Sclerotherapy with 3% polidocanol foam to treat second-degree haemorrhoidal disease: Three-year follow-up of a multicentre, single arm, IDEAL phase 2b trial.

BACKGROUND: Sclerotherapy with 3% polidocanol foam is becoming increasingly popular for the treatment of symptomatic I-II or III degree haemorrhoidal disease (HD). However, there are no studies that have reported a follow-up of more than 1 year. The purpose of this study was to analyse the long-term outcomes of sclerotherapy with 3% polidocanol foam in the treatment of II-degree HD. METHODS: This was an open label, single-arm, phase 2b trial conducted in 10 tertiary referral centres for HD. A total of 183 patients with II-degree HD, aged between 18 and 75 years with symptomatic HD according to the Goligher classification and unresponsive to medical treatment, were included in the study and underwent sclerotherapy with 3% polidocanol foam. The efficacy was evaluated in terms of bleeding score, haemorrhoidal disease symptom score (HDSS) and short health scale for HD (SHS-HD) score. Successful treatment was defined as the complete absence of bleeding episodes after 7 days (T1) according to the bleeding score. RESULTS: The overall success rate ranged from 95.6% (175/183) at 1 year to 90.2% (165/183) after the final 3 year follow-up. The recurrence rate, based on the primary outcome, ranged from 12% (15/125) to 28% (35/125). The greatest increase in recurrence (15) was recorded between 12 and 18 months of follow-up, then another five between 18 and 24 months. Both the HDSS and the SHS score remained statistically significant (p < 0.001) from a median preoperative value of 11 (10-13) and 18 (15-20) to 0 (0-2) and 4 (0-4), respectively. Symptom-free (HDSS = 0) patients, excluding patients converted to surgery, increased from 55.5% (101/182) at 1 year to 65.1% at 3 years (110/169). There were no intraoperative complications in redo-sclerotherapy nor additional adverse events (AEs) compared to the first 12 months. CONCLUSIONS: Sclerotherapy with 3% polidocanol foam is gradually establishing itself in the treatment of bleeding HD due to its repeatability, safety, convenience in terms of direct and indirect costs with the absence of discomfort for the patient as well as AEs rather than an excellent overall success rate.

Endoscopic Pilonidal Sinus Treatment: A Tertiary Care Academic Center Experience.

Background: Pilonidal disease (PD) represents one of the most common proctological diseases in young adults. Although several approaches to treating PD have been described, there is still a lack of agreement on which is the best. The aim of this study was to evaluate the long-term efficacy of endoscopic pilonidal sinus treatment (EPSiT) at a tertiary care academic center. Methods: Between June 2017 and January 2021, a total of 32 patients [12 women (37.5%) and 20 men (62.5%)] with a mean age of 29.22 ± 12.98 years were treated with EPSiT. Pre- and post-operative symptoms were assessed with a score of 0-5. Success was defined as the absence of any subjective symptoms, as well as by complete post-operative wound healing. Results: Most of the patients had a midline external opening (17/32; 53.1%), with a mean number of external openings of 2.41 (1-4) ± 1.04. The median post-operative pain score was 0, and the mean follow-up period was 22 (4-42) ± 11.49 months. The time to wound healing was reduced in patients with one opening (28.14 ± 4.06 days) compared to patients with two or more openings (33.64 ± 7.3 days) (p = 0.067). The mean operative time was longer in patients who subsequently had a recurrence (41.75 ± 6.24 vs. 34.18 ± 6.24 min; p = 0.031). The overall success rate was 87.5% (28/32), and the mean time to recurrence was 3.25 (2-5) ± 1.26 months. Conclusions: EPSiT represents a viable option for the treatment of PD. More evidence and a longer follow-up period are needed to validate the results.

Anatomo-functional outcomes of the laparoscopic Frykman-Goldberg procedure for rectal prolapse in a tertiary referral centre.

Rectal prolapse is a common disorder that represents a burden for patients due to the associated symptoms that may include both incontinence and constipation. Currently, a huge variation in techniques exist. The aim of this study was to evaluate the anatomo-functional results of the laparoscopic Frykman-Goldberg procedure (LFGP) for the treatment of both internal (IRP) and complete rectal prolapse (CRP). Between July 2004 and October 2019, 45 patients with IRP and CRP underwent a LFGP. The Cleveland Clinic Constipation Score (CCCS), Obstructed Defecation Syndrome Score (ODSS) and Vaizey Score (VS) were assessed preoperatively, 3 months before the procedure, 12 months after the procedures and at the final follow-up visit. The patients' mean age was 51.4 ± 17.9 (15-93) years, and the mean follow-up was 9.24 ± 4.57 (1.6-16.3) years. The VS, CCCS and ODSS significantly improved (p = 0.008; p < 0.001; p < 0.001) from median preoperative values of 3, 20 and 18 to 2, 6 and 5, respectively. Furthermore, the improvements in scores during follow-up remained constant and significant over time when considering the two groups separately (time effect for ODSS p < 0.001, for VS p = 0.026, for CCCS p < 0.001) and when the patients were divided by age (< 40, 41-60 and > 60; p < 0.001). The overall complication rate was 8.9% (4/45), and no intraoperative complications or anastomotic leakage occurred. Conversion to the open approach was not necessary in any case. The overall success rate was 97.7%, and only one recurrence in the IRP group occurred after 14 months. LRGP can be considered a safe, effective and long-lasting procedure in young patients with IRP or CRP, a history of ODS and a redundant sigmoid colon.

Short-Term Results of Sclerotherapy with 3% Polidocanol Foam for Symptomatic Second- and Third-Degree Hemorrhoidal Disease.

BACKGROUND: Hemorrhoidal disease (HD) is defined as the symptomatic enlargement and/or distal displacement of anal cushions and is one of the most common proctological diseases. Sclerotherapy (ST) with 3% polidocanol foam induces an inflammatory reaction with sclerosis of the submucosal tissue and consequent suspension of the hemorrhoidal tissue. The aim of this study was to evaluate the short-term effectiveness and safety of ST with 3% polidocanol foam for the treatment of symptomatic second- and third-degree HD. METHODS: A total of 66 patients with symptomatic second- and third-degree HD underwent a single ST session between March 2017 and July 2018. A visual analog scale score was used to assess post-operative pain and patient satisfaction. The symptoms severity and anal continence were investigated through the Hemorrhoid Severity Score (HSS) and Vaizey score, respectively, at baseline, at 4 weeks and after 1 year. RESULTS: Fifty-seven out of 66 patients were male (86.3%), and the mean age was 52 (29-75; SD ± 12) years. The mean operative time was 4.5 (2-6; SD ± 1.23) minutes. No intraoperative complications and no drug-related side effects occurred. The overall success rate was 78.8% (52/66 patients) after a single ST session and 86% after two ST sessions (57/66 patients). The mean treatment effect, obtained comparing preoperative and 12 months symptom scores in each patient, showed a median change of 8 (p < 0.001). All patients resumed their normal daily activities the day after the procedures. CONCLUSIONS: ST with 3% polidocanol foam is a safe, cost-effective and repeatable conservative treatment.

Use of an Aortic Valve Replacement Simulation Model to Understand Hospital Costs and Resource Utilization Associated With Rapid-deployment Valves.

PURPOSE: Aortic stenosis (AS) is the most common cause of adult valvular heart disease. In the past decade, minimally invasive surgery (MIS) to treat AS has gained popularity, especially if performed in combination with rapid deployment valves (RDVs), which shorten cross-clamp time (XCT). This study examines specific outcomes and related costs of aortic valve replacement (AVR) before and after the introduction of RDVs. METHODS: We used the AVR simulator, an economic model developed to correlate cost and resource utilization associated with the adoption of RDVs, to compare 2 scenarios: (1) a current scenario based on standard AVR practices and (2) a proposed scenario based on increasing use of RDVs and an MIS approach. Both scenarios involved 3 subgroups of patients treated with (1) conventional AVR, (2) MIS, and (3) AVR combined with a coronary artery bypass graft. The current scenario (status quo) involved patients treated with traditional biological valves, and the proposed scenario involved patients who underwent implantation with an RDV. The AVR simulator was fed with real-world input data to estimate complication rates and resource consumption in the proposed scenario. Real-world input data for this analysis were obtained from patients diagnosed with a symptomatic heart valve disease between 2015 and 2018, at Clinica-San-Gaudenzio, Novara, Italy. Lastly, the AVR simulator estimated hospital savings by comparing the 2 scenarios. FINDINGS: A total of 132 patients underwent implantation with a traditional biological valve, and 107 were treated with a commercial valve system. The RDV was associated with an increase of 52% of patients undergoing MIS, which generated a 6.1-h reduction of XCT and a total savings of €6695. RDVs also reduced intensive care unit (ICU) and hospital ward length of stay (LOS), leading to savings of €677 and €595 per patient, respectively. Mortality and blood transfusions also improved. The savings for the hospital (related to shorter XCT, hospital ward LOS, and ICU LOS) amounted to €144.111. Our findings were consistent with data gathered from our real-word setting, and results of a sensitivity analysis indicate that our findings were robust across different possible situations. IMPLICATIONS: Switching to RDVs and MIS procedures for AVRs was associated with a reduction of costs related to XCT, hospital ward LOS, and ICU LOS. Hospitals can upload literature- and experience-based clinical and cost values to the AVR simulator to estimate a hospital's performance with the introduction of RDVs compared with standard biological valves. This study was not randomized, so more extensive studies could confirm our results in the future.

Altemeier's procedure for complete rectal prolapse; outcome and function in 43 consecutive female patients.

BACKGROUND: The aim of this retrospective study was to evaluate morbidity, mortality, postoperative function and recurrences in patients treated by Altemeier's rectosigmoidectomy for complete rectal prolapse in a referral center for pelvic floor functional disorders. METHODS: Peri-operative data on 43 consecutive female patients were reviewed. At follow-up any change in pelvic floor function and recurrences were determined. Thirty four patients were assessed at a median interval of 49 (2-135) months, six being deceased for reason not related to the prolapse and three lost to follow-up. RESULTS: Post-operative complications at 30 days occurred in 18 patients (38%). Major complication occurred in only one patient that was pneumonia with lung failure. Major complications were not related to the ASA score, BMI or age [average age 76.4]. There was no post-operative mortality at 30 days. At long-term follow-up functional results demonstrate a statistically significant decrease in the Obstructive Defecation Syndrome (ODS) score, but no statistically significant changes in the Vaizey score, the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) score and the urinary retention score. ODS score decreased with respect to levatorplasty and the change was statistically significant instead of Vaizey score in which were not. At the same follow-up there were 12 (35%) cases of recurrence with an estimated risk at 48 months of 40%. There were no statistically significant differences between patients with and without recurrence regarding age (p = 0.188), BMI (p = 0.864), ASA score (p = 0.433), previously repaired prolapse (p = 0.398), previous hysterectomy (p = 0.705), length of resected bowel (p = 0.126), and levatorplasty (p = 0.304). Patient satisfaction showed a mean of 8.8 and 6.4 respectively in patients without and with recurrences (p = 0.012). CONCLUSIONS: Altemeier's procedure had in our series low complications rate and no mortality. It offered improved evacuation in constipated patients while didn't improve fecal and urinary continence. Recurrence of prolapse was 40% at four years.

The role of Geriatric screening tool (G8) in predicting side effect in older patients during therapy with aromatase inhibitor.

BACKGROUND: Endocrine therapy is the main treatment in hormonosensitive breast cancer; the most frequent side effects are arthralgia, osteoporosis, depression, dyslipidemia and hypertension. G8 is a simple test developed to identify older patients who could benefit from a comprehensive geriatric assessment (CGA). The aim of this study is to evaluate the possible role of G8 in predicting side effects from treatment with aromatase inhibitor in women ≥65 years old. MATHERIAL AND METHOD: Women ≥65 years old affected by breast cancer about to start a therapy with an aromatase inhibitor, in the adjuvant setting, were evaluated with the G8 tool. Patients were classified as "fit" with G8 score > 14 or "vulnerable" with G8 score ≤ 14; they then started treatment and clinical-instrumentalfollow-up. RESULTS: From April 2016 to February 2018, 50 consecutive patients were screened. Median age was 75.1 (range 65-86). G8 identified 30 patients (60%) as "fit" (score > 14) and 20 (40%) as "vulnerable" (score ≤ 14). The grade of concordance between G8 score and the appearance/absence of adverse events were statistically significant (41/50 patients, 82%, p = 0.0002); sensitivity resulted in 78% and specificity was 81%; positive predictive value was 70% and negative predictive value was 87%. The most frequent adverse event was arthromyalgia. CONCLUSION: The G8 screening tool has a potential role in predicting side effects during a treatment with aromatase inhibitor. G8 could be very useful in everyday clinical practice for this population.

Safe Reentry for False Aneurysm Operations in High-Risk Patients.

BACKGROUND: In the absence of a standardized safe surgical reentry strategy for high-risk patients with large or anterior postoperative aortic false aneurysm (PAFA), we aimed to describe an effective and safe approach for such patients. METHODS: We prospectively analyzed patients treated for PAFA between 2006 and 2015. According to the preoperative computed tomography scan examination, patients were divided into two groups according to the anatomy and extension of PAFA: in group A, high-risk PAFA (diameter ≥3 cm) developed in the anterior mediastinum; in group B, low-risk PAFA (diameter <3 cm) was situated posteriorly. For group A, a safe surgical strategy, including continuous cerebral, visceral, and coronary perfusion was adopted before resternotomy; group B patients underwent conventional surgery. RESULTS: We treated 27 patients (safe reentry, n = 13; standard approach, n = 14). Mean age was 60 years (range, 29 to 80); 17 patients were male. Mean interval between the first operation and the last procedure was 4.3 years. Overall 30-day mortality rate was 7.4% (1 patient in each group). No aorta-related mortality was observed at 1 and 5 years in either group. The Kaplan-Meier overall survival estimates at 1 and 5 years were, respectively, 92.3% ± 7.4% and 73.4% ± 13.4% in group A, and 92.9% ± 6.9% and 72.2% ± 13.9% in group B (log rank test, p = 0.830). Freedom from reoperation for recurrent aortic disease was 100% at 1 year and 88% at 5 years. CONCLUSIONS: The safe reentry technique with continuous cerebral, visceral, and coronary perfusion for high-risk patients resulted in early and midterm outcomes similar to those observed for low-risk patients undergoing conventional surgery.

Low-Dose Paclitaxel Reduces S100A4 Nuclear Import to Inhibit Invasion and Hematogenous Metastasis of Cholangiocarcinoma.

Nuclear expression of the calcium-binding protein S100A4 is a biomarker of increased invasiveness in cholangiocarcinoma, a primary liver cancer with scarce treatment opportunities and dismal prognosis. In this study, we provide evidence that targeting S100A4 nuclear import by low-dose paclitaxel, a microtubule-stabilizing agent, inhibits cholangiocarcinoma invasiveness and metastatic spread. Administration of low-dose paclitaxel to established (EGI-1) and primary (CCA-TV3) cholangiocarcinoma cell lines expressing nuclear S100A4 triggered a marked reduction in nuclear expression of S100A4 without modifying its cytoplasmic levels, an effect associated with a significant decrease in cell migration and invasiveness. While low-dose paclitaxel did not affect cellular proliferation, apoptosis, or cytoskeletal integrity, it significantly reduced SUMOylation of S100A4, a critical posttranslational modification that directs its trafficking to the nucleus. This effect of low-dose paclitaxel was reproduced by ginkolic acid, a specific SUMOylation inhibitor. Downregulation of nuclear S100A4 by low-dose paclitaxel was associated with a strong reduction in RhoA and Cdc42 GTPase activity, MT1-MMP expression, and MMP-9 secretion. In an SCID mouse xenograft model, low-dose metronomic paclitaxel treatment decreased lung dissemination of EGI-1 cells without significantly affecting their local tumor growth. In the tumor mass, nuclear S100A4 expression by cholangiocarcinoma cells was significantly reduced, whereas rates of proliferation and apoptosis were unchanged. Overall, our findings highlight nuclear S100A4 as a candidate therapeutic target in cholangiocarcinoma and establish a mechanistic rationale for the use of low-dose paclitaxel in blocking metastatic progression of cholangiocarcinoma. Cancer Res; 76(16); 4775-84. ©2016 AACR.

Human Cardiac Progenitor Spheroids Exhibit Enhanced Engraftment Potential.

A major obstacle to an effective myocardium stem cell therapy has always been the delivery and survival of implanted stem cells in the heart. Better engraftment can be achieved if cells are administered as cell aggregates, which maintain their extra-cellular matrix (ECM). We have generated spheroid aggregates in less than 24 h by seeding human cardiac progenitor cells (hCPCs) onto methylcellulose hydrogel-coated microwells. Cells within spheroids maintained the expression of stemness/mesenchymal and ECM markers, growth factors and their cognate receptors, cardiac commitment factors, and metalloproteases, as detected by immunofluorescence, q-RT-PCR and immunoarray, and expressed a higher, but regulated, telomerase activity. Compared to cells in monolayers, 3D spheroids secreted also bFGF and showed MMP2 activity. When spheroids were seeded on culture plates, the cells quickly migrated, displaying an increased wound healing ability with or without pharmacological modulation, and reached confluence at a higher rate than cells from conventional monolayers. When spheroids were injected in the heart wall of healthy mice, some cells migrated from the spheroids, engrafted, and remained detectable for at least 1 week after transplantation, while, when the same amount of cells was injected as suspension, no cells were detectable three days after injection. Cells from spheroids displayed the same engraftment capability when they were injected in cardiotoxin-injured myocardium. Our study shows that spherical in vivo ready-to-implant scaffold-less aggregates of hCPCs able to engraft also in the hostile environment of an injured myocardium can be produced with an economic, easy and fast protocol.

Activity of a three-drug combination including cisplatin (CLOVER regimen) for poorly differentiated neuroendocrine carcinoma.

BACKGROUND/AIM: No standard treatment has been established for poorly-differentiated neuroendocrine carcinomas (PDNEC). The aim of this study is to evaluate the response to the combination of three drugs. MATERIAL AND METHODS: We reviewed 21 PDNEC patients treated from 2008 to 2013 in two Institutions. Five patients were initially treated with epirubicin, fluorouracil and temozolomide. Because of toxicity, the regimen was modified into cisplatin, capecitabine and dacarbazine (scheme B-CLOVER regimen). RESULTS: Primary tumor site was: pancreas 7 (33%), lung 5 (24%), colon-rectum 5 (24%), unknown 3 (14%) and stomach 1 (5%). The response rate was 24% (0 complete response, 24% partial responses, 38% stable disease, 9% progression and 19% unassessable). The global overall survival (OS) is 13 months (range=1-29) and progression-free survival (PFS) was 6 months (range=1-11). CONCLUSION: The combination chemotherapy of cisplatinum, capecitabine and dacarbazine is feasible and should be considered as an option for PDNEC.

The effect of sacral nerve modulation on cerebral evoked potential latency in fecal incontinence and constipation.

OBJECTIVE: Influence of sacral nerve modulation (SNM) on cerebral somatosensory evoked potentials (SEP) was determined in patients with incontinence and constipation. BACKGROUND: Selection of patients with incontinence and constipation for SNM could be improved. METHODS: The latency (ms) of SEP induced by pudendal nerve stimulation was compared before (T0) and at 1 month during peripheral nerve evaluation (PNE) of SNM at frequencies of 21 Hz (T1) and 40 Hz (T2). The results were correlated with clinical outcome at 6 months. RESULTS: In 16 of 23 incontinent patients with clinical "success" from SNM (Wexner incontinence score ≤7), there was a significant difference between P40 latency at T0 and T2 (38.81 vs. 37.49 ms, P = 0.049). In the 7 with "failure," there was no change between T0 and T2. In 12 of 19 constipated patients with "success" (Wexner constipation score ≤15), there was no difference between T0 and T2 P40 latency (39.28 vs. 38.25 ms, P = 0.374). In the 7 with "failure," there was a significant fall in P40 latency (41.20 vs. 39.30 ms, P = 0.047) but not to the normal range. The T0 P40 latency in incontinent patients having "success" was significantly higher than in the normal range (P = 0.044). In constipated patients it was significantly higher than in the normal range in both those with "success" (P = 0.001) and "failure" (P = 0.022). CONCLUSIONS: Measurement of P40 latency of SEP at baseline and at 1 month of SNM at a frequency of 40 Hz may help to predict the outcome of SNM and thus influence the decision for permanent implantation for patients with incontinence and constipation.

The brachio-brachial arteriovenous fistula: mid-term results.

OBJECTIVE: To evaluate the mid-term results of the brachio-brachial arteriovenous fistula in patients without adequate superficial venous circulation in the upper limb. METHODS: Retrospective analysis included 49 patients, in whom a brachio-brachial fistula had been created in an end-to-side configuration. After the maturation period (1 month), the brachial vein was transposed into the subcutaneous tissue. Follow-up study was performed in patients with functional brachio-brachial fistula after the superficialization. RESULTS: Forty-nine patients underwent 49 brachio-brachial fistula constructions. All fistulas were functional. One month after surgery, 40 (81.6%) of these patients had a functional fistula, but in only 39 (79.6%) cases was the fistula suitable for hemodialysis (HD) following transposition to subcutaneous tissue. During the 1-month maturation period, the fistula became occluded in nine patients, and in one case the vein was permeable, so the fistula was functional, but too small to permit HD. Seventeen patients developed temporary edema of the forearm during the first month, in three cases the edema was extended to the entire arm, but no other complications were associated with the procedure. Follow-up lasted 18.0 +/- 11.1 (3-37) months, during which 7/39 patients presented with fistula occlusion. Three patients died and another three were out of the study for various reasons. CONCLUSIONS: The brachio-brachial fistula is a good alternative to prosthetic grafts in patients without superficial venous circulation in the upper limb.

Preventing restenosis after implantation of bare stents with oral rapamycin: a randomized angiographic and intravascular ultrasound study with a 5-year clinical follow-up.

OBJECTIVES: To establish the efficacy of oral rapamycin at a dose of 2 mg for 1 month at reducing the 6-month restenosis rate after the implantation of bare metal stents. METHODS: A prospective, 1:1 randomized, single-blind, placebo-controlled study was conducted in 108 consecutive patients assigned immediately after stent implantation to oral rapamycin (4 mg loading dose followed by 2 mg daily for 30 days) or a placebo. RESULTS: Rapamycin was maintained in 98% of patients. Angiographic in-stent binary restenosis was 14.3% in the rapamycin group versus 32.1% in the placebo group, with a relative risk (RR) of 0.45 (95% CI 0.24-0.84, p = 0.015). The rapamycin blood concentration at 15 days correlated with binary restenosis (p = 0.044). The volume obstructions found by intravascular ultrasound for the rapamycin and the placebo groups were 18.1+/-10.7 and 27.1+/-15.7% (p = 0.002), respectively. Major adverse cardiac events at a 5-year follow-up were 31.5% for the rapamycin group and 50.0% for the placebo group (RR 0.63, 95% CI 0.39-1.01, p = 0.078). CONCLUSIONS: Oral rapamycin significantly reduces the incidence of restenosis at follow-up compared to a placebo.We believe these findings deserve further testing in larger trials.

Cardiac resynchronization therapy as an adjunct to conventional surgical treatment for heart failure.

From March 2004 through October 2007, we prospectively evaluated the benefits of cardiac resynchronization therapy as an adjunct to conventional procedures in patients who were undergoing surgery for heart failure.Twenty severely symptomatic patients (14 men and 6 women, with a mean age of 70 +/- 8 years) who displayed advanced cardiomyopathy, QRS duration > or =130 ms, or mechanical dyssynchrony, underwent isolated or combined coronary artery revascularization and mitral valve overreduction. In all patients, an epicardial lead was secured to the left ventricular wall at the end of the procedure and its extremity was brought into a subclavian pocket. In 5 patients, a resynchronization device was implanted at the time of surgery; in 8, it was implanted at a later date; the remaining 7 patients are awaiting implantation. One patient died postoperatively of low-output syndrome. There was 1 noncardiac late death. Eighteen patients were alive at a mean postoperative follow-up of 21.6 +/- 15.2 months (range, 1-43 mo). There were no subsequent hospital admissions after discharge. New York Heart Association functional class and left ventricular performance were significantly and lastingly improved when cardiac resynchronization therapy was added to the surgical procedure. Despite the limitations inherent in the small number of patients and the relatively short duration of follow-up, this study suggests that patients with dilated cardiomyopathy and left ventricular dyssynchrony in whom surgical correction is indicated may benefit from cardiac resynchronization therapy using a resynchronization device connected to an epicardial lead secured to the left ventricle at the time of surgery.

The efficacy and safety of extending the ischemic time with a modified cardioplegic technique for coronary artery surgery.

BACKGROUND AND AIM: The need to intermittently discontinue the administration of cardioplegia in order to complete the surgical procedure is a major drawback of antegrade warm blood cardioplegia. An ischemic time of 15 minutes is generally considered safe based on empirical observation. The aim of this study was the evaluation of the efficacy and safety of an intermittent warm blood cardioplegia with intervals between administrations prolonged to 25 minutes. METHODS: Ninety-seven patients undergoing primary elective coronary artery revascularization were prospectively randomized into two groups. The first, Intermittent Antegrade Warm Blood Cardioplegia (IAWBC) group, comprising 49 patients, received standard intermittent antegrade warm blood cardioplegia repeated every 15 minutes. The second, Modified Intermittent Antegrade Warm Blood Cardioplegia (M-IAWBC) group, comprising 48 patients, received intermittent antegrade warm blood cardioplegia supplemented with magnesium sulfate (MgSO(4)), delivered in volumes proportional to the ventricular mass and repeated every 25 minutes. The clinical outcomes were evaluated. The levels of creatine kinase-MB (CK-MB) isoenzyme, in addition to the echocardiographic assessment of septal dyskinesia and tricuspid annulus plane systolic excursion (TAPSE), have been used as markers of myocardial damage. RESULTS: There were no statistically significant differences in clinical outcomes, need for inotropes and vasodilators, length of stay in the intensive care unit, and postoperative levels of CK-MB between the two groups. Likewise, postoperative echocardiographic assessment showed no relevant differences. CONCLUSIONS: Administration of warm antegrade cardioplegic solution supplemented with MgSO(4), delivered in volumes proportional to ventricular mass every 25 minutes, provides adequate myocardial protection for coronary artery surgery.

High thoracic epidural anesthesia in cardiac surgery: risk factors for arterial hypotension.

There is an interest in the use of high thoracic epidural anesthesia in cardiac surgery, because experimental and clinical studies have suggested that central neuroaxial blockade attenuates the response to surgical stress and improves myocardial metabolism and perioperative analgesia-thus enabling earlier extubation and a smoother postoperative course. Matters of major concern in the adoption of high thoracic epidural anesthesia in cardiac surgery are neurologic injury secondary to neuroaxial hematoma and hypotension secondary to sympatholysis. The risk associated with possible neuraxial hematoma caused by high thoracic epidural anesthesia has been thoroughly investigated and largely discounted, but scant attention has been devoted to the onset of hypotensive episodes in the same setting. We analyzed the hypotensive episodes that occurred in a series of 144 patients who underwent on-pump cardiac surgery procedures. Among the patient variables that we tested in a multivariate logistic-regression model, only female sex was found to be significantly correlated with hypotension. In order to decrease the incidence and severity of hypotensive episodes resulting from anesthetic blockade, anesthesiologists need to monitor, with special care, women patients who are under high thoracic epidural anesthesia. Further studies are needed in order to determine why women undergoing open heart surgery under high thoracic epidural anesthesia are at a relatively greater risk of hypotension.