Tabla 1. Characteristics of the population (N = 2055 patients)..

Tabla 2. Clinical signs that triggered the procedure (N = 2055 patients).

Tabla 3. Procedures performed (N= 2055 patients).

Tabla 4. Vascular access (N = 2055).

Tabla 5. Complications per type of procedure (N =2529).

Tabla 6. Overall complications (N = 2529)..

Tabla 7. Analysis of dead patients

Tabla 8. Access-related complications.

INTRODUCTION

Over the past few decades, interventional cardiology has experienced an exponential growth from performing simple diagnostic studies1 to more complex therapeutic procedures like transcatheter aortic valve implantations or percutaneous coronary interventions to treat chronic total coronary occlusions.2-4 In Argentina this growth has been confirmed, annually, in the voluntary registry of general procedures performed in Argentina as reported by the Argentine College of Interventional Cardiology (CACI) that has been collecting data since 2007.5

Although refinement in the materials used, the increased number of procedures performed, and the experienced gained by operators themselves has had a positive impact on the rate of complications, the approach of the most difficult cases associated with more powerful antiplatelet and anticoagulant therapies has impacted the occurrence of such complications negatively.6,7

The objective of this study is to analyze the complications of patients treated with diagnostic and therapeutic procedures in the cath lab of a high complexity health center.

MATERIALS AND METHODS

This registry was started back in 2019 at the cath lab of Hospital El Cruce - Dr. Néstor Carlos Kirchner SAMIC (HEC), Buenos Aires, Argentina. Data mining took place from August 2019 through October 2021.

An app was built for smartphones with AppSheets (a tool built by Google) that provides a platform to develop applications for smartphones. The data entered in the app were sent to a confidential database.

All the patients admitted to the center to undergo a diagnostic and/or therapeutic procedure on an elective or emergency basis were prospective and consecutively included. The registry was completed 24 hours after finishing the procedure in patients admitted to the HEC and when they were discharged from this center (both in ambulatory patients and in those coming from other centers who were sent back to their centers of origin once the procedure was completed).

Cardiovascular risk factors were also included like arterial hypertension, smoking, dyslipidemia, and diabetes. The past medical history studied included previous acute myocardial infarction (AMI), previous percutaneous coronary intervention (PCI), previous myocardial revascularization surgery, and chronic kidney disease. The clinical signs that triggered the procedure were included within the following categories depending on which was considered the most appropriate one: non-ST-segment elevation acute coronary syndrome (NSEACS) or ST-segment elevation acute coronary syndrome (SEACS), the patient’s hemodynamic status based on the Killip-Kimball (KK) classification, discard chronic coronary artery disease (CAD), postinfarction angina (PIA), post-AMI stratification/evolving AMI, coronary artery disease, sudden death/ventricular arrhythmia, dilated cardiomyopathy (DCM), valvular heart diseases, peripheral vascular disease, heart transplant follow-up, other conditions.

For better analysis, the procedures available at the cath lab to treat all vascular territories were categorized into diagnostic and therapeutic. In relation to other procedural technical aspects, the access route was registered as well (radial, humeral, femoral, and venous accesses), as well as the French size used. The complications included in the analysis were categorized into minor (arrhythmias, hypersensitivity, heart failure [HF], other), and major complications (bleeding, vascular complications, stroke, and death). Hemorrhages were assessed according to the criteria established by the Bleeding Academic Research Consortium (BARC),8 and those ≥ 2 were registered. The vascular complications included were pseudoaneurysm, arteriovenous fistula (AVF), perforations, emboli/thromboses, dissections, radial artery occlusions, acute stent thromboses,19 and perioperative Q-wave/enzymatic infarction.

Statistical analysis

Categorical variables were expressed as absolute values, percentages, and associations. The quantitative ones as mean and standard deviations with their maximum, minimum, and ranges, when appropriate. The statistical comparison among the different qualitative variables was conducted using the chi-square test with or without Yates Correction. In all the analyses, P values < .05 were considered statistically significant.

RESULTS

A total of 2055 patients were included in the analysis. The demographic characteristics, prevalence of cardiovascular risk factors, and the patients’ past medical history are shown on Table 1. A total of 77.46% (n = 1592) of the patients were men with a mean age of 54.9 ± 10.45 years (range, 15-89). Table 2 shows the clinical signs that triggered the procedure, among others, coronary artery disease was the most common clinical sign in 56.91% of the cases (STEACS, NSTEACS, chronic CAD, post-AMI stratification, and PIA). Among the patients with STEACS, (n = 231), (n=231), KK-A was the most prevalent classification in 64.93% while 9.95% of the patients were categorized as KK-D.

A total of 2529 procedures were performed: 1820 diagnostic procedures (71.96%), and 709 therapeutic ones (28.04%). Table 3 shows the data associated with such procedures. Right radial access and 6-Fr introducer sheaths were the most widely used of all (table 4). A total of 45.54% (n = 936) of the patients recovered at the hemodynamics and interventional cardiology unit, 34.84% (n = 716) were admitted to the HEC, and 19.62% (n = 403) were sent back to their referring hospitals once the procedure was completed. During the follow-up of 2055 patients, a total of 89 complications in 83 patients (4.03%) were reported. Among these complications, the most common ones were vascular complications (n = 35) followed by death (n = 22), and bleeding (n = 13) (Tables 6 and 7). Acute stent thrombosis and pseudoaneurysm/AVF were the most common complications reported within the group with vascular complications. A total of 7 of these access site-related vascular complications required an active approach (whether surgical or endovascular) for their resolution while 16 were treated conservatively.

In the 2529 procedures performed, diagnostic procedures were associated with a rate of complications of 0.98% (18/1820). A total of 7 minor (2 arrhythmias, 3 patients with hypersensitivity, 2 HFs), and 11 major complications (4 vascular complications, 4 hemorrhages, 3 deaths, and 0 strokes) were described. The rate of complications associated with therapeutic procedures was 10.01% (71/709). A total of 12 minor (6 arrhythmias, 1 hypersensitivity, 3 HFs, and 2 other complications), and 59 major complications (31 vascular complications, 9 hemorrhages, 19 deaths, and 0 strokes) were described. Among the 22 patients who died, 14 developed STEACS (3, 2, and 9 patients were categorized as KK-A, KK-B, and KK-D, respectively). A total of 3 patients developed NSTEACS, 1 chronic CAD, and 2 developed acute aortic syndrome. A total of 2 patients died in the context of hypovolemic shock due to digestive bleeding refractory to treatment. Complications associated with other therapeutic procedures are shown on Table 5.

Mortality rates were 0.73% (1/136), 1.12% (2/178), and 6.06% (14/231) for scheduled PCI, PCI to treat NSTEACS, and PCI to treat STEACS, respectively. Out of all PCIs performed, in 76.15% (415/545) the radial access was the route of choice followed by the femoral access [23.48% (128/545) of the cases]. Humeral access (0.36%) was used in 2 patients only.

A comparative analysis of the complications described between radial arterial access (RAA) and femoral arterial access (FAA) was conducted (table 8). After excluding patients with venous accesses and different arterial accesses, no significant differences were ever reported in the appearance of vascular complications (P = .19), arrhythmias (P = .32), hypersensitivity (P = .34) or bleeding (P = .051) in association with the arterial access used. The overall mortality rate, however, was significantly higher in those cases treated via femoral access (P = .0001). All critical patients were treated via femoral access, which is why a deviation from the population analyzed should be taken into consideration when analyzing these last results. The highest mortality rate associated with the FAA group could be associated with more baseline morbidities in the patients of the group taking into consideration that 63.63% (n = 14) of all deaths reported occurred in patients with STEACS and 9 out of these 14 patients fell within KK-D.

DISCUSSION

These are the early results on 2055 patients from the R-HEC, a prospective, longitudinal registry whose primary endpoint was to know current data on the complications occurred through time at the Interventional Cardiology Unit of Hospital de Alta Complejidad El Cruce – Dr. Néstor Carlos Kirchner SAMIC, Buenos Aires, Argentina.

Considering all the complications studied, the total percentage was 4.03%. The scarcity of data regarding the overall complications associated with interventional procedures (the registries available mostly evaluate complications associated with a specific procedure)6,9,10 complicates the possibility of drawing a comparative analysis with data obtained from this registry.

Vascular complications were the most common of all (1.38% of the total). Such rate turned out to be relatively lower compared to results previously published with rates close to 3% that only considered major vascular complications.6,11 Waldo et al. published a study that included 194 476 cardiac catheterizations and 85 024 PCIs performed in the United States. They confirmed that patients treated with these procedures were progressively older and had more comorbidities. Both the complications and the clinical outcomes remained constant with rates of major and minor complications < 1% during the study period regarding diagnostic and therapeutic procedures.12 Since, in this registry, operators reported on the rates of complications voluntarily, these could be under-reported. In Brazil, in a multicenter registry of 2696 patients, the rate of vascular complications was 8.8%17 (without ever reporting on complications such as AVFs, pseudoaneurysms or retroperitoneal hematomas).

Out of the 13 hemorrhages reported, only 3 (3.37%) were major bleedings according to the BARC. There were 2 BARC type 2B bleedings, 1 in a right cardiac catheterization and the other associated with 1 transcatheter aortic valve replacement procedure, and 1 BARC type IIIC bleeding associated with STEACS. The BARC classification was validated in 12 459 patients treated with PCI from the ISAR trial.13 Bleeding events (according to the BARC classification) occurred in 1233 patients (9.9%). BARC type > 2 bleedings occurred in 679 patients (5.4%). The ARGEN-IAM-ST registry (Study on ST-segment elevation acute myocardial infarction) conducted in Argentina on 1142 patients reported a rate of 3.23% with only 3 patients showing major bleeding. 14

Regarding complications associated with 2 different access routes, a higher mortality rate was found in FAA compared to RAA (2.47% vs 0.42%; P = .0001). However, no statistically significant differences were found in the rate of bleeding between the FAA compared to the RAA, which means that the borderline P value obtained should be interpreted with caution since it could change with a larger number of individuals included (0.92% vs 0.28%; P = .0512). We should mention that all critical patients were approached via femoral access, which is why any deviations from the study population should be taken into consideration when analyzing these outcomes. The higher mortality rate reported in the FAA group could be associated with more baseline morbidities in the patients of the group considering that 63.63% (N = 14) of all deaths occurred in patients with STEACS and that 9 out of these 14 patients fell within KK-D. Mieres et al. published a registry that compared FAA and RAA at 30 days in patients treated with percutaneous coronary intervention. In 988 consecutive patients no significant differences were reported regarding MACCE or death + AMI + stroke between both groups. However, both mortality and cardiac death were numerically higher in the FAA compared to the RAA.18

In our registry, the overall mortality rate of STEACS was 6% (14 patients out of 231), which is somehow similar to that of the French registry FAST MI15 designed to assess the in-hospital outcomes and mid- and long-term progression being the in-hospital mortality rate associated with STEACS, 5.8%. The Argentine Registry of Coronary Angioplasty (RadAC)16 was conducted in Argentina from 2010 through 2012. It included a total of 1905 PCIs performed in 67 centers. A total of 752 of these patients showed STEACS. The in-hospital mortality rate reported by the authors for patients with STEACS was 4.6%. However, only 2.6% patients from the RadAC fell within the KK-D category compared to 10% of our registry. In the ARGEN-IAM-ST, the rate of patients who fell within the KK-D category was close of 6%. In such registry, the in-hospital mortality rate of 1142 patients from 247 different Argentine centers was 7.6%.14 Bono et al.20 recently published a registry of complications associated with STEACS in a public center from the city of Buenos Aires, Argentina. In 263 patients the overall rate of complications was 47.2% while the 48 hour-all-cause mortality rate was 7.9%. A chronological distribution analysis of the complications was conducted, and it was confirmed that 9 out of every 10 complications occurred within the first day.

STUDY LIMITATIONS

The R-HEC registry is a single-center, observational, and non-randomized clinical trial. The additional studies conducted and the treatment prior to the procedure were indicated based on the treating cardiologists. The decision on the vascular access, procedural technique used, and therapeutics depended on the heart team of the Interventional Cardiology Unit.

During all the procedures and in the postoperative of the patient, hospital ward doctors and residents participated in the healthcare process, which is why results may not be extrapolated to other units without specialist training programs.

The brief follow-up conducted at 24 hours or after hospital discharge confirmed that complications that occurred after that time were not included. There is this possibility of data loss in patients who were sent back to their centers of origin once the procedure was completed. Therefore, a mailbox was created to receive notifications on possible complications, which were the ones that were eventually registered. However, different reports show that most complications occur early as it was the case of the registry conducted by Paganin et al. that confirmed that 97% of all vascular complications occurred within the first 6 hours after the procedure17 meaning that data loss may not be significant or relevant at all.

We should mention, though, how easy it was for the investigators to fill in the forms since they could use the app of their smartphones for that purpose.

CONCLUSIONS

The rate of overall complications at the Interventional Cardiology Unit of HEC was 4% being vascular complications the most common of all. Results allow us to conclude that the overall rate of complications in a reference center in Argentina holds a favorable comparison given the scarce national data available and outcomes of other international registries. Knowing the rate of complications of patients treated with endovascular procedures allows us to plan care before and after the procedure properly. It also gives us the opportunity to give the patient proper information on the risks involved in the procedure planned.

ACKNOWLEDGEMENTS

We should mention that most of this registry was conducted during the COVID-19 pandemic. The authors wish to thank the personnel at the Interventional Cardiology Unit from Hospital El Cruce who never stopped working during that time.

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