Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes

• Acute occlusion of the target lesion
• Flow-limiting dissection of the target lesion
• Symptomatic thrombus or embolus in treated limb requiring treatment
• Unplanned percutaneous/surgical revascularization or amputation above the ankle of the treated limb
• Access/surgical site complications

• Bleeding events (specify Bleeding Academic Research Consortium (BARC) type - see Appendix 18.2)
• Surgical site infection requiring medication or surgery, wound dehiscence, patch/arterial infection, lymphatic leak requiring surgery

https://www.ncbi.nlm.nih.gov/books/NBK553864/table/ch20.Tab2/#

Stage 0 - Asymptomatic. Stage 1 - Mild claudication - Completes treadmill exercise; Ankle Pressure (AP) after exercise >50 mmHg but at least 20 mmHg lower than resting value.

Stage 2 - Moderate claudication - Between categories 1 and 3. Stage 3 - Severe claudication - Cannot complete standard treadmill exercise and AP after exercise <50 mm Hg.

Stage 4 - Ischemic rest pain - Resting AP <40 mm Hg, flat or barely pulsatile ankle or metatarsal pulse volume recording (PVR); Toe Pressure (TP) < 30 mm Hg.

Stage 5 - Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia- Resting AP < 60 mm Hg, ankle or metatarsal PVR flat or barely pulsatile; TP < 40 mm Hg Stage 6 - Major tissue loss-extending above TM level, functional foot no longer salvageable - Same as category 5

Measured by the Peripheral Artery Questionnaire (PAQ), a 20-question questionnaire measuring peripheral vascular disease affect on quality of life. Questionnaires may be completed in-person or via phone call conducted by the study coordinator.

• Superficial wound infection
• Deep wound infection
• Wound dehiscence
• Pseudoaneurysm identified on physical exam, imaging or angiography
• Hematoma identified on physical exam, imaging or angiography

Patients must meet criteria from both sections:

Radiology: One definitive chest radiological exam (x-ray or CT) with at least one of the following:

• New or progressive and persistent infiltrate
• Consolidation or opacity

Patients with underlying pulmonary or cardiac disease require two serial chest radiological exams (x-ray or CT) taken no less than 12 hours apart, but no more than 7 days apart.

Signs/Symptoms/Laboratory: at least one of the following:

• Fever (>38 C) with no other recognized cause
• Leukopenia (<4000 WBC/mm3) or leukocytosis (≥12,000 WBC/mm3)
• For adults ≥ 70 years old, altered mental status with no other recognized cause and at least one of the following:

• 5% Bronchoalveolar lavage (BAL)
• Positive growth in blood culture not related to another source of infection
• Positive growth in culture of pleural fluid
• Positive quantitative culture from minimally contaminated lower respiratory tract (LRT) specimen

Intubation greater than 48 hours postoperatively

Must meet one of the following TWO criteria within 30 days of the operation:

• fever (>38C)
• urgency
• frequency
• dysuria
• suprapubic tenderness

AND urine culture of >105 colonies/mL urine with no more than two species of organisms

OR two of the following:

• fever (>38C)
• urgency
• frequency
• dysuria
• suprapubic tenderness

AND any of the following:

• dipstick test positive for leukocyte esterase and/or nitrite
• pyuria (>10WBCs/mL or >3 WBC/hpf of unspun urine)
• organisms seen on Gram stain of unspun urine
• two urine cultures with repeated isolation of the same uropathogen with >102 colonies/mL urine in non-voided specimen
• urine culture with <105 colonies/mL urine of single uropathogen in patient being treated with appropriate antimicrobial therapy
• physician's diagnosis
• physician institutes appropriate antimicrobial therapy

The disorder spectrum spans from relatively mild physiologic abnormalities to septic shock. The most significant level is reported using the following criteria: SIRS (Systemic Inflammatory Response Syndrome), clinically recognized by the presence of two or more of the following in the same time frame:

Temp >38 degrees C or 90 bpm RR >20 breaths/min or PaCO2 12,000 cell/mm3, 10% immature (band) forms anion gap acidosis. Report if the patient has clinical signs and symptoms of SIRS listed above and meets either A or B:

A. One of the following:

• Positive blood culture
• Clinical documentation of purulence or positive culture

B. Suspected pre-operative infection or bowel infarction leading to the surgical procedure. Procedural findings must confirm this suspected diagnosis with one or more of the following:

• Confirmed infarcted bowel requiring resection
• Purulence in the operative site
• Enteric contents in the operative site
• Positive intra-operative cultures

Report this variable if the patient has sepsis AND documented organ and/or circulatory dysfunction. Examples of organ dysfunction include: oliguria, acute alteration in mental status, acute respiratory distress. Examples of circulatory dysfunction include: hypotension, requirement of inotropic or vasopressor agents. The presence of pneumatosis along with the presence of SIRS is assigned.

Mechanical failure of an extracardiac graft or prosthesis including myocutaneous flaps and skin grafts requiring return to the operating room, interventional radiology or a balloon angioplasty within 30 days of the operation.

The absence of cardiac rhythm or presence of chaotic cardiac rhythm, intraoperatively or postoperatively, which results in a cardiac arrest requiring the initiation of CPR, which includes chest compressions. Patients are included who are in a pulseless VT or Vfib in in which defibrillation is performed and PEA arrests requiring chest compressions. Patients with automated implantable cardioverter defibrillator (AICD) that fire but the patient has no loss of consciousness should be excluded.

Documentation of one or more of the following changes indicative of acute MI:

• ST elevation >1mm in two or more contiguous leads
• New left bundle branch block
• New q-wave in two or more contiguous leads
• New elevation in troponin greater than 3 times the upper level o f the reference range in the setting of suspected myocardial ischemia

In a patient who did not require dialysis preoperatively, worsening of renal dysfunction postoperatively requiring hemodialysis, peritoneal dialysis, hemofiltration, hemodiafiltration, or ultrafiltration

Initiation of hemodialysis, peritoneal dialysis, hemofiltration, hemodiafiltration or ultrafiltration in a patient not previously on said therapy preoperatively

New diagnosis of blood clot or thrombus within the venous system (superficial or deep) which may be coupled with inflammation and requires treatment. Must be noted within 30 days after the principal operative procedure AND one of the following A or B below:

A.New Diagnosis of a [new] venous thrombosis (superficial or deep), confirmed by a duplex, venogram, CT scan, or any other definitive imaging modality (including direct pathology examination such as autopsy) AND the patient must be treated with anticoagulation therapy and/or placement of a vena cava filter or clipping of the vena cava, or the record indicates that treatment was warranted but there was no additional appropriate treatment option available.

B. As per (A) above, but the patient or decisionmaker has refused treatment. There must be documentation in the medical record of the [patient's] refusal of treatment.

Lodging of a blood clot in the pulmonary artery with subsequent obstruction of blood supply to the lung parenchyma. The blood clots usually originate from the deep leg veins or pelvic venous system. Since there are not always preoperative studies proving that a clot or thrombus was not present preoperatively, the technical specification of the variable requires only a "new diagnosis"- in other words the clot or thrombus was not previously known. A pulmonary embolism must be noted within 30 days after the principal operative procedure AND the following criteria, A AND B below:

A. New diagnosis of a new blood clot in a pulmonary artery

AND

B. The patient has a V-Q scan interpreted as high probability of pulmonary embolism or a positive CT exam, TEE, pulmonary arteriogram, CT angiogram, or any other definitive imaging modality (including direct pathology examination such as autopsy