Abstract 16484: Primary Prevention Implantable Cardioverter Defibrillator Utilization for Hypertrophic Cardiomyopathy in US vs Non-US: Findings From the Share Registry

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Victor Nauffal ◽  
Peter Marstrand ◽  
Larry Han ◽  
iacopo olivotto ◽  
Adam S Helms ◽  
...  

Introduction: Risk stratification for sudden cardiac death (SCD) in hypertrophic cardiomyopathy (HCM) has evolved with notable differences in international practice trends and US vs European guidelines. Hypothesis: Utilization of primary prevention implantable cardioverter defibrillators (ICD) is higher in the US. Methods: We examined rates of primary prevention ICD implantation in 5,063 HCM patients in the international SHaRe registry from 2000 - 2020 (NUS=2,390; Nnon-US=2,673). Using multiple logistic regression we compared probability of ICD implantation for US vs non-US sites adjusting for standard SCD risk factors (Figure 1A). Interaction tests were performed to identify risk factors differentially associated with ICD implantation in US vs non-US sites after 2014 when the European Society of Cardiology (ESC) risk score was introduced. Results: The odds of ICD implantation were 3-fold higher in US sites [ORUS/non-US=3.11 (2.54 -3.81)] (Figure 1A). Odds remained similar after adjustment for ESC risk score [OR =3.17 (2.57 -3.91)]. Implantation rates were higher in the US throughout the study period with a notable drop in rates in both US and non-US sites after 2014 and a reduction in the magnitude of the difference in ICD utilization between US and non-US sites (ORUS/non-US (<2014) =4.20 (3.05-5.78) vs. ORUS/non-US (≥2014)=2.55 (1.89-3.44); pinteraction<0.001) (Figure 1B). Non-sustained ventricular tachycardia was a stronger predictor of ICD implantation in US sites [ORUS=4.9 (3.4-7.0) vs ORnon-US= 2.1 (1.2-3.6); pinteraction=0.005], whereas, left atrial diameter (> 40 mm) was a stronger predictor in non-US sites [ORNon-US=2.9 (2.1-4.0) vs ORUS=1.3 (1-1.6); pinteraction <0.001]. Conclusions: ICD utilization rates vary globally. In this study, primary prevention ICD utilization rates were 3-fold higher in the US despite adjustment for standard SCD risk factors. Further studies are needed to evaluate outcomes of these practice differences.

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Amalie C Thavikulwat ◽  
Todd T Tomson ◽  
Bradley P Knight ◽  
Robert O Bonow ◽  
Lubna Choudhury

Introduction: Hypertrophic cardiomyopathy (HCM) is a leading cause of sudden cardiac death (SCD) in young adults. Implantable cardioverter defibrillators (ICD) effectively terminate ventricular tachycardia (VT) and fibrillation (VF) that cause SCD, but the reported prevalence of and patient characteristics leading to appropriate ICD therapy in HCM have been variable. Hypothesis: We hypothesized that some risk factors may be more prevalent than others in patients with HCM who receive appropriate ICD therapy and that the overall incidence of appropriate therapy may be lower than that reported previously. Methods: We retrospectively studied all patients with HCM who were treated with ICDs at our referral center from 2000-2013 to determine the rates of appropriate and inappropriate ICD therapies. Results: Of 1136 patients with HCM, we identified 135 who underwent ICD implantation (125 for primary and 10 for secondary prevention), aged 18-81 years (mean 48±17) at the time of implantation. The mean follow-up time was 5.2±4.5 years. Appropriate ICD intervention occurred in 20 of 135 patients (2.8%/year) by providing a shock or antitachycardia pacing in response to VT or VF. The annual rate of appropriate ICD therapy was 2.4%/year for primary and 7.2%/year for secondary prevention devices. Commonly used risk factors were equally prevalent among patients who received appropriate therapy and those who did not; furthermore, the likelihood of receiving appropriate therapy in the presence of each risk factor was similar (Figure). Inappropriate ICD therapy occurred in 27 patients (3.8%/year). Conclusions: ICDs provide clear benefit to patients who experience life-threatening arrhythmias, particularly those being treated for secondary prevention. However, the appropriate therapy rate for primary prevention was lower than previously reported, and no single risk factor appeared to have stronger association with appropriate ICD therapy than others.


2016 ◽  
Vol 5 (3) ◽  
pp. 188 ◽  
Author(s):  
Amar Trivedi ◽  
Bradley P Knight ◽  
◽  

Hypertrophic cardiomyopathy (HCM) is a common and heterogeneous disorder that increases an individual’s risk of sudden cardiac death (SCD). This review article discusses the relevant factors that are involved in the challenge of preventing SCD in patients with HCM. The epidemiology of SCD in patients is reviewed as well as the structural and genetic basis behind ventricular arrhythmias in HCM. The primary prevention of SCD with implantable cardioverter-defibrillator (ICD) therapy is the cornerstone of modern treatment for individuals at high risk of SCD. The focus here is on the current and emerging predictors of SCD as well as risk stratification recommendations from both North American and European guidelines. Issues related to ICD implantation, such as programming, complications and inappropriate therapies, are discussed. The emerging role of the fully subcutaneous ICD and the data regarding its implantation are reviewed.


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Eloi Marijon ◽  
Rui Providencia ◽  
Pascal Defaye ◽  
Didier Klug ◽  
Daniel Gras ◽  
...  

Background: Data regarding sex specificities in the use, benefits and complications of implantable cardioverter-defibrillators (ICDs) in primary prevention in the real-world European setting are sparse. Methods: Using a large multicentric cohort of consecutive patients referred for ICD implantation for primary prevention (2002-2012), in the setting of coronary artery disease or dilated cardiomyopathy, we examined potential sex differences in subjects’ characteristics and outcomes. Results: Of 5,539 patients, only 837 (15.1%) were women and 53.8% received cardiac resynchronization therapy (CRT-D). Compared to men, women presented a significantly higher proportion of dilated cardiomyopathy (60.2% vs. 36.2%, P120ms: 74.6% vs. 68.5%, P=0.003), higher New York Heart Association functional class (2.5±0.7 vs. 2.4±0.7, P=0.003) and lower prevalence of atrial fibrillation (18.7% vs. 24.9%, P<0.001). During a 16,786 patient-years follow-up, overall, fewer appropriate therapies were observed in women (HR = 0.59, CI95% 0.45-0.76; P<0.001). By contrast, no sex-specific interaction was observed for inappropriate shocks (OR for women = 1.00, 95%CI 0.74-1.35, P=0.997) and mortality (HR = 0.87; 95%CI 0.66-1.15, P=0.324), with similar patterns of cause of deaths. Conclusion: In our real life registry, women account for the minority of ICD recipients. While female ICD recipients present with features of more severe heart failure in the setting of primary prevention of sudden cardiac death, we observed they have a 40% lower incidence of appropriate therapies.


Author(s):  
Victor Nauffal ◽  
Peter Marstrand ◽  
Larry Han ◽  
Victoria N Parikh ◽  
Adam S Helms ◽  
...  

Abstract Aims  Risk stratification algorithms for sudden cardiac death (SCD) in hypertrophic cardiomyopathy (HCM) and regional differences in clinical practice have evolved over time. We sought to compare primary prevention implantable cardioverter defibrillator (ICD) implantation rates and associated clinical outcomes in US vs. non-US tertiary HCM centres within the international Sarcomeric Human Cardiomyopathy Registry. Methods and results We included patients with HCM enrolled from eight US sites (n = 2650) and five non-US (n = 2660) sites and used multivariable Cox-proportional hazards models to compare outcomes between sites. Primary prevention ICD implantation rates in US sites were two-fold higher than non-US sites (hazard ratio (HR) 2.27 [1.89–2.74]), including in individuals deemed at high 5-year SCD risk (≥6%) based on the HCM risk-SCD score (HR 3.27 [1.76–6.05]). US ICD recipients also had fewer traditional SCD risk factors. Among ICD recipients, rates of appropriate ICD therapy were significantly lower in US vs. non-US sites (HR 0.52 [0.28–0.97]). No significant difference was identified in the incidence of SCD/resuscitated cardiac arrest among non-recipients of ICDs in US vs. non-US sites (HR 1.21 [0.74–1.97]). Conclusion  Primary prevention ICDs are implanted more frequently in patients with HCM in US vs. non-US sites across the spectrum of SCD risk. There was a lower rate of appropriate ICD therapy in US sites, consistent with a lower-risk population, and no significant difference in SCD in US vs. non-US patients who did not receive an ICD. Further studies are needed to understand what drives malignant arrhythmias, optimize ICD allocation, and examine the impact of different ICD utilization strategies on long-term outcomes in HCM.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Tara Bharucha ◽  
Andrew M Davis ◽  
Christian Turner ◽  
Robert Justo ◽  
Terry Robertson ◽  
...  

Introduction Better data regarding the incidence and risk factors for sudden cardiac death (SCD) in children with cardiomyopathy (CM) is critical in defining appropriate primary prevention strategies. Methods The National Australian Childhood Cardiomyopathy Study is a prospective cohort study, including all children in Australia with primary CM diagnosed at 0 – 10 years of age, between 1987–1997. SCD was defined as sudden and unexpected death in children who were not hospitalized and not in congestive heart failure at the time of death. Nine subjects with sudden death as presenting symptom were excluded. Indexed echocardiographic measurements at latest follow-up were compared between subjects with SCD and survivors. Results Study criteria were met by 291 children. Mean duration of follow-up was 9.2 years. The incidence of sudden death relative to each CM type, for all cases and as a proportion of deaths, is shown in the Table : Incidence of SCD by CM type. SCD incidence was significantly associated with CM type, for all cases ( p = 0.006) and when only those subjects who died were considered ( p = 0.005), with LVNC and RCM having up to 4 times the risk of other CM types. Children with familial DCM had a significantly higher rate of SCD than subjects with non-familial CM (12% vs 3%; p = 0.028), however, familial CM was not a risk factor in other CM types. DCM SCD subjects had larger LVEDd Z score than survivors (median 5.53 vs 1.16; p <0.0001) and lower FS Z score (median −9.23 vs −0.51; p = 0.0025). HCM SCD subjects had thicker LVPW dimension Z scores than survivors (median 4.63 vs 1.18; p = 0.007). Twelve subjects (2 DCM, 8 HCM and 2 LVNC) underwent ICD implantation (8/12 for primary prevention). Conclusions: This population based study defines new risk factors for sudden death in children with CM. RCM is well known to have a high incidence of SCD. In addition, children with LVNC and those with DCM who have severe dilatation, systolic dysfunction or familial DCM are at increased risk of sudden death.


Author(s):  
Constantinos O’Mahony

Sudden cardiac death (SCD) secondary to ventricular arrhythmias is the most common mode of death in hypertrophic cardiomyopathy (HCM) and can be effectively prevented with an implantable cardioverter defibrillator (ICD). The risk of SCD in HCM relates to the severity of the phenotype and regular risk stratification is an integral part of routine clinical care. For the primary prevention of SCD, risk stratification involves the assessment of seven readily available clinical parameters (age, maximal left ventricular wall thickness, left atrial diameter, left ventricular outflow tract gradient, non-sustained ventricular tachycardia, unexplained syncope, and family history of SCD) which are used to estimate the risk of SCD within 5 years of clinical evaluation using a statistical risk prediction model (HCM Risk-SCD). The 2014 European Society of Cardiology Guidelines provide a framework to aid clinical decisions and consider patients with a 5-year risk of SCD of less than 4% as low risk and recommend regular assessment while those with a risk of 6% or higher should be considered for an ICD. In patients with an intermediate risk (4% to <6%) ICD implantation may also be considered after taking into account age, co-morbid conditions, socioeconomic factors, and the psychological impact of therapy. Survivors of ventricular fibrillation arrest should receive an ICD for secondary prevention unless their life expectancy is less than 1 year. Following device implantation, patients should be followed up for device- and disease-related complications, particularly heart failure and cerebrovascular disease.


2020 ◽  
Vol 41 (36) ◽  
pp. 3437-3447 ◽  
Author(s):  
Markus Zabel ◽  
Rik Willems ◽  
Andrzej Lubinski ◽  
Axel Bauer ◽  
Josep Brugada ◽  
...  

Abstract Aims The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter-Defibrillators (EU-CERT-ICD), a prospective investigator-initiated, controlled cohort study, was conducted in 44 centres and 15 European countries. It aimed to assess current clinical effectiveness of primary prevention ICD therapy. Methods and results We recruited 2327 patients with ischaemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM) and guideline indications for prophylactic ICD implantation. Primary endpoint was all-cause mortality. Clinical characteristics, medications, resting, and 12-lead Holter electrocardiograms (ECGs) were documented at enrolment baseline. Baseline and follow-up (FU) data from 2247 patients were analysable, 1516 patients before first ICD implantation (ICD group) and 731 patients without ICD serving as controls. Multivariable models and propensity scoring for adjustment were used to compare the two groups for mortality. During mean FU of 2.4 ± 1.1 years, 342 deaths occurred (6.3%/years annualized mortality, 5.6%/years in the ICD group vs. 9.2%/years in controls), favouring ICD treatment [unadjusted hazard ratio (HR) 0.682, 95% confidence interval (CI) 0.537–0.865, P = 0.0016]. Multivariable mortality predictors included age, left ventricular ejection fraction (LVEF), New York Heart Association class &lt;III, and chronic obstructive pulmonary disease. Adjusted mortality associated with ICD vs. control was 27% lower (HR 0.731, 95% CI 0.569–0.938, P = 0.0140). Subgroup analyses indicated no ICD benefit in diabetics (adjusted HR = 0.945, P = 0.7797, P for interaction = 0.0887) or those aged ≥75 years (adjusted HR 1.063, P = 0.8206, P for interaction = 0.0902). Conclusion In contemporary ICM/DCM patients (LVEF ≤35%, narrow QRS), primary prophylactic ICD treatment was associated with a 27% lower mortality after adjustment. There appear to be patients with less survival advantage, such as older patients or diabetics.


Author(s):  
Nikhil Shah

Background: Implantable cardioverter-defibrillators (ICDs) can be life-saving devices, although they are expensiveand may cause complications. In 2013, several professional societies published joint appropriate use criteria (AUC)assessing indications for ICD implantation. Data evaluating the clinical application of AUC are limited. Previous registry-based studies estimated that 22.5% of primary prevention ICD implantations were “non-evidence-based” implantations. On the basis of AUC, we aimed to determine the prevalence of “rarely appropriate” ICD implantation at our institution for comparison with previous estimates.Methods: We reviewed 286 patients who underwent ICD implantation between 2013 and 2016. Appropriateness of each ICD implantation was assessed by independent review and rated on the basis of AUC.Results: Of 286 ICD implantations, two independent reviewers found that 89.5% and 89.2%, respectively, were appropriate,5.6% and 7.3% may be appropriate, and 1.8% and 2.1% were rarely appropriate. No AUC indication was found for 3.5% and 3.4% of ICD implantations, respectively. Secondary prevention ICD implantations were more likely rarely appropriate (2.6% vs. 1.2% and 3.6% vs. 1.1%) or unrated (6.0% vs. 1.2% and 2.7% vs. 0.6%). The reviewers found 3.5% and 3.4% of ICD implantations, respectively, were non-evidence-based implantations. The difference in rates between reviewers was not statistically significant.Conclusion: Compared with prior reports, our prevalence of rarely appropriate ICD implantation was very low. Thehigh appropriate use rate could be explained by the fact that AUC are based on current clinical practice. The AUC couldbenefit from additional secondary prevention indications. Most importantly, clinical judgement and individualized care should determine which patients receive ICDs irrespective of guidelines or criteria.


Author(s):  
Praloy Chakraborty ◽  
Adrian M. Suszko ◽  
Karthik Viswanathan ◽  
Kimia Sheikholeslami ◽  
Danna Spears ◽  
...  

Background Unlike T‐wave alternans (TWA), the relation between QRS alternans (QRSA) and ventricular arrhythmia (VA) risk has not been evaluated in hypertrophic cardiomyopathy (HCM). We assessed microvolt QRSA/TWA in relation to HCM risk factors and late VA outcomes in HCM. Methods and Results Prospectively enrolled patients with HCM (n=130) with prophylactic implantable cardioverter‐defibrillators underwent digital 12‐lead ECG recordings during ventricular pacing (100–120 beats/min). QRSA/TWA was quantified using the spectral method. Patients were categorized as QRSA+ and/or TWA+ if sustained alternans was present in ≥2 precordial leads. The VA end point was appropriate implantable cardioverter‐defibrillator therapy over 5 years of follow‐up. QRSA+ and TWA+ occurred together in 28% of patients and alone in 7% and 7% of patients, respectively. QRSA magnitude increased with pacing rate (1.9±0.6 versus 6.2±2.0 µV; P =0.006). Left ventricular thickness was greater in QRSA+ than in QRSA− patients (22±7 versus 20±6 mm; P =0.035). Over 5 years follow‐up, 17% of patients had VA. The annual VA rate was greater in QRSA+ versus QRSA− patients (5.8% versus 2.0%; P =0.006), with the QRSA+/TWA− subgroup having the greatest rate (13.3% versus 2.6%; P <0.001). In those with <2 risk factors, QRSA− patients had a low annual VA rate compared QRSA+ patients (0.58% versus 7.1%; P =0.001). Separate Cox models revealed QRSA+ (hazard ratio [HR], 2.9 [95% CI, 1.2–7.0]; P =0.019) and QRSA+/TWA− (HR, 7.9 [95% CI, 2.9–21.7]; P <0.001) as the most significant VA predictors. TWA and HCM risk factors did not predict VA. Conclusions In HCM, microvolt QRSA is a novel, rate‐dependent phenomenon that can exist without TWA and is associated with greater left ventricular thickness. QRSA increases VA risk 3‐fold in all patients, whereas the absence of QRSA confers low VA risk in patients with <2 risk factors. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02560844.


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