30-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results

Firas Zahr; Howard K. Song; Scott M. Chadderdon; Hemal Gada; Mubashir Mumtaz; Timothy Byrne; Merick Kirshner; Tanvir Bajwa; Eric Weiss; Susheel Kodali; Isaac George; John Heiser; William M. Merhi; Jeremy J. Thaden; Angie Zhang; D. Scott Lim; Michael J. Reardon; David H. Adams; Michael J. Mack; Martin B. Leon

doi:10.1016/j.jcin.2021.10.018

30-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results

Firas Zahr, Howard K. Song, Scott M. Chadderdon, Hemal Gada, Mubashir Mumtaz, Timothy Byrne, Merick Kirshner, Tanvir Bajwa, Eric Weiss, Susheel Kodali, Isaac George, John Heiser, William M. Merhi, Jeremy J. Thaden, Angie Zhang, D. Scott Lim, Michael J. Reardon, David H. Adams, Michael J. Mack, Martin B. Leon

Research output: Contribution to journal › Article › peer-review

55 Scopus citations

Abstract

OBJECTIVES: The aim of this study was to evaluate outcomes of transcatheter mitral valve replacement (TMVR) with transfemoral access in patients at prohibitive or high surgical risk.

BACKGROUND: Prohibitive surgical risk may preclude mitral valve replacement surgery in some patients. The investigational Intrepid TMVR system has previously been evaluated using transapical access for delivery of a self-expanding bioprosthetic valve.

METHODS: This prospective, multicenter, nonrandomized early feasibility study evaluated the safety and performance of the Intrepid valve using transfemoral access enabling transseptal delivery in patients with moderate to severe or severe symptomatic mitral regurgitation at high surgical risk. Candidacy was determined by heart teams, with approval by a central screening committee. Echocardiographic data were evaluated by an independent core laboratory. Clinical events were adjudicated by a clinical events committee.

RESULTS: Fifteen patients were enrolled at 6 sites from February 2020 to May 2021. The median age was 80 years, and median Society of Thoracic Surgeons Predicted Risk of Mortality was 4.7%; 87% of patients were men, and 53% had undergone prior sternotomy. Fourteen implants were successful. One patient was converted to surgery during the index procedure. Patients stayed a median of 5 days postprocedure. There were 6 access site bleeds (40%) and 11 iatrogenic atrial septal defect closures (73%). At 30 days, there were no deaths, strokes, or reinterventions. All patients undergoing implantation had trace or no valvular or paravalvular mitral regurgitation, and the mean gradient was 4.7 mm Hg (IQR: 3.0-6.7 mm Hg).

CONCLUSIONS: Thirty-day results from the Intrepid transfemoral TMVR early feasibility study demonstrate excellent valve function and no mortality or stroke. Additional patients and longer follow-up are needed to confirm these findings. ([The Early Feasibility Study of the Intrepid™ TMVR Transseptal System]; NCT02322840).

Original language	English (US)
Pages (from-to)	80-89
Number of pages	10
Journal	JACC: Cardiovascular Interventions
Volume	15
Issue number	1
DOIs	https://doi.org/10.1016/j.jcin.2021.10.018
State	Published - Jan 10 2022

Keywords

Intrepid
TMVR
mitral regurgitation
Mitral Valve Insufficiency/diagnostic imaging
Prospective Studies
Heart Valve Prosthesis
Humans
Mitral Valve/diagnostic imaging
Male
Treatment Outcome
Feasibility Studies
Heart Valve Prosthesis Implantation/adverse effects
Cardiac Catheterization/adverse effects
Aged, 80 and over

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1016/j.jcin.2021.10.018

Cite this

Zahr, F., Song, H. K., Chadderdon, S. M., Gada, H., Mumtaz, M., Byrne, T., Kirshner, M., Bajwa, T., Weiss, E., Kodali, S., George, I., Heiser, J., Merhi, W. M., Thaden, J. J., Zhang, A., Lim, D. S., Reardon, M. J., Adams, D. H., Mack, M. J., & Leon, M. B. (2022). 30-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results. JACC: Cardiovascular Interventions, 15(1), 80-89. https://doi.org/10.1016/j.jcin.2021.10.018

Zahr, F, Song, HK, Chadderdon, SM, Gada, H, Mumtaz, M, Byrne, T, Kirshner, M, Bajwa, T, Weiss, E, Kodali, S, George, I, Heiser, J, Merhi, WM, Thaden, JJ, Zhang, A, Lim, DS, Reardon, MJ, Adams, DH, Mack, MJ & Leon, MB 2022, '30-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results', JACC: Cardiovascular Interventions, vol. 15, no. 1, pp. 80-89. https://doi.org/10.1016/j.jcin.2021.10.018

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title = "30-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results",

abstract = "OBJECTIVES: The aim of this study was to evaluate outcomes of transcatheter mitral valve replacement (TMVR) with transfemoral access in patients at prohibitive or high surgical risk.BACKGROUND: Prohibitive surgical risk may preclude mitral valve replacement surgery in some patients. The investigational Intrepid TMVR system has previously been evaluated using transapical access for delivery of a self-expanding bioprosthetic valve.METHODS: This prospective, multicenter, nonrandomized early feasibility study evaluated the safety and performance of the Intrepid valve using transfemoral access enabling transseptal delivery in patients with moderate to severe or severe symptomatic mitral regurgitation at high surgical risk. Candidacy was determined by heart teams, with approval by a central screening committee. Echocardiographic data were evaluated by an independent core laboratory. Clinical events were adjudicated by a clinical events committee.RESULTS: Fifteen patients were enrolled at 6 sites from February 2020 to May 2021. The median age was 80 years, and median Society of Thoracic Surgeons Predicted Risk of Mortality was 4.7%; 87% of patients were men, and 53% had undergone prior sternotomy. Fourteen implants were successful. One patient was converted to surgery during the index procedure. Patients stayed a median of 5 days postprocedure. There were 6 access site bleeds (40%) and 11 iatrogenic atrial septal defect closures (73%). At 30 days, there were no deaths, strokes, or reinterventions. All patients undergoing implantation had trace or no valvular or paravalvular mitral regurgitation, and the mean gradient was 4.7 mm Hg (IQR: 3.0-6.7 mm Hg).CONCLUSIONS: Thirty-day results from the Intrepid transfemoral TMVR early feasibility study demonstrate excellent valve function and no mortality or stroke. Additional patients and longer follow-up are needed to confirm these findings. ([The Early Feasibility Study of the Intrepid{\texttrademark} TMVR Transseptal System]; NCT02322840).",

keywords = "Intrepid, TMVR, mitral regurgitation, Mitral Valve Insufficiency/diagnostic imaging, Prospective Studies, Heart Valve Prosthesis, Humans, Mitral Valve/diagnostic imaging, Male, Treatment Outcome, Feasibility Studies, Heart Valve Prosthesis Implantation/adverse effects, Cardiac Catheterization/adverse effects, Aged, 80 and over",

author = "Firas Zahr and Song, {Howard K.} and Chadderdon, {Scott M.} and Hemal Gada and Mubashir Mumtaz and Timothy Byrne and Merick Kirshner and Tanvir Bajwa and Eric Weiss and Susheel Kodali and Isaac George and John Heiser and Merhi, {William M.} and Thaden, {Jeremy J.} and Angie Zhang and Lim, {D. Scott} and Reardon, {Michael J.} and Adams, {David H.} and Mack, {Michael J.} and Leon, {Martin B.}",

note = "Publisher Copyright: {\textcopyright} 2022 American College of Cardiology Foundation",

year = "2022",

month = jan,

day = "10",

doi = "10.1016/j.jcin.2021.10.018",

language = "English (US)",

volume = "15",

pages = "80--89",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier",

number = "1",

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TY - JOUR

T1 - 30-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement

T2 - Intrepid TMVR Early Feasibility Study Results

AU - Zahr, Firas

AU - Song, Howard K.

AU - Chadderdon, Scott M.

AU - Gada, Hemal

AU - Mumtaz, Mubashir

AU - Byrne, Timothy

AU - Kirshner, Merick

AU - Bajwa, Tanvir

AU - Weiss, Eric

AU - Kodali, Susheel

AU - George, Isaac

AU - Heiser, John

AU - Merhi, William M.

AU - Thaden, Jeremy J.

AU - Zhang, Angie

AU - Lim, D. Scott

AU - Reardon, Michael J.

AU - Adams, David H.

AU - Mack, Michael J.

AU - Leon, Martin B.

PY - 2022/1/10

Y1 - 2022/1/10

N2 - OBJECTIVES: The aim of this study was to evaluate outcomes of transcatheter mitral valve replacement (TMVR) with transfemoral access in patients at prohibitive or high surgical risk.BACKGROUND: Prohibitive surgical risk may preclude mitral valve replacement surgery in some patients. The investigational Intrepid TMVR system has previously been evaluated using transapical access for delivery of a self-expanding bioprosthetic valve.METHODS: This prospective, multicenter, nonrandomized early feasibility study evaluated the safety and performance of the Intrepid valve using transfemoral access enabling transseptal delivery in patients with moderate to severe or severe symptomatic mitral regurgitation at high surgical risk. Candidacy was determined by heart teams, with approval by a central screening committee. Echocardiographic data were evaluated by an independent core laboratory. Clinical events were adjudicated by a clinical events committee.RESULTS: Fifteen patients were enrolled at 6 sites from February 2020 to May 2021. The median age was 80 years, and median Society of Thoracic Surgeons Predicted Risk of Mortality was 4.7%; 87% of patients were men, and 53% had undergone prior sternotomy. Fourteen implants were successful. One patient was converted to surgery during the index procedure. Patients stayed a median of 5 days postprocedure. There were 6 access site bleeds (40%) and 11 iatrogenic atrial septal defect closures (73%). At 30 days, there were no deaths, strokes, or reinterventions. All patients undergoing implantation had trace or no valvular or paravalvular mitral regurgitation, and the mean gradient was 4.7 mm Hg (IQR: 3.0-6.7 mm Hg).CONCLUSIONS: Thirty-day results from the Intrepid transfemoral TMVR early feasibility study demonstrate excellent valve function and no mortality or stroke. Additional patients and longer follow-up are needed to confirm these findings. ([The Early Feasibility Study of the Intrepid™ TMVR Transseptal System]; NCT02322840).

AB - OBJECTIVES: The aim of this study was to evaluate outcomes of transcatheter mitral valve replacement (TMVR) with transfemoral access in patients at prohibitive or high surgical risk.BACKGROUND: Prohibitive surgical risk may preclude mitral valve replacement surgery in some patients. The investigational Intrepid TMVR system has previously been evaluated using transapical access for delivery of a self-expanding bioprosthetic valve.METHODS: This prospective, multicenter, nonrandomized early feasibility study evaluated the safety and performance of the Intrepid valve using transfemoral access enabling transseptal delivery in patients with moderate to severe or severe symptomatic mitral regurgitation at high surgical risk. Candidacy was determined by heart teams, with approval by a central screening committee. Echocardiographic data were evaluated by an independent core laboratory. Clinical events were adjudicated by a clinical events committee.RESULTS: Fifteen patients were enrolled at 6 sites from February 2020 to May 2021. The median age was 80 years, and median Society of Thoracic Surgeons Predicted Risk of Mortality was 4.7%; 87% of patients were men, and 53% had undergone prior sternotomy. Fourteen implants were successful. One patient was converted to surgery during the index procedure. Patients stayed a median of 5 days postprocedure. There were 6 access site bleeds (40%) and 11 iatrogenic atrial septal defect closures (73%). At 30 days, there were no deaths, strokes, or reinterventions. All patients undergoing implantation had trace or no valvular or paravalvular mitral regurgitation, and the mean gradient was 4.7 mm Hg (IQR: 3.0-6.7 mm Hg).CONCLUSIONS: Thirty-day results from the Intrepid transfemoral TMVR early feasibility study demonstrate excellent valve function and no mortality or stroke. Additional patients and longer follow-up are needed to confirm these findings. ([The Early Feasibility Study of the Intrepid™ TMVR Transseptal System]; NCT02322840).

KW - Intrepid

KW - TMVR

KW - mitral regurgitation

KW - Mitral Valve Insufficiency/diagnostic imaging

KW - Prospective Studies

KW - Heart Valve Prosthesis

KW - Humans

KW - Mitral Valve/diagnostic imaging

KW - Male

KW - Treatment Outcome

KW - Feasibility Studies

KW - Heart Valve Prosthesis Implantation/adverse effects

KW - Cardiac Catheterization/adverse effects

KW - Aged, 80 and over

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DO - 10.1016/j.jcin.2021.10.018

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30-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results

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