COMPLICATIONS OF PCI PROCEDURE PART 1

DR MOHD IQBAL DAR SKIMS SOURA J&K

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

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

CONTRAST INDUCED NEPHROPATHY

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.

TYPES OF CONTRAST

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

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)

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.

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.

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).

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)

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

ALLERGIC REACTIONS

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

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

Protamine:

Occasionally in diabetic patients using NPH insulin

Rapid injection can also provoke back pain of unknown etiology

Rarely used now a days

CORONARY COMPLICATIONS

CORONARY PERFORATION THREATNED OR ACUTE CLOSURE

Coronary Artery Perforation

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.

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

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

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

• 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

• 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)

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%.

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

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.

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

Predisposing factors

Lesion characteristics

• Calcification • Tortuosity • Eccentric plaque • AHA/ACC class B or C lesions • Small calibre vessel

• 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.

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.

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.

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.

Bivalirudin

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.

ATHERECTOMY

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.

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.

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.

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.

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.

TREATMENT

• 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

Strategy

Strategy depends upon – • Site of the perforation • Severity of the insult • Hemodynamic stability of patient • Persistent bleeding

Supportive measures

• Intravenous fluids • Oxygen • Analgesia • Inotropic support • Atropine • Intra aortic balloon counterpulsation

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.

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.

• 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.

• 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.

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.

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

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.

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.

Pericardiocentesis

• Analgesia • Removal of full volume • Blood products transfusion • Auto transfusion • Goal should be to dry out the pericardial cavity

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%.

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

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.

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.

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

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.

• 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

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.

Surgical outcomes

• The results are disappointing. • The mortality of emergency surgery in reports

of both Fejka and Witzke was 50%.

Sowhy is an operation such a poor option for these

cases

Because…. These are cases with • Other treatment options failed • Ongoing bleeding • Hemodynamic compromise • On inotropic support • Coagulopathy • Myocardial infarction • Deterioration of renal function

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.

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.

Special measures

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

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.

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.).

Balloon occlusion types • Persistent Complete Occlusion • Persistent Partial Occlusion • Intermittent Complete Occlusion • Intermittent Partial Occlusion

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

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

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.

Intermittent Partial Occlusion

• intermittant cycles of partial occlussion • Some success in a few case reports

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

THANK YOU…