Upper extremity versus lower extremity for secondary access during transcatheter aortic valve implantation: rationale and design of the randomised TAVI XS trial.

BACKGROUND: During transcatheter aortic valve implantation (TAVI), secondary access is required for angiographic guidance and temporary pacing. The most commonly used secondary access sites are the femoral artery (angiographic guidance) and the femoral vein (temporary pacing). An upper extremity approach using the radial artery and an upper arm vein instead of the lower extremity approach using the femoral artery and femoral vein may reduce clinically relevant secondary access site-related bleeding complications, but robust evidence is lacking. TRIAL DESIGN: The TAVI XS trial is a multicentre, randomised, open-label clinical trial with blinded evaluation of endpoints. A total of 238 patients undergoing transfemoral TAVI will be included. The primary endpoint is the incidence of clinically relevant bleeding (i.e. Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding) of the randomised secondary access site (either diagnostic or pacemaker access, or both) within 30 days after TAVI. Secondary endpoints include time to mobilisation after TAVI, duration of hospitalisation, any BARC type 2, 3 or 5 bleeding, and early safety at 30 days according to Valve Academic Research Consortium­3 criteria. CONCLUSION: The TAVI XS trial is the first randomised trial comparing an upper extremity approach to a lower extremity approach with regard to clinically relevant secondary access site-related bleeding complications. The results of this trial will provide important insights into the safety and efficacy of an upper extremity approach in patients undergoing transfemoral TAVI.

Comparison of percutaneous closure systems for large bore vascular access sites in endovascular procedures.

Backgrounds: The vascular closure device (VCD) is a medical device used for achieving hemostasis of vascular access sites greater than 8 Fr. We compared complications after placement of Perclose ProGlide (Abbott Vascular, USA), a percutaneous suture-mediated closure system, with MANTA VCD (Teleflex Vascular, USA), a collagen-based closure device. Methods: This retrospective cohort study analyzed procedures performed between 2016 and 2021. We compared the incidence of bleeding complications according to the Bleeding Academic Research Consortium (BARC) and Valve Academic Research Consortium-3 (VARC-3) criteria. The comparison was made between two cohorts of patients: in the first, vascular access sites were closed with a double Perclose ProGlide system, and in the second with an 18 Fr MANTA VCD. Results: A total of 189 patients were included in the study, out of which 63% were male and 37% were female, with a median age of 79 (72-83) years. All devices were used for femoral arterial access closure. A double Perclose ProGlide was used in 91 (48%) patients, while MANTA VCD was used in 98 patients (52%). The distribution of patients by VARC-3 and BARC bleeding criteria differs between groups (p = 0.017). A significantly higher incidence of VARC 1 (14% vs. 4%; p = 0.020) and BARC 1-2 (14% vs. 4%; p = 0.020) complications in the Perclose ProGlide cohort was observed. VARC 3 (1% vs. 5%; p = 0.213) and BARC 3b (1% vs. 5%; p = 0.213) complications showed higher, but statistically non-significant rates of major bleeding complications in the MANTA VCD cohort. The need for subsequent surgical revision did not show a significant difference between the cohorts (2% vs. 6%; p = 0.281). Conclusion: The Perclose ProGlide cohort was associated with a significantly higher rate of milder complications. MANTA VCD cohort had a higher rate of major bleeding complications, requiring more complex treatment with a potentially larger impact on quality of life.

Transcatheter Aortic Valve Replacement With the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry.

BACKGROUND: The latest iterations of devices for transcatheter aortic valve replacement (TAVR) have brought refinements to further improve patient outcomes. OBJECTIVES: This study sought to compare early outcomes of patients undergoing TAVR with the self-expanding (SE) Evolut PRO/PRO+ (Medtronic, Inc) or balloon-expandable (BE) Sapien 3 ULTRA (Edwards Lifesciences) devices. METHODS: The OPERA-TAVI (Comparative Analysis of Evolut PRO vs Sapien 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry collected data from 14 high-volume centers worldwide on patients undergoing TAVR with SE or BE devices. After excluding patients who were not eligible for both devices, patients were compared using 1:1 propensity score matching. The primary efficacy and safety outcomes were Valve Academic Research Consortium-3 device success and early safety, respectively. RESULTS: Among 2,241 patients eligible for the present analysis, 683 pairs of patients were matched. The primary efficacy outcome did not differ between patients receiving SE or BE transcatheter aortic valves (SE: 87.4% vs BE: 85.9%; P = 0.47), but the BE device recipients showed a higher rate of the primary safety outcome (SE: 69.1% vs BE: 82.6%; P < 0.01). This finding was driven by the higher rates of permanent pacemaker implantation (SE: 17.9% vs BE: 10.1%; P < 0.01) and disabling stroke (SE: 2.3% vs BE: 0.7%; P = 0.03) in SE device recipients. On post-TAVR echocardiography, the rate of moderate to severe paravalvular regurgitation was similar between groups (SE: 3.2% vs BE: 2.3%; P = 0.41), whereas lower mean transvalvular gradients were observed in the SE cohort (median SE: 7.0 vs BE: 12.0 mm Hg; P < 0.01). CONCLUSIONS: The OPERA-TAVI registry showed that SE and BE devices had comparable Valve Academic Research Consortium-3 device success rates, but the BE device had a higher rate of early safety. The higher permanent pacemaker implantation and disabling stroke rates in SE device recipients drove this composite endpoint.

Durability of a bovine pericardial aortic bioprosthesis based on Valve Academic Research Consortium-3 echocardiographic criteria.

Objectives: The Carpentier-Edwards Perimount Magna Ease (Edwards Lifesciences) pericardial bioprosthesis has demonstrated satisfying hemodynamics at midterm follow-up, but its durability remains unclear. We report our 10-year experience with this third-generation valve implanted in the aortic position, with particular attention to structural valve deterioration. Methods: From 2007 to 2016 at our center, 338 patients underwent aortic valve replacement using the Perimount Magna Ease pericardial bioprosthesis. Patients were prospectively followed (mean 6.6 ± 2.6 years) with clinical evaluation and yearly echocardiography. Follow-up was 98% complete (7 patients lost) for a total of 2238 valve-years. Bioprosthesis structural valve deterioration was determined by strict echocardiographic assessment based on the Valve Academic Research Consortium 3 criteria. Results: Overall operative mortality was 1.2%. Actuarial survival including early deaths averaged 80.9% ± 2.2% and 66.7% ± 4.4% after 5 and 10 years of follow-up, respectively. Actuarial freedom from explantation due to structural valve deterioration at 5 and 10 years was 99.6% ± 0.4% and 88.8% ± 5.0%, respectively, and actuarial freedom of structural valve deterioration at 5 and 10 years was 98.5% ± 0.7% and 44.0% ± 6.4%, respectively. More precisely, actuarial freedom of structural valve deterioration stage 3 was 99.6% ± 0.4% at 5 years and 88.3% ± 5.0% at 10 years, whereas freedom of structural valve deterioration stage 2/3 was 98.5% ± 0.7% and 60.9% ± 7.0%, respectively. Conclusions: With a low rate of explantation due to structural valve deterioration events at 10 years, and particularly a low rate of moderate or severe structural valve deterioration based on echocardiographic Valve Academic Research Consortium 3 criteria, the Carpentier-Edwards Perimount Magna Ease pericardial bioprosthesis remains a reliable choice for a tissue valve in the aortic position.