Efficacy of intravascular lithotripsy (IVL) in coronary stenosis with severe calcification: A multicenter systematic review and meta-analysis.

BACKGROUND: With heavily calcified coronary and peripheral artery lesions, lesion preparation is crucial before stent placement to avoid underexpansion, associated with stent thrombosis or restenosis and patency failure in the long-term. Intravascular lithotripsy (IVL) technology disrupts superficial and deep calcium by using localized pulsative sonic pressure waves, making it to a promising tool for patients with severe calcification in coronary bed. AIMS: The aim of the study is to systematically review and summarize available data regarding the safety and efficacy of IVL for lesion preparation in severely calcified coronary arteries before stenting. METHODS: This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 23, 2023, for studies assessing the characteristics and outcomes of patients undergoing IVL before stent implantation. The diameter of the vessel lumen before and after IVL, as well as stent implantation, were analyzed. The occurrence of major adverse cardiovascular events (MACE) was assessed using a random-effects model. RESULTS: This meta-analysis comprised 38 studies including 2977 patients with heavily calcified coronary lesions. The mean age was 72.2 ± 9.1 years, with an overall IVL clinical success of 93% (95% confidence interval [CI]: 91%-95%, I2 = 0%) and procedural success rate of 97% (95% CI: 95%-98%, I2 = 73.7%), while the in-hospital and 30-days incidence of MACE, myocardial infarction (MI), and death were 8% (95% CI: 6%-11%, I2 = 84.5%), 5% (95% CI: 2%-8%, I2 = 85.6%), and 2% (95% CI: 1%-3%, I2 = 69.3%), respectively. There was a significant increase in the vessel diameter (standardized mean difference [SMD]: 2.47, 95% CI: 1.77-3.17, I2 = 96%) and a decrease in diameter stenosis (SMD: -3.44, 95% CI: -4.36 to -2.52, I2 = 97.5%) immediately after IVL application, while it was observed further reduction in diameter stenosis (SMD: -6.57, 95% CI: -7.43 to -5.72, I2 = 95.8%) and increase in the vessel diameter (SMD: 4.37, 95% CI: 3.63-5.12, I2 = 96.7%) and the calculated lumen area (SMD: 3.23, 95% CI: 2.10-4.37, I2 = 98%), after stent implantation. The mean acute luminal gain following IVL and stent implantation was estimated to be 1.27 ± 0.6 and 1.94 ± 1.1 mm, respectively. Periprocedural complications were rare, with just a few cases of perforations, dissection, or no-reflow phenomena recorded. CONCLUSIONS: IVL seems to be a safe and effective strategy for lesion preparation in severely calcified lesions before stent implantation in coronary arteries. Future prospective studies are now warranted to compare IVL to other lesion preparation strategies.

Retrospective Case Control Matched Comparison of the Antegrade Versus Retrograde Strategy After Antegrade Recanalisation Failure in Complex de novo Femoropopliteal Occlusive Lesions.

OBJECTIVE: To investigate dissection severity, need for bailout stenting and limb outcomes in patients undergoing antegrade vs. retrograde revascularisation. METHODS: Consecutive patients who underwent either antegrade or retrograde revascularisation after failed antegrade recanalisation of long femoropopliteal chronic total occlusion (CTO) due to symptomatic peripheral artery disease between January 2017 and June 2022 were studied. Retrospective case control matching was used to adjust for lesion length and calcification using the peripheral artery calcification scoring system (PACSS). Procedural outcomes included severity of dissection (Type A to F dissections, numerically graded on a scale from 0 - 6 with increasing severity) after angioplasty and number and location of stents needed to be implanted during the index procedure. Additionally, clinically driven target lesion revascularisation (CD-TLR) and major (above ankle) amputation rates were assessed during follow up. RESULTS: A total of 180 patients were analysed who underwent antegrade (n = 90) or retrograde after failed antegrade (n = 90) recanalisation. The median patient age was 76.0 (interquartile range [IQR] 67.0, 82.0) years and 76 (42.2%) were female. Moreover, 78 patients (43.3%) had intermittent claudication, whereas 102 (56.7%) had chronic limb threatening ischaemia (CLTI). The mean lesion length was 30.0 (IQR 24.0, 36.0) cm with moderate to severe (3.0 [IQR 2.0, 4.0]) lesion calcification. Dissection severity after angioplasty was higher in the antegrade than retrograde after failed antegrade recanalisation group (4.0 [IQR 3.0, 4.0] vs. 3.0 [IQR 2.0, 4.0]; p < .001). Additionally, the number of stents in all segments and the rate of bailout stenting in popliteal segments was significantly higher with the antegrade strategy (2.0 [IQR 1.0, 3.0] vs. 1.0 [IQR 0, 2.0], p < .010; and 37% vs. 14%, p < .001). During a median follow up of 1.48 (IQR 0.63, 3.09) years, CD-TLR rates (p = .90) and amputation rates in patients with CLTI (p = .15) were not statistically significant. CONCLUSION: In complex femoropopliteal CTOs, retrograde after failed antegrade recanalisation, is safe for endovascular revascularisation, which in experienced hands may result in less severe dissections and lower rates of stent placement. However, considering the relatively short follow up, CD-TLR and amputation rates were not statistically different between the two approaches. [German Clinical Trials Register: DRKS00015277.].

Safety and effectiveness of the phoenix atherectomy device for endovascular treatment of common femoral and popliteal arteries: Results of the EN-MOBILE trial.

Background: This study aimed to assess the peri- and postprocedural outcomes of atherectomy-assisted endovascular treatment of the common femoral (CFA) and popliteal arteries. Methods: Phoenix atherectomy was used for the treatment of 73 and 53 de novo CFA and popliteal artery lesions, respectively, in 122 consecutive patients. Safety endpoints encompassed perforation and peripheral embolization. Postprocedural endpoints included freedom from clinically driven target lesion revascularization (CD-TLR) and clinical success (an improvement of ⩾ 2 Rutherford category [RC]). In addition, 531 patients treated for popliteal artery stenosis or occlusion without atherectomy were used as a comparator group. Results: Procedural success (residual stenosis < 30% after treatment) was 99.2%. The need for bail-out stenting was 2 (2.7%) and 3 (5.7%) in CFA and popliteal artery lesions, respectively. Only one (1.4%) embolization occurred in the CFA, which was treated by catheter aspiration. No perforations occurred. After 1.50 (IQR = 1.17-2.20) years, CD-TLR occurred in seven (9.2%) and six (14.6%) patients with CFA and popliteal artery lesions, respectively, whereas clinical success was achieved in 62 (91.2%) and 31 (75.6%), respectively. Patients treated with atherectomy and DCB in the popliteal artery after matching for baseline RC, lesion calcification, length, and the presence of chronic total occlusion, exhibited higher freedom from CD-TLR compared to the nondebulking group (HR = 3.1; 95% CI = 1.1-8.5, p = 0.03). Conclusion: Atherectomy can be used safely and is associated with low rates of bail-out stenting in CFA and popliteal arteries. CD-TLR and clinical success rates are clinically acceptable. In addition, for the popliteal artery, atherectomy combined with DCB demonstrates lower CD-TLR rates compared to a DCB alone strategy. (German Clinical Trials Register: DRKS00016708).

Intravascular lithotripsy in peripheral lesions with severe calcification and its use in TAVI procedure - a meta-analysis.

Background: Heavily calcified peripheral artery lesions increase the risk of vascular complications, constituting a severe challenge for the operator during catheter-based cardiovascular interventions. Intravascular Lithotripsy (IVL) technology disrupts subendothelial calcification by using localized pulsative sonic pressure waves and represents a promising technique for plaque modification in patients with severe calcification in peripheral arteries. Purpose: Our aim was to systematically review and summarize available data regarding the safety and efficacy of IVL in preparing severely calcified peripheral arteries and its use in Transcatheter Aortic Valve Implantation (TAVI). Patients and methods: This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 23, 2023, for studies assessing the characteristics and outcomes of patients undergoing IVL in the peripheral vasculature. The diameter of the vessel lumen before and after IVL was estimated. The occurrence of peri-procedural complications was assessed using a random-effects model. Results: 20 studies with a total of 1,223 patients with heavily calcified peripheral lesions were analysed. The mean age of the cohort was 70.6 ± 17.4 years. Successful IVL delivery achieved in 100% (95% CI: 100%-100%, I2 = 0%), with an increase in the luminal diameter (SMD: 4.66, 95% CI: 3.41-5.92, I2 = 90.8%) and reduction in diameter stenosis (SMD: -4.15, 95% CI: -4.75 to -3.55, I2 = 92.8%), and a concomitant low rate of complications. The procedure was free from dissection in 97% (95% CI: 91%-100%, I2 = 81.4%) while dissections of any type (A, B, C, or D) were observed in 6% (95% CI: 2%-10%, I2 = 85.3%) of the patients. Several rare cases of abrupt closure, no-reflow phenomenon, perforation, thrombus formation, and distal embolization were recorded. Finally, the subgroup analysis of patients who underwent a TAVI with IVL assistance presented successful implantation in 100% (95% CI: 100%-100%, I2 = 0%) of the cases, with only 4% (95% CI: 0%-12%, I2 = 68.96%) presenting dissections of any sort. Conclusions: IVL seems to be an effective and safe technique for modifying severely calcified lesions in peripheral arteries and it is a promising modality in TAVI settings. Future prospective studies are needed to validate our results.

Novel Therapeutic Concepts for Complex Femoropopliteal Lesions Using the Jetstream Atherectomy System.

INTRODUCTION: The presence of severe arterial calcification is associated with less favorable outcomes in terms of procedural and clinical success as well as higher rates of major adverse limb events. Recent studies incorporating rotational atherectomy for effective preparation of severely calcified lesions demonstrate beneficial procedural outcomes by obtaining maximal luminal gain and improved long-term outcomes. METHODS: This prospective single-center, observational study includes patients with severely calcified femoropopliteal lesions with chronic limb ischemia Rutherford 1-5 between January 2017 and July 2019, who underwent atherectomy using the Jetstream Atherectomy system, followed by drug-coated balloon angioplasty. Lesion calcification was categorized by the Peripheral Arterial Calcium Scoring System (PACSS), whereas lesion complexity was classified by the Transatlantic Inter-Society Consensus (TASC). Safety and efficacy aspects in terms of vessel injury, thromboembolism, and clinical success were systematically analyzed up to 12 months of follow-up (FU). RESULTS: In 162 consecutive patients, 210 non-stented and 22 stented lesions were treated. Twelve (7.4%) patients received bail-out stenting. Mean lesion length was 24.2±4.8 cm; 51% were chronic total occlusions (mean occlusion length 18.2±5.1 cm). TASC C lesions were present in 38 patients (23.5%) and TASC D lesions in 124 patients (76.5%). The mean PACCS score was 3.3±0.9. Device success was achieved in 88%; procedural success was noted in 99% of the lesions. Embolic protection device was used in 11.7%. Perforation or dissection occurred in none of the cases. Asymptomatic peripheral embolization was noted in 10 patients (6.2%). Clinical FU at 12 months was available in 157 of 162 patients (96.9%). At 12 month FU, (1) mean Rutherford classification at baseline of 3.7±0.6 significantly dropped to 1.0±0.9 (p<0.05), (2) baseline mean anke-brachial index (ABI) of 0.4±0.1 significantly increased to 0.8±0.2 (p<0.05), (3) 92.6% were free from target lesion revascularization (TLR), (4) 95.1% were free from target vessel revascularization (TVR), and (5) binary restenosis measured by duplex occurred in 22 patients (13.6%). Multivariate analyses showed lesion length as predictive of stent placement (p=0.02), whereas both lesion length (p=0.006) and PACCS score (p=0.02) are predictive of clinical success. CONCLUSION: Rotational atherectomy in combination with drug-coated balloon (DCB) can be safely performed in long, calcified (non-) occlusive lesions with a relatively low rate of bail-out stenting and favorable clinical mid-term results. CLINICAL IMPACT: In this prospective, single arm study we demonstrated that combination treatment using rotational atherectomy and DCB is safe and effective in complex and calcified TASC C/D femoropopliteal lesions in patients with claudication or CLTI in a real-world clinical setting. Despite mean lesion length of >20cm and a relatively high rate of chronic total occlusions, the rate of bail-out stenting was surprisingly low (7.4%), whereas the rates of freedom from TLR and TVR were surprisingly high. Thus, our study may encourage vascular specialists to choose an endovascular -first approach even in such complex and calcified femoropopliteal lesions and occlusions in daily clinical practice.

Endovascular Versus Surgical Treatment for All Comer Patients With Prosthetic Bypass Graft Occlusion: The Multicentre ENSUPRO Study.

OBJECTIVE: Bypass surgery plays a key role in complex lower limb lesions. However, there is a lack of evidence regarding the management of symptomatic prosthetic bypass graft (PBG) occlusion. This study aimed to report outcomes following open, hybrid, or endovascular management of patients presenting with symptomatic PBG occlusion. METHODS: A multicentre, retrospective cohort study was conducted, including patients presenting with PBG occlusion between January 2014 and December 2021 from 18 centres. It assessed the comparative value of treatment strategies, including (1) recanalisation of native vessels, (2) endovascular treatment of the failed PBG, (3) hybrid treatment, and (4) open surgery. The primary outcome measure was amputation free survival (AFS, time to major amputation and or death), whereas all cause mortality, major amputation, PBG re-occlusion, target lesion revascularisation (TLR), and Rutherford category (RC) improvement during follow up were considered as secondary endpoints. RESULTS: Of 260 patients with occluded PBGs, 108 (41.5%) were treated endovascularly (24 [22.2%] by recanalisation of native vessels and 84 [77.7%] by PBG re-opening), 57 (21.9%) underwent hybrid revascularisation, and 58 (22.3%) had surgery. In addition, 27 (10.4%) were treated conservatively and 10 (3.8%) received systemic thrombolysis. With a median follow up of 1.4 (0.6 - 3.0) years, AFS was 95.5%, 76.4%, 45.5%, and 37.1%, respectively in Groups 1 - 4 (p = .007). Older age and non-endovascular treatment (HR 1.05 and 1.70; p < .01 for both) were independent predictors of poor AFS. Endovascular treatment was associated with lower rates of major amputation (p = .04), PBG re-occlusion (p < .001), and TLR (p = .037), and higher RC improvements (p < .001), whereas all cause mortality was comparable between treatment groups (p = .21). CONCLUSION: Endovascular treatment is associated with higher rates of AFS and RC improvement and lower rates of PBG re-occlusion and TLR in patients with PBG occlusion.

Best crossing of peripheral chronic total occlusions.

Together with colleagues from different disciplines, including cardiologists, interventional radiologists and vascular surgeons, committee members of the of the German Society of Angiology (Deutsche Gesellschaft für Angiologie [DGA]), developed a novel algorithm for the endovascular treatment of peripheral chronic total occlusive lesions (CTOs). Our aim is to improve patient and limb related outcomes, by increasing the success rate of endovascular procedures. This can be achieved by adherence to the proposed crossing algorithm, aiding the standardization of endovascular procedures. The following steps are proposed: (i) APPLY Duplex sonography and if required 3D techniques such as computed tomography or magnetic resonance angiography. This will help you to select the optimal access site. (ii) EVALUATE the CTO cap morphology and distal vessel refilling sites during diagnostic angiography, which are potential targets for a retrograde access. (iii) START with antegrade wiring strategies including guidewire (GW) and support catheter technology. Use GW escalation strategies to penetrate the proximal cap of the CTO, which may usually be fibrotic and calcified. (iv) STOP the antegrade attempt depending on patient specific parameters and the presence of retrograde options, as evaluated by pre-procedural imaging and during angiography. (v) In case of FAILURE, consider advanced bidirectional techniques and reentry devices. (vi) In case of SUCCESS, externalize the GW and treat the CTO. Manage the retrograde access at the end of the endovascular procedure. (vii) STOP the procedure if no progress can be obtained within 3 hours, in case of specific complications or when reaching maximum contrast administration based on individual patient's renal function. Consider radiation exposure both for patients and operators. In this manuscript we systematically follow and explain each of the steps (i)-(vi) based on practical examples from our daily routine. We strongly believe that the integration of this algorithm in the daily practice of endovascular specialists, can improve vessel and patient specific outcomes.

Endovascular interventions in outpatient care.

Endovascular arterial revascularisations for the treatment of symptomatic peripheral arterial disease are constantly increasing in importance and number due to the changing age structure and high numbers of comorbidities in the German population. Patients with peripheral artery disease are often at increased risk for peri- and post-procedural complications including severe cardiovascular events. Due to limited financial and human resources and considerable risks of hospitalization, endovascular interventions that were previously reserved for hospitalized patients are now progressively considered to be performed as day case procedures. More than one third of these procedures are performed in Germany by internists with a specialization in angiology. In the current position paper the German Society of Angiology endorsed by the European Society of Vascular Medicine, summarizes the requirements and risk factors to be considered for the planning, safe performance and post procedural care of endovascular revascularizations in outpatients. The performance of endovascular procedures for peripheral artery disease both in hospitalised and outpatients should be accompanied by a mandatory quality assurance process that should not only capture procedural data, but also require documentation of complications and longterm outcome.

Retrograde use of the Outback re-entry catheter in complex infrainguinal arterial recanalizations.

OBJECTIVE/BACKGROUND: Retrograde recanalizations gained increasing recognition in complex arterial occlusive disease. Re-entry devices are a well-described adjunct for antegrade recanalizations. We present our experience with retrograde, infrainguinal recanalizations using the Outback re-entry catheter in challenging chronic total occlusions. METHODS: We report data from a retrospective multicenter registry in complex retrograde recanalizations. Eligibility criteria included retrograde infrainguinal use of the Outback re-entry catheter where both conventional antegrade and retrograde recanalizations had been unsuccessful. Procedural outcomes included technical success (defined as successful wire passage and delivery of adjunctive therapy with <30% residual stenosis), safety (periprocedural complications, eg, bleeding, vessel injury, or occlusion of the artery at the re-entry site, and distal embolizations), and clinical outcome (amputation-free survival and freedom from clinically driven target lesion revascularization [cd-TLR]). RESULTS: Forty-five consecutive patients underwent retrograde, infrainguinal recanalization attempts with the Outback re-entry catheter between February 2015 and August 2020. Thirty (67%) patients had a history of open vascular surgery in the index limb. In four patients, recanalizations were even more challenging due to previous surgical removal and/or ligation of the proximal segment of the superficial femoral artery. The retrograde access site of the Outback catheter was the femoropopliteal segment in 31 (69%) patients and crural vessels in 14 (31%) patients. The re-entry target sites were as follows: common femoral artery in 31 (69%) patients, superficial femoral artery in 9 (20%) patients, popliteal artery in 1 patient, and below-the-knee arteries in 2 patients. In four patients, the needle of the re-entry device was targeted to an inflated balloon, inserted via the antegrade route. The Outback re-entry catheter was placed via a 6-French sheath in 19 (42%) cases and sheathless in 26 (58%) cases. Technical success was achieved in 41 (91%) patients There were two instances of distal embolizations and three bleeding episodes. Amputation-free survival was 100% at 30 days, and after 12 months, freedom from cd-TLR was 95% at 30 days and 75% at 12 months of follow-up. Female sex was an independent predictor for cd-TLR at 12 months of follow-up. CONCLUSIONS: Retrograde use of the Outback re-entry catheter in infrainguinal chronic total occlusions provides an effective and safe endovascular adjunct, when conventional antegrade and retrograde recanalization attempts have failed.

A Systematic Review and Meta-Analysis on the Efficacy and Safety of Direct Oral Anticoagulants in Patients with Peripheral Artery Disease.

BACKGROUND: PAD is a significant cause of morbidity and mortality affecting over 200 million people worldwide. Current guidelines recommend at least a single antiplatelet or anticoagulant agent in symptomatic PAD and lifelong antithrombotic treatment after a revascularization procedure. The aim of this systematic review and meta-analysis was to investigate the efficacy and safety of direct oral anticoagulants (DOACs) in patients with peripheral artery disease (PAD). PAD is a significant cause of morbidity and mortality affecting over 200 million people worldwide. METHODS: The present systematic review and meta-analysis was performed according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Risk ratios (RR) were calculated using the random effects model. RESULTS: Overall, 10 studies were included in this systematic review and meta-analysis. In 4 studies, 14,257 patients with PAD were enrolled and they were assigned to receive either aspirin (ASA)+/- clopidogrel (N = 5,894) or DOAC+/- anti-platelet (e.g., ASA, clopidogrel) (n = 8,363). Non DOAC users were found to have higher reintervention rates (RR 1.12; 95% CI 1.01-1.24; P = 0.025) compared to DOAC users. No statistically significant difference was observed between the 2 groups, in terms of major bleeding (RR 0.78; 95% CI 0.50-1.23; P = 0.285), all-cause mortality (RR 0.98; 95% CI: 0.83-1.16; P = 0.818) and cardiovascular mortality (RR: 0.99; 95% CI: 0.73-1.333; P = 0.946) mortality. In addition, two real-world studies comparing DOAC with warfarin showed decreased rates of major cardiovascular events in the DOAC group. CONCLUSION: DOAC use alone or combined with an anti-platelet agent could be associated with lower re-intervention rates, without increasing the risk for adverse bleeding events. However, this study failed to detect any difference in terms of all-cause mortality, MACEs and MALEs between DOAC users and DOAC naïve patients. Future studies are needed to better determine the efficacy and safety of DOACs in patients with PAD.

Multi-parametric assessment of left ventricular hypertrophy using late gadolinium enhancement, T1 mapping and strain-encoded cardiovascular magnetic resonance.

AIM: To evaluate the ability of single heartbeat fast-strain encoded (SENC) cardiovascular magnetic resonance (CMR) derived myocardial strain to discriminate between different forms of left ventricular (LV) hypertrophy (LVH). METHODS: 314 patients (228 with hypertensive heart disease (HHD), 45 with hypertrophic cardiomyopathy (HCM), 41 with amyloidosis, 22 competitive athletes, and 33 healthy controls) were systematically analysed. LV ejection fraction (LVEF), LV mass index and interventricular septal (IVS) thickness, T1 mapping and atypical late gadolinium enhancement (LGE) were assessed. In addition, the percentage of LV myocardial segments with strain ≤ - 17% (%normal myocardium) was determined. RESULTS: Patients with amyloidosis and HCM exhibited the highest IVS thickness (17.4 ± 3.3 mm and 17.4 ± 6 mm, respectively, p < 0.05 vs. all other groups), whereas patients with amyloidosis showed the highest LV mass index (95.1 ± 20.1 g/m2, p < 0.05 vs all others) and lower LVEF compared to controls (50.5 ± 9.8% vs 59.2 ± 5.5%, p < 0.05). Analysing subjects with mild to moderate hypertrophy (IVS 11-15 mm), %normal myocardium exhibited excellent and high precision, respectively for the differentiation between athletes vs. HCM (sensitivity and specificity = 100%, Area under the curve; AUC%normalmyocardium = 1.0, 95%CI = 0.85-1.0) and athletes vs. HHD (sensitivity = 83%, specificity = 75%, AUC%normalmyocardium = 0.85, 95%CI = 0.78-0.90). Combining %normal myocardial strain with atypical LGE provided high accuracy also for the differentiation of HHD vs. HCM (sensitivity = 82%, specificity = 100%, AUCcombination = 0.92, 95%CI = 0.88-0.95) and HCM vs. amyloidosis (sensitivity = 83%, specificity = 100%, AUCcombination = 0.83, 95%CI = 0.60-0.96). CONCLUSION: Fast-SENC derived myocardial strain is a valuable tool for differentiating between athletes vs. HCM and athletes vs. HHD. Combining strain and LGE data is useful for differentiating between HHD vs. HCM and HCM vs. cardiac amyloidosis.

Left and right ventricular strain using fast strain-encoded cardiovascular magnetic resonance for the diagnostic classification of patients with chronic non-ischemic heart failure due to dilated, hypertrophic cardiomyopathy or cardiac amyloidosis.

AIMS: To compare the ability of left ventricular (LV) and right ventricular (RV) strain measured by fast-strain encoded cardiovascular magnetic resonance (CMR) (fast-SENC) with LV- and RV-ejection fraction for the diagnostic classification of patients with different stages of chronic heart failure (stages A-D based on American College of Cardiology/American Heart Association guidelines) due to non-ischemic cardiomyopathies. METHODS: Our study population consisted of 276 consecutive patients who underwent CMR for clinical reasons, and 19 healthy subjects. Wall motion score index and non-infarct related late gadolinium enhancement (LGE), LV ejection fraction (LVEF) and RV ejection fraction (RVEF) and global LV- and RV-longitudinal (GLS) and circumferential strain (GCS) based on fast-SENC acquisitions, were calculated in all subjects. The percentage of LV and RV myocardial segments with strain ≤ - 17% (%normal LV and RV myocardium) was determined in all subjects. RESULTS: LVEF and RVEF, LV-GLS, LV-GCS, RV-GLS, RV-GCS and %normal LV- and RV myocardium depressed with increasing heart failure stage (p < 0.001 for all by ANOVA). By multivariable analysis, %normal LV and RV myocardium exhibited closer associations to heart failure stages than LVEF and RVEF (rpartial = 0.79 versus rpartial = 0.21 for %normal LV myocardium versus LVEF and rpartial = 0.64 versus rpartial = 0.20 for %normal RV myocardium versus RVEF, respectively). Furthermore, %normal LV and RV myocardium exhibited incremental value for the identification of patients (i) with subclinical myocardial dysfunction and (ii) with symptomatic heart failure, surpassing that provided by LVEF and RVEF (ΔAUC = 0.22 for LVEF and ΔAUC = 0.19 for RVEF with subclinical dysfunction, and ΔAUC = 0.19 for LVEF and ΔAUC = 0.22 for RVEF with symptomatic heart failure, respectively, p < 0.001 for all). %normal LV myocardium reclassified 11 of 31 (35%) patients judged as having no structural heart disease by clinical and imaging data to stage B, i.e., subclinical LV-dysfunction. CONCLUSIONS: In patients with non-ischemic cardiomyopathy, %normal LV and RV myocardium, by fast-SENC, enables improved identification of asymptomatic patients with subclinical LV-dysfunction. This technique may be useful for the early identification of such presumably healthy subjects at risk for heart failure and for monitoring LV and RV deformation during pharmacologic interventions in future studies.

Safety, effectiveness and mid-term follow-up in 136 consecutive patients with moderate to severely calcified lesions undergoing phoenix atherectomy.

To investigate the safety and effectiveness of the Phoenix atherectomy device for the treatment of complex and calcified lesions in patients with peripheral artery disease (PAD). 136 consecutive all-comer patients with chronic PAD underwent Phoenix atherectomy. Safety in terms of vessel injury and embolism, efficacy and clinical success in terms of ≥ 1Rutherford class (RF) improvement during follow-up were systematically analyzed. Lesion calcification was categorized by the Peripheral Arterial Calcium Scoring System (PACSS), whereas lesion complexity was classified by the Transatlantic Inter-Society Consensus (TASC). 151 lesions were treated in 136 consecutive patients. Clinical follow-up was available at 10.3 ± 4.2 months in 132 (97%) patients. 55 patients (40%) had intermittent claudication, 16 (12%) rest pain and 65 (48%) had ischemic ulcerations (mean RF class = 4.2 ± 1.1). 15 (11%) patients had TASC B lesions, whereas the majority 72 (53%) and 49 (36%) exhibited TASC C and D lesions, respectively. Mean PACSS score was 3.3 ± 0.9. Mean lesion length was 106 ± 92 mm. Atherectomy was combined with drug-coated balloon (DCB) in 129 (95%) patients. Nine (6.6%) patients with infra-inguinal lesions received stents. Technical and procedural success were recorded in 102 (75%) and 135 (99%), respectively. Perforation was noticed in 2 (1%), whereas asymptomatic embolism occurred in 6 (4%) patients. Clinical success was present in 54 (100%) patients with claudication and in 65 of 78 (83%) patients with critical limb ischemia (CLI). Atherectomy in combination with DCB angioplasty can be safely performed in patients with complex, calcified peripheral lesions with a relatively low rate of bail-out stenting and promising clinical mid-term results.German Clinical Trials Register: DRKS00016708.

Safety and effectiveness of Phoenix atherectomy for endovascular treatment in calcified common femoral artery lesions.

Background: Traditionally endarterectomy has been considered as the gold standard technique for the treatment of common femoral artery (CFA) lesions. The aim of this study is to investigate the procedural safety and mid-term outcomes of minimal invasive Phoenix atherectomy for the treatment of CFA lesions. Patients and methods: Phoenix atherectomy was used for treatment of 61 consecutive, moderately to heavily calcified CFA lesions in 56 patients. Lesions were classified based on the CFA occlusive disease classification (Type I, II&III lesions). Primary endpoints were technical, procedural, and clinical success rate. Safety endpoints (vessel perforation, peripheral embolization) and clinically driven target lesion revascularization (TLR) were also assessed. Results: Of 61 CFA lesions, 58 (95%) exhibited at least moderate/severe calcification (PACSS3 in 38 (62%) and PACSS4 in 20 (33%) cases). Type III lesions were present in 30 (49%), type I/II lesions in 31 (51%) cases. Technical and procedural success was achieved in 30 (49%) and all 61 (100%) lesions, respectively with low complication rates (0% perforation, 2% embolization). Adjunctive treatment after atherectomy was performed using drug-coated balloon (DCB) in 35 (57%) and bail-out stenting in 6 (10%) cases. Target lesion revascularization (TLR) occurred in 4 (7%) cases during a mean follow-up duration of 11±7months. All patients exhibited clinical improvement at follow-up, showing mean Rutherford category reduction from 3.7±1.1 to 1.5±1.1 (p<0.001). Conclusions: The Phoenix device can be used for the effective endovascular treatment of CFA lesions, due to its reasonable safety profile and mid-term results.

Splenic Switch-Off for Determining the Optimal Dosage for Adenosine Stress Cardiac MR in Terms of Stress Effectiveness and Patient Safety.

BACKGROUND: Adenosine stress MRI is well established for the evaluation of known and suspected coronary artery disease. However, a proportion of patients might be "under-stressed" using the standard adenosine dose. PURPOSE: To compare three different adenosine dosages for stress MRI in terms of stress adequacy based on splenic switch-off (SSO) and limiting side effects. STUDY TYPE: Prospective. POPULATION: In all, 100 patients were randomized in group 1 (33 pts), group 2 (34 pts), and group 3 (33 pts), receiving dosages of 140 µg/kg/min, 175 µg/kg/min, or 210 µg/kg/min, respectively. SSO was evaluated visually and quantitatively. SEQUENCE: Stress perfusion was performed using a 1.5T scanner in three short axes using a standard single-shot, saturation recovery gradient-echo sequence. ASSESSMENT: Three blinded experienced operators evaluated SSO on stress and rest perfusion acquisitions in the three groups. The signal intensity of the spleen and myocardium and the presence of inducible ischemia and late gadolinium enhancement were assessed. STATISTICAL ANALYSIS: T-test, analysis of variance (ANOVA), chi-squared test, and Pearson's correlation coefficient. RESULTS: SSO was present more frequently in patients receiving 175 µg/kg/min and 210 µg/kg/min (31/33 [94%] and 27/29 [93%], respectively) compared to those receiving the standard dose (19/33 [58%], P < 0.05). A positive stress result was noted in 3/33 (9%) patients receiving 140 µg/kg/min vs. 9/33 (27%) patients receiving 175 µg/kg/min and 10/31 (33%) patients receiving 210 µg/kg/min (P < 0.05 for all, P < 0.05 for group 1 vs. groups 2, 3). The relative decrease of splenic signal intensity at hyperemia vs. baseline was significantly lower in group 1 compared to groups 2 and 3 (-33% vs. -54%, -56%, respectively; P < 0.05). No adverse events during scanning were noted in groups 1 and 2, whereas in group 3 four examinations were stopped due to severe dyspnea (n = 2) and AV-blockage (n = 2). DATA CONCLUSION: A dosage of 175 µg/kg/min adenosine results in a higher proportion of SSO, which may be an indirect marker of adequate coronary vasodilatation and simultaneously offers similar safety compared to the standard 140 µg/kg/min dosage. LEVEL OF EVIDENCE: 1 TECHNICAL EFFICACY STAGE: 2 J. MAGN. RESON. IMAGING 2020;52:1732-1742.

Comparison of ante-versus retrograde access for the endovascular treatment of long and calcified, de novo femoropopliteal occlusive lesions.

To compare antegrade versus retrograde recanalization, in terms of procedural time, radiation and contrast agent exposure, number and total length of implanted stents and procedural complications, in long and calcified, de novo femoropopliteal occlusions. We performed retrospective matching of prospectively acquired data by lesion length, occlusion length and lesion calcification by the peripheral arterial calcium scoring system (PACSS) score in patients who were referred for endovascular treatment due to symptomatic peripheral artery disease (PAD). Forty-two consecutive patients with antegrade and 23 patients with retrograde after failed antegrade recanalization were identified (mean lesion length = 32.1 ± 6.9 cm; mean occlusion length = 24.6 ± 7.7 cm; PACSS score = 3.25 ± 0.91). 23% of the patients had intermittent claudication, whereas 77% exhibited critical limb ischemia (CLI). Patients who underwent retrograde versus antegrade recanalization required a significantly lower number of stents (0.9 ± 1.0 versus 1.8 ± 1.4, p = 0.01) and a lower total stent length (6.8 ± 8.5 cm versus 11.7 ± 9.9 cm, p < 0.05) in the interest of more extensive coverage of the lesions using drug coated balloons (DCB) (28.5 ± 12.0 cm versus 18.2 ± 16.0 cm, p = 0.01). No re-entry device was required with the retrograde versus 9 of 42 (21%) with the antegrade recanalization group (p = 0.02). The rate of complications due to retrograde puncture was low (one patient with hematoma and one with distal pseudoaneurysm, both managed conservatively). In long and calcified femoropopliteal occlusions, the retrograde approach is associated with a lower number of re-entry devices and stents and with more extensive lesion coverage with DCB, in the interest of costs and possibly long-term patency.German Clinical Trials Register: DRKS00015277.