Transcatheter Aortic Valve Replacement is Associated with Comparable Clinical Outcomes to Open Aortic Valve Surgery but with a Reduced Length of In-Patient Hospital Stay: A Systematic Review and Meta-Analysis of Randomised Trials.

BACKGROUND: Aortic valve replacement is indicated in patients with severe symptomatic aortic stenosis (AS). Transcatheter aortic valve replacement (TAVR) has evolved as a potential strategy in a growing proportion of patients in preference to surgical aortic valve replacement (SAVR). This meta-analysis aims to assess the differential outcomes of TAVR and SAVR in patients enrolled in published randomised controlled trials (RCTs). METHODS: A systematic literature search of Cochrane Library, EMBASE, OVID, and PubMed MEDLINE was performed. Randomised controlled trials of patients with severe AS undergoing TAVR compared with SAVR were included. Clinical outcomes and procedural complications were assessed. RESULTS: Five RCTs with a total of 3,828 patients (1,928 TAVR and 1,900 SAVR) were analysed. There was no statistically significant difference in combined rates of all-cause mortality and stroke at 30-days for TAVR vs SAVR (6.3% vs 7.5%; OR 0.83; 95% CI: 0.64-1.08; P=0.17) or at 12 months (17.2% vs 19.2%; OR 0.87; 95% CI: 0.73-1.03; P=0.29). No statistically significant difference was seen for death or stroke separately at any time point although a numerical trend in favour of TAVR for both was recorded. Length of in-patient stay was significantly less with TAVR vs SAVR (9.6 +/- 7.7 days vs 12.2 +/- 8.8 days; OR -2.94; 95% CI: -4.64 to -1.24; P=0.0007). Major vascular complications were more frequent in patients undergoing TAVR vs SAVR (8.2% vs. 4.0%; OR 2.15; 95% CI: 1.62-2.86; P <0.00001) but major bleeding was more common among SAVR patients (20.5% vs 44.2%; OR 0.34; 95% CI: 0.22-0.52; P=<0.00001). CONCLUSIONS: Transcatheter aortic valve replacement and SAVR are associated with overall similar rates of death and stroke among patients in intermediate to high-risk cohorts but with reduced length of in-patient hospital stay.

In vitro and in vivo characterization of three different modes of pump operation when using a left ventricular assist device as a right ventricular assist device.

Dual rotary left ventricular assist devices (LVADs) have been used clinically to support patients with biventricular failure. However, due to the lower vascular resistance in the pulmonary circulation compared with its systemic counterpart, excessively high pulmonary flow rates are expected if the right ventricular assist device (RVAD) is operated at its design LVAD speed. Three possible approaches are available to match the LVAD to the pulmonary circulation: operating the RVAD at a lower speed than the LVAD (mode 1), operating both pumps at their design speeds (mode 2) while relying on the cardiovascular system to adapt, and operating both pumps at their design speeds while restricting the diameter of the RVAD outflow graft (mode 3). In this study, each mode was characterized using in vitro and in vivo models of biventricular heart failure supported with two VentrAssist LVADs. The effect of each mode on arterial and atrial pressures and flow rates for low, medium, and high vascular resistances and three different contractility levels were evaluated. The amount of speed/diameter adjustment required to accommodate elevated pulmonary vascular resistance (PVR) during support with mode 3 was then investigated. Mode 1 required relatively low systemic vascular resistance to achieve arterial pressures less than 100 mm Hg in vitro, resulting in flow rates greater than 6 L/min. Mode 2 resulted in left atrial pressures above 25 mm Hg, unless left heart contractility was near-normal. In vitro, mode 3 resulted in expected arterial pressures and flow rates with an RVAD outflow diameter of 6.5 mm. In contrast, all modes were achievable in vivo, primarily due to higher RVAD outflow graft resistance (more than 500 dyn·s/cm(5)), caused by longer cannula. Flow rates could be maintained during instances of elevated PVR by increasing the RVAD speed or expanding the outflow graft diameter using an externally applied variable graft occlusion device. In conclusion, suitable hemodynamics could be produced by either restricting or not restricting the right outflow graft diameter; however, the latter required an operation of the RVAD at lower than design speed. Adjustments in outflow restriction and/or RVAD speed are recommended to accommodate varying PVR.

Performance monitoring in cardiac surgery: application of statistical process control to a single-site database.

BACKGROUND: Graphical Statistical Process Control (SPC) tools have been shown to promptly identify significant variations in clinical outcomes in a range of health care settings. We explored the application of these techniques to quantitatively inform the routine cardiac surgical (CAS) morbidity and mortality (M&M) review processes at a single site. METHODS: Baseline clinical and procedural data relating to 5265 consecutive cardiac surgical procedures, performed at St Andrew's War Memorial Hospital (SAWMH) between the 1st January 2003 and the 30th April 2012, were retrospectively evaluated. A range of appropriate clinical outcome indicators (COIs) were developed and evaluated using a combination of Cumulative Sum charts, Exponentially Weighted Moving Average charts and Funnel Plots. Charts were updated regularly and discussed at the cardiac surgery unit's bi-monthly M&M meetings. Risk adjustment (RA) for the COIs was developed and validated for incorporation into the charts to improve monitoring performance. RESULTS: Discrete and aggregated measures, including blood product/reoperation, major acute post-procedural complications, cardiopulmonary bypass duration and Length of Stay/Readmission < 28 days have proved to be valuable measures for monitoring outcomes. Instances of variation in performance identified using the charts were examined thoroughly and could be related to changes in clinical practice (e.g. antifibrinolytic use) as well as differences in individual operator performance (in some instances, driven by case mix). CONCLUSIONS: SPC tools can promptly detect meaningful changes in clinical outcome thereby allowing early intervention to address altered performance. Careful interpretation of charts for group and individual operators has proven helpful in detecting and differentiating systemic versus individual variation.

Use of graphical statistical process control tools to monitor and improve outcomes in cardiac surgery.

BACKGROUND: Graphical Statistical Process Control (SPC) tools have been shown to promptly identify significant variations in clinical outcomes in a range of health care settings. We explored the application of these techniques to qualitatively inform the routine cardiac surgical morbidity and mortality (M&M) review process at a single site. METHODS: Baseline clinical and procedural data relating to 4774 consecutive cardiac surgical procedures, performed between the 1st January 2003 and the 30th April 2011, were retrospectively evaluated. A range of appropriate performance measures and benchmarks were developed and evaluated using a combination of CUmulative SUM (CUSUM) charts, Exponentially Weighted Moving Average (EWMA) charts and Funnel Plots. Charts have been discussed at the unit's routine M&M meetings. Risk adjustment (RA) based on EuroSCORE has been incorporated into the charts to improve performance. RESULTS: Discrete and aggregated measures, including Blood Product/Reoperation, major acute post-procedural complications and Length of Stay/Readmission<28 days have proved to be usable measures for monitoring outcomes. Monitoring trends in minor morbidities provides a valuable warning of impending changes in significant events. Instances of variation in performance have been examined and could be related to differences in individual operator performance via individual operator curves. CONCLUSION: SPC tools facilitate near "real-time" performance monitoring allowing early detection and intervention in altered performance. Careful interpretation of charts for group and individual operators has proven helpful in detecting and differentiating systemic vs. individual variation.

Perforated mitral valve annular phlegmon with ventriculo-atrial fistula.

Herein we describe a case of perforated mitral valve annular abscess/phlegmon that presented as a new pan-systolic murmur in the setting of hallux osteomyelitis requiring amputation. We discuss the investigations, imaging and complex management challenges arising from this rare condition and the importance of considering a diagnosis of infective endocarditis in patients with a new cardiac murmur.

Modified root reconstruction methods to treat unruptured aneurysm of sinus of valsalva (UASOV)--two case reports.

Abstract : Aneurysms of the Sinus of Valsalva (ASOV) are rare. We describe two cases of huge unruptured ASOV and discuss the management options. The first case was treated with sinus reconstruction and the second case was treated with "Hemiroot Replacement". One year follow up was uneventful. Although unruptured, hemodynamically significant ASOV should be treated surgically to avoid long term complications.

Two-stage management of sternal wound infection using bilateral pectoralis major advancement flap.

OBJECTIVE: To report our experience using two staged bilateral pectoralis major flap as the sole treatment modality for sternal wound infection. METHODS: A retrospective study of 9417 open-heart surgery cases performed between 1998 and 2003 at The Prince Charles Hospital. Sixty-eight patients were referred to the plastic surgical team for consideration of bilateral pectoralis major flap as the sole treatment modality for sternal wound infection. RESULTS: There was a trend for early referral for flap operation (median 10 days) (p=0.49). The median postoperative ventilation time and ICU stay were 1 and 2 days, respectively. The median hospital stay after flap operation was 15.5 days. One-year overall survival was 91%. Ninety-five per cent healed stable sternum was achieved with 100% failure in patients with chronically unstable sternum. Early referral appears to be an important factor in preventing osteomyelitis formation (p=0.05) with the longest recurrence at 10 months postoperatively. CONCLUSIONS: The key to the successful management of deep sternal wound infection is early referral for pectoralis major flap operation. Our approach is safe with good long-term outcomes. We recommend this approach in all severe deep sternal wound infection but not in patients with chronic unstable sternum.

CryoLife-O'Brien stentless valve: 10-year results of 402 implants.

BACKGROUND: This truly stentless porcine valve is composite, without Dacron, and implanted supra-annularly. Ten-year analysis with magnetic resonance imaging is presented. METHODS: From 1992 to 2002, 402 patients (mean 73.5 years) had aortic valve replacement. Associated procedures were required in 252 patients (63%). Serial echoes provided 1340 studies. Clinical follow-up was 100%. Magnetic resonance imaging focused on aortic annulus extensibility. RESULTS: The 30-day mortality was 0.99% (4 deaths). Morbidity comprised thromboembolism (40 patients including 18 patients with permanent strokes); endocarditis (9 patients); and reoperation (9 patients [periprosthetic leak, 2; endocarditis, 5; technical needle damage, 1; and structural degeneration, 1]). Of 402 valves more than 10 years, five valves were explanted, one only for structural failure. Except for endocarditis (2 patients), no late deaths (69 patients, 1.5 months to 5.7 years) were valve related. Echocardiography demonstrated low gradients with good orifice areas, excellent ventricular regression (p = 0.0001 preoperative and postoperative comparisons) and late incompetence (mild in 45 patients and moderate in 9 patients). No living patient has severe incompetence. Magnetic resonance imaging demonstrated the annulus 'expanding and relaxing' throughout the cardiac cycle, the mean increase in cross-sectional area being 37%, resembling normal aortic root dynamics. CONCLUSIONS: Elderly patients received this hemodynamically acceptable valve with its simple, supra-annular implantation and satisfactory mid-term morbid-free lifestyle to 10 years maximum follow-up. With only one structural failure, restoration of valve annular extensibility may have a favorable influence on long-term durability.