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We aimed to evaluate the feasibility and safety of carotid artery stenting (CAS) with a newly designed double-layer micromesh stent using wrist approach in patients with significant carotid disease.Between January 2016 and December 2021, 105 patients undergoing CAS with Roadsaver™ stent were enrolled in a single center prospective study. Follow-up assessments included neurological exams, duplex ultrasound (DUS), and 12-lead ECG. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarction. Secondary endpoints included procedure success, access site complications, device success, target lesion revascularization, and in-stent restenosis evaluated with DUS. Long-term outcomes up to 72 months of follow-up were assessed in all eligible patients.The study population was predominantly male (69.5%) with a median age of 68 ± 8 years. Patients were symptomatic in 80% of the cases, and 35% fulfilled the high-risk criteria for surgical endarterectomy. The right internal carotid artery was the target artery in 56 (53.4%), and the left in 49 (46.6%) of the cases. All procedures were successfully completed from the right wrist, with right radial access in 94 (89.5%) cases and ulnar artery access with previous radial artery occlusion in 11 (10.5%) cases. All patients were treated successfully with the study device. The primary endpoint was met with a 30-day major adverse event rate of 0.9% (1/105). Up to 72 months of follow-up (median 30 ± 20 months) there were no strokes, neurological deaths, or target lesion revascularization of the treated lesion. Doppler ultrasound examination revealed nonsignificant in-stent restenosis in two asymptomatic patients. There was no hand ischemia detected in any patient.Results from this study demonstrate the radial and ulnar access for CAS with double layer micromesh Roadsaver™ stent is safe and feasible and associated with favorable early and long-term follow-up.

Objective The multicenter proximal upper limb artery (PULA) Registry was created to study the optimal puncture sites for the interventions involving the subclavian, axillary, and innominate arteries. Background Little is known about the optimal vascular access for PULA interventions, despite the well-known technical complexity of these procedures. Methods We performed the retrospective analysis of consecutive patients treated for symptomatic steno-occlusive disease of the proximal upper limb arteries between January 2015 and December 2019 in three high-volume centers. Acute thrombotic occlusions were excluded from the study. Results Two hundred and seventy-two patients were treated for significant stenosis and 108 for total occlusion. The baseline patient's characteristics were similar, except for the higher median age of the stenotic patients: 68.5 years (31.1; 90.0) versus 64 years (38.0; 86.0) p = 0.0015. Successful revascularization rate was higher in the stenotic group 93.75% (255/272) versus 86.11% (93/108) p = 0.0230, while the procedure length 27 min (8; 133) versus 46 min (7; 140) p = 0.0001 and fluoroscopy times 439 s (92; 2993) versus 864 s (86; 4176) p = 0.0001 were higher in the occlusion group. The main adverse event rate was similarly low. Dual access was used more often to treat occlusions (60.19% (65/108) vs. 11.40% (31/272) p = 0.0001) without significantly increasing the complication rate. The safest access was ultrasound-guided distal radial artery puncture, significantly better than conventional radial access with 0% (0/31) versus 13.6% (18/131) p = 0.0253 complication. Conclusions The percutaneous revascularization of proximal upper limb arteries is a safe and effective. Dual access can be applied to increase treatment efficacy, without significantly compromising safety.

Objectives To review the technical limitations of available pressure-wires, present the design evolution of a nitinol fiber-optic pressure wire and to summarize the First-in-Man (FIM) O2 pilot study results. Background Despite increasing use of physiology assessment of coronary lesions, several technical limitations persist. We present technical details, design evolution and early clinical results with a novel 0.014" nitinol fiber-optic based pressure-wire. Methods and results The 0.014' OptoWire™ (Opsens Medical, Quebec, Canada) was designed to combine improved handling properties compared to standard pressure-wires and to offer extremely reliable pressure recording and transmission due to fiber-optic properties compared to piezo-electric sensors and electrical wires. In vitro assessment showed that OptoWire™ steerability, pushability and torquability properties were closer to regular PCI wires than standard electrical pressure wires. In the First-in-Man O2 study, 60 patients were recruited at 2 centers in Canada. A total of 103 lesions were assessed with the OptoWire™ and OptoMonitor™, 75 lesions at baseline and 28 lesions post-PCI (without disconnection). In all crossed lesions (n = 100, 97%), mean Pd/Pa and FFR could be adequately measured. In 11 cases assessed successively with OptoWire™ and Aegis™ (Abbott Vascular, USA) bland-Altman analysis showed a mean difference of 0.002 ± 0.052 mmHg (p = .91) for Pd/Pa and 0.01 ± 0.06 for FFR calculation (p = .45). There was no device-related complication. Upon these initial results, several design changes aimed to improve overall performance including torquability, stiffness, resistance to kink and pressure drift were completed. Conclusion The novel 0.014" fiber-optic OptoWire™ provides superior wire handling with reduced risk of pressure drift allowing reliable pre- and post-PCI physiology assessment.

Objectives To gain insight into current practice of transradial angiography and intervention in the United States and around the world. Background Transradial access (TRA) has grown worldwide. In a prior survey, there was significant practice variation and there was minimal US participation which limited the generalizability to US operators. Methods We used an internet-based survey software program to solicit input from practicing interventional cardiologists from the United States and around the world. US operators were compared with outside the United States (OUS) operators and respondent-level comparisons were made with the prior survey to assess for temporal changes in practice. Results Between August 2016 and January 1, 2017, 125 interventional cardiologists completed the survey representing 91 countries with the United States having 449 (39.9%) respondents. Preprocedure, noninvasive testing for collateral circulation is used more commonly in the United States (54.1%) than around the world (26.6%) but its use has decreased since 2010. In the US, 48.8% of operators never use ultrasound and 92.6% of OUS operators never use it; only 4.4% overall use ultrasound in >50% of cases. Use of bivalirudin has decreased in the US and OUS. Nearly, 30% of operators do not assess for radial artery patency following hemostasis. US respondents used TRA less commonly for primary PCI for STEMI than their global counterparts. Conclusions There is wide variation in how TRA procedures are performed including relatively low rates of adherence to practices that are known to improve outcomes. Further education aimed at increasing use of best practices will impact patient outcomes.

AIMS To assess the benefit of routine preprocedural radial artery (RA) angiography in patients with ST segment elevation myocardial infarction (STEMI). METHODS AND RESULTS All consecutive STEMI patients, in the period from January 2010 until December 2016 were included in the study. Preprocedural radial artery angiography was performed in all patients since March 2011. We compared clinical and procedure characteristics, access site bleeding complications and failure of primary chosen TRA between two groups of STEMI patients before and after we started performing routine RA angiography. We compared 762 STEMI patients from 2010 until March 2011 and 4306 STEMI patients after March 2011 until December 2016. Mean age of patients was 60 ± 11 years with 73% males. The latter group had more elderly and obese patients (P

Objective To compare radiation exposure during transradial diagnostic coronary angiography (DCA) using standard single- or multi-catheters with different shapes. Background Transradial DCA can be performed using single- or multi-catheters to canulate left and right coronary ostia. To date, it remains unknown whether there are differences in radiation exposure between the two strategies. Methods From November 2012 to June 2014, 3,410 consecutive patients who underwent transradial DCA were recruited. Groups were based on the initial diagnostic catheter used and were dichotomized between single- and multi-catheters approach. All crossovers were excluded. The multi-catheters approach (Multi) group consisted of Judkins left and right catheters, whereas the single-catheter (Single) group included Amplatz, Barbeau, or Multipurpose catheters. Fluoroscopy time (FT) as a surrogate end-point for total radiation exposure and kerma-area product (KAP; patient radiation exposure) were collected as radiation exposure parameters. Results A single-catheter strategy was used in 439 patients, while 2,971 patients had a multi-catheters approach. There was no significant difference in FT between groups (2.86 ± 1.48 min for Multi vs. 2.87 ± 1.72 min for Single, P = 0.13). The multi-catheters approach was associated with a significant 15% reduction in KAP (3,599 ± 2,214 cGy · cm2 vs. 3,073 ± 1,785 cGy · cm2, P

Objectives To evaluate the feasibility and potential benefits of performing sheathless 5Fr transradial percutaneous coronary interventions (PCI) using 4Fr diagnostic catheters as dilators. Background There is a direct association between artery–catheter mismatch and risk of radial artery occlusion. Methods We recruited 130 patients who underwent 4Fr sheathless diagnostic angiography with super torque (Cordis Corporation, USA) catheters followed by ad hoc PCI. To facilitate skin and vessel penetration, the Judkins right catheter (110 cm) was inserted inside the 5Fr guiding catheter (100 cm) as dilator. Results The mean age of patients was 63 ± 12 years with 74% of males. Unfractionated heparin monotherapy was used in 84%, bivalirudin in 12%, and platelet glycoprotein 2b/3a inhibitors in 13%. Right radial artery was used in 99%. In three cases, no PCI was performed (FFR) and in two (1.5%) cases, a sheath was required after guiding catheter insertion due to local bleeding. In six cases (4.6%), upscale to 6Fr sheathed approach was required. No spasm occurred. Overall procedural success was achieved in 114/119 (96%) cases, including left main PCI, bifurcation PCI in 10 (8%) cases, CTO in 5 (4%) and IVUS use in 6 (5%) cases. Immediately after hemostasis completion, duplex ultrasound showed normal flow in 76%, occlusive thrombus in 13%, pseudo-aneurysmal dilatation in 11% and local hematoma surrounding puncture site in 20%. Hemoglobin dropped from 138 ± 19 g/l to 131 ± 16 g/l 4–6 hours after PCI. Conclusion Using 4Fr diagnostic catheters as dilators, simple and complex PCI can be performed with standard 5Fr guiding catheters as sheathless techniques. However, suboptimal transition between diagnostic and guiding catheters likely creates radial artery trauma leading to frequent occlusive thrombus and hematoma surrounding the radial artery. © 2014 Wiley Periodicals, Inc.

Objective To examine the use and outcomes of balloon-assisted tracking (BAT) technique for dealing with complexities of arm and chest vasculature during transradial approach (TRA) at a single high volume radial center. Background TRA has been used for coronary angiography and percutaneous coronary interventions (PCI) around the world. Different techniques have been described to address the anatomical issues and tortuosities for successful completion of coronary angiography and PCI. This study describes the use of BAT technique and associated outcomes during real world clinical practice. Methods Subjects comprised 63 patients, (out of total 8,245 patients between January 2011 and December 2012) in whom we encountered significantly complex anatomical course in radial, brachial, or subclavian region, leading to difficult advancement of a diagnostic or a guide catheter despite trying all standard maneuvers. In all of them BAT technique was used and they were retrospectively analyzed for the purpose of this study. Results About 63 (0.76%) of 8,245 patients met the study criteria. Twenty-five (39.7%) patients had very small RA. Twenty-two (34.9%) had severe RA tortuosity. Four (6.3%) had complex RA loops. Six (9.5%) had severe RA spasm and six (9.5%) had severe subclavian tortuosity and/or stenosis. We encountered technical failure in three (4.8%) patients (two had very small RA and one had 360 degree RA loop). Conclusion BAT technique was useful to address the anatomical issues and tortuosities of radial, brachial, and subclavian vasculature during TRA. © 2013 Wiley Periodicals, Inc.

Objectives To determine the prevalence of a concurrent CTO in men and women and to examine its impact on mortality. Background The impact of chronic total occlusion (CTO) in patients with ST-elevation myocardial infarction (STEMI) according to gender has not been assessed. Methods Patients referred with STEMI were categorized into single vessel disease (SVD), multivessel disease (MVD) without, with 1 or > 1 CTO. The primary end-point was the 1-year mortality. Results Among the 2020 STEMI patients included between 2006 and 2011, 24% were female. Women were older, had more hypertension and renal failure (P 1 concurrent CTO was similar in both sexes, 7 and 1%, respectively. Early and late mortality was significantly higher in women compared with men (P 1 CTO (100%) and with 1 CTO (36.4%) compared with those with MVD without CTO (18.4%) or with SVD (10.4%) (P < 0.0001). MVD with and without concurrent CTO were both independent predictors of 1-year mortality in women (HR 3.58; 95 % CI 1.69–7.18 and HR 2.76; 95 % CI 1.33–5.51) whereas only MVD with CTO was predictive in men (HR 2.19; 95% CI 1.20–3.97). Conclusions Among unselected STEMI patients, the prevalence of CTO was equal in both sexes whereas early and late mortality remained significantly higher in women. Other factors than the presence of a concurrent CTO must be explored to explain differences in survival after STEMI between women and men. © 2013 Wiley Periodicals, Inc.

In response to growing U.S. interest, the Society for Coronary Angiography and Interventions recently formed a Transradial Committee whose purpose is to examine the utility, utilization, and training considerations related to transradial access for percutaneous coronary and peripheral procedures. With international partnership, the committee has composed a comprehensive overview of this subject presented here-with.

Background: The use of routine aspiration thrombectomy in primary percutaneous coronary intervention (PCI) remains controversial. Methods: Patients in the EArly Discharge after Transradial Stenting of CoronarY Arteries in Acute Myocardial Infarction (n = 105) study were treated with aspirin, clopidogrel, and abciximab within 6 hr of symptoms onset. Operators were allowed to use 6 Fr Export aspiration catheter at their discretion. In this observational analysis, we compared acute and late results in patients treated with and without thrombectomy using cardiac biomarkers, angiographic, cardiovascular magnetic resonance (CMR), and clinical parameters. Results. Patients in the thrombectomy group (n = 44) had longer symptoms to balloon time (196 ± 86 min vs. 164 ± 62, P = 0.039) and higher incidence of preprocedural TIMI flow grade 0 or 1 (84% vs. 64%, P = 0.028). Following PCI, both groups had similar incidence of TIMI flow grade 3 (93 vs. 92%, P = 0.73) and myocardial blush grade 2 or 3 (80 vs. 77%, P = 0.86), respectively. Patients in thrombectomy group had significantly higher post-PCI maximum values of creatine kinase-MB (P = 0.0007) and troponin T (P = 0.0010). Accordingly, post-PCI myocardial necrosis by CMR was higher (P = 0.0030) in patients in the thrombectomy group. At 6-month follow-up, necrosis size remained higher (20.7% ± 13.3% vs. 13.5% ± 11.1%, P = 0.012) in the thrombectomy group. Ejection fraction at 6 months was 65% ± 9% in patients in thrombectomy group compared to 70% ± 11% in patients without (P = 0.070). Results were not affected by initial TIMI flow or symptoms to balloon time. Clinical events remained comparable in both groups at 12 months follow-up. Conclusion: In patients with ST-segment elevation myocardial infarction presenting within 6 hr of symptoms and undergoing primary angioplasty with maximal antiplatelet therapy, acute and late results did not suggest significant benefit for additional aspiration thrombectomy, irrespective of initial TIMI flow or total ischemic time. © 2010 Wiley-Liss, Inc.

BACKGROUND: Anticoagulant therapy is required to prevent radial artery occlusion (RAO) after transradial catheterization. There is no data comparing bivalirudin to standard heparin. METHODS: We studied 400 consecutive patients. In case of diagnostic angiography-only (n = 200), they received an intravenous bolus of heparin (70 U kg(-1)) immediately before sheath removal whereas in case of angiography followed by ad hoc percutaneous coronary intervention (n = 200), they received bivalirudin (bolus 0.75 mg kg(-1), followed by infusion at 1.75 mg/kg/h). RAO was assessed 4-8 weeks later using two-dimensional echography-doppler and reverse Allen's test with pulse oximetry. RESULTS: At follow-up, 21 of the 400 (5.3%) patients were found to have RAO with no significant difference between the two groups (3.5% bivalirudin vs. 7.0% heparin, P = 0.18). Patients with RAO had a significantly lower weight compared to patients without RAO (78 ± 13 kg vs. 86 ± 18 kg, P = 0.011). By multivariate analysis, a weight

Background: No data are available on the long term efficacy of abciximab bolus-only with aspirin and clopidogrel pretreatment and systematic coronary stenting. Our objective was to evaluate the 3-year clinical outcomes in the EASY trial. Methods: After a bolus of abciximab (0.25 mg/kg) and uncomplicated transradial coronary stenting, 1,005 patients were randomized either to same-day home discharge and no infusion (bolus-only group, n = 504) or to overnight hospitalization and 12 hours abciximab infusion (bolus + infusion group, n = 501). In contrast, 343 patients were not randomized after stenting for safety reasons and received abciximab bolus and infusion (not-randomized group). The rate of major adverse cardiovascular events (MACE), including death, myocardial infarction (MI) and target vessel revascularization (TVR) after percutaneous coronary intervention (PCI) was evaluated. Results: Up to 3 years, the incidence of MACE remained similar in the two randomized groups, 14% in bolus-only vs. 17% in bolus + infusion (P = 0.38). Similar efficacy was observed in subgroups analysis including higher-risk patients such as those with diabetes, unstable angina or non-ST elevation MI. Conversely, the incidence of MACE remained significantly higher in patients not-randomized post-PCI at all time intervals (P < 0.0001). The difference in outcomes between randomized and not-randomized patients was mostly accounted by the higher rates of MI, TVR as survival rate remained similar. Conclusion: In patients pretreated with aspirin and clopidogrel and undergoing uncomplicated coronary artery stenting, abciximab bolus-only was associated with similar outcomes compared with bolus followed by infusion, up to 3 years after PCI. Conversely, patients with suboptimal results or clinical complications during PCI remained at higher risk of late revascularization or MI. © 2009 Wiley-Liss, Inc.

Background: To develop a safe practice of same-day discharge after percutaneous coronary intervention (PCI), it is important to identify early the patients who need to remain hospitalized and potentially require more careful follow-up. In the EASY trial, a large number of patients with acute coronary syndromes were enrolled prior to PCI to be randomized between same-day discharge or overnight hospitalization. Based on a few angiographic criteria, suboptimal results, or clinical complications, some patients were excluded from randomization after PCI. Objectives: We report the early and late outcomes of those patients, and evaluate the use of simple criteria precluding same-day discharge. Results: The rate of major adverse cardiac events including death, myocardial infarction, and target vessel revascularization in patients excluded from randomization (n = 343) was significantly higher at 30 days (10.2% vs. 1.6%), 6 months (17.5% vs. 5.6%), and 12 months (24.5% vs. 9%) compared with randomized patients (n = 1,005; P < 0.0001). At 12 months, only transient vessel closure (HR 1.78, 95% CI 1.10–2.65, P = 0.023) and a residual dissection ≥ grade B post-PCI (HR 1.53, 95% CI 1.11–2.05, P = 0.011) were independent predictive factors of adverse outcomes. Conclusion: Criteria associated with angiographic suboptimal results or clinical complications are useful to identify patients ineligible for same-day discharge after PCI, regardless of the clinical presentation. Patients excluded from same-day discharge after PCI for safety concerns have worse early and late outcomes. Transient vessel closure and persisting moderate dissection after PCI remain independent predictors of late adverse outcomes after PCI with maximal antiplatelet therapy. © 2008 Wiley-Liss, Inc.

Objectives: (1) To evaluate the clinical outcomes of patients with moderate coronary lesions and borderline fractional flow reserve (FFR) measurements (between 0.75 and 0.80), comparing those who underwent coronary revascularization (CR) to those who had medical treatment (MT), and (2) to determine the predictive factors of major adverse cardiac events (MACE) at follow-up. Methods: A total of 107 consecutive patients (mean age 62 ± 10 years) with at least one moderate coronary lesion (mean percent diameter stenosis 47 ± 12%) evaluated by coronary pressure wire with FFR measurement between 0.75 and 0.80 (mean 0.77 ± 0.02) were included in the study. MACE [CR, myocardial infarction (MI), cardiac death) and the presence of angina were evaluated at follow-up. Results: Sixty-three patients (59%) underwent CR and 44 patients (41%) had MT, with no clinical differences between groups. At a mean follow-up of 13 ± 7 months, MACE related to the coronary lesion evaluated by FFR were higher in the MT group compared with CR group (23% vs. 5%, P = 0.005). Most MACE consisted of CRs, with no differences between groups in MI and cardiac death rate at follow-up. Both MT and FFR measurements in an artery supplying a territory with previous MI were independent predictive factors of MACE at follow-up, respectively (hazard ratio 5.2, 95% CI 1.4–18.9, P = 0.01; hazard ratio 4.1, 95% CI 1.1–15.3, P = 0.03). The presence of angina at follow-up was more frequent in the MT group compared with the CR group (41% vs. 9%, P = 0.002). Conclusions: In patients with moderate coronary lesions and borderline FFR measurements deferral of revascularization was associated with a higher rate of MACE (CR) and a higher prevalence of angina at follow-up, especially in those with previous MI in the territory evaluated by FFR. Further prospective randomized studies should confirm whether or not an FFR cut-off point of 0.80 instead of 0.75 would be more appropriate for deferring CR in these cases. © 2008 Wiley-Liss, Inc.

Background: Several contrast media (CM) are used for diagnostic angiography and coronary percutaneous interventions. Catheter miniaturization allows performance of most diagnostic studies using 4–5 F catheters and interventions using 5–6 F catheters. As a result of catheter lumen downsizing and viscosity of CM, the operators are sometimes required to forcefully inject to produce adequate images. Methods and Results: The aim of the study is to perform a comparative rheology analysis between three different commonly used CM: iso-osmolar, nonionic iodixanol, Visipaque®, (GE Healthcare); low-osmolar, nonionic ioversol, Optiray®; and low-osmolar, ionic ioxaglate, Hexabrix®, (Tyco Healthcare, US). The viscosity was experimentally assessed for temperature varying from 14 to 40°C. To reproduce clinical use, an experimental set-up was used and the pressure developed to inject CM was evaluated at different temperatures and compared between the three CM. All three agents demonstrated a nonlinear inverse relationship between temperature and viscosity. At 14°C iodixanol showed a twofold increase in viscosity compared with ioversol and ioxaglate. At 40°C, the difference was reduced to 27%. At room temperature (20°C), the difference in pressure needed to inject CM was 10% between iodixanol and ioxaglate and 6% between iodixanol and ioversol. As the temperatures increased, the differences in pressure became less important, becoming negligible (1%) at 37°C. Conclusion: The viscosity of the iso-osmolar nonionic contrast agent iodixanol showed a stronger dependence on temperature compared with ioversol and ioxaglate. The impact of differences in viscosity and pressure to inject between CM were minimized at 37°C. This emphasizes the importance of temperature control when using current low-osmolar CM and iso-osmolar CM with smaller sized catheters. © 2008 Wiley-Liss, Inc.

We report our initial experience in 10 consecutive patients who underwent transradial coronary brachytherapy for in-stent restenosis using a 90Sr/Y source and the Novoste Beta-Rail system. In all patients, procedures were successfully completed using a right transradial approach. We performed the procedures with the Beta-Rail catheter using 7 Fr (Zuma II, Medtronic, MN; n = 5) or 8 Fr (Cordis, Miami, FL; n = 5) guiding catheters. All lesions were successfully dilated and no additional stent was inserted. We used a 40 mm source (n = 3) or a 60 mm source (n = 7) with manual stepping in four cases. In three cases, we did one stepping, and in one case, we did three steppings. The mean dwell time was 195 plus minus 44 sec. The mean delivered dose was 23 +/- 3 Gy at 2 mm distance from the source. No radiation treatment was interrupted. Mean fluoroscopy time was 26 +/- 13 min. Procedural success was achieved in all patients. Three patients had mild CK elevations (< 3 times upper normal limit). All patients were pretreated with clopidogrel (300 mg) and combined treatment with aspirin + clopidogrel is to be continued for at least 1 year. Clinical follow-up up to 3 months has not yielded any complication and all patients have remained free from angina.

Since late myocardial infarctions after percutaneous coronary interventions have not been well characterized, we intended to evaluate the characteristics of myocardial infarctions occurring > 48 hr after balloon angioplasty of native coronary arteries or saphenous vein grafts. The Montreal Heart Institute database (1985-1996) was interrogated for all patients readmitted with a diagnosis of MI more than 48 hr after successful percutaneous transluminal coronary angioplasty (PTCA). We compared the clinical, procedural, and angiographic variables between MIs related or not to the index PTCA site. One hundred and ninety-three patients presented with late myocardial infarction (MI) following balloon angioplasty. The median time elapsed between PTCA and MI was 55 days compared to 968 days when MI was unrelated to the PTCA site. MIs related to the PTCA site were more likely non-Q-wave (76% vs. 35%, P = 0.0001) with less marked CK-MB rise. Angiography showed less complex lesions (63% vs. 90%, P = 0.001) and better thrombolysis in myocardial infarction (TIMI) grade flow (TIMI II to III, 66% vs. 56%, P = 0.01) when the culprit lesion was at the PTCA site. Independent predictors of MI at the PTCA site were vein graft dilation, female sex, and residual stenosis post-PTCA. Myocardial infarctions occurring late after PTCA have a distinct time course and present specific characteristics according to their relationship or not to the previously dilated site.