Preliminary Multicenter Experience Research Articles

Implantation of a novel insertable cardiac monitor: preliminary multicenter experience in Europe.

The LUX-Dx™ is a novel insertable cardiac monitor (ICM) introduced into the European market since October 2022. The aim of this investigation was to provide a comprehensive description of the ICM implantation experience in Europe during its initial year of commercial use. The system comprises an incision tool and a single-piece insertion tool pre-loaded with the small ICM. The implantation procedure involves incision, creation of a device pocket, insertion of the ICM, verification of sensing, and incision closure. Patients receive a mobile device with a preloaded App, connecting to their ICM and transmitting data to the management system. Data collected at European centers were analyzed at the time of implantation and before patient discharge. A total of 368 implantation procedures were conducted across 23 centers. Syncope (235, 64%) and cryptogenic stroke (34, 9%) were the most frequent indications for ICM. Most procedures (338, 92%) were performed in electrophysiology laboratories. All ICMs were successfully implanted in the left parasternal region, oriented at 45° in 323 (88%) patients. Repositioning was necessary after sensing verification in 9 (2%) patients. No procedural complications were reported, with a median time from skin incision to suture of 4min (25th-75th percentiles 2-7). At implantation, the mean R-wave amplitude was 0.39 ± 0.30mV and the P-wave visibility was 91 ± 20%. Sensing parameters remained stable until pre-discharge and were not influenced by patient characteristics or indications. Procedural times were fast, exhibited consistency across patient groups, and improved after an initial experience with the system. Operator Operator feedback on the system was positive. Patients reported very good ease of use of the App and low levels of discomfort after implantation. LUX-Dx™ implantation appears efficient and straightforward, with favorable post-implantation sensing values and associated with positive feedback from operators and patients.

Microendoscopic Tailored Spine Decompression as a Less-Invasive, Stability-Preserving Surgical Option to Instrumented Correction in Complex Spine Deformities: A Preliminary Multicenter Experience

Study designA series of 32 patients, submitted to a tailored stability-preserving micro-endoscopic decompression for lumbar spine degenerative disease was retrospectively analyzed. ObjectivesThe aim of this study is to explore the effectiveness of a less invasive posterior spine decompression in complex deformities. We studied the potential advantages of the micro-endoscopic approach, supplemented by the piezoelectric technique, to decompress both sides of the vertebral canal, from a one side approach to preserve spine stability, ensuring an adequate neural decompression. MethodsThe patients were submitted to a selective bilateral decompression, using a monolateral approach, without the skeletonization of the opposite side. For the omo- and the contralateral decompression, we used a microscopic endoscopy-assisted approach, with the assistance of Piezosurgery, for a safe work near the exposed dura mater. Piezoelectric osteotomy is extremely effective in bone removal while safe on soft tissues. ResultsIn all patients an adequate decompression was achieved with a high rate of spine stability preservation. The approach was essential in minimizing the opening, so reducing the risk of spine instability. Piezoelectric osteotomy was useful to safely perform the undercutting of the base of the spinous process, for a better contralateral vision and decompression without damaging the exposed dura. In all patients a various degree of neurological improvement was observed, with no immediate spine decompensation. ConclusionsIn selected cases, the tailored micro-endoscopic monolateral approach for bilateral spine decompression, with piezosurgery assistance, is adequate and safe and showed excellent results in terms of spine decompression and stability preservation.

P6389S-ICD eligibility according to a novel automated screening tool and agreement with the standard manual ECG morphology tool: a preliminary multicenter experience

P6389S-ICD eligibility according to a novel automated screening tool and agreement with the standard manual ECG morphology tool: a preliminary multicenter experience

P963S-ICD eligibility according to a novel automated screening tool and agreement with the standard manual ECG morphology tool: a preliminary multicenter experience

P963S-ICD eligibility according to a novel automated screening tool and agreement with the standard manual ECG morphology tool: a preliminary multicenter experience

Maxillary Posterior Segmentation Using an Oscillating Saw in Le Fort I Posterior or Superior Movement Without Pterygomaxillary Separation

Any remaining tuberosity or pterygoid plate frequently interferes with posterior or superior movement of the maxilla, if no pterygomaxillary separation is performed in low-level Le Fort I osteotomy. The objective of this report is to describe a technique for maxillary posterior segmentation using an oscillating saw in Le Fort I posterior or superior movement without pterygomaxillary separation and to present the authors' preliminary multicenter experience with this technique. The authors retrospectively evaluated patients who underwent double-jaw surgery at 3 orthognathic surgery centers from May 2010 to December 2012. In all cases, the segmentation procedure was performed using an oscillating saw on a posterior or tuberosity area of the maxilla before downfracture obtained by leverage alone without pterygomaxillary separation, below or near the lower part of the pterygoid plate. In total, 1,231 patients (411 male and 820 female; mean age, 24.9 yr) were enrolled. Mean surgical time for the maxillary procedure was 55.9 minutes. None of the patients received a blood transfusion, and no significant soft or hard tissue complications clinically compromised the healing of the repositioned maxilla. Mean maxillary posterior and superior movements were 3.4 mm (range, 2.1 to 5.6 mm) and 4.0 mm (range, 1.3 to 5.6 mm), respectively. The preliminary results indicate that this maxillary posterior segmentation procedure using an oscillating saw in low-level stepped Le Fort I osteotomy can be completed safely and effectively for posterior or superior repositioning of the maxilla, with no need to disturb the integrity of the pterygoid plate.

Circulation: Cardiovascular Interventions Editors’ Picks

<i>Circulation: Cardiovascular Interventions</i> Editors’ Picks

Melody Valve Implant Within Failed Bioprosthetic Valves in the Pulmonary Position

Transcatheter pulmonary valve implantation using the Melody valve has emerged as an important therapy for the treatment of postoperative right ventricular outflow tract dysfunction. Melody-in-bioprosthetic valves (BPV) is currently considered an off-label indication. We review the combined experience with transcatheter pulmonary valve implantation within BPVs from 8 centers in the United States and discuss technical aspects of the Melody-in-BPV procedure. A total of 104 patients underwent Melody-in-BPV in the pulmonary position at 8 US centers from April 2007 to January 2012. Ten different types of BPVs were intervened on, with Melody valve implantation at the intended site in all patients. Following Melody valve implant, the peak right ventricle-to-pulmonary artery gradient decreased from 38.7 ± 16.3 to 10.9 ± 6.7 mm Hg (P<0.001), and the right ventricular systolic pressure fell from 71.6 ± 21.7 to 46.7 ± 15.9 mm Hg (P<0.001). There was no serious procedural morbidity, and no deaths related to the catheterization or implant. At a median follow-up of 12 months (1-46 months), no patients had more than mild regurgitation, and 4 had a mean right ventricular outflow tract gradient ≥30 mm Hg. During follow-up, there were 2 stent fractures, 3 cases of endocarditis (2 managed with surgical explant), and 2 deaths that were unrelated to the Melody valve. Transcatheter pulmonary valve implantation using the Melody valve within BPVs can be accomplished with a high rate of success, low procedure-related morbidity and mortality, and excellent short-term results. The findings of this preliminary multicenter experience suggest that the Melody valve is an effective transcatheter treatment option for failed BPVs.

S1444: Self-Expanding Metal Stent (SEMS) With a 6Fr Diameter Introducer Permits Simultaneous Deployment of Bilateral Zilver® Stents for Palliation of Malignant Hilar Obstruction: A Preliminary Multi-Center Experience

Stenting hilar obstruction remains challenging. When bilateral SEMS placement is attempted, failure may occur due to the inability to advance a second SEMS introducer side-by-side the first deployed stent. A new 6Fr introducer for a non-foreshortening nitinol SEMS (Zilver 635®, Cook Endoscopy) permits advancement of side-by-side introducers through a standard duodenoscope working channel (4.2mm). We report our initial experience.

CYBERKNIFE RADIOSURGERY FOR TRIGEMINAL NEURALGIA TREATMENT

Abstract OBJECTIVE Radiosurgery has gained acceptance as a treatment option for trigeminal neuralgia. We report our preliminary multicenter experience treating trigeminal neuralgia with the CyberKnife (Accuray, Inc., Sunnyvale, CA). METHODS A total of 95 patients were treated for idiopathic trigeminal neuralgia between May 2002 and October 2005. Radiosurgical dose and volume parameters were retrospectively analyzed in relation to pain response, complications, and recurrence of symptoms. Optimal treatment parameters were identified for patients who had excellent and sustained pain relief with no complications, including severe or moderate hypesthesia. RESULTS Excellent pain relief was initially experienced by 64 out of 95 patients (67%). The median time to pain relief was 14 days (range, 0.3–180 d). Posttreatment numbness occurred in 45 (47%) of the patients treated. Using higher radiation doses and treating longer segments of the nerve led to both better pain relief and a higher incidence of hypesthesia. The presence of posttreatment numbness was predictive of better pain relief. The overall rate of complications was 18%. At the mean follow-up time of 2 years, 47 of the 95 patients (50%) had sustained pain relief, all of whom were completely off pain medications. CONCLUSION The results of this study suggest the following optimal radiosurgical treatment parameters for treatment of idiopathic trigeminal neuralgia: a median maximal dose of 78 Gy (range, 70–85.4 Gy) and a median length of the nerve treated of 6 mm (range, 5–12 mm).

Treatment of Organ Confined Prostate Cancer with Third Generation Cryosurgery: Preliminary Multicenter Experience

Cryosurgical ablation of the prostate is 1 approach to the treatment of localized prostate cancer. Third generation cryosurgery uses gas driven probes that allow for a decrease in probe diameter to 17 gauge (1.5 mm). The safety, morbidity and preliminary prostate specific antigen (PSA) results of 122 cases are reported. A total of 106 patients have undergone percutaneous cryosurgery using a brachytherapy template with at least 12 months of PSA followup. Immediate and delayed morbidities were evaluated. PSA results at 3 and 12 months were recorded, and failure was defined as the inability to reach a nadir of 0.4 ng/ml or less. Complications in patients undergoing primary cryosurgery included tissue sloughing (5%), incontinence (pads, 3%), urge incontinence/no pads (5%), transient urinary retention (3.3%) and rectal discomfort (2.6%). There were no cases of fistulas or infections. Postoperative impotence was 87% in previously potent patients. For patients who underwent salvage cryosurgery there were no fistulas reported and 2 (11%) patients required pads after salvage cryosurgery. A total of 96 (81%) patients achieved a PSA nadir of 0.4 ng/ml or less at 3 months of followup, while 79 of 106 (75%) remained free from biochemical recurrence at 12 months. A total of 42 (78%) low risk patients (Gleason score 7 or less and PSA 10 or less) remained with a PSA of 0.4 ng/ml or less at 12 months of followup, compared to 37 (71%) high risk patients. All patients were discharged within 24 hours. After a followup of 1 year 3rd generation cryosurgery appears to be well tolerated and minimally invasive. The use of ultrathin needles through a brachytherapy template allows for a simple percutaneous procedure and a relatively short learning curve. A prospective multicenter trial is ongoing to determine the long-term efficacy of this technique.

A NOVEL DETOXIFICATION DEVICE FOR THE TREATMENT OF HEPATIC FAILURE (HF)

Blood purification in patients with HF remains still difficult as many toxins are strongly hound to albumin. Hence, current systems exhibit low removal efficacy or poor biocompatibility. In this paper we present a novel device, Prometheus, for the removal of toxins derived from HF. Prometheus represents a fractionated plasma separation and adsorption (FPSA) technology. Blood flows through a hollow-fiber filter, Albu-Flow, which enables albumin to enter a closed-loop circuit containing two adsorbent cartridges, prometh 01 and prometh 02. Exposure to adsorbents depletes albumin from toxic substances by direct adsorption. Purified albumin finally re-enters the blood stream, which passes through a downstream high-flux dialyzer for HD. Laboratory investigations revealed effective elimination of HF markers such als unconjugated bilirubin (clearance at 200 ml blood flow: 23 ml/min), cholic acid (48 ml/min), tryptophan (93 ml/min), and phenol (177 ml/min). Removal was selective as albumin, ATIII, fibrinogen, immunoglobulins and other plasma components were not affected. Cellular and humoral indices (e.g., PLT, complement, cytokine induction) proved biocompatibility of the treatment. Fractionated plasma separation with direct adsorption translates into effective, selective and biocompatible blood purification for patients with HF. Preliminary multicenter experience with Prometheus confirms excellent performance and showed easy handling in the clinical setting.

Preliminary Experience with a New Sclerosing Foam in the Treatment of Varicose Veins

Recently a new method of using a foam sclerosing agent for the treatment of leg veins has been described. We present a pilot study of a new technique for producing the sclerosing foam (Tessari's method) (SFT) and its use in sclerotherapy of major and minor varicosities. A preliminary multicenter experience of sclerotherapy performed by means of this new kind of sclerosing foam made of purified sodium tetradecylsulfate is described. The authors evaluated the safety and efficacy of different doses and concentrations of the drug as well as different methods of preparing the foam in addition, the results of this technique were evaluated. Over a 6-week period the three authors performed sclerotherapy or duplex-guided sclerotherapy using SFT, treating 77 patients. The SFT was formed using a three-way stopcock and two syringes, mixing air with liquid sodium tetradecylsulfate to create a foam. Each author used different concentrations (0.1-3%) and doses (2-8 ml) of SFT according to the size and number of the veins. Alternate methods of preparing the foam were examined as well. Seventy percent of the sclerotherapy sessions were performed on either the long or short saphenous veins, recurrent varices, or collaterals. Thirty percent of the treatments were for reticular varices and telangiectases. At 1-month follow-up, the vast majority of treated larger veins were either obliterated or showed a normal state of cephalad blood flow. Results for minor varicosities were good, but with related complications of hyperpigmentation and small areas of cutaneous necrosis. Two patients experienced transient scotomas and one patient developed segmental phlebitis of a collateral vein. The best foam was obtained by mixing one part liquid sodium tetradecylsulfate and four to five parts air, but the duration of the foam product was also related to several other factors. This preliminary pilot study demonstrates that the technique of producing sclerosing foam according to Tessari's method (three-way stopcock device) is very promising, especially for larger veins. No serious complications were reported, and further standardization of the method may improve the results and feasibility of this technique. Further studies are needed to validate this new technique.

Preliminary Experience with a New Sclerosing Foam in the Treatment of Varicose Veins

BACKGROUND Recently a new method of using a foam sclerosing agent for the treatment of leg veins has been described. We present a pilot study of a new technique for producing the sclerosing foam (Tessari's method) (SFT) and its use in sclerotherapy of major and minor varicosities. OBJECTIVE A preliminary multicenter experience of sclerotherapy performed by means of this new kind of sclerosing foam made of purified sodium tetradecylsulfate is described. The authors evaluated the safety and efficacy of different doses and concentrations of the drug as well as different methods of preparing the foam in addition, the results of this technique were evaluated. METHODS Over a 6-week period the three authors performed sclerotherapy or duplex-guided sclerotherapy using SFT, treating 77 patients. The SFT was formed using a three-way stopcock and two syringes, mixing air with liquid sodium tetradecylsulfate to create a foam. Each author used different concentrations (0.1–3%) and doses (2–8 ml) of SFT according to the size and number of the veins. Alternate methods of preparing the foam were examined as well. Seventy percent of the sclerotherapy sessions were performed on either the long or short saphenous veins, recurrent varices, or collaterals. Thirty percent of the treatments were for reticular varices and telangiectases. RESULTS At 1-month follow-up, the vast majority of treated larger veins were either obliterated or showed a normal state of cephalad blood flow. Results for minor varicosities were good, but with related complications of hyperpigmentation and small areas of cutaneous necrosis. Two patients experienced transient scotomas and one patient developed segmental phlebitis of a collateral vein. The best foam was obtained by mixing one part liquid sodium tetradecylsulfate and four to five parts air, but the duration of the foam product was also related to several other factors. CONCLUSION This preliminary pilot study demonstrates that the technique of producing sclerosing foam according to Tessari's method (three-way stopcock device) is very promising, especially for larger veins. No serious complications were reported, and further standardization of the method may improve the results and feasibility of this technique. Further studies are needed to validate this new technique.

Diuretics versus calcium-channel blockers in systemic hypertension: A preliminary multicenter experience with hydrochlorothiazide and sustained-release diltiazem

The safety and efficacy of sustained-release diltiazem 120 to 180 mg, 2 times a day, were compared with hydrochlorothiazide 25 to 50 mg, 2 times a day, and the combination of diltiazem and hydrochlorothiazide in 56 patients with mild to moderate hypertension (supine diastolic blood pressure between 95 and 114 mm Hg) using a placebo-controlled, parallel-design protocol. Data from an additional 21 patients were evaluated for safety only. The data reported herein represent the preliminary experience from a larger 200-patient multicenter study. All patients received placebo for 4 weeks, followed by either hydrochlorothiazide or diltiazem titrated to achieve a diastolic blood pressure reduction of ≥10 mm Hg to reach a goal supine diastolic blood pressure of <90 mm Hg. Patients not achieving the treatment goal received hydrochlorothiazide plus diltiazem. At week 14, on maintenance monotherapy, diltiazem and hydrochlorothiazide produced comparable reductions in blood pressure from placebo baseline ( 160.3 ± 24.3 101.7 ± 5.5 to 145.2 ± 24.1 89.8 ± 7.4 mm Hg with diltiazem, 156.0 ± 15.6 103.7 ± 4.7 to 134.1 ± 12.5 89.2 ± 9.5 mm Hg with hydrochlorothiazide, p < 0.001 for both). Diltiazem and hydrochlorothiazide achieved goal blood pressure in 42% and 45% of patients, respectively. The effects in responders were sustained for 6 months. In patients who did not achieve the treatment goal, 63% responded to diltiazem plus hydrochlorothiazide. No clinically significant postural hypotension was observed on any regimen. Heart rate was slightly lower with diltiazem than with hydrochlorothiazide. Adverse effects were minimal with diltiazem, hydrochlorothiazide and diltiazem plus hydrochlorothiazide but more hypokalemia occurred with hydrochlorothiazide. Sustained-release diltiazem used twice daily provided safe and effective therapy for mild to moderate hypertension when used alone or in combination with hydrochlorothiazide. As a monotherapy, sustainedrelease diltiazem is similar in efficacy to hydrochlorothiazide.