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China Interventional Therapeutics (CIT) 2008<br />

March 20 -- 23, 2008<br />

Beijing, China<br />

<strong>“Cath</strong> <strong>Lab</strong> <strong>Catastrophes</strong>:<br />

<strong>Management</strong> <strong>and</strong> <strong>Prevention”</strong><br />

Fayaz Shawl, M.D., F.A.C.C.<br />

Clinical Professor of Medicine<br />

Director of Interventional Cardiovascular Medicine<br />

George Washington University - Washington, D.C.<br />

Director Interventional Cardiology<br />

Washington Adventist Hospital - Takoma Park, Maryl<strong>and</strong>


Faculty Disclosure<br />

Fayaz Shawl, M.D., F.A.C.C.<br />

Research/Grant Support:<br />

Cordis Corporation


Defensive Angioplasty<br />

Knowledge of clinical <strong>and</strong> morphologic factors<br />

relating to mortality <strong>and</strong> complications<br />

Do not overextend your capability<br />

Knowledge of complications relating to different<br />

devices<br />

Plan offensive strategy to h<strong>and</strong>le various anatomic<br />

subsets, plan defensive strategy if failure occurs<br />

Anticipate failure<br />

Review each complication (may prevent the next!)<br />

Record <strong>and</strong> monitor your results, review at frequent<br />

intervals


THE MORTAL RISK OF<br />

INTERVENTION IS MORE<br />

CLOSELY ASSOCIATED WITH<br />

COMPLEX PATIENTS<br />

THAN WITH<br />

COMPLEX LESIONS


Complications of of Percutaneous Intervention: Elective Stenting<br />

Mortality<br />

20<br />

15<br />

10<br />

5<br />

0<br />

Risk Factors<br />

1. EF < 40<br />

Multivariate Correlates of In-Hospital Mortality<br />

2. Creatinine > 1.5<br />

3. Age > 70<br />

4. Triple Vessel Disease<br />

5. Unstable Angina<br />

0.35 0.16 0.52<br />

4.82<br />

3.57<br />

0 1 2 3 4 5<br />

No. of Risk Factors<br />

17.39<br />

N N = = 283 641 574 311 84 84 23 23<br />

(Number of of vessels dilated & & lesion morphology not significant)


Mayo Clinic Risk Risk Score Variables: Predictors of of<br />

Death, Q Q Wave MI, MI, Emergent or or Urgent CABG, CVA CVA<br />

Clinical Variables<br />

Age<br />

Cardiogenic shock<br />

S. creatinine > 265 µml/l (>3.5 mg/dl) or<br />

history of chronic or end stage renal disease<br />

Urgent or emergent procedure<br />

NYHA > 3 heart failure<br />

Angiographic Variables<br />

Thrombus<br />

Left main disease<br />

Multi-vessel disease<br />

Developed from learning set of 5,463 procedures, January 1996-December 1999.<br />

Validated in 1,781 procedures in 2000. Validated in 3,264 pts in NHLBI Dynamic Registry.<br />

Singh M. et al. JACC 2002;40:387-93<br />

Singh M. et al. JACC 2003;42:722-8


Major Complication Rate (%)<br />

25<br />

20<br />

15<br />

10<br />

5<br />

0<br />

Risk:<br />

Risk Score:<br />

Mayo Clinic Risk Risk Score for for PCI PCI<br />

≤ 2<br />

Very Low<br />

0-5<br />

2-5<br />

Low<br />

6-8<br />

5-10<br />

Moderate<br />

9-11<br />

10-15<br />

High<br />

12-15<br />

JACC 2002;40:387<br />

≥ 25<br />

Very High<br />

>15<br />

Risk Factor:<br />

Age 90-99: 6<br />

Shock: 5<br />

Left main: 5<br />

Age 80-89: 5<br />

Age 70-79: 4<br />

Renal disease: 3<br />

Age 60-69: 3<br />

Non-elective<br />

procedure: 2<br />

MV Disease: 2<br />

NHYA > 3: 2<br />

Thrombus: 2<br />

Age 50-59: 2<br />

Age 40-49: 1


Lower Pre-Procedural Hemoglobin Level is Associated<br />

with Increased Risk of In-Hospital Mortality<br />

26,313 consecutive PCI, 9 hospitals, University of Michigan<br />

Hgb Level<br />

6.6-12.3<br />

12.3-13.5<br />

13.5-14.4<br />

14.4-15.4<br />

15.4-20.1<br />

All PCI Patients<br />

N = 24,554<br />

2.9%*<br />

1.6%<br />

1.1%<br />

0.9%<br />

1.1%<br />

Mortality, In-Hospital<br />

S. Beinart et al. Circ 2002;19:3700<br />

PCI with AMI (


Cath Cath <strong>Lab</strong> <strong>Lab</strong> Complications<br />

Prophylactic use of IABP <strong>and</strong> Integrilin


Cath Cath <strong>Lab</strong> <strong>Lab</strong> Complications


Cath Cath <strong>Lab</strong> <strong>Lab</strong> Complications<br />

Result


Cath Cath <strong>Lab</strong> <strong>Lab</strong> Complications


Cath Cath <strong>Lab</strong> <strong>Lab</strong> Complications<br />

Error of Omission - Post IVUS Evaluation


Coronary Dissection Following PCI PCI<br />

Causes<br />

Guide Catheter:<br />

L Amplatz Guide<br />

# 6 Fr. JR4 Guide!!<br />

Balloon/Stent Oversizing<br />

Overexpansion<br />

particularly on angle ><br />

45°<br />

Calcified Vessel<br />

Chronic Total Occlusion


Edge Edge Dissection Following Stenting<br />

Non-flowing limiting. Arc of dissection <<br />

90°<br />

STRUT Trial<br />

Incidence 17%; no in-hospital complications<br />

Hong, et al. - 327 pts<br />

Incidence 20.4%; no in-hospital complications<br />

6-month TLR 23.9 vs 22.3%<br />

SHERIS Trial - 150 pts<br />

Incidence 10.7%; 6-month TLR 25% vs 27%<br />

All tears healed by IVUS


Cath Cath <strong>Lab</strong> <strong>Lab</strong> Complications


Cath Cath <strong>Lab</strong> <strong>Lab</strong> Complications<br />

Recurrent Chest pain 6 hrs. post-PCI


Dissections Following Elective Coronary Stent<br />

Placement: Acute <strong>and</strong> <strong>and</strong> Long-Term Outcomes<br />

No<br />

Dissection<br />

Dissection<br />

A-B<br />

Dissection<br />

C-F<br />

No. 1426 101 52<br />

Pvalue<br />

30 Day: Death (%) 0 0 2 0.11<br />

Q AMI (%) 1 0 4 0.03<br />

Non Q AMI (%) 5 4 13 0.007<br />

9 Month: Death (%) 1 2 2 0.18<br />

Q AMI (%) 1 1 4 0.01<br />

Non Q AMI (%) 5 4 15 0.005<br />

TLR (%) 10 8 19 NS<br />

J. Saucedo et al. Circ 2000;102:1155


Stent Thrombosis<br />

<strong>Management</strong><br />

Mechanical opening of stent<br />

<strong>Management</strong> of thrombus<br />

IIbIIIa inhibitor<br />

Angiojet<br />

X-SIZER (Endicor)<br />

Aspiration Thrombectomy<br />

Identify the Cause<br />

IVUS evaluation<br />

Check medications


Coronary Perforation<br />

Perforation Classification<br />

TYPE I: Extraluminal crater without<br />

extravasation<br />

Type II: Pericardial or myocardial blush<br />

without contrast jet extravasation<br />

Type III: Extravasation through frank (> 1<br />

mm) perforation<br />

Type III (Cavity Spilling): Perforation into<br />

anatomic cavity (e.g. Coronary Sinus)<br />

S.G. Ellis et al. Circ 1994;90:2725-30


Coronary Perforation<br />

Clinical Outcome 62/2900 Procedures<br />

(0.5%)<br />

Death Em-CABG Q-AMI Tamponade<br />

Type N (%) (%) (%) (%)<br />

I 13 0 15 0 8<br />

II 31 0 10 0 13<br />

III CS 2 0 0 0 0<br />

III 16 19 63 15 63<br />

S.G. Ellis et al. Circ 1994;90:2725-30


Cath Cath <strong>Lab</strong> <strong>Lab</strong> Complications<br />

Chronic<br />

Total<br />

Occlusion


Coronary Perforations:<br />

Incidence, Predictors <strong>and</strong> <strong>and</strong> Outcome<br />

5728 pts; 10,000 lesions; 4/93-11/01 Milan Italy<br />

Incidence 84 pts (1.5%)<br />

POBA 45 (53.6%)<br />

DCA 8 (9.5%)<br />

Rota 3 (3.6%)<br />

Cutting balloon 2 (2.4%)<br />

Guidewire 23 (27.4%)<br />

Other devices 3 (3.6%)<br />

Atheroablative procedure 2.4% vs. 1.3%<br />

Complex lesions 1.9% vs. 0.5%<br />

Higher B/A ratio 1.3 vs. 1.2<br />

G. Stankovic et al. Circ 2002;19:2210


Coronary Perforations:<br />

Incidence, Predictors <strong>and</strong> <strong>and</strong> Outcome (cont.)<br />

5728 pts; 10,000 lesions; 4/93-11/01 Milan Italy<br />

Outcomes<br />

In-hospital In-hospital MACE 34.5%<br />

AMI 17.8%<br />

Em-CABG 13.1%<br />

Death 8.3%<br />

G. Stankovic et al. Circ 2002;19:2210


Vessel Perforation: <strong>Management</strong><br />

Don’t panic<br />

Prolonged balloon inflation<br />

Reverse heparin<br />

Platelet infusion, FFP<br />

Echocardiogram<br />

Pigtail catheter to pericardium<br />

Covered stent (if deliverable)<br />

Gelfoam or thrombus occlusion of vessel<br />

Surgery rarely required<br />

Follow-up echocardiogram very important


Air Embolus<br />

Often from manifold injections<br />

(contrast or flush)<br />

Prevention<br />

Avoid pressurized flush<br />

Back bleed before injecting<br />

Small amounts are well tolerated<br />

Large amounts cause “Air Lock”<br />

Chest Pain<br />

Bradycardia<br />

Hypotension


Air Lock: <strong>Management</strong><br />

Don’t Panic<br />

100% O2<br />

Morphine, Atropine<br />

Neosynephrine 0.1 mg. IV<br />

I/C Epinephrine 1:10,000 dil.<br />

Turn patient<br />

Suction / Flushing<br />

IABP<br />

CPS (for refractory hemodynamic<br />

collapse)


Death<br />

Risks Risks of of PCI PCI<br />

Myocardial infarction<br />

Acute closure<br />

Vascular perforation<br />

Embolus of clot or air or plaque debris<br />

Side branch occlusion<br />

Hematoma <strong>and</strong> Hemorrhage<br />

Others: SAT<br />

Renal failure


Cerebrovascular Complications<br />

Rare (0.07%), mostly embolic in<br />

origin, careful management of<br />

wires, guide catheter, <strong>and</strong> flush<br />

Endocarditis patient: LV thrombus -<br />

avoid LV gram<br />

Majority from plaques on aorta<br />

Check ACT - keep > 250 sec.


Myocardial Infarction<br />

Mechanism Dissection, Abrupt closure,<br />

Side branch closure, No<br />

reflow, Thrombosis, Distal<br />

embolism<br />

Recent trials Q-wave at 1 - 2%<br />

Non-Q MI 5 - 10%<br />

CPK/MB 1 - 3x elevation: little<br />

consequences<br />

> 5x elevation: adverse<br />

long term effects


Acute Closure<br />

Abrupt closure: 2 - 9% (TIMI 0-II<br />

Flow)<br />

Threatened closure: Dissection or<br />

Thrombus with TIMI III Flow<br />

Prevention:<br />

Antiplatelets<br />

IIb/IIIa inhibitors<br />

Treat thrombus before stenting


Factors Associated with with Abrupt Abrupt Closure<br />

Clinical: unstable angina, female,<br />

AMI, chronic renal failure<br />

Angiographic: Intraluminal thrombus,<br />

long lesion, > 45 degree<br />

angulation, branch points,<br />

proximal tortuosity, ostial<br />

RCA, SVG, prestenosis ><br />

90%, intimal dissection


Predictors of of Mortality after after Abrupt Abrupt<br />

Closure<br />

% myocardium at risk<br />

LM & MV disease<br />

CHF, UA<br />

Target vessel supplies collaterals<br />

Age > 65<br />

Chronic Renal Failure<br />

Female gender<br />

Diabetes


Stent vs. Conventional Techniques for the Treatment of<br />

Abrupt Vessel Closure or Symptomatic Dissections<br />

100 pts with abrupt vessel closure / symptomatic<br />

dissection<br />

R<strong>and</strong>omized to Stent (n = 51) vs. Prolonged<br />

dilation/Emergency CABG<br />

In-Hospital<br />

Events<br />

Stent<br />

(n = 51)<br />

St<strong>and</strong>ard<br />

(n=49)<br />

Death 2% 2%<br />

QMI 16% 8%<br />

Emerg CABG 4% 0


Think: dissection, embolus, air,<br />

hypotension as well as microemboli<br />

High risk with SVG, Thrombus, Rota,<br />

Diffuse disease<br />

Prevent: ?IIbIIIa, CA ++ Prevent: ?IIbIIIa, CA antagonists,<br />

++ antagonists,<br />

Adenosine, DPD<br />

Slow Slow or or No No Flow<br />

Flow<br />

Treat: Support B/P with pressors, IABP<br />

Administer: distal Nitroprusside,<br />

Adenosine, CA ++ Administer: distal Nitroprusside,<br />

Adenosine, CA antagonists, Epinephrine<br />

++ antagonists, Epinephrine


Coronary Perforation<br />

PTCA 0.1%, Roto/DCA 0.5 - 2.0%. Stent<br />

0.5%<br />

Wire perforation (3/7000) rare, but may be<br />

slow to be recognized. Often with stiff wire,<br />

hydrophilic wire<br />

If device doesn’t follow, usually benign<br />

Device perforation can be rapidly fatal<br />

May occur hours later<br />

Clinical signs are variable<br />

Treatment: reverse A/C, perfusion balloon,<br />

centesis, covered stents, coils, RH Cath,<br />

serial ECHOs


Perforation Risk Risk<br />

Wire - Vessel Tortuosity (Esp.<br />

Hydrophilic Wire Use)<br />

Ablative Techniques - With Vessel<br />

Tortuosity<br />

Stents - Small Calcified Vessels / High<br />

B/A Ratio<br />

Interaction with IIbIIIa inhibitors<br />

???


Coronary Perforation in in the the Era Era of of Abciximab<br />

36 perforations<br />

6,214 PCI (0.58%)<br />

73.7<br />

Abciximab use<br />

57.1<br />

21.2<br />

Portamine<br />

64.3<br />

15.8<br />

Platelet TX<br />

50<br />

erfusion balloon<br />

26<br />

85.7<br />

5.3<br />

Tamponade<br />

42.9<br />

5.3<br />

Pericardiocentesis<br />

E Dippel et al., CCI 2001<br />

Perforation class by Ellis et al.<br />

50<br />

0<br />

Urgent CABG<br />

Class II<br />

Class III<br />

50<br />

Death<br />

21.4<br />

0


Coronary Perforation in in the the Era Era of of Abciximab<br />

N = 6,999 consecutive PCI from 1994 thru 1996<br />

Overall tamponade incidence 0.2% (15 pts)<br />

Perforation Causes:<br />

Target Lesion Site (n=5)<br />

Tip of Guidewire (n=3)<br />

Temporary Pacemaker Wire (n=7)<br />

0.3<br />

2.3<br />

3.2<br />

10.8<br />

PTC Stent DC/TEC ROTA<br />

Incidence by device<br />

Von Sohsten et al, Am Heart J 2000<br />

# per 1000 pts


Subacute Stent Thrombosis<br />

Increased risk with small vessels, multiple<br />

stents, uncovered dissection, low EF<br />

DES: multiple stents, long stents, small<br />

vessels, risk even higher - up to 1 year<br />

after stopping antiplatelets<br />

Risk for Q-wave MI: 60%<br />

Mortality: up to 25%


Allergic Reactions<br />

Local anesthetic (rare), contrast, protamine<br />

Anaphalactoid (no IgE)<br />

Increased risk with atopic disorder, seafood (?),<br />

prior contrast reaction<br />

Prevent: Prednisone (13 hrs+), H1 <strong>and</strong> H2<br />

blockers, Premedications<br />

Treat: One ml of Epi 1:10:000 in 10 ml, give 1 ml<br />

every minute, steroids,<br />

volume, volume, volume<br />

Protamine (cross reaction with NPH insulin)<br />

give test dose


Hypotension<br />

Think Think of hypovolemia (bleed <strong>and</strong><br />

dehydration), tamponade (esp.<br />

with TTVP)<br />

Vasovagal Vasovagal reaction, anaphylaxis,<br />

occlusion<br />

Treat Treat per diagnosis


Retroperitoneal Hematoma<br />

Uncontrolled free bleeding usually means<br />

laceration of the artery: change sheath,<br />

remove sheath <strong>and</strong> compress<br />

Puncture above the inguinal ligament may<br />

lead to retroperitoneal hematoma<br />

(Puncture using Fluoro)<br />

Rx: CT scan, transfusion, occasional surgical<br />

decompression, reverse IIbIIIa & heparin


Pseudoaneurysm <strong>and</strong> <strong>and</strong> AV AV Fistula Fistula<br />

Frequency 1 - 2%<br />

< 2 cm. Usually close spontaneously<br />

90% close with compression<br />

Thrombin injections<br />

Surgery rarely needed<br />

Prevention: Accurate puncture <strong>and</strong> initial<br />

control of the bleeding with sheath upsize<br />

<strong>and</strong> early removal


Iliac Iliac Dissection or or Perforation<br />

Generally occurs during retrograde passing of<br />

wires <strong>and</strong> catheters through tortuous or stenotic<br />

arteries<br />

If these dissections are retrograde <strong>and</strong> small,<br />

usually the forward blood flow will tag down the<br />

dissection flap<br />

If persists or flow limiting, can be treated by<br />

stenting<br />

Perforation: seal with PTA balloon, then operate<br />

or put covered stent


What What are are the the Steps Steps that that can can be be taken taken to to<br />

Minimize Complications?<br />

Ischemia:<br />

Embolism:<br />

Slow Flow:<br />

IABP with LM, Decreased EF<br />

Diffuse calcium with Roto<br />

Embolectomy Catheters<br />

IIbIIIa inhibitors<br />

ADP inhibitors<br />

IIbIIIa inhibitors<br />

Distal Protection<br />

Thrombectomy<br />

Prophylactic Ca ++ Prophylactic Ca blockers, Nipride,<br />

++ blockers, Nipride,<br />

or adenosine preloaded on<br />

delivery catheters


What What are are the the Steps Steps that that can can be be taken taken to to<br />

Minimize Complications Cont...?<br />

Side Branch Occlusion:<br />

Perforations:<br />

Renal Failure:<br />

Debulking<br />

Dual Stents<br />

Avoid Stenting<br />

Coils<br />

Covered Stents<br />

Contrast agents<br />

Small guides<br />

Hydration <strong>and</strong> diuresis


Preprocedural Risk Risk Assessment<br />

Conceptual Framework<br />

Should I Perform the Procedure?<br />

Absolute<br />

1. Risk to the Patient<br />

Rate of Death or MACE per 100<br />

Rate of “Minor” Complications<br />

Long Term Risk of Death, MI, & TLR


Preprocedural Risk Risk Assessment<br />

2. Risk to the Patient -<br />

Relative Risk<br />

Risk of PTCA vs. Alternative Therapies<br />

(Surgery or Medical Rx) for Short <strong>and</strong><br />

Long Term Complications


Preprocedural Risk Risk Assessment<br />

3. Risk to the Operator<br />

Adverse Outcomes on Physician<br />

Profile for Hospital Privileges, Payor<br />

Contracts, <strong>and</strong> Public Relations


What What are are Procedural Complications?<br />

Ischemia<br />

Acute Closure<br />

Embolism<br />

Side Branch Occlusion<br />

Slow / No Flow<br />

Perforation<br />

Other<br />

SAT<br />

Renal Failure


What What are are Procedural Complications?<br />

Wire Crossing<br />

Thrombosis<br />

Severe/Angulated Stenosis<br />

Poor Visualization<br />

After Wire Crossing<br />

Dissection, thrombus, major stroke,<br />

branch closure<br />

Can we deliver a stent?<br />

Calcium<br />

Tortuosity<br />

Poor guide support<br />

}Potential Potential for getting<br />

caught with your<br />

pants down! (i.e.<br />

closure without<br />

distal protection)


Correlates of of Adverse Outcomes<br />

Old<br />

Small / large<br />

USA<br />

Female<br />

Low LVEF<br />

SVG<br />

Thrombus<br />

Clinical<br />

CHF<br />

Angiographic<br />

Emergency<br />

PVD<br />

RF<br />

Calcification<br />

Bifurcation<br />

Tortuosity


Summary<br />

Intra-procedural complications can be prevented<br />

<strong>and</strong> minimized (but not eliminated) with today’s<br />

technology <strong>and</strong> careful planning.<br />

Acute <strong>and</strong> long term mortality are determined<br />

primarily by clinical factors not controlled by the<br />

operator.<br />

Consideration of short <strong>and</strong> long term risks to<br />

patients must be assessed taking both these facts<br />

into consideration.<br />

These risks, when compared to therapeutic<br />

alternatives, will lead to optimal outcome for<br />

patients.

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