The document discusses quality control techniques used to reduce vascular complications after coronary angiography and interventions. Over three periods, techniques were evaluated and modified. The use of radial approach increased from 54% to 92% while femoral decreased from 45% to 6.8%, reducing early complications from 1.7% to 0.7%. Training nursing staff improved adherence to recommendations from 70% to over 90%, ensuring continuity of care between departments. The strategies effectively reduced complications, with radial access being the most impactful factor and training improving interprofessional communication and patient care.
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Reducing Vascular Complications After Coronary Procedures
1. USEFULNESS OF QUALITY CONTROL
TECHNIQUES TO REDUCE
VASCULAR COMPLICATIONS AFTER
CORONARY ANGIOGRAPHY AND
INTERVENTIONS
Garcimartín P,
González P, Maull E,
Encinas S, Pueyo MJ,
Sánchez D, Simó M,
Bartolomé Y
Cardiac Catheterization Unit. Hospital del Mar, Barcelona, Spain.
3. Introduction
• Getting the highest level of quality is one of the most
important objectives of the healthcare activity .
• Design tools to evaluate and diagnose problems
• Year 2006: the CathLab nurses started to visit the
patients in the 24 hours after the procedure and
registered:
– The incidence of peripheral vascular complications
(vascular approach, type of intervention, haemostasis
method)
– Fullfiment of the Cath Lab nurses recomendations
4. Aim
1. Evaluate the efficacy of different procedures in
order to reduce the incidence of vascular
complications in patients undergoing coronary
angiography and angioplasty.
2. Evaluate the effectiveness of training sessions
given to hospitalization unit nurses to fulfill the
recommendations (haemostasis device retrieval
and first mobilization after procedure).
5. Methods
• Design : Observational and prospective study
• Final sample : 3250 patients
• First period: March 2006 to January 2008: 1070 patients
• Second period: February 2008 to December 2010: 967 patients
• Third period: January 2011 to June 2013: 1213 patients
– Exclusion criteria : patients transferred to another hospital
• Data obtained:
– gender, hospitalization unit
– type of procedure : coronary angiography, angioplasty
– vascular approach : radial, femoral, braquial, ulnar
– haemostasis methods : compressive radial bandage, TR Band®,
compressive femoral bandage, arterial closure device (ACD) :
Angioseal®, StarClose®.
6. Methods
• Data :
– Complications
• According to the presentation time :
– Early complications : <3h after procedure
– Late complications : >3h after procedure
• According to the importance of the event1,2 :
– Major complications: hematoma >10cm, bleeding with blood
transfusion requirement and pseudoaneurysm requiring
surgery
– Minor complications: hematoma <10cm, bleeding without
need for transfusion, pseudoaneurysm not requiring surgery
– Fulfillment of indications :
• Retrieval of the bandage
• Mobilization after the procedure
1.
2.
Dumont CJ et al. DCCN 2006;25(3):137-142.
Sedlacek MA et al. DCCN 2010;29(3):145-152.
7. Methods
• Statistical analysis :
– Qualitative variables: counts and percentages,
– Contrast between groups : Chi square test
– Concordance between recommended times and
real times : Kappa index.
– Significance level p ≤ 0.05.
• Data was analyzed with SPSS software version
21.0.
8. Results
1st period
3rd period
(n=1070)
Gender
2nd period
(n=967)
(n=1214)
Men 748 (69.9%)
Men 675 (69.7%)
Men 852 (70.2%)
Women 322 (30.1%)
Women 292 (30.2%)
Women 362 (29.8%)
Type of
Angiography 583
Angiography 536
Angiography 607
procedure
(54.5%)
(55.4%)
(50%)
Angioplasty 487
Angioplasty 431
Angioplasty 607
(45.5%)
(44.6%)
(50%)
Vascular
Radial 580 (54.2%)
Radial 677 (70%)
Radial 1117 (92%)
approach
Femoral 488 (45.6%) Femoral 281 (29.1%)
Femoral 82 (6.8)
Brachial 2 (0.2%)
Brachial 7 (0.7%)
Brachial 5 (0.4%)
Ulnar 2 (0.2%)
Ulnar 10 (0.8%)
10. Results : early vascular complications
1st Period
1.7%
3%
2nd Period 2.8%
p ns
95.3%
No
Bleeding
2.9%
94.3%
Hematoma
NO
3rd Period 0.7%
Bleeding
Hematoma
1.6%
p<0.05
97.7%
No
Bleeding
Hematoma
11. Results : early bleeding
25%
22.7%
20%
p<0,05
15%
11.8%
11.3%
10.7%
10%
10.8%
p<0,05
5%
3.4%
0-8%
0%
0%
0-4%
Rad_bandag
0.5%
0%
0%
TR-Band®
1st period
0% 0%
Fem_bandag
2nd period
0%
Angioseal®
3rd period
Starclose®
12. Results : early hematoma
14%
12.1%
12%
p ns
p<0,05
10%
10%
8.8%
8%
6%
4.9%
4.5%
3.8%
4%
2.7%
2.2%
2%
2.2%
1.6%
2%
1.4%
1%
0%
2.7%
0%
Rad_bandag
TR-Band®
1st period
Fem_bandag
2nd period
Angioseal®
3rd period
Starclose®
13. Results : late vascular complications
1st Period
2nd Period
4%
p<0.05
0.2%
2.9%
11.3%
0.2%
2.4%
84.5%
94.2%
NO
Bleeding
Hematoma
Pseudoaneurysm
NO
Bleeding
Hematoma
Pseudoaneurysm
3rd Period
1.6% 1.3% 0.6%
p<0.05
96.5%
NO
Bleeding
Hematoma
Pseudoaneurysm
15. Results : late hematoma
12%
p<0,05
9.8%
10%
8.1%
p ns
8%
7.2%
6.3%
6%
4.7%
4.5%
3.6%
4%
3%
2.2%
2.2%
2%
1.2%
2.4%
1.6%
1%
0%
0%
Rad_bandag
TR-Band®
1st period
Fem_bandag
2nd period
Angioseal®
3rd period
Starclose®
16. Recommendation vs. practice
in compressive bandages
99.6%
100%
100%
92.2%
96.1%
90%
80%
88.6%
70%
74.2%
83%
95.6%
76.3%
60%
50%
40%
30%
> 12h
20%
10%
0%
6h
IK = 0,799
1st period
IK = 0,826
2nd period
IK = 0,922
3rd period
4h
6h
> 12h
4h
17. Recommendation vs. practice
in mobilization
99.3%
99.5%
100%
97.6%
90%
80%
96.2%
70%
60%
87.6%
71.3%
73.3%
98.3%
50%
50%
40%
30%
> 12h
20%
10%
0%
4-12h
IK= 0,583
1st period
IK= 0,782
2nd period
IK= 0,953
3rd period
0-4h
4-12h
> 12h
0-4h
18. Initial situation
1.- To modify protocol TR Band
1.- ↓ bleeding from TR Band®
2.- Training in ACD
2.- ↓ complications using ACD
3.- Training sessions for ward
nurses
3.- ↑ fulfillment of
recommendations (to 80%)
1.- Lower incidence of early
bleeding in TR Band but
worsened in later bleeding
1.- Use of TR Band only after
angioplasty
1.- ↓ complications incidence in
TR Band
2.- Decrease of
complications ACD
2- We didn’t do a specific
intervention
2- Maintain the decrease.
3.- Fulfillment of
recommendations 80%
3rd period
(2011-13)
1.- Bleeding from TR
Band®
3.- Fulfillment of
recommendations 70%
2nd period
(2008-10)
Expected results
2.- Complications with ACD
1st period
(2006-08)
Intervention
3.- Training sessions for ward
nurses
3.- Fulfillment of
recommendations >80%
1.- Same incidence of
complications with TR Band
as in the 2nd period.
1.- TR Band no longer used
Keep down complications < 4%
2.- Same incidence of
complications with ACD
as in the 1st and 2nd period
2.- Continued training of
medical staff
3.- Fulfillment of
recommendations > 90%
3.- Perform training sessions
every 6 months
Keep up fulfillment
recommendations > 90%
19. Discussion
1. Femoral haemostasis
– Less complication rate with compressive bandages than ACD
– Use of ACD: early ambulation, shorter hospital stay
2. Femoral complications rate
– It varies widely in the literature published
– Existence of various definitions for Major complications
3. Radial haemostasis
– Less complication rates with radial bandages than TR Band
– No standard protocol of use of TR Band
4. Radial approach complication rate
– It varies widely in the literature reviewed
– Existence of various definitions for Major complications
– Is significantly lower than femoral
20. Conclusions
• Most of the strategies planned to reduce complications
have been effective.
• Radial approach is the most important factor in reducing
complications
• The training sessions to nursing staff :
– Improve the fulfillment of the recommendations
regarding the removal of compression bandage and
mobilization of patients
– Ensure continuity of care
– Improve communication between professionals
Good morning
Thank you chairman, organization and the scientific committee for accepting our communication.
This study was done at the Hospital del Mar, it is an university hospital situated in Barcelona city and it has 450 beds.
The cath lab was opened in 2003, has a caseload of about 1200 patients every year, and a team of 3 interventional cardiologists and 6 nurses.
I’ve nothing to disclouse
Getting the highest level of quality is one of the most important objectives for the quality of care.
For this purpose it is necessary to design tools that allow us to evaluate and diagnose problems
In 2006 the cath lab nurses start to visit the patients in the 24 hours after procedure and registered :
the incidence of peripheral vascular complications
The fulfillment of the cath lab nurses recommendations
We had two objectives for this study :
First : Evaluate the efficacy of different procedures in order to reduce the incidence of vascular complications in patients undergoing coronary angiography and angioplasty.
And second : Evaluate the effectiveness of training sessions given to hospitalization unit nurses to fulfill the recommendations
This is an observational, prospective study
Our sample is 3250 patients and we have included all patients who have coronary angiography and Angioplasty and that could have the second visit performed. We have divided into three periods to compare the effectiveness of interventions designed
Other variables that has been collected are : Gender, hospital unit, type of procedure, vascular approach, and haemostasis methods.
In our cath lab the haemostasis methods for radial approach used are: compressive radial bandage and TR Band®
And the haemostasis methods for femoral are : compressive femoral bandage and 2 arterial closure devices : Angioseal® and StarClose®.
We have classified the complications according to the presentation time and the important to even
We have classified early complications which appear up to 3 hours after procedure, and later which appear after that time until the second evaluation.
We have classified major complications as previously describes when appear hematoma more than ten centimeters, bleeding with blood transfusion requirement and pseudoaneurysm requiring surgery
And minor : hematoma more than10cm, bleeding without need for transfusion, pseudoaneurysm not requiring surgery
We also write down the fulfillment of cath lab nurses indications about retrieval of the bandages and start the mobilization, and the time that these indications are realized
The qualitative variables are expressed in counts and percentages
The contrast between groups has been done with chi square
For concordance between recommended times and real times we have used the Kappa index.
The statistical significance level is set and zero point zero five
The statistical analysis was perform with SPSS 21
In this slide, you can see the results regarding gender, type of procedure and vascular approach in the three period.
During these periods there have been more cardiac catheterizations for men than women.
There has been a gradual increase in the number of angioplasties on the coronary angiography
Also, there has been increased use of the radial approach.
At present it is the main election approach in 92 % of the cases
This slide describes the haemostasis methods in each period
In the 1st period we used mechanical devices more than bandages.
In the 2nd and the third periods we used radial bandages more than the TR band, while for the femoral approach we used both, the bandages and vascular closures.
In this slide, you can observe the rate of early complications in the three periods, If you look at the total numbers:
4.7%
5.7%
2.3%
All of these were minor complications
The low incidence of complications is significant in each period.
We also found significant differences when comparing the 2 nd period with the 3rd but not between the 1 St and the 2 nd
In this graph we compare the early bleeding in in each of the haemostasia devices
We have found significant differences because :
There are less bleeding in radial bandage than in in TR Bands, and less bleeding in femoral bandage than in arterial closure devices
In this graph we compare the early hematoma in in each of the haemostasia devices
We have found significant differences because : There are less bleeding in radial bandage than in in TR Bands, but we haven’t found differences in femoral approach because is the same hematoma in bandage as in the arterial closure devices
In this slide, you can observe the rate of late complications in the three periods, If you look at the total numbers:
15,5%
5,5%
3,5%
All bleeding and pseudoaneurysm were minor complications, but we had 4 major hematomas (3.8%)
The low incidence of complications is significant in each period and also when compare the three period.
In this graph we compare the late bleeding in in each of the haemostasia devices
We have found significant differences because :
There are less bleeding in radial bandage than in in TR Bands, and less bleeding in femoral bandage than in arterial closure devices
In this graph we compare the late hematoma in in each of the haemostasia devices
We have found significant differences because there are less hematoma in femoral bandage than in arterial closure devices, but there are the same hematoma in radial bandage as in TR Bands.
In this slide, we compared the time that we recommended the retrieval of the compressive bandage and the real time of retrieval.
The results shows the concordance of time in percentages and, under the column, the index kappa
If you look the blue columns, when we recommended the retrieval of the bandage 4 hours after procedure, in the first period it was fulfilled in 76% of cases, 88,6% in the second period and 95,6% in the third period.
You can see how the concordance rate has improved in each of the periods, and we have now obtained results of excellence : 0,922
In this slide, we compared the time that we recommended the mobilization of the patients with the real time mobilization.
If you look the blue columns, when we recommended mobilization within 4 hours after procedure, in the first period it was fulfilled in 71% of cases, 87,6% in the second period and 98,3% in the third period.
You can see how the concordance rate has improved in each of the periods, and we have now obtained results of excellence : 0,953
In this slide I will explain the interventions that were done in each period to improve our results.
If look at the rows :
1st period
Was more bleeding in TR Band, we modified the protocol of the TR band
more complications with mechanical devices and we had training in vascular closure devices
and 70% fulfillment of recommendations and we had training sessions for ward nurses
With these interventions, we expected : to reduce the incidence of complications in TR Band and vascular closure devices, and increase fulfillment of recommendations to 80%.
2nd period
improved the incidence of immediate complications in the TR band but worsened in later complications and decided use of TR Band only after angioplasty
decrease of complications with vascular closure devices
achieved 80% of fulfillment of recommendations continued with the nurses training sessions.
With these interventions, we expected : to reduce the incidence of complications in TR Band and increase fulfillment of recommendations above 80%,
3rd period
the same incidence of complications with TR Band as in the 2nd period, we decided stop using TrBand,
the same incidence of complications with mechanical devices as in the 1st and 2nd period, we have training sessions for new medical staff on vascular closure devices
fulfillment of recommendations above 90%, we continue with the nurses sessions
With these interventions, we expect : to maintain complications below 4% and Keep up fulfillment recommendations more than 90%
We had less complications in the compressive bandages than the arterial closures devices. The literature provides similar results. Use of the ACD is that they allow early ambulation and a shorter hospital stay
The complication rates in the femoral approach in the literature range from 3.5% to 35%, but not always specific if are major or minor complication.
In our study it was more effective to use bandages than TRBands, but may be due to the protocol that we used
The vascular complications in the radial vary widely in the literature reviewed, but not always specific if complications are major or minor. In all papers reviewed that compared the incidence of complications in both approaches, they are significantly lower in radial.
To conclude:
Most of the strategies planned to reduce complications have been effective.
The most important factor in reducing complications is using Radial approach
With nurses training sessions we managed to improve fulfillment recommendations , ensure continuity of care and improve interprofessional communication