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Matthew R. Reynolds - One of the best experts on this subject based on the ideXlab platform.
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Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Risk.
Circulation, 2019Co-Authors: Suzanne J Baron, John A. House, Elizabeth A. Magnuson, Raj Makkar, Vinod H. Thourani, Howard C. Herrmann, Matthew R. Reynolds, Susheel Kodali, Kaijun Wang, Samir R. KapadiaAbstract:Background: In patients with severe aortic stenosis (AS) at intermediate Surgical Risk, treatment with transcatheter aortic valve replacement (TAVR) or Surgical aortic valve replacement (SAVR) resu...
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health status after transcatheter or Surgical aortic valve replacement in patients with severe aortic stenosis at increased Surgical Risk results from the corevalve us pivotal trial
Jacc-cardiovascular Interventions, 2015Co-Authors: Suzanne V Arnold, Elizabeth A. Magnuson, Suzanne J Baron, Matthew R. Reynolds, Kaijun Wang, Khaja Chinnakondepalli, Michael J Reardon, Peter Tadros, George L Zorn, Brij MainiAbstract:Abstract Objectives This study sought to compare the health status outcomes for patients treated with either self-expanding transcatheter aortic valve replacement (TAVR) or Surgical aortic valve replacement (AVR). Background In patients at increased Surgical Risk, TAVR with a self-expanding bioprosthesis is associated with improved 1-year survival compared with AVR. However, elderly patients may be just as concerned with quality-of-life improvement as with prolonged survival as a goal of treatment. Methods Between 2011 and 2012, 795 patients with severe aortic stenosis at increased Surgical Risk were randomized to TAVR or AVR in the CoreValve US Pivotal Trial. Health status was assessed at baseline, 1 month, 6 months, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short-Form 12 Questionnaire, and EuroQOL 5-dimension questionnaire; growth curve models were used to examine changes over time. Results Over the 1-year follow-up period, disease-specific and generic health status improved substantially for both treatment groups. At 1 month, there was a significant interaction between the benefit of TAVR over AVR and access site. Among surviving patients eligible for iliofemoral (IF) access, there was a clinically relevant early benefit with TAVR across all disease-specific and generic health status measures. Among the non-IF cohort, however, most health status measures were similar for TAVR and AVR, although there was a trend toward early benefit with TAVR on the Short-Form 12 Questionnaire’s physical health scale. There were no consistent differences in health status between TAVR and AVR at the later time points. Conclusions Health status improved substantially in surviving patients with increased Surgical Risk who were treated with either self-expanding TAVR or AVR. TAVR via the IF route was associated with better early health status compared with AVR, but there was no early health status benefit with non-IF TAVR compared with AVR. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902 )
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improved functional status and quality of life in prohibitive Surgical Risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair
Journal of the American College of Cardiology, 2014Co-Authors: Scott D Lim, Howard C. Herrmann, Matthew R. Reynolds, William A Gray, Ted Feldman, Saibal Kar, Andrew Wang, Patrick L Whitlow, Paul A Grayburn, Michael J MackAbstract:Abstract Background Surgical mitral valve repair (SMVR) remains the gold standard for severe degenerative mitral regurgitation (DMR). However, the results with transcatheter mitral valve repair (TMVR) in prohibitive-Risk DMR patients have not been previously reported. Objectives This study aimed to evaluate treatment of mitral regurgitation (MR) in patients with severe DMR at prohibitive Surgical Risk undergoing TMVR. Methods A prohibitive-Risk DMR cohort was identified by a multidisciplinary heart team that retrospectively evaluated high-Risk DMR patients enrolled in the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II studies. Results A total of 141 high-Risk DMR patients were consecutively enrolled; 127 of these patients were retrospectively identified as meeting the definition of prohibitive Risk and had 1-year follow-up (median: 1.47 years) available. Patients were elderly (mean age: 82.4 years), severely symptomatic (87% New York Heart Association class III/IV), and at prohibitive Surgical Risk (STS score: 13.2 ± 7.3%). TMVR (MitraClip) was successfully performed in 95.3%; hospital stay was 2.9 ± 3.1 days. Major adverse events at 30 days included death in 6.3%, myocardial infarction in 0.8%, and stroke in 2.4%. Through 1 year, there were a total of 30 deaths (23.6%), with no survival difference between patients discharged with MR ≤1+ or MR 2+. At 1 year, the majority of surviving patients (82.9%) remained MR ≤2+ at 1 year, and 86.9% were in New York Heart Association functional class I or II. Left ventricular end-diastolic volume decreased (from 125.1 ± 40.1 ml to 108.5 ± 37.9 ml; p Conclusions TMVR in prohibitive Surgical Risk patients is associated with safety and good clinical outcomes, including decreases in rehospitalization, functional improvements, and favorable ventricular remodeling, at 1 year. (Real World Expanded Multi-center Study of the MitraClip System [REALISM]; NCT01931956)
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cost effectiveness of transcatheter aortic valve replacement compared with Surgical aortic valve replacement in high Risk patients with severe aortic stenosis results of the partner placement of aortic transcatheter valves trial cohort a
Journal of the American College of Cardiology, 2012Co-Authors: Matthew R. Reynolds, Elizabeth A. Magnuson, Vinod H. Thourani, Kaijun Wang, Yang Lei, Katherine Vilain, Joshua Walczak, Duane S Pinto, Lars G Svensson, Michael J MackAbstract:Objectives The aim of this study was to evaluate the cost-effectiveness of transcatheter aortic valve replacement (TAVR) compared with Surgical aortic valve replacement (AVR) for patients with severe aortic stenosis and high Surgical Risk. Background TAVR is an alternative to AVR for patients with severe aortic stenosis and high Surgical Risk. Methods We performed a formal economic analysis based on cost, quality of life, and survival data collected in the PARTNER A (Placement of Aortic Transcatheter Valves) trial in which patients with severe aortic stenosis and high Surgical Risk were randomized to TAVR or AVR. Cumulative 12-month costs (assessed from a U.S. societal perspective) and quality-adjusted life-years (QALYs) were compared separately for the transfemoral (TF) and transapical (TA) cohorts. Results Although 12-month costs and QALYs were similar for TAVR and AVR in the overall population, there were important differences when results were stratified by access site. In the TF cohort, total 12-month costs were slightly lower with TAVR and QALYs were slightly higher such that TF-TAVR was economically dominant compared with AVR in the base case and economically attractive (incremental cost-effectiveness ratio Conclusions In the PARTNER trial, TAVR was an economically attractive strategy compared with AVR for patients suitable for TF access. Future studies are necessary to determine whether improved experience and outcomes with TA-TAVR can improve its cost-effectiveness relative to AVR. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 )
Michael J Mack - One of the best experts on this subject based on the ideXlab platform.
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5 year outcomes of transcatheter aortic valve replacement or Surgical aortic valve replacement for high Surgical Risk patients with aortic stenosis partner 1 a randomised controlled trial
The Lancet, 2015Co-Authors: Michael J Mack, John G Webb, Martin B Leon, Craig R Smith, Craig D Miller, Jeffrey W Moses, Murat E Tuzcu, Pamela S Douglas, William N Anderson, Eugene H BlackstoneAbstract:Summary Background The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that mortality at 1 year, 2 years, and 3 years is much the same with transcatheter aortic valve replacement (TAVR) or Surgical aortic valve replacement (SAVR) for high-Risk patients with aortic stenosis. We report here the 5-year outcomes. Methods We did this randomised controlled trial at 25 hospitals, in Canada (two), Germany (one), and the USA (23). We used a computer-generated randomisation sequence to randomly assign high-Risk patients with severe aortic stenosis to either SAVR or TAVR with a balloon-expandable bovine pericardial tissue valve by either a transfemoral or transapical approach. Patients and their treating physicians were not masked to treatment allocation. The primary outcome of the trial was all-cause mortality in the intention-to-treat population at 1 year, we present here predefined outcomes at 5 years. The study is registered with ClinicalTrials.gov, number NCT00530894. Findings We screened 3105 patients, of whom 699 were enrolled (348 assigned to TAVR, 351 assigned to SAVR). Overall mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 11·7%. At 5 years, Risk of death was 67·8% in the TAVR group compared with 62·4% in the SAVR group (hazard ratio 1·04, 95% CI 0·86–1·24; p=0·76). We recorded no structural valve deterioration requiring Surgical valve replacement in either group. Moderate or severe aortic regurgitation occurred in 40 (14%) of 280 patients in the TAVR group and two (1%) of 228 in the SAVR group (p vs 56·6% for those with mild aortic regurgitation or less; p=0·003). Interpretation Our findings show that TAVR as an alternative to surgery for patients with high Surgical Risk results in similar clinical outcomes. Funding Edwards Lifesciences.
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improved functional status and quality of life in prohibitive Surgical Risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair
Journal of the American College of Cardiology, 2014Co-Authors: Scott D Lim, Howard C. Herrmann, Matthew R. Reynolds, William A Gray, Ted Feldman, Saibal Kar, Andrew Wang, Patrick L Whitlow, Paul A Grayburn, Michael J MackAbstract:Abstract Background Surgical mitral valve repair (SMVR) remains the gold standard for severe degenerative mitral regurgitation (DMR). However, the results with transcatheter mitral valve repair (TMVR) in prohibitive-Risk DMR patients have not been previously reported. Objectives This study aimed to evaluate treatment of mitral regurgitation (MR) in patients with severe DMR at prohibitive Surgical Risk undergoing TMVR. Methods A prohibitive-Risk DMR cohort was identified by a multidisciplinary heart team that retrospectively evaluated high-Risk DMR patients enrolled in the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II studies. Results A total of 141 high-Risk DMR patients were consecutively enrolled; 127 of these patients were retrospectively identified as meeting the definition of prohibitive Risk and had 1-year follow-up (median: 1.47 years) available. Patients were elderly (mean age: 82.4 years), severely symptomatic (87% New York Heart Association class III/IV), and at prohibitive Surgical Risk (STS score: 13.2 ± 7.3%). TMVR (MitraClip) was successfully performed in 95.3%; hospital stay was 2.9 ± 3.1 days. Major adverse events at 30 days included death in 6.3%, myocardial infarction in 0.8%, and stroke in 2.4%. Through 1 year, there were a total of 30 deaths (23.6%), with no survival difference between patients discharged with MR ≤1+ or MR 2+. At 1 year, the majority of surviving patients (82.9%) remained MR ≤2+ at 1 year, and 86.9% were in New York Heart Association functional class I or II. Left ventricular end-diastolic volume decreased (from 125.1 ± 40.1 ml to 108.5 ± 37.9 ml; p Conclusions TMVR in prohibitive Surgical Risk patients is associated with safety and good clinical outcomes, including decreases in rehospitalization, functional improvements, and favorable ventricular remodeling, at 1 year. (Real World Expanded Multi-center Study of the MitraClip System [REALISM]; NCT01931956)
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cost effectiveness of transcatheter aortic valve replacement compared with Surgical aortic valve replacement in high Risk patients with severe aortic stenosis results of the partner placement of aortic transcatheter valves trial cohort a
Journal of the American College of Cardiology, 2012Co-Authors: Matthew R. Reynolds, Elizabeth A. Magnuson, Vinod H. Thourani, Kaijun Wang, Yang Lei, Katherine Vilain, Joshua Walczak, Duane S Pinto, Lars G Svensson, Michael J MackAbstract:Objectives The aim of this study was to evaluate the cost-effectiveness of transcatheter aortic valve replacement (TAVR) compared with Surgical aortic valve replacement (AVR) for patients with severe aortic stenosis and high Surgical Risk. Background TAVR is an alternative to AVR for patients with severe aortic stenosis and high Surgical Risk. Methods We performed a formal economic analysis based on cost, quality of life, and survival data collected in the PARTNER A (Placement of Aortic Transcatheter Valves) trial in which patients with severe aortic stenosis and high Surgical Risk were randomized to TAVR or AVR. Cumulative 12-month costs (assessed from a U.S. societal perspective) and quality-adjusted life-years (QALYs) were compared separately for the transfemoral (TF) and transapical (TA) cohorts. Results Although 12-month costs and QALYs were similar for TAVR and AVR in the overall population, there were important differences when results were stratified by access site. In the TF cohort, total 12-month costs were slightly lower with TAVR and QALYs were slightly higher such that TF-TAVR was economically dominant compared with AVR in the base case and economically attractive (incremental cost-effectiveness ratio Conclusions In the PARTNER trial, TAVR was an economically attractive strategy compared with AVR for patients suitable for TF access. Future studies are necessary to determine whether improved experience and outcomes with TA-TAVR can improve its cost-effectiveness relative to AVR. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 )
Harindra C Wijeysundera - One of the best experts on this subject based on the ideXlab platform.
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a cost utility analysis of transcatheter versus Surgical aortic valve replacement for the treatment of aortic stenosis in the population with intermediate Surgical Risk
The Journal of Thoracic and Cardiovascular Surgery, 2018Co-Authors: Avery Hughes, Stephen E Fremes, Saerom Youn, Rebecca Hancockhoward, Peter C Coyte, Harindra C WijeysunderaAbstract:Abstract Objective Although transcatheter aortic valve implantation has been shown to be noninferior to Surgical aortic valve replacement in patients with severe aortic stenosis at intermediate Surgical Risk, the cost-effectiveness of this strategy in this population is unknown. Our objective was to conduct a cost-utility analysis comparing transcatheter aortic valve implantation with Surgical aortic valve replacement in the population with intermediate Risk severe aortic stenosis. Methods A fully probabilistic Markov model with 30-day cycles was constructed from the Canadian third-party payer's perspective to estimate the difference in cost and effectiveness (measured as quality-adjusted life years) of transcatheter aortic valve implantation versus Surgical aortic valve replacement for intermediate-Risk patients over a lifetime time horizon, discounted at 1.5% per annum. Clinical trial data from The Placement of Aortic Transcatheter Valve 2 informed the efficacy inputs. Costs (adjusted to 2016 Canadian dollars) were obtained from the Canadian Institute of Health Information and the Ontario Schedule of Benefits. Incremental cost-effectiveness ratios were calculated. Results In the base-case analysis, total lifetime costs for transcatheter aortic valve implantation were $10,548 higher than Surgical aortic valve replacement but added 0.23 quality-adjusted life years, for an incremental cost-effectiveness ratio of $46,083/quality-adjusted life-years gained. Deterministic 1-way analyses showed that the incremental cost-effectiveness ratio was sensitive to rates of complications and cost of the transcatheter aortic valve implantation prosthesis. There was moderate-to-high parameter uncertainty; transcatheter aortic valve implantation was the preferred option in only 52.7% and 55.4% of the simulations at a $50,000 and $100,000 per quality-adjusted life years willingness-to-pay thresholds, respectively. Conclusions On the basis of current evidence, transcatheter aortic valve implantation may be cost-effective for the treatment of severe aortic stenosis in patients with intermediate Surgical Risk. There remains moderate-to-high uncertainty surrounding the base-case incremental cost-effectiveness ratio.
Peter Wenaweser - One of the best experts on this subject based on the ideXlab platform.
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clinical outcomes of patients with estimated low or intermediate Surgical Risk undergoing transcatheter aortic valve implantation
European Heart Journal, 2013Co-Authors: Peter Wenaweser, Thomas Pilgrim, Christoph Huber, Stefan Stortecky, Sarah Schwander, Dik Heg, Steffen Gloekler, Crochan J Osullivan, Bernhard Meier, Peter JuniAbstract:Aims Transcatheter aortic valve implantation (TAVI) is an established treatment alternative to Surgical aortic valve replacement in high-Risk and inoperable patients and outcomes among patients with estimated low or intermediate Risk remain to be determined. The aim of this study was to assess clinical outcomes among patients with estimated low or intermediate Surgical Risk undergoing TAVI. Methods and results Between August 2007 and October 2011, 389 consecutive patients underwent TAVI and were categorized according to the Society of Thoracic Surgeons (STS) score into low (STS 8%; n = 94, 24.2%) groups for the purpose of this study. Significant differences were found between the groups (low Risk vs. intermediate Risk vs. high Risk) for age (78.2 ± 6.7 vs. 82.7 ± 5.7 vs. 83.7 ± 4.9, P < 0.001), body mass index (28.1 ± 6.1 vs. 26.5 ± 4.9 vs. 24.4 ± 4.6, P < 0.001), chronic renal failure (34 vs. 67 vs. 90%, P < 0.001), all-cause mortality at 30 days (2.4 vs. 3.9 vs. 14.9%, P = 0.001), and all-cause mortality at 1 year (10.1 vs. 16.1 vs. 34.5%, P = 0.0003). No differences were observed with regards to cerebrovascular accidents and myocardial infarction during 1-year follow-up. Conclusion In contemporary practice, TAVI is not limited to inoperable or STS-defined high-Risk patients and should be guided by the decision of an interdisciplinary Heart Team. Compared with patients at calculated high Risk, well-selected patients with STS-defined intermediate or low Risk appear to have favourable clinical outcomes.
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a 3 center comparison of 1 year mortality outcomes between transcatheter aortic valve implantation and Surgical aortic valve replacement on the basis of propensity score matching among intermediate Risk Surgical patients
Jacc-cardiovascular Interventions, 2013Co-Authors: Nicolo Piazza, Sabine Bleiziffer, Peter Wenaweser, Peter De Jaegere, Bindu Kalesan, Nicolas M Van Mieghem, Stuart J Head, Thierry Carrel, Brigitta Gahl, Robert H AndersonAbstract:Objectives This study sought to compare all-cause mortality in patients at intermediate Surgical Risk undergoing transcatheter aortic valve implantation (TAVI) or Surgical aortic valve replacement (SAVR). Background Physicians are selecting “lower” Surgical Risk patients to undergo TAVI. No clinical data exist about the clinical outcomes of TAVI versus SAVR among intermediate-Surgical-Risk patients. Methods We prospectively enrolled symptomatic patients with severe aortic stenosis who underwent TAVI or SAVR. Propensity-score matched pairs of TAVI and SAVR patients with Society of Thoracic Surgeons (STS) scores between 3% and 8% made up the study population. Primary endpoint was all-cause mortality at 1 year. Results Between November 2006 and January 2010, 3,666 consecutive patients underwent either TAVI (n = 782) or SAVR (n = 2,884). Four hundred five TAVI patients were matched to 405 SAVR patients. Of matched TAVI patients, 99 (24%) patients had STS scores 8%. Among patients with STS scores between 3% and 8%, 20 (7.8%) versus 18 (7.1%) patients had died up to 30 days (hazard ratio: 1.12, 95% confidence interval: 0.58 to 2.15, p = 0.74) and 42 (16.5%) versus 43 (16.9%) patients had died up to 1 year (hazard ratio: 0.90, 95% confidence interval: 0.57 to 1.42, p = 0.64) after TAVI and SAVR, respectively. Effects of treatment on 1-year mortality were similar across all subgroups except for sex, with some evidence for a beneficial effect of TAVI in women but not in men (test for interaction p = 0.024). Conclusions Cumulative all-cause mortality at 30 days and 1 year was similar among propensity-score matched TAVI and SAVR patients at intermediate Surgical Risk. (Surgical Replacement and Transcatheter Aortic Valve Implantation [SURTAVI]; NCT01586910 )
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clinical outcomes of patients with severe aortic stenosis at increased Surgical Risk according to treatment modality
Journal of the American College of Cardiology, 2011Co-Authors: Peter Wenaweser, Thomas Pilgrim, Alexander Kadner, Christoph Huber, Stefan Stortecky, Lutz Buellesfeld, Ahmed A Khattab, Fabienne Meuli, Nadja Roth, Balthasar EberleAbstract:Objectives The aim of this study was to assess the role of transcatheter aortic valve implantation (TAVI) compared with medical treatment (MT) and Surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) at increased Surgical Risk. Background Elderly patients with comorbidities are at considerable Risk for SAVR. Methods Since July 2007, 442 patients with severe AS (age: 81.7 ± 6.0 years, mean logistic European System for Cardiac Operative Risk Evaluation: 22.3 ± 14.6%) underwent treatment allocation to MT (n = 78), SAVR (n = 107), or TAVI (n = 257) on the basis of a comprehensive evaluation protocol as part of a prospective registry. Results Baseline clinical characteristics were similar among patients allocated to MT and TAVI, whereas patients allocated to SAVR were younger (p 80 years, p = 0.01), peripheral vascular disease ( Conclusions Among patients with severe AS with increased Surgical Risk, SAVR and TAVI improve survival and symptoms compared with MT. Clinical outcomes of TAVI and SAVR seem similar among carefully selected patients with severe symptomatic AS at increased Risk.
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clinical outcomes of patients with severe aortic stenosis at increased Surgical Risk according to treatment modality
Journal of the American College of Cardiology, 2011Co-Authors: Peter Wenaweser, Thomas Pilgrim, Alexander Kadner, Christoph Huber, Stefan Stortecky, Lutz Buellesfeld, Ahmed A Khattab, Fabienne Meuli, Nadja Roth, Balthasar EberleAbstract:OBJECTIVES: The aim of this study was to assess the role of transcatheter aortic valve implantation (TAVI) compared with medical treatment (MT) and Surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) at increased Surgical Risk. BACKGROUND: Elderly patients with comorbidities are at considerable Risk for SAVR. METHODS: Since July 2007, 442 patients with severe AS (age: 81.7 ± 6.0 years, mean logistic European System for Cardiac Operative Risk Evaluation: 22.3 ± 14.6%) underwent treatment allocation to MT (n = 78), SAVR (n = 107), or TAVI (n = 257) on the basis of a comprehensive evaluation protocol as part of a prospective registry. RESULTS: Baseline clinical characteristics were similar among patients allocated to MT and TAVI, whereas patients allocated to SAVR were younger (p 80 years, p = 0.01), peripheral vascular disease (<0.001), and atrial fibrillation (p = 0.04) were significantly associated with all-cause mortality at 30 months in the multivariate analysis. At 1 year, more patients undergoing SAVR (92.3%) or TAVI (93.2%) had New York Heart Association functional class I/II as compared with patients with MT (70.8%, p = 0.003). CONCLUSIONS: Among patients with severe AS with increased Surgical Risk, SAVR and TAVI improve survival and symptoms compared with MT. Clinical outcomes of TAVI and SAVR seem similar among carefully selected patients with severe symptomatic AS at increased Risk.
Elizabeth A. Magnuson - One of the best experts on this subject based on the ideXlab platform.
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Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Risk.
Circulation, 2019Co-Authors: Suzanne J Baron, John A. House, Elizabeth A. Magnuson, Raj Makkar, Vinod H. Thourani, Howard C. Herrmann, Matthew R. Reynolds, Susheel Kodali, Kaijun Wang, Samir R. KapadiaAbstract:Background: In patients with severe aortic stenosis (AS) at intermediate Surgical Risk, treatment with transcatheter aortic valve replacement (TAVR) or Surgical aortic valve replacement (SAVR) resu...
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health status after transcatheter or Surgical aortic valve replacement in patients with severe aortic stenosis at increased Surgical Risk results from the corevalve us pivotal trial
Jacc-cardiovascular Interventions, 2015Co-Authors: Suzanne V Arnold, Elizabeth A. Magnuson, Suzanne J Baron, Matthew R. Reynolds, Kaijun Wang, Khaja Chinnakondepalli, Michael J Reardon, Peter Tadros, George L Zorn, Brij MainiAbstract:Abstract Objectives This study sought to compare the health status outcomes for patients treated with either self-expanding transcatheter aortic valve replacement (TAVR) or Surgical aortic valve replacement (AVR). Background In patients at increased Surgical Risk, TAVR with a self-expanding bioprosthesis is associated with improved 1-year survival compared with AVR. However, elderly patients may be just as concerned with quality-of-life improvement as with prolonged survival as a goal of treatment. Methods Between 2011 and 2012, 795 patients with severe aortic stenosis at increased Surgical Risk were randomized to TAVR or AVR in the CoreValve US Pivotal Trial. Health status was assessed at baseline, 1 month, 6 months, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short-Form 12 Questionnaire, and EuroQOL 5-dimension questionnaire; growth curve models were used to examine changes over time. Results Over the 1-year follow-up period, disease-specific and generic health status improved substantially for both treatment groups. At 1 month, there was a significant interaction between the benefit of TAVR over AVR and access site. Among surviving patients eligible for iliofemoral (IF) access, there was a clinically relevant early benefit with TAVR across all disease-specific and generic health status measures. Among the non-IF cohort, however, most health status measures were similar for TAVR and AVR, although there was a trend toward early benefit with TAVR on the Short-Form 12 Questionnaire’s physical health scale. There were no consistent differences in health status between TAVR and AVR at the later time points. Conclusions Health status improved substantially in surviving patients with increased Surgical Risk who were treated with either self-expanding TAVR or AVR. TAVR via the IF route was associated with better early health status compared with AVR, but there was no early health status benefit with non-IF TAVR compared with AVR. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902 )
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cost effectiveness of transcatheter aortic valve replacement compared with Surgical aortic valve replacement in high Risk patients with severe aortic stenosis results of the partner placement of aortic transcatheter valves trial cohort a
Journal of the American College of Cardiology, 2012Co-Authors: Matthew R. Reynolds, Elizabeth A. Magnuson, Vinod H. Thourani, Kaijun Wang, Yang Lei, Katherine Vilain, Joshua Walczak, Duane S Pinto, Lars G Svensson, Michael J MackAbstract:Objectives The aim of this study was to evaluate the cost-effectiveness of transcatheter aortic valve replacement (TAVR) compared with Surgical aortic valve replacement (AVR) for patients with severe aortic stenosis and high Surgical Risk. Background TAVR is an alternative to AVR for patients with severe aortic stenosis and high Surgical Risk. Methods We performed a formal economic analysis based on cost, quality of life, and survival data collected in the PARTNER A (Placement of Aortic Transcatheter Valves) trial in which patients with severe aortic stenosis and high Surgical Risk were randomized to TAVR or AVR. Cumulative 12-month costs (assessed from a U.S. societal perspective) and quality-adjusted life-years (QALYs) were compared separately for the transfemoral (TF) and transapical (TA) cohorts. Results Although 12-month costs and QALYs were similar for TAVR and AVR in the overall population, there were important differences when results were stratified by access site. In the TF cohort, total 12-month costs were slightly lower with TAVR and QALYs were slightly higher such that TF-TAVR was economically dominant compared with AVR in the base case and economically attractive (incremental cost-effectiveness ratio Conclusions In the PARTNER trial, TAVR was an economically attractive strategy compared with AVR for patients suitable for TF access. Future studies are necessary to determine whether improved experience and outcomes with TA-TAVR can improve its cost-effectiveness relative to AVR. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 )
