Intra-Cardiac versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion with a Watchman FLX Device.

This study aimed to compare the peri-procedural success and complication rate within a large registry of intra-cardiac echocardiography (ICE)- vs. transesophageal echocardiography (TEE)-guided left atrial appendage occlusion (LAAO) procedures with a Watchmann FLX device. Data from 772 LAAO procedures, performed at 26 Italian centers, were reviewed. Technical success was considered as the final implant of a Watchmann FLX device in LAA; the absence of pericardial tamponade, peri-procedural stroke and/or systemic embolism, major bleeding and device embolization during the procedure was defined as a procedural success. One-year stroke and major bleeding rates were evaluated as outcome. ICE-guided LAA occlusion was performed in 149 patients, while TEE was used in 623 patients. Baseline characteristics were similar between the ICE and TEE groups. The technical success was 100% in both groups. Procedural success was also extremely high (98.5%), and was comparable between ICE (98.7%) and TEE (98.5%). ICE was associated with a slightly longer procedural time (73 ± 31 vs. 61.9 ± 36 min, p = 0.042) and shorter hospital stay (5.3 ± 4 vs. 5.8 ± 6 days, p = 0.028) compared to the TEE group. At one year, stroke and major bleeding rates did not differ between the ICE and TEE groups. A Watchmann FLX device showed high technical and procedural success rate, and ICE guidance does not appear inferior to TEE.

Periprocedural outcome in patients undergoing left atrial appendage occlusion with the Watchman FLX device: The ITALIAN-FLX registry.

Introduction: The Watchman FLX is a novel device for transcatheter left atrial appendage occlusion (LAAO) specifically designed to improve procedural performance in more complex anatomies with a better safety profile. Recently, small prospective non-randomized studies have shown good procedural success and safety compared with previous experiences. Results from large multicenter registries are needed to confirm the safety and efficacy of the Watchman FLX device in a real-world setting. Methods: Italian FLX registry is a retrospective, non-randomized, multicentric study across 25 investigational centers in Italy including consecutive patients undergoing LAAO with the Watchman FLX between March 2019 and September 2021 (N = 772). The primary efficacy outcome was the technical success of the LAAO procedure (peri-device flow ≤ 5 mm) as assessed by intra-procedural imaging. The peri-procedural safety outcome was defined as the occurrence of one of the following events within 7 days after the procedure or by hospital discharge: death, stroke, transient ischemic attack, major extracranial bleeding (BARC type 3 or 5), pericardial effusion with tamponade or device embolization. Results: A total of 772 patients were enrolled. The mean age was 76 ± 8 with a mean CHA2DS2-VASc score of 4.1 ± 1.4 and a mean HAS-BLED score of 3.7 ± 1.1. Technical success was achieved in 772 (100%) patients with the first device implanted in 760 (98.4%) patients. A peri-procedural safety outcome event occurred in 21 patients (2.7%) with major extracranial bleeding being the most common (1.7%). No device embolization occurred. At discharge 459 patients (59.4%) were treated with dual antiplatelet therapy (DAPT). Conclusions: The Italian FLX registry represents the largest multicenter retrospective real-world study reporting periprocedural outcome of LAAO with the Watchman FLX device, resulting in a procedural success rate of 100% and a low incidence of peri-procedural major adverse events (2.7%).

Impact of in-Hospital Left Ventricular Ejection Fraction Recovery on Long-Term Outcomes in Patients Who Underwent Impella Support for HR PCI or Cardiogenic Shock: A Sub-Analysis from the IMP-IT Registry.

(1) Background: Percutaneous left ventricle assist devices (pLVADs) demonstrated an improvement in mid-term clinical outcomes in selected patients with severely depressed left ventricular ejection fraction (LVEF) undergoing percutaneous coronary interventions. However, the prognostic impact of in-hospital LVEF recovery is unclear. Accordingly, the present sub-analysis aims to evaluate the impact of LVEF recovery in both cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR PCI) supported with pLVADs in the IMP-IT registry. (2) Methods: A total of 279 patients (116 patients in CS and 163 patients in HR PCI) treated with Impella 2.5 or CP in the IMP-IT registry were included in this analysis, after excluding those who died while in the hospital or with missing data on LVEF recovery. The primary study objective was a composite of all-cause death, rehospitalisation for heart failure, left ventricle assist device (LVAD) implantation, or heart transplantation (HT), overall referred to as the major adverse cardiac events (MACE) at 1 year. The study aimed to evaluate the impact of in-hospital LVEF recovery on the primary study objective in patients treated with Impella for HR PCI and CS, respectively. (3) Results: The mean in-hospital change in LVEF was 10 ± 1% (p < 0.001) in the CS cohort and 3 ± 7% (p < 0.001) in the HR PCI group, achieved by 44% and 40% of patients, respectively. In the CS group, patients with less than 10% in-hospital LVEF recovery experienced higher rates of MACE at 1 year of follow-up (FU) (51% vs. 21%, HR 3.8, CI 1.7-8.4, p < 0.01). After multivariate analysis, LVEF recovery was the main independent protective factor for MACE at FU (HR 0.23, CI 0.08-0.64, p = 0.02). In the HR PCI group, LVEF recovery (>3%) was not associated with lower MACE at multivariable analysis (HR 0.73, CI 0.31-1.72, p = 0.17). Conversely, the completeness of revascularisation was found to be a protective factor for MACE (HR 0.11, CI 0.02-0.62, p = 0.02) (4) Conclusions: Significant LVEF recovery was associated with improved outcomes in CS patients treated with PCI during mechanical circulatory support with Impella, whereas complete revascularisation showed a significant clinical relevance in HR PCI.

Safety of metformin continuation in diabetic patients undergoing invasive coronary angiography: the NO-STOP single arm trial.

BACKGROUND: Despite paucity of data, it is common practice to discontinue metformin before invasive coronary angiography due to an alleged risk of Metformin-Associated Lactic Acidosis (M-ALA). We aimed at assessing the safety of metformin continuation in diabetic patients undergoing coronary angiography in terms of significant increase in lactate levels. METHODS: In this open-label, prospective, multicentre, single-arm trial, all diabetic patients undergoing coronary angiography with or without percutaneous coronary intervention at 3 European centers were screened for enrolment. The primary endpoint was the increase in lactate levels from preprocedural levels at 72-h after the procedure. Secondary endpoints included contrast associated-acute kidney injury (CA-AKI), M-ALA, and all-cause mortality. RESULTS: 142 diabetic patients on metformin therapy were included. Median preprocedural lactate level was 1.8 mmol/l [interquartile range (IQR) 1.3-2.3]. Lactate levels at 72 h after coronary angiography were 1.7 mmol/l (IQR 1.3-2.3), with no significant differences as compared to preprocedural levels (p = 0.91; median difference = 0; IQR - 0.5 to 0.4 mmol/l). One patient had 72-h levels ≥ 5 mmol/l (5.3 mmol/l), but no cases of M-ALA were reported. CA-AKI occurred in 9 patients (6.1%) and median serum creatinine and estimated glomerular filtration rate remained similar throughout the periprocedural period. At a median follow-up of 90 days (43-150), no patients required hemodialysis and 2 patients died due to non-cardiac causes. CONCLUSIONS: In diabetic patients undergoing invasive coronary angiography, metformin continuation throughout the periprocedural period does not increase lactate levels and was not associated with any decline in renal function. TRIAL REGISTRATION: The study was registered at Clinicaltrials.gov (NCT04766008).

Permanent pacemaker implantation and left bundle branch block with self-expanding valves - a SCOPE 2 subanalysis.

BACKGROUND: No detailed data on left bundle branch block (LBBB) and permanent pacemaker implantation (PPI) exist from randomised clinical trials comparing the ACURATE neo and CoreValve Evolut devices. AIMS: Our aim was to assess the incidence and impact of new LBBB and PPI with self-expanding prostheses from a powered randomised comparison. METHODS: From the SCOPE 2 trial, 648 patients with no previous pacemaker were analysed for PPI at 30 days, and 426 patients without previous LBBB were adopted for analysis of LBBB at 30 days.  Results: At 30 days, 16.5% of patients required PPI; rates were higher in CoreValve Evolut compared to ACURATE neo recipients (21.0% vs 12.3%; p=0.004). Previous right bundle branch block (odds ratio [OR] 6.11, 95% confidence interval [CI]: 3.19-11.73; p<0.001) was associated with an increased risk of PPI at 30 days, whereas the use of the ACURATE neo (OR 0.50, 95% CI: 0.31-0.81; p=0.005) was associated with a decreased risk. One-year mortality was similar in patients with and without new PPI. A total of 9.4% of patients developed persistent LBBB at 30 days, with higher incidences in CoreValve Evolut recipients (13.4% vs 5.5%; p=0.007). New LBBB at 30 days was associated with lower ejection fraction at 1 year (65.7%±11.0 vs 69.1%±7.6; p=0.041). CONCLUSIONS: New LBBB and PPI rates were lower in ACURATE neo compared to CoreValve Evolut recipients. The ACURATE neo valve was associated with a lower risk of PPI at 30 days. No effect on 1-year mortality was determined for PPI at 30 days, while LBBB at 30 days was associated with reduced ejection fraction at 1 year.

Simultaneous Radial and Ipsilateral Ulnar Artery Compression versus Isolated Radial Artery Compression after Conventional Radial Access for Coronary Angiography and/or Intervention: A Systematic Review and Meta-Analysis.

Background: Simultaneous ulnar and radial artery compression (SURC) has emerged as a strategy to increase radial artery flow and mitigate radial artery occlusion (RAO) while achieving adequate hemostasis after transradial access (TRA), though its technical adoption has been limited worldwide. Methods: A systematic search of studies comparing SURC versus isolated radial artery compression after TRA for coronary angiography and/or intervention was performed. Data were pooled by meta-analysis using random-effects models. Odds ratios (OR) with relative 95% confidence intervals (CI) and standardized mean difference were used as measures of effect estimates. The primary endpoint was the occurrence of overall RAO. Results: A total of 6 studies and 6793 patients were included. SURC method as compared to isolated radial artery compression was associated with a lower risk of RAO both overall (OR 0.29; 95% CI, 0.13−0.61, p < 0.001; number needed to treat to benefit [NNTB] =38) and in-hospital (OR 0.28; 95% CI: 0.10 to 0.75; p = 0.01, NNTB = 36), with a reduced risk of unsuccessful patent hemostasis (OR: 0.13; 95% CI: 0.02 to 0.85; p = 0.03, NNT = 5) and upper extremity pain (OR: 0.48; 95% CI: 0.24 to 0.95; p = 0.04, NNTB = 124). No significant difference was observed in hemostasis time and in the risk of hematoma. Conclusion: Compared to isolated radial artery compression, SURC is associated with lower risk of RAO, unsuccessful patent hemostasis, and reported upper limb pain, without any trade-off in safety outcomes. With further development of dedicated dual compression devices, the proposed technique should be freed from usage constraints.

Long term follow-up after balloon expandable covered stents implantation for management of transcatheter aortic valve replacement related vascular access complications.

OBJECTIVES: To report the experience of a high-volume center with balloon-expandable (BE) stents implantation to manage vascular complications after transcatheter aortic valve replacement (TAVR). BACKGROUND: Despite increased operator experience and better devices, vascular complications after TAVR are still a major issue and covered stent implantation is often required. METHODS: We retrospectively collected baseline and procedural data about 78 consecutive patients who underwent BE stent implantation to manage a vascular complication after transfemoral TAVR. Primary endpoints were technical success, incidence of new-onset claudication and need for vascular interventions during long-term follow-up. Secondary endpoints included length of hospitalization, in-hospital and 30-day mortality, and major postoperative complications. RESULTS: BE stents implantation to manage vascular complications after TAVR was successfully performed in 96.2% of the cases, with bailout surgery required in two cases. One patient suffered in-hospital death. Predischarge Doppler Ultrasound revealed no cases of in-stent occlusion or fracture. At a median follow-up of 429 days (interquartile range, 89-994 days), no cases of symptomatic leg ischemia were reported and only one patient experienced new-onset claudication. CONCLUSIONS: Our experience showed good periprocedural and long-term results of BE covered stent implantation to manage vascular complication after TAVR. Their great radial outward force may guarantee effective hemostasis without necessarily being associated with stent deformation/fracture resulting in restenosis or further interventions. More research is needed to define the role of BE covered stents in this setting.

Left atrial appendage closure with the II generation Ultraseal device: An international registry. The LIGATE study.

OBJECTIVES: To assess feasibility and safety of second-generation left atrial appendage closure (LAAC) Ultraseal device in patients with nonvalvular atrial fibrillation (NVAF). BACKGROUND: LAAC with first-generation Ultraseal device (Cardia, Eagan, Minnesota) has been shown to be a feasible therapeutic option in patients with NVAF. However, there is a paucity of data regarding the novel second-generation Ultraseal device. METHODS: All patients with NVAF undergoing second-generation Ultraseal device implantation between February 2018 and September 2020 were included in a multicenter international registry. Periprocedural and post-discharge events were collected through 6-month follow-up. Co-primary efficacy endpoints were device success and technical success while primary safety endpoint was in-hospital major adverse event (MAE) occurrence. RESULTS: A total of 52 patients were included: mean age 75 ± 8, 30.8% women, mean HAS-BLED 3 ± 1. The device was successfully implanted in all patients. Technical success was achieved in 50 patients (96.1%). In-hospital MAEs occurred in three patients (5.8%). The incidence of 6-month all-cause death and major bleeding was 11.6% and 2.1%, respectively. No strokes, transient ischemic attacks, systemic embolisms, or device embolization were reported after discharge. CONCLUSIONS: Second-generation Ultraseal device implantation was associated with high success rates and a low incidence of peri-procedural complications. Larger studies with longer follow-up are warranted to further evaluate the safety and the efficacy of this device, especially at long-term follow-up.

Edge-to-edge percutaneous mitral repair for functional ischaemic and non-ischaemic mitral regurgitation: a systematic review and meta-analysis.

AIM: Randomized controlled trials comparing the use of the MitraClip device in addition to guideline directed medical therapy (GDMT) to GDMT alone in patients with secondary mitral regurgitation (MR) have shown conflicting results. However, if these differences could be due to the underlying MR aetiology is still unknown. Therefore, we aimed to evaluate if the effects of percutaneous edge-to-edge repair with MitraClip implantation could differ in patients with ischaemic (I-MR) and non-ischaemic mitral regurgitation (NI-MR). METHODS AND RESULTS: PubMed, Embase, BioMed Central, and the Cochrane Central Register of Controlled Trials were searched for all studies including patients with secondary MR treated with the MitraClip device. Data were pooled using a random-effects model. Primary endpoint was the composite of all-cause death and heart failure-related hospitalization. Secondary endpoints were the single components of the primary endpoint, New York Heart Association functional Classes III and IV, and mitral valve re-intervention. Seven studies enrolling 2501 patients were included. Patients with I-MR compared with patients with NI-MR had a similar risk of the primary endpoint (odds ratio: 1.17; 95% confidence interval: 0.93 to 1.46; I2 : 0%). The risk of all-cause death was increased in patients with I-MR (odds ratio: 1.31; 95% confidence interval: 1.07 to 1.62; I2 : 0%), while no differences were observed between the two groups in terms of the other secondary endpoints. CONCLUSIONS: The risk of mortality after MitraClip implantation is lower in patients with NI-MR than in those with I-MR. No absolute differences in the risk of heart failure related hospitalization were observed between groups.

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

BACKGROUND: The Academic Research Consortium - High Bleeding Risk (ARC-HBR) initiative defined conditions associated with percutaneous coronary intervention (PCI)-related bleeding. AIMS: We sought to further explore these HBR conditions in the setting of transcatheter aortic valve replacement (TAVR). METHODS: Patients from the SCOPE 2 trial were stratified by their bleeding risk status based on the ARC-HBR definitions. Baseline and procedural characteristics, as well as key clinical outcomes including Bleeding Academic Research Consortium (BARC) 3-5 bleeding, were compared in ARC-HBR positive (HBR+) and ARC-HBR negative (HBR-) patients. RESULTS: Of 787 patients randomised in SCOPE 2 and included in this study, 633 were HBR+ (80.4%). Compared with HBR- patients, those HBR+ were older and more frequently presented with diabetes, a history of coronary artery disease, atrial fibrillation, prior cerebrovascular accident, and a Society of Thoracic Surgeons predicted risk of 30-day mortality (STS-PROM) (4.9±2.9% vs 3.3%±2.1%; p<0.0001). In addition, HBR+ patients were more frequently on oral anticoagulation therapy. At 1 year, HBR+ patients had higher rates of all-cause death (12.4% vs 4.3%, respectively, risk difference 8.09%; 95% confidence interval [CI]: 3.76-12.41; p=0.0002); the rates of BARC 3-5 type bleeding were relatively high but not statistically different compared with HBR- patients (7.7% vs 6.1%, risk difference 1.67%; 95% CI: -2.72 to 6.06; p=0.46). Subgroup analyses for bleeding events showed no significant interaction in terms of STS-PROM score, age, or medications. CONCLUSIONS: The ARC-HBR criteria failed to isolate a subgroup of patients at higher bleeding risk in TAVR patients from a randomised trial. These findings have potential implications, especially for the selection of post-TAVR antithrombotic regimens based on individual bleeding-risk profiles. Specific HBR criteria should be defined for TAVR patients.

Left Anterior Descending Coronary Artery Occlusion After Balloon Aortic Valvuloplasty.

We report the case of a bridge balloon aortic valvuloplasty (BAV) complicated by non-ST elevation myocardial infarction in a 75-year-old woman with severe aortic stenosis. Coronary angiography showed left anterior descending occlusion, while no lesions were apparent at pre-operative angiogram. The case highlights a potential severe complication of BAV and its management.

Patent foramen ovale occlusion with the Cocoon PFO Occluder. The PROS-IT collaborative project.

Background: The Cocoon patent foramen ovale (PFO) Occluder is a new generation nitinol alloy double-disk device coated with nanoplatinum, likely useful in patients with nickel hypersensitivity. Early results and mid-term outcomes of this device in percutaneous PFO closure are missing. Aims: To assess the preliminary efficacy and safety profile of PFO closure with Cocoon device in an Italian multi-center registry. Methods: This is a prospective registry of 189 consecutive adult patients treated with the Cocoon PFO Occluder at 15 Italian centers from May 2017 till May 2020. Patients were followed up for 2 years. Results: Closure of the PFO with Cocoon Occluder was carried out successfully in all patients, with complete closure without residual shunt in 94.7% of the patients and minimal shunt in 5.3%. Except from a case of paroxysmal supraventricular tachycardia and a major vascular bleeding, no procedural and in-hospital device-related complications occurred. No patient developed cardiac erosions, allergic reactions to nickel, or any other major complications during the follow-up. During the follow-up period, 2 cases of new-onset atrial fibrillation occurred within thirty-day. Conclusions: Percutaneous closure of PFO with Cocoon Occluder provided satisfactory procedural and mid-term clinical follow-up results in a real-world registry.

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

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.

[Feasibility and safety of same-day discharge after elective transcatheter interventions: experience of a high-volume center]. / Fattibilità e sicurezza della dimissione in giornata per procedure elettive di cardiologia interventistica in un centro ad alto volume.

BACKGROUND: Safety of same-day discharge (SSD) after percutaneous coronary interventions (PCI) has been demonstrated in several studies. However, SDD is rarely adopted in Italy, with a potential waste of resources and decrease of patient satisfaction. METHODS: In 2019 we implemented a strategy of SDD for all elective coronary procedures admitted to our Radial Unit. Patients were excluded from SDD in case of contraindications for radial access, known contrast allergy, known left main disease based on previous angiogram or coronary computed tomography scan, chronic total occlusions considered as target of revascularization. We assessed the feasibility and safety of this approach in consecutive patients treated at Humanitas Research Center. RESULTS: Out of 366 patients who were admitted electively to our Radial Unit, 152 (41.5%) underwent only diagnostic coronary angiography, while 214 underwent PCI. As expected, radial access was used in the vast majority of cases (361; 98.6%). Patients were mostly discharged in the same day (268; 73%), both after diagnostic (96.7%) and interventional (56.5%) procedures. Patients that were hospitalized at least for one night were older, had a higher cardiovascular risk profile and had a more complex coronary anatomy (left main or proximal left anterior descending artery disease, bifurcations, total occlusions). There were no significant differences between patients discharged and those who were admitted overnight with regards to 7- and 30-day hospital readmission. CONCLUSIONS: SSD is safe and feasible in the majority of patients after elective coronary procedures (both diagnostic angiography and PCI), and is not associated with increased hospital readmission at 7 and 30 days. On the basis of the current study, a wider SDD program will be implemented in 2020.

Timing of Impella implantation and outcomes in cardiogenic shock or high-risk percutaneous coronary revascularization.

OBJECTIVE: To evaluate the role of the microaxial percutaneous mechanical circulatory support device (Impella® pump) implantation pre-percutaneous coronary intervention (PCI) versus during/after PCI in cardiogenic shock (CS) and high-risk PCI populations. BACKGROUND: A better understanding of the safety and effectiveness of the Impella and the role of timing of this support initiation in specific clinical settings is of utmost clinical relevance. METHODS: A total of 365 patients treated with Impella 2.5/CP in the 17 centers of the IMP-IT Registry were included. Through propensity-score weighting (PSW) analysis, 1-year clinical outcomes were assessed separately in CS and HR-PCI patients, stratified by timing of Impella support. RESULTS: Pre-procedural insertion was associated with an improvement in 1-year survival in patients with CS due to acute myocardial infarction (AMI) treated with PCI (p = .04 before PSW, p = .009 after PSW) and HR-PCI (p < .01 both before and after PSW). Among patients undergoing HR-PCI, early Impella support was also associated with a lower rate of the composite of mortality, re-hospitalization for heart failure, and need for left-ventricular assist device/heart transplantation at 1-year (p = .04 before PSW, p = .01 after PSW). Furthermore, Impella use during/after PCI was associated with an increased in-hospital life-threatening and severe bleeding among patients with AMI-CS receiving PCI (7 vs. 16%, p = .1) and HR-PCI (1 vs. 9%, p = .02). CONCLUSIONS: Our findings suggested a survival benefit and reduced rates of major bleeding when a pre-PCI Impella implantation instead of during-after procedure was used in the setting of HR-PCI and AMI-CS.

[Percutaneous mitral valve repair in acute mitral regurgitation]. / Plastica mitralica transcatetere per il trattamento dell'insufficienza mitralica acuta.

Acute mitral regurgitation is a life-threatening pathology. Nowadays, percutaneous mitral valve repair with the MitraClip device offers, in selected patients, a safe and effective therapeutic alternative to open surgery. Hereby, we report the case of an 82-year-old woman with lateral ST-elevation myocardial infarction determining severe acute mitral regurgitation, who was treated with an urgent MitraClip procedure. Moreover, we discuss echocardiographic assessment of acute mitral regurgitation and we review available literature and possible management of this complex scenario.