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This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath.
Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlideâ„¢ devices to close the primary vascular access site, deployed prior to upsizing sheath size with closure completed at the end of the case (the double "preclose" approach). A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications, complexity, and cost, but the safety of this is unknown. This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath. The use of Femoseal in mild bleedings, and a second Perclose Proglide for moderate to severe bleedings. Compare this SPET technique with double Preclose technique, with two historical cohorts of patients. One cohort of patients with SPET technique since started this technique, and a second cohort with double perclose technique prior to starting SPET technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with one Perclose Proglide | Patients undergoing transfemoral TAVI implantation treated with one Perclose Proglide Suture |
| |
| Patients treated with two Perclose Proglide Suture | Patients undergoing transfemoral TAVI implantation treated with two Perclose Proglide Suture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One Perclose Proglide Suture | Device | One Perclose Proglide Suture |
|
| Measure | Description | Time Frame |
|---|---|---|
| SAFETY:Incidence of Intrahospital Major Vascular Complications and Bleeding type 2 or type >2 (according to VARC 3 criteria) | Intrahospital Major Vascular Complications and Bleeding type 2 or type >2 (according to VARC 3 criteria) | 30 days |
| EFFICACY:Incidence of successful femoral closure | Complete hemostasis at the puncture site with manual compression after the initial perclosure strategy | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness evaluation | Cost-effectiveness evaluation between two techniques | 30 days |
| Incidence of vascular complications (according to VARC3 criteria) | Incidence of vascular complications (according to VARC3 criteria) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing transfemoral TAVI implantation in a single center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| VICENTE SERRA GARCIA, MD, PhD | Contact | 0034932746155 | vctsrr@hotmail.com | |
| BRUNO GARCIA DEL BLANCO, MD, PhD | Contact | 0034932746155 | brunogb51@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall D'Hebron | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27785881 | Background | Kodama A, Yamamoto M, Shimura T, Kagase A, Koyama Y, Tada N, Takagi K, Araki M, Yamanaka F, Shirai S, Watanabe Y, Hayashida K. Comparative data of single versus double proglide vascular preclose technique after percutaneous transfemoral transcatheter aortic valve implantation from the optimized catheter valvular intervention (OCEAN-TAVI) japanese multicenter registry. Catheter Cardiovasc Interv. 2017 Sep 1;90(3):E55-E62. doi: 10.1002/ccd.26686. Epub 2016 Oct 27. | |
| 31713996 |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Two Perclose Proglide Suture | Device | One Perclose Proglide Suture |
|
| 30 days |
| Incidence of bleeding (according to VARC3 criteria) | Incidence of bleeding (according to VARC3 criteria) | 30 days |
| All-cause Mortality | All-cause Mortality 30 days after procedure | 30 days |
| All-cause Mortality | All-cause Mortality 1 year after procedure | 1 year |
| Background |
| Bazarbashi N, Ahuja K, Gad MM, Sammour YM, Kaur M, Karrthik A, Saad AM, Khubber S, Dhaliwal K, Mick SL, Navia JL, Puri R, Reed GW, Krishnaswamy A, Kapadia SR. The utilization of single versus double Perclose devices for transfemoral aortic valve replacement access site closure: Insights from Cleveland Clinic Aortic Valve Center. Catheter Cardiovasc Interv. 2020 Aug;96(2):442-447. doi: 10.1002/ccd.28585. Epub 2019 Nov 12. |
| D014694 |
| Ventricular Outflow Obstruction |