Abstract
Background
Radial access for primary percutaneous coronary intervention (PPCI) is well established in terms of safety and efficacy. However , there are limited data on the impact of the use of a single dedicated radial guide catheter in primary PCI using radial access.
Aims
To determine the overall cardiac catheterisation laboratory to balloon time (CCL2BT) and door to balloon (D2BT) time in transradial PPCI. To determine the impact of a single dedicated radial guide catheter on CCLD2BT and D2BT in transradial PPCI compared to conventional transfemoral PPCI.
Methods
The procedural and clinical outcomes of consecutive patients who had transradial primary PCI between 2005 and 2009 were included in this study and compared with a matched cohort who underwent transfemoral primary PCI.
Results
Overall D2BT and inpatient MACE were similar between the radial (n = 53) and femoral (n = 53) groups (85 and 82 min, P = 0.889; 0% and 1.8% P = 0.317 respectively). An increase in the CCL2BT and procedural times was noted in the radial compared to the femoral group (34 min versus 29 min P = 0.028; 15.8 min versus 11.6 min P = 0.001). When a single radial guide catheter was used for the entire procedure, there was no difference in CCL2BT, D2BT and procedural times between the radial and femoral groups (31 min versus 29 min P = 0.599; 74 min versus 82 min P = 0.418; 50 min versus 47 min P = 0.086).
Conclusion
The radial approach is safe and results in guideline recommended D2BT in STEMI. The use of a dedicated radial guide catheter reduces treatment time, demonstrating equivalent times to a femoral approach.
1
Introduction
The radial artery has gained popularity as an alternative vascular access site given the faster mobilization of patients, quicker discharge and greater patient satisfaction compared to femoral access for coronary interventions . In addition, access site complications are significantly less with transradial coronary intervention (TRCI) . TRCI is also associated with significant cost reduction compared to transfemoral coronary intervention . In ST elevation myocardial infarction (STEMI), TRCI has been shown to be feasible and safe even in patients at high risk for complications such as the elderly . These benefits may be magnified in the era of contemporary percutaneous coronary intervention (PCI) practice with increasing complexity of antithrombotic regimens . There are concerns, however, that these benefits may be offset by the presumed delay involved in transradial procedures, compounded further by the steep learning curve involved in TRCI . Other potentially confounding issues relate to puncture failure, vasospasm, subclavian artery tortuosity and angulations of the brachiocephalic artery. There are also concerns regarding device selection for TRCI in complex lesion subsets that may potentially prolong procedural time further. There are limited data on the impact of transradial infarct coronary intervention on procedural times, especially door to balloon time (D2BT) and cardiac catheter laboratory to balloon times (CCL2BT). We report the safety, efficacy and procedural times of an unselected group of patients undergoing PPCI via the radial approach compared to the femoral approach in a high volume PCI center. In addition we aimed to study the usefulness and efficacy of a single, dedicated radial guide catheter for both the diagnostic angiogram and coronary intervention and its effect on procedural times.
2
Methods
In January 2005, we started our complex transradial PCI program. In the early stages of this program, a single experienced transradial operator (who had performed more than 500 transradial PCI’s including 100 complex PCI’s) performed all the primary PCIs. Within this patient group, from January 2005 to December 2009, we conducted a retrospective cohort study of consecutive patients who underwent PPCI via the radial approach. These patients were age, sex, and infarct related artery matched against a control group who had PPCI via a femoral approach during the same period. The femoral group included patients who had PPCI performed in the same institution by six other experienced interventional cardiologists. All patients presented within 12 h from the onset of chest pain. Patients with cardiogenic shock, previous coronary artery bypass graft surgery, negative Allen’s test or Type C/D ulnar collateral flow by plethysmographic assessment or those referred for rescue angioplasty, were excluded from the study. Prior to PPCI, all patients underwent coronary angiography in accordance with established institutional protocols. A left coronary system angiogram was performed in three to four projections and the right coronary system angiogram completed in two or three projections. Left ventriculography was left to the discretion of the operator, to be performed before or after PCI. All data apart from the puncture time, CCL2BT and D2BT for the RICI group were collected retrospectively in both groups from the institutional PCI database and a review of medical records. The use of glycoprotein IIb–IIIa inhibitors (GPI) was left to the discretion of the operator. The first 14 RICI diagnostic procedures were performed using a radial diagnostic catheter (TIGER, Terumo Corp, Japan) and the PCI performed using appropriate guide catheters. In the subsequent 39 RICI procedures, a dedicated radial guide catheter (Kimny, Boston Scientific Scimed) was used. Standard Judkins diagnostic and guide catheters were used in the femoral access cohort.
The study was undertaken as part of an ongoing audit to assess the safety and efficacy of transradial coronary intervention in acute myocardial infarction. Institutional ethics committee approval was obtained. The procedures were performed in accordance with the approved departmental operational protocol for transradial coronary interventions.
2.1
Radial approach — Description of procedure
Standard informed consent was obtained from all patients. The right radial artery was accessed in all 53 patients. Plethysmographic assessment or Allen’s test was employed to assess the integrity of the ulnar collaterals of the right hand. Patients who had a negative Allen’s test or type A/B trace of the plethysmographic test were considered suitable for TRCI. The plethysmographic assessment of the ulnar collateral flow of the hand has been previously described . Briefly, a pulse oximeter is applied to the right thumb. The radial artery is compressed and the plethysmographic trace of the O2 saturation of the thumb is observed. In a Type A, trace there is no attenuation of the amplitude of the trace. In Type B, the amplitude of the trace is attenuated throughout the duration of the occlusion of the radial artery. In Type C, the trace disappears on occlusion of the radial artery but reappears within 1–2 min but is attenuated in amplitude. In Type D, the trace disappears on occlusion of the radial artery and does not reappear. An open needle technique using a 21 G Cordis® transradial needle was used for radial artery puncture. A Cordis® hydrophilic transradial sheath (11 cm) was used to cannulate the radial artery. A spasmolytic cocktail of heparin 5000 U, 50–100 μg of glyceryl trinitrate and 1–2 mg Verapamil was administered into the radial artery. Right coronary artery lesions were treated using a 6 French Kimny (Boston Scientific Scimed), AR 1 or AR 2 guide catheters. Left coronary system lesions were treated using 6 French Kimny, EBU 3.5 or EBU 4.0 guide catheters. After PCI, the radial sheath was removed immediately and a pressure bandage applied with a tourniquet that was released 4 h later.
2.2
Femoral approach — Description of procedure
The femoral approach involved the standard “Judkins” approach. In our institution, we routinely use six French catheters except in bifurcation lesions where the catheter is upsized to a 7 French guide catheter. The femoral sheath is usually removed 3–4 h from the time of heparin administration. Arterial closure device usage was at the discretion of the operator.
2.3
Definitions
Puncture time — Time from infiltration of local anaesthesia to the insertion of sheath.
Procedure time — Time from patient’s entry into the cardiac catheterization laboratory to the end of procedure.
Fluoroscopy time — Total duration of radiation during the procedure.
Cardiac catheterization laboratory to balloon time ( CCL2BT ) — Time from patient’s entry into the catheterization laboratory to the time of the first balloon inflation.
Door to balloon time (D2BT) — Time from patient’s entry to the emergency department to the time of first balloon inflation.
2.4
Coronary intervention
Additional heparin could be administered to keep the activated clotting time > 250 s. GPI use and type of stent implanted were left to the discretion of the operator. Final TIMI flow was recorded in all patients. Procedural success was defined as < 30% residual lesion following stenting with TIMI 3 flow in the infarct related artery (IRA) territory.
2.5
Outcome measures
Primary outcome measures were procedural success, usefulness of a single dedicated radial guide catheter in PPCI in the reduction of D2BT, CCL2BT, procedural and fluoroscopy time. We feel that CCL2BT is a better reflection of procedural efficiency in infarct angioplasty. Secondary outcome measures were in-hospital mortality, major adverse cardiac and cerebrovascular events, access site complications and length of stay.
2.6
Statistical analyses
Data were analysed retrospectively and are expressed as median values. The Mann–Whitney U test was used to compare time data. A Chi-square test was used for categorical variables and the independent sample t-test was used for comparison of continuous variables. A P value of < 0.05 was deemed significant .
2
Methods
In January 2005, we started our complex transradial PCI program. In the early stages of this program, a single experienced transradial operator (who had performed more than 500 transradial PCI’s including 100 complex PCI’s) performed all the primary PCIs. Within this patient group, from January 2005 to December 2009, we conducted a retrospective cohort study of consecutive patients who underwent PPCI via the radial approach. These patients were age, sex, and infarct related artery matched against a control group who had PPCI via a femoral approach during the same period. The femoral group included patients who had PPCI performed in the same institution by six other experienced interventional cardiologists. All patients presented within 12 h from the onset of chest pain. Patients with cardiogenic shock, previous coronary artery bypass graft surgery, negative Allen’s test or Type C/D ulnar collateral flow by plethysmographic assessment or those referred for rescue angioplasty, were excluded from the study. Prior to PPCI, all patients underwent coronary angiography in accordance with established institutional protocols. A left coronary system angiogram was performed in three to four projections and the right coronary system angiogram completed in two or three projections. Left ventriculography was left to the discretion of the operator, to be performed before or after PCI. All data apart from the puncture time, CCL2BT and D2BT for the RICI group were collected retrospectively in both groups from the institutional PCI database and a review of medical records. The use of glycoprotein IIb–IIIa inhibitors (GPI) was left to the discretion of the operator. The first 14 RICI diagnostic procedures were performed using a radial diagnostic catheter (TIGER, Terumo Corp, Japan) and the PCI performed using appropriate guide catheters. In the subsequent 39 RICI procedures, a dedicated radial guide catheter (Kimny, Boston Scientific Scimed) was used. Standard Judkins diagnostic and guide catheters were used in the femoral access cohort.
The study was undertaken as part of an ongoing audit to assess the safety and efficacy of transradial coronary intervention in acute myocardial infarction. Institutional ethics committee approval was obtained. The procedures were performed in accordance with the approved departmental operational protocol for transradial coronary interventions.
2.1
Radial approach — Description of procedure
Standard informed consent was obtained from all patients. The right radial artery was accessed in all 53 patients. Plethysmographic assessment or Allen’s test was employed to assess the integrity of the ulnar collaterals of the right hand. Patients who had a negative Allen’s test or type A/B trace of the plethysmographic test were considered suitable for TRCI. The plethysmographic assessment of the ulnar collateral flow of the hand has been previously described . Briefly, a pulse oximeter is applied to the right thumb. The radial artery is compressed and the plethysmographic trace of the O2 saturation of the thumb is observed. In a Type A, trace there is no attenuation of the amplitude of the trace. In Type B, the amplitude of the trace is attenuated throughout the duration of the occlusion of the radial artery. In Type C, the trace disappears on occlusion of the radial artery but reappears within 1–2 min but is attenuated in amplitude. In Type D, the trace disappears on occlusion of the radial artery and does not reappear. An open needle technique using a 21 G Cordis® transradial needle was used for radial artery puncture. A Cordis® hydrophilic transradial sheath (11 cm) was used to cannulate the radial artery. A spasmolytic cocktail of heparin 5000 U, 50–100 μg of glyceryl trinitrate and 1–2 mg Verapamil was administered into the radial artery. Right coronary artery lesions were treated using a 6 French Kimny (Boston Scientific Scimed), AR 1 or AR 2 guide catheters. Left coronary system lesions were treated using 6 French Kimny, EBU 3.5 or EBU 4.0 guide catheters. After PCI, the radial sheath was removed immediately and a pressure bandage applied with a tourniquet that was released 4 h later.
2.2
Femoral approach — Description of procedure
The femoral approach involved the standard “Judkins” approach. In our institution, we routinely use six French catheters except in bifurcation lesions where the catheter is upsized to a 7 French guide catheter. The femoral sheath is usually removed 3–4 h from the time of heparin administration. Arterial closure device usage was at the discretion of the operator.
2.3
Definitions
Puncture time — Time from infiltration of local anaesthesia to the insertion of sheath.
Procedure time — Time from patient’s entry into the cardiac catheterization laboratory to the end of procedure.
Fluoroscopy time — Total duration of radiation during the procedure.
Cardiac catheterization laboratory to balloon time ( CCL2BT ) — Time from patient’s entry into the catheterization laboratory to the time of the first balloon inflation.
Door to balloon time (D2BT) — Time from patient’s entry to the emergency department to the time of first balloon inflation.
2.4
Coronary intervention
Additional heparin could be administered to keep the activated clotting time > 250 s. GPI use and type of stent implanted were left to the discretion of the operator. Final TIMI flow was recorded in all patients. Procedural success was defined as < 30% residual lesion following stenting with TIMI 3 flow in the infarct related artery (IRA) territory.
2.5
Outcome measures
Primary outcome measures were procedural success, usefulness of a single dedicated radial guide catheter in PPCI in the reduction of D2BT, CCL2BT, procedural and fluoroscopy time. We feel that CCL2BT is a better reflection of procedural efficiency in infarct angioplasty. Secondary outcome measures were in-hospital mortality, major adverse cardiac and cerebrovascular events, access site complications and length of stay.
2.6
Statistical analyses
Data were analysed retrospectively and are expressed as median values. The Mann–Whitney U test was used to compare time data. A Chi-square test was used for categorical variables and the independent sample t-test was used for comparison of continuous variables. A P value of < 0.05 was deemed significant .
3
Results
3.1
Baseline characteristics
From January 2005 to December 2009, a total of 1480 patients underwent infarct angioplasty in our centre. One hundred and six patients undergoing primary infarct angioplasty were included in our study (n = 53 radial group, n = 53 femoral group). One operator performed transradial infarct angioplasty in our centre until February 2009. The baseline patient characteristics are shown in Table 1 . The radial patients were an unselected group, including complex lesion subsets, reflecting real world patients.
| Radial (n = 53) | Femoral (n = 53) | P value | |
|---|---|---|---|
| Age (years) | 58.72 ± 12.3 | 58.58 ± 12.0 | 0.824 |
| BMI | 28.48 ± 4.9 | 27.28 ± 5.6 | 0.287 |
| Male | 44 (83.0%) | 44 (83.0%) | 1.000 |
| Risk Factors | |||
| Hypertension | 24 (45.3%) | 23 (43.4%) | 0.845 |
| Diabetes | 6 (11.3%) | 8 (15.1%) | 0.566 |
| Smoking | 30 (56.6%) | 28 (52.8%) | 0.696 |
| Hyperlipidemia | 21 (39.6%) | 23 (43.4%) | 0.693 |
| Family History | 10 (18.9%) | 19 (35.8%) | 0.050 |
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