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Perclose ProGlide™ Closure Device for Electrophysiologists

Early Ambulation.
Improved Efficiency.
Same-Day Discharge.

With the Perclose ProGlide™ Suture-Mediated Closure (SMC) System, immediate and durable hemostasis is achieved while the patient is still under your care, allowing for early ambulation and even same-day discharge. And you will be available to take care of more patients on your schedule.

Continue reading below to learn more about how Perclose ProGlide™ SMC System can lead to a swifter recovery and more efficiency with your patient load.

PERCLOSE PROGLIDE™ SUTURE-MEDIATED CLOSURE FOR EP ABLATION PROCEDURES

How the Perclose ProGlide™ Closure Device Affects EP Labs

The electrophysiologists (EPs) performing atrial fibrillation ablations may choose the Perclose ProGlide™ Suture-Mediated Closure (SMC) System for greater efficiency in the EP lab. Among vascular closure devices, Perclose ProGlide™ closure can offer benefits for the EP lab including:

  • Complete hemostasis of the access site in minutes,1,2 not hours
  • Patient ambulation in 2 hours1
  • Same-day patient discharge

The Perclose ProGlide™ vascular closure device has the broadest indication* for venous and arterial sheaths. In addition, this VCD also has a proven and trusted track record from more than 10 million repairs over the last 25 years.3

Rethinking Access Site Management:
Before and After Choosing the Perclose ProGlide™ Device

Without Perclose ProGlide™ the post-ablation recovery process is lengthy
Perclose ProGlide™ Rapid Time to Hemostasis Improves EP Lab Workflow with Same Day Discharge

Before: More Closure-Related Interventions Mean More Staff Time

Prior to adopting Perclose ProGlide™ SMC system closure, EPs completing an atrial fibrillation ablation or other procedures may find that patients require:

  • Multiple venous sheaths and access sites4
  • Uninterrupted anticoagulation: activated clotting time (ACT) ≥ 300 seconds5,6
  • Manual compression at groin access site for up to 30 minutes5
  • Protamine sulfate to reverse the effects of heparin7
  • Figure-of-eight (FO8) to maintain hemostasis5
  • Prolonged immobilization/bedrest of 4-12 hours to prevent bleeding and complications5
  • A Foley catheter8
  • Discharge 245-726 hours after the procedure

Using Perclose ProGlide™ Device: Improved EP Lab Workflow, Enhanced Patient Experience

The Perclose ProGlide™ closure device transforms an otherwise lengthy patient recovery to a much shorter recovery time, which in turn leads to a positive patient experience:

  • Time to hemostasis (TTH) is ~6 minutes10
  • Time to ambulation (TTA) is 2 hours1
  • Patients can go home the same day

 

Time to Ambulation: Per the IFU, patients may be ambulated 2 hours after the Perclose ProGlide™ SMC System procedures using 5-8F sheaths. For sheaths > 8F, ambulation time is at the physician’s discretion.

 

The rapid time to hemostasis allows EPs to verify the status of the closure while the patient is still under their care, enhancing confidence in the entire procedure from access to closure. Moreover, it’s potentially beneficial to the EP lab and hospital staff when patients are quickly ambulating, freeing up beds, and discharged the same day.

Impact of Faster Hemostasis and Patient Discharge on the EP Lab: Greater Efficiency, Lower Costs, Better Patient Experience

Early Ambulation and Same-Day Discharge for Atrial Fibrillation Ablation Cases

EP notes advantages of Perclose ProGlide™ SMC closure device

Sumit Verma, MD, an electrophysiologist from Baptist Heart and Vascular Institute, describes how that center altered its atrial fibrillation ablation protocol by implementing same-day discharge. He discusses how this strategy has the potential to reduce the complication rates, minimize resource use, and enable cost savings—all while enhancing patient satisfaction.13

See more Perclose ProGlide™ clinical data showing EP lab efficiency.

 

The use of Perclose ProGlide™ Suture-Mediated Closure System can help:

PerClose ProGlide™ for Large-Bore Closure Increases EP Lab Efficiency

SOURCE: S. Verma. Adopting a Strategy of Early Ambulation and Same-Day Discharge for Atrial Fibrillation Ablation Cases - EP Lab Digest - May 2019.

 

The Benefits of Suture-Mediated Repair for Vessel Closure

The Perclose ProGlide™ closure device achieves rapid hemostasis of femoral access sites by approximating the edges of the vessel wall with a surgical suture. The benefits of suture-mediated repair include promoting primary intention healing with less scarring14 and decreased time to hemostasis, ambulation, and patient discharge.15,16

Suture-Mediated Repair with Perclose ProGlide™

Benefits of suture-mediated repair with Perclose ProGlide™

Primary Intention Healing

Perclose ProGlide™ suture-mediated repair promotes healing and decreases time to hemostasis

Case Recordings

Each of these brief videos offers details of multiple device deployment using the Perclose ProGlide™ closure device.

Perclose ProGlide™ video with Brett Gidney, MD

AFib RF Ablation with
4x Venous Access Sites
Brett Gidney, MD
Santa Barbara, U.S.

Perclose ProGlide™ video with Brett Gidney, MD

AFib RF Ablation with
4x Venous Access Sites
Hemanth Ramanna, MD
The Hague, The Netherlands

Perclose ProGlide™ video with Brett Gidney, MD

2x Large-Bore Vascular Closure
Magnus Settergren, MD
Solna, Sweden


More case video recordings are available, with physicians offering additional details about their use of the Perclose ProGlide™ device.

 

FUN FACTS

For easy reference, view our infographic to understand how Perclose ProGlide™ SMC System can help deliver more efficient quality care.

 

 

Frequently Asked Questions

  • Why would I want to use a vessel closure device (VCD) in a vein?

    Using a VCD has several advantages given the following factors during EP procedures such as AF ablations:

    • Physicians often have multiple access sites to manage, even some involving large caliber venous sheaths.
    • Patients often receive full-dose peri-procedural anticoagulation, and this can make complete hemostasis a challenging and lengthy process, requiring prolonged immobilization.
    • The typical EP lab post-procedure process requires the patient to remain immobilized for prolonged periods of time, which is a source of patient discomfort.

    All of these issues are mitigated when using the Perclose ProGlide™ closure device.

  • Is Same-Day Discharge after AF ablations safe?
    Yes, Same-Day Discharge has been shown to be safe, and it is being used to reduce the total cost of care and to enhance the patient experience. The use of vessel closure devices makes it possible for hospitals to implement Same-Day Discharge.13,17,18
  • What makes Perclose ProGlide™ SMC System different from other vascular closure devices?

    With the Perclose ProGlide™ device you can achieve and confirm complete hemostasis on the table with a suture-mediated repair of the access site. Other advantages of the Perclose ProGlide™ SMC System include:

    • The broadest indication* for use in both common femoral veins and arteries
    • No ACT-level requirements, so reversal of heparin is not required in order to achieve immediate and durable hemostasis

    Find out more about primary healing with the Perclose ProGlide™ vessel closure device.

  • For what range of sheath sizes and devices can the Perclose ProGlide™ SMC System be used?

    The Perclose ProGlide™ closure device is indicated for use with:

    • Venous sheaths 5-24F1 (Max. OD 29F19 / 0.378 inches / 9.59 mm)
    • Arterial sheaths 5-21F1 (Max OD 26F19 / 0.340 inches / 8.62 mm)
  • Does the Perclose ProGlide™ device come in different sizes?
    No, there is only one Perclose ProGlide™ SMC System. Multiple Perclose ProGlide™ devices can be used, if necessary, for large-bore vascular closure.
  • How quickly can a patient be mobilized, ambulated, and discharged when using the Perclose ProGlide™ closure device?

    Because this device achieves immediate and durable hemostasis, patients can be mobilized and ambulated after approximately two hours (at the physician's discretion). Some facilities have successfully implemented a Same-Day Discharge strategy when using the Perclose ProGlide™ SMC System.

    For more details you can read a recent EP Lab Digest article by Sumit Verma, MD, or you can view a Perclose ProGlide™ video featuring Brett Gidney, MD.

  • How does the Perclose ProGlide™ SMC System achieve immediate and durable hemostasis?
    It achieves hemostasis by approximating the edges of the vessel wall with a surgical suture, allowing primary intention healing to begin. Primary intention healing minimizes scarring and allows for immediate reaccess if needed. View primary intention healing images with vessel closure device.
  • When using multiple sheaths in the same access site, which order and direction is recommended?

    This is a personal preference. Some operators use caudal to cranial approach—or vice versa—to keep the process consistent. 

    You can also view one or more physician case recordings using multiple sheaths.

  • What is the "Pre-Close" Technique?
    The "Pre-Close" Technique involves the Perclose ProGlide™ suture being placed around the access site before the index procedure, and it is required before using sheath sizes > 8F.
    See the Deployment Tab and Instructions for Use for additional information.
  • What should I do if a suture breaks?
    Each Perclose ProGlide™ device has a polypropylene monofilament suture with a pre-formed knot which has a tensile strength high enough to approximate the edges of the vessel wall. This suture can snap with quick and jerky movements. You can avoid suture break with the use of slow, consistent, increasing tension. Refer to the Tips and Technique: Suture Break section of the Deployment tab.

 

Visit the official Perclose ProGlide™ website for more information on the features, deployment, clinical data, Perclose ProGlide™ videos, and ordering information related to Perclose ProGlide™ SMC System.

  • References

    *As compared to Angio-Seal,‡ ExoSeal,‡ FemoSeal,‡ InClosure,‡ MANTA,‡ Mynx,‡ PerQseal,‡ Vascade,‡ Velox CD,‡ X-Seal‡. Data on file at Abbott.

    1. Abbott Perclose ProGlide Suture-Mediated Closure (SMC) System Instructions for Use. Data on file at Abbott.
    2. Sekhar A, et al. Femoral arterial closure using ProGlide™ is more efficacious and cost-effective when ambulating early following cardiac catheterization. Int J Cardiol Heart Vasc. 2016;13:6-13. doi: 10.1016/j.ijcha.2016.09.002.
    3. 10 million repairs based on Jan. 2020 Finance Report. 25 years based on Nov, 8, 1993 [Perclose] patent was filed for percutaneous suture vascular closure device. The Perclose portfolio includes all percutaneous suture devices. Data on file at Abbott.
    4. Gupta S. I Just Need Some Closure: Getting Past Using Manual Compression After Ablation. HRS 2018.
    5. Lakshmanadoss U, et al. Figure-of-eight suture for venous hemostasis in fully anticoagulated patients after atrial fibrillation catheter ablation. Indian Pacing Electrophysiol J. 2017;17:134-139. doi: 10.1016/j.ipej.2017.02.003
    6. Okada M, et al. Efficacy and safety of figure-of-eight suture for hemostasis after RFCA for AF. Circ J. 2018;82:956-964. doi: 10.1253/circj.CJ-17-1213.
    7. Ghannam M, et al. Protamine to expedite vascular hemostasis after catheter ablation of atrial fibrillation: A randomized controlled trial. Heart Rhythm. 2018;15(11):1642-1647. doi: 10.1016/j.hrthm.2018.06.045.
    8. Mohanty S, et al. Venous access-site closure with vascular closure device vs. manual compression in patients undergoing catheter ablation or left atrial appendage occlusion under uninterrupted anticoagulation. EP Europace. 2019;21:1048-1054. doi.org/10.1093/europace/euz004.
    9. Calkins H, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017;14(10):e275-e444. http://dx.doi.org/10.1016/j.hrthm.2017.05.012.
    10. Kar S, et al. The use of the Perclose ProGlide™ suture mediated closure (SMC) device for venous access-site closure up to 24F sheaths. CRT-200.28 JACC Cardiovasc Interv. 2018;11(4 suppl):S35. doi.org/10.1016/j.jcin.2018.01.112.
    11. Mahadaven VS, et al. Pre-closure of femoral venous access sites used for large-sized sheath insertion with the Perclose device in adults undergoing cardiac intervention. Heart. 2008;94:571-572. doi.org/10.1136/hrt.2006.095935.
    12. Sairaku A, et al. Rapid hemostasis at the femoral venous access site using a novel hemostatic pad containing kaolin after atrial fibrillation ablation. J Interv Card Electrophysiol. 2011;31:157-164.
    13. Verma S. Adopting a strategy of early ambulation and same-day discharge for atrial fibrillation ablation cases. EP Lab Digest. 2019;19(5).
    14. Mercandetti M. Wound Healing and Repair. Medscape. Accessed February 26, 2020. https://emedicine.medscape.com/article/1298129-overview
    15. Bhatt DL, et al. Successful “pre-closure" of 7Fr and 8Fr femoral arteriotomies with a 6Fr suture-based device (the Multicenter Interventional Closer Registry). Am J Cardiol. 2002;89:777-779.
    16. Applies to arterial access.
    17. Bartoletti S, Mann M, Gupta A, et al. Same‐day discharge in selected patients undergoing atrial fibrillation ablation. Pacing Clin Electrophysiol. 2019;42:1448-1455.
    18. Deyell M, Macle L, Khairy P, et al. The efficacy of a same-day discharge protocol after atrial fibrillation ablation. Canadian J Cardiol. 2018;34:(10 suppl):S84. doi:https://doi.org/10.1016/j.cjca.2018.07.281.
    19. Tests performed by and data on file at Abbott.

     

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