Abstract
Background
The growing number of complex endovascular procedures is expected to increase the risk of iatrogenic injuries of peripheral arteries. A strategy of percutaneous transluminal angioplasty (PTA) with covered stent (CS) may represent a valuable alternative to open surgery. However, systematic evaluations of CS in this setting represent a scientific gap. In the present study, we investigate the procedural and clinical outcomes associated with PTA and CS implantation to repair iatrogenic injuries of peripheral arteries.
Methods
All patients undergoing PTA with CS for endovascular repair of iatrogenic injuries of peripheral arteries between August 2010 and July 2013 at our Institution were retrospectively analyzed. The primary endpoint was the technical success. Secondary endpoints were in-hospital mortality and cumulative death, target lesion revascularization (TLR), amputation and major stroke at 12-month follow-up.
Results
During the period of observation, a total of 30 patients underwent PTA with either self-expandable (43.3%) or balloon-expandable CS (56.7%) for iatrogenic injuries of peripheral arteries. Injuries consisted of perforation/rupture (76.7%), arteriovenous fistula (16.7%) and pseudoaneurysm (6.7%) of iliac–femoral arteries. Technical success was achieved in all cases. Median follow-up was 409 days [210–907]. The incidence of in-hospital mortality was 10.0%. At 12-month follow-up, the incidence of death, TLR, amputation and major stroke was 20.0%, 17.0%, 3.3% and 6.7%, respectively.
Conclusion
The use of covered stents for endovascular repair of iatrogenic injuries of peripheral arteries shows a high technical success and may be alternative to surgery. Further studies with larger populations are needed to confirm these preliminary findings.
Highlights
- •
The growing number of complex endovascular procedures is expected to increase the risk of iatrogenic injuries of peripheral arteries.
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Percutaneous transluminal angioplasty with covered stent has been proposed as alternative to open surgery in this setting.
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In this study the use of covered stents shows a high technical success and good 12-month durability in terms of both, efficacy and safety.
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It is suggested that endovascular repair can be attempted in a broad spectrum of patients with positive results.
1
Introduction
The growing number of percutaneous procedures managing a wide spectrum of cardiovascular diseases is expected to increase the incidence of iatrogenic vascular injuries . In this regard, as long the femoral artery remains the dominant form of vascular access , the iliac–femoral axis represents the district exposed to the highest risk of iatrogenic arterial injuries. The most frequent injuries occurring in this vascular bed are rupture, perforation, pseudoaneurysm and arteriovenous fistula .
Open surgical repair has been for a long time the therapy of choice for iatrogenic injuries of peripheral arteries with a high technical success . However, in the daily practice the clinical presentation and the burden of comorbidities of patients with iatrogenic injuries of peripheral arteries seriously challenge this option . Indeed, in patients presenting unstable conditions a surgical repair of arterial injuries may potentially increase cardiac damage . Moreover, secondary complications after surgery such as hematoma and local tissue injury frequently predispose to poor wound healing and postoperative infection .
Percutaneous transluminal angioplasty (PTA) with covered stent (CS) has been proposed as alternative to open surgery in this setting: the possibility to perform stenting under local anesthesia and the wide accessibility to PTA-facilities represent arguments supportive of endovascular approach as compared with open surgery. However, systematic evaluations of CS in this setting still represent a scientific gap . Thus, the present study investigates procedural and clinical outcomes of patients treated with PTA with CS implantation for iatrogenic injuries of peripheral arteries in a consecutive cohort of patients undergoing percutaneous procedures.
2
Methods
2.1
Patient population
The institutional database of Deutsches Herzzentrum , Klinik an der Technischen Universität München — Munich , Germany was retrospectively searched for patients undergoing PTA with CS to repair iatrogenic injuries of peripheral arteries between August 2010 and July 2013.
After a diagnostic or interventional percutaneous procedure, the clinical suspect of iatrogenic injury of a peripheral artery was verified by means of non-invasive imaging. According to standard institutional protocol , after a diagnostic or interventional percutaneous procedure [day 0] all patients were clinically examined and evaluated for typical signs of arterial injury. Color Doppler ultrasonography (DUS) was routinely performed the day after index procedure [day 1].Those patients presenting the clinical suspect of iatrogenic injury of a peripheral artery (i.e. in case of hemoglobin-drop, hematoma, pain, swelling, and a pulsatile mass or bruising at the puncture site), in stable clinical conditions, without signs of impaired hemodynamic status or active bleeding were referred for DUS or computed-tomography angiography at any time after the procedure. The decision to perform DUS rather than computed-tomography angiography was based on accessibility to imaging techniques of suspected injured vessels and clinical status.
In all cases the diagnosis was confirmed with selective digital subtraction angiography of the injured artery. In patients who bled as a consequence of the arterial injury, bleeding was graded according to Bleeding Academic Research Consortium (BARC) criteria . In those patients with multiple injuries treated simultaneously in the same procedure the worst injury was entered in the current analysis as representative for that patient.
2.2
Follow-up and data management
All patients underwent follow-up by means of clinical visit at the same hospital or telephone contact. DUS or angiography served to evaluate the stented segments after PTA. As per institutional protocol, all patients receiving a PTA were scheduled for clinical visit and DUS of the treated segments between 3 and 9 months after index procedure or at any time in case of any complaint. Those patients scheduled for invasive procedures (either peripheral or not) between 3 and 9 months after PTA received a control angiography of the stented segment, with or without DUS.
In case of an adverse event at another center, medical records or discharge letters from other institutions were systematically reviewed. General practitioners and referring physicians were contacted for additional information, if necessary. Relevant clinical data were collected and verified against source documentation. For the current analysis, data of all patients included in the registry were transferred to the ISAR-Research Center ( Deutsches Herzzentrum München , Klinik an der Technischen Universität München — Munich , Germany ). The final dataset was checked for completeness and consistency.
2.3
Endpoints definitions
The primary endpoint was the technical success, defined as the absence of any blood loss (contrast medium extravasation in the case of vessel perforation or rupture) or the complete exclusion of the pathological communication (in the case of arteriovenous fistula or pseudoaneurysm) confirmed at digital subtraction angiography after CS implantation, without acute deterioration of clinical status or the need for urgent surgical conversion. Secondary endpoints were in-hospital death, as well as cumulative death, target lesion revascularization (TLR), amputation and major stroke at 12-month follow-up. Death was supposed to be cardiac unless a clear non-cardiac cause could be identified. TLR was defined as any clinically indicated repeat revascularization (percutaneous or surgical) due to a > 50% re-narrowing (at DUS or angiography) in the stented-segment including 5 mm beyond the treatment segment proximally and distally, or due to clinical or instrumental signs of leakage at the level of the stented segment. Amputation was defined as any major and minor amputation of the treated limb. Major stroke was defined as any neurological deficit of cerebrovascular cause persisting > 24 hours or interrupted by death < 24 hours.
2.4
Statistical analysis
Continuous variables are presented as median [25th; 75th percentile] or mean ± standard deviation, whereas categorical variables are presented as numbers and percentages. The normality of distribution of continuous variables was evaluated by the Kolmogorov–Smirnov goodness-of-fit test, and therefore compared with independent sample Student t or Mann–Whitney U test. Categorical variables were compared with χ 2 statistic or Fisher-exact test.
The American College of Surgeons—National Surgical Quality Improvement Program (ACS-NSQIP) score summarized the risk profile of patients included . The ACS-NSQIP score uses a total of 22 preoperative patient risk factors together with the intrinsic risk of the surgical procedure to estimate patient-specific postoperative complication risks. For the purpose of the present analysis, for each patient the risk of 30-day mortality according to ACS-NSQIP score was estimated assuming that arterial injuries have undergone a surgical repair.
Results were displayed for the entire population, as well as divided per injury location: two anatomical regions were identified taking the inguinal ligament as a reference. Injuries above the inguinal ligament were designated as above the groin, and lesions below the inguinal ligament were designated as below the groin. Additionally, two exploratory analyses investigated the occurrence of death and TLR at 12-month follow-up according to the clinical presentation at the time of PTA (serious or life-threatening clinical status requiring prompt intervention, [urgent]/staged or planned intervention, [elective]), the type of CS used (self-expandable, [SE]/balloon-expandable, [BE]) or the presence of peripheral artery disease (PAD, yes/no).
2
Methods
2.1
Patient population
The institutional database of Deutsches Herzzentrum , Klinik an der Technischen Universität München — Munich , Germany was retrospectively searched for patients undergoing PTA with CS to repair iatrogenic injuries of peripheral arteries between August 2010 and July 2013.
After a diagnostic or interventional percutaneous procedure, the clinical suspect of iatrogenic injury of a peripheral artery was verified by means of non-invasive imaging. According to standard institutional protocol , after a diagnostic or interventional percutaneous procedure [day 0] all patients were clinically examined and evaluated for typical signs of arterial injury. Color Doppler ultrasonography (DUS) was routinely performed the day after index procedure [day 1].Those patients presenting the clinical suspect of iatrogenic injury of a peripheral artery (i.e. in case of hemoglobin-drop, hematoma, pain, swelling, and a pulsatile mass or bruising at the puncture site), in stable clinical conditions, without signs of impaired hemodynamic status or active bleeding were referred for DUS or computed-tomography angiography at any time after the procedure. The decision to perform DUS rather than computed-tomography angiography was based on accessibility to imaging techniques of suspected injured vessels and clinical status.
In all cases the diagnosis was confirmed with selective digital subtraction angiography of the injured artery. In patients who bled as a consequence of the arterial injury, bleeding was graded according to Bleeding Academic Research Consortium (BARC) criteria . In those patients with multiple injuries treated simultaneously in the same procedure the worst injury was entered in the current analysis as representative for that patient.
2.2
Follow-up and data management
All patients underwent follow-up by means of clinical visit at the same hospital or telephone contact. DUS or angiography served to evaluate the stented segments after PTA. As per institutional protocol, all patients receiving a PTA were scheduled for clinical visit and DUS of the treated segments between 3 and 9 months after index procedure or at any time in case of any complaint. Those patients scheduled for invasive procedures (either peripheral or not) between 3 and 9 months after PTA received a control angiography of the stented segment, with or without DUS.
In case of an adverse event at another center, medical records or discharge letters from other institutions were systematically reviewed. General practitioners and referring physicians were contacted for additional information, if necessary. Relevant clinical data were collected and verified against source documentation. For the current analysis, data of all patients included in the registry were transferred to the ISAR-Research Center ( Deutsches Herzzentrum München , Klinik an der Technischen Universität München — Munich , Germany ). The final dataset was checked for completeness and consistency.
2.3
Endpoints definitions
The primary endpoint was the technical success, defined as the absence of any blood loss (contrast medium extravasation in the case of vessel perforation or rupture) or the complete exclusion of the pathological communication (in the case of arteriovenous fistula or pseudoaneurysm) confirmed at digital subtraction angiography after CS implantation, without acute deterioration of clinical status or the need for urgent surgical conversion. Secondary endpoints were in-hospital death, as well as cumulative death, target lesion revascularization (TLR), amputation and major stroke at 12-month follow-up. Death was supposed to be cardiac unless a clear non-cardiac cause could be identified. TLR was defined as any clinically indicated repeat revascularization (percutaneous or surgical) due to a > 50% re-narrowing (at DUS or angiography) in the stented-segment including 5 mm beyond the treatment segment proximally and distally, or due to clinical or instrumental signs of leakage at the level of the stented segment. Amputation was defined as any major and minor amputation of the treated limb. Major stroke was defined as any neurological deficit of cerebrovascular cause persisting > 24 hours or interrupted by death < 24 hours.
2.4
Statistical analysis
Continuous variables are presented as median [25th; 75th percentile] or mean ± standard deviation, whereas categorical variables are presented as numbers and percentages. The normality of distribution of continuous variables was evaluated by the Kolmogorov–Smirnov goodness-of-fit test, and therefore compared with independent sample Student t or Mann–Whitney U test. Categorical variables were compared with χ 2 statistic or Fisher-exact test.
The American College of Surgeons—National Surgical Quality Improvement Program (ACS-NSQIP) score summarized the risk profile of patients included . The ACS-NSQIP score uses a total of 22 preoperative patient risk factors together with the intrinsic risk of the surgical procedure to estimate patient-specific postoperative complication risks. For the purpose of the present analysis, for each patient the risk of 30-day mortality according to ACS-NSQIP score was estimated assuming that arterial injuries have undergone a surgical repair.
Results were displayed for the entire population, as well as divided per injury location: two anatomical regions were identified taking the inguinal ligament as a reference. Injuries above the inguinal ligament were designated as above the groin, and lesions below the inguinal ligament were designated as below the groin. Additionally, two exploratory analyses investigated the occurrence of death and TLR at 12-month follow-up according to the clinical presentation at the time of PTA (serious or life-threatening clinical status requiring prompt intervention, [urgent]/staged or planned intervention, [elective]), the type of CS used (self-expandable, [SE]/balloon-expandable, [BE]) or the presence of peripheral artery disease (PAD, yes/no).
3
Results
Between August 2010 and July 2013, a total of 30 patients underwent endovascular repair for iatrogenic injuries of iliac–femoral arteries (above/below the groin, 43.3% and 56.7%, respectively) at our institution. Iatrogenic injuries occurred in the context of several diagnostic and interventional procedures: elective as well as urgent coronary intervention (13.3%); diagnostic coronary angiography (10.0%); percutaneous mitral valve repair with edge-to-edge clipping (13.3%); transfemoral aortic valve replacement (10.0%); central venous catheter placement (7.1%); and elective PTA (46.6%). Introducer sheath size at the time of arterial injury ranged between 6 and 24 French. In a large majority of patients (60%) a 7 French introducer sheath was used. A total of 7 patients (23.3%) received an introducer sheath size > 7 French. No data about the use of vascular closure device were available for the current analysis.
Baseline clinical characteristics are presented in Table 1 . Overall, patients presented with advanced age (71.0 years [68.0; 82.0]) and high frequency of diabetes (30.0%), multivessel coronary artery disease (73.3%) and symptomatic PAD (mean Rutherford class 2.03 ± 1.12). Antithrombotic therapies at the time of index PTA consisted of acetylsalicylic acid (93.3%), thienopyridines (93.3%) or oral anticoagulants (20.0%). There was no difference in the proportion of acetylsalicylic acid ( p = 0.18), thienopyridine ( p > 0.99) or oral anticoagulant therapies ( p = 0.19) between patients with above- versus below-the-groin injuries.
| Variable | Overall, n = 30 | Injury location | p | |
|---|---|---|---|---|
| Above the groin, n = 13 | Below the groin, n = 17 | |||
| Age (years) | 71 [68; 82] | 71 [68; 82] | 71 [68; 76] | 0.96 |
| Females (%) | 11 (36.7) | 4 (30.7) | 7 (41.2) | 0.70 |
| BMI (kg/m 2 ) | 26.1 [23.5; 28.2] | 24.2 [23.4; 27.3] | 26.8 [24.5; 29.7] | 0.19 |
| BMI > 30 kg/m 2 (%) | 4 (13.3) | 1 (7.7) | 3 (17.6) | 0.61 |
| Diabetes mellitus (%) | 9 (30.0) | 1 (7.7) | 8 (47.1) | 0.04 |
| Hypertension (%) | 25 (83.3) | 11 (84.6) | 14 (82.3) | > 0.99 |
| Hyperlipidemia (%) | 25 (83.3) | 9 (93.2) | 13 (76.5) | 0.35 |
| Current smoker (%) | 9 (30.0) | 4 (30.7) | 5 (29.4) | > 0.99 |
| CKD (%) | 12 (40.0) | 6 (46.1) | 6 (35.3) | 0.71 |
| Creatinine (mg/dl) | 0.9 [0.8; 1.3] | 0.9 [0.8; 1.3] | 1.1 [0.8; 1.3] | 0.28 |
| CAD (%) | 25 (83.3) | 11 (84.6) | 14 (82.3) | > 0.99 |
| ≥ 2 vessel disease | 22 (73.3) | 9 (69.2) | 13 (76.5) | 0.70 |
| Prior PCI (%) | 24 (80.0) | 11 (84.6) | 13 (76.5) | 0.67 |
| Prior CABG (%) | 4 (13.3) | 0 (0) | 4 (23.5) | 0.11 |
| LVEF < 35% (%) | 2 (6.7) | 1 (7.7) | 1 (5.9) | > 0.99 |
| PAD (%) | 18 (60.0) | 8 (61.5) | 10 (58.8) | > 0.99 |
| Rutherford class | 2.03 ± 1.12 | 2.07 ± 1.25 | 2.00 ± 1.06 | 0.98 |
| History of malignancy (%) | 6 (20.0) | 2 (15.4) | 4 (23.5) | 0.67 |
| Clinical presentation (%) | ||||
| Shock | 10 (33.3) | 7 (53.8) | 3 (17.6) | 0.056 |
| Urgent | 13 (43.3) | 7 (53.8) | 6 (35.3) | 0.31 |
| Stable | 17 (56.7) | 6 (46.1) | 11 (64.7) | 0.46 |
| ACS-NSQIP 30-day death (%) | 2.5 [1–16] | 2 [5–32] | 1 [1–4] | 0.02 |
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