Kaplan-Meier Estimates Of Freedom Research Articles

BioMimics 3D vascular stent system for femoropopliteal interventions

Summary: Background: The MIMICS-3D study aimed to assess the safety and effectiveness of the BioMimics 3D Vascular Stent System for the treatment of symptomatic femoropopliteal artery disease in a real-world patient population. Patients and methods: Consecutive participants who were scheduled for implantation of the BioMimics 3D stent were enrolled in the prospective, observational, multicenter study. The primary effectiveness outcome was freedom from clinically driven target lesion revascularization at 12 months and the primary safety outcome was a composite of major adverse events comprising death, major target limb amputation, or clinically driven target lesion revascularization at 30 days. Outcomes through 24 months are reported. Results: A total of 507 patients (70±10 years, 65.5% male sex) were enrolled and treated with the study stent. 24.0% had critical limb-threatening ischemia, lesion length was 127±92 mm, and 56.8% of lesions were totally occluded. The Kaplan-Meier (KM) estimate of freedom from clinically driven target lesion revascularization at twelve-months was 90.6% (95% CI: 87.9%–93.3%) and the 30-day primary safety outcome occurred in 1.2% (95% CI: 0.5%–2.7%) of participants. At 24 months, clinical improvement was achieved in 86.6% and the KM estimate of freedom from clinically driven target lesion revascularization was 82.8% (95% CI: 79.4%–86.4%). The KM estimate of freedom from loss of primary patency according to PSVR >2.4 was 78.6% (95% CI: 74.7%–82.4%). Survival distribution functions regarding primary patency were lower with long lesions (>150 mm; log-rank p<0.001) but did not differ significantly between participants with or without critical limb-threatening ischemia (log-rank p=0.07). Conclusions: Endovascular treatment of atherosclerotic femoropopliteal lesions with the BioMimics 3D Vascular Stent System is efficacious and safe in a real-world setting.

Impact of right ventricular dysfunction after MitraClip treatment as a bridge to heart transplantation: insights from the MitraBridge registry

Abstract Background MitraClip treatment has been recently proposed as a “bridge strategy” solution for advanced heart failure (HF) patients with significant functional mitral regurgitation (MR), who are potential candidates or are waiting for cardiac replacement therapy (LVAD or heart transplantation, HTx). In this clinical scenario, left-ventricular-related right ventricular dysfunction (RVD) represents an important prognostic factor. Purpose Our study aimed to investigate the possible prognostic implication of RVD in advanced HF patients treated with MitraClip as a bridge to HTx strategy. Methods RVD was assessed using the relationship between tricuspid annular peak systolic excursion (TAPSE) and pulmonary artery systolic pressure (PASP). All patients from the MitraBridge registry for whom these two echocardiographic parameters were available, were included in the study. A cut-off value of TAPSE/PASP ratio <0.36 was used to defined RVD, as previously reported. The primary outcome was a composite end-point of all-cause death or rehospitalization for HF at 2-year. For patients who underwent LVAD implantation or HTx, follow-up data were censored at the time of those events. Results A total of 80 patients were included in the study. The median TAPSE/PASP ratio was 0.35 (25th-75th: 0.27–0.46), with 43 (54%) patients having a TAPSE/PASP ratio <0.36 (RVD group). The latter had a prevalent MR ischemic etiology (49% vs 38%), with a more frequent history of percutaneous coronary intervention (46.5% vs 22%, p=0.02). Except for TAPSE (15.7±3.6 mm vs 19.2±3.7 mm, p=0.001) and PASP (61±14 mmHg vs 39.5±9.5 mmHg, p<0.001), the other echocardiographic characteristics were similar between the two study groups (overall mean left ventricular ejection fraction 26.9±8%, median left ventricular end-diastolic volume index 120.7, 25th-75th: 102.2–146.5 mL/m2). After a median follow-up time of 508 (25th-75th: 160–899) days, elective HTx occurred in 12 patients (7 from the RVD group), while LVAD implantation was performed in 13 patients (7 from the RVD group). The primary outcome occurred in 30 patients (38%) with a 2-year Kaplan-Meier estimate of freedom from the composite end-point of 41%. At univariate (HR 1.3 95% CI 0.6–2.8, p=0.451) and multivariate (HR 1.6 CI 0.7–3.8, p=0.249) Cox-regression analysis, TAPSE/PASP ratio <0.36 was not identified as an independent predictor of primary outcome. Indeed, at follow-up echocardiographic control (median time 252, 25th-75th: 122–365 days), a significant improvement in TAPSE/PASP ratio was observed in the RVD group (baseline median TAPSE/PASP ratio 0.27, 25th-75th: 0.22–0.32 vs follow-up median TAPSE/PASP ratio 0.37, 25th-75th: 0.28–0.47, p<0.001). Conclusion In advanced HF patients with functional MR, MitraClip treatment could prevent or ameliorate left-ventricular-related RVD, allowing safe access to HTx or LVAD. Funding Acknowledgement Type of funding sources: None.

Impact of brain natriuretic peptide for predicting long-term life expectancy and cardiovascular or limb events in peripheral arterial disease.

Brain natriuretic peptide (BNP) is introduced as a predictor of the degree of ventricular dysfunction and is associated with mortality. There are limited reports on the relationship of BNP with long-term all-cause death (AD) and cardiovascular or limb events in peripheral artery disease (PAD). We examined the relationship between BNP level and these events in PAD patients. We performed a prospective cohort study in 938 PAD patients. The patients were divided into four groups based on BNP levels with median (interquartile range): Q1: ≤20.4; Q2: 20.5-42.8; Q3: 42.9-103.4; and Q4: ≥103.5 pg/mL. The endpoints were AD, freedom from major adverse cardiovascular events (MACE), and MACE plus limb events (MALE). The median follow-up time was 65 months. There were 383 deaths (40.8%) during follow-up period. AD depended on BNP levels (P<0.01), with 5-year freedom from AD rates of Q1: 94%, Q2: 84%, Q3: 69%, and Q4: 55%. The Kaplan-Meier estimates of freedom from AD, MACE, and MALE had significant differences among Q1- Q4 groups (P<0.001). In multiple regression analysis, BNP had significant negative correlations with eGFR, serum albumin, and BMI and positive correlations with diabetes (P<0.05). In Cox multivariate analysis, higher BNP, age, CRP, D-dimer, lower BMI, ABI, serum albumin, and eGFR were related to AD; and higher BNP, age, lower ABI, serum albumin, CAD, and DM were related to MACE and MALE (P<0.05). Statins improved AD, MACE, and MALE (P<0.01). BNP was a promising biomarker for AD, MACE, and MALE in patients with PAD.

Treatment of Femoropopliteal Lesions With the BioMimics 3D Vascular Stent System: Two-Year Results From the MIMICS-2 Trial

Purpose To report the safety and effectiveness outcomes through 2 years of the BioMimics 3D Vascular Stent System in the treatment of symptomatic patients with atherosclerotic femoropopliteal disease. Materials and Methods The tubular, nitinol BioMimics 3D stent, which was designed to impart a helical shape to the arterial segment, was implanted in 271 patients (mean age 68.4±9.5 years; 180 men) with de novo femoropopliteal lesions enrolled at 43 investigational sites [31 US (n=162), 6 German (n=78), and 6 Japanese (n=31)] in the prospective, single-arm MIMICS-2 investigational device exemption trial (ClinicalTrials.gov identifier NCT02400905) between June 2015 and October 2016. Mean lesion length was 81.2±38.4 mm, 30.0% of patients had total occlusions, and 45.9% had moderate to severe calcification. Primary safety and effectiveness endpoints were compared at 1 year with prespecified objective performance goals (OPGs) set by the VIVA Physicians organization. Outcomes through 2 years are reported. Results The primary effectiveness endpoint of 12-month primary stent patency was met by 182 of 249 patients (73.1%, 95% CI 67.3% to 78.2%), exceeding the OPG of 66%. The primary safety endpoint of 30-day freedom from major adverse events (MAEs) was met in 268 of 269 patients (99.6%, 95% CI 97.7% to 100%), exceeding the OPG of 88%. Kaplan-Meier estimates of freedom from loss of primary patency were 83.1% at 12 months and 70.2% at 24 months, freedom from MAEs estimates were 86.9% at 12 months and 79.2% at 24 months, and freedom from clinically-driven target lesion revascularization estimates were 88.0% at 12 months and 83.0% at 24 months. At 24 months, 88.2% of patients showed improvement of ≥1 Rutherford category; the ankle-brachial index was >0.9 for 64.4% vs 11.3% at baseline. There were no cases of stent fracture. Conclusion Through 24 months, the BioMimics 3D Vascular Stent System provided safe and effective treatment for femoropopliteal lesions in patients with symptomatic peripheral artery disease.

Positive Clinical Benefit on Patient Care, Quality of Life, and Symptoms After Contact Force-Guided Radiofrequency Ablation in Persistent Atrial Fibrillation: Analyses From the PRECEPT Prospective Multicenter Study.

There is limited evidence on the long-term clinical benefits of catheter ablation in patients with persistent atrial fibrillation. PRECEPT was a prospective, multicenter, single-arm Food and Drug Administration-regulated investigational device exemption clinical study. Patients were followed up to 15 months after ablation. Outcomes included use of antiarrhythmic drugs, rate of cardioversions and cardiovascular hospitalization, Atrial Fibrillation Effect on Quality-of-Life score, and Canadian Cardiovascular Society Severity of Atrial Fibrillation score. A total of 333 enrolled persistent atrial fibrillation patients underwent ablation. The cardioversion rate decreased by 83% at the 9- to 15-month follow-up. Antiarrhythmic drug utilization decreased by 69% at 12 to 15 months post-ablation. The Kaplan-Meier estimate of freedom from cardiovascular hospitalization was 84.2% (95% CI, 80.2%-88.2%) at 15 months. Consistent improvements in mean Atrial Fibrillation Effect on Quality-of-Life composite (+50.0) were seen at 6 months, sustained at 15 months, and exceeded the minimum clinically important difference. Improvements in Atrial Fibrillation Effect on Quality-of-Life scores were significantly better among participants without documented atrial arrhythmia recurrences. By Canadian Cardiovascular Society Severity of Atrial Fibrillation symptom classification, >80% of patients were asymptomatic (class 0) at 15 months post-ablation compared with only 0.7% at baseline. Contact force-guided radiofrequency ablation of persistent atrial fibrillation was associated with a significant decrease in antiarrhythmic drug use, cardioversion rate, and hospitalization. Clinically meaningful improvements in quality of life were observed in all patients. The majority of the patients (>80%) were asymptomatic at 15 months post-ablation. The positive clinical impact of improved quality of life and reduced health care utilization may help with shared decision-making in persistent atrial fibrillation treatment. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02817776.

Positive clinical benefit on patient care, quality of life and symptoms after radiofrequency ablation with contact force in persistent atrial fibrillation: analyses from PRECEPT

Abstract Background The management of persistent (PsAF) aims to prevent AF recurrence and associated disabilities while reducing side effects from treatment. Contact force (CF)-guided RF catheters have proven efficacious and safe for pulmonary vein isolation (PVI) to treat paroxysmal AF; however, there is limited evidence on clinical benefits with ablation of PsAF. Purpose To assess long-term clinical effects on patients care, symptoms and QOL after CF-guided RF ablation in PsAF. Methods PRECEPT was a multicenter study evaluating the safety and efficacy of CF RF catheters in the treatment of symptomatic PsAF (NCT02817776). PVI was performed with or without substrate modification. Patients were followed at 6, 9, 12 and 15 mos to collect the following data: Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score, Canadian Cardiovascular Society Severity of Atrial Fibrillation (CCS-SAF) score, Class I/III AAD use, and incidence of cardioversion and cardiovascular hospitalization. Results A total of 333 enrolled patients (65.4±8.8 yrs, 71.2% male, CHA2DS2-VASC score 2.3±1.5) underwent PVI. Compared to baseline, 1) improvements in the AFEQT composite and subscores were seen from 6–15 mos, exceeding Clinical Important Difference (±5 points) in majority of subjects (Figure), 2) proportion of CCS-SAF Class 0 patients (asymptomatic with respect to AF) rose from 0.7% to 81.0%, 3) class I/III AAD use was reduced from 97.0% to 24.7%, and 4) incidence of cardioversion decreased from 62.0% to 10.7%. Moreover, the 1-yr Kaplan-Meier estimate of freedom from hospitalization was 84.2% [95% CI: 80.2%, 88.2%]. Conclusion CF-guided RF ablation in PsAF patients led to a clinically meaningful improvement in QOL, as well as a reduction in AAD use, cardioversion, and hospitalization. Figure 1. Mean AFEQT composite and subscore Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This study was funded by Biosense Webster, Inc.

Three-Year Outcomes From the LIBERTY 360 Study of Endovascular Interventions for Peripheral Artery Disease Stratified by Rutherford Category

Purpose: To report the 3-year results of the LIBERTY 360 study, which investigated outcomes of endovascular treatment of symptomatic peripheral artery disease (PAD). Materials and Methods: The LIBERTY trial (ClinicalTrials.gov identifier NCT01855412) was a prospective, observational, core laboratory–assessed, multicenter study of endovascular interventions enrolling >1200 participants treated at 51 sites. Data from 1189 patients were stratified according to Rutherford category (RC) and analyzed [RC 2-3 (n=500), RC 4-5 (n=589), and RC 6 (n=100)]. The primary outcomes were major amputation of the target limb and all-cause death; secondary outcomes were target vessel revascularization (TVR) or target lesion revascularization (TLR); major adverse events (MAEs; death within 30 days, TVR or TLR, and major amputation); death or major amputation combined; and change in self-reported quality of life (QoL) measures (VascuQol-25). The Kaplan-Meier (KM) method was employed to estimate the outcomes; estimates are presented with the 95% confidence intervals (CI). Predictors of 3-year MAE, death, TVR, and major amputation were analyzed using Cox proportional hazard regression modeling. Results: The 36-month KM survival rates were 86.0% in RC 2-3, 79.8% in RC 4-5, and 62.0% in RC 6 groups. The KM estimates of freedom from major amputation at 36 months were 98.5% in RC 2-3, 94.0% in RC 4-5, and 79.9% in RC 6. The 36-month KM estimates for freedom from TVR/TLR were 71.1% in RC 2-3, 64.2% in RC 4-5 and 61.9% in RC 6 groups. Patients with claudication at baseline were at lower risk for MAEs compared with RC 4-5 and RC 6 patients during the 36-month follow-up. Vascular QoL improved from baseline and persisted up to 36 months in all patients. Conclusion: Endovascular therapy is a viable treatment option for patients with symptomatic PAD, with sustained improved quality of life in both claudicants and patients with chronic limb-threatening ischemia. These results provide important point estimates for midterm outcomes after modern endovascular interventions for PAD.

Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Cohort

Multicenter, prospective single-arm IN.PACT Global Study from 2012 to 2014 There were 1406 patients with claudication (89%) or rest pain (11%) with complex femoropopliteal occlusive lesions who were treated with IN.PACT Admiral drug-coated balloon (DCB) angioplasty (Medtronic, Dublin, Ireland). Mean lesion length was 12 cm, and a third of the lesions were occluded. The Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization through 36 months was significantly lower in patients with chronic limb-threatening ischemia (68%) compared with claudicants (78%). Predictors of clinically driven target lesion revascularization through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, and chronic limb-threatening ischemia. DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease to treat complex lesions in a real-world population is associated with sustained clinical efficacy and low rates of reintervention at 3 years after the initial procedure.

MitraClip in secondary mitral regurgitation as a bridge to heart transplantation: 1-year outcomes from the International MitraBridge Registry

Patients awaiting heart transplantation (HTx) often need bridging therapies to reduce worsening and progression of underlying disease. Limited data are available regarding the use of the MitraClip procedure in secondary mitral regurgitation for this clinical condition. We evaluated an international, multicenter (17 centers) registry including 119 patients (median age: 58 years) with moderate-to-severe or severe secondary mitral regurgitation and advanced heart failure (HF) (median left ventricular ejection fraction: 26%) treated with MitraClip as a bridge strategy according to 1 of the following criteria: (1) patients active on HTx list (in list group) (n = 31); (2) patients suitable for HTx but awaiting clinical decision (bridge to decision group) (n = 54); or (3) patients not yet suitable for HTx because of potentially reversible relative contraindications (bridge to candidacy group) (n = 34). Procedural success was achieved in 87.5% of cases, and 30-day survival was 100%. At 1 year, Kaplan-Meier estimates of freedom from the composite primary end-point (death, urgent HTx or left ventricular assist device implantation, first rehospitalization for HF) was 64%. At the time of last available follow-up (median: 532 days), 15% of patients underwent elective transplant, 15.5% remained or could be included in the HTx waiting list, and 23.5% had no more indication to HTx because of clinical improvement. MitraClip procedure as a bridge strategy to HTx in patients with advanced HF with significant mitral regurgitation was safe, and two thirds of patients remained free from adverse events at 1 year. These findings should be considered exploratory and hypothesis-generating to guide further study for percutaneous intervention in high-risk patients with advanced HF.

JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study

Purpose: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). Materials and Methods: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR (ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI). Results: Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively. Conclusion: JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR.

Atrial fibrillation post central retinal artery occlusion: Role of implantable loop recorders.

This study evaluated the risk of subclinical atrial fibrillation (AF) in patients with central retinal artery occlusion (CRAO) compared to those with cryptogenic stroke using implantable loop recorders (ILR). We conducted a retrospective analysis of 273 consecutive patients who had ILRs inserted at our institution for either cryptogenic stroke (n=227) or CRAO (n=46). Our primary endpoint was a time to event analysis for the new diagnosis of AF by ILR. Univariable and multivariable Cox proportional hazard models were used to determine the predictors of time-to-AF. A total of 64 patients were found to have newly diagnosed AF by remote monitoring of the ILR. AF was detected in 57 of 227 (25%) cryptogenic stroke patients by the end of a maximum 5.1 years follow-up and in seven of 46 (15%) CRAO patients by the end of a maximum 3.6 years follow-up (P=.215, log-rank test). The Kaplan-Meier estimates for freedom from AF was 59.4% for CRAO and 66.6% for cryptogenic stroke (P=NS, log-rank test). Baseline variables predicting AF included older patients, higher CHADS2 VASC score, longer PR interval on initial EKG evaluation, and mitral annular calcification on transthoracic echocardiogram. Patients with CRAO are at risk for subclinical AF, similar to those with cryptogenic stroke. Long-term monitoring to detect AF may lead to changes in pharmacotherapy to reduce the risk for subsequent stroke.

Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort

Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.

Comparison of Two Iliac Branch Devices and Their Midterm Performance in Maintaining Blood Flow to the Internal Iliac Artery

Purpose: To compare and contrast the midterm outcomes of the E-liac and Zenith (ZBIS) iliac branch devices (IBDs) for the preservation of the internal iliac artery (IIA) in aneurysms involving the iliac bifurcation. Materials and Methods: Between January 2014 and December 2018, 84 consecutive patients (median age 74 years; 76 men) were electively treated with the E-liac (n=44) or ZBIS (n=40) IBDs and were retrospectively analyzed to evaluate the technical success, patency, need for reintervention, and mortality associated with these devices. Results: Technical success was achieved in 95 of 99 implantations (95.9%) without any statistically significant difference between the groups (93.7% vs 98.0%, p=0.114). During the first 30 days, 3 occlusions in the ZBIS group and 1 in the E-liac group were identified. There was 1 perioperative death in the ZBIS group. The median follow-up was 37 months for the ZBIS group and 28 months for the E-liac group (p=0.657). Six patients from the ZBIS group and 7 from the E-liac group were lost to follow-up. Among the remaining, there were 2 further deaths recorded, 1 in each group. Four further reinterventions in the E-liac group and 2 in the ZBIS group were performed during follow-up. The Kaplan-Meier estimates of freedom from reintervention were 87.2% (95% CI 82.6% to 90.2%) for the ZBIS group and at 86.0% (95% CI 83.7% to 89.1%) for the E-liac group (p=0.563); the freedom from occlusion estimates were 89.7% (95% CI 85.8% to 94.5%) and 95.3% (95% CI 92% to 98.7%; p=0.317), respectively. Conclusion: The E-liac and the ZBIS IBDs showed equally high technical success, midterm patency, and low reintervention rates.

Long-term safety and effectiveness of paroxysmal atrial fibrillation ablation using a porous tip contact force-sensing catheter from the SMART SF trial

PurposeThe prospective, multicenter SMART SF trial demonstrated the acute safety and effectiveness of the 56-hole porous tip irrigated contact force (CF) catheter for drug-refractory paroxysmal atrial fibrillation (PAF) ablation with a low primary adverse event rate (2.5%), leading to FDA approval of the catheter. Here, we are reporting the long-term effectiveness and safety results that have not yet been reported.MethodsAblations were performed using the 56-hole porous tip irrigated CF catheter guided by the 3D mapping system stability module. The primary effectiveness endpoint was freedom from atrial tachyarrhythmia (including atrial fibrillation, atrial tachycardia, and/or atrial flutter), based on electrocardiographic data at 12 months. Atrial tachyarrhythmia recurrence occurring 3 months post procedure, acute procedural failures such as lack of entrance block confirmation of all PVs, and undergoing repeat procedure for atrial fibrillation in the evaluation period (91 to 365 days post the initial ablation procedure) were considered to be effectiveness failures.ResultsSeventy-eight patients (age 64.8 ± 9.7 years; male 52.6%; Caucasian 96.2%) participated in the 12-month effectiveness evaluation. Mean follow-up time was 373.5 ± 45.4 days. The Kaplan-Meier estimate of freedom from 12-month atrial tachyarrhythmia was 74.9%. Two procedure-related pericardial effusion events were reported at 92 and 180 days post procedure. There were no pulmonary vein stenosis complications or deaths reported through the 12-month follow-up period.ConclusionsThe SMART SF 12-month follow-up evaluation corroborates the early safety and effectiveness success previously reported for PAF ablation with STSF.

One-year results from the DETOUR I trial of the PQ Bypass DETOUR System for percutaneous femoropopliteal bypass

ObjectiveThe objective of this study was to evaluate the 1-year safety and effectiveness outcomes associated with the PQ Bypass DETOUR System (PQ Bypass, Milpitas, Calif) for the percutaneous bypass of long-segment femoropopliteal occlusive disease. MethodsThis prospective, single-arm, multicenter trial enrolled patients with long-segment femoropopliteal arterial disease. The DETOUR System percutaneously deploys modular stent grafts to bypass femoropopliteal lesions through a transvenous route. Eligible patients included those with TransAtlantic Inter-Society Consensus C and D lesions >100 mm in length. The primary safety end point was the major adverse event (MAE) rate through 1 month, defined as the composite of death, clinically driven target vessel revascularization (CD-TVR), or major amputation. The primary effectiveness end point was stent graft patency through 6 months, defined as freedom from stenosis ≥50%, occlusion, or CD-TVR. ResultsDuring a 24-month period, 78 patients (82 limbs) were enrolled. The average core laboratory-measured lesion length was 371 ± 55 mm; 79 of 82 lesions (96%) were chronic total occlusions, and 55 of 82 lesions (67%) had severe calcification. The rates of technical and procedural success measured during the index procedure were both 96%, with satisfactory delivery and deployment of the device without MAEs in 79 of 82 limbs. Through 1 month, there were no deaths or amputations; CD-TVRs occurred in 2 of 81 limbs (3%), and freedom from MAEs was 98% (79/81). The 1-year Kaplan-Meier primary, assisted primary, and secondary patency rates were 81% ± 4%, 82% ± 4%, and 90% ± 3%, respectively. The ankle-brachial index increased an average of 0.25 ± 0.27 between baseline and 1 year (P < .001). Through 1 year, the Kaplan-Meier estimates of freedom from stent graft thrombosis, CD-TVR, and MAE were 84% ± 4%, 85% ± 4%, and 84% ± 4%, respectively. At 1 year, the Rutherford class improved in 77 of 80 limbs (96%), and 65 of 80 (81%) were asymptomatic. Deep venous thrombosis developed in 2 of 79 target limbs (3%) through 1 year, both at the femoropopliteal vein level. There were no instances of pulmonary embolism. ConclusionsThe 1-year results from the DETOUR I trial show that the PQ Bypass DETOUR System is a safe and effective percutaneous treatment option for patients with longer, severely calcified, above-knee femoropopliteal lesions.

Five-year extension study of patients from a randomized clinical trial (VeClose) comparing cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins

ObjectiveThe proprietary cyanoacrylate closure (CAC) system vs radiofrequency ablation (RFA) trial (VenaSeal Sapheon Closure System Pivotal Study [VeClose]) showed that CAC, a nontumescent, nonthermal, nonsclerosant ablation technique, was effective and noninferior to RFA in vein closure with good 36-month outcomes. Conducted under a separate protocol, the aim of this extended follow-up was to assess the long-term safety and effectiveness of CAC and RFA for the treatment of incompetent great saphenous veins (GSV) at 5 years (60 months) of follow-up. MethodsThis 60-month extension study was conducted for all patients who completed the randomized VeClose study and who were willing to participate. The pivotal VeClose study included patients with symptomatic moderate to severe varicosities (Clinical, Etiology, Anatomy, and Pathophysiology [CEAP] class C2-C4b) and symptomatic GSV incompetence who were randomly assigned (1:1) to either CAC or RFA. The primary outcome measure of this 60-month extension study was complete closure of the target vein, with planned exploratory analysis of noninferiority. Secondary outcomes included CEAP class; completion of the Venous Clinical Severity Score, EuroQol-Five Dimension survey, and Aberdeen Varicose Vein Questionnaire; patient satisfaction with treatment; adverse events (AEs) related to target GSV; and details of adjunctive procedures. ResultsA total of 89 patients completed the 60-month visit, which included 47 from the CAC group, 33 from the RFA group, and 9 CAC roll-in patients. No new recanalization events have been observed in the groups between 36 and 60 months of follow-up. At 60 months, Kaplan-Meier estimates for freedom from recanalization in the randomized CAC and RFA groups were 91.4% and 85.2%, respectively, demonstrating noninferiority of CAC compared with RFA. Both groups demonstrated sustained improvements in EuroQol-Five Dimension and quality of life measures through 60 months. Whereas patients assigned to C0 or C1 clinical class were excluded from the original study, more than half of all returning patients (64% [57/89]) were now assigned to C0 or C1, suggesting an improved clinical class from baseline. Furthermore, 41.1% of returning CAC patients and 39.4% of returning RFA patients are presently at least two CEAP clinical classes lower than at baseline. No long-term device- or procedure-related serious AEs occurred in either group between 36- and 60-month follow-up. ConclusionsCAC and RFA were effective in achieving complete target vein closure of the GSV at long-term follow-up, with CAC demonstrating continued noninferiority to RFA. CAC was also associated with sustained improvements in symptoms and quality of life, lower CEAP class, and high level of patient satisfaction without serious AEs between 36 and 60 months.

Results of fenestrated and branched endovascular aortic aneurysm repair after failed infrarenal endovascular aortic aneurysm repair

ObjectiveFailure of infrarenal endovascular aneurysm repair (EVAR) due to loss of proximal seal is increasingly common. Open surgical conversion can be challenging and has been associated with significant morbidity and mortality. The aim of this study was to evaluate the use of fenestrated-branched EVAR (F/BEVAR) for the treatment of patients with prior EVAR failure. MethodsConsecutive patients enrolled as part of the Aortic Research Consortium in six prospective, nonrandomized, physician-sponsored investigational device exemption studies evaluating F/BEVAR between 2012 and 2018 were included in this study. The cohort was stratified according to whether the F/BEVAR procedure was performed after EVAR failure. Demographics, operative details, perioperative complications, and length of stay were compared between groups. Postprocedural survival, type I or type III endoleak, target artery patency, target artery instability, and reintervention rates were calculated using Kaplan-Meier method and compared between groups. ResultsA total of 893 patients underwent F/BEVAR; 161 (18%) were treated after failed EVAR and 732 (82%) were treated without prior EVAR. Patients with failed EVAR were more often men (84% vs 66%; P < .01) with larger aneurysms (6.9 cm vs 6.4 cm; P < .01). There were no differences in aneurysm extent (P = .20) between groups; for the entire cohort, there were 19% juxtarenal, 9.2% suprarenal, and 72% thoracoabdominal aneurysms. The average number of targeted arteries per patient was 3.6 in both groups. The procedural technical success (99% vs 97%; P = .15) did not differ between groups, but radiation dose (4750 vs 2920 mGy; P = .02), dose-area product (154,572 vs 82,842 mGy·cm2; P < .01), and operative time (5.2 vs 4.6 hours; P < .01) were significantly higher in the failed EVAR group. Median intensive care unit length of stay (2.9 days) and total length of stay (6.3 days) did not differ between groups. The 30-day mortality rate (failed EVAR, 2.5%; no EVAR, 1.1%; P = .25) and 30-day major adverse event rates did not differ between groups. Kaplan-Meier estimates of freedom from type I or type III endoleak (91.9% vs 92.5%; P = .65), target artery patency (97.3% vs 97.0%; P = .91), freedom from target artery instability (86.3% vs 88.8%; P = .53), and freedom from reintervention at 1 year (84.7% vs 88.7%; P = .10) did not differ between the failed EVAR and no EVAR groups, respectively. One-year survival was decreased in the failed EVAR group (86.3% vs 91.9%; P = .02), but this effect did not persist on multivariable analysis (hazard ratio, 1.52; 95% confidence interval, 0.88-2.62; P = .14). ConclusionsIn this multicenter study, F/BEVAR was safe and effective in patients with prior failed EVAR, with nearly identical outcomes to those of patients without prior EVAR. However, differences in procedural metrics indicate higher level of technical challenge in performing F/BEVAR in patients with prior failed EVAR.

Proper technical procedures improved outcomes in a retrospective analysis of EVAS FORWARD IDE trial 3-year results

ObjectiveAdverse outcomes observed late in the Nellix EndoVascular Aneurysm Sealing (EVAS) System (Endologix, Inc, Irvine, Calif) investigational device exemption trial prompted refinement of the anatomic instructions for use (IFU). This study aimed to investigate the association of procedural factors during Nellix endograft deployment and patient outcomes. MethodsWe retrospectively reviewed 1-month imaging of 333 patients enrolled in the prospective, multicenter EVAS investigational device exemption trial between January 2014 and September 2016. Initial observations of those patients who met revised anatomic IFU yet still experienced late adverse events suggested that inadequate seal and low graft placement were common among these patients. Key procedural variables identified from a univariate analysis were applied to construct four cohorts stratified by procedural technical performance (technically adequate [P+] or technically inadequate [P−]) and the revised anatomic indications for use (anatomically within IFU [A+] or anatomically outside of IFU [A−]) and to compare them for aneurysm-related outcomes. A logistic regression analysis was performed to identify significant predictors of sac expansion or migration. ResultsProximal and distal seal zones and low graft placement were identified by logistic regression analysis as significant predictors of sac expansion or migration. Accordingly, acquisition of ≥10-mm proximal and distal seal zones and the position of the lowest stent within 10 mm of the lowest renal artery were clinically justified as thresholds for a technically adequate procedure. Patients who did not achieve these parameters were deemed to have a technically inadequate procedure. By use of the proposed procedural adequacy criteria and established anatomic criteria, patients were stratified into four cohorts: A+/P+ (n = 77), A+/P− (n = 54), A−/P+ (n = 71), and A−/P− (n = 131). Three-year estimates of freedom from migration of 10 mm were 98.6% in A+/P+, 95.9% in A+/P−, 85.8% in A−/P+, and 80.1% in A−/P−; freedom from type IA endoleak estimates were 98.6% in A+/P+, 100% in A+/P−, 96.4% in A−/ P+, and 90.3% in A−/P− cohorts. Freedom from sac expansion and secondary intervention were 96.9% and 90.6% in A+/P+, 86.0% and 93.6% in A+/P−, 87.1% and 83.1% in A−/P+, and 80.5% and 79.8% in A−/P− groups, respectively. Two early deaths (aneurysm-related mortality) on days 4 and 12 postoperatively were reported within the A+/P− group. Kaplan-Meier estimates of freedom from all-cause mortality and aneurysm-related mortality at 3 years were similar between cohorts. ConclusionsThis post hoc analysis suggests that achieving a 10-mm proximal and distal seal with adequate positioning of the endograft with respect to the renal arteries is associated with improved patient outcomes.

Effectiveness and Safety of a Paclitaxel-Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm: One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of the Eluvia Drug-Eluting Stent

Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy (ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or stent thrombosis had occurred. The Kaplan-Meier estimate of primary patency was 91.0% (95% CI 82.5% to 99.6%). The MAE-free rate at 12 months was 93.5% due to 3 clinically-driven TLRs. The corresponding Kaplan-Meier estimate of freedom from TLR was 93.9% (95% CI 87.2% to 100%). Conclusion: The IMPERIAL Long Lesion substudy demonstrated excellent patency and safety through 1 year among patients with long femoropopliteal occlusive disease treated with the Eluvia stent.

STABLE II clinical trial on endovascular treatment of acute, complicated type B aortic dissection with a composite device design

ObjectiveTo evaluate the safety and effectiveness of a composite device design (covered stent graft and bare metal stent) for the treatment of patients with acute, complicated type B aortic dissection (TBAD) presenting with aortic rupture and/or branch vessel malperfusion. MethodsIn this prospective, nonrandomized, multicenter study, 73 patients (65.8% male; mean age, 60.7 years) with acute, complicated TBAD were enrolled between August 2012 and January 2015 to receive treatment with the Zenith Dissection Endovascular System (William Cook Europe, Aps, Bjaeverskov, Denmark) at institutions in the United States and Japan. The primary safety end point was the rate of freedom from major adverse events at 30 days, and the primary effectiveness end point was the rate of survival at 30 days. This article reports primary outcomes at 30 days and follow-up results through 1 year, reflecting study data as of March 2018. ResultsOf 73 patients, 20 presented with aortic rupture (27%) and 57 presented with branch vessel obstruction/compromise (78%), including 4 patients presenting with both conditions. The covered stent graft was used in all patients (median, 1; range, 1-3; 1 stent graft used in 64.4%; 47/73), and the bare metal dissection stent was used in 58 of 73 patients (79.5%). Thirty-day mortality occurred in five patients (6.8%): one procedure related, three unrelated to dissection repair, and one indeterminate. Thirty-day major adverse events included myocardial infarction (1.4%), bowel ischemia (1.4%), renal insufficiency/renal failure requiring dialysis (6.8%), stroke (6.8%), paraplegia or paraparesis (5.5%), and prolonged ventilatory support (13.7%). Nine deaths occurred from 31 to 365 days (only one death related to dissection repair); the Kaplan-Meier estimate of freedom from all-cause mortality was 80.3% ± 4.7% at 1 year. Within 365 days, 9 of 73 patients (12.3%) underwent 10 secondary interventions; no patients required conversion to open surgery. At the 12-month follow-up, complete or partial thrombosis of the false lumen was seen in 100% of patients (46/46) within the stent graft region and in 97.4% of patients (38/39) within the dissection stent region. Growth (>5 mm) of the maximum transaortic diameter was observed in 14.9% of patients (7/47) in the stent graft region and in 38.5% of patients (15/39) within the dissection stent region at 12 months. ConclusionsThirty-day and 1-year results from the STABLE II study demonstrated favorable clinical and anatomical outcomes for the treatment of rupture and malperfusion in the setting of acute, complicated TBAD. Five-year follow-up is ongoing.