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Close Confidently.

The Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System provides the secure finish to your successful procedure, helping you to deliver better quality care to your patients:

  • Achieve immediate and durable haemostasis that enables same-day discharge13,15,16,20
  • Minimise the risk of access site-related post-procedural complications10,15,16
  • Enhance the recovery experience for your patients13,20

Learn more about how you can finish your procedure with confidence with the Perclose™ ProStyle™ SMCR System.

 

RETHINKING ACCESS SITE MANAGEMENT   |   IMPACT OF FASTER HAEMOSTASIS   |  
 BENEFITS OF SUTURE-MEDIATED REPAIR   |   CASE RECORDING   |   FAQ

 

PERCLOSE™ PROSTYLE™ SUTURE-MEDIATED CLOSURE FOR EP ABLATION PROCEDURES

How the Perclose™ ProStyle™ Closure Device Affects EP Labs

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

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

The Perclose™ ProStyle™ 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 12 million repairs for over 25 years.3

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

Before: More Closure-Related Interventions Mean More Staff Time

Prior to adopting Perclose™ ProStyle™ SMCR System, 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 haemostasis5
  • Prolonged immobilisation/bedrest of 4-12 hours to prevent bleeding and complications5
  • A Foley catheter8
  • Discharge 245-726 hours after the procedure

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

The Perclose™ ProStyle™ 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 haemostasis (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™ ProStyle™ SMCR System procedures using 5-8F sheaths. For sheaths > 8F, ambulation time is at the physician’s discretion.

 

The rapid time to haemostasis 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.

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Impact of Faster Haemostasis 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

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, minimise resource use, and enable cost savings—all while enhancing patient satisfaction.13

Read here

 

See more Perclose™ clinical data showing EP lab efficiency.

 

The use of Perclose™ ProStyle™ Suture-Mediated Closure and Repair System can help:

 

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

 

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The Benefits of Suture-Mediated Repair for Vessel Closure

The Perclose™ ProStyle™ closure device achieves rapid haemostasis 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 haemostasis, ambulation, and patient discharge.15,16

Suture-Mediated Repair with Perclose™ ProStyle™

Primary Intention Healing

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Case Recordings

 

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

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

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

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.

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FUN FACTS

For easy reference, view our infographic to understand how Perclose™ Family of VCDs can help deliver more efficient quality care.

Download Infographic

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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 haemostasis a challenging and lengthy process, requiring prolonged immobilization.
  • The typical EP lab post-procedure process requires the patient to remain immobilised for prolonged periods of time, which is a source of patient discomfort.

All of these issues are mitigated when using the Perclose™ ProStyle™ 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™ ProStyle™ SMCR System different from other vascular closure devices?

With the Perclose™ ProStyle™ device you can achieve and confirm complete haemostasis on the table with a suture-mediated repair of the access site. Other advantages of the Perclose ProStyle™ SMCR 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 haemostasis

 

 

For what range of sheath sizes and devices can the Perclose™ ProStyle™ SMCR System be used?

The Perclose ProStyle™ 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™ ProStyle™ device come in different sizes?

No, there is only one Perclose™ ProStyle™ SMCR System. Multiple Perclose™ ProStyle™ devices can be used, if necessary, for large-bore vascular closure.

 

How quickly can a patient be mobilised, ambulated, and discharged when using the Perclose™ ProStyle™ closure device?

Because this device achieves immediate and durable hemostasis, patients can be mobilised 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™ ProStyle™ SMCR System achieve immediate and durable haemostasis?

It achieves haemostasis by approximating the edges of the vessel wall with a surgical suture, allowing primary intention healing to begin. Primary intention healing minimises scarring and allows for immediate reaccess if needed. 

 

What kind of training is available to begin using the Perclose™ ProStyle™ SMCR System?

Contact your local Abbott representative for a training opportunity.

 

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™ ProStyle™ suture being placed around the access site before the index procedure, and it is required before using sheath sizes > 8F.
See Deployment and Instructions for Use for additional information.

 

What should I do if a suture breaks?

Each Perclose™ ProStyle™ 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.

 

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

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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.
  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. 11 million repairs based on Nov. 2021 Finance Report. 27 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. https://dx.doi.org/10.1016/j.hrthm.2017.05.012.
  10. Kar, S., et al, The Use of Perclose ProGlide Suture-Mediated Closure (SMC) Device for Venous Access-Site Closure Up to 24F Sheaths. CRT 2018.
  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.
  20. Verma, S., et al, Feasibility and Safety of Same Day Discharge for Patients Undergoing Atrial Fibrillation (AF) Ablation in a Community Hospital Setting. HRS 2020 Science Online, May 2020.

 

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