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Five-Year Clinical Outcomes and Durability of a Self-Expanding Transcatheter Heart Valve With Intra-Annular Leaflets
Rishi Puri1, Holger Thiele2, Stephan Fichtlscherer3
1Cleveland Clinic, OH (R.P.).
Insights
The Portico transcatheter heart valve shows good 5-year durability and clinical outcomes in high-risk patients with severe aortic stenosis. This study confirms low failure rates and stable performance, offering a viable treatment option.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Limited data exists on the long-term durability of transcatheter heart valves.
- Assessing 5-year outcomes is crucial for understanding the longevity of these devices.
Purpose of the Study:
- To evaluate the 5-year clinical outcomes and valve durability of the Portico transcatheter heart valve system.
- To analyze pooled data from three harmonized studies for robust long-term assessment.
Main Methods:
- Patient-level data from three Portico studies were pooled using a random-effects meta-analysis.
- Follow-up data were collected annually through 5 years, with adverse events and echocardiographic data assessed per VARC-2 definitions.
Main Results:
- In 1464 high-risk patients, 5-year all-cause mortality was 49.4% and stroke rate was 12.3%.
- Bioprosthetic valve failure occurred in 2.7%, with no severe hemodynamic structural valve deterioration. Moderate deterioration was seen in 0.9%.
- Hemodynamic performance remained stable irrespective of annular size.
Conclusions:
- The Portico system demonstrated favorable 5-year clinical outcomes and hemodynamic performance in high-risk patients.
- Low rates of paravalvular leak and bioprosthetic valve failure, with no severe structural deterioration, support its use.
Background:
There is a paucity of data regarding the longer-term durability of transcatheter heart valves. This analysis aimed to describe the 5-year clinical outcomes and valve durability for patients treated with the Portico transcatheter heart valves across 3 studies harmonized in their prospective enrollment, inclusion/exclusion criteria, centralized independent core laboratory echocardiographic analysis, and independent clinical events committee adjudication.
Methods:
Patient-level data from the PORTICO IDE randomized controlled trial, the PORTICO I postmarket study, and the PORTICO continued access protocol were pooled using a random-effects meta-analysis model. All 3 studies collected follow-up data at discharge, 30 days, and annually through 5 years. Adverse events and pooled echocardiographic data were assessed using Valve Academic Research Consortium-2 definitions. Durability definitions were adapted from Valve Academic Research Consortium-3 and European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery consensus guidelines.
Results:
A total of 1464 patients with severe symptomatic aortic stenosis and high or extreme surgical risk were included. Median age was 83 years, 61.7% were women, and the median Society of Thoracic Surgeons score was 4.9%. At 5 years, all-cause mortality and stroke rates were 49.4% and 12.3%, respectively. Transvalvular gradient and effective orifice area at 5 years were 6.2 mm Hg and 1.83 cm2, respectively, with paravalvular leak ≥moderate severity occurring in 1.9%. The 5-year bioprosthetic valve failure rate was 2.7%, including a 0.7% valve-related death rate and a 2.0% valve reintervention rate, but no patients with severe hemodynamic structural valve deterioration. Moderate hemodynamic structural valve deterioration occurred in 0.9% of the patients at 5 years. Hemodynamic performance and transcatheter heart valve durability remained stable irrespective of annular size.
Conclusions:
The use of the Portico transcatheter heart valve system in patients at high or extreme surgical risk demonstrated favorable clinical outcomes and hemodynamic performance with low transvalvular gradients and greater than mild paravalvular leak. Furthermore, bioprosthetic valve failure rates were low with no incidence of severe hemodynamic structural valve deterioration at 5 years, irrespective of annular size.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT02000115 and NCT01802788.
