TAVI Procedure Research Articles

Balloon-expandable transfemoral transcatheter aortic valve implantation with or without predilation: findings from the prospective EASE-IT TF multicentre registry

BackgroundPredilation of the native valve has long been deemed necessary in transfemoral transcatheter aortic valve implantation (TF-TAVI), despite little trial evidence to support its clinical use. As most evidence is...

Safety and efficacy of hybrid vascular closure technique using both a suture- and collagen-mediated closure device after transfemoral transcatheter aortic valve implantation.

To evaluate the clinical utility and feasibility of a hybrid technique for obtaining vascular hemostasis by combining a suture- and a collagen-mediated system after transfemoral transcatheter aortic valve implantation (TF TAVI) in a real-world setting. In 75 consecutive TF TAVI procedures, we investigated a hybrid closing method to achieve hemostasis at the large bore puncture site using a combination of one presuture closure system (ProGlide) and one collagen-mediated system (Angio-Seal). Vascular complications at puncture site were recorded until discharge. Successful hemostasis by the hybrid technique was achieved in 74 out of 75 patients, and the method was well tolerated by all patients. In 73 patients, (97.3%) neither puncture site related complications nor serious early or late bleedings were observed during a median hospital stay of 2 days postprocedure. This single-center registry study indicates that a percutaneous hybrid closure technique is safe and efficacious in closing large bore arteriotomies. It is an easy and reliable technique that may contribute to simplifying TAVI procedures. The data was collected from an internal quality control registry on treatment of patients with valvular heart disease with or without coronary artery disease, No 2014/17280, Oslo University Hospital, Ullevål.

A Novel Treatment for a Han Patient with High Risk of Coronary Obstruction Underwent TAVI Procedure using a Novel Second-Generation Device

A Novel Treatment for a Han Patient with High Risk of Coronary Obstruction Underwent TAVI Procedure using a Novel Second-Generation Device

Comparison of Carbon Dioxide Flush and Saline Flush to Saline Flush Alone in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia

Comparison of Carbon Dioxide Flush and Saline Flush to Saline Flush Alone in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia

Hypnosis Versus SIVOC by Remifentanil During TAVI Procedures : Iloact on Peripoperative Confusion

Hypnosis Versus SIVOC by Remifentanil During TAVI Procedures : Iloact on Peripoperative Confusion

Quantitative aortography for assessing aortic regurgitation after transcatheter aortic valve implantation: results of the multicentre ASSESS-REGURGE Registry.

Quantitative aortography using videodensitometry is a valuable tool for quantifying paravalvular regurgitation after TAVI, especially in the minimalist approach - without general anaesthesia. However, retrospective assessment of aortograms showed moderate feasibility of assessment. We sought to determine the prospective feasibility of quantitative aortography after a protocol of acquisition. This was a multicentre registry in Japan, Canada, the Netherlands and Germany including consecutive patients with Heart Team indication to undergo TAVI over a median period of 12 months. Operators performed final aortograms according to a pre-planned projection (either by CT or visually - Teng's rule). An independent core laboratory (Cardialysis) analysed all images for feasibility and for regurgitation assessment. From the four centres included in the present analysis, a total of 354 patients underwent TAVI following the acquisition protocol and all the aortograms were analysed by the core lab. The analyses were feasible in 95.5% (95% confidence interval [CI]: 93.2% to 97.5%) of the cases. This rate of analysable assessment was significantly higher than the feasibility in previous validation studies, such as in the RESPOND population (95.5% vs. 57.5%, p<0.0001). No differences were observed among different planning strategies (CT 96.5% vs. Teng's rule 93%, p=0.159; or Circle 98.5% vs. 3mensio 95.8% vs. Teng's rule 93%, p=0.247). ASSESS-REGURGE showed a high feasibility of assessment of regurgitation with quantitative aortography with protocoled acquisition. This may be of great importance for quantifying regurgitation in TAVI procedures (optimisation, guidance of post-dilatation), and in future clinical trials, in order to address sealing features of novel devices for TAVI objectively. ClinicalTrials.gov Identifier: NCT03644784.

Impact of Transcatheter Aortic Valve Implantation on Symptoms and Quality of Life in Australian Patients: Insights from the ACOR TAVI Registry

Objective: To evaluate the health status outcomes of TAVI patients using two standardised and validated patient-reported outcome measures (PROMs). Methods: From April to October 2018, TAVI Registry patients were requested via phone, email, mail or direct contact to complete the PROMs at two timepoints: pre-procedure (416 patients) and 30-day follow-up (273 eligible patients). The PROMs include: a generic quality of life questionnaire, the EQ-5D and a disease specific instrument, the Kansas City Cardiomyopathy Questionnaire (KCCQ). Results: The cohort mean age was 83 years (range 59-87) and 57% male. For both PROMs there was a high completion rate: the pre-procedure timepoint (KCCQ n = 384 (92%), EQ5D n = 390 (94%)) was lower than at 30-days (KCCQ n = 262 (96%) EQ5D n = 264 (97%)). The mean KCCQ-overall score increased from 49.7 ± 22.7 pre-procedure to 76.0 ± 21.2 at 30-days (p value < 0.0001). All KCCQ domains increased when comparing pre-procedure and 30-day follow-up. The overall mean EQ5D visual analogue scale (score 0-100) increased from 59.8 ± 18.9 to 72.9 ± 17.0 at 30-days (p value < 0.001). A comparison of pre-procedure and 30-day follow-up data using EQ5D showed a significant increase in all five domains. Conclusion: A dramatic improvement at 30-days is being reported by patients supporting the clinical benefits of the TAVI procedure. This significance was demonstrated throughout all domain variables and as an overall score in both PROMs. As the TAVI Registry reaches its 1-year timepoint, it is expected the outcomes will continue to improve which aligns with the PROMs data reported from other international registries.

Outcomes of transcatheter aortic valve replacement according to femoral or non-femoral peripheral vascular access site: A propensity-matched comparison from the French TAVI Registry

Femoral access is currently the preferred approach for TAVI procedures. However, it is not feasible in all cases and alternative access sites, peripheral and transthoracic have emerged. To compare femoral to non-femoral peripheral vascular access site in propensity matched group. Using data from the national prospective French registry in France – the France TAVI registry – we compared the characteristics and outcomes of TAVI procedures according to whether they were performed through a femoral or a non-femoral peripheral (transcarotid or transaxillary), with a propensity score-based matching of patients with femoral and non-femoral peripheral interventions. Among 13.157 patients included in the France TAVI registry, 83.9% underwent a femoral TAVI, 6.7% a non-femoral peripheral vascular TAVI, and 9.4% transthoracic TAVI. Patients in non-femoral peripheral access were more severe (mean logistic Euroscore 17.3 vs. 19.7, P < 0.001), with a higher rate of peripheral vascular disease, known coronary artery disease, chronic pulmonary disease and renal failure. After matching, there was no difference in the rate of complications according to access site, except for a twice-lower rate of vascular-access related complications in the non-femoral peripheral vascular approach (OR 0.56 (0.32–0.96), P = 0.03 after adjustment to the prosthesis type). There was no difference in short or long term mortality rates. Compared to femoral approach, non-femoral peripheral TAVI is associated with a similar outcome except for a twice-lower rate to access site-related complications. It should be considered more routinely as an alternative to femoral approach.

Role of Multidetector Computed Tomography in Transcatheter Aortic Valve Implantation – from Pre-procedural Planning to Detection of Post-procedural Complications

Abstract Transcatheter aortic valve implantation (TAVI) is an effective treatment option for patients suffering from symptomatic, severe aortic valve stenosis. Previously, only patients with prohibitive or high surgical risk were TAVI candidates; however, current guidelines already recommend TAVI as a treatment alternative for patients with intermediate surgical risk. Multidetector computed tomography (MDCT) has gained great importance in the periprocedural assessment of patients who undergo TAVI. Due to the three-dimensional image visualization, MDCT allows the evaluation of anatomical structures in a more comprehensive manner compared to echocardiography, the traditional tool used in TAVI patient work-up. By providing accurate measurements of the aortic root, MDCT helps to avoid potential patient-prosthesis mismatch throughout transcatheter valve sizing. Moreover, MDCT is also a feasible tool for access route evaluation and to determine the optimal projection angles for the TAVI procedure. Although the routine MDCT follow-up of patients is currently not recommended in clinical practice, if performed, it could provide invaluable information about valve integrity and asymptomatic leaflet thrombosis. Post-procedural MDCT can provide details about the position of the prosthesis and complications such as leaflet-thrombosis, aortic regurgitation, coronary occlusion, and other vascular complications that can represent major cardiac emergencies. The aim of the current review is to overview the role of MDCT in the pre- and post-procedural assessment of TAVI patients. In the first part, the article presents the role of pre-TAVI imaging in the complex anatomical assessment of the aortic valve and the selection of the most appropriate device. The second part of the review describes the role of MDCT in patients who underwent TAVI to assess potential complications, some of them leading to a major cardiovascular emergency.

RF09 BEST OF BOTH WORLDS: DIRECT-VISION BALLON-EXPANDABLE TRANSCATETHER PROSTHESIS WITH EXCISION OF ANTERIOR MITRAL LEAFLET TO TREAT SEVERE STENOSIS IN BIG MITRAL ANNULAR CALCIFICATION PATIENTS

Background and aim: The mitral annular calcification (MAC) is one of the most demanding and exciting challenges for the cardiac surgeon. Numerous surgical techniques to approach MAC have been described, and many include decalcification and annular reconstruction. The aim of this study is to describe an alternative method of treatment of the MAC, performing surgical implant of a prosthesis designed for the percutaneous implant in aortic position under direct vision and to define the applicability criteria. Methods: Preoperative evaluation is a key point to define the possible treatment options of the MAC. The CT-scan is the fundamental tool that allows quantification of calcium and its possible extension in the underlying myocardium. An indispensable criterion is that the calcification interests the annulus in an almost completely circumferential manner, in such a way as to allow a safe deployment prosthesis. Results: We report a surgical approach to manage MAC and avoid calcium debridement by using a prosthesis designed for TAVI procedures. The anulus is measured with an Egar dilator and part of the anterior mitral leaflet is removed which creates room for a bigger implant. An Edwards SAPIEN 3 Transcatheter Heart Valve is implanted in the mitral annulus under direct vision and then the crimped valve is deployed with a manual inflation device. Inflation of the ventricle with saline allows to identify any valvular leaks and correct them by placement of one or more stitches. Conclusions: This technique seems a safe and effective solution for treating the MAC in selected cases.

Prospective registry on cerebral oximetry-guided transcarotid TAVI in patients with moderate-high risk aortic stenosis.

The aim of the study was to assess safety TAVI procedure through the common carotid artery in high-vascular-risk patients. The approach was selected by a multidisciplinary (cardiologists and cardiac surgeons) heart team after analyzing preoperative coronary angiography, transthoracic echocardiography and multislice contrast computed tomography of the peripheral arteries. Patients with the following conditions were qualified to the transcarotid access: severe peripheral artery disease (stenotic, heavily calcified), tortuous or small diameter <6 mm iliofemoral arteries, descending and abdominal aortic disease. Ten transcarotid transcatheter aortic valve implantation procedures were performed in our hospital from September 2017 to May 2018. There were no in-hospital deaths or strokes. The procedural success rate defined as the implantation of the valve with no coronary obstruction and less than moderate paravalvular leak was 100%. Parameters of regional cerebral oximetry were symmetrical on the left and right side in all cases and only during rapid ventricular pacing transiently decreased below the value of 50%. Postoperative cerebrovascular complications and myocardial infarctions were not observed. Statistically significant reduction of the echocardiographic parameters (PGmax and PGmean, Vmax) were observed. Mild paravalvular leaks occurred in 4 patients. Additionally, the heart failure symptoms diminished after the procedure from a median class III to class II. In the 3-month follow-up, mortality is 10% (unknown cause of death of one patient). The mean NYHA class of the other patients is II. Echocardiographic parameters are comparable to postoperative day 4. The pilot registry showed the safety of transcarotid approach in patients with the anatomy precluding the transfemoral approach.

TCT-446 Feasibility study of a single synchronized diastolic injection with low contrast volume for aortography in a progressive aortic regurgitation porcine model.

With the evolution of TAVI procedures and the rise of a minimalistic approach, aortography (re)emerges as a crucial tool for aortic regurgitation (AR) assessment. However, TAVI candidates often have reduced renal function and are therefore more vulnerable to contrast induced nephropathy, thus

P6224Hemodynamics of the left coronary artery after TAVI procedure: a numerical simulation analysis

P6224Hemodynamics of the left coronary artery after TAVI procedure: a numerical simulation analysis

P2653Determination of the new risk factors for predicting long term mortality in patients undergoing transfemoral tavi procedure: can the conventional risk scores be used as a long term mortality predictor

P2653Determination of the new risk factors for predicting long term mortality in patients undergoing transfemoral tavi procedure: can the conventional risk scores be used as a long term mortality predictor

P03-6 - Anaesthetic management and perioperative outcomes in patients undergoing a TAVI procedure

P03-6 - Anaesthetic management and perioperative outcomes in patients undergoing a TAVI procedure

TAVI transaxilar: la técnica paso a paso

The rise of TAVI procedures has motivate the search of the best vascular access. In this article, we explain the transaxillary access step by step. A safe and easy access, that is giving similar result to transfemoral. In this article we try to solve doubts and create a guide that helps in the procedure.

Improved Registration of 3D CT Angiography with X-ray Fluoroscopy for Image Fusion During Transcatheter Aortic Valve Implantation

The fusion of 3D anatomical models derived from high-fidelity pre-interventional computed tomography angiography (CTA), and x-ray (XR) fluoroscopy to facilitate anatomical guidance is of huge interest for complex cardiac interventions like TAVI procedures with cerebral protection. Co-registration of CTA and XR has been introduced either based on additional intraoperative non-/contrast-enhanced cone-beam computed tomography (CBCT) or two separate aortograms. With the related increase of radiation exposure and/or contrast agent (CA) dose, a potential additional risk for the patient is introduced. Here, we propose a modified co-registration approach making use of arteriograms of the iliofemoral arteries, routinely performed during the femoral puncture and sheath introduction. On-the-fly refinement of the co-registration during the on-going procedure enables accurate co-registration without any additional angiograms, thus reducing CA, XR dose and procedure time, while simultaneously improving operator confidence and procedure safety.

Incidence, Predictive Factors, and Prognostic Impact of Silent Atrial Fibrillation After Transcatheter Aortic Valve Implantation

New onset atrial fibrillation post-transcatheter aortic valve implantation (TAVI) is common and is associated with adverse outcomes. However, silent atrial fibrillation (AF) is poorly documented in the context. This study sought to evaluate the incidence, predictive factors, and prognostic value of Silent AF post-TAVI. All the consecutive patients with TAVI were prospectively analyzed by continuous electrocardiogram monitoring≥48 hours after implantation. Silent AF was defined as asymptomatic episodes lasting at least 30 seconds. The population was divided into 3 groups: history of AF, no-AF, and silent AF. Among the 206 patients implanted with TAVI, 19 (16.1%) developed silent AF. Compared with the no-AF group, patients with silent AF shared the same clinical characteristics and cardiovascular risk factors. Procedural success and echography parameters after the device implantation were similar between groups. Left atrial volume was significantly increased (p <0.001) in the silent AF group, together with preimplantation C-reactive protein (CRP) >3 mg/L and glucose (p = 0.048 and p = 0.002). By multivariate analysis, CRP >3 mg/dl and logistic European System for Cardiac Operative Risk Evaluation were identified as independent predictors of silent AF. In-hospital and 1-year mortalities were higher in pre-existing AF patients, whereas no-AF and the silent AF patients share the same prognosis. Our prospective study showed for the first time that silent AF is frequent after TAVI procedures. In conclusion, our work suggests that CRP could help to predict the risk of developing silent AF. However, the onset of silent AF is not associated with worse prognosis in the year following the procedure in our study.

Impact of "high" implantation on functionality of self-expandable bioprosthesis during the short- and long-term outcome of patients who undergo transcatheter aortic valve implantation: Is high implantation beneficial?

High position of the self-expandable bioprosthesis CoreValve/Evolut R has been proved to affect immediate hemodynamics of the valve. Whether this may have any impact on long-term procedural outcome has not been defined yet. The purpose of this study was to assess whether the final position of aortic bioprosthesis affects its long-term functionality. Consecutive patients (pts) who underwent successful TAVI procedure were evaluated and separated into 2 groups according to the implantation depth (ID): Group I: pts with 4mm <ID ≤13mm; Group II: pts with ID ≤4mm. ID was measured utilizing the final aortography after device delivery and was defined as the distance both from the native non- and left coronary cusp to the deepest edge of the deployed bioprosthesis in the left ventricle. Clinical outcome and echocardiographic parameters were recorded before the procedure, at discharge, at 1-month and 1-year-follow-up. One hundred and ninety-eight pts (80±5.5years, 107 males [54%]) treated with the CoreValve/Evolut R bioprostheses were recorded. Group I appeared to have higher peak gradient (17±6.5 vs 14±5.5mmHg, P=.02) as well as Vmax (2±0.4 vs 1.84±0.38m/s, P=.02) at follow-up after 1year when compared with Group II (ID <4mm). Grouping for ID did not affect all-cause 1-year mortality. Paravalvular aortic regurgitation, as well as LVEF at discharge, proved to be independent predictors of all-cause 1-year mortality when adjusted for cofactors. Implantation depth under 4mm seems to have a favorable effect on long-term hemodynamic valve functionality.

Complications after transcatheter aortic valve implantation using transfemoral and transapical approach in general anaesthesia.

BackgroundTranscatheter aortic valve implantation (TAVI) is a minimally invasive procedure used to treat degenerative heart valve disease. The implantation requires a highly specific and interdisciplinary management approach. Currently, TAVI is performed with the patient under local or general anaesthesia.MethodsThis study was a retrospective analysis of all TAVI procedures performed at the University Hospital of Regensburg between January 2009 and July 2015. All pre-, intra and postoperative data focusing on perioperative complications were recorded.ResultsA total of 853 transfemoral- and transapical-TAVI patients were included in the study. All patients underwent general anaesthesia. The ASA classifications were primarily 3–4. The average logistic EuroScores for the transfemoral- and transapical-TAVI patients were 18 ± 12% and 21 ± 15% (p = 0.002), respectively. The anaesthesia coverage time was 170 ± 49 min., including 37 ± 12 minutes for anaesthetic management. Overall, 458 complications were recorded; with pneumonia, acute renal failure, indication for a permanent pacemaker and non-extubation in the operating theatre the most frequently recorded complications.ConclusionIn the present study, we showed that our patients’ outcomes are comparable to those reported in the available literature. Compared to TF, TA patients show an overall worse physical condition as well as a higher perioperative morbidity and mortality. Consequently TA patients need additional care and should only be operated in appropriately experienced medical centres.