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Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).
Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving transfemoral (TF) TAVI | TF TAVI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TF TAVI | Device | Follow-up Observation of patients having received a TF-TAVI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of early safety | Proportion of patients with early safety defined as:
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Cardiovascular death | Assessment of Cardiovascular death | 30 days |
| Assessment of Cardiovascular death | Assessment of Cardiovascular death |
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Inclusion Criteria:
Patients who meet all of the following conditions will be included:
Exclusion Criteria:
Patients who do not meet any of the following conditions:
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Patients undergoing scheduled transfemoral TAVI implantation, performed on an outpatient basis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario A Coruña | A Coruña | 15006 | Spain | |||
| Hospital General Universitario Dr. Balmis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30777842 | Background | Barbanti M, van Mourik MS, Spence MS, Iacovelli F, Martinelli GL, Muir DF, Saia F, Bortone AS, Densem CG, van der Kley F, Bramlage P, Vis M, Tamburino C. Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST-TAVI trial. EuroIntervention. 2019 Jun 20;15(2):147-154. doi: 10.4244/EIJ-D-18-01197. | |
| 29688322 |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D001024 | Aortic Valve Stenosis |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| 12 months |
| Assessment of Stroke | Incidence of patients with stroke diagnosed by a Neurologist according to VARC 3 criteria | 30 days |
| Assessment of Stroke | Incidence of patients with stroke diagnosed by a Neurologist according to VARC 3 criteria | 12 months |
| Assessment of Myocardial Infarction | Incidence of patients with Myocardial Infarction diagnosed by Cardiologist according to VARC 3 criteria | 30 days |
| Assessment of Myocardial Infarction | Incidence of patients with Myocardial Infarction diagnosed by Cardiologist according to VARC 3 criteria | 12 months |
| Assessment of Hospitalization for any reason | Incidence of patients with Hospitalization for any reason according to VARC 3 criteria | 30 days |
| Assessment of Hospitalization for any reason | Incidence of patients with Hospitalization for any reason according to VARC 3 criteria | 12 months |
| Assessments of Major Vascular Complications | Incidence of patients with Major Vascular Complications according to VARC 3 criteria | 30 days |
| Assessments of Major Vascular Complications | Incidence of patients with Major Vascular Complications according to VARC 3 criteria | 12 months |
| Assessments of need for pacemakers | Incidence of patients with need for pacemakers according to VARC 3 criteria | 30 days |
| Assessments of need for pacemakers | Incidence of patients with need for pacemakers according to VARC 3 criteria | 12 months |
| Assessment of hospitalization time | Incidence of patients with hospitalization according to VARC 3 criteria | at discharge |
| Assessment of hospitalization due cardiac reasons | Incidence of patients with hospitalization due cardiac reasons according to VARC 3 criteria | 12 months |
| Assessment of hospitalization due cardiac reasons | Incidence of patients with hospitalization due cardiac reasons according to VARC 3 criteria | 30 days |
| Alicante |
| 03010 |
| Spain |
| Hospital Clinico San Carlos | Aravaca | 28040 | Spain |
| Hospital Universitari Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hospital de Santa Creu I Sant Pau | Barcelona | 08025 | Spain |
| Hospital Universitari Vall Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat | 08907 | Spain |
| Hospital Regional Universitario de Malaga | Málaga | 29010 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33011 | Spain |
| Hospital Universitario de Navarra | Pamplona | 31008 | Spain |
| Hospital Clinico Universitario de Santiago | Santiago de Compostela | 15706 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| Hospital Universitari i Politècnic la Fe | Valencia | 46026 | Spain |
| Background |
| van Gils L, Baart S, Kroon H, Rahhab Z, El Faquir N, Rodriguez Olivares R, Aga Y, Maugenest AM, Theuns DA, Boersma E, Szili Torok T, De Jaegere PP, Van Mieghem NM. Conduction dynamics after transcatheter aortic valve implantation and implications for permanent pacemaker implantation and early discharge: the CONDUCT-study. Europace. 2018 Dec 1;20(12):1981-1988. doi: 10.1093/europace/euy074. |
| 28714522 | Background | Aldalati O, Keshavarzi F, Kaura A, Byrne J, Eskandari M, Deshpande R, Monaghan M, Wendler O, Dworakowski R, MacCarthy P. Factors associated with safe early discharge after transcatheter aortic valve implantation. Cardiol J. 2018;25(1):14-23. doi: 10.5603/CJ.a2017.0087. Epub 2017 Jul 17. |
| 27453514 | Background | Serletis-Bizios A, Durand E, Cellier G, Tron C, Bauer F, Glinel B, Dacher JN, Cribier A, Eltchaninoff H. A Prospective Analysis of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation. Am J Cardiol. 2016 Sep 15;118(6):866-872. doi: 10.1016/j.amjcard.2016.06.035. Epub 2016 Jun 27. |
| 27410958 | Background | Chandrasekhar J, Mehran R. Same or next day discharge: A new chapter in transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2016 Jan 1;87(1):143-4. doi: 10.1002/ccd.26388. |
| 30846085 | Background | Wood DA, Lauck SB, Cairns JA, Humphries KH, Cook R, Welsh R, Leipsic J, Genereux P, Moss R, Jue J, Blanke P, Cheung A, Ye J, Dvir D, Umedaly H, Klein R, Rondi K, Poulter R, Stub D, Barbanti M, Fahmy P, Htun N, Murdoch D, Prakash R, Barker M, Nickel K, Thakkar J, Sathananthan J, Tyrell B, Al-Qoofi F, Velianou JL, Natarajan MK, Wijeysundera HC, Radhakrishnan S, Horlick E, Osten M, Buller C, Peterson M, Asgar A, Palisaitis D, Masson JB, Kodali S, Nazif T, Thourani V, Babaliaros VC, Cohen DJ, Park JE, Leon MB, Webb JG. The Vancouver 3M (Multidisciplinary, Multimodality, But Minimalist) Clinical Pathway Facilitates Safe Next-Day Discharge Home at Low-, Medium-, and High-Volume Transfemoral Transcatheter Aortic Valve Replacement Centers: The 3M TAVR Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):459-469. doi: 10.1016/j.jcin.2018.12.020. |