Sirolimus-Coated Balloon in Femoropopliteal Steno-Occlusive Disease: Efficacy, Safety, and 1-Year Outcomes. An All-Comers Registry.

PURPOSE: The aim of this study was to assess the efficacy and safety of the novel SLR (SELUTION sustained-limus-release) drug-coated balloon (DCB) in the treatment of the femoropopliteal steno-occlusive disease. MATERIALS AND METHODS: From February 2021 to March 2022, 80 consecutive patients (age: 69.5±8.23 years; total number of lesions: 80) with a steno-occlusive lesion of superficial femoral artery were enrolled at our center. A total of 60 patients (75%) had claudication, whereas 20 (25%) had chronic limb-threatening ischemia (CLTI). The mean lesion length was 171±82.22 mm. The primary efficacy outcome was primary patency at 12 months, defined as freedom from restenosis determined by a duplex ultrasound peak systolic velocity ratio ≤2.4. The secondary efficacy outcome was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months. The primary safety outcome was a composite of freedom from device- and procedure-related mortality, major target limb amputation, and clinically-driven target lesion urgent revascularization (endovascular or bypass graft) at 30 days and 12 months. RESULTS: Device success was achieved in all 80 patients. One death on day 7 from cardiovascular complications was ruled procedure-related because it occurred within the first 30 days from the discharge. Two patients with CLTI experienced planned minor amputations of target limb, and one patient underwent urgent bypass graft of the target vessel for early occlusion at 60 days from the index procedure. The primary safety outcome was 98.7% and 97.5% at 30 days and 12 months, respectively. At 1 year, primary patency was 86.3%, and freedom from CD-TLR was 96.2%. CONCLUSION: These findings suggest that using a novel sirolimus-coated balloon is a safe and effective treatment option for femoropopliteal steno-occlusive lesions in a variety of clinical and anatomical settings. These results will need to be confirmed by long-term follow-up and randomized controlled trials. CLINICAL IMPACT: In femoropopliteal steno-occlusive lesions paclitaxel drug-coated devices have been proved to be able to achieve a better vessel patency during follow-up compared with uncoated balloon, but according to a recent meta-analysis they may carry an elevated risk of late mortality. Sirolimus results in a wider therapeutic range with a 3-fold higher margin of safety. Sirolimus coated devices have recently been proposed as an alternative. This study suggests that using a novel sirolimus-coated balloon is a safe and effective treatment option for femoropopliteal steno-occlusive lesions.

Assessing the impact of transcatheter aortic valve replacement on myocardial work indices and left ventricular diastolic function in aortic valve stenosis patients.

BACKGROUND: Aortic valve stenosis (AS) is the most common valvular heart disease worldwide. When timely intervention is performed, aortic valve replacement can improve patients' quality and duration of life. Load-independent left ventricular (LV) functional assessments, such as myocardial work indices (MWIs) and LV diastolic function parameters, could help clinicians decide on the optimal timing of intervention. AIMS: To evaluate the reliability of MWI in AS patients and the changes in MWI and LV diastolic function after transcatheter aortic valve replacement (TAVR). METHODS: We enrolled 53 consecutive patients with severe AS undergoing TAVR admitted between March 2021 and November 2021. MWIs and LV diastolic function were assessed before and after TAVR for each patient. RESULTS: All MWIs and LV diastolic function indices improved after TAVR. The degree of MWIs improvement was higher in patients with lower prior-TAVR MWI values, while the more severe the impairment of diastolic function, the greater the post-TAVR benefit. CONCLUSION: The introduction of myocardial work parameters into the routine assessment of patients with AS could improve our understanding of cardiac performance and aid in identifying the optimal timing for surgical or percutaneous treatment.

Carotid Artery Stenting Using Five-French Distal Radial Vascular Access.

Carotid artery stenting (CAS) is usually performed through a femoral vascular access using 6-9 Fr guiding catheters. We investigated whether a systematic distal radial approach using 5 Fr guiding sheaths was a safe and effective alternative to transfemoral approach for CAS. From July 2020 to October 2022, two operators at our center systematically performed CAS using a 5 Fr distal radial approach in consecutive patients. The main endpoints of the study were procedural success via distal radial and via proximal or distal radial access. The learning curve was evaluated by comparing the first half of patients versus the second half of patients enrolled. Procedural data and 30-day clinical outcomes were collected. Fifty-one patients were prospectively enrolled. CAS was effectively performed via distal radial access in 45 patients (88%). Overall radial artery success was 92%. Distal radial CAS was successfully performed in 20 out of the first 25 patients enrolled (80%), and in 25 of the last 26 patients enrolled (96%; p = 0.07). Significantly less contrast was administered in the last 26 patients compared to the first 25 enrolled (110 (70, 140) mL vs. 120 (107, 150) mL; p = 0.045). Radial artery occlusion was reported in 1 patient (2%). Only 1 minor stroke (2%) was reported in-hospital and at 30-day follow-up. In conclusion, distal radial CAS using 5 Fr catheters was a safe procedure with a high success rate. The procedure had a relatively short learning curve in operators familiar with transfemoral CAS.

Combined therapy with rotational atherectomy and drug coated balloon for superficial femoral artery in-stent restenosis: safety, efficacy, and two-year results of a single center experience.

BACKGROUND: The primary patency rate of superficial femoral artery (SFA) after percutaneous transluminal angioplasty (PTA) has improved with the use of self-expanding stents. However, occurrence of in-stent restenosis (ISR) still represents a frequent problem. Despite different studies have assessed the role of atherectomy and drug coated balloons (DCBs), no long-term data exist about combined use. The aim of this study was to evaluate safety and efficacy of combined treatment with Jetstream (Boston Scientific Corp., Marlborough, MA, USA) atherectomy and DCB for SFA intrastent restenosis (ISR) at 2-year follow-up. METHODS: 30 patients treated with PTA from November 2018 to September 2019 at Montevergine Clinic (Mercogliano, Avellino, Italy) were included in this analysis. All patients underwent PTA of SFA-ISR with Jetstream Atherectomy System followed by paclitaxel eluting balloon treatment. Patients were evaluated at 30 days, and every 3 months up to 24. RESULTS: Technical and procedural success was achieved in every patient. No in-hospital major adverse cardiac and cerebrovascular events occurred. No acute and sub-acute(in-hospital) procedure related complications occurred. During follow-up, 1 patient died due to stroke. Primary patency rate at 12 months was 93.4%. Primary patency rate at 24 months was 83.4%. Secondary patency rate at 24 months was 96.7%. One minor amputation, planned before treatment, was performed in the first 30 days. CONCLUSIONS: Our data suggest that combined therapy with Rotational Atherectomy and DCBs for SFA-ISR represents a safe and effective procedure with a high rate of primary patency at 2-year follow-up.

Three-year outcome of directional atherectomy and drug coated balloon for the treatment of common femoral artery steno-occlusive lesions.

BACKGROUND: Endarterectomy is considered the gold standard therapy for common femoral artery (CFA) steno-occlusive lesions, but a significant risk of perioperative mortality and complications has been reported. OBJECTIVE: Aim of this study is to evaluate the efficacy at a long-term follow-up of patients with CFA steno-occlusive lesions treated with directional atherectomy and drug coated balloon (DCB). MATERIAL AND METHODS: In this single-center registry, 78 patients (male: 80.7%; age: 71 ± 15 years; occlusions: 25%) with 80 CFA lesions were included, with 39.7% of them undergoing directional atherectomy and drug coated balloon due to critical limb ischemia and 60.3% due to lower-limb intermittent claudication. The long-term follow-up was completed by 75 patients (3 years). The 31 patients with critical ischemia (39.7%) were further subdivided into 20 (25.6%) patients with pain at rest and 11 (14.1%) with trophic changes, ulcers and/or tissue loss. We considered the primary and the secondary outcome, referring, respectively to peak systolic velocity ratio (PSVR) ≥ 2.4 on duplex or > 50% stenosis on digital subtraction angiography at 36 months and to clinically driven target lesion revascularization at 36 months. RESULTS: The primary and secondary outcome was obtained in 84% and 86.7% of patients, at 36 months of follow up. Bailout stenting was necessary in 6/80 cases (7.5%) for suboptimal result. Freedom from MALE was obtained in 98.6% of patients. CONCLUSIONS: These results confirm that directional atherectomy and drug coated balloon strategy for the treatment of CFA lesions is effective at a long-term follow-up and could be considered as a good alternative to surgery.

Prosthesis depth and conduction disturbances after last generation balloon-expandable transcatheter aortic valve implantation.

Aims: Preliminary data on Sapien 3 valve (S3-THV) use for transcatheter aortic valve implantation have shown an increased permanent pacemaker implantation (PPMI) rate with respect to Sapien XT valve. Aim of this study was to investigate the role of S3-THV position in the left ventricular outflow tract (LVOT) on electrocardiographic changes suggestive of atrioventricular (ΔPR) and/or intraventricular (ΔQRS) conduction abnormalities and 30 days PPMI rate. Methods and results: Eighty-six consecutive patients treated with S3-THV were included in the study. All patients underwent clinical and electrocardiogram evaluation. Left ventricular outflow tract prosthesis depth was assessed by fluoroscopy and expressed quantitatively (mm) and as aorto-ventricular ratio (AVR). Eight patients (9.3%) needed PPMI at 30 days. A low AVR (≤60/40) predicted PPMI (OR = 6.09, 95% CI 1.19-31.01, P = 0.030) and resulted into higher PPMI rate, compared with higher AVR (30.0 vs. 6.6%, P = 0.017). For each millimetre increase in the LVOT prosthesis depth PPMI risk increased by 1.41 times (95% CI 1.06-1.87, P = 0.017). In patients with low AVR, ΔPR was higher than in those with higher AVR (33.4 ± 56.7 vs. 12.1 ± 19.4 ms, P = 0.021) and ΔPR was associated to LVOT prosthesis depth (ß = 0.286, P = 0.009). Furthermore, ΔPR was associated with risk of PPMI (OR = 1.03, 95% CI 1.01-1.06, P = 0.024). Conclusions: A low AVR is associated to higher ΔPR and PPMI rates. The correlation between LVOT prosthesis depth with ΔPR and higher PPMI rate suggests the need of a careful S3-THV implantation.

Peripheral arterial disease and cardiovascular risk in Italy. Results of the Peripheral Arteriopathy and Cardiovascular Events (PACE) study.

OBJECTIVE: Our knowledge about the natural history of peripheral arterial disease (PAD) is derived from studies carried out almost exclusively in northern European and northern American populations. This study was aimed at defining mortality and cardiovascular morbidity of PAD patients in Italy. METHODS: From the lists of seven general practitioners, we identified all subjects aged 40-80 years (n = 4352). Of those reporting leg symptoms while walking at the Rose Questionnaire (n = 760), 60 (1.6% of the general population) had PAD, as evidenced by an ankle-brachial index of < 0.90 or reduced Doppler flow velocity. For each PAD patient, three sex and age-matched controls negative to the Rose Questionnaire were randomly selected from the general practice lists. RESULTS: After 24 months of follow-up, 15% of PAD patients died, 8% from cardiovascular disease, and 25% developed a non-fatal cardiovascular event. At Cox analysis, the presence of PAD was associated with an increased risk of all-cause mortality (relative risk 4.03; 95% confidence interval 1.50-10.84; P = 0.006), cardiovascular mortality (relative risk 7.77; 95% confidence interval 1.51-40.16; P = 0.014), and non-fatal cardiovascular events (relative risk 3.11; 95% confidence interval 1.41-6.80; P = 0.005). CONCLUSIONS: This Italian study shows that, in general practice, symptomatic PAD is associated with a four-fold increased risk of mortality and a nearly eight-fold increased risk of cardiovascular mortality. These figures are quite similar to those reported in northern European and northern American populations. General practitioners, who are the clinicians primarily and largely responsible for the care of these patients, should be alerted to the consequences of PAD.