Johnson / Virgo The Bionic Human

Health Promotion for People with Implanted Prosthetic Devices
1. Auflage 2007
ISBN: 978-1-59259-975-2
Verlag: Humana Press
Format: PDF
Kopierschutz: 1 - PDF Watermark

E-Book, Englisch, 706 Seiten

An integrated survey of best practices for the management of patients with implanted prosthetic devices and an insightful examination of the epidemiological, societal, and policy issues associated with their use. The devices covered range from breast, penile, vascular, and joint prostheses to cochlear, ossicular, and dental implants, and include cerebrospinal fluid shunts, cardiac valves, stents, and pacemakers. For each device, the authors consider its pros and cons, detail the best current strategies to keep implanted patients healthy, and evaluate the latest and most promising new diagnostic tests, Clinical counterpoints from distinguished authorities at major centers in the United States and Europe are offered throughout. Follow-up recommendations are summarized in a standardized format that allows comparative analysis and lays the foundation for controlled clinical trials and the eventual establishment of evidence-based guidelines.

Autoren/Hrsg.

Johnson, Frank E

Virgo, Katherine S.

Inhaltsverzeichnis

1;Foreword;5
2;Preface;6
3;Contents;7
4;Contributors;11
5;Overview;15
5.1;APPENDIX;21
5.2;APPENDIX (Continued);22
5.3;APPENDIX (Continued);23
5.4;APPENDIX (Continued);24
5.5;APPENDIX (Continued);25
5.6;REFERENCES;26
6;Assessment of Surveillance Test Performance and Cost;27
6.1;EPIDEMIOLOGICAL PRINCIPLES FOR EVALUATING DIAGNOSTIC TEST PERFORMANCE IN SCREENING FOR DEVICE MALFUNCTION OR INFECTION Overview;28
6.2;DIAGNOSTIC TEST CHARACTERISTICS Validity;28
6.3;LIKELIHOOD RATIOS;31
6.4;REQUIREMENTS FOR ESTABLISHING A SCREENING PROGRAM;32
6.5;RECEIVER OPERATING CHARACTERISTIC CURVE;32
6.6;THRESHOLDS FOR TREATMENT;33
6.7;THRESHOLDS FOR TESTING;34
6.8;ECONOMIC PRINCIPLES OF FOLLOW-UP EVALUATION Overview of Cost Analysis;36
6.9;SUMMARY;44
6.10;REFERENCES;44
7;Costs of Follow-Up After Implantation of Prosthetic Devices;47
7.1;METHODS;48
7.2;RESULTS;49
7.3;COMMENT;57
7.4;REFERENCES;59
8;Factors That Should Shape Clinical Strategies;60
8.1;ETHICAL AND LEGAL ISSUES;67
8.2;DURATION OF SURVEILLANCE;68
8.3;SECONDARY BENEFITS OF FOLLOW-UP;68
8.4;PRIMARY PREVENTION OF DISEASE;68
8.5;SUMMARY;71
8.6;REFERENCES;72
9;A View From the US Food and Drug Administration*;74
9.1;INTRODUCTION;74
9.2;PREMARKET REVIEW Background;76
9.3;POSTMARKET OVERSIGHT Overview;86
9.4;SPECIAL TOPICS Access to Information;95
9.5;REFERENCES;98
10;Societal Issues;101
10.1;TECHNOLOGY AND SOCIETY;101
10.2;TECHNOLOGY AND HISTORY;101
10.3;COSTS;102
10.4;MANAGED CARE;103
10.5;IMPLANTED TECHNOLOGY;104
10.6;BREAST IMPLANTS Background;104
10.7;THE BJORK-SHILEY CONVEXO-CONCAVE ARTIFICIAL HEART VALVE Background;108
10.8;COCHLEAR IMPLANTS (40)* Background;118
10.9;THE TOTAL ARTIFICIAL HEART Background;120
10.10;SOCIETAL ISSUES IN IMPLANTED MEDICAL DEVICES;123
10.11;PROFESSIONAL AND CONSUMER MODELS OF HEALTH CARE;124
10.12;REFERENCES;124
11;Databases for Studying the Epidemiology of Implanted Medical Devices*;127
11.1;INTRODUCTION;127
11.2;SYSTEMATIC NEW DATA COLLECTION;128
11.3;GATHERING AND SYNTHESIS OF EXISTING PATIENT DATA AND STUDIES;131
11.4;FUTURE OF DATABASES FOR STUDYING THE EPIDEMIOLOGY OF IMPLANTED DEVICES Increasing Technological Sophistication of Patient Data;139
11.5;ACKNOWLEDGMENT;140
11.6;REFERENCES;140
12;Tissue Reaction to Prosthetic Materials;145
12.1;INTRODUCTION;145
12.2;MATERIALS USED IN PROSTHESES;146
12.3;MOLECULAR AND CELLULAR EVENTS OF HOMEOSTASIS;154
12.4;HISTOPATHOLOGY OF EXPLANTED PROSTHESES Dental;159
12.5;FUTURE TRENDS IN PROSTHETIC DESIGN;165
12.6;REFERENCES;165
13;Prevention of Infection in Prosthetic Devices;171
13.1;INTRODUCTION;171
13.2;GENERAL PRINCIPLES OF INFECTION PREVENTION IN PROSTHETIC DEVICES Preoperative Measures;173
13.3;INDIVIDUAL CHARACTERISTICS OF THE MOST COMMONLY USED PROSTHETIC DEVICES Breast Implants;176
13.4;SUMMARY;190
13.5;REFERENCES;193
14;European Counterpoint to Chapter 9;198
14.1;INTRODUCTION;198
14.2;THE ROLE OF PROPHYLACTIC ANTIBIOTICS;199
14.3;PATIENT FACTORS THAT CONTRIBUTE TO INFECTION OF PROSTHESES;200
14.4;VENTRICULOPERITONEAL SHUNTS;200
14.5;PENILE PROSTHESIS;202
14.6;JOINT PROSTHESES;204
14.7;MESH REPAIRS OF HERNIAS;206
14.8;VASCULAR GRAFTS;207
14.9;BREAST IMPLANTS;208
14.10;PROSTHETIC CARDIAC VALVES;209
14.11;COCHLEAR IMPLANTS;210
14.12;COMMENTS;212
14.13;REFERENCES;213
15;Computer Modeling;216
15.1;INTRODUCTION;216
15.2;EXAMPLE 1: A DECISION TREE FOR A DIAGNOSTIC PROBLEM;217
15.3;EXAMPLE 2: A STATE-TRANSITION MODEL FOR A PROGNOSTIC PROBLEM;217
15.4;EXAMPLE 3: A MODEL FOR A FOLLOW-UP SCHEME;217
15.5;DECISION TREES;217
15.6;EXAMPLE 1: BREAST IMPLANTS;218
15.7;STATE-TRANSITION MODELS;225
15.8;EXAMPLE 2: BJÖRK-SHILEY CONVEXO- CONCAVE HEART VALVE PATIENTS;229
15.9;EXAMPLE 3: EVALUATION OF FOLLOW-UP SCHEMES;232
15.10;GENERAL MODELING ISSUES;234
15.11;VALIDITY AND CREDIBILITY;235
15.12;SUMMARY AND CONCLUSION;237
15.13;FURTHER READING;238
15.14;REFERENCES;238
16;Breast Prostheses;241
16.1;INTRODUCTION;241
16.2;MAMMOGRAPHY;252
16.3;ULTRASOUND;253
16.4;MAGNETIC RESONANCE IMAGING;253
16.5;COMPUTED TOMOGRAPHY;254
16.6;ENDOSCOPY;254
16.7;CAPSULAR CONTRACTURE;254
16.8;ACKNOWLEDGMENTS;258
16.9;APPENDIX: SUPPORT GROUPS;258
16.10;APPENDIX: SUPPORT GROUPS ( CONTINUED);259
16.11;REFERENCES;259
17;US Counterpoint to Chapter 11;265
17.1;INTRODUCTION;265
17.2;REFERENCES;267
18;European Counterpoint to Chapter 11;269
18.1;USE OF BREAST IMPLANTS IN THE UNITED KINGDOM;269
18.2;BREAST AUGMENTATION;271
18.3;INFECTION AND BREAST IMPLANTS;273
18.4;CAPSULAR CONTRACTURE;274
18.5;APPENDIX: SOURCES OF ADDITIONAL INFORMATION;277
18.6;REFERENCES;278
18.7;APPENDIX: SOURCES OF ADDITIONAL INFORMATION (Continued);278
19;Prostheses for Hernia Repair;280
19.1;INTRODUCTION;280
19.2;PROSTHETIC FAILURE AND INFECTION;283
19.3;PREVENTIVE MEASURES;284
19.4;REFERENCES;284
20;US Counterpoint to Chapter 12;286
20.1;INGUINAL HERNIA REPAIR;286
20.2;INCISIONAL HERNIA REPAIR;288
20.3;OTHER ABDOMINAL WALL HERNIAS;290
20.4;SUMMARY;291
20.5;REFERENCES;291
21;European Counterpoint to Chapter 12;293
21.1;PROSTHESES FOR HERNIA REPAIR;293
21.2;IMPORTANCE OF PROSTHESIS DESIGN AND QUALITY OF MANUFACTURE;294
21.3;PREVENTIVE MEASURES;295
21.4;REFERENCES;295
22;Penile Prostheses;297
22.1;INTRODUCTION;297
22.2;APPENDIX A: ORGANIZATIONS WITH ERECTILE DYSFUNCTION INFORMATION;305
22.3;APPENDIX A: ORGANIZATIONS WITH ERECTILE DYSFUNCTION INFORMATION (Continued);306
22.4;PROSTATE CANCER SURVIVORS GROUPS:;306
22.5;APPENDIX B: VENDORS OF PENILE IMPLANTS IN THE UNITED STATES;306
22.6;REFERENCES;306
23;US Counterpoint to Chapter 13;308
23.1;INTRODUCTION;308
23.2;REFERENCE;309
24;European Counterpoint to Chapter 13;310
24.1;INTRODUCTION;310
24.2;SAFETY AND OUTCOME;311
24.3;INDICATIONS FOR IMPLANTING PENILE PROSTHESES;311
24.4;PROSTHETIC DESIGN/QUALITY OF MANUFACTURE;318
24.5;APPENDIX: SOURCES OF ADDITIONAL IINFORMATION;318
24.6;REFERENCES;319
25;Artificial Urethral Sphincters;321
25.1;INTRODUCTION;321
25.2;PUBLISHED GUIDELINES FOR FOLLOW-UP;323
25.3;DETECTION OF PROSTHETIC FAILURE;324
25.4;DETECTION OF PROGRESSION OF THE DISORDER FOR WHICH THE PROSTHESIS WAS PLACED;324
25.5;DETECTION OF OTHER CONDITIONS OF MEDICAL SIGNIFICANCE;325
25.6;WHAT IS KNOWN ABOUT ACTUAL STRATEGIES OF PRACTICING CLINICIANS?;325
25.7;IMPORTANCE OF PROSTHESIS DESIGN AND QUALITY OF MANUFACTURE;325
25.8;VARIATION IN FOLLOW-UP BY PROSTHETIC TYPE;326
25.9;ARE MULTICENTER PROSPECTIVE TRIALS NEEDED?;327
25.10;APPENDIX: SUPPORT GROUPS FOR PEOPLE WITH CONTINENCE- RELATED PROBLEMS;328
25.11;REFERENCES;328
26;US Counterpoint to Chapter 14;330
26.1;INTRODUCTION;330
26.2;REFERENCE;331
27;European Counterpoint to Chapter 14;332
27.1;FOLLOW-UP;336
27.2;FUTURE RESEARCH;337
27.3;APPENDIX: ADDITIONAL RESOURCES FOR INFORMATION ABOUT ARTIFICIAL URETHRAL SPHINCTERS;338
27.4;REFERENCES;338
28;Cerebrospinal Fluid Shunts;340
28.1;HISTORY;340
28.2;EPIDEMIOLOGY;342
28.3;PATHOPHYSIOLOGY;343
28.4;CSF SHUNT HYDRODYNAMICS;345
28.5;SHUNT COMPONENTS AND DESIGN;347
28.6;OPERATIVE PROCEDURES;351
28.7;FOLLOW-UP CARE;355
28.8;DIAGNOSIS AND TREATMENT OF SHUNT COMPLICATIONS;358
28.9;SUPPORT ORGANIZATIONS;360
28.10;APPENDIX: RECOMMENDED HYDROCEPHALUS SUPPORT ORGANIZATIONS;360
28.11;REFERENCES;361
29;US Counterpoint to Chapter 15;366
29.1;INTRODUCTION;366
29.2;APPENDIX: RESOURCES FOR LEARNING MORE ABOUT HYDROCEPHALUS;368
29.3;REFERENCES;369
30;European Counterpoint to Chapter 15;370
30.1;EPIDEMIOLOGY;370
30.2;EVOLUTION OF CLINICAL PRACTICE;372
30.3;FOLLOW-UP MANAGEMENT;373
30.4;DETECTION AND MANAGEMENT OF SHUNT INFECTION;376
30.5;PRIMARY AND SECONDARY PREVENTION;378
30.6;MULTI-INSTITUTION PROSPECTIVE TRIALS;379
30.7;APPENDIX: SUPPORT GROUPS IN EUROPE;380
30.8;REFERENCES;380
31;Cochlear Implants;386
31.1;HISTORICAL ASPECTS AND TRENDS;386
31.2;COCHLEAR IMPLANT COMPONENTS AND THEIR FUNCTIONS;388
31.3;CURRENTLY AVAILABLE COCHLEAR IMPLANTS IN THE UNITED STATES;389
31.4;MEDEL (MEDICAL ELECTRONICS);394
31.5;PERFORMANCE OF DIFFERENT DEVICES;395
31.6;CANDIDACY, PREOPERATIVE PLANNING, AND SURGERY Indication;396
31.7;IMPORTANCE OF PROSTHETIC DESIGN;398
31.8;FOLLOW-UP CONSIDERATIONS;399
31.9;PROGRAMMING STRATEGIES OF PRACTICING CLINICIANS;400
31.10;SPECIAL PATIENT POPULATIONS;401
31.11;EXPECTATIONS AND RECOVERY STAGES;404
31.12;DELAYED COMPLICATIONS;404
31.13;SUPPORT GROUPS;406
31.14;APPENDIX: CONTACT INFORMATION FOR SUPPORT GROUPS;408
31.15;REFERENCES;409
32;US Counterpoint to Chapter 16;411
32.1;RESPONSIBILITY;411
32.2;EARLY PROBLEM DETECTION;412
32.3;LATE PROBLEM DETECTION;412
32.4;SUMMARY;413
32.5;REFERENCES;414
33;European Counterpoint to Chapter 16;415
33.1;INTRODUCTION;415
33.2;PREOPERATIVE ASSESSMENT;416
33.3;REFERENCES;418
34;Ossicular Implants;420
34.1;INTRODUCTION;420
34.2;BIOMATERIALS;421
34.3;TYPES OF OSSICULAR PROSTHESES;422
34.4;INDICATIONS FOR IMPLANTS;422
34.5;FOLLOW-UP;425
34.6;DETECTION OF COMPLICATIONS;425
34.7;PROSTHESES FOR STAPES SURGERY IN OTOSCLEROSIS;426
34.8;APPENDIX: WEB SITES FOR FURTHER INFORMATION;429
34.9;REFERENCES;429
35;US Counterpoint to Chapter 17;431
35.1;RESPONSIBILITY;431
35.2;EARLY PROBLEM DETECTION;432
35.3;LATE PROBLEM DETECTION;432
35.4;THINGS TO AVOID;433
35.5;SUMMARY;434
35.6;REFERENCES;435
36;European Counterpoint to Chapter 17;436
36.1;RECONSTRUCTIVE MIDDLE EAR SURGERY;436
36.2;POSTOPERATIVE SURVEILLANCE;439
36.3;REFERENCES;441
37;Vascular Prostheses;443
37.1;INTRODUCTION;443
37.2;GENERAL CONSIDERATIONS;443
37.3;CAROTID REVASCULARIZATION;447
37.4;HEMODIALYSIS ACCESS;451
37.5;RENOVASCULAR INTERVENTIONS;453
37.6;MESENTERIC ARTERY REVASCULARIZATION;455
37.7;INTERVENTIONS FOR AORTOILIAC OCCLUSIVE DISEASE;457
37.8;AORTIC ENDOGRAFTS;460
37.9;SURVEILLANCE AFTER PLACEMENT OF AORTIC ENDOGRAFTS;463
37.10;INFRAINGUINAL BYPASS GRAFTS;466
37.11;TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT;470
37.12;SUMMARY;472
37.13;REFERENCES;473
38;US Counterpoint to Chapter 18;479
38.1;INTRODUCTION;479
39;European Counterpoint to Chapter 18;486
39.1;INTRODUCTION;486
39.2;AORTIC AND SUPRAINGUINAL RECONSTRUCTION AND FOLLOW- UP OF ASYMPTOMATIC PATIENTS;488
39.3;INFRAINGUINAL BYPASS AND FOLLOW-UP IN ASYMPTOMATIC PATIENTS;490
39.4;CONCLUSION;492
39.5;REFERENCES;492
40;Cardiac Valves;494
40.1;INTRODUCTION;494
40.2;HISTORY OF HEART VALVE PROSTHESES;495
40.3;CLASSIFICATION OF PROSTHETIC HEART VALVES;496
40.4;MANAGEMENT OF THE PATIENT WITH A PROSTHETIC HEART VALVE;502
40.5;CHRONIC ANTICOAGULATION: THROMBOEMBOLIC RISK AND BLEEDING RISK;508
40.6;PROSTHETIC HEART VALVE DYSFUNCTION;513
40.7;EVALUATION AND TREATMENT OF CORONARY HEART DISEASE IN PATIENTS WITH PROSTHETIC VALVES;522
40.8;APPENDIX: RESOURCES FOR PHYSICIANS AND PATIENTS;523
40.9;REFERENCES;523
41;US Counterpoint to Chapter 19;528
41.1;APPENDIX: RESOURCES FOR PHYSICIANS AND PATIENTS;531
41.2;REFERENCES;531
42;European Counterpoint to Chapter 19;533
42.1;CURRENT PRACTICE;533
42.2;FOLLOW-UP AFTER MECHANICAL HEART VALVE REPLACEMENT;535
42.3;MANAGEMENT OF INFECTIONS AND PREVENTION OF PROSTHETIC VALVE ENDOCARDITIS;535
42.4;MANAGEMENT OF ANTICOAGULANTS;536
42.5;REFERENCES;537
43;Intravascular Filters and Stents;538
43.1;INTRODUCTION;538
43.2;VENA CAVAL FILTERS;538
43.3;ENDOVASCULAR STENTS;542
43.4;REFERENCES;545
44;US Counterpoint to Chapter 20;547
44.1;REFERENCES;550
45;European Counterpoint to Chapter 20;552
45.1;VENOUS STENTS;555
45.2;COMMENT;557
45.3;APPENDIX:;559
45.4;SPECIALIST;559
45.5;ORGANIZATIONS IN INTERVENTIONAL;559
45.6;RADIOLOGY;559
45.7;REFERENCES;561
46;Vascular Access Devices;565
46.1;HISTORY;565
46.2;SHORT-TERM, PERCUTANEOUS, NON- TUNNELED CENTRAL VENOUS CATHETERS;566
46.3;INTERMEDIATE-TERM CENTRAL VENOUS ACCESS DEVICES;568
46.4;LONG-TERM, SILASTIC, TUNNELED, CUFFED RIGHT ATRIAL CATHETERS;569
46.5;LONG-TERM SUBCUTANEOUS VENOUS ACCESS PORTS;569
46.6;IMPLANTABLE INFUSION PUMPS;573
46.7;CVC MAINTENANCE AND SURVEILLANCE FOR COMPLICATIONS;573
46.8;SURVEY OF OHIO SURGEONS WHO IMPLANT VENOUS ACCESS DEVICES;576
46.9;CVC SURVEILLANCE: CONTROVERSIES AND POTENTIAL FUTURE STUDIES Catheter- Associated Infection;581
46.9.1;Catheter Occlusion;583
46.9.2;Catheter Damage/Breakage;584
46.9.3;Venous Thrombosis and Stenosis;584
46.10;CONCLUSION;587
46.11;REFERENCES;587
47;US Counterpoint to Chapter 21;592
47.1;VASCULAR ACCESS DEVICES;592
47.2;REFERENCES;595
48;European Counterpoint to Chapter 21;597
48.1;BACKGROUND;597
48.2;PREVENTION AND TREATMENT OF COMPLICATIONS;598
48.3;SUMMARY;601
48.4;APPENDIX: RESOURCES WITH ADDITIONAL INFORMATION ABOUT VASCULAR ACCESS DEVICES;603
48.5;REFERENCES;604
49;Osseointegrated Dental Implants;606
49.1;INTRODUCTION;606
49.2;IMPLANT-SUPPORTED PROSTHESES;610
49.3;TYPICAL CLINICAL RETURN VISIT;614
49.4;APPENDIX: PARTIAL LIST OF IMPLANT MANUFACTURERS AND SUPPORT GROUPSa;616
49.5;REFERENCES;617
50;US Counterpoint to Chapter 22;622
50.1;APPENDIX:SOURCES OF FURTHER INFORMATION ON OSSEOINTEGRATED DENTAL IMPLANTS;625
50.2;REFERENCES;625
51;European Counterpoint to Chapter 22;627
51.1;INTRODUCTION;627
51.2;THE PERI-IMPLANT ENVIRONMENT;628
51.3;PERI-IMPLANTITIS AND BACTERIAL PLAQUE;628
51.4;MECHANICAL COMPLICATIONS;629
51.5;IMPLANT-SUPPORTED PROSTHESES IN THE UNITED KINGDOM;629
51.6;MAINTENANCE OF DENTAL IMPLANTS;629
51.6.1;Prosthetic Factors;630
51.6.2;Soft-Tissue Factors;631
51.6.3;Bone Factors;631
51.6.4;Oral Hygiene Factors;631
51.7;SUMMARY;632
51.8;REFERENCES;632
52;Cardiac Pacemakers;635
52.1;INDICATIONS FOR PACEMAKER THERAPY AND NEED FOR FOLLOW-UP;635
52.2;THE CLINIC VISIT;638
52.3;ENVIRONMENTAL EFFECTS ON PATIENTS WITH PACEMAKERS;643
52.4;REFERENCES;645
53;US Counterpoint to Chapter 23;647
53.1;INTRODUCTION;647
53.2;REFERENCES;649
54;European Counterpoint to Chapter 23;651
54.1;FOLLOW-UP;652
54.2;MODE SELECTION AND PROGRAMMING;653
54.3;NEW DEVELOPMENTS;655
54.4;REFERENCES;655
55;Joint Prostheses and Internal Fixation Devices;657
55.1;INTRODUCTION;657
55.2;TYPES OF ORTHOPEDIC BIOMATERIALS;662
55.3;TOTAL JOINT ARTHROPLASTY;663
55.4;DETECTION OF FAILURE OF FRACTURE FIXATION DEVICES;665
55.5;DETECTION OF PROSTHETIC INFECTION;667
55.6;MANAGEMENT OF THE CONDITION FOR WHICH THE IMPLANT WAS INSERTED;669
55.7;PREVENTIVE MEASURES;671
55.8;POSTOPERATIVE FOLLOW-UP;674
55.9;WHAT HEALTH MAINTENANCE MEASURES ARE WARRANTED?;675
55.10;APPENDIX: SUPPORT GROUPS AND PATIENT INFORMATION FOR MUSCULOSKELETAL DISEASES;676
55.11;APPENDIX: SUPPORT GROUPS AND PATIENT INFORMATION FOR MUSCULOSKELETAL DISEASES ( CONTINUED);677
55.12;REFERENCES;677
56;US Counterpoint to Chapter 24;681
56.1;REFERENCES;685
57;European Counterpoint to Chapter 24;688
57.1;TOTAL JOINT ARTHROPLASTY;688
57.2;TOTAL JOINT ARTHROPLASTY FAILURE;690
57.3;IMPLANTS FOR FRACTURE FIXATION;690
57.4;THROMBOEMBOLIC PROPHYLAXIS;691
57.5;WHAT HEALTH MEASURES ARE WARRANTED? Arthritis and Total Joint Replacements;692
57.6;APPENDIX: SOURCES OF ADDITIONAL INFORMATION;692
57.7;APPENDIX: SOURCES OF ADDITIONAL INFORMATION (CONTINUED);693
57.8;REFERENCES;693
58;Index;695