Single chamber pacemaker atrial fibrillation

02 January 2019

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[Dual chamber pacemaker in the treatment of paroxysmal atrial fibrillation].

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The possible complications, such as perforation of the heart wall, come from removing the leads from the patient's body. A substantial external device using technology to provide , it was somewhat crude and painful to the patient in use and, being powered from an AC wall socket, carried a potential hazard of of the patient and inducing. Case Reports in Cardiology.

Primary outcome was death from any cause or nonfatal stroke. Castelnuovo E, Stein K, Pitt M, Garside R, Payne E. Dynamic pacemaking technology could also be applied to future.

[Dual chamber pacemaker in the treatment of paroxysmal atrial fibrillation]. - Some people even lose consciousness.

NOTE: You either have javascript disabled or have saved the page locally. Your experience may not be optimal due to these factors. Please consider enabling javascript or revisiting to get an optimal MCD experience. Symptoms of bradycardia are symptoms that can be directly attributable to a heart rate less than 60 beats per minute for example: syncope, seizures, congestive heart failure, dizziness, or confusion. Medicare Administrative Contractors will determine coverage under section 1862 a 1 A of the Social Security Act for any other indications for the implantation and use of single chamber or dual chamber cardiac pacemakers that are not specifically addressed in this national coverage determination. To: Administrative File: CAG-00063R3 From: Louis Jacques, MD Director, Coverage and Analysis Group Tamara Syrek Jensen, JD Deputy Director, Coverage and Analysis Group Jyme Schafer, MD, MPH Director, Division of Medical and Surgical Services Joseph Chin, MD, MS Lead Medical Officer Jamie Hermansen, MPP Lead Health Policy Analyst Subject: Decision Memorandum for Reconsideration of Coverage of Cardiac Pacemakers: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers. Date: August 13, 2013 I. Symptoms of bradycardia are symptoms that can be directly attributable to a heart rate less than 60 beats per minute for example: syncope, seizures, congestive heart failure, dizziness, or confusion. Medicare Administrative Contractors will determine coverage under section 1862 a 1 A of the Social Security Act for any other indications for the implantation and use of single chamber or dual chamber cardiac pacemakers that are not specifically addressed in this national coverage determination. Background Throughout this document we use numerous acronyms, some of which are not defined as they are presented in direct quotations. Please find below a list of these acronyms and corresponding full terminology. ACC — American College of Cardiology ACCF — American College of Cardiology Foundation AF — atrial fibrillation AHA — American Heart Association AV — atrioventricular AVB — atrioventricular block BPEG — British Pacing and Electrophysiology Group bpm — beats per minute CTOPP — Canadian Trial of Physiologic Pacing HAS — Haute Autorité de Santé French: High Authority for Health HRS — Heart Rhythm Society LA — left atrial LV — left ventricular LVFS — left ventricular fractional shortening MOST — Mode Selection Trial NASPE — North American Society of Pacing and Electrophysiology now known as the Heart Rhythm Society PASE — Pacemaker Selection in the Elderly PR — pulse rate RCT — randomized controlled trial SND — sinus node dysfunction SSS — sick sinus syndrome UKPACE — United Kingdom Pacing and Cardiovascular Events Nomenclature for cardiac pacemaker mode selection is also referenced throughout this document. The pacing mode codes currently in use were originally published in 1987 and updated in 2002. Positions I, II, and III indicate the heart chambers where pacing and sensing occur. Position IV is used to indicate the presence or absence of an adaptive-rate mechanism, and Position V indicates whether multi-site pacing is present Bernstein et al. CMS initiated this current national coverage analysis to reconsider coverage indications for single chamber and dual chamber cardiac pacemakers. The scope of this reconsideration and this decision memorandum does not address biventricular pacemakers, pacemakers that stimulate more than two heart chambers, those devices used to treat tachyarrhythmias and cardiac dissynchrony, cardiac resynchronization therapy, cardiac pacemaker evaluation services, or self-contained pacemaker monitors. Permanent cardiac pacemakers refer to a group of self-contained, battery operated, implanted devices that send electrical stimulation to the heart through one or more implanted leads. Pacemakers are most often used to treat chronic cardiac arrhythmias abnormalities in the rate and rhythm of heart beats such as bradycardia a heart rate usually less than 60 beats per minute bpm or tachycardia a heart rate faster than 100 or more bpm that are pathologic. Bradycardia can be generally divided into sinus node dysfunction SND and atrioventricular AV conduction disturbances or blocks AVB Mangrum and DiMarco, 2000. In the normal heart beat, the sinus node depolarizes and initiates atrial contraction P wave on the electrocardiogram. Depolarization travels from the atrium through the AV node into the Bundle of His and the bundle branches, initiating ventricular contraction QRS complex Noble, Hillis and Rothbaum, 1990; see Appendix D. Together SND and AVB account for the majority of implantations of permanent cardiac pacemakers 86 percent Bernstein, 2001. SND, also known as sick sinus syndrome SSS , may involve abnormalities in the sinus node itself or exit blocks and may be due to intrinsic disease of the nodal tissue due to degeneration or infarction or extrinsic factors such as medications. SND is relatively common in adults 65 years or older Mangrum and DiMarco, 2000. These blocks and those with a conduction ratio of 3:1 or higher are categorized as advanced Ginter JF, 2011. They are often classified by the number of chambers of the heart that the devices stimulate pulse or depolarize. Single chamber pacemakers typically target either the right atrium or right ventricle. Dual chamber pacemakers stimulate both the right atrium and right ventricle. The implantation procedure is typically performed under local anesthesia and requires only a brief hospitalization. A catheter is inserted into the chest and the pacemaker's leads are threaded through the catheter to the appropriate chamber s of the heart. The pocket is then closed with stitches. The procedure leaves a small scar and the battery can be felt through the skin. With technological advancements, the use of dual chamber permanent cardiac pacemakers has dramatically increased over the past several years. Greenspon and colleagues reported that overall use of pacemakers increased by 55. Several trials and evidence reviews on single and dual chamber pacemakers have been completed and reported since the NCD for cardiac pacemakers was originally established. Professional society guidelines have also been presented and revised over the years. History of Medicare Coverage Section 20. This NCD establishes conditions of coverage and non-coverage for permanent single chamber and dual chamber cardiac pacemakers. In June 2000, Medtronic requested that CMS review the use of cardiac pacemakers to treat asymptomatic bradycardia in post-MI patients about to initiate long-term ß-blocker drug therapy. After a complete systematic review of the evidence provided, CMS posted a coverage decision memorandum on March 20, 2001, that maintained the non-coverage NCD that pacemaker implantation would not be considered reasonable and necessary in these patients. The NCD was last updated in 2004 when CMS issued a decision memorandum to focus the NCD on the indications for pacemaker use rather than on the pacemaker implantation procedure. CMS only changed the framework of the NCD and did not review the specific provisions setting forth conditions that indicate that cardiac pacing is reasonable and necessary. Current Reconsideration CMS received a formal external joint request from HRS and the American College of Cardiology ACC for reconsideration of dual-chamber pacemaker coverage. The request outlined differences between clinical guidelines and current Medicare coverage policy, focusing on revisions to the clinical indications for dual-chamber pacemakers. Benefit Category Medicare is a defined benefit program. An item or service must meet one of the statutorily defined benefit categories in the Social Security Act and not otherwise be excluded. Thus, cardiac pacemakers qualify as a benefit. Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service. Timeline of Recent Activities Date Action Date Action January 24, 2013 CMS initiates this national coverage analysis for reconsideration of Section 20. The initial 30-day public comment period began with this posting date. February 23, 2013 The initial 30-day public comment period ended. CMS received 98 comments. May 29, 2013 CMS posted the proposed decision memorandum. The 30-day public comment period began with this posting date. June 28, 2013 The 30-day public comment period ended. CMS received 50 comments. If a device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing. For Class III devices, a premarket approval application PMA is required for marketing. Pacemakers that are currently developed which are considered similar to predicate devices are cleared through the 510k process. The FDA approves pacemakers for sino-atrial node dysfunction e. General Methodological Principles When making national coverage determinations under §1862 a 1 A , CMS generally evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service falling within a benefit category is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. The critical appraisal of the evidence enables us to determine to what degree we are confident that: 1 the specific assessment questions can be answered conclusively; and 2 the intervention will improve health outcomes for patients. An improved health outcome is one of several considerations in determining whether an item or service is reasonable and necessary. A detailed account of the methodological principles of study design that the agency utilizes to assess the relevant literature on a therapeutic or diagnostic item or service for specific conditions can be found in Appendix A. In general, features of clinical studies that improve quality and decrease bias include the selection of a clinically relevant cohort, the consistent use of a single good reference standard, the blinding of readers of the index test, and reference test results. Public comments sometimes cite the published clinical evidence and give CMS useful information. Public comments that give information on unpublished evidence such as the results of individual practitioners or patients are less rigorous and therefore less useful for making a coverage determination. Public comments that contain personal health information PHI will be redacted and the PHI will not be made available to the public. CMS uses the initial public comments to inform its proposed decision. CMS responds in detail to the public comments on a proposed decision when issuing the final decision memorandum. Introduction In this coverage analysis, we considered evidence for single or dual chamber permanent cardiac pacemakers for the treatment of symptomatic bradycardia. Important health outcomes include mortality, morbidity including adverse events , and quality of life QOL. Increased survival has been demonstrated with initial use of single chamber pacemakers. The first patient to receive an implanted pacemaker was able to leave the hospital and lead a moderately active life for more than two years after receiving the implant. Given the past research and evidence on survival from use of permanent pacemakers, our analysis focuses on mortality, but also emphasizes other health outcomes. We note that while quality of life is an important health outcome, it is more difficult to objectively measure and discern potential bias in the reported studies. Literature Search CMS searched PubMed from February 2004 date of the last NCD to December 2012 using key words pacemakers, single and dual. Observational studies with sample sizes less than 50 cases were excluded as they may have inherent biases that substantially limit generalizability. Abstracts, presentations, and articles not written in English were also excluded. In addition to our search, the requestors submitted 100 article summaries which were reviewed; seventeen articles met our criteria and were included in our review five randomized trials, one randomized controlled comparison, one technology appraisal, one meta-analysis, two evidence reviews, one follow-up analysis of a randomized trial, one registry analysis, one secondary outcome analysis, three evidence-based guidelines, and one consensus statement. CMS does not consider cost when developing NCDs under §1862 a 1 A. Discussion of Evidence Reviewed Question: Is the evidence sufficient to determine that implantation and use of permanent single chamber or dual chamber cardiac pacemakers improve health outcomes in Medicare beneficiaries? External technology assessment Castelnuovo E, Stein K, Pitt M, Garside R, Payne E. The effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber pacemakers for bradycardia due to atrioventricular block or sick sinus syndrome: systematic review and economic evaluation. Health Technol Assess 2005;9 43. Eligible studies were systematic reviews and randomized trials. Non-randomized studies, case control, and cohort studies were excluded. Outcomes were mortality all-cause and cardiovascular , stroke, atrial fibrillation AF , heart failure, exercise capacity, symptoms of breathlessness, fatigue, chest pain, dizziness, palpitations, sleep disturbance, functional status, QOL, adverse events of implantation perioperative mortality and non-fatal complications , and pacemaker syndrome. Two evidence reviews, four parallel group randomized controlled trials RCTs the Canadian Trial of Physiologic Pacing CTOPP , the Mode Selection Trial MOST , the Pacemaker Selection in the Elderly PASE , and United Kingdom Pacing and Cardiovascular Events UKPACE and 28 cross-over trials were included in the evidence review. Higher rates of atrial fibrillation were seen with dual-chamber pacing than with atrial pacing. Complications occurred more frequently in dual-chamber pacemaker insertion. Dual chamber versus single chamber ventricular pacemakers for sick sinus syndrome and atrioventricular block. Cochrane Database of Systematic Reviews 2004, Issue 2. Up to year 2002, five parallel CTOPP, MOST, PASE, 1 trial on tachyarrhythmia, 1 trial on AF and 26 cross-over randomized controlled trials were included in the review. Both parallel and crossover studies favour dual chamber pacing with regard to pacemaker syndrome parallel: Peto OR 0. Pooled data from crossover studies shows a statistically significant trend towards dual chamber pacing being more favourable in terms of exercise capacity SMD -0. No individual studies reported a significantly more favourable outcome with single chamber ventricular pacing. Additional randomised controlled trial evidence from ongoing trials in this area will further inform the debate. Single or dual-chamber pacemakers? The guidelines of the HAS. Archives of Cardiovascular Diseases Supplements. There was a significant reduction in the composite outcome of stroke or cardiovascular mortality, but only among patients with SSS. Results of QOL, exercise capacity, functional status and pacemaker syndrome are variable. Dual-chamber pacemakers DDDR have to be reserved for 2 situations: i SSS with evidence of impaired atrioventricular conduction, ii permanent AVB without AF. HAS will not recommend that pacemakers with specific algorithms for minimal ventricular pacing be systematically used instead of single-chamber pacemakers in patients presenting with SSS or paroxysmal AVB, unless more clinical trials are performed. Cardiovascular outcomes with atrial-based pacing compared with ventricular pacing: meta-analysis of randomized trials, using individual patient data. Epub 2006 Jun 26. Randomized trials from 1990 were included. Trials on multisite pacing and follow-up less than six months were excluded. Outcomes were clinical events, mortality, stroke, heart failure, and AF. Mean age of participants in the trials ranged from 73 to 80 years. There was a significant reduction in atrial fibrillation HR, 0. However, atrial-based pacing reduces the incidence of atrial fibrillation and may modestly reduce stroke. Internal technology assessment Connolly SJ, Kerr CR, Gent M, Roberts RS, Yusuf S, Gillis AM, Sami MH, Talajic M, Tang AS, Klein GJ, Lau C, Newman DM. Effects of physiologic pacing versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. Canadian Trial of Physiologic Pacing Investigators. N Engl J Med. Primary outcome was the occurrence of either stroke or death due to cardiovascular causes. Secondary outcomes were death from any cause, documented AF, and congestive heart failure hospitalization. A total of 1474 patients were randomly assigned to receive a ventricular pacemaker and 1094 to a physiologic pacemaker dual-chamber, atrial and ventricular. Mean age at baseline was 73 years. Men comprised 59 percent of the study population. AVB was the most common indication for pacing. Sinoatrial node disease was present in 40 percent of patients. Mean follow-up was three years. Atrial fibrillation and quality of life after pacemaker implantation for sick sinus syndrome; data from the Mode Selection Trial MOST. Fleischmann and colleagues reported the results of a specific analysis of QOL as a pre-specified secondary outcome of the Mode Selection Trial MOST; see primary results reported by Lamas, 2002. QOL was measured with the Medical Outcomes Study 36-Item Short Form SF-36 General Health Survey at baseline, three months, 12 months, 24 months, 36 months, and 48 months. The mode selected was associated with much smaller, but significant, improvements in several domains, particularly role physical function. Epub 2008 May 7. Of the 8777 patients in the analysis, 2685 received atrial pacing AAI; 30. Eighty-seven percent of the patients were 60 years or older. Men comprised 47 percent of the cohort. Mean follow-up was four years for AAI patients and 2. Canadian Trial of Physiological Pacing: Effects of physiological pacing during long-term follow-up. Epub 2004 Jan 5. Of the 2568 patients randomized in CTOPP, 1995 were eligible for the extended follow-up study with 94. The primary outcome was the composite of cardiovascular death or stroke. Secondary outcomes were overall mortality, stroke, and new development of AF. Mean follow-up of the combined CTOPP and extended study was 6. However, there is a persistent significant reduction in the development of atrial fibrillation with physiological pacing. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. Patients with serious comorbidities study site determined were excluded. Primary outcome was death from any cause or nonfatal stroke. Prespecified secondary outcomes included cardiovascular mortality, AF and QOL. From September 1995 to October 1999, 2010 patients were enrolled at 91 sites. All patients received a dual chamber, rate modulated pacemaker but the device programming varied with assignment. Median age was 74 years. Men comprised 52 percent of the study population. Median follow-up was 33. However, dual chamber pacing reduces the risk of atrial fibrillation, reduces signs and symptoms of heart failure, and slightly improves the quality of life. Overall, dual chamber pacing offers significant improvement as compared with ventricular pacing. Quality of life and clinical outcomes in elderly patients treated with ventricular pacing as compared with dual-chamber pacing. Pacemaker Selection in the Elderly Investigators. N Engl J Med. Lamas and colleagues reported the results of a randomized, controlled comparison of ventricular pacing and dual chamber pacing to assess the effect of the pacing mode on the health-related QOL of older adults. Inclusion criteria were age of 65 years or older, sinus rhythm, and a permanent pacemaker requirement for bradycardia. Exclusion criteria were inability to participate in the QOL assessments, clinically overt congestive heart failure at the time of implantation, AF without any documented sinus mechanism for more than six months, serious non-cardiac illness, and inadequate atrial-capture or sensing thresholds. Primary outcome was multidimensional health-related QOL measured with the 36-item Medical Outcomes Study Short-Form General Health Survey SF-36 at three, nine and 18 months. All patients received dual chamber rate-adaptive pacemakers, but the device programming varied with assignment. Mean age was 76 years. Men comprised 60 percent of the study population. Primary outcome was death from any cause. Secondary outcomes included paroxysmal AF, chronic AF, stroke, peripheral embolism, heart failure and pacemaker re-operation. Mean age was 73 years. Men comprised 35 percent of the study population. Mean follow-up was five years. The authors did not detect significant differences in death 29. AAIR pacing is associated with a higher incidence of paroxysmal atrial fibrillation and a two-fold increased risk of pacemaker reoperation. These findings support the routine use of DDDR pacing in these patients. Single-chamber versus dual-chamber pacing for high-grade atrioventricular block. N Engl J Med. Toff and colleagues reported the results of a randomized trial to compare the clinical benefits of single chamber ventricular pacing and dual chamber pacing in elderly patients with AVB. Patients were 70 years of age or older and were scheduled to receive their first pacemakers for high-grade second-degree or complete AVB. Mean age was 80 years. Men comprised 57 percent of the study population. We found no significant differences between the group with single-chamber pacing and that with dual-chamber pacing in the rates of atrial fibrillation, heart failure, or a composite of stroke, transient ischemic attack, or other thromboembolism. Evidence-based guidelines Epstein AE, Dimarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Society of Thoracic Surgeons. Epub 2008 May 21. Epstein AE, DiMarco JP, Ellenbogen KA, Estes NAM III, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO. In 2008, ACC, AHA, and HRS published evidence-based guidelines on device-based therapy for arrhythmias. Recommendations were reported for arrhythmias as well as device selection. Table 2 reproduced below presented indications for single chamber and dual chamber pacemakers. National Institute for Clinical Excellence. A total of 32 studies of dual chamber pacemakers versus single chamber ventricular pacemakers were identified. Guidelines for cardiac pacing and cardiac resynchronization therapy: The Task Force for Cardiac Pacing and Cardiac Resynchronization Therapy of the European Society of Cardiology. Developed in collaboration with the European Heart Rhythm Association. Epub 2007 Aug 28. The European Society of Cardiology and European Heart Rhythm Association jointly published guidelines for cardiac pacing. For sinus node disease, the recommendations are below copy of Table 1. Developed in partnership between the Heart Rhythm Society HRS and the American College of Cardiology Foundation ACCF and in collaboration with the Society of Thoracic Surgeons, Heart Rhythm, 2012 Aug;9 8 :1344-65, doi: 10. Gillis AM, Russo AM, Ellenbogen KA, Swerdlow CD, Olshansky B, Al-Khatib SM, Beshai JF, McComb JM, Nielsen JC, Philpott JM, Shen WK. J Am Coll Cardiol. Epub 2012 Jul 30. These include, but are not limited to, sedentary patients, those with significant medical comorbidities likely to impact clinical outcomes, and those in whom technical issues, such as vascular access limitations, preclude or increase the risk of placing an atrial lead Level of Evidence: B. Public Comments The comments can be viewed in their entirety on our website at. Of the 80 comments, 42 were form letter submissions. Five comments also included suggested changes for coverage of single chamber pacemakers. One commenter did not support modification of the current NCD. Three comments did not express a position regarding modification of the NCD, but raised issues about coding and enforcement of existing policy. Public Comments on the Proposed Decision Memorandum We received 50 comments on the proposed decision from various entities including physician specialty societies, hospitals, health networks, physicians, community health networks, a health policy association, device manufacturers, and the general public. Forty-nine 49 comments supported the proposed decision, with nine of those comments suggesting modifications to the proposed covered and non-covered indications. One comment opposed the proposed decision. Three comments included references to guidelines, consensus statements, and articles that were previously included in our review of the evidence. Among the three comments that furnished references, one included a reference to the NCD for implantable cardiac defibrillators, which is outside the scope of this analysis. Another commenter included references to general clinical articles on medical management, which are not considered primary clinical research studies. The same commenter referenced articles that address topics that are outside the scope of this national coverage analysis. Specific issues and suggested modifications furnished by commenters are discussed below. Comment: Commenters opined that coverage was appropriate for patients with sinus node dysfunction and sick sinus syndrome. Response: In the background section of this decision memorandum we state that sinus node dysfunction is also known as sick sinus syndrome; we believe these terms to be synonymous. Based on the trials included in our analysis, we believe the evidence supports the use of permanent single chamber or dual chamber cardiac pacemakers for treatment of documented symptomatic bradycardia due to SND. Comment: Commenters requested coverage for asymptomatic second degree AVB of Mobitz Type I unless the QRS complexes are prolonged or electrophysiological studies have demonstrated that the block is at or beyond the level of the His Bundle a component of the electrical conduction system of the heart. Response: In general, individuals without symptoms are not treated with permanent implantable single chamber or dual chamber pacemakers. The patients in the studies we evaluated were symptomatic. Patients with progressive heart block may develop symptoms in the future that could lead to a patient having a covered indication. Based on our review of the published evidence, we did not find specific evidence to support coverage for this indication. Therefore, we are finalizing non-coverage for this indication. Response: We recognize that various arrhythmias may occur in patients with acute myocardial infarctions and that this indication has been covered for single chamber pacemakers under existing policy, meaning that patients may have received this treatment under certain circumstances. Comment: Commenters suggested that hypersensitive carotid sinus syndrome should be considered a covered indication based on consensus recommendations that stated permanent pacing is indicated for recurrent syncope caused by spontaneously occurring carotid sinus stimulation and carotid sinus pressure that induces ventricular asystole of more than three seconds Class I Recommendation, Level of Evidence C ; and permanent pacing is reasonable for syncope without clear, provocative events and with a hypersensitive cardioinhibitory response of three seconds or longer Class IIa Recommendation, Level of Evidence C. Commenters also suggested that we remove the example from one of the non-covered indications since it references hypersensitive carotid sinus syndrome. Response: Our covered indications do not specifically address hypersensitive carotid sinus syndrome, thus we are permitting local Medicare contractors to make the coverage determination for this indication under section 1862 a 1 A. In patients with atrial fibrillation, the P-R interval may be difficult to detect and relate to bradycardia. In this final decision, we are permitting local Medicare contractors to make the coverage determination under section 1862 a 1 A for this indication. Comment: One commenter suggested that patients with symptomatic reversible sinus bradycardia that results from required drug therapy for medical conditions should be covered. Response: Reversible causes of bradycardia such as electrolyte abnormalities, medications or drugs, or hypothermia are transient and not permanent in nature. The published evidence does not support permanent pacemaker implantation for conditions that are transient or not permanent in nature. Therefore, we are not making the requested change. Comment: Some commenters requested that we allow coverage for the non-covered indications when evaluated in Category B IDE clinical trials. Response: Local contractors are bound by national coverage determinations in their review of claims for payment, including evaluations for coverage in Category B IDE clinical trials. Nationally non-covered indications would not be coverable by local contractors. Based on the evidence reviewed, we are not making the requested change in this NCD. Medicare Administrative Contractors will determine coverage under section 1862 a 1 A of the Social Security Act for any other indications for the implantation and use of single chamber or dual chamber cardiac pacemakers that are not specifically addressed in this national coverage determination. Comment: Commenters requested coverage for patients with medically refractory symptomatic hypertrophic cardiomyopathy or provoked left ventricular outflow obstruction, and coverage for patients with recurrent and refractory ventricular tachycardia overdrive pacing — pacing above the basal rate to prevent ventricular tachycardia. Response: Overdrive pacing, generally considered to be related to the use of implanted cardiac defibrillators ICDs and treatment of medically refractory symptomatic hypertrophic cardiomyopathy were not considered. As discussed in the background section, the scope of this reconsideration and this coverage determination does not address biventricular pacemakers, pacemakers that stimulate more than two heart chambers, those devices used to treat tachyarrhythmias and cardiac dyssynchrony, cardiac resynchronization therapy, cardiac pacemaker evaluation services, or self-contained pacemaker monitors. Therefore, we believe these indications fall outside the scope of this national coverage analysis. Comment: Commenters disagreed with our assessment that dual chamber pacemakers are neither superior nor inferior to single chamber pacemakers and believe the statement should be deleted from the decision memorandum. Some suggested that we modify statements that address higher complication rates with dual chamber pacing. Response: Our statement was based on the trials included in our analysis that reported no difference in mortality, the primary outcome of interest, between single chamber and dual chamber cardiac pacemakers. As noted in the analysis, there is some indication of better secondary outcomes from use of dual chamber pacemakers compared to single chamber, although not uniformly significant. Health outcomes are comparable for patients who receive dual chamber pacemakers compared to those who receive single chamber pacemakers for symptomatic bradycardia but the choice of device may be influenced by the reduced rate of AF and higher perioperative complications seen with implantation of dual chamber pacemakers. We recognize the statement may be generally interpreted to apply to all outcomes whether primary or secondary and, therefore, have revised the analysis accordingly. Response: Shared decision making between the physician and patient remains important for device choice on an individual basis. We expect that physicians will carefully document the need for dual chamber pacemakers in the medical record, and that patients will be informed of the potentially higher complication rates following implantation of dual chamber devices as reported in the randomized controlled trials. The use of evidence-based guidelines and expert consensus statements may also help to inform the device selection process. While pacemaker longevity has increased over the past few decades, replacement of a permanent cardiac pacemaker is occasionally needed due to wear or damage to one or more components battery, generator, or leads. We did not find any specific evidence or recommendations on how to replace these devices or on which replacement devices should be used. Given the nature of the reasons for replacements, prudent clinical judgment should be used on an individual basis, along with documentation in the medical record on the initial indication for the pacemaker, the reason for replacement, and the justification of the type of replacement device selected. In rare instances, historical medical records may not be immediately available; however, adequate documentation should still be maintained to explain the existing circumstances and situation. Practitioners may wish to contact their local Medicare Administrative Contractors for additional guidance regarding medical record documentation. Comment: The majority of commenters requested that this coverage determination be applied retroactively three to five years due to concerns about enforcement of existing coverage requirements. Response: This NCD is effective for claims with dates of service on or after the date of the NCD. NCDs are not applied retroactively. CMS Analysis National coverage determinations NCDs are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally by Medicare §1862 l of the Social Security Act. In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwise excluded from coverage. Moreover, section 1862 a 1 of the Social Security Act in part states, with limited exceptions, no payment may be made under Part A or Part B for any expenses incurred for items or services, which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member §1862 a 1 A. As noted earlier, our review sought to answer the following question, which has been repeated here for the convenience of the reader. Is the evidence sufficient to determine that implantation and use of permanent single or dual chamber cardiac pacemakers improve health outcomes in Medicare beneficiaries? Since the first successful use of a permanent single chamber cardiac pacemaker in 1960 resulted in a post-implant survival of 18 months for a patient with complete heart block Chardack, 1960; Beck, 2010 , various studies and reviews Edhag, 1976; Hansen, 1974; Müller, 1988; Rosenqvist, 1992 have supported the improvements in health outcomes from implantation and use of single chamber pacemakers. Hansen and Meibom 1974 reported one year survival of 87 percent for patients with complete heart block treated with permanent pacemakers compared to 50 percent for similar patients without pacemakers Johansson, 1969. Over the past five decades, as medical knowledge and technology have advanced, the cardiac pacemaker has evolved from a bulky single lead device to a category of sophisticated devices with one or more leads capable of administering complex pacing programs and auto-monitoring. Greenspon 2012 noted the rapid uptake and utilization of these advanced devices in place of the single lead pacemaker, which is historically the recognized standard for symptomatic bradycardia. With the changes in the past decades, CMS has conducted this analysis to update the coverage decision from the early 1980s. Ideally there should be robust evidence on benefits of new technology prior to widespread adoption, to support clinically important advancements in the health of the population. For symptomatic bradycardia, five randomized controlled trials CTOPP, DANPACE, MOST, PASE, UKPACE , two systematic evidence reviews Cochrane and UK HTA and evidence-based guidelines from professional societies were included in our analysis for the health outcome of all-cause mortality primary outcome in DANPACE and UKPACE; pre-specified secondary outcome in CTOPP, PASE, and MOST. None of the trials demonstrated significant differences in all-cause mortality between dual chamber pacemakers and single chamber pacemakers. In other words, the mortality rate in patients receiving dual chamber pacemakers was comparable to the rate in patients who received single chamber pacemakers for symptomatic bradycardia due to SND or AV conduction blocks. There were also no reported significant differences in stroke or cardiovascular death. While the Cochrane review was published in 2004 and did not include two trials DANPACE, UKPACE , the findings were consistent with our review. The UK HTA appraisal 2005 , which did not include DANPACE and the final published results of UKPACE, also found no significant effect on mortality. Although there are no suggestions that the reviews will be revised, it seems unlikely that the inclusion of the results of these two trials would markedly alter the conclusions of the Cochrane review and UK HTA appraisal given the reported findings of DANPACE and UKPACE. While there is no reported difference in mortality between single chamber and dual chamber cardiac pacemakers, there is some indication of better secondary outcomes from use of dual chamber pacemakers, including reduction in occurrence of AF and improved quality of life. For AF, two trials CTOPP, MOST found small but significant absolute reductions in rate of AF in patients receiving dual chamber pacemakers compared to single chamber. Toff UKPACE did not find any significant difference in AF. Quality of life was a primary outcome in one study PASE and a secondary outcome in another MOST. Lamas PASE reported that health related quality of life improved with permanent pacemaker implantation but there was no significant difference between single and dual chamber pacemakers. Quality of life is an important patient-centered outcome but measurement of this outcome may be subject to participant and recall bias. Periprocedural complications usually within 30 days of implantation were specifically reported in two trials CTOPP, UKPACE and were significantly higher for dual chamber pacemakers compared to single chamber pacemakers. Based on our review of the published evidence of these trial results, health outcomes are comparable for patients who receive dual chamber pacemakers compared to those who receive single chamber pacemakers for symptomatic bradycardia but the choice of device may be influenced by the reduced rate of AF and higher perioperative complications seen with implantation of dual chamber pacemakers. The trial populations were representative of the Medicare population on age, comorbidities and indications for cardiac pacing so generalizability is acceptable. Since historically the implantation and use of single chamber pacemakers have resulted in improved survival, these devices are generally considered the gold standard for patients with symptomatic bradycardia. Dual chamber pacemakers may be considered alternatives for individuals who may benefit from more complex pacing. Shared decision making between the physician and patient remains important for device choice on an individual basis. We expect that physicians will carefully document the need for dual chamber pacemakers in the medical record, and that patients will be informed of the potentially higher complication rates following implantation of dual chamber devices as reported in the randomized controlled trials. The use of evidence-based guidelines and expert consensus statements may also help to inform the device selection process. Based on our review of the published evidence, we did not find specific evidence to support making many modifications to the list of specific non-covered indications identified in section 20. Due to changes to the covered indications, however, we are revising the descriptions of the non-covered indications for clarity and to ensure there is internal consistency with covered indications. We are specifically non-covering permanent implantable single chamber or dual chamber cardiac pacemakers for patients with reversible causes of bradycardia such as electrolyte abnormalities, medications or drugs, or hypothermia , since reversible causes of bradycardia are transient and not permanent in nature. We are non-covering permanent implantable single chamber or dual chamber cardiac pacemakers for patients with asymptomatic first degree AVB. While pacemaker longevity has increased over the past few decades, replacement of a permanent cardiac pacemaker is occasionally needed due to wear or damage to one or more components battery, generator, or leads. We did not find any specific evidence or recommendations on how to replace these devices or on which replacement devices should be used. Given the nature of the reasons for replacements, prudent clinical judgment should be used on an individual basis, along with documentation in the medical record on the initial indication for the pacemaker, the reason for replacement, and the justification of the type of replacement device selected. In rare instances, historical medical records may not be immediately available; however, adequate documentation should still be maintained to explain the existing circumstances and situation. Disparities Gender differences have been reported for various cardiac interventions Jacobs, 2003 and implanted devices Curtis, 2007. If gender differences are detected, then modifications may be considered. Summary There is an established and accepted association between single chamber cardiac pacemaker use, survival, and improvement in health outcomes. Historically, the use of single chamber pacemakers has been shown to improve survival for treatment of symptomatic bradycardia. Studies have demonstrated that health outcomes are similar for individuals that receive dual chamber pacemakers compared with single chamber pacemakers for treatment of symptomatic bradycardia. A dual chamber pacemaker may be considered as an alternative for individuals who may benefit from more complex pacing. There is some indication of better secondary outcomes from the use of dual chamber pacemakers, including reduction in occurrence of atrial fibrillation and improved quality of life. The choice of device may be influenced by reduced occurrence of AF and higher perioperative complications seen with dual chamber pacemakers, emphasizing the importance of informed, shared decision making between the physician and patient. Therefore, we have determined that permanent implantable single chamber and dual chamber cardiac pacemakers are reasonable and necessary subject to the conditions described in our conclusion below. Symptoms of bradycardia are symptoms that can be directly attributable to a heart rate less than 60 beats per minute for example: syncope, seizures, congestive heart failure, dizziness, or confusion. Medicare Administrative Contractors will determine coverage under section 1862 a 1 A of the Social Security Act for any other indications for the implantation and use of single chamber or dual chamber cardiac pacemakers that are not specifically addressed in this national coverage determination. Appendix A General Methodological Principles of Study Design When making national coverage determinations, CMS evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service falling within a benefit category is reasonable and necessary for the diagnosis or treatment of an illness or injury or to improve the functioning of a malformed body member. The overall objective for the critical appraisal of the evidence is to determine to what degree we are confident that: 1 the specific assessment questions can be answered conclusively; and 2 the intervention will improve health outcomes for patients. The methodological principles described below represent a broad discussion of the issues we consider when reviewing clinical evidence. However, it should be noted that each coverage determination has its unique methodological aspects. Assessing Individual Studies Methodologists have developed criteria to determine weaknesses and strengths of clinical research. Strength of evidence generally refers to: 1 the scientific validity underlying study findings regarding causal relationships between health care interventions and health outcomes; and 2 the reduction of bias. In general, some of the methodological attributes associated with stronger evidence include those listed below. Sample size should be large enough to make chance an unlikely explanation for what was found. Use masking blinding to ensure patients and investigators do not know to which group patients were assigned intervention or control. This is important especially in subjective outcomes, such as pain or quality of life, where enthusiasm and psychological factors may lead to an improved perceived outcome by either the patient or assessor. Regardless of whether the design of a study is a randomized controlled trial, a non-randomized controlled trial, a cohort study or a case-control study, the primary criterion for methodological strength or quality is the extent to which differences between intervention and control groups can be attributed to the intervention studied. This is known as internal validity. Various types of bias can undermine internal validity. In principle, rankings of research design have been based on the ability of each study design category to minimize these biases. A randomized controlled trial minimizes systematic bias in theory by selecting a sample of participants from a particular population and allocating them randomly to the intervention and control groups. Thus, in general, randomized controlled studies have been typically assigned the greatest strength, followed by non-RCTs and controlled observational studies. The design, conduct and analysis of trials are important factors as well. For example, a well designed and conducted observational study with a large sample size may provide stronger evidence than a poorly designed and conducted randomized controlled trial with a small sample size. The following is a representative list of study designs some of which have alternative names ranked from most to least methodologically rigorous in their potential ability to minimize systematic bias. Confounding refers to independent variables that systematically vary with the causal variable. This distorts measurement of the outcome of interest because its effect size is mixed with the effects of other extraneous factors. For observational, and in some cases randomized controlled trials, the method in which confounding factors are handled either through stratification or appropriate statistical modeling are of particular concern. For example, in order to interpret and generalize conclusions to our population of Medicare patients, it may be necessary for studies to match or stratify their intervention and control groups by patient age or co-morbidities. Methodological strength is, therefore, a multidimensional concept that relates to the design, implementation and analysis of a clinical study. In addition, thorough documentation of the conduct of the research, particularly study selection criteria, rate of attrition and process for data collection, is essential for CMS to adequately assess and consider the evidence. Generalizability of Clinical Evidence to the Medicare Population The applicability of the results of a study to other populations, settings, treatment regimens and outcomes assessed is known as external validity. Even well-designed and well-conducted trials may not supply the evidence needed if the results of a study are not applicable to the Medicare population. Evidence that provides accurate information about a population or setting not well represented in the Medicare program would be considered but would suffer from limited generalizability. The extent to which the results of a trial are applicable to other circumstances is often a matter of judgment that depends on specific study characteristics, primarily the patient population studied age, sex, severity of disease and presence of co-morbidities and the care setting primary to tertiary level of care, as well as the experience and specialization of the care provider. Additional relevant variables are treatment regimens dosage, timing and route of administration , co-interventions or concomitant therapies, and type of outcome and length of follow-up. Trial participants in an academic medical center may receive more or different attention than is typically available in non-tertiary settings. Conditions that assist us in making reasonable generalizations are biologic plausibility, similarities between the populations studied and Medicare patients age, sex, ethnicity and clinical presentation and similarities of the intervention studied to those that would be routinely available in community practice. One of the goals of our determination process is to assess health outcomes. We are interested in the results of changed patient management not just altered management. These outcomes include resultant risks and benefits such as increased or decreased morbidity and mortality. In order to make this determination, it is often necessary to evaluate whether the strength of the evidence is adequate to draw conclusions about the direction and magnitude of each individual outcome relevant to the intervention under study. Generally, an intervention is not reasonable and necessary if its risks outweigh its benefits. If key health outcomes have not been studied or the direction of clinical effect is inconclusive, we may also evaluate the strength and adequacy of indirect evidence linking intermediate or surrogate outcomes to our outcomes of interest. Assessing the Relative Magnitude of Risks and Benefits Generally, an intervention is not reasonable and necessary if its risks outweigh its benefits. Health outcomes are one of several considerations in determining whether an item or service is reasonable and necessary. For most determinations, CMS evaluates whether reported benefits translate into improved health outcomes. CMS places greater emphasis on health outcomes actually experienced by patients, such as quality of life, functional status, duration of disability, morbidity and mortality, and less emphasis on outcomes that patients do not directly experience, such as intermediate outcomes, surrogate outcomes, and laboratory or radiographic responses. The direction, magnitude and consistency of the risks and benefits across studies are also important considerations. DDD pacing: an effective treatment modality for recurrent atrial arrhythmias. Dhingra RC, Denes P, Wu D, Chuquimia R and Rosen KM. The significance of second degree atrioventricular block and bundle branch block. Observations regarding site and type of block. Gammage M, Schofield S, Rankin I, Bennett M, Coles P and Pentecost B. Benefit of single setting rate responsive ventricular pacing compared with fixed rate demand pacing in elderly patients. Kay R, Estioko M and Wiener I. Primary sick sinus syndrome as an indication for chronic pacemaker therapy in young adults: incidence, clinical features, and long-term evaluation. Ouali S, Neffeti E, Ghoul K, et al. DDD versus VVIR pacing in patients, ages 70 and over, with complete heart block. Shohat-Zabarski R, Iakobishvili Z, Kusniec J, Mazur A and Strasberg B. Paroxysmal atrioventricular block: clinical experience with 20 patients. Steinbach M, Douchet MP, Bakouboula B, Bronner F and Chauvin M. Outcome of patients aged over 75 years who received a pacemaker to treat sinus node dysfunction. Cardiac resynchronization in chronic heart failure. N Engl J Med. Albertsen AE, Nielsen JC, Poulsen SH, et al. Biventricular pacing preserves left ventricular performance in patients with high-grade atrio-ventricular block: a randomized comparison with DDD R pacing in 50 consecutive patients. Barold SS, Wyndham CR, Kappenberger LL, Abinader EG, Griffin JC and Falkoff MD. Implanted atrial pacemakers for paroxysmal atrial flutter. Elkayam LU, Koehler JL, Sheldon TJ, Glotzer TV, Rosenthal LS and Lamas GA. The Influence of Atrial and Ventricular Pacing on the Incidence of Atrial Fibrillation: A Meta-Analysis. Fananapazir L, Cannon RO, 3rd, Tripodi D and Panza JA. Impact of dual-chamber permanent pacing in patients with obstructive hypertrophic cardiomyopathy with symptoms refractory to verapamil and beta-adrenergic blocker therapy. Fisher JD, Johnston DR, Furman S, Mercando AD and Kim SG. Long-term efficacy of antitachycardia pacing for supraventricular and ventricular tachycardias. Galve E, Sambola A, Saldana G, et al. Late benefits of dual-chamber pacing in obstructive hypertrophic cardiomyopathy: a 10-year follow-up study. Gillis AM, Koehler J, Morck M, Mehra R and Hettrick DA. High atrial antitachycardia pacing therapy efficacy is associated with a reduction in atrial tachyarrhythmia burden in a subset of patients with sinus node dysfunction and paroxysmal atrial fibrillation. Herre JM, Griffin JC, Nielsen AP, et al. Permanent triggered antitachycardia pacemakers in the management of recurrent sustained ventricular tachycardia. J Am Coll Cardiol. Jeanrenaud X, Goy JJ and Kappenberger L. Effects of dual-chamber pacing in hypertrophic obstructive cardiomyopathy. Kappenberger L, Linde C, Daubert C, et al. Pacing in hypertrophic obstructive cardiomyopathy. A randomized crossover study. Kass DA, Chen CH, Curry C, et al. Improved left ventricular mechanics from acute VDD pacing in patients with dilated cardiomyopathy and ventricular conduction delay. Leclercq C, Cazeau S, Lellouche D, et al. Upgrading from single chamber right ventricular to biventricular pacing in permanently paced patients with worsening heart failure: The RD-CHF Study. Lee MA, Weachter R, Pollak S, et al. The effect of atrial pacing therapies on atrial tachyarrhythmia burden and frequency: results of a randomized trial in patients with bradycardia and atrial tachyarrhythmias. J Am Coll Cardiol. Maron BJ, Nishimura RA, McKenna WJ, Rakowski H, Josephson ME and Kieval RS. Assessment of permanent dual-chamber pacing as a treatment for drug-refractory symptomatic patients with obstructive hypertrophic cardiomyopathy. A randomized, double-blind, crossover study M-PATHY. Nishimura RA, Trusty JM, Hayes DL, et al. Dual-chamber pacing for hypertrophic cardiomyopathy: a randomized, double-blind, crossover trial. J Am Coll Cardiol. Saad EB, Marrouche NF, Martin DO, et al. Frequency and associations of symptomatic deterioration after dual-chamber defibrillator implantation in patients with ischemic or idiopathic dilated cardiomyopathy. Steinberg JS, Fischer A, Wang P, et al. The clinical implications of cumulative right ventricular pacing in the multicenter automatic defibrillator trial II. Sweeney MO, Hellkamp AS, Ellenbogen KA, et al. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Thambo JB, Bordachar P, Garrigue S, et al. Detrimental ventricular remodeling in patients with congenital complete heart block and chronic right ventricular apical pacing. Vanderheyden M, Goethals M, Anguera I, et al. Hemodynamic deterioration following radiofrequency ablation of the atrioventricular conduction system. Wilkoff BL, Cook JR, Epstein AE, et al. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator DAVID Trial. Zeltser D, Justo D, Halkin A, et al. Drug-induced atrioventricular block: prognosis after discontinuation of the culprit drug. J Am Coll Cardiol. DDD R -pacing, but not AAI R -pacing induces left ventricular desynchronization in patients with sick sinus syndrome: tissue-Doppler and 3D echocardiographic evaluation in a randomized controlled comparison. Brecker SJ, Xiao HB, Sparrow J and Gibson DG. Effects of dual-chamber pacing with short atrioventricular delay in dilated cardiomyopathy. Choo WK and Gupta S. The impact of NICE UK recommendations on outcomes of cardiac pacemaker implantations - a single-centre, district hospital experience. J Eval Clin Pract. Dorenkamp M, Breitwieser C, Morguet AJ, Seegers J, Behrens S and Zabel M. T-wave alternans testing in pacemaker patients: comparison of pacing modes and long-term prognostic relevance. Kafkas N, Patsilinakos S, Makris K, et al. Brain natriuretic peptide: a marker of cardiac dysfunction with ventricular or dual-chamber pacing. Knight BP, Gersh BJ, Carlson MD, et al. Role of permanent pacing to prevent atrial fibrillation: science advisory from the American Heart Association Council on Clinical Cardiology Subcommittee on Electrocardiography and Arrhythmias and the Quality of Care and Outcomes Research Interdisciplinary Working Group, in collaboration with the Heart Rhythm Society. Kristensen L, Nielsen JC, Mortensen PT, Pedersen AK and Andersen HR. Evaluation of pacemaker telemetry as a diagnostic feature for detecting atrial tachyarrhythmias in patients with sick sinus syndrome. Lelakowski J, Majewski J, Malecka B, Bednarek J, Stypula P and Szeglowski M. Retrospective analysis of reasons for failure of DDD pacemaker implantation in patients operated on between 1993 and 2005. Linde-Edelstam C, Nordlander R, Pehrsson SK and Ryden L. A double-blind study of submaximal exercise tolerance and variation in paced rate in atrial synchronous compared to activity sensor modulated ventricular pacing. Maurer G, Torres MA, Corday E, Haendchen RV and Meerbaum S. Two-dimensional echocardiographic contrast assessment of pacing-induced mitral regurgitation: relation to altered regional left ventricular function. J Am Coll Cardiol. Nahlawi M, Waligora M, Spies SM, Bonow RO, Kadish AH and Goldberger JJ. Left ventricular function during and after right ventricular pacing. J Am Coll Cardiol. Nery PB, Fernandes R, Nair GM, et al. Device-related infection among patients with pacemakers and implantable defibrillators: incidence, risk factors, and consequences. Quirino G, Giammaria M, Corbucci G, et al. Diagnosis of paroxysmal atrial fibrillation in patients with implanted pacemakers: relationship to symptoms and other variables. Rubaj A, Rucinski P, Sodolski T, et al. Comparison of the acute hemodynamic effect of right ventricular apex, outflow tract, and dual-site right ventricular pacing. Sutton R and Bourgeois I. Cost benefit analysis of single and dual chamber pacing for sick sinus syndrome and atrioventricular block. An economic sensitivity analysis of the literature. Search Time Andersen HR, Nielsen JC, Thomsen PE, et al. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. Kusumoto FM and Goldschlager N. N Engl J Med. Mymin D, Mathewson FA, Tate RB and Manfreda J. The natural history of primary first-degree atrioventricular heart block. N Engl J Med. Chronic sinus node disease: natural course and indications for pacing. Strasberg B, Amat YLF, Dhingra RC, et al. Natural history of chronic second-degree atrioventricular nodal block. Pacing Site, Device Programming Carlson MD, Ip J, Messenger J, et al. A new pacemaker algorithm for the treatment of atrial fibrillation: results of the Atrial Dynamic Overdrive Pacing Trial ADOPT. J Am Coll Cardiol. Gillis AM, Purerfellner H, Israel CW, et al. Reducing unnecessary right ventricular pacing with the managed ventricular pacing mode in patients with sinus node disease and AV block. Heldman D, Mulvihill D, Nguyen H, et al. True incidence of pacemaker syndrome. Hermida JS, Kubala M, Lescure FX, et al. Atrial septal pacing to prevent atrial fibrillation in patients with sinus node dysfunction: results of a randomized controlled study. Israel CW, Hugl B, Unterberg C, et al. Pace-termination and pacing for prevention of atrial tachyarrhythmias: results from a multicenter study with an implantable device for atrial therapy. Lamas GA, Knight JD, Sweeney MO, et al. Impact of rate-modulated pacing on quality of life and exercise capacity evidence from the Advanced Elements of Pacing Randomized Controlled Trial ADEPT. Madan N and Saksena S. Nguyen CT, Moreno-Cabral CE and Mahnke CB. Pacemaker upgrade causing new-onset heart failure in a patient with complete congenital atrioventricular block. Nielsen JC, Pedersen AK, Mortensen PT and Andersen HR. Programming a fixed long atrioventricular delay is not effective in preventing ventricular pacing in patients with sick sinus syndrome. Nikoo MH, Ghaedian MM, Kafi M, et al. Effects of right ventricular septal versus apical pacing on plasma natriuretic peptide levels. J Cardiovasc Dis Res. Nitardy A, Langreck H, Dietz R and Stockburger M. Reduction of right ventricular pacing in patients with sinus node dysfunction through programming a long atrioventricular delay along with the DDIR mode. Olshansky B, Day JD, Moore S, et al. Is dual-chamber programming inferior to single-chamber programming in an implantable cardioverter-defibrillator? Results of the INTRINSIC RV Inhibition of Unnecessary RV Pacing With AVSH in ICDs study. Saksena S, Prakash A, Hill M, et al. Prevention of recurrent atrial fibrillation with chronic dual-site right atrial pacing. J Am Coll Cardiol. Sanfins V, Alves A, Rodrigues B, et al. RIVER: Portuguese registry to monitor unnecessary right ventricular pacing. Sharma AD, Rizo-Patron C, Hallstrom AP, et al. Percent right ventricular pacing predicts outcomes in the DAVID trial. Sulke N, Chambers J, Dritsas A and Sowton E. A randomized double-blind crossover comparison of four rate-responsive pacing modes. J Am Coll Cardiol. Sweeney MO, Bank AJ, Nsah E, et al. Minimizing ventricular pacing to reduce atrial fibrillation in sinus-node disease. N Engl J Med. Sweeney MO, Ellenbogen KA, Miller EH, Sherfesee L, Sheldon T and Whellan D. The Managed Ventricular pacing versus VVI 40 Pacing MVP Trial: clinical background, rationale, design, and implementation. Sweeney MO, Hellkamp AS, Ellenbogen KA, et al. Prospective randomized study of mode switching in a clinical trial of pacemaker therapy for sinus node dysfunction. Tops LF, Schalij MJ and Bax JJ. The effects of right ventricular apical pacing on ventricular function and dyssynchrony implications for therapy. J Am Coll Cardiol. Veasey RA, Arya A, Silberbauer J, Sharma V, Lloyd GW, Patel NR, Sulke AN. The relationship between right ventricular pacing and atrial fibrillation burden and disease progression in patients with paroxysmal atrial fibrillation: the long-MinVPACE study. Epub 2011 Jan 5. Editorials, Commentaries Connelly DT and Steinhaus DM. Mobitz type I atrioventricular block: an indication for permanent pacing? Das MK, Dandamudi G and Steiner HA. Modern pacemakers: hope or hype? Atrial pacing, the forgotten pacing mode. Abstract Modi S, Krahn A and Yee R. Current concepts in pacing 2010-2011: the right and wrong way to pace. Curr Treat Options Cardiovasc Med. Appendix D ECG Grid: Waves, Intervals, and Segments Clinical Methods: The History, Physical, and Laboratory Examinations. Walker HK, Hall WD, Hurst JW, editors. Copyright © 1990, Butterworth Publishers, a division of Reed Publishing. A service of the National Library of Medicine, National Institutes of Health. Recommendations for pacemaker prescription for symptomatic bradycardia. Report of a working party of the British Pacing and Electrophysiology Group. Bernstein AD, Daubert JC, Fletcher RD, Hayes DL, Lüderitz B, Reynolds DW, Schoenfeld MH, Sutton R. J of Pacing and Clinical Electrophysiology. Developed in partnership between the Heart Rhythm Society HRS and the American College of Cardiology Foundation ACCF and in collaboration with the Society of Thoracic Surgeons. Andersen HR, Nielsen JC, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. Beck H, Boden WE, Patibandla S, Kireyev D, Gupta V, Campagna F, Cain ME, Marine JE. Bernstein AD, Camm AJ, Fletcher RD, Gold RD, Rickards AF, Smyth NP, Spielman SR, Sutton R. Bernstein AD, Daubert JC, Fletcher RD, Hayes DL, Lüderitz B, Reynolds DW, Schoenfeld MH, Sutton R. J of Pacing and Clinical Electrophysiology. Bernstein AD, Parsonnet V. Survey of cardiac pacing and implanted defibrillator practice patterns in the United States in 1997. Castelnuovo E, Stein K, Pitt M, Garside R, Payne E. The effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber pacemakers for bradycardia due to atrioventricular block or sick sinus syndrome: systematic review and economic evaluation. Health Technol Assess 2005;9 43. Chardack WM, Gage AA, Greatbatch W. A transistorized, self-contained, implantable pacemaker for the long-term correction of complete heart block. Connolly SJ, Kerr CR, Gent M, Roberts RS, Yusuf S, Gillis AM, Sami MH, Talajic M, Tang AS, Klein GJ, Lau C, Newman DM. Effects of physiologic pacing versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. Canadian Trial of Physiologic Pacing Investigators. N Engl J Med. Curtis LH, Al-khatib SM, Shea AM, Hammill BG, Hernandez AF, Schulman KA. Sex differences in the use of implantable cardioverter-defibrillators for primary and secondary prevention of sudden cardiac death. Daugherty SL, Peterson PN, Wang Y, Curtis JP, Heidenreich PA, Lindenfeld J, Vidaillet HJ, Masoudi FA; NCDR. Use of implantable cardioverter defibrillators for primary prevention in the community; do women and men equally meet trial enrollment criteria? Dretzke J, Toff WD, Lip GYH, Raftery J, Fry-Smith A, Taylor RRS. Dual chamber versus single chamber ventricular pacemakers for sick sinus syndrome and atrioventricular block. Cochrane Database of Systematic Reviews 2004, Issue 2. Edhag O, Swahn A. Prognosis of patients with complete heart block or arrhythmic syncope who were not treated with artificial pacemakers. A long-term follow-up study of 101 patients. The pacemaker syndrome a matter of definition. Epstein AE, Dimarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Society of Thoracic Surgeons. Epub 2008 May 21. Fleischmann KE, Orav EJ, Lamas GA, Mangione CM, Schron E, Lee KL, Goldman L. Pacemaker implantation and quality of life in the Mode Selection Trial MOST. Epub 2006 Mar 13. Fored CM, Granath F, Gadler F, Blomqvist P, Rynder J, Linde C, Ekbom A, Rosenqvist M. Epub 2008 May 7. Gillis AM, Russo AM, Ellenbogen KA, Swerdlow CD, Olshansky B, Al-Khatib SM, Beshai JF, McComb JM, Nielsen JC, Philpott JM, Shen WK; Heart Rhythm Society; American College of Cardiology Foundation. Developed in partnership between the Heart Rhythm Society HRS and the American College of Cardiology Foundation ACCF and in collaboration with the Society of Thoracic Surgeons. Ginter JF, Loftis P. J of the Am Academy of Physician Assistants. Greenspon AJ, Patel JD, Lau E, Ochoa JA, Frisch DR, Ho RT, Pavri BB, Kurtz SM. Trends in permanent pacemaker implantation in the United States from 1993 to 2009: increasing complexity of patients and procedures. J Am Coll Cardiol. Epub 2012 Sep 19. Grenouilleau-Albertini A, Copie X, Mabo P, et al. Single or dual-chamber pacemakers? The guidelines of the HAS. Archives of Cardiovascular Diseases Supplements. Hansen JF, Meibom J. The prognosis for patients with complete heart block treated with permanent pacemaker. Healey JS, Toff WD, Lamas GA, Andersen HR, Thorpe KE, Ellenbogen KA, Lee KL, Skene AM, Schron EB, Skehan JD, Goldman L, Roberts RS, Camm AJ, Yusuf S, Connolly SJ. Cardiovascular outcomes with atrial-based pacing compared with ventricular pacing: meta-analysis of randomized trials, using individual patient data. Epub 2006 Jun 26. Br Med J Clin Res Ed. Longevity in complete heart block. Ann NY Acad Sci. Kaszala K, Kalahasty G, Ellenbogen KA. Cardiac pacing in the elderly. Am J Geriatr Cardiol. Kerr CR, Connolly SJ, Abdollah H, Roberts RS, Gent M, Yusuf S, Gillis AM, Tang AS, Talajic M, Klein GJ, Newman DM. Canadian Trial of Physiological Pacing: Effects of physiological pacing during long-term follow-up. Epub 2004 Jan 5. Lamas GA, Lee K, Sweeney M, Leon A, Yee R, Ellenbogen K, Greer S, Wilber D, Silverman R, Marinchak R, Bernstein R, Mittleman RS, Lieberman EH, Sullivan C, Zorn L, Flaker G, Schron E, Orav EJ, Goldman L. The Mode Selection Trial MOST in sinus node dysfunction: design, rationale, and baseline characteristics of the first 1000 patients. Lamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, Flaker G, Schron E, Orav EJ, Hellkamp AS, Greer S, McAnulty J, Ellenbogen K, Ehlert F, Freedman RA, Estes NA 3 rd, Greenspon A, Goldman L; Mode Selection Trial in Sinus-Node Dysfunction. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. Lamas GA, Orav EJ, Stambler BS, Ellenbogen KA, Sgarbossa EB, Huang SK, Marinchak RA, Estes NA 3rd, Mitchell GF, Lieberman EH, Mangione CM, Goldman L. Quality of life and clinical outcomes in elderly patients treated with ventricular pacing as compared with dual-chamber pacing. Pacemaker Selection in the Elderly Investigators. N Engl J Med. Mangrum JM, DiMarco JP. The evaluation and management of bradycardia. N Engl J Med. Modi S, Krahn A, Yee R. Current concepts in pacing 2010-2011: the right and wrong way to pace. Curr Treat Options Cardiovasc Med. Müller C, Cernin J, Glogar D, Laczkovics A, Mayr H, Scheibelhofer W, Schmidinger H, Schuster E, Sedlacek K, Kaliman J. Survival rate and cause of death in patients with pacemakers: dependence on symptoms leading to pacemaker implantation. Nielsen JC, Kristensen L, Andersen HR, Mortensen PT, Pedersen OL, Pedersen AK. A randomized comparison of atrial and dual-chamber pacing in 177 consecutive patients with sick sinus syndrome: echocardiographic and clinical outcome. J Am Coll Cardiol. Nielsen JC, Thomsen PE, Højberg S, Møller M, Vesterlund T, Dalsgaard D, Mortensen LS, Nielsen T, Asklund M, Friis EV, Christensen PD, Simonsen EH, Eriksen UH, Jensen GV, Svendsen JH, Toff WD, Healey JS, Andersen HR; DANPACE Investigators. A comparison of single-lead atrial pacing with dual-chamber pacing in sick sinus syndrome. Epub 2011 Feb 7. Nowak B, Misselwitz B, Erdogan A, et al. Do gender differences exist in pacemaker implantation? Rosenqvist M, Nordlander R. Survival in patients with permanent pacemakers. Silberbauer J, Veasey RA, Freemantle N, Arya A, Boodhoo L, Sulke N. The relationship between high-frequency right ventricular pacing and paroxysmal atrial fibrillation burden. Epub 2009 Aug 6. Toff WD, Camm AJ, Skehan JD; United Kingdom Pacing and Cardiovascular Events Trial Investigators. Single-chamber versus dual-chamber pacing for high-grade atrioventricular block. N Engl J Med. Vardas PE, Auricchio A, Blanc JJ, Daubert JC, Drexler H, Ector H, Gasparini M, Linde C, Morgado FB, Oto A, Sutton R, Trusz-Gluza M; European Society of Cardiology; European Heart Rhythm Association. Guidelines for cardiac pacing and cardiac resynchronization therapy: The Task Force for Cardiac Pacing and Cardiac Resynchronization Therapy of the European Society of Cardiology. Developed in collaboration with the European Heart Rhythm Association. Epub 2007 Aug 28. Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Michel MC, Dalquist JE, Corley SD; Atrial Fibrillation Follow-up Investigation of Rhythm Management AFFIRM Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med. Zhan C, Baine WB, Sedrakyan A, Steiner C. Cardiac device implantation in the United States from 1997 through 2004: a population-based analysis. J Gen Intern Med.
Epub 2008 May 21. The recall may be as simple as a physical exam and some quick tests on the device. This is known as internal validity. One option that might be recommended, particularly if you have also known as tachycardia-bradycardia syndromeis a limbo. Primary outcome was death from any cause or nonfatal stroke. Müller C, Cernin J, Glogar D, Laczkovics A, Mayr H, Scheibelhofer W, Schmidinger H, Schuster E, Sedlacek K, Kaliman J. An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate met by the patient. Typically, two or three small, flexible wires are placed in inside the heart. Greenspon 2012 noted the rapid uptake and utilization of these advanced devices in place of the single lead pacemaker, which is historically the recognized standard for symptomatic bradycardia. Together you can take elements and ask all of your questions. Studies have demonstrated that health outcomes are similar for individuals that receive dual chamber pacemakers compared with single chamber pacemakers for treatment of symptomatic bradycardia. Mean age at baseline was 73 years.

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