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Biomedical subjects

G S Roubin

Publications and source records attributed to G S Roubin.

At least 91 records · Page 5Linked to original sources

'Bail out' stenting: case closed.

Since the first description of percutaneous transluminal coronary angioplasty (PTCA), the number of patients who have undergone this procedure has rapidly increased. Two problems have plagued PTCA: acute vessel closure and restenosis. Acute vessel closure following PTCA increases the incidence of in-hospital death, myocardial infarction and coronary bypass grafting. The advent of intracoronary stenting for acute closure has had a profound impact on these complications. Complications following intracoronary stenting have declined with modification of anticoagulation post-stenting and an improved understanding of stent mechanics. Further refinement of these devices and continued improvement in our understanding of them should lead to further reduction of post-stent complications and improved patient outcomes.

Acute Disease↗

Length of hospital stay and complications after percutaneous transluminal coronary angioplasty. Clinical and procedural predictors. Heparin Registry Investigators.

BACKGROUND: Although several studies have established that the complications of percutaneous transluminal coronary angioplasty (PTCA) are related to clinical and angiographic variables such as advanced age and lesion complexity, it is uncertain whether the use of hospital resources after PTCA also depends on the same baseline variables. The purpose of this study was to identify the factors responsible for prolonged hospital stay after PTCA. METHODS AND RESULTS: The study cohort included 591 consecutive patients undergoing conventional balloon angioplasty at nine medical centers in North America. Major or minor complications occurred in 91 patients (15.4%) and were observed to be related to several baseline characteristics, including unstable angina, multivessel coronary artery disease, patient age, and lesion complexity. Compared with a median length of hospital stay of 2.0 days after PTCA (25th, 75th percentiles: 2.0, 4.0) for the entire cohort of patients, the length of stay was increased in patients with unstable angina (3.0 days [2.0, 5.0]; P = .002), multivessel coronary artery disease (3.0 [2.0, 5.5]; P = .001), age > 65 years (3.0 [2.0, 5.5]; P = .02), complex lesions (3.0 [2.0, 6.0]; P = .001), and filling defects (6.0 [2.0, 11.0]; P < .001). The length of stay was more strikingly increased, however, in patients who experienced major or minor PTCA complications, such as emergency bypass surgery (9.0 days [8.0, 18.0]; P < .001), Q-wave or non-Q-wave myocardial infarction (8.0 [6.0, 15.5]; P < .001), transfusion unrelated to bypass surgery (8.0 [4.0, 12.0]; P < .001), or abrupt vessel closure (6.0 [3.0, 10.5]; P < .001). On stepwise multiple linear regression, PTCA complications appeared to be the strongest predictors of length of hospital stay (all P < .001) and overwhelmed the weaker relation between length of stay and several individual baseline variables. Inclusion of a composite clinical risk score (reflecting the presence of unstable angina, multivessel disease, advanced age, complex lesions, or filling defects) in the regression model confirmed that patients with several high-risk baseline variables had a significant increase in length of stay after PTCA (P = .003), but PTCA complications remained the strongest predictors of length of stay. CONCLUSIONS: Although PTCA complications were correlated with baseline variables such as unstable angina, multivessel disease, advanced age, complex lesions, and filling defects, excess length of stay after PTCA was most strongly influenced by the development of minor and major PTCA complications. Because patients with several baseline risk factors experienced significantly prolonged hospitalizations, improved selection of patients may contribute to reductions in length of stay after PTCA. A greater reduction in resource use after PTCA, however, would be expected from developing new treatments to decrease PTCA complications rather than limiting the access of patients with unstable angina, advanced age, or complex lesions to PTCA.

Aged↗

Bypass Angioplasty Revascularization Investigation: patient screening, selection, and recruitment.

Percutaneous transluminal coronary angioplasty (PTCA) is currently performed in many patients seeking care because of severe manifestations of multivessel coronary artery disease. Previously, the majority of such patients would have undergone coronary artery bypass grafting (CABG). No definitive evidence is available as to which initial revascularization strategy has the best long-term clinical and economic outcomes. The Bypass Angioplasty Revascularization Investigation (BARI) is the largest of several recent clinical trials that were designed to test the hypothesis that an initial strategy of PTCA in selected patients with multivessel coronary artery disease does not compromise long-term clinical outcome compared with an initial strategy of CABG. This report describes how patients were screened, selected, and recruited in BARI and how this process may influence the results and the interpretation of the trial. During the enrollment period, 25,200 patients undergoing diagnostic coronary angiography at the participating institutions or with off-site angiograms referred to BARI investigators were screened for BARI eligibility. Excluded from screening were patients without coronary artery disease, those with single-vessel disease, prior revascularization, primary congenital, valvular, or myocardial disease, and age > 80 years. Slightly more than half of the patients screened (12,670) were not clinically eligible for BARI because of left main disease, insufficient symptoms, emergency revascularization, or other logistic reasons. Thus, 12,530 patients had severe angina and/or ischemia and were clinically eligible for BARI. Nearly 33% of them (4,110) had multivessel disease, which was suitable for both PTCA and CABG.(ABSTRACT TRUNCATED AT 250 WORDS)

Angioplasty, Balloon, Coronary↗

Coronary stenting decreases restenosis in lesions with early loss in luminal diameter 24 hours after successful PTCA.

BACKGROUND: Early loss of minimal luminal diameter (MLD) after successful percutaneous transluminal coronary angioplasty (PTCA) is associated with a higher incidence of late restenosis. METHODS AND RESULTS: Sixty-six patients (66 lesions) with > 0.3 mm MLD loss at 24-hour on-line quantitative coronary angiography were randomized into two groups: 1, Gianturco-Roubin stent (n = 33) and 2, Control, who received medical therapy only (n = 33). All lesions were suitable for stenting. Baseline demographic, clinical, and angiographic characteristics were similar in the two groups. Restenosis (> or = 50% stenosis) for the overall group occurred in 32 of 66 patients (48.4%) at 3.6 +/- 1-month follow-up angiography. Restenosis was significantly greater in group 2 than in group 1 (75.7% versus 21.2%, P < .001). Vascular complications (21.2% versus 0%) and length of hospital stay (7.3 +/- 1 versus 2.4 +/- 0.5 days, P < .01) were higher for the stent group. Although at follow-up there were no differences in mortality or incidence of acute myocardial infarction between the two groups, patients in the control group had a higher incidence of repeat revascularization procedures (73% versus 21%, P < .001). CONCLUSIONS: In patients with successful PTCA but reduced luminal diameter demonstrated by repeat angiography at 24 hours, the Gianturco-Roubin stent appears to reduce angiographic restenosis at follow-up.

Angioplasty, Balloon, Coronary↗

Stratification of the risk of thrombosis after intracoronary stenting for threatened or acute closure complicating coronary balloon angioplasty: a Cook registry study.

This study was carried out to stratify the risk of stent thrombosis by using three predictors: stent size, poststenting residual dissection, and residual filling defect. In the multicenter clinical trial, 1318 patients had successful deployment of Gianturco-Roubin coronary stent for threatened and acute closure. The 714 (54.2%) patients having none of these risk factors were designated a low-risk group; 484 (36.6%) had one factor and were designated an intermediate-risk group; 120 (9.1%) had two or all three factors and were designated a high-risk group. The incidence of stent thrombosis was 5.6%, 9.4%, and 16.7% in the low-, intermediate-, and high-risk groups; the difference among the three groups was highly significant (p < 0.0001). With these three predictors, the risk of stent thrombosis can be stratified. Avoiding the use of small stents (< 3.0 mm) and achieving optimal angiographic results after stenting for acute or threatened closure are useful strategies in reducing stent thrombosis.

Acute Disease↗

Acute angiographic and clinical results of long balloon percutaneous transluminal coronary angioplasty and adjuvant stenting for long narrowings.

Historically, long coronary artery stenoses undergoing percutaneous transluminal coronary angioplasty (PTCA) are reported to have reduced procedural and clinical success in comparison with shorter lesions. The efficacy of long balloons (30 or 40 mm) in long lesions was evaluated. Eighty-two patients had 84 PTCA procedures with a primary long balloon. In all, 86 lesions were available for analysis. Data were collected prospectively on standard PTCA procedure forms. Coronary angiograms were reviewed and measured with digital calipers. Hospital charts were examined for complications. PTCA was performed in the left anterior descending artery in 44 cases (51%), the right coronary artery in 29 (34%) and the circumflex artery in 13 (15%). With the use of a modified classification system, 47 lesions (55%) were class C, 24 (28%) were class B2 and 15 (17%) were class B1. Mean lesion length was 22 +/- 11 mm (range 10 to 72), and 38 lesions (44%) were > or = 20 mm. Twelve patients received an intracoronary stent. The long balloon alone produced angiographic success (< 50% residual stenosis) in 77 lesions (90%). Angiographic success was achieved ultimately in all stenoses, using a stent in 7 patients and a short balloon in 2. There were 2 deaths (2%) and 1 Q-wave myocardial infarction (1%). One patient needed coronary artery bypass surgery. Clinical success without death, Q-wave infarction or bypass surgery was achieved in 83 of 86 procedures (97%). In conclusion, the use of long PTCA balloons with adjuvant stenting produced excellent results in these long stenoses. Lesion length was not a precursor of poor angiographic or clinical outcome.

Adult↗

Balloon angioplasty for treatment of in-stent restenosis: feasibility, safety, and efficacy.

Sixty patients with 1 or 2 stainless steel intracoronary stents (Cook, Inc.) underwent balloon angioplasty for in-stent restenosis 1.5-13.5 months after stenting. Seventy-five in-stent redilatation procedures were performed. Seventy-three restenotic lesions (97%) were successfully recrossed and dilated, reducing the mean pre-angioplasty intrastent diameter stenosis from 77 +/- 12% to 20 +/- 11% residual. Although one angioplasty (1.3%) was complicated by non-Q-wave infarction, no angioplasty-related death, acute closure, need for additional stenting, emergent coronary bypass surgery, side branch occlusion, or vascular sequelae occurred. Post-procedure heparin was not used in 83% of successful cases. Most patients were discharged the day following redilatation (mean in-hospital stay 1.7 +/- 1.3 days). At 5.4 +/- 3.4 months following in-stent angioplasty, 84% of patients were in Canadian Cardiovascular Society class 0 or I. In conclusion, balloon dilatation in this stent for restenosis appears simple and efficacious in the short term, and may entail less risk than dilatation of unprotected coronary vessels.

Adult↗

Sizing the Gianturco-Roubin coronary flexible coil stent.

The balloon expandable, stainless steel, flexible coil stent is a useful device for the management of acute or threatened closure after percutaneous transluminal coronary angioplasty. Appropriate sizing is important to optimize immediate results and reduce the risk of acute thrombosis and restenosis. The in vivo size at deployment of this stent at nominal inflation pressures has not been evaluated. Forty patients who received a single flexible coil stent (10 patients each for stent sizes 4.0, 3.5, 3.0, and 2.5 mm) were studied. The stents were deployed at 3-5 atmospheres. The actual stent size achieved by the stent during deployment was found to be significantly less than the nominal size, being 3.7 +/- 0.3, 3.2 +/- 0.2, and 2.8 +/- 0.2 mm for nominal stent sizes of 4.0, 3.5, and 3.0 mm, respectively (P < 0.005, P < 0.001, and P < 0.01). For a 2.5 mm stent, it was 2.4 +/- 0.2 mm (P = ns). Thus, for optimal results with this device, we recommend that vessels 2.0-2.4 mm in diameter be supported by a 2.5 mm stent, vessels 2.5-2.9 mm in diameter by a 3.0 mm stent, vessels 3.0-3.4 mm in diameter by a 3.5 mm stent, and vessels 3.5-4.0 mm in diameter by a 4.0 mm stent.

Adult↗

Effect of angiographic and hemodynamic results of coronary balloon angioplasty on late angiographic outcome.

A small residual stenosis and a low residual translesional pressure gradient after percutaneous transluminal coronary angioplasty (PTCA) are thought to be associated with lower rates of restenosis. However, these two posprocedure parameters have not been studied simultaneously in relation to late angiographic outcome. Restudy angiograms after successful single-vessel and single-lesion PTCA were performed in 1261 patients, who were divided into three groups according to final residual stenosis: group 1, 0% to 19%, group 2, 20% to 34%, and group 3, 35% to 49%. This study population also was divided into two groups by final residual pressure gradient: < or = 17 and > or = 18 mm Hg. Luminal patency at restudy and restenosis rates by these definitions were studied. By the definition of > or = 50% stenosis at restudy, group 1 had the lowest restenosis rate, and group 3 had the highest. By the definition of an increase of > or = 30% stenosis compared with the immediate post-PTCA result, group 1 had the highest restenosis rate, and group 3 had the lowest. Although it had the greatest loss of luminal diameter over the follow-up period, group 1 maintained the greatest luminal patency at restudy. A residual pressure gradient < or = 17 mm Hg was associated with lower restenosis rate regardless of the definition used. Despite greater loss of luminal diameter over the follow-up period, optimal postprocedure angiographic results may result in better long-term luminal patency. Transluminal pressure gradient is more predictive of late angiographic results regardless of the definition used. Further studies, with hemodynamic measurements, may reveal potential clinical implications.

Analysis of Variance↗

Evaluating new devices. Acute (in-hospital) results from the New Approaches to Coronary Intervention Registry.

BACKGROUND: To be used optimally, new interventional devices (stent, lasers, atherectomy catheters) must be carefully evaluated in terms of optimal patient and lesion selection, technique of use, expected acute success and complications, and long-term results. Sources for that information include single-center and multicenter (single-device) reports, although randomized trials may then be performed to provide a more definitive picture of any clinical benefits. One interim option, however, consists of carefully collected registry data. The purpose of this article is to review data collected in the National Heart, Lung, and Blood Institute-funded New Approaches to Coronary Intervention (NACI) Registry and to compare them with existing reports. METHODS AND RESULTS: NACI is an independent, investigator-driven effort that seeks to collect uniform data on patients undergoing treatment with one of several investigational devices and thereby provide an unbiased report of procedure outcome. Between November 1990 and November 1992, 36 participating centers treated a total of 3201 lesions in 2835 patients, using one of seven study devices: directional atherectomy (1084 lesions), transluminal extraction atherectomy (240 lesions), rotational atherectomy (349 lesions), Palmaz-Schatz stent (674 lesions), Gianturco-Roubin stent (213 lesions), and the Advanced Interventional Systems (474 lesions) or Spectranetics (167 lesions) excimer lasers. Data on each procedure were recorded on a unique modular database that captured the reason for (and interim result after) each device use. Device success (defined here as stenosis improvement by > or = 20% and a residual stenosis < 50% after new device use) was 66.5% overall. Adjunctive angioplasty was used in 75.5% of lesions, either before (25.9%) or after (43.5%) new device use, yielding an overall lesion success (> or = 20% stenosis improvement with a final residual stenosis < 50% after all devices) of 92.2%. Adjunctive angioplasty after new device use produced further enlargement in minimal lumen diameter (from 2.2 to 2.7 mm) and further reduction in residual stenosis (26.4% to 16.1%) compared with the results present after use of the new devices themselves. Major complications consisting of death (1.6%), Q-wave myocardial infarction (1.3%), or emergency bypass surgery (1.7%) occurred in 4.0% of patients (range, 2.6% to 8.7% across devices). Procedural success, defined as lesion success in all new device-treated lesions without a major complication, was achieved in 90.8% of patients, with a median length of hospital stay of 4 days. CONCLUSIONS: NACI illustrates the type of information that can be obtained in a registry format that examines the acute angiographic and clinical results of new devices according to uniform definitions. Although no registry can substitute for formal interdevice trials, registries such as this can supplement earlier single-center and multicenter reports. In doing so, they can help focus subsequent randomized interdevice comparisons on lesion types for which two or more devices have promising acute results. Given the substantial interdevice differences in baseline patient and lesion characteristics found in NACI, simple "head-to-head" comparison of the results of different devices might give misleading impressions and should be avoided unless such comparisons are restricted to carefully matched patient and lesion subgroups.

Angioplasty, Laser↗

Major clinical events after coronary stenting. The multicenter registry of acute and elective Gianturco-Roubin stent placement. The Gianturco-Roubin Intracoronary Stent Investigator Group.

BACKGROUND: Abrupt vessel closure and early reocclusion remain the principal vascular events underlying early recurrent ischemia complicating elective percutaneous transluminal coronary angioplasty (PTCA). Intracoronary stenting has been used to circumvent emergency bypass surgery after acute vessel closure and as an adjunct for the elective treatment of restenosis. The initial multicenter experience with the Gianturco-Roubin stent is presented, and predictors for early recurrent ischemic events are identified. METHODS AND RESULTS: Data accrued from 639 serial patients undergoing emergency stenting for abrupt closure (n = 415; 65%) or elective deployment for restenosis (n = 224; 35%) from October 1989 through May 1991 were analyzed. The incidence of subsequent ischemic events, including death, nonfatal myocardial infarction, and bypass surgery referral within 90 days of the procedure, was higher after acute deployment (20%) compared with elective stenting (9%; P = .0004). Although mortality within the two cohorts was the same (3%; P = NS), there were significant differences in the incidence of nonfatal myocardial infarction (5% versus 0.5%; P = .002) and bypass surgery (12% versus 6%; P = .02) between the acutely and electively stented patients, respectively. These events were significantly more common when the stent was undersized to the target vessel diameter (stent:artery ratio for event, 0.95 +/- 0.14 versus no event, 1.04 +/- 0.22; P = .0001) or when there was less expansion of the lesion by the deployed device (stent-to-lesion diameter ratio for event, 6.6 +/- 9.2 versus no event, 11.0 +/- 21.4; P = .0001). In a stepwise logistic regression model, acute stenting (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.3 to 2.4), multivessel disease (OR, 1.4; CI, 1.1 to 1.8), larger target lesion diameter (OR, 2.1; CI, 1.4 to 3.2), larger target vessel (OR, 2.9; CI, 1.7 to 4.7), and smaller stent size (OR, 6.1; CI, 3.0 to 12.3) were independent predictors of early, recurrent ischemic events. The presence of thrombus was associated with a higher event rate after elective stenting (OR, 2.3; CI, 1.06 to 5.4) but was not associated with a higher early event rate after acute stenting. CONCLUSIONS: Early ischemic events are more common after acute stenting for abrupt or threatened closure than after elective deployment. These events may be avoided with careful attention to morphometric characteristics to avoid undersizing the stent to the target vessel and ensure adequate lesion expansion.

Angioplasty, Balloon, Coronary↗

A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty.

OBJECTIVES: A new percutaneous collagen hemostasis device was compared with conventional compression techniques after diagnostic catheterization and angioplasty. BACKGROUND: Peripheral vascular complications after diagnostic catheterization or more complex interventional procedures, as well as the discomfort of manual compression and prolonged bed rest, represent significant morbidity for invasive cardiac procedures. METHODS: A prospective, multicenter, randomized trial was designed to compare the hemostasis time in minutes and the incidence of vascular complications in patients receiving a vascular hemostasis device with those undergoing conventional compression techniques. RESULTS: After diagnostic catheterization, hemostasis time was significantly less with the vascular hemostasis device than with conventional manual compression (4.1 +/- 2.8 min [n = 90 patients] vs. 17.6 +/- 9.2 min [n = 75], p < 0.0001). This difference was greater in patients undergoing angioplasty and was unrelated to the anticoagulation status (4.3 +/- 3.7 min [n = 71 not receiving heparin], 7.6 +/- 11.6 min [n = 85 receiving heparin], 33.6 +/- 24.2 min [n = 134 control patients not receiving heparin], p < 0.0001 vs. control patients). The time from the start of the procedure to ambulation was slightly less after diagnostic catheterization in patients treated with the device (13.3 +/- 12.1 h vs. 19.2 +/- 17.8 h, p < 0.05). It was also less in patients who underwent angioplasty when the device was used after discontinuation of anticoagulation (23.0 +/- 11.1 h, without heparin), as compared with control compression techniques (32.7 +/- 18.8 h, p < 0.0001). Time to ambulation was even shorter (16.1 +/- 11.1 h, p < 0.0001) in patients in whom the device was placed immediately after angioplasty while they were still fully anticoagulated with a prolonged activated clotting time (336 +/- 85 s). There were no major complications (surgery or transfusion) after diagnostic catheterization and a low incidence of major complications in patients who underwent angioplasty (0.7% in control patients, 1.4% with the device without heparin, 1.2% with the device and heparin, p = NS). After angioplasty, there was a trend toward fewer hematomas when the device was used in the absence of heparin (4.2% vs. 9.7% in control patients, p = 0.14). CONCLUSIONS: A new vascular hemostasis device can significantly reduce the puncture site hemostasis time and the time to ambulation without significantly increasing the risk of peripheral vascular complications. The role of this technology in reducing complications, length of hospital stay and cost remains to be determined.

Aged↗

Collateralized chronic total occlusion: a different animal.

This report describes a patient with a chronically occluded proximal LAD in whom antegrade flow was not re-established by successful dilatation alone. Obliteration of retrograde collateral flow restored antegrade flow. This case demonstrates the potential detrimental effect of vigorous collateral flow on the patency of chronic occlusions after successful PTCA.

Adult↗

Clinically guided closure of femoral arterial pseudoaneurysms complicating cardiac catheterization and coronary angioplasty.

Femoral artery pseudoaneurysm formation is a significant problem in patients undergoing cardiac catheterization and interventional cardiac procedures. It is especially more common with the use of anticoagulant and antiplatelet therapy and the use of intracoronary stents. We describe our initial experience with clinically guided bedside compression of femoral pseudoaneurysms in such patients. Eleven patients, 10 undergoing coronary angioplasty (including 3 with intracoronary stents) and 1 undergoing diagnostic cardiac catheterization, developed a femoral pseudoaneurysm. All patients had a femoral bruit and 9 had an expansile groin hematoma. The diagnosis was confirmed in each case by Doppler ultrasound. Seven patients were receiving heparin while 4 were on oral anticoagulants at the time of detection of the pseudoaneurysm. These patients underwent clinically guided graded external compression to close the pseudoaneurysm neck while maintaining femoral arterial flow. External compression for 104.1 +/- 63 min resulted in successful clinical resolution of pseudoaneurysm in all patients without complications. The results were confirmed by Doppler ultrasound at least 12 hr later. Bedside compression of femoral pseudoaneurysms guided by clinical clues is simple and appears to be an effective and safe technique to manage this iatrogenic problem.

Aged↗

Multicenter investigation of coronary stenting to treat acute or threatened closure after percutaneous transluminal coronary angioplasty: clinical and angiographic outcomes.

OBJECTIVES: This study reports on the initial experience with the Gianturco-Roubin flexible coronary stent. The immediate and 6-month efficacy of the device and the incidence of the complications of death, myocardial infarction, emergency coronary artery bypass surgery and recurrent ischemic events are presented. BACKGROUND: Abrupt or threatened vessel closure after coronary angioplasty is associated with increased risk of myocardial infarction, emergency coronary artery bypass graft surgery and in-hospital death. When dissection or prolapse of dilated plaque into the lumen is unresponsive to additional or prolonged balloon catheter inflation, coronary stenting offers a nonsurgical mechanical means to rapidly restore stable vessel geometry and adequate coronary blood flow. METHODS: From September 1988 through June 1991, 518 patients underwent attempted coronary stenting with the 20-mm long Gianturco-Roubin coronary stent for acute or threatened vessel closure after angioplasty. In 494 patients, one or more stents were deployed. Thirty-two percent of patients received stents for acute closure and 69% for threatened closure. RESULTS: Successful deployment was achieved in 95.4% of patients. Overall, stenting resulted in an immediate angiographic improvement in the diameter stenosis from 63 +/- 25% before stenting to 15 +/- 14% after stenting. Emergency coronary artery bypass graft surgery was required in 4.3% (21 of 493 patients). The incidence of in-hospital myocardial infarction (Q wave and non-Q wave) was 5.5% (27 of 493 patients). At 6 months, myocardial infarction was infrequent, occurring in 1.6% (8 of 493 patients). The incidence of in-hospital death was 2.2% (11 of 493 patients). Late death occurred in 7 patients (1.4%) and 34 patients (6.9%) required later bypass graft surgery. Complications included blood loss, primarily from the arterial access site, and subacute thrombosis of the stented vessel in 43 patients (8.7%). CONCLUSIONS: The early multicenter experience suggests that this stent is a useful adjunct to coronary angioplasty to prevent or minimize complications associated with flow-limiting coronary artery dissections previously correctable only by surgery. Although this study was not randomized, it demonstrated a high technical success rate and encouraging results with respect to the low incidence of emergency coronary artery bypass graft surgery and myocardial infarction.

Adult↗