Superficial femoral artery recanalization with self-expanding nitinol stents: long-term follow-up results.

PURPOSE: Since long-term patency and device integrity of nitinol stents in SFA lesions are not well studied, we examined clinical outcome, patency and device integrity after stenting long lesions using a standardized implantation technique. METHODS: Between 2001 and 2006, 59 patients (74 lesions) were treated with the same nitinol self-expandable stent (Zilver, Cook, USA) and technique for SFA recanalization. Clinical charts and imaging were retrospectively reviewed for patency (primary and assisted-primary), and device integrity. RESULTS: Patients were 74.5 (10.9) years old (range 49 to 93), 64% male, 42% diabetic, 62% hypertensive and 67% current or former smokers. Lesions were 23% TASC B, 16% TASC C, or 61% TASC D. Mean recanalization length was 19 cm (range 3 to 53). Mean number of stents per patient was 2.8 (total 210). Mean follow-up time was 2.4 years (range 3 days to 4.8 years). Kaplan-Meier estimates for primary patency rates were 90%, 78%, 74%, 69%, and 69% at 1, 2, 3, 4 and 4.8 years, respectively. Ten restenoses at a mean of 500 (388) days (1-1251 days) were successfully recanalized. The assisted primary patency rates were 96%, 90%, 90%, 90% and 90% at 1, 2, 3, 4 and 5 years, respectively. Six complete occlusions could not be reverted by a second recanalization procedure, and were treated by surgical bypass (1 case), amputation (3 cases), or medical management (2 cases). One (1.04%) Class II stent fracture was noted. CONCLUSIONS: SFA recanalization with a standardized implantation technique and nitinol stents provides good long-term primary and assisted-primary patency.

Recommendations for extraction of chronically implanted transvenous pacing and defibrillator leads: indications, facilities, training. North American Society of Pacing and Electrophysiology Lead Extraction Conference Faculty.

The procedure of lead removal has recently matured into a definable, teachable art with its own specific tools and techniques. It is now time to recognize and formalize the practice of lead removal according to the current methods of medicine and the health care industry. In addition, since at this time the only prospective scientific study of lead extraction is the PLEXES trial, we suggest that studies relating to the techniques of and indications for lead extraction be designed. Recommendations for a common set of definitions, for a framework of training and reviewing physicians in the art, for general methods of reimbursement, and for consistency among clinical trials have been made. Implementation of these recommendations will require additional effort and cooperation from practicing physicians, medical societies, hospital administrations, and industry.

Intravascular extraction of problematic or infected permanent pacemaker leads: 1994-1996. U.S. Extraction Database, MED Institute.

Of the 400,000-500,000 permanent pacemaker leads implanted worldwide each year, around 10% may eventually fail or become infected, becoming potential candidates for removal. Intravascular techniques for removing problematic or infected leads evolved over a 5-year period (1989-1993). This article analyzes results from January 1994 through April 1996, a period during which techniques were fairly stable. Extraction of 3,540 leads from 2,338 patients was attempted at 226 centers. Indications were: infection (27%), nonfunctional or incompatible leads (25%), Accufix or Encore leads (46%), or other causes (2%). Patients were 64+/-17 years of age (range 5-96); 59% were men, 41% women. Leads were implanted 47+/-41 months (maximum 26 years), in the atrium (53%), ventricle (46%), or SVC (1%). Extraction was attempted via the implant vein using locking stylets and dilator sheaths, and/or transfemorally using snares, retrieval baskets, and sheaths. Complete removal was achieved for 93% of leads, partial for 5%, and 2% were not removed. Risk of incomplete or failed extraction increased with implant duration (P<0.0001), less experienced physicians (P<0.0001), ventricular leads (P<0.005), noninfected patients (P<0.0005), and younger patients (P<0.0001). Major complications were reported for 1.4% of patients (<1% at centers with >300 cases), minor for 1.7%. Risk of complications increased with number of leads removed (P<0.005) and with less experienced physicians (P<0.005); risk of major complications was higher for women (P<0.01). Given physician experience, appropriate precautions, and appropriate patient selection, contemporary lead removal techniques allow success with low complication rates.

Conductive interstitial hyperthermia in the treatment of intracranial metastatic disease.

BACKGROUND: Intracranial metastases commonly complicate oncologic care affecting 140,000 patients per year in the United States. Treatment of these tumors is difficult and often unsuccessful. Hyperthermia is a treatment alternative that has shown promise in treating cancer in other areas. Therefore it was employed in an attempt to provide increased tumor control in CNS metastases. METHODS: This Phase I and Phase II clinical trial of interstitial hyperthermia with recurrent or progressive intracranial metastatic disease was undertaken to evaluate complications, delivery of heat and patient outcome. RESULTS: Feared complications of clinically significant bleeding, increased mass, or infection from the interstitial implant and treatment did not occur. The seizures which occurred in 4 patients were controlled with additional anticonvulsants. Three venous thromboembolic events were treated medically and with percutaneously placed inferior vena cava filters. The KPS of the majority of patients declined slightly with treatment but rebounded to near baseline within several months. CT scans demonstrated decrease or stabilization of tumor volumes in 7 of the 13 patients. In 4 of these patients, regression or stabilization persisted until death from nonCNS disease. CONCLUSIONS: Interstitial hyperthermia therapy for intracranial metastases is technically feasible and may provide increased tumor control. In this small series, it did not cause unreasonable complications. This therapy has some positive effect, but requires study of more patients before its role is definitively known. Combining hyperthermia with brachytherapy and/or chemotherapy is being evaluated.

Five-years experience with intravascular lead extraction. U.S. Lead Extraction Database.

From December 1988 to April 1994, the extraction of 2,195 intravascular pacing leads from 1,299 patients was attempted at 193 centers. Indications were: infection (54%, including 10% septicemia), pacemaker reoperation with removal of nonfunctional or incompatible leads (40%), and other causes (6%). Extraction was attempted via the implant vein using locking stylets and dilator sheaths, via the femoral vein using snares, retrieval baskets, and sheaths, or via both approaches. Leads had been implanted for 0.2 months to 24 years (mean 56 months). At the conclusion of the intravascular procedure, 86.8% of the leads were completely removed, 7.5% were partially removed, and 5.7% were not removed. For physicians performing their first case, 12% of leads were not removed; for physicians who had performed more than 10 cases, only 2% of leads were not removed. Of the 189 leads where extraction attempts had previously failed, 75.1% were completely removed, 14.8% were partially removed, and 10.1% were not removed. Scar tissue increased in severity with implant duration, was a complicating factor, and was the main cause of failure to remove leads. Use of the femoral approach increased with implant duration (5% of leads implanted 12 months or less, 11% of leads 13 months to 3 years, 20% of leads 4-7 years, and 31% of leads 8-24 years), primarily because of increasingly abundant scarring and prior lead damage. Fatal and near fatal complications occurred in 2.5%, including 8 (0.6%) deaths (3 hemopericardium/tamponade, 1 hemothorax, 3 pulmonary embolus, 1 stroke).(ABSTRACT TRUNCATED AT 250 WORDS)

Electrosurgical safety of guide wires during endoscopic sphincterotomy.

UNLABELLED: A study was performed to determine whether alternate site electrosurgical burns could be caused by an inadequately insulated guide wire left in place during endoscopic papillotomy to maintain cannulation of the common bile duct. The safety of four covered guide wires and one standard guide wire was evaluated for electrosurgical safety. All four covered guide wires were coated with polyurethane or polytetrafluoroethylene (Teflon), providing insulation. Leakage currents under normal, limiting case, and fault (damaged insulation) conditions were compared to safety limits. All covered guide wires met safety limits under normal conditions, one of four covered guide wires met safety limits under limiting case conditions, and none met safety limits under fault conditions. The uncovered guide wire did not meet the safety limit under any conditions. CONCLUSION: Without a well-insulated guide wire with intact coating, our measurements indicate that leaving a guide wire in place during papillotomy may result in an electrosurgical burn.

Multicenter investigation of coronary stenting to treat acute or threatened closure after percutaneous transluminal coronary angioplasty: clinical and angiographic outcomes.

OBJECTIVES: This study reports on the initial experience with the Gianturco-Roubin flexible coronary stent. The immediate and 6-month efficacy of the device and the incidence of the complications of death, myocardial infarction, emergency coronary artery bypass surgery and recurrent ischemic events are presented. BACKGROUND: Abrupt or threatened vessel closure after coronary angioplasty is associated with increased risk of myocardial infarction, emergency coronary artery bypass graft surgery and in-hospital death. When dissection or prolapse of dilated plaque into the lumen is unresponsive to additional or prolonged balloon catheter inflation, coronary stenting offers a nonsurgical mechanical means to rapidly restore stable vessel geometry and adequate coronary blood flow. METHODS: From September 1988 through June 1991, 518 patients underwent attempted coronary stenting with the 20-mm long Gianturco-Roubin coronary stent for acute or threatened vessel closure after angioplasty. In 494 patients, one or more stents were deployed. Thirty-two percent of patients received stents for acute closure and 69% for threatened closure. RESULTS: Successful deployment was achieved in 95.4% of patients. Overall, stenting resulted in an immediate angiographic improvement in the diameter stenosis from 63 +/- 25% before stenting to 15 +/- 14% after stenting. Emergency coronary artery bypass graft surgery was required in 4.3% (21 of 493 patients). The incidence of in-hospital myocardial infarction (Q wave and non-Q wave) was 5.5% (27 of 493 patients). At 6 months, myocardial infarction was infrequent, occurring in 1.6% (8 of 493 patients). The incidence of in-hospital death was 2.2% (11 of 493 patients). Late death occurred in 7 patients (1.4%) and 34 patients (6.9%) required later bypass graft surgery. Complications included blood loss, primarily from the arterial access site, and subacute thrombosis of the stented vessel in 43 patients (8.7%). CONCLUSIONS: The early multicenter experience suggests that this stent is a useful adjunct to coronary angioplasty to prevent or minimize complications associated with flow-limiting coronary artery dissections previously correctable only by surgery. Although this study was not randomized, it demonstrated a high technical success rate and encouraging results with respect to the low incidence of emergency coronary artery bypass graft surgery and myocardial infarction.

Evaluation of clearance kinetics of a portal vascular access system.

A portal vascular access system is a totally implantable system composed of a fluid reservoir with an attached catheter. The system provides easy access for the patient who needs a continuous supply of medication or repeated blood sampling. To ensure no obstruction of flow, the system must be flushed to clear the port and catheter, making it important to establish the clearance parameters. These parameters can be obtained by use of a tetrapolar impedance cell to monitor the relative impedance change using two solutions of different impedances to fill and flush the system. The resulting impedance dilution curve allows calculation of time delay, dilution time, clearance time, and clearance volume. This method and resulting data may be used to characterize a portal vascular access system and provide a basis for comparative analysis of newly introduced systems.

Design and evaluation of closed-loop feedback control of minimum temperatures in human intracranial tumours treated with interstitial hyperthermia.

The dynamic nature of blood flow during hyperthermia therapy has made the control of minimum tumour temperature a difficult task. The paper presents initial studies of a novel approach to closed-loop control of local minimum tissue temperatures utilising a newly developed estimation algorithm for use with conductive interstitial heating systems. The local minimum tumour temperature is explicitly estimated from the power required to maintain each member of an array of electrically heated catheters at a known temperature, in conjunction with a new bioheat equation-based algorithm to predict the 'droop' or fractional decline in tissue temperature between heated catheters. A closed loop controller utilises the estimated minimum temperature near each catheter as a feedback parameter, which reflects variations in local blood flow. In response the controller alters delivered power to each catheter to compensate for changes in blood flow. The validity and stability of this estimation/control scheme were tested in computer simulations and in closed-loop control of nine patient treatments. The average estimation error from patient data analysis of 21 sites at which temperature was independently measured (three per patient) was 0.0 degree C, with a standard deviation of 0.8 degree C. These results suggest that estimation of local minimum temperature and feedback control of power delivery can be employed effectively during conductive interstitial heat therapy of intracranial tumours in man.

Development of a new technique for explantation of chronic transvenous pacemaker leads: five initial case studies.

Transvenous removal of chronic pacing leads was attempted using a special locking stylet and dilator sheaths. In five initial cases, three of seven leads were infected; six of seven leads were removed. The stylet was inserted into the conductor lumen and locked into the tip to reinforce and control the lead, permitting retraction without stretching the conductor. Sheaths were advanced over the lead to detach and dilate fibrous encapsulation. In one case, force applied exceeded the locking mechanism's strength; no patient complication resulted. It is concluded that transvenous lead removal is facilitated by a locking stylet and dilation of fibrous tissue with sheaths.

Intravascular lead extraction using locking stylets, sheaths, and other techniques.

UNLABELLED: Septicemia necessitates extraction of chronic pacemaker leads. Using locking stylets and sheaths to extract leads via the implantation vein (subclavian, cephalic, or jugular) and maneuvering devices, sheaths, and retrieval baskets via the femoral approach, extraction of 228 leads implanted 5 days to 240 months (mean 55 months) was attempted in 136 patients (mean 62 years) at 34 institutions. In addition to septicemia (9%) and infection (39%), total 48%, indications included prophylaxis/replacement (40%), and other (12%). Seventy-seven leads were atrial, 151 ventricular; 147 were unipolar, 81 bipolar; 96 had silicone insulation, 127 polyurethane, 1 poly/silicone, and 2 undetermined. Fixation included tines or fins (160), screw (40), flange (12), and other (16). One hundred and ninety-four leads were completely extracted, 19 partly extracted, and 15 not extracted. Procedural complications were: torn atrium requiring open heart repair (1), hemothorax requiring a chest tube and blood transfusions (1), subacute hemothorax requiring drainage 18 days after discharge (1), thrombosis treated by drugs (1), and myocardial avulsion without sequela (1). Important observations included the significant training required due to the large number of possible clinical variables, and the need to be prepared for life-threatening cardiovascular complications. With training, procedures done at higher volume and lower volume institutions met with similar success. CONCLUSION: Intravascular lead extraction is a viable technique whose benefits outweigh the risks, given the proper intensive training and open heart surgical backup, and may obviate the need for open heart surgery for lead extraction.

Intravascular lead extraction using locking stylets and sheaths.

Chronic lead extraction using intravascular countertraction techniques was studied in patients with over 65 different lead models including passive and active fixation devices. Indications for removal of 115 leads implanted 5 days to 264 months (mean 58 months) in 62 patients (mean 65 years) included septicemia, subcutaneous tissue infection, preerosion, free-floating lead, lead trapped in valve, too many leads, pain, and vein thrombosis. The superior vena cava (SVC) approach was attempted in 101 leads and was successful in 82 attempts (71% of total leads). The inferior vena cava (IVC) approach via the femoral vein was required to extract 14 (12%) leads inaccessible to the SVC approach and the 19 leads that failed the SVC approach (29% of total leads). The SVC procedure includes a sized stylet locked at the tip and telescoping sheaths advanced over the lead to the heart. An IVC procedure includes placement of a 16 F sheath workstation via a femoral vein into the right atrium. A deflection catheter and Dotter snare in an 11 F sheath were advanced through the workstation into the right atrium. The lead was maneuvered into position, snared, and pulled into the workstation. For both the SVC and IVC approaches, the leads were removed by applying traction on the lead and countertraction with the sheaths. In experienced hands, these techniques have proven safe and effective for removing chronic transvenous leads.

Theoretical basis for controlling minimal tumor temperature during interstitial conductive heat therapy.

This paper describes simulation of steady-state intratumoral temperatures achieved by a simple modality of local heat therapy: interstitial treatment with parallel arrays of warmed, conductive heating elements. During "conductive heating" power is directly deposited only in the interstitial probes. Adjacent tissue is warmed by heat conduction. Simulations of interstitial conductive heating involved solution of the bioheat transfer equation on a digital computer using a finite difference model of the treated tissue. The simulations suggest that when the complete temperature distributions for conductive interstitial hyperthermia are examined in detail, substantial uniformity of the temperature distributions is evident. Except for a thin sleeve of tissue surrounding each heating element, a broad, flat central valley of temperature elevation is achieved, with a well defined minimum temperature, very close to modal and median tissue temperatures. Because probes are inserted directly in tumor tissue, the thin sleeve of overheated tissue would not be expected to cause normal tissue complications. The temperature of the heated probes must be continuously controlled and increased in the face of increased blood flow in order to maintain minimum tumor temperature. However, correction for changes in blood flow is possible by adjusting probe temperature according to a feedback control scheme, in which power dissipation from each probe is the sensed input variable. Conductive interstitial heating with continually controlled probe temperature deserves investigation as a technique for local hyperthermia therapy.

Accuracy and precision of computer-simulated tissue temperatures in individual human intracranial tumours treated with interstitial hyperthermia.

Accurate knowledge of tissue temperature is necessary for effective delivery of clinical hyperthermia in the treatment of malignant tumours. This report compares computer-predicted versus measured intratumoral temperatures in 11 human subjects with intracranial tumours, treated with a conceptually simple 'conductive' interstitial hyperthermia system. Interstitial hyperthermia was achieved by the use of parallel arrays of implanted, electrically heated catheters. The tissue was warmed by thermal conduction and blood convection. Simulation of intratumoral temperatures was achieved by solving a modified bioheat transfer equation on a digital computer using a finite difference method. Comparison of intratumoral temperatures from simulations and measured values differed by about +/- 0.75 degrees C. Further analysis of computed temperature distributions between catheters revealed a rapidly computable relationship between the local minimum tumour temperature and nearby catheter power and temperature that accounts for effects of varying blood flow. These findings suggest that 'on-line' prediction and control of local minimum tumour temperatures are feasible with the conductive interstitial technique.

Hyperthermia catheter implantation and therapy in the brain. Technical note.

For the treatment of malignant gliomas, a technique for implanting hyperthermia catheters was developed that utilized a stereotactic template and head-stabilization frame mounted on a computerized tomography (CT) scanner. Computerized tomography scans were used to measure tumor dimensions and to determine the number, implantation depths, and active heating lengths of the catheters, which were implanted through twist-drill holes while the patient was in the CT room. Heat was subsequently delivered via implanted catheters using a computer-controlled hyperthermia system, which partially compensates for heterogeneous and time-varying tumor blood flow.

Concepts of rate responsive pacing.

Various concepts for measuring (by means of biosensors incorporated into pacemakers) biologic parameters to determine the appropriate pacing rate are reviewed. They are pH, stimulus-to-T-wave interval, blood temperature, intercardiac blood pressure change, venous oxygen saturation, intercardiac impedance (stroke volume, ejection rate, preejection interval), thoracic impedance (respiratory rate, minute volume), R-wave area, and body vibration. Those which have been incorporated in an implantable pacemaker and studied in a significant number of patients include intracardiac blood temperature, respiratory rate, respiratory minute volume, stimulus-to-T-wave interval, and body vibration. Studies of intracardiac impedance, QRS complex area, venous oxygen saturation, and right ventricular pressure are in early stages. Because no single parameter has yet proved to be an ideal indicator of metabolic need, dual-chamber pacemakers, which use atrial rate and body vibration to control pacing rate, and multisensor pacemakers are under development.

Evaluation of the temperature response to exercise testing in patients with single chamber, rate adaptive pacemakers: a multicenter study.

UNLABELLED: Temperature responsive pacemakers were implanted in 45 patients (ages 44 to 90); 31 patients were evaluated by randomized, paired treadmill exercise tests 1 month postimplant. Of 28 males and 17 females, 19 had coronary artery disease; 8 had congestive heart failure. Pacing indications included sinus node disease (26), atrial fibrillation (15), AV block (10), and brady/tachy syndrome (10); some had multiple indications. Blood temperature (every 10 seconds, resolution = 0.004 degrees C) and pacing rate (every minute) were telemetered from the pacemaker. Average heart rate, exercise duration (5.7 min VVI; 6.7 min VVIR), VVIR response time (22 sec), initial temperature drop (0.23 degrees C) and maximum rate of drop (0.65 degrees C/min), temperature rise (0.31 degrees C VVI; 0.38 degrees C VVIR) and rate of rise (0.27 degrees C/min) were studied in a subset of patients. In pacer-dependent patients, average paired increases in exercise duration and heart rate was 56% and 34%, respectively. Including all (31) patients, some with intermittent sinus rhythm, increases were 28% and 9%, respectively. Because exercise duration increased, temperature rise was higher with rate adaptation. Rate adaptation was obtainable in all patients and patients averaged 99 +/- 48 increases above basic pacing rate per day at nominal temperature sensitivity. CONCLUSION: Beneficial rate adaptation is achievable using blood temperature to modify rate in a sensor based system.

Case studies on the effect of exercise and hot water submersion on intracardiac temperature and the performance of a pacemaker which varies pacing rate based on temperature.

The effectiveness of using blood temperature change as an indicator to automatically vary heart rate physiologically was evaluated in 3 patients implanted with Model Sensor Kelvin 500 (Cook Pacemaker Corporation, Leechburg, PA, USA) pacemakers. Each patient performed two block-randomized treadmill exercise tests: one while programmed for temperature-based, rate-modulated pacing and the other while programmed without rate modulation. In 1 pacemaker patient and 4 volunteers, heart rates were recorded during exposure to a hot water bath. Blood temperature measured at 10 sec intervals and pacing rate measured at 1 min intervals were telemetered to a diagnostic programmer and data collector for storage and transfer to a computer. Observation comments and ECG-derived heart rates were manually recorded. The temperature-based pacemaker was shown to respond promptly not only to physical exertion but also to emotionally caused stress and submersion in a hot bath. These events cause increased heart rate in the normal heart. Using a suitable algorithm to process the measurement of blood temperature, it was possible to produce appropriate pacing rates in paced patients.

Heart rate correlation, response time and effect of previous exercise using an advanced pacing rate algorithm for temperature-based rate modulation.

A temperature-based algorithm to produce pacing rate that resembles chronotropic response to activity was developed. Measurement criteria for the algorithm included workload dependent rate increases with activity and response time within 60 seconds of exercise onset. To evaluate the algorithm, right ventricular blood temperature was recorded during rest and treadmill exercise in 25 patients with implanted Kelvin 500 pacemakers (Cook Pacemaker). Patients included 16 males and nine females, ages 44-81 (mean 72). Indications for pacing were sinus node disease, atrioventricular block and atrial fibrillation with slow ventricular response. Temperature changes reflected physical activity as well as emotional stress. The algorithm was based on the rate of change (dT/dt), the relative change (delta T) and the baseline history (T) of temperature. At exercise onset, a rapid, brief drop in temperature (dT/dt) typically occurred due to peripheral vasodilation, causing prompt increase in pacing rate. As exercise continued, the increase in metabolic rate caused dT/dt as well as delta T to increase, further increasing pacing rate. After exercise, temperature returned to resting level which correspondingly decreased the pacing rate. Sensitivity of the algorithm to temperature variations, and the upper and lower pacing rate limits were programmable to adapt to individual patient needs. The rates produced by the algorithm mimicked intrinsic rate response for various activity levels and produced a mean response time of 16 seconds from exercise onset. Previous exercise had no significant effect on response time. Correlation between normal chronotropic response and simulated pacing rate from five exercise tests was 0.92. These results show good specificity and refute the statement that blood temperature yields a slow response.