TAVI Procedure Research Articles

Vascular complications in TAVI procedures: assessment, management, and outcomes-a retrospective study

ObjectiveTranscatheter Aortic Valve Implantation (TAVI) has emerged as a pivotal therapeutic modality for aortic stenosis, predominantly in the elderly population. Despite its clinical success, the incidence and implications of vascular complications during TAVI remain a subject of critical concern. MethodsA retrospective analysis was conducted on 140 patients who experienced vascular complications during TAVI procedures from a total cohort of 1343 cases. Patient demographics, clinical profiles, and procedural characteristics were scrupulously examined. Vascular complications, both intraoperative and postoperative, were identified through various diagnostic modalities. Statistical analyses were employed to discern associations and significance levels. Comparative assessments with international literature were performed to gain broader insights. ResultsThe study unveiled an overall incidence of vascular complications at approximately 10.44%. Coronary Artery Disease (CAD)-p-value (0.013), choice of valve type-p-value (0.016), and access point-p-value (0.027) demonstrated significant correlations with these complications. Complication incidences in TAVI procedures included pseudoaneurysms (4.76%), arteriovenous fistulas (1.49%), hematomas (0.37%), dissections (2.24%), arterial perforations (0.15%), stenosis/occlusion (0.37%), and closure device failures (1.94%). Over 70% of complications at the valve entry point result from dissections and closure device failures, while the pigtail entry point is predominantly linked to over 70% of pseudoaneurysms. Extended hospitalization (7.84 ± SD 3.14) was observed for patients experiencing vascular complications, underlining the importance of vigilant postprocedural care. ConclusionThis study provides comprehensive insights into vascular complications during TAVI procedures, shedding light on their incidence, risk factors, clinical presentations, diagnostic methodologies, and management strategies.

Feasibility of ultra-low volume contrast pulmonary arterial injection protocol for CTA in TAVI candidates with severe renal failure

Abstract Introduction Computer tomography angiography (CTA) has an important role in patient screening before TAVI. The high volumes of iodinated contrast media (CM) injected during the examination represents the main limitation of CTA with a dose-dependent association with contrast-induced nephropathy. Purpose Show the feasibility of an ultra-low-dose CM pulmonary arterial injection protocol for CTA in TAVI candidates in high risk patients with severe renal failure. Methods In our retrospective study seventy-seven (77) patients with CKD on stage 3b or worse (eGFR ≤ 45/min/1.73 m2) underwent pre-procedural CTA for TAVI-planning with a pulmonary arterial administration of CM. All CTA examinations were performed using a Dual Source 256-slice CT system. All enhanced CT acquisitions were performed using our dedicated biphasic injection protocol composed of two connected phases of contrast medium injection using different amount of CM (8, 10, 15 and 20 ml) according to BMI (<22 kg/m2; 22-24 kg/m2; 24-28 kg/m2; >28 kg/m2). The CM was administered directly into the pulmonary artery in all patients. For each examination was measured Intraluminal attenuation at thoraco-abdominal aorta and along the ilio-femoral vessels using the ROI (mean SD in HU) as objective image parameters (Picture 1). Serum creatinine and the eGFR were recorded pre-TAVI CT scan and after the procedures as reference of CM to renal function. Results CTA was successfully performed in all patients. Mean creatinine was 2.25 ± 0,76 mg/dL and mean GFR was 26.5± 8.1 mL/min/m2. Mean vessel attenuation was 352±164 HU at the aortic annulus, 238.1 ± 141,3 HU in the aortic arch and 266±168 in the iliac arteries (Picture 2). The mean image noise was 28.2 ± 7 HU in the aortic annulus, 24.4 ± 10,9 in the right external iliac artery, and 25. ± 12,8 HU in the left external iliac artery. After CTA examination, a total of 74 patients (96%) underwent TAVI. Mean CM dose administered during TAVI procedure was 150,6 ± 85,8. Three patients (3.9%) were abolished for TAVI. Postprocedural settings complications were recorded. A total of 31 patients (41%) had grade 1 paravalvular regurgitation, 10 patients (14%) grade 2. No cases of valve embolization or anulus rupture occured. No major vascular complications occured. No significant differences between creatine and eGFR pre and post procedures (p<0,001). Conclusions The use of an ultra-low-dose CM pulmonary arterial injection protocol for CTA in TAVI candidates does not affect the renal function and procedural success rate is high and the clinical outcomes after TAVI is satisfactory according to the litterature.

Rupture of the ascending aorta 6 months after TAVI procedure caused by TAVI prosthesis

BackgroundTranscatheter aortic valve implantation (TAVI) is indicated for elderly patients who often have severe comorbidities and high operative risk. Despite many advantages, it carries the potential for both early and late complications. The literature reports mainly periprocedural problems. This case report describes a rare instance of ascending aortic rupture as a late complication following TAVI.Case presentationAn 81-year-old male with severe aortic stenosis (AS) was a non-surgical patient due to a high operative risk (EuroSCORE II 14.08%) and comorbidities, including cardiovascular problems, chronic obstructive pulmonary disease, myelodysplastic syndrome. During the TAVI procedure Medtronic CoreValve™ Evolut™ R-26 was implanted via the right femoral artery. Postoperative period elapsed without complications and the patient was discharged home. Six months later, the patient was re-admitted to the hospital on an emergency basis and transferred directly to the operating room due to ascending aortic rupture (EuroSCORE II 53.20%, GERAADA score 64.9%). Computed tomography angiography (CTA) showed aortic rupture with a multiple fresh blood reservoirs and thrombus around the ascending aorta originating from the spot where the nitinol frame of the TAVI valve was attached to the native aorta. Supracoronary excision of the ascending aorta with implantation of a vascular graft (Intergard Woven Graft 34 mm) was performed, preserving the earlier implanted TAVI valve. On the 9th day after surgery the patient’s general condition deteriorated, he suffered from circulatory and respiratory insufficiency. Furthermore, a gastrointestinal bleeding with the need for gastro-, and colonoscopy and multiple blood transfusions occurred. Patient developed urosepsis and acute renal failure with the need for hemodiafiltration. Despite intensive treatment, further deterioration of the medical condition of the patient. and finally the multiple organ failure was observed. Patient died on the 50th postoperative day.ConclusionsTAVI is a safe method of treating severe AS, especially recommended for non-surgical candidates. Rupture of the ascending aorta is a rare but serious complication of TAVI that usually occur during or shortly after the procedure. This case report highlights the importance of post-procedural monitoring for such TAVI complications, even in the late period following TAVI, and if such complications occur, taking the risk to perform a life-saving operation.

Anesthésie locale comparée à l'anesthésie locorégionale dans les procédures TAVI par voie transfémorale

IntroductionTranscatheter aortic valve implantation (TAVI) has become the treatment of choice for the most fragile patients with severe aortic stenosis. The transfemoral route is preferred as the simplest and safest. The aim of our study was to compare the efficacy, tolerance and safety of local vs. locoregional anesthesia in trans-femoral TAVI procedures. Material and methodThis was a single-center retrospective study. Patients treated with femoral TAVI between February 25 and November 15, 2022 at the University Hospital of Reims were included, and two groups (local and locoregional anesthesia) were compared. ResultsTAVI success rate (92.9%), death rate (3.0%) and procedure duration (90.5 ± 13.5 minutes) did not differ between groups (p = 0.18, 0.15 and 0.55 respectively). For intra- and post-procedural treatments, the use of sedation, analgesics and benzodiazepines did not differ between groups. The cumulative dose of Remifentanil used per-procedure was lower in the local anesthesia group than in the locoregional anesthesia group (148.6 ± 71.9 mcg vs. 208.9 ± 110.0 mcg; p = 0.025). ConclusionsIn this non-randomized retrospective study, local and locoregional anesthesia had comparable safety and efficacy in transfemoral TAVI procedures. In a constrained context and with a view to simplification, these results encourage transfemoral TAVIs to be performed under local anaesthesia, and to consider a “PCI-like” approach, without the presence of an anaesthetist, for selected patients without respiratory, musculoskeletal or agitation disorders, or vascular approach difficulties.

Chronic Right Ventricular Pacing Post-Transcatheter Aortic Valve Replacement Attenuates the Benefit on Left Ventricular Function.

Background: Conduction abnormality post-transcatheter aortic valve implantation (TAVI) remains clinically significant and usually requires chronic pacing. The effect of right ventricular (RV) pacing post-TAVI on clinical outcomes warrants further studies. Methods: We identified 147 consecutive patients who required chronic RV pacing after a successful TAVI procedure and propensity-matched these patients according to the Society of Thoracic Surgeons (STS) risk score to a control group of patients that did not require RV pacing post-TAVI. We evaluated routine echocardiographic measurements and performed offline speckle-tracking strain analysis for the purpose of this study on transthoracic echocardiographic (TTE) images performed at 9 to 18 months post-TAVI. Results: The final study population comprised 294 patients (pacing group n = 147 and non-pacing group n = 147), with a mean age of 81 ± 7 years, 59% male; median follow-up was 354 days. There were more baseline conduction abnormalities in the pacing group compared to the non-pacing group (56.5% vs. 41.5%. p = 0.01). Eighty-eight patients (61.6%) in the pacing group required RV pacing due to atrioventricular (AV) conduction block post-TAVI. The mean RV pacing burden was 44% in the pacing group. Left ventricular ejection fraction (LVEF) was similar at follow-up in the pacing vs. non-pacing groups (57 ± 13.0%, 59 ± 11% p = 0.31); however, LV global longitudinal strain (-12.7 ± 3.5% vs. -18.8 ± 2.7%, p < 0.0001), LV apical strain (-12.9 ± 5.5% vs. 23.2 ± 9.2%, p < 0.0001), and mid-LV strain (-12.7 ± 4.6% vs. -18.7 ± 3.4%, p < 0.0001) were significantly worse in the pacing vs. non-pacing groups. Conclusions: Chronic RV pacing after the TAVI procedure is associated with subclinical LV systolic dysfunction within 1.5 years of follow-up.

SURgical vs. PERcutaneous ACCESS in Transfemoral Transcatheter Aortic Valve Implantation (SU-PER-ACCESS Study).

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.

Ex-vivo Aortic Root Simulator Bench Model for Investigation of Aortic Annular Rupture During TAVI Procedures

Ex-vivo Aortic Root Simulator Bench Model for Investigation of Aortic Annular Rupture During TAVI Procedures

Radiation exposure of patients undergoing transcatheter aortic valve implantation and factors contributing to it

Abstract Background/ Introduction Aortic stenosis (AS) is a calcific disease which affects the aortic valve leaflets and is commonly prevalent in people who are 65 years and older. The global burden of AS is expected to keep on increasing due to the longer life expectancy as well as the morbidity and mortality associated with the disease. Transcatheter aortic valve implantation is utilised for the management of AS. Currently, TAVI is recommended as a first-line treatment for patients who are 75 years and older and those who are at an intermediate to high surgical risk, with the aim of becoming the first treatment option for patients who are 65 years and older. However, one of the concerns of TAVI is the need of ionising radiation during valve placement. The study of exposure to ionising radiation in the TAVI population is becoming progressively more important to consider due to the broader population being considered and the long-term effects related to radiation. Purpose Locally there was no data available covering this topic, thus the aim of the study was to quantify the radiation dose that patients receive during TAVI procedures and to determine any procedural and patient factors that contribute to this radiation dose. Methods Retrospective data analysis was performed for procedures effected between January 2019 and December 2022. All the patients that underwent a transfemoral (TF) TAVI and fit within the inclusion criteria were included in the study. The data was collected from medical databases and underwent a process of data cleaning before information relating to patient and procedural characteristics was extracted. Data about percutaneous coronary interventions (PCI) that were performed during the same time period by the same operators was collected for comparison purposes. Results In total the data of 241 TAVI patients was analysed. Dose Area Product (DAP) was the main radiation metric utilised to quantify the radiation dose. Non-parametric statistical tests were performed due to right-skewedness. The median (IQR) DAP for these procedures was 9000 cGym2 (5975-13150) and the median (IQR) fluoroscopy time was 18.25 minutes (15, 23.5). The years 2019 and 2020 had the lowest median DAP. The DAP obtained in this study is lower than the European DRLs of 13000 cGym2. The median (IQR) DAP (5320cGym2 (2385-9860)), and fluoroscopy time (13.75 mins (8.25-21.62)) for PCIs were lower than for TAVI and this difference is statistically significant (P = &amp;lt;0.001). DAP was not significantly related only to age category and the operator’s combination. Generalised linear models (GLM) showed that prosthetic valve size, body surface area (BSA) and aortic valve gradient are statistically significant predictors of DAP. Conclusion This study shows that the local TAVI patients receive a radiation dose which is within acceptable European limits and that valve size and patient’s BSA are the variables that impacted the radiation dose.

Interventional treatment in elderly patients with severe aortic valve stenosis and coronary artery disease

Aortic stenosis (AS) is a valvular heart disease commonly found in the elderly patients and frequently is associated with coronary artery disease (CAD). The impact of CAD severity and of the percutaneous coronary intervention (PCI) on post-TAVI outcomes is frequently debated. Purpose. Comparison of clinical and hemodynamic outcomes, as well as the rate of major adverse cardiovascular and cerebrovascular events (MACE) in patients undergoing TAVI with PCI (patients with AS and CAD) versus isolated TAVI (patients with AS). Material and methods. Our team conducted a prospective study that included 41 patients, with an age greater than 70 years old, who were diagnosed with severe aortic valve stenosis. After performing coronary angiography, the patients were divided into two groups: 32 patients without significant coronary lesions and 9 patients with multivessel lesions with a Syntax Score &lt;22 and who subsequently underwent coronary angioplasty (PCI). Results. The TAVI procedure was performed with a 100% success rate. After the procedure, the ejection fraction increased inconsiderably in all patients, but the average pressure gradient decreased impressively, the average value being12.59 ± 5.62 mmHg vs 14.78 ± 8.73 mmHg, p&lt; 0.001. The peak velocity of the jet through the aortic valve is 2.36 ± 0.50 m/s vs 2.53 ± 0.83 m/s, p&lt; 0.001.Conclusion. The one-year post-procedural follow-up showed that both groups of patients had a similar rate of MACE, with a significant improvement in clinical-hemodynamic parameters according to transthoracic echocardiography data.

A TAVI VALV IN VALV AT ALMOST 90 YEARS

Abstract Degeneration of the biologic aortic valve prosthesis represents an increasingly important issue. This process often affects frail elderly patients who are not candidates for cardiac re–intervention. TAVI valve–in–valve implantation therefore probably remains the only viable option in such patients.We report the clinical case of Mrs. Luciana F., currently 94 years old, who underwent biological aortic valve replacement in 2016. In charge of the Elderly Patient‘s Heart Failure Outpatient Clinic (SOD Geriatrics–UTIG) since January 2023.At first evaluation,89 years old, widowed, living alone; MMSE 29/30. SPPB 7/12. Totally autonomous in BADL, and partially in IADL.She complained of decreased exercise tolerance (NYHA Class III). No alterations in left ventricular kinetics. Calcified and degenerated aortic valve prosthesis with markedly reduced box opening and severe stenosis (Vel 4.7 m/s; Grad max/med (86/55 mmHg) mild insufficiency. May 2023 access to DEA for syncopal episode, complicated by fall down stairs and head injury; on echocardiogram relief of further degeneration of aortic bioprosthesis (moderate–grade intra–prosthetic insufficiency at 2 jets with PTH 300 msec and severe stenosis, Gmax/Gmed 88/55 mmHg, DVI 0.20 June 2023 worsening of dyspnea that appeared even at rest NYHA IV. At echocolordoppler confirmed severe aortic stenosis severe bioprosthesis degeneration. She was evaluated in Heart Team: low overall risk (MPI 0.31) therefore percutaneous implantation of Medtronic Evolut R aortic bioprosthesis has been performed. At discharge asymptomatic, eupnoic, walking independently without aids for short stretches. At subsequent follow–up.–1 month: substantial clinical well–being in the absence of dyspnea on ordinary exertion (NYHA II), no orthopnea or paroxysmal nocturnal dyspnea; denies angor, heart palp or syncopal episodes. She has resumed household chores and leaves the house almost every day –6 months: clinical stability. She walks long distances every day in the absence of symptomatology. –1 years (turned 90 years old): clinical stability with dyspnea for moderate exertion continues active life. Trans prosthetic gradient max/medium 22/12 mmHg, VD–AD 30 mmHg. In conclusion TAVI procedure on degenerated biological prosthesis should be an option to be considered in the elderly patient selected and evaluated by a multidisciplinary Heart Team to achieve improvement of cardiovascular symptoms and concomitantly recovery of functional autonomy.

DEVELOPMENT OF A HUB–SPOKE NETWORK FOR TRANSCATHTER AORTIC VALVE IMPLANTATION: THE INTERVENTIONAL CARDIOLOGY UNIT OF IRCCS SAN RAFFAELE HOSPITAL (OSR HUB–SPOKE)

Abstract Background The growing prevalence of aortic stenosis determined in recent years an increase in candidates for percutaneous aortic valve replacement (TAVI), bringing out a difficult access to this procedure. In order to reduce waiting lists and to guarantee the training of the Interventional Cardiologists of Centers not equipped with on–site cardiac surgery, we implemented a TAVI protocol with one Hub center, the Interventional Cardiology Unit of IRCCS San Raffaele Scientific Institute, Milan, and two participating Spoke Centers: the ASST–Franciacorta Chiari Center and Valduce Hospital, Como.The aim of this study is to report in hospital outcomes of patients treated using this model of Hub–Spoke Network. Methods Patients included in this model were selected in the Spoke center where baseline clinical evaluation with echocardiography and CT scan were performed (inclusion and exclusion criteria attached). The cases were then discussed with a multidisciplinary team on–line and the procedure planned (access, valve type size). Once the procedure was scheduled, the patients underwent a single day transport to the Hub Center where they underwent TAVI and a same day return to the Spoke Center. A bailout hospitalization in the Hub Center was available in case of major complication. All Spoke Centers patients who underwent TAVI procedures in our Center according to our protocol were included in this analysis. The primary study objective was in hospital major adverse cardiac events (all cause or cardiovascular mortality, stroke, myocardial infarction); secondary study objectives were technical success, prolonged recovery in Hub Center and major vascular complications. Results Since 2019, a total of 69 patients underwent TAVI with the Hub and Spoke model. Mean age was 83 years ± 6 and mean ejection fraction was 59% ± 7%. Two patients (2.9%) had a prolonged hospitalization in the Hub center for a major vascular complication and an intra–procedural cardiac arrest, successfully resuscitated. Technical success was reached in 97.1% of patients. One patient experimented an ischemic stroke after the return in the spoke center: in hospital MACE was than 1.4%. Conclusion Considering the growing prevalence of aortic stenosis, The Hub Spoke Model for TAVI guarantees reduction in waiting lists, "access to care" for patients referred to Spoke centers, involvement and improvement of skills of their Interventional Cardiologists, keeping a high level of safety and efficacy.

Délais d'attente d'implantation de valve aortique transcutanée (TAVI) et mortalité durant la période d'attente en Algérie

BackgroundTrans Aortic Valve Implantation (TAVI) has become the primary treatment for aortic stenosis in patients over 75 years old. Despite its clinical efficacy, it's adoption in emerging countries remains low due to the high cost of prostheses and limited healthcare funding resources. This leads to prolonged waiting times for the TAVI procedure, which may lead to complications; these data are missing particularly in emerging countries. AimsTo describe waiting time for TAVI and mortality rate in this waiting period. Materials and methodsThis was prospective registry, patients referred for TAVI were prospectively followed; waiting time was calculated from the first visit after referral to TAVI implantation, clinical and, call fellow up was performed every 3 months. We divided patients into two groups: Group 1 (G1) patients still awaiting TAVI (105 patients), and those who underwent TAVI (36 patients). Group 2 (G2) patients who died while awaiting TAVI (16 patients, 10,2 %). ResultsDemographic characteristics were similar, with a tendency for older age in G2 (79.5 ± 5.7 years vs. 82.5 ± 7.4 years, p=0,06). G2 exhibited more left ventricular ejection fraction (LVEF) impairment (8.5% vs. 25%, p=0,03) and a higher rate of severe heart failure with dyspnea stages III or IV (2.8% vs. 12.5%, p<0,001). The mean follow-up in G1 was 242.9 ± 137.4 days; the waiting time for TAVI was 231.7 ± 134.1 days, and the average time between the first consultation and death while awaiting TAVI (G2) was 335.1 ± 167.4 days. Conclusionin our series, waiting time is high due to limited Trans aortic heart valve availability, mortality during this wait exceeds 10%. Adverse prognostic factors include impaired LVEF and severe dyspnea stages III or IV.

Impact of aortic root geometry and degree of aortic calcification on outcomes of patients undergoing TAVI procedure.

Adequate differentiation of calcifications in contrast-enhanced CT scans remains difficult to assess TAVI parameters. The size of the aortic leaflets has not been taken into account so far in present studies. The aim of our study was to establish a new method for optimized quantification of the aortic valve calcification degree in contrast-enhanced CT scans for better preoperative prediction of postoperative paravalvular leak after TAVI. We retrospectively analyzed preoperative contrast-enhanced CT scans of patients who underwent TAVI in our institution between 2014 and 2017. Calcium volume was quantified by a method using contrast enhanced computer tomography (3mensio-Structural Heart-7.2 software) with different iodine contents for better discrimination of contrast agent from calcium and by an individually set Houndsfield Unit (HU) threshold with 50HU above the individually determined reference value. Calcium volume was correlated with surface area of each aortic cusp. Perioperative variables were analyzed. All patients (n = 150) with severe aortic stenosis were treated with TAVI implantation. Overall incidence of postoperative trace to moderate PVL was 37%. The amount of calcium correlated with the incidence of PVL. In a logistic regression analysis total volume of calcification (p = .032) as well as calcification of each aortic cusp (NC_p = .001; RC_p < .001; LC_p = .001) were independent predictors. Calcification degree as well as its correlation with the surface area of each aortic cusp significantly influence incidence of PVL. Our new method improves preoperative quantification of the calcification degree by use of contrast agents with different iodine contents and thereby helps to improve patients' outcomes.

APPLICATION OF OBJECT DETECTION TECHNOLOGY IN AORTOGRAPHY KEYPOINT TRACKING

HighlightsThe practical significance of the work lies in the fact that the presented aortography data visualization system is an effective tool for visually assisting surgeons during transcatheter aortic valve implantation interventions, supporting real-time operation mode. The proposed data preprocessing algorithm, which improves image quality with minimal performance costs, complements the system, allowing specialists to achieve the best result. AbstractAim. The aim of this study is to develop a visual assistance system for transcatheter aortic valve implantation procedures.Methods. To address the stated objective, our own dataset consisting of 35 videos of the intervention was used. The visualization system is based on the approach of detecting key points in aortography, utilizing “Object detection” technology with the application of YOLO family artificial neural networks. To achieve the best result, we proposed a method to enhance the quality of input data using convolutional neural networks, specifically the «Autoencoder» technology.Results. The results of the study revealed that the convolutional autoencoder model is capable of restoring the informativeness of noisy input images from 40 to 75%, thereby increasing the accuracy of object detection in images. The presented real-time tracking system for facilitating TAVI procedures achieves a final accuracy of 51.9% according to the Mean Average Precision (MAP) quality metric. The visual assistance system can recognize and track key points indicating the location of the aortic root, delivery system, and heart valve prosthesis during surgery. The practical significance of the work lies in the fact that the presented aortography data visualization system is an effective tool for visually assisting surgeons during interventions, supporting real-time operation mode.Conclusion. The proposed data preprocessing algorithm, which improves image quality with minimal performance costs, complements the visualization system, allowing specialists to achieve the best results.

Immediate results of transcatheter aortic valve implantation.

Aim: To assess, analyze and present early postoperative results of transcatheter aortic valve implantation in patients with aortic stenosis. Materials and Methods: During the period from 2017 to 2023, we examined in total 77 patients with severe aortic stenosis and high risk of surgery who were eligible for the TAVI procedure at the "Heart Institute Ministry of Health of Ukraine". Results: Before implantation, the mean and maximum aortic valve gradients were 53.7±19.1 mm Hg and 90.1±28.8 mm Hg, respectively. The mean and maximum aortic valve gradients after implantation were 9.67±3.18 and 18.7±6.41, respectively (p<0.001). The calculated left ventricular ejection fraction was 57.5±8.22% before surgery and 58.8±7.91% after surgery (p=0.412). After the procedure, moderate (2) degree of paravalvular aortic regurgitation was observed in 2 patients and light degree - in 21 patients. Before surgery, mitral regurgitation of 2-3 degrees was observed in 15 patients, and only in two patients after TAVI The survival rate of our patients was 96.4% after 180 days of supervision. In-hospital and 30-day mortality was 1.8%, while 180-day mortality was 3.6%. No deterioration was observed in patients with moderate aortic regurgitation during echocardiographic studies performed at 1, 3 and 6 months after TAVI. Conclusions: TAVI is rapidly emerging as a life-saving alternative for patients who are inoperable or at high risk of surgery due to comorbidities. The selection of patients for TAVI is important to optimize procedural and long-term outcomes. It is important for cardiologists in our country to refer patients with severe aortic stenosis after diagnosis to centers that perform TAVI.

Transcatheter Aortic Valve Implantation for Bicuspid Aortic Valve Disease: Procedural Planning and Clinical Outcomes.

Bicuspid aortic valve (BAV) is the most common congenital heart disease, with a prevalence of 1-2% and occurring in >20% of octogenarians referred for aortic valve replacement. However, BAV patients have been systematically excluded from pivotal randomized trials. Since TAVI indications are moving toward low-risk patients, an increase in the number of BAV patients who undergo TAVI is expected. BAV represents a challenge due to its unique morphological features (raphe, extreme asymmetrical valve calcifications, cusp asymmetry and aortopathy) and the lack of consensus about the accurate sizing method. The role of multi-slice computed tomography (MSCT) in the planification of the TAVI procedure is well-established, being useful to define the optimal valve sizing and the implantation strategy. New-generation devices, more experience of the operators and better planification of the procedure have been associated with similar clinical outcomes in bicuspid and tricuspid patients undergoing TAVI.

Anticoagulatory treatment and clinical outcomes after transcatheter aortic valve implantation: results from 45,598 patients of the German Aortic Valve Registry (GARY)

Abstract Background Transcatheter aortic valve implantation (TAVI) has developed to the therapy of choice for patients with symptomatic severe aortic stenosis who are inoperable or at high or intermediate operative risk for surgical aortic valve replacement. However, the optimal anticoagulant therapy post-TAVI still remains a matter of debate and individual patient characteristics and comorbidities lead to the prescription of different regimens in clinical practice. Purpose This study investigates current anticoagulant treatment patterns and clinical outcomes in patients after TAVI in a real-world population. Methods The German Aortic Valve Registry (GARY) is a prospective, multicenter all-comers registry enrolling patients undergoing invasive treatment for aortic valve disease. From January 2011 to December 2019, 141,790 patients from 92 hospitals performing TAVI procedures in Germany were enrolled. Different anticoagulant treatment regimens were assessed at hospital discharge for patients after TAVI procedures. All-cause mortality and the combined endpoint "cardiac and cerebrovascular events" containing myocardial infarction (MI), stroke, transient ischaemic attack (TIA), aortic prosthesis re-intervention and all-cause mortality in the first year after TAVI were examined by treatment regimen. Results The study population comprised 45,598 patients with TAVI between 2011 and 2019: 46.5 % received dual antiplatelet therapy (DAPT), 25.7 % oral anticoagulation (OAC) plus antiplatelet therapy, 15.0 % single antiplatelet therapy (SAPT), 6.8 % OAC monotherapy, 4.7 % triple therapy and 1.3 % did not receive any anticoagulant medication. The majority of patients with oral anticoagulation were prescribed VKA (66.8 %) compared to DOAC (33.2 %). After adjustment for baseline confounders, cardiac and cerebrovascular event free survival did not differ significantly between patients with SAPT and DAPT (HR 0.94, 95% CI 0.89-1.00, p = 0.07), albeit the risk of all-cause mortality was slightly increased in SAPT (HR 1.24, 95% CI 1.12-1.37, p &amp;lt;0.001) and all regimens containing oral anticoagulation (OAC mono: HR 1.24, 95% CI 1.08-1.42, p = 0.002, OAC duo: HR 1.23, 95% CI 1.13-1.35, p &amp;lt; 0.001, OAC triple: HR 1.25, 95% CI 1.08-1.45, p = 0.003) compared to dual antiplatelet regime. In patients with OAC, the risk of all-cause mortality (HR 0.99, 95% CI 0.89-1.10, p = 0.81) and cardiac and cerebrovascular event free survival (HR 1.07, 95% CI 0.97-1.18, p = 0.17) was not significantly different in patients with DOAC-containing regimens when compared to VKA-containing regimens. Conclusions In an analysis from one of the world’s largest national registries of patients undergoing TAVI, we found comparative effectiveness of SAPT vs. DAPT and DOACs vs. VKA after TAVI with respect to cardiac and cerebrovascular events. The increased risk of all-cause mortality in patients with antiplatelet monotherapy might be confounded by unmeasured morbidity but requires further attention.Multivariate: Reference group DAPTMultivariate: Reference group VKA

Outcomes in the South African SHARE-TAVI registry: comparison of mortality and risk between treated and untreated cohort, and recent 1-year outcomes in the maturing local TAVR programme

Abstract The South African SHARE TAVI Registry collects local TAVI data to inform health policy, promote access to healthcare, and benchmark the local TAVI programme against recognised best practice. Strong Funder resistance still hampers treatment of aortic stenosis patients after &amp;gt;10 years of TAVI in SA. Method A web-based voluntary all-comers prospective registry captured 2083 patients' clinical history, demographics, TAVI outcomes, complications (VARC 2 definitions) and follow up at 30d, annually post TAVI (8 years). 462 patients assessed for TAVI but not implanted(49 exited prior to funding application, 413 during or after process) were also captured and followed up to 1-year, 413 of these exited during/after the funding application process, 49 exited prior to process (patient declined/unsuitable anatomy). Results Patient populations are similar to other registries and studies using similar generation devices (Schaafsma et al 2022). Outcomes at 30d, 1, 2, and 5 years are comparable to other early TAVI programmes (GARY, Corevalve, PARTNER 1). Average days to Mortality of 813/2545 full patient cohort calculated from date of TAVI Assessment &amp; TAVI procedure date if applicable was highest in implanted patients (693d &amp; 612d) , and lowest in those exiting the programme with no changes to treatment (216d). Most common exit reason was declined funding (71 pts) or death in the funding application process (105pts). Mortality in 68 pts waiting for a response averaged at 93d with STS of 10.996%, and 37 pts with approved funding demised prior to the TAVI date at average 78d in funding process with STS of 9.7%. NON-TAVI patients (n=49) referred for medical or surgical treatment had a longer life expectancy (475 &amp; 366d) than patients who immediately declined implants after the assessment (182d with STS score 7.943). 1year mortality in the 2021 cohort is 14.1%, and in 2022 cohort procedural success is 99.3%, mortality at 30d is 2.53%. Conclusion SA's TAVI programme provides clear benefit to Aortic stenosis patients in terms of life expectancy and the maturing programme's high procedural success and extended life expectancy as shown in local data may be used to support access to treatment in the face of funding resistance.Table 1

NT-pro-BNP pre TAVI and relationship with long-term outcomes

Abstract Background Blood levels of NT-proBNP correlates with aortic valve stenosis and has been suggested as a future target for intervention or selection of patients for aortic valve replacement. Purpose To examine how levels of NT-proBNP pre-TAVI relates to risk of one-year rates of heart failure admission and mortality in patients undergoing TAVI. Methods With Danish nationwide registries, we identified all patients undergoing TAVI from 2014–2021 who had available pre-TAVI NT-pro-BNP measured up to one year prior to TAVI. According to NT-proBNP blood samples, patients were classified according to quartiles of pre-TAVI NT-proBNP levels. The quartiles were then converted into two final groups: Q1-3 including patients with NT-proBNP&amp;lt; 420 pmol/L and Q4 including patients with a NT-proBNP ≥ 420 pmol/L. Groups were compared using cumulative incidence curves of post-TAVI heart failure admissions and Kaplan-Meier estimates to assess comparative all-cause mortality. Adjusted rates of outcomes were assessed, using multivariable Cox analysis, with patients with NT-proBNP&amp;lt; 420 pmol/L serving as reference. Results We identified 1,140 patients undergoing a first-time TAVI procedure (53.1% male, median age 81 year) with an availabel NT-pro-BNP (19.5% of the national chohort of TAVI patients). Of these, 846 (74.21%) patients had a NT-proBNP &amp;lt; 420 pmol/L (55.0% male, median age 81 year) and 294 (25.79%) patients with NT-proBNP ≥ 420 pmol/L (53.1% male, median age 82 year). The one-year cumulative incidence of heart failure was 9.1% and 23.1% for patients with a NT-proBNP &amp;lt;420 pmol/L and ≥ 420 pmol/L, respectively (p&amp;lt;0.001) (Figure 1). This corresponded to an adjusted hazard ratio of 1.91 (95% CI: 1.33–2.74). The one-year cumulative incidence of all-cause mortality was 6.0% and 14.6% for patients with a NT-proBNP &amp;lt;420 pmol/L and ≥ 420 pmol/L, respectively (p&amp;lt;0.001) (Figure 1). This corresponded to an adjusted hazard ratio of 1.85 (95% CI: 1.17-2.92). Conclusion In patients undergoing TAVI, a baseline NT-proBNP ≥ 420 pmol/L was associated with increased one-year rates of heart failure admissions and mortality post-TAVI. The results suggest that NT-proBNP is associated with adverse outcomes on the long-term and that this could be a target for intervention.Figure 1:HF admission and mortality

Acute ischemic stroke complicating tavi. predictors, outcomes, and treatment associated outcomes

Abstract Introduction Despite the great strides made since the emergence of TAVI two decades ago, periprocedural ischemic stroke remains a major concern. The aims of this study were to describe the incidence, characteristic and outcomes of patients presenting with acute ischemic stroke complicating TAVI (AISCT), and to compare conservative therapy vs. neurointervention, in eligible patients. Material and method We analyzed consecutive TAVI procedures performed in our medical center between 2008 and 2021. Patients with and without AISCT were compared. Outcomes of neurointervention to treat AISCT were compared to conservative therapy. Primary outcomes were mortality at 1 and 3 year and neurologic disability status at 3 months. Results and discussion Of 1145 eligible patients who underwent TAVI between 2008-2019, 29 (2.5%) had AISCT within 30 days. All-cause mortality was significantly higher in the AISCT group in 30-days (13.8% vs. 2.9%, p&amp;lt;0.01), 1-year (27.9% vs. 8.1%, p&amp;lt;0.01), and 3-years (50.1% vs. 25.1%, p&amp;lt;0.01), as compared to the AISCT negative group. Lower body mass index (OR- 1.11, 95%CI 1.01-1.21, p=0.03) prior ischemic stroke (OR- 2.80, 95%CI 1.23-6.01, p&amp;lt;0.01) and frailty (OR- 2.98, 95%CI 1.27-6.49, p&amp;lt;0.01) emerged as independent risk factors for stroke. Out of the 38 patients who suffered AISCT between 2008-2021, 7 underwent neurointervention. The majority of AISCT were observed within the first 24-hours following TAVI (p&amp;lt;0.01). All-cause mortality following severe stroke was significantly higher (p&amp;lt;0.01) compare to mild or moderate stroke. There were no significant differences in mortality between the two groups, however, patients with moderate severity stroke (NIHSS score 6-14) undergoing neurointervention enjoyed a higher rate of disability free survival at 3-months compared to patients treated conservatively. (100% compared to 50% respectively, p=NS). Conclusion AISCT was associated with increased morbidity and mortality. Neurointervention, as compared to conservative therapy, may improve disability status in patients with moderate or severe stroke.