Transcatheter Aortic Valve Implantation Compared With Surgical Aortic Valve Replacement in Low-Risk Patients

Abstract

Background-The proven efficacy of transcatheter aortic valve implantation (TAVI) in high-risk patients is leading to the expansion of its indications toward lower-risk patients. However, this shift is not supported by meaningful evidence of its benefit over surgical aortic valve replacement (SAVR). This analysis aims to describe outcomes of TAVI versus SAVR in low-risk patients. Methods and Results-We compared the outcome after TAVI and SAVR of low-risk patients (European System for CardiacOperative Risk Evaluation II [EuroSCORE II] <4%) included in the Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment (OBSERVANT) study. The primary outcome was 3-year survival. Secondary outcomes were early events and major adverse cardiac and cerebrovascular events at 3 years. Propensity score matching resulted in 355 pairs of patients with similar baseline characteristics. Thirty-day survival was 97.1% after SAVR and 97.4% after TAVI (P=0.82). Cardiac tamponade, permanent pacemaker implantation, major vascular damage, and moderate-to-severe paravalvular regurgitation were significantly more frequent after TAVI compared with SAVR. Stroke rates were equal in the study groups. SAVR was associated with higher risk of cardiogenic shock, severe bleeding, and acute kidney injury. At 3 years, survival was 83.4% after SAVR and 72.0% after TAVI (P=0.0015), whereas freedom from major adverse cardiac and cerebrovascular events was 80.9% after SAVR and 67.3% after TAVI (P<0.001). Conclusions-In patients with low operative risk, significantly better 3-year survival and freedom from major adverse cardiac and cerebrovascular events were observed after SAVR compared with TAVI. Further studies on new-generation valve prostheses are necessary before expanding indications of TAVI toward lower-risk patients. The aim of the present study is to evaluate the early and 3-year outcome after TAVI and SAVR in low-risk patients (EuroSCORE II <4%) from the multicenter nationwide prospective Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment (OBSERVANT) study. Methods Study Design and Data CollectionOBSERVANT is a national observational, prospective, multicenter, cohort study that enrolled consecutive patients undergoing TAVI or SAVR for severe aortic valve stenosis at 93 Italian cardiology/cardiac surgery centers between December 2010 and June 2012. Details on the study design, patient eligibility criteria, and data collection modalities have been reported elsewhere.9 This study was coordinated by the Italian National Institute of Health and led in cooperation with the Italian Ministry of Health, the National Agency for Regional Health Services, Italian Regions, and Italian scientific societies and federations representing Italian professionals involved in the management of aortic valve stenosis. The complete list of executive working group, participating centers, and investigators is reported in the Appendix in the Data Supplement. In the participating hospital...

Transcatheter Aortic Valve Replacement in Low-Risk Patients Within the Observational Study of Effectiveness of SAVR–TAVI Procedures for Severe Aortic Stenosis Treatment Study

“…As Rosato et al 12 intimate in their conclusions, there are currently insufficient data to justify an expansion of TAVR to low-risk subgroups. Although their findings would suggest that such patients fare worse with TAVR than SAVR in terms of both mid-and longterm outcomes (ie, survival and major adverse cardiovascular and cerebral events), their mortality rates after TAVR seem disproportionately high compared with other recent studies, especially in light of the low-risk study population.…”

“…The study also demonstrated that rates of stroke (4.6%) and moderate or severe aortic regurgitation (1.5%) had improved with the Sapien 3 device relative to the Sapien XT. 12 The OBSERVANT study is a large prospective observational cohort that enrolled patients undergoing transcatheter and surgical AVR at 93 Italian centers for an 18-month time period and coordinated by the Italian National Institute of Health. The original aim of OBSERVANT was to characterize the comparative effectiveness between these treatment modalities in a real-world setting.…”

Medium and long-term prognosis of transcatheter aortic valve implantation from the perspective of left ventricular diastolic function

“…Patient background, clinical findings and blood test results were retrieved from electronic medical records (EMRs) and anesthesia charts. Data were collected for age, gender, European System for Cardiac Operative Risk Evaluation II (Euro II) score [5], Logistic Euro (LogEuro) score, Society of Thoracic Surgery (STS) score [6], albumin level [7], renal function based on estimated glomerular filtration rate (eGFR), hypertension, diabetes, dyslipidemia, coronary artery disease(CAD) and percutaneous coronary intervention (PCI), chronic obstructive pulmonary disease (COPD), and New York Heart Association (NYHA) classification.…”

Rapid Deployment Aortic Replacement (RADAR) Registry in Spain: a protocol

“…Results from the PARTNERS II trial conclude that in intermediate-risk patients, TAVI was similar to surgical AVR with respect to the primary end point of death or disabling stroke 15. Rosato et al 16 have recently reported in patients with low operative risk a significantly better 3-year survival and freedom from major cardiac and cerebrovascular in patients undergoing surgical AVR compared with TAVI. In addition, controversy exists on the cost-effectiveness of TAVI 17.…”