Samir Kapadia1, William J Stewart1, William N Anderson2, Vasilis Babaliaros3, Ted Feldman4, David J Cohen5, Pamela S Douglas6, Raj R Makkar7, Lars G Svensson1, John G Webb8, S Chiu Wong9, David L Brown10, D Craig Miller11, Jeffrey W Moses12, Craig R Smith12, Martin B Leon12, E Murat Tuzcu13. 1. Cleveland Clinic Foundation, Cleveland, Ohio. 2. Irvine, California. 3. Emory University School of Medicine, Atlanta, Georgia. 4. NorthShore University Health System, Evanston, Illinois. 5. Saint Luke's Mid America Heart Institute, Kansas City, Missouri. 6. Duke Clinical Research Institute, Durham, North Carolina. 7. Cedars-Sinai Medical Center, Los Angeles, California. 8. St. Paul's Hospital/University of British Columbia, Vancouver, British Columbia, Canada. 9. New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York. 10. Medical City Dallas Hospital, Dallas, Texas. 11. Stanford University, Stanford, California. 12. New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York. 13. Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address: tuzcue@ccf.org.
Abstract
OBJECTIVES: The aim of this report is to characterize the impact of balloon aortic valvuloplasty (BAV) in patients not undergoing aortic valve replacement in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial. BACKGROUND: The PARTNER trial is the only randomized trial with independently adjudicated data of inoperable severe symptomatic aortic stenosis patients, allowing outcome analysis of unoperated-on patients. METHODS: The design and initial results of the PARTNER trial (Cohort B) were reported previously. After excluding patients with pre-randomization BAV, we compared patients undergoing BAV within 30 days of randomization (BAV group) with those not having BAV within 30 days of randomization (no BAV group) to characterize the use and impact of BAV. RESULTS: In the PARTNER Cohort B study, 179 inoperable patients were randomized to standard treatment including 39 patients (21.8%) who had undergone a BAV before randomization (previous BAV group). Of the 140 patients who did not have BAV before enrollment in the study, 102 patients (73%) had BAV within 30 days of study randomization (BAV group). Survival at 3 months was greater in the BAV group compared with the no BAV group (88.2%; 95% confidence interval [CI]: 82.0% to 94.5% vs. 73.0%; 95% CI: 58.8% to 87.4%). However, survival was similar at 6-month follow-up (74.5%; 95% CI: 66.1% to 83.0% vs. 73.1%; 58.8% to 87.4%). There was improvement in quality of life parameters when paired comparisons were made between baseline and 30 days and 6 months between the BAV and no BAV groups, but this effect was lost at 12-month follow-up. CONCLUSIONS:BAV improves functional status and survival in the short term, but these benefits are not sustained. BAV for aortic stenosis patients who cannot undergo aortic valve replacement is a useful palliative therapy. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).
RCT Entities:
OBJECTIVES: The aim of this report is to characterize the impact of balloon aortic valvuloplasty (BAV) in patients not undergoing aortic valve replacement in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial. BACKGROUND: The PARTNER trial is the only randomized trial with independently adjudicated data of inoperable severe symptomatic aortic stenosispatients, allowing outcome analysis of unoperated-on patients. METHODS: The design and initial results of the PARTNER trial (Cohort B) were reported previously. After excluding patients with pre-randomization BAV, we compared patients undergoing BAV within 30 days of randomization (BAV group) with those not having BAV within 30 days of randomization (no BAV group) to characterize the use and impact of BAV. RESULTS: In the PARTNER Cohort B study, 179 inoperable patients were randomized to standard treatment including 39 patients (21.8%) who had undergone a BAV before randomization (previous BAV group). Of the 140 patients who did not have BAV before enrollment in the study, 102 patients (73%) had BAV within 30 days of study randomization (BAV group). Survival at 3 months was greater in the BAV group compared with the no BAV group (88.2%; 95% confidence interval [CI]: 82.0% to 94.5% vs. 73.0%; 95% CI: 58.8% to 87.4%). However, survival was similar at 6-month follow-up (74.5%; 95% CI: 66.1% to 83.0% vs. 73.1%; 58.8% to 87.4%). There was improvement in quality of life parameters when paired comparisons were made between baseline and 30 days and 6 months between the BAV and no BAV groups, but this effect was lost at 12-month follow-up. CONCLUSIONS:BAV improves functional status and survival in the short term, but these benefits are not sustained. BAV for aortic stenosispatients who cannot undergo aortic valve replacement is a useful palliative therapy. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).
Authors: Miha Mrak; Jana Ambrožič; Špela Mušič; Simon Terseglav; Bojan Kontestabile; Nikola Lakič; Matjaž Bunc Journal: Wien Klin Wochenschr Date: 2016-03-16 Impact factor: 1.704
Authors: Brandon M Jones; Amar Krishnaswamy; E Murat Tuzcu; Stephanie Mick; Wael A Jaber; Lars G Svensson; Samir R Kapadia Journal: Nat Rev Cardiol Date: 2017-07-06 Impact factor: 32.419
Authors: Brian R Lindman; Marie-Annick Clavel; Patrick Mathieu; Bernard Iung; Patrizio Lancellotti; Catherine M Otto; Philippe Pibarot Journal: Nat Rev Dis Primers Date: 2016-03-03 Impact factor: 52.329
Authors: Julia Rodighiero; Nicolo Piazza; Giuseppe Martucci; Marco Spaziano; Kevin Lachapelle; Benoit de Varennes; Marie-Claude Ouimet; Jonathan Afilalo Journal: BMC Cardiovasc Disord Date: 2020-06-18 Impact factor: 2.298
Authors: Anda Bularga; Rong Bing; Anoop Sv Shah; Philip D Adamson; Miles Behan; David E Newby; Andrew Flapan; Neal Uren; Nick Cruden Journal: Open Heart Date: 2020-09
Authors: Yukihiro Saito; Erik E Lewis; Amish Raval; Giorgio Gimelli; Kurt M Jacobson; Satoru Osaki Journal: Intern Med Date: 2020-10-07 Impact factor: 1.271