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Single-center evalu...
Single-center evaluation of a next generation fully repositionable and retrievable transcatheter aortic valve replacement
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- Berntorp, Karolina (författare)
- Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital
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- Koul, Sasha (författare)
- Lund University,Lunds universitet,Molekylär kardiologi,Forskargrupper vid Lunds universitet,Molecular Cardiology,Lund University Research Groups,Skåne University Hospital
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- Nozohoor, Shahab (författare)
- Lund University,Lunds universitet,Minimalinvasiv hjärtkirurgi vid hjärtklaffsjukdom,Forskargrupper vid Lunds universitet,Minimal invasive cardiac surgery in valvular heart disease,Lund University Research Groups,Skåne University Hospital
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- Harnek, Jan (författare)
- Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital
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- Bjursten, Henrik (författare)
- Lund University,Lunds universitet,Skonsammare hjärtkirurgi,Forskargrupper vid Lunds universitet,Less invasive cardiac surgery,Lund University Research Groups,Skåne University Hospital
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- Götberg, Matthias (författare)
- Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital
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(creator_code:org_t)
- 2019-02-26
- 2019
- Engelska.
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Ingår i: BMC Cardiovascular Disorders. - : Springer Science and Business Media LLC. - 1471-2261. ; 19:1
- Relaterad länk:
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http://dx.doi.org/10... (free)
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https://bmccardiovas...
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Background: The mechanically expandable Lotus Valve System is a fully repositionable and retrievable valve with an adaptive seal to minimize paravalvular leak (PVL). The aim of this study was to evaluate the short- and long-term safety and efficacy of the new device with focus on a new implantation technique to reduce the need for a permanent pacemaker (PPM) post procedure. Methods: We performed a prospective single-center, non-randomized evaluation of the Lotus Valve System. The first 100 consecutive Lotus Valve implantations were included in the analysis. Outcome was assessed according to VARC2-criteria. Postoperative pacemaker rates were assessed using the national pacemaker registry and electronic medical records. Mortality at 30 days and 12 months were acquired from the national population registry. Results: Mean age was 82.7 ± 5.6 years, mean Euroscore I was 25.3 ± 14.5%, mean STS-score was 6.5 ± 4.1% and mean aortic valve area was 0.6 ± 0.1 cm 2 . There were no cases of valve embolization, ectopic valve deployment or additional valve implantation. Device success according to the VARC2-criteria was 97%. The 30-day mortality rate was 3%. Two deaths occurred due to stroke and one due to a ventricular rupture. Major stroke rate was 2% and major vascular complication rate was 2%. The 12-month mortality rate was 14%. At discharge 87% of patients had no/trace PVL, 12% had mild PVL and one patient had a moderate PVL. A total of 13% received a new PPM post valve implantation. Among patients who did not have a PPM before the procedure, the PPM rate was 15.3%. Conclusions: This single-center evaluation of the Lotus Valve System demonstrated a good clinical outcome with a low mortality, in a high-risk population. Introduction of a new implantation technique resulted in lower PPM rates than previously reported without negatively affecting PVL. Trial registration: Current Controlled Trials ISRCTN14952278, retrospectively registered 06/11/2017.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
- TEKNIK OCH TEKNOLOGIER -- Medicinteknik -- Medicinsk apparatteknik (hsv//swe)
- ENGINEERING AND TECHNOLOGY -- Medical Engineering -- Medical Equipment Engineering (hsv//eng)
Nyckelord
- Paravalvular leak
- Permanent pacemaker
- Transcatheter aortic valve replacement
Publikations- och innehållstyp
- art (ämneskategori)
- ref (ämneskategori)
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