This study aimed to compare the hemodynamic performance of transcatheter and surgical aortic valves in patients with severe symptomatic aortic stenosis and small aortic annulus (SAA) and to determine the valve hemodynamics according to transcatheter valve type. Consecutive surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) patients with SAA were case-matched (1:1) on the basis of sex, body surface area, aortic annulus diameter, and left ventricular ejection fraction. A total of 357 patients in each group constituted the final study population. A second match on the basis of aortic annulus diameter and valve/annulus calcium burden was performed within the TAVR group to compare the valve performance between balloon- (n = 52) and selfexpanding (n = 52) transcatheter valve systems (BEV, SEV). The echocardiograms performed at hospital discharge were used for evaluating valve hemodynamics. The mean annulus diameter of the study population was 19.2 +/- 0.3 mm. The TAVR group (vs SAVR) exhibited lower mean gradient (12 +/- 7 mm Hg vs 15 +/- 6 mm Hg, p <0.001), larger effective orifice area (1.46 +/- 0.39 cm(2) vs 1.25 +/- 0.37 cm(2), p <0.001) and a lower rate of severe prosthesis-patient mismatch (PPM) (14% vs 24%, p = 0.001). Moderate-severe AR was present in 2.5% of the TAVR recipients versus none patient in the SAVR group. There were no differences in valve hemodynamics between balloon-expanding transcatheter valve system and self-expanding transcatheter valve system, and similar rates of severe PPM were observed in both groups (p = 0.488). In conclusion, TAVR presented superior valve hemodynamics and lower incidence of severe PPM compared with SAVR in SAA patients. Similar valve performance results were observed between transcatheter valve types. (C) 2019 Elsevier Inc. All rights reserved.
Abstract Objective To evaluate very long-term survival of Total Arterial Revascularization (TAR) in patients with severe coronary artery disease (CAD) undergoing Coronary Artery Bypass Grafting (CABG). Methods Between January 1992 and December 2017, 13798 patients aged 70 years or less underwent primary isolated CABG with at least two grafts in our department. Patients receiving TAR were matched by propensity-score analysis to the rest of the population. All pre- and peri-operative data were collected prospectively in our institutional database. Long-term survival was assessed using provincial vital statistics data. The primary outcome was very-long time survival, secondary outcomes were operative mortality and early complications. Results Propensity-score matching identified 602 pairs with similar preoperative characteristics. In the matched control group, 65.4% and 30.9% of patients received 1 and 2 arterial grafts, respectively, whereas 3 or more arterial grafts were used in 3.6%. Less distal anastomoses (2.57±0.77 vs 3.39±0.97, p<0.0001) were performed in TAR patients, who therefore had a shorter cross-clamping time (44.2±14.7 vs 52.9±19.6, p<0.0001). Operative mortality was similar (0.5% vs 1.0%, p=0.51) and there was no difference in the rate of mediastinitis (2.5% vs 0.8%, p=0.28)for the TAR and matched control groups, respectively. TAR patients were less likely to receive blood transfusions (34.9% vs 40.7%, p=0.04). The average follow-up was 13.4±6.7 years. Cox-adjusted survival was significantly better in patients receiving TAR compared to the matched population, up to 25 years postoperatively (HR 0.87 [0.86–0.88], p<0.0001, Figure 1). Figure 1 Conclusion Total arterial revascularization is not associated with increased perioperative risk of complications and provides long-term survival benefits up to 25 years postoperatively.
BackgroundSignificant mitral regurgitation (MR) is associated with poorer outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). Factors associated with MR improvement have not been studied thoroughly.MethodsRetrospective analysis of consecutive patients treated with TAVR with more than mild MR at baseline. MR evolution was assessed at 1–3 and 6–12 months after intervention. MR severity and mechanisms were assessed by echocardiography. Mitral annulus calcification (MAC) was quantified using preoperative cardiac CT.ResultsFrom 674 consecutive TAVR recipients, 78 with more than mild MR had a 6–12 months follow‐up. Following TAVR, MR improved in 34 patients (43%), remained stable in 38 (49%) and worsened in 6 (8%). Patients with MR improvement had greater tenting area (141 ± 56 vs. 99 ± 40 mm2, P < 0.01), tenting height (7.2 ± 1.9 vs. 5.6 ± 1.9 mm, P < 0.01) and lower ejection fraction (43 ± 16 vs. 52 ± 14%, P = 0.01). MAC was frequent (87.7% of patients) and a trend in greater MAC was observed in patients without MR improvement (3560 ± 5587 vs. 2053 ± 2800, P = 0.16). In multivariable analysis, tenting area (OR per 10 mm2 increase: 1.012, 95% CI, 1.001–1.024 P = 0.039) and annulus calcifications associated with leaflet restriction (OR = 0.108, 95% CI, 0.012–0.956, P = 0.045) were independently associated with MR outcome after TAVR.ConclusionLarger mitral valve tenting area was associated with more improvement of MR after TAVR whereas extensive MAC associated with leaflet restriction was associated with less improvement. This may help in the clinical decision‐making process of TAVR candidates with concomitant MR.
Background and objectives Transcatheter aortic valve-in-valve implantation (ViV) has emerged as a valuable technique to treat failed surgical bioprostheses (BPs) in patients with high risk for redo surgical aortic valve replacement (SAVR). Small BP size (≤21 mm), stenotic pattern of degeneration and pre-existing prosthesis–patient mismatch (PPM) have been associated with worse clinical outcomes after ViV. However, no study has evaluated the actual haemodynamic benefit associated with ViV. This study aims to compare haemodynamic status observed at post-ViV, pre-ViV and early after initial SAVR and to determine the factors associated with worse haemodynamic outcomes following ViV, including the rates of high residual gradient and ‘haemodynamic futility’. Methods Early post-SAVR, pre-ViV and post-ViV echocardiographic data of 79 consecutive patients who underwent aortic ViV at our institution were retrospectively analysed. The primary study endpoint was suboptimal valve haemodynamics (SVH) following ViV defined by the Valve Academic Research Consortium 2 as the presence of high residual aortic mean gradient (≥20 mm Hg) and/or at least moderate aortic regurgitation (AR). Haemodynamic futility of ViV was defined as <10 mm Hg decrease in mean aortic gradient and no improvement in AR compared with pre-ViV. Results SVH was found in 61% of patients (57% high residual gradient, 4% moderate AR) after ViV versus 24% early after SAVR. Pre-existing PPM and BP mode of failure by stenosis were independently associated with the primary endpoint (OR: 2.87; 95% CI 1.08 to 7.65; p=0.035 and OR: 3.02; 95% CI 1.08 to 8.42; p=0.035, respectively) and with the presence of high residual gradient (OR: 4.38; 95% CI 1.55 to 12.37; p=0.005 and OR: 5.37; 95% CI 1.77 to 16.30; p=0.003, respectively) following ViV. Criteria of ViV haemodynamic futility were met in 7.6% overall and more frequently in patients with pre-existing PPM and stenotic BP (18.5%) compared with other patients (2.0%). ViV restored haemodynamic function to early post-SAVR level in only 34% of patients. Conclusion Although ViV was associated with significant haemodynamic improvement compared with pre-ViV in >90% of patients, more than half harboured SVH outcome. Furthermore, only one-third of patients had a restoration of valve haemodynamic function to the early post-SAVR level. Pre-existing PPM and stenosis pattern of BP degeneration were the main factors associated with SVH and haemodynamic futility following ViV. These findings provide strong support for the prevention of PPM at the time of initial SAVR and careful preprocedural patient screening.
The transcarotid (TC) approach has recently been suggested as an alternative means of obtaining arterial access during transcatheter aortic valve replacement (TAVR) in patients who do not harbor favorable femoral arterial anatomy [(1–3)][1]. Preliminary data have suggested the absence of an
Background The optimal access for patients undergoing transcatheter aortic valve replacement (TAVR) who are not candidates for a transfemoral approach has not been elucidated. The purpose of this study was to compare the safety, feasibility, and early clinical outcomes of transcarotid TAVR compared with thoracic approaches. Methods and Results From a multicenter consecutive cohort of 329 alternative-access TAVR patients (2012–2017), we identified 101 patients who underwent transcarotid TAVR and 228 patients who underwent a transapical or transaortic TAVR. Preprocedural success and 30-day clinical outcomes were compared using multivariable propensity score analysis to account for between-group differences in baseline characteristics. All transcarotid cases were performed under general anesthesia, mainly using the left common carotid artery (97%). Propensity-matched groups had similar rates of 30-day all-cause mortality (2.1% versus 4.6%; P =0.37), stroke (2.1% versus 3.5%; P =0.67; transcarotid versus transapical/transaortic, respectively), new pacemaker implantation, and major vascular complications. Transcarotid TAVR was associated with significantly less new-onset atrial fibrillation (3.2% versus 19.0%; P =0.002), major or life-threatening bleeding (4.3% versus 19.9%; P =0.002), acute kidney injury (none versus 12.1%; P =0.002), and shorter median length of hospital stay (6 versus 8 days; P <0.001). Conclusions Transcarotid vascular access for TAVR is safe and feasible and is associated with encouraging short-term clinical outcomes. Our data suggest a clinical benefit of transcarotid TAVR with respect to atrial fibrillation, major bleeding, acute kidney injury, and length of stay compared with the more invasive transapical or transaortic strategies. Randomized studies are required to ascertain whether transcarotid TAVR yields equivalent results to other alternative vascular access routes.
Transcatheter aortic valve replacement (TAVR) is being increasingly used for the treatment of severe native aortic valve stenosis. Initially performed in patients with prohibitive or high surgical risk, TAVR is now considered as a valid alternative in patients with intermediate risk and is being
Central MessageOur case report describes a potentially lethal subacute transcatheter mitral valve dysfunction. We report the successful management of an overhanging native mitral leaflet after TMVR.See Editorial Commentary page e173. Our case report describes a potentially lethal subacute transcatheter mitral valve dysfunction. We report the successful management of an overhanging native mitral leaflet after TMVR. See Editorial Commentary page e173. Severe aortic regurgitation is the indication to perform valve-in-valve implantation in almost all patients with previous transcatheter aortic valve replacement (TAVR), but few data are available on the incidence and mechanisms of acute severe central mitral regurgitation (MR) after transcatheter mitral valve replacement (TMVR). We report the occurrence of severe transcatheter heart valve (THV) leaflet malfunction after TMVR inside a calcified native mitral valve. An overhanging native mitral leaflet was seen, precluding appropriate closing of the THV. To our knowledge, this is the first description of an overhanging native mitral valve leaflet precluding proper function of a mitral THV implanted within a calcified native mitral valve. A 76-year-old woman with a history of previous surgical aortic valve replacement with a 21-mm Sorin Mitroflow prosthesis (Sorin Group Inc, Milan, Italy) and previous coronary artery bypass graft surgery was referred to our institution with severe shortness of breath (New York Heart Association functional class 4). Her medical history was also significant for hypertension, hyperlipidemia, type II diabetes mellitus, morbid obesity, and moderate chronic kidney disease (baseline creatinine clearance of 46 mL/min). Transesophageal echocardiography showed a left ventricular ejection fraction of 50%, a left ventricular outflow tract diameter of 20 mm, a failed aortic bioprosthesis (moderate to severe stenosis with peak and mean gradients of 47 mm Hg and 22 mm Hg, respectively, combined with moderate regurgitation), severely calcified degenerative mitral stenosis (mitral valve area of 0.96 cm2, with peak and mean gradients of 22 mm Hg and 8 mm Hg, respectively) and moderate degenerative mitral regurgitation (Figure 1, A, and Video 1). The native anterior mitral valve leaflet was calcified, and its length was 22 mm. Cardiac computed tomography revealed an aortic annular area of the bioprosthetic valve measured at 299 mm2 (stent internal diameter of 20.7 × 18.2 mm and true theoretic internal diameter of 17.3 mm; Figure 1, B). Cardiac computed tomography demonstrated a circumferential calcification of the native mitral annulus and a mitral annular area of 650 mm2 (mean diameter of 28.7 mm; Figure 1, C). The patient was deemed not to be a surgical candidate by the heart team because of frailty and significant comorbidities (euroSCORE II of 47%). Recent studies have shown the feasibility and effectiveness of transcatheter aortic valve-in-valve procedures1Webb J.G. Mack M.J. White J.M. Dvir D. Blanke P. Herrmann H.C. et al.Transcatheter aortic valve implantation within degenerated aortic surgical bioprostheses: PARTNER 2 valve-in-valve registry.J Am Coll Cardiol. 2017; 69: 2253-2262Crossref PubMed Scopus (227) Google Scholar, 2Dvir D. Webb J.G. Bleiziffer S. Pasic M. Waksman R. Kodali S. et al.Valve-in-Valve International Data Registry InvestigatorsTranscatheter aortic valve implantation in failed bioprosthetic surgical valves.JAMA. 2014; 312: 162-170Crossref PubMed Scopus (665) Google Scholar as well as TMVR with balloon-expandable valves in patients with severe mitral annular calcification.3Guerrero M. Dvir D. Himbert D. Urena M. Eleid M. Wang D.D. et al.Transcatheter mitral valve replacement in native mitral valve disease with severe mitral annular calcification: results from the first multicenter global registry.JACC Cardiovasc Interv. 2016; 9: 1361-1371Crossref PubMed Scopus (220) Google ScholarFigure 1Transcatheter aortic valve-in-valve replacement and transcatheter mitral valve replacement. A, Severe aortic bioprosthesis stenosis and severe mitral disease demonstrated on transesophageal echocardiogram (Video 1). B and C, Cardiac computed tomography revealed a severely calcified aortic bioprosthetic valve with internal diameters of 18.2 mm × 20.7 mm (area of 299 mm2; B) and circumferential calcification of the native mitral annulus (C). D, Deployment of a SAPIEN XT (Edwards Lifesciences, Irvine, Calif) 23-mm transcatheter heart valve in the aortic position (Video 2) and a SAPIEN XT 29-mm valve with marked dog-bone effect during inflation of the transcatheter heart valve in the mitral position (Video 3).View Large Image Figure ViewerDownload Hi-res image Download (PPT) Our heart team, composed of cardiovascular surgeons, interventional cardiologists and echocardiographers, decided to proceed with concomitant valve-in-valve TAVR combined with TMVR through a transapical approach. The patient was brought to our hybrid surgical room. A standard transapical access was obtained. Under transesophageal echocardiographic and fluoroscopic guidance, a SAPIEN XT 23-mm valve (Edwards Lifesciences, Irvine, Calif) was successfully deployed inside the Sorin Mitroflow 21-mm valve in the aortic position (postprocedural peak and mean gradients of 33 and 18 mm Hg; Video 2). Afterward, a stiff wire was placed across the mitral valve and positioned inside a pulmonary vein. A balloon valvuloplasty was performed. A SAPIEN XT 29-mm prosthesis was then firmly advanced across the very calcified native mitral valve. The deployment of the mitral transcatheter heart valve was done under rapid ventricular pacing. Moreover, to guide positioning, we used the dog-bone effect (Video 3) created by a very slow inflation of the balloon on which the THV was crimped (Figure 1, D, and Video 3).Video 3Fluoroscopic imaging showing deployment of a SAPIEN XT (Edwards Lifesciences, Irvine, Calif) 29-mm valve transcatheter heart valve within the calcified native mitral valve. Video available at: http://www.jtcvsonline.org/article/S0022-5223(18)30037-0/fulltext.View Large Image Figure ViewerDownload Hi-res image Download (PPT) Postprocedural transesophageal echocardiography showed mild to moderate paravalvular leak (Figure 2, A, and Video 4). There was no central MR, no significant gradient across the new THV, and no left ventricular outflow tract obstruction. The patient was subsequently transferred to the surgical intensive care unit. Three hours later, the patient developed severe cardiogenic shock as a result of a TMVR leaflet malfunction (Figure 2, B, and Video 5), leading to the new onset of severe central MR (Figure 2, C, and Videos 6 and 7). The heart team elected to proceed with an urgent mitral valve-in-valve replacement with another SAPIEN XT 29-mm prosthesis through the same transapical access (Figure 2, D, and Video 8). Immediate resolution of the central MR (Video 9) led to major improvement of the hemodynamic parameters and weaning of vasopressors. Thirteen days later, cardiac magnetic resonance imaging was performed and showed mild to moderate paravalvular regurgitation without any central MR. Clinical progress was favorable, and the patient was discharged home on postoperative day 15.Video 5Transesophageal echocardiogram showing transcatheter mitral valve dysfunction. Video available at: http://www.jtcvsonline.org/article/S0022-5223(18)30037-0/fulltext.View Large Image Figure ViewerDownload Hi-res image Download (PPT)Video 6Transesophageal echocardiogram with color Doppler showing severe central mitral regurgitation. Video available at: http://www.jtcvsonline.org/article/S0022-5223(18)30037-0/fulltext.View Large Image Figure ViewerDownload Hi-res image Download (PPT)Video 7Transesophageal echocardiogram demonstrating a native overhanging mitral valve leaflet. Video available at: http://www.jtcvsonline.org/article/S0022-5223(18)30037-0/fulltext.View Large Image Figure ViewerDownload Hi-res image Download (PPT)Video 8Fluoroscopic imaging showing deployment of a SAPIEN XT (Edwards Lifesciences, Irvine, Calif) 29-mm valve in a more ventricular position. Video available at: http://www.jtcvsonline.org/article/S0022-5223(18)30037-0/fulltext.View Large Image Figure ViewerDownload Hi-res image Download (PPT)Video 9Transesophageal echocardiogram with color Doppler showing minimal mitral regurgitation after the mitral valve-in-valve procedure. Video available at: http://www.jtcvsonline.org/article/S0022-5223(18)30037-0/fulltext.View Large Image Figure ViewerDownload Hi-res image Download (PPT)Figure 2Overhanging native mitral valve leaflet and urgent transcatheter mitral valve-in-valve replacement. A, Mild to moderate paravalvular leak immediately after the procedure can be seen on transesophageal echocardiography (Video 4). B, Mitral transcatheter heart valve leaflet malfunction causing severe mitral regurgitation, leading to cardiogenic shock (Videos 5 and 6). C, Native overhanging mitral valve leaflet demonstrated on transesophageal echocardiogram (Video 7). D, Deployment of a SAPIEN XT (Edwards Lifesciences, Irvine, Calif) 29-mm valve in a more ventricular position (Video 8) led to immediate resolution of the central mitral regurgitation with favorable outcomes (Video 9).View Large Image Figure ViewerDownload Hi-res image Download (PPT) In patients with recently implanted aortic THV, severe aortic regurgitation is the indication to perform valve-in-valve implantation in 97% of cases.4Makkar R.R. Jilaihawi H. Chakravarty T. Fontana G.P. Kapadia S. Babaliaros V. et al.Determinants and outcomes of acute transcatheter valve-in-valve therapy or embolization: a study of multiple valve implants in the U.S. PARTNER trial (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve).J Am Coll Cardiol. 2013; 62: 418-430Crossref PubMed Scopus (121) Google Scholar Among those patients, the etiology of AR may be leaflet malfunction caused by calcium impingement, leaflet overhang, postdilation disruption of the architecture of the bioprosthesis, insufficient aortic pressure to close the leaflets of the TAVR, a tilted or canted valve, or aortic cusp rupture.5Summers M.R. Cremer P.C. Jaber W.A. Three mechanisms of early failure of transcatheter aortic valves: valve thrombosis, cusp rupture, and accelerated calcification.J Thorac Cardiovasc Surg. 2017; 153: e87-e93Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar In contrast, very sparse data are available on the incidence and the mechanisms of acute severe central MR after TMVR. We report the occurrence of severe THV leaflet malfunction after TMVR inside a calcified native mitral valve. In retrospect, an overhanging native mitral leaflet was seen to preclude the appropriate closing of the TMVR. This was probably caused by the relatively high auricular position of the first transcatheter mitral valve. Deployment of a second transcatheter valve in a more ventricular position resolved the acute mitral regurgitation by preventing protrusion of the calcified native anterior mitral leaflet underneath the mitral transcatheter valve. This demonstrates that valve positioning during TMVR is crucial to minimize the risk of left ventricular outflow tract obstruction, the risk of paravalvular leak, and possibly the risk of static or dynamic overhanging mitral leaflet. In our case, initial periprocedural success mitigates the possibility of a transcatheter leaflet damage or a disruption of the native mitral leaflets after balloon valvuloplasty. In summary, this case report is, to our knowledge, the first description of an overhanging native mitral valve leaflet precluding proper function of a mitral THV implanted within a calcified native mitral valve. Further studies will be needed to determine the nature, determinants, and outcomes of acute, subacute, and late THV malfunction after TMVR inside native mitral valves, as well as within failing mitral surgical bioprostheses and rings. In our opinion, this case illustrates the importance of case reports in advancing medical scientific knowledge of rare complications. eyJraWQiOiI4ZjUxYWNhY2IzYjhiNjNlNzFlYmIzYWFmYTU5NmZmYyIsImFsZyI6IlJTMjU2In0.eyJzdWIiOiI1NWQyMTZjNTA5ZWU3NTFjNjgyZWYxMzYwY2RlNTA3YyIsImtpZCI6IjhmNTFhY2FjYjNiOGI2M2U3MWViYjNhYWZhNTk2ZmZjIiwiZXhwIjoxNjc4NTA5OTI1fQ.K8NmPwfD_59lZLxvhgaWetrsCsysZ52A2JAmrj_6fsmryIADMpW49R6MMRGFQaOlG9IaTlniYraf1_zdrDKhOGnSvVYndU7R1xf6D0skRRdhLq8NQ70yT3coT8rTj43MzZeVYhkdv-q2Xml_KpA-a-_FIrnrqyuOzSa7j2hBagTNmpgN8pVTHvs3bCRK0Ots1XMCSvDzXTzgWD-umCUHTB6vtJ_2THI5UN-sUWfn46OEX7oXbXyKu1uWW2OtNrPotFlog77Say_Oe0CmEFxBMIi7-cdr2mREq5a5veF-UJ9UK1zMZCYAuYYsj8DW2-WT53P1JD_EICooFzDdMiMTKg Download .mp4 (1.9 MB) Help with .mp4 files Video 1Transesophageal echocardiogram demonstrating severe aortic and mitral valve stenosis. Video available at: http://www.jtcvsonline.org/article/S0022-5223(18)30037-0/fulltext.eyJraWQiOiI4ZjUxYWNhY2IzYjhiNjNlNzFlYmIzYWFmYTU5NmZmYyIsImFsZyI6IlJTMjU2In0.eyJzdWIiOiI2Zjg3ZDc1MzEzNzhjYTEyM2VjMjgwNjI1NTU3ZTY4NCIsImtpZCI6IjhmNTFhY2FjYjNiOGI2M2U3MWViYjNhYWZhNTk2ZmZjIiwiZXhwIjoxNjc4NTA5OTI1fQ.QW9kRxaWLMnnG33KRzWM4mSz0kLw-8F4mcgoI4BsthdH9P6y9w2Mn-G22r1vEJe1szD1q6pQOSOXuLT9aIvUOqnn_Inc-Wz_OTBFN7IkMjpEpcs7br7-TUNXn36D0uM8byCCZzPUniqKmGhKz3q_JKUMx62fYGPNxclmQ63xV3moHjTnQ3QS63AO5lf3Locd39Z1IApHQFZYdWNSr8gEx4BdI420Kc59IAQ3txA4aqW9YmrpVUtoFr-3kbpRcopId9UFxCk-Quna2-cI35HvavGIrUoU_W1dpa3OZXRaEJzdmHbJjrzjf9jxsT4nqI06PahwhAFWphrqpPjtWDocLw Download .mp4 (7.93 MB) Help with .mp4 files Video 2Fluoroscopic imaging showing deployment of a SAPIEN XT (Edwards Lifesciences, Irvine, Calif) 23-mm transcatheter heart valve within a 21-mm Mitroflow (Sorin Group Inc, Milan, Italy) surgical bioprosthesis in the aortic position. Video available at: http://www.jtcvsonline.org/article/S0022-5223(18)30037-0/fulltext.eyJraWQiOiI4ZjUxYWNhY2IzYjhiNjNlNzFlYmIzYWFmYTU5NmZmYyIsImFsZyI6IlJTMjU2In0.eyJzdWIiOiI5Mjg4ZTNmYmM2ZmI4ZjZhZjA5NjUzMWJiOTliMWZkYiIsImtpZCI6IjhmNTFhY2FjYjNiOGI2M2U3MWViYjNhYWZhNTk2ZmZjIiwiZXhwIjoxNjc4NTA5OTI1fQ.G_DLQ5TrasXFxvAmnFE_dpzv9N0uSs0zJOce1tyL0fKUFunOdL4zcv1d53UJvwr0pf2ZmiHDv4Mr_FWb1hkPFEE4ShIkPz6XX_iliXbLyVkrk6jMAVXEI9ANwimkf-0TCWJft_8ja4z1RXfRFzk2ZyrCu0AGLnjslnTJqHOfQWwHqskL96G_BWmR-aiH05BzKEebaOAZG5oHqq3T6RCsl8SdI6CvF4WAv49FWlDVpmGVgZVs5YlzJsVqqstiZUAfJNWHFMrA-TmQ9mzZu5Pxy7UazCRSxKfJzUYzhX7YPamhjnEYGlaH6FyTViPKnU5riI9g3Cmv8pAxfVGWQcrjJQ Download .mp4 (5.94 MB) Help with .mp4 files Video 3Fluoroscopic imaging showing deployment of a SAPIEN XT (Edwards Lifesciences, Irvine, Calif) 29-mm valve transcatheter heart valve within the calcified native mitral valve. Video available at: http://www.jtcvsonline.org/article/S0022-5223(18)30037-0/fulltext.eyJraWQiOiI4ZjUxYWNhY2IzYjhiNjNlNzFlYmIzYWFmYTU5NmZmYyIsImFsZyI6IlJTMjU2In0.eyJzdWIiOiIyODVkZjRkNjQ4MmMwODZiOTNjMzQ2OGQzYjNmOTZlYSIsImtpZCI6IjhmNTFhY2FjYjNiOGI2M2U3MWViYjNhYWZhNTk2ZmZjIiwiZXhwIjoxNjc4NTA5OTI1fQ.F384NrTAuE38YsbJlAXolmFoc9oSomJ8UjvzG_E8ND-fE0YGEOwHSI7KJmHMDwAfBdKJkK1oap6gjBdxnJOMkoUfbkElDux9Nb01bgeem3MrL3gLMBXHvm54ImWVIdGyoWDPTcizO8boEaNpwrlCQ2LcF0TeWqZdR0pUn0ObSV3djb4cYSj_R-N8UfNKukw5HSW1g3n5BtQdGleij9OWKjTvt_5SzO3jzoFa9i2XLZtxKkc48tqt6JtmCPWuHDN3mPlGhSTHiR42Ax4j06BNrTmohP3JdplPnVrcx3UfzssOfL0QUfHKpKQciKQJIMCP0wiSvOBeZ1uq98UtKwMPXQ Download .mp4 (1.58 MB) Help with .mp4 files Video 4Transesophageal echocardiogram demonstrating mild to moderate paravalvular leak after the procedure. Video available at: http://www.jtcvsonline.org/article/S0022-5223(18)30037-0/fulltext.eyJraWQiOiI4ZjUxYWNhY2IzYjhiNjNlNzFlYmIzYWFmYTU5NmZmYyIsImFsZyI6IlJTMjU2In0.eyJzdWIiOiIyMGUzOGM1YjlmYTFiYjY1YTBlOGU5MDM3Yjc0ZGE4NiIsImtpZCI6IjhmNTFhY2FjYjNiOGI2M2U3MWViYjNhYWZhNTk2ZmZjIiwiZXhwIjoxNjc4NTA5OTI1fQ.eEbtYBnBuybG2xz1eds6pzCiNZwSkNhlwe3AmGQ_qJZtpShrCgpj1gnFWJFs8L1iU7Ka29oFTakCk2qMofZPTebj0lb6qfttffkOFtwB7mhNBh3iugGqYZq5ZdiSJpWkodVgjfR5YUhjeW61TKuAuYaLvEqzrVho-6tCcF4K3UfHhSqrZEMEgZEoBMS3Gz2AEj2X_SyHypSvapXIg8WQct3zA_S5Hunu2JLXHgvlMa3yv9yawwdrWHJ9dCnjPU6rik7PPjEWBcQydvIUl5TVsErPtMuBa6qkdlLCF2AXVoRw85w9XULeDIYMgYJwcvh8oAYHvVF6R3LnnVBPmObEHw Download .mp4 (2.31 MB) Help with .mp4 files Video 5Transesophageal echocardiogram showing transcatheter mitral valve dysfunction. Video available at: http://www.jtcvsonline.org/article/S0022-5223(18)30037-0/fulltext.eyJraWQiOiI4ZjUxYWNhY2IzYjhiNjNlNzFlYmIzYWFmYTU5NmZmYyIsImFsZyI6IlJTMjU2In0.eyJzdWIiOiI0YTE3NzhhMzA4ZmM4ZTkyYzllOTEyOWU3NmYxZGU3YSIsImtpZCI6IjhmNTFhY2FjYjNiOGI2M2U3MWViYjNhYWZhNTk2ZmZjIiwiZXhwIjoxNjc4NTA5OTI1fQ.f4CI8OqDPt3c84zmnXtDvXcLNQduujbVMeIsZNMmKi9F3KYY4mQi3YSQMwYTtfRNUCI2rxIVPwEV2t8kNK-y8F0injfbo14gWa4pf24D1U6a9_Qt-8JJDXWLE-E8udyJMASNSy4iLY70doBIgzFWpg59OcjCW7U-T2jEGMtEuoJbiqt3gx-k6cLJ_XHZ_8BVP8-RZ2aJ7DmclGPyG92FU6ftLFKD0UqiofdE1kKLGOj9RQohh74GmrGUw8mRrYhd-Q9ZGRXXj8MSYtJxRvE4XW5eWeT3f1kLZ4319S4PS9uVkejJocH56Q3QYKViE7_EKLcYmSq_tmDy3d7aLEZWGg Download .mp4 (0.96 MB) Help with .mp4 files Video 6Transesophageal echocardiogram with color Doppler showing severe central mitral regurgitation. Video available at: http://www.jtcvsonline.org/article/S0022-5223(18)30037-0/fulltext.eyJraWQiOiI4ZjUxYWNhY2IzYjhiNjNlNzFlYmIzYWFmYTU5NmZmYyIsImFsZyI6IlJTMjU2In0.eyJzdWIiOiIyMWQ5OWZhNGZjMGE1NTIxYjhiOTAzNjYwMjIwNzkwMiIsImtpZCI6IjhmNTFhY2FjYjNiOGI2M2U3MWViYjNhYWZhNTk2ZmZjIiwiZXhwIjoxNjc4NTA5OTI1fQ.T6pTnhgBdaPnfsruOJOAuKWhxREtgAqFccQyg64KULgd4_UGFjmDPf1ZsCARDL6f-ogwl8RR4gz92ioFdTvfZz1lBCO4SITo9pXq7NPAue9f1r7vgB7OGKdC4BbbvQNRl58b1QViTvfNcvRGB-wjNxg9cQRvc7j6nJtbV9aXtDQ39dy6alQSY4uOCwPPDWbx2H9TSn1aDN1haNDld3_kHr8Jg1o1xu3bvZAsIYl7zB8ELqL9v8J_ofBSevjBDdp52xovyku3yHYYMlGIhHctcIE277irIs4EU349eQJ5JNgJppIGzPj8rLRo7Y6U6aiMwxSu4bbYQFUNjNqKMtFMQg Download .mp4 (4.95 MB) Help with .mp4 files Video 7Transesophageal echocardiogram demonstrating a native overhanging mitral valve leaflet. Video available at: http://www.jtcvsonline.org/article/S0022-5223(18)30037-0/fulltext.eyJraWQiOiI4ZjUxYWNhY2IzYjhiNjNlNzFlYmIzYWFmYTU5NmZmYyIsImFsZyI6IlJTMjU2In0.eyJzdWIiOiIwZjMyYTYyYTM2MjlmZmI5Y2M2ODNkM2YxZjQzNDhlMCIsImtpZCI6IjhmNTFhY2FjYjNiOGI2M2U3MWViYjNhYWZhNTk2ZmZjIiwiZXhwIjoxNjc4NTA5OTI1fQ.QlcIbB5ET-UAzlk53bznQIhUujXswIPziy1AtUN6NFukj7IpKXimYo5pO4YKIEVQBkaHr2BRfTP0A56pR8-PCjBNTy_t9wK0LMagU3zG_JptAwV4uUWZKPiBE38klrSa0ooX2hn3jwBZyXQQvLpH2dMJNlKhPTLOwSGGurpH2nYc_Hxrnpb7oOFgg-wX9T3rJ0-K2zjJA4tmigeKautyl_4fyr-ruLk1evadUYqMEFn3gAhfZBXTFSvRkCooqvkdistw6AgtWHN5QQMFc0sUI0JSxdAvUex3vS3jDtFg73e6JGnIJTVK8_toBbP2UNE6rh4S20khJ5sk_DTFcKtv9g Download .mp4 (6.73 MB) Help with .mp4 files Video 8Fluoroscopic imaging showing deployment of a SAPIEN XT (Edwards Lifesciences, Irvine, Calif) 29-mm valve in a more ventricular position. Video available at: http://www.jtcvsonline.org/article/S0022-5223(18)30037-0/fulltext.eyJraWQiOiI4ZjUxYWNhY2IzYjhiNjNlNzFlYmIzYWFmYTU5NmZmYyIsImFsZyI6IlJTMjU2In0.eyJzdWIiOiI0NjY5NDljZjIxZmZkYjY5M2RiNzhjMTVhMjNhM2FiZCIsImtpZCI6IjhmNTFhY2FjYjNiOGI2M2U3MWViYjNhYWZhNTk2ZmZjIiwiZXhwIjoxNjc4NTA5OTI1fQ.NStBai3U4jcjiKOaRdtnHRnFQ2TZ6aaw5WAXWFhVP4WK8gr3y4f2zC3KRgi7cYzrv6rnkxO1a-c01E3pk5jZpqxHPlrkaybTgg2Ay2N-3XMZnLLb-ZrzAU6u1iO4h4koQP0i_LwyZ7odhyBw6DRNydhmrEJdX7e6tI7sbcVEZdjmry6NFVubtwkvN1VLq7O5qpmDvIIvlM-jzGEERINjc8ILRXLbFUjL9Piygykdg5kOfAKZUxikW90oPgx7QZvcZVFjrXo0xjTA4NAs2xxcAw5NlGZuffx7-gWKSSWiNcgTB3bQssH5yx4cdZmslvaWh5Xn2HolDgG14nPtoK5ZPQ Download .mp4 (1.24 MB) Help with .mp4 files Video 9Transesophageal echocardiogram with color Doppler showing minimal mitral regurgitation after the mitral valve-in-valve procedure. Video available at: http://www.jtcvsonline.org/article/S0022-5223(18)30037-0/fulltext. Transcatheter mitral valve replacement in patients with severe mitral annular calcification: Pushing the limits to the skyThe Journal of Thoracic and Cardiovascular SurgeryVol. 155Issue 6PreviewIn this issue of the Journal, Poulin and colleagues1 report a very interesting and potentially fatal complication of subacute mitral valve dysfunction after transcatheter aortic valve replacement and transcatheter mitral valve replacement (TMVR) in a high-risk patient with previous surgical aortic valve replacement. Preprocedural imaging showed a failing aortic valve bioprosthesis (21-mm Mitroflow; LivaNova PLC, London, United Kingdom) with relevant stenosis and regurgitation, combined with a degenerative mitral valve disease and severe mitral annular calcification (MAC; mean pressure gradient of 8 mm Hg, valve area of 0.96 cm2). Full-Text PDF Open Archive
BACKGROUND Very few reports of long-term outcomes of patients who underwent the Ross procedure have been published.OBJECTIVES The authors reviewed their 25-year experience with the Ross procedure with the aim of defining very-long-term survival and factors associated with Ross-related failure.METHODS Between January 1990 and December 2014, the Ross procedure was performed in 310 adults (mean age 40.8 years) at a single institution. All patients were prospectively added to a dedicated cardiac surgery registry. Complete post-operative clinical examination and history were obtained, and transthoracic echocardiography was performed according to a standardized protocol. There was no loss to follow-up. Median follow-up was 15.1 years and up to 25 years.RESULTS Bicuspid aortic valve was diagnosed in 227 patients (73.2%), and the most common indication for surgery was aortic stenosis (n = 225 [72.6%]). Freedom from any Ross-related reintervention was 92.9% and 70.1% at 10 and 20 years, respectively. Independent risk factors for pulmonary autograft degeneration were pre-operative large aortic annulus (hazard ratio: 1.1; p = 0.01), pre-operative aortic insufficiency (hazard ratio: 2.7; p = 0.002), and concomitant replacement of the ascending aorta (hazard ratio: 7.7; p = 0.0003). There were 4 hospital deaths (1.3%), and overall survival at 10 and 20 years was 94.1% and 83.6%, respectively. Long-term survival was not significantly different in patients who required Ross-related reintervention (log-rank p = 0.70). However, compared with the general population, survival was significantly lower in patients following the Ross procedure when matched on age and sex (p < 0.0001).CONCLUSIONS The Ross procedure was associated with excellent long-term valvular outcomes and survival, regardless of the need for reintervention. Adults presenting with aortic insufficiency or a dilated aortic annulus or ascending aorta were at greater risk for reintervention. Unlike previous reports, long-term survival was lower in Ross patients compared with matched subjects. (C) 2017 by the American College of Cardiology Foundation.
Background: At present, there are no objective data specifically examining the clinical impact of variations in exercise capacity post–transcatheter aortic valve replacement (TAVR). We describe the changes in exercise capacity between baseline and 6 months post-TAVR, and ascertain factors associated with and clinical implications of a lack of improvement in exercise capacity post-TAVR. Methods: A total of 305 patients (mean age, 79±9 years; 44% men; Society of Thoracic Surgeons predicted risk mortality score, 6.7±4.2%) undergoing TAVR completed both baseline and follow-up exercise capacity assessments at 6 months post-TAVR. Exercise capacity was evaluated by the 6-minute walk test (6MWT). Clinical outcomes were compared between patients displaying greater than (n=152; improving group) versus less than (n=153; nonimproving group) the median percentage change in distance walked between baseline and 6-month follow-up examinations. The primary outcome measure was clinical event rates, measured from the 6-month post-TAVR period onward. Further dichotomization according to baseline 6MWT distance (less than versus more than median walking distance, or slow walker versus fast walker) was also assessed. Results: The mean overall distances walked pre- and post-TAVR (6 months post-TAVR) were 204±119 and 263±116 m, respectively (&Dgr;6MWT=60±106 m), with 219 (72%) patients demonstrating an increase in their walking distance (median percentage increase of the entire population was 20% [interquartile range, 0%–80%]). Factors independently correlated with reduced exercise capacity improvement included a range of baseline clinical characteristics (older age, female sex, chronic obstructive pulmonary disease; P<0.05 for all), periprocedural major or life-threatening bleeding (P=0.009) and new-onset anemia at 6 months post-TAVR (P=0.009). Failure to improve the 6MWT distance by at least 20% was independently associated with all-cause mortality (P=0.002) and cardiovascular death or rehospitalization for cardiovascular causes (P=0.001). Baseline slow walkers who were able to improve the 6MWT distance presented with significantly better outcomes than nonimprovers (P=0.01 for all-cause mortality; P=0.001 for cardiovascular end point). Conclusions: Approximately one-third of patients undergoing TAVR did not improve their exercise capacity postprocedure. The lack of functional improvement post-TAVR was predicted by a mix of baseline and periprocedural factors translating into poorer clinical outcomes. These results suggest that systematically implementing exercise capacity assessment pre- and post-TAVR may help to improve patient risk stratification.
Transcatheter aortic valve in valve implantation (ViV) has emerged as a valuable technique to treat failing bioprostheses (BP) in high-risk patients. However, the hemodynamic results following ViV are not often optimal with the persistence of high residual gradients (HG) and prosthesis-patient mismatch (PPM). BP size (≤ 21 mm) and degeneration of BP by stenosis have been related to the presence of worse outcomes post-ViV. However, no distinction was made between acquired stenosis (i.e. BP structural degeneration) vs. pre-existent PPM of the surgical BP. The objective of this study was to determine the correlates for bad hemodynamic outcomes post-ViV. Early post-surgical aortic valve replacement (SAVR), pre-VinV, and post-VinV echocardiographic data of 50 consecutive patients who underwent aortic ViV at our institution were retrospectively analyzed. The primary endpoint was a composite of the occurrence of high gradient (HG: ≥ 20 mmHg) and severe PPM (sPPM: indexed effective orifice area by BSA [EOAi] < 0.65 cm2/m2). Mean transvalvular gradient after ViV was 23.5 ±11.0 mmHg and EOAi was 0.58 ±0.18 cm2/m2. HG and/or sPPM after ViV procedure were observed in 70% of the patients. Patients with pre-existent sPPM (i.e. sPPM after initial SAVR) had much higher rate of HG and/or sPPM (100% vs. 57.1%; p=0.002) compared to patients without pre-existent sPPM. In univariate analysis, the composite endpoint was correlated with BP type (p=0.002), BP internal orifice diameter (p=0.01) and pre-existent sPPM (p=0.002) and there was a strong trend toward correlation with BP mode of failure (p=0.07). After adjustment for BP true internal diameter, mode of failure (stenosis vs regurgitation), and BP type, the presence of pre-existent sPPM was associated with increased risk of high gradients and/or sPPM post-ViV (p=0.03). In this series of patients who underwent aortic ViV, pre-existent severe PPM was strongly and independently associated with worse hemodynamic outcomes. ViV can indeed improve the hemodynamic outcomes in the context of acquired stenosis or regurgitation of the BP but not in the context of pre-existent severe PPM. These findings provide strong support for the prevention of severe PPM at the time of SAVR and for the systematic integration of the assessment of pre-existent PPM in the risk stratification and decision making processes prior to-VinV.
AIMS:The aim of this study was to evaluate, in anaemic patients, the efficacy of erythropoietin (EPO) in reducing red cell (RC) transfusion rates post TAVI.METHODS AND RESULTS:This was a randomised double-blind trial. Patients with severe symptomatic aortic stenosis and concomitant anaemia with an indication for TAVI were randomised (1:1) to receive two weight-based doses of EPO (darbepoetin alfa)+iron or placebo at days 10 (±4 days) and 1 (±1 day) pre TAVI. The primary outcome was the rate of RC transfusions at 30 days. A total of 100 patients (mean age 81±7 years, male 49%) were included: 48 patients received EPO (+iron) and 52 patients received placebo. Baseline characteristics and procedural findings were well balanced between groups except for baseline haemoglobin levels, which were lower in those patients receiving EPO (10.7±1.2 vs. 11.3±1.1 g/dl, p=0.01). The rate of 30-day RC transfusion was similar in both groups (27.1 vs. 25.0% in the EPO and placebo groups, respectively; adjusted odds ratio 1.05, 95% CI: 0.42-2.64, p=0.92), and no differences were observed in the number of RC units per transfused patient (1 [1-3] vs. 2 [1-2] in the EPO and placebo groups, respectively, adjusted p=0.99). Rates of 30-day mortality, stroke, new-onset atrial fibrillation, acute kidney injury, and troponin peak were also similar between groups (p>0.20 for all).CONCLUSIONS:EPO (+iron) administration failed to reduce RC transfusion rates or the per-patient number of transfusion units in anaemic patients undergoing TAVI.
Transapical or transaortic approaches are the most commonly used alternative approaches for transcatheter aortic valve replacement (TAVR). However, the common carotid artery (CCA) may provide a feasible vascular access with the advantage of avoiding thoracotomy. Herein, we examine the early outcomes associated with this relatively novel approach to TAVR. Since May 2015, 39 patients with a mean age of 78 ± 7.4 years underwent transcarotid (TC)-TAVR in our center. A combination of imaging and functional testing is done to evaluate the suitability of the transcarotid approach: assessment of CCA size (≥7 mm), patency, and absence of calcification by CT- angiography, as well as echo Doppler interrogation to rule-out significant flow distortion and stenosis of both proximal common and internal carotid arteries. All interventions were performed under general anesthesia and surgical cutdown. The adequacy of cerebral perfusion was indeirectly assessed using two different. 1-Backflow arterial pressure measurement after proximal CCA clamping; 2- cerebral oximetry monitoring during proximal CCA occlusion. A drop of the backflow pressure to less than 30 mmHg and/or 50% baseline cerebral saturation during the clamp test constituted our triggers to perform a temporary femoro-distal CCA external shunt. TAVR was then performed using balloon- (n=17) or self-expandable (n=21) valves. Early outcomes and follow-up data were assessed. No patient required temporary external CCA shunting. Procedural success was 97.4%. One patient converted to transapical approach due to difficulty inserting the introducer sheath. Mean procedure time was 74 ± 15.5 minutes. Two patients had access-site complications repaired with a focal prosthetic patch. There was one fatal post-operative hemorrhagic stroke on day 6. There was no symptomatic embolic stroke/transient ischemic attack, or de novo atrial fibrillation within 30 post-operative days. The mean intubation period was 1.3 hours. Nineteen patients were extubated in the operating room. Blood product transfusion was required in 3 patients during hospitalization. Mean hospital stay was 4.8 ± 2.5 days, and 12 patients were discharged three days after the intervention. Mean follow-up was 6 months and was complete in all patients. There were no deaths or cerebrovascular event in the mid-term. As an alternative approach, transcarotid TAVR is a feasible and safe technique in selected patients with very promising early and mid-term clinical outcomes. The combination of preoperative imaging and intraoperative functional testing of the cerebral circulation is a simple and effective measure that establishes the safety of this procedure.
Background The influence of coronary artery disease (CAD) on clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR) is still controversial. We sought to evaluate the impact of CAD severity as measured by the SYNTAX score (SS) on patients undergoing TAVR. Methods and Results A total of 377 patients who underwent TAVR in 2 high‐volume centers in North America were included in our retrospective analysis. A blinded angiographic core laboratory calculated the SS on all available coronary angiograms with the use of quantitative coronary analysis. Patients were stratified into 4 groups: (1) no CAD (SS=0); (2) low SS (SS between 1 and 22); (3) intermediate SS (SS between 23 and 32); and (4) high SS (SS ≥33). Patients who had undergone percutaneous coronary intervention within 6 months prior to TAVR were separated into 2 categories based on their residual SS (<8 and ≥8). Patients with previous coronary artery bypass grafting (CABG) were divided into 2 groups: (1) low CABG SS and (2) high CABG SS. The primary end point was a composite of all‐cause mortality, myocardial infarction, and stroke. At 30 days and 1 year, both the presence and the severity of CAD had no impact on the rate of the combined primary end point and on all‐cause mortality, cardiovascular mortality, and myocardial infarction. Patients with less complete revascularization (residual SS ≥8 versus residual SS <8 and low CABG SS versus high CABG SS, had similar rates of the combined primary end point, all‐cause mortality, cardiovascular mortality, MI, and stroke, at both 30 days and 1 year. Conclusions In our core laboratory–validated study, neither the severity of CAD nor completeness of revascularization after percutaneous coronary intervention or CABG were associated with clinical outcomes after TAVR, at both 30 days and 1 year.
Respiratory complications are a major factor contributing to postoperative morbidity and mortality, especially in patients with chronic obstructive pulmonary disease (COPD). Our objective was to compare the rate of respiratory complications in patients with COPD with severe aortic stenosis who underwent transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR). Low-to-intermediate surgical-risk patients with moderate or severe COPD who underwent TAVI or SAVR at 2 tertiary centers were included in this study. COPD was defined by the Global Initiative for Chronic Lung Disease classification. The primary end point was the 30-day composite of respiratory mortality, prolonged ventilation (>24 hours), the need for reintubation for respiratory causes, tracheostomy, acute respiratory distress syndrome, pneumonia, or pneumothorax. The inverse probability of treatment weighting was determined to reduce baseline imbalance between the 2 groups. A total of 321 patients (mean age 72.4 +/- 9.3 years old, 74.5% male, mean Society of Thoracic Surgeons predicted risk of mortality 3.8 +/- 1.9%, mean forced expiratory volume 1: 59 +/- 13%) were included in the analysis. TAVI was performed in 122 patients, whereas 199 underwent SAVR. There were no differences between the 2 groups regarding the composite respiratory primary end point (SAVR 10.6%, TAVR 7.4%, adjusted odds ratio 0.57, 95% confidence interval 0.20 to 1.65, p = 0.30). Transfemoral TAVI without general anesthesia (28 patients) was associated with the lowest rate of respiratory complications (3.6%). Among patients with moderate or severe COPD at low-to-intermediate surgical risk, TAVI patients had a similar rate of 30-day major pulmonary complications compared with SAVR patients despite a higher baseline risk profile. Future studies should further investigate whether TAVI is associated with reduced respiratory complications, comparing transfemoral TAVI recipients treated with local anesthesia with their SAVR counterparts. (C) 2017 Elsevier Inc. All rights reserved.
BACKGROUND Data regarding the mid-to tong-term cognitive trajectory of transcatheter aortic valve (TAVR) recipients are scarce.OBJECTIVES Changes in global cognition and specific cognitive domains up to 1 year post-TAVR were evaluated.METHODS Fifty-one patients (median age 80.0 [interquartile range: 72.0 to 85.0] years; 37% women) underwent TAVR and prospective assessment of cognitive function using the Montreal Cognitive Assessment (MoCA) at baseline, short-term (30 days), and 1 year post-TAVR. Processing speed and executive cognitive functions were further evaluated with the digit-symbol substitution test (DSST), Trail Making Tests (TMT), and verbal fluency tests at the same time points. Cognitive decline (CD) was determined by changes in mean scores and as a rate using practice-corrected reliable change index (RCI).RESULTS The baseline mean total MoCA score was 22.71 +/- 3.84. Twenty patients (39.2%) were considered cognitively impaired using a cutoff of <23 of 30 points. Mean total MoCA score improved at short-term post-TAVR and remained stable at 1 year (p = 0.022). On the basis of the RCI of total MoCA score, 4 patients (7.8%) presented with short-term CD, which persisted at 1 year in 1 patient (2.0%). Four patients (7.8%) exhibited cognitive improvement at 1 year, increasing to 15% among those with baseline cognitive impairment. No significant changes were observed over time in the mean DSST, TMT, and verbal fluency test scores. On the basis of the RCI, 10 of 40 patients (25%) presented with a reduction in performance of at least 1 test at 30 days that persisted at 1 year in 4 patients (10%).CONCLUSIONS TAVR was associated with global improvement in cognitive status, more pronounced among those with cognitive impairment pre-TAVR. However, early decline in some complex cognitive functions was observed in one-quarter of TAVR recipients, persisting at 1 year in 10% of patients. (C) 2016 by the American College of Cardiology Foundation.
BACKGROUND:Stroke remains one of the most worrisome complications following transcatheter aortic valve replacement (TAVR). This pilot study evaluates the safety, feasibility, and exploratory efficacy of the TriGuard HDH embolic deflection device (Keystone Heart Ltd., Caesarea, Israel) in patients undergoing transaortic TAVR.METHODS:A total of 10 patients (median age: 81 years, STS score: 9.6 ± 5.6%) undergoing transaortic TAVR were included. All 30-day events were recorded and defined according to Valve Academic Research Consortium-2 criteria. Cerebral diffusion-weighted magnetic resonance imaging exams were planned preprocedure and within 10 days post-TAVR. The results of the magnetic resonances were analyzed in an independent core laboratory blinded to clinical data. Neurocognitive evaluation tests (Montreal Cognitive Assessment, Cogstate, Digit Symbol Substitution Test, Word Fluency Test, and Trailmaking tests) were performed at baseline, and within 10 and 30 days post-TAVR.RESULTS:The TriGuard HDH device was successfully deployed in all patients without complications. There was one procedural major vascular complication unrelated to the study device, and no clinically apparent stroke events were observed at 30-day follow-up. Cerebral diffusion weighted magnetic resonance imaging exams were performed in six patients at 7.5 ± 1.9 days post-TAVR showing the presence of new ischemic lesions in five patients (83.3%), which were single lesions in 60% of these individuals. Paired neurocognitive evaluation tests demonstrated no significant changes in neurocognitive parameters over time.CONCLUSIONS:This study shows the safety and feasibility of using the TriGuard HDH embolic protection device in transaortic TAVR. Further studies are warranted to determine the efficacy of embolic protection in this population.