Position Statement for the Operator and Institutional Requirements for a Transcatheter Aortic Valve Implantation (TAVI) Program

Transcatheter aortic valve implantation. Expert Consensus of the Association of Cardiovascular Interventions of the Polish Cardiac Society and the Polish Society of Cardio-Thoracic Surgeons, approved by the Board of the Polish Cardiac Society…

“…Therefore, interventional cardiologists should take part in courses and practical training in: -interventional treatment of structural heart diseases; -interventional diagnosis and treatment of peripheral artery diseases; -peripheral artery access site management and closure; -extracorporeal membrane oxygenation (ECMO) placement and patient management [13,15,17,18,21,83,90,95,[127][128][129].…”

“…Cardiac surgeon A cardiac surgeon -an Independent TAVI Operator -should fulfil the criteria defined by the Skill Certificate, issued specifically by the Polish Society of Cardio-Thoracic Surgeons, after the following experience and skills in TAVI have been documented: -a board-certified specialisation in cardiac surgery; -operator experience in surgical valve replacement, with the minimum of 300 structural heart operations; -operator experience in surgical valve reoperations, with the minimum of 25 reoperations; -ECMO placement and patient management; -participation in TAVI training, as recommended by the Polish Society of Cardio-Thoracic Surgeons or European societies: EACTS/ESC/ESCVS, or other specialisation courses; -operator experience in at least 20 TAVI procedures [13,15,17,18,21,83,[129][130][131]; -at least 10 TAVI procedures performed yearly afterwards; -formal training on the use of available TAVI systems, including a practice in an experienced TAVI centre. At a minimum, the training should include educational presentations and participation in at least two TAVI procedures performed in a reference TAVI centre [90,95,127,128].…”

“…Moreover, the TAVI centre should fulfil the following criteria [13,15,17,18,21,83,90,95,132]: -perform no less than 1000 coronary angiography and no less than 700 coronary angioplasty procedures in a calendar year; -perform at least 150 SAVR in a calendar year, including at least 15 SAVR in high-risk patients (STS ≥ 8%, Euro-SCORE II ≥ 8%); • echocardiography lab, performing transthoracic and transoesophageal examinations. Its staff must be trained in imaging of structural heart diseases and their interpretation, • access to a vascular laboratory capable of performing vascular imaging examinations and their interpretation, • access to a computed tomography laboratory, capable of performing heart and vessel computed tomography imaging and its interpretation; -catheterisation lab/operating room certified for pacemaker and implantable cardiac defibrillator implantations; -essential equipment to treat various TAVI complications, such as heart conduction abnormalities, aortic and peripheral artery perforation, cardiac tamponade, and cardiogenic or hypovolaemic shock; -ECMO availability and TAVI team experience in its implantation and management in life-threatening conditions; -(Cardiology) Intensive Care Unit or Postoperative Intensive Care Unit present on-site; -renal replacement therapy available on-site.…”

“…Encouraging results of this novel therapy in prohibitive-, high-, and moderate-risk patients in Poland were possible thanks to the combination of several factors: full support and growing experience of national scientific societies, the introduction of dedicated TAVI programmes in centres with established invasive cardiology and cardiac surgery departments, as well as the organisation of integrated TAVI teams in each of them [13][14][15][16][17][18][19][20][21][22]. The role and indications to SAVR in the future will most probably reflect growing TAVI demand.…”

Transcatheter aortic valve implantation

“…In patients without indications for chronic anticoagula tion, dual antiplatelet therapy is used to prevent thrombosis of the aortic valve prosthesis for 1-6 months after TAVI, using daily maintenance doses of 75-100 mg of ASA (continued indefinitely) and 75 mg of clopidogrel (for up to six months) [28][29][30][31][32][33][34][35].…”