Transcatheter vs surgical aortic valve replacement in intermediate-surgical-risk patients with aortic stenosis: A propensity score–matched case-control study

Latib, Azeem; Maisano, Francesco; Bertoldi, Letizia; Giacomini, Andrea; Shannon, Joanne; Cioni, Micaela; Ielasi, Alfonso; Figini, Filippo; Tagaki, Kensuke; Franco, Annalisa; Covello, Remo Daniel; Grimaldi, Antonio; Spagnolo, Pietro; Buchannan, Gill Louise; Carlino, Mauro; Chieffo, Alaide; Montorfano, Matteo; Alfieri, Ottavio; Colombo, Antonio

doi:10.1016/j.ahj.2012.09.005

Cited by 101 publications

(53 citation statements)

References 25 publications

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“…Although SAVR currently remains the standard of care for the intermediate to low surgical risk population, several independent studies conducted predominantly in Europe have compared TAVR to SAVR in this population and demonstrated promising results for TAVR. The influx of data on outcomes from TAVR in the intermediate risk population continues to increase (6)(7)(8)(9)(10)(11)(12)(13)(14). For example, the ongoing SURTAVI and PARTNER II trials are investigating the safety and efficacy of TAVR compared to SAVR in an intermediate risk population.…”

Section: Introductionmentioning

confidence: 99%

Transcatheter versus surgical aortic valve replacement in intermediate risk patients: a meta-analysis

Arora

Misenheimer

Jones

et al. 2016

Cardiovasc. Diagn. Ther.

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Background: Transcatheter aortic valve replacement (TAVR) has been approved in patients with high or prohibited surgical risk for surgery for treatment of severe symptomatic aortic stenosis. Prospective studies examining the benefits of TAVR in intermediate risk patients are ongoing. Other smaller studies including lower risk patients have been conducted, but further meta-analysis of these studies is required to draw more broad comparisons.Methods: A Medline search was conducted using standard methodology to search for clinical trials and observational studies including intermediate risk patients. We limited our meta-analysis to studies matching patient populations by propensity scores or randomization and examined clinical outcomes between TAVR and surgical aortic valve replacement (SAVR). Conclusions: We conclude that in intermediate risk patients undergoing aortic valve replacement, the risk of mortality, neurological outcomes, and MI do not appear to be significantly different between TAVR and SAVR. However, there appears to be a significant reduction in risk of acute renal failure at the expense of an increased risk of requiring a permanent pacemaker in low and intermediate risk patients undergoing TAVR compared to SAVR.

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Section: Introductionmentioning

confidence: 99%

Transcatheter versus surgical aortic valve replacement in intermediate risk patients: a meta-analysis

Arora

Misenheimer

Jones

et al. 2016

Cardiovasc. Diagn. Ther.

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“…[7][8][9] Recently, increased operator experience and enhanced transcatheter valve systems have led to a worldwide trend to use TAVR in patients who are at low or intermediate risk. [10][11][12] This trend has been evaluated in small observational studies, [13][14][15][16][17] but since most patients who are currently recommended for surgery are at low or intermediate risk, 5,6,18 the expansion of the use of TAVR mandates rigorous clinical-trial validation. We report the results from the Placement of Aortic Transcatheter Valves (PARTNER) 2 cohort A randomized trial, in which TAVR with a second-generation valve system was compared with conventional surgery in patients with severe aortic stenosis and intermediate-risk clinical profiles.…”

mentioning

confidence: 99%

Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients

et al. 2016

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BACKGROUNDPrevious trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aorticvalve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients. METHODSWe randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort. RESULTSThe rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P = 0.001 for noninferiority). At 2 years, the Kaplan-Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P = 0.25). In the transfemoralaccess cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P = 0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation. CONCLUSIONSIn intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.) a bs tr ac t

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“…Table 3 summarizes the results of 3 studies where intermediate-to low-risk patients treated with TAVI were propensity-score matched with SAVR-treated counterparts. 14,123,124 Mortality, stroke, and myocardial infarction at 30-day and mortality at 1 year were comparable after both treatment strategies. However, important differences exist in other outcome measures.…”

Section: Other Observational Datamentioning

confidence: 76%

“…However, important differences exist in other outcome measures. Major bleeding 123,124 (1.5-fold) and acute kidney injury 124 (1.8-fold) were more common after SAVR while major vascular injury 123,124 (5-to 14-fold), permanent pacemaker implantation 123,124 (4-to 15-fold) and AR 123,124 (mild: ≤21-fold, moderate to severe: 2-to 3-fold) were more common after TAVI.…”

Section: Other Observational Datamentioning

confidence: 99%

Transcatheter Aortic Valve Implantation in Lower-Risk Patients With Aortic Stenosis

Abdelghani

Serruys

2016

Circ: Cardiovascular Interventions

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Abstract-Transcatheter aortic valve implantation underwent progressive improvements until it became the default therapy for inoperable patients, and a recommended therapy in high-risk operable patients with symptomatic severe aortic stenosis. In the lower-risk patient strata, a currently costly therapy that still has important complications with questionable durability is competing with the established effective and still-improving surgical replacement. This report tries to weigh the clinical evidence, the recent technical improvements, the durability, and the cost-effectiveness claims supporting the adoption of transcatheter aortic valve implantation in intermediate-low risk patients. The importance of appropriate patients' risk stratification and a more comprehensive approach to estimate that risk are also emphasized in the present report. (Circ Cardiovasc Interv. 2016;9:e002944.

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Transcatheter vs surgical aortic valve replacement in intermediate-surgical-risk patients with aortic stenosis: A propensity score–matched case-control study

Cited by 101 publications

References 25 publications

Transcatheter versus surgical aortic valve replacement in intermediate risk patients: a meta-analysis

Transcatheter versus surgical aortic valve replacement in intermediate risk patients: a meta-analysis

Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients

Transcatheter Aortic Valve Implantation in Lower-Risk Patients With Aortic Stenosis

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