pedal access in cli when to use it and how to avoid damage
TRANSCRIPT
Pedal Access in CLIWhen to Use it and How to
Avoid Complications
Fadi Saab MD, FACC,FASE,FSCAI
Associate Director of Cardiovascular Laboratories
Co-Director of Pulmonary Embolism and Deep Venous Thrombosis Services
Clinical Assistant Professor-Michigan State University
School of Medicine
Metro Heart and Vascular
Metro Health Hospital
Disclosures
• Bard Peripheral Vascular - Research, Consultant,
• Cardiovascular Systems, Inc. - Research, Consultant,
• Cook Medical - Research, Consulting
• Covidien – Consulting
• Terumo – Consulting
• Spectranetics – Research, Consulting
Tibio-Pedal Access
• Benefits
• Indication to use
• Contra-indications
• Complication recognition
Advantage of Retrograde Tibial Access
Increase success rate of crossing
Shorten treated segment
Preserve options of therapy : Surgery, atherectomy
Utilize hibernating lumen
Preserve tibial vessels flow
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Tibio-Pedal AccessClinical Consideration
• Critical Limb Ischemia patients• Patients with Long CTO’s• Patients with CTO reconstitution
with the P2/3 segment of the popliteal artery
• Patients with CTO reconstitution within the Tibial vessels
• Patients with hostile groin access (Fibrotic, Obese, Prior surgery)
• Patients unable to lay flat (Back pain, COPD, CHF)
Anatomical Consideration
• Adequate tibial reconstitution (Usually distal third)
• Patients with adequate anterior and posterior communicating circulation
• Patients with distal CTO Caps that are concave in retrograde fashion
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Tibio- Pedal Access
Relative Contra- Indicated
• Claudication with single vessel runoff
• Patients with complete occlusion of tibial vessels.
White stop sign
• Inability to insert a sheath
• Intolerance to anticoagulation or vaso dilators
• Local expertise and staff training
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Chronic Total Occlusion Crossing Approach based on the Plaque Cap Appearance. The C-TOP Trial
• Retrospective analysis evaluating CTO CAP
morphology.
• Interim analysis of patients enrolled in the PRIME
registry with CTO’s
• Prevalence of different CTO caps
• Access selection, technique and success rate of
crossing
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Proposed C-TOP classification
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Advanced CTO Crossing
Requiring Pedal Access
Re-Back Technique
Access Complications
• Not Common
• Pattern Recognition
• Institutional Quality measures and outcomes
Cook Tibio-Pedal RegistryPlanned Enrollment
– 200 patients at up to 12 US and European sites
Patient population
– Patient has an infrainguinal artery occlusion
– Previous attempts to cross the occlusion from an antegrade approach have been
unsuccessful (unless institutional standard of care permits primary retrograde access)
– All techniques to be used for access, lesion crossing, lesion treatment, and vessel
closure are at the investigator’s discretion according to institutional standard of care
Data collected include:
– Procedural information, access site and lesion characteristics, procedural times,
treatments used, and closure methods
– Procedural complications and complications occurring within 30 days following
the procedure
Walker et al. NCVH
Adverse Outcomes
Event Type
Local pain at access site 2.5% (5/199)
Infection at access site 1.0% (2/199)
Bruising at access site 1.0% (2/199)*
Bleeding at access site 1.0% (2/199)
Acute vessel dissection 0.5% (1/199)
Acute vessel thrombosis 0% (0/199)
Compartment syndrome 0% (0/199)
Urgent surgical revascularization 0% (0/199)
• Low (< 3%) complication rate for all events associated with
vascular access site
PERIPHERAL VASCULAR DISEASE
VOL. 28, NO. 6, JUNE 2016 259
Peripheral artery disease (PAD) is of epidemic propor-
tions, currently affecting approximately 202 million
patients worldwide. Its prevalence has increased by
approximately 25% from 2000 to 2010 and its global mag-
nitude continues to rise.1 Simultaneously, the evolution of
technology has led to the use of endovascular revasculariza-
tion as a primary strategy for patients with PAD and critical
limb ischemia (CLI). One of the most vital components of
these procedures is arterial access, and unfortunately it also
represents the rate-limiting step, as it is the most commonly
associated with complications.2,3 Historically, arterial access
has been primarily achieved with the use of palpation, an-
atomic landmarks, fluoroscopic guidance, and combinations
of these maneuvers. However, in current practice, lack of
consensus exists regarding which method is the safest and
most effective.4
Retrograde common femoral artery (CFA) access is the
most frequently utilized approach for endovascular inter-
ventions.5 Careful assessment of the target site for retro-
grade puncture (below the inguinal ligament and above
the bifurcation) is essential to avoid anatomically “ high” or
“ low” arterial access, which accounts for up to 71% of vas-
cular access complications.6 Fluoroscopic guidance has been
recommended to improve accuracy and reduce complica-
tions.7,8 However, randomized trials failed to show superior-
ity of these strategies to palpation of anatomic landmarks.9,10
In an attempt to further improve the technique, the use
of ultrasound guidance (USG) has been attempted, as this
technique had been previously shown to be safe and effec-
tive to guide central venous access.11-13 Arterial access with
USG has now been studied in multiple trials comparing this
approach to palpation and fluoroscopic guidance.14,15 Use of
USG was found to reduce the number of access attempts,
time to access, and complication rates for CFA access when
compared with standard fluoroscopic guidance.14 However,
there was no benefit when compared with palpation, except
for patients with a weak arterial pulse and obesity.15 USG
has also been recommended for less commonly accessed ar-
terial segments, such as the superficial femoral (SFA), popli-
teal, and tibial arteries.16-19 Patients with advanced PAD and
CLI often require unconventional approaches, including the
use of antegrade CFA access and retrograde tibial accesses.
There is a paucity of data regarding the safety and efficacy
of USG access in these scenarios, and how these approach-
es compare with conventional retrograde CFA access. This
article examines the feasibility and immediate outcomes of
Ultrasound-Guided Arterial Access: Outcomes Among
Patients With Peripheral Artery Disease and Critical
Limb Ischemia Undergoing Peripheral Interventions
J.A. Mustapha, MD1; Larry J. Diaz-Sandoval, MD1; Michael R. Jaff, DO2; George Adams, MD3; Robert Beasley, MD4;
Sara Finton, BSN1; Theresa McGoff, BSN1; Larry E. Miller, PhD5; Mohammad Ansari, MD1; Fadi Saab, MD1
ABSTRACT: Object ive. Arterial cannulation is a vital component of endovascular interventions and o en unconventional access
approaches are required due to disease complexity. Historically, varying maneuvers have been utilized to obtain arterial access. Lack
of consensus exists regarding the safest and most e ective method. This study examined the feasibility and immediate outcomes
of ultrasound-guided access in traditional and advanced access approaches. Methods. Data were analyzed from a cohort of 407
patients enrolled in the Peripheral RegIstry of Endovascular Clinical OutcoMEs (PRIME). The 407 patients underwent 649 procedures
with 896 access sites utilized. Access success, immediate outcomes, complications, and length of hospital stay were analyzed. Re-
sults. Mean age was 70 years, and 67% were male. The majority of patients had crit ical limb ischemia (58%), 39% were Rutherford
classification III. Most commonly utilized access sites were common femoral retrograde, common femoral antegrade, posterior tibial,
and anterior tibial arteries (34.6%, 33.0%, 12.1%, and 12.1%, respectively). Mean number of attempts was 1.2, 1.2, 1.5, and 1.4, respec-
tively; median time to access was 39, 45, 41, and 59 seconds, respectively; and access success rate was 99.4%, 97.3%, 90.7%, and
92.6%; respectively. Access-site combinations utilized were femoral antegrade (n = 188), femoral retrograde (n = 185), dual femoral/
t ibio-pedal (n = 130), dual femoral retrograde (n = 44), retrograde tibio-pedal (n = 73), and other (n = 29). Access-related complications
were low overall: hematoma (1.2%), bleeding requiring transfusion/ intervention (1.7%), pseudoaneurysm (1.7%), arteriovenous fistula
(0.3%), aneurysm (0%), compartment syndrome (0%), and death (0%). Conclusion. Utilization of ultrasound-guided arterial access
in this complex cohort was shown to be safe and e ective regardless of arterial bed and approach.
J INVASIVE CARDIOL 2016;28(6):259-264
KEY WORDS: peripheral intervent ions, peripheral vascular disease, crit ical limb ischemia, access-site management
PERIPHERAL INTERVENTION IN PATIENTS W ITH PAD AND CLI MUSTAPHA, ET AL.
260 THE JOURNAL OF INVASIVE CARDIOLOGY®
using USG in accessing a variety of complex arterial beds
in patients with PAD and CLI.
Methods
Data collection. Data were obtained from patients
enrolled in PRIME (Peripheral RegIstry of Endovascular
Clinical OutcoMEs). This prospective clinical registry is
exclusively focused on patients with PAD and CLI and is
designed to explore all aspects of care from initial patient
assessment to treatment and long-term follow-up (through
36 months). PRIME has been approved by the Institutional
Review Board of each participating center and all enrolled
patients provided written informed consent for registry
participation.
Patient population. The first 407 consecutive PRIME
patients who underwent endovascular revascularization be-
tween January 2013 and April 2015 were analyzed. All pe-
ripheral vascular interventions were performed at a single
United States medical center (Metro Health Hospital, Wyo-
ming, Michigan) by four interventional cardiologists specifi-
cally trained in CLI therapy. USG access was performed on
all patients per the center’s standard practice.
Procedural data and outcomes. Demographics,
baseline symptoms, access distr ibution and success, im-
mediate outcomes, and complications (to time of hospi-
tal discharge) were evaluated. Common access-site related
complications were identified per the PRIME standard-
ized data definitions: arteriovenous fistula (AVF) (abnormal
connection between the artery and a vein); hematoma (lo-
calized swelling fi lled with blood resulting in a reduction in
hemoglobin of >3.0 gm/ dL); thrombosis (development of a
blood clot); compartment syndrome (compression within the
limb compromising the circulation and function of the tissues
in that area); aneurysm (weakness in the wall of the artery that
causes an abnormal widening of the vessel); pseudoaneurysm
(disruption and dilation of the wall of the artery, resulting in
a hematoma); and bleeding (according to the Bleeding Aca-
demic Research Consortium [BARC] classification).20
Arterial access sites were grouped in the following categories:
(A) Femoral antegrade (n = 188): single antegrade
CFA or proximal SFA access.
(B) Femoral retrograde (n = 185): single retrograde
CFA or proximal SFA access.
(C) Dual femoral/ tibio-pedal (n = 130): >1 access
site was utilized, including retrograde contralateral
CFA (“ up and over” ) with retrograde tibio-pedal;
or ipsilateral antegrade CFA or proximal SFA with
retrograde tibio-pedal access.
(D) Dual femoral retrograde (n = 44): bilateral retro-
grade CFA access.
(E) Tibio-pedal arterial minimally invasive (TAMI)
retrograde revascularization (n = 73): exclusive
USG tibial access with performance of the entire
lower-extremity revascularization via tibial ap-
proach only.3
Ultrasound-guided access. Ultrasound-guided retro-
grade and/ or antegrade CFA access was commonly per-
formed by the operator using the Site-Rite Vision system
(Bard Peripheral Vascular, Inc). In cases where access was
considered complex (obese patients, fibrotic inguinal re-
gion, etc), an ultrasound technologist was available to pro-
vide assistance with a Philips EPiQ 5 system and an L12-5
MHz transducer (Philips Healthcare). Similarly, in patients
with tibio-pedal access, an ultrasound technologist assisted
with the Philips EpiQ system and the Philips 7-15 MHz
variable frequency hockey stick probe.
Table 1. Baseline pa t ient characterist ics.
Variable Value
Demographics
Age (years) 70 ± 11
Male gender 67%
Body mass index (kg/ m 2) 29 ± 6
Clinical presentat ion
Rutherford grade
2 11/ 407 (3%)
3 158/ 407 (39%)
4 96/407 (23%)
5 131/ 407 (32%)
6 11/ 407 (3%)
Claudicat ion 326/ 405 (80%)
Rest ing pain 156/ 407 (38%)
Neuropathy 97/407 (24%)
Cellulit is 26/407 (6%)
Osteomyelit is 24/ 407 (6%)
Data provided as mean ± standard deviat ion or n/ N (%).
Table 2. Dist ribut ion o f access sit es.
Access Sit e Value
Common femoral ret rograde 310/ 896 (34.6%)
Common femoral antegrade 296/ 896 (33.0%)
Posterior t ibial 108/ 896 (12.1%)
Anterior t ibial 108/ 896 (12.1%)
Superf icial femoral antegrade 25/ 896 (2.8%)
Dorsalis pedis 14/ 896 (1.6%)
Brachial 9/ 896 (1.0%)
Radial 8/ 896 (0.9%)
Superf icial femoral ret rograde 8/ 896 (0.9%)
Peroneal 7/ 896 (0.8%)
Other 3/ 896 (0.3%)
Data provided as mean ± standard deviat ion or n/ N (%).
Tibio-Pedal Access
Tibio-Pedal Access
CTO Crossing
Delivering Therapy
(TAMI)
Abnormal Patterns
Abnormal Patterns
Normal Pattern
Pedal Access Site Management
• Remove Pedal Sheath regardless of the ACT (Target ACT during procedure
200-250)
• Apply external compression device to achieve external hemostasis with week
Doppler signal.
• Remove patient to recovery area
• Release compression device (In case of Boa make it less tight), while maintaining
external hemostasis. This is done every 10 minutes until hemostasis is achieved
• Walk the patient 30 minutes after hemostasis is achieved. If no bleeding, the
patient would be considered for discharge
• Nurse call within 24hours to check on the patient
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Safety Plan
1. Adhere to the same protocol
2. US guided access
3. Anticoagulation (ACT at 200-250)
4. Always use a Sheath – Never sheathless
5. Infusion of TAMI solution (3000 mcg NTG- 5 mg
verapamil @ 6 cc/min)
Conclusion
• Pedal Access is becoming an essential tool to
treat PVD
• Physicians must seek and perfect this skill set
in their institution
• Quality metrics and practice protocols should
be applied in each institution
Pedal Access in CLIWhen to Use it and How to
Avoid Complications
Fadi Saab MD, FACC,FASE,FSCAI
Associate Director of Cardiovascular Laboratories
Co-Director of Pulmonary Embolism and Deep Venous Thrombosis Services
Clinical Assistant Professor-Michigan State University
School of Medicine
Metro Heart and Vascular
Metro Health Hospital