2. There has been dramatic expansion in the use of
PCI to treat coronary artery disease in last three
decades
6 lac PCI procedures performed yearly in USA and
20 lac world wide
PCI expected to grow @ 5% yearly
Major contributors are advances in equipment
design and deliverability and development of
adjunctive pharmacological strategies
3. PCI is relatively a safe procedure in a well equipped
catheterization lab with a very low complication rate
Complication if occur are usually very serious
Knowledge of recognition and management of
complications vital for favorable outcome
7. Contrast induced nephropathy(CIN) Is a generally
reversible form of acute kidney injury(AKI) that
occurs soon after the administration of radio
contrast media.
After intravascular CM injection, immediate renal
toxicity may occur,and in most cases it remains
fortunately free of significant clinical consequences.
Sandler CM. Contrast-agent-induced acute renal dysfunction –is
iodixanolthe answer? N EnglJ Med. 2003;348(6):551–3.
13. A decreased incidence of contrast nephropathy
appears to be associated with nonionic agents,
which, are either low osmolal (500to850mosmol/kg)
or iso-osmolal (approximately290mosmol/kg).
Iodixanol, the only currently available iso-osmolal
nonionic contrast agent
(approximately290mosmol/kg), may be associated
with a lower risk of nephropathy than some low-
osmolal agents, particularly iohexol
14. To assess the cumulative risk of several variables on renal
function,a simple CIN risk score that could be readily applied
was developed.(MEHRAN RISK SCORE)
15. PREVENTION OF CIN
General consideration
Consider alternate Imaging studies not requiring
iodinated contrast medium.
The use of lower doses of low-or iso-osmolal non
ionic contrast agents and avoidance of repetitive
studies that are closely spaced
(within48to72hours).
Avoidance of volume depletion.
16. Concomitant nephrotoxic drugs such as NSAID and
nephrotoxic antibiotics, ACEI and diuretics should
be discontinued 48 hours prior to contrast
administration.
Metformin should be discontinued on the day of the
proposed CM administration and for the
subsequent 48hours.
17.
18. HYDRATION
Isotonic saline is superior to one-half isotonic saline
since isotonic saline is a more effective volume
expander.
In a study by Mueller et al, intravenous
administration of isotonic saline was found to be
superior, compared with half-isotonic saline, in
reducing the rates of CIN after percutaneous
coronary intervention (0.7%versus2%,respectively).
19. Hydration with Saline
IVF= 1 mL/kg/hr (MAX 100 ml/hr) 3 hours pre & 12
hours post contrast
CHF or left ventricular ejection fraction (LVEF) <
40% 0.5 ml/kg/hr(max 50 ml/hr) 3 hrs pre& post
contrast
Emergent procedure? (suggested regimen):
Fluid bolus of 3ml/Kg prior to procedure. Hydration
during procedure and/or 12 hrs after if possible
(dependent on clinical status)
20. Bicarbonate Dosing
IVF= 150 meqof sodium bicarbonate in 850 ml of
D5W 3 ml/kg bolus (MAX 300 ml) 1 hour prior to
procedure and 1 mL/kg/hour (MAX 100 ml/hr)
during and for 6 hours post-procedure.
Glycemic control issues (including patients with
diabetes) Consider mixing sodium bicarbonate in 1
liter of sterile water instead of D5W
22. Can be precipitated by
Local anesthetic
Contrast agent
Protamine sulfate
Local anesthetic:
In patients with previous reaction-
Use preservative free agents e.g., bupivicane,
mepivicaine
23. Contrast Allergy
Upto 1% of patients
Risk is highest in patients with prior history of reaction
Risk is also in patients with asthma, atopy, history of sea
food allergy (contain iodine)
Prevention
Risk reduced by premedication with steroids, H1 blocker
and H2 blocker
Use of non-ionic dye
Treatment
If anaphylactic reaction then use epinephrine 1:10,000
(1ml = 0.1mg) admistered I/V every minute until pulse
restored
I/V Fluids infused rapidly as overall fluid status warrents
Consider vasopressors if hypotension do not responds
I/V Hydrocortisone
If bradycardia consider Atropine
24. Protamine:
Occasionally in diabetic patients using NPH insulin
Rapid injection can also provoke back pain of unknown
etiology
Rarely used now a days
28. Coronary Perforation
Coronary artery perforation is defined as
evidence of extravasation of contrast medium
or blood from the coronary artery, during or
following percutaneous intervention.
29. Anatomically, perforation is categorized as –
• Proximal or mid vessel
Usually more profound with greater likelihood
of significant sequelae
• Distal vessel
There the aetiology is often the guide wire
(WIRE EXIT) and the clinical course is
frequently benign
30.
31.
32. Other classifications
Fukutomi
Type I: Epicardial staining without a contrast
extravasation
Type II: Epicardial staining with a visible jet of contrast
extravasation
Kini2
Type I: Myocardial staining without contrast
extravasation
Type II: Contrast extravasation into pericardium,
coronary sinus, or cardiac chambers
33. First data…
• Ellis and colleagues reported first large scale series derived
from data obtained from 11 centres, from 1990 and 1991.
• Of 12,900 procedures performed, 62 were complicated by
coronary perforation (0.5%). •
• They observed that the use of ‘new devices’ increased risk of
perforation
34. • Only 14 out of 62 perforations (23%) occurred
following POBA, others from debulking techniques.
• Complication rate –
POBA - 0.1%
Excimer laser - 1.9%
Rotational atherectomy - 1.3%
• Predesposing patient characteristics –
Female gender
Increasing age
35. • Over sizing of the angioplasty balloon was one of the
key causes for perforation.
• The development of cardiac temponade was
associated with appreciable mortality (20%)
particularly if it occurred in catheter laboratory as a
result of brisk extravasation (Type III)
36. Incidence and outcomes
• The incidence of Coronary Artery Perforation
(CAP) has not changed significantly over two
decades.
• It is reported between 0.2% and 0.9%.
37.
38. Sequelae of CAP
• Caused by CAP
Blood loss
Distal ischemia
Pericardial Temponade
Cardiogenic shock
Death
• Caused by management strategies
Myocardial Ischemia
Acute vessel occlusion
Myocardial infarction
Operative morbidity and mortality
Death
39. Diagnosis
• Not all perforations are immediately visible on coronary
angiography.
• Remarkable proportion of patients may develop temponade
more than 2 to 6 hours after procedure. •
• The clinical manifestation may be non-specific, and the
patient may simply develop progressive hypotension.
• A high index of suspicion should be maintained in order to
secure the correct diagnosis in a timely fashion.
40. Outcomes
• In various studies, outcomes depend largely upon the severity of
perforation.
• The outcome is worse if the temponade develops abruptly within the
catheter laboratory, rather than in the delayed fashion in the recovery
room or ICU.
• Outcomes also depend upon associated co-morbidities.
Chronic renal dysfunction
Pre-procedural impairment of LV function
Older patient
• Cavitary spilling type III perforation – may cause coronary steel in long
term
43. • A study1 of 38559 patients with 72 perforations reported that
more than 40% of perforations were seen in vessels of less
than 2.5mm diameter.
• The authors describe that the device-lumen mismatch is more
important than the vessel reference diameter.
• Other study2 of 8932 patients with 35 perforations showed
that balloon induced perforation was more likely where the
balloon to artery ratio was 1.3±0.3 compared with a ratio of
1.0±0.3 where no problem ensued.
1.Javaid A, Buch AN, Satler LF, et al. Management and
outcomes of coronary artery perforation during percutaneous coronary intervention. Am J Cardiol 2006;98:911-4. 2.Ajluni S,
Glazier S, Blankenship L, et al: Perforations after percutaneous coronary interventions: clinical, angiographic, and therapeutic
observations. Catheter Cardiovasc Diagn 32:206– 212, 1994.
44. Use of GP IIb-IIIa inhibitors
• Studies comparing outcomes of CAP in patients with or
without use of GPI reported a modest adverse influence
where GPI were used.
• In a study* of 16,298 patients with 95 perforations, GPI
were used in 33 cases.
• When these 33 cases were compared with the other 62
cases (where GPI were not used), they found no difference
in
• Mortality and
• Myocardial Infarction
But, GPI use was associated with
• Higher incidence of temponade and
• Greater requirement of emergency surgery
*Fasseas P, Orford JL, Panetta CJ, et al. Incidence, correlates, management, and clinical outcome of coronary perforation: analysis of 16,298 procedures. Am Heart J
2004;147:140-5.
45. GPI and perforations
• Great caution should be exercised if any perforation is
identified, even if seemingly trivial, where GPI is used.
• Abciximab binds irreversibly to platelet receptors, rendering
platelet activity almost negligible for 24 – 36 hours.
• In case of perforation with Abciximab, unlike the small
molecules Tirofiban and Eptifibatide, simply discontinuing the
infusion of Abciximab will not reverse its effect.
• Platelet transfusion may be required to restore bleeding time.
• The strategy should be case based, balancing the stoppage of
life threatening haemorrhage with the importance of
maintaining crucial revascularization in a given case.
46.
47. BIVALIRUDIN
• This study compared the consequences of CAP in patients who
underwent anticoagulation with bivalirudin to those in patients
who underwent anticoagulation with heparin at time of CP.
• From 33,613 procedures, 69 patients (0.2%) had CAP, Bivalirudin was
used in 41 patients, while Heparin in 28.
• The primary end point for this analysis was the composite of in-
hospital death, cardiac tamponade, or emergency cardiac surgery.
• The primary composite end point was similar between groups.
• However, there was a lower rate of cardiac surgery requirement in
BIV- treated patients.
• The study suggests that choice of procedural anticoagulant agent
does not influence outcome when CP occurs.
49. BIVALIRUDIN
• A pooled analysis of patients treated with PCI in three randomized trials
including REPLACE-2, ACUITY, and HORIZONS-AMI.
• Among a total of 12,921 patients, CAP occurred in 35 patients (0.27%).
• Baseline creatinine clearance was the only independent predictor of CA
perforation.
• Patients assigned to BIVALIRUDIN versus UFH plus a GPI had
• non significantly lower rates of death,
• similar rates of MI,
• significantly lower rates of TVR, and
• similar rates of the composite end-point of death/MI/TVR.
• In three PCI trials, treatment of patients experiencing CA perforation with
bivalirudin monotherapy was not associated with worse outcomes
compared to treatment with UFH plus GP IIb/IIIa inhibitors.
51. Atherectomy
• Use of either atherectomy or laser ablative technology is associated
with a higher incidence of perforation than in convention balloon and
stent PCI.
• However, the increased complication rate using these devices is strongly
influenced by the complexity of the coronary disease being treated.
• Ellis1 and colleagues reported that the incidence of perforation with
balloon angioplasty was 14 out of 9080 cases (0.1%), whereas that of
debulking techniques collectively was 48 out of 3820 cases (1.3%).
• Later reports suggested CAP rate of 0.4% for rotablation.
1.Ellis SG, Ajluni S, Arnold AZ, et al. Increased coronary perforation in the new device era: incidence, classification, management, and outcome. Circulation
1994;90:2725-30. 2.Gruberg L, Pinnow E, Flood R, et al. Incidence, management, and outcome of coronary artery perforation during percutaneous coronary
intervention. Am J Cardiol 2000;86:680-2, A8. 3.Fejka M, Dixon SR, Safian RD, et al. Diagnosis, management, and clinical outcome of cardiac tamponade complicating
percutaneous coronary intervention. Am J Cardiol 2002;90:1183-6.
52. Guide Wires
• Several authors have clearly pin-pointed the
hydrophilic wire as a more risky equipment for
perforation.
• Javaid et al1 found that 13 out of 15 wire associated
perforations had hydrophilic coating.
• Ramana el2 at found that the majority of 25
perforations were caused by guide wires and these
were usually hydrophilic and stiff.
• Witzke3 and group found that 51% of perforations were
wire mediated
1.Javaid A, Buch AN, Satler LF, et al. Management and outcomes of coronary artery perforation during percutaneous coronary intervention. Am J
Cardiol 2006;98:911-4. 2.Ramana RK, Arab D, Joyal D, et al. Coronary artery perforation during percutaneous coronary intervention: incidence and
outcomes in the new interventional era. J Invasive Cardiol 2005;17:603-5. 3.Witzke CF, Martin-Herrero F, Clarke SC, Pomerantzev E, Palacios IF. The
changing pattern of coronary perforation during percutaneous coronary intervention in the new device era. J Invasive Cardiol 2004;16:257- 301.
53. Guide Wires
• Wires are much less likely to cause a breach in the
proximal or mid vessel, but more likely to do so distally,
in the terminal sub branches.
• They are also less likely to cause frank rupture of the
vessel than a high pressure balloon barotrauma.
• Hence, the appearance of angiography is more subtle
when the wire is the culprit.
• Fasseas classified 86% of guide wire mediated ruptures
as Ellis type I or II on angiography.
Fasseas P, Orford JL, Panetta CJ, et al. Incidence, correlates, management, and clinical outcome of coronary perforation: analysis of
16,298 procedures. Am Heart J 2004;147:140-5.
54. Guide Wires
• A proportion of such patients may go on to
develop pericardial temponade.
• In some instances this only becomes manifest late
(between 2-24 hours post procedure)
• One way to minimize distal trauma is to create
loop at the end of the wire, rendering it less likely
to inadvertently puncture the vessel wall.
• The adjunctive use of GPI may potentiate
prolonged bleeding from a seemingly minor
blemish in the vessel.
55. Chronic Total Occlusions
• In CTO intervention, there is always a high risk of coronary
perforation, and more so with the heavy weight, stiff tipped wire.
• If there is no balloon inflation where the wire is incorrectly
positioned, there is minimal extravasation of contrast and blood.
• Use of GPI should be withheld until the occlusion is safely crossed
and the operator is confident that the distal tip of the wire is seated
intraluminally.
• Shimony* and colleagues studied 9568 procedures and compared 57
patients having CAP with 171 patients who had no CAP and found
that CTO intervention is the strongest independent predictor of
CAP, followed by calcified lesions and NSTEMI.
*Shimony A, Zahger D, Van Straten M, et al. Incidence, risk factors, management and outcomes of coronary artery perforation
during percutaneous coronary intervention. Am J Cardiol 2009;104:1674-7.
57. • Most important step is to recognize and
identify presence of a perforation.
High index of suspicion
• Subtle signs:
Unusual migration of wire tip
dye staining
unexplained hypotension
58. Strategy
Strategy depends upon –
• Site of the perforation
• Severity of the insult
• Hemodynamic stability of patient
• Persistent bleeding
59. Supportive measures
• Intravenous fluids
• Oxygen
• Analgesia
• Inotropic support
• Atropine
• Intra aortic balloon counterpulsation
60. Type I perforations
It usually respond to conservative measures.
• In any case, indispensable measures are:
Fastidious post-procedural care
Cautious monitoring of hemodynamic parameters
At least one, and if required, serial echocardiographic
assessment.
Javaid A, Buch AN, Satler LF, et al. Management and outcomes of coronary artery perforation during percutaneous
coronary intervention. Am J Cardiol 2006;98:911-4.
61. Type II or III perforations
• Initial management is similar.
• First objective is to stop bleeding.
• Immediate step is to inflate a balloon at the site of
bleeding if it is in the mid or proximal vessel, and
more distally for a remotely situated wire
perforation to buy the time for further strategy
making.
• This prevents the development of temponade,
and favourably alters the outlook of the situation.
62. • In significant proportion of cases, prolonged
balloon dilatation is all that is required.
• Balloon inflation for upto 30 min is required.
• If the patient can not tolerate ischemia, then
perfusion balloon, if available may be helpful.
• Fukotomi reported excellent results using
perfusion balloon for Ellis type III rupture
Fukutomi T, Suzuki T, Popma JJ, et al. Early and late clinical outcomes following coronary perforation in patients undergoing percutaneous
coronary intervention. Circ J 2002;66:349– 356.
63. • A number of authors advocated deployment
of standard intracoronary stents to secure
perforation site.
• This may involve the deployment of a number
of layers of stent over the point of rupture
before it can be sealed off.
64. Anticoagulant therapy and platelet
inhibitors
Important question –
Whether dealing with the perforation signals the
end of the procedure or the operator wants to
continue the procedure after control of bleeding
is achieved.
• If the case is to be discontinued, reversal of the
heparin with protamine has been shown to be
effective alongside other measures.
• But this should be deferred till balloons and wires
are still in the artery.
65. GPI
• Intravenous GPI should be discontinued in
majority of cases where perforation is identified.
• Even seemingly trivial blush of extravasation may
progress to severe problems if these agents are
ongoing.
• Abciximab counteraction with fresh platelets
transfusion, as earlier discussed, should be
executed with precaution on case by case base
66. ACT
• There is no clear recommendation regarding
which level of the heparin anticoagulant effect
should be maintained after CAP.
• Because intervention devices remain in the
patient, the heparin effect should not be
completely reversed, and it might be acceptable
to maintain the ACT at 150–250 s.
• The ACT should be measured immediately after
CAP.
• Further treatment is dependent on the bleeding
level and hemodynamic status.
67. Cardiac Temponade
• Immediate Echocardiography, urgent drainage by
pericardiocentesis is must.
• Drainage not only alleviates hemodynamic problem, but
also allows for an active evaluation of the rate of
ongoing bleeding from the perforation site.
• Sometimes, accumulation of very small amount of
pericardial blood may result in profound hemodynamic
suppression or cardiac arrest.
• Deploying a drain in such situation is very difficult.
• At least a clear rim of fluid should be visible on
echocardiography before putting a drain, otherwise
there is a risk of puncturing RV free wall.
69. Pericardiocentesis
• Once the space is completely dry, the volume
which is further accumulated should be
counted every minute to know the success of
local treatment at perforation site.
• If there is no resolution of bleeding at 30
minute, further action is required.
• This may include Surgery.
• Pericardial temponade in this situation carries
mortality of 20-50%.
70. Covered Stents
• Frank rupture of proximal or mid coronary
artery often constitute a tear in the vessel,
upto 5 mm in length.
• Deploying a covered stent isolates the point of
haemorrhage from the circulation.
• The most widely used device is PTFE covered
stent.
• Sandwich design
• Inflexible, difficult to deliver in certain areas
71. Covered Stents
• Briguori1 and colleagues reported 11 cases treated in this fashion
and compared them with other 17 cases treated with BMS.
• In both groups, balloon temponade and reversal of anticoagulation
failed.
• MACE rate was 18% in covered stent group compared to 88% in BMS
group.
• Stankovic2 reported reduction in MACE rate for TYPE III perforations
using PTFE covered stents but no benefit was gained in type II
perforations.
1.Briguori C, Nishida T, Anzuini A, Di Mario C, Grube E, Colombo A. Emergency polytetrafluoroethylene-covered stent implantation to treat coronary
ruptures. Circulation 2000;102:3028 –3031. 2. Stankovic G, Orlic D, Corvaja N, Airoldi F, Chieffo A, Spanos V, Montorfano M, Carlino M, Finci L,
Sangiorgi G, Colombo A. Incidence, predictors, in- hospital, and late outcomes of coronary artery perforations. Am J Cardiol 2004;93:213–216.
72. Covered Stents
• On the other side, Ly and colleagues achieved successful seal of the
perforation using PTFE in 71% of cases, but there was no statistically
significant reduction in the development of temponade, nor the
requirement of emergency surgery when it was compared to prolonged
balloon dilatation.
• Difficulty in delivery of this inflexible device is most troublesome in the
calcified, tortuous vessel which is usual substrate in the perforated vessel.
73. Covered Stents
• Additional late concern is of in-stent restenosis.
• Although poorly quantified, a small number of
patients undergoing angiographic follow-up showed
29% restenosis rate.
Briguori C, Nishida T, Anzuini A, Di Mario C, Grube E, Colombo A. Emergency polytetrafluoroethylene-covered stent implantation to
treat coronary ruptures. Circulation 2000;102:3028 –3031
74. Distal Perforation
• Covered stents are of no benefit.
• Most of them are caused by angioplasty guide
wire.
• Objective is to seal off the leaking branch.
• Little concern for ischemia to the small region
of myocardium supplied by it.
75. • If conventional measures fail, vessel may be
occluded by –
• Platinum microcoils (Trufill – Terumo)
• Injection of Thrombin
• Autologous clotted blood
• Subcutaneous adipose tissue
• Tris-Acryl gelatin microspheres
• Polyvinyl alcohol foam
76. Emergency Surgery
• Cases not responding to conventional
measures are sent for emergency surgery.
• These perforations are frank ruptures, and not
modest distal perforations.
• Ellis reports 63% of type III perforations had to
go for surgery, while very few of type I or type
II underwent surgery.
77. Surgical outcomes
• The results are disappointing.
• The mortality of emergency surgery in reports
of both Fejka and Witzke was 50%.
So
why is an operation such a poor option for these
cases
78. Because….
These are cases with
• Other treatment options failed
• Ongoing bleeding
• Hemodynamic compromise
• On inotropic support
• Coagulopathy
• Myocardial infarction
• Deterioration of renal function
79. Other views
No surgery…
• Some operators send remarkably few patients for an operation, and their
overall mortality figures are impressively low.
• Fukutomi1 and colleagues reported 69 cases of CAP, 29 progressing to
temponade.
• The mortality was zero.
• Only two of the 69 underwent surgery.
• Therefore, conservative or percutaneous treatment options may be
successful in vast majority of patients too.
1.Fukutomi T, Suzuki T, Popma JJ, et al. Early and late clinical outcomes following coronary perforation in patients
undergoing percutaneous coronary intervention. Circ J 2002;66:349– 356.
80. Surgery
when….
• it is always sensible to keep surgical team
ready to take patient on operative table at any
moment.
• If the bleeding from pericardial tube is
persisting at a rate above 10mL per minute
despite all other action being taken,
mechanical and pharmacological, it is prudent
to call a surgeon.
83. Special measures
A case report of LAD CTO intervention complicated by
Type III perforation with Conquest pro wire over
Finecross Microcatheter.
• Immediate removal of wire and applying negative
pressure of 2-3 mmHg for 3-5 minutes through
microcatheter while preparing the fat emboli
sealed the perforation successfully. TCTAP C-031,
Case from Indonesia
84.
85. Dual guiding catheter technique
• Retrieving the balloon and inserting a covered
stent may require some time and it is possible
that the stent will not reach or cross the lesion.
• Hence, the perforation may be without sealing
for an unpredictably long period of time.
• Use of a dual guiding catheter approach reduces
the duration of uncontrolled hemorrhage through
the perforation.
86. Dual guiding catheter technique
• After placing a second guiding catheter and guide wire,
the covered stent can be advanced and placed
immediately proximal to the sealing balloon.
• In a rapid maneuver, the sealing balloon can be
retracted and the covered stent advanced and
implanted.
• If initial delivery of the covered stent fails, re-insertion
of the blocking balloon can be performed quickly which
provides time to consider options for a second attempt
(smaller covered stent, additional guide wire, upsizing
the guiding catheter, etc.).
89. Persistent Complete Occlusion
• Balloon inflated to completely occlude the
artery
• Usually not more than 20 min, max 30 min
• Good results WITH 60-70% SUCCESS RATE
• Drawback-Heparin can not be reversed with
protamine at the perforation place
90. Persistent Partial Occlusion
• Controlled Hypotension
MAP 55-65, in Hypertensives <30% of baseline
• Partial Occlusion causes stenosis of the vessel
with drop in pressure and TIMI flow distal to
occlusion casuing decreased rate of bleed and
facilitating sealing of perforation
• Short length, highly compliant balloon
inflation at the location of CAP
91. Intermittent Complete Occlusion
• An intermittent, nonfatal complete ischemic model is found to
improve tissue tolerability to reperfusion injury after long-term
ischemia and to delay cell death.
• This is known to induce “ischemic preconditioning (IPC)”
• A 10 min ischemia/1 min reperfusion model is optimal. • If
necessary, this procedure can be repeated three or four times.
• Notably, IPC can attenuate ischemia reperfusion injury during cardiac
surgery, which is the ultimate method to treat CAP.
• However, this model may not be satisfactory for patients with
preexisting cardiac dysfunction.
• To avoid cardiac function deterioration, a shortened ischemic time or
prolonged reperfusion time (such as 5 min/5 min) model should be
an alternative in these patients.
93. Conclusion
• It is favourable that CAP remains a rare complication.
• High index of suspicion.
• Immediate diagnosis and localization of perforation
• Urgent and serial echocardiographic monitoring
• “Stop the bleeding” first
• Prolonged balloon dilatation always
• May need covered stent
• Quick Pericardiocentesis
• Worse outcomes if emergency surgery is warranted