“Mind the Gap.”
— London subway announcement
In this issue of the Journal of Invasive Cardiology, Hermiller and colleagues present the results of their “Pivotal Trial of a Novel Extravascular Collagen-Based Closure Device Compared to Manual Compression in Diagnostic and Interventional Patients: The Vascade VCS RESPECT trial.1 Previous studies2-6 established a significant clinical role for suture-based as well as collagen-plug based vascular closure devices (VCDs) in reducing time to hemostasis and ambulation, thereby facilitating early discharge of patients after either diagnostic and/or catheter-based interventions. However, building on these achievements, the RESPECT trial1 patients treated with the newer Vascade vascular closure system also experienced significantly fewer adverse and minor bleeding events. This is unique within the arena of prior VCD studies.
Objectives of VCDs. The principal objective of any and all devices designed to “close the gap” and seal an arterial puncture site, large or small, is to prevent bleeding from the site. A byproduct of successful sealing of the artery is to then be able to ambulate the patient without fear of leaking around the VCD, and/or to avoid other access-site complications. Interestingly, the currently approved VCDs have been reliably associated with a shorter time to local hemostasis, and ambulation, even with large-bore arteriotomies.7 However, a small fraction of device deployments fail or are suboptimal, and the objective of significantly fewer bleeding complications after VCD use has not been realized.8
Methodology. In attempting to reduce adverse events, the Vascade device, similar to the currently approved Mynx device, achieves hemostasis without leaving any foreign body or material inside the vessel lumen. The Vascade expandable nitinol disk that locates the vessel wall and provides temporary hemostasis is retractable. There are no intravascular components. However, two problems remain with this design that may dilute the benefits if and when Vascade gets approval for clinical use: (1) the disc that locates the vessel wall can get “trapped” by a calcific plaque several millimeters upstream (craniad) from the actual puncture site; and (2) with suture-based devices, hemostasis and device malfunction can be assessed after cinching the sutures with the guidewire still in the vessel lumen, so access is not lost. With the Vascade device, wire access has to be removed in order for the nitinol disk vessel locator to be deployed. Once the disc is retracted, access to the vessel is lost.
Results. Device and procedure success rates with Vascade were 98% and 100%, respectively. Minor adverse events were 1.1% for Vascade and 7% for manual closure (MC). For better or worse, no major access-site related complications were reported in either arm of this trial. This dramatic 5.9% absolute risk reduction in minor complications is the best seen so far with VCDs and sets a new bar for future trials. However, detailed review of the patient cohort in RESPECT generates some concern regarding the reproducibility of these results in a broader catheterization lab population. Would the same reduction in minor adverse events still be observed if unfractionated heparin (UFH) was the routine anticoagulant instead of bivalirudin? Also, it appears that UFH was used for many of the diagnostic cases. Would any superiority with Vascade be observed in labs that do NOT routinely use any anticoagulants for routine, quick, diagnostic cases? The mean body mass index of 30 kg/m2 in RESPECT could also bias the results. One is left wondering what the deployment success and complication rates would be in the smaller body weight patients who we know are the patients at highest risk for bleeding. Lastly, would the Vascade strategy be equally effective in patients with ST-elevation myocardial infarction, many of whom are still treated with adjunctive intravenous glycoprotein IIb/IIIa therapy?
In the absence of any major bleeding events, is the RESPECT trial just another underpowered clinical trial? Does the absence of evidence allow us to intuit that there is evidence of absence of liability from major bleeding with this device?
Conclusion. Vascade use reduced the rate of minor access site-related complications, and significantly shortened time to hemostasis, ambulation, and eligibility for discharge compared to MC. While there was no formal economic analysis, the RESPECT trial presents us with a win-win proposition in the current medical environment of optimizing resource utilization, and reducing length of stay. Even without data on major bleeding, the impact of reducing minor complications, considering the global use of VCDs9 would be massive.
Future challenges. Catheterization laboratories in the United States and around the world are becoming more comfortable with adopting alternative access-sites, especially the radial artery approach.10 Large-bore arteriotomies for transcatheter aortic valve replacement or Impella-supported high-risk percutaneous coronary intervention are now routine worldwide.7 What will the clinical impact of a 5-7 Fr closure device be 2-3 years from now? Will any trials be conducted to assess the value of VCDs in brachial or axillary artery access sites?11
- Hermiller JB, Leimbach W, Gammon R, et al. A prospective, randomized, pivotal trial of a novel extravascular collagen-based closure device compared to manual compression in diagnostic and interventional patients. J Invasive Cardiol. 2015;27(3):129-137.
- Shammas NW, Rajendran VR, Alldredge GS, et al. Randomized comparison of VasoSeal and AngioSeal closure devices in patients undergoing coronary angiography and angioplasty. Catheter Cardiovasc Interv. 2002;55(4):421-425.
- Starnes BW, O’Donnell SD, Gillespie DL, et al. Percutaneous arterial closure in peripheral vascular disease: a prospective randomized evaluation of the Perclose device. J Vasc Surg. 2003;38(2):263-271.
- Hermiller JB, Simonton C, Hinohara T, et al. The StarClose vascular closure system: interventional results from the CLIP study. Catheter Cardiovasc Interv. 2006;68(5):677-683.
- Wong SC, Bachinsky W, Cambier P, et al. A randomized comparison of a novel bioabsorbable vascular closure device versus manual compression in the achievement of hemostasis after percutaneous femoral procedures: the ECLIPSE (Ensure’s Vascular Closure Device Speeds Hemostasis Trial). JACC Cardiovasc Interv. 2009;2(8):785-793.
- Biancari F, D’Andrea V, Di Marco C, et al. Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J. 2010;159(4):518-531.
- Tayal R, Amponsah M, Umkanthan K, Baker G, Cohen M, Wasty N. Safety and efficacy of a hybrid closure technique in large bore arteriotomies. Catheter Cardiovasc Interv. 2014;83:(Suppl 1):S240.
- Nikolsky E, Mehran R, Halkin A, et al. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis. J Am Coll Cardiol. 2004;44(6):1200-1209.
- Global Market for Vascular Closure Devices, US, Europe and the rest of the word. Life Science Intelligence. Nov, 2011.
- Agostoni P, Biondi-Zoccai GG, de Benedictis ML, et al. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures. Systematic overview and meta-analysis of randomized trials. J Am Coll Cardiol. 2004;44(2):349-356.
- Tayal R, LeSar B, Patel R, et al. A comparative analysis of axillary artery diameter and common femoral artery diameter: implications in transcathether aortic valve replacement (TAVR). Catheter Cardiovasc Interv. 2015 (in press).
From the Division of Cardiology, Cardiac Catheterization Lab, Newark Beth Israel Medical Center, Newark, New Jersey.
Disclosure: The author has completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The author reports no conflicts of interest regarding the content herein.
Address for correspondence: Marc Cohen, MD, FACC, Division of Cardiology, Cardiac Catheterization Lab, Newark Beth Israel Medical Center, 201 Lyons Avenue, Newark, NJ, 07112. Email: MARCohen@barnabashealth.org