The Evoque Tricuspid Valve Replacement System by Edwards Lifesciences is a medical innovation specifically designed to improve the health status of patients grappling with symptomatic severe tricuspid regurgitation. This system is indicated for individuals who, despite receiving optimal medical therapy, continue to experience the debilitating effects of this condition and for whom a Heart Team has determined tricuspid valve replacement to be the most appropriate course of action. The EVOQUE system offers a less invasive alternative to traditional open-heart surgery, providing a potentially life-changing option for those in need.
Contraindications for EVOQUE Valve Implantation
While the EVOQUE valve offers significant benefits, it is not suitable for all patients. Contraindications for its use include:
- Intolerance to Anticoagulation/Antiplatelet Regimen: Patients who cannot tolerate the necessary medication regimen to prevent blood clots are not eligible for the EVOQUE valve.
- Active Bacterial Endocarditis or Other Active Infections: The presence of active infections, particularly bacterial endocarditis, is a contraindication due to the risk of infection spreading to the implanted valve.
- Untreatable Hypersensitivity to Nitinol Alloys: Patients with known and untreatable allergies to nitinol alloys, which include nickel and titanium, the materials composing the EVOQUE valve, should not receive this device.
Important Warnings Regarding the EVOQUE Valve
Several critical warnings must be considered before utilizing the EVOQUE valve system:
Single-Use and Sterility
The EVOQUE valve, its delivery system, loading system, and dilator kit are all provided sterile and are intended for single use only. Positioning accessories are available in both single-use, non-sterile disposable and reusable configurations. It is imperative to always refer to the device information to ensure intended use. Resterilization or reuse of any single-use components is strictly prohibited as the sterility, nonpyrogenicity, and functionality cannot be guaranteed after reprocessing.
Valve Sizing Considerations
Selecting the correct valve size is paramount for procedural success. Implantation of an improperly sized valve, whether undersized or oversized, can lead to serious complications such as paravalvular leak (PVL), valve migration, embolization, and/or damage to the annulus. Careful pre-procedural planning and sizing are crucial.
Considerations for Patients with Pre-existing Devices and Conditions
Patients with previously implanted devices, such as IVC filters, require careful assessment prior to delivery system insertion to avoid potential damage to vasculature or the existing device. Similarly, patients with pre-existing cardiac leads should be evaluated for potential adverse interactions with the EVOQUE valve. Caution is also advised when implanting cardiac leads after EVOQUE valve implantation to prevent adverse device interactions.
Anticoagulation/Antiplatelet Therapy
Post-implantation, patients with the EVOQUE valve must be maintained on anticoagulant or antiplatelet therapy, as determined by their physicians and in accordance with current medical guidelines. This regimen is crucial to minimize the risk of valve thrombosis and thromboembolic events.
Data Limitations for Specific Patient Populations
Currently, data supporting the safety and performance of the EVOQUE valve is limited for patients with certain pre-existing conditions. These include:
- Echocardiographic evidence of severe right ventricular dysfunction.
- Pulmonary arterial systolic pressure (PASP) exceeding 70 mmHg as measured by echo Doppler.
- Presence of a trans-tricuspid pacemaker or defibrillator lead implanted in the right ventricle within the last 3 months.
- Dependency on a trans-tricuspid pacemaker without viable alternative pacing options.
Precautions for EVOQUE Valve Use
Several precautions are necessary to ensure the safe and effective use of the EVOQUE valve:
Pre-procedural Assessment and Heart Team Evaluation
Prior to the procedure, a thorough assessment of the patient’s anatomic conditions based on CT scans is essential to determine eligibility. It is strongly recommended that a multidisciplinary Heart Team consensus be reached, confirming that EVOQUE valve implantation is the preferred approach compared to other percutaneous device solutions or minimally-invasive open-heart surgery. This team should also consider the severity of the patient’s condition and the potential for reversibility of right heart failure based on a comprehensive hemodynamic assessment.
Device Compatibility and Procedural Imaging
The EVOQUE valve is specifically designed for use only with the EVOQUE delivery system and EVOQUE loading system. The implantation procedure must be performed under appropriate imaging modalities, such as transesophageal echocardiography (TEE), fluoroscopy, and/or intracardiac echocardiography (ICE), to ensure accurate placement and procedural guidance.
Glutaraldehyde Exposure
The EVOQUE valve may contain glutaraldehyde, which can cause irritation to the skin, eyes, nose, and throat. Prolonged or repeated exposure or inhalation should be avoided. Procedures should be performed with adequate ventilation. In case of skin contact, immediately flush with water; for eye contact, seek immediate medical attention. Refer to the Safety Data Sheet from Edwards Lifesciences for detailed information on glutaraldehyde exposure.
Potential for Conduction Disturbances
Conduction disturbances may occur before, during, or after EVOQUE valve implantation and may necessitate continuous ECG monitoring post-procedure, especially before hospital discharge. The risk of conduction disturbances may be elevated with the 56mm valve size. Patients with confirmed or suspected conduction disturbances should be carefully monitored and may require electrophysiology evaluation.
Antibiotic Prophylaxis and Long-Term Durability
Appropriate antibiotic prophylaxis is recommended post-procedure for patients at risk of prosthetic valve infection and endocarditis. It is important to note that the long-term durability of the EVOQUE valve has not yet been fully established. Regular medical follow-up is crucial to evaluate the ongoing performance of the EVOQUE valve.
Procedure Postponement in Specific Clinical Scenarios
Implantation of the EVOQUE valve should be postponed in patients who have experienced any of the following within the specified timeframes prior to the planned intervention:
- Myocardial infarction within one month (30 days).
- Pulmonary emboli within 3 months (90 days).
- Cerebrovascular accident (stroke or TIA) within 3 months (90 days).
- Active upper GI bleeding within 3 months (90 days) requiring transfusion.
Potential Adverse Events Associated with EVOQUE Valve
Potential adverse events associated with cardiac catheterization, anesthesia use, the EVOQUE valve itself, and the implantation procedure are diverse and include, but are not limited to:
- Death
- Abnormal laboratory values
- Allergic reactions (anesthesia, contrast media, anticoagulation, device materials)
- Anaphylactic shock
- Anemia or decreased hemoglobin (potentially requiring transfusion)
- Aneurysm or pseudoaneurysm
- Angina or chest pain
- Arrhythmias (atrial and ventricular)
- Arterio-venous fistula
- Bleeding
- Cardiac arrest
- Cardiac failure
- Cardiac injury (perforation)
- Cardiac tamponade/pericardial effusion
- Cardiogenic shock
- Chordal entanglement or rupture (potentially requiring intervention)
- Coagulopathy/coagulation disorder/bleeding diathesis
- Conduction system injury (potentially requiring pacemaker implantation)
- Conversion to open-heart surgery
- Coronary artery occlusion
- Pacemaker or ICD damage or interference
- Edema
- Electrolyte imbalance
- Embolization (air, particulate, calcific material, thrombus, EVOQUE system components)
- Emergent cardiac surgery
- Endocarditis (valve endocarditis)
- Esophageal irritation/perforation/stricture
- Failure to retrieve EVOQUE system components
- Fever
- Gastrointestinal bleeding
- Hematoma
- Hemodynamic compromise
- Hemolysis/hemolytic anemia
- Hemorrhage (requiring transfusion/surgery)
- Hypertension/hypotension
- Inflammation
- Injury to the tricuspid apparatus (chordal damage, rupture, papillary muscle damage)
- Local and systemic infection
- Mesenteric ischemia or bowel infarction
- Multi-system organ failure
- Myocardial infarction
- Nausea and/or vomiting
- Nerve injury
- Neurological symptoms (dyskinesia without TIA/stroke diagnosis)
- Non-emergent reoperation
- Pain
- Pannus formation
- Paralysis
- Percutaneous valve intervention
- Peripheral ischemia
- Permanent disability
- Pleural effusion
- Pneumonia
- Pulmonary edema/embolism
- Reaction to anti-platelet or anticoagulation agents
- Rehospitalization
- Renal failure
- Respiratory failure/atelectasis (potentially requiring prolonged intubation)
- Retroperitoneal bleed
- Right ventricular outflow tract (RVOT) obstruction
- Septicemia/sepsis
- Skin burn/injury/tissue changes (radiation exposure)
- Stroke/Transient Ischemic Attack (TIA)
- Structural deterioration (wear, fracture, calcification, leaflet tear/thickening/motion disorder, stenosis)
- Thromboembolism
- Valve dislodgement/embolization/explant/malposition/migration/paravalvular leak (PVL)/regurgitation (new or worsening tricuspid, aortic, mitral, pulmonary)/thrombosis/leaflet entrapment
- Vascular injury/trauma (dissection or occlusion)/spasm
- Wound dehiscence, delayed or incomplete healing.
CAUTION: US Federal law restricts the sale of this device to or on the order of a physician. Refer to the instructions for use for complete prescribing information.
For further details, please visit Edwards.com/EVOQUE.
