Standardized Minimalistic Transfemoral Transcatheter Aortic Valve Replacement (TAVR) Using the SAPIEN 3 Device: Stepwise Description, Feasibility, and Safety from a Large Consecutive Single-Center Single-Operator Cohort

<p><b>Background:</b> To describe our updated minimalist approach (MA) for transfemoral transcatheter aortic valve replacement (TF-TAVR) using the SAPIEN 3 device and its evolution, as well as associated safety and efficacy parameters from a large cohort of patients.</p> <p><b>Methods:</b> A stepwise description of the MA technique for TAVR for 300 consecutive patients was detailed. Safety and efficacy parameters were assessed using the VARC-2 criteria at the in-hospital and 30-days follow-up.</p> <p><b>Results:</b> A total of 300 consecutive patients (80 ± 7 years; median Logistic EuroSCORE of 11.4% [7.5–17.8]) between January 2014 and May 2016 were evaluated. TF-TAVR was performed under conscious sedation in 247 (82%) patients. Device success was achieved in 286 (95.6%) patients, and intended prosthesis performance in 289 (96.3%) patients. Significant paravalvular leak (PVL) graded more than mild was noted in 7 (2%) patients. No patient had severe PVL. All-cause mortality was noted in one (0.3%) patient in-hospital and in 2 (0.7%) patients at the 30-days follow-up. Major stroke occurred in 4 (1.3%) patients. 9 (3%) patients had major vascular complications at 30-days follow up. MACCE (VARC-2 criteria) were observed in 21 (7%) in-hospital and 25 (8.3%) at 30 days. A new permanent pacemaker implantation was required in 29 (10.7%) patients, and was reduced from 18% to 5.6% (<i>p</i> = 0.001) in a subgroup analysis considering higher implantation position of the valve after the first year of experience.</p> <p><b>Conclusion:</b> MA of TF-TAVR, when simplified and standardized, is reproducible, safe and efficient, and should be encouraged to be accepted as the standard method of care.</p

Characteristics of 25 patients with isolated cardiac device pocket infection and 50 control patients.

<p>Characteristics of 25 patients with isolated cardiac device pocket infection and 50 control patients.</p

Receiver operator characteristic curve (ROC)-Analysis for the relevant biomarkers.

<p>Receiver operator characteristic curve (ROC)-Analysis for the relevant biomarkers.</p

Selection and description of the 14 analysed biomarkers.

<p>Selection and description of the 14 analysed biomarkers.</p

Comparison of biomarker levels between infected and control groups using established cut-offs.

<p>Comparison of biomarker levels between infected and control groups using established cut-offs.</p

Study flow chart.

<p>Study flow chart.</p

General diagnostic work up and identification of patients with an isolated pocket infection.

<p>General diagnostic work up and identification of patients with an isolated pocket infection.</p

Comparison of biomarker levels between infected and control groups using absolute concentration.

<p>Comparison of biomarker levels between infected and control groups using absolute concentration.</p

Comparison of sensitivity and specificity for relevant biomarkers applying established or optimized cut-off values.

<p>Comparison of sensitivity and specificity for relevant biomarkers applying established or optimized cut-off values.</p

Characteristics of 25 patients with isolated cardiac device pocket infection and 50 control patients.

<p>Characteristics of 25 patients with isolated cardiac device pocket infection and 50 control patients.</p