Abstract
Aims
We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses valve-in-valve (ViV), failed annuloplasty rings ...valve-in-ring (ViR), and severe mitral annular calcification valve-in-mitral annular calcification (ViMAC).
Methods and results
From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; P < 0.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; P < 0.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; P < 0.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; P = 0.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30 days (34.5% vs. 9.9% vs. 6.2%; log-rank P < 0.001) and 1 year (62.8% vs. 30.6% vs. 14.0%; log-rank P < 0.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27–3.12; P = 0.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29–8.51; P < 0.001.
Conclusion
The TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.
Transcatheter aortic valve replacement (TAVR) is being increasingly performed in patients with bicuspid aortic valve stenosis (AS).
This study sought to compare the procedural and clinical outcomes ...in patients with bicuspid versus tricuspid AS from the Bicuspid AS TAVR multicenter registry.
Outcomes of 561 patients with bicuspid AS and 4,546 patients with tricuspid AS were compared after propensity score matching, assembling 546 pairs of patients with similar baseline characteristics. Procedural and clinical outcomes were recorded according to Valve Academic Research Consortium-2 criteria.
Compared with patients with tricuspid AS, patients with bicuspid AS had more frequent conversion to surgery (2.0% vs. 0.2%; p = 0.006) and a significantly lower device success rate (85.3% vs. 91.4%; p = 0.002). Early-generation devices were implanted in 320 patients with bicuspid and 321 patients with tricuspid AS, whereas new-generation devices were implanted in 226 and 225 patients with bicuspid and tricuspid AS, respectively. Within the group receiving early-generation devices, bicuspid AS had more frequent aortic root injury (4.5% vs. 0.0%; p = 0.015) when receiving the balloon-expanding device, and moderate-to-severe paravalvular leak (19.4% vs. 10.5%; p = 0.02) when receiving the self-expanding device. Among patients with new-generation devices, however, procedural results were comparable across different prostheses. The cumulative all-cause mortality rates at 2 years were comparable between bicuspid and tricuspid AS (17.2% vs. 19.4%; p = 0.28).
Compared with tricuspid AS, TAVR in bicuspid AS was associated with a similar prognosis, but lower device success rate. Procedural differences were observed in patients treated with the early-generation devices, whereas no differences were observed with the new-generation devices.
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Limited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR).
This study sought to compare the outcomes of TAVR ...with early- and new-generation devices in symptomatic patients with pure native AR.
From the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices.
A total of 331 patients with a mean STS score of 6.7 ± 6.7 underwent TAVR. The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively. STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs. 7.6 ± 6.7; p = 0.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; p < 0.001). Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; p < 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; p = 0.007) and post-procedural AR ≥ moderate (4.2% vs. 18.8%; p < 0.001). There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural AR ≥ moderate compared with those with post-procedural AR ≤ mild (46.1% vs. 21.8%; log-rank p = 0.001). On multivariable analysis, post-procedural AR ≥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; p = 0.001).
Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality.
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New-onset conduction disturbances still represent a considerable problem after transcatheter aortic valve implantation (TAVI). The aim of this study was to identify calcification patterns with an ...elevated risk for permanent pacemaker implantation (PPI) after TAVI and investigate underlying mechanisms in an ex vivo setting.
One hundred and sixty-two patients who underwent TAVI with the Edwards SAPIEN XT
or Medtronic CoreValve
at our institution were analysed. The calcium load of the device landing zone was quantified with 3mensio
, and calcium patterns with an elevated risk for PPI were identified. Ex vivo simulations of balloon valvuloplasty were performed in 3D-printed silicone annuli of patients matching the identified risk profile. Patients with a calcium load of the left coronary cusp (LCC) above 209 mm
had a higher rate of PPI than patients below this threshold (16.7 vs. 2.6%, P = 0.003). Multivariate regression revealed pre-existing right bundle branch block (RBBB) and increased LCC calcification as independent predictors for PPI. Simulation of the TAVI procedure in a silicone annulus revealed an off-centreline shift of the valvuloplasty balloon and transcatheter heart valve away from the LCC towards the commissure between right- and non-coronary cusp.
Pre-existing RBBB and elevated LCC calcification were identified as independent predictors for PPI. These two risk factors enabled us to distinguish between patients according to their risk for PPI after TAVI. Ex vivo simulations suggested an off-centreline shift of the balloon as a possible explanation.
Abstract
OBJECTIVES:
Surgical aortic valve replacement (sAVR) is coming under close scrutiny with the recent upswing in the use of less invasive approaches. The aim of this analysis was to identify ...current trends in patient selection, procedural characteristics and outcomes after sAVR in Germany.
METHODS:
We analysed data from 42 776 patients included in the German Aortic Valve Registry who underwent sAVR with and without coronary artery bypass surgery (CABG) between 2011 and 2015. Baseline, procedural and short-term outcome parameters were analysed.
RESULTS:
Of all registered patients, 26 618 (62.2%) underwent isolated sAVR and 16 158 (37.8%) sAVR + CABG. The median age was 72 years, and the median Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) was 2.3%. From 2011 to 2015, there was a decline in STS PROM (2.4–2.2%, P < 0.001) and a decline in risk factors, such as pulmonary hypertension (9.1–3.2%, P < 0.001), occlusive arterial disease (19.6–17.7%, P = 0.003), mitral regurgitation ≥2° (10.6–7.6%, P < 0.001) and New York Heart Association Class III/IV (65.3–59.2%, P < 0.001). In-hospital mortality was 2.3%, 1.3% had disabling stroke, 0.4% residual aortic regurgitation ≥2°, and the incidence of new-onset pacemaker/implantable cardioverter–defibrillator implantation was 3.9%. There was an increase in the use of biological valves in patients <65 years (50.1–65.7%, P < 0.001), and the proportion of rapid deployment valves increased significantly (1.5–8.4%, P < 0.001) over the investigated time period.
CONCLUSIONS:
Both isolated sAVR as well as sAVR + CABG resulted in excellent in-hospital outcomes based on >42 000 patients treated between 2011 and 2015. The implementation of alternative treatment strategies has resulted in palpable changes in patient and device selection.
Anatomically pre-shaped sinus prostheses (SP) were developed to mimic the aortic sinus with the goal to preserve near physiological hemodynamic conditions after valve-sparing aortic root replacement. ...Although SP have shown more physiological flow patterns, a comparison to straight tube prosthesis and the analysis of derived quantitative parameters is lacking. Hence, this study sought to analyze differences in aortic wall shear stress (WSS) between anatomically pre-shaped SP, conventional straight tube prostheses (TP), and age-matched healthy subjects) using time-resolved 3-dimensional flow cardiovascular magnetic resonance (4D Flow CMR). Moreover, the WSS gradient was introduced and analyzed regarding its sensitivity to detect changes in hemodynamics and its dependency on the expression of secondary flow patterns.
Twelve patients with SP (12 male, 62 ± 9yr), eight patients with TP (6 male, 59 ± 9yr), and twelve healthy subjects (2 male, 55 ± 6yr) were examined at 3 T with a 4D Flow CMR sequence in this case control study. Six analysis planes were placed in the thoracic aorta at reproducible landmarks. The following WSS parameters were recorded: WSS
(spatially averaged over the contour at peak systole), max. WSS
(maximum segmental WSS), min. WSS
(minimum segmental WSS) and the WSS Gradient, calculated as max. WSS
- min. WSS
. Kruskal-Wallis- and Mann-Whitney-U-Test were used for statistical comparison of groups. Occurrence and expression of secondary flow patterns were evaluated and correlated to WSS values using Spearman's correlation coefficient.
In the planes bordering the prosthesis all WSS values were significantly lower in the SP compared to the TP, approaching the physiological optimum of the healthy subjects. The WSS gradient showed significantly different values in the four proximally localized contours when comparing both prostheses with healthy subjects. Strong correlations between an elevated WSS gradient and secondary flow patterns were found in the ascending aorta and the aortic arch.
Overall, the SP has a positive impact on WSS, most pronounced at the site and adjacent to the prosthesis. The WSS gradient differed most obviously and the correlation of the WSS gradient with the occurrence of secondary flow patterns provides further evidence for linking disturbed flow, which was markedly increased in patients compared to healthy sub jects, to degenerative remodeling of the vascular wall.
This study sought to compare patient characteristics, procedural outcomes, and valve hemodynamics of surgical aortic valve replacement (SAVR) with current-generation rapid-deployment valves (RDVs) ...versus transcatheter aortic valve replacement (TAVR) with current-generation transcatheter heart valves (THVs).
The patient population currently treated with RDVs may have potential similarities with the current TAVR population, but comparative studies in a large patient population remain scarce.
A total of 16,473 patients who underwent isolated SAVR using current-generation RDVs or isolated transfemoral TAVR with current-generation THVs between 2011 and 2017 were enrolled into the German Aortic Valve Registry. Baseline, procedural, and in-hospital outcome parameters were analyzed for RDVs and THVs before and after 1:1 propensity score matching. Furthermore, RDVs and THVs with similar design characteristics were compared with each other.
A total of 1,743 patients received SAVR with an RDV, whereas 14,730 patients were treated with transfemoral TAVR. Patients treated with TAVR were significantly older and had higher surgical risk scores. Following valve replacement, patients treated with an RDV had a significantly higher rate of disabling stroke (1.7% vs. 1.1%; p = 0.03), need for transfusion of >4 red blood cell units (8.5% vs. 1.4%; p < 0.001), and new onset renal replacement therapy (1.9% vs. 1.2%; p = 0.01), whereas the need for a new permanent pacemaker was lower (8.4% vs. 14.9%; p < 0.001). In-hospital mortality was similar (1.6% vs. 1.8%; p = 0.62). These findings persisted after 1:1 propensity score matching, but in-hospital mortality was significantly higher after RDVs (1.7% vs. 0.6%; p = 0.003). Balloon-expandable (BE) RDVs had significantly lower residual gradients compared with BE-THVs, while self-expanding (SE)-RDVs had significantly higher residual gradients compared with SE-THVs.
In a large all-comers’ registry, TAVR with current-generation THVs was associated with improved in-hospital outcomes compared with SAVR with current-generation RDVs. The pacemaker rate is significantly higher with TAVR. Post-procedural hemodynamic function varied between individual RDVs and THVs.
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IntroductionDrug therapy to reduce the regurgitation fraction (RF) of high-grade aortic regurgitation (AR) by increasing heart rate (HR) is generally recommended. However, chronic HR reduction in ...HFREF patients can significantly improve aortic compliance and thereby potentially decrease RF. To clarify these contrasts, we examined the influence of HR, aortic compliance and stroke volume (SV) on RF in an ex vivo porcine model of severe AR.MethodsExperiments were performed on porcine ascending aorta with aortic valves (n=12). Compliance was varied by inserting a Dacron graft close to the aortic valve. Both tube systems were connected to a left heart simulator varying HR and SV. AR was accomplished by punching a 0.3 cm2 hole in one aortic cusp. Flow, RF, SV and aortic pressure were measured, aortic compliance with transoesophageal ultrasound probes.ResultsCompliance of the aorta was significantly reduced after Dacron graft insertion (0.55%±0.21%/mm Hg vs 0.01%±0.007%/mm Hg, p<0.001, respectively). With increasing HR, RF was significantly reduced in each steady state of the native aorta (HR 40 bpm: 88%±7% vs HR 120 bpm: 42%±10%; p<0.001), but Dacron tube did not affect RF (HR 40 bpm: 87%±8%; p=0.79; HR 120 bpm: 42%±3%; p=0.86). Increasing SV also reduced RF independent of the stiff Dacron graft.ConclusionAortic compliance did not affect AR in the ex vivo porcine model of AR. RF was significantly reduced with increasing HR and SV. These results affirm that HR lowering and negative inotropic drugs should be avoided to treat severe AR.
Background For nonagenarians with symptomatic severe aortic stenosis transcatheter aortic valve implantation (TAVI) has become a feasible therapeutic option. Therefore, the aim of this study was to ...evaluate the procedural outcomes and mid-term follow-up in this patient group and compare this to octogenarians. Methods From 1359 patients who underwent TAVI at our institution between March 2009 and February 2016, 82 patients were nonagenarians and 912 were octogenarians. In nonagenarians, mean age was 91.9 ± 1.4 years and compared to octogenarians showed a significantly higher logistic EuroScore (27.7 ± 14.8% vs. 23.1 ± 14.4, p = 0.005) and STS Score (8.5 ± 4.8% vs. 6.3 ± 6.7, p = 0.001). Results There were no significant differences with regard to stroke rate, pacemaker implantation rate and major vascular complications between the two groups. Thirty-day mortality was 9.8% in nonagenarians and 4.1% in octogenarians (p = 0.04). At one year, all-cause mortality increased to 30.9% vs. 18.6% (n.s.). Conclusion Nonagenarians showed an increased periprocedural mortality during TAVI and higher mortality in follow-up compared to octogenarians. Age alone is not a predictive factor but indication for treatment should be carefully evaluated by the heart team on an individual basis.
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