Safety and efficacy of hybrid vascular closure technique using both a suture- and collagen-mediated closure device after transfemoral transcatheter aortic valve implantation.

OBJECTIVES: To evaluate the clinical utility and feasibility of a hybrid technique for obtaining vascular hemostasis by combining a suture- and a collagen-mediated system after transfemoral transcatheter aortic valve implantation (TF TAVI) in a real-world setting. METHODS: In 75 consecutive TF TAVI procedures, we investigated a hybrid closing method to achieve hemostasis at the large bore puncture site using a combination of one presuture closure system (ProGlide) and one collagen-mediated system (Angio-Seal). Vascular complications at puncture site were recorded until discharge. RESULTS: Successful hemostasis by the hybrid technique was achieved in 74 out of 75 patients, and the method was well tolerated by all patients. In 73 patients, (97.3%) neither puncture site related complications nor serious early or late bleedings were observed during a median hospital stay of 2 days postprocedure. CONCLUSION: This single-center registry study indicates that a percutaneous hybrid closure technique is safe and efficacious in closing large bore arteriotomies. It is an easy and reliable technique that may contribute to simplifying TAVI procedures. STUDY REGISTRATION: The data was collected from an internal quality control registry on treatment of patients with valvular heart disease with or without coronary artery disease, No 2014/17280, Oslo University Hospital, Ullevål.

TAVR outcome after reclassification of aortic valve stenosis by using a hybrid continuity equation that combines computed tomography and echocardiography data.

BACKGROUND: In the continuity equation, assumption of a round-shaped left ventricular outflow tract (LVOT) leads to underestimation of the true aortic valve area in two-dimensional echocardiography. The current study evaluated whether inclusion of the LVOT area, as measured by computed tomography (CT), reclassifies the degree of aortic stenosis (AS) and assessed the impact on patient outcome after transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: Four hundred and twenty-two patients with indexed aortic valve area index (AVAi) of <0.6 cm2 /m2 , assessed by using the classical continuity equation (mean age: 81.5 ± 6.1 years, 51% female, mean left ventricular ejection fraction: 53.2 ± 13.6%), underwent TAVR and were included. After inclusion of the CT measured LVOT area into the continuity equation, the hybrid AVAi led to a reclassification of 30% (n = 128) of patients from severe to moderate AS. Multivariate predictors for reclassification were male sex, lower mean aortic gradient, and lower annulus/LVOT ratio (all p < .01). Reclassified patients had significantly higher sST2 at baseline and higher NT-proBNP values at baseline and 6 months follow-up compared to non-reclassified patients. Acute kidney injury was experienced more frequently after TAVR by reclassified patients, but no significant mortality difference occurred during 2 years of follow-up. CONCLUSION: The hybrid AVAi reclassifies a significant portion of low-gradient severe AS patients into moderate AS. Reclassified patients showed increased fibrosis and heart failure markers at baseline compared to non-reclassified patients. But reclassification had no significant impact on mortality up to 2 years after TAVR. Routine assessment of hybrid AVAi seems not to improve further risk stratification of TAVR patients.

Outcomes of three different new generation transcatheter aortic valve prostheses.

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.

Resource utilization for transfemoral transcatheter aortic valve replacement: An international comparison.

BACKGROUND: Transfemoral transcatheter aortic valve replacement (TF-TAVR) has enjoyed a rapid diffusion in the US and Europe, but the procedure is resource intensive. OBJECTIVES: We sought to identify differences in resource utilization between a US and European center to ascertain opportunities for improvement in the performance of TF-TAVR. METHODS: All patients undergoing TF-TAVR using the Edwards SAPIEN valve series at the San Raffaele Hospital (Milan, Italy) and the Cleveland Clinic Foundation (Cleveland, OH) between January 2011 and December 2012 were included. Resource utilization was defined as preprocedural imaging, intraprocedural imaging, and personnel present during the procedure. RESULTS: A total of 158 patients from Cleveland and 113 from Milan were analyzed. Median logistic EuroScore (22.1 vs. 15.5, P = 0.013) and STS-PROM (8.9 vs. 5.0%, P < 0.001) were higher in Cleveland. Thirty-day outcomes were similar. Majority of procedures in Milan were conducted without a cardiac surgeon (79%) or an imaging specialist (99%) present during the case. There was greater reliance on endotracheal intubation (94.3 vs. 3.5%), general anesthesia (GA: 94.3 vs. 4.4%), and intraprocedural TEE (93 vs. 12.4%) in Cleveland, but shorter length of stay (mean: 6.42 vs. 11.16 days). CONCLUSIONS: We characterized resources used for patients undergoing TF-TAVR in Cleveland and Milan. Important differences included less reliance on GA and TEE and streamlining of procedural personnel in Milan, and reduced length-of-stay in Cleveland. Evolution of TF-TAVR to involve fewer operators must be balanced with the need for ready access to a comprehensive group of specialists in case of emergencies. © 2015 Wiley Periodicals, Inc.