Transcaval transcatheter aortic valve implantation in bicuspid aortic valve: A step-by-step procedural guidance

We report the case of a 78-year-old female with Sapien 3 transcatheter heart valve implantation in the transcaval approach. In this setting, we describe the step-by-step management and technique of the transcaval transcatheter aortic valve implantation. Keywords: bicuspid aortic valve; transcatheter aortic valve implantation (TAVI); transcaval TAV

Balloon-expandable transaortic transcatheter aortic valve implantation with or without predilation

Objective: It has been reported that balloon aortic valvuloplasty immediately before transfemoral or transapical transcatheter aortic valve implantation has mostly little to no clinical value. We aimed to provide data on the need for balloon aortic valvuloplasty in patients undergoing transaortic transcatheter aortic valve implantation. Methods: Patients undergoing transaortic transcatheter aortic valve implantation with the Edwards SAPIEN XT (Nyon, Switzerland) or 3 transcatheter heart valve were prospectively included at 18 sites across Europe. In the present analysis, we compare the periprocedural and 30-day outcomes of patients undergoing conventional (thorn balloon aortic valvuloplasty) versus direct (-balloon aortic valvuloplasty) transaortic transcatheter aortic valve implantation. Results: Of the 300 patients enrolled, 222 underwent conventional and 78 underwent direct transaortic transcatheter aortic valve implantation. Peak and mean transvalvular gradients were improved in both groups with no significant difference between groups. Procedural duration, contrast agent volume, and requirement for postdilation were also comparable. A trend toward fewer periprocedural complications was evident in the direct group (3.9% vs 11.3%; P = .053), with significantly lower rates of permanent pacemaker implantation (0% vs 5.0%; P = .034). Balloon aortic valvuloplasty omission had no significant effect on any of the 30-day safety and efficacy outcomes, including Valve Academic Research Consortium-2 composite end points (early safety events: 22.7% vs 17.4%, odds ratio, 1.17, 95% confidence interval, 0.53-2.62; clinical efficacy events: 20.5% vs 18.7%, odds ratio, 1.14, 95% confidence interval, 0.51-2.55). Conclusions: For many patients, balloon aortic valvuloplasty predilation seems to have little clinical value in transaortic transcatheter aortic valve implantation using a balloon expandable transcatheter valve and may result in a higher rate of periprocedural complications, particularly in terms of permanent pacemaker implantation.Peer reviewe

Bias estimation in study design: a meta-epidemiological analysis of transcatheter versus surgical aortic valve replacement

Background: Paucity of RCTs of non-drug technologies lead to widespread dependence on non-randomized studies. Relationship between nonrandomized study design attributes and biased estimates of treatment effects are poorly understood. Our purpose was to estimate the bias associated with specific nonrandomized study attributes among studies comparing transcatheter aortic valve implantation with surgical aortic valve replacement for the treatment of severe aortic stenosis. Results: We included 6 RCTs and 87 nonrandomized studies. Surgical risk scores were similar for comparison groups in RCTs, but were higher for patients having transcatheter aortic valve implantation in nonrandomized studies. Nonrandomized studies underestimated the benefit of transcatheter aortic valve implantation compared with RCTs. For example, nonrandomized studies without adjustment estimated a higher risk of postoperative mortality for transcatheter aortic valve implantation compared with surgical aortic valve replacement (OR 1.43 [95% CI 1.26 to 1.62]) than high quality RCTs (OR 0.78 [95% CI 0.54 to 1.11). Nonrandomized studies using propensity score matching (OR 1.13 [95% CI 0.85 to 1.52]) and regression modelling (OR 0.68 [95% CI 0.57 to 0.81]) to adjust results estimated treatment effects closer to high quality RCTs. Nonrandomized studies describing losses to follow-up estimated treatment effects that were significantly closer to high quality RCT than nonrandomized studies that did not. Conclusion: Studies with different attributes produce different estimates of treatment effects. Study design attributes related to the completeness of follow-up may explain biased treatment estimates in nonrandomized studies, as in the case of aortic valve replacement where high-risk patients were preferentially selected for the newer (transcatheter) procedure

Transcatheter aortic valve implantation for high-risk patients with severe aortic stenosis: A systematic review

ObjectivesThe present systematic review objectively assessed the safety and clinical effectiveness of transcatheter aortic valve implantation for patients at high surgical risk with severe aortic stenosis.MethodsElectronic searches were performed in 6 databases from January 2000 to March 2009. The end points included feasibility, safety, efficacy, and durability. Clinical effectiveness was synthesized through a narrative review with full tabulation of results of all included studies.ResultsThe current evidence on transcatheter aortic valve implantation for aortic stenosis is limited to short-term observational studies. The overall procedural success rates ranged from 74% to 100%. The incidence of major adverse events included 30-day mortality (0%–25%), major ventricular tachyarrhythmia (0%–4%), myocardial infarction (0%–15%), cardiac tamponade (2%–10%), stroke (0%–10%), conversion to surgery (0%–8%), moderate to major paravalvular leak (4%–35%), vascular complication (8%–17%), valve-in-valve procedure (2%–12%), and aortic dissection/perforation (0%–4%). The overall 30-day major adverse cardiovascular and cerebral events ranged from 3% to 35%. The mean aortic valve area ranged from 0.5 to 0.8 cm2 before and 1.3 to 2.0 cm2 after transcatheter aortic valve implantation. The mean pressure gradient ranged from 34 to 58 mm Hg before and 3 to 12 mm Hg after transcatheter aortic valve implantation. There was no significant deterioration in echocardiography measurements during the assessment period. Death rate at 6 months postprocedure ranged from 18% to 48%. No studies had adequate follow-up to reliably evaluate long-term outcomes.ConclusionsThe procedure has a potential for serious complications. Although short-term efficacy based on echocardiography measurements is good, there is little evidence on long-term outcomes. The use of transcatheter aortic valve implantation should be considered only within the boundaries of clinical trials

Patient-specific image-based computer simulation for theprediction of valve morphology and calcium displacement after TAVI with the Medtronic CoreValve and the Edwards SAPIEN valve

AIMS: Our aim was to validate patient-specific software integrating baseline anatomy and biomechanical properties of both the aortic root and valve for the prediction of valve morphology and aortic leaflet calcium displacement after TAVI. METHODS AND RESULTS: Finite element computer modelling was performed in 39 patients treated with a Medtronic CoreValve System (MCS; n=33) or an Edwards SAPIEN XT (ESV; n=6). Quantitative axial frame morphology at inflow (MCS, ESV) and nadir, coaptation and commissures (MCS) was compared between multislice computed tomography (MSCT) post TAVI and a computer model as well as displacement of the aortic leaflet calcifications, quantified by the distance between the coronary ostium and the closest calcium nodule. Bland-Altman analysis revealed a strong correlation between the observed (MSCT) and predicted frame dimensions, although small differences were detected for, e.g., Dmin at the inflow (mean±SD MSCT vs. MODEL: 21.6±2.4 mm vs. 22.0±2.4 mm; difference±SD: -0.4±1.3 mm, p<0.05) and Dmax (25.6±2.7 mm vs. 26.2±2.7 mm; difference±SD: -0.6±1.0 mm, p<0.01). The observed and predicted calcium displacements were highly correlated for the left and right coronary ostia (R2=0.67 and R2=0.71, respectively p<0.001). CONCLUSIONS: Dedicated software allows accurate prediction of frame morphology and calcium displacement after valve implantation, which may help to improve outcome

Risk factors for paravalvular leak after transcatheter aortic valve replacement

Objective. To assess risk factors for paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI) in a large single-center cohort, including measurement of aortic valve calcification using a reproducible method. Methods. We retrospectively analyzed preoperative contrast-enhanced multidetector computed tomography (MDCT) scans of patients who underwent TAVI in our center between 2009 and 2016. Calcium volume was calculated for each aortic cusp in the aortic valve (AV), left ventricular outflow tract (LVOT) and device-landing zone (DLZ). Results. Overall, 539 patients were included in the study (Edwards SapienXT, n=192; Edwards Sapien3, n=206; Medtronic CoreValve EvolutR, n=44; Symetis Acurate, n=97). Median calcium volume in the DLZ was 757 mm3, with no significant differences among the four prosthesis groups. None of the patients had severe PVL. The overall incidence of mild-to-moderate PVL was 15.8% (95% CI: 12.8-19.1%). On multivariate logistic regression, DLZ calcification (p=0.00006; OR for an increase of 100 mm3 1.08; 95% CI: 1.04-1.13) and use of the CoreValve (p=0.0028; OR 4.1; 95% CI: 1.6-10 with SapienXT as reference) prosthesis were found to be associated with ≥mild PVL. In contrast, degree of oversizing (p=0.002; OR 0.97; 95% CI: 0.95-0.99), and use of Sapien3 (p=0.00005; OR 0.23; 95% CI: 0.11-0.47 with SapienXT as reference) were associated with a lower incidence of ≥mild PVL. Conclusions. Aortic calcification volume in the DLZ is associated with residual PVL after TAVI. When taking calcification into account, the balloon-expandable prosthesis Sapien3 seems to be associated with a lower incidence of PVL

TAVI nel trattamento della stenosi aortica degenerativa: stato dell’arte e prospettive

Degenerative aortic stenosis is the most common form of heart valve disease in developed countries and predominantly affects the elderly. Aortic valve replacement (AVR) has been the gold standard, but recently, transcatheter aortic valve implantation has emerged as an effective therapeutic alternative to conventional AVR for high-risk patients. This review analyzed the literature about AVR, with the objective of evaluating the outcomes of transcatheter aortic valve implantation in patients who are not eligible for surgery showing an improvement in quality of life and middle-term outcomes. The crucial point is the lack of studies with long-term follow-up that could give therapeutic importance to percutaneous valve replacemen

Antithrombotic Therapy After Transcatheter Aortic Valve Implantation

The development of transcatheter aortic valve implantation has represented one of the greatest advances in the cardiology field in recent years and has changed clinical practice for patients with aortic stenosis. Despite the continuous improvement in operators' experience and techniques, and the development of new generation devices, thromboembolic and bleeding complications after transcatheter aortic valve implantation remain frequent, and are a major concern due to their negative impact on prognosis in this vulnerable population. In addition, the optimal antithrombotic regimen in this scenario is not known, and current recommendations are mostly empirical and not evidence based. The present review aims to provide an overview of the current status of knowledge, including relevant on-going randomised trials, on antithrombotic treatment strategies after transcatheter aortic valve implantation

Transcatheter aortic valve implantation in patients with pre-existing chronic kidney disease

AbstractBackgroundWe investigated the effect of chronic kidney disease (CKD) on morbidity and mortality following transcatheter aortic valve implantation (TAVI) including patients on haemodialysis, often excluded from randomised trials.Methods and resultsWe performed a retrospective post hoc analysis of all patients undergoing TAVI at our centre between 2008 and 2012. 118 consecutive patients underwent TAVI; 63 were considered as having (CKD) and 55 not having (No-CKD) significant pre-existing CKD, (defined as estimated glomerular filtration rate (eGFR)<60mL/min/1.73m2). Chronic haemodialysis patients (n=4) were excluded from acute kidney injury (AKI) analysis. Following TAVI, in CKD and No-CKD patients respectively, AKI occurred in 23.7% and 14.5% (p=0.455) and renal replacement therapy (RRT) was necessary in 8.5% and 3.6% (relative risk (RR) [95% CI]=2.33 [0.47–11.5], p=0.440); 30-day mortality rates were 6.3% and 1.8% (p=0.370); and 1-year mortality rates were 17.5% and 18.2% (p=0.919). Patients who developed AKI had a significantly increased risk of 30-day (12.5% vs. 1.1%, p=0.029) mortality. We found the presence of diabetes (odds ratio (OR) [95% CI]=4.58 [1.58–13.3], p=0.005) and elevated baseline serum creatinine (OR [95% CI]=1.02 [1.00–1.03], p=0.026) to independently predict AKI to statistical significance by multivariate analysis.ConclusionTAVI is a safe, acceptable treatment for patients with pre-existing CKD, however caution must be exercised, particularly in patients with pre-existing diabetes mellitus and elevated pre-operative serum creatinine levels as this confers a greater risk of AKI development, which is associated with increased short-term post-operative mortality

Remote Ischemic Preconditioning Neither Improves Survival nor Reduces Myocardial or Kidney Injury in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)

BACKGROUND: Peri-interventional myocardial injury occurs frequently during transcatheter aortic valve implantation (TAVI). We assessed the effect of remote ischemic preconditioning (RIPC) on myocardial injury, acute kidney injury (AKIN) and 6-month mortality in patients undergoing TAVI. METHODS: We performed a prospective single-center controlled trial. Sixty-six patients treated with RIPC prior to TAVI were enrolled in the study and were matched to a control group by propensity-score. RIPC was applied to the upper extremity using a conventional tourniquet. Myocardial injury was assessed using high-sensitive troponin-T (hsTnT), and kidney injury was assessed using serum creatinine levels. Data were compared with the Wilcoxon-Rank and McNemar tests. Mortality was analysed with the log-rank test. RESULTS: TAVI led to a significant rise of hsTnT across all patients (p < 0.001). No significant inter-group difference in maximum troponin release or areas-under-the-curve was detected. Medtronic CoreValve and Edwards Sapien valves showed similar peri-interventional troponin kinetics and patients receiving neither valve did benefit from RIPC. AKIN occurred in one RIPC patient and four non-RIPC patients (p = 0.250). No significant difference in 6-month mortality was observed. No adverse events related to RIPC were recorded. CONCLUSION: Our data do not show a beneficial role of RIPC in TAVI patients for cardio- or renoprotection, or improved survival