TAVI, Transcatheter Valve Implantation
Conditions
Keywords
TAVI, PCI
Brief summary
Evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.
Detailed description
The increasing operator experience combined with an improved performance of devices have led to extend current transcatheter aortic valve implantation (TAVI) indications to patients at low or intermediate risk. The safety of TAVI in this population was initially tested in small observational studies and recently reported in the randomized PARTNER 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Trial (SURTAVI) trials, which demonstrated non- inferiority of TAVI in low or intermediate risk patients as compared to surgery with respect to the primary endpoint of death or disabling stroke. In view of the changes in the TAVI population, including younger patients with longer survival, the number of patients that may require coronary revascularization after TAVI is expected to increase over the time. Of note, challenges in performing percutaneous coronary interventions (PCI) in patients previously treated with TAVI have been reported in small series. Against this background, the purpose of this retrospective multicenter study is to evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI. Objectives 1. Evaluate the incidence of PCI after TAVI 2. Evaluate the clinical indications for PCI after TAVI 3. Evaluate the technical feasibility of PCI in patients with prior TAVI 4. Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI
Interventions
PROCEDUREPCI after TAVI
Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI
Sponsors
San Luigi Gonzaga Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the incidence of PCI after TAVI | up to 5 year after TAVI implantation | Evaluate the incidence of PCI after TAVI |
| Evaluate the clinical indications for PCI after TAVI | intraoperative | Clinical indication for PCI: stable angina; documented silent ischemia; acute coronary syndrome/non-ST elevation myocardial infarction; acute coronary syndrome/ST elevation myocardial infarction |
| Evaluate the technical feasibility of PCI in patients with prior TAVI | intraoperative | Successful target coronary vessel revascularization |
| Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI | up to 5 year after TAVI implantation | outcome defined as MACE (Major Adverse Coronary Event) a composite of Death, Myocardial Infarction, Target Lesion Failure |
Countries
Italy, Spain
Outcome results
None listed