Aortic Valve Stenosis, Structural Valve Degeneration, Structural Valve Deterioration
Conditions
Keywords
Residual Stenosis
Brief summary
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.
Detailed description
Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlide™ 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.
Interventions
DEVICEOne Perclose Proglide Suture
One Perclose Proglide Suture
DEVICETwo Perclose Proglide Suture
One Perclose Proglide Suture
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years * Patients who have undergone Transfemoral TAVI implantation
Exclusion criteria
* Patients who do not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SAFETY:Incidence of Intrahospital Major Vascular Complications and Bleeding type 2 or type >2 (according to VARC 3 criteria) | 30 days | Intrahospital Major Vascular Complications and Bleeding type 2 or type \>2 (according to VARC 3 criteria) |
| EFFICACY:Incidence of successful femoral closure | 30 days | Complete hemostasis at the puncture site with manual compression after the initial perclosure strategy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness evaluation | 30 days | Cost-effectiveness evaluation between two techniques |
| Incidence of vascular complications (according to VARC3 criteria) | 30 days | Incidence of vascular complications (according to VARC3 criteria) |
| Incidence of bleeding (according to VARC3 criteria) | 30 days | Incidence of bleeding (according to VARC3 criteria) |
| All-cause Mortality | 30 days | All-cause Mortality 30 days after procedure |
Countries
Spain
Contacts
Primary ContactVICENTE SERRA GARCIA, MD, PhD
Backup ContactBRUNO GARCIA DEL BLANCO, MD, PhD
Outcome results
None listed