The RISE Study: Retrospective Registry for the International Safety and Efficacy Results of Patent Foramen Ovale Closure with Figulla Flex Il PFO and UNI Occluders.

Background: Transcatheter closure of a patent foramen ovale (PFO) is performed in cryptogenic stroke and other conditions. Information is lacking for some devices. Methods: We aimed to evaluate the Figulla Flex II PFO Occluder (FFP) and Figulla Flex UNI Occluder (FFU) through a retrospective multi-center registry. Results: 527 patients were included. Mean age was 48.9 (±13.8) years. The procedure was under transthoracic, transesophageal or intracardiac echocardiography in 185 (35.1%), 193 (36.6%) and 149 (28.3%) cases, respectively, and under general anesthesia in 191 patients (36.2%). The FFP and FFU were used in 408 (77.4%) and 119 (22.6%) cases, respectively. The success rate was 99.1%. Median follow-up was 1.1 (0.5-2.5) years. A new atrial fibrillation/flutter within six months occurred in 14 (2.7%) cases, with no difference between devices. One device embolization in the pulmonary artery was identified two years post-procedure. Residual shunts occurred in 18 (6.9%) cases at 1 year, with TIA in three (16.6%) patients. Out of 437 patients with stroke/TIA, 260 (59%) were followed more than one year after closure. Median follow-up was 2.1 (1.17-3.1) years, with four recurrent strokes/TIA. Conclusions: The FFP and FFU devices are safe and effective for PFO closure, with very few atrial fibrillation/flutter and neurologic events, except in cases with a residual shunt.

Patent foramen ovale closure with the Occlutech Figulla flex II device: A long-term (up to 10-years) follow-up.

BACKGROUND: Percutaneous closure represents the first line of treatment in patients with cryptogenic stroke and documented patent foramen ovale (PFO). Scarce data report the long-term outcomes of patients undergoing PFO closure with the Figulla Flex II device (Occlutech, Germany). METHODS: Consecutive patients undergoing PFO closure with a Figulla Flex II device at a single, high-volume Institution were included. Baseline clinical and procedural features were collected and patients were followed up for up to 10 years. The device's long-term safety was assessed, as well as mortality, recurrent cerebrovascular events, new-onset atrial fibrillation (AF) and residual shunt. RESULTS: Overall, 442 patients were included. The main indication for PFO closure was cryptogenic stroke/transitory ischemic attack (65.5%), followed by migraine (21.7%), silent lesions at MRI (10.8%), and decompression disease (2.0%). Atrial septal aneurysm was present in 20.8% of cases, Eustachian valve in 9.0%, Chiari network in 19.9%. The most frequently implanted device was the 23/25 mm (49.5% of cases). One procedural failure due to device embolization; in-hospital complications occurred in 15 cases (3.4%; 4 minor access site complications, 11 transient supraventricular tachycardias (SVT)/AF). After a follow-up of 9.2 years, 2 patients suffered recurrent TIA (with no residual R-L shunt detected). A moderate or severe residual shunt was observed in 3 patients after discharge. CONCLUSIONS: Figulla Flex II devices for PFO closure are associated with high procedural success and low incidence of adverse events even at long-term follow-up.

Diagnostic accuracy of subendocardial vs. transmural myocardial perfusion defect for the detection of in-stent restenosis or progression of coronary artery disease after percutaneous coronary intervention.

BACKGROUND: The ADVANTAGE study demonstrated in a cohort of stented patients a diagnostic accuracy of stress myocardial CT perfusion (CTP) significantly higher than that of coronary CT angiography (CCTA) for the detection of in-stent restenosis (ISR) or CAD progression vs. quantitative coronary angiography (QCA). This is a pre-defined subanalysis of the ADVANTAGE aimed at assessing the difference in terms of diagnostic accuracy vs. QCA of a subendocardial vs. a transmural perfusion defect using static stress CTP. METHODS: We enrolled consecutive patients who previously underwent coronary stenting and were referred for QCA. All patients underwent stress CTP and rest CTP â€‹+ â€‹CCTA. The diagnostic accuracy of CCTA and CTP were evaluated in territory-based and patient-based analyses. We compared the diagnostic accuracy of "subendocardial" perfusion defect, defined as hypo-enhancement encompassing >25% but <50% of the transmural myocardial thickness within a specific coronary territory vs. "transmural" perfusion defect, defined as hypo-enhancement encompassing >50% of the transmural thickness. RESULTS: In 150 patients (132 men, mean age 65.1 â€‹± â€‹9.1 years), the diagnostic accuracy of subendocardial vs. transmural perfusion defect in a vessel-based analysis was 93.5% vs. 87.7%, respectively (p â€‹< â€‹0.0001). The sensitivity and specificity of subendocardial vs. transmural defect were 87.9% vs. 46.9% (p â€‹< â€‹0.001) and 94.9% vs. 97.9% (p â€‹= â€‹0.004), respectively. In a patient-based analysis, the diagnostic accuracy of the subendocardial vs. transmural approach was 86.6% vs. 68% (p â€‹< â€‹0.0001). CONCLUSIONS: This study shows that detection of a subendocardial perfusion defect as compared to a transmural defect is significantly more accurate to identify coronary territories with ISR or CAD progression.

The 'Trawl Fishing' Technique: A Quick Engagement of the Left Common Carotid Artery With the Simmons Catheter During Carotid Artery Stenting From the Right Radial Approach.

BACKGROUND: Transradial approach for carotid artery stenting (TRCAS) is an established technique in specific anatomies potentially associated with high periprocedural event rate from femoral catheterization. The engagement of left common carotid artery originating from the aortic arch is the most challenging scenario requiring specific catheters and techniques. METHODS: Among 542 consecutive TRCAS 66 had left, non-bovine carotid stenosis as the target vessel. We retrospectively compared the feasibility, safety, efficacy, fluoroscopy time and radiation exposure of two different techniques, the standard (ST) and the 'trawl-fishing' (TFT), to engage the LCCA with the 5F, 125 cm-long Simmons-2 catheter. RESULTS: The ST was initially used in 20 patients with a technical success of 85 % (17/20). In the following 46 patients, the TFT was successfully tested first as bailout after ST failure in 12 cases and as first option in the remaining 34 patients. Full technical success was obtained in all patients at the first attempt. No MACCEs or vascular complications occurred in all patients. Fluoroscopy time and radiation exposure were significantly lower with the TFT vs. ST (p < 0.001). CONCLUSIONS: TFT represents a definite improvement in the technique of LCCA engagement during TRCAS.

Transradial/brachial carotid artery stenting with proximal protection: technical instructions, acute results and long-term outcomes.

BACKGROUND: The aim of this study was to evaluate the feasibility, safety and efficacy of transradial/brachial (TR/TB) carotid artery stenting (CAS) with proximal cerebral protection (PCP) as a first line of treatment of carotid artery stenosis. METHODS: Among 556 patients with significant (>50% if symptomatic or >70% if asymptomatic by Doppler US) unilateral, lipid-rich carotid artery stenosis undergoing TR/TB CAS, 137 (24.5%) deemed at high-risk for periprocedural cerebral embolization were scheduled for PCP with Mo.MA Ultra or Mo.MA mono-balloon. In patients with very complex anatomy the standard technique was modified loading the Mo.MA catheter without mandrel on two-wire system (so called 'No MAndrel 2 wire' technique, No.MA2) to increase support and deliverability. Device, technical and procedural successes both acute and at follow-up were the main outcomes. RESULTS: Mean patients' age was 74±7 years (93% male), 15% were symptomatic and 59.6% owned 'high-surgical-risk' features. Stenosis degree was 85±7% with soft composition in all (by CT-angiography). TR and TB approach were selected in 92 (67%) and 45 (33%) patients, respectively. Target carotid axes were right, left bovine and left non bovine in 55%, 38% and 7% of patients. Procedures were successfully completed in all patients (intention-to-treat basis) with the standard Mo.MA Ultra system in 129 patients and the Mo.MA mono-balloon in 8 patients. No.MA2 technique was succesfully used in 16 patients as 'bailout' and in 27 patients as 'first line'). Device and technical success was 97% (133/137 patients) due to crossover to femoral access in 3 cases, and Mo.MA too short to engage the ECA in 1 patient. The procedural success was 96.7% (131/137, two minor strokes). Procedural time and fluoroscopy time were increased with No.MA2 technique. One major vascular complication occurred, in the TB group, while chronic radial occlusion was detected by Doppler ultrasound in 7/92 patients (7.1%) at 372±163 days of follow-up. The event-free survival was 91% and the stroke rate was 0%. CONCLUSIONS: TR/TB CAS with proximal protection is a feasible, safe and effective strategy and may be considered a first line strategy in all comer patients.

Migraine in Patients Undergoing PFO Closure: Characterization of a Platelet-Associated Pathophysiological Mechanism: The LEARNER Study.

The association between migraine and patent foramen ovale (PFO) has been documented. We aimed to investigate platelet activation, prothrombotic phenotype, and oxidative stress status of migraineurs with PFO on 100 mg/day aspirin, before and 6 months after PFO closure. Data show that, before PFO closure, expression of the classical platelet activation markers is comparable in patients and aspirin-treated healthy subjects. Conversely, MHA-PFO patients display an increased prothrombotic phenotype (higher tissue factorpos platelets and microvesicles and thrombin-generation potential), sustained by an altered oxidative stress status. This phenotype, which is more controlled by P2Y12-blockade than by aspirin, reverted after PFO closure together with a complete migraine remission. (pLatelEts And MigRaine iN patEnt foRamen Ovale [LEARNER]; NCT03521193).

Early Detection of Cardiovascular Risk Factors and Definition of Psychosocial Profile in Women Through a Systematic Approach: The Monzino Women Heart Center's Experience.

Introduction: Cardiovascular (CV) disease is the leading mortality cause among women, yet an alarming misrepresentation of women in CV studies and a low awareness of the impact of CV among women still persist to date. The Monzino Women Heart Center has been established as a clinical and research program dedicated to primary prevention of CV disease in women. Methods: Patients aged between 35 and 60 years and with no history of CV disease underwent a comprehensive evaluation including a cardiologic outpatient visit with electrocardiogram, individual CV risk calculation, first-level cardiovascular examinations and a psychological assessment. Results: A total of 635 women, with a mean age of 52.2 ± 6.4 participated to the project on a voluntary basis during the period January 2017-August 2021. Included patients had a high level of education (40.4% with a graduate or postgraduate university degree), the majority of them, in a stable couple and with children, were actively working. More than half of the patients performed physical activity on a regular basis. Prevalence of traditional CV risk factors were family history (70.2%), hypertension (46%), hypercholesterolemia (22%) and diabetes (14%). Early or premature menopause was reported by 17.7% of the patients, gestational hypertension and diabetes by 4.96 and 1.7%, respectively. Symptoms of depression were reported by 27%; nearly 36% of the participants rated high score of state anxiety and 41% of trait anxiety. Nearly 69% of the participants showed moderate-to-high perceived stress. The mean value of perceived general self-efficacy was moderate (mean = 28.78, SD = 4.69). Conclusion: A CV prevention program dedicated to women can help identifying a considerable number of patients with risk factors for whom early interventions can help reducing the risk of developing CV disease. Psychological assessment might unmask depression or anxiety disorders, which might have a potential long-terme detrimental effect on CV health.

The Role of Multimodality Imaging in Left-Sided Prosthetic Valve Dysfunction.

Prosthetic valve (PV) dysfunction (PVD) is a complication of mechanical or biological PV. Etiologic mechanisms associated with PVD include fibrotic pannus ingrowth, thrombosis, structural valve degeneration, and endocarditis resulting in different grades of obstruction and/or regurgitation. PVD can be life threatening and often challenging to diagnose due to the similarities between the clinical presentations of different causes. Nevertheless, identifying the cause of PVD is critical to treatment administration (thrombolysis, surgery, or percutaneous procedure). In this report, we review the role of multimodality imaging in the diagnosis of PVD. Specifically, this review discusses the characteristics of advanced imaging modalities underlying the importance of an integrated approach including 2D/3D transthoracic and transesophageal echocardiography, fluoroscopy, and computed tomography. In this scenario, it is critical to understand the strengths and weaknesses of each modality according to the suspected cause of PVD. In conclusion, for patients with suspected or known PVD, this stepwise imaging approach may lead to a simplified, more rapid, accurate and specific workflow and management.

Absolute and relative contraindications to proximal protection: do they really matter? A case-illustrative approach.

Carotid artery stenting (CAS) is an established technique to treat carotid artery stenosis. Favorable results have been reported in different subsets of patients in both acute and long-term settings. Among the CAS periprocedural variables the type of cerebral protection - distal filter and proximal protection - play a pivot role to reduce cerebral embolization. Accumulating evidence is in favor of better performance of proximal protection vs. distal filters. However, the rate of worldwide penetration of this devise is low. Potential reasons include a lengthy list of technical issues that may account for the reluctance of filter-oriented operators to change systems. This paper shows how to identify, treat, and overcome these technical obstacles.

Intolerance to occlusion during carotid artery stenting with proximal protection: causes, mechanisms, treatment and prevention.

Periprocedural cerebral microembolization is the most important complication of carotid artery stenting. Among several variables that play a role to reduce this risk, brain protection (proximal vs. distal) plays a pivot role. Data are accumulating in favor of a better performance of proximal vs. distal especially in symptomatic patients and high-risk carotid plaques. A prerequisite for the technique to be safe and effective is the presence of a valid intracranial collateral circulation to compensate for the target vessel hemisphere avoiding patient intolerance. This complication may occur either soon after the common carotid balloon occlusion or slowly developing during the procedure peaking at the stent post-dilation step. While Willis' circle anatomic variants are the most frequent cause of acute intolerance, a mix of anatomic, hemodynamic and patient cerebral condition play a role for the late developing form. Prevention is the best treatment of intolerance through a pre- and procedural imaging with different techniques (CT angiography, NMR angiography, transcranial Doppler assessment, digital subtraction angiography and back pressure monitoring).

Spontaneous Coronary Artery Dissections: A Systematic Review.

Myocardial infarction with nonobstructive coronary artery disease due to spontaneous coronary artery dissection (SCAD) accounts for 5-8% of acute coronary syndrome (ACS) presentations. The demographic characteristics, risk factors, and management of patients with SCAD differ from those with atherosclerotic disease. The objective of this review is to provide a contemporary understanding of the epidemiology, pathophysiology, clinical presentation, and management of SCAD.

Case Report: A Cluster of Complications During Carotid Artery Stenting Managed With Peripheral, Coronary, and Imaging Techniques.

We describe the case of a 72-year-old man with severe, asymptomatic in-stent restenosis detected 4 years after index carotid artery stenting (CAS). The patient was deemed at low risk and scheduled for re-angioplasty with a drug-coated balloon as per institution protocol. What at first seemed a simple case suddenly turned into a series of cerebral and vascular complications that were successfully managed with a mix of peripheral, coronary, and imaging techniques.

Detection of Mechanical Prosthetic Valve Dysfunction.

The long-term outcome of mechanical aortic and mitral prosthetic valve (A-PV, M-PV) dysfunction (PVD) remains a serious complication associated with high morbidity and mortality. We sought to evaluate the incremental diagnostic value of combined transthoracic echocardiography (TTE) and fluoroscopy (F) in patients with suspected PVD. A total of 354 patients (178 A-PV, 176 M-PV) were imaged by TTE and F within 5 days of hospital admission. PVD was confirmed by transesophageal echocardiography, computed tomography, effective thrombolysis, or surgical inspection. PVD was confirmed in 101 patients (57%) with M-PV and 99 (55%) with A-PV. Regardless of the mechanism of PVD, TTE shows good sensitivity and specificity, with accuracy of 80% for M-PV and 91% for A-PV. F shows high specificity, but low sensitivity with accuracy of 68% for M-PV and 78% for A-PV. The integration of TTE + F significantly improved accuracy both for M-PV (83%) and A-PV (96%). At ROC analysis, the combined model of TTE + F showed the highest area under the curve for the detection of PVD compared with TTE and F alone (p < 0.001). In conclusion, in patients with a clinical suspicion of PVD, the combined model of TTE + F offers incremental value over TTE or F alone. This multimodality imaging approach overcomes limitations of TTE or F alone and provides prompt identification of patients who may require further imaging assessment and/or closer follow up.

Gender-Associated Outcomes Following Percutaneous Coronary Intervention With a Third-Generation, Ultrathin-Strut Drug-Eluting Stent: A Real-World, Single-Center Experience.

INTRODUCTION: In recent years, the new third-generation ultrathin bioresorbable-polymer sirolimus-eluting stent (BP-SES), characterized by some of the thinnest struts among commercially available devices (60-80 µm) and an amorphous silicon carbide coating, has been introduced for the treatment of coronary artery disease (CAD). The present study aimed to assess different clinical outcomes and safety of this drug-eluting stent in male and female patients in a real-world setting. METHODS: The present study is a retrospective analysis including all patients treated with BP-SES between January 2017 and December 2019 at a single high-volume center. Follow-up data, including stress test results and clinical setting, were collected during outpatient visits or by telephone contact. Patients symptomatic for angina or with a positive stress test were addressed to CT scan/coronary angiogram. The main study outcome was target lesion failure (TLF), defined as a composite of cardiovascular death, target vessel myocardial infarction, or target lesion revascularization. RESULTS: Overall, 66 (15.9%) female and 349 (84.1%) male patients were included; women were older (median age 70 vs. 66, P = 0.003) and with a lower body mass index (BMI) (25.0 vs. 26.1, P = 0.010) compared to men, with no other relevant differences in baseline characteristics. Indication for percutaneous coronary intervention (PCI) was acute coronary syndrome in 86 (20.7%) of the cases, with no significant differences between male and female patients. A total of 558 lesions were treated with BP-SES stents, 90 in women and 468 in men (1.36 vs. 1.34 lesions per patient, P = 0.83); cumulative stent length (33.6 vs. 38.4 mm, P = 0.078), and mean stent diameter (2.92 vs. 3.0 mm, P = 0.39) did not differ in women compared to men. Technical and clinical successes were achieved in all patients. Stent thrombosis (ST) occurred in 2 (0.5%) patients, both men. TLF occurred in 10 (2.9%) men and 2 (3.0%) women after a median follow-up of 402 days, without significant differences at log-rank analysis (2.34 events per 100 patient-years in men, 2.53 in women; P = 0.80). CONCLUSION: Ultrathin struts BP-SES showed to be a safe and effective option for the treatment of CAD in both women and men, with a very low ST rate and favorable long-term outcomes.

A severe right-to-left intracardiac shunt after NobleStitch failure: when a device is needed.

BACKGROUND: Transcatheter closure of patent foramen ovale (PFO) has been demonstrated to be superior to medical therapy in stroke prevention in selected patients. Beyond traditional permanent metallic devices, NobleStitch EL, a suture-based system, has been developed as a potential alternative. CASE SUMMARY: A 50-year-old man underwent transcatheter closure of PFO with mild interatrial septal bulging and tunnel-like morphology with a NobleStitch device. A transthoracic echocardiography performed immediately after PFO closure showed residual shunt (RS), which persisted unchanged at staged controls, due to the inability of the delivery system to capture both the septum primum and the septum secundum. A second procedure was performed with the implantation of a Figulla Flex II 27/30 mm device, with no RS detectable at control echocardiography. DISCUSSION: The NobleStitch device is interesting in its concept, but several pitfalls may be encountered during its deployment. Opposite to permanent metallic devices, RSs after the procedure are not expected to decrease over time and should be managed with a different approach.

A Sex-Based Analysis From the RAIN-CARDIOGROUP VII Study (VeRy Thin Stents for Patients With Left MAIn or BifurcatioN in Real Life) on Left Main Stenting.

INTRODUCTION: There is a lack of data on clinical outcomes of percutaneous coronary intervention (PCI) with ultrathin stents on unprotected left main (ULM) coronary artery comparing women and men. METHODS: All patients treated with ULM-PCI with ultrathin stents (struts ≤81 µm) enrolled in the RAIN-CARDIOGROUP VII study were analyzed according to a sex-assessment evaluation. Major adverse cardiovascular event (MACE, a composite of all-cause death, myocardial infarction, target-lesion revascularization [TLR], and stent thrombosis) was the primary endpoint, whereas single components of MACE were the secondary endpoints. RESULTS: Out of a cohort of 793 patients, a total of 172 women (21.7%) and 621 men (78.3%) were included. Compared with men, women were older and less frequently smokers, had more frequently a history of previous PCI, and presented more frequently with an acute coronary syndrome. Among women, ostial lesions were more prevalent and mean stent diameter was lower compared with men. After 13.4 months (range, 8.4-21.6 months), 32 women (18.6%) and 106 men (17.1%) experienced MACE (P=.64). Censoring follow-up data at 3 years, no differences were observed in MACE (16.9 vs 14.7 per 100•patient-years; log-rank P=.61) and their single components between women and men. At multivariate analysis, chronic kidney disease (hazard ratio [HR], 1.91: 95% confidence interval [CI], 1.23 to -2.95; P<.01) and acute coronary syndrome presentation (HR, 1.84; 95% CI, 1.22-2.77; P=.01) were independent predictors of MACE overall. Larger stent size (HR, 0.65; 95% CI, 0.48-0.89; P<.01) and longer dual-antiplatelet therapy duration (HR, 0.95; 95% CI, 0.90-0.99; P=.03) were associated with a reduced risk of MACE during the subsequent follow-up. CONCLUSION: Ultrathin stents offer low rates of MACE and TLR in the overall population without significant differences between sexes.

Acute Anterior STEMI in Multivessel Spontaneous Coronary Dissections.

Spontaneous coronary artery dissection (SCAD) has a prevalence between 0.2%-4% of all acute coronary syndromes. Multivessel SCAD is unusual. Coronary revascularization remains appropriate for unstable patients or with compromised coronary blood flow. Additionally, IVUS probe advancement and its retrieval could precipitate a dramatic progression of SCAD both distally and proximally to its original site.