Guido H. van Welsenes

Predicting Ventricular Arrhythmias in Patients with Ischemic Heart Disease: Clinical Application of the ECG derived QRS-T Angle

Background—In patients with primary prevention implantable cardioverter-defibrillators (ICDs), the incidence of life-threatening ventricular arrhythmias resulting in ICD therapy is relatively low, prompting for better risk stratification. The aim of this study was to assess the value of the QRS-T angle for prediction of ICD therapy and mortality in primary prevention patients with ischemic heart disease. Methods and Results—ICD patients (n=412, 361 men; age, 63±11 years) with ischemic heart disease and a left ventricular ejection fraction ≤40% were included. After device implantation, the occurrence of appropriate ICD therapy and mortality was noted. A survival analysis was performed comparing patients with a planar QRS-T angle ≤90° (n=124, 30%) with patients with a planar QRS-T angle >90° before device implantation. Furthermore, patients with a spatial QRS-T angle ≤100° (n=56, 14%) were compared with patients with a spatial QRS-T angle >100°, before implantation. For patients with a planar QRS-T angle >90° as compared with ≤90°, the adjusted hazard ratio for the occurrence of appropriate device therapy was 2.4 (95% CI, 1.1 to 5.2); a spatial QRS-T angle >100° was associated with an adjusted hazard ratio of 7.3 (95% CI, 1.0 to 53.8). Furthermore, a spatial QRS-T angle ≤100° exhibited a positive predictive value of 98% (95% CI, 95 to 100) for the prediction of an appropriate therapy-free follow-up. Conclusions—A wide QRS-T angle is a strong predictor of appropriate device therapy in primary prevention ICD recipients with ischemic heart disease. Furthermore, a spatial QRS-T angle ≤100° might be of value in the identification of patients in whom, although currently indicated, ICD treatment should be reconsidered.

Long-term follow-up of primary and secondary prevention implantable cardioverter defibrillator patients

AIMS The beneficial effects of implantable cardioverter defibrillators (ICDs) in primary and secondary prevention patients are well established. However, data on potential differences between both groups in mortality and ICD therapy rates during long-term follow-up are scarce. The aim of the study was to assess differences in mortality and ICD therapy between secondary and primary prevention ICD recipients. METHODS AND RESULTS With the exception of patients with congenital monogenetic cardiac disease, all patients treated with an ICD, regardless of the underlying cardiac pathology, from 1996 to 2008 at the Leiden University Medical Center were included in the current analysis. The study population was grouped by the type of prevention (secondary or primary) for sudden cardiac death. The primary endpoint was all-cause mortality. The secondary endpoint was the occurrence of device therapy (appropriate or inappropriate). A total of 2134 (80% men, mean age 63 ± 12 years) ICD recipients were included. Of these, 1302 (61%) patients received an ICD for primary prevention of sudden cardiac death and 832 (39%) patients for secondary prevention. During a mean follow-up of 3.4 ± 2.8 years, 423 (20%) patients died. The 5-year cumulative incidence of mortality was 25% [95% confidence intervals (CI): 21-29%] for primary prevention patients and 23% (95% CI: 20-26%) for secondary prevention patients. Secondary prevention patients exhibited a 74% increased risk for appropriate therapy when compared with primary prevention patients [hazard ratios (HR): 1.7; P< 0.001]. A comparable risk for inappropriate shocks was observed (HR: 1.0; P= 0.9). CONCLUSION During long-term follow-up, primary prevention patients exhibited a lower risk of appropriate therapy, but comparable mortality rates were observed between both groups. Both groups showed similar occurrence of inappropriate shocks.

Prognostic Importance of Atrial Fibrillation in Implantable Cardioverter-Defibrillator Patients

OBJECTIVES This study aimed to assess the prevalence of different types of atrial fibrillation (AF) and their prognostic importance in implantable cardioverter-defibrillator (ICD) patients. BACKGROUND The prevalence of AF has taken epidemic proportions in the population with cardiovascular disease. The prognostic importance of different types of AF in ICD patients remains unclear. METHODS Data on 913 consecutive patients (79% men, mean age 62 + or - 13 years) receiving an ICD at the Leiden University Medical Center were prospectively collected. Among other characteristics, the existence and type of AF (paroxysmal, persistent, or permanent) were assessed at implantation. During follow-up, the occurrence of appropriate or inappropriate device therapy as well as mortality was noted. RESULTS At implantation, 73% of patients had no history of AF, 9% had a history of paroxysmal AF, 7% had a history of persistent AF, and 11% had permanent AF. During 833 + or - 394 days of follow-up, 117 (13%) patients died, 228 (25%) patients experienced appropriate device discharge, and 139 (15%) patients received inappropriate shocks. Patients with permanent AF exhibited more than double the risk of mortality, ventricular arrhythmias triggering device discharge, and inappropriate device therapy. Patients with paroxysmal or persistent AF did not show a significant increased risk of mortality or appropriate device therapy but demonstrated almost 3 times the risk of inappropriate device therapy. CONCLUSIONS In the population currently receiving ICD treatment outside the setting of clinical trials, a large portion has either a history of AF or permanent AF. Both types of AF have prognostic implications for mortality and appropriate as well as inappropriate device discharge.

Clinical prediction model for death prior to appropriate therapy in primary prevention implantable cardioverter defibrillator patients with ischaemic heart disease: the FADES risk score.

Objectives To construct a risk score out of baseline variables to estimate the risk of death without prior implantable cardioverter defibrillator (ICD) in primary prevention ICD patients with ischaemic heart disease. Design Retrospective cohort study. Setting Tertiary care facility in The Netherlands. Patients All patients with ischaemic heart disease who received an ICD for primary prevention of sudden cardiac death at the Leiden University Medical Center, Leiden, The Netherlands in the period 1996–2009. Main outcome measure All-cause mortality without prior appropriate ICD therapy (anti-tachycardia pacing or shock). Results 900 patients (87% men, mean age 64±10 years) were included in the analysis. During a median follow-up of 669 days (IQR 363–1322 days), 150 patients (17%) died and 191 (21%) patients received appropriate device therapy. 114 (13%) patients died without prior appropriate therapy. Stratification of the risk for death without prior appropriate therapy resulted in risk categorisation of patients as low, intermediate or high risk. NYHA ≥III, advanced age, diabetes mellitus, left ventricular ejection fraction ≤25% and a history of smoking were significant independent predictors of death without appropriate ICD therapy. 5-year cumulative incidence for death without prior appropriate therapy ranged from 10% (95% CI 6% to 16%) in low-risk patients to 41% (95% CI 33% to 51%) in high-risk patients. Conclusions The risk of death without prior appropriate ICD therapy can be predicted in primary prevention ICD patients with ischaemic heart disease, which facilitates patient-tailored risk estimation.

Primary prevention implantable cardioverter defibrillator recipients: the need for defibrillator back-up after an event-free first battery service-life.

ICD Replacement After a Therapy‐Free First Service‐Life. Introduction: In primary prevention implantable cardioverter defibrillator (ICD) patients, the relatively low incidence of ventricular arrhythmias (VA) combined with the limited battery service‐life potentially results in a large group of patients who have had no benefit of the ICD during first service‐life. Data on the occurrence of VA after device replacement remain scarce. The purpose of this study was to give clinicians better insight in the dilemma whether or not to replace an ICD after an event‐free first battery service‐life.

Update on small-diameter implantable cardioverter-defibrillator leads performance.

Background: The performance of small diameter implantable cardioverter defibrillator (ICD) leads is questionable. However, data on performance during long‐term follow‐up are scarce. The aim of this study is to provide an update for the lead failure and cardiac perforation rate of Medtronics Sprint Fidelis ICD lead (Medtronic Inc., Minneapolis, MN, USA) and St. Jude Medicals Riata ICD lead (St. Jude Medical Inc., St. Paul, MN, USA).

Mortality risk score in primary prevention implantable cardioverter defibrillator recipients with non-ischaemic or ischaemic heart disease

AIMS To assess survival and to construct a baseline mortality risk score in primary prevention implantable cardioverter defibrillator (ICD) patients with non-ischaemic or ischaemic heart disease. METHODS AND RESULTS Since 1996, data of all consecutive patients who received an ICD system in the Leiden University Medical Center were collected and assessed at implantation. For the current study, all 1036 patients [age 63 (SD 11) years, 81% male] with a primary indication for defibrillator implantation were evaluated and followed for 873 (SD 677) days. During follow-up, 138 patients (13%) died. Non-ischaemic and ischaemic patients demonstrated similar survival but exhibited different factors that influence risk for mortality. A risk score, consisting of simple baseline variables could stratify patients in low, intermediate, and high risk for mortality. In non-ischaemic patients, annual mortality was 0.4% (95% CI 0.0-2.2%) in low risk and 9.4% (95% CI 6.6-13.1%) in high risk patients. In ischaemic patients, mortality was 1.0% (95% CI 0.2-3.0%) in low risk and 17.8% (95% CI 13.6-22.9%) in high risk patients. CONCLUSION Utilization of an easily applicable baseline risk score can create an individual patient-tailored estimation on mortality risk to aid clinicians in daily practice.

THE ROLE OF DIFFERENT TYPES OF ATRIAL FIBRILLATION ON APPROPRIATE AND INAPPROPRIATE DEVICE THERAPY AND SURVIVAL IN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR PATIENTS

Background: The prevalence of atrial fibrillation (AF) has taken epidemic proportions in the population with cardiovascular disease. However, the prognostic importance of different types of AF in implantable cardioverter defibrillator (ICD) patients remains unclear. The current study assessed the prevalence of different types of atrial fibrillation and their prognostic importance in ICD recipients. Methods: Data on 913 (79% men, mean age 62 ± 13 years) consecutive patients receiving an ICD at the Leiden University Medical Center were prospectively collected. Among other characteristics, the existence and type of AF (paroxysmal, persistent or permanent) was assessed at implantation. During follow-up, the occurrence of appropriate or inappropriate device therapy, as well as mortality was noted. Results: At implantation, 73% of patients had no history of AF, 9% had a history of paroxysmal AF, 7% had a history of persistent AF and 11% had permanent AF. During 833 ± 394 days follow-up, 117 patients (13%) died, 228 patients (25%) experienced appropriate device discharge and 139 patients (15%) received inappropriate shocks. Patients with permanent AF exhibited approximately twice the risk for mortality (HR 1.7, 95% CI 1.02.7, p=0.033), ventricular arrhythmias triggering device discharge (HR 2.2, 95% CI 1.6-3.2, p<0.001), and inappropriate device therapy (HR 2.7, 95% CI 1.7-4.4, p<0.001). In contrary, patients with paroxysmal or persistent AF did not show a significant increased risk for mortality or appropriate device therapy but demonstrated almost three times risk for inappropriate device therapy (HR 2.9, 95% CI 1.7-4.8, p<0.001). Conclusions: In the population currently receiving ICD treatment outside the setting of clinical trials a large portion has either a history of AF or permanent AF. Both types of AF have prognostic implications for mortality and appropriate, as well as inappropriate device discharge.

THE EFFECT OF ICD REPLACEMENT ON THE REQUIREMENT FOR SURGICAL RE-INTERVENTION DUE TO INFECTIOUS AND NON-INFECTIOUS CAUSES.

Abstract Category: Defibrillation/Implantable Antiarrhythmia DevicesPresentation Number: 1188-125Authors: Joep Thijssen, C. Jan Willem Borleffs, Mihaly K. de Bie, Johannes B. van Rees, Guido H. van Welsenes, Ernst E. van der Wall, Lieselot van Erven, Jeroen J. Bax, Suzanne C. Cannegieter, Martin J. Schalij, Leiden University Medical Center, Leiden, The Netherlands Background: Despite the positive effect on mortality in selected patients, limited service life of the implantable cardioverter defibrillator (ICD) results in device replacement in an estimated 70% of patients. However, the effect of replacement on the occurrence of complications, requiring surgical re-intervention, remains unclear.Methods: All patients receiving an ICD in the Leiden University medical Center were included and evaluated at baseline and during periodical three-six months follow-up. Procedure-related complications requiring surgical re-intervention following implantation or replacement were analyzed. ICDs were divided in a group of first implanted ICDs and a group of replacement ICDs.Results: A total of 3161 ICDs (2415 first implanted and 746 replacement) were included. In total, 145 surgical re-interventions were required in 122 (3.9%) patients. The cumulative event-rate for first surgical re-intervention in all implanted ICDs was 4.7% (95% CI 3.9-5.5%) during 3 years follow-up. Replacement ICDs exhibited a doubled requirement for surgical re-intervention (rate ratio 2.2, 95% CI 1.5-3.0, p<0.001). When compared to first implanted ICDs, the occurrence of surgical re-intervention in replacement ICDs was 2.5 (95% CI 1.6-3.7, p<0.001) times higher for infectious and 1.7 (95% CI 0.9-3.0, p=0.090) for non-infectious causes.Conclusions: ICD replacement induces a doubled risk for the requirement for surgical re-intervention due to infectious, as well as non infectious cause.

Predicting Ventricular Arrhythmias in Patients With Ischemic Heart DiseaseCLINICAL PERSPECTIVE: Clinical Application of the ECG-Derived QRS-T Angle

Background—In patients with primary prevention implantable cardioverter-defibrillators (ICDs), the incidence of life-threatening ventricular arrhythmias resulting in ICD therapy is relatively low, prompting for better risk stratification. The aim of this study was to assess the value of the QRS-T angle for prediction of ICD therapy and mortality in primary prevention patients with ischemic heart disease. Methods and Results—ICD patients (n=412, 361 men; age, 63±11 years) with ischemic heart disease and a left ventricular ejection fraction ≤40% were included. After device implantation, the occurrence of appropriate ICD therapy and mortality was noted. A survival analysis was performed comparing patients with a planar QRS-T angle ≤90° (n=124, 30%) with patients with a planar QRS-T angle >90° before device implantation. Furthermore, patients with a spatial QRS-T angle ≤100° (n=56, 14%) were compared with patients with a spatial QRS-T angle >100°, before implantation. For patients with a planar QRS-T angle >90° as compared with ≤90°, the adjusted hazard ratio for the occurrence of appropriate device therapy was 2.4 (95% CI, 1.1 to 5.2); a spatial QRS-T angle >100° was associated with an adjusted hazard ratio of 7.3 (95% CI, 1.0 to 53.8). Furthermore, a spatial QRS-T angle ≤100° exhibited a positive predictive value of 98% (95% CI, 95 to 100) for the prediction of an appropriate therapy-free follow-up. Conclusions—A wide QRS-T angle is a strong predictor of appropriate device therapy in primary prevention ICD recipients with ischemic heart disease. Furthermore, a spatial QRS-T angle ≤100° might be of value in the identification of patients in whom, although currently indicated, ICD treatment should be reconsidered.