Case Series of Bail-Out Procedures with a Balloon-Expandable Sheath after Unsuccessful Introduction of the NovaFlex Device

Abstract

Objective

Vascular complications remain the main problem of transcatheter aortic valve replacement, despite downsizing of delivery catheter diameter and judicious patient selection. In case of diffusely calcified and/or very tortuous access vessels, the SoloPath Balloon Expandable TransFemoral Introducer (Onset Medical Corporation, Irvine, CA USA), providing the smallest insertion profile of any sheath in its class, may enable exceptional trackability and offer the largest working diameter, thus helping to prevent feared vascular complications. We report the successful use of SoloPath sheath to face six cases of NovaFlex (Edwards Lifesciences Inc, Irvine, CA USA) sheath failed insertion due to vessel tortuosity and calcifications.

Methods

In six patients enrolled for transfemoral transcatheter Edwards SAPIEN XT replacement, resistance to NovaFlex sheath pushing was encountered, subsequent to the bending of the distal portion of the sheath due to vessel tortuosity and calcifications. Damaged Edwards sheaths were exchanged for a SoloPath sheath with a 21-French inner diameter. SoloPath Controlled Deployment Technology design provides the introducer, once expanded, with great radial and pillar resistance.

Results

The unexpanded SoloPath sheath-dilator combination tracked without resistance or kinking over a stiff guide wire through the iliofemoral axis and then was expanded. All transcatheter prostheses were successfully deployed within the native annulus, showing good hemodynamic function.

Conclusions

We report six successful bail-out procedures with the SoloPath Balloon Expandable TransFemoral sheath after unsuccessful introduction of the NovaFlex device. If similar results are confirmed, use of the SoloPath during transcatheter aortic valve replacement may help prevent vascular complications and eliminate the need for other preoperative steps (eg, vascular stenting), therefore reducing procedural mortality, surgical expense, and patient recovery time.

Keywords

Aortic valve stenosis Transcatheter aortic valve replacement Sheath Balloon catheter Cardiac catheterization/intervention

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References

Van Mieghem

N.M.

, Nuis

R.J.

, Piazza

Vascular complications with transcatheter aortic valve implantation using the 18 Fr Medtronic CoreValve System(R): the Rotterdam experience. EuroIntervention. 2010; 5: 673–679.

Ducrocq

, Francis

, Serfaty

J.M.

Vascular complications of transfemoral aortic valve implantation with the Edwards SAPIEN prosthesis: incidence and impact on outcome. EuroIntervention. 2010; 5: 666–672.

Tchetche

, Dumonteil

, Sauguet

Thirty-day outcome and vascular complications after transarterial aortic valve implantation using both Edwards Sapien and Medtronic CoreValve(R) bioprostheses in a mixed population. EuroIntervention. 2010; 5: 659–665.

Kahlert

, Al-Rashid

, Weber

Vascular access site complications after percutaneous transfemoral aortic valve implantation. Herz. 2009; 34: 398–408.

Leon

M.B.

, Piazza

, Nikolsky

Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium. Eur Heart J. 2011; 32: 205–217.

Leon

M.B.

, Smith

C.R.

, Mack

Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010; 363: 1597–1607.

Smith

C.R.

, Leon

M.B.

, Mack

M.J.

Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011; 364: 2187–2198.

Ruiz

C.E.

Optimizing transcatheter aortic valve sizing and minimizing vascular complications. J Am Coll Cardiol. 2012; 59: 128–129.

Onset Medical Corporation Web site. Available at: www.onsetmedical.com. Accessed February 20, 2011.

10.

Available at: http://www.accessdata.fda.gov. Accessed February 20, 2011.

11.

Ferrari

, von Segesser

L.K.

Transcatheter aortic valve implantation (TAVI). State of the art techniques and future perspectives

Swiss Med Wkly. 2010; 140: w13127.

12.

Eggebrecht

, Kahlert

, Thielmann

Usefulness of a novel balloon-expandable vascular sheath for facilitated large-bore arterial access for transcatheter aortic valve implantation. EuroIntervention. 2011; 6: 893–894.