Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled in the SAVI TF registry

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ObjectivesTo evaluate 1‐year outcome using the ACURATE neo (Symetis S.A., a Boston Scientific Company, Ecublens, Switzerland) according to the updated Valve Academic Research Consortium (VARC‐2) with emphasis on the composite endpoints “clinical efficacy after 30 days” and “time‐related valve safety”.BackgroundInitial reports on the clinical performance of patients treated with the ACURATE neo are promising; however, information regarding one‐year outcome is scarce, especially with regard to the composite endpoints proposed by the VARC‐2.MethodsOne hundred and fifty one consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) with the ACURATE neo for severe aortic valve stenosis were enrolled. Data were prospectively collected and event rates during follow‐up were calculated as the Kaplan–Meier estimates.ResultsMean age was 81.1 ± 5.9 years and 49.7% (75/151) were female with a median logistic EuroScore of 13.8% [8.2–20.5]. Device success was achieved in 88.1% (133/151) and procedure related mortality was 0.7% (1/151). At one‐year, all‐cause mortality was 3.3% (5/151), while permanent pacemaker implantation occurred in 12.7% (19/151) of patients. The “clinical efficacy after 30 days” was observed in 24.8% (37/151), where the main contributor was symptom worsening in 14.8% (22/151) of cases. “Time‐related valve safety” occurred in 22.0% (33/151) with structural valve deterioration as main contributor in 10.7% (16/151) of cases.ConclusionsUsing the ACURATE neo, we found a favorable safety profile with low all‐cause mortality at 1 year. The reported VARC‐2 defined composite endpoints at 1 year reveal low rates of “clinical efficacy after 30 days” and “time‐related valve safety”.

Section: Discussioncontrasting

confidence: 71%

Section: Discussioncontrasting

confidence: 66%

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One‐year clinical outcome with a novel self‐expanding transcatheter heart valve

Pellegrini

Rheude

Trenkwalder

et al. 2019

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“…To date, different studies and registries reported excellent early outcomes of TAVI using next‐generation devices . In a recent meta‐analysis, we reported a marked reduction in all‐cause and cardiovascular death (from 7.8 and 2.2% to 4.1 and 1.6%, respectively), life‐threatening bleeding, and major vascular complications (from 15.6 and 11.9 to 3.9 and 4.5%, respectively) as well as in disabling stroke rate (from 3.2 to 0.9%) of TAVI using new‐generation devices compared to first generation devices .…”

Section: Discussionmentioning

confidence: 87%

Outcomes of three different new generation transcatheter aortic valve prostheses

Costa

Buccheri

Barbanti

et al. 2019

Aims To evaluate outcomes of transfemoral transcatheter aortic valve implantation (TF‐TAVI) using three different new‐generation devices. Background Although new generation transcatheter aortic valves (TAVs) have demonstrated to improve procedural outcomes, to date few head‐to‐head comparisons are available among these devices. Methods This is a single center, retrospective study. From September 2014 to February 2018, 389 patients underwent elective TF‐TAVI for native, severe aortic stenosis using a new‐generation transcatheter aortic valve (TAV) with a preprocedural multi‐detector computed tomography assessment. Among these, 346 patients received an Edwards SAPIEN 3 (n = 134), Medtronic Evolut R (n = 111), or Boston ACURATE neo (n = 101) prosthesis. Differences in baseline clinical characteristics between groups were accounted using the propensity score weighting method. RESULTS The mean age for the entire study cohort was 81.4 ± 5.2 years while the Society of Thoracic Surgery predicted risk of mortality was 4.0 ± 2.5%. After propensity score weighting adjustment, TAVs did not differently impact on 30‐day all‐cause and cardiovascular mortality. Evolut R device showed an increased risk of permanent pacemaker implantation (PPI) after the procedure (8.3% for SAPIEN 3 vs. 16.7% for Evolut R vs. 2.1% for ACURATE neo, p < .05). At 30 days, patients treated with SAPIEN 3 valve showed a higher mean transvalvular gradient (9.7 ± 7.5 mmHg vs. 6.1 ± 2.4 mmHg vs. 8.4 ± 3.5 mmHg for SAPIEN 3, Evolut R, and ACURATE neo, respectively, p < .01) and a lower rate of more‐than‐trace paravalvular regurgitation (PVR) (18.8 vs. 47.9 vs. 45.8%, for SAPIEN 3, Evolut R, and ACURATE neo, respectively, p < .01). At 1 year, SAPIEN 3, Evolut R, and ACURATE neo TAVs showed excellent and comparable outcomes with no difference in terms of freedom from major adverse cardiovascular and cerebrovascular event (MACCE) (plog‐rank = 0.534). Conclusions TAVI using new‐generation prostheses was associated with high device success (97.0% vs. 92.8% vs. 95.0% for SAPIEN 3, Evolut R and ACURATE neo, respectively) and low complications rates up to 1 year. Evolut R valve was associated with a higher rate of PPI whereas SAPIEN 3 valve was associated with a higher mean transvalvular gradient and lower rate of more‐than‐trace PVR. At 1‐year, MACCE rates were similar among the three groups.

“…These favorable results for survival, stroke and PPI with this novel THV were also demonstrated in the subsequent 1,000 patients SAVI‐TF multicenter registry of ACURATE neo in intermediate and high risk patients which at 1 year showed low all‐cause mortality at 8%, one of the lowest reported PPI rates at 9.9% (possibly related to low radial force and minimal protrusion of the lower crowns into left ventricular outflow tract of this THV thereby decreasing compression of the conduction system) and very low rates of moderate to severe PVL at 3.5% …”

mentioning

confidence: 52%

A novel self‐expanding transcatheter heart valve: Shaping the story beyond accuracy

Seth

Kumar

2019

Key Points As transcatheter aortic valve implantation expands to low risk patients, the key to prolonged survival would be large effective orifice area with extremely low rates of paravalvular leak and permanent pacemaker implantation. New transcatheter valve technologies look promising to enable this, ACURATE neo is one such device. The results of ongoing trials with ACURATE neo and ACURATE neo2 are keenly awaited.