Publications by authors named "Alaide Chieffo"

454 Publications

Impact of membranous septum length on pacemaker need with different transcatheter aortic valve replacement systems: The INTERSECT registry.

J Cardiovasc Comput Tomogr 2022 Jul 13. Epub 2022 Jul 13.

Department of Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands. Electronic address: https://twitter.com/drnvanmieghem.

Background: New permanent pacemaker implantation (new-PPI) remains a compelling issue after Transcatheter Aortic Valve Replacement (TAVR). Previous studies reported the relationship between a short MS length and the new-PPI post-TAVR with a self-expanding THV. However, this relationship has not been investigated in different currently available THV. Therefore, the aim of this study was to investigate the association between membranous septum (MS)-length and new-PPI after TAVR with different Transcatheter Heart Valve (THV)-platforms.

Methods: We included patients with a successful TAVR-procedure and an analyzable pre-procedural multi-slice computed tomography. MS-length was measured using a standardized methodology. The primary endpoint was the need for new-PPI within 30 days after TAVR.

Results: In total, 1811 patients were enrolled (median age 81.9 years [IQR 77.2-85.4], 54% male). PPI was required in 275 patients (15.2%) and included respectively 14.2%, 20.7% and 6.3% for Sapien3, Evolut and ACURATE-THV(p ​< ​0.01). Median MS-length was significantly shorter in patients with a new-PPI (3.7 ​mm [IQR 2.2-5.1] vs. 4.1 ​mm [IQR 2.8-6.0], p ​= ​<0.01). Shorter MS-length was a predictor for PPI in patients receiving a Sapien3 (OR 0.87 [95% CI 0.79-0.96], p ​= ​<0.01) and an Evolut-THV (OR 0.91 [95% CI 0.84-0.98], p ​= ​0.03), but not for an ACURATE-THV (OR 0.99 [95% CI 0.79-1.21], p ​= ​0.91). By multivariable analysis, first-degree atrioventricular-block (OR 2.01 [95% CI 1.35-3.00], p = <0.01), right bundle branch block (OR 8.33 [95% CI 5.21-13.33], p = <0.01), short MS-length (OR 0.89 [95% CI 0.83-0.97], p ​< ​0.01), annulus area (OR 1.003 [95% CI 1.001-1.005], p ​= ​0.04), NCC implantation depth (OR 1.13 [95% CI 1.07-1.19] and use of Evolut-THV(OR 1.54 [95% CI 1.03-2.27], p ​= ​0.04) were associated with new-PPI.

Conclusion: MS length was an independent predictor for PPI across different THV platforms, except for the ACURATE-THV. Based on our study observations within the total cohort, we identified 3 risk groups by MS length: MS length ≤3 ​mm defined a high-risk group for PPI (>20%), MS length 3-7 ​mm intermediate risk for PPI (10-20%) and MS length > 7 ​mm defined a low risk for PPI (<10%). Anatomy-tailored-THV-selection may mitigate the need for new-PPI in patients undergoing TAVR.
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http://dx.doi.org/10.1016/j.jcct.2022.07.003DOI Listing
July 2022

[Percutaneous treatment of acute pulmonary embolism: state of the art].

G Ital Cardiol (Rome) 2022 Jul;23(7):13-21

Emodinamica e Cardiologia Interventistica, IRCCS Ospedale San Raffaele, Milano.

Acute pulmonary embolism (PE) is a common disease associated with high mortality rates that vary widely according to patient clinical presentation and hemodynamic status. According to international guidelines, systemic thrombolysis (ST) is the mainstem treatment in patients with high risk PE and intermediate-high risk PE evolving towards hemodynamic decompensation, showing lower mortality compared with anticoagulant therapy alone despite a high rate of bleeding events. Considering that a large proportion of patients presents contraindication to ST, catheter-directed therapies (CDTs) could tackle some unsolved issues, targeting the treatment to the pulmonary arteries, avoiding the dreaded complications of ST.The aim of this review is to describe the current indication for CDTs in terms of patient selection and timing of treatment, to describe contemporary available medical devices and techniques, discussing current knowledge of safety and efficacy and the importance of multidisciplinary team in PE management.
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http://dx.doi.org/10.1714/3838.38223DOI Listing
July 2022

The impact of chronic kidney disease severity on clinical outcomes after current generation drug-eluting stent implantation for left main distal bifurcation lesions: the Milan and New-Tokyo registry.

Scand Cardiovasc J 2022 12;56(1):236-242

Interventional Cardiology Unit, EMO-GVM, Centro Cuore Columbus, Milan, and Villa Maria Cecilia Hospital GVM, Lugo, Italy.

. The impact of chronic kidney disease (CKD) on clinical outcomes after percutaneous coronary intervention (PCI) for unprotected left main distal bifurcation lesions (ULMD) is not fully understood in current generation drug eluting stent (cDES) era. We assessed clinical outcomes after PCI using cDES for ULMD according to CKD severity based on estimated glomerular filtration rate (eGFR). . We identified 720 consecutive patients who underwent PCI using cDES for ULMD at three high volume centers between January 2005 and December 2015. We divided those patients to the following five groups according to eGFR. Each group was defined as follows: no CKD (60 mL/min/1.73 m ≤ eGFR), mild CKD (45 ≤ eGFR < 60 mL/min/1.73 m), moderate CKD (30 ≤ eGFR < 45 mL/min/1.73 m), severe CKD (15 ≤ eGFR < 30 mL/min/1.73 m) and hemodialysis (HD). The primary endpoint was target lesion failure (TLF) at 3 years. TLF was defined as a composite of cardiac death, target lesion revascularization (TLR) and myocardial infarction (MI). . TLF occurred more frequently in severe CKD and HD group compared with other three groups. . The patients who have severe CKD or are on HD, were extremely associated with worse clinical outcomes after PCI for ULMD even with cDES.
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http://dx.doi.org/10.1080/14017431.2022.2084561DOI Listing
December 2022

STEMIs and a Closer Look at MINOCA During the COVID-19 Pandemic.

J Soc Cardiovasc Angiogr Interv 2022 Jul-Aug;1(4):100372. Epub 2022 May 19.

Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.

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http://dx.doi.org/10.1016/j.jscai.2022.100372DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9117730PMC
May 2022

Emergency department cardiovascular disease encounters and associated mortality in patients with cancer: A study of 20.6 million records from the USA.

Int J Cardiol 2022 Sep 22;363:210-217. Epub 2022 Jun 22.

Keele Cardiovascular Research Group, Centre for Prognosis Research, Keele University, UK; Department of Cardiology, Thomas Jefferson University Philadelphia, PA, USA; Institute of Population Health, University of Manchester, UK. Electronic address:

Background: there is limited data on Emergency department (ED) cardiovascular disease (CVD) presentations and outcomes amongst cancer patients.

Objectives: The present study aimed to describe the clinical characteristics, prevalence, and clinical outcomes of the most common cardiovascular ED admissions in patients with cancer.

Methods: All ED encounters with a primary CVD diagnosis from the US Nationwide Emergency Department Sample between January 2016 to December 2018 were stratified by cancer type as well as metastatic status. Multivariable logistic regression was performed to determine the adjusted odds ratios of in-hospital mortality in different groups.

Results: From a total of 20,737,247 ED encounters with a primary CVD diagnosis, cancer was present in 3.4%. In patients with cancer the most common CVDs were DVT/PE (20%), hypertensive heart or kidney disease (14.7%), and AF/flutter (11.2%). The distribution of CVDs varied by cancer type, with AF/flutter most common in patients with lung cancer, AMI most common in patients with prostate cancer, heart failure most common in those with haematological malignancies, and patients with colorectal cancer having the greatest frequency of DVT/PE. Cancer status was independently associated with significantly higher risk of mortality in almost all CVD categories, consistent across all the cancer types, amongst which lung cancer patients had the highest risk of mortality across all CVD categories, except intracranial haemorrhage and hypertensive crisis.

Conclusions: Cardiovascular presentations to the ED varied by cancer subtype. Across all cancer subtypes, patients presenting with cardiovascular presentations carried a significantly increased risk of mortality compared to patients with no cancer.
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http://dx.doi.org/10.1016/j.ijcard.2022.06.053DOI Listing
September 2022

Transcatheter aortic bioprosthesis durability: A single center experience.

Cardiovasc Revasc Med 2022 May 19. Epub 2022 May 19.

Interventional Cardiology Unit, IRCCS Ospedale San Raffaele, Milan, Italy. Electronic address:

Background: Transcatheter aortic valve implant (TAVI) is gaining momentum in the treatment of severe, symptomatic aortic valve stenosis, and its indication is expanding to lower surgical risk individuals, who are generally younger and have a long life expectancy. Therefore, transcatheter bioprostheses durability appears of critical importance. Aim of the present study is to evaluate mid-term outcomes of TAVI in a high-volume single center cohort.

Methods: We analyzed all consecutive patients (n = 408) who underwent transfemoral TAVI at a single, high-volume center, between 2007 and 2014. Study objectives were all-cause death and bioprosthetic valve failure (BVF) at long term follow-up. Structural valve deterioration (SVD), BVF and valve-related death were defined according to current international standards. Follow-up was performed by in person visit and transthoracic echocardiography, which was obtained only in a minority of patients, or phone call as per patient preference.

Results: At a median follow-up of 1821 days, overall mortality was 64.5%, with cardiovascular disease accounting for roughly half of total deaths. Valve-related deaths occurred in 10 patients. Seventeen patients were diagnosed with BVF, and 15 required repeat intervention. Moderate and severe SVD were observed in 10 and 7 patients, respectively. In the subgroup of patients with echocardiographic mid-term follow-up (n = 76), no significant increase of transprosthetic gradients nor increase of significant regurgitation was detected.

Conclusion: In the present unselected, all-comers cohort, TAVI bioprostheses appeared to have excellent durability at long-term follow-up.
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http://dx.doi.org/10.1016/j.carrev.2022.05.011DOI Listing
May 2022

Antithrombotic strategy variability in atrial fibrillation and obstructive coronary disease revascularised with percutaneous coronary intervention: primary results from the AVIATOR 2 international registry.

EuroIntervention 2022 Jun 3. Epub 2022 Jun 3.

Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Background: Managing percutaneous coronary intervention (PCI) patients with atrial fibrillation (AF) presents challenges given that there are several potential antithrombotic therapy (ATT) strategies.

Aims: We examined ATT patterns, agreement between subjective physician ratings and validated risk scores, physician-patient perceptions influencing ATT and 1-year outcomes.

Methods: The AVIATOR 2 prospective registry enrolled 514 non-valvular AF-PCI patients from 11 sites. Treating physicians selected ATT and completed smartphone surveys rating stroke and bleeding risks, compared against CHADS-VASc and HAS-BLED scores. Patients completed surveys regarding treatment understanding. Primary outcomes were 1-year major adverse cardiac or cerebrovascular events (MACCE: composite of death, myocardial infarction, definite/probable stent thrombosis, stroke, target lesion revascularisation) and actionable bleeding (Bleeding Academic Research Consortium 2, 3 or 5).

Results: The mean patient age was 73.2±9.0 years, including 25.8% females. Triple therapy (TT: 1 anticoagulant and 2 antiplatelet agents) was prescribed in 66.5%, dual antiplatelet therapy (DAPT) in 20.7% and dual therapy (1 anticoagulant+1 antiplatelet agent) in 12.8% of patients. Physician ratings and validated risk scores showed poor agreement (stroke: kappa=0.03; bleeding: kappa=0.07). Physicians rated bleeding-related safety (93.8%) as the main factor affecting ATT choice. Patients worried about stroke over bleeding (50.6% vs 14.8%). No group differences by ATT strategy were observed in 1-year MACCE (TT 14.1% vs dual therapy 12.7% vs DAPT 18.5%; p=0.25), or actionable bleeding (14.7% vs 7.9% vs 15.1%, respectively; p=0.89).

Conclusions: The AVIATOR 2 study is the first digital health study examining physician-patient perspectives on ATT choices after AF-PCI. TT was the most common strategy without differences in 1-year outcomes in ATT strategy. Physicians rated safety first when prescribing ATT; patients feared stroke over bleeding.

Clinicaltrials: gov: NCT02362659.
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http://dx.doi.org/10.4244/EIJ-D-21-01044DOI Listing
June 2022

Temporal patterns, characteristics, and predictors of clinical outcomes in patients undergoing percutaneous coronary intervention for stent thrombosis.

EuroIntervention 2022 May 23. Epub 2022 May 23.

Keele Cardiovascular Research Group, Centre for Prognosis Research, Keele University, Keele, United Kingdom.

Background: There are limited data on the outcomes of percutaneous coronary intervention (PCI) following stent thrombosis (ST) and differences exist based on timing.

Aims: Our aim was to study the rates of PCI procedures for an ST indication among all patients admitted for PCI at a national level and to compare their characteristics and procedural outcomes based on ST timing.

Methods: All PCI procedures in England and Wales (2014-2020) were retrospectively analysed and stratified by the presence of ST into four groups: non-ST, early ST (0-30 days), late ST (>30-360 days), very late ST (>360 days). Multivariable logistic regression models were performed to assess the odds ratios (OR) of in-hospital MACCE (major adverse cardiovascular and cerebrovascular events, a composite of mortality, acute stroke and reinfarction) and mortality.

Results: Overall, 7,923 (1.4%) procedures were for ST indication, most commonly for early ST (n=4,171; 52.6%), followed by very late ST (n=2,801; 35.4%) and late ST (n=951; 12.0%). The rate of PCI for ST declined between 2014 and 2020 (1.7 to 1.4%; p<0.001). Early ST was the only subgroup associated with increased odds of MACCE (OR 1.22, 95% CI: 1.05-1.41), all-cause mortality (OR 1.21, 95% CI: 1.07-1.36) and reinfarction (OR 2.48, 95% CI: 1.48-4.14), compared with non-ST indication. The odds of mortality were significantly reduced in ST patients with the use of intravascular imaging (OR 0.66, 95% CI: 0.48-0.92) and newer P2Y inhibitors (ticagrelor: OR 0.69, 95% CI: 0.49-0.95; prasugrel: OR 0.54, 95% CI: 0.30-0.96).

Conclusions: PCI for ST has declined in frequency over a 7-year period, with most procedures performed for early ST. Among the different times of ST onset, only early ST is associated with worse clinical outcomes after PCI. Routine use of intravascular imaging and newer P2Y inhibitors could further improve outcomes in this high-risk procedural group.
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http://dx.doi.org/10.4244/EIJ-D-22-00049DOI Listing
May 2022

Definitions and Standardized Endpoints for Treatment of Coronary Bifurcations.

J Am Coll Cardiol 2022 Jul 18;80(1):63-88. Epub 2022 May 18.

Department of Cardiology, Saolta Group, Galway University Hospital, Health Service Executive and National University of Ireland Galway, Galway, Ireland.

The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients.
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http://dx.doi.org/10.1016/j.jacc.2022.04.024DOI Listing
July 2022

Definitions and Standardized Endpoints for Treatment of Coronary Bifurcations.

EuroIntervention 2022 May 18. Epub 2022 May 18.

Department of Cardiology, Saolta Group, Galway University Hospital, Health Service Executive and National University of -Ireland Galway, Galway, Ireland.

The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients.
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http://dx.doi.org/10.4244/EIJ-E-22-00018DOI Listing
May 2022

Treatment of coronary bifurcation lesions, part I: implanting the first stent in the provisional pathway. The 16th expert consensus document of the European Bifurcation Club.

EuroIntervention 2022 Aug 5;18(5):e362-e376. Epub 2022 Aug 5.

Department of Cardiology, Clinical Center of Serbia, and Faculty of Medicine, University of Belgrade, Belgrade, Serbia.

Stepwise layered provisional stenting (PS) is the most commonly used strategy to treat coronary bifurcation lesions (CBL). The term 'stepwise layered' emphasises the versatility of this approach that allows the adjustment of the procedure plan according to the CBL complexity, starting with stent implantation in one branch and implantation of a second stent in the other branch only when required. A series of refinements have been implemented over the years to facilitate the achievement of predictable procedural results using this approach. However, despite its simplicity and versatility, operators using this technique require full knowledge of the pitfalls of each procedural step. Part I of this 16 European Bifurcation Club consensus paper provides a detailed step-by-step overview of the pitfalls and technical troubleshooting during the implantation of the first stent using the PS strategy for the treatment of CBL.
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http://dx.doi.org/10.4244/EIJ-D-22-00165DOI Listing
August 2022

Anticoagulation for Percutaneous Ventricular Assist Device-Supported Cardiogenic Shock: JACC Review Topic of the Week.

J Am Coll Cardiol 2022 05;79(19):1949-1962

Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. Electronic address: https://twitter.com/alaide_chief.

Interest in the use of mechanical circulatory support for patients presenting with cardiogenic shock is growing rapidly. The Impella (Abiomed Inc), a microaxial, continuous-flow, short-term, ventricular assist device (VAD), requires meticulous postimplantation management. Because systemic anticoagulation is needed to prevent pump thrombosis, patients are exposed to increased bleeding risk, further aggravated by sepsis, thrombocytopenia, and high shear stress-induced acquired von Willebrand syndrome. The precarious balance between bleeding and thrombosis in percutaneous VAD-supported cardiogenic shock patients is often the main reason that patient outcomes are jeopardized, and there is a lack of data addressing optimal anticoagulation management strategies during percutaneous VAD support. Here, we present a parallel anti-Factor Xa/activated partial thromboplastin time-guided anticoagulation algorithm and discuss pitfalls of heparin monitoring in critically ill patients. This review will guide physicians toward a more standardized (anti)coagulation approach to tackle device-related morbidity and mortality in this critically ill patient group.
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http://dx.doi.org/10.1016/j.jacc.2022.02.052DOI Listing
May 2022

Impact of dual antiplatelet therapy duration on clinical outcome after coronary bifurcation stenting: results from the Euro Bifurcation Club registry.

Panminerva Med 2022 May 13. Epub 2022 May 13.

Department of Cardiology, Clinical Center of Serbia, University of Belgrade, Belgrade, Serbia.

Background: Optimal duration of Dual Antiplatelet Therapy (DAPT) following percutaneous coronary intervention (PCI) of a bifurcation stenosis is still debated. We evaluated the impact of DAPT duration on clinical outcomes in all-comers patients undergoing bifurcation PCI included in the European Bifurcation Club (EBC) registry.

Methods: We enrolled 2284 consecutive patients who completed at least 18 months follow-up. The cumulative occurrence of Major Adverse Cardiac and Cardiovascular Events (MACCE), defined as a composite of overall-death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR) and stroke were evaluated. Bleedings classified as BARC ≥ 3 were evaluated too.

Results: Patients were divided into 3 groups: Short DAPT (<6-months, n=375); Standard DAPT (≥6-months but ≤12-months, n=636); Prolonged DAPT (>12- months, n=1273). At 24 months follow-up MACCE-free survival was significantly lower in Short DAPT patients (Log-Rank: 45.23, p for trend <0.001). MACCE occurred less frequently in the Prolonged DAPT group (148 (11.6%)) as compared with both the Short (83 (22.1%) HR:0.48 (0.37-0.63), p<0.001) and Standard DAPT groups (137 (21.5%) HR:0.51 (0.41-0.65), p<0.001). These differences remain after propensity score adjustment (respectively, HR: 0.27 (0.20-0.36) and HR: 0.44 (0.34-0.57)). Such finding was consistent in patients presenting with both acute and chronic coronary syndromes. BARC ≥ 3 bleedings were 0.3% in the Standard DAPT, 1.6% in Short and 1.9% in Prolonged DAPT groups.

Conclusions: In the "real-world" EBC registry of patients undergoing PCI of coronary artery bifurcation stenosis, a prolonged DAPT duration was associated with a significantly lower risk of MACCE and a potential increased risk of major bleedings.
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http://dx.doi.org/10.23736/S0031-0808.22.04604-3DOI Listing
May 2022

Impact of Small Valve Size on 1-Year Outcomes After Transcatheter Aortic Valve Implantation in Women (from the WIN-TAVI Registry).

Am J Cardiol 2022 06 20;172:73-80. Epub 2022 Apr 20.

Department of Cardiology, AOUP Cisanello, University Hospital, Pisa, Italy.

Although most patients with small aortic annulus are women, there is paucity of data on the prognostic impact of small aortic prosthesis in women who underwent transcatheter aortic valve implantation (TAVI). Therefore, we aimed to evaluate the impact of small valve size on 1-year clinical outcomes after TAVI in women. The Women's INternational Transcatheter Aortic Valve Implantation is an all-women registry evaluating patients with severe aortic stenosis who underwent TAVI. Based on the size of the aortic bioprosthesis implanted, women were stratified into small (≤23 mm) and nonsmall (>23 mm) valve. The primary efficacy endpoint was the Valve Academic Research Consortium-2 composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up. Of 934 women who underwent TAVI, 388 (41.5%) received a small valve. Women with a small valve size had a lower body mass index, lower surgical risk scores, were less likely to suffer from atrial fibrillation, less often required postdilation and had a lower rate of residual aortic regurgitation grade ≥2. The occurrence of the Valve Academic Research Consortium-2 efficacy endpoint was similar between women treated with small and nonsmall valve (16.0% vs 16.3%, p = 0.881; adjusted hazard ratio 1.34, 95% confidence interval 0.90 to 2.00). Likewise, there were no significant differences in the occurrence of other secondary endpoints after multivariable adjustment. In conclusion, women with severe aortic stenosis who underwent TAVI with the implantation of a small valve bioprosthesis had similar 1-year outcomes as those receiving a nonsmall bioprosthesis.
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http://dx.doi.org/10.1016/j.amjcard.2022.02.025DOI Listing
June 2022

Bleeding risk differences after TAVR according to the ARC-HBR criteria: insights from SCOPE 2.

EuroIntervention 2022 Apr 22. Epub 2022 Apr 22.

Division of Cardiology Azienda Ospedaliero Universitaria "Policlinico-Vittorio Emanuele" University of Catania, Catania, Italy.

Background: The Academic Research Consortium - High Bleeding Risk (ARC-HBR) initiative defined conditions associated with percutaneous coronary intervention (PCI)-related bleeding.

Aims: We sought to further explore these HBR conditions in the setting of transcatheter aortic valve replacement (TAVR).

Methods: Patients from the SCOPE 2 trial were stratified by their bleeding risk status based on the ARC-HBR definitions. Baseline and procedural characteristics, as well as key clinical outcomes including Bleeding Academic Research Consortium (BARC) 3-5 bleeding, were compared in ARC-HBR positive (HBR+) and ARC-HBR negative (HBR-) patients.

Results: Of 787 patients randomised in SCOPE 2 and included in this study, 633 were HBR+ (80.4%). Compared with HBR- patients, those HBR+ were older and more frequently presented with diabetes, a history of coronary artery disease, atrial fibrillation, prior cerebrovascular accident, and a Society of Thoracic Surgeons predicted risk of 30-day mortality (STS-PROM) (4.9±2.9% vs 3.3%±2.1%; p<0.0001). In addition, HBR+ patients were more frequently on oral anticoagulation therapy. At 1 year, HBR+ patients had higher rates of all-cause death (12.4% vs 4.3%, respectively, risk difference 8.09%; 95% confidence interval [CI]: 3.76-12.41; p=0.0002); the rates of BARC 3-5 type bleeding were relatively high but not statistically different compared with HBR- patients (7.7% vs 6.1%, risk difference 1.67%; 95% CI: -2.72-6.06; p=0.46). Subgroup analyses for bleeding events showed no significant interaction in terms of STS-PROM score, age, or medications.

Conclusions: The ARC-HBR criteria failed to isolate a subgroup of patients at higher bleeding risk in TAVR patients from a randomised trial. These findings have potential implications, especially for the selection of post-TAVR antithrombotic regimens based on individual bleeding-risk profiles. Specific HBR criteria should be defined for TAVR patients.
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http://dx.doi.org/10.4244/EIJ-D-21-01048DOI Listing
April 2022

Duration and kind of dual antiplatelet therapy for acute coronary syndrome patients: a network meta-analysis.

Minerva Cardiol Angiol 2022 Mar 25. Epub 2022 Mar 25.

Division of Cardiology, Department of Medical Sciences, Città della Salute e della Scienza Hospital, Turin, Italy.

Background: For acute coronary syndrome (ACS) patients treated with percutaneous coronary intervention (PCI), the choice of the duration and kind of dual antiplatelet therapy (DAPT) offering the most accurate balance between ischemic and bleeding risk remains unknown.

Methods: A network meta-analysis was performed including all Randomized Controlled Trials (RCTs) comparing different DAPT regimens and duration in ACS patients undergoing PCI. Trial-defined MACE and major bleedings were the primary endpoints. Stroke, stent thrombosis (ST), all-cause and cardiovascular death, myocardial infarction (MI) represented secondary endpoints.

Results: 13 RCTs encompassing 46145 patients were included. Mean age was 62 (61-64) years old, 42% being admitted with STEMI, 33% with NSTEMI and 25% with UA. The competitive arms were: clopidogrel and aspirin for 12 months (6 arms/18183 patients), clopidogrel and aspirin for 6 months (4/3329), clopidogrel and aspirin > 12 months (3/2238), ticagrelor and aspirin for 12 months (6/12942) and prasugrel and aspirin for 12 months (3/9453). Trial-defined MACE and major bleedings, stroke and death were similar among the different arms. DAPT with prasugrel and aspirin for 12 months reduced MI compared to aspirin and clopidogrel for 12 months (OR 0.71, 95%CI 0.54.0.94), and reduced the risk of ST compared to ticagrelor (OR 0.66, 95%CI 0.49-0.90). Both prasugrel and ticagrelor reduced ST as compared to clopidogrel and aspirin for 12 months.

Conclusions: Different DAPT strategies yield similar risk of MACE, major bleeding, death and stroke in ACS patients. Prasugrel and aspirin for 12 months proved to be the most effective strategy regarding ST and MI.
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http://dx.doi.org/10.23736/S2724-5683.22.06038-0DOI Listing
March 2022

International consensus statement on challenges for women in cardiovascular practice and research in the COVID-19 era.

Minerva Cardiol Angiol 2022 02 25. Epub 2022 Feb 25.

Cardiology Section, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA USA -

The challenges to academic and professional development and career advancement of women in cardiology (WIC), imposed by the pandemic, not only impinge the female cardiologists' "leaky pipeline" but also make the "leakiness" more obvious. This consensus document aims to highlight the pandemic challenges WIC face, raise awareness of the gender equity gap, and propose mitigating actionable solutions derived from the data and experiences of an international group of female cardiovascular clinicians and researchers. This changing landscape has led to the need for highly specialized cardiologists who may have additional training in critical care, imaging, advanced heart failure, or interventional cardiology. Although women account for most medical school graduates, the number of WIC, particularly in mentioned sub-specialties, remains low. Moreover, women have been more affected by systemic issues within these challenging work environments, limiting their professional progression, career advancement, and economic potential. Therefore, it is imperative that tangible action points be noted and undertaken to ensure the representation of women in leadership, advocacy, and decision-making, and increase diversity in academia. Strategies to mitigate the negative impacts of the pandemic need to be taken during this COVID-19 pandemic to ensure WIC have a place in the field of Cardiology.
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http://dx.doi.org/10.23736/S2724-5683.22.05935-XDOI Listing
February 2022

Sex Differences in Outcomes After Percutaneous Coronary Intervention or Coronary Artery Bypass Graft for Left Main Disease: From the DELTA Registries.

J Am Heart Assoc 2022 03 22;11(5):e022320. Epub 2022 Feb 22.

Interventional Cardiology Unit San Raffaele Scientific Institute Milan Italy.

Background Controversy exists over whether sex has significant interaction with revascularization strategy for unprotected left main coronary artery disease. Higher mortality has been reported among women treated with percutaneous coronary intervention compared with coronary artery bypass grafting. Methods and Results The DELTA (Drug-Eluting Stents for Left Main Coronary Artery Disease) and DELTA-2 registries are international, multicentric registries evaluating the outcomes of subjects undergoing coronary revascularization for unprotected left main coronary artery disease. The primary outcome was a composite of death, myocardial infarction, or cerebrovascular accidents. The population consisted of 6253 patients, including 1689 (27%) women. Women were older and more likely to have diabetes and chronic kidney disease than men (<0.05). At a median follow-up of 29 months (interquartile range 12-49), a significant interaction between sex and revascularization strategy was observed for the primary end point (p=0.012) and all-cause death (p=0.037). Among women, compared with percutaneous coronary intervention, coronary artery bypass grafting was associated with lower risk of the primary end point (event rate 9.5% versus 15.3%; adjusted hazard ratio [AHR], 0.53; 95% CI, 0.35-0.79, <0.001) and all-cause death (event rate 5.6% versus 11.7% AHR, 0.50; 95% CI, 0.30-0.82) and no significant differences were observed in men. Conclusions In women undergoing coronary revascularization for unprotected left main coronary artery disease, coronary artery bypass grafting was associated with lower risk of death, myocardial infarction, or cerebrovascular accidents whereas no significant differences between coronary artery bypass grafting and percutaneous coronary intervention were observed in men. Further dedicated studies are needed to determine the optimal revascularization strategy in women with unprotected left main coronary artery disease.
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http://dx.doi.org/10.1161/JAHA.121.022320DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9075069PMC
March 2022

Impact of Left Main Calcium With Chronic Kidney Disease on Outcomes After Percutaneous Coronary Intervention for Left Main Narrowings (from the Milan and New-Tokyo Registry).

Am J Cardiol 2022 04 8;168:31-38. Epub 2022 Feb 8.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Humanitas Clinical and Research Center, Istituto di Ricovero e Cura a Carattere Scientifico, Rozzano, Milan, Italy.

Limited data are available about the association between coronary artery calcification and chronic kidney disease severity on clinical outcomes after percutaneous coronary intervention (PCI). This study aimed to assess the association between coronary artery calcification and chronic kidney disease severity on clinical outcomes after PCI. We identified 1,391 patients treated with drug-eluting stent for unprotected left main distal bifurcation lesions (ULMD), including 604 without calcified lesions (noncalcified left main group) and 787 with calcified ULMD (calcified left main group) in Japan and Italy. We divided the calcified group into the following 2 groups: estimated glomerular filtration rate (eGFR) ≥30 (n = 687) and <30 (n = 100) and compared the clinical outcomes. The primary end point was target lesion failure (TLF) at 3 years. TLF was defined as a composite of cardiac death, target lesion revascularization, and myocardial infarction. TLF occurred more frequently in the calcified group (adjusted hazard ratio 1.36, 95% confidence interval 1.08 to 1.71, p = 0.01), especially in calcified ULMD with eGFR <30 (adjusted hazard ratio relative to the other 2 groups 2.59, 95% confidence interval 1.60 to 4.18, p <0.001). In conclusion, the calcified ULMD treated with PCI was associated with poorer clinical outcomes than noncalcified ULMD, especially in those with eGFR <30.
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http://dx.doi.org/10.1016/j.amjcard.2021.12.013DOI Listing
April 2022

Safety and efficacy of different P2Y12 inhibitors in patients with acute coronary syndromes stratified by the PRAISE risk score: a multi-center study.

Eur Heart J Qual Care Clin Outcomes 2022 Jan 12. Epub 2022 Jan 12.

Division of Cardiology, University of Turin.

Aims: To establish the safety and efficacy of different dual antiplatelet therapy (DAPT) combinations in patients with acute coronary syndrome (ACS) according to their baseline ischemic and bleeding risk estimated with a machine learning (ML)-derived model (PRAISE score).

Methods And Results: Incidences of death, re-acute myocardial infarction (re-AMI) and BARC 3-5 bleeding with aspirin plus different P2Y12 inhibitors (clopidogrel or potent P2Y12 inhibitors: ticagrelor or prasugrel) were appraised among patients of the PRAISE dataset grouped in four sub-cohorts: low-to-moderate ischemic and bleeding risk; low-to-moderate ischemic risk and high bleeding risk; high ischemic risk and low-to-moderate bleeding risk; high ischemic and bleeding risk. Hazard ratios (HRs) for the outcome measures were derived with inverse probability of treatment weighting adjustment. Among patients with low-to-moderate bleeding risk, clopidogrel was associated with higher rates of re-AMI in those at low-to-moderate ischemic risk (HR 1.69, 95% CI 1.16-2.51; p = 0.006) and increased risk of death (HR 3.2, 1.45-4.21; p = 0.003) and re-AMI (HR 2.23, 1.45-3.41; p<0.001) in those at high ischemic risk compared to prasugrel or ticagrelor, without difference in the risk of major bleeding. Among patients with high bleeding risk, clopidogrel showed comparable risk of death, re-AMI and major bleeding vs potent P2Y12 inhibitors, regardless of the baseline ischemic risk.

Conclusions: Among ACS patients with non-high risk of bleeding, the use of potent P2Y12 inhibitors is associated with a lower risk or death and recurrent ischemic events, without bleeding excess. Patients deemed at high bleeding risk may instead be safely addressed to a less intensive DAPT strategy with clopidogrel.
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http://dx.doi.org/10.1093/ehjqcco/qcac002DOI Listing
January 2022

Post-stenting optimisation techniques in bifurcation percutaneous coronary interventions: much remains to be explored.

EuroIntervention 2021 Dec 3;17(11):e869-e871. Epub 2021 Dec 3.

Interventional Cardiology Unit, IRCCS San Raffaele Hospital, Milan, Italy.

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http://dx.doi.org/10.4244/EIJV17I11A146DOI Listing
December 2021

European Society of Cardiology guidance for the diagnosis and management of cardiovascular disease during the COVID-19 pandemic: part 1-epidemiology, pathophysiology, and diagnosis.

Cardiovasc Res 2022 05;118(6):1385-1412

Department of Internal Medicine/Cardiology/Electrophysiology, Heart Center Leipzig, University Hospital Leipzig, Leipzig, Germany.

Aims: Since its emergence in early 2020, the novel severe acute respiratory syndrome coronavirus 2 causing coronavirus disease 2019 (COVID-19) has reached pandemic levels, and there have been repeated outbreaks across the globe. The aim of this two-part series is to provide practical knowledge and guidance to aid clinicians in the diagnosis and management of cardiovascular disease (CVD) in association with COVID-19.

Methods And Results: A narrative literature review of the available evidence has been performed, and the resulting information has been organized into two parts. The first, reported here, focuses on the epidemiology, pathophysiology, and diagnosis of cardiovascular (CV) conditions that may be manifest in patients with COVID-19. The second part, which will follow in a later edition of the journal, addresses the topics of care pathways, treatment, and follow-up of CV conditions in patients with COVID-19.

Conclusion: This comprehensive review is not a formal guideline but rather a document that provides a summary of current knowledge and guidance to practicing clinicians managing patients with CVD and COVID-19. The recommendations are mainly the result of observations and personal experience from healthcare providers. Therefore, the information provided here may be subject to change with increasing knowledge, evidence from prospective studies, and changes in the pandemic. Likewise, the guidance provided in the document should not interfere with recommendations provided by local and national healthcare authorities.
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http://dx.doi.org/10.1093/cvr/cvab342DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8690255PMC
May 2022

Risk-Benefit of 1-Year DAPT After DES Implantation in Patients Stratified by Bleeding and Ischemic Risk.

J Am Coll Cardiol 2021 11;78(20):1968-1986

Cardiovascular Research Foundation, New York, New York, USA; Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address:

Background: Although a 1-year duration of dual antiplatelet therapy (DAPT) is used in many patients after drug-eluting stent (DES) implantation, the evidence supporting this duration is uncertain.

Objectives: The authors investigated the risk-benefit profile of 1-year vs ≤6-month DAPT after DES using 2 novel scores to risk stratify bleeding and ischemic events.

Methods: Ischemic and bleeding risk scores were generated from ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents), a multicenter, international, "all-comers" registry that enrolled 8,665 patients treated with DES. The risk-benefit profile of 1-year vs ≤6-month DAPT was then investigated across risk strata from an individual patient data pooled dataset of 7 randomized trials that enrolled 15,083 patients treated with DES.

Results: In the derivation cohort, the ischemic score and the bleeding score had c-indexes of 0.76 and 0.66, respectively, and both were well calibrated. In the pooled dataset, no significant difference was apparent in any ischemic endpoint between 1-year and ≤6-month DAPT, regardless of the risk strata. In the overall dataset, there was no significant difference in the risk of clinically relevant bleeding between 1-year and ≤6-month DAPT; however, among 2,508 patients at increased risk of bleeding, 1-year compared with ≤6-month DAPT was associated with greater bleeding (HR: 2.80; 95% CI: 1.12-7.13) without a reduced risk of ischemic events in any risk strata, including those with acute coronary syndromes. These results were consistent in a network meta-analysis.

Conclusions: In the present large-scale study, compared with ≤6-month DAPT, a 1-year duration of DAPT was not associated with reduced adverse ischemic events in any risk strata (including acute coronary syndromes) but was associated with greater bleeding in patients at increased risk of bleeding.
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http://dx.doi.org/10.1016/j.jacc.2021.08.070DOI Listing
November 2021

Performance of Thin-Strut Stents in Non-Left Main Bifurcation Coronary Lesions: A RAIN Subanalysis.

J Invasive Cardiol 2021 Nov;33(11):E890-E899

Department of Medical Sciences, Division of Cardiology, AOU Città della Salute e della Scienza, University of Turin, Corso Bramante 88/90, 10126, Turin, Italy.

Objectives: This study assesses the safety and efficacy of thin-strut stents in non-left main (non-LM) bifurcation coronary lesions.

Background: Thinner struts of recent drug-eluting stent (DES) devices are associated with improved outcomes, but data about their performance in challenging scenarios are scant.

Methods: RAIN was a retrospective multicenter registry enrolling patients with coronary bifurcation lesions or left main (LM) disease treated with thin-strut DESs. Target-lesion revascularization (TLR) was the primary endpoint, while major adverse clinical event (MACE) rate, a composite of all-cause death, myocardial infarction (MI), target-vessel revascularization (TVR), TLR, and stent thrombosis (ST), and its single components were the secondary endpoints. Multivariable analysis was performed to identify predictors of TLR. Outcome incidences according to stenting strategy (provisional vs 2-stent technique), use of final kissing balloon (FKB), and intravascular ultrasound/optical coherence tomography optimization were further investigated in prespecified subanalyses.

Results: A total of 1803 patients (59% acute coronary syndrome, 41% stable coronary artery disease) with non-LM bifurcations were enrolled. After a median follow-up of 12 months, TLR incidence was 2.5% (2.2% for provisional stenting and 3.5% for 2-stent technique). MACE rate was 9.4% (all-cause death, 4.1%; MI, 3.2%; TVR, 3.7%; definite ST, 1.1%). After multivariable adjustment, postdilation (hazard ratio [HR], 0.32; 95% confidence interval [CI], 0.15-0.71; P<.01) and provisional stenting (HR, 0.62; 95% CI, 0.55-0.89; P=.03) were associated with lower TLR rates. FKB was associated with a lower incidence of TLR in the 2-stent subgroup (P=.03). Intracoronary imaging had no significant impact on the primary endpoint.

Conclusions: Thin-strut DES options represent an effective choice in bifurcation lesions. Postdilation and provisional stenting are associated with a reduced risk of TLR. FKB should be recommended in 2-stent techniques.
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November 2021

The importance of proximal optimization technique with intravascular imaging guided for stenting unprotected left main distal bifurcation lesions: The Milan and New-Tokyo registry.

Catheter Cardiovasc Interv 2021 11 14;98(6):E814-E822. Epub 2021 Sep 14.

Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy.

Objectives: This study evaluated the 5-years outcomes of intracoronary imaging-guided proximal optimization technique (POT) for percutaneous coronary intervention (PCI) in patients with unprotected left main distal bifurcation lesions (ULMD).

Background: The long-term effects of POT with intracoronary imaging guide in PCI for ULMD have been unclear.

Methods: Between January 2005 and December 2015, we identified 1832 consecutive patients who underwent DES implantation for ULM distal bifurcation lesions. Of them, 780 (56.1%) patients underwent POT with intravascular imaging guidance (optimal expansion group). Residual 611 (43.9%) patients did not undergo either POT or intravascular imaging or both (suboptimal expansion group). Analysis using propensity score adjustment was performed. The primary endpoint was target lesion failure (TLF) defined as a composite of cardiac death, target lesion revascularization (TLR), and myocardial infarction.

Results: TLF rate at 5 years was significantly lower in optimal expansion group than that in suboptimal expansion group [adjusted HR 0.65, 95% CI (0.48-0.87), p = 0.004]. Cardiac mortality was significantly lower in optimal expansion group than that in suboptimal expansion group [adjusted HR 0.46, 95% CI (0.27-0.79), p = 0.004]. The multivariable analysis identified POT with intravascular imaging guide [adjusted HR 0.65, 95% CI (0.48-0.87), p = 0.004] as an independent predictor of TLF.

Conclusions: Intravascular imaging guided POT was strongly associated with the reduced risk of TLF at 5 years after PCI for ULMD, mainly driven by reducing cardiac mortality.
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http://dx.doi.org/10.1002/ccd.29954DOI Listing
November 2021

Device-related complications after Impella mechanical circulatory support implantation: an IMP-IT observational multicentre registry substudy.

Eur Heart J Acute Cardiovasc Care 2021 Dec;10(9):999-1006

Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, 60, Via Olgettina, 20132 Milan, Italy.

Aims: To report the incidence, the predictors and clinical impact of device-related complications (DRCs) in the IMP-IT (IMPella Mechanical Circulatory Support Device in Italy) registry. Impella is percutaneous left ventricular assist devices, which provides mechanical circulatory support both in cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI). The IMP-IT registry is a multicentre registry evaluating the trends in use and clinical outcomes of Impella in Italy.

Methods And Results: A total of 406 patients have been included in this registry: 56.4% in the setting of CS, while 43.6% patients in the setting of HR-PCI. DRCs were defined as a composite endpoint of access-site bleeding, limb ischaemia, vascular complication requiring treatment, haemolysis, aortic injury, and left ventricular perforation. DRC incidence in the overall population was 25.6%, with significantly higher rate in the CS (37.1%) than in the HR-PCI (10.7%) group. The most frequent complication was haemolysis (11.8%), which occurred almost exclusively in CS population. Access-site bleeding was observed in 9.6% of the overall population, with no significant difference between the two groups. Limb ischaemia was observed in 8.3% of the overall population, with significantly higher rate in the CS group. CS and right ventricular dysfunction appear as the strongest independent predictors of DRC. One-year mortality in patients with DRC appears higher than in patients with no DRC. However, DRC was not confirmed as an independent predictor of 1-year mortality at multivariate analysis.

Conclusion: In the IMP-IT registry, the rate of DRC was 25.6%, with CS being the strongest independent predictor. DRC was not found as an independent predictor of 1-year mortality.
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http://dx.doi.org/10.1093/ehjacc/zuab051DOI Listing
December 2021
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