Medtronic, Abbott, and Edwards Lifesciences Unveil Latest TAVR Clinical Data at CRT 2024

Mar 14, 2024 16:56 CST Updated 16:56

Abbott

Diagnostic and pharmaceutical product manufacturers

Medtronic

Chronic Disease Medical Device and Therapy Developer

Source of the article:Heart NotCome;Editor: Sophia

Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.

Heart Future

Recently, Cardiovascular Research Technologies(CRT) ConferenceConvened in Washington, D.C., USA,Major Companies Release Latest Clinical Data for Cardiovascular Treatment Devices。Data show thatTranscatheter Aortic Valve Replacement (TAVR)Treating Low-Risk PatientsCostMay be more than surgeryLower.

Among them,Medtronic, Abbott, EdwardsWorkForLeader in Structural Heart Disease，Bring respectivelyEvolut、Portico TAVR、Amplatzer Amulet、SAPIENLatest research data on products such as...To confirm the clinical value of their respective products.

Generally speaking, aortic valve diseases mainly include:

Aortic Stenosis

Treatment Method:The specific choice of surgical plan needs to be evaluated and determined by a professional doctor.

1）Surgical Aortic Valve Replacement (SAVR)

2）Transcatheter Aortic Valve Replacement (TAVR/TAVI)

Aortic Valve Regurgitation

Treatment Method:

1) Currently, the majorityPatientSelectionSurgical Aortic Valve Replacement (SAVR) for treatment,Because SAVR has been performed for more than 50 years, the concept and technology are very mature.

For a long time before,Clinical data from various companies have confirmedThe all-cause mortality rate of TAVR is much higher than that of SAVR.But the data published by Edwards and Medtronic at the 2023 TCT conference rekindled hope.Especially as announced by MedtronicEvolut Low Risk TrialResearch,All-cause mortality of TAVR has alreadyApproaching or even lower than SAVR。

The announcement of Medtronic's results alsoCaused a StirAmerican cardiac surgeons criticized Medtronic for publishing SAVR data in a study that was significantly lower than the industry average. In response, at this conference, Medtronic excluded Abbott's Trifecta surgical valve (which had been withdrawn from the market due to quality issues) from the study. After exclusion, it was found that the four-year all-cause mortality or disabling stroke rate for SAVR was 10.2% (0.1% lower than when Trifecta was included).

So, what data have the major companies released this year? How is the data performance?

# Medtronic: Cost-effectiveness, Clinical Data

Research Purpose:Evolut Low Risk Trial aims to evaluate Evolut TAVR compared with SAVR.Safety and Effectiveness in Low-Risk Patients.

Research Subject:Low-risk patients, defined as having a lower predicted risk of 30-day surgical mortality

Number of Objects:Total1,414 patientsAttempted Implantation(730 TAVR, 684Name SAVR)

Distribution Method：Random Allocation

Treatment Method:Self-expanding Supra-annular Evolut R, PRO or CoreValvePerform TAVR treatment; andSAVR Therapy

Experiment Duration:4 Years

Data Analysis:

From the perspective of the U.S. healthcare system,Evolut TAVR Offers Strong Economic Benefits for Low-Risk Patients。

1) Evolut TAVR per Quality-Adjusted Life Year (QALY) gainedLifetime Incremental Cost-Effectiveness Ratio (ICER) is$2119`, which is consistent with high economic value.`。

QALY Definition:Converting the number of survival years with different quality of life intoQuality of life equivalent to that of a completely healthy personNumber of years stored.Calculation method: QALY = (Life years × Quality of life weight)
If 1 represents completionChinaHealth, 0 TableIndicationDeath, so 4 years in moderate health is equivalent to 2.Quality-Adjusted Life Year.
Definition of ICER:Indicates the incremental cost required to gain one additional QALY with the intervention compared to the control, i.e., a comparison.Is the cost-effectiveness of the experimental group high or not?。
Calculation Method:ICER = (Cost1 - Cost0) / (QALY1 - QALY0)

Currently,American College of CardiologyACC、American Heart AssociationAHA Definition of the published guidelines:

ICER per QALY gained<50,000 USD indicates "high value", ranging from 50,000 to 150,000 U.S. dollars is considered "intermediate value." Therefore,Evolut TAVR falls within the high-value category.。

2) At 30 days, the estimated cost of TAVR was lower than that of SAVR.

Estimated Cost of TAVRIncluding index surgery, hospitalization, and rehabilitation,$45,887，The cost of SAVR is $51,075.The difference between the two is $5,189.。

Evolut TAVThe 4-year experimental data analysis results of R are very positive.

MedtronicTAVR and SAVR in Patients with Severe Aortic StenosisResults Re-evaluation,Excluding the previously discontinued Trifecta surgical valve due to durability issues.The analysis includes1292ExampleEvaluation of Patients Attempting Implantation. Analysis Found:

1) SAVRCohortFour-Year All-Cause Mortality or Incidence of Disabling StrokeFor14.2%(p=0.06), andThe rate in the Evolut TAVR group was 10.7%.，Performing well。

This shows that,Evolut TAVR is betterValve Durability Index(Mean gradient 9.8 mmHg TAVR; 11.8 mmHg SAVR; p<0.001).

Expert Evaluation:

Regarding the clinical data released by Medtronic, Professor Basel Ramlawi from the Lankenau Medical Center commented as follows:

“"These new data support the promotion and use of TAVR in the future, perhaps allowing TAVR to reach more patients with heart valve disease. I am greatly encouraged because this indicates that we have an additional option compared to surgery."

# Abbott: Products Are Safe and Effective, Let the Data Speak

Abbott announced at CRT 2024Portico, Navitor, and Amplatzer AmuletClinical research data for three products.

Portico：Abbott's First-Generation TAVR Product, Abbott's Presentation This TimePorticoThree Clinical StudiesSummary Analysis. ResearchDisplay,Portico hasThe Role of Good Continuous Blood Flow and Prevention of Paravalvular Leakage (PVL)。

Due to the wide range of annulus sizes, under high-accuracy valve matching,The incidence of clinical events is low.。Treating severe symptomatic aortic stenosis in high-risk and extreme surgical risk patients within five years,Portico is relatively safe and effective.。

Navitor：Abbott's Latest Generation TAVR Product, AbbottNavitor IDE The study collected data from patients inSurgery, Discharge, 30-day Follow-up, 12-month Follow-up, and Subsequent Annual Follow-ups5Year CountAccording to。

The one-year data of the study showed:

1) Navitor Can Prevent99.5%Mild PVL；

2) Accepting the Navitor system1 YearLower mortality rate;

3) Treated with NavitorThe incidence of paravalvular leak (PVL) in patients was also lower., with good valve hemodynamics and reduced clinical events within one year.

Amplatzer Amulet：Amplatzer™ Amulet™ Left Atrial Appendage Occluder by AbbottNew Generation Closure Device, which obtained the EU CE certification in 2013, has been approved in more than 80 countries, including Europe, Canada, and Australia.

The U.S. FDA approved Abbott's Amplatzer™ Amulet™ Left Atrial Appendage Occluder in August 2021 for the treatment of atrial fibrillation patients at risk of ischemic stroke.This is also the second transcatheter left atrial appendage closure device in the U.S. market.。

This left atrial appendage occluder adoptsDouble Seal Technology，Fill the main body of the left atrial appendage with lobes or paddles, and seal it with a disk.The device can immediately close the left atrial appendage,Severe peripheral leakage (PDL) is less, reducing the risk of stroke.

Abbott Summary AnalysisClinical data of patients who underwent left atrial appendage closure device implantation from August 2021 to June 2023.

Results IncludeA success rate of over 97% and high closure(More than 96.5%,Regardless of the doctor's experience）。

# Edward:Two Real-World Data Analyses

Edward announced2ItemResults from large real-world studies that evaluatedResults of the latest generation Sapien 3 Ultra Resilia valve.

1) Edward collected the United StatesMore than 10,000Clinical data of patients implanted with the Sapien series,WillSapien 3 Ultra ResiliaComparison with Sapien 3 and Sapien 3 Ultra, and the results showed that:

All valve sizes have a lower rate of paravalvular leakage (PVL), lower echo-derived gradients, and larger effective orifice areas.。
The Sapien 3 Ultra Resilia valve has lower rates of all-cause mortality, cardiovascular mortality, all strokes, life-threatening bleeding, major vascular complications, and permanent pacemaker implantation at discharge or 30 days.

2) Collect data from more than 800 centers in the United States8,100Implant Sapien series clinical data and conduct analysis. The analysis found:Patients Treated with 20 mm Sapien ValveWithin three yearsAll-cause mortality and stroke rateNeither is high.

ResiliaTissue processing technology is aTechnology for Advanced Anti-Calcification Treatment of Bovine Pericardial Tissue, is a new generation valve technology platform developed by Edwards.ResiliaThe organization has provenNo structural valve deterioration will occur within 5 years.，And may extendSapien 3 Ultra ResiliaDurability of the Valve。

EdwardAndMedtronicIt can be said that the TAVR track is"Double C"，Currently, it has accumulated a significant number of clinical advantages.Edward Life Sciences, as the absolute leader, accounts for up to 60%;Medtronic follows with a share of approximately 30%.Due to the current increase in the number of patients with heart valve disease,TThe coverage rate of AVR is still relatively low, attracting numerous companies to enter this field.

However, to challenge the TAVR duo, more is needed.Further technological innovation and more clinical data to confirm its TAVR clinical value, earning the trust of the industry。

# Global Leading Cardiovascular Device Company

Medtronic｜Johnson & Johnson MedTech|Boston ScientificBoston Scientific|

Edwards Lifesciences | Abbott Abbott｜

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China Cardiovascular Innovation Device List [2023 Review]

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XinQing Medical (Interventional Ventricular Assist System NyokAssist)

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