Vascular complications in patients who underwent endovascular cardiac procedures: multicenter cohort study*

ABSTRACT Objective: to analyze vascular complications among patients who underwent endovascular cardiac procedures in the hemodynamic laboratories of three referral centers. Method: a multicenter cohort study was conducted in three referral facilities. The sample was composed of 2,696 adult patients who had undergone elective or urgent percutaneous cardiac procedures. The outcomes were vascular complications, such as: hematoma at the site of the arterial puncture; major or minor bleeding; surgical correction for retroperitoneal hemorrhage; pseudoaneurysm; and arteriovenous fistula. Results: 237 (8.8%) of the 2,696 patients presented a vascular complication at the site of the arterial puncture. The total number of vascular complications was 264: minor hematoma<10cm (n=135); stable bleeding (n=86); major hematoma ≥10cm (n=32); and unstable bleeding (n=11). There were no retroperitoneal hematoma events, pseudoaneurysm or arterial venous fistula. Most of the major and minor complications occurred in the first six hours after the procedure. Conclusion: the results concerning the current context of interventional cardiology indicate that the complications predominantly occur in the first six hours after the procedure, considering a 48-hour follow-up. The staff should plan and implement preventive measures immediately after the procedures.


Introduction
The implementation of more complex procedures and aggressive anticoagulation regimes has affected the incidence of complications among patients undergoing endovascular procedures in Hemodynamic Laboratories (1)(2)(3) . Vascular events stand out among the most frequent complications, such as bleeding at the insertion site, hematoma, pseudoaneurysm, arterial thrombosis, and distal embolization (4)(5)(6)(7) .
One study addressed 11,119 patients who had undergone percutaneous coronary intervention (PCI) and 189 (1.7%) of them presented vascular complications.
Nevertheless, the rapid development of knowledge and wide availability of a technological arsenal in leadingedge hemodynamics laboratories, combined with the use of more powerful anticoagulation regimens, have impacted the occurrence of vascular complications in patients undergoing invasive cardiac procedures (2,10) .
From this perspective, this multicenter study takes into account this new context in which it is important to update knowledge concerning the incidence of vascular complications, in three referral facilities. This study's objective is to analyze vascular complications among patients undergoing endovascular cardiac procedures in the hemodynamics laboratories of the three referral centers.

Methods
This multicenter, prospective cohort study was Patients of both sexes aged ≥18 years old who underwent elective or urgent endovascular procedures (cardiac catheter or PCI) through puncture of the femoral or radial artery were included. Patients lacking the clinical or mental conditions to sign free and informed consent forms or without the presence of a family companion were excluded.

Results
Out of a total of 2,718 potentially eligible patients,  Table 1.
A total of 237, out of 2,696 patients, presented some type of vascular complication (8.8%). The following results refer to vascular complications analyzed according to event, considering that patients may have experienced more than one complication. The total number of complications was 264 (9.8%), distributed as follows: minor hematoma <10cm (n=135), followed by stable bleeding (n=86), major hematoma ≥10cm (n=32), and unstable bleeding (n=11). No retroperitoneal hematoma, pseudoaneurysm, or arteriovenous fistula occurred. Data presented in Figure 1.   "Other complications" were also investigated (vasovagal reaction, allergy, pyrogenic, arrhythmia, ischemia, embolism, and congestive and neurological complications) and 132 (4.9%) complications were found. Table 3 presents the occurrence of "other complications" stratified by subtype.
A greater incidence of these complications was also observed in the first six hours after the procedure. There is also a difference in the number of patients according to type of complication due to missing data.   p <0.001). Complications and clinical outcomes also remained constant, with a downward tendency (18) . The study addressed patients whose procedures included arterial femoral and transradial access. Attention, however, should be paid to complications, regardless of the type of access chosen, because even though transradial access has been increasingly used, many procedures are still performed using the femoral route.
Thus, patients need to be continuously assessed by the nursing staff to rapidly identify events.
Another study intending to decrease the rate of vascular complications after procedures performed in the femoral artery reports that the use of fluoroscopic demarcation of the femoral head before access, smallsized introducers, and implementing the procedure in a referral center, contribute to decreasing the incidence of vascular complications (19) . The variables identified as protective factors for the non-occurrence of vascular complications are relevant, as the staff can opt to use small caliber introducers, which in fact decreases vascular complications (20) .

Vascular complications most frequently took place
in the first six hours after the invasive procedure, showing that the nursing staff has the opportunity to take action in order to prevent and decrease the frequency of major complications. Patients in recovery require special attention, that is, individual and integral care (21)(22)(23) .

Discussion
Nursing prescriptions in the postoperative period should include the duration of rest, verification of pulse, site of puncture, vital signs, and emphasize care concerning bleeding and hematoma. The nursing staff should be qualified to safely implement care.
When the incidence of other complications is analyzed, vasovagal reaction appears as the most frequent complication, at 2.6%, a finding that is also reported by other studies (9) . A study recently conducted to predict the risk of vasovagal reaction among patients who underwent PCI, reports an incidence of 4.5%, the independent factors included being a woman, primary coronary angioplasty, SBP, more than two stents implanted in the anterior descending artery, and puncture at the femoral site (24) . When patients who underwent cerebral angiography exclusively using the femoral access are included, indexes vary little (4.09%) (25)  Similar to previous studies, allergy was not a very frequent event (9,(26)(27) . Hypersensitive responses should be taken into account when choosing the contrast media for procedures. A double-blind randomized study assessed the nonionic contrast, iso-osmolar, and lowosmolarity ionic contrast and verified that hypersensitive responses (2.5% vs. 0.7%) were statistically less frequent (p=0.007) in the group using the nonionic and isoosmolar contrast media (28) . Due to the use of increasingly modern contrast media with low osmolarity, allergic responses are increasingly rare, so that patient safety has advanced in this aspect.

Conclusion
The results show that the general incidence of (major and minor) vascular complications in the first 48 hours in three referral centers in the south of Brazil is lower than that reported in many international referral centers. There was no occurrence of pseudoaneurysm, retroperitoneal hematoma, or arteriovenous fistula in this study. In regard to other complications, those with the highest incidence were vasovagal reactions and allergic responses.
The incidence of these complications predominantly This study's findings contribute to knowledge concerning complications that patients undergoing endovascular cardiac procedures may experience, which can support the planning of care provided before and after procedures.