Shannon D. Thomas

Incidence and prognosis of vascular complications after transcatheter aortic valve implantation.

OBJECTIVE Transcatheter aortic valve implantation (TAVI) has gained increasing global popularity as a minimally invasive option for high-risk cardiac patients. However, this operation is not without risk, particularly of significant vascular complications that increase the morbidity, mortality, and overall cost of the procedure. We aim to present our experience of TAVI-related vascular complications, including the morbidity and cost impacts of these events. METHODS A case-series study was performed for all patients undergoing TAVI at our center. Vascular complications were defined according to the 2011 Valve Academic Research Consortium standardized end points. The data were prospectively collected from February 2009 to April 2012, and the outcomes were entered into a database and cross-checked with the hospital notes. RESULTS TAVI was performed on 100 patients in our center during the study period, and the 30-day mortality was 6%. Access approaches included 81 transfemoral, 18 transapical, and one trans-subclavian access. The average patient age was 84.9 years, and 65% of the patients were male. Among the transfemoral procedures, there were 16 vascular access-related complications (VAC), including nine major and seven minor complications. The major complications included aortic dissection, iliac arterial rupture, femoral dissection, false aneurysms, and distal embolization, all of which required surgical or endovascular repair. An apical false aneurysm and an apical tear were major VAC of the transapical group, with the latter resulting in death. Patients with VAC had higher blood transfusion requirements (4.1 ± 4.5 units vs 0.9 ± 2.2 units; P = .004), greater length of hospital stay (16.4 ± 10.7 days vs 6.5 ± 5.1 days; P = .001), and increased cost (A

Initial Experience With the Absorb Bioresorbable Vascular Scaffold Below the Knee: Six-Month Clinical and Imaging Outcomes

93,448 ± 21,435 vs A

An Endovascular-First Approach to the Treatment of Critical Limb Ischemia Results in Superior Limb Salvage Rates:

69,932 ± 15,007; P = .002) compared with the non-VAC group. The predictors of vascular complications using multivariate analysis included European System for Cardiac Operative Risk Evaluation (odds ratio, 1.06; 95% confidence interval, 1.02-1.10; P = .001) and diabetes mellitus (odds ratio, 5.07; 95% confidence interval, 1.17-21.88; P = .03). Occurrence of major VAC did not affect in-hospital or 30-day mortality rates and was not associated with poorer survival. CONCLUSIONS Vascular complications affect perioperative management and outcomes following TAVI. Our findings show that these complications often require urgent surgical or endovascular repair and result in increased blood transfusions, greater length of hospital stay, and significantly increased costs. Diabetes mellitus and logistic European System for Cardiac Operative Risk Evaluation may be predictive of VAC and should be considered during TAVI patient selection.

Experience With the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Arteries Below the Knee: 12-Month Clinical and Imaging Outcomes.

Purpose: To investigate a new bioresorbable vascular scaffold for the treatment of focal tibial and distal popliteal lesions. Methods: Tibial and distal popliteal angioplasty was performed in 15 limbs of 14 patients (9 men; median age 82 years) with critical limb ischemia (CLI, n=7) or severe claudication. The 18 lesions (mean length 22.2±14.0 mm) were implanted with 22 everolimus-eluting bioresorbable scaffolds (Absorb). Clinical and ultrasound follow-up was performed at 1, 3, 6, and 12 months to detect restenosis and evaluate safety, midterm restenosis rate, and clinical improvement. Results: Immediate technical success was 100%, although a single limb suffered 2 scaffold thromboses on the first day; it was salvaged with repeat endovascular intervention. All patients were available for surveillance examinations during a follow-up of 6.1±3.9 months; no patient died. Of the 15 limbs in the analysis, clinical improvement was present in 12 (4 of 7 CLI patients); there was no amputation, bypass surgery, or evidence of binary restenosis on follow-up sonographic examination. Conclusion: Midterm follow-up for this small pilot sample demonstrates acceptable safety and patency results, together with freedom from all major adverse limb events, using the Absorb bioresorbable vascular scaffold below the knee.

Vasculitis resulting from a superficial femoral artery angioplasty with a paclitaxel-eluting balloon

Purpose: To evaluate the effect of a shift to a primary endovascular revascularization (ER) strategy for patients presenting with critical limb ischemia (CLI) after a change in staff at our center in 2008 altered our revascularization strategy. Methods: Between 2004 and 2012, 344 critically ischemic limbs were treated in 279 patients (mean age 74.0±11.4 years; 179 men) during 546 separate hospital admissions. Limbs were analyzed according to (1) their principal revascularization strategy and (2) their date of presentation [early (2004–2008) or late (2008–2012)]. Results: Compared with the open revascularization (OR) and no revascularization (NR) groups, the ER group had an increased freedom from major amputation (92.3% vs 80.0% OR vs 69.3% NR, p<0.001), reduced hospital stay (15.2 vs OR 31.6 vs NR 25.9 days, p<0.001), intensive care unit (ICU) stay (2.3 vs OR 23.7 vs NR 7.2 hours, p=0.033), and operating time for ER vs OR (157.9 vs 316.8 minutes, respectively; p<0.0001). There was also a significant decrease in limbs requiring minor amputations (23.2% vs OR 29.3% vs NR 37.6%, p=0.041) and mean number of admissions/limb compared to OR (1.5 vs OR 1.9 vs NR 1.5, p=0.007). The late era saw the treatment of a larger number of limbs (223 vs 121) compared with the earlier time period. This institutional shift resulted in increased freedom from major amputation (87.4% vs 74.4%, p<0.01), reduced ICU stay (3.45 vs 16.98 hours, p<0.01), and shorter length of stay (20.9 vs 31.5 days, p<0.01) between the 2 eras, respectively. Conclusion: A shift to an endovascular-first treatment strategy is associated with fewer major amputations and shorter length of stay.

A Real-World Experience With the Supera Interwoven Nitinol Stent in Femoropopliteal Arteries: Midterm Patency Results and Failure Analysis.

OBJECTIVES The aim of this study was to investigate the midterm performance of an everolimus-eluting, bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, California) for the treatment of focal tibial and distal popliteal lesions. BACKGROUND Drug-eluting stents are used below the knee to improve technical success and durability, but the ongoing presence of a permanent metal scaffold may have deleterious effects on the local vessel. METHODS Tibial and distal popliteal angioplasty with scaffold placement was performed using an everolimus-eluting, bioresorbable scaffold (Absorb). Clinical and ultrasound follow-up was performed at 1, 3, 6, 12, and 24 months to detect binary restenosis and evaluate safety, restenosis, and clinical improvement. RESULTS Thirty-eight limbs in 33 patients were treated for critical limb ischemia (68.4%) or severe claudication (31.6%). Fifty scaffolds were used to treat a total of 43 lesions, with a mean length of 19.2 ± 11.6 mm. During a mean follow-up period of 12.0 ± 3.9 months, 5 patients died, and all others were available for follow-up. Among the 38 treated limbs, clinical improvement was present in 30 (79%). Binary restenosis was detected in 3 of 50 scaffolds (6%). Using the Kaplan-Meier method, rates of primary patency were 96% and 84.6% at 12 and 24 months, respectively, and rates of freedom from clinically driven target lesion revascularization were 96% and 96% at 12 and 24 months, respectively. Complete wound healing occurred in 64% of those treated for tissue loss, with no major amputation and a limb-salvage rate of 100%. CONCLUSIONS Twelve-month follow-up demonstrated excellent safety, patency, and freedom from target lesion revascularization using the Absorb bioresorbable vascular scaffold below the knee.

A comprehensive renal vascular access clinic results in improved patient outcomes and reduced costs

Drug-eluting balloons (DEBs) coated with the antiproliferative agent paclitaxel may improve primary patency by reducing recurrent luminal stenosis. A proportion of the active drug and excipient coating are known to embolize distally, but until now, there have been no reports of adverse events resulting from their use. We report an unusual case of a painful nodular, biopsy specimen-proven vasculitic rash that afflicted the ipsilateral lower limb of a patient after superficial femoral artery treatment with a DEB. This adverse event may have implications for the use of DEB in this and other vascular territories.

Lessons Learned Regarding Handling and Deployment of the Absorb Bioresorbable Vascular Scaffold in Infrapopliteal Arteries

Purpose: To evaluate the safety and midterm patency of the Supera interwoven nitinol stent in a real-world population and determine deployment and patient-related factors that may predispose to loss of patency. Methods: A retrospective analysis was conducted of 111 consecutive limbs from 97 patients (mean age 75.3 years; 68 men) with severe atherosclerotic disease of the superficial femoral and popliteal arteries that were treated with Supera stents between June 2012 and October 2014. Half the patients had claudication (56%); the remainder had rest pain (19%) and tissue loss (26%). Forty-eight (43%) lesions were chronic total occlusions, and more than half were classified as TransAtlantic Inter-Society Consensus C (22%) or D (30%). Results: All 146 Supera stents (1.32 stents per limb) were deployed successfully, extending over a mean length of 175.5±130.5 mm to treat lesions averaging 151.5±127.1 mm long. At 30 days, Kaplan-Meier estimated freedom from death, target lesion revascularization, and amputation was 97.3%. Primary patency and freedom from clinically driven target lesion revascularization rates were 87.1% and 95.0% at 6 months, respectively, and 78.9% and 87.6% at 12 months, respectively. Four distinct mechanisms for failure were identified in the 13 limbs in which patency was lost; stent intussusception (n=4), compromised inflow or outflow (n=2), gross oversizing (n=1), and neoplastic thrombophilia (n=1); the cause of 5 occlusions could not be identified. Conclusion: In this heterogeneous group that included long and complex atheromatous femoropopliteal lesions, the Supera stent achieved excellent clinical and patency results at 1 year. Further improvement may be achieved through careful patient selection and the avoidance of deployment pitfalls.

Endovascular Repair of Abdominal Aortic Aneurysms With Reverse Taper Neck Anatomy Using the Endurant Stent-Graft: Analysis of Stent-Graft Oversizing

Management of vascular access for haemodialysis is a leading cause of morbidity and hospitalization in patients with end‐stage renal disease. We sought to evaluate the change in admission and procedural outcomes before and after the establishment of a vascular surgeon‐led comprehensive renal vascular access clinic (RVAC).

Cost Analysis of Initial Treatment With Endovascular Revascularization, Open Surgery, or Primary Major Amputation in Patients With Peripheral Artery Disease:

Purpose: To describe relevant technical details with which to facilitate safe and effective use of the Absorb coronary bioresorbable vascular scaffold (BVS) in lower extremity arteries. Technique: The Absorb BVS is a balloon-expandable, poly-l-lactide structure covered in a poly-d,l-lactide bioresorbable polymer that contains the antiproliferative drug everolimus. As a polymeric structure, it has a number of unique physical, handling, and imaging properties that may differ from metallic stents and pose a challenge to the interventionist. Attention must be paid to lesion selection, preparation, scaffold sizing, deployment, and postdilation to achieve optimal outcomes. A detailed description of these issues and deployment techniques is offered based on experience using this BVS in below-the-knee arteries. Conclusion: The Absorb BVS may have application in the infrapopliteal circulation; however, its unique properties warrant careful consideration before use in the lower limb.