Bedside Modification of Delivery System for Transcatheter...
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Letters RESEARCH CORRESPONDENCE Bedside Modification of Delivery System for Transcatheter Transseptal Mitral Replacement With POULEZ System and SAPIEN-3 Valve Transcatheter mitral valve replacement (TMVR), using a balloon-expandable valve, recently received approval for degenerated surgical mitral prostheses. It is a relatively straightforward procedure because the prior surgical valve frame enforces coaxiality of the new transcatheter valve. By contrast, transcatheter mitral valve-in-ring (ViR) and valve-in- mitral annular calcification (ViM) procedures are challenging because of the high risk of iatrogenic left ventricular outflow tract obstruction (1,2), the comparatively short landing zone, and because coaxiality is difficult to achieve during transseptal implantation. The deflection radius of the Comman- der delivery catheter (Edwards Lifesciences, Irvine, California) is designed to minimize injury to the aortic arch during aortic implantation, but is both too large and too proximal to deflect inside the left atrium during transseptal mitral implantation (Figure 1A). We describe a simple bedside modification to the Commander delivery system to create distal and narrow-curvature deflection during transseptal mitral implantation (Figure 1B), and to achieve good coaxiality during ViR and ViM implantation. We traverse a 135-cm-long 3-0 polypropylene suture through the catheter nosecone (Figure 1C, beyond the balloon, and with a mandrel in place to protect the guidewire lumen), and through a single petal of the valve pusher (Figure 1D). Both are aligned beforehand along the inner curvature of the delivery catheter, opposite the proximal sidearm (Figure 1E). The distal suture is secured with a “stopper knot” (Figure 1F), and the proximal suture is retained alongside the delivery handle. The heart valve can be mounted in the deployment position over the balloon (which requires a larger introducer sheath, such as 26-F Dry-Seal Flex, Gore Medical, Flagstaff, Arizona) or in the standard deployment position proximal to the balloon (which can use the standard eSheath; Edwards Lifesciences). This configuration allows normal TMVR workflow. Once the valve delivery system is across the atrial septum, the pusher is completely retracted proxi- mally to create a proximal fulcrum, and all deflection is removed from the Commander system before using POULEZ (Preparation Of U-stitch to correct Lateral deflection for Endovascular mitral replacement in short landing Zone). The 2 catheters are locked together while taking care to maintain their rotational orientation. POULEZ tension on the free suture ends bends the distal tip of the delivery catheter, which accomplishes medial and anterior deflection to achieve coaxiality with the mitral valve target (Figures 1G and 1H). This is combined with standard pacing, catheter and wire maneuvers, and slow inflation during valve deployment. Afterward, the suture and delivery catheter are removed together. The new method may improve accuracy of TMVR for ViR and ViM because of improved coaxiality and stability during deployment. Limitations include the possibility that suture deflection might displace the crimped TMVR device, especially in severe mitral stenosis without balloon pre-dilatation, and our limited clinical experience to date (n ¼ 13 proced- ures). When we used a guidewire instead of a polypropylene suture for the initial 2 procedures, we had the complications of difficulty crossing the septum. Since we have changed the deflection mechanism from a guidewire to a polypropylene su- ture, we had only 1 case that we have been unable to deflect the delivery system with POULEZ, with resultant poor coaxiality because of extreme calcification of the mitral annulus and leaflets. *Vasilis Babaliaros, MD Adam B. Greenbaum, MD Norihiko Kamioka, MD Jaffar M. Khan, BM BCh Toby Rogers, BM BCh Frank Corrigan, MD Stamatios Lerakis, MD Patrick Gleason, MD JACC: CARDIOVASCULAR INTERVENTIONS VOL. 11, NO. 12, 2018 ISSN 1936-8798/$36.00
Transcript of Bedside Modification of Delivery System for Transcatheter...
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Letters
RESEARCH CORRESPONDENCE
Bedside Modification ofDelivery System forTranscatheterTransseptal MitralReplacement WithPOULEZ System andSAPIEN-3 Valve
Transcatheter mitral valve replacement (TMVR),using a balloon-expandable valve, recently receivedapproval for degenerated surgical mitral prostheses.It is a relatively straightforward procedure becausethe prior surgical valve frame enforces coaxiality ofthe new transcatheter valve. By contrast,transcatheter mitral valve-in-ring (ViR) and valve-in-mitral annular calcification (ViM) procedures arechallenging because of the high risk of iatrogenic leftventricular outflow tract obstruction (1,2), thecomparatively short landing zone, and becausecoaxiality is difficult to achieve during transseptalimplantation. The deflection radius of the Comman-der delivery catheter (Edwards Lifesciences, Irvine,California) is designed to minimize injury to the aorticarch during aortic implantation, but is both too largeand too proximal to deflect inside the left atriumduring transseptal mitral implantation (Figure 1A).
We describe a simple bedside modification to theCommander delivery system to create distal andnarrow-curvature deflection during transseptal mitralimplantation (Figure 1B), and to achieve goodcoaxiality during ViR and ViM implantation.
We traverse a 135-cm-long 3-0 polypropylenesuture through the catheter nosecone (Figure 1C,beyond the balloon, and with a mandrel in place toprotect the guidewire lumen), and through a singlepetal of the valve pusher (Figure 1D). Both are alignedbeforehand along the inner curvature of the deliverycatheter, opposite the proximal sidearm (Figure 1E).The distal suture is secured with a “stopper knot”(Figure 1F), and the proximal suture is retained
alongside the delivery handle. The heart valve can bemounted in the deployment position over the balloon(which requires a larger introducer sheath, such as26-F Dry-Seal Flex, Gore Medical, Flagstaff, Arizona)or in the standard deployment position proximal tothe balloon (which can use the standard eSheath;Edwards Lifesciences).
This configuration allows normal TMVR workflow.Once the valve delivery system is across the atrialseptum, the pusher is completely retracted proxi-mally to create a proximal fulcrum, and all deflectionis removed from the Commander system before usingPOULEZ (Preparation Of U-stitch to correct Lateraldeflection for Endovascular mitral replacement inshort landing Zone). The 2 catheters are lockedtogether while taking care to maintain their rotationalorientation. POULEZ tension on the free suture endsbends the distal tip of the delivery catheter, whichaccomplishes medial and anterior deflection toachieve coaxiality with the mitral valve target(Figures 1G and 1H). This is combined with standardpacing, catheter and wire maneuvers, and slowinflation during valve deployment. Afterward, thesuture and delivery catheter are removed together.
The new method may improve accuracy of TMVRfor ViR and ViM because of improved coaxiality andstability during deployment. Limitations include thepossibility that suture deflection might displace thecrimped TMVR device, especially in severe mitralstenosis without balloon pre-dilatation, and ourlimited clinical experience to date (n ¼ 13 proced-ures). When we used a guidewire instead of apolypropylene suture for the initial 2 procedures, wehad the complications of difficulty crossing theseptum. Since we have changed the deflectionmechanism from a guidewire to a polypropylene su-ture, we had only 1 case that we have been unable todeflect the delivery system with POULEZ, withresultant poor coaxiality because of extremecalcification of the mitral annulus and leaflets.
*Vasilis Babaliaros, MDAdam B. Greenbaum, MDNorihiko Kamioka, MDJaffar M. Khan, BM BChToby Rogers, BM BChFrank Corrigan, MDStamatios Lerakis, MDPatrick Gleason, MD
FIGURE 1 Transcatheter Transseptal Mitral Replacement With POULEZ System and SAPIEN-3 Valve
Bedside modification of delivery system for transcatheter transseptal mitral replacement with POULEZ (Preparation Of U-stitch to correct Lateral
deflection for Endovascular mitral replacement in short landing Zone) system and SAPIEN-3 valve. (A) Concept of POULEZ: valve deployment with
standard flexion. (B) Concept of POULEZ: valve deployment with POULEZ. (C) The needle and the suture traverse the nose cone from right to left (arrow).
(D) The free end of the suture is driven through the pusher and exits 180� opposite the side arm (arrow). (E) POULEZ system before valve mounting.
(F) The transcatheter valve is crimped on the balloon and the suture in the final deployment position (asterisk ¼ stopper knot). (G) Tight curvature
provided by the POULEZ system. (H) Good coaxiality (mitral ring plane [white line] and valve axis [yellow line]) due to the use of POULEZ system.
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Altayyeb Yousef, MDDennis W. Kim, MD, PhDNeil Holtz, RCIS, EMT-PBradley Leshnower, MDRobert A. Guyton, MDRobert J. Lederman, MD
*Emory University Hospital F6061364 Clifton RoadAtlanta, Georgia 30322E-mail: [email protected]://doi.org/10.1016/j.jcin.2018.03.015
� 2018 by the American College of Cardiology Foundation. Published by Elsevier.
Please note: Supported using intramural funds, Emory Structural Heart andValve Center, and by National Institutes of Health grant Z01-HL006040. Dr.Babaliaros is a consultant for and received research grant support from AbbottVascular and Edwards Lifesciences. Dr. Greenbaum has been a proctor for
Edwards Lifesciences and St. Jude Medical. Dr. Lerakis has been a consultant forEdwards Lifesciences and Abbott Vascular. Dr. Kim has been a consultant forEdwards Lifesciences; and a proctor for B. Braun. Dr. Leshnower has served onthe Speakers Bureau for Medtronic. Dr. Guyton has been a national surgical co-principal investigator for Edwards Lifesciences’ TMVR trial. All other authorshave reported that they have no relationships relevant to the contents of thispaper to disclose.
REF ER ENCES
1. Guerrero M, Wang DD, Himbert D, et al. Short-term results of alcoholseptal ablation as a bail-out strategy to treat severe left ventricularoutflow tract obstruction after transcatheter mitral valve replacement inpatients with severe mitral annular calcification. Catheter Cardiovasc Interv2017;90:1220–6.
2. Babaliaros VC, Greenbaum AB, Khan JM, et al. Intentional percutaneouslaceration of the anterior mitral leaflet to prevent outflow obstruction duringtranscatheter mitral valve replacement first-in-human experience. J Am CollCardiol Intv 2017;10:798–809.
