Publications by authors named "Chiara Fraccaro"

102 Publications

Improvement of symptoms and coronary perfusion gradient with mechanical left ventricular unloading in flow-limiting complex spontaneous coronary artery dissection, without revascularization.

Catheter Cardiovasc Interv 2021 Jun 15. Epub 2021 Jun 15.

Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.

Spontaneous coronary artery dissection (SCAD) can lead to acute coronary syndrome and sudden cardiac death, particularly in young women. Observational data show that, in SCAD patients, both percutaneous coronary intervention and coronary artery bypass grafting seem to be hampered by higher technical complexity, lower success rates, and worse outcomes. As spontaneous healing is a common occurrence, expert consensus advices medical management of the acute phase, when feasible. We present the case of a young woman with SCAD of left anterior descending artery causing myocardial infarction with ST-segment elevation. High-anatomical complexity and unstable conditions of the patient made both medical management and immediate revascularization unfeasible options. Therefore, we decided to implant a percutaneous off-loading mechanical support device to improve coronary perfusion pressure by unloading the left ventricle and preserve cardiac function, preventing worse complications of acute myocardial infarction. This strategy was successful in stabilizing the patient, until the definitive revascularization treatment became an option.
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http://dx.doi.org/10.1002/ccd.29836DOI Listing
June 2021

Incidence, predictors and clinical impact of permanent pacemaker insertion in women following transcatheter aortic valve implantation: Insights from a prospective multinational registry.

Catheter Cardiovasc Interv 2021 Jun 12. Epub 2021 Jun 12.

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Objectives: To describe the incidence, predictors, and clinical impact of permanent pacemaker insertion (PPI) following transcatheter aortic valve replacement (TAVR) in women.

Background: Data on pacemaker insertion complicating TAVR in women are scarce.

Methods: The Women's International Transcatheter Aortic Valve implantation (WIN-TAVI) is a prospective registry evaluating the safety and efficacy of TAVR in women. We included patients without preprocedural pacemakers and divided them into two groups: (1) PPI and (2) no-PPI. We identified PPI predictors using logistic regression and studied its clinical impact on the Valve Academic Research Consortium (VARC)-2 efficacy and safety endpoints.

Results: Out of 1019 patients, 922 were included in the analysis. Post-TAVR PPI occurred in 132 (14.3%) patients. Clinical and procedural characteristics were similar in both groups. Pre-existing right bundle branch block (RBBB) was associated with a high risk of post-TAVR PPI (OR 3.62, 95% CI 1.85-7.06, p < 0.001), while implantation of balloon-expandable prosthesis was associated with a lower risk (OR 0.47, 95% CI 0.30-0.74, p < 0.001). Post-TAVR PPI prolonged in-hospital stay by a median of 2 days (11 [9-16] days in PPI vs. 9 [7-14] days in no-PPI, p = 0.005), yet risks of VARC-2 efficacy and safety endpoints at 1 year were similar in both groups ( HR 0.95, 95% CI 0.60-1.52, p = 0.84 and HR 1.22, 95% CI 0.83-1.79, p = 0.31, respectively).

Conclusion: Pacemaker implantation following TAVR is frequent among women and is associated with pre-existing RBBB and valve type. PPI prolongs hospital stay, albeit without any significant impact on 1-year outcomes.
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http://dx.doi.org/10.1002/ccd.29807DOI Listing
June 2021

Incidence, Causes, and Outcomes Associated With Urgent Implantation of a Supplementary Valve During Transcatheter Aortic Valve Replacement.

JAMA Cardiol 2021 May 19. Epub 2021 May 19.

Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.

Importance: Transcatheter aortic valve replacement (TAVR) failure is often managed by an urgent implantation of a supplementary valve during the procedure (2-valve TAVR [2V-TAVR]). Little is known about the factors associated with or sequelae of 2V-TAVR.

Objective: To examine the incidence, causes, and outcomes of 2V-TAVR.

Design, Setting, And Participants: A retrospective cohort study was performed using data from an international registry of 21 298 TAVR procedures performed from January 1, 2014, through February 28, 2019. Among the 21 298 patients undergoing TAVR, 223 patients (1.0%) undergoing 2V-TAVR were identified. Patient-level data were available for all the patients undergoing 2V-TAVR and for 12 052 patients (56.6%) undergoing 1V-TAVR. After excluding patients with missing 30-day follow-up or data inconsistencies, 213 2V-TAVR and 10 010 1V-TAVR patients were studied. The 2V-TAVR patients were compared against control TAVR patients undergoing a 1-valve TAVR (1V-TAVR) using 1:4 17 propensity score matching. Final analysis included 1065 (213:852) patients.

Exposures: Urgent implantation of a supplementary valve during TAVR.

Main Outcomes And Measures: Mortality at 30 days and 1 year.

Results: The 213 patients undergoing 2V-TAVR had similar age (mean [SD], 81.3 [0.5] years) and sex (110 [51.6%] female) as the 10 010 patients undergoing 1V-TAVR (mean [SD] age, 81.2 [0.5] years; 110 [51.6%] female). The 2V-TAVR incidence decreased from 2.9% in 2014 to 1.0% in 2018 and was similar between repositionable and nonrepositionable valves. Bicuspid aortic valve (odds ratio [OR], 2.20; 95% CI, 1.17-4.15; P = .02), aortic regurgitation of moderate or greater severity (OR, 2.02; 95% CI, 1.49-2.73; P < .001), atrial fibrillation (OR, 1.43; 95% CI, 1.07-1.93; P = .02), alternative access (OR, 2.59; 95% CI, 1.72-3.89; P < .001), early-generation valve (OR, 2.32; 95% CI, 1.69-3.19; P < .001), and self-expandable valve (OR, 1.69; 95% CI, 1.17-2.43; P = .004) were associated with higher 2V-TAVR risk. In 165 patients (80%), the supplementary valve was implanted because of residual aortic regurgitation after primary valve malposition (94 [46.4%] too high and 71 [34.2%] too low). In the matched 2V-TAVR vs 1V-TAVR cohorts, the rate of device success was 147 (70.4%) vs 783 (92.2%) (P < .001), the rate of coronary obstruction was 5 (2.3%) vs 3 (0.4%) (P = .10), stroke rate was 9 (4.6%) vs 13 (1.6%) (P = .09), major bleeding rates were 25 (11.8%) vs 46 (5.5%) (P = .03) and annular rupture rate was 7 (3.3%) vs 3 (0.4%) (P = .03). The hazard ratios for mortality were 2.58 (95% CI, 1.04-6.45; P = .04) at 30 days, 1.45 (95% CI, 0.84-2.51; P = .18) at 1 year, and 1.20 (95% CI, 0.77-1.88; P = .42) at 2 years. Nontransfemoral access and certain periprocedural complications were independently associated with higher risk of death 1 year after 2V-TAVR.

Conclusions And Relevance: In this cohort study, valve malposition was the most common indication for 2V-TAVR. Incidence decreased over time and was low overall, although patients with a bicuspid or regurgitant aortic valve, nontransfemoral access, and early-generation or self-expandable valve were at higher risk. These findings suggest that compared with 1V-TAVR, 2V-TAVR is associated with high burden of complications and mortality at 30 days but not at 1 year.
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http://dx.doi.org/10.1001/jamacardio.2021.1145DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8135057PMC
May 2021

Tailwind of transcatheter mitral valve repair pushes forward the treatment of acute mitral regurgitation after myocardial infarction.

Catheter Cardiovasc Interv 2021 May;97(6):1268-1269

Department of Cardiac, Thoracic, Vascular Science and Public Health, University of Padova, Padova, Italy.

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http://dx.doi.org/10.1002/ccd.29728DOI Listing
May 2021

ST-Segment Elevation Myocardial Infarction Following Transcatheter Aortic Valve Replacement.

J Am Coll Cardiol 2021 May;77(17):2187-2199

Hospital Universitario Ramón y Cajal, Madrid, Spain.

Background: Among patients with acute coronary syndrome following transcatheter aortic valve replacement (TAVR), those presenting with ST-segment elevation myocardial infarction (STEMI) are at highest risk.

Objectives: The goal of this study was to determine the clinical characteristics, management, and outcomes of STEMI after TAVR.

Methods: This was a multicenter study including 118 patients presenting with STEMI at a median of 255 days (interquartile range: 9 to 680 days) after TAVR. Procedural features of STEMI after TAVR managed with primary percutaneous coronary intervention (PCI) were compared with all-comer STEMI: 439 non-TAVR patients who had primary PCI within the 2 weeks before and after each post-TAVR STEMI case in 5 participating centers from different countries.

Results: Median door-to-balloon time was higher in TAVR patients (40 min [interquartile range: 25 to 57 min] vs. 30 min [interquartile range: 25 to 35 min]; p = 0.003). Procedural time, fluoroscopy time, dose-area product, and contrast volume were also higher in TAVR patients (p < 0.01 for all). PCI failure occurred more frequently in patients with previous TAVR (16.5% vs. 3.9%; p < 0.001), including 5 patients in whom the culprit lesion was not revascularized owing to coronary ostia cannulation failure. In-hospital and late (median of 7 months [interquartile range: 1 to 21 months]) mortality rates were 25.4% and 42.4%, respectively (20.6% and 38.2% in primary PCI patients), and estimated glomerular filtration rate <60 ml/min (hazard ratio [HR]: 3.02; 95% confidence interval [CI]: 1.42 to 6.43; p = 0.004), Killip class ≥2 (HR: 2.74; 95% CI: 1.37 to 5.49; p = 0.004), and PCI failure (HR: 3.23; 95% CI: 1.42 to 7.31; p = 0.005) determined an increased risk.

Conclusions: STEMI after TAVR was associated with very high in-hospital and mid-term mortality. Longer door-to-balloon times and a higher PCI failure rate were observed in TAVR patients, partially due to coronary access issues specific to the TAVR population, and this was associated with poorer outcomes.
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http://dx.doi.org/10.1016/j.jacc.2021.03.014DOI Listing
May 2021

[Presentation].

G Ital Cardiol (Rome) 2021 03;22(3 Suppl 1):3S-4S

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http://dx.doi.org/10.1714/3578.35627DOI Listing
March 2021

Twilight-specific light cues.

Catheter Cardiovasc Interv 2021 01;97(1):72-73

Department of Cardiac, Thoracic, Vascular Science and Public Health, University of Padova, Italy.

The TWILIGHT-SYNERGY subgroup analysis demonstrated comparable safety and efficacy of the bioabsorbable polymer (BP) everolimus-eluting stent versus durable polymer DES in high-risk patients undergoing PCI, as well as advantage of 3 months DAPT followed by ticagrelor monotherapy, as compared with long term DAPT, in term of ischemic and hemorrhagic profile irrespective of DES type. This study confirms and extends previous evidences about safety profile of BP-DES and short term DAPT also in high risk patients. Future studies should focus on further technological improvements and on particular clinical setting where these devices could prove potential superiority.
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http://dx.doi.org/10.1002/ccd.29443DOI Listing
January 2021

Transcatheter Replacement of Transcatheter Versus Surgically Implanted Aortic Valve Bioprostheses.

J Am Coll Cardiol 2021 01;77(1):1-14

Herzzentrum Duisburg, Duisburg, Germany.

Background: Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions.

Objectives: The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs).

Methods: Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year.

Results: For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm vs. 1.37 ± 0.5 cm; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003).

Conclusions: In propensity score-matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality.
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http://dx.doi.org/10.1016/j.jacc.2020.10.053DOI Listing
January 2021

The anatomy is the plastic image of function: the role of the ventricle-aortic angle in TAVR.

Catheter Cardiovasc Interv 2020 12;96(7):1520-1521

Department of Cardiac, Thoracic, Vascular Science and Public Health, University of Padova, Padova, Italy.

The horizontal aorta of 51° or more, dilated annulus and severe asymmetric calcifications result the three anatomical key features in predicting worse outcome after transfemoral TAVR with the new iterations of self-expandable devices. These findings further validate the ESC guidelines on the importance of anatomical factors in favoring TAVR or surgical aortic valve replacement. Future trials on head to head comparison between valves and on the role of ancillary devices are important to refine final decision making of the heart team on the type of aortic valve replacement and type of valve.
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http://dx.doi.org/10.1002/ccd.29416DOI Listing
December 2020

Anatomical Predictors of Pacemaker Dependency After Transcatheter Aortic Valve Replacement.

Circ Arrhythm Electrophysiol 2021 01 11;14(1):e009028. Epub 2020 Dec 11.

Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Italy.

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]; =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]; =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]; =0.11 and odds ratio, 1.11 [95% CI, 0.99-1.24]; =0.08). At a median follow-up of 28.1 (11.7-48.6) months, pacemaker-dependent patients did not show a worse survival (=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.
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http://dx.doi.org/10.1161/CIRCEP.120.009028DOI Listing
January 2021

Appropriate use criteria for coronary angiography: a single centre experience.

Int J Cardiol Heart Vasc 2020 Dec 30;31:100677. Epub 2020 Nov 30.

Cardiology Department, Mazzoni Hospital, via degli Iris 1, 63100 Ascoli Piceno, Italy.

Background: Increasing attention is being given to the rational use of invasive procedures. In this study, we aimed to evaluate, among patients referred for coronary angiography, the appropriateness of cardiac catheterization according to the Appropriate Use Criteria (AUC) for diagnostic catheterization and to examine the relationship between the appropriateness and the presence of obstructive coronary artery disease (CAD) and revascularization.

Methods: From November 2017 to December 2018, 1188 consecutive patients referred to undergo a diagnostic catheterization were included. They were categorized as having appropriate, uncertain or inappropriate indication, using a database (Melograno System). We restricted our analysis to 9 appropriate indications including acute coronary syndromes, suspected CAD, valvular heart disease, arrhythmias and cardiomyopathy. We restricted the analysis to the subgroup of patients with suspected or known CAD and, among them, we evaluate the rate of CAD and the need for revascularization.

Results: The indications were appropriate in 1017 patients (85.6%), of uncertain appropriateness in 134 (11.3%), and inappropriate in 37 (3.1%). Restricting the analysis to the CAD subgroup, the indications were appropriate in 848 patients (83.3%), of uncertain appropriateness in 133 (13.1%) and inappropriate in 37 (3.6%). The proportion of patients with critical CAD were 75.9%, 44.3% and 29.7% in the appropriate, uncertain and inappropriate categories respectively (p < 0.001). The revascularization rate was 63.1%, 32.2% and 21.6% in the appropriate, uncertain and inappropriate categories respectively (p < 0.001).

Conclusions: Application of AUC is feasible in a community setting. Melograno system is useful to improve patient care.
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http://dx.doi.org/10.1016/j.ijcha.2020.100677DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7711284PMC
December 2020

[Prosthesis embolization during transcatheter aortic valve implantation].

G Ital Cardiol (Rome) 2020 11;21(11 Suppl 1):35S-44S

Emodinamica e Cardiologia Interventistica, Dipartimento di Scienze Cardio-Toraco-Vascolari e Sanità Pubblica, AOU Padova, Padova.

Transcatheter aortic valve implantation (TAVI) has been a revolution in the treatment of severe aortic stenosis evolving to a high procedural success rate and low rate of complications. Embolization of the percutaneous device is a rare but potentially life-threatening complication. The spectrum of clinical manifestations ranges between incidental finding on cardiac imaging to cardiogenic shock or cardiac arrest. Data about predictors and management of transcatheter heart valve embolization are scarce and mostly anecdotical. Management strategies are related to the type, the size, the location of the embolized device, the timing of diagnosis, and the clinical presentation of the patient. According to recent data from TRAVEL registry, device embolization and migration occur in approximately 1% of the patients and is responsible for increased morbidity and mortality. However, in a considerable proportion of cases it could have been prevented, hence structural interventionalists should plan the procedures carefully and know thoroughly the risk factors for device embolization. Increased awareness of predisposing factors, preventive measures, and appropriate bail-out options and techniques are strongly advisable. This paper is a review of the incidence, and outcomes of percutaneous prosthesis embolization during TAVI. It also suggests an integrated algorithmic approach for the management of device embolization incorporating both percutaneous and surgical techniques.
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http://dx.doi.org/10.1714/3487.34671DOI Listing
November 2020

Using Wearable Devices to Monitor Physical Activity in Patients Undergoing Aortic Valve Replacement: Protocol for a Prospective Observational Study.

JMIR Res Protoc 2020 Nov 12;9(11):e20072. Epub 2020 Nov 12.

Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.

Background: In last few decades, several tools have been developed to measure physical function objectively; however, their use has not been well established in clinical practice.

Objective: This study aims to describe the preoperative physical function and to assess and compare 6-month postoperative changes in the physical function of patients undergoing treatment for aortic stenosis with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). The study also aims to evaluate the feasibility of wearable devices in assessing physical function in such patients.

Methods: This is a prospective observational study. The enrollment will be conducted 1 month before patients' SAVR/TAVR. Patients will be provided with the wearable device at baseline (activity tracker device, Garmin vívoactive 3). They will be trained in the use of the device, and they will be requested to wear it on the wrist of their preferred hand until 12 months after SAVR/TAVR. After baseline assessment, they will undergo 4 follow-up assessments at 1, 3, 6, and 12 months after SAVR/TAVR. At baseline and each follow-up, they will undergo a set of standard and validated tests to assess physical function, health-related quality of life, and sleep quality.

Results: The ethics committee of Vicenza in Veneto Region in Italy approved the study (Protocol No. 943; January 4, 2019). As of October 2020, the enrollment of participants is ongoing.

Conclusions: The use of the wearable devices for real-time monitoring of physical activity of patients undergoing aortic valve replacement is a promising opportunity for improving the clinical management and consequently, the health outcomes of such patients.

Trial Registration: Clinicaltrials.gov NCT03843320; https://tinyurl.com/yyareu5y.

International Registered Report Identifier (irrid): DERR1-10.2196/20072.
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http://dx.doi.org/10.2196/20072DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7691084PMC
November 2020

Aortic valve replacement plus revascularization: The battle of surgical versus transcatheter approach still rages.

Catheter Cardiovasc Interv 2020 11;96(5):1126-1127

Department of Cardiac, Thoracic, Vascular Science and Public Health, University of Padova, Padova, Italy.

The current guidelines for primary aortic valve disease suggest, with different class of recommendation, concomitant coronary artery revascularization in all candidates to aortic valve replacement with angiographic evidence of significant coronary artery diameter stenosis (≥70%, ≥50% for left main stenosis) both for surgical or transcatheter approach. Initial (non-patient-level) pooled data analyses suggest that a percutaneous transcatheter approach confers similar outcomes compared to a surgical approach in patients with severe AS and CAD. Further scientific evidences from RCTs are warranted to clarify the prognostic impact of CAD on TAVR candidates and to identify the most appropriate revascularization strategy.
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http://dx.doi.org/10.1002/ccd.29350DOI Listing
November 2020

MitraClip in secondary mitral regurgitation as a bridge to heart transplantation: 1-year outcomes from the International MitraBridge Registry.

J Heart Lung Transplant 2020 12 17;39(12):1353-1362. Epub 2020 Sep 17.

Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands.

Background: Patients awaiting heart transplantation (HTx) often need bridging therapies to reduce worsening and progression of underlying disease. Limited data are available regarding the use of the MitraClip procedure in secondary mitral regurgitation for this clinical condition.

Methods: We evaluated an international, multicenter (17 centers) registry including 119 patients (median age: 58 years) with moderate-to-severe or severe secondary mitral regurgitation and advanced heart failure (HF) (median left ventricular ejection fraction: 26%) treated with MitraClip as a bridge strategy according to 1 of the following criteria: (1) patients active on HTx list (in list group) (n = 31); (2) patients suitable for HTx but awaiting clinical decision (bridge to decision group) (n = 54); or (3) patients not yet suitable for HTx because of potentially reversible relative contraindications (bridge to candidacy group) (n = 34).

Results: Procedural success was achieved in 87.5% of cases, and 30-day survival was 100%. At 1 year, Kaplan-Meier estimates of freedom from the composite primary end-point (death, urgent HTx or left ventricular assist device implantation, first rehospitalization for HF) was 64%. At the time of last available follow-up (median: 532 days), 15% of patients underwent elective transplant, 15.5% remained or could be included in the HTx waiting list, and 23.5% had no more indication to HTx because of clinical improvement.

Conclusions: MitraClip procedure as a bridge strategy to HTx in patients with advanced HF with significant mitral regurgitation was safe, and two thirds of patients remained free from adverse events at 1 year. These findings should be considered exploratory and hypothesis-generating to guide further study for percutaneous intervention in high-risk patients with advanced HF.
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http://dx.doi.org/10.1016/j.healun.2020.09.005DOI Listing
December 2020

Preprocedural anemia in females undergoing transcatheter aortic valve implantation: Insights from the WIN-TAVI registry.

Catheter Cardiovasc Interv 2021 Apr 1;97(5):E704-E715. Epub 2020 Oct 1.

Institut Hospitalier Jacques Cartier, Ramsay Générale de Santé, Massy, France.

Objectives: To assess the impact of anemia on clinical outcomes in female patients enrolled in the Women's InterNational transcatheter aortic valve implantation (WIN-TAVI) registry.

Background: Anemia is highly prevalent among females who constitute half of TAVI candidates, yet, its clinical significance remains poorly investigated.

Methods: Patients were divided into three groups according to preprocedural hemoglobin (Hb) level: (1) no anemia (Hb ≥12 g/dl), (2) mild-to-moderate anemia (10 ≤ Hb <12 g/dl), and (3) severe anemia (Hb <10 g/dl). The primary outcome was the occurrence of Valve Academic Research Consortium (VARC)-2 efficacy endpoint, a composite of mortality, stroke, myocardial infarction (MI), hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up.

Results: Hemoglobin level was available in 877 (86.1%) patients: 412 (47.0%) had no anemia, 363 (41.4%) had mild-to-moderate anemia, and 102 (11.6%) had severe anemia. The latter group had a higher prevalence of cardiovascular risk factors. Compared with patients without anemia, severe anemia was associated with a greater risk of VARC-2 efficacy endpoint ( HR 1.71, 95% CI: 1.02-2.87, p = .04), all-cause death ( HR 2.36, 95% CI: 1.31-4.26, p = .004) and a composite of death, MI or stroke ( HR 1.88, 95% CI: 1.10-3.22, p = .02) at 1 year. Moreover, an increased risk of late mortality ( HR 1.15, 95% CI: 1.02-1.30, p = .03) was observed with every 1 g/dl decrease in hemoglobin level.

Conclusion: Severe anemia in females undergoing TAVI was independently associated with increased rates of VARC-2 efficacy endpoint and mortality at 1 year.
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http://dx.doi.org/10.1002/ccd.29276DOI Listing
April 2021

Management of Valvular Disease During Pregnancy: Evolving Role of Percutaneous Treatment.

Interv Cardiol 2020 Apr 29;15:e10. Epub 2020 Jul 29.

Medico-Surgical Heart Valve Unit, Georges Pompidou European Hospital, University of Paris Paris, France.

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.
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http://dx.doi.org/10.15420/icr.2020.06DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7463339PMC
April 2020

Four-year mortality in women and men after transfemoral transcatheter aortic valve implantation using the SAPIEN 3.

Catheter Cardiovasc Interv 2021 Apr 4;97(5):876-884. Epub 2020 Sep 4.

Department of Cardiothoracic Surgery, King's College Hospital, London, UK.

Objectives: To investigate 4-year, post-transcatheter aortic valve implantation (TAVI) survival and predictors of survival by sex, in a real-world cohort that underwent transfemoral TAVI with SAPIEN 3 transcatheter heart valve.

Background: Previous TAVI investigations of first-generation devices demonstrated an early- to mid-term survival advantage in women compared with men.

Methods: SOURCE 3 (SAPIEN 3 Aortic Bioprosthesis European Outcome) is a post-approval, multicentre, observational registry. Patients (N = 1,694, 49.2% women, age 81.7 ± 6.7 years) with severe aortic stenosis and high surgical risk (logistic EuroSCORE 17.8%) underwent TAVI between 2014 and 2015. Kaplan-Meier event estimates were used to determine mortality by sex. Predictors of overall mortality were identified using a cox multivariate proportional hazard model.

Results: At 4 years, women had lower all-cause mortality than men (36.0 vs 39.7%; p = .0911; HR: 0.87 [95% CI: 0.75-1.02]). No difference was observed for cardiac mortality between women 24.2% and men 24.7% (p = .76; HR: 0.97 [95% CI: 0.79-1.19]). When adjusted for baseline characteristics (age, height, weight, NYHA functional class, renal insufficiency, EuroScore, and tricuspid regurgitation), sex had no impact on mortality.

Conclusions: In this large, real-world cohort, all-cause mortality trended lower in women than men at 4 years post TAVI; however, several baseline factors, but not sex, were predictors of mortality. No difference between sexes was observed for cardiovascular mortality.
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http://dx.doi.org/10.1002/ccd.29257DOI Listing
April 2021

Prevalence, predictors, and outcomes of patient prosthesis mismatch in women undergoing TAVI for severe aortic stenosis: Insights from the WIN-TAVI registry.

Catheter Cardiovasc Interv 2021 02 31;97(3):516-526. Epub 2020 Aug 31.

Center for Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, New York, Box 1030, USA.

Objective: To evaluate the incidence, predictors and outcomes of female patients with patient-prosthesis mismatch (PPM) following transcatheter aortic valve intervention (TAVI) for severe aortic stenosis (AS).

Background: Female AS TAVI recipients have a significantly lower mortality than surgical aortic valve replacement (SAVR) recipients, which could be attributed to the potentially lower PPM rates. TAVI has been associated with lower rates of PPM compared to SAVR. PPM in females post TAVI has not been investigated to date.

Methods: The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multicenter registry of women undergoing TAVR for severe symptomatic AS. Two hundred and fifty patients with detailed periprocedural and follow-up echocardiographic investigations were included in the WIN-TAVI echocardiographic sub-study. PPM was defined as per European guidelines stratified by the presence of obesity.

Results: The incidence of PPM in our population was 32.8%. Patients with PPM had significantly higher BMI (27.4 ± 6.1 vs. 25.2 ± 5.0, p = .002), smaller sized valves implanted (percentage of TAVI ≤23 mm 61% vs. 29.2%, PPM vs. no PPM, p < .001) and were more often treated with balloon expandable valves (48.3 vs. 32.5%, p < .001) rather than self expanding ones (26.3 vs. 52.8%, <.001). BMI (OR = 1.08; 95%CI 1.02-1.14, p = .011) and valve size ≤23 mm (OR = 3.00 95%CI 1.14-7.94, p = .027) were the only independent predictors of PPM. There was no significant interaction between valve size and valve type (p = .203). No significant differences were observed in 1-year mortality or major adverse cardiovascular events.

Conclusions: PPM in females undergoing TAVI occurs in one third of patients. BMI and valve size ≤23 mm are independent predictors. Larger registries are required to determine the impact of PPM on future clinical outcomes.
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http://dx.doi.org/10.1002/ccd.29227DOI Listing
February 2021

Impact of diabetes mellitus on female subjects undergoing transcatheter aortic valve implantation: Insights from the WIN-TAVI international registry.

Int J Cardiol 2021 01 16;322:65-69. Epub 2020 Aug 16.

San Raffaele Scientific Institute, Milan, Italy.

Background: Female subjects constitute half of all transcatheter aortic valve implantation (TAVI) candidates, but the association between important comorbidities such as diabetes mellitus (DM) and clinical outcomes after TAVI remains unclear in this group.

Method: WIN-TAVI is a real-world international registry of exclusively female subjects undergoing TAVI. The study population was stratified into those with (DM) and those without DM (NDM). Valve Academic Research Consortium (VARC)-2 efficacy (composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or worsening congestive heart failure, or valve-related dysfunction) was the primary endpoint for this analysis.

Results: Of the 1012 subjects included in this study, 264 (26.1%) had DM at baseline. DM patients were younger but had a higher burden of comorbidities. There were no differences in VARC-2 efficacy events between DM and NDM patients at 30 days or 1 year. Conversely, patients with DM had a lower risk of VARC-2 life threatening bleeding at 30 days and 1 year after TAVI compared to NDM patients, which remained significant even after multivariable adjustment (HR, 0.34, 95% CI, 0.12-0.99; p = .047). In the subgroup analysis, insulin-dependent DM was not associated with an increased risk of adverse outcomes.

Conclusions: Among female patients undergoing TAVI, more than one-fourth of the subjects presented with DM. At 1-year follow-up, DM was associated with lower bleeding complications and no increase in the risk of other adverse events, including mortality, after TAVI.
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http://dx.doi.org/10.1016/j.ijcard.2020.08.035DOI Listing
January 2021

Transcatheter aortic valve implantation (TAVI) in cardiogenic shock: TAVI-shock registry results.

Catheter Cardiovasc Interv 2020 11 6;96(5):1128-1135. Epub 2020 Jul 6.

Interventional Cardiology Unit, Department of Cardiac, Thoracic and Vascular Sciences and Public Health, University of Padua, Padua, Italy.

Objectives: Aim of this study is to evaluate safety, feasibility, and mid-term outcome of transcatheter aortic valve implantation (TAVI) in cardiogenic shock (CS).

Background: Balloon aortic valvuloplasty in patients with severe aortic valve stenosis (SAS) complicated by CS is indicated but associated with a grim prognosis. TAVI might be a more reasonable treatment option in this setting but data are scant.

Methods: From March 2008 to February 2019, 51 patients with severe aortic valvulopathy (native SAS or degenerated aortic bioprosthesis) and CS treated by TAVI in 11 European centers were included in this multicenter registry. Demographic, clinical, and procedural data were collected, as well as clinical and echocardiographic follow-up.

Results: The mean age of our study population was 75.8 ± 13, 49% were women, and mean Society of Thoracic Surgeons (STS) score was 19 ± 15%. Device success was achieved in 94.1%, with a 5% incidence of moderate/severe paravalvular leak. The 30-day events were mortality 11.8%, stroke 2.0%, vascular complications 5.9%, and acute kidney injury 34%. Valve Academic Research Consortium-2 early safety endpoint was reached in 35.3% of cases. At 1-year of follow-up, the mortality rate was 25.7% and the readmission for congestive heart failure was 8.6%.

Conclusions: TAVI seems to be a therapeutic option for patients with CS and SAS or degenerated aortic bioprosthesis in terms of both safety and efficacy at early and long-term follow-up.
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http://dx.doi.org/10.1002/ccd.29112DOI Listing
November 2020

An EAPCI Expert Consensus Document on Ischaemia with Non-Obstructive Coronary Arteries in Collaboration with European Society of Cardiology Working Group on Coronary Pathophysiology & Microcirculation Endorsed by Coronary Vasomotor Disorders International Study Group.

Eur Heart J 2020 10;41(37):3504-3520

Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London and Barts Heart Centre, London, UK.

This consensus document, a summary of the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI), appraises the importance of ischaemia with non-obstructive coronary arteries (INOCA). Angina pectoris affects approximately 112 million people globally. Up to 70% of patients undergoing invasive angiography do not have obstructive coronary artery disease, more common in women than in men, and a large proportion have INOCA as a cause of their symptoms. INOCA patients present with a wide spectrum of symptoms and signs that are often misdiagnosed as non-cardiac leading to under-diagnosis/investigation and under-treatment. INOCA can result from heterogeneous mechanism including coronary vasospasm and microvascular dysfunction and is not a benign condition. Compared to asymptomatic individuals, INOCA is associated with increased incidence of cardiovascular events, repeated hospital admissions, as well as impaired quality of life and associated increased health care costs. This consensus document provides a definition of INOCA and guidance to the community on the diagnostic approach and management of INOCA based on existing evidence from research and best available clinical practice; noting gaps in knowledge and potential areas for further investigation.
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http://dx.doi.org/10.1093/eurheartj/ehaa503DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7577516PMC
October 2020

An EAPCI Expert Consensus Document on Ischaemia with Non-Obstructive Coronary Arteries in Collaboration with European Society of Cardiology Working Group on Coronary Pathophysiology & Microcirculation Endorsed by Coronary Vasomotor Disorders International Study Group.

EuroIntervention 2021 Jan;16(13):1049-1069

Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University and Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.

This consensus document, a summary of the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI), appraises the importance of ischaemia with non-obstructive coronary arteries (INOCA). Angina pectoris affects approximately 112 million people globally. Up to 70% of patients undergoing invasive angiography do not have obstructive coronary artery disease, more common in women than in men, and a large proportion have INOCA as a cause of their symptoms. INOCA patients present with a wide spectrum of symptoms and signs that are often misdiagnosed as non-cardiac leading to under-diagnosis/investigation and under-treatment. INOCA can result from heterogeneous mechanism including coronary vasospasm and microvascular dysfunction and is not a benign condition. Compared to asymptomatic individuals, INOCA is associated with increased incidence of cardiovascular events, repeated hospital admissions, as well as impaired quality of life and associated increased health care costs. This consensus document provides a definition of INOCA and guidance to the community on the diagnostic approach and management of INOCA based on existing evidence from research and best available clinical practice; noting gaps in knowledge and potential areas for further investigation.
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http://dx.doi.org/10.4244/EIJY20M07_01DOI Listing
January 2021

Coronary Angiography After Transcatheter Aortic Valve Replacement (TAVR) to Evaluate the Risk of Coronary Access Impairment After TAVR-in-TAVR.

J Am Heart Assoc 2020 07 24;9(13):e016446. Epub 2020 Jun 24.

Department of Cardiac, Thoracic, Vascular Sciences and Public Health University of Padua Medical School Padua Italy.

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 THVs 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; <0.001), theoretically feasible in 27.7% (8.3%, 42.3%, and 53.8%, respectively; <0.001), and unfeasible in 31.4% (23.6%, 38.5%, and 41.1%, respectively; =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; =0.040), sinotubular junction diameter (OR, 0.62; 95% CI, 0.48-0.80; <0.001), and implantation of a supra-annular THV (OR, 6.61; 95% CI, 1.98-22.03; =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.
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http://dx.doi.org/10.1161/JAHA.120.016446DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7670517PMC
July 2020

Editorial: Structural Valve Degeneration and Failure in Transcatheter and Surgical Bioprosthesis.

Front Cardiovasc Med 2020 21;7:58. Epub 2020 Apr 21.

Interventional Cardiology Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University Hospital of Padua, Padua, Italy.

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http://dx.doi.org/10.3389/fcvm.2020.00058DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7186297PMC
April 2020

Repeat Transcatheter Aortic Valve Replacement for Transcatheter Prosthesis Dysfunction.

J Am Coll Cardiol 2020 04;75(16):1882-1893

Herzzentrum Duisburg, Duisburg, Germany.

Background: Transcatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR may play a key strategy in treating patients in whom THVs fail.

Objectives: The authors sought to examine outcomes following redo-TAVR.

Methods: The Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively.

Results: Among 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis-regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm and 1.51 ± 0.57 cm; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke [1.4%], 7 valve malposition [3.3%], 2 coronary obstruction [0.9%], 20 new permanent pacemaker [9.6%], no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively.

Conclusions: Redo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.
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http://dx.doi.org/10.1016/j.jacc.2020.02.051DOI Listing
April 2020

[Position paper of the Italian Society of Interventional Cardiology (SICI-GISE): Management of patent foramen ovale in patients with cerebral or systemic thromboembolism - 2020].

G Ital Cardiol (Rome) 2020 04;21(4 Suppl 2):50S-59S

U.O.C. Emodinamica, P.O. San Filippo Neri, ASL Roma 1, Roma.

Patent foramen ovale (PFO) is implicated in the pathogenesis of different clinical syndromes in which it plays variable roles. In 2017 and 2018, four randomized clinical trials were published, allowing for the clarification of certain issues pertaining to cryptogenic stroke. Recently, eight European scientific societies collaborated to the writing of an interdisciplinary international position paper on PFO and cryptogenic stroke, based upon best available evidence, with the aim of defining the principles needed to guide decision making. Nonetheless, a tailored approach is not suitably addressed by standard position documents, considering that decisions about optimal management of PFO patients with left circulation thromboembolism are often challenging, mostly due to comorbidities and complex clinical scenarios.A panel of Italian cardiology experts gathered under the auspices of the Italian Society of Interventional Cardiology (SICI-GISE) for comprehensive discussion and consensus development, with the aim of providing practical recommendations, for both clinical and interventional cardiologists, regarding optimal management of PFO in patients with cerebral or systemic thromboembolism. In this position paper, various clinical scenarios in patients with and without high-risk PFO features are presented and discussed, including PFO patients with associated conditions (e.g. hypercoagulable states, deep vein thrombosis/pulmonary embolism, short runs of atrial fibrillation), and special subsets (e.g. patients with risk factors for atrial fibrillation, patients aged ≥65 years, patients who refused percutaneous PFO closure), with the Panel's recommendations being provided for each scenario.
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http://dx.doi.org/10.1714/3336.33075DOI Listing
April 2020

[Presentation].

G Ital Cardiol (Rome) 2020 Apr;21(4 Suppl 2):3S-4S

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http://dx.doi.org/10.1714/3336.33067DOI Listing
April 2020

Italian Society of Interventional Cardiology (GISE) position paper for Cath lab-specific preparedness recommendations for healthcare providers in case of suspected, probable or confirmed cases of COVID-19.

Catheter Cardiovasc Interv 2020 10 11;96(4):839-843. Epub 2020 Apr 11.

Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.

COVID-19 pandemic raised the issue to guarantee the proper level of care to patients with acute cardiovascular diseases and concomitant suspected or confirmed COVID-19 and, in the meantime safety and protection of healthcare providers. The aim of this position paper is to provide standards to healthcare facilities and healthcare providers on infection prevention and control measures during the management of suspected and confirmed cases of 2019-nCoV infection accessing in cath-lab. The document represents the view of the Italian Society of Interventional Cardiology (GISE), and it is based on recommendations from the main World and European Health Organizations (WHO, and ECDC) as well as from the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI).
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http://dx.doi.org/10.1002/ccd.28888DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7228289PMC
October 2020
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