Saint Joseph's Hospital

BACKGROUND: Pulsed field ablation uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death. Pulsed field ablation may have effectiveness comparable to traditional catheter ablation while preventing thermally mediated complications. METHODS: The PULSED AF pivotal study (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF) was a prospective, global, multicenter, nonrandomized, paired single-arm study in which patients with paroxysmal (n=150) or persistent (n=150) symptomatic atrial fibrillation (AF) refractory to class I or III antiarrhythmic drugs were treated with pulsed field ablation. All patients were monitored for 1 year using weekly and symptomatic transtelephonic monitoring; 3-, 6-, and 12-month ECGs; and 6- and 12-month 24-hour Holter monitoring. The primary effectiveness end point was freedom from a composite of acute procedural failure, arrhythmia recurrence, or antiarrhythmic escalation through 12 months, excluding a 3-month blanking period to allow recovery from the procedure. The primary safety end point was freedom from a composite of serious procedure- and device-related adverse events. Kaplan-Meier methods were used to evaluate the primary end points. RESULTS: Pulsed field ablation was shown to be effective at 1 year in 66.2% (95% CI, 57.9 to 73.2) of patients with paroxysmal AF and 55.1% (95% CI, 46.7 to 62.7) of patients with persistent AF. The primary safety end point occurred in 1 patient (0.7%; 95% CI, 0.1 to 4.6) in both the paroxysmal and persistent AF cohorts. CONCLUSIONS: PULSED AF demonstrated a low rate of primary safety adverse events (0.7%) and provided effectiveness consistent with established ablation technologies using a novel irreversible electroporation energy to treat patients with AF. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04198701.

BACKGROUND: This study evaluated a large group of patients enrolled in a double-blind randomized trial of the sirolimus-eluting stent to document whether the initial clinical improvement seen in previous smaller series is maintained out to 12 months and to study the potential treatment effect in patient subsets known to be at increased risk of restenosis. METHODS AND RESULTS: A total of 1058 patients with de novo native coronary stenosis undergoing clinically indicated percutaneous coronary intervention were randomly assigned to sirolimus-eluting stent (533) or control bare stent (525). Procedural success and in-hospital outcomes were excellent and did not differ between the 2 groups. At 9 months, clinical restenosis, defined as target-lesion revascularization, was 4.1% in the sirolimus limb versus 16.6% in the control limb (P<0.001). At 12 months, the absolute difference in target-lesion revascularization continued to increase and was 4.9% versus 20% (P<0.001). There were no differences in death or myocardial infarction rates. In high-risk patient subsets, defined by vessel size, lesion length, and presence of diabetes mellitus, there was a 70% to 80% reduction in clinical restenosis at 1 year. CONCLUSIONS: Placement of the sirolimus-eluting stent results in continued clinical improvement at 1 year after initial implantation, with significant reduction in clinical restenosis as defined by target-lesion revascularization. Between 9 and 12 months, the absolute reduction of clinical restenosis continues to increase. Even in high-risk subsets of patients, there is a 70% to 80% relative reduction in clinical restenosis at 12 months with this drug-eluting stent.

Importance: Glioblastoma is the most lethal primary brain cancer. Clinical outcomes for glioblastoma remain poor, and new treatments are needed. Objective: To investigate whether adding autologous tumor lysate-loaded dendritic cell vaccine (DCVax-L) to standard of care (SOC) extends survival among patients with glioblastoma. Design, Setting, and Participants: This phase 3, prospective, externally controlled nonrandomized trial compared overall survival (OS) in patients with newly diagnosed glioblastoma (nGBM) and recurrent glioblastoma (rGBM) treated with DCVax-L plus SOC vs contemporaneous matched external control patients treated with SOC. This international, multicenter trial was conducted at 94 sites in 4 countries from August 2007 to November 2015. Data analysis was conducted from October 2020 to September 2021. Interventions: The active treatment was DCVax-L plus SOC temozolomide. The nGBM external control patients received SOC temozolomide and placebo; the rGBM external controls received approved rGBM therapies. Main Outcomes and Measures: The primary and secondary end points compared overall survival (OS) in nGBM and rGBM, respectively, with contemporaneous matched external control populations from the control groups of other formal randomized clinical trials. Results: A total of 331 patients were enrolled in the trial, with 232 randomized to the DCVax-L group and 99 to the placebo group. Median OS (mOS) for the 232 patients with nGBM receiving DCVax-L was 19.3 (95% CI, 17.5-21.3) months from randomization (22.4 months from surgery) vs 16.5 (95% CI, 16.0-17.5) months from randomization in control patients (HR = 0.80; 98% CI, 0.00-0.94; P = .002). Survival at 48 months from randomization was 15.7% vs 9.9%, and at 60 months, it was 13.0% vs 5.7%. For 64 patients with rGBM receiving DCVax-L, mOS was 13.2 (95% CI, 9.7-16.8) months from relapse vs 7.8 (95% CI, 7.2-8.2) months among control patients (HR, 0.58; 98% CI, 0.00-0.76; P < .001). Survival at 24 and 30 months after recurrence was 20.7% vs 9.6% and 11.1% vs 5.1%, respectively. Survival was improved in patients with nGBM with methylated MGMT receiving DCVax-L compared with external control patients (HR, 0.74; 98% CI, 0.55-1.00; P = .03). Conclusions and Relevance: In this study, adding DCVax-L to SOC resulted in clinically meaningful and statistically significant extension of survival for patients with both nGBM and rGBM compared with contemporaneous, matched external controls who received SOC alone. Trial Registration: ClinicalTrials.gov Identifier: NCT00045968.

Importance: Catheter ablation of persistent atrial fibrillation (AF) has limited success. Procedural strategies beyond pulmonary vein isolation have failed to consistently improve results. The vein of Marshall contains innervation and AF triggers that can be ablated by retrograde ethanol infusion. Objective: To determine whether vein of Marshall ethanol infusion could improve ablation results in persistent AF when added to catheter ablation. Design, Setting, and Participants: The Vein of Marshall Ethanol for Untreated Persistent AF (VENUS) trial was an investigator-initiated, National Institutes of Health-funded, randomized, single-blinded trial conducted in 12 centers in the United States. Patients (N = 350) with persistent AF referred for first ablation were enrolled from October 2013 through June 2018. Follow-up concluded in June 2019. Interventions: Patients were randomly assigned to catheter ablation alone (n = 158) or catheter ablation combined with vein of Marshall ethanol infusion (n = 185) in a 1:1.15 ratio to accommodate for 15% technical vein of Marshall ethanol infusion failures. Main Outcomes and Measures: The primary outcome was freedom from AF or atrial tachycardia for longer than 30 seconds after a single procedure, without antiarrhythmic drugs, at both 6 and 12 months. Outcome assessment was blinded to randomization treatment. There were 12 secondary outcomes, including AF burden, freedom from AF after multiple procedures, perimitral block, and others. Results: Of the 343 randomized patients (mean [SD] age, 66.5 [9.7] years; 261 men), 316 (92.1%) completed the trial. Vein of Marshall ethanol was successfully delivered in 155 of 185 patients. At 6 and 12 months, the proportion of patients with freedom from AF/atrial tachycardia after a single procedure was 49.2% (91/185) in the catheter ablation combined with vein of Marshall ethanol infusion group compared with 38% (60/158) in the catheter ablation alone group (difference, 11.2% [95% CI, 0.8%-21.7%]; P = .04). Of the 12 secondary outcomes, 9 were not significantly different, but AF burden (zero burden in 78.3% vs 67.9%; difference, 10.4% [95% CI, 2.9%-17.9%]; P = .01), freedom from AF after multiple procedures (65.2% vs 53.8%; difference, 11.4% [95% CI, 0.6%-22.2%]; P = .04), and success achieving perimitral block (80.6% vs 51.3%; difference, 29.3% [95% CI, 19.3%-39.3%]; P < .001) were significantly improved in vein of Marshall-treated patients. Adverse events were similar between groups. Conclusions and Relevance: Among patients with persistent AF, addition of vein of Marshall ethanol infusion to catheter ablation, compared with catheter ablation alone, increased the likelihood of remaining free of AF or atrial tachycardia at 6 and 12 months. Further research is needed to assess longer-term efficacy. Trial Registration: ClinicalTrials.gov Identifier: NCT01898221.

Background. Rickettsia parkeri rickettsiosis, a recently identified spotted fever transmitted by the Gulf Coast tick (Amblyomma maculatum), was first described in 2004. We summarize the clinical and epidemiological features of 12 patients in the United States with confirmed or probable disease attributable to R. parkeri and comment on distinctions between R. parkeri rickettsiosis and other United States rickettsioses.

The transverse abdominal island flap operation was the method of breast reconstruction after mastectomy and in chest wall reconstruction in 300 patients from September 1980 to July 1986. In 58% (221 of 383 breast reconstructions), the breast mound was formed in a single operation and required no further revision. Only 18 reconstructed breasts required modification after 1 year. Symmetry was achieved without altering the opposite breast in 113 (52% of the 217 unilateral reconstructions). Complications included one total flap loss (0.3%) and 18 partial flap losses (6%). There was one lower abdominal hernia (0.3%) and two small defects in the upper anterior rectus sheath (0.8%). Lower abdominal wall laxity occurred in two patients (0.8%), one requiring repair. As expected, there was some loss of abdominal wall strength after reconstruction but this did not affect sports or work performance in over 90% of patients. Ninety-eight per cent of respondents (272 or 278) judged the operation worth their time and effort. This major operative procedure is indicated only in healthy patients.

OBJECTIVES: The aim of this study was to prospectively evaluate the impact of blood pressure management on stroke rates in patients receiving the HeartWare HVAD System. BACKGROUND: The ENDURANCE trial demonstrated noninferiority of the HeartWare HVAD System versus control (HeartMate II) in patients with advanced heart failure ineligible for heart transplantation. However, stroke was more common in HVAD subjects. Post hoc analyses demonstrated increased mean arterial blood pressure as a significant independent risk factor for stroke. METHODS: The ENDURANCE Supplemental Trial was a prospective, multicenter evaluation of 465 patients with advanced heart failure ineligible for transplantation, randomized 2:1 to HVAD (n = 308) or control (n = 157). The primary endpoint was the 12-month incidence of transient ischemic attack or stroke with residual deficit 24 weeks post-event. Secondary endpoints included the composite of freedom from death, disabling stroke, and need for device replacement or urgent transplantation, as well as comparisons of stroke or transient ischemic attack rates in HVAD cohorts in ENDURANCE Supplemental and ENDURANCE. RESULTS: The enhanced blood pressure protocol significantly reduced mean arterial blood pressure. The primary endpoint was not achieved (14.7% with HVAD vs. 12.1% with control, noninferiority [margin 6%] p = 0.14). However, the secondary composite endpoint demonstrated superiority of HVAD (76.1%) versus control (66.9%) (p = 0.04). The incidence of stroke in HVAD subjects was reduced 24.2% in ENDURANCE Supplemental compared with ENDURANCE (p = 0.10), and hemorrhagic cerebrovascular accident was reduced by 50.5% (p = 0.02). CONCLUSIONS: The ENDURANCE Supplemental Trial failed to demonstrate noninferiority of HVAD versus control regarding the pre-specified primary endpoint. However, the trial confirmed that BP management is associated with reduced stroke rates in HVAD subjects. HVAD subjects, relative to control subjects, more commonly achieved the composite endpoint (freedom from death, disabling stroke, and device replacement or urgent transplantation). (A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System [ENDURANCE SUPPLEMENTAL TRIAL] [DT2]; NCT01966458).

Vasoplegic syndrome is a common occurrence following cardiothoracic surgery and is characterized as a high-output shock state with poor systemic vascular resistance. The pathophysiology is complex and includes dysregulation of vasodilatory and vasoconstrictive properties of smooth vascular muscle cells. Specific bypass machine and patient factors play key roles in occurrence. Research into treatment of this syndrome is limited and extrapolated primarily from that pertaining to septic shock, but is evolving with the expanded use of catecholamine-sparing agents. Recent reports demonstrate potential benefit in novel treatment options, but large clinical trials are needed to confirm.

The critical integration of timing and patterning between respiratory and swallowing events was studied with simultaneous videofluoroscopic and respiratory recording during single liquid swallows. Respiratory phase patterns and the onsets and durations of 12 predetermined swallowing events and associated respiratory activities were studied. Results showed four highly repeatable, temporally oriented sequences (clusters) of swallowing and related respiratory events. Two respiratory phase patterns were identified without statistically significant differences in frequency of occurrence between age, gender, or race. These findings will aid in the identification of normal and abnormal patterns of breathing and swallowing in patients with dysphagia.

Transradial catheterization (TRC) has been associated with a lower incidence of major access site related complications as compared to the transfemoral approach. With the increased adoption of transradial access, it is essential to understand the potential major and minor complications of TRC. The most common complication is asymptomatic radial artery occlusion, which rarely leads to clinical events, owing to the dual collateral perfusion of the hand. Adequate anticoagulation, appropriate compression techniques, and smaller sheath size can minimize the risk of radial artery occlusion. Hand ischemia with necrosis has never been reported during TRC with thorough pre-examination of intact collateral circulation. Radial artery spasm is relatively common, and can result in access and procedural failure. It can be prevented by the use of vasodilator cocktails and hydrophilic sheaths. Radial artery perforation can lead to severe forearm hematoma and compartment syndrome if not managed promptly. Careful observation, prompt detection of the hematoma, and management with a pressure bandage dressing are critical to avoid serious complications. Pseudoaneurym and arteriovenous fistula are rare complications, which can likely be managed conservatively without surgical intervention. Nerve injury occurring during access has been reported. Close observation for improvement is necessary, although symptoms usually improve over time. In summary, to prevent access site complications, avoidance of multiple punctures, gentle catheter manipulation, use of guided compression, coupled with careful observation for adverse warning signs such as hematoma, loss of pulse, pain, are critical for safe and effective TRC.

Mechanical derangements of the lumbar spine, causing predominantly back pain with the absence of nerve root irritation or compromise, present a difficult treatment challenge to the average physician. The author suggests that facet joint injections offer a simple, safe, and often dramatically effective means for managing these problems. The historic background and technique are described in detail. The author presents his personal experience with 99 patients receiving a total of 117 facet joint injections in this retrospective, uncontrolled review. Results were classified as excellent in 17%, good in 25%, fair in 9%, mediocre in 4%, and no change in symptoms occurred in 44%. The procedure is recommended for diagnostic and conservative therapy.

BACKGROUND: Defining risk factors for central venous catheter (CVC)-associated bloodstream infections (BSIs) is critical to establishing prevention measures, especially for factors such as nurse staffing and antimicrobial-impregnated CVCs. METHODS: We prospectively monitored CVCs, nurse staffing, and patient-related variables for CVC-associated BSIs among adults admitted to eight ICUs during 2 years. RESULTS: A total of 240 CVC-associated BSIs (2.8%) were identified among 4,535 patients, representing 8,593 CVCs. Antimicrobial-impregnated CVCs reduced the risk for CVC-associated BSI only among patients whose CVC was used to administer total parenteral nutrition (TPN, 2.6 CVC-associated BSIs per 1,000 CVC-days vs no TPN, 7.5 CVC-associated BSIs per 1,000 CVC-days; P = .006). Among patients not receiving TPN, there was an increase in the risk of CVC-associated BSI in patients cared for by "float" nurses for more than 60% of the duration of the CVC. In multivariable analysis, risk factors for CVC-associated BSIs were the use of TPN in non-antimicrobial-impregnated CVCs (P = .0001), patient cared for by a float nurse for more than 60% of CVC-days (P = .0019), no antibiotics administered to the patient within 48 hours of insertion (P = .0001), and patient unarousable for 70% or more of the duration of the CVC (P = .0001). Peripherally inserted central catheters (PICCs) were associated with a lower risk for CVC-associated BSI (P = .0001). CONCLUSIONS: Antimicrobial-impregnated CVCs reduced the risk of CVC-associated BSI by 66% in patients receiving TPN. Limiting the use of float nurses for ICU patients with CVCs and the use of PICCs may also reduce the risk of CVC-associated BSI.

Thirty-eight traumatic brain injury (TBI) patients who underwent a neuropsychologically oriented milieu rehabilitation program were compared with an historical control group of 38 TBI patients who did not receive this form of rehabilitation. Patients were matched according to admitting Glasgow Coma Scale (GCS) score, age at injury, and gender. Educational level and chronicity of brain injury were not completely matched but were controlled for in statistical analyses. A greater number of TBI patients who received this form of rehabilitation were productive (ie, a student, a worker, or both) compared with the untreated group. A good or excellent working alliance with the rehabilitation staff was significantly related to a positive productivity status. The same finding was observed when assessing the relationship of the working alliance with the patients' families and productivity status. The data support the proposition that specialty neurorehabilitation programs aimed at work reentry may be helpful in a selected group of TBI patients.

Forty-four consecutive patients with segmental debridement defects of the tibia had limb-salvage surgery. Twenty-one patients (Group I) were managed using methods as described by Ilizarov. Twenty-three patients (Group II) underwent conventional treatment with massive cancellous grafts and tissue transfers. Total wound consolidation and infection arrest took place after the first treatment in 71% of the Ilizarov wounds and 74% of the conventionally treated wounds. The major complication rates were 33% and 60% for Groups I and II respectively. The patient population at highest risk for failure was the compromised host treated conventionally (44%). The cost for retreatment and overall success rate (95%) were the same for both groups. Ilizarov reconstructions averaged nine fewer hours in the operating theater, 23 fewer days in the hospital, five fewer months' disability (17 months versus 22 months), and a savings of nearly $30,000 per application.

Although significant technical advances in surgical and radiation treatment for brain tumors have emerged in recent years, their impact on clinical outcome for patients has been disappointing. A fundamental source of the management challenge presented by glioma patients is the insidious propensity of the malignant cells to invade into adjacent normal brain. Invasive tumor cells escape surgical removal and geographically dodge lethal radiation exposure. Recent improved understanding of the biochemistry and molecular determinants of glioma cell invasion provide valuable insight to the underlying biological features of the disease, as well as illuminating possible new therapeutic targets. Heightened commitment to migrate and invade is accompanied by a glioma cell's reduced proliferative activity. The microenvironmental manipulations coincident to invasion and migration may also impact the glioma cell's response to cytotoxic treatments. These collateral aspects of the glioma cell invasive phenotype should be further explored and exploited as novel antiglioma therapies.

Glutathione (GSH) is the major source of intracellular sulfhydryl groups. Oxidized GSH (GSSG) can be recycled to GSH by the GSH reductase or exported from the cell. The mechanism by which GSSG is exported and the consequence of its export from endothelial cells has not been defined previously. We found that human endothelial cells express the multidrug resistance protein-1 (MRP1) and use this as their major exporter of GSSG. Oscillatory shear stress, which is known to stimulate endothelial cell production of reactive oxygen species, decreased intracellular GSH. In contrast, laminar shear significantly increased intracellular GSH. Oscillatory shear also caused a robust export of GSSG that was prevented by the MRP1 inhibitor MK571 and by MRP1 small interfering RNA. MRP1 inhibition prevented the decline in intracellular GSH, preserved the intracellular GSH Nernst potential, and reduced apoptosis caused by oscillatory shear. In aortas of hypertensive mice, endothelial disulfide export was doubled, and this was prevented by MK571 and was not observed in aortas of hypertensive MRP1 −/− mice. Further, the altered endothelium-dependent vasodilatation caused by hypertension was ameliorated in MRP1 −/− mice. GSSG export by MRP1 leads to a perturbation of endothelial redox state and ultimately endothelial cell apoptosis. Endothelial MRP1 may provide a novel therapeutic target for prevention of vascular disease.

BACKGROUND: Traditionally, a safety margin of at least 10 J between the maximum output of the pulse generator and the energy needed for ventricular defibrillation has been used because lower safety margins were associated with unacceptably high rates of failed defibrillation and sudden cardiac death. The Low Energy Safety Study (LESS) was a prospective, randomized assessment of the safety margin requirements for modern implantable cardioverter-defibrillator (ICD) systems. METHODS AND RESULTS: A total of 636 patients undergoing initial ICD implantation with a dual-coil lead and active pulse generator were evaluated. The defibrillation threshold (DFT) and enhanced DFT (DFT+ and DFT++) were measured using a modified step-down protocol. Conversion testing of induced ventricular fibrillation before discharge, at 3 months, and at 12 months was performed, as was randomization to chronic programming at either 2 steps above DFT++ or maximal output. The induced ventricular fibrillation data had conversion success rates of 91.4%, 97.9%, 99.1%, 99.6%, and 99.8% for safety margins of 0, 1, 2, 3, and 4 steps above the DFT++, respectively. A margin of 4 to 6 J was adequate to maintain high conversion success over time (98.9% before discharge versus 99.2% at 12 months; P=NS). Over a mean follow-up of 24+/-13 months, conversion of spontaneously occurring ventricular tachyarrhythmias >200 bpm was identical (97.3%), despite a safety margin difference of 5.2+/-1.1 J for the 2-step group versus 20.8+/-4.2 J for maximal output. CONCLUSIONS: With a rigorous implantation algorithm, a safety margin of about 5 J is adequate for safe implantation of modern ICD systems.

STUDY DESIGN: A prospectively maintained database-generated retrospective review and cross-sectional outcome analysis was performed at a single academic center. OBJECTIVES: To assess the improvement in ASIA motor score (AMS) and secondarily to assess generic health related quality of life (HRQoL) and functional status; correlating these with variables that may predict outcome. SUMMARY OF BACKGROUND DATA: Many variables are potential contributors to motor recovery, patient function, and outcome following cervical trauma. Studies often suffer from low power, short follow-up, heterogeneous cohorts, and use of outcome instruments that are neither valid nor psychometrically sound. METHODS: AMS were collected within 72 hours of the time of injury and again at follow-up by trained examiners. The SF-36 and FIM were administered to all patients at follow-up. RESULTS: AMS improved from a mean of 58.7 at injury to a mean of 92.3 at follow-up. Bowel and bladder continence was reported by 81% while independent ambulation was reported by 86%. Final AMS was positively correlated with the AMS at injury, formal education, and presence of spasticity at follow-up. Functional status (FIM) was positively correlated with higher AMS at injury, formal education, absence of comorbidities, absence of spasticity, and younger age. Generic HRQoL outcomes (SF-36) were improved in individuals with more formal education, fewer comorbidities, absence of spasticity, and anterior column fractures. CONCLUSIONS: Although the majority of patients improve to an AMS between 90 and 100, many have significant disability and are less functional than the general population. Significant predictive variables include the initial motor score, formal education, comorbidities, age at injury, and development of spasticity. An assessment of more than just the motor score is required to obtain an appreciation of the function and outcomes in this population.

To define the long-term abdominal consequences of the TRAM flap procedure, 150 consecutive patients were evaluated 5 to 7.5 years postoperatively. Of 137 surviving patients, 135 (98.5 percent) returned a questionnaire (68 single pedicle, 63 double rectus harvest, and 4 single pedicle with contralateral microvascular augmentation) and 132 (96.4 percent) were examined and tested. By questionnaire, 64 percent noted overall improvement of the abdomen, 72 percent noted improved abdominal appearance, and 20 percent noted improved posture. Decreased abdominal strength was noted by 46 percent, and decreased exercise ability was noted by 25 percent. These figures were higher after double rectus harvest (60 and 35 percent) than after single rectus harvest (35 and 16 percent) (p = 0.005 and p = 0.014, respectively). Activities of daily living were rarely (4.0 to 5.8 percent) affected. Three of the patients had uncomplicated pregnancies and deliveries (two vaginal, one cesarean section). Situp performance was worse comparing postoperative patients with unoperated controls (p < 0.0005) and comparing double rectus harvest with single rectus harvest patients (p < 0.0005). Comparing double rectus harvest patients with direct abdominal closure and those closed with mesh, there was a trend toward poorer situp performance in the mesh subgroup; however, this was not statistically significant. On examination, a classic post-TRAM hernia was not encountered in any patient, but three single-pedicle patients had asymptomatic diffuse bulges through the fascial harvest site, visible only on straining to do a situp. Eight patients (seven bilateral and one single pedicle) had varying degrees of abdominal laxity, but only one had operative correction of diffusely attenuated abdominal fascia following pregnancy and delivery. Examiners' ratings of aesthetic abdominal appearance were higher for postoperative patients than for unoperated controls (p = 0.05). The vast majority of patients considered the TRAM procedure worthwhile (93 percent) and continued to recommend it to others (96 percent).

OBJECTIVE: The purpose of this study was to evaluate the factors associated with the recurrence of leiomyomata after myomectomy. METHODS: One hundred forty-five consecutive cases of myomectomy by laparotomy were studied retrospectively. Leiomyoma recurrence, diagnosed by transvaginal ultrasonography, was evaluated by life-table analysis and log-rank tests according to clinical characteristics of patients. RESULTS: The 5-year cumulative rates for leiomyoma recurrence and subsequent major surgery were 62% and 9%, respectively. At 5 years, the cumulative probability of recurrence was significantly lower in patients with a single leiomyoma removed (11%), compared with patients with multiple leiomyomata (74%) (P = .011); it was also lower in patients with intraoperative uterine size 10 menstrual weeks or less (46%), compared with more than 10 menstrual weeks (82%) (P = .032). However, there was a strong association of uterine size with the number of leiomyomata removed (P = .009). Childbirth after myomectomy was associated with a lower recurrence rate; the 5-year cumulative probability of recurrence was 26% in patients with subsequent parity, compared with 76% in those without subsequent parity (P = .010). CONCLUSION: Solitary myomectomy and smaller intraoperative uterine size are associated with lower rates of leiomyoma recurrence after myomectomy; the significance of uterine size may be affected by its correlation with the number of leiomyomata removed. Subsequent parity is associated with a lower probability of recurrence, but the cause and effect relationship between these two variables is unclear. LEVEL OF EVIDENCE: II-3.