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1 | Area of Research | No | Title | Author | Journal | Publishing Date | n | Main Conclusions | Link | Search Term | Outcome Parameter | Manufactuer mentioned | Abstract with all details | |||||||||||||
2 | Cardiology | ICD | Outcome Based Comparison | 1 | Long-term patient satisfaction with implanted device remote monitoring: a comparison among different systems | Jessica Artico 1, Massimo Zecchin 1, Anna Zorzin Fantasia 1, Giulia Skerl 1, Benedetta Ortis 1, Stefania Franco 1, Stefano Albani 1, Giulia Barbati 2, Jacopo Cristallini 1, Antonio Cannata' 1, Gianfranco Sinagra 1 | Journal of Cardiovascular Medicine | 2019 | 604 | Daily impact of cardiac implantable electronic devices still remains a challenging issue for caregivers. The introduction of remote monitoring allowed closer follow-up and improved outcomes. Our results highlighted patients’ satisfaction, who also felt safer, with the remote monitoring, its ease of use, and the absence of any disturbances in patients’ everyday activities or in their privacy. | https://pubmed.ncbi.nlm.nih.gov/31107287/ | internal defibrillators manufacturers comparison | QoL | no | n | |||||||||||
3 | Cardiology | ICD | Outcome Based Comparison | 2 | Cognitive performance in patients with implantable cardioverter defibrillators: Associations with objective sleep duration, age and anxiety | Ashley F. Curtis, Alicia J. Roth, Samuel F. Sears, Jamie B. Conti, Richard B. Berry, Joseph M. Dzierzewski, Himangshu Rathinakumar, Christina S. McCrae | Journal of Sleep Research | 2018 | 41 | To our knowledge, the present study is the first to examine associations between sleep and cognition in patients with ICDs. Results suggest that regardless of patient age, objectively assessed sleep duration may play an important role in the prediction of executive function and a lower-order task measuring attention and processing speed in patients with an ICD and self-reported sleep disturbance. Given that cognitive function is associated with quality of life in ICD patients (Moulaert et al., 2010), as well as functional independence in older adults (Mehta, Yaffe, & Covinsky, 2002), who were widely represented in the present analysis, the results may inform clinical applications related to sleep and ageing, and potentially facilitate the management of cognitive aspects of daytime functioning. | https://onlinelibrary.wiley.com/doi/full/10.1111/jsr.12810 | internal defibrillators manufacturers comparison | psychological/sleep | no | n, age | |||||||||||
4 | Cardiology | ICD | Outcome Based Comparison | 3 | Associations between pain, objective sleep efficiency and cognition in patients with implantable cardioverter defibrillators | Ashley F.CurtisabAlicia J.RothcSamuel F.SearsdeJamie B.ContifRichard B.BerrygJoseph M.DzierzewskihChristina S.McCraea | Sleep Medicine | 2020 | 37 | Similar to previous research on subjective sleep in fibromyalgia (Fang et al., 2019), we found no independent associations between objective SE or pain on cognition. It may be only in the context of worse pain where sleep fragmentation/lower level cognition associations arise. Absence of associations between SE/pain and higher order cognition (reasoning, working memory) is somewhat surprising, given previous findings of associations between objective sleep duration and these tasks in ICD patients (Curtis et al., 2018). However, research suggests sleep fragmentation is uniquely associated with brain regions associated with attention (Kingshott, Cosway, Deary, & Douglas, 2000), and there is substantial overlap between these neural regions and pain processing (Forn et al., 2009; Torta & Cauda, 2011). We speculate that more fragmented sleep may exacerbate pain-related attention deficits in patients with disturbed sleep and more severe pain. It is possible that ICD patients with worse pain may benefit most in aspects of cognitive functioning (greater improvement in attention/processing speed) from interventions (e.g., Cognitive Behavioral Therapy for Insomnia) aimed at improving SE.In ICD patients with sleep disturbance, associations between objective SE and cognition may depend on pain level. ICD patients with worse pain may be most vulnerable to effects of worse sleep fragmentation on sustained attention/processing speed. Pain level should be considered in the understanding and treatment of daytime dysfunction related to poor sleep in these patients. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7987212/ | internal defibrillators manufacturers comparison | psychological | no | n, age | |||||||||||
5 | Cardiology | ICD | Outcome Based Comparison | 4 | Living with a pacemaker: patient-reported outcome of a pacemaker system | Peter Magnusson & Per Liv | BMC Cardiovascular Disorders volume | 2018 | 342 | The vast majority of patients report excellent overall satisfaction with the pacemaker system, and are not affected by pain, soreness/discomfort, or concern about device malfunction. They also reported favourable outcomes with respect to cosmetic results, shoulder movement, and sleep. However, some patients underwent a surgical correction of the pacemaker pocket. | https://bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-018-0849-6 | QoL | no | n, age, follow up | ||||||||||||
6 | Cardiology | ICD | Outcome Based Comparison | 5 | Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator: primary results of the REMOTE-CIED randomized trial | Henneke Versteeg, Ivy Timmermans, Jos Widdershoven, Geert-Jan Kimman, Sébastien Prevot, Thomas Rauwolf, Marcoen F Scholten, Edgar Zitron, Philippe Mabo, Johan Denollet, Susanne S Pedersen, Mathias Meine | EP Europace | 2019 | 595 | Large clinical trials have indicated that RPM can safely and effectively replace most in-clinic check-ups of ICD patients. The REMOTE-CIED trial results show that patient-reported health status and ICD acceptance do not differ between patients on RPM and patients receiving in-clinic check-ups alone in the first 2 years after ICD implantation. | https://academic.oup.com/europace/article/21/9/1360/5511581?login=true | Health Status & ICD acceptance | Boston Scientific Latitute RPM | manufacturer, n, follow up period | ||||||||||||
7 | Cardiology | ICD | Outcome Based Comparison | 6 | Health Status and Depression Remission in Patients With Chronic Heart Failure | Glen L. Xiong , Mona Fiuzat , Maragatha Kuchibhatla , Ranga Krishnan , Christopher M. O’Connor , Wei Jiang and on behalf of the SADHART-CHF Investigators | Circulation: Heart Failure | 2012 | 469 | Patients with heart failure whose depressive symptoms remitted had significantly greater improvement in physical function, social function, and quality of life. | https://www.ahajournals.org/doi/full/10.1161/CIRCHEARTFAILURE.112.967620 | patient reported outcomes implantable cardiac defibrillator | Psychological | no | n | |||||||||||
8 | Cardiology | ICD | Outcome Based Comparison | 7 | Monitoring Device Acceptance in Implantable Cardioverter Defibrillator Patients Using the Florida Patient Acceptance Survey | HENNEKE VERSTEEG Ph.D., ANNEMIEKE STARRENBURG M.Sc., JOHAN DENOLLET Ph.D., JOB VAN DER PALEN Ph.D., SAMUEL F. SEARS Ph.D., SUSANNE S. PEDERSEN Ph.D. | Pacing and Clinical Electrophysiology | 2012 | 272 | A shortened 12-item, three-factor version of the FPAS was shown to be a valid and internally consistent instrument to assess device acceptance in Dutch ICD patients. Psychological but not clinical factors were the primary correlates of device acceptance, which underlines the importance of taking into account the patient's psychological profile when seeking to identify patients at risk for adjustment difficulties after ICD implantation. | https://onlinelibrary.wiley.com/doi/full/10.1111/j.1540-8159.2011.03299.x?casa_token=ayflMgPPWbQAAAAA%3AcDPFeOXNY7VN0cLMb-IQZ1ZocH5T8mFJtPRZx2I_ci_f3su8fW1VUvW0LRf04KWxMkEgGdRrptvCKSWI | patient reported outcomes implantable cardiac defibrillator | ICD acceptance/psycholohgy | no | n, mean age | |||||||||||
9 | Cardiology | ICD | Outcome Based Comparison | 8 | Management of patients receiving implantable cardiac defibrillator shocks: Recommendations for acute and long-term patient management | Frieder Braunschweig, Giuseppe Boriani, Alexander Bauer, Robert Hatala, Christoph Herrmann-Lingen, Josef Kautzner, Susanne S. Pedersen, Steen Pehrson, Renato Ricci, Martin J. Schalij | EP Europace | 2010 | N/A | N/A | https://academic.oup.com/europace/article/12/12/1673/431085?login=true | patient reported outcomes implantable cardiac defibrillator | expert consensus | Boston (Guidant/CPI), Medtronic, St Jude Medical, Sorin, Biotronik | n/a | |||||||||||
10 | Cardiology | ICD | Outcome Based Comparison | 9 | Pre implantation psychological functioning preserved in majority of implantable cardioverter defibrillator patients 12 months post implantation | Susanne S.PedersenabMadelein T.HoogwegtaLucJordaensbDominic A.M.J.Theunsb | International Journal of Cardiology | 2013 | 332 | The majority of ICD patients maintained their pre implantation level of psychological functioning at 12 months. A subset of patients was at risk of poor psychological adaptation, attributable to ICD shocks, Type D personality, atrial fibrillation, and left ventricular dysfunction, while primary prevention indication and older age had a protective effect against deterioration in functioning. | https://www.sciencedirect.com/science/article/pii/S0167527311019668?casa_token=UJBIF3RysM0AAAAA:_h3BnDcquPhBWpraYmCkjTExki4Z8tYxIM5q5tB6bI3C_By_Mwkd-txEhoqJIihXFL7u7kntgjM | patient reported outcomes implantable cardiac defibrillator | no | n, follow-up period | ||||||||||||
11 | Cardiology | ICD | Outcome Based Comparison | 10 | Prediction of Arrhythmic Events in Ischemic and Dilated Cardiomyopathy Patients Referred for Implantable Cardiac Defibrillator | Peng Gao , Raymond Yee , Lorne Gula , Andrew D. Krahn , Allan Skanes , Peter Leong-Sit , George J. Klein , John Stirrat , Nowell Fine , Luljeta Pallaveshi , Gerald Wisenberg , Terry R. Thompson , Frank Prato , Maria Drangova and James A. White | Circulation: Cardiovascular Imaging | 2012 | 124 | Myocardial scar quantification by LGE-CMR predicts arrhythmic events in patients being evaluated for ICD eligibility irrespective of cardiomyopathy etiology. | https://www.ahajournals.org/doi/full/10.1161/CIRCIMAGING.111.971549 | patient reported outcomes implantable cardiac defibrillator | not performance outcome/ scaring | no | n, follow-up period | |||||||||||
12 | Cardiology | ICD | Outcome Based Comparison | 11 | Australian implantable cardiac defibrillator recipients: Quality-of-life issues | Dianne Pelletier RN BSci(Nurs), DipEd, MasterSci(Soc), FCN, FRCNA, Robyn Gallagher RN Cardiothoracic Nursing Certificate, BA, MN, PhD, Suzanne Mitten-Lewis BA, Sharon McKinley RN BAppSc, PhD, Jill Squire RGN | International Journal of Nursing Practice | 2002 | 74 | One major element of the overall impact on the patient and family is the shock itself, and from this study, we report that despite the pain, the response to the single therapeutic shock is mostly positive. However, the issue of the effects of dysrhythmias and shock sequela on safety have not been adequately addressed. These aspects need to be considered in terms of what driving cessation means for the recipient and their family. There is a need for clearer guidance to be given to those wishing to drive. Patients can be taught more about the shock experience and the potential for using warning signs effectively. Nurses might find themselves well placed to participate in the education and ongoing support of this population whose numbers are likely to increase. | https://onlinelibrary.wiley.com/doi/full/10.1046/j.1440-172x.2002.00345.x?casa_token=JrpojK1L8oAAAAAA%3AdwGBsDSMzKavblPfTgsszWOD-WCvnnF6T1SL1rIdQc6T77ZN4klJpTj55rzlnSeAGCcj8awy7tvARc5R | patient reported outcomes implantable cardiac defibrillator | QoL | no | n, follow-up period | |||||||||||
13 | Cardiology | ICD | Outcome Based Comparison | 12 | Benefits of the Implantable Cardioverter-Defibrillator | Andrew E. Epstein | Journal of the American College of Cardiology | 2008 | N/A | N/A | https://www.jacc.org/doi/abs/10.1016/j.jacc.2008.06.035 | patient reported outcomes implantable cardiac defibrillator | commentary | n/a | n/a | |||||||||||
14 | Cardiology | ICD | Outcome Based Comparison | 13 | Home Telemonitoring in Patients With Chronic Heart Failure A Chance to Improve Patient Care? | Silke Schmidt, Prof. Dr. phil.,*,1 Andreas Schuchert, Prof. Dr. med.,2 Thomas Krieg, Dipl-Psych.,1 and Michael Oeff, Prof. Dr. med.3 | Health Affairs | 2018 | 26 | It is critical that future studies deliberately test all essential intervention elements, such as intervention duration and the moderating effect of home care. Researchers, clinicians, and policy makers must not assume that, with HTM, decreased mortality is necessarily associated with decreased utilization. With HTM, early recognition of exacerbation can be promptly resolved at home, whereas a patient who may have delayed or more serious symptom recognition can be managed successfully in the ED. Either way, the result is decreased mortality. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2840250/ | patient reported outcomes implantable cardiac defibrillator | review | n/a | n, follow-up period | |||||||||||
15 | Cardiology | ICD | Outcome Based Comparison | 14 | Clinical Characteristics and Outcome of Infective Endocarditis Involving Implantable Cardiac Devices | Eugene Athan , MD; Vivian H. Chu, MD, MHS; Pierre Tattevin, MD, PhD; Christine Selton-Suty, MD; Phillip Jones, MD; Christoph Naber, MD, PhD; José M. Miró, MD, PhD; Salvador Ninot, MD; Nuria Fernández-Hidalgo, MD; Emanuele Durante-Mangoni, MD; Denis Spelman, MD; Bruno Hoen, MD, PhD; Tatjana Lejko-Zupanc, MD, PhD; Enrico Cecchi, MD; Franck Thuny, MD; Margaret M. Hannan, MD; Paul Pappas, MS; Margaret Henry, PhD, BSc (Hons); Vance G. Fowler, MD, MHS; Anna Lisa Crowley, MD, MHS; Andrew Wang, MD; for the ICE-PCS Investigators | JAMA | 2012 | 2760 | Among patients with CDIE, the rate of concomitant valve infection is high, as is mortality, particularly if there is valve involvement. Early device removal is associated with improved survival at 1 year. | https://jamanetwork.com/journals/jama/article-abstract/1148195 | patient reported outcomes implantable cardiac defibrillator | mortality | no | n, age | |||||||||||
16 | Cardiology | ICD | Outcome Based Comparison | 15 | Implantable Cardiac Device Procedures in Older PatientsUse and In-Hospital Outcomes | Jason P. Swindle, MPH; Michael W. Rich, MD; Patrick McCann, MD; Thomas E. Burroughs, PhD; Paul J. Hauptman, MD | Arch Intern Med. | 2010 | 26887 | Despite the fact that most device trials have excluded patients 80 years or older, more than one-fifth of ICD and CRT devices are implanted in this age group. Advanced age is an independent predictor of in-hospital mortality following device implantation, suggesting that additional study is needed to define criteria for appropriate device use in older patients. | https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/225338 | patient reported outcomes implantable cardiac defibrillator | mortality | no | n, age | |||||||||||
17 | Cardiology | ICD | Outcome Based Comparison | 16 | Implantable cardioverter-defibrillator prescription in the elderly | Andrew E.EpsteinMD, FHRS⁎G. NealKayMD⁎Vance J.PlumbMD⁎H. ThomasMcElderryMD⁎HarishDoppalapudiMD⁎TakumiYamadaMD⁎JeffShafiroffPhD†Zaffer A.SyedMS†SergioShkurovichPhD†ACT Investigators | Heart Rythm Journal | 2009 | 4566 | More than 40% of new ICDs and CRT-Ds are implanted in patients >70 years old and more than 10% in patients >or=80 years old. A significant proportion of those receiving a CRT-D did not fulfill accepted criteria for implantation. Noncardiac death occurred more frequently in older patients, but cardiac death rates were similar. | https://www.sciencedirect.com/science/article/abs/pii/S154752710900407X | patient reported outcomes implantable cardiac defibrillator | no outcome | St Jude Medical | n, age | |||||||||||
18 | Cardiology | ICD | Outcome Based Comparison | 17 | Remote Monitoring of Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Clinical Outcomes | Nirmalatiban Parthiban , Adrian Esterman , Rajiv Mahajan , Darragh J. Twomey , Rajeev K. Pathak , Dennis H. Lau , Kurt C. Roberts-Thomson , Glenn D. Young , Prashanthan Sanders , and Anand N. Ganesan | Journal of the American College of Cardiology | 2015 | 6469 | Meta-analysis of RCTs demonstrates that RM and IO follow-up showed comparable overall outcomes related to patient safety and survival, with a potential survival benefit in RCTs using daily transmission verification. RM benefits include more rapid clinical event detection and a reduction in inappropriate shocks. | https://www.jacc.org/doi/abs/10.1016/j.jacc.2015.04.029 | patient reported outcomes implantable cardiac defibrillator | review and meta analysis | n | n/a | |||||||||||
19 | Cardiology | ICD | Outcome Based Comparison | 18 | Management and Outcome of Permanent Pacemaker and Implantable Cardioverter-Defibrillator Infections | Muhammad R. Sohail , Daniel Z. Uslan , Akbar H. Khan , Paul A. Friedman , David L. Hayes , Walter R. Wilson , James M. Steckelberg , Sarah Stoner , and Larry M. Baddour | Journal of the American College of Cardiology | 2007 | 189 | Cure of CDI is achievable in the large majority of patients treated with an aggressive approach of combined antimicrobial treatment and complete device removal. Based on findings of our large retrospective institutional survey and previously published data, we submit proposed management guidelines of CDI. | https://www.jacc.org/doi/abs/10.1016/j.jacc.2007.01.072 | patient reported outcomes implantable cardiac defibrillator | infections | no | n, age | |||||||||||
20 | Cardiology | ICD | Outcome Based Comparison | 29 | Microvolt T-Wave Alternans Distinguishes Between Patients Likely and Patients Not Likely to Benefit From Implanted Cardiac Defibrillator Therapy | Daniel M. Bloomfield , Richard C. Steinman , Pearila B. Namerow , Michael Parides , Jorge Davidenko , Elizabeth S. Kaufman , Timothy Shinn , Anne Curtis , John Fontaine , Douglas Holmes , Andrea Russo , Chuen Tang and J. Thomas BiggerJr | Circulation | 2004 | n/a | Compared with QRS duration, an abnormal MTWA test is a stronger predictor of death in patients with ischemic heart disease and left ventricular dysfunction who fit MADIT II criteria. More importantly, MTWA can better identify a group of patients not likely to benefit from ICD therapy. | https://www.ahajournals.org/doi/full/10.1161/01.CIR.0000143160.14610.53 | patient reported outcomes implantable cardiac defibrillator | mortality | no | follow-up | |||||||||||
21 | Cardiology | ICD | Outcome Based Comparison | 20 | Sexual concerns and educational needs after an implantable cardioverter defibrillator | Elaine E.SteinkePhD, RNaKathyGill-HoppleRN, MSNbDaraValdezRN, BSNbMarilynWoosterRN, BSNc | Heart & Lung: The Journal of Cardiopulmonary and acute care | 2005 | 12 | Themes identified were (1) anxiety and apprehension, with subthemes of partner overprotectiveness and fear of ICD discharge with sexual activity; (2) varying interest and pattern of sexual activity; (3) powerfulness of ICD discharge; and (4) a need for information and sexual counseling. | https://www.sciencedirect.com/science/article/pii/S0147956305000373?casa_token=la06wtKRoOIAAAAA:JbbsE49iR3tpK6_IwsFsNr3hxNsLEaXBb61kS0HAsdGkqxUxXJgMMvo-NYJsSDHg3u2RtEgq_Uo | patient reported outcomes implantable cardiac defibrillator | psychological | no | n, sex, age | |||||||||||
22 | Cardiology | ICD | Outcome Based Comparison | 21 | Efficacy and safety of implantable cardiac defibrillators for treatment of ventricular arrhythmias in patients with cardiac sarcoidosis | Jordana Kron, William Sauer, Joseph Schuller, Frank Bogun, Thomas Crawford, Sinan Sarsam, Lynda Rosenfeld, Teferi Y. Mitiku, Joshua M. Cooper, Davendra Mehta, Arnold J. Greenspon, Matthew Ortman, David B. Delurgio, Ravinder Valadri, Calambur Narasimhan, Nalla Swapna, Jagmeet P. Singh, Stephan Danik, Steven M. Markowitz, Adrian K. Almquist, Andrew D. Krahn, Luke G. Wolfe, Shawn Feinstein, Kenneth A. Ellenbogen | EP Europace | 2013 | 235 | Patients with CS and ICDs are at high risk for ventricular arrhythmias. This population also has high rates of inappropriate shocks and device complications. | https://academic.oup.com/europace/article/15/3/347/432687?login=true | patient reported outcomes implantable cardiac defibrillator | safety | no | n, age, follow up | |||||||||||
23 | Cardiology | ICD | Outcome Based Comparison | 22 | Effect of remote monitoring on clinical outcomes in European heart failure patients with an implantable cardioverter-defibrillator: secondary results of the REMOTE-CIED randomized trial | Cheyenne S L Chiu, Ivy Timmermans, Henneke Versteeg, Edgar Zitron, Philippe Mabo, Susanne S Pedersen, Mathias Meine, for the REMOTE-CIED Trial Investigators | EP Europace | 2021 | 595 | RPM is non-inferior to conventional In-Clinic visits regarding clinical outcomes. Routine In-Clinic follow-up may partly be substituted by RPM without jeopardizing safety and efficiency, and thus reducing unnecessary In-Clinic visits. | https://academic.oup.com/europace/article/24/2/256/6354873?login=true | patient reported outcomes implantable cardiac defibrillator | mortality | compatible with Boston Scientific Latitude | n, follow-up period | |||||||||||
24 | Cardiology | ICD | Outcome Based Comparison | 23 | Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry | Pier D. Lambiase, Craig Barr, Dominic A.M.J. Theuns, Reinoud Knops, Petr Neuzil, Jens Brock Johansen, Margaret Hood, Susanne Pedersen, Stefan Kääb, Francis Murgatroyd, Helen L. Reeve, Nathan Carter, Lucas Boersma, on behalf of the EFFORTLESS Investigators, P. Adragão, S. Agarwal, C. Barr, L. Boersma, J. Brock-Johanssen, C. Butter, L. Calò, L. Eckhardt, M. Gulizia, M. Scholten, L. Dekker, R. Khiani, S. Hjortshot, H. Høgh Petersen, M. Hood, S. Kääb, R. Knops, J. Kuschyk, P. Lambiase, K. A. Maass, K. McLeod, G. Molon, J. Morgan, P. Mortensen, F. Murgatroyd, P. Neuzil, C. Pepper, P. Sheridan, C. Stellbrink, G. Stuart, D. Theuns, K. Vernooy, C. Veltmann, C. Wende | European Heart Journal | 2014 | 472 | The first large cohort of real-world data from an International patient S-ICD population demonstrates appropriate system performance with clinical event rates and inappropriate shock rates comparable with those reported for conventional ICDs. | https://academic.oup.com/eurheartj/article/35/25/1657/2480979?login=true | patient reported outcomes implantable cardiac defibrillator | technical | no | n, age, follow up | |||||||||||
25 | Cardiology | ICD | Outcome Based Comparison | 24 | Characteristics and Outcomes of Peripartum Versus Nonperipartum Cardiomyopathy in Women Using a Wearable Cardiac Defibrillator | Mitchell T.SaltzbergMD1StevenSzymkiewiczMD2Nicole R.BiancoPhD2 | Journal of Cardiac Failure | 2012 | 266 | The mortality rate of 2.8% (over 3.0 ± 1.2 years) in PPCM patients is low compared to published data. The role of WCD therapy among PPCM patients deserves further study. | https://www.sciencedirect.com/science/article/pii/S1071916411011432?casa_token=X3CbgJRyC0wAAAAA:lN_NwOlfvR3_ba4HHydbPhRNjEPQBAQvfh77fzjLSnbQrg60CvAHcaO8lAH2mhgtSj7Ff4mMB5U | patient reported outcomes implantable cardiac defibrillator | mortality | no | n, age | |||||||||||
26 | Cardiology | ICD | Outcome Based Comparison | 25 | Evaluation of Early Complications Related to De Novo Cardioverter Defibrillator Implantation: Insights From the Ontario ICD Database | Douglas S. Lee , Andrew D. Krahn , Jeffrey S. Healey , David Birnie , Eugene Crystal , Paul Dorian , Christopher S. Simpson , Yaariv Khaykin , Douglas Cameron , Amir Janmohamed , Raymond Yee , Peter C. Austin , Zhongliang Chen , Judy Hardy , Jack V. Tu , and and Investigators of the Ontario ICD Database | Journal of the American College of Cardiology | 2010 | 3340 | Complications after de novo defibrillator implantation were strongly associated with device type. Major complications were associated with increased risk of mortality. | https://www.jacc.org/doi/full/10.1016/j.jacc.2009.11.029 | patient reported outcomes implantable cardiac defibrillator | mortality | yes | n, age, follow up | |||||||||||
27 | Cardiology | ICD | Outcome Based Comparison | 26 | Characteristics and Outcomes of Patients Receiving New and Replacement Implantable Cardioverter-Defibrillators | Daniel B. Kramer , Kevin F. Kennedy , Peter A. Noseworthy , Alfred E. Buxton , Mark E. Josephson , Sharon-Lise Normand , John A. Spertus , Peter J. Zimetbaum , Matthew R. Reynolds and Susan L. Mitchell | Circulation: Cardiovascular Quality and Outcomes | 2013 | 463978 | Patients receiving replacement ICDs are older and at greater risk for death compared with those receiving initial ICD implants. The battery life of initial ICDs is shorter than previously reported. | https://www.ahajournals.org/doi/full/10.1161/CIRCOUTCOMES.111.000054 | patient reported outcomes implantable cardiac defibrillator | mortality | boston scientific | n, age | |||||||||||
28 | Cardiology | ICD | Outcome Based Comparison | 27 | Do Positive Health Expectations and Optimism Relate to Quality-of-Life Outcomes for the Patient With an Implantable Cardioverter Defibrillator? | Sears, Samuel F. PhD; Serber, Eva R. MA; Lewis, Tara Saia PhD; Walker, Robyn L. MS; Conners, Nancy RN; Lee, John T. MD; Curtis, Anne B. MD; Conti, Jamie B. MD | CARDIAC REHABILITATON: BRIEF REPORT | 2004 | 88 | Positive health expectations and optimism are differentially related to various components of QOL. Collectively, these two resilience factors may be targeted in future studies of interventions to improve QOL for ICD patients. | https://journals.lww.com/jcrjournal/Fulltext/2004/09000/Do_Positive_Health_Expectations_and_Optimism.8.aspx?casa_token=kJX9aaRAtCEAAAAA:WO47UsK4-YBovPNa6t-tk76gAYiNJNXouXfh3kgN7lkgpSpnZhVP9G-VL4JGvAmrYbfa3mtA9s3JF3CjZ4Es27msPSBriA | patient reported outcomes implantable cardiac defibrillator | QoL, psychological | no | n, age follow up period | |||||||||||
29 | Cardiology | ICD | Outcome Based Comparison | 28 | Comprehensive cardiac rehabilitation programme for implantable cardioverter-defibrillator patients: a randomised controlled trial | A Fitchet1, P J Doherty2, C Bundy3, W Bell1, A P Fitzpatrick1, C J Garratt1 | Cardiovascular medicine | 2003 | 16 | CCR appears to be safe for patients with ICDs. It can improve exercising ability and lower the levels of psychological distress. A larger multicentre study is recommended to confirm these findings. | https://heart.bmj.com/content/89/2/155.abstract?casa_token=Gx4Rvhtrb-QAAAAA:h1MTfxIbVfpPlV24ZZt4uKH7JcDsj1VCwPCmos0_YJ1ja2hA1b_BIuhVVsYZJ9gLMtWMkgSWLttj | patient reported outcomes implantable cardiac defibrillator | psychological | no | n, sex, age, follow-up | |||||||||||
30 | Cardiology | ICD | Outcome Based Comparison | 29 | Individual patient data network meta-analysis of mortality effects of implantable cardiac devices | B Woods1,2, N Hawkins2,3, S Mealing2, A Sutton4, W T Abraham5, J F Beshai6, H Klein7, M Sculpher1,2, C J Plummer8, M R Cowie9 | Heart failure and cardiomyopathies | 2015 | 12638 | These data provide estimates for the mortality benefits of device therapy conditional upon multiple patient characteristics. They can be used to estimate an individual patient's expected relative benefit and thus inform shared decision making. Clinical guidelines should discuss age and gender as predictors of device benefits. | https://heart.bmj.com/content/101/22/1800.short | patient reported outcomes implantable cardiac defibrillator | mortality | no | n | |||||||||||
31 | Cardiology | ICD | Outcome Based Comparison | 30 | Psychosocial Considerations for Children and Young Adolescents with Implantable Cardioverter Defibrillators: An Update | SAMUEL F. SEARS Ph.D., JAY B. ST. AMANT B.S., VICKI ZEIGLER Ph.D., R.N. | Pacing and Clinical Electrophysiology | 2009 | n/a | Additional research and clinical attention is warranted to further assist young ICD patients to achieve desirable quality of life outcomes. | https://onlinelibrary.wiley.com/doi/full/10.1111/j.1540-8159.2009.02391.x | patient reported outcomes implantable cardiac defibrillator | review | n/A | n/a | |||||||||||
32 | Cardiology | ICD | Outcome Based Comparison | 31 | Posttraumatic Stress and the Implantable Cardioverter-Defibrillator Patient | Samuel F. Sears , Jessica D. Hauf , Kari Kirian , Garrett Hazelton and Jamie B. Conti | Circulation: Arrhythmia and Electrophysiology | 2011 | n/a | Current available research suggests that approximately 20% of patients with ICDs have PTSD. Increased attention to PTSD is a relatively new development to the broader findings of psychosocial research with ICD patients, suggesting a point prevalence of 13% to 38% for anxiety across studies and 10% to 41% for depressive symptoms. Current treatment research for ICD patients focuses on the prophylaxis of distress (through education and medication management) and the treatment of anxiety and depression. Our review indicates that electrophysiologists “need to know” how to develop a screen and refer plan for patients with PTSD symptoms. Mounting evidence suggests that PTSD symptomatology is highly prevalent in electrophysiology clinics and detrimental to psychosocial and physical health end points. | https://www.ahajournals.org/doi/full/10.1161/CIRCEP.110.957670 | patient reported outcomes implantable cardiac defibrillator | case-study | no | n/a | |||||||||||
33 | Cardiology | ICD | Outcome Based Comparison | 32 | Implant and Midterm Outcomes of the Subcutaneous Implantable Cardioverter-Defibrillator Registry: The EFFORTLESS Study | Lucas Boersma , Craig Barr , Reinoud Knops , Dominic Theuns , Lars Eckardt , Petr Neuzil , Marcoen Scholten , Margaret Hood , Juergen Kuschyk , Paul Jones , Elizabeth Duffy , Michael Husby , Kenneth Stein , Pier D. Lambiase , and on behalf of the EFFORTLESS Investigator Group | Journal of the American College of Cardiology | 2017 | 82 | This registry demonstrates that the S-ICD fulfills predefined endpoints for safety and efficacy. Midterm performance rates on complications, inappropriate shocks, and conversion efficacy were comparable to rates observed in transvenous implantable cardioverter-defibrillator studies. (Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD | https://www.jacc.org/doi/abs/10.1016/j.jacc.2017.06.040 | patient reported outcomes implantable cardiac defibrillator | safety | no | n, follow-up period | |||||||||||
34 | Cardiology | ICD | Outcome Based Comparison | 33 | Outcomes of Implantable Cardioverter-Defibrillator Use in Patients With Comorbidities: Results From a Combined Analysis of 4 Randomized Clinical Trials | Benjamin A. Steinberg , Sana M. Al-Khatib , Rex Edwards , JooYoon Han , Gust H. Bardy , J. Thomas Bigger , Alfred E. Buxton , Arthur J. Moss , Kerry L. Lee , Richard Steinman , Paul Dorian , Alfred Hallstrom , Riccardo Cappato , Alan H. Kadish , Peter J. Kudenchuk , Daniel B. Mark , Lurdes Y.T. Inoue , and Gillian D. Sanders | Journal of the American College of Cardiology | 2014 | 3348 | Patients with extensive comorbid medical illnesses may experience less benefit from primary prevention ICDs than those with less comorbidity; implantation should be carefully considered in sick patients. Further study of ICDs in medically complex patients is warranted. | https://www.jacc.org/doi/abs/10.1016/j.jchf.2014.06.007 | patient reported outcomes implantable cardiac defibrillator | mortality | no | n | |||||||||||
35 | Cardiology | ICD | Outcome Based Comparison | 34 | Predictors of Quality of Life in Patients With Implantable Cardioverter Defibrillators | Samuel F.SearsPh.D.Tara SaiaLewisPh.D.Emily A.KuhlM.A.Jamie B.ContiM.D. | Psychosomatics | 2005 | 88 | The impact of psychological maladjustment on quality of life is clear, and, despite methodological weaknesses, the influence of ICD shocks cannot be discounted.13,14,34 Given the wealth of data identifying factors associated with quality of life outcomes, future psychological research should focus on the impact of psychosocial interventions. Further research is also needed to more specifically address the independent value of each of the psychological predictor variables by determining the differential risk associated with each of these factors. The ICD represents a great innovation in decreasing mortality of sudden cardiac death. These data emphasize the importance of a biopsychosocial model in understanding the quality of life outcomes for ICD patients. | https://www.sciencedirect.com/science/article/pii/S0033318205700578?casa_token=BQokoMm4wJ4AAAAA:HGDVvTJBjLNTth6_cQbCMR5t9TLVIjPu3XpJshIo4ABYLX7MDRfiEgvRY2tQ9wfXTY6gQNAMK8U | patient reported outcomes implantable cardiac defibrillator | QoL | no | n, follow-up period | |||||||||||
36 | Cardiology | ICD | Outcome Based Comparison | 35 | Undertreatment of anxiety and depression in patients with an implantable cardioverter-defibrillator: Impact on health status. | Hoogwegt, Madelein T. Kupper, Nina Theuns, Dominic A. M. J. Zijlstra, Wobbe P. Jordaens, LucPedersen, Susanne S. | Health Psychology | 2012 | 448 | There was a serious gap between the need for psychological treatment and the actual delivery of treatment, with consequences to patients' health status. Detection and adequate treatment of distress in ICD patients remains an important target in this patient group in order to safeguard health status postimplantation. (PsycINFO Database Record (c) 2012 APA, all rights reserved). | https://psycnet.apa.org/record/2012-10743-001 | patient reported outcomes implantable cardiac defibrillator | psychological | no | n, age, gender, follow-up | |||||||||||
37 | Cardiology | ICD | Outcome Based Comparison | 36 | 16-Year Trends in the Infection Burden for Pacemakers and Implantable Cardioverter-Defibrillators in the United States: 1993 to 2008 | Arnold J. Greenspon , Jasmine D. Patel , Edmund Lau , Jorge A. Ochoa , Daniel R. Frisch , Reginald T. Ho , Behzad B. Pavri , and Steven M. Kurtz | Heart Rythm Disorder | 2011 | n/a | The infection burden associated with CIED implantation is increasing over time and is associated with prolonged hospital stays and high financial costs. | https://www.jacc.org/doi/full/10.1016/j.jacc.2011.04.033 | patient reported outcomes implantable cardiac defibrillator | infections | no | n/a | |||||||||||
38 | Cardiology | ICD | Outcome Based Comparison | 37 | Outcome and Complications After Implantable Cardioverter Defibrillator Therapy in Hypertrophic Cardiomyopathy | Arend F.L. Schinkel , Pieter A. Vriesendorp , Eric J.G. Sijbrands , Luc J.L.M. Jordaens , Folkert J. ten Cate and Michelle Michels | Circulation: Heart Failure | 2012 | 2190 | This meta-analysis demonstrates a low cardiac and noncardiac mortality rate after ICD therapy in patients with hypertrophic cardiomyopathy. Appropriate ICD intervention occurred at a rate of 3.3%/year, thereby, most probably, preventing SCD. Inappropriate ICD intervention and complications are not uncommon. | https://www.ahajournals.org/doi/full/10.1161/CIRCHEARTFAILURE.112.969626 | patient reported outcomes implantable cardiac defibrillator | review | n/a | n, age, gender | |||||||||||
39 | Cardiology | ICD | Outcome Based Comparison | 38 | Costs and Quality-of-Life Effects of Implantable Cardioverter-Defibrillators | Peter W.GroeneveldMD, MSabcMary AnneMattaMSbJanice J.SuhBSbPaul A.HeidenreichMD, MSdeJudy A.SheaPhDbc | The American Journal of Cardiology | 2006 | 259 | The best published estimates indicate that ICD implantation costs approximately $28,500 to $55,200, and subsequent annual ICD-related follow-up costs range from $4,800 to $17,000. Although insufficient data exist to confirm a time trend in ICD costs, it is plausible that current costs are in the lower half of these ranges. The published research also suggests that QOL of ICD recipients is better than QOL of patients taking antiarrhythmic drugs, but ICD recipients’ QOL is not as high as that of the general public or of recipients of more “benign” cardiac devices, such as pace- makers. Concerns about ICD shocks and the negative ef- fects of ICDs on patients’ sense of control, social interac- tions, driving, sexuality, capacity to work, and ability to engage in leisure activities appear to adversely influence ICD recipients’ perceptions of health and well-being. | https://www.sciencedirect.com/science/article/pii/S000291490601530X?casa_token=tHmQqCdVHCYAAAAA:a2oS0M2wapxZi6Ntm0mUeWN_QA59hj-sa-KncrZZlnxOOrI6eXehuYDvJH39j5yp-_axsngzxY4 | patient reported outcomes implantable cardiac defibrillator | review | no | n/a | |||||||||||
40 | Cardiology | ICD | Outcome Based Comparison | 39 | Cardiac Resynchronization and Quality of Life in Patients With Minimally Symptomatic Heart Failure | Peter J. Veazie , Katia Noyes , Qinghua Li , W. Jackson Hall , April Buttaccio , Kelly Thevenet-Morrison , and Arthur J. Moss | Journal of the American College of Cardiology | 2012 | 1820 | Compared with patients with ICD only, CRT-ICD is associated with greater improvement in QOL among relatively asymptomatic patients, specifically among those with left bundle branch conduction disturbance. | https://www.jacc.org/doi/abs/10.1016/j.jacc.2012.06.054 | patient reported outcomes implantable cardiac defibrillator | QoL | no (but funded by Boston Scientific) | n, follow-up period | |||||||||||
41 | Cardiology | ICD | Outcome Based Comparison | 40 | A brief cognitive behavioural preimplantation and rehabilitation programme for patients receiving an implantable cardioverter-defibrillator improves physical health and reduces psychological morbidity and unplanned readmissions | R J Lewin1, S Coulton2, D J Frizelle3, G Kaye4, H Cox5 | Heart rhythm disorders and pacemakers | 2009 | 192 | The ICD Plan improved health-related quality of life, reduced the incidence of clinically significant psychological distress and significantly reduced unplanned readmissions. It is a cost effective and easily implemented method for delivering rehabilitation and psychological care to patients undergoing ICD implantation. | https://heart.bmj.com/content/95/1/63.abstract?casa_token=PSZmTgw3guwAAAAA:Z1IhuxxWXnEKuq6JJogR4p4oQ0joGlxdCnj96gSbB9noY2RoHNTbwQeZCwsblpOgjDgGCZCz2CP- | patient reported outcomes implantable cardiac defibrillator | psychological, QoL | no | n, follow-up period | |||||||||||
42 | Cardiology | ICD | Outcome Based Comparison | 41 | How to Respond to an Implantable Cardioverter-Defibrillator Shock | Samuel F. SearsJr , Julie B. Shea and Jamie B. Conti | Circulation | 2005 | n/a | Experiencing an ICD shock can be an unwelcome reminder about your heart condition. However, the ICD remains the best treatment option to keep you safe from cardiac arrhythmias. Desirable quality of life can also be achieved despite the experience of shock. Collectively, you, your family and significant others, and your healthcare team can plan for shock, engage in preshock and postshock coping strategies, and resume a desirable quality of life. | https://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.104.508663 | patient reported outcomes implantable cardiac defibrillator | commentary | no | n/a | |||||||||||
43 | Cardiology | ICD | Outcome Based Comparison | 42 | Applicability of a Risk Score for Prediction of the Long-Term (8-Year) Benefit of the Implantable Cardioverter-Defibrillator | Alon Barsheshet , Arthur J. Moss , David T. Huang , Scott McNitt , Wojciech Zareba , and Ilan Goldenberg | Journal of the American College of Cardiology | 2012 | 991 | These findings suggest that a simple risk score can identify patients who derive significant long-term benefit from primary ICD therapy. High-risk patients with multiple comorbidities composed 17% of the MADIT-II population and did not derive long-term benefit from nonresynchronization device therapy. | https://www.jacc.org/doi/abs/10.1016/j.jacc.2012.02.036 | patient reported outcomes implantable cardiac defibrillator | safety | no | follow-up | |||||||||||
44 | Cardiology | ICD | Outcome Based Comparison | 43 | Gender and outcomes after primary prevention implantable cardioverter-defibrillator implantation: Findings from the National Cardiovascular Data Registry (NCDR) | Andrea M.RussoMDaStacie L.DaughertyMD, MSPHbFrederick A.MasoudiMD, MSPHbYongfeiWangMScJepthaCurtisMDcRachelLampertMDc | American Heart Journal | 2015 | 38912 | Among older patients receiving ICDs for primary prevention in clinical practice, women experience worse outcomes than do men. Reasons for gender differences in outcomes are poorly understood and require further investigation. | https://www.sciencedirect.com/science/article/pii/S0002870315002379?casa_token=wzh9Bcx23XAAAAAA:l1UQAhOB0Pd_RNvYz_XU1yDbr8KgmZL-oAYc0jxWmc8HTUQfjN-qVsRTZAMzWBA676K10HAdrt0 | patient reported outcomes implantable cardiac defibrillator | mortality | no | n | |||||||||||
45 | Cardiology | ICD | Outcome Based Comparison | 44 | Living with an implantable cardioverter defibrillator: The patients' experience | Nina K.HumphreysPhDaRobLowePhDaJaynieRancePhDbPaul D.BennettPhD, RNa | Heart & Lung: The Journal of Cardiopulmonary and acute care | 2016 | 18 | ICD recipients might be helped by a psycho-social intervention that corrects false beliefs about exercise and offers some simple stress management techniques. Additional elements might include helping recipients to re-evaluate goals and find a valued sense of self which this study found aided ICD acceptance. | https://www.sciencedirect.com/science/article/pii/S0147956315002691?casa_token=U6CrrGMyV8gAAAAA:mHYAqpjV7x1CYNN0mZYL9CC-BYtrrwRLyIjEuynlqFZaf2jOv0qSbaxmA_rbKEdhXrgcMc--QdM | patient reported outcomes implantable cardiac defibrillator | psychological | no | n | |||||||||||
46 | Cardiology | ICD | Outcome Based Comparison | 45 | Implantable cardioverter defibrillator recipients: quality of life in recipients with and without ICD shock delivery: A prospective study | H. C. M. Kamphuis, J. R. J. de Leeuw, R. Derksen, R. N. W. Hauer, J. A. M. Winnubst | Europace | 2003 | 167 | Overall quality of life and psychological well-being did not change in ICD recipients, irrespective of whether they experienced defibrillatory shocks. The high prevalence of depression and anxiety can be interpreted as a response to the perceived physical and mental problems regarding daily activities. Our data indicate that patients who have experienced an ICD shock do not adapt well to living with an ICD, they are more anxious than ICD recipients who received no shocks. However, the anticipation of having another shock after experiencing one is less stressful than that of the first shock. We conclude that the lasting psychological distress will not dissipate spontaneously or naturally and that psychosocial interventions may be warranted. | https://academic.oup.com/europace/article/5/4/381/551389?login=true | patient reported outcomes implantable cardiac defibrillator | psychological, QoL | no | n, follow-up period | |||||||||||
47 | Cardiology | ICD | Outcome Based Comparison | 46 | The Relation Between Patients’ Outcomes and the Volume of Cardioverter-Defibrillator Implantation Procedures Performed by Physicians Treating Medicare Beneficiaries | Sana M. Al-Khatib , F. Lee Lucas , James G. Jollis , David J. Malenka , and David E. Wennberg | Journal of the American College of Cardiology | 2005 | n/a | We observed an association between a higher volume of ICD implants and a lower rate of mechanical complications and infections. This association suggests that ICD implantation should not be performed by physicians without regard to their procedural volume. | https://www.jacc.org/doi/abs/10.1016/j.jacc.2005.04.063 | patient reported outcomes implantable cardiac defibrillator | psychological, QoL | no but study funded by Medtronic and Guidant | follow-up | |||||||||||
48 | Cardiology | ICD | Outcome Based Comparison | 47 | A Systematic Review and Meta-analysis of the Association Between Implantable Cardioverter-Defibrillator Shocks and Long-term Mortality | RiccardoProiettiMD, PhDabChristopherLabosMD, CM, MScaMarkDavisMDaGeorgeThanassoulisMD, MScaPasqualeSantangeliMDcVincenzoRussoMDdLuigiDi BiaseMD, PhDefJean-FrancoisRouxMDagAtulVermaMDahAndreaNataleMDeijkVidalEssebagMD, PhDal | Canadian Journal of Cardiology | 2015 | n/a | Our analysis showed a significant association between appropriate and inappropriate ICD shocks and mortality, with a stronger association for appropriate shocks. Previous trials of ICD therapy reduction programming have shown a significant reduction of inappropriate shocks. The management of appropriate shocks is more challenging and may be optimized by the assessment and treatment of the underlying ventricular arrhythmias. The role of therapies aimed at modifying the arrhythmic substrate and the potential impact on ICD shocks and mortality requires further investigation. | https://www.sciencedirect.com/science/article/pii/S0828282X14016122?casa_token=tUGbcdK9kEgAAAAA:AqnYbxg3ySCxs1rpaaWiHO-_32vgH83dqmzqZtli0tPvL1Lf3wpTLe5_2NTSXfH2r6QImHxPi_w | patient reported outcomes implantable cardiac defibrillator | review | n/a | n/a | |||||||||||
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