Effects of atherectomy on major adverse limb events for femoropopliteal interventions: Vascular Quality Initiative registry.

BACKGROUND: Atherectomy use in treatment of femoropopliteal disease has significantly increased despite scant evidence of benefit to long-term clinical outcomes. AIMS: We investigated the clinical benefits of atherectomy over standard treatment for femoropopliteal interventions. METHODS: Using data from the Society of Vascular Surgery's Vascular Quality Initiative (VQI) registry, we identified patients who underwent isolated femoropopliteal interventions for occlusive disease. We compared 13,423 patients treated with atherectomy with 47,371 receiving standard treatment; both groups were allowed definitive treatment with a drug-coated balloon or stenting. The primary endpoint was major adverse limb events (MALEs), which is a composite of target vessel re-occlusion, ipsilateral major amputation, and target vessel revascularization. RESULTS: Mean age was 69 ± 11 years, and patients were followed for a median of 30 months. Overall rates of complications were slightly higher in the atherectomy group than the standard treatment group (6.2% vs. 5.9%, p < 0.0001). In multivariable analysis, after adjusting for demographic and clinical covariates, atherectomy use was associated with a 13% reduction in risk of MALEs (adjusted odds ratio [aOR]: 0.87; 95% confidence interval [CI]: 0.77-0.98). Rates of major and minor amputations were significantly lower in the atherectomy group (3.2% vs. 4.6% and 3.3% vs. 4.3%, respectively, both p < 0.001), primarily driven by a significantly decreased risk of major amputations (aOR 0.69; 95% CI: 0.52-0.91). There were no differences in 30-day mortality, primary patency, and target vessel revascularization between the atherectomy and standard treatment groups. CONCLUSIONS: In adults undergoing femoropopliteal interventions, the use of atherectomy was associated with a reduction in MALEs compared with standard treatment.

Effectiveness and Safety of Atherectomy versus Plain Balloon Angioplasty for Limb Salvage in Tibioperoneal Arterial Disease.

PURPOSE: To evaluate the effectiveness and safety of atherectomy versus plain balloon angioplasty (POBA) for treatment of critical limb ischemia (CLI) due to tibioperoneal arterial disease (TPAD). MATERIALS AND METHODS: Patients enrolled in the Vascular Quality Initiative registry who had CLI (Rutherford Class 4-6) and underwent atherectomy versus POBA alone for isolated TPAD were retrospectively identified. Of eligible patients, a cohort of 2,908 patients was propensity matched 1:1 by clinical and angiographic characteristics. The atherectomy group comprised 1,454 patients with 2,183 arteries treated, and the POBA group comprised 1,454 patients with 2,141 arteries treated. The primary study endpoint was major ipsilateral limb amputation. Secondary endpoints were minor ipsilateral amputations, any ipsilateral amputation, primary patency, target vessel reintervention (TVR), and wound healing at 12 months. RESULTS: The median follow-up period was 507 days, the mean patient age was 69 years ± 11.7, and the mean occluded length was 6.9 cm ± 6.5. There was a trend toward higher technical success rates with atherectomy than with POBA (92.9% vs 91.0%, respectively; P = .06). The rates of major adverse events during the procedure were not significantly different. The 12-month major amputation rate was similar in the atherectomy and POBA groups (4.5% vs 4.6%, respectively; P = .92; odds ratio, 0.97; 95% CI, 0.68-1.37). There was no difference in 12-month TVR (17.9% vs 17.8%; P = .97) or primary patency (56.4% vs 54.5%; P = .64) between the atherectomy and POBA groups. CONCLUSIONS: In a large national registry, treatment of CLI from TPAD using atherectomy versus POBA showed no significant differences in procedural adverse events, major amputations, TVR, or vessel patency at 12 months.

Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients.

BACKGROUND: Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients. METHODS: We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods. RESULTS: Of the 1468 patients who underwent randomization, an attempted TAVR or surgical procedure was performed in 1403. The patients' mean age was 74 years. The 24-month estimated incidence of the primary end point was 5.3% in the TAVR group and 6.7% in the surgery group (difference, -1.4 percentage points; 95% Bayesian credible interval for difference, -4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, patients who had undergone TAVR, as compared with surgery, had a lower incidence of disabling stroke (0.5% vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) and a higher incidence of moderate or severe aortic regurgitation (3.5% vs. 0.5%) and pacemaker implantation (17.4% vs. 6.1%). At 12 months, patients in the TAVR group had lower aortic-valve gradients than those in the surgery group (8.6 mm Hg vs. 11.2 mm Hg) and larger effective orifice areas (2.3 cm2 vs. 2.0 cm2). CONCLUSIONS: In patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.).

National trends and variability of atherectomy use for peripheral vascular interventions from 2010 to 2019.

OBJECTIVE: Small, older studies have suggested that the use of atherectomy devices has become common in peripheral vascular interventions (PVIs) despite the paucity of strong clinical guidelines. We analyzed the 10-year trends in the use of atherectomy for PVIs across the United States and identified the main predictors of atherectomy use. METHODS: Using the Vascular Quality Initiative registry, we identified all patients who had undergone endovascular PVIs for occlusive lower extremity arterial disease from 2010 to 2019. Procedures in which an atherectomy device had been used as the primary or secondary device were classified as the atherectomy group. We calculated the frequency of atherectomy use over time and across geographic regions. Using regression modeling, we identified the factors that were independently associated with atherectomy use. RESULTS: A total of 205,377 PVIs had been performed for 152,693 unique patients. During the 10-year period, 16.6% of the PVI procedures had used atherectomy, increasing from 8.5% in 2010 to 19.7% in 2019 (Ptrend < .0001). Across 17 geographic regions, we found a significant difference in the prevalence of atherectomy use, ranging from 8.2% to 29%. The strongest predictor of atherectomy use was performance of PVI in an office setting (odds ratio [OR], 10.08; 95% confidence interval [CI], 9.17-11.09) or ambulatory center (OR, 4.0; 95% CI, 3.65-4.39) vs a hospital setting. The presence of severe (OR, 2.6; 95% CI, 2.4-2.85) or moderate (OR, 1.5; 95% CI, 1.4-1.69) lesion calcification was also predictive of atherectomy use. Other predictive factors included elective status, insurance provider, lesion length, prior PVI, claudication symptoms, and diabetes mellitus. CONCLUSIONS: Atherectomy use in PVI significantly increased from 2010 to 2019. We found wide regional variability in the use of atherectomy that seemed to be driven more strongly by nonclinical factors.

Peripheral Artery Disease Intervention: Drug-Coated Balloon vs Drug-Eluting Stent, A Long-Term Comparison.

Objectives: The aim of the study is to evaluate current trends and long-term durability of both drug-eluting stents (DES) and drug-coated balloons (DCB) in the treatment of peripheral artery disease (PAD). Background: PAD affects more than 200 million people worldwide. Endovascular treatment of critical PAD has advanced in recent years. DES and DCB have demonstrated superiority compared to balloon angioplasty or bare metal stenting. The current literature lacks any long-term, direct comparison. Methods: A retrospective analysis was completed on patients who had femoral-popliteal interventions from June 2014 to June 2018 with either DCB or DES. Patient medical data and lesion characteristics were retrieved using the Vascular Quality Initiative database. Outcomes were analyzed through December 2019. Primary endpoint of time to clinical event-driven target lesion reintervention (TLR) and secondary endpoint of all-cause mortality were examined. Results: Four hundred eighty-three patients with a total of 563 interventions met the inclusion criteria. Three hundred fifty-nine DCB and 204 DES were performed. Of the DCBs, 132 required bailout stenting at the time of procedure. The mean time for TLR in the DES group was 1,277 days (SD 546), compared to 904 days (SD 330.1) for DCB. For patients requiring TLR, DES remained patent significantly longer (373 days longer on average) (p < 0.001). For all-cause mortality there was no significant difference at 50 months between DCB and DES (p = 0.06). Conclusions: In patients who required TLR, DES had a significantly longer length of time to reintervention vs DCB (average 373 days), although no difference in mortality was observed.

Endovascular Treatment of Right Heart Masses Utilizing the AngioVac System: A 6-Year Single-Center Observational Study.

OBJECTIVE: To describe our institution's experience with the AngioVac system. BACKGROUND: Intracardiac and intravascular masses previously required surgical excision, but now, there are a number of minimally invasive options. With the advent of vacuum aspiration, more specifically the AngioVac System (AngioDynamics, NY, USA), there exists a system with both low mortality and minor complications. However, the number of retrospective studies remains limited. Outcome data for high-risk patients are also limited. METHODS: Data were collected and analyzed in patients who underwent AngioVac therapy at our tertiary care center from January 2014 to December 2020. RESULTS: Our results demonstrated a 93.3% intraoperative success rate and a 100% intraoperative survival rate. However, a number of complications, including but not limited to hematomas, anemia, and hypotension, occurred, as described below. CONCLUSIONS: Our experiences demonstrated good outcomes and continue to support the usefulness of the AngioVac System. The data also support the use of AngioVac as a treatment option for the debulking or removal of right heart masses in critically ill patients.

Early clinical and procedural outcomes in large series of 34-mm self-expanding transcatheter aortic valve replacement.

OBJECTIVES: We aimed to evaluate early clinical and procedural outcomes with the 34-mm Evolut R transcatheter aortic valve replacement (TAVR) prosthesis. BACKGROUND: The 34-mm Evolut R (Medtronic, Minneapolis, MN) self-expanding TAVR prosthesis was designed to treat patients with larger annuli. METHODS: Clinical, demographic, procedural, and echocardiographic data on consecutive patients who underwent TAVR with a 34-mm Evolut R prosthesis at our institution were collected and analyzed. RESULTS: One hundred ninety-six patients underwent TAVR with this prosthesis from November 2016 to July 2018, a majority (n = 188, 96%) through transfemoral access and with conscious sedation (n = 182, 93%). Mean age, Society of Thoracic Surgery risk score, and follow-up were 82 ± 8 years, 5.4 ± 5%, and 8.2 ± 5.3 months, respectively. Mean aortic valve (AV) peak velocity was 4.0 ± 0.6 m/s, mean AV gradient was 38 ± 13 mmHg, AV area was 0.79 ± 0.23 cm2 ; calcium score was 3,503 ± 1,970 Agatston units, and perimeter was 85 ± 4.3 mm. Device implantation was successful in all but one patient. Postprocedure mean AV peak velocity, AV mean gradient, and AV area were 1.9 ± 0.4 m/s, 7 ± 3 mmHg, and 2.6 ± 0.7 cm2 , respectively. New pacemaker requirement rate was 16%, and moderate paravalvular leak was present in six patients (3%), which improved to mild in three patients at 6-month follow-up. In-hospital, 30-day, 6-month, and 12-month survival rates were 98%, 96% (hospital discharge), 96% (30-day), 89% (6-month), and 83% (12-month). CONCLUSION: These data demonstrate high success and good procedural, echocardiographic, and clinical outcomes of 34-mm Evolut R in patients with large annuli.

Contemporary practice pattern of revascularization in a large tertiary care referral center in non-ST elevation myocardial infarction: A propensity-matched 10-year experience.

OBJECTIVES: We sought to compare the effects of early versus delayed percutaneous coronary intervention (PCI) on the outcomes at 1 year in patients presenting with non-ST-segment elevation myocardial infarction (NSTEMI). BACKGROUND: Prompt reperfusion in NSTEMI remains controversial. Randomized studies have shown conflicting results regarding the benefits of early intervention versus delayed intervention (defined as intervention performed within 24 hr vs. 24-72 hr of presentation, respectively). This study was conducted to determine the clinical outcomes post PCI in a large tertiary care center. METHODS: A propensity-matched group of 1,640 NSTEMI patients [62.4% males (n = 1,023), median age 65 years] was studied for a composite of death, myocardial infarction (MI), stroke, and heart failure in 1 year as a primary endpoint after PCI. Patients were divided into an early intervention group (EIG) and delayed intervention group (DIG). Timing of PCI was determined by the treating interventional cardiologist. RESULTS: The primary outcome was significantly lower in the EIG than DIG (20.4% vs. 24.9%, P = 0.029), which was mainly derived from mortality benefit in the EIG. There was no difference in occurrence of death, MI, stroke, or heart failure between the groups at 30 days. CONCLUSIONS: An earlier PCI in patients with NSTEMI is associated with a significant reduction in the composite outcome of death, MI, heart failure, or stroke at 1 year compared with delayed PCI. Based on this large cohort of patients from a real-world referral center, contemporary reperfusion practices in NSTEMI may need to be re-examined with a bias toward early intervention.

Effect of Mechanically Expanded vs Self-Expanding Transcatheter Aortic Valve Replacement on Mortality and Major Adverse Clinical Events in High-Risk Patients With Aortic Stenosis: The REPRISE III Randomized Clinical Trial.

Importance: Transcatheter aortic valve replacement (TAVR) is established for selected patients with severe aortic stenosis. However, limitations such as suboptimal deployment, conduction disturbances, and paravalvular leak occur. Objective: To evaluate if a mechanically expanded valve (MEV) is noninferior to an approved self-expanding valve (SEV) in high-risk patients with aortic stenosis undergoing TAVR. Design, Setting, and Participants: The REPRISE III trial was conducted in 912 patients with high or extreme risk and severe, symptomatic aortic stenosis at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015, with final follow-up on March 8, 2017. Interventions: Participants were randomized in a 2:1 ratio to receive either an MEV (n = 607) or an SEV (n = 305). Main Outcomes and Measures: The primary safety end point was the 30-day composite of all-cause mortality, stroke, life-threatening or major bleeding, stage 2/3 acute kidney injury, and major vascular complications tested for noninferiority (margin, 10.5%). The primary effectiveness end point was the 1-year composite of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak tested for noninferiority (margin, 9.5%). If noninferiority criteria were met, the secondary end point of 1-year moderate or greater paravalvular leak was tested for superiority in the full analysis data set. Results: Among 912 randomized patients (mean age, 82.8 [SD, 7.3] years; 463 [51%] women; predicted risk of mortality, 6.8%), 874 (96%) were evaluable at 1 year. The primary safety composite end point at 30 days occurred in 20.3% of MEV patients and 17.2% of SEV patients (difference, 3.1%; Farrington-Manning 97.5% CI, -∞ to 8.3%; P = .003 for noninferiority). At 1 year, the primary effectiveness composite end point occurred in 15.4% with the MEV and 25.5% with the SEV (difference, -10.1%; Farrington-Manning 97.5% CI, -∞ to -4.4%; P<.001 for noninferiority). The 1-year rates of moderate or severe paravalvular leak were 0.9% for the MEV and 6.8% for the SEV (difference, -6.1%; 95% CI, -9.6% to -2.6%; P < .001). The superiority analysis for primary effectiveness was statistically significant (difference, -10.2%; 95% CI, -16.3% to -4.0%; P < .001). The MEV had higher rates of new pacemaker implants (35.5% vs 19.6%; P < .001) and valve thrombosis (1.5% vs 0%) but lower rates of repeat procedures (0.2% vs 2.0%), valve-in-valve deployments (0% vs 3.7%), and valve malpositioning (0% vs 2.7%). Conclusions and Relevance: Among high-risk patients with aortic stenosis, use of the MEV compared with the SEV did not result in inferior outcomes for the primary safety end point or the primary effectiveness end point. These findings suggest that the MEV may be a useful addition for TAVR in high-risk patients. Trial Registration: ClinicalTrials.gov Identifier: NCT02202434.

Bivalirudin versus unfractionated heparin during peripheral vascular interventions: A Propensity-matched Study.

OBJECTIVES: This study aimed to compare the association of access site complications and the use of unfractionated heparin versus bivalirudin during subinguinal peripheral vascular intervention. BACKGROUND: Compared to unfractionated heparin, bivalirudin has been associated with fewer bleeding complications in patients undergoing percutaneous coronary intervention but more ischemic events. The safety and efficacy of direct thrombin inhibitors in peripheral vascular interventions is not well defined. METHODS: We compared the incidence of in-hospital access site complications and discharge status among patients in the multicenter, prospective Vascular Quality Initiative registry who underwent peripheral vascular intervention between August 2007 and January 2014 using bivalirudin or unfractionated heparin. Propensity score matching was used to obtain a balanced cohort of 1,524 patients in each treatment group. RESULTS: Patients treated with bivalirudin had a significantly lower incidence of access site hematomas (2.4% vs. 3.9%, P = 0.018), shorter post-procedural hospitalization (1.0 vs. 1.2 days, P < 0.001) and lower rates of discharge to a nursing home or rehabilitation center rather than home (7.61% vs. 9.73%, P = 0.034) when compared with unfractionated heparin-treated patients. The incidence of in-hospital access site occlusion, distal embolization, and mortality did not differ significantly between groups. CONCLUSIONS: Patients who received bivalirudin had lower rates of access site hematoma, shorter length of stay, and improved discharge status compared with unfractionated heparin during hospitalization for peripheral vascular intervention. Randomized comparisons of these agents are needed to confirm these findings. © 2016 Wiley Periodicals, Inc.

Intentional Oversizing of Valve in Transcatheter Aortic Valve Replacement: Is Bigger Better? A Large, Single-Center Experience.

Background: The current clinical practice standard is 10% to 20% oversizing of self-expanding valves in transcatheter aortic valve replacement. We aimed to determine whether >20% oversizing of self-expanding valves (Medtronic Evolut) would lead to better valve performance with similar or better outcomes. Methods: From October 2011 to December 2016, we approached all transcatheter aortic valve replacement patients with a conscious attempt at large oversizing (>20%). The most common valve used, excluding those used in valve-in-valve patients, was the 29-mm Evolut R (29%). We used a retrospective chart review to compare moderate oversizing (group 1; 10% to 20%) with large oversizing (group 2; >20%). Results: Of 556 patients, 45% were male; the overall mean Society of Thoracic Surgeons risk score was 5.8 ± 3.8. Eighty-five (15%) patients needed a pacemaker, and 21 (3.8%) developed significant paravalvular leak. Mean oversizing was 20.3% ± 6.0%, with 41.4% of patients included in group 1 and 54.5% in group 2. Incidences of complications in group 2 vs. group 1 were as follows: a) paravalvular leak (2.0 vs. 6.1%; odds ratio = 0.31, p = 0.01), b) pacemaker (15 vs. 14%), c) gastrointestinal bleed (n = 4 vs. 0; 1.3 vs. 0.0%; p = 0.03), d) annular dissection (n = 1 vs. 0; 0.3 vs. 0%; p = 0.29), e) mortality (n = 5 vs. 4; 1.6 vs. 1.7%). Incidence of paravalvular leak was higher in those who died than survivors (13 vs. 1.3%; p ≤ 0.0001). Conclusions: These data suggest that, in current self-expanding valves, >20% oversizing delivers a significantly lower prevalence of paravalvular leak without an increase in other complications. Since paravalvular leak is associated with increased mortality, >20% oversizing may represent a superior prosthesis choice.

2-Year Clinical and Echocardiography Follow-Up of Transcatheter Mitral Valve Replacement With the Transapical Intrepid System.

BACKGROUND: Thirty-day outcomes with the investigational Intrepid transapical (TA) transcatheter mitral valve replacement (TMVR) system have previously demonstrated good technical success, but longer-term outcomes in larger cohorts need to be evaluated. OBJECTIVES: The authors sought to evaluate the 2-year safety and performance of the Intrepid TA-TMVR system in patients with symptomatic, ≥moderate-severe mitral regurgitation (MR) and high surgical risk. METHODS: Patient eligibility was determined by local heart teams and approved by a central screening committee. Clinical events were adjudicated by an independent clinical events committee. Echocardiography was evaluated by an independent core laboratory. RESULTS: The cohort included 252 patients that were enrolled at 58 international sites before February 2021 as part of the global Pilot Study (n = 95) or APOLLO trial (primary cohort noneligible + TA roll-ins, n = 157). Mean age was 74.2 years, mean STS-PROM was 6.3%, 60.3% were male, and 80.6% were in NYHA functional class III/IV. Most presented with secondary MR (70.1%), and nearly all had ≥moderate-severe MR (98.4%). All-cause mortality was 13.1% (30-day), 27.3% (1-year), and 36.2% (2-year). The 30-day ≥major bleeding event rate was 22.3%. Heart failure rehospitalization was 9.6% (30-day) and 36.2% (2-year). At 2 years, >50% of patients were alive with improvement in NYHA functional class (82.1%, class I/II), and all patients with available echocardiograms had ≤mild MR. CONCLUSIONS: This analysis represents the largest reported TA-TMVR experience with the longest follow-up in high-risk ≥moderate-severe MR patients. Early mortality and heart failure rehospitalizations were significant, exacerbated by early TA-related bleeding events; however, meaningful improvements in clinical outcomes and marked reductions in MR severity were observed through 2 years.

Five-Year Follow-Up from the CoreValve Expanded Use Transcatheter Aortic Valve-in-Surgical Aortic Valve Study.

Transcatheter aortic valve replacement (TAVR) provides an option for extreme-risk patients who underwent reoperation for a failed surgical aortic bioprosthesis. Long-term data on patients who underwent TAVR within a failed surgical aortic valve (TAV-in-SAV) are limited. The CoreValve Expanded Use Study evaluated patients at extreme surgical risk who underwent TAV-in-SAV. Outcomes at 5 years were analyzed by SAV failure mode (stenosis, regurgitation, or combined). Echocardiographic outcomes are site-reported. TAV-in-SAV was attempted in 226 patients with a mean age of 76.7 ± 10.8 years; 63.3% were male, the Society of Thoracic Surgeons predicted risk of mortality score was 9.0 ± 6.7%, and 87.5% had a New York Heart Association classification III or IV symptoms. Most of the failed surgical bioprostheses were stented (81.9%), with an average implant duration of 10.2 ± 4.3 years. The 5-year all-cause mortality or major stroke rate was 47.2% in all patients; 54.4% in the stenosis, 37.6% in the regurgitation, and 38.0% in the combined groups (p = 0.046). At 5 years, all-cause mortality was higher in patients with versus without 30-day severe prosthesis-patient mismatch (51.7% vs 38.3%, p = 0.026). The overall aortic valve reintervention rate was 5.9%; highest in the regurgitation group (12.6%). The mean aortic valve gradient was 14.1 ± 9.8 mm Hg and effective orifice area was 1.57 ± 0.70 at 5 years. Few patients had >mild paravalvular regurgitation at 5 years (5.5% moderate, 0.0% severe). TAV-in-SAV with supra-annular, self-expanding TAVR continues to represent a safe and lasting intermediate option for extreme-risk patients who have appropriate sizing of the preexisting failed surgical valve. Clinical and hemodynamic outcomes were stable through 5 years.

Use and performance of the evolut FX transcatheter aortic valve system.

BACKGROUND: The next generation supra-annular, self-expanding Evolut FX transcatheter aortic valve (TAV) system was designed to improve catheter deliverability, provide stable and symmetric valve deployment, and assess commissural alignment during the procedure. The impact of these modifications has not been clinically evaluated. METHODS: Procedural information was collected by survey in 2 Stages: Stage I comprised 23 centers with extensive experience with Evolut TAV systems, and Stage II comprised an additional 46 centers with a broad range of balloon- and self-expanding system experience. Operators were to compare the experience with the Evolut FX to the predicate Evolut PRO+ system. RESULTS: There were 285 cases during Stage I from June 24 to August 12, 2022, and 254 cases during Stage II from August 15 to September 11, 2022. Overall, the cusp overlap technique was used in 88.6 %, and commissural alignment was achieved in 96.1 % of these cases. Compared to implanter's previous experience with the Evolut PRO+ system, less resistance was noted with the Evolut FX system: in 83.0 % of cases during vascular insertion, in 84.7 % of cases while tracking through the vasculature, in 84.4 % of cases while traversing over the arch, and 76.1 % of cases in advancing across the valve. Better symmetry of valve depth was observed in 423 of 525 cases (80.6 %). CONCLUSION: Evolut FX system design modifications translated into improvements in catheter deliverability, deployment symmetry and stability, and commissural alignment as assessed by experienced self-expanding and balloon expandable operators.

Subintimal angioplasty with a true reentry device for treatment of chronic total occlusion of the arteries of the lower extremity.

OBJECTIVE: To report the efficacy and safety of the Outback(®) LTD(®) Re-Entry Catheter in reentering the distal true lumen during percutaneous intentional extraluminal revascularization (PIER). BACKGROUND: Reentry catheters are used to treat chronic, total arterial occlusions of the lower extremities when standard methods of recanalization have failed. Success and complication rates of these catheters in the real world are uncertain and variable. METHODS: A retrospective review of our peripheral catheterization database from January 2004 to September 2009 was undertaken to identify consecutive cases of peripheral chronic total occlusions (CTOs) requiring the use of the Outback reentry catheter. Patient demographics, indication for the procedure, location and extent of occlusion, procedural success, and complications were studied. RESULTS: A total of 51 patients were identified. Of the 51, 28 (54.9%) patients presented with nonhealing ulcer and 22 (43.1%) had lifestyle-limiting claudication. One patient presented with acute limb ischemia. There were 6 (11.8%) patients with common iliac artery occlusion, 2 (3.9%) with external iliac artery occlusion, 1 (1.9%) with common femoral artery occlusion, 35 (68.6%) with superficial femoral artery occlusion, 6 (11.8%) with popliteal artery occlusion, and 1 (1.9%) with tibioperoneal artery occlusion. Median lesion length was 230 mm. Procedural success was achieved in 49 patients (96.1%). There was 1 (1.9%) periprocedural complication. CONCLUSION: Use of Outback(®) LTD(®) Re-Entry Catheter is a safe and valuable option for PIER/subintimal angioplasty and recanalization in patients with symptomatic lower-extremity CTOs. However, long-term patency remains unknown.

Heparin-bonded, expanded polytetrafluoroethylene-lined stent graft in the treatment of femoropopliteal artery disease: 1-year results of the VIPER (Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease) trial.

PURPOSE: To evaluate the performance of a heparin-bonded, expanded polytetrafluoroethylene (ePTFE)-lined nitinol endoprosthesis in the treatment of long-segment occlusive disease of the femoropopliteal artery (FPA) and to identify factors associated with loss of patency. MATERIALS AND METHODS: In a single-arm, prospective, 11-center study (VIPER [Gore Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease] trial), 119 limbs (113 patients; 69 men; mean age, 67 y), including 88 with Rutherford category 3-5 disease and 72 with Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) C or D lesions of the FPA, underwent stent graft implantation. The mean lesion length was 19 cm; 56% of lesions were occlusions. Follow-up evaluations included color duplex ultrasonography in all patients, with patency defined as a peak systolic velocity ratio< 2.5. RESULTS: At 12 months, Rutherford category and ankle-brachial index (ABI) were significantly improved (mean category improvement, 2.4; ABI increased from 0.6±0.2 to 0.9±0.19; P<.0001). Primary and secondary patency rates were 73% and 92%. The primary patency for devices oversized<20% at the proximal landing zone was 88%, whereas the primary patency for devices oversized by>20% was 70% (P = .047). Primary patency was not significantly affected by device diameter (5 vs 6 vs 7 mm) or lesion length (≤20 cm vs>20 cm). The 30-day major adverse event rate was 0.8%. CONCLUSIONS: The heparin-bonded, ePTFE/nitinol stent graft provided clinical improvement and a primary patency rate of 73% at 1 year in the treatment of long-segment FPA disease. Careful sizing of the device relative to vessel landing zones is essential for achieving optimal outcomes.

Left subclavian artery pseudoaneurysm after blunt chest trauma with left upper extremity ischemia.

We describe a 74-year-old male with delayed onset of acute left upper extremity ischemia after blunt chest trauma with left clavicular fracture, resulting in left subclavian artery injury, including pseudoaneurysm formation, intramural hematoma, thrombosis, and distal embolization to the brachial artery. The patient presented with left upper extremity pain, forearm and hand numbness, and digital cyanosis. The patient was treated with a hybrid approach, consisting of transfemoral percutaneous deployment of a covered stent in the left subclavian artery and concomitant surgical thrombectomy of the left brachial artery, resulting in excellent recovery and resolution of symptoms.

Sex Disparities in Diagnostic Evaluation and Revascularization in Patients With Acute Myocardial Infarction-A 15-Year Nationwide Study.

Background Although sex disparities in the diagnostic evaluation and revascularization of patients with acute myocardial infarction are well documented, no study has evaluated longitudinal trends in these disparities. Methods and Results Using the National Inpatient Sample from 2005 to 2019, 9 259 932 patients with acute myocardial infarction were identified. We divided 15 years into five 3-year periods. The primary objective was to evaluate sex-based trends in the use of diagnostic angiography, percutaneous coronary intervention, and coronary artery bypass graft (CABG) among patients with non-ST-segment-elevation myocardial infarction and ST-segment-elevation myocardial infarction (STEMI) over 15 years. The secondary objective was to evaluate sex disparities in mortality, length of stay, and cost. For non-ST-segment-elevation myocardial infarction, we saw a small reduction in sex disparity in the use of all diagnostic angiography in period 5 versus period 1 (4% versus 5.3%; P<0.01), no change in sex disparity in percutaneous coronary intervention use in period 5 versus period 1 (5.6% versus 5%; P=0.16), and a widening sex disparity in CABG in period 5 versus period 1 (5.4% versus 4.4%; P<0.01). However, we noted decreasing sex disparities in the use of diagnostic angiography, percutaneous coronary intervention, and CABG for ST-segment-elevation myocardial infarction in mostly all periods compared with period 1 (P<0.05, all comparisons), but differences still existed in period 5. Risk-adjusted in-hospital mortality was higher after CABG for non-ST-segment-elevation myocardial infarction and after percutaneous coronary intervention and CABG for ST-segment-elevation myocardial infarction in women than men. Conclusions Despite variable trends in sex disparities in diagnostic and revascularization procedures for acute myocardial infarction, disparities still exist.

Age-Based Trends in the Outcomes of Percutaneous Left Atrial Appendage Occlusion: Insights from a Real-World Database.

The age-based trends in-hospital outcomes in patients with percutaneous left atrial appendage occlusion (LAAO) are unknown. Using the National Readmission Database from 2016 to 2019, patients who underwent LAAO were divided into 2 age groups: 60 to 79 and ≥80 years. The primary objective was to evaluate the age-based trends in the outcomes related to LAAO. The secondary objectives were to evaluate the mean cost and total cumulative cost of readmissions in both age groups in 2019. We identified 58,818 patients who underwent LAAO, of whom 36,964 (63%) were aged 60 to 79 years, and 21,854 (37%) were ≥80 years. The hospital mortality, pericardial complications, acute kidney injury, and in-hospital cardiac arrest did not change over time. The risk-adjusted postoperative stroke and bleeding requiring blood transfusion decreased in patients aged ≥80 years (p trend 0.03 for both outcomes). The length of stay decreased, and early discharge rates increased over time in both the unadjusted and risk-adjusted models in both age groups. The risk-adjusted 90-day readmission rates also decreased in patients aged ≥80 years. The inflation-adjusted cost did not change over time on the unadjusted and adjusted analyses. The total cumulative all-cause 90-readmission cost for both groups in 2019 was $31.7 million. Most outcomes after LAAO either improved or did not change from 2016 to 2019. Hospital mortality has remained <0.5% consistently since 2016. The risk-adjusted postoperative stroke, bleeding, and 90-day readmission rates improved in elderly vulnerable patients aged ≥80 years. The inflation-adjusted cost did not improve despite the decreasing length of stay and improving early discharge rates.

Early Thoracic Endovascular Aortic Repair of Uncomplicated Type B Thoracic Aortic Dissection: An Aorta Team Approach.

BACKGROUND: Although uncomplicated Type B aortic dissection (uTBAD) is traditionally treated with optimal medical therapy (OMT) as per guidelines, recent studies, performed primarily in interventional radiology or surgical operating rooms, suggest superiority of thoracic endovascular aortic repair (TEVAR) over OMT due to recent advancements in endovascular technologies. We report a large, single-center, case control study of TEVAR versus OMT in this population, undertaken solely in a cardiac catheterization laboratory (CCL) with a cardiologist and surgeon. We aimed to determine if TEVAR for uTBAD results in better outcomes compared with OMT. METHODS: This was a retrospective chart review of all patients with uTBAD during the last 13 years, with 46 cases (TEVAR group) and 56 controls (OMT group). RESULTS: In the TEVAR group, the procedure duration of 2.5 hours resulted in 100% procedural success for stent placement, with 63% undergoing protective left subclavian artery bypass, 0% mortality or stroke, and a lower readmission rate (1 vs. 2%; p = 0.04 in early TEVAR cases), but a longer length of stay (12.9 vs. 8.5 days: p = 0.006). The risk of all-cause long-term mortality was markedly reduced in the TEVAR group (RR = 0.38; p = 0.01), irrespective of early (<14 days) versus late intervention. On follow-up computed tomography imaging, the false lumen stabilized or decreased in 85% of cases, irrespective of intervention timing. CONCLUSION: TEVAR performed solely in the CCL is safe and effective, with lower all-cause mortality than OMT. These data, in collaboration with previous data on TEVAR in different settings, call for consideration of an update of practice guidelines.