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1.

Objectives

The aim of this study was to compare self-expanding and balloon-expandable transcatheter heart valves (THVs) in large versus small aortic valve annuli.

Background

The degree of THV oversizing varies according to annular size, and this can modify the hemodynamic performance of self-expanding and balloon-expandable THVs.

Methods

Patients undergoing transcatheter aortic valve replacement in the randomized CHOICE (Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve vs Edwards SAPIEN XT) trial (CoreValve [CV], n = 120; SAPIEN XT [SXT], n = 121) and the nonrandomized CHOICE-Extend registry (Evolut R [ER], n = 100; SAPIEN 3 [S3], n = 334) were compared for THV performance by echocardiography (in all patients) and by cardiac magnetic resonance imaging (MRI) regurgitant fraction (RF) (in a subgroup of patients). Patients were stratified according to aortic valve annular mean diameter into those with large (>23 mm) or small (≤23 mm) annuli.

Results

THV percentage oversizing was 19.1 ± 6.4% with the CV, 11.4 ± 7.0% with the SXT, 18.8 ± 4.8% with the ER, and 3.7 ± 5.5% with the S3. Transvalvular mean pressure gradient was lower with the CV and ER than with the SXT and S3 in both the large and small annulus groups. In the randomized CHOICE trial, moderate to severe prosthetic valve regurgitation (PVR) was more with the CV than the SXT in large annuli (15.1% vs. 0.0%; p = 0.002; MRI RF: 10.5 ± 10.2% vs. 4.4 ± 4.5%; p = 0.036) but not in small annuli (0.0% vs. 5.7%; p = 0.50; MRI RF: 4.0 ± 4.1% vs. 4.0 ± 3.4%; p = 0.98). In the CHOICE-Extend registry, moderate to severe PVR occurred in 2 patients, and any PVR was not significantly different between the ER and the S3 in large (41.7% vs. 32.5%; p = 0.24) or small (47.1% vs. 43.8%; p = 0.84) annuli. MRI RF was not different in large annuli (5.0 ± 3.8% vs. 5.0 ± 6.1%; p = 0.99) but was significantly lower with the ER than the S3 in small annuli (2.9 ± 2.3% vs. 4.8 ± 3.7%; p = 0.023). On multivariate analysis, transcatheter aortic valve replacement with the ER in small annuli was associated with a lower rate of prosthesis-patient mismatch than with the S3, with no increased risk for PVR.

Conclusions

Older-generation balloon-expandable THVs were associated with less PVR than self-expanding THVs in patients with large but not small annuli. The next-generation self-expanding THV has improved sealing in patients with large annuli and may have potential advantages in patients with small annuli.  相似文献   

2.

Objectives

The aims of this study were to report on the use of local anesthesia or conscious sedation (LACS) and general anesthesia in transcatheter aortic valve replacement and to analyze the impact on outcome.

Background

Transcatheter aortic valve replacement can be performed in LACS or general anesthesia. Potential benefits of LACS, such as faster procedures and shorter hospital stays, need to be balanced with safety.

Methods

A total of 16,543 patients from the German Aortic Valve Registry from 2011 to 2014 were analyzed, and propensity-matched analyses were performed to correct for potential selection bias.

Results

LACS was used in 49% of patients (8,121 of 16,543). In hospital, LACS was associated with lower rates of low-output syndrome, respiratory failure, delirium, cardiopulmonary resuscitation, and death. There was no difference in paravalvular leakage (II+) between LACS and general anesthesia in the entire population (5% vs. 4.8%; p = 0.76) or in the matched population (3.9% vs. 4.9%, p = 0.13). The risk for prolonged intensive care unit stay (≥3 days) was significantly reduced with LACS (odds ratio: 0.82; 95% confidence interval [CI]: 0.73 to 0.92; p = 0.001). Thirty-day mortality was lower with LACS in the entire population (3.5% vs. 4.9%; hazard ratio [HR]: 0.72; 95% CI: 0.60 to 0.86; p < 0.001) and in the matched population (2.8% vs. 4.6%; HR: 0.6; 95% CI: 0.45 to 0.8; p < 0.001). However, no differences in 1-year mortality between both groups in the entire population (16.5% vs. 16.9%; HR: 0.93; 95% CI: 0.85 to 1.02; p = 0.140) and in the propensity-matched population (14.1% vs. 15.5%; HR: 0.90; 95% CI: 0.78 to 1.03; p = 0.130) were observed.

Conclusions

Use of LACS in transcatheter aortic valve replacement is safe, with fewer post-procedural complications and lower early mortality, suggesting its broad application.  相似文献   

3.

Objectives

The present study aimed to test the clinical benefit of combined transcatheter mitral plus tricuspid valve edge-to-edge repair (TMTVR) as compared with transcatheter mitral valve edge-to-edge repair (TMVR) alone in patients with both significant mitral (MR) and tricuspid regurgitation (TR) at high surgical risk.

Background

A growing number of patients with severe MR at increased surgical risk are treated by transcatheter techniques. Evidence suggests that residual TR remains a predictor of adverse outcome in these patients.

Methods

Sixty-one patients (mean age 79.5 ± 8.4 years, EuroSCORE II 8.6 ± 5.9%) underwent TMTVR (n = 27) or TMVR (n = 34). Echocardiographic and cardiac magnetic resonance imaging was performed before and after the procedure.

Results

Reduction of MR was similar in patients undergoing TMTVR and TMVR. Effective regurgitant orifice area of TR was reduced from 0.51 to 0.29 cm2 in patients with TMTVR (p < 0.01), but remained unchanged after TMVR. On cardiac magnetic resonance imaging, only patients in the TMTVR group exhibited improved effective right and left ventricular stroke volume, and increased cardiac index (2.1 vs. 2.5 l/min/m2; p < 0.01). TMTVR led to superior improvement in New York Heart Association functional class, NT-proBNP levels, and 6-min walking distance as compared with TMVR. After up to 18 months of follow-up, patients with TMTVR experienced fewer hospitalizations for heart failure when compared with patients with TMVR (p = 0.02), whereas rates of death were comparable between both groups of patients.

Conclusions

TMTVR appears superior to TMVR in terms of cardiac output and functional improvement early after the intervention, and improves clinical outcome up to 18 months of follow-up.  相似文献   

4.
ObjectivesTo perform a meta-analysis including all available randomized controlled trials (RCTs) to date comparing transcatheter aortic valve replacement (TAVR) to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) and low surgical risk.BackgroundCurrent guidelines recommend SAVR for patients with severe symptomatic AS and low surgical risk. A few RCTs have evaluated TAVR in low surgical risk patients but equipoise exists related to TAVR valve durability, paravalvular leak (PVL) and role of TAVR in younger, low surgical risk patients.MethodsFive databases were analyzed from January-2000 to March-2019 for RCTs comparing SAVR to TAVR in low-risk severe AS patients.ResultsFour RCTs on low-risk TAVR patients with 2887 patients were included. Mean follow-up was ~24.1 ± 24 months. Early mortality was lower with TAVR compared to SAVR (RR: 0.44, 95% CI: 0.20–0.95, P = 0.038) whereas long-term mortality was similar (RR: 0.67, 95% CI: 0.39–1.14, P = 0.141). Both early and long-term stroke rates were similar. TAVR was associated with lower risk of atrial fibrillation, major bleeding, acute kidney injury (AKI) and rehospitalization, but higher rates of permanent pacemaker implantation (PPM) and moderate or severe PVL. There was no difference in major vascular complications, myocardial infarction, endocarditis, aortic valve gradients and valve area at follow-up.ConclusionsIn low-risk patients with severe AS, TAVR has a lower early mortality compared to SAVR with no difference in long-term mortality. Although complication rates varied between TAVR and SAVR, our study findings suggest that transfemoral-TAVR is an appropriate treatment option for severe symptomatic AS in patients with low surgical risk.  相似文献   

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6.

Purpose of Review

This review aims to summarize data regarding bioprosthetic valve fracture (BVF), a novel technique that involves fracturing the surgical valve sewing ring to allow for further expansion of the transcatheter heart valve in patients undergoing valve in valve transcatheter aortic valve replacement (VIV TAVR).

Recent Findings

Bench testing and clinical experience have demonstrated that most, but not all, bioprosthetic surgical valves can be fractured. BVF in patients with small- and intermediate-sized surgical valves results in a lower residual valve gradient and larger final valve effective orifice area as compared with standard VIV TAVR. However, whether patients with larger bioprothetic valves benefit from BVF, and whether the hemodynamic benefits of BVF translate into improved clinical outcomes, is unknown.

Summary

BVF improves the hemodynamic results of VIV TAVR in small surgical valves. However, further research is needed to determine whether BVF is beneficial for patients with larger surgical valves, and whether the hemodynamic benefits of BVF result in improved clinical outcomes.
  相似文献   

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8.

Objectives

The aim of this study was to further evaluate clinical outcomes in patients with and without PCS.

Background

Prior cardiac surgery (PCS) is associated with increased surgical risk and post-operative complications following surgical aortic valve replacement (SAVR), but whether this risk is similar in transcatheter aortic valve replacement (TAVR) is unclear.

Methods

In the PARTNER 2A (Placement of Aortic Transcatheter Valve) trial, 2,032 patients with severe aortic stenosis at intermediate surgical risk were randomized to TAVR with the SAPIEN XT valve or SAVR. Adverse clinical outcomes at 30 days and 2 years were compared using Kaplan-Meier event rates and multivariate Cox proportional hazards regression models. The primary endpoint of the PARTNER 2 trial was all-cause death and disabling stroke.

Results

Five hundred nine patients (25.1%) had PCS, mostly (98.2%) coronary artery bypass grafting. There were no significant differences between TAVR and SAVR in patients with or without PCS in the rates of the primary endpoint at 30 days or 2 years. Nevertheless, an interaction was observed between PCS and treatment arm; whereas no-PCS patients treated with TAVR had higher rates of 30-day major vascular complications than patients treated with SAVR (adjusted hazard ratio: 2.66; 95% confidence interval: 1.68 to 4.22), the opposite was true for patients with PCS (adjusted hazard ratio: 0.27; 95% confidence interval: 0.11 to 0.66) (pinteraction <0.0001). A similar interaction was observed for life-threatening or disabling bleeding.

Conclusions

In the PARTNER 2A trial of intermediate-risk patients with severe aortic stenosis undergoing SAVR versus TAVR, the relative risk for 2-year adverse clinical outcomes was similar between TAVR and SAVR in patients with or without PCS.  相似文献   

9.

Background

There is little information concerning infective endocarditis (IE) in patients with bicuspid aortic valve (BAV) or mitral valve prolapse (MVP). Currently, IE antibiotic prophylaxis (IEAP) is not recommended for these conditions.

Objectives

This study sought to describe the clinical and microbiological features of IE in patients with BAV and MVP and compare them with those of IE patients with and without IEAP indication, to determine the potential benefit of IEAP in these conditions.

Methods

This analysis involved 3,208 consecutive IE patients prospectively included in the GAMES (Grupo de Apoyo al Manejo de la Endocarditis infecciosa en España) registry at 31 Spanish hospitals. Patients were classified as high-risk IE with IEAP indication (high-risk group; n = 1,226), low- and moderate-risk IE without IEAP indication (low/moderate-risk group; n = 1,839), and IE with BAV (n = 54) or MVP (n = 89).

Results

BAV and MVP patients had a higher incidence of viridans group streptococci IE than did high-risk group and low/moderate-risk group patients (35.2% and 39.3% vs. 12.1% and 15.0%, respectively; all p < 0.01). A similar pattern was seen for IE from suspected odontologic origin (14.8% and 18.0% vs. 5.8% and 6.0%; all p < 0.01). BAV and MVP patients had more intracardiac complications than did low/moderate-risk group (50% and 47.2% vs. 30.6%, both p < 0.01) patients and were similar to high-risk group patients.

Conclusions

IE in patients with BAV and MVP have higher rates of viridans group streptococci IE and IE from suspected odontologic origin than in other IE patients, with a clinical profile similar to that of high-risk IE patients. Our findings suggest that BAV and MVP should be classified as high-risk IE conditions and the case for IEAP should be reconsidered.  相似文献   

10.
11.
Mitral valve regurgitation frequently accompanies aortic valve stenosis. It has been suggested that mitral regurgitation improves after aortic valve replacement alone and that the mitral valve need not be replaced simultaneously Furthermore, mitral regurgitation associated with coronary artery disease, particularly in patients with poor left ventricular function, shows immediate improvement after coronary artery bypass grafting. We studied 60 consecutive patients with aortic stenosis and mitral regurgitation to determine the degree of improvement in mitral regurgitation after aortic valve replacement alone versus aortic valve replacement combined with coronary artery bypass grafting. Thirty-six of the patients had normal coronary arteries (Group 1); the other 24 had symptomatic coronary artery disease requiring bypass surgery (Group 2). Echocardiography was performed preoperatively, 1 week postoperatively, and at follow-up. In Group 1, left ventricular ejection fraction did not improve early or at 2.5 months postoperatively, but mitral regurgitation improved gradually during follow-up. In Group 2, mitral regurgitation showed improvement 1 week postoperatively (p < 0.001), and left ventricular ejection fraction was improved at 2.5 months. We conclude that patients with aortic valve stenosis and mild-to-severe mitral regurgitation, without echocardiographic signs of chordal or papillary muscle rupture and without coronary artery disease, should undergo aortic valve replacement alone. The mitral regurgitation will remain the same or improve. For patients with coexisting coronary artery disease, simultaneous aortic valve replacement and coronary artery bypass grafting are imperative; however, the mitral valve again requires no intervention, since mitral regurgitation improves significantly after the other 2 procedures.  相似文献   

12.
Although the results of the early TAVI experience are promising, longer-term follow-up is necessary before the procedure can be extended to lowerrisk patients. Many issues are not yet resolved, including the long-term effects of paravalvular leaks (which occur in most TAVI patients), the true stroke rate in TAVI patients (which is probably in the range of 5% to 6%), and the need for permanent pacemaker implantation (which ranges from 5% to 40% in TAVI patients, depending upon the device used). As the procedure is extended into the lower-risk population, these issues will assume greater import than they have in the population currently in treatment—very elderly, high-risk patients with limited life expectancy. As in the coronary-revascularization paradigm of percutaneous coronary intervention versus coronary artery bypass grafting, there will be increasing adoption of the transcatheter approach. Just as the rumors of the demise of surgical bypass were premature, conventional AVR will continue to be the predominant technique for the treatment of aortic stenosis during at least the next decade. Although the percentage of patients treated by a transcatheter approach will continue to increase, regulatory and reimbursement factors are likely to be the primary determinants of the rate of adoption.  相似文献   

13.
14.
15.

Objectives

The purpose of this study was to review the institutional practice of surveillance transthoracic echocardiography (TTE) for diagnosing early prosthetic valve dysfunction (PVD).

Background

Bioprosthetic valve thrombosis (BPVT) is an important cause of PVD, and guidelines do not recommend routine TTE during the first 5 years after valve implantation.

Methods

The authors performed a retrospective case-control study of all suspected (imaging diagnosis) or confirmed (histopathological diagnosis) cases of BPVT from January 1997 through December 2016. Patients were matched 1:2 (age, sex, prosthesis position) to patients whose prostheses were explanted because of structural failure (SF). PVD was defined as a 50% increase above baseline gradient at valve implantation and classified as early (≤5 years) or late (>5 years) after implantation.

Results

There were 94 BPVT (51 suspected, 43 confirmed) and 188 SF cases; patient age 61 ± 9 years; men 61 (65%). The prosthesis positions were aortic 56%; mitral 26%; tricuspid 15%; and pulmonary 3%. Early PVD was more common in the BPVT versus SF group: 83 of 94 (88%) versus 20 of 188 (11%) (p < 0.001). Time from implantation to PVD was shorter for BPVT than SF: 26 months (interquartile range [IQR]: 12 to 43 months) versus 74 months (IQR: 48 to 102 months) (p < 0.001). At the initial PVD diagnosis, 81% of BPVT and 90% of SF patients were asymptomatic. However, BPVT patients had rapid symptomatic deterioration, requiring intervention sooner after PVD diagnosis: 6 months (IQR: 4 to 7 months) versus 51 months (IQR: 22 to 55 months) (p < 0.001).

Conclusions

Most patients with PVD due to BPVT were asymptomatic at initial diagnosis, which was made based on routine surveillance TTE, often performed before 5 years. BPVT, an acute disease process, requires timely diagnosis because patient conditions rapidly deteriorate. Further studies are needed to determine whether routine surveillance TTE should be considered for patients with bioprosthetic valves to identify pre-symptomatic features of BPVT in order to provide effective, appropriate therapy.  相似文献   

16.
ObjectivesThe aim of this study was to compare outcomes after transcatheter aortic valve replacement (TAVR) in patients with pure aortic stenosis (AS) (i.e., no or trivial associated aortic regurgitation [AR]) with those in patients with AS and mild or more severe AR (i.e., mixed aortic valve disease [MAVD]).BackgroundTAVR is indicated in treating patients with severe AS. Limited data exist regarding the outcomes of TAVR in patients with MAVD.MethodsA total of 1,133 patients who underwent TAVR between January 2014 and December 2017 were included. The primary outcome was all-cause mortality. The comparison was adjusted to account for post-TAVR AR development in both groups. The secondary outcomes included composite endpoints of early safety and clinical efficacy as specified in the Valve Academic Research Consortium-2 criteria. Variables were compared using Mann-Whitney, chi-square, and Fisher exact tests, while Kaplan-Meier analyses were used to compare survival.ResultsA total of 688 patients (61%) had MAVD (median age 83 years , 43% women). Among these, 17% developed mild, 2% moderate, and <1% severe post-TAVR AR. Overall, patients with MAVD had better survival compared with patients with pure AS (p = 0.03). Among patients who developed post-TAVR AR, those in the MAVD group had better survival (p = 0.04). In contrast, in patients who did not develop post-TAVR AR, pre-TAVR AR did not improve survival (p = 0.11).ConclusionsPatients with MAVD who underwent TAVR had better survival compared with patients with pure AS. This is explained by the better survival of patients with MAVD who developed post-TAVR AR, likely due to left ventricular adaptation to AR.  相似文献   

17.

Objectives

The aim of this study was to assess the commissural alignment between bioprosthetic and native aortic valve leaflets following surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) and to investigate its impact on valvular function and coronary filling.

Background

Expansion and geometry have been shown to affect leaflets of implanted transcatheter aortic bioprosthesis, but commissural alignment has not been studied.

Methods

Pre- and post-procedural multidetector computed tomography (MDCT) of 28 SAVR patients and 212 TAVR patients were analyzed. Commissural alignment between the bioprosthetic (post) and native (pre) aortic valves was categorized as aligned (0° to 15° angle deviation) or as mild (15° to 30°), moderate (30° to 45°), or severe (45° to 60°) commissural misalignment (CMA).

Results

With SAVR, 27 of 28 cases (96%) were aligned and 1 had mild CMA. For all types of transcatheter heart valves (THVs), there was random valve implantation with regard to commissural alignment: 22% of THVs were aligned, 25% had mild CMA, 22% had moderate CMA, and 31% had severe CMA. The degree of commissural alignment was not associated with a difference in transvalvular gradient, paravalvular aortic regurgitation, or simulated coronary filling. However, there was a significantly higher rate of mild central aortic regurgitation in those THVs with moderate or greater CMA compared with those THV with mild or less CMA (7.8% vs. 1.1%; p = 0.03).

Conclusions

Commissural alignment is excellent in case of SAVR but random in case of TAVR. There is no association between CMA and transvalvular gradient or coronary filling; however, there is a significantly higher rate of mild central aortic regurgitation in case of moderate or greater CMA.  相似文献   

18.

Objectives

This study sought to evaluate the safety, feasibility, and outcomes of transcatheter pulmonary valve replacement (TPVR) in conduits ≤16 mm in diameter.

Background

The Melody valve (Medtronic, Minneapolis, Minnesota) is approved for the treatment of dysfunctional right ventricular outflow tract (RVOT) conduits ≥16 mm in diameter at the time of implant. Limited data are available regarding the use of this device in smaller conduits.

Methods

The study retrospectively evaluated patients from 9 centers who underwent percutaneous TPVR into a conduit that was ≤16 mm in diameter at the time of implant, and reported procedural characteristics and outcomes.

Results

A total of 140 patients were included and 117 patients (78%; median age and weight 11 years of age and 35 kg, respectively) underwent successful TPVR. The median original conduit diameter was 15 (range: 9 to 16) mm, and the median narrowest conduit diameter was 11 (range: 4 to 23) mm. Conduits were enlarged to a median diameter of 19 mm (29% larger than the implanted diameter), with no difference between conduits. There was significant hemodynamic improvement post-implant, with a residual peak RVOT pressure gradient of 7 mm Hg (p < 0.001) and no significant pulmonary regurgitation. During a median follow-up of 2.0 years, freedom from RVOT reintervention was 97% and 89% at 2 and 4 years, respectively, and there were no deaths and 5 cases of endocarditis (incidence rate 2.0% per patient-year).

Conclusions

In this preliminary experience, TPVR with the Melody valve into expandable small diameter conduits was feasible and safe, with favorable early and long-term procedural and hemodynamic outcomes.  相似文献   

19.

Objectives

This study investigated differences between transcatheter heart valve (THV) types and regarding debris captured by a cerebral embolic protection system (Claret Medical Sentinel, Santa Rosa, California).

Background

Differences of THV types and cerebral injury after transcatheter aortic valve replacement (TAVR) are not well understood.

Methods

A total of 246 patients pooled from 2 prospective studies (SENTINEL [Cerebral Protection in Transcatheter Aortic Valve Replacement] trial, N = 100; SENTINEL-H [Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement] trial, N = 146) were included in the analysis. Histopathologic assessment and histomorphometric analyses of debris were compared with THV types. Analyses were differentiated by particle size (≥150, ≥500, and ≥1,000 μm), particle count, total particle area, and maximum of largest dimension. Only commercially available THVs were included: 16% Evolut R (EvR), 15% Lotus, 59% SAPIEN 3 (S3), and 10% SAPIEN XT (XT).

Results

Particles were captured in 99% of patients. There was a significantly higher amount of debris related to the vascular bed (valve tissue, arterial wall, calcification) in EvR patients compared with S3 patients; 53% of all patients irrespective of valve type had at least 1 particle ≥1 mm. Larger particles (≥500 and ≥1,000 μm) were significantly more frequent in EvR than XT and S3 patients. Lotus patients with particles ≥1,000 μm were significantly more frequent than in S3 patients. Particle count, total particle area, and maximum of largest dimension were significantly higher in both Lotus and EvR patients compared with S3 and XT.

Conclusions

Debris was captured in 99% of patients, of whom 53% had at least 1 particle of debris >1 mm. The number and size of particles captured during a procedure in which EvR or Lotus THV was used were higher and larger than with a Sapien THV. Regardless, embolic debris, including large particles, is universal across valve types and provides mechanistic support for the potential benefit of using cerebral embolic protection in all TAVR procedures.  相似文献   

20.
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