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NuMED Covered Cheatham-Platinum Stent™ for the treatment or prevention of right ventricular outflow tract conduit disruption during transcatheter pulmonary valve replacement.
Catheter Cardiovasc Interv. 2015 Feb 15; 85(3):421-7.CC

Abstract

OBJECTIVE

Retrospectively assess the frequency of right ventricular outflow tract (RVOT) conduit disruption during transcatheter pulmonary valve replacement (TPVR) and the effectiveness and safety of NuMED Covered Cheatham-Platinum Stents™ (CCPS) for its prevention or treatment.

BACKGROUND

There have been no published reports to date describing the safety and effectiveness of covered stents to prevent or treat RVOT conduit disruption during TPVR.

METHODS

Data regarding 251 TPVR procedures performed at multiple US investigational sites were retrospectively reviewed to explore the incidence and potential predictors of conduit disruption. In addition, data on the use of 69 CCPS implanted in 50 patients during TPVR was reviewed.

RESULTS

The overall incidence of conduit disruption requiring intervention was 6%. The only predictor identified was a very elevated RVOT conduit systolic pressure gradient. A pre-existing conduit tear was present in nine, while 31 developed tears after conduit dilation and three, after TPVR. The CCPS was used prophylactically in seven. Conduit tears were prevented or repaired in 49/50 patients. No CCPS-related acute complications were reported. At 6-month follow-up, no patient had more than mild pulmonary regurgitation and the mean Doppler RVOT gradient (12.7 ± 5.8 mm Hg) comparing favorably with that reported in the Melody TPV® IDE trial (20.0 ± 8.6 mm Hg).

CONCLUSION

CCPS implantation can successfully treat RVOT conduit disruption without negative impact on the TPV function. This retrospective analysis suggests high RVOT conduit systolic pressure gradient is a risk factor for conduit tears during TPVR.

Authors+Show Affiliations

Division of Pediatric Cardiology, Johns Hopkins School of Medicine, Bloomberg Children's Center Baltimore, Maryland.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25257401

Citation

Bishnoi, Ram N., et al. "NuMED Covered Cheatham-Platinum Stent™ for the Treatment or Prevention of Right Ventricular Outflow Tract Conduit Disruption During Transcatheter Pulmonary Valve Replacement." Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions, vol. 85, no. 3, 2015, pp. 421-7.
Bishnoi RN, Jones TK, Kreutzer J, et al. NuMED Covered Cheatham-Platinum Stent™ for the treatment or prevention of right ventricular outflow tract conduit disruption during transcatheter pulmonary valve replacement. Catheter Cardiovasc Interv. 2015;85(3):421-7.
Bishnoi, R. N., Jones, T. K., Kreutzer, J., & Ringel, R. E. (2015). NuMED Covered Cheatham-Platinum Stent™ for the treatment or prevention of right ventricular outflow tract conduit disruption during transcatheter pulmonary valve replacement. Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions, 85(3), 421-7. https://doi.org/10.1002/ccd.25682
Bishnoi RN, et al. NuMED Covered Cheatham-Platinum Stent™ for the Treatment or Prevention of Right Ventricular Outflow Tract Conduit Disruption During Transcatheter Pulmonary Valve Replacement. Catheter Cardiovasc Interv. 2015 Feb 15;85(3):421-7. PubMed PMID: 25257401.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - NuMED Covered Cheatham-Platinum Stent™ for the treatment or prevention of right ventricular outflow tract conduit disruption during transcatheter pulmonary valve replacement. AU - Bishnoi,Ram N, AU - Jones,Thomas K, AU - Kreutzer,Jacqueline, AU - Ringel,Richard E, Y1 - 2014/10/07/ PY - 2014/04/18/received PY - 2014/07/21/revised PY - 2014/09/19/accepted PY - 2014/9/27/entrez PY - 2014/9/27/pubmed PY - 2016/5/18/medline KW - covered cheatham-platinum stent KW - melody TPV® KW - right ventricular outflow tract conduit KW - transcatheter pulmonary valve replacement SP - 421 EP - 7 JF - Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions JO - Catheter Cardiovasc Interv VL - 85 IS - 3 N2 - OBJECTIVE: Retrospectively assess the frequency of right ventricular outflow tract (RVOT) conduit disruption during transcatheter pulmonary valve replacement (TPVR) and the effectiveness and safety of NuMED Covered Cheatham-Platinum Stents™ (CCPS) for its prevention or treatment. BACKGROUND: There have been no published reports to date describing the safety and effectiveness of covered stents to prevent or treat RVOT conduit disruption during TPVR. METHODS: Data regarding 251 TPVR procedures performed at multiple US investigational sites were retrospectively reviewed to explore the incidence and potential predictors of conduit disruption. In addition, data on the use of 69 CCPS implanted in 50 patients during TPVR was reviewed. RESULTS: The overall incidence of conduit disruption requiring intervention was 6%. The only predictor identified was a very elevated RVOT conduit systolic pressure gradient. A pre-existing conduit tear was present in nine, while 31 developed tears after conduit dilation and three, after TPVR. The CCPS was used prophylactically in seven. Conduit tears were prevented or repaired in 49/50 patients. No CCPS-related acute complications were reported. At 6-month follow-up, no patient had more than mild pulmonary regurgitation and the mean Doppler RVOT gradient (12.7 ± 5.8 mm Hg) comparing favorably with that reported in the Melody TPV® IDE trial (20.0 ± 8.6 mm Hg). CONCLUSION: CCPS implantation can successfully treat RVOT conduit disruption without negative impact on the TPV function. This retrospective analysis suggests high RVOT conduit systolic pressure gradient is a risk factor for conduit tears during TPVR. SN - 1522-726X UR - https://www.unboundmedicine.com/medline/citation/25257401/NuMED_Covered_Cheatham_Platinum_Stent™_for_the_treatment_or_prevention_of_right_ventricular_outflow_tract_conduit_disruption_during_transcatheter_pulmonary_valve_replacement_ DB - PRIME DP - Unbound Medicine ER -