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Experience versatility with the Health Canada approved vessel closure device to close access sites for ALL Pulsed Field Ablation (PFA) Systems.¥

Perclose™ ProStyle™ Suture-Mediated Closure for EP Ablation Procedures
The Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System enables an improved post-cardiac ablation experience:

  • Immediate and durable hemostasis with >96% freedom from major access site-related complications at 30 days1,Δ
  • Enhanced patient comfort and satisfaction1,13
  • Rapid ambulation and same-day discharge1
PercloseTM ProStyleTM has the broadest indication* for venous and arterial sheaths.
In addition, this vessel closure device also has a proven and trusted track record from more than 20 million repairs.3
Learn how you can finish your procedure with confidence with the Perclose™ ProStyle™ SMCR System.



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, atrial fibrillation, including pulsed field 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™ ProStyle™ Device: Improved EP Lab Workflow, Enhanced Patient Experience
The Perclose™ ProStyle™ closure device transforms an otherwise lengthy patient recovery to a shorter recovery time, which in turn leads to a positive patient experience:

  • Time to hemostasis (TTH) is 1 minute1§ per access site
  • Patient may sit up immediately; no lay-flat restrictions1
  • Time to ambulation (TTA) is >/1 hour1◊**
  • Patient may be eligible for same-day discharge ≥ 2 hours1◊**
§ observed median time to hemostasis per access site (DUS) IDE Trial
◊ As per the IFU, patients who have undergone cardiac arrhythmia treatments with multiple access sites in a single femoral vein of one or both limbs may be ambulated one hour or more and may be eligible for same-day discharge two hours or more after successful closures with Perclose™ devices based on the judgment of the physician.

The rapid time to hemostasis allows EPs to verify the status of the closure while the patient is still under their care1, 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: Potentially Greater Efficiency, Lower Costs, Better Patient Experience

Safety and effectiveness for closing multiple common femoral venous access sites per limb was demonstrated in a duplex ultrasound (DUS) IDE trial and three real-world investigator sponsored studies (ISS) with over 1,000 combined patients.

Click "Learn More" to find out more about these studies: Perclose Multi-Access Duplex Ultrasound (DUS) IDE Trial, Vascular Closure for Cardiac Ablation Registry (VACCAR), Emory School of Medicine (ESM) Study, Santa Barbara Cottage Hospital (SBCH) Study

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.

The Benefits of Suture-Mediated Repair for Vessel Closure
The Perclose™ ProStyle™ 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™ ProStyle™

Suture-Mediated Repair with Perclose™ ProStyle™






Frequently Asked Questions

Can Perclose™ ProStyle™ be used for vascular closure after Pulsed Field Ablation (PFA) for AFib?

Yes, Perclose™ ProStyle™ can be used in conjunction with a variety of atrial fibrillation ablation techniques, including Pulsed Field Ablation (PFA) Systems.

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.4
  • Patients often receive full-dose peri-procedural anticoagulation, and this can make complete hemostasis a challenging and lengthy process, requiring prolonged immobilization.5,6
  • 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.5
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.13,16,17,18

What makes Perclose™ ProStyle™ SMCR System different from other vascular closure devices?

With the Perclose™ ProStyle™ device you can achieve and confirm complete 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 hemostasis1,18
  • Patient may sit-up immediately after successful closure with Perclose™ device1
Find out more about primary healing with the Perclose ProStyle™ vessel closure device.

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 mobilized, ambulated, and discharged when using the Perclose™ ProStyle™ closure device?

Because this device achieves immediate and durable hemostasis, patients may sit-up immediately in bed. For cardiac arrhythmia treatments with multiple access sites, patients may be ambulated in as little as 1 hour and be eligible for same-day discharge as early as 2 hours after closure using Perclose™ devices.1

How does the Perclose™ ProStyle™ SMCR 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.1,14


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

Contact your local Abbott representative for a training opportunity.


What is the "Pre-Close" Technique?

The Pre-Close technique involves placing Perclose™ ProStyle™ sutures before the index procedure. For common femoral artery access sites using sheath sizes greater than 8F, and for common femoral vein access sites using sheath sizes greater than 14F, at least two devices and the Pre-Close technique are required.¹
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.

Resultados del Estudio XIENCE 28 y XIENCE 906

Stent XIENCE™ con DAPT a corto plazo: Eventos isquémicos

Entre los pacientes con alto riesgo de sangrado (HBR), el stent XIENCE™ con DAPT de 1 o 3 meses redujo el sangrado grave sin aumento en los eventos isquémicos, incluido el infarto de miocardio (IM) y todas las muertes.6

XIENCE 28: DAPT de 1 mes en pacientes con alto riesgo de sangrado (HBR)
XIENCE 28: Todas las muertes o IM

With XIENCE™ Stent, there is no increase in all death or MI using 1-month DAPT or 3-month DAPT vs 6-month DAPT or 12-month DAPT, respectively

XIENCE 90: DAPT de 1 mes en Pacientes con alto riesgo de sangrado (HBR)
XIENCE 90: Todas las muertes o IM

With XIENCE™ Stent, there is no increase in all death or MI using 1-month DAPT or 3-month DAPT vs 6-month DAPT or 12-month DAPT, respectively

 Stent XIENCE™ con DAPT a corto plazo: Reducción del sangrado severo

En la misma población de pacientes con alto riesgo de sangrado (HBR), el stent XIENCE™ con DAPT de 1 o 3 meses redujo el sangrado severo sin aumento en los eventos isquémicos.6,*

XIENCE 28: Sangrado BARC 3-5

With DAPT halted at either 1 month and 3 months, XIENCE™ Stent showed less severe bleeding, at 6 months and 12 months, vs earlier XIENCE™ Stent data

XIENCE 90: Sangrado BARC 3-5

With DAPT halted at either 1 month and 3 months, XIENCE™ Stent showed less severe bleeding, at 6 months and 12 months, vs earlier XIENCE™ Stent data

*El análisis estratificado por puntaje de propensión para el sangrado BARC 3-5 no fue preespecificado. BARC 2-5 fue un criterio de evaluación secundario reforzado para su significación estadística. En ambos estudios, para BARC 2-5, el stent XIENCE™ mostró una tasa de sangrado numéricamente menor para DAPT de 1 o 3 meses frente a una DAPT de 6 meses o DAPT de 12 meses, respectivamente.

Stent XIENCE™ con DAPT a corto plazo: Baja tasa continua de trombosis del stent

El stent XIENCE™ es reconocido por sus tasas bajas de trombosis del stent (ST), y es significativamente más tromborresistente que otros DES.7 Esto es evidente, incluso con datos de DAPT a corto plazo. El stent XIENCE™ con DAPT de 1 mes no mostró aumento en la ST frente a una DAPT de 6 meses, con una tasa de ST de 0.3%. De manera similar, el DAPT de 3 meses mostró una tasa de ST de 0.2%.6

XIENCE 28: Trombosis del stent (ST)

Entre 1 y 6 meses
ARC: ST Definitiva/Probable
El stent XIENCE™ con DAPT corto muestra tasas consistentemente bajas de trombosis del stent: DAPT de 1 y 6 meses son ambos de 0,3% ST, y DAPT de 3 y 12 meses son ambos de 0,2% ST.

XIENCE 90: Trombosis del stent (ST)

Entre 3 y 12 meses
ARC: ST Definitiva/Probable
El stent XIENCE™ con DAPT corto muestra tasas consistentemente bajas de trombosis del stent: DAPT de 1 y 6 meses son ambos de 0,3% ST, y DAPT de 3 y 12 meses son ambos de 0,2% ST.

El stent XIENCE™ es tromborresistente: Adecuado para la DAPT a corto plazo

El stent XIENCE™ también es reconocido por ser significativamente más tromborresistente que otros DES disponibles en el mercado. Como muestran los hallazgos del estudio, el stent XIENCE™ muestra significativamente menor adhesión plaquetaria (p<0.01) en comparación con otros DES — como se muestra en rojo en las imágenes de microscopía confocal. La adhesión plaquetaria es un factor importante en la trombosis del stent.*8 Estos hallazgos sugieren que esta elección de stent "puede ser idealmente adecuada para DAPT a muy corto plazo".8

*Modelo de desviación ex-vivo en cerdos.

XIENCE™ Stent is thromboresistant, showing significantly less (p < 0.01) platelet adhesion than Synergy,‡ Orsiro,‡ Ultimaster,‡ Onyx,‡ and BioFreedom‡ DES.

Estudios STOPDAPT: DAPT de 1 mes y 3 meses en una población general9,10

STOPDAPT9 y STOPDAPT 210 fueron ensayos prospectivos del stent XIENCE™ que estudiaron la interrupción de la DAPT a los 3 meses y 1 mes, respectivamente.

Ensayo STOPDAPT 2: DAPT de 1 mes superior a la DAPT de 12 meses10

El ensayo STOPDAPT 2 reveló que la DAPT de 1 mes demostró seguridad superior a la DAPT de 12 meses, para el criterio de valoración principal de eventos cardiovasculares adversos netos (NACE, por sus siglas en inglés). El NACE incluyó muerte cardiovascular, infarto de miocardio (IM), trombosis del stent (ST) definitiva, accidente cerebrovascular o hemorragia mayor/menor de trombosis en infarto al miocardio (TIMI, por sus siglas en inglés). Los 3,009 pacientes de este ensayo controlado y aleatorizado fueron tratados con el stent XIENCE™.10

NACE* significativamente menor con DAPT de 1 mes

With XIENCE™ Stent, 1-month DAPT is superior to 12-month DAPT for net adverse cardiovascular events

Sangrado significativamente menor* con DAPT de 1 Mes

With XIENCE™ Stent, there is significantly lower risk of bleeding events with 1-month DAPT vs 12-month DAPT

Tasas de eventos isquémicos comparables* con DAPT de 1 mes

With XIENCE™ Stent, 1-month DAPT and 12-month DAPT show comparable ischemic event rates of 2.0% to 2.5%

“Interrumpir la DAPT a los 3 meses en pacientes seleccionados después de la implantación [del stent XIENCE™] fue tan seguro como el régimen prolongado de DAPT adoptado en el grupo de control histórico.”

— Masahiro Natsuaki, MD, Ensayo STOPDAPT9

Diseño y aleatorización del Ensayo STOPDAPT 210

Exclusion criteria in STOPDAPT 2 included patients on oral anticoagulants, with a history of intracranial bleeding, and with major in-hospital complications such as MI, stroke or major bleeding

DAPT corto de 1 mes

  • 0 a 1-mes: Aspirina + P2Y12
  • Después de 1 mes: Monoterapia con clopidogrel
Exclusion criteria in STOPDAPT 2 included patients on oral anticoagulants, with a history of intracranial bleeding, and with major in-hospital complications such as MI, stroke or major bleeding

DAPT de 12 meses

  • 0 a 1 mes: Aspirina + P2Y12
  • 1 a 12 meses: Aspirina + Clopidogrel
  • 12 a 60 meses: Monoterapia con aspirina
Key inclusion criteria
  1. Intervención coronaria percutánea (ICP) exitosa utilizando un stent liberador de everolimus de cobalto-cromo: XIENCE™
  2. Candidato para DAPT (aspirina/inhibidor del receptor P2Y12) durante 1 año
Key exclusion criteria
  1. Pacientes que necesitan anticoagulantes orales
  2. Historial de hemorragia intracraneal
  3. Complicaciones importantes en el hospital (IM/accidente cerebrovascular/hemorragia mayor)

Ensayo STOPDAPT: La combinación del stent XIENCE™ con DAPT de 3 meses es factible9

STOPDAPT9 fue el primer ensayo prospectivo que estudió la interrupción de la DAPT a los 3 meses después de la implantación. Entre otros resultados a 1 año, la tasa de trombosis de stent con XIENCE™ fue de 0.0%.

El ensayo STOPDAPT demuestra la factibilidad de usar el stent XIENCE™ con DAPT de 3 meses9

XIENCE™ Stent 1-year data, when using 3-month DAPT, shows 0.0% definite or probable stent thrombosis

Conozca más acerca de STOPDAPT 2

“Vale la pena destacar que no se produjo ninguna trombosis de stent definitiva o probable en los pacientes tratados con XIENCE™ incluidos en STOPDAPT.”

— Masahiro Natsuaki, MD, Ensayo STOPDAPT9

STOPDAPT-3 Trial Design and Randomization11

Key inclusion criteria
  1. ICP con uso exclusivo y planificado de un stent liberador de everolimus (EES, por sus siglas en inglés ) de CoCr (XIENCE™)
  2. Presencia de paro cardíaco súbito (SCA, por sus siglas en inglés) o ARC-HBR
  3. Elegible para DAPT (aspirina/inhibidor P2Y12) durante 1 mes.

Diseño del estudio y aleatorización

Grupo 1:

0 a 1 mes: Aspirina + P2Y12 (Prasugrel)

Después de 1 mes: Monoterapia con clopidogrel

Grupo 2:

0 a 1 mes: P2Y12 (Prasugrel)

Después de 1 mes: Monoterapia con clopidogrel

El Ensayo STOPDAPT-311 se diseñó para estudiar la DAPT de 0 meses* (SAPT˄ utilizando solamente un inhibidor P2Y12) para pacientes con paro cardiaco súbito (SCA) y alto riesgo de sangrado (HBR).

Aunque los resultados son comparables tanto para hemorragias como para eventos isquémicos en los brazos de DAPT y TAPS, el estudio no cumplió con su criterio de valoración y concluyó en usar DAPT durante 1 mes después de la ICP.

Major bleeding
CV Death, MI, Definte ST, Ischemic Stroke
XIENCE Stent Efficacy

El stent XIENCE™ sigue siendo el ÚNICO DES con la indicación de DAPT más corta, que puede ser tan corta como 28 días.12

References
¥ At the time of publication.

† Indicated for closing multiple access sites in the same common femoral vein.

*As compared to Angio-Seal‡, ExoSeal‡, Celt ACD‡, MANTA‡, Mynx‡, Vascade‡. Data on file at Abbott.

** after successful close with Perclose device(s) in patients who have undergone cardiac arrhythmia treatments with multiple common femoral venous access sites
***observed in a duplex ultrasound (DUS) IDE trial and two real-world investigator sponsored studies.

  1. Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System Instructions for Use (IFU). Refer to IFU for additional information.
  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. 15 million+ repairs based on August 2022 Finance Report. 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 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. Fabbricatore D et al. Ambulatory PV isolation workflow using suture-mediated vascular closure devices: a prospective observational cohort study. (PRO-PVI Study).
  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. 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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