Percutaneous cardiovascular intervention procedures (e.g. coronary angioplasty, peripheral artery angioplasty) must be performed in person, requiring the physical presence of one or more medical, nursing and technical professionals. The control of catheters and interventional materials is performed manually, with the operator positioned next to the patient. This context results in potential for reciprocal exposure to exhaled air, both for the professionals involved and for the patient, with an inherent risk of aerial contamination. It is important to note that interventional procedures are often performed on an urgent or emergency basis (e.g. myocardial infarction), without the possibility of postponement or postponement. The recent robot-assisted cardiovascular intervention makes it possible to modify this scenario by allowing the procedure to be performed effectively and safely in a position far from the patient. In an environment with high potential for contamination, mainly related to the current pandemic caused by the COVID-19 virus, may prove to be a tactic to expand hospital security. It is in this sense that the present pilot proposal is inserted, which, ultimately, aims to evaluate the potential of robotic intervention as a strategy to reduce exposure to exhaled air of patients and professionals during the intervention procedure.
Percutaneous cardiovascular intervention procedures (e.g. coronary angioplasty, peripheral
artery angioplasty) must be performed in person, requiring the physical presence of one or
more medical, nursing and technical professionals. The control of catheters and
interventional materials is performed manually, with the operator positioned next to the
patient. This context results in potential for reciprocal exposure to exhaled air, both for
the professionals involved and for the patient, with an inherent risk of aerial
contamination. It is important to note that interventional procedures are often performed on
an urgent or emergency basis (e.g. myocardial infarction), without the possibility of
postponement or postponement.
The recent robot-assisted cardiovascular intervention makes it possible to modify this
scenario by allowing the procedure to be performed effectively and safely in a position far
from the patient. In an environment with high potential for contamination, mainly related to
the current pandemic caused by the COVID-19 virus, may prove to be a tactic to expand
hospital security.
It is in this sense that the present pilot proposal is inserted, which, ultimately, aims to
evaluate the potential of robotic intervention as a strategy to reduce exposure to exhaled
air of patients and professionals during the intervention procedure.
Procedure: Robot Assisted Percutaneous Cardiovascular Intervention
Robot Assisted Percutaneous Cardiovascular Intervention
Inclusion Criteria:
- Age> = 18 years;
- Cardiovascular disease characterized by:
- Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia
with one or more target lesions OR
- Symptomatic peripheral arterial disease and / or with objective evidence of the need
for percutaneous intervention of one or more target lesions;
- The target lesion (s) must be obstructive and / or aneurysmatic (visual analysis);
- Interventionist planning for all target lesions should include robotic manipulation in
at least one treatment period, according to the operator's judgment;
- The patient will be informed about the nature of the study, agree with its rules and
will provide written informed consent, approved by the local Ethics Committee.
Exclusion Criteria:
- Platelet count <50,000 cells / mm3 or> 700,000 cells / mm3;
- Total leukometry <3,000 cells / mm3;
- Suspected or documented active liver disease, with blood dyscrasia with INR <1.5;
- Heart transplant recipient;
- Allergies known to aspirin, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin,
antiproliferative agents of the limus family, or stainless steel;
- Patient with a life expectancy of less than 1 month;
- Any significant medical condition that in the investigator's opinion may interfere
with the patient's ideal participation in this study;
- Participation in another research in the last 12 months, unless there can be direct
benefit to the research subject;
- Any invasive cardiac or non-cardiac treatment scheduled in the first month after the
index procedure.
Hospital Israelita Albert Einstein
São Paulo, Brazil
Investigator: Pedro A Lemos, MD
Contact: +55 (11) 2151-0449
pedro.lemos@einstein.br
Investigator: Marcelo Franken, MD
Pedro Lemos, MD
+55 (11)98317-5000
pedro.lemos@einstein.br
Pedro Lemos, MD, Principal Investigator
Hospital Israelita Albert Einstein