This article is more than 5 years old. Information may no longer be current.
Societies publish recommendations for transcatheter mitral valve procedures
Click Here to Manage Email Alerts
Four societies have published a set of recommendations that outline criteria necessary for institutions in the implementation and maintenance of a transcatheter mitral valve program.
The writing committee for the consensus document — which was chaired by Carl L. Tommaso, MD, FACC, FSCAI, and included input from members of the Society for Cardiovascular Angiography and Interventions, American Association for Thoracic Surgery, American College of Cardiology and the Society of Thoracic Surgeons — suggested that transcatheter mitral valve repair and implantation requires a number of skills, special equipment, collaborative management techniques, surgical approaches and decision-making abilities, particularly in terms of patient selection.
Specifically, Tommaso and colleagues listed the following skills that they said are necessary in successfully implementing a mitral valve program:
- Coronary diagnostic procedures;
- Coronary interventions;
- Peripheral vascular diagnostic procedures;
- Peripheral vascular interventions;
- Balloon aortic, mitral and pulmonic dilatation;
- Stent implantation in right ventricle outflow tract and pulmonary arteries;
- Intra-aortic balloon pump and other cardiac support device placement, including initiation of percutaneous cardiopulmonary bypass;
- Placement of percutaneous ventricular assist device;
- Endovascular aneurysm repair or thoracic endovascular aneurysm repair;
- Transseptal techniques;
- Coronary sinus access;
- Large vessel access and closure.
“As [transcatheter mitral valve] techniques continue to increase in use, we must promote consistent, best practices and standards of care for providers and institutions so that patients get the best possible care,” Tommaso, who is the medical director of the cardiac catheterization lab, NorthShore University HealthSystem Skokie Hospital, Evanston, Ill., said in a press release. “These recommendations will help build and maintain programs centered on the best interests of patients.”
Necessary facilities
In the document, Tommaso and colleagues described some of the facilities institutions should possess for successful implementation of a transcatheter program. The first is a cardiac cath lab. They added that a hybrid operating room and cath lab equipped with a fixed radiographic imaging system also is acceptable. An echocardiographic laboratory, transthoracic and transesophageal echocardiographic capabilities, 3D echocardiography, a vascular laboratory and a CT laboratory are some of the non-invasive imaging techniques and facilities that should be made available. Additional features that should be present include circulating HVAC laminar flow diffusers, asymmetrical or symmetrical 6-lamp 2X4 troffers and an adequate power supply. The authors recommend a room size of a minimum of 800 square feet for the interventional suite.
Carl L. Tommaso
Cardiopulmonary bypass equipment and staff may be made available but are not strictly necessary, the authors wrote. However, the interventional suite should carry access kits for various procedures and a range of endovascular sheaths and introducers, guidewires, cardiac diagnostic and interventional catheters, vascular closure devices, balloon dilatation catheters, bare-metal and covered stents, occlusive vascular devices, snares and other retrieval devices, drainage catheters and various implantable device sizes, according to the authors. Delivery systems for these devices also should be available. A mobile C-arm imaging system is contraindicated. The authors suggested that an intensive care facility should be made available for post-procedure recovery and complications.
Multidisciplinary team
Although a cardiac surgeon and an interventional cardiologist should evaluate each case, a multidisciplinary approach is recommended. Additional specialists in cardiac anesthesiology, intensive care, cardiac imaging, congenital heart disease surgery, vascular surgery and interventional radiology also should be involved in case management. Nurse practitioners in these fields should work with research coordinators and a dedicated administrator to ensure optimal performance.
The consensus document stipulates that facilities should perform a certain number of procedures each year. At the institutional level, 1,000 catheterizations and 400 PCI should be conducted per year. Interventionalists should perform 50 structural procedures, while 25 mitral valve procedures should be conducted each year by the surgical program. Fifteen mitral procedures should be performed in existing programs. For new programs, Tommaso and colleagues wrote that because the indications are not defined, no volume criteria can be proposed yet.
They added that a number of training programs should be implemented, and that operators must meet all board certifications.
The document also contains specific recommendations for mitral valve repair, which the authors said is a particularly difficult procedure. They added that the MitraClip (Abbott Vascular) is the only FDA-approved device for this procedure.
All participating facilities that conduct catheter-based procedures should participate in the national registry by registering cases in the TVT-NCDR database.
Disclosure: The authors report financial disclosures with Abbott, Boston Scientific, Carbomedics, Colibri Heart Valve, Edwards Lifesciences, Numed Inc., Occlutech, Phillips Medical, Sorin, St. Jude Medical, Venus Medtech and W.L. Gore.
Collapse
Click Here to Manage Email Alerts