion—The RESCUE-RAO Trial
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Goar K Arutyunyan, Alexander Sedaghat, Andrey S Tereshchenko, Tatyana Balakhonova, E V Merkulov, Olivier F. Bertrand, O A Pogorelova, Sergey I Provatorov, Dmitrii Ognerubov, M.I. Tripoten, Ivo Bernat, and Anatoliy N Samko
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Male ,medicine.medical_specialty ,Article Subject ,Arterial Occlusive Diseases ,law.invention ,Ulnar Artery ,Percutaneous Coronary Intervention ,Randomized controlled trial ,law ,medicine.artery ,Occlusion ,Catheterization, Peripheral ,Outcome Assessment, Health Care ,medicine ,Plethysmograph ,Humans ,Diseases of the circulatory (Cardiovascular) system ,Radiology, Nuclear Medicine and imaging ,Radial artery ,Ulnar artery ,Vascular Patency ,Ultrasonography, Doppler, Duplex ,Duration of Therapy ,business.industry ,Hemostatic Techniques ,Middle Aged ,Surgery ,Plethysmography ,Hemostasis ,RC666-701 ,Conventional PCI ,Radial Artery ,Female ,Cardiology and Cardiovascular Medicine ,business ,Bandage ,Research Article - Abstract
Background. Despite the enormous benefits of radial access, this route is associated with a risk of radial artery occlusion (RAO). Objective. We compared the incidence of RAO in patients undergoing transradial coronary angiography and intervention after short versus prolonged hemostasis protocol. Also we assessed the efficacy of rescue 1-hour ipsilateral ulnar artery compression if RAO was observed after hemostasis. Material and Methods. Patients referred for elective transradial coronary procedures were eligible. After 6 F radial sheath removal, patients were randomized to short (3 hours) (n = 495) or prolonged (8 hours) (n = 503) hemostasis and a simple bandage was placed over the puncture site. After hemostasis was completed, oximetry plethysmography was used to assess the patency of the radial artery. Results. One thousand patients were randomized. Baseline characteristics were similar between both groups with average age 61.4 ± 9.4 years (71% male) and PCI performed on half of the patients. The RAO rate immediately after hemostasis was 3.2% in the short hemostasis group and 10.1% in the prolonged group ( p < 0.001 ). Rescue recanalization was successful only in the short group in 56.2% (11/19); at hospital discharge, RAO rates were 1.4% in the short group and 10.1% in the prolonged group ( p < 0.001 ). Conclusion. Shorter hemostasis was associated with significantly less RAO compared to prolonged hemostasis. Rescue radial artery recanalization was effective in > 50%, but only in the short hemostasis group.
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- 2020
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6. Ultimate Less Radial Artery Occlusion Hemostasis Method on Slender PCI
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Ivo Bernat
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medicine.medical_specialty ,business.industry ,fungi ,Less invasive ,food and beverages ,Surgery ,Hemostasis ,medicine.artery ,Occlusion ,Conventional PCI ,Medicine ,Radial artery ,business ,Compression time - Abstract
Postprocedural radial artery occlusion (RAO) can be minimized mainly by slender less invasive approach, adequate anticoagulation and optimal postprocedural care which should be started immediately after transradial procedure in catheterization laboratory. With simple hemostasis protocol described in this chapter the risk of early RAO can be reduced below 1%.
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- 2020
7. Thrombus Aspiration in Patients With High Thrombus Burden in the TOTAL Trial
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Asim N. Cheema, Vladimír Džavík, Shamir R. Mehta, Warren J. Cantor, John A. Cairns, James L. Velianou, Raul Moreno, Sasko Kedev, Total Investigators, Brandi Meeks, Matthew Sibbald, Tej Sheth, Sunil V. Rao, Shahar Lavi, Michael Tsang, Goran Stankovic, Sanjit S. Jolly, Ivo Bernat, Peggy Gao, and Saqib Chowdhary
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medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Cardiogenic shock ,Hazard ratio ,Percutaneous coronary intervention ,Thrombolysis ,030204 cardiovascular system & hematology ,medicine.disease ,3. Good health ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Conventional PCI ,cardiovascular system ,medicine ,Cardiology ,cardiovascular diseases ,030212 general & internal medicine ,Myocardial infarction ,Thrombus ,Cardiology and Cardiovascular Medicine ,business ,Stroke ,circulatory and respiratory physiology - Abstract
Background Routine thrombus aspiration in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) does not improve clinical outcomes. However, there is remaining uncertainty about the potential benefit in those patients with high thrombus burden, where there is a biological rationale for greater benefit. Objectives The purpose of this study was to evaluate the benefit of thrombus aspiration among STEMI patients with high thrombus burden. Methods TOTAL (ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI) was a randomized trial of routine manual thrombectomy versus PCI alone in patients with STEMI (n = 10,732). High thrombus burden (Thrombolysis In Myocardial Infarction thrombus grade ≥3) was a pre-specified subgroup. Results The primary outcome of cardiovascular (CV) death, MI, cardiogenic shock, or heart failure was not different at 1 year with thrombus aspiration in patients with high thrombus burden (8.1% vs. 8.3% thrombus aspiration; hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.84 to 1.13) or low thrombus burden (6.0% vs. 5.0% thrombus aspiration; HR: 1.22; 95% CI: 0.73 to 2.05; interaction p = 0.41). However, among patients with high thrombus burden, stroke at 30 days was more frequent with thrombus aspiration (31 [0.7%] thrombus aspiration vs. 16 [0.4%] PCI alone, HR: 1.90; 95% CI: 1.04 to 3.48). In the high thrombus burden group, thrombus aspiration did not significantly improve CV mortality at 30 days (HR: 0.78; 95% CI: 0.61 to 1.01; p = 0.06) and at 1 year (HR: 0.88; 95% CI: 0.72 to 1.09; p = 0.25). Irrespective of treatment assignment, high thrombus burden was an independent predictor of death (HR: 1.78; 95% CI: 1.05 to 3.01). Conclusions In patients with high thrombus burden, routine thrombus aspiration did not improve outcomes at 1 year and was associated with an increased rate of stroke. High thrombus burden is still an important predictor of outcome in STEMI. (A Trial of routine aspiration ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI [TOTAL]; NCT01149044)
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- 2018
8. Patent hemostasis and comparison of two compression devices after transradial coronary catheterization and intervention
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Jan Duršpek, Štěpán Jirouš, Ivo Bernat, and Richard Rokyta
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03 medical and health sciences ,0302 clinical medicine ,business.industry ,Hemostasis ,Anesthesia ,Medicine ,030212 general & internal medicine ,030204 cardiovascular system & hematology ,Cardiology and Cardiovascular Medicine ,business ,Nuclear medicine - Abstract
Cil: Cilem prace bylo porovnat dva kompresni prostředky po transradialni koronarni katetrizaci a intervenci.Metody: Z konsekutivně zařazených 280 pacientů, katetrizovaných a intervenovaných (n = 74) v programu jednodenni hospitalizace, jich mělo 140 komprimovano radialni tepnu po výkonu pomoci kompresniho prostředku TR Band (TB) a 140 pomoci prostředku Seal-One (SO). Hodnotili jsme dobu potřebnou k dosaženi perfuzni hemostazy, celkovou dobu komprese a lokalni komplikace.Výsledky: Perfuzni hemostaza v TB skupině byla dosažena za 17,5 ± 10,3 min, ve skupině SO za 21,4 ± 10,5 min (p = NS). Celkova doba komprese radialni tepny dosahovala ve skupině TB 90,7 ± 38,4 min a ve skupině SO 64,0 ± 26,5 min (p < 0,001). Výskyt hematomů ≥ 5 cm byl v obou skupinach stejný (6,4 % vs. 6,4 %, p = NS), výskyt hematomů nad 10 cm byl ve skupině TB 0,7 % a ve skupině SO 1,4 % (p = NS). V obou skupinach nebyly prokazany žadný uzavěr radialni tepny ani dalsi lokalni komplikace při propustěni.Zavěr: Komprese radialni tepny pomoci prostředků TR Band a Seal-One je spojena s casným dosaženim perfuzni hemostazy a kratkou celkovou dobou komprese. Průměrna doba komprese prostředkem Seal-One byla v nasi studii kratsi. Komprese radialni tepny po výkonu nebyla spojena s výskytem uzavěru radialni tepny při propustěni ani dalsimi lokalnimi komplikacemi kromě nizkeho výskytu klinicky nezavažných hematomů.
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- 2018
9. Distal Radial Approach
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Ivo Bernat
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medicine.medical_specialty ,Invasive strategy ,business.industry ,Medicine ,Radiology ,Cardiology and Cardiovascular Medicine ,business - Published
- 2021
10. Prevention of Radial Artery Occlusion After Transradial Catheterization
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Tejas Patel, Ivo Bernat, Olivier F. Bertrand, and Samir Pancholy
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medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Surgery ,Transradial catheterization ,03 medical and health sciences ,0302 clinical medicine ,Hemostasis ,medicine.artery ,Occlusion ,Clinical endpoint ,medicine ,Radial artery ,Cardiology and Cardiovascular Medicine ,Complication ,business ,030217 neurology & neurosurgery ,Ulnar artery ,Cardiac catheterization - Abstract
Objectives The study sought to evaluate whether prophylactic ipsilateral ulnar artery compression during radial artery hemostasis could reduce the risk of radial artery occlusion (RAO). Background RAO after transradial access (TRA) is a structural complication of TRA. It limits future ipsilateral TRA and may cause transient pain. Maintaining radial artery flow during hemostasis reduces the incidence of acute RAO. Ipsilateral ulnar compression increases radial artery flow and could impact the incidence of RAO. Methods Three thousand patients undergoing diagnostic cardiac catheterization using TRA were randomized to receive either standard patent hemostasis protocol (Group I) or prophylactic ipsilateral ulnar compression in addition to patent hemostasis (Group II). Using plethysmography, radial artery patency was evaluated at the time of removal of the compression device as well as 24 h and 30 days after the procedure. The primary study endpoint was 30-day RAO. Results The primary endpoint, 30-day RAO, was significantly reduced in patients with patent hemostasis and prophylactic ulnar compression compared with standard patent hemostasis (0.9% vs. 3.0%; p = 0.0001). Baseline patient and procedural characteristics were similar between the 2 groups. RAO was significantly reduced by prophylactic ulnar compression at all time intervals (p Conclusions Prophylactic ipsilateral ulnar compression during radial artery hemostasis is an effective, simple, and inexpensive technique that lowers the risk of RAO after TRA.
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- 2016
11. Access-site bleeding and radial artery occlusion in transradial primary percutaneous coronary intervention
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Eva Dragounová, Milan Hromádka, Štěpán Jirouš, Ivo Bernat, Pavlína Tůmová, Richard Rokyta, Vratislav Pechman, and Jitka Seidlerová
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Male ,Ticagrelor ,medicine.medical_specialty ,Adenosine ,Ticlopidine ,Time Factors ,Prasugrel ,Abciximab ,medicine.medical_treatment ,Hemorrhage ,Platelet Glycoprotein GPIIb-IIIa Complex ,Punctures ,030204 cardiovascular system & hematology ,Immunoglobulin Fab Fragments ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Risk Factors ,Internal medicine ,Catheterization, Peripheral ,medicine ,Humans ,030212 general & internal medicine ,Aged ,Hematoma ,Prasugrel Hydrochloride ,Hemostatic Techniques ,business.industry ,Antibodies, Monoclonal ,Percutaneous coronary intervention ,General Medicine ,Middle Aged ,Clopidogrel ,Treatment Outcome ,Radial Artery ,Purinergic P2Y Receptor Antagonists ,Cardiology ,ST Elevation Myocardial Infarction ,Platelet aggregation inhibitor ,Female ,Cardiology and Cardiovascular Medicine ,business ,Platelet Aggregation Inhibitors ,medicine.drug - Abstract
BACKGROUND The aim of this study was to evaluate access-site complications in patients with ST-segment elevation myocardial infarction treated with a transradial primary percutaneous coronary intervention relative to three different P2Y12 platelet inhibitors. PATIENTS AND METHODS We enrolled 334 consecutive patients (76.9% men, age: 59.4±9.1 years) treated by one of the following: clopidogrel (n=118), prasugrel (n=102), and ticagrelor (n=114). The use of the IIb/IIIa inhibitor, abciximab, was left to the operators' discretion. The time needed to achieve patent hemostasis, compression time, and local complications were analyzed. RESULTS The baseline characteristics were similar in all three P2Y12 platelet inhibitor groups. Abciximab was used in 72 (21.6%) patients. Administration of abciximab was associated with a higher incidence of grade II and III hematomas (23.6 vs. 5.0%, P
- Published
- 2016
12. What is the optimal strategy of prehospital pretreatment of STEMI patients with P2Y12 inhibitors?
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Eva Dragounová, Ondřej Sirotek, Roman Sviták, Milan Hromádka, Kristýna Junková, Ivo Bernat, Vratislav Pechman, and Richard Rokyta
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medicine.medical_specialty ,business.industry ,Urology ,medicine ,Cardiology and Cardiovascular Medicine ,Critical Care and Intensive Care Medicine ,business ,Ticagrelor ,medicine.drug - Abstract
2Zdravotnicka zachranna služba Plzeňskeho kraje 3ARO Mulacovy nemocnice, Plzeň Přednemocnicni předleceni STEMI pacientů P2Y12 inhibitory zůstava i v r. 2016 stale kontroverzni otazkou. Na podzim roku 2012 vypracovala Zachranna zdravotnicka služba (ZZS) Plzeňskeho kraje ve spolupraci s Kardiologickým odd. FN Plzeň metodický list na zakladě doporucených postupů ESC pro diagnostiku a lecbu STEMI pacientů z r. 2012. V obdobi 2013–2014 bylo v Plzeňskem kraji ve vozech ZZS předleceno P2Y12 inhibitory teměř 50 % nemocných. Nejcastěji podaným P2Y12 inhibitorem byl ticagrelor.
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- 2016
13. Impact of sheath size and hemostasis time on radial artery patency after transradial coronary angiography and intervention in Japanese and non-Japanese patients: A substudy from RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT) randomized multicenter trial
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Seiji Yamazaki, Akihiko Takahashi, Niels van Royen, Ferdinand Kiemeneij, Juan F. Iglesias, Ivo Bernat, Shigeru Saito, Takashi Matsukage, Maarten A.H. van Leeuwen, Ian C. Gilchrist, Takashi Kajiya, Sunil V. Rao, Adel Aminian, Yves Louvard, Robert Lee Jobe, Cardiology, and ACS - Atherosclerosis & ischemic syndromes
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Male ,Coronary angiography ,Time Factors ,Patient characteristics ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Coronary Angiography ,Cardiac Catheters ,0302 clinical medicine ,Japan ,Risk Factors ,Occlusion ,Single-Blind Method ,Prospective Studies ,030212 general & internal medicine ,Aged, 80 and over ,Incidence ,Vascular damage Radboud Institute for Molecular Life Sciences [Radboudumc 16] ,Equipment Design ,General Medicine ,Middle Aged ,Treatment Outcome ,Radial Artery ,Cardiology ,Population study ,Female ,Cardiology and Cardiovascular Medicine ,medicine.medical_specialty ,Arterial Occlusive Diseases ,Hemorrhage ,03 medical and health sciences ,Percutaneous Coronary Intervention ,All institutes and research themes of the Radboud University Medical Center ,Asian People ,Multicenter trial ,Internal medicine ,medicine.artery ,Catheterization, Peripheral ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Radial artery ,Adverse effect ,Vascular Patency ,Aged ,Hemostasis ,business.industry ,United States ,business - Abstract
Background: During transradial (TR) access, it remains unclear whether differences in baseline patients characteristics and hemostasis care impact the rate of radial artery occlusion (RAO). We sought to compare the rate of RAO after TR access with the 6 French(Fr) Glidesheath Slender (GSS6Fr, Terumo, Japan) or a standard 5 Fr sheath in Japanese and non-Japanese patients. Methods and Results: The Radial Artery Patency and Bleeding, Efficacy, Adverse evenT (RAP and BEAT) trial randomized 1,836 patients undergoing TR coronary angiography and/or interventions to receive the GSS6Fr or the standard 5 Fr Glidesheath (GS5Fr, Terumo, Japan). Out of this study population, 1,087 were Japanese patients and 751 non-Japanese patients. The overall incidence of RAO was significantly higher in Japanese patients (3.6% vs. 1.2%, P = 0.002). Use of GSS6Fr was associated with higher rates of RAO than GS5Fr in Japanese patients (5% vs. 2.2%, P = 0.02) and with similar RAO rates in non-Japanese patients (1.3 vs. 1.1%, P = 1). The mean hemostasis time was significantly longer in Japanese patients (378 ± 253 vs. 159 ± 136 min, P < 0.001) and more Japanese patients had a hemostasis time of more than 6 hr (16.2% vs. 4.9%, P < 0.0001). Longer hemostasis time was an independent predictor of RAO (OR per additional hour 1.070, 95% CI 1.008–1.136, P = 0.03). Conclusions: Use of GSS6Fr was associated with a higher rate of RAO than a standard 5 Fr sheath in Japanese patients but not in non-Japanese patients. Whether improvement in post-procedural care and reduced hemostasis time could impact the incidence of RAO in Japanese patients should be further assessed.
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- 2018
14. European bifurcation club - EBC 2018
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Ivo Bernat
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business.industry ,Medicine ,Cardiology and Cardiovascular Medicine ,Critical Care and Intensive Care Medicine ,business - Published
- 2019
15. Randomized Trial of Primary PCI with or without Routine Manual Thrombectomy
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Sanjit S. Jolly, John A. Cairns, Salim Yusuf, Brandi Meeks, Janice Pogue, Michael J. Rokoss, Sasko Kedev, Lehana Thabane, Goran Stankovic, Raul Moreno, Anthony Gershlick, Saqib Chowdhary, Shahar Lavi, Kari Niemelä, Philippe Gabriel Steg, Ivo Bernat, Yawei Xu, Warren J. Cantor, Christopher B. Overgaard, Christoph K. Naber, Asim N. Cheema, Robert C. Welsh, Olivier F. Bertrand, Alvaro Avezum, Ravinay Bhindi, Samir Pancholy, Sunil V. Rao, Madhu K. Natarajan, Jurriën M. ten Berg, Olga Shestakovska, Peggy Gao, Petr Widimsky, and Vladimír Džavík
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Male ,medicine.medical_specialty ,medicine.medical_treatment ,Myocardial Infarction ,Kaplan-Meier Estimate ,030204 cardiovascular system & hematology ,Revascularization ,law.invention ,Electrocardiography ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Randomized controlled trial ,law ,medicine ,Humans ,cardiovascular diseases ,030212 general & internal medicine ,Stroke ,Aged ,Thrombectomy ,Heart Failure ,business.industry ,Coronary Thrombosis ,Cardiogenic shock ,Hazard ratio ,General Medicine ,Middle Aged ,medicine.disease ,Combined Modality Therapy ,Confidence interval ,3. Good health ,Surgery ,Cardiovascular Diseases ,Heart failure ,Microvessels ,Conventional PCI ,Female ,business - Abstract
The primary outcome occurred in 347 of 5033 patients (6.9%) in the thrombectomy group versus 351 of 5030 patients (7.0%) in the PCI-alone group (hazard ratio in the thrombectomy group, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P = 0.86). The rates of cardiovascular death (3.1% with thrombectomy vs. 3.5% with PCI alone; hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P = 0.34) and the primary outcome plus stent thrombosis or target-vessel revascularization (9.9% vs. 9.8%; hazard ratio, 1.00; 95% CI, 0.89 to 1.14; P = 0.95) were also similar. Stroke within 30 days occurred in 33 patients (0.7%) in the thrombectomy group versus 16 patients (0.3%) in the PCI-alone group (hazard ratio, 2.06; 95% CI, 1.13 to 3.75; P = 0.02). Conclusions In patients with STEMI who were undergoing primary PCI, routine manual thrombectomy, as compared with PCI alone, did not reduce the risk of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA class IV heart failure within 180 days but was associated with an increased rate of stroke within 30 days. (Funded by Medtronic and the Canadian Institutes of Health Research; TOTAL ClinicalTrials.gov number, NCT01149044.)
- Published
- 2015
16. Comparison of a new slender 6 Fr sheath with a standard 5 Fr sheath for transradial coronary angiography and intervention: RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT), a randomised multicentre trial
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Takashi Kajiya, Akihiko Takahashi, Ferdinand Kiemeneij, Adel Aminian, Ian C. Gilchrist, Robert Lee Jobe, Sunil V. Rao, Takashi Matsukage, Ivo Bernat, Shigeru Saito, Seiji Yamazaki, Niels van Royen, and Yves Louvard
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Male ,medicine.medical_specialty ,Cardiac Catheterization ,medicine.medical_treatment ,Arterial Occlusive Diseases ,Hemorrhage ,030204 cardiovascular system & hematology ,Coronary Angiography ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,Randomized controlled trial ,law ,medicine.artery ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,030212 general & internal medicine ,Prospective Studies ,Radial artery ,Adverse effect ,Prospective cohort study ,Vascular Patency ,Cardiac catheterization ,Aged ,business.industry ,Absolute risk reduction ,Vascular damage Radboud Institute for Molecular Life Sciences [Radboudumc 16] ,Percutaneous coronary intervention ,Middle Aged ,Surgery ,Radial Artery ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
Item does not contain fulltext AIMS: The 6 Fr Glidesheath Slender (GSS6Fr) is a recently developed thin-walled radial sheath with an outer diameter (OD) that is smaller than the OD of standard 6 Fr sheaths. The purpose of this trial was to clarify whether the use of this new slender sheath would result in similar rates of RAO to a standard 5 Fr sheath in unselected patients undergoing transradial (TR) coronary angiography and/or intervention, and to assess the relative importance of sheath size and haemostasis protocol on the rate of RAO. METHODS AND RESULTS: We conducted a randomised, multicentre, non-inferiority trial comparing the GSS6Fr against the standard GS5Fr in patients undergoing TR coronary angiography and/or intervention. Patients in each group were subsequently randomised to undergo patent haemostasis or the institutional haemostasis protocol. The primary endpoint was the occurrence of RAO at discharge. A total of 1,926 patients were randomised in 12 centres. The incidence of RAO was 3.47% with GSS6Fr compared with 1.74% with GS5Fr (risk difference 1.73%, 95% CI: 0.51-2.95%; pnon-inferiority=0.150). Patients randomised to patent haemostasis had a similar rate of RAO compared with institutional haemostasis (2.61% vs. 2.61%, p=1). There was no difference with regard to all secondary endpoints, including vascular access-site complications, local bleeding and spasm. CONCLUSIONS: In this large multicentre randomised trial, the GSS6Fr was associated with a low event rate for the primary endpoint (RAO), although non-inferiority to the GS5Fr was not met, due to a lower than expected rate of RAO in the GS5Fr group. As compared to institutional haemostasis, the use of patent haemostasis was not associated with a reduced rate of RAO.
- Published
- 2017
17. ST-Segment Elevation Myocardial Infarction Treated by Radial or Femoral Approach in a Multicenter Randomized Clinical Trial
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Jan Pešek, Abdul Al Mawiri, Pavel Polansky, Zdenek Sembera, Josef Stasek, Jaroslav Dušek, Michal Šmíd, Ondrej Aschermann, Jiri Koza, Olivier Costerousse, Ivo Bernat, Miroslav Brtko, Olivier F. Bertrand, David Horák, Jan Vojáček, Richard Rokyta, Vlado Hrabos, Josef Bis, Martin Mates, and Petr Ostadal
- Subjects
medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Percutaneous coronary intervention ,medicine.disease ,Surgery ,Multicenter trial ,Intensive care ,Conventional PCI ,medicine ,Clinical endpoint ,Cumulative incidence ,Myocardial infarction ,business ,Cardiology and Cardiovascular Medicine ,Stroke - Abstract
Objectives This study sought to compare radial and femoral approaches in patients presenting with ST-segment elevation myocardial infarction (STEMI) and undergoing primary percutaneous coronary intervention (PCI) by high-volume operators experienced in both access sites. Background The exact clinical benefit of the radial compared to the femoral approach remains controversial. Methods STEMI-RADIAL (ST Elevation Myocardial Infarction treated by RADIAL or femoral approach) was a randomized, multicenter trial. A total of 707 patients referred for STEMI
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- 2014
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18. STEMI - The importance of balance between antithrombotic treatment and bleeding risk
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Jan Pospisil, Milan Hromádka, Ivo Bernat, and Richard Rokyta
- Subjects
education.field_of_study ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Incidence (epidemiology) ,Bleeding ,Population ,Percutaneous coronary intervention ,Antithrombotic treatment ,ST elevation myocardial infarction ,surgical procedures, operative ,St elevation myocardial infarction ,Internal medicine ,Conventional PCI ,Antithrombotic ,medicine ,Cardiology ,Anticoagulant Agent ,cardiovascular diseases ,Cardiology and Cardiovascular Medicine ,education ,business - Abstract
The incidence of ST elevation myocardial infarction (STEMI) is around 66 STEMI per 100 000 of population/year, with 6–12% hospital mortality in unselected patients [1] . Modern treatment strategies for STEMI are based on immediate antithrombotic treatment and primary percutaneous coronary intervention (PCI) with stent implantation. Therapy with a combination of two or even three more potent antiplatelet and anticoagulant agents reduces both short-term and long-term ischemic risk, morbidity and mortality; on the other hand it is associated with higher risks of bleeding. The first part of this review is focused on the pathogenesis of thrombi in STEMI patients and antithrombotic drugs currently used to treat STEMI patients. In the second part we discuss several factors that can affect bleeding risks including the choice of access site for coronary angiography, prevention and treatment of bleeding in STEMI patients. Finding a balance which minimizes both thrombotic and bleeding risk is crucial, although, it can be difficult and further randomized studies directed at finding this balance are needed.
- Published
- 2013
19. Same-Day Discharge Compared With Overnight Hospitalization After Uncomplicated Percutaneous Coronary Intervention
- Author
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Ivo Bernat, Sunil V. Rao, Ian C. Gilchrist, Samir Pancholy, Adhir Shroff, Olivier F. Bertrand, Eltigani Abdelaal, Ronald P. Caputo, and Olivier Costerousse
- Subjects
Pediatrics ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Percutaneous coronary intervention ,Cochrane Library ,Confidence interval ,law.invention ,Randomized controlled trial ,law ,Meta-analysis ,Internal medicine ,Conventional PCI ,Medicine ,Observational study ,Cardiology and Cardiovascular Medicine ,business ,Mace - Abstract
Objectives This study sought to evaluate outcomes of same-day discharge (SDD) following percutaneous coronary intervention (PCI) versus overnight hospitalization (ON). Background Although there are data on the safety and feasibility of SDD after PCI, ON continues to be prevalent. Methods The Cochrane search strategy was used to search the PubMed database, EMBASE, and the Cochrane Library for relevant literature. Thirteen studies (5 randomized and 8 observational) of SDD after uncomplicated PCI versus ON met inclusion criteria. Data were pooled using a random effects model, and reported as odds ratios (OR) with their 95% confidence intervals (CI). The primary outcomes were incidence of total complications, major adverse cardiovascular events (MACE), and rehospitalization within 30 days after PCI. Results A total of 13 studies, involving 111,830 patients were pooled. There was significant variation in the definition of outcomes across studies. For total complications, the strategy of SDD compared with ON after PCI had an estimated OR of 1.20 (95% CI: 0.82 to 1.74) in randomized and 0.67 (95% CI: 0.27 to 1.66) in observational studies. Similar results were found for MACE (randomized, OR: 0.99, 95% CI: 0.45 to 2.18; observational, OR: 0.59, 95% CI: 0.06 to 5.57) and rehospitalizations (randomized, OR: 1.10, 95% CI: 0.70 to 1.74; observational, OR: 0.62, 95% CI: 0.10 to 3.98) at 30 days post PCI. Conclusions There is considerable heterogeneity across published studies comparing SDD with ON. This, coupled with the low event rate and wide corresponding CIs, suggest that an adequately powered multicenter randomized trial comparing SDD with ON would require a very large sample size (>17,000). Until such a trial is completed, SDD after uncomplicated PCI seems a reasonable approach in selected patients.
- Published
- 2013
20. Radial Artery Occlusion After Transradial Interventions: A Systematic Review and Meta‐Analysis
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Doug Fraser, Adrian Large, Sasko Kedev, Samir Pancholy, Ivo Bernat, Mamas A. Mamas, James Nolan, Chun Shing Kwok, Muhammad Rashid, Karim Ratib, and Sanjay Kumar Chugh
- Subjects
Male ,vascular complications ,medicine.medical_specialty ,Arterial Occlusive Diseases ,Punctures ,030204 cardiovascular system & hematology ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Risk Factors ,Catheter-Based Coronary and Valvular Interventions ,Internal medicine ,medicine.artery ,Catheterization, Peripheral ,Occlusion ,Odds Ratio ,medicine ,Humans ,030212 general & internal medicine ,Radial artery ,Aged ,Original Research ,Chi-Square Distribution ,Dose-Response Relationship, Drug ,Heparin ,business.industry ,Incidence ,transradial catheterization or access ,Anticoagulants ,radial artery occlusion ,Odds ratio ,Middle Aged ,R1 ,Interventional Cardiology ,Surgery ,Vasoconstriction ,Meta-analysis ,Relative risk ,Hemostasis ,Radial Artery ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business ,Complication ,Chi-squared distribution - Abstract
Background Radial artery occlusion ( RAO ) may occur posttransradial intervention and limits the radial artery as a future access site, thus precluding its use as an arterial conduit. In this study, we investigate the incidence and factors influencing the RAO in the current literature. Methods and Results We searched MEDLINE and EMBASE for studies of RAO in transradial access. Relevant studies were identified and data were extracted. Data were synthesized by meta‐analysis, quantitative pooling, graphical representation, or by narrative synthesis. A total of 66 studies with 31 345 participants were included in the analysis. Incident RAO ranged between RAO within 24 hours was 7.7%, which decreased to 5.5% at >1 week follow‐up). The most efficacious measure in reducing RAO was higher dose of heparin, because lower doses of heparin were associated with increased RAO (risk ratio 0.36, 95% CI 0.17–0.76), whereas shorter compression times also reduced RAO (risk ratio 0.28, 95% CI 0.05–1.50). Several factors were found to be associated with RAO including age, sex, sheath size, and diameter of radial artery, but these factors were not consistent across all studies. Conclusions RAO is a common complication of transradial access. Maintenance of radial patency should be an integral part of all procedures undertaken through the radial approach. High‐dose heparin along with shorter compression times and patent hemostasis is recommended in reducing RAO .
- Published
- 2016
21. Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial
- Author
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Goran Stankovic, Sanjit S. Jolly, Asim N. Cheema, Sunil V. Rao, Madhu K. Natarajan, Brandi Meeks, Alvaro Avezum, Shamir R. Mehta, Anthony H. Gershlick, Magdi El-Omar, John A. Cairns, Michael Rokoss, Olivier F. Bertrand, David Horák, Raul Moreno, Kari Niemelä, Vladimír Džavík, Shahar Lavi, Peggy Gao, James L. Velianou, Robert C. Welsh, Philippe Gabriel Steg, Saleem Kassam, Ivo Bernat, Warren J. Cantor, Saqib Chowdhary, Ravinay Bhindi, Salim Yusuf, Sasko Kedev, R. Leung, Tej Sheth, and Samir Pancholy
- Subjects
Male ,medicine.medical_specialty ,medicine.medical_treatment ,Myocardial Infarction ,030204 cardiovascular system & hematology ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,Randomized controlled trial ,law ,medicine ,Humans ,030212 general & internal medicine ,Myocardial infarction ,cardiovascular diseases ,Prospective Studies ,Prospective cohort study ,Stroke ,Aged ,Thrombectomy ,Heart Failure ,Intention-to-treat analysis ,business.industry ,Cardiogenic shock ,Coronary Thrombosis ,Percutaneous coronary intervention ,Shock ,General Medicine ,medicine.disease ,Combined Modality Therapy ,3. Good health ,Surgery ,surgical procedures, operative ,Cardiovascular Diseases ,Conventional PCI ,cardiovascular system ,Female ,business ,Follow-Up Studies - Abstract
Summary Background Two large trials have reported contradictory results at 1 year after thrombus aspiration in ST elevation myocardial infarction (STEMI). In a 1-year follow-up of the largest randomised trial of thrombus aspiration, we aimed to clarify the longer-term benefits, to help guide clinical practice. Methods The trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL) was a prospective, randomised, investigator-initiated trial of routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone in 10 732 patients with STEMI. Eligible adult patients (aged ≥18 years) from 87 hospitals in 20 countries were enrolled and randomly assigned (1:1) within 12 h of symptom onset to receive routine manual thrombectomy with PCI or PCI alone. Permuted block randomisation (with variable block size) was done by a 24 h computerised central system, and was stratified by centre. Participants and investigators were not masked to treatment assignment. The trial did not show a difference at 180 days in the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure. However, the results showed improvements in the surrogate outcomes of ST segment resolution and distal embolisation, but whether or not this finding would translate into a longer term benefit remained unclear. In this longer-term follow-up of the TOTAL study, we report the results on the primary outcome (cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure) and secondary outcomes at 1 year. Analyses of the primary outcome were by modified intention to treat and only included patients who underwent index PCI. This trial is registered with ClinicalTrials.gov, number NCT01149044. Findings Between Aug 5, 2010, and July 25, 2014, 10 732 eligible patients were enrolled and randomly assigned to thrombectomy followed by PCI (n=5372) or to PCI alone (n=5360). After exclusions of patients who did not undergo PCI in each group (337 in the PCI and thrombectomy group and 331 in the PCI alone group), the final study population comprised 10 064 patients (5035 thrombectomy and 5029 PCI alone). The primary outcome at 1 year occurred in 395 (8%) of 5035 patients in the thrombectomy group compared with 394 (8%) of 5029 in the PCI alone group (hazard ratio [HR] 1·00 [95% CI 0·87–1·15], p=0·99). Cardiovascular death within 1 year occurred in 179 (4%) of the thrombectomy group and in 192 (4%) of 5029 in the PCI alone group (HR 0·93 [95% CI 0·76–1·14], p=0·48). The key safety outcome, stroke within 1 year, occurred in 60 patients (1·2%) in the thrombectomy group compared with 36 (0·7%) in the PCI alone group (HR 1·66 [95% CI 1·10–2·51], p=0·015). Interpretation Routine thrombus aspiration during PCI for STEMI did not reduce longer-term clinical outcomes and might be associated with an increase in stroke. As a result, thrombus aspiration can no longer be recommended as a routine strategy in STEMI. Funding Canadian Institutes of Health Research, Canadian Network and Centre for Trials Internationally, and Medtronic Inc.
- Published
- 2016
22. Meta-Analysis Comparing Bivalirudin Versus Heparin Monotherapy on Ischemic and Bleeding Outcomes After Percutaneous Coronary Intervention
- Author
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Tejas Patel, Olivier Costerousse, Olivier F. Bertrand, Ivo Bernat, Guido Parodi, Loic Belle, Tift Mann, Sanjit S. Jolly, and Sunil V. Rao
- Subjects
medicine.medical_specialty ,medicine.drug_class ,medicine.medical_treatment ,Myocardial Ischemia ,Postoperative Hemorrhage ,Antithrombins ,law.invention ,Postoperative Complications ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Humans ,Bivalirudin ,Myocardial infarction ,Angioplasty, Balloon, Coronary ,Heparin ,business.industry ,Anticoagulant ,Percutaneous coronary intervention ,Odds ratio ,Hirudins ,medicine.disease ,Peptide Fragments ,Recombinant Proteins ,Treatment Outcome ,Cardiovascular Diseases ,Conventional PCI ,Cardiology ,Cardiology and Cardiovascular Medicine ,business ,Mace ,medicine.drug - Abstract
With femoral access, bivalirudin decreases risks of major bleeding after percutaneous coronary intervention (PCI) and provides better net clinical benefit compared to unfractionated heparin (UFH) plus planned glycoprotein IIb/IIIa inhibitors. Whether this benefit exists compared to UFH monotherapy is less clear. We performed a systematic review and meta-analysis to compare outcomes in patients undergoing transfemoral PCI with UFH or bivalirudin. Randomized trials (n = 3) and observational studies (n = 13) comparing bivalirudin to UFH monotherapy were reviewed. Primary outcomes were 30-day rates of major adverse cardiovascular events (MACEs) including death, myocardial infarction (MI), urgent revascularization, as well as all-cause mortality, MI, major bleeding, and blood transfusion. We collected data from 16 studies involving 32,492 patients undergoing PCI. Most observational studies were performed in the United States, whereas all randomized trials were done in Europe. Compared to UFH monotherapy, bivalirudin was associated with similar risk of MACEs (odds ratios [OR] 0.92, 95% confidence interval [CI] 0.75 to 1.12), a substantial 45% relative decrease in major bleeding (OR 0.55, 95% CI 0.43 to 0.72), and a trend in the decrease of transfusion (OR 0.87, 95% CI 0.70 to 1.08). A decrease in mortality was seen in observational studies (OR 0.62, 95% CI 0.45 to 0.85) but remained inconclusive in randomized trials (OR 0.63, 95% CI 0.20 to 2.01). MI rate was similar with the 2 anticoagulants. In conclusion, in patients undergoing transfemoral PCI, the benefit of bivalirudin over UFH monotherapy is driven by a significant decrease in major bleeding with similar rates of MACE. As PCI practice moves toward other bleeding-avoidance strategies such as the radial approach, future studies should focus on the interaction between anticoagulant strategy and access-site choice.
- Published
- 2012
23. Reply
- Author
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Ivo Bernat, Tejas Patel, Olivier F. Bertrand, and Samir Pancholy
- Subjects
medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Surgery ,Transradial catheterization ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine.artery ,Occlusion ,Cardiology ,medicine ,030212 general & internal medicine ,Radial artery ,Cardiology and Cardiovascular Medicine ,business ,Ulnar artery ,Cardiac catheterization - Abstract
We greatly appreciate the letter by Dr. Koutouzis and colleagues and their interest in our study [(1)][1]. As rightly pointed out by the authors, the ULTRA (ULnar Artery Transient Compression Facilitating Radial Artery Patent Hemostasis) study [(2)][2] and PROPHET-II Trial (PROPhylactic
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- 2017
24. The radial approach in coronary and non-coronary catheterizations and interventions
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Richard Rokyta, Ivo Bernat, Jan Pešek, Jiří Koza, and Michal Šmíd
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medicine.medical_specialty ,business.industry ,Internal medicine ,Cardiology ,Medicine ,Cardiology and Cardiovascular Medicine ,business - Abstract
Výhody radialniho přistupu u koronarnich intervenci prokazaly v poslednich letech cetne studie. V tomto přehledu jsou zdůrazněny přednosti a limity transradialniho přistupu u koronarnich i nekoronarnich katetrizaci a intervenci.
- Published
- 2009
25. Impact of access site choice on outcomes of patients with cardiogenic shock undergoing percutaneous coronary intervention: A systematic review and meta-analysis
- Author
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Sasko Kedev, Enrico Romagnoli, Ghanshyam Palamaner Subash Shantha, Samir Pancholy, Sunil V. Rao, Ivo Bernat, Sanjit S. Jolly, Tejas Patel, and Olivier F. Bertrand
- Subjects
medicine.medical_specialty ,Cardiac Catheterization ,medicine.medical_treatment ,MEDLINE ,Shock, Cardiogenic ,Global Health ,law.invention ,Percutaneous Coronary Intervention ,Randomized controlled trial ,law ,Internal medicine ,Cause of Death ,medicine ,Humans ,business.industry ,Cardiogenic shock ,Percutaneous coronary intervention ,medicine.disease ,Surgery ,Survival Rate ,Meta-analysis ,Relative risk ,Conventional PCI ,Radial Artery ,Access site ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background The benefit of transradial access (TRA) in patients with cardiogenic shock (CS) is uncertain. We sought to determine the benefits of TRA in patients with CS undergoing coronary angiography/intervention. Methods MEDLINE, Embase, Cochrane Central, and electronic databases were searched for studies that assessed the following: (1) patients with CS who underwent percutaneous coronary intervention (PCI) and (2) the association between choice of arterial access, 30-day all-cause mortality, and 30-day major adverse cardiac and cerebral events (MACCEs) using random-effects model. Results From 3,652 retrieved citations, 8 studies involving 8,131 patients with CS undergoing PCI (via TRA: 2,321 patients, via TFA: 5,810 patients) were included. Transradial access was associated with significantly reduced risk for all-cause mortality (unadjusted: risk ratio [RR] 0.60, 95% CI 0.52-0.71, P I 2 = 29%, 8 included studies; adjusted: RR 0.55, 95% CI 0.46-0.65, P I 2 = 0%, 6 included studies) and MACCE (unadjusted: RR 0.68, 95% CI 0.63-0.73, P I 2 = 0%, 6 included studies; adjusted: RR 0.63, 95% CI 0.52-0.75, P I 2 = 0%, 4 included studies) at 30 days when compared with TFA. Conclusions Transradial access is associated with reduced mortality and MACCE at 30 days in patients with CS undergoing PCI. Considering the possible influence of selection bias on the effect estimate in our analysis, randomized controlled trials are needed to better assess this association.
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- 2015
26. Efficacy of Radial Versus Femoral Access in the Acute Coronary Syndrome
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Marco Valgimigli, Sasko Kedev, Sunil V. Rao, James Nolan, Samir B. Pancholy, Sanjit S. Jolly, Olivier F. Bertrand, Mamas A. Mamas, Surya Dharma, Ivo Bernat, and Douglas G. Fraser
- Subjects
medicine.medical_specialty ,Acute coronary syndrome ,business.industry ,030204 cardiovascular system & hematology ,medicine.disease ,Clinical trial ,03 medical and health sciences ,0302 clinical medicine ,Femoral access ,medicine ,In patient ,030212 general & internal medicine ,Cardiology and Cardiovascular Medicine ,Intensive care medicine ,business - Abstract
We read with great interest and concern the paper by Le May et al. [(1)][1] regarding the role of radial approach in patients with acute coronary syndrome (ACS). Our concerns are due to their inappropriate interpretation of clinical trial data and spurious arguments against radial access that runs
- Published
- 2016
27. TCT-276 Radial Artery Patency In Japanese and Non-japanese Patients After Transradial Coronary Angiography and Intervention With 6 French Slender or Standard 5 French Sheaths. A Substudy From RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT) Randomised Multicenter Trial
- Author
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Akihiko Takahashi, Yamazaki Seiji, Maarten A.H. van Leeuwen, Robert Jobe, Yves Louvard, Niels van Royen, Takashi Kajiya, Adel Aminian, Shigeru Saito, Takashi Matsukage, Sunil V. Rao, Ivo Bernat, Ferdinand Kiemeneij, and Ian C. Gilchrist
- Subjects
Coronary angiography ,medicine.medical_specialty ,business.industry ,medicine.artery ,Internal medicine ,Multicenter trial ,medicine ,Cardiology ,Radial artery ,Cardiology and Cardiovascular Medicine ,business ,Adverse effect ,Surgery - Published
- 2017
28. Radial artery occlusion
- Author
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Ivo Bernat and Olivier F. Bertrand
- Subjects
Male ,Cardiac Catheterization ,medicine.medical_specialty ,Heel ,business.industry ,Arterial Occlusive Diseases ,Hemorrhage ,General Medicine ,Surgery ,Percutaneous Coronary Intervention ,medicine.anatomical_structure ,medicine.artery ,Catheterization, Peripheral ,Radial Artery ,Occlusion ,Humans ,Medicine ,Female ,Radial artery ,Cardiology and Cardiovascular Medicine ,business - Published
- 2015
29. Early and late outcomes after primary percutaneous coronary intervention by radial or femoral approach in patients presenting in acute ST-elevation myocardial infarction and cardiogenic shock
- Author
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Jan Pešek, Ivo Bernat, Jakub Čech, Guillaume Plourde, Jimmy MacHaalany, Jiri Koza, Olivier Costerousse, Richard Rokyta, Stepan Jirous, Olivier F. Bertrand, Eltigani Abdelaal, Yoann Bataille, and Jean-Pierre Déry
- Subjects
Male ,medicine.medical_specialty ,Percutaneous ,medicine.medical_treatment ,Myocardial Infarction ,Shock, Cardiogenic ,Femoral artery ,Postoperative Hemorrhage ,Percutaneous Coronary Intervention ,medicine.artery ,Internal medicine ,medicine ,Humans ,Myocardial infarction ,Radial artery ,Aged ,business.industry ,Cardiogenic shock ,Hazard ratio ,Percutaneous coronary intervention ,Middle Aged ,medicine.disease ,Survival Analysis ,Femoral Artery ,Treatment Outcome ,Conventional PCI ,Radial Artery ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background Although radial approach is increasingly used in percutaneous coronary interventions (PCIs) including in acute myocardial infarction (MI), patients with cardiogenic shock have been excluded from comparisons with femoral approach. The aim of our study was to compare clinical outcomes in patients undergoing primary PCI with cardiogenic shock by radial and femoral approach. Methods and Results From 2,663 patients presenting with ST-elevation MI in 2 large volume radial centers, we identified 197 patients (7.4%) with signs of cardiogenic shock immediately before undergoing primary PCI. Radial approach was used in 55% of cases when at least 1 radial artery was weakly palpable, either spontaneously or after intravenous noradrenaline bolus. Patients in the radial group were older (69 ± 12 vs 64 ± 12 years, P = .010), had less diabetes (13% vs 26%, P = .028), and required less often intubation prior PCI (42% vs 66%, P = .0006) or intraaortic balloon pump (36% vs 55%, P = .0096). Mortality at 1 year was 44% in the radial group and 64% in the femoral group ( P = .0044). Independent predictors of late mortality included radial approach (hazard ratio [HR] 0.65, 95% CI 0.42-0.98, P = .041), the use of glycoprotein IIb-IIIa receptor inhibitors (HR 0.63, 95% CI 0.40-0.96, P = .032), baseline creatinine ≥110 μmol/L (HR 3.34, 95% CI 2.20-5.12, P 200 mg/dL (HR 2.02, 95% CI 1.34-3.11, P = .0008), and age >65 years (HR 1.80, 95% CI 1.18-2.79, P = .006). Conclusion Radial approach was safe and feasible in more than half of the patients with ST-elevation MI and cardiogenic shock treated by primary PCI. After adjustment for baseline and procedural characteristics, radial approach remained associated with better survival. However, prognosis of patients undergoing primary PCI in cardiogenic shock remains poor.
- Published
- 2012
30. Reply
- Author
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Richard Rokyta, Ivo Bernat, Stemi-Radial Investigators, and Olivier F. Bertrand
- Subjects
medicine.medical_specialty ,Regimen ,business.industry ,St elevation myocardial infarction ,Antithrombotic ,medicine ,cardiovascular diseases ,Cardiology and Cardiovascular Medicine ,business ,humanities ,Surgery - Abstract
We are pleased to address Dr. Lee’s comments on the results of the STEMI-RADIAL (ST Elevation Myocardial Infarction treated by RADIAL or femoral approach) trial published in the Journal [(1)][1]. First, this letter has already been published twice with almost identical content [(2,3)][2]. Second
- Published
- 2014
31. Safety of Same-Day Discharge After Percutaneous Coronary Intervention
- Author
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Eltigani Abdelaal, Samir B. Pancholy, Olivier F. Bertrand, Ronald P. Caputo, Ian C. Gilchrist, Adhir R. Shroff, Olivier Costerousse, Ivo Bernat, and Sunil V. Rao
- Subjects
medicine.medical_specialty ,business.industry ,General surgery ,medicine.medical_treatment ,medicine ,Percutaneous coronary intervention ,Evidence-based medicine ,business ,Cardiology and Cardiovascular Medicine ,Surgery ,Same day discharge - Abstract
We read with great interest the paper by Brayton et al. [(1)][1]. This paper is nearly identical to our recent publication in JACC: Cardiovascular Interventions [(2)][2]. It is interesting that 2 similar papers using the same data would be published in the JACC family of journals just a few
- Published
- 2014
- Full Text
- View/download PDF
32. Efficacy and safety of transient ulnar artery compression to recanalize acute radial artery occlusion after transradial catheterization
- Author
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Jan Pešek, Lucie Stepankova, Hana Bruhova, Ivo Bernat, Jiri Koza, Michal Šmíd, Richard Rokyta, Gabriela Sterbakova, Olivier F. Bertrand, Martin Kacer, and Olivier Costerousse
- Subjects
Male ,medicine.medical_specialty ,Duplex ultrasonography ,Coronary Angiography ,Transradial catheterization ,Ulnar Artery ,Hematoma ,medicine.artery ,Internal medicine ,Occlusion ,Catheterization, Peripheral ,medicine ,Humans ,Radial artery ,Ulnar artery ,Aged ,business.industry ,Heparin ,Incidence ,Anticoagulants ,Middle Aged ,medicine.disease ,Surgery ,Treatment Outcome ,Hemostasis ,Radial Artery ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
Radial artery occlusion (RAO) can result from transradial catheterization. We compared the incidence of RAO with 2 heparin dosage regimens after transradial coronary angiography, and we evaluated the efficacy and safety of transient homolateral ulnar artery compression to achieve acute radial artery recanalization. Patients referred for coronary angiography were randomized to very-low-dose heparin (2,000 IU) or low-dose heparin (5,000 IU). On sheath removal, hemostasis was obtained using the TR band with a plethysmography-guided patent hemostasis technique. In the case of RAO as assessed by duplex ultrasonography 3 to 4 hours after hemostasis, immediate 1-hour ulnar artery compression was applied. Hematomas >15 cm 2 were also assessed. We randomized 465 patients, 222 in the 2,000-IU group and 243 in the 5,000-IU group. The baseline and procedural characteristics were comparable in both groups. The incidence of initial RAO was 5.9% in the 2,000-IU group and 2.9% in the 5,000-IU group (p = 0.17), with a compression time of 2.10 ± 0.78 hours and 2.25 ± 0.82 hours, respectively (p = 0.051). After ulnar artery compression, the final incidence of RAO was 4.1% in the 2,000-IU group and 0.8% in the 5,000-IU group (p = 0.03). The incidence of local hematoma was 2.3% and 3.7% in the 2,000- and 5,000-IU groups, respectively (p = 0.42). In conclusion, acute RAO after transradial catheterization can be recanalized by early 1-hour homolateral ulnar artery compression. This simple nonpharmacologic method was effective and safe in patients with very-low- and low-dose heparin. Nevertheless, the incidence of final RAO remained significantly lower after a higher anticoagulation level.
- Published
- 2010
33. Percutaneous technique for creation of tricuspid regurgitation in an ovine model
- Author
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Timothy A.M. Chuter, Man Deuk Kim, Elaine E. Tseng, Barry Uchida, Hanno Hoppe, Ivo Bernat, Frederick S. Keller, Dusan Pavcnik, and Josef Rösch
- Subjects
congenital, hereditary, and neonatal diseases and abnormalities ,medicine.medical_specialty ,Percutaneous ,Cardiology ,Autopsy ,Regurgitation (circulation) ,Catheterization ,Avulsion ,Internal medicine ,Jugular vein ,Heart rate ,medicine ,Animals ,Radiology, Nuclear Medicine and imaging ,cardiovascular diseases ,Papillary muscle ,Atrioventricular valve ,Sheep ,business.industry ,Angiography ,Arrhythmias, Cardiac ,Tricuspid Valve Insufficiency ,Surgery ,Disease Models, Animal ,medicine.anatomical_structure ,cardiovascular system ,Cardiology and Cardiovascular Medicine ,business - Abstract
Experimental models of tricuspid regurgitation (TR) are needed to study the percutaneous placement of prosthetic atrioventricular valves. The purpose of this study was to develop an appropriate simple and reproducible percutaneous experimental model for creation of tricuspid regurgitation. Tricuspid regurgitation was successfully created through papillary muscle avulsion using a guide-wire loop in seven sheep with regurgitation documented on right ventricular angiograms and a significant increase in heart rate and right atrial pressures. Acute onset of tricuspid regurgitation was poorly tolerated in one animal that died. Autopsy examinations showed avulsion of one papillary muscle in four animals and two papillary muscles in three animals.
- Published
- 2007
34. 571 Meta-Analysis Comparing Bivalirudin vs Heparin-Monotherapy on Ischemic and Bleeding Outcomes After Percutaneous Coronary Intervention
- Author
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Sanjit S. Jolly, Tejas Patel, Loic Belle, Sunil V. Rao, Guido Parodi, Olivier F. Bertrand, Tift Mann, Ivo Bernat, and Olivier Costerousse
- Subjects
medicine.medical_specialty ,medicine.drug_class ,business.industry ,medicine.medical_treatment ,Anticoagulant ,Percutaneous coronary intervention ,Odds ratio ,medicine.disease ,Surgery ,law.invention ,Randomized controlled trial ,law ,Internal medicine ,Conventional PCI ,medicine ,Cardiology ,Bivalirudin ,Myocardial infarction ,Cardiology and Cardiovascular Medicine ,business ,Mace ,medicine.drug - Abstract
With femoral access, bivalirudin decreases risks of major bleeding after percutaneous coronary intervention (PCI) and provides better net clinical benefit compared to unfractionated heparin (UFH) plus planned glycoprotein IIb/IIIa inhibitors. Whether this benefit exists compared to UFH monotherapy is less clear. We performed a systematic review and meta-analysis to compare outcomes in patients undergoing transfemoral PCI with UFH or bivalirudin. Randomized trials (n 3) and observational studies (n 13) comparing bivalirudin to UFH monotherapy were reviewed. Primary outcomes were 30-day rates of major adverse cardiovascular events (MACEs) including death, myocardial infarction (MI), urgent revascularization, as well as all-cause mortality, MI, major bleeding, and blood transfusion. We collected data from 16 studies involving 32,492 patients undergoing PCI. Most observational studies were performed in the United States, whereas all randomized trials were done in Europe. Compared to UFH monotherapy, bivalirudin was associated with similar risk of MACEs (odds ratios [OR] 0.92, 95% confidence interval [CI] 0.75 to 1.12), a substantial 45% relative decrease in major bleeding (OR 0.55, 95% CI 0.43 to 0.72), and a trend in the decrease of transfusion (OR 0.87, 95% CI 0.70 to 1.08). A decrease in mortality was seen in observational studies (OR 0.62, 95% CI 0.45 to 0.85) but remained inconclusive in randomized trials (OR 0.63, 95% CI 0.20 to 2.01). MI rate was similar with the 2 anticoagulants. In conclusion, in patients undergoing transfemoral PCI, the benefit of bivalirudin over UFH monotherapy is driven by a significant decrease in major bleeding with similar rates of MACE. As PCI practice moves toward other bleeding-avoidance strategies such as the radial approach, future studies should focus on the interaction between anticoagulant strategy and access-site choice. © 2012 Elsevier Inc. All rights reserved. (Am J Cardiol 2012;110:599‐606)
- Published
- 2012
35. SAME-DAY DISCHARGE COMPARED TO OVERNIGHT HOSPITALIZATION AFTER UNCOMPLICATED PCI: A SYSTEMATIC REVIEW AND META-ANALYSIS
- Author
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Olivier Costerousse, Ronald P. Caputo, Eltigani Abdelaal, Adhir Shroff, Ivo Bernat, Olivier F. Bertrand, Sunil V. Rao, Samir Pancholy, and Ian C. Gilchrist
- Subjects
medicine.medical_specialty ,Systematic review ,business.industry ,Meta-analysis ,medicine.medical_treatment ,Conventional PCI ,Emergency medicine ,medicine ,Percutaneous coronary intervention ,Cardiology and Cardiovascular Medicine ,business ,Same day discharge - Abstract
Although there is data on the safety and feasibility of same-day discharge (SDD) after percutaneous coronary intervention (PCI), overnight hospitalization (ON) continues to be prevalent. No systematic reviews that have comprehensively examined this subject currently exist. This study aimed to
- Published
- 2013
36. 428 Same-Day Discharge Compared to Overnight Hospitalization After Uncomplicated Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis
- Author
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R. Caputo, Olivier F. Bertrand, Sunil V. Rao, Eltigani Abdelaal, Olivier Costerousse, Ian C. Gilchrist, A. Shroff, and Ivo Bernat
- Subjects
medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Meta-analysis ,Emergency medicine ,Medicine ,Percutaneous coronary intervention ,Cardiology and Cardiovascular Medicine ,business ,Same day discharge ,Surgery - Published
- 2012
37. Koronární ektazie u pacientky s hypertrofickou kardiomyopatií
- Author
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Roman Ondrejčák, Michal Paďour, Beranika Podzemská, Markéta Novotná, Jaroslav Žák, Ivo Bernat, and Marcela Škvařilová
- Subjects
business.industry ,Medicine ,Cardiology and Cardiovascular Medicine ,business
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