Rate Of Major Vascular Complications Research Articles

A systematic algorithm for large-bore arterial access closure after TAVI: the TAVI-MultiCLOSE study.

Despite transcatheter aortic valve implantation (TAVI) having become a routine procedure, access site bleeding and vascular complications are still a concern which contribute to procedure-related morbidity and mortality. The TAVI-MultiCLOSE study aimed to assess the safety and efficacy of a new vascular closure algorithm for percutaneous large-bore arterial access closure following transfemoral (TF)-TAVI. All consecutive TF-TAVI cases in which the MultiCLOSE vascular closure algorithm was used were prospectively included in a multicentre, observational study. This stepwise algorithm entails the reinsertion of a 6-8 Fr sheath (primary access) following the initial preclosure with one or two suture-based vascular closure devices (VCDs). This provides the operator with the opportunity to perform a quick and easy angiographic control and tailor the final vascular closure with either an additional suture- or plug-based VCD, or neither of these. Among 630 patients who underwent TF-TAVI utilising the MultiCLOSE algorithm, complete arterial haemostasis was achieved in 616 patients (98%). VCD failure occurred in 14 patients (2%), treated with either balloon inflation (N=1), covered stent (N=12) or surgical repair (N=1). Overall, this vascular closure approach resulted in a minor and major vascular complication rate of 2.2% and 0.6%, respectively. At 30 days, only one new minor vascular complication (0.2%) was noted. In-hospital and 30-day all-cause mortality rates were 0.2% and 1.0%, respectively. Use of the MultiCLOSE vascular closure algorithm was demonstrated to contribute to an easy, safe, efficacious and durable vascular closure after TF-TAVI, resulting in a major vascular complication rate of less than 1%.

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<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

Cholesterol crystal dissolution rate of serum is associated with iliofemoral calcification and predicts outcomes in patients undergoing TAVR

Abstract Background Calcific Aortic stenosis (AS) has several findings in common with atherosclerosis including inflammation and lipoprotein deposition. Histopathological examination has revealed atherosclerotic lesions, that mainly contain cholesterol crystals (CC) in resected AS cusps. Previous studies have demonstrated that CCs can activate the NLRP3 inflammasome, resulting in an IL-1 driven systemic inflammation, that leads to the development of atherosclerotic plaques. Aims Our aim was to quantify the endogenous cholesterol crystal dissolution rate (CCDR) in AS patients undergoing TAVR. We sought to examine whether CCDR may be associated with iliofemoral calcification and suitable for identifying patients at high risk for vascular complications and increased mortality. Methods The study included 348 AS patients undergoing TAVR. Pre-interventional computed tomography (CT) scans were analyzed to quantify iliofemoral calcification from the femoral artery bifurcation to the aortic bifurcation. The CCDR was measured using flow cytometry to enumerate CC, that were added to a serum solution, at baseline and after two hours of incubation. The dissolution capacity was indicated as percentage change in CC count at baseline and after incubation. The study cohort was stratified according to the median CCDC into high and low CC dissolvers. Results The study population had a mean age of 80.9±6.2 years. CT-based calcium assessment revealed significantly higher right as well as left iliofemoral calcification in low CC dissolvers as compared to high CC dissolvers (1280 vs 1083 mm3, p=0.03; 1292 vs 1043 mm3, p=0.04, respectively). Consistently, an unplanned endovascular intervention for access-related vascular injury was needed more frequently in patients with a low CCDR, as compared to patients with a high CCDR (20.5% vs 12.2%, p=0.04), Figure 1. However, the rate of major vascular complications tended to be higher in the low CCDR group (3.4%) as compared to the high CCDR group (0.6%) but was not significantly different (p=0.12). The one-year all-cause mortality was significantly higher in patients with a low CCDR (13.6%) as compared to patients with a high CCDR (7.0%, p=0.05). This difference was mainly driven by significantly increased cardiovascular death in low CC dissolvers (9.1% vs 1.7%, p=0.03), whereas non-cardiovascular mortality rates were similar between both groups (5.1% vs 5.2%, p=0.81). In multivariate analysis, only low CCDR (OR: 2.51 [95% CI: 1.02 – 6.15], p=0.05) and Albumin (OR: 0.88 [95% CI: 0.79 – 0.98], p=0.03) were independently associated with one-year mortality following TAVR. Conclusion The CCDR is a novel biomarker associated with outcomes in AS patients undergoing TAVR. We have demonstrated, that a low CCDR is associated with increased iliofemoral calcification and vascular injury as well as one-year mortality. Thus, CCDR may provide additional prognostic information to identify vulnerable patients beyond classic risk assessment.Figure 1

Safety and efficacy of protamine administration for prevention of bleeding complications in patients with recent PCI undergoing TAVR

Abstract Background Despite major advances, TAVR is still associated with vascular and bleeding complications, that have an impact on mortality. Recent studies have shown that heparin antagonization using protamine resulted in lower bleeding rates in patients undergoing TAVR as compared to those without heparin reversal. However, there are only limited data on the safety of protamine regarding thromboembolic complications including in-stent thrombosis in TAVR patients who have had a recent PCI. Accordingly, daily practice varies between Centers. Purpose The aim of this multicentre study was to evaluate the safety and efficacy of protamine administration in patients who have had a recent PCI undergoing subsequent TAVR. Methods Our study included 1838 patients undergoing TAVI between 2017 and 2020. Of the patients included, 173 (9.4%) had a recent PCI (≤30 days), 319 (17.4%) had an intermediately (≥30 days) and 303 (16.5%) a previously performed PCI (≥6 months). Standardized vascular access management included the use of preclosure devices and PTA or implantation of a stent-graft, if necessary. The primary endpoint was a composite of one-year mortality and myocardial infarction at 30 days. Secondary endpoints included 30-day mortality and VARC-3-defined complications. Results The overall study population had a mean age of 81.1±6.2 years. Among patients with recent PCI, 134 (77.5%) patients received protamine for heparin reversal during the TAVR procedure. In the group of patients with intermediately and previously performed PCI 258 (80.9%) and 249 (82.2%) patients received protamine, respectively. In the recent PCI group, the occurrence of the primary endpoint was comparable between patients with protamine administration (24.6%) as compared to patients without heparin reversal (30.8%, p=0.53, Figure 1). Similarly, among patients with intermediately as well as previously performed PCI, the rates of the primary endpoint were comparable irrespective of protamine administration (20.1 vs 16.4%, p=0.59; 17.3 vs 27.7%, p=0.08, respectively, Figure 2). Moreover, among all three groups, the incidence of myocardial infarction at 30 days after TAVR was low and comparable between patients with and without heparin reversal (p>0.50). Overall, protamine administration was associated with decreased life-threatening bleeding (3.2 vs 9.4%, p<0.01) and major vascular complications (4.4 vs 7.9%, p=.02). Regarding safety endpoints, no overall differences were observed in the incidence of stroke between patients with and without protamine administration (1.5 vs 2.9%, p=0.13). Conclusion Protamine administration during the TAVR procedure did not increase the rate of myocardial infarction or one-year mortality in patients who have had a recently or intermediately performed PCI. Overall, heparin reversal using protamine resulted in significantly lower rates of life-threatening bleeding and major vascular complications, without increasing the incidence of stroke.Figure 1Figure 2

Vascular Complications in Transcatheter Aortic Valve Replacement With Plug-Based vs Suture-Based Closure Devices.

There are conflicting data regarding the efficacy and safety of suture vs plug-based vascular closure devices (VCDs) for large-bore catheter management in patients undergoing transcatheter aortic valve replacement (TAVR). We compared the rates of vascular complications (VCs) associated with 2 commonly used VCDs in a large cohort of patients undergoing TAVR. We conducted a single-centre, all-comer, prospective registry study, enrolling patients undergoing TAVR for symptomatic severe aortic stenosis (AS) between the years 2009 and 2022. Clinical outcomes were compared between patients undergoing closure of the femoral access point using the MANTA VCD (M-VCD) (Teleflex, Wayne, PA) vs the ProGlide VCD (P-VCD) (Abbott Vascular, Abbott Park, IL). The main outcome measures were researcher adjudicated events of VARC-2 defined major and minor VCs. Overall, 2368 patients were enrolled in the registry; 1315 (51.0% male, 81.0 ± 7.0 years) patients were included in the current analysis. P-VCD was used in 813 patients, whereas M-VCD was used in 502 patients. In-hospital VCs were more frequent in the M-VCD vs the P-VCD group (17.3% vs 9.8%; P < 0.001). This outcome was mainly driven by elevated rates of minor VCs in the M-VCD group, whereas no significant difference was observed for major VCs (15.1% vs 8.4%; P < 0.001 and 2.2% vs 1.5%; P= 0.33, respectively). In patients undergoing TAVR for severe AS, M-VCD was associated with higher rates of VCs. This outcome was mainly driven by minor VCs. The rate of major VCs was low in both groups.

Association Between Polyvascular Disease and Transcatheter Aortic Valve Replacement Outcomes: Insights From the STS/ACC TVT Registry.

Atherosclerotic cardiovascular disease is highly prevalent in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). Polyvascular disease (PVD), defined as involvement of ≥2 vascular beds (VBs), that is, coronary, cerebrovascular, or peripheral, portends a poor prognosis in patients with atherosclerotic cardiovascular disease; however, data on the association of PVD with outcomes of patients undergoing TAVR are limited. The Society of Thoracic Surgeons and the American College of Cardiology Transcatheter Valve Therapy Registry was analyzed to identify patients who underwent TAVR from November 2011 to March 2022. The exposure of interest was PVD. The primary outcome was all-cause mortality. Secondary outcomes included major vascular complications, major/life-threatening bleeding, myocardial infarction, transient ischemic attack/stroke, and valve- and non-valve-related readmissions. Outcomes were assessed at 30 days and 1 year. Of 443 790 patients who underwent TAVR, PVD was present in 150 823 (34.0%; 111 425 [25.1%] with 2VB-PVD and 39 398 [8.9%] with 3VB-PVD). On multivariable analysis, PVD was associated with increased all-cause mortality at 1 year (hazard ratio, 1.17 [95% CI, 1.14-1.20]). There was an incremental increase in 1-year mortality with an increasing number of VBs involved (no PVD [reference]; 2VB-PVD: hazard ratio, 1.12 [95% CI, 1.09-1.15]: and 3VB-PVD: hazard ratio, 1.31 [95% CI, 1.26-1.36]). Patients with versus without PVD had higher rates of major vascular complications, major/life-threatening bleeding, transient ischemic attack/stroke, and non-valve-related readmissions at 30 days and 1 year. PVD is associated with worse outcomes after TAVR, and the risk is highest in patients with 3VB-PVD.

Sex-Related Differences in Patient Characteristics, Hemodynamics, and Outcomes of Cardiogenic Shock: INOVA-SHOCK Registry.

Little is known about sex-related differences in outcomes of patients with cardiogenic shock (CS) treated within a standardized team-based approach (STBA). We evaluated 520 consecutive patients (151 women and 369 men) with CS due to acute myocardial infarction (AMI) and heart failure (HF) in a single-center registry (January 2017-December 2019) and examined outcomes according to sex and CS phenotype. The primary outcome was in-hospital mortality. Secondary outcomes included major adverse cardiac events, 30-day mortality, major bleeding, vascular complications, and stroke. Women with AMI-CS had higher baseline acuity (CardShock score: female [F]: 5.5 vs male [M]: 4.0; P = .04). Women with HF-CS more often presented with cardiac arrest (F: 12.4% vs M: 2.4%; P< .01) and had higher rates of vasopressor use (F: 70.8% vs M: 58.0%; P = .04) and mechanical circulatory support (F: 46.1% vs M: 32.5%; P = .04). There were no sex-related differences in in-hospital mortality for AMI-CS (F: 45.2% vs M: 36.9%; P = .28) and HF-CS (F: 28.1% vs M: 24.5%; P = .56). Women with HF-CS experienced higher rates of major bleeding (F: 25.8% vs M: 13.7%; P = .02) and vascular complications (F: 15.7% vs M: 6.1%; P = .01). However, female sex was not an independent predictor of these complications. No sex differences in survival were noted at 1 year. Within an STBA, although women with AMI-CS and HF-CS presented with higher acuity, they experienced similar in-hospital mortality, major adverse cardiac events, 30-day mortality, stroke, and 30-day readmissions as men. Further research is needed to better understand the extent to which historical differences in CS outcomes can be mitigated by an STBA.

Systematic Review and Meta-analysis of Radial or Femoral Access for Carotid Stenting.

There is agrowing interest in performing coronary artery and neurovascular interventions via the radial artery; however, few studies have examined the outcomes of transradial carotid stenting. Therefore, our study aimed to compare cerebrovascular outcomes and crossover rates in carotid stenting between transradial and traditional transfemoral approaches. Asystematic review was performed by searching three electronic databases from inception to June 2022 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. In addition, random effect meta-analysis was used to pool the odds ratios (ORs) for stroke, transient ischemic attack, major adverse cardiac events, death, major vascular access site complications, and procedure crossover rates between the transradial and transfemoral approaches. A total of 6 studies were included involving a total of n = 567transradial and n = 6176transfemoral procedures. The ORs for stroke, transient ischemic attack, and major adverse cardiac events were 1.43 (95% confidence interval, CI 0.72-2.86, I2 = 0), 0.51 (95% CI 0.17-1.54, I2 = 0), and 1.08 (95% CI 0.62-1.86, I2 = 0), respectively. Neither the major vascular access site complication rate (OR 1.11, 95% CI 0.32-3.87, I2 = 0) nor crossover rate (OR 3.94, 95% CI 0.62-25.11, I2 = 57%) showed statistically significant differences between the two approaches. The modest quality of the data suggested comparable procedural outcomes between the transradial and transfemoral approaches when performing carotid stenting; however, high level evidence regarding postoperative brain images and risk of stroke in transradial carotid stenting are lacking. Therefore, it is reasonable for interventionists to weigh up the risks of neurological events and potential benefits, including fewer access site complications, before choosing the radial or femoral arteries as access sites. Future large-scale randomized controlled trials are imperative.

Impact of transradial versus transfemoral access for preprocedural coronary angiography on TAVR-associated complications

Vascular injury and bleeding complications remain frequent after transcatheter aortic valve replacement (TAVR). Whether the access-site of preprocedural coronary angiography (CAG) affects TAVR-related complications is not known. The aim of this study was to evaluate the impact of transradial (TRA) versus transfemoral access (TFA) for preprocedural CAG on outcomes in patients undergoing subsequent TAVR. The study cohort included 1002 patients undergoing transfemoral TAVR, of whom 39.4% (395/1002) had undergone radial and 60.6% (607/1002) femoral access for pre-TAVR CAG. The primary endpoint was a composite of 30-day mortality and major vascular complications after TAVR. Key secondary endpoints included VARC-3-defined complications. The primary endpoint occurred less frequently in patients with prior TRA (3.3%) as compared to patients with prior TFA (6.3%, p=0.04), which was mainly driven by significantly lower rates of major vascular complications (0.8% vs 2.5%, p=0.05). Moreover, incidences of periprocedural access-related vascular injury and unplanned endovascular interventions were lower in TRA patients (13.2% vs 18.0%, p=0.05). The rate of major bleeding tended to be lower in the TRA (1.5%) as compared to the TFA group (3.5%) but was not significantly different (p=0.07). Moreover, the rate of life-threatening bleeding was comparable between both groups (0.5% vs 0.8%, p=0.71). Transradial access for preprocedural CAG was associated with significantly lower rates of vascular complications following subsequent TAVR as compared to transfemoral access. However, despite the tendency to lower major bleedings with transradial access, no significant association was detectable between the access-site of coronary angiography and TAVR-related bleeding complications.

QI-452785-4 DURING CARDIAC ELECTROPHYSIOLOGY PROCEDURES ULTRASOUND GUIDANCE OF VENOUS PUNCTURE REDUCES MAJOR AND TOTAL VASCULAR COMPLICATIONS - A META-ANALYSIS

Puncture site vascular complications (VCs) are the most common complications of invasive electrophysiology (EP) procedures. The use of vascular ultrasound during puncture is already included in the guidelines of other medical fields, e.g. intensive care, and also widely used in EP labs around the world, but not yet standard practice in all of them. Our aim was to conduct a meta-analysis which compares anatomical guidance to the use of ultrasound during the femoral venous puncture in conjunction with electrophysiology procedures. In contrast to the previous meta-analyses, we aimed to use a uniform endpoint and to involve new publications to improve patients numbers. In order to find articles which report, both with and without ultrasound guidance, the rate of vascular complications during EP procedures, a systematic search was performed in the relevant electronic databases. Major VCs (MVCs), as defined in the 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus) were the primary endpoint. AV-fistula, pseudoanerurysm and major bleeding (each separately), minor VCs, total VCs and inadvertent arterial punctures were defined as secondary endpoints, For statistical analysis we used a random effects model with the Mantel-Haenszel method. Data on 23605 patients was reported by the 14 articles matching our selection criteria. The primary outcome was reported on 13050 of them (in 10 articles), with 200 (156 %) reaching the primary endpoint of an MVC. The occurrence of MVCs was significantly reduced by the routine use of ultrasound during the puncture (29/4542 vs. 171/8508, OR 0.22 [0.10-0.50], p<0.001). Moreover, the incidence of several secondary endpoints was also significantly lower: total vascular complications – OR 0.27 [0.13-0.53] (p<0.001), minor vascular complications: OR 0.25 [0.16-0.74], accidental artery puncture – OR was 0.20 [0.09-0.41] (p<0.001). There was insufficient data reported regarding AV-fistula, pseudoanerurysm and major bleeding specifically. While using a more uniform MVC definition compared to previous meta-analyses and covering more than 1.5 times as many patients, we demonstrated that ultrasound guidance for femoral venous puncture during EP procedures is significantly beneficial. Above all, the rate of MVCs and total VCs is reduced by this technique. These results show that its routine use should be considered in every EP lab and this could bring important improvements in patient safety.

PO-05-068 MAJOR VASCULAR COMPLICATIONS IN A LARGE COHORT OF PATIENTS UNDERGOING CATHETER ABLATION FOR VPB/VT IN A HIGH-VOLUME, TERTIARY EP CENTER

Catheter ablation is an established treatment method both in patients with idiopathic premature ventricular complexes (PVC) or ventricular tachycardia (VT) and in structural heart disease (SHD) VT. Major vascular complications (MVCs) are the most frequent in these populations. A retrospective study investigating the incidence of MVCs in large-volume, specialized VT center and analyzing their predictors. We included PVC/VT patients who had their first ablation procedure between August 2006 - December 2020. The procedures were performed under conscious sedation except for patients who were on mechanical ventilation because of hemodynamical or electrical instabilit. Activation mapping supported by an electroanatomic mapping system was used in idiopathic cases. In SHD, substrate mapping using an electroanatomic mapping system and pacemapping was employed as a prerequisite for complete substrate modification during spontaneous rhythm or pacing. Activation and entrainment mapping for well-tolerated VTs were rarely used. The goal of ablation was to abolish all inducible VTs. A specific institutional tracking system for complications of invasive procedures was used to collect all periprocedural complications that were subsequently adjudicated. MVCs were defined as those that result in permanent injury or death, require intervention or treatment, prolong hospitalization (>48 hrs) or require new hospitalization. Idiopathic PVC/VT ablation was performed in 656 pts (males: 50%, age: 51 ± 17 years, re-ablations: 15%). SHD VT was ablated in 1637 pts (males: 88%, age: 63 ± 13 years, re-ablations: 30%, ischemic cardiomyopathy: 65%, left ventricular ejection fraction: 34 ± 13%, electrical storm: 24%). In idiopathic PVC/VT, MVCs were observed in 2.4 % (4.0% in males vs. 0.9% in females, P <0.01). In SHD, the rate of MVCs reached 3.5 % (2.8% in males vs. 9.4% in females, P <0.00001). Based on the multivariable regression model, the composite risk score to predict MVCs was proposed that was calculated as a sum of risk points for age (0, 1, 2, and 3 points for <50, 50–59, 60–69, and ≥70 years, respectively), female gender (2 points), and serum creatinine >1.3mg/dL (2 points), range 0–7 (Figure). While in an idiopathic setting, MVCs were more frequent in males, which may reflect a higher proportion of more complex LV ablations and arterial access, there was a significant female predominance in MVCs in SHD. The composite risk score predicts the risk of MVCs independently of VT cause.

Vascular access for transcatheter aortic valve replacement: A network meta-analysis

BackgroundThe choice of an alternative access for transcatheter aortic valve replacement (TAVR) remains controversial when transfemoral (TF) access is not feasible. MethodsWe conducted a network meta-analysis to compare the outcomes of TAVR via various peripheral vascular accesses. MEDLINE and EMBASE were searched through July 2022 to identify studies that investigated outcomes in patients who underwent TAVR via TF, trans-subclavian (Tsc), transcarotid (TC), or transcaval (Tcav) access. A network meta-analysis was conducted via random-effects model. Outcomes of interest were major or life-threatening bleeding, stroke, major vascular complication, and 30-day mortality. ResultsNo randomized trial was identified. Our analysis included 33 observational studies that enrolled a total of 43,455 patients who underwent TAVR via TF (n = 36,202), Tsc (n = 3869), TC (n = 3066), or Tcav (n = 318) access. The risk of major or life-threatening bleeding was higher via Tsc compared with TF [odds ratio (OR); 95 % confidence interval (CI) =1.51 (1.03–2.23), p = 0.034]. The risk of stroke was higher via Tsc compared with TF and Tcav [OR (95 % CI) =2.00 (1.14–3.52), p = 0.018, OR (95 % CI) =2.43 (1.03–5.74), p = 0.044, respectively]. The risk of major vascular complications was lower via TC compared with Tsc, and Tcav and higher with Tcav compared with TF and Tsc. 30-day mortality was higher via Tsc compared with TF. Tsc was associated with higher risk of major or life-threatening bleeding compared with TF, and higher risk of stroke compared to TF and Tcav. Tcav had the highest risk of major vascular complications. ConclusionIn patients who underwent TF, Tsc, TC, or Tcav TAVR, Tsc had a higher rate of stroke compared to TF and Tcav, and major or life-threatening bleeding compared to TF. The rate of major vascular complications in Tcav was the highest among the four approaches.

Transcatheter Aortic Valve Implantation Outcomes and Challenges in Asia: A Systematic Review and Meta-Analysis

Background: Aortic stenosis (AS) is the world’s most prevalent heart valve disease. Transcatheter aortic valve replacement (TAVR) or Implantation (TAVI) is widely available yet adopting this procedure in Asia has been slow due to high device cost, the need for specific training programs, and the lack of specialized heart teams and dedicated infrastructures. The limited number of randomized controlled trials describing TAVI outcomes among the Asian population hampered the approval for medical reimbursements as well as acceptance among surgeons and operators in some Asian countries. Methods: A comprehensive medical literature search on TAVI and/or TAVR performed in Asian countries published between January 2015 and June 2022 was done through MEDLINE and manual searches of bibliographies. The full text of eligible articles was obtained and evaluated for final analysis. The event rates for key efficacy and safety outcomes were calculated using the data from the registries and randomized controlled trials. Results: A total of 15,297 patients were included from 20 eligible studies. The mean patient age was 82.88 ± 9.94 years, with over half being females (62.01%). All but one study reported Society of Thoracic Surgeons (STS) scores averaging an intermediate risk score of 6.28 ± 1.06%. The mean logistic European Systems for Cardiac Operations Risk Evaluation (EuroSCORE) was 14.85. The mean baseline transaortic gradient and mean aortic valve area were 50.93 ± 3.70 mmHg and 0.64 ± 0.07 cm2, respectively. The mean procedural success rate was 95.28 ± 1.51%. The weighted mean 30-day and 1-year all-cause mortality rate was 1.66 ± 1.21% and 8.79 ± 2.3%, respectively. The mean average for stroke was 1.98 ± 1.49%. The acute kidney injury (AKI) rate was 6.88 ± 5.71%. The overall major vascular complication rate was 2.58 ± 2.54%; the overall major bleeding rate was 3.88 ± 3.74%. Paravalvular aortic regurgitation rate was 15.07 ± 9.58%. The overall rate of pacemaker insertion was 7.76 ± 4.6%. Conclusions: Compared to Americans and Europeans, Asian patients who underwent TAVI had lower all-cause mortality, bleeding, and vascular complications, however, had a higher rate of postprocedural aortic regurgitation. More studies with greater sample sizes are needed among Asian patients for a more robust comparison.

Long-term mortality after transcatheter aortic valve implantation for aortic stenosis in immunosuppression-treated patients: a propensity-matched multicentre retrospective registry-based analysis.

Data regarding patients with a previous medical record of immunosuppression treatment who have undergone transcatheter aortic valve implantation (TAVI) are limited and extremely inconclusive. Available studies are mostly short term observations; thus there is a lack of evidence on efficacy and safety of TAVI in this specific group of patients. To compare the in-hospital and long-term outcomes between patients with or without a medical history of immunosuppressive treatment undergoing TAVI for aortic valve stenosis (AS). We conducted a retrospective registry-based analysis including patients undergoing TAVI for AS at 5 centres between January 2009 and August 2017. The primary endpoint was long-term all-cause mortality. Secondary endpoints comprised major vascular complications, life-threatening or disabling bleeding, stroke and new pacemaker implantation. Of 1451 consecutive patients who underwent TAVI, two propensity-matched groups including 25 patients with a history of immunosuppression and 75 patients without it were analysed. No differences between groups in all-cause mortality were found in a median follow-up time of 2.7 years following TAVI (p = 0.465; HR = 0.73; 95% CI: 0.30-1.77). The rate of major vascular complications (4.0% vs. 5.3%) was similar in the two groups (p = 1.000). There were no statistically significant differences in the composite endpoint combining life-threatening or disabling bleeding, major vascular complications, stroke and new pacemaker implantation (40.0% vs. 20.0%, p = 0.218). Patients who had undergone TAVI for AS had similar long-term mortality regardless of whether they had a previous medical record of immunosuppression. Procedural complication rates were comparable between the groups.

The Influence of the Learning Curve on Clinical Outcomes in Balloon-Expandable versus Self-Expandable Transfemoral Transcatheter Aortic Valve Implantation.

Balloon-expandable (BE) and self-expandable (SE) prostheses are the main types of devices currently used in transcatheter aortic valve implantation (TAVI). Despite the different designs, clinical practice guidelines do not make any specific recommendation on the selection of one device over the other. Most operators are trained in using both BE and SE prostheses, but operator experience with each of the two designs might influence patient outcomes. The aim of this study was to compare the immediate and mid-term clinical outcomes during the learning curve in BE versus SE TAVI. The transfemoral TAVI procedures performed in a single center between July 2017 and March 2021 were grouped according to the type of implanted prosthesis. The procedures in each group were ordered according to the case sequence number. For each patient, a minimum follow-up time of 12 months was required for inclusion in the analysis. The outcomes of the BE TAVI procedures were compared with the outcomes of the SE TAVI procedures. Clinical endpoints were defined according to the Valve Academic Research Consortium 3 (VARC-3). The median follow-up time was 28 months. Each device group included 128 patients. In the BE group, case sequence number predicted mid-term all-cause mortality at an optimal cutoff value ≤58 procedures (AUC 0.730; 95% CI: 0.644-0.805; p &lt; 0.001), while in the SE group, the cutoff value was ≤85 procedures (AUC 0.625; 95% CI: 0.535-0.710; p = 0.04). A direct comparison of the AUC showed that case sequence number was equally adequate in predicting mid-term mortality, irrespective of prosthesis type (p = 0.11). A low case sequence number was associated with an increased rate of VARC-3 major cardiac and vascular complications (OR 0.98 95% CI: 0.96-0.99; p = 0.03) in the BE device group, and with an increased rate of post-TAVI aortic regurgitation ≥ grade II (OR 0.98; 95% CI: 0.97-0.99; p = 0.03) in the SE device group. In transfemoral TAVI, case sequence number influenced mid-term mortality irrespective of prosthesis type, but the learning curve was longer in the case of SE devices.

Abstract 12367: Tavr Outcomes in Overweight and Obese Patients: Systematic Review and Meta-Analysis

Introduction: In recent years, the “obesity paradox” has been shown in studies demonstrating better outcomes in overweight and obese patients undergoing percutaneous or surgical cardiovascular procedures. This study compares the effect of body-mass index (BMI) on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). Methods: A comprehensive systematic search was conducted in PubMed, Web of Science, and Cochrane library for relevant studies. Studies were included if they had categories for BMI (normal-weight, overweight, and obese) and reported the outcomes of TAVR in each group. Random-effects using STATA was performed for the meta-analysis. Results: 34 studies with 96,093 patients were included in our study. Overweight and obese patients had a significantly lower rate of 1-year all-cause mortality, long-term all-cause mortality and moderate to severe aortic regurgitation compared to normal-weight patients (Figure 1). Incidence of 30-day myocardial infarction was lower in overweight patients, and 1-year stroke incidence was significantly lower in obese patients compared with normal cases. In contrast, permanent pacemaker implantation was more observed in overweight and obese patients. There was no significant difference in outcomes in underweight patients compared to normal-weight ones except for a higher rate of major vascular complications in underweight cases. Conclusions: Our analysis showed improved outcomes in terms of all-cause mortality and aortic regurgitation in overweight and obese patients undergoing TAVR compared to normal-weight patients.

Early and mid-term outcome of patients with low-flow-low-gradient aortic stenosis treated with newer-generation transcatheter aortic valves.

Patients with non-paradoxical low-flow–low-gradient (LFLG) aortic stenosis (AS) are at increased surgical risk, and thus, they may particularly benefit from transcatheter aortic valve replacement (TAVR). However, data on this issue are still limited and based on the results with older-generation transcatheter heart valves (THVs). The aim of this study was to investigate early and mid-term outcome of TAVR with newer-generation THVs in the setting of LFLG AS. Data for the present analysis were gathered from the OBSERVANT II dataset, a national Italian observational, prospective, multicenter cohort study that enrolled 2,989 consecutive AS patients who underwent TAVR at 30 Italian centers between December 2016 and September 2018, using newer-generation THVs. Overall, 420 patients with LVEF ≤50% and mean aortic gradient <40 mmHg were included in this analysis. The primary outcomes were 1-year all-cause mortality and a combined endpoint including all-cause mortality and hospital readmission due to congestive heart failure (CHF) at 1 year. A risk-adjusted analysis was performed to compare the outcome of LFLG AS patients treated with TAVR (n = 389) with those who underwent surgical aortic valve replacement (SAVR, n = 401) from the OBSERVANT I study. Patients with LFLG AS undergoing TAVR were old (mean age, 80.8 ± 6.7 years) and with increased operative risk (mean EuroSCORE II, 11.5 ± 10.2%). VARC-3 device success was 83.3% with 7.6% of moderate/severe paravalvular leak. Thirty-day mortality was 3.1%. One-year all-cause mortality was 17.4%, and the composite endpoint was 34.8%. Chronic obstructive pulmonary disease (HR 1.78) and EuroSCORE II (HR 1.02) were independent predictors of 1-year mortality, while diabetes (HR 1.53) and class NYHA IV (HR 2.38) were independent predictors of 1-year mortality or CHF. Compared with LFLG AS treated with SAVR, TAVR patients had a higher rate of major vascular complications and permanent pacemaker, while SAVR patients underwent more frequently to blood transfusion, cardiogenic shock, AKI, and MI. However, 30-day and 1-year outcomes were similar between groups. Patients with non-paradoxical LFLG AS treated by TAVR were older and with higher surgical risk compared with SAVR patients. Notwithstanding, TAVR was safe and effective with a similar outcome to SAVR at both early and mid-term.

Routine Ultrasonography Guidance for Femoral Vascular Access for Cardiac Procedures

A significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared with radial access. Strategies to make femoral access safer are needed. To determine whether routinely using ultrasonography guidance for femoral arterial access for coronary angiography/intervention reduces bleeding or vascular complications. The Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures (UNIVERSAL) randomized clinical trial is a multicenter, prospective, open-label trial of ultrasonography-guided femoral access vs no ultrasonography for coronary angiography or intervention with planned femoral access. Patients were randomized from June 26, 2018, to April 26, 2022. Patients with ST-elevation myocardial infarction were not eligible. Ultrasonography guidance vs no ultrasonography guidance for femoral arterial access on a background of fluoroscopic landmarking. The primary composite outcome is the composite of major bleeding based on the Bleeding Academic Research Consortium 2, 3, or 5 criteria or major vascular complications within 30 days. A total of 621 patients were randomized at 2 centers in Canada (mean [SD] age, 71 [10.24] years; 158 [25.4%] female). The primary outcome occurred in 40 of 311 patients (12.9%) in the ultrasonography group vs 50 of 310 patients (16.1%) without ultrasonography (odds ratio, 0.77 [95% CI, 0.49-1.20]; P = .25). The rates of Bleeding Academic Research Consortium 2, 3, or 5 bleeding were 10.0% (31 of 311) vs 10.7% (33 of 310) (odds ratio, 0.93 [95% CI, 0.55-1.56]; P = .78). The rates of major vascular complications were 6.4% (20 of 311) vs 9.4% (29 of 310) (odds ratio, 0.67 [95% CI, 0.37-1.20]; P = .18). Ultrasonography improved first-pass success (277 of 311 [86.6%] vs 222 of 310 [70.0%]; odds ratio, 2.76 [95% CI, 1.85-4.12]; P < .001) and reduced the number of arterial puncture attempts (mean [SD], 1.2 [0.5] vs 1.4 [0.8]; mean difference, -0.26 [95% CI, -0.37 to -0.16]; P < .001) and venipuncture (10 of 311 [3.1%] vs 37 of 310 [11.7%]; odds ratio, 0.24 [95% CI, 0.12-0.50]; P < .001) with similar times to access (mean [SD], 114 [185] vs 129 [206] seconds; mean difference, -15.1 [95% CI, -45.9 to 15.8]; P = .34). All prerandomization prespecified subgroups were consistent with the overall finding. In this randomized clinical trial, use of ultrasonography for femoral access did not reduce bleeding or vascular complications. However, ultrasonography did reduce the risk of venipuncture and number of attempts. Larger trials may be required to demonstrate additional potential benefits of ultrasonography-guided access. ClinicalTrials.gov Identifier: NCT03537118.

Selection of Vascular Closure Devices in Transcatheter Aortic Valve Replacement: Systematic Review and Network Meta-Analysis

Various vascular closure devices (VCDs) are commonly used for percutaneous transcatheter aortic valve replacement (TAVR). However, superiority and safety profile among them remain unclear. We compared periprocedural complications among various VCDs in patients undergoing TAVR. PubMed and EMBASE were searched through January 2022 to identify clinical studies comparing any 2 VCDs of Prostar, Proglide and MANTA in patients who underwent TAVR. Studies using surgical cut-down or alternative access other than transfemoral approach were excluded. We analyzed the odds ratios (ORs) of vascular complications (VC), bleeding, acute kidney injury and all-cause mortality using a network meta-analysis. All outcomes were defined by Valve Academic Research Consortium 2 criteria. Two randomized controlled trials and 15 observational studies were identified, yielding a total of 11,344 patients including Prostar (n = 4499), Proglide (n = 5705), or MANTA group (n = 1140). The rates of major VC and life-threatening and major bleeding were significantly lower in Proglide compared to Prostar (OR [95 % CI] = 0.54 [0.32–0.89], 0.68 [0.52–0.90], and 0.49 [0.26–0.95], respectively). There was no significant difference in major VC and bleeding between Proglide and MANTA groups. Proglide was associated with a lower rate of acute kidney injury (0.56 [0.34–0.92]) and red blood cell transfusion (0.39 [0.16–0.98]) compared to Prostar. There was no significant difference in additional interventions and 30-day overall mortality among three groups. In this network meta-analysis of VCD in patients undergoing TAVR, MANTA and Proglide had comparable outcomes while Proglide appears superior to Prostar in terms of major VC and bleeding.

Transcatheter aortic valve implantation in patients with uninterrupted vitamin K antagonists.

Bridging of vitamin K antagonist (VKA) with heparin is usually not promoted during interventional or surgical procedures related to increased risk of bleeding and thrombotic events but this strategy has not been evaluated during transcatheter aortic valve implantation (TAVI). The aim of this study was to evaluate the rate of major bleeding and vascular complications after TAVI performed in patients with uninterrupted VKA. From January 2016 to October 2017, consecutive patients who underwent TAVI with uninterrupted VKA (International Normalized Ratio [INR]between 1.5 and 3.5) were prospectively included in a monocentric registry. TAVI was performed according to current guidelines and a 50 U/kgbolus of heparin was injected at the beginning of the procedure for all patients. Vascular and bleeding complications were assessed using the Valve Academic Research Consortium 3 (VARC3) and the Bleeding Academic Research Consortium (BARC) definitions at a 30-day follow-up. A total of 88 patients were included with a median age of 84 years (81.8-87.0), 42% being female. The median society of thoracic surgeons score was 5.1 (4.1-7.5), the median CHADS2-VAScwas 5.5 (5-6)and 60.2% had a chronic kidney failure. Median INR at the time of implantation was 2.1 (1.8-2.6). The main VKA indication was atrial fibrillation. Transfemoral access was used in 88.6% of the patients. Major bleeding (BARC ≥ 3b) occurred in five patients (5.7%) and major vascular complications occurred in seven patients (8.0%). At 1month follow-up, major bleeding (BARC ≥ 3) or vascular complications occurred in 10 patients (11.4%). In patients with major bleeding peripheral arterial disease (RR = 10.95; 95% confidence interval (CI) 1.63-73.75; p = 0.014) and carotid access (RR = 8.56; 95% CI 1.19-1.51; p = 0.033) were more common. INR > 2.5 was significantly associated with vascular complications (RR = 7.14; 95% CI 1.29-39.63; p = 0.025). At 30 days, mortality and stroke rates were 2.3% and 4.5%, respectively. TAVI with uninterrupted VKA treatment seems feasible and safe with a low risk of major bleeding and vascular complications in this first single-center experience. Particular caution is advocated in high body mass index patients and to keep INR < 2.5.