Non-Dissecting Distal Aortic and Peripheral Arterial Aneurysms in Patients With Marfan Syndrome.

Background: In Marfan syndrome (MFS), an aortic or peripheral arterial dilatation is usually the consequence of aortic dissection. Non-dissecting distal aortic and peripheral aneurysms (DAPA) are barely described. We sought to determine the incidence and prognostic impact of non-dissecting DAPA, requiring a surgical repair in a large population of patients with MFS. Methods: The patients referred to the French MFS reference center were included in a prospective database, and the patients treated for a non-dissecting DAPA between 2013 and 2020 were retrospectively reviewed. The first-line therapy was open surgery. The patients unfit for open repair or experiencing life-threatening complications underwent endovascular repair. Results: Among 1,575 patients with MFS, 19 (1.2%) were operated for 25 non-dissecting DAPA. The mean age was 42.4 ± 11.5 years. Non-dissecting DAPA involved the subclavian or axillary artery (n = 12), the descending or thoracoabdominal aorta (n = 6), the abdominal aorta andiliac arteries (n = 6), and the popliteal artery (n = 1). Open and endovascular repairs were performed in 22 and three cases, respectively. After a median follow-up of 54.2 months, no local recurrence was noticed and no secondary procedure was performed. Eight patients presented a new aortic event, including two aortic dissections and seven new aortic surgeries. Compared to the overall MFS population, the non-dissecting DAPA group presented a significantly higher risk of an aortic event (100 vs. 28%, p < 0.0001), a higher risk of aortic dissection (53 vs. 8%, p < 0.0001), and a higher rate of pejorative genetic mutations (68 vs. 40%, p = 0.011). Conclusion: Among the patients with MFS, the diagnosis of non-dissecting DAPA is infrequent but is associated with a significant adverse outcome, thus, advocating for a specific follow-up.

Staged hybrid repair of type II thoracoabdominal aneurysms.

BACKGROUND: Open repair of type II thoracoabdominal aortic aneurysms (TAAAs) remains a challenging procedure. Staged procedures could decrease the incidence and severity of complications after complex aortic repair. In the present report, we have described a strategy using thoracic endovascular aortic repair (TEVAR) for proximal repair, followed by distal open repair. METHODS: From 2014 to 2018, 14 patients had undergone TEVAR, followed by distal open repair, for type II TAAAs. All patients should have a suitable proximal landing zone according to the current guidelines. In cases of chronic dissection, false lumen embolization was performed to achieve total exclusion. RESULTS: The mean patient age was 48 ± 15 years. Of the 14 patients, 5 had had Marfan syndrome (36%) and 6 had undergone previous aortic arch repair (43%). Ten patients had had a chronic dissection. The maximal aortic diameter was 73 ± 12 mm. The TEVAR technical success rate was 100%. The aortic length coverage was 211 ± 63 mm. The number of covered segmental arteries was 6 (range, 4-13). Two endoleaks were observed, one type Ib and one type II. The delay between TEVAR and open repair was 12 ± 8 weeks. Cerebrospinal fluid drainage was used in 13 patients. Six patients had undergone segmental artery reattachment during surgery. No spinal cord ischemic event was observed. One patient had died 5 weeks after open repair of multiple organ failure. During the 32 months of follow-up, no aortic-related deaths had occurred. No new aortic procedure was needed. The type Ib endoleak had resolved during open repair, and the type II TAAA had resolved spontaneously. The mean maximal thoracic aortic diameter had significantly decreased to 49 ± 8 mm (P < .0001). Aneurysmal shrinkage of ≥5 mm was observed in 13 patients (93%). CONCLUSIONS: Staged hybrid repair of type II TAAAs appears to be efficient, with low morbidity and mortality rates. This technique could improve postoperative outcomes after open repair, and TEVAR might have a role in ischemic preconditioning to protect against spinal cord ischemia.

An Experimental Study of Paclitaxel Embolisation During Drug Coated Balloon Angioplasty.

OBJECTIVE: Drug coated balloons (DCB) improve the patency of femoropopliteal angioplasty but their use in infrapopliteal lesions is debateable as paclitaxel (PTX) particle embolisation has been suspected in some trials. The aim of this study was to compare experimentally five DCBs in terms of distal embolism of PTX. METHODS: Twenty-five New Zealand rabbits were divided into five groups according to the DCB used: Lutonix (Bard), In.Pact (Medtronic), Passeo-18 Lux (Biotronik), Ranger (Boston Scientific), and Stellarex (Spectranetics) (n = 5 in each group). After ligation of the right common iliac artery, a 4 × 40 mm DCB was inflated in the infrarenal aorta for 180 seconds. Rabbits were euthanised two hours after inflation of the DCB. The infrarenal aorta, a blood sample and three left hind leg muscles (tensor fasciae latae [TFL], vastus lateralis [VL], and tibialis anterior [TA] muscles) were harvested for blind measurement of PTX concentrations and histological analysis (PTX emboli count). RESULTS: In the TA muscle (the most distal), concentrations of PTX were significantly lower for the Ranger (0.067 ng/mg) than for the Lutonix (0.342 ng/mg; p = .008), In.Pact (0.370 ng/mg; p = .012), and Passeo-18-Lux (0.160 ng/mg; p = .021) DCBs. Similarly, concentrations of PTX were significantly lower for the Passeo-18-Lux than for the In.Pact (p = .028). Concentrations of PTX were not significantly different between DCBs in the TFL and VL muscles. Concentrations of PTX were found to be significantly higher in the plasma and lower in the aorta and on the DCBs after use of Lutonix compared with the four other DCBs. Histological analysis revealed evidence of embolised PTX crystals in small arterioles of all muscle tissue samples without any significant difference between the DCBs. CONCLUSIONS: This study suggests some differences regarding distal embolisation profiles between the five assessed DCBs. Although clinical implications remain to be demonstrated, the present results may have implications when choosing a DCB, especially in a critical limb ischaemia setting.

Peroneal bypass versus endovascular peroneal intervention for critical limb ischemia.

OBJECTIVE: The peroneal artery is a well-established target for bypass in patients with critical limb ischemia (CLI). The objective of this study was to evaluate the outcomes of peroneal artery revascularization in terms of wound healing and limb salvage in patients with CLI. METHODS: Patients presenting between 2006 and 2013 with CLI (Rutherford 4-6) and isolated peroneal runoff were included in the study. They were divided into patients who underwent bypass to the peroneal artery and those who underwent endovascular peroneal artery intervention. Demographics, comorbidities, and follow-up data were recorded. Wounds were classified by Wound, Ischemia, foot Infection (WIfI) score. The primary outcome was wound healing; secondary outcomes included mortality, major amputation, and patency. RESULTS: There were 200 limbs with peroneal bypass and 138 limbs with endovascular peroneal intervention included, with mean follow-up of 24.0 ± 26.3 and 14.5 ± 19.1 months, respectively (P = .0001). The two groups were comparable in comorbidities, with the exception of the endovascular group's having more patients with cardiac and renal disease and diabetes mellitus but fewer patients with smoking history. Based on WIfI criteria, ischemia scores were worse in bypass patients, but wound and foot infection scores were worse in endovascular patients. Perioperatively, bypass patients had higher rates of myocardial infarction (4.5% vs 0%; P = .012) and incisional complications (13.0% vs 4.4%; P = .008). At 12 months, the bypass group compared with the endovascular group had better primary patency (47.9% vs 23.4%; P = .002) and primary assisted patency (63.6% vs 42.2%; P = .003) and a trend toward better secondary patency (74.2% vs 63.5%; P = .11). There were no differences in the rate of wound healing (52.6% vs 37.7% at 1 year; P = .09) or freedom from major amputation (81.5% vs 74.7% at 1 year; P = .37). In a multivariate analysis, neuropathy was associated with improved wound healing, whereas WIfI wound score, cancer, chronic renal insufficiency, and smoking were associated with decreased wound healing. Treatment modality was not a significant predictor (P = .15). CONCLUSIONS: Endovascular peroneal artery intervention results in poorer primary and primary assisted patency rates than surgical bypass to the peroneal artery but provides similar wound healing and limb salvage rates with a lower rate of complications. In appropriately selected patients, endovascular intervention to treat the peroneal artery is a low-risk intervention that may be sufficient to heal ischemic foot wounds.

Heel Wounds Predict Mortality but Not Amputation after Infrapopliteal Revascularization.

BACKGROUND: Ischemic heel ulcerations are generally thought to carry a poor prognosis for limb salvage. We hypothesized that patients undergoing infrapopliteal revascularization for heel wounds, either bypass or endovascular intervention, would have lower wound healing rates and amputation-free survival (AFS) than patients with forefoot wounds. METHODS: A retrospective chart review was performed on patients who presented between 2006 and 2013 to our institution with ischemic foot wounds and infrapopliteal arterial disease and underwent either pedal bypass or endovascular tibial artery intervention. Data were collected on patient demographics, comorbidities, wound characteristics, procedural details, and postoperative outcomes then analyzed by initial wound classification. The primary outcome was major amputation or death. RESULTS: Three hundred ninety-eight limbs underwent treatment for foot wounds; accurate wound data were available in 380 cases. There were 101 bypasses and 279 endovascular interventions, with mean follow-up of 24.6 and 19.9 months, respectively (P = 0.02). Heel wounds comprised 12.1% of the total with the remainder being forefoot wounds; there was no difference in treatment modality by wound type (P = 0.94). Of 46 heel wounds, 5 (10.9%) had clinical or radiographic evidence of calcaneal osteomyelitis. Patients with heel wounds were more likely to have diabetes mellitus (DM) (P = 0.03) and renal insufficiency (P = 0.004). 43.1% of wounds healed within 1 year, with no difference by wound location (P = 0.30). Major amputation rate at 1 year was 17.8%, with no difference by wound location (P = 0.81) or treatment type (P = 0.33). One- and 3-year AFS was 66.2% and 44.0% for forefoot wounds and 45.7% and 17.6% for heel wounds, respectively (P = 0.001). In a multivariate analysis, heel wounds and endovascular intervention were both predictors of death; however, there was significant interaction such that endovascular intervention was associated with higher mortality in patients with forefoot wounds (hazard ratio 2.25, P < 0.001) but not those with heel wounds (hazard ratio 0.67, P = 0.31). CONCLUSIONS: Patients presenting with heel ulceration who undergo infrapopliteal revascularization are prone to higher mortality despite equivalent rates of amputation and wound healing and regardless of treatment modality. These patients may benefit from an endovascular-first strategy.

Prior Endovascular Intervention Is Not Detrimental to Pedal Bypasses for Ischemic Wounds.

BACKGROUND: Endovascular strategies are often preferred for revascularization of ischemic foot wounds secondary to infrapopliteal disease because of the less invasive technique and faster recovery. Bypass is typically reserved for failures or lesions not amenable to balloon angioplasty. However, the effects of an endovascular-first approach on subsequent bypass grafts are largely unknown. This study evaluates the effects of prior endovascular tibial interventions (PTIs) on successive bypasses to pedal targets. METHODS: Patients who presented with ischemic tissue loss and tibial arterial occlusive disease to University of Pittsburgh Medical Center between 2006 and 2013 and underwent a surgical bypass to pedal arteries were included in this study. A retrospective chart review was conducted to obtain patient demographics, past medical history, extent of disease, prior tibial endovascular interventions, the treatment intervention, subsequent interventions, wound healing status, limb salvage, and patient survival. The primary outcome was primary patency of the pedal bypass graft. RESULTS: From 122 eligible patients, 27 had a PTI, whereas 95 had no prior endovascular tibial intervention (nPTI) in the treatment of ischemic pedal wounds with mean follow-up of 24.5 and 20.5 months, respectively (P = 0.36). The 2 groups were largely similar in terms of demographics, comorbidities, wound size, and degree of ischemia. Runoff scores between the 2 groups were also comparable (5.0 ± 1.6 for PTI and 4.8 ± 1.9 for nPTI, P = 0.59). The plantar artery was a more common target vessel in the PTI group, whereas the posterior tibial artery was targeted more often in the nPTI group (P = 0.04). At 12 months, those with a PTI exhibited a shorter primary patency (34.8% vs. 60.2%, P = 0.04). In a multivariate model, PTI was a significant risk factor for primary patency loss (hazard ratio 2.51, P = 0.004). Primary assisted patency and secondary patency were similar between the 2 groups. Wound healing was improved in those patients who had a prior endovascular intervention with 63.8% healed at 1 year compared with only 34.8% of those without intervention (P = 0.01). Amputation-free survival was similar (P = 0.68), as was survival alone (P = 0.50). CONCLUSIONS: Despite a decrease in primary patency, pedal bypass was not otherwise negatively affected by a PTI. Similar primary assisted patency, secondary patency, wound healing, and survival between the 2 patient populations indicate that an endovascular-first approach is a feasible treatment strategy to achieve similar clinical outcomes in the management of ischemic foot wounds.

Bypass versus endovascular intervention for healing ischemic foot wounds secondary to tibial arterial disease.

OBJECTIVE: Pedal (inframalleolar) bypass is a long-standing therapy for tibial arterial disease in patients with ischemic tissue loss. Endovascular tibial intervention is an appealing alternative with lower risks of perioperative mortality or complications. Our objective was to compare the effectiveness of these two treatment modalities with respect to patency and limb-related clinical outcomes. METHODS: We performed a retrospective chart review of patients presenting between 2006 and 2013 with ischemic foot wounds and infrapopliteal arterial disease who underwent a revascularization procedure (either open surgical bypass to an inframalleolar target or endovascular tibial intervention). Data were collected on baseline demographics and comorbidities, procedural details, and postprocedure outcomes. The primary outcome was successful healing of the index wound, with mortality, major amputation, and patency assessed as secondary outcomes. RESULTS: We identified 417 patients who met our eligibility criteria; 105 underwent surgical bypass and 312 underwent endovascular intervention, with mean follow-up of 25.0 and 20.2 months, respectively (P = .08). The endovascular patients were older at baseline (P = .009), with higher rates of hyperlipidemia (P = .02), prior cerebrovascular accidents (P = .04), and smoking history (P = .04). Within 30 days postoperatively, there was no difference in mortality (P = .31), but bypass patients had longer hospital length of stay (P < .0001), higher rate of discharge to nursing facility (P < .001), and higher rates of myocardial infarctions (P = .03) and wound complications (P < .001). At 6 months, the rate of wound healing was 22.4% in the bypass group compared with 29.0% in the endovascular group (P = .02). At 1 year, survival was higher after bypass (86.2% vs 70.4%; P < .0001), but freedom from major amputation was similar (84.9% vs 82.8%; P = .42). Primary patency (53.1% vs 38.2%; P = .002) and primary assisted patency (76.6% vs 51.7%; P < .0001) were higher in the bypass group, but there was no difference in secondary patency (77.3% vs 73.8%; P = .13). CONCLUSIONS: Endovascular tibial intervention is associated with poorer primary patency but similar secondary patency and wound healing rates compared with the "gold standard" of surgical bypass to a pedal target. In patients with tibial arterial disease, endovascular intervention should be considered a lower risk alternative to pedal bypass that provides similar clinical outcomes.

Cost-effectiveness analysis of drug-coated therapies in the superficial femoral artery.

OBJECTIVE: Drug-coated balloons (DCBs) may increase durability of endovascular treatment of superficial femoral artery (SFA) disease while avoiding stent-related risks. The purpose of this study was to use meta-analytic data of DCB studies to compare the cost-effectiveness of potential SFA treatments: DCB, drug-eluting stent (DES), plain old balloon angioplasty (POBA), or bare-metal stent (BMS). METHODS: A search for randomized controlled trials comparing DCB with POBA for treatment of SFA disease was performed. Hazard ratios were extracted to account for the time-to-event primary outcome of target lesion revascularization. Odds ratios were calculated for the secondary outcomes of primary patency (PP) and major amputation. Incorporating pooled data from the meta-analysis, cost-effectiveness analysis, assuming a payer perspective, used a decision model to simulate patency at 1 year and 2 years for each index treatment modality: POBA, BMS, DCB, or DES. Costs were based on current Medicare outpatient reimbursement rates. RESULTS: Eight studies (1352 patients) met inclusion criteria for meta-analysis. DCB outperformed POBA with respect to target lesion revascularization over time (pooled hazard ratio, 0.41; P < .001). Risk of major amputation at 12 months was not significantly different between groups. There was significantly improved 1-year PP in the DCB group compared with POBA (pooled odds ratio, 3.30; P < .001). In the decision model, the highest PP at 1 year was seen in the DES index therapy strategy (79%), followed by DCB (74%), BMS (71%), and POBA (64%). With a baseline cost of $9259.39 per patent limb at 1 year in the POBA-first group, the incremental cost per patent limb for each other strategy compared with POBA was calculated: $14,136.10/additional patent limb for DCB, $38,549.80/limb for DES, and $59,748,85/limb for BMS. The primary BMS option is dominated by being more expensive and less effective than DCB. Compared directly with DCB, DES costs $87,377.20 per additional patent limb at 1 year. Based on the projected PP at 1 year in the decision model, the number needed to treat for DES compared with DCB is 20. At current reimbursement, the use of more than two DCBs per procedure would no longer be cost-effective compared with DES. At 2 years, DCB emerges as the most cost-effective index strategy with the lowest overall cost and highest patency rates over that time horizon. CONCLUSIONS: Current data and reimbursements support the use of DCB as a cost-effective strategy for endovascular intervention in the SFA; any additional effectiveness of DES comes at a high price. Use of more than one DCB per intervention significantly decreases cost-effectiveness.

Drug-coated balloon angioplasty for dialysis access fistula stenosis.

Maintaining vascular access patency represents a tremendous challenge in hemodialysis patients. Although "native" arteriovenous fistula (AVF) is currently recommended as primary vascular access, neointimal hyperplasia stenoses frequently develop, with a risk for AVF thrombosis and vascular access loss. For years, first-line treatment of AVFs stenoses has been percutaneous transluminal angioplasty, generally with high-pressure or cutting uncoated balloons. However, restenosis and reintervention rates remain incredibly high and occur, according to recent studies, in up to 60% and 70% of patients at 6 and 12 months, respectively. Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel reduces neointimal hyperplasia and drug-coated balloons, therefore, it represents an attractive option for AVF stenoses. Because data are scarce, the aim of this paper was to review the concepts and current results of drug-coated balloons in AVF stenosis management.