Time to achieving therapeutic international normalized ratio increases hospital length of stay after heart valve replacement surgery.

BACKGROUND: Achieving a therapeutic international normalized ratio (INR) before hospital discharge is an important inpatient goal for patients undergoing mechanical cardiac valve replacement (MCVR). The use of clinical algorithms has reduced the time to achieve therapeutic INR (TTI) with warfarin therapy. Whether TTI prolongs length of stay (LOS) is unknown. METHODS: Patients who underwent MCVR over a consecutive 42-month period were included. Clinical data were obtained from the Society of Thoracic Surgeons Adult Cardiac Surgery database and electronic medical records. Therapeutic INR was defined as per standard guidelines. Warfarin dose was prescribed using an inpatient pharmacy-managed algorithm and computer-based dosing tool. International normalized ratio trajectory, procedural needs, and drug interactions were included in warfarin dose determination. RESULTS: There were 708 patients who underwent MCVR, of which 159 were excluded for reasons that would preclude or interrupt warfarin use. Among the remainder of 549 patients, the average LOS was 6.4days and mean TTI was 3.5days. Landmark analysis showed that subjects in hospital on day 4 (n=542) who achieved therapeutic INR were more likely to be discharged by day 6 compared with those who did not achieve therapeutic INR (75% vs 59%, P<.001). Multivariable proportional hazards regression with TTI as a time-dependent effect showed a strong association with discharge (P=.0096, hazard ratio1.3) after adjustment for other significant clinical covariates. CONCLUSIONS: Time to achieve therapeutic INR is an independent predictor of LOS in patients requiring anticoagulation with warfarin after MCVR surgery. Alternative dosing and anticoagulation strategies will need to be adopted to reduce LOS in these patients.

Impact of Reference Mismatch on Procedure Outcomes of Percutaneous Coronary Intervention.

A significant mismatch between proximal and distal reference lumen diameters of the target lesion may pose challenges during percutaneous coronary intervention (PCI) and therefore influence the outcomes. We investigated total 1706 lesions underwent IVUS guided percutaneous coronary intervention, that were divided into 2 groups, including 411 lesions in Mismatch group and 1295 lesions in Non-Mismatch group. After propensity score matching, 397 lesions in each group were selected for final data set. The analysis showed that Mismatch group PCI required more frequently use of post-stenting optimization (79.6% vs 53.9%, P < .001) using higher max pressure (19.5 ± 3.9 vs 16.7 ± 3.7 atm, P < .001). Besides, Mismatch group also encountered more PCI major complications (7.8% vs 4.0%, P = .024) and lower procedure success rate (91.4% vs 95.5%, P = .022). On final angiogram, Mismatch group had smaller minimum lumen diameter (2.62 ± .45 vs 2.90 ± .57 mm, P < .001) and lower angiographic success rate (93.2% vs 96.7%, P = .023). On final IVUS, Mismatch group had higher rate of incomplete stent apposition and stent edge dissection (6.3% vs 3.0%, P = .029 and 2.5% vs .5%, P = .021, respectively). In conclusion, reference mismatch posed significant challenging during PCI that led to unfavorable procedural outcomes. These impacts may translate into long-term clinical implications that need to be addressed in future studies.

The effects of barrier materials on reduction of pericardial adhesion formation in rabbits: a comparative study of a hyaluronan-based solution and a temperature sensitive poloxamer solution/gel material.

OBJECTIVE: This study was performed to examine the efficacy and safety of a hyaluronan solution (Guardix-SL) and a temperature sensitive poloxamer solution/gel material (Guardix-SG) on the prevention of pericardial adhesion in rabbits. METHODS: A total of 60 rabbits were divided into three groups according to material applied after epicardial abrasion: the control group (group CO), the Guardix SL group (group SL), and the Guardix SG group (group SG). The ejection fraction and the presence of pericardial effusion were evaluated by echocardiograms at the immediate postoperative period and 2 wk after the surgery. The adhesion was evaluated macroscopically and microscopically 2 wk after the surgery. RESULTS: In the group SG, mild pericardial effusions were observed only at the immediate postoperative period in 10 out of 20 rabbits with an insignificant reduction of the ejection fraction. Group CO had a significantly higher macroscopic adhesion and fibrosis score than did groups SL and SG (P < 0.001), and group SL had a significantly higher adhesion score than did group SG (P = 0.045). Inflammation score and the expression of anti-macrophage antibody in group CO were higher than those in groups SL and SG, although the differences were not significant. CONCLUSIONS: Guardix-SL and Guardix-SG effectively reduced the adhesion formation, and Guardix-SG is more effective than Guardix-SL for preventing adhesion. However, Guardix-SG showed a potential disadvantage of decreasing the ejection fraction, although this was statistically insignificant. Further study to verify the appropriate dosage to maximize the therapeutic effect without decreasing the heart function is needed.

Intraperitoneal and intravenous lidocaine for effective pain relief after laparoscopic appendectomy: a prospective, randomized, double-blind, placebo-controlled study.

BACKGROUND: The preemptive intravenous and intraperitoneal application of local anesthetics is known to improve the postoperative outcome in abdominal surgery. The aim of this study was to compare the analgesic effect of intravenous lidocaine injection to that of intraperitoneal lidocaine instillation in patients who were undergoing laparoscopic appendectomy (LA). METHOD: Sixty-eight patients who were undergoing LA for unperforated appendicitis were randomly divided into three groups. Group IP (the intraperitoneal instillation group) received intraperitoneal instillation of lidocaine and intravenous normal saline injection. Group IV (the intravenous injection group) received intravenous lidocaine injection and intraperitoneal instillation of normal saline. In group C (the placebo control group), normal saline was given both intravenously and intraperitoneally. The visual analog scale (VAS) of pain scores was measured after surgery. The needs for additional intravenous fentanyl were evaluated and the integrated fentanyl consumption (PCA delivered + additional fentanyl) was assessed. The incidence of shoulder tip pain and postoperative nausea and vomiting (PONV) were noted. RESULTS: Reduction of the VAS score and of fentanyl consumption was noted in the IV and IP groups and compared to that of group C (P < 0.05). The shoulder tip pain and PONV were reduced in groups IP and IV compared to that in group C (P < 0.05). However, no significant differences were found between the IP and IV groups for all the studied variables. There was no adverse effect from intravenous lidocaine throughout the study. CONCLUSION: Intravenous lidocaine injection is as effective as intraperitoneal instillation for reducing pain and fentanyl consumption. The major benefit of intravenous injection is that this is an easily and universally applicable procedure compared to that of intraperitoneal instillation. Lidocaine intravenous administration is a better alternative for reducing the pain of patients who are undergoing laparoscopic surgery.

A Multicenter, Randomized, Controlled Trial for Assessing the Usefulness of Suppressing Thyroid Stimulating Hormone Target Levels after Thyroid Lobectomy in Low to Intermediate Risk Thyroid Cancer Patients (MASTER): A Study Protocol.

BACKGROUND: Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer to prevent the recurrence of thyroid cancer. With the recent increase in small thyroid cancer cases, the extent of resection during surgery has generally decreased. Therefore, questions have been raised about the efficacy and long-term side effects of TSH suppression therapy in patients who have undergone a lobectomy. METHODS: This is a multicenter, prospective, randomized, controlled clinical trial in which 2,986 patients with papillary thyroid cancer are randomized into a high-TSH group (intervention) and a low-TSH group (control) after having undergone a lobectomy. The principle of treatment includes a TSH-lowering regimen aimed at TSH levels between 0.3 and 1.99 µIU/mL in the low-TSH group. The high-TSH group targets TSH levels between 2.0 and 7.99 µIU/mL. The dose of levothyroxine will be adjusted at each visit to maintain the target TSH level. The primary outcome is recurrence-free survival, as assessed by neck ultrasound every 6 to 12 months. Secondary endpoints include disease-free survival, overall survival, success rate in reaching the TSH target range, the proportion of patients with major cardiovascular diseases or bone metabolic disease, the quality of life, and medical costs. The follow-up period is 5 years. CONCLUSION: The results of this trial will contribute to establishing the optimal indication for TSH suppression therapy in low-risk papillary thyroid cancer patients by evaluating the benefit and harm of lowering TSH levels in terms of recurrence, metabolic complications, costs, and quality of life.

Management of the mitral valve in patients with obstructive hypertrophic cardiomyopathy.

Septal myectomy is the gold standard treatment option for patients with obstructive hypertrophic cardiomyopathy whose symptoms do not respond to medical therapy. This operation reliably relieves left ventricular outflow tract gradients, systolic anterior motion of the mitral valve, and associated mitral valve regurgitation. However, there remains controversy regarding the necessity of mitral valve intervention at the time of septal myectomy. While some clinicians advocate for concomitant mitral valve procedures, others strongly believe that the mitral valve should only be operated on if there is intrinsic mitral valve disease. At Mayo Clinic, we have performed septal myectomy on more than 3000 patients with obstructive hypertrophic cardiomyopathy, and in our experience, mitral valve operation is rarely necessary for patients who do not have intrinsic mitral valve disease such as leaflet prolapse or severe calcific stenosis. In this paper, we review anatomical considerations, imaging, and surgical approaches in the management of the mitral valve in hypertrophic cardiomyopathy.

Mitral Regurgitation in Patients With Hypertrophic Obstructive Cardiomyopathy: Implications for Concomitant Valve Procedures.

BACKGROUND: Incidence and outcome of mitral valve (MV) surgery are unknown in patients with hypertrophic obstructive cardiomyopathy (HOCM) undergoing extended transaortic septal myectomy. OBJECTIVES: This study sought to define indications and suitable operative strategy for mitral regurgitation (MR) in patients with HOCM. METHODS: A total of 2,107 septal myectomy operations performed in adults from January 1993 to May 2014 at Mayo Clinic in Rochester, Minnesota, were retrospectively reviewed. Patients with prior MV operation and apical hypertrophic cardiomyopathy were excluded. Overall, 2,004 operations were performed in 1,993 patients. RESULTS: Pre-operative MR was grade ≥3 (of 4) in 1,152 operations (57.5%). Systolic anterior motion of mitral leaflets caused the MR in most patients. However, intrinsic MV disease was identified pre-operatively in 99 patients, all of whom had MV surgery (with septal myectomy). In 1,905 operations, no intrinsic MV disease was identified pre-operatively; in 1,830 (96.1%), septal myectomy was performed without a direct MV procedure. For 75 patients, intrinsic MV disease discovered intraoperatively led to concomitant MV repair (86.7%) or replacement (13.3%). After isolated septal myectomy, the percentage of patients with MR grade ≥3 decreased from 54.3% to 1.7% (p = 0.001) on early post-operative echocardiography. Among 174 patients with concomitant MV surgery, late survival was superior with MV repair (n = 133 [76.4%]) versus replacement (10-year survival: 80.0% vs. 55.2%; p = 0.002). CONCLUSIONS: In most patients with HOCM, MR related to systolic anterior motion of the MV is relieved through adequate myectomy. Concomitant MV surgery is rarely necessary unless intrinsic MV disease is present. When MV procedures are required, repair is preferred because of improved survival compared with replacement.

Postoperative respiratory complications and peak airway pressure during laparoscopic colectomy in patients with colorectal cancer.

To determine whether the incidence of postoperative pulmonary complications increases in patients with high peak airway pressure (≥30 cm H2O) during laparoscopic colectomy, we investigated consecutive patients with colorectal cancer who had undergone laparoscopic colectomy. Of the 115 enrolled patients, 34 patients (30%) had peak airway pressure ≥30 cm H2O (an overload group). Compared with a nonoverload group (peak airway pressure <30 cm H2O), the overload group had a 5-fold greater incidence of postoperative respiratory complications and operations of longer duration, longer postanesthesia care unit stays, greater alveolar-arterial O2 differences, greater alveolar dead space-to-tidal volume ratios, and lower PaO2 measurements. Body mass index and preoperative alveolar-arterial O2 difference significantly affect higher peak airway pressure occurring during laparoscopic colectomy. Patients who had peak airway pressures ≥30 cm H2O during laparoscopic colectomy for colorectal cancer had higher incidence of postoperative respiratory complications than those whose peak airway pressures remained <30 cm H2O.

Frequency and evolution of thin-capped fibroatheromas in left main coronary artery as assessed by serial virtual histology intravascular ultrasound analysis.

BACKGROUND: The objective of the current study was to assess thin-capped fibroatheroma (TCFA) of the left main coronary artery (LMCA) and its changes after statin therapy. METHODS: We assessed the frequency and distribution of virtual histology intravascular ultrasound (VH-IVUS) thin-capped fibroatheroma (VH-TCFA) in the LMCA in 500 patients. Serial VH-IVUS examinations were available in 50 patients at 12-month follow-up. RESULTS: The incidence of LM-TCFA was 8.8% (44/500). IVUS LMCA length was longer in patients with VH-TCFA vs without VH-TCFA. Reference external elastic membrane (EEM) area was similar, but reference lumen area and minimal lumen area were smaller in LMCA with VH-TCFA vs without VH-TCFA (P<.001). LMCA with VH-TCFA had a higher plaque burden (P<.001), a larger necrotic core area (P<.001), and more dense calcium (P<.001) at the maximum necrotic core (NC) site vs LMCA without VH-TCFA. In patients with an LMCA length greater than the median, 62% were located in the distal half of the LMCA. After 12 months of statin therapy, only 44.4% (4/9) of VH-TCFA had evolved to a non- VH-TCFA phenotype and 3 new VH-TCFA had appeared. CONCLUSION: VH-TCFAs are clustered in the distal half of the LMCA with infrequent positive remodeling. It might persist despite the usual dose of statin therapy. Further study should confirm the changes in large vessels like the LMCA.

DICOM-based intravascular ultrasound signal intensity analysis: an Echoplaque Medical Imaging Bench study.

BACKGROUND: Most intravascular ultrasound (IVUS) data are stored digitally using the Digital Imaging and Communications in Medicine (DICOM) standard. This allows random access to studies and improves on the major limitation of conventional grayscale IVUS. METHODS: We harvested 129 coronary arteries from 43 autopsied cases. Grayscale IVUS and virtual histology-IVUS imaging were performed beginning 30 mm distal to the ostium of each coronary artery. Grayscale IVUS was processed; and the signal intensity was determined from DICOM-stored images using a new Medical Imaging Bench system (Echoplaque-MIB). We compared 436 regions of interest. The accuracy rate was expressed using the interpolation method and 95% confidence interval (CI). RESULTS: Patients' mean age was 49±9 years and 82% were men. Four patients succumbed to sudden cardiac death and 39 to noncardiac death. Grayscale IVUS signal intensity of dense calcium was 215±21.1 (95% CI: 207-223), that of fibrotic plaque was 75±17.8 (95% CI: 72-79), and that of fibrofatty plaque was 55±11.3 (95% CI: 52-59); however, the signal intensity of the necrotic core was between fibrotic plaque and dense calcium of 161±27.4 (95% CI: 153-168). Using the interpolation method, the cutoff values were as follows: fibrofatty plaque 0-65, fibrotic plaque 66-105, necrotic core 106-187, and dense calcium of at least 188. Overall, MIB grayscale had a 78.1% sensitivity and a 91.9% specificity versus histopathology. CONCLUSION: Plaque characterization using DICOM-based grayscale IVUS signal intensity analysis may improve on the major limitation of conventional grayscale IVUS: its inability to assess plaque composition.

Pre- and intraoperative lidocaine injection for preemptive analgesics in laparoscopic gastrectomy: a prospective, randomized, double-blind, placebo-controlled study.

BACKGROUND: The preemptive intravenous injection of local anesthetics is known to improve postoperative pains in abdominal surgery. The aim of this study is to assess the effect of intravenous lidocaine injection and analyze the precise amount of pain by computerized patient-controlled analgesia (PCA) in patients who had undergone laparoscopy-assisted distal gastrectomy (LADG). PATIENTS AND METHODS: A double-blind placebo control study was designed, and 34 patients undergoing LADG for early gastric cancer were divided into two groups. Preoperatively and throughout the surgery, Group I received intravenous lidocaine injection, and Group C received normal saline injection for placebo. Postoperative outcomes, including the visual analog scale (VAS), the button hit counts (BHC) from PCA, and amount of fentanyl consumed, were measured. RESULTS: The demographic data were similar between the groups. The VAS score, BHC, and fentanyl consumption were lower in Group I compared with Group C (P<.05). In particular, fentanyl consumption and BHC in Group I showed a significant decrease during the first 12 hours of the study (P<.05). Postoperative adverse events showed no difference except that nausea was more frequent in the placebo group (P=.039). CONCLUSIONS: In this study, intravenous lidocaine injection showed a significant reduction in fentanyl consumption and pain during the earlier postoperative time with more favorable outcomes.

The impact of mitral annular calcification on left ventricular function in nonagenarians.

BACKGROUND AND OBJECTIVES: Mitral annular calcification (MAC) is known to be associated with degenerative processes of the cardiac fibrous skeleton and cardiovascular disease mortality. However, MAC has not been evaluated in an extreme age group (patients >/=90 years of age). In this study, the clinical significance of MAC associated with aging was examined in this age group and compared with MAC associated with aging in a younger (20 to 50 years of age) group of patients. SUBJECTS AND METHODS: We assessed echocardiographic parameters in 43 nonagenarians and 51 young patients. In the nonagenarian group, patient's age was 92+/-2 years and 27% were male; in the young control group, patient's age was 36+/-9 years and 51% were male. Comprehensive M-mode and Doppler echocardiography, including tissue Doppler imaging, were performed. The frequency and severity of MAC was assessed from the leading anterior to the trailing posterior edge at its largest width for least 3 cardiac cycles. RESULTS: Echocardiography showed that the left ventricular (LV) end-diastolic dimension was larger in the young controls (p=0.007); however, the ejection fraction (EF) was lower in the nonagenarian group (p=0.001). The frequency of MAC was greater in nonagenarians {42/43 (97%)} than in controls {9/51 (17%), p<0.0001}. The maximal width of MAC was larger in nonagenarians (0.52+/-0.17 mm and 0.05+/-0.13 mm, p<0.0001). MAC was correlated with LV mass index (g/m(2)) (r=0.280, p=0.014) and EF (%) (r=-0.340, p=0.001). More importantly, early mitral inflow velocity/early diastolic mitral annulus velocity (E/E') was strongly correlated with MAC in non-agenarians (r= 0.683, p<0.0001). CONCLUSION: MAC may be associated with extreme age and increased LV filling pressure in nonagenarians. Further study is necessary to assess the cardiovascular mortality and structural changes related to mitral annulus calcification associated with aging.

Geometric reconstruction of the sinus of Valsalva: utilization of the porcine aortic root.

Surgical repair of ruptured sinus of Valsalva aneurysm can be challenging, although it has been reported that mortality and morbidity is low. Distortion of sinus of Valsalva geometry can cause aortic valve regurgitation immediately or progressively after surgery. Maintenance of the appropriate geometry of sinus of Valsalva after resection of the aneurysm is critical in preserving the native aortic valve and its competency. Successful reconstruction with various patch materials such as Dacron patches (DuPont, Wilmington, DE) or pericardial patches has been reported. Nevertheless, the size and shape of patches used had to be created impromptu by surgeons without reliable methodology of reproducing the precise shape of the naturally occurring sinus of Valsalva. Herein, we report a successful repair of sinus of Valsalva aneurysm by utilizing a porcine sinus of Valsalva from a commercially available Freestyle valve (Medtronic Inc, Minneapolis, MN). We believe that this is a previously unreported technique.