ASDIN 9th Annual Scientific Meeting

1

Stenting Over Transvenous CIED Leads

is Acceptable for Central Venous

Stenosis in Selected PatientsTheodore F. Saad, M.D.

Christiana Care Health SystemNephrology Associates, PA

Newark, DE

Relevant Disclosures &

Conflicts of InterestTheodore F. Saad, M.D.

• Consultant

– Bard, Peripheral Vascular

– WL Gore

• Clinical Investigator

– Bard, Peripheral Vascular

• No financial interests

2

Stents for Treatment of

Central Vein Stenosis

• Little evidence to support use over

conventional PTA

• Guidelines (KDOQI) support use in cases of

angioplasty failure

• Not the issue in question here

3

Figure 9.6 (Volume 2)

Period prevalent ESRD patients4

Unfortunate Reality: Hemodialysis Patients

Receiving ICD Therapy Don’t Do WellSurvival Following Implantation of ICDs: 1999–2008

USRDS 2010 Annual Data Report

Figure 47-25_Survival rates for gastric cancer patients

undergoing gastrectomy as stratified by combined

American Joint Committee on Cancer (AJCC), 5th ed.

5

Stents or Stent-Grafts for

CRMD-Associated Central Vein StenosisSaad TF, Myers GR, Cicone JS: J Vasc Access 2010; 11: 293-302

• Retrospective review over 60 months

• 16 central venous stents or stent grafts placed in 14

patients with AV access & ipsilateral CRMD

– Placed for “failed angioplasty”

• Recurrent stenosis (< 3 months)

• Recoil post-PTA

– Mean age 72.6 years

– 10 with AV fistula; 4 with PTFE graft; None with catheter

6

ASDIN 9th Annual Scientific Meeting

2

7

Stents or Stent-Grafts for CRMD Associated

Central Vein Stenosis

• 100% technical success

– No procedure-related complications

• No device malfunction: Early or late

• No device lead infection or endocarditis

– One patient with MSSA sepsis at 3.7 years; resolved with

antibiotic therapy

• 7 deaths; 35.3% annual mortality– 6 withdrew from dialysis

– 1 withdrew from mechanical vent after respiratory failure

– None related to CRMD failure or sepsis

8Saad TF, Myers GR, Cicone JS: Journal of Vascular Access 2010

Stents or Stent-Grafts for CRMD

Associated Central Vein Stenosis:

Post-Intervention Patency

Saad TF, Myers GR, Cicone JS: Journal of Vascular Access 2010

Days

Patency (%)

Mean 2.1 repeat interventions

per year to maintain patency

9

“..it is inappropriate to stent open a vein, trapping the pacing

leads against the vein wall and preventing future safe lead

extraction110, 113, 114, 115

“Lead removal is recommended in patients with planned stent

deployment in a vein already containing a transvenous lead to

avoid entrapment (Level of Evidence Class C)”

10

Heart Rhythm 2009; 6: 1085-1104

Published Evidence in Support

of HRS Guideline:

• NONE

• Unpublished anecdotes & theorization

– Complicated infections with entrapped leads

– Difficult, more invasive, or higher morbidity

procedures required for lead removal?

• We don’t know what was done

– Poor outcomes?

• We don’t know what happened

11

“Entrapment of transvenous CIED leads by stent

placement should be avoided. When stenting is

deemed necessary, it is preferable to first

extract CIED leads and replace them via an

alternative transvenous or epicardial route.”12

ASDIN 9th Annual Scientific Meeting

3

Changes in Our Practice 2009-2013

• Only two patients have been treated with stents over

CIED leads

– Hesitancy

• AHA-HRS guidelines & ASDIN position paper

– Lessened use of ICD as primary prevention in ESRD

– Better planning by EP & vascular surgeons

• Avoid creating ipsilateral access/CIED.

• We just don't run into this problem as often

– Judicious use of CIED lead extraction

– Favoring new contralateral access instead of stenting to

preserve ipsilateral access

• We've done this now for several patients

13

Percent of ESRD patients receiving ICDs/CRT-DsUSRDS 1010 Annual Data Report

Figure 9.3 (Volume 2)

Period prevalent ESRD patients.

14

What Has Happened to our

Study Cohort? Mortality

• Three of the original 14

patients remain alive

– One had access failure due

to pseudoaneurysms 32

months after stenting

– Two remain on dialysis

with ipsilateral AV access

• One original

• One revised, same side

15

Clinical Study of Laser Lead

Extraction: US Total ExperienceByrd et al., PACE 2002; 25:804-808

• Large multi-center study

• 1684 patients

• 2561 CRMD lead extraction procedures

– 90% success; 3% partial success

– 7% failure

– “Learning curve:” Better results with higher case volume

• Major complications 1.9%

– Tamponade, hemothorax, pulmonary embolism, lead migration

– Death in 13/1684 patients (0.8%)16

Lead Extraction in the

Contemporary Setting:

The LExiCon Study

• 2004-2007

• 1449 patients

• 96.5% successful laser lead extraction

• “Major adverse events” 1.4%

– 4 Death (0.28%)

• Greatest risk associated with endocarditis &

creat >2.0 mg/dl): mortality 12.4%17

HRS Guideline for Lead ExtractionWilkoff et al., Heart Rhythm 2009

“Recommendations for lead extraction apply

only to those patients in whom the benefits of

lead removal outweigh the risks when

assessed based on individualized patient

factors and operator specific experience and

outcomes”

18

ASDIN 9th Annual Scientific Meeting

4

CIED Lead Extraction vs. Stenting

Cost/Risk vs. Benefit

Extraction/Replacement

• Early

– Higher cost

– Higher risk

– Morbidity/mortality

• Late

– Lower risk for complex lead

infection

Stenting

• Early

– Lower cost

– Lower risk

– Low morbidity/mortality

• Late

– Higher risk for complex lead

infection

19

Palliative Approach to

Hemodialysis Patient Care

• Age

• Advanced co-morbid

conditions

– Cardiomyopathy

– Vascular Disease

• Nursing home status

• Is there a role for less

invasive, less expensive

solutions?

– Should ICD therapy be

offered to all?

– Should renal-replacement

therapy be initiated or

continued?

– For management of ICD-

related CV stenosis, is there a

role for stenting over leads?

20

Stents for CIED-Lead Associated CV

Stenosis: Conclusion

• High procedure success

• Low complication rate

• Poor primary patency rates

• High secondary patency rates

• Patency similar to those reported for

– CV stents without CRMD

– PTA for CRMD stenosis without stenting

21 22

CIED Position Paper:

Deleted Scenes-I• Stenting over CIED leads should be performed

sparingly in patients with limited life-expectancy

meeting all of the following conditions:

– Venous hypertension is severe with significant

dysfunction of the arteriovenous access or limb

– Repeated PTA has failed to relieve symptoms or is

required at unacceptably frequent intervals

– CIED lead extraction has been attempted

unsuccessfully or is determined to be associated

with excessive risk

23

CIED Position Paper:

Deleted Scenes-II– The patient has a functional arteriovenous access

reasonably expected to last the patient for the

rest of their lifetime on hemodialysis

– There is no existing or anticipated requirement for

long-term venous hemodialysis catheter access

– There is no feasible contralateral AV access option

– There has been consultation & agreement with

the patient’s electrophysiologist to stent

– The patient is fully informed regarding the risks

and consequences of stenting over CIED leads.

24

ASDIN 9th Annual Scientific Meeting

5

25

Management of CIED-Associated

Central Vein Stenosis:

Does One Size Fit All?

No!

26

Options for Management of CRMD-Associated

Central Vein stenosis

PTA-Alone as necessary to control symptoms and maintain access function

– Clearly the preferred approach (Asif, Salman, et al., SID 2009)

When simple PTA fails to achieve acceptable result, options include

1. Ligation of the ipsilateral access

a) Construction of new AV access in the contralateral limb or leg

b) Conversion to peritoneal dialysis

c) Venous catheter access

2. “Banding” of high-flow AV access

3. Surgical bypass to internal jugular vein or contralateral central vein

4. Observation, elevation, compression: “hope” for collateral veins to develop

and relieve venous hypertension

5. Extraction of CIED leads

a) PTA, stenting (as indicated)

b) Replacement of CIED leads through stent or via other route (epicardial, transvenous, SQ)

c) No CIED replacement if indications for device are marginal or have improved/changed

6. Stenting of lesion leaving CRMD leads in place 27