دورية أكاديمية
Safety and feasibility of early discharge after transcatheter aortic valve implantation with ACURATE Neo-the POLESTAR trial.
| العنوان: | Safety and feasibility of early discharge after transcatheter aortic valve implantation with ACURATE Neo-the POLESTAR trial. |
|---|---|
| المؤلفون: | Ooms JF; Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands., Cornelis K; AZ Maria Middelares, Ghent, Belgium., Wijeysundera HC; Sunnybrook Health Sciences Centre, Toronto, ON, Canada., Vandeloo B; University Hospital Brussels, Brussels, Belgium., Van Der Heyden J; Sint Jan Hospital, Brugge, Belgium., Kovac J; University Hospitals Leicester NHS Trust, Leicester, UK., Wood D; Centre for Heart Valve Innovation, St. Paul's Hospital, University of British Columbia, Vancouver, BC, Canada., Chan A; Royal Columbian Hospital, New Westminster, BC, Canada., Wykyrzykowska J; University Medical Center Groningen, Groningen, The Netherlands., Rosseel L; ASZ Aalst, Aalst, Belgium., Cunnington M; Leeds Teaching Hospitals NHS Trust, Leeds, UK., van der Kley F; Leiden University Medical Center, Leiden, The Netherlands., Rensing B; Sint Antonius Hospital, Nieuwegein, The Netherlands., Voskuil M; University Medical Center Utrecht, Utrecht, The Netherlands., Hildick-Smith D; University Hospitals Brighton and Sussex NHS Trust, Brighton, UK., Van Mieghem NM; Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands. n.vanmieghem@erasmusmc.nl. |
| المصدر: | Clinical research in cardiology : official journal of the German Cardiac Society [Clin Res Cardiol] 2024 Apr 15. Date of Electronic Publication: 2024 Apr 15. |
| Publication Model: | Ahead of Print |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Country of Publication: Germany NLM ID: 101264123 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1861-0692 (Electronic) Linking ISSN: 18610684 NLM ISO Abbreviation: Clin Res Cardiol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Aug. 2007- : Heidelberg, Germany : Springer Medizin Original Publication: Darmstadt, Germany : Springer Medizin, [2006]- |
| مستخلص: | Background: Transcatheter aortic valve implantation (TAVI) serves a growing range of patients with severe aortic stenosis (AS). TAVI has evolved to a streamlined procedure minimizing length of hospital stay. Aims: To evaluate the safety and efficacy of an early discharge (ED) strategy after TAVI. Methods: We performed an international, multi-center, prospective observational single-arm study in AS patients undergoing TAVI with the ACURATE valve platform. Eligibility for ED was assessed prior to TAVI and based on prespecified selection criteria. Discharge ≤ 48 h was defined as ED. Primary Valve Academic Research Consortium (VARC)-3-defined 30-day safety and efficacy composite endpoints were landmarked at 48 h and compared between ED and non-ED groups. Results: A total of 252 patients were included. The median age was 82 [25th-75th percentile, 78-85] years and the median Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 2.2% [25th-75th percentile, 1.6-3.3]. ED and non-ED were achieved in 173 (69%) and 79 (31%) patients respectively. Monitoring for conduction disturbances was the principal reason for non-ED (33%). Overall, at 30 days, all-cause mortality was 1%, new permanent pacemaker rate was 4%, and valve- or procedure-related rehospitalization was 4%. There was no difference in the primary safety and efficacy endpoint between the ED and non-ED cohorts (OR 0.84 [25th-75th percentile, 0.31-2.26], p = 0.73, and OR 0.97 [25th-75th percentile, 0.46-2.06], p = 0.94). The need for rehospitalization was similarly low for ED and non-ED groups. Conclusion: Early discharge after TAVI with the ACURATE valve is safe and feasible in selected patients. Rhythm monitoring and extended clinical observation protracted hospital stay. (© 2024. The Author(s).) |
| References: | Cribier A (2012) Development of transcatheter aortic valve implantation (TAVI): a 20-year odyssey. Arch Cardiovasc Dis 105:146–152. (PMID: 10.1016/j.acvd.2012.01.00522520797) Barbanti M, Buccheri S, Rodes-Cabau J et al (2017) Transcatheter aortic valve replacement with new-generation devices: a systematic review and meta-analysis. Int J Cardiol 245:83–89. (PMID: 10.1016/j.ijcard.2017.07.08328760396) Costa G, Barbanti M, Rosato S et al (2022) Real-world multiple comparison of transcatheter aortic valves: insights from the multicenter OBSERVANT II study. Circ Cardiovasc Interv 15:e012294. (PMID: 10.1161/CIRCINTERVENTIONS.122.01229436484239) Villablanca PA, Mohananey D, Nikolic K et al (2018) Comparison of local versus general anesthesia in patients undergoing transcatheter aortic valve replacement: a meta-analysis. Catheter Cardiovasc Interv 91:330–342. (PMID: 10.1002/ccd.2720728738447) Winter MP, Bartko P, Hofer F et al (2020) Evolution of outcome and complications in TAVR: a meta-analysis of observational and randomized studies. Sci Rep 10:15568. (PMID: 10.1038/s41598-020-72453-1329681047511292) Babaliaros V, Devireddy C, Lerakis S et al (2014) Comparison of transfemoral transcatheter aortic valve replacement performed in the catheterization laboratory (minimalist approach) versus hybrid operating room (standard approach): outcomes and cost analysis. JACC Cardiovasc Interv 7:898–904. (PMID: 10.1016/j.jcin.2014.04.00525086843) Didier R, Le Breton H, Eltchaninoff H et al (2022) Evolution of TAVI patients and techniques over the past decade: the French TAVI registries. Arch Cardiovasc Dis 115:206–213. (PMID: 10.1016/j.acvd.2022.04.00435527212) Arora S, Strassle PD, Kolte D et al (2018) Length of stay and discharge disposition after transcatheter versus surgical aortic valve replacement in the United States. Circ Cardiovasc Interv 11:e006929. (PMID: 10.1161/CIRCINTERVENTIONS.118.00692930354596) Wayangankar SA, Elgendy IY, Xiang Q et al (2019) Length of stay after transfemoral transcatheter aortic valve replacement: an analysis of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. JACC Cardiovasc Interv 12:422–430. (PMID: 10.1016/j.jcin.2018.11.01530846079) Barbanti M, van Mourik MS, Spence MS et al (2019) Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST-TAVI trial. EuroIntervention 15:147–154. (PMID: 10.4244/EIJ-D-18-0119730777842) Wood DA, Lauck SB, Cairns JA et al (2019) 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 12:459–469. (PMID: 10.1016/j.jcin.2018.12.02030846085) Hokken TW, Muhemin M, Okuno T et al (2022) Impact of membranous septum length on pacemaker need with different transcatheter aortic valve replacement systems: the INTERSECT registry. J Cardiovasc Comput Tomogr 16:524–530. (PMID: 10.1016/j.jcct.2022.07.00335872136) Ooms JF, Cornelis K, Stella PR et al (2022) Rationale and design of the project to look for early discharge in patients undergoing TAVR with ACURATE (POLESTAR Trial). Cardiovasc Revasc Med 44:71–77. (PMID: 10.1016/j.carrev.2022.06.00935739011) Varc Writing C, Genereux P, Piazza N et al (2021) Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. J Am Coll Cardiol 77:2717–2746. (PMID: 10.1016/j.jacc.2021.02.038) Barker M, Sathananthan J, Perdoncin E et al (2022) Same-day discharge post-transcatheter aortic valve replacement during the COVID-19 pandemic: the multicenter PROTECT TAVR study. JACC Cardiovasc Interv 15:590–598. (PMID: 10.1016/j.jcin.2021.12.046353314508936029) Kamioka N, Wells J, Keegan P et al (2018) Predictors and clinical outcomes of next-day discharge after minimalist transfemoral transcatheter aortic valve replacement. JACC Cardiovasc Interv 11:107–115. (PMID: 10.1016/j.jcin.2017.10.02129348004) Krishnaswamy A, Isogai T, Agrawal A et al (2022) Feasibility and safety of same-day discharge following transfemoral transcatheter aortic valve replacement. JACC Cardiovasc Interv 15:575–589. (PMID: 10.1016/j.jcin.2022.01.01335331449) Scotti A, Pagnesi M, Kim WK et al (2022) Haemodynamic performance and clinical outcomes of transcatheter aortic valve replacement with the self-expanding ACURATE neo2. EuroIntervention 18:804–811. (PMID: 10.4244/EIJ-D-22-00289356782229725034) Elzanaty AM, Maraey A, Elbadawi A et al (2022) Early versus late discharge after transcatheter aortic valve replacement and readmissions for permanent pacemaker implantation. Catheter Cardiovasc Interv 100:245–253. (PMID: 10.1002/ccd.3029935758231) Leon MB, Smith CR, Mack MJ et al (2016) Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 374:1609–1620. (PMID: 10.1056/NEJMoa151461627040324) Manoharan G, Grube E, Van Mieghem NM et al (2020) Thirty-day clinical outcomes of the Evolut PRO self-expanding transcatheter aortic valve: the international FORWARD PRO study. EuroIntervention 16:850–857. (PMID: 10.4244/EIJ-D-20-0027932748789) Reardon MJ, Van Mieghem NM, Popma JJ et al (2017) Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med 376:1321–1331. (PMID: 10.1056/NEJMoa170045628304219) Mack MJ, Leon MB, Thourani VH et al (2019) Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 380:1695–1705. (PMID: 10.1056/NEJMoa181405230883058) Popma JJ, Deeb GM, Yakubov SJ et al (2019) Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med 380:1706–1715. (PMID: 10.1056/NEJMoa181688530883053) |
| فهرسة مساهمة: | Keywords: Early discharge; Self-expanding valve; TAVI |
| تواريخ الأحداث: | Date Created: 20240415 Latest Revision: 20240415 |
| رمز التحديث: | 20240415 |
| DOI: | 10.1007/s00392-024-02436-z |
| PMID: | 38619575 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 1861-0692 |
|---|---|
| DOI: | 10.1007/s00392-024-02436-z |