Defibrillator therapy 1997. Prerequisites--results--prospects

BACKGROUND: The first human cardioverter defibrillator implant was performed in 1980. Since then, significant technological improvement has been performed and today, ICDs with multiple diagnostic and therapeutic features are available. We report on 541 patients who underwent ICD implantation between January 1984 and March 1997. Epicardial ICD implant was performed in 209 patients (39%) and 332 patients (61%) received transvenous ICDs. PATIENTS AND RESULTS: Perioperative mortality was 2% (13 patients), significantly more frequent after epicardial (12/209 patients, 6%) than after transvenous implantation (1/332 patients) (p < 0.01). During a mean follow-up of 28 +/- 23 months, 104 patients died (20%), 15 of them (3%) suddenly. 8407 arrhythmic episodes were observed and terminated by antitachycardia pacing in 6655 (79%). Infections occurred in 13 patients (2%), electrode complications in 43 patients (8%) and inappropriate shocks in 84 patients (16%). CONCLUSION: The ICD is an effective approach to treat patients with life-threatening ventricular tachyarrhythmias leading to a low incidence of sudden death. Today, there is a low operative risk and modern ICDs have multiple diagnostic and therapeutic features that allow individual ICD therapy.     

Additional lead improves defibrillation efficacy with an abdominal 'hot can' electrode system

BACKGROUND: Although the left prepectoral site is preferred for "hot can" placement, this site is unavailable in some patients. We evaluated the influence of electrode location on defibrillation thresholds with alternative hot can and transvenous lead configurations. METHODS AND RESULTS: Three interrelated studies were performed. In group 1, the importance of hot can location was investigated by pairing a right ventricular lead to five different hot can placement sites in seven pigs. The defibrillation energies for right pectoral, left pectoral, left subaxillary, and right and left abdominal hot can sites were 20.3+/-2.7,* 15.9+/-3.8, 14.9+/-2.5, 32.0+/-3.4,* and 30.0+/-3.4 J,* respectively (*P<.005 versus left pectoral and left subaxillary sites). In group 2, the value of a three-electrode configuration with an abdominal hot can placement was investigated by adding a subclavian vein lead to the pectoral or abdominal hot can configurations in seven pigs. The defibrillation energies for left pectoral and abdominal sites were 18.6+/-4.2 and 29.0+/-5.8 J (P=.0001), respectively. The addition of a right or left subclavian vein lead with an abdominal hot can reduced the threshold to 19.3+/-4.2* or 18.8+/-3.2,* respectively (*P=.0001 versus abdominal site). In group 3, the contribution of the abdominal hot can electrode to the three-electrode configuration was tested by a comparison with two purely transvenous two-electrode configurations in six pigs. The defibrillation energy (19.9+/-3.2 J) for the abdominal hot can with a subclavian vein lead was lower than the transvenous lead configurations with a subclavian vein (29.0+/-2.5 J, P=.0001) or a superior vena cava lead (30.7+/-3.7 J, P=.0001). The right ventricular lead was the sole cathode during the first phase of the biphasic shock in all experiments. CONCLUSIONS: Defibrillation energy depends on the hot can placement site. The addition of a subclavian vein lead with an abdominal hot can improves defibrillation efficacy to the level of the pectoral placement and is better than a purely transvenous lead configuration.     

Agonist action at D2(long) dopamine receptors: ligand binding and functional assays

Clinical pathways are being introduced by hospitals to reduce costs and control unnecessary variation in care. We studied 766 inpatients to measure the impact of a perioperative clinical pathway for patients undergoing knee replacement surgery on hospital costs. One hundred twenty patients underwent knee replacement surgery before the development of a perioperative clinical pathway, and 63 patients underwent knee replacement surgery after pathway implementation. As control groups, we contemporaneously studied 332 patients undergoing radical prostatectomy (no clinical pathway in place for these patients) and 251 patients undergoing hip replacement surgery without a clinical pathway (no clinical pathway and same surgeons as patients having knee replacement surgery). Total hospitalization costs (not charges), excluding professional fees, were computed for all patients. Mean (+/-SD) hospital costs for knee replacement surgery decreased from $21,709 +/- $5985 to $17,618 +/- $3152 after implementation of the clinical pathway. The percent decrease in hospitalization costs was 1.56-fold greater (95% confidence interval 1.02-2.28) in the knee replacement patients than in the radical prostatectomy patients and 2.02-fold greater (95% confidence interval 1.13-5.22) than in the hip replacement patients. If patient outcomes (e.g., patient satisfaction) remain constant with clinical pathways, clinical pathways may be a useful tool for incremental improvements in the cost of perioperative care. Implications: Doctors and nurses can proactively organize and record the elements of hospital care results in a clinical pathway, also known as "care pathways" or "critical pathways." We found that implementing a clinical pathway for patients undergoing knee replacement surgery reduced the hospitalization costs of this surgery.     

Late complications in patients with pectoral defibrillator implants with transvenous defibrillator lead systems: high incidence of insulation breakdown

As the majority of ICDs with transvenous leads are now implanted in the pectoral region, complications associated with the technique are being identified. To determine the incidence of lead complications in patients with transvenous defibrillator leads and ICDs implanted in the pectoral region, 132 unselected consecutive patients with transvenous defibrillator leads had ICDs implanted in the pectoral region. Three lead systems were used: (1) lead system 1 (45 patients) consisted of a transvenous pacing sensing lead and a superior vena cava coil with a submuscular patch used for defibrillation; (2) lead system 2 (36 patients) utilized a CPI Endotak lead system; and (3) lead system 3 (51 patients) utilized a Medtronic Transvene lead system. Patients were followed for 3-54 months (cumulative 2,269, mean 18 months). The average duration of follow-up with the three systems was 32, 12 and 11 months, respectively. At 30 months follow-up, all three lead systems had a low incidence of complications. However, there was a 13% overall incidence (45% actuarial incidence) of erosion of the insulation of the pacing sensing lead of system 1 at 50 months of follow-up. All lead complications were seen in patients with ICDs whose weights were > 195 g and volumes > 115 cc. The erosion was probably a consequence of the pressure by the large ICD against the lead in the pectoral pocket. Follow-up with lead systems 2 and 3 is relatively short (average 12 months) but no lead erosions were seen. Pectoral implantation of ICDs with long transvenous leads and large generators is associated with a moderate risk of late complications in the form of insulation breaks caused by pressure of the generator against the leads. The use of less redundant leads coupled with smaller ICDs will probably eliminate this complication.     

RB protein status and chemosensitivity in non-small cell lung cancers

A total of 1,207 patients received a Medtronic Jewel active can ICD (models 7218C, 7219C), with a Transvene lead in 97 centers in Europe and North America. Nineteen implants were from the right pectoral region. Patients with right-sided ICDs did not differ in terms of mean age, % male, left ventricular ejection fraction, New York Heart Association Functional Class, antiarrhythmic drug therapy, indication for the implantable cardioverter defibrillator, and R wave values at implantation, but tended to have slightly higher pacing thresholds (1.2 +/- 0.5 V vs 1.0 +/- 0.6 V, P = 0.012) and higher defibrillation thresholds (14.7 +/- 6.4 J vs 11.5 +/- 6 J, P = 0.11) compared with patients with left sided implants. Patients with right-sided implants had a longer implantation time compared with patients with left-sided implants (118 +/- 70 minutes vs 91 +/- 46 minutes, P = 0.074). In follow-up, 5 patients with right-sided implantation received successful therapy for either ventricular fibrillation, (8 episodes) or ventricular tachycardia (5 episodes). No ineffective therapy from the device was delivered in any patients with right-sided implantation. Right-sided pectoral implants are feasible with the Medtronic Jewel active can ICD.     

Preoperative amiodarone as prophylaxis against atrial fibrillation after heart surgery

BACKGROUND: Atrial fibrillation occurs commonly after open-heart surgery and may delay hospital discharge. The purpose of this study was to assess the use of preoperative amiodarone as prophylaxis against atrial fibrillation after cardiac surgery. METHODS: In this double-blind, randomized study, 124 patients were given either oral amiodarone (64 patients) or placebo (60 patients) for a minimum of seven days before elective cardiac surgery. Therapy consisted of 600 mg of amiodarone per day for seven days, then 200 mg per day until the day of discharge from the hospital. The mean (+/-SD) preoperative total dose of amiodarone was 4.8+/-0.96 g over a period of 13+/-7 days. RESULTS: Postoperative atrial fibrillation occurred in 16 of the 64 patients in the amiodarone group (25 percent) and 32 of the 60 patients in the placebo group (53 percent) (P=0.003). Patients in the amiodarone group were hospitalized for significantly fewer days than were patients in the placebo group (6.5+/-2.6 vs. 7.9+/-4.3 days, P=0.04). Nonfatal postoperative complications occurred in eight amiodarone-treated patients (12 percent) and in six patients receiving placebo (10 percent, P=0.78). Fatal postoperative complications occurred in three patients who received amiodarone (5 percent) and in two who received placebo (3 percent, P= 1.00). Total hospitalization costs were significantly less for the amiodarone group than for the placebo group ($18,375+/-$13,863 vs. $26,491+/-$23,837, P=0.03). CONCLUSIONS: Preoperative oral amiodarone in patients undergoing complex cardiac surgery is well tolerated and significantly reduces the incidence of postoperative atrial fibrillation and the duration and cost of hospitalization.     

Can amiodarone pulmonary toxicity be predicted in patients undergoing implantable cardioverter defibrillator implantation?

Implantable cardioverter defibrillator (ICD) implantation is rapidly becoming accepted as primary therapy for malignant ventricular arrhythmias. Many patients undergoing ICD implantation are on concomitant antiarrhythmic drugs to decrease shock frequency, slow tachycardia rate, and suppress supraventricular arrhythmias. Amiodarone is a potent antiarrhythmic agent that is also frequently used in the treatment of patients with refractory ventricular arrhythmias. Ten to forty percent of patients undergoing ICD implantation will also be taking amiodarone. It has been reported to cause pulmonary toxicity in about 5% of patients per year. Acute amiodarone toxicity presenting as adult respiratory distress syndrome has been reported much less frequently. Although perioperative morbidity due to amiodarone has been described, the risk, predictability, and consequences of acute pulmonary toxicity from amiodarone in patients undergoing ICD implantation have not been previously described. We reviewed the records of 99 consecutive patients undergoing ICD implantation at our institution from October 1987 to April 1992. Thirty-nine patients were taking 480 +/- 230 mg of amiodarone (median 400 mg, lower 20th percentile 400 mg, upper 80th percentile 800 mg) for 291 +/- 554 days prior to ICD implantation. Ten patients taking amiodarone developed acute pulmonary toxicity clinically manifesting as diffuse pulmonary infiltrates on chest radiography and adult respiratory distress syndrome with hypoxia (arterial pO2 < 60 mmHg) without evidence of pneumonia or elevated pulmonary capillary wedge pressure (PCW < or = 15 mmHg). Of the 60 patients not taking amiodarone none developed adult respiratory distress syndrome.(ABSTRACT TRUNCATED AT 250 WORDS)     

Complications associated with pectoral cardioverter-defibrillator implantation: comparison of subcutaneous and submuscular approaches. Worldwide Jewel Investigators

OBJECTIVES: The aim of this study was to compare complications in a large cohort of patients undergoing pectoral cardioverter-defibrillator implantation with a subcutaneous or submuscular approach. BACKGROUND: Pectoral placement of implantable cardioverter-defibrillator (ICD) pulse generators is now routine because of downsizing of these devices. subcutaneous implantation has been advocated by some because it is a simple surgical procedure comparable to pacemaker insertion. Others have favored submuscular insertion to avoid wound complications. These surgical approaches have not been compared previously. METHODS: The subjects for this study were 1,000 consecutive patients receiving a Medtronic Jewel ICD at 93 centers worldwide. Cumulative follow-up for all patients was 633.7 patient-years, with 64.9% of patients followed up for > or = 6 months. The complications evaluated were erosion, pocket hematoma, seroma, wound infection, dehiscence, device migration, lead fracture and dislodgment. RESULTS: Subcutaneous implantation was performed in 604 patients and submuscular implantation in the remaining 396. The median procedural times were shorter for subcutaneous implantation (p = 0.014). In addition, the cumulative percentage of patients free from erosion was greater for subcutaneous implantations (p = 0.03, 100% vs. 99.1% at 6 months). However, lead dislodgment was more common with subcutaneous implantations (p = 0.019, 2.3% vs. 0.5% at 6 months) and occurred primarily during the first month postoperatively. Overall, there were no significant differences in cumulative freedom from complications between groups (4.1% vs. 2.5%, p = 0.1836). CONCLUSIONS: Subcutaneous pectoral implantation of this ICD can be performed safely and has a low complication rate. This approach requires a simple surgical procedure and, compared with the submuscular approach, is associated with shorter procedure times and comparable overall complication rates. However, early follow-up is important in view of the increased lead dislodgment rate.     

Characteristics related to STD/HIV in men working in Mexico City bars where female prostitution takes place

Today, we are facing an exponential increase in implantation of cardioverter defibrillators (ICD). The intraoperative and follow-up results are reported in 105 patients (pts) with ventricular tachyarrythmias who underwent ICD implantation in the catheterization laboratory. Fifty-seven pts (54%) hat their first ICD implant (G 1), whereas 46 pts (44%) underwent pulse generator replacement or electrode revision (2 pts, 2%) (G 2). In all pts, ICD implant or pulse generator replacement was performed under general anesthesia from the beginning. In 57/58 pts (98%) in G 1, ICD implantation was possible with a mean defibrillation threshold (DFT) of 13 +/- 8 joules. One patient hat a DFT of > 25 joules and ICD implantation was not achieved. This patient underwent epicardial lead implantation 1 day later. One patient in G 1 had a vessel rupture (v. subclavia) intraoperatively. During a mean follow-up of 5 +/- 2 (< 1-13) months, three pts (3%) died from congestive heart failure, 2, 4 and 6 months after device implantation. An infection occurred in 1 patient in G 2, 3 months after generator replacement. Our data show that in the majority of patients ICD implantation in the cath-lab is possible, safe, and the complication rate is low. Therefore, ICD implantation in the cath-lab can generally be recommended.     

Short-term and long-term outcome of left heart function after cardioverter defibrillator implantation

The usefulness and problems of implantable cardioverter defibrillators (ICD) were examined in patients with reduced heart function. Of 36 patients who received ICD for refractory ventricular tachycardia (VT) or ventricular fibrillation (VF), VT and/or VF was associated with underlying heart disease in 26 patients, and VF without underlying heart disease in 10. Of the former 26 patients, 13 with left ventricular ejection fraction (LVEF) of less than 30% were assigned to group A, 13 with LVEF of greater than 30% to group B, and the other 10 with idiopathic VF to group C. Intraoperative death, cardiac death due to heart failure, sudden death, functional status of the ICD, exacerbation of heart failure symptoms and complications were compared between the three groups. There were no intraoperative deaths in any of the groups. During the median follow-up period of 36 +/- 22 months, there was only one sudden death in group A. There were no significant differences between the three groups. There were five cardiac deaths in group A, but none in groups B or C. The cardiac death-free rates 12, 24, and 36 months after implantation in group A were 83%, 60% and 50%, respectively. These values significantly differed from those in groups B and C (p < 0.05). The number of patients who received defibrillation therapy was higher in group A (p < 0.05). Defibrillation therapy was administered earlier in group A than in groups B and C (p < 0.05). The incidence of exacerbation of heart failure after implantation was 69%, 23% and 0% in groups A, B, and C, respectively. In group A, defibrillation therapy was administered in all patients with exacerbation of heart failure. The administration of defibrillation therapy significantly differed from that in patients without exacerbation of heart failure (p < 0.05). Exacerbation of heart failure during the postoperative acute stage occurred in both patients in group A in whom an epicardial lead system was used, but not in the four patients in group B or five in group C (p < 0.05). There were no differences in the incidence of other complications between the three groups. In group A, patients with reduced heart function, ICD greatly decreased the risk of sudden death. However, heart failure mortality remained high. Therefore, ICD may have limitations for improved prognosis. In group A patients, defibrillation therapy was administered in all patients with exacerbation of heart failure or death due to heart failure. In patients with reduced heart function, treatment for heart failure and prophylaxis of VT and/or VF should be administered.     

The quality of life after the implantation of a cardioverter/defibrillator in malignant arrhythmias

Quality of life after implantation of an automatic implantable cardioverter/defibrillator (ICD) was assessed by questionnaire in 43 patients (38 males, 5 females; mean age 57 +/- 16 years) with treatment-resistant symptomatic ventricular arrhythmias. 37 of the 43 patients felt better after ICD implantation. 23 were always conscious of having an ICD, but 18 had got used to it in less than 2 months. 15 patients reported being afraid of an ICD shock, while eight noted physical discomfort caused by the ICD. Limitations concerning their professional, recreational and social activities were reported by six patients. 41 of the 43 patients confirmed that the ICD had been helpful, enabling 23 to return to an active life. 42 would recommend implantation to others if indicated. These data demonstrate that there is a remarkably high degree of acceptance of the ICD. Survival rate after implantation is thus not the only criterion of success. All aspects of the quality of life should be taken into consideration before implantation is decided upon.     

Comparison of immunodot and western blot assays for diagnosing Lyme borreliosis

Device-based testing of single-lead pectoral defibrillators (defibrillation efficacy testing without an external defibrillation system after complete implantation of the device) resulted in an adequate defibrillation threshold (< or = 20 J) in 45 of 50 study patients (90%). Mean surgical implantation time (skin to skin) was 62 +/- 29 minutes without perioperative mortality and without implantable cardioverter defibrillator infection during follow-up. Thus, device-based testing appears to be a simple and safe method to test defibrillation efficacy of single-lead pectoral defibrillators.     

Local treatment of abdominal wound reduces tumor implantation

BACKGROUND AND OBJECTIVES: Pneumoperitoneum increases the trocar-site tumor implantation rate using a human colon cancer cell line in a hamster model. The purpose of this study was to determine whether local treatment of trocar sites with potential tumoricidal agents can inhibit tumor implantation after pneumoperitoneum. METHODS: GW-39 human colon cancer cells (0.5 ml of 2.5% v/v; 8.0 x 10(5) cells) were injected throughout the abdomen of 133 Golden Syrian hamsters through a midline incision. The animals were randomized to receive either untreated 5-mm trocars in each abdominal quadrant (group I control, n = 49), trocars dipped in 10% povidone-iodine (group II, n = 53), or trocars coated with 1% silver sulfadiazine (group III, n = 51). The midline wounds were also coated with the respective agents before closing. Pneumoperitoneum was then maintained at 10 mmHg for 10 min, after which the trocar wounds were closed. In group II, the trocar sites were treated with a coat of povidone-iodine after the trocars were withdrawn and before closing. Gross and microscopic tumor implants were analyzed at 7 weeks postoperatively. RESULTS: The rate of tumor cell implantation at trocar sites was reduced from 93% (172/184) in the control group to 75% (126/168) and 78% (141/180) in groups II and III, respectively (P < 0.0001). Fewer palpable tumors were detected in groups II and III (40% and 23%, respectively) than in the control group (72%, P < 0.0001). Mean tumor mass in group III (0.4+/-0.1 g), but not in group II (1.0+/-0.2 g), was significantly less than that in the control group (1.3+/-0.1 g, P < 0.01). Overall tumor involvement of the larger midline wound was similar for all groups (I = 80%, II = 79%, III = 71%). However, palpable tumors were identified more frequently in group I (67%) than in groups II and III (43%, P < 0.05; 22%, P < 0.01, respectively). CONCLUSION: Pretreatment of abdominal wounds with povidone-iodine or silver sulfadiazine can reduce tumor implantation after pneumoperitoneum in a hamster model.     

Early evacuation of traumatic retained hemothoraces using thoracoscopy: a prospective, randomized trial

BACKGROUND: Failure to adequately evacuate blood from the pleural space after trauma may result in extended hospitalization and complications such as empyema. METHODS: Patients with retained hemothoraces were prospectively randomized to either a second tube thoracostomy (group 1, n = 24) or video-assisted thoracoscopy (VATS) (group 2, n = 15). Group 1 patients in whom additional tube drainage failed were subsequently randomized to either VATS or thoracotomy. Study end points included duration and costs of hospitalization. RESULTS: During a 4-year period, 39 patients were entered into the study. Patients in group 2 had shorter duration of tube drainage (2.53 +/- 1.36 versus 4.50 +/- 2.83 days, mean +/- standard deviation; p < 0.02), shorter hospital stay after the procedure (3.60 +/- 1.64 versus 7.21 +/- 5.30 days; p < 0.02), and shorter total hospital stay (5.40 +/- 2.16 versus 8.13 +/- 4.62 days; p < 0.02). Hospital costs were also less in this group ($7,689 +/- 3,278 versus $13,273 +/- 8,158; p < 0.02). There was no mortality in either group. No group 2 patient required conversion to thoracotomy. In 10 group 1 patients additional tube placement failed, and this subset was randomized to VATS (n = 5) or thoracotomy (n = 5). No significant difference in clinical outcome was found between these subgroups. CONCLUSIONS: In many patients treated only with additional tube drainage (group 1), this therapy fails, necessitating further intervention. Intent to treat with early VATS for retained hemothoraces decreases the duration of tube drainage, the length of hospital stay, and hospital cost. Early intervention with VATS may be a more efficient and economical strategy for managing retained hemothoraces after trauma.     

Decrease in isoflurane requirements and of postoperative pain with preanesthetic intrathecal morphine

OBJECTIVES: 1) To determine whether preanesthetic intrathecal administration of 0.5 mg morphine reduces isoflurane requirements for anesthetic maintenance. 2) To assess the duration of postoperative analgesia and the type and frequency of complications attributable to the procedure. PATIENTS AND METHODS: A series of 45 adults were distributed into 3 groups of 15 patients each based on site of surgery and site of preanesthetic (30 min) injection of 0.5 mg pure morphine. Control group (C0) patients underwent lumbar surgery and received subcutaneous morphine. Group C0.5 patients also underwent lumbar surgery but received intrathecal morphine. Group A0.5 patients underwent long-duration high abdominal surgery and received intrathecal morphine. Anesthesia was maintained with nitrous oxide (60%) in oxygen (40%) and a variable concentration of isoflurane. Isoflurane needs were assessed by averaging six consecutive measurements of end-tidal isoflurane pressure (M30FETiso) taken at intervals of 5 min. Postoperative analgesia was evaluated by means of a visual analog scale that was converted to numerical units (VASn). RESULTS: M30FETiso in group C0 (0.8%) was always higher (p < 0.01) than in the other two groups. M30FETiso in group A0.5 was higher (p < 0.01) than in group C0.5 during the first 150 min of surgery. After 180 min, there were no differences in M30FETiso (0.10-0.16%) between the two groups receiving intrathecal morphine. VASn results (mean +/- SD) in the first 4 hours were higher in group C0 (7.33 +/- 0.6) than in group C0.5 (1.13 +/- 0.35) and group A0.5 (1.07 +/- 0.26). The time of morphine-dependent analgesia was shorter (p < 0.01) in group C0 (0.62 +/- 0.38 hours) than in groups C0.5 (30.4 +/- 5.11 hours) and A0.5 (28 +/- 4.34 hours). There were no significant differences between the two groups receiving intrathecal morphine. CONCLUSIONS: Preanesthetic subarachnoid lumbar injection of 0.5 mg of pure morphine reduced early requirements for isoflurane in lumbar surgery (0.14% after 60 min). This reduction was initially less in patients undergoing abdominal surgery (0.44% at 60 min) but was the same after 150 min. Postoperative analgesia was long-term and independent of type or duration of surgery. There was no respiratory depression after surgery and the incidence of postoperative complications was similar in the two groups that received subarachnoid morphine.     

Hepatoblastoma in a dog

BACKGROUND: In neonates and infants epicardial stimulation may be preferred to endocardial stimulation because of growth-associated lead problems and the risk of vascular complications associated with transvenous electrodes. This study analyzes the feasibility of atrioventricular implantation of a new epicardial lead using the video-assisted thoracic surgical (VATS) technique in an animal model. METHODS: Bipolar steroid-eluting epicardial leads were implanted in seven young white pigs. In five animals bipolar atrial and ventricular pacing leads (n = 10) were inserted and fixed by the VATS technique, while two animals served as controls and underwent implantation through anterolateral thoracotomy. Surgical feasibility, pacing, and sensing thresholds of the leads as well as hemodynamic parameters during pacing were studied. Histological changes beneath the electrodes were evaluated 1 week after the implantation. RESULTS: All animals survived the pacemaker lead implantation. One animal which underwent thoracotomy died because of irreversible ventricular fibrillation induced by rapid ventricular pacing. One animal in the VATS group exhibited intraoperative herniation of the heart through the pericardial window. All animals with left-sided VATS implantations demonstrated good individual pacing and sensing threshold values. The mean cardiac output was 1.6 times higher during AAI-mode pacing as compared to VVI-mode pacing at a heart rate of 140/min. One animal died postoperatively due to respiratory failure. No displacements of the pacemaker leads were observed in the survivors. CONCLUSION: While VATS-guided implantation of epicardial, atrial, and ventricular leads is feasible, technical improvements of the system are mandatory for safe clinical application.     

Favorable results of implantable cardioverter-defibrillator implantation in patients older than 70 years

BACKGROUND: The clinical results of implantable cardioverter-defibrillator (ICD) implantation in the elderly have received limited documentation. As the longevity of the U.S. population has increased, so has the need for ICD implantation in the elderly. We evaluated the efficacy and outcome of ICD implantation in elderly patients (>70 years) compared with younger patients. METHODS: The case records of all consecutive patients who underwent ICD implantation at our institution between 1986 and 1994 were reviewed. Of a total of 238 patients, 78 patients were 70 years of age or older and 160 patients were younger than 70 years of age. RESULTS: The mean age of the younger group was 58 years and that of the elderly group was 74 years. There were no statistical differences in the presence of coronary artery disease, left ventricular systolic function, the inducibility of arrhythmias, or the history of sudden cardiac death. The hospital morbidity rate was similar in both groups (6.9% in the younger group and 7.7% in the elderly group; p = not significant). The operative mortality rate was 1.9% for the younger group and 1.3% for the elderly group (p = not significant). At a mean follow-up of 33 +/- 26 months, Kaplan-Meier survival curves demonstrated similar survival rates, with 93%, 82%, and 65% of the patients alive at 1, 3, and 6 years, respectively. CONCLUSIONS: Implantable cardioverter-defibrillator implantation was equally effective in the treatment of patients older than 70 years as in younger patients. No differences in theoretic survival or morbidity were observed.     

Incidence of leukemia in Krakow in the period 1980-1990]

OBJECTIVE: This study was done to compare costs, operating and recovery times, safety, and patient acceptance between (a) minimally invasive laparoscopic tubal ligation under sedation and local anesthesia and (b) conventional laparoscopic operating-room-based tubal ligations under general anesthesia. METHODS: Fourteen women desiring sterilization were randomized between tubal ligation under sedation/local analgesia versus general anesthesia. Procedures were performed by supervised residents previously unfamiliar with the minimally invasive technique. Hospital charges were used as a surrogate for cost. Operating or procedure room times, surgical complications, and recovery times were recorded. Patient acceptance was assessed using satisfaction surveys administered in the recovery room and again 1 week postoperatively. RESULTS: The cost of minimally invasive tubal ligation was significantly lower than for the conventional technique ($1,615+/-$134 vs $2,820+/-$110, p < 0.001). Surgical times were not different between the two procedures: 40.4+/-15 min for the conventional technique versus 32.9+/-10 min for minimally invasive surgery. However, the total in-room time required in the operating room significantly exceeded that for the procedure room technique (84+/-10 min vs 60+/-2 min, p < 0.05). Likewise, recovery time for the general anesthesia technique was longer (48+/-6 min vs 14+/-7 min, p < 0.03). No complications were encountered with either surgical method. Patient satisfaction for pain, fatigue, and days of missed work was similar between the two groups. CONCLUSIONS: The use of minimally invasive surgery to perform tubal ligation is advantageous over conventional laparoscopic tubal ligation under general anesthesia with regard to cost and time utilization. The minimally invasive technique appears to be easy to learn, safe, and well tolerated.     

Protective effect of preservation of canine pancreas by the two-layer (University of Wisconsin solution/perfluorochemical) method against rewarming ischemic injury during implantation

Rewarming ischemia during implantation severely compromises posttransplant pancreas graft survival because the graft has already been subjected to warm and cold ischemia before implantation. The purpose of this study was to examine whether preservation of the pancreas graft by the two-layer method ameliorates rewarming ischemic injury of the graft during implantation using a canine model. After flushing with cold University of Wisconsin solution (UW), the pancreas grafts were preserved by the two-layer (UW/perfluorochemical [PFC]) method (group 1) or simple cold storage in UW (group 2) for 24 hr and then autotransplanted. In control, the pancreas grafts were flushed out with cold UW and immediately autotransplanted without preservation (group 3). After completion of vascular anastomosis, vascular clamp was not released until 90, 120, or 150 min of rewarming ischemia, including anastomosis time, had elapsed. After 90 min of rewarming ischemia, graft survival rates were 5/5, 100%, 5/5, 100%, and 5/5, 100%, in groups 1, 2, and 3, respectively. After 120 min, all the grafts in groups 2 and 3 failed (0/5, 0%, and 0/5, 0%, respectively); however, all the grafts in group 1 survived (5/5, 100%). Even after 150 min, 1 of 3 grafts in group 1 survived (1/3, 33%). After 24 hr preservation, tissue ATP levels of the grafts in group 1 were about 2-fold the reference values before harvesting (8.23 +/- 0.72 vs. 4.44 +/- 0.49 mumol/g dry weight, P < 0.05) and significantly higher compared with group 2 (8.23 +/- 0.72 vs. 1.76 +/- 0.52 mumol/g dry weight, P < 0.01). After 120 min of rewarming ischemia, tissue ATP levels in group 1 were 84% of the reference values and significantly higher compared with group 2 (3.75 +/- 0.25 vs. 1.57 +/- 0.48 mumol/g dry weight, P < 0.05). Two hours after reperfusion, ATP levels in group 1 were 42% of reference values but significantly higher compared with group 2 (1.86 +/- 0.36 vs. 1.03 +/- 0.18 mumol/g dry weight, P < 0.05). We conclude that the two-layer (UW/PFC) method ameliorates rewarming ischemic injury of the pancreas graft during implantation by increasing tissue ATP contents during preservation and consequently maintaining tissue ATP levels during implantation.     

Risk factors for higher cost in congenital heart operations

BACKGROUND: For many congenital heart defects, hospital mortality is no longer a sensitive parameter by which to measure outcome. Although hospital survival rates are now excellent for a wide variety of lesions, many patients require expensive and extensive hospital-based services during the perioperative period to enable their convalescence. These services can substantially increase the cost of care delivery. In today's managed care environment, it would be useful if risk factors for higher cost could be identified preoperatively so that appropriate resources could be made available for the care of these patients. The focus of this retrospective investigation is to determine if risk factors for high cost for repair of congenital heart defects can be identified. METHODS: We assessed financial risk by tracking actual hospital costs (not charges) for 144 patients undergoing repair of atrial septal defect (58 patients), ventricular septal defect (48 patients), atrioventricular canals (14 patients), or tetralogy of Fallot (24 patients) at Duke University Medical Center between July 1, 1992, and September 15, 1995. Furthermore, we were able to identify where the costs occurred within the hospital. Financial risk was defined as a large (> 60% of mean costs) standard deviation, which indicated unpredictability and variability in the treatment for a group of patients. RESULTS: Cost for atrial septal defect repair was predictably consistent (low standard deviation) and was related to hospital length of stay. There were factors, however, for ventricular septal defect, atrioventricular canal, and tetralogy of Fallot repair that are identifiable preoperatively that predict low- and high-risk groups using cost as an outcome parameter. Patients undergoing ventricular septal defect repair who were younger than 6 months of age at the time of repair, who required preoperative hospital stays of longer than 7 days before surgical repair, or who had Down's syndrome had a less predictable cost picture than patients undergoing ventricular septal defect repair who were older than 2 years, who had short (< 4 days) preoperative hospitalization, or who did not have Down's syndrome ($48,252 +/- $42,539 versus $15,819 +/- $7,219; p = 0.008). Patients with atrioventricular canals who had long preoperative hospitalization (> 7 days), usually due to pneumonia (respiratory syncytial virus) with preoperative mechanical ventilation had significantly higher cost than patients with atrioventricular canals who underwent elective repair with short preoperative hospitalization ($83,324 +/- $60,138 versus $26,904 +/- $5,384; p = 0.05). Patients with tetralogy of Fallot had higher costs if they had multiple congenital anomalies, previous palliation (combining costs of both surgical procedures and hospital stays), or severe "tet" spells at the time of presentation for operation compared with patients without these risk factors ($114,202 +/- $88,524 versus $22,241 +/- $7,071; p = 0.0005). One patient (with tetralogy of Fallot) with multiple congenital anomalies died 42 days after tetralogy of Fallot repair of sepsis after a gastrointestinal operation. Otherwise, hospital mortality was 0% for all groups. CONCLUSIONS: Low mortality and good long-term outcome for surgical correction of congenital heart defects is now commonplace, but can be expensive as some patients with complex problems receive the care necessary to survive. This study demonstrates that it is possible to identify factors preoperatively that predict financial risk. This knowledge may facilitate implementation of risk adjustments for managed care contracting and for strategic resource allocation.