Transcatheter Aortic Valve Implantation Procedure Research Articles

Temporal Trends in Transcatheter Aortic Valve Implantation: 10-Year Analysis of the TAVIDOR Registry.

Transcatheter aortic valve implantation (TAVI) has established itself as the preferential strategy to approach severe aortic stenosis. Information on procedural improvements and nationwide results obtained with the technique throughout the past decade are unknown. To assess the temporal variation of the demographic profile, procedural characteristics, and in-hospital outcomes of patients undergoing TAVI procedures at the Rede D'Or São Luiz. Observational registry comprising 29 national institutions, comparing the characteristics of the TAVI procedures performed from 2012 to 2017 (Group 1) to those performed from 2018 to 2023 (Group 2). The statistical significance level adopted was p < 0.05. This study assessed 661 patients, 95 in Group 1 and 566 in Group 2, with a mean age of 81.1 years. Group 1 patients had a higher prevalence of New York Heart Association functional class III or IV and STS risk score > 8%. In addition, they more often underwent general anesthesia, transesophageal echocardiographic monitoring, and access through femoral dissection. Group 2 patients had a higher success rate of the TAVI procedure (95.4% versus 89.5%; p = 0.018), lower mortality (3.9% versus 11.6%; p = 0.004), and less often needed permanent pacemaker implantation (8.5% versus 17.9%; p = 0.008). The 10-year temporal trends analysis of the TAVIDOR Registry shows a reduction in patients' clinical complexity over time. Furthermore, the advance to minimalistic implantation techniques, added to the technological evolution of the devices, may have contributed to the favorable outcomes observed among those whose implantation occurred in the last 5 years studied.

Successful Repositioning of Left Ventricular Wire after Advancing Delivery System in a Transapical Transcatheter Aortic Valve Implantation Procedure: A Case Report

Successful Repositioning of Left Ventricular Wire after Advancing Delivery System in a Transapical Transcatheter Aortic Valve Implantation Procedure: A Case Report

Geographical Inequality in Access to Aortic Valve Intervention in England: A Report from the UK Transcatheter Aortic Valve Implantation Registry and National Adult Cardiac Surgery Audit.

For patients with severe aortic stenosis, transcatheter aortic valve implantation (TAVI) is a less invasive but equally effective treatment option compared with surgical aortic valve replacement (SAVR). In 2019, we reported low rates of TAVI in the UK compared with other countries in western Europe and highlighted profound geographical variation in TAVI care. Here, we provide contemporary data on access to aortic valve replacement by either TAVI or SAVR across clinical commissioning groups in England. We obtained aggregated data from the UK TAVI registry and the National Adult Cardiac Surgery Audit between 2019 and 2023. Rates of TAVI and SAVR procedures per million population were reported by clinical commissioning groups. The relationship between TAVI and SAVR rates was determined using Pearson correlation coefficients. In 2022/23, the rates of TAVI and SAVR in England were 136 per million population and 60 per million population, respectively. The observed increase in TAVI rates since 2019/20 corresponded with a decline in SAVR rates. There remains substantial variation in access to both procedures, with an over tenfold variation in TAVI rates, and an over fourfold variation in SAVR rates across clinical commissioning groups in England. No relationship was identified between the rates of TAVI and those for SAVR (correlation coefficient 0.06). Geographical heterogeneity in access to TAVI persists over time, with the low rates of TAVI in many areas not compensated for by higher rates of SAVR, indicating an overall inequality in the treatment of severe aortic stenosis.

Our Experience in Transcatheter Aortic Valve Implantation (TAVI) from the Anesthesiologist's Perspective: A Single-Center Retrospective Study

Objectives This study is aimed to review the perioperative complications, morbidity, and mortality rates of patients undergoing TAVI at our tertiary care hospital. Material and Methods The data for this retrospective study including 34 patients was collected from medical records of the patients. Statistical analyses were performed using SPSS 26 programme. The results were considered statistically significant at p&lt;0.05. Results The study cohort, predominantly the elderly population (mean age 77.3 years), underwent TAVI under local anesthesia and sedation. Anesthetic induction involved fentanyl, ketamine and midazolam, with adjustments using propofol as needed. Hypotension emerged as the most common anesthesia-related complication. Importantly, the procedure was completed with conscious sedation in all cases that are not complicated by surgery, with no instances of respiratory complications. The most frequent procedure-related complication was atrioventricular bundle branch block. Postoperative outcomes demonstrated a significant reduction in aortic valve parameters, validating the efficacy of the procedure. Notably, the 30- and 90-day mortality rates were 0%, indicating favorable short-term survival. The study highlighted the importance of maintaining hemodynamic stability through vasopressors, with noradrenaline being the preferred choice. While the overall length of hospital stay averaged six days, the study emphasized the evolving landscape of TAVI, with shorter hospitalizations attributed to increasing procedural experience and refined anesthetic approaches. The need for permanent pacemaker was observed in 20% of cases. Conclusion This comprehensive analysis contributes valuable insights into the evolving field of TAVI, emphasizing the role of experienced anesthesiologists in optimizing patient outcomes. The study underscores the importance of refining anesthesia protocols, staying abreast of emerging guidelines and developing solution algorithms for emergency scenarios, ultimately enhancing the safety and efficacy of TAVI procedures in a rapidly expanding patient population.

Preoperative computed tomography-imaging with patient-specific computer simulation in transcatheter aortic valve implantation: Design and rationale of the GUIDE-TAVI trial

Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe aortic valve stenosis, but is still associated with relatively high rates of pacemaker implantation and paravalvular regurgitation. Routine preoperative computed tomography (CT) combined with patient-specific computer modelling can predict the interaction between the TAVI device and the patient's unique anatomy, allowing physicians to assess the risk for paravalvular regurgitation and conduction disorders in advance to the procedure. The aim of this trial is to assess potential improvement in the procedural outcome of TAVI by applying CT-based patient-specific computer simulations in patients with suitable anatomy for TAVI. The GUIDE-TAVI trial is an international multicenter randomized controlled trial including patients accepted for TAVI by the Heart Team. Patients enrolled in the study will be randomized into 2 arms of each 227 patients. In patients randomized to the use of FEops HEARTGuide (FHG), patient-specific computer simulation with FHG is performed in addition to routine preoperative CT imaging and results of the FHG are available to the operator(s) prior to the scheduled intervention. In patients randomized to no use of FHG, only routine preoperative CT imaging is performed. The primary objective is to evaluate whether the use of FHG will reduce the incidence of mild to severe PVR, according to the Valve Academic Research Consortium 3. Secondary endpoints include the incidence of new conduction disorders requiring permanent pacemaker implantation, the difference between preoperative and final selected valve size, the difference between target and final implantation depth, change of preoperative decision, failure to implant valve, early safety composite endpoint and quality of life. The GUIDE-TAVI trial is the first multicenter randomized controlled trial to evaluate the value of 3-dimensional computer simulations in addition to standard preprocedural planning in TAVI procedures.

Outcomes of Transcatheter Aortic Valve Implantation under Transfemoral Approach Versus Alternative Approach in King Chulalongkorn Memorial Hospital

Background: The transfemoral approach (TF) is the access of choice for transcatheter aortic valve implantation (TAVI). However, approximately 10% of patients have anatomy or comorbidity unsuitable for TF. Objective: To analyze the outcomes of an alternative approach compared with TF in the authors’ institute. Materials and Methods: A retrospective analysis of patients undergoing TAVI in King Chulalongkorn Memorial Hospital between December 2010 and 2021 was conducted. The present study compared the baseline characteristics, outcomes, and complications of TAVI procedures, including one-year mortality, according to whether they were performed through a TF or alternative approach. Results: Among 210 patients that underwent TAVI, 188 (89.6%) were in the TF group and 22 (10.4%) were in the alternative group with seven in the trans-subclavian, nine in the transapical, and six in the transaortic. The mean age of the population was 81 years. Patients in the alternative group had more severe disease (median logistic EuroSCORE-II 19.67 versus 10.01, p&lt;0.001). Other baseline characteristics were not different between groups. According to the Valve Academic Research Consortium 3 (VARC-3) criteria, there were higher mortality and complication rates in the alternative group but no statistical differences regarding 30-day mortality of TF at 2.1% versus alternative at 9.1% (p=0.121) and 1-year mortality of TF at 5.3% versus alternative at 13.6% (p=0.143). Hospitalization times were significantly longer in the alternative group (median hospital stay in days of TF 4 versus alternative 10, p=0.013). Although no statistical significance was found, there were trends towards a higher rate of valve malpoition for TF at 3.7% versus alternative at 13.6%, and major vascular complications for TF at 1.6% versus alternative at 9.1%. Conclusion: The authors’ institute data demonstrates alternative approach TAVI was associated with a similar mortality rate and post-procedural complication rate compared with transfemoral TAVI, except for a trend toward a higher rate of valve malposition and major vascular complications. The alternative approach TAVI may be favored in patients with high or prohibitive surgical risk unsuitable for transfemoral TAVI. Keywords: Transcatheter aortic valve implantation; TAVI; Alternative approach; Transfemoral; Operative outcomes

The feasibility of relaxation-enhanced angiography without contrast and triggering for preprocedural planning of transcatheter aortic valve implantation.

Cardiovascular MRI is advantageous in transcatheter aortic valve implantation (TAVI) planning. This study aimed to evaluate the feasibility of comprehensive non-contrast MRI [relaxation-enhanced angiography without contrast and triggering (REACT)] combined with a three-dimensional whole-heart MRI protocol for preprocedural planning of TAVI vs. computed tomography angiography (CTA). Thirty patients with severe aortic stenosis were prospectively enrolled. The anatomical properties of the aortic root anatomy, including the perimeter and area of the virtual aortic valve annulus and coronary heights, were determined from 3D whole-heart MRI and cardiac CTA (CCTA) images, respectively. The diameters of the aorta (thoracic and abdominal aorta) and iliofemoral arteries were measured from REACT and aortic CTA (ACTA) images, respectively. A paired t-test was used to compare these two modalities. Bland-Altman plots were used to assess cardiovascular MRI and CTA measurements. Transcatheter heart valve (THV) sizing was performed based on CCTA measurements and compared with 3D whole-heart MRI measurements. The extent of annular calcification on 3D whole-heart MRI images was evaluated by a four-point grading scale and compared with CCTA data. All 30 patients completed CTA and cardiovascular MRI examinations, with the TAVI procedure being administered in 25 patients. The mean acquisition time of the comprehensive MRI protocol was 18 ± 3.2 min. There were no significant differences between ACTA and REACT data in regard to the diameters of aortic and iliofemoral arteries, including the ascending thoracic aorta (37 ± 4.6 mm vs. 37.7 ± 5.2 mm, p = 0.085), descending thoracic aorta (24.3 ± 2.8 mm vs. 24.3 ± 2.8 mm, p = 0.832), abdominal aorta (20.9 ± 2.5 mm vs. 20.8 ± 2.5 mm, p = 0.602), bilateral common iliac arteries (right: 8.36 ± 1.44 mm vs. 8.42 ± 1.27 mm, p = 0.590; left: 8.61 ± 1.71 mm vs. 8.86 ± 1.46 mm, p = 0.050), and bilateral femoral arteries (right: 6.77 ± 1.06 mm vs. 6.87 ± 1.00 mm, p = 0.157; left: 6.75 ± 1.02 mm vs. 6.90 ± 0.80 mm, p = 0.142). Both modalities showed similar aortic valve morphology and semi-quantitative valve calcification (all, p's > 0.05). Overall agreement for implanted THV was found in all 25 (100%) patients assessed with both modalities. REACT combined with 3D whole-heart MRI enables reliable measurements of aortic root anatomy, annular calcification, and aorta and iliofemoral access in patients under evaluation for TAVI.

Transcatheter aortic valve implantation with commissural alignment

Transcatheter aortic valve implantation (TAVI) is commonly accepted method of treatment of aortic stenosis in most patients with currently increasing number of TAVI procedures. Patients after TAVI frequently have indications for percutaneous coronary intervention (PCI) that might be technically challenging due to the presence of transcatheter valve. Compromising coronary ostia involves such issues as design of the prosthesis and its position in the aortic root with respect to the commissures of native aortic valve. Since TAVI with commissural alignment can mitigate risk of compromising coronary ostia, this option should be considered while planning TAVI, especially in younger patients with coronary atherosclerosis and relatively high probability of PCI in the future. The algorithm of commissural alignment in clinical practice of TAVI up to date has been proposed only for several transcatheter heart valves reported in this paper.

Comparison of the effect of surgical versus transcatheter aortic valve replacement on the development of postoperative acute kidney injury.

Acute kidney injury (AKI) frequently occurs after cardiac surgery. Recently, transcatheter aortic valve implantation (TAVI), a less invasive option for aortic stenosis (AS), has been increasingly performed, particularly in elderly patients. We retrospectively investigated and compared the incidence and risk factors of postoperative AKI in patients who underwent surgical aortic valve replacement (SAVR) and TAVI. This was a retrospective single-center study. Seven days postoperatively, data were obtained from medical records. Patients were classified into SAVR and TAVI groups based on age, according to the policy of the Japanese Circulation Society. A total of 155 patients underwent surgery for AS between January 2020 and December 2021. Variables included age, sex, risk score, preoperative left ventricular ejection fraction, hypertension, and renal dysfunction. AKI was defined in accordance with the Kidney Disease: Improving Global Outcomes criteria. A total of 33 SAVR and 79 TAVI procedures were included in this study. The incidences of AKI in the SAVR and TAVI groups were 45.5% and 43.0%, respectively. No significant differences existed between the two groups. Weight (p = 0.0392) and pre-renal dysfunction (p = 0.0308) affected the incidence of AKI in the SAVR group, whereas no such variables were identified in the TAVI group. Within the current age-based treatment selection criteria for AS, no significant difference in the incidence of AKI was observed between the two procedures.Although preoperative renal function may be associated with postoperative AKI, further studies are required to select the optimal surgical procedure for patients with renal dysfunction.

Coronary angiography and intervention after transcatheter aortic valve implantation (TAVI): the nationwide SWEDEHEART registry

Abstract Background Coronary access after transcatheter aortic valve implantation (TAVI) can be challenging and complicate percutaneous coronary intervention (PCI). Therefore, pre-existing severe coronary stenosis is usually treated either before or during the TAVI procedure. However, due to the progressive nature of coronary artery disease (CAD), some patients require urgent or elective coronary angiography and intervention after their TAVI procedure. Purpose To assess the indication, the incidence, and feasibility of coronary angiography and intervention after TAVI. Methods All patients undergoing TAVI between 2008 and 2021 from the Swedish Transcatheter Cardiac Intervention Registry (SWENTRY) were included. SWENTRY was further linked to the Swedish Coronar Angiography and Angioplasty Registry (SCAAR) and the National Cause of Death Registry. Results Among 8819 patients undergoing TAVI, 697 angiograms were performed in 515 patients (5.8%) after TAVI (43.1 % after balloon-expandable bioprosthesis, 49.5 % after self-expandable bioprosthesis) at a median follow up of 841 days (interquartile range: 346 to 1457 days). PCI was performed in 347 patients (49.8%) with a success rate of 92.5% with no significant differences between patients implanted with balloon-expandable and self-expandable bioprostheses (93.0% vs.91.5%; p=0.62). The most common indications for PCI after TAVI were non-ST elevation acute coronary syndrome (NSTE-ACS) (45.8%), chronic coronary syndrome (30.3%), ST elevation myocardial infarction (6.9%) and congestive heart failure (3.5%). The cumulative incidence of angiograms with or without PCI at 30 days, 1 year, 2 years and 5 years were 6.9, 37.2, 60.2 and 90.2 percent of the total number of angiograms respectively (Figure). Conclusion Coronary angiogram and interventions after TAVI are rare, with an incidence declining over time after TAVI. The main indication for coronary angiogram and PCI was NSTE-ACS. PCIs were successfully performed after TAVI, with no apparent differences between balloon-expandable and self-expandable bioprostheses.

Efficacy of Intravascular Lithotripsy (IVL) in peripheral lesions with severe calcification and its use in TAVI procedure: A systematic review and meta-analysis

Abstract Background Heavily calcified peripheral artery lesions increase the risk of vascular complications, constituting a severe challenge for the operator. Intravascular Lithotripsy (IVL) technology disrupts subendothelial calcification by using localized pulsative sonic pressure waves and is a promising technique for patients with severe calcification in peripheral arteries. Purpose Our aim was to systematically review and summarize available data regarding the safety and efficacy of IVL in preparing severely calcified plaques in peripheral arteries and its use in Transcatheter Aortic Valve Implantation (TAVI). Methods This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 23, 2023, for studies assessing the characteristics and outcomes of patients undergoing IVL in peripheral vasculature. The diameter of the vessel lumen before and after IVL was estimated. The occurrence peri-procedural complications were assessed using a random-effects model. Results 20 studies with a total of 1,223 patients with heavily calcified peripheral lesions were analyzed. The mean age of the cohort was 73.8 ± 8.9 years. Successful IVL delivery achieved in 100% (95% CI: 100%-100%, I2=0%), with an increase in the luminal diameter (SMD: 4.66, 95% CI: 3.41-5.92, I2=90.8%) and reduction in diameter stenosis (SMD: -4.15, 95% CI: -4.75 to -3.55, I2=92.8%), and a described low rate of complications. There was not observed any dissection in 97% (95% CI: 91%-100%, I2=81.4%), while dissections of any type (A, B, C, or D) were observed in 6% (95% CI: 2%-10%, I2=85.3%) of the patients. Several rare cases of abrupt closure, no-reflow phenomenon, perforation, thrombus formation, and distal embolization were recorded. Finally, the subgroup analysis of patients who underwent a TAVI with IVL assistance presented successful implantation in 100% (95% CI: 100%-100%, I2=0%) of the cases, with only 4% (95% CI: 0%-12%, I2=68.96%) presented dissections of any sort. Conclusions IVL seems to be an effective and safe technique for preparing severely calcified lesions in peripheral vessels during TAVI interventions. These results support the use of IVL for amelioration of overall outcome in high vascular risk TAVI settings.

Impact of procedure-related increase in plasma creatinine after transcatheter aortic valve implantation: a nationwide study

Abstract Background In patients undergoing transcatheter aortic valve implantation (TAVI), the impact of plasma creatinine (PCreat) increase on the prognosis and on future kidney function is sparsely examined and data from large, nationwide cohorts are warranted. Purpose To examine the long-term risk of dialysis treatment, mortality, and major adverse kidney event according to PCreat level increments in the periprocedural setting of TAVI. Methods With Danish nationwide registries, we identified all patients undergoing TAVI from 2014–2021. According to two PCreat blood samples (the latest measured value between 365–7 days prior to TAVI and the highest measured value within 21 days after TAVI), patients were classified according to percent increase in PCreat: 1) &amp;lt;25%, 2) 25–49%, and 3) ≥50%. With a maximum of one year of follow-up, we used Aalen-Johanson estimator to examine the cumulative incidence frequency (CIF) of first-time dialysis treatment and major adverse kidney event and Kaplan-Meier estimates to assess all-cause mortality. Major adverse kidney event was defined as either of three: initiation of dialysis treatment, mortality, or an admission with a diagnosis code of acute kidney injury. Adjusted rates of outcomes were assessed, using multivariable Cox analysis, with patients with &amp;lt;25% PCreat increase serving as reference. Results We identified 4,029 patients undergoing a first-time TAVI procedure (57.0% male, median age 81 year); 3,343 (83.0%) patients with &amp;lt;25% PCreat increase, 462 (11.5%) with 25–49% PCreat increase, and 224 (5.6%) with ≥50% PCreat increase. Compared with &amp;lt;25% PCreat increase, the adjusted one-year rate of dialysis treatment showed no statistical difference in patients with 25-49% PCreat increase (hazard ratio [HR] 1.52 [95%CI, 0.74–3.11]), while patients with ≥50% PCreat increase had an increased associated one-year rate of dialysis treatment (HR 3.62 [95%CI, 1.90–6.90]) (Figure). The adjusted one-year rate of mortality was increased in both patients with 25-49% PCreat increase (HR 1.78 [95%CI, 1.29–2.45]) and ≥50% PCreat increase (HR 2.87 [95%CI, 1.97–4.18]). The adjusted one-year rate of major adverse kidney event was increased in both patients with 25-49% PCreat increase (HR 1.69 [95%CI, 1.25–2.28]) and ≥50% PCreat increase (HR 3.03 [95%CI, 2.17–4.23]). Conclusion In patients undergoing TAVI, a PCreat increase of ≥25% was associated with increased one-year rates of mortality and major adverse kidney event, while an increase ≥50% carried a more than threefold increased rate of incident dialysis treatment and increased rates of mortality and major adverse kidney event.

Abstract 12022: Transcatheter Aortic Valve Implantation Wait-Time Management: Derivation and Validation of the Canadian TAVI Triage Tool (CAN3T)

Introduction: Transcatheter aortic valve implantation (TAVI) for patients with aortic stenosis has seen indication expansion and exponential growth in demand over the last decade. In many jurisdictions the growing demand outpaced capacity, increasing wait-times and pre-procedural adverse events. Objective: To derive prediction models that estimate the risk of adverse events on the waitlist that would inform the development of a triage tool for use by clinicians to identify patients who should be prioritized for TAVI. Methods: We conducted an observational retrospective cohort study using population-based administrative data from Ontario, Canada. Adult patients referred for TAVI from April 1 st , 2012 to March 31 st , 2020 were included and followed-up to the first of: death, TAVI procedure, removal from waitlist, or end of the observation period. We used competing risk subdistributions hazards models to find significant predictors for each of the following outcomes: (1) all-cause death while on the waitlist, (2) all-cause hospitalization while on the waitlist, (3) receipt of urgent TAVI, and (4) a composite of outcomes 1-3. The median predicted risk in our population at 12 weeks was chosen as a threshold for a maximum acceptable risk while on the waitlist, and was incorporated in the triage tool to recommend individualized wait-times. Results: We included 13,128 patients in the analyses. 586 (4.46%) patients died on the waitlist, and 4,343 (33.08%) had at least one all-cause hospitalization. 6,854 TAVIs were completed, of which 1,135 (16.56%) were urgent procedures. We were able to create parsimonious models for each outcome that included clinically relevant predictors. Optimism-corrected C-statistics varied from 0.63 to 0.75, optimism-corrected Brier scores from 0.03 to 0.19, and the calibration slopes from 0.79 to 0.99. Conclusions: We developed the Canadian TAVI Triage Tool (CAN3T), a triage tool to assist clinicians in the prioritization of patients who should have timely access to TAVI. We anticipate that the CAN3T will be a valuable support tool for patients and clinicians, with the potential of bringing meaningful changes to the health system as it may improve equity in access to care, reduce preventable adverse events and improve system efficiency.

Abstract 14323: Significance of Angio-IMR to Predict Heart Failure Post-TAVI

Background/Introduction: The number of transcatheter aortic valve implantation (TAVI) procedures is currently increasing. However, a substantial number of patients suffer from repeated heart failure (HF) after the TAVI procedure. The association between Index of Microvascular Resistance (IMR) and HF is already known, especially in HFpEF. Purpose: The aim of this study was to assess the prognostic significance of IMR for HF after TAVI. Method and Result: 120 consecutive patients who underwent coronary angiography (CAG) before undergoing TAVI in our hospital between 2018 and 2021 were included in the analysis. Quantitative Flow Ratio (QFR) analysis was performed for each coronary artery, excluding cases undergoing PCI before or after TAVI. The angiography derived IMR was then obtained from the QFR values. Finally, 65 patients were available for IMR analysis. Of these, 12 were hospitalized or underwent medical intensification for HF exacerbations after TAVI. IMR was significantly higher in patients with HF compared without HF. (73.8 (31 to 121) vs 59.7 (26 to 153), p=0.041) No other significant differences were found in age, QFR values, EF, i-EOA on echocardiography after TAVI, STS score, and BNP values before TAVI. All patients with HF were female. Conclusion: It is suggested that angio-derived IMR values before TAVI might be a useful predictor of heart failure after TAVI.

Early safety and mid-term clinical outcomes of technology transfer of transcatheter aortic valve implantation in patients with severe aortic valve stenosis in Vietnam: a single-center experience of 90 patients

This study investigated the early safety and mid-term outcomes of stepwise implementation of transcatheter aortic valve implantation (TAVI) in Vietnamese patients with severe aortic stenosis (AS) at a single center, following the process of technical transfer. From 2017 to 2022, 90 patients with symptomatic severe AS underwent TAVI at a tertiary hospital in Vietnam. The first 30 cases received support for technology transfer from international proctors. One-year outcomes were evaluated using the Valve Academic Research Consortium-2 (VARC-2) criteria. Forty patients (45.5%) had bicuspid aortic valve (BAV). The Medtronic Evolut R/Pro self-expanding valve system was used in 98.9% of all cases, with a 29-mm valve being the most common. Device success was achieved in 95.6% of cases, whereas one procedural death occurred. At one year, four deaths (5.3%) occurred and all were in the BAV group. Other complications included stroke (2.8%), hospital readmission due to the valve or worsening heart failure (2.8%), permanent pacemaker implantation (9.9%), and moderate paravalvular leak (3.0%). The left ventricular ejection fraction and mean transvalvular gradient significantly improved after TAVI. There were no significant differences in procedural success and mortality when the proctor support period and the subsequent solo operator period were compared. TAVI procedure is safe for treating severe AS in Vietnamese patients, despite the high prevalence of BAV. The procedural complication rate was low, with promising outcomes at one year. These results also highlight the effectiveness of the TAVI technical transfer model in Vietnam. No funding was provided for this study.

Outcomes of emergent cardiac surgery after transcatheter aortic valve implantation.

The aim of this study was to evaluate the reasons for emergent cardiac surgery (ECS) after transcatheter aortic valve implantation (TAVI) and assess outcomes of these patients. All patients undergoing ECS following acomplicated TAVI procedure at ahigh-volume TAVI centre in the Netherlands from 1January 2008 to 1April 2022 were included. Baseline and procedural characteristics and outcome data (procedural, 30-day and 1‑year mortality, in-hospital stroke, 30-day pacemaker implantation, 30-day vascular complications, 30-day deep sternal wound infections and 30-day re-exploration) were collected from patient files and analysed using descriptive statistics. During the study period, 16of 1594 patients (1.0%) undergoing TAVI required ECS. The main reason for ECS was valve embolisation (n = 9; 56.3%), followed by perforation of the left/right ventricle with guide wire/pacemaker lead (n = 3; 18.8%) and annular rupture (n = 3; 18.8%). Procedural, 30-day and 1‑year mortality was 0%, 18.8% (n = 3) and 31.3% (n = 5), respectively. In-hospital stroke occurred in 1patient (6.3%), apacemaker was implanted at 30days in 2patients (12.5%), and major vascular complications did not occur. ECS following complicated TAVI was performed in only asmall number of cases. It had ahigh but acceptable perioperative and 30-day mortality, taking into account the otherwise lethal consequences. In case of valve embolisation, no periprocedural or 30-day mortality was observed for surgical aortic valve replacement (even in aredo setting), which supported the necessity to perform TAVI in centres with cardiac surgical backup on site.

Emergency Treatment of Acute Decompensated Severe Aortic Stenosis with Transcatheter Aortic Valve Implantation under the Coplane View Using J-Tipped Wires Fluoroscopy

Patients experiencing severe aortic stenosis with acute decompensation often face elevated surgical aortic valve replacement risks, leading to high postoperative mortality rates. However, for some patients eligible for transcatheter aortic valve implantation (TAVI), computed tomography angiography for assessing the aortic root and coronary artery might be challenging before the TAVI procedure. This case highlights a patient who underwent emergency TAVI guided by coplane view generated using J-tipped wires fluoroscopy without computed tomography evaluation before the TAVI. This approach reduces contrast usage during the TAVI procedure, significantly mitigating the risks of renal injury and heart function deterioration.

Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire: SAFE-TAVI Trial

BackgroundThe SavvyWire (OpSens Inc) is a 0.035-inch preshaped guidewire with dedicated pacing properties and a distal pressure sensor allowing for continuous hemodynamic pressure monitoring. ObjectivesThis study sought to determine the efficacy and safety of the guidewire during transcatheter aortic valve replacement (TAVR) procedures. MethodsThis prospective, multicenter clinical study included patients with severe aortic stenosis undergoing TAVR in 8 European centers. The primary efficacy endpoint was defined as effective left ventricular rapid pacing runs with the guidewire translating into a significant systemic pressure drop (below 60 mm Hg). The safety outcome included the absence of major procedural complications related to the guidewire. ResultsA total of 121 patients (mean age: 82.2 ± 5.9 years, 50% women) were included in the study, and 119 (98.3%) patients were finally treated with the study device. A balloon-expandable valve was implanted in 45 (37.8%) patients. Predilatation and postdilatation were performed in 89 (74.8%) and 14 (11.8%) patients, respectively. The primary efficacy endpoint was achieved in 116 (98.3%) patients, and the mean aortic systolic arterial pressure achieved during rapid pacing was 46.6 ± 11.3 mm Hg. Hemodynamic assessment with the use of the OptoMonitor 3 (OpSens Inc) without additional catheter exchange was achieved in 117 (99.2%) patients. The safety endpoint was achieved in 117 (99.2%) patients. No procedural mortality, stroke, or ventricular perforation was reported. ConclusionsThe use of the guidewire during TAVR procedures appeared to be efficacious and safe. This device could help minimize interventions during the procedure and improve the clinical decision making after transcatheter heart valve deployment. (SavvyWire Efficacy and Safety in Transcatheter Aortic Valve Implantation Procedures [SAFE-TAVI]; NCT05492383)

Healthcare provision of transcatheter aortic valve implantation in Germany.

Transcatheter aortic valve implantation (TAVI) for aortic stenosis in older patients is the standard of care with awell-established supply density in Germany. In the near future, healthcare reform is planned that may affect TAVI capacities. Therefore, it is important to know how political regulations may interfere with access to services and what the need for TAVI will be in the future, based on demographic trends. The number of TAVI procedures (DRG F98A +F98) and the in-hospital main diagnoses of aortic stenosis (ICD I35) in 2021 were analyzed at the level of county or federal state based on anonymized data from hospital reports, according to §21 of the German hospital reimbursement law. The number of TAVI and aortic stenosis cases was projected for 2035 based on data from the German Federal Statistical Office on demographic developments. With quality assurance data from hospitals in 2019 and aroute planner, the travel time to the next hospital performing TAVI (OPS 5‑35a.0) was calculated, and the consequence of apolitically suggested minimum volume cut-off was analyzed. In 2021, atotal of 26,506 TAVI procedures were reported with amean number of TAVI per 100,000 inhabitants of32 (range between federal states from25 to42). Among the 66,045 diagnoses of aortic stenosis, there was avariation per 100,000 inhabitants from64 to 108 (mean79) between federal states. Compared to 2021, an additional 8748 (+13%) diagnoses of aortic stenosis and an increase of 4673 (+18%) TAVI procedures is to be expected in 2035. In 2019, 57% of German citizens could reach aTAVI hospital within 30 min and 91% within 60 min of driving time by car (mean time to hospital 31 min). Applying aminimum number of 150 TAVI/hospital per year would increase the driving time to hospital from 33to 52 min in Saxony-Anhalt and instantly remove six out of eight hospitals from service in Hesse. Regulation of TAVI services by minimum volume numbers would arbitrarily interfere with access to services, in contradiction to the medical service assurance tasks of federal state governments. These issues should be considered in the upcoming healthcare system reform.

TAVI-PREP: A Deep Learning-Based Tool for Automated Measurements Extraction in TAVI Planning.

Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to open-heart surgery for treating severe aortic stenosis. Despite its benefits, the risk of procedural complications necessitates careful preoperative planning. This study proposes a fully automated deep learning-based method, TAVI-PREP, for pre-TAVI planning, focusing on measurements extracted from computed tomography (CT) scans. The algorithm was trained on the public MM-WHS dataset and a small subset of private data. It uses MeshDeformNet for 3D surface mesh generation and a 3D Residual U-Net for landmark detection. TAVI-PREP is designed to extract 22 different measurements from the aortic valvular complex. A total of 200 CT-scans were analyzed, and automatic measurements were compared to the ones made manually by an expert cardiologist. A second cardiologist analyzed 115 scans to evaluate inter-operator variability. High Pearson correlation coefficients between the expert and the algorithm were obtained for most parameters (0.90-0.97), except for left and right coronary height (0.8 and 0.72, respectively). Similarly, the mean absolute relative error was within 5% for most measurements, except for left and right coronary height (11.6% and 16.5%, respectively). A greater consensus was observed among experts than when compared to the automatic approach, with TAVI-PREP showing no discernable bias towards either the lower or higher ends of the measurement spectrum. TAVI-PREP provides reliable and time-efficient measurements of the aortic valvular complex that could aid clinicians in the preprocedural planning of TAVI procedures.