Periprocedural Complications Research Articles

TRanscatheter Aortic-Valve Implantation with or without on-site Cardiac Surgery: the TRACS trial: TAVI in centers without on-site cardiac surgery

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

Association of cardiac amyloidosis with periprocedural complications in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement: a systematic review and meta-analysis

Abstract Introduction Cardiac amyloidosis (CA) has been frequently observed in patients with aortic stenosis (AS). While transcatheter aortic valve replacement (TAVR) may be an option, the association of CA with risk of periprocedural complications has not been well evaluated. Purpose This study aimed to evaluate the association of CA with periprocedural complications after TAVR in patients with severe AS. Methods A literature search was performed for studies evaluating patients with severe AS undergoing AVR, comparing periprocedural safety endpoints for patients with and without CA. The primary endpoints were vascular complications and bradyarrhythmias post-TAVR requiring permanent pacemaker (PPM) implantation. Secondary endpoints included periprocedural acute kidney injury (AKI), cerebrovascular accidents (CVA), and major bleeding events. Endpoints were defined using the Valve Academic Research Consortium-2 criteria. The search was not restricted to time or publication status. Results 6 studies with 1,138 patients with severe AS (150 with CA, 988 without CA) met inclusion criteria. Mean age was 82 years, 52.4% were men, all except 1 study assessed only patients with ATTR CA. Echocardiographic mean aortic valve parameters included valve area of 0.718 cm2, mean gradient of 40.8, and peak velocity of 4.13 m/s. The mean left ventricular ejection fraction was 55.2%. The presence of CA was not associated with an increased risk of periprocedural vascular complications (OR 0.69, 95% CI 0.25-1.88; p=0.47). While a trend toward higher risk of periprocedural PPM implantation was observed in patients with CA, this finding did not reach statistical significance (OR 1.51; 95% CI 0.77-2.94; p=0.23). The presence of CA was not associated with increased risk of periprocedural AKI, CVA, or major bleeding (OR 1.3, 95% CI 0.32-5.3; p=0.72, OR 0.65, 95% CI 0.17-2.41; p=0.52; OR 0.55, 95% CI 0.16-1.87; p=0.34). Conclusion In the context of patients with severe AS undergoing TAVR, the presence of cardiac amyloidosis did not increase the risk of periprocedural complications, including vascular complications, AKI, CVA, or major bleeding. Although a trend toward a higher risk of bradyarrhythmias requiring PPM implantation was noted in patients with CA, further studies are warranted to confirm this observation. Overall, these findings contribute valuable insight into the safety profile of TAVR in the patients with CA.Figure 1Figure 2

Periprocedural complications during transvenous lead extraction. Lessons learned from the GermAn Laser Lead Extraction RegistrY (GALLERY)

Abstract Background Transvenous lead extraction (TLE) has become an established therapy for patients with cardiac device-related complications such as infection or lead dysfunction. Although safe and effective, periprocedural complications such as vascular or cardiac lacerations with the need for major surgical intervention occur and lead to morbidity and mortality. Objective & Methods The aim of this study was to conduct a retrospective analysis of the incidence, management and outcome of all major complications suffered by patients undergoing TLE in the GALLERY and to compare patient characteristics, procedural data and outcome against patients who suffered minor or no periprocedural complications. We performed multivariate regression analysis to identify independent predictors for death in patients with major complications. Results We identified 52 patients with major (Group A), 57 patients with minor (Groups B) and 2415 patients with no periprocedural complications (Group C) undergoing TLE in the GALLERY (2.1%, 2.3% and 95.7% of total patients, respectively). There were no differences in age (67.4±14.0 vs. 66.6±13.5 vs. 68.1±13.8 years; p=0.612), body mass index (BMI – 26.5±5.4 vs. 26.1±4.2 vs. 27.1±4.7 kg/m2; p=0.140) or other comorbidities, such as arterial hypertension or chronic kidney disease (CKD), except for more patients with diabetes mellitus (15.4 vs. 42.1 vs. 31.3%; p=0.01) in Group B and a trend towards less patients with previous cardiac surgery (15.4 vs. 35.1 vs. 24.2%; p=0.053) in Group A. Mean number of leads per patient were 2.5±1.1, 2.4±1.0 and 2.4±1.0 (p=0.645). Most common minor complication was pocket hematoma in 82.6% of cases. Laceration of the superior vena cava (SVC – 40.4%) was the most common major complication, followed by perforation of the right atrium (RA – 23.1%). Emergent median sternotomy was necessary in 80.8% of cases in Group A, of which 67.4% required cardiopulmonary bypass. Clinical success for TLE could only be achieved in 63.5% of cases in Group A, whereas Groups B and C achieved 100.0 and 98.5% (p<0.001), respectively. The mortality rate in Group A was 28.9%, in contrast to 5.3% and 3.0% in Groups B and C (p<0.001), which translates into a procedure-related mortality of 0.6% for the entire GALLERY. Septic shock was the most common cause of death in all groups (7.7 vs. 3.5 vs. 1.9%, p=0.013). Multivariate regression analysis revealed CKD (OR:4.7, 95%CI: 1.06-20.7, p=0.04) and previous cardiac surgery (OR:6.3, 95%CI: 1.2-33.6, p=0.03) as independent predictors for death in patients who suffered a major complication during TLE. Conclusion Although rare, TLE remains a procedure with potential for major complications such as lacerations of the SVC or perforation of the RA. Immediate availability of emergent surgical intervention ensures a survival rate of 71,1%. Previous cardiac surgery and CKD seem to be independent predictors for death in such patients.

Peri-procedural complications in patients with chronic thromboembolic pulmonary hypertension who underwent balloon pulmonary angioplasty

Abstract Background Complication rate in patients with chronic thrombo-embolic pulmonary hypertension (CTEPH) who undergo balloon pulmonary angioplasty (BPA) is high, especially in patients with compromised pulmonary hemodynamics. Purpose Here we describe complications based on the new definition in a cohort of CTEPH patients who underwent BPA. Methods All patients with CTEPH who completed BPA treatments before September 15th 2023 were selected from the CTEPH database. Peri-procedural complications were collected and classified according to the 2023 consensus paper on BPA in CTEPH patients. Complications were analyzed in subgroups of patients with pulmonary vascular resistance (PVR) or >6.6 WU and mean pulmonary artery pressure (mPAP) or >45 mmHg at first BPA. Results In total, 87 patients (63.2% women; mean age 61.1±14.0 years; 62.1% on dual PH targeted medical therapy) underwent 426 (mean 4.9±1.6 per patient) BPAs. Non-severe complications occurred in 59 (13.8%) of the interventions; in 47.1% of the patients; 64.4% were thoracic, and 35.6% were non-thoracic complications. The thoracic complications were mostly mild (71.1%) or moderate (28.9%), and none were severe. Patients with a PVR >6.6 WU (n=8) underwent more BPA-procedures (6.6±1.5 versus 4.6±1.5, p=0.002), had more overall complications (87.5% versus 40.6% of patients, p=0.020), and more thoracic complications (17.0% vs 6.8% of BPAs, p=0.013) than patients with PVR 6.6 WU. Patients with mPAP >45 mmHg (n=13) also had more BPA-procedures (6.5±1.7 versus 4.6±1.4, p<0.001), more overall complications (76.9% versus 43.5% of patients, p=0.027) and more thoracic complications (14.1% versus 7.9% of BPAs, p=0.039) than patients with mPAP 45 mmHg. Conclusions Complications occurred in 13.8% of BPA procedures and were mostly mild. Patients with increased pulmonary hemodynamics at baseline suffered more (thoracic) complications.Overview complications

Mortality rates in patients undergoing urgent versus elective transcatheter aortic valve replacement: a systematic review and meta-analysis

Abstract Background Patients with severe aortic stenosis (AoS) often present with acute heart failure and compensation, leading frequently to cardiogenic shock. Transcatheter Aortic Valve Replacement (TAVR) has been recently performed as a bailout treatment in such patients. The aim of our meta-analysis is to compare urgent TAVR to elective procedures. Methods We systematically screened three databases searching for studies comparing urgent versus elective TAVR. Primary endpoint is the 30-days mortality. Secondary endpoints included in-hospital mortality, device success, periprocedural vascular complications, 30-day stroke, 30-day acute kidney injury (AKI), permanent pacemaker implantation (PPM), moderate or severe paravalvular leakage and 30-day bleedings. Results Seventeen studies were included, with a total of 84,495 patients. Urgent TAVR was associated with an increased risk for 30-days mortality (RR: 2.53, 95% CI: 1.81 – 3.54), in-hospital mortality (RR: 2.67, 95% CI: 1.94 – 3.68), periprocedural vascular complications (RR: 1.91, 95% CI: 1.28 – 2.85) and AKI (RR: 2.83, 95% CI: 1.93 – 4.14), compared to elective procedure. No differences were observed in the rest secondary endpoints. Conclusions Urgent TAVR was associated with higher in-hospital and 30-day mortality, possibly driven by the increased incidence of AKI and vascular complications in urgent TAVR. The results highlight the importance of early TAVR in stable AoS patients.

Comparative effectiveness of pulsed field ablation and cryoballoon ablation for atrial fibrillation: a systematic review and meta-analysis

Abstract Background Cryoballoon ablation (CBA) is a well-established technique for treating atrial fibrillation (AF), with a low complication rate related to cryoenergy-induced lesions. Pulsed Field Ablation (PFA) has emerged as a non-thermal alternative, with promising potential to further reduce complications. Purpose We aim to conduct a systematic review and meta-analysis comparing the efficacy and safety of PFA versus CBA in patients with AF. Methods We conducted a systematic search across PubMed, Embase, and the Cochrane Central Register of Controlled Trials to identify randomized controlled trials (RCTs) or observational studies published between 2013 and 2024 that compared PFA and CBA ablation techniques in patients with AF. Statistical analysis was carried out utilizing RevMan 5.1.7. Heterogeneity was assessed with I² statistics; p-values inferior to 0.05 and I²>25% were considered as significant heterogeneity. Results A total of 840 studies were screened in the initial search, and 26 studies were selected for full-text review based on inclusion criteria. Out of these, 8 observational studies involving 3,113 patients were included. Among these, 1,088 (34.9%) underwent PFA, while 2,025 (65.0%) underwent CBA. Periprocedural complications were significantly lower in patients who underwent PFA compared with the CBA group (RR 0.46; 95% CI 0.29 to 0.74; p=0.001; I²=1%; Fig. 1A). Furthermore, there was a significant reduction in procedure time in the PFA group (MD -8.21 min; 95% CI -13.74 to -2.69; p=0.004; I²=96%; Fig. 1B). However, no statistically significant difference was observed among groups regarding fluoroscopy time (MD 1.63 min; 95% CI -0.22 to 3.48; p=0.08; I²=92%; Fig. 2A), or recurrence of atrial arrhythmias after the blanking period (RR 0.84; 95% CI 0.68 to 1.04; p=0.12; I²=6%; Fig. 2B). Additionally, a subgroup analysis involving only propensity score-matched cohorts was conducted but didn’t show any statistical difference for any outcomes evaluated. Conclusion In this systematic review and meta-analysis, PFA was associated with a lower risk of periprocedural complications and a shorter procedure duration, compared to CBA in patients with AF. Additionally, it didn’t show a potential for reducing the recurrence of atrial arrhythmias, and the data regarding fluoroscopy time were inconclusive.Primary outcomesSecondary outcomes

Intravascular lithotripsy in the management of underexpanded stents

Abstract Introduction Stent underexpansion significantly heightens the risk of major adverse cardiac events (MACE), and available treatment options for this condition remain limited. Intravascular Lithotripsy (IVL) technology disrupts superficial and deep calcium by using localized pulsative sonic pressure waves, emerges as a promising tool for underexpanded stents. Methods Following PRISMA guidelines, we systematically explored PubMed, SCOPUS, and Cochrane databases up to September 3, 2023, for studies evaluating IVL's safety and efficacy in treating underexpanded stents. We gathered angiographic (QCA) and intracoronary imaging (OCT or IVUS) data, examining the stent's minimal diameter stenosis (MDS), minimal lumen diameter (MLD), minimal stent area (MSA), and minimal lumen area (MLA) pre- and post-IVL application. Procedural success constituted the efficacy endpoint, while peri-procedural complications, in-hospital-30-days and long-term mortality, and MACE were safety endpoints Results This meta-analysis comprised 21 studies including 669 patients and 673 treated lesions in underexpanded stent. The mean age was 73.2 ± 2.1 years, with an overall IVL procedural success rate of 93% [(95% Confidence Interval (CI): 88%-96%, I2=29%), while the in-hospital-30-days and long-term mortality incidence were 1% (95% CI: 1%-3%, I2=0%) and 3% (95% CI: 2%-6%, I2=0), respectively. The 30-days target lesion revascularization (TLR) was approximately 6% (95% CI: 3%-12%, I2=50%). There was a significant increase in the MDS [Standardized Mean Difference (SMD): +50.52%, 95% CI: 39.4-61.6, I2=94%)] and in MSA (SMD: +3.52, 95% CI: 2.47 to -4.58, I2=83%) immediately after IVL application. It was observed a significant increase in MLD (SMD: +1.54, 95% CI: 1.09 to 1.98, I2=95%) and in the MLA (SMD: +3.64, 95% CI: 2.62-4.66, I2=5%). Major procedural and device related complications were 3% (95% CI: 1%-6%, I2=0%) and 1% (95% CI: 0%-2%, I2=85%) respectively. Notably low rates were observed for stent thrombosis (0%, 95% CI: 0%-2%, I2=0%), dissections (1%, 95% CI: 1%-4%, I2=0%), perforations (1%, 95% CI: 1%-3%, I2=0%) and no-reflow (0%, 95% CI: 0%-1%, I2=0%). Conclusions IVL demonstrates promise as a safe and effective strategy for underexpanded stent treatment, characterized by low rates of periprocedural complications. Future prospective studies are now warranted to compare IVL to other lesion preparation strategies.30day All-Cause Mortality after IVL use.Minimum Stent Diameter after IVL use.

Predictors of periprocedural myocardial infarction following percutaneous coronary intervenction in NSTEMI

Abstract Background Percutaneous coronary intervention (PCI) has demonstrated a significant positive prognostic impact on outcomes in patients with Non-ST-elevation myocardial infarction (NSTEMI). However, PCI is associated with an increased risk of periprocedural complications, among which periprocedural myocardial infarction (PMI). Although risk factors of periprocedural events are only well established in patients undergoing PCI for chronic coronary syndrome with normal baseline cardiac troponin (cTn) levels, evidence on predictors of additional post-PCI myocardial infarction in patients with acute coronary syndrome who present elevated cTn levels at baseline (pre-PCI) is missing. Purpose To identify the predictors of PMI in patients affected by NSTEMI undergoing PCI. Methods We prospectively evaluated all NSTEMI patients admitted to our coronary care unit from 2017 to 2022 who underwent PCI. NSTEMI patients were managed according to the current European guidelines criteria. The diagnosis of PMI (type 4a myocardial infarction) was based on the Fourth Universal Definition of Myocardial Infarction. We only enrolled patients with stable (≤ 20% variation) or falling pre-procedure baseline cTn values. A multivariable logistic regression analysis was performed to investigate the factors independently associated with the occurrence of PMI after PCI. For the analysis, we selected the main known predictors of PMI after elective PCI, specifically age, serum creatinine, GRACE score > 140, multivessel disease, coronary bifurcation PCI, left main or proximal left anterior descending PCI, multivessel PCI and stent length ≥ 60 mm. Results The final court of the study included 1412 patients. PMI was recognized in 240 patients (17.0%). Although the patients who developed PMI had a higher risk profile as documented by a higher mean age, a higher complexity of atherosclerotic disease, and thus a significant technical difficulty of PCI compared to other patients, according to the multivariable model, only age [OR: 1.02 (95% CI: 1.01-1.04); p=0.006], coronary bifurcation PCI [OR: 3.71 (95% CI: 2.70-5.10); p<0.001], and stent length ≥ 60 mm [OR: 1.87 (95% CI: 1.30-2.68); p=0.001] were independent predictors of PMI. Interestingly, despite previous studies have demonstrated a predictive role of procedural complexity features, this was not completely confirmed by our analysis, in which left main or proximal left anterior descending PCI [OR: 0.92 (95% CI: 0.66-1.26); p=0.596] and multivessel PCI [OR: 0.83 (95% CI: 0.56-1.23); p=0.357] were not associated with an increased risk of periprocedural ischemic complications. Conclusions Among NSTEMI patients undergoing PCI, age, coronary bifurcation PCI and stent length ≥ 60 mm represent independent predictive factors of type 4a MI. This finding may have important clinical implications for clinical practice, providing valuable insights for the identification of higher-risk patients that can benefit from a more aggressive treatment.

Comparison of pulsed field ablation versus cryoballon and radiofrequency ablation for pulmonary vein isolation in atrial fibrillation patients with heart failure

Abstract Background Pulmonary vein isolation (PVI) is the gold standard for atrial fibrillation (AF) ablation and can be achieved by a variety of technical methodes. While thermal ablation modalities (TA), such as cryoballon (CB) and radiofrequency ablation (RF) have been established as the standard approaches, PFA has been introduced as a nvel non-thermal modality showing comparable safety and procedural efficiency. Despite the high incidence of AF in heart failure (HF) patients, data comparing outcomes of HF patients undergoing PVI by either PFA or thermal ablation (RFA/CB) are limited. Purpose This study’s aim was to compare the efficacy and safety of PFA for AF ablation versus CB/RFA in HF patients. Methods Consecutive HF patients with preserved (HFpEF), mildly reduced (HFmrEF) and reduced (HFrEF) ejection fraction undergoing PVI for AF by either PFA or CB/RFA at our institution were included. The primary end-point was time to death or recurrence of AF. Secondary end-points were periprocedural complications and clinical and echocardiographic parameters. Results We included 140 HF patients who underwent PVI either by PFA (PFA group, 76 patients) or thermal ablation approaches (TA group, 64 patients). Our patients had a mean age of 69 years and were predominantly male (62%). There was no significant difference in the baseline characteristics and in the type of AF between both groups (42% with ParAF, 45% with PersAF) and 13% LSPersAF). The distribution of heart failure types was similar between both groups: HFpEF (PFA: 71%, TA: 75%), HFmrEF (PFA: 21%, TA: 20%) and HFrEF (PFA: 8 %, TA: 5%). After the 365-days follow-up period we observed no significant difference for the primary end-point between both groups (HR: 0.79, 95% CI 0.35-1.78; p=0.575). In total 58% of the PFA patients and 59% of the TA group were still free from AF. While symptom improvement was documented in both groups, patients in the PFA group showed significant improvement of left atrial volume index (p = 0.014), NT-pro BNP levels (p = 0.046), and left ventricular ejection fraction (LVEF) (p = 0.005). Conclusion In this study, PFA and thermal ablation modalities showed comparable results in terms of safety and procedural efficiency in patients with heart failure. Since previous studies have shown that HF patients with AF benefit from PVI using thermal ablation modalities, our results suggest that PFA might also be a promising ablation method in this vulnerable population, inducing left atrial reverse remodeling and thereby contributing to improvement of left ventricular systolic function.

Incidence, determinants, and impact of in-hospital complications during percutaneous patent foramen ovale closure

Abstract Introduction The incidence, types, determinants, and clinical impact of in-hospital complications after contemporary patent foramen ovale (PFO) percutaneous closure is unclear. Purpose To describe the incidence, types, determinants, and clinical impact of in-hospital complications after percutaneous PFO closure. Methods This study included consecutive patients undergoing PFO percutaneous closure for any indication in 18 centers in France and Italy from the ongoing AIR-FORCE registry. Periprocedural complications were collected, including death, bleeding, myocardial infarction (MI), supraventricular arrhythmia, pericardial effusion or tamponade, cardiac perforation, device embolization, intracardiac thrombus, venous thrombosis, atrioventricular block, brachial paraesthesia, oesophageal hematoma, and veno-arterial fistula. Determinants of periprocedural complications were evaluated using a logistic multivariate model. The clinical impact of periprocedural complications on cardiovascular events after discharge measured by the composite endpoint of death, stroke, transient ischemic attack, MI atrial arrhythmia, pulmonary embolism, deep veinous thrombosis, BARC ≥2 bleeding, or percutaneous or surgical re-intervention on the PFO) at longest follow-up was evaluated using a Cox model adjusted on age, sex, body mass index, diabetes mellitus, hypertension, dyslipidemia, and shunt severity prior to closure. Results We analyzed a total of 2,799 patients undergoing PFO closure with median age 50.7 [41.7-58.6] years and 57.9% male. A total of 109 (3.9% 95%CI 3.2%-4.7%) patients presented at least one in-hospital complication, the most frequent being supraventricular arrhythmia in 39 (1.4% 95%CI 1.0-1.9%) patients and BARC bleeding type ≥2 in 26 (0.9% 95%CI 0.6-1.4%) patients. Determinants of in-hospital complications were older age (per on year aOR 1.02 95%CI 1.01-1.04), diabetes mellitus (aOR 2.58 95%CI 1.36-4.89) and PFO closure for secondary prevention of an arterial embolic event (aOR 2.12 95%CI 1.18-3.82). With a median follow-up of 1.1 [0.3-3.1] years, the occurrence of an in-hospital complication was associated with an increased risk of cardiovascular events after discharge (aHR 1.90 95%CI 1.26-2.89) (Figure 1). Conclusions Although relatively rare, the occurrence of in-hospital complication during PFO percutaneous closure is associated with an increased risk of cardiovascular events in the year following the procedure.

Risk factors for delirium in patients aged 60 years and over with recent myocardial infarction

Abstract Introduction Delirium is a form of acute brain dysfunction and geriatric patients are particularly vulnerable to this health problem. Modifiable and unmodifiable risk factors may influence delirium appearance. Purpose The study aimed to assess the prevalence and characteristic of delirium risk factors in patients ≥ 60 years of age hospitalized due to acute myocardial infarction (AMI). Methods The study included 405 consecutive patients (mean age: 73.1[8.5], males: 248/61.2 %) hospitalized due to AMI divided and characterized according to the in-hospital delirium presence. The following sets of data were analysed: demographic data, length of hospitalization, type of AMI, coronary intervention, multimorbidity, accompanying symptoms, psychiatric conditions, and pharmacotherapy used. Results Of 405 patients, 57 (14%, mean age: 80.9[7.3] years, males: 33/58%) experienced delirium. Patients with delirium were older (80.9[7.3] vs 71.82[8.1] years), all of them presented multimorbidity, they more frequently used polypharmacy (96.5 vs 30.2%) and their hospitalization was longer (8.0[1.4] vs 4.6[1.0] days) as compared to the patients without delirium. Patients with delirium more frequently experience in-hospital reversible problems: periprocedural complications (limited number of radial access, prolonged compression and pain after the procedure, pseudoaneurysm of femoral artery, as well as the following accompanying symptoms: fever (40.4% vs 0.9%), infections (78.9% vs 3.7%), pulmonary oedema (73.7% vs 0.6%), hypoxemia (91.1% vs 98.3%), urinary catheter (96.5% vs 17.2%), dehydration (89.5% vs 6.6%), and insomnia (71.9% vs 0.3%) compared to patients without delirium (Table 1). Delirium was also associated with mild (49.1% vs 0.3%, p<0.0001) and moderate (47.4% vs 9.2%) dementia and symptoms of mild depression (59.6% vs 2.3%) (P<0.0001 for all). Valvular heart disease (OR=4.78; 95%CI: 1.10-2.70; p<0.0001, pulmonary oedema (OR=66.79; 95%CI: 12.04-370.34, p<0.001), and dehydration (OR=37.26; 95%CI: 10.50-132.27, p<0.001) were risk factors for delirium occurrence. Analysis of all factors related to delirium revealed that the coexistence of ≥ 11 concerned 44% of the delirium population (Table 1). Conclusions The in-hospital course of AMI is complicated by delirium occurrence in 14% of patients ≥ 60 years old. Multimorbidity and polypharmacy regard most of the subjects with delirium. The potent reversible complications of the in-hospital course of AMI associated with delirium should be recognized and limited to prevent this problem.Table1.Number of delirium risk factors.

Impact of left atrial appendage occlusion in atrial flow evaluated through 4D flow cardiac magnetic resonance

Abstract Introduction Device-related thrombus (DRT) and peri-device leak constitute significant complications following left atrial appendage occlusion (LAAO), primarily due to its association with strokes and thromboembolic events. Patient-specific fluid simulations have been employed to explore this hypothesis(1). However, these simulations require detailed anatomical and physiological data, rely on certain assumptions when defining boundary conditions, and involve long computational times. Recently, there has been growing interest in the use of 4D flow cardiac magnetic resonance (CMR) imaging for various cardiovascular diseases, owing to its capability to reproduce blood flow. While its role in the LAAO scenario has been evaluated in silico(2), there are no reported cases of its application in patients undergoing LAAO. Purpose Our objective was to evaluate the impact of LAAO in atrial flow through 4D flow CMR. Methods Five patients undergone LAAO were included in the pilot study. A pre- and 90-days post-procedure 4D flow CMR scans were performed. One of the patients was excluded due to suboptimal image quality. To assess the impact of LAAO on atrial flow dynamics, three parameters were evaluated: a) mean velocity, b) stasis velocity ratio, and c) endothelial cell activation potential (ECAP) index — all associated with an elevated risk of thrombus formation(3,4). Results Baseline and procedural characteristics, along with imaging results, are presented in Table 1. Preprocedural 4D flow CMR for all patients revealed low velocities (Figure 1A) and a high ECAP index (Figure 2A) in the left atrial appendage, indicating flow stasis and an elevated risk of thrombus formation. Successful device implantation was performed in all cases, and no periprocedural complications were detected. Postprocedural 4D flow CMR was feasible in all cases, and no artifacts were detected despite the presence of the LAAO device. An objective increase in velocities and a decrease in the ECAP index were observed in all cases following LAAO. No DRT or ischemic events were reported during follow-up. Conclusions Our preliminary study demonstrates that 4D flow CMR provides valuable information on left atrial flow dynamics following the LAAO procedure. Further studies are warranted to evaluate this promising technique.Table 1.Patient characteristicsFigure 1 and 2.Representative example

Predisposing and precipitating factors of post-operative delirium after transfemoral TAVI

Abstract Background Transcatheter aortic valve implantation (TAVI) represents the treatment of choice for aortic stenosis (AS) patients at higher age (> 75y) or with relevant comorbidities. Post-operative delirium (POD) is a frequent complication which has been associated with worse outcome. Thus, preventive options are highly needed. The aim of our single-center study was to investigate predisposing and precipitating factors of POD after transfemoral TAVI, with a focus on the influence of anaesthesia. Methods Risk factors for POD after TAVI were analysed in 2 merged cohorts of 480 study patients (43% women; mean age 80 years), enrolled in 2017-2022 (n=375, TAVI in 95% in general anaesthesia) and in 2022-2024 (n=105, TAVI in 91% in local anaesthesia). Incidence of POD was evaluated retrospectively by nursing documentation, medical records, and DRG coding. The association of demographics, comorbidities, echo parameters, procedural parameters, anaesthesia, and peri-procedural complications with POD incidence was investigated. Results In total, 29 patients (6%) developed POD, with a tendency towards a lower incidence in the later cohort (6.7% vs. 3.8%; p=0.28). Regarding baseline characteristics, patients experiencing POD were more likely to be male (p=0.03), frail (Katz Index <6, p=0.049), and to suffer from low-gradient AS (p=0.005 for paradoxical, p=0.02 for classical low-flow, low-gradient AS; see also fig. 1A). Total procedure time was significantly longer in patients with POD (median, 86 vs. 62 min, p=0.004; fig 1B), and a tendency towards a more frequent implantation of other than ballon-expandable valves could be observed (p=0.07). Concerning the role of anaesthesia, POD did not differ significantly after general anaesthesia (n=24/360, 6.7%), conscious sedation (n=1/19, 5.3%), and local anaesthesia (n=4/100, 4%) (p=0.38). Regarding procedural complications, POD patients were characterized by lower minimum hemoglobin post-TAVI (9.3 vs. 10.1 g/dl, p=0.05; fig. 1C) and higher incidences of intra-procedural resuscitation (11% vs. 2%, p=0.03), cerebrovascular accidents (10% vs. 2%, p=0.04) and new permanent pacemaker implantations (25% vs. 10%, p=0.02). In POD patients, long-term survival after TAVI was significantly reduced, with a median survival of only 2 years (Kaplan-Meier curves in fig. 2; p=0.001). Conclusions POD after TAVI stays common and unfavourable. The role of anaesthesia seems less pronounced than expected. Total procedure time and relevant anaemia after TAVI emerged as most important modifiable risk factors. Future research is warranted, since strategies to reduce precipitating factors for POD may have a significant impact on post-TAVI outcomes.Selected risk factors for PODConsequence of POD: Reduced Survival

Impact of comorbid coronary artery disease on short and medium-term outcomes after carotid artery stenting

Abstract Background Current recommendations acknowledge carotid artery disease as a clinical criteria for very high cardiovascular risk and carotid artery stenting (CAS) as one of the main therapeutic options for carotid artery stenosis. Carotid artery disease is often present in patients with coronary artery disease (CAD), presumably enhancing the cardiovascular risk of these patients. In this study, we aimed to appraise the prevalence and prognostic effects of comorbid CAD diagnosis in patients with significant carotid artery disease undergoing CAS. Methods We conducted a single-center retrospective analysis including consecutive patients that underwent CAS, between January 2007 and August 2023. Our main objective was to analyze the association of comorbid CAD in patients undergoing CAS, regarding 30-day major adverse cardiovascular events (MACE), 30-day global mortality, 1-year global mortality and major periprocedural complications. On a second perspective, we strived to identify if there was any modifiable factor that influenced worse outcomes in these populations, addressed by a Chi-Square Test. Data was collected by the medical team in our Centre, over the years of follow-up. Results A total of 380 patients were enrolled in this study, with a mean age of 72.1±8.3 years and no major differences concerning demographic characteristics. Based on the presence of previous CAD diagnosis, there was no statistical significance in 30-days MACE (p=0.442), 30-days global mortality (p=0.161), 1-year mortality (p=0.658) or periprocedural complications (p=0.062). Despite these results, there was a statistically significant difference in individuals with CAD and comorbid hypertension in 30-days CV death (p=0.002), 30-days global mortality (p=0.007) and 1-year global mortality (p=0.036). Conclusions Comorbid CAD in patients undergoing CAS due to carotid stenosis does not seem to be significantly associated with medium-term adverse events. Nevertheless, the results of this casuistry support the importance of rigorous blood pressure control in patients with significant carotid artery disease.Baseline CharacteristicsStudy outcomes

Association between in-hospital haemoglobin drop with or without overt bleeding and long-term clinical outcomes after percutaneous coronary intervention

Abstract Background Periprocedural bleeding complications remain a significant issue in patients undergoing percutaneous coronary intervention (PCI). Although most bleeding complications are defined by the degree of haemoglobin drop, prognostic implications of haemoglobin drop without clinically overt bleeding remain unclear. Purpose We aimed to investigate the association between haemoglobin drop after PCI and long-term prognosis, stratified by the occurrence of clinically overt bleeding. Methods Consecutive patients discharged after PCI between September 2008 to June 2018 from Keio Cardiovascular PCI multicenter prospective registry in Japan were analyzed. Patients were categorized into four groups: those with overt bleeding with haemoglobin drop, those with overt bleeding without haemoglobin drop, those without overt bleeding with haemoglobin drop, and those without overt bleeding nor haemoglobin drop. The pre- and post-PCI haemoglobin were defined as the lowest value within 72 hours before and after PCI. We defined the haemoglobin drop as the value obtained by subtracting the pre-PCI haemoglobin value from the post-PCI haemoglobin value equal to or greater than 3.0 g/dL. The primary outcome was the 2-year composite of major adverse cardiovascular events (MACE): all-cause mortality, acute coronary syndrome, heart failure hospitalization, or stroke. Cox proportional models were used to assess the association between the haemoglobin drop and the clinical outcomes. Results Among the 6,013 patients [mean age 68 years and 78% male], 52 (0.9%) had overt bleeding with haemoglobin drop, 45 (0.7%) had overt bleeding without haemoglobin drop, 497 (8.3%) had haemoglobin drop without overt bleeding, and 5,419 (90.1%) had neither. At the two-year follow-up, patients with overt bleeding, both with and without haemoglobin drop had higher rates of MACE compared to those without overt bleeding, with and without haemoglobin drop (28.8% vs. 20.0% vs. 11.8% vs. 10.5%, respectively). Patients with overt bleeding with haemoglobin drop were associated with increased risks of MACE compare to those without overt bleeding without haemoglobin drop (HR: 2.19, 95% CI: 1.26-3.81, P=0.01). Conversely, patients without overt bleeding with haemoglobin drop and patients with overt bleeding without haemoglobin drop were not associated with increased risk of MACE (HR:1.19, 95% CI: 0.88-1.63, P=0.26, and HR: 0.62, 95% CI: 0.29-1.31, P=0.21, respectively). The spline curve showed a significant correlation between haemoglobin drop and MACE in patients with overt bleeding. However, for patients without overt bleeding, the correlation was attenuated. Conclusions Patients with haemoglobin drop with overt bleeding were significantly associated with long-term prognosis, but no association was observed among those with haemoglobin drop without overt bleeding. Our findings prompt a reevaluation of the current criteria for classifying bleeding complications.Figure

Nationwide trends in utilization and safety of ventricular arrythmia ablation in patients with hypertrophic cardiomyopathy

Abstract Background Catheter ablation for ventricular arrhythmias, including ventricular tachycardia (VT) and premature ventricular complexes (PVC) is increasingly utilized across the nation, while data on its safety in Hypertrophic Cardiomyopathy (HCM) patients is sparse. Purpose To analyze the nationwide trends in utilization and complications of inpatient ventricular arrhythmia ablations in patients with HCM. Methods This study is a retrospective analysis of hospitalizations, in HCM patients 18 years of age and older, who underwent an inpatient VA ablation in the U.S., between 2016 and 2020. We drew data from the National Inpatient Sample (NIS) database. Patients without HCM undergoing the CA for VA were used as controls. Baseline sociodemographic and clinical data, procedural complications, mortality and length of stay were analyzed. Multivariable analysis was performed to identify independent predictors of procedural complications. Results Among a weighted total of 2880 patients hospitalized between 2016 and 2020, who underwent VA ablations, the median age was 67 years (IQR 56-74), 60% were male, and 73% were white. The HCM group had similar age distribution but more women (64.5% vs 33.6%, p<0.001) and more African Americans (13.2% vs. 7.3%, p=0.03). The non-HCM cohort had significantly higher rates of prior myocardial infarction (22% vs 12.4%, p=0.026), ischemic cardiomyopathy (30.1% vs 0.8%, p<0.001), heart failure (70.5% vs 39.7%, p<0.001), and peripheral vascular disease (PVD, 42.9% vs 18.2%, p<0.001). This was reflected in higher Deyo Comorbidity Index in the non-HCM cohort (score of ≥ 2 in 66.6% vs 43%, p<0.001). Overall, the real-world peri-procedural complication rate in the entire cohort was 15.3%, including 6.4% hemorrhagic, 4.5% pericardial, and 2.3% vascular complications. There was a trend for lower complication rate in the HCM group (9.9% vs. 16.7%, p = 0.08). The in-hospital mortality didn’t defer (1.7% vs. 4.2%, p=0.28) and the length of stay was shorter in the HCM group (3.5 vs. 6.4 days, p < 0.001). Multivariable logistic regression analysis showed obesity (OR 2.06; 95%CI: 1.59 - 2.67; p<0.001) and PVD (OR 2.19; 95%CI: 1.34-3.53; p=0.001) to be independent predictors of complications while HCM was not (OR 0.76, 95% CI 0.51-1.14, p = 0.195). Conclusion Real-world data from a nationwide inpatient database shows comparable safety for VA ablation in HCM patients with similar mortality and lower length of stay, compared to non-HCM patients.

Evaluation of efficacy and safety of simplified procedure for the percutaneous closure of patent foramen ovale: the Ile De France Foramen Ovale Permeable(IDFFOP) prospective, multicenter cohort study

Abstract The superiority of device closure over medical therapy for the prevention of recurrent stroke in patients with cryptogenic stroke and patent foramen ovale (PFO) was reported in several meta –analyses of randomized controlled trials. The growing number of PFO procedures requires to find alternatives to conventional guidance by transoesophageal echocardiography (TOE) needing general anesthesia. The aim of our study was to assess prospectively the efficacy and safety of a simplified procedure based on trans thoracic echocardiography (TTE) and local anesthesia rather than TOE during PFO closure. Methods Design and study oversight. The IDFFOP study was a French prospective, multicenter cohort study performed in four centers expert in TTE-guided device deployment. All patients had a stroke history, a PFO and a large or moderate right to left shunt defined by the number of microbubbles in the left atrium ( large shunt > 30, moderate : 10 to 30 microbubbles). A(Risk of Paradoxical Embolism) score>5 was required to confirm PFO imputability in stroke history. The primary end point was efficacy of TTE during the transcatheter PFO closure defined as the successful implantation of the device without malposition, without need of TOE, and absence of significant residual shunt at 3-month TTE control. Safety was defined as the absence of any periprocedural complications. Results 280 patients were enrolled from January 2018 to October 2020 ( male sex : 59.5%; Average age 57 years old ). Average ROPE score was 7; Cumulative immediate procedural success with the TTE-guided method was 99%, without any device embolization. However, in 2 patients, TOE was needed to guide device deployment. There was no severe vascular complication, or any ischaemic event during or after the procedure. 6 post-procedure groin hematomas occurred but none needed anyblood transfusion .One patient experienced a transient periprocedural atrial fibrillation. At 3 months there were only 8 (2,8%) residual right to left shunts (3 large, 5 moderate). Conclusion A simplified procedure for percutaneous PFO closure based on TTE and local anesthesia is safe and effective. Randomized controlled trials should be performed to confirm these results.

Transcatheter mitral edge-to-edge repair in patients with prior cancer diagnosis

Abstract Background Transcatheter edge-to-edge repair (TEER) is a safe and effective therapy for mitral regurgitation (MR). Despite oncological patients have an increased risk of functional and organic MR due to cardiotoxic treatment exposure, the use of TEER in this setting remains underexplored. Purpose To evaluate the safety and efficacy of TEER in patients with MR and prior cancer diagnosis. Methods Observational, retrospective, multicenter study based on the Spanish national TEER registry. Patients from those centers providing oncological specific data were included in this analysis. Patients with and without history of cancer were propensity score matched (PSM) in a 1:1 ratio. The primary efficacy outcome was a composite of death from any cause or unplanned hospitalization for heart failure at 1 year. Results A total of 1237 patients with MR who underwent TEER between 2010 and 2022 across 14 centers in Spain were included. The mean age was 73 ± 11 years and 34% were female. MR etiology was functional in 58%, organic in 27% and mixed in 15%. Of them, 164 had a history of cancer. Baseline characteristics of the unmatched cohort are shown in Figure 1. Median time from cancer diagnosis to TEER was 7 (3-17) years and the most common cancer types were breast (20%), leukemia/lymphoma (19%) and colorectal (11%). PSM resulted in 163 pairs with a good balance of baseline characteristics (Figure 1). Procedural success rate was high and similar between the groups (93% vs 96%, p=0.217), as were periprocedural complication rates (Figure 2A). The primary efficacy endpoint occurred in 38 (23%) patients in the cancer group and 29 (18%) patients in the control group (Hazard ratio 1.36, CI 95% 0.84 to 2.20, p= 0.214) (Figure 2B). Conclusion In routine practice, a notable proportion of patients undergoing mitral TEER have a prior cancer diagnosis. Immediate and 1-year clinical outcomes appear comparable to those observed in non-cancer patients. These findings suggest that mitral TEER should not be withheld from this growing population.

The impact of body mass index for atrial fibrillation ablation; real-world data on outcomes and quality of life

Abstract Background Pulmonary vein isolation (PVI) is a cornerstone in the management of atrial fibrillation (AF). Increasing numbers of overweight and obese patients undergo PVI, despite the association between a higher body mass index (BMI) and adverse ablation outcomes. The risks of perioperative complications and quality of life have hardly been studied for the different bodyweight groups. Purpose The purpose of this study is to clarify the impact of BMI on PVI outcomes, including both perioperative complications and change in quality of life after PVI. Methods This is an observational, multicentre cohort study of prospectively collected data, covering all 15 ablation centres in the Netherlands. The study included all patients who underwent their first catheter-PVI between January 2015 and December 2021. Patients with a BMI below 18.5 kg/m2, missing BMI data, or prior ablations were excluded. Patients were categorized by BMI; normal weight (BMI 18.5-24.9 kg/m2), overweight (BMI 25-29.9 kg/m2) and obesity (BMI ≥30 kg/m2). The primary outcome was repeat ablation within one year. A logistic regression model was used to adjust for patient characteristics. A generalized additive model was fitted to visualize the correlation between BMI and the risk of repeat ablation. Secondary outcomes were repeat ablation within 3 years, a composite of the periprocedural complications, and change in quality of life, assessed using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire before and at one year after PVI. Results A total of 20,725 patients (33% female) were included; 72% had a paroxysmal AF pattern. Of all patients, 30% were normal weight, 47% overweight and 23% obese. Within the first year post-index PVI, obese patients had a higher incidence of repeat ablation than normal-weighing and overweight patients (17.8% versus 15.6% and 16.1%, P <0.05). Obesity independently predicted an increased risk of repeat ablation within 1 year (odds ratio 1.15; 95%-confidence interval 1.01-1.31, P =0.03). This increased risk was also apparent for repeat ablations within 3 years (hazards ratio 1.15; 95%-confidence interval 1.06-1.25; P <0.01). The composite complication rate was 3.8% in normal weighing, 3.0% in overweight, and 4.6% in obese patients, with weight class not being an independent predictor. All weight groups had a substantial improvement in quality of life one year after ablation. Post PVI, summarized AFEQT score was still lower in obese patients (81), than in normal weight (88; P <0.01) and overweight patients (88; P <0.01). Conclusions In a nation-wide contemporary cohort, obesity is an independent predictor for undergoing a repeat ablation within both 1 and 3 years. This relation is not apparent for overweight individuals. Catheter ablation can safely be performed in all weight classes. Despite an overall lower quality of life among obese individuals, substantial improvements in quality of life occur in all weight groups.Visual abstract

Conduction-System pacing Italian Network Group (C-SING): insights from a Nationwide Multicenter Observational Study

Abstract Background/Introduction Conduction system pacing (CSP), encompassing His bundle pacing (HBP) and left bundle branch area pacing (LBBAP), has gained prominence in treating bradycardia and heart failure in recent years. Despite its increasing utilization, data on real-world adoption of CSP are limited. Purpose The C-SING study aimed at assessing patient characteristics, implant success, procedural details, and safety of CSP when performed in routine clinical practice. Methods Periprocedural data from 27 experienced CSP centers across Italy were collected on patients undergoing CSP implantation for various indications between January 2021 and January 2024. Results The study comprised 1,317 patients (median age 78 years [interquartile range, 71-83], male 66.2%). Leading indications included atrioventricular (AV) block (40.8%), sinus node dysfunction (12.1%), atrial fibrillation with bradycardia (9.7%), AV node ablation (9.5%), and heart failure (12.5%). Pacemakers were implanted in 77.3% of patients, cardiac resynchronization devices in 21.7%, and implantable cardioverter-defibrillators in 1.0%. Stylet-driven and lumenless CSP leads were utilized in 64.7% and 35.3% of procedures, respectively. Final 12-lead ECG assessment revealed LBBAP capture in 88.7% patients, HBP in 8.4% (selective 4.2%, non-selective 4.2%), and no CSP capture in 3.0%, resulting in a 97.0% CSP lead implantation success rate. In patients with LBBAP, predominant capture types were left bundle branch pacing (19.6%), left posterior fascicular pacing (19.2%), and left septal fascicular pacing (14.8%). Comparing HBP to LBBAP, the latter showed shorter procedural time (60 minutes [45-80] vs. 70 minutes [60-95], p=0.003), but similar fluoroscopy time (6.0 minutes [3.3-10.8] vs. 6.1 minutes [4-10], p=0.735). Paced QRS duration was longer in LBBAP (118 ms [105-130]) compared to HBP (110 ms [101-122], p<0.001). LBBAP showed lower capture thresholds (0.6 V [0.5-0.9] @0.4 ms vs. 0.8 V [0.5-1.5] @1.0 ms, p<0.001) and higher R-wave sensing (10.7 mV [8-16] vs. 4.5 mV [2.4-9.9], p<0.001). The rate of periprocedural complications was higher in patients with LBBAP than HBP (7.3% vs. 1.8%, p=0.03), with the most frequent events being intraprocedural perforation into the left ventricular cavity during lead screwing (2.6%) and CSP lead dislodgment before hospital discharge (1.4%). These occurrences necessitated lead repositioning without additional complications. Conclusion CSP demonstrated feasibility as a primary pacing strategy for various indications in a real-world, multicenter setting. LBBAP, more frequently used than HBP, exhibited shorter procedural time and superior acute electrical parameters. LBBAP revealed a higher rate of minor procedural complications than HBP. Further investigations, supported by additional long-term outcome data, are essential to comprehensively assess CSP performance.