Abstract
Background: Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated. Objectives: The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis. Methods: The Global Feasibility Study enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study. Clinical outcomes through last clinical follow-up were adjudicated independently. Results: In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). There were no intraprocedural deaths, 1 instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively. The 1-year survival free of all-cause mortality was 72.4% (95% confidence interval: 62.1% to 80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association function class I/II, and improvements in 6-min walk distance (p < 0.0001) and quality-of-life measurements occurred (p = 0.011). In 73.4% of survivors, the Kansas City Cardiomyopathy Questionnaire score improved by ≥10 points. Conclusions: In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile. Further study to optimize the impact on long-term survival is needed.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1250-1260 |
| Number of pages | 11 |
| Journal | Journal of the American College of Cardiology |
| Volume | 73 |
| Issue number | 11 |
| DOIs | |
| State | Published - Mar 26 2019 |
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Keywords
- mitral
- regurgitation
- surgery
- transcatheter
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
Cite this
Initial Feasibility Study of a New Transcatheter Mitral Prosthesis : The First 100 Patients. / Sorajja, Paul; Moat, Neil; Badhwar, Vinay; Walters, Darren; Paone, Gaetano; Bethea, Brian; Bae, Richard; Dahle, Gry; Mumtaz, Mubashir; Grayburn, Paul; Kapadia, Samir; Babaliaros, Vasilis; Guerrero, Mayra; Satler, Lowell; Thourani, Vinod; Bedogni, Francesco; Rizik, David; Denti, Paolo; Dumonteil, Nicolas; Modine, Thomas; Sinhal, Ajay; Chuang, Michael L.; Popma, Jeffrey J.; Blanke, Philipp; Leipsic, Jonathon; Muller, David.
In: Journal of the American College of Cardiology, Vol. 73, No. 11, 26.03.2019, p. 1250-1260.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Initial Feasibility Study of a New Transcatheter Mitral Prosthesis
T2 - The First 100 Patients
AU - Sorajja, Paul
AU - Moat, Neil
AU - Badhwar, Vinay
AU - Walters, Darren
AU - Paone, Gaetano
AU - Bethea, Brian
AU - Bae, Richard
AU - Dahle, Gry
AU - Mumtaz, Mubashir
AU - Grayburn, Paul
AU - Kapadia, Samir
AU - Babaliaros, Vasilis
AU - Guerrero, Mayra
AU - Satler, Lowell
AU - Thourani, Vinod
AU - Bedogni, Francesco
AU - Rizik, David
AU - Denti, Paolo
AU - Dumonteil, Nicolas
AU - Modine, Thomas
AU - Sinhal, Ajay
AU - Chuang, Michael L.
AU - Popma, Jeffrey J.
AU - Blanke, Philipp
AU - Leipsic, Jonathon
AU - Muller, David
PY - 2019/3/26
Y1 - 2019/3/26
N2 - Background: Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated. Objectives: The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis. Methods: The Global Feasibility Study enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study. Clinical outcomes through last clinical follow-up were adjudicated independently. Results: In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). There were no intraprocedural deaths, 1 instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively. The 1-year survival free of all-cause mortality was 72.4% (95% confidence interval: 62.1% to 80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association function class I/II, and improvements in 6-min walk distance (p < 0.0001) and quality-of-life measurements occurred (p = 0.011). In 73.4% of survivors, the Kansas City Cardiomyopathy Questionnaire score improved by ≥10 points. Conclusions: In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile. Further study to optimize the impact on long-term survival is needed.
AB - Background: Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated. Objectives: The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis. Methods: The Global Feasibility Study enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study. Clinical outcomes through last clinical follow-up were adjudicated independently. Results: In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). There were no intraprocedural deaths, 1 instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively. The 1-year survival free of all-cause mortality was 72.4% (95% confidence interval: 62.1% to 80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association function class I/II, and improvements in 6-min walk distance (p < 0.0001) and quality-of-life measurements occurred (p = 0.011). In 73.4% of survivors, the Kansas City Cardiomyopathy Questionnaire score improved by ≥10 points. Conclusions: In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile. Further study to optimize the impact on long-term survival is needed.
KW - mitral
KW - regurgitation
KW - surgery
KW - transcatheter
UR - http://www.scopus.com/inward/record.url?scp=85062711394&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85062711394&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2018.12.066
DO - 10.1016/j.jacc.2018.12.066
M3 - Article
C2 - 30898200
AN - SCOPUS:85062711394
VL - 73
SP - 1250
EP - 1260
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 11
ER -