Publications by authors named "Giuseppe Tarantini"

473 Publications

Annular size and interaction with trans-catheter aortic valves for treatment of severe bicuspid aortic valve stenosis: Insights from the BEAT registry.

Int J Cardiol 2021 Nov 26. Epub 2021 Nov 26.

Clinical and Interventional Cardiology Unit, Istituto Clinico Sant'Ambrogio, Milan, Italy.

Background: Transcatheter aortic valve replacement (TAVR) is safe and feasible in patients with bicuspid aortic valve (BAV), but whether annular size may influence TAVR results in BAV patients remains unclear. We aimed at evaluating the impact of aortic annular size on procedural and clinical outcomes of BAV patients undergoing TAVR, as well as potential interactions between annular dimension and trans-catheter heart valve (THV) type (balloon-expandable (BEV) vs. self-expanding (SEV).

Methods: BEAT is a multicenter registry of consecutive BAV stenosis undergoing TAVR. For this sub-study patients were classified according to annular dimension in small-annulus (area < 400 mm or perimeter <72 mm), medium-annulus (area ≥ 400 and < 575 mm, perimeter ≥72 mm and< 85 mm), large-annulus (area ≥ 575 mm or perimeter ≥85 mm). Primary endpoint was Valve Academic Research Consortium-2 (VARC-2) device success.

Results: 45(15.5%) patients had small, 132(45.3%) medium, and 114(39.2%) large annuli. Compared with other groups, patients with large annuli were more frequently male, younger, with higher body mass index, larger aortic valve area, higher rate of moderate-severe calcification, lower mean trans-aortic valve gradient and lower left ventricular ejection fraction. In large-annuli SEVs were associated with a lower VARC-2 device success (75.9% vs. 90.6%, p = 0.049) driven by a higher rate of paravalvular valvular leak (PVL) compared to BEVs (20.7% vs. 1.2%, p < 0.001). However, no differences in clinical outcomes were observed according to annular size nor THV type.

Conclusions: TAVR in BAV patients is feasible irrespective of annular size. However in patients with large aortic annulus SEVs were associated with a significantly higher rate of PVLs compared to BEVs.
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http://dx.doi.org/10.1016/j.ijcard.2021.11.055DOI Listing
November 2021

Clinical outcomes of transcatheter aortic valve implantation in patients younger than 70 years rejected for surgery: the AMTRAC registry.

EuroIntervention 2021 Oct 22. Epub 2021 Oct 22.

Division of Cardiology, Rabin Medical Centre, Petah-Tikva, Israel.

Background: The mean age of transcatheter aortic valve implantation (TAVI) patients is steadily decreasing.

Aims: The aim of the study was to describe the characteristics, the indications for and the outcomes of TAVI in patients <70 years old.

Methods: All patients undergoing TAVI (n=8,626) from the 18 participating centres between January 2007 and June 2020 were stratified by age (</> 70). For patients <70, the indications for TAVI were extracted from Heart Team discussions and the baseline characteristics and mortality were compared between the two groups.

Results: Overall, 640 (7.4%) patients were <70 (9.1% during 2018-2020, p<0.001); the mean age was 65.0±2.3 years. The younger patients were more often male, with bicuspid valves or needing valve-in-valve procedures. They had a higher prevalence of lung disease and diabetes. In 80.7% of cases, the Heart Team estimated an increased surgical risk and TAVI was selected, reflected by an STS score >4% in 20.4%. Five-year mortality was similar (29.4 vs 29.8%, HR 0.95, p=0.432) in the <70 and >70 groups. In the <70 group, mortality was higher for those referred for TAVI due to an increased surgical risk compared to those referred for other reasons (31.6 vs 24.5%, HR 1.23, p=0.021). Mortality was similar regardless of the STS stratum in patients judged by the Heart Team to be at increased surgical risk (32.6 vs 30.4%, HR 0.98, p=0.715).

Conclusions: Use of TAVI in patients <70 is becoming more frequent. The main reason for choosing TAVI is due to an increased surgical risk not adequately represented by the STS score. The outcomes for these patients are similar to those for older TAVI patients. Dedicated trials of TAVI/SAVR in younger patients are needed to guide decisions concerning expansion of TAVI indications. (NCT04031274).
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http://dx.doi.org/10.4244/EIJ-D-21-00613DOI Listing
October 2021

Transcatheter aortic valve implantation in degenerated surgical aortic valves.

EuroIntervention 2021 Oct;17(9):709-719

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

Transcatheter aortic valve implantation (TAVI) within failed bioprosthetic surgical aortic valves (valve-in-valve TAVI) has become an established procedure, currently approved for patients deemed at high risk for repeat aortic valve intervention. Although less invasive than surgical reoperation, challenges of valve-in-valve treatment include higher rates of malposition, prosthesis-patient mismatch and coronary obstruction. Thus, optimal patient selection and preprocedural planning is of the utmost importance to minimise the risk of these complications. In this review article we provide a fully illustrated overview of the most significant periprocedural operative considerations for valve-in-valve TAVI.
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http://dx.doi.org/10.4244/EIJ-D-21-00157DOI Listing
October 2021

Bioprosthetic valve fracture for aortic valve-in-valve procedures: Handle with care-extra weapon.

Catheter Cardiovasc Interv 2021 10;98(4):765-766

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

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http://dx.doi.org/10.1002/ccd.29908DOI Listing
October 2021

Balloon-Expandable versus Self-Expandable Valves in Transcatheter Aortic Valve Implantation: Complications and Outcomes from a Large International Patient Cohort.

J Clin Med 2021 Sep 4;10(17). Epub 2021 Sep 4.

Heart Center, Amsterdam UMC, Department of Cardiology, University of Amsterdam, Amsterdam Cardiovascular Sciences, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.

Background: Both balloon-expandable (BE) and self-expandable (SE) valves for transcatheter aortic valve implantation (TAVI) are broadly used in clinical practice. However, adequately powered randomized controlled trials comparing these two valve designs are lacking.

Methods: The CENTER-study included 12,381 patients undergoing transfemoral TAVI. Patients undergoing TAVI with a BE-valve ( = 4096) were compared to patients undergoing TAVI with an SE-valve ( = 4096) after propensity score matching. Clinical outcomes including one-year mortality and stroke rates were assessed.

Results: In the matched population of = 5410 patients, the mean age was 81 ± 3 years, 60% was female, and the STS-PROM predicted 30-day mortality was 6.2% (IQR 4.0-12.4). One-year mortality was not different between patients treated with BE- or SE-valves (BE: 16.4% vs. SE: 17.0%, Relative Risk 1.04, 95%CI 0.02-1.21, = 0.57). One-year stroke rates were also comparable (BE: 4.9% vs. SE: 5.3%, RR 1.09, 95%CI 0.86-1.37, = 0.48).

Conclusion: This study suggests that one-year mortality and stroke rates were comparable in patients with severe aortic valve stenosis undergoing TAVI with either BE or SE-valves.
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http://dx.doi.org/10.3390/jcm10174005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8432462PMC
September 2021

Percutaneous coronary intervention versus coronary artery bypass graft surgery: The battle rages on.

Catheter Cardiovasc Interv 2021 09;98(3):434-435

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

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http://dx.doi.org/10.1002/ccd.29883DOI Listing
September 2021

Outcomes of 10,312 patients treated with everolimus-eluting bioresorbable scaffolds during daily clinical practice - results from the European Absorb Consortium.

Catheter Cardiovasc Interv 2021 Aug 31. Epub 2021 Aug 31.

Medizinische Klinik I, University of Giessen, Giessen, Germany.

Objectives: To asses mid-term clinical outcomes of bioresorbable vascular scaffolds (BVS) for the treatment of coronary artery disease in a large-scale all-comers population.

Background: Several clinical settings are underrepresented in randomized studies investigating BVS against drug-eluting stents. Whether their results can be translated into the heterogeny patient population seen during daily routine requires further investigation.

Methods: The European ABSORB Consortium comprises the following European registries: GABI-R, ABSORB UK Registry, ABSORB France, BVS RAI Registry, and REPARA BVS Registry, which all prospectively collected patient-level data regarding outcomes following unrestricted BVS implantation. The primary endpoint of target lesion failure (TLF) includes cardiac death, target-vessel myocardial infarction (TVMI) and target-lesion revascularisation (TLR) at 12 months. The incidence of scaffold thrombosis (ST) according to ARC criteria was also assessed. Multivariable analysis was used to adjust for differences in patient and lesion characteristics.

Results: A total of 10,312 patients (mean age 58.4 ± 11.4 y) underwent BVS implantation during routine practice. The 12-month follow-up was complete in 95.5% of patients. At 12 months, the primary endpoint of TLF occurred in 3.6%; its components cardiac death, TVMI and TLR were documented in 1.2%, 1.8%, and 2.6%, respectively. The definite/probable ST rate was 1.7%. Absence of predilatation, discontinuation of DAPT and scaffold diameter below 3 mm were independent predictors of ST.

Conclusions: The EAC demonstrates reasonable real-world clinical outcome data after BVS implantation. However, the rate of scaffold thrombosis remains high.
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http://dx.doi.org/10.1002/ccd.29932DOI Listing
August 2021

Sleep Quality in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI).

Int J Environ Res Public Health 2021 08 23;18(16). Epub 2021 Aug 23.

Interventional Cardiology Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, 35128 Padova, Italy.

The present study aimed to analyze sleep quality and quality of Life (QoL) in patients undergoing Transcatheter Aortic Valve Implantation (TAVI). It was conducted at the Interventional Cardiology Unit of the Department of Cardiac, Thoracic, Vascular Sciences and Public Health of the University of Padova on 27 adult patients who underwent TAVI via the transfemoral approach. Patients completed two validated instruments, i.e., the Pittsburgh Sleep Quality Index (PSQI) and the EuroQoL (EQ-5D-5L), on the day of discharge and one month after the hospital discharge. Twenty-seven patients were enrolled with a severe aortic stenosis diagnosis, treated with transfemoral TAVI procedure. The study population included seventeen poor sleepers and ten good sleepers with a median age of 81.92 years overall. The global PSQI evaluation revealed a small significant improvement at follow-up (-value 0.007). Small positive changes were detected in the Self-care and Usual activity domains of the EQ-5D-5L and the EQ-VAS. No correlation was detected between EQ-5D-5L and sleep quality. The present study confirms the importance of sleep quality monitoring in patients who undergo TAVI procedure for aortic stenosis treatment.
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http://dx.doi.org/10.3390/ijerph18168889DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8395069PMC
August 2021

One-Year Outcomes after Surgical versus Transcatheter Aortic Valve Replacement with Newer Generation Devices.

J Clin Med 2021 Aug 20;10(16). Epub 2021 Aug 20.

Division of Cardiology, A.O.U. Policlinico "G. Rodolico-San Marco", University of Catania, 95124 Catania, Italy.

The superiority of transcatheter (TAVR) over surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS) has not been fully demonstrated in a real-world setting. This prospective study included 5706 AS patients who underwent SAVR from 2010 to 2012 and 2989 AS patients who underwent TAVR from 2017 to 2018 from the prospective multicenter observational studies OBSERVANT I and II. Early adverse events as well as all-cause mortality, major adverse cardiac and cerebrovascular events (MACCEs), and hospital readmission due to heart failure at 1-year were investigated. Among 1008 propensity score matched pairs, TAVR was associated with significantly lower 30-day mortality (1.8 vs. 3.5%, = 0.020), stroke (0.8 vs. 2.3%, = 0.005), and acute kidney injury (0.6 vs. 8.2%, < 0.001) compared to SAVR. Moderate-to-severe paravalvular regurgitation (5.9 vs. 2.0%, < 0.001) and permanent pacemaker implantation (13.8 vs. 3.3%, < 0.001) were more frequent after TAVR. At 1-year, TAVR was associated with lower risk of all-cause mortality (7.9 vs. 11.5%, = 0.006), MACCE (12.0 vs. 15.8%, = 0.011), readmission due to heart failure (10.8 vs. 15.9%, < 0.001), and stroke (3.2 vs. 5.1%, = 0.033) compared to SAVR. TAVR reduced 1-year mortality in the subgroups of patients aged 80 years or older (HR 0.49, 95% CI 0.33-0.71), in females (HR 0.57, 0.38-0.85), and among patients with EuroSCORE II ≥ 4.0% (HR 0.48, 95% CI 0.32-0.71). In a real-world setting, TAVR using new-generation devices was associated with lower rates of adverse events up to 1-year follow-up compared to SAVR.
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http://dx.doi.org/10.3390/jcm10163703DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8396948PMC
August 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

The rescue snared wire technique for challenging transcatheter pulmonary valve implantation: a case series of two patients.

Eur Heart J Case Rep 2021 Jul 26;5(7):ytab135. Epub 2021 Jul 26.

Department of Women and Children's Health, University of Padua Medical School, Via Giustiniani 2, 35128 Padua, Italy.

Background: Transcatheter pulmonary valve implantation (TPVI) is an effective treatment for right ventricular outflow tract (RVOT) dysfunction. Patients affected by congenital heart disease requiring TPVI may have difficult anatomies, thus making the intervention technically demanding.

Case Summary: We report a case series of two patients affected by RVOT dysfunction. Both the cases were characterized by difficulty to advance the valve over the wire, which was successfully overcome by the application of the snared wire technique (SWT) to TPVI.

Discussion: Various technical pitfalls and tips have been described to facilitate the delivery of the transcatheter Edwards Sapien valve in the pulmonary position. The SWT described by the authors may be a helpful tool to gain supportiveness and stability of the guidewire during the procedure.
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http://dx.doi.org/10.1093/ehjcr/ytab135DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8343437PMC
July 2021

Characteristics and outcomes of MitraClip in octogenarians: Evidence from 1853 patients in the GIOTTO registry.

Int J Cardiol 2021 Nov 8;342:65-71. Epub 2021 Aug 8.

Division of Cardiology, AOU Policlinico "G. Rodolico - San Marco", Università di Catania, Catania, Italy.

Background: We aimed at appraising features and outcomes of patients undergoing MitraClip treatment according to their age.

Methods: We queried the prospective GIse registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) multicenter registry dataset including 19 Italian centers performing MitraClip implantation, distinguishing patients <80 vs ≥80 years of age.

Results: In total, 1853 patients were included, 751 (40.5%) octogenarians and 1102 (59.5%) non-octogenarians. Several baseline and procedural features were significantly different, including gender, regurgitation etiology, and functional class (all p < 0.05). In-hospital outcomes were similarly satisfactory, with death occurring in 18 (2.4%) and 32 (2.9%, p = 0.561), respectively, and improvement in mitral regurgitation in 732 (97.4%) and 1078 (97.8%, p = 0.746), respectively. After a mean follow-up of 15 months, death occurred in 152 (20.2%) and 264 (24.0%), and cardiac death in 85 (11.3%) and 138 (12.5%), respectively (both p > 0.05). Rehospitalization for heart failure and the composite of cardiac death or rehospitalization for heart failure were significantly less common in octogenarians: 63 (8.4%) vs 156 (14.2%, p < 0.001), and 125 (16.6%) vs 242 (22.0%, p = 0.005), respectively. Multivariable analysis showed that these differences were largely due to confounding features, as after adjustment for baseline, clinical and imaging characteristics no significant difference was found for the above clinical endpoints.

Conclusions: Transcatheter mitral valve repair with the MitraClip in carefully selected octogenarians appears feasible and safe, and is associated with favorable clinical outcomes at mid-term follow-up.
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http://dx.doi.org/10.1016/j.ijcard.2021.08.010DOI Listing
November 2021

Transcatheter aortic valve replacement and chronic kidney disease: Close friends or sworn enemies?

Catheter Cardiovasc Interv 2021 08;98(2):328-329

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

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http://dx.doi.org/10.1002/ccd.29854DOI Listing
August 2021

Lifetime Strategy of Patients With Aortic Stenosis: The First Cut Is the Deepest.

JACC Cardiovasc Interv 2021 08;14(15):1727-1730

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

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http://dx.doi.org/10.1016/j.jcin.2021.06.029DOI Listing
August 2021

Transcatheter Therapies in Challenging Aortic Ailments: TAVR in Extreme Horizontal Aortic Root With CoA Stenting.

JACC Case Rep 2021 Jun 16;3(6):905-909. Epub 2021 Jun 16.

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

Transcatheter aortic valve replacement (TAVR) for severe aortic stenosis in older adults may be challenging because of additional aortic comorbidities such as aortic coarctation (CoA). We report successful snared-assisted transfemoral TAVR in a patient with an extremely horizontal ventriculoaortic axis that was worsened by a previous endovascular repair of complex CoA. ().
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http://dx.doi.org/10.1016/j.jaccas.2021.04.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8311283PMC
June 2021

Left Atrial Expansion Index for Noninvasive Estimation of Pulmonary Capillary Wedge Pressure: A Cardiac Catheterization Validation Study.

J Am Soc Echocardiogr 2021 Dec 24;34(12):1242-1252. Epub 2021 Jul 24.

Department of Medicine and Surgery, University Milano-Bicocca, Milan, Italy; Department of Cardiac, Neural and Metabolic Sciences, Istituto Auxologico Italiano, IRCCS, Milan, Italy.

Background: Pulmonary capillary wedge pressure (PCWP) plays a pivotal role in cardiac disease diagnosis and management. Right heart catheterization (RHC) invasively provides accurate PCWP measurement, but it is impractical for widespread use in all patients. The left atrial expansion index (LAEI), measured on transthoracic echocardiography, describes the relative left atrial volume increase during the left atrial reservoir phase. The aim of this study was to validate LAEI as a noninvasive parameter for PCWP estimation.

Methods: A total of 649 chronic cardiac patients (mean age, 66 ± 14 years; mean PCWP, 14 ± 7.6 mm Hg; mean left ventricular ejection fraction, 50 ± 15%) who underwent both clinically indicated RHC and transthoracic echocardiography within 24 hours were retrospectively enrolled. Patients were randomly divided into derivation (n = 509) and validation (n = 140) cohorts. PCWP was measured during RHC and defined as elevated when >12 mm Hg. Transthoracic echocardiographic parameters and LAEI were measured offline, blinded to RHC results.

Results: In the derivation cohort, LAEI correlated logarithmically with PCWP, and the log-transformed LAEI (lnLAEI) correlated linearly with PCWP (r = -0.73, P < .001). lnLAEI showed an independent and additive predictive role for PCWP estimation over clinical and diastolic dysfunction (DD) parameters. The diagnostic accuracy of lnLAEI for elevated PCWP identification (area under the curve = 0.875, P < .001; optimal lnLAEI cutoff < 4.02) was higher than either the single DD parameters or their combination. In the validation cohort, lnLAEI cutoff < 4.02 showed higher accuracy than the 2016 DD algorithm (88% vs 74%) for elevated PCWP identification. Finally, the equation PCWP = 38.3 - 6.2 × lnLAEI, obtained from the derivation cohort, predicted invasively measured PCWP in the validation cohort.

Conclusions: In a cohort of patients with various chronic cardiac diseases, lnLAEI performed better than DD parameters and the 2016 DD algorithm for PCWP estimation. lnLAEI might be a useful echocardiographic parameter for noninvasive PCWP estimation.
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http://dx.doi.org/10.1016/j.echo.2021.07.009DOI Listing
December 2021

Implantation of one, two or multiple MitraClips for transcatheter mitral valve repair: insights from a 1824-patient multicenter study.

Panminerva Med 2021 Jul 26. Epub 2021 Jul 26.

Division of Cardiology, Centro Alte Specialità e Trapianti (CAST), Azienda Ospedaliero-Universitaria Policlinico-Vittorio Emanuele, University of Catania, Catania, Italy.

Background: Transcatheter mitral valve repair (TMVR) with the MitraClip device is an established treatment for mitral regurgitation (MR). More than one MitraClip may be implanted if a single one does not reduce MR adequately. We aimed at appraising the outlook of patients undergoing implantation of one, two or multiple MitraClips for TMVR.

Methods: Exploiting the ongoing prospective GIse registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) Study dataset, we compared patients, procedural details and outcomes distinguishing those receiving one, two or multiple MitraClips. The primary endpoint was the composite of 1-year cardiac death or rehospitalization for heart failure. Additional endpoints included all cause death, surgical mitral repair, and functional class. Multivariable adjusted Cox proportional hazard analysis was used for confirmatory purposes.

Results: As many as 1824 patients were included: 718 (39.4%) treated with a single MitraClip, and 940 (51.5%) receiving two MitraClips, and 166 (9.1%) receiving three or more. Significant differences were found for baseline features, including age, female gender, diabetes mellitus, hypertension, chronic obstructive pulmonary disease, prior myocardial infarction, atrial fibrillation, permanent pacemaker, cardiac resynchronization therapy, implantable cardioverter defibrillator, and prior mitral valve repair (all p<0.05). Several imaging features were also different, including left ventricular dimensions, MR severity and proportionality, mitral valve area, flail leaflet, and pulmonary vein flow (all p<0.05). Among procedural features, significant differences were found for anesthesia type, MitraClip type, fluoroscopy, device, and operating room times, postprocedural mitral gradient, residual MR, smoke-like effect, device success partial detachment and surgical conversion (all p<0.05). In-hospital death occurred more frequently in patients receiving multiple MitraClips, and the same applied severe residual MR (all p<0.05). Mid-term follow-up (15±13 months) showed significant difference in the risk of death, cardiac death, rehospitalization for heart failure, and their composites, mainly, but not solely, associated with multiple MitraClips (all p<0.05). Adjusted analysis confirmed the significantly increased risk of composite adverse events when comparing the multiple vs single MitraClip groups (p=0.014 for death and rehospitalization, p=0.013 for cardiac death or rehospitalization).

Conclusions: Implantation of one or two MitraClips is associated with favorable clinical outcomes. Conversely, bail-out implantation of three or more MitraClips may portend a worse long-term prognosis.
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http://dx.doi.org/10.23736/S0031-0808.21.04497-9DOI Listing
July 2021

Complete Revascularisation in Impella-Supported Infarct-Related Cardiogenic Shock Patients Is Associated With Improved Mortality.

Front Cardiovasc Med 2021 9;8:678748. Epub 2021 Jul 9.

Department of Cardiology, University Heart Center, Bonn, Germany.

Acute myocardial infarction-related cardiogenic shock (AMI-CS) still has high likelihood of in-hospital mortality. The only trial evidence currently available for the intra-aortic balloon pump showed no benefit of its routine use in AMI-CS. While a potential benefit of complete revascularisation has been suggested in urgent revascularisation, the CULPRIT-SHOCK trial demonstrated no benefit of multivessel compared to culprit-lesion only revascularisation in AMI-CS. However, mechanical circulatory support was only used in a minority of patients. We hypothesised that more complete revascularisation facilitated by Impella support is related to lower mortality in AMI-CS patients. We analysed data from 202 consecutive Impella-treated AMI-CS patients at four European high-volume shock centres (age 66 ± 11 years, 83% male). Forty-seven percentage ( = 94) had cardiac arrest before Impella implantation. Revascularisation was categorised as incomplete if residual SYNTAX-score (rS) was >8. Overall 30-day mortality was 47%. Mortality was higher when Impella was implanted post-PCI (Impella-post-PCI: 57%, Impella-pre-PCI: 38%, = 0.0053) and if revascularisation was incomplete (rS ≤ 8: 37%, rS > 8: 56%, = 0.0099). Patients with both pre-PCI Impella implantation and complete revascularisation had significantly lower mortality (33%) than those with incomplete revascularisation and implantation post PCI (72%, < 0.001). Our retrospective analysis suggests that complete revascularisation supported by an Impella microaxial pump implanted prior to PCI is associated with lower mortality than incomplete revascularisation in patients with AMI-CS.
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http://dx.doi.org/10.3389/fcvm.2021.678748DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8299360PMC
July 2021

Monitoring Patients Reported Outcomes after Valve Replacement Using Wearable Devices: Insights on Feasibility and Capability Study: Feasibility Results.

Int J Environ Res Public Health 2021 07 4;18(13). Epub 2021 Jul 4.

Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, 35121 Padova, Italy.

Wearable devices (WDs) can objectively assess patient-reported outcomes (PROMs) in clinical trials. In this study, the feasibility and acceptability of using commercial WDs in elderly patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) will be explored. This is a prospective observational study. Participants were trained to use a WD and a smartphone to collect data on their physical activity, rest heart rate and number of hours of sleep. Validated questionnaires were also used to evaluate these outcomes. A technology acceptance questionnaire was used at the end of the follow up. In our participants an overall good compliance in wearing the device (75.1% vs. 79.8%, SAVR vs. TAVR) was assessed. Half of the patients were willing to continue using the device. Perceived ease of use is one of the domains that scored higher in the technology acceptance questionnaire. In this study we observed that the use of a WD is accepted in our frail population for an extended period. Even though commercial WDs are not tailored for clinical research, they can produce useful information on patient behavior, especially when coordinated with intervention tailored to the single patient.
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http://dx.doi.org/10.3390/ijerph18137171DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8297062PMC
July 2021

New DyeVert system for contrast media volume reduction in percutaneous procedures: "Make kidney safe again".

Catheter Cardiovasc Interv 2021 07;98(1):85-86

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

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http://dx.doi.org/10.1002/ccd.29810DOI Listing
July 2021

Transcatheter Aortic Valve Replacement for Bicuspid Aortic Valve Stenosis: A Practical Operative Overview.

Circ Cardiovasc Interv 2021 07 16;14(7):e009827. Epub 2021 Jun 16.

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

The bicuspid aortic valve (BAV) represents a complex anatomic scenario for transcatheter aortic valve replacement (TAVR) because of its unique technical challenges. As TAVR is moving towards younger and lower-risk populations, the proportion of BAV patients undergoing TAVR is expected to rise. Initial experiences of TAVR with first-generation transcatheter heart valves in high surgical risk patients with BAV stenosis showed higher rates of device failure and periprocedural complications as compared to tricuspid anatomy. The subsequent advances in imaging techniques and understanding of BAV anatomy, new iterations of transcatheter heart valves, and growing operators' experience yielded better outcomes. However, in the lack of randomized trials and rigorous evidence, the field of TAVR in BAV has been driven by empirical observations, with wide variability in transcatheter heart valve sizing and implantation techniques across different centers and operators. Thus, in this review article, we provide a fully illustrated overview of operative periprocedural steps for TAVR in BAV stenosis, though recognizing that it still remains anecdotal.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.009827DOI Listing
July 2021

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 10 15;98(4):E581-E585. 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
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8518797PMC
October 2021

Treatment of degenerated surgical aortic valve: The importance of having a "lifetime strategy" in younger patients with severe aortic disease.

Catheter Cardiovasc Interv 2021 06;97(7):1489-1491

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

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http://dx.doi.org/10.1002/ccd.29766DOI Listing
June 2021

Prognostically relevant periprocedural myocardial injury and infarction associated with percutaneous coronary interventions: a Consensus Document of the ESC Working Group on Cellular Biology of the Heart and European Association of Percutaneous Cardiovascular Interventions (EAPCI).

Eur Heart J 2021 07;42(27):2630-2642

Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark.

A substantial number of chronic coronary syndrome (CCS) patients undergoing percutaneous coronary intervention (PCI) experience periprocedural myocardial injury or infarction. Accurate diagnosis of these PCI-related complications is required to guide further management given that their occurrence may be associated with increased risk of major adverse cardiac events (MACE). Due to lack of scientific data, the cut-off thresholds of post-PCI cardiac troponin (cTn) elevation used for defining periprocedural myocardial injury and infarction, have been selected based on expert consensus opinions, and their prognostic relevance remains unclear. In this Consensus Document from the ESC Working Group on Cellular Biology of the Heart and European Association of Percutaneous Cardiovascular Interventions (EAPCI), we recommend, whenever possible, the measurement of baseline (pre-PCI) cTn and post-PCI cTn values in all CCS patients undergoing PCI. We confirm the prognostic relevance of the post-PCI cTn elevation >5× 99th percentile URL threshold used to define type 4a myocardial infarction (MI). In the absence of periprocedural angiographic flow-limiting complications or electrocardiogram (ECG) and imaging evidence of new myocardial ischaemia, we propose the same post-PCI cTn cut-off threshold (>5× 99th percentile URL) be used to define prognostically relevant 'major' periprocedural myocardial injury. As both type 4a MI and major periprocedural myocardial injury are strong independent predictors of all-cause mortality at 1 year post-PCI, they may be used as quality metrics and surrogate endpoints for clinical trials. Further research is needed to evaluate treatment strategies for reducing the risk of major periprocedural myocardial injury, type 4a MI, and MACE in CCS patients undergoing PCI.
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http://dx.doi.org/10.1093/eurheartj/ehab271DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8282317PMC
July 2021

Joint EAPCI/ACVC expert consensus document on percutaneous ventricular assist devices.

Eur Heart J Acute Cardiovasc Care 2021 Jun;10(5):570-583

Department of Adult Intensive Care Unit, Royal Brompton and Harefield NHS Foundation Trust, Royal Brompton Hospital, Sydney Street, SW3 6NP London, UK.

There has been a significant increase in the use of short-term percutaneous ventricular assist devices (pVADs) as acute circulatory support in cardiogenic shock and to provide haemodynamic support during interventional procedures, including high-risk percutaneous coronary interventions. Although frequently considered together, pVADs differ in their haemodynamic effects, management, indications, insertion techniques, and monitoring requirements. This consensus document summarizes the views of an expert panel by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the Association for Acute Cardiovascular Care (ACVC) and appraises the value of short-term pVAD. It reviews the pathophysiological context and possible indications for pVAD in different clinical settings and provides guidance regarding the management of pVAD based on existing evidence and best current practice.
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http://dx.doi.org/10.1093/ehjacc/zuab015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8245145PMC
June 2021

Joint EAPCI/ACVC expert consensus document on percutaneous ventricular assist devices.

EuroIntervention 2021 Jul 20;17(4):e274-e286. Epub 2021 Jul 20.

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

There has been a significant increase in the use of short-term percutaneous ventricular assist devices (pVADs) as acute circulatory support in cardiogenic shock and to provide haemodynamic support during interventional procedures, including high-risk percutaneous coronary interventions. Although frequently considered together, pVADs differ in their haemodynamic effects, management, indications, insertion techniques, and monitoring requirements. This consensus document summarizes the views of an expert panel by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the Association for Acute Cardiovascular Care (ACVC) and appraises the value of short-term pVAD. It reviews the pathophysiological context and possible indications for pVAD in different clinical settings and provides guidance regarding the management of pVAD based on existing evidence and best current practice.
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http://dx.doi.org/10.4244/EIJY21M05_01DOI Listing
July 2021

Safety and efficacy of coronary sinus narrowing in chronic refractory angina: Insights from the RESOURCE study.

Int J Cardiol 2021 Aug 21;337:29-37. Epub 2021 May 21.

Interventional Cardiology Unit, GVM Care & Research Maria Cecilia Hospital, Cotignola, Italy.

Introduction: Refractory angina (RA) is considered the end-stage of coronary artery disease, and often has no interventional treatment options. Coronary sinus Reducer (CSR) is a recent addition to the therapeutic arsenal, but its efficacy has only been evaluated on small populations. The RESOURCE registry provides further insights into this therapy.

Methods: The RESOURCE is an observational, retrospective registry that includes 658 patients with RA from 20 centers in Europe, United Kingdom and Israel. Prespecified endpoints were the amelioration of anginal symptoms evaluated with the Canadian Cardiovascular Society (CCS) score, the rates of procedural success and complications, and MACEs as composite of all-cause mortality, acute coronary syndromes, and stroke.

Results: At a median follow-up of 502 days (IQR 225-1091) after CSR implantation, 39.7% of patients improved by ≥2 CCS classes (primary endpoint), and 76% by ≥1 class. Procedural success was achieved in 96.7% of attempts, with 3% of procedures aborted mostly for unsuitable coronary sinus anatomy. Any complication occurred in 5.7% of procedures, but never required bailout surgery nor resulted in intra- or periprocedural death or myocardial infarction. One patient developed periprocedural stroke after inadvertent carotid artery puncture. At the last available follow-up, overall mortality and MACE were 10.4% and 14.6% respectively. At one, three and five years, mortality rate at Kaplan-Meier analysis was 4%, 13.7%, and 23.4% respectively.

Conclusions: CSR implantation is safe and reduces angina in patients with refractory angina.
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http://dx.doi.org/10.1016/j.ijcard.2021.05.034DOI Listing
August 2021

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

JAMA Cardiol 2021 Aug;6(8):936-944

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
August 2021

Effect of Transcatheter Aortic Valve Replacement on Concomitant Mitral Regurgitation and Its Impact on Mortality.

JACC Cardiovasc Interv 2021 06 12;14(11):1181-1192. Epub 2021 May 12.

Servicio de Cardiología, Hospital Álvaro Cunqueiro, Vigo, Spain.

Objectives: The purpose of this study was to examine the impact of residual mitral regurgitation (MR) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR).

Background: MR is common in patients undergoing TAVR. Data on optimal management of patients with significant MR after TAVR are limited.

Methods: The registry consisted of 16 TAVR centers (n = 7,303). Outcomes of patients with ≥ moderate versus lesser grade MR after TAVR were compared.

Results: In 1,983 (27.2%) patients, baseline MR grade was ≥ moderate. MR regressed in 874 (44.1%) patients and persisted in 1,109 (55.9%) after TAVR. Four-year mortality was higher for those with MR persistence, but not for those with MR regression after TAVR, compared with nonsignificant baseline MR (43.8% vs. 35.1% vs. 32.4%; hazard ratio [HR]: 1.38; p = 0.008; HR: 1.02; p = 0.383, respectively). New York Heart Association functional class III to IV after TAVR was more common in those with MR persistence vs. regression (14.4% vs. 3.9%; p < 0.001). In a propensity score-matched cohort (91 patients' pairs), with significant residual MR after TAVR who did or did not undergo staged mitral intervention, staged intervention was associated with a better functional class through 1 year of follow-up (82.4% vs. 33.3% New York Heart Association functional class I or II; p < 0.001), and a numerically lower 4-year mortality, which was not statistically significant (64.6% vs. 37.5%; HR: 1.66; p = 0.097).

Conclusions: Risk stratification based on improvement in MR and symptoms after TAVR can identify patients at increased mortality risk after TAVR. These patients may benefit from a staged transcatheter mitral intervention, but this requires further proof from future studies. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter [AMTRAC] Valve Registry [AMTRAC]; NCT04031274).
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http://dx.doi.org/10.1016/j.jcin.2021.02.030DOI Listing
June 2021

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

Catheter Cardiovasc Interv 2021 05;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
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