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Perforation Type 3 Device – Case 2

Clinical Presentation

  • 83-year-old female who presented with a NSTEMI.

Past Medical History

  • HTN, HLD, DM, CAD s/p 3 vessel CABG, AFIB, COPD, Hypothyroidism, GERD, Severe AS, Moderate MR, Moderate TR
  • LVEF 60%

Clinical Variables

  • Prior Cardiac Catheterization: Mid LAD CTO, proximal LCx 90% stenosis, RI CTO, proximal RCA CTO, and patent grafts.

Medications Heading

  • Home Medications: Warfarin, Pravastatin, Digoxin, Diltiazem CD, Losartan, Fluticasone-Salmeterol, Metformin, Ranitidine
  • Adjunct Pharmacotherapy: Clopidogrel, Heparin IV

Pre-procedure EKG Heading

Angiograms

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Left coronary artery angiography
  • 90-95% lesion in the proximal left circumflex (LCx) coronary artery
  • 70-80% stenosis in the first left posterolateral branch (LPL).
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Left coronary artery angiography

  • 90-95% lesion in the proximal left circumflex (LCx) coronary artery
  • 70-80% stenosis in the first left posterolateral branch (LPL).
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Right coronary artery (RCA) angiography

  • Total occlusion of the proximal RCA filling via a saphenous vein graft (SVG) to the right posterior descending artery (RPDA).
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LIMA to LAD graft angiography found no obstruction in the graft.

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Angiographically normal arterial graft to ramus intermedius (RI)

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BAV performed prior to proceeding forward with PCI.

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Multiple wires used to attempt to cross the LCx lesion followed by placement of a rota-wire.

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Pre-dilatation of the lesion with a Trek NC 2.5/15mm balloon (not shown) was performed followed by deployment of a Synergy 3.0/20mm stent in the distal LCx (shown).

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Pre-dilatation of the lesion with a Trek 3.5/12mm balloon (not shown). This was followed by positioning of Synergy 3.5/38mm stent in the proximal LCx and its inflation to a pressure of 20 atm. (shown).

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Angiography of the LCx after stent placement showing a type 3 mid-stent perforation.

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Deployment of a Jomed 4.0/16mm covered stent in the proximal LCx.

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Post-dilation of the Jomed covered stent placed in the proximal LCx with a Trek NC 3.5/12mm balloon.

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Repeat post-dilatation of the covered stent was performed using the same balloon with inflation to a higher pressure (20 atm) resulting in adequate sealing of the perforation.

Post-procedure EKG

Case Overview

  • Underwent BAV followed by intervention of the LCx.
  • When positioning the rota-wire through the LCx, it passed through the subintimal space; therefore, rotational atherectomy was deferred.
  • Procedure was continued and two stents were placed in the LCx with procedure being complicated by a type 3 mid-stent perforation.
  • Perforation was sealed with direct placement of a Jomed covered stent followed by aggressive post dilatation. In addition, a side branch was jailed when the covered stent was placed.
  • Echocardiography showed presence of a small pericardial effusion without tamponade physiology.
  • Troponin-I peaked at 19.4 ng/mL and CK-MB peaked at 82.3 ng/mL.
  • Patient was discharged home 2 days later without any sequelae.

Learning Objectives

  • What is the likely explanation or reason why the complication occurred?
    • Placement of a stent in a calcified segment.
  • How could the complication have been prevented?
    • Plaque modification techniques using an atherectomy device would have helped with better lesion preparation which might have allowed easier expansion of the stent at a lower inflation pressure. Rotational atherectomy was planned for but deferred given the wire passed into the sub-intimal space.
  • Is there an alternate strategy that could have been used to manage the complication?
    • Ellis Type 1 and 2 perforations usually seal spontaneously and are conservatively managed. Such patients should be closely monitored in the catheterization lab, and serial echocardiography should be performed, particularly if there is an Ellis Type 2 coronary perforation because it may lead to cardiac tamponade. Ellis Type 3 perforations are associated with increased risk of cardiac tamponade and mortality, and require immediate intervention/treatment. Ellis Type 3 Cavity Spilling perforation management is unclear. Usually they are conservatively managed, unless there is significant extravasation or the patient is symptomatic.
    • Coronary perforation management algorithm:
      • 1st: Prolonged balloon inflation: Position the balloon (or stent-balloon post stent deployment) just proximal or at the level of the perforation to prevent ongoing extravasation and development of hemo-pericardium. Ideally, the balloon to artery ratio should be 1:1. Inflate for 5-10 minutes followed by test deflations with contrast given in between inflations to evaluate the status of the perforation. If there is ongoing extravasation, re-inflate the balloon to stop further extravasation of blood into the pericardial space. This strategy helps stabilize the patients and gain control of the situation, while the operator prepares for echocardiography, pericardiocentesis, and more definitive treatment to seal the perforation.
      • 2nd: Anticoagulation management: ‘STOP’ all anticoagulation immediately if you suspect or visualize a perforation. We consider ‘REVERSING’ heparin with protamine sulfate (to achieve ACT <225s) after coronary equipment is removed to prevent thrombosis within the vessel. If using bivalirudin, it can take up to 1-2 hours for its anticoagulation effect to a normalize after it is stopped. If patient was on glycoprotein IIB/IIIA inhibitors: For abciximab, consider giving platelet transfusion; tirofiban and eptifibatide have a short half life and their reversal can typically be achieved by stopping there infusion or in extreme cases with hemodialysis. Cangrelor has a short half life and its reversal can be achieved by stopping its infusion.
      • 3rd: Covered stent: Standard of care for a perforation located in the proximal to mid segment of a vessel of appropriate size (≥2.5 mm), with no major side branch across the region where the stent will be placed. If a covered stent can be delivered to a distal vessel perforation, and the vessel is of appropriate size, covered stent placement to seal the perforation is reasonable. If the clinical situation allows, proceed with direct stent placement whenever possible using a single catheter or two-catheter (Ping-Pong) strategy. The stent should be quickly positioned and immediately deployed to high pressure. This should be followed by high pressure post-dilatation (18-20 atm) to achieve appropriate stent apposition.
      • 4th: Embolization of distal vessel perforations: Non-surgical techniques for distal vessel embolization include: Coils, Gel Foams, Glues, Microspheres, Thrombin injection, Subcutaneous tissue, Autologous Blood Clots and multiple other agents (depending on what is available in an individual catheterization lab). Embolization leads to loss of vessel flow beyond point where embolized material is delivered and subsequent infarct in the vessel territory.
      • 5th: Surgery Intervention: Ligation or suturing of the vessel for hemostasis with bypass grafting to the distal vessel. Pericardial patch/Teflon with possible bypass grafting to the distal vessel (consider this approach if vessel has multiple stents and/or presence of a subepicardial hematoma).
  • What are the important learning points?
    • Techniques associated with perforations: use of hydrophilic/extra stiff wires, atherectomy devices, cutting balloons, increase balloon-to-artery ratio, high pressure post-dilatation of stent.
    • Angiographic findings associated with perforations: CTO, severe calcification, type C lesions, eccentric lesions, RCA or LCx lesion, tortuous vessels.
    • Device related perforations tend to be more catastrophic than wire related perforations. This is because devices cause trauma and disrupt the integrity of the vessel wall.
    • After a device (balloon or stent) is inflated inside a coronary vessel, the device should be retracted into the guide and a gentle contrast injection should be performed. If there is a perforation, the device should be immediately positioned in the correct location (just proximal to the perforation or covering the perforation) and inflated to tamponade the vessel. This strategy gives an operator time to obtain equipment to perform more definitive therapy (i.e. covered stent, coils, embolization materials etc.) and prevent hemodynamic decompensation from cardiac tamponade.
    • When there is a type 3 perforation, a stat echocardiogram needs to be performed, consideration needs to be given to stop/reverse anticoagulation and to perform a pericardiocentesis. If immediately available, quickly deliver a balloon just proximal or at the level of the perforation and inflate it to tamponade the vessel (gives you time to plan for more definitive therapy). In the presence of hemodynamic instability or large perforation, you should consider using the Ping-Pong technique to deliver a covered stent.
    • Delivery of a covered stent:
      • A covered stent can be delivered using the same guide catheter after removal and retrieval of the balloon, if there is no significant hemodynamic decompromise and in the absence of a large perforation present. If using this strategy, an operator needs to act quickly because once the balloon is deflated, there will be ongoing coronary extravasation into the pericardial space.
      • Alternatively, a second guide catheter strategy can be used for delivering a covered stent. To do this, obtain alternate access, advance a second guide catheter, disengage the first guide catheter and intubate the perforated artery with the new guide catheter (PING-PONG technique). Next, advance a second guidewire to the proximal edge of the inflated balloon, deflate the balloon, advance the wire to the distal vessel and then immediately re-inflate the balloon. The covered stent is advanced over the second guidewire until proximal to the inflated balloon. Then deflate the balloon and remove it along with the first guidewire (into the initial guide catheter), and quickly position the covered stent and immediately deploy it to high pressure. This should be followed by high pressure post-dilatation (18-20 atm) to achieve appropriate stent apposition.
Educational Content

CORONARY PERFORATION

  • Coronary perforation although rare is one of the most feared complication of percutaneous coronary intervention (PCI)1
  • Incidence: 0.4%2
  • Risk factors:3
    • Chronic total occlusions
    • Angulated calcified type B2 and type C lesions
    • Long lesions (>10 mm)
    • Eccentric lesions
    • Smaller vessel size
    • Older age
    • Female sex
    • Renal failure
    • Previous coronary artery bypass graft surgery
  • Common causes:3
    • Oversizing of the dilatation catheter and balloon/stent mismatch [Balloon - artery ratio >1.3/1]
    • Inflation of a non-compliant balloon to very high pressures
    • Use of atheroablatives devices or cutting balloons
    • IVUS directed optimal PCI with high pressure stenting
  • Classification of coronary perforation: There are two classification schemes for coronary perforation - Ellis4 and Kini classification.5 Ellis classification scheme, more commonly used describes wire and device perforations into following categories:
Type IExtraluminal Crater without extravasation
Type IIPericardial or myocardial blush without a ≥1mm exit hole and without contrast jet extravasation
Type IIIFrank extravasation of contrast and a ≥1mm exit hole
Type III- Cavitary Spilling (CS)Perforation into an anatomic cavity chamber, such as
the coronary sinus, or the right ventricle

Kini classification scheme is more simplistic, focused on wire perforations and describes two types of wire perforations:

  • Type I described as "myocardial stain" with no frank dye extravasation and
  • Type II as "myocardial fan" with dye extravasation into pericardium, coronary sinus, or cardiac chambers
  • A significant proportion of perforations occur with guidewires crossing the lesion, with distal wire perforation or wire fracture. Extra stiff wires and low friction hydrophilic-coated wires are associated with higher incidence of perforation.6,7 This may reflect either use of specialty wires to facilitate passage through more complex lesions or their ease of distal migration.
  • Prevention: meticulous attention to guidewire position, careful and appropriate sizing of the balloon or stent prior to inflation, and avoiding over dilation or high pressure inflation exceeding the balloon's burst pressure
  • Management: Clinical suspicion should rise if patient develops sudden onset of acute/sharp chest pain or have sudden explained severe hypotension, particularly when inflating balloon or deploying a stent. If clinical suspicion arises, pull balloon immediately into the guide and perform angiography to confirm diagnosis.
    • The first aim is to prevent cardiac tamponade by immediate balloon inflation [SDS or the balloon present in the guide] proximal or at site of perforation at the lowest pressure possible. Usually 2-4 atmospheres for about 5-10 minutes is sufficient. However, may need to go to higher pressure and or longer duration to achieve hemostasis. Assess for hemostasis throughout intervention by injecting contrast at regular intervals.
    • Consider anticoagulation reversal: Decision to reverse needs to be balanced against potential risk of acute thrombosis, especially if a stent was just deployed. Heparin reversal: protamine sulfate 1mg IV/100 units of UFH (to achieve activated clotting time of <150s). Bivalirudin reversal: fresh frozen plasma is preferred and it results in partial reversal.
    • Aggressive treatment with intravenous fluids, atropine, vasopressors, mechanical circulatory support may be required if hemodynamics deteriorate. Call CT surgery for backup.
    • Emergent bedside echocardiogram should be obtained. If patient has significant effusion with tamponade physiology, perform emergent pericardiocentesis.

Treatment of coronary perforation

Type 1 perforation
  • Often resolves without intervention and reversal of anticoagulation
  • If above measure fails, perform prolonged balloon inflation (10-15 min) proximal or at site of injury
  • If still persists, follow steps for type II/III/III CS perforations as explained below

Type II/III/III CS perforation
  • Prolonged balloon Inflation proximal or over perforation site and reversal of anticoagulation. If still bleeding, repeat prolonged balloon inflation
  • If extravasation persists, seal the site with either occlusive coils [perforation site distal main vessel] or by implantation of polytetrafluoroethylene (PFTE) covered stent [perforation site proximal main vessel, distal side branch which can be excluded with covered stent]
  • If extravasation still persists or site of injury is proximal main vessel with bifurcation (covered stent not an option) consider emergent surgery
  • Type III CS draining in to coronary sinus or right ventricle is usually benign and can be managed conservatively

Step by step guide for management of coronary wire perforation5
  1. Reverse anticoagulation.
  2. Inflate appropriately sized balloon to low atmospheric pressure proximal or at the site of perforation and confirm sealing of further extravasation with contrast injection from guiding catheter.
  3. Perform prolonged balloon inflation (10–20 min) proximal or at the site of perforation if the perforation is in distal territory or in tertiary branches.
  4. Deflate balloon and perform contrast injection- if persistent extravasation, reinflate balloon and start preparing for coil delivery microcatheter placement.
  5. Remove the balloon and track the coil delivery microcatheter over the guide wire and place it about 1 mm proximal to the site of perforation.
  6. Load the occlusive coil into the microcatheter and advance it by pushing with either a 0.018” guidewire or the stiffer backend of workhorse guidewire. Push the coil out distally and withdraw the catheter simultaneously.
  7. Consider delivery of second coil if there is persistent leak.
  8. In some cases with persistent coronary leak from a side branch, a covered stent can be placed in the main vessel, cutting off the blood supply to the side branch with resultant resolution or minimization of leakage.
  9. Perform transthoracic echocardiogram on procedure table to rule out large pericardial effusion and perform emergent pericardiocentesis if evidence of tamponade.
  10. Monitor in the coronary care unit and obtain an echocardiogram the following day.
  11. Withhold antiplatelet agents for 12–24 hours and resume usual dose once uneventful.



References

  1. Shimony A, Joseph L, Mottillo S, Eisenberg MJ. Coronary artery perforation during percutaneous coronary intervention: a systematic review and meta-analysis. Can J Cardiol 2011;27:843–50.
  2. Kinnaird T, Kwok CS, Kontopantelis E, et al. Incidence, determinants and outcomes of coronary perforation during percutaneous coronary intervention in the United Kingdom between 2006 and 2013. An analysis of 527121 cases from the British Cardiovascular Intervention Society Database. Circ Cardiovasc Interv 2016;9:e003449.
  3. Ellis SG, Roubin GS, Kinh SB, et al. Angiographic and clinical predictors of acute closure after native vessel coronary angioplasty. Circulation 1988;77:372–9.
  4. Ellis S.G., Ajluni S., Arnold A.Z., et al. (1994) Increased coronary perforation in the new device era. Incidence, classification, management, and outcome. Circulation 90:2725–2730.
  5. Kini AS, Rafael OC, Sarkar K, et al. Changing outcomes and treatment strategies for wire induced coronary perforations in the era of bivalirudin use. Catheter Cardiovasc Interv. 2009;74(5):700‐707. doi:10.1002/ccd.22112.
  6. Al-Lamee R., Ielasi A., Latib A., et al. (2011) Incidence, predictors, management, immediate and long-term outcomes following grade III coronary perforations. J Am Coll Cardiol 4:87–95.
  7. De Marco F., Balcells J., Lefèvre T., Routledge H., Louvard Y., Morice M.C. (2008) Delayed and recurrent cardiac tamponade following distal coronary perforation of hydrophilic guidewires during coronary intervention. J Invasive Cardiol 20:E150–E153.