A new echocardiographic index to select patients for PFO suture-mediated percutaneous closure.

OBJECTIVES: To identify a simple echocardiographic predictor of procedural success to select patient for percutaneous suture-mediated patent fossa ovalis (PFO) closure. BACKGROUND: Percutaneous suture-mediated PFO closure has been shown as a safe and advantageous alternative to device-based PFO closure, yet its overall success is slightly lower in unselected patients. METHODS: Preprocedural transesophageal echocardiogram (TEE) of 302 patients (113 men, 45 ± 12 years) who underwent percutaneous suture-mediated PFO closure were reviewed. RESULTS: At echocardiographic follow-up (3-6 months), residual right-to-left shunt (RLS) ≥2 was found in 60 (19.9%) patients. At multivariable analysis, only two anatomical variables measured at preprocedural TEE were found as independent predictors of residual RLS ≥ 2 at follow-up: PFO maximum width (odds ratio [OR] 1.89, 95% confidence interval [CI] 1.16-3.40, p = 0.02) and PFO minimal septa overlapping (OR 0.58, 95% CI 0.35-0.88, p = 0.02). An index based on the ratio of PFO maximum width to PFO minimum septal overlapping (W/SO) proved to be the most powerful predictor of RLS ≥ 2 at follow-up (OR 48.1, 95% CI 9.3-352.2, p < 0.01). The ROC curve for the W/SO ratio was found to have an AUC of 0.84 (95% CI 0.75-0.93) and a cut-off value of 0.61 yielding a sensitivity of 80% and specificity of 78% with a negative predictive value of 94%. A decision tree methodology's AUC was 0.75 (95% CI 0.67-0.83). CONCLUSIONS: The results of this study indicate that the ratio between the maximum amplitude of the PFO and the minimum overlap of the septa is the best predictive index of a favorable result by using one stitch only.

Atrial function analysis after percutaneous umbrella device and suture-mediated patent fossa ovalis closure.

BACKGROUND: Atrial fibrillation is an undesirable event following percutaneous patent fossa ovalis (PFO) closure with metallic occluders, suggesting that implanting a rigid closure device could alter atrial function. Suture-mediated PFO closure is a new technique, achieving closure of the PFO by means of a simple suture. Aim of this study was to evaluate left atrial function after closure of PFO by direct suture and traditional occluders. METHODS: We studied 40 age and sex homogeneous patients, 20 undergoing PFO closure by device (OCL) and 20 by suturing (NS). Twenty healthy sex-age matched subjects made up the control group (CT). Left atrial function was evaluated by using volumetric and speckle-tracking analysis assessing the following parameters: total emptying fraction (EF), Expansion Index (EI), active emptying fraction (AEF), strain values of the reservoir (r-ED), conduit (cd-ED) and contraction phase (ct-ED). RESULTS: Compared to CT and NS, OCL patients had significantly worst indices of left atrial reservoir function (EF P=0.001, EI P=0.003, r-ED P<0.001), conduit function (cd-ED P=0.018) and contraction function (AEF P=0.010; ct-ED P<0.001). No significant differences were observed in left atrial function indices between CT and NS patients. CONCLUSIONS: Suture-mediated PFO closure does not alter left atrial function. Conversely, metallic occluder is associated with worse left atrium function. This detrimental effect on atrial function could favor the development of atrial arrhythmias.

Percutaneous suture-mediated patent foramen ovale closure: two-year clinical follow-up.

BACKGROUND: Percutaneous suture-mediated patent foramen ovale (PFO) closure has been recently introduced in clinical practice showing a favorable efficacy and safety profile in most PFO cases. The aim of this study was to assess the long-term outcomes of PFO closure by direct suture in a large consecutive series of patients. METHODS: We extracted all consecutive patients who underwent percutaneous closure of the PFO by suture technique (HeartStitch, Fountain Valley, CA, USA) from June 2016 with a follow-up of at least 2 years. After PFO closure, patients were followed-up clinically at 1, 6 and up to 12 months and microbubble transthoracic echocardiography (TTE) scheduled between 3 and 6 months, and at 12-month follow-up. After 12 months, patients were clinically checked every 6 months. RESULTS: As of September 1, 2020, 187 patients had undergone PFO closure with suture for at least two years and, of these, 181 (121 women and 60 men, mean age 45±13 years, range 15-75 years) had complete clinical and instrumental follow-up (97%). There were no peri-procedural complications. Mean follow-up was 1076±251 days (range 727-1574). At 12-month TTE, a significant residual atrial shunt was found in 39 patients (21%). At follow-up no recurrent thromboembolic or cerebral event occurred, no instrumental evidence of suture dehiscence detected and, 18 months after the procedure, one patient had an episode of transient atrial fibrillation lasting less than 24 hours and resolved spontaneously. CONCLUSIONS: Long-term follow-up data indicate that PFO closure by direct suturing is safe and effective. Two years after the procedure, there were no significant complications, no permanent arrhythmic complications and evidence of suture dehiscence.

Predictors of Residual Right-to-Left Shunt After Percutaneous Suture-Mediated Patent Fossa Ovalis Closure.

OBJECTIVES: This study sought to assess patent fossa ovalis (PFO) anatomy by transesophageal echocardiography (TEE) in patients undergoing percutaneous suture-mediated PFO closure to identify predictors of post-procedural residual atrial right-to-left shunt (RLS). BACKGROUND: Percutaneous suture-mediated PFO closure has been proven to be a safe and effective technique in most PFO patients. METHODS: From June 2016 to October 2019, 247 consecutive patients underwent percutaneous suture-mediated PFO closure at our institution. Of them, 230 (46 ± 13 years of age, 146 women) had complete and technically evaluable pre-procedural TEE. The following parameters in short-axis view were assessed: presence and grade of spontaneous RLS, PFO length and width, presence of atrial septal aneurysm and its maximal bulge, and presence of an embryonic or fetal remnant (Chiari network or Eustachian valve). RESULTS: At the first follow-up transthoracic echocardiography performed between 3 and 6 months from the closure procedure, a residual RLS ≥2 grade was found in 37 (16%) patients. Grade of pre-procedural spontaneous RLS (hazard ratio: 1.99; 95% confidence interval: 1.14 to 3.48; p = 0.016) shunt and PFO width (hazard ratio: 2.52; 95% confidence interval: 1.85 to 3.43; p < 0.001) were both found to be significantly associated with significant residual RLS at multivariable analysis. The presence of atrial septal aneurysm and its maximal bulge and of congenital remnants was not associated with significant residual RLS. CONCLUSIONS: Percutaneous suture-mediated PFO closure is feasible in the majority of septal anatomies; however, PFO >5 mm in width and spontaneous large RLS are less likely to be closed with 1 stitch only.

Modified percutaneous suture-mediated patent fossa ovalis closure for prevention of cerebral ischemic events.

Percutaneous suture-mediated transcatheter patent fossa ovalis (PFO) closure has been shown to be an effective and safe technique with self-evident advantages due to the lack of a permanent device heart implant. The success of this novel technique relies on an optimal catch of the interatrial septa, especially the septum primum which is floppier than the bulkier muscular septum secundum. We hypothesized that double suture of septum primum would further improve the efficacy of the procedure by increasing the surface contact between the septa when the septum primum is bent into the right atrium. We have provided proof of this concept by implementing a modified technique in two patients with PFO and cerebral ischemic events.

Concept and practice of transradial 5 French percutaneous treatment of coronary bifurcation lesions.

OBJECTIVES: To assess the efficacy and safety of transradial 5 French percutaneous treatment of coronary bifurcations using conventional devices. BACKGROUND: Radial artery is smaller than femoral artery, and its size may potentially limit transradial intervention, especially when coronary anatomy is not known. METHODS: Patients with bifurcations lesions undergoing transradial 5 French ad hoc revascularization were treated according to provisional side branch (SB) stenting followed by the POT-SB dilation-final POT sequence. Only conventional devices were used. RESULTS: Overall, 80 patients (58 men, 65 ± 10 years) were enrolled. True bifurcations accounted for 64% of cases, with the left anterior descending artery/diagonal branch being the most frequent bifurcation site (n = 37, 46%) and left main coronary artery bifurcation being treated in 6 (8%) patients. Angiographic success was achieved in 78 (97.5%) patients through a 5 French guiding catheter whereas in two cases, a 5-6 French guiding catheter upgrade was required to optimize SB treatment after the main bifurcation vessel have been secured. Overall, procedural success was achieved in all but one patient who had periprocedural necrosis following multivessel PCI. Another patient underwent target bifurcation revascularization because of a critical restenosis in a significant SB yielding an acute coronary syndrome five months after the index procedure. CONCLUSIONS: This study demonstrates the feasibility of transradial 5 French bifurcation intervention with nondedicated devices and preliminary supports its efficacy and safety over a wide range of bifurcation anatomy and complexity.

Novel percutaneous suture-mediated patent foramen ovale closure technique: early results of the NobleStitch EL Italian Registry.

AIMS: The aim of this study was to assess the efficacy of a novel percutaneous "deviceless" suture-mediated patent foramen ovale (PFO) closure system. METHODS AND RESULTS: Between June 2016 and October 2017, a prospective registry aimed at assessing the safety and efficacy of the NobleStitch EL (HeartStitch, Fountain Valley, CA, USA) suture-based PFO closure system was carried out at 12 sites in Italy. Among 200 consecutive patients evaluated, 192 were considered suitable for suture-mediated PFO closure (44±13 years, 114 female). Suture of the septum with the NobleStitch EL system was carried out successfully in 186 (96%) patients. Median fluoroscopy time was 16.1 (13.0-22.5) minutes and contrast volume 200 (150-270) ml. At 206±130 days follow-up, contrast transthoracic echocardiography with the Valsalva manoeuvre revealed no RLS (grade 0) in 139 (75%) patients and RLS grade ≤1 in 166 (89%) patients. Significant RLS was present in 20 (11%) patients (grade 2 and 3 in 11 and nine patients, respectively). There were no device-related complications. CONCLUSIONS: The early results of this first Italian registry indicate that the suture-mediated "deviceless" closure of PFO is feasible in the majority of septal anatomies, and provides an effective closure of PFO comparable to traditional devices with a good safety profile at medium-term follow-up.

Safety and Efficacy of Triple Therapeutic Targets with Rivaroxaban after Acute Myocardial Infarction Complicated by Left Ventricular Thrombi in a Case of Nonvalvular Atrial Fibrillation.

We present the complex case of a high-risk patient with nonvalvular atrial fibrillation, who experienced a non-ST elevation myocardial infarction complicated by left ventricular (LV) thrombi and underwent percutaneous coronary intervention with drug-eluting stent implantation. The patient was initially treated with short-term triple therapy including aspirin, clopidogrel, and rivaroxaban 15 mg/die. Following aspirin dropping one month after discharge, the patient continued on dual therapy with clopidogrel and rivaroxaban, and a clinical and imaging follow-up at 6 and 12 months confirmed the LV thrombi resolution, with no thromboembolic episodes and a good safety profile.

A Beacon in the Dark: Canakinumab. A New Therapeutic Perspective in Chronic Tophaceous Gout.

Gout is the most common form of arthritis in adults. It is often associated with other comorbidities, which contraindicate the use of conventional therapies. The discovery of the role of interleukin-1ß (IL-1ß) in orchestrating the monosodium urate crystal-induced inflammatory response offered new therapeutic prospects to refractory patients, or to those in whom standard therapies are contraindicated. This paper describes a clinical case of a 65-year-old man with chronic tophaceous gouty arthropathy and subintrant flares, who had comorbidities contraindicating the use of conventional gout therapies-to which he did not respond-who was treated with canakinumab, a monoclonal selective inhibitor of IL-1ß. The patient reported a gradual, rapid, and significant reduction in pain, with a response observed within 12 h of the administration of the drug. Consistent with previous clinical studies, canakinumab appeared to be a viable, safe, and effective alternative to conventional therapies in this patient with gout who had limited therapeutic options. FUNDING: Novartis Farma, Italy.

Identifying a better strategy for ad hoc percutaneous coronary intervention in patients with anticipated unfavorable radial access: the Little Women study.

BACKGROUND: Transradial percutaneous coronary intervention (PCI) offers important advantages over transfemoral PCI, including better outcomes. However, when there is indication to ad hoc PCI, a 6 French workflow is a common default strategy, hence potentially influencing vascular access selection in patients with anticipated small size radial artery. METHODS: A multidimensional evaluation was performed to compare two ad hoc interventional strategies in women <160cm: a full 6 French workflow (namely 6 French introducer sheath, diagnostic catheters and guiding catheter) with a modified workflow consisting in the use of 5 French diagnostic catheters preceded by the placement of a 6 French sheath introducer and followed by a 6 French guiding catheter use for PCI. RESULTS: Overall 120 women (68±11years) were enrolled in the study. Coronary angiography has been performed using 5 French or 6 French diagnostic catheters in 57 (47.5%) and 63 (52.5%) cases, respectively. Radial spasm and switch to another access occurred more frequently among women who underwent coronary angiography with 6 French rather than 5 French diagnostic catheters (43% vs. 25%, p=0.03 and 2% vs. 11%, p=0.04, respectively). Total time to guidewire lesion crossing was also significantly higher when PCI has been preceded by 6 French rather than 5 French coronary angiography (23±11min vs 16±7min, p=0.013). CONCLUSIONS: In patients with anticipated unfavorable radial access, a workflow consisting in 6 French introducer sheath placement, 5 French coronary angiography, and 6 French coronary intervention is on multiple parameters the most straightforward and effective strategy.

Angiographic and clinical performance of polymer-free biolimus-eluting stent in patients with ST-segment elevation acute myocardial infarction in a metropolitan public hospital: The BESAMI MUCHO study.

OBJECTIVES: This study aimed at assessing the performance of a new generation polymer-free biolimus-eluting stent (BES) in real-world patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Polymers components of early-generation drug-eluting stents have been implicated in the pathogenesis of delayed arterial healing, vessel remodeling, and delayed stent thrombosis. Recently, a novel polymer-free BES has shown excellent clinical performance in clinical trial setting. METHODS: Overall, 175 consecutive patients (64 ± 14 years, 141 men) treated with the BioFreedom (Biosensors Europe, Morges, Switzerland) polymer-free BES because of STEMI were included in this study. The primary endpoint was the rate of major adverse cardiac events (MACE), a composite of cardiac death, recurrent myocardial infarction, and ischemia-driven target vessel revascularization at 1 year follow-up. A subgroup of patients underwent 6-month angiographic follow-up. Dual antiplatelet therapy was prescribed for 12 months after STEMI. RESULTS: At 1 year, the cumulative rate of MACE was 4.6%. One patient (0.6%) had an arrhythmic cardiac death and five (2.9%) had ischemia-driven target vessel revascularization, although only three (1.7%) had target lesion revascularization. Two (1.1%) patients had acute stent thrombosis yielding nonfatal myocardial infarction. In 70 patients (63 ± 14 years, 61 men), quantitative coronary angiography at 6-month follow-up revealed diameter stenosis of 24.1 ± 13.7% and minimal lumen diameter of 2.29 ± 0.56 mm, yielding a late lumen loss of 0.13 ± 0.14 mm. CONCLUSIONS: In real-world setting, implantation of a new-generation polymer-free BES during STEMI is associated with favorable clinical and angiographic results, pointing toward the overall efficacy and safety of the device in complex clinical scenarios.

AMPLATZER versus Figulla occluder for transcatheter patent foramen ovale closure.

AIMS: The aim of this observational study was to compare acute and 12-month results of percutaneous closure of patent foramen ovale (PFO) with two occluder devices. METHODS AND RESULTS: Between June 2007 and October 2014, 406 consecutive patients (48.1±13.3 years, 243 women) underwent percutaneous PFO closure with either the AMPLATZER (n=179) or the Figulla (n=227) device after a stroke or a transient ischaemic attack ascribed to the PFO. A right-to-left shunt grade >1 was previously detected in all patients and atrial septal aneurysm was present in 111 (27.5%) patients. Patients were followed up with a contrast transthoracic echocardiogram and clinically at 24 hours, six months, and 12 months after the procedure. A high procedural success was observed in both groups. Despite a trend towards a higher incidence of acute residual shunt immediately after device deployment among Figulla occluder patients, a residual grade ≥2 right-to-left shunt was observed in 4.5% of patients, independently of the device used for PFO closure. The only difference reported after Figulla device implantation was a lower rate of supraventricular arrhythmias (9% vs. 17%, p=0.02). CONCLUSIONS: According to this two-centre study, PFO closure appears safe and effective with the Figulla occluder as well as with the AMPLATZER device.

Catheter ablation of idiopathic ventricular tachycardia without the use of fluoroscopy.

BACKGROUND: Catheter ablation is the treatment of choice for many patients with idiopathic ventricular tachycardia (VT). Unfortunately, conventional catheter ablation is guided by fluoroscopy, which is associated with a small but definite radiation risk for patients and laboratory personnel. The aim of our study is to assess feasibility, success rate and safety of idiopathic VT ablation procedure performed without the use of fluoroscopy. METHODS: Nineteen consecutive patients undergoing idiopathic VT ablation at our institution have been included. The ablation procedures were performed under the guidance of electroanatomical mapping (EAM) system and intracardiac echocardiography (ICE). RESULTS: Nineteen patients (mean age 38.7 years) underwent ablation procedure for idiopathic VT. Twelve (63%) had outflow tract VT, 3 (18%) fascicular tachycardia, 2 (11%) peri-tricuspidal VT, 1 (5%) peri-mitral VT, and 1 (5%) lateral left free-wall VT. The mean procedural time was 170.2 ± 45.7 min. No fluoroscopy was used in any procedural phase. Acute success rate was 100%. No complication was documented in any patients. After a mean follow up of 18 ± 4 months, recurrences occurred in 2 patients. CONCLUSIONS: In our preliminary experience idiopathic VT ablation without the use of fluoroscopy was feasible and safe, using a combination of EAM and ICE. Success rate was excellent with no complication.

Cryoablation of typical atrioventricular nodal reentrant tachycardia in children: six years' experience and follow-up in a single center.

BACKGROUND: Cryoablation is an effective and safe treatment for children with supraventricular tachycardias when the reentry circuit is located near the atrioventricular (AV) junction. We retrospectively reviewed consecutive cryoablation procedures for the treatment of atrioventricular nodal reentrant tachycardia (AVNRT) in children and young adults in a single pediatric center. METHODS: From October 2002 to October 2008, cryoablation was attempted in 76 pediatric patients (mean age 11.3 +/- 2.4 years, range: 6-16.4 years) with symptomatic typical AVNRT. Cryomapping, used to identify the tissue site for safe arrhythmia ablation, was performed at -30 degrees C for a maximum of 60 seconds. The efficacy of the cryomapping procedure was assessed in terms of disappearance of dual-AV node physiology and noninducibility of AVNRT. RESULTS: Cryoablations were from 4 to 8 minutes long at -75 degrees C. A single "bonus" cryoapplication (-75 degrees C for minimum 6 minutes) was delivered to consolidate the acutely successful cryoablation for 64 consecutive patients. After the cryoablation procedure, patients were assessed at 1, 3, 6, 12, 18, and 24 months (and then every year thereafter) by a clinical evaluation and standard electrocardiogram, Holter monitoring, and exercise stress testing. No permanent cryo-related complications were reported. Seventy-four (97.4%) patients were successfully acutely ablated. During a mean follow-up of 29.5 months (range 2-74 months), five (6.8%) acutely successful pediatric patients experienced arrhythmia recurrence. We did not identify any predictive factors of AVNRT recurrence. CONCLUSIONS: Acute and long-term results demonstrate that cryoablation of AVNRT can be considered a safe and effective procedure in pediatric patients. (PACE 2010; 475-481).

Transcatheter closure of coronary artery fistula using the new Amplatzer vascular plug and a telescoping catheter technique.

Coronary artery fistulas (CAFs) are rare congenital or acquired anomalies characterized by an abnormal communication between the coronary arteries and the cardiac chambers or great vessels. Most patients are asymptomatic during childhood but symptoms and complications have been reported with advancing age. Until recently, surgery was the routine mode of treatment for CAFs but, today transcatheter closure is recommended using a variety of devices, such as occlusion coils, vascular plugs, umbrella devices and covered stents. The case described here is of a 47-year-old woman with a large bilateral CAF draining into the pulmonary artery, successfully treated by implantation of two Amplatzer vascular plugs using a telescoping catheter technique.

'Time to effect' during cryomapping: a parameter related to the long-term success of accessory pathways cryoablation in children.

AIMS: Cryoablation is an effective treatment for children with an accessory pathway (AP). Nevertheless, AP may recur after a successful procedure. The aim of this study was to identify the factors predictive of AP recurrence. METHODS AND RESULTS: Thirty patients (mean age 12.6 +/- 2.9 years) with acutely successful cryoablation of supraventricular tachycardia caused by a right-sided AP were studied. In 20 patients, a lengthier cryoablation and a single 'bonus' cryoapplication to consolidate a permanent lesion were delivered. During the follow-up (mean duration 20 months, range 4-25), no permanent cryo-related complications occurred. Accessory pathway recurrence was observed in six patients (20%) overall, specifically in 30% of patients who did not undergo a bonus cryoapplication and in 15% of the others. The likelihood of AP recurrence was correlated with the 'time to effect' (TTE), i.e. the time interval between the onset of cryomapping at -30 degrees C and the disappearance of AP conduction. The mean TTE in the patients without AP recurrence was 8.2 +/- 8.4 s, in contrast with 16.7 +/- 9.8 s in the others (P = 0.04). The receiver-operating characteristic (ROC) curve of TTE values demonstrates that if the pathway does not lose its conduction capacity until 10 s after reaching -30 degrees C, the probability of arrhythmia recurrence is higher (area under curve = 0.767, sensitivity 83.3%, and specificity 66.7%). CONCLUSION: The long-term success of cryoablation of right-sided AP is closely correlated to the TTE during cryomapping.

Clinical outcome of patients with diabetes mellitus and chronic total occlusion treated with drug-eluting stents.

OBJECTIVES: The prognosis of patients with chronic total occlusion (CTO) and diabetes mellitus treated with percutaneous coronary intervention (PCI) and drug-eluting stent (DES) implantation is unknown. METHODS: We compared the 12-month outcomes of 52 diabetic patients with CTO after successful PCI who underwent DES implantation with that of 47 patients with diabetes and CTO previously treated with bare-metal stents (BMS). Death, myocardial infarction and repeat PCI or coronary artery bypass surgery were considered as a combined primary endpoint. RESULTS: At 1-year follow up, the primary endpoint occurred in 6% (n = 3) of patients treated with DES and 23% (n = 11) of the patients treated with BMS (p = 0.01). One patient in the DES group and 3 patients in the BMS group died during follow up (p = 0.26). Stepwise logistic regression analysis identified DES (odds ratio [OR] = 12.9, 95% confidence interval [CI] 2.90-57.5; p = 0.0004) and final minimal lumen diameter (odds ratio [OR] = 10.1, 95% CI 1.81-56.4; p = 0.01) as independent correlates of major adverse cardiac events (MACE) at follow up. CONCLUSIONS: In patients with chronic total occlusion, DES were superior to bare-metal stents in reducing the MACE and should be considered a preferred treatment strategy for patients with diabetes and CTO undergoing PCI.