starting an extraction program getting your ducks in a row…
DESCRIPTION
Starting an Extraction Program Getting your ducks in a row…. Samir Saba, MD, FHRS Director, Cardiac Electrophysiology University of Pittsburgh Medical Center. Disclosures. Research Grants Medtronic Inc. Boston Scientific Inc. St. Jude Medical Inc. Consultant St. Jude Medical Inc. - PowerPoint PPT PresentationTRANSCRIPT
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Starting an Extraction Program
Getting your ducks in a row…
Samir Saba, MD, FHRS
Director, Cardiac Electrophysiology
University of Pittsburgh Medical Center
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Disclosures
• Research Grants• Medtronic Inc.• Boston Scientific Inc.• St. Jude Medical Inc.
• Consultant• St. Jude Medical Inc.• Spectranetics Inc.
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Who are the ducks?
1. Physician
2. Staff
3. Equipment
4. Support
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The First ‘Doc’
• Experience in all aspects of lead implantations and extractions
– Typically a high volume CIED implanter
– Knowledge of indications
– Familiarity with all technical aspects of extractions
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Operator’s Experience• Complete procedural success improves
dramatically – after first 10–20 procedures1
• Lower complication rates with ≥30 cases – Continue to decline with up to 400 cases2
• Medicare ICD database review: – Decreased mechanical complications with ≥10
implantations per year – Reduced infections with ≥30 implants per year year3
1 Bracke FA. Learning curve characteristics of pacing lead extraction with a laser sheath. PACE 1998; 21: 2309– 2313. 2 Ghosh N, Yee R, Klein G, Krahn A. Laser Lead Extraction: Is there a learning curve . Pace, 2005; Vol 28 180-184. 3 Al-Khatib SM. The relation between patients' outcomes and the volume of cardioverter-defibrillator implantation procedures
performed by physicians tr treating Medicare beneficiaries. J Am Coll Cardiol 2005;46:1536–40
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Operator’s Experience
“Given the relationship demonstrated between lead extraction experience and safety and efficacy; and since these techniques are much more technically demanding and are associated with a much larger opportunity for failure and complications, it was the consensus of the writing group that a volume of extraction procedures, similar to those required for device implantation, should be required.”
HRS/ACC/AHA Expert Consensus. Heart Rhythm. 2009;6:1085-1104.
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Minimum Training Volume• Physicians being trained in this technique should
extract a minimum of 40 leads as the primary operator under the direct supervision of a qualified training physician.
• Recommend the extraction of a minimum of 20 leads annually per operator.
• Physicians who have already extracted over 40 leads as a primary operator and maintain the minimum volume of 20 leads extracted annually are considered as meeting the training and volume requirements.
• The trainer of physicians learning lead extraction should have extracted 75 leads.
• All should be performed with an efficacy and safety record that is consistent with published data.
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Volume vs. Proficiency• The number of procedures does not guarantee
proficiency• A quality-oriented database should be maintained at
each institution• Given the learning curve for this procedure, it is
recommended that as a physician and a center’s experience grows, so can the degree of difficulty of the cases increase.
• There is a community of lead extractors who are available for ongoing mentoring. When beginning a new program, a mentor or mentors should be identified.
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Other Team Members: Supporting Staff
1. EP Lab or OR scrub Nurse (with primary operator)
2. Nurse anesthetist familiar with procedure
3. Circulating (‘non-scrub’) nurses (at least 2)
4. Fluoroscopy tech for troubleshooting
5. Echocardiography tech for emergent echo
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Other Support
1. Anesthesiologist
2. CT surgeon
3. Echocardiographer
4. Blood Bank
5. Administration
Readiness for emergent open-heart surgery
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Equipment
1. Good quality fluoroscopy2. Anesthesia machine3. Echo machine (TTE and TEE)4. Surgical tools5. Extraction tools
– Mechanical and powered sheaths
6. Groin station (all kinds of snares and other tools)
7. CIED Implantation equipment
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Tools for Chronic Lead Extraction
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Need for other tools
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Off-Label Use of Tools to Retrieve Lead Fragments
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Other Challenges
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Other Challenges
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Other Challenges
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And Still Other Challenges…
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Other ducks to consider…Teaching and Training
• Teaching and educating:– Physicians in the community – Cardiologists caring for patients with CIED– Patients
• Training of new explanters– Hands-on cases– Simulators– Observation
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Beyond Lead Extraction: Lead Management
• When we implant a patient we are assuming responsibility for his/her well-being for future implantations to come
• Lead survival is very dependent on implantation techniques
• Fidelis failure ranging from 1% to 20+%• Complications at the time of lead extraction
are function of choices made at the time of lead implantation.
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Beyond Lead Extraction: Lead Management
• Device Choice: Single vs. dual vs. triple chamber• Lead choice:
– Single vs. dual coil ICD lead– Active vs. passive fixation
• Site of implantation: – right vs. Left– High incision or Low incision
• Vein of choice: cephalic vs. axillary vs. subclavian• Decisions at implantation :
– Remove superfluous leads– Do not cut and retract superfluous leads– Avoid tunneling– No excessive flushing
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Recap
1. Team approach– Primary operator, nurses, techs– CT surgery, Anesthesia support– Imaging support: Echo and Fluoro– Hospital support: Administration and blood
bank
2. Spectrum of Tools
3. Spectrum of Techniques
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Final Words of Wisdom
• Start a Lead Management Program not just and extraction program
• Do not start with extremely difficult cases – Refer very difficult cases early on– Build experience and confidence before you
tackle more difficult cases• Ask for advise
– Pick up the phone and call• Plan, train, and practice for emergencies• Track your own performance (Registry with
outcomes)
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Questions?