Transcatheter Aortic Valve Replacement With the Latest-Iteration Self-Expanding or Balloon-Expandable Valves

Costa, Giuliano; Saia, Francesco; Pilgrim, Thomas; Abdel‐Wahab, Mohamed; Garot, Philippe; Valvo, Roberto; Gandolfo, Caterina; Branca, Luca; Latib, Azeem; Santos, Ignacio Amat; Mylotte, Darren; Marco, Federico De; Franco, Luis Nombela; Akodad, Mariama; Mazzapicchi, Alessandro; Tomii, Daijiro; Laforgia, Pietro L; Cannata, Stefano; Fiorina, Claudia; Scotti, Andrea; Lunardi, Mattia; Poletti, Enrico; Mazzucca, Mattia; Quagliana, Angelo; Hennessey, Breda; Meier, David; Adamo, Marianna; Sgroi, Carmelo; Reddavid, Claudia; Strazzieri, Orazio; Motta, S.; Frittitta, Valentina; Dipietro, Elena; Comis, Alessandro; Melfa, Chiara; Thiele, Holger; Webb, John G.; Søndergaard, Lars; Tamburino, Corrado; Barbanti, Marco

doi:10.1016/j.jcin.2022.08.057

Cited by 40 publications

(21 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Approximately one-fifth of the study 26 Despite the treatment of more complex anatomies, from 2017 through 2021, VARC-3 defined technical success and intended performance of the valve remained high and stable (Q4, 94% and 95%, respectively), with VARC-3 device success and early safety that even improved to 88% and 78%, respectively. These findings compare favorably with contemporary registries on TAVR 27 and will represent an important reference for future experiences in TAVR using SEV.…”

Section: Discussionsupporting

confidence: 57%

Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries

Scotti

Baggio

Pagnesi

et al. 2023

Circ: Cardiovascular Interventions

Self Cite

View full text Add to dashboard Cite

Background: In recent years, transcatheter aortic valve replacement (TAVR) techniques and technology have continuously improved. Data regarding the impact of these advancements on outcomes in large real-world settings are still limited. The aim of this study was to investigate temporal trends and assess contemporary outcomes after TAVR with Evolut PRO/PRO+ supra-annular self-expanding valves. Methods: This study included patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries who underwent transfemoral TAVR with Evolut PRO/PRO+. Procedural dates (August 2017 through November 2021) were stratified in quartiles (Q) and used to investigate temporal trends in TAVR outcomes. Predischarge, 30-day Valve Academic Research Consortium-3 defined, and 1-year outcomes were evaluated. Results: In total, 1616 patients from 28 centers were included. Over time, patients had lower Society of Thoracic Surgeon-Predicted Risk of Mortality score (Q1–4, 4.1% [2.8–6.3%], 3.7% [2.6–5.3%], 3.3% [2.4–4.9%], 2.9% [2.2–4.3%]; P <0.001) and more moderate or heavy valve calcification (Q1–4, 80%, 80%, 82%, 88%; P =0.038). Overall Valve Academic Research Consortium-3 technical success was 94.1%, with 30-day and 1-year all-cause mortality of 2.4% and 10%, respectively. Throughout the study period, procedures were associated with higher rates of 30-day device success (Q1–4, 81.2%, 82.2%, 82.0%, 88.0%; Cochran-Armitage P =0.023) and early safety (Q1–4, 66.8%, 67.5%, 74.0%, 77.6%; Cochran-Armitage P <0.001), with fewer permanent pacemaker implantations (Q1–4: 15.3%, 20.0%, 12.1%, 11.6%; Cochran-Armitage P =0.023) and residual mild or greater paravalvular leaks (Q1–4, 50.4%, 42.1%, 36.5%, 35.8%; Cochran-Armitage P <0.001). Conclusions: TAVR with Evolut PRO/PRO+ self-expanding valve is safe and effective. Despite the treatment of heavier calcified anatomies, procedural outcomes are improving over time with less need for pacemaker implantation and less significant paravalvular leaks.

show abstract

Section: Discussionsupporting

confidence: 57%

Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries

Scotti

Baggio

Pagnesi

et al. 2023

Circ: Cardiovascular Interventions

Self Cite

View full text Add to dashboard Cite

show abstract

“…Last but not least, the need for new permanent pacemaker implantation following TAVR procedures complicated by high-degree conduction abnormalities was similar in both our groups (8.6% for TA and 9.8% for TAO; p = 1.000) despite self-expanding valves (known for causing a higher incidence of conduction disturbances) were more often used in the TAO group (24% vs. 47.6%, respectively). These results are interestingly better than data recently reported from the multicentre OPERA-TAVI registry comparing very last-generation, self-expanding and balloon-expandable transcatheter devices [15]. The permanent pacemaker implantation rate was reported as 17.9% for the self-expanding cohort and 10.1% for the balloon-expandable cohort.…”

Section: Discussioncontrasting

confidence: 49%

Ten-Year Experience with Transapical and Direct Transaortic Transcatheter Aortic Valve Replacement to Address Patients with Aortic Stenosis and Peripheral Vascular Disease

Ferrari

Pozzoli

Klersy

et al. 2022

JCDD

View full text Add to dashboard Cite

Objective: Transcatheter aortic valve replacement (TAVR) through alternative access routes is indicated in patients with severe aortic valve stenosis and diseased peripheral arteries. We analysed and compared the outcome of patients undergoing transapical (TA) and direct transaortic (TAO) TAVR procedures. Methods: Preoperative characteristics, procedural details, and thirty-day outcome of patients undergoing transapical (TA-TAVR group) and direct transaortic (TAO-TAVR group) TAVR procedures were prospectively collected and retrospectively analysed. Results: From March 2012 to March 2022, 81 TA and 82 TAO-TAVR (total: 163 cases) were performed with balloon-expanding (n = 120; 73.6%) and self-expandable (n = 43; 26.4%) valves. The mean age was 79.7 ± 6.2 and 81.9 ± 6.7 years for the TA- and TAO-TAVR groups, respectively (p = 0.032). Females were more represented in the TAO-TAVR group (56% vs. 32%; p = 0.003) while TA-TAVR patients showed a higher prevalence of previous vascular surgery (20% vs. 6%; p = 0.01), previous cardiac surgery (51% vs. 3.6%; p < 0.001), and porcelain aorta (22% vs. 5%; p = 0.001). The mean ejection fraction was 49.0 ± 14.6% (TA) and 53.5 ± 12.2% (TAO) (p = 0.035) while mean gradients were 35.6 ± 13.2 mmHg (TA) and 40.4 ± 16.1 mmHg (TAO) (p = 0.045). The median EuroSCORE-II was 5.0% (IQR: 3.0–11.0) and 3.9% (IQR: 2.5–5.4) for the TA- and TAO-TAVR groups, respectively (p = 0.005). The procedural time was shorter for TA procedures (97 min (IQR: 882–118) vs. 102 min (IQR: 88–129); p = 0.133). Mortality at day 30 was 6% in both groups (p = 1.000); the permanent pacemaker implantation rate was similar (8.6% vs. 9.7%; p = 1.000), and hospital stay was shorter for the TAO group (8 days (IQR: 6–11) vs. 10 days (IQR: 7–13); p = 0.025). Conclusions: Our results show that transapical and direct transaortic TAVR in high-risk patients with diseased peripheral arteries provide satisfactory clinical results with similar thirty-day outcomes.

show abstract

“…self-expanding (SE) versus balloon expandable (BE), with SE leading to higher rates of PPI and lower rates of PPM, as compared to BE. (10-12)…”

Section: Introductionmentioning

confidence: 99%

Sex-Related Outcomes of Transcatheter Aortic Valve Implantation with Self-Expanding or Balloon-Expandable Valves: Insights from the OPERA-TAVI Registry

Adamo,

Branca,

Pezzola

et al. 2023

Preprint

Self Cite

View full text Add to dashboard Cite

Background: Evidence regarding sex-related differences in response to transcatheter aortic valve implantation according to the valve type is lacking. This study sought to evaluate the impact of sex on the treatment effect of Evolut-PRO/PRO+ (PRO) or Sapien 3 Ultra (ULTRA) devices on clinical outcomes. Methods: Comparative Analysis of Evolut PRO vs Sapien 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation (OPERA-TAVI) is a multicenter multinational registry including patients undergoing latest-iteration PRO or ULTRA implantation. Overall, 1174 out of 1897 patients were matched based on valve type and compared according to sex, while 470 males and 630 females were matched and compared according to valve type. Thirty-day and 1-year outcomes were evaluated. Results: In both PRO and ULTRA group, males had a higher comorbidity burden, while females had smaller aortic root. Both 30-day (device success [DS], early safety outcome, permanent pacemaker implantation [PPI], patient-prosthesis mismatch [PPM], paravalvular regurgitation [PVR], bleedings, vascular complications, and all-cause death) and 1-year outcomes (all-cause death, stroke and heart failure hospitalization) did not differ according to sex in both valve groups. However, male sex decreased the likelihood of 30-day DS with ULTRA versus PRO (p for interaction 0.047). A higher risk of 30-day PPI and 1-year stroke, and a lower risk of PPM was observed in PRO versus ULTRA, regardless of sex. No other differences were noted. Conclusions: Sex did not modify the treatment effect of PRO versus ULTRA on clinical outcomes, with the exception of 30-day DS that was decreased in males (versus females) receiving ULTRA (versus PRO).

show abstract

Transcatheter Aortic Valve Replacement With the Latest-Iteration Self-Expanding or Balloon-Expandable Valves

Cited by 40 publications

References 23 publications

Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries

Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries

Ten-Year Experience with Transapical and Direct Transaortic Transcatheter Aortic Valve Replacement to Address Patients with Aortic Stenosis and Peripheral Vascular Disease

Sex-Related Outcomes of Transcatheter Aortic Valve Implantation with Self-Expanding or Balloon-Expandable Valves: Insights from the OPERA-TAVI Registry

Contact Info

Product

Resources

About