International Journal of Cardiology xxx (2012) xxx–xxx

IJCA-14847; No of Pages 6

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International Journal of Cardiology

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Management and timing of access-site vascular complications occurring aftertrans-radial percutaneous coronary procedures

Francesco Burzotta ⁎, Luca Mariani, Carlo Trani, Valentina Coluccia, Marta Francesca Brancati, Italo Porto,Antonio Maria Leone, Giampaolo Niccoli, Antonella Tommasino, Giovanni Tinelli, Mario Attilio Mazzari,Rocco Mongiardo, Francesco Snider, Giovanni Schiavoni, Filippo CreaDepartment of Cardiovascular Medicine, Catholic University of the Sacred Heart, Rome, Italy

⁎ Corresponding author at: L.go Gemelli 1, 00168 Romefax: +39 06 3055535.

E-mail address: f.burzotta@rm.unicatt.it (F. Burzotta

0167-5273/$ – see front matter © 2012 Elsevier Irelanddoi:10.1016/j.ijcard.2012.05.017

Please cite this article as: Burzotta F, et al, Mtaneous coronary procedures, Int J Cardiol

a b s t r a c t

a r t i c l e i n f o

Article history:

Received 15 March 2011Received in revised form 10 February 2012Accepted 4 May 2012Available online xxxx

Keywords:Percutaneous coronary interventionsTrans-radial approachManagement of access-site vascular complications

Background: Access-site vascular complications (ASVC) in patients undergoing trans-radial coronary proce-dures are rare but may have relevant clinical consequences. Data regarding the optimal management ofradial-access-related ASVC are lacking.Methods: During a period of 6 years we prospectively collected ASVC. ASVC were defined as any complicationrequiring ultrasound examination or upper limb angiography. ASVC were categorized according to the timingof diagnosis: “very early” (in the cath lab), “early” (after cath lab discharge, but during the hospital stay) and“late” (after hospital discharge). The need of surgery (primary end-point) and the development of neurolog-ical hand deficit (secondary end-point) were assessed.Results: Fifty-seven radial-artery related ASVC were collected. ASVC diagnosis was obtained by upper limb

angiography in 25 patients (44%) and by Doppler in 32 patients (56%). Surgery was required in 6 cases(11%), the remaining patients receiving successful conservative management (which included prolongedlocal compression). Three patients (who received surgery) exhibited a mild neurological hand deficit inthe follow-up. Need for surgery differed significantly according to timing of diagnosis as it occurred in 1 of26 patients (3.8%) with “very early” diagnosis, in 1 of 21 patients (4.8%) with “early” diagnosis, and in 4 of10 patients (40%) with “late” diagnosis (p=0.026).Conclusions: ASVC are diagnosed with different timing after trans-radial procedures. Conservative manage-ment including local compression allows successful management in the majority of ASVC. Prompt recogni-tion is pivotal as late diagnosis is associated to the need for surgery.

© 2012 Elsevier Ireland Ltd. All rights reserved.

1. Introduction

Trans-radial approach for coronary interventions has been shown toreduce access-site vascular complications (ASVC) compared to trans-femoral approach [1,2]. ASVC after trans-radial approach, despitebeing rare, may not be trivial as some of themmay cause compartmentsyndrome which is known to have serious clinical consequences [3].Yet, data regarding the optimal management of ASVC after trans-radial approach are lacking.

The aim of this study was to assess the outcome of ASVC occurringafter trans-radial approach for coronary interventions, in order to de-termine the best modality of diagnosis and treatment.

2. Methods

At our Institution, between May 2005 and January 2011, the occurrence as well asthe outcome of ASVC was prospectively assessed in patients undergoing trans-radial

, Italy. Tel.:+39 03494295290;

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anagement and timing of a(2012), doi:10.1016/j.ijcard.2

approach percutaneous coronary angiography or intervention. The collection of thepresented data was conceived and organized by the internal board of our Departmentto monitor the clinical impact of the introduction of radial approach as a standard ap-proach in our cath lab.

Demographic, clinical and procedural data were stored in a dedicated database(Cardio-planet V.3.0.8, Ebit Aet S.p.A, Genoa, Italy). In order to ensure the highest pos-sible quality of data entry, all data were checked twice. The completeness and accuracyof the data were verified first at the end of the procedure (first operator) and secondlyat the end of every month (second operator).

In keeping with the agreed internal guidelines, all patients undergoing percutane-ous coronary procedures were treated, unless contraindicated, with dual antiplatelettherapy (aspirin and clopidogrel) before catheterization. Glycoprotein IIb/IIIa inhibi-tors were routinely administered, in the absence of specific contraindications, in pa-tients with ST-elevation acute myocardial infarction, while in the remaining patientstheir use was chosen by the operator according to clinical yield and complexity ofthe target lesion. A minimum dose of 5000 UI unfractionated heparin was adminis-tered through the radial sheath at any procedure, and adjusted (through subsequentintravenous administrations of heparin) maintaining an activated clotting time be-tween 250 and 350 s during PCIs.

Before any procedure, the presence of a good radial collateral flow through theulnar artery was demonstrated by Allen test (hand color flushes between 5 and 10 safter ulnar compression release). In the case of absence of hand color flash at Allentest, a modified Allen test using a pulse oximeter placed on the thumb was performedto confirm good radial collateral flow through the ulnar artery (pulse persists in thethumb after radial compression).

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Table 1Clinical and procedural characteristics of patients with radial-related vascular complications.

Age 68±9Male gender 29 (51%)Risk factorsFamily history of ischemic heart disease 13 (23%)Diabetes mellitus 11 (19%)Hypertension 32 (56%)Hypercholesterolemia 29 (51%)Active smoking 6 (11%)

Clinical historyAcute coronary syndrome at presentation 13 (23%)Previous myocardial infarction 3 (5%)Previous PCI 11 (19%)Previous coronary surgery 10 (18%)Diagnostic coronary angiography 32 (52%)PCI 25 (44%)Right radial approach 44 (77%)Left radial approach 13 (23%)Crossover 17 (30%)to opposite radial artery 5 (9%)to femoral artery 12 (21%)

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During the study period, 12,665 transradial procedures were performed by interven-tional cardiologists experienced with the radial approach (>60% rate of trans-radial pro-cedures at study beginning) or by trainees under their supervision. Diagnostic procedureswere performed by a 5 or 6 French 25 cm Radifocus (Terumo, Japan) hydrophilic sheathswhile generally 6 French was adopted for coronary interventions. The arterial sheath waswithdrawn immediately after the procedure. A bandage made of a gauze pad and 3 adhe-sive elastic bands was used for compression. The bandage was slackened after 1 h andkept on for 4–6 h after procedures.

2.1. Vascular complications definitions, diagnosis and management

After the procedure, the occurrence of ASVC was prospectively recorded in the da-tabase by the first or second operator immediately after its occurrence. Patients withsuspected ASVC immediately underwent an instrumental investigation which includedarterial angiography of the segment with possible damage if ASVC was suspected dur-ing the procedure and by ultrasound evaluation if it was suspected after the procedure.All ultrasound evaluations were performed or reviewed by a vascular surgeon (GT).Other types of instrumental investigations were subsequently performed if deemednecessary.

ASVC were defined as any vascular damage requiring specific instrumental inves-tigations and included the following types:

1. local haematoma in the absence of detectable arterial wall damage (local accumu-lation of blood within the tissues forming a swelling and extending from access-site to forearm and arm);

2. pseudo-aneurysm (perforation of the arterial wall resulting in a pulsating hemato-ma that contains in communication with the arterial lumen);

3. vessel perforation (perforation of the artery wall with blood extravasation);4. arterial-venous fistula (abnormal connection between radial artery and a vein);5. arterial dissection (de-lamination between the outer and inner layers of the arterial

wall);6. compartmental syndrome (compression of nerves, blood vessels, and muscle inside

the upper limb compartments, leading to ischemic tissue necrosis);7. post-catheterization hand ischemia (occurrence of symptoms compatible with

hand ischemia)8. any other arterial damage or entry-site complication as mycotic aneurysm (bacteri-

al infection in the wall of an artery resulting in the formation of an aneurysm),access-site infections etc.

Asymptomatic post-catheterization radial artery occlusion was not considered anASVC nor was prospectively assessed.

ARVC were divided in three subgroups according to the timing of diagnosis asfollows:

- “very early”, diagnosis performed in the cath lab;- “early”, diagnosis performed after cath lab discharge but during hospital stay;- “late”, diagnosis performed after hospital discharge.

Conservative management was considered any management not requiring surgeryor blood transfusion. According to our internal guidelines, conservative managementof haemorrhagic complications of the upper arm included prolonged compressive ban-dage immediately after diagnosis followed by angiographic (in the case of diagnosisbefore procedure completion) or Doppler (in the remaining cases) re-evaluation.

All patients with ASVC were followed-up since diagnosis to hospital discharge toassess the need of surgery or blood transfusions. The patients with ASVC werefollowed-up after discharge by clinical visit or phone interview at 3 months after theindex procedure or after surgery to assess the occurrence of neurological hands defi-cits. Neurological hand deficits were graded on a scale from 0 (no movement of thehand) to 5 (muscle contraction normally against full resistance) according to MedicalResearch Council (MRC) Scale for Muscle Strength Medical Research Council [4].

2.2. Study end-points

The primary end-point of the study was the need for surgery after radial-approachrelated ASVC.

Secondary study end-point was the incidence of hand neurological deficit afterradial-approach related ASVC.

2.3. Statistical analysis

Continuous variables are presented as mean±standard deviation, and comparedusing the Student unpaired t test. Categorical variables are presented as counts andpercentages, and compared by means of Chi-square tests or Fisher exact test asappropriate.

3. Results

During the study period, 57 patients had ASVC and constituted thestudy population.

The clinical and procedural characteristics of the 57 patients withASVC are showed in Table 1. Briefly, 23% of patients had acute coronary

Please cite this article as: Burzotta F, et al, Management and timing of ataneous coronary procedures, Int J Cardiol (2012), doi:10.1016/j.ijcard.2

syndrome (unstable angina ormyocardial infarction) as clinical presen-tations and 44%of patients underwent coronary percutaneous interven-tions. The primary percutaneous approach was the right radial artery in77% and the left radial artery in 23% of cases. The crossover to a secondapproach occurred in 30% of patients with ASVC.

The diagnosis of ASVC was performed by upper limb angiographyin 25 (44%) patients and by Doppler in 32 (56%) patients.

The observed ASVC types were: 15 local haematomas (26%) in theabsence of documented specific vessel damage, 12 pseudo-aneurysms(21%), 10 radial artery perforations (18%), 9 artero-venous fistulas(16%), 6 radial artery dissections (11%); 2 compartment syndromes(3%); 1 transient hand ischemia (2%) and 2 mycotic aneurysms (3%).

The timingof ASVCdiagnosiswas: “very early” in 26 patients (46% ofASVC), “early” in 21 patients (37% of ASVC) and “late” in 10 patients(17% of ASVC). The timing of ASVC diagnosis didn't differed in the firstand second part of the study. Indeed, the “very early”, “early” and“late” diagnoses were performed respectively in 12, 14 and 3 cases dur-ing 2005–2008 vs 14, 7 and 7 cases during 2009–2011 (p=0.13).

The management of ASVC is summarized in Table 2 and comprisedsuccessful “conservative management” in 51 (89%) patients. The conser-vative management included compression with elastic bandage (32cases) and medical therapy (one patient with possible hand ischemiawho was successfully managed by heparin administration). No patientneeded blood transfusion. Six patients (11%) underwent vascular surger-y: urgent fasciotomy was needed in 2 patients with compartment syn-drome and elective surgery was performed in the remaining 4 patients(2 exhibiting pseudo-aneurysm and 2 exhibiting mycotic aneurysm).

At 3 months, mild (MRC Scale 4) neurological consequences werepresent in 3 (5%) patients; all of them received surgical intervention(1 due to compartment syndrome and 2 due to mycotic aneurysm).

Of note, the need for surgical management differed according tothe timing of diagnosis. Indeed, surgical treatment was necessary in1 of 26 patients (3.8%) with “very early” diagnosis, in 1 of 21 patients(4.8%) with “early” diagnosis, and in 4 of 10 patients (40%) with “late”diagnosis (p=0.026). Accordingly, the estimated odds ratio of needfor surgery in patients with “late” diagnosis (vs the remaining pa-tients) was 15 (95% confidence intervals: 2–100).

3.1. Management and outcome of specific ASVC types

3.1.1. Hematoma without evident vascular damageAccess-site hematoma requiring further diagnostic investigations

was the most frequent radial ASVC and occurred in 15 patients. In 4

ccess-site vascular complications occurring after trans-radial percu-012.05.017

Table 2Management of patients with radial-related vascular complications.

Modality of treatment No. of patients (%)

Conservative management 51 (89%)– Compression with elastic bandage. 32 (56%)– Conservative management without further treatment. 10 (18%)– Solved spontaneously in the cath lab at the end of procedures. 8 (14%)– Medical therapy (heparin). 1 (2%)Surgical management 6 (11%)

ACSV: access-site vascular complication.

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cases it was associated to a hemoglobin drop >3 g/dl (managed with-out blood transfusion).

Three hematomas were diagnosed “very early” and treated withlocal compression with elastic bandage for 4 h. The remaining 12 pa-tients had “early” diagnosis and Doppler ruled out artery perforation.Eight of them were treated with local compression with elastic ban-dage for 4 h, while 4 patients had conservative management withoutfurther treatment. In all patients, the hematoma's outline was markedwith a pen in order to easily check a further growth.

3.1.2. Pseudo-aneurysm (Fig. 1)Pseudo-aneurysm was the second most frequent radial ASVC as it

occurred in 12 patients. Diagnosis was “early” and “late” in 7 and 5patients, respectively. In 10 patients it was treated by local compres-sion with elastic bandage for 12 h. In 2 patients, both with “late” diag-nosis, pseudo-aneurysm persisted after repeated compression so thatelective surgical vascular repair was performed (Fig. 1).

3.1.3. Upper limb artery perforation (Fig. 2)Radial artery perforation occurred in 10 patients, was caused by

wire injury at the time of sheath insertion attempt and was always di-agnosed “very early” by angiography. In 5 patients, the operator de-cided to continue the procedure from the same access‐site, to crossthe perforation site and to place the long sheath across the damagedsegment. At the end of the procedure, repeated angiography aftersheath pullback revealed perforation sealing. In the remaining 5 pa-tients, the access was abandoned and 12 h compressive with elasticbandage was performed. None of these patients required blood trans-fusions, surgery nor had neurological consequences (Fig. 2).

3.1.4. Artero-venous fistulaRadial artero-venous fistula occurred in 9 patients. It was diagnosed

“very early” in 6 patients and “late” in 3 patients who complained ofpain and edema associated with local fremitus. In 3 patients with

Fig. 1. Pseudo-aneurysm. Clinical presentation

Please cite this article as: Burzotta F, et al, Management and timing of ataneous coronary procedures, Int J Cardiol (2012), doi:10.1016/j.ijcard.2

“very early” diagnosis the operator decided to continue the procedurefrom the same access, to cross the perforation site and to place thelong sheath across the damaged segment. At the end of the procedure,repeated angiography after sheath pullback revealed perforation sea-ling. In the remaining 3 patients with very early diagnosis, the accesswas abandoned and 12 h compressive with elastic bandage was per-formed. Finally, in the 3 patients with “late” diagnosis by Doppler,12 h compressive with elastic bandage was performed. Radial artero-venous fistula resolved in all cases and no blood transfusion, surgeryor neurological consequence was noted.

3.1.5. Upper limb artery dissectionA radial artery dissection was diagnosed “very early” in 6 patients

with angiography, performed after abnormal resistance perceivedduring guide-wire insertion. All of them were managed in the cathlab with no need of further therapy, as the dissection remained stablewithout complications at the end of procedure and throughout thefollow-up period.

3.1.6. Compartment syndrome (Fig. 3)Compartment syndrome occurred in 2 patients and was diagnosed

“very early” (at the end of a long interventional procedure) in onecase (Fig. 3 and “early” (in the first post-procedural day) in theother one. Both patients were managed by urgent surgery, and theone with “early” diagnosis had mild neurological consequences con-sisting of mild motor deficit of the hand (MRC grade 4).

3.1.7. Hand ischemiaOne patient had “early” diagnosis of (transient) hand ischemia.

The patient complained of pain and paresthesia possibly because ofischemia of the hand. Doppler evaluation revealed radial artery occlu-sion and concomitant atherosclerotic sub-occlusion of the ulnar ar-tery. Insufficient collateral circulation from the ulnar artery and/ordistal embolism was suspected and he was treated by two subcutane-ous administrations of low-molecular weight heparin (12 h apart)and the symptoms disappeared. No further Doppler evaluation wasperformed.

3.1.8. Mycotic aneurysmMycotic aneurysm occurred in 2 (diabetic) patients. Both of them

were diagnosed “late” and required vascular surgery. Both patientsreported mild neurological consequences, consisting of mild motordeficit of the hand (MRC grade 4) probably due to nerve injury causedby the infective process.

of a pseudo-aneurysm with late diagnosis.

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Fig. 2. Upper limb artery perforation. Panel A. Angiography immediately after attempt to advance the wire into the radial-brachial axis: an important perforation is documented inthe proximal radial and distal brachial artery with blood extravasation at two sites (black arrows). The operator decided to continue the procedure through the same route bygaining the true lumen with a wire and placing a long (25 cm sheath) across the lesion. At the end of procedure, before sheath removal, vessel sealing was confirmed by angiog-raphy. Yet, due to the blood extravasation occurred at procedure beginning, the patient developed a mild upper limb hematoma concentrated in two sites (black arrows) (Panel B).

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4. Discussion

The present study assessing the outcome and management of alarge series of patients with ASVC after trans-radial approach showsthat:

1. the majority of ASVC may successfully be treated by conservativemanagement.

2. “late” diagnosis is significantly associated with the need for surgi-cal correction.

Trans-femoral approach is still themost used approach for coronaryinterventions. Yet the trans-radial approach is increasing its penetrationbecause it is associated to a significant reduction of ASVC and faster pa-tient mobilization. Furthermore, ASCV after trans-femoral approach aremost often clinically relevant with prolonged hospital stay, blood trans-fusions or surgical procedures, or even death [5–8].

Data regarding the outcome and optimal management of ASVCafter trans-radial approach are lacking. Thus, we designed the presentstudy in order to assess the optimal management of patients with ra-dial ASVC. The observed results show that ASVC are generally associ-ated to a good clinical outcome. Indeed, in our case series, no patientderived life-threatening consequences, only 11% required vascularsurgery and 5% only had (mild) neurological deficit on the hand.Such findings compare favorably as expected with outcomes of femo-ral artery ASVC with surgery and mortality rates reported up to 25and 1%, respectively [9,10].

Among the factors which may limit the clinical consequences ofradial-related ASVC, the relevance of prompt recognition is stronglysupported by our study (showing that the need of surgical correctionis 15-fold higher in patients with “late” ASVC diagnosis). In our centerprompt diagnosis of ASVC is achieved by performing angiography ifthe complication occurs during the procedure and Doppler ultra-sound if it is suspected post-procedure. Thereafter, conservative man-agement without intervention has been successfully reserved toarterial dissections and to hematomas. Patients with documentationof “hemorrhagic” complications like perforations, pseudo-aneurysmsor artero-venous fistula have been mainly treated by prolonged

Please cite this article as: Burzotta F, et al, Management and timing of ataneous coronary procedures, Int J Cardiol (2012), doi:10.1016/j.ijcard.2

compressive bandage. Of note, when vessel damage was diagnosedduring the procedure, crossover to the contralateral radial or femoralaccess was decided and “external” hemostasis by a compressive ban-dage was performed. Only in selected cases, the operator decided tocross the lesion with the wire and to achieve “internal” hemostasisby introducing a long sheath inside the artery across the vasculardamage [11,12]. As a part of our approach, instrumental re-evaluation of the outcome of the vascular damage was planned inall cases. Such “active” conservative management probably allowedus to avoid both surgery and neurological consequences in the major-ity of the patients with “hemorrhagic” complications.

In contrast, an established compartment syndrome requires ur-gent vascular surgery [13]. In our study, two patients had compart-ment syndrome and were managed by urgent surgery obtaining inone case an excellent outcome. In the other case, the diagnosis wasnot immediate and neurological deficit persisted despite surgery.This observation reinforces the relevance of careful surveillanceafter trans-radial approach procedures in order to have prompt diag-nosis and management for this rare but dreadful complication [14].

In our series, radial-related mycotic aneurysm, previously reportedas a serious complications after arterial catheterizations [15], was a“late” complication in two patients and had to be treated surgically.Due to the rarity and potential multiple mechanisms underlining thedevelopment ofmycotic aneurysms, it is difficult to prevent their occur-rence. Nevertheless, mycotic aneurysm occurrence should be alwayssuspected whenever a patient comes late back with a septic syndromeafter catheterization. After appropriate antibacterial therapy, vascularsurgery was needed in both patients to remove the septic focus. No re-currence of septic events was noted, but both patients had neurologicalconsequences probably due to the direct infective damage of handnerves.

Finally, although the Allen test [16] was systematically performed inall our patients prior to radial artery puncture, one of our patients com-plained transient symptoms of hand ischemia. The exact cause for thiscomplication was not established as both distal embolization or symp-tomatic radial artery thrombosis [17] may have been occurred. Never-theless, as both events (symptomatic radial artery thrombosis and

ccess-site vascular complications occurring after trans-radial percu-012.05.017

Fig. 3. Compartment syndrome. Panel A. Upper limb angiography in a patient who developed compartment syndrome during a long coronary procedure. In the angiographyobtained at the end of the procedure, compression of radial and ulnar artery (arrow) is noted. The patient underwent immediate surgical fasciotomy (Panel B) obtaining completeneurological recovery.

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distal embolization) are basically thrombotic events, we decided to ad-minister low-molecular weight heparin [18] and symptoms resolutionwas noted.

5. Study limitations

This study has several limitations.First, the study is a single centre registry so that only a restricted

number of interventional cardiologists with high experience with ra-dial approach were involved. As a consequence, the reported resultsmay be influenced by the local organization and may not be immedi-ately applicable to centers with low trans-radial experience.

Second, possible predictive factors for the occurrence of complica-tions have not been assessed so that the study cannot improve theknowledge on the possible patient-related (age, gender, etc.) orprocedure-related (duration, devices used) risk factors for ASVC.

Third, as some ASVC may have late clinical presentation, ASVCunderreporting (in particular for those with late presentation afterhospital discharge) cannot be discarded.

Please cite this article as: Burzotta F, et al, Management and timing of ataneous coronary procedures, Int J Cardiol (2012), doi:10.1016/j.ijcard.2

Fourth, hematomas were under reported in this study as only he-matomas requiring specific instrumental investigations were consid-ered. Moreover, their exact location (at the site of puncture or in thearm/forearm proximal to the puncture site) and extension was notprospectively recorded.

Fifth, asymptomatic radial artery occlusion was not prospectivelyassessed so that the late consequences of this vascular complicationwere not investigated.

Finally, the neurological outcome of ASVC was investigated using aclinical grading only as nerve conduction studies were not systemat-ically performed. As a consequence, the accuracy of nerve damage as-sessment is limited.

6. Conclusions

The results of the present study show that ASVC in patients under-going trans-radial approach are rarely associated to the need for vas-cular surgery and to neurological consequences.

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Prompt diagnosis and a conservative approach may allow success-ful non-invasive management in the majority of cases.

Financial disclosures

The authors declare that they have no competing interests.

Funding/support

The authors declare that there were no founding source for thisstudy.

Acknowledgment

The authors of this manuscript have certified that they complywith the Principles of Ethical Publishing in the International Journalof Cardiology [19].

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