Press Release
Study Links Use of the Baylis Medical RF Transseptal Needle to Procedural Cost-Savings
June 19, 2019
TORONTO, JUNE 19, 2019 – A cost-effectiveness analysis completed by the University of California, San Francisco (UCSF) and Baylis Medical has shown that use of Baylis’ RF transseptal needle results in cost savings per procedure, compared to use of a mechanical transseptal needle.
The study, entitled A Cost-Effectiveness Analysis Comparing the Baylis RF Needle to the Conventional Brockenbrough Needle for Transseptal Punctures, was presented at the Poster Session of the 2019 Heart Rhythm Society (HRS) Scientific Sessions.
Transseptal access is a critical step in the minimally-invasive delivery of therapies for left-heart conditions, such as atrial fibrillation ablations, left atrial appendage closures and mitral valve repair. The NRG® Transseptal Needle, which uses radiofrequency energy to achieve a transseptal puncture rather than mechanical force, is recognized as the standard for left-heart access. It is widely used by physicians given its clinical advantages, such as improved crossing success rates1,2,3 and reduced procedure time1,2,3.
According to the study, despite higher initial investment of the NRG needle, the total cost at 30 days post-procedure was lower when the NRG needle was used than when using a mechanical needle, when accounting for procedural and complication costs.
"The results of our cost-effectiveness analysis are very positive. It is very interesting that the procedural- and complication-associated costs after 30 days are less than with the conventional mechanical needle. Some practicing electrophysiologists may be dissuaded by the initial upfront cost of the Baylis RF needle, and our results are likely to have a significant impact on the practice patterns of proceduralists who perform transseptal punctures,” said Dr. Jose Sanchez on behalf of the UCSF research team.
“While the clinical advantages of the RF needle are long-established, we are pleased to see the cost effectiveness confirmed in this analysis,” said Meghal Khakhar, Vice President of Regulatory and Scientific Affairs at Baylis Medical. “Baylis is proud to offer a clinical solution which reduces the rate of serious complications1,4 to the patient, while offering procedural savings to the healthcare system.”
Read the corresponding abstract on page S511 of May's Heart Rhythm Journal supplement.
About Baylis Medical
Baylis Medical is a leader in the development and commercialization of innovative medical devices in the field of cardiology, with a focus on left-heart access. Headquartered in Canada, and with offices world-wide, our clinical solutions have been Improving the Lives of People Around the World for over 30 years. For more information, visit www.baylismedical.com and connect with us on Twitter, LinkedIn and Instagram.
PRM-00465 EN J-1,2,3 V-1 © Baylis Medical Company Inc., 2019. NRG and the Baylis Medical logo are trademarks and/or registered trademarks of Baylis Medical Company Inc. in the USA and/or other countries. CAUTION: Federal Law (USA) restricts the use of these devices to or by the order of a physician. Before use, consult product labels and Instructions for Use for Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Directions for Use.
1 Winkle RA, Mead RH, Engel G, Patrawala RA. The use of a radiofrequency needle improves the safety and efficacy of transseptal puncture for atrial fibrillation ablation. Heart Rhythm. 2011 Sep;8(9):1411-5.
2 Hsu JC, Badhwar N, Gerstenfeld EP, Lee RJ, Mandyam MC, Dewland TA, Imburgia KE, Hoffmayer KS, Vedantham V, Lee BK, Tseng ZH, Scheinman MM, Olgin JE, Marcus GM. Randomized trial of conventional transseptal needle versus radiofrequency energy needle puncture for left atrial access (the TRAVERSE-LA study). J Am Heart Assoc. 2013 Sep 17;2(5): e000428.
3 Fromentin S, Sarrazin JF, Champagne J, Nault I, Philippon F, Molin F, Blier L, O'Hara G. Prospective comparison between conventional transseptal puncture and transseptal needle puncture with radiofrequency energy. J Interv Card Electrophysiol. 2011 Sep;31(3):237-42.
4 Jauvert G, Grimard C, Lazarus A, Alonso C. Comparison of a radiofrequency powered flexible needle with a
classic rigid Brockenbrough needle for transseptal punctures in terms of safety and efficacy. Heart Lung Circ.
2015 Feb;24(2):173-8.
The study, entitled A Cost-Effectiveness Analysis Comparing the Baylis RF Needle to the Conventional Brockenbrough Needle for Transseptal Punctures, was presented at the Poster Session of the 2019 Heart Rhythm Society (HRS) Scientific Sessions.
Transseptal access is a critical step in the minimally-invasive delivery of therapies for left-heart conditions, such as atrial fibrillation ablations, left atrial appendage closures and mitral valve repair. The NRG® Transseptal Needle, which uses radiofrequency energy to achieve a transseptal puncture rather than mechanical force, is recognized as the standard for left-heart access. It is widely used by physicians given its clinical advantages, such as improved crossing success rates1,2,3 and reduced procedure time1,2,3.
According to the study, despite higher initial investment of the NRG needle, the total cost at 30 days post-procedure was lower when the NRG needle was used than when using a mechanical needle, when accounting for procedural and complication costs.
"The results of our cost-effectiveness analysis are very positive. It is very interesting that the procedural- and complication-associated costs after 30 days are less than with the conventional mechanical needle. Some practicing electrophysiologists may be dissuaded by the initial upfront cost of the Baylis RF needle, and our results are likely to have a significant impact on the practice patterns of proceduralists who perform transseptal punctures,” said Dr. Jose Sanchez on behalf of the UCSF research team.
“While the clinical advantages of the RF needle are long-established, we are pleased to see the cost effectiveness confirmed in this analysis,” said Meghal Khakhar, Vice President of Regulatory and Scientific Affairs at Baylis Medical. “Baylis is proud to offer a clinical solution which reduces the rate of serious complications1,4 to the patient, while offering procedural savings to the healthcare system.”
Read the corresponding abstract on page S511 of May's Heart Rhythm Journal supplement.
About Baylis Medical
Baylis Medical is a leader in the development and commercialization of innovative medical devices in the field of cardiology, with a focus on left-heart access. Headquartered in Canada, and with offices world-wide, our clinical solutions have been Improving the Lives of People Around the World for over 30 years. For more information, visit www.baylismedical.com and connect with us on Twitter, LinkedIn and Instagram.
PRM-00465 EN J-1,2,3 V-1 © Baylis Medical Company Inc., 2019. NRG and the Baylis Medical logo are trademarks and/or registered trademarks of Baylis Medical Company Inc. in the USA and/or other countries. CAUTION: Federal Law (USA) restricts the use of these devices to or by the order of a physician. Before use, consult product labels and Instructions for Use for Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Directions for Use.
1 Winkle RA, Mead RH, Engel G, Patrawala RA. The use of a radiofrequency needle improves the safety and efficacy of transseptal puncture for atrial fibrillation ablation. Heart Rhythm. 2011 Sep;8(9):1411-5.
2 Hsu JC, Badhwar N, Gerstenfeld EP, Lee RJ, Mandyam MC, Dewland TA, Imburgia KE, Hoffmayer KS, Vedantham V, Lee BK, Tseng ZH, Scheinman MM, Olgin JE, Marcus GM. Randomized trial of conventional transseptal needle versus radiofrequency energy needle puncture for left atrial access (the TRAVERSE-LA study). J Am Heart Assoc. 2013 Sep 17;2(5): e000428.
3 Fromentin S, Sarrazin JF, Champagne J, Nault I, Philippon F, Molin F, Blier L, O'Hara G. Prospective comparison between conventional transseptal puncture and transseptal needle puncture with radiofrequency energy. J Interv Card Electrophysiol. 2011 Sep;31(3):237-42.
4 Jauvert G, Grimard C, Lazarus A, Alonso C. Comparison of a radiofrequency powered flexible needle with a
classic rigid Brockenbrough needle for transseptal punctures in terms of safety and efficacy. Heart Lung Circ.
2015 Feb;24(2):173-8.