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

Objectives: The authors compared the risk of cerebrovascular events (CVE) with self-expanding vales (SEV) vs balloon-expandable valves (BEV) in patients with or without peripheral artery disease (PAD), stratified by the access route and the complexity of PAD (Hostile score)., Methods: The PAD-related risk of CVE between SEV vs BEV was investigated using data from the HOSTILE Registry, an observational study including 1707 patients with severe PAD undergoing transcatheter aortic valve replacement (TAVR) via different access routes. The relative risk of CVE with SEV vs BEV in patients without PAD was investigated in a meta-analysis of randomized controlled transfemoral access (TFA)-TAVR trials of patients with normal femoral arteries. The primary endpoint was the risk of 30-day CVE., Results: Among the 1021 patients undergoing TAVR through TFA or transaxillary access (TAxA), 674 (66.0%) received SEVs and 329 (32.2%) received BEVs. The 30-day propensity-adjusted risk of CVE was higher for SEV compared with BEV (adjusted hazard ratio [HR], 2.70; 95% CI, 1.16-6.23), with no significant interaction between the transcatheter heart valve and either the access route or the Hostile score. Similar results were apparent at 1 year (adjusted HR, 2.98; 95% CI, 1.30-6.83). In contrast, in a meta-analysis of 4 RCTs and 2131 patients with femoral arteries suitable for TAVR, there were no significant differences in the 30-day rates of CVE between SEV and BEV (odds ratio, 0.58; 95% CI, 0.24-1.40)., Conclusions: Compared with BEVs, SEVs were associated with higher 30-day and 1-year rates of CVE in patients with PAD, a finding not apparent in patients with suitable femoral arteries enrolled in RCTs.

Background: Mitral valve transcatheter edge-to-edge repair (M-TEER) has emerged as a viable therapy option in patients with severe mitral regurgitation and high surgical risk. Although atrial fibrillation is common among patients undergoing M-TEER, the optimal anticoagulatory treatment after the intervention is unknown., Methods: A single-center retrospective observational analysis was conducted using data from the M-TEER registry at the University Hospital Cologne collected from 2019 untill 2021 including patients undergoing M-TEER between November 2012 and April 2019. Patients with atrial fibrillation receiving consistent anticoagulation following M-TEER were categorized into a direct oral anticoagulant or a vitamin K antagonist (VKA) group. The primary end point was a composite of ischemic cerebrovascular and bleeding events. Additionally, overall survival was assessed., Results: Among 613 patients undergoing M-TEER, 206 met the inclusion criteria, with 61 receiving direct oral anticoagulants and 145 receiving VKAs. After a median follow-up of 833 (interquartile range, 355-1271) days, the incidence of the composite primary end point did not differ between direct oral anticoagulant and VKA groups (hazard ratio [HR], 0.51 [95% CI, 0.23-1.12]; P =0.07). Similarly, rates of ischemic cerebrovascular events and bleeding events were similar between groups. However, the overall mortality rate was higher in the VKA group (HR, 2.56 [95% CI, 1.54-4.26]; P =0.002). In the multivariable analysis, oral anticoagulation with a VKA was an independent predictor for death (adjusted HR, 2.23 [95% CI, 1.08-5.06]; P =0.03)., Conclusions: Our findings suggest that direct oral anticoagulants may offer comparable efficacy and safety to VKAs in preventing thromboembolic events following M-TEER in patients with atrial fibrillation. Further randomized trials are needed to confirm these results and establish optimal anticoagulation strategies in this patient population.

Background: Patients with ST-segment elevation myocardial infarction (STEMI) are often pretreated with unfractionated heparin (UFH) before a primary percutaneous coronary intervention (PPCI). UFH pretreatment is intended to lessen the thrombotic burden, but there have been conflicting study findings on its safety and efficacy. We assessed the risks and benefits of UFH pretreatment with a retrospective analysis of registry data from the STEMI network of a German metropolitan region., Methods: Data from patients with STEMI referred for PPCI from 2005 to 2020 were evaluated with an adjusted outcome analysis, including propensity score matching (PSM). The endpoints included the patency of the infarct-related artery (IRA) after PPCI, in-hospital mortality, access-site bleeding, and the peak creatine kinase (CK) level., Results: We assessed data from 4632 patients with STEMI: 4420 (95.4%) were pretreated with UFH, and 212 (4.6%) were not. After PSM of 511 vs. 187 patients, the adjusted odds ratios for the various endpoints were (pretreatment vs. no pretreatment, with 95% confidence intervals): for impaired flow of the IRA, 1.01 [0.59; 1.74]; for in-hospital mortality, 1.46 [0.88; 2.42]; and for access-site bleeding, 0.59 [0.14; 2.46]. The peak creatine kinase levels were similar in the two groups (median, 1248.0 vs. 1376.5 U/L, estimated difference -134 [-611; 341])., Conclusion: UFH pretreatment was less frequently performed in STEMI patients who had undergone cardiopulmonary resuscitation. UFH pretreatment was not associated with increased access-site bleeding, nor was it found to have significantly higher efficacy with respect to the relevant endpoints. The risks and benefits of UFH pretreatment should be weighed individually in each case, as evidence from high-quality clinical trials is lacking. Data from the existing literature suggest that no pretreatment is an option to be considered, as are certain alternative antithrombotic strategies.

Background: Guidelines on myocardial infarction (MI) recommend antithrombotic and anticoagulatory treatment at time of diagnosis. MI with ST segment elevation (STEMI) is mostly a certain diagnosis. Acute coronary syndrome without ST segment elevation (NSTE-ACS) has diagnostic uncertainty and remains a working diagnosis in the prehospital setting., Objective: Assessment of prehospital loading with aspirin and heparin depending on ACS subtype and pretreatment with oral anticoagulants., Methods: The PRELOAD survey was a nationwide German study. STEMI/NSTE-ACS scenarios were designed and varied in pretreatment: I) no pretreatment, II) new oral anticoagulants (NOAC), III) vitamin K antagonist (VKA). Loading strategy was assessed and included: a) aspirin (ASA), b) unfractionated heparin (UFH), c) ASA + UFH, d) no loading., Results: A total of 708 emergency physicians were included. In NSTE-ACS without pretreatment, 79% chose loading (p < 0.001). ASA + UFH (71.4%) was the preferred option. In corresponding STEMI scenario, 100% chose loading and 98.6% preferred ASA + UFH (p < 0.001). In NSTE-ACS with NOAC pretreatment, 69.8% favored loading (p < 0.001); in VKA pretreatment the corresponding rate was 72.3% (p < 0.001). In each scenario, ASA was the preferred option. In STEMI with NOAC pretreatment, 97.5% chose loading (p < 0.001); analogous rate was 96.8% in STEMI with VKA pretreatment (p < 0.001). ASA was the preferred option again., Conclusions: Prehospital loading was the preferred treatment strategy despite the diagnostic uncertainty in NSTE-ACS and guidelines recommending loading at time of diagnosis. Pretreatment with oral anticoagulants resulted in a strategy shift to loading with only aspirin. In STEMI patients, this indicates potential undertreatment., (© 2023. The Author(s).)

Background: Left ventricular thrombus (LVT) is associated with high rates of systemic embolism. Vitamin K antagonists (VKAs) are the only approved treatment for LVT. Although evidence suggests direct oral anticoagulant (DOACs) to be at least equally effective in general, the efficacy of individual DOACs remains unclear., Methods: A literature search was performed in EMBASE, MEDLINE and Web of Science looking for randomized controlled trials (RCTs) and non-randomized controlled studies of interventions (NRSI) comparing individual DOACs to VKAs for the treatment of LVT. Individual patient data was reconstructed and incorporated in a Bayesian network meta-analysis (NMA) and a Cox frailty regression model., Results: A total of 2545 patients across 19 studies (4 RCTs, 15 NRSI) were included. 1738 received VKAs, 581 received Rivaroxaban, 226 received Apixaban, 82 received Dabigatran and 2 received Edoxaban. LVT resolution was less likely with VKAs compared to Rivaroxaban in the time-to-event analysis (HR 0.66, 95% CI [0.49; 0.91], p = 0.01). There was no difference for other DOACs compared to VKAs. Rivaroxaban reduced ischemic stroke compared to VKAs (OR 0.18, 95% CrI [0.05; 0.49]), other DOACs did not., Conclusion: In this NMA, Rivaroxaban showed faster LVT resolution and consecutively lower odds of ischemic stroke than VKAs while Apixaban and Dabigatran showed at least equal efficacy. Given the quality and size of the available studies, these differences between individual DOACs should be acknowledged as hypothesis generating only. Future adequately powered randomized controlled trials are needed to assess possible time-varying effects between individual DOACs., (© 2024. Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Physical activity prevents cardiovascular disease, but it may also trigger acute cardiac events like sudden cardiac death in patients with underlying heart disease. The chance of surviving an out-of-hospital cardiac arrest remains low, despite improving medical treatment and rescue chain. Prior studies signaled increased survival in exercise related out-of-hospital cardiac arrest., Objective: The aim of this study was to evaluate the differences between exercise related out-of-hospital cardiac arrest and out-of-hospital cardiac arrest during daily activity in an urban setting., Methods: Retrospective analysis of all out-of-hospital cardiac arrests from 2014 to 2021 treated at a cardiac arrest center of a tertiary hospital. The primary outcome was survival to discharge. Secondary outcomes included differences in pre-hospital care, in-hospital treatment, hypoxic ischemic encephalopathy, and laboratory parameters., Results: 478 OHCA patients were reviewed of which 432 patients (exercise related 36 (8.4%) vs. daily activity 396 (91.6%)) were included in the analysis. Patients suffering an exercise related arrest were younger (57 vs 65 years, p  = 0.002) and mostly male (88.9 vs 74.5%, p  = 0.054).The exercise related cohort received bystander cardiopulmonary resuscitation (77.8 vs 53.4%, p  = 0.005) to a higher extent and had a shorter no-flow time (1.5 vs 2 min, p  = 0.049). Exercise related arrest patients more often presented with a shockable rhythm (80.6 vs 64.1%, p  = 0.032).At hospital admission exercise related arrest patients had a higher initial pH (7.24 vs 7.19, p  = 0.015). In the exercise related group, a cardiac cause was numerically more frequent compared to the daily activity group (80.6 vs 68.7%, p  = 0.09). In both groups myocardial infarction (47.2 vs 43.2%) was the most common cause, but a primary arrhythmic event (33.3 vs 25.5%) was more often documented in exercise related arrest patients. Exercise related arrest was mostly related to endurance training (52.8%) followed by ball sports (19.4%) and occurred directly during exercise in 77.8% of cases. Patients suffering exercise related arrest had higher survival till discharge (66.7 vs 47.7%, p  = 0.036)., Conclusion: Based on this observational data from a highly selected group of out-of-hospital cardiac arrest patients treated at a cardiac arrest center, patients suffering an exercise related out-of-hospital cardiac arrest, differed in substantial characteristics and in the first line response compared to daily activity out-of-hospital cardiac arrest patients. The better survival to discharge of the exercise related out-of-hospital cardiac arrest group might be driven by these beneficial differences. This study underlines the need for public awareness for the importance of a fast first response and a broad distribution of automated external defibrillators in public sport areas since most of the exercise related out-of-hospital cardiac arrest patients presented with a cardiac cause and an initial shockable rhythm., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors.)

Background: Percutaneous coronary intervention (PCI) is standard of care in patients with acute coronary syndrome (ACS) suitable for interventional revascularization. Intracoronary imaging by optical coherence tomography (OCT) expanded treatment approaches adding diagnostic information and contributing to stent optimization., Objectives: This meta-analysis aimed to assess the effects of OCT-guided vs. angiography-guided PCI in treatment of ACS., Methods: A structured literature search was performed. All controlled trials evaluating OCT-guided vs. angiography-guided PCI in patients with ACS were eligible. The primary end point was major adverse cardiac events (MACE)., Results: Eight studies enrolling 2612 patients with ACS were eligible. 1263 patients underwent OCT-guided and 1,349 patients angiography-guided PCI. OCT guidance was associated with a 30% lower likelihood of MACE (OR 0.70, 95% CI 0.53-0.93, p = 0.01, I 2  = 1%). OCT-guided PCI was also associated with significantly decreased cardiac mortality (OR 0.49, 95% CI 0.25-0.96, p = 0.04, I 2  = 0%). There was no detectable difference in all-cause mortality (OR 1.08, 95% CI 0.51-2.31, p = 0.83, I 2  = 0). Patients in OCT-guided group less frequently required target lesion revascularization (OR 0.26, 95% CI 0.07-0.95, p = 0.04, I 2  = 0%). Analysis of myocardial infarction did not result in significant treatment differences. In subgroup or sensitivity analysis the observed advantages of OCT-guided PCI were not replicable., Conclusion: The evidence suggests that PCI guidance with OCT in ACS decreases MACE, cardiac death and target lesion revascularization compared to angiography. On individual study level, in subgroup or sensitivity analyses these advantages were not thoroughly replicable., (© 2023. The Author(s).)

Background/Objectives: Chronic total occlusion (CTO) is a prevalent finding in patients with coronary artery disease and is associated with increased mortality. Prior reports on the efficacy of percutaneous coronary intervention (PCI) compared to optimal medical therapy (OMT) were controversial. Following the emergence of recently published new evidence, a meta-analysis is warranted. The current meta-analysis assessed the effects of PCI compared to OMT in the treatment of CTO. Methods: A structured literature search was performed. Randomized controlled trials (RCTs) and non-randomized controlled studies of interventions were eligible. The primary outcome was an accumulated composite of cardiac mortality, myocardial infarction and target vessel/lesion revascularization events. Results: Thirty-two studies reporting on 11260 patients were included. Of these, 5712 (50.7%) were assigned to the PCI and 5548 (49.3%) were allocated to the OMT group. The primary outcome occurred in 14.6% of the PCI and 20.1% of the OMT group (12 trials, OR 0.66, 95% CI 0.50 to 0.88, p = 0.005, I 2 = 67%). Subgrouping demonstrated a consistent reduction in the primary outcome for the PCI group in RCTs (six trials, OR 0.58, 95% CI 0.33 to 0.99, p = 0.05). The primary outcome reduction was irrespective of the study design, and it was replicable in sensitivity and subgroup analyses. Advantages in other outcomes were rather related to statistical pooling effects and dominated by observational data. Conclusions: CTO-PCI was associated with improved patient-oriented primary outcome compared to OMT in a study-level meta-analysis. This composite outcome effect was mainly driven by target vessel treatment, but a significant reduction in mortality and myocardial infarction was observed, irrespectively. These findings have hypothesis-generating implications. Future RCTs with adequate statistical power are eagerly awaited.

Background: In patients not suitable for transfemoral transcatheter aortic valve implantation (TAVI), several access strategies can be chosen., Aim: To evaluate the use and patient outcomes of transaxillary (TAx), transapical (TA), and transaortic (TAo) as alternative access for TAVI in Germany; to further evaluate surgical cutdown vs. percutaneous TAx access., Methods: All patients entered the German Aortic Valve Registry (GARY) between 2011 and 2019 who underwent non-transfemoral TAVI were included in this analysis. Patients with TA, TAo, or TAx TAVI were compared using a weighted propensity score model. Furthermore, a subgroup analysis was performed for TAx regarding the percutaneous or surgical cutdown approach., Results: Overall, 9686 patients received a non-transfemoral access. A total of 8918 patients (92.1%) underwent TA, 398 (4.1%) TAo, and 370 (3.8%) TAx approaches. Within the TAx subgroup, 141 patients (38.1%) received subclavian cutdown, while 200 (54.1%) underwent a percutaneous approach. The TA patients had a significantly lower 30-day survival than TAx patients (TA 90.92% vs. TAx 95.59%, p = 0.006; TAo 92.22% vs. TAx 95.59%, p = 0.102). Comparing percutaneous and cutdown TAx approaches, no significant differences were seen. However, more vascular complications occurred (TA 1.8%, TAo 2.4%, TAx 12.2%; p < .001), and the hospital length of stay was shorter (TA 12.9 days, TAo 14.1 days, TAx 12 days; p < .001) after TAx access., Conclusion: It may be reasonable to consider TAx access first in patients not suitable for TF-TAVI, because the 30-day survival was higher compared with TA access and the 1-year survival was higher compared with TAo access. It remains important for the heart teams to offer alternative access modalities for patients not amenable to the standard TF-TAVI approaches., (© 2024. The Author(s).)

Purpose: Neurological damage is the main cause of death or withdrawal of care in comatose survivors of cardiac arrest (CA). Hypoxemia and hyperoxemia following CA were described as potentially harmful, but reports were inconsistent. Current guidelines lack specific oxygen targets after return of spontaneous circulation (ROSC)., Objectives: The current meta-analysis assessed the effects of restrictive compared to high-dose oxygenation strategy in survivors of CA., Methods: A structured literature search was performed. Randomized controlled trials (RCTs) comparing two competing oxygenation strategies in post-ROSC management after CA were eligible. The primary end point was short-term survival (≤ 90 days). The meta-analysis was prospectively registered in PROSPERO database (CRD42023444513)., Results: Eight RCTs enrolling 1941 patients were eligible. Restrictive oxygenation was applied to 964 patients, high-dose regimens were used in 977 participants. Short-term survival rate was 55.7% in restrictive and 56% in high-dose oxygenation group (8 trials, RR 0.99, 95% CI 0.90 to 1.10, P = 0.90, I 2  = 18%, no difference). No evidence for a difference was detected in survival to hospital discharge (5 trials, RR 0.98, 95% CI 0.79 to 1.21, P = 0.84, I 2  = 32%). Episodes of hypoxemia more frequently occurred in restrictive oxygenation group (4 trials, RR 2.06, 95% CI 1.47 to 2.89, P = 0.004, I 2  = 13%)., Conclusion: Restrictive and high-dose oxygenation strategy following CA did not result in differences in short-term or in-hospital survival. Restrictive oxygenation strategy may increase episodes of hypoxemia, even with restrictive oxygenation targets exceeding intended saturation levels, but the clinical relevance is unknown. There is still a wide gap in the evidence of optimized oxygenation in post-ROSC management and specific targets cannot be concluded from the current evidence., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Objective: Percutaneous femoral artery access is being increasingly used in endovascular aortic repair (EVAR). The technique can be challenging in patients with previously surgically exposed or repaired femoral arteries because of excessive scar tissue. However, a successful percutaneous approach may cause less morbidity than a "re-do" open femoral approach. The aim of this study was to assess the impact of prior open surgical femoral exposure on technical success and clinical outcomes of percutaneous approach., Methods: This study retrospectively reviewed the clinical data of patients who underwent percutaneous EVAR between 2010 and 2020 at 2 major aortic centers. Patients were divided into 2 groups (with or without prior open surgical femoral access) for analysis of clinical outcomes. Only punctures with sheaths ≥12Fr were included for analysis. The access and (pre)closure techniques were similar in both institutions. Primary end points were intraoperative technical success, access-related revision, and access complications. A multivariate analysis was performed to identify determinants of conversion to open approach and femoral access complications in intact and re-do groins., Results: A total of 632 patients underwent percutaneous (complex) EVAR: 98 had prior open surgical femoral access and 534 patients underwent de novo femoral percutaneous access. A total of 1099 femoral artery punctures were performed: 149 in re-do and 950 in intact groins. The extent of endovascular repair included 159 infrarenal, 82 thoracic, 368 fenestrated/branched, and 23 iliac branch devices. No significant differences were seen in technical success (re-do 93.3% vs intact 95.3%, p=0.311), access-related surgical revision (0.7% vs 0.6%, p=0.950), and access complications (2.7% vs 4.0%, p=0.443). For the whole group, significant predictors for access complications in multivariate analyses were main access site (odds ratio [OR] 2.39; 95% confidence interval [CI] 1.07%-5.35%; p=0.033) and increase of the procedure time per hour (OR 1.65; 95% CI 1.34%-2.04%; p<0.001), while increase in sheath-vessel ratio had a protective effect (OR 0.33; 95% CI 0.127%-0.85%; p=0.021). Surgical conversion was predicted by main access site (OR 2.32; 95% CI 1.28%-4.19%; p=0.007) and calcification of 50% to 75% of the circumference of the access vessel (OR 3.29; 95% CI 1.38%-7.86%; p=0.005)., Conclusion: Within our population prior open surgical femoral artery exposure or repair had no negative impact on the technical success and clinical outcomes of percutaneous (complex) endovascular aortic aneurysm repair.

Background: Out-of-hospital cardiac arrest (OHCA) has a high prevalence of obstructive coronary artery disease and total coronary occlusion. Consequently, these patients are frequently loaded with antiplatelets and anticoagulants before hospital arrival. However, OHCA patients have multiple non-cardiac causes and high susceptibility for bleeding. In brief, there is a gap in the evidence for loading in OHCA patients. Objective: The current analysis stratified the outcome of patients with OHCA according to pre-clinical loading. Material and Methods: In a retrospective analysis of an all-comer OHCA registry, patients were stratified by loading with aspirin (ASA) and unfractionated heparin (UFH). Bleeding rate, survival to hospital discharge and favorable neurological outcomes were measured. Results: Overall, 272 patients were included, of whom 142 were loaded. Acute coronary syndrome was diagnosed in 103 patients. One-third of STEMIs were not loaded. Conversely, 54% with OHCA from non-ischemic causes were pretreated. Loading was associated with increased survival to hospital discharge (56.3 vs. 40.3%, p = 0.008) and a more favorable neurological outcome (80.7 vs. 62.6% p = 0.003). Prevalence of bleeding was comparable (26.8 vs. 31.5%, p = 0.740). Conclusions: Pre-clinical loading did not increase bleeding rates and was associated with favorable survival. Overtreatment of OHCA with non-ischemic origin, but also undertreatment of STEMI-OHCA were documented. Loading without definite diagnosis of sustained ischemia is debatable in the absence of reliable randomized controlled data.

Aims: This network meta-analysis aimed to assess the effect of early coronary angiography (CAG) compared with selective CAG (late and no CAG) for patients after out-of-hospital cardiac arrest without ST-elevation myocardial infarction (NSTE-OHCA)., Methods and Results: A systematic literature search was performed using the EMBASE, MEDLINE and Web of Science databases without restrictions on publication date. The last search was performed on 15 July 2022. Randomized controlled trials (RCTs) and non-randomized studies (NRS) comparing the effect of early CAG to selective CAG after NSTE-OHCA on survival and/or neurological outcomes were included. Meta-analyses were performed based on a DerSimonian-Laird random effects model. A total of 18 studies were identified by the literature search. After the exclusion of two studies due to high risk of bias, 16 studies (six RCTs, ten NRS) were included in the final analyses. Meta-analyses showed a statistically significant increase in survival after early CAG compared with selective CAG in the overall analysis [OR: 1.40, 95% confidence interval (CI): (1.12-1.76), P < 0.01, I2 = 68%]. This effect was lost in the subgroup analysis of RCTs [OR: 0.89, 95% CI: (0.73-1.10), P = 0.29, I2 = 0%]. Random effects model network meta-analysis of NRS based on a Bayesian method showed statistically significant increased survival after late compared with early CAG [OR: 4.20, 95% CI: (1.22, 20.91)]., Conclusion: The previously reported superiority of early CAG after NSTE-OHCA is based on NRS at high risk of selection and survivorship bias. The meta-analysis of RCTs does not support routinely performing early CAG after NSTE-OHCA., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: The optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined., Objectives: This study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD., Methods: Patients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site-related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score)., Results: Among the 1,707 patients included in the registry, 518 (30.3%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6%) with TTA, and 547 (32.0%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site-related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (P interaction  = 0.049)., Conclusions: Among patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA., Competing Interests: Funding Support and Author Disclosures Dr Palmerini has received speaker fees from Edwards Lifesciences and Medtronic. Dr Saia has received consulting and lecture fees from Abbott, Edwards Lifesciences, and Medtronic. Dr Kim has received personal fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Merill Life Sciences, and Shockwave Medical. Dr Søndergaard has received consulting fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and Sahajanand Medical Technologies. Dr Burzotta has received speaker fees from Abiomed, Abbott, Medtronic, and Terumo. Dr Romagnoli has received speaker fees by Abbott Vascular, Abiomed, and Medtronic. Dr Van Mieghem has received research grant support from Abbott Vascular, Biotronik, Boston Scientific, Medtronic, Edwards Lifesciences, Abiomed, PulseCath BV, and Daiichi Sankyo. Dr Pilgrim has received research grants to his institution from Boston Scientific, Biotronik, and Edwards Lifesciences; and honoraria from Biotronik, Boston Scientific, Medtronic, Abbott, and HighLife SAS. Dr Adam has received personal and proctoring fees from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic (during the conduct of the study). Dr Di Mario has received research grants to his institution from Abbott, Amgen, Boston Scientific, Chiesi, Daiichi Sankyo, Edwards Lifesciences, and Volcano Philips. Dr Toggweiler has served as a proctor/consultant for Medtronic, Edwards Lifesciences, Biosensors, Boston Scientific, and Abbott Vascular; has served consultant for Medira, AtHeart Medical, Veosource, Shockwave, Teleflex, and Polares Medical; has received institutional research grants from Biosensors, Boston Scientific, and Fumedica; and holds equity in Hi-D Imaging. Dr Testa has received consulting fees from and served as a proctor Abbott, Boston Scientific, Medtronic, and Merrill. Dr Berti has served as a proctor for Edwards Lifesciences, Abbott, and Boston Scientific. Dr Ancona has received consultant fees from Abbott. Dr Montorfano has received proctor fees from Abbott, Edwards Lifesciences, and Boston Scientific. Dr Castriota has received proctoring fees from Abbott and Medtronic. Dr Petronio has received consultant and research funds from Medtronic, Boston Scientific, and Abbott. Dr Barbanti has served as a consultant for Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Tamburino has received speaker honoraria from Abbott and Medtronic. Dr Nickenig has received lecture or advisory board honoraria from Abbott, Amarin, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronik, Bristol Myers Squibb, Boehringer Ingelheim, CardioValve, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, and Sanofi; owns stock options with Beren, Cardiovalve; has served in clinical trials with Abbott, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronik, Bristol Myers Squibb, Boehringer Ingelheim, CardioValve, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, and Sanofi; and has received research funding from the Deutsche Forschungsgemeinschaft, the Bundeministerium für Bildung und Forschun, the European Union, Abbott, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Edwards Lifesciences, Medtronic, Novartis, and Pfizer. Dr Stefanini has received speaker fees from Abbott Vascular, Boston Scientific, and Pfizer/Bristol Myers Squibb; research grants to his institution from Boston Scientific. Dr Latib has served as a consultant for Abbott, Medtronic, Edwards Lifesciences, Boston Scientific, Neovasc, Shifamed, and Philips. Dr Porto has received consulting or speaker fees from Biotronik, Abiomed, Medtronic, Terumo, Philips, Sanofi, Amgen, Daiichi Sankyo, AstraZeneca, and Bayer, not related to this work. Dr Grube has served on the Speakers Bureau/Scientific Advisory Board for Medtronic, Boston Scientific, JenaValve, and High Life; and owns equity interest in Millipede, Pi-Cardia, Ancora, Laminar, ReNiva Medical, and Shockwave. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, and Infraredx; has served as a consultant for Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Cardiomech, Gore, Amgen, and Adona Medical; owns equity/options in Ancora, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter; has a daughter who is an employee at Medtronic; and his employer (Mount Sinai Hospital) has received research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems, Philips, Biosense Webster, Shockwave, Vascular Dynamics, and V-wave. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Incidence and mortality of cardiogenic shock (CS) in patients with acute myocardial infarction (AMI) remain high despite substantial therapy improvements in acute percutaneous coronary intervention over the last decades. Unloading the left ventricle in patients with Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can be performed by using an intra-aortic balloon pumps' (IABP) afterload reduction, which might be especially beneficial in AMI patients with CS., Objective: The objective of this meta-analysis was to assess the effect of VA-ECMO + IABP vs. VA-ECMO treatment on the mortality of patients with CS due to AMI., Methods: A systematic literature search was performed using EMBASE, COCHRANE, and MEDLINE databases. Studies comparing the effect of VA-ECMO + IABP vs. VA-ECMO on mortality of patients with AMI were included. Meta-analyses were performed to analyze the effect of the chosen treatment on 30-day/in-hospital mortality., Results: Twelve studies were identified by the literature search, including a total of 5,063 patients, 81.5% were male and the mean age was 65.9 years. One thousand one hundred and thirty-six patients received treatment with VA-ECMO in combination with IABP and 2,964 patients received VA-ECMO treatment only. The performed meta-analysis showed decreased mortality at 30-days/in-hospital after VA-ECMO + IABP compared to VA-ECMO only for patients with cardiogenic shock after AMI (OR 0.36, 95% CI 0.30-0.44, P ≤0.001). Combination of VA-ECMO + IABP was associated with higher rates of weaning success (OR 0.29, 95% CI 0.16-0.53, P < 0.001) without an increase of vascular access complications (OR 0.85, 95% CI 0.35-2.08, P = 0.72)., Conclusion: In this meta-analysis, combination therapy of VA-ECMO + IABP was superior to VA-ECMO only therapy in patients with CS due to AMI. In the absence of randomized data, these results are hypothesis generating only., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Meertens, Tichelbäcker, Macherey-Meyer, Heyne, Braumann, Nießen, Baldus, Adler and Lee.)

Purpose: Upper extremity access (UEA) for antegrade cannulation of aortic side branches is a relevant part of endovascular treatment of complex aortic aneurysms and can be achieved using several techniques, sites, and sides. The purpose of this study was to evaluate different UEA strategies in a multicenter registry of complex endovascular aortic aneurysm repair (EVAR)., Methods: In six aortic centers in the Netherlands, all endovascular aortic procedures from 2006 to 2019 were retrospectively reviewed. Patients who received UEA during complex EVAR were included. The primary outcome was a composite end point of any access complication, excluding minor hematomas. Secondary outcomes were access characteristics, access complications considered individually, access reinterventions, and incidence of ischemic cerebrovascular events., Results: A total of 417 patients underwent 437 UEA for 303 fenestrated/branched EVARs and 114 chimney EVARs. Twenty patients had bilateral, 295 left-sided, and 102 right-sided UEA. A total of 413 approaches were performed surgically and 24 percutaneously. Distal brachial access (DBA) was used in 89 cases, medial brachial access (MBA) in 149, proximal brachial access (PBA) in 140, and axillary access (AA) in 59 cases. No significant differences regarding the composite end point of access complications were seen (DBA: 11.3% vs MBA: 6.7% vs PBA: 13.6% vs AA: 10.2%; P = .29). Postoperative neuropathy occurred most after PBA (DBA: 1.1% vs MBA: 1.3% vs PBA: 9.3% vs AA: 5.1%; P = .003). There were no differences in cerebrovascular complications between access sides (right: 5.9% vs left: 4.1% vs bilateral: 5%; P = .75). Significantly more overall access complications were seen after a percutaneous approach (29.2% vs 6.8%; P = .002). In multivariate analysis, the risk for access complications after an open approach was decreased by male sex (odds ratio [OR]: 0.27; 95% confidence interval [CI]: 0.10-0.72; P = .009), whereas an increase in age per year (OR: 1.08; 95% CI: 1.004-1.179; P = .039) and diabetes mellitus type 2 (OR: 3.70; 95% CI: 1.20-11.41; P = .023) increased the risk., Conclusions: Between the four access localizations, there were no differences in overall access complications. Female sex, diabetes mellitus type 2, and aging increased the risk for access complications after a surgical approach. Furthermore, a percutaneous UEA resulted in higher complication rates than a surgical approach., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: Periinterventional stroke is one of the most feared potential complication, among patients treated with transcatheter aortic valve implantation (TAVI). The purpose of this review was to investigate the incidence of cerebrovascular events and the influence of postinterventional neurologic check-up in patients undergoing TAVI., Methods: A systematic review and meta-analysis were conducted according to the PRISMA guideline. Three separate electronic searches of the public domains Medline and Clinicaltrials.gov were performed to identify the 30-day incidence of stroke within randomized controlled trials (RCTs) and registries for patients undergoing a TAVI procedure. A meta-analysis was conducted to evaluate the 30-day incidence of stroke within RCTs. Furthermore, we pooled the RCTs in which a scheduled neurological check-up was conducted or not to investigate the effect of this intervention., Results: Twenty-three studies including 399,491 TAVI patients were included, 6370 from RCTs, 833 from cerebral-embolic protection device RCTs and 392,288 were adopted from registries. The mean 30-day incidence of stroke among all reviewed studies was 2.33%. In RCTs evaluating TAVI the pooled stroke incidence was 3.86%, among RCTs focused CEP the incidence was 6.36% and in registries the incidence was 2.29%. Ten RCTs conducted scheduled neurological check-ups, the incidence in these was 4.03% and among the remaining RCTs it was 2.47%. In the meta-analysis, the pooled 30-day stroke incidence was 3.61% (95% CI 2.57-4.79%)., Conclusion: This systematic review demonstrates that the stroke incidences following TAVI differ strongly according to the study design and neurological follow-up. Intense neurological testing increases the incidence of a stroke after TAVI., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

The effect of respiratory infectious diseases on STEMI incidence, but also STEMI care is not well understood. The Influenza 2017/2018 epidemic and the COVID-19 pandemic were chosen as observational periods to investigate the effect of respiratory virus diseases on these outcomes in a metropolitan area with an established STEMI network. We analyzed data on incidence and care during the COVID-19 pandemic, Influenza 2017/2018 epidemic and corresponding seasonal control periods. Three comparisons were performed: (1) COVID-19 pandemic group versus pandemic control group, (2) COVID-19 pandemic group versus Influenza 2017/2018 epidemic group and (3) Influenza 2017/2018 epidemic group versus epidemic control group. We used Student's t-test, Fisher's exact test and Chi square test for statistical analysis. 1455 patients were eligible. The daily STEMI incidence was 1.49 during the COVID-19 pandemic, 1.40 for the pandemic season control period, 1.22 during the Influenza 2017/2018 epidemic and 1.28 during the epidemic season control group. Median symptom-to-contact time was 180 min during the COVID-19 pandemic. In the pandemic season control group it was 90 min (p = 0.183), and in the Influenza 2017/2018 cohort it was 90 min, too (p = 0.216). Interval in the epidemic control group was 79 min (p = 0.733). The COVID-19 group had a door-to-balloon time of 49 min, corresponding intervals were 39 min for the pandemic season group (p = 0.038), 37 min for the Influenza 2017/2018 group (p = 0.421), and 38 min for the epidemic season control group (p = 0.429). In-hospital mortality was 6.1% for the COVID-19 group, 5.9% for the Influenza 2017/2018 group (p = 1.0), 11% and 11.2% for the season control groups. The respiratory virus diseases neither resulted in an overall treatment delay, nor did they cause an increase in STEMI mortality or incidence. The registry analysis demonstrated a prolonged door-to-balloon time during the COVID-19 pandemic., (© 2021. The Author(s).)

Purpose: The purpose of this study was to review the risk of developing cerebrovascular complications from upper extremity access during endovascular treatment of complex aortic aneurysms., Methods: A systematic review and meta-analysis were conducted according to the PRISMA guideline. An electronic search of the public domains Medline (PubMed), Embase (Ovid), Web of Science and Cochrane Library was performed to identify studies related to the treatment of aortic aneurysms involving upper extremity access. Meta-analysis was used to compare the rate of cerebrovascular event after left, right and bilateral upper extremity access. Results are presented as relative risk (RR) and 95% confidence intervals (CIs)., Results: Thirteen studies including 1276 patients with complex endovascular treatment of aortic aneurysms using upper extremity access were included in the systematic review. Left upper extremity access (UEA) was used in 1028 procedures, right access in 148 and bilateral access in 100 procedures. The rate of cerebrovascular complications for patients treated through left UEA was 1.7%, through right UEA 4% and through bilateral UEA 5%. In the meta-analysis, we included seven studies involving 645 patients treated with a left upper extremity access, 87 patients through a right and 100 patients through a bilateral upper extremity access. Patients, who underwent right-sided (RR 5.01, 95% CI 1.51-16.58, P = 0.008) or bilateral UEA (RR 4.57, 95% CI 1.23-17.04, P = 0.02), had a significantly increased risk of cerebrovascular events compared to those who had a left-sided approach., Conclusion: Left upper extremity access is associated with a significantly lower rate of cerebrovascular complications as compared to right or bilateral upper extremity access.

Purpose: To evaluate the feasibility and safety of the suture-mediated ProGlide device in closure of the brachial artery after endovascular interventions. Materials and Methods: From 2016 to 2017, a pilot study was performed using the ProGlide to achieve hemostasis after percutaneous access of distal brachial arteries >4 mm in diameter. In an interim analysis, the results were compared to a matched control group taken from a 60-patient historical cohort who underwent brachial artery access and manual compression to achieve hemostasis between 2014 and 2017. The primary outcome was access-related reintervention and the secondary outcome was the incidence of access-site complications. Results: Seven patients (mean age 67.9 years; 6 men) were enrolled in the study before it was stopped in 2017. Four patients experienced 6 access-site complications (neuropathy, hematoma, occlusion, and pseudoaneurysm). These resulted in 3 access-related reinterventions: surgical evacuation of a hematoma, thrombectomy of the occluded brachial artery, and surgical repair of the pseudoaneurysm. In the interim comparison to the 19 matched patients (mean age 61.9 years; 6 men), the ProGlide group had proportionally more patients experiencing access-related complications (57% vs 16% for manual compression, p=0.035) and resultant reinterventions (43% vs 11%, p=0.064). Based on this data the trial was stopped. Conclusion: Considering this experience, it is not advisable to use the ProGlide in transbrachial endovascular interventions due to the high incidence of complications and access-related reinterventions.

Purpose: To present a systematic review and meta-analysis comparing the transradial approach for aortoiliac and femoropopliteal interventions to the traditional transfemoral access., Methods: A search of the public domain databases MEDLINE, SCOPUS, Web of Science, and Cochrane Library Databases was performed to identify studies related to the use of the transradial approach for infra-aortic procedures. Meta-analysis was used to compare the transradial to the transfemoral route in terms of procedure success, complications, procedure parameters, and hospital length of stay. Results are presented as the odds ratio (OR) and 95% confidence interval (CI)., Results: Nineteen studies containing 638 patients with transradial access for lower limb interventions were selected. Lesions were treated from the aortic bifurcation down to the popliteal artery. The mean technical success rate was 90.9%, conversion to a transfemoral approach was necessary in 9.9%, and complications were reported in 1.9%. The meta-analysis included 4 comparative studies involving 114 transradial and 208 transfemoral procedures. There was no significant advantage of either approach in terms of procedure success (OR 5.0, 95% CI 0.49 to 50.83, p=0.17), but the risk of developing a complication was significantly lower (OR 0.25, 95% CI 0.07 to 0.86, p=0.03) with the transradial approach., Conclusion: Transradial access for lower limb endovascular interventions can be performed with comparable technical success and a lower overall complication profile compared to transfemoral access.