Trial reportJACC. Cardiovascular interventions2015
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.
Trial report in JACC. Cardiovascular interventions, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 47 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Medtronic CoreValve® U.S. Pivotal Trial
Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI: a Randomized Study
Who cites it
47 citing papers in PubMed, 4 syntheses or guidelines pooled it, 110 citations in OpenAlex.
- Pooled it
- Transcatheter Aortic Valve Implantation in Patients With Severe, Symptomatic Aortic Valve Stenosis at Intermediate Surgical Risk: A Health Technology Assessment.Ontario health technology assessment series · 2020Pooled it
- [Systematic review: Validity and transferability of the results of health-economic evaluations of Transcatheter Aortic Valve Implantation].Wiener medizinische Wochenschrift (1946) · 2019Pooled it
- Transcatheter aortic valve implantation for aortic stenosis in high surgical risk patients: A systematic review and meta-analysis.PloS one · 2018Pooled it
- Trial
- Durability of quality of life benefits of transcatheter aortic valve replacement: Long-term results from the CoreValve US extreme risk trial.American heart journal · 2017Trial
- Trial
- Cost-Effectiveness of Transcatheter Aortic Valve Replacement With a Self-Expanding Prosthesis Versus Surgical Aortic Valve Replacement.Journal of the American College of Cardiology · 2016Trial
- Comments on "Hospital procedural costs of surgical aortic valve replacement versus transcatheter aortic valve replacement in low-risk isolated aortic stenosis: a single-center analysis in Japan".General thoracic and cardiovascular surgery · 2026Article
- The Staging of Cardiac Damage for Aortic Stenosis: A Review.Structural heart : the journal of the Heart Team · 2025Review
- Health-related quality of life after minimal-invasive treatment of aortic valve stenosis in the elderly.Journal of thoracic disease · 2024Article
- Clinical Profile and Prognosis of Patients with Left-Sided Infective Endocarditis with Surgical Indication Who Are Not Operated.Microorganisms · 2024Article
- Heart Failure after Aortic Valve Replacement: Incidence, Risk Factors, and Implications.Journal of clinical medicine · 2023Review
- Transcatheter Aortic Valve Implantation and Cardiac Conduction Abnormalities: Prevalence, Risk Factors and Management.Journal of clinical medicine · 2023Review
- Quality of Life, Procedural Success, and Clinical Outcomes following Transcatheter Mitral Valve Repair.International journal of clinical practice · 2023Article
- Financial Incentives for Transcatheter Aortic Valve Implantation in Ontario, Canada: A Cost-Utility Analysis.Journal of the American Heart Association · 2022Article
- Cardiac surgery improves the postoperative frailty score of frail patients.Journal of anesthesia · 2022Article
- Transcatheter aortic valve replacement: when should we say no?Open heart · 2022Article
- Quality of life after transcatheter or surgical aortic valve replacement using the Toronto Aortic Stenosis Quality of Life Questionnaire.Open heart · 2021Observational
- Socioeconomic and Geographic Characteristics of Hospitals Establishing Transcatheter Aortic Valve Replacement Programs, 2012-2018.Circulation. Cardiovascular quality and outcomes · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 9 institutions in 1 country.
Funding
Abstract
objectivesThis 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).
backgroundIn 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.
methodsBetween 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.
resultsOver 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.
conclusionsHealth 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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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.