Lights and shadows of implantable cardioverter defibrillators implantations in hypertrophic, dilated and arrhythmogenic right ventricular cardiomyopathies.
Posted: April 29, 2013 Filed under: Medical Devices, Opinions | Tags: bradycardia, defibrillator, eHealthcare, Health 2.0, ICD, implantable cardioverter defibrillators, lights, Medical Devices, pacemaker, SCD, sudden cardiac death Leave a commentIn the past decades, implantable cardioverter defibrillators (ICDs) have definitively proved to be superior to antiarrhythmic drugs for the prevention of arrhythmic sudden cardiac death (SCD). Several studies have proved this hypothesis both for primary or secondary (i.e. after a sustained ventricular tachycardia with hemodynamic compromise or ventricular fibrillation) prevention of SCD. However, some complications often occur with ICD implantation, which may be particularly serious for young individuals.
Indications for ICD implantation in young people are mostly ion channel diseases and cardiomyopathies. The latter are structural abnormalities of the myocardium, related to genetic abnormalities, predisposing to malignant ventricular arrhythmias and requiring ICD for the prevention of SCD in some cases.
Hypertrophic cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is one of the most common cardiomyopathies and occurs in the 0.2% of the general population1. It is characterized by localized asymmetrical hypertrophy of the heart and disarray of myocardial cells and filaments. This leads to impaired transmission of electrophysiologic impulses, with an unstable electrical substrate, potentially causing lethal ventricular tachyarrhythmias and SCD.
Short axis view of a cardiac magnetic resonance imaging of a patient affected by hypertrophic cardiomyopathy involving the interventricular septum and the anterior wall of the left ventricle.
ICD implantation in HCM: lights
A minority of patients with HCM are judged to be at increased risk for SCD, whose rate is estimated to be about 1% per year 2. However, malignant ventricular arrhythmias remains the most frequent cause of death in this population.
Beta-blockers have failed to demonstrate significant protection from SCD in HCM patients. Type I and III anti-arrhythmic drugs, including amiodarone, have been abandoned because of inefficacy and pro-arrhythmic side effects. Experiences with endocardial and epicardial mapping and ablation in HCM are poor and limited to highly selected patients.
ICDs, conversely, have been proved effective in terminating life-threatening ventricular tachyarrhythmias in HCM and are currently considered the only available tools altering the natural course of the disease and prolonging life.
Appropriate intervention rates of ICD in HCM have been esteemed to be about 11% and 4% for secondary and primary prevention respectively3.
Current recommendation for ICD in HCM
HCM has heterogeneous clinical manifestations in different individuals and a not well predictable clinical course. Targeting HCM-patients for prophylactic ICD implantation can therefore be challenging. However, some “risk factors” have been individuated, that commonly guide the decision for ICD implantation. Current international guidelines recommend ICD in all cases of secondary prevention or when familiar history of SCD, marked left ventricular (LV) hypertrophy or recent unexplained syncopal episodes are present. The role of ICD is uncertain for non-sustained VT or an abnormal blood pressure response with exercise.
ICD implantation in HCM: shadows
Previous studies have reported up to 5.1%/year rate of ICD-related complications in HCM4.
The most frequently reported is inappropriate shock delivery, mostly due to erroneous detection and treatment of atrial fibrillation by the ICD. A retrospective study on 334 consecutive HCM patients with an ICD, showed a rate of appropriate vs. inappropriate shock delivery of 2.3 and 4.6%/year5. Moreover, a recent meta-analysis involving 2190 ICD-recipients affected by HCM, showed a rate of appropriate vs. inappropriate ICD interventions of 3.3 vs. 4.8%/year respectively4.
Another extremely rare complication with ICDs in HCM, is represented by loss of capture due to high pacing thresholds (i.e. energy required for effective right ventricular pacing). This is related to ventricular hypertrophy and may be prevented by accurate individuation of the optimal pacing threshold during ICD programming.
Lengthened mitral valve leaflets, and left ventricular outflow tract obstruction due to LV hypertrophy, also confers a relatively higher risk of infection and endocarditis to HCM patients, which must be considered when an ICD implantation is programmed. Moreover, since ICD implantation in HCM is commonly performed at a relatively young age, patients are supposed to necessitate of a number of interventions for pulse generator substitution over their entire life. For this reason, risk of infection and endocarditis (related to ICD substitutions) is amplified. Eventual needing of ICD and intra-cardiac leads extraction over time must be considered. This is a high-risk procedure, possibly complicated by cardiac tamponade, shock, anemia, arrhythmias or even death.
Finally, ICD implantation can be accompanied by depression, anxiety, reduced quality of life, particularly in young people.
Idiopathic dilated cardiomyopathy
Idiopathic dilated cardiomyopathy (IDCM) is a myocardial disease characterized by LV dilation and systolic dysfunction, commonly resulting in heart failure (HF) and for whom an etiological basis cannot be identified. IDCM is relatively rare (36.5% new cases/year/100.000 persons) but accounts for nearly 10.000 deaths/year in the United States, both due to HF and arrhythmic SCD6.
Long axis view of a cardiac magnetic resonance imaging of a patient affected by dilated cardiomyopathy
ICD implantation in IDCM: lights
ICD are effective for the prevention of SCD in IDCM and can favorably alter the natural course of the disease. Previous studies have showed a rate of appropriate interventions of 5 to 7.5%/year in IDCM-patients with an ICD implanted for primary prevention 7-8. A large meta-analysis has showed a reduction of mortality with ICD of about 3.5%/year compared to the best medical therapy in IDCM 9.
Recommendation for ICD in IDCM
The most important risk factor for ventricular arrhythmias in primary prevention of SCD in IDCM, is represented by severe contractile dysfunction, quantified by the measurement of the ejection fraction (EF) at echocardiography. Functional status, assessed by the New York Heart Association (NYHA) class, also plays a role.
Current international guidelines recommend ICD always for secondary prevention. In case of primary prevention, ICD must be implanted in patients with LVEF ≤35% and NYHA class II and III10. However, in a real-life setting, the decision making for patients with IDCM is more complex, because issues such as additional cardiac resynchronization therapy (CRT), co-morbidities, the potential to improve LVEF over time, and eventual genetic etiology also should be considered. With regard to the last issue, carriers of mutations in gene encoding for laminin, are tough to be at increased risk of complete atrio-ventricular block, malignant ventricular arrhythmias and SCD, and may therefore require ICD implantation independently from the EF%.
ICD implantation in IDCM: shadows and warnings
Some shadows obscure the scenario of SCD prevention with ICDs in IDCM.
An important issue regards the high number of patients to be treated in order to save one life because of a currently adopted risk stratification process that appears to lack specificity.
Another topic is the correct timing for ICD implantation for primary prevention. A post hoc analysis of the DEFINITE trials 11 showed that only patients who had received their ICD not later than 3 months after the diagnosis of IDCM would have benefit from implant. However, a significant number of IDCM-individuals show marked improvement of the EF over time, up to values higher than those for which ICD implantation is currently recommended. The goal therefore, appears to be an early and correct individuation of those subjects who will have a negative clinical course, and will therefore require an early ICD implantation for primary prevention.
Similarly to HCM, ICD-related complications have been also reported by various studies, among whom:
- inappropriate shocks, with consequent reduction of quality of life;
- infections;
- risks related to eventual lead extractions;
- depression and anxiety.
Arrhythmogenic right ventricular cardiomyopathy
Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a genetic cardiomyopathy characterized by progressive fibro-fatty replacement of the right ventricular myocardium, sometimes extending also to the left ventricle. The clinical presentation is usually related to ventricular tachycardia (VT) with a left bundle branch block pattern or ventricular fibrillation (VF) leading to SCD. ARVC is a progressive disease ultimately leading to HF.
Panel A
Panel B
Short (Panel A) and long axis views (panel B) of a cardiac magnetic resonance imaging of a patient affected by arrhythmogenic right ventricular cardiomyopathy, with evident fibro-fatty replacement of the right ventricle wall, the apex and partial involvement of the left ventricle wall.
ICD implantation in ARVC: lights
The therapeutic options for ventricular arrhythmias in ARVC include catheter ablation and antiarrhythmic drugs such as beta blockers, sotalol and amiodarone. However, these strategies have proved to improve symptoms but not to increase survival. Nowadays, ICD remains the most effective safe-guard against SCD in ARVC.
In a large multicenter international study enrolling ARVC patients with an ICD implanted for primary prevention, appropriate device interventions were observed in one fourth of patients after 5 years. The annual rate of potentially “life-saving” shocks against VF was 3.3% and the estimated benefit of ICD implantation was of 23% after 2 years 12. Another recent prospective study enrolling a cohort of ARVC patients with an ICD implanted for primary prevention, reported appropriate device interventions in nearly one-half of individuals over a period of 4.7 years 13.
Recommendation for ICD in ARVC
As for IDCM and HCM, ICD implantation is recommended in ARVC for secondary prevention (aborted SCD, VF or hemodynamically unstable sustained VT). ICD is also recommended for primary prevention in patients with LVEF≤35%, severe right ventricular dilation and/or dysfunction, a syncopal episode suggestive for VT or VF or an affected family member with SCD. Other risk factors include: non-sustained VT, early onset of the disease and competitive sport activity.
ICD implantation in ARVC: shadows.
Several studies have proved a relatively high incidence of device-related complications in ARVC patients with an implanted ICD. In a study of 132 patients, five individuals required an additional lead because of pacing failure and one patient died from endocarditis secondary to device infection 14. Progression of fibro-fatty replacement of the myocardial tissue has been associated with high pacing thresholds and impedances and eventual loss of capture. Up to 37% lead-related complication in 7 years have been described in ARVC patients with an implanted ICD 15.
Considerations
The decision regarding ICD implantation is highly significant for any individual at risk of SCD. The clinical decision-making process itself is complex and imply consideration of a number of different aspects. Despite ICD is the only life-prolonging therapy in cardiomyopathies, eventually associated complications should be considered.
Modern technology, such as that utilized by NayaMed, has currently developed sophisticated algorithms allowing an accurate discrimination of supraventricular from ventricular arrhythmic episodes and properly guiding ICD therapies. A growing knowledge of those algorithms by the cardiologists would hopefully reduce the rate of inappropriately delivered shocks by ICDs.
Reliable RV lead alerts and RV lead integrity algorithms, also a constant automatic measurement of leads’ impedances and P, R Waves amplitude have also been implemented in the ICDs of NayaMed, preventing the problems caused by a lead failure. However, despite such algorithms, a complete abolition of ICD-related complications in cardiomyopathies is unreliable. Therefore, an accurate risk stratification appears necessary, as well as a careful weigh of the relative risks and benefits of ICD implantation in each individual.
Dr. Annamaria Martino
Dr. Leonardo Calo
Policlinico Casilino
Roma, Italy
References
1) Gersh J, Maron BJ, Bonow RO et al. 2011 ACCF/AHA Guideline for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy: A Report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2011; 58:e212-260
2) Maron BJ. Hypertrophic cardiomyopathy: a systematic review. JAMA 2002; 287:1308-1320
3) Maron BJ, Spirito B, Shen WK et al. Implantable cardioverter defibrillators and prevention of sudden cardiac death in hypertrophyc cardiomyopathy. JAMA 2007; 298: 405-412
4) O’Mahony C, Lambiase PD, Quarta G et al. The long-term survival and the risk and benefits of implantable cardioverter defibrillators in patients with hypertrophic cardiomyopathy. Heart 2012;98:116-125
5) Schinkel AF, Vriesendorp PA, Sijbrands EJ et al. Outcome and complications after implantable cardioverter defibrillator therapy in hypertrophic cardiomyopathy: systematic review and meta-analysis. Circ Heart Fail 2012;5:552-559
6) Codd MB, Sugrue DD, Gersh BJ et al. Epidemiology of idiopathic dilated and hypertrophic cardiomyopathy. A population based study in Olmsted County, Minnesota, 1975–1984. Circulation 1989;80:564–72
7) Bardy GH, Lee KL, Mark DB, Poole JE et al. Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005;352:225–237.
8) Kadish A, Dyer A, Daubert JP et al; Defibrillators in non-ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med 2004;350:2151–2158.
9) Desai AS, Fang JC, Maisel WH, Baughman KL. Implantable defibrillators for the prevention of mortality in patients with nonischemic cardiomyopathy: a meta-analysis of randomized controlled trial. JAMA 2004;292: 2874–287
10) Zipes DP; Camm AJ, Borggrefe M et al. ACC/AHA/ESC 2006. Guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Europace 2006; 8:746-837
11) Kadish A, Schaechter A, Subacius H et al. Patients with recently diagnosed nonischemic cardiomyopathy benefit from implantable cardioverter defibrillators. J Am Coll Cardiol 2006;47:2477–2482
12) Corrado D et al. Prophylactic Implantable Defibrillator in Patients With Arrhythmogenic Right Ventricular Cardiomyopathy/Dysplasia and No Prior Ventricular Fibrillation or Sustained Ventricular Tachycardia. Circulation. 2010;122:1144-1152.
13) Bhonsale A, James CA, Tichnell C et al. Incidence and predictors of implantable cardioverter-defibrillator therapy in patients with arrhythmogenic right ventricular dysplasia/ cardiomyopathy undergoing implantable cardioverter-defibrillator implantation for primary prevention. J Am Coll Cardiol, 2011;58:1485-96
14) Corrado D, Leoni L, Link MS et al. Implantable cardioverter-defibrillator therapy for prevention of sudden death in patients with arrhythmogenic right ventricular cardiomyopathy/dysplasia. Circulation 2003;108:3084–91.
15) Wichter T, Paul M,Wollmann C et al. Implantable cardioverter/defibrillator therapy in arrhythmogenic right ventricular cardiomyopathy. Single-center experience of long-term follow-up and complications in 60 patients. Circulation 2004;109:1503–8.
Thank you for visiting us at the ESC Congress 2012 in Munich
Posted: September 10, 2012 Filed under: NayaMed spirit | Tags: bradycardia, cardiac electrophysiology, cardiac techniques, congress, eHealthcare, ESC, Germany, Health 2.0, healthcare organizations, ICD, Medical Devices, Munich, pacemaker, pacemakers, video 4 CommentsNayaMed products in a few words
Posted: August 20, 2012 Filed under: Medical Devices | Tags: bradycardia, cardiac, cardiac electrophysiology, cardiac techniques, cardiology, conventional devices, defibrillator, eHealthcare, Health 2.0, ICD, Medical Devices, pacemaker, pacemakers, St Jude Medical, technical advisor Leave a commentAs a new appearance on the CRDM Market, customers often ask: “Who are you NayaMed?”, “What are your products and why should we chose you for our patients?”
Well, mostly because we offer a simple online platform with a permanent access to your products, giving full transparency and allowing permanent access to ordering, digital inventory, stock management access and technical support.
Also, because as a clinician, you get the product you need when you need. A product that has been designed and engineered to perfectly match the NayaMed philosophy – Smart and Simple.
We wanted the clinicians to be comfortable when using our devices, so we asked our Technical Advisors to present the NayaMed products in just a few minutes.
Mary Soranno and Marina Mancusi, our technical advisors for the UK and the Italian market did a wonderful job and we are inviting you to see a very brief, but complete presentation of our products in English or Italian.
English Version:
Italian Version:
NayaMed devices made simple. Watch it now!
Posted: August 13, 2012 Filed under: Medical Devices, Uncategorized | Tags: bradycardia, cardiac, cardiac electrophysiology, cardiac techniques, cardiology, conventional devices, defibrillator, eHealthcare, Health 2.0, healthcare applications, heart failure, ICD, Medical Devices, pacemaker, pacemakers, video Leave a commentMeet Mary Soranno, our technical advisor for the UK market presenting all the features of the NayaMed pacemakers & defibrillators. (Better than a long blog post or brochure!).
Job Offer: TECHNICAL ADVISOR GERMANY
Posted: December 2, 2011 Filed under: Job Posts | Tags: eHealthcare, Germany, Job post, Medical Devices, technical advisor Leave a commentLausanne – Switzerland – Permanent position
NayaMed is looking for a regional Technical Advisor. This role entails assisting electrophysiologists, cardiologists and clinicians in managing the programming of medical devices (pacemakers and defibrillators). As part of a centralized Care Center Unit, the Technical Advisor will work at the company’s headquarters.
Job description:
– Provide remote training of hospital staff on the medical device technologies
– Advise clinicians on device programming during implants, follow-up visits and troubleshooting situations
– Answer customers’ queries regarding technical issues, rapidly and precisely
– Help customers in managing product stock at hospital level using internal Inventory Management System
– Proactively contact the customers for training and helping them with new or changed features
– Play active role in the customer experience and collect info appropriately in the internal CRM system
– Support the sales process in relation to technical and administrative issues
– Animate community initiatives as an expert on the products
– Collaborate with the marketing team in order to develop new products and solutions, optimize processes at customer level
– Actively participate in internal and external education with technical and clinical literature
Who we are looking for:
– Higher education or degree in engineering, biomedical engineering degree preferred
– Other relevant background or education can be medical or paramedical
– Experience in medical devices, experience as a Technical Consultant in Cardiac Rhythm Management is a plus
– Spontaneous and friendly personality, service-minded
– Must be able to work well within a multicultural environment
– Must have excellent communication, interpersonal and computer skills
– Should be able to ameliorate customer service and all the staff’s skills
– Must be able to manage, use, and populate a knowledge database
– Good technology skills in relation with web support and unified communication
– Must be able to adapt well to change, enjoy working in a fast-paced environment
– Capacity and willingness to learn fast
– Should derive energy from helping others
– Fluency in German is mandatory; English and French would be seen as strong assets
If you are interested, please send your CV and cover letter to steve.forrer@nayamed.com
NayaMed Videos _ Making of!
Posted: November 29, 2011 Filed under: NayaMed spirit | Tags: eHealthcare, making-of, pacemakers, video Leave a commentMid-September this year, we had our first NayaMed videos production. This was quite an event!
We had the chance to have a special reporter from the inside that brought back awesome pictures that we want to share with you.
Here are the Video Director and our Chief Coordinator discussing the scenes.
Preparation of the scene. The scene represents a pacemaker follow-up visit at the hospital.
8:00 Everybody arrived.
10:30 We are preparing for the Pacemaker Follow-up shooting. The scene is explained to the actors. Last arrangements are made.
11:30 Follow-up scene is still ongoing… More explanations about how the doctor usually behaves.
11:55 A mobile phone rang… “No phones on this floor please!!!”
12:00 Done! The director is satisfied. It is time for a break before recording the next scene.
Below is one of the video that we shooted that day:
More NayaMed videos: here
To be or Not to be
Posted: November 23, 2011 Filed under: eHealthCare, Opinions | Tags: eHealthcare, sales representatives Leave a commentNayaMed is an online business company that sells medical devices (Pacemakers and Defibrillators) over European countries. The major difference with other medical companies is that NayaMed is focusing on services by leveraging the online (or web) technology. When products are excellent, high quality and life-saving, the focus relies on optimizing the purchasing and the traceability processes of our customers (hospital), because we cannot ignore the economic challenges that countries and health care systems are facing nowadays.
Does it make sense? Well, after reading the paragraph above, we can have the feeling customers, you, are going to be left alone behind only an Internet browser. Of course it is not the case. Of course without a close relationship with people it cannot be. Of course without a privileged customer care relationship nothing can last. Of course without a central team of experts no new services can exist.
NayaMed is deploying, in each country, NayaMed Account Representatives. Those AMs (as we called them) are the human touch of NayaMed. They are the guarantee that no customer is going to be left alone. Their activities are supported by the online services and by the strong presence of the central customer care organization that speaks your language.
This combination between online services and people close to you is the key to tackle down the spiral of cost. You see? As opposed to other medical companies today, we are redefining the role of people in the field by strictly focusing their activities on what does matter for customers and offering set of online services by allowing you to better manage orders and products traceability, to gain learning in product usage and to get on demand technical support.
So, To Be or Not to be? That’s not the question. NayaMed is, at least as a pioneer to show the route of the “digital” excellence.
Frederic Briguet
NayaMed Head of eBusiness