PM-06922 Core Training Home Study Anatomy & Disease State: GLIDEWIRE® Hydrophilic Coated Peripheral Guidewire Portfolio

Core Training Home Study: Anatomy, Disease State, and Guidewire Portfolio

Document Context: Internal use only document (PM-06922) regarding the GLIDEWIRE® Hydrophilic Coated Peripheral Guidewire Portfolio provided by Terumo Interventional Systems.
Primary Learning Objectives: Mastering anatomy, disease state, and treatment options using guidewires.

Anatomy and Influential Factors for Guidewire Use

Artery Systems Categorization: * Visceral. * Radial. * Peripheral.
BMI Statistics: The average American has a $\text{BMI}$ of $26.5$ .
Treatment Algorithm and Product Selection Factors: * Patient’s anatomy. * Previous medical history. * Desired treatment location. * Height of patient. * Tortuosity of the vessels. * Body Mass Index ( $\text{BMI}$ ).

Upper Extremity Anatomy: Radial Access

Major Arteries of the Upper Extremity: * Subclavian Artery: The proximal vessel originating from the aortic arch or brachiocephalic trunk. * Axillary Artery: Continuation of the subclavian artery into the armpit area. * Brachial Artery: The major blood vessel of the (upper) arm. * Radial Artery: Extension from the brachial artery toward the thumb side of the forearm. * Ulnar Artery: Extension from the brachial artery toward the pinky side of the forearm.

Lower Extremity Anatomy: Pelvic Region

Key Pelvic Vessels and Abbreviations: * AO (Aorta): The main artery of the body. * CIA (Common Iliac Artery): Branches from the aorta to supply the pelvis and legs. * Ext IA (External Iliac Artery): The main blood supply to the lower limb. * Int IA (Internal Iliac Artery): Supplies the pelvic walls and viscera. * CFA (Common Femoral Artery): Continuation of the external iliac artery past the inguinal ligament.

Lower Extremity Anatomy: Above the Knee (ATK)

ATK Circulation Characteristics: * The Common Femoral Artery (CFA) bifurcates into the Superficial Femoral Artery (SFA) and the Profunda. * Superficial Femoral Artery (SFA): The primary artery located above the knee. * Profunda (Deep Femoral Artery/DFA): Supplies the posterior thigh and serves as an important vessel for collateral circulation. * Popliteal Artery (POPA): Spans the knee joint; presents unique challenges for disease treatment and management due to its location across a joint.

Lower Extremity Anatomy: Below the Knee (BTK)

BTK Circulation Characteristics: * The transition from the Superficial Femoral Artery (SFA) to the Popliteal Artery occurs across the knee joint. * Three vessels arise from the Popliteal Artery: 1. Anterior Tibial Artery (ATA): The first lateral vessel branching off. 2. Tibial-Peroneal Trunk: Extends from the ATA to the bifurcation of the peroneal and posterior tibial arteries. 3. Posterior Tibial Artery (PTA): Runs medial to the peroneal artery.

Pedal Circulation Anatomy (Foot)

Vessel Supply Distribution: * Anterior Tibial Artery: Supplies the dorsum (top) of the foot. * Peroneal Artery: Supplies the ankle and the heel. * Posterior Tibial Artery: Supplies the posterior and medial portions of the foot.

Peripheral Artery Disease (PAD) Disease State

Terumo Initiatives Utilizing GLIDEWIRES: * CLI: Chronic Limb Ischemia. * PAD: Peripheral Artery Disease. * CCI: Chronic Coronary Insufficiency. * EMBO: Embolization.
PAD Definition and Process: * PAD involves the narrowing of peripheral arteries supplying the legs, arms, and head; it most commonly affects the legs. * It is the result of atherosclerosis. * Atheroma Composition: Consists of a core of cholesterol joined to proteins with a fibrous intravascular covering. * The atherosclerotic process can progress to complete occlusion of medium to large arteries.

Risk Factors and Classification of PAD

Common Risk Factors: * Smoking. * Diabetes. * Obesity (\text{BMI} > 30). * High Blood Pressure (Hypertension). * High Cholesterol. * Age ( $50+$ years). * Family history of PAD, Heart Disease, or Stroke. * Excess levels of homocysteine. * Physical inactivity.
Rutherford Classification Amputation Risks (Without Revascularization within 1 year): * Rutherford Category 4 (Ischemic Rest Pain): $73\%$ of patients will have an amputation. * Rutherford Category 5 (Minor Tissue Loss): $95\%$ of patients will have an amputation. * Rutherford Category 6 (Ulceration/Gangrene): $95\%$ of patients will have an amputation.

Peripheral Arterial Disease (PAD) Continuum

Stages of Presentation: 1. Asymptomatic: Often found during a physical exam using the Ankle Brachial Index ( $\text{ABI}$ ). 2. Intermittent Claudication: Symptomatic stage where patients complain of pain upon exertion. 3. Critical Limb Ischemia (CLI): Characterized by Rest Pain and Tissue Loss.

Claudication: Signs, Symptoms, and Diagnosis

Definition: Pain, cramping, or a sense of fatigue in a muscle group of the lower extremity related to sustained exercise.
Signs and Symptoms: * Most common symptom: Claudication. * Diminished pulses and cramping resulting from loss of arterial blood flow. * Pain spectrum: Ranges from intermittent claudication (during ambulation) to rest pain ( $\text{CLI}$ ). * SFA and Popliteal disease: Typically results in calf pain. * Iliac and bifurcation disease: Typically results in hip, thigh, or buttock pain.
Diagnosis Methods: * Non-Invasive: * Ankle Brachial Index ( $\text{ABI}$ ). * Doppler Ultrasound ( $\text{DUS}$ ). * Magnetic Resonance Angiography ( $\text{MRA}$ ). * Invasive: Peripheral Angiography.
Treatment Goals: Relief of symptoms, preservation of organs and tissues, and limb salvage.
Outcomes Note: Non-diabetics tend to have better acute and long-term results.

Non-Invasive Testing Procedures

Ankle-Brachial Index (ABI): * ABI is the ratio of blood pressure in the lower legs to the blood pressure in the arms. * Calculation Formula: $\text{ABI} = \frac{\text{Systolic BP in the arteries at the ankle and foot}}{\text{Higher of the two systolic BPs in the arms}}$
Duplex Ultrasound (DUS): * Utilized to measure the speed (velocity) of blood flow. * Used to estimate vessel diameter and the percentage of stenosis. * Performed in a non-invasive vascular lab or office setting pre- or post-procedure.

Critical Limb Ischemia (CLI) Statistics and Complications

Condition Definition: A chronic condition caused by severe arterial blockage in lower extremities resulting in severe pain in feet/toes even at rest.
Complications: Sores and wounds that will not heal; left untreated, CLI lead to amputation.
Clinical and Economic Statistics: * Approximately $51\% \text{ to } 73\%$ of major amputations occur without a prior diagnostic angiogram. * Hospitals forgo an estimated $134 to $516 million in annual revenues. * Angiograms reduce the odds of amputation by $90\%$ . * $60\% \text{ to } 71\%$ of patients receive no revascularization. * Amputation is the $6\text{th}$ most expensive surgical procedure in the United States. * $74\%$ of amputees are readmitted for an amputation-related problem within $1$ year.

Treatment Algorithm: TACTIC

TACTIC Planning Framework: * TARGET: What are you trying to treat? * TREATMENT: How do you get to/cross the lesion? * INTERVENE: How will you provide therapy? * CLOSE: How will you close the access point? * ACCESS: Where are you going to access?

Vascular Access Sites and Approaches

Directional Definitions: * Antegrade: Accessing with the direction of blood flow. * Retrograde: Accessing against the direction of blood flow.
Access Strategies: * Contralateral (Up & Over): * Intent is to treat the limb opposite the access site. * Guiding sheaths are typical placed over the Aorto-Iliac bifurcation to the common femoral artery of the symptomatic limb. * Considered more ergonomic for the physician. * Ipsilateral Antegrade Access: * Often necessitated by PAD in the iliac or femoral arteries of the affected limb. * Access site can be more difficult to manage post-procedure. * Often less ergonomic than contralateral access. * Can offer increased support to cross difficult lesions.