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.
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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
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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.
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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.
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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.
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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.
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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:
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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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