Excimer laser coronary angioplasty combined with drug-coated balloon in the treatment of in-stent restenosis.

OBJECTIVES: The aim of this study is to investigate the safety and efficacy of excimer laser coronary angioplasty (ELCA) combined with drug-coated balloons (DCBs) in the treatment of in-stent restenosis (ISR), and to explore whether the contrast injection technique would improve the neointimal tissue ablation of ELCA. METHODS: We studied patients diagnosed with ISR between January 2019 and October 2022 at two medical centers. These patients underwent DCB angioplasty guided by optical coherence tomography (OCT). Based on whether ELCA was performed before DCB treatment, patients were categorized into two groups: the ELCA + DCB group and the DCB group. All patients underwent clinical follow-up 1 year after the procedure. The primary endpoint was the 1-year rate of target lesion revascularization (TLR), which was defined as any repeat percutaneous intervention or bypass surgery on the target vessel conducted to address restenosis or other complications related to the target lesion. The secondary endpoints including immediate luminal gain (ΔMLA, defined as the difference in minimum lumen area before and after the intervention). RESULTS: A total of 85 lesions in 75 patients were included. The mean age of the study population was 64.2 ± 12.0 years, with 81.3% male. Baseline clinical characteristics were well-balanced, and procedural success was 100% in both groups. The ELCA + DCB group (n = 24) exhibited a greater ΔMLA compared to the DCB group (n = 61) (3.57 ± 0.79 mm² vs. 2.50 ± 1.06 mm², [95% confidence interval, CI: 0.57-1.69], p < 0.001), The reduction in 1-year TLR was more frequently observed in patients from the ELCA + DCB group compared to the DCB group (hazard ratio 0.33 [95% CI: 0.11-0.99]; log-rank p = 0.048). The exploratory analysis showed that ELCA with contrast infusion is associated with greater acute lumen gain compared to ELCA with saline infusion (p < 0.001). CONCLUSIONS: The combination of ELCA and DCB is a safe and effective treatment strategy for in-stent stenosis. Additionally, compared with saline injection, ELCA with contrast injection is associated with greater acute lumen gain. However, the optimal contrast agent concentration and long-term outcome of the contrast injection technique need confirmation through larger sample sizes and prospective studies.

The Preliminary Outcome of Laser-Assisted Angioplasty Combined with Endovascular Radiofrequency Ablation for Thromboangiitis Obliterans.

INTRODUCTION: Endovascular therapies have not yet had an ideal effect on thromboangiitis obliterans (TAO) and no data have been published about laser-assisted angioplasty (LA) combined with radiofrequency ablation (RFA) for TAO. This study aimed to investigate the outcome of LA combined with RFA for TAO. METHODS: Sixteen consecutive patients underwent LA and RFA procedures between June 2018 and March 2019 in this prospective pilot study. The clinical outcomes and complications were assessed at 6, 12, and 18 months after the procedure. The primary endpoint was defined as the limb salvage rate and freedom of target-lesion revascularization (f-TLR) of the limb, and the effect on the outcome was assessed by the ankle brachial index (ABI), numerical rating scores (NRSs), and the EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D). RESULTS: Men accounted for 87.5% of the patients. All patients underwent LA, and following the RFA procedure, two patients received bailout stenting (12.50%). The technique success rate was 100%, and no severe complications occurred. The ABI was significantly higher at the 18-month follow-up than at baseline (P < 0.001). The primary and secondary patency rates were 71.82% and 79.80%, respectively, and the f-TLR and limb salvage rates were 90% and 92.86% based on Kaplan-Meier analysis. The EQ-5D value was higher after the procedure than at baseline (P < 0.001), and the NRS value was lower after the procedure than at baseline (P < 0.001). CONCLUSIONS: Our results confirmed that LA combined with RFA was a feasible procedure that resulted in acceptable limb salvage and f-TLR rates.

The combination of excimer laser ablation and drug eluting balloon for treating superficial femoral arterial occlusion following stent implantation: A case report.

RATIONALE: Recent research shows that in-stent restenosis (ISR) occurs in half of the patients treated with stenting of femoral and popliteal artery for lower extremity arteriosclerotic occlusive disease (LEASO). Combined therapy is mainly used clinically to obtain better medium- and long-term treatment outcomes and reduce the occurrences of reintervention, among which, the combination of excimer laser ablation (ELA) and drug eluting balloon (DEB) is a new and effective choice. PATIENT CONCERNS: A 76-year-old male patient with ISR of right superficial femoral artery after stent implantation was reported. DIAGNOSIS: Rechecking angiography indicated severe occlusion of the right superficial femoral artery. The physical examination showed that bilateral femoral and popliteal arteries were accessible whereas right dorsalis and posterior tibial arteries are unaccessible. Ankleolus brachial index (ABI) was 0.92 for left and 0.58 for right. INTERVENTIONS: We performed the operation with ELA and drug balloon DEB on the right superficial femoral artery under local anesthesia and treated with oral antiplatelet drugs after operation. OUTCOMES: The combination treatment was very successful, and postoperative lower extremity arteriogram showed the blood flow was fluent and fast. No recurrence was discovered 3 months after the operation and he had no obvious symptom of claudication. LESSONS: The combination of ELA and DEB is useful and effective for ISR of peripheral vessel after stent implantation, and this surgical method is worthwhile but need further clinical research for safety confirmation.

The Bridge Occlusion Balloon for Venous Angioplasty in Superior Vena Cava Occlusion.

The Bridge Occlusion Balloon is a compliant balloon, specifically designed for temporary Superior vena cava occlusion in case of Superior Vena Cava laceration during lead extraction procedures. We here report the first case, using Bridge Occlusion Ballon for a venous angioplasty in a patient with dysfunctional pacemaker leads and symptomatic Superior Vena Cava occlusion. After successful lead extraction, venography was showing a narrow venous canal. Therefore, venous angioplasty using the Bridge balloon was performed. Especially for high-risk lead extraction cases in patients with Superior Vena Cava stenosis, the Bridge Occlusion Ballon might be used as a combination of a safety-net in case of Superior Vena Cava perforation and for Superior Vena Cava angioplasty.

The bridge occlusion balloon for venous angioplasty in superior vena cava occlusion

Abstract The Bridge Occlusion Balloon is a compliant balloon, specifically designed for temporary Superior vena cava occlusion in case of Superior Vena Cava laceration during lead extraction procedures. We here report the first case, using Bridge Occlusion Ballon for a venous angioplasty in a patient with dysfunctional pacemaker leads and symptomatic Superior Vena Cava occlusion. After successful lead extraction, venography was showing a narrow venous canal. Therefore, venous angioplasty using the Bridge balloon was performed. Especially for high-risk lead extraction cases in patients with Superior Vena Cava stenosis, the Bridge Occlusion Ballon might be used as a combination of a safety-net in case of Superior Vena Cava perforation and for Superior Vena Cava angioplasty.

Low Risk of Pulmonary Vein Stenosis After Contemporary Atrial Fibrillation Ablation　- Lessons From Repeat Procedures After Radiofrequency Current, Cryoballoon, and Laser Balloon.

BACKGROUND: The incidence of pulmonary vein stenosis (PVS) after AF ablation following contemporary procedures remains unclear. We compared the incidence of PVS/narrowing (PVS/N) after PV isolation (PVI) for (1) 3-D mapping-guided wide-area encircling irrigated radiofrequency current (RFC) ablation; (2) first-third-generation big cryoballoon (CB1-3) ablation; and (3) laser balloon (LB) ablation.Methods and Results:All patients undergoing a second procedure between January 2012 and November 2016 were subgrouped according to index ablation (PVI): RFC; CB; or LB. PVS/N was classified using PV diameter ratio (second/index procedure) on selective PV angiogram performed before ablation: mild, 25-49%; moderate, 50-74%; or severe, ≥75%. A total of 344 patients (1,362 PV) were analyzed (RFC, n=211; 840 PV; CB1, n=21; 82 PV; CB2,3, n=64; 250 PV; LB, n=48; 190 PV). In the LB group, 45 patients (94%) were treated with dose ≥8.5 W. Second procedures were performed on average 14.9±14.1 months after the index procedure. Mild PVS/N was observed in 18.4%, 9.5% and 3.6% of PV in the LB, RFC and CB groups, respectively (P<0.01). Moderate PVS was recognized in 2 PV (0.1%; RFC, LB). Severe PVS was never observed, and no PV intervention/surgery was required. CONCLUSIONS: The risk for significant PVS is low after RFC/CB. The incidence of mild PVS/N was highest after standard-dose LB ablation and lowest after high-dose CB ablation.

Long-term outcomes of patients with diabetes mellitus undergoing percutaneous intervention for popliteal and infrapopliteal peripheral arterial disease.

OBJECTIVES: To evaluate the association of diabetes mellitus (DM) with clinical and angiographic characteristics and outcomes of patients with popliteal and infrapopliteal peripheral arterial disease (PAD) undergoing peripheral vascular intervention (PVI). BACKGROUND: Clinical features and outcomes in patients with DM and popliteal or infrapopliteal PAD undergoing PVI are not well described. METHODS: Using the data from the laser in popliteal and infrapopliteal stenosis study, we retrospectively examined the association of diabetes with clinical and angiographic characteristics and risk adjusted short- and intermediate term outcomes (all cause death, major adverse events (MAE) [composite of death, ipsilateral major amputation, or repeat revascularization]) in patients with popliteal and infrapopliteal PAD undergoing PVI for critical limb ischemia treated either with laser-assisted balloon angioplasty or balloon angioplasty alone. RESULTS: Of 714 patients, 418 had DM (58.5%). Patients with DM were younger with higher prevalence of history of coronary artery disease, heart failure, end-stage renal disease, and prior contralateral limb amputation compared to those without DM. At 5 years, mean event free survival for all cause mortality (39.9 vs. 45.5 months; P = 0.001), MAE (29.3 vs. 36.8 months; P < 0.001), ipsilateral major amputation (55.3 vs. 57.4 months; P = 0.001), and repeat revascularization (42.0 vs. 45.8 months; P = 0.03) were significantly lower in DM patients. On multivariate analysis, DM was associated with significantly higher all cause mortality (HR = 1.83, 95% CI 1.33-2.52), MAE (HR = 1.73, 95% CI 1.35-2.23), and ipsilateral major amputation (HR = 5.52, 95% CI 1.82-16.71). CONCLUSIONS: Among patients with popliteal and infrapopliteal PAD undergoing PVI, DM was associated with higher mortality, major amputations and MAE that was independent of baseline comorbidities. Our data suggested the need for future studies evaluating existing and/or novel therapies to improve the poor long-term outcomes in diabetic patients with popliteal and infrapopliteal PAD.

Laser Atherectomy Combined With Drug-Coated Balloon Angioplasty Is Associated With Improved 1-Year Outcomes for Treatment of Femoropopliteal In-Stent Restenosis.

PURPOSE: To examine whether laser atherectomy combined with drug-coated balloons (laser + DCB) can improve the outcomes of femoropopliteal (FP) in-stent restenosis (ISR). METHODS: A dual-center retrospective study was conducted of 112 consecutive patients (mean age 70.3±10.6 years; 86 men) with Tosaka class II (n=29; diffuse stenosis) or III (n=83; occlusion) FP-ISR lesions. Sixty-two patients (mean age 68.5±10 years; 51 men) underwent laser + DCB while the other 50 patients (mean age 72.5±10.8 years; 35 men) had laser atherectomy plus balloon angioplasty (laser + BA). Critical limb ischemia was the indication in 33% of the interventions. The average lesion length was 247 mm. A Cox regression hazard model was developed to examine the association between laser + DCB vs laser + BA; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). One-year target lesion revascularization (TLR) and reocclusion were estimated using the Kaplan-Meier method. RESULTS: Overall procedure success was 98% and was similar between groups. Bailout stenting was less often required in the laser + DCB group (31.7% vs 58%, p=0.006). The combination of laser + DCB was associated with improved 12-month estimates for freedom from TLR (72.5% vs 50.5%, p=0.043) and freedom from reocclusion (86.7% vs 56.9%, p=0.003). Among patients with Tosaka III FP-ISR, combination therapy with laser + DCB was also associated with increased freedom from reocclusion (87.1% vs 57.1%, p=0. 028). On multivariable analysis, treatment with laser + DCB was associated with a significantly reduced risk of reocclusion (HR 0.08, 95% CI 0.17 to 0.38; p=0.002). CONCLUSION: When used for treatment of complex FP-ISR lesions, DCB angioplasty combined with laser atherectomy is associated with significantly reduced 1-year TLR and reocclusion rates.

The combined use of Drug-eluting balloon and Excimer laser for coronary artery Restenosis In-Stent Treatment: The DERIST study.

AIM: Stents reduce angiographic restenosis in comparison with balloon angioplasty. The rate of in-stent restenosis (ISR), although less frequent than post-angioplasty restenosis, is becoming increasingly prevalent due to the recent exponential increase in the use of intracoronary stents. The aim of this study is to evaluate angiographic and clinical outcomes of PTCA in combination with the use of excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) in treatment of in-stent restenosis (ISR). METHODS AND RESULTS: This multi-centric case-control study evaluated angiographic and clinical outcomes of PTCA with excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) in 80 patients with in-stent restenosis (ISR). All patients underwent nine months of clinical and a coronary angiography follow-up. This study showed clinical and angiographic long-term success in the 91% of the patients. The incidence of myocardial infarctions and deaths was lower than the rate after plain balloon angioplasty within the stent. CONCLUSIONS: This study showed that excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) may be an alternative treatment for in-stent restenosis (ISR).

Laser-Assisted Removal of Embedded Vena Cava Filters: A 5-Year First-in-Human Study.

BACKGROUND: Many patients are subjected to the potential risks and morbidity associated with an indwelling inferior vena cava (IVC) filter when standard methods fail to remove the filter. We evaluated the safety and effectiveness of the excimer laser sheath technique for removing embedded IVC filters. METHODS: Over a 5-year period, 251 consecutive patients undergoing laser-assisted filter retrieval were prospectively enrolled. There were 103 men and 148 women (mean, 46 years; range, 15-82 years). Indications for retrieval included symptomatic acute IVC thrombosis, chronic IVC occlusion, and/or pain from filter penetration. Retrieval was also performed to prevent risks from prolonged implantation and potentially to eliminate the need for lifelong anticoagulation. After retrieval failed using three times the standard retrieval force (digitally measured), treatment escalation was attempted using a laser sheath powered by a 308-nm XeCl laser. Success was defined as complete filter detachment and removal from the body. Primary safety outcomes were major procedure-related complications. RESULTS: Laser-assisted retrieval was successful in 249 of 251 patients (99.2%) (95% CI, 97.2%-99.9%), with a mean implantation of 979 days, range: 37-7,098 days (> 19 years), among retrievable-type filters (n = 211) and permanent-type filters (n = 40). Average force during failed attempts without laser was 6.7 vs 3.8 lbs during laser-assisted retrievals (P < .0001). The major complication rate was 1.6% (95% CI, 0.4%-4.0%), and all were successfully treated. Successful retrieval allowed cessation of anticoagulation in 45 of 46 patients (98%) (95% CI, 88%-99%) and alleviated filter-related morbidity in 55 of 57 patients (96%) (95% CI, 88%-99%). CONCLUSIONS: The excimer laser sheath technique is safe and effective for removing embedded IVC filters refractory to standard retrieval and high force. This technique can be used to alleviate or prevent filter-related morbidity and may allow cessation of filter-related anticoagulation. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01158482; URL: www.clinicaltrials.gov.

Novel experience of laser-assisted 'inside-out' central venous access in a patient with bilateral subclavian vein occlusion requiring pacemaker implantation.

AIM: This new laser facilitated 'inside-out' technique was used for transvenous pacemaker insertion in a pacemaker-dependent patient with bilateral subclavian occlusion and a failed epicardial system who is not suitable for a transfemoral approach. METHOD AND RESULTS: Procedure was undertaken under general anaesthesia with venous access obtained from right femoral vein and left axillary vein. 7F multipurpose catheter was used to enter proximal edge of the occluded segment of subclavian vein via femoral approach, which then supported stiff angioplasty wires and microcatheters to tunnel into the body of occlusion. When encountered with impenetrable resistance, 1.4 mm Excimer laser helped delivery of a Pilot 200 wire, which then progressed towards the distal edge of occlusion. Serial balloon dilatations allowed wire tracked into subintimal plane, advanced towards left clavicle using knuckle wire technique, which was then externalized with blunt dissection from infraclavicular pocket area. It was later changed to Amplatz superstiff wire exiting from both ends to form a rail, which ultimately allowed passage of pacing leads after serial balloon dilatation from clavicular end. CONCLUSION: Our hybrid 'inside-out' technique permitted transvenous pacemaker insertion without complication and this is, to our knowledge, the first case using laser in this context.

A retrospective analysis of laser endartherectomy assisted balloon angioplasty for popliteal and infrapopliteal peripheral arterial disease.

OBJECTIVES: To describe our single center experience with the use of laser endartherectomy assisted balloon angioplasty in popliteal and infrapopliteal arterial disease. BACKGROUND: Peripheral arterial disease (PAD) carries significant morbidity to patients. Some patients may have multiple comorbid conditions potentially limiting therapeutic options for PAD. Endovascular interventions are aimed at decreasing arterial disease symptoms, improve wound healing and ultimately limb salvage. There is limited data on below the knee PAD and simultaneous laser endartherectomy use in this anatomic location. METHODS: The cohort comprised 41 patients that underwent laser assisted balloon angioplasty from 2010 to 2013. All patients had popliteal and infrapopliteal arterial disease. Outcomes evaluated were limb salvage and symptom relief 12months following the procedure. A comparison between the patients that underwent amputation and those with limb salvage was also performed. RESULTS: All the patients had TASC II (Trans Atlantic Inter-Society Consensus) type D lesions. Most patients reported persistent PAD symptoms by six months, with 17% remaining symptom free by 12months. Affected limb salvage was 69%. Five patients (12%) died and one third of the patients had a new peripheral angiogram. In the repeat angiogram, most patients showed initial target vessel occlusion. No statistically significant differences were found between the patients that preserved their limb to those who underwent amputation. CONCLUSIONS: Laser assisted balloon angioplasty use for complex popliteal and infrapopliteal arterial disease is a therapeutic option when limb salvage is the goal. Despite this, symptom recurrence and the need for repeated angiography continue to be high.

Laserballoon and Cryoballoon Pulmonary Vein Isolation in Persistent and Longstanding Persistent Atrial Fibrillation.

BACKGROUND: Visually guided laserballoon (LB) ablation has recently been introduced for pulmonary vein (PV) isolation (PVI). We analyzed efficacy and safety results of the newly introduced LB ablation technique in patients with persistent and longstanding persistent atrial fibrillation (AF), and compared this with an established standard method using the cryoballoon (CB). METHODS: A total of 35 patients with symptomatic persistent AF underwent LB ablation and were followed-up for 1 year. Results were compared to 35 patients who underwent CB ablation at the same institution and case matched for age, sex, CHA2 DS2 -VASc score, and left atrial volume. RESULTS: Complete isolation of all PVs was achieved in 68.6% in the LB and 97.1% in the CB group (P < 0.01). No significant differences were found for AF-free survival after 12 months in the complete cohort of all patients (LB: 53.3% vs CB: 70.4%; P = n.s.) and after excluding patients without complete PVI (LB: 57.8% vs CB: 72.5%; P = n.s.). LB ablation resulted in longer procedure (158.5 ± 37.9 minutes vs 110.9 ± 26.5 minutes; P < 0.01) and fluoroscopy durations (28.4 ± 11.1 minutes vs 23.5 ± 9.4 minutes; P = 0.04.), and a trend toward more major complications (14.3% vs 2.9%; P = n.s.). Procedure durations and complications declined over time and were level with CB-treated patients when reaching the last quartile of the LB patients. CONCLUSION: PVI in patients with persistent AF using the LB or the CB resulted in comparable success rates. Initial prolongations in procedure and safety parameters as a result of a learning curve effect for the LB have to be considered before starting to use this technique.

Relation of Baseline Renal Dysfunction With Outcomes in Patients Undergoing Popliteal and Infrapopliteal Percutaneous Peripheral Arterial Interventions.

Renal dysfunction is a major risk factor for peripheral arterial disease (PAD). Infrapopliteal PAD is associated with more co-morbid conditions and worse prognosis than suprapopliteal PAD. Long-term outcomes of patients with renal dysfunction and popliteal or infrapopliteal PAD undergoing peripheral vascular intervention (PVI) are not well described. We retrospectively evaluated long-term outcomes in 726 patients undergoing infrapopliteal PVI categorized into 3 glomerular filtration rate (GFR)-based groups: GFR (≥60 ml/min/1.73 m(2)), GFR (<60 ml/min/1.73 m(2)), and those on dialysis. At mean follow-up of 36 ± 20 months, amputation rates were 3%, 5%, and 11% with mortality rates of 23%, 36%, and 56% in normal renal function, chronic kidney disease (adjusted odds ratio [OR] for amputation 1.75, 95% CI 0.73 to 4.21; adjusted OR for mortality 1.53, 95% CI 1.05 to 2.23, p = 0.028), and dialysis (adjusted OR for amputation 2.43, 95% CI 0.84 to 7.02, p = 0.100; adjusted OR for mortality 4.51, 95% CI 2.46 to 8.26, p <0.0001) groups, respectively. Repeat revascularization was similar in all 3 groups at roughly 25%. In conclusion, chronic kidney disease and dialysis were associated with increased major amputations and mortality in patients who received PVI for popliteal and infrapopliteal PAD.