Early Clinical Results From the Japanese Prospective Multicenter Study to Evaluate Zenith Alpha Abdominal Stent Graft for Abdominal Aortic Aneurysm (JUSTICE) Registry Demonstrate Acceptable Limb Patency at 12 Months.

PURPOSE: Recent reports of the Zenith Alpha abdominal endovascular graft (Zenith Alpha AAA, Cook, Inc., Bloomington, Indiana) have demonstrated an unexpectedly high incidence of limb graft occlusion (LGO). The purpose of this study was to prospectively evaluate the performance of the Zenith AAA in Japan, with a specific focus on LGO. MATERIALS AND METHODS: All endovascular aneurysm repairs (EVARs) for abdominal aortic aneurysms performed using the Zenith Alpha AAA from July 2020 to October 2021 in 23 Japanese hospitals were prospectively evaluated. All computed tomographic images were analyzed in the core laboratory. Late complications were defined as any aneurysm-related events occurring >30 days after EVAR, including aneurysm sac enlargement of >5 mm and any reinterventions performed. Endoleaks without sac enlargement or reintervention were excluded as late complications. RESULTS: During the study period, 147 EVARs were performed using the Zenith Alpha AAA. The mean patient age was 76.5±7.7 years, 84.4% of patients were male, and the mean aneurysm diameter was 52.4±9.2 mm. Instruction-for-use violations were observed in 76 patients (51.7%), primarily associated with a severely angulated proximal neck (>60°). There were six intraoperative complications and 62 additional intraoperative treatments reported, most of which involved preemptive coil embolization of the inferior mesenteric artery (37 cases). Technical success, defined as the absence of type 1 or 3 endoleaks on final angiography, was achieved in 99.3% of patients. At 12 months, there was only one case of type 1/3 endoleak (0.8%) and one aneurysm sac enlargement exceeding 5 mm (0.8%); however, a high incidence of type 2 endoleaks was observed in 35.2% of patients, and aneurysm sac regression exceeding 5 mm was achieved in 30.1% of patients. Nine late complications were observed, and the rate of freedom from late complications at 12 months was 93.5%, encompassing four LGOs and one limb graft stenosis (3.4%). CONCLUSIONS: In contrast to recent reports, our Japanese multicenter prospective study demonstrated satisfactory early clinical results, including an acceptable LGO rate, for the low-profile Zenith Alpha AAA. Long-term follow-ups will be performed to confirm the persistence of these outcomes. CLINICAL IMPACT: This study prospectively evaluated the performance of 147 Zenith Alpha AAAs used for endovascular aneurysm repair with core-lab adjudication focusing especially on limb graft occlusion (LGO). At 12 months, aneurysm sac regression exceeding 5 mm was achieved in 30.1% of patients, and there was only one type 1/3 endoleak, one aneurysm sac enlargement (>5 mm), and nine late complications including five LGOs (3.4%), resulting in rate of freedom from late complications at 93.5%. Satisfactory early clinical results, including an acceptable rate of LGO can be achieved, particularly with cautious usage of the Zenith Alpha Spiral-Z Endovascular Leg." 5mm), and nine late complications including five LGOs (3.4%), resulting in rate of freedom from late complications at 93.5%. Satisfactory early clinical results, including an acceptable rate of LGO can be achieved, particularly with cautious usage of the Zenith Alpha Spiral-Z Endovascular Leg.

One-Year Clinical Outcomes and Prognostic Factors Following Revascularization in Patients With Acute Limb Ischemia　- Results From the RESCUE ALI Study.

BACKGROUND: Acute limb ischemia (ALI) is a limb- and life-threatening condition and urgent treatment including revascularization should be offered to patients unless the limb is irreversibly ischemic. The aim of this study was to investigate 1-year clinical outcomes and prognostic factors following revascularization in patients with ALI.Methods and Results: A retrospective, multicenter, nonrandomized study examined 185 consecutive patients with ALI treated by surgical revascularization (SR), endovascular revascularization (ER), or hybrid revascularization (HR) in 6 Japanese medical centers from January 2015 to August 2021. The 1-year amputation-free survival (AFS) rate was estimated to be 69.2% (95% confidence interval [CI], 62.8-76.2%). There were no significant differences among SR, ER, and HR regarding both technical success and perioperative complications. Multivariate analysis revealed that Rutherford category IIb and III ischemia (hazard ratio [HR]: 1.86; 95% CI: 1.06-3.25), supra- to infrapopliteal lesion (HR: 2.06; 95% CI: 1.08-3.95), and technical failure (HR: 2.58; 95% CI: 1.49-4.46) were independent risk factors for 1-year AFS. CONCLUSIONS: Rutherford category IIb and III ischemia, supra- to infrapopliteal lesions, and technical failures were identified as independent risk factors for 1-year AFS. Furthermore, patients with multiple risk factors had a lower AFS rate.

Physician-modified inner-branched endovascular repair with re-intervention.

OBJECTIVES: Treatment of thoracoabdominal aortic aneurysms in high surgical risk patients can be challenging. Reports of physician-modified inner-branched endovascular repair (PMiBEVAR) are increasing. Despite low morbidity and mortality rates, re-interventions for endoleaks with these grafts are serious. There are no reports of additional treatment for PMiBEVAR failure. METHODS/RESULTS: A 75-year-old man presented to our hospital with a Crawford's type IV thoracoabdominal aortic aneurysm. A PMiBEVAR was performed. Postoperative computed tomographic angiography revealed an endoleak from the inner branch of the right renal artery. A re-intervention was performed with coil embolization of the endoleak. Imaging after re-intervention showed successful obliteration of the endoleak. CONCLUSIONS: We thereby report a successful case of re-intervention for PMiBEVAR failure.

Intraoperative evaluation for endoleaks using the SCORPION procedure during endovascular aortic repair.

OBJECTIVES: Endoleaks are important complications of endovascular aortic repair. Usually, endoleaks are judged indirectly by aortography or postoperative computed tomography. However, findings from these modalities are difficult to distinguish because of the divergency of endoleaks. Few studies have reported direct visualization of endoleaks. Herein, we introduce a direct procedure for intraoperatively evaluating endoleaks using angioscopy. METHODS: From April 2023, consecutive patients with an abdominal aortic aneurysm, except emergency cases and those of narrow access, seen at Sunagawa City Medical Center were enrolled in our study. Endoleaks were detected by intraoperative angioscopy using a novel endovascular procedure. RESULTS: Seven patients underwent endovascular aortic repair of an abdominal aortic aneurysm with intraoperative angioscopy. None of the enrolled patients experienced complications. The procedure revealed types 2, 3a, and 4 endoleaks. CONCLUSIONS: This is the first study to demonstrate intraoperative visualization of endoleaks using angioscopy. Direct findings observed by this novel procedure might provide information on the velocity and volume of the endoleak, providing comprehensive insights into the intra-sac hemodynamics after the endovascular aortic repair.

Initial Outcomes of Physician-Modified Inner Branched Endovascular Repair in High-Surgical-Risk Patients.

PURPOSE: To report the initial outcomes of physician-modified inner branched endovascular repair (PMiBEVAR) for pararenal aneurysms (PRAs), thoracoabdominal aortic aneurysms (TAAAs), and aortic arch aneurysms in high-surgical-risk patients. MATERIALS AND METHODS: A total of 10 patients (6 men; median age, 83.0 years) treated using PMiBEVAR were enrolled in this retrospective, single-center study. All patients were at high surgical risk because of severe comorbidities (American Society of Anesthesiologists physical status score≥3 or emergency repair). End points were defined as technical success per patient and per vessel (successful deployment), clinical success (no endoleaks postoperatively), in-hospital death, and major adverse events. RESULTS: There were 3 PRAs, 4 TAAAs, and 3 aortic arch aneurysms with 12 renal-mesenteric arteries and 3 left subclavian arteries incorporated by inner branches. The technical success rate was 90.0% (9/10) per patient and 93.3% (14/15) per vessel. The clinical success rate was 90% (9/10). There were 2 in-hospital deaths, unrelated to aneurysms. Paraplegia and shower emboli occurred separately in 2 patients. Three patients experienced prolonged ventilation for 3 days after surgery. Aneurysm sac shrinkage occurred in 4 patients, and aneurysm size stabilized in 1 patient during follow-up, more than 6 months later. None of the patients required intervention. CONCLUSION: PMiBEVAR is a feasible approach for treating complex aneurysms in high-surgical-risk patients. This technology may complement the existing technology in terms of improved anatomical adaptability, no time delay and practicability in many countries. However, long-term durability remains undetermined. Further large-scale and long-term studies are needed. CLINICAL IMPACT: This is the first clinical study to investigate outcomes of physician-modified inner branched endovascular repair (PMiBEVAR). PMiBEVAR for treating pararenal aneurysm, thoracoabdominal aortic aneurysm, or aortic arch aneurysm is a feasible procedure. This technology is likely to complement existing technology in terms of improved anatomical adaptability (compared to off-the-shelf devices), no time delay (compared to custom-made devices), and the potential to be performed in many countries. On the other hand, surgery time varied greatly depending on the case, suggesting a learning curve and the need for technological innovation to perform more consistent surgeries.

One Year Outcomes of Zilver PTX Versus Eluvia for Femoropopliteal Disease in Real-World Practice: REALDES Study.

PURPOSE: This multicenter, prospective, observational study aimed to compare Zilver PTX and Eluvia stents in real-world settings for treating femoropopliteal lesions as the differences in the 1-year outcomes of these stents have not been elucidated. MATERIALS AND METHODS: Overall, 200 limbs with native femoropopliteal artery disease were treated with Zilver PTX (96 limbs) or Eluvia (104 limbs) at 8 Japanese hospitals between February 2019 and September 2020. The primary outcome measure of this study was primary patency at 12 months, defined as a peak systolic velocity ratio of ≤2.4, without clinically-driven target lesion revascularization (TLR) or stenosis ≤50% based on angiographic findings. RESULTS: The baseline clinical and lesion characteristics of Zilver PTX and Eluvia groups were roughly comparable (of all limbs analyzed, approximately 30% presented with critical limb-threatening ischemia, approximately 60% presented with Trans-Atlantic Inter-Society Consensus II C-D, and approximately half had total occlusion), except for the longer lesion lengths in the Zilver PTX group (185.7±92.0 mm vs 160.0±98.5 mm, p=0.030). The Kaplan-Meier estimates of primary patency at 12 months were 84.9% and 88.1% for Zilver PTX and Eluvia, respectively (log-rank p=0.417). Freedom from clinically-driven TLR rates were 88.8% and 90.9% for Zilver PTX and Eluvia, respectively (log-rank p=0.812). CONCLUSIONS: The results of the Zilver PTX and Eluvia stents were not different regarding primary patency and freedom from clinically-driven TLR at 12 months after treating patients with femoropopliteal peripheral artery disease in real-world settings. CLINICAL IMPACT: This is the first study to reveal that the Zilver PTX and Eluvia have similar results in real-world practice when the proper vessel preparation is performed. However, the type of restenosis in the Eluvia stent may differ from that in the Zilver PTX stent. Therefore, the results of this study may influence the selection of DES for femoropopliteal lesions in routine clinical practice.

Design, synthesis and biological evaluation of novel 1H-pyrazole-4-carbonyl-4,5,6,7-tetrahydrobenzo [b]thiophene derivatives as gut-selective NaPi2b inhibitors.

Intestinal sodium-dependent phosphate transport protein 2b (SLC34A2, NaPi2b) inhibitors are expected to be potential new candidates for anti-hyperphosphatemia drugs. However, a risk of on-target side effects based on the inhibition of NaPi2b in the lung and testis has been reported. To identify gut-selective (minimally systemic) NaPi2b inhibitors, we prepared and evaluated 1H-pyrazole-4-carbonyl-4,5,6,7-tetrahydrobenzo[b]thiophene derivatives with highly polar functional groups to reduce systemic exposure. As a result, compounds 36a and 36b showed a good activity in vitro and a low bioavailability in Sprague-Dawley (SD) rats. However, these compounds did not suppress phosphate absorption in SD rats. This lack of in vivo efficacy could be due to the high hydrophobicity of these compounds. The results of further investigations of other classes of compounds with appropriate physical properties will be reported in due course.

Design, synthesis and biological evaluation of novel pyridine derivatives as gut-selective NaPi2b inhibitors.

We previously reported thiophene derivatives as gut-selective (minimally systemic) and potent sodium-dependent phosphate transport protein 2b (SLC34A2, NaPi2b) inhibitors. However, these derivatives did not suppress phosphate absorption form the intestinal tract in Sprague-Dawley (SD) rats. The lack of efficacy in vivo could be due to the high hydrophobicity of these compounds. In this report, we identified novel pyridine derivatives as gut-selective NaPi2b inhibitors with good activity in vitro and relatively low hydrophobicity. Especially, gut-selective compound 20b suppressed phosphate absorption in SD rats. These results suggest that physical properties, such as the hydrophobicity of the compounds, might affect the in vivo efficacy.

Design, synthesis and biological evaluation of novel indole derivatives as gut-selective NaPi2b inhibitors.

Intestinal sodium-dependent phosphate transport protein 2b (SLC34A2, NaPi2b) inhibitors are expected to be potential new candidates for anti-hyperphosphatemia drugs. However, a risk of on-target side effects based on the inhibition of NaPi2b in the lung and testis has been reported.In this article, we report on our identification of novel indole derivatives as gut-selective NaPi2b inhibitors with good activity, low systemic exposure and moderate hydrophobicity.In particular, gut-selective compound 27, with even lower bioavailability and lower systemic exposure as compared to previously reported pyridine derivatives, demonstrated excellent phosphate absorption-inhibitory effect in SD rats. Compound 27 has an ideal profile and appears to offer promise as a candidate drug for the treatment of hyperphosphatemia, with minimal risk of side effects due to systemic exposure.

Improvement of predicted hematocrit values after the initiation of cardiopulmonary bypass in cardiovascular surgery.

Hematocrit (Hct) values after the initiation of cardiopulmonary bypass (CPB) must be maintained appropriately to avoid perioperative complications. Therefore, an accurate prediction is required. However, the standard prediction equation often results in actual values that are lower than the predicted values. This study aimed to clarify the limits of agreement (LOA) and bias of the prediction equations and investigate better the prediction equations. A retrospective study was performed on adult patients between April 2015 and December 2020. Study 1 included 158 patients, and Study 2 included 55 patients. The primary outcomes were the LOA and bias between the predicted and measured Hct values after the initiation of CPB, and two studies were conducted. In Study 1, total blood volume (TBV) was estimated, and the new blood volume index (BVI) was calculated. BVI was also evaluated for the overall value and gender differences. Therefore, the patient's background was compared by gender differences. In, Study 2 the conventional predicted equation (Eq. 1), the predicted equation using the new BVI (Eq. 2), and the predicted equation using the new BVI including physiological factors in the TBV equation (Eq. 3) were compared. In Study 1, BVI was 53 (44-67) mL/kg. In Study 2, bias ± LOA was - 2.5 ± 6.8% for Eq. 1, 0.1 ± 6.6% for Eq. 2, and 0.4 ± 6.2% for Eq. 3. The new equation is expected to predict the Hct value after the initiation of CPB with better LOA and bias than the conventional equation.

Changes in Skin Perfusion Pressure After Endovascular Treatment for Chronic Limb-Threatening Ischemia.

PURPOSE: To assess skin perfusion pressure (SPP) changes after endovascular treatment (EVT) of patients with chronic limb-threatening ischemia (CLTI) and to explore preoperative factors that affect SPP changes. MATERIALS AND METHODS: This prospective, multicenter study recruited 147 patients (mean age 74 years; 99 men) with ischemic wounds at 6 vascular centers in Japan between July 2017 and December 2018. Over half of the patients (92, 63%) were diabetic, and 76 (52%) required dialysis. Sixty-four patients (43%) had WIfI (wound, ischemia, foot infection) wound grades of 2 or 3; 59 (40%) had foot infections. SPP was measured before and 1, 2, 7, and 30 days after EVT to establish inline flow to the ischemic foot based on the angiosome concept when feasible. The anterior and posterior tibial arteries and the peroneal artery were revascularized in 66 (45%), 50 (34%), and 30 (21%) patients, respectively. RESULTS: Both the dorsal and plantar SPPs at 1 or 2 days post-EVT were significantly higher than those at baseline (p<0.001), and both SPPs increased further at 1 month compared with those at 1 (p=0.001) or 2 days (p=0.006) post-EVT. SPP increases occurred on the dorsal and plantar surfaces of the foot regardless of the vessel revascularized. The SPP increase at 1 month after EVT was significantly lower in patients with foot infections than that in those without foot infections (p=0.003). Age, sex, diabetes, dialysis, wound severity, and direct revascularization did not affect the pattern of SPP change. CONCLUSION: The SPP increased continuously up to 1 month after EVT, though the increase was smaller in patients with wound infections. The SPP on the dorsal and plantar surfaces increased, regardless of the vessel revascularized, which could justify indirect revascularization when direct revascularization is technically challenging.

Two-Year Results of a Multicenter Prospective Observational Study of the Zenith Spiral-Z Limb Deployed in the External Iliac Artery During Endovascular Aneurysm Repair.

BACKGROUND: Limited data is available on the use of a polyester graft limb with a helical stent configuration deployed in the external iliac artery (EIA) during endovascular aneurysm repair (EVAR), so we prospectively analyzed the efficacy of the Zenith Spiral-Z limb deployed in the EIA.Methods and Results:Patients undergoing EVAR using a Zenith stent-graft and Spiral-Z limb deployed in the EIA were prospectively registered in 24 Japanese institutions from June 2017 to November 2017. In total, 65 patients (74 limbs) (mean age: 77.1±8.0 years, 87.7% men, mean abdominal aortic aneurysm (AAA) diameter: 51.9±7.2 mm, mean iliac artery aneurysm (IAA) diameter: 38.3±10.0 mm) were registered and followed up. The most common reason for deployment in the EIA was a common IAA (43 limbs, 58.1%), and 8 limbs (10.8%) had a bare nitinol stent placed at the Spiral-Z limb. A total of 61 patients (70 limbs) completed a 24-month follow-up. There were 2 Spiral-Z limb stenoses and 1 occlusion, leading to a primary patency of 95.5% and a secondary patency of 100%, at 24 months. Buttock claudication occurred in 24.3% of the limbs treated at 1 month but decreased to 4.3% at 24 months. CONCLUSIONS: Our multicenter prospective study showed that Spiral-Z limb deployed in the EIA was associated with satisfactory results and seems to be a durable option, even in the era of iliac branch devices.

Vessel Calcification as a Risk Factor for In-Stent Restenosis in Complex Femoropopliteal Lesions After Zilver PTX Paclitaxel-Coated Stent Placement.

Purpose: To evaluate the effect of vessel calcification on in-stent restenosis (ISR) after drug-coated stent (DCS) placement in the femoropopliteal segment. Materials and Methods: A retrospective multicenter study was undertaken involving 220 consecutive symptomatic patients (mean age 73.1±8.3 years; 175 men) with femoropopliteal lesions in 230 limbs treated with the Zilver PTX DCS and having duplex surveillance after the endovascular procedures. Mean lesion length was 16.4±9.8 cm (range 2-40); there were 104 (45.2%) total occlusions and 68 (29.6%) in-stent restenoses (ISR). Twenty (8.7%) vessels had no runoff. The majority of lesions (148, 64.3%) were calcified according to the peripheral arterial calcium scoring system (PACSS). Primary patency was evaluated by duplex. Lesions were classified as either PACSS 0-2 (none or unilateral wall calcification) or PACSS 3 and 4 (bilateral wall calcification). Multivariate analysis was performed to identify variables associated with ISR; the results are given as the hazard ratio (HR) and 95% confidence interval (CI). Results: The 1-, 2-, and 5-year primary patency and freedom from clinically-driven target lesion revascularization estimates were 75.9%, 63.6%, and 45.0%, and 84.7%, 73.7%, and 54.2%, respectively. Major amputations were performed on 4 limbs during follow-up. In multivariate analysis, vessel calcification (adjusted HR 1.718, 95% CI 1.035 to 2.851, p=0.036) was significantly correlated with the occurrence of ISR, along with lesion length (adjusted HR 1.041, 95% CI 1.013 to 1.070, p=0.003), and cilostazol administration (adjusted HR 0.476, 95% CI 0.259 to 0.876, p=0.017). Conclusion: This study suggested that bilateral vessel wall calcification was an independent risk factor for ISR in complex femoropopliteal lesions after Zilver PTX DCS placement, along with lesion length; cilostazol administration had a protective effect.

[Surgery for Flail Chest with Titanium Plates after Cardiopulmonary Resuscitation;Report of a Case].

A 74-year-old woman was admitted for the management of nausea with hyponatremia. On the 19th day of hospitalization, the patient developed cardiac arrest and needed cardiopulmonary resuscitation (CPR). CPR was successful but the patient developed multiple rib fractures with flail chest by CPR. Because of persistent dyspnea, surgery for fixing of the fractured ribs was performed using 4 titanium plates, with prompt improvement of the flail chest after the operation.

Discovery of novel 2-[(4-hydroxy-6-oxo-2,3-dihydro-1H-pyridine-5-carbonyl)amino]acetic acid derivatives as HIF prolyl hydroxylase inhibitors for treatment of renal anemia.

Prolyl hydroxylase domain-containing protein (PHD) inhibitors are useful as orally administered agents for the treatment of renal anemia. Based on the common structures of known PHD inhibitors, we found novel PHD inhibitor 1 with a 2-[(4-hydroxy-6-oxo-2,3-dihydro-1H-pyridine-5-carbonyl)amino]acetic acid motif. The PHD2-inhibitory activity, lipophilicity (CLogP), and PK profiles (hepatocyte metabolism, protein binding, and/or elimination half-life) of this inhibitor were used as the evaluation index to optimize the structure and eventually discovered clinical candidate 42 as the suitable compound. Compound 42 was demonstrated to promote the production of erythropoietin (EPO) following oral administration in mice and rats. The predicted half-life of this compound in humans was 1.3-5.6 h, therefore, this drug may be expected to administer once daily with few adverse effects caused by excessive EPO production.

Predictive Factors for Abdominal Aortic Aneurysm Shrinkage One Year after Successful Endovascular Aneurysm Repair.

BACKGROUND: Often, we experience cases of aneurysm shrinkage and no aneurysm shrinkage after successful endovascular aortic aneurysm repair, without postoperative endoleaks. We studied these cases to ascertain the predictive factors for aneurysm shrinkage. METHODS: From 2007 to 2014, we selected 255 cases that comprised aneurysm shrinkage (>4 mm) and no-shrinkage cases (shrinkage from 0 to 4 mm). Excluding 36 cases of endoleaks, 43 cases without 1-year follow-up computed tomography scan, and 3 cases of aortic dissection, we assessed 93 cases of aneurysm shrinkage (S group) and 80 cases of no aneurysm shrinkage (N group) at 1-year follow-up. RESULTS: No significant differences were found in sex, comorbidities (diabetes mellitus, chronic kidney disease, hemodialysis, and malignancy), and medications (antiplatelet drugs, anticoagulant drugs, steroids, and statins). Advanced age was a strong negative predictive factor for aneurysm shrinkage (N: 75.0 ± 1.0 vs. S: 72.1 ± 0.9 years; P = 0.023), and intraoperative endoleaks were more frequent in the N group (N: 31.3 vs. S: 9.7%; P = 0.001). Neck thrombus was more likely in the N group (N: 17.5 vs. S: 7.5%; P = 0.045), but it had a strong correlation with intraoperative endoleaks (P = 0.008). In the multivariate analysis, patient age and intraoperative endoleaks were predictive factors for aneurysm shrinkage. CONCLUSIONS: Advanced age and intraoperative endoleaks were negative predictive factors for aneurysm shrinkage at 1-year follow-up after successful endovascular treatment without postoperative endoleaks.

[Infectious Endocarditis due to Methicillin-sensitive Bovine Staphylococcus aureus;Report of a Case].

A 19-year-old male patient was admitted to our hospital after developing infectious endocarditis associated with methicillin-sensitive bovine Staphylococcus aureus septicemia. Brain magnetic resonance imaging confirmed occipital lobe cerebral bleeding. An echocardiogram showed severe mitral regurgitation with vegetation on the posterior mitral leaflet. We performed mitral valve replacement. However, a hepatic artery aneurysm and a ruptured splenic artery aneurysm was found on the 5th postoperative day and coil embolization was accordingly performed. The patient suffered repeated cerebral bleeding and received external decompression. He was discharged on the 92nd day after the valve replacement. Our case is rare in that methicillin-sensitive bovine Staphylococcus aureus isolated from human is extremely unusual especially complicated by multiple peripheral aneurysms. This is the 1st reported case of methicillin-sensitive bovine Staphylococcus aureus isolated from human in the Japanese literature.

Physician-Modified Thoracic Stent-Grafts for the Treatment of Aortic Arch Lesions.

PURPOSE: To evaluate outcomes of physician-modified thoracic stent-grafts for the treatment of aortic arch aneurysms. METHODS: A retrospective dual-center analysis was performed involving 36 patients (mean age 74.7±9 years, range 58-91; 27 men) with an aortic arch lesion who were treated between November 2013 and June 2016 using physician-modified thoracic stent-grafts. Half of the patients had a degenerative aneurysm; the remainder had type B dissection (n=9), traumatic transection (n=3), type Ia endoleak after previous endografting (n=5), or aortoesophageal fistula (n=1). All patients were considered to be at high surgical risk. Patients were treated using an aortic arch stent-graft with a single fenestration (n=24) or a proximal scallop (n=12); zone 0 was involved in 16 patients, zone 1 in 9, and zone 2 in 11. The modified thoracic stent-graft was deployed after supra-aortic branch revascularization in 24 (67%) patients. RESULTS: Mean time required for stent-graft modifications was 18 minutes (range 14-21). Technical success was obtained in all cases with no type I endoleak. One (3%) patient had a stroke without permanent sequelae. The 30-day mortality was 6%. During a mean follow-up of 11.4±6 months (range 2-36), there were no conversions to open repair. The overall mortality was 14%; aorta-related mortality was 6%. CONCLUSION: Our experience suggests that physician-modified thoracic stent-grafts are feasible for aortic arch lesions and provide encouraging results in the short term. Durability concerns will need to be assessed.