Futuristic heart surgery with glowing aortic valve

Sutureless Aortic Valve Replacement: A Game Changer for Heart Patients?

Lena Voss in Health & Wellness July 2025 • 5 min read.

"One-Year Outcomes of the Perceval Bioprosthesis US Trial"

Aortic valve stenosis, a common heart condition, affects many individuals, particularly as they age. Traditional surgical aortic valve replacement (AVR) often involves a complex procedure with multiple sutures, which can be challenging for patients with age-related comorbidities. However, a groundbreaking innovation is changing the landscape of heart surgery: sutureless aortic valve replacement.

The Perceval sutureless aortic valve, representing a significant advancement in cardiac surgery, offers a streamlined approach to valve replacement. This device aims to reduce operative times and improve patient outcomes by eliminating the need for extensive suturing. The initial U.S. clinical trial has now provided us with one-year outcomes that confirm the device's safety and effectiveness.

This article delves into the outcomes of the prospective U.S. Investigational Device Exemption (IDE) trial of the Perceval sutureless aortic bioprosthesis, focusing on the one-year results. We will explore how this innovative approach compares to traditional methods, its benefits, and what it means for patients with aortic valve stenosis.

Key Findings from the Perceval US IDE Trial

Futuristic heart surgery with glowing aortic valve

The Perceval US IDE trial, conducted across 18 centers in the United States, involved 300 patients with a mean age of 76.7 years. The trial assessed the safety and efficacy of the Perceval sutureless aortic valve, with particular attention to operative mortality, stroke rates, and overall patient outcomes. Here’s a breakdown of the key findings:

Implantation Success: The Perceval valve was successfully implanted in 96.3% of patients. This high success rate underscores the reliability and ease of use of the device.

Low Operative Mortality: The operative mortality rate (within 30 days) was just 1.3%, significantly lower than expected based on risk prediction models.
Reduced Stroke Rate: The stroke rate at one year was remarkably low, at just 1%.
Improved Heart Function: A significant 98% of patients were in New York Heart Association (NYHA) class I/II at one-year follow-up, indicating improved heart function and reduced symptoms.
Quality of Life: Patients reported a significant improvement in their health-related quality of life (HR-QoL) scores, increasing from 62.7 before surgery to 85.5 at one year (P < .001).
Reduced Left Ventricular Mass: There was a notable decrease in left ventricular mass index, from 103.5 ± 30.1 g/m² at discharge to 95.8 ± 27.1 g/m² at one year (P = .001), suggesting improved cardiac remodeling.

These results highlight the potential of the Perceval sutureless valve to offer a safer, more effective alternative to traditional surgical aortic valve replacement.

The Future of Sutureless Aortic Valve Replacement

The findings from the Perceval US IDE trial are promising and suggest a bright future for sutureless aortic valve replacement. The reduced operative times, lower mortality rates, and improved patient outcomes make this approach an attractive option for individuals with aortic valve stenosis.

While these results are encouraging, it’s important to note some potential risks associated with the Perceval valve, including the need for new pacemaker implantation and aortic regurgitation. Ongoing randomized trials comparing the Perceval valve to standard sutured prostheses will provide further insights and help refine the optimal use of this technology.

Ultimately, the Perceval sutureless aortic valve represents a significant step forward in cardiac surgery, offering a less invasive and more efficient solution for aortic valve replacement. As more data becomes available and techniques continue to improve, sutureless AVR is poised to become an increasingly important tool in the fight against aortic valve disease.

About this Article -

This article was crafted using a human-AI hybrid and collaborative approach. AI assisted our team with initial drafting, research insights, identifying key questions, and image generation. Our human editors guided topic selection, defined the angle, structured the content, ensured factual accuracy and relevance, refined the tone, and conducted thorough editing to deliver helpful, high-quality information.See our About page for more information.

This article is based on research published under:

DOI-LINK: 10.1016/j.jtcvs.2018.08.121, Alternate LINK

Title: Prospective Us Investigational Device Exemption Trial Of A Sutureless Aortic Bioprosthesis: One-Year Outcomes

Subject: Cardiology and Cardiovascular Medicine

Journal: The Journal of Thoracic and Cardiovascular Surgery

Publisher: Elsevier BV

Authors: Rakesh M. Suri, Hoda Javadikasgari, David A. Heimansohn, Neil J. Weissman, Gorav Ailawadi, Niv Ad, Gabriel S. Aldea, Vinod H. Thourani, Wilson Y. Szeto, Robert E. Michler, Hector I. Michelena, Reza Dabir, Gregory P. Fontana, William F. Kessler, Michael G. Moront, Louis A. Brunsting, Bartley P. Griffith, Alvaro Montoya, Sreekumar Subramanian, Mark A. Mostovych, Eric E. Roselli

Published: 2019-05-01

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Everything You Need To Know

1

What advantages does the Perceval sutureless aortic valve offer over traditional aortic valve replacement?

The Perceval sutureless aortic valve offers a streamlined approach to aortic valve replacement by eliminating the need for extensive suturing. This can lead to reduced operative times, lower mortality rates, and improved patient outcomes compared to traditional surgical aortic valve replacement (AVR). The US IDE trial results showed high implantation success, low operative mortality (1.3%), reduced stroke rate (1%), and significant improvements in heart function and quality of life.

2

What was the design and purpose of the Perceval US IDE trial?

The Perceval US IDE trial was a prospective study conducted across 18 centers in the United States, involving 300 patients with a mean age of 76.7 years. Its purpose was to assess the safety and efficacy of the Perceval sutureless aortic valve. The trial focused on key outcomes such as operative mortality, stroke rates, improvement in New York Heart Association (NYHA) class, changes in quality of life (HR-QoL) scores, and reduction in left ventricular mass index.

3

How does the Perceval sutureless aortic valve impact heart function after the procedure?

The Perceval sutureless aortic valve resulted in a significant improvement in heart function. At one-year follow-up, 98% of patients were in New York Heart Association (NYHA) class I/II, indicating reduced symptoms and improved cardiac performance. Furthermore, the trial observed a notable decrease in left ventricular mass index, from 103.5 ± 30.1 g/m² at discharge to 95.8 ± 27.1 g/m² at one year, demonstrating improved cardiac remodeling. These factors contribute to better overall heart health and quality of life for patients.

4

What improvements in quality of life were observed in patients receiving the Perceval sutureless aortic valve?

The improvement in health-related quality of life (HR-QoL) scores after receiving the Perceval sutureless aortic valve was significant. Patients' HR-QoL scores increased from 62.7 before surgery to 85.5 at one year (P < .001). While the trial demonstrates significant improvements in the patient's quality of life, it does not account for specific instruments of HR-QoL used, such as the SF-36 or EQ-5D questionnaires. These scores would provide deeper insights into the nuanced aspects of HR-QoL improvements across various domains.

5

Does the Perceval US IDE trial provide information on the long-term durability of the Perceval valve?

While the Perceval US IDE trial focused on the one-year outcomes of the Perceval sutureless aortic valve, it primarily assessed safety and efficacy endpoints such as operative mortality, stroke rates, and improvements in heart function and quality of life. The trial did not specifically address the long-term durability of the Perceval valve. Further research and longer follow-up periods are needed to fully understand the valve's long-term performance and potential need for future re-interventions. This is a crucial consideration for patients and clinicians when evaluating the overall benefits of sutureless aortic valve replacement.