VARC-2 and MVRC definitions

[Pages:41]VARC-2 and MVRC definitions

Ioannis Iakovou, MD, PhD

Interventional Cardiology Onassis Cardiac Surgery Center

Athens, Greece

THV May 13, 2017

Aims of Valve Academic Research Consortium (VARC)

(i) selecting appropriate clinical endpoints reflecting device, procedure

and patient related effectiveness and safety, and

(ii) standardizing definitions for single and composite clinical endpoints,

for transcatheter aortic valve implantation (TAVI) clinical trials

THV May 13, 2017

EHJ 2011, JACC 2012

The aim of VARC-2 initiative was to (1) revisit the selection and definitions of TAVI clinical endpoints to make

them more suitable to the present and future needs of clinical trials and (2) intended to expand the understanding of patient risk stratification and

case selection.

THV May 13, 2017

JACC 2012

Why do we need standardized definitions?

THV May 13, 2017

Definition of major vascular complications in multicentre registries

THV May 13, 2017

Incidence of major vascular complications according to different definitions

345 consecutive patients underwent transfemoral TAVR

THV May 13, 2017

VARC-2 Definitions

Major Vascular Complications

Minor Vascular Complications

1. Any aortic dissection, rupture, left ventricular perforation, or new apical aneurysm/pseudoaneurysm

2. Access site or access-site related vascular injury (dissection, perforation, stenosis, hematoma, etc.) leading to death, lifethreatening or major bleeding, visceral ischemia, or neurological impairment

1. Access site or access-site related vascular injury (dissection, perforation, stenosis, hematoma, etc.) NOT leading to death, lifethreatening or major bleeding, visceral ischemia, or neurological impairment

2. Distal embolization treated with embolectomy and/or thrombectomy and NOT resulting in amputation or end organ damage

3. Distal embolization requiring vascular surgery, amputation, or irreversible end organ damage

3. Unplanned endovascular stenting or unplanned surgical intervention not meeting

4. Unplanned endovascular or surgical

the criteria for a major vascular complication

intervention associated with death, major

4. Vascular repair or the need for vascular repair

bleeding, visceral ischemia, or neurological

(via surgery, ultrasound-guided compression,

impairment

transcatheter embolization, or stent-graft

5. Any new ipsilateral lower extremity ischemia

6. Surgery for access site-related nerve injury 7. Permanent access site-related nerve injury

Source: Kappetein, et al. JACC 2012

The clinical impact of vascular complications as defined by VARC-1 vs. VARC-2 in patients following TAVI

376 patients undergoing TAVI by the transfemoral or transapical

Cox regression analysis showed major VC with VARC-2 definition to be an independent predictor of mortality (hazard ratio of 3.0, 95% confidence interval: 1.4-6.6, p=0.006)

THV May 13, 2017

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