How Cardiomems Helped A Rider Control Her Heart Failure
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Intended Use: The Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are intended to provide ventricular antitachycardia pacing and ventricular cardioversion/defibrillation. The CRT-D devices are also intended to resynchronize the right and left ventricles.
The myMerlinPulse™ mobile application is intended for use by people who have an Abbott Medical implanted heart device and access to a mobile device. The app provides remote monitoring capability of the implanted heart device by transmitting information from the patient’s implanted heart device to the patient’s healthcare provider.
Indications: The ICD and CRT-D devices are indicated for automated treatment of life-threatening ventricular arrhythmias. CRT-D devices are also indicated to treat symptoms in patients who have congestive heart failure with ventricular dyssynchrony.
In addition, dual chamber ICD and CRT-D devices with the AT/AF detection algorithm are indicated in patients with atrial tachyarrhythmias or those patients who are at significant risk of developing atrial tachyarrhythmias.
MR Conditional ICDs and CRT-Ds are conditionally safe for use in the MRI environment when used in a complete MR Conditional system and according to instructions in the MRI-Ready Systems manual. Scanning under different conditions may result in severe patient injury, death or device malfunction.
The myMerlinPulse™ mobile application is indicated for use by patients with supported Abbott Medical implanted heart devices.
Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.
The myMerlinPulse™ mobile application is contraindicated for use with any implanted medical device other than supported Abbott Medical implanted heart devices.
Adverse Events: Possible adverse events associated with the implantation of the pulse generator system include the following: Arrhythmia (for example, accelerated or induced), Bradycardia, Cardiac or venous perforation, Cardiac tamponade, Cardiogenic shock, Death, Discomfort, Embolism, Endocarditis, Erosion, Exacerbation of heart failure, Excessive fibrotic tissue growth, Extracardiac stimulation (phrenic nerve, diaphragm, pectoral muscle), Extrusion, Fluid accumulation within the device pocket, Formation of hematomas, cysts, or seromas, Heart block, Hemorrhage, Hemothorax, Hypersensitivity, including local tissue reaction or allergic reaction, Infection,Keloid formation, Myocardial damage, Nerve damage, Occlusion/Thrombus, Pericardial effusion, Pericarditis, Pneumothorax, Pulmonary edema, Syncope, Thrombosis, Valve damage. Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage and rarely, death. Among the psychological effects of device implantation are imagined pulsing, depression, dependency, fear of premature battery depletion, device malfunction, inappropriate pulsing, shocking while conscious, or losing pulse capability. Possible adverse device effects include complications due to the following: , Abnormal battery depletion, Conductor fracture, Device-programmer communication failure, Elevated or rise in defibrillation/cardioversion threshold, Inability to defibrillate or pace, Inability to interrogate or program due to programmer or device malfunction, Incomplete lead connection with pulse generator, Inhibited therapy including defibrillation and pacing, Inappropriate therapy (for example, shocks and antitachycardia pacing [ATP] where applicable, pacing), Interruption of function due to electrical or magnetic interference, Intolerance to high rate pacing (for example dyspnea or discomfort), Lead abrasion, Lead fracture, Lead insulation damage, Lead migration or lead dislodgement, Loss of device functionality due to component failure, Pulse generator migration, Rise in DFT threshold, Rise in pacing threshold and exit block, Shunting of energy from defibrillation paddles, System failure due to ionizing radiation. Additionally, potential adverse events associated with the implantation of a coronary venous lead system include the following: Allergic reaction to contrast media, Breakage or failure of implant instruments, Prolonged exposure to fluoroscopic radiation, Renal failure from contrast media used to visualize coronary veins. Refer to the User’s Manual for detailed intended use, indications, contraindications, warnings, precautions and potential adverse events.
No potential adverse events have been identified with use of the myMerlinPulse™ mobile application.
† Competition defined as LV Only and BiV Simultaneous pacing modes. Modes 1 and IV of the referenced JAHA data.
‡ Fixed-tilt group of patients with competitive devices only achieved 83% success for maintaining a 10J safety margin
References:
1. Varma N, O’Donnell D, Bassiouny M, et al. Programming cardiac resynchronization therapy for electrical synchrony: reaching beyond left bundle branch block and left ventricular activation delay. J Am Heart Assoc. 2018;7:e007489.Http://jaha.Ahajournals.Org/content/7/3/e007489. Accessed April 17, 2018.
2. Wisnoskey BJ, Cranke G, Cantillon DJ, and Varma N. “Feasibility of Device-Based Electrical Optimization via Application of the Negative AV Hysteresis Algorithm during Cardiac Resynchronization Therapy (CRT).” Heart Rhythm. 2016; 13 (5S): S443.
3. Varma, N., Hu, Y., Connolly, A. T., Thibault, B., Singh, B., Mont, L., … & Zareba, W. (2021). Gain in realworld cardiac resynchronization therapy efficacy with SyncAV dynamic optimization: Heart failure hospitalizations and costs. Heart Rhythm.
4. Jastrzebski M, Baranchuk A, Fijorek K, Kisiel R, Kukla P, Sondej T, Czarnecka D. Cardiac resynchronization therapy-induced acute shortening of QRS duration predicts long-term mortality only in patients with left bundle branch block. Europace. 2019 Feb 1;21(2):281-289. Doi: 10.1093/europace/euy254. PMID: 30403774.
5. Based on over 560,000 episodes (20,000 patients). Performance of VF Therapy Assurance Feature. Abbott Clinical Summary.
6. Data on file. 60101422 Internal Validation Report. Total 2019 global high-voltage implants, all manufacturers, estimated to be 440,434 units (Source: Abbott Market Research).
7. Roland X. Stroobandt MD, PhD; Mattias F Duytschaever MD, PhD; Terest Strisciuglio MD; Frederic E.Van Heuverswyn MD; Liesbeth Timmers MD; Jan De Pooter MD, PhD; Sebastien Knecht MD, PhD; Yves R. Vanderkerckhove MD; Andreas Kucher PhD; Rene H. Tavernier MD, PhD. Failure to detect life-threatening arrhythmias in ICDs using single-chamber detection criteria. Pacing Clin Electrophysiology.2019;42:583-594. DOI:10.1111/pace.13610.3.
8. Gabriels J, Budzikowski AS, Kassotis JT. Defibrillation waveform duration adjustment increases the proportion of acceptable defibrillation thresholds in patients implanted with single-coil defibrillation leads. Cardiology. 2013;124(2):71.
Heart Failure: Not Part Of The Aging Process
By Marilyn A. Prasun, PhD, as told to Hope Cristol
I’ve worked to educate people about heart failure throughout my career as an advanced practice nurse practitioner, professor, and researcher. One of the major things I try to teach is the importance of seeing a doctor when you sense changes in your health.
There’s been so much progress with treatment and management of heart failure. But many people with heart failure symptoms wait longer than they should to get medical attention. I believe this is because the symptoms, such as shortness of breath and a decline in energy and endurance, happen gradually and are subtle. We often associate them with normal aging, so it’s easy to write them off: “Well, I’m getting older, that’s why I can’t walk or exercise like I used to.”
While heart failure happens most often to older people, it’s not a normal part of the aging process. In fact, heart failure often stems from long-term high blood pressure and coronary artery disease. Those also aren't normal parts of aging.
It’s important to know whether you have those or other health conditions that play a role in your heart failure. If you can address them, you’ll improve your health overall. Once you know more about the path that brought you to a heart failure diagnosis, you can also begin appropriate treatments.
In addition to medications and possibly device therapy, you most likely will need to make major changes to your diet and lifestyle. That can bring new challenges.
It takes a lot of commitment to follow a heart-healthy lifestyle, and it’s not always easy -- especially if you’re used to eating high-fat or salty foods. Often, a support system can make smart choices easier. Unfortunately, not everyone gets the support they need from the people around them. If your loved ones aren’t as understanding or encouraging as you need, you may want to consider finding other ways to get that support, such as from connections with other people living with heart failure.
This condition can change the dynamic of your relationships in a way that normal aging doesn’t. Because it’s an invisible disease and often poorly understood, your friends and family may not know what to make of your diagnosis. They may not understand your need to rest more often or why you need to make major changes to your lifestyle.
Also, when your loved ones hear the term heart failure, they can become very fearful. Or they can become overprotective in a way that could create problems, like if they try to limit your physical activity because of their own fears.
Sitting in a chair all day isn’t what people with heart failure need, and fear and anxiety isn’t what we want for their caregivers. That’s why patient and caregiver education has always been such a priority for me. There are many resources to help people manage all the ups and downs of life with heart failure, including support groups in person and online.
The advances I’ve seen in recent years have given me tremendous hope that people have the ability to lead long, full lives. It really requires commitment or, if you look at it another way, an unwillingness to let heart failure control your life.
You know, a lot of heart failure advice involves how to manage it after diagnosis. But really, the best treatment is prevention with a heart-healthy lifestyle. You can commit to healthy habits at any stage of life, but starting early can have a tremendous impact as we age. So many health problems can be prevented that way as well, including the heart conditions that can ultimately lead to heart failure.
WebMD Feature
SOURCE:
Marilyn A. Prasun, PhD, Decatur, IL.
How I’m Reducing My Heart Attack Risk – And You Can Too
My Bombay Mix and weekly chips habit needs a rethink. The main driver of prediabetes is weight, he tells me. Waist size matters. For women, post-menopause, when the gender advantage is slowly lost, the risk of a heart attack jumps. Over time, high blood sugar can damage blood vessels, the heart muscle directly as well as the kidneys.
“Your body becomes resistant to insulin with increases in weight, so even though you have normal blood sugar levels, the pancreas pumps out more insulin. That keeps blood sugar levels relatively normal, but as the levels creep up, the pancreas can’t produce enough, and you drift towards diabetes. The only way, really, is weight loss, ideally with diet and lifestyle changes, but medications if needed.”
The hard work starts. I’ve cut out sugar and learned to love zero-alcohol beer. As well as downloading a hypnosis app to target binge eating, I now cook from scratch. And I’ve invested in an Omron M4 Intelli IT blood pressure monitor that links to my phone and shoots up scarily after I have a bottle of wine with a friend in a restaurant.
The more alcohol you drink the higher the risk of developing hypertension (high blood pressure). It even admonishes me after a biscuit. Not only does sugar help pack on the pounds, but it independently impacts blood pressure.
Prof Ray still thinks I should still check out the root cause of my breathlessness. He advises I ask my GP for an echocardiogram (an ultrasound scan, which will tell me if the heart muscle and valves are OK, but a CT scan will be needed to see if I have furring in my arteries supplying the heart).
“With an increase in oxygen demand during exercise, the heart muscle has to work harder. If there is narrowing in the blood vessels, during exercise the supply of oxygen doesn’t match demand.”
I will always have a higher predisposition to heart attacks. I can’t change the genes, but I can change the environment and offset that vulnerability. “It’s like you’re at the top of a mountain ski slope,” says metaphor-loving Prof Ray. “You see the danger at the bottom. If you course-correct early you’re going to miss it by a mile. If you only see it with 10 metres to go, you’ll have to course-correct a lot.”
Talking of slopes, with my tweaked diet, I am finding hills easier. If I’ve learnt one lesson, it’s not to bury your head in the sand. Mike was frustrated with me because he’d like me to stay alive.
I owe it to my relatives to be more grown-up. They would have loved to have had my choices.
