By Craig J. Beavers, PharmD and Jayant Bagai, MD, FSCAI

Procedural complications are an inevitable part of the practice of invasive and interventional cardiology. Fortunately, due to staff diligence and careful attention to case selection and technical aspects, serious complications are rare. However, it is precisely the rarity of their occurrence that makes these “cath lab disasters” so dangerous. A long time interval since the occurrence of a serious complication carries the risk of making the operator and cath lab staff complacent. The lack of preparedness, or even worse, the lack of necessary equipment and knowledge base to deal with them, can rapidly result in serious morbidity or mortality. Everyone in the cath lab knows the trauma of a complication or death in the cath lab. We also know the satisfaction of averting a tragedy by quick recognition and action.

In this Tip Of The Month, we focus on systems processes to mitigate cath lab disasters with the intention of improving the quality of care delivered in these circumstances to potentially save lives.

This tip restricts its focus to complications occurring during diagnostic and interventional coronary procedures. By intention, it does not include structural heart, peripheral or electrophysiological procedures.

Some selected cath lab disasters and staff response are listed in Table 1.
 

Complication Incidence and predisposing conditions Prevention and preparation strategies Staff knowledge base Staff response
Serious coronary perforation (Ellis Class II/III) 0.5% (1 in 200)1,2

Female patients, advanced age, calcified lesions, CTO PCI, cutting balloon, atherectomy, myocardial bridge PCI, over-sized balloon/stent, polymer jacketed wire
Identify availability of covered stents and coils in adequate sizes especially prior to CTO PCI Protamine dose and side effects

Impact of platelet infusion for reversal of GPI effect

Location and sheath compatibility of covered stents and coils
Stop anticoagulation

Call for extra hands

Call for stat ECHO

Notify anesthesia and respiratory for airway support

Notify cardiac surgery (if available on site). For PCI sites without cardiac surgery, notify partner institution and assess transport options.

Identify pericardio-
centesis kit, covered stents, coils, IABP
Severe left main dissection 0.06% diagnostic angiography (~1 in 1700) 0.1% PCI (1 in 1000)3

Non-coaxial engagement of left main, especially with Judkins catheters, Amplatz catheters, guide deep throating during balloon withdrawal, left main disease
Careful deliberate, co-axial engagement of left main

Extra care when using Amplatz catheters, use of “soft tip” Amplatz catheters

Careful monitoring of guide pressure

Never inject with damped pressure
Recognize significance of damped pressure and do not inject if noted

Recognition of contrast staining, NHLBI grades of dissection and their significance
Call for extra hands

Notify cardiac surgery

IABP / Impella / ECMO depending on patient’s hemodynamics

In the presence of reduced flow and hemodynamic instability, percutaneous approaches to restoration of flow should be considered with the use of stents.

Anticipate possible use of GPI
Iatrogenic ascending aortic dissection during coronary angiography or PCI 0.02-0.04% (1 in 2500-5000)4,5

Angiography or PCI during acute MI, RCA PCI, Amplatz guide,  injection of contrast in presence of damped pressure or ostial dissection
Never inject with damped pressure

Use of side hole guide for ostial RCA PCI to decrease hydraulic pressure of injection

Stop injecting additional contrast if aortic cusp stain / dissection noted and stent vessel ostium quickly
Recognize significance of damped pressure and do not inject if noted

Recognition of classes of iatrogenic ascending dissection and their outcomes
Perform aortic root angiography in LAO view to ascertain extent of dissection  - particularly if aortic root and carotid vessels are involved

Call for stat ECHO to r/o pericardial effusion

Pain and BP/HR control

Notify cardiac surgery for Class 2 (extension up ascending aorta < 4 cm) or Class 3 (extension up aorta > 4 cm) dissection
Severe air embolism Use of 4 or 5 F systems, large volume injection from injector  without air detection capability Always aspirate for air bubbles before injecting

Avoid making a “running connection” with a pressurized saline bag

Check for air in the barrel of the injector

Drip saline on catheter hub while withdrawing wire, especially with 4 or 5 F systems.
Identification of air in barrel of injector when preparing for large volume injection

Identification of air in line of manifold or automatic injector

Identification of empty saline bag

Recognition of  “sucking sound” as air is entrained into the catheter
Call for extra hands (if patient arrests)

Start CPR if patient arrests Institute aggressive ACLS as patient can invariably be resuscitated

Administer 100% oxygen

Trendelenburg position to avoid transit to cerebral vessels 

Forceful injection of saline or blood to displace air to distal segment of coronary artery can be attempted6

Identify aspiration catheters to remove intra coronary air

Anticipate need for IABP, transvenous pacemaker
Anaphy-
lactoid shock
Incidence ~ 0.23% (1 in 430) Death- 1 in 55,0007

History of severe contrast allergy
Ask every patient about known history of contrast allergy

Pre-medicate for known or suspected contrast allergy
Recognize signs and symptoms of serious reaction (hives, lip swelling, stridor, hypotension)

Knowledge of dose and  correct dilution of SC and IV epinephrine
Systemic anaphylactoid reactions to iodinated contrast media during cardiac catheterization procedures: guidelines for prevention, diagnosis and management
Cardiac arrest Pre cath lab arrest

Cardiogenic shock

High risk PCI (last remaining vessel)

Severe LV dysfunction
Recognize hemodynamic deterioration and take prompt action to determine its cause and reverse it before arrest

Pre PCI placement of mechanical circulatory support for high risk PCI and/or shock
Recognition of pre arrest scenario (no reflow, narrowing pulse pressure, runs of VT, severe bradycardia)

Set up and role of different MCS devices

Vasopressor and inotrope  effect and dose
Call for extra hands

2 person chest compressions and bag mask ventilation

Call anesthesia and respiratory therapy / code blue

Prepare for defibrillation / pacing

Prepare drugs for ACLS, IC Epinephrine

Notify perfusion and set up ECMO (preferable and if available) or Impella; IABP if ECMO and Impella unavailable

Other serious but less common complications include rupture of the pulmonary artery during right heart catheterization, stent loss, device embolization, entrapped rotablator burr, bioptome, catheter or wire and femoral or retroperitoneal hemorrhage while patient is on the table, serious brady or tachyarrhythmias, unexplained hypotension, respiratory depression/arrest, stroke and pulseless limb during or after intervention.

The following are some of the methods to prepare cath lab staff so that they can manage these complications.

  1. Run mock drills on a quarterly basis to assess staff and lab preparedness to deal with the most serious complications, which have the potential to cause rapid death or serious disability. A list of elements to include in the drills is located in Table V of the SCAI Expert Consensus Statement: 2016 Best Practices in the Cardiac Catheterization Laboratory

  2. The drills should focus on defined roles for cath lab staff, assessing the knowledge base of staff, especially staff that are recent additions or part time. A special “Disaster Cabinet” should be organized with clearly identified location of rarely used equipment such as covered stents, snares, aortic occlusion balloons, pericardiocentesis tray, etc. The cabinet should contain folders with instructions on how to prepare the correct dilution of medications for IV and intra coronary (IC) use and updated contact numbers for anesthesia, respiratory therapy, perfusion, cardiac surgery, ECHO lab and ORs.

  3. Protocols designed to identify patients at increased risk for rare complications as well as for the management of serious complications as agreed on by the cath lab director, operators and staff should be pre-printed in large font, and kept in labeled binders in the marked “Disaster Cabinet”. These issues should be highlighted during the “time out” with specific roles assigned.  

  4. Post-procedure de-briefing in the event of a serious complication or “near-miss” to identify what went wrong. QI techniques including Root Cause analysis, if appropriate, should be used.

  5. All major complications should be reviewed in a morbidity and mortality (M&M) conference. In-lab death, cardiac arrest, stroke, emergency CABG and unanticipated PCI due to iatrogenic etiology must be reviewed.  Deaths must be reviewed within 30 days of occurrence. The M&M should occur at least quarterly and representation from cath lab staff is ideal. The conference is non punitive with the goal of quality improvement.

  6. Comparison of rates of serious complications in your cath lab with national benchmarks, and if a significantly higher rate is noted, to determine the cause(s) and solution(s) by initiating a QI project. A system such as used by the Veterans Affairs catheterization laboratories can be modeled and adapted for local use to improve quality 8.


References:

  1. Hendry C, Fraser D, Eichhofer J, Mamas MA, Fath-Ordoubadi F, El-Omar M, Williams P. Coronary perforation in the drug-eluting stent era: incidence, risk factors, management and outcome: the UK experience. EuroIntervention. 2012 May15;8(1):79-86.
  2. Kiernan TJ, Yan BP, Ruggiero N, Eisenberg JD, Bernal J, Cubeddu RJ, Witzke C, Don C, Cruz-Gonzalez I, Rosenfield K, Pomersantev E, Palacios I. Coronary artery perforations in the contemporary interventional era. J Interv Cardiol. 2009 Aug;22(4):350-3.
  3. Eshtehardi P, Adorjan P, Togni M, Tevaearai H, Vogel R, Seiler C, Meier B, Windecker S, Carrel T, Wenaweser P, Cook S. Iatrogenic left main coronary artery dissection: incidence, classification, management, and long-term follow-up. Am Heart J. 2010 Jun;159(6):1147-53
  4. Dunning DW, Kahn JK, Hawkins ET, O'Neill WW. Iatrogenic coronary artery dissections extending into and involving the aortic root. Catheter Cardiovasc Interv. 2000 Dec;51(4):387-93.
  5. Núñez-Gil IJ, Bautista D, Cerrato E, Salinas P, Varbella F, Omedè P, Ugo F,Ielasi A, Giammaria M, Moreno R, Pérez-Vizcayno MJ, Escaned J, De Agustin JA, Feltes G, Macaya C, Fernández-Ortiz A; Registry on Aortic Iatrogenic Dissection (RAID) Investigators. Incidence, Management, and Immediate- and Long-Term Outcomes After Iatrogenic Aortic Dissection During Diagnostic or Interventional Coronary Procedures. Circulation. 2015 Jun 16;131(24):2114-9.
  6. Khan M, Schmidt DH, Bajwa T, Shalev Y. Coronary air embolism: incidence, severity, and suggested approaches to treatment. Cathet Cardiovasc Diagn. 1995 Dec;36(4):313-8.
  7. Goss JE, Chambers CE, Heupler FA Jr. Systemic anaphylactoid reactions to iodinated contrast media during cardiac catheterization procedures: guidelines for prevention, diagnosis, and treatment. Laboratory Performance Standards Committee of the Society for Cardiac Angiography and Interventions. Cathet Cardiovasc Diagn. 1995 Feb;34(2):99-104.
  8. Maddox TM, Plomondon ME, Petrich M, Tsai TT, Gethoffer H, Noonan G, Gillespie B, Box T, Fihn SD, Jesse RL, Rumsfeld JS. A national clinical quality program for Veterans Affairs catheterization laboratories (from the Veterans Affairs clinical assessment, reporting, and tracking program). Am J Cardiol. 2014 Dec 1;114(11):1750-7.

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