Background The occurrence of frozen or stuck leaflet during transcatheter aortic valve implantation (TAVI) is a rare but potentially fatal complication. Case Summary An 83-year-old man was referred to an Italian Cardiology Unit for symptomatic severe aortic stenosis. The patient underwent transfemoral TAVI with a 26-mm Myval balloon-expandable valve. After deployment, severe aortic regurgitation was revealed by aortography. Transesophageal echocardiography showed hypomobility of one of the 3 leaflets. Unsuccessful attempts to restore mobility were made using a pigtail catheter and performing postdilation, requiring a valve-in-valve procedure, without any hemodynamic compromise. Discussion Anatomical and procedural factors may be responsible for frozen leaflet during TAVI, predominantly reported with balloon-expandable valves. Transesophageal echocardiography enables rapid recognition, while angiography alone may be insufficient. A prompt hemodynamic support could be also required to avoid adverse procedural outcomes. Conclusions A structured intervention algorithm and timely multidisciplinary involvement is essential to optimize outcomes in this high-risk situation.

BACKGROUND:Drug-coated balloon (DCB) percutaneous coronary intervention (PCI) for de-novo lesions represents a valid alternative to drug-eluting-stents in different settings. Bail-out stenting (BOS) might be applied to manage acute vessel recoil or dissections, however, its impact on clinical endpoints remains unclear. This study sought to investigate the 1-year outcomes of BOS compared to DCB-only PCI. METHODS:The present study was a multicenter, ambispective, investigator-initiated all-comer study enrolling PCI patients treated with DCB at 11 hospitals. Patients were divided into two groups: those who received DCB-only treatment and those who required BOS. Primary endpoint was 12-month target-vessel-failure (TVF) defined as a composite of target-vessel-myocardial infarction (TV-MI) and ischemia driven-target vessel revascularization (ID-TVR). RESULTS:The study included 1085 patients and 1236 lesions. BOS occurred in 11.1% of patients. The two study groups were well balanced in terms of clinical characteristics and angiographic features. Most of the lesions involved small vessels (median RVD 2.5 mm [IQR 2.0-2.5 mm]) and were classified as intermediate-high anatomical complexity (41% type B2/C). At 12-month, the occurrence of TVF was 3.2%. The primary endpoint occurred more frequently in BOS group (6.7% vs 2.8%, p-value = 0.02;), mostly due to TV-MI (4.2% vs 0.9%, p-value = 0.01). On multivariable analysis, BOS was still independently associated with the risk of the primary endpoint. (HR 2.70; 95%CI: 1.22-5.98: p-value = 0.015). CONCLUSIONS:After DCB-PCI the need for bail-out stenting is an independent risk factor of TVF at 1 year. Operators should anticipate BOS as a higher-risk scenario, imaging optimization may mitigate risks.

In many countries, patients’ access to transcatheter aortic valve implantation (TAVI) is limited by reimbursement issues or delayed admission to heart valve centers, thus increasing the risk of adverse events in wait-listed patients. The TAVI AT HOME (TAH) is a single-arm, multicenter study aiming to evaluate the safety and efficacy of transfemoral TAVI performed at centers without on-site cardiac surgery by expert operators. The primary endpoint is 30-day all-cause mortality. This study focuses on the run-in phase of the registry, which was required by the ethics committee to perform an interim safety analysis. The outcome of 20 TAH patients enrolled at three Italian centers from May 2023 to May 2024 was compared to 41 TAVI cases included in the permanent local registry, matching the TAH inclusion/exclusion criteria. The two groups had similar baseline characteristics. Significantly more patients in the TAH group were deemed at prohibitive risk (85.0% vs. 56.1%; p = 0.026) but had similar surgical risk scores. A self-expanding device was used in most cases (60.7%). Technical success did not differ between groups (95.0% in the TAH vs. 85.4%, p = 0.409). No deaths at 30 days (primary endpoint) were observed. The 1-year survival rate did not differ between groups. After interim data analysis, the ethics committee authorized the completion of the TAH enrollment and extension to other centers. The TAH approach might represent an alternative model to allow timely access to TAVI without compromising safety and effectiveness.

OBJECTIVES:We describe the endovascular management of multiple vessel-related complications in a case of transcatheter aortic valve replacement (TAVR) through surgical right transaxillary access. KEY STEPS:We present the case of a TAVR performed through the right transaxillary approach and detail the treatment of an early subclavian dissection and a subacute subclavian pseudoaneurysm, successfully managed through endovascular interventions. POTENTIAL PITFALLS:Significant subclavian disease can raise the questions whether to prepare the vessel before the procedure and whether to proceed sheathless with the valve delivery system or use a larger fixed introducer. Additionally, the decision to treat or not treat early vessel complications may lead to different outcomes. TAKE-HOME MESSAGES:The right transaxillary approach for TAVR is a feasible alternative access, although vascular injuries can occur. A subclavian pseudoaneurysm can be addressed with percutaneous intervention. In this scenario, loss of the ipsilateral vertebral artery can be tolerated without serious consequences.

Transcatheter aortic valve implantation (TAVI) has become the standard of care for elderly patients with aortic stenosis. International guidelines recommend that TAVI should be performed only in centers with on-site cardiac surgery (CS). However, rapidly evolving TAVI technology and increasing operator expertise have significantly reduced peri-procedural complications, including those requiring rescue surgery, which occur in less than 0.5% of cases. Furthermore, only a minority of major complications are treated with CS, and the outcomes remain unfavorable. TAVI in centers without CS could represent a solution to reduce waiting times and ensure continuity of care for fragile patients. “TAVI at Home” is a single-arm prospective interventional study. According to sample size calculations based on literature data, the study aims to enroll a total of 200 patients, beginning with a run-in phase of 20 patients to establish safety. The primary endpoint is 30-day all-cause mortality. Secondary endpoints include technical success and the evaluation of single complications 30 days after the procedure. Hospitals without CS that are eligible to perform TAVI must have a high volume of coronary percutaneous interventions, operators with established TAVI experience, collaboration with vascular surgeons, and regular Heart Team meetings to ensure rigorous patient selection.

BACKGROUND:There is little data on the outcome of balloon aortic valvuloplasty (BAV) in relation to valve dimensions and calcification patterns. The procedure is not standardized, particularly the choice of balloon size. METHODS:This retrospective multicenter study focused on BAV efficacy and safety by analyzing the relationship between balloon size, annulus geometry (i.e., diameters, perimeter, and area), and calcification patterns (total burden and calcium distribution over each individual leaflet). From March 2018 to March 2023, all consecutive patients who underwent clinically indicated BAV and ECG-gated multidetector computed tomography of the aorta were included, except those with a bicuspid valve. Calcium score was calculated on contrast-enhanced images based on a luminal attenuation threshold of +100 HU. RESULTS:One hundred and fifteen patients were included. Procedural success was 82.6 %. The balloon-to-annulus ratio (BAR) relative to diameter, perimeter, and area was higher in patients with successful BAV. Patients with unsuccessful BAV had a significantly higher aortic valve calcium burden. The complication rate was 4.3 % and there was no association with valve geometry or calcium burden. A trend towards a reduced complication rate was found as calcium asymmetry increased. BAR minimum annulus diameter was the best parameter in predicting procedural success, with a cut-off at 0.85. CONCLUSIONS:BAV efficacy is correlated directly with balloon size in relation to annulus dimension and inversely with total calcium burden. The minimum diameter of the valve may be adopted as a reference for balloon sizing.

Even if un to improve long-term prognosis, balloon aortic valvuloplasty (BAV) may be useful in selected patients with symptomatic severe aortic stenosis either as a bridge to surgical or transcatheter valve replacement (aortic valve replacement [AVR] or transcatheter aortic valve implantation [TAVI]) or as a triage strategy for patients with uncertain indications. International guidelines recommend BAV as: a "bridge" to AVR/TAVI, a "trial" in patients with undetermined symptoms, or a "bridge-to-decision" in case of comorbidities. However, in clinical practice, BAV is also used as a palliative measure to improve hemodynamics and quality of life in many patients who are excluded from AVR/TAVI. Finally, BAV is often performed during TAVI to facilitate prosthesis delivery, optimize frame expansion, or for bioprosthetic valve fracture in selected valve-in-valve procedures. Technical innovations, which allow for a mini-invasive approach via transradial access and pacing delivered through the wire, have led to a decrease in complications over time. This review focuses on contemporary BAV with a specific emphasis on new indications, innovative techniques, and specific complex patient subgroups.

ObjectiveThe study was designed to: (1) confirm safety and feasibility of mini-invasive radial balloon aortic valvuloplasty (BAV); (2) assess its impact in terms of quality of life and frailty; and (3) evaluate whether changes in frailty after BAV are associated with death in patients undergoing transcatheter aortic valve implantation (TAVI).Methods330 patients undergoing BAV in 16 Italian centres were prospectively included. The primary endpoint was the occurrence of major and minor Valve Academic Research Consortium (VARC)-2 bleeding. Secondary endpoints were scales of quality of life, frailty, evaluated at baseline and 30 days, and their relationship with the occurrence of all-cause death.ResultsBAV was performed by radial access in 314 (95%) patients. No VARC-2 major and six (1.8%) VARC-2 minor bleedings occurred in the study population. Quality of life, as well as frailty status, significantly improved 30 days after BAV. At 1 year, patients undergoing TAVI with baseline essential frailty toolset (EFT) <3 or achieving an EFT <3 after BAV had a comparable occurrence of all-cause death (15% vs 19%, p=0.58). On the contrary, patients with EFT ≥3 at 30 days despite BAV showed the worst prognosis (all-cause death: 40% vs 15% and 19%, p=0.006 and p=0.05, respectively).ConclusionsMini-invasive radial BAV is safe, feasible and associated with a low rate of vascular complications. Patients improving EFT 30 days after BAV showed a favourable outcome after TAVI.Trial registration numberNCT03087552.

Aims The purpose of this study was to verify the impact on the number and characteristics of coronary invasive procedures for acute coronary syndrome (ACS) of two hub centers with cardiac catheterization facilities, during the first month of lockdown following the COVID-19 pandemic. Materials and methods Procedural data of ACS patients admitted between 10 March and 10 April 2020 were compared with those of the same period of 2019. Results We observed a 23.4% reduction in ACS admissions during 2020, with a decrease for both ST-elevation myocardial infarction (STEMI) (–5.6%) and non-ST-elevation myocardial infarction (–34.5%), albeit not statistically significant ( P = 0.2). During the first 15 days of the examined periods, the reduction in ACS admissions reached 52.5% (–25% for STEMI and –70.3% for non-ST-elevation myocardial infarction, P = 0.04). Among STEMI patients, the rate of those with a time delay from symptoms onset longer than 180 min was significantly higher during the lockdown period ( P = 0.01). Radiograph exposure ( P = 0.01) was higher in STEMI patients treated in 2020 with a slightly higher amount of contrast medium ( P = 0.1) and number of stents implanted ( P = 0.1), whereas the number of treated vessels was reduced ( P = 0.03). Percutaneous coronary intervention procedural success and in-hospital mortality were not different between the two groups and in STEMI patients ( P NS for all). Conclusion During the early phase, the COVID-19 outbreak was associated with a lower rate of admissions for ACS, with a substantial impact on the time delay presentation of STEMI patients, but apparently without affecting the in-hospital outcomes.

Razionale. Gli scaffold vascolari bioriassorbibili (BRS) rappresentano l’ultima evoluzione del trattamento interventistico della malattia aterosclerotica coronarica. Nel novembre del 2013, quando dei tre BRS attualmente presenti sul mercato solo il dispositivo Absorb BVS era disponibile, la Commissione Regionale Dispositivi Medici e la Commissione Cardiologica e Cardiochirurgica della Regione Emilia-Romagna hanno redatto una valutazione tecnico-scientifica. Il documento era finalizzato a fornire indicazioni per l’introduzione dei BVS nella pratica clinica. Sono state individuate 5 indicazioni preferenziali: lesioni coronariche lunghe (>28 mm), pazienti con lesioni ostiali (escluso tronco comune), rivascolarizzazione completa in pazienti di età <50 anni, patologia diffusa (>40 mm) o coinvolgente il tratto medio-distale del ramo discendente anteriore in pazienti con età <70 anni, dissezione coronarica spontanea.Materiali e metodi. L’analisi raccoglie i dati sull’utilizzo dei BRS provenienti dai laboratori di emodinamica della Regione Emilia-Romagna. Risultati. In un periodo di 3 anni sono stati impiantati 546 BRS in 328 pazienti, che corrispondono all’1.5% del totale degli stent medicati (DES) utilizzati, con un trend in progressiva crescita (0.3% nel 2013, 0.9% nel 2014, 3.2% nel 2015). Le indicazioni inizialmente promosse sono state seguite in 200/328 (61.0% dei pazienti, di cui un terzo ne possedeva più d’una) tra le quali principalmente: trattamento di lesioni lunghe in rami di calibro >2.5 mm (67%), pazienti giovani (31.5%), tratto medio-distale del ramo discendente anteriore (28%). Le indicazioni cliniche sono state: infarto miocardico con sopraslivellamento del tratto ST in 74 pazienti (22.6%), sindrome coronarica acuta senza sopraslivellamento del tratto ST in 129 (39.3%), coronaropatia stabile in 94 (28.7%). L’imaging intracoronarico (ecografia intravascolare) è stato utilizzato nel 24.7% dei casi. In 85 procedure (25.9%) è stata eseguita una rivascolarizzazione ibrida con utilizzo combinato di BRS e DES.Conclusioni. L’impiego dei BRS è stato inferiore alle aspettative, con discreta variabilità tra i Centri e seguendo le indicazioni regionali nella maggioranza dei casi. Il basso utilizzo potrebbe essere dovuto alla prudenza degli operatori nella loro iniziale esperienza. Il progressivo aumento nell’impiego dei BRS sembra rivelare una maggiore confidenza nella tecnica di impianto e fiducia nell’interezza dei dati pubblicati circa la sicurezza ed efficacia del dispositivo.

BACKGROUND:The bioresorbable vascular scaffold (BRS) technology constitutes the new revolution of the coronary artery disease interventional treatment. Currently, three distinct types of BRSs are available but only one, the Absorb BVS, was on the market in 2013 when the Regional Commission for Medical Devices and the Cardiology and Cardiac Surgery Commission of the Emilia-Romagna Region drew up a technical and scientific essay to provide guidance for the introduction of BRS in public and affiliated health facilities. Five preferential indications were given for use: long coronary lesions (>28 mm), ostial lesions (left main stem excluded), complete revascularization in patients aged <50 years, diffuse disease (>40 mm) or involving the mid/distal left anterior descending (LAD) branch in patients <70 years, spontaneous coronary artery dissection. METHODS:This survey analyzed data from all the catheterization laboratories in the Emilia-Romagna Region, merged in a unified database. RESULTS:In a 3-year study period, 546 BRS were implanted in 328 patients, corresponding to 1.5% of the drug-eluting stents (DES) used, with a trend towards a progressive increase over time. Initial indications were followed in 200/328 (61.0%) patients (about one third fitting more indications), mainly for treatment of long lesions in vessels >2.5 mm (67%), young patients (31.5%) and mid/distal LAD (28%). In 22.6% of cases the clinical scenario was a ST-segment elevation myocardial infarction, in 39.3% a non-ST-segment elevation acute coronary syndrome. Intracoronary imaging was infrequently used (intravascular ultrasound in 24.7% of cases). In 85 patients (25.9%) a hybrid procedure (BVS/DES) was performed. CONCLUSIONS:BRS use has resulted lower than expected, with discrete variability among centers, but according to the initial indications of the Emilia-Romagna Region in the majority of cases. The underuse might have been due to operators' caution in their initial experience. However, the increasing trend may reveal a greater confidence in the implantation technique and the whole amount of safety and efficacy data.

BACKGROUND:The aim of this study was to assess in-hospital and long-term results of the novo unprotected left main (UPLM) percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS) or stable coronary artery disease (CAD), in an unselected population admitted to a single high- volume cath-lab without on-site cardiac surgery. METHODS:From 2008 to 2011, among 317 PCI performed in patients with the novo UPLM stenosis, 49 patients presented ST-elevation myocardial infarction (STEMI), 152 non ST-elevation MI/unstable angina (NSTEMI/UA), 116 stable CAD. RESULTS:In-hospital mortality was 20% in STEMI, 5.3% in NSTEMI/UA and 1.7% in stable CAD patients (P<0.001). Two-year total mortality was 24.5%, 25.6% and 6% in the 3 groups, and cardiac death was 20%, 13.8% and 3.4% (P=0.002). Left main target lesion revascularization (TLR) was similar in the 3 groups, as the clinically-driven TLR (10% vs. 11% vs. 7.7%, P=0.642), with neither definite nor probable stent thrombosis. Multivariate analysis showed the following independent predictors of 2-year mortality: bare-metal stent use (OR 4.53, P<0.001), Syntax Score >32 (OR 3.53, P=0.012), ACS as the indication (OR 3.24, P=0.012), peripheral artery disease (OR 2.20, P=0.042), and age >75 years (OR 2.09, P=0.05). CONCLUSIONS:Our experience showed acceptable results of UPLM PCI in STEMI patients, where short-term prognosis was related to hemodynamic conditions, good results in NSTEMI/UA patients where mortality increased in the follow-up due to comorbidities, and very good results in patients with stable CAD.

OBJECTIVES:to assess in-hospital and long-term results of the novo unprotected left main (UPLM) percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS) or stable coronary artery disease (CAD), in an unselected population admitted to a single high- volume cathlab without on-site cardiac surgery. METHODS:from 2008 to 2011, among 317 PCI performed in patients with the novo UPLM stenosis, 49 patients presented ST-elevation myocardial infarction (STEMI), 152 non ST-elevation MI/unstable angina (NSTEMI/UA), 116 stable CAD. RESULTS:in-hospital mortality was 20% in STEMI, 5.3% in NSTEMI/UA and 1.7% in stable CAD patients (p<0.001). Two-year total mortality was 24.5%, 25.6% and 6% in the 3 groups, and cardiac death was 20%, 13.8% and 3.4% (p=0.002). Left main target lesion revascularization (TLR) was similar in the 3 groups, as the clinically- driven TLR (10% vs 11% vs 7.7% , p= 0.642), with neither definite nor probable stent thrombosis. Multivariate analysis showed the following independent predictors of 2-year mortality: bare-metal stent use (OR 4.53, p<0.001), Syntax score >32 (OR 3.53, p=0.012), ACS as the indication (OR 3.24, p=0.012), peripheral artery disease (OR 2.20, p=0.042), and age > 75 years (OR 2.09, p=0.05). CONCLUSIONS:our experience showed acceptable results of UPLM PCI in STEMI patients, where short-term prognosis was related to hemodynamic conditions, good results in NSTEMI/UA patients where mortality increased in the follow-up due to comorbidities, and very good results in patients with stable CAD.

Percutaneous mechanical thrombectomy (PMT) for treatment of clinically significant pulmonary embolism (PE) has been shown to be technically feasible and effective, aiming at thrombus resolution without increase in major bleeding. Despite its success, use of PMT in clinical practise has not become widespread, because it is challenging. Among several devices proposed, AngioJet rheolytic thrombectomy (ART) appears as the most effective and easy-to-use. We present the case of a 69-year-old woman who developed acute intermediate-risk PE, with right ventricular dysfunction and major myocardial necrosis, who was successfully treated by ART. The peculiarities of the case, toghether with the principles, tecnique and tips and tricks of ART, its effectiveness and potential complications are discussed.

Acute ST-elevation myocardial infarction (STEMI) usually results from coronary atherosclerotic plaque disruption with superimposed thrombus formation. Detection of coronary thrombi is a poor prognostic indicator, which is mostly proportional to their size and composition. Particularly, intracoronary thrombi impair both epicardial blood flow and myocardial perfusion, by occluding major coronary arteries and causing distal embolization, respectively. Thus, although primary percutaneous coronary intervention is the preferred treatement strategy in STEMI setting, the associated use of adjunctive antithrombotic drugs and/or percutaneous thrombectomy is crucial to optimize therapy of STEMI patients, by improving either angiographical and clinical outcomes. This review article will focus on the prognostic significance of intracoronary thrombi and on current antithrombotic pharmacological and interventional strategies used in the setting of STEMI to manage thrombotic lesions.

Background: Percutaneous coronary intervention (PCI) has been increasingly employed to treat unprotected left main (ULM) stenosis, with hard endpoints similar to by-pass surgery, in patients selected by a Heart Team. Methods: From January 2008 to December 2011, 317 unselected and consecutive patients with de novo ULM stenosis underwent PCI with both bare metal (BMS) and drug-eluting (DES) stents. Major adverse cardiovascular events, target lesion (TLR) and vessel (TVR) revascularization were evaluated over a mean period of 590 ± 371 days. Results: Our population was characterized by a mean age 72 ± 10 years, high rate of acute coronary syndrome (ACS) (either with ST or non-ST elevation myocardial infarction, 15.5% and 35% respectively), severe comorbidity 16%, mean Euroscore 7 ± 3, mean Syntax Score 25 ± 9. In-hospital mortality was 6%. During the follow-up period, all-cause mortality was 16.7%, falling to 7% at the end of the follow-up, excluding patients presenting with ACS. TLR was observed and treated in 15% of patients. BMS utilization, age >75 years, ACS indication, Syntax Score >32 and associated peripheral artery disease were independent predictors of mortality at multivariate analysis. Conclusions: Stenting of ULM stenosis appears to be associated with a favorable mid-term outcome, even in an unselected population.