Complications After Self-expanding Transcatheter or Surgical Aortic Valve Replacement.

Procedural complications following transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) are usually reported as retrospective analyses. We report the first comparison of complications following SAVR or self-expanding TAVR from a prospectively randomized study of high-risk SAVR patients. Three hundred ninety-five TAVR and 402 SAVR patients were prospectively enrolled and randomized 1:1 to TAVR with a CoreValve bioprosthesis or a surgical bioprosthetic valve. The rates of major procedural and vascular complications occurring (periprocedurally (0-3 days) and early (4-30 days)) were compared for TAVR vs SAVR patients. All-cause mortality, stroke, myocardial infarction, and major infection were similar in both periods post procedure. Within 0-3 days, the major vascular complication rate was significantly higher with TAVR (P = 0.003). Life-threatening or disabling bleeding (P < 0.001), encephalopathy (P = 0.02), atrial fibrillation (P < 0.001), and acute kidney injury (P < 0.001) were significantly higher with SAVR. Non-iliofemoral TAVR approaches had a higher incidence of major or life-threatening or disabling bleeding at 0-3days (P < 0.05). Procedural complications unique to TAVR included coronary occlusion 0.5% (2) and TAVR pop outs 2.8% (11) with no valve embolizations. Pop outs were similar between iliofemoral 2.8% (9/324) and non-iliofemoral approaches 3.0% (2/66). Procedural complications unique to SAVR included aortic dissection 0.8% (3/357) and injury to other heart structures 2.0% (7/357). The procedural complication profiles of TAVR and SAVR are unique. Intraoperative deaths were seen in TAVR only. Mortality at 3 and 30 days was similar. The higher incidence of some complications likely reflects the greater invasiveness of SAVR in this aged high-risk population.

Conte JV ，Hermiller J Jr ，Resar JR ，Deeb GM ，Gleason TG ，Adams DH ，Popma JJ ，Yakubov SJ ，Watson D ，Guo J ，Zorn GL 3rd ，Reardon MJ ... -  《-》

Self-Expanding Transcatheter Aortic Valve Replacement Versus Surgical Valve Replacement in Patients at High Risk for Surgery: A Study of Echocardiographic Change and Risk Prediction.

The CoreValve US High-Risk Clinical Study compared clinical outcomes and serial echocardiographic findings in patients with severe aortic valve stenosis after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis or surgical aortic valve replacement (SAVR). Eligible patients were randomly assigned 1:1 to TAVR with a self-expanding bioprosthesis or SAVR (N=747). Echocardiograms were obtained at baseline, discharge, 30 days, 6 months, and 1 year after the procedure and were analyzed at a central core laboratory. Compared with SAVR patients (N=357), TAVR patients (N=390) had a lower mean aortic valve gradient, larger valve area, and less patient-prosthesis mismatch (all P<0.001), but more paravalvular regurgitation at discharge, which decreased at 1 year. SAVR patients experienced significant right ventricular systolic dysfunction at discharge and 1 month with normal right ventricular function at 1 year. One-year all-cause mortality was 14.2% for TAVR and 19.1% for SAVR patients. Preimplantation aortic regurgitation ≥mild was associated with reduced mortality hazard for both the TAVR (hazard ratio 0.48, 95% confidence interval 0.27-0.85; P=0.01) and the SAVR groups (hazard ratio 0.53, 95% confidence interval 0.32-0.87; P=0.01). Aortic regurgitation ≥mild after TAVR was associated with increased risk for all-cause mortality (hazard ratio 1.95, 95% confidence interval 1.08-3.53; P=0.03). In patients with severe aortic stenosis at increased surgical risk, TAVR was associated with better systolic valve performance, similar left ventricular remodeling, more paravalvular regurgitation, and less right ventricular systolic dysfunction compared with SAVR. Despite an overall mortality reduction for the TAVR group, ≥mild aortic valve regurgitation after TAVR was associated with an increased mortality hazard. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01240902.

Little SH ，Oh JK ，Gillam L ，Sengupta PP ，Orsinelli DA ，Cavalcante JL ，Chang JD ，Adams DH ，Zorn GL 3rd ，Pollak AW ，Abdelmoneim SS ，Reardon MJ ，Qiao H ，Popma JJ ... -  《-》

Prosthesis-patient mismatch in high-risk patients with severe aortic stenosis: A randomized trial of a self-expanding prosthesis.

We compared the incidence of prosthesis-patient mismatch (PPM) between transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis and surgical aortic valve replacement (SAVR) in the CoreValve US High Risk Pivotal Trial. We sought to determine the influence of PPM on clinical outcomes. Patients with severe aortic stenosis and at increased risk for surgery were randomized 1:1 to TAVR or SAVR. Postoperative PPM was defined by the effective orifice area index (EOAi) as severe PPM (EOAi ≤ 0.65 cm(2)/m(2)) and no severe PPM (EOAi > 0.65 cm(2)/m(2)); clinical outcomes were analyzed in the TAVR arm (n = 389) and SAVR arm (n = 353). Left ventricular mass index and regression were analyzed at baseline and 1 year. The incidence of severe PPM in the SAVR group at 1 year was 25.7% versus 6.2% in the TAVR group (P < .0001). Left ventricular mass index regression at 1 year was 6.8% for TAVR and 15.1% for SAVR in patients with severe PPM. At 1 year the rate of all-cause mortality and acute kidney injury were significantly greater in all patients (TAVR + SAVR) with severe PPM compared with no severe PPM (20.6% vs 12.0% [P = .0145] for death and 19.2% vs 8.5% [P = .0008] for acute kidney injury). In patients with high surgical risk and severe aortic stenosis, severe PPM is more common in patients treated with SAVR than those treated with TAVR. Patients with severe PPM are a greater risk for death and acute kidney injury than patients without severe PPM.

Zorn GL 3rd ，Little SH ，Tadros P ，Deeb GM ，Gleason TG ，Heiser J ，Kleiman NS ，Oh JK ，Popma JJ ，Adams D ，Huang J ，Reardon MJ ... -  《-》

Two-Year Outcomes in Patients With Severe Aortic Valve Stenosis Randomized to Transcatheter Versus Surgical Aortic Valve Replacement: The All-Comers Nordic Aortic Valve Intervention Randomized Clinical Trial.

The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize all-comers with severe native aortic valve stenosis to either transcatheter aortic valve replacement (TAVR) with the CoreValve self-expanding bioprosthesis or surgical aortic valve replacement (SAVR), including a lower-risk patient population than previous trials. This article reports 2-year clinical and echocardiographic outcomes from the NOTION trial. Two-hundred eighty patients from 3 centers in Denmark and Sweden were randomized to either TAVR (n=145) or SAVR (n=135) with follow-up planned for 5 years. There was no difference in all-cause mortality at 2 years between TAVR and SAVR (8.0% versus 9.8%, respectively; P=0.54) or cardiovascular mortality (6.5% versus 9.1%; P=0.40). The composite outcome of all-cause mortality, stroke, or myocardial infarction was also similar (15.8% versus 18.8%, P=0.43). Forward-flow hemodynamics were improved following both procedures, with effective orifice area significantly more improved after TAVR than SAVR (effective orifice area, 1.7 versus 1.4 cm(2) at 3 months). Mean valve gradients were similar after TAVR and SAVR. When patients were categorized according to Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) (<4% versus ≥4%), there was no statistically significant difference for TAVR and SAVR groups in the composite outcome for low-risk (14.7%, 95% confidence interval, 8.3-21.2 versus 16.8%; 95% confidence interval, 9.7-23.8; P=0.58) or intermediate-risk patients (21.1% versus 27.1%; P=0.59). Two-year results from the NOTION trial demonstrate the continuing safety and effectiveness of TAVR in lower-risk patients. Longer-term data are needed to verify the durability of this procedure in this patient population. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01057173.

Søndergaard L ，Steinbrüchel DA ，Ihlemann N ，Nissen H ，Kjeldsen BJ ，Petursson P ，Ngo AT ，Olsen NT ，Chang Y ，Franzen OW ，Engstrøm T ，Clemmensen P ，Olsen PS ，Thyregod HG ... -  《-》

In-hospital outcomes of transcatheter versus surgical aortic valve replacement in non-teaching hospitals.

To assess the in-hospital outcomes of transcatheter aortic valve replacement (TAVR) vs. surgical aortic valve replacement (SAVR) in non-teaching hospitals. TAVR has become widely available in the United States. However, the comparative outcomes of TAVR vs. SAVR in non-teaching hospitals are largely under explored. We queried the Nationwide Inpatient Sample database from 2011 to September 2015 to identify those who were 50 years or above and underwent either trans-arterial TAVR or SAVR at non-teaching hospital. In-hospital clinical outcomes were compared with odds ratio (OR) in propensity-matched cohorts. We identified un-weighted 957 and 7,465 SAVR admissions. In propensity-matched model, 596 admissions in each arm were included for final analysis. In-patient mortality (3.9 vs. 2.5%, OR 1.54, P = 0.34), acute kidney injury requiring dialysis (2.2 vs. 2.7%, OR 0.80, P = 0.57), stroke (2.0 vs. 3.2%, OR 0.61, P = 0.20), and pacemaker placement (8.9 vs. 6.4%, OR 1.47, P = 0.09) was similar between TAVR and SAVR. Sub-group analysis showed that female and those with prior coronary artery bypass surgery had higher risk of in-patient morality in TAVR admission. Cost was higher (59,103 vs. 53,411 dollars, P = 0.006) but length of stay was shorter in TAVR (6.9 vs. 10.2 days, P < 0.001). TAVR conferred similar in-hospital mortality and major peri-procedural complications compared with SAVR in non-teaching hospitals. For those with limited access to teaching hospitals, non-teaching hospitals appear to be a reasonable option for candidates of aortic valve replacement for severe aortic stenosis.

Ando T ，Adegbala O ，Villablanca PA ，Briasoulis A ，Takagi H ，Grines CL ，Schreiber T ，Nazif T ，Kodali S ，Afonso L ... -  《-》