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Objective To evaluate the role of the microaxial percutaneous mechanical circulatory support device (Impella® pump) implantation pre‐percutaneous coronary intervention (PCI) versus during/after PCI in cardiogenic shock (CS) and high‐risk PCI populations. Background A better understanding of the safety and effectiveness of the Impella and the role of timing of this support initiation in specific clinical settings is of utmost clinical relevance. Methods A total of 365 patients treated with Impella 2.5/CP in the 17 centers of the IMP‐IT Registry were included. Through propensity‐score weighting (PSW) analysis, 1‐year clinical outcomes were assessed separately in CS and HR‐PCI patients, stratified by timing of Impella support. Results Pre‐procedural insertion was associated with an improvement in 1‐year survival in patients with CS due to acute myocardial infarction (AMI) treated with PCI (p = .04 before PSW, p = .009 after PSW) and HR‐PCI (p

Objectives The aim of this study was to describe baseline characteristics, and periprocedural and mid-term outcomes of patients undergoing transcatheter mitral valve interventions post-transcatheter aortic valve replacement (TAVR) and examine their clinical benefit. Background The optimal management of residual mitral regurgitation (MR) post-TAVR is challenging. Methods This was an international registry of 23 TAVR centers. Results In total, 106 of 24,178 patients (0.43%) underwent mitral interventions post-TAVR (100 staged, 6 concomitant), most commonly percutaneous edge-to-edge mitral valve repair (PMVR). The median interval post-TAVR was 164 days. Mean age was 79.5 ± 7.2 years, MR was >moderate in 97.2%, technical success was 99.1%, and 30-day device success rate was 88.7%. There were 18 periprocedural complications (16.9%) including 4 deaths. During a median follow-up of 464 days, the cumulative risk for 3-year mortality was 29.0%. MR grade and New York Heart Association (NYHA) functional class improved dramatically; at 1 year, MR was moderate or less in 90.9% of patients (mild or less in 69.1%), and 85.9% of patients were in NYHA functional class I/II. Staged PMVR was associated with lower mortality versus medical treatment (57.5% vs. 30.8%) in a propensity-matched cohort (n = 156), but this was not statistically significant (hazard ratio: 1.75; p = 0.05). Conclusions For patients who continue to have significant MR, remain symptomatic post-TAVR, and are anatomically suitable for transcatheter interventions, these interventions are feasible, safe, and associated with significant improvement in MR grade and NYHA functional class. These results apply mainly to PMVR. A staged PMVR strategy was associated with markedly lower mortality, but this was not statistically significant. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter Valve Registry [AMTRAC]; NCT04031274 )

BACKGROUND: The mean age of transcatheter aortic valve implantation (TAVI) patients is steadily decreasing. AIMS: The aim of the study was to describe the characteristics, the indications for and the outcomes of TAVI in patients 70). For patients 4% in 20.4%. Five-year mortality was similar (29.4 vs 29.8%, HR 0.95, p=0.432) in the 70 groups. In the

Background Although oral P2Y12 inhibitors are key in the management of patients with non-ST elevation acute coronary syndrome (NSTE-ACS), the optimal timing of their administration is not well defined. Objective to compare downstream and upstream oral P2Y12 inhibitors administration strategies in NSTE-ACS patients undergoing invasive management. Methods We performed a randomized, adaptive, open-label, multi-center, clinical trial. Patients were randomly assigned to receive pre-treatment with ticagrelor before angiography (upstream group) or no pre-treatment (downstream group). Patients in the downstream group undergoing percutaneous coronary intervention (PCI) were further randomized to receive ticagrelor or prasugrel. The primary hypothesis was superiority of the downstream over the upstream strategy on the combination of efficacy and safety events (net clinical benefit). Results We randomized 1449 patients to downstream or upstream oral P2Y12 inhibitor administration. A prespecified stopping rule for futility at interim analysis led the trial to be stopped. The rate of the primary endpoint, a composite of death due to vascular causes, non-fatal myocardial infarction or non-fatal stroke, and Bleeding Academic Research Consortium (BARC) type 3, 4 and 5 bleedings through day 30, did not differ significantly between the downstream and upstream groups (Absolute Risk Reduction (ARR%) -0.46 [-2.90; 1.90]).These results were confirmed among patients undergoing PCI (72% of population) and regardless of the timing of coronary angiography (within or after 24 hours from enrolment). Conclusions Downstream and upstream oral P2Y12 inhibitors administration strategies were associated with low incidence of ischemic and bleeding events and minimal numerical difference of event rates between treatment groups. These findings led to premature interruption of the trial and suggest the unlikelihood of enhanced efficacy of one strategy over the other. [Funded by the Italian Society of Interventional Cardiology (SICI-GISE)]

To overcome the not negligible metallic drug-eluting stents adverse events rate, the polymeric or metallic bioresorbable scaffolds were designed to provide early drug delivery and mechanical support followed by complete resorption. However, the long-term evidence, focusing on the leading Absorb BVS technology, showed higher events compared with drug-eluting stents. This review discusses the lights and shadows of the current bioresorbable scaffolds according to their mechanical properties and biodegradation profile and suggests possible perspective on these technologies. Improved scaffold design and deployment techniques might mitigate early bioresorbable scaffolds risk enhancing the late benefit of complete resorption.

Objective The aim of the study is to describe the real-world use of the P2Y12 inhibitor cangrelor as a bridging strategy in patients at high thrombotic risk after percutaneous coronary intervention (PCI) and referred to surgery requiring perioperative withdrawal of dual antiplatelet therapy (DAPT). Materials and Methods We collected data from nine Italian centers on patients with previous PCI who were still on DAPT and undergoing nondeferrable surgery requiring DAPT discontinuation. A perioperative standardized bridging protocol with cangrelor was used. Results Between December 2017 and April 2019, 24 patients (mean age 72 years; male 79%) were enrolled. All patients were at high thrombotic risk after PCI and required nondeferrable intermediate to high bleeding risk surgery requiring DAPT discontinuation (4.6 ± 1.7 days). Cangrelor infusion was started at a bridging dose (0.75 µg/kg/min) 3 days before planned surgery and was discontinued 6.6 ± 1.5 hours prior to surgical incision. In 55% of patients, cangrelor was resumed at 9 ± 6 hours following surgery for a mean of 39 ± 38 hours. One cardiac death was reported after 3 hours of cangrelor discontinuation prior to surgery. No ischemic outcomes occurred after surgery and up to 30-days follow-up. The mean hemoglobin drop was Conclusion Perioperative bridging therapy with cangrelor is a feasible approach for stented patients at high thrombotic risk and referred to surgery requiring DAPT discontinuation. Larger studies are warranted to support the safety of this strategy.

Transcatheter aortic valve implantation (TAVI) is the treatment of choice in patients with severe symptomatic aortic stenosis who are not suitable for surgery. The procedure has become the preferred strategy in patients at intermediate/high surgical risk with favourable clinical and anatomical characteristics. The collected scientific evidences, as well as the technologic innovations shaping the newer devices, allowed for a progressive reduction of the procedure-related complications as a well as a simplification of the procedure itself, promoting the gradual expansion of the indication for TAVI with the consequent increase in the estimated number of procedures performed each year. There are significant geographic and socio-economic disparities in the use of TAVI around the world and in Italy as well, reflecting an application of the procedure directly related to the economic prosperity of the Health System of the Country examined. The Italian situation, similar to the worldwide reality, reveals an uneven application of the procedure, signalling a disparity in the socio-economic and organizational capabilities of each single region. Standardization of patient selection for treatment, and of the clinical pathway for TAVI are crucial for an homogeneous integration of this new technology in the current Health Care System.

Myocarditis is an inflammatory heart muscle disease characterized by heterogeneous clinical presentation and outcome. Clinical heterogeneity of myocarditis, ranging from acute onset chest pain with electrocardiographic changes resembling an acute coronary syndrome, to arrhythmic storm and chronic decompensated heart failure, makes diagnosis challenging. However, a correct diagnosis is fundamental to proper patients' management and should always be seeked. Although a definite diagnosis is only provided by endomyocardial biopsy, the European Society of Cardiology task force on myocardial and pericardial diseases provided specific criteria for the diagnosis of clinically suspected myocarditis, which has been facilitated by the advent of noninvasive imaging tests (i.e. cardiovascular magnetic resonance based myocardial tissue characterization). Due to the heterogeneous presentation and disease course of myocarditis, a tailored treatment would be the best strategy, but a standardized management is still not available. However, over the years, new, promising therapies, such as antiviral and immune-suppressive treatment, have come side by side to the standard pharmacological heart treatment, i.e. antiheart failure medications. In this paper we will review the basic principles of myocarditis management in clinical practice, including diagnostic work-up, conventional and disease-specific therapy and patients' follow-up.

Background: Acute myocardial infarction-related cardiogenic shock (AMI-CS) still has high likelihood of in-hospital mortality. The only trial evidence currently available for the intra-aortic balloon pump showed no benefit of its routine use in AMI-CS. While a potential benefit of complete revascularisation has been suggested in urgent revascularisation, the CULPRIT-SHOCK trial demonstrated no benefit of multivessel compared to culprit-lesion only revascularisation in AMI-CS. However, mechanical circulatory support was only used in a minority of patients.Objectives: We hypothesised that more complete revascularisation facilitated by Impella support is related to lower mortality in AMI-CS patients.Methods: We analysed data from 202 consecutive Impella-treated AMI-CS patients at four European high-volume shock centres (age 66 ± 11 years, 83% male). Forty-seven percentage (n = 94) had cardiac arrest before Impella implantation. Revascularisation was categorised as incomplete if residual SYNTAX-score (rS) was >8.Results: Overall 30-day mortality was 47%. Mortality was higher when Impella was implanted post-PCI (Impella-post-PCI: 57%, Impella-pre-PCI: 38%, p = 0.0053) and if revascularisation was incomplete (rS ≤ 8: 37%, rS > 8: 56%, p = 0.0099). Patients with both pre-PCI Impella implantation and complete revascularisation had significantly lower mortality (33%) than those with incomplete revascularisation and implantation post PCI (72%, p < 0.001).Conclusions: Our retrospective analysis suggests that complete revascularisation supported by an Impella microaxial pump implanted prior to PCI is associated with lower mortality than incomplete revascularisation in patients with AMI-CS.

Objectives: The purpose of this study was to examine the impact of residual mitral regurgitation (MR) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR). Background: MR is common in patients undergoing TAVR. Data on optimal management of patients with significant MR after TAVR are limited. Methods: The registry consisted of 16 TAVR centers (n = 7,303). Outcomes of patients with ≥ moderate versus lesser grade MR after TAVR were compared. Results: In 1,983 (27.2%) patients, baseline MR grade was ≥ moderate. MR regressed in 874 (44.1%) patients and persisted in 1,109 (55.9%) after TAVR. Four-year mortality was higher for those with MR persistence, but not for those with MR regression after TAVR, compared with nonsignificant baseline MR (43.8% vs. 35.1% vs. 32.4%; hazard ratio [HR]: 1.38; p = 0.008; HR: 1.02; p = 0.383, respectively). New York Heart Association functional class III to IV after TAVR was more common in those with MR persistence vs. regression (14.4% vs. 3.9%; p < 0.001). In a propensity score–matched cohort (91 patients’ pairs), with significant residual MR after TAVR who did or did not undergo staged mitral intervention, staged intervention was associated with a better functional class through 1 year of follow-up (82.4% vs. 33.3% New York Heart Association functional class I or II; p < 0.001), and a numerically lower 4-year mortality, which was not statistically significant (64.6% vs. 37.5%; HR: 1.66; p = 0.097). Conclusions: Risk stratification based on improvement in MR and symptoms after TAVR can identify patients at increased mortality risk after TAVR. These patients may benefit from a staged transcatheter mitral intervention, but this requires further proof from future studies. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter [AMTRAC] Valve Registry [AMTRAC]; NCT04031274).

Percutaneous coronary intervention (PCI) is establishing as the last remaining revascularization option in an increasing number of patients affected by complex coronary artery disease not suitable for surgery. Over the past decade, percutaneous left ventricular assist device (pLVAD) has increasingly replaced intra-aortic balloon pump to provide hemodynamic support during such non-emergent complex high-risk indicated procedures (CHIP) averting the risk of circulatory collapse and of adverse events in long lasting and/or complicated procedures. This review article aims to report the key factors to define CHIP, to summarize the available pLVAD which have CE mark for temporary mechanical LV support and to discuss the rationale of their use in this subset of patients. Based on the expertise of the Italian Society of Interventional Cardiology working group, with the endorsement from Spanish and Portuguese Society of Interventional Cardiology working groups, it will provide several practical suggestions in regards to the use of pLVAD in different clinical CHIP scenarios.

Objectives The aim of this study was to explore the time course of survival advantage of TAVR over SAVR as function of the patients' risk and sex. Background Women have been reported to have better survival than men undergoing transcatheter aortic valve replacement (TAVR). However, scant data on the sex-based survival benefit of TAVR over surgical aortic valve replacement (SAVR) are available. Methods A systematic review of studies reporting clinical outcomes of men and women undergoing TAVR or SAVR was performed. Studies were divided into two groups according to average patient's risk score and the interplay of surgical risk and sex on outcomes were analyzed. Results Eight studies involving 6,596 women and 7,204 men patients were extracted. Unlike mens, women patients had survival advantage from TAVR over SAVR that became substantial at 1 year from index procedure and persisted at 2-year of follow-up. Moreover, this sex-based TAVR survival advantage was mainly observed in higher surgical risk patients. Men showed a significantly lower rate of residual paravalvular leak after SAVR. Conclusions Women patients had a selective mortality benefit from TAVR compared to SAVR. This sex-based TAVR benefit was mainly observed in high surgical risk patients beyond 1 year from procedure.

OBJECTIVES To evaluate the use and outcomes of percutaneous mechanical circulatory support (pMCS) utilized during transcatheter aortic valve implantation (TAVI) from high-volume centers. METHODS AND RESULTS Our international multicenter registry including 13 high-volume TAVI centers with 87 patients (76.5�������11.8���years, 63.2% men) who underwent TAVI for severe aortic stenosis and required pMCS (75.9% VA-ECMO, 19.5% Impella CP, 4.6% TandemHeart) during the procedure (prior to TAVI 39.1%, emergent rescue 50.6%, following TAVI 10.3%). The procedures were considered high-risk, with 50.6% having severe left ventricular dysfunction, 24.1% biventricular dysfunction, and 32.2% severe pulmonary hypertension. In-hospital and 1-year mortality were 27.5% and 49.4%, respectively. Patients with prophylactic hemodynamic support had lower periprocedural mortality compared to patients with rescue insertion of pMCS (log rank��=��0.013) and patients who did not undergo cardiopulmonary resuscitation during the TAVI procedure had better short and long term survival (log rank

In this review, we discuss about the reasons behind the failure of the Absorb bioresorbable vascular scaffold (BVS) device and about the challenges the future holds for the next generation of the bioresorbable scaffold (BRS) technology. Absorb BVS was burdened by intrinsic structural limitations which resulted in augmented rates of device thrombosis and clinical adverse events compared to current-generation metallic stent. Nevertheless, new generation devices with novel design and materials are in development. Second generation BRS have enhanced mechanical strength, smaller footprints, less thrombogenicity and modified bioresorption. These features, paired with proper patient and lesion selection and optimal “user-friendly” implant techniques, could possibly overcome the previous BRS generation limitations, rekindling physicians, and industry interest on this promising technology.

Background Women represent an increasing percentage of interventional cardiologists in Italy compared with other countries. However, gaps exist in understanding and adapting to the impact of these changing demographics. Methods and Results We performed a national survey to analyze demographics, gender‐based professional difference, needs in terms of catheterization laboratory (Cath‐Lab) abstention, and radiation safety issues in Italian Cath‐Lab settings. A survey supported by the Italian Society of Interventional Cardiology (Società Italiana di Cardiologia Interventistica–Gruppo Italiano di Studi Emodinamici SICI‐GISE) was mailed to all SICI‐GISE members. Categorical data were compared using the χ 2 test. P 10 years of Cath‐Lab experience. Notably, 26.4% were women. Workload was not gender‐influenced (women performed “on‐call” duty 69.8% versus men 68.3%; P =0.97). Women were more frequently unmarried (22.1% women versus 8.7% men; P =0.002) and childless (43.9% versus 56.1%; P P Conclusions Several gender‐based differences exist or are perceived to exist among interventional cardiologists in Italian Cath‐Labs. Joint strategies addressing Cath‐Lab abstention and radiation exposure education should be developed to promote gender equity in interventional cardiologists.

Background: Conduction disturbances after transcatheter aortic valve replacement (TAVR) are often transient. Limited data exist on anatomic factors predisposing to pacemaker dependency after TAVR. We sought to assess the rate and the possible predictors of pacemaker dependency after TAVR. Methods: Consecutive patients undergoing pacemaker implantation up to 30 days after TAVR between May 2014 and September 2019 were included. Baseline electrocardiographic, computed tomography, and procedural characteristics were collected, including valve implantation depth and membranous septum length, an anatomic surrogate of the distance between the aortic annulus and the His bundle. Pacemaker dependency at 30 days and 1 year and all-cause mortality during follow-up were evaluated. Results: Of 728 TAVR patients, 112 (53.5% men; median age, 81 years) underwent pacemaker implantation after TAVR. Of these, 44.6% (50 of 112) were pacemaker dependent at 30 days and 46.7% (36 of 77) at 1 year. By multivariate analysis, independent predictors of 30-day pacemaker dependency included left ventricular outflow tract calcifications under the left coronary cusp (odds ratio, 5.69 [95% CI, 1.45–22.31]; P =0.013) and a difference between membranous septum length and implantation depth (ΔMSID) ≥3 mm (odds ratio, 7.58 [95% CI, 2.07–27.78]; P =0.002). Conversely, membranous septum length and implantation depth alone were not associated with pacemaker dependency (odds ratio, 0.79 [95% CI, 0.60–1.05]; P =0.11 and odds ratio, 1.11 [95% CI, 0.99–1.24]; P =0.08). At a median follow-up of 28.1 (11.7–48.6) months, pacemaker-dependent patients did not show a worse survival ( P =0.26). Conclusions: Less than half of the patients undergoing pacemaker implantation after TAVR are pacemaker-dependent at midterm follow-up. ΔMSID ≥3 mm and the presence of left ventricular outflow tract calcifications under the left coronary cusp, but not membranous septum length nor implantation depth alone, are predictive of long-term pacemaker dependency after TAVR, thus influencing device selection and programming.

Background Women-specific data on safety, effectiveness, and outcomes for mechanical support in the setting of cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI) are still unsettled. The IMP-IT study was a multicenter observational national registry that enrolled all patients treated with Impella 2.5, Impella CP, Impella 5.0 and Impella RP, both for CS and HR-PCI indications, across 17 Italian centers from 2004 to June 2018 Purpose To analyze the characteristics of female population enrolled in IMP-IT registry and to assess differences in presentation, timing to interventions and outcomes between men and women. Methods The Women-IMP-IT study is a multicenter observational national registry focusing on female population enrolled in IMP-IT study. Baseline, procedural and hemodynamics characteristics, such as outcome were collected. Differences between men and women were examined. Results Mean age of female population was 66.9±16.1 years, Body mass index was 26.3±5.5 kg/m2. There was a higher rate of cardiogenic shock (66.7% vs. 49.1%; p=0.06), NSTEMI (18% vs 9%, p=0.03) and acute myocarditis (9.6% vs 1.4%, p=0.01) in women vs men, associated with a lower rate of protected PCI (33.3% vs 50.9%, p=0.06). We did not observed a statistically difference in device related complications (27.4% vs 23.3%; p=0.50), respectively in women compared to men. In particular, no differences were observed in access site bleedings (10.8% vs 9%; p=0.70) and life threatening or severe bleeding (15.3% vs 11.4%; p=0.40). At one year, all-cause death rate was 45.1% in women vs 30.1% in men (p=0.016), and cardiac death rate was 42.5% in women and 27.5% in men (p=0.013). At 1-year no significant difference was observed in the rate of myocardial infarction (3.7% vs 2.3%; p=0.44), stroke (3.7% vs 2.6%; p=0.70), heat-failure hospitalization (7.7% vs 7.5%; p=1.0), need for left ventricular assist device or heart transplantation (1.3% vs 5.5%; p=0.21). Conclusions In our series, use of Impella is CS and HR-PCI is increasing in female population. Sex-differences in mortality are mostly explained by clinical differences at presentation. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): EAPCI Education and Training Grants

Background Transcatheter aortic valve replacement (TAVR)‐in‐TAVR is a possible treatment for transcatheter heart valve ( THV ) degeneration. However, the displaced leaflets of the first THV will create a risk plane ( RP ) under which the passage of a coronary catheter will be impossible. The aim of our study was to evaluate the potential risk of impaired coronary access ( CA ) after TAVR ‐in‐ TAVR . Methods and Results We prospectively performed coronary angiography after TAVR with different THV s in 137 consecutive patients, looking where the catheter crossed the valve frame. If coronary cannulation was achieved from below the RP , the distance between valve frame and aortic wall was measured by aortic angiography. CA after TAVR ‐in‐ TAVR was defined as feasible if the catheter passed above the RP , as theoretically feasible if passed under the RP with valve‐to‐aorta distance >2 mm, and as unfeasible if passed under the RP with valve‐to‐aorta distance ≤2 mm. Seventy‐two patients (53%) received a Sapien 3 THV, 26 (19%) received an Evolut Pro/R THV, and 39 (28%) received an Acurate Neo THV . CA after TAVR ‐in‐ TAVR was considered feasible in 40.9% (68.1%, 19.2%, and 5.1%, respectively; P P P =0.116). Independent predictors of impaired CA after TAVR ‐in‐ TAVR were female sex (odds ratio [OR], 3.99; 95% CI , 1.07–14.86; P =0.040), sinotubular junction diameter (OR, 0.62; 95% CI , 0.48–0.80; P THV (OR, 6.61; 95% CI , 1.98–22.03; P =0.002). Conclusions CA after TAVR ‐in‐ TAVR might be unfeasible in >30% of patients currently treated with TAVR . Patients with a small sinotubular junction and those who received a supra‐annular THV are at highest risk of potential CA impairment with TAVR ‐in‐ TAVR .

Valvular heart disease (VHD) is encountered in approximately 1% of pregnancies, significantly increasing both maternal and foetal risk. Rheumatic VHD remains the most common form in non-Western countries, whereas congenital heart disease dominates in the Western world. The risk of complications varies according to the type and severity of the underlying VHD. Moreover, pregnancy is a hypercoagulable state associated with increased risk of thromboembolism. The authors review the main VHDs encountered during pregnancy, and suggest management strategies based on the 2018 European Society of Cardiology recommendations for the management of pregnant women with VHD, providing an overview of classical and new transcatheter structural therapeutic options with a special focus on radiation exposure and anticoagulation drug management.

Background Available scientific evidence of transcatheter mitral valve repair with the MitraClip comes from randomized controlled trials, which showed controversial results that hardly translate into real-world practice, and from registries of relatively small sample size. Aim To collect real-world data in a multicenter, prospective, country-level registry. Methods and result The Italian Society of Interventional Cardiology (GIse) Registry Of Transcatheter Treatment of Mitral Valve RegurgitaTiOn (GIOTTO) is an ongoing single-arm, multicenter, prospective registry that started enrollment in February 2016. Clinical end points were defined according to the Mitral Valve Academic Research Consortium (MVARC) criteria. From February 2016 to December 2018, 1189 patients (mean age 76 ± 9.1 years) were enrolled. The main MR etiology was functional (64.9%). MVARC technical success was 96.6%. At 30-day follow-up ( n = 1131), MVARC device and procedural success were 92.5% and 87% respectively, and all-cause death was 3%. The majority of patients who died at 30-day had functional MR (69.7%). Mixed etiology (OR 0.94, 95% CI 0.02–0.61) and prolonged length of stay in ICU (OR 0.97, 95% CI 0.95–0.99) were found to be negative independent predictors of device success at 30-day. The EuroSCORE II (OR 0.96, 95% CI 0.93–0.99), LVEDV-I (OR 0.99, 95% CI 0.98–0.99) and prolonged length of stay in ICU (OR 0.98, 95% CI 0.97–0.99) were negative independent factors of MVARC procedural success at 30-day. Conclusions The GIOTTO registry is one of the largest prospective registries available on MitraClip and shows favorable acute and 30-day safety and efficacy.

BACKGROUND Patients with small vessel disease (SVD) are at higher risk of adverse events after PCI compared to non-SVD patients. In this subset, the use of bioresorbable vascular scaffolds (BVS) has raised particular concern. OBJECTIVE We aimed to compare outcomes of Absorb BVS versus a 2nd-generation metallic everolimus-eluting stents (EES) in the SVD setting, by pooling patients from three large, prospective studies. METHODS Patients with SVD (reference vessel diameter ≤2.75 mm by QCA) and treated with Absorb BVS were identified in the Italian RAI and the MAASSTAD-Absorb registries. EES controls were identified in the COMPARE II Trial. We performed a propensity-score matching using several clinical and angiographic variables. Implantation technique was not object of matching, being device-specific. RESULTS Out of 4635 enrolled subjects, 1147 belonged to the SVD population. After matching, we obtained 337 pairs of patients. High clinical and angiographic complexity was found in both groups. Predilation and postdilation rates were significantly higher in BVS patients. No differences were found in terms of the device-oriented composite end-point at 1-year (HR = 1.08, 95%CI 0.5-2.3, P = .8) and 2-years (HR = 1.28, 95% CI: 0.68-2.43, P = .5). Notwithstanding, higher incidence of definite/probable stent thrombosis was observed in the BVS group at 1 year (HR 4.7, 95%CI 0.8-31.4, P = .08) and 2-years (HR = 8.34 95%CI 1.1-60.2, P = .04). CONCLUSION In this propensity-matched analysis pooling SVD patients of three large prospective studies, incidence of composite device-related events was comparable between BVS and EES up to 2 years follow-up. However, higher rates of stent thrombosis were found in the BVS group.

Perioperative management of antithrombotic therapy in patients treated with coronary stents undergoing surgery remains poorly defined. Importantly, surgery represents a common reason for premature treatment discontinuation, which is associated with an increased risk in mortality and major adverse cardiac events. However, maintaining antithrombotic therapy to minimize the incidence of perioperative ischemic complications may increase the risk of bleeding complications. Although guidelines provide some recommendations with respect to the perioperative management of antithrombotic therapy, these have been largely developed according to the thrombotic risk of the patient and a definition of the hemorrhagic risk specific to each surgical procedure, key to defining the trade-off between ischemia and bleeding, is not provided. These observations underscore the need for a multidisciplinary collaboration among cardiologists, anesthesiologists, hematologists and surgeons to reach this goal. The present document is an update on practical recommendations for standardizing management of antithrombotic therapy management in patients treated with coronary stents (Surgery After Stenting 2) in various types of surgery according to the predicted individual risk of thrombotic complications against the anticipated risk of surgical bleeding complications. Cardiologists defined the thrombotic risk using a "combined ischemic risk" approach, while surgeons classified surgeries according to their inherent hemorrhagic risk. Finally, a multidisciplinary agreement on the most appropriate antithrombotic treatment regimen in the perioperative phase was reached for each surgical procedure.

Diabetes mellitus (DM) and small vessel (SV) disease are two major predictors of adverse outcome in patients treated by percutaneous coronary intervention (PCI), even when last generation metallic drug-eluting stents (DES) are used. Bioresorbable scaffold (BRS) technology has been recently developed to overcome the disadvantages of metallic DES due to their permanent struts. Through the resorption process, BRS may provide a vascular restoration that appears very attractive especially when distal or diffusely diseased coronary segments are involved, as in diabetic patients and SV disease. However, robust evidence on the use of BRS in diabetics is lacking, and recent data have raised concerns on the use of BRS in SVs, particularly when reference vessel diameter (RVD) is

Objectives To compare clinical outcomes of patients treated with overlapping versus non-overlapping Absorb BVS. Background: Limited data are available on the clinical impact of stent overlap with the Absorb BVS bioresorbable stent. Methods: We compared outcomes of patients receiving overlapping or non-overlapping Absorb BVS in the multicenter prospective RAI Registry. Results: Out of 1,505 consecutive patients treated with Absorb BVS, 1,384 were eligible for this analysis. Of these, 377 (27%) were in the overlap group, and 1,007 (73%) in the non-overlap group. The most frequent overlap configuration was the marker-to-marker type (48%), followed by marker-over-marker (46%) and marker-inside-marker (6%) types. Patients of the overlap group had higher prevalence of multivessel disease and higher SYNTAX score, and required more frequently the use of intravascular imaging. At a median follow-up of 368 days, no difference was observed between overlap and non-overlap groups in terms of a device-related composite endpoint (cardiac death, TV-MI, ID-TLR) (5.8% vs. 4.1%, P = 0.20) or of a patient-related composite endpoint (any death, any MI, any revascularization) (15.4% vs. 12.5%, P = 0.18). Cardiac death (1.0% vs. 1.3%, P = 0.54), MI (4.5% vs. 3.6%, P = 0.51), TVR (4.5% vs. 3.6%, P = 0.51) and stent thrombosis (1.1 vs. 1.5%, P = 1.00) were also comparable between groups. When assessing outcomes of the overlap population according to overlap configurations used, no difference was observed in terms of the device- or patient-related composite endpoints. Conclusions: Outcomes of patients with or without overlapping BVS were comparable at mid-term follow-up despite higher angiographic complexity of the overlap subset. © 2017 Wiley Periodicals, Inc.

Background Females are continuously growing in interventional communities, but some unmet needs exist on the issue of gender's differences. Purposes To investigate gender's differences on job-habits and private-life in Italian Cath-Labs. Further, the topic of temporary abstention from the interventional activity for any cause (pregnancy, illness, injury) and radioprotection issues were also assessed. Methods A national survey supported by Italian Interventional Cardiology Society (GISE) was submitted by mail to overall 1,230 GISE-members. Questions were formulated in multiple-choice and some required an open answer or a scale definition. Categorical data are presented as numbers and percentages and compared using chi-square test. P-values Results Responders were 326 (26.5%). Sixty-six (20.2%) were young ( Conclusions The number of Young-females' Italian interventional cardiologists is increasing. According to this National survey there are not gender disparities in the working. Conversely several important differences exist in the private-life. There is the need of developing strategies for education, professional advancement in cases of Cath-Lab abstention as well as of sex-specific radio-exposure programs in the field of interventional cardiology. Acknowledgement/Funding None

Background Perioperative management of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients deemed at high thrombotic risk undergoing non-deferrable surgery remains poorly defined. Cangrelor represents a potential treatment option as a “bridge” from discontinuation of oral P2Y12 receptor antagonists to surgical procedures, but data in this setting are still scant. Purpose We sought to describe a real-world experience of a bridging protocol using cangrelor for patients referred to relevant bleeding risk surgery requiring withdrawal of DAPT. Methods We collected data from 7 Italian centers on patients with previous PCI, still on DAPT, undergoing non-deferrable surgery which required discontinuation of one or both antiplatelet agents. A standardized bridging protocol using cangrelor infusion before and eventually after surgery was applied (Figure 1). Results Between December 2017 and January 2019, a total of 18 patients (mean age 70±10 years; male 85%) were enrolled. In the majority (89%) of patients, the index PCI was performed due to acute coronary syndrome (ACS) and 2±1.7 stents per patient were implanted. All patients required non-deferrable, intermediate-high bleeding risk surgery as pulmonary lobectomy, colectomy, endoscopic bladder surgery, paranasal sinus surgery, coronary artery by-pass surgery and valvular repair, hip replacement, endoscopy sphincterotomy. High thrombotic risk categories included PCI time Figure 1. Standardized bridging protocol. Conclusions Peri-operative bridge therapy with cangrelor is a feasible approach for stented patients at high thrombotic risk referred to non-deferrable surgery requiring DAPT discontinuation. Larger studies are warranted to support the safety of this strategy.

Objectives The objective of this study was to investigate mid-term clinical outcomes of patients treated with ‘full-plastic jacket’ (FPJ) everolimus-eluting Absorb bioresorbable vascular scaffold (BRS) implantation. Background FPJ with BRS may represent an interesting option for patient with diffuse coronary artery disease (CAD), but data on the clinical impact of FPJ using the Absorb BRS are scant. Methods FPJ was defined as the implantation of >56 mm of overlapping BRS in at least one vessel. We compared outcomes of patients receiving Absorb FPJ vs. non-FPJ within the multicenter prospective RAI Registry. Results Out of 1505 consecutive patients enrolled in the RAI registry, 1384 were eligible for this analysis. Of these, 143 (10.3%) were treated with BRS FPJ. At a median follow-up of 649 days, no differences were observed between FPJ and non-FPJ groups in terms of the device-oriented composite endpoint (DoCE) (5.6% vs. 4.4%, p = 0.675) or the patient-related composite endpoint (PoCE) (20.9% vs. 15.9%, p = 0.149). Patients receiving FPJ had higher rates of target vessel repeat revascularization (TVR) (11.2% vs. 6.3%, p = 0.042). In the FPJ group, there was no cardiac death and only one (very late) stent thrombosis (ST) (0.7%). Conclusions Mid-term outcomes of a FPJ PCI strategy in the setting of diffuse CAD did not show a significant increase in composite device- and patient-related events, with rates of cardiac death and ST comparable to non-FPJ Absorb BRS implantation. However, these findings are hypothesis generating and requiring further validation.

Background— Invasive physiological assessment of myocardial bridges (MBs) is largely unsettled. Unlike fractional flow reserve (FFR), instantaneous wave–free ratio (iFR) is a diastole-specific index. As such, its value might not be hampered by systolic pressure overshooting and negative systolic pressure gradient caused by the compression of the tunneled coronary artery. Methods and Results— We prospectively enrolled 20 patients with angina and/or positive noninvasive stress test, absence of significant coronary artery stenosis, and angiographic suspicion/evidence of MB in the left anterior descending artery. According to a prespecified protocol, all patients underwent functional intracoronary evaluation with FFR at rest and after dobutamine (up to 20 μg kg −1 min −1 ) and atropine (1 mg) intravenous infusion. iFR at baseline and dobutamine-induced hyperemic wave–free period pressure ratio were also recorded. FFR values ≤0.80 and iFR values ≤0.89 were considered indicative of hemodynamic significance of MB. At baseline, no MB was hemodynamically significant according to FFR, whereas iFR was below the cutoff value in all but 7 patients. During inotropic challenge, median FFR did not change significantly (0.87–0.86, P =0.59). Conclusions— Physiological evaluation of MBs with iFR seems to be more consistent with patients’ symptoms and noninvasive test results compared with FFR.

Background The fully retrievable and repositionable Lotus Valve System uses a unique mechanical expansion mechanism. Balloon aortic valvuloplasty (BAV) is recommended before valve deployment. There are no studies focusing on feasibility and efficacy of Lotus Valve implantation without previous BAV. Methods and results Thirty consecutive patients (63.3% female; mean age, 80±6.2years) underwent transcatheter aortic valve replacement (TAVR) with the Lotus Valve without preparatory BAV. Mean baseline aortic valve area was 0.41±0.14cm 2 /m 2 ; mean transvalvular gradient was 50.2±16.2mmHg. All patients were successfully implanted, with 96.6% device success (VARC-2 definition) and 0% intra-procedural mortality. Partial and full valve repositioning were performed in 11 (36.7%) and 2 (6.7%) cases, respectively. Mean 30-day transprosthetic gradient was 11.3±3.6mmHg, with an effective aortic orifice area of 1.0±0.2cm 2 /m 2 , and more than mild paravalvular leakage (PVL) in only one patient. At 30days, cardiac mortality was 3.3%, and 96.3% of subjects were NYHA Class I or II. The rate of life-threatening bleeding was 10%; one patient experienced disabling stroke. Ten patients underwent new pacemaker implantation (38%). Conclusions TAVR with the mechanically expandable Lotus Valve seems feasible without performing preparatory BAV. Valve hemodynamics at 30-days were favorable, and clinical outcomes were similar to studies employing routine preparatory BAV.

Conflicting data have been reported related to the impact of atrial fibrillation (AF) on the outcomes after transcatheter aortic valve implantation (TAVI). We aimed to assess the prognosis of TAVI-treated patients according to the presence of pre-existing or new-onset AF.Studies published between April 2002 and November 2016 and reporting outcomes of pre-existing AF, new-onset AF, or sinus rhythm in patients undergoing TAVI were identified with an electronic search. Pairwise and network meta-analysis were performed. Outcomes of interest were short- and long-term mortality, stroke, and major bleeding.Eleven studies (11,033 individuals) were eligible. Compared to sinus rhythm, short-term and long-term mortality were significantly higher in new-onset AF (short-term OR 2.9, P=.002; long-term OR 2.3, P.0001) and pre-existing AF groups (short-term OR 2.7, P=.004; long-term OR 2.8, P.0001). Compared to sinus rhythm, new-onset AF increased the risk of stroke at early (OR 2.1, P.0001) and late follow-up (OR 1.92, P.0001), and the risk of early bleedings (OR 1.65, P=.002), while pre-existing AF increased the risk of late stroke (OR 1.3, P=0.03), but not the risk of bleeding. Compared to pre-existing AF, new-onset AF correlated with higher risk of early stroke (OR 1.7, P=.002) and major bleedings (OR 1.7, P=.002).AF is associated with impaired outcomes after TAVI, including mortality, stroke and (limited to new-onset AF) major bleedings. Compared to pre-existing AF, new-onset AF correlates with higher risk of early stroke and major bleedings. Improved management of AF in the TAVI setting, including tailored antithrombotic treatment strategies, remains a relevant need.

Perioperative management of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients at high thrombotic risk undergoing non-deferrable surgery remains poorly defined. Cangrelor represents a potential bridging treatment option. However, there is limited data in this

Women have been reported to have better survival than men undergoing transcatheter aortic valve replacement (TAVR). However, scant data on the sex-based survival benefit of TAVR over surgical aortic valve replacement (SAVR) are available. We sought to explore the time course of survival advantage of

Diabetes mellitus (DM) is associated with increased risk of subsequent events after PCI. To evaluate the impact of Absorb bioresorbable vascular scaffold (BVS) in this setting, we aimed to compare the 1-year outcomes of Absorb BVS versus 2nd generation drug eluting stents (DES) by pooling diabetic