Risk of Dislodgement of Ultrathin Drug Eluting Stents Versus Thick Drug Eluting Stents.

Modern ultrathin struts drug eluting stents (DES), due to their constructive characteristics, might be more prone to stent dislodgment than the old thick DES. Our study is aimed to retrospectively analyze and compare the incidence and outcomes of stents dislodgment in thick (TSS) and ultrathin strut stents (USS).We retrospectively analyzed the procedural and medical data of 8,564 consecutive patients (mean age 64.3 ± 11.2 years old, 4442 males) who underwent percutaneous coronary intervention with DES implantation in our Institution between 1st January 2005 to 1st January 2020. Overall, 25,692 (mean of 3.2 stent for patients) have been implanted over the study period (10648 TSS and 15044 and USS, respectively). Stent dislodgment globally occurred in 0.56% of the implanted stents (0.28% vs 0.78%, p <0.001 for TTS and USS, respectively). Coronary artery calcifications, ostial lesion, coronary artery tortuosity, and a lesion length >25 mm were independent predictors of type I and II USS dislodgments. At 12 months follow up, the rate of target lesion failure was higher in the TTS group (30.7 vs 12.7 %, p <0.001). Stent dislodgement is unusual in the modern era but is more frequent using USS than TTS DES.

Characterization of single vs. recurrent spontaneous coronary artery dissection.

Background Spontaneous coronary artery dissection is a rare non-atherosclerotic cause of acute coronary syndromes, often underdiagnosed based on standard coronary angiography. Moreover, features, presentation, and intravascular imaging of recurrent spontaneous dissections have not been assessed. Methods Patients with recurrent spontaneous coronary artery dissection, who were admitted to our catheterization laboratory over a 10-year period, were identified. Demographic, clinical, angiographic, and intravascular imaging data were reviewed and analyzed, comparing patients with a single event with those who had a recurrence. Results Over the study period, 31 (0.2%, mean age 48.1 ± 8.8 years, 24 females) of 10,954 patients who underwent coronary angiography experienced a single spontaneous coronary artery dissection, and 6 (0.05%, mean age 49.3 ± 10.1 years, 4 females) experienced recurrent spontaneous coronary artery dissection. No patient suffered more than 2 dissections. Arterial hypertension ( p = 0.004), a string sign measuring >15 mm on angiography, and hematoma on intravascular ultrasound imaging were more frequently observed in patients with recurrent spontaneous coronary artery dissection. Conclusions Hypertension, length of the string sign on angiography, and hematoma on intravascular ultrasound imaging might identify patients at higher risk of recurrent spontaneous coronary artery dissection despite a lifelong dual antiplatelet regimen.

Edge-to-Edge Technique to Minimize Ovelapping of Multiple Bioresorbable Scaffolds Plus Drug Eluting Stents in Revascularization of Long Diffuse Left Anterior Descending Coronary Artery Disease.

BACKGROUND: Implantation of Drug Eluting Stents (DES) plus bioresorbable scaffolds (BVS) in very long diffuse left anterior descending coronary artery (LAD) disease may be problematic because of multiple devices overlapping. We sought to assess the short and mid-tern outcomes of combined implantation of DES and BVS using a novel "edge-to-edge" technique in patients with diffuse LAD disease. METHODS: Patients with long diffuse LAD disease were enrolled in a prospective registry from 1st August 2014 to 1st August 2015 and treated with IVUS-aided percutaneous coronary intervention using a DES plus a single or multiple BVS using a novel "edge-to-edge" technique. Clinical follow up and invasive follow up driven by clinical justification was performed. RESULTS: Twenty-three patients (5 females, mean age 59.1± 9.1 years) were enrolled. Mean length of LAD disease was 73.1 ± 20.6 mm. Mean number of DES and BVS implanted was 1.2 ± 0.4 and 1.7 ± 1.3, respectively. At a mean follow-up of 11.3 ± 3.8 months, no stent thrombosis or MACE were observed. Angiographic and IVUS follow-up at a mean of 6.6 ± 0.7 months showed no significant angiographic restenosis and no appreciable stent gaps. CONCLUSIONS: In revascularization of long diffuse disease of the LAD, the edge-to-edge implantation technique appears to be feasible resulting in no restenosis or thrombosis on the short-term follow-up. (J Interven Cardiol 2016;29:275-284).

Incomplete Cor Triatriatum Dexter and Its Clinical and Technical Implications in Interatrial Shunt Device-Based Closure: An Intracardiac Echocardiography Study.

OBJECTIVES: Cor triatriatum dexter (CTD) is a congenital anomaly in which the right atrium is divided into two parts by a membrane or fibromuscular band. Incomplete separation of the right atrium may occur when prominent venous valve remnants such as Eustachian valve (EV) or Chiari network (CN) incompletely divided the right atrium (incomplete CTD-iCTD). We sought to assess the incidence of EV/CN and iCTD and its clinical and technical implications in patients submitted to interatrial shunt transcatheter closure. DESIGN: Retrospective analysis of single center registry. SETTING: Secondary referral center. PATIENTS: Five hundred eighty consecutive patients (mean age 44 ± 15.5 years, 385 females) who had been submitted over a 12 years period to intracardiac echocardiography-aided interatrial shunt catheter-based closure. OUTCOMES MEASURES: Prevalence of iCTD and EV/CN, shunt grade, right ventricle diameter, incidence of intraprocedural complications. RESULTS: In patients with PFO, a prominent EV or a large CN and iCTD have been diagnosed in was diagnosed on ICE in 51.1% and 5.2%, respectively. In ASD patients, a prominent EV or a large CN and iCTD were apparent in 13.7% and 5.6%, respectively. PFO patients with iCTD had more frequently a curtain pattern on TC Doppler and a larger right-to-left shunt graded than prominent EV/CN patients and patients without. ASD patients with iCTD had larger right ventricle diameter than both ASD patients with EV/CN and patients without. iCTD was associated with 45.1% of patients with intraoperative complications. CONCLUSIONS: iCTD are not so infrequently observed by ICE during interatrial shunt closure procedure. Presence of this peculiar structure should be taken in account during device-based procedure in the right atrium.

Pathophysiology of paradoxical embolism: evaluation of the role of interatrial septum anatomy based on the intracardiac echocardiography assessment of patients with right-to-left shunting.

BACKGROUND: Detailed anatomic variants of the interatrial septum in patients with right-to-left shunt and contribution of specific anatomies to the risk of ischaemic recurrences has not yet been comprehensively classified. OBJECTIVE: To report a classification of the anatomic variants of the interatrial septum as observed by intracardiac echocardiography and its correlation with clinical and functional characteristics. METHODS: We retrospectively reviewed the medical and instrumental data of 520 consecutive patients (mean age 44±15. 5 years, 355 women) who had over a 10-year period undergone intracardiac echocardiography and right-to-left shunt catheter-based closure. The four main features used to analyse were: (a) diameter of the oval fossa, (b) presence and length of the channel, (c) presence and degree of atrial septal aneurysm, and (d) rim thickness. The presence of Eustachian valve was also tabulated. RESULTS: The combinations of interatrial septum anatomical features were classified into six main anatomical subgroups. Recurrent embolism, multiple ischaemic foci on brain magnetic resonance imaging, high grade shunt, and permanent shunt before transcatheter closure procedure were associated with type 2, type 4, and type 6. Type 4 anatomical subtype (OR 4.1, 1.5-8 [95% CI], p<0.001) and type 2+presence of Eustachian valve (OR 4.3, 1.6-9 [95% CI], p<0.001) were the strongest predictors of recurrent ischaemic events before transcatheter closure. CONCLUSION: Our study showed that interatrial septum anatomy greatly differs among patients with right-to-left shunt, as well as the risk of ischaemic recurrences in different anatomies.

Clinical, hemodynamic, and intracardiac echocardiographic characteristics of secundum atrial septal defects-related paradoxical embolism in adulthood.

BACKGROUND: Paradoxical embolism associated with secundum atrial septal defect (sASD) is a relatively rare but well-known occurrence. The purpose of our study is to report the clinical, hemodynamic, and anatomical features assessed by intracardiac echocardiography (ICE) of sASD as related to paradoxical embolism. METHODS: Five hundred thirty-seven patients (mean age 48 ± 19.0 years) admitted for transcatheter repair of interatrial shunts were enrolled in a prospective registry over a 10-year period (September 2003-September 2013). All patients underwent transesophageal echocardiography, complete right and left catheterization, prior to the device-based procedure. ICE was performed in all patients in order to investigate the interatrial septum anatomy and to monitor device implantation. These results were compared with the data of patients with patent foramen ovale (PFO) patients and nonemboligenous sASD admitted at the same time period. RESULTS: Twenty-four patients (6.2%) out of 386 who underwent transcatheter repair for paradoxical embolism had a secundum ASD. The defects were cribrosus in 41.6% (10/24). All single sASD (58.3%) had a peculiar anatomical feature a so-called flat elliptical shape with a major axis of 7.6 ± 2.4 and minimal axis of 2.5 ± 1.6 mm. Patients with sASD-related paradoxical embolism had a higher frequency of deep venous thrombosis compared to PFO patients. In comparison to nonemboligenous sASD, such patients had lower mean pulmonary pressure and smaller defects. CONCLUSION: sASD related to paradoxical embolism had peculiar clinical, hemodynamic, and anatomical characteristics, which classified such defects in the middle of the spectrum between nonemboligenous secundum ASD and PFO.

Prolonged high-pressure balloon angioplasty of femoropopliteal lesions: Impact on stent implantation rate and mid-term outcome.

OBJECTIVES: To assess the impact on stent implantation rate and mid-term outcomes of prolonged high pressure angioplasty of femoropopliteal lesions. METHODS: We retrospectively enrolled 620 consecutive patients from January 2011 to December 2011 (75.6 ± 12.3 years, 355 males, 76.5% in Rutherford class 5-6), referred for critical limb ischemia and submitted to prolonged high-pressure angioplasty of femoropopliteal lesions. The definition of prolonged high-pressure angioplasty includes dilation to at least 18 atm for at least 120 s. Procedural data, and clinical and instrumental follow-up were analyzed to assess stent implantation rate and mid-term outcomes. RESULTS: The preferred approach was ipsilateral femoral antegrade in 433/620 patients (69.7%) and contralateral cross-over in 164/620 (26.4%) and popliteal retrograde + femoral antegrade in 23/620 (3.7%). Techniques included subintimal angioplasty in 427/620 patients (68.8%) and endoluminal angioplasty in 193/620 patients (31.2%). The prolonged high pressure balloon angioplasty procedure was successful in 86.2% (minor intra-procedural complications rate 15.7 %), stent implantation was performed in 74 patients (11.9%), with a significant improvement of ankle-brachial index (0.29 ± 0.6 vs. 0.88 ± 0.3, P < 00.1) and Rutherford class (5.3 ± 0.8 vs. 0.7 ± 1.9, P < 0.01), a primary patency rate of 86.7%, restenosis of 18.6 % on Doppler ultrasound and a target lesion revascularization of 14.8% at a mean follow-up of 18.1 ± 6.4 months (range 1-24 months). Secondary patency rate was 87.7%. CONCLUSIONS: Prolonged high pressure angioplasty of femoropopliteal lesions appears to be safe and effective allowing for an acceptable patency and restenosis rates on mid-term.

Usefulness of intracardiac echocardiography with a mechanical probe for catheter-based interventions: a 10-year prospective registry.

BACKGROUND: The clinical outcome benefit of intracardiac echocardiography (ICE) with a mechanical probe during congenital heart disease interventions has not been fully investigated. We reported the long-term results of a prospective registry of interatrial shunt closure guided by mechanical ICE. METHODS: We enrolled 537 patients (mean age 48 ± 19.0 years, 378 females) submitted to ICE-aided procedures in a prospective registry over a 10-year period (September 2003-September 2013). All patients underwent transesophageal echocardiography (TEE) before the planned procedure. We evaluated (1) structure identification capability, (2) fossa ovale and interatrial septum component measurement, (3) procedure monitoring capability, (4) procedural and fluoroscopy times, and radiograph dose, (5) probe-related complications. RESULTS: ICE was successfully performed and was able to correctly identify the structures previously assessed by TEE in all patients. In 24 patients (4.5%), ICE allowed better anatomy definition than TEE. In 35 other patients (6.5%), ICE identified structures not observed by TEE, which led to change indications to interventions or the operative technique to be used. In 131 patients (24.4%), ICE evaluation led to change the planned device to be implanted. There was only one probe-related complication (0.2%). CONCLUSIONS: Mechanical ICE may offer a valid alternative to conventional TEE in guiding congenital heart disease interventional procedures.

Strategies to overcome hostile subclavian anatomy during transradial coronary angiography and interventions: impact on fluoroscopy, procedural time, complications, and radial patency.

BACKGROUND: Hostile anatomy of the subclavian artery (severe tortuosity and/or heavy calcification) remains a significant obstacle for the transradial approach during coronary angiography and interventions. OBJECTIVE: To assess impacts on fluoroscopy and procedural times, complications, and radial artery patency in patients with hostile subclavian anatomy by using multiple catheter-guide techniques. METHODS: We retrospectively reviewed the medical and equipment data of 4,580 consecutive patients (mean age 74.4 ± 26.7 years, 49.5% females) who have been referred for transradial coronary angiography and/or interventions within the last 3 years (September 2010-September 2013). In order to overcome the strangling hold of a hostile subclavian artery, 2 techniques have been used: (1) for a coronary angiography-only procedure, a double mother and child technique; (2) for percutaneous coronary intervention, a triple mother and child technique. RESULTS: Ninety-five patients (2.1%) from the entire study population exhibited a hostile subclavian artery. Fifty-two patients (1.1%) underwent coronary angiography only and 43 patients (1%) underwent interventions requiring the use of the above double or triple mother and child techniques, respectively. The 2 techniques were successful in 94.7% of patients (90/95 patients). The procedural time was significantly longer in the patients with hostile subclavian artery while there were no differences in the fluoroscopy time. The radial artery was patent at 30 days in 92.6% of patients (88/95 patients). CONCLUSION: Our data showed that in the presence of hostile subclavian anatomy, the mother and child techniques appeared safe and effective, allowing for the completion of the intended procedure.

Management of distal/bifurcation left main restenosis after drug eluting stents implantation: single center experience.

OBJECTIVES: Restenosis after drug eluting stent (DES) implantation in the distal/bifurcation left main (DBLM) remains challenging to manage. The aim of this study was to assess the in-stent restenosis (ISR) after DES implantation in DLM and to evaluate current management strategy. METHODS: The medical records of patients referred for LM distal/bifurcation percutaneous coronary interventions (PCI) from the same Cardiology Unit in the January 2007 to December 2012 period were reviewed for PCI technique, stent type, restenosis type, restenosis treatment and management (CABG, balloon angioplasty only, alternative DES implant, drug eluting balloon angioplasty). RESULTS: Fourteen patients (5 females, mean age 75.1±8.3years) out of 89 (15.7%) having undergone a percutaneous coronary interventions on DBLM with DES, developed restenosis (everolimus stents in 10 patients, zotarolimus stents in 4 patients). Technique used at the first implant included stenting of the main branch in 4 patients, culottes stenting in 6 patients and T-stent in 4 patients. The mean time elapsed from the first angioplasty and ISR intervention was 7.6±3.6months. Restenosis treatments included: implantation of a different DES (in 3 patients), implantation of a bare-metal stent (in 2 patients), simple balloon angioplasty (in 4 patients), and drug-eluting balloon (5 patients). At 6-month angiographic control second restenosis rate was 14.2%. After a mean follow-up of 38.5±24.4months the target vessel revascularization was 14.3%: surgery was the final choice in two patients due to recurrent restenosis. Incidence of major adverse cardiac event was 28.5%. CONCLUSIONS: The occurrence of restenosis after DBLM following DES implantation is not frequent but remains difficult to manage. In our small anecdotal series, all the different strategies including implantation of different DES, balloon angioplasty, bare-metal stent implantation and drug-eluting balloon angioplasty appeared equally effective in maintaining arterial patency.

Impact of interatrial septum anatomic features on short- and long-term outcomes after transcatheter closure of patent foramen ovale: single device type versus anatomic-driven device selection strategy.

BACKGROUNDS: We reported the short- and long-term results of our institutional single center registry Interatrial Septum Interventions Study (ISIS) about the impact of different anatomic characteristics and related device selection in patent foramen ovale (PFO) closure. METHODS: Over a 9 year period (September 2003-September 2012) we prospectively enrolled 340 consecutive patients (mean age 44 ± 15. 5 years, 198 females) who had been referred to our center for PFO catheter-based closure. The first 105 patients received a single type of device independently from the anatomy (single device strategy). The remaining 235 patients received a different device based on intracardiac echocardiographic study of interatrial septum anatomy (anatomic strategy). RESULTS: Immediate success rate was 100% in both groups, whereas the rate of immediate complications was 10.4% and 2.5% (P<0.01) in the single strategy group and anatomic strategy group, respectively. During a mean follow-up of 59.3 ± 28.9 months, the occlusion rate was 86.6% and 94%, whereas the incidence of recurrences was 1.8% and 0% in the single device strategy group and anatomic strategy group, respectively. CONCLUSION: The results from ISIS registry showed that anatomy of interatrial septum associated with PFO is quite complex leading to an increased rate of complications and a slightly lower closure rate if treated with a single device strategy.

Safety and long-term outcome of modified intracardiac echocardiography-assisted "no-balloon" sizing technique for transcatheter closure of ostium secundum atrial septal defect.

BACKGROUND: The need for sizing the secundum atrial septal defect (ASD) with the balloon sizing technique is still debated at least in adult patients. We sought to prospectively evaluate the effectiveness of intracardiac echocardiography (ICE)-aided sizing technique for transcatheter closure of secundum ASD, without using a balloon sizing. METHODS: In a prospective 5-year registry, we enrolled 81 patients (mean age 48 ± 13.7 years, 54 females) who had been referred to three different centers for atheter-based closure of secundum ASD. Eligible patients underwent ICE study and closure attempt. In a preliminary group of 21 patients, sizing balloon was performed under ICE guidance to assess the value of rim thickness necessary for device anchorage. In the remaining 60 patients, the retrieved value of the rim thickness was measured on ICE and used as key points to measure the defect and select the device. RESULTS: In the preliminary group of patients, the value of thickness at point of initial deflection by the balloon was 1.23 ± 0.1 mm. ASD diameter in the study group was measured at the point of rim with at least 1.2 mm and the mean ASD diameter was 26.2 ± 10.1 mm. Rates of procedural success, predischarge occlusion, and major complications rate were 100%, 93.3%, and 0%, respectively. On mean follow-up of 5.4 ± 1.8 years, the occlusion rate was 98.7% with no long-term complications. CONCLUSIONS: Our novel ICE-sizing technique appears to be safe and effective in adult patients, thus eventually minimizing overestimation, costs, and potential complications of balloon sizing.

Improving migraine by means of primary transcatheter patent foramen ovale closure: long-term follow-up.

OBJECTIVE: We sought to assess the long-term faith of migraine in patients with high risk anatomic and functional characteristics predisposing to paradoxical embolism submitted to patent foramen ovale (PFO) transcatheter closure. METHODS: In a prospective single-center non randomized registry from January 2004 to January 2010 we enrolled 80 patients (58 female, mean age 42±2.7 years, 63 patients with aura) submitted to transcatheter PFO closure in our center. All patients fulfilled the following criteria: basal shunt and shower/curtain shunt pattern on transcranial Doppler and echocardiography, presence of interatrial septal aneurysm (ISA) and Eustachian valve, 3-4 class MIDAS score, coagulation abnormalities, medication-refractory migraine with or without aura. Migraine Disability Assessment Score (MIDAS) was used to assess the incidence and severity of migraine before and after mechanical closure. High risk features for paradoxical embolism included all of the following. RESULTS: Percutaneous closure was successful in all cases (occlusion rate 91.2%), using a specifically anatomically-driven tailored strategy, with no peri-procedural or in-hospital complications; 70/80 of patients (87.5%) reported improved migraine symptomatology (mean MIDAS score decreased 33.4±6.7 to 10.6±9.8, p<0.03) whereas 12.5% reported no amelioration: none of the patients reported worsening of the previous migraine symptoms. Auras were definitively cured in 61/63 patients with migraine with aura (96.8%). CONCLUSIONS: Transcatheter PFO closure in a selected population of patients with severe migraine at high risk of paradoxical embolism resulted in a significant reduction in migraine over a long-term follow-up.

Long-term results of the amplatzer cribriform occluder for patent foramen ovale with associated atrial septal aneurysm: impact on occlusion rate and left atrial functional remodelling.

BACKGROUND: Treatment of patients with concomitant patent foramen ovale (PFO) and atrial septal aneurysm (ASA) poses a number of challenges; while some authors have suggested the off-label use of the Amplatzer Cribriform Occluder in such anatomy, the long-term outcomes of this strategy is unknown. Our study aimed to assess the long-term impact on closure rate, left atrial functional remodelling, and clinical outcomes of off-label implantation of Amplatzer ASD Cribriform Occluder in patients with PFO and ASA. METHODS: We prospectively enrolled 160 consecutive patients with previous stroke (mean age 36 ± 9.5 years, 109 females), significant PFO and ASA. All patients were treated with Amplatzer Cribriform Occluder to ensure the most complete possible coverage of the ASA. Residual shunt and LA passive and active emptying, LA conduit function, and LA ejection fraction were computed before and after 6 months from the procedure and then yearly. All patients underwent successful transcatheter closure (mean ratio device/diameter of interatrial septum = 0.74). RESULTS: Incomplete ASA coverage during intraprocedural intracardiac echocardiography was observed in 71 patients. During mean follow-up of 3.6 ± 1.8 years, when compared to patients with complete coverage, there were no differences in LA functional parameters and complete occlusion achieved in 150/160 patients (93.7%). No new cerebral ischemic events, aortic erosions or device thrombosis were recorded during the follow-up. CONCLUSIONS: THE USE OF THE AMPLATZER ASD CRIBRIFORM TO TREAT PFO AND ASSOCIATED ASA SEEMS SAFE AND EFFECTIVE: relatively small Occluder devices are probably effective enough to promote left atrial functional remodelling.