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This study aims to determine whether intraoperative physiologic measurements of blood flow to the leg during endovascular treatment of Peripheral Arterial Disease (PAD) can predict future clinical outcomes.
Lower extremity peripheral arterial disease (PAD) caused by atherosclerosis can cause cause leg pain, gangrene, and limb loss. PAD is a result of poor blood flow to the extremity, and the emerging most common initial method of interventional treatment is endovascular therapy, for example angioplasty or stenting. The poor blood flow to the extremity can be inferred by the hemodynamic pressure of blood in the leg. These toe or ankle pressure measurements are typically performed before surgery to diagnose PAD, and after surgery as surveillance.
However, endovascular treatment has a high failure rate often exceeding 20% within a year. There is evidence that physiologic measurements prior to treatment and after treatment are closely related to clinical outcomes. This study introduces these physiologic measurements to the operating room, to determine if physiologic improvement can be detected instantaneously during endovascular revascularization. Patients will be followed for a year following surgery to detect hemodynamic and clinical outcomes. The rationale of these intraoperative measurements would be to potentially guide future surgery, by providing real-time hemodynamic feedback to the operator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative Hemodynamic Improvement | The primary outcome will examine the magnitude of change in the Toe-Brachial Index (TBI) between the beginning and the end of the procedure. The two measurements will be taken before- and after- vascular sheaths had been placed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative Hemodynamic Pressures | Diagnostic Test | Secondary analyses will examine the Ankle-Brachial Index, and the absolute limb pressures. In addition, the changes in flow rate of contrast before- and after- intervention will be examined as an indicator of perfusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Limb Event (MALE) | Composite outcome of major amputation above the ankle, major re-intervention in the form of catheter-directed thrombolysis, open bypass or thrombectomy. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Major Amputation | Any ipsilateral leg amputation performed above the joint of the ankle. | 1 Year |
| Minor Amputation | Any ipsilateral leg amputation performed distal to the joint of the ankle. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | As captured by the hospital's Electronic Health Record | 1 Year |
| Amputation-Free Survival | Survival free of major amputation. | 1 Year |
Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing elective or semi-urgent endovascular procedures for lower extremity de-novo atherosclerotic peripheral vascular disease. These patients will be treated at The Ottawa Hospital, Civic Campus, under the care of the Division of Vascular Surgery.
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| Name | Affiliation | Role |
|---|---|---|
| George Wells, PhD, MSc | Cardiovascular Research Methods Centre, University of Ottawa Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital, Civic Campus | Ottawa | Ontario | K1Y 4E9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31444190 | Derived | Rockley M, Jetty P, Wells GA. Protocol for a prospective observational diagnostic study: intraoperative simultaneous limb pressure monitoring (INSTANT) study. BMJ Open. 2019 Aug 22;9(8):e030456. doi: 10.1136/bmjopen-2019-030456. |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D055109 | Ankle Brachial Index |
| ID | Term |
|---|---|
| D001795 | Blood Pressure Determination |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Contrast Flow Rate | Diagnostic Test | A secondary analysis will examine the rate of contrast flow during pre-intervention and post-intervention angiograms, and correlate these findings with hemodynamic measurements recorded during surgery. |
|
|
| 1 Year |
| Target Vessel Re-Intervention | Endovascular, Open, Thrombectomy, Thrombolysis. | 1 Year |
| Target Vessel Patency | Primary: Absence of target vessel occlusion or restenosis >50% Primary Assisted: Patency requiring assistance of subsequent procedure to maintain patency of target vessel Secondary: Patency requiring assistance of subsequent procedure to restore patency of target vessel | 1 Year |
| Improvement in Rutherford's Classification of Peripheral Vascular Disease | Maximal documented categorical state following index revascularization | 1 Year |
| Post-Operative Hemodynamic Measurements | Correlation between intraoperative completion and immediate post-operative measurements, with longer-term surveillance measurements | 1 - 3 Months |