Procedure times, complication rates, and survival times associated with single-chamber versus dual-chamber pacemaker implantation in dogs with clinical signs of bradyarrhythmia: 54 cases (2004-2009).

PubMed

Genovese, David W; Estrada, Amara H; Maisenbacher, Herbert W; Heatwole, Bonnie A; Powell, Melanie A

2013-01-15

To compare procedure times and major and minor complication rates associated with single-chamber versus dual-chamber pacemaker implantation and with 1-lead, 2-lead, and 3-lead pacemaker implantation in dogs with clinical signs of bradyarrhythmia. Retrospective case series. 54 dogs that underwent pacemaker implantation because of clinical signs of bradyarrhythmia. Medical records of dogs that received pacemakers between July 2004 and December 2009 were reviewed for information regarding signalment, diagnosis, pacemaker implantation, pacemaker type, complications, and survival time. Analyses were performed to determine significant differences in anesthesia time, procedure time, and outcome for dogs on the basis of pacing mode and number of pacing leads. 28 of 54 (51.9%) dogs received single-chamber pacemakers and 26 (48.1%) received dual-chamber pacemakers. Mean ± SD procedural time was significantly longer for patients with dual-chamber pacemakers (133.5 ± 51.3 minutes) than for patients with single-chamber pacemakers (94.9 ± 37.0 minutes), and procedure time increased significantly as the number of leads increased (1 lead, 102.3 ± 51.1 minutes; 2 leads, 114.9 ± 24.8 minutes; 3 leads, 158.2 ± 8.5 minutes). Rates of major and minor complications were not significantly different between dogs that received single-chamber pacemakers and those that received dual-chamber pacemakers or among dogs grouped on the basis of the number of pacing leads placed. Although dual-chamber pacemaker implantation did result in increased procedural and anesthesia times, compared with single-chamber pacemaker implantation, this did not result in a higher complication rate.

Pacemaker lead fracture associated with weightlifting: a report of two cases.

PubMed

Deering, J A; Pederson, D N

1993-12-01

Two cases of pacemaker lead fracture associated with weight-lifting are presented. This is a rare association which has only recently been described in the literature. In both cases, the pacemaker lead was fractured between the clavicle and the first rib, suggesting crush injury. The chest X-ray, pacemaker telemetry with measurement of lead impedance, and pacemaker reprogramming were all helpful in management.

First percutaneous Micra leadless pacemaker implantation and tricuspid valve repair with MitraClip NT for lead-associated severe tricuspid regurgitation.

PubMed

Tang, Gilbert H L; Kaple, Ryan; Cohen, Martin; Dutta, Tanya; Undemir, Cenap; Ahmad, Hasan; Poniros, Angelica; Bennett, Joanne; Feng, Cheng; Lansman, Steven

2017-02-03

Pacemaker lead-associated severe tricuspid regurgitation (TR) can lead to right heart failure and poor prognosis. Surgery in these patients carries significant morbidities. We describe a successful treatment of symptomatic severe TR by leadless pacemaker implantation followed by tricuspid valve (TV) repair with the MitraClip NT. A 71-year-old frail female with poor functional status, chronic atrial fibrillation and permanent pacemaker implantation in 2012 presented with symptomatic moderate-severe mitral regurgitation (MR) and severe TR with the pacemaker lead as the culprit. She was deemed extreme risk for double valve surgery and, because of her pacemaker dependency, the decision was to stage her interventions first with transcatheter mitral repair, then laser lead extraction and leadless pacemaker implantation to free the TV from tethering, then TV repair. An obstructive LAD lesion was identified and treated during mitral repair with the MitraClip NT. The Micra leadless pacemaker implantation and subsequent TV repair with the MitraClip NT were successful and the patient's MR improved to mild and TR to moderate, respectively. We report here a first successful transcatheter strategy to treat lead-associated severe TR by leadless pacemaker and MitraClip. Removing the pacemaker lead relieved leaflet tethering and improved the reparability of the TV.

Tricuspid valve repair for severe tricuspid regurgitation due to pacemaker leads.

PubMed

Uehara, Kyokun; Minakata, Kenji; Watanabe, Kentaro; Sakaguchi, Hisashi; Yamazaki, Kazuhiro; Ikeda, Tadashi; Sakata, Ryuzo

2016-07-01

Tricuspid valve regurgitation due to pacemaker leads is a well-known complication. Although some reports have suggested that pacemaker leads should be surgically explanted, strongly adhered leads cannot always be removed. The aim of this study was to describe our tricuspid valve repair techniques with pacemaker leads left in situ. Our retrospective study investigated 6 consecutive patients who required tricuspid valve surgery for severe regurgitation induced by pacemaker leads. From the operative findings, we identified 3 patterns of tricuspid valve and pacemaker lead involvement. In 3 patients, the leads were caught in the chordae, in 2 patients, tricuspid regurgitation was caused by lead impingement on the septal leaflet, and in 3 patients, tricuspid valve leaflets had been perforated by the pacemaker leads. During surgery, all leads were left in situ after being separated from the leaflet or valvular apparatus. In addition, suture annuloplasty was performed for annular dilatation in all cases. In one patient, the lead was reaffixed to the annulus after the posterior leaflet was cut back towards the annulus, and the leaflet was then closed. There was one hospital death due to sepsis. The degree of tricuspid regurgitation was trivial in all surviving patients at discharge. During a mean follow-up of 21 months, one patient died from pneumonia 20 months after tricuspid valve repair. In patients undergoing tricuspid valve surgery due to severe tricuspid regurgitation caused by pacemaker leads, the leads can be left in situ after proper repair with annuloplasty. © The Author(s) 2016.

Pacemaker lead perforation of the right ventricle associated with Moraxella phenylpyruvica infection in a dog.

PubMed

Ciavarella, A; Nimmo, J; Hambrook, L

2016-04-01

A 13-year-old neutered male Border Collie was presented with acute onset syncope, weakness and anorexia 10 months after transvenous pacemaker implantation. The patient was laterally recumbent, bradycardic (36 beats/min) and febrile (40.7°C) on presentation. An electrocardiogram (ECG) revealed recurrence of third-degree atrioventricular block with a ventricular escape rhythm. Fluoroscopy identified migration of the pacemaker tip through the apex of the right ventricle. Echocardiography failed to reveal any evidence of pericardial effusion or cardiac tamponade. Full postmortem was performed after euthanasia. The pacemaker lead had perforated the apex of the right ventricle and lodged in the right pleural space. Culture of blood (taken antemortem), pericardial sac, right ventricular wall (surrounding pacemaker lead), pacemaker lead tip and pericardial fluid revealed a pure growth of Moraxella phenylpyruvica. Bacteraemia associated with M. phenylpyruvica has never been reported in the dog, but sporadic cases are reported in humans. Infection could have resulted from either pre-existing myocarditis or opportunistic infection and bacteraemia post pacemaker implantation. Evaluation of the pacemaker function at regular intervals would allow early detection of poor pacemaker-to-myocardium contact, which would prompt further investigation of pacemaker lead abnormalities such as perforation. © 2016 Australian Veterinary Association.

Permanent pacemaker lead induced severe tricuspid regurgitation in patient undergoing multiple valve surgery.

PubMed

Lee, Jung Hee; Kim, Tae Ho; Kim, Wook Sung

2015-04-01

Severe and permanent tricuspid regurgitation induced by pacemaker leads is rarely reported in the literature. The mechanism of pacemaker-induced tricuspid regurgitation has been identified, but its management has not been well established. Furthermore, debate still exists regarding the proper surgical approach. We present the case of a patient with severe tricuspid regurgitation induced by a pacemaker lead, accompanied by triple valve disease. The patient underwent double valve replacement and tricuspid valve repair without removal of the pre-existing pacemaker lead. The operation was successful and the surgical procedure is discussed in detail.

A Novel Way Of Repair Of Insulation Breaks During Pacemaker Generator Replacement

PubMed Central

Manzoor Ali, Syed; Iqbal, Khurshid; Tramboo, Nisar A; Lone, Aijaz A; Kaul, Suresh; Kaul, Neelam; Hafiz, Imran

2009-01-01

Minor abrasions can occur while mobilising old lead during pacemaker generator replacement necesittating placement of additional lead adding to the financial burden and junk in heart. We describe a novel way of repair of old pacemaker lead preventing additional lead placement. PMID:19763196

The pacemaker-twiddler's syndrome: an infrequent cause of pacemaker failure.

PubMed

Salahuddin, Mohammad; Cader, Fathima Aaysha; Nasrin, Sahela; Chowdhury, Mashhud Zia

2016-01-20

The pacemaker-twiddler's syndrome is an uncommon cause of pacemaker malfunction. It occurs due to unintentional or deliberate manipulation of the pacemaker pulse generator within its skin pocket by the patient. This causes coiling of the lead and its dislodgement, resulting in failure of ventricular pacing. More commonly reported among elderly females with impaired cognition, the phenomenon usually occurs in the first year following pacemaker implantation. Treatment involves repositioning of the dislodged leads and suture fixation of the lead and pulse generator within its pocket. An 87 year old Bangladeshi lady who underwent a single chamber ventricular pacemaker (VVI mode: i.e. ventricle paced, ventricle sensed, inhibitory mode) implantation with the indication of complete heart block, and presented to us again 7 weeks later, with syncopal attacks. She admitted to repeatedly manipulating the pacemaker generator in her left pectoral region. Physical examination revealed a heart rate of 42 beats/minute, blood pressure 140/80 mmHg and bilateral crackles on lung auscultation. She had no cognitive deficit. An immediate electrocardiogram showed complete heart block with pacemaker spikes and failure to capture. Chest X-ray showed coiled and retracted right ventricular lead and rotated pulse generator. An emergent temporary pace maker was set at a rate of 60 beats per minute. Subsequently, she underwent successful lead repositioning with strong counselling to avoid further twiddling. Twiddler's syndrome should be considered as a cause of pacemaker failure in elderly patients presenting with bradyarrythmias following pacemaker implantation. Chest X-ray and electrocardiograms are simple and easily-available first line investigations for its diagnosis. Lead repositioning is required, however proper patient education and counselling against further manipulation is paramount to long-term management.

Incidence of Bradycardia and Outcomes of Patients Who Underwent Orbital Atherectomy Without a Temporary Pacemaker.

PubMed

Lee, Michael S; Nguyen, Heajung; Shlofmitz, Richard

2017-02-01

We analyzed the incidence of bradycardia and the safety of patients with severely calcified coronary lesions who underwent orbital atherectomy without the insertion of a temporary pacemaker. The presence of severely calcified coronary lesions can increase the complexity of percutaneous coronary intervention due to the difficulty in advancing and optimally expanding the stent. High-pressure inflations to predilate calcified lesions may cause angiographic complications like perforation and dissection. Suboptimal stent expansion is associated with stent thrombosis and restenosis. Orbital atherectomy safely and effectively modifies calcified plaque to facilitate optimal stent expansion. The incidence of bradycardia in orbital atherectomy is unknown. Fifty consecutive patients underwent orbital atherectomy from February 2014 to September 2016 at our institution, none of whom underwent insertion of a temporary pacemaker. The final analysis included 47 patients in this retrospective study as 3 patients were excluded because of permanent pacemaker implantation. The primary endpoint was significant bradycardia, defined as bradycardia requiring emergent pacemaker placement or a heart rate <50 bpm at the end of atherectomy. The primary endpoint occurred in 4% of all patients, all driven by patients who experienced a heart rate decreasing to <50 bpm. The major adverse cardiac and cerebral event rate was 6%, driven by death (2%) and myocardial infarction (4%). No patient experienced target-vessel revascularization, stroke, or stent thrombosis. Angiographic complications included perforation in 2%, slow-flow in 4%, and flow-limiting dissection in 0%. Significant bradycardia was uncommon during orbital atherectomy. Performing orbital atherectomy without a temporary pacemaker appears to be safe.

Congestive heart failure caused by transvenous pacemaker lead prolapse and associated right ventricular outflow tract obstruction in a dog.

PubMed

Djani, D M; Coleman, A E; Rapoport, G S; Schmiedt, C W; Layher, J; Thomason, J D

2016-12-01

A 16-year-old dog was presented for cough as well as increased respiratory rate and effort three years after implantation of a single-lead transvenous artificial pacemaker system. Thoracic radiographs and echocardiography disclosed prolapse of the pacemaker lead into the main pulmonary artery, causing severe pulmonary insufficiency and right-sided volume overload. Repositioning of the pacemaker lead led to improvement of pulmonary insufficiency and resolution of the dog's clinical signs and cavitary effusions. This case describes a late complication of pacemaker implantation that may be avoided by appropriate use of the manufacturer-provided anchoring sleeve and avoidance of excessive lead redundancy. Copyright © 2016 Elsevier B.V. All rights reserved.

Impact of Pacemaker Lead Characteristics on Pacemaker Related Infection and Heart Perforation: A Nationwide Population-Based Cohort Study.

PubMed

Lin, Yu-Sheng; Chen, Tien-Hsing; Hung, Sheng-Ping; Chen, Dong Yi; Mao, Chun-Tai; Tsai, Ming-Lung; Chang, Shih-Tai; Wang, Chun-Chieh; Wen, Ming-Shien; Chen, Mien-Cheng

2015-01-01

Several risk factors for pacemaker (PM) related complications have been reported. However, no study has investigated the impact of lead characteristics on pacemaker-related complications. Patients who received a new pacemaker implant from January 1997 to December 2011 were selected from the Taiwan National Health Insurance Database. This population was grouped according to the pacemaker lead characteristics in terms of fixation and insulation. The impact of the characteristics of leads on early heart perforation was analyzed by multivariable logistic regression analysis, while the impact of the lead characteristics on early and late infection and late heart perforation over a three-year period were analyzed using Cox regression. This study included 36,104 patients with a mean age of 73.4±12.5 years. In terms of both early and late heart perforations, there were no significant differences between groups across the different types of fixation and insulations. In the multivariable Cox regression analysis, the pacemaker-related infection rate was significantly lower in the active fixation only group compared to either the both fixation (OR, 0.23; 95% CI, 0.07-0.80; P = 0.020) or the passive fixation group (OR, 0.26; 95% CI, 0.08-0.83; P = 0.023). There was no difference in heart perforation between active and passive fixation leads. Active fixation leads were associated with reduced risk of pacemaker-related infection.

Successful management of multiple permanent pacemaker complications – infection, 13 year old silent lead perforation and exteriorisation following failed percutaneous extraction, superior vena cava obstruction, tricuspid valve endocarditis, pulmonary embolism and prosthetic tricuspid valve thrombosis

PubMed Central

Kaul, Pankaj; Adluri, Krishna; Javangula, Kalyana; Baig, Wasir

2009-01-01

A 59 year old man underwent mechanical tricuspid valve replacement and removal of pacemaker generator along with 4 pacemaker leads for pacemaker endocarditis and superior vena cava obstruction after an earlier percutaneous extraction had to be abandoned, 13 years ago, due to cardiac arrest, accompanied by silent, unsuspected right atrial perforation and exteriorisation of lead. Postoperative course was complicated by tricuspid valve thrombosis and secondary pulmonary embolism requiring TPA thrombolysis which was instantly successful. A review of literature of pacemaker endocarditis and tricuspid thrombosis along with the relevant management strategies is presented. We believe this case report is unusual on account of non operative management of right atrial lead perforation following an unsuccessful attempt at percutaneous removal of right sided infected pacemaker leads and the incidental discovery of the perforated lead 13 years later at sternotomy, presentation of pacemaker endocarditis with a massive load of vegetations along the entire pacemaker lead tract in superior vena cava, right atrial endocardium, tricuspid valve and right ventricular endocardium, leading to a functional and structural SVC obstruction, requirement of an unusually large dose of warfarin postoperatively occasioned, in all probability, by antibiotic drug interactions, presentation of tricuspid prosthetic valve thrombosis uniquely as vasovagal syncope and isolated hypoxia and near instantaneous resolution of tricuspid prosthetic valve thrombosis with Alteplase thrombolysis. PMID:19239701

21 CFR 870.3620 - Pacemaker lead adaptor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker lead adaptor. 870.3620 Section 870.3620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3620 Pacemaker lead adaptor...

Leadless Cardiac Pacemaker Implantation After Lead Extraction in Patients With Severe Device Infection.

PubMed

Kypta, Alexander; Blessberger, Hermann; Kammler, Juergen; Lambert, Thomas; Lichtenauer, Michael; Brandstaetter, Walter; Gabriel, Michael; Steinwender, Clemens

2016-09-01

Conventional pacemaker therapy is limited by short- and long-term complications, most notably device infection. Transcatheter pacing systems (TPS) may be beneficial in this kind of patients as they eliminate the need for a device pocket and leads and thus may reduce the risk of re-infection. We assessed a novel procedure in 6 patients with severe device infection who were pacemaker dependent. After lead extraction a single chamber TPS was implanted into the right ventricle. Of the 6 patients who underwent lead extraction due to severe device infection at our institution, 3 were diagnosed with a pocket infection only, whereas the other 3 showed symptoms of both pocket and lead infection. Successful lead extraction and TPS implantation was accomplished in all patients. Four patients were bridged with a temporary pacemaker between 2 hours and 2 days after lead extraction, whereas 2 patients had the TPS implanted during the same procedure just before traditional pacemaker system removal. All patients stayed free of infection during the follow-up period of 12 weeks. An additional positron emission tomography scan was performed in each patient and indicated no signs of an infection around the TPS. Transcather pacemaker implantation was safe and feasible in 6 patients and did not result in re-infection even if implanted before removal of the infected pacemaker system within the same procedure. Therefore, implantation of a TPS may be an option for patients with severe device infection, especially in those with blocked venous access or who are pacemaker dependent. © 2016 Wiley Periodicals, Inc.

Rhabdomyosarcoma associated with the lead wire of a pacemaker generator implant.

PubMed

Thieman Mankin, Kelley M; Dunbar, Mark D; Toplon, David; Ginn, Pamela; Maisenbacher, Herbert W; Risselada, Marije

2014-06-01

An 11-year-old female spayed Labrador Retriever was presented for a draining, painful subcutaneous mass palpated over a previously implanted pacemaker generator. Infection was suspected and the mass was removed surgically. On cut surface, the mass was friable and mottled tan to brown with firm pale tan nodules, surrounding the pacemaker lead wire adjacent to the pacemaker generator. Cytologic interpretation of impression smears was consistent with a sarcoma, and suggestive of a rhabdomyosarcoma due to the presence of strap-like cells. On histopathologic examination, a highly invasive nodular mass surrounded the pacemaker lead, composed of pleomorphic round, spindle and strap cells, and multinucleated giant cells. The population exhibited microscopic invasion into the deep portion of the fibrous capsule surrounding the pacemaker generator. There were tumor emboli within small to medium subcutaneous veins adjacent to the mass. Immunohistochemically, the neoplastic cells stained positive for α-sarcomeric actin and vimentin, and negative for α-smooth muscle actin, consistent with a rhabdomyosarcoma arising at the site of the pacemaker generator. To our knowledge, this is the first report of a rhabdomyosarcoma associated with the lead wire of a pacemaker generator in a dog. © 2014 American Society for Veterinary Clinical Pathology and European Society for Veterinary Clinical Pathology.

Gene- and cell-based bio-artificial pacemaker: what basic and translational lessons have we learned?

PubMed Central

Li, RA

2012-01-01

Normal rhythms originate in the sino-atrial node, a specialized cardiac tissue consisting of only a few thousands of pacemaker cells. Malfunction of pacemaker cells due to diseases or aging leads to rhythm generation disorders (for example, bradycardias and sick-sinus syndrome (SSS)), which often necessitate the implantation of electronic pacemakers. Although effective, electronic devices are associated with such shortcomings as limited battery life, permanent implantation of leads, lead dislodging, the lack of autonomic responses and so on. Here, various gene- and cell-based approaches, with a particular emphasis placed on the use of pluripotent stem cells and the hyperpolarization-activated cyclic nucleotide-gated-encoded pacemaker gene family, that have been pursued in the past decade to reconstruct bio-artificial pacemakers as alternatives will be discussed in relation to the basic biological insights and translational regenerative potential. PMID:22673497

Gene- and cell-based bio-artificial pacemaker: what basic and translational lessons have we learned?

PubMed

Li, R A

2012-06-01

Normal rhythms originate in the sino-atrial node, a specialized cardiac tissue consisting of only a few thousands of nodal pacemaker cells. Malfunction of pacemaker cells due to diseases or aging leads to rhythm generation disorders (for example, bradycardias and sick-sinus syndrome (SSS)), which often necessitate the implantation of electronic pacemakers. Although effective, electronic devices are associated with such shortcomings as limited battery life, permanent implantation of leads, lead dislodging, the lack of autonomic responses and so on. Here, various gene- and cell-based approaches, with a particular emphasis placed on the use of pluripotent stem cells and the hyperpolarization-activated cyclic nucleotide-gated-encoded pacemaker gene family, that have been pursued in the past decade to reconstruct bio-artificial pacemakers as alternatives will be discussed in relation to the basic biological insights and translational regenerative potential.

Outcome and management of pacemaker-induced superior vena cava syndrome.

PubMed

Fu, Hai-Xia; Huang, Xin-Miao; Zhong, Li; Osborn, Michael J; Bjarnason, Haraldur; Mulpuru, Siva; Zhao, Xian-Xian; Friedman, Paul A; Cha, Yong-Mei

2014-11-01

We aimed to determine the long-term outcomes of percutaneous lead extraction and stent placement in patients with pacemaker-induced superior vena cava (SVC) syndrome. The study retrospectively screened patients who underwent lead extraction followed by central vein stent implantation at Mayo Clinic (Rochester, MN, USA), from January 2005 to December 2012, to identify the patients with pacemaker-induced SVC syndrome. Demographic, clinical, and follow-up characteristics of those patients were collected from electronic medical records. Six cases were identified. The mean (standard deviation) age was 56 (15) years (male, 67%). All patients had permanent dual-chamber pacemakers, with a mean 11-year history of pacemaker placement. The entire device system was explanted in five patients; one patient had a 21-year-old pacemaker lead that could not be removed. Eight stents were implanted in six patients: five patients had one stent, one patient had three. A new pacemaker system was reimplanted through the stented vein in five patients. Technical success was achieved in all patients, without any complication. Symptoms rapidly resolved in all patients after stent deployment. The mean follow-up duration was 48 months (range, 10-100 months). Three patients remained symptom free. Reintervention with percutaneous balloon venoplasty was successful in three patients with symptom recurrence. Percutaneous stent implantation after lead removal followed by reimplantation of leads is a feasible alternative therapy for pacemaker-induced SVC syndrome, although some cases may require repeat intervention. ©2014 Wiley Periodicals, Inc.

SU-E-T-802: Verification of Implanted Cardiac Pacemaker Doses in Intensity-Modulated Radiation Therapy: Dose Prediction Accuracy and Reduction Effect of a Lead Sheet

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, J; Chung, J

2015-06-15

Purpose: To verify delivered doses on the implanted cardiac pacemaker, predicted doses with and without dose reduction method were verified using the MOSFET detectors in terms of beam delivery and dose calculation techniques in intensity-modulated radiation therapy (IMRT). Methods: The pacemaker doses for a patient with a tongue cancer were predicted according to the beam delivery methods [step-and-shoot (SS) and sliding window (SW)], intensity levels for dose optimization, and dose calculation algorithms. Dosimetric effects on the pacemaker were calculated three dose engines: pencil-beam convolution (PBC), analytical anisotropic algorithm (AAA), and Acuros-XB. A lead shield of 2 mm thickness was designedmore » for minimizing irradiated doses to the pacemaker. Dose variations affected by the heterogeneous material properties of the pacemaker and effectiveness of the lead shield were predicted by the Acuros-XB. Dose prediction accuracy and the feasibility of the dose reduction strategy were verified based on the measured skin doses right above the pacemaker using mosfet detectors during the radiation treatment. Results: The Acuros-XB showed underestimated skin doses and overestimated doses by the lead-shield effect, even though the lower dose disagreement was observed. It led to improved dose prediction with higher intensity level of dose optimization in IMRT. The dedicated tertiary lead sheet effectively achieved reduction of pacemaker dose up to 60%. Conclusion: The current SS technique could deliver lower scattered doses than recommendation criteria, however, use of the lead sheet contributed to reduce scattered doses.Thin lead plate can be a useful tertiary shielder and it could not acuse malfunction or electrical damage of the implanted pacemaker in IMRT. It is required to estimate more accurate scattered doses of the patient with medical device to design proper dose reduction strategy.« less

Next-generation pacemakers: from small devices to biological pacemakers.

PubMed

Cingolani, Eugenio; Goldhaber, Joshua I; Marbán, Eduardo

2018-03-01

Electrogenesis in the heart begins in the sinoatrial node and proceeds down the conduction system to originate the heartbeat. Conduction system disorders lead to slow heart rates that are insufficient to support the circulation, necessitating implantation of electronic pacemakers. The typical electronic pacemaker consists of a subcutaneous generator and battery module attached to one or more endocardial leads. New leadless pacemakers can be implanted directly into the right ventricular apex, providing single-chamber pacing without a subcutaneous generator. Modern pacemakers are generally reliable, and their programmability provides options for different pacing modes tailored to specific clinical needs. Advances in device technology will probably include alternative energy sources and dual-chamber leadless pacing in the not-too-distant future. Although effective, current electronic devices have limitations related to lead or generator malfunction, lack of autonomic responsiveness, undesirable interactions with strong magnetic fields, and device-related infections. Biological pacemakers, generated by somatic gene transfer, cell fusion, or cell transplantation, provide an alternative to electronic devices. Somatic reprogramming strategies, which involve transfer of genes encoding transcription factors to transform working myocardium into a surrogate sinoatrial node, are furthest along in the translational pipeline. Even as electronic pacemakers become smaller and less invasive, biological pacemakers might expand the therapeutic armamentarium for conduction system disorders.

Infectious endocarditis in pacemaker endocardial leads: report of three cases.

PubMed

Cruz-Cruz, F; Espinola-Zavaleta, N; Hernández Lara, J; Iturralde-Torres, P; González-Hermosillo, J A; Romero-Cárdenas, A; Keirns, C; Vargas-Barrón, J

1999-01-01

Three cases of endocarditis affecting endocardial leads of permanent pacemakers are presented with a review of the literature. Vegetations were identified using transesophageal echocardiography. Infection of pacemaker leads is far less common than infection at the site of the pulse generator with greater morbidity and mortality and generally requiring surgical removal of both electrodes and power source. The most frequent infective agents are stahylococcus varieties.

Use of an Active-Fixation Coronary Sinus Lead to Implant a Biventricular Pacemaker via the Femoral Vein

PubMed Central

Shandling, Adrian; Donohue, Daniel; Tobias, Serge; Wu, Iris; Brar, Ramandeep

2010-01-01

Cardiac resynchronization therapy, which involves the placement of a pacing lead in the right atrium and in each ventricle, is effective in treating heart failure that is caused by left bundle branch block and cardiomyopathy. The left ventricular lead is usually placed into a lateral branch of the coronary sinus via the subclavian route. When the subclavian route is unavailable, insertion of a standard, passive-fixation coronary sinus lead via the femoral approach is feasible; however, the likelihood of subsequent dislodgment is high. Herein, we describe the placement of a novel, self-retaining, active-fixation coronary sinus lead—the Attain StarFix® Model 4195 OTW Lead—in an elderly heart-failure patient, via the femoral approach. We believe that this is the 1st report of this procedure. PMID:20200636

Permanent right ventricular pacing through an anomalous left superior vena cava.

PubMed Central

Amikam, S; Lemer, J; Riss, E

1977-01-01

A persistent left superior vena cava can complicate the implantation of a transvenous pacemaker. In a patient who required a permanent pacemaker, this venous anomaly was discovered during the insertion of the electrode but it did not prevent long-term right ventricular pacing. This was achieved after the electrode had been manipulated through the coronary sinus and right atrium. A plan of management is proposed for dealing with this unexpected problem. Images PMID:601745

Neck Pain One Week after Pacemaker Generator Replacement.

PubMed

Graham, Ross F; Wightman, John M

2015-07-01

The incidence of cardiac pacemaker implantation has risen markedly in the past three decades, making awareness of possible postprocedural complications critical to the emergency physician. This case is the first documented instance of internal jugular (IJ) deep vein thrombosis (DVT) from an uncomplicated pacemaker generator replacement. A patient presented to an Emergency Department with a 2-day history of mild left temporal headache migrating to his left neck. The patient did not volunteer this information, but review of systems revealed a temporary transvenous pacemaker inserted through the right IJ vein 1 week previously during a routine exchange of a left-sided cardiac pacemaker generator. Manipulation of the existing pacemaker wires entering the left subclavian vein was minimal. Computed tomographic angiography of the neck demonstrated near-complete thrombotic occlusion of the entire length of his left IJ vein. This required hospital admission for observation and treatment with anticoagulation. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: DVT, with thrombotic extension into adjacent vessels anywhere along the course of pacemaker wires, should be considered by the emergency provider in the evaluation of head, neck, or upper extremity symptoms after recent or remote implantation or manipulation of a transvenous cardiac pacemaker, including generator replacement. Failure to identify and treat appropriately could result in significant morbidity and mortality from airway edema, septic thrombophlebitis, superior vena cava syndrome, superior sagittal sinus thrombosis, or pulmonary embolism. Published by Elsevier Inc.

The challenge of staphylococcal pacemaker endocarditis in a patient with transposition of the great arteries endocarditis in congenital heart disease

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ch'ng, Julie; Chan, William; Lee, Paul

2003-06-01

Staphylococcus aureus is a leading cause of septicaemia and infective endocarditis. The overall incidence of staphylococcal bacteraemia is increasing, contributing to 16% of all hospital-acquired bacteraemias. The use of cardiac pacemakers has revolutionized the management of rhythm disturbances, yet this has also resulted in a group of patients at risk of pacemaker lead endocarditis and seeding in the range of 1% to 7%. We describe a 26-year-old man with transposition of the great arteries who had a pacemaker implanted and presented with S. aureus septicaemia 2 years postpacemaker implantation and went on to develop pacemaker lead endocarditis. This report illustratesmore » the risk of endocarditis in the population with congenital heart disease and an intracardiac device.« less

Outcomes of cardiac pacing in adult patients after a Fontan operation.

PubMed

Egbe, Alexander C; Huntley, Geoffery D; Connolly, Heidi M; Ammash, Naser M; Deshmukh, Abhishek J; Khan, Arooj R; Said, Sameh M; Akintoye, Emmanuel; Warnes, Carole A; Kapa, Suraj

2017-12-01

Cardiac pacing can be challenging after a Fontan operation, and limited data exist regarding pacing in adult Fontan patients. The objectives of our study were to determine risk factors for pacing and occurrence of device-related complications (DRCs) and pacemaker reinterventions. We performed a retrospective review of Fontan patients from 1994 through 2014. We defined DRCs as lead failure, lead recall, cardiac perforation, lead thrombus/vegetation, or device-related infection, and cardiovascular adverse events (CAEs) as venous thrombosis, stroke, death, or heart transplant. Pacemaker reintervention was defined as lead failure or recall. Of 439 patients, 166 (38%) had pacemakers implanted (79 during childhood; 87, adulthood); 114 patients (69%) received epicardial leads initially, and 52 (31%), endocardial leads. Pacing was initially atrial in 52 patients (31%); ventricular, 30 (18%); or dual chamber, 84 (51%). There were 37 reinterventions (1.9% per year) and 48 DRCs (2.4% per year). Pacemaker implantation during childhood was a risk factor for DRCs (hazard ratio, 2.01 [CI, 1.22-5.63]; P = .03). There were 70 CAEs (venous thrombosis, 5; stroke, 11; transplant, 8; and death, 46), yielding a rate of 3.5% per year. DRCs, CAEs, and reintervention rates were comparable for patients with epicardial or endocardial leads. More than one-third of adult Fontan patients referred to Mayo Clinic had pacemaker implantation. Epicardial leads were associated with high rate of pacemaker reinterventions but similar DRC rates in comparison to endocardial leads. Copyright © 2017 Elsevier Inc. All rights reserved.

Gene therapy to develop a genetically engineered cardiac pacemaker.

PubMed

Glenn, Christopher M; Pogwizd, Steven M

2003-01-01

While cardiac pacemakers are frequently used for the treatment of bradydysrhythmias (from diseases of the cardiac conduction system), their use is still limited by complications that can be life-threatening and expensive. Genetic engineering approaches offer an opportunity to modulate cellular automaticity in a manner that could have significant therapeutic potential. It is well known that ventricular myocytes exhibit a more negative diastolic potential than do pacemaker cells, in large part because of the inward rectifying potassium current/K1 (which pacemaker cells lack). Taking advantage of these intrinsic electrophysiological differences, a biological pacemaker has recently been developed by Miake et al (Nature 2002; 419:132-133) using adenoviral gene transfer approaches. By isolating the gene responsible for/K1 (the Kir2.1 gene), mutating it to make it a dysfunctional channel (a dominant-negative), inserting the mutated gene into an adenoviral vector, and delivering the virus to the hearts of guinea pigs, the investigators were able to successfully convert some ventricular myocytes to pacemaker cells. While issues of safety and long-term efficacy need to be further established, the results of these experiments provide proof of principle that gene transfer offers great promise for treatment of electrophysiological disorders including conduction system disease.

Cardiac MRI in patients with complex CHD following primary or secondary implantation of MRI-conditional pacemaker system.

PubMed

Al-Wakeel, Nadya; O h-Ici, Darach; Schmitt, Katharina R; Messroghli, Daniel R; Riesenkampff, Eugénie; Berger, Felix; Kuehne, Titus; Peters, Bjoern

2016-02-01

In patients with CHD, cardiac MRI is often indicated for functional and anatomical assessment. With the recent introduction of MRI-conditional pacemaker systems, cardiac MRI has become accessible for patients with pacemakers. The present clinical study aims to evaluate safety, susceptibility artefacts, and image reading of cardiac MRI in patients with CHD and MRI-conditional pacemaker systems. Material and methods CHD patients with MRI-conditional pacemaker systems and a clinical need for cardiac MRI were examined with a 1.5-T MRI system. Lead function was tested before and after MRI. Artefacts and image readings were evaluated using a four-point grading scale. A total of nine patients with CHD (mean age 34.0 years, range 19.5-53.6 years) received a total of 11 cardiac MRI examinations. Owing to clinical indications, seven patients had previously been converted from conventional to MRI-conditional pacemaker systems. All MRI examinations were completed without adverse effects. Device testing immediately after MRI and at follow-up showed no alteration of pacemaker device and lead function. Clinical questions could be addressed and answered in all patients. Cardiac MRI can be performed safely with high certainty of diagnosis in CHD patients with MRI-conditional pacemaker systems. In case of clinically indicated lead and box changing, CHD patients with non-MRI-conditional pacemaker systems should be considered for complete conversion to MRI-conditional systems.

Inadvertent positioning of pacemaker leads in the pericardium.

PubMed

Berenji, Kambeez; Nerheim, Pamela; Olshansky, Brian

2003-10-01

A patient had a dual chamber pacemaker with endocardial leads implanted chronically. The lead position on chest X ray and the ECG pattern indicated lead malposition, but a CT scan and transesophageal echocardiography were nondiagnostic. Venography indicated that both leads were in the mediastinal and pericardial space.

Automatic management of atrial and ventricular stimulation in a contemporary unselected population of pacemaker recipients: the ESSENTIAL Registry.

PubMed

Biffi, Mauro; Bertini, Matteo; Saporito, Davide; Belotti, Giuseppina; Quartieri, Fabio; Piancastelli, Maurizio; Pucci, Angelo; Boggian, Giulio; Mazzocca, Gian Franco; Giorgi, Davide; Diotallevi, Paolo; Diemberger, Igor; Martignani, Cristian; Pancaldi, Stefano; Ziacchi, Matteo; Marcantoni, Lina; Toselli, Tiziano; Attala, Simone; Iori, Matteo; Bottoni, Nicola; Argnani, Selina; Tomasi, Corrado; Sassone, Biagio; Boriani, Giuseppe

2016-10-01

We investigated the applicability of the Ventricular Capture Control (VCC) and Atrial Capture Control (ACC) algorithms for automatic management of cardiac stimulation featured by Biotronik pacemakers in a broad, unselected population of pacemaker recipients. Ventricular Capture Control and Atrial Capture Control were programmed to work at a maximum adapted output voltage as 4.8 V in consecutive recipients of Biotronik pacemakers. Ambulatory threshold measurements were made 1 and 12 months after pacemaker implant/replacement in all possible pacing/sensing configurations, and were compared with manual measurements. Among 542 patients aged 80 (73-85) years, 382 had a pacemaker implant and 160 a pacemaker replacement. Ventricular Capture Control could work at long term in 97% of patients irrespectively of pacing indication, lead type, and lead service life, performance being superior with discordant pacing/sensing configurations. Atrial Capture Control could work in 93% of patients at 4.8 V maximum adapted voltage and at any pulse width, regardless of pacing indication, lead type, and service life. At 12-month follow-up, a ventricular threshold increase ≥1.5 V had occurred in 4.4% of patients uneventfully owing to VCC functioning. Projected pacemaker longevity at 1 month was strongly correlated with the 12-month estimate, and exceeded 13 years in >60% of patients. These algorithms for automatic management of pacing output ensure patient safety in the event of a huge increase of pacing threshold, while enabling maximization of battery longevity. Their applicability is quite broad in an unselected pacemaker population irrespectively of lead choice and service of life. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

Pacemakers and implantable cardioverter defibrillators--general and anesthetic considerations.

PubMed

Rapsang, Amy G; Bhattacharyya, Prithwis

2014-01-01

A pacemaking system consists of an impulse generator and lead or leads to carry the electrical impulse to the patient's heart. Pacemaker and implantable cardioverter defibrillator codes were made to describe the type of pacemaker or implantable cardioverter defibrillator implanted. Indications for pacing and implantable cardioverter defibrillator implantation were given by the American College of Cardiologists. Certain pacemakers have magnet-operated reed switches incorporated; however, magnet application can have serious adverse effects; hence, devices should be considered programmable unless known otherwise. When a device patient undergoes any procedure (with or without anesthesia), special precautions have to be observed including a focused history/physical examination, interrogation of pacemaker before and after the procedure, emergency drugs/temporary pacing and defibrillation, reprogramming of pacemaker and disabling certain pacemaker functions if required, monitoring of electrolyte and metabolic disturbance and avoiding certain drugs and equipments that can interfere with pacemaker function. If unanticipated device interactions are found, consider discontinuation of the procedure until the source of interference can be eliminated or managed and all corrective measures should be taken to ensure proper pacemaker function should be done. Post procedure, the cardiac rate and rhythm should be monitored continuously and emergency drugs and equipments should be kept ready and consultation with a cardiologist or a pacemaker-implantable cardioverter defibrillator service may be necessary. Copyright © 2013 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

Pacemaker Implantation Associated Myocardial Micro-Damage: A Randomised Comparison between Active and Passive Fixation Leads.

PubMed

Blažek, Patrick; Ferri-Certić, Jerko; Vražić, Hrvoje; Lennerz, Carsten; Grebmer, Christian; Kaitani, Kazuaki; Karch, Martin; Starčević, Boris; Semmler, Verena; Kolb, Christof

2018-03-20

Fixation of the pacemaker leads during pacemaker implantation leads to an increase of cardiac Troponin T (cTnT) that can be interpreted as a sign of minimal myocardial damage. This trial evaluates whether the mechanism type of lead fixation influences the magnitude of cTnT release. Patients having a de-novo cardiac pacemaker implantation or a lead revision were centrally randomized to receive either a ventricular lead with an active (screw) or passive (tine) fixation mechanism. High-sensitive Troponin T (hsTnT) was determined on the day of the procedure beforehand and on the following day. 326 Patients (median age (IQR) 75.0 (69.0-80.0) years, 64% male) from six international centers were randomized to receive ventricular leads with an active (n = 166) or passive (n = 160) fixation mechanism. Median (IQR) hsTnT levels increased by 0.009 (0.004-0.021) ng/ml in the group receiving screw-in ventricular leads and by 0.008 (0.003-0.030) ng/ml in the group receiving tined ventricular leads (n.s.). In conclusion pacemaker implantations are followed by a release of hsTnT. The choice between active or passive fixation ventricular leads does not have a significant influence on the extent of myocardial injury and the magnitude of hsTnT release.

Percutaneous tricuspid valvotomy for pacemaker lead-induced tricuspid stenosis

PubMed Central

Patil, Devendra V.; Nabar, Ashish A.; Sabnis, Girish R.; Phadke, Milind S.; Lanjewar, Charan P.; Kerkar, Prafulla G.

2015-01-01

Permanent pacemaker lead-induced tricuspid regurgitation is extremely uncommon. We report a patient with severe tricuspid stenosis detected 10 years after permanent single chamber pacemaker implantation in surgically corrected congenital heart disease. The loop at the level of the tricuspid valve may have caused endothelial injury and eventually led to stenosis. Percutaneous balloon valvotomy for such stenosis has not been reported from India. PMID:26995417

[Auricular arrhythmia in Steinert's myotonia. Apropos of a case with a familial study].

PubMed

Chagnon, A; Vidal, M E

1983-02-24

A case of bradycardia-tachycardia syndrome leading to the late discovery of Steinert syndrome is reported. There is a discrepancy between the frequency of the main features of the bradycardia-tachycardia syndrome (sinoatrial block and atrial flutter in our observation) usually reported in Steinert disease and the fact that no case similar to ours seems to have yet been reported; this suggests definite underrating. Insertion of a pacemaker should avoid sudden death from a conduction disturbance. The heart should be carefully monitored in patients with myotonic dystrophy; conversely, this diagnosis should be considered in the etiologic diagnosis of myocardiopathies.

Medial subclavicular musculotendinous complex and insulation break: Rare cause of late pacemaker lead malfunction

PubMed Central

Bhattacharyya, Pranab Jyoti; Agrawal, Shweta; Barkataky, Jogesh Chandra; Bhattacharyya, Anjan Kumar

2015-01-01

Insulation break in a permanent pacemaker lead is a rare long-term complication. We describe an elderly male with a VVIR pacemaker, who presented with an episode of presyncope more than 3 years after the initial implantation procedure, attributed to insulation break possibly caused by lead entrapment in components of the medial subclavicular musculotendinous complex (MSMC) and repeated compressive damage over time during ipsilateral arm movement requiring lead replacement. The differential diagnosis of a clinical presentation when pacing stimuli are present with failure to capture and the role of the MSMC in causing lead damage late after implantation are discussed. PMID:26995445

Acute pericarditis with cardiac tamponade induced by pacemaker implantation.

PubMed

Shingaki, Masami; Kobayashi, Yutaka; Suzuki, Haruo

2015-11-01

An 87-year-old woman was diagnosed with third-degree atrioventricular block and underwent pacemaker implantation. On postoperative day 12, she experienced cardiac tamponade that was suspected on computed tomography to be caused by lead perforation; therefore, we performed open-heart surgery. However, we could not identify a perforation site on the heart, and drained a 400-mL exudative pericardial effusion. Subsequently, we diagnosed the pericardial effusion as due to pericarditis induced by pacemaker implantation. It is sometimes difficult to distinguish pericarditis from pacemaker lead perforation, so both should be included in the differential diagnosis. © The Author(s) 2014.

Permanent epicardial pacing in pediatric patients: 12-year experience at a single center.

PubMed

Kwak, Jae Gun; Kim, Soo-Jin; Song, Jin Young; Choi, Eun Young; Lee, Sang Yoon; Shim, Woo Sup; Lee, Chang-Ha; Lee, Cheul; Park, Chun Soo

2012-02-01

Permanent cardiac pacing is not often done in children, and when done is usually accomplished through epicardial pacing. We reviewed a 12-year experience with the implantation of epicardial pacemakers by our clinical group. Fifty-three patients who underwent their first implantation of an epicardial pacemaker before the age of 18 years and between 1997 and 2009 were included in our study. The mean age of the patients at the time of first pacemaker implantation was 5.7±4.8 years. Indications for pacemaker implantation included postoperative or congenital atrioventricular block and sinus node dysfunction. The patients underwent 105 operations for the replacement of pacemaker pulse generators and 75 operations for the replacement of pacemaker leads. The most commonly used generator mode was the rate-responsive accelerometer-based (DDDR) mode, which was used in 40.9% of the patients. We used more non-steroid-eluting leads (70.1%) than steroid-eluting leads (29.1%). The overall duration of follow-up in the study was 8.0±4.5 years (range, 2.1 months to approximately 17.0 years). Freedom from the need for generator replacement was 98.0%, 60.7%, and 11.1% at 1, 5, and 8 years, respectively. A tendency toward early generator exhaustion was observed among younger patients (p=0.058). The generator mode used for pacing did not significantly affect generator longevity. Freedom from the need for lead replacement was 98.3%, 83.8%, and 63.6% at 1, 5, and 10 years, respectively. The mean longevity of the leads used in the study was 10.8±0.8 years. Neither patient age at the time of lead implantation nor type of lead significantly affected lead longevity. Lead longevity was sufficiently long and did not vary significantly according to type of lead. Generator longevity was not affected by lead type, generator mode, or patient age at the time of pacemaker implantation. Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Aggregatibacter aphrophilus pacemaker endocarditis: a case report.

PubMed

Patel, Sahil R; Patel, Nishi H; Borah, Amit; Saltzman, Heath

2014-12-08

Aggregatibacter bacteria are a rare cause of endocarditis in adults. They are part of a group of organisms known as HACEK--Haemophilus, Aggregatibacter, Cardiobacter, Eikenella, and Kingella. Among these organisms, several Haemophilus species have been reclassified under the genus Aggregatibacter. Very few cases of Aggregatibacter endocarditis in patients with pacemaker devices have been reported. We present here what we believe to be the first case of Aggregatibacter aphrophilus pacemaker endocarditis. A 62-year-old African American male with a medical history significant for dual-chamber pacemaker placement in 1996 for complete heart block with subsequent lead manipulation in 2007, presented to his primary care doctor with fever, chills, night sweats, fatigue, and ten-pound weight loss over a four-month period. Physical examination revealed a new murmur and jugular venous distension which prompted initiation of antibiotics for suspicion of endocarditis. Both sets of initial blood cultures were positive for A. aphrophilus. Transesophageal echocardiogram revealed vegetations on the tricuspid valve and the right ventricular pacemaker lead (Figure 1). This case highlights the importance of identifying rare causes of endocarditis and recognizing that treatment may not differ from the standard treatment for typical presentations. The patient received intravenous ceftriaxone for his endocarditis for a total of six weeks. Upon device removal, temporary jugular venous pacing wires were placed. After two weeks of antibiotic treatment and no clinical deterioration, a new permanent pacemaker was placed and the patient was discharged home. This is the first case of A. aphrophilus endocarditis in a patient with a permanent pacemaker. Our patient had no obvious risk factors other than poor dentition and a history of repeated pacemaker lead manipulation. This suggests that valvulopathies secondary to repeated lead manipulation can be clinically significant factors in morbidity and mortality in this patient population.

Management of central venous gradient using excimer laser lead extraction of chronic indwelling pacemaker leads in the setting of ipsilateral arteriovenous fistula.

PubMed

Ramirez, Alexies; Gentlesk, Philip J; Peele, Mark E; Eckart, Robert E

2012-07-01

Device therapy is becoming common in those patients with renal insufficiency. Coexisting need for arteriovenous (AV) fistula placement is often contemplated relative to device placement. We describe the excimer laser lead extraction of a malfunctioning chronic atrial pacemaker lead ipsilateral to an AV fistula.

Effect of monopolar radiofrequency energy on pacemaker function.

PubMed

Govekar, Henry R; Robinson, Thomas N; Varosy, Paul D; Girard, Guillaume; Montero, Paul N; Dunn, Christina L; Jones, Edward L; Stiegmann, Greg V

2012-10-01

This study aimed to quantify the clinical parameters of mono- and bipolar instruments that inhibit pacemaker function. The specific aims were to quantify pacer inhibition resulting from the monopolar instrument by altering the generator power setting, the generator mode, the distance between the active electrode and the pacemaker, and the location of the dispersive electrode. A transvenous ventricular lead pacemaker overdrive paced the native heart rate of an anesthetized pig. The primary outcome variable was pacer inhibition quantified as the number of beats dropped by the pacemaker during 5 s of monopolar active electrode activation. Lowering the generator power setting from 60 to 30 W decreased the number of dropped paced events (2.3 ± 1.2 vs 1.6 ± 0.8 beats; p = 0.045). At 30 W of power, use of the cut mode decreased the number of dropped paced beats compared with the coagulation mode (0.6 ± 0.5 vs 1.6 ± 0.8; p = 0.015). At 30 W coagulation, firing the active electrode at different distances from the pacemaker generator (3.75, 7.5, 15, and 30 cm) did not change the number of dropped paced beats (p = 0.314, analysis of variance [ANOVA]). The dispersive electrode was placed in four locations (right/left gluteus, right/left shoulder). More paced beats were dropped when the current vector traveled through the pacemaker/leads than when it did not (1.5 ± 1.0 vs 0.2 ± 0.4; p < 0.001). Clinical parameters that reduce the inhibition of a pacemaker by monopolar instruments include lowering the generator power setting, using cut (vs coagulation) mode, and locating the dispersive electrode so the current vector does not traverse the pacemaker generator or leads.

Reducing RF-related heating of cardiac pacemaker leads in MRI: implementation and experimental verification of practical design changes.

PubMed

Nordbeck, Peter; Fidler, Florian; Friedrich, Michael T; Weiss, Ingo; Warmuth, Marcus; Gensler, Daniel; Herold, Volker; Geistert, Wolfgang; Jakob, Peter M; Ertl, Georg; Ritter, Oliver; Ladd, Mark E; Bauer, Wolfgang R; Quick, Harald H

2012-12-01

There are serious concerns regarding safety when performing magnetic resonance imaging in patients with implanted conductive medical devices, such as cardiac pacemakers, and associated leads, as severe incidents have occurred in the past. In this study, several approaches for altering an implant's lead design were systematically developed and evaluated to enhance the safety of implanted medical devices in a magnetic resonance imaging environment. The individual impact of each design change on radiofrequency heating was then systematically investigated in functional lead prototypes at 1.5 T. Radiofrequency-induced heating could be successfully reduced by three basic changes in conventional pacemaker lead design: (1) increasing the lead tip area, (2) increasing the lead conductor resistance, and (3) increasing outer lead insulation conductivity. The findings show that radiofrequency energy pickup in magnetic resonance imaging can be reduced and, therefore, patient safety can be improved with dedicated construction changes according to a "safe by design" strategy. Incorporation of the described alterations into implantable medical devices such as pacemaker leads can be used to help achieve favorable risk-benefit-ratios when performing magnetic resonance imaging in the respective patient group. Copyright © 2012 Wiley Periodicals, Inc.

A rare, late complication after automated implantable cardioverter-defibrillator placement.

PubMed

Shapiro, Michael; Hanon, Sam; Schweitzer, Paul

2004-10-01

This article describes an interesting case of automated implantable cardioverter defibrillator (AICD) extrusion fifteen months after implantation. The case report is followed by a discussion of the causes and treatment of skin erosion following pacemaker/AICD insertion.

Complications of pacemaker therapy in adults with congenital heart disease: a multicenter study.

PubMed

Opić, Petra; van Kranenburg, Matthijs; Yap, Sing-Chien; van Dijk, Arie P; Budts, Werner; Vliegen, Hubert W; van Erven, Lieselot; Can, Anil; Sahin, Gulhan; Theuns, Dominic A M J; Witsenburg, Maarten; Roos-Hesselink, Jolien W

2013-10-09

This study aims to investigate indications and complications of permanent cardiac pacing in adults with congenital heart disease (CHD). Two-hundred and seventy-four CHD patients were identified who underwent permanent pacemaker implantation between 1972 and 2009. The indication for pacing was acquired sinus node or AV node conduction disease (63%), sinus node or AV node conduction disease after cardiac surgery (28%), and drug/arrhythmia-related indications (9%). Patients with complex CHD received a pacemaker at younger age (23 versus 31 years, p<0.0001) and more often received an epicardial pacing system (51% versus 23%, p<0.0001) compared to those with simple or moderate CHD. Twenty-nine patients (10.6%) had a periprocedural complication during the primary pacemaker implantation (general population: 5.2%). The most common acute complications were lead dysfunction (4.0%), bleeding (2.6%), pocket infection (1.5%) and pneumothorax (1.5%). During a median follow-up of 12 years, pacemaker-related complications requiring intervention occurred in 95 patients (34.6%). The most common late pacemaker-related complications included lead failure (24.8%), pacemaker dysfunction/early battery depletion (5.1%), pacemaker migration (4.7%) and erosion (4.7%). Pacemaker implantation at younger age (<18 years) was an independent predictor of late pacemaker-related complication (adjusted hazard ratio 1.68, 95% confidence interval 1.07 to 2.63, p=0.023). The risk of periprocedural complications seems higher in the CHD population compared to the general population and more than one-third of CHD patients encountered a pacemaker-related complication during long-term follow-up. This risk increases for those who receive a pacemaker at younger age. Crown Copyright © 2013. Published by Elsevier Ireland Ltd. All rights reserved.

The nuclear pacemaker: Is renewed interest warranted

DOE Office of Scientific and Technical Information (OSTI.GOV)

Parsonnet, V.; Berstein, A.D.; Perry, G.Y.

1990-10-01

From 1973 through 1987, 155 radioisotope-powered nuclear pacemakers were implanted in 132 patients at the Newark Beth Israel Medical Center. The longevity of the first 15 devices, all of which were fixed-rate (VOO) pacemakers, was significantly better than that of 15 lithium-chemistry demand (VVI) pacemakers used as control devices (p = 0.0002). Of the entire cohort of 155 nuclear pacemakers, 136 were VVI devices and 19 were VOO units. The patients with VOO pacemakers needed reoperations more often than did those with VVI pacemakers, chiefly for mode change (p less than 0.001). Power-source failure was observed in only 1 case,more » but 47 nuclear pacemakers were removed for other reasons, including component malfunction (15 units), mode change (12 units), high pacing thresholds (8 units) and lead or connector problems (5 units). The actuarial survival at 15 years was 99% for power sources and 82% for the entire pacing systems (pulse generators plus leads). The frequency of malignancy was similar to that of the population at large and primary tumor sites were randomly distributed. Deaths most commonly were due to cardiac causes (68%). Thus, nuclear pacemakers are safe and reliable and their greater initial cost appears to be offset by their longevity and the resulting decrease in the frequency of reoperations. It is reasonable to suggest that further use be made of long-lasting nuclear power sources for modern pacemakers and other implantable rhythm-management devices.« less

Design, fabrication and characterization of a very low frequency piezoelectric energy harvester designed for heart beat vibration scavenging

NASA Astrophysics Data System (ADS)

Colin, M.; Basrour, S.; Rufer, L.

2013-05-01

Current version of implantable cardioverter defibrillators (ICDs) and pacemakers consists of a battery-powered pulse generator connected onto the heart through electrical leads inserted through the veins. However, it is known that long-term lead failure may occur and cause a dysfunction of the device. When required, the removal of the failed leads is a complex procedure associated with a potential risk of mortality. As a consequence, the main players in the field of intracardiac implants prepare a next generation of devices: miniaturized and autonomous leadless implants, which could be directly placed inside the heart. In this paper, we discuss the frequency content of a heart vibration spectrum, and the dimensional restrictions in the case of a leadless pacemaker. In combination with the requirements in terms of useable energy, we will present a design study of a resonant piezoelectric scavenger aimed at powering such a device. In particular, we will show how the frequency-volume-energy requirement leads to new challenges in terms of power densities, which are to be addressed through implementation of innovative piezoelectric thick films fabrication processes. This paper also presents the simulation, fabrication and the testing of an ultralow frequency (15Hz) resonant piezoelectric energy harvester prototype. Using both harmonic (50mg) and real heart-induced vibrations, we obtained an output power of 60μW and 10μW respectively. Finally, we will place emphasis on the new constraint represented by the gravitational (orientation) sensitivity inherent to these ultra low frequency resonant energy harvesters.

[Heart failure provoked by a pacemaker lead-induced tricuspid stenosis].

PubMed

Chaudesaygues, E; Ferrini, M; Ritz, B

2017-04-01

Tricuspid stenosis (TS) is an uncommon complication of ventricular pacemaker implantation. Mechanisms described by the literature are ventricular inflow obstruction by tricuspid vegetations (endocarditis) or multiple pacemaker leads and fibrosis secondary to mechanical trauma, accounting for perforation or laceration of the TV leaflets, or adherence between redundant loops and valve tissue. We present the case of iatrogenic tricuspid stenosis, observed in a 77-year-old man. Extrinsic tricuspid valve stenosis was detected by transthoracic echocardiography. Further investigations confirmed the intramyocardial lead position. Tricuspid valve stenosis due to transvenous leads are reported to be treated by surgical replacement, surgical valvuloplasty, or percutaneous balloon valvuloplasty. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Clinical Profile and Early Complications after Single and Dual Chamber Permanent Pacemaker Implantation at Manmohan Cardiothoracic Vascular and Transplant Centre, Kathmandu, Nepal.

PubMed

Khanal, J; Poudyal, R R; Devkota, S; Thapa, S; Dhungana, R R

2015-01-01

Permanent pacemaker implantation is a minimally invasive surgical procedure in the management of patients with cardiac problems. However, complications during and after implantation are not uncommon. There is lack of evidences in rate of complications with the selection of pacemakers in Nepal. Therefore, this study was performed to compare the frequency of implantation and complication rate between single chamber and dual chamber pacemaker. The present study is based on all consecutive pacemaker implantations in a single centre between April 2014 and May 2015. A total of 116 patients were categorized into two cohorts according to the type of pacemaker implanted- single chamber or dual chamber. All patients had regular 2-weeks follow-up intervals with standardized documentation of all relevant patient data till 6-week after implantation. Data were presented as means ± standard deviation (SD) for continuous variables and as proportions for categorical variables. Comparison of continuous variables between the groups was made with independent Student's t-test. For discrete variables distribution between groups were compared with Chi-square test. The mean age (±SD) of total population at implant was 64.08 (± 15.09) years. Dual chamber units were implanted in 44 (37.93%) of patients, single chamber in 72 (62.06%). Only 14 women (31.81%) received dual chamber compared with 42 women (58.33%) who received single chamber (Chi-square=18, DF=1, P = 0.0084). Complete atrioventricular block was the commonest (56.03%) indication for permanent pacemaker insertion followed by sick sinus syndrome (33.62%), symptomatic high-grade AV block (11.20%). Hypertension (dual chamber 21.55%, single chamber 40.51%) was the most common comorbidity in both cohorts. Complications occurred in 11 (9.48%) patients. More proportion of complication occurred in single chamber group (9 patients, 12.50%) than in dual chamber (2 patients, 4.54%). Complications occurring in dual chamber group include pocket hematoma 1 patient (2.27%) and arrhythmia in 1 patient (2.27%). Similarly, complications occurring in single chamber include RV perforation in two patients (2.77%) and one each (1.38%) had pocket hematoma, pneumothorax, infection, swelling at pocket site, arrhythmia in the form of NSVT, leads displacement, DVT and mortality. Women were more likely to receive single chamber systems than men. More proportion of complication occurred in single chamber group than in dual chamber. Future prospective studies on larger number of patients are needed to confirm and support our findings.

Transarterial pacemaker lead implantation results in acute myocardial infarction.

PubMed

Issa, Ziad F; Gill, John B

2010-11-01

We report a case of inadvertent transarterial implantation of dual-chamber pacemaker leads; the ventricular lead positioned across the aortic valve into the left ventricle and the atrial lead curving in the aortic root with the tip positioned into the left circumflex artery, resulting in acute myocardial infarction. The diagnosis was made based on the finding on the chest X-ray, surface ECG, and coronary angiography.

The Brady Bunch? New evidence for nominative determinism in patients' health: retrospective, population based cohort study.

PubMed

Keaney, John J; Groarke, John D; Galvin, Zita; McGorrian, Catherine; McCann, Hugh A; Sugrue, Declan; Keelan, Edward; Galvin, Joseph; Blake, Gavin; Mahon, Niall G; O'Neill, James

2013-12-12

To ascertain whether a name can influence a person's health, by assessing whether people with the surname "Brady" have an increased prevalence of bradycardia. Retrospective, population based cohort study. One university teaching hospital in Dublin, Ireland. People with the surname "Brady" in Dublin, determined through use of an online telephone directory. Prevalence of participants who had pacemakers inserted for bradycardia between 1 January 2007 and 28 February 2013. 579 (0.36%) of 161,967 people who were listed on the Dublin telephone listings had the surname "Brady." The proportion of pacemaker recipients was significantly higher among Bradys (n=8, 1.38%) than among non-Bradys (n=991, 0.61%; P=0.03). The unadjusted odds ratio (95% confidence interval) for pacemaker implantation among individuals with the surname Brady compared with individuals with other surnames was 2.27 (1.13 to 4.57). Patients named Brady are at increased risk of needing pacemaker implantation compared with the general population. This finding shows a potential role for nominative determinism in health.

Pacemakers and implantable cardioverter-defibrillators in pediatric patients.

PubMed

Silka, Michael J; Bar-Cohen, Yaniv

2006-11-01

The use of pacemakers and implantable cardioverter-defibrillators (ICDs) in infants, children, and patients with congenital heart disease presents unique challenges and considerations. They include uncommon indications for device implantation, innovative approaches to lead implantation and configuration, and age-dependent and disease-specific aspects of device programming. In this review, the current indications for pacemaker and ICD implantation in young patients are discussed, followed by consideration of the approaches to lead and device placement in very small patients and those with complex congenital heart disease, in whom unique problems may be encountered. The limitations of programmability of current pacemakers and ICDs when used in young patients are discussed, followed by an analysis of long-term device follow-up and potential late complications.

Cardiac pacemaker dysfunction in children after thoracic drainage catheter manipulation.

PubMed

Lobdell, K W; Walters, H L; Hudson, C; Hakimi, M

1997-05-01

Two children underwent placement of permanent, epicardial-lead, dual-chamber, unipolar pacemaker systems for complete heart block. Postoperatively, both patients demonstrated subcutaneous emphysema-in the area of their pulse generators-temporally related to thoracic catheter manipulation. Acutely, each situation was managed with manual compression of the pulse generator, ascertaining appropriate pacemaker sensing and pacing. Maintenance of compression with pressure dressings, vigilant observation/monitoring, and education of the care givers resulted in satisfactory pacemaker function without invasive intervention.

[TRENDS OF PERMANENT PACEMAKER IMPLANTATION IN A SINGLE CENTER OVER A 20-YEAR PERIOD].

PubMed

Antonelli, Dante; Ilan, Limor Bushar; Freedberg, Nahum A; Feldman, Alexander; Turgeman, Yoav

2015-05-01

To review the changes in permanent pacemaker implantation indications, pacing modes and patients' demographics over a 20-year period. We retrospectively retrieved data on patients who underwent first implantation of the pacemaker between 1-1-1991 and 31-12-2010. One thousand and nine (1,009) patients underwent a first pacemaker implantation during that period; 535 were men (53%), their mean age was 74.6±19.5 years; the highest rate of implanted pacemaker was in patients ranging in age from 70-79 years, however there was an increasing number of patients aged over 80 years. The median survival time after initial pacemaker implantation was 8 years. Syncope was the most common symptom (62.5%) and atrioventricular block was the most common electrocardiographic indication (56.4%) leading to pacemaker implantation. There was increased utilization of dual chamber and rate responsive pacemakers over the years. There was no difference regarding mode selection between genders. Pacemaker implantation rates have increased over a 20-year period. Dual chamber replaced most of the single ventricular chamber pacemaker and rate responsive pacemakers became the norm. The data of a small volume center are similar to those reported in pacemaker surveys of high volume pacemaker implantation centers. They confirm adherence to the published guidelines for pacing.

Transient bradycardia induced by thiopentone sodium: a unique challenge in the management of refractory status epilepticus

PubMed Central

Sharma, Sushma; Nair, Pradeep P; Murgai, Aditya; Selvaraj, Raja J

2013-01-01

Thiopentone sodium is one of the important drugs in the armamentarium for terminating refractory status epilepticus, a neurological emergency. We report a case of thiopentone-related bradycardia during the management of the new onset refractory status epilepticus in a young man, which was circumvented by prophylactic insertion of temporary pacemaker while thiopentone infusion was continued. A systematic approach was employed to manage the status epilepticus, including infusion of thiamine and glucose followed by antiepileptic drugs. The patient was ventilated and infused with lorazepam, phenytoin, sodium valproate, levetiracetam and midazolam followed by thiopentone sodium. With the introduction of thiopentone the seizures could be controlled but the patient developed severe bradycardia and junctional rhythm. The bradycardia disappeared when thiopentone was withdrawn and reappeared when the drug was reintroduced. Propofol infusion was tried with no respite in seizures. Later thiopentone sodium was reintroduced after inserting temporary cardiac pacemaker. Seizure was controlled and patient was weaned off the ventilator. PMID:24130206

Transient bradycardia induced by thiopentone sodium: a unique challenge in the management of refractory status epilepticus.

PubMed

Sharma, Sushma; Nair, Pradeep P; Murgai, Aditya; Selvaraj, Raja J

2013-10-15

Thiopentone sodium is one of the important drugs in the armamentarium for terminating refractory status epilepticus, a neurological emergency. We report a case of thiopentone-related bradycardia during the management of the new onset refractory status epilepticus in a young man, which was circumvented by prophylactic insertion of temporary pacemaker while thiopentone infusion was continued. A systematic approach was employed to manage the status epilepticus, including infusion of thiamine and glucose followed by antiepileptic drugs. The patient was ventilated and infused with lorazepam, phenytoin, sodium valproate, levetiracetam and midazolam followed by thiopentone sodium. With the introduction of thiopentone the seizures could be controlled but the patient developed severe bradycardia and junctional rhythm. The bradycardia disappeared when thiopentone was withdrawn and reappeared when the drug was reintroduced. Propofol infusion was tried with no respite in seizures. Later thiopentone sodium was reintroduced after inserting temporary cardiac pacemaker. Seizure was controlled and patient was weaned off the ventilator.

Novel approach to epicardial pacemaker implantation in patients with limited venous access.

PubMed

Costa, Roberto; Scanavacca, Mauricio; da Silva, Kátia Regina; Martinelli Filho, Martino; Carrillo, Roger

2013-11-01

Limited venous access in certain patients increases the procedural risk and complexity of conventional transvenous pacemaker implantation. The purpose of this study was to determine a minimally invasive epicardial approach using pericardial reflections for dual-chamber pacemaker implantation in patients with limited venous access. Between June 2006 and November 2011, 15 patients underwent epicardial pacemaker implantation. Procedures were performed through a minimally invasive subxiphoid approach and pericardial window with subsequent fluoroscopy-assisted lead placement. Mean patient age was 46.4 ± 15.3 years (9 male [(60.0%], 6 female [40.0%]). The new surgical approach was used in patients determined to have limited venous access due to multiple abandoned leads in 5 (33.3%), venous occlusion in 3 (20.0%), intravascular retention of lead fragments from prior extraction in 3 (20.0%), tricuspid valve vegetation currently under treatment in 2 (13.3%), and unrepaired intracardiac defects in 2 (13.3%). All procedures were successful with no perioperative complications or early deaths. Mean operating time for isolated pacemaker implantation was 231.7 ± 33.5 minutes. Lead placement on the superior aspect of right atrium, through the transverse sinus, was possible in 12 patients. In the remaining 3 patients, the atrial lead was implanted on the left atrium through the oblique sinus, the postcaval recess, or the left pulmonary vein recess. None of the patients displayed pacing or sensing dysfunction, and all parameters remained stable throughout the follow-up period of 36.8 ± 25.1 months. Epicardial pacemaker implantation through pericardial reflections is an effective alternative therapy for those patients requiring physiologic pacing in whom venous access is limited. © 2013 Heart Rhythm Society. All rights reserved.

In-vitro mapping of E-fields induced near pacemaker leads by simulated MR gradient fields

PubMed Central

2009-01-01

Background Magnetic resonance imaging (MRI) of patients with implanted cardiac pacemakers is generally contraindicated but some clinicians condone scanning certain patients. We assessed the risk of inducing unintended cardiac stimulation by measuring electric fields (E) induced near lead tips by a simulated MRI gradient system. The objectives of this study are to map magnetically induced E near distal tips of leads in a saline tank to determine the spatial distribution and magnitude of E and compare them with E induced by a pacemaker pulse generator (PG). Methods We mapped magnetically induced E with 0.1 mm resolution as close as 1 mm from lead tips. We used probes with two straight electrodes (e.g. wire diameter of 0.2 mm separated by 0.9 mm). We generated magnetic flux density (B) with a Helmholtz coil throughout 0.6% saline in a 24 cm diameter tank with (dB/dt) of 1 T/sec (1 kHz sinusoidal waveform). Separately, we measured E near the tip of leads when connected to a PG set to a unipolar mode. Measurements were non-invasive (not altering the leads or PG under study). Results When scaled to 30 T/s (a clinically relevant value), magnetically-induced E exceeded the E produced by a PG. The magnetically-induced E only occurred when B was coincident with or within 15 msec of implantable pacemaker's pulse. Conclusions Potentially hazardous situations are possible during an MR scan due to gradient fields. Unintended stimulation can be induced via abandoned leads and leads connected to a pulse generator with loss of hermetic seal at the connector. Also, pacemaker-dependent patients can receive drastically altered pacing pulses. PMID:20003479

Permanent Leadless Cardiac Pacemaker Therapy: A Comprehensive Review.

PubMed

Tjong, Fleur V Y; Reddy, Vivek Y

2017-04-11

A new technology, leadless pacemaker therapy, was recently introduced clinically to address lead- and pocket-related complications in conventional transvenous pacemaker therapy. These leadless devices are self-contained right ventricular single-chamber pacemakers implanted by using a femoral percutaneous approach. In this review of available clinical data on leadless pacemakers, early results with leadless devices are compared with historical results with conventional single-chamber pacing. Both presently manufactured leadless pacemakers show similar complications, which are mostly related to the implant procedure: cardiac perforation, device dislocation, and femoral vascular access site complications. In comparison with conventional transvenous single-chamber pacemakers, slightly higher short-term complication rates have been observed: 4.8% for leadless pacemakers versus 4.1% for conventional pacemakers. The complication rate of the leadless pacemakers is influenced by the implanter learning curve for this new procedure. No long-term outcome data are yet available for the leadless pacemakers. Larger leadless pacing trials, with long-term follow-up and direct randomized comparison with conventional pacing systems, will be required to define the proper clinical role of these leadless systems. Although current leadless pacemakers are limited to right ventricular pacing, future advanced, communicating, multicomponent systems are expected to expand the potential benefits of leadless therapy to a larger patient population. © 2017 American Heart Association, Inc.

Rupture of a pacemaker lead during the course of infective endocarditis.

PubMed

Akgüllü, Çağdaş; Eryılmaz, Ufuk; Kurtoğlu, Tünay; Özpelit, Ebru

2013-01-01

A 23-year-old male who had a VDDR pacemaker implanted seven years ago due to sick sinus syndrome and recurrent syncope episodes was admitted with symptoms of dyspnea, fever, and tachycardia, which were present for a few days. He was suspected to be suffering from pneumonia and underwent computed tomography scanning of the thorax, which revealed widespread infiltration in the lung parenchyma and pulmonary emboli. Transthoracic echocardiography revealed an extremely mobile echogenic structure in the right atrium, which was determined to be the free portion of a ruptured pacemaker lead. There was an overlying thrombus and/or vegetation-like organized soft tissue within the right ventricle around the lead component. In this article, the rupture of a permanent pacemaker lead, which complicated the course of infective endocarditis associated with pulmonary embolism and pneumonia is reported. We hypothesize that the underlying mechanism for the rupture is soft tissue entrapment within the right ventricle. Unfortunately, this rare and life-threatening situation led to the death of our patient after the surgical removal of the device and its components.

Predictors of Severe Tricuspid Regurgitation in Patients with Permanent Pacemaker or Automatic Implantable Cardioverter-Defibrillator Leads

PubMed Central

Najib, Mohammad Q.; Vittala, Satya S.; Challa, Suresh; Raizada, Amol; Tondato, Fernando J.; Lee, Howard R.; Chaliki, Hari P.

2013-01-01

Patients with permanent pacemaker or automatic implantable cardioverter-defibrillator (AICD) leads have an increased prevalence of tricuspid regurgitation. However, the roles of cardiac rhythm and lead-placement duration in the development of severe tricuspid regurgitation are unclear. We reviewed echocardiographic data on 26 consecutive patients who had severe tricuspid regurgitation after permanent pacemaker or AICD placement; before treatment, they had no organic tricuspid valve disease, pulmonary hypertension, left ventricular dysfunction, or severe tricuspid regurgitation. We compared the results to those of 26 control subjects who had these same devices but no more than mild tricuspid regurgitation. The patients and control subjects were similar in age (mean, 81 ±6 vs 81 ±8 yr; P = 0.83), sex (male, 42% vs 46%; P = 0.78), and left ventricular ejection fraction (0.60 ±0.06 vs 0.58 ± 0.05; P = 0.4). The patients had a higher prevalence of atrial fibrillation (92% vs 65%; P=0.01) and longer median duration of pacemaker or AICD lead placement (49.5 vs 5 mo; P < 0.001). After adjusting for age, sex, and right ventricular systolic pressure by multivariate logistic regression analysis, we found that atrial fibrillation (odds ratio=6.4; P = 0.03) and duration of lead placement (odds ratio=1.5/yr; P = 0.001) were independently associated with severe tricuspid regurgitation. Out study shows that atrial fibrillation and longer durations of lead placement might increase the risk of severe tricuspid regurgitation in patients with permanent pacemakers or AICDs. PMID:24391312

Leadless cardiac pacemakers: present and the future.

PubMed

Chew, Derek S; Kuriachan, Vikas

2018-01-01

Pacing technology for many decades has been composed of a generator attached to leads that are usually transvenous. Recently, leadless pacemakers have been studied in clinical settings and now available for use in many countries. This includes the single-component Nanostim Leadless Cardiac Pacemaker and Micra Transcatheter Pacing System, as well as the multicomponent Wireless Stimulation Endocardial system. Clinical studies in single-component leadless pacing technology has shown that they can be successfully implanted with minimal complications. The follow-up studies also seem to confirm the findings from the initial clinical trials. These systems offer some advantages over a traditional pacing system comprised of a subcutaneous generator and transvenous leads. In many ways, these leadless systems are disruptive technologies that are changing the traditional pacemaker concept and preferred for some patients. Ongoing research is needed to better assess their long-term function, safety, and end-of-life strategies. In the future, multichamber leadless pacing is expected to be developed and perhaps obviating the need for transvenous leads and their associated complications.

75 FR 52629 - Medicare Program; Establishing Additional Medicare Durable Medical Equipment, Prosthetics...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-27

... wheelchairs. Prosthetic devices are included in the definition of ``medical and other health services'' under section 1861(s)(8) of the Act. Prosthetic devices are defined in this section of the Act as ``devices... insertion of an intraocular lens.'' Other examples of prosthetic devices include cardiac pacemakers...

Effects of 60-Heartz electric and magnetic fields on implanted cardiac pacemakers. Final report. [Hazards of power transmission line frequencies

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bridges, J.E.; Frazier, M.J.

1979-09-01

The effects of 60-Hz electric and magnetic fields of exta-high voltage (EHV) transmission lines on the performance of implanted cardiac pacemakers were studied by: (1) in vitro bench tests of a total of thirteen cardiac pacemakers; (2) in vivo tests of six implanted cardiac pacemakers in baboons; and (3) non-hazardous skin measurement tests on four humans. Analytical methods were developed to predict the thresholds of body current and electric fields capable of affecting normal pacemaker operation in humans. The field strengths calculated to alter implanted pacemaker performance were compared with the range of maximum electric and magnetic field strengths amore » human would normally encounter under transmission lines of various voltages. Results indicate that the electric field or body current necessary to alter the normal operation of pacemakers is highly dependent on the type of pacemaker and the location of the implanted electrodes. However, cardiologists have not so far detected harmful effects of pacemaker reversion to the asynchronous mode in current types of pacemakers and with present methods of implantation. Such interferences can be eliminated by using advanced pacemakers less sensitive to 60-Hz voltages or by using implantation lead arrangements less sensitive to body current.« less

The Brady Bunch? New evidence for nominative determinism in patients’ health: retrospective, population based cohort study

PubMed Central

Groarke, John D; Galvin, Zita; McGorrian, Catherine; McCann, Hugh A; Sugrue, Declan; Keelan, Edward; Galvin, Joseph; Blake, Gavin; Mahon, Niall G; O’Neill, James

2013-01-01

Objective To ascertain whether a name can influence a person’s health, by assessing whether people with the surname “Brady” have an increased prevalence of bradycardia. Design Retrospective, population based cohort study. Setting One university teaching hospital in Dublin, Ireland. Participants People with the surname “Brady” in Dublin, determined through use of an online telephone directory. Main outcome measure Prevalence of participants who had pacemakers inserted for bradycardia between 1 January 2007 and 28 February 2013. Results 579 (0.36%) of 161 967 people who were listed on the Dublin telephone listings had the surname “Brady.” The proportion of pacemaker recipients was significantly higher among Bradys (n=8, 1.38%) than among non-Bradys (n=991, 0.61%; P=0.03). The unadjusted odds ratio (95% confidence interval) for pacemaker implantation among individuals with the surname Brady compared with individuals with other surnames was 2.27 (1.13 to 4.57). Conclusions Patients named Brady are at increased risk of needing pacemaker implantation compared with the general population. This finding shows a potential role for nominative determinism in health. PMID:24336304

Permanent pacemaker insertion following isolated aortic valve replacement before and after the introduction of TAVI.

PubMed

Kogan, Alexander; Sternik, Leonid; Beinart, Roy; Shalabi, Amjad; Glikson, Michael; Spiegelstein, Danny; Levin, Shany; Raanani, Ehud

2015-04-01

Permanent pacemaker (PPM) implantation is required in 3-12% of all patients undergoing surgical aortic valve replacement (AVR). Our aim was to evaluate the contemporary incidence and impact of the introduction of transcatheter aortic valve implantation (TAVI) for PPM insertion after isolated AVR. Since 2004, during a 10-year period, a total of 858 patients underwent isolated AVR at our institution. Forty-one patients with PPM before operation were excluded from the study and 817 patients were included in the statistical analysis. Of these, 20 patients (2.45%) developed significant conduction disorders, leading to PPM implantation within 120 days postoperatively. Patients were further divided into two groups. Before (Group I: June 2004 to September 2008) and after (Group II: October 2008 to May 2014) the introduction of the TAVI program. There were 343 patients in Group I and 475 patients in Group II. The incidence of PPM implantation decreased from 3.79% (13 patients) in Group I to 1.47% (seven patients) in Group II (P < 0.001). Risk factors for permanent pacing identified by univariate analysis were: Group I (before introducing TAVI program), pulmonary hypertension, preoperative anemia, age older than 75 years, and previous myocardial infarction. Multivariate analysis identified Group I (before introducing TAVI program; P < 0.005; odds ratio [OR] 15.2, 95% confidence interval [CI] 6.3-19.9) and pulmonary hypertension (P < 0.005; OR 12.5, 95% CI 3.2-18.3) to be significant. Irreversible atrio-ventricular block or symptomatic bradycardia requiring PPM implantation is a relatively rare complication. The incidence of PPM implantation after isolated surgical AVR decreased in a contemporary setting after the introduction of the TAVI program. ©2015 Wiley Periodicals, Inc.

Incidence of ventricular tachyarrhythmias during permanent pacemaker therapy in low-risk patients results from the German multicentre EVENTS study.

PubMed

Faber, Thomas S; Gradinger, Robert; Treusch, Sven; Morkel, Carsten; Brachmann, Johannes; Bode, Christoph; Zehender, Manfred

2007-09-01

Current studies found an incidence of 12-31% ventricular tachyarrhythmias and sudden cardiac death during cardiac pacing months or even years after pacemaker insertion. MADIT(12) and MUSTT(13) demonstrated that patients with poor LV function after Myocardial infarction (MI) showing non-sustained ventricular tachycardia (nsVT) and inducibility during electrophysiologic testing benefit from an ICD. The present study was dedicated to assess the global incidence of non-sustained ventricular arrhythmias in a general population of pacemaker patients. Special regard was on patients with a potential ICD indication, e.g. those matching the MADIT/MUSTT criteria. Two hundred and thirty-one patients (72 +/- 11 years; 134 men) with an indication for dual chamber pacing entered the study. In all patients pacemaker systems capable of automatic storing of intracardiac electrocardiograms were implanted (Pulsar, Discovery, Guidant). Follow-up time was 15 months after inclusion. In 54 (25.7%) of 210 patients with at least one follow-up, episodes of nsVT were documented by stored electrocardiograms (up to >30 beats, >200 b.p.m.). Multiple-up to nine-episodes of ventricular tachycardia were retrieved in 31 of these patients. Three out of 14 patients with an LVEF <40% after MI presented nsVT during the follow-up. One of these patients received an ICD. A significant number of pacemaker patients present with ventricular tachycardia. Intracardiac electrocardiograms and alert functions from pacemakers may enhance physicians' awareness of the patient's intrinsic arrhythmic profile and help uncover underlying mechanisms of arrhythmias by storing the initiation of the arrhythmia.

Minimally Invasive Epicardial Pacemaker Implantation in Neonates with Congenital Heart Block.

PubMed

Costa, Roberto; Silva, Katia Regina da; Martinelli Filho, Martino; Carrillo, Roger

2017-10-01

Few studies have characterized the surgical outcomes following epicardial pacemaker implantation in neonates with congenital complete atrioventricular block (CCAVB). This study sought to assess the long-term outcomes of a minimally invasive epicardial approach using a subxiphoid access for pacemaker implantation in neonates. Between July 2002 and February 2015, 16 consecutive neonates underwent epicardial pacemaker implantation due to CCAVB. Among these, 12 (75.0%) had congenital heart defects associated with CCAVB. The patients had a mean age of 4.7 ± 5.3 days and nine (56.3%) were female. Bipolar steroid-eluting epicardial leads were implanted in all patients through a minimally invasive subxiphoid approach and fixed on the diaphragmatic ventricular surface. The pulse generator was placed in an epigastric submuscular position. All procedures were successful, with no perioperative complications or early deaths. Mean operating time was 90.2 ± 16.8 minutes. None of the patients displayed pacing or sensing dysfunction, and all parameters remained stable throughout the follow-up period of 4.1 ± 3.9 years. Three children underwent pulse generator replacement due to normal battery depletion at 4.0, 7.2, and 9.0 years of age without the need of ventricular lead replacement. There were two deaths at 12 and 325 days after pacemaker implantation due to bleeding from thrombolytic use and progressive refractory heart failure, respectively. Epicardial pacemaker implantation through a subxiphoid approach in neonates with CCAVB is technically feasible and associated with excellent surgical outcomes and pacing lead longevity.

Characterization of a right atrial subsidiary pacemaker and acceleration of the pacing rate by HCN over-expression.

PubMed

Morris, Gwilym M; D'Souza, Alicia; Dobrzynski, Halina; Lei, Ming; Choudhury, Moinuddin; Billeter, Rudi; Kryukova, Yelena; Robinson, Richard B; Kingston, Paul A; Boyett, Mark R

2013-10-01

Although the right atrium (RA contains subsidiary atrial pacemaker (SAP) tissue that can take over from the sinoatrial node (SAN) in sick sinus syndrome (SSS), SAP tissue is bradycardic. Little is known about SAP tissue and one aim of the study was to characterize ion channel expression to obtain insight into SAP pacemaker mechanisms. A second aim was to determine whether HCN over-expression (a 'biopacemaker'-like strategy) can accelerate the pacemaker rate producing a pacemaker that is similar in nature to the SAN. SAP tissue was isolated from the rat and the leading pacemaker site was characterized. Cell size at the leading pacemaker site in the SAP was smaller than in the RA and comparable to that in the SAN. mRNA levels showed the SAP to be similar to, but distinct from, the SAN. For example, in the SAN and SAP, expression of Tbx3 and HCN1 was higher and Nav1.5 and Cx43 lower than in the RA. Organ-cultured SAP tissue beat spontaneously, but at a slower rate than the SAN. Adenovirus-mediated gene transfer of HCN2 and the chimeric protein HCN212 significantly increased the pacemaker rate of the SAP close to that of the native SAN, but HCN4 was ineffective. SAP tissue near the inferior vena cava is bradycardic, but shares characteristics with the SAN. Pacing can be accelerated by the over-expression of HCN2 or HCN212. This provides proof of concept for the use of SAP tissue as a substrate for biopacemaking in the treatment of SSS.

42 CFR 410.10 - Medical and other health services: Included services.

Code of Federal Regulations, 2013 CFR

2013-10-01

... vaccinations. (m) Outpatient physical therapy and speech pathology services. (n) Cardiac pacemakers and pacemaker leads. (o) Additional services furnished to enrollees of HMOs or CMPs, as described in § 410.58...

42 CFR 410.10 - Medical and other health services: Included services.

Code of Federal Regulations, 2014 CFR

2014-10-01

... vaccinations. (m) Outpatient physical therapy and speech pathology services. (n) Cardiac pacemakers and pacemaker leads. (o) Additional services furnished to enrollees of HMOs or CMPs, as described in § 410.58...

42 CFR 410.10 - Medical and other health services: Included services.

Code of Federal Regulations, 2012 CFR

2012-10-01

... vaccinations. (m) Outpatient physical therapy and speech pathology services. (n) Cardiac pacemakers and pacemaker leads. (o) Additional services furnished to enrollees of HMOs or CMPs, as described in § 410.58...

The effect of right ventricle pacemaker lead position on diastolic function in patients with preserved left ventricle ejection fraction.

PubMed

Mitov, Vladimir; Perisić, Zoran; Jolić, Aleksandar; Adamović, Dragana; Zastranović, Lale; Aleksić, Aleksandar; Kostić, Tomislav; Božinović, Nenad; Aleksić, Zeljka; Soldatović, Ivan

2013-01-01

Our aim was to analyze any changes during diastole in patients with normal left ventricular ejection fraction (LVEF), after pacemaker stimulation from the right ventricular outflow tract (RVOT) and right ventricular apex (RVA) lead position. This was a prospective, randomized, follow up study, which lasted for 12 months. Our research included 132 consecutive patients who were implanted with a permanent antibradycardiac pacemaker. Regarding the right ventricle lead position the patients were divided into two groups: The RVOT group--71 patients, with right ventricle outflow tract lead position and the RVA group--61 patients, with right ventricle apex lead position. We measured LVEF and diastolic parameters: peak filling ratio and time to peak filling ratio obtained by radionuclide ventriculography (RNV). The LVEF and various diastolic parameters and left atrial diameter were obtained by echocardiography. Based on the values of deceleration time of early diastolic filling (DTE), and other diastolic parameters like left atrial diameter, all the patients were classified into three degrees of diastolic dysfunction. Our results showed that there was no group difference in distribution of gender, age, body mass index (BMI), VVI to DDD pacemakers implantation ratio, RNV parameters (LVEF, peak filling rate (PFR), time to PFR (TPFR)) and echocardiography parameters: LVEF and parameters of diastolic dysfunction. After 12 months of pacemaker stimulation, LVEF by RNV remained the same in the RVOT group 51.31±15.80% (P=0.75), and also in the RVA group 53.83±6.57%, (P=0.19). In the RVOT group the PFR was highly lower and this finding was significant (P=0.01), while TPFR was also significantly lower (P=0.03). By dividing the patients according to the degree of diastolic dysfunction we found that most patients in both groups at enrollment had a second degree diastolic dysfunction. In both groups diastolic dysfunction increased, the number of patients with third degree diastolic dysfunction increased, and the number of patients with second degree diastolic dysfunction decreased, however, the worsening of diastolic function was significant only in the RVOT group. In conclusion, pacemaker stimulation from RVOT, but not in RVA, leads to progression of diastolic dysfunction in patients with preserved LVEF. This negative effect of pacemaker stimulation from RVOT on diastolic parameters was confirmed by two independent methods, RNV and echocardiography.

Proton Beam Therapy Interference With Implanted Cardiac Pacemakers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Oshiro, Yoshiko; Sugahara, Shinji; Noma, Mio

2008-11-01

Purpose: To investigate the effect of proton beam therapy (PBT) on implanted cardiac pacemaker function. Methods and Materials: After a phantom study confirmed the safety of PBT in patients with cardiac pacemakers, we treated 8 patients with implanted pacemakers using PBT to a total tumor dose of 33-77 gray equivalents (GyE) in dose fractions of 2.2-6.6 GyE. The combined total number of PBT sessions was 127. Although all pulse generators remained outside the treatment field, 4 patients had pacing leads in the radiation field. All patients were monitored by means of electrocardiogram during treatment, and pacemakers were routinely examined beforemore » and after PBT. Results: The phantom study showed no effect of neutron scatter on pacemaker generators. In the study, changes in heart rate occurred three times (2.4%) in 2 patients. However, these patients remained completely asymptomatic throughout the PBT course. Conclusions: PBT can result in pacemaker malfunctions that manifest as changes in pulse rate and pulse patterns. Therefore, patients with cardiac pacemakers should be monitored by means of electrocardiogram during PBT.« less

Influence of Slippery Pacemaker Leads on Lead-Induced Venous Occlusion

NASA Astrophysics Data System (ADS)

Yang, Weiguang; Bhatia, Sagar; Obenauf, Dayna; Resse, Max; Esmaily-Moghadam, Mahdi; Feinstein, Jeffrey; Pak, On Shun

2016-11-01

The use of medical devices such as pacemakers and implantable cardiac defibrillators have become commonplace to treat arrhythmias. Pacing leads with electrodes are used to send electrical pulses to the heart to treat either abnormally slow heart rates, or abnormal rhythms. Lead induced vessel occlusion, which is commonly seen after placement of pacemaker or ICD leads, may result in lead malfunction and/or SVC syndrome, and makes lead extraction difficult. The association between the anatomic locations at risk for thrombosis and regions of venous stasis have been reported previously. The computational studies reveal obvious flow stasis in the proximity of the leads, due to the no-slip boundary condition imposed on the lead surface. With the advent of recent technologies capable of creating slippery surfaces that can repel complex fluids including blood, we explore computationally how local flow structures may be altered in the regions around the leads when the no-slip boundary condition on the lead surface is relaxed using various slip lengths. The findings evaluate the possibility of mitigating risks of lead-induced thrombosis and occlusion by implementing novel surface conditions (i.e. theoretical coatings) on the leads.

Calcium Homeostatasis and Mitochondrial Dysfunction in Dopaminergic Neurons of the Substantia Nigra

DTIC Science & Technology

2010-03-01

discovery that calcium entry through L-type channels during normal pacemaking elevates the sensitivity of SNc dopaminergic neurons to toxins; • the...discovery that L-type calcium channels participate in but are not necessary for pacemaking; • the discovery that serum concentration of the...FDA approved doses; • the discovery that calcium entry through L-type channels during pacemaking elevates mitochondrial oxidant stress and leads

Pacemaker recycling: A notion whose time has come.

PubMed

Runge, Mason W; Baman, Timir S; Davis, Sheldon; Weatherwax, Kevin; Goldman, Ed; Eagle, Kim A; Crawford, Thomas C

2017-04-26

The purpose of this paper is to summarize the need, feasibility, safety, legality, and ethical perspectives of pacemaker reutilization in low- and middle-income countries (LMICs). It will also describe, in-depth, Project My Heart Your Heart (PMHYH) as a model for pacemaker reuse in LMICs. The primary source of the discussion points in this paper is a collection of 14 publications produced by the research team at the University of Michigan and its collaborative partners. The need for pacemaker reutilization in LMICs is evident. Numerous studies show that the concept of pacemaker reutilization in LMICs is feasible. Infection and device malfunction are the main concerns in regard to pacemaker reutilization, yet many studies have shown that pacemaker reuse is not associated with increased infection risk or higher mortality compared with new device implantation. Under the right circumstances, the ethical and legal bases for pacemaker reutilization are supported. PMHYH is a proof of concept pacemaker donation initiative that has allowed funeral home and crematory directors to send explanted devices to an academic center for evaluation and re-sterilization before donation to underserved patients in LMICs. The time is now to pursue large-scale studies and trials of pacemaker reuse for the betterment of society. PMHYH is leading the way in the effort and is poised to conduct a prospective randomized, non-inferiority, multicenter study to confirm the clinical efficacy and safety of pacemaker reuse, for clinical and legal support.

Pacemaker-induced Metallic Artifacts in Coronary Computed Tomography Angiography: Clinical Feasibility of Single Energy Metal Artifact Reduction Technique.

PubMed

Takayanagi, Tomoya; Arai, Takehiro; Amanuma, Makoto; Sano, Tomonari; Ichiba, Masato; Ishizaka, Kazumasa; Sekine, Takako; Matsutani, Hideyuki; Morita, Hitomi; Takase, Shinichi

2017-01-01

Coronary computed tomography angiography (CCTA) in patients with pacemaker suffers from metallic lead-induced artifacts, which often interfere with accurate assessment of coronary luminal stenosis. The purpose of this study was to assess a frequency of the lead-induced artifacts and artifact-suppression effect by the single energy metal artifact reduction (SEMAR) technique. Forty-one patients with a dual-chamber pacemaker were evaluated using a 320 multi-detector row CT (MDCT). Among them, 22 patients with motion-free full data reconstruction images were the final candidates. Images with and without the SMEAR technique were subjectively compared, and the degree of metallic artifacts was compared. On images without SEMAR, severe metallic artifacts were often observed in the right coronary artery (#1, #2, #3) and distal anterior descending branch (#8). These artifacts were effectively suppressed by SEMAR, and the luminal accessibility was significantly improved in #3 and #8. While pacemaker leads often cause metallic-induced artifacts, SEMAR technique reduced the artifacts and significantly improved the accessibility of coronary lumen in #3 and #8.

Case of pacemaker pocket infection caused by Finegoldia magna.

PubMed

Hosseini Dehkordi, Seyed Hamed; Osorio, Georgina

2017-10-01

Finegoldia magna (formerly called Peptostreptococcus magnus) is a Gram-positive anaerobic coccus which is increasingly recognized as an opportunistic pathogen. We present a case of F. magna associated non-valvular cardiovascular device-related infection in an 83 year-old male who received a permanent pacemaker for sick sinus syndrome seven weeks prior to his presentation. Five weeks after the implantation, the pacemaker and leads were explanted because of clinical evidence of pacemaker pocket infection. He was initially treated with sulfamethoxazole-trimethoprim based on the Gram stain results from the removed pacemaker. However, two weeks later, he was readmitted with sepsis and was successfully treated with ampicillin-sulbactam. Culture results from the pacemaker and pocket as well as blood cultures grew F. magna. Clinicians should be aware of the possibility of F. magna infection when initial gram stain results show "gram positive cocci". Copyright © 2017 Elsevier Ltd. All rights reserved.

Analysis of a five year experience of permanent pacemaker implantation at a Nigerian Teaching Hospital: need for a national database

PubMed Central

Falase, Bode; Sanusi, Michael; Johnson, Adeyemi; Akinrinlola, Fola; Ajayi, Reina; Oke, David

2013-01-01

Introduction Permanent pacemaker implantation is available in Nigeria. There is however no national registry or framework for pacemaker data collection. A pacemaker database has been developed in our institution and the results are analyzed in this study. Methods The study period was between January 2008 and December 2012. Patient data was extracted from a prospectively maintained database which was designed to include the fields of the European pacemaker patient identification code. Results Of the 51 pacemaker implants done, there were 29 males (56.9%) and 22 females (43.1%). Mean age was 68.2±12.7 years. Clinical indications were syncopal attacks in 25 patients (49%), dizzy spells in 15 patients (29.4%), bradycardia with no symptoms in 10 patients (17.7%) and dyspnoea in 2 patients (3.9%). The ECG diagnosis was complete heart block in 27 patients (53%), second degree heart block in 19 patients (37.2%) and sick sinus syndrome with bradycardia in 5 patients (9.8%). Pacemaker modes used were ventricular pacing in 29 patients (56.9%) and dual chamber pacing in 22 patients (43.1%). Files have been closed in 20 patients (39.2%) and 31 patients (60.8%) are still being followed up with median follow up of 26 months, median of 5 visits and 282 pacemaker checks done. Complications seen during follow up were 3 lead displacements (5.9%), 3 pacemaker infections (5.9%), 2 pacemaker pocket erosions (3.9%), and 1 pacemaker related death (2%). There were 5 non-pacemaker related deaths (9.8%). Conclusion Pacemaker data has been maintained for 5 years. We urge other implanting institutions in Nigeria to maintain similar databases and work towards establishment of a national pacemaker registry. PMID:24498465

Partial rupture of the tricuspid valve after extraction of permanent pacemaker leads: detection by transesophageal echocardiography.

PubMed

Assayag, P; Thuaire, C; Benamer, H; Sebbah, J; Leport, C; Brochet, E

1999-06-01

Traumatic lesions of the tricuspid valve complicating pacemaker lead extractions appear to be rare. We report two cases of partial rupture of the tricuspid valve, following apparently uneventful extraction of permanent ventricular leads, resulting in severe regurgitation and, in one case, chronic heart failure. TEE was useful to identify the traumatic mechanism of tricuspid regurgitation (TR) and the extent of valvular lesions in these patients. Such etiology should be suspected, and TEE performed, in patients developing TR or heart failure late after lead extraction.

Corrosion and degradation of a polyurethane/Co-Ni-Cr-Mo pacemaker lead

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sung, P.; Fraker, A.C.

1987-12-01

An investigation to study changes in the metal surfaces and the polyurethane insulation of heart pacemaker leads under controlled in vitro conditions was conducted. A polyurethane (Pellethane 2363-80A)/Co-Ni-Cr-Mo (MP35N) wire lead was exposed in Hanks' physiological saline solution for 14 months and then analyzed using scanning electron microscopy, x-ray energy dispersive analysis, and small angle x-ray scattering. Results showed that some leakage of solution into the lead had occurred and changes were present on both the metal and the polyurethane surfaces.

Case study thoracic radiotherapy in an elderly patient with pacemaker: The issue of pacing leads

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kirova, Youlia M., E-mail: youlia.kirova@curie.net; Menard, Jean; Chargari, Cyrus

2012-07-01

To assess clinical outcome of patients with pacemaker treated with thoracic radiation therapy for T8-T9 paravertebral chloroma. A 92-year-old male patient with chloroma presenting as paravertebral painful and compressive (T8-T9) mass was referred for radiotherapy in the Department of Radiation Oncology, Institut Curie. The patient presented with cardiac dysfunction and a permanent pacemaker that had been implanted prior. The decision of Multidisciplinary Meeting was to deliver 30 Gy in 10 fractions for reducing the symptoms and controlling the tumor growth. The patient received a total dose of 30 Gy in 10 fractions using 4-field conformal radiotherapy with 20-MV photons. Themore » dose to pacemaker was 0.1 Gy but a part of the pacing leads was in the irradiation fields. The patient was treated the first time in the presence of his radiation oncologist and an intensive care unit doctor. Moreover, the function of his pacemaker was monitored during the entire radiotherapy course. No change in pacemaker function was observed during any of the radiotherapy fractions. The radiotherapy was very well tolerated without any side effects. The function of the pacemaker was checked before and after the radiotherapy treatment by the cardiologist and no pacemaker dysfunction was observed. Although updated guidelines are needed with acceptable dose criteria for implantable cardiac devices, it is possible to treat patients with these devices and parts encroaching on the radiation field. This case report shows we were able to safely treat our patient through a multidisciplinary approach, monitoring the patient during each step of the treatment.« less

An RF-induced voltage sensor for investigating pacemaker safety in MRI.

PubMed

Barbier, Thérèse; Piumatti, Roberto; Hecker, Bertrand; Odille, Freddy; Felblinger, Jacques; Pasquier, Cédric

2014-12-01

Magnetic resonance imaging (MRI) is inadvisable for patients with pacemakers, as radiofrequency (RF) voltages induced in the pacemaker leads may cause the device to malfunction. Our goal is to develop a sensor to measure such RF-induced voltages during MRI safety tests. A sensor was designed (16.6 cm(2)) for measuring voltages at the connection between the pacemaker lead and its case. The induced voltage is demodulated, digitized, and transferred by optical fibres. The sensor was calibrated on the bench using RF pulses of known amplitude and duration. Then the sensor was tested during MRI scanning at 1.5 T in a saline gel filled phantom. Bench tests showed measurement errors below 5% with a (-40 V; +40 V) range, a precision of 0.06 V, and a temporal resolution of 24.2 μs. In MRI tests, variability in the measured voltages was below 3.7% for 996 measurements with different sensors and RF exposure. Coupling between the sensor and the MRI electromagnetic environment was estimated with a second sensor connected and was below 6.2%. For a typical clinical MRI sequence, voltages around ten Vp were detected. We have built an accurate and reproducible tool for measuring RF-induced voltages in pacemaker leads during MR safety investigations. The sensor might also be used with other conducting cables including those used for electrocardiography and neurostimulation.

Tricuspid regurgitation in patients with pacemakers and implantable cardiac defibrillators: a comprehensive review.

PubMed

Al-Bawardy, Rasha; Krishnaswamy, Amar; Bhargava, Mandeep; Dunn, Justin; Wazni, Oussama; Tuzcu, E Murat; Stewart, William; Kapadia, Samir R

2013-05-01

Implantable cardiac devices, including defibrillators and pacemakers, may be the cause of tricuspid regurgitation (TR) or may worsen existing TR. This review of the literature suggests that TR usually occurs over time after lead implantation. Diagnosis by clinical exam and 2-dimensional echocardiography may be augmented by 3-dimensional echocardiography and/or computed tomography. The mechanism may be mechanical perforation or laceration of leaflets, scarring and restriction of leaflets, or asynchronized activation of the right ventricle. Pacemaker-related TR might cause severe right-sided heart failure, but data regarding associated mortality are lacking. This comprehensive review summarizes the data regarding incidence, mechanism, and treatment of lead-related TR. © 2013 Wiley Periodicals, Inc.

Pacemaker recycling: A notion whose time has come

PubMed Central

Runge, Mason W; Baman, Timir S; Davis, Sheldon; Weatherwax, Kevin; Goldman, Ed; Eagle, Kim A; Crawford, Thomas C

2017-01-01

The purpose of this paper is to summarize the need, feasibility, safety, legality, and ethical perspectives of pacemaker reutilization in low- and middle-income countries (LMICs). It will also describe, in-depth, Project My Heart Your Heart (PMHYH) as a model for pacemaker reuse in LMICs. The primary source of the discussion points in this paper is a collection of 14 publications produced by the research team at the University of Michigan and its collaborative partners. The need for pacemaker reutilization in LMICs is evident. Numerous studies show that the concept of pacemaker reutilization in LMICs is feasible. Infection and device malfunction are the main concerns in regard to pacemaker reutilization, yet many studies have shown that pacemaker reuse is not associated with increased infection risk or higher mortality compared with new device implantation. Under the right circumstances, the ethical and legal bases for pacemaker reutilization are supported. PMHYH is a proof of concept pacemaker donation initiative that has allowed funeral home and crematory directors to send explanted devices to an academic center for evaluation and re-sterilization before donation to underserved patients in LMICs. The time is now to pursue large-scale studies and trials of pacemaker reuse for the betterment of society. PMHYH is leading the way in the effort and is poised to conduct a prospective randomized, non-inferiority, multicenter study to confirm the clinical efficacy and safety of pacemaker reuse, for clinical and legal support. PMID:28515847

Trends in Cardiac Pacemaker Batteries

PubMed Central

Mallela, Venkateswara Sarma; Ilankumaran, V; Rao, N.Srinivasa

2004-01-01

Batteries used in Implantable cardiac pacemakers-present unique challenges to their developers and manufacturers in terms of high levels of safety and reliability. In addition, the batteries must have longevity to avoid frequent replacements. Technological advances in leads/electrodes have reduced energy requirements by two orders of magnitude. Micro-electronics advances sharply reduce internal current drain concurrently decreasing size and increasing functionality, reliability, and longevity. It is reported that about 600,000 pacemakers are implanted each year worldwide and the total number of people with various types of implanted pacemaker has already crossed 3 million. A cardiac pacemaker uses half of its battery power for cardiac stimulation and the other half for housekeeping tasks such as monitoring and data logging. The first implanted cardiac pacemaker used nickel-cadmium rechargeable battery, later on zinc-mercury battery was developed and used which lasted for over 2 years. Lithium iodine battery invented and used by Wilson Greatbatch and his team in 1972 made the real impact to implantable cardiac pacemakers. This battery lasts for about 10 years and even today is the power source for many manufacturers of cardiac pacemakers. This paper briefly reviews various developments of battery technologies since the inception of cardiac pacemaker and presents the alternative to lithium iodine battery for the near future. PMID:16943934

An approach to ablate and pace:AV junction ablation and pacemaker implantation performed concurrently from the same venous access site.

PubMed

Issa, Ziad F

2007-09-01

Atrioventricular junction (AVJ) ablation combined with permanent pacemaker implantation (the "ablate and pace" approach) remains an acceptable alternative treatment strategy for symptomatic, drug-refractory atrial fibrillation (AF) with rapid ventricular response. This case series describes the feasibility and safety of catheter ablation of the AVJ via a superior vena caval approach performed during concurrent dual-chamber pacemaker implantation. A total of 17 consecutive patients with symptomatic, drug-refractory, paroxysmal AF underwent combined AVJ ablation and dual-chamber pacemaker implantation procedure using a left axillary venous approach. Two separate introducer sheaths were placed into the axillary vein. The first sheath was used for implantation of the pacemaker ventricular lead, which was then connected to the pulse generator. Subsequently, a standard ablation catheter was introduced through the second axillary venous sheath and used for radiofrequency (RF) ablation of the AVJ. After successful ablation, the catheter was withdrawn and the pacemaker atrial lead was advanced through that same sheath and implanted in the right atrium. Catheter ablation of the AVJ was successfully achieved in all patients. The median number of RF applications required to achieve complete AV block was three (range 1-10). In one patient, AV conduction recovered within the first hour after completion of the procedure, and AVJ ablation was then performed using the conventional femoral venous approach. There were no procedural complications. Catheter ablation of the AVJ can be performed successfully and safely via a superior vena caval approach in patients undergoing concurrent dual-chamber pacemaker implantation.

Twenty-Seven Years Experience With Transvenous Pacemaker Implantation in Children Weighing <10 kg.

PubMed

Konta, Laura; Chubb, Mark Henry; Bostock, Julian; Rogers, Jan; Rosenthal, Eric

2016-02-01

Epicardial pacemaker implantation is the favored approach in children weighing <10 kg in many units. The high incidence of premature failure and fractures with earlier epicardial leads led our unit to undertake transvenous pacemaker implantation in neonates and infants from 1987. To date there have been no long-term follow-up reports of what is for many a controversial strategy. Between 1987 and 2003, 37 neonates and infants-median age 6.7 months (1 day to 3 years) and median weight 4.6 kg (2.7-10 kg)-had a permanent transvenous pacing system implanted. Pacing leads were placed into the right ventricular apex/outflow tract through a subclavian vein puncture with a redundant loop in the atrium. Three patients were lost to follow-up, 4 patients died from complications of cardiac surgery, and 2 patients had their system removed. At long-term follow-up in 28 patients at a median of 17.2 (range, 11.2-27.4) years, 10 patients have a single chamber ventricular pacemaker, 14 a dual chamber pacemaker, 3 a biventricular pacemaker, and 1 has a single chamber implantable cardioverter defibrillator. Subclavian vein patency was assessed in 26 patients. The overall subclavian vein occlusion rate was 10 of 13 (77%) <5 kg and 2 of 13 (15%) >5 kg during long-term follow-up. After a median of 14.3 (range, 13.4-17.6) years of pacing, 7 patients continue with their original lead. Transvenous pacing in infants <10 kg results in encouraging short- and long-term clinical outcomes. Subclavian vein occlusion remains an important complication, occurring predominantly in those weighing <5 kg. © 2016 American Heart Association, Inc.

Complete removal of infected devices and simultaneous implantation of new devices for infective endocarditis after pacemaker implantation.

PubMed

Miura, Takuya; Inoue, Kazushige; Yokota, Takenori; Iwata, Takashi; Yoshitatsu, Masao

2017-02-01

Two cases of infective endocarditis after pacemaker implantation were reported. Complete removal of infected devices was performed under cardiopulmonary bypass, and simultaneous implantation of new devices was performed using epicardial leads and generator on the abdominal wall. The postoperative course was uneventful and recurrence was not recognized. These procedures may be suitable for the patients who depend on the pacemaker or who have repeat bacteremia with other infectious disease or conditions.

A Meta-Analysis Examining Differences in Short-Term Outcomes Between Sutureless and Conventional Aortic Valve Prostheses.

PubMed

Hurley, Eoghan T; O'Sullivan, Katie E; Segurado, Ricardo; Hurley, John P

2015-01-01

Sutureless aortic valve prostheses are anchored by radial force in a mechanism similar to that of transcatheter aortic valve implantation. Transcatheter aortic valve implantation is associated with an increased permanent pacemaker (PPM) requirement in a significant proportion of patients. We undertook a meta-analysis to examine the incidence of PPM insertion associated with sutureless compared with conventional surgical aortic valve replacement. A systematic review was conducted in accordance with the Prisma guidelines. All searches were performed on August 10, 2014. Studies between 2007 and 2014 were included in the search. A total of 832 patients were included in the sutureless group and 3,740 in the conventional group. Aortic cross-clamp (39.8 vs 62.4 minutes; P < 0.001) and cardiopulmonary bypass (64.9 vs 86.7 minutes; P = 0.002) times were shorter in the sutureless group. Permanent pacemaker implantation rate was higher in the sutureless cohort (9.1% vs 2.4%; P = 0.025). Sutureless aortic valve prostheses are associated with significantly shorter cardiopulmonary bypass and aortic cross-clamp times and a higher incidence of PPM insertion than conventional. Further investigation of the prognostic significance is required.

Safety of implantable pacemakers and cardioverter defibrillators in the magnetic field of a novel remote magnetic navigation system.

PubMed

Jilek, Clemens; Tzeis, Stylianos; Reents, Tilko; Estner, Heidi-Luise; Fichtner, Stephanie; Ammar, Sonia; Wu, Jinjin; Hessling, Gabriele; Deisenhofer, Isabel; Kolb, Christof

2010-10-01

Electromagnetic interference with pacemaker and implantable cardioverter defibrillator (ICD) systems may cause temporary or permanent system malfunction of implanted devices. The aim of this study was to evaluate potential interference of a novel magnetic navigation system with implantable rhythm devices. A total of 121 devices (77 pacemakers, 44 ICDs) were exposed to an activated NIOBE II® Magnetic Navigation System (Stereotaxis, St. Louis, MO, USA) at the maximal magnetic field strength of 0.1 Tesla and evaluated in vitro with respect to changes in parameter settings of the device, changes of the battery status/detection of elective replacement indication, or alterations of data stored in the device. A total of 115 out of 121 (95%) devices were free of changes in parameter settings, battery status, and internally stored data after repeated exposition to the electromagnetic field of the remote magnetic navigation system. Interference with the magnetic navigation field was observed in 6 pacemakers, resulting in reprogramming to a power-on-reset mode with or without detection of the elective replacement indication in 5 devices and abnormal variance of battery status in one device. All pacemakers could be reprogrammed to the initial modes and the battery status proved to be normal some minutes after the pacemakers had been removed from the magnetic field. Interference of a remote magnetic navigation system (at maximal field strength) with pacemakers and ICDs not connected to leads with antitachycardic detection and therapies turned off is rare. Occurring functional abnormalities could be reprogrammed in our sample. An in vitro study will give information about interference of devices connected to leads. © 2010 Wiley Periodicals, Inc.

Global health resource utilization associated with pacemaker complications.

PubMed

Waweru, Catherine; Steenrod, Anna; Wolff, Claudia; Eggington, Simon; Wright, David Jay; Wyrwich, Kathleen W

2017-07-01

To estimate health resource utilization (HRU) associated with the management of pacemaker complications in various healthcare systems. Electrophysiologists (EPs) from four geographical regions (Western Europe, Australia, Japan, and North America) were invited to participate. Survey questions focused on HRU in the management of three chronic pacemaker complications (i.e. pacemaker infections requiring extraction, lead fractures/insulation breaches requiring replacement, and upper extremity deep venous thrombosis [DVT]). Panelists completed a maximum of two web-based surveys (iterative rounds). Mean, median values, and interquartile ranges were calculated and used to establish consensus. Overall, 32 and 29 panelists participated in the first and second rounds of the Delphi panel, respectively. Consensus was reached on treatment and HRU associated with a typical pacemaker implantation and complications. HRU was similar across regions, except for Japan, where panelists reported the longest duration of hospital stay in all scenarios. Infections were the most resource-intensive complications and were characterized by intravenous antibiotics days of 9.6?13.5 days and 21.3?29.2 days for pocket and lead infections respectively; laboratory and diagnostic tests, and system extraction and replacement procedures. DVT, on the other hand, was the least resource intensive complication. The results of the panel represent the views of the respondents who participated and may not be generalizable outside of this panel. The surveys were limited in scope and, therefore, did not include questions on management of acute complications (e.g. hematoma, pneumothorax). The Delphi technique provided a reliable and efficient approach to estimating resource utilization associated with chronic pacemaker complications. Estimates from the Delphi panel can be used to generate costs of pacemaker complications in various regions.

Re-use of explanted DDD pacemakers as VDD- clinical utility and cost effectiveness.

PubMed

Namboodiri, K K N; Sharma, Y P; Bali, H K; Grover, A

2004-01-01

Re-use of DDD pulse generators explanted from patients died of unrelated causes is associated with an additional cost of two transvenous leads if implanted as DDD itself, and high rate of infection according to some studies. We studied the clinical and economical aspects of reutilization of explanted DDD pacemakers programmed to VDD mode. Out of 28 patients who received VDD pacemaker during the period, October 2000- September 2001 in the Department of Cardiology, PGIMER, Chandigarh, 5 poor patients were implanted with explanted DDD pulse generators programmed to VDD mode. Each implantation was planned and carried out according to a standard protocol. The age ranged from 45 to 75 (mean-61) years. The indications for pacing were complete heart block (4) and second degree AV block (1). The clinical profile, costs and complications, if any were noted and followed up at regular intervals. The results were compared with patients who received new DDD pulse generators during this period. The additional cost for the atrial lead was not required in these patients. None of these patients had any local site infection. Compared to the two-lead system, the single lead system provided more rapid implantation and minimized complications associated with placement of an atrial lead. The explanted DDD pacemaker can be safely reused as VDD mode with same efficacy in selected patient population. This is associated with lower cost and complications compared to reimplantation as DDD itself.

The Use of Ultrasound to Improve Axillary Vein Access and Minimize Complications during Pacemaker Implantation.

PubMed

Esmaiel, Abdullah; Hassan, Jeremy; Blenkhorn, Fay; Mardigyan, Vartan

2016-05-01

The Agency for Healthcare Research and Quality in the United States recommends the use of ultrasound (US) for central venous access to improve patient outcomes. However, in a recent publication, US is still underutilized for axillary vein access during pacemaker implantation. We sought to describe a technique for US-guided axillary vein access during pacemaker implantation and to report complication rates and success rate. Retrospective data collection included success rate and complications on all pacemaker implants by one operator since implementing the systematic use of US at our institution, from November 2012 to January 2015. For the last 59 cases, data were collected prospectively to include time of venous access and number of attempts. A total of 403 consecutive patients were included in the analysis. Two leads were implanted in 255 cases and one lead was implanted in 148 cases. The rate of successful US-guided access was 99.25%. There were no access-related complications. The average number of venipuncture attempts was 1.18 per patient. The average time to obtain venous access was 2.24 minutes including the time to apply the sterile US sleeve. The described technique has the potential to improve the success rate of axillary vein access and minimize complications during pacemaker implantation. ©2016 Wiley Periodicals, Inc.

[Long-term effects of permanent pacemaker implantation on tricuspid valve regurgitation].

PubMed

Ren, Chong-lei; Wang, Yao; Wang, Rong; Li, Bo-jun; Geng, Ren-yi; Gao, Chang-qing

2012-08-14

To explore the long-term effects of permanent pacemaker implantation (PPI) on tricuspid valve regurgitation (TR) in Chinese patients so as to determine the incidence and related factors, evaluate its effects on heart structure and function and ascertain the exact mechanism of TR after PPI. A total of 430 patients undergoing permanent pacemaker replacement at our hospital between January 2000 and June 2011 were recruited. The patients with isolated atrial lead implantation procedures, significant heart valve disease or chronic obstructive pulmonary disease were excluded. The data of 108 patients who had Doppler echocardiograms performed before the first pacemaker implantation procedure and this pacemaker replacement procedure were obtained and retrospectively analyzed. According to the post-implant grade of TR, the patients were divided into two groups: normal tricuspid (n = 79) and abnormal tricuspid (n = 29). Their clinical characteristics and echocardiographic data between two groups were analyzed and compared. The mean follow-up time (from the first pacemaker implantation) was (13 ± 6) years (range: 4 - 34). Among 108 patients with initially normal tricuspid post-implant, 29 patients (26.9%) developed significant TR during the follow-up. In comparison to those in normal tricuspid group, the patients in abnormal tricuspid group had a longer time from the first pacemaker implantation ((16 ± 7) vs (12 ± 5) years, P = 0.003), more transtricuspid leads (1.31 ± 0.66 vs 1.10 ± 0.30, P = 0.026), larger right atrial size ((38 ± 7) vs (35 ± 4) mm, P = 0.028) and higher prevalence of mild TR and mitral valve regurgitation (MR) pre-implantation (TR: 21% vs 4%, P = 0.015, MR: 28% vs 5%, P = 0.003). The size of right atrium, right ventricle and left atrium in abnormal tricuspid group were more than those in normal tricuspid group. The prevalence of significant MR post-implantation in abnormal tricuspid group was higher than that in normal tricuspid group. The ejection fraction in abnormal tricuspid group was lower than that in normal tricuspid group during the follow-up. Abnormal TR after PPI during a long-term follow-up is quite common. The related factors include the time interval from the first pacemaker implantation, number of transtricuspid lead, right atrial size, mild TR and MR pre-implantation.

Retrospective analysis of mode survival, reliability of atrial sensing and incidence of atrial tachyarrhythmias in 307 single-lead VDD pacemaker patients.

PubMed

Zupan, Igor; Lipar, Luka; Zizek, David; Boute, Wim; Vidmar, Masa; Gabrijelcic, Tone; Rakovec, Peter; Brecelj, Ales

2006-10-01

The aim of this retrospective analysis was to investigate VDD mode survival, development of atrial tachyarrhythmias (AT), and long-term atrial sensing performance of VDD pacing systems. We implanted single-lead VDD pacemakers in patients with isolated atrioventricular block and performed a retrospective analysis of 307 patients who had their devices implanted between May 1994 and September 2001. In 39 patients (12.7%), the pacing mode had to be reprogrammed to a single-chamber ventricular pacing mode, mostly due to permanent AT. In 16 of these patients, the atrial sensing safety margin was less than 150%. The atrial sensing safety margin was insufficient, i.e. less than 100% in only seven patients. Although only 12 (3.9%) of the patients had a history of paroxysmal AT at the time of pacemaker implantation, 200 (65%) patients presented with AT during follow-up. The mean AT burden at the last follow-up was 2.5%. These data illustrate that single-lead VDD pacemakers can be applied without serious complications in a highly selected group of patients. Our main concern is the development of AT in a large part of our population. Over a 10-year period, two thirds of our patients presented with AT.

Failure rates of leads, pulse generators, and programmers have not diminished over the last 20 years: formal monitoring of performance is still needed. BILITCH Registry and STIMAREC.

PubMed

Kawanishi, D T; Song, S; Furman, S; Parsonnet, V; Pioger, G; Petitot, J C; Godin, J F

1996-11-01

Formal Monitoring of Performance is Still Needed. In order to detect trends in the number of device or component failures that have occurred among permanent pacemaker systems since the 1970s, we reviewed the data of the five largest pacemaker manufacturers from the Bilitch Registry of permanent pacemaker pulse generators, the Stimarec failure registry, the general accounting office summaries of the United States Veterans Administration (VA) Registry of Pacemaker Leads, and the Implantable Lead Registry, from the Cleveland Clinic Lead registry, and the recalls and safety alerts issued by the United States Food and Drug Administration (FDA) over the last 20 years. The definition of failure followed the criterion, or criteria, developed within each registry and differed significantly between the registries. The 20-year period between 1976 and 1995 was divided into 5-year quartiles (QT): QT 1 = 1976-1980; QT2 = 1981-1985; QT3 = 1986-1990; and QT4 = 1991-1995. For pulse generators, the number of models with failures in each quartile in the Bilitch Registry were: QT 1 = 9; QT 2 = 11; QT3 = 17; QT4 = 13. In Stimarec, the number of units reported as having reached a dangerous condition were: QT1 = 710; QT2 = 212; QT3 = 114; QT4 = 310. From the FDA reports, the number of units included in recalls or safety alerts were: QT3 = 6,085; QT4 = 135,766. For permanent pacemaker leads, the numbers of failed or dangerous leads recorded in Stimarec were: QT3 = 16; QT4 = 32. In the VA Registry, the number of models having a below average survival was 2/92 (2.7%). In the Implantable Lead Registry, the number of models having a below average survival was 3/21 (14%). In the Cleveland Clinic series, 6/13 (46%) of lead models were recognized to have some failure involving the conductor, insulation, or connector. In the FDA reports, the number of leads involved in either recall or safety alert were: QT3 = 20,354; QT4 = 332,105. For programmers, the number of units involved either in a recall or safety alert were: QT3 = 11,124; QT4 = 3,528. In all of these series, each of the five largest manufacturers had some models or units involved in each time period. This review of programs has revealed: 1. The incidence of failures, recalls, or safety alerts did not decline over time; and 2. Despite changes in technology, formal monitoring of pacemaker systems is still warranted.

Intermittent pacemaker dysfunction caused by digital mobile telephones.

PubMed

Naegeli, B; Osswald, S; Deola, M; Burkart, F

1996-05-01

This study was designed to evaluate possible interactions between digital mobile telephones and implanted pacemakers. Electromagnetic fields may interfere with normal pacemaker function. Development of bipolar sensing leads and modern noise filtering techniques have lessened this problem. However, it remains unclear whether these features also protect from high frequency noise arising from digital cellular phones. In 39 patients with an implanted pacemaker (14 dual-chamber [DDD], 8 atrial-synchronized ventricular-inhibited [VDD(R)] and 17 ventricular-inhibited [VVI(R)] pacemakers), four mobile phones with different levels of power output (2 and 8 W) were tested in the standby, dialing and operating mode. During continuous electrocardiographic monitoring, 672 tests were performed in each mode with the phones positioned over the pulse generator, the atrial and the ventricular electrode tip. The tests were carried out at different sensitivity settings and, where possible, in the unipolar and bipolar pacing modes as well. In 7 (18%) of 39 patients, a reproducible interference was induced during 26 (3.9%) of 672 tests with the operating phones in close proximity (<10 cm) to the pacemaker. In 22 dual-chamber (14 DDD, 8 VDD) pacemakers, atrial triggering occurred in 7 (2.8%) of 248 and ventricular inhibition in 5 (2.8%) of 176 tests. In 17 VVI(R) systems, pacemaker inhibition was induced in 14 (5.6%) of 248 tests. Interference was more likely to occur at higher power output of the phone and at maximal sensitivity of the pacemakers (maximal vs. nominal sensitivity, 6% vs. 1.8% positive test results, p = 0.009). When the bipolar and unipolar pacing modes were compared in the same patients, ventricular inhibition was induced only in the unipolar mode (12.5% positive test results, p = 0.0003). Digital mobile phones in close proximity to implanted pacemakers may cause intermittent pacemaker dysfunction with inappropriate ventricular tracking and potentially dangerous pacemaker inhibition.

Pacemaker Use in New Zealand - Data From the New Zealand Implanted Cardiac Device Registry (ANZACS-QI 15).

PubMed

Larsen, P D; Kerr, A J; Hood, M; Harding, S A; Hooks, D; Heaven, D; Lever, N A; Sinclair, S; Boddington, D; Tang, E W; Swampillai, J; Stiles, M K

2017-03-01

The New Zealand Cardiac Implanted Device Registry (Device) has recently been developed under the auspices of the New Zealand Branch of the Cardiac Society of Australia and New Zealand. This study describes the initial Device registry cohort of patients receiving a new pacemaker, their indications for pacing and their perioperative complications. The Device Registry was used to audit patients receiving a first pacemaker between 1 st January 2014 and 1 st June 2015. We examined 1611 patients undergoing first pacemaker implantation. Patients were predominantly male (59%), and had a median age of 70 years. The most common symptom for pacemaker implantation was syncope (39%), followed by dizziness (30%) and dyspnoea (12%). The most common aetiology for a pacemaker was a conduction tissue disorder (35%), followed by sinus node dysfunction (22%). Atrioventricular (AV) block was the most common ECG abnormality, present in 44%. Dual chamber pacemakers were most common (62%), followed by single chamber ventricular pacemakers (34%), and cardiac resynchronisation therapy - pacemakers (CRT-P) (2%). Complications within 24hours of the implant procedure were reported in 64 patients (3.9%), none of which were fatal. The most common complication was the need for reoperation to manipulate a lead, occurring in 23 patients (1.4%). This is the first description of data entered into the Device registry. Patients receiving a pacemaker were younger than in European registries, and there was a low use of CRT-P devices compared to international rates. Complications rates were low and compare favourably to available international data. Copyright © 2016 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

Percutaneous pacemaker or implantable cardioverter-defibrillator lead removal in an attempt to improve symptomatic tricuspid regurgitation.

PubMed

Nazmul, Mohammed N; Cha, Yong-Mei; Lin, Grace; Asirvatham, Samuel J; Powell, Brian D

2013-03-01

Pacemaker and implantable cardioverter-defibrillator (ICD) leads can cause tricuspid valve regurgitation (TR). Few data are available on the best management of significant TR that develops after pacemaker or ICD implantation and regarding any benefits of right ventricular (RV) lead extraction. We sought to determine the impact of RV lead removal on lead-induced TR. We reviewed all patients between 1 January 2000 and 31 December 2010 at the tertiary care hospital who had a preoperative indication of TR and underwent percutaneous extraction of an RV lead with the intent of trying to correct moderate or severe TR. Pre- and post-procedure echoes and clinical data were retrospectively reviewed. In the four patients identified, the RV lead was removed and placed in the coronary sinus to try to improve moderate or severe TR due to lead impingement. There was no significant improvement in the degree of TR except one patient where TR improved slightly from moderate to mild-moderate. All patients had a dilated tricuspid valve annulus by the time of lead extraction. Tricuspid annulus dilatation appeared to account for the persistent TR after RV lead removal. A greater degree of tricuspid valve annulus dilatation may be a marker and mechanism for irreversible lead-induced TR. Further studies are needed to determine whether surgical tricuspid valve repair or replacement combined with RV lead extraction would result in better outcomes than a percutaneous lead extraction approach.

Severe tricuspid regurgitation due to entrapment of the anterior leaflet of the valve by a permanent pacemaker lead: role of real time three-dimensional echocardiography.

PubMed

Nucifora, Gaetano; Badano, Luigi P; Allocca, Giuseppe; Gianfagna, Pasquale; Proclemer, Alessandro; Cinello, Margherita; Fioretti, Paolo M

2007-07-01

Pacemaker leads may impair tricuspid valve coaptation and they are a well-known cause of mild tricuspid regurgitation. Occasionally, right ventricular leads worsen tricuspid regurgitation over time and patients develop late-onset symptoms of right-sided heart failure. The exact mechanism of this clinical entity is rarely identifiable by 2D-echocardiography only. This case report details a patient with severe tricuspid regurgitation secondary to immobilization of the anterior leaflet of the tricuspid valve by a permanent ventricular pacing lead. The mechanism of regurgitation was clarified by real time three-dimensional echocardiography that showed the location of the ventricular lead and its interference with the tricuspid valve.

Sick sinus syndrome in HCN1-deficient mice.

PubMed

Fenske, Stefanie; Krause, Stefanie C; Hassan, Sami I H; Becirovic, Elvir; Auer, Franziska; Bernard, Rebekka; Kupatt, Christian; Lange, Philipp; Ziegler, Tilman; Wotjak, Carsten T; Zhang, Henggui; Hammelmann, Verena; Paparizos, Christos; Biel, Martin; Wahl-Schott, Christian A

2013-12-17

Sinus node dysfunction (SND) is a major clinically relevant disease that is associated with sudden cardiac death and requires surgical implantation of electric pacemaker devices. Frequently, SND occurs in heart failure and hypertension, conditions that lead to electric instability of the heart. Although the pathologies of acquired SND have been studied extensively, little is known about the molecular and cellular mechanisms that cause congenital SND. Here, we show that the HCN1 protein is highly expressed in the sinoatrial node and is colocalized with HCN4, the main sinoatrial pacemaker channel isoform. To characterize the cardiac phenotype of HCN1-deficient mice, a detailed functional characterization of pacemaker mechanisms in single isolated sinoatrial node cells, explanted beating sinoatrial node preparation, telemetric in vivo electrocardiography, echocardiography, and in vivo electrophysiology was performed. On the basis of these experiments we demonstrate that mice lacking the pacemaker channel HCN1 display congenital SND characterized by bradycardia, sinus dysrhythmia, prolonged sinoatrial node recovery time, increased sinoatrial conduction time, and recurrent sinus pauses. As a consequence of SND, HCN1-deficient mice display a severely reduced cardiac output. We propose that HCN1 stabilizes the leading pacemaker region within the sinoatrial node and hence is crucial for stable heart rate and regular beat-to-beat variation. Furthermore, we suggest that HCN1-deficient mice may be a valuable genetic disease model for human SND.

Pacemaker limitation of tachycardia in hypovolemic shock.

PubMed

Sparacino, Nicholas; Geninatti, Marilyn; Moore, Gregory

2011-11-01

A 49-year-old white man was admitted to the emergency department with nausea and diarrhea of 11 hours duration. He had experienced crampy abdominal pain as well. He reported that his stools had been dark and malodorous. He had no prior history of gastrointestinal disorders, nor travel, unusual oral or liquid intake. There was a remote history of alcohol abuse, but no hepatitis or cirrhosis. Recent alcohol intake was denied by the patient. He had no medical allergies. His past medical history was pertinent for a history of hypertension, congestive heart failure, and a dual chamber pacemaker insertion. There was no history of diabetes mellitus, smoking, or myocardial infarction. Medications included lisinopril, a small dose of aspirin daily, and thyroid supplement. Family history was negative for cardiomyopathy, sudden cardiac death, gastric or duodenal ulcers, colon cancer, or any congenital abnormalities.

The oral cavity is not a primary source for implantable pacemaker or cardioverter defibrillator infections

PubMed Central

2013-01-01

Background To test the hypothesis that the oral cavity is a potential source for implantable pacemaker and cardioverter defibrillators infections, the bacterial diversity on explanted rhythm heart management devices was investigated and compared to the oral microbiome. Methods A metagenomic approach was used to analyze the bacterial diversity on the surfaces of non-infected and infected pacemakers. The DNA from surfaces swaps of 24 non-infected and 23 infected pacemaker were isolated and subjected to bacterial-specific DNA amplification, single strand conformation polymorphism- (SSCP) and sequencing analysis. Species-specific primer sets were used to analyze for any correlation between bacterial diversity on pacemakers and in the oral cavity. Results DNA of bacterial origin was detected in 21 cases on infected pacemakers and assigned to the bacterial phylotypes Staphylococcus epidermidis, Propionibacterium acnes, Staphylococcus aureus, Staphylococcus schleiferi and Stapyhlococcus. In 17 cases bacterial DNA was found on pacemakers with no clinical signs of infections. On the basis of the obtained sequence data, the phylotypes Propionibacterium acnes, Staphylococcus and an uncultured bacterium were identified. Propionibacterium acnes and Staphylococcus epidermidis were the only bacteria detected in pacemeaker (n = 25) and oral samples (n = 11). Conclusions The frequency of the coincidental detection of bacteria on infected devices and in the oral cavity is low and the detected bacteria are highly abundant colonizers of non-oral human niches. The transmission of oral bacteria to the lead or device of implantable pacemaker or cardioverter defibrillators is unlikely relevant for the pathogenesis of pacemaker or cardioverter defibrillators infections. PMID:23575037

Magnetic Resonance Imaging in Nondependent Pacemaker Patients with Pacemakers and Defibrillators with a Nearly Depleted Battery.

PubMed

Okamura, Hideo; Padmanabhan, Deepak; Watson, Robert E; Dalzell, Connie; Acker, Nancy; Jondal, Mary; Romme, Abby L; Cha, Yong-Mei; Asirvatham, Samuel J; Felmlee, Joel P; Friedman, Paul A

2017-05-01

Magnetic resonance imaging (MRI) in patients with non-MRI-conditional cardiac implantable electronic devices (CIEDs) has been shown to be safe when performed under closely monitored protocols. However, the safety of MRI in patients with devices with a nearly depleted battery has not been reported. Prospective data were collected between January 2008 and May 2015 in patients with non-MRI-conditional CIEDs undergoing clinically indicated MRI under institutional protocol. Patients who were pacemaker dependent were excluded. Patients whose devices were at elective replacement indicator (ERI) at the time of MRI or close to ERI (ERI or replacement for battery depletion within 3 months of scan) were identified through database review and analyzed for clinical events. MRI scans (n = 569) were performed in 442 patients. Of these, we identified 13 scans performed with a nearly depleted battery in nine patients. All scans with implantable cardioverter defibrillators (ICDs, n = 9) were uneventful. However, two scans with pacemakers close to ERI resulted in a power-on-reset (PoR) event. One scan with a pacemaker close to ERI that was programmed to DOO mode reached ERI during MRI and automatically changed to VVI mode. Additionally, one scan with a pacemaker at ERI did not allow programming. All pacemakers with events were implanted before 2005. Patients with pacemakers and ICDs with a nearly depleted battery can safely undergo MRI when patients are not pacemaker dependent. Attention should be paid because old devices can result in PoR or ERI during MRI, which may lead to oversensing and inhibition of pacing. © 2017 Wiley Periodicals, Inc.

Permanent transvenous pacemaker implantation in an Ibizan hound cross with persistent atrial standstill

PubMed Central

MacAulay, Kevin

2002-01-01

An Ibizan hound cross was referred with a 1-year history of syncope and exercise intolerance. An electrocardiogram showed bradycardia and no P waves; atrial standstill was diagnosed. A permanent artificial endocardial pacemaker was implanted. The lead dislodged and was reimplanted into the right ventricular apex. Capture was once again achieved. PMID:12395764

Runaway pacemaker: a forgotten phenomenon?

PubMed

Ortega, Daniel F; Sammartino, M Victoria; Pellegrino, Graciela M M; Barja, Luis D; Albina, Gaston; Segura, Eliseo V; Balado, Roberto; Laiño, Ruben; Giniger, Alberto G

2005-11-01

Runaway is an uncommon pacemaker dysfunction, characterized by fast and erratic spikes at non-physiological rates. This infrequent but potentially lethal failure mode may be related to low battery voltage. Four single chamber pacemaker patients were analyzed (Medtronic Minix ST 8330, Minneapolis, MN, had been implanted in two patients and two CPI Triumph VR 1124, St Paul, MN, in the other two). They had been admitted because of presyncopal episodes. Typical high rate stimuli at 2000 ppm alternating with pacing at 60-65 ppm were recorded in all ECGs. Lead system tests were normal. The pulse generators had to be replaced.

Clinical assessment of pacemaker power sources

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bilitch, M.; Parsonnet, V.; Furman, S.

1980-01-01

The development of power sources for cardiac pacemakers has progressed from a 15-year usage of mercury-zinc batteries to widely used and accepted lithium cells. At present, there are about 6 different types of lithium cells incorporated into commercially distributed pacemakers. The authors reviewed experience over a 5-year period with 1711 mercury-zinc, 130 nuclear (P238) and 1912 lithium powered pacemakers. The lithium units have included 698 lithium-iodide, 270 lithium-silver chromate, 135 lithium-thionyl chloride, 31 lithium-lead and 353 lithium-cupric sulfide batteries. 57 of the lithium units have failed (91.2% component failure and 5.3% battery failure). 459 mercury-zinc units failed (25% component failuremore » and 68% battery depletion). The data show that lithium powered pacemaker failures are primarily component, while mercury-zinc failures are primarily battery related. It is concluded that mercury-zinc powered pulse generators are obsolete and that lithium and nuclear (P238) power sources are highly reliable over the 5 years for which data are available. 3 refs.« less

Right ventricular pacemaker lead position is associated with differences in long-term outcomes and complications.

PubMed

Witt, Chance M; Lenz, Charles J; Shih, Henry H; Ebrille, Elisa; Rosenbaum, Andrew N; van Zyl, Martin; Aung, Htin; Manocha, Kevin K; Deshmukh, Abhishek J; Hodge, David O; Mulpuru, Siva K; Cha, Yong-Mei; Espinosa, Raul E; Asirvatham, Samuel J; Mcleod, Christopher J

2017-08-01

Cardiac pacing from the right ventricular apex is associated with detrimental long-term effects and nonapical pacing locations may be associated with improved outcomes. There is little data regarding complications with nonapical lead positions. The aim of this study was to assess long-term outcomes and lead-related complications associated with differing ventricular lead tip position. All adult patients who underwent dual-chamber pacemaker implantation from 2004 to 2014 were included if they had postprocedure chest radiographs amenable to lead position determination. Long-term outcomes and lead-related complication rates were recorded. These were compared at 5 years between: (1) apical and septal leads, (2) apical and nonseptal nonapical (NSNA), and (3) apical and septal with >40% ventricular pacing. We retrospectively evaluated 3,450 patients, which included 238 with a septal position and 733 with NSNA lead positions. Septal lead position was associated with a lower mortality compared to apical leads (24% vs. 31%, P = 0.02). In patients with greater than 40% pacing, septal leads were associated with significantly higher rates of incident atrial fibrillation compared to apical leads (49% vs. 34%, P = 0.04). NSNA positions were associated with a significantly higher rate of lead dislodgement (4% vs. 2%, P = 0.005) and need for revision (8% vs. 5%, P = 0.005). Septal pacemaker lead position is associated with a lower mortality compared to apically placed leads, but a higher incidence of atrial fibrillation with higher percentage ventricular pacing. NSNA lead locations are associated with more complications and should be avoided. © 2017 Wiley Periodicals, Inc.

Animal Models of Jet Lag

DTIC Science & Technology

2012-01-20

surgically inserted into the pineal gland and connected to a peristaltic pump that delivers saline solution at low rate and to a outlet tubing that delivers...Journal of Pineal Research. 48(3):290- 6,2010. 2. "Orcadian Regulation of Pineal Gland Rhythmicity", Jimo Borjigin, L. Samantha Zhang, Anda-Alexandra...specializes in the longitudinal monitoring of pineal melatonin secretion for weeks at a time to decipher mechanisms of circadian pacemaker entrainment

Early Performance and Safety of the Micra Transcatheter Pacemaker in Pigs.

PubMed

Bonner, Matthew; Eggen, Michael; Haddad, Tarek; Sheldon, Todd; Williams, Eric

2015-11-01

The Micra® Transcatheter Pacing System (TPS; Medtronic Inc., Minneapolis, MN, USA) is a miniaturized single-chamber pacemaker system that is delivered via catheter through the femoral vein. In this study, the electrical performance was compared between the TPS and a traditional leaded pacemaker. In addition, the safety profile of the two systems was compared by thorough monitoring for a number of adverse events. The TPS was implanted in the right ventricular apex of 10 Yucatan mini pigs and a Medtronic single-lead pacemaker (SLP) was implanted in the right ventricular apex of another 10 pigs and connected to a traditional pacemaker. The electrical performance of all devices was monitored for 12 weeks. The safety profile of each system was characterized using x-ray, computed tomography, ultrasound, blood work, and necropsy to monitor for a variety of adverse events. At implant the mean pacing thresholds were 0.58 ± 0.17 V @0.24 ms and 0.75 ± 0.29 V @0.21 ms for the TPS and the SLP respectively. After 12 weeks, mean thresholds were 0.94 ± 0.46 V and 1.85 ± 0.75 V (P < 0.0001). There were two pulmonary emboli that were small and past the tertiary branch, and one occurred in each arm. There were also two infections with one in each arm. There were no dislodgements (macro or micro), tissue injury, tamponade, or valve injury. Overall, despite the 10-fold size reduction of the Micra TPS, it appears to perform similarly and have a similar safety profile to a traditional pacemaker system. © 2015 Medtronic PLC. Pacing and Clinical Electrophysiology published by Wiley Periodicals, Inc.

THE EFFECT OF RIGHT VENTRICULAR PACEMAKER LEAD POSITION ON FUNCTIONAL STATUS IN PATIENTS WITH PRESERVED LEFT VENTRICULAR EJECTION FRACTION.

PubMed

Mitov, Vladimir M; Perisic, Zoran; Jolic, Aleksandar; Kostic, Tomislav; Aleksic, Aleksandar; Aleksic, Zeljka

2016-07-01

The study was aimed at assessing the difference between the right ventricle apex versus the right ventricular outflow tract lead position in functional capacity in the patients with the preserved left ventricular ejection fraction after 12 months of pacemaker stimulation. This was a prospective, randomized, follow-up study, which lasted for 12 months. The study sample included 132 consecutive patients who were implanted with permanent anti-bradicardiac pacemaker. Regarding the right ventricular lead position the patients were divided into two groups: the right ventricle apex group consisting of 61 patients with right ventricular apex lead position. The right ventricular outflow tract group included 71 patients with right ventricular outflow tract lead position. Functional capacity was assessed by Minnesota Living With Heart Failure score, New York Heart Association class and Six Minute Walk Test. Left ventricular ejection fraction was assessed by echocardiography. Minnesota Living With Heart Failure score and New York Heart Association class had a statistically significant improvement in both study groups. The patients from right ventricle apex group walked 20.95% (p=O.03) more in comparison to starting values. The patients from right ventricular outflow tract group walked only 13.63% (p=0.09) longer distance than the startingoneConclusion. Analysis of tests of functional status New York Heart Association class and Minnesota Living With Heart Failure questionnaire showed an even improvement in the right ventricle apex and right ventricular outflow tract groups. Analysis of 6 minute walk test showed that only the patients with the preserved left ventricular ejection fraction from the right ventricle apex group had a significant improvement after 12 months of pacemaker stimulation..

Long-Term Follow-Up of Children with Heart Block Born from Mothers with Systemic Lupus Erythematosus: A Retrospective Study from the Database Pediatric and Congenital Heart Disease in University Hospitals Leuven.

PubMed

DE Caluwé, Eva; VAN DE Bruaene, Alexander; Willems, Rik; Troost, Els; Gewillig, Marc; Rega, Filip; Budts, Werner

2016-09-01

Children from mothers with systemic lupus erythematosus are frequently born with congenital heart block. This study aimed at evaluating long-term outcome because long-term data are scarce. In the database of pediatric and congenital heart disease (University Hospitals Leuven), 19 children from systemic lupus erythematosus mothers and who were born with or developed atrioventricular block were identified. All records were reviewed for disease course and outcome. Median follow-up time was 7 years (interquartile ranges [IQR] 4.5-13 years). One child had no heart block at birth and developed only a first-degree block during follow-up. One had a second-degree heart block and developed a complete heart block. Seventeen patients (89%) were born with a complete heart block. Seventeen patients (89%) needed a definitive pacemaker. In all, epicardial leads were used at first implantation. Eighty-two percent received their pacemaker in the first year of life. The first battery had a median lifetime of 5 years (IQR 3.5-5 years), the second 6 years (IQR 4.5-6.3 years), and the third 5 years (IQR 5-6 years). Note that 47% of patients needed a lead replacement due to lead problems. Only one pericardial tamponade after pacemaker implantation. No device or lead infections occurred. The left ventricular systolic function at latest follow-up was normal for all. No patients died. In children with heart block born from systemic lupus erythematosus mothers, an early need for pacemaker implantation was documented. The overall battery life was acceptable, but there was a high need for lead replacement. Complication rate was low. Late outcome was good. © 2016 Wiley Periodicals, Inc.

Venous access and long-term pacemaker lead failure: comparing contrast-guided axillary vein puncture with subclavian puncture and cephalic cutdown.

PubMed

Chan, Ngai-Yin; Kwong, Nim-Pong; Cheong, Adrian-Piers

2017-07-01

Existing data on the relationship between venous access and long-term pacemaker lead failure (PLF) are scarce and inconsistent. We aim to study the hypothesis that contrast-guided axillary vein puncture (AP) is better than subclavian puncture (SP) and similar to cephalic vein cutdown (CV) in the incidence of PLF and the success rate of AP is higher than CV. The case records of 409 patients with 681 implantable pacemaker leads were reviewed. Two hundred and fifty-two, 217, and 212 leads were implanted via AP, CV, and SP, respectively. With a mean follow-up of 73.6 ± 33.1 months, 20 (2.9%) PLF occurred. Three (1.2%), 5 (2.3%), and 12 (5.6%) PLF occurred in the AP, CV, and SP groups, respectively. On multivariate Cox regression analysis, the only independent predictor for PLF was the use of SP instead of AP (AP vs. SP; hazard ratio: 0.261; 95% confidence interval: 0.071-0.954, P = 0.042). The success rate of CV (78.2%) was significantly lower than those of AP (97.6%) and SP (96.8%) (P < 0.001). Compared with SP, the use of AP but not CV independently predicted a lower risk of PLF. The success rates in achieving venous accesses were similar between AP and SP, but significantly lower for CV. Axillary vein puncture may thus be considered the venous access of choice for pacemaker lead implantation. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

Hemodynamic instability after pulmonary veins isolation in a patient with dual chamber pacemaker: The phantom injury of the ventricular lead.

PubMed

Kiuchi, Márcio Galindo; Lobato, Guilherme Miglioli; Chen, Shaojie

2017-06-01

The standard treatment of sinus node dysfunction (SND) is the pacemaker implantation, and the ideal methodology for the management of atrial fibrillation (AF) is rhythm control, but this is sometimes very hard to accomplish. For such actions, complete isolation of all pulmonary veins (PVI) is currently widely accepted as the best endpoint. In this case, we report a female patient, 81 years old, with controlled hypertension, without coronary artery disease, bearer of bilateral knee replacement, and dual chamber pacemaker implanted 1.5 years ago owing to sinus node disease, presenting the following symptoms: presyncope episodes associated with sustained irregular palpitation tachycardia. The evaluation of the pacemaker-recorded episodes of atrial fibrillation, the echocardiogram-presented normal systolic function and measurements, as well as the resting myocardial scintigraphy and with drug use did not demonstrate ischemia and/or fibrosis. The patient was in use of valsartan 320 mg daily, amlodipine 10 mg daily, sotalol hydrochloride 120 mg 2 times daily, and dabigatran 110 mg 2 times daily. At the end of the PVI, the patient presented hemodynamic instability, with a decrease in heart rate to 30 bpm and invasive arterial blood pressure to 60/30 mmHg. The pericardial puncture was quickly carried out with the possibility of cardiac tamponade as the first hypothesis, but no pericardial effusion was found. Next, we detected acute capture loss from the ventricular pacemaker lead, unvarying with high voltage and pulse width, even with stable impedance, sense and keeping the same position visualized by fluoroscopy. And there was soon afterwards induction of sustained ventricular tachycardia degenerating to spontaneous ventricular fibrillation. Electrical cardioversion-defibrillation was performed with 200J, and the sinus rhythm was reestablished, but there was a dead short, and the pacemaker generator was burned and disabled. So, we can speculate that application of atrial radiofrequency for PVI diffused through the tissues, affecting in some way the tip of the ventricular electrode, causing a microlesion in this structure and making it impossible to capture the right ventricle by the pacemaker. As we cannot see it, we can call it of phantom injury of the ventricular lead.

Current use of implantable electrical devices in Sweden: data from the Swedish pacemaker and implantable cardioverter-defibrillator registry.

PubMed

Gadler, Fredrik; Valzania, Cinzia; Linde, Cecilia

2015-01-01

The National Swedish Pacemaker and Implantable Cardioverter-Defibrillator (ICD) Registry collects prospective data on all pacemaker and ICD implants in Sweden. We aimed to report the 2012 findings of the Registry concerning electrical devices implantation rates and changes over time, 1 year complications, long-term device longevity and patient survival. Forty-four Swedish implanting centres continuously contribute implantation of pacemakers and ICDs to the Registry by direct data entry on a specific website. Clinical and technical information on 2012 first implants and postoperative complications were analysed and compared with previous years. Patient survival data were obtained from the Swedish population register database. In 2012, the mean pacemaker and ICD first implantation rates were 697 and 136 per million inhabitants, respectively. The number of cardiac resynchronization therapy (CRT) first implantations/million capita was 41 (CRT pacemakers) and 55 (CRT defibrillators), with only a slight increase in CRT-ICD rate compared with 2011. Most device implantations were performed in men. Complication rates for pacemaker and ICD procedures were 5.3 and 10.1% at 1 year, respectively. Device and lead longevity differed among manufacturers. Pacemaker patients were older at the time of first implant and had generally worse survival rate than ICD patients (63 vs. 82% after 5 years). Pacemaker and ICD implantation rates seem to have reached a level phase in Sweden. Implantable cardioverter-defibrillator and CRT implantation rates are very low and do not reflect guideline indications. Gender differences in CRT and ICD implantations are pronounced. Device and patient survival rates are variable, and should be considered when deciding device type. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

Pacemakers handshake synchronization mechanism of mammalian respiratory rhythmogenesis

PubMed Central

Wittmeier, Steffen; Song, Gang; Duffin, James; Poon, Chi-Sang

2008-01-01

Inspiratory and expiratory rhythms in mammals are thought to be generated by pacemaker-like neurons in 2 discrete brainstem regions: pre-Bötzinger complex (preBötC) and parafacial respiratory group (pFRG). How these putative pacemakers or pacemaker networks may interact to set the overall respiratory rhythm in synchrony remains unclear. Here, we show that a pacemakers 2-way “handshake” process comprising pFRG excitation of the preBötC, followed by reverse inhibition and postinhibitory rebound (PIR) excitation of the pFRG and postinspiratory feedback inhibition of the preBötC, can provide a phase-locked mechanism that sequentially resets and, hence, synchronizes the inspiratory and expiratory rhythms in neonates. The order of this handshake sequence and its progression vary depending on the relative excitabilities of the preBötC vs. the pFRG and resultant modulations of the PIR in various excited and depressed states, leading to complex inspiratory and expiratory phase-resetting behaviors in neonates and adults. This parsimonious model of pacemakers synchronization and mutual entrainment replicates key experimental data in vitro and in vivo that delineate the developmental changes in respiratory rhythm from neonates to maturity, elucidating their underlying mechanisms and suggesting hypotheses for further experimental testing. Such a pacemakers handshake process with conjugate excitation–inhibition and PIR provides a reinforcing and evolutionarily advantageous fail-safe mechanism for respiratory rhythmogenesis in mammals. PMID:19008356

A cardiac implantable device infection by Raoultella planticola in an immunocompromized patient.

PubMed

Adjodah, Chandra; D'Ivernois, Chistophe; Leyssene, David; Berneau, Jean-Baptiste; Hemery, Yann

2017-02-01

Introduction. Infection of cardiac implantable electronic devices is a severe condition associated with high mortality, particularly in patients who are dependent upon heart-pacing devices. Staphylococci are found in 70 % of reported cases. Case presentation. We report the case of a cardiac-pacemaker infection in a 79-year-old man, cumulating a history of rheumatoid arthritis treated by corticosteroids and methotrexate by a recently identified micro-organism: Raoultella planticola . He presented local signs of infection on his VVI pacemaker implantation site and underwent urgent pocket device replacement under cefamandole antibioprophylaxis. On incision thick pus oozed out. It was necessary to perform a complete hardware extraction comprising the pulse generator and the ancient lead. Pus was inoculated into aerobic and anaerobic culture vials and Gram staining unveiled Gram-negative rods. Microbiology analysis identified the organism as R. planticola. A new pacing device was inserted on the contrlateral pectoral region. Ciprofloxacin enabled full recovery. A literature review concerning this pathogen revealed that it is involved in severe infections such as bloodstream infections, peritonitis, cellulitis, pneumonia and lung abscesses, and urinary tract infections. In these case reports, underlying co-morbidities were identified such as solid active neoplasia, recent chemotherapy, corticosteroids, solid-organ-recipient patients and recent open surgery. Conclusion. R. planticola is a serious emerging pathogen and contributes to the burden of various infectious conditions. Its pathogenicity and occurrence should be known by clinicians and a high level of awareness is necessary to precisely identify it provide the correct antibiotic regimen.

Spanish Pacemaker Registry. Twelfth Official Report of the Spanish Society of Cardiology Working Group on Cardiac Pacing (2014).

PubMed

Cano Pérez, Óscar; Pombo Jiménez, Marta; Coma Samartín, Raúl

2015-12-01

This report describes the results of the analysis of pacemaker implant and replacement data submitted to the Spanish Pacemaker Registry in 2014, with special reference to pacing mode selection. The report is based on the processing of information provided by the European Pacemaker Patient Identification Card. Information was received from 117 hospitals, with a total of 12 358 cards, representing 34% of estimated activity. Use of conventional generators and resynchronization devices was 784 and 64.4 units per million population, respectively. The mean age of patients receiving an implant was 77.3 years. Men received 59% of implants and 56.4% of replacements. Most patients receiving generator implants and replacements were in the age range 80 to 89 years. Most endocardial leads used were bipolar, and 84.2% had an active fixation system. Pacing was in VVI/R mode despite being in sinus rhythm in 24.7% of patients with sick sinus syndrome and 24% of those with atrioventricular block. The use of pacemaker generators and resynchronization devices per million population continued to increase. Most implanted leads had active fixation and approximately 20% had magnetic resonance imaging protection. Age and sex directly influenced pacing mode selection, which could have been improved in more than 20% of cases. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Conduction Abnormalities and Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement Using the Repositionable LOTUS Device: The United Kingdom Experience.

PubMed

Rampat, Rajiv; Khawaja, M Zeeshan; Hilling-Smith, Roland; Byrne, Jonathan; MacCarthy, Philip; Blackman, Daniel J; Krishnamurthy, Arvindra; Gunarathne, Ashan; Kovac, Jan; Banning, Adrian; Kharbanda, Raj; Firoozi, Sami; Brecker, Stephen; Redwood, Simon; Bapat, Vinayak; Mullen, Michael; Aggarwal, Suneil; Manoharan, Ganesh; Spence, Mark S; Khogali, Saib; Dooley, Maureen; Cockburn, James; de Belder, Adam; Trivedi, Uday; Hildick-Smith, David

2017-06-26

The authors report the incidence of pacemaker implantation up to hospital discharge and the factors influencing pacing rate following implantation of the LOTUS bioprosthesis (Boston Scientific, Natick, Massachusetts) in the United Kingdom. Transcatheter aortic valve replacement (TAVR) is associated with a significant need for permanent pacemaker implantation. Pacing rates vary according to the device used. The REPRISE II (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System) trial reported a pacing rate of 29% at 30 days after implantation of the LOTUS device. Data were collected retrospectively on 228 patients who had the LOTUS device implanted between March 2013 and February 2015 across 10 centers in the United Kingdom. Twenty-seven patients (12%) had pacemakers implanted pre-procedure and were excluded from the analysis. Patients were aged 81.2 ± 7.7 years; 50.7% were male. The mean pre-procedural QRS duration was 101.7 ± 20.4 ms. More than one-half of the cohort (n = 111, 55%) developed new left bundle branch block (LBBB) following the procedure. Permanent pacemakers were implanted in 64 patients (32%) with a median time to insertion of 3.0 ± 3.4 days. Chief indications for pacing were atrioventricular (AV) block (n = 46, 72%), or LBBB with 1st degree AV block (n = 11, 17%). Amongst those who received a pacemaker following TAVR the pre-procedural electrocardiogram findings included: No conduction disturbance (n = 41, 64%); 1st degree AV block (n = 10, 16%); right bundle branch block (n = 6, 9%) and LBBB (n = 5, 8%). LBBB (but not permanent pacemaker) occurred more frequently in patients who had balloon aortic valvuloplasty before TAVR (odds ratio [OR]: 1.25; p = 0.03). Pre-procedural conduction abnormality (composite of 1st degree AV block, hemiblock, right bundle branch block, LBBB) was independently associated with the need for permanent pacemaker (OR: 2.54; p = 0.048). The absence of aortic valve calcification was also associated with a higher pacing rate (OR: 0.55; p = 0.031). Multivariate regression analysis did not show an independent association between depth of implant, valve oversizing, balloon post-dilatation, and the need for pacing post-procedure. Following implantation of the repositionable LOTUS valve, 55% of patients developed LBBB and 32% of patients required a pacemaker during their index hospital admission. Patients with pre-procedural conduction disturbance and non-calcified aortic valves were more likely to need pacing. No other anatomic features were identified with increased pacing requirement with the LOTUS device. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

Mechanisms underlying the cardiac pacemaker: the role of SK4 calcium-activated potassium channels

PubMed Central

Weisbrod, David; Khun, Shiraz Haron; Bueno, Hanna; Peretz, Asher; Attali, Bernard

2016-01-01

The proper expression and function of the cardiac pacemaker is a critical feature of heart physiology. The sinoatrial node (SAN) in human right atrium generates an electrical stimulation approximately 70 times per minute, which propagates from a conductive network to the myocardium leading to chamber contractions during the systoles. Although the SAN and other nodal conductive structures were identified more than a century ago, the mechanisms involved in the generation of cardiac automaticity remain highly debated. In this short review, we survey the current data related to the development of the human cardiac conduction system and the various mechanisms that have been proposed to underlie the pacemaker activity. We also present the human embryonic stem cell-derived cardiomyocyte system, which is used as a model for studying the pacemaker. Finally, we describe our latest characterization of the previously unrecognized role of the SK4 Ca2+-activated K+ channel conductance in pacemaker cells. By exquisitely balancing the inward currents during the diastolic depolarization, the SK4 channels appear to play a crucial role in human cardiac automaticity. PMID:26725737

Mechanisms underlying the cardiac pacemaker: the role of SK4 calcium-activated potassium channels.

PubMed

Weisbrod, David; Khun, Shiraz Haron; Bueno, Hanna; Peretz, Asher; Attali, Bernard

2016-01-01

The proper expression and function of the cardiac pacemaker is a critical feature of heart physiology. The sinoatrial node (SAN) in human right atrium generates an electrical stimulation approximately 70 times per minute, which propagates from a conductive network to the myocardium leading to chamber contractions during the systoles. Although the SAN and other nodal conductive structures were identified more than a century ago, the mechanisms involved in the generation of cardiac automaticity remain highly debated. In this short review, we survey the current data related to the development of the human cardiac conduction system and the various mechanisms that have been proposed to underlie the pacemaker activity. We also present the human embryonic stem cell-derived cardiomyocyte system, which is used as a model for studying the pacemaker. Finally, we describe our latest characterization of the previously unrecognized role of the SK4 Ca(2+)-activated K(+) channel conductance in pacemaker cells. By exquisitely balancing the inward currents during the diastolic depolarization, the SK4 channels appear to play a crucial role in human cardiac automaticity.

High ventricular lead impedance of a DDD pacemaker after cranial magnetic resonance imaging.

PubMed

Baser, Kazim; Guray, Umit; Durukan, Mine; Demirkan, Burcu

2012-09-01

Management of electromagnetic interference in the form of magnetic resonance imaging (MRI) in patients with pacemakers (PMs) may be challenging. Serious consequences, especially in PM-dependent patients, may be encountered. Changes in device programming, asynchronous pacing, heating of the lead tip(s), and increased thresholds or even device dislocation may be experienced. We report of a patient with a DDD PM who underwent an emergent MRI, after which there was an increase in ventricular impedance as well as increased cardiac biomarkers. ©2011, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.

The influence of anatomical and physiological parameters on the interference voltage at the input of unipolar cardiac pacemakers in low frequency electric fields.

PubMed

Joosten, S; Pammler, K; Silny, J

2009-02-07

The problem of electromagnetic interference of electronic implants such as cardiac pacemakers has been well known for many years. An increasing number of field sources in everyday life and occupational environment leads unavoidably to an increased risk for patients with electronic implants. However, no obligatory national or international safety regulations exist for the protection of this patient group. The aim of this study is to find out the anatomical and physiological worst-case conditions for patients with an implanted pacemaker adjusted to unipolar sensing in external time-varying electric fields. The results of this study with 15 volunteers show that, in electric fields, variation of the interference voltage at the input of a cardiac pacemaker adds up to 200% only because of individual factors. These factors should be considered in human studies and in the setting of safety regulations.

Successful treatment of pacemaker-induced stricture and thrombosis of the cranial vena cava in two dogs by use of anticoagulants and balloon venoplasty.

PubMed

Cunningham, Suzanne M; Ames, Marisa K; Rush, John E; Rozanski, Elizabeth A

2009-12-15

2 castrated male Labrador Retrievers (dogs 1 and 2) were evaluated 3 to 4 years after placement of a permanent pacemaker. Dog 1 was evaluated because of a large volume of chylous pleural effusion. Dog 2 was admitted for elective replacement of a pacemaker. Dog 1 had mild facial swelling and a rapidly recurring pleural effusion. Previously detected third-degree atrioventricular block had resolved. Cranial vena cava (CVC) syndrome secondary to pacemaker-induced thrombosis and stricture of the CVC was diagnosed on the basis of results of ultrasonography, computed tomography, and venous angiography. Dog 2 had persistent third-degree atrioventricular block. Intraluminal caval stricture and thrombosis were diagnosed at the time of pacemaker replacement. Radiographic evidence of pleural effusion consistent with CVC syndrome also was detected at that time. Dog 1 improved after treatment with unfractionated heparin and a local infusion of recombinant tissue-plasminogen activator. Balloon venoplasty was performed subsequently to relieve the persistent caval stricture. In dog 2, balloon dilatation of the caval stricture was necessary to allow for placement of a new pacing lead. Long-term anticoagulant treatment was initiated in both dogs. Long-term (> 6 months) resolution of clinical signs was achieved in both dogs. Thrombosis and stricture of the CVC are possible complications of a permanent pacemaker in dogs. Findings suggested that balloon venoplasty and anticoagulation administration with or without thrombolytic treatment can be effective in the treatment of dogs with pacemaker-induced CVC syndrome.

Percutaneously injectable fetal pacemaker: electrodes, mechanical design and implantation.

PubMed

Zhou, Li; Chmait, Ramen; Bar-Cohen, Yaniv; Peck, Raymond A; Loeb, Gerald E

2012-01-01

We are developing a self-contained cardiac pacemaker with a small, cylindrical shape (~3 × 20 mm) that permits it to be implanted percutaneously into a fetus to treat complete heart block and consequent hydrops fetalis, which is otherwise fatal. The device uses off-the-shelf components including a rechargeable lithium cell and a highly efficient relaxation oscillator encapsulated in epoxy and glass. A corkscrew electrode made from activated iridium can be screwed into the myocardium, followed by release of the pacemaker and a short, flexible lead entirely within the chest of the fetus to avoid dislodgement from fetal movement. The feasibility of implanting the device percutaneously under ultrasonic imaging guidance was demonstrated in acute adult rabbit experiments.

Troponin T elevation after permanent pacemaker implantation.

PubMed

Chen, Xueying; Yu, Ziqing; Bai, Jin; Hu, Shulan; Wang, Wei; Qin, Shengmei; Wang, Jingfeng; Sun, Zhe; Su, Yangang; Ge, Junbo

2017-08-01

The objective of the study is to study the incidence, significance, and factors associated with cardiac troponin T (CTNT) elevation after pacemaker implantation. Three hundred seventy-four patients (104 single-chamber pacemakers or ICD, 243 dual-chamber pacemakers, and 27 cardiac resynchronization therapy/cardiac resynchronization therapy defibrillator) who had normal levels of CTNT at baseline and underwent implantation of a permanent pacemaker system were included in this study. Serum levels of CTNT were measured at baseline, 6 and 24 h after the implantation procedure. The median of CTNT levels increased from 0.012 ng/mL at baseline to 0.032 and 0.019 ng/mL at 6 and 24 h after the procedure, respectively (all p < 0.0001). Elevated CTNT levels were noted in 208 patients (55.6%) at 6 h after the implantation, among which 29 patients (7.8%) had CTNT levels exceeding the range of minimal myocardial damage (>0.09 ng/mL). After 1-year follow-up, the incidence of complications including dislodgement of the lead, pocket infection, pneumothorax, hemothorax, and vein thrombus and cardiac outcomes including hospitalization of heart failure, coronary artery disease, arrhythmia, and cardiovascular mortality was not significantly different between the normal and elevated CTNT groups at 6 h after the procedure. By logistic regression analysis, gender, N-terminal pro-B type natriuretic peptide (NT-pro-BNP) at baseline, left ventricular ejection fractions (LVEF), estimated glomerular filtration rate (eGFR), and fluoroscopy time were independently associated with CTNT elevation after adjusted for age, pacemaker types, right ventricle lead location (RVA or RVOT), heart function, and left ventricular end systolic dimension. Pacemaker implantation was found to be accompanied with CTNT elevation in 55.6% of the patients at 6 h after the procedure, and its kinetics were fast, which might not be related to the complications and adverse cardiac outcomes within 1 year of follow-up. Moreover, gender, NT-pro-BNP at baseline, LVEF, eGFR, and fluoroscopy time were found to be independent predictors of CTNT elevation.

Frozen shoulder syndrome associated with subpectoral defibrillator implantation.

PubMed

Burke, M C; Drinan, K; Kopp, D E; Kall, J G; Verdino, R J; Paydak, H; Wilber, D J

1999-10-01

Pectoral implantation of transvenous non-thoracotomy internal cardioverter defibrillators (ICD) has resulted in very few complications whether placed subpectorally or subcutaneously. We report the case of a 68 year old man with a subpectorally implanted MINI-plus (Cardiac Pacemakers, Incorporated, St. Paul, Mn.) transvenous ICD who developed nearly instantaneous severe ipsilateral shoulder pain and immobilization. The symptoms progressed despite aggressive physical therapy. We elected to remove the device from the pectoral site and place it in a traditional abdominal position due to the severity, duration and refractoriness of his symptoms. This procedure utilized the chronic Endotak DSP (Model 0125, Cardiac Pacemakers, Incorporated) transvenous lead, a compatible Endotak DSP lead extender (Model 6952, Cardiac Pacemakers, Incorporated) and the above described ICD. Immediate relief of symptoms was accomplished by relocation of the device to an abdominal site. This intervention should be reserved for patients with severely debilitating symptoms. Prospective comparison of subpectoral and subcutaneous surgical approaches with respect to patient comfort and acceptance and complications may be warranted.

Intramuscular diaphragmatic stimulation for patients with traumatic high cervical injuries and ventilator dependent respiratory failure: A systematic review of safety and effectiveness.

PubMed

Garara, Bhavin; Wood, Alasdair; Marcus, Hani J; Tsang, Kevin; Wilson, Mark H; Khan, Mansoor

2016-03-01

Intramuscular diaphragmatic stimulation using an abdominal laparoscopic approach has been proposed as a safer alternative to traditional phrenic nerve stimulation. It has also been suggested that early implementation of diaphragmatic pacing may prevent diaphragm atrophy and lead to earlier ventilator independence. The aim of this study was therefore to systematically review the safety and effectiveness of intramuscular diaphragmatic stimulators in the treatment of patients with traumatic high cervical injuries resulting in long-term ventilator dependence, with particular emphasis on the affect of timing of insertion of such stimulators. The Cochrane database and PubMed were searched between January 2000 and June 2015. Reference lists of selected papers were also reviewed. The inclusion criteria used to select from the pool of eligible studies were: (1) reported on adult patients with traumatic high cervical injury, who were ventilator-dependant, (2) patients underwent intramuscular diaphragmatic stimulation, and (3) commented on safety and/or effectiveness. 12 articles were included in the review. Reported safety issues post insertion of intramuscular electrodes included pneumothorax, infection, and interaction with pre-existing cardiac pacemaker. Only one procedural failure was reported. The percentage of patients reported as independent of ventilatory support post procedure ranged between 40% and 72.2%. The mean delay of insertion ranged from 40 days to 9.7 years; of note the study with the average shortest delay in insertion reported the greatest percentage of fully weaned patients. Although evidence for intramuscular diaphragmatic stimulation in patients with high cervical injuries and ventilator dependent respiratory failure is currently limited, the technique appears to be safe and effective. Earlier implantation of such devices does not appear to be associated with greater surgical risk, and may be more effective. Further high quality studies are warranted to investigate the impact of delay of insertion on ventilator weaning. Copyright © 2016 Elsevier Ltd. All rights reserved.

Pacemaker and Defibrillator Lead Extraction

MedlinePlus

... a break in the metal wire or surrounding insulation). Sometimes, the broken lead can be abandoned in ... can turn on the sheath's energy source to heat or vaporize scar tissue. This has the effect ...

Surgical outcome of Fontan conversion and arrhythmia surgery: Need a pacemaker?

PubMed

Terada, Takafumi; Sakurai, Hajime; Nonaka, Toshimichi; Sakurai, Takahisa; Sugiura, Junya; Taneichi, Tetsuyoshi; Ohtsuka, Ryohei

2014-07-01

Atrial tachyarrhythmias are frequent complications in the late period after the Fontan procedure, and important risk factors for a poor prognosis. The impact of Fontan conversion and arrhythmia surgery in failed Fontan patients has been described in many reports. We evaluated our experience with Fontan conversion procedures, concomitant arrhythmia surgery, and pacemaker implantation. We reviewed the hospital records of 25 consecutive patients who underwent a Fontan conversion procedure from January 2004 to March 2012. Twenty-four patients had arrhythmia surgery using cryoablation and radiofrequency ablation at the time of conversion. A bilateral atrial maze procedure was performed in 6 patients, right-side maze in 15, and isthmus block in 3. Three patients with a diagnosis of corrected transposition of the great arteries underwent simultaneous pacemaker implantation electively. There was no early death and one late death during a mean follow-up period of 21.2 months. Three tachyarrhythmia recurrences developed, and there were 4 occurrences of sinus bradycardia. Five of these patients required postoperative pacemaker implantation. The mid-term results of Fontan conversion and arrhythmia surgery in our institute were satisfactory. The occurrence of unexpected postoperative pacemaker requirement was high in the patients who underwent a right atrial or bilateral atrial maze procedure. Pacemaker or lead implantation is recommended for patients planned to undergo a right-side or full maze procedure. © The Author(s) 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Retrospective analysis of reasons for failure of DDD pacemaker implantation in patients operated on between 1993 and 2005.

PubMed

Lelakowski, Jacek; Majewski, Jacek; Małecka, Barbara; Bednarek, Jacek; Stypuła, Paweł; Szeglowski, Marcin

2007-01-01

During implantation of a DDD pacemaker the following difficulties may be encountered: venous anomalies (the absence of vessels of adequate calibre or difficulty in subclavian vein puncture), arrhythmias during implantation (episodes of atrial flutter/fibrillation while the atrial leads are being positioned), lack of mechanical stability of the electrode in the heart chamber and inability to achieve an acceptable pacing and sensing threshold during implantation. The purpose of the study was to analyse retrospectively the reasons for DDD pacemaker failure in patients operated on between 1993 and 2005. We reviewed retrospectively all implantation data from 1988 to 2005 to identify patients with primary failure of DDD pacemaker implantation. Further analysis included patients who had received a DDD pacemaker between 1993 and 2005, when this type of pacemaker made up between 9 and 40% of all pacemaker implantations. We implanted 7469 pacemakers, including 1958 (26.2%) dual-chamber pacemakers, in 783 patients with atrioventricular block (AVB), 392 with sick sinus syndrome (SSS), 450 with AVB +/- SSS and 333 with tachy-brady syndrome (TBS). The mean age of the patients was 65.5 +/- 17.3 years. DDD pacing was unsuccessful in 108 (1.4%) patients, including 32 with AVB, 22 with SSS, 16 with SSS +/- AVB and 38 with TBS. The mean age of these patients was 78.5 +/- 19.4 years. The reasons for failed implantation were venous anomalies in 12%, an arrhythmia episode in 27.8%, a high pacing threshold in the atrium in 17.6%, low atrial potential amplitude in 25.9% and lack of mechanical stability of the electrode in 16.7% of patients. The difficulties were encountered in elderly patients (p < 0.01), most frequently in patients with SSS and TBS (71). Between 2004 and 2005 venous anomalies and a high pacing threshold were the main causes of failure. Currently the main difficulties encountered during pacemaker implantation are venous anomalies and a high pacing threshold. Arrhythmia episodes, low atrial potential amplitude and lack of mechanical stability are of minor importance. Elderly patients with sick sinus syndrome and tachy-brady syndrome have the highest failure rate. (Cardiol J 2007; 14: 155-159).

Decreased human circadian pacemaker influence after 100 days in space: a case study

NASA Technical Reports Server (NTRS)

Monk, T. H.; Kennedy, K. S.; Rose, L. R.; Linenger, J. M.

2001-01-01

OBJECTIVE: The objectives of this study were (1) to assess the circadian rhythms and sleep of a healthy, 42-year-old male astronaut experiencing microgravity (weightlessness) for nearly 5 months while living aboard Space Station Mir as it orbited Earth and (2) to determine the effects of prolonged space flight on the endogenous circadian pacemaker, as indicated by oral temperature and subjective alertness rhythms, and their ramifications for sleep, alertness, and performance. METHODS: For three 12- to 14-day blocks of time (spread throughout the mission), oral temperatures were taken and subjective alertness was self-rated five times per day. Sleep diaries and performance tests were also completed daily during each block. RESULTS: Examination of the subject's circadian alertness and oral temperature rhythms suggested that the endogenous circadian pacemaker seemed to function quite well up to 90 days in space. Thereafter (on days 110-122), the influence of the endogenous circadian pacemaker on oral temperature and subjective alertness circadian rhythms was considerably weakened, with consequent disruptions in sleep. CONCLUSIONS: Space missions lasting more than 3 months might result in diminished circadian pacemaker influence in astronauts, leading to eventual sleep problems.

Efficacy and safety of nitroglycerin for preventing venous spasm during contrast-guided axillary vein puncture for pacemaker or defibrillator leads implantation.

PubMed

Duan, Xu; Ling, Feng; Shen, Yun; Yang, Jun; Xu, Hai-ying; Tong, Xiao-shan

2013-04-01

We investigated the efficacy and safety of nitroglycerin for preventing venous spasm during contrast-guided axillary vein puncture for pacemaker or defibrillator leads implantation. A total of 40 consecutive patients referred for contrast-guided axillary vein puncture for pacemaker or defibrillator implantations were included in the study. Patients were randomly assigned to control group and nitroglycerin group. Patients in the nitroglycerin group were given 200 µg (2 mL) nitroglycerin via ipsilateral peripheral vein about 3 min before puncture. The degree of venous spasm was evaluated by the reduction in lumen calibre of the axillary vein after puncture. Mild venous spasm and severe venous spasm were defined as a reduction in lumen calibre of 50-90% and ≥ 90%, respectively. The mean degree of venous spasm of axillary vein was lower in the nitroglycerin group than in the control group (23.0 ± 22.3 vs. 45.5 ± 33.6%, P = 0.018). The incidence of mild or severe venous spasm was lower in the nitroglycerin group than in the control group (3/20 vs. 11/20, P = 0.019). In the nitroglycerin group, the systolic blood pressure had a significant decrease after puncture (129.5 ± 23.7 vs. 143.0 ± 24.1 mmHg, P = 0.003). There was no hypotension and other adverse reaction of nitroglycerin in the nitroglycerin group. Intravenous nitroglycerin is effective and safe for preventing venous spasm during contrast-guided axillary vein puncture for pacemaker or defibrillator leads implantation.

Percutaneously Inject able Fetal Pacemaker: Electrodes, Mechanical Design and Implantation*

PubMed Central

Zhou, Li; Chmait, Ramen; Bar-Cohen, Yaniv; Peck, Raymond A.; Loeb, Gerald E.

2015-01-01

We are developing a self-contained cardiac pacemaker with a small, cylindrical shape (~3×20mm) that permits it to be implanted percutaneously into a fetus to treat complete heart block and consequent hydrops fetalis, which is otherwise fatal. The device uses off-the-shelf components including a rechargeable lithium cell and a highly efficient relaxation oscillator encapsulated in epoxy and glass. A corkscrew electrode made from activated iridium can be screwed into the myocardium, followed by release of the pacemaker and a short, flexible lead entirely within the chest of the fetus to avoid dislodgement from fetal movement. The feasibility of implanting the device percutaneously under ultrasonic imaging guidance was demonstrated in acute adult rabbit experiments. PMID:23367442

[Sport for pacemaker patients].

PubMed

Israel, C W

2012-06-01

Sport activity is an important issue in many patients with a pacemaker either because they performed sport activities before pacemaker implantation to reduce the cardiovascular risk or to improve the course of an underlying cardiovascular disease (e.g. coronary artery disease, heart failure) by sports. Compared to patients with an implantable cardioverter defibrillator (ICD) the risks from underlying cardiovascular disease (e.g. ischemia, heart failure), arrhythmia, lead dysfunction or inappropriate therapy are less important or absent. Sport is contraindicated in dyspnea at rest, acute heart failure, new complex arrhythmia, acute myocarditis and acute myocardial infarction, valvular disease with indications for intervention and surgery and comorbidities which prevent physical activity. Patients with underlying cardiovascular disease (including hypertension) should preferably perform types and levels of physical activity that are aerobic (with dynamic exercise) such as running, swimming, cycling instead of sport with high anaerobic demands and high muscular workload. In heart failure, studies demonstrated advantages of isometric sport that increases the amount of muscle, thereby preventing cardiac cachexia. Sport with a risk of blows to the chest or physical contact (e.g. boxing, rugby, martial arts) should be avoided. Implantation, programming and follow-up should respect specific precautions to allow optimal physical activity with a pacemaker including implantation of bipolar leads on the side contralateral to the dominant hand, individual programming of the upper sensor and tracking rate and regular exercise testing.

Echocardiography in patients with complications related to pacemakers and cardiac defibrillators.

PubMed

Almomani, Ahmed; Siddiqui, Khadija; Ahmad, Masood

2014-03-01

The evolving indications and uses for implantable cardiac devices have led to a significant increase in the number of implanted devices each year. Implantation of endocardial leads for permanent pacemakers and cardiac defibrillators can cause many delayed complications. Complications may be mechanical and related to the interaction of the device leads with the valves and endomyocardium, e.g., perforation, infection, and thrombosis, or due to the electrical pacing of the myocardium and conduction abnormalities, e.g., left ventricular dyssynchrony. Tricuspid regurgitation, another delayed complication in these patients, may be secondary to both mechanical and pacing effects of the device leads. Echocardiography plays an important role in the diagnosis of these device-related complications. Both two-dimensional transthoracic echocardiography and transesophageal echocardiography provide useful diagnostic information. Real time three-dimensional echocardiography is a novel technique that can further enhance the detection of lead-related complications. © 2013, Wiley Periodicals, Inc.

Calsequestrin 2 deletion causes sinoatrial node dysfunction and atrial arrhythmias associated with altered sarcoplasmic reticulum calcium cycling and degenerative fibrosis within the mouse atrial pacemaker complex1

PubMed Central

Glukhov, Alexey V.; Kalyanasundaram, Anuradha; Lou, Qing; Hage, Lori T.; Hansen, Brian J.; Belevych, Andriy E.; Mohler, Peter J.; Knollmann, Björn C.; Periasamy, Muthu; Györke, Sandor; Fedorov, Vadim V.

2015-01-01

Aims Loss-of-function mutations in Calsequestrin 2 (CASQ2) are associated with catecholaminergic polymorphic ventricular tachycardia (CPVT). CPVT patients also exhibit bradycardia and atrial arrhythmias for which the underlying mechanism remains unknown. We aimed to study the sinoatrial node (SAN) dysfunction due to loss of CASQ2. Methods and results In vivo electrocardiogram (ECG) monitoring, in vitro high-resolution optical mapping, confocal imaging of intracellular Ca2+ cycling, and 3D atrial immunohistology were performed in wild-type (WT) and Casq2 null (Casq2−/−) mice. Casq2−/− mice exhibited bradycardia, SAN conduction abnormalities, and beat-to-beat heart rate variability due to enhanced atrial ectopic activity both at baseline and with autonomic stimulation. Loss of CASQ2 increased fibrosis within the pacemaker complex, depressed primary SAN activity, and conduction, but enhanced atrial ectopic activity and atrial fibrillation (AF) associated with macro- and micro-reentry during autonomic stimulation. In SAN myocytes, CASQ2 deficiency induced perturbations in intracellular Ca2+ cycling, including abnormal Ca2+ release, periods of significantly elevated diastolic Ca2+ levels leading to pauses and unstable pacemaker rate. Importantly, Ca2+ cycling dysfunction occurred not only at the SAN cellular level but was also globally manifested as an increased delay between action potential (AP) and Ca2+ transient upstrokes throughout the atrial pacemaker complex. Conclusions Loss of CASQ2 causes abnormal sarcoplasmic reticulum Ca2+ release and selective interstitial fibrosis in the atrial pacemaker complex, which disrupt SAN pacemaking but enhance latent pacemaker activity, create conduction abnormalities and increase susceptibility to AF. These functional and extensive structural alterations could contribute to SAN dysfunction as well as AF in CPVT patients. PMID:24216388

Hemodynamic instability after pulmonary veins isolation in a patient with dual chamber pacemaker

PubMed Central

Kiuchi, Márcio Galindo; Lobato, Guilherme Miglioli; Chen, Shaojie

2017-01-01

Abstract Introduction: The standard treatment of sinus node dysfunction (SND) is the pacemaker implantation, and the ideal methodology for the management of atrial fibrillation (AF) is rhythm control, but this is sometimes very hard to accomplish. For such actions, complete isolation of all pulmonary veins (PVI) is currently widely accepted as the best endpoint. Case Presentation: In this case, we report a female patient, 81 years old, with controlled hypertension, without coronary artery disease, bearer of bilateral knee replacement, and dual chamber pacemaker implanted 1.5 years ago owing to sinus node disease, presenting the following symptoms: presyncope episodes associated with sustained irregular palpitation tachycardia. The evaluation of the pacemaker-recorded episodes of atrial fibrillation, the echocardiogram-presented normal systolic function and measurements, as well as the resting myocardial scintigraphy and with drug use did not demonstrate ischemia and/or fibrosis. The patient was in use of valsartan 320 mg daily, amlodipine 10 mg daily, sotalol hydrochloride 120 mg 2 times daily, and dabigatran 110 mg 2 times daily. At the end of the PVI, the patient presented hemodynamic instability, with a decrease in heart rate to 30 bpm and invasive arterial blood pressure to 60/30 mmHg. The pericardial puncture was quickly carried out with the possibility of cardiac tamponade as the first hypothesis, but no pericardial effusion was found. Next, we detected acute capture loss from the ventricular pacemaker lead, unvarying with high voltage and pulse width, even with stable impedance, sense and keeping the same position visualized by fluoroscopy. And there was soon afterwards induction of sustained ventricular tachycardia degenerating to spontaneous ventricular fibrillation. Electrical cardioversion-defibrillation was performed with 200J, and the sinus rhythm was reestablished, but there was a dead short, and the pacemaker generator was burned and disabled. Conclusions: So, we can speculate that application of atrial radiofrequency for PVI diffused through the tissues, affecting in some way the tip of the ventricular electrode, causing a microlesion in this structure and making it impossible to capture the right ventricle by the pacemaker. As we cannot see it, we can call it of phantom injury of the ventricular lead. PMID:28562571

MRI-conditional pacemakers: current perspectives.

PubMed

Ferreira, António M; Costa, Francisco; Tralhão, António; Marques, Hugo; Cardim, Nuno; Adragão, Pedro

2014-01-01

Use of both magnetic resonance imaging (MRI) and pacing devices has undergone remarkable growth in recent years, and it is estimated that the majority of patients with pacemakers will need an MRI during their lifetime. These investigations will generally be denied due to the potentially dangerous interactions between cardiac devices and the magnetic fields and radio frequency energy used in MRI. Despite the increasing reports of uneventful scanning in selected patients with conventional pacemakers under close surveillance, MRI is still contraindicated in those circumstances and cannot be considered a routine procedure. These limitations prompted a series of modifications in generator and lead engineering, designed to minimize interactions that could compromise device function and patient safety. The resulting MRI-conditional pacemakers were first introduced in 2008 and the clinical experience gathered so far supports their safety in the MRI environment if certain conditions are fulfilled. With this technology, new questions and controversies arise regarding patient selection, clinical impact, and cost-effectiveness. In this review, we discuss the potential risks of MRI in patients with electronic cardiac devices and present updated information regarding the features of MRI-conditional pacemakers and the clinical experience with currently available models. Finally, we provide some guidance on how to scan patients who have these devices and discuss future directions in the field.

Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator.

PubMed

Russo, Robert J; Costa, Heather S; Silva, Patricia D; Anderson, Jeffrey L; Arshad, Aysha; Biederman, Robert W W; Boyle, Noel G; Frabizzio, Jennifer V; Birgersdotter-Green, Ulrika; Higgins, Steven L; Lampert, Rachel; Machado, Christian E; Martin, Edward T; Rivard, Andrew L; Rubenstein, Jason C; Schaerf, Raymond H M; Schwartz, Jennifer D; Shah, Dipan J; Tomassoni, Gery F; Tominaga, Gail T; Tonkin, Allison E; Uretsky, Seth; Wolff, Steven D

2017-02-23

The presence of a cardiovascular implantable electronic device has long been a contraindication for the performance of magnetic resonance imaging (MRI). We established a prospective registry to determine the risks associated with MRI at a magnetic field strength of 1.5 tesla for patients who had a pacemaker or implantable cardioverter-defibrillator (ICD) that was "non-MRI-conditional" (i.e., not approved by the Food and Drug Administration for MRI scanning). Patients in the registry were referred for clinically indicated nonthoracic MRI at a field strength of 1.5 tesla. Devices were interrogated before and after MRI with the use of a standardized protocol and were appropriately reprogrammed before the scanning. The primary end points were death, generator or lead failure, induced arrhythmia, loss of capture, or electrical reset during the scanning. The secondary end points were changes in device settings. MRI was performed in 1000 cases in which patients had a pacemaker and in 500 cases in which patients had an ICD. No deaths, lead failures, losses of capture, or ventricular arrhythmias occurred during MRI. One ICD generator could not be interrogated after MRI and required immediate replacement; the device had not been appropriately programmed per protocol before the MRI. We observed six cases of self-terminating atrial fibrillation or flutter and six cases of partial electrical reset. Changes in lead impedance, pacing threshold, battery voltage, and P-wave and R-wave amplitude exceeded prespecified thresholds in a small number of cases. Repeat MRI was not associated with an increase in adverse events. In this study, device or lead failure did not occur in any patient with a non-MRI-conditional pacemaker or ICD who underwent clinically indicated nonthoracic MRI at 1.5 tesla, was appropriately screened, and had the device reprogrammed in accordance with the prespecified protocol. (Funded by St. Jude Medical and others; MagnaSafe ClinicalTrials.gov number, NCT00907361 .).

Deaths and cardiovascular injuries due to device-assisted implantable cardioverter–defibrillator and pacemaker lead extraction

PubMed Central

Hauser, Robert G.; Katsiyiannis, William T.; Gornick, Charles C.; Almquist, Adrian K.; Kallinen, Linda M.

2010-01-01

Aims An estimated 10 000–15 000 pacemaker and implantable cardioverter–defibrillator (ICD) leads are extracted annually worldwide using specialized tools that disrupt encapsulating fibrous tissue. Additional information is needed regarding the safety of the devices that have been approved for lead extraction. The aim of this study was to determine whether complications due to device-assisted lead extraction might be more hazardous than published data suggest, and whether procedural safety precautions are effective. Methods and results We searched the US Food and Drug Administration's (FDA) Manufacturers and User Defined Experience (MAUDE) database from 1995 to 2008 using the search terms ‘lead extraction and death’ and ‘lead extraction and injury’. Additional product specific searches were performed for the terms ‘death’ and ‘injury’. Between 1995 and 2008, 57 deaths and 48 serious cardiovascular injuries associated with device-assisted lead extraction were reported to the FDA. Owing to underreporting, the FDA database does not contain all adverse events that occurred during this period. Of the 105 events, 27 deaths and 13 injuries occurred in 2007–2008. During these 2 years, 23 deaths were linked with excimer laser or mechanical dilator sheath extractions. The majority of deaths and injuries involved ICD leads, and most were caused by lacerations of the right atrium, superior vena cava, or innominate vein. Overall, 62 patients underwent emergency surgical repair of myocardial perforations and venous lacerations and 35 (56%) survived. Conclusion These findings suggest that device-assisted lead extraction is a high-risk procedure and that serious complications including death may not be mitigated by emergency surgery. However, skilled standby cardiothoracic surgery is essential when performing pacemaker and ICD lead extractions. Although the incidence of these complications is unknown, the results of our study imply that device-assisted lead extractions should be performed by highly qualified physicians and their teams in specialized centres. PMID:19946113

Tropical Pacific variability as a key pacemaker of the global warming staircase

NASA Astrophysics Data System (ADS)

Kosaka, Y.; Xie, S. P.

2016-12-01

Global-mean surface temperature (GMST) has increased since the 19th century with notable interdecadal accelerations and slowdowns, forming the global-warming "staircase". The last step of this staircase is the surface warming slowdown since the late 1990s, for which the transition of the Interdecadal Pacific Oscillation (IPO) from a positive to negative state has been suggested as the leading mechanism. To examine the role of IPO in the entire warming staircase, a long pacemaker experiment is performed with a coupled climate model where tropical Pacific sea surface temperatures are forced to follow the observed evolution since the late 19th century. The pacemaker experiment successfully reproduces the staircase-like global warming remarkably well since 1900. Without the tropical Pacific effect, the same model produces a continual warming from the 1900s to the 1960 followed by rapid warming. The successful reproduction identifies the tropical Pacific decadal variability as a key pacemaker of the GMST staircase. We further propose a method to remove internal variability from observed GMST changes for real-time monitoring of anthropogenic warming.

Permanent Pacemaker Implantation after TAVR – Predictors and Impact on Outcomes

PubMed Central

Sinning, Jan-Malte; Hammerstingl, Christoph; Werner, Nikos; Grube, Eberhard; Nickenig, Georg

2015-01-01

The number of patients undergoing transcatheter aortic valve replacement (TAVR) worldwide is increasing steadily. Atrioventricular conduction disturbances, with or without the need for permanent pacemaker (PPM) implantation, are one of the most common adverse events after TAVR. Among transcatheter heart valves (THV), rates of conduction abnormalities vary from less than 10 % to more than 50 %. Depending on the reported data referred to, historical data showed that up to one-third of the patients required implantation of a PPM following TAVR. Although generally considered as a minor complication, PPM may have a profound impact on prognosis and quality of life after TAVR. Current data support the hypothesis that conduction abnormalities leading to pacemaker dependency result from mechanical compression of the conduction system by the prosthesis stent frame and individual predisposing conduction defects such as right bundle-branch block (RBBB). With several large randomised trials and registry studies having been published recently and second generation THV having been introduced, the debate about predictors for pacemaker implantation and their impact on outcome after TAVR is still ongoing. PMID:29588683

Mechanism underlying impaired cardiac pacemaking rhythm during ischemia: A simulation study

NASA Astrophysics Data System (ADS)

Bai, Xiangyun; Wang, Kuanquan; Yuan, Yongfeng; Li, Qince; Dobrzynski, Halina; Boyett, Mark R.; Hancox, Jules C.; Zhang, Henggui

2017-09-01

Ischemia in the heart impairs function of the cardiac pacemaker, the sinoatrial node (SAN). However, the ionic mechanisms underlying the ischemia-induced dysfunction of the SAN remain elusive. In order to investigate the ionic mechanisms by which ischemia causes SAN dysfunction, action potential models of rabbit SAN and atrial cells were modified to incorporate extant experimental data of ischemia-induced changes to membrane ion channels and intracellular ion homeostasis. The cell models were incorporated into an anatomically detailed 2D model of the intact SAN-atrium. Using the multi-scale models, the functional impact of ischemia-induced electrical alterations on cardiac pacemaking action potentials (APs) and their conduction was investigated. The effects of vagal tone activity on the regulation of cardiac pacemaker activity in control and ischemic conditions were also investigated. The simulation results showed that at the cellular level ischemia slowed the SAN pacemaking rate, which was mainly attributable to the altered Na+-Ca2+ exchange current and the ATP-sensitive potassium current. In the 2D SAN-atrium tissue model, ischemia slowed down both the pacemaking rate and the conduction velocity of APs into the surrounding atrial tissue. Simulated vagal nerve activity, including the actions of acetylcholine in the model, amplified the effects of ischemia, leading to possible SAN arrest and/or conduction exit block, which are major features of the sick sinus syndrome. In conclusion, this study provides novel insights into understanding the mechanisms by which ischemia alters SAN function, identifying specific conductances as contributors to bradycardia and conduction block.

Design and Testing of a Percutaneously Implantable Fetal Pacemaker

PubMed Central

Loeb, Gerald E.; Zhou, Li; Zheng, Kaihui; Nicholson, Adriana; Peck, Raymond A.; Krishnan, Anjana; Silka, Michael; Pruetz, Jay; Chmait, Ramen; Bar-Cohen, Yaniv

2012-01-01

We are developing a cardiac pacemaker with a small, cylindrical shape that permits percutaneous implantation into a fetus to treat complete heart block and consequent hydrops fetalis, which can otherwise be fatal. The device uses off-the-shelf components including a rechargeable lithium cell and a highly efficient relaxation oscillator encapsulated in epoxy and glass. A corkscrew electrode made from activated iridium can be screwed into the myocardium, followed by release of the pacemaker and a short, flexible lead entirely within the chest of the fetus to avoid dislodgement from fetal movement. Acute tests in adult rabbits demonstrated the range of electrical parameters required for successful pacing and the feasibility of successfully implanting the device percutaneously under ultrasonic imaging guidance. The lithium cell can be recharged inductively as needed, as indicated by a small decline in the pulsing rate. PMID:22855119

Clinical safety of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions.

PubMed

Bailey, William M; Mazur, Alexander; McCotter, Craig; Woodard, Pamela K; Rosenthal, Lawrence; Johnson, Whitney; Mela, Theofanie

2016-02-01

Permanent cardiac pacemakers have historically been considered a contraindication to magnetic resonance imaging (MRI). The purpose of the ProMRI Phase B Study, a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI pacemaker system in patients undergoing thoracic spine and cardiac MRI. The ProMRI Phase B study enrolled 245 patients with stable baseline pacing indices implanted with an Entovis pacemaker (DR-T or SR-T) and Setrox 53-cm and/or 60-cm lead(s). Device interrogation was performed at enrollment, pre- and post-MRI scan, and 1 and 3 months post-MRI. End-points were (1) freedom from MRI- and pacing system-related serious adverse device effects through 1 month post-MRI; (2) freedom from atrial and ventricular MRI-induced pacing threshold increase (>0.5 V); and (3) freedom from P- and R-wave amplitude attenuation (<50%), or P wave <1.5 mV, or R wave <5.0 mV at 1 month post-MRI. In total, 216 patients completed the MRI and 1-month post-MRI follow-up. One adverse event possibly related to the implanted system and the MRI procedure occurred, resulting in a serious adverse device effect-free rate of 99.6% (220/221; P < .0001. Freedom from atrial and ventricular pacing threshold increase was 100% (194/194, P < .001) and 100% (206/206, P < .001) respectively. Freedom from P- and R-wave amplitude attenuation was 98.2% (167/170, P < .001) and 100% (188/188, P < .001) respectively. The results of the ProMRI Phase B study demonstrate the clinical safety and efficacy of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac MRI conditions. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Pacemaker leads: performance and progress.

PubMed

de Voogt, W G

1999-03-11

Pacing leads remain the "weaker link" of the permanent pacing system. Lead failure has been an issue since the beginning of implantable pacemaker therapy. Modern electronics have brought about considerable progress in pacing technology, but lead design has been slower to evolve and problems persist. IS-1 standardization must be considered a significant advance, but some issues regarding IS-1 standardization persist and have been the cause of some compatibility problems. With respect to lead insulation, silicone has proved to offer total reliability for > 30 years. In the search for better handling characteristics, polyurethane 80A was employed for bipolar leads, but it failed to demonstrate satisfactory insulating properties. New insulation materials, such as ethylene-fluoro-ethylene (ETFE), and coated wire technology look promising, having shown 99.32% survival at 5-year follow-up. Reliability is the main objective in lead design, but leads should provide low battery consumption as well. Low coil resistance, with high electrode impedance in steroid-eluting leads, is the standard at present. Low polarization is a desirable property for 2 main reasons: (1) in conjunction with low-threshold leads, it decreases battery consumption; and (2) it allows capture detection and, therefore, safer pacing at low battery consumption. Lead tip design as well as pacing pulse configuration can influence polarization.

Cardiobacterium hominis and Cardiobacterium valvarum: Two Case Stories with Infective Episodes in Pacemaker Treated Patients.

PubMed

Bonavent, Tina Bennett; Nielsen, Xiaohui Chen; Kristensen, Kjeld Skødebjerg; Ihlemann, Nikolaj; Moser, Claus; Christensen, Jens Jørgen

2016-01-01

Cardiobacterium hominis and Cardiobacterium valvarum are well known, though rare, etiologic agents of infective endocarditis. Cardiac devices are increasingly implanted. Two cases of infective episodes in pacemaker (PM) treated patients with respectively C. hominis and C. valvarum are presented. In one case blood-culture bottles yielded growth of C. hominis at two episodes with two years apart. At the second episode a vegetation was recognized at the PM lead and the PM device and lead was removed. In the C. valvarum case, echocardiography revealed a bicuspid aortic valve with severe regurgitation and a more than 1 cm sized vegetation. The cases illustrate the diversity in disease severity by Cardiobacterium species. Careful follow up has to be performed in order not to overlook a relatively silent relapsing infection.

Transaortic TAVI Is a Valid Alternative to Transapical Approach.

PubMed

O' Sullivan, Katie E; Hurley, Eoghan T; Segurado, Ricardo; Sugrue, Declan; Hurley, John P

2015-05-01

Transcatheter aortic valve implantation (TAVI) can be performed via a number of different anatomical approaches based on patient characteristics and operator choice. The aim of this study was to compare procedural outcomes between transaortic (TAo) and transapical (TA) approaches in an effort to establish whether any differences exist. A systematic review and meta-analysis of the current literature reporting outcomes for patients undergoing TAo and TA TAVI was performed to compare outcomes using each vascular approach to valve deployment. A total of 10 studies and 1736 patients were included. A total of 193 patients underwent TAo and 1543 TA TAVI. No significant difference in 30-day mortality was identified (TAo 9.4, TA 10.4 p = 0.7). There were no significant differences identified between TAo and TA TAVI in procedural success rate (96.3% vs. 93.7% p = 0.3), stroke and transient ischemic attack (TIA) incidence (1.8% vs. 2.3% p = 0.7), major bleed (5.8% vs. 5.5% p = 0.97) or pacemaker insertion rates (6.1% vs. 7.4% p = 0.56). In addition, the incidence of clinically significant paravalvular regurgitation (PVR) was the same between groups (6.7% vs. 11% p = 0.43). Comparison of TAo and TA approaches revealed equivalent outcomes in 30-day mortality, procedural success, major bleeding, stroke/TIA incidence, pacemaker insertion rates and paravalvular leak. Heart teams should be familiar with the use of both TA and TAo access and tailor their selection on a case-to-case basis. © 2015 Wiley Periodicals, Inc.

Entraining the topology and the dynamics of a network of phase oscillators

NASA Astrophysics Data System (ADS)

Sendiña-Nadal, I.; Leyva, I.; Buldú, J. M.; Almendral, J. A.; Boccaletti, S.

2009-04-01

We show that the topology and dynamics of a network of unsynchronized Kuramoto oscillators can be simultaneously controlled by means of a forcing mechanism which yields a phase locking of the oscillators to that of an external pacemaker in connection with the reshaping of the network’s degree distribution. The entrainment mechanism is based on the addition, at regular time intervals, of unidirectional links from oscillators that follow the dynamics of a pacemaker to oscillators in the pristine graph whose phases hold a prescribed phase relationship. Such a dynamically based rule in the attachment process leads to the emergence of a power-law shape in the final degree distribution of the graph whenever the network is entrained to the dynamics of the pacemaker. We show that the arousal of a scale-free distribution in connection with the success of the entrainment process is a robust feature, characterizing different networks’ initial configurations and parameters.

Implantable cardiac arrhythmia devices--part I: pacemakers.

PubMed

Kusumoto, Fred M; Goldschlager, Nora

2006-05-01

Implantable cardiac devices have become firmly entrenched as important therapeutic tools for a variety of cardiac conditions. The first part of this two-part review will discuss the contemporary use and follow-up of pacemakers, while the second part will address the use of implantable cardioverter defibrillators and implantable loop recorders. Pacemakers are the only available treatment for symptomatic bradycardia not due to reversible causes. Large randomized studies have demonstrated a small but statistically significant reduction in atrial fibrillation associated with pacing modes that maintain atrioventricular synchrony. In contrast, pacing mode appears to have a less dramatic effect in patients with atrioventricular block. Cardiac resynchronization with specialized left ventricular leads has been shown to reduce symptoms and improve survival in patients with symptomatic heart failure, systolic dysfunction, and widened QRS complexes. For all patients, careful follow-up is necessary to ensure optimal therapeutic benefit of pacing systems.

Safety of the Wearable Cardioverter Defibrillator (WCD) in Patients with Implanted Pacemakers.

PubMed

Schmitt, Joern; Abaci, Guezine; Johnson, Victoria; Erkapic, Damir; Gemein, Christopher; Chasan, Ritvan; Weipert, Kay; Hamm, Christian W; Klein, Helmut U

2017-03-01

The wearable cardioverter defibrillator (WCD) is an important approach for better risk stratification, applied to patients considered to be at high risk of sudden arrhythmic death. Patients with implanted pacemakers may also become candidates for use of the WCD. However, there is a potential risk that pacemaker signals may mislead the WCD detection algorithm and cause inappropriate WCD shock delivery. The aim of the study was to test the impact of different types of pacing, various right ventricular (RV) lead positions, and pacing modes for potential misleading of the WCD detection algorithm. Sixty patients with implanted pacemakers received the WCD for a short time and each pacing mode (AAI, VVI, and DDD) was tested for at least 30 seconds in unipolar and bipolar pacing configuration. In case of triggering the WCD detection algorithm and starting the sequence of arrhythmia alarms, shock delivery was prevented by pushing of the response buttons. In six of 60 patients (10%), continuous unipolar pacing in DDD mode triggered the WCD detection algorithm. In no patient, triggering occurred with bipolar DDD pacing, unipolar and bipolar AAI, and VVI pacing. Triggering was independent of pacing amplitude, RV pacing lead position, and pulse generator implantation site. Unipolar DDD pacing bears a high risk of false triggering of the WCD detection algorithm. Other types of unipolar pacing and all bipolar pacing modes do not seem to mislead the WCD detection algorithm. Therefore, patients with no reprogrammable unipolar DDD pacing should not become candidates for the WCD. © 2016 Wiley Periodicals, Inc.

Beam Profile Disturbances from Implantable Pacemakers or Implantable Cardioverter-Defibrillator Interactions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gossman, Michael S., E-mail: mgossman@tsrcc.com; Comprehensive Heart and Vascular Associates, Heart and Vascular Center, Ashland, KY; Medtronic, Inc., External Research Program, Mounds View, MN

2011-01-01

The medical community is advocating for progressive improvement in the design of implantable cardioverter-defibrillators and implantable pacemakers to accommodate elevations in dose limitation criteria. With advancement already made for magnetic resonance imaging compatibility in some, a greater need is present to inform the radiation oncologist and medical physicist regarding treatment planning beam profile changes when such devices are in the field of a therapeutic radiation beam. Treatment plan modeling was conducted to simulate effects induced by Medtronic, Inc.-manufactured devices on therapeutic radiation beams. As a continuation of grant-supported research, we show that radial and transverse open beam profiles of amore » medical accelerator were altered when compared with profiles resulting when implantable pacemakers and cardioverter-defibrillators are placed directly in the beam. Results are markedly different between the 2 devices in the axial plane and the sagittal planes. Vast differences are also presented for the therapeutic beams at 6-MV and 18-MV x-ray energies. Maximum changes in percentage depth dose are observed for the implantable cardioverter-defibrillator as 9.3% at 6 MV and 10.1% at 18 MV, with worst distance to agreement of isodose lines at 2.3 cm and 1.3 cm, respectively. For the implantable pacemaker, the maximum changes in percentage depth dose were observed as 10.7% at 6 MV and 6.9% at 18 MV, with worst distance to agreement of isodose lines at 2.5 cm and 1.9 cm, respectively. No differences were discernible for the defibrillation leads and the pacing lead.« less

Improving pacemaker therapy in congenital heart disease: contractility and resynchronization.

PubMed

Karpawich, Peter P

2015-01-01

Designed as effective therapy for patients with symptomatic bradycardia, implantable cardiac pacemakers initially served to improve symptoms and survival. With initial applications to the elderly and those with severe myocardial disease, extended longevity was not a major concern. However, with design technology advances in leads and generators since the 1980s, pacemaker therapy is now readily applicable to all age patients, including children with congenital heart defects. As a result, emphasis and clinical interests have advanced beyond simply quantity to quality of life. Adverse cardiac effects of pacing from right ventricular apical or epicardial sites with resultant left bundle branch QRS configurations have been recognized. As a result, and with the introduction of newer catheter-delivered pacing leads, more recent studies have focused on alternative or select pacing sites such as septal, outflow tract, and para-bundle of His. This is especially important in dealing with pacemaker therapy among younger patients and those with congenital heart disease, with expected decades of artificial cardiac stimulation, in which adverse myocellular changes secondary to pacing itself have been reported. As a correlate to these alternate or select pacing sites, applications of left ventricular pacing, either via the coronary sinus, intraseptal or epicardial, alone or in combination with right ventricular pacing, have gained interest for patients with heart failure. Although cardiac resynchronization pacing has, to date, had limited clinical applications among patients with congenital heart disease, the few published reports do indicate potential benefits as a bridge to cardiac transplant. Copyright © 2015 Elsevier Inc. All rights reserved.

Modern Pacemaker and Implantable Cardioverter/Defibrillator Systems Can Be Magnetic Resonance Imaging Safe

PubMed Central

Roguin, Ariel; Zviman, Menekhem M.; Meininger, Glenn R.; Rodrigues, E. Rene; Dickfeld, Timm M.; Bluemke, David A.; Lardo, Albert; Berger, Ronald D.; Calkins, Hugh; Halperin, Henry R.

2011-01-01

Background MRI has unparalleled soft-tissue imaging capabilities. The presence of devices such as pacemakers and implantable cardioverter/defibrillators (ICDs), however, is historically considered a contraindication to MRI. These devices are now smaller, with less magnetic material and improved electromagnetic interference protection. Our aim was to determine whether these modern systems can be used in an MR environment. Methods and Results We tested in vitro and in vivo lead heating, device function, force acting on the device, and image distortion at 1.5 T. Clinical MR protocols and in vivo measurements yielded temperature changes <0.5°C. Older (manufactured before 2000) ICDs were damaged by the MR scans. Newer ICD systems and most pacemakers, however, were not. The maximal force acting on newer devices was <100 g. Modern (manufactured after 2000) ICD systems were implanted in dogs (n=18), and after 4 weeks, 3- to 4-hour MR scans were performed (n=15). No device dysfunction occurred. The images were of high quality with distortion dependent on the scan sequence and plane. Pacing threshold and intracardiac electrogram amplitude were unchanged over the 8 weeks, except in 1 animal that, after MRI, had a transient (<12 hours) capture failure. Pathological data of the scanned animals revealed very limited necrosis or fibrosis at the tip of the lead area, which was not different from controls (n=3) not subjected to MRI. Conclusions These data suggest that certain modern pacemaker and ICD systems may indeed be MRI safe. This may have major clinical implications for current imaging practices. PMID:15277324

Lead-related complications after DDD pacemaker implantation.

PubMed

Dębski, Maciej; Ulman, Mateusz; Ząbek, Andrzej; Boczar, Krzysztof; Haberka, Kazimierz; Kuniewicz, Marcin; Lelakowski, Jacek; Małecka, Barbara

2018-04-10

Pacing leads remain the weakest link in pacemaker systems despite advances in manufacturing technology. To assess the long-term pacing lead performance in an unselected real-life cohort following primary DDD pacing system implantation. A single-centre retrospective analysis of patients who underwent DDD pacing system implantation between October 1984 and December 2014 and were followed up until August 2016 was conducted. The inclusion criterion was at least one follow-up visit following post-implant discharge. The performance of each atrial and ventricular lead implanted was evaluated during the follow-up period, and the incidence of and predictive factors for lead dislodgement and failure were analysed. The data of 3771 patients and 24431.8 patient-years of follow-up were analysed. The mean follow-up of patients was 77.7 ± 61.8 months. During the study period, 7887 transvenous atrial and right ventricular pacing leads were implanted. Lead dislodgement occurred in 94 (1.2%) leads [92 (2.4%) patients], perforation in 11 (0.1%) leads [10 (0.3%) patients] and lead failure in 329 (4.2%) leads [275 (7.3%) patients]. Atrial lead position was a predictive factor for lead dislodgement, while age at implantation, polyurethane 80A insulation, subclavian vein access, unipolar lead construction and lead manufacturer were multivariate predictors of lead failure. Leads with polyurethane 80A insulation, unipolar construction and implantation via subclavian vein puncture exhibited the worst long-term performance.

Financial audit of antitachycardia pacing for the control of recurrent supraventricular tachycardia.

PubMed Central

Griffith, M J; Bexton, R S; McComb, J M

1993-01-01

OBJECTIVE--To assess the financial implications of antitachycardia pacing in patients with frequent supraventricular tachycardia. PATIENTS--Intertach pacemakers were implanted in 25 patients (mean age 47 years, five men): 22 had atrioventricular nodal reentry tachycardia. The patients had failed a mean of 4.9 (range zero to eight) drugs and had been admitted to hospital 3.7 (zero to 31) times over a symptomatic period of 13.9 years (two months to 54 years). RESULTS--The mean admission time for implantation was 2.8 (two to seven) days. One patient with Wolff-Parkinson-White syndrome subsequently underwent surgery. Infection occurred in two patients, and pain over the pacemaker required its resiting in two. Two patients have had one admission each for tachycardia. Six patients remain on anti-arrhythmic drugs. Costs were calculated including value added tax, capital charges, and allocated overheads. The cost a year before pacing was 1174 pounds including drug costs, clinic visits, and hospital admissions. The mean cost of pacemaker implantation was 3364.22 pounds, including the pacemaker and lead, admission and procedure, readmissions and first pacing check. Subsequent annual follow up cost was 73.72 pounds including annual clinic visits and drug costs. The cost of pacing is 4241 pounds whereas medical management costs 7044 pounds assuming pacemaker life of six years: with a 10 year life the cost is 4537 pounds compared with 11,740 pounds: with a 12 year life the cost is 4685 pounds compared with 14,088 pounds. CONCLUSION--The excess cost of implantation of an antitachycardia pacemaker is minimal in patients with frequent supraventricular tachycardia despite drug treatment and is justified by excellent control of symptoms and reduction of drug use and hospital admissions. PMID:8461232

Financial audit of antitachycardia pacing for the control of recurrent supraventricular tachycardia.

PubMed

Griffith, M J; Bexton, R S; McComb, J M

1993-03-01

To assess the financial implications of antitachycardia pacing in patients with frequent supraventricular tachycardia. Intertach pacemakers were implanted in 25 patients (mean age 47 years, five men): 22 had atrioventricular nodal reentry tachycardia. The patients had failed a mean of 4.9 (range zero to eight) drugs and had been admitted to hospital 3.7 (zero to 31) times over a symptomatic period of 13.9 years (two months to 54 years). The mean admission time for implantation was 2.8 (two to seven) days. One patient with Wolff-Parkinson-White syndrome subsequently underwent surgery. Infection occurred in two patients, and pain over the pacemaker required its resiting in two. Two patients have had one admission each for tachycardia. Six patients remain on anti-arrhythmic drugs. Costs were calculated including value added tax, capital charges, and allocated overheads. The cost a year before pacing was 1174 pounds including drug costs, clinic visits, and hospital admissions. The mean cost of pacemaker implantation was 3364.22 pounds, including the pacemaker and lead, admission and procedure, readmissions and first pacing check. Subsequent annual follow up cost was 73.72 pounds including annual clinic visits and drug costs. The cost of pacing is 4241 pounds whereas medical management costs 7044 pounds assuming pacemaker life of six years: with a 10 year life the cost is 4537 pounds compared with 11,740 pounds: with a 12 year life the cost is 4685 pounds compared with 14,088 pounds. The excess cost of implantation of an antitachycardia pacemaker is minimal in patients with frequent supraventricular tachycardia despite drug treatment and is justified by excellent control of symptoms and reduction of drug use and hospital admissions.

Transfemoral access when superior venous approach is not feasible equals overall success of permanent pacemaker implantation. Ten-year series.

PubMed

García Guerrero, Juan J; Fernández de la Concha Castañeda, Joaquín; Doblado Calatrava, Manuel; Redondo Méndez, Ángel; Lázaro Medrano, Manuel; Merchán Herrera, Antonio

2017-06-01

When permanent pacemaker implantation is not possible or advisable via superior venous access (i.e., axillary or subclavian veins), safe and feasible surgical alternatives are required. The femoral approach is relatively unknown and seldom studied. This single-center study analyzed 10-year outcomes of a femoral implantation approach. Data about the implantation procedure (indication, approach, lead and pacemaker models, complications), patient characteristics (age, sex, medications, comorbidities), and follow-up were analyzed for all permanent pacemaker implantations using the femoral approach between June 2001 and June 2011. A permanent pacemaker was implanted with the femoral approach in 50 patients (mean age, 76 years [range: 45-96], 31 [61%] men). The most frequent indication was atrioventricular block, associated with sinus rhythm in 30 patients and with atrial fibrillation in eight patients. Overall, 20 patients (40%) were treated with oral anticoagulants postimplantation. Mean implantation time was 64 minutes (range: 20-210) and mean fluoroscopy time was 6.7 minutes (range: 0.2-50). Minimum follow-up window was 1 year (June 2012), with a mean of 50 months [range: 1-113]). No deaths, septic episodes, or severe complications were associated with the procedure, acute or long-term. Follow-up data were available for 46 patients, of who 21 (46%) died during follow-up (mean age, 87 years [range: 73-101]). No cause of death was associated with the femoral technique. Permanent pacemaker implantation through femoral access is not difficult for an experienced implant surgeon. Outcomes were comparable to systems implanted by superior venous approach, and no severe complications were observed at 10-year follow-up. © 2017 Wiley Periodicals, Inc.

Safety evaluation of a leadless transcatheter pacemaker for magnetic resonance imaging use.

PubMed

Soejima, Kyoko; Edmonson, Jonathan; Ellingson, Michael L; Herberg, Ben; Wiklund, Craig; Zhao, Jing

2016-10-01

Increased magnetic resonance imaging (MRI) adoption and demand are driving the need for device patients to have safe access to MRI. The aim of this study was to address the interactions of MRI with the Micra transcatheter pacemaker system. A strategy was developed to evaluate potential MRI risks including device heating, unintended cardiac stimulation, force, torque, vibration, and device malfunction. Assessment of MRI-induced device heating was conducted using a phantom containing gelled saline, and Monte Carlo simulations incorporating these results were conducted to simulate numerous combinations of human body models, position locations in the MRI scanner bore, and a variety of coil designs. Lastly, a patient with a Micra pacemaker who underwent a clinically indicated MRI scan is presented. Compared to traditional MRI conditional pacemakers, the overall risk with Micra was greatly reduced because of the small size of the device and the absence of a lead. The modeling results predicted that the nonperfused temperature rise of the device would be less than 0.4°C at 1.5 T and 0.5°C at 3 T and that the risk of device heating with multiple device implants was not increased as compared with a single device. The clinical case study revealed no MRI-related complications. The MRI safety assessment tests conducted for the Micra pacemaker demonstrate that patients with a single device or multiple devices can safely undergo MRI scans in both 1.5- and 3-T MRI scanners. No MRI-related complications were observed in a patient implanted with a Micra pacemaker undergoing a clinically indicated scan. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Tachycardia-bradycardia syndrome: Electrophysiological mechanisms and future therapeutic approaches (Review)

PubMed Central

Tse, Gary; Liu, Tong; Li, Ka Hou Christien; Laxton, Victoria; Wong, Andy On-Tik; Chan, Yin Wah Fiona; Keung, Wendy; Chan, Camie W.Y.; Li, Ronald A.

2017-01-01

Sick sinus syndrome (SSS) encompasses a group of disorders whereby the heart is unable to perform its pacemaker function, due to genetic and acquired causes. Tachycardia-bradycardia syndrome (TBS) is a complication of SSS characterized by alternating tachycardia and bradycardia. Techniques such as genetic screening and molecular diagnostics together with the use of pre-clinical models have elucidated the electrophysiological mechanisms of this condition. Dysfunction of ion channels responsible for initiation or conduction of cardiac action potentials may underlie both bradycardia and tachycardia; bradycardia can also increase the risk of tachycardia, and vice versa. The mainstay treatment option for SSS is pacemaker implantation, an effective approach, but has disadvantages such as infection, limited battery life, dislodgement of leads and catheters to be permanently implanted in situ. Alternatives to electronic pacemakers are gene-based bio-artificial sinoatrial node and cell-based bio-artificial pacemakers, which are promising techniques whose long-term safety and efficacy need to be established. The aim of this article is to review the different ion channels involved in TBS, examine the three-way relationship between ion channel dysfunction, tachycardia and bradycardia in TBS and to consider its current and future therapies. PMID:28204831

Tachycardia-bradycardia syndrome: Electrophysiological mechanisms and future therapeutic approaches (Review).

PubMed

Tse, Gary; Liu, Tong; Li, Ka Hou Christien; Laxton, Victoria; Wong, Andy On-Tik; Chan, Yin Wah Fiona; Keung, Wendy; Chan, Camie W Y; Li, Ronald A

2017-03-01

Sick sinus syndrome (SSS) encompasses a group of disorders whereby the heart is unable to perform its pacemaker function, due to genetic and acquired causes. Tachycardia‑bradycardia syndrome (TBS) is a complication of SSS characterized by alternating tachycardia and bradycardia. Techniques such as genetic screening and molecular diagnostics together with the use of pre-clinical models have elucidated the electrophysiological mechanisms of this condition. Dysfunction of ion channels responsible for initiation or conduction of cardiac action potentials may underlie both bradycardia and tachycardia; bradycardia can also increase the risk of tachycardia, and vice versa. The mainstay treatment option for SSS is pacemaker implantation, an effective approach, but has disadvantages such as infection, limited battery life, dislodgement of leads and catheters to be permanently implanted in situ. Alternatives to electronic pacemakers are gene‑based bio‑artificial sinoatrial node and cell‑based bio‑artificial pacemakers, which are promising techniques whose long-term safety and efficacy need to be established. The aim of this article is to review the different ion channels involved in TBS, examine the three‑way relationship between ion channel dysfunction, tachycardia and bradycardia in TBS and to consider its current and future therapies.

Is there a right place to pace the right ventricle? Evaluation of apical and septal positions in a pacemaker population: study protocol for a prospective intervention-control trial.

PubMed

Muto, Carmine; Calvi, Valeria; Botto, Giovanni Luca; Pecora, Domenico; Ciaramitaro, Gianfranco; Valsecchi, Sergio; Malacrida, Maurizio; Maglia, Giampiero

2014-11-01

The main objective of research in pacemaker therapy has been to provide the best physiologic way to pace the heart. Despite the good results provided by right ventricular pacing minimization and by biventricular pacing in specific subsets of heart failure patients, these options present many limitations for standard pacemaker recipients. In these patients, pacing the right ventricle at alternative sites could result in a lower degree of left intraventricular dyssynchrony. Despite the lack of strong evidence and the difficulty in placing and accurately classifying the final lead position, pacing at alternative right ventricular sites seems to have become a standard procedure at many implanting centers. The RIGHT PACE study is a multi-center, prospective, single-blind, double-arm, intervention-control trial comparing right ventricular pacing from the apex and from the septal site in terms of left intraventricular dyssynchrony. A total of 408 patients with indications for cardiac pacing but without indications for ICD and/or CRT will be enrolled. Investigators will be divided on the basis of their prior experience of selective site pacing lead implantation and patients will be treated according to the clinical practice of the centers. After device implantation, they will be followed up for 24 months through evaluation of clinical, echocardiographic and safety/system-performance variables. This study might provide important information about the impact of the right ventricular pacing on the left ventricular dyssynchrony, and about acute and chronic responses to selective site pacing, as adopted in current clinical practice. This trial is registered at ClinicalTrials.gov (ID:NCT01647490). Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of apical and alternative position. ClinicalTrials.gov: NCT01647490. Copyright © 2014 Elsevier Inc. All rights reserved.

HCN4-Overexpressing Mouse Embryonic Stem Cell-Derived Cardiomyocytes Generate a New Rapid Rhythm in Rats with Bradycardia.

PubMed

Saito, Yukihiro; Nakamura, Kazufumi; Yoshida, Masashi; Sugiyama, Hiroki; Takano, Makoto; Nagase, Satoshi; Morita, Hiroshi; Kusano, Kengo F; Ito, Hiroshi

2018-05-30

A biological pacemaker is expected to solve the persisting problems of an artificial cardiac pacemaker including short battery life, lead breaks, infection, and electromagnetic interference. We previously reported HCN4 overexpression enhances pacemaking ability of mouse embryonic stem cell-derived cardiomyocytes (mESC-CMs) in vitro. However, the effect of these cells on bradycardia in vivo has remained unclear. Therefore, we transplanted HCN4-overexpressing mESC-CMs into bradycardia model animals and investigated whether they could function as a biological pacemaker. The rabbit Hcn4 gene was transfected into mouse embryonic stem cells and induced HCN4-overexpressing mESC-CMs. Non-cardiomyocytes were removed under serum/glucose-free and lactate-supplemented conditions. Cardiac balls containing 5 × 10 3 mESC-CMs were made by using the hanging drop method. One hundred cardiac balls were injected into the left ventricular free wall of complete atrioventricular block (CAVB) model rats. Heart beats were evaluated using an implantable telemetry system 7 to 30 days after cell transplantation. The result showed that ectopic ventricular beats that were faster than the intrinsic escape rhythm were often observed in CAVB model rats transplanted with HCN4-overexpressing mESC-CMs. On the other hand, the rats transplanted with non-overexpressing mESC-CMs showed sporadic single premature ventricular contraction but not sustained ectopic ventricular rhythms. These results indicated that HCN4-overexpressing mESC-CMs produce rapid ectopic ventricular rhythms as a biological pacemaker.

Ambulatory Holter monitoring in asymptomatic patients with DDD pacemakers - do we need ACC/AHA Guidelines revision?

PubMed

Chudzik, Michal; Klimczak, Artur; Wranicz, Jerzy Krzysztof

2013-10-31

We sought to determine the usefulness of ambulatory 24-hour Holter monitoring in detecting asymptomatic pacemaker (PM) malfunction episodes in patients with dual-chamber pacemakers whose pacing and sensing parameters were proper, as seen in routine post-implantation follow-ups. Ambulatory 24-hour Holter recordings (HM) were performed in 100 patients with DDD pacemakers 1 day after the implantation. Only asymptomatic patients with proper pacing and sensing parameters (assessed on PM telemetry on the first day post-implantation) were enrolled in the study. The following parameters were assessed: failure to pace, failure to sense (both oversensing and undersensing episodes) as well as the percentage of all PM disturbances. Despite proper sensing and pacing parameters, HM revealed PM disturbances in 23 patients out of 100 (23%). Atrial undersensing episodes were found in 12 patients (p < 0.005) with totally 963 episodes and failure to capture in 1 patient (1%). T wave oversensing was the most common ventricular channel disorder (1316 episodes in 9 patients, p < 0.0005). Malfunction episodes occurred sporadically, leading to pauses of up to 1.6 s or temporary bradycardia, which were, nevertheless, not accompanied by clinical symptoms. No ventricular pacing disturbances were found. Asymptomatic pacemaker dysfunction may be observed in nearly 25% of patients with proper DDD parameters after implantation. Thus, ambulatory HM during the early post-implantation period may be a useful tool to detect the need to reprogram PM parameters.

Cardiac Resynchronization Therapy and phase resetting of the sinoatrial node: A conjecture

NASA Astrophysics Data System (ADS)

Cantini, Federico; Varanini, Maurizio; Macerata, Alberto; Piacenti, Marcello; Morales, Maria-Aurora; Balocchi, Rita

2007-03-01

Congestive heart failure is a severe chronic disease often associated with disorders that alter the mechanisms of excitation-contraction coupling that may result in an asynchronous left ventricular motion which may further impair the ability of the failing heart to eject blood. In recent years a therapeutic approach to resynchronize the ventricles (cardiac resynchronization therapy, CRT) has been performed through the use of a pacemaker device able to provide atrial-based biventricular stimulation. Atrial lead senses the spontaneous occurrence of cells depolarization and sends the information to the generator which, in turn, after a settled delay [atrioventricular (AV) delay], sends electrical impulses to both ventricles to stimulate their synchronous contraction. Recent studies performed on heart rate behavior of chronically implanted patients at different epochs after implantation have shown that CRT can lead to sustained overall improvement of heart function with a reduction in morbidity and mortality. At this moment, however, there are no studies about CRT effects on spontaneous heart activity of chronically implanted patients. We performed an experimental study in which the electrocardiographic signal of five subjects under chronic CRT was recorded during the activity of the pacemaker programmed at different AV delays and under spontaneous cardiac activity after pacemaker deactivation. The different behavior of heart rate variability during pacemaker activity and after pacemaker deactivation suggested the hypothesis of a phase resetting mechanism induced by the pacemaker stimulus on the sinoatrial (SA) node, a phenomenon already known in literature for aggregate of cardiac cells, but still unexplored in vivo. The constraints imposed by the nature of our study (in vivo tests) made it impossible to plan an experiment to prove our hypothesis directly. We therefore considered the best attainable result would be to prove the accordance of our data to the conjecture through the use of models and physical considerations. We first used the data of literature on far-field effects of cardiac defibrillators to prove that the pacemaker impulses delivered to the two ventricles were able to induce modifications in membrane voltage at the level of the SA node. To simulate a phase resetting mechanism of the SA node, we used a Van der Pol modified model to allow the possibility of changing the refractory period and the firing frequency of the cells separately. With appropriate parameters of the model we reproduced phase response curves that can account for our experimental data. Furthermore, the simulated curves closely resemble the functional form proposed in literature for perturbed aggregate of cardiac cells. Despite the small sample of subjects investigated and the limited number of ECG recordings at different AV delays, we think we have proved the plausibility of the proposed conjecture.

Spanish Pacemaker Registry. Thirteenth Official Report of the Spanish Society of Cardiology Working Group on Cardiac Pacing (2015).

PubMed

Pombo Jiménez, Marta; Cano Pérez, Óscar; Fidalgo Andrés, María Luisa; Lorente Carreño, Diego; Coma Samartín, Raúl

2016-12-01

We describe the results of the analysis of the devices implanted and conveyed to the Spanish Pacemaker Registry in 2015. The report is based on the processing of information provided by the European Pacemaker Patient Identification Card. We received information from 111 hospitals, with a total of 12 555 cards, representing 32.1% of all the estimated activity. The use of conventional generators and resynchronization devices was 820 and 73 units per million population, respectively. The mean age of the patients receiving an implantation was 77.7 years, and more than 50% of the devices were implanted in patients over 80 years of age. Overall, 58.6% of the implants and 58.8% of the replacements were performed in men. All of the endocardial leads employed were bipolar, 81.5% had an active fixation system, and 16.5% were compatible with magnetic resonance. Although dual chamber sequential pacing continues to be more widespread, pacing with VVI/R mode is used because up to 23.8% of the patients with sinus node disease are in sinus rhythm, as are 24.1% of those with atrioventricular block. The total use of pacemaker generators in Spain has increased by about 5% with respect to 2014. The majority of the leads implanted are of active fixation, and less than 20% are protected from magnetic resonance. The factors directly related to the selection of pacing mode are age and sex. In around 20% of patients, the choice of the pacing mode could be improved. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Magnetic resonance imaging in patients with cardiac implanted electronic devices: focus on contraindications to magnetic resonance imaging protocols.

PubMed

Horwood, Laura; Attili, Anil; Luba, Frank; Ibrahim, El-Sayed H; Parmar, Hemant; Stojanovska, Jadranka; Gadoth-Goodman, Sharon; Fette, Carey; Oral, Hakan; Bogun, Frank

2017-05-01

Magnetic resonance imaging (MRI) has been reported to be safe in patients with cardiac implantable electronic devices (CIED) provided a specific protocol is followed. The objective of this study was to assess whether this is also true for patients excluded from published protocols. A total of 160 MRIs were obtained in 142 consecutive patients with CIEDs [106 patients had an implantable cardioverter defibrillator (ICD) and 36 had a pacemaker implanted] using an adapted, pre-specified protocol. A cardiac MRI was performed in 95 patients, and a spinal/brain MRI was performed in 47 patients. Forty-six patients (32%) had either abandoned leads (n = 10), and/or were pacemaker dependent with an implanted ICD (n = 19), had recently implanted CIEDs (n = 1), and/or had a CIED device with battery depletion (n = 2), and/or a component of the CIED was recalled or on advisory (n = 32). No major complications occurred. Some device parameters changed slightly, but significantly, right after or at 1-week post-MRI without requiring any reprogramming. In one patient with an ICD on advisory, the pacing rate changed inexplicably during one of his two MRIs from 90 to 50 b.p.m. Using a pre-specified protocol, cardiac and non-cardiac MRIs were performed in CIED patients with pacemaker dependency, abandoned leads, or depleted batteries without occurrence of major adverse events. Patients with devices on advisory need to be monitored carefully during MRI, especially if they are pacemaker dependent. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

Primary prevention of atrial fibrillation: does the atrial lead position influence the incidence of atrial arrhythmias in patients with sinus node dysfunction? Results from the PASTA Trial.

PubMed

Spitzer, Stefan G; Wacker, Petra; Gazarek, Steffen; Malinowski, Klaus; Schibgilla, Volker

2009-12-01

PASTA (pacing of the atria in sinus node disease) is a prospective and randomized trial, assessing the effect of different atrial lead positions on the atrial fibrillation (AF) incidence in patients with sinus node disease (SND). The atrial lead position is randomized to: (a) free right atrial wall, (b) right atrial appendage (RAA), (c) coronary sinus ostium (CS-Os), or (d) dual site right atrial pacing (CS-Os + RAA). The pacemakers (Vitatron Selection 9000 or Prevent AF, Vitatron B.V., Arnhem, The Netherlands) are programmed in DDDR 70 mode and the total follow-up duration is 24 months. To describe the atrial rhythm state, pacemaker-derived data (arrhythmia counter) were assessed for AF episodes. AF was considered as evident, if the AF burden (time in AF related to follow-up interval) was >1% (i.e., 15 min/d). Follow-up data after 24 months were evaluated. The analysis evaluates 142 patients (77 male, 74.5 +/- 7.8 years). There was no statistical significant difference with respect to the occurrence of AF between the four groups after 24 months (A: 36%; B: 38%, C: 32%, D: 48%). The percentage of atrial/ventricular pacing was in A: 78/76%, in B: 84/81%, in C: 70/65%, and in D: 79/69%. These differences were not significant. The evaluation of the AF burden >1% and the total AF burden after 24 months did not show differences in the incidence of AF in patients with dual chamber pacemaker therapy for SND. We were not able to demonstrate a significant influence of right atrial lead position on the incidence of AF recurrence.

Prevalence and mechanism of tricuspid regurgitation following implantation of endocardial leads for pacemaker or cardioverter-defibrillator.

PubMed

Al-Mohaissen, Maha A; Chan, Kwan Leung

2012-03-01

Endocardial lead-induced tricuspid regurgitation has not been well recognized, either clinically or echocardiographically, and yet it is likely a preventable iatrogenic disease. In severe cases, it can lead to right ventricular failure and require tricuspid valve surgery. This complication will become increasingly important, because the numbers of permanent pacemakers and implantable cardioverter-defibrillators are expected to increase because of the aging population and the expanding capabilities of these devices. Published studies are largely retrospective, and serial studies to assess the time course of the development of tricuspid regurgitation are lacking. The mechanisms and severity of tricuspid regurgitation may not be well evaluated by two-dimensional echocardiography. Real-time three-dimensional echocardiography appears to be a promising technique to evaluate the mechanism of tricuspid regurgitation and may allow the early detection of patients who will develop severe lead-induced tricuspid regurgitation. A better understanding of the mechanism of lead-induced tricuspid regurgitation will be essential to the development of preventive strategies, which can then be tested in future clinical trials. Copyright © 2012 American Society of Echocardiography. Published by Mosby, Inc. All rights reserved.

Optimal pacing for right ventricular and biventricular devices: minimizing, maximizing, and right ventricular/left ventricular site considerations.

PubMed

Gillis, Anne M

2014-10-01

The results from numerous clinical studies provide guidance for optimizing outcomes related to RV or biventricular pacing in the pacemaker and ICD populations. (1) Programming algorithms to minimize RV pacing is imperative in patients with dual-chamber pacemakers who have intrinsic AV conduction or intermittent AV conduction block. (2) Dual-chamber ICDs should be avoided in candidates without an indication for bradycardia pacing. (3) Alternate RV septal pacing sites may be considered at the time of pacemaker implantation. (4) Biventricular pacing may be beneficial in some patients with mild LV dysfunction. (5) LV lead placement at the site of latest LV activation is desirable. (6) Programming CRT systems to achieve biventricular/LV pacing >98.5% is important. (7) Protocols for AV and VV optimization in patients with CRT are not recommended after device implantation but may be considered for CRT nonresponders. (8) Novel algorithms to maximize the benefit of CRT are in evolution further.

Assessing access to MRI of patients with magnetic resonance-conditional pacemaker and implantable cardioverter defibrillator systems: the Really ProMRI study design.

PubMed

Maglia, Giampiero; Curnis, Antonio; Brieda, Marco; Anaclerio, Matteo; Caccavo, Vincenzo; Bonfanti, Paolo; Melissano, Donato; Caravati, Fabrizio; Giovene, Lisa; Gargaro, Alessio

2015-10-01

Despite the fact that magnetic resonance (MR)-conditional pacemaker and lead systems have been introduced more than 5 years ago, it is still not clear whether they have actually facilitated the access of pacemaker patients to this important diagnostic tool. Factors limiting MR scans in daily practice in patients with MR-conditional cardiac implantable electronic device (CIED) systems may be related to organizational, cultural and sometimes legal aspects. The Really ProMRI registry is an ongoing survey designed to assess the annual rate of MR examinations in patients with MR-conditional implants, with either pacemakers or implantable cardioverter defibrillators, and to detect the main factors limiting MRI. The primary endpoint of the Really ProMRI registry is to assess the current access to MRI of patients with MR-conditional pacemaker or implantable cardioverter defibrillator systems during normal practice. Data in the literature reported a 17% annual incidence of medical conditions requiring MRI in CIED patients. The Really ProMRI registry has been designed to detect 4.5% absolute difference with an 80% statistical power, by recruiting 600 patients already implanted with MR-conditional CIED implant. Patients will be followed up for 1 year, during which they will be asked to refer any prescription, execution or denial of an MR examination by patient questionnaires and original source documents. The ongoing Really ProMRI registry will assess the actual rate of and factors limiting the access to MRI for patients with MR-conditional CIEDs.

Do prehospital discharge pacemaker checks provide any additional clinical benefit?

PubMed

Wheelan, Kevin R; Legge, Darlene M; Sakowski, Brent C; Bruce, Susan S; Roberts, David C; Johnston, L Murphy; Moore, B Jane; Beveridge, Thomas P; Wells, Peter J; Vallabahn, Ravi; Donsky, Michael S; Franklin, Jay O

2005-08-01

We performed a retrospective analysis of 250 records of consecutive, newly implanted, pacemaker patients from a single center to determine the rate of postimplant complications and observations discovered before and during the prehospital discharge evaluation. No observations occurred in 246 of 250 patients (98.4%) (1-sided 95% confidence interval 96.4%). Of the 250 patients, 4 had observations that were discovered at the prehospital discharge check and required reprogramming to increase the sensitivity safety margin (3 atrial and 1 ventricular). We documented only 1 complication that was discovered before the predischarge evaluation through telemetry and resulted in an atrial lead revision.

Transvenous demand Pacemaker Treatment for intermittent complete Heart Block in a Cat.

PubMed

Forterre, S; Nürnberg, J H; Forterre, F; Skrodzki, M; Lange, P E

2001-11-01

A 13-year-old male neutered domestic shorthaired cat had repeated syncopal episodes over a 6 month period, which had variable duration and continued to increase in frequency. Intermittent ventricular asystole, due to complete heart block, and hyperthyroidism were documented. As the syncopal episodes did not respond to a 4-week medical treatment and symptoms became severe, a transvenous ventricular demand pacemaker system (VVIM) was implanted via the external jugular vein. The unipolar lead was tunneled subcutaneously and connected with the generator in a preformed ventral abdominal muscle pocket. During follow up of 18-months there were no recurrences of the syncopal episodes.

Clinical use of isotope cardiac pacemakers (in German)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wagner, J.; Kreutzberg, B.

1973-01-01

Plutoninm-235 having a half-life of 86.4 yrs has proved suitable as a long-life energy source for a cardiac pacemaker. The radiation dose of this pacemaker is below the I. C. R. P.-recommended values. As the isotope pacemaker costs three times as much as a conventional pacemaker, the merits of implanting an isotope pacemaker vs. the conventional kind are discussed. A survey is given of the cases in which an isotope pacemaker has been used. (GE)

Pacemaker Dependency after Cardiac Surgery: A Systematic Review of Current Evidence.

PubMed

Steyers, Curtis M; Khera, Rohan; Bhave, Prashant

2015-01-01

Severe postoperative conduction disturbances requiring permanent pacemaker implantation frequently occur following cardiac surgery. Little is known about the long-term pacing requirements and risk factors for pacemaker dependency in this population. We performed a systematic review of the literature addressing rates and predictors of pacemaker dependency in patients requiring permanent pacemaker implantation after cardiac surgery. Using a comprehensive search of the Medline, Web of Science and EMBASE databases, studies were selected for review based on predetermined inclusion and exclusion criteria. A total of 8 studies addressing the endpoint of pacemaker-dependency were identified, while 3 studies were found that addressed the recovery of atrioventricular (AV) conduction endpoint. There were 10 unique studies with a total of 780 patients. Mean follow-up ranged from 6-72 months. Pacemaker dependency rates ranged from 32%-91% and recovery of AV conduction ranged from 16%-42%. There was significant heterogeneity with respect to the definition of pacemaker dependency. Several patient and procedure-specific variables were found to be independently associated with pacemaker dependency, but these were not consistent between studies. Pacemaker dependency following cardiac surgery occurs with variable frequency. While individual studies have identified various perioperative risk factors for pacemaker dependency and non-resolution of AV conduction disease, results have been inconsistent. Well-conducted studies using a uniform definition of pacemaker dependency might identify patients who will benefit most from early permanent pacemaker implantation after cardiac surgery.

Recurrent FUO due to intermittent Enterobacter cloacae bacteremias from an infected pacemaker lead diagnosed by gallium scan.

PubMed

Cunha, Burke A; Jimada, Ismail

2018-01-01

Fever of unknown origin (FUO) refers to fevers of ≥101° F that persist for ≥3 weeks and remain undiagnosed after a focused inpatient or outpatient workup. FUO may be due to infectious, malignant/neoplastic, rheumatic/inflammatory, or miscellaneous disorders. Recurrent FUOs are due to the same causes of classical FUOs. Recurrent FUOs may have continuous or intermittent fevers and are particularly difficult to diagnose. With intermittent fever, recurrent FUO diagnostic tests are best obtained during fever episodes. With recurrent FUOs, the periodicity of febrile episodes is unpredictable. We present a case of a 70-year-old male who presented with recurrent FUO. Multiple extensive FUO workups failed to determine the source of his fever. During his last two episodes of fever/chills, blood cultures were positive for Enterobacter cloacae. Episodic E. cloacae bacteremias suggested a device-related infection, and the patient had a penile implant and permanent pacemaker (PPM). Following febrile episodes, he was treated with multiple courses of appropriate antibiotics, but subsequently fever/chills recurred. Since a device-associated infection was suspected, indium and PET scans were done, but were negative. The source of his intermittent E. cloacae bacteremias was finally demonstrated by gallium scan showing enhanced uptake on a cardiac lead, but not the penile implant or PPM. Gallium scanning remains useful in workup of FUOs, particularly when false-negative indium or PET scans are suspected. The involved pacemaker lead was explanted, grew E. cloacae and the patient has since remained fever free.

A pacemaker magnet check alone is sufficient for the majority of patients postpacemaker implant.

PubMed

Jones, Michael A; Wong, Kelvin C K; Qureshi, Norman; Rajappan, Kim; Bashir, Yaver; Betts, Timothy R

2014-12-01

Patients postpacemaker implant can undergo a full assessment by pacing system programmer (PSP) or a magnet check. The former takes longer, but provides more detailed information; a magnet-mode assessment is faster, but provides only capture data in an asynchronous pacing mode. A magnet-mode assessment alone may be sufficient in most cases, and current clinical practice varies considerably. A retrospective single-center assessment of all pacemaker implants receiving PSP and magnet checks between September 2009 and April 2010. Patient records were reviewed. The results of PSP and magnet checks and any subsequent device-related management were noted. A total of 168 patients underwent pacemaker implantation, magnet-mode assessment, and then PSP interrogation during this period. Magnet-mode assessment revealed a problem in only one patient-failure of atrial capture, leading to subsequent atrial lead repositioning. None of the remaining 167 patients have a serious problem at PSP interrogation; six had minor issues at PSP check, none of which required repeat surgical intervention. The magnet-mode test only provides information on lead capture in an asynchronous pacing mode, which is the most essential data postoperatively. Our study has suggested that a magnet-mode assessment without PSP interrogation may be sufficient in the immediate postimplant assessment of these patients. Routine postimplant PSP interrogation is time consuming, labor intensive, and adds only minimal additional benefit to the safe management of these patients above and beyond a magnet check, coupled with informed assessment of the associated electrocardiogram/rhythm strip, clinical examination, and chest x-ray. ©2014 Wiley Periodicals, Inc.

21 CFR 870.3640 - Indirect pacemaker generator function analyzer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Indirect pacemaker generator function analyzer... Indirect pacemaker generator function analyzer. (a) Identification. An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or...

21 CFR 870.3640 - Indirect pacemaker generator function analyzer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Indirect pacemaker generator function analyzer... Indirect pacemaker generator function analyzer. (a) Identification. An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or...

21 CFR 870.3640 - Indirect pacemaker generator function analyzer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Indirect pacemaker generator function analyzer... Indirect pacemaker generator function analyzer. (a) Identification. An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or...

21 CFR 870.3640 - Indirect pacemaker generator function analyzer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Indirect pacemaker generator function analyzer... Indirect pacemaker generator function analyzer. (a) Identification. An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or...

Risk of advanced heart block during extradural anaesthesia in patients with right bundle branch block and left anterior hemiblock.

PubMed

Coriat, P; Harari, A; Ducardonet, A; Tarot, J P; Viars, P

1981-05-01

Electrocardiographic recording by Holter monitoring demonstrated the absence of any modification, however minimal, of the intranodal conduction during surgical procedures under extradural anaesthesia in 20 patients with right bundle branch block (RBBB) and left anterior hemiblock (LAHB) but without symptoms. These data suggest that extradural anaesthesia can be used safely in patients with asymptomatic chronic RBBB and LAHB without prophylactic insertion of pacemakers. However, patients having experienced either syncope or transient Mobitz II second degree AV block are likely to have a trifascicular block and increased risk of advanced heart block during extradural anaesthesia.

Postmortem analysis of encapsulation around long-term ventricular endocardial pacing leads.

PubMed

Candinas, R; Duru, F; Schneider, J; Lüscher, T F; Stokes, K

1999-02-01

To analyze the site and thickness of encapsulation around ventricular endocardial pacing leads and the extent of tricuspid valve adhesion, from today's perspective, with implications for lead removal and sensor location. Gross cardiac postmortem analysis was performed in 11 cases (8 female and 3 male patients; mean age, 78+/-7 years). None of the patients had died because of pacemaker malfunction. The mean implant time was 61+/-60 months (range, 4 to 184). The observations ranged from encapsulation only at the tip of the pacing lead to complete encapsulation along the entire length of the pacing lead within the right ventricle. Substantial areas of adhesion at the tricuspid valve apparatus were noted in 7 of the 11 cases (64%). The firmly attached leads could be removed only by dissection, and in some cases, removal was possible only by damaging the associated structures. No specific optimal site for sensor placement could be identified along the ventricular portion of the pacing leads; however, the fibrotic response was relatively less prominent in the atrial chamber. Extensive encapsulation is present in most long-term pacemaker leads, which may complicate lead removal. The site and thickness of encapsulation seem to be highly variable. Tricuspid valve adhesion, which is usually underestimated, may be severe. In contrast to earlier reports, our study demonstrates that the extent of fibrotic encapsulation may not be related to the duration since lead implantation. Moreover, we noted no ideal encapsulation-free site for sensors on the ventricular portion of long-term pacing leads.

Association between hospital procedure volume and early complications after pacemaker implantation: results from a large, unselected, contemporary cohort of the German nationwide obligatory external quality assurance programme.

PubMed

Nowak, Bernd; Tasche, Karl; Barnewold, Linda; Heller, Günther; Schmidt, Boris; Bordignon, Stefano; Chun, K R Julian; Fürnkranz, Alexander; Mehta, Rajendra H

2015-05-01

Several studies demonstrated an inverse relationship between cardioverter-defibrillator implantation volume and complication rates, suggesting better outcomes for higher volume centres. However, the association of institutional procedural volume with patient outcomes for permanent pacemaker (PPM) implantation remains less known, especially in decentralized implantation systems. We performed retrospective examination of data on patients undergoing PPM from the German obligatory quality assurance programme (2007-12) to evaluate the relationship of hospital PPM volume (categorized into quintiles of their mean annual volume) with risk-adjusted in-hospital surgical complications (composite of pneumothorax, haemothorax, pericardial effusion, or pocket haematoma, all requiring intervention, or device infection) and pacemaker lead dislocation. Overall 430 416 PPM implantations were documented in 1226 hospitals. Systems included dual (72.8%) and single (25.8%) chamber PPM and cardiac resynchronization therapy (CRT) devices (1.1%). Complications included surgical (0.92%), and ventricular (0.99%), and atrial (1.22%) lead dislocation. Despite an increase in relatively complex procedures (dual chamber, CRT), there was a significant decrease in the procedural and fluoroscopy times and complications from lowest to highest implantation volume quintiles (P for trend <0.0001). The greatest difference was observed between the lowest (1-50 implantations/year-reference group) and the second-lowest (51-90 implantations/year) quintile: surgical complications [odds ratio (OR) 0.69; confidence interval (CI) 0.60-0.78], atrial lead dislocations (OR 0.69; CI 0.59-0.80), and ventricular lead dislocations (OR 0.73; CI 0.63-0.84). Hospital annual PPM volume was directly related to indication-based implantation of relatively more complex PPM and yet inversely with procedural times and rates of early surgical complications and lead dislocations. Thus, our data suggest better performance and lower complications with increasing procedural volume. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

21 CFR 870.3610 - Implantable pacemaker pulse generator.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implantable pacemaker pulse generator. 870.3610... pacemaker pulse generator. (a) Identification. An implantable pacemaker pulse generator is a device that has... implantable pacemaker pulse generator device that was in commercial distribution before May 28, 1976, or that...

21 CFR 870.3610 - Implantable pacemaker pulse generator.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implantable pacemaker pulse generator. 870.3610... pacemaker pulse generator. (a) Identification. An implantable pacemaker pulse generator is a device that has... implantable pacemaker pulse generator device that was in commercial distribution before May 28, 1976, or that...

Racing of the biological pacemaker.

PubMed

Yu, Han-Gang

2009-01-01

Over the past decade, rapid progress in the molecular studies of cardiac ion channels and stem cells biology has led to efforts to create a biological pacemaker to supplement the widely-used electronic pacemaker. We will review the main concepts of cardiac pacemaker activities in different heart regions and the approaches to design a working biological pacemaker. We will focus on how to use the gene- and cell-based approaches to meet the requirements of a working biological pacemaker. Possible future development and precautions for creation of an effective biological pacemaker superior to the electronic counterpart are also discussed along with recent patents.

Pacemaker Dependency after Cardiac Surgery: A Systematic Review of Current Evidence

PubMed Central

2015-01-01

Background Severe postoperative conduction disturbances requiring permanent pacemaker implantation frequently occur following cardiac surgery. Little is known about the long-term pacing requirements and risk factors for pacemaker dependency in this population. Methods We performed a systematic review of the literature addressing rates and predictors of pacemaker dependency in patients requiring permanent pacemaker implantation after cardiac surgery. Using a comprehensive search of the Medline, Web of Science and EMBASE databases, studies were selected for review based on predetermined inclusion and exclusion criteria. Results A total of 8 studies addressing the endpoint of pacemaker-dependency were identified, while 3 studies were found that addressed the recovery of atrioventricular (AV) conduction endpoint. There were 10 unique studies with a total of 780 patients. Mean follow-up ranged from 6–72 months. Pacemaker dependency rates ranged from 32%-91% and recovery of AV conduction ranged from 16%-42%. There was significant heterogeneity with respect to the definition of pacemaker dependency. Several patient and procedure-specific variables were found to be independently associated with pacemaker dependency, but these were not consistent between studies. Conclusions Pacemaker dependency following cardiac surgery occurs with variable frequency. While individual studies have identified various perioperative risk factors for pacemaker dependency and non-resolution of AV conduction disease, results have been inconsistent. Well-conducted studies using a uniform definition of pacemaker dependency might identify patients who will benefit most from early permanent pacemaker implantation after cardiac surgery. PMID:26470027

[Permanent cardiac pacing for chronic symptomatic atrioventricular block in uremic hemodialysed patients. A prospective study].

PubMed

Arsenescu, Cătălina; Georgescu, G I M; Covic, A; Briotă, Laura

2002-01-01

Though sudden cardiac death accounts for as much as 15% of all cause mortality in uremia, reports concerning advanced A-V block, requiring permanent cardiac pacing in end-stage renal disease (ESRD) hemodialysed (HD) patients are very few. This is the first long term prospective study reporting on systematic permanent pacemaker implantation, in a cohort of ESRD patients from a single HD unit. Between 01/06/1997 and 30/12/2001, 396 pacemakers were inserted for advanced, symptomatic A-V block in our institution, including 5 in ESRD, HD patients (M/F--4/1, age 47-73, M +/- SD--61 +/- 12 years) from a single dialysis center, treating 137 patients during the study period. Thus, the incidence and prevalence of A-V defects treated by permanent pacing in uremic patients was 0.81% and 3.65% respectively. Conversely, the incidence and prevalence of ESRD treated by hemodialysis, among patients with advanced A-V conduction disturbances, requiring permanent pacing were 0.28% and 1.26%. Mitral valve calcifications were present in all patients; 3 subjects also had extensive aortic valve calcifications. Left ventricular hypertrophy (echocardiographic Framingham criteria) was present in 4 patients, but the systolic function (ejection fraction and fractional shortening index) was normal in all cases, although a clinical picture of chronic heart failure was seen in 3 subjects preoperatively. A-V conduction defects were attributed to extensive metastatic calcifications, involving the cardiac squeleton, consecutive to severe hyperparathyroidism and inadvertent use of calcitriol and calcium carbonate as phosphate binders. No technical difficulties, short or long-term complications related to pacemaker implantation (4 VVI and 1 VVD devices) were encountered. Acute threshold and sensing values were similar with those of non-uremic patients. During follow-up, one patients died from a non cardiac death. If optimal hemodialysis is provided, benefits of permanent pacing are equal in uremic or non uremic patients and pacemaker implantation should be instituted as a prompt life-saving method in all dialysis patients with chronic symptomatic advanced A-V blocks.

Implant experience with an implantable hemodynamic monitor for the management of symptomatic heart failure.

PubMed

Steinhaus, David; Reynolds, Dwight W; Gadler, Fredrik; Kay, G Neal; Hess, Mike F; Bennett, Tom

2005-08-01

Management of congestive heart failure is a serious public health problem. The use of implantable hemodynamic monitors (IHMs) may assist in this management by providing continuous ambulatory filling pressure status for optimal volume management. The Chronicle system includes an implanted monitor, a pressure sensor lead with passive fixation, an external pressure reference (EPR), and data retrieval and viewing components. The tip of the lead is placed near the right ventricular outflow tract to minimize risk of sensor tissue encapsulation. Implant technique and lead placement is similar to that of a permanent pacemaker. After the system had been successfully implanted in 148 patients, the type and frequency of implant-related adverse events were similar to a single-chamber pacemaker implant. R-wave amplitude was 15.2 +/- 6.7 mV and the pressure waveform signal was acceptable in all but two patients in whom presence of artifacts required lead repositioning. Implant procedure time was not influenced by experience, remaining constant throughout the study. Based on this evaluation, permanent placement of an IHM in symptomatic heart failure patients is technically feasible. Further investigation is warranted to evaluate the use of the continuous hemodynamic data in management of heart failure patients.

Society position statement : Canadian Cardiovascular Society/Canadian Anesthesiologists' Society/Canadian Heart Rhythm Society joint position statement on the perioperative management of patients with implanted pacemakers, defibrillators, and neurostimulating devices.

PubMed

Healey, Jeff S; Merchant, Richard; Simpson, Chris; Tang, Timothy; Beardsall, Marianne; Tung, Stanley; Fraser, Jennifer A; Long, Laurene; van Vlymen, Janet M; Manninen, Pirjo; Ralley, Fiona; Venkatraghavan, Lashmi; Yee, Raymond; Prasloski, Bruce; Sanatani, Shubhayan; Philippon, François

2012-04-01

There are more than 200,000 Canadians living with permanent pacemakers or implantable defibrillators, many of whom will require surgery or invasive procedures each year. They face potential hazards when undergoing surgery; however, with appropriate planning and education of operating room personnel, adverse device-related outcomes should be rare. This joint position statement from the Canadian Cardiovascular Society (CCS) and the Canadian Anesthesiologists' Society (CAS) has been developed as an accessible reference for physicians and surgeons, providing an overview of the key issues for the preoperative, intraoperative, and postoperative care of these patients. The document summarizes the limited published literature in this field, but for most issues, relies heavily on the experience of the cardiologists and anesthesiologists who contributed to this work. This position statement outlines how to obtain information about an individual's type of pacemaker or implantable defibrillator and its programming. It also stresses the importance of determining if a patient is highly pacemaker-dependent and proposes a simple approach for nonelective evaluation of dependency. Although the document provides a comprehensive list of the intraoperative issues facing these patients, there is a focus on electromagnetic interference resulting from electrocautery and practical guidance is given regarding the characteristics of surgery, electrocautery, pacemakers, and defibrillators which are most likely to lead to interference. The document stresses the importance of preoperative consultation and planning to minimize complications. It reviews the relative merits of intraoperative magnet use vs reprogramming of devices and gives examples of situations where one or the other approach is preferable.

Reduction of the pace polarization artefact for capture detection applications by a tri-phasic stimulation pulse.

PubMed

Sutton, R; Fröhlig, G; de Voogt, W G; Goethals, M; Hintringer, F; Kennergren, C; Scanu, P; Guilleman, D; Treese, N; Hartung, W M; Stammwitz, E; Muetstege, A

2004-11-01

This study investigated the ability to minimize pace polarization artefacts (PPA) by adjusting the post-stimulus pulse duration of a tri-phasic stimulation pulse. Adjustment of the stimulation pulse was enabled by downloading special study software into an already implanted pacemaker. Tests were performed in a total of 296 atrial leads and 311 ventricular leads. Both chronic and acute leads were included in the study. Statistically significant differences were found in the initial PPA (without any adjustment of the stimulus pulse) between atrial and ventricular leads. In addition, significant differences were observed among various lead models with respect to changes over time in the initial ventricular PPA. Successful PPA reduction was defined as a reduction of the PPA below 0.5 mV for atrial leads and below 1 mV for ventricular leads. Results show a success rate for ventricular and atrial PPA reduction of 97.8% and 98.7%, respectively. Threshold tests showed that after reduction of the PPA loss of ventricular capture can be reliably detected. However, atrial threshold tests showed many false positive evoked response detections. In addition, unexpectedly high evoked response amplitudes were observed in the atrium after reduction of the PPA. Results from additional measurements suggest that these high atrial evoked response amplitudes come from the influence of the input filter of the pacemaker.

Initial experience with remote magnetic navigation for left ventricular lead placement.

PubMed

Mischke, Karl; Knackstedt, Christian; Schmid, Michael; Hatam, Nima; Becker, Michael; Spillner, Jan; Fache, Kerstin; Kelm, Malte; Schauerte, Patrick

2009-08-01

A novel magnetic navigation system allows remote steering of guidewires and catheters. This system may be used for left ventricular lead placement for cardiac resynchronization therapy (CRT). We sought to evaluate the feasibility and safety of magnetic guidewire navigation for CRT procedures. 123 consecutive patients underwent CRT implantation/revision procedures (including pacemaker upgrades in n=22 and left ventricular lead placement after dislocation in n=4 patients). Left ventricular lead placement in a coronary sinus side branch was performed either conventionally or using magnetic navigation. The magnetic navigation system (Niobe) consists of two permanent magnets creating a steerable magnetic field. Guidewires with integrated magnets align to the magnetic field and were used for over-the-wire implantation of pacemaker leads in the coronary sinus. Patients were assigned to conventional (n=93) or magnetic (n=30) navigation according to room availability. Venography of the coronary venous system was performed to select a target vessel for lead implantation. Guidewire access to the target vessel was achieved in 100% using magnetic navigation compared to 87% with the conventional approach (P < 0.05). Implantation success rates, total procedure and fluoroscopy times did not differ significantly between groups. No periprocedural death and no intraoperative device dysfunction occurred in either group.The magnetic guidewire ruptured in one patient. Left ventricular lead placement using magnetic guidewire navigation to engage the desired coronary sinus side branch can be successfully performed for CRT.

Electrical interference in non-competitive pacemakers

PubMed Central

Sowton, E.; Gray, K.; Preston, T.

1970-01-01

Patients with 41 implanted non-competitive pacemakers were investigated. A variety of domestic electrical equipment, a motor-car, and a physiotherapy diathermy apparatus were each operated in turn at various ranges from the patient. Interference effects on pacemaker function were assessed on the electrocardiograph. Medtronic demand 5841 pacemakers were stopped by diathermy while Cordis Ectocor pacemakers developed a fast discharge rate. Cordis triggered pacemakers (both Atricor and Ectocor) were sensitive to interference from many items of domestic equipment and the motor car. The Elema EM153 ran at an increased rate when an electric razor was running close to the pacemaker. The Devices demand 2980 and the Medtronic demand 5841 were not affected by the domestic equipment tested. The significance of interference effects is discussed in relation to pacemaker design. Images PMID:5470044

Pacemaker Use Following Heart Transplantation

PubMed Central

Mallidi, Hari R.; Bates, Michael

2017-01-01

Background: The incidence of permanent pacemaker implantation after orthotopic heart transplantation has been reported to be 2%-24%. Transplanted hearts usually exhibit sinus rhythm in the operating room following reperfusion, and most patients do not exhibit significant arrhythmias during the postoperative period. However, among the patients who do exhibit abnormalities, pacemakers may be implanted for early sinus node dysfunction but are rarely used after 6 months. Permanent pacing is often required for atrioventricular block. A different cohort of transplant patients presents later with bradycardia requiring pacemaker implantation, reported to occur in approximately 1.5% of patients. The objectives of this study were to investigate the indications for pacemaker implantation, compare the need for pacemakers following bicaval vs biatrial anastomosis, and examine the long-term outcomes of heart transplant patients who received pacemakers. Methods: For this retrospective, case-cohort, single-institution study, patients were identified from clinical research and administrative transplant databases. Information was supplemented with review of the medical records. Standard statistical techniques were used, with chi-square testing for categorical variables and the 2-tailed t test for continuous variables. Survival was compared with the use of log-rank methods. Results: Between January 1968 and February 2008, 1,450 heart transplants were performed at Stanford University. Eighty-four patients (5.8%) were identified as having had a pacemaker implanted. Of these patients, 65.5% (55) had the device implanted within 30 days of transplantation, and 34.5% (29) had late implantation. The mean survival of patients who had an early pacemaker implant was 6.4 years compared to 7.7 years for those with a late pacemaker implant (P<0.05). Sinus node dysfunction and heart block were the most common indications for pacemaker implantation. Starting in 1997, a bicaval technique was used for implantation. The incidence of pacemaker implantation by technique was 2.0% for bicaval and 9.1% for biatrial (P=0.001). Significantly more rejection episodes occurred in the pacemaker group (2.67 ± 2.18) compared with the no-pacemaker group (2.01 ± 2.05) (P<0.05). Conclusion: Our results show a decreased pacemaker need after bicaval anastomosis and that more patients who needed a pacemaker after transplantation had a pretransplant diagnosis of ischemic cardiomyopathy. In our cohort, the need for a permanent pacemaker was also associated with older donor grafts and an increase in the number of treated rejection episodes. PMID:28331443

[Wide QRS tachycardia preceded by pacemaker spikes].

PubMed

Romero, M; Aranda, A; Gómez, F J; Jurado, A

2014-04-01

The differential diagnosis and therapeutic management of wide QRS tachycardia preceded by pacemaker spike is presented. The pacemaker-mediated tachycardia, tachycardia fibrillo-flutter in patients with pacemakers, and runaway pacemakers, have a similar surface electrocardiogram, but respond to different therapeutic measures. The tachycardia response to the application of a magnet over the pacemaker could help in the differential diagnosis, and in some cases will be therapeutic, as in the case of a tachycardia-mediated pacemaker. Although these conditions are diagnosed and treated in hospitals with catheterization laboratories using the application programmer over the pacemaker, patients presenting in primary care clinic and emergency forced us to make a diagnosis and treat the haemodynamically unstable patient prior to referral. Copyright © 2012 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España. All rights reserved.

Radiation induced failures of complementary metal oxide semiconductor containing pacemakers: a potentially lethal complication

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lewin, A.A.; Serago, C.F.; Schwade, J.G.

1984-10-01

New multi-programmable pacemakers frequently employ complementary metal oxide semiconductors (CMOS). This circuitry appears more sensitive to the effects of ionizing radiation when compared to the semiconductor circuits used in older pacemakers. A case of radiation induced runaway pacemaker in a CMOS device is described. Because of this and other recent reports of radiation therapy-induced CMOS type pacemaker failure, these pacemakers should not be irradiated. If necessary, the pacemaker can be shielded or moved to a site which can be shielded before institution of radiation therapy. This is done to prevent damage to the CMOS circuit and the life threatening arrythmiasmore » which may result from such damage.« less

Sacral neuromodulation and cardiac pacemakers.

PubMed

Roth, Ted M

2010-08-01

Potential for cross-talk between cardiac pacemakers and sacral neuromodulation remains speculative. We present a case series of patients with cardiac pacemakers who underwent staged Interstim (Medtronic, Minneapolis, MN) implantation and patients who had pulse generator implantation who later required cardiac pacemakers. No cross-talk was demonstrated in either group. Sacral neuromodulation appears to be safe in the setting of cardiac pacemakers without cardioversion/defibrillation technology.

On the Evolution of the Cardiac Pacemaker

PubMed Central

Burkhard, Silja; van Eif, Vincent; Garric, Laurence; Christoffels, Vincent M.; Bakkers, Jeroen

2017-01-01

The rhythmic contraction of the heart is initiated and controlled by an intrinsic pacemaker system. Cardiac contractions commence at very early embryonic stages and coordination remains crucial for survival. The underlying molecular mechanisms of pacemaker cell development and function are still not fully understood. Heart form and function show high evolutionary conservation. Even in simple contractile cardiac tubes in primitive invertebrates, cardiac function is controlled by intrinsic, autonomous pacemaker cells. Understanding the evolutionary origin and development of cardiac pacemaker cells will help us outline the important pathways and factors involved. Key patterning factors, such as the homeodomain transcription factors Nkx2.5 and Shox2, and the LIM-homeodomain transcription factor Islet-1, components of the T-box (Tbx), and bone morphogenic protein (Bmp) families are well conserved. Here we compare the dominant pacemaking systems in various organisms with respect to the underlying molecular regulation. Comparative analysis of the pathways involved in patterning the pacemaker domain in an evolutionary context might help us outline a common fundamental pacemaker cell gene programme. Special focus is given to pacemaker development in zebrafish, an extensively used model for vertebrate development. Finally, we conclude with a summary of highly conserved key factors in pacemaker cell development and function. PMID:29367536

Dosimetric perturbations due to an implanted cardiac pacemaker in MammoSite{sup Registered-Sign} treatment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sung, Wonmo; Kim, Siyong; Kim, Jung-in

2012-10-15

Purpose: To investigate dose perturbations for pacemaker-implanted patients in partial breast irradiation using high dose rate (HDR) balloon brachytherapy. Methods: Monte Carlo (MC) simulations were performed to calculate dose distributions involving a pacemaker in Ir-192 HDR balloon brachytherapy. Dose perturbations by varying balloon-to-pacemaker distances (BPD = 50 or 100 mm) and concentrations of iodine contrast medium (2.5%, 5.0%, 7.5%, and 10.0% by volume) in the balloon were investigated for separate parts of the pacemaker (i.e., battery and substrate). Relative measurements using an ion-chamber were also performed to confirm MC results. Results: The MC and measured results in homogeneous media withoutmore » a pacemaker agreed with published data within 2% from the balloon surface to 100 mm BPD. Further their dose distributions with a pacemaker were in a comparable agreement. The MC results showed that doses over the battery were increased by a factor of 3, compared to doses without a pacemaker. However, there was no significant dose perturbation in the middle of substrate but up to 70% dose increase in the substrate interface with the titanium capsule. The attenuation by iodine contrast medium lessened doses delivered to the pacemaker by up to 9%. Conclusions: Due to inhomogeneity of pacemaker and contrast medium as well as low-energy photons in Ir-192 HDR balloon brachytherapy, the actual dose received in a pacemaker is different from the homogeneous medium-based dose and the external beam-based dose. Therefore, the dose perturbations should be considered for pacemaker-implanted patients when evaluating a safe clinical distance between the balloon and pacemaker.« less

Impact of pacemaker mode in patients with atrioventricular conduction disturbance after trans-catheter aortic valve implantation.

PubMed

Takahashi, Masao; Badenco, Nicolas; Monteau, Jacques; Gandjbakhch, Estelle; Extramiana, Fabrice; Urena, Marina; Karam, Nicole; Marijon, Eloi; Algalarrondo, Vincent; Teiger, Emmanuel; Lellouche, Nicolas

2018-03-14

This study aimed to assess the impact of pacemaker mode programming on clinical outcomes in patients with high-degree atrioventricular conduction disturbance (AVCD) after transcatheter aortic valve implantation (TAVI). Although high-degree AVCD after TAVI can receive pacemaker, recovery of the AVCD is often observed. Specific pacemaker algorithms (AAI-DDD mode switch) are available which favor spontaneous atrioventricular conduction. Of 1,621 consecutive multi-center TAVI patients, 269 (16.4%) received pacemaker. We retrospectively included 91 patients with persistent high-degree AVCD at hospital discharge. Pacemaker dependency was defined as absence, inadequate intrinsic ventricular rhythm, or ventricular pacing time > 95% on pacemaker interrogation during follow-up. Comparison of heart failure hospitalization and death between conventional DDD (cDDD) and other modes was examined (AAI-DDD and VVI). During a mean follow-up duration of 13 months, the pacemaker dependency rate was 52.8%. Patients with cDDD mode (N = 36: 40.0%) had significantly more pacemaker dependency. Multivariate analysis showed that cDDD mode was independently associated with pacemaker dependency (odds ratio = 3.63, P = 0.03). Moreover, cDDD patients had a significant higher incidence of heart failure hospitalization (Hospitalization: cDDD vs. others = 45.4% vs. 18.2%, P = 0.03) and had a higher incidence of mortality (Death: cDDD vs. the others = 27.0% vs. 4.4%, P = 0.06). Up to half of patients implanted for high-degree AVCD after TAVI had conduction recovery. Patients with cDDD programming at hospital discharge had more pacemaker dependency and a worse cardiac prognosis. Thus, pacemaker mode should be systematically set to promote spontaneous atrioventricular conduction in patients with pacemaker implantation after TAVI. © 2018 Wiley Periodicals, Inc.

High prevalence of baffle leaks in adults after atrial switch operations for transposition of the great arteries.

PubMed

De Pasquale, Gabriella; Bonassin Tempesta, Francesca; Lopes, Bruno Santos; Babic, Daniela; Oxenius, Angela; Seeliger, Theresa; Gruner, Christiane; Tanner, Felix C; Biaggi, Patric; Attenhofer Jost, Christine; Greutmann, Matthias

2017-05-01

To determine the prevalence of baffle leaks in adults after atrial switch operations for transposition of the great arteries, as these may predispose to paradoxical embolic events, particularly in patients with transvenous pacemaker or defibrillator leads. We routinely perform contrast echocardiography with agitated saline in all patients after atrial switch operations. For this study, we analysed patients who had saline contrast echocardiography between 2010 and 2012. The presence of baffle leaks and the severity of right-to-left shunting were assessed. We compared baseline characteristics and oxygen saturation at rest and during exercise between patients with and without baffle leaks. A total of 65 patients (56 Senning and 9 Mustard repair) without previously known baffle leaks were included (mean age 32 ± 8 years, 77% males). Right-to-left shunting was identified in 42 patients (65%) and occurred without provocation manoeuvres in 88%. There were no differences in baseline characteristics, echocardiographic findings, or exercise capacity between patients with and without baffle leaks, except for lower oxygen saturation at peak exercise in those with baffle leaks (29% had oxygen saturations below 90% at peak exercise compared to none without baffle leaks, P = 0.011). Four patients with baffle leaks had previous implantation of transvenous pacemaker leads; one of them had suffered a stroke. Two other patients with baffle leaks had a history of potential embolic stroke. Because of the high prevalence of baffle leaks in adults after atrial switch operations, we propose routine screening with agitated saline contrast, particularly prior to implantation of transvenous pacemaker or defibrillator leads. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

Modeling the emergence of circadian rhythms in a clock neuron network.

PubMed

Diambra, Luis; Malta, Coraci P

2012-01-01

Circadian rhythms in pacemaker cells persist for weeks in constant darkness, while in other types of cells the molecular oscillations that underlie circadian rhythms damp rapidly under the same conditions. Although much progress has been made in understanding the biochemical and cellular basis of circadian rhythms, the mechanisms leading to damped or self-sustained oscillations remain largely unknown. There exist many mathematical models that reproduce the circadian rhythms in the case of a single cell of the Drosophila fly. However, not much is known about the mechanisms leading to coherent circadian oscillation in clock neuron networks. In this work we have implemented a model for a network of interacting clock neurons to describe the emergence (or damping) of circadian rhythms in Drosophila fly, in the absence of zeitgebers. Our model consists of an array of pacemakers that interact through the modulation of some parameters by a network feedback. The individual pacemakers are described by a well-known biochemical model for circadian oscillation, to which we have added degradation of PER protein by light and multiplicative noise. The network feedback is the PER protein level averaged over the whole network. In particular, we have investigated the effect of modulation of the parameters associated with (i) the control of net entrance of PER into the nucleus and (ii) the non-photic degradation of PER. Our results indicate that the modulation of PER entrance into the nucleus allows the synchronization of clock neurons, leading to coherent circadian oscillations under constant dark condition. On the other hand, the modulation of non-photic degradation cannot reset the phases of individual clocks subjected to intrinsic biochemical noise.

Wireless power transfer for a pacemaker application.

PubMed

Vulfin, Vladimir; Sayfan-Altman, Shai; Ianconescu, Reuven

2017-05-01

An artificial pacemaker is a small medical device that uses electrical impulses, delivered by electrodes contracting the heart muscles, to regulate the beating of the heart. The pacemaker is implanted under the skin, and uses for many years regular non-rechargeable batteries. However, the demand for rechargeable batteries in pacemakers increased, and the aim of this work is to design an efficient charging system for pacemakers.

Connectivity of Pacemaker Neurons in the Neonatal Rat Superficial Dorsal Horn

PubMed Central

Ford, Neil C.; Arbabi, Shahriar; Baccei, Mark L.

2014-01-01

Pacemaker neurons with an intrinsic ability to generate rhythmic burst-firing have been characterized in lamina I of the neonatal spinal cord, where they are innervated by high-threshold sensory afferents. However, little is known about the output of these pacemakers, as the neuronal populations which are targeted by pacemaker axons have yet to be identified. The present study combines patch clamp recordings in the intact neonatal rat spinal cord with tract-tracing to demonstrate that lamina I pacemaker neurons contact multiple spinal motor pathways during early life. Retrograde labeling of premotor interneurons with the trans-synaptic virus PRV-152 revealed the presence of burst-firing in PRV-infected lamina I neurons, thereby confirming that pacemakers are synaptically coupled to motor networks in the spinal ventral horn. Notably, two classes of pacemakers could be distinguished in lamina I based on cell size and the pattern of their axonal projections. While small pacemaker neurons possessed ramified axons which contacted ipsilateral motor circuits, large pacemaker neurons had unbranched axons which crossed the midline and ascended rostrally in the contralateral white matter. Recordings from identified spino-parabrachial and spino-PAG neurons indicated the presence of pacemaker activity within neonatal lamina I projection neurons. Overall, these results show that lamina I pacemakers are positioned to regulate both the level of activity in developing motor circuits as well as the ascending flow of nociceptive information to the brain, thus highlighting a potential role for pacemaker activity in the maturation of pain and sensorimotor networks in the CNS. PMID:25380417

Magnetic resonance imaging-conditional devices: Luxury or real clinical need?

PubMed

Mavrogeni, Sophie I; Poulos, George; Kolovou, Genovefa; Theodorakis, George

Although the risk of MRI scanning on patients with conventional devices is lower than initially thought, the patient's safety can only be guaranteed when using MRI-conditional devices. The most important modifications in MRI-conditional devices include a) Reduction in ferromagnetic components to reduce magnetic attraction and susceptibility artifacts; b) Replacement of the reed switch by a Hall sensor in order to avoid unpredictable reed switch behavior; c) Lead coil design to minimize lead heating and electrical current induction; d) Filter circuitry to prevent damage to the internal power supply; and e) Dedicated pacemaker programming to prevent inappropriate pacemaker inhibition and competing rhythms. Although many companies claim to have MRI-conditional devices, adoption in clinical practice is limited because a) Not all companies have MRI-conditional devices approved for both 1.5 and 3T; b) Not all companies offer the option of unlimited MRI scanning (without an exclusion zone in the thorax); c) Certain companies allow only a 30-min MRI scanning and only in afebrile patients; and d) Despite having MRI-conditional pacemakers, certain companies do not have MRI-conditional defibrillators and CRT systems. It is clear that this new technology opens the door for MRI to a growing number of patients; however, the widespread adoption of MRI-conditional devices will depend on real-life issues, such as cost, clinical indications for such a device and the permanent education of health care professionals. Copyright © 2017 Hellenic Society of Cardiology. Published by Elsevier B.V. All rights reserved.

Pacemaker explosions in crematoria: problems and possible solutions

PubMed Central

Gale, Christopher P; Mulley, Graham P

2002-01-01

The number of artificial cardiac pacemakers is increasing, as is the number of bodies being cremated. Because of the explosive potential of pacemakers when heated, a statutory question on the cremation form asks whether the deceased has a pacemaker and if so whether it has been removed. We sent a questionnaire to all the crematoria in the UK enquiring about the frequency, consequences and prevention of pacemaker explosions. We found that about half of all crematoria in the UK experience pacemaker explosions, that pacemaker explosions may cause structural damage and injury and that most crematoria staff are unaware of the explosive potential of implantable cardiac defibrillators. Crematoria staff rely on the accurate completion of cremation forms, and doctors who sign cremation forms have a legal obligation to provide such information. PMID:12091510

Endocardial Energy Harvesting by Electromagnetic Induction.

PubMed

Zurbuchen, Adrian; Haeberlin, Andreas; Bereuter, Lukas; Pfenniger, Alois; Bosshard, Simon; Kernen, Micha; Philipp Heinisch, Paul; Fuhrer, Juerg; Vogel, Rolf

2018-02-01

cardiac pacemakers require regular medical follow-ups to ensure proper functioning. However, device replacements due to battery depletion are common and account for ∼25% of all implantation procedures. Furthermore, conventional pacemakers require pacemaker leads which are prone to fractures, dislocations or isolation defects. The ensuing surgical interventions increase risks for the patients and costs that need to be avoided. in this study, we present a method to harvest energy from endocardial heart motions. We developed a novel generator, which converts the heart's mechanical into electrical energy by electromagnetic induction. A mathematical model has been introduced to identify design parameters strongly related to the energy conversion efficiency of heart motions and fit the geometrical constraints for a miniaturized transcatheter deployable device. The implemented final design was tested on the bench and in vivo. the mathematical model proved an accurate method to estimate the harvested energy. For three previously recorded heart motions, the model predicted a mean output power of 14.5, 41.9, and 16.9 μW. During an animal experiment, the implanted device harvested a mean output power of 0.78 and 1.7 μW at a heart rate of 84 and 160 bpm, respectively. harvesting kinetic energy from endocardial motions seems feasible. Implanted at an energetically favorable location, such systems might become a welcome alternative to extend the lifetime of cardiac implantable electronic device. the presented endocardial energy harvesting concept has the potential to turn pacemakers into battery- and leadless systems and thereby eliminate two major drawbacks of contemporary systems.

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to change noninvasively one or more of...

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker electrode function tester. 870.3720... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3720 Pacemaker electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is...

21 CFR 870.3730 - Pacemaker service tools.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker service tools. 870.3730 Section 870.3730...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3730 Pacemaker service tools. (a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches...

21 CFR 870.5550 - External transcutaneous cardiac pacemaker (noninvasive).

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External transcutaneous cardiac pacemaker... § 870.5550 External transcutaneous cardiac pacemaker (noninvasive). (a) Identification. An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to...

21 CFR 870.5550 - External transcutaneous cardiac pacemaker (noninvasive).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false External transcutaneous cardiac pacemaker... § 870.5550 External transcutaneous cardiac pacemaker (noninvasive). (a) Identification. An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to...

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker electrode function tester. 870.3720... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3720 Pacemaker electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker generator function analyzer. 870.3630... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker generator function analyzer. (a) Identification. A pacemaker generator function analyzer is a device that is...

21 CFR 870.3730 - Pacemaker service tools.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker service tools. 870.3730 Section 870.3730...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3730 Pacemaker service tools. (a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches...

21 CFR 870.3730 - Pacemaker service tools.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker service tools. 870.3730 Section 870.3730...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3730 Pacemaker service tools. (a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches...

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker electrode function tester. 870.3720... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3720 Pacemaker electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to change noninvasively one or more of...

21 CFR 870.3730 - Pacemaker service tools.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker service tools. 870.3730 Section 870.3730...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3730 Pacemaker service tools. (a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches...

21 CFR 870.5550 - External transcutaneous cardiac pacemaker (noninvasive).

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false External transcutaneous cardiac pacemaker... § 870.5550 External transcutaneous cardiac pacemaker (noninvasive). (a) Identification. An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to...

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker electrode function tester. 870.3720... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3720 Pacemaker electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to noninvasively change one or more of...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker generator function analyzer. 870.3630... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker generator function analyzer. (a) Identification. A pacemaker generator function analyzer is a device that is...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker generator function analyzer. 870.3630... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker generator function analyzer. (a) Identification. A pacemaker generator function analyzer is a device that is...

21 CFR 870.3730 - Pacemaker service tools.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker service tools. 870.3730 Section 870.3730...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3730 Pacemaker service tools. (a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker generator function analyzer. 870.3630... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker generator function analyzer. (a) Identification. A pacemaker generator function analyzer is a device that is...

21 CFR 870.5550 - External transcutaneous cardiac pacemaker (noninvasive).

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false External transcutaneous cardiac pacemaker... § 870.5550 External transcutaneous cardiac pacemaker (noninvasive). (a) Identification. An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to noninvasively change one or more of...

21 CFR 870.5550 - External transcutaneous cardiac pacemaker (noninvasive).

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External transcutaneous cardiac pacemaker... § 870.5550 External transcutaneous cardiac pacemaker (noninvasive). (a) Identification. An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to...

Evaluation of the effects of electric fields on implanted cardiac pacemakers. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Moss, A.J.; Carstensen, E.

1985-02-01

The effects of extra high voltage (EHV) transmission line electric fields on pacemaker function were evaluated in 11 patients with seven different implanted pacemaker models from four manufacturers. Alteration in pacemaker function was demonstrated in five unipolar units (three different models) from two manufacturers during exposure to electric fields ranging from 2 to 9 kV/m, with total body currents from 47 to 175 ..mu..A. These electric fields and body currents are representative of values that can be encountered by individuals standing beneath EHV transmission lines. Transient alterations in pacemaker function observed in this study included inappropriate triggered activity, inhibition ofmore » impulse generation, reduction in rate, and reversion from demand to asynchronous mode. Electromagnetic interference from high voltage transmission lines can induce alterations in pacemaker function in certain designs of these devices. However, pacemaker manufacturers can incorporate appropriate circuits in the pacemaker design to eliminate this problem. 8 references.« less

Electromagnetic interference with pacemakers caused by portable media players.

PubMed

Thaker, Jay P; Patel, Mehul B; Jongnarangsin, Krit; Liepa, Valdis V; Thakur, Ranjan K

2008-04-01

Electromagnetic fields generated by electrical devices may cause interference with permanent pacemakers. Media players are becoming a common mode of portable entertainment. The most common media players used worldwide are iPods. These devices are often carried in a shirt chest pocket, which may place the devices close to an implanted pacemaker. The purpose of this study was to determine if iPods cause interference with pacemakers. In this prospective, single-blinded study, 100 patients who had cardiac pacemakers were tested with four types of iPods to assess for interference. Patients were monitored by a single-channel ECG monitor as well as the respective pacemaker programmer via the telemetry wand. iPods were tested by placing them 2 inches anterior to the pacemaker and wand for up to 10 seconds. To simulate actual use, standard-issue headphones were plugged into the iPods. To maintain consistency, the volume was turned up maximally, and the equalizer was turned off. A subset of 25 patients underwent testing on 2 separate days to assess for reproducibility of interference. Pacemaker interference was categorized as type I or type II telemetry interference. Type I interference was associated with atrial and/or ventricular high rates on rate histograms. Type II interference did not affect pacemaker rate counters. Electromagnetic emissions from the four iPods also were evaluated in a Faraday cage to determine the mechanism of the observed interference. One hundred patients (63 men and 37 women; mean age 77.1 +/- 7.6 years) with 11 single-chamber pacemakers and 89 dual-chamber pacemakers underwent 800 tests. The incidence of any type of interference was 51% of patients and 20% of tests. Type I interference was seen in 19% of patients and type II in 32% of patients. Reproducibility testing confirmed that interference occurred regardless of pacing configuration (unipolar or bipolar), pacing mode (AAI, VVI, or DDD), and from one day to the next. Electromagnetic emissions testing from the iPods demonstrated maximum emissions in the pacemaker carrier frequency range when the iPod was turned "on" with the headphones attached. iPods placed within 2 inches of implanted pacemakers monitored via the telemetry wand can cause interference with pacemakers.

Noise-induced effects on multicellular biopacemaker spontaneous activity: Differences between weak and strong pacemaker cells

NASA Astrophysics Data System (ADS)

Aghighi, Alireza; Comtois, Philippe

2017-09-01

Self-organization of spontaneous activity of a network of active elements is important to the general theory of reaction-diffusion systems as well as for pacemaking activity to initiate beating of the heart. Monolayer cultures of neonatal rat ventricular myocytes, consisting of resting and pacemaker cells, exhibit spontaneous activation of their electrical activity. Similarly, one proposed approach to the development of biopacemakers as an alternative to electronic pacemakers for cardiac therapy is based on heterogeneous cardiac cells with resting and spontaneously beating phenotypes. However, the combined effect of pacemaker characteristics, density, and spatial distribution of the pacemaker cells on spontaneous activity is unknown. Using a simple stochastic pattern formation algorithm, we previously showed a clear nonlinear dependency of spontaneous activity (occurrence and amplitude of spontaneous period) on the spatial patterns of pacemaker cells. In this study, we show that this behavior is dependent on the pacemaker cell characteristics, with weaker pacemaker cells requiring higher density and larger clusters to sustain multicellular activity. These multicellular structures also demonstrated an increased sensitivity to voltage noise that favored spontaneous activity at lower density while increasing temporal variation in the period of activity. This information will help researchers overcome the current limitations of biopacemakers.

21 CFR 870.1750 - External programmable pacemaker pulse generator.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false External programmable pacemaker pulse generator. 870.1750 Section 870.1750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... External programmable pacemaker pulse generator. (a) Identification. An external programmable pacemaker...

21 CFR 870.1750 - External programmable pacemaker pulse generator.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false External programmable pacemaker pulse generator. 870.1750 Section 870.1750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... External programmable pacemaker pulse generator. (a) Identification. An external programmable pacemaker...

21 CFR 870.1750 - External programmable pacemaker pulse generator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External programmable pacemaker pulse generator. 870.1750 Section 870.1750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... External programmable pacemaker pulse generator. (a) Identification. An external programmable pacemaker...

21 CFR 870.1750 - External programmable pacemaker pulse generator.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false External programmable pacemaker pulse generator. 870.1750 Section 870.1750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... External programmable pacemaker pulse generator. (a) Identification. An external programmable pacemaker...

21 CFR 870.1750 - External programmable pacemaker pulse generator.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External programmable pacemaker pulse generator. 870.1750 Section 870.1750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... External programmable pacemaker pulse generator. (a) Identification. An external programmable pacemaker...

21 CFR 870.3710 - Pacemaker repair or replacement material.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker repair or replacement material. 870.3710... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3710 Pacemaker repair or replacement material. (a) Identification. A pacemaker repair or replacement material is an...

21 CFR 870.3670 - Pacemaker charger.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker charger. 870.3670 Section 870.3670 Food... DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3670 Pacemaker charger. (a) Identification. A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable...

21 CFR 870.3670 - Pacemaker charger.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker charger. 870.3670 Section 870.3670 Food... DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3670 Pacemaker charger. (a) Identification. A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable...

21 CFR 870.3710 - Pacemaker repair or replacement material.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker repair or replacement material. 870.3710... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3710 Pacemaker repair or replacement material. (a) Identification. A pacemaker repair or replacement material is an...

21 CFR 870.3670 - Pacemaker charger.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker charger. 870.3670 Section 870.3670 Food... DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3670 Pacemaker charger. (a) Identification. A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable...

21 CFR 870.3710 - Pacemaker repair or replacement material.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker repair or replacement material. 870.3710... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3710 Pacemaker repair or replacement material. (a) Identification. A pacemaker repair or replacement material is an...

21 CFR 870.3670 - Pacemaker charger.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker charger. 870.3670 Section 870.3670 Food... DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3670 Pacemaker charger. (a) Identification. A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable...

21 CFR 870.3710 - Pacemaker repair or replacement material.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker repair or replacement material. 870.3710... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3710 Pacemaker repair or replacement material. (a) Identification. A pacemaker repair or replacement material is an...

Effect of electric and magnetic fields near an HVDC converter terminal on implanted cardiac pacemakers. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Frazier, M.J.

1980-08-01

The electromagnetic fields associated with HVDC converters and transmission lines constitute a unique environment for persons with implanted cardiac pacemakers. A measurement program has been conducted to assess the potential interfering effects of these harmonically rich fields on implanted pacemakers. The experimental procedures that were employed take into account the combined effects of the electric and magnetic fields. The effect of the resulting body current on the response of six pacemakers was assessed in the laboratory, using a previously developed model to relate body current to pacemaker pickup voltage. The results show that R-wave pacemaker reversion can be expected atmore » some locations within the converter facility, but that a large safety margin for unperturbed pacemaker operation exists beneath the transmission lines.« less

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a...

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a...

21 CFR 870.3690 - Pacemaker test magnet.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker test magnet. 870.3690 Section 870.3690...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3690 Pacemaker test magnet. (a) Identification. A pacemaker test magnet is a device used to test an inhibited or triggered type...

21 CFR 870.3690 - Pacemaker test magnet.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker test magnet. 870.3690 Section 870.3690...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3690 Pacemaker test magnet. (a) Identification. A pacemaker test magnet is a device used to test an inhibited or triggered type...

21 CFR 870.3690 - Pacemaker test magnet.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker test magnet. 870.3690 Section 870.3690...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3690 Pacemaker test magnet. (a) Identification. A pacemaker test magnet is a device used to test an inhibited or triggered type...

21 CFR 870.3610 - Implantable pacemaker pulse generator.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implantable pacemaker pulse generator. 870.3610 Section 870.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... pacemaker pulse generator. (a) Identification. An implantable pacemaker pulse generator is a device that has...

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a...

21 CFR 870.3690 - Pacemaker test magnet.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker test magnet. 870.3690 Section 870.3690...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3690 Pacemaker test magnet. (a) Identification. A pacemaker test magnet is a device used to test an inhibited or triggered type...

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a...

Radiation effect on implanted pacemakers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pourhamidi, A.H.

1983-10-01

It was previously thought that diagnostic or therapeutic ionizing radiation did not have an adverse effect on the function of cardiac pacemakers. Recently, however, some authors have reported damaging effect of therapeutic radiation on cardiac pulse generators. An analysis of a recently-extracted pacemaker documented the effect of radiation on the pacemaker pulse generator.

Minimal invasive right ventricular and atrial pacemaker lead repositioning as a first alternative is superior in avoiding pocket complications with passive fixation leads.

PubMed

Osztheimer, István; Szilágyi, Szabolcs; Pongor, Zsuzsanna; Zima, Endre; Molnár, Levente; Tahin, Tamás; Özcan, Emin Evren; Széplaki, Gábor; Merkely, Béla; Gellér, László

2017-06-01

Lead dislocations of pacemaker systems are reported in all and even in high-volume centers. Repeated procedures necessitated by lead dislocations are associated with an increased risk of complications. We investigated a minimal invasive method for right atrial and ventricular lead repositioning. The minimal invasive method was applied only when passive fixation leads were implanted. During the minimal invasive procedure, a steerable catheter was advanced through the femoral vein to move the distal end of the lead to the appropriate position. Retrospective data collection was conducted in all patients with minimal invasive and with conventional method, at a single center between September 2006 and December 2012. Forty-five minimal invasive lead repositionings were performed, of which eight were acutely unsuccessful and nine electrodes re-dislocated after the procedure. One hundred two leads were repositioned with opening of the pocket during the same time, including the ones with unsuccessful minimal invasive repositionings. One procedure was acutely unsuccessful in this group and four re-dislocations happened. A significant difference of success rates was noted (66.6% vs. 95.1%, p = 0.001). One complication was observed during the minimal invasive lead repositionings (left ventricular lead microdislodgement). Open-pocket procedures showed different types of complications (pneumothorax, subclavian artery puncture, pericardial effusion, hematoma, fever, device-associated infection which necessitated explantation, atrial lead dislodgement while repositioning the ventricular one, deterioration of renal function). The minimal invasive method as a first alternative is safe and feasible. In those cases when it cannot be carried out successfully, the conventional method is applicable.

Programmable Pacemaker

NASA Technical Reports Server (NTRS)

1980-01-01

St. Jude Medical's Cardiac Rhythm Management Division, formerly known as Pacesetter Systems, Inc., incorporated Apollo technology into the development of the programmable pacemaker system. This consists of the implantable pacemaker together with a physician's console containing the programmer and a data printer. Physician can communicate with patient's pacemaker by means of wireless telemetry signals transmitted through the communicating head held over the patient's chest. Where earlier pacemakers deliver a fixed type of stimulus once implanted, Programalith enables surgery free "fine tuning" of device to best suit the patient's changing needs.

Redo surgery after permanent pacemaker implantation: performance indicator of surgical techniques and pacing technology.

PubMed

Bharat, Vijaya

2004-01-01

The incidence of permanent pacemaker-related complications is reducing due to advancement of technology and increasing operator experience. There are only few series from India reporting the annual complication rates from a single center over the years. This is a series of 782 pacemakers implanted over 20 years in a secondary healthcare set-up. Eighty-two patients underwent redo surgery, either for a procedure-related complication (n=34) or for replacement of a malfunctioning/end-of-life pacemaker (n=48). Through critical analysis and corrective measures, all the procedural complications were reduced to less than 4% of the annual implantations. The introduction of a pacemaker follow-up clinic contributed to reducing the rate of elective replacement for battery depletion from 19.17% of the implanted VVI pacemakers to 0.63%. Despite being a low-volume center, with less than 100 pacemakers implanted annually, the performance of our pacing practice has shown continuous improvement.

How revealing are insertable loop recorders in pediatrics?

PubMed

Frangini, Patricia A; Cecchin, Frank; Jordao, Ligia; Martuscello, Maria; Alexander, Mark E; Triedman, John K; Walsh, Edward P; Berul, Charles I

2008-03-01

An insertable loop recorder (ILR) in patients with infrequent syncope or palpitations may be useful to decide management strategies, including clinical observation, medical therapy, pacemaker, or implantable cardioverter defibrillator (ICD). We sought to determine the diagnostic utility of the Reveal ILR (Medtronic, Inc., Minneapolis, MN, USA) in pediatric patients. Retrospective review of clinical data, indications, findings, and therapeutic decision in 27 consecutive patients who underwent ILR implantation from 1998-2007. The median age was 14.8 years (2-25 years). Indications were syncope in 24 patients and recurrent palpitations in three. Overall, eight patients had structural heart disease (six congenital heart disease, one hypertrophic cardiomyopathy, one Kawasaki), five had previous documented ventricular arrhythmias with negative evaluation including electrophysiology study, and three patients had QT prolongation. Tilt testing was performed in 10 patients, of which five had neurocardiogenic syncope but recurrent episodes despite medical therapy. After median three months (1-20 months), 17 patients presented with symptoms and the ILR memory was analyzed in 16 (no episode stored in one due to full device memory), showing asystole or transient atrioventricular (AV) block (2), sinus bradycardia (6), or normal sinus rhythm (8). Among asymptomatic patients, 3/10 had intermittent AV block or long pauses, automatically detected and stored by the ILR. In 19 of 20 patients, ILR was diagnostic (95%) and five subsequently underwent pacemaker implantation, while seven patients remained asymptomatic without ILR events. Notably, no life-threatening events were detected. The ILR was explanted in 22 patients after a median of 22 months, two due to pocket infection, 12 for battery depletion and eight after clear documentation of nonmalignant arrhythmia. The ILR in pediatrics is a useful adjunct to other diagnostic studies. Patient selection is critical as the ILR should not be utilized for malignant arrhythmias. A diagnosis is attained in the majority of symptomatic patients, predominantly bradyarrhythmias including pauses and intermittent AV block.

Wenckebach upper rate response in single chamber pacemaker.

PubMed

Barold, S S

2000-07-01

The Medtronic Minix pacemaker during normal function in the VVT mode was found to exhibit a Wenckenbach upper rate response similar to that of dual chamber devices. This behavior occurred only when the upper rate interval was longer than the pacemaker refractory period. In a single chamber device this response may simulate pacemaker malfunction.

Modern Perspectives on Numerical Modeling of Cardiac Pacemaker Cell

PubMed Central

Maltsev, Victor A.; Yaniv, Yael; Maltsev, Anna V.; Stern, Michael D.; Lakatta, Edward G.

2015-01-01

Cardiac pacemaking is a complex phenomenon that is still not completely understood. Together with experimental studies, numerical modeling has been traditionally used to acquire mechanistic insights in this research area. This review summarizes the present state of numerical modeling of the cardiac pacemaker, including approaches to resolve present paradoxes and controversies. Specifically we discuss the requirement for realistic modeling to consider symmetrical importance of both intracellular and cell membrane processes (within a recent “coupled-clock” theory). Promising future developments of the complex pacemaker system models include the introduction of local calcium control, mitochondria function, and biochemical regulation of protein phosphorylation and cAMP production. Modern numerical and theoretical methods such as multi-parameter sensitivity analyses within extended populations of models and bifurcation analyses are also important for the definition of the most realistic parameters that describe a robust, yet simultaneously flexible operation of the coupled-clock pacemaker cell system. The systems approach to exploring cardiac pacemaker function will guide development of new therapies, such as biological pacemakers for treating insufficient cardiac pacemaker function that becomes especially prevalent with advancing age. PMID:24748434

Short- and long-term need for permanent pacemaker after transcatheter implantation of the Edwards Sapien aortic valve prosthesis.

PubMed

Moreno, Raúl; Calvo, Luis; Sánchez-Recalde, Angel; Galeote, Guillermo; Jiménez-Valero, Santiago; López, Teresa; Plaza, Ignacio; González-Davia, Rosa; Ramírez, Ulises; Mesa, Jose Maria; Moreno-Gomez, Isidro; López-Sendón, José-Luis

2015-11-01

A permanent pacemaker is frequently needed after transcatheter aortic valve implantation, but the available data are mainly on the CoreValve system. To evaluate the need for new permanent pacemaker after implantation of the Edwards Sapien device, as well as related factors. We included the first 100 patients treated with the Edwards Sapien device at our institution. Of these, 12 had a permanent pacemaker before the procedure, and thus our study population was the remaining 88 patients. A permanent pacemaker was indicated in eight patients (9.1%) during hospitalization or at 30 days. After discharge, another four patients needed a pacemaker (at 42 days and three, 18, and 30 months). Two variables were associated with the need for pacemaker during hospitalization: previous dialysis (13% vs. 1%, p=0.042) and complete right bundle branch block before the procedure (25% vs. 5%, p=0.032). More than one month after the procedure, the characteristics associated with the need for pacemaker were plasma creatinine level (2.5±1.7 vs. 1.3±0.6 mg/dl, p=0.001) and previous myocardial infarction (50% vs. 10%, p=0.013). The rate of pacemaker implantation with the Edwards Sapien device was 9.1%. Right bundle branch block and dialysis were associated with this complication.

Circadian Activators Are Expressed Days before They Initiate Clock Function in Late Pacemaker Neurons from Drosophila.

PubMed

Liu, Tianxin; Mahesh, Guruswamy; Houl, Jerry H; Hardin, Paul E

2015-06-03

Circadian pacemaker neurons in the Drosophila brain control daily rhythms in locomotor activity. These pacemaker neurons can be subdivided into early or late groups depending on whether rhythms in period (per) and timeless (tim) expression are initiated at the first instar (L1) larval stage or during metamorphosis, respectively. Because CLOCK-CYCLE (CLK-CYC) heterodimers initiate circadian oscillator function by activating per and tim transcription, a Clk-GFP transgene was used to mark when late pacemaker neurons begin to develop. We were surprised to see that CLK-GFP was already expressed in four of five clusters of late pacemaker neurons during the third instar (L3) larval stage. CLK-GFP is only detected in postmitotic neurons from L3 larvae, suggesting that these four late pacemaker neuron clusters are formed before the L3 larval stage. A GFP-cyc transgene was used to show that CYC, like CLK, is also expressed exclusively in pacemaker neurons from L3 larval brains, demonstrating that CLK-CYC is not sufficient to activate per and tim in late pacemaker neurons at the L3 larval stage. These results suggest that most late pacemaker neurons develop days before novel factors activate circadian oscillator function during metamorphosis. Copyright © 2015 the authors 0270-6474/15/358662-10$15.00/0.

Third-generation mobile phones (UMTS) do not interfere with permanent implanted pacemakers.

PubMed

Ismail, Mohamed M; Badreldin, Akmal M A; Heldwein, Matthias; Hekmat, Khosro

2010-07-01

Third-generation mobile phones, UMTS (Universal Mobile Telecommunication System), were recently introduced in Europe. The safety of these devices with regard to their interference with implanted pacemakers is as yet unknown and is the point of interest in this study. The study comprised 100 patients with permanent pacemaker implantation between November 2004 and June 2005. Two UMTS cellular phones (T-Mobile, Vodafone) were tested in the standby, dialing, and operating mode with 23 single-chamber and 77 dual-chamber pacemakers. Continuous surface electrocardiograms (ECGs), intracardiac electrograms, and marker channels were recorded when calls were made by a stationary phone to cellular phone. All pacemakers were tested under a "worst-case scenario," which includes a programming of the pacemaker to unipolar sensing and pacing modes and inducing of a maximum sensitivity setting during continuous pacing of the patient. Patients had pacemaker implantation between June 1990 and April 2005. The mean age was 68.4 +/- 15.1 years. Regardless of atrial and ventricular sensitivity settings, both UMTS mobile phones (Nokia 6650 and Motorola A835) did not show any interference with all tested pacemakers. In addition, both cellular phones did not interfere with the marker channels and the intracardiac ECGs of the pacemakers. Third-generation mobile phones are safe for patients with permanent pacemakers. This is due to the high-frequency band for this system (1,800-2,200 MHz) and the low power output between 0.01 W and 0.25 W.

E AND M CIRCADIAN PACEMAKER NEURONS USE DIFFERENT PDF RECEPTOR SIGNALOSOME COMPONENTS IN DROSOPHILA

PubMed Central

Duvall, Laura B.

2014-01-01

We used real-time imaging to detect cAMP levels in neurons of intact fly brains to study mechanisms of circadian pacemaker synchronization by the neuropeptide PDF in Drosophila. PDF receptor (PDF-R) is expressed by both M (sLNv) and E (LNd) pacemaker sub-classes and is coupled to Gsα in both cases. We previously reported that PDF-R in M pacemakers elevates cAMP levels by activating the ortholog of mammalian Adenylate Cyclase 3 (AC3), but that AC3 disruptions had no effect on E pacemaker sensitivity to PDF. Here we show that PDF-R in E pacemakers activates a different AC isoform, AC78C, an ortholog of mammalian AC8. Knockdown of AC78C by transgenic RNAi substantially reduces, but does not completely abrogate, PDF responses in these E pacemakers. The knockdown effect is intact when restricted to mature stages, suggesting a physiological and not a development role for AC78C in E pacemakers. The AC78C phenotype is rescued by over-expression of AC78C, but not by over-expression of the rutabaga AC. AC78C over-expression does not disrupt PDF responses in these E pacemakers, and neither AC78C knockdown nor its over-expression disrupted locomotor rhythms. Finally, knockdown of two AKAPs, nervy and AKAP 200 partially reduces LNd PDF responses. These findings begin to identify the components of E pacemaker PDF-R signalosomes and indicate they are distinct from PDF-R signalosomes in M pacemakers: we propose they contain AC78C and at least one other AC. PMID:23929551

E and M circadian pacemaker neurons use different PDF receptor signalosome components in drosophila.

PubMed

Duvall, Laura B; Taghert, Paul H

2013-08-01

We used real-time imaging to detect cAMP levels in neurons of intact fly brains to study the mechanisms of circadian pacemaker synchronization by the neuropeptide pigment dispersing factor (PDF) in Drosophila. PDF receptor (PDF-R) is expressed by both M (sLNv) and E (LNd) pacemaker subclasses and is coupled to G(sα) in both cases. We previously reported that PDF-R in M pacemakers elevates cAMP levels by activating the ortholog of mammalian adenylate cyclase 3 (AC3) but that AC3 disruptions had no effect on E pacemaker sensitivity to PDF. Here, we show that PDF-R in E pacemakers activates a different AC isoform, AC78C, an ortholog of mammalian AC8. Knockdown of AC78C by transgenic RNAi substantially reduces, but does not completely abrogate, PDF responses in these E pacemakers. The knockdown effect is intact when restricted to mature stages, suggesting a physiological and not a development role for AC78C in E pacemakers. The AC78C phenotype is rescued by the overexpression of AC78C but not by overexpression of the rutabaga AC. AC78C overexpression does not disrupt PDF responses in these E pacemakers, and neither AC78C knockdown nor its overexpression disrupted locomotor rhythms. Finally, knockdown of 2 AKAPs, nervy and AKAP200, partially reduces LNd PDF responses. These findings begin to identify the components of E pacemaker PDF-R signalosomes and indicate that they are distinct from PDF-R signalosomes in M pacemakers: we propose they contain AC78C and at least 1 other AC.

[Atrial fibrillation before and after pacemaker implantation (WI and DDD) in patients with complete atrioventricular block].

PubMed

Matusik, Paweł; Woznica, Natalia; Lelakowsk, Jacek

2010-05-01

Atrial fibrillation (AF) is a frequent problem of patients with pacemakers, and depends not only on disease but also on stimulation method. The aim of the study was to estimate the prevalence of AF before and after pacemaker implantation as well as to assess the influence of VVI and DDD cardiac pacing on onset of AF in patients with complete atrioventricularblock (AVB). We included 155 patients controlled between 2000 and 2008 in Pacemaker Clinic because of AVB III degree, treated with VVI or DDD pacemaker implantation. Information about the health status of the patients was gathered from medical documentation and analysis of clinical ambulatory electrocardiograms. The study group comprised of 68 women and 87 men, mean age 68.7 +/- 13.9 years during implantation. 69% of patients had VVI pacemaker. There were 72.3% of patients with sinus rhythm before pacemaker implantation. During follow-up 4 +/- 2.8 years in 19.6% cases onset of atrial fibrillation de novo was diagnosed (in 31.3% in VVI mode vs. 2.2% in DDD mode; p = 0.00014). Mean time to AF since implantation was approximately 2.5 years. In VVI group (21 persons) amounted 32.1 months, while in 1 patient with DDD pacemaker 18 months. Between group with AF after implantation and with sinus rhythm preserved there was no statistically significant difference in age or gender (p = 0.89512 and p = 0.1253, respectively). Prevalence of atrial fibrillation after pacemaker implantation increased to 40%. Atrial fibrillation is frequent in patients before and after pacemaker implantation, especially in patients stimulated in VVI mode. Major possibility of atrial fibrillation onset after pacemaker implantation should result in more attention during routine ECG examination.

The effect of single engine fixed wing air transport on rate-responsive pacemakers.

PubMed

De Rotte, A A; Van Der Kemp, P

1999-09-01

Insufficient information exists about the safety of patients with accelerometer-based rate-responsive pacemakers in air transport by general aviation aircraft. The response in pacing rate of two types of accelerometer-based rate-responsive pacemakers with data logging capabilities was studied during test flights with single engine fixed wing aircraft. Results were compared with the rate-response of these pacemakers during transportation by car and were also interpreted in respect to physiological heart rate response of aircrew during flights in single engine fixed wing aircraft. In addition, a continuous accelerometer readout was recorded during a turbulent phase of flight. This recording was used for a pacemaker-simulator experiment with maximal sensitive motion-sensor settings. Only a minor increase in pacing rate due to aircraft motion could be demonstrated during all phases of flight at all altitudes with the pacemakers programmed in the normal mode. This increase was of the same magnitude as induced during transport by car and would be of negligible influence on the performance of the individual pacemaker patient equipped with such a pacemaker. Moreover, simultaneous Holter monitoring of the pilots during these flights showed a similar rate-response in natural heart rate compared with the increase in pacing rate induced by aircraft motion in accelerometer-based rate-responsive pacemakers. No sensor-mediated pacemaker tachycardia was seen during any of these recordings. However, a 15% increase in pacing rate was induced by severe air turbulence. Programming the maximal sensitivity of the motion sensor into the pacemaker could, on the other hand, induce a significant increase in pacing rate as was demonstrated by the simulation experiments. These results seem to rule out potentially dangerous or adverse effects from motional or vibrational influences during transport in single engine fixed wing aircraft on accelerometer-based rate-responsive pacemakers with normal activity sensor settings.

Importance of rate control or rate regulation for improving exercise capacity and quality of life in patients with permanent atrial fibrillation and normal left ventricular function: a randomised controlled study

PubMed Central

Levy, T; Walker, S; Mason, M; Spurrell, P; Rex, S; Brant, S; Paul, V

2001-01-01

OBJECTIVE—To determine the importance of rhythm regulation or rate control in patients with permanent atrial fibrillation (AF) and normal left ventricular function.
PATIENTS AND INTERVENTIONS—Thirty six patients with a mixed fast and slow ventricular response rate to their AF were randomised to either His bundle ablation (HBA) and VVIR pacemaker (HBA group) or VVI pacemaker and atrioventricular modifying drugs (Med group). Outcomes assessed at one, three, six, and 12 months included exercise duration and quality of life.
RESULTS—Exercise duration significantly improved from baseline in both groups. There was no difference in outcome between the groups (Med +40% v HBA +20%, p = NS). The heart rate profile on exercise was similarly slowed in both groups compared to baseline. Quality of life significantly improved in both treatment arms for the modified Karolinska questionnaire (KQ) (Med +50% v HBA +50%, p = NS) and the Nottingham health profile (NHP) (Med +40% v HBA +20%, p = NS). However, for the individual symptom scores of each questionnaire more were improved in the Med group (KQ-Med 6 improved v HBA 4, NHP-Med 3 v HBA 1). Left ventricular function was equally preserved by both treatments during follow up.
CONCLUSION—In these patients control of ventricular response rate with either HBA + VVIR pacemaker or atrioventricular modifying drugs + VVI pacemaker will lead to a significant improvement in exercise duration and quality of life. Rhythm regulation by HBA did not confer additional benefit, suggesting rate control alone is necessary for the successful symptomatic treatment of these patients in permanent AF.


Keywords: ablation; atrial fibrillation; pacemaker; atrioventricular modifying drugs PMID:11156667

SU-F-T-654: Pacemaker Dose Estimate Using Optically Stimulated Luminescent Dosimeter for Left Breast Intraoperative Radiation Therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chen, Y; Goenka, A; Sharma, A

Purpose: To assess and report the in vivo dose for a patient with a pacemaker being treated in left breast intraoperative radiation therapy (IORT). The ZEISS Intrabeam 50 kVp X-ray beam with a spherical applicator was used. Methods: The optically stimulated luminescent dosimeters (OSLDs) (Landauer nanoDots) were employed and calibrated under the conditions of the Intrabeam 50 kVp X-rays. The nanoDots were placed on the patient at approximately 15 cm away from the lumpectomy cavity both under and above a shield of lead equivalence 0.25 mm (RayShield X-Drape D-110) covering the pacemaker area during IORT with a 5 cm sphericalmore » applicator. Results: The skin surface dose near the pacemaker during the IORT with a prescription of 20 Gy was measured as 4.0±0.8 cGy. The dose behind the shield was 0.06±0.01 Gy, demonstrating more than 98% dose reduction. The in vivo skin surface doses during a typical breast IORT at a 4.5 cm spherical applicator surface were further measured at 5, 10, 15, and 20 cm away to be 159±11 cGy, 15±1 cGy, 6.6±0.5 cGy, and 1.8±0.1 cGy, respectively. A power law fit to the dose versus the distance z from the applicator surface yields the dose fall off at the skin surface following z^-2.5, which can be used to estimate skin doses in future cases. The comparison to an extrapolation of depth dose in water reveals an underestimate of far field dose using the manufactory provided data. Conclusion: The study suggests the appropriateness of OSLD as an in vivo skin dosimeter in IORT using the Intrabeam system in a wide dose range. The pacemaker dose measured during the left breast IORT was within a safe limit.« less

Self-taught axillary vein access without venography for pacemaker implantation: prospective randomized comparison with the cephalic vein access.

PubMed

Squara, Fabien; Tomi, Julien; Scarlatti, Didier; Theodore, Guillaume; Moceri, Pamela; Ferrari, Emile

2017-12-01

Axillary vein access for pacemaker implantation is uncommon in many centres because of the lack of training in this technique. We assessed whether the introduction of the axillary vein technique was safe and efficient as compared with cephalic vein access, in a centre where no operators had any previous experience in axillary vein puncture. Patients undergoing pacemaker implantation were randomized to axillary or cephalic vein access. All three operators had no experience nor training in axillary vein puncture, and self-learned the technique by reading a published review. Axillary vein puncture was fluoroscopy-guided without contrast venography. Cephalic access was performed by dissection of delto-pectoral groove. Venous access success, venous access duration (from skin incision to guidewire or lead in superior vena cava), procedure duration, X-ray exposure, and peri-procedural (1 month) complications were recorded. results We randomized 74 consecutive patients to axillary (n = 37) or cephalic vein access (n = 37). Axillary vein was successfully accessed in 30/37 (81.1%) patients vs. 28/37 (75.7%) of cephalic veins (P = 0.57). Venous access time was shorter in axillary group than in cephalic group [5.7 (4.4-8.3) vs. 12.2 (10.5-14.8) min, P < 0.001], as well as procedure duration [34.8 (30.6-38.4) vs. 42.0 (39.1-46.6) min, P = 0.043]. X-ray exposure and peri-procedural overall complications were comparable in both groups. Axillary puncture was safe and faster than cephalic access even for the five first procedures performed by each operator. Self-taught axillary vein puncture for pacemaker implantation seems immediately safe and faster than cephalic vein access, when performed by electrophysiologists trained to pacemaker implantation but not to axillary vein puncture. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For Permissions, please email: journals.permissions@oup.com.

Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions.

PubMed

Bailey, William M; Rosenthal, Lawrence; Fananapazir, Lameh; Gleva, Marye; Mazur, Alexander; Rinaldi, C A; Kypta, Alexander; Merkely, Béla; Woodard, Pamela K

2015-06-01

Permanent cardiac pacemakers have historically been considered a contraindication to magnetic resonance imaging (MRI). The purpose of the ProMRI/ProMRI AFFIRM Study, which was a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI Pacemaker System under specific MRI conditions. The ProMRI Study (in the United States) and the ProMRI AFFIRM study (outside the United States) with identical design enrolled 272 patients with stable baseline pacing indices implanted with an Entovis or Evia pacemaker (DR-T or SR-T) and Setrox or Safio 53-cm or 60-cm lead. Device interrogation was performed at enrollment, pre-MRI and post-MRI scan, and 1 and 3 months post-MRI. End-points were (1) freedom from MRI- and pacing system-related serious adverse device effects (SADEs) through 1 month post-MRI, (2) freedom from atrial and ventricular MRI-induced pacing threshold increase (>0.5 V), and (3) freedom from P- and R-wave amplitude attenuation (<50%), or P wave <1.5 mV, or R wave <5.0 mV at 1 month post-MRI. Two hundred twenty-six patients completed the MRI and 1-month post-MRI follow-up. No adverse events related to the implanted system and the MRI procedure occurred, resulting in an SADE-free rate of 100.0% (229/229, P <.001). Freedom from atrial and ventricular pacing threshold increase was 99.0% (189/191, P = .003) and 100% (217/217, P <.001), respectively. Freedom from P- and R- wave amplitude attenuation was 99.4% (167/168, P <.001) and 99.5% (193/194, P <.001), respectively. The results of the ProMRI/ProMRI AFFIRM studies demonstrate the clinical safety and efficacy of the ProMRI pacemaker system in patients subjected to head and lower lumbar MRI conditions. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Case-control study of surgical site infections associated with pacemakers and implantable cardioverter-defibrillators.

PubMed

Marschall, Jonas; Hopkins-Broyles, Diane; Jones, Marilyn; Fraser, Victoria J; Warren, David K

2007-11-01

In 2000, the rate of surgical site infections (SSIs) associated with pacemaker and implantable cardioverter-defibrillator (ICD) procedures performed in the cardiothoracic operating rooms of hospital A was 16% (19 of 116 procedures resulted in infections). This study investigates risks for SSI associated with these procedures in the cardiothoracic operating room. Unmatched 1 : 3 case-control study performed over a 12-month period among patients who had undergone implantation of a pacemaker and/or ICD. A standardized observation scrutinized infection control practices in the area where the procedures were performed. The cardiothoracic operating rooms of hospital A, which belongs to a hospital consortium in the midwestern United States. Patients with SSI were identified as case patients. Control patients were chosen from the group of uninfected patients who had procedures performed during the same period as case patients. A total of 19 SSIs associated with pacemaker and ICD procedures were retrospectively identified among the patients who underwent procedures in these cardiothoracic operating rooms. Culture samples were obtained from 7 patients; 2 yielded coagulase-negative Staphylococcus on culture, 2 yielded Staphylococcus aureus, 1 yielded Serratia marcescens, and 2 showed no growth. In the case-control study, age, race, sex, diabetes mellitus, smoking history, timing of antibiotic therapy, and hair removal did not differ significantly between case patients and control patients. Case patients were more likely to have an abdominal device in place (odds ratio [OR], 5.5 [95% confidence interval {CI}, 1.6-19.3]; P=.006) and less likely to have received a new implant (OR 0.3 [95% CI, 0.1-0.8]; P=.02) or to have had new leads placed (OR, 0.2 [95% CI, 0.1-0.6]; P=.003). Abdominal placement of implanted devices was associated with occurrence of an SSI after pacemaker and/or ICD procedures.

The interference of electronic implants in low frequency electromagnetic fields.

PubMed

Silny, J

2003-04-01

Electronic implants such as cardiac pacemakers or nerve stimulators can be impaired in different ways by amplitude-modulated and even continuous electric or magnetic fields of strong field intensities. For the implant bearer, possible consequences of a temporary electromagnetic interference may range from a harmless impairment of his well-being to a perilous predicament. Electromagnetic interferences in all types of implants cannot be covered here due to their various locations in the body and their different sensing systems. Therefore, this presentation focuses exemplarily on the most frequently used implant, the cardiac pacemaker. In case of an electromagnetic interference the cardiac pacemaker reacts by switching to inhibition mode or to fast asynchronous pacing. At a higher disturbance voltage on the input of the pacemaker, a regular asynchronous pacing is likely to arise. In particular, the first-named interference could be highly dangerous for the pacemaker patient. The interference threshold of cardiac pacemakers depends in a complex way on a number of different factors such as: electromagnetic immunity and adjustment of the pacemaker, the composition of the applied low-frequency fields (only electric or magnetic fields or combinations of both), their frequencies and modulations, the type of pacemaker system (bipolar, unipolar) and its location in the body, as well as the body size and orientation in the field, and last but not least, certain physiological conditions of the patient (e.g. inhalation, exhalation). In extensive laboratory studies we have investigated the interference mechanisms in more than 100 cardiac pacemakers (older types as well as current models) and the resulting worst-case conditions for pacemaker patients in low-frequency electric and magnetic fields. The verification of these results in different practical everyday-life situations, e.g. in the fields of high-voltage overhead lines or those of electronic article surveillance systems is currently in progress. In case of the vertically-oriented electric 50 Hz fields preliminary results show that per 1 kV/m unimpaired electrical field strength (rms) an interference voltage of about 400 microVpp as worst-case could occur at the input of a unipolar ventricularly controlled, left-pectorally implanted cardiac pacemaker. Thus, already a field strength above ca. 5 kV/m could cause an interference with an implanted pacemaker. The magnetic fields induces an electric disturbance voltage at the input of the pacemaker. The body and the pacemaker system compose several induction loops, whose induced voltages rates add or subtract. The effective area of one representing inductive loop ranges from 100 to 221 cm2. For the unfavourable left-pectorally implantated and atrially-controlled pacemaker with a low interference threshold, the interference threshold ranges between 552 and 16 microT (rms) for magnetic fields at frequencies between 10 and 250 Hz. On this basis the occurrence of interferences with implanted pacemakers is possible in everyday-life situations. But experiments demonstrate a low probability of interference of cardiac pacemakers in practical situations. This apparent contradiction can be explained by a very small band of inhibition in most pacemakers and, in comparison with the worst-case, deviating conditions.

Percutaneous Transvenous Mitral Annuloplasty (PTMA) with the Viking device reduces pacing-induced mitral regurgitation.

PubMed

Kimblad, Per Ola; Harnek, Jan; Roijer, Anders; Meurling, Carl; Brandt, Johan; Solem, Jan Otto

2005-11-01

The new percutaneous mitral annuloplasty Viking device was evaluated in surviving sheep with pacing-induced mitral regurgitation. Twenty sheep were subjected to rapid ventricular pacing for one to three months, leading to cardiomyopathy and mitral regurgitation. Device implantation could be successfully performed in 11 of these animals after pacemaker treatment for 64+/-7 days. The device-related procedure time was 12+/-2 min. The mean follow-up time was 58+/-8 days after implantation of the device. Mitral annulus septo-lateral diameter was significantly reduced after insertion of the device, from 35+/-1 mm before implantation to 30+/-1 mm at the final follow up intracardiac echocardiography (P = 0.0097). The degree of mitral regurgitation (on a scale from 0 to 4) was 2.6+/-0.2 before device implantation and decreased to 0.8+/-0.2 after treatment (P = 0.0039), and the vena contracta was reduced from 7+/-0.4 mm to 3+/-0.8 mm (P = 0.0019). Angiography showed no signs of impairment of the coronary arteries. No thrombosis was observed. These results indicate that the septo-lateral diameter of the mitral annulus, and the degree of experimentally induced mitral regurgitation, can be significantly reduced with a percutaneous catheter technique in surviving sheep.

Digital music players cause interference with interrogation telemetry for pacemakers and implantable cardioverter-defibrillators without affecting device function.

PubMed

Webster, Gregory; Jordao, Ligia; Martuscello, Maria; Mahajan, Tarun; Alexander, Mark E; Cecchin, Frank; Triedman, John K; Walsh, Edward P; Berul, Charles I

2008-04-01

Concern exists regarding the potential electromagnetic interaction between pacemakers, implantable cardioverter-defibrillators (ICDs) and digital music players (DMPs). A preliminary study reported interference in 50% of patients whose devices were interrogated near Apple iPods. Given the high prevalence of DMP use among young patients, we sought to define the nature of interference from iPods and evaluate other DMPs. Four DMPs (Apple Nano, Apple Video, SanDisk Sansa and Microsoft Zune) were evaluated against pacemakers and ICDs (PM/ICD). Along with continuous monitoring, we recorded a baseline ECG strip, sensing parameters and lead impedance at baseline and for each device. Among 51 patients evaluated (age 6 to 60 years, median 22), there was no interference with intrinsic device function. Interference with the programmer occurred in 41% of the patients. All four DMPs caused programmer interference, including disabled communication between the PM/ICD and programmer, noise in the ECG channel, and lost marker channel indicators. Sensing parameters and lead impedances exhibited no more than baseline variability. When the DMPs were removed six inches, there were no further programmer telemetry interactions. Contrary to a prior report, we did not identify any evidence for electromagnetic interference between a selection of DMPs and intrinsic function of PM/ICDs. The DMPs did sometimes interfere with device-programmer communication, but not in a way that compromised device function. Therefore, we recommend that DMPs not be used during device interrogation, but suggest that there is reassuring counterevidence to mitigate the current high level of concern for interactions between DMPs and implantable cardiac rhythm devices.

Electromagnetic interference with cardiac pacemakers and implantable cardioverter-defibrillators from low-frequency electromagnetic fields in vivo.

PubMed

Tiikkaja, Maria; Aro, Aapo L; Alanko, Tommi; Lindholm, Harri; Sistonen, Heli; Hartikainen, Juha E K; Toivonen, Lauri; Juutilainen, Jukka; Hietanen, Maila

2013-03-01

Electromagnetic interference (EMI) can pose a danger to workers with pacemakers and implantable cardioverter-defibrillators (ICDs). At some workplaces electromagnetic fields are high enough to potentially inflict EMI. The purpose of this in vivo study was to evaluate the susceptibility of pacemakers and ICDs to external electromagnetic fields. Eleven volunteers with a pacemaker and 13 with an ICD were exposed to sine, pulse, ramp, and square waveform magnetic fields with frequencies of 2-200 Hz using Helmholtz coil. The magnetic field flux densities varied to 300 µT. We also tested the occurrence of EMI from an electronic article surveillance (EAS) gate, an induction cooktop, and a metal inert gas (MIG) welding machine. All pacemakers were tested with bipolar settings and three of them also with unipolar sensing configurations. None of the bipolar pacemakers or ICDs tested experienced interference in any of the exposure situations. The three pacemakers with unipolar settings were affected by the highest fields of the Helmholtz coil, and one of them also by the EAS gate and the welding cable. The induction cooktop did not interfere with any of the unipolarly programmed pacemakers. Magnetic fields with intensities as high as those used in this study are rare even in industrial working environments. In most cases, employees can return to work after implantation of a bipolar pacemaker or an ICD, after an appropriate risk assessment. Pacemakers programmed to unipolar configurations can cause danger to their users in environments with high electromagnetic fields, and should be avoided, if possible.

Pacemaker diagnostics in atrial fibrillation: limited usefulness for therapy initiation in a pacemaker practice.

PubMed

Yedlapati, Neeraja; Fisher, John D

2014-09-01

We aimed to determine the practical value of pacemaker diagnostics for atrial fibrillation (AF) in an unselected general pacemaker practice, specifically workflow and initiation of anticoagulation or antiarrhythmic drug (AAD) therapy. We prospectively followed consecutive pacemaker interrogations over a period of 1 year to identify patients with AF (burden from 1% to 99%). We contacted referring physicians with AF details, and then determined whether the information resulted in therapeutic changes. Of the 1,100 pacemakers interrogated, 728 were dual chamber (DDDs) with AF diagnostic capability. AF was recorded in 73 (10%) but seven had limited information, leaving 66 patients; of these, 42 (63%) patients were already anticoagulated and in five (7%) patients, anticoagulation had been stopped because of complications. Initial diagnosis of AF was made by the pacemaker in 17 patients (26% of 66; 2% of 728); four (6% of 66) patients were newly initiated on anticoagulation. Of the 66 patients, 17 patients were already on AADs; 49 (74%) had satisfactory rate control or had other issues; only two (3% of 66; 0.3% of 728) received new AADs. Of 728 patients with DDD pacemakers, only 17 were newly discovered to have AF, and six (0.8%) had changes in medications based on the pacemaker data. Adding pacemaker-derived data to existing clinical information had little therapeutic impact, due to a combination of cumbersome workflow, and because AF was usually known to practitioners. Developments in automated monitoring systems may provide more accessible and therapeutically useful information. ©2014 Wiley Periodicals, Inc.

Implantable defibrillators configured for hybrid therapy of persistent and permanent atrial fibrillation: initial clinical experience with a novel lead system.

PubMed

Rao, Hygriv B; Saksena, Sanjeev

2005-08-01

Hybrid therapy strategies have combined antiarrhythmic drugs (AAD) with pacemakers, atrio-ventricular defibrillators (AV ICD) or atrial ablation individually. The feasibility combining AAD with dual site RA pacing (DAP) in an AV ICD has not been examined. We used an AV ICD with a novel lead configuration permitting DAP, antitachycardia pacing (ATP) or atrial shocks (ADF) in patients (pts) with refractory persistent or permanent AF. Hybrid therapy included linear RA ablation and/or focal ablation. Continuous DAP and automatic ATP with patient or physician activated ADF. 24 pts, mean age 66 +/- 10 yrs, with cardiac disease (22 pts), underwent insertion of an AVICD with dual RA leads. 20 patients had concomitant ablative procedures (RA only = 19, RA + LA = 1) and all pts continued previously ineffective AAD. During a follow-up of 2-36 months (mean 17 +/- 8 mos), rhythm control was restored in all pts & maintained long-term in 19 (83%) pts. 8 pts used AF termination therapies successfully. Device datalogs showed no episodes of AF in 6 pts, asymptomatic brief arrhythmias in 4 pts, infrequent paroxysmal AF in 9 pts & persistent AF recurred in 5 pts. AV ICD detection algorithms reliably detected AF or AT in the DAP mode in all pts. Intermittent brief P wave double counting occurred during AT in selected pts. No pt received inappropriate ADF therapy. 1. DAP can be safely incorporated in an AVICD devices for use in an hybrid therapy strategy for AF pts. 2. These devices can be effective for both AF prevention & termination. 3. Long term rhythm control can be achieved and documented by device datalogs in persistent and permanent AF.

Electrocardiographic Predictors of Long-Term Cardiac Pacing Dependency Following Transcatheter Aortic Valve Implantation.

PubMed

Naveh, Sivan; Perlman, Gidon Y; Elitsur, Yair; Planer, David; Gilon, Dan; Leibowitz, David; Lotan, Chaim; Danenberg, Haim; Alcalai, Ronny

2017-02-01

Conduction disorders requiring permanent pacemaker (PPM) implantation are a known complication of transcatheter aortic valve implantation (TAVI). Indications for permanent pacing in this setting are still controversial. The study aim was to characterize the natural history of conduction disorders related to TAVI, and to identify predictors for long-term pacing dependency. Consecutive patients who underwent TAVI were included in this prospective observational study. The conduction system was investigated by reviewing 12-lead ECGs during hospitalization and up to 1-year follow-up and by analyzing pacemaker interrogation data. Multivariate analysis was performed in order to identify independent predictors for pacemaker dependency. Of 110 patients included in the analysis, 38 (34.5%) underwent PPM implantation. Of those, 26 (68.4%) had a long-term pacing dependency (required PPM), while 12 (31.6%) did not (not-required PPM). Logistic regression revealed that baseline RBBB (P = 0.01, OR = 18.0), baseline PR interval (P = 0.019, OR = 1.14), post-TAVI PR interval and the change in PR interval from baseline (P < 0.001 for both, OR = 1.17 for each 10 milliseconds increment) were independent predictors for long-term pacing dependency. A PR interval increment of greater than 28 milliseconds had the best accuracy in predicting pacemaker dependency. Increased pre- and postprocedural PR intervals and pre-existing RBBB are reliable predictors for long-term PPM dependency, while left bundle branch block or QRS width are misleading factors. Our study suggests that the decision for implanting PPM after TAVI should be based mostly on the prolongation of the PR interval. © 2016 Wiley Periodicals, Inc.

The retrospectroscope-the invention of the rechargeable cardiac pacemaker: vignette #9.

PubMed

Fischell, R E

1990-01-01

The idea for a rechargeable cardiac pacemaker came to the author in the late 1960s after reading an advertisement stating that a company's batteries were so good they would last two years in a heart pacemaker. This meant that pacemaker patients would have to undergo surgery for their replacement frequently. Having worked on the development of hermetically sealed, nickel-cadmium batteries that could function for a decade or longer in an orbiting spacecraft, the author constructed the first prototype of a rechargeable cardiac pacemaker around 1968 to show cardiologists at Johns Hopkins Hospital that a pacemaker of indefinitely long life and much smaller size and weight could be built readily. The subsequent development and marketing of the device, which came on the market in 1973, is recounted.

Anodal right ventricular capture during left ventricular stimulation in CRT-implantable cardioverter defibrillators.

PubMed

Thibault, Bernard; Roy, Denis; Guerra, Peter G; Macle, Laurent; Dubuc, Marc; Gagné, Pierre; Greiss, Isabelle; Novak, Paul; Furlani, Aldo; Talajic, Mario

2005-07-01

Cardiac resynchronization therapy (CRT) has been shown to improve symptoms of patients with moderate to severe heart failure. Optimal CRT involves biventricular or left ventricular (LV) stimulation alone, atrio-ventricular (AV) delay optimization, and possibly interventricular timing adjustment. Recently, anodal capture of the right ventricle (RV) has been described for patients with CRT-pacemakers. It is unknown whether the same phenomenon exists in CRT systems associated with defibrillators (CRT-ICD). The RV leads used in these systems are different from pacemaker leads: they have a larger diameter and shocking coils, which may affect the occurrence of anodal capture. We looked for anodal RV capture during LV stimulation in 11 consecutive patients who received a CRT-ICD system with RV leads with a true bipolar design. Fifteen patients who had RV leads with an integrated design were used as controls. Anodal RV and LV thresholds were determined at pulse width (pw) durations of 0.2, 0.5, and 1.0 ms. RV anodal capture during LV pacing was found in 11/11 patients at some output with true bipolar RV leads versus 0/15 patients with RV leads with an integrated bipolar design. Anodal RV capture threshold was more affected by changes in pw duration than LV capture threshold. In CRT-ICD systems, RV leads with a true bipolar design with the proximal ring also used as the anode for LV pacing are associated with a high incidence of anodal RV capture during LV pacing. This may affect the clinical response to alternative resynchronization methods using single LV stimulation or interventricular delay programming.

The effects of nuclear magnetic resonance on patients with cardiac pacemakers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pavlicek, W.; Geisinger, M.; Castle, L.

1983-04-01

The effect of nuclear magnetic resonance (NMR) imaging on six representative cardiac pacemakers was studied. The results indicate that the threshold for initiating the asynchronous mode of a pacemaker is 17 gauss. Radiofrequency levels are present in an NMR unit and may confuse or possibly inhibit demand pacemakers, although sensing circuitry is normally provided with electromagnetic interference discrimination. Time-varying magnetic fields can generate pulse amplitudes and frequencies to mimic cardiac activity. A serious limitation in the possibility of imaging a patient with a pacemaker would be the alteration of normal pulsing parameters due to time-varying magnetic fields.

21 CFR Appendix B to Subpart B of... - Scope of Product Coverage

Code of Federal Regulations, 2013 CFR

2013-04-01

... Portable air compressor 2 Cardiovascular Panel Cardiovascular Diagnostic 870.1425 Programmable diagnostic... Pacemaker & Accessories 870.1750 External programmable pacemaker pulse generator 2 870.3630 Pacemaker...

21 CFR Appendix B to Subpart B of... - Scope of Product Coverage

Code of Federal Regulations, 2014 CFR

2014-04-01

... Portable air compressor 2 Cardiovascular Panel Cardiovascular Diagnostic 870.1425 Programmable diagnostic... Pacemaker & Accessories 870.1750 External programmable pacemaker pulse generator 2 870.3630 Pacemaker...

21 CFR Appendix B to Subpart B of... - Scope of Product Coverage

Code of Federal Regulations, 2012 CFR

2012-04-01

... Portable air compressor 2 Cardiovascular Panel Cardiovascular Diagnostic 870.1425 Programmable diagnostic... Pacemaker & Accessories 870.1750 External programmable pacemaker pulse generator 2 870.3630 Pacemaker...

Devices for Arrhythmia

MedlinePlus

... with recurrent arrhythmias, medical devices such as a pacemaker and implantable cardioverter defibrillator (ICD) can help by ... with an ICD Questions to ask your doctor Pacemakers Learn what an artificial pacemaker is, how it ...

Heart pacemaker

MedlinePlus

... please enable JavaScript. A pacemaker is a small, battery-operated device. This device senses when your heart ... pacemakers have 2 parts: The generator contains the battery and the information to control the heartbeat. The ...

Inadvertent defibrillator lead placement into the left ventricle after MitraClip implantation: A case report.

PubMed

Santarpia, Giuseppe; Passafaro, Francesco; Pasceri, Eugenia; Mongiardo, Annalisa; Curcio, Antonio; Indolfi, Ciro

2018-05-01

Inadvertent pacemaker/defibrillator lead placement into the left ventricle is an unusual cardiac device-related complication and its diagnosis is not always easy and often misunderstood. Thromboembolic events are frequently associated with this procedural complication. Percutaneous lead extraction should be performed when diagnosis is made early after device implantation while long-life oral anticoagulation is a wise option when the diagnosis is delayed and the lead is not removed. A 65-year-old man affected by dilated cardiomyopathy, previously treated with a percutaneous mitral valve repair, with 2 MitraClip devices, and later with dual chamber cardioverter/defibrillator implantation, returned in outpatient clinics 2 months after discharge for deterioration of dyspnea; transthoracic echocardiography revealed that the shock lead had been accidentally placed in the apex of the left ventricle. The unintentional lead malposition through the iatrogenic atrial septal defect and its presence into the mitral valve orifice, together with the 2 clip devices implanted, generated an acceleration of transvalvular diastolic flow, determining a moderate stenosis of the mitral valve, as well as promoting a worsening of the degree of valvular regurgitation. Oral anticoagulation therapy was started and a mechanical lead extraction was percutaneously performed. A new defibrillator lead was later appropriately positioned in the apex of the right ventricle. The patient was discharged 3 days after intervention and the follow-up, performed 1 month after discharge, was uneventful. Complex interventional procedures and implantation of multiple devices can increase procedural troubles and the risk of mechanical complications related to pacemaker/defibrillator implantation. Careful observation of the QRS complex morphology on the electrocardiogram (ECG), during paced rhythm, and the achievement of the echocardiographic examination, in the postprocedural phase, allow an early diagnosis of lead malposition.

The usefulness of a stretch-polyester pouch to encase implanted pacemakers and defibrillators.

PubMed

Parsonnet, V; Bernstein, A D; Neglia, D; Omar, A

1994-12-01

This study was undertaken to assess the effects of enclosing permanent pacemaker and ICD pulse generators in a stretch-polyester pouch prior to implantation. Follow-up of 223 patients with oversized pacemakers and with ICDs and 344 with standard-sized pacemaker pulse generators showed that the pouch was effective in decreasing the frequency of pulse generator migration and extrusion.

Deterioration of autonomic neuronal receptor signaling and mechanisms intrinsic to heart pacemaker cells contribute to age-associated alterations in heart rate variability in vivo.

PubMed

Yaniv, Yael; Ahmet, Ismayil; Tsutsui, Kenta; Behar, Joachim; Moen, Jack M; Okamoto, Yosuke; Guiriba, Toni-Rose; Liu, Jie; Bychkov, Rostislav; Lakatta, Edward G

2016-08-01

We aimed to determine how age-associated changes in mechanisms extrinsic and intrinsic to pacemaker cells relate to basal beating interval variability (BIV) reduction in vivo. Beating intervals (BIs) were measured in aged (23-25 months) and adult (3-4 months) C57BL/6 male mice (i) via ECG in vivo during light anesthesia in the basal state, or in the presence of 0.5 mg mL(-1) atropine + 1 mg mL(-1) propranolol (in vivo intrinsic conditions), and (ii) via a surface electrogram, in intact isolated pacemaker tissue. BIV was quantified in both time and frequency domains using linear and nonlinear indices. Although the average basal BI did not significantly change with age under intrinsic conditions in vivo and in the intact isolated pacemaker tissue, the average BI was prolonged in advanced age. In vivo basal BIV indices were found to be reduced with age, but this reduction diminished in the intrinsic state. However, in pacemaker tissue BIV indices increased in advanced age vs. adults. In the isolated pacemaker tissue, the sensitivity of the average BI and BIV in response to autonomic receptor stimulation or activation of mechanisms intrinsic to pacemaker cells by broad-spectrum phosphodiesterase inhibition declined in advanced age. Thus, changes in mechanisms intrinsic to pacemaker cells increase the average BIs and BIV in the mice of advanced age. Autonomic neural input to pacemaker tissue compensates for failure of molecular intrinsic mechanisms to preserve average BI. But this compensation reduces the BIV due to both the imbalance of autonomic neural input to the pacemaker cells and altered pacemaker cell responses to neural input. © 2016 The Authors. Aging Cell published by the Anatomical Society and John Wiley & Sons Ltd.

Right bundle branch block pattern during right ventricular permanent pacing: Is it safe or not?

PubMed Central

Erdogan, Okan; Aksu, Feyza

2007-01-01

The present case report describes a patient with dual chamber pacemaker whose surface ECG demonstrated paced right bundle branch block pattern suggesting a malpositioned ventricular lead in the left ventricle. However, diagnostic work-up revealed that the lead was appropriately located in the right ventricular apex. Diagnostic maneuvers and clues for differentiating safe right bundle branch block pattern during permanent pacing are thoroughly revisited and discussed within the article. PMID:17684578

Risk Factors For Bradycardia Requiring Pacemaker Implantation In Patients With Atrial Fibrillation

PubMed Central

Barrett, Tyler W.; Abraham, Robert L.; Jenkins, Cathy A.; Russ, Stephan; Storrow, Alan B.; Darbar, Dawood

2012-01-01

Symptomatic bradycardia may complicate atrial fibrillation (AF) and necessitate a permanent pacemaker. Identifying patients at increased risk for symptomatic bradycardia may reduce associated morbidities and healthcare costs. We investigated predictors for developing bradycardia requiring a permanent pacemaker among AF patients. We reviewed records of all patients treated for AF/flutter in an academic hospital’s emergency department from 8/1/2005 to 8/30/2008. We determined survival and presence of a pacemaker as of 11/1/2011. Cases were defined as patients with pacemakers placed for bradycardia after their AF diagnoses. Patients without a pacemaker who were followed at our hospital comprised the controls. We identified a priori variables for the logistic regression analysis. We fit a post-hoc model adjusting for AF type and atrioventricular nodal blocker (AVN) use. Of the 362 patients in our cohort, 119 cases had permanent pacemakers implanted for bradycardia subsequent to AF diagnosis and 243 controls were alive without a pacemaker. Median and interquartile range follow-up time was 4.5 (3.8 – 5.4) years. Odds ratios and 95% confidence intervals were determined for age at time of AF diagnosis (1.02 [1, 1.04]), female (1.58 [0.95, 2.63]), prior heart failure (2.72 [1.47, 5.01]), and African-American (0.33 [0.12, 0.94]). Post-hoc model identified permanent AF (2.99 [1.61, 5.57]) and AVN use (1.43 [0.85, 2.4]). In conclusion, among AF patients, heart failure and permanent AF each nearly triple the odds of developing bradycardia requiring a permanent pacemaker; while not statistically significant, our results suggest that women are more likely and African-Americans less likely to develop bradycardia requiring pacemaker implantation. PMID:22840846

Effects of pine needle extract on pacemaker currents in interstitial cells of Cajal from the murine small intestine.

PubMed

Cheong, Hyeonsook; Paudyal, Dilli Parasad; Jun, Jae Yeoul; Yeum, Cheol Ho; Yoon, Pyung Jin; Park, Chan Guk; Kim, Man Yoo; So, Insuk; Kim, Ki Whan; Choi, Seok

2005-10-31

Extracts of pine needles (Pinus densiflora Sieb. et Zucc.) have diverse physiological and pharmacological actions. In this study we show that pine needle extract alters pacemaker currents in interstitial cells of Cajal (ICC) by modulating ATP-sensitive K+ channels and that this effect is mediated by prostaglandins. In whole cell patches at 30 degrees , ICC generated spontaneous pacemaker potentials in the current clamp mode (I = 0), and inward currents (pacemaker currents) in the voltage clamp mode at a holding potential of -70 mV. Pine needle extract hyperpolarized the membrane potential, and in voltage clamp mode decreased both the frequency and amplitude of the pacemaker currents, and increased the resting currents in the outward direction. It also inhibited the pacemaker currents in a dose-dependent manner. Because the effects of pine needle extract on pacemaker currents were the same as those of pinacidil (an ATP-sensitive K+ channel opener) we tested the effect of glibenclamide (an ATP-sensitive K+ channels blocker) on ICC exposed to pine needle extract. The effects of pine needle extract on pacemaker currents were blocked by glibenclamide. To see whether production of prostaglandins (PGs) is involved in the inhibitory effect of pine needle extract on pacemaker currents, we tested the effects of naproxen, a non-selective cyclooxygenase (COX-1 and COX-2) inhibitor, and AH6809, a prostaglandin EP1 and EP2 receptor antagonist. Naproxen and AH6809 blocked the inhibitory effects of pine needle extract on ICC. These results indicate that pine needle extract inhibits the pacemaker currents of ICC by activating ATP-sensitive K+ channels via the production of PGs.

Zebrafish heart as a model to study the integrative autonomic control of pacemaker function

PubMed Central

Stoyek, Matthew R.; Quinn, T. Alexander; Croll, Roger P.

2016-01-01

The cardiac pacemaker sets the heart's primary rate, with pacemaker discharge controlled by the autonomic nervous system through intracardiac ganglia. A fundamental issue in understanding the relationship between neural activity and cardiac chronotropy is the identification of neuronal populations that control pacemaker cells. To date, most studies of neurocardiac control have been done in mammalian species, where neurons are embedded in and distributed throughout the heart, so they are largely inaccessible for whole-organ, integrative studies. Here, we establish the isolated, innervated zebrafish heart as a novel alternative model for studies of autonomic control of heart rate. Stimulation of individual cardiac vagosympathetic nerve trunks evoked bradycardia (parasympathetic activation) and tachycardia (sympathetic activation). Simultaneous stimulation of both vagosympathetic nerve trunks evoked a summative effect. Effects of nerve stimulation were mimicked by direct application of cholinergic and adrenergic agents. Optical mapping of electrical activity confirmed the sinoatrial region as the site of origin of normal pacemaker activity and identified a secondary pacemaker in the atrioventricular region. Strong vagosympathetic nerve stimulation resulted in a shift in the origin of initial excitation from the sinoatrial pacemaker to the atrioventricular pacemaker. Putative pacemaker cells in the sinoatrial and atrioventricular regions expressed adrenergic β2 and cholinergic muscarinic type 2 receptors. Collectively, we have demonstrated that the zebrafish heart contains the accepted hallmarks of vertebrate cardiac control, establishing this preparation as a viable model for studies of integrative physiological control of cardiac function by intracardiac neurons. PMID:27342878

Use of an Atrial Lead with Very Short Tip-To-Ring Spacing Avoids Oversensing of Far-Field R-Wave

PubMed Central

Kolb, Christof; Nölker, Georg; Lennerz, Carsten; Jetter, Hansmartin; Semmler, Verena; Pürner, Klaus; Gutleben, Klaus-Jürgen; Reents, Tilko; Lang, Klaus; Lotze, Ulrich

2012-01-01

Objective The AVOID-FFS (Avoidance of Far-Field R-wave Sensing) study aimed to investigate whether an atrial lead with a very short tip-to-ring spacing without optimization of pacemaker settings shows equally low incidence of far-field R-wave sensing (FFS) when compared to a conventional atrial lead in combination with optimization of the programming. Methods Patients receiving a dual chamber pacemaker were randomly assigned to receive an atrial lead with a tip-to-ring spacing of 1.1 mm or a lead with a conventional tip-to-ring spacing of 10 mm. Postventricular atrial blanking (PVAB) was programmed to the shortest possible value of 60 ms in the study group, and to an individually determined optimized value in the control group. Atrial sensing threshold was programmed to 0.3 mV in both groups. False positive mode switch caused by FFS was evaluated at one and three months post implantation. Results A total of 204 patients (121 male; age 73±10 years) were included in the study. False positive mode switch caused by FFS was detected in one (1%) patient of the study group and two (2%) patients of the control group (p = 0.62). Conclusion The use of an atrial electrode with a very short tip-to-ring spacing avoids inappropriate mode switch caused by FFS without the need for individual PVAB optimization. Trial Registration ClinicalTrials.gov NCT00512915 PMID:22745661

Use of an atrial lead with very short tip-to-ring spacing avoids oversensing of far-field R-wave.

PubMed

Kolb, Christof; Nölker, Georg; Lennerz, Carsten; Jetter, Hansmartin; Semmler, Verena; Pürner, Klaus; Gutleben, Klaus-Jürgen; Reents, Tilko; Lang, Klaus; Lotze, Ulrich

2012-01-01

The AVOID-FFS (Avoidance of Far-Field R-wave Sensing) study aimed to investigate whether an atrial lead with a very short tip-to-ring spacing without optimization of pacemaker settings shows equally low incidence of far-field R-wave sensing (FFS) when compared to a conventional atrial lead in combination with optimization of the programming. Patients receiving a dual chamber pacemaker were randomly assigned to receive an atrial lead with a tip-to-ring spacing of 1.1 mm or a lead with a conventional tip-to-ring spacing of 10 mm. Postventricular atrial blanking (PVAB) was programmed to the shortest possible value of 60 ms in the study group, and to an individually determined optimized value in the control group. Atrial sensing threshold was programmed to 0.3 mV in both groups. False positive mode switch caused by FFS was evaluated at one and three months post implantation. A total of 204 patients (121 male; age 73±10 years) were included in the study. False positive mode switch caused by FFS was detected in one (1%) patient of the study group and two (2%) patients of the control group (p = 0.62). The use of an atrial electrode with a very short tip-to-ring spacing avoids inappropriate mode switch caused by FFS without the need for individual PVAB optimization. ClinicalTrials.gov NCT00512915.

Reticulated telangiectatic erythema of the pacemaker.

PubMed

Martin, Lucy K; Wendschuh, Philip; Wendschuh, Peter

2008-05-01

Reticulated telangiectatic erythema is a rare entity; it has been reported to occur following the placement of implanted cardiac devices and drug delivery systems. Histologically, reticulated telangiectatic erythema of the pacemaker is characterized by slight spongiosis and increased dermal telangiectasias. We describe a patient that developed reticulated telangiectatic nonpruritic patches on the left chest after the placement of a pacemaker. The patient responded favorably to the removal of the pacemaker.

Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience.

PubMed

Reddy, Vivek Y; Miller, Marc A; Knops, Reinoud E; Neuzil, Petr; Defaye, Pascal; Jung, Werner; Doshi, Rahul; Castellani, Mark; Strickberger, Adam; Mead, R Hardwin; Doppalapudi, Harish; Lakkireddy, Dhanunjaya; Bennett, Matthew; Sperzel, Johannes

2016-12-01

Leadless cardiac pacemakers have emerged as a safe and effective alternative to conventional transvenous single-chamber ventricular pacemakers. Herein, we report a multicenter experience on the feasibility and safety of acute retrieval (<6 weeks) and chronic retrieval (>6 weeks) of the leadless cardiac pacemaker in humans. This study included patients enrolled in 3 multicenter trials, who received a leadless cardiac pacemaker implant and who subsequently underwent a device removal attempt. The overall leadless pacemaker retrieval success rate was 94%: for patients whose leadless cardiac pacemaker had been implanted for <6 weeks (acute retrieval cohort), complete retrieval was achieved in 100% (n=5/5); for those implanted for ≥ 6 weeks (chronic retrieval cohort), retrieval was achieved in 91% (n=10/11) of patients. The mean duration of time from implant to retrieval attempt was 346 days (range, 88-1188 days) in the chronic retrieval cohort, and nearly two thirds (n=7; 63%) had been implanted for >6 months before the retrieval attempt. There were no procedure-related adverse events at 30 days post retrieval procedure. This multicenter experience demonstrated the feasibility and safety of retrieving a chronically implanted single-chamber (right ventricle) active fixation leadless pacemaker. URL: https://www.clinicaltrials.gov. Unique identifiers: NCT02051972, NCT02030418, and NCT01700244. © 2016 American Heart Association, Inc.

Influence of digital and analogue cellular telephones on implanted pacemakers.

PubMed

Altamura, G; Toscano, S; Gentilucci, G; Ammirati, F; Castro, A; Pandozi, C; Santini, M

1997-10-01

The aim of this study was to find out whether digital and analogue cellular 'phones affect patients with pacemakers. The study comprised continuous ECG monitoring of 200 pacemaker patients. During the monitoring certain conditions caused by interference created by the telephone were looked for: temporary or prolonged pacemaker inhibition; a shift to asynchronous mode caused by electromagnetic interference; an increase in ventricular pacing in dual chamber pacemakers, up to the programmed upper rate. The Global System for Mobile Communications system interfered with pacing 97 times in 43 patients (21.5%). During tests on Total Access of Communication System telephones, there were 60 cases of pacing interference in 35 patients (17.5%). There were 131 interference episodes during ringing vs 26 during the on/off phase; (P < 0.0001); 106 at maximum sensitivity level vs 51 at the 'base' value; P < 0.0001). Prolonged pacing inhibition (> 4 s) was seen at the pacemaker 'base' sensing value in six patients using the Global system but in only one patient using Total Access. Cellular 'phones may be dangerous for pacemaker patients. However, they can be used safely if patients do not carry the 'phone close to the pacemaker, which is the only place where high risk interference has been observed.

Pacemaker therapy in low-birth-weight infants.

PubMed

Fuchigami, Tai; Nishioka, Masahiko; Akashige, Toru; Shimabukuro, Atsuya; Nagata, Nobuhiro

2018-02-01

Infants born with complete atrioventricular block (CAVB) and fetal bradycardia are frequently born with low birth weight. Three low-birth-weight CAVB infants underwent temporary pacemaker implantation, followed by permanent single-chamber pacemaker implantation at median body weights of 1.7 and 3.2 kg, respectively. All infants caught up with their growth curves and had >3 years of estimated residual battery life. This two-stage strategy was successful in facilitating permanent pacemaker implantation in low-birth-weight babies. Placement of single-chamber pacemaker on the apex of the left ventricle appears to be associated with longer battery lifespan. © 2018 Wiley Periodicals, Inc.

Effect on pacemakers of airport weapons detectors

PubMed Central

Johnson, David L.

1974-01-01

An investigation was carried out using a variety of pacemakers and all the types of weapons detectors in common use in Canada, to determine whether or not such detectors present a hazard to pacemaker bearers. The results indicate that only left-side implants of unipolar sensing pacemakers are likely to be affected, that ventricular fibrillation initiated by interference-induced competitive pacing is the only conceivable hazard, but that the probability of 10−9 for the occurrence of this event is so low that it may be completely disregarded. Physicians may therefore reassure pacemaker bearers of their safety in and around airport weapons detectors. ImagesFIG. 1 PMID:4825148

Advanced Pacemaker

NASA Technical Reports Server (NTRS)

1990-01-01

Synchrony, developed by St. Jude Medical's Cardiac Rhythm Management Division (formerly known as Pacesetter Systems, Inc.) is an advanced state-of-the-art implantable pacemaker that closely matches the natural rhythm of the heart. The companion element of the Synchrony Pacemaker System is the Programmer Analyzer APS-II which allows a doctor to reprogram and fine tune the pacemaker to each user's special requirements without surgery. The two-way communications capability that allows the physician to instruct and query the pacemaker is accomplished by bidirectional telemetry. APS-II features 28 pacing functions and thousands of programming combinations to accommodate diverse lifestyles. Microprocessor unit also records and stores pertinent patient data up to a year.

Space Derived Health Aids (Cardiac Pacemaker)

NASA Technical Reports Server (NTRS)

1981-01-01

St. Jude Medical's Cardiac Rhythm Management Division's (formerly known as Pacesetter Systems, Inc.) pacer is a rechargeable cardiac pacemaker that eliminates the recurring need for surgery to implant a new battery. The Programalith is an advanced cardiac pacing system which permits a physician to reprogram a patient's implanted pacemaker without surgery. System consists of a pacemaker, together with a physician's console containing the programmer and a data printer. Signals are transmitted by wireless telemetry. Two-way communications, originating from spacecraft electrical power systems technology, allows physician to interrogate the pacemaker as to the status of the heart, then to fine tune the device to best suit the patient's needs.

Pacemakers and Implantable Defibrillators - Multiple Languages

MedlinePlus

... Multiple Languages → All Health Topics → Pacemakers and Implantable Defibrillators URL of this page: https://medlineplus.gov/languages/ ... List of All Topics All Pacemakers and Implantable Defibrillators - Multiple Languages To use the sharing features on ...

Selective interference with pacemaker activity by electrical dental devices.

PubMed

Miller, C S; Leonelli, F M; Latham, E

1998-01-01

We sought to determine whether electromagnetic interference with cardiac pacemakers occurs during the operation of contemporary electrical dental equipment. Fourteen electrical dental devices were tested in vitro for their ability to interfere with the function of two Medtronics cardiac pacemakers (one a dual-chamber, bipolar Thera 7942 pacemaker, the other a single-chamber, unipolar Minix 8340 pacemaker). Atrial and ventricular pacemaker output and electrocardiographic activity were monitored by means of telemetry with the use of a Medtronics 9760/90 programmer. Atrial and ventricular pacing were inhibited by electromagnetic interference produced by the electrosurgical unit up to a distance of 10 cm, by the ultrasonic bath cleaner up to 30 cm, and by the magnetorestrictive ultrasonic scalers up to 37.5 cm. In contrast, operation of the amalgamator, electric pulp tester, composite curing light, dental handpieces, electric toothbrush, microwave oven, dental chair and light, ENAC ultrasonic instrument, radiography unit, and sonic scaler did not alter pacing rate or rhythm. These results suggest that certain electrosurgical and ultrasonic instruments may produce deleterious effects in medically fragile patients with cardiac pacemakers.

Prediction of significant conduction disease through noninvasive assessment of cardiac calcification.

PubMed

Mainigi, Sumeet K; Chebrolu, Lakshmi Hima Bindu; Romero-Corral, Abel; Mehta, Vinay; Machado, Rodolfo Rozindo; Konecny, Tomas; Pressman, Gregg S

2012-10-01

Cardiac calcification is associated with coronary artery disease, arrhythmias, conduction disease, and adverse cardiac events. Recently, we have described an echocardiographic-based global cardiac calcification scoring system. The objective of this study was to evaluate the severity of cardiac calcification in patients with permanent pacemakers as based on this scoring system. Patients with a pacemaker implanted within the 2-year study period with a previous echocardiogram were identified and underwent blinded global cardiac calcium scoring. These patients were compared to matched control patients without a pacemaker who also underwent calcium scoring. The study group consisted of 49 patients with pacemaker implantation who were compared to 100 matched control patients. The mean calcium score in the pacemaker group was 3.3 ± 2.9 versus 1.8 ± 2.0 (P = 0.006) in the control group. Univariate and multivariate analysis revealed glomerular filtration rate and calcium scoring to be significant predictors of the presence of a pacemaker. Echocardiographic-based calcium scoring correlates with the presence of severe conduction disease requiring a pacemaker. © 2012, Wiley Periodicals, Inc.

Stochastic resonance on a modular neuronal network of small-world subnetworks with a subthreshold pacemaker

NASA Astrophysics Data System (ADS)

Yu, Haitao; Wang, Jiang; Liu, Chen; Deng, Bin; Wei, Xile

2011-12-01

We study the phenomenon of stochastic resonance on a modular neuronal network consisting of several small-world subnetworks with a subthreshold periodic pacemaker. Numerical results show that the correlation between the pacemaker frequency and the dynamical response of the network is resonantly dependent on the intensity of additive spatiotemporal noise. This effect of pacemaker-driven stochastic resonance of the system depends extensively on the local and the global network structure, such as the intra- and inter-coupling strengths, rewiring probability of individual small-world subnetwork, the number of links between different subnetworks, and the number of subnetworks. All these parameters play a key role in determining the ability of the network to enhance the noise-induced outreach of the localized subthreshold pacemaker, and only they bounded to a rather sharp interval of values warrant the emergence of the pronounced stochastic resonance phenomenon. Considering the rather important role of pacemakers in real-life, the presented results could have important implications for many biological processes that rely on an effective pacemaker for their proper functioning.

Development of pacemaker properties and rhythmogenic mechanisms in the mouse embryonic respiratory network

PubMed Central

Chevalier, Marc; Toporikova, Natalia; Simmers, John; Thoby-Brisson, Muriel

2016-01-01

Breathing is a vital rhythmic behavior generated by hindbrain neuronal circuitry, including the preBötzinger complex network (preBötC) that controls inspiration. The emergence of preBötC network activity during prenatal development has been described, but little is known regarding inspiratory neurons expressing pacemaker properties at embryonic stages. Here, we combined calcium imaging and electrophysiological recordings in mouse embryo brainstem slices together with computational modeling to reveal the existence of heterogeneous pacemaker oscillatory properties relying on distinct combinations of burst-generating INaP and ICAN conductances. The respective proportion of the different inspiratory pacemaker subtypes changes during prenatal development. Concomitantly, network rhythmogenesis switches from a purely INaP/ICAN-dependent mechanism at E16.5 to a combined pacemaker/network-driven process at E18.5. Our results provide the first description of pacemaker bursting properties in embryonic preBötC neurons and indicate that network rhythmogenesis undergoes important changes during prenatal development through alterations in both circuit properties and the biophysical characteristics of pacemaker neurons. DOI: http://dx.doi.org/10.7554/eLife.16125.001 PMID:27434668

Biological pacemaker created by minimally invasive somatic reprogramming in pigs with complete heart block

PubMed Central

Hu, Yu-Feng; Dawkins, James Frederick; Cho, Hee Cheol; Marbán, Eduardo; Cingolani, Eugenio

2016-01-01

Somatic reprogramming by reexpression of the embryonic transcription factor T-box 18 (TBX18) converts cardiomyocytes into pacemaker cells. We hypothesized that this could be a viable therapeutic avenue for pacemaker-dependent patients afflicted with device-related complications, and therefore tested whether adenoviral TBX18 gene transfer could create biological pacemaker activity in vivo in a large-animal model of complete heart block. Biological pacemaker activity, originating from the intramyocardial injection site, was evident in TBX18-transduced animals starting at day 2 and persisted for the duration of the study (14 days) with minimal backup electronic pacemaker use. Relative to controls transduced with a reporter gene, TBX18-transduced animals exhibited enhanced autonomic responses and physiologically superior chronotropic support of physical activity. Induced sinoatrial node cells could be identified by their distinctive morphology at the site of injection in TBX18-transduced animals, but not in controls. No local or systemic safety concerns arose. Thus, minimally invasive TBX18 gene transfer creates physiologically relevant pacemaker activity in complete heart block, providing evidence for therapeutic somatic reprogramming in a clinically relevant disease model. PMID:25031269

Involvement of mitochondrial Na+–Ca2+ exchange in intestinal pacemaking activity

PubMed Central

Kim, Byung Joo; Jun, Jae Yeoul; So, Insuk; Kim, Ki Whan

2006-01-01

AIM: Interstitial cells of Cajal (ICCs) are the pacemaker cells that generate slow waves in the gastrointestinal (GI) tract. We have aimed to investigate the involvement of mitochondrial Na+-Ca2+ exchange in intestinal pacemaking activity in cultured interstitial cells of Cajal. METHODS: Enzymatic digestions were used to dissociate ICCs from the small intestine of a mouse. The whole-cell patch-clamp configuration was used to record membrane currents (voltage clamp) and potentials (current clamp) from cultured ICCs. RESULTS: Clonazepam and CGP37157 inhibited the pacemaking activity of ICCs in a dose-dependent manner. Clonazepam from 20 to 60 µmol/L and CGP37157 from 10 to 30 µmol/L effectively inhibited Ca2+ efflux from mitochondria in pacemaking activity of ICCs. The IC50s of clonazepam and CGP37157 were 37.1 and 18.2 µmol/L, respectively. The addition of 20 µmol/L NiCl2 to the internal solution caused a “wax and wane” phenomenon of pacemaking activity of ICCs. CONCLUSION: These results suggest that mitochondrial Na+-Ca2+ exchange has an important role in intestinal pacemaking activity. PMID:16521198

Effect of renal sympathetic denervation on atrial substrate remodeling in ambulatory canines with prolonged atrial pacing.

PubMed

Wang, Xule; Zhao, Qingyan; Huang, He; Tang, Yanhong; Xiao, Jinping; Dai, Zixuan; Yu, Shengbo; Huang, Congxin

2013-01-01

We have previously demonstrated that catheter-based renal sympathetic denervation (RSD) could suppress atrial fibrillation (AF) in canines with short-time rapid right atrial pacing (RAP). However, the role of renal denervation on atrial remodeling is unclear. The aim of the present study was to explore the long-term effect of RSD on the atrial remodeling during prolonged RAP. Twenty mongrel dogs were implanted with a high-frequency cardiac pacemaker with a transvenous lead inserted into the right atrial appendage. The dogs were divided into three groups: a sham-operated group (n = 6), the chronic RAP (CRAP) group (n = 7), and the CRAP+RSD group (n = 7). In the CRAP+RSD group, a pacemaker was implanted 6 weeks after RSD was performed bilaterally for recovery. RAP was maintained for 5 weeks in CRAP group and CRAP+RSD group. The plasma levels of Angiotensin II and aldosterone were significantly increased in CRAP group compared with sham-operated group, but the increasing trend was inhibited in CRAP+RSD group compared with CRAP group (P<0.05). Similarly, RSD suppressed the increasing trend that prolonged RAP produced in the left atrial levels of ANP, TNF-α and IL-6. Compared with the sham-operated group, the CRAP group had significantly increased levels of caspase-3, bax and Cx40 whereas the level of Bcl-2 decreased (P<0.05). RSD markedly reduced the upregulation of caspase-3, bax and Cx40 and the downregulation of Bcl-2 expression compared with the CRAP group (P<0.05). Picric acid-sirius red staining study suggested that RSD could markedly alleviate the lesion degree of cardic fibrosis induced by CRAP (P<0.05). Immunohistochemistry results showed that the densities of TH- and GAP43- positive nerves were significantly elevated in the CRAP group compared with the sham-operated group, while RSD operation signicantly inhibited the these changes produced by CRAP. These findings suggest that renal denervation could suppress the atrial remodeling after prolonged RAP in ambulatory canines.

Effect of Renal Sympathetic Denervation on Atrial Substrate Remodeling in Ambulatory Canines with Prolonged Atrial Pacing

PubMed Central

Wang, Xule; Zhao, Qingyan; Huang, He; Tang, Yanhong; Xiao, Jinping; Dai, Zixuan; Yu, Shengbo; Huang, Congxin

2013-01-01

We have previously demonstrated that catheter-based renal sympathetic denervation (RSD) could suppress atrial fibrillation (AF) in canines with short-time rapid right atrial pacing (RAP). However, the role of renal denervation on atrial remodeling is unclear. The aim of the present study was to explore the long-term effect of RSD on the atrial remodeling during prolonged RAP. Twenty mongrel dogs were implanted with a high-frequency cardiac pacemaker with a transvenous lead inserted into the right atrial appendage. The dogs were divided into three groups: a sham-operated group (n = 6), the chronic RAP (CRAP) group (n = 7), and the CRAP+RSD group (n = 7). In the CRAP+RSD group, a pacemaker was implanted 6 weeks after RSD was performed bilaterally for recovery. RAP was maintained for 5 weeks in CRAP group and CRAP+RSD group. The plasma levels of Angiotensin II and aldosterone were significantly increased in CRAP group compared with sham-operated group, but the increasing trend was inhibited in CRAP+RSD group compared with CRAP group (P<0.05). Similarly, RSD suppressed the increasing trend that prolonged RAP produced in the left atrial levels of ANP, TNF-α and IL-6. Compared with the sham-operated group, the CRAP group had significantly increased levels of caspase-3, bax and Cx40 whereas the level of Bcl-2 decreased (P<0.05). RSD markedly reduced the upregulation of caspase-3, bax and Cx40 and the downregulation of Bcl-2 expression compared with the CRAP group (P<0.05). Picric acid–sirius red staining study suggested that RSD could markedly alleviate the lesion degree of cardic fibrosis induced by CRAP (P<0.05). Immunohistochemistry results showed that the densities of TH- and GAP43- positive nerves were significantly elevated in the CRAP group compared with the sham-operated group, while RSD operation signicantly inhibited the these changes produced by CRAP. These findings suggest that renal denervation could suppress the atrial remodeling after prolonged RAP in ambulatory canines. PMID:23724069

1978 Pacemaker Newspaper Awards: What Makes a Pacemaker?

ERIC Educational Resources Information Center

Brasler, Wayne

1979-01-01

Lists the nine high school and college newspapers, and the one newsmagazine, that won Pacemaker Awards in 1978; discusses characteristics that make each of them outstanding, and provides reproductions of a front page from each publication. (GT)

Stem cells as biological heart pacemakers.

PubMed

Gepstein, Lior

2005-12-01

Abnormalities in the pacemaker function of the heart or in cardiac impulse conduction may result in the appearance of a slow heart rate, traditionally requiring the implantation of a permanent electronic pacemaker. In recent years, a number of experimental approaches have been developed in an attempt to generate biological alternatives to implantable electronic devices. These strategies include, initially, a number of gene therapy approaches (aiming to manipulate the expression of ionic currents or their modulators and thereby convert quiescent cardiomyocytes into pacemaking cells) and, more recently, the use of cell therapy and tissue engineering. The latter approach explored the possibility of grafting pacemaking cells, either derived directly during the differentiation of human embryonic stem cells or engineered from mesenchymal stem cells, into the myocardium. This review will describe each of these approaches, focusing mainly on the stem cell strategies, their possible advantages and shortcomings, as well as the avenues required to make biological pacemaking a clinical reality.

Biofilm on artificial pacemaker: fiction or reality?

PubMed

Santos, Ana Paula Azevedo; Watanabe, Evandro; Andrade, Denise de

2011-11-01

Cardiac pacing through cardiac pacemaker is one of the most promising alternatives in the treatment of arrhythmias, but it can cause reactions natural or complex reactions, either early or late. This study aimed to describe the scientific evidence on the risk of infection and biofilm formation associated with cardiac pacemaker. This is a study of integrative literature review. It included 14 publications classified into three thematic categories: diagnosis (microbiological and/or clinical), complications and therapy of infections. Staphylococcus epidermidis and Staphylococcus aureus were the microorganisms most frequently isolated. It was not possible to determine the incidence of infection associated with pacemakers, since the studies were generally of prevalence. In terms of therapy, the complete removal of pacemakers stood out, especially in cases of suspected biofilm. Still controversial is the use of systemic antibiotic prophylaxis in reducing the incidence of infection associated with implantation of a pacemaker.

Effects of high-intensity power-frequency electric fields on implanted modern multiprogrammable cardiac pacemakers.

PubMed

Butrous, G S; Meldrum, S J; Barton, D G; Male, J C; Bonnell, J A; Camm, A J

1982-05-01

The effect on an implanted, multiprogrammable pacemaker of power-frequency (50 Hz) electric fields up to an intensity (unperturbed value measured at 1.7 m) of 20 kV/m were assessed in ten paced patients. Radiotelemetric monitoring of the electrocardiogram allowed supervision of the electrocardiogram throughout exposure to the alternating electric field. Displacement body currents of up to 300μA were achieved depending on the position and height of the patient. None of the pacemakers was inhibited, triggered or reverted to fixed rate operation during the exposure. The programmable functions, programmability or output characteristics were not affected. Small changes in cardiac rate and rhythm elicited the correct pacemaker responses. Unlike earlier models of pacemaker, this modern implanted pacemaker, which represents `the state of the art', is not affected by 50 Hz electric fields likely to be encountered when standing underneath power lines.

A fully implantable pacemaker for the mouse: from battery to wireless power.

PubMed

Laughner, Jacob I; Marrus, Scott B; Zellmer, Erik R; Weinheimer, Carla J; MacEwan, Matthew R; Cui, Sophia X; Nerbonne, Jeanne M; Efimov, Igor R

2013-01-01

Animal models have become a popular platform for the investigation of the molecular and systemic mechanisms of pathological cardiovascular physiology. Chronic pacing studies with implantable pacemakers in large animals have led to useful models of heart failure and atrial fibrillation. Unfortunately, molecular and genetic studies in these large animal models are often prohibitively expensive or not available. Conversely, the mouse is an excellent species for studying molecular mechanisms of cardiovascular disease through genetic engineering. However, the large size of available pacemakers does not lend itself to chronic pacing in mice. Here, we present the design for a novel, fully implantable wireless-powered pacemaker for mice capable of long-term (>30 days) pacing. This design is compared to a traditional battery-powered pacemaker to demonstrate critical advantages achieved through wireless inductive power transfer and control. Battery-powered and wireless-powered pacemakers were fabricated from standard electronic components in our laboratory. Mice (n = 24) were implanted with endocardial, battery-powered devices (n = 14) and epicardial, wireless-powered devices (n = 10). Wireless-powered devices were associated with reduced implant mortality and more reliable device function compared to battery-powered devices. Eight of 14 (57.1%) mice implanted with battery-powered pacemakers died following device implantation compared to 1 of 10 (10%) mice implanted with wireless-powered pacemakers. Moreover, device function was achieved for 30 days with the wireless-powered device compared to 6 days with the battery-powered device. The wireless-powered pacemaker system presented herein will allow electrophysiology studies in numerous genetically engineered mouse models as well as rapid pacing-induced heart failure and atrial arrhythmia in mice.

A Single Center Study of 1,179 Heart Transplant Patients-Factors Affecting Pacemaker Implantation.

PubMed

Wellmann, Petra; Herrmann, Florian Ernst Martin; Hagl, Christian; Juchem, Gerd

2017-03-01

After around 10% of heart transplant patients require pacemaker implantation. The bradyarrhythmias causing pacemaker requirement include sinus node dysfunction (SND) and atrioventricular block (AVB). This study sought to define clinical predictors for pacemaker requirement as well as identify differences in the patient groups developing SND and AVB. Our operative database was used to collect retrospective recipient, donor, and operative data of all patients receiving orthotopic heart transplants between 1981 and 2016. In the 35-year period 1,179 transplants were performed (mean recipient age 45.5 ± 0.5 years, 20.4% female, 90.6% biatrial technique) with bradyarrhythmias requiring pacemaker implantation developing in 135 patients (11.5%). Independent risk factors were prolonged operative time 340 minutes versus 313 minutes (P = 0.027) and a biatrial anastomosis (P = 0.036). Ischemia time, cardiopulmonary bypass time, aortic cross clamp time, and reperfusion time all had no significant effect on pacemaker implantation rates. Similarly, whether the transplant was a reoperation, a retransplant, or performed after primary assist implantation had no effects on pacemaker implantation rates. There was no survival difference between the paced and nonpaced groups. The donor age was higher in the patients who developed AVB as the indication for pacemaker implantation (43 vs 34 years, P = 0.031). Patients with AVB had longer aortic cross clamp times and developed the arrhythmia later than those who developed SND. Use of the bicaval instead of the biatrial technique and shortened operative times should reduce pacemaker requirement after heart transplantation. Survival is not affected by this complication. © 2017 Wiley Periodicals, Inc.

Frequency of pacemaker malfunction associated with monopolar electrosurgery during pulse generator replacement or upgrade surgery.

PubMed

Lin, Yun; Melby, Daniel P; Krishnan, Balaji; Adabag, Selcuk; Tholakanahalli, Venkatakrishna; Li, Jian-Ming

2017-08-01

The aim of this study is to investigate the frequency of electrosurgery-related pacemaker malfunction. A retrospective study was conducted to investigate electrosurgery-related pacemaker malfunction in consecutive patients undergoing pulse generator (PG) replacement or upgrade from two large hospitals in Minneapolis, MN between January 2011 and January 2014. The occurrence of this pacemaker malfunction was then studied by using MAUDE database for all four major device vendors. A total of 1398 consecutive patients from 2 large tertiary referral centers in Minneapolis, MN undergoing PG replacement or upgrade surgery were retrospectively studied. Four patients (0.3% of all patients), all with pacemakers from St Jude Medical (2.8%, 4 of 142) had output failure or inappropriately low pacing rate below 30 bpm during electrosurgery, despite being programmed in an asynchronous mode. During the same period, 1174 cases of pacemaker malfunctions were reported on the same models in MAUDE database, 37 of which (3.2%) were electrosurgery-related. Twenty-four cases (65%) had output failure or inappropriate low pacing rate. The distribution of adverse events was loss of pacing (59.5%), reversion to backup pacing (32.4%), inappropriate low pacing rate (5.4%), and ventricular fibrillation (2.7%). The majority of these (78.5%) occurred during PG replacement at ERI or upgrade surgery. No electrosurgery-related malfunction was found in MAUDE database on 862 pacemaker malfunction cases during the same period from other vendors. Electrosurgery during PG replacement or upgrade surgery can trigger output failure or inappropriate low pacing rate in certain models of modern pacemakers. Cautions should be taken for pacemaker-dependent patients.

Is pacemaker therapy the right key to patients with vasovagal syncope?

PubMed

Radovanović, Nikola N; Kirćanski, Bratislav; Raspopović, Srdjan; Pavlović, Siniša U; Jovanović, Velibor; Milašinović, Goran

2016-01-01

Vasovagal syncope is the most common type of reflex syncope. Efficacy of cardiac pacing in this indication has not been the subject of many studies and pacemaker therapy in patients with vasovagal syncope is still controversial. This study aimed to assess the efficacy and safety of pacing therapy in treatment of patients with vasovagal syncope, to determine contribution of new therapeutic models in increasing its success, and to identify risk factors associated with a higher rate of symptoms after pacemaker implantation. A retrospective study included 30 patients with pacemaker implanted due to vasovagal syncope in the Pacemaker Center, Clinical Center of Serbia, between November 2003 and June 2014. Head-up tilt test was performed to diagnose vasovagal syncope. Patients with cardioinhibitory and mixed type of disease were enrolled in the study. Mean age was 48.1 ± 11.1 years and 18 (60%) patients were men. Mean follow-up period was 5.9 ± 3.0 years. Primarily, implantable loop recorder was implanted in 10 (33.3%) patients. Twenty (66.7%) patients presented cardioinhibitory and 10 (33.3%) mixed type of vasovagal syncope. After pacemaker implantation, 11 (36.7%) patients had syncope. In multiple logistic regression analysis we showed that syncope is statistically more likely to occur after pacemaker implantation in patients with mixed type of vasovagal syncope (p = 0.018). There were two (6.7%) perioperative surgical complications. Pacemaker therapy is a safe treatment for patients with vasovagal syncope, whose efficacy can be improved by strict selection of patients. We showed that symptoms occur statistically more often in patients with mixed type of disease after pacemaker implantation.

Low pacemaker incidence with continuous-sutured valves: a retrospective analysis.

PubMed

Niclauss, Lars; Delay, Dominique; Pfister, Raymond; Colombier, Sebastien; Kirsch, Matthias; Prêtre, René

2017-06-01

Background Permanent pacemaker implantation after surgical aortic valve replacement depends on patient selection and risk factors for conduction disorders. We aimed to identify risk criteria and obtain a selected group comparable to patients assigned to transcatheter aortic valve implantation. Methods Isolated sutured aortic valve replacements in 994 patients treated from 2007 to 2015 were reviewed. Demographics, hospital stay, preexisting conduction disorders, surgical technique, and etiology in patients with and without permanent pacemaker implantation were compared. Reported outcomes after transcatheter aortic valve implantation were compared with those of a subgroup including only degenerative valve disease and first redo. Results The incidence of permanent pacemaker implantation was 2.9%. Longer hospital stay ( p = 0.01), preexisting rhythm disorders ( p < 0.001), complex prosthetic endocarditis ( p = 0.01), and complex redo ( p < 0.001) were associated with permanent pacemaker implantation. Although prostheses were sutured with continuous monofilament in the majority of cases (86%), interrupted pledgetted sutures were used more often in the pacemaker group ( p = 0.002). In the subgroup analysis, the incidence of permanent pacemaker implantation was 2%; preexisting rhythm disorders and the suture technique were still major risk factors. Conclusion Permanent pacemaker implantation depends on etiology, preexisting rhythm disorders, and suture technique, and the 2% incidence compares favorably with the reported 5- to 10-fold higher incidence after transcatheter aortic valve implantation. Cost analysis should take this into account. Often dismissed as minor complication, permanent pacemaker implantation increases the risks of endocarditis, impaired myocardial recovery, and higher mortality if associated with prosthesis regurgitation.

Adjustment of the evoked response sensitivity after hospital discharge in pacemaker patients with automatic ventricular threshold tracking activated.

PubMed

Schuchert, A; Ventura, R; Meinertz, T

2001-02-01

Automatic threshold tracking in cardiac pacemakers allows ventricular capture verification and self-adaptive pacing output regulation. The Autocapture algorithm detects the evoked response (ER) signal immediately after the pacing pulse to verify the efficacy of ventricular pacing. Before hospital delivery, the ER sensitivity must be programmed individually so that the pacemaker detects the ER signal adequately without sensing lead polarization. The aims of the study were to assess the frequency of patients in whom Autocapture could be activated and whether the ER sensitivity had to be adjusted after hospital discharge. The study included 44 patients who received the VVIR pacemaker Regency SR+ (St. Jude Medical) connected to the model 1450 T pacing lead. ER signal, lead polarization, and ER sensitivity were evaluated before hospital discharge and 1, 3, and 6 months after implantation. The system recommended activating Autocapture in 42 of 44 patients. The mean ER signal was 8.4+/-1.2 mV at discharge, 9.0+/-3.9 mV at month 1, 8.9+/-4.9 mV at month 3, and 9.3+/-4.5 mV at month 6. Polarization was 1.0+/-0.1 mV at discharge, 1.1+/-0.5 mV at month 1, 1.1+/-0.2 mV at month 3, and 1.1+/-0.5 mV at month 6. Mean ER sensitivity was 3.7+/-1.8 mV at discharge, 4.0+/-1.8 mV after 1, 4.1+/-2.2 mV after 3, and 4.1+/-1.8 mV after 6 months. ER sensitivity could remain unadjusted in 14 patients. Programming to a less sensitive ER setting from 2.9+/-1.2 mV to 4.3+/-1.5 mV was possible in 21 patients. Programming to a more sensitive ER setting from 4.1+/-1.1 mV to 2.5+/-0.9 mV was required in nine patients because of the decrease of the ER signal. The automatic threshold tracking algorithm Autocapture could be activated in 95% of patients. Programming to more sensitive ER settings was recommended in 21% of the patients after hospital discharge. Therefore, ER signal and polarization must be checked at each follow-up, as a decrease in ER signal amplitude can make reprogramming of the ER sensitivity necessary. There is no risk for the patient if the ER is not sensed, as high voltage backup stimulation is present.

Extension of generator longevity by use of high impedance ventricular leads.

PubMed

Scherer, M; Ezziddin, K; Klesius, A; Skupin, M; Helms, S; Moritz, A; Olbrich, H G

2001-02-01

The resistance of a pacing lead negatively correlates to current consumption. A prospective, randomized trial was conducted to evaluate the effect of a high impedance ventricular lead (CapSure Z) on generator longevity compared to a conventional lead (CapSure SP) eighty-nine patients were included in the study (51 male, 37 female, age 70.0+/-10.3 years). Forty-six patients received a CapSure SP lead (5024 bipolar), and 43 patients received a CapSure Z lead (5034 bipolar) in a randomized fashion. Follow-up data collected at 5 days, 3, 6, and 12 months postimplant included: lead impedance, pacing and sensing thresholds, impulse energy, and estimated time to replacement. All parameters were collected via pacemaker telemetry; the time to replacement was calculated automatically by a programmed algorithm of the pacemaker. There was no difference in the performance of the atrial lead when a dual chamber device was indicated. The CapSure Z leads displayed statistically significant higher impedance values than the CapSure SP lead in all follow-up periods. There was no significant difference in lead related complications. No significant differences were observed between pacing and sensing thresholds in both groups. The CapSure Z leads provided a significant reduction in current drain, resulting in a reduction of mean energy consumption at the 12-month follow-up from 10.4+/-5.0 microJ in the CapSure SP group to 6.6+/-1.4 microJ in the CapSure Z group (median from 9.9 microJ to 6.9 microJ, respectively), providing an estimated increase in mean longevity of more than 1 year from 81.1+/-23.5 months in the CapSure SP group to 94.5+/-13.4 months in the CapSure Z group (median: 76.5 months to 95.0 months, respectively). The use of a high resistance lead for ventricular pacing appears to result in a clinically relevant extension of generator longevity.

Safety and feasibility of leadless pacemaker in patients undergoing atrioventricular node ablation for atrial fibrillation.

PubMed

Yarlagadda, Bharath; Turagam, Mohit K; Dar, Tawseef; Jangam, Pragna; Veerapaneni, Vaishnavi; Atkins, Donita; Bommana, Sudharani; Friedman, Paul; Deshmukh, Abhishek J; Doshi, Rahul; Reddy, Vivek Y; Dukkipati, Srinivas R; Natale, Andrea; Lakkireddy, Dhanunjaya

2018-03-01

Atrioventricular node (AVN) ablation and permanent pacing is an established strategy for rate control in the management of symptomatic atrial fibrillation (AF). Leadless pacemakers (LPs) can overcome some of the short-term and long-term limitations of conventional transvenous pacemakers (CTPs). The purpose of this study was to compare the feasibility and safety of LP with those of single-chamber CTP in patients with AF undergoing AVN ablation. We conducted a multicenter observational study of patients undergoing AVN ablation and pacemaker implantation (LP vs single-chamber CTP) between February 2014 and November 2016. The primary efficacy end points were acceptable sensing (R wave ≥5.0 mV) and pacing thresholds (≤2.0 V at 0.4 ms) at follow-up. Safety end points included device-related major and minor (early ≤1 month, late >1 month) adverse events. A total of 127 patients with LP (n = 60) and CTP (n = 67) were studied. The median follow-up was 12 months (interquartile range 12-18 months). Ninety-five percent of the LP group and 97% of the CTP group met the primary efficacy end point at follow-up (57 of 60 vs 65 of 67; P = .66). There was 1 major adverse event (loss of pacing and sensing) in the LP group and 2 (lead dislodgement) in the CTP group (1 of 60 vs 2 of 67; P = 1.00). There were 6 minor adverse events (5 early and 1 late) in the LP group and 3 (early) in the CTP group (6 of 60 vs 3 of 67; P = .30). Our results demonstrate the feasibility and safety of LP compared with CTP in patients undergoing AVN ablation for AF. Copyright © 2018 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Rescuing cardiac automaticity in L-type Cav1.3 channelopathies and beyond.

PubMed

Mesirca, Pietro; Bidaud, Isabelle; Mangoni, Matteo E

2016-10-15

Pacemaker activity of the sino-atrial node generates the heart rate. Disease of the sinus node and impairment of atrioventricular conduction induce an excessively low ventricular rate (bradycardia), which cannot meet the needs of the organism. Bradycardia accounts for about half of the total workload of clinical cardiologists. The 'sick sinus' syndrome (SSS) is characterized by sinus bradycardia and periods of intermittent atrial fibrillation. Several genetic or acquired risk factors or pathologies can lead to SSS. Implantation of an electronic pacemaker constitutes the only available therapy for SSS. The incidence of SSS is forecast to double over the next 50 years, with ageing of the general population thus urging the development of complementary or alternative therapeutic strategies. In recent years an increasing number of mutations affecting ion channels involved in sino-atrial automaticity have been reported to underlie inheritable SSS. L-type Ca v 1.3 channels play a major role in the generation and regulation of sino-atrial pacemaker activity and atrioventricular conduction. Mutation in the CACNA1D gene encoding Ca v 1.3 channels induces loss-of-function in channel activity and underlies the sino-atrial node dysfunction and deafness syndrome (SANDD). Mice lacking Ca v 1.3 channels (Ca v 1.3 -/- ) fairly recapitulate SSS and constitute a precious model to test new therapeutic approaches to handle this disease. Work in our laboratory shows that targeting G protein-gated K + (I KACh ) channels effectively rescues SSS of Ca v 1.3 -/- mice. This new concept of 'compensatory' ion channel targeting shines new light on the principles underlying the pacemaker mechanism and may open the way to new therapies for SSS. © 2016 The Authors. The Journal of Physiology © 2016 The Physiological Society.

Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study.

PubMed

Ritter, Philippe; Duray, Gabor Z; Steinwender, Clemens; Soejima, Kyoko; Omar, Razali; Mont, Lluís; Boersma, Lucas V A; Knops, Reinoud E; Chinitz, Larry; Zhang, Shu; Narasimhan, Calambur; Hummel, John; Lloyd, Michael; Simmers, Timothy Alexander; Voigt, Andrew; Laager, Verla; Stromberg, Kurt; Bonner, Matthew D; Sheldon, Todd J; Reynolds, Dwight

2015-10-01

Permanent cardiac pacing is the only effective treatment for symptomatic bradycardia, but complications associated with conventional transvenous pacing systems are commonly related to the pacing lead and pocket. We describe the early performance of a novel self-contained miniaturized pacemaker. Patients having Class I or II indication for VVI pacing underwent implantation of a Micra transcatheter pacing system, from the femoral vein and fixated in the right ventricle using four protractible nitinol tines. Prespecified objectives were >85% freedom from unanticipated serious adverse device events (safety) and <2 V 3-month mean pacing capture threshold at 0.24 ms pulse width (efficacy). Patients were implanted (n = 140) from 23 centres in 11 countries (61% male, age 77.0 ± 10.2 years) for atrioventricular block (66%) or sinus node dysfunction (29%) indications. During mean follow-up of 1.9 ± 1.8 months, the safety endpoint was met with no unanticipated serious adverse device events. Thirty adverse events related to the system or procedure occurred, mostly due to transient dysrhythmias or femoral access complications. One pericardial effusion without tamponade occurred after 18 device deployments. In 60 patients followed to 3 months, mean pacing threshold was 0.51 ± 0.22 V, and no threshold was ≥2 V, meeting the efficacy endpoint (P < 0.001). Average R-wave was 16.1 ± 5.2 mV and impedance was 650.7 ± 130 ohms. Early assessment shows the transcatheter pacemaker can safely and effectively be applied. Long-term safety and benefit of the pacemaker will further be evaluated in the trial. ClinicalTrials.gov ID NCT02004873. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

Influence of internal current and pacing current on pacemaker longevity.

PubMed

Schuchert, A; Kuck, K H

1994-01-01

The effects of lower pulse amplitude on battery current and pacemaker longevity were studied comparing the new, small-sized VVI pacemaker, Minix 8341, with the former model, Pasys 8329. Battery current was telemetrically measured at 0.8, 1.6, 2.5, and 5.0 V pulse amplitude and 0.05, 0.25, 0.5, and 1.0 msec pulse duration. Internal current was assumed to be equal to the battery current at 0.8 V and 0.05 msec. Pacing current was calculated subtracting internal current from battery current. The Minix pacemaker had a significantly lower battery current because of a lower internal current (Minix: 4.1 +/- 0.1 microA; Pasys: 16.1 +/- 0.1 microA); pacing current of both units was similar. At 0.5 msec pulse duration, the programming from 5.0-2.5 V pulse amplitude resulted in a greater relative reduction of battery current in the newer pacemaker (51% vs 25%). Projected longevity of each pacemaker was 7.9 years at 5.0 V and 0.5 msec. The programming from 5.0-2.5 V extended the projected longevity by 2.3 years (Pasys) and by 7.1 years (Minix). The longevity was negligibly longer after programming to 1.6 V. extension of pacemaker longevity can be achieved with the programming to 2.5 V or less if the connected pacemakers need a low internal current for their circuitry.

Transvenous permanent pacemaker implantation in dextrocardia: technique, challenges, outcome, and a brief review of literature.

PubMed

Shenthar, Jayaprakash; Rai, Maneesh K; Walia, Rohit; Ghanta, Somasekhar; Sreekumar, Praveen; Reddy, Satish S

2014-09-01

Dextrocardia is a rare congenital anomaly. Pacemaker implantation in dextrocardia can be challenging because of the distorted anatomy and associated anomalies. The literature regarding implantation of pacemaker in dextrocardia is scarce. The study involved retrospective analysis of records of patients with dextrocardia who had undergone pacemaker implantation between January 2006 and July 2013 from a single centre. Six patients with dextrocardia (five males and one female) underwent permanent pacemaker implantation (PPI) between January 2006 and July 2013. Of them, three had situs solitus dextrocardia and three situs inversus dextrocardia. All three patients with situs solitus dextrocardia had associated corrected transposition of great arteries. The indication for pacemaker implantation was symptomatic complete atrioventricular (AV) block in four, high-grade AV block in one, and sinus node dysfunction in one patient. A favourable outcome was noted during a mean follow-up of 3.9 years (4 months to 7 years) with one patient needing a pulse generator replacement. Permanent pacemaker implantation in dextrocardia can be challenging because of the distorted anatomy. Use of a technique employing angiography to delineate chamber anatomy and relationship can assist the operator during such difficult PPIs. The medium- and long-term survival after a successful pacemaker implantation in dextrocardia is favourable. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

[Analysis of pacemaker ECGs].

PubMed

Israel, Carsten W; Ekosso-Ejangue, Lucy; Sheta, Mohamed-Karim

2015-09-01

The key to a successful analysis of a pacemaker electrocardiogram (ECG) is the application of the systematic approach used for any other ECG without a pacemaker: analysis of (1) basic rhythm and rate, (2) QRS axis, (3) PQ, QRS and QT intervals, (4) morphology of P waves, QRS, ST segments and T(U) waves and (5) the presence of arrhythmias. If only the most obvious abnormality of a pacemaker ECG is considered, wrong conclusions can easily be drawn. If a systematic approach is skipped it may be overlooked that e.g. atrial pacing is ineffective, the left ventricle is paced instead of the right ventricle, pacing competes with intrinsic conduction or that the atrioventricular (AV) conduction time is programmed too long. Apart from this analysis, a pacemaker ECG which is not clear should be checked for the presence of arrhythmias (e.g. atrial fibrillation, atrial flutter, junctional escape rhythm and endless loop tachycardia), pacemaker malfunction (e.g. atrial or ventricular undersensing or oversensing, atrial or ventricular loss of capture) and activity of specific pacing algorithms, such as automatic mode switching, rate adaptation, AV delay modifying algorithms, reaction to premature ventricular contractions (PVC), safety window pacing, hysteresis and noise mode. A systematic analysis of the pacemaker ECG almost always allows a probable diagnosis of arrhythmias and malfunctions to be made, which can be confirmed by pacemaker control and can often be corrected at the touch of the right button to the patient's benefit.

Conduction disturbances after TAVR: Electrophysiological studies and pacemaker dependency.

PubMed

Makki, Nader; Dollery, Jenn; Jones, Danielle; Crestanello, Juan; Lilly, Scott

Permanent pacemaker (PPM) placement occurs in 5-20% of patients after transcatheter aortic valve replacement (TAVR). Although predictors of pacemaker implantation have been established, features that predispose patients to pacemaker utilization on follow up have not been widely reported. We performed a retrospective review of patients undergoing commercial TAVR between 2011 and 2016. We collated patients that underwent in-hospital PPM implantation and had a follow up of at least 3months. Data abstraction was performed for electrophysiological studies (EPS), pacemaker indication, timing, and device interrogation for pacemaker dependency on follow up. A total of 24 patients received in-hospital PPM post-TAVR (14% of total cohort), and mean follow up was 22months. Indications for PPM included resting complete heart block (CHB; 15/24, 63%), left bundle branch block and abnormal electrophysiological study (EPS; 7/24, 29%), alternating bundle branch block (1/24, 4%) and tachy-brady syndrome (1/24, 4%). Pacemaker dependency (underlying ventricular asystole, complete heart block, or >50% pacing) occurred in 8/24 patients (33%) during follow-up, 7 of whom had resting CHB, and one with CHB invoked during EPS. Pacemaker dependency after TAVR is common among those that exhibited CHB, but not among those with a prolonged HV delay during EPS. Although preliminary, these observations are relevant to management of rhythm disturbances after TAVR, and may inform the practice of EPS-based PPM implantation. Copyright © 2017 Elsevier Inc. All rights reserved.

Survival time with pacemaker implantation for dogs diagnosed with persistent atrial standstill.

PubMed

Cervenec, R M; Stauthammer, C D; Fine, D M; Kellihan, H B; Scansen, B A

2017-06-01

To evaluate survival time in dogs with persistent atrial standstill after pacemaker implantation and to compare the survival times for cardiac-related vs. non-cardiac deaths. Secondary objectives were to evaluate the effects of breed and the presence of congestive heart failure (CHF) at the time of diagnosis on survival time. Twenty dogs with persistent atrial standstill and pacemaker implantation. Medical records were searched to identify dogs diagnosed with persistent atrial standstill based on electrocardiogram that underwent pacemaker implantation. Survival after pacemaker implantation was analyzed using the Kaplan-Meier method. The median survival time after pacemaker implantation for all-cause mortality was 866 days. There was no significant difference (p=0.573) in median survival time for cardiac (506 days) vs. non-cardiac deaths (400 days). The presence of CHF at the time of diagnosis did not affect the survival time (P=0.854). No difference in median survival time was noted between breeds (P=0.126). Dogs with persistent atrial standstill have a median survival time of 866 days with pacemaker implantation, though a wide range of survival times was observed. There was no difference in the median survival time for dogs with cardiac-related deaths and those without. Patient breed and the presence of CHF before pacemaker implantation did not affect median survival time. Copyright © 2017 Elsevier B.V. All rights reserved.

Carbachol regulates pacemaker activities in cultured interstitial cells of Cajal from the mouse small intestine.

PubMed

So, Keum Young; Kim, Sang Hun; Sohn, Hong Moon; Choi, Soo Jin; Parajuli, Shankar Prasad; Choi, Seok; Yeum, Cheol Ho; Yoon, Pyung Jin; Jun, Jae Yeoul

2009-05-31

We studied the effect of carbachol on pacemaker currents in cultured interstitial cells of Cajal (ICC) from the mouse small intestine by muscarinic stimulation using a whole cell patch clamp technique and Ca2+-imaging. ICC generated periodic pacemaker potentials in the current-clamp mode and generated spontaneous inward pacemaker currents at a holding potential of-70 mV. Exposure to carbachol depolarized the membrane and produced tonic inward pacemaker currents with a decrease in the frequency and amplitude of the pacemaker currents. The effects of carbachol were blocked by 1-dimethyl-4-diphenylacetoxypiperidinium, a muscarinic M(3) receptor antagonist, but not by methotramine, a muscarinic M(2) receptor antagonist. Intracellular GDP-beta-S suppressed the carbachol-induced effects. Carbachol-induced effects were blocked by external Na+-free solution and by flufenamic acid, a non-selective cation channel blocker, and in the presence of thapsigargin, a Ca2+-ATPase inhibitor in the endoplasmic reticulum. However, carbachol still produced tonic inward pacemaker currents with the removal of external Ca2+. In recording of intracellular Ca2+ concentrations using fluo 3-AM dye, carbachol increased intracellular Ca2+ concentrations with increasing of Ca2+ oscillations. These results suggest that carbachol modulates the pacemaker activity of ICC through the activation of non-selective cation channels via muscarinic M(3) receptors by a G-protein dependent intracellular Ca2+ release mechanism.

Performance of re-used pacemakers and implantable cardioverter defibrillators compared with new devices at Groote Schuur Hospital in Cape Town, South Africa

PubMed Central

Jama, Zimasa V; Chin, Ashley; Mayosi, Bongani M; Badri, Motasim

2015-01-01

Objectives Little is known about the performance of re-used pacemakers and implantable cardioverter defibrillators (ICDs) in Africa. We sought to compare the risk of infection and the rate of malfunction of re-used pacemakers and ICDs with new devices implanted at Groote Schuur Hospital in Cape Town, South Africa. Methods This was a retrospective case comparison study of the performance of re-used pacemakers and ICDs in comparison with new devices implanted at Groote Schuur Hospital over a 10-year period. The outcomes were incidence of device infection, device malfunction, early battery depletion, and device removal due to infection, malfunction, or early battery depletion. Results Data for 126 devices implanted in 126 patients between 2003 and 2013 were analysed, of which 102 (81%) were pacemakers (51 re-used and 51 new) and 24 (19%) were ICDs (12 re-used and 12 new). There was no device infection, malfunction, early battery depletion or device removal in either the re-used or new pacemaker groups over the median follow up of 15.1 months [interquartile range (IQR), 1.3–36.24 months] for the re-used pacemakers, and 55.8 months (IQR, 20.3–77.8 months) for the new pacemakers. In the ICD group, no device infection occurred over a median follow up of 35.9 months (IQR, 17.0–70.9 months) for the re-used ICDs and 45.7 months (IQR, 37.6–53.7 months) for the new ICDs. One device delivered inappropriate shocks, which resolved without intervention and with no harm to the patient. This re-used ICD subsequently needed generator replacement 14 months later. In both the pacemaker and ICD groups, there were no procedure-non-related infections documented for the respective follow-up periods. Conclusion No significant differences were found in performance between re-used and new pacemakers and ICDs with regard to infection rates, device malfunction, battery life and device removal for complications. Pacemaker and ICD re-use is feasible and safe and is a viable option for patients with bradyarrhythmias and tachyarrthythmias. PMID:26407220

What Is a Pacemaker?

MedlinePlus

... your pacemaker. • If you work around industrial microwaves, electricity, cars or other large motors, ask your doctor about possible effects. Can I use a cell phone or microwave oven if I have a pacemaker? Microwave ovens, electric blankets, remote controls for TV and other common ...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker programmers. 870.3700 Section 870.3700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers...

Haemophilus parainfluenzae bacteremia associated with a pacemaker wire localized by gallium scan

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rosenbaum, G.S.; Calubiran, O.; Cunha, B.A.

1990-05-01

A young woman with a history of sick sinus syndrome and placement of a permanent pacemaker 6 months before admission had fever and Haemophilus parainfluenzae bacteremia. A gallium scan localized the infection to the site of the pacemaker wire. Echocardiograms were negative for any vegetations. The patient responded to cefotaxime and trimethoprim-sulfamethoxazole therapy. We believe that this is the first case of H. parainfluenzae bacteremia associated with a pacemaker wire and localized by gallium scan.

Of pacemakers and statistics: the actuarial method extended.

PubMed

Dussel, J; Wolbarst, A B; Scott-Millar, R N; Obel, I W

1980-01-01

Pacemakers cease functioning because of either natural battery exhaustion (nbe) or component failure (cf). A study of four series of pacemakers shows that a simple extension of the actuarial method, so as to incorporate Normal statistics, makes possible a quantitative differentiation between the two modes of failure. This involves the separation of the overall failure probability density function PDF(t) into constituent parts pdfnbe(t) and pdfcf(t). The approach should allow a meaningful comparison of the characteristics of different pacemaker types.

Self-Diagnostics Digitally Controlled Pacemaker/Defibrillators: A Design Plan for Incorporating Diagnostics and Digital Control in the schema of a Pacemaker/Defibrillator Design

DTIC Science & Technology

2005-09-01

of a system to store and retrieve digital/ wireless communication information from a pacemaker/ defibrillator, or other device , and to alert medical... wireless communication information from a pacemaker/defibrillator, or other device , and to alert medical personnel when a person is experiencing...with heart, pacing, program, test, sensor , circuit) where the individual needs immediate attention an audible alert will go off at the nurse’s

A Leadless Intracardiac Transcatheter Pacing System.

PubMed

Reynolds, Dwight; Duray, Gabor Z; Omar, Razali; Soejima, Kyoko; Neuzil, Petr; Zhang, Shu; Narasimhan, Calambur; Steinwender, Clemens; Brugada, Josep; Lloyd, Michael; Roberts, Paul R; Sagi, Venkata; Hummel, John; Bongiorni, Maria Grazia; Knops, Reinoud E; Ellis, Christopher R; Gornick, Charles C; Bernabei, Matthew A; Laager, Verla; Stromberg, Kurt; Williams, Eric R; Hudnall, J Harrison; Ritter, Philippe

2016-02-11

A leadless intracardiac transcatheter pacing system has been designed to avoid the need for a pacemaker pocket and transvenous lead. In a prospective multicenter study without controls, a transcatheter pacemaker was implanted in patients who had guideline-based indications for ventricular pacing. The analysis of the primary end points began when 300 patients reached 6 months of follow-up. The primary safety end point was freedom from system-related or procedure-related major complications. The primary efficacy end point was the percentage of patients with low and stable pacing capture thresholds at 6 months (≤2.0 V at a pulse width of 0.24 msec and an increase of ≤1.5 V from the time of implantation). The safety and efficacy end points were evaluated against performance goals (based on historical data) of 83% and 80%, respectively. We also performed a post hoc analysis in which the rates of major complications were compared with those in a control cohort of 2667 patients with transvenous pacemakers from six previously published studies. The device was successfully implanted in 719 of 725 patients (99.2%). The Kaplan-Meier estimate of the rate of the primary safety end point was 96.0% (95% confidence interval [CI], 93.9 to 97.3; P<0.001 for the comparison with the safety performance goal of 83%); there were 28 major complications in 25 of 725 patients, and no dislodgements. The rate of the primary efficacy end point was 98.3% (95% CI, 96.1 to 99.5; P<0.001 for the comparison with the efficacy performance goal of 80%) among 292 of 297 patients with paired 6-month data. Although there were 28 major complications in 25 patients, patients with transcatheter pacemakers had significantly fewer major complications than did the control patients (hazard ratio, 0.49; 95% CI, 0.33 to 0.75; P=0.001). In this historical comparison study, the transcatheter pacemaker met the prespecified safety and efficacy goals; it had a safety profile similar to that of a transvenous system while providing low and stable pacing thresholds. (Funded by Medtronic; Micra Transcatheter Pacing Study ClinicalTrials.gov number, NCT02004873.).

A Fully Implantable Pacemaker for the Mouse: From Battery to Wireless Power

PubMed Central

Zellmer, Erik R.; Weinheimer, Carla J.; MacEwan, Matthew R.; Cui, Sophia X.; Nerbonne, Jeanne M.; Efimov, Igor R.

2013-01-01

Animal models have become a popular platform for the investigation of the molecular and systemic mechanisms of pathological cardiovascular physiology. Chronic pacing studies with implantable pacemakers in large animals have led to useful models of heart failure and atrial fibrillation. Unfortunately, molecular and genetic studies in these large animal models are often prohibitively expensive or not available. Conversely, the mouse is an excellent species for studying molecular mechanisms of cardiovascular disease through genetic engineering. However, the large size of available pacemakers does not lend itself to chronic pacing in mice. Here, we present the design for a novel, fully implantable wireless-powered pacemaker for mice capable of long-term (>30 days) pacing. This design is compared to a traditional battery-powered pacemaker to demonstrate critical advantages achieved through wireless inductive power transfer and control. Battery-powered and wireless-powered pacemakers were fabricated from standard electronic components in our laboratory. Mice (n = 24) were implanted with endocardial, battery-powered devices (n = 14) and epicardial, wireless-powered devices (n = 10). Wireless-powered devices were associated with reduced implant mortality and more reliable device function compared to battery-powered devices. Eight of 14 (57.1%) mice implanted with battery-powered pacemakers died following device implantation compared to 1 of 10 (10%) mice implanted with wireless-powered pacemakers. Moreover, device function was achieved for 30 days with the wireless-powered device compared to 6 days with the battery-powered device. The wireless-powered pacemaker system presented herein will allow electrophysiology studies in numerous genetically engineered mouse models as well as rapid pacing-induced heart failure and atrial arrhythmia in mice. PMID:24194832

Inward-rectifying potassium (Kir) channels regulate pacemaker activity in spinal nociceptive circuits during early life

PubMed Central

Li, Jie; Blankenship, Meredith L.; Baccei, Mark L.

2013-01-01

Pacemaker neurons in neonatal spinal nociceptive circuits generate intrinsic burst-firing and are distinguished by a lower “leak” membrane conductance compared to adjacent, non-bursting neurons. However, little is known about which subtypes of leak channels regulate the level of pacemaker activity within the developing rat superficial dorsal horn (SDH). Here we demonstrate that a hallmark feature of lamina I pacemaker neurons is a reduced conductance through inward-rectifying potassium (Kir) channels at physiological membrane potentials. Differences in the strength of inward rectification between pacemakers and non-pacemakers indicate the presence of functionally distinct Kir currents in these two populations at room temperature. However, Kir currents in both groups showed high sensitivity to block by extracellular Ba2+ (IC50 ~ 10 µM), which suggests the presence of ‘classical’ Kir (Kir2.x) channels in the neonatal SDH. The reduced Kir conductance within pacemakers is unlikely to be explained by an absence of particular Kir2.x isoforms, as immunohistochemical analysis revealed the expression of Kir2.1, Kir2.2 and Kir2.3 within spontaneously bursting neurons. Importantly, Ba2+ application unmasked rhythmic burst-firing in ~42% of non-bursting lamina I neurons, suggesting that pacemaker activity is a latent property of a sizeable population of SDH cells during early life. In addition, the prevalence of spontaneous burst-firing within lamina I was enhanced in the presence of high internal concentrations of free Mg2+, consistent with its documented ability to block Kir channels from the intracellular side. Collectively, the results indicate that Kir channels are key modulators of pacemaker activity in newborn central pain networks. PMID:23426663

Current facts on pacemaker electromagnetic interference and their application to clinical care

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sager, D.P.

1987-03-01

The development of the sensing demand cardiac pacemaker brought with it the problem of interference as a result of extraneous electric current and electromagnetic fields. This problem still deserves consideration, not only because harmful disruption of pacemaker function, while infrequent, can occur but also because myths and misunderstandings have flourished on the subject. Misinformation has often led to needless patient anxiety and unnecessary restrictions in activities of daily living. Similarly, when health care practitioners are misinformed about pacemaker interference, potentially hazardous situations can occur in the clinical environment. This article is a review of current information on the sources andmore » effects of electromagnetic interference (EMI) on pacemakers and includes a discussion of their application to patient care.« less

Monitoring the radiation dose to a multiprogrammable pacemaker during radical radiation therapy: A case report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Muller-Runkel, R.; Orsolini, G.; Kalokhe, U.P.

1990-11-01

Multiprogrammable pacemakers, using complimentary metaloxide semiconductor (CMOS) circuitry, may fail during radiation therapy. We report about a patient who received 6,400 cGy for unresectable carcinoma of the left lung. In supine treatment position, arms raised above the head, the pacemaker was outside the treated area by a margin of at least 1 cm, shielded by cerrobend blocking mounted on a tray. From thermoluminescent dosimeter (TLD) measurements, we estimate that the pacemaker received 620 cGy in scatter doses. Its function was monitored before, during, and after completion of radiation therapy. The pacemaker was functioning normally until the patient's death 5 monthsmore » after completion of treatment. The relevant electrocardiograms (ECGs) are presented.« less

21 CFR 870.3670 - Pacemaker charger.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker charger. 870.3670 Section 870.3670 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3670 Pacemaker charger. (a...

Could persistency of current of injury forecast successful active-fixation pacing lead implantation?

PubMed

Shali, Shalaimaiti; Su, Yangang; Qin, Shengmei; Ge, Junbo

2018-05-01

Presence of adequate current of injury (COI) was recognized as a sign of favorable pacemaker lead outcome. Little is known regarding the value of its dynamic behavior. We sought to test whether persistency of COI could predict active-fixation pacing lead performance. COI was monitored up to 10min after right ventricular (RV) pacing electrode fixation. COI persistency was defined as the percentage of COI magnitude relative to its initial measurement. An unacceptable pacing threshold (≥1.0V in acute evaluation or ≥2.0V over 2-year follow-up) with or without lead dislodgement was considered as lead failure. Lead implantation was attempted for 217 times in 174 patients (age 66.3±7.8years, 78 female). Acute lead failures occurred 43 times. Independent predictors of acute lead failure were RV enlargement (odds ratio [OR] 1.23, 95% confidential interval [CI] 1.11-2.04, P=0.033), absence of COI (OR 3.13, 95%CI 2.08-9.09, P=0.027), and COI persistency at 5min (OR 0.32, 95%CI 0.20-0.69, P=0.001) and 10min (OR 0.41, 95%CI 0.13-0.77, P=0.001). The optimal cutoffs were COI 5min persistency ≥50% (sensitivity 81.4%; specificity 81.9%) and COI 10min persistency ≥20% (sensitivity 86%; specificity 88.6%). There were 12 lead failures during 24.0±6.4months of follow-up. Patients with COI 5min persistency ≥50% had higher event-free survival compared to those with COI 5min persistency <50% (hazard ratio 3.54, 95% CI 1.04-12.06, P=0.043). COI persistency appears to be a valuable indicator for both acute and long-term outcome of active-fixation pacemaker leads. A precipitous decline in COI may require more attention to make sure of the lead performance. Copyright © 2018 Elsevier Ireland Ltd. All rights reserved.

Modulation of Pacemaker Potentials in Murine Small Intestinal Interstitial Cells of Cajal by Gamisoyo-San, a Traditional Chinese Herbal Medicine.

PubMed

Kim, Doeun; Kim, Jung Nam; Nam, Joo Hyun; Lee, Jong Rok; Kim, Sang Chan; Kim, Byung Joo

2018-04-19

The Gamisoyo-san (GSS) has been used for -improving the gastrointestinal (GI) symptoms. The purpose of this study was to investigate the effects of GSS, a traditional Chinese herbal medicine, on the pacemaker potentials of mouse small intestinal interstitial cells of Cajal (ICCs). ICCs from the small intestines were dissociated and cultured. Whole-cell patch-clamp configuration was used to record pacemaker potentials and membrane currents. GSS depolarized ICC pacemaker potentials in a dose-dependent manner. Pretreatment with 4-diphenylacetoxypiperidinium iodide completely inhibited GSS-induced pacemaker potential depolarizations. Intracellular GDP-β-S inhibited GSS-induced effects, and in the presence of U-73122, GSS-induced effects were inhibited. Also, GSS in the presence of a Ca2+-free solution or thapsigargin did not depolarize pacemaker potentials. However, in the presence of calphostin C, GSS slightly depolarized pacemaker potentials. Furthermore, GSS inhibited both transient receptor potential melastatin7 and Ca2+-activated Cl- channel (anoctamin1) currents. GSS depolarized pacemaker potentials of ICCs via G protein and muscarinic M3 receptor signaling pathways and through internal or external Ca2+-, phospholipase C-, and protein kinase C-dependent and transient receptor potential melastatin 7-, and anoctamin 1-independent pathways. The study shows that GSS may regulate GI tract motility, suggesting that GSS could be a basis for developing novel prokinetic agents for treating GI motility dysfunctions. © 2018 S. Karger AG, Basel.

Comparative Study of Electrical Stimulation of the Heart with VDD and DDD Pacemakers as to the Evolution to Atrial Fibrillation

PubMed Central

de Campos, Nelson Leonardo Kerdahi Leite; de Andrade, Rubens Ramos; Fellicio, Marcello Laneza; Martins, Antônio Sergio; Garzesi, André Monti; Garcia, Leonardo Rufino; Takeda, Tassya Bueno

2017-01-01

Introduction The pacemaker implantation VDD is considered simpler, faster, less expensive and causes fewer complications compared to DDD. However, the VDD pacemaker has not been widely used in many centers, perhaps for fear of dysfunction of the sinus node and the reduction of atrial sensitivity by the pacemaker during follow-up after implantation. Objective To compare patients with DDD and VDD pacemakers regarding the evolution of chronic atrial fibrillation (AF) and length of stay outside this postoperative arrhythmia. Methods It was included 158 patients with dual chamber pacemakers, 48 DDD and 110 VDD. Follow-up period: between January 1, 1999 and December 31, 2015. The mean follow-up of patients with DDD was 5.35 years and the VDD, 4.74 years. The percentage of each group (DDD and VDD) which evolved to AF during follow-up was assessed. Also, it was made an actuarial study with the respective curves indicating the time free from AF for each group. Patients were classified according to the diagnosis that led to pacemaker implantation and the degree of heart failure. Results The percentage of patients who developed AF was higher in DDD group (10.42%) than in VDD group (6.36%), but without statistical significance. Patients with DDD and VDD remained free of AF for similar period. Conclusion Considering the results, the VDD pacemaker continues to be a good option to the DDD for routine use in cases properly indicated. PMID:29211212

Comparative Study of Electrical Stimulation of the Heart with VDD and DDD Pacemakers as to the Evolution to Atrial Fibrillation.

PubMed

Campos, Nelson Leonardo Kerdahi Leite de; Andrade, Rubens Ramos de; Fellicio, Marcello Laneza; Martins, Antônio Sergio; Garzesi, André Monti; Garcia, Leonardo Rufino; Takeda, Tassya Bueno

2017-01-01

The pacemaker implantation VDD is considered simpler, faster, less expensive and causes fewer complications compared to DDD. However, the VDD pacemaker has not been widely used in many centers, perhaps for fear of dysfunction of the sinus node and the reduction of atrial sensitivity by the pacemaker during follow-up after implantation. To compare patients with DDD and VDD pacemakers regarding the evolution of chronic atrial fibrillation (AF) and length of stay outside this postoperative arrhythmia. It was included 158 patients with dual chamber pacemakers, 48 DDD and 110 VDD. Follow-up period: between January 1, 1999 and December 31, 2015. The mean follow-up of patients with DDD was 5.35 years and the VDD, 4.74 years. The percentage of each group (DDD and VDD) which evolved to AF during follow-up was assessed. Also, it was made an actuarial study with the respective curves indicating the time free from AF for each group. Patients were classified according to the diagnosis that led to pacemaker implantation and the degree of heart failure. The percentage of patients who developed AF was higher in DDD group (10.42%) than in VDD group (6.36%), but without statistical significance. Patients with DDD and VDD remained free of AF for similar period. Considering the results, the VDD pacemaker continues to be a good option to the DDD for routine use in cases properly indicated.

Evaluation of Death among the Patients Undergoing Permanent Pacemaker Implantation: A Competing Risks Analysis.

PubMed

Ghaem, Haleh; Ghorbani, Mohammad; Zare Dorniani, Samira

2017-06-01

Permanent artificial pacemaker is one of the important therapies for treatment of cardiac conduction system problems. The present study aimed to determine the association between some predictive variables and all-cause and cause-specific mortality in the patients who had undergone pacemaker implantation. This study was conducted on 1207 patients who had undergone permanent pacemaker implantation in the hospitals affiliated with Shiraz University of Medical Sciences, Iran, from Mar 2002 to Mar 2012. The variables that existed in the patients' medical records included sex, diabetes mellitus, obesity, cerebrovascular accident, cardiomegaly, smoking, hypertension, ischemic heart disease, congenital heart disease, sick sinus syndrome, and atrial fibrillation. Competing risks model was used to assess the association between the predictive variables and cause-specific (i.e., cardiac and vascular) mortality. The patients' mean age was 66.32±17.92 yr (70.62±14.45 yr in the patients with single-chamber pacemakers vs. 61.91±17.69 yr in those with two-chamber pacemakers) ( P <0.001). Sick sinus syndrome and age increased the risk of all-cause mortality, while two-chamber pacemaker decreased this risk. Obesity increased the risk of cardiac death, and diabetes mellitus and heart valve disease increased the risk of vascular death. The variables predicting mortality in all-cause model were completely different from those in cause-specific model. Moreover, death in such patients may occur due to reasons other than pacemaker. Therefore, future studies, particularly prospective ones, are recommended to use competing risks models.

Neuropeptide Secreted from a Pacemaker Activates Neurons to Control a Rhythmic Behavior

PubMed Central

Wang, Han; Girskis, Kelly; Janssen, Tom; Chan, Jason P.; Dasgupta, Krishnakali; Knowles, James A.; Schoofs, Liliane; Sieburth, Derek

2013-01-01

Summary Background Rhythmic behaviors are driven by endogenous biological clocks in pacemakers, which must reliably transmit timing information to target tissues that execute rhythmic outputs. During the defecation motor program in C. elegans, calcium oscillations in the pacemaker (intestine), which occur about every 50 seconds, trigger rhythmic enteric muscle contractions through downstream GABAergic neurons that innervate enteric muscles. However, the identity of the timing signal released by the pacemaker and the mechanism underlying the delivery of timing information to the GABAergic neurons are unknown. Results Here we show that a neuropeptide-like protein (NLP-40) released by the pacemaker triggers a single rapid calcium transient in the GABAergic neurons during each defecation cycle. We find that mutants lacking nlp-40 have normal pacemaker function, but lack enteric muscle contractions. NLP-40 undergoes calcium-dependent release that is mediated by the calcium sensor, SNT-2/synaptotagmin. We identify AEX-2, the G protein-coupled receptor on the GABAergic neurons, as the receptor of NLP-40. Functional calcium imaging reveals that NLP-40 and AEX-2/GPCR are both necessary for rhythmic activation of these neurons. Furthermore, acute application of synthetic NLP-40-derived peptide depolarizes the GABAergic neurons in vivo. Conclusions Our results show that NLP-40 carries the timing information from the pacemaker via calcium-dependent release and delivers it to the GABAergic neurons by instructing their activation. Thus, we propose that rhythmic release of neuropeptides can deliver temporal information from pacemakers to downstream neurons to execute rhythmic behaviors. PMID:23583549

Programming and Isolation of Highly Pure Physiologically and Pharmacologically Functional Sinus-Nodal Bodies from Pluripotent Stem Cells

PubMed Central

Jung, Julia Jeannine; Husse, Britta; Rimmbach, Christian; Krebs, Stefan; Stieber, Juliane; Steinhoff, Gustav; Dendorfer, Andreas; Franz, Wolfgang-Michael; David, Robert

2014-01-01

Summary Therapeutic approaches for “sick sinus syndrome” rely on electrical pacemakers, which lack hormone responsiveness and bear hazards such as infection and battery failure. These issues may be overcome via “biological pacemakers” derived from pluripotent stem cells (PSCs). Here, we show that forward programming of PSCs with the nodal cell inducer TBX3 plus an additional Myh6-promoter-based antibiotic selection leads to cardiomyocyte aggregates consisting of >80% physiologically and pharmacologically functional pacemaker cells. These induced sinoatrial bodies (iSABs) exhibited highly increased beating rates (300–400 bpm), coming close to those found in mouse hearts, and were able to robustly pace myocardium ex vivo. Our study introduces iSABs as highly pure, functional nodal tissue that is derived from PSCs and may be important for future cell therapies and drug testing in vitro. PMID:24936448

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870.3650 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker generator function analyzer. 870.3630 Section 870.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker...

21 CFR 870.3690 - Pacemaker test magnet.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker test magnet. 870.3690 Section 870.3690 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3690 Pacemaker test magnet...

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker electrode function tester. 870.3720... electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is... measuring the patient's pacing threshold and intracardiac R-wave potential. (b) Classification. Class II...

Intercostal muscle twitching: An unusual manifestation of extracardiac stimulation related to right ventricular outflow tract pacing

PubMed Central

Erdogan, Okan

2007-01-01

The present case report describes a patient who underwent successful dual-chamber pacemaker implantation with active ventricular lead fixation at a high septal region in the right ventricular outflow tract. Unexpectedly, stimulation at a high output in the right ventricular outflow tract caused an unusual extracardiac stimulation, specifically, intercostal muscle twitching. PMID:17703261

[Vasovagal syncope as a cause of serious body injury - two case reports].

PubMed

Gajek, Jacek; Zyśko, Dorota

2003-04-01

Vasovagal syncope is a reflex reaction, leading to marked hypotension and/or bradycardia with transient loss of consciousness and the postural muscle tone. The recovery is spontaneous and usually rapid. Serious body injuries caused by fainting are rare. We present two patients with vasovagal syncope which caused serious injury. Different therapeutic options, including pacemaker implantation, are discussed.

Recent advances in pacemaker and implantable defibrillator therapy for young patients.

PubMed

Walsh, Edward P; Cecchin, Frank

2004-03-01

This review is intended to highlight major clinical advances over the past year related to (1). biventricular pacing as a treatment for dilated myopathy, (2). growing clinical experience with implantable cardioverter defibrillators in pediatrics, (3). technical advances in standard antibradycardia pacing, and (4). an appraisal of the newly updated ACC/AHA/NASPE guidelines for device implant in children and adolescents. Complex rhythm devices are being used more frequently in children. Biventricular pacing to improve ventricular contractility is a rapidly evolving technology that has now been applied to children and young adults with intraventricular conduction delay, such as bundle branch block after cardiac surgery. Implantable defibrillators are also being used for an expanding list of conditions, although lead dysfunction is seen as a fairly common complication in active young patients. Guidelines for device implantation have been developed, but the weight of evidence remains somewhat limited by the paucity of pediatric data in this field. Thanks to refinements in lead design and generator technology, coupled with rapidly expanding clinical indications, pacemakers and implantable defibrillators have become increasingly important components of cardiac therapy for young patients. Expanded multicenter clinical studies will be needed to develop more objective guidelines for use of this advanced technology.

A two dimension model of the uterine electrical wave propagation.

PubMed

Rihana, S; Lefrançois, E; Marque, C

2007-01-01

The uterus, usually quiescent during pregnancy, exhibits forceful contractions at term leading to delivery. These contractions are caused by the synchronized propagation of electrical waves from the pacemaker cells to its neighbors inducing the whole coordinated contraction of the uterus wall leading to labor. In a previous work, we simulate the electrical activity of a single uterine cell by a set of ordinary differential equations. Then, this model has been used to simulate the electrical activity propagation. In the present work, the uterine cell tissue is assumed to have uniform and isotropic propagation, and constant electrical membrane properties. The stability of the numerical solution imposes the choice of a critical temporal step. A wave starts at a pacemaker cell; this electrical activity is initiated by the injection of an external stimulation current to the cell membrane. We observe synchronous wave propagation for axial resistance values around 0.5 GOmega or less and propoagation blocking for values greater than 0.7 GOmega. We compute the conduction velocity of the excitation, for different axial resistance values, and obtain a velocity about 10 cm/sec, approaching the one described by the literature for the rat at end of term.

Feasibility of dual-chamber (DDD) pacing via a single-pass (VDD) pacing lead employing a floating atrial ring (dipole): case series, future considerations, and refinements.

PubMed

Kassotis, John; Voigt, Louis; Mongwa, Mbu; Reddy, C V R

2005-01-01

The objective of this study was to assess the feasibility of DDD pacing from a standard single-pass VDD pacemaker system. Over the past 2 decades significant advances have been made in the development of single-pass VDD pacing systems. These have been shown in long-term prospective studies to effectively preserve atrioventricular (AV)synchrony in patients with AV block and normal sinus node function. What remains problematic is the development of a single-pass pacing system capable of DDD pacing. Such a lead configuration would be useful in those patients with peripheral venous anomalies and in younger patients with congenital anomalies, which may require lead revisions in the future. In addition, with the increased use of resynchronization (biventricular pacing) therapy, the availability of a reliable single-pass lead will minimize operative time, enhance patient safety, and minimize the amount of hardware within the heart. The feasibility of DDD pacing via a Medtronic Capsure VDD-2 (Model #5038) pacing lead was evaluated. Twenty patients who presented with AV block and normal sinus node function were recruited for this study. Atrial pacing thresholds and sensitivities were assessed intraoperatively in the supine position with various respiratory maneuvers. Five patients who agreed to participate in long-term follow-up received a dual-chamber generator and were evaluated periodically over a 12-month period. Mean atrial sensitivity was 2.35 +/- 0.83 mV at the time of implantation. Effective atrial stimulation was possible in all patients at the time of implantation (mean stimulation threshold 3.08 +/- 1.04 V at 0.5 ms [bipolar], 3.34 +/- 0.95 V at 0.5 ms [unipolar]). Five of the 20 patients received a Kappa KDR701 generator, and atrial electrical properties were followed up over a 1-year period. There was no significant change in atrial pacing threshold or incidence of phrenic nerve stimulation over the 1-year follow-up. A standard single-pass VDD pacing lead system was capable of DDD pacing intraoperatively and during long-term follow-up. Despite higher than usual thresholds via the atrial dipole, pacemaker telemetry revealed < 10% use of atrial pacing dipole over a 12-month period, which would minimally deplete the pacemaker's battery. In addition, the telemetry confirmed appropriate sensing and pacing of the atrial dipole throughout the study period. At this time such systems can serve as back-up DDD pacing systems with further refinements required to optimize atrial thresholds in all patients.

76 FR 64228 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-17

...: External Pacemaker Pulse Generator; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... entitled ``Class II Special Controls Guidance Document: External Pacemaker Pulse Generator.'' This draft guidance document describes a means by which external pacemaker pulse generators may comply with the...

Two hearts synchronized each other with a DDD pacemaker.

PubMed

Brunacci, Michele; Valbusa, Alberto; Brunelli, Claudio; Bertero, Giovanni

2016-12-01

: We describe the case of a patient with dyspnea and heterotopic cardiac transplant, ventricular fibrillation from the native heart and sinus rhythm from the transplanted one. The two hearts were synchronized with a pacemaker. Electric external cardioversion and a different type of pacemaker stimulation were successfully performed, with improving symptoms.

21 CFR 870.3710 - Pacemaker repair or replacement material.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker repair or replacement material. 870.3710 Section 870.3710 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3710 Pacemaker...

Pacemaker failure associated with therapeutic radiation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brooks, C.; Mutter, M.

1988-11-01

A 48-year-old white man with a multiprogrammable Intramedics 259-01 pacemaker was treated for inoperable lung cancer with a course of cobalt-60 radiotherapy (total 3500 rad). Several weeks subsequent to his last radiation treatment, the patient presented to the emergency department with chest and abdominal pain, shortness of breath, hypotension, and tachycardia. A paced tachycardia was noted, and application of a magnet over the pacemaker completely inhibited its function, allowing a normal sinus rhythm to ensue and the patient's symptoms to be relieved. Pacemaker failure probably was a complication of radiotherapy.

Mathematical Models of Cardiac Pacemaking Function

NASA Astrophysics Data System (ADS)

Li, Pan; Lines, Glenn T.; Maleckar, Mary M.; Tveito, Aslak

2013-10-01

Over the past half century, there has been intense and fruitful interaction between experimental and computational investigations of cardiac function. This interaction has, for example, led to deep understanding of cardiac excitation-contraction coupling; how it works, as well as how it fails. However, many lines of inquiry remain unresolved, among them the initiation of each heartbeat. The sinoatrial node, a cluster of specialized pacemaking cells in the right atrium of the heart, spontaneously generates an electro-chemical wave that spreads through the atria and through the cardiac conduction system to the ventricles, initiating the contraction of cardiac muscle essential for pumping blood to the body. Despite the fundamental importance of this primary pacemaker, this process is still not fully understood, and ionic mechanisms underlying cardiac pacemaking function are currently under heated debate. Several mathematical models of sinoatrial node cell membrane electrophysiology have been constructed as based on different experimental data sets and hypotheses. As could be expected, these differing models offer diverse predictions about cardiac pacemaking activities. This paper aims to present the current state of debate over the origins of the pacemaking function of the sinoatrial node. Here, we will specifically review the state-of-the-art of cardiac pacemaker modeling, with a special emphasis on current discrepancies, limitations, and future challenges.

Dual-chamber pacemakers for treating symptomatic bradycardia due to sick sinus syndrome without atrioventricular block: a systematic review and economic evaluation.

PubMed

Edwards, Steven J; Karner, Charlotta; Trevor, Nicola; Wakefield, Victoria; Salih, Fatima

2015-08-01

Bradycardia [resting heart rate below 60 beats per minute (b.p.m.)] can be caused by conditions affecting the natural pacemakers of the heart, such as sick sinus syndrome (SSS) and atrioventricular (AV) blocks. People suffering from bradycardia may present with palpitations, exercise intolerance and fainting. The only effective treatment for patients suffering from symptomatic bradycardia is implantation of a permanent pacemaker. To appraise the clinical effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber atrial pacemakers for treating symptomatic bradycardia in people with SSS and no evidence of AV block. All databases (MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Health Technology Assessment database, NHS Economic Evaluations Database) were searched from inception to June 2014. A systematic review of the clinical and economic literature was carried out in accordance with the general principles published by the Centre for Reviews and Dissemination. Randomised controlled trials (RCTs) evaluating dual-chamber and single-chamber atrial pacemakers and economic evaluations were included. Pairwise meta-analysis was carried out. A de novo economic model was developed. Of 493 references, six RCTs were included in the review. The results were predominantly influenced by the largest trial DANPACE. Dual-chamber pacing was associated with a statistically significant reduction in reoperation [odds ratio (OR) 0.48, 95% confidence interval (CI) 0.36 to 0.63] compared with single-chamber atrial pacing. The difference is primarily because of the development of AV block requiring upgrade to a dual-chamber device. The risk of paroxysmal atrial fibrillation was also reduced with dual-chamber pacing compared with single-chamber atrial pacing (OR 0.75, 95% CI 0.59 to 0.96). No statistically significant difference was found between the pacing modes for mortality, heart failure, stroke, chronic atrial fibrillation or quality of life. However, the risk of developing heart failure may vary with age and device. The de novo economic model shows that dual-chamber pacemakers are more expensive and more effective than single-chamber atrial devices, resulting in a base-case incremental cost-effectiveness ratio (ICER) of £6506. The ICER remains below £20,000 in probabilistic sensitivity analysis, structural sensitivity analysis and most scenario analyses and one-way sensitivity analyses. The risk of heart failure may have an impact on the decision to use dual-chamber or single-chamber atrial pacemakers. Results from an analysis based on age (> 75 years or ≤ 75 years) and risk of heart failure indicate that dual-chamber pacemakers dominate single-chamber atrial pacemakers (i.e. are less expensive and more effective) in older patients, whereas dual-chamber pacemakers are dominated by (i.e. more expensive and less effective) single-chamber atrial pacemakers in younger patients. However, these results are based on a subgroup analysis and should be treated with caution. In patients with SSS without evidence of impaired AV conduction, dual-chamber pacemakers appear to be cost-effective compared with single-chamber atrial pacemakers. The risk of developing a complete AV block and the lack of tools to identify patients at high risk of developing the condition argue for the implantation of a dual-chamber pacemaker programmed to minimise unnecessary ventricular pacing. However, considerations have to be made around the risk of developing heart failure, which may depend on age and device. This study is registered as PROSPERO CRD42013006708. The National Institute for Health Research Health Technology Assessment programme.

Cardiac pacing and aviation.

PubMed

Toff, W D; Edhag, O K; Camm, A J

1992-12-01

Certain applicants with stable disturbances of rhythm or conduction requiring cardiac pacing, in whom no other disqualifying condition is present, may be considered fit for medical certification restricted to multi-crew operations. The reliability of modern pacing systems appears adequate to permit restricted certification even in pacemaker dependent subjects except for certain models of pacemakers and leads known to be at increased risk of failure. These are to be avoided. There is little evidence to suggest that newer devices are any more reliable than their predecessors. Single and dual chamber systems appear to have similar reliability up to 4 years, after which time significant attrition of dual chamber devices occurs, principally due to battery depletion. All devices require increased scrutiny as they approach their end of life as predicted from longevity data and pacing characteristics. Unipolar and bipolar leads are of similar reliability, apart from a number of specific bipolar polyurethane leads which have been identified. Atrial leads, particularly those without active fixation, are less secure than ventricular leads and applicants who are dependent on atrial sensing or pacing should be denied certification. Bipolar leads are to be preferred due to the lower risk of myopotential and exogenous EMI. Sensor-driven adaptive-rate pacing systems using active sensors may have reduced longevity and require close scrutiny. Activity-sensing devices using piezoelectric crystal sensors may be subject to significant rate rises in rotary wing aircraft. The impracticality of restricted certification in helicopters will, in any event, preclude certification. Such devices would best be avoided in hovercraft (air cushioned vehicle) pilots. Only minor rate rises are likely in fixed-wing aircraft which are unlikely to be of significance. Anti-tachycardia devices and implanted defibrillators are inconsistent with any form of certification to fly.

Incidence of Cardiac Perforation With Conventional and With Leadless Pacemaker Systems: A Systematic Review and Meta-Analysis.

PubMed

Vamos, Mate; Erath, Julia W; Benz, Alexander P; Bari, Zsolt; Duray, Gabor Z; Hohnloser, Stefan H

2017-03-01

Two leadless pacemaker (PM) systems were recently developed to avoid pocket- and lead-related complications. As leadless PMs are implanted with a large delivery catheter, cardiac perforation remains a major safety concern. We aimed to provide a literature review on incidence of cardiac perforation with conventional and with leadless PM systems. A systematic review over the last 25 years for studies reporting data on PM lead perforation was performed. Findings were synthesized descriptively. Where control groups were available, data were meta-analyzed to identify important clinical risk factors. A total of 28 studies comprising 60,744 patients undergoing conventional PM implantation were analyzed. The incidence of lead perforation ranged from 0% to 6.37% (mean 0.82%, weighted mean 0.31%, median of 0.40%). There was no significant difference in perforation risk between atrial and ventricular electrodes (POR 0.72, 95% confidence interval [CI], 0.28-1.87, P = 0.50) and between MRI conditional and conventional leads (POR 5.93, 95% CI, 0.72-48.76, P = 0.10). The use of active fixation leads (POR 4.25, 95% CI, 1.00-17.95, P = 0.05) and utilization of DDD versus VVI PM systems (POR 3.50, 95% CI, 1.48-8.28, P < 0.01) were associated with higher rates of perforation. In the 2 leadless PM studies, the incidence of cardiac perforation was 1.52% for each. PM lead perforation rates vary in individual studies with an overall low incidence. Leadless PMs seem to be associated with a slightly higher perforation risk, most likely reflecting a learning curve effect of this novel technology. © 2016 Wiley Periodicals, Inc.

Nonlinear metamaterials for electromagnetic energy harvesting (Conference Presentation)

NASA Astrophysics Data System (ADS)

Oumbe Tekam, Gabin Thibaut; Ginis, Vincent; Seetharamdoo, Divitha; Danckaert, Jan

2016-09-01

Surrounded by electromagnetic radiation coming from wireless power transfer to consumer devices such as mobile phones, computers and television, our society is facing the scientific and technological challenge to recover energy that is otherwise lost to the environment. Energy harvesting is an emerging field of research focused on this largely unsolved problem, especially in the microwave regime. Metamaterials provide a very promising platform to meet this purpose. These artificial materials are made from subwavelength building blocks, and can be designed by resonate at particular frequencies, depending on their shape, geometry, size, and orientation. In this work, we show that an efficient electromagnetic energy harvester can be design by inserting a nonlinear element directly within the metamaterial unit cell, leading to the conversion of RF input power to DC charge accumulation. The electromagnetic energy harvester operating at microwave frequencies is built from a cut-wire metasurface, which operates as a quasistatic electric dipole resonator. Using the equivalent electrical circuit, we design the parameters to tune the resonance frequency of the harvester at the desired frequency, and we compare these results with numerical simulations. Finally, we discuss the efficiency of our metamaterial energy harvesters. This work potentially offers a variety of applications, for example in the telecommunications industry to charge phones, in robotics to power microrobots, and also in medicine to advance pacemakers or health monitoring sensors.

The Number of Recalled Leads is Highly Predictive of Lead Failure: Results From the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS").

PubMed

Kersten, Daniel J; Yi, Jinju; Feldman, Alyssa M; Brahmbhatt, Kunal; Asheld, Wilbur J; Germano, Joseph; Islam, Shahidul; Cohen, Todd J

2016-12-01

The purpose of this study was to determine if implantation of multiple recalled defibrillator leads is associated with an increased risk of lead failure. The authors of the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS") have previously reported a relationship between recalled lead status, lead failure, and patient mortality. This substudy analyzes the relationship in a smaller subset of patients who received more than one recalled lead. The specific effects of having one or more recalled leads have not been previously examined. This study analyzed lead failure and mortality of 3802 patients in PAIDLESS and compared outcomes with respect to the number of recalled leads received. PAIDLESS includes all patients at Winthrop University Hospital who underwent defibrillator lead implantation between February 1, 1996 and December 31, 2011. Patients with no recalled ICD leads, one recalled ICD lead, and two recalled ICD leads were compared using the Kaplan-Meier method and log-rank test. Sidak adjustment method was used to correct for multiple comparisons. All calculations were performed using SAS 9.4. P-values <.05 were considered statistically significant. This study included 4078 total ICD leads implanted during the trial period. There were 2400 leads (59%) in the no recalled leads category, 1620 leads (40%) in the one recalled lead category, and 58 leads (1%) in the two recalled leads category. No patient received more than two recalled leads. Of the leads categorized in the two recalled leads group, 12 experienced lead failures (21%), which was significantly higher (P<.001) than in the no recalled leads group (60 failures, 2.5%) and one recalled lead group (81 failures; 5%). Multivariable Cox's regression analysis found a total of six significant predictive variables for lead failure including the number of recalled leads (P<.001 for one and two recalled leads group). The number of recalled leads is highly predictive of lead failure. Lead-based multivariable Cox's regression analysis produced a total of six predictive variable categories for lead failure, one of which was the number of recalled leads. Kaplan-Meier analysis showed that the leads in the two recalled leads category failed faster than both the no recalled lead and one recalled lead groups. The greater the number of recalled leads to which patients are exposed, the greater the risk of lead failure.

Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices.

PubMed

Nazarian, Saman; Hansford, Rozann; Rahsepar, Amir A; Weltin, Valeria; McVeigh, Diana; Gucuk Ipek, Esra; Kwan, Alan; Berger, Ronald D; Calkins, Hugh; Lardo, Albert C; Kraut, Michael A; Kamel, Ihab R; Zimmerman, Stefan L; Halperin, Henry R

2017-12-28

Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed "MRI-conditional" devices). We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter-defibrillator (42%) that was not considered to be MRI-conditional (termed a "legacy" device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients. At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The observed changes in lead parameters were not clinically significant and did not require device revision or reprogramming. We evaluated the safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a legacy pacemaker or a legacy implantable cardioverter-defibrillator system. No long-term clinically significant adverse events were reported. (Funded by Johns Hopkins University and the National Institutes of Health; ClinicalTrials.gov number, NCT01130896 .).

Vascular access for hemodialysis: current perspectives.

PubMed

Santoro, Domenico; Benedetto, Filippo; Mondello, Placido; Pipitò, Narayana; Barillà, David; Spinelli, Francesco; Ricciardi, Carlo Alberto; Cernaro, Valeria; Buemi, Michele

2014-01-01

A well-functioning vascular access (VA) is a mainstay to perform an efficient hemodialysis (HD) procedure. There are three main types of access: native arteriovenous fistula (AVF), arteriovenous graft, and central venous catheter (CVC). AVF, described by Brescia and Cimino, remains the first choice for chronic HD. It is the best access for longevity and has the lowest association with morbidity and mortality, and for this reason AVF use is strongly recommended by guidelines from different countries. Once autogenous options have been exhausted, prosthetic fistulae become the second option of maintenance HD access alternatives. CVCs have become an important adjunct in maintaining patients on HD. The preferable locations for insertion are the internal jugular and femoral veins. The subclavian vein is considered the third choice because of the high risk of thrombosis. Complications associated with CVC insertion range from 5% to 19%. Since an increasing number of patients have implanted pacemakers and defibrillators, usually inserted via the subclavian vein and superior vena cava into the right heart, a careful assessment of risk and benefits should be taken. Infection is responsible for the removal of about 30%-60% of HD CVCs, and hospitalization rates are higher among patients with CVCs than among AVF ones. Proper VA maintenance requires integration of different professionals to create a VA team. This team should include a nephrologist, radiologist, vascular surgeon, infectious disease consultant, and members of the dialysis staff. They should provide their experience in order to give the best options to uremic patients and the best care for their VA.

Pharmacological characterization of ionic currents that regulate high-frequency spontaneous activity of electromotor neurons in the weakly electric fish, Apteronotus leptorhynchus.

PubMed

Smith, G Troy

2006-01-01

The neural circuit that controls the electric organ discharge (EOD) of the brown ghost knifefish (Apteronotus leptorhynchus) contains two spontaneous oscillators. Both pacemaker neurons in the medulla and electromotor neurons (EMNs) in the spinal cord fire spontaneously at frequencies of 500-1,000 Hz to control the EOD. These neurons continue to fire in vitro at frequencies that are highly correlated with in vivo EOD frequency. Previous studies used channel blocking drugs to pharmacologically characterize ionic currents that control high-frequency firing in pacemaker neurons. The goal of the present study was to use similar techniques to investigate ionic currents in EMNs, the other type of spontaneously active neuron in the electromotor circuit. As in pacemaker neurons, high-frequency firing of EMNs was regulated primarily by tetrodotoxin-sensitive sodium currents and by potassium currents that were sensitive to 4-aminopyridine and kappaA-conotoxin SIVA, but resistant to tetraethylammonium. EMNs, however, differed from pacemaker neurons in their sensitivity to some channel blocking drugs. Alpha-dendrotoxin, which blocks a subset of Kv1 potassium channels, increased firing rates in EMNs, but not pacemaker neurons; and the sodium channel blocker muO-conotoxin MrVIA, which reduced firing rates of pacemaker neurons, had no effect on EMNs. These results suggest that similar, but not identical, ionic currents regulate high-frequency firing in EMNs and pacemaker neurons. The differences in the ionic currents expressed in pacemaker neurons and EMNs might be related to differences in the morphology, connectivity, or function of these two cell types.

Neuropeptide secreted from a pacemaker activates neurons to control a rhythmic behavior.

PubMed

Wang, Han; Girskis, Kelly; Janssen, Tom; Chan, Jason P; Dasgupta, Krishnakali; Knowles, James A; Schoofs, Liliane; Sieburth, Derek

2013-05-06

Rhythmic behaviors are driven by endogenous biological clocks in pacemakers, which must reliably transmit timing information to target tissues that execute rhythmic outputs. During the defecation motor program in C. elegans, calcium oscillations in the pacemaker (intestine), which occur about every 50 s, trigger rhythmic enteric muscle contractions through downstream GABAergic neurons that innervate enteric muscles. However, the identity of the timing signal released by the pacemaker and the mechanism underlying the delivery of timing information to the GABAergic neurons are unknown. Here, we show that a neuropeptide-like protein (NLP-40) released by the pacemaker triggers a single rapid calcium transient in the GABAergic neurons during each defecation cycle. We find that mutants lacking nlp-40 have normal pacemaker function, but lack enteric muscle contractions. NLP-40 undergoes calcium-dependent release that is mediated by the calcium sensor, SNT-2/synaptotagmin. We identify AEX-2, the G-protein-coupled receptor on the GABAergic neurons, as the receptor for NLP-40. Functional calcium imaging reveals that NLP-40 and AEX-2/GPCR are both necessary for rhythmic activation of these neurons. Furthermore, acute application of synthetic NLP-40-derived peptide depolarizes the GABAergic neurons in vivo. Our results show that NLP-40 carries the timing information from the pacemaker via calcium-dependent release and delivers it to the GABAergic neurons by instructing their activation. Thus, we propose that rhythmic release of neuropeptides can deliver temporal information from pacemakers to downstream neurons to execute rhythmic behaviors. Copyright © 2013 Elsevier Ltd. All rights reserved.

Evaluation of Death among the Patients Undergoing Permanent Pacemaker Implantation: A Competing Risks Analysis

PubMed Central

GHAEM, Haleh; GHORBANI, Mohammad; ZARE DORNIANI, Samira

2017-01-01

Background: Permanent artificial pacemaker is one of the important therapies for treatment of cardiac conduction system problems. The present study aimed to determine the association between some predictive variables and all-cause and cause-specific mortality in the patients who had undergone pacemaker implantation. Methods: This study was conducted on 1207 patients who had undergone permanent pacemaker implantation in the hospitals affiliated with Shiraz University of Medical Sciences, Iran, from Mar 2002 to Mar 2012. The variables that existed in the patients’ medical records included sex, diabetes mellitus, obesity, cerebrovascular accident, cardiomegaly, smoking, hypertension, ischemic heart disease, congenital heart disease, sick sinus syndrome, and atrial fibrillation. Competing risks model was used to assess the association between the predictive variables and cause-specific (i.e., cardiac and vascular) mortality. Results: The patients’ mean age was 66.32±17.92 yr (70.62±14.45 yr in the patients with single-chamber pacemakers vs. 61.91±17.69 yr in those with two-chamber pacemakers) (P<0.001). Sick sinus syndrome and age increased the risk of all-cause mortality, while two-chamber pacemaker decreased this risk. Obesity increased the risk of cardiac death, and diabetes mellitus and heart valve disease increased the risk of vascular death. Conclusion: The variables predicting mortality in all-cause model were completely different from those in cause-specific model. Moreover, death in such patients may occur due to reasons other than pacemaker. Therefore, future studies, particularly prospective ones, are recommended to use competing risks models. PMID:28828325

SU-E-T-585: Optically-Stimulated Luminescent Dosimeters for Monitoring Pacemaker Dose in Radiation Therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Apicello, L; Riegel, A; Jamshidi, A

2015-06-15

Purpose: A sufficient amount of ionizing radiation can cause failure to components of pacemakers. Studies have shown that permanent damage can occur after a dose of 10 Gy and minor damage to functionality occurs at doses as low as 2 Gy. Optically stimulated thermoluminescent dosimeters (OSLDs) can be used as in vivo dosimeters to predict dose to be deposited throughout the treatment. The purpose of this work is to determine the effectiveness of using OSLDs for in vivo dosimetry of pacemaker dose. Methods: As part of a clinical in vivo dosimetry experience, OSLDs were placed at the site of themore » pacemaker by the therapist for one fraction of the radiation treatment. OSLD measurements were extrapolated to the total dose to be received by the pacemaker during treatment. A total of 79 measurements were collected from November 2011 to December 2013 on six linacs. Sixty-six (66) patients treated in various anatomical sites had the dose of their pacemakers monitored. Results: Of the 79 measurements recorded, 76 measurements (96 %) were below 2 Gy. The mean and standard deviation were 50.12 ± 76.41 cGy. Of the 3 measurements that exceeded 2 Gy, 2 measurements matched the dose predicted in the treatment plan and 1 was repeated after an unexpectedly high Result. The repeated measurement yielded a total dose less than 2 Gy. Conclusion: This analysis suggests OSLDs may be used for in vivo monitoring of pacemaker dose. Further research should be performed to assess the effect of increased backscatter from the pacemaker device.« less

Risk of pacemaker implantation after uneventful successful cavotricuspid isthmus radiofrequency ablation in patients with common atrial flutter.

PubMed

Rodríguez-Mañero, Moisés; González-Melchor, Layla; Ballesteros, Gabriel; Raposeiras-Roubín, Sergio; García-Seara, Javier; López, Xesús Alberte Fernández; Cambeiro, Cristina González; Alcalde, Oscar; García-Bolao, Ignacio; Martínez-Sande, Luis; González-Juanatey, José Ramón

2016-01-01

Little is known about the risk of pacemaker implantation after common atrial flutter ablation in the long-term. We retrospectively reviewed the electrophysiology laboratory database at two Spanish University Hospitals from 1998 to 2012 to identify patients who had undergone successful ablation for cavotricuspid dependent atrial flutter. Cox regression analysis was used to examine the risk of pacemaker implantation. A total of 298 patients were considered eligible for inclusion. The mean age of the enrolled patients was 65.7±11. During 57.7±42.8 months, 30 patients (10.1%) underwent pacemaker implantation. In the stepwise multivariate models only heart rate at the time of the ablation (OR: 0.96; 95% CI: 0.93-0.98; p<0.0001) and intraventricular conduction disturbances in the baseline ECG (OR: 3.87; 95% CI: 1.54-9.70; p=0.004) were independents predictors of the need of pacemaker implantation. A heart rate of ≤65 bpm was identified as the optimal cut-off value to predict the need of pacemaker implantation in the follow-up (sensitivity: 79%, specificity: 74%) by ROC curve analyses. This is the first study of an association between the slow conducting common atrial flutter and subsequent risk of pacemaker implantation. In light of these findings, assessing it prior to ablation can be helpful for the risk stratification of sinus node disease or atrioventricular conduction disease requiring a pacemaker implantation in patients with persistent atrial flutter. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Pacemaker failure resulting from radiation damage

DOE Office of Scientific and Technical Information (OSTI.GOV)

Quertermous, T.; Megahy, M.S.; Das Gupta, D.S.

1983-07-01

The authors present a case of radiation-induced pacemaker failure. After 2000 rad (20 Gy) of photon irradiation for metastatic bronchogenic carcinoma, the pulse generator circuitry failed, producing a runaway rhythm. This suggests that present pacemaker circuitry may be more susceptible to irradiation than previously believed, and that even modest radiation doses can induce life-threatening arrhythmias.

Loeffler endocarditis: silent right ventricular myocardium!

PubMed

Çetin, Süha; Heper, Gülümser; Gökhan Vural, Mustafa; Hazirolan, Tuncay

2016-07-01

We present the case of a 54-year-old male patient with Loeffler endocarditis. It is a rare disorder characterized by fibrous thickening of the endocardium leading to apical obliteration and restrictive cardiomyopathy resulting in heart failure, thromboembolic events or atrial fibrillation. To the best of our knowledge, this is the first case reporting the electrical silence of the right ventricular (RV) apex caused by fibrothrombotic thickening of this area. Under these circumstances RV apical implantation of an implantable cardioverter defibrillator (ICD) or pacemaker electrode may lead to unsuccessful stimulation of these devices.

Electrophysiological performance of a bipolar membrane-coated titanium nitride electrode: a randomized comparison of steroid and nonsteroid lead designs.

PubMed

Wiegand, U K; Zhdanov, A; Stammwitz, E; Crozier, I; Claessens, R J; Meier, J; Bos, R J; Bode, F; Potratz, J

1999-06-01

The aim of this multicenter study was to investigate the performance of a new cardiac pacemaker lead with a titanium nitride cathode coated with a copolymer membrane. In particular, the electrophysiological effect of steroid dissolved in this ion-exchange membrane was evaluated by randomized comparison. Ninety-five patients were randomized either to the 1450 T (n = 51) or the 1451 T ventricular lead (n = 45) and received telemeteral VVI(R) pacemakers with identical diagnostic features. Both leads were bipolar, were passively affixed, and had a porous titanium nitride tip with a surface area of 3.5 mm2. The only difference between the two electrodes was 13 micrograms of dexamethasone added to the 1450 Ts membrane coating. Voltage thresholds (VTH) at pulse durations of 0.25, 0.37, and 0.5 ms, lead impedance, and sensing thresholds were measured at discharge, 2 weeks, 1 month, 3 months, and 6 months after implantation. Mean amplitude and the slew rate from three telemetered intracardiac electrograms, chronaxie-rheobase product, and minimum energy consumption were calculated. After a 6-month follow-up, mean voltage thresholds of 0.65 +/- 0.20 V and 0.63 +/- 0.34 were achieved for the 1450 T lead and 1451 T lead, respectively. As a result, a VTH < 1.0 V was obtained in all patients with 1450 T electrodes and in 97.7% of patients with 1451 T leads after 6 months follow-up. In both electrodes, stable VTH was reached 2 weeks after implantation, and no transient rise in threshold was observed. No differences were observed between the steroid and the nonsteroid group in respect to VTH, chronaxie-rheobase product, minimum energy consumption, and potential amplitude and slew rate. In conclusion, safe and efficient pacing at low pulse amplitudes were achieved with both leads. The tip design, independently of the steroid additive, prevented any energy-consuming increases in the voltage threshold.

Ethics and the cardiac pacemaker: more than just end-of-life issues.

PubMed

Hutchison, Katrina; Sparrow, Robert

2018-05-01

For many years, ethical debate about pacemakers has focused on whether and under what circumstances they may be turned off in end of life care. Several other important ethical issues have been neglected, perhaps because the dilemmas they pose for cardiologists are not so immediate. These include: potential conflicts of interest, particularly those arising from the role of industry employed allied professionals (IEAPs) in pacemaker care; unanticipated impacts of commercial competition and the device improvement cycle; risks associated with remotely accessible software; equity in access to healthcare; and questions about reuse of explanted pacemakers in low and middle income countries. This paper analyses these issues in order to facilitate a more comprehensive approach to ethics and the cardiac pacemaker. Cardiologists should be aware of all of these issues and contribute to ongoing discussions about how they are resolved.

Inductively powered wireless pacing via a miniature pacemaker and remote stimulation control system.

PubMed

Abiri, Parinaz; Abiri, Ahmad; Packard, René R Sevag; Ding, Yichen; Yousefi, Alireza; Ma, Jianguo; Bersohn, Malcolm; Nguyen, Kim-Lien; Markovic, Dejan; Moloudi, Shervin; Hsiai, Tzung K

2017-07-21

Pacemakers have existed for decades as a means to restore cardiac electrical rhythms. However, lead-related complications have remained a clinical challenge. While market-released leadless devices have addressed some of the issues, their pacer-integrated batteries cause new health risks and functional limitations. Inductive power transfer enables wireless powering of bioelectronic devices; however, Specific Absorption Rate and size limitations reduce power efficiency for biomedical applications. We designed a remote-controlled system in which power requirements were significantly reduced via intermittent power transfer to control stimulation intervals. In parallel, the cardiac component was miniaturized to facilitate intravascular deployment into the anterior cardiac vein. Given size constraints, efficiency was optimal via a circular receiver coil wrapped into a half-cylinder with a meandering tail. The pacemaker was epicardially tested in a euthanized pig at 60 beats per minute, 2 V amplitude, and 1 ms pulse width, restoring mean arterial pressure from 0 to 37 mmHg. Power consumption was 1 mW at a range of > 3 cm with no misalignment and at 2 cm with 45° displacement misalignment, 45° x-axis angular misalignment, or 45° y-axis angular misalignment. Thus, we demonstrated a remote-controlled miniaturized pacing system with low power consumption, thereby providing a basis for the next generation of wireless implantable devices.

The incidence of blood contamination of lead unit dose containers with and without single-use protective inserts used with commercially prepared radiopharmaceutical unit doses.

PubMed

Pickett, M W; Kosegi, J E; Thomas, K S; Waterstram-Rich, K M

1998-09-01

This investigation evaluated the effectiveness of disposable plastic inserts in radiopharmaceutical unit dose lead containers (pigs) in preventing the distribution of doses in blood-contaminated containers. Technologists commonly dispose of the syringes by placing them into the lead pigs, leaving the needles uncapped. This process raises the question of unsuspected blood contamination of these pigs. Consequently, the distribution of commercially prepared radiopharmaceutical doses in reusable lead pigs may result in radiopharmaceutical doses being distributed in containers that are contaminated with blood. Using a simple chemical wipe test designed to determine the presence or absence of blood contamination, 618 pigs from commercial radiopharmacies throughout the U.S. were tested for contamination. The inside of the pigs and inserts, if present, were wiped before and after dose administration. Of the pigs tested, 292 came from radiopharmacies that used a protective, disposable plastic insert inside the pig, and 326 came from radiopharmacies that did not use an insert. Of those pigs without the protective disposable inserts, 39.3% arrived in the nuclear medicine department in pigs contaminated with blood. Of those pigs with inserts, 1% arrived with blood-contaminated inserts. After dose administration, 46.3% of the pigs without inserts were contaminated with blood and 3% of the protective inserts were contaminated. The proper use of disposable plastic inserts reduces the possibility of distributing radiopharmaceutical unit doses in containers contaminated with blood.

The Mechanism of Action of Zingerone in the Pacemaker Potentials of Interstitial Cells of Cajal Isolated from Murine Small Intestine.

PubMed

Kim, Jung Nam; Kim, Hyun Jung; Kim, Iksung; Kim, Yun Tai; Kim, Byung Joo

2018-01-01

Zingerone, a major component found in ginger root, is clinically effective for the treatment of various diseases. Interstitial cells of Cajal (ICCs) are the pacemaker cells responsible for slow waves in the gastrointestinal (GI) tract. We investigated the effects of zingerone on the pacemaker potentials of ICCs to assess its mechanisms of action and its potential as a treatment for GI tract motility disorder. We isolated ICCs from small intestines, and the whole-cell patch-clamp configuration was used to record the pacemaker potentials in cultured ICCs. Under the current clamping mode, zingerone inhibited pacemaker potentials of ICCs concentration-dependently. These effects were blocked not by capsazepine, a transient receptor potential vanilloid 1 (TRPV1) channel blocker, but by glibenclamide, a specific ATP-sensitive K+ channel blocker. Pretreatment with SQ-22536 (an adenylate cyclase inhibitor), LY294002 (a phosphoinositide 3-kinase inhibitor), and calphostin C (a protein kinase C (PKC) inhibitor) did not block the effects of zingerone on the pacemaker potentials relative to treatment with zingerone alone. However, zingerone-induced pacemaker potential inhibition was blocked by 1H-[1,2,4] oxadiazolo [4,3-a] quinoxalin-1-one (ODQ; a guanylate cyclase inhibitor), KT5823 (a protein kinase G (PKG) inhibitor), and L-NAME (a non-selective nitric oxide synthase (NOS) inhibitor). In addition, zingerone stimulated cyclic guanosine monophosphate (cGMP) production in ICCs. Finally, pretreatment with PD98059 (a p42/44 mitogen-activated protein kinase (MAPK) inhibitor), SB203580 (a p38 MAPK inhibitor), and SP600125 (c-Jun N-terminal kinases (JNK)-specific inhibitor) blocked the zingerone-induced pacemaker potential inhibition. These results suggest that zingerone concentration-dependently inhibits pacemaker potentials of ICCs via NO/cGMP-dependent ATP-sensitive K+ channels through MAPK-dependent pathways. Taken together, this study shows that zingerone may have the potential for development as a GI regulation agent. © 2018 The Author(s). Published by S. Karger AG, Basel.

Successful pacing using a batteryless sunlight-powered pacemaker.

PubMed

Haeberlin, Andreas; Zurbuchen, Adrian; Schaerer, Jakob; Wagner, Joerg; Walpen, Sébastien; Huber, Christoph; Haeberlin, Heinrich; Fuhrer, Juerg; Vogel, Rolf

2014-10-01

Today's cardiac pacemakers are powered by batteries with limited energy capacity. As the battery's lifetime ends, the pacemaker needs to be replaced. This surgical re-intervention is costly and bears the risk of complications. Thus, a pacemaker without primary batteries is desirable. The goal of this study was to test whether transcutaneous solar light could power a pacemaker. We used a three-step approach to investigate the feasibility of sunlight-powered cardiac pacing. First, the harvestable power was estimated. Theoretically, a subcutaneously implanted 1 cm(2) solar module may harvest ∼2500 µW from sunlight (3 mm implantation depth). Secondly, ex vivo measurements were performed with solar cells placed under pig skin flaps exposed to a solar simulator and real sunlight. Ex vivo measurements under real sunlight resulted in a median output power of 4941 µW/cm(2) [interquartile range (IQR) 3767-5598 µW/cm(2), median skin flap thickness 3.0 mm (IQR 2.7-3.3 mm)]. The output power strongly depended on implantation depth (ρSpearman = -0.86, P < 0.001). Finally, a batteryless single-chamber pacemaker powered by a 3.24 cm(2) solar module was implanted in vivo in a pig to measure output power and to pace. In vivo measurements showed a median output power of >3500 µW/cm(2) (skin flap thickness 2.8-3.84 mm). Successful batteryless VVI pacing using a subcutaneously implanted solar module was performed. Based on our results, we estimate that a few minutes of direct sunlight (irradiating an implanted solar module) allow powering a pacemaker for 24 h using a suitable energy storage. Thus, powering a pacemaker by sunlight is feasible and may be an alternative energy supply for tomorrow's pacemakers. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

Feasibility and safety of adenosine cardiovascular magnetic resonance in patients with MR conditional pacemaker systems at 1.5 Tesla.

PubMed

Klein-Wiele, Oliver; Garmer, Marietta; Urbien, Rhyan; Busch, Martin; Kara, Kaffer; Mateiescu, Serban; Grönemeyer, Dietrich; Schulte-Hermes, Michael; Garbrecht, Marc; Hailer, Birgit

2015-12-22

Cardiovascular Magnetic Resonance (CMR) with adenosine stress is a valuable diagnostic tool in coronary artery disease (CAD). However, despite the development of MR conditional pacemakers CMR is not yet established in clinical routine for pacemaker patients with known or suspected CAD. A possible reason is that adenosine stress perfusion for ischemia detection in CMR has not been studied in patients with cardiac conduction disease requiring pacemaker therapy. Other than under resting conditions it is unclear whether MR safe pacing modes (paused pacing or asynchronous mode) can be applied safely because the effect of adenosine on heart rate is not precisely known in this entity of patients. We investigate for the first time feasibility and safety of adenosine stress CMR in pacemaker patients in clinical routine and evaluate a pacing protocol that considers heart rate changes under adenosine. We retrospectively analyzed CMR scans of 24 consecutive patients with MR conditional pacemakers (mean age 72.1 ± 11.0 years) who underwent CMR in clinical routine for the evaluation of known or suspected CAD. MR protocol included cine imaging, adenosine stress perfusion and late gadolinium enhancement. Pacemaker indications were sinus node dysfunction (n = 18) and second or third degree AV block (n = 6). Under a pacing protocol intended to avoid competitive pacing on the one hand and bradycardia due to AV block on the other no arrhythmia occurred. Pacemaker stimulation was paused to prevent competitive pacing in sinus node dysfunction with resting heart rate >45 bpm. Sympatho-excitatory effect of adenosine led to a significant acceleration of heart rate by 12.3 ± 8.3 bpm (p < 0.001), no bradycardia occurred. On the contrary in AV block heart rate remained constant; asynchronous pacing above resting heart rate did not interfere with intrinsic rhythm. Adenosine stress CMR appears to be feasible and safe in patients with MR conditional pacemakers. Heart rate response to adenosine has to be considered for the choice of pacing modes during CMR.

Management and outcome of topical beta-blockerinduced atrioventricular block

PubMed Central

Özcan, Kazım Serhan; Güngör, Barış; Tekkeşin, Ahmet İlker; Altay, Servet; Ekmekçi, Ahmet; Toprak, Ercan; Yıldırım, Ersin; Çalık, Nazmi; Alper, Ahmet Taha; Gürkan, Kadir; Erdinler, İzzet; Osmonov, Damirbek

2015-01-01

Summary Background Topical beta-blockers have a well-established role in the treatment of glaucoma. We aimed to investigate the outcome of patients who developed symptomatic atrioventricular (AV) block induced by topical beta-blockers. Methods All patients admitted or discharged from our institution, the Siyami Ersek Training and Research Hospital, between January 2009 and January 2013 with a diagnosis of AV block were included in the study. Subjects using ophthalmic beta-blockers were recruited and followed for permanent pacemaker requirement during hospitalisation and for three months after discontinuation of the drug. A permanent pacemaker was implanted in patients in whom AV block persisted beyond 72 hours or recurred during the follow-up period. Results A total of 1 122 patients were hospitalised with a diagnosis of AV block and a permanent pacemaker was implanted in 946 cases (84.3%) during the study period. Thirteen patients using ophthalmic beta-blockers for the treatment of glaucoma and no other rate-limiting drugs were included in the study. On electrocardiography, eight patients had complete AV block and five had high-degree AV block. The ophthalmic beta-blockers used were timolol in seven patients (55%), betaxolol in four (30%), and cartelol in two cases (15%). The mean duration of ophthalmic beta-blocker treatment was 30.1 ± 15.9 months. After drug discontinuation, in 10 patients the block persisted and a permanent pacemaker was implanted. During follow up, one more patient required pacemaker implantation. Therefore in total, pacemakers were implanted in 11 out of 13 patients (84.6%). The pacemaker implantation rate did not differ according to the type of topical beta-blocker used (p = 0.37). The presence of infra-nodal block on electrocardiography was associated with higher rates of pacemaker implantation. Conclusion Our results indicate that topical beta-blockers for the treatment of glaucoma may cause severe conduction abnormalities and when AV block occurs, pacemaker implantation is required in a high percentage of the patients. PMID:26659434

[Temporary Pacemakers - Step by Step].

PubMed

Graf, Matthias; Stiller, Patrick; Karch, Martin

2018-06-01

Symptomatic bradycardia is usually caused by abnormalities of atrioventricular conduction or sinus node dysfunction. Reversible and irreversible causes must be considered.Temporary pacemakers are used in the emergency treatment in case of severe bradyarrhythmia.They help to bridge the acute phase until spontaneous restoration of atrioventricular or sinus node function or -if spontaneous restoration fails- until a permanent pacemaker system was implanted.In the following article we discuss the commonly used temporary pacemaker systems. We demonstrate their use and correct programming by an illustrated step by step explanation. For troubleshooting a flow chart was added. © Georg Thieme Verlag KG Stuttgart · New York.

3D echocardiographic location of implantable device leads and mechanism of associated tricuspid regurgitation.

PubMed

Mediratta, Anuj; Addetia, Karima; Yamat, Megan; Moss, Joshua D; Nayak, Hemal M; Burke, Martin C; Weinert, Lynn; Maffessanti, Francesco; Jeevanandam, Valluvan; Mor-Avi, Victor; Lang, Roberto M

2014-04-01

This study sought to: 1) determine the feasibility of using 3-dimensional transthoracic echocardiography (3D TTE) in patients with implantable cardiac resynchronization devices, pacemakers, and defibrillators to visualize the device leads in the right heart and their position relative to the tricuspid valve leaflets; 2) determine the prevalence of different lead positions; and 3) study the relationship between lead location and tricuspid regurgitation (TR) severity. Pacemaker, defibrillator, and cardiac resynchronization device implantation is currently guided by fluoroscopy, not allowing targeted lead positioning relative to the tricuspid valve leaflets. These leads have been reported to cause TR of variable degrees, but echocardiography is not routinely used to elucidate the mechanisms of lead interference with tricuspid valve leaflets in individual patients. 3D TTE full-volume images of the right ventricle and/or zoomed images of the tricuspid valve were obtained in 121 patients with implanted devices. Images were viewed offline to determine the position of the device-lead relative to the tricuspid valve leaflets. Severity of TR was estimated on the basis of vena contracta measurements. 3D TTE clearly depicted lead position in 90% of patients. The right ventricular lead was impinging on either the posterior (20%) or septal (23%) leaflet or was not interfering with leaflet motion (53%) when positioned near the posteroseptal commissure or in the central portion of the tricuspid valve orifice. In the remaining patients, leads were impinging on the anterior leaflet (4%) or positioned in either the anteroposterior or anteroseptal commissure (3%). Leads interfering with normal leaflet mobility were associated with more TR than nonimpinging leads (vena contracta: median 0.62 cm [1st and 3rd quartiles: 0.51, 0.84 cm] vs. 0.27 cm [1st and 3rd quartiles: 0.00, 0.48 cm]; p < 0.001). 3D TTE showed a clear association between device lead position and TR. To minimize TR induced by device-leads, 3D TTE guidance should be considered for placement in a commissural position. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Pacemaker rate and depolarization block in nigral dopamine neurons: a somatic sodium channel balancing act

PubMed Central

Tucker, Kristal R.; Huertas, Marco A.; Horn, John P.; Canavier, Carmen C.; Levitan, Edwin S.

2012-01-01

Midbrain dopamine (DA) neurons are slow intrinsic pacemakers that undergo depolarization (DP) block upon moderate stimulation. Understanding DP block is important because it has been correlated with the clinical efficacy of chronic antipsychotic drug treatment. Here we describe how voltage-gated sodium (NaV) channels regulate DP block and pacemaker activity in DA neurons of the substantia nigra using rat brain slices. The distribution, density and gating of NaV currents were manipulated by blocking native channels with tetrodotoxin and by creating virtual channels and anti-channels with dynamic clamp. Although action potentials initiate in the axon initial segment (AIS) and NaV channels are distributed in multiple dendrites, selective reduction of NaV channel activity in the soma was sufficient to decrease pacemaker frequency and increase susceptibility to DP block. Conversely, increasing somatic NaV current density raised pacemaker frequency and lowered susceptibility to DP block. Finally, when NaV currents were restricted to the soma, pacemaker activity occurred at abnormally high rates due to excessive local subthreshold NaV current. Together with computational simulations, these data show that both the slow pacemaker rate and the sensitivity to DP block that characterizes DA neurons result from the low density of somatic NaV channels. More generally, we conclude that the somatodendritic distribution of NaV channels is a major determinant of repetitive spiking frequency. PMID:23077037

A pacemaker powered by an implantable biofuel cell operating under conditions mimicking the human blood circulatory system--battery not included.

PubMed

Southcott, Mark; MacVittie, Kevin; Halámek, Jan; Halámková, Lenka; Jemison, William D; Lobel, Robert; Katz, Evgeny

2013-05-07

Biocatalytic electrodes made of buckypaper were modified with PQQ-dependent glucose dehydrogenase on the anode and with laccase on the cathode and were assembled in a flow biofuel cell filled with serum solution mimicking the human blood circulatory system. The biofuel cell generated an open circuitry voltage, Voc, of ca. 470 mV and a short circuitry current, Isc, of ca. 5 mA (a current density of 0.83 mA cm(-2)). The power generated by the implantable biofuel cell was used to activate a pacemaker connected to the cell via a charge pump and a DC-DC converter interface circuit to adjust the voltage produced by the biofuel cell to the value required by the pacemaker. The voltage-current dependencies were analyzed for the biofuel cell connected to an Ohmic load and to the electronic loads composed of the interface circuit, or the power converter, and the pacemaker to study their operation. The correct pacemaker operation was confirmed using a medical device - an implantable loop recorder. Sustainable operation of the pacemaker was achieved with the system closely mimicking human physiological conditions using a single biofuel cell. This first demonstration of the pacemaker activated by the physiologically produced electrical energy shows promise for future electronic implantable medical devices powered by electricity harvested from the human body.

Adaptations in Locus Coeruleus Induced by Post-Traumatic Stress Disorder

DTIC Science & Technology

2013-11-01

optogenetics, channelrhodopsin-2, fear conditioning, pacemaking , calcium, synaptic plasticity, corticotropin-releasing factor (CRF), endoplasmic...neurons revealed tonic, pacemaking activity was accompanied by an underlying membrane potential oscillation that was sensitive to the dihydropyridine...prominent, opening of these channels was not necessary to sustain normal pacemaking at rest. However, these channels help support LC spiking during

How smart should pacemakers Be?

PubMed

Saoudi, N; Appl, U; Anselme, F; Voglimacci, M; Cribier, A

1999-03-11

The concept of the "smart" pacemaker has been continuously changing during 40 years of progress in technology. When we talk today about smart pacemakers, it means optimal treatment, diagnosis, and follow-up for patients fitting the current indications for pacemakers. So what is smart today becomes accepted as "state of the art" tomorrow. Originally, implantable pacemakers were developed to save lives from prolonged episodes of bradycardia and/or complete heart block. Now, in addition, they improve quality of life via numerous different functions acting under specific conditions, thanks to the introduction of microprocessors. The devices have become smaller, with the miniaturization of the electrical components, without compromising longevity. Nevertheless, there are still some unmatched objectives for these devices, for example, the optimization of cardiac output and the management of atrial arrhythmias in dual-chamber devices. Furthermore, indications continue to evolve, which in turn require new, additional functions. These functions are often very complex, necessitating computerized programming to simplify application. In addition, the follow-up of these devices is time-consuming, as appropriate system performance has to be regularly monitored. A great many of these functions could be automatically performed and documented, thus enabling physicians and paramedical staff to avoid losing time with routine control procedures. In addition, modern pacemakers offer extensive diagnostic functions to help diagnose patient symptoms and pacemaker system problems. Different types of data are available, and their presentation differs from one company to the other. This huge amount of data can only be managed with automatic diagnostic functions. Thus, the smart pacemaker of the near future should offer high flexibility to permit easy programming of available therapies and follow-up, and extensive, easily comprehensible diagnostic functions.

The Circadian Neuropeptide PDF Signals Preferentially through a Specific Adenylate Cyclase Isoform AC3 in M Pacemakers of Drosophila

PubMed Central

Duvall, Laura B.; Taghert, Paul H.

2012-01-01

The neuropeptide Pigment Dispersing Factor (PDF) is essential for normal circadian function in Drosophila. It synchronizes the phases of M pacemakers, while in E pacemakers it decelerates their cycling and supports their amplitude. The PDF receptor (PDF-R) is present in both M and subsets of E cells. Activation of PDF-R stimulates cAMP increases in vitro and in M cells in vivo. The present study asks: What is the identity of downstream signaling components that are associated with PDF receptor in specific circadian pacemaker neurons? Using live imaging of intact fly brains and transgenic RNAi, we show that adenylate cyclase AC3 underlies PDF signaling in M cells. Genetic disruptions of AC3 specifically disrupt PDF responses: they do not affect other Gs-coupled GPCR signaling in M cells, they can be rescued, and they do not represent developmental alterations. Knockdown of the Drosophila AKAP-like scaffolding protein Nervy also reduces PDF responses. Flies with AC3 alterations show behavioral syndromes consistent with known roles of M pacemakers as mediated by PDF. Surprisingly, disruption of AC3 does not alter PDF responses in E cells—the PDF-R(+) LNd. Within M pacemakers, PDF-R couples preferentially to a single AC, but PDF-R association with a different AC(s) is needed to explain PDF signaling in the E pacemakers. Thus critical pathways of circadian synchronization are mediated by highly specific second messenger components. These findings support a hypothesis that PDF signaling components within target cells are sequestered into “circadian signalosomes,” whose compositions differ between E and M pacemaker cell types. PMID:22679392

The circadian neuropeptide PDF signals preferentially through a specific adenylate cyclase isoform AC3 in M pacemakers of Drosophila.

PubMed

Duvall, Laura B; Taghert, Paul H

2012-01-01

The neuropeptide Pigment Dispersing Factor (PDF) is essential for normal circadian function in Drosophila. It synchronizes the phases of M pacemakers, while in E pacemakers it decelerates their cycling and supports their amplitude. The PDF receptor (PDF-R) is present in both M and subsets of E cells. Activation of PDF-R stimulates cAMP increases in vitro and in M cells in vivo. The present study asks: What is the identity of downstream signaling components that are associated with PDF receptor in specific circadian pacemaker neurons? Using live imaging of intact fly brains and transgenic RNAi, we show that adenylate cyclase AC3 underlies PDF signaling in M cells. Genetic disruptions of AC3 specifically disrupt PDF responses: they do not affect other Gs-coupled GPCR signaling in M cells, they can be rescued, and they do not represent developmental alterations. Knockdown of the Drosophila AKAP-like scaffolding protein Nervy also reduces PDF responses. Flies with AC3 alterations show behavioral syndromes consistent with known roles of M pacemakers as mediated by PDF. Surprisingly, disruption of AC3 does not alter PDF responses in E cells--the PDF-R(+) LNd. Within M pacemakers, PDF-R couples preferentially to a single AC, but PDF-R association with a different AC(s) is needed to explain PDF signaling in the E pacemakers. Thus critical pathways of circadian synchronization are mediated by highly specific second messenger components. These findings support a hypothesis that PDF signaling components within target cells are sequestered into "circadian signalosomes," whose compositions differ between E and M pacemaker cell types.

Enrichment of cardiac pacemaker-like cells: neuregulin-1 and cyclic AMP increase I(f)-current density and connexin 40 mRNA levels in fetal cardiomyocytes.

PubMed

Ruhparwar, Arjang; Er, Fikret; Martin, Ulrich; Radke, Kristin; Gruh, Ina; Niehaus, Michael; Karck, Matthias; Haverich, Axel; Hoppe, Uta C

2007-02-01

Generation of a large number of cells belonging to the cardiac pacemaker system would constitute an important step towards their utilization as a biological cardiac pacemaker system. The aim of the present study was to identify factors, which might induce transformation of a heterogenous population of fetal cardiomyocytes into cells with a pacemaker-like phenotype. Neuregulin-1 (alpha- and beta-isoform) or the cAMP was added to fresh cell cultures of murine embryonic cardiomyocytes. Quantitative northern blot analysis and flowcytometry were performed to detect the expression of connexins 40, 43 and 45. Patch clamp recordings in the whole cell configuration were performed to determine current density of I (f), a characteristic ion current of pacemaker cells. Fetal cardiomyocytes without supplement of neuregulin or cAMP served as control group. Neuregulin and cAMP significantly increased mRNA levels of connexin 40 (Cx-40), a marker of the early differentiating conduction system in mice. On the protein level, flowcytometry revealed no significant differences between treated and untreated groups with regard to the expression of connexins 40, 43 and 45. Treatment with cAMP (11.2 +/- 2.24 pA/pF; P < 0.001) and neuregulin-1-beta (6.23 +/- 1.07 pA/pF; P < 0.001) significantly increased the pacemaker current density compared to control cardiomyocytes (1.76 +/- 0.49 pA/pF). Our results indicate that neuregulin-1 and cAMP possess the capacity to cause significant transformation of a mixed population of fetal cardiomyocytes into cardiac pacemaker-like cells as shown by electrophysiology and increase of Cx-40 mRNA. This method may allow the development of a biological cardiac pacemaker system when applied to adult or embryonic stem cells.

Long-Term Mortality Effect of Early Pacemaker Implantation After Surgical Aortic Valve Replacement.

PubMed

Greason, Kevin L; Lahr, Brian D; Stulak, John M; Cha, Yong-Mei; Rea, Robert F; Schaff, Hartzell V; Dearani, Joseph A

2017-10-01

The need for pacemaker implantation is a well-described complication of aortic valve replacement. Not so well described is the effect such an event has on long-term outcome. This study reviewed a 21-year experience at the Mayo Clinic (Rochester, Minnesota) with aortic valve replacement to understand the influence of early postoperative pacemaker implantation on long-term mortality rates more clearly. This study retrospectively reviewed the records of 5,842 patients without previous pacemaker implantation who underwent surgical aortic valve replacement from January 1993 through June 2014. The median age of these patients was 73 years (range, 65 to 79 years), the median ejection fraction was 62% (range, 53% to 68%), 3,853 patients were male (66%), and coronary artery bypass graft operation was performed in 2,553 (44%) of the patients studied. Early pacemaker implantation occurred in 146 patients (2.5%) within 30 days of surgical aortic valve replacement. The median follow-up of patients was 11.1 years (range, 5.8 to 16.5 years), and all-cause mortality rates were 2.4% at 30 days, 6.4% at 1 year, 23.1% at 5 years, 48.3% at 10 years, and 67.9% at 15 years postoperatively. Early pacemaker implantation was associated with an increased risk of death after multivariable adjustment for baseline patients' characteristics (hazard ratio, 1.49; 95% confidence interval, 1.20, 1.84; p < 0.001). Early pacemaker implantation as a complication of surgical aortic valve replacement is associated with an increased risk of long-term death. Valve replacement-related pacemaker implantation rates should be important considerations with respect to new valve replacement paradigms, especially in younger and lower-risk patients. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Late Outcome and Predictors of Adverse Events Related to the Implantation of a Permanent Pacemaker in Patients with Isolated Congenital Atrioventricular Block.

PubMed

de Oliveira, Grasiele Bess; de Oliveira, Fábio Silveira; Osório, Ana Paula Susin; Medeiros, Alexandre Kreling; Sant'anna, João Ricardo Michielin; Leiria, Tiago Luiz Luz

2016-10-01

Isolated congenital atrioventricular block (ICAVB) is a rare, and pacemaker implantation is the only effective treatment. We sought to identify the predictive factors of adverse events related to pacemaker implantation in ICAVB. This is a cohort study of patients diagnosed with ICAVB who underwent pacemaker implantation from 1980 to 2014 in a single center. During the studied period, a total of 647 patients underwent implantation of their first permanent cardiac pacemaker before 30 years of age. Of these, only 62 (9.5 %) were diagnosed with ICAVB. This condition was diagnosed in utero in 15 (24.2 %) cases, 5 (8.1 %) in the neonatal period, 32 (51.6 %) during childhood, and 10 (16.1 %) during adolescence and young adulthood. The presence of autoantibodies (anti-Ro/SSA) was observed in 41 % of mothers who underwent serological evaluation. Age at the time of the initial pacemaker implant was 9.8 ± 9 years. During a mean follow-up time of 15 years, 1 (1.7 %) death occurred due to infectious endocarditis. Complications related to pacemaker implant were reported in 24 patients (38.7 %). The number of complications was significantly higher in the group with an epimyocardial implantation site (HR 6; CI 2.45-14.95). Ventricular dysfunction occurred in 6 (11.7 %) patients; however, we were not able to identify any predictors of it. Our results showed a low mortality rate after permanent therapy. However, these patients exhibited high morbidity related to the pacemaker system, and the epimyocardial implant site was an independent predictor of complications. Predictors of left ventricular dysfunction were not found in the present study.

Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers.

PubMed

Crossley, George H; Chen, Jane; Choucair, Wassim; Cohen, Todd J; Gohn, Douglas C; Johnson, W Ben; Kennedy, Eleanor E; Mongeon, Luc R; Serwer, Gerald A; Qiao, Hongyan; Wilkoff, Bruce L

2009-11-24

The purpose of this study was to evaluate remote pacemaker interrogation for the earlier diagnosis of clinically actionable events compared with traditional transtelephonic monitoring and routine in-person evaluation. Pacemaker patient follow-up procedures have evolved from evaluating devices with little programmability and diagnostic information solely in person to transtelephonic rhythm strip recordings that allow monitoring of basic device function. More recently developed remote monitoring technology leverages expanded device capabilities, augmenting traditional transtelephonic monitoring to evaluate patients via full device interrogation. The time to first diagnosis of a clinically actionable event was compared in patients who were followed by remote interrogation (Remote) and those who were followed per standard of care with office visits augmented by transtelephonic monitoring (Control). Patients were randomized 2:1. Remote arm patients transmitted pacemaker information at 3-month intervals. Control arm patients with a single-chamber pacemaker transmitted at 2-month intervals. Control arm patients with dual-chamber devices transmitted at 2-month intervals with an office visit at 6 months. All patients were seen in office at 12 months. The mean time to first diagnosis of clinically actionable events was earlier in the Remote arm (5.7 months) than in the Control arm (7.7 months). Three (2%) of the 190 events in the Control arm and 446 (66%) of 676 events in the Remote arm were identified remotely. The strategic use of remote pacemaker interrogation follow-up detects actionable events that are potentially important more quickly and more frequently than transtelephonic rhythm strip recordings. The use of transtelephonic rhythm strips for pacemaker follow-up is of little value except for battery status determinations. (PREFER [Pacemaker Remote Follow-up Evaluation and Review]; NCT00294645).

Programmable Pacemaker

NASA Technical Reports Server (NTRS)

1996-01-01

Released in 1995, the Trilogy cardiac pacemaker is the fourth generation of a unit developed in the 1970s by NASA, Johns Hopkins Applied Physics Laboratory and St. Jude Medical's Cardiac Rhythm Management Division (formerly known as Pacesetter Systems, Inc.). The new system incorporates the company's PDx diagnostic and programming software and a powerful microprocessor that allows more functions to be fully automatic and gives more detailed information on the patient's health and the performance of the pacing systems. The pacemaker incorporates bidirectional telemetry used for space communications for noninvasive communication with the implanted pacemaker, smaller implantable pulse generators from space microminiaturization, and longer-life batteries from technology for spacecraft electrical power systems.

Lithium-cupric sulfide cell

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cuesta, A.J.; Bump, D.D.

1980-01-01

Lithium cells have become the primary power source for cardiac pacemakers due to their reliability and longevity at low current drain rates. A lithium-cupric sulfide cell was developed which makes maximum use of the shape of a pacemaker's battery compartment. The cell has a stable voltage throughout 90% of its lifetime. It then drops to a second stable voltage before depletion. The voltage drop creates a small decrease in pacemaker rate, which alerts the physician to replace the pacemaker. No loss of capacity due to self-discharge as been seen to date, and cells have proven to be safe under extrememore » conditions. 2 refs.« less

Role of sinoatrial node architecture in maintaining a balanced source-sink relationship and synchronous cardiac pacemaking

PubMed Central

Unudurthi, Sathya D.; Wolf, Roseanne M.; Hund, Thomas J.

2014-01-01

Normal heart rhythm (sinus rhythm) depends on regular activity of the sinoatrial node (SAN), a heterogeneous collection of specialized myocytes in the right atrium. SAN cells, in general, possess a unique electrophysiological profile that promotes spontaneous electrical activity (automaticity). However, while automaticity is required for normal pacemaking, it is not necessarily sufficient. Less appreciated is the importance of the elaborate structure of the SAN complex for proper pacemaker function. Here, we review the important structural features of the SAN with a focus on how these elements help manage a precarious balance between electrical charge generated by the SAN (“source”) and the charge needed to excite the surrounding atrial tissue (“sink”). We also discuss how compromised “source-sink” balance due, for example to fibrosis, may promote SAN dysfunction, characterized by slow and/or asynchronous pacemaker activity and even failure, in the setting of cardiovascular disease (e.g., heart failure, atrial fibrillation). Finally, we discuss implications of the “source-sink” balance in the SAN complex for cell and gene therapies aimed at creating a biological pacemaker as replacement or bridge to conventional electronic pacemakers. PMID:25505419

Embryological development of pacemaker hierarchy and membrane currents related to the function of the adult sinus node: implications for autonomic modulation of biopacemakers.

PubMed

Opthof, Tobias

2007-02-01

The sinus node is an inhomogeneous structure. In the embryonic heart all myocytes have sinus node type pacemaker channels (I (f)) in their sarcolemma. Shortly before birth, these channels disappear from the ventricular myocytes. The response of the adult sinus node to changes in the interstitium, in particular to (neuro)transmitters, results from the interplay between the responses of all of its constituent cells. The response of the whole sinus node cannot be simply deduced from these cellular responses, because all cells have different responses to specific agonists. A biological pacemaker will be more homogeneous. Therefore it can be anticipated that tuning of cycle length may be problematic. It is discussed that efforts to create a biological pacemaker responsive to vagal stimulation, may be counterproductive, because it may have the potential risk of 'standstill' of the biological pacemaker. A normal sinus node remains spontaneously active at high concentrations of acetylcholine, because it has areas that are unresponsive to acetylcholine. The same is pertinent to other substances with a negative chronotropic effect. Such functional inhomogeneity is lacking in biological pacemakers.

Implantable automatic scanning pacemaker for termination of supraventricular tachycardia.

PubMed

Spurrell, R A; Nathan, A W; Bexton, R S; Hellestrand, K J; Nappholz, T; Camm, A J

1982-03-01

Thirteen patients suffering from reentrant supraventricular tachycardia have undergone implantation of a scanning extrastimulus pacemaker. This pacemaker is fully implanted and automatic, and it requires no external control device to activate or control it. The pacemaker is activated when tachycardia occurs. After four cycles an extrastimulus is induced with a preset coupling time from a sensed intracardiac potential, and every four cycles thereafter a further extrastimulus occurs, but on each occasion there is a decrement in coupling cycle by 6 ms until 90 ms of the cardiac cycle has been scanned by extrastimuli. When necessary, two extrastimuli can be introduced with a fixed but preset coupling time between them. Every four beats two extrastimuli are induced but the coupling time between the spontaneous cardiac potential and the first stimulus is decreased by 6 ms until 90 ms of the cardiac cycle has been scanned. The coupling time between the two stimuli is fixed throughout the scan. When termination of tachycardia occurs the successful timing variables are retained in the pacemaker memory so that at the onset of the next episode of tachycardia these settings are used first. Pacemaker pulse width, sensitivity, tachycardia trigger rate, coupling intervals for both stimuli and the use of single or double extrastimuli are all programmable transcutaneously. Three patients required single, and seven patients double ventricular premature stimuli; three patients required double atrial premature stimuli for termination of tachycardia. Despite frequent attacks of tachycardia before implantation, only two patients had a sustained attack of tachycardia after pacemaker implantation.

Angiotensin II promotes differentiation of mouse c-kit-positive cardiac stem cells into pacemaker-like cells

PubMed Central

XUE, CHENG; ZHANG, JUN; LV, ZHAN; LIU, HUI; HUANG, CONGXIN; YANG, JING; WANG, TEN

2015-01-01

Cardiac stem cells (CSCs) can differentiate into cardiac muscle-like cells; however, it remains unknown whether CSCs may possess the ability to differentiate into pacemaker cells. The aim of the present study was to determine whether angiotensin II (Ang II) could promote the specialization of CSCs into pacemaker-like cells. Mouse CSCs were treated with Ang II from day 3–5, after cell sorting. The differentiation potential of the cells was then analyzed by morphological analysis, flow cytometry, reverse transcription-polymerase chain reaction, immunohistochemistry and patch clamp analysis. Treatment with Ang II resulted in an increased number of cardiac muscle-like cells (32.7±4.8% vs. 21.5±4.8%; P<0.05), and inhibition of smooth muscle-like cells (6.2±7.3% vs. 20.5±5.1%; P<0.05). Following treatment with Ang II, increased levels of the cardiac progenitor-specific markers GATA4 and Nkx2.5 were observed in the cells. Furthermore, the transcript levels of pacemaker function-related genes, including hyperpolarization-activated cyclic nucleotide-gated (HCN)2, HCN4, T-box (Tbx)2 and Tbx3, were significantly upregulated. Immunofluorescence analysis confirmed the increased number of pacemaker-like cells. The pacemaker current (If) was recorded in the cells derived from CSCs, treated with Ang II. In conclusion, treatment of CSCs with Ang II during the differentiation process modified cardiac-specific gene expression and resulted in the enhanced formation of pacemaker-like cells. PMID:25572000

Radioisotope-powered cardiac pacemaker program. Clinical studies of the nuclear pacemaker model NU-5. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1980-06-01

Beginning in February, 1970, the Nuclear Materials and Equipment Corporation (NUMEC) undertook a program to design, develop and manufacture a radioisotope powered cardiac pacemaker system. The scope of technical work was specified to be: establish system, component, and process cost reduction goals using the prototype Radioisotope Powered Cardiac Pacemaker (RCP) design and develop production techniques to achieve these cost reduction objectives; fabricate radioisotope powered fueled prototype cardiac pacemakers (RCP's) on a pilot production basis; conduct liaison with a Government-designated fueling facility for purposes of defining fueling requirements, fabrication and encapsulation procedures, safety design criteria and quality control and inspection requirements;more » develop and implement Quality Assurance and Reliability Programs; conduct performance, acceptance, lifetime and reliability tests of fueled RCP's in the laboratory; conduct liaison with the National Institutes of Health and with Government specified medical research institutions selected for the purpose of undertaking clinical evaluation of the RCP in humans; monitor and evaluate, on a continuing basis, all test data; and perform necessary safety analyses and tests. Pacemaker designs were developed and quality assurance and manufacturing procedures established. Prototype pacemakers were fabricated. A total of 126 radioisotope powered units were implanted and have been followed clinically for approximately seven years. Four (4) of these units have failed. Eighty-three (83) units remain implanted and satisfactorily operational. An overall failure rate of less than the target 0.15% per month has been achieved.« less

Pacemaker implantation after catheter ablation for atrial fibrillation.

PubMed

Deshmukh, Abhishek J; Yao, Xiaoxi; Schilz, Stephanie; Van Houten, Holly; Sangaralingham, Lindsey R; Asirvatham, Samuel J; Friedman, Paul A; Packer, Douglas L; Noseworthy, Peter A

2016-01-01

Sinus node dysfunction requiring pacemaker implantation is commonly associated with atrial fibrillation (AF), but may not be clinically apparent until restoration of sinus rhythm with ablation or cardioversion. We sought to determine frequency, time course, and predictors for pacemaker implantation after catheter ablation, and to compare the overall rates to a matched cardioversion cohort. We conducted a retrospective analysis using a large US commercial insurance database and identified 12,158 AF patients who underwent catheter ablation between January 1, 2005 and December 31, 2012. Over an average of 2.4 years of follow-up, 5.6 % of the patients underwent pacemaker implantation. Using the Cox proportional hazards models, we found that risk of risks of pacemaker implantation was associated with older age (50-64 and ≥65 versus <50 years), female gender, higher CHADS2 score (≥2 and 1 versus 0), higher Charlson index (≥2 versus 0-1), certain baseline comorbidities (conduction disorder, coronary atherosclerosis, and congestive heart failure), and the year of ablation. There was no significant difference in the risk of pacemaker implantation between ablation patients and propensity score (PS)-matched cardioversion groups (3.5 versus. 4.1 % at 1 year and 8.8 versus 8.3 % at 5 years). Overall, pacemaker implantation occurs in about 1/28 patients within 1 year of catheter ablation. The overall implantation rate decreased between 2005 and 2012. Furthermore, the risk after ablation is similar to cardioversion, suggesting that patients require pacing due to a common underlying electrophysiologic substrate, rather than the ablation itself.

Characteristics and Prognosis of Pacemaker-Identified New-Onset Atrial Fibrillation in Japanese People.

PubMed

Ogino, Yutaka; Ishikawa, Toshiyuki; Ishigami, Tomoaki; Matsumoto, Katsumi; Hosoda, Junya; Iguchi, Kouhei; Matsushita, Hirooki; Taguchi, Yuka; Horiguchi, Yoriko; Kimura, Kazuo

2017-05-25

The characteristics and prognosis of implanted pacemaker-identified new-onset atrial fibrillation (AF) in Japanese people has not been well evaluated.Methods and Results:A total of 395 consecutive patients with newly implanted pacemakers were retrospectively analyzed between January 2010 and December 2015 at Yokohama City University Hospital. Patients with a prior history of AF, VVI mode pacemaker, congenital heart disease, severe valvular heart disease, and cardiovascular surgery before pacemaker implantation were excluded. Among the remaining patients, 44 (21.3%) developed new AF during follow-up (mean follow-up, 1,115±651 days; range, 9-2,176 days). Patients with new-onset AF had a significantly higher CHADS 2 score (2.09±1.27 vs. 1.31±1.08, P<0.001) and CHA 2 DS 2 -VASc score (3.00±1.39 vs. 2.26±1.19, P<0.001) compared with those without new-onset AF. On Cox regression analysis only age at implantation was significantly correlated with new-onset AF. Interestingly, the incidence of hospitalization due to heart failure was significantly higher in the new-onset AF than in the without new-onset AF group. A total of 21.3% of pacemaker-implanted patients with high CHADS 2 and CHA 2 DS 2 -VASc scores developed new-onset AF during a mean follow-up of 3.1 years; and pacemaker-identified AF was associated with an increased risk of worsening heart failure.

Genetic Elimination of GABAergic Neurotransmission Reveals Two Distinct Pacemakers for Spontaneous Waves of Activity in the Developing Mouse Cortex

PubMed Central

Easton, Curtis R.; Weir, Keiko; Scott, Adina; Moen, Samantha P.; Barger, Zeke; Folch, Albert; Hevner, Robert F.

2014-01-01

Many structures of the mammalian CNS generate propagating waves of electrical activity early in development. These waves are essential to CNS development, mediating a variety of developmental processes, such as axonal outgrowth and pathfinding, synaptogenesis, and the maturation of ion channel and receptor properties. In the mouse cerebral cortex, waves of activity occur between embryonic day 18 and postnatal day 8 and originate in pacemaker circuits in the septal nucleus and the piriform cortex. Here we show that genetic knock-out of the major synthetic enzyme for GABA, GAD67, selectively eliminates the picrotoxin-sensitive fraction of these waves. The waves that remain in the GAD67 knock-out have a much higher probability of propagating into the dorsal neocortex, as do the picrotoxin-resistant fraction of waves in controls. Field potential recordings at the point of wave initiation reveal different electrical signatures for GABAergic and glutamatergic waves. These data indicate that: (1) there are separate GABAergic and glutamatergic pacemaker circuits within the piriform cortex, each of which can initiate waves of activity; (2) the glutamatergic pacemaker initiates waves that preferentially propagate into the neocortex; and (3) the initial appearance of the glutamatergic pacemaker does not require preceding GABAergic waves. In the absence of GAD67, the electrical activity underlying glutamatergic waves shows greatly increased tendency to burst, indicating that GABAergic inputs inhibit the glutamatergic pacemaker, even at stages when GABAergic pacemaker circuitry can itself initiate waves. PMID:24623764

Pacemaker Implants in Children and Adolescents with Chagas Disease in Brazil: 18-Year Incidence

PubMed Central

Mizzaci, Carolina Christianini; Souza, Thiago Gonçalves Schroder e; Targueta, Gabriel Pelegrineti; Tótora, Ana Paula Frederico; Mateos, Juan Carlos Pachón; Mateos, José Carlos Pachon

2017-01-01

Background: Chagas disease continues to be a serious public health problem, and accounts for 25-30% of the indications for cardiac stimulation in Brazil. Objective: To assess clinical and epidemiological characteristics of patients with Chagas disease, younger than 18 years, who had undergone pacemaker implantation in Brazil between 1994 and 2011, and its temporal trend. Methods: This was a cross-sectional analysis of data from the Brazilian Pacemaker Registry database. The following variables were analyzed: year when pacemaker was implanted, location, age, sex, ethnic group, functional class and the main electrocardiographic findings at baseline. Results: In a total of 183,123 implants performed between 1994 and 2011, 214 implants of cardiac stimulation device in Chagas disease patients aged younger than 18 years were identified. Mean age at implantation was 5.6 ± 6.2 years. Second- and third-degree atrioventricular blocks corresponded to 71% of indications for pacemaker implantation. Fifty-six percent of the procedures were performed in the southeast region. Regarding the total number of pacemaker implants per year, there was a remarkable increase in the implants for all causes. However, time series analysis of the implants in Chagas disease patients younger than 18 years revealed a significant reduction in the annual number of implants. Conclusion: There has been an important reduction in the number of pacemaker implantations among children and adolescents with Chagas disease, suggesting a reduction in the vertical transmission of the parasite. PMID:28699977

Antibiotic prophylaxis in permanent pacemaker implantation: a prospective randomised trial.

PubMed Central

Mounsey, J P; Griffith, M J; Tynan, M; Gould, F K; MacDermott, A F; Gold, R G; Bexton, R S

1994-01-01

BACKGROUND--Pacemaker pocket infection is a potentially serious problem after permanent pacemaker implantation. Antibiotic prophylaxis is commonly prescribed to reduce the incidence of this complication, but current trial evidence of its efficacy is conflicting. A large prospective randomised trial was therefore performed of antibiotic prophylaxis in permanent pacemaker implantation. The intention was firstly to determine whether antibiotic prophylaxis is efficacious in these patients and secondly to identify which patients are at the highest risk of infection. METHODS--A prospective randomised open trial of flucloxacillin (clindamycin if the patient was allergic to penicillin) v no antibiotic was performed in a cohort of patients undergoing first implantation of a permanent pacing system over a 17 month period. Intravenous antibiotics were started at the time of implantation and continued for 48 hours. The trial endpoint was a repeat operation for an infective complication. RESULTS--473 patients were entered into a randomised trial. 224 received antibiotic prophylaxis and 249 received no antibiotics. A further 183 patients were not randomised but were treated according to the operator's preference (64 antibiotics, 119 no antibiotics); these patients are included only in the analysis of predictors of infection. Patients were followed up for a mean (SD) of 19(5) months. Among the patients in the randomised group there were nine infections requiring a repeat operation, all in the group not receiving antibiotic (P = 0.003). In the total patient cohort there were 13 infections, all but one in the non-antibiotic group (P = 0.006). Nine of the infections presented as erosion of the pulse generator or electrode, three as septicaemia secondary to Staphylococcus aureus, and one as a pocket abscess secondary to Staphylococcus epidermidis. Infections were significantly more common when the operator was inexperienced (< or = 100 previous patients), the operation was prolonged, or after a repeat operation for non-infective complications (principally lead displacement). Infection was not significantly more common in patients identified preoperatively as being at high risk (for example patients with diabetes mellitus, patients receiving long term steroid treatment), although there was a trend in this direction. CONCLUSIONS--Antibiotic prophylaxis significantly reduced the incidence of infective complications requiring a repeat operation after permanent pacemaker implantation. It is suggested that antibiotics should be used routinely. PMID:7833191

Prevalence and clinical significance of left bundle branch block according to classical or strict definition criteria in permanent pacemaker patients.

PubMed

Mazza, Andrea; Bendini, Maria Grazia; De Cristofaro, Raffaele; Lovecchio, Mariolina; Valsecchi, Sergio; Leggio, Massimo; Boriani, Giuseppe

2017-06-01

Previous studies have shown that the presence of left bundle branch block (LBBB) is associated with an increased risk of cardiac mortality and heart failure (HF). Recently, new criteria to define strict LBBB have been proposed: QRS duration ≥140 ms for men and ≥130 ms for women, along with mid-QRS notching or slurring in ≥2 contiguous leads. We assessed the prevalence and prognostic significance of LBBB according to classical (QRS duration ≥120ms) and strict criteria in permanent pacemaker patients. We retrospectively enrolled 723 consecutive patients who had undergone single- or dual-chamber pacemaker implantation at the study center from July 2002 to December 2014. Patients with a left ventricular ejection fraction ≤35% or a prior diagnosis of HF were excluded. LBBB was reported in 54 (7%) patients, and strict-LBBB in 15 (2%) patients. During a median follow-up of 48 months (range, 18-92 months), 147 (20%) patients reached the combined endpoint of death or HF hospitalization. Patients with LBBB and those with strict-LBBB displayed significantly higher rates of death or HF hospitalization (log-rank test, all P < 0.0001). In particular, strict-LBBB was associated with the worst outcome. The presence of LBBB according to classical definition criteria (hazard ratio [HR] = 1.98, confidence interval [CI]: 1.23-3.19, P = 0.005) and to strict criteria (HR = 2.20; CI: 1.04-4.65; P = 0.039) were both confirmed as independent predictors of death or HF hospitalization after adjustment for relevant clinical covariates. Among patients who had undergone standard pacemaker implantation, the prevalence of LBBB was 7% according to classical definition criteria and 2% according to strict criteria. The presence of LBBB, and particularly of strict-LBBB, at the baseline predicted a poor outcome in terms of death or HF hospitalization. © 2017 Wiley Periodicals, Inc.

Clinical features and changes in epidemiology of infective endocarditis on pacemaker devices over a 27-year period (1987-2013).

PubMed

Carrasco, Francisco; Anguita, Manuel; Ruiz, Martín; Castillo, Juan Carlos; Delgado, Mónica; Mesa, Dolores; Romo, Elias; Pan, Manuel; Suárez de Lezo, Jose

2016-06-01

Use of cardiac pacing devices has grown in recent years. Our aim was to evaluate changes in epidemiology and clinical features of infective endocarditis (IE) involving pacemaker devices in a large series of IE over the last 27 years (1987-2013). From 1987 to December 2013, 413 consecutive IE cases were diagnosed in our hospital. During this period, 7424 pacemaker devices were implanted (6917 pacemakers, 239 implantable cardiac defibrillators, 158 resynchronization devices, and 110 resynchronization/defibrillator devices). All consecutive cases of IE on pacemaker devices were included and analysed. Infective endocarditis on pacemaker devices represented 6.1% of all endocarditis cases (25 patients), affecting 3.6/1000 of all implanted pacemakers. Its proportion increased from 1.25% of all endocarditis in 1987-1993 to 4.08% in 1994-2000, 7.69% in 2001-2007 and 9.32% in 2008-2013 (P < 0.01). Its incidence also increased from 1.4/1000 of all pacemaker implants in the period of 1987-1993 to 2.5/1000 in 1994-2000, 3.3/1000 in 2001-2007 and 4.5/1000 implanted devices in 2008-2013 (P < 0.05). Mean age of patients was 68 years, and 80% were male. Causative microorganisms predominantly were Staphylococci (84%: Staphylococcus aureus 48%, Staphylococcus epidermidis 36%). Rate of severe complications was high: persistent sepsis in 60% of cases, heart failure in 20%, and stroke in 12%. Device was removed in 19 patients (76%), mostly by surgery (18 of the 19 cases). Early mortality was 24% (33% of medically, 21% of surgically treated patients, P = 0.82). Infective endocarditis on pacemaker devices has shown an increasing incidence during the past decades, representing almost 10% of all IE in the last 6 years. This is a severe disease, with a high rate of severe complications and requiring removal of device in most cases. In spite of therapy, early mortality is high. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Predicting the risk of sudden cardiac death.

PubMed

Lerma, Claudia; Glass, Leon

2016-05-01

Sudden cardiac death (SCD) is the result of a change of cardiac activity from normal (typically sinus) rhythm to a rhythm that does not pump adequate blood to the brain. The most common rhythms leading to SCD are ventricular tachycardia (VT) or ventricular fibrillation (VF). These result from an accelerated ventricular pacemaker or ventricular reentrant waves. Despite significant efforts to develop accurate predictors for the risk of SCD, current methods for risk stratification still need to be improved. In this article we briefly review current approaches to risk stratification. Then we discuss the mathematical basis for dynamical transitions (called bifurcations) that may lead to VT and VF. One mechanism for transition to VT or VF involves a perturbation by a premature ventricular complex (PVC) during sinus rhythm. We describe the main mechanisms of PVCs (reentry, independent pacemakers and abnormal depolarizations). An emerging approach to risk stratification for SCD involves the development of individualized dynamical models of a patient based on measured anatomy and physiology. Careful analysis and modelling of dynamics of ventricular arrhythmia on an individual basis will be essential in order to improve risk stratification for SCD and to lay a foundation for personalized (precision) medicine in cardiology. © 2015 The Authors. The Journal of Physiology © 2015 The Physiological Society.

Preliminary findings on the safety of 1.5 and 3 Tesla magnetic resonance imaging in cardiac pacemaker patients.

PubMed

van Dijk, Vincent F; Delnoy, Peter Paul H M; Smit, Jaap Jan J; Ramdat Misier, R Anand; Elvan, Arif; van Es, H Wouter; Rensing, Benno J W M; Raciti, Giovanni; Boersma, Lucas V A

2017-07-01

Modern pacemakers are designed to allow patients to undergo magnetic resonance imaging (MRI) under a set of specific conditions. Aim of this study is to provide confirmatory evidence of safety and performance of a new pacing system (ImageReady™, Boston Scientific) in patients undergoing 1.5 and 3T MRI. Two prospective, nonrandomized, single-arm studies were designed to provide confirmatory data of no impact of MRI on device function, lead parameters, and patient conditions in subjects implanted with the system undergoing a clinically non-indicated 1.5T and 3T MRI, respectively. Device measurements were done within 1 hour before and after the scan and at 1 month follow-up. Thirty-two subjects underwent MRI visit (17 subjects with 1.5T MRI and 15 subjects with 3T MRI). There were no unanticipated adverse effects related to the pacemaker. Device measurements taken pre- and post-MRI scan did not show any clinical relevant change that could indicate an effect of the MRI on the device or at the lead-tissue interface (RV threshold change: 0.01 ± 0.13 V, P = 0.60; RA threshold change: 0.01 ± 0.11 V, P = 0.53; R wave change: -0.44 ± 1.73 mV, P = 0.36; R wave change: 0.12 ± 1.67 mV, P = 0.73), with data confirmed at 1-month follow-up visit. The study documented safety of the pacing system in the 1.5T and 3T MRI environment by showing no adverse events related to device or MRI scan. Additional data are required to cover the more complex scenarios involving different diagnostic needs, conditions of use, clinical conditions, and new emerging technologies. © 2017 Wiley Periodicals, Inc.

Implementation and reimbursement of remote monitoring for cardiac implantable electronic devices in Europe: a survey from the health economics committee of the European Heart Rhythm Association.

PubMed

Mairesse, Georges H; Braunschweig, Frieder; Klersy, Katherine; Cowie, Martin R; Leyva, Francisco

2015-05-01

Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) permits early detection of arrhythmias, device, and lead failure and may also be useful in risk-predicting patient-related outcomes. Financial benefits for patients and healthcare organizations have also been shown. We sought to assess the implementation and funding of RM of CIEDs, including conventional pacemakers (PMs), implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices in Europe. Electronic survey from 43 centres in 15 European countries. In the study sample, RM was available in 22% of PM patients, 74% of ICD patients, and 69% of CRT patients. The most significant perceived benefits were the early detection of atrial arrhythmias in pacemaker patients, lead failure in ICD patients, and worsening heart failure in CRT patients. Remote monitoring was reported to lead a reduction of in-office follow-ups for all devices. The most important reported barrier to the implementation of RM for all CIEDs was lack of reimbursement (80% of centres). Physicians regard RM of CIEDs as a clinically useful technology that affords significant benefits for patients and healthcare organizations. Remote monitoring, however, is perceived as increasing workload. Reimbursement for RM is generally perceived as a major barrier to implementation. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Western tropical Pacific multidecadal variability forced by the Atlantic multidecadal oscillation

NASA Astrophysics Data System (ADS)

Kucharski, F.; Sun, C.; Li, J.; Jin, F. F.; Kang, I. S.; Ding, R.

2017-12-01

Observational analysis suggests that the western tropical Pacific (WTP) sea surface temperature (SST) shows predominant variability over multidecadal time scales, which is unlikely to be explained by the Interdecadal Pacific Oscillation. Here we show that this variability is largely explained by the remote Atlantic multidecadal oscillation (AMO). A suite of Atlantic Pacemaker experiments successfully reproduces the WTP multidecadal variability and the AMO-WTP SST connection. The AMO warm SST anomaly generates an atmospheric teleconnection to the North Pacific, which weakens the Aleutian low and subtropical North Pacific westerlies. The wind changes induce a subtropical North Pacific SST warming through wind-evaporation-SST effect, and in response to this warming, the surface winds converge towards the subtropical North Pacific from the tropics, leading to anomalous cyclonic circulation and low pressure over the WTP region. The warm SST anomaly further develops due to the SST-sea level pressure-cloud-longwave radiation positive feedback. Our findings suggest that the Atlantic Ocean acts as a key pacemaker for the western Pacific decadal climate variability.

Western tropical Pacific multidecadal variability forced by the Atlantic multidecadal oscillation

PubMed Central

Sun, Cheng; Kucharski, Fred; Li, Jianping; Jin, Fei-Fei; Kang, In-Sik; Ding, Ruiqiang

2017-01-01

Observational analysis suggests that the western tropical Pacific (WTP) sea surface temperature (SST) shows predominant variability over multidecadal time scales, which is unlikely to be explained by the Interdecadal Pacific Oscillation. Here we show that this variability is largely explained by the remote Atlantic multidecadal oscillation (AMO). A suite of Atlantic Pacemaker experiments successfully reproduces the WTP multidecadal variability and the AMO–WTP SST connection. The AMO warm SST anomaly generates an atmospheric teleconnection to the North Pacific, which weakens the Aleutian low and subtropical North Pacific westerlies. The wind changes induce a subtropical North Pacific SST warming through wind–evaporation–SST effect, and in response to this warming, the surface winds converge towards the subtropical North Pacific from the tropics, leading to anomalous cyclonic circulation and low pressure over the WTP region. The warm SST anomaly further develops due to the SST–sea level pressure–cloud–longwave radiation positive feedback. Our findings suggest that the Atlantic Ocean acts as a key pacemaker for the western Pacific decadal climate variability. PMID:28685765

Circadian rhythms in healthy aging--effects downstream from the pacemaker

NASA Technical Reports Server (NTRS)

Monk, T. H.; Kupfer, D. J.

2000-01-01

Using both previously published findings and entirely new data, we present evidence in support of the argument that the circadian dysfunction of advancing age in the healthy human is primarily one of failing to transduce the circadian signal from the circadian timing system (CTS) to rhythms "downstream" from the pacemaker rather than one of failing to generate the circadian signal itself. Two downstream rhythms are considered: subjective alertness and objective performance. For subjective alertness, we show that in both normal nychthemeral (24 h routine, sleeping at night) and unmasking (36 h of constant wakeful bed rest) conditions, advancing age, especially in men, leads to flattening of subjective alertness rhythms, even when circadian temperature rhythms are relatively robust. For objective performance, an unmasking experiment involving manual dexterity, visual search, and visual vigilance tasks was used to demonstrate that the relationship between temperature and performance is strong in the young, but not in older subjects (and especially not in older men).

Western tropical Pacific multidecadal variability forced by the Atlantic multidecadal oscillation

NASA Astrophysics Data System (ADS)

Sun, Cheng; Kucharski, Fred; Li, Jianping; Jin, Fei-Fei; Kang, In-Sik; Ding, Ruiqiang

2017-07-01

Observational analysis suggests that the western tropical Pacific (WTP) sea surface temperature (SST) shows predominant variability over multidecadal time scales, which is unlikely to be explained by the Interdecadal Pacific Oscillation. Here we show that this variability is largely explained by the remote Atlantic multidecadal oscillation (AMO). A suite of Atlantic Pacemaker experiments successfully reproduces the WTP multidecadal variability and the AMO-WTP SST connection. The AMO warm SST anomaly generates an atmospheric teleconnection to the North Pacific, which weakens the Aleutian low and subtropical North Pacific westerlies. The wind changes induce a subtropical North Pacific SST warming through wind-evaporation-SST effect, and in response to this warming, the surface winds converge towards the subtropical North Pacific from the tropics, leading to anomalous cyclonic circulation and low pressure over the WTP region. The warm SST anomaly further develops due to the SST-sea level pressure-cloud-longwave radiation positive feedback. Our findings suggest that the Atlantic Ocean acts as a key pacemaker for the western Pacific decadal climate variability.

A Sodium Leak Current Regulates Pacemaker Activity of Adult Central Pattern Generator Neurons in Lymnaea Stagnalis

PubMed Central

Lu, Tom Z.; Feng, Zhong-Ping

2011-01-01

The resting membrane potential of the pacemaker neurons is one of the essential mechanisms underlying rhythm generation. In this study, we described the biophysical properties of an uncharacterized channel (U-type channel) and investigated the role of the channel in the rhythmic activity of a respiratory pacemaker neuron and the respiratory behaviour in adult freshwater snail Lymnaea stagnalis. Our results show that the channel conducts an inward leak current carried by Na+ (ILeak-Na). The ILeak-Na contributed to the resting membrane potential and was required for maintaining rhythmic action potential bursting activity of the identified pacemaker RPeD1 neurons. Partial knockdown of the U-type channel suppressed the aerial respiratory behaviour of the adult snail in vivo. These findings identified the Na+ leak conductance via the U-type channel, likely a NALCN-like channel, as one of the fundamental mechanisms regulating rhythm activity of pacemaker neurons and respiratory behaviour in adult animals. PMID:21526173

Right heart failure due to loss of right ventricular capture in a patient with atrioventricular junction ablation and biventricular pacing.

PubMed

Raffa, Santi; Fantoni, Cecilia; Restauri, Luigia; Auricchio, Angelo

2005-10-01

We describe the case of a patient with atrioventricular (AV) junction ablation and chronic biventricular pacing in which intermittent dysfunction of the right ventricular (RV) lead resulted in left ventricular (LV) stimulation alone and onset of severe right heart failure. Restoration of biventricular pacing by increasing device output and then performing lead revision resolved the issue. This case provides evidence that LV pacing alone in patients with AV junction ablation may lead to severe right heart failure, most likely as a result of iatrogenic mechanical dyssynchrony within the RV. Thus, probably this pacing mode should be avoided in pacemaker-dependent patients with heart failure.

Mangalith: a new lithium pacemaker battery

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gerbier, G.; Lehmann, G.

1980-01-01

An original lithium battery system is being developed for pacemaker application. The material used, lithium-manganese dioxide, industrially available at the present time for a variety of electronic applications, has been modified and adapted for pacemaker power requirements. The utilization of a different modification of manganese dioxide offers performance advantages. The cell technology is described and performance comparisons between this new cathode material and the industrial counterpart are reported. 7 refs.

Venous obstruction in permanent pacemaker patients: an isotopic study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pauletti, M.; Di Ricco, G.; Solfanelli, S.

1981-01-01

Isotope venography was used to study the venous circulation proximal to the superior vena cava in two groups of pacemaker patients, one with a single endocavitary electrode and the other with multiple pacing catheters. A control group of patients without pacemakers was also studied. Numerous abnormalities were found, especially in the group with multiple electrodes. These findings suggest that venous obstruction is a common complication of endocardial pacing.

The neurochemical basis of photic entrainment of the circadian pacemaker

NASA Technical Reports Server (NTRS)

Rea, Michael A.; Buckley, Becky; Lutton, Lewis M.

1992-01-01

Circadian rhythmicity in mammals is controlled by the action of a light-entrainable hypothalamus, in association with two cell clusters known as the supra chiasmatic nuclei (SCN). In the absence of temporal environmental clues, this pacemaker continues to measure time by an endogenous mechanism (clock), driving biochemical, physiological, and behavioral rhythms that reflect the natural period of the pacemaker oscillation. This endogenous period usually differs slightly from 24 hours (i.e., circadian). When mammals are maintained under a 24 hour light-dark (LD) cycle, the pacemaker becomes entrained such that the period of the pacemaker oscillation matches that of the LD cycle. Potentially entraining photic information is conveyed to the SCN via a direct retinal projection, the retinohypothalamic tract (RHT). RHT neurotransmission is thought to be mediated by the release of excitatory amino acids (EAA) in the SCN. In support of this hypothesis, recent experiments using nocturnal rodents have shown that EAA antagonists block the effects of light on pacemaker-driven behavioral rhythms, and attenuate light induced gene expression in SCN cells. An understanding of the neurochemical basis of the photic entrainment process would facilitate the development of pharmacological strategies for maintaining synchrony among shift workers in environments, such as the Space Station, which provide unreliable or conflicting temporal photic clues.

Safety of Laser Interstitial Thermal Therapy in Patients With Pacemakers.

PubMed

Grewal, Sanjeet S; Gorny, Krzysztof R; Favazza, Christopher P; Watson, Robert E; Kaufmann, Timothy J; Van Gompel, Jamie J

2018-02-10

Laser interstitial thermal therapy (LiTT) has increasingly been used as a treatment option for medically refractory epilepsy, tumors, and radiation necrosis. The use of LiTT requires intraoperative magnetic resonance (MR) thermography. This can become an issue in patients with other implanted therapeutic devices such as pacemakers and vagal nerve stimulators due to concerns regarding increases in the specific absorption rate (SAR). This is a technical case report demonstrating a successfully and safely performed LiTT in a 1.5-T magnetic resonance imaging (MRI) in a patient with a pacemaker for mesial temporal sclerosis. An 83-yr-old gentleman who had an implanted cardiac pacemaker presented with medically intractable epilepsy and was confirmed to have mesial temporal sclerosis on imaging. Video electroencephalography demonstrated concordant ipsilateral seizures and semiology. He underwent LiTT for ablation of the mesial temporal lobe. This was performed with the below described protocol with a cardiology nurse monitoring the patient's cardiac condition and a physicist monitoring SAR, and MR imaging quality without any adverse events. This study reports on a protocol of cardiac and MR SAR to safely perform MR-guided LiTT in the setting of traditional pacemakers in patients who are not pacemaker dependent. Copyright © 2018 by the Congress of Neurological Surgeons

CaV3.1 is a tremor rhythm pacemaker in the inferior olive

PubMed Central

Park, Young-Gyun; Park, Hye-Yeon; Lee, C. Justin; Choi, Soonwook; Jo, Seonmi; Choi, Hansol; Kim, Yang-Hann; Shin, Hee-Sup; Llinas, Rodolfo R.; Kim, Daesoo

2010-01-01

The rhythmic motor pathway activation by pacemaker neurons or circuits in the brain has been proposed as the mechanism for the timing of motor coordination, and the abnormal potentiation of this mechanism may lead to a pathological tremor. Here, we show that the potentiation of CaV3.1 T-type Ca2+ channels in the inferior olive contributes to the onset of the tremor in a pharmacological model of essential tremor. After administration of harmaline, 4- to 10-Hz synchronous neuronal activities arose from the IO and then propagated to cerebellar motor circuits in wild-type mice, but those rhythmic activities were absent in mice lacking CaV3.1 gene. Intracellular recordings in brain-stem slices revealed that the CaV3.1-deficient inferior olive neurons lacked the subthreshold oscillation of membrane potentials and failed to trigger 4- to 10-Hz rhythmic burst discharges in the presence of harmaline. In addition, the selective knockdown of CaV3.1 gene in the inferior olive by shRNA efficiently suppressed the harmaline-induced tremor in wild-type mice. A mathematical model constructed based on data obtained from patch-clamping experiments indicated that harmaline could efficiently potentiate CaV3.1 channels by changing voltage-dependent responsiveness in the hyperpolarizing direction. Thus, CaV3.1 is a molecular pacemaker substrate for intrinsic neuronal oscillations of inferior olive neurons, and the potentiation of this mechanism can be considered as a pathological cause of essential tremor. PMID:20498062

Potential environmental effects of 765-kV transmission lines: views before the New York State Public Service Commission, Cases 26529 and 26559, 1976-1978

DOE Office of Scientific and Technical Information (OSTI.GOV)

Scott-Walton, B.; Clark, K. M.; Holt, B. R.

1979-11-01

Testimony given before the New York Public Service Commission in two recent cases on the potential environmental effects of 765-kV overhead ac transmission lines is reviewed. The testimony focused on the potential effects of audible noise, on the potential biological effects of the electromagnetic fields, on the potential for electric shocks to people who touch vehicles parked under the proposed lines, on the potential effects of the electromagnetic fields on electronic cardiac pacemakers, and on potential effects of ozone produced by corona discharge from the lines. The testimony fully explored these questions; however, it did not resolve all of them.more » The testimony indicates potential impacts from the audible noise and from the electrostatic shocks that people can receive when they touch a large vehicle parked under the lines. The testimony also indicates that certain cardiac pacemaker and lead combinations may, under certain circumstances, undergo reversion to a fixed rate of pacing in the presence of the fields under the lines, but that little risk to cardiac patients results except possibly for those patients for whom competition between the heart's own rate and the pacemaker rate presents a health risk. The testimony fails to demonstrate biological hazards from the field; further research is necessary to understand better the effects of the fields on biological systems. The testimony indicates that ozone produced by the lines will not significantly affect the environment.« less

Effects of lubiprostone on pacemaker activity of interstitial cells of cajal from the mouse colon.

PubMed

Jiao, Han-Yi; Kim, Dong Hyun; Ki, Jung Suk; Ryu, Kwon Ho; Choi, Seok; Jun, Jae Yeoul

2014-08-01

Lubiprostone is a chloride (Cl(-)) channel activator derived from prostaglandin E1 and used for managing constipation. In addition, lubiprostone affects the activity of gastrointestinal smooth muscles. Interstitial cells of Cajal (ICCs) are pacemaker cells that generate slow-wave activity in smooth muscles. We studied the effects of lubiprostone on the pacemaker potentials of colonic ICCs. We used the whole-cell patch-clamp technique to determine the pacemaker activity in cultured colonic ICCs obtained from mice. Lubiprostone hyperpolarized the membrane and inhibited the generation of pacemaker potentials. Prostanoid EP1, EP2, EP3, and EP4 antagonists (SC-19220, PF-04418948, 6-methoxypyridine-2-boronc acid N-phenyldiethanolamine ester, and GW627368, respectively) did not block the response to lubiprostone. L-NG-nitroarginine methyl ester (L-NAME, an inhibitor of nitric oxide synthase) and 1H-[1,2,4]oxadiazolo[4,3,-a]quinoxalin-1-one (ODQ, an inhibitor of guanylate cyclase) did not block the response to lubiprostone. In addition, tetraethylammonium (TEA, a voltage-dependent potassium [K(+)] channel blocker) and apamin (a calcium [Ca(2+)]-dependent K(+) channel blocker) did not block the response to lubiprostone. However, glibenclamide (an ATP-sensitive K(+) channel blocker) blocked the response to lubiprostone. Similar to lubiprostone, pinacidil (an opener of ATP-sensitive K(+) channel) hyperpolarized the membrane and inhibited the generation of pacemaker potentials, and these effects were inhibited by glibenclamide. These results suggest that lubiprostone can modulate the pacemaker potentials of colonic ICCs via activation of ATP-sensitive K(+) channel through a prostanoid EP receptor-independent mechanism.

Effects of Lubiprostone on Pacemaker Activity of Interstitial Cells of Cajal from the Mouse Colon

PubMed Central

Jiao, Han-Yi; Kim, Dong Hyun; Ki, Jung Suk; Ryu, Kwon Ho; Choi, Seok

2014-01-01

Lubiprostone is a chloride (Cl-) channel activator derived from prostaglandin E1 and used for managing constipation. In addition, lubiprostone affects the activity of gastrointestinal smooth muscles. Interstitial cells of Cajal (ICCs) are pacemaker cells that generate slow-wave activity in smooth muscles. We studied the effects of lubiprostone on the pacemaker potentials of colonic ICCs. We used the whole-cell patch-clamp technique to determine the pacemaker activity in cultured colonic ICCs obtained from mice. Lubiprostone hyperpolarized the membrane and inhibited the generation of pacemaker potentials. Prostanoid EP1, EP2, EP3, and EP4 antagonists (SC-19220, PF-04418948, 6-methoxypyridine-2-boronc acid N-phenyldiethanolamine ester, and GW627368, respectively) did not block the response to lubiprostone. L-NG-nitroarginine methyl ester (L-NAME, an inhibitor of nitric oxide synthase) and 1H-[1,2,4]oxadiazolo[4,3,-a]quinoxalin-1-one (ODQ, an inhibitor of guanylate cyclase) did not block the response to lubiprostone. In addition, tetraethylammonium (TEA, a voltage-dependent potassium [K+] channel blocker) and apamin (a calcium [Ca2+]-dependent K+ channel blocker) did not block the response to lubiprostone. However, glibenclamide (an ATP-sensitive K+ channel blocker) blocked the response to lubiprostone. Similar to lubiprostone, pinacidil (an opener of ATP-sensitive K+ channel) hyperpolarized the membrane and inhibited the generation of pacemaker potentials, and these effects were inhibited by glibenclamide. These results suggest that lubiprostone can modulate the pacemaker potentials of colonic ICCs via activation of ATP-sensitive K+ channel through a prostanoid EP receptor-independent mechanism. PMID:25177167

Living with a pacemaker: patient-reported outcome of a pacemaker system.

PubMed

Magnusson, Peter; Liv, Per

2018-06-04

The aim of this study was to assess among pacemaker patients their overall satisfaction with the pacemaker system, pain, soreness/discomfort, cosmetic results, restrictions due to impaired movement of the shoulder/arm/chest, related sleep disturbances, and concern about possible device malfunction. The seven-item questionnaire was mailed to patients from a single center who had a pacemaker implant or replacement between 2006 and 2016. A higher score indicated worse outcome on a visual analog scale (VAS) of 0-100 mm. The response rate was 75.5% and 342 questionniares were analyzed. Median age of respondents was 77.6 years and 57.0% were males. In total, 65 complications requiring surgery (10 pocket corrections (2.9%), 5 in females) occurred during a median follow-up of 5.6 years.The distribution of the primary outcome had a median score of 5 while the 75th percentile was 13. Cosmetic appearance was significantly associated with reoperation (but not other variables). Overall scores for men and women were 5 vs. 6, respectively, which achieved significance (p = 0.042). Median ratings of pain, soreness/discomfort, cosmetic appearance, range of motion, sleep, and concern about device malfunction were all ≤5. Females reported worse outcomes for all questions, except for cosmetic results and concern about malfunction. The vast majority of patients report excellent overall satisfaction with the pacemaker system, and are not affected by pain, soreness/discomfort, or concern about device malfunction. They also reported favourable outcomes with respect to cosmetic results, shoulder movement, and sleep. However, some patients underwent a surgical correction of the pacemaker pocket.

Vascular access for hemodialysis: current perspectives

PubMed Central

Santoro, Domenico; Benedetto, Filippo; Mondello, Placido; Pipitò, Narayana; Barillà, David; Spinelli, Francesco; Ricciardi, Carlo Alberto; Cernaro, Valeria; Buemi, Michele

2014-01-01

A well-functioning vascular access (VA) is a mainstay to perform an efficient hemodialysis (HD) procedure. There are three main types of access: native arteriovenous fistula (AVF), arteriovenous graft, and central venous catheter (CVC). AVF, described by Brescia and Cimino, remains the first choice for chronic HD. It is the best access for longevity and has the lowest association with morbidity and mortality, and for this reason AVF use is strongly recommended by guidelines from different countries. Once autogenous options have been exhausted, prosthetic fistulae become the second option of maintenance HD access alternatives. CVCs have become an important adjunct in maintaining patients on HD. The preferable locations for insertion are the internal jugular and femoral veins. The subclavian vein is considered the third choice because of the high risk of thrombosis. Complications associated with CVC insertion range from 5% to 19%. Since an increasing number of patients have implanted pacemakers and defibrillators, usually inserted via the subclavian vein and superior vena cava into the right heart, a careful assessment of risk and benefits should be taken. Infection is responsible for the removal of about 30%–60% of HD CVCs, and hospitalization rates are higher among patients with CVCs than among AVF ones. Proper VA maintenance requires integration of different professionals to create a VA team. This team should include a nephrologist, radiologist, vascular surgeon, infectious disease consultant, and members of the dialysis staff. They should provide their experience in order to give the best options to uremic patients and the best care for their VA. PMID:25045278

Evaluation of Safety and Efficacy of Qinming8631 DR Implantable Cardiac Pacemaker in Chinese Patients: A Prospective, Multicenter, Randomized Controlled Trial of the First Domestically Developed Pacemaker of China.

PubMed

Xiang, Mei-Xiang; Wang, Dong-Qi; Xu, Jing; Zhang, Zheng; Hu, Jian-Xin; Wang, Dong-Mei; Gu, Xiang; Liu, He-Ping; Guo, Tao; Yang, Xiang-Jun; Ling, Feng; Lin, Jia-Feng; Cai, Shang-Lang; Zhu, Guo-Bin; Wang, Jian-An

2016-11-20

High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia, and a domestically developed pacemaker will help lower the burden. This study aimed to evaluate the safety and efficacy of Qinming8631 DR (Qinming Medical, Baoji, China), the first domestically developed dual-chamber pacemaker of China, compared with a commercially available pacemaker Talos DR (Biotronik, Berlin, Germany) in Chinese patients. A prospective randomized trial was conducted at 14 centers in China. Participants were randomized into trial (Qinming8631 DR) and control (Talos DR) groups. Parameters of the pacing systems were collected immediately after device implantation and during follow-ups. The effective pacing rate at 6-month follow-up was recorded as the primary end point. Electrical properties, magnet response, single- and double-pole polarity conversion, rate response function, and adverse events of the pacing system were analyzed. The Cochran-Mantel-Haenszel Chi-square test, paired t-test, and Wilcoxon signed-rank test were used for measuring primary qualitative outcomes and comparing normally and abnormally distributed measurement data. A total of 225 patients with a diagnosis of bradyarrhythmia and eligible for this study were randomly enrolled into the trial (n = 113) and control (n = 112) groups. They underwent successful pacemaker implantation with acceptable postoperative pacing threshold and sensitivity. Effective pacing rates of trial and control groups were comparable both in the full analysis set and the per protocol set (81.4% vs. 79.5%, P = 0.712 and 95.4% vs. 89.5%, P = 0.143, respectively). In both data sets, noninferiority of the trial group was above the predefined noninferiority limit(-9.5%). This study established the noninferiority of Qinming8631 DR to Talos DR. The safety and efficacy of Qinming8631 DR pacemaker were comparable to those of Talos DR in treating patients with cardiac bradyarrhythmia.

Long-term screening for sleep apnoea in paced patients: preliminary assessment of a novel patient management flowchart by using automatic pacemaker indexes and sleep lab polygraphy.

PubMed

Aimé, Ezio; Rovida, Marina; Contardi, Danilo; Ricci, Cristian; Gaeta, Maddalena; Innocenti, Ester; Cabral Tantchou-Tchoumi, Jacques

2014-10-01

The primary aim of this pilot study was to prospectively assess a flowchart to screen and diagnose paced patients (pts) affected by sleep apnoeas, by crosschecking indexes derived from pacemakers (minute ventilation sensor on-board) with Sleep-Lab Polygraphy (PG) outcomes. Secondarily, "smoothed" long-term pacemaker indexes (all the information between two consecutive follow-up visits) have been retrospectively compared vs. standard short-term pacemaker indexes (last 24h) at each follow-up (FU) visit, to test their correlation and diagnostic concordance. Data from long-term FU of 61 paced pts were collected. At each visit, the standard short-term apnoea+hypopnoea (PM_AHI) index was retrieved from the pacemaker memory. Patients showing PM_AHI ≥ 30 at least once during FU were proposed to undergo a PG for diagnostic confirmation. Smoothed pacemaker (PM_SAHI) indexes were calculated by averaging the overall number of apnoeas/hypopnoeas over the period between two FU visits, and retrospectively compared with standard PM_AHI. Data were available from 609 consecutive visits (overall 4.64 ± 1.78 years FU). PM_AHI indexes were positive during FU in 40/61 pts (65.6%); 26/40 pts (65%) accepted to undergo a PG recording; Sleep-Lab confirmed positivity in 22/26 pts (84.6% positive predictive value for PM_AHI). A strong correlation (r=0.73) and a high level of concordance were found between smoothed and standard indexes (multivariate analysis, Cohen's-k and Z-score tests). Pacemaker-derived indexes may help in screening paced pts potentially affected by sleep apnoeas. Long-term "smoothed" apnoea indexes could improve the accuracy of pacemaker screening capability, even though this hypothesis must be prospectively confirmed by larger studies. Copyright © 2014 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

Exploring the mechanism of action of the sperm-triggered calcium-wave pacemaker in ascidian zygotes.

PubMed

Carroll, Michael; Levasseur, Mark; Wood, Chris; Whitaker, Michael; Jones, Keith T; McDougall, Alex

2003-12-15

In ascidians, as in mammals, sperm trigger repetitive Ca2+-waves that originate from cortical pacemakers situated in the vegetal hemisphere of the zygotes. In ascidians, a vegetal protrusion termed the contraction pole (CP) acts as the Ca2+-wave pacemaker, but the mechanism that underlies the generation of a Ca2+-wave pacemaker is not known. Here, we tested four hypotheses to determine which factors at the CP are involved in setting the pace of the ascidian Ca2+-wave pacemaker: (1) localized Ca2+ influx; (2) accumulation of phosphatidylinositol (4,5)bisphosphate [PtdIns(4,5)P2]; (3) accumulation of cortical endoplasmic reticulum (cER); and (4) enrichment of the sperm activating factor. We developed a method of dynamically monitoring the location of the CP during fertilization using a plekstrin homology (PH) domain from phospholipase Cdelta1 coupled to green fluorescent protein (GFP) that binds PtdIns(4,5)P2. We found that eggs in Ca2+-free sea water displayed Ca2+ waves that originated from the CP, showing that enhanced CP Ca2+ influx does not determine the origin of the pacemaker. Also, disruption of the PH::GFP-labelled CP once it had formed did not dislodge the Ca2+-wave pacemaker from that site. Next, when we prevented the accumulation of cER at the CP, all of the Ca2+ waves came from the site of sperm-egg fusion and the frequency of Ca2+ oscillations was unaltered. These data show that local Ca2+ influx, the accumulation of PtdIns(4,5)P2 and cER at the CP are not required for Ca2+-wave pacemaker function and instead suggest that a factor associated with the sperm determines the site of the Ca2+-wave pacemaker. Finally, when we injected ascidian sperm extract into the centre of unfertilized ascidian eggs that had been treated with microfilament- and microtubule-disrupting drugs, all the Ca2+ waves still originated from near the plasma membrane, showing that the sperm factor does not require an intact cortex if it is enriched near the plasma membrane (PM). We suggest that the Ca2+-releasing sperm factor might be tethered near or on the PM and that following the cortical contraction, it is translocated to the vegetal CP, thus making that site act as a Ca2+-wave pacemaker.

Bradycardia in perspective-not all reductions in heart rate need immediate intervention.

PubMed

Mason, Keira P; Lönnqvist, Per-Arne

2015-01-01

According to Wikipedia, the word 'bradycardia' stems from the Greek βραδύς, bradys, 'slow', and καρδία, kardia, 'heart'. Thus, the meaning of bradycardia is slow heart rate but not necessarily too slow heart rate. If looking at top endurance athletes they may have a resting heart rate in the very low thirties without needing emergent intervention with anticholinergics, isoprenaline, epinephrine, chest compressions or the insertion of an emergency pacemaker (Figure 1). In fact, they withstand these episodes without incident, accommodating with a compensatory increase in stroke volume to preserve and maintain cardiac output. With this in mind, it is difficult for the authors to fully understand and agree with the general sentiment amongst many pediatric anesthesiologists that all isolated bradycardia portends impending doom and must be immediately treated with resuscitative measures. © 2014 John Wiley & Sons Ltd.

Proposed diagnostic reference levels for 3 common cardiac interventional procedures in Ireland

NASA Astrophysics Data System (ADS)

D'Helft, C.; McGee, A. M.; Rainford, L. A.; Mc Fadden, S. L.; Hughes, C. M.; Winder, R. J.; Brennan, P. C.

2007-03-01

Radiation doses for 3 common types of cardiac radiological examinations where investigated: coronary angiography (CA), percutaneous coronary intervention (PCI) and pacemaker insertions (PPI). 22 cardiac imaging suites participated in the study. Radiation dose was monitored for 1804 adult patients using dose area product (DAP) meters. Operational and examination details such as cardiologist grade, patient details and examination complexity were recorded for each examination. Both intra and inter-hospital variations where demonstrated by the results. Individual patient DAP values ranged from 136-23,101cGycm2, 475-41,038cGycm2 and 45- 17,192cGycm2 for CA, PCI and PPI respectively, with third quartile values of 4,173cGycm2, 8,836cGycm2 and 2,051cGycm2. Screening times varied from 0.22-27.6mins, 1.8-98mins and 0.33-54.5mins for CA, PCI and PPI respectively.

Gender-Related and Age-Related Differences in Implantable Defibrillator Recipients: Results From the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS").

PubMed

Feldman, Alyssa M; Kersten, Daniel J; Chung, Jessica A; Asheld, Wilbur J; Germano, Joseph; Islam, Shahidul; Cohen, Todd J

2015-12-01

The purpose of this study was to investigate the influences of gender and age on defibrillator lead failure and patient mortality. The specific influences of gender and age on defibrillator lead failure have not previously been investigated. This study analyzed the differences in gender and age in relation to defibrillator lead failure and mortality of patients in the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS"). PAIDLESS includes all patients at Winthrop University Hospital who underwent defibrillator lead implantation between February 1, 1996 and December 31, 2011. Male and female patients were compared within each age decile, beginning at 15 years old, to analyze lead failure and patient mortality. Statistical analyses were performed using Wilcoxon rank-sum test, Fisher's exact test, Kaplan-Meier analysis, and multivariable Cox regression models. P<.05 was considered statistically significant. No correction for multiple comparisons was performed for the subgroup analyses. A total of 3802 patients (2812 men and 990 women) were included in the analysis. The mean age was 70 ± 13 years (range, 15-94 years). Kaplan-Meier analysis found that between 45 and 54 years of age, leads implanted in women failed significantly faster than in men (P=.03). Multivariable Cox regression models were built to validate this finding, and they confirmed that male gender was an independent protective factor of lead failure in the 45 to 54 years group (for male gender: HR, 0.37; 95% confidence interval, 0.14-0.96; P=.04). Lead survival time for women in this age group was 13.4 years (standard error, 0.6), while leads implanted in men of this age group survived 14.7 years (standard error, 0.3). Although there were significant differences in lead failure, no differences in mortality between the genders were found for any ages or within each decile. This study is the first to compare defibrillator lead failure and patient mortality in relation to gender and age deciles at a single large implanting center. Within the 45 to 54 years group, leads implanted in women failed faster than in men. Male gender was found to be an independent protective factor in lead survival. This study emphasizes the complex interplay between gender and age with respect to implantable defibrillator lead failure and mortality.

Heart pacemaker - discharge

MedlinePlus

... table saws) Electric lawnmowers and leaf blowers Slot machines Stereo speakers Tell all providers that you have a pacemaker before any tests are done. Some medical equipment may interfere with ...

Tricuspid Regurgitation and Mortality in Patients with Transvenous Permanent Pacemaker Leads

PubMed Central

Delling, Francesca N.; Hassan, Zena K.; Piatkowski, Gail; Tsao, Connie W.; Rajabali, Alefiyah; Markson, Lawrence J.; Zimetbaum, Peter J.; Manning, Warren J.; Chang, James D.; Mukamal, Kenneth J.

2016-01-01

Estimates of the prevalence and importance of significant tricuspid regurgitation (STR) related to implantable device leads are based mainly on case reports, small observational studies or mixed samples that include defibrillators. We sought to assess whether patients with permanent pacemaker (PPM) leads have an increased risk of STR and to determine mortality associated with PPM-related TR in a large longitudinal single-center cohort. We examined the prevalence of STR (defined as moderate-severe or ≥ 3+) among all echocardiograms performed between 2005 and 2011 excluding those with defibrillators. We then examined mortality risk according to the prevalence of PPM and STR after adjusting for cardiac co-morbidities, left ventricular (LV) systolic/diastolic function, and pulmonary artery hypertension. We screened 93592 echocardiograms (1245 with PPM) among 58556 individual patients (634 with PPM). The prevalence of STR was higher in patients following PPM placement (mean age 79 ± 3 years; 54% males) compared to patients without a PPM (adjusted odds ratio 2.32, 95% confidence interval [CI], 1.54–3.49; p<0.0001). Among patients with a PPM lead, the presence of STR was associated with increased mortality (adjusted hazard ratios [HR] 1.40, 95% CI 1.04–2.11, p=0.027 versus no STR). Compared to having neither a PPM lead nor STR, adjusted HR for death were 2.13 (95% CI, 1.93–2.34) for STR but no PPM, 1.04 (0.89–1.22) for PPM without STR, and 1.55 (1.13–2.14) for PPM with STR. In conclusion, in a sample comprising over 58,000 individual patients, PPM leads are associated with higher risk of STR after adjustment for LV systolic/diastolic function and pulmonary artery hypertension; similarly to STR from other cardiac pathologies, PPM-related STR is associated with increased mortality. PMID:26833208

A Screening of UNF Targets Identifies Rnb, a Novel Regulator of Drosophila Circadian Rhythms.

PubMed

Kozlov, Anatoly; Jaumouillé, Edouard; Machado Almeida, Pedro; Koch, Rafael; Rodriguez, Joseph; Abruzzi, Katharine C; Nagoshi, Emi

2017-07-12

Behavioral circadian rhythms are controlled by multioscillator networks comprising functionally different subgroups of clock neurons. Studies have demonstrated that molecular clocks in the fruit fly Drosophila melanogaster are regulated differently in clock neuron subclasses to support their specific functions (Lee et al., 2016; Top et al., 2016). The nuclear receptor unfulfilled ( unf ) represents a regulatory node that provides the small ventral lateral neurons (s-LNvs) unique characteristics as the master pacemaker (Beuchle et al., 2012). We previously showed that UNF interacts with the s-LNv molecular clocks by regulating transcription of the core clock gene period ( per ) (Jaumouillé et al., 2015). To gain more insight into the mechanisms by which UNF contributes to the functioning of the circadian master pacemaker, we identified UNF target genes using chromatin immunoprecipitation. Our data demonstrate that a previously uncharacterized gene CG7837 , which we termed R and B ( Rnb ), acts downstream of UNF to regulate the function of the s-LNvs as the master circadian pacemaker. Mutations and LNv-targeted adult-restricted knockdown of Rnb impair locomotor rhythms. RNB localizes to the nucleus, and its loss-of-function blunts the molecular rhythms and output rhythms of the s-LNvs, particularly the circadian rhythms in PDF accumulation and axonal arbor remodeling. These results establish a second pathway by which UNF interacts with the molecular clocks in the s-LNvs and highlight the mechanistic differences in the molecular clockwork within the pacemaker circuit. SIGNIFICANCE STATEMENT Circadian behavior is generated by a pacemaker circuit comprising diverse classes of pacemaker neurons, each of which contains a molecular clock. In addition to the anatomical and functional diversity, recent studies have shown the mechanistic differences in the molecular clockwork among the pacemaker neurons in Drosophila Here, we identified the molecular characteristics distinguishing the s-LNvs, the master pacemaker of the locomotor rhythms, from other clock neuron subtypes. We demonstrated that a newly identified gene Rnb is an s-LNv-specific regulator of the molecular clock and essential for the generation of circadian locomotor behavior. Our results provide additional evidence to the emerging view that the differential regulation of the molecular clocks underlies the functional differences among the pacemaker neuron subgroups. Copyright © 2017 the authors 0270-6474/17/376673-13$15.00/0.

Computational analysis of the human sinus node action potential: model development and effects of mutations

PubMed Central

Fabbri, Alan; Fantini, Matteo; Wilders, Ronald

2017-01-01

Key points We constructed a comprehensive mathematical model of the spontaneous electrical activity of a human sinoatrial node (SAN) pacemaker cell, starting from the recent Severi–DiFrancesco model of rabbit SAN cells.Our model is based on electrophysiological data from isolated human SAN pacemaker cells and closely matches the action potentials and calcium transient that were recorded experimentally.Simulated ion channelopathies explain the clinically observed changes in heart rate in corresponding mutation carriers, providing an independent qualitative validation of the model.The model shows that the modulatory role of the ‘funny current’ (I f) in the pacing rate of human SAN pacemaker cells is highly similar to that of rabbit SAN cells, despite its considerably lower amplitude.The model may prove useful in the design of experiments and the development of heart‐rate modulating drugs. Abstract The sinoatrial node (SAN) is the normal pacemaker of the mammalian heart.  Over several decades, a large amount of data on the ionic mechanisms underlying the spontaneous electrical activity of SAN pacemaker cells has been obtained, mostly in experiments on single cells isolated from rabbit SAN. This wealth of data has allowed the development of mathematical models of the electrical activity of rabbit SAN pacemaker cells. The present study aimed to construct a comprehensive model of the electrical activity of a human SAN pacemaker cell using recently obtained electrophysiological data from human SAN pacemaker cells.  We based our model on the recent Severi–DiFrancesco model of a rabbit SAN pacemaker cell. The action potential and calcium transient of the resulting model are close to the experimentally recorded values. The model has a much smaller ‘funny current’ (I f) than do rabbit cells, although its modulatory role is highly similar. Changes in pacing rate upon the implementation of mutations associated with sinus node dysfunction agree with the clinical observations. This agreement holds for both loss‐of‐function and gain‐of‐function mutations in the HCN4, SCN5A and KCNQ1 genes, underlying ion channelopathies in I f, fast sodium current and slow delayed rectifier potassium current, respectively. We conclude that our human SAN cell model can be a useful tool in the design of experiments and the development of drugs that aim to modulate heart rate. PMID:28185290

Clinical and electrophysiological characteristics of patients with paroxysmal intra-His block with narrow QRS complexes.

PubMed

Ragupathi, Loheetha; Johnson, Drew; Greenspon, Arnold; Frisch, Daniel; Ho, Reginald T; Pavri, Behzad B

2018-04-18

Atrioventricular (AV) block is usually due to infranodal disease and associated with a wide QRS complex; such patients often progress to complete AV block and pacemaker dependency. Uncommonly, infranodal AV block can occur within the His bundle with a narrow QRS complex. The aims of this study were to define clinical/echocardiographic characteristics of patients with AV block within the His bundle and report progression to pacemaker dependency. We retrospectively identified patients with narrow QRS complexes and documented intra-His delay or block at electrophysiology study (group A) or with electrocardiogram-documented Mobitz II AV block/paroxysmal AV block (group B). Clinical, electrophysiological, and echocardiographic variables at presentation and pacemaker parameters at the last follow-up visit were evaluated. Twenty-seven patients (19 women) were identified (mean age 64 ± 13 years; range, 38-85 years). Four patients who had <1 month of follow-up were excluded. There were 12 patients in group A and 11 in group B; 21 of 23 presented with syncope/presyncope. All patients received pacemakers: 8 single chamber and 15 dual chamber. After a median follow-up of 6.4 years, the median percentage of ventricular pacing was 1% (interquartile range 0%-4.66%). One patient developed true pacemaker dependency. Aortic and/or mitral annular calcification was present in 13 of 22 patients with available echocardiograms. Patients who present with syncope and narrow QRS complexes with intra-His delay or Mobitz II paroxysmal AV block with narrow QRS complexes rarely progress to pacemaker dependency and require infrequent pacing. This entity is more common in women, with a higher prevalence of aortic and/or mitral annular calcification. If confirmed by additional studies, single-chamber pacemaker may be sufficient. Copyright © 2018 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Zero-fluoroscopy permanent pacemaker implantation using Ensite NavX system: Clinical viability or fanciful technique?

PubMed

Guo, Ping; Qiu, Jie; Wang, Yan; Chen, Guangzhi; Proietti, Riccardo; Fadhle, Al-Selmi; Zhao, Chunxia; Wen Wang, Dao

2018-02-01

Fluoroscopy is the imaging modality routinely used for cardiac device implantation and electrophysiological procedures. Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs, novel 3D mapping systems have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers. Their applicability in cardiac device implantation has been rarely reported. Our aim is to evaluate the feasibility and safety of permanent pacemaker implantation without fluoroscopy. From January 2012 to June 2016, six patients (50 ± 15 years, four of six were female, one of who was at the 25th week of gestation) who underwent permanent pacemaker implantation were included (zero-fluoroscopy group). Data from 20 consecutive cases of implantation performed under fluoroscopy guidance were chosen as a control group (fluoroscopy group). Total implantation procedure time for single-chamber pacemaker was 51.3 ± 13.1 minutes in the zero-fluoroscopy group and 42.6 ± 7.4 minutes in the fluoroscopy group (P  =  0.155). The implantation procedural time for a dual-chamber pacemaker was 88.3 ± 19.6 minutes and 67.3 ± 7.6 minutes in the zero-fluoroscopy and fluoroscopy groups (P  =  0.013), respectively. No complications were observed during the procedure and the follow-up in the two groups, and all pacemakers worked with satisfactory parameters. Ensite NavX system can be used as a reliable and safe zero-fluoroscopy approach for the implantation of single- or dual-chamber permanent pacemakers in specific patients, such as pregnant women or in extreme situations when the x-ray machine is not available. © 2017 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals, Inc.

Management and outcome of patients with acute myocardial infarction presenting with pacemaker rhythm.

PubMed

Bertel, Noemi; Witassek, Fabienne; Puhan, Milo; Erne, Paul; Rickli, Hans; Naegeli, Barbara; Pedrazzini, Giovanni; Stauffer, Jean-Christophe; Radovanovic, Dragana

2017-03-01

Diagnosis of acute myocardial infarction (MI) is challenging in pacemaker patients. Little is known about this patient group. Patients with MI enrolled in the Swiss national AMIS Plus registry between January 2005 and December 2015 were analyzed. All patients with either paced ventricular rhythm or sinus rhythm with intrinsic ventricular conduction (IVC) were included in this study. Outcomes using crude data and propensity score matching were compared between patients with pacemaker rhythm and patients with IVC. The primary endpoint was in-hospital death. Data from 300 patients with paced rhythm and 27,595 with IVC were analyzed. Patients with pacemaker rhythm were older (78.2y vs 65.4y; p<0.001), had more comorbidities (Charlson Index (CCI)>1: 54.0% vs 21.1%; p<0.001) and a higher rate of heart failure upon presentation (Killip class>2, 11.0% vs 5.9%; p<0.001) compared to patients with IVC. Door to balloon time in patients undergoing acute PCI is markedly delayed in contrast to patients with IVC (280min vs 85min; p<0.001). Consequently, crude mortality in patients with pacemakers was high (11.3% vs 4.6%; p<0.001). However, when analyzed with propensity matching for gender, age, CCI>1 and Killip>2, mortality was similar (11.2% vs 10.5%; p=0.70). Pacemaker patients with acute MI represent a high-risk group with doubled crude mortality compared to patients without pacemakers, due to higher age and higher Killip class. Diagnosis is difficult and results in delayed treatment. Treatment algorithms for MI with paced rhythm should possibly be adapted to those used for STEMI or new left bundle branch block. NCT01305785. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Regulation of basal and reserve cardiac pacemaker function by interactions of cAMP mediated PKA-dependent Ca2+ cycling with surface membrane channels

PubMed Central

Vinogradova, Tatiana M.; Lakatta, Edward G.

2009-01-01

Decades of intensive research of primary cardiac pacemaker, the sinoatrial node, have established potential roles of specific membrane channels in the generation of the diastolic depolarization, the major mechanism allowing sinoatrial node cells generate spontaneous beating. During the last three decades, multiple studies made either in the isolated sinoatrial node or sinoatrial node cells have demonstrated a pivotal role of Ca2+ and, specifically Ca2+-release from sarcoplasmic reticulum, for spontaneous beating of cardiac pacemaker. Recently, spontaneous, rhythmic local subsarcolemmal Ca2+ releases from ryanodine receptors during late half of the diastolic depolarization have been implicated as a vital factor in the generation of sinoatrial node cells spontaneous firing. Local Ca2+ releases are driven by a unique combination of high basal cAMP production by adenylyl cyclases, high basal cAMP degradation by phosphodiesterases and a high level of cAMP-mediated PKA-dependent phosphorylation. These local Ca2+ releases activate an inward Na+-Ca2+ exchange current which accelerates the terminal diastolic depolarization rate and, thus, controls the spontaneous pacemaker firing. Both the basal primary pacemaker beating rate and its modulation via β-adrenergic receptor stimulation appear to be critically dependent upon intact RyR function and local subsarcolemmal sarcoplasmic reticulum generated Ca2+ releases. This review aspires to integrate the traditional viewpoint that has emphasized the supremacy of the ensemble of surface membrane ion channels in spontaneous firing of the primary cardiac pacemaker, and these novel perspectives of cAMP-mediated PKA-dependent Ca2+ cycling in regulation of the heart pacemaker clock, both in the basal state and during β-adrenergic receptor stimulation. PMID:19573534

Low permanent pacemaker rates following Lotus device implantation for transcatheter aortic valve replacement due to modified implantation protocol.

PubMed

Krackhardt, Florian; Kherad, Behrouz; Krisper, Maximilian; Pieske, Burkert; Laule, Michael; Tschöpe, Carsten

2017-01-01

Conduction disturbances requiring permanent pacemaker implantation following transcatheter aortic valve replacement (TAVR) are a common problem. Pacemaker implantation rates after TAVR appear to be higher compared to conventional aortic valve replacement. The aim of this study was to analyze whether a high annulus implantation conveys the benefit of a decreased rate of permanent pacemaker implantation while being safe and successful according to Valve Academic Research Consortium 2 (VARC2)-criteria. A total of 23 patients with symptomatic severe aortic valve stenosis, an aortic annulus of 19-27 mm and at high risk for surgery were treated with the Lotus valve. In all patients the valve was implanted in a high annulus position via femoral access. The primary device performance endpoint was VARC2-defined device success after 30 days and the primary safety endpoint was the need for permanent pacemaker implantation. The mean age was 73.23 ± 7.65 years, 46% were female, 38% were New York Heart Association class III/IV at baseline. Thirty-day follow-up data were available for all patients. The VARC2-defined device success rate after 30 days was 22/23 (96%). 2/21 (10%) patients required a newly implanted pacemaker due to 3rd degree atrioventricular block. 25% of the patients developed a new left bundle branch block after valvuloplasty or device implantation. 21 of the 23 patients (96%) had no other signs of conduction disturbances after 30 days. The approach of the modified implantation technique of Lotus TAVR device was safe and effective. The incidence of need for a permanent pacemaker following TAVR could be significantly reduced due to adopted implantation protocol.

Autaptic pacemaker mediated propagation of weak rhythmic activity across small-world neuronal networks

NASA Astrophysics Data System (ADS)

Yilmaz, Ergin; Baysal, Veli; Ozer, Mahmut; Perc, Matjaž

2016-02-01

We study the effects of an autapse, which is mathematically described as a self-feedback loop, on the propagation of weak, localized pacemaker activity across a Newman-Watts small-world network consisting of stochastic Hodgkin-Huxley neurons. We consider that only the pacemaker neuron, which is stimulated by a subthreshold periodic signal, has an electrical autapse that is characterized by a coupling strength and a delay time. We focus on the impact of the coupling strength, the network structure, the properties of the weak periodic stimulus, and the properties of the autapse on the transmission of localized pacemaker activity. Obtained results indicate the existence of optimal channel noise intensity for the propagation of the localized rhythm. Under optimal conditions, the autapse can significantly improve the propagation of pacemaker activity, but only for a specific range of the autaptic coupling strength. Moreover, the autaptic delay time has to be equal to the intrinsic oscillation period of the Hodgkin-Huxley neuron or its integer multiples. We analyze the inter-spike interval histogram and show that the autapse enhances or suppresses the propagation of the localized rhythm by increasing or decreasing the phase locking between the spiking of the pacemaker neuron and the weak periodic signal. In particular, when the autaptic delay time is equal to the intrinsic period of oscillations an optimal phase locking takes place, resulting in a dominant time scale of the spiking activity. We also investigate the effects of the network structure and the coupling strength on the propagation of pacemaker activity. We find that there exist an optimal coupling strength and an optimal network structure that together warrant an optimal propagation of the localized rhythm.

Percutaneous Resection of Renal Urothelial Carcinoma Using Bipolar Electrocautery

PubMed Central

Kwan, Kevin G.; Chew, Ben H.; Luke, Patrick P.W.; Denstedt, John D.

2006-01-01

Percutaneous approaches to upper tract urothelial cancers have been performed in patients unsuitable for radical nephroureterectomy. We present the case of an 82-year-old man with significant comorbidities including dependency on a cardiac pacemaker. Without deactivating the pacemaker, we used bipolar cautery to percutaneously resect a large upper tract urothelial tumor in the renal pelvis. Bipolar cautery is a suitable method of percutaneous or transurethral resection in patients who are pacemaker dependent. PMID:17575777

Development of the cardiac pacemaker

PubMed Central

Liang, Xingqun; Evans, Sylvia M.

2017-01-01

The sinoatrial node (SAN) is the dominant pacemaker of the heart. Abnormalities in SAN formation and function can cause sinus arrhythmia, including sick sinus syndrome and sudden death. A better understanding of genes and signaling pathways that regulate SAN development and function is essential to develop more effective treatment to sinus arrhythmia, including biological pacemakers. In this review, we briefly summarize the key processes of SAN morphogenesis during development, and focus on the transcriptional network that drives SAN development. PMID:27770149

Circadian locomotor rhythms in the cricket, Gryllodes sigillatus. II. Interactions between bilaterally paired circadian pacemakers.

PubMed

Ushirogawa, H; Abe, Y; Tomioka, K

1997-10-01

The optic lobe is essential for circadian locomotor rhythms in the cricket, Gryllodes sigillatus. We examined potential interactions between the bilaterally paired optic lobes in circadian rhythm generation. When one optic lobe was removed, the free-running period of the locomotor rhythm slightly but significantly lengthened. When exposed to light-dark cycles (LD) with 26 hr period, intact and sham operated animals were clearly entrained to the light cycle, but a large number of animals receiving unilateral optic nerve severance showed rhythm dissociation. In the dissociation, two rhythmic components appeared; one was readily entrained to the given LD and the other free-ran with a period shorter than 24 hr, and activity was expressed only when they were inphase. The period of the free-running component was significantly longer than that of the animals with a single blinded pacemaker kept in LD13:13, suggesting that the pacemaker on the intact side had some influence on the blinded pacemaker even in the dissociated state. The ratio of animals with rhythm dissociation was greater with the lower light intensity of the LD. The results suggest that the bilaterally distributed pacemakers are only weakly coupled to one another but strongly suppress the activity driven by the partner pacemaker during their subjective day. The strong suppression of activity would be advantageous to keep a stable nocturnality for this cricket living indoors.

The effect of hyperkalaemia on cardiac rhythm devices.

PubMed

Barold, S Serge; Herweg, Bengt

2014-04-01

In patients with pacemakers, hyperkalaemia causes three important abnormalities that usually become manifest when the K level exceeds 7 mEq/L: (i) widening of the paced QRS complex from delayed intraventricular conduction velocity, (ii) Increased atrial and ventricular pacing thresholds that may cause failure to capture. In this respect, the atria are more susceptible to loss of capture than the ventricles, and (iii) Increased latency (usually with ventricular pacing) manifested by a greater delay of the interval from the pacemaker stimulus to the onset of depolarization. First-degree ventricular pacemaker exit block may progress to second-degree Wenckebach (type I) exit block characterized by gradual prolongation of the interval from the pacemaker stimulus to the onset of the paced QRS complex ultimately resulting in an ineffectual stimulus. The disturbance may then progress to 2 : 1, 3 : 1 pacemaker exit block, etc., and eventually to complete exit block with total lack of capture. Ventricular undersensing is uncommonly observed because of frequent antibradycardia pacing. During managed ventricular pacing, hyperkalaemia-induced marked first-degree atrioventricular block may induce a pacemaker syndrome. With implantable cardioverter-defibrillators (ICDs) oversensing of the paced or spontaneous T-wave may occur. The latter may cause inappropriate shocks. A raised impedance from the right ventricular coil to the superior vena cava coil may become an important sign of hyperkalaemia in the asymptomatic or the minimally symptomatic ICD patient.

Modeling and experimental verification of a fan-folded vibration energy harvester for leadless pacemakers

NASA Astrophysics Data System (ADS)

Ansari, M. H.; Karami, M. Amin

2016-03-01

This paper studies energy harvesting from heartbeat vibrations for powering leadless pacemakers. Unlike traditional pacemakers, leadless pacemakers are implanted inside the heart and the pacemaker is in direct contact with the myocardium. A leadless pacemaker is in the shape of a cylinder. Thus, in order to utilize the available 3-dimensional space for the energy harvester, we choose a fan-folded 3D energy harvester. The proposed device consists of several piezoelectric beams stacked on top of each other. The volume of the energy harvester is 1 cm3 and its dimensions are 2 cm × 0.5 cm × 1 cm. Although high natural frequency is generally a major concern with micro-scale energy harvesters, by utilizing the fan-folded geometry and adding tip mass and link mass to the configuration, we reduced the natural frequency to the desired range. This fan-folded design makes it possible to generate more than 10 μ W of power per cubic centimeter. The proposed device is compatible with Magnetic Resonance Imaging. Although the proposed device is a linear energy harvester, it is relatively insensitive to the heart rate. The natural frequencies and the mode shapes of the device are calculated analytically. The accuracy of the analytical model is verified by experimental investigations. We use a closed loop shaker system to precisely replicate heartbeat vibrations in vitro.

Comparison of DDD versus VVIR pacing modes in elderly patients with atrioventricular block.

PubMed

Kılıçaslan, Barış; Vatansever Ağca, Fahriye; Kılıçaslan, Esin Evren; Kınay, Ozan; Tigen, Kürşat; Cakır, Cayan; Nazlı, Cem; Ergene, Oktay

2012-06-01

Dual-chamber pacing is believed to have an advantage over single-chamber ventricular pacing. The aim of this study was to determine whether elderly patients who have implanted pacemakers for complete atrioventricular block gain significant benefits from dual-chamber (DDD) pacemakers compared with single chamber ventricular (VVIR) pacemakers. This study was designed as a randomized, two-period crossover study-each pacing mode was maintained for 1 month. Thirty patients (16 men, mean age 68.87 ± 6.89 years) with implanted DDD pacemakers were submitted to a standard protocol, which included an interview, pacemaker syndrome assessment, health related quality of life (HRQoL) questionnaires assessed by an SF-36 test, 6-minute walk test (6MWT), and transthoracic echocardiographic examinations. All of these parameters were obtained on both DDD and VVIR mode pacing. Paired data were compared. HRQoL scores were similar, and 6MWT results did not differ between the two groups. VVIR pacing elicited significant enlargement of the left atrium and impaired left ventricular diastolic functions as compared with DDD pacing. Two patients reported subclinical pacemaker syndrome, but this was not statistically significant. Our study revealed that in active elderly patients with complete heart block, DDD pacing and VVIR pacing yielded similar improvements in QoL and exercise performance. However, after a short follow-up period, we noted that VVIR pacing caused significant left atrial enlargement and impaired left ventricular diastolic functions.

Tricuspid Valve Dysfunction Following Pacemaker or Cardioverter-Defibrillator Implantation.

PubMed

Chang, James D; Manning, Warren J; Ebrille, Elisa; Zimetbaum, Peter J

2017-05-09

The potential for cardiac implantable electronic device leads to interfere with tricuspid valve (TV) function has gained increasing recognition as having hemodynamic and clinical consequences associated with incremental morbidity and death. The diagnosis and treatment of lead-related (as distinct from functional) tricuspid regurgitation pose unique challenges. Because of pitfalls in routine diagnostic imaging, a high level of clinical suspicion must be maintained to avoid overlooking the possibility that worsening heart failure is a consequence of mechanical interference with TV leaflet mobility or coaptation and is amenable to lead extraction or valve repair or replacement. The future of cardiac implantable electronic devices includes pacing and perhaps defibrillation without a lead traversing the TV. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Efficiency of lithium pacemaker batteries as a function of discharge rate and iodine:P2VP cathode composition

DOE Office of Scientific and Technical Information (OSTI.GOV)

Helgeson, W.D.; Fester, K.E.

1980-01-01

Electrochemical discharge data for Li/I/sub 2/-P2VP pacemaker batteries at various discharge currents show the efficiency of the battery to be a function of discharge current. Depending on the iodine:P2VP cathode composition, the optimum current drain occurs between discharge currents of 100 to 200 /mu/a. As current drain is reduced to pacemaker application drains, 15-25 /mu/a, the efficiency of the Li/I/sub 2/-P2VP battery decreases. The loss in efficiency at pacemaker rates is attributed primarily to self-discharge. The efficiency of Li/I/sub 2/-P2VP batteries is improved by increasing the percent of iodine in the cathode. I/sub 2/:P2VP weight ratios of 10:1, 15:1 andmore » 20:1 have been discharged at various currents and the data indicate that there is significant improvement in efficiency at pacemaker rate in going from 10:1 to 20:1 cathode weight ratio. 2 refs.« less

Battery Malfunction of a Leadless Cardiac Pacemaker - A Worrisome Single-Center Experience.

PubMed

Richter, Sergio; Döring, Michael; Ebert, Micaela; Bode, Kerstin; Müssigbrodt, Andreas; Sommer, Philipp; Husser, Daniela; Hindricks, Gerhard

2018-03-14

Leadless cardiac pacemaker (LCP) therapy has been established clinically as a feasible and safe alternative to conventional transvenous pacemaker therapy for patients with an indication for single-chamber right-ventricular pacing. 1-3 However, reports on loss of telemetry and pacing output due to abrupt battery failure called the safety of one of the two commercially available systems seriously into question. The initial battery advisory with the Nanostim™ LCP was issued by the manufacturer in October 2016, who instantly called a global stop to Nanostim™ implants. To this day, similar battery issues have not been described for the Micra™ transcatheter pacing system. Therefore, we thought to analyze the long-term pacemaker performance and rate of battery malfunction of the Nanostim™ LCP in our patient population.

Ductal carcinoma of the breast in the pacemaker generator's pocket.

PubMed

Zonca, P; Herokova, J; Cambal, M; Jacobi, C A

2009-01-01

Authors present a case of a 78-year-old female patient with invasive ductal adenocarcinoma in the pacemaker, s pocket. A decubitus-like tumor had developed in this place, and has been missinterpretated as a benign lesion for 5 months. Diagnosis was done with a time delay. An excisional biopsy revealed annvasive ductal adenocarcinoma. The first step was the implantation of a new pacemaker generator performed on the opposite side. The second step was a modified radical mastectomy, according to Madden, and the removal of the originally implanted pacemaker generator. Radiotherapy and hormonal adjuvant therapy were applied after surgery. The patient was followed-up at an out-patient clinic, and died 25 months after diagnosis because of generalization of the disease (Fig. 2, Ref. 35). Full Text (Free, PDF) www.bmj.sk.

Right versus left atrial pacing in patients with sick sinus syndrome and paroxysmal atrial fibrillation (Riverleft study): study protocol for randomized controlled trial.

PubMed

Ramdjan, Tanwier T T K; van der Does, Lisette J M E; Knops, Paul; Res, Jan C J; de Groot, Natasja M S

2014-11-17

The incidence of sick sinus syndrome will increase due to population ageing. Consequently, this will result in an increase in the number of pacemaker implantations. The atrial lead is usually implanted in the right atrial appendage, but this position may be ineffective for prevention of atrial fibrillation. It has been suggested that pacing distally in the coronary sinus might be more successful in preventing atrial fibrillation episodes. The aim of this trial is to study the efficacy of distal coronary sinus versus right atrial appendage pacing in preventing atrial fibrillation episodes in patients with sick sinus syndrome. This study is designed as a multicenter, randomized controlled trial. Patients with sick sinus syndrome and at least one atrial fibrillation episode of 30 seconds or more in the six months before recruitment will be eligible for participation in this study.All participants will be randomized between pacing distally in the coronary sinus and right atrial appendage. Randomization is stratified for all participating centers. Conventional dual-chamber pacemakers with advanced home monitoring functionality will be implanted. The ventricular lead will be implanted in the right ventricular apex. The first three months of the 36-month follow-up period are considered as run-in time. During the pre-randomization visit and follow-up, an interview, electrocardiogram and pacemaker assessment will be performed, prescribed antiarrhythmic medication will be reviewed and patients will be asked to complete an SF-36 questionnaire. An echocardiographic examination will be conducted in the pre-randomization phase and at the end of each follow-up year. Home monitoring will be used to send daily reports in case of atrial fibrillation episodes. This randomized controlled trial is the first in which home monitoring will be used to compare atrial fibrillation recurrences between pacing in the distal coronary sinus or right atrial appendage. Home monitoring gives the opportunity to accurately detect atrial fibrillation episodes and to study characteristics of atrial fibrillation episodes. Should distal coronary sinus pacing significantly diminish atrial fibrillation recurrences, this study will redefine the preferential location of an atrial lead for preventive pacing. Current Controlled Trials ISRCTN65911661, registered on 8 July 2013.

Implantable Medical Devices

MedlinePlus

... Also known as ICD ) - An ICD is a battery-powered device placed under the skin that keeps ... Pacemaker (Also known as Artificial Pacemaker) - A small battery-operated device that helps the heart beat in ...

Engineered Biological Pacemakers | NCI Technology Transfer Center | TTC

Cancer.gov

The National Institute on Aging's Cellular Biophysics Section is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize biological pacemakers.

Sick Sinus Syndrome

MedlinePlus

... rhythm problems (arrhythmias) in which the heart's natural pacemaker (sinus node) doesn't work properly. The sinus ... people with sick sinus syndrome eventually need a pacemaker to keep the heart in a regular rhythm. ...

Sick sinus syndrome

MedlinePlus

... the heart (atria). This area is the heart's pacemaker. It may be called the sinoatrial node, sinus ... do so. You may need a permanent implanted pacemaker if your symptoms are related to bradycardia (slow ...

Non-lead hollow point bullet

DOEpatents

Vaughn, Norman L.; Lowden, Richard A.

2003-04-15

The non-lead hollow point bullet of the instant invention comprises a mixed construction slug further comprising, a monolithic metal insert having a tapered (preferred conical) hollow point tip and a tapered (preferred conical) tail protrusion, and an unsintered powdered metal composite core in tandem alignment with the insert. The core has a hollow tapered (preferred conical) cavity tip portion coupled with the tapered (preferred conical) tail protrusion on the insert. An open tip jacket envelops at least a portion of the insert and the core. The jacket is swaged at the open tip.

Pacemaker

MedlinePlus

... check for changes in your heart's electrical activity. Battery Replacement Pacemaker batteries last between 5 and 15 years (average 6 ... doctor will replace the generator along with the battery before the battery starts to run down. Replacing ...

Implantable cardioverter defibrillator - discharge

MedlinePlus

... defibrillation. This device can also work as a pacemaker. What to Expect at Home When you leave ... pubmed/23265327 . Swerdlow CD, Wang PL, Zipes DP. Pacemakers and implantable cardioverter-defibrillators. In: Mann DL, Zipes ...

Centrifuge-simulated suborbital spaceflight in subjects with cardiac implanted devices.

PubMed

Blue, Rebecca S; Reyes, David P; Castleberry, Tarah L; Vanderploeg, James M

2015-04-01

Future commercial spaceflight participants (SFPs) with conditions requiring personal medical devices represent a unique challenge. The behavior under stress of cardiac implanted devices (CIDs) such as pacemakers is of special concern. No known data currently exist on how such devices may react to the stresses of spaceflight. We examined the responses of two volunteer subjects with CIDs to G forces in a centrifuge to evaluate how similar potential commercial SFPs might tolerate the forces of spaceflight. Two subjects, 75- and 79-yr-old men with histories of atrial fibrillation and implanted dual-lead, rate-responsive pacemakers, underwent seven centrifuge runs over 2 d. Day 1 consisted of two +Gz runs (peak = +3.5 Gz, run 2) and two +Gx runs (peak = +6.0 Gx, run 4). Day 2 consisted of three runs approximating suborbital spaceflight profiles (combined +Gx/+Gz). Data collected included blood pressures, electrocardiograms, pulse oximetry, neurovestibular exams, and postrun questionnaires regarding motion sickness, disorientation, greyout, and other symptoms. Despite both subjects' significant medical histories, neither had abnormal physiological responses. Post-spin analysis demonstrated no lead displacement, damage, or malfunction of either CID. Potential risks to SFPs with CIDs include increased arrhythmogenesis, lead displacement, and device damage. There are no known prior studies of individuals with CIDs exposed to accelerations anticipated during the dynamic phases of suborbital spaceflight. These cases demonstrate that even individuals with significant medical histories and implanted devices can tolerate the acceleration exposures of commercial spaceflight. Further investigation will determine which personal medical devices present significant risks during suborbital flight and beyond.

In vitro assessment of tissue heating near metallic medical implants by exposure to pulsed radio frequency diathermy

NASA Astrophysics Data System (ADS)

Ruggera, P. S.; Witters, D. M.; von Maltzahn, G.; Bassen, H. I.

2003-09-01

A patient with bilateral implanted neurostimulators suffered significant brain tissue damage, and subsequently died, following diathermy treatment to hasten recovery from teeth extraction. Subsequent MRI examinations showed acute deterioration of the tissue near the deep brain stimulator (DBS) lead's electrodes which was attributed to excessive tissue heating induced by the diathermy treatment. Though not published in the open literature, a second incident was reported for a patient with implanted neurostimulators for the treatment of Parkinson's disease. During a diathermy treatment for severe kyphosis, the patient had a sudden change in mental status and neurological deficits. The diathermy was implicated in causing damage to the patient's brain tissue. To investigate if diathermy induced excessive heating was possible with other types of implantable lead systems, or metallic implants in general, we conducted a series of in vitro laboratory tests. We obtained a diathermy unit and also assembled a controllable laboratory exposure system. Specific absorption rate (SAR) measurements were performed using fibre optic thermometry in proximity to the implants to determine the rate of temperature rise using typical diathermy treatment power levels. Comparisons were made of the SAR measurements for a spinal cord stimulator (SCS) lead, a pacemaker lead and three types of bone prosthesis (screws, rods and a plate). Findings indicate that temperature changes of 2.54 and 4.88 °C s-1 with corresponding SAR values of 9129 and 17 563 W kg-1 near the SCS and pacemaker electrodes are significantly higher than those found in the proximity of the other metallic implants which ranged from 0.04 to 0.69 °C s-1 (129 to 2471 W kg-1). Since the DBS leads that were implanted in the reported human incidents have one-half the electrode surface area of the tested SCS lead, these results imply that tissue heating at rates at least equal to or up to twice as much as those reported here for the SCS lead could occur for the DBS leads.

Method of joining a vane cavity insert to a nozzle segment of a gas turbine

DOEpatents

Burdgick, Steven Sebastian

2002-01-01

An insert containing apertures for impingement cooling a nozzle vane of a nozzle segment in a gas turbine is inserted into one end of the vane. The leading end of the insert is positioned slightly past a rib adjacent the opposite end of the vane through which the insert is inserted. The end of the insert is formed or swaged into conformance with the inner margin of the rib. The insert is then brazed or welded to the rib.

From Pacemaker to Wearable: Techniques for ECG Detection Systems.

PubMed

Kumar, Ashish; Komaragiri, Rama; Kumar, Manjeet

2018-01-11

With the alarming rise in the deaths due to cardiovascular diseases (CVD), present medical research scenario places notable importance on techniques and methods to detect CVDs. As adduced by world health organization, technological proceeds in the field of cardiac function assessment have become the nucleus and heart of all leading research studies in CVDs in which electrocardiogram (ECG) analysis is the most functional and convenient tool used to test the range of heart-related irregularities. Most of the approaches present in the literature of ECG signal analysis consider noise removal, rhythm-based analysis, and heartbeat detection to improve the performance of a cardiac pacemaker. Advancements achieved in the field of ECG segments detection and beat classification have a limited evaluation and still require clinical approvals. In this paper, approaches on techniques to implement on-chip ECG detector for a cardiac pacemaker system are discussed. Moreover, different challenges regarding the ECG signal morphology analysis deriving from medical literature is extensively reviewed. It is found that robustness to noise, wavelet parameter choice, numerical efficiency, and detection performance are essential performance indicators required by a state-of-the-art ECG detector. Furthermore, many algorithms described in the existing literature are not verified using ECG data from the standard databases. Some ECG detection algorithms show very high detection performance with the total number of detected QRS complexes. However, the high detection performance of the algorithm is verified using only a few datasets. Finally, gaps in current advancements and testing are identified, and the primary challenge remains to be implementing bullseye test for morphology analysis evaluation.

Reciprocal cholinergic and GABAergic modulation of the small ventrolateral pacemaker neurons of Drosophila's circadian clock neuron network.

PubMed

Lelito, Katherine R; Shafer, Orie T

2012-04-01

The relatively simple clock neuron network of Drosophila is a valuable model system for the neuronal basis of circadian timekeeping. Unfortunately, many key neuronal classes of this network are inaccessible to electrophysiological analysis. We have therefore adopted the use of genetically encoded sensors to address the physiology of the fly's circadian clock network. Using genetically encoded Ca(2+) and cAMP sensors, we have investigated the physiological responses of two specific classes of clock neuron, the large and small ventrolateral neurons (l- and s-LN(v)s), to two neurotransmitters implicated in their modulation: acetylcholine (ACh) and γ-aminobutyric acid (GABA). Live imaging of l-LN(v) cAMP and Ca(2+) dynamics in response to cholinergic agonist and GABA application were well aligned with published electrophysiological data, indicating that our sensors were capable of faithfully reporting acute physiological responses to these transmitters within single adult clock neuron soma. We extended these live imaging methods to s-LN(v)s, critical neuronal pacemakers whose physiological properties in the adult brain are largely unknown. Our s-LN(v) experiments revealed the predicted excitatory responses to bath-applied cholinergic agonists and the predicted inhibitory effects of GABA and established that the antagonism of ACh and GABA extends to their effects on cAMP signaling. These data support recently published but physiologically untested models of s-LN(v) modulation and lead to the prediction that cholinergic and GABAergic inputs to s-LN(v)s will have opposing effects on the phase and/or period of the molecular clock within these critical pacemaker neurons.

A novel method of placing right ventricular leads in patients with persistent left superior vena cava using a conventional j stylet.

PubMed

Mora, Guillermo

2014-03-01

Locating pacemaker electrodes can become complicated by congenital abnormalities such as persistent left superior vena cava (LSVC). To evaluate a technique for the implanting of ventricular electrode in patients with persistent LSVC. The study was carried out from June 2001 to June 2010 involving all patients who were admitted to the Hospital Universitario Mayor, Instituto de Corazon de Bogota and Hospital Universitario Clinica San Rafael (Bogota-Colombia) for implanting pacemakers or cardiac defibrillators. LSVC was diagnosed by fluoroscopic observation (anterior-posterior view) of the course of the stylet. Four steps were followed: 1) Move the electrode with a straight stylet to the right atrium. 2) Change the straight stylet by a conventional J stylet and push the electrode to the lateral or anterolateral wall of the right atrium. 3) Remove the guide 3-5 cm and 4) Push the electrode which crosses the tricuspid valve into the right ventricle and finally deploy the active fixation mechanism. A total of 1198 patients were admitted for pacemaker or cardiac defibrillator implant during the 9-year study period, 1114 received a left subclavian venous approach. There were 573 males and 541 females. Persistent LSVC was found in five patients (0.45%) Fluoroscopy time for implanting the ventricular electrode ranged from 60 to 250 seconds, 40 to 92 minutes being taken to complete the whole procedure. We present a simple and rapid technique for electrode placement in patients with LSVC using usual J guide and active fixation electrodes with high success.

[Cardiac resynchronization therapy for heart failure - from experimental pacing to evidence-based therapy].

PubMed

Götze, S; Butter, C; Fleck, E

2006-01-01

Within the last decade, cardiac resynchronization therapy (CRT) has become an evidence-based cornerstone for a subset of patients with chronic heart failure. For those, who suffer from ischemic or non-ischemic cardiomyopathies at NYHA III or IV, have sinus rhythm, a left bundle branch block and a left ventricular ejection fraction below 35%, CRT has evolved as an important treatment option with promising results. Numerous studies have shown that in these patients pacemaker-mediated correction of intra- and interventicular conduction disturbances can improve not only clinical symptoms, exercise tolerance and the frequency of hospitalizations, but even more important the overall mortality. These clinical results are due to several functional aspects. In the failing heart characteristic intra- and interventricular alterations in electrical conduction result in mechanical asynchrony that leads to an abnormal contraction of the left ventricle with delayed activation of the lateral wall, a paradoxical septal movement, a reduced diastolic filling and a mitral regurgitation due to dyssynchrony of papillary muscle activation. It is conceivable that these functional changes have fatal consequences for the failing heart. AV-optimized left- or biventricular stimulation by modern pacemakers can correct the pathological dyssynchrony, thereby improving cardiac function and clinical outcome in these patients. Although tremendous progress in cardiac resynchronization therapy has been made during the last decade, a couple of questions still need to be resolved. Critical issues are the identification of patients, who will predictably benefit from CRT, the value of CRT-pacemakers versus CRT-ICDs, and the usefullness of CRT in patients with atrial fibrillation.

Randomized placebo controlled blinded study to assess valsartan efficacy in preventing left ventricle remodeling in patients with dual chamber pacemaker--Rationale and design of the trial.

PubMed

Tomasik, Andrzej; Jacheć, Wojciech; Wojciechowska, Celina; Kawecki, Damian; Białkowska, Beata; Romuk, Ewa; Gabrysiak, Artur; Birkner, Ewa; Kalarus, Zbigniew; Nowalany-Kozielska, Ewa

2015-05-01

Dual chamber pacing is known to have detrimental effect on cardiac performance and heart failure occurring eventually is associated with increased mortality. Experimental studies of pacing in dogs have shown contractile dyssynchrony leading to diffuse alterations in extracellular matrix. In parallel, studies on experimental ischemia/reperfusion injury have shown efficacy of valsartan to inhibit activity of matrix metalloproteinase-9, to increase the activity of tissue inhibitor of matrix metalloproteinase-3 and preserve global contractility and left ventricle ejection fraction. To present rationale and design of randomized blinded trial aimed to assess whether 12 month long administration of valsartan will prevent left ventricle remodeling in patients with preserved left ventricle ejection fraction (LVEF ≥ 40%) and first implantation of dual chamber pacemaker. A total of 100 eligible patients will be randomized into three parallel arms: placebo, valsartan 80 mg/daily and valsartan 160 mg/daily added to previously used drugs. The primary endpoint will be assessment of valsartan efficacy to prevent left ventricle remodeling during 12 month follow-up. We assess patients' functional capacity, blood plasma activity of matrix metalloproteinases and their tissue inhibitors, NT-proBNP, tumor necrosis factor alpha, and Troponin T. Left ventricle function and remodeling is assessed echocardiographically: M-mode, B-mode, tissue Doppler imaging. If valsartan proves effective, it will be an attractive measure to improve long term prognosis in aging population and increasing number of pacemaker recipients. ClinicalTrials.org (NCT01805804). Copyright © 2015 Elsevier Inc. All rights reserved.

Prevention and Treatment of Arrhythmia

MedlinePlus

... your pulse – especially if you have an artificial pacemaker. Put the second and third fingers of one ... Ablation Devices for Arrhythmia - Implantable Cardioverter Defibrillator (ICD) - Pacemaker Treating Arrhythmias in Children • Arrhythmia Tools & Resources Watch, ...

[Hyperkalemia-induced failure of pacemaker capture and sensing: a case report].

PubMed

Wang, Y P; Chen, B X; Su, K J; Sun, L J; Zhang, Y; Guo, L J; Gao, W

2014-12-18

Hyperkalemia may induce serious cardiac arrhythmia, with possible life-threatening effects. It may cause cardiac pacemaker (PMK) malfunctioning due to a reduction of the electronegativity of the resting myocardial potential. We report the case of a 71-year-old woman who had a previous history of chronic heart failure, chronic renal failure and DDI pacemaker. She was admitted for disturbance of consciousness. During hospitalization, she was observed for extreme hypotension, acute hyperkalemia, ventricular escape rhythm, associated with failure of pacemaker capture and sensing. She was treated with calcium chloride injection, followed by insulin/glucose and sodium bicarbonate infusions; the electrocardiogram recordings showed an correction of the PMK malfunctioning and serial improvement of the intraventricular conduction. This case supports that hyperkalemia should be closely monitored in the chronic heart failure patients combined with chronic renal failure.