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

doi:10.1016/S0140-6736(15)60308-7

The Lancet

Volume 385, Issue 9986, 20–26 June 2015, Pages 2477-2484

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https://doi.org/10.1016/S0140-6736(15)60308-7 Get rights and content

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<0·0001), and was associated with increased 5-year risk of mortality in the TAVR group (72·4% for moderate or severe aortic regurgitation 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.

Introduction

Transcatheter aortic valve replacement (TAVR) is an alternative to surgical valve replacement in high-risk patients with aortic stenosis.1, 2 The Placement of Aortic Transcatheter Valves (PARTNER) study is a randomised trial comparing TAVR with standard-of-care treatments in both inoperable and high surgical risk patients with aortic stenosis. 1-year mortality after TAVR was superior to standard non-operative treatment in patients who could not have surgery and was non-inferior to surgical aortic valve replacement (SAVR) in high-risk patients who could have surgery.3, 4 These findings were maintained at 2 years and 3 years.5, 6, 7 This report describes the final 5-year clinical and valve performance outcomes for high-risk patients in the PARTNER-1 trial.

Section snippets

Study design and participants

Details of the trial have been previously published.⁴ We did this randomised controlled trial at 25 hospitals: two in Canada, one in Germany, and 22 in the USA. Inclusion criteria were severe symptomatic aortic stenosis (aortic valve area ≤0·8 cm², and resting or inducible peak velocity ≥4 m/s or a mean valve gradient ≥40 mm Hg) and high-risk status for SAVR, as assessed by a heart team, which included experienced surgeons. Patients were considered to be at high surgical risk if they had

Results

We screened 3105 patients, of whom 699 were enrolled: 348 assigned to TAVR and 351 assigned to SAVR (figure 1). The appendix shows baseline characteristics. Four patients in the TAVR group did not receive it, five patients were lost to follow-up and four withdrew after receiving the procedure. In the SAVR group, 38 patients did not receive the allocated procedure, mainly because of patient decision not to undergo surgery; 19 of these withdrew immediately. 12 patients assigned to SAVR were lost

Discussion

The final 5-year follow-up of high risk surgical patients shows equivalent outcomes after TAVR and SAVR. We detected no significant differences in all-cause mortality, cardiovascular mortality, stroke, or need for repeat hospital admission. Functional outcomes were also similar and preservation of valve haemodynamics was equivalent in both groups. Although we recorded no evidence of structural valve deterioration in either group, moderate or severe aortic regurgitation caused by paravalvular

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The treatment of severe aortic stenosis (SAS) has evolved rapidly with the advent of minimally invasive structural heart interventions. Transcatheter aortic valve replacement has allowed patients to undergo definitive SAS treatment achieving faster recovery rates compared to valve surgery. Not infrequently, patients are admitted/diagnosed with SAS after a fall associated with a hip fracture (HFx). While urgent orthopedic surgery is key to reduce disability and mortality, untreated SAS increases the perioperative risk and precludes physical recovery. There is no consensus on what the best strategy is either hip correction under hemodynamic monitoring followed by valve replacement or preoperative balloon aortic valvuloplasty to allow HFx surgery followed by valve replacement. However, preoperative minimalist transcatheter aortic valve replacement may represent an attractive strategy for selected patients. We provide a management pathway that emphasizes an early multidisciplinary approach to optimize time for hip surgery to improve orthopedic and cardiovascular outcomes in patients presenting with HFx-SAS.
Complications in transcatheter aortic valve replacement: A comprehensive analysis and management strategies
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Transcatheter Aortic Valve Replacement (TAVR) marks a significant advancement in treating aortic stenosis (AS), especially for patients with high surgical risks. This concise review outlines TAVR's development, its broader application to include lower-risk patients, and innovations in the device and procedural technology. Clinical trials, notably the PARTNER series, affirm TAVR's efficacy, showing it matches or surpasses surgical aortic valve replacement (SAVR) in mortality reduction, hemodynamic benefits, and symptom alleviation, including heart failure. However, TAVR entails complications such as paravalvular leakage (PVL), conduction disorders, and increased cerebrovascular event risks. We evaluate these issues, their prevalence, causative factors, and clinical consequences, emphasizing improvements in valve design and technique that have significantly lowered PVL rates. The role of aortic valve anatomy and calcification in PVL and conduction issues is analyzed, underlining the necessity for meticulous patient selection and procedural planning. Further, the review delves into cerebrovascular event risks, their origins, and preventative strategies, including cerebral protection devices and the judicious use of anticoagulant and antiplatelet therapies. TAVR presents a less invasive, promising alternative to SAVR, but requires careful complication management to optimize patient results. Ongoing innovation and research are vital for advancing TAVR's techniques, improving valve designs, and extending its reach, thereby enhancing AS patients' quality of life.
Concomitant transthyretin cardiac amyloidosis in patients undergoing TAVR for aortic stenosis: A systemic review and meta-analysis
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Transcatheter aortic valve replacement (TAVR) is a successful treatment for aortic stenosis (AS) patients, and previous studies indicate favorable outcomes for those with concomitant aortic stenosis and transthyretin-associated cardiac amyloidosis (TTRCA-AS). However, the impact of TAVR on more adverse outcomes in TTRCA-AS patients compared to those with AS alone is still uncertain, with conflicting findings reported in the literature.
PubMed and Scopus were extensively searched from inception till August 2021. Studies were included if they reported data for prevalence and outcomes including mortality and cardiovascular-related hospitalization events in TTRCA-AS patients referred for TAVR. The data for these outcomes were pooled using a random effects model and forest plots were created.
After initially screening 146 articles, 6 were shortlisted for inclusion in our analysis. Pooled analysis demonstrated a 13.3% [95% CI: 10.9–16.5; p = 0.307] prevalence of TTRCA in patients with AS undergoing TAVR. The incidence of mortality and cardiovascular (CV) hospitalization in patients with TTRCA-AS undergoing TAVR were 28.3% [95% CI: 18.7–39.0, p = 0.478] and 21.1% [95% CI: 10.2–34.5, p = 0.211], respectively.
The overall pooled TTRCA-AS prevalence was reported to be 13.3% in AS patients who underwent TAVR. Furthermore, transthyretin-associated CA was found to be associated with an increased risk of mortality and hospitalization. Large patient population studies are required to assess the safety and efficacy of TAVR in TTRCA-AS patients, as current research report data from small patient cohorts.
2024 ACC/AHA Clinical Performance and Quality Measures for Adults With Valvular and Structural Heart Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Performance Measures
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Sex-Specific Disparities in Clinical Outcomes After Transcatheter Aortic Valve Replacement Among Different Racial Populations
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Sex-related disparities in clinical outcomes following transcatheter aortic valve replacement (TAVR) and the impact of sex on clinical outcomes after TAVR among different racial groups are undetermined.
This study assessed whether sex-specific differences in baseline clinical and anatomical characteristics affect clinical outcomes after TAVR and investigated the impact of sex on clinical outcomes among different racial groups.
The TP-TAVR (Trans-Pacific TAVR) registry is a multinational cohort study of patients with severe aortic stenosis who underwent TAVR at 2 major centers in the United States and 1 major center in South Korea. The primary outcome was a composite of death from any cause, stroke, or rehospitalization after 1 year.
The incidence of the primary composite outcome was not significantly different between sexes (27.9% in men vs 28% in women; adjusted HR: 0.97; 95% CI: 0.79-1.20). This pattern was consistent in Asian (23.5% vs 23.3%; adjusted HR: 0.99; 95% CI: 0.69-1.41) and non-Asian (30.8% vs 31.6%; adjusted HR: 0.95; 95% CI: 0.72-1.24) cohorts, without a significant interaction between sex and racial group (P for interaction = 0.74). The adjusted risk for all-cause mortality was similar between sexes, regardless of racial group. However, the adjusted risk of stroke was significantly lower in male patients than in female patients, which was more prominent in the non-Asian cohort.
Despite significantly different baseline and procedural characteristics, there were no sex-specific differences in the adjusted 1-year rates of primary composite outcomes and all-cause mortality, regardless of different racial groups. (Transpacific TAVR registry [TP-TAVR]; NCT03826264)
Impact of carotid artery stenosis on outcomes of transcatheter aortic valve replacement: A systematic review and meta-analysis
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Carotid Artery Stenosis (CAS) is common in elderly patients undergoing Transcatheter Aortic Valve Replacement (TAVR). However, the impact of CAS on the outcomes of TAVR is unclear.
This systematic review and meta-analysis aimed to compare the clinical and periprocedural outcomes in patients with and without CAS undergoing TAVR.
PubMed, Embase, and Cochrane databases were searched until February 2023. We included studies that performed a direct comparison of outcomes of TAVR in CAS versus non-CAS patients. Data was extracted from published reports and the ROBINS-I tool was utilized for quality assessment. The R studio software (version 4.2.2) was adopted for statistical analysis.
Five observational studies and 111.915 patients were included. The mean age was 80.7 ± 8.2 years and 46.3% were female. The risk of stroke or transient ischemic attack was elevated in the group of patients with CAS (OR 1.44; 95% CI 1.07–1.95; p = 0.016). In contrast, myocardial infarction (OR 1.24; 95% CI 1.05–1.47; p = 0.074) and all-cause mortality (OR 0.99; 95% CI 0.73–1.35; p = 0.95) were not significantly different between CAS and non-CAS groups. Acute kidney injury and new pacemaker implantation did not differ between patients with and without CAS.
Our findings suggest that CAS is significantly associated with cerebrovascular events in patients undergoing TAVR, without significantly impacting all-cause mortality. Further prospective studies are needed for a more granular assessment of additional determinants of this association, such as unilateral vs. bilateral involvement and whether there is a threshold of CAS severity for increased risk.

View all citing articles on Scopus

^†: M J Davidson died in January, 2015

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Articles5-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

Summary

Background

Methods

Findings

Interpretation

Funding

Introduction

Section snippets

Study design and participants

Results

Discussion

J Am Coll Cardiol

JACC Cardiovasc Interv

Am J Cardiol

JACC Cardiovasc Interv

J Am Coll Cardiol

Ann Thorac Surg

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

J Thorac Cardiovasc Surg

JACC Cardiovasc Interv

J Am Coll Cardiol

Registry of transcatheter aortic-valve implantation in high risk patients

N Engl J Med

Articles
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