Mitral valve transcatheter edge-to-edge repair with PASCAL Vs MitraClip: A aystematic teview and meta-analysis.

BACKGROUND: Transcatheter edge-to-edge repair (TEER) using the MitraClip (Abbott Vascular) system has emerged as a standard treatment for patients with symptomatic severe secondary or inoperable primary mitral regurgitation (MR). The relatively recent approval of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences) has expanded the options of TEER devices. However, evidence comparing PASCAL with MitraClip systems is still limited. METHODS: We conducted a systematic literature research and meta-analysis in PubMed, Medline, and EMBASE databases for studies comparing PASCAL and MitraClip systems. RESULTS: Four observational studies and 1 randomized controlled trial, involving 1315 patients total, were eligible for inclusion. All patients exhibited symptomatic (NYHA II-IV) MR grades 3+ or 4+. Baseline characteristics were comparable across all included studies. The clinical outcomes were assessed according to the Mitral Valve Academic Research Consortium consensus. The procedural success rates for the 2 devices were comparable in terms of achieving post-procedural MR grades of less than or equal to 2+ and less than or equal to 1+. Furthermore, most patients improved their clinical status, with no significant differences between patients treated with PASCAL and those treated with MitraClip. In terms of safety, both procedures exhibited low overall mortality rates and occurrence of major adverse events (MAE), without significant difference between the 2 devices. These findings remained consistent in both short- and long-term follow-up assessments. CONCLUSIONS: Our study revealed similar effectiveness and safety profiles between the PASCAL and MitraClip devices in patients experiencing significant symptomatic MR.

SUOH 03 Guidewire for the Management of Coronary Artery Dissection: Insights from a Multicenter Registry.

Background: In the setting of coronary artery dissection, both spontaneous and iatrogenic, fixing the intimal tear, usually with stent implantation, can be extremely challenging if the distal wire position has been lost. Common complications are mainly related to the inadvertent subintimal tracking of the guidewire while attempting to gain the distal true lumen. Aims: To report the registry results of using the SUOH 0.3 guidewire for managing coronary artery dissection in a real-world multicenter setting. Methods: The study population in this retrospective, multicenter, international registry included 75 consecutive patients who underwent PCI and required an antegrade wiring of a dissected coronary artery. Results: Successful use of SUOH 0.3 was achieved in 69 (92%) patients. The use of a microcatheter was associated with a significantly higher rate of TIMI 3 flow at the end of the procedure (no microcatheter: n = 17, 81%; microcatheter: n = 52, 96.3%; p = 0.017). The first recanalization attempt was made with the SUOH 03 guidewire in 48 (64%) cases, and it was successful in 42 (87%). The overall PCI success rate was reported in 72 (96%) patients, with no significant differences among patients with different origins, mechanisms, and locations of dissection. Conclusions: In this setting, the SUOH 0.3 guidewire provides high procedural success without additional complex techniques.

ImpaCt of an Optimal Implantation Strategy on Absorb Long-Term Outcomes: The CIAO Registry.

AIM: To compare the long-term outcomes of patients implanted with Absorb bioresorbable scaffold (BRS) with optimal versus suboptimal technique. METHODS AND RESULTS: All patients who received an Absorb between March 2012 and January 2016 were selected from 19 Italian centers databases to assess the impact of an optimal implantation technique (CIAO criteria) on long-term device-oriented composite end-point (DOCE) - including cardiac death (CD), target-vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) - on its single components and on scaffold thrombosis (ScT). CIAO criteria consist of predilation (balloon/vessel ratio 1:1), correct sizing (BRS/proximal reference vessel diameter -RVD- ratio 0.8-1.2) and high-pressure postdilation with non-compliant (NC) balloon (≥20 atm for balloon/BRS ratio 1:1 or ≥16 atm for a 0.25-0.5 mm oversized balloon). Among the 1.434 patients analyzed, 464 (32.4%) fulfilled all CIAO criteria for every BRS implanted (CIAO 3 group), while 970 (67.6%) did not in at least one of the received BRS (CIAO 0-1-2 group). At 31.0 (interquartile range -IQR- 24.8-38.5) months follow-up, CIAO criteria did not impact on DOCE (8.2% vs. 8.0%, p = 0.92), ID-TLR (6.9% vs. 7.1%, p = 0.72) or ScT (1.9% vs. 1.8%, p = 0.80) in the overall population. At multivariate analysis overall BRS length (p = 0.001), severely calcified lesions (p = 0.03) and absence of CIAO criteria (CIAO 0, p = 0.005) were independent predictors of DOCE in long-term follow-up. CONCLUSION: Our data suggest that strict application of an optimal Absorb implantation technique doesn't improve long-term DOCE or ScT but may mitigate the worse outcome of patients with calcific lesions.

IntravaScular Lithotripsy for the Management of UndILatable Coronary StEnt: The SMILE Registry.

BACKGROUND: Intravascular lithotripsy (IVL) showed to be effective in dilating heavily calcified de novo coronary lesions but little is known about its performance in under-expanded stents management. Aim of this study was to assess the feasibility, effectiveness and safety of IVL for the treatment of stent underexpansion refractory to balloon dilatation. METHODS: A multicentre, retrospective cohort analysis was performed in patients undergoing IVL to treat under-expanded stents following non-compliant balloon expansion failure. Primary endpoint was successful IVL dilatation defined as IVL balloon delivery and application at the target site followed by an increase of at least 1 mm2 in minimal stent cross-sectional area (MSA) on intracoronary imaging or an increase of at least 20% in minimal stent diameter (MSD) by quantitative coronary analysis (QCA). RESULTS: Thirty-nine under-expanded stents (34 patients) were included. Two cases (5.1%) of multiple stent layers and one (2.5%) acutely under-expanded stent were treated. The median IVL balloon diameter was 3.1 mm (IQR: 2.5-3.5 mm) while the number of pulses emitted was 56.7 (IQR: 30-80). IVL was successful in 34 cases (87.1%), with significant improvement in MSD (post: 3.23 mm [IQR: 3-3.5 mm] vs. pre: 0.81 mm [IQR: 0.35-1.2], p < 0.00001) and MSA (post: 7.61mm2 [IQR: 6.43-7.79mm2] vs. pre: 3.35 [IQR: 2.8-4 mm2], p < 0.00001). Non-fatal peri-procedural ST-elevation myocardial infarction occurred in one case (2.5%) due to IVL balloon rupture. No cardiac death, target lesion revascularization and stent thrombosis occurred in-hospital and at 30-day follow-up. CONCLUSIONS: Bailout IVL was feasible, efficacious and safe to improve refractory stent under-expansion.

No-Reflow Complicating Chronic Total Occlusion Coronary Revascularization.

OBJECTIVES: To assess the incidence of no-reflow in patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI), analyze possible causes and differential diagnoses, and identify useful management approaches. METHODS: In this multicenter observational study, all CTO-PCIs performed between January 2018 and April 2019 were reviewed to collect no-reflow complications, defined as Thrombolysis in Myocardial Infarction (TIMI) flow ≤1 in a patent epicardial artery. Patient clinical, anatomical, and procedural characteristics were analyzed. RESULTS: Out of 461 PCIs, two (0.43%) were complicated by no-reflow. In 1 case, PCI was performed on a long segment of the right coronary artery, after use of a dissection-re-entry technique by knuckle wiring. In the second patient, no-reflow developed after proximal left anterior descending coronary artery stenting, with a short subintimal tracking. Intravascular ultrasound was used to exclude complications in the epicardial vessel in both cases. Distal embolization seems the most plausible cause, and intracoronary adenosine effectively improved flow. Both patients had a type 4a myocardial infarction, asymptomatic in the first case, and associated with chest pain, electrocardiographic changes, and new regional wall-motion abnormality at echocardiography in the second case. CONCLUSIONS: No-reflow in CTO recanalization is rare, but associated with a high risk of periprocedural myocardial infarction, with incomplete protection from ischemia offered by the pre-existing collateral network.

Coronary artery aneurysms, insights from the international coronary artery aneurysm registry (CAAR).

BACKGROUND: Coronary Aneurysms are a focal dilatation of an artery segment >1.5-fold the normal size of adjacent segments. Although some series have suggested a prevalence of 0.3-12%, data are lacking. In addition, they are not mentioned in practice guidelines. Our aim was investigate its prevalence, management and long-term outcomes. METHODS AND RESULTS: The coronary artery aneurysm registry (CAAR) involved 32 hospitals across 9 countries in America and Europe. We reviewed 436,467 consecutive angiograms performed over the period 2004-2016. Finally, 1565 patients were recruited. Aneurysm global prevalence was 0.35%. Most patients were male (78.5%) with a mean age of 65 years and frequent cardiovascular risk factors. The main indication for angiogram was an acute coronary syndrome, 966 cases. The number of aneurisms was ≤2 per patient in 95.8% of the cases, mostly saccular, most frequently found in the left anterior descending and with numbers proportional with coronary stenosis. Aortopathies were related with more aneurysms too. Most patients received any revascularization procedure (69%), commonly percutaneous (53%). After a median follow-up of 37.2 months, 485 suffered a combined event (MACE) and 240 died. Without major differences comparing CABG vs PCI, MACE and death were more frequent in patients who received bare metal stents. CONCLUSIONS: Coronary artery aneurysms are not uncommon. Usually, they are associated with coronary stenosis and high cardiovascular risk. Antiplatelet therapy seems reasonable and a percutaneous approach is safe and effective.

XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial.

BACKGROUND: Thin strut 3rd generation drug eluting stents offer the potential advantage over the previous generation of better technical performance and reduced neointimal proliferation parameters, which are linked to mid and late term device failure. AIM: To evaluate the performance of the Xlimus sirolimus-eluting stent (SES) against the Synergy everolimus-eluting stent (EES) in terms of device reendothelialization in patients undergoing PCI for coronary artery disease (CAD). METHODS: XLIMIT is a multicenter randomized controlled trial targeting 180 patients requiring percutaneous coronary interventions (PCI). Patients will be treated with Xlimus SES or Synergy EES implantation and randomization will be performed in a 2:1 ratio. The primary endpoint will be the reendothelialization grade of the Xlimus stent in terms of strut coverage and neointimal hyperplasia volume as compared to Synergy. Secondary endpoints will be represented by clinical and procedural outcomes. The first patient was enrolled on February 2019. CONCLUSIONS: A clearer understanding of the endothelialization process of new generation DES could significantly impact the treatment with dual antiplatelet therapy in the future. Moreover, although not powered for clinical end-points, the XLIMIT trial will provide randomized data in a population with minimal exclusion criteria. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03745053. Registered on November 19, 2018.

[Epidemiology of stroke and cerebral protection in patients undergoing transcatheter aortic valve replacement]. / Epidemiologia e prevenzione dell'ictus in pazienti sottoposti ad impianto transcatetere di valvola aortica.

The introduction into clinical practice of transcatheter aortic valve implantation (TAVI) has led to a significant change in the therapeutic paradigm for patients with valvular aortic stenosis. However, in parallel with the benefits obtained in prognosis and quality of life, an inherent risk of major cerebral thromboembolic events has been observed. In different studies this risk has been estimated between 2% and 6%. In order to reduce the incidence of cerebrovascular accidents during TAVI, several brain protection systems have been developed but, to date, none has obtained sufficient clinical evidence to be implemented on a large scale, and they are therefore used only in selected cases. Furthermore, periprocedural drug therapy and follow-up are still the subject of extensive discussion in the scientific community. This paper reviews the topic of stroke prevention in patients undergoing TAVI for both the periprocedural and postprocedural aspects.

APpropriAteness of percutaneous Coronary interventions in patients with ischaemic HEart disease in Italy: the APACHE pilot study.

OBJECTIVES: To first explore in Italy appropriateness of indication, adherence to guideline recommendations and mode of selection for coronary revascularisation. DESIGN: Retrospective, pilot study. SETTING: 22 percutaneous coronary intervention (PCI)-performing hospitals (20 patients per site), 13 (59%) with on-site cardiac surgery. PARTICIPANTS: 440 patients who received PCI for stable coronary artery disease (CAD) or non-ST elevation acute coronary syndrome were independently selected in a 4:1 ratio with half diabetics. PRIMARY AND SECONDARY OUTCOME MEASURES: Proportion of patients who received appropriate PCI using validated appropriate use scores (ie, AUS≥7). Also, in patients with stable CAD, we examined adherence to the following European Society of Cardiology recommendations: (A) per cent of patients with complex coronary anatomy treated after heart team discussion; (B) per cent of fractional flow reserve-guided PCI for borderline stenoses in patients without documented ischaemia; (C) per cent of patients receiving guideline-directed medical therapy at the time of PCI as well as use of provocative test of ischaemia according to pretest probability (PTP) of CAD. RESULTS: Of the 401 mappable PCIs (91%), 38.7% (95% CI 33.9 to 43.6) were classified as appropriate, 47.6% (95% CI 42.7 to 52.6) as uncertain and 13.7% (95% CI 10.5% to 17.5%) as inappropriate. Median PTP in patients with stable CAD without known coronary anatomy was 69% (78% intermediate PTP, 22% high PTP). Ischaemia testing use was similar (p=0.71) in patients with intermediate (n=140, 63%) and with high PTP (n=40, 66%). In patients with stable CAD (n=352) guideline adherence to the three recommendations explored was: (A) 11%; (B) 25%; (C) 23%. AUS was higher in patients evaluated by the heart team as compared with patients who were not (7 (6.8) vs 5 (4.7); p=0.001). CONCLUSIONS: Use of heart team approaches and adherence to guideline recommendations on coronary revascularisation in a real-world setting is limited. This pilot study documents the feasibility of measuring appropriateness and guideline adherence in clinical practice and identifies substantial opportunities for quality improvement. TRIAL REGISTRATION NUMBER: NCT02748603.

Unprotected left main revascularization: Percutaneous coronary intervention versus coronary artery bypass. An updated systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: The optimal treatment of unprotected left main (UPLM) with either PCI or CABG remains uncertain. AIM: The purpose of this study was to determine the comparative safety and efficacy of PCI versus CABG in patients with UPLM disease. METHODS: Search of BioMedCentral, CENTRAL, mRCT, PubMed, major cardiological congresses proceedings and references cross-check (updated November 2016). Outcomes were the rate of MACE [all cause death, MI, stroke], the rates of the individual components of MACE and the rate of target vessel revascularisation (TVR). RESULTS: We identified 6 Randomised Controlled Trials totalling 4717 patients allocated to PCI or CABG. At 1 year follow up, PCI and CABG were substantially equivalent with respect to the rates of MACE [PCI 8.5% vs CABG 8.9%, OR 1.02,(0.76-1.36), p = 0.9], death [PCI 5.4% vs CABG 6.6%, OR 0.81,(0.63-1.03),p = 0.08] and MI [PCI 3.4% vs CABG 4.3%, OR 0.80(0.59-1.07), p = 0.14]. Notably, PCI was associated with a significantly lower rate of stroke [PCI 0.6% vs CABG 1.8%, OR 0.36,(0.17-0.79), p = 0.01] and with a significantly higher rate of TVR [PCI 8.7% vs CABG 4.5%, OR 2.00(1.46-2.75), p<0.01]. At a median follow up of 5years, the rates of MACE were similar between the two strategies: PCI 14.6% vs CABG 13.8%, OR 1.02(0.76-1.38), p = 0.89. Likewise, the rates of death [PCI 8% and CABG 7.7%, OR 1(0.77-1.31), P = 0.9], MI [PCI 6.1% vs CABG 5%, OR 1.41(0.85-2.34), P = 0.19, I2 59%], and stroke [PCI 2% vs CABG 2.2%, OR 0.85(0.42-1.81), p = 0.65,] were similar while PCI was associated with a significantly higher rate of TVR [14.5% vs CABG 8.9%, OR 1.73(1.41-2.13), p<0.01]. CONCLUSION: In patients with UPLM disease, PCI and CABG are associated with similar rates of MACE and mortality at 1 year as well as after 5 years. Differences can be detected for individual end points at both short and long term FU.

Rationale and design of a multicenter, international and collaborative Coronary Artery Aneurysm Registry (CAAR).

Coronary artery aneurysm is defined as a coronary dilation that exceeds the diameter of adjacent segments or the diameter of the patient's largest normal coronary vessel by 1.5×. It is an uncommon disease that has been diagnosed with increasing frequency since the widespread appearance of coronary angiography. The published incidence varies from 1.5% to 5%, suggesting male dominance and a predilection for the right coronary artery. Although several causes have been described, atherosclerosis accounts for ≥50% of coronary aneurysms in adults. Reported complications include thrombosis and distal embolization, rupture, and vasospasm, causing ischemia, heart failure, or arrhythmias. The natural history and prognosis remain unknown, as definitive data are scarce. Controversies persist regarding the use of medical management (antithrombotic therapy) or interventional/surgical procedures. Only some case reports or small case series are available about this condition. The Coronary Artery Aneurysm Registry (CAAR; http://www.ClinicalTrials.gov NCT02563626) is a multicenter international ambispective registry that aims to provide insights on anatomic, epidemiologic, and clinical aspects of this substantially unknown entity. In addition, the registry will assess management strategies (conservative, interventional, or surgical) and their short- and long-term results in a large cohort of patients. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov. Unique identifier: NCT02563626.

Feasibility of carotid artery stenting with double cerebral embolic protection in high-risk patients.

BACKGROUND: Previous trials comparing carotid artery stenting (CAS) with carotid endarterectomy have shown that the former can increase the stroke rate. However, in the last years, because of the improvements either of the technique or the improvement of the stents and embolic protection devices (EPD), CAS has become a very competitive procedure. In this study, we tried to assess the feasibility and the safety of using double EPD (proximal and distal) in high-risk patients. METHODS: We collected data about all consecutive patients with carotid artery stenosis who underwent CAS and compared clinical and procedural characteristics as well as immediate and 30-day outcomes between the use of double vs. single EPD. RESULTS: Between November 2007 and August 2014, 294 patients underwent CAS. In 35 of them (11.9%) double EPD was used. In comparison with the patients treated with single EPD, those with double EPD presented more with acute carotid syndrome (recurrent TIAs < 48 hr, minor stroke < 14 days) and with complex plaque (79.4 vs. 33.6%, P < 0.0001). There was no difference between the 2 groups in primary success (100 vs. 99.6%, P = 0.16) and in 30-days major complications: death (0 vs. 0.8%, P = 0.6), major stroke (0 vs. 0.8%, P = 0.42), and minor stroke (0 vs 1.1%, P = 0.66). CONCLUSIONS: In our experience, in high-risk patients with high-risk lesions, the use of double EPD (proximal and distal) is safe and effective in minimizing the risk of cerebral embolization, but, to validate such a technique in wide range of patients, further studies are warranted.

[Position paper on the theoretical basis, practical application and health economic evaluation of the functional assessment of coronary lesions endorsed by the Italian Society of Invasive Cardiology (SICI-GISE)]. / Documento di posizione della Società Italiana di Cardiologia Invasiva-Gruppo Italiano Studi Emodinamici (SICI-GISE) sulle basi teoriche, applicazioni pratiche e valutazione economico-sanitaria dell'utilizzo della guida di pressione intracoronarica.

Functional assessment of coronary lesions has become an integral part of routine practice in most cath labs. Such evaluation is performed using a pressure wire that allows measurement of fractional flow reserve (FFR). The latter has received a class I indication with level of evidence A according to the most recent European guidelines on myocardial revascularization for the assessment of angiographically moderate coronary lesions. The present document has the following objectives: 1) to summarize the theoretical basis of FFR; 2) to provide a guideline for vasodilator therapy; 3) to summarize scientific evidence supporting FFR; 4) to provide a model of health economy evaluation focusing on resource sparing associated with the use of FFR.

Postpartum valve thrombosis: a happy ending thriller.

A 29-year-old woman with two mechanical valve prostheses was referred to our institution for sudden and self-resolved diplopia 2 weeks after childbirth. From the beginning of pregnancy, nadroparin was started instead of warfarin. The echocardiogram performed at hospital admission revealed a severe aortic prosthesis regurgitation due to incomplete leaflet apposition with a prosthetic aortic transvalvular gradient increase. Three-dimensional transoesophageal echocardiography revealed a thrombus located between the two prostheses, causing intermittent aortic valve malfunction. Intravenous heparin was started. Three days later, a second transoesophageal echocardiogram revealed a decreased aortic transvalvular gradient, but an oval thrombus adhered to the mitral prosthesis and fluctuating through the prosthetic valve was detected. Tissue plasminogen activator infusion was started. To reduce cerebral embolization, carotid filters used during artery angioplasty were placed in common carotid arteries, left and right. No complication occurred during and after the procedure. With thrombus absence at 30-min transoesophageal echocardiography, filters were removed. The patient continued intravenous heparin until achievement of a therapeutic international normalized ratio range and she was asymptomatic on discharge.

Impact of thrombus aspiration during primary percutaneous coronary intervention in cardiogenic shock complicating ST-segment elevation myocardial infarction.

AIM: To assess the impact on in-hospital and long-term survival of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS). METHODS AND RESULTS: From September 2001 to May 2010 we collected data from 155 patients affected with STEMI complicated by CS undergoing PPCI (12.4% of all PPCI) including 70 patients (45.2%) in TA group and 85 patients (54.8%) in conventional PCI group. Patients in TA group were more likely to have right ventricular infarction (24.3% vs 5.9%, p=0.002), higher mean left ventricular ejection fraction (40% ± 9% vs 35% ± 7%, p<0.0001) and lower left main coronary artery occlusion (2.8% vs 21.2%, p=0.002). TA was associated with a lower rate of in-hospital and long-term mortality (31.4% vs 48.2%, p=0.05 and 42.8% vs 64.7%, p=0.01 respectively) at a mean follow-up time of 6.1 ± 2.1 years. At multivariate analysis the only independent predictor of in-hospital and long-term survival was the procedural success (HR 0.18 95% CI 0.025-0.31, p=0.03 and HR 0.46 95% CI 0.09-0.74, p=0.034 respectively). CONCLUSIONS: In this retrospective study TA, performed during PPCI for STEMI complicated by CS, was not an independent predictor of in-hospital and long-term survival.

Percutaneous coronary intervention in nonagenarian: a meta-analysis of observational studies.

BACKGROUND: Developed countries are facing a sustained increase in life expectancy. Along with all social and cultural implications of increase lifespan, very elderly patients are undergoing percutaneous coronary intervention (PCI) with increasing frequency. However, there is limited evidence to guide clinicians in evaluating pros and cons of PCI in this very frail patient population. We, thus, aimed to perform a systematic review and meta-analysis of clinical studies reporting on PCI with stenting in nonagenarians. METHODS: Studies reporting on five or more nonagenarians undergoing PCI were systematically searched in PubMed (last updated on November 2011). Baseline and clinical characteristics, in-hospital and long-term outcomes were systematically appraised. End points of interest were in-hospital and long-term follow-up incidence of death and Major Adverse Cardiac Events (MACE; i.e. the composite of death from all causes, myocardial infarction or repeat revascularization). Events were pooled with a random-effect model, generating summary estimates of incidence rates [95% confidence intervals (CI)]. RESULTS: A total of 10 studies were included, reporting on a total of 575 nonagenarians undergoing PCI with stenting who represented 1.99% (1.34-2.5) of those undergoing revascularization in the cath lab in a mean period of 5 (3-7) years. Twenty-three percent (13-45) of patients presented with STEMI (ST Segment Elevation Myocardial Infarction), 10% (7-12) with cardiogenic shock and in 78% (64-88) of cases a multivessel disease was diagnosed. Meta-analytic pooling of event rates showed an in-hospital death risk of 12.61% (9.71-15.50) with MACE in 16.41% (13.36-19.47). After a follow-up ranging from 6 to 29 months (median 12), the risk of long-term death was 31.00% (17.10-45.52), with MACE in 37.00% (19.56-55.95; all CI 95%). CONCLUSION: Our meta-analysis, pooling the largest cohort ever of nonagenarians undergoing PCI with stents, confirms the feasibility of percutaneous coronary stenting even in this very frail patient subset, despite the expected severe event attrition during follow-up. Thus, nonagenarians with an acceptable risk profile, recent clinical instability and/or disabling symptoms should not be denied the possibility of percutaneous coronary revascularization.