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Perforation Type 2 Device – Case 1

Clinical Presentation

  • 82-year-old male who presented with chest pain (CCS Class III).

Past Medical History

  • HTN, HLD, Former Tobacco Use, Asthma
  • LVEF unknown

Clinical Variables

  • ETT: Abnormal. High risk.
  • Prior Cardiac Catheterization: LAD FFR = 0.75.

Medications Heading

  • Home Medications: Rosuvastatin, Amlodipine, Valsartan, HCTZ, Potassium Chloride
  • Adjunct Pharmacotherapy: Clopidogrel, Bivalirudin

Pre-procedure EKG Heading

Angiograms

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Left coronary artery angiography
  • 60-70% severely calcified bifurcation lesion in the mid left anterior descending (LAD) coronary artery
  • 60-70% stenosis in the second diagonal branch (D2).
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Left coronary artery angiography

  • 60-70% severely calcified bifurcation lesion in the mid left anterior descending (LAD) coronary artery
  • 60-70% stenosis in the second diagonal branch (D2).
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Right coronary artery (RCA) angiography

  • no significant disease in the RCA.
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Rotational atherectomy of the LAD using a 1.75mm burr at 150k RPM.

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Angiography of the D2 branch after lesion pre-dilatation with a Trek NC 2.5/15mm balloon (14 atm) showing a type 2 perforation.

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Angiography after prolong balloon inflation to tamponade the vessel showing unsuccessful sealing of the perforation.

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Angiography of the LAD after placement of a Jomed 3.0/12mm covered stent showing successful sealing of the perforation with procedure now complicated by a distal stent edge dissection.

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Balloon inflation to treat the dissection and post-dilatation of the stent in D2 with a Trek NC 2.5/15mm balloon.

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Angiography of the LAD after post-dilatation of the stent and treatment of the distal stent dissection showing inadequate treatment of the dissection.

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Positioning of a Xience Alpine 2.25/15mm stent in the D2 branch overlapping with the with the previous stent distal edge.

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Angiography of the D2 branch after a second stent was placed showing successful sealing of the perforation and treatment of the dissection with loss of a small side branch off the D2.

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Pre-dilatation of LAD with a NC Quantum Apex 3.0/15mm balloon.

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Deployment of a Xience Alpine 3.5/18mm stent in the LAD.

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Follow up angiography of the LAD after stent post dilatation with a Trek NC 3.5/12mm balloon.

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Final angiography of the LAD-D2 after placement of multiple stents showing successful intervention.

Post-procedure EKG

Post-procedure Echocardiography

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Case Overview

  • Underwent complex intervention of the LAD-D2 bifurcation.
  • Pre-dilatation of the lesion in D2 resulted in a type 2 perforation.
  • Perforation was inadequately sealed with prolonged balloon tamponade of the vessel.
  • A covered stent was deployed with procedure being further complicated by a distal stent edge dissection. This was successfully treated with placement of another stent followed by post-dilatation of the stent.
  • Procedure was continued and patient underwent successful LAD-D2 bifurcation stenting.
  • Echocardiography showed presence of a small pericardial effusion without tamponade physiology.
  • Troponin-I peaked at 12.07 ng/mL and CK-MB peaked at 67.8 ng/mL.
  • Patient was discharged within 72 hours in stable condition.

Learning Objectives

  • What is the likely explanation or reason why the complication occurred?
    • High pressure (pre)dilatation of a calcified vessel.
  • How could the complication have been prevented?
    • Lesions preparation with atherectomy with cutting balloon angioplasty prior to performing lesion pre-dilatation could have helped reduce calcified plaque burden, and made it safer to prep the vessel and reduce the chance of complications.
    • Avoid aggressive, high pressure, over sized balloon dilatation of a calcified lesion as this can result in complications.
  • 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.
    • When a complication occurs, an operator needs to quickly recognize and assess the situation to see if treatment of the complication should take precedence.
      • In this case, intervention was deferred, anticoagulation stopped, and the perforation/dissection was treated immediately. The procedure was continued and successful intervention was performed. Failure to treat the perforation before continuing with the planned intervention could have lead to the development of cardiac tamponade.
      • One of the management strategies in treating coronary perforation involves stopping anticoagulation therapy. If a stent is placed prior to treatment of a perforation, the reversal of anticoagulation could lead to a catastrophic event such as acute stent thrombosis.
    • An operator must always remain vigilant for the presence of multiple complications. In this case, treatment of the perforation with a covered stent resulted in a Type C distal stent edge dissection which required additional treatment with a drug eluting stent.
    • Type 1 perforation is similar to a type C dissection, and often difficult to distinguish from one another. Nonetheless, both can be managed with placement of a stent.
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.

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