A valve-in-valve (ViV) transcatheter aortic valve implantation with lithotripsy-assisted transfemoral approach.
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ABSTRACT:
SUBMITTER: Tsanaxidis N
PROVIDER: S-EPMC7649463 | biostudies-literature | 2020 Oct
REPOSITORIES: biostudies-literature
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A valve-in-valve (ViV) transcatheter aortic valve implantation with lithotripsy-assisted transfemoral approach.
Tsanaxidis Nikolaos N Wrigley Benjamin B Collins Michael M Cotton James J
European heart journal. Case reports 20200907 5
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Project description:BackgroundDiabetes Mellitus (DM) affects a third of patients with symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI). DM is a well-known risk factor for cardiac surgery, but its prognostic impact in TAVI patients remains controversial. This study aimed to evaluate outcomes in diabetic patients undergoing TAVI.MethodsThis multicentre registry includes data of > 12,000 patients undergoing transfemoral TAVI. We assessed baseline patient characteristics and clinical outcomes in patients with DM and without DM. Clinical outcomes were defined by the second valve academic research consortium. Propensity score matching was applied to minimize potential confounding.ResultsOf the 11,440 patients included, 31% (n = 3550) had DM and 69% (n = 7890) did not have DM. Diabetic patients were younger but had an overall worse cardiovascular risk profile than non-diabetic patients. All-cause mortality rates were comparable at 30 days (4.5% vs. 4.9%, RR 0.9, 95%CI 0.8-1.1, p = 0.43) and at one year (17.5% vs. 17.4%, RR 1.0, 95%CI 0.9-1.1, p = 0.86) in the unmatched population. Propensity score matching obtained 3281 patient-pairs. Also in the matched population, mortality rates were comparable at 30 days (4.7% vs. 4.3%, RR 1.1, 95%CI 0.9-1.4, p = 0.38) and one year (17.3% vs. 16.2%, RR 1.1, 95%CI 0.9-1.2, p = 0.37). Other clinical outcomes including stroke, major bleeding, myocardial infarction and permanent pacemaker implantation, were comparable between patients with DM and without DM. Insulin treated diabetics (n = 314) showed a trend to higher mortality compared with non-insulin treated diabetics (n = 701, Hazard Ratio 1.5, 95%CI 0.9-2.3, p = 0.08). EuroSCORE II was the most accurate risk score and underestimated 30-day mortality with an observed-expected ratio of 1.15 in DM patients, STS-PROM overestimated actual mortality with a ratio of 0.77 and Logistic EuroSCORE with 0.35.ConclusionDM was not associated with mortality during the first year after TAVI. DM patients undergoing TAVI had low rates of mortality and other adverse clinical outcomes, comparable to non-DM TAVI patients. Our results underscore the safety of TAVI treatment in DM patients.Trial registrationThe study is registered at clinicaltrials.gov (NCT03588247).
| S-EPMC9670618 | biostudies-literature
Project description:BackgroundThe presence of severe calcific atherosclerosis at the iliofemoral axis may preclude transcatheter aortic valve implantation (TAVI) by the transfemoral (TF) approach. Intravascular lithotripsy (IVL) is a novel technology that fractures intimal/medial calcium and increases vessel compliance allowing TF TAVI in selected patients with peripheral artery disease (PAD).AimsThe aim of this study was to report on the safety and efficacy of IVL-assisted TF TAVI in an all-comers population.MethodsClinical, imaging and procedural data on all consecutive patients treated by IVL-assisted TF TAVI in six high-volume European centres (2018-2020) were collected in this prospective, real-world, multicentre registry.ResultsIVL-assisted TF TAVI was performed in 108 patients, increasing from 2.4% to 6.5% of all TAVI from 2018 to 2020, respectively. The target lesion was most often localised at the common and/or external iliac artery (93.5% of cases; average TL-MLD 4.6±0.9 mm with 318 degrees of calcium arc). Transfemoral aortic valve delivery was successful in 100% of cases; final procedural success in 98.2% (two conversions to cardiac open surgery for annular rupture and valve migration). Complications of the IVL-treated segments consisted of 1 perforation and 3 major dissections requiring stent implantation (2 covered stents and 2 BMS). Access-site-related complications included 3 major bleedings. Three in-hospital deaths were recorded (2.8%, 1 failed surgical conversion after annular rupture, 1 cardiac arrest after initial valvuloplasty, 1 late hyperkalaemia in renal dysfunction).ConclusionsIVL-assisted TF TAVI proved to be a safe and effective approach, which helps to expand the indications for TF TAVI in patients with severe calcific PAD. However, these patients continue to have a higher-than-average incidence of periprocedural complications.
| S-EPMC9896402 | biostudies-literature
Project description:BackgroundThe subclavian artery is an alternative access route for transcatheter aortic valve implantation (TAVI), with a potential advantage in patients unsuitable for traditional access routes such as the femoral artery. This study aimed to determine the safety and efficacy of the trans-subclavian (TSc) compared to the trans-femoral (TF) approach.MethodsA systematic review was conducted on two online databases: Embase and Medline. The initial search returned 508 titles. Nine observational studies were included: n = 2938 patients (2382 TF and 556 TSc).ResultsBoth TSc and TF groups were comparable for: 30-day mortality (Odds ratio, OR 0.75, 95% CI 0.49 - 1.16, p = 0.195); in-hospital stroke (OR 1.05, 95% CI 0.60-1.85, p = 0.859); myocardial infarction (OR 1.97, 95% CI 0.74-5.23, p = 0.176); paravalvular leaks (OR 1.20, 95% CI 0.76-1.90, p = 0.439); rates of postoperative permanent pacemaker implantation (OR 1.49, 95% CI 0.92-2.41, p = 0.105); in-hospital bleeding and meta-analysis demonstrated no significant difference between access points (OR 3.44, 95% CI 0.35-34.22, p = 0.292). Procedural time was found to be longer in the TSc group (SMD 1.02; 95% CI 0.815-1.219, p < 0.001). Major vascular complications were significantly higher in the TF group (OR 0.55, 95% CI 0.32-0.94, p = 0.029). Meta regression found no influence of the covariates on the outcomes.ConclusionSubclavian access is both a safe and feasible alternative access route for TAVI with lower risks of major vascular complications. This study supports the use of subclavian access as a viable alternative in patient groups where transfemoral TAVI is contraindicated.
| S-EPMC7653062 | biostudies-literature
Project description:BACKGROUND:Immobilisation of patients after transfemoral transcatheter aortic valve implantation (TF-TAVI) is the standard of care, mostly to prevent vascular complications. However, immobilisation may increase post-operative complications such as delirium and infections. In this trial, we determine whether it is feasible and safe to implement early ambulation after TF-TAVI. METHODS:We prospectively included TF-TAVI patients from 2016 to 2018. Patients were assessed for eligibility using our strict safety protocol and were allocated (based on the time at which the procedure ended) to the EARLY or REGULAR group. RESULTS:A total of 150 patients (49%) were deemed eligible for early mobilisation, of which 73 were allocated to the EARLY group and 77 to the REGULAR group. The overall population had a mean age of 80 years, 48% were male with a Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score of 3.8?±?1.8. Time to mobilisation was 4?h 49?min?±?31?min in the EARLY group versus 20?h 7?min?±?3?h 6?min in the REGULAR group (p?<?0.0001). There were no differences regarding the primary endpoint. No major vascular complications occurred and a similar incidence of minor vascular complications was seen in both groups (4/73 [5.5%] vs 6/77 [7.8%], p?=?0.570). The incidence of the combined secondary endpoint was lower in the EARLY group (p?=?0.034), with a numerically lower incidence for all individual outcomes (delirium, infections, pain and unplanned urinary catheter use). CONCLUSION:Early mobilisation (ambulation 4-6?h post-procedure) of TF-TAVI patients is feasible and safe. Early ambulation decreases the combined incidence of delirium, infections, pain and unplanned urinary catheter use, and its adoption into contemporary TAVI practice may therefore be beneficial.
| S-EPMC7190768 | biostudies-literature
Project description:AimsSystemic inflammatory response, identified by increased total leucocyte counts, was shown to be a strong predictor of mortality after transcatheter aortic valve implantation (TAVI). Yet the mechanisms of inflammation-associated poor outcome after TAVI are unclear. Therefore, the present study aimed at investigating individual inflammatory signatures and functional heterogeneity of circulating myeloid and T-lymphocyte subsets and their impact on 1 year survival in a single-centre cohort of patients with severe aortic stenosis undergoing TAVI.Methods and resultsOne hundred twenty-nine consecutive patients with severe symptomatic aortic stenosis admitted for transfemoral TAVI were included. Blood samples were obtained at baseline, immediately after, and 24 h and 3 days after TAVI, and these were analysed for inflammatory and cardiac biomarkers. Myeloid and T-lymphocyte subsets were measured using flow cytometry. The inflammatory parameters were first analysed as continuous variables; and in case of association with outcome and area under receiver operating characteristic (ROC) curve (AUC) ≥ 0.6, the values were dichotomized using optimal cut-off points. Several baseline inflammatory parameters, including high-sensitivity C-reactive protein (hsCRP; HR = 1.37, 95% CI: 1.15-1.63; P < 0.0001) and IL-6 (HR = 1.02, 95% CI: 1.01-1.03; P = 0.003), lower counts of Th2 (HR = 0.95, 95% CI: 0.91-0.99; P = 0.009), and increased percentages of Th17 cells (HR = 1.19, 95% CI: 1.02-1.38; P = 0.024) were associated with 12 month all-cause mortality. Among postprocedural parameters, only increased post-TAVI counts of non-classical monocytes immediately after TAVI were predictive of outcome (HR = 1.03, 95% CI: 1.01-1.05; P = 0.003). The occurrence of SIRS criteria within 48 h post-TAVI showed no significant association with 12 month mortality (HR = 0.57, 95% CI: 0.13-2.43, P = 0.45). In multivariate analysis of discrete or dichotomized clinical and inflammatory variables, the presence of diabetes mellitus (HR = 3.50; 95% CI: 1.42-8.62; P = 0.006), low left ventricular (LV) ejection fraction (HR = 3.16; 95% CI: 1.35-7.39; P = 0.008), increased baseline hsCRP (HR = 5.22; 95% CI: 2.09-13.01; P < 0.0001), and low baseline Th2 cell counts (HR = 8.83; 95% CI: 3.02-25.80) were significant predictors of death. The prognostic value of the linear prediction score calculated of these parameters was superior to the Society of Thoracic Surgeons score (AUC: 0.88; 95% CI: 0.78-0.99 vs. 0.75; 95% CI: 0.64-0.86, respectively; P = 0.036). Finally, when analysing LV remodelling outcomes, ROC curve analysis revealed that low numbers of Tregs (P = 0.017; AUC: 0.69) and increased Th17/Treg ratio (P = 0.012; AUC: 0.70) were predictive of adverse remodelling after TAVI.ConclusionsOur findings demonstrate an association of specific pre-existing inflammatory phenotypes with increased mortality and adverse LV remodelling after TAVI. Distinct monocyte and T-cell signatures might provide additive biomarkers to improve pre-procedural risk stratification in patients referred to TAVI for severe aortic stenosis.
| S-EPMC7524092 | biostudies-literature
Project description: Not available
| S-EPMC8789732 | biostudies-literature
Project description:We present the case of a severely symptomatic patient with a malfunctioning aortic bioprosthesis and severe multidistrict atherosclerosis that was addressed to our unit for transcatheter valve-in-valve implantation. The imaging and clinical assessment that led to the selection of the access route is discussed.
| S-EPMC8564067 | biostudies-literature
Project description:Background: The transfemoral (TF) approach is the most common route in TAVI, but it is still associated with a risk of bleeding and vascular complications. The aim of this study was to compare the clinical outcomes between surgical cut-down (SC) and percutaneous (PC) approach. (2) Methods: Between January 2018 and June 2022, 774 patients underwent a transfemoral TAVI procedure. After propensity matching, 323 patients underwent TAVI in each group. (3) Results: In the matched population, 15 patients (4.6%) in the SC group vs. 34 patients in the PC group (11%) experienced minor vascular complications (p = 0.02), while no difference for major vascular complication (1.5% vs. 1.9%) were reported. The rate of minor bleeding events was higher in the percutaneous group (11% vs. 3.1%, p <.001). The SC group experienced a higher rate of non-vascular-related access complications (minor 8% vs. 1.2%; major 2.2% vs. 1.2%; p < 0.001). (4) Conclusions: SC for TF-TAVI did not alter the mortality rate at 30 days and was associated with reduced minor vascular complication and bleeding. PC showed a lower rate of non-vascular-related access complications and a lower length of stay. The specific approach should be tailored to the patient's clinical characteristics.
| S-EPMC11313030 | biostudies-literature
Project description:The best techniques for reduction of femoral access site complications after transcatheter aortic valve implantation (TAVI) remain the object of research.We report on a single center's experience with TAVI performed via the femoral access site.Between September 2010 and September 2015, 152 consecutive patients underwent TAVI in our department. Of them, 101 patients with CoreValve implantation from the femoral access site were included in the analysis. The femoral artery anatomy-tailored approach was introduced in 2013 in order to reduce the rate of access-site complications. Patients were assigned to percutaneous puncture or surgical cut-down depending on the femoral artery anatomy assessed in computed tomography. The study patients were divided into two subgroups: group A - patients treated before January 2013, before introduction of the tailored approach program (n = 34); and group B - patients treated between January 2013 and April 2015 (n = 67).The access site complication rate significantly decreased from 35.3% in group A (n = 12) to 7.5% in group B (n = 5) (p = 0.0012). Both minor and major access site complications were more frequent in group A (p = 0.04 and 0.016, respectively). In-hospital mortality was 8.8% (n = 3) in group A and 1.5% (n = 1) in group B (p = 0.1).The femoral artery anatomy-tailored approach significantly reduces the incidence of access site complications in TAVI patients.
| S-EPMC5545662 | biostudies-other
Project description: Not available
| S-EPMC10808522 | biostudies-literature