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Self-Expanding Intra-Annular Transcatheter Aortic Valve Replacement System in Patients With Severely Calcified Aortic
Andrea Ruberti1, Giovanni Occhipinti2, Matias Mon3
1Hospital Clínic, Cardiovascular Clinic Institute, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Catalunya, Spain; Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Catalunya, Spain; Facultat de Medicina i Ciencies de la Salut, Universitat de Barcelona (UB), Barcelona, Spain. Electronic address: https://x.com/a_rubi_5.
Insights
Severe aortic valve calcification (AVC) does not compromise transcatheter aortic valve replacement (TAVR) outcomes with self-expanding intra-annular valves. Patients with severe AVC had similar 30-day device success but higher 12-month heart failure hospitalizations.
Area of Science:
- Cardiology
- Interventional Cardiology
- Biomaterials Science
Background:
- Severe aortic valve calcification (AVC) poses challenges for transcatheter aortic valve replacement (TAVR).
- Outcomes of TAVR using self-expanding intra-annular transcatheter heart valves (THVs) in patients with severe AVC are not well-established.
- Assessing the impact of AVC severity on TAVR outcomes is crucial for patient selection and procedural planning.
Purpose of the Study:
- To evaluate the effect of severe AVC on procedural and clinical outcomes in patients undergoing TAVR.
- To compare outcomes between patients with severe AVC (≥ 3000 Agatston units) and those with non-severe AVC (< 3000 Agatston units).
- To assess the performance of self-expanding intra-annular THVs in a high-risk population.
Main Methods:
- Retrospective, multicenter study involving patients treated with Portico or Navitor THVs.
- Patients were stratified into severe AVC (≥ 3000 AU) and non-severe AVC (< 3000 AU) groups.
- Primary endpoint was 30-day device success; secondary endpoints included procedural success, pacemaker implantation, and 12-month clinical outcomes.
Main Results:
- Severe AVC was associated with higher AVC density and mean transvalvular gradient.
- Thirty-day device success rates were similar between severe and non-severe AVC groups (89.7% vs 89.6%).
- Severe AVC patients had higher rates of procedural predilation and a trend towards increased permanent pacemaker implantation. Despite comparable valve performance, 12-month heart failure hospitalizations were significantly higher in the severe AVC group (13.8% vs 3.8%). Portico THV showed a higher risk of device failure compared to Navitor THV.
Conclusions:
- Self-expanding intra-annular THVs are effective and safe for patients with severe AVC.
- Achieving comparable procedural success and 30-day device success is possible even with severe calcification.
- While valve performance is similar, increased 12-month heart failure hospitalizations in severe AVC patients warrant further investigation and monitoring.
Background:
Outcomes of patients with severe aortic valve calcification (AVC) undergoing transcatheter aortic valve replacement (TAVR) with self-expanding intra-annular transcatheter heart valves (THVs) remain uncertain. The aim of this study is to assess the impact of AVC severity on procedural and clinical outcomes following TAVR with self-expanding intra-annular THVs.
Methods:
This retrospective, multicentre study included patients treated with Portico or Navitor THVs (Abbott Cardiovascular, Santa Clara, CA). Patients were stratified by AVC burden (severe ≥ 3000 Agatston unit (AU) vs nonsevere < 3000 AU). The primary endpoint was 30-day device success.
Results:
Among the 371 patients included (64% female; median Society of Thoracic Surgeons [STS] 3.7%), 86 (23.1%) had AVC ≥ 3000 AU. This group presented higher AVC density (9.0 AU/mm2 [0.8-25.3] vs 4.2 AU/mm2 [0.8-8.8]; P < 0.001) and echocardiographic mean transvalvular gradient (47 mm Hg [13-103] vs 44 mm Hg [15-95]; P < 0.001) compared with the nonsevere AVC group. Thirty-day device success was similar between groups (89.7% vs 89.6%; P = 0.988). Technical success occurred in 93.8% of patients. Severe AVC was associated with higher rates of procedural predilation (98.8% vs 93.3%; P = 0.048). A higher permanent pacemaker implantation rate was observed in the severe AVC group (30.2% vs 20.3%; P = 0.055). Despite comparable valve performance, 12-month heart failure-related hospitalizations were higher in the severe AVC group (13.8% vs 3.8%; P = 0.001). Finally, Portico THV was associated with a 3-fold increase risk of device failure (odds ratio [OR], 2.96; P = 0.011) compared with Navitor THV.
Conclusions:
The use of self-expanding intra-annular THVs seems to be an effective and safe strategy also for patients with severe AVC, achieving comparable outcomes with those with lower calcification burden.
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