Transcatheter Aortic Valve Implantation Procedure Research Articles

Beyond the Obesity Paradox: Analysis of New Prognostic Factors in Transcatheter Aortic Valve Implantation Procedure.

The main purpose of our study was to collect computed tomography (CT) measurements of fat parameters that are significantly related to body mass index (BMI) and evaluate the associations of these measurements and sarcopenia with early and long-term complications after transcatheter aortic valve implantation (TAVI) in order to investigate the existence of the so-called 'obesity paradox' and the role of sarcopenia in this phenomenon. We analyzed the significance of fat CT measurements in 85 patients undergoing the TAVI procedure and compared these with each other, as well as with quantified CT BMI and fat density measurements. Secondly, we evaluated the associations of BMI, CT measurements of fat, and CT evaluations of skeletal muscle mass with early and long-term complications after 24 months of post-TAVI follow-up. We found positive and significant relationships between fat CT measurements with each other and with BMI and a negative and significant relation between fat density and fat quantity. By comparing the CT measurements of fat and skeletal muscle mass with early and long-term complications after TAVI, we confirmed the existence of the 'obesity paradox' and the poor effect of sarcopenia after the TAVI procedure. We confirm that overweight and obesity are good prognostic factors, and sarcopenia is a poor prognostic factor for outcomes following the TAVI procedure. We focused on the scientific validation of an easy and fast way to measure fat and skeletal muscle mass using CT to better predict the outcomes of patients undergoing TAVI.

The development of a Hub & Spoke network for transcatheter aortic valve replacement procedures: the operational model of the Interventional Cardiology Unit at the IRCCS San Raffaele Hospital (OSR Hub-Spoke)

Recently, an increase in the number of patients with severe aortic stenosis eligible for transcatheter aortic valve implantation (TAVI) has been observed worldwide. In order to reduce waiting lists, provide to all patients referred to us equal access to care and to further improve the collaboration with spoke centers, we developed a specific Hub & Spoke specific protocol for TAVI. According to our protocol, a clinical selection (with echo and computed tomography scan) is done by Spoke centers, the case is discussed with a multidisciplinary team online and the procedure is planned (access, valve type size). At day 0, the patient is admitted in Spoke centers where blood samples are taken; at day 1, the patient is transferred to a Hub center for the TAVI procedure and after 2 h of observation, if no adverse events are registered, the patient is transferred back to the Spoke center. Since 2019, an agreement among our center and two hospitals has been signed. According to this Hub & Spoke model, a total of 72 patients with aortic stenosis were treated with TAVI (mean age 83 years, 48.6% female, median Society of Thoracic Surgeons risk 2.4 ± 1.1%, left ventricular ejection fraction 58.0 ± 7.75%). More frequently CoreValve Evolut R (47.2%) was used. Only 2 patients had a prolonged admission at Hub and were not transferred at day 1 (1 vascular complication and 1 intra-procedural resuscitated cardiac arrest). This Hub & Spoke model guaranteed shortening of waiting lists, more effective turnover of bed, equal access to care to patients referred to our center. In addition, it helped also to increase Awareness and education as well as appropriate training of the teams from spoke facilities.

Transcatheter aortic‐valve implantation with or without on‐site cardiac surgery: The TRACS trial

Transcatheter aortic valve implantation (TAVI) has emerged as an effective and safe treatment for patients with symptomatic aortic stenosis. The indication to TAVI should be agreed upon by a Heart Team, and the procedure should be performed in centers with on-site cardiac surgery. However, TAVI complications requiring emergent cardiac surgery (ECS) have become very rare. Concurrently, access disparities and prolonged waiting times are pressing issues due to increasing clinical demand of TAVI. Many solutions have been proposed and one of them is the possibility of performing TAVI in centers without on-site cardiac surgery. The Transcatheter Aortic-Valve Implantation with or without on-site Cardiac Surgery (TRACS) trial is a prospective, randomized, multicenter, open-label study with blinded adjudicated evaluation of outcomes. Patients with symptomatic severe aortic stenosis and deemed inoperable, at high surgical risk, or presenting with at least 1 clinical factor compromising the benefit/risk ratio for ECS, will be randomized to undergo TAVI either in centers with or without on-site cardiac surgery. The primary endpoint will be the composite occurrence of all-cause death, stroke, and hospital readmission for cardiovascular causes at one year. The safety endpoint will include death attributable to periprocedural complications actionable by ECS. The study aims to enroll 566 patients. The TRACS trial aims to address critical gaps in knowledge regarding the safety and efficacy of TAVI procedures performed in centers without on-site cardiac surgery, potentially improving access and outcomes for high-risk patients. ClinicalTrials.gov NCT05751577.

Comparison of patients with occlusive or hemorrhagic access site complications requiring reintervention after percutaneous transfemoral transcatheter aortic valve implantation.

Background: Transcatheter aortic valve implantation (TAVI) via transfemoral (TF) access is increasingly integral to aortic valve disease treatment, expanding beyond high-risk patients. Despite technical advancements, access-related vascular complications, occurring in approximately 10% of TAVI procedures, remain a substantial challenge. Objective: This study investigated the clinical and morphological characteristics of percutaneous TF-TAVI patients experiencing occlusive (OC) and hemorrhagic (HC) complications managed with surgical or endovascular reintervention. Methods: The cohort included patients from a Dutch and a German tertiary referral hospital, managed with TF-TAVI procedures between 2017 and 2021 that required reintervention for OC or HC. Demographics, comorbidities, procedural details, and preoperative imaging data were collected and compared between groups. Results: Among 109 TF-TAVI patients, 32 with OC and 77 with HC required reintervention. The OC group presented significantly smaller access arterial diameters (common femoral artery: OC 6.7 mm vs. HC 8.9 mm, p<.001; external iliac artery: OC 7.2 mm vs. HC 8.3 mm, p<.001; common iliac artery: OC 9.4 mm vs. HC 10.5 mm, p=.012) while the HC group presented higher tortuosity index (TI) (OC 1.24 vs. HC 1.30; p=.017). No differences were observed regarding baseline characteristics, vessel calcification or vascular closure device use. Conclusions: In patients requiring reintervention following TF-TAVI, smaller arterial diameters were associated with OC, while higher TI was linked to HC. These findings emphasize the importance of preoperative imaging in developing individualized prevention strategies.

Real-world evidence of implanting leadless pacemakers after transcatheter aortic valve implantation procedures

Abstract Background Conduction disturbances can be a complication of Transcatheter Aortic Valve Implantation (TAVI) procedures, for which transvenous pacemakers (TVPs) are recommended. Leadless pacemakers (LPs) are a safe alternative to TVPs in a pacemaker-indicated population, but little is known about their use for TAVI-related conduction disturbances. Purpose To examine rates of pacemaker implantation post-TAVI, compare complications, all-cause mortality, and ventricular pacing rates in LP vs. TVP patients, and assess pacemaker deactivations/upgrades in LP patients. Methods Data from Optum’s de-identified Clinformatics Data Mart Database linked to a device registry between 2016 and 2021 were used to identify patients with TAVI procedures that are subsequently implanted with an LP or a TVP. Claims data were used to assess complications and all-cause mortality; device-reported parameters were used to calculate VP rates and deactivations. Complication rates, all-cause mortality, ventricular pacing rates, and device deactivations were calculated for patients with a pacemaker implant between 7 days before and 90 days after TAVI. Chronic complication rates, defined as complications with the potential to occur outside the acute peri- or post-procedural period, were assessed at 1 year. Regressions were used to compare complications and all-cause mortality, adjusting for patient characteristics. Results In a cohort of 18,073 patients with a TAVI procedure, 11.7% were implanted with a pacemaker at 1 year post-TAVI; 76.7% of implants occurred within 7 days. LPs comprised 7.2% of the total pacemaker implants observed. Of those LPs in the registry, around 25% have VDD capability. LP patients were older (avg. 84 LP, 82 TVP, p=0.02) and were more likely to have atrial fibrillation, end-stage or chronic kidney disease, and ventricular arrhythmias. Of patients implanted with a pacemaker within 90 days post-TAVI (LP N=122, TVP N=1,779), there were no differences in 30-day complication rates (12.3% LP, 15.6% TVP, unadj. p=0.33, adj. p=0.27). LP had fewer chronic complications than TVP (0.8% LP, 9.4% TVP, unadj. p=0.02, adj p=0.02) though the sample size was small. LP patients had higher unadjusted 30-day all-cause mortality (4.1% LP, 1.0% TVP, unadj. p=0.01, adj. p=0.06), reflecting the higher acuity of LP patients. At both 30 days and 1 year post-implant, most patients (85.3% LP, 72.7% TVP) continued to receive pacing support (ventricular pacing &amp;gt;10%). TVP patients were more likely than LP patients to be pacing dependent (ventricular pacing ≥90%) at both 30 days (53.8% vs. 29.4%) and 1 year (44.7% vs. 35.7%) post-implant. There were no observed deactivations/upgrades in LP patients at 1 year. Conclusion LPs, when used concomitantly with TAVI procedures, show similar acute and lower chronic complication rates compared to patients treated with TVPs implanted with TAVI. Most patients who received a pacemaker post-TAVI continue to receive pacing support.Acute and Chronic complicationsVentricular pacing

Procedure-related radiation and contrast use during TAVI procedures with balloon-expandable versus self-expanding devices

Abstract Background Transcatheter aortic valve implantation (TAVI) procedures show some fundamental differences, depending on the use of balloon-expandable (BEV) or self-expanding (SEV) devices. We aimed to assess, how it translates into contrast use and radiation exposure. Methods From five high volume European centers consecutive patients were included, who underwent transfemoral TAVI procedure. Patient- and procedural characteristics were recorded and compared in relation to the used TAVI device. Results In total 3131 patients were included. 53% were male and the mean age was 80±9 years. 1273 (41%) patients were treated with BEV, while 1858 (59%) with a SEV system. Patients, receiving SEV were older (81±9 vs 79±9 years, respectively; p&amp;lt;0.01) and were more often females (57% vs 33%, respectively; p&amp;lt;0.01). There was also a trend for less peripheral artery disease (14% vs 17%, respectively; p=0.06). Overall total radiation time was 15±9 min., that was markedly shorter for BEV than for SEV (13±8 vs. 17±10 min., respectively; p&amp;lt;0.01). On average 130±65 mL contrast media was used, that was less for BEV than for SEV (104±52 vs. 148±67 mL, respectively; p&amp;lt;0.01) In terms of contrast use, retrievable- and non-retrievable SEVs were comparable (148±71 vs. 146±63 mL, respectively; p=0.41), but both markedly higher, than for BEVs (p&amp;lt;0.01 for both). Non-retrievable SEVs required less radiation (14±7 vs. 18±10 mins, respectively; p&amp;lt;0.01), but still markedly more than BEVs (p&amp;lt;0.01). Conclusion TAVI procedures with BEV require shorter radiation exposure for the team and markedly less contrast, than with SEV. This might be reasonable to consider during patient-tailored procedure planning.Radiation and contrast usage during TAVI

Multi-modal artificial intelligence-based prediction for cardiovascular mortality after transcatheter aortic valve implantation: a time-to-event survival prediction

Abstract Background Predicting long-term outcomes following Transcatheter Aortic Valve Implantation (TAVI) presents a significant challenge. Objective We aimed to predict post-TAVI long-term cardiovascular mortality using multimodal data and employing time-to-event artificial intelligence (AI) algorithms. Methods This study enrolled 3,973 consecutive patients from the prospective TAVI registry (between August 2007 and June 2023). Multimodal information was collected and extracted as numerical data for each patient, encompassing clinical history, medication, laboratory, procedural characteristics, ECG, angiography, echocardiography (TTE and TEE), and CT. Clinical outcomes were adjudicated by an independent clinical event committee. From the multimodal information, 147 features were extracted at baseline before the TAVI procedure. The datasets were divided into a training/validation set (80%) and a hold-out test set (20%) for model development and evaluation, respectively. Cox-LASSO feature selection was employed to identify the most relevant features, followed by the implementation of Random Survival Forest (RSF), Gradient Boosting Survival Analysis (GBSA), and Survival Support Vector Machine (SSVM) to predict the timing and occurrence of cardiac death events in patients. Feature selection, model parameters, and hyperparameters selection were performed using 10-fold cross-validation on the training set. Model performance was evaluated using different metrics, such as the concordance index (c-index) and cumulative Area Under the Curve (C-AUC) on a 20% untouched test set. Results In the patient cohort, 28.4% experienced cardiovascular death. Features were selected from various modalities, including 22 from clinical history, two from medication, eight from laboratory tests, one from ECG, eight from CT scans, and five from echocardiography and angiography. In the univariate Cox-PH model, all features exhibited a C-index ranging from 0.50 to 0.57. In the test set, the conventional Multivariate Cox-PH model achieves a c-index of 0.59 (C-AUC: 0.56). RSF, GBSA, and SSVM achieve a C-index of 0.70 (C-AUC: 0.69), 0.66 (C-AUC: 0.64), and 0.69 (C-AUC: 0.68), respectively, in the holdout test set. Conclusion Integrating multimodal information, encompassing imaging, signal, laboratory data, and clinical history, with AI algorithms has markedly enhanced the prediction of long-term cardiac outcomes following the TAVI procedure. The initially developed model can predict the probability of cardiac death up to 10 years. Furthermore, the RFS model significantly outperformed the conventional Cox model in predicting time-to-event outcomes.

Independent association between radial secondary access and stroke in patients undergoing transcatheter aortic valve implantation

Abstract Background Radial access has become the primary approach for invasive coronary angiography due to its lower complication rate than femoral access. Transcatheter aortic valve implantation (TAVI) frequently requires a secondary access, which has traditionally been femoral access. However, radial access for TAVI is feasible and gaining popularity, but data on its safety and complication rates is still limited. Purpose To evaluate the occurrence of stroke rate in patients undergoing a TAVI procedure with femoral or radial secondary access. Methods A prospective single-center TAVI registry of 2327 patients who received a TAVI procedure between 2019 and 2022 was conducted. All procedures had the primary access over the femoral route. 337 (14.5%) patients had a secondary access over the radial route, whereas 1990 (85.5%) received a femoral secondary access. The primary endpoint was the occurrence of stroke within the hospital stay. Both groups were compared using the t-test or the Mann-Whitney U test according to the distribution of the data. In a second step, a multivariable model was created in which parameters were included that were associated with the endpoint in the previous analysis, as well as parameters that are known to be associated with stroke. Results: Patients were 81.1 ± 6.3 years old, with a Euroscore II of 5.3 ± 6. A total of 610 (26.2%) patients received a balloon-expandable valve. The primary endpoint (stroke within 30 days of the TAVI procedure) was met by 94 (4%) of all patients. Stroke occurred more often in the group with radial secondary access (6.6% (22) vs. 3.6%(72), p = 0.012). Other significant differences between the two groups included (radial vs. femoral access): burden of atrial fibrillation (36.8% vs. 44.6%, p = 0.007), arterial hypertension (87.4% vs. 92%, p = 0.007), Euroscore II (4.6 vs. 5.5, p = 0.006), and frailty (25.2% vs. 40%, p &amp;lt; 0.001). There were no significant differences between the two groups in terms of secondary diagnosis of diabetes or coronary artery disease, age, occurrence of NYHA class III/IV, gender, or cerebral artery disease. In the multivariate analysis including Age, Euroscore II, NYHA class, gender, secondary diagnosis of arterial Hypertension, diabetes or cerebral artery disease, arterial fibrillation, Frailty and radial secondary access, only radial secondary access was independently associated with in-hospital stroke (p = 0.01). Conclusion Radial secondary access was significantly associated with an increased risk of in-hospital stroke following transcatheter aortic valve implantation (TAVI) in our study population. Intense manipulation of the guidewire and catheter to reach the ascending aorta at the beginning of the procedure and to reach the descending aorta for the final angiogram of the primary access vessel may be causative and should be minimized.

Procedural and clinical outcomes according to ultrasound-guided access in TAVI: a propensity-matched comparative sub-analysis from the PULSE registry

Abstract Background Access-related vascular and bleeding complications during transcatheter aortic valve implantation (TAVI) are associated with significant morbidity and mortality. Ultrasound-guided (USG) puncture may reduce the incidence of these events, particularly in large-bore arterial access. However, large-scale data on this approach are limited and it has not yet fully been implemented into standard clinical practice during TAVI. Purpose We compared access-related vascular and bleeding complications in USG versus fluoroscopy-guided (FG) access from a large multicenter TAVI registry. Methods The PULSE registry (Plug or sUture based vascuLar cloSurE after TAVI) retrospectively evaluated data of 9,295 patients who underwent transfemoral TAVI at 10 high-volume German heart centers from 2016 to 2021. USG and FG access were performed in 1,992 (21.4%) and 7,303 (78.6%) patients, respectively. A propensity score was used to match 1,023 FG with 1,023 USG access patients in a 1:1 fashion. The primary endpoint was a composite of minor and major vascular complications at the TAVI-access site or bleeding type II-IV. Outcomes were evaluated in accordance with the Valve Academic Research Consortium (VARC-3) definitions. Results Mean age was 81.9±6.25 years and 48.0% of patients were female. Comorbidities and clinical variables were well-balanced in matched groups. The overall risk profile was comparable in USG vs. FG (mean EuroSCORE II: 3.4 [2.1, 6.4] vs. 3.6 [2.2, 5.7], p=0.54). The primary end point occurred in 12.0% in the USG and 17.7% in the FG group, p&amp;lt;0.001. While major large bore access-related vascular complications did not differ significantly (3.5% vs. 4.2%, p=0.49), there was a trend towards lower minor complications for USG compared to FG (5.9% vs. 7.8%, p=0.096). Large bore access-related bleeding occurred in 5.5% versus 7.8% (p=0.04) of patients. Endovascular balloon inflation was required in 0.6% and 3.3% (p&amp;lt;0.001) of all large-bore access vascular complications. Stroke (1.7% vs. 1.5%, p=0.86) and stage III/IV acute kidney injury (3.0% vs. 2.2%, p=0.42) were similar in both groups. Conclusion In patients treated with transfemoral TAVI, ultrasound-guidance for gaining access was associated with lower rates of access-related vascular complications or type II-IV bleeding. Endovascular treatment was required more frequently in case of a fluoroscopy-guided approach. These findings challenge the fact that most TAVI procedures were performed with fluoroscopy-guidance.

Delivering shared decision-making before transcatheter aortic valve implantation using digital and remote techniques to enhance patient engagement and convenience

Abstract Introduction Transcatheter aortic valve implantation (TAVI) is an alternative to surgical aortic valve replacement for patients with aortic stenosis. However, the choice between TAVI, surgery, wait and watch or conservative management needs to be based upon multiple factors including comorbidity, life expectancy, anatomy, local experience and, critically, informed patient preference. In this context, engaging patients in a shared decision-making (SDM) process becomes essential, but this practice is generally underused. Purpose To comply with both international guidance and the National Institute for Health and Care Excellence (NICE) UK recommendations, in January 2023 we established a formal SDM pathway for TAVI, utilising digital solutions as much as possible to minimise the logistic impact for both hospital and patients. We aimed to quantitatively measure the compliance of the digital SDM meeting from the patients’ perspective with the NICE recommended essential and enhanced discussion standards. Methods Patients are contacted when the multidisciplinary heart team recommends TAVI, then offered digital or, where appropriate, physical patient decision aids and a link to a TAVI-specific explanatory video. One week later, patients are invited to a virtual comprehensive SDM meeting where a specialist nurse discusses aortic stenosis and treatment options with the patient as per the NICE recommended standards, allowing time for questioning and review. From December 2022 to June 2023, a custom developed questionnaire was administered to 20 patients prior to, and 28 patients after the implementation of the SDM meeting protocol, directly addressing the patients’ perception of adherence to the NICE standards. This was provided to the patients after the TAVI procedure via an online tool. The answers to the 12 core questions were converted into a Likert scale (1 to 5) and the global satisfaction scores for the 2 patient groups, reported as the average Likert score across the 12 questions, were compared with the Wilcoxon Rank-Sum Test. Results The global satisfaction score was significantly higher for the post-SDM group than for the pre-SDM group (mean 4.27 vs 3.55, p&amp;lt;0.001). The percentage of patients who gave positive (Likert 4-5) responses to each individual question was consistently higher in the post-SDM group. The percentage of patients giving negative (Likert 1-2) responses was substantially lower in the post-SDM group. Conclusions The SDM pathway and the virtual tools provided proved effective in delivering SDM in compliance with international guidance and NICE recommended standards from the patient’s perspective. A similar approach leveraging digital technology to minimise cost and enhance patient convenience could be implemented for other treatments and across other institutions.Questionnaire results

Temporal trends of aortic valve replacement modalities by age group in the United-States 2015 - 2023

Abstract Background/Introduction Transcatheter aortic valve implantation (TAVI) has led to a paradigm shift in treating aortic stenosis (AS) across patients of all surgical-risk categories. To guide the clinical decision, the ACC/AHA guidelines recommended an age group classification; with SAVR being recommended in patients &amp;lt; 65 years, and TAVI being favored over SAVR in patients &amp;gt; 80 years. In patients between 65-80 years, both modalities are to be considered after shared decision making. The impact of those guidelines-derived age group classification on the contemporary AVR practice remains of interest and is dynamically changing. Purpose This study aims to examine the temporal trends in the modality of AVR (TAVI vs SAVR) in the U.S. among different age groups using a contemporary nationwide database. Methods We conducted a retrospective study using de-identified data from the Vizient Clinical Database, which gathers patient and hospital data from more than 1000 medical Centre. We analysed TAVI and SAVR procedures from October 1, 2015, to November 30, 2023, excluding patients under 18. We examined the national trends of TAVI vs SAVR in 3 age groups (&amp;lt;65, 65-80, &amp;gt;80 years) with AS. Trend analysis was performed using linear regression. This study was deemed exempt from the requirements of 45 CFR 46.104(d) by The Miriam Hospital Institutional Review Board given that it involved de-identified data. Results During the study period, 467,832 underwent AVR (TAVI n= 252,834, SAVR n= 214,998). The patient and hospital characteristics by age group are summarized in the Table. We observed a significant rise in TAVI adoption from 33.5% in 2015 to 59.96% in 2023. However, the pattern of temporal trends varied among different age groups. In patients &amp;gt; 80 years, TAVI showed a steep rise from 69.95% in 2015 to 92.96% in 2023 (p&amp;lt;0.002). The 65-80 years age cohort demonstrated the most pronounced growth in TAVI, rising from 26.23% in 2015 to about 60% in 2020 (p.001), after which a plateau in percentage was observed. TAVI in patients &amp;lt;65 years has also been increasingly adopted, rising from 7.18% in 2015 to 19.12% in 2020 (p&amp;lt;0.002), however, followed with a slight downtrend to 16.36% in 2023 (Figure). Conclusion In this most contemporary analysis from the U.S., we demonstrate an increase in the adoption of TAVI across all age groups over the study period, with the steepest rise observed in patients between 65-80 years of age. Since the 2020 ACC/AHA guidelines, there has been a gradual downtrend in the utilisation of TAVI in patients &amp;lt;65 years of age indicating a possible change in practice based on scientific societal recommendations. The stabilization in TAVI percentage in the age groups 65-80 years and &amp;gt; 80 years in the last few years may hint towards approaching equilibrium between TAVI and SAVR for these age groups.Proportions of AVR across age groups

Early echocardiographic changes and reverse remodeling after transcatheter aortic valve implantation

Abstract Introduction Our hospital is a tertiary centre performing more than 500 transcatheter aortic valve implantation (TAVI) procedures annually. In this study we present early echocardiographic changes post-TAVI. Methods Clinical data collection and comprehensive echocardiography was performed the day before and 3.5±1.6 months after TAVI. Data analysis compared pre- and post-TAVI evaluations. Results A total of 101 patients were analyzed. Mean age was 80.1±6.8 years and 40% were female. TAVI was performed transfemorally in all patients, with 83% receiving a balloon expandable valve. NYHA class improved from 2.5±0.6 to 1.4±0.5 after TAVI (p&amp;lt;0.001) Echocardiographic parameters are summarized in Table. Global longitudinal strain (GLS) improved from -17±4% pre-TAVI to -18±4% post-TAVI (p&amp;lt;0.001), with no notable change in LVEF. A significant reverse remodeling with ≥10% reduction in left ventricular mass index (LVMi) was observed in 52% of patients following TAVI (from 124±32 to 110±29 g/m2, p&amp;lt;0.001) (Figure). Predictors of LVMi reduction were pre-TAVI LVMi and absence of comorbid hypertension (OR=1.02, 95% CI=1-1.03, p=0.03 and OR=0.31, 95% CI=0.11-0.84, p=0.02 respectively). There was no significant improvement in diastolic function, including left atrial strain. Conclusions Early post-TAVI assessments showed significant reverse remodelling with improvements in GLS and LVMi after TAVI. Predictors of LVMi reduction post-TAVI were absence of comorbid hypertension and higher baseline LVMi. There was no notable changes in diastolic function.

Prospective evaluation of transcatheter aortic valve implantation (TAVI) with coronary alignment and impact on coronary access

Abstract Introduction Transcatheter aortic valve implantation (TAVI) with optimised coronary alignment aims to reduce coronary-commissural overlap (CCO) to facilitate future coronary intervention and reduce the risk of coronary obstruction after re-do TAVI, however, in-vivo data are lacking. Aims To determine the feasibility of TAVI with coronary alignment assessed by post-TAVI CT. Secondary endpoints included the incidence of adverse anatomical features which could impede coronary access (severe CCO and ostia below valve skirt) and their association with coronary engagement during invasive angiography. Methods 30 patients underwent TAVI with optimised coronary alignment with either ACURATE neo2 or Evolut Pro+ and invasive coronary angiography and cardiac CT performed after valve deployment. Results 15 patients received ACURATE neo2 (50%) and 26 patients (86.7%) underwent CT after TAVI. The mean inter-coronary angle was 140 (19.5)° and the median observed angular deviation from perfect alignment (0°) was 0.8° (IQR -4.5 to +10) ° with perfect alignment (±15°) observed in 21/26 cases (80.8%) and ≤mild misalignment (±30°) in 24/26 of cases (92.3%). The remaining two cases had moderate misalignment (30-45°) with no cases of severe misalignment. The angle between the coronary ostia and the nearest TAVI commissure was 46 (40 - 57) ° for the RCA and 50.5 (43 - 54) ° for the LCA which did not differ significantly from the native situation (both p&amp;gt;0.2), with 1 (3.8%) case of severe overlap. 46/55 (83.6%) coronary engagements were selective, 7/55 (12.7%) semi-selective and 2/55 (3.6%) unable to intubate. Non-selective engagement/unable to engage affected the RCA more than the LCA (6/27 [22.2%] vs. 3/28 [10.7%]) and was three-fold more common with the Evolut (7/29 [24.1%]) than the Acurate (2/26 [7.7%]. Coronary&amp;gt;commissural angle in those with unselective engagement was 43° (IQR 37 to 51°). Conclusions TAVI with optimised coronary alignment is technically feasible, safe and reduces coronary-commissural overlap which is important for future re-do TAVI procedures. Difficult coronary access was encountered more frequently following Evolut Pro+ and when engaging the RCA, but was unrelated to angular distance to nearest commissure.

Echocardiographic and clinical features of patients developing prosthesis-patient mismatch after TAVI: insights from an international multicenter registry

Abstract Background The impact of prosthesis-patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) is controversial. Purpose Our study aims to evaluate the impact of PPM on mortality and clinical-echocardiographic progression of cardiac damage in a "real world" cohort of patients at intermediate and low surgical risk and to characterize its main predictors. Methods 963 patients who underwent TAVI procedure between 2017 and 2021, from an international multicenter observational registry, were included in this analysis. Multiparametric echocardiographic data were analyzed at 1-year follow-up (FU). Clinical and echocardiographic features were stratified by presence of PPM and PPM severity, as per the most current international recommendations (VARC-3 criteria). Results 18% of patients developed post-TAVI PPM, (7.7% of the whole cohort severe). At baseline, 50.3% of patients with PPM were male (vs 46.2% in the cohort without PPM, p=0.33), aged 82y (interquartile range (IQR) 79-85y) vs 82y (IQR 78-86y; p=0.46), and 55.6% had Balloon-Expandable valves implanted (vs 46.8% of patients without PPM, p=0.04); they had smaller left ventricular outflow tract (LVOT) diameter (20mm, IQR 19-21 vs 20mm, IQR 20-22, p=0.02), reduced Stroke Volume index (SVi) (34.2 vs 38 ml/m2, p&amp;lt;0.01) and transaortic flow rate (190.6 vs 211 ml/s, p&amp;lt;0.01). At pre-discharge FU patients with PPM had more paravalvular aortic regurgitation (AR) (moderate/severe AR 15.8% vs 9.2%, p&amp;lt;0.01). At a median FU of 1.46 years (IQR 1-4), there was no evidence of a significant impact of PPM on overall mortality (15.3% vs 13.1%, p=0.46) nor on rehospitalization rate for heart failure (4.3% vs 8.0%, p=0.10). At 1-year FU, maladaptive alterations of left ventricular parameters were found in patients with PPM, with a significant increase in endsystolic diameter (ESD) (33 vs 28mm, p=0.03) and a statistically non-significant increase in LV mass index (121 vs 106g/m2, p=0.07). Interestingly, trajectory parameters of patients with PPM from baseline to 1-year FU showed a reduced cardiac remodeling compared to patients without PPM, including no LVEF improvement (p=0.88), absent reduction of LV end-diastolic volume (p=0.70), indexed LV mass (p=0.31), ESD (p=0.48) and pulmonary artery systolic pressure (p=0.82), and an increase of basal RV diameter (p&amp;lt;0.001). Patients with moderate/severe PPM had worse NYHA functional class at 1 year (NYHA III-IV 13% vs 7.8%, p=0.03). Independent predictor of PPM at multivariable logistic regression was male gender (OR=1.93, p=0.04); while SVi (OR=0.86, p&amp;lt;0.001), prosthetic size &amp;gt;23mm (OR=0.62, p=0.03) and LVOT diameter (OR=0.79, p=0.02) had protective effect. Conclusions There was no evidence of a short- or medium-term impact of PPM on mortality. However, clinical-echocardiographic evaluations demonstrated a PPM-related pattern of early ventricular maladaptive alterations associated with a significant deterioration in NYHA class at 1 year.

Sizing of the aortic valve using virtual reality - next step towards personalized medicine?

Abstract Background High-quality imaging is integral throughout the transcatheter aortic valve implantation (TAVI) process, from patient selection and preprocedural planning to real-time guidance during the procedure and postprocedural follow-up. Multislice computed tomography (MSCT) is currently the gold standard. The next step in this area is the three-dimensional (3D) visualization of cardiac and extra-cardiac structures using virtual reality (VR). Purpose This study aimed to investigate the feasibility, accuracy, and reproducibility of VR for the visualization of the aortic valve, the surrounding structures, and its role in the planning of TAVI procedures. Methods Based on the preprocedural MSCT data of 60 patients who underwent TAVI at our heart center, measurements using 3mensio software were compared with 3D visualizations and measurements using VR software. Additionally, eight physicians evaluated the application of VR using a structured questionnaire to define its benefits and limitations. Results VR measurements correlated well with the 3mensio software measurements, and there were no significant differences between the two methods. The VR measurements were mentioned first: Annulus perimeter 77.4 ± 7.8 vs. 77.0 ± 8.1 (p=0.182), r = 0.929; Annulus diameter 24.6 ± 3.2 vs. 24.4 ± 2.6 (p=0.483), r = 0.868; LVOT diameter 23.5 ± 3.1 vs. 23.7 ± 2.8 (p=0.442), r = 0.785; SoV left 32.9 ± 4.1 vs. 32.7 ± 3.7 (p=0.331), r = 0.920; SoV right 30.8 ± 4.3 vs. 30.7 ± 3.7 (p=0.653), r = 0.909; noncoronary SoV 32.9 ± 3.6 vs. 32.6 ± 3.7 (p=0.209), r = 0.913; STJ 30.0 ± 3.6 vs. 29.7 ± 3.2 (p=0.175), rs = 0.882; Ascending aorta 34.5 ± 3.4 vs. 34.5 ± 3.1 (p=0.469), r = 0.921, RCA height 15.1 ± 3.2 vs. 15.4 ± 3.2 (p=0.179), rs = 0.910, LCA height 12.4 ± 2.7 vs. 12.3 ± 3.0 (p=0.252), rs = 0.924. Furthermore, users reported that VR simplified anatomical understanding (1.3 ± 0.5 vs. 1.9 ± 0.4, p = 0.046), and improved 3D comprehension (1.1 ± 0.4 vs. 2.3 ± 0.5, p = 0.023). Conclusion The use of VR in the planning of TAVI procedures enables precise and reproducible measurements. In addition, VR can help assess the often complex anatomy, which can increase the safety and efficiency of procedures. Further clinical studies are needed to evaluate the potential benefits of VR application in planning and performing other structural interventions.

HV interval measure immediately before TAVI with SEV for predicting pacemaker implantation

Abstract Introduction Although improvements, new onset persistent disturbances in electrocardiogram (ECG) after transcatheter aortic valve implantation (TAVI) remains up to 34% at hospital discharge (1), needing permanent pacemaker implantation (PPM) in self-expanding valves (SEV) as high as 15-27% (2,3). In post TAVI scenario, European Society of Cardiology guidelines recommend an electrophyisiologic study centered in His-ventricular electrogram (HV) interval measure for assessing risk of progression to high auriculoventricular block (AVB), if abnormal a PPM is indicated (4,5). We aim to predict PPM through basal HV interval measurement prior TAVI with SEV. Furthermore, we aim to compare different current SEV with basal HV interval and the distinct rate of PPM before discharge. Methods and Results Single-center prospective cohort study, patients with severe aortic stenosis scheduled for TAVI, sinus rhythm at intervention day, without PPM or history of PPM indication were included. At time of TAVI, contralateral venous puncture to femoral arterial access was made, a tetrapolar catheter was advanced and placed at the septal aspect of tricuspid valve searching for His electrogram. A mobile polygraph was used to measure ECG parameters and HV interval before TAVI. Then, a tetrapolar catheter was advanced to ventricle to perform rapid stimulation as part of habitual valve implantation protocol. After procedure, we performed rhythm surveillance for at least &amp;gt;48-72 hours and based in electrical evolution one of three decisions was made: 1)PPM implant, 2)late post TAVI HV interval re-measure or 3)clinical daily ECG vigilance, if this last was normal, unchanged from basal or with new but stable conduction disturbances, discharge were indicated following ESC guidelines. A total of 41 patients were enrolled, median age 84±4 years, 24 females (54.5%), PR mean 198±42ms, QRS mean 112±30ms. 18 had a 1st degree AVB (40.9%) of whom 13 (72.5%) had a PR ˂240ms. EPS data showed prior HV interval mean of 55±9ms. A Mild abnormal HV interval (56-69ms) were seen in 21 patients (51.2%), of whom 12 had a narrow QRS. SEV implanted were 11 (25%) Medtronic CoreValve Evolut+, 5 (11.4%) Biosensors Allegra, 25 (56.8%) Abbott Navitor. Post TAVI procedure, 5 (12.2%) women and 8 (19.5%) men met criteria for PPM implantation before discharge. One woman was implanted 6 days after discharge due to high AVB (66ms HV interval prior TAVR). In a multivariate analysis including sex, age, PR, QRS and HV interval &amp;gt;55ms, valve type the RR (IC 95% 1.37-30.99) risk of PPM was 6.52 folds higher (p=0.019). Conclusions An HV interval &amp;gt;55ms before TAVI with SEV increases risk of PPM after TAVI and before hospital discharge. There was no difference in PPM implantation after TAVI between different SEV types in our center.

Higher product of right ventricle to left ventricle diameter ratio and septal wall thickness is associated with increased risk of cardiovascular death in patients post TAVI

Abstract Background Right ventricular (RV) dilatation is a significant predictor for mortality in various cardiovascular diseases. Hypertrophy is common in patients undergoing transcatheter aortic valve implantation (TAVI). We tested the hypothesis that the product of right ventricle to left ventricle diameter (RV/LV) ratio and septal wall thickness (SWT) might be a determinant of cardiovascular death in TAVI patients. Methods This retrospective study enrolled 1123 patients undergoing TAVI in our department between 2009 and 2021 (mean age 81.4±5.6 year, male 51.2%). We assessed standard echocardiographic measures prior to the TAVI procedure. End-diastolic basal biventricular dimensions were measured from a standard apical 4-chamber view, and the ratio of RV dimension (RVD) to LV dimension (LVD) was calculated as the RV/LV ratio. We tested the prognostic performance of the product of RV/LV ratio and septal wall thickness (RV/LV ratio*SWT). The primary endpoint was cardiovascular (CV) death up to 2 years after TAVI. Results CV mortality was 11.8% (132/1123) at 2 years after TAVI. SWT was similar between the groups with and without CV death (11.9±1.9 vs. 11.6±1.8 mm, P=0.188). However, the RV/LV ratio (0.84±0.15 vs. 0.80±0.13, P=0.002) and RV/LV ratio*SWT (10.0±2.7 vs. 9.3±3.1 mm, P=0.005) were notably higher in the CV-death group compared to the no CV-death group. Higher RV/LV ratio*SWT remained independently associated with elevated 2-year CV mortality after TAVI (HR=1.09, 95% CI 1.01-1.17, P=0.024), while the RV/LV ratio was no longer significantly linked with CV mortality (HR=2.83, 95% CI 0.87-9.19, P=0.082) after adjusting for potential confounding factors including age, sex, and atrial fibrillation. RV/LV ratio*SWT &amp;gt;12.7 mm was associated with a twofold increased risk of 2-year CV mortality compared to patients with RV/LV ratio*SWT ≤12.7 mm (2-year mortality 14.4% vs. 6.0%, P&amp;lt;0.001; HR=2.04, 95% CI 1.25-3.32, P=0.004), regardless of age, sex, and atrial fibrillation. Conclusions Combined assessment of biventricular remodelling and left ventricular hypertrophy by calculating RV/LV ratio*SWT is of clinical importance for risk stratification of cardiovascular death among TAVI patients.

Simultaneous versus staged approach in transcatheter aortic valve implantation for severe stenosis and endovascular aortic repair for thoracic and abdominal aortic aneurysm.

Thoracic/abdominal aortic aneurysms and aortic stenosis may be concomitant diseases requiring both transcatheter aortic valve implantation (TAVI) and endovascular aneurysm repair (T/EVAR) in high-risk patients for surgical approaches, but temporal management is not clearly defined yet. The aim of the study was to analyse outcomes of simultaneous versus staged TAVI and T/EVAR. Retrospective observational multicentre study was performed on patients requiring TAVI and T/EVAR from 2016 to 2022. Patients were divided into 2 groups: 'Simultaneous group' if T/EVAR + TAVI were performed in the same procedure and 'Staged group' if T/EVAR and TAVI were performed in 2 steps, but within 3 months. Primary outcomes were technical success, 30-day mortality/major adverse events and follow-up survival. Secondary outcomes were procedural metrics and length of stay. Forty-four cases were collected; 8 (18%) had T/EVAR and 36 (82%) had EVAR, respectively. Upon temporal determination, 25 (57%) and 19 (43%) were clustered in Simultaneous and Staged groups, respectively. In Staged group, median time between procedures was 72 (interquartile range-IQR: 57-87) days. Preoperative and intraoperative figures were similar. There was no difference in 30-day mortality (Simultaneous: 0/25 versus Staged: 1/19; P = 0.43). Pulmonary events (Simultaneous: 0/25 versus Staged: 5/19; P = 0.01) and need of postoperative cardiac pacemaker (Simultaneous: 2/25 versus Staged: 7/19; P = 0.02) were more frequent in Staged patients. The overall length of stay was lower in the Simultaneous group [Simultaneous: 7 (IQR: 6-8) versus Staged: 19 (IQR: 15-23) days; P = 0.001]. The median follow-up was 25 (IQR: 8-42) months and estimated 3-year survival was 73% with no difference between groups (Simultaneous: 82% versus Staged: 74%; P = 0.90). Both Simultaneous or Staged T/EVAR and TAVI procedures are effective with satisfactory outcomes. Despite the small numbers, simultaneous repair seems to reduce length of stay and pulmonary complications, maintaining similar follow-up survival.

Anaesthetic and Procedural-Related Complications in Transcatheter Aortic Valve Implantation (TAVI) and Its Outcome: A Retrospective Observational Study.

Background Transcatheter aortic valve implantation (TAVI) presents significant challenges in its management, not only due to the technical complexity of the procedure but also because it is primarily performed on elderly patients who often have multiple comorbidities, making perioperative care and post-procedural recovery more intricate and demanding. The study's objective is to discover the challenges faced during the TAVI procedure and the frequency of complications that occurred during and after the procedure. Methods This is a single-centre retrospective study. Patients with symptomatic severe aortic stenosis, considered at high risk for conventional surgical aortic valve replacement, were included, their medical records were extracted, and data were collected. Endpoints at one-year follow-up comprised one-year mortality, cause of death, and valve dysfunction. Procedural-related complications were also noted as procedural-related outcomes. Results The mean age and body mass index (BMI) of the patients were 73.9 years and 28.3 kg/m2, respectively. The main comorbidities were hypertension (n = 33, 84.6%), diabetes mellites (n = 21, 53.8%), ischemic heart disease (n = 6, 15.38%), and chronic obstructive pulmonary disease (COPD) (n = 5, 12.8%). The mean European System for Cardiac Operative Risk Evaluation (EuroSCORE) was 5.75% with a median of 2.38%. General anaesthesia was received (n = 27), whereas the rest of the cases were performed under monitored anaesthesia care (MAC). None of the patients developed surgical site hematoma or massive blood loss. Post-operative mechanical ventilation was required in three patients (10.2%), and two (5.12%) of them expired in the intensive care unit. One patient had on-table mortality. Conclusion A low rate of anaesthesia and procedural-related complications was observed. The TAVI procedures done in our centre are promising and parallel to the finest global centres' outcomes in terms of procedural triumph and complication rate.

Early outcomes with a fully retrievable SinoCrown transcatheter heart valve in patients with severe aortic stenosis.

This study summarizes and analyzes data from patients suffering from symptomatic aortic stenosis who successfully underwent transcatheter aortic valve implantation (TAVI) using a novel, completely retrievable transcatheter heart valve. We included patients who underwent a TAVI procedure with SinoCrown valves at our center between December 2021 and September 2022. We collected 1-year follow-up data on survival, complications, echocardiographic results, New York Heart Association functional class in heart failure, and patient-reported health-related quality of life outcomes. Eight successive patients (73.3 ± 4.3 years) were included in the study, with a median Society of Thoracic Surgery risk score of 4.26%. The procedure had a 100% success rate. Median postoperative discharge time was 7 days, with no 30-day hospital readmissions. Postoperative aortic valve hemodynamics improved, indicated by decreased transvalvular flow velocity compared with preoperative values (1.9 ± 0.2 vs. 4.9 ± 0.2 m/s, p < 0.0001). The median and maximum follow-up times were 8 and 12 months, respectively. During the follow-up period, there were no serious complications such as death, stroke, valve embolization, or high-grade atrioventricular block. The results from eight initial TAVI cases performed with the SinoCrown valve demonstrated promising safety and efficacy.