CARDIOVASCULAR
hamburger
Perclose ProGlide™ Closure Device for Electrophysiologists

WHEN YOUR PATIENTS ARE UP — SO ARE THEIR SPIRITS.

With Perclose ProGlide™ SMC System, immediate and durable hemostasis is achieved while under your care, allowing you to ambulate the patient sooner so they can be up and walking to the bathroom or to their car to be driven home the same day.

Continue reading below to learn more about how Perclose ProGlide™ SMC System can lead to a swifter recovery and more satisfied patients.

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 Recording

This brief video illustrates multiple device deployment of the Perclose ProGlide™ device in an EP ablation procedure.

Perclose ProGlide™ video with Brett Gidney, MD

AFib RF Ablation with
4x Venous Access Sites
Brett Gidney, MD
Santa Barbara, California

 

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.
  • What kind of training is available to begin using the Perclose ProGlide™ SMC System?

    Sign up for Abbott Education Network’s Vascular Closure Resource Center.

  • 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 a physician case recording 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 Multiple Device Deployment Tab and Instructions for Use for additional information.

 

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.

     

IMPORTANT SAFETY INFORMATION
CLICK HERE TO BEGIN TRAINING

IMPORTANT SAFETY INFORMATION

Rx Perclose ProGlide™ Suture-Mediated Closure (SMC) System

INDICATIONS

The Perclose ProGlide™ SMC System is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access site of patients who have undergone diagnostic or interventional catheterization procedures.
The Perclose ProGlide™ SMC System is used without or, if required, with adjunctive manual compression.
For access sites in the common femoral artery using 5F to 21F sheaths.
For access sites in the common femoral vein using 5F to 24F sheaths.
For arterial and venous sheath sizes greater than 8F, at least two devices and the pre-close technique are required.

CAUTION

Federal law restricts this device to sale by or on the order of a physician (or allied healthcare professionals, authorized by, or under the direction of, such physicians) who is trained in diagnostic and / or interventional catheterization procedures and who has been trained by an authorized representative of Abbott Vascular.

Prior to use, the operator must review the Instructions for Use and be familiar with the deployment techniques associated with the use of this device.

During closure of access sites using a procedural sheath greater than 8F it is recommended that a vascular surgeon or a surgeon with vascular training be available in case surgical conversion to control bleeding and to close the vessel is needed.

CONTRAINDICATIONS

There are no known contraindications to the use of this device. Attention is drawn to the WARNINGS and PRECAUTIONS sections.

WARNINGS

Do not use the Perclose ProGlide™ SMC device or accessories if the packaging or sterile barrier has been previously opened or damaged or if the components appear to be damaged or defective.

DO NOT RESTERILIZE OR REUSE. The Perclose ProGlide™ SMC device and accessories are intended for single use only.

Do not use the Perclose ProGlide™ SMC System if the sterile field has been broken where bacterial contamination of the sheath or surrounding tissues may have occurred, since such a broken sterile field may result in infection.

Do not use the Perclose ProGlide™ SMC System if the puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and / or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma. Perform a femoral angiogram to verify the location of the puncture site. NOTE: This may require both a Right Anterior Oblique (RAO) and Left Anterior Oblique (LAO) angiogram to adequately visualize where the sheath enters the femoral artery or vein.

Do not use the Perclose ProGlide™ SMC System if the puncture is through the posterior wall or if there are multiple punctures, since such punctures may result in a hematoma or retroperitoneal bleed.

Do not use the Perclose ProGlide™ SMC System if the puncture site is located in the superficial femoral artery or the profunda femoris artery, or the bifurcation of these vessels, since such puncture sites may result in a pseudoaneurysm, intimal dissection, or an acute vessel closure (thrombosis of small artery lumen). Perform a femoral angiogram to verify the location of the puncture site. NOTE: This may require both a Right Anterior Oblique (RAO) and Left Anterior Oblique (LAO) angiogram to adequately visualize where the sheath enters the femoral artery or vein.

PRECAUTIONS

1. Prior to use, inspect the Perclose ProGlide™ SMC System to ensure that the sterile packaging has not been damaged during shipment. Examine all components prior to use to verify proper function. Exercise care during device handling to reduce the possibility of accidental device breakage.

2. As with all catheter-based procedures, infection is a possibility. Observe sterile technique at all times when using the Perclose ProGlide™ SMC System. Employ appropriate groin management, as per hospital protocol, post procedure and post hospital discharge to prevent infection.

3. Use a single wall puncture technique. Do not puncture the posterior wall of the vessel.

4. Do not deploy the Perclose ProGlide™ SMC device at an angle greater than 45 degrees, as this may cause a cuff miss.

5. There are no reaccess restrictions if previous access site repairs were achieved with Abbott Vascular SMC devices.

6. If significant blood flow is present around the Perclose ProGlide™ SMC device, do not deploy needles. Remove the Perclose ProGlide™ SMC device over a 0.038" (0.97mm) (or smaller) guidewire and insert an appropriately sized introducer sheath.

7. When pushing the plunger assembly to advance the needles, stabilize the device to ensure the device does not twist or move forward during deployment. Twisting the device could lead to needle deflection resulting in a cuff miss. Do not use excessive force or repeatedly push the plunger assembly. Excessive force on the plunger during deployment could potentially cause breakage of the device, which may necessitate intervention and / or surgical removal of the device and vessel repair.

8. Do not apply excessive force to the lever when returning the foot to its original position (marked #4) down to the body of the device. Do not attempt to remove the device without closing the lever. Excessive force on the lever of the device or attempting to remove the device without closing the lever could cause breakage of the device and / or lead to vessel trauma, which may necessitate intervention and / or surgical removal of the device and vessel repair.

9. Do not advance or withdraw the Perclose ProGlide™ SMC device against resistance until the cause of that resistance has been determined (see Section 11.3 Single SMC DEVICE PLACEMENT section). Excessive force used to advance or torque the Perclose ProGlide™ SMC device should be avoided, as this may lead to significant vessel damage and / or breakage of the device, which may necessitate intervention and / or surgical removal of the device and vessel repair.

10. If excessive resistance in advancing the Perclose ProGlide™ SMC device is encountered, withdraw the device over a 0.038" (0.97 mm) (or smaller) guidewire and reinsert the introducer sheath or use manual compression.

11. Remove the Perclose ProGlide™ sheath before tightening the suture. Failure to remove the sheath prior to tightening the suture may result in detachment of the tip of the sheath.

13. During closure of access sites using a 5 – 8F procedural sheath, use manual compression in the event that bleeding from the femoral access site persists after the use of the Perclose ProGlide™ SMC device.

14. During closure of access sites using a procedural sheath > 8F, in the event that bleeding from the femoral access site persists after the use of the Perclose ProGlide™ SMC devices, the physician should assess the situation. Based on the physician assessment of the amount of bleeding use manual compression, compression assisted devices and / or a surgical repair to obtain hemostasis.

15. During closure of access sites using a procedural sheath > 8F, in those cases where the implanting physician is not a vascular surgeon, it is recommended that a vascular surgeon or a surgeon with vascular training be available during the procedure to perform any necessary surgical intervention.
 

POTENTIAL ADVERSE EVENTS

Potential adverse events associated with use of suture mediated closure devices may include, but are not limited to, the following:

  • Allergic reaction or hypersensitivity to device components
  • Anemia
  • Arterial stenosis / occlusion
  • Arteriovenous fistula
  • Bleeding / hemorrhage
  • Bruising / hematoma
  • Death
  • Deep vein thrombosis
  • Device entrapment
  • Device failure / malfunction / misplacement
  • Diminished pulses distal to closure site
  • Embolism
  • Hypotension / hypertension
  • Infection / sepsis
  • Inflammation
  • Intimal tear / dissection
  • Ischemia distal to closure site
  • Nerve injury
  • Numbness
  • Pain
  • Perforation
  • Pseudoaneurysm
  • Pulmonary embolism
  • Retroperitoneal hematoma / bleeding
  • Thrombus formation
  • Vascular injury
  • Vasoconstriction / vasospasm
  • Vasovagal episode
  • Wound dehiscence

MAT-2002003 v1.0

DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.

True
accessibility
© 2019 Abbott. All Rights Reserved. Please read the Legal Notice for further details.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

accessibility

DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.