bluuebunny/crossref_metadata_2025_split huggingface dataset:
P963Coronary orbital atherectomy manufacturers and user facility device experience (MAUDE) database: a 5-year analysis of real-world complications
Authors: Saleh M , Ahsan M J , Lateef N , Shokr M , Badran H , Hassanin M , Aboeata A 
Published: October 2019

Abstract

Background
Coronary Orbital Atherectomy System was approved by the United States FDA (food and Drug Administration) on October 21st, 2013. The initial safety data were published in the ORBIT I trial.

Purpose
Evaluation of the reported real-life complications related to utilization of orbital coronary atherectomy system since its approval in the United States using the online FDA database.

Methods
The Manufacturer and User facility Device Experience (MAUDE) database was queried for all complication reports involving the orbital atherectomy (OA) “Diamondback 360 coronary orbital atherectomy system” from 1/1/2013 through 12/31/2018. All reports were searched for complications; mortality, perforation, dissections, device fragmentation, and the need for surgical intervention among reported procedures. Duplicate entries and data with no reporting on final procedure outcome were excluded.

Results
Over the allocated interval519 reports were identified. Seven reports were excluded (according to exclusion criteria).
Over the period of slightly more than five years, coronary perforation was the most commonly reported complication mounting to 44.14% of all the reports (226 reports). Device fragmentation was reported in 18.94% of the reports (97 reports). Surgery was needed to retrieve device fragments in 13 cases (13.4% of all device fragmentation reports). Coronary dissection represented 16.21% of the reports (83 reports) and total surgical interventions were needed in 14.25% of the cases (73 reports). Finally, total reported deaths were 121 cases (23.63% of the total reports).
Year 2013 2014 2015 2016 2017 2018 Number of reported complications 4 28 46 81 113 247
Percentage of reported complications

Discussion
The current analysis, representing data from real world reported complications to the FDA over a period of 5 years, shows that the most common reported complication during coronary orbital atherectomy was coronary perforations, followed by device breakings and fragmentation (which necessitated surgical intervention in almost 13.4% of those device fragmentation cases reported). It is hard to compare these data with published safety trials since the FDA database is involved in reporting complications and not total number of procedures. However the most striking complication involved device fragmentation, which was not seen or reported among the pivotal trials evaluating device safety. The current analysis may shed some light on a non reported complication among patients undergoing orbital atherectomy which might represent a gap between the device performance in real world as opposed to a well-designed study world.
P972A subgroup analysis from the RAIN-CARDIOGROUP VII study: incidence of adverse events after DAPT cessation in patients treated with ultrathin stents in ULM or coronary bifurcations
Authors: Abdirashid M , D'Ascenzo F , Helft G , Boccuzzi G , Capodanno D , Giustetto C , Muscoli S , Wojakowski W , Wanha W , Protasiewicz M , Smolka G , Huczek Z , Kuliczowki W , Chieffo A , Rinaldi M 
Published: October 2019

Abstract

Introduction
Incidence and predictors of adverse events after dual antiplatelet therapy (DAPT) cessation in patients treated with ultrathin stents in unprotected left main (ULM) or coronary bifurcation remain undefined.

Methods
All consecutive patients presenting with a critical lesion of an ULM or a lesion involving a main coronary bifurcation and treated with very thin strut stents were included. MACE (a composite end point of cardiovascular death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis (ST) was the primary endpoint, while target vessel revascularization (TVR) was the secondary endpoint. Moreover, type and occurrence of ST and occurrence of ST, CV death and MI during DAPT or after DAPT discontinuation were also evaluated. All analyses were performed according to length of DAPT dividing the patients in 3 groups: short DAPT (3-months), intermediate DAPT (3–12 months) and long DAPT (12-months).

Results
117 patients were discharged with an indication for DAPT≤3 months (median 1:1–2.5), 200 for DAPT between 3 and 12 months (median 8:7–10) and 1958 with 12 months DAPT. After 12.8 months (8–20), MACE was significantly higher in the 3-month group compared to 3–12 and 12-month groups (9.4% vs. 4.0% vs. 7.2%, p≤0.001), mainly driven by MI (4.4% vs. 1.5% vs. 3%, p≤0.001) and overall ST (4.3% vs. 1.5% vs. 1.8%, p≤0.001). ST post DAPT cessation were comparable (1.7% vs. 0% vs. 0.7%, p=0.42) with a median time to ST post DAPT discontinuation of 1.67 months (0.48–4.7). At multivariate analysis, DAPT of 12-months compared to 3-months reduces the risk of overall ST (OR 0.103: 0.019–0.0563, 95% CI) while only a trend was noted for DAPT between 3 and 12 months (OR 0.61: 0.186–2.005, 95% CI). When analysed by stent strategy a 2-stent strategy predicted ST post DAPT cessation (OR 3.241: 1.048–10.026, 95% CI), which was reduced by use of FKB (OR 0.101:0.01–0.872, 95% CI).

Conclusion
Even stents with very thin strut when implanted in real-life ULM or coronary bifurcation patients discharged with short DAPT have a relevant risk of ST, which remains high although not significant after DAPT cessation. The correct identification before PCI of the more fragile patients who may receive a shorter DAPT regimen could help identify the safest PCI technique: provisional stenting and use of final kissing balloon (FKB) are the safest options.
P981Predictor factors and the prognostic role of persistent pulmonary veins isolation in patients with arrhythmia recurrence necessitating a second ablation procedure
Authors: Vevecka A , Schwab C , Forkmann M , Fischer T H , Butz S , Tuschner O , Mahnkopf C H , Brachmann J , Busch S 
Published: October 2019

Abstract

Aims
Pulmonary vein isolation (PVI) is the treatment of choice in patients (pts) with symptomatic atrial fibrillation. Durable pulmonary veins isolation (PVI) seems to be associated with a lower risk of AF recurrence, but the predictor factors of persistent PVI are still uncertain. We aimed to determinate the predictor factors and the prognostic role of persistent pulmonary veins isolation in pts with arrhythmia recurrence necessitating a second ablation procedure.

Methods and results
Our Study included 102 pts (65.7% male, 65±8 years old, 75.5% persistent AF) with arrhythmia recurrence, whom underwent a Redo-PVI between October 2016 and Mars 2018. Patients were divided into two groups regarding the persistence of PVI. Group 1 included 20 pts with persistent PVI and Group 2 included 82 pts with reconnection of at least one PV. The clinical profile, ablation data and three months arrhythmia recurrence were analyzed.
There were no statistical differences in terms of clinical profile between the two groups of pts (age; p=0.513, gender; p=0.299, BMI; p=0.077, diabetes mellitus; p=0.621, coronary artery disease; p=0.787; arterial hypertension; p=0.732; left ventricle ejection fraction; p=0.323 and left atrial diameter; p=0.5). Patients in group 1 presented more often with atrial tachycardia compared to group 2 Patients (30% versus 7.3%; p=0.014). Regarding the ablation data, there were no differences between the two groups in terms of procedure time (p=0.710) but the ablation time was longer in group 2 patients (29.1±13.7 versus 20.8±10.5 min. p=0.031). Low voltage areas (LVA) acquired by bipolar electroanatomical mapping were more often and diffuse in group 1 patients (70% versus 40.3%; p=0.050). The three months arrhythmia recurrence after Redo-Ablation was the same between the two groups (p=1.000).

Conclusion
The type of arrhythmia recurrence and low voltage areas are predictor factors of persistent pulmonary veins isolation in patients with arrhythmia recurrence necessitating a second ablation procedure. This fact can help in planning the second ablation procedure. Persistent PVI seems to have no prognostic role regarding the three months arrhythmia recurrence after Redo-Ablation.
P984Residual gaps in the ablation line and requirement for carina ablation during contact force-guided radiofrequency pulmonary vein isolation: determinants and prognostic implications
Authors: Mulder M J , Kemme M J B , Gotte M J W , Hauer H A , Tahapary G J M , Van Rossum A C , Allaart C P 
Published: October 2019

Abstract

Background
Pulmonary vein isolation (PVI) is not always achieved after initial encircling of the pulmonary veins (PVs). Additional touch-up lesions are frequently required to close residual gaps, which may occur both in the initial ablation line and on the intervenous carina.

Purpose
We aimed to identify determinants and prognostic implications of residual gaps during index radiofrequency PVI.

Methods
Two hundred fourteen AF (atrial fibrillation) patients (57% paroxysmal, 61% male, mean age 62±9 years) undergoing contact force-guided PVI were studied. Residual gaps after initial encircling of the PVs were targeted for additional ablation and were classified as either gap ablation in the initial WACA (wide-area circumferential ablation) circle or carina ablation, depending on the site of earliest activation. After a waiting period of at least 30 minutes, persistence of PVI was tested through administration of 9–18 mg intravenous adenosine. Pre-procedural cardiac computed tomography imaging was used to assess left atrial and PV anatomy. Carina width was defined as the distance between ipsilateral superior and inferior PV ostia. Ablation procedures were analyzed to define the perimeter of the WACA circle.

Results
One hundred thirty-three patients (62%) required additional ablation lesions beyond the initial WACA circles to achieve complete PVI. Gap ablation was required in the left WACA circle in 34 patients (16%) and in the right WACA circle in 49 patients (23%). Left and right carina ablation were required in 50 (23%) and 83 (39%) patients, respectively. Multivariate analyses identified carina width and perimeter of the WACA circle as independent predictors of requirement for ipsilateral carina ablation, whereas paroxysmal AF and the perimeter of the WACA circle were associated with requirement of gap ablation in the initial WACA circle. Recurrence of atrial tachyarrhythmias was documented in 73 patients (34%) at 12 months follow-up. Kaplan–Meier survival analyses demonstrated a significantly higher rate of recurrence in patients with one or more residual gaps in the ablation line (43% vs. 30%, p=0.019, figure A), whereas no significant difference between patients with and without requirement of carina ablation was found (38% and 29%, respectively; p=0.111, figure B).
Kaplan-Meier survival analyses

Conclusion
Residual gaps in the initial WACA circle were associated with increased AF recurrence rate after PVI, whereas residual gaps on the intervenous carina had no statistically significant impact on AF recurrence. Consequently, gaps occurring in the ablation line and gaps on the intervenous carina may represent different mechanisms and may have different prognostic implications.
P988Implantable cardioverter defibrillators in patients with electrical heart disease and hypertrophic cardiomyopathy - data from the German device Registry
Authors: Frommeyer G , Reinke F , Andresen D , Klemann T , Spitzer S G , Jehle J , Brachmann J , Stellbrink C , Hochadel M , Senges J , Eckardt L 
Published: October 2019

Abstract

Background
Implantable cardioverter- defibrillator (ICD) therapy is established for prevention of sudden cardiac death (SCD) in different entities. However, data from large patient cohorts on patients with electrical heart disease of hypertrophic cardiomyopathy (HCM) is rare. Therefore, we investigated these patients by analysing registry data from a multi-center “real-life” registry.

Methods
The German Device Registry (DEVICE) is a nationwide, prospective registry with one-year follow-up investigating 5450 patients receiving device implantations in 50 German centres. The present analysis of DEVICE focussed on patients with electrical heart disease or HCM who received an ICD for primary or secondary prevention.

Results
174 patients with HCM and 112 patients with electrical heart disease were compared with 5164 other ICD patients. Median follow-up was 17.0 months. Patients in the control group were significantly older. Of note, overall mortality after one year was 1.8% in HCM patients, 6.6% in patients with electrical heart disease and 7.3% in the control group. Patients in the control group presented significantly more severe comorbidities. In contrast to HCM patients and the control group where primary prevention was the major indication for ICD implantation 77.5% of patients with electrical heart disease received an ICD for secondary prevention. The number of surgical revisions was higher in patients with electrical heart disease.

Conclusion
Data from the present registry display a surprisingly high mortality in patients with electrical heart disease equivalent to the control group. A high proportion of patients who received an ICD for secondary prevention may be regarded as a major determinant for these results while severe comorbidities such as diabetes, hypertension and renal failure are major determinants for mortality in the control cohort.
P990Assessment of clinical risk factors for all-cause mortality among hypertrophic cardiomyopathy patients with ICDs
Authors: Mielczarek S , Syska P , Lewandowski M , Przybylski A , Sterlinski M , Maciag A , Zajac D , Kowalik I , Pytkowski M , Szwed H 
Published: October 2019

Abstract

Introduction
According to the literature, the annual mortality rate of hypertrophic cardiomyopathy (HCM) patients is estimated to 1–2%. Sudden cardiac death (SCD), heart failure and thromboembolism are the main causes of death among this population. Patients at high risk for SCD, identified using HCM risk score, are qualified for ICD implantation. Unfortunately for clinicians, there is no validated model or statistical tool for assessment of the risk of mortality within the HCM patients with ICDs.

Purpose
The aim of this study was to determine the main risk factors of all- cause mortality in HCM patients with ICDs.

Methods
The long-term follow-up of group of 104 consecutive patients with HCM, who had the ICD implanted between 1996 and 2006 in tertiary reference clinical unit was performed. Twenty patients who died during observation were the subject of the current analysis. ICD was implanted for primary (n=16) and secondary (n=4) prevention of SCD within this subpopulation. Analysis were performed for mentioned below potential risk factors: age at the time of implantation, syncopes, family history of SCD, atrial fibrillation/supraventricular tachycardia, decreased left ventricular ejection fraction (LVEF), non-sustained ventricular tachycardia (nsVT), maximum left ventricular wall thickness, abnormal exercise blood pressure response, left ventricular outflow tract obstruction.

Results
The average time of survival since ICD implantation was 8,5±4,6 years. Decreased LVEF (Wald chi2 4,57; p=0,033), secondary prevention (Wald chi2 8,57; p=0,003), family history of SCD (Wald chi2 4,93; p=0,026) and episodes of nsVT (Wald chi2 3,49; p=0,062) are the clinical risk factors that significantly affect the time of survival. The probability of death, expressed as Hazard Ratio, was 27-fold higher in secondary prevention group (HR=27,18), almost 10-fold higher in patients with positive family history of SCD (HR=9,74) and 3,7-fold higher when nsVT was detected. The cause of death was established in 16/20 patients. In 15 cases, these were deaths from cardiovascular causes: end-stage heart failure (8), complications of heart transplantation or circulatory support (4), SCD (1) and other cardiovascular (2).

Conclusion
Secondary prevention, positive family history of SCD, nsVT and decreased LVEF seem to be the most significant risk factors associated with all- cause mortality in HCM patients with ICDs. Despite the ICD implantation, subpopulation studied had poor prognosis with high incidence of progression to end-stage heart failure. Further studies to create validated model for assessment of death risk in long-term observation of patients with HCM after ICD implantation are required.
P994Association of late gadolinium enhancement with prognosis and sudden cardiac death risk in non-ischemic dilated cardiomyopathy
Authors: Rodriguez Sanchez I , Onaindia J J , Velasco S , Aguirre U , Capelastegui A , Astigarraga E , Gomez V , Urkullu A , Ullate A , Benegas A , Florido J , Cacicedo A 
Published: October 2019

Abstract

Objectives
to evaluate the association between late gadolinium enhancement (LGE) on cardiac magnetic resonance imaging (cMRI) and prognosis in patients with non-ischemic dilated cardiomyopathy (NIDM).

Background
Risk stratification in NIDM needs to be improved.

Methods
A total of 210 patients with NIDM and cMRI from 2005 to 2018 were included in our population. Outcomes were retrospectively assessed by medical records. The pattern of LGE was classified as midwall, subepicardial, or both patterns. Primary endpoint was sudden cardiac death (SCD) and aborted SCD. Secondary endpoints were global mortality and a composite endpoint of cardiovascular mortality and heart failure hospitalization. Demographic and clinical parameters were also evaluated. Patients with LGE (LGE+) were more likely to be male (80,6% vs 66,7%, p=0,03). No significant differences were observed between LGE+ and LGE− patients in comorbidities, NYHA class, left ventricular ejection fraction (LVEF), left bundle branch block or neurohormonal treatment.

Results
Of 210 patients (71,4% men, median age 59,8 years) with a median follow up of 5,6 years (3,24–8,15), 72 patients (34,3%) had non ischemic LGE (LGE+). Mean LVEF was 34%.
SCD or aborted SCD occurred in 11 patients (5,2%). 6 patients (9,5%) with LGE+ reached the primary endpoint vs 5 (4,07%) of LGE− patients (p=0,19).
The adjusted OR for the presence of LGE in the composite endpoint (cardiovascular mortality and heart failure hospitalization) was 2,45, confidence interval (CI): 1,16–5,17, (p=0,02).
LGE presence was not associated with global mortality.
The subepicardial pattern of LGE was associated with SCD and aborted SCD: 3 out of 11 patients (27, 1%) with subepicardial pattern of LGE suffered from SCD or aborted SCD (p=0,02).

Conclusions
In our cohort of 210 patients with NIDM, LGE presence was not associated with SCD and aborted SCD, probably because of low event rate in a relatively small population. However, LGE presence was associated with the composite endpoint of cardiovascular mortality and heart failure hospitalization. The subepicardial pattern of LGE identified patients at high risk of SCD and aborted SCD.
P1001Safety and effectiveness of transcatheter leak occlusion with detachable coils following left atrial appendage closure
Authors: Della Rocca D G , Horton R P , Gasperetti A , Di Biase L , Mohanty S , Natale V N , Trivedi C , Bassiouny M , Al-Ahmad A , Gianni C , Burkhardt J D , Gallinghouse G J , Romero J , Sanchez J , Natale A 
Published: October 2019

Abstract

Introduction
Incomplete left atrial appendage (LAA) closure resulting in residual, significant leak is common after LAA exclusion procedures, potentially hindering an effective thromboembolic (TE) prevention. Detachable coils have found a wide range of applications for transcatheter vascular occlusion/embolization procedures.

Purpose
We report for the first time the feasibility and efficacy of transcatheter leak closure with detachable coils in patients with incomplete LAA closure.

Methods
Thirtyconsecutive high TE-riskpatients with a clinically-relevant residual leak (mean age: 72±9 years; 73.3% males; CHA2DS2-VASc: 4.3±1.5; HAS-BLED: 3.4±1.1)underwent percutaneous closure of the LAA patency via detachable coils (Interlock-35 Fibered IDC Occlusion System, Boston Scientific Inc.; Concerto Helix Detachable Coil System, ev3 Endovascular Inc; Azur Embolization System, Terumo Interventional Systems). Trans-oesophageal echocardiography (TEE) was performed at 45±15 days post-procedure to assess for residual LAA patency.

Results
LAA closure had been previously attempted with a Watchman device in 25 patients, an Amulet in 2 and a LARIAT in 3. At pre-procedural TEE, a moderate/severe leak was documented in 28 (93.3%) patients, a mild one in 2 (6.7%) patients.
Procedure andfluoroscopy times were 73±40min and 21±15min, respectively; the mean volume of iodinated contrast medium was 80±48mL. Overall, 114 coils were released into patents' LAA (median: 3 coils/patient; IQR: 2–4). Coil deployment was successful in 98.2% of cases (112/114).
The overall complication-free rate was 93.3% (28/30). There were no instances of vascular injury, TE events, device dislodgment. There was 1 major adverse device-related event in an 87-yo male, who developed pericardial tamponade requiring a pericardial window. A small pericardial effusion without hemodynamic compromise was noted in a 78-yo woman and treated conservatively.
Follow-up TEE in all patients revealed complete LAA sealing or a minimal-mild leak in 28 cases (93.3%; 22 with no residual leak, 6 with a minimal-mild residual one), and a moderate residual leak in 2 patients (6.7%).

Conclusions
Transcatheter LAA leak occlusion via detachable coils is a safe, effective and promising approach in high TE-risk patients with incomplete LAA closure.
P1005Origin, distribution and timing of the slow pathway potentials recorded inside the Kock's triangle in Avnrt patients through High-density Mapping
Authors: Segreti L , Lavalle C , Galeazzi M , Zingarini G , Bongiorni M G , Del Giorno G , Narducci M L , Russo M , Piro A , Pelargonio G , Carbone A , Piccolo F , Malacrida M , Pandozi C , Colivicchi F 
Published: October 2019

Abstract

Background
Atrial activation during typical atrioventricular nodal reentrant tachycardia (AVNRT) exhibits anatomic variability and spatially heterogeneous propagation inside the Kock's Triangle (KT). The mechanism of the reentrant circuit has not been elucidated yet.

Purpose
To evaluate signal characteristics and find out the origin, distribution, and timing of the slow pathway (SP) potentials recorded in the KT.

Methods
The 3-D KT geometry was created during both sinus rhythm (SR) and tachycardia (TR) from the basket mapping catheter IntellaMap Orion and the Rhythmia Mapping System (Boston Scientific). The KT was divided into 8 regions moving from an antero-septal to postero-septal areas and bounded by tricuspid annulus (TA) anteriorly and tendon of Todaro (TT) posteriorly. Each area was characterized in terms of distribution and timing of Jackman (JP) and Haissaguerre (HP) potentials and signal amplitude.

Results
20 consecutive successful SP ablation cases of AVNRT were included (mean RA acquired points = 6000±1100, 275±63 inside the KT; mean KT area=29±3mm2; mean mapping time=12±5 minutes). During SR, the site of earliest atrial activation within the KT was anterior in 80% of patients whereas a midseptal activation occurred less frequently (20%). The mid-septal regions bounded by TA anteriorly and TT posteriorly showed higher prevalence of JP as compared to antero-/mid-septal regions across TT both in SR and TR (77.4% vs 4.8% during SR, p<0.0001; 84.1% vs 0% during TR, p<0.0001, respectively). HPs seemed to have variable distribution across KT (50% of these potentials recorded in antero- to mid-septal regions across TT for SR, 52.3% for TR). The median signal voltage was 0.44 [0.2–0.9] mV during SR and 0.5 [0.22–0.895] mV during TR. The mid-septal region was the area of lowest voltage compared to other regions (0.2 [0.1–0.7] mV vs 0.5 [0.4–1.5] mV for SR, p<0.0001; 0.2 [0.15–0.6] mV vs 0.6 [0.4–1.5] mV for TR, p<0.0001, respectively).

Conclusion
JPs seem to be associated with low signal-amplitude areas whereas HPs seem to have variable distribution across KT. Although not perfectly known, the typical low-high-type double potential of JP might be therefore explained by wavefront collision in the lowest area of the KT.

Acknowledgement/Funding
None