Publications by authors named "Antonella De Santis"

35 Publications

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

JACC Cardiovasc Interv 2020 09;13(18):2112-2120

Division of Cardiology, Santa Maria Goretti Hospital, Latina, Italy.

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.
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http://dx.doi.org/10.1016/j.jcin.2020.06.004DOI Listing
September 2020

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

Catheter Cardiovasc Interv 2020 09 21;96(3):638-642. Epub 2020 Apr 21.

Division of Cardiology, Ospedale Sant'Eugenio, Rome, Italy.

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.
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http://dx.doi.org/10.1002/ccd.28936DOI Listing
September 2020

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

Catheter Cardiovasc Interv 2019 02 8;93(3):390-397. Epub 2018 Oct 8.

Division of Cardiology, Sant'Eugenio Hospital, Rome, Italy.

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.
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http://dx.doi.org/10.1002/ccd.27844DOI Listing
February 2019

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.

Case Rep Cardiol 2018 5;2018:6503435. Epub 2018 Mar 5.

Department of Cardiology, San Eugenio Hospital, Rome, Italy.

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.
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http://dx.doi.org/10.1155/2018/6503435DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5859800PMC
March 2018

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

EuroIntervention 2018 06 8;14(3):e272-e279. Epub 2018 Jun 8.

U.O.C. di Cardiologia, Ospedale S. Eugenio, ASL Roma 2, Rome, Italy.

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.
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http://dx.doi.org/10.4244/EIJ-D-18-00023DOI Listing
June 2018

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

Rheumatol Ther 2018 Jun 9;5(1):303-310. Epub 2018 Mar 9.

Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

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-1β (IL-1β) 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-1β. 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.
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http://dx.doi.org/10.1007/s40744-018-0104-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5935617PMC
June 2018

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

Cardiovasc Revasc Med 2018 06 16;19(4):413-417. Epub 2017 Oct 16.

Sant'Eugenio Hospital, Rome, Italy.

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.
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http://dx.doi.org/10.1016/j.carrev.2017.10.006DOI Listing
June 2018

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.

Catheter Cardiovasc Interv 2018 04 2;91(5):851-858. Epub 2017 Aug 2.

Sant'Eugenio Hospital, Rome, Italy.

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.
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http://dx.doi.org/10.1002/ccd.27206DOI Listing
April 2018

AMPLATZER versus Figulla occluder for transcatheter patent foramen ovale closure.

EuroIntervention 2017 Apr;12(17):2092-2099

Centro Cardiologico "Monzino" IRCCS and Department of Cardiovascular Sciences, University of Milan, Milan, Italy.

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.
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http://dx.doi.org/10.4244/EIJ-D-15-00499DOI Listing
April 2017

Closure of patent foramen ovale: do meta-analyses do justice?

J Cardiovasc Med (Hagerstown) 2017 01;18 Suppl 1:e121-e124

Division of Cardiology, S. Eugenio Hospital, Rome, Italy.

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http://dx.doi.org/10.2459/JCM.0000000000000463DOI Listing
January 2017

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

Int J Cardiol 2015 17;190:338-43. Epub 2015 Apr 17.

Department of Medicine, Cardiovascular Section, San Eugenio Hospital, Rome, Italy.

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.
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http://dx.doi.org/10.1016/j.ijcard.2015.04.146DOI Listing
February 2016

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

Pacing Clin Electrophysiol 2010 Apr 1;33(4):475-81. Epub 2009 Dec 1.

Pediatric Cardiology Department, Bambino Gesù Hospital, Rome, Italy.

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).
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http://dx.doi.org/10.1111/j.1540-8159.2009.02623.xDOI Listing
April 2010

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

J Cardiovasc Med (Hagerstown) 2010 Aug;11(8):605-9

Interventional Cardiology, Department of Cardiovascular Medicine, S. Camillo Forlanini Hospital, Rome, Italy.

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.
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http://dx.doi.org/10.2459/JCM.0b013e3283313504DOI Listing
August 2010

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

Europace 2009 May 5;11(5):630-4. Epub 2009 Mar 5.

Paediatric Cardiology Department, Bambino Gesù Hospital, Piazza Sant'Onofrio 4, 00165 Rome, Italy.

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.
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http://dx.doi.org/10.1093/europace/eup045DOI Listing
May 2009

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

J Invasive Cardiol 2008 Dec;20(12):651-4

UO Cardiologia Interventistica Ospedale S Camillo, Rome, Italy.

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.
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December 2008

Transcatheter ablation of supraventricular tachycardias in pediatric patients.

Curr Pharm Des 2008 ;14(8):788-93

Department of Cardiology, San Camillo De Lellis Hospital, Rieti, Italy.

Ablation has become an important treatment for many pediatric patients with common supraventricular tachycardias (SVTs). Many multicenter studies have documented that radiofrequency (RF) catheter ablation is a safe and effective procedure for treatment of a large variety of SVTs in children and adults with a high success rate and minimal complications. Novel electrophysiology technologies such as electroanatomic mapping and sophisticated ablating catheters have improved success rates and decreased complications of transcatheter ablation. Moreover, within the last several years, a new energy source using cryoenergy has evolved as a safe and effective alternative for catheter ablation for arrhythmogenic substrates traditionally associated with increased risk when using RF ablation. In this review pediatric transcatheter ablation practice is analysed and discussed with reference to current clinical guidelines.
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http://dx.doi.org/10.2174/138161208784007680DOI Listing
June 2008

Paroxysmal reciprocating supraventricular tachycardia in infants: electrophysiologically guided medical treatment and long-term evolution of the re-entry circuit.

Europace 2008 May 2;10(5):629-35. Epub 2008 Apr 2.

Paediatric Cardiology Department, Bambino Gesù Paediatric Hospital, Piazza Sant' Onofrio 4, 00165 Rome, Italy.

Aims: The aim of this study is to evaluate the long-term prognosis in infants affected by paroxysmal reciprocating supraventricular tachycardia (SVT), to identify predictors of SVT disappearance, and to assess the efficacy of electrophysiologically guided drug therapy in preventing recurrences.

Methods And Results: A six step regimen of oral therapy was used in 55 infants with SVT: (i) propafenone (P); (ii) flecainide (F); (iii) flecainide plus propranolol (FP); (iv) amiodarone (A); (v) amiodarone plus propranolol (AP); (vi) amiodarone plus flecainide plus propranolol (AFP). If one step was not successful, the patient was passed on to the next treatment step and so on. Transesophageal atrial pacing (TAP) was used to evaluate treatment efficacy and the evolution of SVT at the end of the first, second, and third year. Propafenone was successful in 32.7% of the patients, F in 14.5%, FP in 23.6%, A alone in 5.4%, and AP in 18.1%; only 7.2% reached step 6. At month 12, after therapy wash out, SVT recurred spontaneously in 2 patients (3.6%) and remained inducible in 25 (45.5%). Inducibility was significantly higher in patients treated with A. At 24 months, SVT was inducible or spontaneous in 86% of the cases and at 36 months in 87%. There were no recurrences using the treatment confirmed by TAP. No further predictor of SVT inducibility was identified.

Conclusion: Supraventricular tachycardia disappeared in approximately 50% of the patients during the first year of life and in another 20% thereafter. The necessity for A treatment is the only predictor of persistence of the re-entry circuit during the first year of life. Transesophageal atrial pacing is useful in guiding the medical treatment.
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http://dx.doi.org/10.1093/europace/eun069DOI Listing
May 2008

Circadian pattern of atrial pacing threshold in the young.

Europace 2008 Feb;10(2):147-50

Dipartimento Medico-Chirurgico di Cardiologia, Ospedale Pediatrico Bambino Gesù, Piazza S. Onofrio 4, 00165 Roma, Italy.

Aim: The aim of this study was to evaluate the circadian variation of atrial pacing threshold in young patients.

Methods And Results: Atrial Capture Management (ACM) algorithm is a Medtronic EnPulse pacemaker (PM) feature that uses two algorithms: atrioventricular conduction (AVC) (atrial pacing and spontaneous AVC) and atrial chamber reset (ACR) [intrinsic atrial activity with atrioventricular block (AVB)]. For this prospective, non-randomized study, ACM automatically measured and recorded thresholds every 4 h. Data are reported as median (range) or mean +/- SD. In 2004-05, 14 consecutive patients (11 males, 79%), aged 12 years (1 day-24 years) received an EnPulse DDD/R PM for AVB (eight patients, 57%) or sinus node dysfunction. A new pacing system was implanted in eight patients (57%) and a replaced PM in six patients. Epicardial leads were implanted in 10 patients (71%). The follow-up duration is 11 (1-18) months: 9742 threshold measurements were attempted (6328 AVC, 3414 ACR), of which 3797 (39%) were successful (1807 AVC, 29%, 1990 ACR, 58%) in 11 (79%) patients. Three infants had no successful measurements. Measurement success was 42 +/- 34% (AVC 27 +/- 39%, ACR 41 +/- 29%). Higher thresholds were found between 00.00 and 12.00 a.m. and lower between 12.00 and 20.00.

Conclusion: Young patients show a circadian variability of atrial threshold with higher thresholds between 00.00 and 12.00.
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http://dx.doi.org/10.1093/europace/eum303DOI Listing
February 2008

Successful radiofrequency ablation of atrial tachycardias in surgically repaired Ebstein's anomaly using the Carto XP system and the QwikStar catheter.

J Cardiovasc Med (Hagerstown) 2007 Jun;8(6):459-62

Paediatric Cardiology Department, Bambino Gesù Hospital, Rome, Italy.

We describe the case of a child with three different atrial tachyarrhythmias originating from the right atrium, in whom a limited modified maze procedure was performed during surgical repair of an Ebstein's anomaly. Successful radiofrequency transcatheter ablation of all atrial tachyarrhythmias, one re-entrant and two focal, was obtained using the Carto XP EP three-dimensional navigation and ablation system, the new QwikMap software technology and the new mapping/ablation QwikStar multipolar catheter. No conventional mapping was used in addition to the three-dimensional system. Total procedural time was about 3 h and fluoroscopy time was 40 min. There were neither recurrences of the tachycardias nor complications during the follow-up (15 months).
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http://dx.doi.org/10.2459/01.JCM.0000269711.11059.3bDOI Listing
June 2007

Single-centre experience on endocardial and epicardial pacemaker system function in neonates and infants.

Europace 2007 Jun 24;9(6):426-31. Epub 2007 Apr 24.

Department of Pediatric Cardiology, Ospedale Bambino Gesù, IRCCS, Piazza S. Onofrio 4, 00165 Roma, Italy.

Aims: Endocardial (ENDO) or epicardial (EPI) pacing systems are implanted in infants but it remains unclear which system should be preferred.

Methods And Results: We evaluated the results of children
Conclusions: Single-lead, VVIR ENDO pacing had higher efficiency and safety than EPI, and it might be the best choice for PM implantation in infants. However, because of small patient numbers and lack of longer FU, these findings should be treated with caution.
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http://dx.doi.org/10.1093/europace/eum043DOI Listing
June 2007

Ventricular pacing threshold variations in the young.

Pacing Clin Electrophysiol 2007 Feb;30(2):175-81

Pediatric Cardiology Department, Ospedale Bambino Gesù, Roma, Italy.

Ventricular Capture Management (VCM) is a Medtronic Kappa pacemakers (PM) feature that automatically measures pacing threshold through detection of the evoked response after a pacing stimulus. The aim of this study was to evaluate the range of variation of ventricular pacing threshold in pediatric patients with endocardial and epicardial pacing leads. Thirty-one patients (median age 6.5 years) were implanted with a Kappa 901 PM for atrioventricular block or sinus node dysfunction. Congenital heart defects (CHD) were present in 58% of patients. Ventricular leads were epicardial in 52% of patients. VCM was programmed to automatically measure threshold every 2 hours. In a median follow-up of 12 months, 27,110 threshold measurements, 72% of which were successful, have been taken in 94% of patients. Measurement success was 99% in the endocardial leads group (age at implantation 12 +/- 6 years) and 31% in epicardial leads (age 4 +/- 5 years) (P < 0.05). Main reasons for unsuccessful measurements were high heart rate and, in a patient with an endocardial lead, competition with intrinsic rhythm. Undersensing or oversensing of the evoked responses was not detected. In all successful VCM measurements, epicardial pacing and CHD contributed to stability of thresholds (multivariate analysis). Pacing threshold showed specific circadian patterns: higher thresholds were found between 00.00 and 06.00 a.m., but the variation was low, 0.03 +/- 0.01 V. In conclusion, children and young patients show stable ventricular thresholds, especially in presence of CHD, and epicardial leads are at least as stable as endocardial leads. Ventricular pacing threshold showed a circadian variability similar to that described in adults, that does not seem to influence VCM functioning and PM programming.
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http://dx.doi.org/10.1111/j.1540-8159.2007.00646.xDOI Listing
February 2007

Closed loop stimulation improves ejection fraction in pediatric patients with pacemaker and ventricular dysfunction.

Pacing Clin Electrophysiol 2007 Jan;30(1):33-7

Cardiology Division, Bambin Gesù Hospital, Rome, Italy.

Background: The aim of this prospective study was to evaluate the effect of the closed loop stimulation (CLS) on the ejection fraction in pediatric patients, affected by complete atrioventricular block (CAVB) or CAVB and sinus node dysfunction (SND), with a previously implanted pacemaker (PM) and ventricular dysfunction. The role of electrical therapy in the treatment of pediatric patients with congenital atrioventricular (AV) blocks has been shown. Conventional right ventricular pacing seems to affect ventricular function. Up to now, the feasibility and the long-term results of biventricular pacing in pediatric patients were not entirely clear.

Methods: In eight pediatric patients with a previously implanted single or dual chamber PM, ventricular dysfunction, and CAVB or SND and CAVB, a dual chamber PM INOS(2+)-CLS (Biotronik GmbH, Berlin, Germany) was implanted. The effect of the physiological modulation of CLS pacing mode on the ejection fraction was evaluated by Echo-Doppler examination. Measurements were performed before the substitution of the old PM and for up to 2 years of follow-up.

Results: All patients showed correct electrical parameters at implantation and during follow-up. The mean value of the ejection fraction measured before the replacement of the old PM was 36 +/- 7%, while after 2 years it was 47 +/- 1% (P < 0.003). No patient showed any worsening of the ejection fraction, while only one showed no improvement.

Conclusions: DDD-CLS pacing seems to improve ventricular function in pediatric patients with CAVB and/SND in spite of the use of the apical right conventional stimulation.
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http://dx.doi.org/10.1111/j.1540-8159.2007.00576.xDOI Listing
January 2007

Lengthier cryoablation and a bonus cryoapplication is associated with improved efficacy for cryothermal catheter ablation of supraventricular tachycardias in children.

J Interv Card Electrophysiol 2006 Sep 10;16(3):191-8. Epub 2006 Oct 10.

Department of Pediatric Cardiology, Bambino Gesù Hospital, Rome, Italy.

Introduction: Cryoablation is an effective treatment for children with supraventricular tachycardias (SVT). The present study documents the effect of two different cryoablation protocols on acute and chronic success rates.

Methods And Results: Fifty-three consecutive patients (age range, 5-20 years) were treated; patients 1 to 17 were treated by a standard ablation protocol and patients 18 to 53 were treated by a modified ablation protocol that required lengthier cryoablations plus delivery of a bonus cryoapplication to consolidate the acutely successful irreversible lesion created at intervention. Electrophysiological study (EPS) was performed with diagnostic catheters and cryoablations were performed with a 7FR 4 mm tip catheter (CryoCath Technologies). Acute endpoints for non-inducibility of atrioventricular nodal re-entrant tachycardia (AVNRT) by programmed atrial stimulation at baseline or during isoproterenol performed 30 min post procedure, as well as non-inducibility and conduction block over the accessory pathway (AP). The chronic endpoint was arrhythmia recurrence post intervention. No permanent cryo-related complications or adverse outcomes were reported. Acute success rates for patients 1 to 17 and 18 to 53 were 88 and 100%, respectively. The cumulative percentage of patients without arrhythmia recurrence at 12 month follow-up was significantly different at 73 and 90%, respectively.

Conclusions: Lengthier cryoablation delivery, approximating 7 min per cryoablation, increases the acute success rate at intervention. Moreover, these lengthier cryoablation deliveries plus a bonus cryoapplication to consolidate the acutely successful irreversible lesion created at intervention may also significantly improve the chronic success rate, while also maintaining an excellent safety profile for cryoablation treatment of children with SVT such as AVNRT and AP located near the AV junction.
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http://dx.doi.org/10.1007/s10840-006-9028-2DOI Listing
September 2006

Atrioventricular nodal reentrant tachycardia in children.

Pediatr Cardiol 2006 Jul-Aug;27(4):454-9. Epub 2006 Jul 11.

Department of Pediatric Cardiology, Bambino Gesù Hospital, P.zza Sant'Onofiro, 400165 Rome, Italy.

The purpose of this study was to identify the clinical and electrophysiological characteristics of children with atrioventricular reentry tachycardia (AVNRT) and to define the prognosis and the treatment strategy. Sixty-two children (28 males and 34 females mean age, 10.2 +/- 3.2 years) with AVNRT ("slow-fast" type) were included in the study. Patients were divided into two groups: 47 patients with severe symptoms (group A) and 15 with mild symptoms (group B). The severity of the symptoms was not related to the electrophysiological parameters. Females were more symptomatic than males. Patients in group B did not receive any treatment (except 1 because of parents' choice) nor did they develop symptoms, and 5 patients had resolution of palpitations. Forty-one of 46 patients in group A were successfully treated with medical therapy as initial treatment. Thirty-one patients in group A underwent slow pathway ablation. There were late recurrences of AVNRT in 6 patients. Typical AVNRT in young patients does not appear to be life threatening. Patients with mild or no symptoms do well without therapy. Medical therapy and slow pathway ablation appear to be effective in the more symptomatic patients. Age and electrophysiological variables are not related to the symptoms or response to treatment. Females with AVNRT are more symptomatic and more likely to present with syncope.
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http://dx.doi.org/10.1007/s00246-006-1279-2DOI Listing
February 2007

Twenty years of paediatric cardiac pacing: 515 pacemakers and 480 leads implanted in 292 patients.

Europace 2006 Jul;8(7):530-6

Aritmologia, Dipartimento Medico-Chirurgico di Cardiologia Pediatrica, Ospedale Pediatrico Bambino Gesù, Piazza S. Onofrio 4, 00165 Roma, Italia.

Aims: The aim of this study was to evaluate long-term outcome of pacemakers (PMs) in paediatric patients.

Methods And Results: Patients' data were retrospectively reviewed. We recorded the techniques and systems used, any complication, and outcome. Endocardial leads were inserted by transcutaneous puncture of subclavian vein and fixed with a non-absorbable ligature, and epicardial leads by standard surgical technique. Lead survival was calculated and plotted with the product limit method of Kaplan-Meier. Between 1982 and 2002, 292 patients, aged 8+/-7 years (range 1 day-18 years), underwent PM implantation: the first PM had endocardial leads in 165 patients and epicardial in 127 patients. Structural heart disease (HD) was present in 239 patients. Follow-up was 5+/-4 (range 0.1-18) years. There were no pacing-related deaths. In total, 211 endocardial implantation procedures with 90 atrial and 165 ventricular leads and 145 epicardial procedures with 103 atrial and 123 ventricular leads were performed. Early (<3 months) complications: haemothorax occurred in 3.5% of endocardial leads and dislodgement was not significantly different for atrial and ventricular endocardial leads. Late complications: 63 leads failed (48 epicardial), with the worst outcome for conventional epicardial leads (31 vs. 9% endocardial, P<0.05; steroid eluting 8% epicardial vs. 5% endocardial, P=NS). Endocardial atrial leads failed (7%) in operated HD and ventricular leads failed (6%) after body growth, without difference in estimated mean survival time (11 years). Early and late PM infection/erosion was approximately 2% in all patients.

Conclusion: Pacing in children shows good results, but complications are frequent and related to leads. Endocardial pacing showed better long-term outcome.
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http://dx.doi.org/10.1093/europace/eul062DOI Listing
July 2006

Long term management of atrial arrhythmias in young patients with sick sinus syndrome undergoing early operation to correct congenital heart disease.

Europace 2006 Jul;8(7):488-94

Department of Pediatric Cardiology and Cardiosurgery, Bambino Gesù Pediatric Hospital, Rome, Italy.

Aims: The objective of our study was to evaluate the clinical outcome of patients with operated congenital heart disease (CHD), post-operative sinus node dysfunction and atrial tachyarrhythmias (AT) who had a new generation of DDDRP pacemakers (Model AT501, Medtronic Inc., MN, USA) able to deliver preventive atrial pacing and antitachycardia pacing (ATP) therapies.

Methods And Results: Fifteen CHD patients (mean age 17+/-9 years, eight after Mustard operation, five after extracardiac Fontan operation and two after atrial septum repair) received a dual-chamber pacemaker with transvenous (eight patients) or epicardial leads (seven patients). In the year before implantation, all patients had symptomatic AT (palpitations), eight patients required hospitalization and five required electrical cardioversion. Pacing prevention algorithms were enabled in all patients, and ATP therapies in six patients. During a mean follow-up of 30 months (range 24-44), three patients (two Fontan, one Mustard) died of CHF, whereas AT required hospitalization in three patients (two Fontan, one atrial septum repair). Only seven patients had symptomatic AT. One hundred and twenty-five AT episodes were treated by ATP in three patients, with an overall termination efficacy of 43.2%. In one patient, atrial lead noise induced inappropriate AT detection that resulted in ATP delivery. Several AT episodes were not treated owing to their very short duration, atrial undersensing, or 1:1 atrioventricular conduction.

Conclusions: Our experience with antitachycardia pacemakers in CHD patients with post-operative sick sinus syndrome after biventricular correction or palliation shows that these devices are safe and that atrial pacing may play a role in AT prevention and treatment.
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http://dx.doi.org/10.1093/europace/eul069DOI Listing
July 2006

Ventricular capture management in pediatric pacing: efficacy and safety.

Ital Heart J 2005 Sep;6(9):751-6

Cardiac Arrhythmias Service, Bambino Gesi Pediatric Hospital, Rome, Italy.

Background: The Ventricular Capture Management (VCM) of Medtronic Kappa 700 series pacemakers (PM) performs automatic threshold detection and optimization of pacing output that may enhance generator longevity. We evaluated efficacy and safety of this algorithm in children.

Methods: The study was prospective, non-randomized, involving 50 consecutive patients (mean age 5.6 +/- 6.6 years, median 4 years), enrolled at first PM implant. VCM was active from the implant, with nominal values of safety margin, minimum adapted pulse amplitude and width. Leads were endocardial and epicardial, all unipolar. Thresholds and pacing outputs were registered with telemetric PM interrogation. Endocardial and epicardial thresholds and outputs were also compared. Follow-up duration was 27 +/- 13 months (range 6-49 months).

Results: A significant reduction in pulse amplitude was evident since the sixth month. Thresholds and outputs were lower in endocardial than in epicardial pacing. A false negative capture detection occurred during the "acute phase" in 3 patients (6.0%), with incorrect automatic output increase to 5 V/1 ms. After this phase, the problem was still detected in 2 patients (4.0%). VCM correctly identified threshold increases in 2 patients (1%). No pacing defect was documented. VCM was not performed in 4 infants (8.0%) for pacing rate > or = 100 b/min.

Conclusions: VCM function is safe and effective in reducing pacing output in pediatric patients; this may increase PM longevity. Epicardial pacing shows higher thresholds and outputs than endocardial pacing.
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September 2005