Ignite Creation Date:
2024-05-06 @ 12:51 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03865043
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2019-03-05
Brief Title:
Vascular Complications and Bleeding After Transfemoral TAVI
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Vascular Complications and Bleeding After Transfemoral TAVI a Comparison Between Surgical and Percutaneous Approaches
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Since the first implantation by Cribier transcatheter aortic valve implantation TAVI revolutionized the management of severe symptomatic aortic stenosis Indeed TAVI is indicated as an alternative to conventional surgery in patients at high surgical risk or contra-indicated to conventional surgery
However TAVI remains associated with specific complications related to the technics itself dominated by vascular complications and conductive disorders Major vascular complications remain frequent after TAVI despite improvements in operators experience patients selection and lower profile devices Indeed according to the Valve Academic Research Consortium 2 VARC-2 criteria major VC are still reported with an incidence of 15 to 15 of the procedures in registries and may be associated with unfavorable clinical outcomes Currently percutaneous approach PC in transfemoral TAVI is performed in routine considered as a less invasive strategy than the traditional surgical cutdown SC performed in the first TAVI experience Indeed percutaneous approach may facilitate the local anesthesia and does not require the presence of the surgeon in the catheterization laboratory However surgical approach is still performed in many centers allowing a better control of the puncture site with a low rate of vascular complications Several non-randomized studies compared the two approaches with contradictory results No data are available comparing both approaches performed by the same team during the same period
The aim of this study was to compare percutaneous and surgical approaches in terms of vascular complications and bleeding in patients undergoing transfemoral TAVI
However TAVI remains associated with specific complications related to the technics itself dominated by vascular complications and conductive disorders Major vascular complications remain frequent after TAVI despite improvements in operators experience patients selection and lower profile devices Indeed according to the Valve Academic Research Consortium 2 VARC-2 criteria major VC are still reported with an incidence of 15 to 15 of the procedures in registries and may be associated with unfavorable clinical outcomes Currently percutaneous approach PC in transfemoral TAVI is performed in routine considered as a less invasive strategy than the traditional surgical cutdown SC performed in the first TAVI experience Indeed percutaneous approach may facilitate the local anesthesia and does not require the presence of the surgeon in the catheterization laboratory However surgical approach is still performed in many centers allowing a better control of the puncture site with a low rate of vascular complications Several non-randomized studies compared the two approaches with contradictory results No data are available comparing both approaches performed by the same team during the same period
The aim of this study was to compare percutaneous and surgical approaches in terms of vascular complications and bleeding in patients undergoing transfemoral TAVI
Detailed Description:
This prospective monocentric observational study aims to include all patients undergoing TAVI via transfemoral access from November 2017 at Montpellier University Hospital France
All procedures are performed in the same site by 7 medical teams including 4 different surgeons and 9 interventional cardiologists
All patients have severe symptomatic aortic stenosis secondary to degenerative disease confirmed by transthoracic echocardiography mean gradient 40 mmHg andor valve area 1 cm2 and are deemed for TAVI after heart team decision
Before the procedure a multislice computerized tomography MSCT is systematically performed to evaluate the aortic annulus the aorta and to determine the access site
The choice of percutaneous or surgical is at operators discretion according to predictable access site difficulties calcifications tortuosity femoral bifurcation height and global considerations as obesity
Both procedures are performed during the same period our center using both techniques in a common way
TAVI procedure are performed under general anesthesia in the majority of cases
Percutaneous approach The anterior wall of the common femoral artery are punctured under echographic guidance after selection of a site free of calcifications and above the femoral bifurcation and a 6-French sheath was inserted
Two Perclose ProGlide devices Abbott Vascular Santa Clara CA are used to perform the perpendicular preclosing After the deployment of the prosthesis the TAVI sheath is removed and the nodes from the two previously placed ProGlide devices were tightened Final femoral angiographic control is not systematic
Surgical approach A surgical equivalent of the preclose technique untitled the zip technique is performed routinely in our center This technique avoids arterial crossclamping and purse string effect Briefly the femoral artery is exposed through a transversal groin incision the anterior wall of the artery is cleaned from surrounding tissues up to a few centi- meters The most suitable site is chosen free of calcifications allowing a puncture and insertion of a 6-French sheath At the end of the procedure both ends of the sutures are gently pulled to obtain coaptation of the arterial wall
Study endpoints The primary endpoint of our study is a composite of vascular complications and bleeding defined by the modified VARC-2 classification
Secondary end points included complications after TAVI amount of contrast amount of radiation procedure duration hospitalization length
Data assessment Data on patients baseline characteristics procedural details and in-hospital outcomes is collected from a prospective TAVI database
No additional testing or biological samples were specifically required for this study
All procedures are performed in the same site by 7 medical teams including 4 different surgeons and 9 interventional cardiologists
All patients have severe symptomatic aortic stenosis secondary to degenerative disease confirmed by transthoracic echocardiography mean gradient 40 mmHg andor valve area 1 cm2 and are deemed for TAVI after heart team decision
Before the procedure a multislice computerized tomography MSCT is systematically performed to evaluate the aortic annulus the aorta and to determine the access site
The choice of percutaneous or surgical is at operators discretion according to predictable access site difficulties calcifications tortuosity femoral bifurcation height and global considerations as obesity
Both procedures are performed during the same period our center using both techniques in a common way
TAVI procedure are performed under general anesthesia in the majority of cases
Percutaneous approach The anterior wall of the common femoral artery are punctured under echographic guidance after selection of a site free of calcifications and above the femoral bifurcation and a 6-French sheath was inserted
Two Perclose ProGlide devices Abbott Vascular Santa Clara CA are used to perform the perpendicular preclosing After the deployment of the prosthesis the TAVI sheath is removed and the nodes from the two previously placed ProGlide devices were tightened Final femoral angiographic control is not systematic
Surgical approach A surgical equivalent of the preclose technique untitled the zip technique is performed routinely in our center This technique avoids arterial crossclamping and purse string effect Briefly the femoral artery is exposed through a transversal groin incision the anterior wall of the artery is cleaned from surrounding tissues up to a few centi- meters The most suitable site is chosen free of calcifications allowing a puncture and insertion of a 6-French sheath At the end of the procedure both ends of the sutures are gently pulled to obtain coaptation of the arterial wall
Study endpoints The primary endpoint of our study is a composite of vascular complications and bleeding defined by the modified VARC-2 classification
Secondary end points included complications after TAVI amount of contrast amount of radiation procedure duration hospitalization length
Data assessment Data on patients baseline characteristics procedural details and in-hospital outcomes is collected from a prospective TAVI database
No additional testing or biological samples were specifically required for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None