Cresskill, NJ, United States
Cresskill, NJ, United States
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Hayashidaa K.,Institute Hospitalier Jacques Cartier | Romanob M.,Vascular Therapies | Lefevrea T.,Institute Hospitalier Jacques Cartier | Chevaliera B.,Institute Hospitalier Jacques Cartier | And 4 more authors.
European Journal of Cardio-thoracic Surgery | Year: 2013

Objectives: Transcatheter aortic valve implantation (TAVI) in patients with poor peripheral vessels still remains problematic, as the transapical approach is not always feasible and is sometimes associated with myocardial damage, bleeding, post-procedural chest pain and pleural effusion. In order to address these issues, we adopted the recently introduced transaortic (TAo) approach. The purpose of this study was to evaluate the efficacy and safety of the TAo-TAVI approach using both the Sapien XT and the CoreValve according to VARC criteria. Methods: Of 492 patients (October 2006 to February 2012), TAo-TAVI was performed in 94 consecutive patients with unfavourable peripheral access between January 2011 and February 2012. Aortic root condition, valve anatomy and annulus size were carefully assessed by multidetector computed tomography (MDCT) for possible TAo-TAVI. The aorta was exposed through an inverted 'T' manubriotomy. After retrograde guidewire crossing of the aortic valve, sheath insertion allowed device positioning and deployment subsequent to balloon valvuloplasty. Results: Mean age was 84.1 ± 5.4 years (67-96) and logistic EuroSCORE 17.6 ± 10.2%. The Sapien XT was used in 88.3% and the CoreValve in 11.7% of patients. Full sternotomy allowed concomitant complete off-pump revascularization (2-4 grafts) in 11 patients. Device success rate was 92.6%. Paravalvular leak =2/4 was observed in 7.4%. Conversion to open chest surgery was required in 5.3% (3 aortic dissections, 1 valve migration and 1 left main occlusion). Three cerebrovascular accidents (2 transient ischaemia and 1 delayed stroke) were noted. Transfusion =4 units was performed in 12 patients (12.8%). Intensive care unit (ICU) and total hospital stay were 4.9 ± 5.0 and 12.2 ± 6.2 days, respectively. Thirty-day mortality and combined safety endpoint were reported in 7.4 and 16.0%, respectively. Conclusions: The TAo approach for both Sapien XT and CoreValve implantation can be used with satisfactory clinical outcome and an acceptable risk. This access route could prove a valid alternative to the transapical approach. © The Author 2013.


This invention is a prosthetic device generally placed on the outside surface of the vessel or graft which then elutes antiproliferative drugs or agents from a drug-eluting matrix material. Methods of perivascular antiproliferative drug administration also are disclosed.


Devices and methods for reducing, eliminating, preventing, suppressing, or treating tissue responses to hemostatic devices e.g., biological sealants or vascular procedures are disclosed. The invention employs a combination of resorbable, biocompatible matrix materials and a variety of therapeutic agents, such as antiproliferatives or antibiotics, applied to a vascular puncture or incision to achieve hemostasis following diagnostic or interventional vascular catheterizations and to treat neointimal hyperplasia and stenosis. A matrix of a material such as collagen provides a reservoir of a therapeutic agent such as rapamycin (sirolimus) and its derivatives and analogs for delivery at a tissue site at risk for vasculoproliferation, infection, inflammation, fibrosis or other tissue responses.


Devices and methods for reducing, eliminating, preventing, suppressing, or treating tissue responses to hemostatic devices e.g., biological sealants or vascular procedures are disclosed. The invention employs a combination of resorbable, biocompatible matrix materials and a variety of therapeutic agents, such as antiproliferatives or antibiotics, applied to a vascular puncture or incision to achieve hemostasis following diagnostic or interventional vascular catheterizations and to treat neointimal hyperplasia and stenosis. A matrix of a material such as collagen provides a reservoir of a therapeutic agent such as rapamycin (sirolimus) and its derivatives and analogs for delivery at a tissue site at risk for vasculoproliferation, infection, inflammation, fibrosis or other tissue responses.


A method of preventing or treating vasculoproliferative disease in vascular structures, which comprises the step of: administering extravascularly and locally an antiproliferative effective amount of an rapamycin to the vascular structure.


Trademark
Vascular Therapies | Date: 2015-02-09

A combination drug product, namely, a formulation of sirolimus incorporated within a collagen membrane, which, as an implantable drug carrier, enables local delivery of sirolimus to the vascular wall, administered by physicians during surgery.


Trademark
Vascular Therapies | Date: 2012-01-10

A combination drug product, namely, a formulation of sirolimus incorporated within a collagen membrane, which, as an implantable drug carrier, enables local delivery of sirolimus to the vascular wall.


Trademark
Vascular Therapies | Date: 2012-01-10

A combination drug product, namely, a formulation of sirolimus incorporated within a collagen membrane, which, as an implantable drug carrier, enables local delivery of sirolimus to the vascular wall.


Trademark
Vascular Therapies | Date: 2015-02-09

A combination drug product, namely, a formulation of sirolimus incorporated within a collagen membrane, which, as an implantable drug carrier, enables local delivery of sirolimus to the vascular wall.

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