Safety and feasibility of same-day early discharge after endovascular revascularization of lower extremities in elderly. SENIOR-ER registry.

OBJECTIVE: The aim of the study was to assess safety and feasibility of one-day early discharge (ODD) after endovascular revascularization (ER) of lower extremities in elderly. BACKGROUND: Safety and feasibility of ODD after ER have never been investigated in the elderly, despite the PAD rate has been rising in well-developed countries as their populations are getting older. METHODS: The consecutive data of 477 patients after ER who were intended to ODD were reviewed. The ER procedure (balloon angioplasty, atherectomy, stenting) was performed due to significant, angiographically confirmed arterial stenosis with at least Rutheford III claudication. The population was divided into two groups: ≥70 years old (y. o.) in which were 235 patients and 220 patients <70 y. o., the younger control cohort. The follow-up was performed 24 hr after (24FU) the procedure and 30 days (30FU) after discharge. RESULTS: There were no differences between the groups in the ratio of same-day discharge (99% vs 99.5%, P = 0.6) and the mean time to ambulation was 287.4 ± 43.4 min versus 285.8 ± 45.7 min (P = 0.603). The ODD was not applied in 2 patients ≥70 y. o. due to two pseudoaneurysms requiring surgical repairs and in one from the control group due to retroperitoneal bleeding. There was no MACE or creatinine increase at 24 hr in both groups. At 30 days, there was no incidence of MACE in the ≥70 y. o. group while 3 MACE occurred in the control. The ratio of access site complications was comparable between the groups. CONCLUSION: The study allows for a hypothesis that the advantages of ODD could be safely extended to the patients ≥70 y. o.

Long-Term Outcomes After Percutaneous Lower Extremity Arterial Interventions With Atherectomy vs. Balloon Angioplasty　- Propensity Score-Matched Registry.

BACKGROUND: The impact of endovascular revascularization of the lower extremity arteries with atherectomy (AT) compared with percutaneous transluminal angioplasty (PTA) is still unclear. Therefore, the aim of the study was to compare long-term outcomes after percutaneous PTA and AT in patients requiring endovascular revascularization.Methods and Results:This was a single-center, retrospective registry of obstructive and symptomatic PAD patients who underwent endovascular revascularization. PTA was performed in 215 patients, and AT in 204 (Silver Hawk, EV3, n=125; CSI 360°, n=66; Pathway Medical Technologies, n=13). There were no significant between-group differences in baseline characteristics except for increased CAD, dialysis and CLI prevalence in the PTA group. Following propensity score analysis 131 well-matched pairs were included in analysis. Bail-out stenting was more frequent in the reference group (PTA, 6.1% vs. AT, 0%; P=0.004). At 6- and 12-month follow-up there were no differences in TLR between the groups (PTA, 8.3% vs. AT, 5.3%; P=0.47; and PTA, 16.7% vs. AT, 13.7%; P=0.73, respectively). The difference was in favor of AT at 24-month follow-up (PTA, 29.0% vs. AT, 16.7%; P=0.05). No difference was observed in amputation rate (PTA, 0.7% vs AT, 1.5%; P=0.62). On Kaplan-Meier analysis there were no significant differences between groups in time to TLR, amputation or death. CONCLUSIONS: AT was associated with lower risk of TLR, and this should be confirmed in randomized controlled trials.

Iatrogenic occlusion of bilateral jugular veins, subclavian vein, and superior vena cava after repeated jugular cannulation associated with Arnold-Chiari malformation: Successful endovascular treatment.

An Arnold-Chiari malformation is a congenital central nervous system defect. Raised intracranial pressure is commonly observed, and posterior decompression neurosurgery is the treatment of choice. We describe a patient with iatrogenic occlusion of bilateral jugular veins, subclavian vein, and superior vena cava resulting from repeated central venous cannulations. Because of venous hypertension, the patient suffered from neurologic symptoms: headaches, vision disturbances, and marked head edema. Two stents were used to recanalize the right internal jugular vein and superior vena cava. Symptoms subsided, and the patient returned to work. During 24-month follow-up, stents were patent. The patient remains symptom free and continues working.

Five-year outcomes after revascularization of superficial femoral artery occlusion using Ocelot catheter.

INTRODUCTION: The population of patients with lower limb atherosclerosis includes a considerable proportion of individuals with long superficial femoral artery (SFA) lesions. Chronic total occlusions (CTOs) represent the "last frontier" of percutaneous interventions. While open strategies are considered earlier as standard management for these lesions, the results of a number of trials indicate that endovascular management might become an effective alternative to surgery. MATERIAL AND METHODS: This paper presents 5-year outcomes of a first-in-man (FIM) study (before CE mark) and the registry of OCT Guided Ocelot Catheter (Avinger) for chronic total occlusions of the superficial femoral artery. The study group comprised 10 patients with Rutherford 3 lower limb ischemia including nine men and one woman. RESULTS: The efficacy of the primary intervention was 90%. Angiography performed at 6 months of the procedure, according to the study protocol, revealed 3 and 1 cases of restenosis and reocclusion, respectively, repaired using PTA and open common and deep femoral artery patch plasty. Doppler ultrasound performed at 1, 2 and 5 years after the primary intervention did not reveal significant target vessel restenosis. The primary and primary-assisted patency was 89%. During a 5-year follow-up, four peripheral percutaneous interventions and one femoropopliteal bypass surgery were performed in non-target limbs. There were no cardiovascular deaths, myocardial infarction or stroke and no amputation was required. CONCLUSIONS: This is a first-in-man study reporting long-term follow-up after SFA CTO revascularization using the Ocelot catheter. The catheter proved to have a satisfactory safety profile and a high proportion of CTO crossings. A 5-year follow-up revealed high primary and primary-assisted patency rates.

Percutaneous coronary intervention versus coronary bypass graft surgery for diabetic patients with unstable angina and risk factors for adverse outcomes with bypass: outcome of diabetic patients in the AWESOME randomized trial and registry.

OBJECTIVES: This study compared survival after percutaneous coronary intervention (PCI) with survival after coronary artery bypass graft surgery (CABG) among diabetics in the Veterans Affairs AWESOME (Angina With Extremely Serious Operative Mortality Evaluation) study randomized trial and registry of high-risk patients. BACKGROUND: Previous studies indicate that CABG may be superior to PCI for diabetics, but no comparisons have been made for diabetics at high risk for surgery. METHODS: Over five years (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of five risk factors (prior CABG, myocardial infarction within seven days, left ventricular ejection fraction <0.35, age >70 years, or an intra-aortic balloon being required to stabilize) were identified. A total of 781 were acceptable for CABG and PCI, and 454 consented to be randomized. The 1,650 patients not acceptable for both CABG and PCI constitute the physician-directed registry, and the 327 who were acceptable but refused to be randomized constitute the patient-choice registry. Diabetes prevalence was 32% (144) among randomized patients, 27% (89) in the patient-choice registry, and 32% (525) in the physician-directed registry. The CABG and PCI survival rates were compared using Kaplan-Meier curves and log-rank tests. RESULTS: The respective CABG and PCI 36-month survival rates for diabetic patients were 72% and 81% for randomized patients, 85% and 89% for patient-choice registry patients, and 73% and 71% for the physician-directed registry patients. None of the differences was statistically significant. CONCLUSIONS: We conclude that PCI is a relatively safe alternative to CABG for diabetic patients with medically refractory unstable angina who are at high risk for CABG.

Acute and late outcomes of unprotected left main stenting in comparison with surgical revascularization.

OBJECTIVES: The purpose of this study was to compare the early and late results of percutaneous and surgical revascularization of left main coronary artery stenosis. BACKGROUND: Unprotected left main coronary artery (ULMCA) stenting is being investigated as an alternative to bypass surgery. METHODS: We randomly assigned 105 patients with ULMCA stenosis to percutaneous coronary intervention (PCI; 52 patients) or coronary artery bypass grafting (CABG; 53 patients). The primary end point was the change in left ventricular ejection fraction (LVEF) 12 months after the intervention. Secondary end points included 30-day major adverse events (MAE), major adverse cardiac and cerebrovascular events (MACCE), length of hospitalization, target vessel failure (TVF), angina severity and exercise tolerance after 1 year, and total and MACCE-free survival. RESULTS: A significant increase in LVEF at the 12-month follow-up was noted only in the PCI group (3.3 +/- 6.7% after PCI vs. 0.5 +/- 0.8% after CABG; p = 0.047). Patients performed equally well on stress tests, and angina status improved similarly in the 2 groups. PCI was associated with a lower 30-day risk of MAE (p < 0.006) and MACCE (p = 0.03) and shorter hospitalizations (p = 0.0007). Total and MACCE-free 1-year survival was comparable. Left main TVF was similar in the 2 groups. During the 28.0 +/- 9.9-month follow-up, there were 3 deaths in the PCI group and 7 deaths in the CABG group (p = 0.08). CONCLUSIONS: Patients with ULMCA disease treated with PCI had favorable early outcomes in comparison with the CABG group. At 1 year, LVEF had improved significantly only in the PCI group. After more than 2 years, MACCE-free survival was similar in both groups with a trend toward improved survival after PCI.

Midterm outcomes from the TALON Registry: treating peripherals with SilverHawk: outcomes collection.

PURPOSE: To determine midterm clinical outcomes among patients with lower extremity peripheral arterial disease who underwent revascularization with catheter-based plaque excision (PE). METHODS: Between August 2003 and February 2005, 19 institutions participating in the observational, nonrandomized, multicenter TALON registry enrolled 601 consecutive patients (353 men; mean age 70+/-11, range 36-98) with 1258 symptomatic lower extremity atherosclerotic lesions (748 limbs) treated by plaque excision with the SilverHawk catheter. Approximately 50% of the patients had diabetes, and nearly one third of the procedures were indicated for Rutherford ischemia category > or =4. Mean lesion lengths above and below the knee, respectively, were 62.5+/-68.5 mm (interquartile range [IQR], 20.0-80.0) and 33.4+/-42.7 mm (IQR 15.0-37.5). The primary endpoints of the study were target lesion revascularization (TLR) at 6 and 12 months. RESULTS: The device achieved < or =50% residual diameter stenosis in 94.7% of lesions; procedural success was 97.6%. Nearly half (41.9%) of the procedures involved PE of > or =2 lesions. Nearly three quarters (73.3%) of the lesions did not require adjunctive therapy, and stent placement following PE occurred in only 6.3% of lesions. The 6- and 12-month rates of survival free of TLR were 90% and 80%, respectively. Rates of TLR were similar among patients with diabetes (11%) and without diabetes (9%). In the multivariate analysis, significant predictors of TLR at 6 months were a history of MI or coronary revascularization (HR 5.49, 95% CI 1.87 to 16.10, p=0.0008), multiple (> or =2) lesions (HR 1.37, 95% CI 1.11 to 1.70, p=0.0019), and increasing Rutherford category (HR 1.84, 95% CI 1.28 to 2.65, p=0.0003). Lesion length >50 mm was associated with a 2.9-fold increased risk for TLR (HR 2.88, 95% CI 1.18 to 7.01, p=0.012); lesion length >100 mm was associated with a 3.3-fold increase in TLR (HR 3.32, 95% CI 1.15 to 9.56, p=0.016). CONCLUSION: In patients undergoing revascularization for lower extremity atherosclerotic disease, catheter-based PE achieves favorable procedural success and avoids the need for repeat revascularization at midterm follow-up. These findings support PE as a primary endovascular therapy for patients undergoing lower extremity arterial revascularization.

Early and late results of percutaneous revascularization in patients with ischemic cardiomyopathy and decreased left ventricular ejection fraction. (Revascularisation in Heart Failure Trial, REHEAT Registry).

AIMS: REvascularization in Ischaemic HEart Failure Trial (REHEAT) is a registry prospectively evaluating the outcomes of percutaneous myocardial revascularization in postinfarction patients with ischemic cardiomyopathy and various categories of surgical risk. METHODS AND RESULTS: One hundred seventy consecutive postinfarction patients with LVEF <40% and angiographically documented coronary stenoses eligible for PCI were enrolled to the study. The study end-points included: angiographic success of PCI, major adverse events at 30 days and 1 year after procedure, long-term survival, functional status (CCS and NYHA class) and LVEF 12 months after the intervention. Angiographic success rate was 98,8% and complete revascularization was achieved in 38.8% cases. No periprocedural deaths were registered. Thirtieth-days survival was 97% and was better in comparison to calculated survival for CABG patients; 1-year survival was 94.4% and was not inferior to predicted survival after CABG. In the general study population a significant improvement of LVEF (27,8+/-7,0 to 35,9+/-9,4%) was shown (absolute change mean 6.45+/-10%). In low/intermediate risk group the LVEF increase was lower (6.5+/-10,9) in comparison to high risk group (10,3+/-9,6%)(p=0,042). In both groups a significant and comparable reduction of angina and heart failure severity was shown in 1-year follow-up. CONCLUSION: PCI in postinfarction patients with markedly reduced LVEF is associated with a significant increase of LVEF and favorable clinical outcome (CCS and NYHA class). PCI is safe, feasible and can be an alternative approach to CABG both in low/intermediate and high surgical risk patients.