This document evaluates the clinical efficacy and economic impact of diaphragm pacing (DP) compared to mechanical ventilation for ventilator-dependent patients from the perspective of the Brazilian Public Health System. A systematic review found low quality evidence that DP may help wean some patients from ventilation and improve quality of life. An economic analysis found that installing DP and transferring patients to home care could generate savings versus long-term intensive care. However, more data is needed on effectiveness and quality of life. Breaking the DP technology monopoly in Brazil could also potentially reduce costs.

1. v
Clinical and economic evaluation of
diaphragm pacing for ventilator-
dependent patients: a Public Health
System perspective
University of Campinas
Health Secretary of São Paulo State
Heart Institute - University of São Paulo
ADRIANA CAMARGO DE CARVALHO
VIVIAN C. ANTUNES DOS SANTOS
ERICA MIE OKUMURA
SILVIA YUKARI TOGORO
MIGUEL L. TEDDE
EVELINDA TRINDADE
ANDRÉ DEEKE SASSE

2. Brazilian Public Health System
Health: right of the population and duty of the government
SUS
Unified Health System
Universality
Integrality
Equality

3. THE PROBLEM
Higher incidence of complications
and discomfort for patients
High costs
Shortage of hospital beds
Elevate number of chronic patients in ICU only for ventilatory support

4. Surgical procedure to restoring
breathing through direct stimulation of
diaphragm
Goal: Replace, delay or reduce the
need for mechanical ventilation
Main Indications: hight cervical spinal
cord injury and other ventilatory
diseases

5. CURRENT CONTEXT
A single brand is registered by the Brazilian regulatory agency
 Commercial monopoly
 Disproportionately high costs
Elevate number of lawsuits
Costly to the public system
Few number of individuals benefited
OUR QUESTION: Is it viable to incorporate DP in the Brazillian
public health system?

6. To quantify the added benefit when DP is used compared to
the ventilator for patients with chronic respiratory failure
To evaluate the economic impact of DP use versus the use of
mechanical ventilation from the Brazilian public health
perspective
OBJECTIVES

7. SYSTEMATIC REVIEW
Clinical trials (randomized or non-randomized),
case series (prospective or retrospective),
HTA informs
Search Strategy updated up until November 2014
Two independent researchers
MEDLINE, EMBASE & Lilacs
Sensitive search strategy
Western idioms
• Population: In ventilator-dependent patients with chronic respiratory
failure...
• Intervention: ...does DP (thoracic or intradiaphragmatic)
• Comparator: ...compared to mechanical ventilation alone...
• Outcome: ... bring benefits in terms of weaning patients off of
mechanical ventilation and/or improve the quality of life?
PICO

8. Identified 72 articles using
PubMed, EMBASE and Lilacs
16 Full-text articles assessed for
elegibility
56 citations removed: did not
meet inclusion criteria
(case reports)
11 studies included in review:
• 6 retrospective estudies
• 5 prospective estudies
3 prospective non-randomized
2 prospective randomized
5 full-text articles excluded:
focus not of interest
and diverse study design
SYSTEMATIC REVIEW

9. EFFICACY CONCLUSIONS
Quality of data was low.
Risks and benefits were difficult to characterise and quantify.
Possible positive effect on weaning patients from mechanical ventilation.
Potential improvement of quality of life level.
It can be considered safe
Phrenic nerve integrity must be proven by neuromuscular tests
The most established indications are for spinal cord injury and Congenital
Central Hypoventilation

10. ECONOMIC ANALYSIS METHOD
ICU
Home Care - MV
Home Care – DP and MV
Three Different Scenarios
Design
Cost Analysis
Perspective
Brazillian Public Health System (SUS)
Cost – Data Sources
Real costs - Heart Institute - University of São Paulo (USP)
Lawsuits - Health Secretary of São Paulo State

11. Costs - MV in Intensive Care Units
263
1,913
7,820
3,150
3,020
2,576
1,095
0 1000 2000 3000 4000 5000 6000 7000 8000 9000
Hemotherapy
Honoraria
Daily Cost
Diagnostic Tests
Supplies
Drugs
Appliances and Gases
Dollars (US$)
Monthly Average Costs
Total: ~20K (US$)

12. COSTS - Diaphragm Pacing System
129,3
25
53,87
0
20
40
60
80
100
120
140
Mark IV® (Avery) NeuRx DPS System®
(Synapse Biomedical)
Atrostim PNS V2.0®
(Atrotech)
ThousandDollars(US$)
Single brand registered by the Brazilian regulatory agency
Monopolar System
Quadripolar
System

13. COSTS – Implantation of DP
318
2,530
450
328
103
0 500 1000 1500 2000 2500 3000
Multiprofessional Honoraria
Fees
Diagnostic Tests
Supplies
Drugs
Dollars (US$)
Surgery Average Costs
Total: 3,730K (US$)

14. MONTHLY HOME CARE COSTS
4,102
1,176
992
495
1,235
3,572
1,176
992
213 79
0
500
1.000
1.500
2.000
2.500
3.000
3.500
4.000
4.500
Human Resources Equipament
Leasing
Inputs Gas Therapy Services
MECHANICAL VENTILATION - Total: 8K
DIAPHRAGM PACING + MECHANICAL
VENTILATION - Total: 6K

15. 63,6
6 6 6 6 6 6
96,3
0
20
40
60
80
100
120
140
1 2 3 4 5 6 TOTAL
ThousandDollars
Months
DP – Home Care
Inicial Cost Monthly Cost Cost in 6 months
20 20 20 20 20 20
120
0
20
40
60
80
100
120
140
1 2 3 4 5 6 TOTAL
ThousandDollars
Months
MV-Intensive Care Unit
Monthly Cost Cost in 6 months
AVERAGE COSTS: Current Scenario vs DP Implantation

16. CONCLUSION – ECONOMIC ANALYSIS
The installation of the DP and the patient transfer to his residence
would generate savings of financial resources
Breaking the current monopoly and promoting market opening
would also probably reduce the costs of the technology
More appropriate economic models could be developed if there
was more and better data on efficacy/effectiveness and quality of
life

17. v
Thank you
ADRIANA CAMARGO DE CARVALHO
dricamargo@hotmail.com
ANDRÉ DEEKE SASSE
sasse@cevon.com.br