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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
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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
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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
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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
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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