Detailed description of patients with complications according to the VARC criteria, and unsuccessful use of the iSleeve sheath
| Patient | iSleeve unsuccessful | VARC major vascular complication | VARC major bleeding complication | VARC minor vascular complication | Age | Sex | Access vessel diameter | Calcification (0–3) | Tortuosity (0–3) | SFAR |
| 1 | Dissection and thrombus distal to puncture site, required aspiration and vascular surgery | Bleeding from access site requiring transfusion of two units of blood | – | 87 | Female | 5.8 | 2 | 2 | 1.26 | |
| 2 | Pseudoaneurysm at access site leading to major bleeding | Bleeding at access site requiring transfusion of three units of blood | Pseudoaneurysm at access site | 89 | Female | 5.4 | 3 | 1 | 1.35 | |
| 3 | Pseudoaneurysm at access site leading to major bleeding | Bleeding at access site with drop in haemoglobin level of 33.0 g/L | Pseudoaneurysm at access site | 85 | Male | 5.3 | 2 | 1 | 1.38 | |
| 4 | Occlusion of femoral artery after MANTA, required vascular surgery | Bleeding after vascular surgery requiring transfusion of two units of blood | – | 80 | Female | 3.9 | 3 | 2 | 1.87 | |
| 5 | – | – | – | Bleeding at access site with unplanned endovascular stenting | 76 | Female | 4.1 | 2 | 1 | 1.78 |
| 6 | – | – | – | Stenosis at access site with unplanned endovascular balloon therapy | 74 | Female | 6 | 1 | 1 | 1.22 |
| 7 | – | – | – | Bleeding at access site with unplanned endovascular stenting | 86 | Female | 5 | 2 | 1 | 1.46 |
| 8 | – | – | – | Bleeding at access site with unplanned endovascular balloon therapy | 95 | Female | 4.9 | 2 | 1 | 1.49 |
| 9 | – | – | – | Femoral occlusion with unplanned endovascular balloon therapy | 71 | Male | 4.4 | 2 | 2 | 1.66 |
| 10 | Could not pass stent in iliac artery with any sheath or valve prosthesis | - | – | – | 88 | Male | 5.6 | 3 | 2 | 1.30 |
| 11 | Damaged sheath | 85 | Female | 5.5 | 1 | 1 | 1.33 | |||
| 12 | Sheath kinked | 81 | Male | 8 | 1 | 2 | 0.91 | |||
| 13 | Invagination of iSleeve after valve delivery | 85 | Female | 4.7 | 2 | 2 | 1.55 |
SFAR, sheath-to-femoral artery ratio; VARC, Valve Academic Research Consortium.