Bailout Stenting Research Articles

Atherectomy for peripheral arterial disease.

Symptomatic peripheral arterial disease (PAD) has several treatment options, including angioplasty, stenting, exercise therapy, and bypass surgery. Atherectomy is an alternative procedure, in which atheroma is cut or ground away within the artery. This is the first update of a Cochrane Review published in 2014. To evaluate the effectiveness of atherectomy for peripheral arterial disease compared to other established treatments. The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Allied and Complementary Medicine (AMED) databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 12 August 2019. We included all randomised controlled trials that compared atherectomy with other established treatments. All participants had symptomatic PAD with either claudication or critical limb ischaemia and evidence of lower limb arterial disease. Two review authors screened studies for inclusion, extracted data, assessed risk of bias and used GRADE criteria to assess the certainty of the evidence. We resolved any disagreements through discussion. Outcomes of interest were: primary patency (at six and 12 months), all-cause mortality, fatal and non-fatal cardiovascular events, initial technical failure rates, target vessel revascularisation rates (TVR; at six and 12 months); and complications. We included seven studies, with a total of 527 participants and 581 treated lesions. We found two comparisons: atherectomy versus balloon angioplasty (BA) and atherectomy versus BA with primary stenting. No studies compared atherectomy with bypass surgery. Overall, the evidence from this review was of very low certainty, due to a high risk of bias, imprecision and inconsistency. Six studies (372 participants, 427 treated lesions) compared atherectomy versus BA. We found no clear difference between atherectomy and BA for the primary outcomes: six-month primary patency rates (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.94 to 1.20; 3 studies, 186 participants; very low-certainty evidence); 12-month primary patency rates (RR 1.20, 95% CI 0.78 to 1.84; 2 studies, 149 participants; very low-certainty evidence) or mortality rates (RR 0.50, 95% CI 0.10 to 2.66, 3 studies, 210 participants, very low-certainty evidence). One study reported cardiac failure and acute coronary syndrome as causes of death at 24 months but it was unclear which arm the participants belonged to, and one study reported no cardiovascular events. There was no clear difference when examining: initial technical failure rates (RR 0.48, 95% CI 0.22 to 1.08; 6 studies, 425 treated vessels; very low-certainty evidence), six-month TVR (RR 0.51, 95% CI 0.06 to 4.42; 2 studies, 136 treated vessels; very low-certainty evidence) or 12-month TVR (RR 0.59, 95% CI 0.25 to 1.42; 3 studies, 176 treated vessels; very low-certainty evidence). All six studies reported complication rates (RR 0.69, 95% CI 0.28 to 1.68; 6 studies, 387 participants; very low-certainty evidence) and embolisation events (RR 2.51, 95% CI 0.64 to 9.80; 6 studies, 387 participants; very low-certainty evidence). Atherectomy may be less likely to cause dissection (RR 0.28, 95% CI 0.14 to 0.54; 4 studies, 290 participants; very low-certainty evidence) and may be associated with a reduction in bailout stenting (RR 0.26, 95% CI 0.09 to 0.74; 4 studies, 315 treated vessels; very low-certainty evidence). Four studies reported amputation rates, with only one amputation event recorded in a BA participant. We used subgroup analysis to compare the effect of plain balloons/stents and drug-eluting balloons/stents, but did not detect any differences between the subgroups. One study (155 participants, 155 treated lesions) compared atherectomy versus BA and primary stenting, so comparison was extremely limited and subject to imprecision. This study did not report primary patency. The study reported one death (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence) and three complication events (RR 7.04, 95% CI 0.80 to 62.23; 155 participants; very low-certainty evidence) in a very small data set, making conclusions unreliable. We found no clear difference between the treatment arms in cardiovascular events (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence). This study found no initial technical failure events, and TVR rates at six and 24 months showed little difference between treatment arms (RR 2.27, 95% CI 0.95 to 5.46; 155 participants; very low-certainty evidence and RR 2.05, 95% CI 0.96 to 4.37; 155 participants; very low-certainty evidence, respectively). This review update shows that the evidence is very uncertain about the effect of atherectomy on patency, mortality and cardiovascular event rates compared to plain balloon angioplasty, with or without stenting. We detected no clear differences in initial technical failure rates or TVR, but there may be reduced dissection and bailout stenting after atherectomy although this is uncertain. Included studies were small, heterogenous and at high risk of bias. Larger studies powered to detect clinically meaningful, patient-centred outcomes are required.

Long term outcome after treatment of de novo coronary artery lesions using three different drug coated balloons

ObjectiveTo evaluate the long-term efficacy of three currently available drug coated balloons (DCB) for the treatment of de-novo coronary lesions. MethodsThis was a retrospective analysis of prospectively collected data from the Swedish Coronary Angiography and Angioplasty Registry. Between 2009 and 2017, three currently available DCB brands used in the treatment of de novo lesions were included. Outcomes were clinically driven restenosis and target lesion thrombosis (TLT) (per device) and major adverse cardiac events (MACE) including death, myocardial infarction or target vessel revascularization (per patient) at 4 years. Multivariable Cox regression models were used to adjust for differences. ResultsWe included 6715 lesions treated with DCBs, 4483 SeQuent® Please (S-DCB), 1071 IN.PACT Falcon (I-DCB) and 1161 Pantera® Lux (P-DCB), in 5670 patients. The mean DCB diameter was 2.4 mm. Bailout stenting occurred in 6.7% of lesions. Angiographic success was 98.5%.The overall cumulative rate of restenosis was 5.5% (299 events). The risk for reported restenosis did not significantly differ between I-DCB vs S-DCB, adjusted hazard ratio (aHR) 0.96; 95% confidence interval (CI) 0.69–1.34, P-DCB vs S-DCB aHR 0.88; 95% CI 0.63–1.23 and I-DCB vs P-DCB aHR 1.10; 95% CI 0.72–1.68. The cumulative risk for TLT was 0.8% in all three DCBs. The risk for MACE or individual components of MACE did not differ between the three patient-groups. ConclusionIn de novo coronary lesions, we found comparable long-term efficacy with three currently available DCB brands. DCB angioplasty was feasible with low risk for long-term restenosis and TLT.

BIOLUX P-III Passeo-18Lux All-Comers Registry: 24-Month Results in Below-the-Knee Arteries.

The BIOLUX P-III registry was initiated to further assess the safety and efficacy of the Passeo-18Lux drug-coated balloon (DCB) in infrainguinal lesions in a real-world environment and in prespecified risk groups. BIOLUX P-III is a prospective, global, all-comers registry with patients treated under real-world conditions. We herein report 24-month results of the prespecified subgroup of 151 patients with 185 below-the-knee (BTK) lesions. The primary safety and efficacy endpoints were freedom from major adverse events (a composite of freedom from device and procedure mortality through 30days, major target limb amputation and clinically driven target lesion revascularization) at 6months and freedom from clinically driven target lesion revascularization (FfTLR) at 12months. At baseline, 76.0% of patients had critical limb ischemia and 48.9% of lesions were TASC C or D lesions. Technical success was achieved in 97.8%, and bailout stenting was required in 1.1%. Freedom from major adverse events was 86.2% [95% CI 79.4; 90.8] at 6months, and FfTLR was 90.9% [95% CI 85.2; 94.4] at 12months. At 24months, FfTLR was 90.9% [95% CI 85.2; 94.4], freedom from major amputation was 90.1% [95% CI 83.9, 94.0], and overall survival was 79.2% [70.7, 85.5]. There was a significant clinical improvement (mean Rutherford class improvement of - 2.9 ± 1.9, p < 0.0001) and an improvement in pain (mean improvement on Wong-Baker Faces Pain Scale of - 2.7 ± 2.9, p < 0.0001). In this real-world DCB registry, 24-month outcomes of Passeo-18Lux demonstrated safety and efficacy in BTK lesions with high patency rates and sustained clinical improvements at 24months. NCT02276313.

Laser Atherectomy for Infrapopliteal Lesions in Patients With Critical Limb Ischemia

BackgroundInfrapopliteal (IP) lesions are common in patients with critical limb ischemia (CLI). Optimal revascularization strategies including the use of adjunctive atherectomy have the potential to improve the outcomes for these patients. ObjectiveTo compare laser atherectomy (LA) vs. balloon angioplasty alone for the treatment of IP lesions in patients with CLI. MethodsThis was a two-center retrospective study of patients with CLI who underwent endovascular interventions for IP lesions. One and 2-year target lesion revascularization (TLR) was the primary outcome. One and 2-year limb loss and major adverse limb events (MALE) were secondary outcomes. Propensity score matching was performed. A Cox regression analysis was used to compare 1- and 2-year outcomes of the two groups. Logistic regression analysis was used to compare the two groups in terms of bail-out stenting and procedural complications. ResultsA total of 313 patients with CLI were included; 76 were treated with LA. There was a high degree of lesion complexity in both groups. Consistent with the application of LA in the most complex lesions, lesions in the LA group were significantly longer (165.7 mm vs. 94.1 mm; p < 0.001) and were more frequently TASC C/D (82% vs. 45%; p < 0.001). In-stent restenosis (ISR) lesions were also more common among the LA group (14% vs. 0.4%; p < 0.001). Thrombotic lesions were present in 11% of the LA group vs. 4% in the no LA group (p = 0.04). CTOs were also more common in the LA group (58% vs. 43%; p = 0.024). After propensity matching, there was no difference in the 1 or 2-year TLR rates between the two groups. Similarly, there were no differences between the two groups in terms of 1 or 2-year limb loss or 2-year major adverse limb events. ConclusionsLA is safe and effective for IP lesions in patients with CLI. There was a higher baseline angiographic complexity in patients treated with LA, suggesting that operators tend to use LA for the treatment of more complicated lesions. There was no difference among the two groups in 1- or 2-year outcomes of TLR of major amputation.

Combination of Percutaneous Rotational Thrombectomy and Drug-Coated Balloon for Treatment of Femoropopliteal Artery Nonembolic Occlusion: 12-Month Follow-up

PurposeTo evaluate safety and efficacy of percutaneous mechanical thrombectomy using the Rotarex catheter combined with drug-coated balloon (DCB) in treatment of femoropopliteal artery occlusive disease. Materials and MethodsBetween January 2016 and February 2018, 81 patients with acute or subacute femoropopliteal artery occlusions were treated with the Rotarex catheter combined with DCB. Lesions were classified according to the onset of symptoms as acutely (< 14 d) or subacutely (14 d to 3 mo) occluded. The mean lesion length was 12.1 cm ± 6.7. The primary endpoint was target lesion patency at 1 year as evaluated by duplex ultrasound (peak systolic velocity ratio < 2.4) and freedom from clinically indicated target lesion revascularization. Amputation rate, major adverse events, and ankle-brachial index at 12 months were evaluated. ResultsTechnical success rate was 100% (n = 81). Bailout stents were necessary in 14 patients owing to residual stenosis or flow-limiting dissection. Additional thrombolysis was applied in 10 interventions. No major adverse events occurred during hospital stay. There were 9 restenosis cases during the 12-month follow-up period. Primary patency rate was 87.3% (62/71), and freedom from target lesion revascularization rate was 90.1% (64/71). Ankle-brachial index significantly increased from 0.46 ± 0.15 to 0.77 ± 0.14 during follow-up. The amputation rate was 1.4% at 12 months. ConclusionsThese initial data from 2 centers suggest that the combination of the Rotarex catheter and DCB may be safe and effective for treatment of acute or subacute thrombotic femoropopliteal occlusion with superior immediate and midterm results achieved.

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 ± 4.2months 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 ± 92mm. 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.

JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study

Purpose: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). Materials and Methods: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR (ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI). Results: Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively. Conclusion: JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR.

Clinical Outcomes and Angiographic Results of Bailout Stenting for Guide Catheter-Induced Iatrogenic Coronary Artery Dissection - Impact of Stent Type.

Guide catheter-induced iatrogenic coronary artery dissection is a rare but feared complication. When it occurs, bailout stenting is widely performed; however, its prognosis and the impact of stent type remains unclear. The study population consisted of 77,257 consecutive patients (coronary angiography, 55,864; percutaneous coronary intervention, 21,393) between 2000 and 2015. We investigated the incidence, clinical outcomes, and angiographic results after bailout stenting and compared by stent type: bare-metal stent (BMS) and drug-eluting stent (DES). Iatrogenic coronary artery dissection occurred in 105 patients (incidence rate, 0.14%). All cases of iatrogenic coronary artery dissection that were recognized as requiring bailout procedure could be managed by stent implantation, and no patients died during bailout procedure. The 5-year cumulative incidences of cardiac death, target lesion revascularization, and major adverse cardiac events were 11.3%, 10.3%, and 21.0%, respectively. The binary restenosis rate was 10.4%, and it was not significantly different between BMS and DES implantation. In lesions with preprocedural stenosis, however, it was significantly lower in the DES group than in the BMS group. On the other hand, coronary artery dissection recurred in 8 patients, which was observed only after DES implantation. The immediate and long-term outcomes of bailout stenting for iatrogenic coronary artery dissection were acceptable. Although DES may be favorable for stenotic lesions, coronary artery dissection can recur after DES implantation.

Drug-Coated Balloon for De Novo Coronary Artery Lesions: A Systematic Review and Trial Sequential Meta-analysis of Randomized Controlled Trials.

Objective To investigate the efficacy of drug-coated balloon (DCB) treatment for de novo coronary artery lesions in randomized controlled trials (RCTs). Background DCB was an effective therapy for patients with in-stent restenosis. However, the efficacy of DCB in patients with de novo coronary artery lesions is still unknown. Methods Eligible studies were searched on PubMed, Web of Science, EMBASE, and Cochrane Library Database. Systematic review and meta-analyses of RCTs were performed comparing DCB with non-DCB devices (such as plain old balloon angioplasty (POBA), bare-metal stents (BMS), or drug-eluting stents (DES)) for the treatment of de novo lesions. Trial sequential meta-analysis (TSA) was performed to assess the false positive and false negative errors. Results A total of 2,137 patients enrolled in 12 RCTs were analyzed. Overall, no significant difference in target lesion revascularization (TLR) was found, but there were numerically lower rates after DCB treatment at 6 to 12 months follow-up (RR: 0.69; 95% CI: 0.47 to 1.01; P = 0.06; TSA-adjusted CI: 0.41 to 1.16). TSA showed that at least 1,000 more randomized patients are needed to conclude the effect on TLR. A subgroup analysis from high bleeding risk patients revealed that DCB treatment was associated with lower rate of TLR (RR: 0.10; 95% CI: 0.01 to 0.78; P = 0.03). The systematic review illustrated that the rate of bailout stenting was lower and decreased gradually. Conclusions DCB treatment was associated with a trend toward lower TLR when compared with controls. For patients at bleeding risk, DCB treatment was superior to BMS in TLR.

10-Year Paclitaxel Dose-Related Outcomes of Drug-Eluting Stents Treated Below the Knee in Patients with Chronic Limb-Threatening Ischemia (The PADI Trial)

PurposeRecently, two meta-analyses concluded that there appears to be an increased risk of long-term mortality of paclitaxel-coated balloons and stents in the superficial femoral and popliteal artery, and paclitaxel-coated balloons below the knee. In this post hoc study of the PADI Trial, we investigated the long-term safety of first-generation paclitaxel-coated drug-eluting stents (DES) below the knee and the dose–mortality relationships of paclitaxel in patients with chronic limb-threatening ischemia (CLI).Materials and MethodsThe PADI Trial compared paclitaxel-coated DES with percutaneous transluminal angioplasty with bail-out bare-metal stents (PTA ± BMS) in patients with CLI treated below the knee. Follow-up was extended to 10 years after the first inclusion, and survival analyses were performed. In addition, dose-related mortality and dose per patient weight-related mortality relations were examined.ResultsA total of 140 limbs in 137 patients were included in the PADI Trial. Ten years after the first inclusion, 109/137 (79.6%) patients had died. There was no significant difference between mortality in the DES group compared with the PTA ± BMS group (Log-rank p value = 0.12). No specific dose-related mortality (HR 1.00, 95% CI 0.99–1.00, p = 0.99) or dose per weight mortality (HR 1.05, 95% CI 0.93–1.18, p = 0.46) relationships were identified in the Cox-proportional Hazard models or by Kaplan–Meier survival analyses.ConclusionsThere is a poor 10-year survival in both paclitaxel-coated DES and PTA ± BMS in patients with CLI treated below the knee. No dose-related adverse effects of paclitaxel-coated DES were observed in our study of patients with CLI treated below the knee.Level of EvidenceThe PADI Trial: level 1, randomized clinical trial

Clinical performance of a novel sirolimus-coated balloon in coronary artery disease: EASTBOURNE registry.

The purpose of the EASTBOURNE registry is to evaluate the immediate and long-term clinical performance of a novel sirolimus-coated balloon (SCB) in a real-world population of patients with coronary artery disease. We here present the prespecified interim analysis after the enrollment of the first 642 patients who obtained 1-year clinical follow-up. EASTBOURNE is a prospective, international, multicenter, all-comer investigator-driven clinical registry, which is enrolling consecutive patients treated with SCB at 42 European and Asiatic centers. Primary study endpoint is target-lesion revascularization (TLR) at 12 months. Secondary endpoints are procedural success and major adverse cardiac events through 36 months. Diabetes mellitus was present in 41% of patients. Acute coronary syndrome was present in 45% of patients and de novo lesions were 55%; 83% of the in-stent restenosis (ISR) patients had drug-eluting stents restenosis. Lesion predilatation was performed in 95% of the cases and bailout stenting occurred in 7.5%. So far, 642 patients have a complete 12-month follow-up. TLR occurred in 2.5%, myocardial infarction in 2.3%, total death in 1% and major adverse cardiac events in 5.8% of patients. A prespecified analysis of comparison between ISR and de-novo lesions showed a significantly higher occurrence of TLR in the ISR population (5.4 vs. 0.2%, P = 0.0008). The current interim analysis of 12-month follow-up of the EASTBOURNE registry shows good immediate performance and an adequate and encouraging safety profile through 12 months for this novel SCB.

Management of iatrogenic left main coronary artery dissection in a center without onsite cardiac surgery back up

Catheter-related iatrogenic left main coronary artery dissection is an extremely rare complication that can cause fatal outcomes if not recognized and treated early. In the current approach, conservative follow-up, bailout stenting with percutaneous intervention and bypass surgery treatment options are available. However, in some centers, coronary angiography and interventional applications are performed without surgical support. Management of such rare but important complications becomes more complex in these centers. In this experience, we wanted to share after her approval, how we managed catheter-induced iatrogenic left main coronary artery dissection in a 72-year-old female patient with bailout stenting and conservative approach in a center without surgical back up.

Evaluation of superficial femoral artery-lesions after percutaneous transluminal angioplasty: color-coded summation images vs. monochromatic digital subtraction angiography

BackgroundPercutaneous transluminal angioplasty (PTA) is increasingly requested in the therapy of peripheral arterial occlusive disease. The evaluation of the technical result after balloon angioplasty with regard to bailout stenting is highly dependent on the operators´ subjective assessment and mainly based on the monochromatic digital subtraction angiography (DSA) images. The aim of this study was to compare color-coded single image as a novel diagnostic tool with monochromatic DSA for the analysis of flow limitation and need for stent implantation after PTA of superficial femoral artery (SFA) stenoses.MethodsDuring a period of 18 months, 213 SFA lesions were treated by PTA with a standard balloon in 170 patients, resulting in a total of 193 endovascular procedures. The median age of the patients was 77 years (range, 35–96 years). Median length of the treated lesions was 10.5 cm (range, 1.0–50 cm). Three interventional radiologists retrospectively evaluated the results of balloon angioplasty with monochromatic as well as post-processed color-coded DSA images for flow limitations to decide if subsequent stent implantation was necessary. Consensus reading of two experienced interventional radiologists 2 months after the initial review served as reference standard to perform a receiver operating characteristics (ROC) analysis.ResultsROC analysis for readers A, B and C showed area under the curve (AUC) values of 0.797, 0.865 and 0.804 for color-coded DSA and AUC values of 0.792, 0.843 and 0.872 for monochromatic DSA: a significant advantage of color-coded over conventional monochromatic DSA was not found for readers A and B (p > 0.05). Results of reader C were significantly better in the assessment of monochromatic images (p = 0.023). Diagnostic confidence using color-coded images was slightly higher than in monochromatic images (κ = 0.486 vs. κ = 0.459).ConclusionsIn this study, color coded DSA did not reveal to be superior to conventional monochromatic DSA when evaluating results of PTA and when deciding whether stent implantation is necessary or not. This technology, however, requires further experiences with special regard to homogeneously trained radiologists and to the time requirement.

Shockwave™ Lithoplasty in Combination With Atherectomy in Treating Severe Calcified Femoropopliteal and Iliac Artery Disease: A Single-Center Experience

BackgroundCalcium is a predictor of poor outcome in the treatment of infrainguinal arterial disease. Rotational atherectomy can effectively debulk atherosclerotic calcium but is less likely to significantly modify medial and adventitial calcinosis. Shockwave IVL provides circumferential sonic pressure waves capable of disrupting deeper calcium and theoretically complements the debulking process of atherectomy. We present acute and intermediate outcome data from patients with severe femoral or iliac artery calcified disease treated with the combination of rotational atherectomy and Shockwave IVL at a single center. MethodsThis is a retrospective study of prospectively collected data on rotational atherectomy (Jetstream (Boston Scientific) and orbital atherectomy (CSI)) from a single operator at a single center with core laboratory analysis of angiographic imaging. All patients that received the combination treatment of rotational atherectomy and Shockwave IVL were included in this study. Patient follow-up was done from medical records with data extracted by an experienced research coordinator. Primary safety endpoint was freedom from major adverse events including major dissection (NHLBI C or higher), perforation, distal embolization, or major amputation defined as amputation above the ankle. Primary effectiveness endpoint was procedural success (≤ 30% residual at end of procedure). 23/24 (95.8%) patients were treated with drug coated balloons (DCB) post combination therapy. Secondary endpoint on follow-up was target lesion revascularization (TLR). ResultsA total of 24 patients were included. Mean age was 70.7 ± 9.9 years. Lesions were in the femoropopliteal 79.1%, common femoral 12.5% and iliac 8.3% arteries. 87.0% were claudicants and 58.3% diabetics. Chronic total occlusion was 12.5%, severe calcium 100%, lesion length 84.5 ± 37.1 mm, baseline stenosis 57.1 ± 18.9% and baseline minimal luminal diameter (MLD) 2.2 ± 1.1 mm. Patients were treated with Jetstream (n = 19) or Orbital (n = 5) atherectomy. Embolic filter was used in 58.3% of cases. Post atherectomy stenosis was 36.4 ± 17.5%, post adjunctive IVL 21.1 + 15.7%, and final stenosis 13.0 ± 10.9%. Bailout stenting was 4.6% and primary stenting 13.6% (total stenting rate 18.2%). Final MLD was 4.7 ± 0.8 mm, resulting in an acute gain of 2.5 mm. No infrapopliteal embolization or amputation was noted. At a mean follow up of 591.4 ± 175.2 days, 2 patients died (unrelated to procedure or device). Target lesion revascularization (TLR) at 12 months occurred in 2 patients or 2/22 (9%). At 18-month of follow up TLR occurred in 7/22 (31%) patients. ConclusionThe combination of atherectomy and shockwave IVL followed by adjunctive DCB is safe and appears to be effective in treating severe calcified disease with acceptable TLR on long term follow-up in a population of severe femoropopliteal disease.

Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis

Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic literature search was conducted in PubMed, Scopus, and Cochrane Central up to January 2020 to identify randomized trials and observational studies presenting data on the effectiveness and safety of DCBs in the treatment of femoropopliteal or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was conducted to investigate primary patency and all-cause mortality at 12 months; the results are reported as the odds ratios (ORs) and 95% confidence intervals (CIs). Secondary outcomes were procedural success, bailout stenting, target lesion revascularization (TLR), reocclusion, major amputation, wound healing, and major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion lengths were 121±44 and 135±53 mm, respectively. The overall 12-month all-cause mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal lesions demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, TLR, major amputation, or mortality over 12 months. However, patients with infrapopliteal lesions undergoing DCB angioplasty did have a significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal lesions in patients with CLTI results in acceptable 12-month patency rates, although comparative data have not shown a patency benefit for infrapopliteal lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not significantly different, but studies with longer-term outcomes are necessary to determine any association between DCB use and mortality in patients with CLTI.

Mid-term clinical outcomes from use of Sirolimus coated balloon in coronary intervention; data from real world population.

Use of drug coated balloons (DCBs) in coronary intervention is escalating. There is a plethora of data on Paclitaxcel-DCB. However, when it comes of stents, Limus-drugs are preferred over Paclitaxel. There is very limited data on Sirolimus coated balloons (SCB). MagicTouch-SCB (Concept Medical, FL) elutes Sirolimus via nano-technology and have been used in our centers since March 2018. We report a mid-term follow-up with this relatively novel-technology. We retrospectively analyzed all patients treated with MagicTouch-SCB between March-2018 and February-2019. Results are reported as cardiac-death, target-vessel myocardial-infarction (TVMI), target lesion revascularization (TLR) and Major Adverse Cardiac Events (MACE). During the study period, 288-patients (373-lesions) with a mean age of 65.8 were treated with MagicTouch-SCB. 84% (n=241) were male, 155 (54%) were in the setting of acute coronary syndrome, 38% (n=110) had diabetes and 62% (n=233) were in de-novo lesions. Most lesions treated were in the LAD/diagonal-system (n=170; 46%). Pre-dilatation was performed in 92% (n=345) of cases. Bailout stenting was required in 9% lesions (n=35). The mean diameter and length of SCBs were 2.64 ± 0.56 mm and 24 ± 8.9 mm respectively. During a median follow-up of 363 days (IQR: 278-435), cardiac death and TVMI occurred in 5-patients (1.7%) and 10-patients (3.4%) respectively, TLR per-lesion was 12%. The MACE rate was 10%. There were no documented cases of acute vessel closure. The results from mid-term follow-up with this relatively new technology SCB is encouraging with a low rates of hard endpoints and acceptable MACE rates despite complex group of patients and lesion subsets.

Optimal Vessel Sizing and Understanding Dissections in Infrapopliteal Interventions: Data From the iDissection Below the Knee Study

Purpose: To investigate if imaging with intravascular ultrasound (IVUS) yields a more accurate estimate of vessel diameter and the presence of dissections than angiography after intervention in the infrapopliteal arteries. Materials and Methods: A prospective, single-center study enrolled 20 consecutive patients (mean age 74.1±12.4 years; 12 women) with infrapopliteal disease who were treated with percutaneous transluminal angioplasty (PTA; n=10) or orbital atherectomy (OA) followed by PTA (n=10). The majority of patients were hypertensive and half were diabetic. The overall lesion length was 7.3±6.3 cm, and the diameter stenosis was 80.3%±22.1%. The baseline characteristics did not differ between the groups. Vessel diameters were measured using IVUS from the internal elastic lamina (IEL) to the IEL. IVUS was performed at baseline, post PTA or OA, and post OA+PTA. Quantitative vascular angiography (QVA) and IVUS were analyzed by a core laboratory. Dissections on cine images were categorized based on the National Heart Lung and Blood Institute (NHLBI) classification, while the arc and depth were used to characterize dissections on IVUS images. Results: Mean vessel diameter by QVA was 2.9±0.6 vs 4.0±1.0 mm by IVUS according to the core laboratory (mean difference 1.1±0.9, p<0.001). On angiography, there were 7 dissections after PTA (6 C, 1 D), 1 dissection after OA (1 B), and 2 dissections after OA+PTA (1 A, 1 B; p=0.028 vs post PTA). IVUS uncovered 3.8 times more dissections than seen on angiography. There were 23 dissections after PTA (18 intima, 3 media, 2 adventitia), 12 dissections after OA (8 intima, 1 media, 3 adventitia), and 11 dissections following OA+PTA (7 intima, 1 media, 3 adventitia; p=0.425 vs PTA). Bailout stenting (all due to angiographic dissections ≥C) was necessary in 6 of the PTA cohort and none of the OA+PTA group. Conclusion: In addition to underestimating the infrapopliteal vessel diameter by ~25%, angiography underappreciated the presence and severity of post-intervention dissections vs IVUS, particularly in the OA+PTA group.

High-pressure, non compliant balloon angioplasty for long and calcified infrapopliteal and inframalleolar lesions is feasible.

To evaluate the safety, feasibility and effectiveness of high-pressure, noncompliant balloon angioplasty in the management of long infrapopliteal calcified lesions. Consecutive patients, presenting with chronic limb-threatening ischemia (CLTI) and long (>100 mm) calcified infrapopliteal lesions who were treated with a high pressure, noncompliant balloon (JADE, OrbusNeich, Hong Kong) between January 2016 and July 2016 were retrospectively analyzed. Angioplasty was performed by inflating the balloon to a pressure of 22 to 24 atm for 90 seconds. Primary outcome was technical success. Secondary outcomes were procedure-related complications, limb salvage, amputation-free survival (AFS), wound healing, overall survival, freedom from clinically driven target lesion reintervention (CD-TLR), and resolution of CLTI at 2 and 3 years. Overall, 23 lesions in 21 limbs of 20 patients were treated. All patients had tissue loss (Rutherford 5 or 6). The mean lesion length was 374.8 mm. Of all lesions, 56.5% were occlusions, 91.3% were classified as TransAtlantic Inter-Society Consensus (TASC) C and D lesions, and 78.3% had severe calcification classification. Of all lesions, 52.2% extended into the below-the-ankle arteries. Technical success was achieved in 22 lesions (95.7%). There were no procedure-related complications. No bailout stenting was required. At 2 and 3 years, limb salvage was 84.7% and 78.7%, AFS was 71.4% and 56.1%, wound healing was 81.0% and 85.7%, overall survival was 75.0% and 64.3% and freedom from CD-TLR was 77.6% and 63.5%, respectively. Resolution of CLTI without TLR was 81.0% at 2 and 3 years. This study is the first to analyze safety and feasibility of a high-pressure, noncompliant balloon for long, calcified infrapopliteal and inframalleolar lesions.

Optimized drug-coated balloon angioplasty of the superficial femoral and proximal popliteal arteries using the Tack Endovascular System: TOBA III 12-month results

ObjectiveThe Tack Endovascular System (Intact Vascular, Wayne, Pa) combines low-metallic content with focal delivery to seal areas of dissection associated with balloon angioplasty. The device system is designed to treat vascular dissections in the superficial femoral and proximal popliteal arteries. Tack implants exert low radial force and are associated with minimal metal burden, which reduces the mechanical stress on the arterial wall in treating dissections after balloon angioplasty. This study investigated the safety and effectiveness of the Tack Endovascular System in patients with dissections after drug-coated balloon (DCB) angioplasty. MethodsThe Tack Optimized Balloon Angioplasty III (TOBA III) study is a prospective, multicenter, single-arm study in which patients who underwent percutaneous transluminal angioplasty with the Medtronic IN.PACT Admiral DCB (Medtronic, Dublin, Ireland) and experienced dissection after angioplasty were treated with Tack implants. The primary end points were freedom from major adverse events at 30 days and primary patency at 12 months. ResultsA total of 201 patients were enrolled in the trial, 169 with standard-length lesions (≥20 mm and ≤150 mm) and 32 with long-length lesions (>150 mm and ≤250 mm). Safety and effectiveness results were favorable compared with historical benchmarks at 12 months in the standard-lesion cohort. Notably, patients in the standard-lesion cohort experienced 95.0% primary patency, 97.5% freedom from clinically driven target lesion revascularization, 100% freedom from amputation, and 100% survival at 12 months (P < .0001). Primary patency in long-lesion patients was 89.3%, freedom from clinically driven target lesion revascularization was 96.8%, and freedom from amputation was 100% at 12 months. Device success was achieved in 95.8% (182/190) and 97.7% (43/44) of devices deployed into standard-lesion and long-lesion patients, respectively. Procedural success was 99.4% (168/169) and 100% (44/44) in the standard-lesion and long-lesion cohorts, respectively, with only one bailout stent placed in the entire population. ConclusionsThe Tack Endovascular System is a safe and effective treatment option for patients with dissections after angioplasty in the superficial femoral and proximal popliteal arteries, with high patency, low rates of secondary intervention, and low incidence of bailout stenting when it is used in combination with DCB.

Excimer laser coronary atherectomy prior to paclitaxel-coated balloon angioplasty for de novo coronary artery lesions

This study aimed to evaluate the efficacy and safety of excimer laser coronary atherectomy (ELCA) prior to paclitaxel-coated balloon angioplasty for de novo coronary artery lesions. This retrospective observational study analyzed 118 eligible patients with de novo coronary artery disease whose only percutaneous coronary intervention was a drug-coated balloon angioplasty (i.e., no subsequent stent placement). Data related to our primary outcomes of interest—incidence of major adverse cardiovascular and cerebral events (MACCE), and incidence of procedural complications (bailout stenting and minor complications)—were collected and retrospectively analyzed. ELCA was used significantly more often in the cases of main branch and ostial lesions (i.e., of the circumflex, right coronary, or left anterior descending arteries, or high lateral branch), normally associated with poor treatment outcomes (55.6% vs. 14.3%, p < 0.0005). However, the two groups were not different in terms of cumulative incidence as estimated by the Kaplan–Meier method (log-rank test, p = 0.603) and a causal relationship between ELCA and MACCE was not identified (OR, 2.223; 95% CI, 0.614–8.047; p = 0.223). This study confirms the safety of ELCA prior to paclitaxel DCB angioplasty to treat de novo coronary artery lesions. While difficult-to-treat lesions were significantly more prevalent in the group treated by ELCA, the study revealed similar efficiency as conventional pre-dilation methods. Our findings provide grounds for a prospective randomized trial with consistent lesion and procedural characteristics to evaluate the potential benefits of combining paclitaxel DCB angioplasty following ELCA for de novo coronary artery lesions.