Early Clinical Outcomes In Patients Research Articles

Hepatic resection for hepatic metastases from gastric adenocarcinoma.

PurposeThe effects of hepatic resection on patients with metastatic tumors from gastric adenocarcinomas are unclear. Therefore, we analyzed early clinical outcomes in patients who underwent surgical resection for hepatic metastases from gastric adenocarcinomas.Materials and MethodsFrom January 2003 to December 2010, 1,508 patients with primary gastric cancers underwent curative gastric resections at the Korea Cancer Center Hospital. Of these patients, 12 with liver-only metastases underwent curative hepatic resection. Their clinical data were analyzed retrospectively.ResultsThe median follow-up period was 12.5 months (range, 1~85 months); no operative mortalities or major complications were observed. Three patients underwent synchronous resections, and 9 underwent metachronous resections. In the latter group, the median interval between gastrectomy and hepatectomy for hepatic metastasis was 10.5 months (range, 5~47 months). The overall 1- and 5-year survival rates of these 12 patients were 65% and 39%, respectively, with a median overall survival of 31.0 months; 2 patients survived for >5 years.ConclusionsHepatic resection can be a feasible procedure for treating hepatic metastases from gastric adenocarcinomas. Although this study was small and involved only selected cases, the outcomes of the hepatic resections were comparable and long-term (>5 years) survivors were identified. Surgical resection of the liver can be considered a feasible option in managing hepatic metastases from gastric adenocarcinomas.

Dose-normalization for exposure to mycophenolic acid and the early clinical outcome in patients taking tacrolimus after heart transplantation

The early phase of MPA exposure has rarely been investigated after solid organ transplantation, especially in heart transplantation patients. We evaluated the association between exposure to mycophenolic acid (MPA), a main metabolite of mycophenolate mofetil (MMF), and clinical events within 3 months after heart transplantation. Trough (C0) and area under the curve (AUC)0-12h levels of MPA and its metabolite, mycophenolic acid glucuronide (MPAG), were determined using high-performance liquid chromatography. Corresponding clinical endpoints included acute rejection or MMF-related adverse events (gastrointestinal symptoms, leucopenia, and anemia). AUC measurements (n=77) were collected from 21 patients. Dose-normalized C0 and AUC0-12h levels were used to evaluate the association between MPA or MPAG exposure and MMF-related adverse events. No acute rejection or mortality occurred during the follow-up period. Twelve patients (57%) developed 13 MMF-related adverse events. The MMF dose was tapered from 2.50 g/day on D1 to 1.55±0.54 g/day on D90. Significantly higher levels of dose-normalized MPA C0 and AUC0-12h were associated with the events than with the absence of the events (C0: 1.04±0.42 vs. 0.84±0.85 µg/mL/g [p=0.047]; AUC0-12h: 20.37±3.21 vs. 14.97±1.13 µg × h/mL/g; [p=0.038]). Conclusions Dose-normalized MPA exposure may protect against MMF toxicity in the early stage after heart transplantation. The MMF dose can be decreased to near 1.5 g/day 3 months post-transplantation without jeopardizing patient safety; a well-planned, tapered MMF regimen should also be considered.

Custom-fit minimally invasive total knee arthroplasty: effect on blood loss and early clinical outcomes

Recently, new custom-fit pin guides in total knee arthroplasty (TKA) have been introduced. Use of these guides may reduce operating time. Use of the guides combined with the absence of intramedullary alignment jigs may lead to reduced blood loss and improved early outcomes. Our aim was to evaluate blood loss and early clinical outcomes in patients undergoing minimally invasive TKA using custom-fit magnetic resonance imaging (MRI)-based pin guides. A prospective study in 80 patients was carried out. Patients were divided randomly into 2 equal groups. In one group, intramedullary alignment jigs were used. In the second group, custom-fit MRI-based pin guides were used. All patients received the same cemented posterior-stabilized implant through a mini-midvastus approach. The volume in the drain bottles was recorded after 48 h. Hb loss was estimated by subtracting the postoperative from the preoperative Hb level. Transfusion requirements and surgical time were recorded. Outcome measures were Knee Society Scores (KSS), knee flexion, knee swelling and pain. There was lower mean drainage of blood in the custom-fit group (391 ml vs. 603 ml; p < 0.0001). There was no difference in estimated loss of Hb (3.6 g/dl vs. 4.1 g/dl; n.s.) and in transfusion requirements (7.5 % vs. 10 %; n.s.). Surgical time was reduced in the custom-fit group (12 min less; p = 0.001). KSS measured at week 2, 6 and 12 showed no significant difference between groups. Knee flexion measured on days 7, 10 and at week 6, 12 and knee swelling and pain measured on days 1, 3, 10 and at week 6, 12 showed no significant difference between groups. Using custom-fit pin guides reduces blood drainage, but not the estimated Hb loss in minimally invasive TKA and does not affect transfusion rate. Surgical time is reduced. There is no effect on the early clinical outcomes. Therapeutic study, Level I.

Transplantation of initially rejected donor lungs after ex vivo lung perfusion

Ex vivo lung perfusion has the potential to increase the number of patients treated with lung transplantation. Our initial clinical experience with ex vivo lung perfusion is reviewed as well as early clinical outcome in patients transplanted with reconditioned lungs. Six pairs of donor lungs deemed unsuitable for transplantation underwent ex vivo lung perfusion with Steen solution mixed with red blood cells to a hematocrit of 10% to 15%. After reconditioning, lung function was evaluated and acceptable lungs were transplanted. Technical experience with ex vivo lung perfusion as well as clinical outcome for patients transplanted with ex vivo lung perfusion-treated lungs were evaluated. Donor lungs initially rejected either as a result of an inferior partial pressure of arterial oxygen/ fraction of inspired oxygen (n = 5; mean, 20.5 kPa; range, 9.1-29.9 kPa) or infiltrate on chest radiograph (n = 1) improved their oxygenation capacity to a mean partial pressure of arterial oxygen/fraction of inspired oxygen of 57 ± 10 kPa during the ex vivo lung perfusion (mean improvement, 33.6 kPa; range, 21-51 kPa; P < .01). During evaluation, hemodynamic (flow, vascular resistance, pressure) and respiratory (peak airway pressure, compliance) parameters were stable. Two single lungs were not used for lung transplantation because of subpleural hematoma or edema. Six recipients from the regular waiting list underwent single (n = 2) or double (n = 4) lung transplantation. One patient had primary graft dysfunction grade 2 at 72 hours. Median time to extubation was 7 hours. All patients survived 30 days and were discharged in good condition from the hospital. The use of ex vivo lung perfusion seems safe and indicates that some lungs otherwise refused for lung transplantation can be recovered and transplanted with acceptable short-term results.

Combined clopidogrel and aspirin treatment up to surgery increases the risk of postoperative myocardial infarction, blood loss and reoperation for bleeding in patients undergoing coronary artery bypass grafting†

Recent guidelines suggest that patients undergoing coronary artery bypass grafting (CABG) should discontinue clopidogrel and aspirin (ASA) 5 and 2-10 days, respectively, before surgery to reduce postoperative bleeding and its complications. The aim of our study was to evaluate the relationship between the timing of discontinuing clopidogrel + ASA and early clinical outcomes in patients undergoing CABG. Four thousand three hundred and thirty consecutive patients underwent isolated CABG from April 2004 to February 2009. Of these, 926 patients received double antiplatelet therapy in the 14 days prior to surgery. Patients were stratified into three groups: clopidogrel + ASA within 5 and 2 days, respectively, before surgery (Group A, n = 287); clopidogrel within 5 days + ASA stopped 2-10 days before surgery or clopidogrel stopped 5 days + ASA within 2 days of surgery (Group B, n = 308) and clopidogrel + ASA discontinued >5 and 10 days, respectively, before surgery (control group, n = 331). Overall mortality was 0.8%. The incidence of postoperative myocardial infarction (MI) was 5.2, 1 and 1.8% in Groups A, B and control, respectively (P = 0.004). Reoperation for bleeding occurred in 4.5, 2.9 and 1.2% (P = 0.04) and total chest drainage was 761 ± 473, 720 ± 421 and 687 ± 302 ml in Groups A, B and control, respectively (P = 0.06). Multivariable analysis revealed that Group A was an independent predictor of postoperative MI (P = 0.02), reoperation for bleeding (P = 0.02), blood transfusions (P = 0.003) and blood losses (P = 0.015). Clopidogrel in combination with ASA up to the time of surgery is associated with an increased risk of postoperative MI, blood loss and reoperation for bleeding in patients undergoing CABG.

Admission Leukocytosis Is Not Associated with Early Response to Tissue Plasminogen Activator in Patients with Acute Ischemic Stroke (P02.198)

Objective: We examined the relationships between admission leukocytosis and clinical response to intravenous tissue plasminogen activator (rt-PA) and early clinical outcomes in patients with acute ischemic stroke (AIS) receiving rt-PA. Background In patients with acute coronary events treated with IV rt-PA, the presence of leukocytosis is associated with impaired microvascular perfusion and increased re-occlusion rates. Within 24hr of an ischemic event, neutrophils and other acute-phase mediators invade the ischemic tissue releasing pro-inflammatory cytokines promoting endothelial damage. The degree of acute-phase response is related to infarct size and functional outcome. Design/Methods: We undertook a single-center retrospective analysis of patients treated with IV rt-PA for AIS between July 2008 and June 2010. Patients were excluded for in-hospital strokes, infections within 72hr of admission, and for corticosteroids taken in the month before admission or during hospitalization. Leukocyte counts were considered elevated if it exceeded our laboratory reference range for normal ( Results: Eighty-five patients met inclusion criteria; 20% had leukocytosis. Age, race, glucose, and NIHSS were similar, but patients with leukocytosis were more likely to be female (p=0.049). No difference in ΔNIHSS from admission to 24hr post-tPA was detected in patients with leukocytosis (or elevated neutrophils or lymphocytes) compared to those with normal WBC counts. Patients with leukocytosis had similar frequencies of sICH, neurological deterioration, and length of stay and similar median mRS scores. The ΔNIHSS from admission to discharge was significantly greater (p=0.0044) in patients with leukocytosis, but other outcomes were similar (sICH, neurological deterioration, length of stay, and mRS). Conclusions: At our center, patients with AIS and leukocytosis at the time of IV rt-PA had similar improvement in NIHSS when compared to those with normal WBC counts, arguing against a deleterious interaction. The improvement in NIHSS score by discharge and higher frequency of favorable discharge disposition requires validation and further exploration. Disclosure: Dr. Gillette has received research support from the Infectious Disease Society of America. Dr. Siegler has nothing to disclose. Dr. Kumar has nothing to disclose. Dr. Boehme has nothing to disclose. Dr. Martin-Schild has nothing to disclose. Dr. Albright has nothing to disclose.

Elevated Factor VIII Is Common in the Acute Phase of Ischemic Stroke and Is Associated with African American Race and Poor Outcomes (S43.007)

Objective: We sought to characterize the relationship between factor VIII, patient characteristics, stroke severity, etiology, and early clinical outcomes in patients with acute ischemic stroke. Background Factor VIII drives the formation of fibrin rich clot. Elevation of factor VIII has been associated with higher risk of large vessel arterial occlusions. The relationship of factor VIII with etiology and outcomes in the acute phase of ischemic stroke is poorly understood. Design/Methods: We reviewed factor VIII levels in patients with acute ischemic stroke treated at our stroke center between July 2008 and April 2011. Factor VIII levels were considered elevated if exceeding the laboratory reference range: normal 0-150%. Baseline demographics, laboratory data, clinical course and outcome were compared in patients with normal or elevated levels. Spearman9s correlations were used to assess associations between factor VIII levels and collected variables. Results: Factor VIII level was elevated in 62% of the 73 patients. Significant correlations were found between factor VIII levels and African American race (0.37, p=0.001), hematocrit (-0.340, p=0.003), and platelet count (0.241, p=0.04), treatment with IV tPA (r=-0.24, p=0.041), length of stay (r=.307, p=0.009), discharge NIHSS (r=.338, p=0.004), discharge mRS (r=0.388, p=0.001), and poor discharge disposition (r=0.245, p=0.037). No relationship was found between factor VIII and baseline stroke severity or etiology. After adjusting for IV tPA use, new stroke on MRI, and race, factor VIII was a significant independent predictor of higher discharge NIHSS (p=0.016), higher mRS (p=0.025), and poor disposition (p=0.045). Conclusions: High factor VIII level, found in the majority of patients with acute ischemic stroke, was associated with poor early outcomes. Additional studies are required to determine if factor VIII is causal or a marker of poor outcome in patients with acute ischemic stroke and whether factor VIII contributes to the increased risk of stroke in African American patients. Disclosure: Dr. Chang has nothing to disclose. Dr. Albright has nothing to disclose. Dr. Kruse-Jarres has nothing to disclose. Dr. Leissinger has nothing to disclose. Dr. Martin-Schild has nothing to disclose.

Minimally Invasive Approaches Versus Conventional Sternotomy for Aortic Valve Replacement: A Propensity Score Matching Study

BackgroundThe aim of this study is to evaluate our institutional results of the aortic valve replacement through minimally invasive approaches compared with conventional sternotomy.Materials and MethodsFrom August 1997 to July 2010, 838 patients underwent primary isolated aortic valve replacement. Of them, 73 patients underwent surgery through minimally invasive approaches (MIAS group) whereas 765 patients underwent surgery through the conventional sternotomy (CONV group). Clinical outcomes were compared using a propensity score matching design.ResultsPropensity score matching yielded 73 pairs of patients in which there were no significant differences in baseline profiles between the two groups. Patients in the MIAS group had longer aortic cross clamp than those in the CONV group (74.9±27.9 vs.. 66.2±27.3, p=0.058). In the MIAS group, conversion to full sternotomy was needed in 2 patients (2.7%). There were no significant differences in the rates of low cardiac output syndrome (4 vs. 8, p=0.37), reoperation due to bleeding (7 vs. 6, p=0.77), wound infection (2 vs. 4, p=0.68), or requirements for dialysis (2 vs. 1, p=0.55) between the two groups. Postoperative pain was significantly less in the MIAS group than the conventional group (pain score, 3.79±1.67 vs. 4.32±1.56; p=0.04).ConclusionBoth minimally invasive approaches and conventional sternotomy had comparable early clinical outcomes in patients undergoing primary isolated aortic valve replacement. Minimally invasive approaches significantly decrease postoperative pain.

Procedural and early clinical outcomes of patients with de novo coronary bifurcation lesions treated with the novel Nile PAX dedicated bifurcation polymer-free paclitaxel coated stents: results from the prospective, multicentre, non-randomised BIPAX clinical trial

To demonstrate the acute and early outcomes of the novel Nile PAX dedicated polymer-free paclitaxel-coated stents (Minvasys SAS, Gennevilliers, France) in the treatment of de novo coronary bifurcation lesions. The Nile PAX device incorporates a cobalt-chromium alloy with a side aperture in the mid-stent designed to optimise scaffold at the bifurcation carina and side branch (SB) ostium, while maintaining SB access during procedure. From December 2008 to February 2010, 101 patients were prospectively enrolled in a non-randomised, multicentre study. Lesion criteria were: vessel size 2.5-3.5 mm in the parent vessel (PV) and 2.0-3.0 mm in the SB, and lesion length <14 mm in the PV, and <5 mm in the SB. Mean age was 63 years, 29% had diabetes, LAD/Dg was involved in 80.4%, and 61.7% had significant involvement of both branches. The study stent was successfully attempted and implanted in 98%. SB received additional stent in 26% final kissing-balloon inflation was performed in 93% and lesion (angiographic) success was achieved in 98%. There was only one non-Q myocardial infarction during hospitalisation, and no additional events up to 30 days. Preliminary results of the prospective, non-randomised, multicentre BIPAX clinical trial demonstrated encouraging results with the novel Nile PAX bifurcation DES in the treatment of coronary bifurcation lesions, including high device and procedural success. Overall, there was only one major adverse cardiac event during hospitalisation, with no additional events up to 30 days follow-up. Long-term follow-up is warranted.

The role of helical tomotherapy in the treatment of bone plasmacytoma

We evaluated the early clinical outcome of patients with solitary bone plasmacytoma (SP) or a solitary lesion of multiple myeloma (MM) treated with helical tomotherapy (HT) compared with 3D conformal radiotherapy (3D-CRT), in terms of target coverage and exposure of critical organs. Ten patients with SP and 3 patients with a solitary lesion of MM underwent radiation therapy (RT) delivered by HT, to a dose of 40 Gy in 20 fractions. Treatment planning was then performed with 3D-CRT and the dosimetric parameters of both techniques were compared. Patients were also assessed for response to treatment and acute toxicities. With a median follow-up of 13 months, 78% of patients with pain before RT had resolution of their symptoms. Coverage of target lesion was adequate with both techniques in 12 of 13 patients. Target coverage was significantly lower for HT (V95% = 98.55% vs. 97.15%; p = 0.04, for 3D-CRT and HT, respectively). Target overdoses were also lower with HT (V105% = 2.01% vs. 0.19%; p= 0.16), although nonsignificant. Finally, there were no significant differences in organs-at-risk irradiation between both techniques. The early treatment tolerance was excellent, with no toxicity higher than grade I. RT of SP and MM with a solitary lesion can be safely delivered with HT, with no major acute side effects and good symptomatic control. Finally, HT provides a dosimetry similar to that of 3D-CRT in terms of organs-at-risk sparing and target volume coverage.

No clear influence of preference bias on satisfaction and early functional outcome in resurfacing hip arthroplasty

Background and purpose Hip resurfacing arthroplasty (RHA) is done in patients who often have a high preference for the method. This preference can influence the clinical outcome and satisfaction. We evaluated the potential influence of this preference bias.Patients and methods From an ongoing randomized trial comparing RHA with total hip arthroplasty, 28 consecutive patients (28 hips) who had been allocated to an RHA were characterized as the “randomized” group. 22 other patients (24 hips) who had refused participation and had especially requested an RHA were characterized as the “preference” group. Harris hip score (HHS), Oxford hip score (OHS), University of California at Los Angeles activity scale (UCLA), Short Form 12 (SF-12), and visual analog scale satisfaction score (VAS) were assessed in both groups.Results Both groups had a high implant satisfaction score (97/100 for the “preference” group and 93/100 for the “randomized” group) at 12 months. The HHS, OHS, and UCLA were similar at baseline and also revealed a similar improvement up to 12 months (p < 0.001). Regarding the SF-12, the “preference” group scored lower on the mental subscale preoperatively (p = 0.03), and there was a greater increase after 12 months (p = 0.03).Interpretation We could not show that there was any influence of preference on satisfaction with the implant and early clinical outcome in patients who underwent RHA. The difference in mental subscale scores between groups may still indicate a difference in psychological profile.

Thoracic Epidural Anesthesia Improves Early Outcomes in Patients Undergoing Off-pump Coronary Artery Bypass Surgery

The aim of this two-center, open, randomized, controlled trial was to evaluate the impact of thoracic epidural anesthesia on early clinical outcomes in patients undergoing off-pump coronary artery bypass surgery. Two hundred and twenty-six patients were randomized to either general anesthesia plus epidural (GAE) (n = 109) or general anesthesia only (GA) (n = 117). The primary outcome was length of postoperative hospital stay. Secondary outcomes were: arrhythmia, inotropic support, intubation time, perioperative myocardial infarction, neurologic events, intensive care stay, pain scores, and analgesia requirement. Baseline characteristics were similar in the two groups. One patient died in the GAE group. Median postoperative stay was significantly reduced in the GAE, compared with the GA, group (5 days, interquartile range [5-6] vs. 6 days, interquartile range [5-7], hazard ratio = 1.39, 95% CI [1.06-1.82]; P = 0.017). The incidence of arrhythmias and the median intubation time were both significantly lower in the GAE, compared with the GA, group (odds ratio = 0.41, 95% CI [0.22-0.78], P = 0.006 and hazard ratio = 1.73, 95% CI [1.31-2.27], P < 0.001, respectively). Patients in the GAE group were more likely to need vasoconstrictors intraoperatively than in the GA group (odds ratio = 2.50, 95% CI [1.22-5.12]; P = 0.012). The GAE, compared with GA, group reported significantly lower levels of impairment for all pain domains and reduced morphine usage (odds ratio = 0.07, 95% CI [0.03-0.17]; P < 0.001). In patients undergoing off-pump coronary artery bypass surgery, the addition of thoracic epidural to general anesthesia significantly reduces the incidence of postoperative arrhythmias and improves pain control and overall quality of recovery, allowing earlier extubation and hospital discharge.

Comparison of 2 point-of-care platelet function tests, VerifyNow Assay and Multiple Electrode Platelet Aggregometry, for predicting early clinical outcomes in patients undergoing percutaneous coronary intervention

Various platelet function tests are currently used to measure responsiveness to antiplatelet therapy. We sought to compare 2 point-of-care platelet function tests, VerifyNow Assay (Accumetrics, San Diego, CA) and Multiple Electrode Platelet Aggregometry (MEA) (Dynabyte, Munich, Germany), for predicting early clinical outcomes after percutaneous coronary intervention. Platelet reactivity in the arachidonic acid-induced and adenosine diphosphate (ADP)-induced platelet aggregation was measured simultaneously with the VerifyNow Assay and MEA in 222 patients undergoing percutaneous coronary intervention between August and October 2009. We investigated the correlations between the 2 tests and performed receiver operating characteristic curve analysis for major adverse cardiovascular events (MACE), a composite of death, myocardial infarction (MI), stroke, and target vessel revascularization, at 30 days. Major adverse cardiovascular events occurred in 19 patients (8.6%), including 14 patients with periprocedural MI and 5 patients with stroke. Correlations were weak between the 2 tests in the arachidonic acid-induced (Spearman r = 0.189, P = .006) and ADP-induced platelet reactivity (Spearman r = 0.390, P < .001). Although the VerifyNow P2Y12 Assay (Accumetrics) was able to predict periprocedural MI (area under the aggregation curve 0.680, P = .024) and 30-day MACE (area under the aggregation curve 0.649, P = .032), VerifyNow Aspirin Assay (Accumetrics), MEA ASPI test, and MEA ADP test failed to predict such clinical events. Hyporesponsiveness to clopidogrel based on the VerifyNow Assay was associated with about a 6-fold increased risk of MACE at 30 days. Hyporesponsiveness to clopidogrel measured by VerifyNow Assay was able to identify patients with dual antiplatelet therapy who were at higher risk for periprocedural MI and MACE at 30 days. Further randomized studies are required to validate the effectiveness of different platelet function tests for predicting long-term clinical outcomes.

Paper 5: The Effect of Platelet Enriched Plasma on Early Clinical Outcomes in Patients With Femoroacetabular Impingement Following Arthroscopic Labral Repair and Femoral Neck Osteoplasty

To compare the clinical outcome of patients treated with and without platelet-rich plasma (PRP) injection while undergoing arthroscopic labral repair and femoral neck osteoplasty for femoral acetabular impingement. Patients were randomized at the time of surgery to receive either an intra-articular injection of 5 cc of PRP, or an equal volume of 0.9% normal saline. All patients underwent arthroscopic labral repair and osteoplasty of the femoral neck and, at the conclusion of the case, received the injection. One week following surgery, thigh circumference (measured 10 cm distal to the tip of the greater trochanter) and the presence of ecchymosis of the thigh were recorded. Clinical outcome scores, including Non-Arthritic Hip Score, Modified Harris Hip Score and Hip Outcome Score were collected prior to surgery at 1, 3, 6 and a minimum of 12 months post-operatively. Thirty-five patients were enrolled into this study. Twenty patients received a PRP injection and 15 received a saline injection. Thigh circumference was compared pre-operatively and 1 week post-operatively. There was no significant difference between the two groups. Ecchymosis was compared between the two groups at 1 week post-operatively. Four of the 20 patients in the PRP group and 10 of the 15 in the placebo group demonstrated bruising on the lateral thigh. This was compared with a Chi-Square test and found to be statistically significant (P1⁄4 0.005). There was no significant difference in any of the outcome scores between the two groups. An intra-articular injection of PRP after labral repair did not improve the clinical outcome up to 1 year post-operatively in patients undergoing arthroscopic labral repair and osteoplasty of the femoral neck. Level of evidence is level I study.

Early clinical outcomes of floating platform mobile-bearing TKA: longitudinal comparison with fixed-bearing TKA

This study was conducted to longitudinally compare a new floating platform mobile-bearing (MB) prosthesis with an established fixed-bearing (FB) system with respect to early clinical outcomes in patients with bilateral TKAs using the MB prosthesis in one knee and the FB prosthesis in the other. Clinical outcomes (ROM, AKS and WOMAC scores, and side preference), evaluated at 6, 12 and 24 months postoperatively, were compared between knees fitted with the MB prosthesis (e.motion-FP) or the FB prosthesis (Genesis II) in 66 patients who underwent bilateral TKA. In addition, the same comparisons between the knees fitted with the MB prosthesis and the knees with the FB prosthesis were made separately in the subgroup of 33 patients implanted with a cruciate retaining FB (FB-CR) prosthesis and the other subgroup of 33 patients with a posteriorly stabilized FB (FB-PS) prosthesis in a knee. The floating platform MB prosthesis achieved comparable clinical outcomes to the FB prosthesis. No significant differences were found between the FB- and MB-implanted sides at any time with respect to the outcome scales, and temporal patterns were similar. However, comparisons of FB-CR and FB-PS patient groups revealed different temporal patterns. In the FB-CR group, most outcome scales were improved at 6 months, peaked at 12 months and then remained at this level at 24 months. In contrast, outcomes in the FB-PS group improved much faster to almost peak at 6 months, and then remained at this level. In the FB-CR group, more patients preferred the knee with fitted with a MB prosthesis at 6 months. In contrast, in the FB-PS group, no side preference for the MB prosthesis was observed, and more patients preferred knees implanted with the FB prosthesis at 12 and 24 months. This study demonstrates that this new mobile-bearing prosthesis, designed as a floating platform, provides satisfactory clinical performances that are comparable to those achieved using the established fixed-bearing prosthesis in terms of clinical outcomes.

Duration of Symptoms Is Not Always the Key Modulator of the Choice of Reperfusion for ST-Elevation Myocardial Infarction

Fibrinolytic therapy (FT) and primary percutaneous coronary intervention (PCI) are both well-accepted reperfusion therapies in ST-segment elevation myocardial infarction (STEMI). The evidence of randomized clinical trials indicates a relatively modest difference in 30-day mortality (≈1%) in favor of primary PCI over fibrin-specific FT and was based on very timely primary PCI (ie, a primary PCI–related delay of 40 minutes [door-to-balloon less door-to-needle time]).1 Longer delays to primary PCI, which are far more frequent in clinical practice,2 are associated with attenuated benefit or no benefit at all, particularly when compared with fibrin-specific FT.3,4 The benefit of timely primary PCI over FT is likely to especially apply to higher-risk patients.5,6 Irrespective of the method of reperfusion, the potential for myocardial salvage and better clinical outcome is inversely proportional to ischemic time or its only available clinical surrogate, symptom duration.7–12 These considerations underpin the notion expressed in the American College of Cardiology/American Heart Association (ACC/AHA) guidelines on the treatment of STEMI that timely reperfusion therapy is likely more important in determining outcome than whether FT or primary PCI is the chosen reperfusion method.13 Response by Armstrong et al p 1310 The ACC/AHA STEMI guidelines highlight the time point of 3 hours of symptom duration in guiding the choice of reperfusion therapy. They state that if symptom duration is <3 hours, no preference exists between FT and primary PCI provided that treatment is timely (for FT, door-to-needle time <30 minutes; for primary PCI, door-to-balloon time <90 minutes and ≤60 minutes between estimated needle time and estimated balloon time). However, if symptom duration exceeds 3 hours, these guidelines favor primary PCI over FT, again provided that primary PCI can be performed in a timely fashion.13 This article reexamines the evidence that may or may not be the basis …

Abstract 4039: Continuous Positive Airway Pressure From Out-of-hospital Setting To Cardiac Intensive Care Unit In Acute Heart Failure: A Multicenter Randomized Study

Purpose : Recent guidelines for acute heart failure (AHF) support the use of continuous positive airway pressure (CPAP) although its early use upstream intensive care unit (ICU) requires more evidence. The aim of this multicenter randomized study was to compare the effects of standard treatment of cardiogenic acute pulmonary oedema to CPAP when started in out-hospital setting and continued in ICU. Methods : AHF presenters with respiratory distress were enrolled by 10 emergency medical mobile services. Inclusion criteria were respiratory rate &gt;25, pulse oxygen saturation &lt;90% in air and Killip score ≥3. Each eligible patient was randomly assigned at home to receive standard treatment (ST) including oxygen, nitroglycerin, diuretic and inotropic drug as appropriate, or a combination of ST and CPAP (7.5–10 cmH 2 O). The primary end point, a composite of death, presence of intubation criteria or persistence at the second hour after inclusion, reappearance of the inclusion criteria or circulatory failure, was assessed within the first 48 hours after inclusion. The analysis was done by intention to treat. Results : 207 patients (80 ± 10 years, 59% females) were enrolled. Baseline characteristics and standard treatment were balanced between the 2 groups. The mean duration of CPAP was 1 hour prior to admission and 2 hours after admission. The primary end-point was observed in 36% of patients in ST and 21.5% in ST+CPAP (p=0.028). There was no difference in the rate of death (5% vs. 3.75% for ST and ST+CPAP, respectively), although the use of CPAP was associated with a significant reduction of persistent respiratory distress (26% vs 12%, p&lt;0.01), of haemodynamic failure (6% vs 1%, p 0.05) and in the rate of intubation criteria (14% vs 4%, p=0.01). Clinical benefits of CPAP were found irrespective of left ventricular dysfunction and of normo/hypercapnia measured at inclusion. Conclusion : the use of CPAP upstream ICU and continued after admission improves improves early clinical outcome of patients presenting with cardiogenic acute pulmonary oedema.

Early Clinical Outcome in Patients Treated for Anal Canal Cancer using Dose-painted Intensity Modulated Radiation Therapy

Early Clinical Outcome in Patients Treated for Anal Canal Cancer using Dose-painted Intensity Modulated Radiation Therapy

Implantable Cardioverter-Defibrillator Lead Performance

Implantable cardioverter-defibrillators (ICDs) have revolutionized the treatment of patients at risk for sudden cardiac death. In the nearly 3 decades since the first human ICD implant,1 millions of devices have been implanted worldwide and innumerable lives have been saved. Successful resuscitation of a potentially lethal ventricular arrhythmia by an ICD system depends on successful arrhythmia detection and timely delivery of therapy. Both the ICD generator and the ICD lead are critical components of this system. The lead, in particular, is literally a lifeline whose purpose is to convey critical information about the heart’s rhythm to the ICD generator and, in turn, to deliver life-sustaining therapy when needed. Failure of an ICD lead may result in significant clinical events, including failure to pace, failure to defibrillate, inappropriate shocks, and even death. Article p 2727 ICD leads, like many medical technologies, have undergone a remarkable transformation. Epicardial leads, which necessitated a thoracotomy for lead placement, have given way to transvenous leads, which are easier to implant, less costly, and associated with decreased morbidity and mortality.2 Important advances in transvenous lead technology, such as the development of steroid elution, smaller diameter leads, novel insulations, and multipolar leads, have translated into meaningful clinical benefits for patients. Although modern ICD leads consist primarily of electrodes, conductors, insulation, and a fixation mechanism to attach the lead to the myocardium, lead design and performance vary from model to model. Indeed, monitoring of performance is critical not only to identify products with increased failure rates but also to provide physicians and patients with realistic expectations of device performance. In the current issue of Circulation , Eckstein et al add to our understanding of ICD lead performance.3 The investigators conducted a retrospective analysis of 1317 consecutive patients who received ICD systems (including 38 different ICD lead …

Resultados imediatos da artéria torácica interna direita e artéria radial como segundo enxerto arterial em revascularização do miocárdio

We sought to compare early clinical outcomes in patients receiving a right internal thoracic artery or a radial artery as the second arterial graft in myocardial revascularization. We retrospectively studied 58 consecutive patients who underwent coronary artery bypass surgery and received both a left internal thoracic artery graft and either a right internal thoracic artery (n=20) or a radial artery graft (n=38), between January 2004 and March 2006. Hospital mortality, pleural drainage, operative time and postoperative complications were analyzed. There were no significant preoperative differences between groups. There was only one (1.7%) in-hospital death which occurred in the Radial Group. Operative times was significantly higher in the Right Internal Thoracic Group (p-value = 0.0018), but were not associated with increased Intensive Care Unit stays, mechanical ventilation or other postoperative complications. We were able to perform significantly more distal anastomosis using the radial artery than the right internal thoracic artery (1.57 versus 1.05: p-value =0.003). In our group of patients, the use of a right internal thoracic artery as a second arterial graft was associated with a prolonged operative time, but had no interference with the immediate clinical outcomes.