SAPIEN 3: Good Outcomes in Bicuspids

Courtesy of Dr. Carlos Fava.

Bicuspid aortic valves are found in approximately 2% of patients and represent the most frequent cause of aortic stenosis in young adults requiring valve replacement.

La SAPIEN 3 presenta buenos resultados en las bicúspides

Though TAVR has advanced significantly, this entity has not yet been included in the different randomized studies. At present, we have data from different reports, but no consolidation.

The study looked at the STS/ACC Registry, which included patients receiving the percutaneous valve SAPIEN 3 between June 2015 and November de 2018.

This analyzis included 81822 patients: 2726 presented bicuspid aortic valve (3.33%); the rest were tricuspid.

Bicuspid patients were more often men, younger, with fewer comorbidities and lower STS mortality score. After Propensity Score Matching, 2691 patients were left in each group, with mean age 74, 60% men and 4.9% STS.


Read also: AHA 2019 | Sapien vs Evolut: A Head-to-Head Study Seems Mandatory.


Bicuspid patients required a larger valve, regardless implantation or procedural success. At hospital level, there were no differences in mortality, but conversion to surgery, annulus rupture and stroke were more frequent in bicuspid patients.

At 30 days, there were no differences in mortality. In addition, there were elevated risks of stroke (2.5% vs 1.6%; absolute RD,0.89% [95% CI, 0.88% – 0.9%]; HR, 1.57 [95% CI, 1.06 – 2.33]) and definite pacemaker (9.1% vs 7.5%; absolute RD, 1.65% [95% CI, 1.63%-1.66%]; HR, 1.23 [95% CI, 1.02-1.49]) in bicuspid patients.

At one year, there were no differences in mortality or stroke in both groups.


Read also: TCT 2019 | Mitral Valve-in-Valve: 1-Year Results for Sapien 3 in Mitral Valve Replacement for Degenerated Bioprostheses.


There were no differences in valve hemodynamics profile at 30 days and one year in area, gradient or moderate to severe regurgitation.

Both groups improved functional class.

Conclusion

In this registry of propensity score matched patients, those receiving transcatheter aortic valve replacement for severe aortic stenosis in bicuspid or tricuspid valves showed no differences at 30 days and one year in mortality. However, there was increased stroke in bicuspid valve patients.

Given the potential bias in patient selection and the absence of a control group, these outcomes call for further study to better determine the safety and efficacy of transcatheter aortic valve replacement in bicuspid patients.

Courtesy of Dr. Carlos Fava.

Original Title: Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke.

Reference: Raj R. Makkar, et al. JAMA. 2019;321(22):2193-2202. doi:10.1001/jama.2019.7108.


Subscribe to our weekly newsletter

Get the latest scientific articles on interventional cardiology

We are interested in your opinion. Please, leave your comments, thoughts, questions, etc., below. They will be most welcome.

More articles by this author

Prospective Analysis of the Feasibility of the PASCAL System for Transcatheter Mitral Repair: OneForAll Registry

Courtesy of Dr. Juan Manuel Pérez. Mitral transcatheter edge-to-edge repair (M-TEER) is an effective option for patients with severe mitral regurgitation who are at high...

Left Bundle Branch Block after TAVR: What Is Its Impact?

Courtesy of Dr. Juan Manuel Pérez. Left bundle branch block (LBBB) is a common complication following transcatheter aortic valve replacement (TAVR), which can be either...

Multicenter Experience with 3D Intracardiac Echocardiography for Guiding Interventional Cardiac Procedures

Courtesy of Dr. Juan Manuel Pérez. Imaging techniques play a fundamental role in interventional cardiac procedures. Intracardiac echocardiography (ICE) appears as an alternative to transesophageal...

Pathology of Self-Expanding Transcatheter Aortic Bioprostheses and Hypoattenuated Leaflet Thickening

Courtesy of Dr. Juan Manuel Pérez. Despite the available long term followup data on of transcatheter aortic valve replacement (TAVR), bioprosthesis durability continues under debate....

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Related Articles

SOLACI Sessionsspot_img

Recent Articles

ACC 2025 | FAME 3: FFR Guided PCI vs CABG 5 Year Outcomes.

Earlier studies comparing percutaneous coronary intervention (PCI) vs coronary artery bypass graft (CABG) have shown fewer events at long term for the surgical strategy.  However,...

ACC 2025 | API-CAT: Reduced vs. Full Dose Extended Anticoagulation in Patients with Cancer Related VTE

The risk of cancer related recurrent venous thromboembolism (VTE) will drop over time, while bleeding risk will persist. At present, it is recommended we...

STRIDE: Semaglutide in Patients with Peripheral Arterial Disease and Type II Diabetes

Peripheral arterial disease (PAD) is a severe complication in patients with type II diabetes, primarily affecting peripheral vessels, especially below-the-knee (BTK) arteries. This condition...