Managing with pacemakers and implantable cardioverter defibrillators

May combine two claims.

In a contemporary real-world ICD population, appropriate shocks occur in approximately 6% per year of ICD patients, and inappropriate shocks occur in approximately 8% per year.

“In a contemporary real-world ICD population, appropriate shocks occur in ≈6% per year of ICD patients, and inappropriate shocks occur in ≈8% per year.24”

• cites [24] 24. Saxon LA, Hayes DL, Gilliam FR, Heidenreich PA, Day J, Seth M, Meyer TE, Jones PW, Boehmer JP. Long-term outcome after ICD and CRT implantation and influence of remote device follow-up: the ALTITUDE survival study. Circulation. 2010;122:2359-2367. sourceDisputed

  The section “Shock Therapies and Programming in Patients Followed Up on the Network” reports the one-year figures in the opposite order: 8% appropriate shocks and 6% inappropriate shocks. The citing sentence reverses those rates. (LLM, conf=0.95)

  Checked by a reasoning model — may be wrong.

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

The importance of psychoeducational interventions reported to date to improve quality of life and mood disturbances in ICD patients has been recently reviewed.

“The importance of psychoeducational interventions, 15 reported to date, to improve QOL and mood disturbances in ICD patients has been recently reviewed.7”

• cites [15] 15. Pedersen SS, Van Den Broek KC, Van Den Berg M, Theuns DA. Shock as a determinant of poor patient-centered outcomes in implantable cardio- verter defibrillator patients: is there more to it than meets the eye? Pacing Clin Electrophysiol. 2010;33:1430-1436. sourceNot checked — no full text of the source
• cites [7] 7. Dunbar SB, Dougherty CM, Sears SF, Carroll DL, Goldstein NE, Mark DB, McDaniel G, Pressler SJ, Schron E, Wang P, Zeigler VL. Educational and psychological interventions to improve outcomes for recipients of implantable cardioverter defibrillators and their families Circulation.2012;126:2146-2172. sourceSupported

May combine two claims.

In the AVID trial, baseline quality of life measured by SF-36 in ICD patients was similar to that of elderly patients with recent myocardial infarction or severe heart failure, but less than for ambulatory patients with heart failure.

“In the Antiarrhythmics Versus Implanted Defibrillators (AVID) trial, baseline QOL measured by SF-36 in ICD patients was similar to that of elderly patients with recent myocardial infarction or severe heart failure, but less than for ambulatory patients with heart failure”

• cites [5] 5. Schron E, Exner D, Yao Q, Jenkins L, Steinberg J, Cook J, Kutalek S, Friedman P, Bubien R, Page R, Powell J. Quality of life in the Antiarrhythmics versus Implantable Defibrillators trial. Circulation. 2002;105:589-594 sourceSupported

May combine two claims.

Most psychoeducational interventions have included in-person or telephone interventions with cognitive behavioral therapy frameworks, which have shown improvements in anxiety, depression, and posttraumatic stress disorder, although sample sizes have been small.

“Most have included in-person or telephone interventions with the use of cognitive behavioral therapy frameworks, which have shown improvements in anxiety, depression, and posttraumatic stress disorder, although sample sizes have been small.”

• cites [7] 7. Dunbar SB, Dougherty CM, Sears SF, Carroll DL, Goldstein NE, Mark DB, McDaniel G, Pressler SJ, Schron E, Wang P, Zeigler VL. Educational and psychological interventions to improve outcomes for recipients of implantable cardioverter defibrillators and their families Circulation.2012;126:2146-2172. sourceSupported

May combine two claims.

In studies, from 7.5% of primary prevention patients to 48% of those with a history of ventricular arrhythmia received a shock for any reason in a year.

“In studies, from 7.5% of primary prevention patients 22 to 48% of those with a history of ventricular arrhythmia 23 received a shock for any reason in a year.”

• cites [22] 22. Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352:225-237. sourceSupported
• cites [23] 23. Pacifico A, Hohnloser S, Williams J, Tao B, Saksena S, Henry P, Prystowsky E. Prevention of implantable-defibrillator shocks by treatment with sotalol. N Eng J Med. 1999;340:1855-1862 sourceNot checked — no full text of the source

May combine two claims.

Surveys reveal that patients prefer home to in-office monitoring, and physicians find that the systems are user friendly.

“In general, surveys reveal that patients prefer home to in-office monitoring, and physicians find that the systems are user friendly.52,53”

• cites [52] 52. Raatikainen MJ, Uusimaa P, van Ginneken MM, Janssen JP, Linnaluoto M. Remote monitoring of implantable cardioverter defibrillator patients: a safe, time-saving, and cost-effective means for follow-up. Europace. 2008;10:1145-1151. sourcePartly supported

  The Results section ('Ease of use and satisfaction'; page unavailable) reports that physicians found website access easy or very easy for 97% of transmissions and navigation very easy. The Methods section says patients were asked whether they preferred remote monitoring or in-office visits, but the available Results passage does not report which they preferred. This source therefore supports the physician-usability claim, not the claimed patient preference. (LLM, conf=0.87)

  Experimental — accuracy not yet measured
• cites [53] 53. Marzegalli M, Lunati M, Landolina M, Perego GB, Ricci RP, Guenzati G, Schirru M, Belvito C, Brambilla R, Masella C, Di Stasi F, Valsecchi S, Santini M. Remote monitoring of CRT-ICD: the multicenter Italian CareLink evaluation-ease of use, acceptance, and organizational implica- tions. Pacing Clin Electrophysiol. 2008;31:1259-1264. sourceNot checked — no full text of the source

May combine two claims.

In the COMPAS trial, both ambulatory visits and hospitalizations were fewer in those randomly assigned to remote follow-up.

“In the similar, more recent Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure (COMPAS) trial, both ambulatory visits and hospitalizations were fewer in those randomly assigned to remote follow-up.58”

• cites [58] 58. Mabo P, Victor F, Bazin P, Ahres S, Babuty D, Da Costa A, Binet D, Daubert JC; COMPAS Trial Investigators. A randomized trial of long- term remote monitoring of pacemaker recipients (the COMPAS trial). Eur Heart J. 2012;33:1105-1111. sourcePartly supported

  The Results (Interim follow-ups) report fewer ambulatory visits in the remote-monitoring group, and the Abstract (Methods and results) reports fewer hospitalizations for atrial arrhythmias and strokes. But the Results (Analysis of major adverse clinical events) do not show fewer cardiovascular hospitalizations overall (37 versus 33); the claim omits the restriction to specific causes. The cited COMPAS trial studied pacemaker recipients, not the heart-failure trial named in the citing sentence. (LLM, conf=0.89)

  Experimental — accuracy not yet measured

May combine two claims.

Driving does not appear to increase the risk of ICD shock; in the prospective case-crossover TOVA study of more than 1000 ICD patients, although there was an elevated risk of ventricular arrhythmia in the 1 hour after driving (relative risk of 2.24), there was no increased risk of arrhythmia during the driving episodes themselves.

“Driving does not appear to increase the risk of ICD shock; in the prospective case-crossover TOVA (Triggers of Ventricular Arrhythmia) study of >1000 ICD patients, although there was an elevated risk of ventricular arrhythmia in the 1 hour after driving (relative risk of 2.24), there was no increased risk of arrhythmia during the driving episodes themselves.88”

• cites [88] 88. Albert CM, Rosenthal L, Calkins H, Steinberg JS, Ruskin JN, Wang P, Muller JE, Mittleman MA; TOVA Investigators. Driving and implantable cardioverter-defibrillator shocks for ventricular arrhythmias: results from the TOVA study. J Am Coll Cardiol. 2007;50:2233-2240. sourcePartly supported

  Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  Experimental — accuracy not yet measured

May combine two claims.

Only 2 cases of shock failure during exercise, both on a treadmill, have been reported; one of which had a known Ethmozine-induced increase in defibrillation threshold and the other following very heavy alcohol ingestion.

“However, only 2 cases of shock failure during exercise, both on a treadmill, have been reported; one of which had a known Ethmozine-induced increase in defibrillation threshold 104 and the other following very heavy alcohol ingestion.105”

• cites [104] sourceSupported
• cites [105] sourceNot checked — no full text of the source

May combine two claims.

In a series of young athletes who experienced sudden cardiac death, the relative risk for athletes was 2.5, most of whom die during exercise.

“and, in a series of young athletes who experienced sudden cardiac death, the relative risk for athletes was 2.5, 92 most of whom die during exercise.92,93”

• cites [92] 92. Corrado D, Basso C, Rizzoli G, Schiavon M, Thiene G. Does sports activity enhance the risk of sudden death in adolescents and young adults? J Am Coll Cardiol. 2003;42:1959-1963. sourceSupported
• cites [93] 93. Maron BJ, Shirani J, Poliac LC, Mathenge R, Roberts WC, Mueller FO. Sudden death in young competitive athletes. Clinical, demographic, and pathological profiles. JAMA. 1996;276:199-204. sourceNot checked — no full text of the source

May combine two claims.

In the ICD Sports Safety Registry, shocks occurred at similar rates during competition or practice (10% of participants) and during other physical activity (8%), but were statistically less common at rest (6%).

“Shocks occurred at similar rates during competition or practice, occurring in 10% of participants, as during other physical activity, occurring in 8%, although were statistically less common at rest, occurring in 6%.”

• cites [106] sourceSupported

May combine two claims.

Data on the impact of antiarrhythmic drugs on the defibrillation threshold are variable, but 1 randomized study has suggested that amiodarone may increase, whereas sotalol and beta-blockers decrease, the defibrillation threshold.

“Data on the impact of antiarrhythmic drugs, used for atrial and ventricular arrhythmias, as well, on the defibrillation threshold are variable, but 1 randomized study 76 has suggested that amiodarone may increase, whereas sotalol and β-blockers decrease, the defibrillation threshold.”

• cites [76] 76. Hohnloser SH, Dorian P, Roberts R, Gent M, Israel CW, Fain E, Champagne J, Connolly SJ. Effect of amiodarone and sotalol on ven- tricular defibrillation threshold: the optimal pharmacological ther- apy in cardioverter defibrillator patients (OPTIC) trial. Circulation. 2006;114:104-109. sourceSupported

May combine two claims.

Exercise increases potassium, decreases pH, increases catecholamines, and can induce ischemia, any of which could potentially increase the defibrillation threshold.

“Exercise increases potassium, 98 decreases pH, 99 increases catecholamines, 100 and can induce ischemia, any of which could potentially increase the defibrillation threshold.95,[101][102][103]”

• cites [98] 98. Medbø JI, Sejersted OM. Plasma potassium changes with high intensity exercise. J Physiol. 1990;421:105-122. sourceNot checked — no full text of the source
• cites [99] 99. Osnes JB, Hermansen L. Acid-base balance after maximal exercise of short duration. J Appl Physiol. 1972;32:59-63. 100. Kjaer M. Epinephrine and some other hormonal responses to exercise in man: with special reference to physical training. Int J Sports Med. 1989;10:2-15. 101. Sims JJ, Miller AW, Ujhelyi MR. Regional hyperkalemia increases ven- tricular defibrillation energy requirements: role of electrical heterogene- ity in defibrillation. J Cardiovasc Electrophysiol. 2000;11:634-641. 102. Sousa J, Kou W, Calkins H, Rosenheck S, Kadish A, Morady F. Effect of epinephrine on the efficacy of sourceNot checked — no full text of the source
• cites [100] 100. Heidbuchel H, Hoogsteen J, Fagard R, Vanhees L, Ector H, Willems R, Van Lierde J. High prevalence of right ventricular involvement in endur- ance athletes with ventricular arrhythmias. Role of an electrophysiologic study in risk stratification. European Heart Journal. 2003;24:1473-1480. sourceCould not verify

  The Evaluation and Treatment and outcome sections discuss exercise testing, adrenergic tone, and ICD shocks, but do not address defibrillation thresholds. Searches for defibrillation threshold, potassium, pH, catecholamines, and ischemia found no passage linking exercise-related changes to a higher threshold. (LLM, conf=0.72)

  Experimental — accuracy not yet measured

May combine two claims.

In the Physician's Health Study, although sudden cardiac death increased during exercise, habitual vigorous exercise reduced the risk of sudden cardiac death during exercise 7-fold.

“In the Physician's Health Study, although sudden cardiac death increased during exercise, habitual vigorous exercise reduced the risk of sudden cardiac death during exercise 7-fold.91”

• cites [91] 91. Albert CM, Mittleman MA, Chae CU, Lee IM, Hennekens CH, Manson JE. Triggering of sudden death from cardiac causes by vigorous exertion. N Engl J Med. 2000;343:1355-1361. sourceSupported

May combine two claims.

In the ICD Sports Safety Registry, freedom from lead malfunction was 97% at 5 years from implant and 90% at 10 years, similar to previously reported malfunction rates in unselected populations.

“Freedom from lead malfunction was 97% at 5 years (from implant) and 90% at 10 years, similar to previously-reported malfunction rates in unselected populations.66”

• cites [106] sourceSupported
• cites [66] 66. Kramer DB, Maisel WH. Guidelines for managing pacemaker and implant- able defibrillator advisories. In: Ellenbogen KA, ed. Clinical Cardiac Pacing, Defibrillation, and Resynchronization Therapy. Philadelphia, PA: Elsevier Saunders; 2011. sourceNot checked — no full text of the source

May combine two claims.

Inactive individuals are at increased risk of development of coronary artery disease, cardiac arrest, and death.

“Inactive individuals are at increased risk of development of coronary artery disease, 113 cardiac arrest, 114 and death.111”

• cites [113] sourceNot checked — no full text of the source
• cites [114] sourceNot checked — no full text of the source
• cites [111] sourceCould not verify

  Citation 111 is attached to “death.” The Premises section (page unavailable) says sudden death can occur during sedentary activity, but does not say inactive individuals have a higher risk of death than active individuals. A search for inactivity, mortality, and comparative risk found no passage establishing that claim. (LLM, conf=0.76)

  Experimental — accuracy not yet measured

May combine two claims.

Although some studies have shown frequent brisk walking to be as beneficial as more vigorous exercise, most show a graded effect of exertion.

“Although some studies have shown frequent brisk walking to be as beneficial as more vigorous exercise, 114 most show a graded effect of exertion.111,113”

• cites [114] sourceNot checked — no full text of the source
• cites [111] sourceCould not verify

  Citation 114 is attached to the claim that frequent brisk walking can be as beneficial as more vigorous exercise, not to the later claim about graded effects. The Scope of the Problem discusses benefits of moderate exercise, and the Patient Recommendations list brisk walking as an acceptable low-intensity activity for patients with genetic cardiovascular diseases. Neither passage compares the benefits of brisk walking with those of vigorous exercise. (LLM, conf=0.76)

  Experimental — accuracy not yet measured
• cites [113] sourceNot checked — no full text of the source

May combine two claims.

The benefits of exercise are well-described, improving survival in healthy individuals and in patients with known coronary disease.

“The benefits of exercise are well-described, improving survival in healthy individuals 111 and in patients with known coronary disease, as well.112”

• cites [111] sourceCould not verify

  Citation 112 is attached to the claim that exercise improves survival in patients with known coronary disease. The Scope of the Problem section describes general health benefits of exercise, but does not report a survival benefit in that population. Searches for coronary disease, survival, and mortality found no passage establishing the cited claim. (LLM, conf=0.76)

  Experimental — accuracy not yet measured
• cites [112] sourceNot checked — no full text of the source

May combine two claims.

In the ICD Sports Safety Registry, there were no occurrences of either primary endpoint-death or resuscitated arrest, or arrhythmia- or shock-related injury-during sports.

“However, there were no occurrences of either primary endpoint: 1) death or resuscitated arrest, or 2) arrhythmia-or shock-related injury, during sports.”

• cites [106] sourceSupported

May combine two claims.

Twenty percent of ICD patients receive shocks in the last weeks, days, or hours of their lives, decreasing their quality of life and that of their families.

“Twenty percent of ICD patients receive shocks in the last weeks, days, or hours of their lives, decreasing their QOL, and that of their families, as well.33”

• cites [33] 33. Goldstein NE, Lampert R, Bradley E, Lynn J, Krumholz HM. Management of implantable cardioverter defibrillators in end-of-life care. Ann Intern Med. 2004;141:835-838. sourceNot checked — no full text of the source

May combine two claims.

Low social support is a predictor of poor quality of life for patients with ICDs, in particular the absence of a spouse.

“Low social support is also a predictor of poor QOL for patients with ICDs, 12,14 in particular, the absence of a spouse.”

• cites [12] 12. Sears SF, Lewis TS, Kuhl EA, Conti JB. Predictors of quality of life in patients with implantable cardioverter defibrillators. Psychosomatics. 2005;46:451-457. sourceNot checked — no full text of the source
• cites [14] 14. Luyster FS, Hughes JW, Waechter D, Josephson R. Resource loss predicts depression and anxiety among patients treated with an implantable cardio- verter defibrillator. Psychosom Med. 2006;68:794-800. sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S4 (based).

A consequence of remote follow-up has been a decrease in the amount of time electrophysiologists may spend face-to-face with patients.

“However, a consequence of remote follow-up has been a decrease in the amount of time electrophysiologists may spend face-to-face with patients”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Cardiac resynchronization devices have improved mortality, morbidity, and quality of life for patients with heart failure.

“cardiac resynchronization devices have improved mortality, morbidity, and quality of life for patients with heart failure”

• cites [1] 1. Goldberger Z, Lampert R. Implantable cardioverter-defibrillators: expand- ing indications and technologies. JAMA. 2006;295:809-818. sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S4 (based). May combine two claims.

Communication between physician and patient at the time of implantation regarding a plan of action on receipt of a shock will reduce patient anxiety and often unnecessary resource use.

“Communication between physician and patient at the time of implantation regarding a plan of action on receipt of a shock will reduce patient anxiety and often unnecessary resource use, as well.”

Probably not a substantial claim: may not pass S2 (checkable), S4 (based).

With careful attention by the healthcare team, both shocks and their impact can be reduced.

“However, with careful attention by the healthcare team, both shocks and their impact can be reduced.”

Probably not a substantial claim: may not pass S4 (based).

Lead or device malfunction can result in unnecessary shocks.

“Lead or device malfunction can result in unnecessary shocks”

May combine two claims.

US courts have consistently ruled that adult patients have a constitutional right to refuse any treatment, including life-sustaining treatments, and that there is no legal difference between withdrawing an ongoing treatment and not starting it in the first place.

“US courts have consistently ruled that adult patients have a constitutional right to refuse any treatment, including life-sustaining treatments, and that there is no legal difference between withdrawing an ongoing treatment and not starting it in the first place. 32,34,35”

• cites [32] 32. Lampert R, Hayes DL, Annas GJ, Farley MA, Goldstein NE, Hamilton RM, Kay GN, Kramer DB, Mueller PS, Padeletti L, Pozuelo L, Schoenfeld MH, Vardas PE, Wiegand DL, Zellner R, American Heart Association; American College of Cardiology; American Geriatrics Society; American Academy of Hospice and Palliative Medicine; European Heart Rhythm Association; Hospice and Palliative Nurses Association. HRS Expert Consensus Statement on the Management of Cardiovascular Implantable Electronic Devices (CIEDs) in patients nearing end of life or requesting withdrawal of therapy. Heart Rhythm. 2010;7:1008-10 sourceNot checked — no full text of the source
• cites [34] 34. Annas GJ. "Culture of life" politics at the bedside-the case of Terri Schiavo. N Engl J Med. 2005;352:1710-1715. sourceNot checked — no full text of the source
• cites [35] 35. Annas GJ. The Rights of Patients: The Authoritative ACLU Guide to the Rights of Patients. New York, NY: New York University Press; 2004.Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

In the single-center study of 308 ICD recipients, psychopathology decreased at 1 year overall, but not in patients who had received shocks from the ICD.

“In this study, psychopathology decreased at 1 year overall, but not in patients who had received shocks from the ICD.”

• cites [17] 17. Kapa S, Rotondi-Trevisan D, Mariano Z, Aves T, Irvine J, Dorian P, Hayes DL. Psychopathology in patients with ICDs over time: results of a pro- spective study. Pacing Clin Electrophysiol. 2010;33:198-208. sourceNot checked — no full text of the source

May combine two claims.

A systematic review of 45 studies that assessed more than 5000 patients reported that between 11% and 28% of patients had a depressive disorder and 11% to 26% had an anxiety disorder.

“A recent systematic review of 45 studies that assessed >5000 patients reported that between 11% and 28% of patients had a depressive disorder, and 11% to 26% had an anxiety disorder.16”

• cites [16] 16. Magyar-Russell G, Thombs BD, Cai JX, Baveja T, Kuhl EA, Singh PP, Montenegro Braga Barroso M, Arthurs E, Roseman M, Amin N, Marine JE, Ziegelstein RC. The prevalence of anxiety and depression in adults with implantable cardioverter defibrillators: a systematic review. J Psychosom Res. 2011;71:223-231. sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Recalls can cause anxiety.

“recalls can cause anxiety”

Classified as probably not a substantial claim.

Because of the impact of shocks on quality of life, decreasing shocks over the long term is a key factor in managing ICD patients.

“Because of the impact of shocks on QOL, decreasing shocks over the long term is a key factor in managing ICD patients.”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Remote monitoring increases the ease of follow-up for patients and physicians.

“Remote monitoring increases the ease of follow-up for patients and physicians”

May combine two claims.

Studies evaluating both general and ICD-specific measures suggest that although general quality of life is similar to the age-matched population, ICD patients express ICD-specific concerns.

“Studies that have evaluated both general and ICD-specific measures suggest that, although general QOL is similar to the age-matched population, ICD patients express ICD-specific concerns.”

• cites 6,,7Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

In the CIDs trial, patients who received no shocks or 1 to 4 shocks had significant improvement in quality of life over time, whereas those with 5 or more shocks did not improve.

“In the Canadian Implantable Defibrillator (CIDs) trial, 9 although those patients who received either no shocks or 1 to 4 shocks had significant improvement in QOL over time, those with 5 or more shocks did not improve.”

• cites [9] 9. Irvine J, Dorian P, Baker B, O'Brien BJ, Roberts R, Gent M, Newman D, Connolly SJ. Quality of life in the Canadian Implantable Defibrillator Study (CIDS). Am Heart J. 2002;144:282-289. sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S4 (based).

Remote monitoring may improve timeliness of management.

“and may improve timeliness of management”

May combine two claims.

Posttraumatic stress disorder is increased in patients with ICDs, with a single-center study of 308 ICD recipients describing a rate of 35% for significant anxiety or posttraumatic stress disorder after implant.

“Posttraumatic stress disorder is also increased in patients with ICDs, with a recent single-center study of 308 ICD recipients describing a rate of 35% for significant anxiety or posttraumatic stress disorder after implant.17”

• cites [17] 17. Kapa S, Rotondi-Trevisan D, Mariano Z, Aves T, Irvine J, Dorian P, Hayes DL. Psychopathology in patients with ICDs over time: results of a pro- spective study. Pacing Clin Electrophysiol. 2010;33:198-208. sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

Pacemakers have been improving symptoms in patients with bradyarrhythmias for decades.

“pacemakers (PMs) have been improving symptoms in patients with bradyarrhythmias for decades”

• cites [1] 1. Goldberger Z, Lampert R. Implantable cardioverter-defibrillators: expand- ing indications and technologies. JAMA. 2006;295:809-818. sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

Shocks at the end of life can be particularly devastating.

“Shocks at the end of life can be particularly devastating.”

May combine two claims.

The 2 prospective studies in this meta-analysis showed that device advisory may lead to increased anxiety and decreased confidence in the device.

“The 2 prospective studies in this metaanalysis showed that device advisory may lead to increased anxiety and decreased confidence in the device.”

• cites [71] 71. Pedersen SS, van den Berg M, Theuns DA. A viewpoint on the impact of device advisories on patient-centered outcomes. Pacing Clin Electrophysiol. 2009;32:1006-1011. sourceNot checked — no full text of the source

May combine two claims.

In the randomized TRUST trial, remote monitoring reduced the total number of in-person evaluations, improved adherence, and resulted in more rapid evaluation of events with more rapid initiation of indicated therapeutic interventions, although there was no difference in survival between the groups.

“In the randomized TRUST trial (Lumos-T Safely Reduces Routine Office Device Follow-Up, 1339 patients), remote monitoring reduced the total number of in-person evaluations, improved adherence, and resulted in more rapid evaluation of events with more rapid initiation of indicated therapeutic interventions such as medications or programming changes, although there was no difference in survival”

• cites [55] 55. Varma N, Epstein AE, Irimpen A, Schweikert R, Love C; TRUST Investigators. Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial. Circulation. 2010;122:325-332. sourceNot checked — no full text of the source

May combine two claims.

Although most physicians are comfortable with the deactivation of an ICD, some describe less comfort with PM deactivation, particularly in PM-dependent patients.

“Although most physicians are comfortable with the deactivation of an ICD, some describe less comfort with PM deactivation, particularly in PM-dependent patients. 36,37”

• cites [36] 36. Mueller PS, Jenkins SM, Bramstedt KA, Hayes DL. Deactivating implanted cardiac devices in terminally ill patients: practices and attitudes. Pacing Clin Electrophysiol. 2008;31:560-568. sourceNot checked — no full text of the source
• cites [37] 37. Kay GN, Bittner GT. Should implantable cardioverter-defibrillators and permanent pacemakers in patients with terminal illness be deactivated? Deactivating implantable cardioverter-defibrillators and permanent pace- makers in patients with terminal illness. An ethical distinction. Circ Arrhythm Electrophysiol. 2009;2:336-339; discussion 339. sourceNot checked — no full text of the source

May combine two claims.

Although remote monitoring provides clinical and convenience-related advantages, the use of these systems is not universal, with only two-thirds of eligible patients enrolled in 1 company's system.

“Although remote monitoring provides clinical and convenience-related advantages as described, the use of these systems is not universal, with only two-thirds of eligible patients enrolled in 1 company's system.62”

• cites [62] 62. Movsowitz C, Mittal S. Remote patient management using implantable devices. J Interv Card Electrophysiol. 2011;31:81-90. sourceNot checked — no full text of the source

May combine two claims.

Recalls, and perhaps the surrounding negative press, impact device patients' quality of life.

“Furthermore, recalls, and perhaps the surrounding negative press, impact device patients' QOL.”

May combine two claims.

As described by the Supreme Court, there are 2 key differences between withdrawal of unwanted therapies and assisted suicide: clinician intent and the cause of death.

“However, as described by the Supreme Court, 39 there are 2 key differences between withdrawal of unwanted therapies and assisted suicide.First is clinician intent-withdrawing an unwanted therapy, versus hastening death 40,41 -and second is the cause of death.”

• cites [39] 39. Vacco v Quill, 521 US 793, 95-1858 (1997).Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [40] 40. Meisel A, Snyder L, Quill T; American College of Physicians-American Society of Internal Medicine End-of-Life Care Consensus Panel. Seven legal barriers to end-of-life care: myths, realities, and grains of truth. JAMA. 2000;284:2495-2501. sourceNot checked — no full text of the source
• cites [41] 41. Snyder L, Leffler C; Ethics and Human Rights Committee, American College of Physicians. Ethics manual: fifth edition. Ann Intern Med. 2005;142:560-582. sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Since 1990, more than 60 device or lead advisories have been announced, affecting more than 1 million device patients.

“Since 1990, >60 device or lead advisories have been announced, affecting >1 million device patients.66”

• cites [66] 66. Kramer DB, Maisel WH. Guidelines for managing pacemaker and implant- able defibrillator advisories. In: Ellenbogen KA, ed. Clinical Cardiac Pacing, Defibrillation, and Resynchronization Therapy. Philadelphia, PA: Elsevier Saunders; 2011. sourceNot checked — no full text of the source

May combine two claims.

Both PM and ICD patients may fear loss of device function, whereas ICD patients additionally may be faced with inappropriate shocks.

“Both PM and ICD patients may fear loss of device function, whereas ICD patients additionally may be faced with inappropriate shocks.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Two documents from the Heart Rhythm Society have addressed the management of device and lead recalls.

“Two documents from the Heart Rhythm Society have addressed the management of device 72 and lead 73 recalls.”

• cites [72] 72. Carlson MD, Wilkoff BL, Maisel WH, Carlson MD, Ellenbogen KA, Saxon LA, Prystowsky EN, Alpert JS, Cain ME, Ching EA, Curtis AB, Davies DW, Hammill SC, Hauser RG, Lampert R, Zipes DP. Recommendations from the Heart Rhythm Society task force on device performance policies and guidelines. Heart Rhythm. 2006;3:1250-1273 sourceNot checked — no full text of the source
• cites [73] 73. Maisel WH, Hauser RG, Hammill SC, Ellenbogan KA, Epstein AE, Hayes DL, Alpert JS, Berger RD, Curtis AB, Dubin AM, Estes NA, Gura MT, Krahn AD, Lampert R, Lindsay BD, WIlkoff BL. Recommendations from the Heart Rhythm Society task force on lead performance policies and guidelines. Heart Rhythm. 2009;6:869-885 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S2 (checkable).

Timely and effective communication among patients, families, and healthcare providers is essential to prevent unwanted shocks at the end of life.

“Timely and effective communication among patients, families, and healthcare providers is essential to prevent unwanted shocks at the end of life”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Current recommended minimum frequency of monitoring for patients with cardiovascular implantable electronic devices is once per year in person and every 3 to 6 months for ICD or 3 to 12 months for PM either remotely or in the office.

“Current recommended minimum frequency of monitoring for patients with cardiovascular implantable electronic devices is once per year in person and every 3 to 6 (ICD) or 3 to 12 (PM) months either remotely or in the office.51”

• cites [51] 51. Wilkoff BL, Auricchio A, Brugada J, Cowie M, Ellenbogen KA, Gillis AM, Hayes DL, Howlett JG, Kautzner J, Love CJ, Morgan JM, Priori SG, Reynolds DW, Schoenfeld MH, Vardas PE; Heart Rhythm Society; European Heart Rhythm Association; American College of Cardiology; American Heart Association; European Society of Cardiology; Heart Failure Association of ESC; Heart Failure Society of America. HRS/ EHRA expert consensus on the monitoring of cardiovascular implantable electronic devices (CIEDs): description of techniques, indications, person- nel, frequency and ethical considerations. Heart Rhyt sourceNot checked — no full text of the source

May combine two claims.

In assisted suicide or euthanasia, death is caused by the intervention provided, prescribed, or administered by the clinician; in contrast, when a patient dies after a treatment is refused or withdrawn, the cause of death is the underlying disease.

“In assisted suicide or euthanasia, death is caused by the intervention provided, prescribed, or administered by the clinician.In contrast, when a patient dies after a treatment is refused or withdrawn, the cause of death is the underlying disease.”

• cites [40] 40. Meisel A, Snyder L, Quill T; American College of Physicians-American Society of Internal Medicine End-of-Life Care Consensus Panel. Seven legal barriers to end-of-life care: myths, realities, and grains of truth. JAMA. 2000;284:2495-2501. sourceNot checked — no full text of the source
• cites [41] 41. Snyder L, Leffler C; Ethics and Human Rights Committee, American College of Physicians. Ethics manual: fifth edition. Ann Intern Med. 2005;142:560-582. sourceNot checked — no full text of the source

May combine two claims.

Lead or device malfunction and recalls lead to morbidity, mortality, and the need for invasive procedures.

“Lead or device malfunction and recalls lead to morbidity, mortality, and the need for invasive procedures, [67][68][69]”

• cites [67] 67. Hauser RG, Hayes DL. Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure. Heart Rhythm. 2009;6:605-610. sourceNot checked — no full text of the source
• cites [68] 68. Maytin M, Love CJ, Fischer A, Carrillo RG, Garisto JD, Bongiorni MG, Segreti L, John RM, Michaud GF, Albert CM, Epstein LM. Multicenter experience with extraction of the Sprint Fidelis implantable cardioverter- defibrillator lead. J Am Coll Cardiol. 2010;56:646-650. sourceNot checked — no full text of the source
• cites [69] 69. Ellenbogen KA, Wood MA, Swerdlow CD. The Sprint Fidelis lead frac- ture story: what do we really know and where do we go from here? Heart Rhythm. 2008;5:1380-1381. sourceNot checked — no full text of the source

May combine two claims.

One recent study suggested no change in standard measures of depression, anxiety, and device-specific concern in patients with leads under advisory compared with controls, but significant psychological morbidity in patients with actual lead fracture, mostly related to inappropriate shocks.

“One recent study suggested no change in standard measures of depression, anxiety, and device-specific concern in patients with leads under advisory compared with controls, but significant psychological morbidity in patients with actual lead fracture, mostly related to inappropriate shocks.70”

• cites [70] 70. Keren A, Sears SF, Nery P, Shaw J, Green MS, Lemery R, Gollob MH, Amyotte B, Birnie DH. Psychological adjustment in ICD patients living with advisory fidelis leads. J Cardiovasc Electrophysiol. 2011;22:57-63. sourceNot checked — no full text of the source

Classified as probably not a substantial claim. May combine two claims.

Both documents emphasized the importance of communication, not just between industry and physicians, but between industry and patients, resulting in the implementation of direct patient communication about important device and lead performance issues.

“Both of these documents emphasized the importance of communication, not just between industry and physicians, but between industry and patients, resulting in the implementation of direct patient communication about important device and lead performance issues.”

• cites [72] 72. Carlson MD, Wilkoff BL, Maisel WH, Carlson MD, Ellenbogen KA, Saxon LA, Prystowsky EN, Alpert JS, Cain ME, Ching EA, Curtis AB, Davies DW, Hammill SC, Hauser RG, Lampert R, Zipes DP. Recommendations from the Heart Rhythm Society task force on device performance policies and guidelines. Heart Rhythm. 2006;3:1250-1273 sourceNot checked — no full text of the source
• cites [73] 73. Maisel WH, Hauser RG, Hammill SC, Ellenbogan KA, Epstein AE, Hayes DL, Alpert JS, Berger RD, Curtis AB, Dubin AM, Estes NA, Gura MT, Krahn AD, Lampert R, Lindsay BD, WIlkoff BL. Recommendations from the Heart Rhythm Society task force on lead performance policies and guidelines. Heart Rhythm. 2009;6:869-885 sourceNot checked — no full text of the source

May combine two claims.

Antiarrhythmic drugs can also slow the rate of ventricular tachycardia, potentially below the rate cutoff currently programmed, or can be proarrhythmic.

“These and other antiarrhythmic drugs can also slow the rate of ventricular tachycardia, potentially below the rate cutoff currently programmed, or can be proarrhythmic.77”

• cites [77] 77. Reiffel JA, Coromilas J, Zimmerman JM, Spotnitz HM. Drug-device interactions: clinical considerations. Pacing Clin Electrophysiol. 1985;8(3 pt 1):369-373. sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S4 (based).

Sports participation could lead to damage to the ICD system because of direct trauma or repetitive arm motion.

“Finally, sports participation could lead to damage to the ICD system because of direct trauma or repetitive arm motion.”

May combine two claims.

Because up to 50% of secondary prevention patients will have ICD-treated arrhythmias, of which 30% result in loss of consciousness, the risk of sudden incapacitation is 10%.

“Because up to 50% of secondary prevention patients will have ICD-treated arrhythmias, of which 30% result in loss of consciousness, the risk of sudden incapacitation is 10%.”

• cites [84] 84. Consensus Conference CCS. Assessment of the cardiac patient for fitness to drive. Can J Cardiol. 1992;8:406-412Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Although 8% experienced a shock while driving, the accident rate was 3.4% overall, actually lower than the 7% in the general population.

“Although 8% experienced a shock while driving, the accident rate was 3.4% overall, actually lower than the 7% in the general population.87”

• cites [87] 87. Akiyama T, Powell JL, Mitchell LB, Ehlert FA, Baessler C; Antiarrhythmics versus Implantable Defibrillators Investigators. Resumption of driv- ing after life-threatening ventricular tachyarrhythmia. N Engl J Med. 2001;345:391-397. sourceNot checked — no full text of the source

Classified as probably not a substantial claim.

Following PM implantation, or generator replacement of either PM or ICD, 1 week before resumption of driving is recommended to allow healing.

“Following PM implantation, or generator replacement of either PM or ICD, 1 week before resumption of driving is recommended to allow healing.”

May combine two claims.

Drugs can impact device patients through changes in defibrillation, arrhythmia characteristics, sensing, pacing, defibrillation, and interactions with programming.

“Drugs can impact device patients through changes in defibrillation, arrhythmia characteristics, sensing, pacing, defibrillation, and interactions with programming”

May combine two claims.

Among patients enrolled in AVID and randomly assigned to the ICD, one-half had resumed driving within 3 months, and 88% within a year.

“Among patients enrolled in AVID and randomly assigned to the ICD, one-half had resumed driving within 3 months, and 88% within a year.”

• cites [87] 87. Akiyama T, Powell JL, Mitchell LB, Ehlert FA, Baessler C; Antiarrhythmics versus Implantable Defibrillators Investigators. Resumption of driv- ing after life-threatening ventricular tachyarrhythmia. N Engl J Med. 2001;345:391-397. sourceNot checked — no full text of the source

May combine two claims.

These changes in defibrillation threshold were of small magnitude in most, suggesting that follow-up testing is probably not necessary.

“However, these changes were of small magnitude in most, suggesting that follow-up testing is probably not necessary.”

Classified as probably not a substantial claim.

Professional driving is prohibited based on the higher risk owing to the increased time driving and increased risk of injury from accidents involving larger vehicles.

“Professional driving is prohibited based on the higher risk owing to the increased time driving and increased risk of injury from accidents involving larger vehicles.”

May combine two claims.

Many heart failure drugs can cause hyperkalemia, which can lead to T-wave oversensing and inappropriate shocks.

“Further, many heart failure drugs can cause hyperkalemia, which can lead to T-wave oversensing 78 and inappropriate shocks.”

• cites [78] 78. Koul AK, Keller S, Clancy JF, Lampert R, Batsford WP, Rosenfeld LE. Hyperkalemia induced T wave oversensing leading to loss of biventricu- lar pacing and inappropriate ICD shocks. Pacing Clin Electrophysiol. 2004;27:681-683. sourceNot checked — no full text of the source

Classified as probably not a substantial claim. May combine two claims.

Based on these and similar calculations, the recommended period of restriction from driving is 6 months for secondary prevention patients and 1 week for primary prevention patients, with further restriction if appropriate ICD therapy is received.

“Based on these and similar calculations, the recommended period of restriction from driving is 6 months for secondary prevention patients and 1 week for primary prevention patients (to allow healing), with further restriction if appropriate ICD therapy is received”

• cites [80] 80. Epstein AE, Baessler CA, Curtis AB, Estes NA 3rd, Gersh BJ, Grubb B, Mitchell LB; American Heart Association; Heart Rhythm Society. Addendum to "Personal and Public Safety Issues Related to Arrhythmias That May Affect Consciousness: Implications for Regulation and Physician Recommendations. A medical/scientific statement from the American Heart Association and the North American Society of Pacing and Electrophysiology." Public safety issues in patients with implantable defibrillators. A Scientific statement from the American Heart Association and the Heart Rhythm Society. Heart Rhythm. 200 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

Common sense suggestions for other at-risk cardiac populations have included the avoidance of excessive activity or extreme weather conditions (such as skiing all day or in a snowstorm) or extreme sports such as hang-gliding.

“Common sense suggestions for other at-risk cardiac populations have included the avoidance of excessive activity or extreme weather conditions (skiing all day or in a snowstorm) or extreme sports such as hang-gliding.110”

• cites [110] sourceNot checked — no full text of the source

Classified as probably not a substantial claim.

Level of contact, level of competition, and adequacy of escape rhythm had the largest influence on recommendations.

“Level of contact, level of competition, and adequacy of escape rhythm had the largest influence on recommendations.”

• cites [115] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S2 (checkable).

The common sense suggestions for other at-risk cardiac populations should apply to ICD patients as well.

“These should apply to ICD patients as well.”

Probably not a substantial claim: may not pass S4 (based).

The impact of ICD and PM therapies on many aspects of quality of life can be substantial.

“Although ICDs and PMs are life-saving, the impact of these therapies on many aspects of QOL can be substantial.”

• AssumptionRests on an assumption: ICDs and PMs are life-saving.