Polymer-based drug-eluting stent treatment extends the time to reintervention for patients with symptomatic femoropopliteal artery disease: clinical evidence and potential economic value.

Aim: Use long-term follow-up data from the IMPERIAL study to determine whether drug-eluting polymer-based nitinol stent treatment can delay the time to repeat intervention for femoropopliteal artery disease and how such a delay may result in cost savings in a value-based episode of care. Patients & methods: The IMPERIAL randomized controlled trial was an international study of a paclitaxel-eluting polymer-coated stent (Eluvia, Boston Scientific, MA, USA) versus a polymer-free paclitaxel-coated stent (Zilver PTX, Cook Corporation, IN, USA) for treating lesions of the femoropopliteal arterial segment. Study patients (n = 465) had symptomatic lower limb ischemia. Safety and efficacy assessments were performed through 5 years. Mean time to first reintervention was calculated in post-hoc analysis for patients who underwent a clinically driven target lesion revascularization (CD-TLR) through 3 or 5 years following the index procedure. To simulate potential cost savings associated with differential CD-TLR burden over time, a cost-avoidance analysis using input parameters from IMPERIAL and US 100% Medicare standard analytical files was developed. Results: Among patients with a first CD-TLR through 3 years of follow-up, mean time to reintervention was 5.5 months longer (difference 166 days, 95% CI: 51, 282 days; p = 0.0058) for patients treated with Eluvia (n = 56) than for those treated with Zilver PTX (n = 30). Through the 5-year study follow-up period, CD-TLR rates were 29.3% (68/232) for Eluvia and 34.2% (39/114) for Zilver PTX (p = 0.3540) and mean time to first reintervention exceeded 2 years for patients treated with Eluvia at 737 days versus 645 days for the Zilver PTX group (difference 92 days, 95% CI: -85, 269 days; p = 0.3099). Simulated savings considering reinterventions occurring over 1 and 5 years following initial use of Eluvia over Zilver PTX were US $1,395,635 and US $1,531,795, respectively, when IMPERIAL CD-TLR rates were extrapolated to 1000 patients. Conclusion: IMPERIAL data suggest initial treatment with Eluvia extends the time patients spend without undergoing reintervention. This extension may be associated with cost savings in relevant time frames.

Intravascular Ultrasound Guidance During Peripheral Vascular Interventions: Long-term Clinical Outcomes and Costs From the Japanese Perspective.

PURPOSE: The value of intravascular ultrasound (IVUS) guidance during peripheral vascular revascularization procedures is incompletely understood. Moreover, data on long-term clinical outcomes and costs are limited. The objective of this study was to compare outcomes and costs between IVUS and contrast angiography alone in patients undergoing peripheral revascularization procedures in Japan. MATERIALS AND METHODS: This retrospective comparative analysis was performed using the Japanese Medical Data Vision insurance claims database. All patients undergoing revascularization for peripheral artery disease (PAD) between April 2009 and July 2019 were included. Patients were followed until July 2020, death, or a subsequent revascularization procedure for PAD. Two patient groups were compared: one undergoing IVUS imaging or the other contrast angiography alone. The primary end point was major adverse cardiac and limb events, including all-cause-mortality, endovascular thrombolysis, subsequent revascularization procedures for PAD, stroke, acute myocardial infarction, and major amputations. Total health care costs were documented over the follow-up and compared between groups, using a bootstrap method. RESULTS: The study included 3956 patients in the IVUS group and 5889 in the angiography alone group. Intravascular ultrasound was significantly associated with reduced risk of a subsequent revascularization procedure (adjusted hazard ratio: 0.25 [0.22-0.28]) and major adverse cardiac and limb events (0.69 [0.65-0.73]). The total costs were significantly lower in the IVUS group, with a mean cost saving over follow-up of $18 173 [$7 695-$28 595] per patient. CONCLUSION: The use of IVUS during peripheral revascularization provides superior long-term clinical outcomes at lower costs compared with contrast angiography alone, warranting wider adoption and fewer barriers to IVUS reimbursement for patients with PAD undergoing routine revascularization. CLINICAL IMPACT: Intravascular ultrasound (IVUS) guidance during peripheral vascular revascularization has been introduced to improve the precision of the procedure. However, questions over the benefit of IVUS in terms of long-term clinical outcome and over cost have limited its use in everyday clinical practice. This study, performed in a Japanese health insurance claims database, demonstrates that use of IVUS provides a superior clinical outcome over the long term at a lower cost compared to angiography alone. These findings should encourage clinicians to use IVUS in routine peripheral vascular revascularization procedures and encourage providers to reduce barriers to use.

IVUS Assessment of the Crossing Pathway of an Intraluminal Reentry Device Used in the Primary Treatment of Infrainguinal Chronic Total Occlusions.

Purpose: To examine with intravascular ultrasound (IVUS) the crossing pathways of the TruePath reentry device during primary antegrade recanalization of infrainguinal chronic total occlusions (CTOs). Methods: Between July 2017 and September 2018, a prospective multicenter study enrolled 143 consecutive patients (mean age 75±9 years; 101 men) with 146 CTOs treated in an antegrade approach using the TruePath reentry device with IVUS assessment of the crossing pathway in successful cases. Outcome measures were complete success (reentry device reached the distal true lumen), assisted success (reentry device use followed by a conventional guidewire to reach the distal true lumen), reentry device crossing route by IVUS assessment, and procedure- and device-related complications. Regression analyses were employed to identify any relevant associations between baseline patient variables and the outcome measures; results are presented as the odds ratio (ORs) and 95% confidence interval (CI). Results: Complete success was achieved in 82 (56.2%) lesions; any success (complete plus assisted) was documented in 117 (80.1%) lesions. Four (3%) perioperative device-related complications were observed. The crossing route was intraplaque for most of the total crossing distance in both complete success cases (95.3%±13.2%) and any success cases (94.8%±14.4%), with relatively short subintimal (3.6%±10.2% and 4.2%±11.2%, respectively) or intramedial (1.2%±5.8% and 1.0%±5.4%, respectively) crossing. CTO length was a significant risk factor for not achieving complete success (OR 1.74, 95% CI 1.13 to 2.68, p=0.012), and a history of failed revascularization was associated with not achieving any success (OR 6.40, 95% CI 1.28 to 28.9, p=0.038). Conclusion: The intraplaque route was the primary pathway taken by the TruePath reentry device as it crossed infrainguinal CTOs. Crossing rates were acceptable, with few device-related complications. However, a longer CTO length and a failed revascularization history negatively affected the success rate.

Length and Cost of Hospital Stay in Poor-Risk Patients With Critical Limb Ischemia Undergoing Revascularization.

BACKGROUND: The aim of the current study was to identify the distribution of length and cost of hospital stay and their associated risk factors in poor-risk Japanese critical limb ischemia (CLI) patients undergoing revascularization. Methods and Results: We analyzed prospectively collected data from 507 CLI patients who required assistance in their daily lives due to disability in activities of daily living and/or cognitive function impairment and who underwent revascularization. The median length and cost of hospital stay were 23 days (IQR, 9-52 days) and ¥2.25m (IQR, ¥1.33m-3.58m), respectively. Reduced albumin, tissue loss, infection, surgical reconstruction, and bilateral revascularization were associated with prolonged hospital stay (P=0.012, 0.019, <0.001, <0.001, and <0.001, respectively). Doubling the length of the hospital stay was associated with a 44% increase in hospital cost. Regular dialysis, surgical reconstruction, and bilateral revascularization were independently associated with an approximately 20% increase in the cost of hospital stay (all P<0.001). CONCLUSIONS: Length and cost of hospital stay varied considerably between patients. Low serum albumin, tissue loss, infection, surgical reconstruction, and bilateral revascularization were associated with longer hospital stay. Regular dialysis, surgical reconstruction, and bilateral revascularization were independently associated with an approximately 20% increase in the cost of hospital stay.

Prognostic Impact of Revascularization in Poor-Risk Patients With Critical Limb Ischemia: The PRIORITY Registry (Poor-Risk Patients With and Without Revascularization Therapy for Critical Limb Ischemia).

OBJECTIVES: The authors sought to investigate the prognostic impact of revascularization for poor-risk CLI patients in real-world settings. BACKGROUND: Critical limb ischemia (CLI) is often accompanied with various comorbidities, and frailty is not rare in the population. Although previous studies suggested favorable outcomes of revascularization for CLI patients, those studies commonly included the healthier, that is, less frail patients. METHODS: This was a multicenter prospective observational study, registering patients who presented with CLI and who required assistance for their daily lives because of their disability in activities of daily living (ADL) and/or impairment of cognitive function. Revascularization was either planned (revascularization group) or not planned (non-revascularization group). The primary endpoint was 1-year survival, and was compared between the revascularization and non-revascularization groups, using the propensity score-matching method. RESULTS: Between January 2014 and April 2015, a total of 662 patients were registered, of those 100 non-revascularization patients were included. A total of 625 patients (94.4%) completed the 1-year follow-up. Death was observed in 223 patients (33.7%). After propensity score matching, the 1-year survival rate was 55.9% in the revascularization group versus 51.0% in the non-revascularization group, with no significant difference (p = 0.120). In the subgroups alive at 1 year after revascularization, health-related quality of life was significantly improved compared with baseline, whereas ADL scores were unchanged from baseline and still remained significantly worse than before CLI onset. CONCLUSIONS: The 1-year overall survival rate was not significantly different between the revascularization and non-revascularization groups in poor-risk CLI patients. (Poor-Risk Patients With and Without Revascularization Therapy for Critical Limb Ischemia; [PRIORITY Registry]; UMIN000012871).

Utility of new classification based on clinical and lesional factors after self-expandable nitinol stenting in the superficial femoral artery.

BACKGROUND: The aim of this study was to investigate the predictive value of clinical classification schemes that assess primary patency after self-expandable nitinol stent in the superficial femoral artery (SFA). METHODS: This study was a multicenter retrospective study of prospective databases. From April 2004 to December 2009, 1001 limbs (807 patients) that underwent successful nitinol stent implantation for de novo SFA lesions were identified and analyzed. Primary patency was defined as treated vessel without restenosis (defined as >2.4 of peak systolic velocity ratio by duplex) and repeat revascularization. Six items were included in the classification: female, diabetes, dialysis, critical limb ischemia (CLI), lesion length > 150 mm, and poor runoff; the FeDCLIP score. A lesion length >150 mm was scored as 2 points. The others were assigned 1 point each. The scores of 0 to 2, 3 to 4, and ≥5 points were classified as low-, moderate-, and high-risk patients, respectively. Outcome measures were primary and secondary patency and all-cause mortality up to 6 years in each risk group. RESULTS: The mean follow-up interval was 26.8 ± 14.6 months. Primary patencies were 85.7%, 77.3%, and 74.2% in the low-risk group; 71.5%, 54.7%, and 51.9% in the moderate-risk group; and 53.0%, 24.3%, and 20.8% in the high-risk group at 1, 3, and 5 years, respectively. The secondary patencies were 94.6%, 92.3%, and 90.8% in the low-risk group; 89.5%, 83.1%, and 83.1% in the moderate-risk group; and 82.7%, 73.1%, and 73.1% in the high-risk group at 1, 3, and 5 years, respectively. There were significant differences in primary and secondary patency among the three risk groups (P < .0001 and P < .0001, respectively). Overall survival rates were 96.8%, 89.5%, and 81.8% in the low-risk group; 91.5%, 74.4%, and 68.7% in the moderate-risk group; and 78.2%, 63.2%, and 48.7% in the high-risk group at 1, 3, and 5 years, respectively. There were also significant differences in mortality (P < .0001). CONCLUSIONS: New classification schemes based on FeDCLIP score were useful for risk stratification in vessel patency and mortality after self-expandable nitinol stenting for SFA disease.

Efficacy of fluid assessment based on intrathoracic impedance monitoring in patients with systolic heart failure.

BACKGROUND: Previous studies have demonstrated that intrathoracic impedance monitoring (IIM) is associated with fluid overload. However, it remains unclear whether this new technology can predict heart failure (HF) before deterioration. Whether fluid status based on IIM predicts HF in patients with left ventricular (LV) systolic dysfunction was investigated. METHODS AND RESULTS: A prospective clinical observational study of 123 patients implanted with IIM-capable cardiac devices was carried out. The primary endpoint was the positive predictive value (PPV) at 12 months. Secondary endpoints were a correlation between onset of HF and IIM, optimal threshold of fluid index and duration between the alert and HF. Complete follow-up clinical data were obtained from 111 patients. During the observational period, 168 alerts were confirmed from 68 patients. In patient-based analysis (alert-based analysis), PPV was 33.8% (33.9%). Sensitivity, specificity and false positive was 67.6% (83.8%), 49.4% (28.4%) and 50.6% (71.6%), respectively. Mean duration between the alert and HF event was 21.4 ± 6.1 days. On multivariate logistic analysis, maximum fluid index, LV ejection fraction and atrial fibrillation were independent predictors of HF events. The optimal cut-off value determined by receiver operating characteristic curve was 114-ohm·day with sensitivity and specificity of 89.5% and 73.0%, respectively. CONCLUSIONS: IIM-based fluid index in patients with HF due to LV systolic dysfunction was effective in predicting worsening HF.