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Martin B Leon - One of the best experts on this subject based on the ideXlab platform.

  • vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices
    Journal of the American College of Cardiology, 2001
    Co-Authors: George Dangas, Spyros Kokolis, Dmitriy N Feldman, Lowell F Satler, Augusto D Pichard, Kenneth M Kent, Roxana Mehran, Alexandra J Lansky, Gregg W Stone, Martin B Leon
    Abstract:

    Abstract OBJECTIVES We evaluated the vascular complications after hemostasis with arteriotomy closure devices (ACD) versus manual compression after percutaneous coronary interventions (PCI). BACKGROUND Previous clinical studies have indicated that ACD can be used for achievement of hemostasis and early ambulation after PCI. This study investigated the safety of ACD in achieving hemostasis after PCI compared with manual compression in a large cohort of consecutive patients. METHODS A total of 5,093 patients were followed after PCI was performed with the transfemoral approach. Univariate and multivariate analysis were used to identify the predictors of vascular complications with ACD (n = 516) or with manual compression (n = 5,892) as a hemostasis option after Sheath Removal. RESULTS The use of ACD was associated with a more frequent occurrence of hematoma compared with manual compression (9.3 vs. 5.1%, p 15%) with ACD versus manual compression (5.2% vs. 2.5%, p CONCLUSIONS In this early experience with ACD after PCI, their use was associated with higher vascular complication rates than hemostasis with manual compression.

  • vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices
    Journal of the American College of Cardiology, 2001
    Co-Authors: George Dangas, Spyros Kokolis, Dmitriy N Feldman, Lowell F Satler, Augusto D Pichard, Kenneth M Kent, Roxana Mehran, Alexandra J Lansky, Gregg W Stone, Martin B Leon
    Abstract:

    OBJECTIVES We evaluated the vascular complications after hemostasis with arteriotomy closure devices (ACD) versus manual compression after percutaneous coronary interventions (PCI). BACKGROUND Previous clinical studies have indicated that ACD can be used for achievement of hemostasis and early ambulation after PCI. This study investigated the safety of ACD in achieving hemostasis after PCI compared with manual compression in a large cohort of consecutive patients. METHODS A total of 5,093 patients were followed after PCI was performed with the transfemoral approach. Univariate and multivariate analysis were used to identify the predictors of vascular complications with ACD (n = 516) or with manual compression (n = 5,892) as a hemostasis option after Sheath Removal. RESULTS The use of ACD was associated with a more frequent occurrence of hematoma compared with manual compression (9.3 vs. 5.1%, p 15%) with ACD versus manual compression (5.2% vs. 2.5%, p < 0.001). Similar rates of pseudoaneurysm and arteriovenous fistulae were noted with either hemostasis technique. Vascular surgical repair at the access site was required more often with ACD versus manual compression (2.5 vs. 1.5%, p = 0.03). CONCLUSIONS In this early experience with ACD after PCI, their use was associated with higher vascular complication rates than hemostasis with manual compression.

  • rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty results of a randomized trial of a novel hemostatic device
    Journal of the American College of Cardiology, 1995
    Co-Authors: William G Kussmaul, Kenneth M Kent, Martin B Leon, Maurice Buchbinder, Patrick L Whitlow, Umit T Aker, Richard R Heuser, Spencer B King, Daniel M Kolansky, Joseph G Sandza
    Abstract:

    Abstract Objectives. This study was performed to test the safety and efficacy of a novel bioabsorbable hemostatic puncture closure device deployed through an arterial Sheath. Background. Cardiac catheterization procedures are associated with a risk of complications at the arterial access site. Increasing numbers of interventional procedures requiring large Sheaths or intense anticoagulation underline the need for occure, rapid methods of obtaining hemostasis at the time of Sheath Removal. Methods. We conducted a randomized, multicenter trial in 435 patients undergoing cardiac catheterization or angioplasty at eight participating centers. In 218 patients, hemostasis was achieved using the device (group 1); 217 patients were assigned to the manual pressure control group (group II). Results. There were no significant differences in baseline characteristics. Time to hemostasis was considerably shorter in group I (2.5 ± 15.2 vs 15.3 ± 11.7 min [mean ± SD], p Conclusions. This Sheath-deployed, bioabsorbable device provides a safe and effective means of obtaining rapid arterial hemostasis after cardiac catheterization procedures. It appears to be particularly useful in those patients most at risk for access site complications.

F W Amann - One of the best experts on this subject based on the ideXlab platform.

  • comparison of costs and safety of a suture mediated closure device with conventional manual compression after coronary artery interventions
    Catheterization and Cardiovascular Interventions, 2002
    Co-Authors: Hans Rickli, Martin Unterweger, Gabor Sutsch, Hanspeter Brunnerla Rocca, Markus Sagmeister, Peter Ammann, F W Amann
    Abstract:

    The aim of this study was to assess costs and safety of immediate femoral Sheath Removal and closure with a suture-mediated closure device (Perclose, Menlo Park, CA) in patients undergoing elective (PCI). A total of 193 patients was prospectively randomized to immediate arterial Sheath Removal and access site closure with a suture-mediated closure device (SMC; n = 96) or Sheath Removal 4 hr after PCI followed by manual compression (MC; n = 97). In the SMC group, patients were ambulated 4 hr after elective PCI if hemostasis was achieved. In the MC group, patients were ambulated the day after the procedure. In addition to safety, total direct costs including physician and nursing time, infrastructure, and the device were assessed in both groups. Total direct costs were significantly (all P < 0.001) lower in the SMC group. Successful hemostasis without major complication was achieved in all patients. The time to achieve hemostasis was significantly shorter in the SMC group (7.1 +/- 3.4 vs. 22.9 +/- 14.0 min; P < 0.01) and 85% of SMC patients were ambulated on the day of intervention. Suture-mediated closure allows a reduction in hospitalization time, leading to significant cost savings due to decreased personnel and infrastructural demands. In addition, the use of SMC is safe and convenient to the patients.

  • comparison of costs and safety of a suture mediated closure device with conventional manual compression after coronary artery interventions
    Catheterization and Cardiovascular Interventions, 2002
    Co-Authors: Hans Rickli, Martin Unterweger, Gabor Sutsch, Hanspeter Brunnerla Rocca, Markus Sagmeister, Peter Ammann, F W Amann
    Abstract:

    The aim of this study was to assess costs and safety of immediate femoral Sheath Removal and closure with a suture-mediated closure device (Perclose, Menlo Park, CA) in patients undergoing elective (PCI). A total of 193 patients was prospectively randomized to immediate arterial Sheath Removal and access site closure with a suture-mediated closure device (SMC; n 96) or Sheath Removal 4 hr after PCI followed by manual compression (MC; n 97). In the SMC group, patients were ambulated 4 hr after elective PCI if hemostasis was achieved. In the MC group, patients were ambulated the day after the procedure. In addition to safety, total direct costs including physician and nursing time, infrastructure, and the device were assessed in both groups. Total direct costs were significantly (all P < 0.001) lower in the SMC group. Successful hemostasis without major complication was achieved in all patients. The time to achieve hemostasis was significantly shorter in the SMC group (7.1 3.4 vs. 22.9 14.0 min; P < 0.01) and 85% of SMC patients were ambulated on the day of intervention. Suture-mediated closure allows a reduction in hospitalization time, leading to significant cost savings due to decreased personnel and infrastructural demands. In addition, the use of SMC is safe and convenient to the patients. Cathet Cardiovasc Intervent 2002;57:297–302. © 2002 Wiley-Liss, Inc.

  • early Sheath Removal after coronary artery interventions with use of a suture mediated closure device clinical outcome and results of doppler us evaluation
    Journal of Vascular and Interventional Radiology, 2000
    Co-Authors: Denis R Wetter, Hans Rickli, Alexander Von Smekal, F W Amann
    Abstract:

    PURPOSE To evaluate the safety and efficacy of a suture-mediated closure device by comparing clinical outcomes of its use to those of manual compression and by using Doppler ultrasound (US) examination. MATERIALS AND METHODS One hundred patients were randomized to treatment with either suture-mediated closure ( n = 50) or manual compression ( n = 50) after percutaneous transluminal coronary angioplasty (PTCA). The 50 patients randomized to receive suture-based treatment were allowed to get out of bed 4 hours after the procedure, whereas bed rest was required for 1 day in the patients treated with manual compression. All patients underwent clinical and US examination before getting out of bed and before discharge from the hospital. RESULTS Forty-seven of 50 patients randomized to undergo suture-mediated closure were ambulatory the day of intervention, in 6.2 hours ± 4.7 (mean ± SE) after undergoing PTCA. The results of the US examination for these patients demonstrated the absence of bleeding complications after getting out of bed. All patients treated with use of manual compression were ambulatory the following day, 18.3 hours ± 2.2 after undergoing PTCA. There was no difference in the occurrence of vascular complications between the two groups. CONCLUSION Suture-based closure is a safe and effective method of achieving immediate hemostasis and shorter bed rest without increasing the risk of bleeding complications in PTCA procedures.

Roxana Mehran - One of the best experts on this subject based on the ideXlab platform.

  • radial artery occlusion preventing insult to injury
    Catheterization and Cardiovascular Interventions, 2015
    Co-Authors: Jaya Chandrasekhar, Roxana Mehran
    Abstract:

    Key Points Intra-arterial nitroglycerin prior to transradial Sheath Removal may reduce the incidence of radial artery occlusion (RAO). Operators must observe careful attention to all aspects of transradial catheterization, particularly patent hemostasis; as well as independently monitor the institutional incidence of RAO to prompt improvements in practice. Future studies on the impact of pre-puncture ultrasound, novel Sheaths, hemostatic devices, and potent oral and intravenous antithrombotic therapy on 30-day RAO diagnosed by ultrasound may allow further reduction of RAO in a real-world practice.

  • a phase 2 randomized partially blinded active controlled study assessing the efficacy and safety of variable anticoagulation reversal using the reg1 system in patients with acute coronary syndromes results of the radar trial
    European Heart Journal, 2013
    Co-Authors: Thomas J Povsic, Roxana Mehran, John P Vavalle, Laura H Aberle, Jaroslaw D Kasprzak, Mauricio G Cohen, Christoph Bode, Christopher E Buller, Gilles Montalescot, Jan H Cornel
    Abstract:

    Aims We sought to determine the degree of anticoagulation reversal required to mitigate bleeding, and assess the feasibility of using pegnivacogin to prevent ischaemic events in acute coronary syndrome (ACS) patients managed with an early invasive approach. REG1 consists of pegnivacogin, an RNA aptamer selective factor IXa inhibitor, and its complementary controlling agent, anivamersen. REG1 has not been studied in invasively managed patients with ACS nor has an optimal level of reversal allowing safe Sheath Removal been defined. Methods and results Non-ST-elevation ACS patients ( n = 640) with planned early cardiac catheterization via femoral access were randomized 2:1:1:2:2 to pegnivacogin with 25, 50, 75, or 100% anivamersen reversal or heparin. The primary endpoint was total ACUITY bleeding through 30 days. Secondary endpoints included major bleeding and the composite of death, myocardial infarction, urgent target vessel revascularization, or recurrent ischaemia. Enrolment in the 25% reversal arm was suspended after 41 patients. Enrolment was stopped after three patients experienced allergic-like reactions. Bleeding occurred in 65, 34, 35, 30, and 31% of REG1 patients with 25, 50, 75, and 100% reversal and heparin. Major bleeding occurred in 20, 11, 8, 7, and 10% of patients. Ischaemic events occurred in 3.0 and 5.7% of REG1 and heparin patients, respectively. Conclusion At least 50% reversal is required to allow safe Sheath Removal after cardiac catheterization. REG1 appears a safe strategy to anticoagulate ACS patients managed invasively and warrants further investigation in adequately powered clinical trials of patients who require short-term high-intensity anticoagulation. Clinical Trials Registration: ClinicalTrials.gov [NCT00932100][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00932100&atom=%2Fehj%2Fearly%2F2012%2F08%2F01%2Feurheartj.ehs232.atom

  • vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices
    Journal of the American College of Cardiology, 2001
    Co-Authors: George Dangas, Spyros Kokolis, Dmitriy N Feldman, Lowell F Satler, Augusto D Pichard, Kenneth M Kent, Roxana Mehran, Alexandra J Lansky, Gregg W Stone, Martin B Leon
    Abstract:

    Abstract OBJECTIVES We evaluated the vascular complications after hemostasis with arteriotomy closure devices (ACD) versus manual compression after percutaneous coronary interventions (PCI). BACKGROUND Previous clinical studies have indicated that ACD can be used for achievement of hemostasis and early ambulation after PCI. This study investigated the safety of ACD in achieving hemostasis after PCI compared with manual compression in a large cohort of consecutive patients. METHODS A total of 5,093 patients were followed after PCI was performed with the transfemoral approach. Univariate and multivariate analysis were used to identify the predictors of vascular complications with ACD (n = 516) or with manual compression (n = 5,892) as a hemostasis option after Sheath Removal. RESULTS The use of ACD was associated with a more frequent occurrence of hematoma compared with manual compression (9.3 vs. 5.1%, p 15%) with ACD versus manual compression (5.2% vs. 2.5%, p CONCLUSIONS In this early experience with ACD after PCI, their use was associated with higher vascular complication rates than hemostasis with manual compression.

  • vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices
    Journal of the American College of Cardiology, 2001
    Co-Authors: George Dangas, Spyros Kokolis, Dmitriy N Feldman, Lowell F Satler, Augusto D Pichard, Kenneth M Kent, Roxana Mehran, Alexandra J Lansky, Gregg W Stone, Martin B Leon
    Abstract:

    OBJECTIVES We evaluated the vascular complications after hemostasis with arteriotomy closure devices (ACD) versus manual compression after percutaneous coronary interventions (PCI). BACKGROUND Previous clinical studies have indicated that ACD can be used for achievement of hemostasis and early ambulation after PCI. This study investigated the safety of ACD in achieving hemostasis after PCI compared with manual compression in a large cohort of consecutive patients. METHODS A total of 5,093 patients were followed after PCI was performed with the transfemoral approach. Univariate and multivariate analysis were used to identify the predictors of vascular complications with ACD (n = 516) or with manual compression (n = 5,892) as a hemostasis option after Sheath Removal. RESULTS The use of ACD was associated with a more frequent occurrence of hematoma compared with manual compression (9.3 vs. 5.1%, p 15%) with ACD versus manual compression (5.2% vs. 2.5%, p < 0.001). Similar rates of pseudoaneurysm and arteriovenous fistulae were noted with either hemostasis technique. Vascular surgical repair at the access site was required more often with ACD versus manual compression (2.5 vs. 1.5%, p = 0.03). CONCLUSIONS In this early experience with ACD after PCI, their use was associated with higher vascular complication rates than hemostasis with manual compression.

Olivier F Bertrand - One of the best experts on this subject based on the ideXlab platform.

  • 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
    Journal of Interventional Cardiology, 2020
    Co-Authors: Dmitrii V. Ognerubov, Ivo Bernat, Olivier F Bertrand, Alexander Sedaghat, Sergey I. Provatorov, Andrey S. Tereshchenko, Goar K. Arutyunyan, Olga A. Pogorelova, Maria I. Tripoten, Tatyana V Balakhonova.
    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 ( ). 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 ( ). 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.

  • 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
    'Hindawi Limited', 2020
    Co-Authors: Dmitrii V. Ognerubov, Ivo Bernat, Olivier F Bertrand, Alexander Sedaghat, Sergey I. Provatorov, Andrey S. Tereshchenko, Goar K. Arutyunyan, Olga A. Pogorelova, Maria I. Tripoten, Tatyana V Balakhonova.
    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 50%, but only in the short hemostasis group

  • frequency of radial artery occlusion after transradial access in patients receiving warfarin therapy and undergoing coronary angiography
    American Journal of Cardiology, 2014
    Co-Authors: Samir Pancholy, Olivier F Bertrand, Imdad Ahmed, Tejas Patel
    Abstract:

    The efficacy of warfarin-induced anticoagulation in reducing radial artery occlusion (RAO) after transradial access is not known. The present case-control study compared the incidence of early (24 hours) and late (30 days) RAO in patients undergoing transradial diagnostic coronary angiography during therapeutic warfarin anticoagulation (group 1) with that of a matched (3:1) cohort of patients not receiving warfarin and receiving intraprocedural heparin (group 2). All patients underwent transradial diagnostic coronary angiography using a 5F hydrophilic introducer Sheath. The patients in group 2 received an intravenous heparin bolus (50 IU/kg) immediately after Sheath insertion. After Sheath Removal, hemostasis was obtained using the TR-band (Terumo Interventional Systems, Terumo Medical, Tokyo, Japan) and a plethysmography-guided patent hemostasis technique. We included 86 patients receiving warfarin with an international normalized ratio of 2 to 4 in group 1 and 250 matched patients in group 2. No significant differences were present in the demographic and procedural variables between the 2 groups. Early RAO occurred in 18.6% of the patients in group 1 compared with 9.6% of patients in group 2 (p = 0.024). The incidence of late RAO remained significantly higher in group 1 compared with group 2 (13.9% vs 5.2%, p = 0.01). All patients with RAO remained asymptomatic. In conclusion, patients receiving chronic oral anticoagulation with warfarin and undergoing transradial coronary angiography without parenteral anticoagulation had a higher incidence of early and late RAO compared with patients receiving standard intravenous heparin therapy.

  • comparison of a priori versus provisional heparin therapy on radial artery occlusion after transradial coronary angiography and patent hemostasis from the pharaoh study
    American Journal of Cardiology, 2012
    Co-Authors: Samir Pancholy, Olivier F Bertrand, Tejas Patel
    Abstract:

    Systemic anticoagulation decreases the risk of radial artery occlusion (RAO) after transradial catheterization and standard occlusive hemostasis. We compared the efficacy and safety of provisional heparin use only when the technique of patent hemostasis was not achievable to standard a priori heparin administration after radial Sheath introduction. Patients referred for coronary angiography were randomized in 2 groups. In the a priori group, 200 patients received intravenous heparin (50 IU/kg) immediately after Sheath insertion. In the provisional group, 200 patients did not receive heparin during the procedure. After Sheath Removal, hemostasis was obtained using a TR band (Terumo corporation, Tokyo, Japan) with a plethysmography-guided patent hemostasis technique. In the provisional group, no heparin was given if radial artery patency could be obtained and maintained. If radial patency was not achieved, a bolus of heparin (50 IU/kg) was given. Radial artery patency was evaluated at 24 hours (early RAO) and 30 days after the procedure (late RAO) by plethysmography. Patent hemostasis was obtained in 67% in the a priori group and 74% in the provisional group (p = 0.10). Incidence of RAO remained similar in the 2 groups at the early (7.5% vs 7.0%, p = 0.84) and late (4.5% vs 5.0%, p = 0.83) evaluations. Women, patients with diabetes, patients having not received heparin, and patients without radial artery patency during hemostasis had more RAO. By multivariate analysis, patent radial artery during hemostasis (odds ratio [OR] 0.03, 95% confidence interval [CI] 0.004 to 0.28, p = 0.002) and diabetes (OR 11, 95% CI 3 to 38,p

  • comparison of a priori versus provisional heparin therapy on radial artery occlusion after transradial coronary angiography and patent hemostasis from the pharaoh study
    American Journal of Cardiology, 2012
    Co-Authors: Samir Pancholy, Olivier F Bertrand, Tejas Patel
    Abstract:

    Systemic anticoagulation decreases the risk of radial artery occlusion (RAO) after transradial catheterization and standard occlusive hemostasis. We compared the efficacy and safety of provisional heparin use only when the technique of patent hemostasis was not achievable to standard a priori heparin administration after radial Sheath introduction. Patients referred for coronary angiography were randomized in 2 groups. In the a priori group, 200 patients received intravenous heparin (50 IU/kg) immediately after Sheath insertion. In the provisional group, 200 patients did not receive heparin during the procedure. After Sheath Removal, hemostasis was obtained using a TR band (Terumo corporation, Tokyo, Japan) with a plethysmography-guided patent hemostasis technique. In the provisional group, no heparin was given if radial artery patency could be obtained and maintained. If radial patency was not achieved, a bolus of heparin (50 IU/kg) was given. Radial artery patency was evaluated at 24 hours (early RAO) and 30 days after the procedure (late RAO) by plethysmography. Patent hemostasis was obtained in 67% in the a priori group and 74% in the provisional group (p = 0.10). Incidence of RAO remained similar in the 2 groups at the early (7.5% vs 7.0%, p = 0.84) and late (4.5% vs 5.0%, p = 0.83) evaluations. Women, patients with diabetes, patients having not received heparin, and patients without radial artery patency during hemostasis had more RAO. By multivariate analysis, patent radial artery during hemostasis (odds ratio [OR] 0.03, 95% confidence interval [CI] 0.004 to 0.28, p = 0.002) and diabetes (OR 11, 95% CI 3 to 38,p <0.0001) were independent predictors of late RAO, whereas heparin was not (OR 0.45 95% CI 0.13 to 1.54, p = 0.20). In conclusion, our results suggest that maintenance of radial artery patency during hemostasis is the most important parameter to decrease the risk of RAO. In selected cases, provisional use of heparin appears feasible and safe when patent hemostasis is maintained.

William W Oneill - One of the best experts on this subject based on the ideXlab platform.

  • optimal tr band weaning strategy while minimizing vascular access site complications
    Cardiovascular Revascularization Medicine, 2019
    Co-Authors: Sunay Shah, Ryan Gindi, Akshay Khandelwal, Mohammad Alqarqaz, Mohammad Zaidan, Michele Voeltz, Gerald C Koenig, Mir B Basir, Henry E Kim, William W Oneill
    Abstract:

    Abstract Introduction The purpose of the study is to develop an optimal TR-Band weaning strategy while minimizing vascular access site complications of hematoma or radial artery occlusion (RAO). Methods The trial was a randomized, prospective, single center study of 129 patients who underwent cardiac catheterization via the radial artery. Group A was an accelerated protocol in which weaning was initiated 20 min after Sheath Removal. Group B was an adjusted protocol, in which weaning was dependent on the amount of anti-platelet or anti-coagulation used. All patients underwent radial artery ultrasound to demonstrate arterial patency. Results Baseline characteristics were similar in both groups, and PCI was performed in 36.7% of patients in Group A and 37.7% of patients in Group B. RAO occurred in 7.7% of patients overall, with no statistical difference between groups (Group A 5% versus Group B 10.1%, p-value = 0.337). Hematoma formation >5 cm in diameter occurred in 4.6% of patients in the overall cohort, without statistical difference between groups (Group A 5% versus Group B 4.3%, p-value = 1). The TR-Band duration was significantly shorter in Group A compared to Group B (112.9 ± 50.7 versus 130.7 ± 51.1 in minutes, respectively, p-value = 0.013). Conclusion We have demonstrated an accelerated weaning protocol is simple to utilize for nursing staff without increased vascular site complications of RAO or hematoma formation.

  • optimal tr band weaning strategy while minimizing vascular access site complications
    Journal of the American College of Cardiology, 2018
    Co-Authors: Ryan Gindi, William W Oneill, Sunay Shah, Akshay Khandelwal, Mohammad Alqarqaz, Mohammad Zaidan, Michele Voeltz, Gerald C Koenig, Henry Kim, Khaldoon Alaswad
    Abstract:

    Transradial cardiac catheterization is increasing in the United States due to the advantages of less access site complications and patient preference. A compression device is most commonly used to achieve hemostasis following Sheath Removal, however the optimal weaning strategy to expedite TR-band

  • suprasternal direct aortic approach transcatheter aortic valve replacement avoids sternotomy and thoracotomy first in man experience
    European Journal of Cardio-Thoracic Surgery, 2015
    Co-Authors: Andy C Kiser, William W Oneill, Eduardo De Marchena, Richard Stack, Mauricio Zarate, Antonio E Dager, Michael J Reardon
    Abstract:

    OBJECTIVES: Direct aortic deployment of a transcatheter aortic valve eliminates the need to traverse the aortic arch with the valve delivery system, enables placement of large Sheaths in the aorta and innominate artery, provides maximal precision during deployment and ensures a safe, conventional surgical aortotomy closure. We describe the initial experience with the Suprasternal Aortic Access System (SuprAA System, Aegis Surgical Ltd, Dublin, Ireland) for direct transaortic/innominate valve delivery. METHODS: Patients with severe, symptomatic aortic stenosis who were candidates for transcatheter aortic valve replacement (TAVR) via a direct transaortic approach were enrolled in the SuprAA-TAVR First-in-Man Study. Under general anaesthesia, the innominate artery and aortic arch were exposed in each patient, using the SuprAA System via a 2.5-cm incision directly above the sternal notch. The TAVR delivery Sheath was positioned and the transcatheter valve deployed routinely under fluoroscopic guidance. Upon Sheath Removal, haemostasis at the aortotomy site was confidently secured using a double purse-string suture closure. All were extubated immediately. A meta-analysis of the direct aortic approach was done for comparison. RESULTS: Four male patients (mean 82.5 years) underwent SuprAA-TAVR (2 CoreValve; 2 SAPIEN). Anatomical visualization was excellent and suprasternal valve deployment was accurate regardless of Sheath size with 100% Valve Academic Research Consortium-2 procedural success. The average total procedure time was 109.5 min without perioperative wound or vascular complications. CONCLUSIONS: The SuprAA System provides direct aortic/innominate access without sternal or thoracotomy incision. Patient recovery to normal activity is maximized, Sheath size limitations are eliminated and valve deployment is precise. This innovative system creates a new and exciting minimally invasive approach for high-risk patients with aortic stenosis.

  • heparin after percutaneous intervention hapi a prospective multicenter randomized trial of three heparin regimens after successful coronary intervention
    Journal of the American College of Cardiology, 1999
    Co-Authors: Maher Rabah, William W Oneill, Denise Mason, David W M Muller, Randal Hundley, Aaron D Kugelmass, Bonnie H Weiner, Louis Cannon, Robert D Safian
    Abstract:

    OBJECTIVES The purpose of this study was to determine the incidence of bleeding, vascular, and ischemic complications using three different heparin regimens after successful intervention. BACKGROUND The ideal dose and duration of heparin infusion after successful coronary intervention is unknown. METHODS Patients were randomized to one of three heparin strategies after coronary intervention: Group 1 (n = 157 patients) received prolonged (12 to 24 h) heparin infusion followed by Sheath Removal; Group 2 (n = 120 patients) underwent early Removal of Sheaths, followed by reinstitution of heparin infusion for 12 to 18 h; Group 3 (n = 137 patients) did not receive any further heparin after intervention with early Sheath Removal. The primary end point of the study was the combined incidence of in-hospital bleeding and vascular events. Secondary end points included in-hospital ischemic events, length of stay, cost and one-month outcome. RESULTS After successful coronary intervention, 414 patients were randomized. Unstable angina or postinfarction angina was present in 83% of patients before intervention. The combined incidence of bleeding and vascular events was 21% in Group 1, 14% in Group 2 and 8% in Group 3 (p = 0.01). The overall incidence of in-hospital ischemic complications was 2.2%; there were no differences between groups. Length of hospital stay was shorter (p = 0.033) and adjusted hospital cost was lower (p < 0.001) for Group 3. At 30 days, the incidence of delayed cardiac and vascular events was similar for all three groups. CONCLUSIONS Heparin infusion after successful coronary intervention is associated with more minor bleeding and vascular injury, prolonged length of stay and increased cost. In-hospital and one-month ischemic events rarely occur after successful intervention, irrespective of heparin use. Routine postprocedure heparin is not recommended, even in patients who present with unstable ischemic syndromes.