The Edwards Evoque tricuspid valve replacement system is a minimally invasive solution designed to improve the health of patients suffering from severe tricuspid regurgitation. This article provides a comprehensive overview of the EVOQUE system, outlining its indications, contraindications, warnings, precautions, and potential adverse events. This information is crucial for healthcare professionals considering the EVOQUE valve for their patients.
Indications for EVOQUE Valve Implantation
The EVOQUE tricuspid valve replacement system is specifically indicated for patients experiencing symptomatic severe tricuspid regurgitation. These are individuals who, despite receiving optimal medical therapy, continue to suffer from the debilitating effects of this condition. The decision to proceed with EVOQUE valve replacement should be made by a Heart Team, ensuring a collaborative approach to patient care and the selection of the most appropriate treatment strategy. This multidisciplinary team will assess if tricuspid valve replacement with the EVOQUE system is the optimal pathway for improving the patient’s health status and quality of life.
Contraindications for EVOQUE Valve Use
While the EVOQUE valve offers a promising treatment option, certain contraindications must be carefully considered to ensure patient safety. The EVOQUE valve is contraindicated in patients with the following conditions:
- Intolerance to Anticoagulation/Antiplatelet Regimen: Patients unable to adhere to or tolerate the necessary post-implantation medication regimen are not suitable candidates.
- Active Bacterial Endocarditis or Other Active Infections: The presence of active infections poses a significant risk and must be resolved prior to considering valve implantation.
- Untreatable Hypersensitivity to Nitinol Alloys: Patients with known hypersensitivity to nickel and titanium, components of the nitinol alloys used in the EVOQUE valve, should not receive this device.
Critical Warnings Regarding the EVOQUE Valve
Several important warnings are associated with the EVOQUE valve and its delivery system that clinicians must be aware of:
- Single-Use and Sterility: The EVOQUE valve, delivery system, loading system, and dilator kit are provided sterile and are intended for single use only. Resterilization or reuse is strictly prohibited due to the risk of compromising sterility and device functionality.
- Valve Sizing is Paramount: Selecting the correct valve size is crucial for successful implantation. Improper sizing, whether undersizing or oversizing, can lead to serious complications such as paravalvular leak (PVL), valve migration, embolization, and annular damage. Careful pre-procedural planning and assessment are essential.
- Pre-existing Implanted Devices and Cardiac Leads: Patients with previously implanted devices like IVC filters or pre-existing cardiac leads require careful evaluation before EVOQUE valve implantation. Potential interactions and damage to vasculature or existing devices must be avoided. Similarly, caution is needed when implanting cardiac leads after EVOQUE valve placement to prevent adverse interactions.
- Anticoagulation/Antiplatelet Therapy Post-Implantation: Patients receiving the EVOQUE valve must be maintained on anticoagulant/antiplatelet therapy as determined by their physicians and current guidelines. This is essential to minimize the risk of valve thrombosis and thromboembolic events.
- Limited Data in Specific Patient Populations: Currently, there is insufficient data to support the safety and effectiveness of the EVOQUE valve in patients with:
- Echocardiographic evidence of severe right ventricular dysfunction.
- Pulmonary arterial systolic pressure (PASP) greater than 70 mmHg by echo Doppler.
- A trans-tricuspid pacemaker or defibrillator lead implanted in the RV within the last 3 months.
- Dependency on a trans-tricuspid pacemaker without alternative pacing options.
Important Precautions for EVOQUE Valve Procedures
In addition to warnings, several precautions should be observed during EVOQUE valve procedures:
- Anatomical Eligibility via CT Scan: Patient eligibility is dependent on specific anatomical conditions assessed through CT scans. Thorough pre-procedural imaging is mandatory.
- Heart Team Consensus: A multidisciplinary Heart Team should determine that EVOQUE valve implantation is the preferred approach compared to other percutaneous device solutions or minimally-invasive open-heart surgery.
- Hemodynamic Assessment: The Heart Team should consider disease severity and the potential reversibility of right heart failure based on a comprehensive hemodynamic assessment.
- Device Compatibility: The EVOQUE valve must only be used with the designated EVOQUE delivery system and EVOQUE loading system.
- Imaging Modalities: The procedure requires the use of appropriate imaging modalities, such as transesophageal echocardiography (TEE), fluoroscopy, and/or intracardiac echocardiography (ICE) to guide accurate valve placement.
- Glutaraldehyde Safety: Clinicians should be aware of the potential irritant nature of glutaraldehyde, used in the valve preparation. Proper ventilation and precautions to avoid skin and eye contact are necessary.
- Conduction Disturbances: Conduction disturbances are a potential risk before, during, or after EVOQUE valve implantation. Continuous ECG monitoring, especially post-procedure, is recommended. The risk may be elevated with the 56mm valve size.
- Antibiotic Prophylaxis: Appropriate antibiotic prophylaxis is recommended post-procedure, particularly for patients at risk of prosthetic valve infection and endocarditis.
- Long-Term Durability: The long-term durability of the EVOQUE valve is not yet established. Regular medical follow-up is crucial to monitor valve performance.
- Procedure Postponement: EVOQUE valve implantation should be postponed in patients with recent histories of:
- 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
As with any interventional procedure and implanted device, potential adverse events are associated with the EVOQUE valve and implantation process. These include, but are not limited to:
- Death
- Abnormal lab values
- Allergic reactions
- Anaphylactic shock
- Anemia
- Aneurysm or pseudoaneurysm
- Angina or chest pain
- Arrhythmias (atrial and ventricular)
- Arterio-venous fistula
- Bleeding
- Cardiac arrest
- Cardiac failure
- Cardiac injury, including perforation
- Cardiac tamponade / pericardial effusion
- Cardiogenic shock
- Chordal entanglement or rupture
- Coagulopathy
- Conduction system injury (requiring pacemaker)
- Conversion to open-heart surgery
- Coronary artery occlusion
- Pacemaker or ICD damage or interference
- Edema
- Electrolyte imbalance
- Embolization (air, particulate, thrombus)
- Emergent cardiac surgery
- Endocarditis
- Esophageal irritation or perforation
- EVOQUE system component embolization
- Failure to retrieve system components
- Fever
- Gastrointestinal bleeding
- Hematoma
- Hemodynamic compromise
- Hemolysis / hemolytic anemia
- Hemorrhage requiring transfusion/surgery
- Hypertension/Hypotension
- Inflammation
- Tricuspid apparatus injury
- Local and systemic infection
- Mesenteric ischemia or bowel infarction
- Multi-system organ failure
- Myocardial infarction
- Nausea and/or vomiting
- Nerve injury
- Neurological symptoms
- Non-emergent reoperation
- Pain
- Pannus formation
- Paralysis
- Percutaneous valve intervention
- Peripheral ischemia
- Permanent disability
- Pleural effusion
- Pneumonia
- Pulmonary edema
- Pulmonary embolism
- Reactions to anti-platelet or anticoagulation agents
- Rehospitalization
- Renal failure
- Respiratory failure
- Retroperitoneal bleed
- Right ventricular outflow tract (RVOT) obstruction
- Septicemia, sepsis
- Skin burn, injury from radiation
- Stroke
- Structural deterioration of the valve
- Thromboembolism
- Transient ischemic attack (TIA)
- Valve dislodgement/embolization
- Valve endocarditis
- Valve explant
- Valve leaflet entrapment
- Valve malposition/migration
- Valve paravalvular leak (PVL)
- Valve regurgitation (new or worsening)
- Valve thrombosis
- Vascular injury or trauma
- Vessel spasm
- Wound dehiscence, delayed healing
CAUTION: United States 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.
