| 000 | 04841nam a22005537a 4500 | ||
|---|---|---|---|
| 008 | 171017s20172017 xxu||||| |||| 00| 0 eng d | ||
| 040 | _aOvid MEDLINE(R) | ||
| 099 | _a28973520 | ||
| 245 | _aLongitudinal Hemodynamics of Transcatheter and Surgical Aortic Valves in the PARTNER Trial. | ||
| 251 | _aJAMA Cardiology. 2(11):1197-1206, 2017 11 01. | ||
| 252 | _aJAMA Cardiol. 2(11):1197-1206, 2017 11 01. | ||
| 253 | _aJAMA cardiology | ||
| 260 | _c2017 | ||
| 260 | _fFY2018 | ||
| 266 | _d2017-10-17 | ||
| 520 | _aConclusions and Relevance: This large, core laboratory-based study of transcatheter heart valves revealed excellent durability of the transcatheter heart valves and SAVR. Abnormal findings in individual patients, suggestive of valve thrombosis or structural deterioration, were rare in this protocol-driven database and require further investigation. | ||
| 520 | _aDesign, Setting, and Participants: In this study, we analyzed core laboratory-generated data from echocardiograms of all patients enrolled in the Placement of Aortic Transcatheter Valves (PARTNER) 1 Trial with successful TAVR or surgical AVR (SAVR) obtained preimplantation and at 7 days, 1 and 6 months, and 1, 2, 3, 4, and 5 years postimplantation. Patients from continued access observational studies were included for comparison. | ||
| 520 | _aImportance: Use of transcatheter aortic valve replacement (TAVR) for severe aortic stenosis is growing rapidly. However, to our knowledge, the durability of these prostheses is incompletely defined. | ||
| 520 | _aInterventions: Successful implantation after randomization to TAVR vs SAVR (PARTNER 1A; TAVR, n=321; SAVR, n=313), TAVR vs medical treatment (PARTNER 1B; TAVR, n=165), and continued access (TAVR, n=1996). Five-year echocardiogram data were available for 424 patients after TAVR and 49 after SAVR. | ||
| 520 | _aMain Outcomes and Measures: Death or reintervention for aortic valve structural indications, measured using aortic valve mean gradient, effective orifice area, Doppler velocity index, and evidence of hemodynamic deterioration by reintervention, adverse hemodynamics, or transvalvular regurgitation. | ||
| 520 | _aObjective: To determine the midterm hemodynamic performance of balloon-expandable transcatheter heart valves. | ||
| 520 | _aResults: Of 2795 included patients, the mean (SD) age was 84.5 (7.1) years, and 1313 (47.0%) were female. Population hemodynamic trends derived from nonlinear mixed-effects models showed small early favorable changes in the first few months post-TAVR, with a decrease of -2.9 mm Hg in aortic valve mean gradient, an increase of 0.028 in Doppler velocity index, and an increase of 0.09 cm2 in effective orifice area. There was relative stability at a median follow-up of 3.1 (maximum, 5) years. Moderate/severe transvalvular regurgitation was noted in 89 patients (3.7%) after TAVR and increased over time. Patients with SAVR showed no significant changes. In TAVR, death/reintervention was associated with lower ejection fraction, stroke volume index, and aortic valve mean gradient up to 3 years, with no association with Doppler velocity index or valve area. Reintervention occurred in 20 patients (0.8%) after TAVR and in 1 (0.3%) after SAVR and became less frequent over time. Reintervention was caused by structural deterioration of transcatheter heart valves in only 5 patients. Severely abnormal hemodynamics on echocardiograms were also infrequent and not associated with excess death or reintervention for either TAVR or SAVR. | ||
| 520 | _aTrial Registration: clinicaltrials.gov Identifier: NCT00530894. | ||
| 546 | _aEnglish | ||
| 650 | _a*Aortic Valve Stenosis/su [Surgery] | ||
| 650 | _a*Aortic Valve/su [Surgery] | ||
| 650 | _a*Bioprosthesis | ||
| 650 | _a*Heart Valve Prosthesis | ||
| 650 | _a*Hemodynamics | ||
| 650 | _a*Transcatheter Aortic Valve Replacement/mt [Methods] | ||
| 650 | _aAged | ||
| 650 | _aAged, 80 and over | ||
| 650 | _aAortic Valve/dg [Diagnostic Imaging] | ||
| 650 | _aBlood Flow Velocity | ||
| 650 | _aEchocardiography | ||
| 650 | _aFemale | ||
| 650 | _aHeart Valve Prosthesis Implantation/mt [Methods] | ||
| 650 | _aHumans | ||
| 650 | _aLongitudinal Studies | ||
| 650 | _aMale | ||
| 650 | _aReoperation | ||
| 650 | _aStroke Volume | ||
| 651 | _aMedStar Heart & Vascular Institute | ||
| 657 | _aJournal Article | ||
| 700 | _aWeissman, Neil J | ||
| 790 | _aAlu MC, Blackstone EH, Douglas PS, Finn MT, Hahn RT, Herrmann HC, Kapadia S, Kodali SK, Leon MB, Lerakis S, Lowry AM, Mack MJ, Makkar RR, Miller DC, PARTNER Trial Investigators, Pibarot P, Rajeswaran J, Smith CR, Svensson LG, Thourani VH, Webb JG, Weissman NJ | ||
| 856 |
_uhttps://dx.doi.org/10.1001/jamacardio.2017.3306 _zhttps://dx.doi.org/10.1001/jamacardio.2017.3306 |
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| 942 |
_cART _dArticle |
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| 999 |
_c2768 _d2768 |
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