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Cardiovascular

Perclose™ ProStyle™

Suture-Mediated Closure And Repair System

Deployment & Suture Management

Device Preparation


 To prep the device, verify Marker Lumen patency by flushing it with saline until saline exits the Marker Port.


4 Key Steps to Suture Deployment

1. Advance device & lift Lever (Open Foot)


2. Maintain retraction and depress Plunger (Deploy Needles)



3. Pull back Plunger (Deploy Suture)



4. Lower Lever (Close Foot)

Suture Management


 A. Load the blue (rail) suture limb in the Snared Knot Pusher (or in the Suture Trimmer) and advance the Suture Knot


B. Lock Suture Knot by pulling white (non-rail) suture limb


C. Trim suture limbs by pulling Trimming Lever

Single and Multiple Device Deployment

View the animation library for System Overview, Device Preparation, and full deployment steps for Single Device Deployment and Multiple Device Deployment techniques.

Single Device Deployment

Multiple Device Deployment


Single and Multiple Device Deployment

Foot Break

 Causes/Observations


 Potential causes during Plunger deployment (Step 2)
  • Rotating/rocking the device or excessive force during Plunger deployment
  • Shallow (less than 45º) Plunger deployment angle
Potential observations after Plunger removal (Step 3) and/or device removal
  • No Suture or link present
  • Just a link and no Suture present
  • Missing part of Foot when the device is removed


Deployment Angle During plunger deployment (Step 2)
 Shallow Deployment Angle
  • Sub-optimal in any tissue conditions
  • Potential gap between Posterior Foot and vessel wall increases chance for foot break and cuff miss


45º Deployment Angle
  • Ideal in healthy compliant tissue conditions
  • Posterior and Anterior Foot appose evenly to compliant vessel wall

Foot Break Prevention
  1. Position the Perclose™ device at 45º angle and keep stable with the left hand during Plunger deployment
    • The deployment angle may vary slightly depending on anatomy

  2. Maintain even and gentle tension over the Anterior and Posterior Foot against the vessel wall
    • The key is to raise the device until pressure is evenly distributed across the Anterior and Posterior Foot

  3. Press down on the Plunger with a gentle, increasing pressure to advance the Needles
    • The Needles are more susceptible to deflecting off calcification with higher Plunger force and higher Needle speed

Foot Break Prevention



 Before attempting to remove the device:
  • Relax the device before pushing the Lever down
  • Push the Lever down to return Foot to the closed position


Device Entrapment

Observations

Difficult or unable to lower the Lever (close the Foot) and remove device after the Suture Deployment


Causes & Prevention

Potential Causes Prevention
  1. Separation of Proximal Guide & Distal Guide due to excessive pressure buildup during device advancement
  • If excessive resistance is felt during device advancement, gently roll device medially and laterally to ease device entry.
  1. Separation of Proximal Guide & Distal Guide due to excessive device rotation prior to Step 1 (before Open Foot)
  • Only rotate device up to 30°  from the 12 o’clock position, especially in diseased non-compliant tissue conditions.
  1. Separation of Proximal Guide & Distal Guide due to excessive device rotation after Step 1 (with Open Foot)
  • Complete device rotation, if necessary, before performing Step 1 (Open Foot).
  1. Malfunction of Lever-Foot wire control mechanism due to excessive retraction force during suture deployment
  • Maintain gentle retraction against the vessel wall when depressing Plunger to deploy needles (Step 2).
  • Relax device when lowering Lever (Step 4) to close the Foot.
  • Advance device slightly to restore marker flow, if necessary, before lowering the Lever.
  1. Unable to close Foot due to tissue interference between Distal Guide and Posterior Foot
  • Stop device advancement once “mark” is observed from the Marker Lumen to ensure the Foot is open (Step 1) near or at the access site to minimize intraluminal travel during pull back for Step 2


Cuff Miss
  • Plunger is withdrawn and no Suture is present. The link may or may not be attached to Anterior Needle
  • Tip(s) of Needle(s) did not lock with Cuff(s)


Prevention
  • Proper patient selection
  • Deploy device at 45º angle
  • Maintain gentle retraction against the vessel wall
  • Stabilize device with left hand during Plunger deployment
  • Ensure black Collar on Plunger contacts the device Body
  • Maintain and stabilize the device at 45º angle throughout removal of Plunger/Needles and until Suture is fully retracted
Resolution
  • Insert wire and exchange for another device


Suture Break

Causes/Prevention
  • Suture may look thin and elongated
  • Rail or non-rail limbs can break



  • Load Suture at mid-point of Suture Trimmer (Do not load at tip)
  • Keep Thumb Knob retracted until Suture limbs drop into Suture Gate (Do not close Suture Gate on the Suture)


  • Keep Thumb Knob toward ceiling (Do not rotate Suture Trimmer)
  • Keep suture limbs coaxial to Suture Trimmer and tissue tract at all times
  • Do not pull laterally or medially on Suture
  • Apply slow, consistent, increasing tension (Avoid quick, jerky movements)


Poor Flow
Poor Arterial Flow / No Flow
Resolution
Marker Port against vessel wall
  • Do not deploy Perclose™ devices with vessel diameters <5 mm

Side wall stick
  • Gently rotate device to move Marker Port off vessel wall

Low blood pressure
  • Slow drip is acceptable if Perclose™ device position is confirmed

Clot or tissue plugging Marker Port
  • Retract device until Marker Port is above skin. Re-flush Marker Lumen and observe saline exit Marker Port

Device not in vessel lumen
  • Drip can occur when Marker Port is near vessel lumen but not completely in the vessel, especially with high blood pressure or 7/8F sheaths
  • Continue advancing the Perclose™ device until brisk pulsatile flow is observed

Poor Venous Flow / No Flow




 Resolution
No flow is possible and acceptable if device location is confirmed
  • Apply pressure on groin or lower abdomen
  • Inject contrast through Marker Lumen
  • Use ultrasound to confirm location of device
  • Have the patient perform the Valsalva maneuver

Marker Port against vessel wall
  • Small vessel diameter; if not 5 mm vessel, do not deploy

Side wall stick
  • Gently rotate device to move Marker Port off vessel wall

Low blood pressure
  • Slow drip is acceptable in vein

Clot or tissue plugging Marker Port
  • Retract device until Marker Port is above skin. Re-flush Marker Lumen and observe saline exit Marker Port

Device not in vessel lumen
  • No flow can occur when Marker Port is near vessel lumen but not completely in the vessel
  • Continue inserting device until slow drip occurs

Lack of Hemostasis
Lack of hemostasis may be a result of incorrect order of knot advancement or tangled sutures.

Incorrect Order of Knot Advancement

  • Advance Sutures in the order of deployment





Tangled Sutures
  • After initial knot advancement of all Sutures, continue to tighten and lock each knot in the order deployed
  • Tightening and locking the Second Suture before the First Suture is completely secure can result in an incomplete or "partial" close

  • After Suture Deployment, a clamp is immediately placed on the Suture limbs. A gentle retraction is placed on the clamp until the Suture is taut. This removes all Suture slack from the tissue tract



  • If Suture slack is not removed, the Sutures can become tangled or pushed into the vessel during insertion of procedural sheaths and device exchanges




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* (SAPTĖ„ 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

*As compared to Angio-Seal‡, ExoSeal‡, FemoSeal‡, MANTA‡, Mynx‡, PerQseal‡, VASCADE‡. Data on file at Abbott.

  1. Perclose™ ProStyle™ SMCR System – Instructions for Use (IFU)
  2. For arterial sheath sizes greater than 8F, at least two devices and the pre-close technique are required.
  3. For venous sheath sizes greater than 8F, at least one device and the pre-close technique are required.
  4. Max. OD 26F/0.340 inches/8.62 mm; Max. OD 29F/0.378 inches/9.59 mm. Tests performed by and data on file at Abbott.
  5. Tests performed by and data on file at Abbott.
  6. Primary intention healing occurs where vessel wall edges are brought together, adjacent to each other. This can be achieved with suture, stitches, staples and clips. Advances in Skin & Wound Care: Healing by Intention. Salcido, Richard. 2017.
  7. Time to hemostasis, ambulation and discharge applies to the arterial access.
  8. Bhatt, Deepak L. et al. Successful “Pre-Closure” of 7Fr and 8Fr Femoral Arteriotomies With a 6Fr Suture-Based Device (The Multicenter Interventional Closer Registry). American Journal of Cardiology Vol 89. March 2002.
  9. Mercandetti, Michael. Wound Healing and Repair. Medscape. WebMD, 02 April 2019. Web. January 15, 2020.
  10. Perclose ProGlide™ Versus Surgical Closure Outcomes – Real World Evidence. Schneider, Darren B; Krajcer, Zvonimir; et al. LINC 2018.
  11. The Use of the Perclose ProGlide™ Suture Mediated Closure (SMC) Device for Venous Access-Site Closure up to 24F Sheaths. Kar, Saibal; Hermiller, James; et al. CRT 2018.

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