Multidetector computed tomography (MDCT) plays a key role in patient assessment prior to transcatheter aortic valve implantation (TAVI). However, to date no consensus has been established on what is ...the optimal pre-procedural imaging protocol. Variability in pre-TAVI acquisition protocols may lead to discrepancies in aortic annulus measurements and may potentially influence prosthesis size selection.
The current study evaluates the magnitude of differences in aortic annulus measurements using max-systolic, end-diastolic, and non-ECG-synchronized imaging, as well as the impact of method on prosthesis size selection.
Fifty consecutive TAVI-candidates, who underwent retrospectively-ECG-gated CT angiography (CTA) of the aortic root, directly followed by non-ECG-synchronized high-pitch CT of the entire aorta, were retrospectively included. Aortic root dimensions were assessed at each 10% increment of the R-R interval (0-100%) and on the non-ECG-synchronized scan. Dimensional changes within the cardiac cycle were evaluated using a 1-way repeated ANOVA. Agreement in measurements between max-systole, end-diastole and non-ECG-synchronized scans was assessed with Bland-Altman analysis.
Maximal dimensions of the aortic root structures and minimum annulus-coronary ostia distances were measured during systole. Max-systolic measurements were significantly and substantially larger than end-diastolic (p<0.001) and non-ECG-synchronized measurements (p<0.001). Due to these discrepancies, the three methods resulted in the same prosthesis size selection in only 48-62% of patients.
The systematic differences between max-systolic, end-diastolic and non-ECG-synchronized measurements for relevant aortic annular dimensions are both statistically significant and clinically relevant. Imaging strategy impacts prosthesis size selection in nearly half the TAVI-candidates. End-diastolic and non-ECG-synchronized imaging does not provide optimal information for prosthesis size selection. Systolic image acquisition is necessary for assessment of maximal annular dimensions and minimum annulus-coronary ostia distances.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Background
The prevalence of valvular aortic stenosis (AS) increases as the population ages. Echocardiographic measurements of peak jet velocity (Vpeak), mean pressure gradient (Pmean), and aortic ...valve area (AVA) determine AS severity and play a pivotal role in the stratification towards valvular replacement. A multimodality imaging approach might be needed in cases of uncertainty about the actual severity of the stenosis.
Purpose
To compare four‐dimensional phase‐contrast magnetic resonance (4D PC‐MR), two‐dimensional (2D) PC‐MR, and transthoracic echocardiography (TTE) for quantification of AS.
Study Type
Prospective.
Population
Twenty patients with various degrees of AS (69.3 ± 5.0 years).
Field Strength/Sequences
4D PC‐MR and 2D PC‐MR at 3T.
Assessment
We compared Vpeak, Pmean, and AVA between TTE, 4D PC‐MR, and 2D PC‐MR. Flow eccentricity was quantified by means of normalized flow displacement, and its influence on the accuracy of TTE measurements was investigated.
Statistical Tests
Pearson's correlation, Bland–Altman analysis, paired t‐test, and intraclass correlation coefficient.
Results
4D PC‐MR measured higher Vpeak (r = 0.95, mean difference + 16.4 ± 10.7%, P <0.001), and Pmean (r = 0.92, mean difference + 14.9 ± 16.0%, P = 0.013), but a less critical AVA (r = 0.80, mean difference + 19.9 ± 20.6%, P = 0.002) than TTE. In contrast, unidirectional 2D PC‐MR substantially underestimated AS severity when compared with TTE. Differences in Vpeak between 4D PC‐MR and TTE showed to be strongly correlated with the eccentricity of the flow jet (r = 0.89, P <0.001). Use of 4D PC‐MR improved the concordance between Vpeak and AVA (from 0.68 to 0.87), and between PGmean and AVA (from 0.68 to 0.86).
Data Conclusion
4D PC‐MR improves the concordance between the different AS parameters and could serve as an additional imaging technique next to TTE. Future studies should address the potential value of 4D PC‐MR in patients with discordant echocardiographic parameters.
Level of Evidence: 2
Technical Efficacy: Stage 2
J. Magn. Reson. Imaging 2020;51:472–480.
Objectives
The aim was to assess long‐term outcome after deferring intervention of coronary lesions with a fractional flow reserve (FFR) value of >0.80 in a real‐world patient population and then to ...identify factors associated with deferred target lesion failure (DTLF).
Background
Deferring coronary interventions of intermediate lesions based on FFR measurement is safe, irrespective of the extent of coronary artery disease. However, FFR values near the cut‐off of >0.80 may have less favorable outcome.
Methods
A retrospective analysis was performed in patients with deferred coronary intervention based on FFR value >0.80. The primary endpoint was DTLF, a composite of acute coronary syndrome (ACS) and any coronary revascularization, related to the initially deferred stenosis.
Results
A total of 600 patients, mean age of 66 ± 10 years, and 751 coronary lesions with negative FFR values (mean 0.88 ± 0.04) were included. The mean follow‐up was 27 ± 15 months. DTLF occurred in 44 patients (7.3%), revascularization in 42 (7%), and ACS without revascularization in 2 patients (0.3%). Patients with DTLF more often had diabetes mellitus, previous coronary artery bypass grafting, multivessel disease (MVD), and lower FFR at inclusion. Multivariable regression analysis showed that lower deferred FFR values FFR 0.81–0.85: hazard ratio (HR) 2.79 (95% CI confidence interval; 1.46–5.32), p .002, MVD HR 1.98 (95% CI; 1.05–3.75), p .036, distal lesions HR 2.43 (95% CI; 1.29–4.57), p .006, and lesions located in a saphenous vein graft (SVG) HR 6.35 (95% CI; 1.81–22.28), p .004 were independent predictors for DTLF.
Conclusions
The long‐term rate of DTLF of initially deferred coronary lesions was 7.3%. Independent predictors for DTLF are lower deferred FFR value, the presence of MVD, distal lesions, and lesions in SVG.
When compared with older reports of untreated symptomatic aortic valve stenosis (AoS), urgent transcatheter aortic valve implantation (u-TAVI) seems to improve mortality rates. We performed a single ...centre, retrospective cohort analysis to characterize our u-TAVI population and to identify potential predictors of worse outcomes.
We performed a retrospective analysis of 631 consecutive TAVI patients between 2013 and 2018. Of these patients, 53 were categorized as u-TAVI. Data was collected from the local electronic database.
Urgent patients had more often a severely decreased left ventricular ejection fraction (LVEF < 30%) and increased creatinine levels (115.5 88-147 vs 94.5 78-116 mmol/l; p = 0.001). Urgent patients were hospitalised for 18 10-28 days before and discharged 6 4-9 days after the implantation. The incidence of peri-procedural complications and apical implantations was comparable among the study groups. Urgent patients had higher in-hospital (11.3% vs 3.1%; p = 0.011) and 1-year mortality rates (28.2% vs 8.5%, p < 0.001). An increased risk of one-year mortality was associated with urgency (HR 3.5; p < 0.001), apical access (HR 1.9; p = 0.016) and cerebrovascular complications (HR 4.3; p = 0.002). Within the urgent group, the length of pre-hospital admission was the only significant predictor of 1-year mortality (HR 1.037/day; p = 0.003).
Compared to elective procedures, u-TAVI led to increased mortality and comparable complication rates. This detrimental effect is most likely related to the length of pre-procedural hospitalisation of urgent patients.
Background Despite improving experience and techniques, ischemic and bleeding complications after transcatheter aortic valve implantation (TAVI) remain prevalent and impair survival. Current ...guidelines recommend the temporary addition of clopidogrel in the initial period after TAVI to prevent thromboembolic events. However, explorative studies suggest that this is associated with a higher rate of major bleeding without a decrease in thromboembolic complications. Methods The POPular TAVI trial is a prospective randomized, controlled, open-label multicenter clinical trial to test the hypothesis that monotherapy with aspirin or oral anticoagulation (OAC) after TAVI is safer than the addition of clopidogrel for 3 months, without compromising clinical benefit. This trial encompasses 2 cohorts: cohort A, patients are randomized 1:1 to aspirin vs aspirin + clopidogrel, and cohort B, patients on OAC therapy are randomized 1:1 to OAC vs OAC + clopidogrel. Primary outcome is freedom from non–procedure-related bleeding at 1 year. Secondary net-clinical benefit outcome is freedom from the composite of cardiovascular death, non–procedural-related bleeding, myocardial infarction, or stroke at 1 year. The primary outcome is analyzed for superiority, whereas the secondary outcome is analyzed for noninferiority. Recruitment began in February 2014, and the trial will continue until a total of 1,000 patients (684 expected in cohort A and 316 in cohort B) are included and followed up for 1 year. Summary The POPular TAVI trial (NCT02247128) is the first large randomized controlled trial to test if monotherapy with aspirin or OAC vs additional clopidogrel after TAVI reduces bleeding with a favorable net-clinical benefit.
Background Limited clinical evidence and literature are available about the potential impact of sex on permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI). The ...aim of this work was to evaluate the relationship between sexes and atrioventricular conduction disturbances requiring PPI after TAVI. Methods and Results Data were obtained from 46 studies from PubMed reporting information about the impact of patient sex on PPI after TAVI. Total proportions with 95% Cls were reported. Funnel plot and Egger test were used for estimation of publication bias. The primary end point was 30-day or in-hospital PPI after TAVI, with odds ratios and 95% CIs extracted. A total of 70 313 patients were included, with a cumulative proportion of 51.5% of women (35 691 patients; 95% CI, 50.2-52.7). The proportion of women undergoing TAVI dropped significantly over time (
<0.0001). The cumulative PPI rate was 15.6% (95% CI, 13.3-18.3). The cumulative rate of PPI in women was 14.9% (95% CI, 12.6-17.6), lower than in men (16.6%; 95% CI, 14.2-19.4). The risk for post-TAVI PPI was lower in women (odds ratio, 0.90; 95% CI, 0.84-0.96
=0.0022). By meta-regression analysis, age (
=0.874) and ventricular function (
=0.302) were not significantly associated with PPI among the sexes. Balloon-expandable TAVI significantly decrease the advantage of women for PPI, approaching the same rate as in men (
=0.0061). Conclusions Female sex is associated with a reduced rate of PPI after TAVI, without influence of age or ventricular function. Balloon-expandable devices attenuate this advantage in favor of women. Additional investigations are warranted to elucidate sex-based differences in developing conduction disturbances after TAVI.
The impact of advanced age on the optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary revascularization (PCI) is still ...greatly debated. Therefore, the aim of the present sub-analysis of the REDUCE trial was to assess the impact of age on the comparison between a short 3 months vs standard 12 months DAPT in ACS patients treated with the COMBO Dual Stent Therapy.
The REDUCE trial is a prospective, multicenter, investigator-initiated study that randomized ACS patients undergoing PCI with the COMBO drug eluting stent to either 3 or 12 months of DAPT. The study population was divided according to age (<or ≥ 75 years). Primary study endpoint was a composite of all-cause mortality, myocardial infarction, definite/probable stent thrombosis (ST), stroke, target-vessel revascularization (TVR) and bleeding (BARC II, III, V) at 12 months. Secondary endpoints were cardiovascular mortality and the individual components of the primary endpoint within 24 months.
From June 2014 to May 2016, 1496 patients were included in the study, of whom 205 (13.7%) ≥75 years of age. Among them, 50.7% of the elderly and 50.2% of younger patients were assigned to the 3-month DAPT treatment. Baseline characteristics were well matched between the two arms, except for a higher rate of males (p=0.02) and a reduced number of lesions on the right coronary artery (p=0.02) in elderly patients treated for the short DAPT duration. Median follow-up was 682.5 days IQR:667-731. At 12 months, no difference in the primary endpoint was observed according to DAPT duration in both patients aged ≥75 years (22.1% vs 18.8%, HR 95%CI = 1.6 0.73–3.5, p=0.24) and younger ones (9.7% vs 10.9%, HR 95%CI = 0.85 0.59–1.27, p=0.44; p INT = 0.15). Results were confirmed after correction for baseline differences among the elderly (adjusted HR 95%CI = 1.7 0.75–3.9, p=0.21). Comparable rates of survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events were observed with the two DAPT strategies, with no impact of age.
The present study shows that among ACS patients randomized in the REDUCE trial, a 3-month DAPT strategy was comparable to a standard 12-month DAPT at a 2-year follow-up for both ischemic and bleeding endpoints, in elderly and younger patients. Thus, despite presenting the limitations of a subgroup analysis, our study strengthens the feasibility of a shorter DAPT duration even among high-risk subsets of ACS patients.
Display omitted
•Advanced age enhances the bleeding risk associated with dual antiplatelet therapy.•The optimal duration of dual antiplatelet therapy in elderly patients with acute coronary syndromes (ACS) is debated.•The REDUCE trial compared 3 vs 12 months DAPT in ACS patients treated with the COMBO Dual Stent Therapy.•We provide a sub-analysis of the REDUCE trial according to age.•No age-related difference was observed in the primary composite or individual thrombotic and bleeding endpoints at 12 months.
Background
The safety of administration of tirofiban, a platelet glycoprotein IIb/IIIa inhibitor, followed by a clopidogrel loading dose in clopidogrel-naïve patients undergoing ad-hoc percutaneous ...coronary intervention (PCI) is not yet clear.
Methods
In a retrospective observational cohort analysis, clopidogrel-naïve patients undergoing ad-hoc PCI who received a high-dose bolus of tirofiban (25 μg/kg) followed by a 600-mg clopidogrel loading dose (group 1) were compared with patients undergoing elective PCI who were pretreated with clopidogrel (group 2), between September 2014 and October 2021. The primary outcome was major adverse cardiovascular events (MACE) defined as the composite of death, myocardial infarction, stroke, target-lesion revascularisation and bleeding at 30 days. Secondary outcomes were MACE at 7 days and individual components of the primary outcome at 7 and 30 days.
Results
A total of 1404 patients were included: 432 (31%) in group 1 and 972 (69%) in group 2. Median age was 69 years, and 28% were female. At 7‑day follow-up, MACE occurred in 1.4% in group 1 versus 3.0% in group 2 (
p
= 0.08). 30-day MACE were observed in 1.9% in group 1 and 4.2% in group 2 (
p
= 0.03). Secondary outcomes were comparable between the groups. Cox regression analysis, corrected for baseline differences, revealed no significant difference in the primary outcome (hazard ratio: 1.8; 95% confidence interval: 0.8–3.9).
Conclusion
Ad-hoc PCI in clopidogrel-naïve patients who were treated with high-dose bolus of tirofiban followed by a clopidogrel loading dose immediately after the procedure appeared to be safe.
Access-site-related complications are often related to high-risk anatomy and technical pitfalls and impair the outcomes of transfemoral aortic valve implantations (TAVIs). Calcification and ...tortuosity are widely recognized risk factors, and their impact on procedural planning is left to the implanting experts’ discretion. To facilitate decision-making, we introduced a quantitative measure for iliofemoral tortuosity and assessed its predictive value for access-site-related vascular and bleeding complications.
We performed a single-centre prospective cohort study of consecutive, percutaneous transfemoral TAVI performed between April 2019 and March 2020. Medical history and all-cause mortality were extracted from the electronic patient files. Arterial anatomy and calcifications were evaluated using 3mensio Structural Heart software. The primary outcome was access-site-related vascular or bleeding complications.
In this elderly, intermediate-risk population, we registered the primary outcome in 43 patients (39%), and major access-site complications in 10 patients (9.2%). Complete hemostasis was achieved in 77 patients (70.6%), by the application of the MANTA plug alone. In the group with access-site-related adverse events, compared with the group without, the tortuosity index was higher (26% 18%-33% vs 19% 13%-29%, respectively; P = 0.012), as was maximal angulation (50° 40°-59° vs 43° 36°-51°, respectively; P = 0.026) were higher. Both variables had a significant effect on our primary outcome, with odds ratios (OR) of 3.1 (tortuosity, P = 0.005) and 2.6 (angulation, P = 0.020). The degree of angulation was a predictor of major complications too (odds ratio 7 1.4-34.8; P = 0.017).
Steeper angles and greater arterial elongation increase the risk of vascular and bleeding complications after femoral TAVI with the utilization of a plug-based closure device.
Les complications liées au site d’accès qui sont souvent associées à une anatomie qui expose à des risques élevés et aux pièges techniques nuisent aux résultats cliniques des implantations valvulaires aortiques par voie fémorale (TAVI, de l’anglais transfemoral aortic valve implantation). Il est largement reconnu que la calcification et la tortuosité sont des facteurs de risque. Par conséquent, leurs conséquences sur la planification interventionnelle sont laissées à la discrétion des experts en implantation. Pour faciliter la prise de décision, nous avons mis en place une mesure quantitative de tortuosités iliofémorales et évalué sa valeur prédictive sur la survenue de complications vasculaires et hémorragiques liées au site d’accès.
Nous avons réalisé une étude de cohorte prospective unicentrique de TAVI percutanées par voie fémorale consécutives effectuées entre avril 2019 et mars 2020. Nous avons extrait les antécédents médicaux et la mortalité toutes causes confondues des dossiers médicaux électroniques. Nous avons évalué l’anatomie artérielle et les calcifications à l’aide du logiciel 3mensio Structural Heart. Le critère de jugement principal était les complications vasculaires ou hémorragiques liées au site d’accès.
Dans cette population âgée exposée à un risque intermédiaire, nous avons enregistré le critère de jugement principal de 43 patients (39 %), et les principales complications du site d’accès de 10 patients (9,2 %). Soixante-dix-sept patients (70,6 %) ont obtenu l’hémostase complète par la seule application du bouchon MANTA. L’indice de tortuosité était plus élevé dans le groupe qui avait subi des événements défavorables liés au site d’accès que dans le groupe qui n’avait pas subi d’événements défavorables (26 % 18 %-33 % vs 19 % 13 %-29 %, respectivement; P = 0,012). Il en était de même pour l’angulation maximale (50° 40°-59° vs 43° 36°-51°, respectivement; P = 0,026) qui était plus grande. Les 2 variables ont eu des effets significatifs sur le critère de jugement principal, soit des rapports de cotes (RC) de 3,1 (tortuosité, P = 0,005) et de 2,6 (angulation, P = 0,020). Le degré d’angulation était aussi un prédicteur de complications majeures (rapport de cotes 7 1,4-34,8; P = 0,017).
Des angles plus prononcés et une plus grande élongation des artères augmentent le risque de complications vasculaires et hémorragiques après la TAVI par voie fémorale lors de l’utilisation d’un dispositif de fermeture à bouchon.
Incorrect prosthesis size has direct impact on patient outcome after transcatheter aortic valve implantation (TAVI) procedure. Currently, annular diameter, area or perimeter may be used for ...prosthesis size selection. The aim was to evaluate whether the use different annular dimensions would result in the selection of different prosthesis sizes, when assessed in the same TAVI-candidate during the same phase of a cardiac cycle. Fifty consecutive TAVI-candidates underwent retrospectively ECG-gated computed tomography angiography (CTA). Aortic root dimensions were assessed in the 20% phase of the R–R interval. Annular short diameter, perimeter and area were used to select the prosthesis size, based on the industry recommendations for a self-expandable (Medtronic CoreValve; MCV) and balloon-expandable (Edwards Sapien XT Valve; ESV) valve. Complete agreement on selected prosthesis size amongst all three annular dimensions was observed in 62% (31/50; ESV) and 30% (15/50; MCV). Short aortic annulus measurement resulted in a smaller prosthesis size in 20% (10/50; ESV) and in 60% of cases (30/50; MCV) compared to the size suggested by both annular perimeter and area. In 18% (9/50; ESV) and 10% of cases (5/50; MCV) a larger prosthesis would have been selected based on annular perimeter compared to annular diameter and area. Prosthesis size derived from area was always in agreement with at least one other parameter in all cases. Aortic annulus area appears to be the most robust parameter for TAVI-prosthesis size selection, regardless of the specific prosthesis size. Short aortic annulus diameter may underestimate the prosthesis size, while use of annular perimeter may lead to size overestimation in some cases.
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