Does Renal Denervation a Reasonable Treatment Option in Hemodialysis-Dependent Patient with Resistant Hypertension? A Narrative Review.

PURPOSE OF REVIEW: This narrative review aims to assess the pathophysiology, diagnosis, and treatment of resistant hypertension (RH) in end-stage kidney disease (ESKD) patients on dialysis, with a specific focus on the effect of renal denervation (RDN) on short-term and long-term blood pressure (BP) control. Additionally, we share our experience with the use of RDN in an amyloidotic patient undergoing hemodialysis with RH. RECENT FINDINGS: High BP, an important modifiable cardiovascular risk factor, is often observed in patients in ESKD, despite the administration of multiple antihypertensive medications. However, in clinical practice, it remains challenging to identify RH patients on dialysis treatment because of the absence of specific definition for RH in this context. Moreover, the use of invasive approaches, such as RDN, to treat RH is limited by the exclusion of patients with reduced renal function (eGFR < 45 mL/min/1.73 m3) in the clinical trials. Nevertheless, recent studies have reported encouraging results regarding the effectiveness of RDN in stage 3 and 4 chronic kidney disease (CKD) and ESKD patients on dialysis, with reductions in BP of nearly up to 10 mmhg. Although multiple underlying pathophysiological mechanisms contribute to RH, the overactivation of the sympathetic nervous system in ESKD patients on dialysis plays a crucial role. The diagnosis of RH requires both confirmation of adherence to antihypertensive therapy and the presence of uncontrolled BP values by ambulatory BP monitoring or home BP monitoring. Treatment involves a combination of nonpharmacological approaches (such as dry weight reduction, sodium restriction, dialysate sodium concentration reduction, and exercise) and pharmacological treatments. A promising approach for managing of RH is based on catheter-based RDN, through radiofrequency, ultrasound, or alcohol infusion, directly targeting on sympathetic overactivity.

Feasibility, safety and long-term outcomes of complex left main bifurcation treatment using the nano-inverted-t stenting: a multicentre prospective registry.

The role of double stenting techniques in distal bifurcation left main (LM) disease has gaining interest over the latest years. We present the 3-year multicentre registry outcomes of dual stenting using ultra-thin strut stents and the Nano-Inverted-T (NIT) technique in complex unprotected true LM bifurcation disease. We analysed the procedural and medical data of consecutive patients enrolled between 1st January 2014 and 1st December 2019 in a multicentre registry for complex LM bifurcation disease treated with the double stenting technique called NIT due contraindications and/ or refusal to surgical treatment. Target lesion failure (TLF) was defined as the composite of cardiovascular death, target-vessel MI (TVMI) and clinically driven target lesion revascularization (TLR). Among two hundred-ninety-five patients (138 males, mean age 70.3 ± 12.8 years), post-operative success was achieved in 100% of cases. Contrast volume, procedural time, and radiation exposure were 139.2 ± 23.4 ml, 15.3 ± 4.9 min, and 1080 ± 1034 cGy/m2, respectively. At a mean follow-up of 39.5 ± 0.6 months TLF rate was 6.1% (n = 18) while TLR and cardiovascular mortality rates were 3.0 (n = 9) and 2.6% (n = 8), respectively. Clinically-driven angiographic follow-up was available in 26.4% of patients at a mean time from the procedure of 7.5 ± 0.4 months. Clinically restenosis rate was 3.3%.Revascularization of complex LM bifurcation disease using the NIT double stenting technique resulted feasible and safe with a low incidence of TLF, excellent survival rate and no stent thrombosis.

Ultrathin Biodegradable-Polymer Orsiro Drug-Eluting Stent Performance in Real Practice Challenging Settings.

BACKGROUND: The Orsiro cobalt-chromium stent platform (Biotronik, Bülach, Switzerland) is one of the first devices in the era of ultrathin struts. However, data regarding the efficacy of Orsiro stent in patients with challenging anatomical conditions obtained from daily clinical practice are scant. METHODS: We retrospectively reviewed the long-term outcomes, defined as target lesion revascularization (TLR), target vessel revascularization (TVR), stent thrombosis (ST) and cardiovascular (CV) mortality over a six years period, in 1161 consecutive patients (mean age 64.3 ± 11.2 years old, 681 males) treated with 2327 Orsiro stents in our institution who presented with challenging anatomic/angiographic features. RESULTS: The mean number of implanted stents was 1.7 ± 2.1 whereas the mean stent diameter and length were 3.6 ± 1.1 and 32.7 ± 15.6 mm, respectively. Mean follow-up duration was 35.6 ± 17 months (range 1-77 months); 923 patients (79.5%) reached the 3-year follow-up. The global rates of TLR, TVR, ST and CV mortality were 0.1%, 1.37%, 0.002%, and 1.9%, respectively with scarce statistically significant differences in multivessel disease, severe calcification, and lesion length > 41 mm. Multivariate regression analysis revealed that age, stent dislodgement, early stent thrombosis (p = 0.001) and lesion length ≥ 41 mm (p = 0.001) were independent predictors of TVR. Similarly, the occurrence of TLR was independently predicted by age, severe calcification, use of IVUS and Rotablator (p = 0.002), early stent thrombosis, LM bifurcation and length ≥ 41 mm (p = 0.001). CONCLUSIONS: The Orsiro stent confirmed a very high efficacy profile in all anatomical scenarios with very low rates of clinically driven TLR and TVR, CV mortality and ST at 3-years.

Impact of number of run-off vessels on interwoven nitinol mesh stents patency in the femoropopliteal segment.

OBJECTIVE: To evaluate the impact of run-off vessels number on the outcomes of Supera stent (Abbott Vascular, Santa Clara, Calif, USA) for treatment of femoropopliteal occlusive disease. METHODS: We retrospectively evaluated the medical records of 188 consecutive patients (mean age 68.2 ± 9.6 years, 100 males) undergone angiography and woven mesh stent implantation in femoral or popliteal arteries or both arterial segments, in our institution between January 1 2014 and January 1 2018. Target lesion revascularization and major adverse limb events at 12-month were evaluated comparing patients with 1-, 2- or 3-run-off vessels in the foot. RESULTS: Interventional success was achieved in 100%. Stent implantation involved in the femoral site in 56 patients (30.3%), the femoropopliteal in 92 patients (48.9%) and the popliteal site in 40 patients (21.3%). A significant improvement of ankle-brachial index (0.29 ± 0.6 vs. 0.88 ± 0.3, P < 0.001) and Rutherford class (5.3 ± 0.8 vs. 0.7 ± 1.9, P < 0.01) were observed before discharge. The median follow-up duration was 12.3 months (inter quartile range: 11.0 to 13.9). During the follow-up period, 52 patients (27.6%) had clinical events. Primary patency at 12 months was 72.4%. The primary patency significantly increased when the runoff status. Comparing the number of events among patients with different number of run-off vessels, a significant difference (P < 0.001) was observed for patients having one (24.0%) and two run-off vessels (15.0%). CONCLUSIONS: The outcomes of Supera stent in femoropopliteal occlusive disease depend strictly on the number of run-off vessels.

Risk of Dislodgement of Ultrathin Drug Eluting Stents Versus Thick Drug Eluting Stents.

Modern ultrathin struts drug eluting stents (DES), due to their constructive characteristics, might be more prone to stent dislodgment than the old thick DES. Our study is aimed to retrospectively analyze and compare the incidence and outcomes of stents dislodgment in thick (TSS) and ultrathin strut stents (USS).We retrospectively analyzed the procedural and medical data of 8,564 consecutive patients (mean age 64.3 ± 11.2 years old, 4442 males) who underwent percutaneous coronary intervention with DES implantation in our Institution between 1st January 2005 to 1st January 2020. Overall, 25,692 (mean of 3.2 stent for patients) have been implanted over the study period (10648 TSS and 15044 and USS, respectively). Stent dislodgment globally occurred in 0.56% of the implanted stents (0.28% vs 0.78%, p <0.001 for TTS and USS, respectively). Coronary artery calcifications, ostial lesion, coronary artery tortuosity, and a lesion length >25 mm were independent predictors of type I and II USS dislodgments. At 12 months follow up, the rate of target lesion failure was higher in the TTS group (30.7 vs 12.7 %, p <0.001). Stent dislodgement is unusual in the modern era but is more frequent using USS than TTS DES.

Light anti-thrombotic regimen for prevention of device thrombosis and/or thrombotic complications after interatrial shunts device-based closure.

AIMS: The optimal antiplatelet therapy after atrial septal defect (ASD) or patent foramen ovale device closure (PFO) remain to be established. We evaluated the safety and effectiveness of 6-month 100 mg Aspirin (ASA) regimen in the very long-term follow up after intracardiac echocardiography (ICE) -aided interatrial shunt closure in a large retrospective cohort. METHODS: Single-center retrospective analysis which included medical and instrumental data of 789 consecutive patients referred to our institution over a 15 years period due interatrial shunt catheter-based closure. RESULTS: Finally, 734 patients were included in the analysis (mean age 46.1 ± 14.6 years, 398 females): ASD and PFO closure were successfully performed in 281 and 453 patients, respectively. Over the follow-up period, no major bleeding events were observed while the rate of minor bleeding events was 0.9%. Tolerance problems were detected in 3.4% of cases (n==28). In 11 patients (1.5%) an abnormal complete blood count was detected and monitored up to normalization. On a mean follow -up of 10.3 ± 3.0 years (range 1-15), 10 patients (1.36%) had a persistent moderate shunt 12 months after closure and maintained Aspirin 100 mg life-long, whereas the remaining 724 suspended the treatment after 6 months. Device thrombosis in ASD and PFO groups were 0% and 0.2%, respectively. A cerebral ischemic event occurred in 0.4% of the entire cohort. CONCLUSIONS: A regimen of 100 mg of ASA for six months after ASD/PFO closure appeared to be both safe and effective in preventing device thrombosis and major bleedings.

Long-Term Outcomes of Left Main Bifurcation Double Stenting in Patients with STEMI and Cardiogenic Shock.

The contribution of different left main (LM) bifurcation stenting techniques on long-term CV mortality has been poorly investigated. We evaluated the 3-year outcomes of revascularization of unprotected complex bifurcation LM in patients with cardiogenic shock (CS) with LM bifurcation/distal disease as culprit lesion. We analyzed 752 consecutive patients with STEMI admitted to our centre from 1 January 2014 to 1 March 2018, searching for patients with CS and complex distal/bifurcation LM disease as culprit lesion who received, at operators' discretion, LM double stenting by means of Culotte, T-stenting/TAP or Nano-crush technique. Fifty-seven patients (23 females, mean age 62.3 ±â€¯10.5 years) with CS and STEMI with distal/bifurcation LM as culprit lesion were identified: 20 patients (35.0%) received Culotte, 16 patients (28.0%) received T-stenting/TAP and 20 (35.0%) received Nano-crush technique. At 3-year follow-up, clinical-driven target lesion revascularization, and mortality rate for all-causes were comparable among different stenting techniques. Conversely, considering 3-year CV mortality as outcome, a statistically significant difference was observed favoring Nano-crush when compared to patients treated with T stenting. Nano-crush obtained a larger improvement of ejection fraction on serial echocardiograms. CS with complex distal/bifurcation LM disease can be treated with acceptable rate of complication and short-term mortality using double stenting techniques. Techniques that minimize rewiring and kissing steps and shorten ischemic time should probably be preferred.

Non-invasive Evaluation of Fluid Dynamic of Aortoiliac Atherosclerotic Disease: Impact of Bifurcation Angle and Different Stent Configurations.

OBJECTIVES: To non-invasively evaluate by computational fluid dynamic (CFD) analysis the physiology and rheology of aortoiliac bifurcation disease at different angles and different stent configurations. MATERIAL AND METHODS: For the analysis, we considered a physiologic model of abdominal aorta with an iliac bifurcation set at 30°, 45° and 70° without stenosis. Subsequently, a bilateral ostial common iliac stenosis of 80% was considered for each type of bifurcation. For the stent simulation, we reconstructed Zilver vascular self-expanding (Zilver; Cook, Bloomington, MN) and Palmaz Genesis Peripheral (Cordis, Miami, FL) stents. RESULTS: The physiologic model, across the different angles, static pressure, Reynolds number and stream function, were lower for the 30° bifurcation angle with a gradient from 70° to 30° angles, whereas all the other parameters were inversely higher. After stenting, all the fluid parameters decreased homogenously independent of the stent type, maintaining a gradient in favour of 30° compared to 45° and 70° angles. The absolute greater deviation from physiology was observed for low kissing when self-expandable stents were used across all angles; in particular, the wall shear stress was high at at 45° angle. CONCLUSION: Bifurcation angle deeply impacts the physiology of aortoiliac bifurcations, which are used to predict the fluid dynamic profile after stenting. CFD, having the potential to be derived both from computed tomography scan or invasive angiography, appears to be an ideal tool to predict fluid dynamic profile before and after stenting in aortoiliac bifurcation.

Rheolytic effects of left main mid-shaft/distal stenting: a computational flow dynamic analysis.

Background The aim of this study was to evaluate the rheolytic effects of stenting a mid-shaft/distal left main coronary artery (LMCA) lesion with and without ostial coverage. Stenting of the LMCA has emerged as a valid alternative in place of traditional coronary bypass graft surgery. However, in case of mid-shaft/distal lesion, there is no consensus regarding the extension of the strut coverage up to the ostium or to stent only the culprit lesion. Methods We reconstructed a left main-left descending coronary artery (LM-LCA)-left circumflex (LCX) bifurcation after analysing 100 consecutive patients (mean age 71.4 ± 9.3, 49 males) with LM mid-shaft/distal disease. The mean diameter of proximal LM, left anterior descending (LAD) and LCX, evaluated with quantitative coronary angiography (QCA) was 4.62 ± 0.86 mm, 3.31 ± 0.92 mm, and 2.74 ± 0.93 mm, respectively. For the stent simulation, a third-generation, everolimus-eluting stent was virtually reconstructed. Results After virtual stenting, the net area averaged wall shear stress (WSS) of the model and the WSS at the LCA-LCX bifurcation resulted higher when the stent covered the culprit mid-shaft lesion only compared with the extension of the stent covering the ostium (3.68 versus 2.06 Pa, p = 0.01 and 3.97 versus 1.98 Pa, p < 0.001, respectively. Similarly, the static pressure and the Reynolds number were significantly higher after stent implantation covering up the ostium. At the ostium, the flow resulted more laminar when stenting only the mid-shaft lesion than including the ostium. Conclusions Although these findings cannot be translated directly into real practice our brief study suggests that stenting lesion 1:1 or extending the stent to cover the LM ostium impacts differently the rheolytic properties of LMCA bifurcation with potential insights for restenosis or thrombosis.

Complex coronary bifurcation treatment by a novel stenting technique: Bench test, fluid dynamic study and clinical outcomes.

OBJECTIVES: We assess the mid-term outcomes of ultrathin biodegradable polymer double stenting using a very minimal crushing (Nano-Crush) technique in large complex coronary bifurcation. BACKGROUND: Complex bifurcations have been suggested to be better approached by a planned double stent technique. METHODS: Two hundred and five consecutive patients (107 males and 98 females) referred for large complex coronary bifurcation percutaneous coronary interventions were enrolled. The technique was also evaluated by both a bench test with a silicon tubes phantom resembling a coronary bifurcation and a computed fluid dynamic (CFD) analysis. RESULTS: Left main bifurcation accounted for 40.9% of cases (84 patients). Mean angles between main branch (MB) and side branch (SB) were 63.6 ± 21.3°. SB intravascular ultrasound-calculated MSA was 5.6 ± 1.5 mm2 . Clinical follow-up was available for 100% of patients and at a mean follow-up of 16.2 ± 6.7 months 8 deaths, all due to cardiovascular reason, (3.9%, 4 patients for stroke, two for heart failure, one after surgical aortic valve substitution, and one after acute massive pulmonary embolism) and no presumptive stent thrombosis or target vessel induced ischemia were observed. Angiographic follow-up was available in 108 patients (52.7%) and showed a very low significant restenosis (5 patients, 4.6%). Bench study and CFD evaluation suggested a complete coverage of the SB ostium with a very high strut-free area at the SB. CONCLUSIONS: The revascularization of complex large coronary bifurcation disease using the Nano-crush technique appeared promising thanks to the favorable fluid dynamic profile, complete coverage of the SD ostium, and very small metal amount at the carina.

Characterization of single vs. recurrent spontaneous coronary artery dissection.

Background Spontaneous coronary artery dissection is a rare non-atherosclerotic cause of acute coronary syndromes, often underdiagnosed based on standard coronary angiography. Moreover, features, presentation, and intravascular imaging of recurrent spontaneous dissections have not been assessed. Methods Patients with recurrent spontaneous coronary artery dissection, who were admitted to our catheterization laboratory over a 10-year period, were identified. Demographic, clinical, angiographic, and intravascular imaging data were reviewed and analyzed, comparing patients with a single event with those who had a recurrence. Results Over the study period, 31 (0.2%, mean age 48.1 ± 8.8 years, 24 females) of 10,954 patients who underwent coronary angiography experienced a single spontaneous coronary artery dissection, and 6 (0.05%, mean age 49.3 ± 10.1 years, 4 females) experienced recurrent spontaneous coronary artery dissection. No patient suffered more than 2 dissections. Arterial hypertension ( p = 0.004), a string sign measuring >15 mm on angiography, and hematoma on intravascular ultrasound imaging were more frequently observed in patients with recurrent spontaneous coronary artery dissection. Conclusions Hypertension, length of the string sign on angiography, and hematoma on intravascular ultrasound imaging might identify patients at higher risk of recurrent spontaneous coronary artery dissection despite a lifelong dual antiplatelet regimen.

Evaluation of potential substrates for restenosis and thrombosis in overlapped versus edge-to-edge juxtaposed bioabsorbable scaffolds: Insights from a computed fluid dynamic study.

BACKGROUND/PURPOSE: Multiple BRSs and specifically the Absorb scaffold (BVS) (Abbott Vascular, Santa Clara, CA USA) have been often used to treat long diffuse coronary artery lesions. We evaluate by a computational fluid dynamic(CFD) study the impact on the intravascular fluid rheology on multiple bioabsorbable scaffolds (BRS) by standard overlapping versus edge-to-edge technique. METHODS/MATERIALS: We simulated the treatment of a real long significant coronary lesion (>70% luminal narrowing) involving the left anterior descending artery (LAD) treated with a standard or edge-to-edge technique, respectively. Simulations were performed after BVS implantations in two different conditions: 1) Edge-to-edge technique, where the scaffolds are kissed but not overlapped resulting in a luminal encroachment of 0.015cm (150µm); 2) Standard overlapping, where the scaffolds are overlapped resulting in a luminal encroachment of 0.030cm (300µm). After positioning the BVS across the long lesion, the implantation procedure was performed in-silico following all the usual procedural steps. RESULTS: Analysis of the wall shear stress (WSS) suggested that at the vessel wall level the WSS were lower in the overlapping zones overlapping compared to the edge-to-edge zone (∆=0.061Pa, p=0.01). At the struts level the difference between the two WSS was more striking (∆=1.065e-004 p=0.01) favouring the edge-to-edge zone. CONCLUSIONS: Our study suggested that at both vessel wall and scaffold struts levels, there was lowering WSS when multiple BVS were implanted with the standard overlapping technique compared to the "edge-to-edge" technique. This lower WSS might represent a substrate for restenosis, early and late BVS thrombosis, potentially explaining at least in part the recent evidences of devices poor performance.

Ketamine and midazolam differently impact post-intubation hemodynamic profile when used as induction agents during emergency airway management in hemodynamically stable patients with ST elevation myocardial infarction.

We investigated the incidence of post-intubation hypotension (PIH) in hemodynamically stable patients with STEMI requiring rapid sequences intubation (RSI) and medicated with ketamine or midazolam as induction agent. STEMI patients admitted between 1st January 2009 and 1st January 2017 who did not receive any type of inotropic support before the endotracheal intubation (ETI) was reviewed. PIH was defined as a reduction greater than 20% or a drop of systolic blood pressure (SBP) below 90 mmHg within 10 min from the administration of the induction agent [ketamine (1 mg/kg) or midazolam (0.3 mg/kg)]. Over the study period, 136 patients (66 male and 70 females, mean age 72.25 ± 7.33 years) met the inclusion criteria. Patients treated with midazolam and ketamine were 63 and 73, respectively. PIH was observed in 38 (27.9%) patients after 10 min from ETI. Midazolam patients had a significant lower SBP at both 5 and 10 min after induction (97.75 ± 8.06 vs 100.81 ± 8.08, p = 0.029 and 92.83 ± 7.53 vs 101.58 ± 7.29, p < 0.0001, respectively) (ANOVA p < 0.0001). Age (OR 1.91, 95% CI 1.87-1.97, p = 0.001), history of arterial hypertension (OR 2.27, 95% CI 2.21-2.35, p = 0.0001), multivessel coronary artery disease (OR 2.66, 95% CI 2.58-2.71, p = 0.001), SI ≥0.9 (OR 2.41, 95% CI 2.36-2.48, p < 0.0001) and anterior STEMI (OR 2.51, 95% CI 2.48-2.57, p = 0.0001) resulted independent predictors of PIH in STEMI patients treated with midazolam, as induction agent, before ETI. Midazolam was more likely than ketamine to cause significant PIH when used as an induction agent for RSI in hemodynamically stable patients with STEMI.

Modified balloon aortic valvuloplasty in fragile symptomatic patients unsuitable for both surgical and percutaneous valve replacement.

BACKGROUND: Balloon Aortic valvuloplasty (BAV) is considered as a bridge therapy to percutaneous valve implantation or a palliative treatment in patients with aortic valve stenosis (AVS). Potential risk of complications, in particular in fragile patients, is still not negligible. AIM: To describe the technique and outcomes of modified BAV in fragile symptomatic patients unsuitable for other treatments using no-pacing and minimally invasive approach. METHODS: Symptomatic fragile patients with severe aortic valve stenosis judged unsuitable by the heart team for surgical or percutaneous valve implantation from 1 September 2013 to 1 September 2017 were offered modified BAV. Simplified procedural protocol included a 4F right radial artery access for gradient check, a 8F compatible undersized balloons, two partial inflations-trial before a full inflation with no-pace maker back-up, final pressure gradient recording and aortography. RESULTS: Thirty-four symptomatic fragile patients (mean age 80.9±4.9, range 73 to 91years, 100% Katz >6, mean Euroscore I 30.0±11.7%) underwent modified BAV in the last 5years with immediate success in all (100%). Mean aortic valve area increased from 0.58±0.2cm2 to 1.1±0.2cm2 (p<0.01) whereas mean peak gradient decreased from 75.6±11.3 to 35.8±11.2mmHg (p<0.01). Procedural complications were 14.7%. Thirty-day mortality was 11.8%. On a mean follow up of 38.4±4.6months four patients successfully repeated the procedure, while global mortality was 23.5% (8 patients). The other 22 patients maintained a NYHA class of 2.1±0.7. CONCLUSIONS: No-pacing minimally invasive BAV seems to have acceptable outcomes in patients with severe AVS and no other treatment options.

Hybrid metal/scaffold-jacket versus full-metal jackets in left anterior descending coronary artery diffuse disease: Differences in radiation exposure and fluoroscopic/procedural times.

BACKGROUND/PURPOSE: Bioabsorbable vascular scaffolds (BVS) are made from a radiolucent material. Their multiple implantations on a single long diffused segment requires a specific technique with imaging magnification, which could cause an increase in dose delivered during percutaneous coronary intervention (PCI) procedure. We aimed to identify differences in radiation dose, fluoroscopy and procedural times in Hybrid DES+ multiple BVS (Absorb, Abbott Inc., USA) implantation (hybrid metal/scaffold jacket) versus multiple III generation Drug-eluting stents (DES) (full-metal jacket) in patients with long and diffuse coronary artery disease of the left anterior descending (LAD) coronary artery. METHODS/MATERIALS: Patients with long and diffuse LAD disease were enrolled in a registry from 1st February 2015 to 1st February 2017. Patients treated with hybrid DES/BVS (at least three) jacket (n=72 procedure) were compared with a 2:1 matched cohort of exclusive multiple overlapped DES (full-metal jacket) patients in the same period (n=114 procedures). RESULTS: Patients had similar baseline characteristics due to matching. Radiation exposure (6035.7±2846.8 vs 4251.1±1787.3cGy∗cm2, p<0.0001, Δ=1784.5±1055.6), fluoroscopy time (16.2±4.5 vs 9.1±2.4, p<0.0001) and procedure time (64.2±18.5 vs 5 8.7±13.5, p=0.02) were higher in patients treated using hybrid metal/scaffold jacket compared that regular full-metal jacket. CONCLUSION: The use of hybrid metal/scaffold jacket for the treatment of long and diffuse disease of LAD is associated with a higher fluoroscopy time and radiation exposure compared to full-metal jacket, quantifiable in approximately 35%.