Impact of cerebral protection on observed versus predicted in-hospital stroke in a high stroke risk TAVR cohort.

BACKGROUND: Despite impressive improvements in the safety profile of Transcatheter aortic valve replacement (TAVR), the risk for peri-procedural stroke after TAVR has not declined substantially. In an effort to reduce periprocedural stroke, cerebral embolic protection (CEP) devices have been utilized but have yet to demonstrate benefit in all-comers. There is a paucity of data supporting the utilization of CEP in TAVR patients with an anticipated high risk for peri-procedural stroke. METHODS: The Transcatheter Aortic Valve Replacement In-Hospital Stroke (TASK) score is a clinical risk tool for predicting the in-hospital stroke risk of patients undergoing transfemoral TAVR. This score was used to identify high-risk patients and calculate the expected in-hospital stroke risk. This was a single-centre cohort study in all consecutive TAVR patients who had placement of CEP. The observed versus expected ratio for peri-procedural stroke was calculated. To obtain 95% credible intervals, we used 1000 bootstrapped samples of the original cohort sample size without replacement and recalculated the TASK predicted scores. RESULTS: The study included 103 patients. The median age was 83 (IQR 78,89). 63 were male (61.1%) and 45 (43.69%) had a history of previous Stroke or TIA. Two patients had an in-hospital stroke after TAVR (1.94%). The expected risk of in-hospital stroke based on the TASK score was 3.39% (95% CI 3.07-3.73). The observed versus expected ratio was 0.57 (95% CI 0.52-0.64). CONCLUSION: In this single-center study, we found that in patients undergoing TAVR with high stroke risk, CEP reduced the in-hospital stroke risk by 43% when compared with the risk-score predicted rate. CLINICAL TRIAL NUMBER: N/A.

A risk model of mortality rate in dialysis patients following transcatheter aortic valve replacement.

BACKGROUND: Dialysis patients undergoing transcatheter aortic valve replacement (TAVR) generally have poor prognosis compared with non-dialysis patients. Furthermore, there are few reliable risk models in this clinical setting. Therefore, we aimed to establish a risk model in dialysis patients undergoing TAVR that would be informative for their prognosis and the decision-making process of TAVR. METHODS: A total 118 dialysis patients (full cohort) with severe aortic stenosis underwent TAVR in our institute between 2012 and 2022. The patients of the full cohort were randomly assigned to two groups in a 2:1 ratio to form derivation and validation cohorts. Risk factors contributing to deaths were analyzed from the preoperative variables and a risk model was established from Cox proportional hazard model. RESULTS: There were 69 deaths following TAVR derived from infectious disease (43.5 %), cardiovascular-related disease (11.6 %), cerebral stroke or hemorrhage (2.9 %), cancer (1.4 %), unknown origin (18.8 %), and others (21.7 %) during the observational period (811 ±â€¯719 days). The cumulative overall survival rates using the Kaplan-Meier method at 1 year, 3 years, and 5 years in the full cohort were 82.8 %, 41.9 %, and 24.2 %, respectively. An optimal risk model composed of five contributors: peripheral vascular disease, serum albumin, left ventricular ejection fraction < 40 %, operative age, and hemoglobin level, was established. The estimated C index for the developed models were 0.748 (95 % CI: 0.672-0.824) in derivation cohort and 0.705 (95 % CI: 0.578-0.832) in validation cohort. The prediction model showed good calibration [intraclass correlation coefficient = 0.937 (95%CI: 0.806-0.981)] between actual and predicted survival. CONCLUSIONS: The risk model was a good indicator to estimate the prognosis in dialysis patients undergoing TAVR.

The functional impact on donor vessel following transcatheter closure of coronary artery fistulas-a retrospective study using QFR analysis.

Background: The impact of transcatheter closure of coronary artery fistula (CAF) and residual shunt after occlusion on improving blood flow in the donor vessel remains uncertain. Objectives: To evaluate the functional impact on the donor vessel following CAFs closure using QFR (Quantitative Flow Ratio) analysis. Methods: A total of 46 patients with 48 CAFs who underwent transcatheter closure at Shanghai Chest Hospital and Shuguang Hospital between March 2015 and August 2023 were included in the review. The clinical, angiographic details, and QFR data were subjected to analysis. The size of the fistulae was defined according to the ratio between the diameters of the fistulae and the largest diameter of the coronary vessel not feeding the coronary fistula. Results: Among 48 CAFs, the average diameter of the fistulae ostium was 3.19 ± 1.04 mm, while the mean diameter of the donor vessel segment following fistulae was 3.45 ± 1.01 mm. The mean QFR value of the donor vessels with medium CAFs was found to be significantly lower than those with small CAFs (0.93 ± 0.10 vs. 0.98 ± 0.03; p < 0.05). Furthermore, the mean QFR value of donor vessels with medium CAFs was observed to be significantly improved after occlusion (0.99 ± 0.01 vs. 0.93 ± 0.10; p = 0.01). However, there was no statistical difference in the mean QFR value of donor vessels with small CAFs before and after occlusion (0.98 ± 0.03 vs. 0.98 ± 0.02; p > 0.05). Moreover, the changes in QFR were more pronounced in donor vessels with medium CAFs compared to those with small CAFs after occlusion (0.06 ± 0.10 vs. 0.005 ± 0.012; p = 0.01). There is no statistical difference in the mean QFR variation and QFR variation rate between donor vessels with CAFs that occurred residual shunt and those without residual shunt after occlusion (p > 0.05). Conclusions: The presence of medium CAFs has a significant impact on the blood flow of the donor vessel, as compared to small CAFs, and may benefit from occlusion. A small residual shunt has no significant impact on the effectiveness of CAFs occlusion in enhancing donor blood flow.

Transcatheter Pulmonary Valve Replacement in Middle and Late Adulthood.

Transcatheter pulmonary valve replacement (TPVR) is now frequently performed in adult congenital heart disease (ACHD) patients. As the life-expectancy of the ACHD population continues to improve, more patients will require pulmonary valve intervention. This study details the short-term and mid-term clinical outcomes of patients aged 40 years and older undergoing TPVR. We performed an institutional retrospective cohort study that included patients aged 40 and older undergoing TPVR (and clinical follow up) from January 1, 2012 to January 1, 2024. Descriptive analyses, Kaplan-Meier survival analysis, and Cox proportional hazard modeling were utilized to determine outcomes and risk factors affecting survival. The study included 67 patients and median age at TPVR was 48 [43,57] years. Median hospital length of stay following TPVR was 1 [1,3] day, peri-procedural complications occurred in 5 patients and acute kidney injury occurred in 1 patient. Median duration of follow-up was 3.5 [0.1,9.7] years. There were 9 total deaths and 1, 3, and 5-year Kaplan-Meier survival after TPVR was 95%, 91%, and 82%, respectively. Moderate or worse right ventricular dysfunction was present in 22 patients before TPVR and in 20 patients after TPVR. Inpatient status prior to TPVR negatively impacted survival (HR = 24.7 [3.3, 186.1], p=0.002). In conclusion, TPVR was performed in patients ages 40 and older with favorable periprocedural and mid-term follow-up outcomes including survival, but right ventricular dysfunction did not improve and further exploration on ideal timing of TPVR in this age group is warranted.

Association of Mitral Valve Geometry at CT with Secondary Mitral Regurgitation after Transcatheter Aortic Valve Replacement in Patients with Aortic Regurgitation.

Background: The improvement rate and predictors of secondary mitral regurgitation in patients with aortic regurgitation undergoing transcatheter aortic valve replacement (TAVR) remain unclear. This study aimed to identify predictors of persistent moderate to severe secondary mitral regurgitation after TAVR in patients with aortic regurgitation by assessing mitral valve geometry with computed tomography (CT). Methods: This retrospective cohort study reviewed 242 consecutive patients with aortic regurgitation who underwent TAVR between May 2014 and December 2022. Patients with primary or less than moderate mitral regurgitation were excluded. Mitral annular dimensions (area, perimeter, anteroposterior, intercommissural, and trigone-to-trigone diameter), mitral valve tenting geometry (mitral valve tenting area [MVTA] and mitral valve tenting height [MVTH]), and papillary muscle displacement were systematically measured at CT. Mitral regurgitation improvement was assessed at 3 months after TAVR by echocardiography. Logistic regression was performed to explore the association of mitral valve geometry with mitral regurgitation improvement after TAVR. Results: A total of 75 patients (mean age, 74 ± 7 years; 32.0% female) with moderate to severe secondary mitral regurgitation were included in the final analysis. Mitral regurgitation improved in 49 patients and remained unchanged in 26 patients. Mitral annular dimensions, including area, perimeter, anteroposterior, and intercommissural diameter, were associated with mitral regurgitation improvement. MVTA and MVTH were risk factors for sustained mitral regurgitation. In addition, QRS duration > 120 ms and atrial fibrillation had an impact on the mitral regurgitation improvement. Mitral annular area (odds ratio [OR], 1.41; 95% confidence interval [CI]: 1.05, 1.90; p = 0.02) and MVTA (OR, 7.24; 95% CI: 1.72, 30.44; p = 0.007) were independent predictors of persistent secondary mitral regurgitation after TAVR. Conclusions: Mitral annular area and MVTA were independent predictors of persistent secondary mitral regurgitation after TAVR.

Effective use of fibrinogen concentrate in a pediatric splenic injury requiring transcatheter arterial embolization.

Correction of coagulation is a crucial aspect of trauma care. While there are reports highlighting the effectiveness of fibrinogen concentrate in severe trauma cases with coagulopathic complications, literature on its use in pediatric cases remains limited. This paper discusses the case of a 5-year-old male presenting with a splenic injury and associated coagulopathy. We administered fibrinogen concentrate to enhance his coagulability prior to performing transcatheter arterial embolization utilizing gelatin sponges, aiming for optimal hemostasis. Post-administration, the patient's fibrinogen levels improved significantly, leading to successful hemostasis and a positive clinical outcome.

Clinical Significance of Diffusion-Weighted Brain MRI Lesions After TAVR: Results of a Patient-Level Pooled Analysis.

BACKGROUND: Acute brain infarction detected by diffusion-weighted magnetic resonance imaging (DW-MRI) is common after transcatheter aortic valve replacement (TAVR), but its clinical relevance is uncertain. OBJECTIVES: The authors investigated the relationship between DW-MRI total lesion number (TLN), individual lesion volume (ILV), and total lesion volume (TLV) and clinical stroke outcomes after TAVR. METHODS: Patient-level data were pooled from 4 prospective TAVR embolic protection studies, with consistent predischarge DW-MRI acquisition and core laboratory analysis. C-statistic was used to determine the best DW-MRI measure associated with clinical stroke. RESULTS: A total of 495 of 603 patients undergoing TAVR completed the predischarge DW-MRI. At 30 days, the rate of clinical ischemic stroke was 6.9%. Acute ischemic brain injury was seen in 85% of patients with 5.5 ± 7.3 discrete lesions per patient, mean ILV of 78.2 ± 257.1 mm3, and mean TLV of 555 ± 1,039 mm3. The C-statistic was 0.84 for TLV, 0.81 for number of lesions, and 0.82 for maximum ILV in predicting ischemic stroke. On the basis of the TLV cutpoint as defined by receiver operating characteristic (ROC), patients with a TLV >500 mm3 (vs TLV ≤500 mm3) had more ischemic stroke (18.2% vs 2.3%; P < 0.0001), more disabling strokes (8.8% vs 0.9%; P < 0.0001), and less complete stroke recovery (44% vs 62.5%; P = 0.001) at 30 days. CONCLUSIONS: Our study confirms that the number, size, and total volume of acute brain infarction defined by DW-MRI are each associated with clinical ischemic strokes, disabling strokes, and worse stroke recovery in patients undergoing TAVR and may have value as surrogate outcomes in stroke prevention trials. (A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During TAVI [DEFLECT III]; NCT02070731) (A Study to Evaluate the Neuro-embolic Consequences of TAVR [NeuroTAVR]; NCT02073864) (The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation [REFLECT I]; NCT02536196) (The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation [REFLECT II]; NCT02536196).

Incidence, Predictors, and Prognostic Impact of Neurologic Events After TAVR According to VARC-3 Criteria.

BACKGROUND: The Valve Academic Research Consortium (VARC)-3 definition for neurologic events after transcatheter aortic valve replacement (TAVR) lacks clinical validation. OBJECTIVES: This study sought to determine the incidence, predictors, and clinical impact of neurologic events following TAVR as defined by VARC-3 criteria. METHODS: This was a multicenter study including 2,924 patients with severe aortic stenosis undergoing TAVR. Based on Neurologic Academic Research Consortium (NeuroARC) classification, neurologic events were classified as NeuroARC type 1 (stroke), NeuroARC type 2 (covert central nervous system injury), and NeuroARC type 3 (transient ischemic attack and delirium). Baseline, procedural, and follow-up data were prospectively collected in a dedicated database. RESULTS: After a median follow-up of 13 (7-37) months, neurologic events occurred in 471 patients (16.1%), NeuroARC type 1, 2, and 3 in 37.4%, 4.7%, and 58.0% of cases, respectively, and the majority (58.6%) were periprocedural. Advanced age, chronic kidney disease, atrial fibrillation, major vascular complications, and in-hospital bleeding determined an increased risk of periprocedural events (P < 0.03 for all). Neurologic events occurring during the periprocedural time frame were independently associated with a substantial increase in mortality at 1 year after the intervention (HR: 1.91; 95% CI: 1.23-2.97; P = 0.004). However, although NeuroARC type 1 was associated with an increased mortality risk (IRR: 3.38; 95% CI: 2.30-5.56; P < 0.001 and IRR: 21.7; 95% CI: 9.63-49.1; P < 0.001 for ischemic and hemorrhagic stroke, respectively), the occurrence of NeuroARC type 3 events had no impact on mortality. CONCLUSIONS: Neurologic events after TAVR were associated with poorer short- and long-term survival. This correlation was related to the type of NeuroARC event defined by the VARC-3 criteria. Given the negative impact on clinical outcomes, every attempt should be made to reduce the risk of neurologic complications after TAVR.

Early vs. Late Transcatheter Aortic Valve Replacement in Acute Heart Failure Hospitalizations: A Comparative Nationwide Analysis.

BACKGROUND: Severe aortic stenosis (AS) is the most common valvular disease in the USA. Patients undergoing urgent or emergent transcatheter aortic valve replacement (TAVR) have worse clinical outcomes than those undergoing non-urgent procedures. No studies have examined the impact of procedural TAVR timing on outcomes in AS complicated by acute heart failure (AHF). AIMS: We aimed to evaluate differences in in-hospital mortality and clinical outcomes between early (<48 hours) vs. late (≥48 hours) TAVR in patients hospitalized with AHF using a real-world US database. METHODS: We queried the National Inpatient Sample database to identify hospitalizations with a diagnosis of AHF, aortic valve disease, and a TAVR procedure (2015-2020). The associations between TAVR timing and clinical outcomes were examined using logistic regression model. RESULTS: A total of 25,290 weighted AHF hospitalizations were identified, of which 6,855 patients (27.1%) underwent early TAVR, and 18,435 (72.9%) late TAVR. Late TAVR patients had higher in-hospital mortality rate (2.2% vs. 2.8%, p<0.01) on unadjusted analysis but no significant difference following adjustment for demographic, clinical, and hospital characteristics [aOR 1.00 (0.82-1.23)]. Late TAVR was associated with higher odds of cardiac arrest (aOR 1.50, 95% CI: 1.18-1.90) and use of mechanical circulatory support (aOR 2.05, 95% CI: 1.68-2.51). Late TAVR was associated with longer hospital stay (11 days vs. 4 days, p<0.01) and higher costs ($72,851 vs. $53,209, p<0.01). CONCLUSION: Early TAVR was conducted in approximately 25% of the AS patients admitted with AHF, showing improved in-hospital outcomes before adjustment, with no significant differences observed after adjustment.

Impact of comorbidity on complication rates and life expectancy in patients with a leadless pacemaker.

BACKGROUND: Knowledge about impact of age and comorbidities on outcome in patients with leadless pacemakers (LPM) is limited. OBJECTIVES: To analyse outcome in LPM patients according to age and comorbidities. METHODS: This Swiss, multi-centre, retrospective analysis includes all patients with LPM implanted between 2015 and 2022. Charlson-Comorbidity-Index (CCI) was determined and patients were divided into a low- (CCI ≤ 5) and high- comorbidity (CCI > 5) group. Peri-procedural complications, in-hospital death, and all-cause mortalities were assessed. Finally, all-cause mortality according to three groups (CCI ≤ 3, 4-5, >5) was compared to age and sex-adjusted mortality in the general Swiss population. RESULTS: 863 patients (median age 81 years, 65% male, 42% with CCI > 5) were included. Peri-procedural/long-term complication rates did not differ between the low- vs. high-comorbidity groups (2.6% vs. 1.7%, p = 0.48 and 1.2% vs. 2.8%, p = 0.12, respectively). In-hospital (3.6% vs. 0.6%, p = 0.002) and all-cause mortality (HR 2.9, 95%CI 2.2-3.8, p < 0.001) were significantly higher in the high-comorbidity group resulting in a three-year mortality of 58% (95%CI 51-65%) vs. 22% (95%CI 17-27%) in the low-comorbidity group. In patients with a CCI ≤ 3, all-cause mortality was comparable to the age- and sex-adjusted mortality of the general Swiss population. CONCLUSIONS: In elderly patients with high comorbidity, LPM implantation was not associated with increased peri-procedural/long-term complications. All-cause mortality in LPM patients with a CCI ≤ 3 was comparable to age- and sex-adjusted mortality in the general Swiss population. Despite a relatively high three-year mortality due to competing risk factors, LPM implantation is safe, even in elderly patients with high comorbidity. CONDENSED ABSTRACT: In this Swiss, multi-centre, retrospective cohort analysis, 863 patients implanted with a leadless pacemaker were included and divided into a high-comorbidity (with a CCI > 5) and low-comorbidity (with a CCI ≤ 5) group. There was no between group difference in terms of implantation outcomes and peri-operative or long-term complications. Furthermore, all-cause mortality during follow-up in patients with a CCI ≤ 3 was comparable to age- and sex-adjusted mortality in the general Swiss population. These data indicate that LPM implantation is a safe procedure, even in elderly patients with high comorbidity.

Valve-in-valve transcatheter mitral valve replacement versus redo-surgical mitral valve replacement for degenerated bioprosthetic mitral valves: A systematic review and meta-analysis.

Bioprosthetic mitral valve degeneration is traditionally treated with Redo-SMVR, but the latest ViV-TMVR procedure offers a less invasive and lower risk alternative. A systematic literature search was conducted on Cochrane Central, Scopus, and Medline (PubMed interface) electronic databases from inception till 15th April 2024. We used risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes. We included a total of eleven studies with 11,931 patients in the final quantitative and qualitative analysis. When comparing ViV-TMVR with Redo-SMVR, no significant difference was found for 30-day mortality (P = 0.13) and 1-year mortality (P = 0.91), whereas patients in the ViV-TMVR showed significantly reduced incidence of stroke (P < 0.00001), In-hospital mortality (P), bleeding complications (P = 0.003), AKI (P = 0.0006), arrhythmias (P = 0.01), LVOT obstruction (P = 0.04), and PPI (P < 0.00001). Furthermore, no significant difference was observed between either group when comparing vascular complications (P = 0.97), 2-year mortality (P = 0.60) and 3-year mortality. ViV-TMVR was associated with a significant risk of paravalvular leakage (P = 0.008). Although, ViV-TMVR reduces the risk of complications associated with Redo-SMVR, larger studies are imperative to reach conclusive results.

Predictors of permanent pacemaker implantation for transcatheter self-expandable aortic valve implant in the cusp overlap era.

BACKGROUND: Predictors of permanent pacemaker implantation (PPMI) after self-expanding transcatheter aortic valve implant (TAVI) were described. Is unknown if PPMI predictors remain in the era of high implants using the cusp overlap (COP). METHODS: Single-center, prospective, consecutive case series of patients undergoing self-expanding TAVI with the COP approach. The status of PPMI and other clinical events were ascertained at 30 days. RESULTS: A total of 261 patients were included (84% with Evolut, n = 219). Implant depth >4 mm was infrequent (13.8%). TAVI depth (OR 1.259; p = 0.005), first or second-degree auriculo-ventricular block (OR 3.406; p = 0.033), right-bundle (OR 15.477; p < 0.0001), and incomplete left-bundle branch block (OR 7.964; p = 0.036) were found to be independent predictors of PPMI. The risk of PPMI with deep implant and no electrical disturbances was 3%, and 0% with high implant and no prior electrical disturbances. Those who received PPMI had no statistically significant increased risk of death, myocardial infarction, stroke, bleeding events, or vascular complications at 30 days, but longer hospital stay (mean difference 1.43 days more, p = 0.003). CONCLUSIONS: Implant depth and prior conduction abnormalities remain the main predictors of PPMI using self-expanding TAVI in the COP era. Patients with high implants and no prior conduction abnormalities may be candidates for early discharge after uneventful self-expanding TAVI, while the rest may need inpatient monitoring regardless of achieving a high implant. The need for PPMI was associated with longer hospital stays.

Total Intravenous Anesthesia Using Remimazolam for Transcarotid Approach Transcatheter Aortic Valve Replacement: A Case Report.

The transcarotid approach was introduced in Japan in April 2024 as an alternative approach for transcatheter aortic valve replacement (TAVR). Because carotid artery blood flow is reduced on one side during the procedure, there is a risk of intraoperative brain stroke. Therefore, it is crucial to check for cerebral complications immediately after the procedure. We report a case involving an 87-year-old female who underwent transcarotid TAVR under general anesthesia with remimazolam and remifentanil. The operation was completed in a short period. There was no evidence of hypotension during the induction of anesthesia, and intraoperative blood pressure control was easy. However, there was a decrease in local oxygen saturation for approximately nine minutes intraoperatively. Following the administration of flumazenil, the patient was quickly awakened, and neurological findings were confirmed to be normal. The patient was discharged without complications. Our findings suggest that remimazolam, an ultra-short-acting benzodiazepine, is feasible for the transcarotid TAVR procedure due to its minimal circulatory impact and ability to facilitate rapid and reliable arousal.

Effectiveness of a new 3D printed simulator for mitral transcatheter edge-to-edge repair in enhancing the confidence and procedural skills of the operator.

BACKGROUND: . Mitral transcatheter edge-to-edge repair (m-TEER) is a minimally invasive procedure for treating mitral regurgitation (MR). m-TEER is a highly technical procedure, and a steep learning curve needs to be overcome for operators to ensure optimal patient outcomes and minimise procedural complications. Training via online simulation and observation of procedures is not sufficient to establish operator confidence; thus, advanced hands-on training modalities need to be explored and developed. METHODS: . In this study, a novel anatomical simulator for m-TEER training was evaluated in comparison to a standard model. The proposed simulator resembled the anatomical features of the right and left atrium, left ventricle and mitral valve apparatus. Participants in the questionnaire (n = 18) were recruited across 4 centres in London with (n = 8) and without (n = 10) prior experience in m-TEER. Participants were asked to simulate procedures on both an idealised, routinely used simulator and the newly proposed anatomical model. The questionnaire was designed to assess (i) participants' confidence before and after training and (ii) the realism of the model in the context of the m-TEER procedure. The results of the questionnaires were collected, and statistical analysis (t-test) was performed. RESULTS: . Both models were equally beneficial in increasing operator confidence before and after the simulation of the intervention (P = 0.43). However, increased confidence after training with the anatomical model was recorded (P = 0.02). Participants with prior experience with m-TEER therapy were significantly more confident about the procedure after training with the anatomical model than participants who had no prior experience (P = 0.002). On average, all participants thought that the anatomical model was effective as a training simulator (P = 0.013) and should be integrated into routine training (P = 0.015)). Participants with experience thought that the anatomical model was more effective at reproducing the m-TEER procedure than the idealised model (P = 0.03). CONCLUSIONS: . This study showed how a more realistic simulator can be used to improve the effectiveness of m-TEER procedural training. Such pilot results suggest planning future and large investigations to evaluate improvements in clinical practice.

Comparing outcomes of transcatheter tricuspid valve replacement and medical therapy for symptomatic severe tricuspid regurgitation: a retrospective study.

BACKGROUND: Impaired hospitalizations for heart failure (HHF) and mortality are associated with tricuspid regurgitation (TR). OBJECTIVES: The objective of this study was to investigate the benefit of transcatheter tricuspid valve replacement (TTVR) over guideline-directed medical therapy (GDMT) in patients with symptomatic severe TR. METHODS: Between May 2020 and April 2023, 88 patients with symptomatic severe TR were treated in our center. Of these, 57 patients received GDMT alone, and 31 patients underwent combined TTVR and GDMT. We collected and analyzed baseline data, and follow-up information for both groups. The primary endpoints were all-cause mortality and the combined endpoint (including all-cause mortality and HHF). RESULTS: At a median follow-up of 20 (IQR 10-29) months, significant improvements were shown in TR severity, right ventricular function, and dimensions in TTVR group (all P < 0.001). It also resulted in superior survival rates (75.8% vs. 48.4%, P = 0.019), improved freedom from combined endpoint (61.5% vs. 45.9%, P = 0.007) and fewer major adverse events. After stratification by TRI-SCORE, the subgroup with < 6 points in the TTVR group exhibited a significant difference in the combined endpoint compared to the other subgroups (all P < 0.05), while no significant differences were observed in the GDMT subgroups (P = 0.680). CONCLUSIONS: The utilization of LuX-Valve in TTVR effectively improves TR and is associated with lower rates of major adverse events, HHF and all-cause mortality. The TRI-SCORE may help identify higher-benefit patients with TR from TTVR. Clinical trial registration ClinicalTrials.gov Protocol Registration System (NCT02917980).

A Novel Hemodynamic Index Characterizing Mitral Regurgitation Undergoing Transcatheter Edge-to-Edge Repair: The MPF.

Background: Hemodynamic impact of residual mitral regurgitation (MR) after transcatheter edge-to-edge repair (TEER) is not always univocally measured by transesophageal echocardiographic (TEE) assessment alone. When analyzing TEER procedure result, operators often encounter discrepancy between TEE guidance and invasive hemodynamic monitoring. Objectives: This study sought to investigate the role of invasive hemodynamic monitoring during mitral valve TEER procedure on top of TEE guidance. Methods: We analyzed 78 patients with moderate-to-severe or severe MR who underwent TEER. Mitral pulse pressure fraction (MPF) was extracted from intraprocedural continuous left atrial pressure monitoring. Twenty-three patients with the same grade of MR not undergoing TEER were included as a control group. At follow-up, clinical and functional status in the majority of patients undergoing TEER were reassessed by NYHA classification and the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ). Results: TEER significantly reduced MR burden on both TEE guidance and invasive hemodynamic monitoring. Post-TEER MPF was significantly reduced compared to both pre-TEER setting (P < 0.001) and control group (P < 0.001). At follow-up, while MR reduction assessed by TEE was associated with an improved functional status in terms of the 12-item KCCQ but not of NYHA classification, a greater reduction in MPF was associated with a significant amelioration of both NYHA classification (P = 0.036) and 12-item KCCQ (P = 0.032). Conclusions: MPF could provide an immediate estimate of the real hemodynamic impact of MR and a prompt prediction of the functional improvement after TEER.

Immobilized Drugs on Dual-Mode Imaging Ag2S/BaSO4/PVA Embolic Microspheres for Precise Localization, Rapid Embolization, and Local Antitumor Therapy.

Transcatheter arterial embolization (TAE) in interventional therapy and tumor embolism therapy plays a significant role. The choice of embolic materials that have good biocompatibility is an essential component of TAE. For this study, we produced a multifunctional PVA embolization material that can simultaneously encapsulate Ag2S quantum dots (Ag2S QDs) and BaSO4 nanoparticles (BaSO4 NPs), exhibiting excellent second near-infrared window (NIR-II) fluorescence imaging and X-ray imaging, breaking through the limitations of traditional embolic microsphere X-ray imaging. To improve the therapeutic effectiveness against tumors, we doped the doxorubicin (DOX) antitumor drug into microspheres and combined it with a clotting peptide (RADA16-I) on the surface of microspheres. Thus, it not only embolizes rapidly during hemostasis but also continues to release and accelerate tumor necrosis. In addition, Ag2S/BaSO4/PVA microspheres (Ag2S/BaSO4/PVA Ms) exhibited good blood compatibility and biocompatibility, and the results of embolization experiments on renal arteries in rabbits revealed good embolic effects and bimodal imaging stability. Therefore, they could serve as a promising medication delivery embolic system and an efficient biomaterial for arterial embolization. Our research work achieves the applicability of NIR-II and X-ray dual-mode images for clinical embolization in biomedical imaging.

Two-year follow-up of transcatheter aortic valve replacement in low-risk patients with symptomatic severe bicuspid aortic valve stenosis.

BACKGROUND: In 2019, the US Food and Drug Administration (FDA) approved transcatheter aortic valve replacement (TAVR) for low-risk patients with symptomatic severe tricuspid aortic stenosis. However, bicuspid aortic valve (BAV) patients were included only in single-arm registries of pivotal low-risk TAVR trials, resulting in limited data for this subgroup. METHODS: The LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and the first FDA-approved investigational device exemption trial to evaluate the feasibility of TAVR with balloon-expandable or self-expanding valves in low-risk patients with symptomatic severe BAV stenosis. This analysis reports 2-year follow-up, assessing the primary outcome of all-cause mortality and evaluating clinical outcomes. RESULTS: From 2016 to 2019, a total of 72 low-risk patients diagnosed with symptomatic, severe BAV stenosis underwent TAVR across six centers. Six patients were lost to follow-up. At 2-year follow-up, mortality was 1.5% (1 of 66 patients). Among the remaining 65 patients, four experienced nondisabling strokes (6.2%), while 2 (3.1%) developed infective endocarditis. No new permanent pacemakers were required beyond the 30-day follow-up, and no patients, including those with endocarditis, needed aortic valve re-intervention. At the 2-year echocardiography follow-up (n = 65), 27.8% of BAV patients showed mild aortic regurgitation, with none exhibiting moderate or severe regurgitation. The mean aortic gradient was 12.1 ± 4.1 mmHg, and the mean valve area was 1.7 ± 0.5 cm². CONCLUSION: The 2-year follow-up confirms commendable clinical outcomes of TAVR in patients with bicuspid aortic stenosis, establishing its evident safety.