Patient Reported Outcomes and Quality of Life in Cardiovascular Interventions

Preface
Contents
1: Unveiling the Concept of Minimal Clinically Important Difference (MCID) in Cardiac Surgery
Introduction
The Purpose of Employing the MCID
Statistical and Methodological Concepts Regarding MCID
Distribution Methods
Anchor-Based Methods
Consensus (Delphi) Methods
Limitations of the MCID Methods
Potential Pitfalls to Consider When Evaluating Results Based on MCIDs
Real Life Examples of MCID Implementation in Cardiac Surgery
Conclusions
References
2: Quality of Life Following the Use of Mechanical Circulatory Support Devices
Introduction
Methods
Durable Mechanical Circulatory Support
Extracorporeal Devices
Conclusions
References
3: What Factors Predict an Improved Quality of Life Outcome Following Coronary Artery Bypass Graft Surgery? A Systematic Review
Aim
Introduction
Materials and Methods
Inclusion Criteria
Study Quality Scoring
Results
Study Design
Quality of Studies
HRQOL Tools
Outcomes
Discussion
Surgical Factors
Patient Factors
Post-surgical Complications
Patient Health Perceptions
Limitations
Conclusions
References
4: Thoracic Aortic Surgery
Introduction
Proximal Thoracic Aorta
Aortic Root Replacement/Repair
Other Proximal Aortic Operations
Type A Dissection Repair
Thoracoabdominal Aortic Aneurysm Repair
Endovascular Interventions on the Thoracic Aorta
Aortic Surgery in the Elderly
Neurological Outcomes and Cerebral Protection
Discussion
Study Limitations
Suggestions for Future Research
Conclusions
References
5: Patient Reported Outcomes and Quality of Life following Heart Transplantation
Introduction
Methods
Literature Search
Study Selection
Study Classification
Results
Comparative Studies
vs. LVADs
vs. Medical Therapy
vs. Waiting-List
Longitudinal Studies
Immediate Long-Term Follow-Up (5–10 Years Post-HTx)
Mid Long-Term Follow-Up (10–20 Years Post-HTx)
Extreme Long-Term Follow-Up (>20 years Post-HTx)
Discussion
Challenges in QOL Assessment in Transplant
Baseline QOL in Pre-transplant Patients
Physical Activity Post-transplant
Mental Well-Being Post-transplant
References
6: QOL and PROMS Following Transcatheter Aortic Valve Implantation
Introduction
Summary of Interventions (Surgical, Endovascular/Minimally Invasive) for Aortic Stenosis
Analysis of the Utility of Different QOL Tool
Methods
Discussion
TAVI Registries Reporting on QoL
TAVI vs. General Population
TAVI vs. sAVR Short and Intermediate Term Outcomes – Results from Randomised Controlled Trials (Industry Supported Studies)
Conclusions
References
7: Patient-Reported Quality of Life After Stand-Alone and Concomitant Arrhythmia Surgery: A Systematic Review and Meta-Analysis
Highlighted Conclusions
Introduction
Patients and Methods
Literature Search
PubMed
Cochrane
Study Selection and Risk of Bias
Endpoints
Statistical Analysis
Results
Study Selection
Risk of Bias
Study Population
Arrhythmia Surgery
Primary Endpoint: QOL Following Stand-Alone Arrhythmia Surgery
Primary Endpoint for Concomitant Procedures
Follow-up
Secondary Endpoint: QOL Sub-Analyses Using Other Questionnaires
Discussion
Overall Effect on QOL Following Arrhythmia Surgery for AF
Primary Endpoint: Concomitant AF Surgery and QOL
Primary Endpoint: Standalone AF Surgery and QOL
Techniques and Lesion Sets in Concomitant and Stand-Alone AF Ablation
Limitations
Conclusion
References
8: Transcatheter Mitral Valve Procedures
Introduction
MitraClip Implantation
Studies Comparing Against Conventional Surgery
Studies Comparing Against Conservative Management
Studies Considering High-Risk or Frail Patients
Miscellaneous Studies
Cardioband Implantation
Carillon Mitral Contour Device
Studies Including Other Percutaneous MV Interventions
Discussion
Study Limitations
Suggestions for Further Research
Conclusion
References
9: Percutaneous Interventions in Adult Congenital Heart Disease
Introduction
Quality of Care in Adults with Congenital Heart Disease
Why use Quality of Life Indicators in Adults with Congenital Heart Disease?
Challenges in Quality of Life Research in Adults with Congenital Heart Disease
Quality of Life Assessment Tools in ACHD
Methods
QoL Tools in ACHD Interventions: Review of Existing Literature
Results
Summary of Interventions
Percutaneous Pulmonary Valve Implantation
Percutaneous Atrial Septal Defect Closure
Patient Foramen Ovale Closure (Post-Stroke)
Discussion
QoL After Percutaneous Procedures in ACHD
The Utility of Different Quality of Life Tools in the Setting of Percutaneous Procedures in Adult Congenital Heart Disease
Comparison of PROMs with Other Established Health Outcomes
Concluding Remarks
References
10: The Impact of Valve Surgery on the Health-Related Quality of Life of Elderly Patients: Systematic Review
Introduction
Method
Data Sources and Search
Study Inclusion Criteria
Evaluation of Quality and Risk of Bias
Results
Discussion
Frailty Factor
HRQOL Outcome: PCS vs. MCS
Predictors of Quality of Life
Female Gender
Mitral Regurgitation
Coronary Artery Disease
Ejection Fraction, NYHA and LV function
Other Determinants of Quality of Life
Type of Prosthesis
Type of Surgery
Incision Factor
Limitation
Conclusion
References
11: Quality of Life After Mitral Valve and Tricuspid Valve Surgery
Quality of Life After Mitral Valve Surgery
Introduction
Methods for Assessing the Quality of Life
Negative Predictors of Quality of Life
Quality of Life in Relation to Prosthesis Type and Surgical Approach
Biological Versus Mechanical Heart Valve Replacement
Conventional Mitral Valve Intervention (Surgical Repair or Replacement) Via Median Sternotomy
Conventional Mitral Valve Interventions (Surgical Repair or Replacement) versus Minimally Invasive Approach
MitraClip Implantation
Other Percutaneous Mitral Valve Interventions
Quality of Life After Tricuspid Valve Surgery
References
12: Quality of Life and Patient Reported Outcomes in Paediatric Cardiac Surgery Patients
Introduction
Background
Patient Reported Outcomes (PROs) and Patient Reported Outcome Measures (PROMs)
Quality of Life
Parents and Caregiver Prospective
Functional Status
Symptom and Symptom Burden
Patient Experience
Health Behaviours
Tools and Measures
Summary and Conclusion
Highlighted Conclusions
Future Research
References
13: Percutaneous Coronary Intervention
Introduction
Materials and Methods
Search Strategy
Inclusion and Exclusion Criteria
Outcomes of Interest and Data Extraction
Quality Scoring
Results
Selected Studies
Study Objectives, Design and Population
Quality of Included Studies
Health-Related Quality of Life Measures Used
PCI in Stable Coronary Artery Disease
PCI in Acute Coronary Syndromes
PCI in Chronic Total Occlusions
PCI in Undifferentiated Coronary Artery Disease
Discussion
Study Limitations
Suggestions for Future Research
Conclusions
References
14: Quality of Life and Patient Reported Outcome Measures Following Carotid Artery Intervention
Introduction
Current Interventions on the Carotid Artery
Carotid Endarterectomy
Carotid Stenting
Quality of Life Instruments and Proms in Carotid Intervention
Definition of Quality of Life and Patient Reported Outcome Measures
Commonly Used Quality of Life Instruments in Carotid Intervention
Quality of Life and Patient Reported Outcomes
Quality of Life After Carotid Endarterectomy (18 Studies) [28, 31–33, 42–52, 54, 56, 57]
Quality of Life After Carotid Stenting (Seven Studies) [28, 42, 48, 50, 52, 53, 55]
Quality of Life After Endarterectomy Compared to Stenting (Five Studies) [28, 42, 48, 50, 52]
Quality of Life Compared to Reference Populations (Seven Studies) [31, 32, 45, 46, 49, 55, 56]
Cognitive Function
Utility of Quality of Life Tools
Importance of Quality of Life Assessment and PROMS
Need for Further Research
Effect of Other Outcomes on Quality of Life and Proms
Conclusion
References
15: Quality of Life and Patient Reported Outcome Measures Following Percutaneous Aortic Intervention for Aortic Aneurysms and Dissection
Introduction
Current Interventions on the Aorta
Abdominal Aorta
Abdominal Aortic Aneurysms
Thoracic Aorta
Thoracic and Thoracoabdominal Aortic Aneurysms
Type B Thoracic Aortic Dissection
Quality of Life Instruments and Proms in Aortic Intervention
Definition of Quality of Life and Patient Reported Outcome Measures
Commonly Used Quality of Life Instruments in Aortic Intervention
Quality of Life and Patient Reported Outcomes
Abdominal Aorta (29 Studies) [12, 16, 18, 25, 38, 48–68, 70–72]
Thoracic Aorta (Five Studies) [73–77]
Utility of Quality of Life Tools
Importance of Quality of Life Assessment and PROMS
Need for Further Research
Effect of Other Outcomes on Quality of Life and Proms
Conclusion
References
16: QOL and PROMS in Catheter Ablation of Cardiac Arrhythmia
Introduction
Search Strategy
Inclusion and Exclusion Criteria
Data Extraction
Quality Scoring
Results
Selected Studies and Their Objectives
Tools Used
Comparative Studies
Catheter Ablation Versus Anti-arrhythmic Drugs
Comparative Studies of Different Ablation Strategies
Between Group Comparisons
Anxiety and Depression
Exercise Performance
Healthcare Utilisation
Cryoballoon Ablation
Cavotricuspid Isthmus Ablation
Predictors of Success
Other Study Aims
Predictors of Poor Quality of Life
Limitations of the Included Studies
Critique of the Different Tools Available
Comparison to Other Outcomes
Conclusions
Appendix
Medline Search Strategy
References
17: Patient Reported Outcomes and Quality of Life following Percutaneous and Surgical Intervention for Subclavian Artery Disease
Introduction
Material and Methods
Search Strategy
Inclusion and Exclusion Criteria
Outcomes of Interest and Data Extraction
Quality Scoring
Results
Selected Studies
Studies Focusing on Percutaneous Intervention
Studies Focusing on Surgical Revascularization
Quality of Included Studies
Discussion
Conclusion
References
18: QoL and PROMS Following Percutaneous and Surgical Intervention for Renal Artery Disease
Search Strategy
Search Results
Atherosclerotic Renal Artery Stenosis: Endovascular Trials
Quality of Life Outcomes in Atherosclerotic Renal Artery Stenting
Atherosclerotic Renal Artery Stenosis: Surgical Trials
Fibromuscular Dysplasia: Endovascular
Fibromuscular Dysplasia: Surgery
Quality of Life in Fibromuscular Dysplasia
Effect of Regular Dialysis on Quality of Life
Effects of Procedural Complications on Quality of Life
Conclusion
References
19: Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions in Aortoiliac and Femoropopliteal Steno-Occlusive Arterial Disease
Introduction
Materials and Methods
Search Strategy
Inclusion and Exclusion Criteria
Study Selection and Data Extraction
Results
Study Objectives, Design and Population
Health-Related Quality of Life Outcome Measures
Studies Focused on Aortoiliac Steno-Occlusive Disease
Studies Focused on Femoropopliteal Steno-Occlusive disease
Quality of Included Studies
Timing and Completion of Follow-Up
Discussion
Appendix: Scoring Criteria to Assess Methodological Quality of Included Papers
References
20: Infrapopliteal Arteries (Classical and Percutaneous)
The Emergence and Importance of QOL and PROMS for Peripheral Artery Disease
Assessing QoL and PROMS in Peripheral Artery Disease
QoL and PROMS in Intermittent Claudication (IC)
QoL and PROMS in Chronic Limb-Threatening Ischemia (CLTI)
Limitations/Future Directions
References
21: Quality-of-Life (QOL) and Patient-Reported Outcome Measures (PROMs) Following Intervention for Chronic Venous Disease
Introduction
PROMs to Assess Chronic Venous Disease
Comparison of Surgical vs. Endovenous Interventions
High Ligation and Stripping vs. RFA
High Ligation and Stripping vs. EVLA
High Ligation and Stripping vs. Sclerotherapy
High Ligation and Stripping vs. Thermal Ablation
Comparison Between Different Endovascular Interventions
Sclerotherapy vs. EVLA
RFA vs. EVLA
RFA Plus Phlebectomies vs. EVLA Plus Phlebectomies
EVLA vs. EVLA Plus Phlebectomies
EVLA vs. EVLA Plus Sclerotherapy
EVLA vs. Thermal Ablation
Cyanoacrylate Embolization vs. RFA
Recurrence Rates Following Different Interventions
Conclusions
References
Index