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.

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.

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.

Ablación de fibrilación auricular con balón láser de guía visual: una experiencia en la «práctica clínica real» / Visually-guided laser balloon ablation of atrial fibrillation: a "real world" experience

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Aislamiento eléctrico venoso pulmonar con catéter láser en el tratamiento de la fibrilación auricular paroxística y persistente. Resultados a un año / Electrical isolation of pulmonary veins using laser catheter in the treatment of paroxysmal and persistent atrial fibrillation. One-year results

Introducción y objetivos: Recientemente se ha introducido un nuevo catéter-balón láser para el aislamiento eléctrico venoso pulmonar que permite la visualización del tejido auricular. El objetivo del presente trabajo es evaluar la seguridad y la eficacia a medio plazo de este catéter en el tratamiento de la fibrilación auricular. Métodos: Se realizó ablación con catéter-balón láser a 71 pacientes con fibrilación auricular paroxística (80%) y persistente (20%). Se consideró recurrencia arrítmica los episodios de duración > 30 s. Durante el seguimiento se realizaron visitas periódicas cada 3 meses con Holter 24-48 h. Resultados: Se logró aislar 275 de 278 (99%) de las venas pulmonares. Los tiempos medios de procedimiento y de fluoroscopia fueron 154 ± 25 y 34 ± 15 min respectivamente. Un 89% de las venas se aislaron en el primer intento. La complicación más frecuente fue la parálisis del nervio frénico (5,6%), que apareció solo en los primeros 18 casos. Se siguió a 59 pacientes durante una media de 420 ± 193 días, con una tasa de recurrencia arrítmica del 12 y el 30% respectivamente en fibrilación auricular paroxística y persistente (p = 0,155). Conclusiones: El catéter-balón láser es un sistema seguro y efectivo para lograr el aislamiento eléctrico de las venas pulmonares. Entre sus ventajas destaca la capacidad de adaptarse a la anatomía venosa pulmonar con un único catéter y la eficacia con que logra el aislamiento eléctrico de las venas pulmonares, con una evolución clínica favorable a medio plazo, incluso para los pacientes con fibrilación auricular persistente (AU)

Introduction and objectives: A new laser balloon that allows visualization of atrial tissue has recently been introduced for pulmonary vein electrical isolation. The aim of this study was to evaluate the mid-term safety and efficacy of this catheter in the treatment of atrial fibrillation. Methods: Laser balloon ablation was performed in 71 patients with paroxysmal (80%) or persistent (20%) atrial fibrillation. Arrhythmia recurrence was defined as any episode lasting longer than 30 seconds. During follow-up, regular visits were performed every 3 months with 24- to 48-hour Holter tests. Results: Isolation was possible in 275 of 278 (99%) of pulmonary veins. Mean procedure and fluoroscopy times were 154 ± 25 and 34 ± 15 minutes, respectively. A total of 89% of veins were isolated during the first attempt. The most common complication was phrenic nerve paralysis (5.6%), which appeared in only the first 18 cases. A total of 59 patients received follow-up for a mean of 420 ± 193 days, with a rate of arrhythmia recurrence of 12% and 30%, respectively, in paroxysmal and persistent atrial fibrillation (P = .155). Conclusions: The laser balloon is a safe and effective system for pulmonary vein electrical isolation. Its advantages include the capacity to adapt to pulmonary vein anatomy using a single catheter, the efficacy with which pulmonary vein electrical isolation is achieved, and the favorable mid-term clinical progress, even for patients with persistent atrial fibrillation (AU)

Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation.

BACKGROUND: Balloon catheters have been designed to facilitate pulmonary vein (PV) isolation in patients with paroxysmal atrial fibrillation (AF). The visually guided laser balloon (VGLB) employs laser energy to ablate tissue under direct visual guidance. OBJECTIVES: This study compared the efficacy and safety of VGLB ablation with standard irrigated radiofrequency ablation (RFA) during catheter ablation of AF. METHODS: Patients with drug-refractory paroxysmal AF were enrolled in a multicenter, randomized controlled study of PV isolation using either the VGLB or RFA (control). The primary efficacy endpoint was freedom from protocol-defined treatment failure at 12 months, including symptomatic AF occurring after the 90-day blanking period. The primary efficacy and safety endpoints were powered for noninferiority. RESULTS: A total of 353 patients (178 VGLB, 175 control) were randomized at 19 clinical sites. The mean procedure, ablation, and fluoroscopy times were longer with VGLB compared with controls. The primary efficacy endpoint was met in 61.1% in the VGLB group versus 61.7% in controls (absolute difference -0.6%; lower limit of 95% confidence interval [CI]: -9.3%; p = 0.003 for noninferiority). The primary adverse event rate was 11.8% in the VGLB group versus 14.5% in controls (absolute difference -2.8%; upper limit of 95% CI: 3.5; p = 0.002 for noninferiority), and was mainly driven by cardioversions. Diaphragmatic paralysis was higher (3.5% vs. 0.6%; p = 0.05), but PV stenosis was lower (0.0% vs. 2.9%; p = 0.03) with VGLB. CONCLUSIONS: Despite minimal prior experience, the safety and efficacy of VGLB ablation proved noninferior to RFA for the treatment of paroxysmal AF. (Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System-Adaptive Contact [EAS-AC] [HeartLight] in Patients With Paroxysmal Atrial Fibrillation [PAF] [HeartLight]; NCT01456000).

Early outcome of high energy Laser (Excimer) facilitated coronary angioplasty ON hARD and complex calcified and balloOn-resistant coronary lesions: LEONARDO Study.

AIM: An innovative xenon-chlorine (excimer) pulsed laser catheter (ELCA X80) has been recently used for the treatment of complex coronary lesions, as calcified stenosis, chronic total occlusions and non-compliant plaques. Such complex lesions are difficult to adequately treat with balloon angioplasty and/or intracoronary stenting. The aim of this study was to examine the acute outcome of this approach on a cohort of patients with coronary lesions. METHODS AND RESULTS: Eighty patients with 100 lesions were enrolled through four centers, and excimer laser coronary angioplasty was performed on 96 lesions (96%). Safety and effectiveness data were compared between patients treated with standard laser therapy and those treated with increased laser therapy. Laser success was obtained in 90 lesions (93.7%), procedural success was reached in 88 lesions (91.7%), and clinical success in was obtained in 87 lesions (90.6%). There was no perforation, major side branch occlusion, spasm, no-reflow phenomenon, dissection nor acute vessel closure. Increased laser parameters were used successfully for 49 resistant lesions without complications. CONCLUSIONS: This study suggests that laser-facilitated coronary angioplasty is a simple, safe and effective device for the management of complex coronary lesions. Furthermore, higher laser energy levels delivered by this catheter improved the device performance without increasing complications.

[Two-year results of a prospective randomised controlled multicenter trial to compare open operative therapy vs. endoluminal venous laser therapy with and without high ligation for the therapy of varicose greater saphenous veins]. / Zweijahresergebnisse einer prospektiv-randomisierten kontrollierten Multicenterstudie zum Vergleich der offen operativen Therapie vs. der lasergestützten endoluminalen Therapie mit und ohne Crossektomie zur Therapie der Varikose der V. saphena magna.

INTRODUCTION: Therapeutic options for the treatment of varicosis of the great saphenous vein (gsv) include endoluminal laser therapy, crossectomy/stripping and a combination of both. In this paper we present data for clinical and sonographic inguinal recurrencies up to two years post operation. MATERIAL AND METHODS: In an open multicentre, randomised three-arm trial, sonographic and clinical parameters were compared perioperatively, after 2, 6, 12 and 24 months between endoluminal venous laser therapy, high ligation and invaginating stripping and a combination of both (laser: 980 nm, continuous mode, 30 W, Biolitec®, Jena, Germany). Data of 449 patients were available for the perioperative and 2 months examination. 388 patients were followed up until 6, 380 patients for 12 and 332 patients for 24 months. We compared clinical recurrences, sonographic reflux findings, and reflux side branches in the inguinal region at the saphenofemoral junction. RESULTS: We found significantly more inguinal reflux and reflux side branches in the laser groups (p < 0.0001), however, there was no statistically significant relation between clinical recurrences and sonographic reflux. Over time, there were no intraindividual constant refluxes. Regarding the secondary endpoints oedema, lymphatic oedema, local disturbances of sensibility and irritations of the saphenous nerve, lymphatic oedema and irritations of the saphenous nerve were significantly more present in the two laser groups. After two years pain and restrictions in professional life were no longer relevant in all groups. DISCUSSION: Clinical recurrences developed both in the C/S and in the laser group but reflux into the gsv and into proximal side branches developed significantly more often in the laser group. In a long-term follow-up we have to investigate the importance of reflux side branches for the development of clinical recurrences to reveal differences between the three therapeutic strategies.

In-stent restenosis: mid-term results of debulking using excimer laser and drug-eluting balloons: sustained benefit?

BACKGROUND: In-stent restenosis (ISR) after endovascular treatment of stenotic and occlusive disease of the infrainguinal arteries is still a clinical challenge. The purpose of this study is to evaluate the mid-term follow-up of a combination therapy using laser debulking and drug-eluting balloons for ISR. METHODS: A prospective cohort of 14 patients (10 female, 4 male) with clinically relevant (Rutherford 3-6) ISR who were treated with excimer-laser angioplasty and drug-eluting balloons and a clinical follow-up of at least 9 months was evaluated. RESULTS: Mean age was 78 ± 6.5 years (range, 67-88 years). The mean lesion length treated was 133.2 ± 107.2 mm (range, 10-380 mm). The mean time to occurrence of restenosis after initial treatment was 8.6 ± 4.7 months (range, 2-18 months). Technical success was 100%. Distal embolization occurred in 2 cases, and was treated successfully by endovascular means. No other periprocedural major adverse events occurred. All patients were available for clinical follow-up and 12 patients were available with Duplex follow-up. At a mean clinical follow-up of 19.1 ± 8.7 months (range, 9-38 months), 1 target lesion revascularization was seen (at 3 years after the ISR treatment). In the patients with critical limb ischemia (n = 7), no major amputations were needed. Twelve patients had Duplex control (mean follow-up, 19.4 ± 9.4 months; range, 9-38 months). Binary restenosis (>50%) was seen in 1 case at 36 months; it was the same patient who had TLR. A 25%-50% stenosis was seen in 4 patients (mean follow-up, 25 months; range, 19-38 months). No sign of neointimal hyperplasia was demonstrated in 7 patients (mean follow-up, 14.3 months; range, 9-19 months). CONCLUSION: These mid- to long-term data compare favorably with results obtained with standard balloon angioplasty, cutting-balloon angioplasty, and balloon angioplasty using drug-eluting balloon. Longer follow-up and randomized trials are necessary to further define the role of combined excimer-laser debulking and drug-eluting balloon angioplasty in the treatment of ISR.

Predictores de hospitalización prolongada en cardiología / Predictors of prolonged hospitalization in cardiology

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Comparison of balloon catheter ablation technologies for pulmonary vein isolation: the laser versus cryo study.

INTRODUCTION: Balloon catheters have been developed to facilitate pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). We sought to compare the safety and efficacy of the cryoballoon (CB) and the laserballoon (LB) in a pilot study. METHODS AND RESULTS: One hundred and forty patients with drug-refractory PAF were prospectively allocated in a 1:1 fashion to undergo a PVI procedure with the 28 mm CB or the LB and were followed for 12 months using 3-day Holter ECG recording. The primary efficacy endpoint was a documented AF recurrence ≥ 30 seconds between 90 and 365 days after the index ablation. In total, 269 of 270 PVs (99.6%) and 270 of 273 PVs (98.9%) were acutely isolated in the CB and LB group, respectively. Mean procedural time was 136 ± 30 minutes for the CB group and 144 ± 33 minutes for the LB group (P = 0.13). Mean fluoroscopy time was longer in the CB group (21 ± 9 minutes vs 15 ± 6 minutes; P < 0.001). During 12 months follow-up, 37% of patients in the CB group and 27% in the LB group experienced an AF recurrence (P = 0.18). Phrenic nerve palsies occurred in 5.7% (CB) and 4.2% (LB) of patients, respectively. CONCLUSION: Balloon catheters are a viable option to safely perform a PVI procedure in patients with drug-refractory PAF. Ninety-nine percent of PVs may be acutely isolated with a single balloon catheter. The AF free survival rate after a single ablation procedure was not statistically different between groups.

Pulmonary vein isolation with a novel endoscopic ablation system using laser energy.

Pulmonary vein isolation (PVI) is the basis of all ablation techniques for paroxysmal atrial fibrillation. Performing conventional radiofrequency ablation for PVI is time consuming and sometimes challenging when using point-by-point applications to create continuous lesions. Small electrically conducting gaps evolving in the ablation lines may cause recurrences of atrial fibrillation or regular atrial re-entry tachycardias. Development of novel anatomically designed ablation catheters for PVI aim to facilitate the ablation procedure, to produce continuous and durable lesions with a limited number of ablation impulses and to reduce the complication rate. The endoscopic laser balloon ablation system (HeartLight® EAS, Cardiofocus Inc.) is the first system that allows direct visual guidance of energy delivery at the antral level of each pulmonary vein and uses a completely new energy source for ablation.

A novel approach for under-expanded stent: excimer laser in contrast medium.

The novel approach of using excimer laser in a contrast medium for treating an under-expanded stent in a calcified coronary artery is described. In this first reported case, the laser in a contrast medium was used to treat an under-expanded stent deployed 18 months prior in a calcified non-dilatable coronary artery lesion. The normal laser approach in saline medium flush during lasing to clear any contrast was not effective. The use of concurrent contrast during lasing was effective and successful to help expand the stent with a successful outcome.