Publications by authors named "Justin G L M Luermans"

29 Publications

  • Page 1 of 1

Innovations and paradigm shifts in atrial fibrillation ablation.

Europace 2021 Apr;23(Supplement_2):ii23-ii27

Department of Cardiology, University of Groningen, University Medical Center Groningen, P.O. Box 30.001, 9700 RB Groningen, The Netherlands.

Treatment of symptomatic atrial fibrillation has seen important changes in the past decades. Advancements have especially been made in the field of non-pharmacological treatment of this disease. Patients in whom a rhythm control strategy is chosen the place of catheter ablation has become more frontline therapy in the past years. The procedure itself has also seen changes in technologies that can be used, either using point-by-point radiofrequency or one of the single-shot techniques. One of the major limitations that remain is that re-do procedures are often necessary due to incomplete pulmonary vein isolation and/or atrial fibrillation being initiated by other mechanisms than pulmonary vein triggers. Therefore, there is further need for developing ablation tools that reproducibly isolate the pulmonary vein transmurally. Furthermore, addressing the underlying conditions before and after catheter ablation has been shown to be of great importance. In this review, we will give an overview of the evolution of catheter ablation, highlight the latest technologies and their future endeavours, and lifestyle modifications are being discussed as part of the catheter ablation strategy.
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http://dx.doi.org/10.1093/europace/euaa418DOI Listing
April 2021

A hybrid approach to complex arrhythmias.

Europace 2021 Apr;23(Supplement_2):ii28-ii33

Department of Cardiothoracic Surgery, Maastricht University Medical Center, Maastricht, the Netherlands.

Despite many years of research, the different aspects of the mechanism of atrial fibrillation (AF) are still incompletely understood. And although the latest guidelines recommend catheter ablation with pulmonary vein isolation as a rhythm control strategy, long-term results in persistent and long-standing persistent AF are suboptimal. Historically, a mechanistic-based patient-tailored approach for the treatment of AF was impossible because of the lack real-time mapping techniques and advanced ablation tools. Therefore, surgeons created lesion sets based upon the anatomy of both atria and the safety of the incisions made by the knife. These complex open-heart procedures had to be performed through a sternotomy on the arrested heart and where therefore not generally adopted. The use of controlled energy sources such as cryothermy and radiofrequency where the first step to make the creation of these lesions less complex. With the development and improvement of electrophysiology techniques and catheters, this invasive and solely anatomical approach could again be partially redesigned. Now less invasive, it prepared the way for collaboration between electrophysiologists working on the endocardial side of the heart and cardiac surgeons providing epicardial access. The introduction of video-assisted technology and hybrid procedures has further increased the possibilities of new successful therapies. Now more than 40 years since the beginning of this exciting maze of AF procedures and still working towards a less aggressive and more comprehensive approach we give an overview of the history of the different minimally invasive surgical solutions and of the hybrid approach.
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http://dx.doi.org/10.1093/europace/euab027DOI Listing
April 2021

Comparing Ventricular Synchrony in Left Bundle Branch and Left Ventricular Septal Pacing in Pacemaker Patients.

J Clin Med 2021 Feb 17;10(4). Epub 2021 Feb 17.

Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Centre + (MUMC+), 6229 HX Maastricht, The Netherlands.

Background: Left bundle branch area pacing (LBBAP) has recently been introduced as a novel physiological pacing strategy. Within LBBAP, distinction is made between left bundle branch pacing (LBBP) and left ventricular septal pacing (LVSP, no left bundle capture).

Objective: To investigate acute electrophysiological effects of LBBP and LVSP as compared to intrinsic ventricular conduction.

Methods: Fifty patients with normal cardiac function and pacemaker indication for bradycardia underwent LBBAP. Electrocardiography (ECG) characteristics were evaluated during pacing at various depths within the septum: starting at the right ventricular (RV) side of the septum: the last position with QS morphology, the first position with r' morphology, LVSP and-in patients where left bundle branch (LBB) capture was achieved-LBBP. From the ECG's QRS duration and QRS morphology in lead V1, the stimulus- left ventricular activation time left ventricular activation time (LVAT) interval were measured. After conversion of the ECG into vectorcardiogram (VCG) (Kors conversion matrix), QRS area and QRS vector in transverse plane (Azimuth) were determined.

Results: QRS area significantly decreased from 82 ± 29 µVs during RV septal pacing (RVSP) to 46 ± 12 µVs during LVSP. In the subgroup where LBB capture was achieved ( = 31), QRS area significantly decreased from 46 ± 17 µVs during LVSP to 38 ± 15 µVs during LBBP, while LVAT was not significantly different between LVSP and LBBP. In patients with normal ventricular activation and narrow QRS, QRS area during LBBP was not significantly different from that during intrinsic activation (37 ± 16 vs. 35 ± 19 µVs, respectively). The Azimuth significantly changed from RVSP (-46 ± 33°) to LVSP (19 ± 16°) and LBBP (-22 ± 14°). The Azimuth during both LVSP and LBBP were not significantly different from normal ventricular activation. QRS area and LVAT correlated moderately (Spearman's = 0.58).

Conclusions: ECG and VCG indices demonstrate that both LVSP and LBBP improve ventricular dyssynchrony considerably as compared to RVSP, to values close to normal ventricular activation. LBBP seems to result in a small, but significant, improvement in ventricular synchrony as compared to LVSP.
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http://dx.doi.org/10.3390/jcm10040822DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7923157PMC
February 2021

Risk Factors for Atrial Fibrillation Progression.

Card Electrophysiol Clin 2021 03 8;13(1):201-209. Epub 2021 Jan 8.

Department of Cardiology, CARIM School for Cardiovascular Diseases, Maastricht University Medical Center+, PO Box 5800, Maastricht 6202 AZ, The Netherlands. Electronic address:

Atrial fibrillation is a chronic, progressive condition that presents a major health burden. This review summarizes recent studies assessing atrial fibrillation progression and its associated risk factors, describes the mechanisms underlying atrial fibrillation progression, and discusses the clinical implications of the progressive nature of atrial fibrillation. Progression of atrial fibrillation burden, and clinical progression from paroxysmal to more advanced (persistent/permanent) forms is common, but progression rates are variable. Atrial fibrillation progression parallels progressive atrial remodeling induced by atrial fibrillation risk factors and atrial fibrillation itself, and is associated with worse clinical outcomes.
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http://dx.doi.org/10.1016/j.ccep.2020.10.011DOI Listing
March 2021

Long-term intermittent versus short continuous heart rhythm monitoring for the detection of atrial fibrillation recurrences after catheter ablation.

Int J Cardiol 2021 Apr 4;329:105-112. Epub 2021 Jan 4.

Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht, Maastricht, the Netherlands; Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address:

Background: The utility of long-term intermittent heart rhythm monitoring after atrial fibrillation (AF) ablation remains unclear. Therefore, we compared the efficacy and usability of long-term intermittent (AliveCor Kardia® (ACK)) versus short continuous (Holter) heart rhythm monitoring for the detection of AF recurrences after AF ablation and evaluated ACK accuracy to detect AF.

Methods: Patients were provided with Holter (for ≥24 h) simultaneously with an ACK (4 weeks) used three times a day and in case of symptoms. The primary endpoint was the difference in proportion of patients diagnosed with recurrent AF by ACK as compared to Holter monitoring. Secondary endpoints were the usability (System Usability Scale and a four-item questionnaire) of ACK and Holter monitoring; and the accuracy of the ACK algorithm for AF detection.

Results: Out of 126 post-ablation patients, 115 (91.3%; 35 females, median age 64.0 [58.0-68.0] years) transmitted overall 7838 ACK ECG recordings. ACK and Holter monitoring detected 29 (25.2%) and 17 (14.8%) patients with AF recurrences, respectively (p < 0.001). More than 2 weeks of ACK monitoring did not have additional diagnostic yield for detection of AF recurrences. Patients graded ACK higher than Holter monitoring and found ACK more convenient in daily usage than Holter (p < 0.001). Sensitivity and specificity of ACK for AF detection were 95.3% and 97.5%, respectively.

Conclusions: Long-term intermittent monitoring by ACK more effectively detects AF recurrences after AF ablation and has a higher patients' usability than short continuous Holter monitoring. ACK showed a high accuracy to detect AF.
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http://dx.doi.org/10.1016/j.ijcard.2020.12.077DOI Listing
April 2021

Cardiac Inflammation Impedes Response to Cardiac Resynchronization Therapy in Patients With Idiopathic Dilated Cardiomyopathy.

Circ Arrhythm Electrophysiol 2020 11 30;13(11):e008727. Epub 2020 Sep 30.

Cardiovascular Research Institute (CARIM), Departments of Cardiology (J.A.J.V., J.J.M., A.M.W.v.S., M.T.H.M.H., V.P.M.v.E., C.K., J.G.L.M.L., H.J.G.M.C., H.-P.B.-L.R., K.V., S.R.B.H., M.R.H.), Maastricht University Medical Center, the Netherlands.

Background: Cardiac resynchronization therapy (CRT) is an established therapy in patients with dilated cardiomyopathy (DCM) and conduction disorders. Still, one-third of the patients with DCM do not respond to CRT. This study aims to depict the underlying cardiac pathophysiological processes of nonresponse to CRT in patients with DCM using endomyocardial biopsies.

Methods: Within the Maastricht and Innsbruck registries of patients with DCM, 99 patients underwent endomyocardial biopsies before CRT implantation, with histological quantification of fibrosis and inflammation, where inflammation was defined as >14 infiltrating cells/mm. Echocardiographic left ventricular end-systolic volume reduction ≥15% after 6 months was defined as response to CRT. RNA was isolated from cardiac biopsies of a representative subset of responders and nonresponders.

Results: Sixty-seven patients responded (68%), whereas 32 (32%) did not respond to CRT. Cardiac inflammation before implantation was negatively associated with response to CRT (25% of responders, 47% of nonresponders; odds ratio 0.3 [0.12-0.76]; =0.01). Endomyocardial biopsies fibrosis did not relate to CRT response. Cardiac inflammation improved the robustness of prediction beyond well-known clinical predictors of CRT response (likelihood ratio test <0.001). Cardiac transcriptomic profiling of endomyocardial biopsies reveals a strong proinflammatory and profibrotic signature in the hearts of nonresponders compared with responders. In particular, , and were significantly higher expressed in the hearts of nonresponders.

Conclusions: Cardiac inflammation along with a transcriptomic profile of high expression of combined proinflammatory and profibrotic genes are associated with a poor response to CRT in patients with DCM.
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http://dx.doi.org/10.1161/CIRCEP.120.008727DOI Listing
November 2020

Temporal patterns and short-term progression of paroxysmal atrial fibrillation: data from RACE V.

Europace 2020 08;22(8):1162-1172

Department of Cardiology, University Medical Centre Groningen, University of Groningen, P.O. Box 30.001, 9700 RB Groningen, The Netherlands.

Aims: Atrial fibrillation (AF) often starts as a paroxysmal self-terminating arrhythmia. Limited information is available on AF patterns and episode duration of paroxysmal AF. In paroxysmal AF patients, we longitudinally studied the temporal AF patterns, the association with clinical characteristics, and prevalence of AF progression.

Methods And Results: In this interim analysis of the Reappraisal of AF: Interaction Between HyperCoagulability, Electrical Remodelling, and Vascular Destabilisation in the Progression of AF (RACE V) registry, 202 patients with paroxysmal AF were followed with continuous rhythm monitoring (implantable loop recorder or pacemaker) for 6 months. Mean age was 64 ± 9 years, 42% were women. Atrial fibrillation history was 2.1 (0.5-4.4) years, CHA2DS2-VASc 1.9 ± 1.3, 101 (50%) had hypertension, 69 (34%) heart failure. One-third had no AF during follow-up. Patients with long episodes (>12 hours) were often men with more comorbidities (heart failure, coronary artery disease, higher left ventricular mass). Patients with higher AF burden (>2.5%) were older with more comorbidities (worse renal function, higher calcium score, thicker intima media thickness). In 179 (89%) patients, 1-year rhythm follow-up was available. On a quarterly basis, average daily AF burden increased from 3.2% to 3.8%, 5.2%, and 6.1%. Compared to the first 6 months, 111 (62%) patients remained stable during the second 6 months, 39 (22%) showed progression to longer AF episodes, 8 (3%) developed persistent AF, and 29 (16%) patients showed AF regression.

Conclusions: In paroxysmal AF, temporal patterns differ suggesting that paroxysmal AF is not one entity. Atrial fibrillation burden is low and determined by number of comorbidities. Atrial fibrillation progression occurred in a substantial number.

Trial Registration Number: Clinicaltrials.gov identifier NCT02726698.
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http://dx.doi.org/10.1093/europace/euaa123DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7400474PMC
August 2020

Mechanical circulatory support for life-threatening arrhythmia: A systematic review.

Int J Cardiol 2020 06 19;308:42-49. Epub 2020 Mar 19.

Cardio-Thoracic Surgery Department, Heart and Vascular Centre, Maastricht University Medical Centre, Maastricht, The Netherlands; Cardiovascular Research Institute Maastricht (CARIM), Maastricht, The Netherlands.

Background: The use of temporary mechanical circulatory support (tMCS) during arrhythmia is increasing, although available evidence for this indication is limited, with significant gaps of knowledge regarding appropriate timing, management and configuration. This systematic review sought to analyze the use of tMCS in patients with life-threatening arrhythmia.

Methods: A systematic literature search identified 2529 references published until September 2019. Adult and pediatric patients diagnosed with all kind of life-threatening arrhythmia were included. tMCS was primarily compared to conventional non-tMCS therapies. Primary outcome measure was in-hospital or 30-day mortality.

Results: 19 non-randomized studies were selected, including 2465 adult and 82 pediatric patients. Primary outcome in tMCS patients varied widely (4-62%) with differences based on the use of prophylactic tMCS (4-21%) or rescue tMCS (58-62%). A substantial mortality benefit was observed among high-risk patients, as identified with PAINESD risk score or suffering from electrical storm and treated with prophylactic tMCS. During ablation procedures, tMCS patients showed higher rates of induced ventricular tachycardias (VTs), ablated VTs, VT termination and non-inducibility after ablation. Extracorporeal membrane oxygenation (ECMO) was applied in pediatric cases as hemodynamic protection for aggressive antiarrhythmic medical treatment with >80% survival.

Conclusions: Prophylactic tMCS is associated with improved survival as compared to rescue or no-tMCS in patients with life-threatening arrhythmia, and may be considered in patients with high PAINESD risk score or suffering from electrical storm. ECMO can be advised as rescue and support therapy in pediatric cases requiring aggressive antiarrhythmic medical treatment.
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http://dx.doi.org/10.1016/j.ijcard.2020.03.045DOI Listing
June 2020

Short-Term Hemodynamic and Electrophysiological Effects of Cardiac Resynchronization by Left Ventricular Septal Pacing.

J Am Coll Cardiol 2020 02;75(4):347-359

Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center (MUMC+), Maastricht, the Netherlands; Department of Cardiology, Radboud University Medical Centre (Radboudumc), Nijmegen, the Netherlands.

Background: Cardiac resynchronization therapy (CRT) is usually performed by biventricular (BiV) pacing. Previously, feasibility of transvenous implantation of a lead at the left ventricular (LV) endocardial side of the interventricular septum, referred to as LV septal (LVs) pacing, was demonstrated.

Objectives: The authors sought to compare the acute electrophysiological and hemodynamic effects of LVs with BiV and His bundle (HB) pacing in CRT patients.

Methods: Temporary LVs pacing (transaortic approach) alone or in combination with right ventricular (RV) (LVs+RV), BiV, and HB pacing was performed in 27 patients undergoing CRT implantation. Electrophysiological changes were assessed using electrocardiography (QRS duration), vectorcardiography (QRS area), and multielectrode body surface mapping (standard deviation of activation times [SDAT]). Hemodynamic changes were assessed as the first derivative of LV pressure (LVdP/dtmax).

Results: As compared with baseline, LVs pacing resulted in a larger reduction in QRS area (to 73 ± 22 μVs) and SDAT (to 26 ± 7 ms) than BiV (to 93 ± 26 μVs and 31 ± 7 ms; both p < 0.05) and LVs+RV pacing (to 108 ± 37 μVs; p < 0.05; and 29 ± 8 ms; p = 0.05). The increase in LVdP/dtmax was similar during LVs and BiV pacing (17 ± 10% vs. 17 ± 9%, respectively) and larger than during LVs+RV pacing (11 ± 9%; p < 0.05). There were no significant differences between basal, mid-, or apical LVs levels in LVdP/dtmax and SDAT. In a subgroup of 16 patients, changes in QRS area, SDAT, and LVdP/dtmax were comparable between LVs and HB pacing.

Conclusions: LVs pacing provides short-term hemodynamic improvement and electrical resynchronization that is at least as good as during BiV and possibly HB pacing. These results indicate that LVs pacing may serve as a valuable alternative for CRT.
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http://dx.doi.org/10.1016/j.jacc.2019.11.040DOI Listing
February 2020

Successful thoracoscopic clipping of a thrombus-containing left atrial appendage.

Int J Cardiol Heart Vasc 2020 Feb 5;26:100460. Epub 2020 Jan 5.

Cardiothoracic Surgery, Maastricht University Medical Center, Maastricht, the Netherlands.

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http://dx.doi.org/10.1016/j.ijcha.2019.100460DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6948233PMC
February 2020

Nurse-led vs. usual-care for atrial fibrillation.

Eur Heart J 2020 02;41(5):634-641

Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands.

Background: Nurse-led integrated care is expected to improve outcome of patients with atrial fibrillation compared with usual-care provided by a medical specialist.

Methods And Results: We randomized 1375 patients with atrial fibrillation (64 ± 10 years, 44% women, 57% had CHA2DS2-VASc ≥ 2) to receive nurse-led care or usual-care. Nurse-led care was provided by specialized nurses using a decision-support tool, in consultation with the cardiologist. The primary endpoint was a composite of cardiovascular death and cardiovascular hospital admissions. Of 671 nurse-led care patients, 543 (81%) received anticoagulation in full accordance with the guidelines against 559 of 683 (82%) usual-care patients. The cumulative adherence to guidelines-based recommendations was 61% under nurse-led care and 26% under usual-care. Over 37 months of follow-up, the primary endpoint occurred in 164 of 671 patients (9.7% per year) under nurse-led care and in 192 of 683 patients (11.6% per year) under usual-care [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.69 to 1.04, P = 0.12]. There were 124 vs. 161 hospitalizations for arrhythmia events (7.0% and 9.4% per year), and 14 vs. 22 for heart failure (0.7% and 1.1% per year), respectively. Results were not consistent in a pre-specified subgroup analysis by centre experience, with a HR of 0.52 (95% CI 0.37-to 0.71) in four experienced centres and of 1.24 (95% CI 0.94-1.63) in four less experienced centres (P for interaction <0.001).

Conclusion: Our trial failed to show that nurse-led care was superior to usual-care. The data suggest that nurse-led care by an experienced team could be clinically beneficial (ClinicalTrials.gov NCT01740037).

Trial Registration Number: ClinicalTrials.gov (NCT01740037).
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http://dx.doi.org/10.1093/eurheartj/ehz666DOI Listing
February 2020

Early or Delayed Cardioversion in Recent-Onset Atrial Fibrillation.

N Engl J Med 2019 04 18;380(16):1499-1508. Epub 2019 Mar 18.

From the Departments of Cardiology (N.A.H.A.P., E.A.M.P.D., J.G.L.M.L., H.J.G.M.C.) and Clinical Epidemiology and Medical Technology Assessment (B.A.B.E.), the Cardiovascular Research Institute Maastricht (N.A.H.A.P., E.A.M.P.D., J.G.L.M.L., H.J.G.M.C.), Maastricht University Medical Center, Maastricht, VieCuri Medical Center Noord-Limburg, Venlo (J.G.M.), Zuyderland Medical Center, Heerlen (T.L.), Elisabeth-TweeSteden Hospital, Tilburg (J.W.), Diakonessen Hospital, Utrecht (J.J.J.B.), University of Groningen, Groningen (M.R., I.C.V.G.), VU University Medical Center Amsterdam (O.K.) and Academic Medical Center (J.G.P.T), Amsterdam, Medical Spectrum Twente, Enschede (J.M.V.O.), Amphia Hospital, Breda (M.A.), Antonius Hospital, Sneek (A.O.), Alrijne Hospital, Leiderdorp (C.J.K.), St. Antonius Hospital, Nieuwegein (V.F.V.D.), Haga Teaching Hospital, The Hague (H.R.), St. Franciscus Gasthuis, Rotterdam (A.L.), and Catharina Hospital, Eindhoven (L.R.D) - all in the Netherlands.

Background: Patients with recent-onset atrial fibrillation commonly undergo immediate restoration of sinus rhythm by pharmacologic or electrical cardioversion. However, whether immediate restoration of sinus rhythm is necessary is not known, since atrial fibrillation often terminates spontaneously.

Methods: In a multicenter, randomized, open-label, noninferiority trial, we randomly assigned patients with hemodynamically stable, recent-onset (<36 hours), symptomatic atrial fibrillation in the emergency department to be treated with a wait-and-see approach (delayed-cardioversion group) or early cardioversion. The wait-and-see approach involved initial treatment with rate-control medication only and delayed cardioversion if the atrial fibrillation did not resolve within 48 hours. The primary end point was the presence of sinus rhythm at 4 weeks. Noninferiority would be shown if the lower limit of the 95% confidence interval for the between-group difference in the primary end point in percentage points was more than -10.

Results: The presence of sinus rhythm at 4 weeks occurred in 193 of 212 patients (91%) in the delayed-cardioversion group and in 202 of 215 (94%) in the early-cardioversion group (between-group difference, -2.9 percentage points; 95% confidence interval [CI], -8.2 to 2.2; P = 0.005 for noninferiority). In the delayed-cardioversion group, conversion to sinus rhythm within 48 hours occurred spontaneously in 150 of 218 patients (69%) and after delayed cardioversion in 61 patients (28%). In the early-cardioversion group, conversion to sinus rhythm occurred spontaneously before the initiation of cardioversion in 36 of 219 patients (16%) and after cardioversion in 171 patients (78%). Among the patients who completed remote monitoring during 4 weeks of follow-up, a recurrence of atrial fibrillation occurred in 49 of 164 patients (30%) in the delayed-cardioversion group and in 50 of 171 (29%) in the early-cardioversion group. Within 4 weeks after randomization, cardiovascular complications occurred in 10 patients and 8 patients, respectively.

Conclusions: In patients presenting to the emergency department with recent-onset, symptomatic atrial fibrillation, a wait-and-see approach was noninferior to early cardioversion in achieving a return to sinus rhythm at 4 weeks. (Funded by the Netherlands Organization for Health Research and Development and others; RACE 7 ACWAS ClinicalTrials.gov number, NCT02248753.).
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http://dx.doi.org/10.1056/NEJMoa1900353DOI Listing
April 2019

Shorter cryoballoon applications times do effect efficacy but result in less phrenic nerve injury: Results of the randomized 123 study.

Pacing Clin Electrophysiol 2019 05 5;42(5):508-514. Epub 2019 Mar 5.

Medisch Spectrum Twente, Enschede, The Netherlands.

Background: The second-generation cryoballoon significantly improves outcome of pulmonary vein isolation (PVI) but may cause more complications than the first generation. Currently, no consensus regarding optimal cryoballoon application time exists. The 123-study aimed to assess the minimal cryoballoon application duration necessary to achieve PVI (primary endpoint) and the effect of application duration on prevention of phrenic nerve injury (PNI).

Methods: Patients <75 years of age with paroxysmal atrial fibrillation, normal PV anatomy, and left atrial size <40 cc/m² or <50 mm were randomized to two applications of different duration: "short," "medium," or "long." A total of 222 patients were enrolled, 74 per group.

Results: Duration per application was 105 (101-108), 164 (160-168), and 224 (219-226) s and isolation was achieved in 79, 89, and 90% (P < 0.001) of the PVs after two applications in groups short, medium, and long, respectively. Only for the left PVs, the success rate of the short group was significantly less compared to the medium- and long-duration groups (P < 0.001). PNI during the procedure occurred in 19 PVs (6.5%) in the medium and in 20 PVs (6.8%) in the long duration groups compared to only five PVs (1.7%) in the short duration group (P < 0.001).

Conclusions: Short cryoballoon ablation application times, less than 2 min, did affect the success for the left PVs but not for the right PVs and resulted in less PNI. A PV tailored approach with shorter application times for the right PVs might be advocated.
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http://dx.doi.org/10.1111/pace.13626DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6850154PMC
May 2019

Agatston score of the descending aorta is independently associated with coronary events in a low-risk population.

Open Heart 2018;5(2):e000893. Epub 2018 Nov 24.

Department of Cardiology, Maastricht University Medical Center (MUMC+) and Cardiovascular Research Institute Maastricht (CARIM), Maastricht, The Netherlands.

Objectives: A standard coronary artery calcium scan includes part of the aorta. This additional information is often not included in routine analyses. We aimed to determine the feasibility of assessing the Agatston score of the descending aorta calcification (DAC) on standard coronary calcium scans and the association of this score with coronary events in a low-risk study population.

Methods: Between January 2008 and March 2011, 390 consecutive patients who were referred for cardiac CT as part of work-up for pulmonary vein isolation (n=115) or assessment of presence of coronary artery disease (n=275) were included. At baseline, all patients were free of a history of cardiovascular disease. Two independent observers determined the Agatston score of the ascending aorta and descending aorta.

Results: A total of 16 patients (4.1%) developed coronary events (acute coronary syndrome (n=6) and symptomatic significant coronary artery disease requiring treatment (n=10)) during a follow-up of 67±12 months, with more events in patients with calcifications in the descending aorta than in those without (8.4% vs 3.7 %; p=0.08). Multivariable Cox regression, corrected for Framingham Risk Score (FRS) and coronary Agatston score (CAC), revealed that DAC was independently associated with coronary events (per 100 units; HR: 1.06, 95% CI 1.02 to 1.09; p=0.001). DAC furthermore increased the identification of patients that will experience a coronary event (area under the curve: 0.68 for FRS only, 0.75 for FRS+CAC and 0.78 for FRS+CAC+DAC).

Conclusions: The Agatston score of the descending aorta could be included in the standard analysis of cardiac CT scans of low-risk patients since it holds valuable information for the prediction of coronary events.
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http://dx.doi.org/10.1136/openhrt-2018-000893DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6269642PMC
November 2018

External electrical cardioversion in patients with cardiac implantable electronic devices: Is it safe and is immediate device interrogation necessary?

Pacing Clin Electrophysiol 2018 10 28;41(10):1336-1340. Epub 2018 Aug 28.

Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center (MUMC+), Maastricht, The Netherlands.

Background: Atrial tachyarrhythmias are common in patients with cardiac implantable electronic devices (CIEDs). Restoration of sinus rhythm by external electrical cardioversion (eECV) is frequently used to alleviate symptoms and to ensure optimal device function.

Objectives: To evaluate the safety of eECV in patients with contemporary CIEDs and to assess the need for immediate device interrogation after eECV.

Methods: We conducted a retrospective observational study of 229 patients (27.9% female, age 69 ± 10 years) with a CIED (104 pacemakers, 69 implantable cardioverter defibrillators, and 56 biventricular devices) who underwent eECV between 2008 and 2016 in two centers. Data from device interrogation before eECV, immediately afterwards, and at first follow-up (FU) after eECV were collected. CIED-related complications and adverse events during and after eECV were recorded.

Results: No significant differences between right atrial (RA) and right ventricular (RV) sensing or threshold values before eECV, immediately afterwards, or at FU were observed. A small yet significant decrease was observed in RA and RV impedance immediately after eECV (484 Ω vs 462 Ω, P < 0.001 and 536 Ω vs 514 Ω, P < 0.001, respectively). The RV impedance did not recover to the baseline value (538 Ω vs 527 Ω, P  =  0.02). The impedance changes were without clinical consequences. No changes in left ventricular lead threshold or impedance values were measured. No CIED-related complications or adverse events were documented following eECV.

Conclusion: eECV in patients with contemporary CIEDs is safe. There seems to be no need for immediate device interrogation after eECV.
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http://dx.doi.org/10.1111/pace.13467DOI Listing
October 2018

Effect of Systemic Hypertension With Versus Without Left Ventricular Hypertrophy on the Progression of Atrial Fibrillation (from the Euro Heart Survey).

Am J Cardiol 2018 08 11;122(4):578-583. Epub 2018 May 11.

Maastricht University Medical Center (MUMC+), Department of Cardiology, Maastricht, The Netherlands.

Hypertension is a risk factor for both progression of atrial fibrillation (AF) and development of AF-related complications, that is major adverse cardiac and cerebrovascular events (MACCE). It is unknown whether left ventricular hypertrophy (LVH) as a consequence of hypertension is also a risk factor for both these end points. We aimed to assess this in low-risk AF patients, also assessing gender-related differences. We included 799 patients from the Euro Heart Survey with nonvalvular AF and a baseline echocardiogram. Patients with and without hypertension were included. End points after 1 year were occurrence of AF progression, that is paroxysmal AF becoming persistent and/or permanent AF, and MACCE. Echocardiographic LVH was present in 33% of 379 hypertensive patients. AF progression after 1 year occurred in 10.2% of 373 patients with rhythm follow-up. In hypertensive patients with LVH, AF progression occurred more frequently as compared with hypertensive patients without LVH (23.3% vs 8.8%, p = 0.011). In hypertensive AF patients, LVH was the most important multivariably adjusted determinant of AF progression on multivariable logistic regression (odds ratio 4.84, 95% confidence interval 1.70 to 13.78, p = 0.003). This effect was only seen in male patients (27.5% vs 5.8%, p = 0.002), while in female hypertensive patients, no differences were found in AF progression rates regarding the presence or absence of LVH (15.2% vs 15.0%, p = 0.999). No differences were seen in MACCE for hypertensive patients with and without LVH. In conclusion, in men with hypertension, LVH is associated with AF progression. This association seems to be absent in hypertensive women.
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http://dx.doi.org/10.1016/j.amjcard.2018.04.053DOI Listing
August 2018

The influence of progression of atrial fibrillation on quality of life: a report from the Euro Heart Survey.

Europace 2018 06;20(6):929-934

Department of Cardiology, Maastricht University Medical Center (MUMC+) and Cardiovascular Research Institute Maastricht (CARIM), P. Debyelaan 25, 6229 HX Maastricht, the Netherlands.

Aims: Progression of atrial fibrillation (AF) from paroxysmal to persistent forms is an active field of research. The influence of AF progression on health related quality of life (HRQoL) is currently unknown. We aimed to assess the influence of AF progression on HRQoL, and whether this association is mediated through symptoms, treatment, and major adverse events.

Methods And Results: In the Euro Heart Survey, 967 patients were included with paroxysmal AF who filled out EuroQoL-5D at baseline and at 1 year follow-up. Those who progressed (n = 132, 13.6%) developed more problems during follow-up than those who did not, on all EuroQoL-5D domains (increase in problems on mobility 20.5% vs. 11.4%; self-care 12.9% vs. 6.2%; usual activities 23.5% vs. 14.0%; pain/discomfort 20.5% vs. 13.7%; and anxiety/depression 22.7% vs. 15.7%; all P < 0.05), leading to a decrease in utility [baseline 0.744 ± 0.26, follow-up 0.674 ± 0.36; difference -0.07 (95% CI [-0.126,-0.013], P = 0.02)]. Multivariate analysis showed that the effect of progression on utility is mediated by a large effect of adverse events [stroke (-0.27 (95% CI [-0.43,-0.11]); P = 0.001], heart failure [-0.12 (95% CI [-0.20,-0.05]); P = 0.001], malignancy (-0.31 (95% CI [-0.56,-0.05]); P = 0.02] or implantation of an implantable cardiac defibrillator [-0.12 (95% CI [-0.23,-0.02]); P = 0.03)], as well as symptomatic AF [-0.04 (95% CI [-0.08,-0.01]); P = 0.008].

Conclusion: AF progression is associated with a decrease in HRQoL. However, multivariate analysis revealed that AF progression itself does not have a negative effect on HRQoL, but that this effect can be attributed to a minor effect of the associated symptoms and a major effect of associated adverse events.
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http://dx.doi.org/10.1093/europace/eux217DOI Listing
June 2018

Patent Foramen Ovale With Atrial Septal Aneurysm Is Strongly Associated With Migraine With Aura: A Large Observational Study.

J Am Heart Assoc 2016 12 1;5(12). Epub 2016 Dec 1.

Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.

Background: A patent foramen ovale (PFO) with atrial septal aneurysm (ASA) has been identified as a risk factor for cryptogenic stroke. Patients with migraine with aura (MA) appear to be at risk for silent brain infarction, which might be related to the presence of a PFO. However, the association between MA and PFO with ASA has never been reported. We examined this association in a large observational study.

Methods And Results: Patients (>18 years) who underwent an agitated saline transesophageal echocardiography (cTEE) at our outpatient clinics within a timeframe of 4 years were eligible to be included. Before cTEE they received a validated headache questionnaire. Two neurologists diagnosed migraine with or without aura according to the International Headache Criteria. A total of 889 patients (mean age 56.4±14.3 years, 41.7% women) were included. A PFO was present in 23.2%, an isolated ASA in 2.7%, and a PFO with ASA in 6.9%. The occurrence of migraine was 18.9%; the occurrence of MA was 8.1%. The prevalence of PFO with ASA was significantly higher in patients with MA compared to patients without migraine (18.1% vs 6.1%; OR 3.72, 95% CI 1.86-7.44, P<0.001). However, a PFO without ASA was not significantly associated with MA (OR 1.50, 95% CI 0.79-2.82, P=0.21). Interestingly, a PFO with ASA was strongly associated with MA (OR 2.71, 95% CI 1.23-5.95, P=0.01).

Conclusion: In this large observational study, PFO with ASA was significantly associated with MA only. PFO closure studies should focus on this specific intra-atrial anomaly.
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http://dx.doi.org/10.1161/JAHA.116.003771DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5210450PMC
December 2016

A novel approach for left ventricular lead placement in cardiac resynchronization therapy: Intraprocedural integration of coronary venous electroanatomic mapping with delayed enhancement cardiac magnetic resonance imaging.

Heart Rhythm 2017 01 20;14(1):110-119. Epub 2016 Sep 20.

Department of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands.

Background: Placing the left ventricular (LV) lead at a site of late electrical activation remote from scar is desired to improve cardiac resynchronization therapy (CRT) response.

Objective: The purpose of this study was to integrate coronary venous electroanatomic mapping (EAM) with delayed enhancement cardiac magnetic resonance (DE-CMR) enabling LV lead guidance to the latest activated vein remote from scar.

Methods: Eighteen CRT candidates with focal scar on DE-CMR were prospectively included. DE-CMR images were semi-automatically analyzed. Coronary venous EAM was performed intraprocedurally and integrated with DE-CMR to guide LV lead placement in real time. Image integration accuracy and electrogram parameters were evaluated offline.

Results: Integration of EAM and DE-CMR was achieved using 8.9 ± 2.8 anatomic landmarks and with accuracy of 4.7 ± 1.1 mm (mean ± SD). Maximal electrical delay ranged between 72 and 197ms (57%-113% of QRS duration) and was heterogeneously located among individuals. In 12 patients, the latest activated vein was located outside scar, and placing the LV lead in the latest activated vein remote from scar was accomplished in 10 patients and prohibited in 2 patients. In the other 6 patients, the latest activated vein was located in scar, and targeting alternative veins was considered. Unipolar voltages were on average lower in scar compared to nonscar (6.71 ± 3.45 mV vs 8.18 ± 4.02 mV [median ± interquartile range), P <.001) but correlated weakly with DE-CMR scar extent (R -0.161, P <.001) and varied widely among individual patients.

Conclusion: Integration of coronary venous EAM with DE-CMR can be used during CRT implantation to guide LV lead placement to the latest activated vein remote from scar, possibly improving CRT.
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http://dx.doi.org/10.1016/j.hrthm.2016.09.015DOI Listing
January 2017

Feasibility and Acute Hemodynamic Effect of Left Ventricular Septal Pacing by Transvenous Approach Through the Interventricular Septum.

Circ Arrhythm Electrophysiol 2016 Mar;9(3):e003344

From the Department of Cardiology, Maastricht University Medical Center, The Netherlands (M.M.-R., J.G.L.M.L., Y.B., M.J., H.J.C., K.V.); and Department of Physiology, Maastricht University, Cardiovascular Research Institute Maastricht, The Netherlands (F.W.P.).

Background: Left ventricular septal (LVS) pacing reduces ventricular dyssynchrony and improves cardiac function relative to right ventricular apex (RVA) pacing in animals. We aimed to establish permanent placement of an LVS pacing lead in patients using a transvenous approach through the interventricular septum.

Methods And Results: Ten patients with sinus node dysfunction scheduled for dual-chamber pacemaker implantation were prospectively enrolled. A custom pacing lead with extended helix was introduced via the left subclavian vein and, after positioning against the right ventricular septum (RVS) using a preshaped guiding catheter, driven through the interventricular septum to the LVS. The acute hemodynamic effect of RVA, RVS, and LVS pacing was evaluated by invasive LVdP/dtmax measurements. The lead was successfully delivered to the LVS in all patients. Procedure time and fluoroscopy time shortened with experience. QRS duration was shorter during LVS pacing (144 ± 20 ms) than during RVA (172 ± 33 ms; P = 0.02 versus LVS) and RVS pacing (165 ± 17 ms; P = 0.004 versus LVS). RVA and RVS pacing reduced LVdP/dtmax compared with baseline atrial pacing (-7.1 ± 4.1% and -6.9 ± 4.3%, respectively), whereas LVS pacing maintained LVdP/dtmax at baseline level (1.0 ± 4.3%; P = 0.001 versus RVA and RVS). R-wave amplitude and pacing threshold were 12.2 ± 6.7 mV and 0.5 ± 0.2 V at implant and remained stable during 6-month follow-up without lead-related complications.

Conclusions: Permanent placement of an LVS pacing lead by transvenous approach through the interventricular septum is feasible in patients. LVS pacing preserves acute left ventricular pump function. This new pacing method could serve as an alternative and hemodynamically preferable approach for antibradycardia pacing.
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http://dx.doi.org/10.1161/CIRCEP.115.003344DOI Listing
March 2016

Inappropriate Shock Due to T-Wave Oversensing by a Subcutaneous ICD after Alcohol Septal Ablation for Hypertrophic Cardiomyopathy.

Pacing Clin Electrophysiol 2016 Mar 1;39(3):307-9. Epub 2015 Dec 1.

Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.

A 53-year-old female patient with hypertrophic obstructive cardiomyopathy (HOCM) was admitted for alcohol septal ablation (ASA). A subcutaneous internal cardioverter defibrillator (S-ICD) was implanted for primary prevention. After ASA, the patient developed a right bundle branch block, and the S-ICD delivered a total of five inappropriate shocks due to T-wave oversensing (TWOS). TWOS is a relatively frequent cause of inappropriate shocks in S-ICD patients. After invasive treatment for HOCM, there is a risk of developing intraventricular conduction delay and subsequent changes in QRS and T-wave morphology. This should be taken into consideration when ICD indication is evaluated in HOCM patients.
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http://dx.doi.org/10.1111/pace.12784DOI Listing
March 2016

Vectorcardiographic QRS area identifies delayed left ventricular lateral wall activation determined by electroanatomic mapping in candidates for cardiac resynchronization therapy.

Heart Rhythm 2016 Jan 29;13(1):217-25. Epub 2015 Jul 29.

Department of Cardiology, Maastricht University Medical Center, Maastricht, The Netherlands,. Electronic address:

Background: Delayed left ventricular (LV) lateral wall (LVLW) activation is considered the electrical substrate underlying LV dysfunction amenable to cardiac resynchronization therapy (CRT).

Objective: The purpose of this study was to assess LVLW activation in CRT candidates using coronary venous electroanatomic mapping (EAM) and to investigate whether the QRS area (QRSAREA) on the vectorcardiogram (VCG) can identify delayed LVLW activation.

Methods: Fifty-one consecutive CRT candidates (29 left bundle branch block [LBBB], 15 intraventricular conduction delay [IVCD], 7 right bundle branch block [RBBB]) underwent intraprocedural coronary venous EAM using EnSite NavX. VCGs were constructed from preprocedural digital 12-lead ECGs using the Kors method. QRSAREA was assessed and compared to QRS duration and 5 different LBBB definitions.

Results: Delayed LVLW activation (activation time >75% of QRS duration) occurred in 38 of 51 patients (29/29 LBBB, 8/15 IVCD, 1/7 RBBB). QRSAREA was larger in patients with than in patients without delayed LVLW activation (108 ± 42 µVs vs 51 ± 27 µVs, P < .001), and identified delayed LVLW activation better than QRS duration (area under the curve 0.89 [95% confidence interval 0.79-0.99] vs 0.49 [95% confidence interval 0.33-0.65]). QRSAREA >69 µVs diagnosed delayed LVLW activation with a higher sum of sensitivity (87%) and specificity (92%) than any of the LBBB definitions. Of the different LBBB definitions, the European Society of Cardiology textbook definition performed best with sensitivity of 76% and specificity of 100%.

Conclusion: Coronary venous EAM can be used during CRT implantation to determine the presence of delayed LVLW activation. QRSAREA is a noninvasive alternative for intracardiac measurements of electrical activation, which identifies delayed LVLW activation better than QRS duration and LBBB morphology.
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http://dx.doi.org/10.1016/j.hrthm.2015.07.033DOI Listing
January 2016

Long-term outcome of percutaneous closure of secundum-type atrial septal defects in adults.

EuroIntervention 2010 Nov;6(5):604-10

Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.

Aims: Transcatheter closure of the secundum-type atrial septal defect (ASD) is widely practised. We report complications and efficacy of percutaneous ASD closure in adults using the Amplatzer ASD occluder and the Cardioseal/Starflex device during long-term follow-up.

Methods And Results: Between 1996 and 2008 percutaneous ASD closure was performed in 133 patients (mean age 46.8 ± 16.9 years; 36 men) by using the Amplatzer(r) device in 104 patients and the Cardioseal/Starflex device in 29. During a mean follow-up of 3.4 ± 2.8 years the occurrence of major complications was higher in patients with the Cardioseal/Starflex compared to patients with the Amplatzer(r) devices (17.2 vs. 2.9%, log rank, P=0.005), due to a higher embolisation rate (13.8 vs. 1.0%, log rank, P=0.002). In univariable analysis, the implantation of a Cardioseal/Starflex device (OR 6.0 (CI 1.4-25.2); P=0.01) and a larger device diameter (OR 1.1 (CI 1.0-1.2); P=0.04) were found to be predictors of the occurrence of major complications. Minor complications occurred in 10.5%, recurrent thrombo-embolism in 2.3% and residual shunting at six months was 13.9% without differences between devices. NYHA class improved from 1.8 ± 0.6 before to 1.2 ± 0.4 after closure (P<0.001) without differences between devices.

Conclusions: During long-term follow-up, percutaneous ASD closure in adults is safe and effective when using the Amplatzer(r) device. Larger Cardioseal/Starflex devices are related to a higher embolisation rate. Randomised trials are needed.
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http://dx.doi.org/10.4244/EIJV6I5A101DOI Listing
November 2010

Late device thrombosis after atrial septal defect closure.

Eur Heart J 2010 Jan 25;31(2):142. Epub 2009 Nov 25.

Department of Cardiology, St. Antonius Hospital, Koekoekslaan 1, Nieuwegein, The Netherlands.

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http://dx.doi.org/10.1093/eurheartj/ehp512DOI Listing
January 2010

Haemodynamic effects of patent foramen ovale and atrial septal defect closure: a comparison during percutaneous shunt closure.

Clin Physiol Funct Imaging 2010 Jan 4;30(1):64-8. Epub 2009 Oct 4.

Department of Cardiology, St Antonius Hospital, Nieuwegein, the Netherlands.

Summary Objectives: We investigated the haemodynamic effect of percutaneous closure of an intra-atrial shunt, using non-invasive finger pressure measurements.

Background: Percutaneous closure of both patent foramen ovale (PFO) and atrial septal defect (ASD) is widely practised. Currently no data are available on short-term haemodynamic changes induced by closure.

Methods: Twenty-five consecutive patients (mean age 49 +/- 17 years, 10 men) who underwent a percutaneous closure of a PFO (n = 15) or ASD (n = 10) were included in this study. During the procedure blood pressure and heart rate (HR) were monitored continuously with a Finometer. Changes in systolic, mean, and diastolic pressure, stroke volume (SV), cardiac output (CO) and total peripheral resistance (TPR) were computed from the pressure registrations using Modelflow methodology.

Results: Baseline characteristics were similar for the PFO and ASD patients. After PFO closure none of the haemodynamic parameters changed significantly. After ASD closure the systolic, mean, and diastolic pressures increased 7.1 +/- 5.4 (P = 0.003), 3.8 +/- 3.5 (P = 0.007) and 2.0 +/- 3.0 mmHg (P = ns) respectively. HR decreased 5.1 +/- 5.3 beats per minute (P = 0.01). SV, CO and TPR increased 8.5 +/- 6.4 ml (13.5%; P = 0.002), 0.21 +/- 0.45 l min(-1) (5.6%; P = ns) and 0.02 +/- 0.14 dynes (4.1%; P = ns) respectively. The changes in SV differ between the PFO and ASD patients (P = 0.009).

Conclusions: Using non-invasive finger pressure measurements, we found that SV, mean and systolic blood pressure increased immediately after percutaneous closure of an ASD in adults, whereas the percutaneous PFO closure had no effect on haemodynamic characteristics.
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http://dx.doi.org/10.1111/j.1475-097X.2009.00905.xDOI Listing
January 2010

Is a predominant left-to-right shunt associated with migraine?: A prospective atrial septal defect closure study.

Catheter Cardiovasc Interv 2009 Dec;74(7):1078-84

Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.

Background: A right-to-left shunt, as seen in patients with a patent foramen ovale, seems to be associated with migraine. An atrial septal defect (ASD), however, is characterized by a predominant left-to-right shunt (LRS). We prospectively evaluated the effect of percutaneous ASD closure on migraine

Methods: All 70 consecutive patients (>16 years) who underwent a percutaneous ASD closure between November 2003 and December 2005 in one of the two participating centers were included in the study. On the basis of standardized headache questionnaire, two independent neurologists diagnosed migraine with or without aura (MA+ and MA-, respectively) according to the International Headache Society criteria, before, 6 and 12 months after closure.

Results: Sixty-eight patients (97%; mean age 47.3 + or - 16.4 years; 22% men) agreed to participate in the study and completed the questionnaire. Before ASD closure, the overall prevalence of migraine was 34%, MA+ 22% and MA- 12%. At 6 months follow-up, the headache questionnaire was completed by 63 patients (93%) and the prevalence of overall migraine decreased to 19%, MA+ to 8% and MA- to 11% (Mc Nemar test, P = 0.08, P = 0.07, and P = 1.0, respectively). At 12 months, the prevalence of migraine decreased further to 12%, MA+ to 5% and MA- to 7% (McNemar test, P = 0.003, P = 0.04, and P = 0.29 versus at inclusion, respectively) based on a completed headache questionnaire of 57 patients (84%).

Conclusion: We found a high prevalence of migraine in patients with an ASD, and observed prospectively a reduction in the occurrence of migraine, especially migraine with aura, 1 year after percutaneous closure.
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http://dx.doi.org/10.1002/ccd.22226DOI Listing
December 2009

Closure of a patent foramen ovale is associated with a decrease in prevalence of migraine: a prospective observational study.

Acta Cardiol 2008 Oct;63(5):571-7

Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.

Background: A causal relationship between migraine and a right-to-left shunt, due to a patent foramen ovale (PFO), has been suggested. In mainly retrospective studies, percutaneous closure of a PFO has been associated with a decrease in the prevalence of migraine.

Objective: In this prospective observational study we evaluated whether percutaneous closure of a PFO is associated with a decrease in the prevalence of migraine.

Methods: Between November 2003 and August 2005, we included 92 patients (age >16 years) who underwent a percutaneous closure of a symptomatic PFO, which was considered to be related to a paradoxical embolism.They received a headache questionnaire before and six months after closure.Two neurologists diagnosed migraine, according to the International Headache Criteria.

Results: Eighty-nine of 92 patients (97%, mean age 51.6 +/- 12.3 years, 63 men) completed the questionnaire immediately before PFO closure.The overall prevalence of migraine was 27.0%, for migraine without aura (MA-) 15.7%, and for migraine with aura (MA+) 11.2%. After more than six months of follow-up 84 of 89 patients (94%, mean age 52.1 +/- 12.0 years, 60 men) returned the questionnaire. The overall prevalence of migraine in this group decreased from 28.6% to 10.7% (P = 0.001), for MA-from 16.7% to 8.3% (P = 0.07), and for MA+ from 11.9% to 2.4% (P = 0.02).

Conclusions: Percutaneous PFO closure is related to a decrease in the prevalence of migraine in this prospective observational study. However, randomized placebo controlled trials have to confirm these findings.
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http://dx.doi.org/10.2143/AC.63.5.2033223DOI Listing
October 2008

Outcome after percutaneous closure of a patent foramen ovale using the Intrasept device: a multi-centre study.

Catheter Cardiovasc Interv 2008 May;71(6):822-8

Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium.

Objectives: This multi-centre study reports safety and efficacy of percutaneous patent foramen ovale (PFO) closure, using the fourth generation Intrasept device.

Background: PFO has been associated with paradoxical embolism and cryptogenic stroke. Percutaneous PFO closure seems to reduce the risk for recurrent paradoxical thrombo-embolism. Currently, different devices are used for PFO closure.

Methods: Patients, who underwent a PFO closure with the Intrasept device (Cardia, Eagan, MN) between July 2002 and September 2006, were included in the study. The primary endpoint was defined as reoccurrence of stroke, transient ischemic attack (TIA), or peripheral thrombo-embolism. Peri-procedural and mid-term complications were reported.

Results: Four-hundred thirty patients (mean age 50.7 +/- 13.0 years, 231 men) underwent closure. The indications were cryptogenic stroke (69.8%), TIA (23.5%), peripheral embolism (3.3%), and other (3.5%). The median follow-up time was 0.8 years, range 3.9 years. The primary endpoint occurred in 0.5% for stroke, in 2.5% for TIA, and in none for peripheral embolism. Peri-procedural complications were reported in 11.5% of cases, from which 0.2% was defined as major. No severe complications occurred during mid-term follow-up. A residual shunt was present in 12.5% of patients who did not suffer from a recurrent event, compared to 36.4% of patients who reached the primary endpoint (P = 0.04).

Conclusion: This multi-centre study suggests that percutaneous closure of a symptomatic PFO with the fourth generation Intrasept device is safe and might be effective to prevent the recurrence of paradoxical thrombo-embolic events.
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http://dx.doi.org/10.1002/ccd.21458DOI Listing
May 2008