TY - JOUR
T1 - The Clinical Profile and Natural History of Patients Who Fail Screening for Transcatheter Mitral Valve Replacement
T2 - Rationale and Design of the Prospective Multicenter Mitral Valve Screening Survey (MVSS)
AU - Medranda, Giorgio A.
AU - Rogers, Toby
AU - Modine, Thomas
AU - Latib, Azeem
AU - Jorde, Ulrich
AU - Bapat, Vinayak
AU - Sorajja, Paul
AU - Rowland, Megan
AU - Sutton, Joseph A.
AU - Baig, Salman
AU - Asch, Federico M.
AU - Garcia-Garcia, Hector M.
AU - Ben-Dor, Itsik
AU - Satler, Lowell F.
AU - Waksman, Ron
N1 - Funding Information:
MVSS is an investigator-initiated study funded via a research grant provided by Medtronic (Minneapolis, MN, USA). Medtronic had no role in data collection, data analysis, data interpretation, or writing of the manuscript.
Funding Information:
MVSS is an investigator-initiated study funded via a research grant provided by Medtronic (Minneapolis, MN, USA). Medtronic had no role in data collection, data analysis, data interpretation, or writing of the manuscript.Ron Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., and Venous MedTech; receiving institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and being an investor in MedAlliance and Transmural Systems Inc.
Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2023/2
Y1 - 2023/2
N2 - Mitral valve disease is insidious and associated with a decreased quality of life and survival over time. Despite surgery being the standard of care, many patients are at prohibitive surgical risk. Furthermore, a substantial proportion of patients with symptomatic mitral valve disease fail stringent screening criteria for transcatheter mitral valve replacement (TMVR). The natural history of patients who fail screening is not well-characterized, and data are limited on the reasons for screen failure in this population. The Mitral Valve Screening Survey (MVSS) seeks to detail the clinical profile and natural history of patients who fail screening for TMVR. The MVSS is a prospective, multicenter registry enrolling up to 1000 consecutive subjects who, after screening for TMVR, are deemed not to be candidates. Subjects will be followed for 30 days after failing screening for TMVR and annually for up to 5 years with clinical evaluations. The primary study endpoint of the MVSS registry is all-cause mortality at 1 year. Additional secondary endpoints include all-cause mortality, hospitalizations, subsequent mitral valve intervention (transcatheter or surgical), reason for screen failure, and quality-of-life assessments at 30 days and annually up to 5 years of follow-up. The MVSS registry is the first prospective multicenter study to characterize the clinical and anatomical profile of patients who fail screening for TMVR while providing longitudinal clarification on the natural history and outcomes of these patients. Clinical trial registration: Mitral Valve Screening Survey (MVSS), https://clinicaltrials.gov/ct2/show/NCT04736667,
AB - Mitral valve disease is insidious and associated with a decreased quality of life and survival over time. Despite surgery being the standard of care, many patients are at prohibitive surgical risk. Furthermore, a substantial proportion of patients with symptomatic mitral valve disease fail stringent screening criteria for transcatheter mitral valve replacement (TMVR). The natural history of patients who fail screening is not well-characterized, and data are limited on the reasons for screen failure in this population. The Mitral Valve Screening Survey (MVSS) seeks to detail the clinical profile and natural history of patients who fail screening for TMVR. The MVSS is a prospective, multicenter registry enrolling up to 1000 consecutive subjects who, after screening for TMVR, are deemed not to be candidates. Subjects will be followed for 30 days after failing screening for TMVR and annually for up to 5 years with clinical evaluations. The primary study endpoint of the MVSS registry is all-cause mortality at 1 year. Additional secondary endpoints include all-cause mortality, hospitalizations, subsequent mitral valve intervention (transcatheter or surgical), reason for screen failure, and quality-of-life assessments at 30 days and annually up to 5 years of follow-up. The MVSS registry is the first prospective multicenter study to characterize the clinical and anatomical profile of patients who fail screening for TMVR while providing longitudinal clarification on the natural history and outcomes of these patients. Clinical trial registration: Mitral Valve Screening Survey (MVSS), https://clinicaltrials.gov/ct2/show/NCT04736667,
KW - Mitral regurgitation
KW - Mitral stenosis
KW - Mitral valve disease
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U2 - 10.1016/j.carrev.2022.09.003
DO - 10.1016/j.carrev.2022.09.003
M3 - Article
C2 - 36266153
AN - SCOPUS:85147045451
SN - 1553-8389
VL - 47
SP - 72
EP - 75
JO - Cardiovascular Revascularization Medicine
JF - Cardiovascular Revascularization Medicine
ER -