Browsing by Author "Sinha, Anjan K."

Now showing 1 - 4 of 4
  • Thumbnail Image
    Item
    Femoral Artery Closure Devices vs Manual Compression During Cardiac Catheterization and Percutaneous Coronary Intervention
    (Elsevier, 2022-06-29) Kreutz, Rolf P.; Phookan, Sujoy; Bahrami, Hamid; Sinha, Anjan K.; Breall, Jeffrey A.; Revtyak, George E.; Ephrem, Georges; Zenisek, Joseph R.; Frick, Kyle A.; Jaradat, Ziad A.; Abu Romeh, Ibrahim S.; O’Leary, Brian A.; Ansari, Hamza Z.; Ferguson, Andrew D.; Zawacki, Kevin E.; Hoque, Mohammad Z.; Iqtidar, Ali F.; Lambert, Nathan D.; von der Lohe, Elisabeth; Medicine, School of Medicine
    Background: Femoral arterial access remains widely used despite recent increase in radial access for cardiac catheterization and percutaneous coronary intervention (PCI). Various femoral artery closure devices have been developed and are commonly used to shorten vascular closure times, with variable rates of vascular complications observed in clinical trials. We sought to examine the rates of contemporary outcomes during diagnostic catheterization and PCI with the most common femoral artery closure devices. Methods: We identified patients who had undergone either diagnostic catheterization alone (n = 14,401) or PCI (n = 11,712) through femoral artery access in the Indiana University Health Multicenter Cardiac Cath registry. We compared outcomes according to closure type: manual compression, Angio-Seal, Perclose, or Mynx. Access complications and bleeding outcomes were measured according to National Cardiovascular Data ​Registry standard definitions. Results: The use of any vascular closure device as compared to manual femoral arterial access hold was associated with a significant reduction in vascular access complications and bleeding events in patients who underwent PCI. No significant difference in access-site complications was observed for diagnostic catheterization alone. Among closure devices, Perclose and Angio-Seal had a lower rate of hematoma than Mynx. Conclusions: The use of femoral artery access closure devices is associated with a reduction in vascular access complication rates as compared to manual femoral artery compression in patients who undergo PCI.
  • Thumbnail Image
    Item
    Impact of Sex on Outcomes With Femoral Artery Closure Devices Versus Manual Compression in Patients Undergoing Percutaneous Coronary Intervention
    (Wiley, 2024-12-19) Anderson, Wesley L.; Torabi, Asad J.; O'leary, Brian A.; Breall, Jeffrey A.; Sinha, Anjan K.; Jaradat, Ziad A.; Morris, Michelle C.; Frick, Kyle A.; Romeh, Ibrahim A.; Iqtidar, Ali F.; von der Lohe, Elisabeth; Kreutz, Rolf P.; Medicine, School of Medicine
    Background and aims: Femoral artery access is widely used despite recent increase in radial access for percutaneous coronary interventions (PCI). Femoral artery closure devices are used to shorten vascular closure time and reduce bleeding. We sought to examine sex-based outcomes of femoral artery vascular closure devices (VCD) in patients undergoing PCI. Methods: We identified patients who had undergone PCI (n = 11,415) in the Indiana University Health Multicenter Cardiac Cath registry using femoral artery access. Clinical outcomes were compared between VCD and manual compression and analyzed according to sex. Patients with cardiogenic shock and left ventricular support devices were excluded. Results: The use of any vascular closure device as compared to femoral artery manual compression was associated with a reduction in 72-h bleeding events (adjusted odds ratio [OR]: 0.64; 95% confidence interval [CI]: 0.46-0.87). With manual compression, women had higher rates of 72-h bleeding as compared to men (4.5% vs. 1.6%, p < 0.001). Women demonstrated greater absolute risk reduction in 72-h bleeding events with use of VCD as compared to men (2.8% vs. 0.8%, p < 0.001). For women, VCD were associated with lower risk of access site bleeding (OR: 0.43; 95% CI: 0.24-0.8), hematoma (OR: 0.36; 95% CI: 0.2-0.63), and vascular complications (OR: 0.25, 95% CI: 0.09-0.72). Use of VCD was associated with lower risk of in-hospital death (adjusted OR: 0.4; 95% CI: 0.28-0.58; p < 0.001) in multivariable regression analysis. Conclusion: Women derive more benefit from use of femoral artery VCD during PCI than men with greater reduction in bleeding rates, access site hematoma, and vascular complications.
  • Thumbnail Image
    Item
    Outcomes in patients with aortic stenosis and severely reduced ejection fraction following surgical aortic valve replacement and transcatheter aortic valve replacement
    (Springer Nature, 2024-04-20) Bain, Eric R.; George, Bistees; Jafri, Syed H.; Rao, Roopa A.; Sinha, Anjan K.; Guglin, Maya E.; Medicine, School of Medicine
    Background: Patients with severe aortic stenosis (AS) and left ventricular (LV) dysfunction demonstrate improvement in left ventricular injection fraction (LVEF) after aortic valve replacement (AVR). The timing and magnitude of recovery in patients with very low LVEF (≤ 25%) in surgical or transcatheter AVR is not well studied. Objective: Determine clinical outcomes following transcatheter aortic valve replacement (TAVR) and surgical aortic valve repair (SAVR) in the subset of patients with severely reduced EF ≤ 25%. Methods: Single-center, retrospective study with primary endpoint of LVEF 1-week following either procedure. Secondary outcomes included 30-day mortality and delayed postprocedural LVEF. T-test was used to compare variables and linear regression was used to adjust differences among baseline variables. Results: 83 patients were enrolled (TAVR = 56 and SAVR = 27). TAVR patients were older at the time of procedure (TAVR 77.29 ± 8.69 vs. SAVR 65.41 ± 10.05, p < 0.001). One week post procedure, all patients had improved LVEF after both procedures (p < 0.001). There was no significant difference in LVEF between either group (TAVR 33.5 ± 11.77 vs. SAVR 35.3 ± 13.57, p = 0.60). Average LVEF continued to rise and increased by 101% at final follow-up (41.26 ± 13.70). 30-day mortality rates in SAVR and TAVR were similar (7.4% vs. 7.1%, p = 0.91). Conclusion: Patients with severe AS and LVEF ≤ 25% have a significant recovery in post-procedural EF following AVR regardless of method. LVEF doubled at two years post-procedure. There was no significant difference in 30-day mortality or mean EF recovery between TAVR and SAVR.
  • Thumbnail Image
    Item
    Two-in-one aortic valve sizing and valvuloplasty conductance balloon catheter
    (Wiley Blackwell (John Wiley & Sons), 2015-07) Svendsen, Mark C.; Sinha, Anjan K.; Berwick, Zachary C.; Combs, William; Teague, Shawn D.; Lefevre, Thierry; Babaliaros, Vasilis; Kassab, Ghassan; Department of Engineering Technology, School of Engineering and Technology
    BACKGROUND: Inaccurate aortic valve sizing and selection is linked to paravalvular leakage in transcatheter aortic valve replacement (TAVR). Here, a novel sizing valvuloplasty conductance balloon (SVCB) catheter is shown to be accurate, reproducible, unbiased, and provides real-time tool for aortic valve sizing that fits within the standard valvuloplasty procedure. METHODS AND RESULTS: The SVCB catheter is a valvuloplasty device that uses real-time electrical conductance measurements based on Ohm's Law to size the balloon opposed against the aortic valve at any given inflation pressure. Accuracy and repeatability of the SVCB catheter was performed on the bench in phantoms of known dimension and ex vivo in three domestic swine aortic annuli with comparison to computed tomography (CT) and dilator measurements. Procedural workflow and safety was demonstrated in vivo in three additional domestic swine. SVCB catheter measurements had negligible bias or error for bench accuracy considered as the gold standard (Bias: -0.11 ± 0.26 mm; Error: 1.2%), but greater disagreement in ex vivo versus dilators (Bias: -0.3 ± 1.1 mm; Error: 4.5%), and ex vivo versus CT (Bias: -1.0 ± 1.6 mm; Error: 8.7%). The dilator versus CT accuracy showed similar agreement (Bias: -0.9 ± 1.5 mm; Error: 7.3%). Repeatability was excellent on the bench (Bias: 0.02 ± 0.12 mm; Error: 0.5%) and ex vivo (Bias: -0.4 ± 0.9 mm; Error: 4.6%). In animal studies, the device fit well within the procedural workflow with no adverse events or complications. CONCLUSIONS: Due to the clinical relevance of this accurate, repeatable, unbiased, and real-time sizing measurement, the SVCB catheter may provide a useful tool prior to TAVR. These findings merit a future human study.