Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study).

Transcatheter aortic valve implantation (TAVI) has become the standard of care for many patients with symptomatic severe aortic stenosis who are at increased risk of morbidity and mortality during surgical aortic valve replacement. However, there is still no general consensus regarding the use of general anesthesia (GA) versus local anesthesia with sedation (non-GA) during the TAVI procedure. Using propensity score-matching analysis, we analyzed the characteristics and outcomes of patients who underwent TAVI with either GA (n = 245) or non-GA (n = 245) in the fully monitored, international, CoreValve ADVANCE Study. No statistically significant differences existed between the non-GA and GA groups in all-cause mortality (25.4% vs 23.9%, p = 0.78), cardiovascular mortality (16.4% vs 16.6%, p = 0.92), or stroke (5.2% vs 6.9%, p = 0.57) through 2-year follow-up. Major vascular complications were more common in the non-GA group. Total hospital stay was similar between the 2 groups. Conversion from non-GA to GA occurred in 13 patients (5.3%) because of procedural complications in 9 patients and discomfort or restlessness in 4 patients. Most procedural complications were related to valve positioning or vascular issues. Two of the 13 converted patients died during the procedure. Both GA and non-GA are widely used in real-world TAVI practice, and the decision appears to be guided by only a few patient-related factors and dominated by local and national practice. The outcomes of both anesthesia modes are equally good. When conversion from non-GA did occur, the complication requiring GA affected outcomes.

Transcatheter aortic valve implantation in patients with pre-existing chronic kidney disease.

BACKGROUND: We investigated the effect of chronic kidney disease (CKD) on morbidity and mortality following transcatheter aortic valve implantation (TAVI) including patients on haemodialysis, often excluded from randomised trials. METHODS AND RESULTS: We performed a retrospective post hoc analysis of all patients undergoing TAVI at our centre between 2008 and 2012. 118 consecutive patients underwent TAVI; 63 were considered as having (CKD) and 55 not having (No-CKD) significant pre-existing CKD, (defined as estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2). Chronic haemodialysis patients (n = 4) were excluded from acute kidney injury (AKI) analysis. Following TAVI, in CKD and No-CKD patients respectively, AKI occurred in 23.7% and 14.5% (p = 0.455) and renal replacement therapy (RRT) was necessary in 8.5% and 3.6% (relative risk (RR) [95% CI] = 2.33 [0.47-11.5], p = 0.440); 30-day mortality rates were 6.3% and 1.8% (p = 0.370); and 1-year mortality rates were 17.5% and 18.2% (p = 0.919). Patients who developed AKI had a significantly increased risk of 30-day (12.5% vs. 1.1%, p = 0.029) mortality. We found the presence of diabetes (odds ratio (OR) [95% CI] = 4.58 [1.58-13.3], p = 0.005) and elevated baseline serum creatinine (OR [95% CI] = 1.02 [1.00-1.03], p = 0.026) to independently predict AKI to statistical significance by multivariate analysis. CONCLUSION: TAVI is a safe, acceptable treatment for patients with pre-existing CKD, however caution must be exercised, particularly in patients with pre-existing diabetes mellitus and elevated pre-operative serum creatinine levels as this confers a greater risk of AKI development, which is associated with increased short-term post-operative mortality.

Patent foramen ovale closure prior to surgery in the sitting position.

Previously, patent foramen ovale (PFO) was an absolute contraindication to surgery in the sitting position. We report two patients with PFO who underwent surgery in the sitting position after percutaneous PFO closure. To our knowledge this is the first report of this technique.

Native aortic valve regurgitation: transcatheter therapeutic options.

Transcatheter aortic valve implantation (TAVI) is an acceptable treatment for patients with aortic stenosis but remains contraindicated for patients with native aortic valve regurgitation (NAVR). It is well established that patients with severe NAVR and symptoms have a poor prognosis if left untreated and that they should be offered surgical aortic valve replacement. There are patients with NAVR and at high surgical risk for whom conventional surgical aortic valve replacement may be unsuitable. Until recently there has been limited experience in the treatment of these patients with TAVI but outcomes from isolated case reports and small registries are encouraging. Of interest are certain new TAVI devices with design features which may make them better suited to the treatment of NAVR patients.

First-in-man assessment of a dedicated guidewire for transcatheter aortic valve implantation.

AIMS: The aim of this study was to evaluate the safety and performance of a specifically designed, dedicated TAVI guidewire. METHODS AND RESULTS: From May 2011 to August 2012, 39 consecutive patients referred for TAVI were prospectively enrolled in a first-in-man, open label, non-randomised feasibility study to evaluate the safety and performance of a specifically designed, dedicated TAVI guidewire in our institution (mean age 80.4±5.1 years, mean logistic EuroSCORE 26.8±11.7%, n=29 CoreValve transfemoral, n=8 CoreValve direct aortic, n=1 Edwards SAPIEN valve direct aortic, n=1 CoreValve subclavian). The primary safety endpoint was reached successfully with the dedicated TAVI guidewire in all 39 cases with no cases of guidewire displacement from the left ventricle during the procedure. In three cases the wire was repositioned to optimise loop position using a pigtail catheter prior to valve implantation. There were no cases of guidewire-related procedural complications. The mean delivery system tracking time using the guidewire was 1.4±0.6 minutes and the mean deployment time for TAVI was 13.8±7.8 minutes. CONCLUSIONS: This represents the first recorded use of a dedicated TAVI guidewire to treat patients with a transcatheter aortic valve. The wire is easy to place, safe to adjust within the ventricle, and the stiffness of the wire facilitates valve tracking through tortuous anatomy. In this study there were no pericardial complications with the use of this dedicated TAVI guidewire.

Complications at the time of transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) improves the prognosis of patients with severe aortic stenosis who are deemed too high risk for surgical valve replacement. However, this evolving technology is associated with a wide range of potential complications--some specific to TAVI, some often fatal. Prevention, early recognition, and effective treatment of these complications will significantly improve the outcome of this procedure and are essential prerequisites before the therapy is extended to lower-risk patient subsets.

Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry.

OBJECTIVES: The objective was to define the characteristics of a real-world patient population treated with transcatheter aortic valve implantation (TAVI), regardless of technology or access route, and to evaluate their clinical outcome over the mid to long term. BACKGROUND: Although a substantial body of data exists in relation to early clinical outcomes after TAVI, there are few data on outcomes beyond 1 year in any notable number of patients. METHODS: The U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry was established to report outcomes of all TAVI procedures performed within the United Kingdom. Data were collected prospectively on 870 patients undergoing 877 TAVI procedures up until December 31, 2009. Mortality tracking was achieved in 100% of patients with mortality status reported as of December 2010. RESULTS: Survival at 30 days was 92.9%, and it was 78.6% and 73.7% at 1 year and 2 years, respectively. There was a marked attrition in survival between 30 days and 1 year. In a univariate model, survival was significantly adversely affected by renal dysfunction, the presence of coronary artery disease, and a nontransfemoral approach; whereas left ventricular function (ejection fraction <30%), the presence of moderate/severe aortic regurgitation, and chronic obstructive pulmonary disease remained the only independent predictors of mortality in the multivariate model. CONCLUSIONS: Midterm to long-term survival after TAVI was encouraging in this high-risk patient population, although a substantial proportion of patients died within the first year.

The diagnostic and prognostic value of tissue Doppler imaging during dobutamine stress echocardiography in end-stage renal disease.

OBJECTIVE: To determine whether a quantitative measurement of peak systolic velocity (PSV) during dobutamine stress echocardiography (DSE) detects severe coronary artery disease (CAD) and predicts mortality in patients with end-stage renal disease. METHODS: One hundred and forty renal transplant candidates had DSE and coronary angiography. DSE analysis was performed using conventional visual wall motion assessment, longitudinal PSV, and combining the two modalities. Failure of PSV to rise by more than 50% predicted an ischemic response. Significant CAD was defined as luminal stenosis greater than 70%. RESULTS: The number of positive DSE studies according to conventional, PSV, and combined criteria was 41 (30%), 42 (31%), and 46 (34%) respectively. Forty patients (29%) had significant CAD at angiography. The sensitivity, specificity, positive and negative predictive values for conventional DSE analysis were 84, 91, 86, and 90% respectively. The same values for PSV analysis were 86, 92, 86, and 91%, respectively. The same values for the combination of visual and PSV analysis were 88, 94, 87, and 92% respectively. The differences between the three methods were not statistically significant. Sensitivity for single-vessel CAD (P=0.05) and circumflex artery disease (P=0.05) diagnosis was higher with PSV compared with conventional DSE analysis. Failure of PSV to rise by more than 50% during DSE was associated with significantly increased mortality (P=0.001). CONCLUSION: A quantitative interpretation of DSE, based on the percentage rise of PSV during stress, accurately detects CAD and predicts prognosis in end-stage renal disease.

The detection of myocardial ischemia in end-stage renal disease.

The outcome of acute coronary syndromes is usually poor in patients with end-stage renal disease (ESRD), and the early detection of myocardial ischemia is therefore essential in this group. However, the diagnosis of ischemina is often problematic in patients with ESRD, as cardiac symptoms and electrocardiography are not reliable predictors in this context. Silent ischemia is common and resting ECG is often abnormal in patients with ESRD. Therefore, alternatives to these predictors have been sought, and this review explores the role of myocardial perfusion imaging, dobutamine stress echocardiography and biochemical markers for use in the diagnosis of ischemia and risk stratification in patients with ESRD.

Evaluation of ischaemia-modified albumin as a marker of myocardial ischaemia in end-stage renal disease.

The early diagnosis of myocardial ischaemia is problematic in patients with ESRD (end-stage renal disease). The aim of the present study was to determine whether IMA (ischaemia-modified albumin) increases during dobutamine stress and detects myocardial ischaemia in patients with ESRD. A total of 114 renal transplant candidates were studied prospectively, and all received DSE (dobutamine stress echocardiography). IMA levels were taken at baseline and 1 h after cessation of DSE. A total of 35 patients (31%) had a positive DSE result. Baseline IMA levels were not significantly different in the DSE-positive and -negative groups. The increase in IMA was significantly higher in the DSE-positive group compared with those with no ischaemic response (26.5 +/- 19.1 compared with 8.2 +/- 9.6 kU/l respectively; P = 0.007; where kU is kilo-units). From ROC (receiver operator charactertistic) curve analysis, the optimal IMA increase to predict an ischaemic response was 20 kU/l, with a sensitivity of 81% and a specificity of 72% [area under the curve, 0.80 (95% confidence interval, 0.44-0.94); P = 0.03]. There were 18 deaths, ten of which were cardiac in nature over a follow up period of 2.25 +/- 0.71 years. An increase in IMA > or = 20 kU/l was associated with significantly worse survival (P = 0.02). In conclusion, IMA is a moderately accurate marker of myocardial ischaemia in ESRD. Patients with an increase in IMA > or = 20 kU/l during DSE had significantly worse survival.

Mitral annular calcification predicts mortality and coronary artery disease in end stage renal disease.

BACKGROUND: We sought to determine whether mitral annular calcification (MAC) predicts mortality and cardiac disease in a group of renal transplant candidates. METHODS: Hundred and forty patients were prospectively studied. All had echocardiography and coronary angiography. Significant coronary artery disease (CAD) was defined as luminal stenosis >70% by visual estimation in at least one coronary artery. RESULTS: There were 21 deaths over a follow-up period of 2.2+/-0.7 years. MAC occurred in 56 patients (40%) and was associated with higher mortality (p=0.04). Patients with MAC were older (p=or<0.001), had larger left ventricular (LV) end systolic (p=0.005) and LV end diastolic (p=0.04) diameter, larger left atrial diameter (p=0.001), lower LV fractional shortening (p=0.003), larger LV mass index (p=0.04) and higher mitral E/Ea ratio (p=0.03) compared to those without. Plasma calcium (p=0.002), phosphate (p=0.004), cardiac troponin T (p=0.03), N-terminal Pro-B-type natriuretic peptide (p=0.004) concentrations were higher in those with MAC but gender, total cholesterol, haemoglobin and creatinine were similar in the two groups. The proportion diabetic (p=0.03), on dialysis (p=0.05), with significant CAD (p=or<0.001), taking calcium containing phosphate binders (p=0.02) and Vitamin D3 (p=0.04) was significantly higher in those with MAC. Significant CAD (OR 12, 95% CI 3.25, p=0.001) was the only independent associate of MAC. CONCLUSIONS: MAC is associated with increased mortality and significant CAD in ESRD. These patients have increased LV cavity size, poorer LV systolic function, higher LV filling pressures compared to patients without MAC.

Echocardiography-based score to predict outcome after renal transplantation.

BACKGROUND: Given the high cardiac mortality of renal transplant recipients, identification of high-risk patients is important to offer appropriate treatment before transplantation. AIM: To determine patients with high mortality after renal transplantation despite selection according to current criteria. METHODS: Preoperative parameters were collected from 203 renal transplant recipients over a follow-up time of 3.6 (1.9) years. The primary end point was all-cause mortality. RESULTS: 22 deaths (11%) and 12 cardiac failures (6%) were observed. Non-survivors were older (p< or =0.001), had larger left ventricular end-systolic diameter (LVSD) (p< or =0.001) and end-diastolic diameter (p = 0.002), and lower ejection fraction (p< or =0.001). Left ventricular mass index (p = 0.001), maximal wall thickness (p = 0.006) and the proportion with mitral annular calcification (p = 0.001) were significantly higher in the non-survivors. The risk factors for ischaemic heart disease and exercise test data were not significantly different between the two groups. Four independent predictors of mortality after renal transplantation were identified: age > or =50 years (p = 0.002), LVESD > or =3.5 cm (p = 0.002), maximal wall thickness > or =1.4 cm (p = 0.014) and mitral annular calcification (p = 0.036). The 5-year survival estimates for 0, 1, 2 and 3 prognostic factors were 96%, 86%, 69% and 38%, respectively. No patient had four prognostic factors. In patients > or =50 years, the 5-year survival estimates for 0, 1 and 2 additional prognostic factors were 73%, 45% and 18%, respectively. CONCLUSION: In addition to selection according to current guidelines, age and three conventional echocardiography parameters may further improve risk stratification before renal transplantation.

Ischemia-modified albumin predicts mortality in ESRD.

BACKGROUND: The primary study aim is to determine whether ischemia-modified albumin (IMA) levels predict mortality in patients with end-stage renal disease (ESRD). The secondary aim is to determine characteristics of patients with elevated IMA levels. METHODS: A prospective observational study of 114 renal transplantation candidates was performed. All underwent coronary angiography and dobutamine stress echocardiography. The primary end point is total mortality. RESULTS: During a follow-up period of 2.25 +/- 0.71 years, there were 18 deaths; 10 were cardiac related. Diabetes, severe coronary artery disease, positive dobutamine stress echocardiography result, cardiac troponin T (cTnT) level, IMA level, left ventricular (LV) end-systolic diameter, LV ejection fraction, left atrial size, and mitral peak velocity of early filling (E)/early diastolic velocity (Ea) ratio all predicted mortality. The receiver operating characteristic area under the curve for mortality prediction was similar for IMA and cTnT levels. An IMA level of 95 KU/L or greater (n = 46) predicted mortality with a sensitivity of 76% and specificity of 74%. cTnT level of 0.06 ng/mL or greater (> or = 0.06 microg/L; n = 51) predicted mortality with a sensitivity of 75% and specificity of 72%. Thirty-eight patients (33%) had both IMA and cTnT levels elevated. With multivariate analysis, a positive dobutamine stress echocardiography result (P = 0.003), combined elevated IMA and cTnT levels (P = 0.005), and E/Ea ratio (P = 0.009) were independent prognostic factors. IMA and cTnT levels alone were not independent predictors of mortality. Patients with an elevated IMA level had a significantly larger LV size, decreased LV systolic function, and greater E/Ea ratio compared with those without an increased level. CONCLUSION: IMA level predicts mortality in patients with ESRD. Patients with elevated levels have larger LV size, decreased systolic function, and greater estimated LV filling pressures.

Mitral peak Doppler E-wave to peak mitral annulus velocity ratio is an accurate estimate of left ventricular filling pressure and predicts mortality in end-stage renal disease.

OBJECTIVE: The study aimed to assess whether the mitral peak Doppler E-wave to peak mitral annulus velocity ratio (E/Ea) estimates left ventricular (LV) filling pressure (LVFP) and predicts mortality in end-stage renal disease. METHODS: In all, 125 candidates for renal transplant were prospectively studied. LV end-diastolic pressure of 15 mm Hg or greater at cardiac catheterization was defined as elevated LVFP. RESULTS: Severe coronary artery disease, N- terminal pro-B-type natriuretic peptide level, left atrial size, flow propagation velocity, mitral E/Ea ratio, pulmonary atrial reversal velocity, and pulmonary-mitral atrial wave duration predicted an increased LVFP. However, the mitral E/Ea ratio (odds ratio 8.1, 95% confidence interval 5.1-9.6, P = .003) was the only independent predictor. An E/Ea of 15 or more, seen in 31 (25%) patients, predicted increased LVFP with sensitivity of 82% and specificity of 88%, and was associated with increased mortality (P = .005). CONCLUSIONS: In end-stage renal disease, mitral E/Ea ratio 15 or higher accurately predicts increased LVFP and mortality.

Dynamic left ventricular obstruction: a potential cause of angina in end stage renal disease.

BACKGROUND: Patients with end stage renal disease (ESRD) often have angina which cannot be explained by coronary artery disease (CAD) alone. Symptoms are often attributed to systolic and diastolic dysfunction, arrhythmia or microvascular disease. This study proposes another potential cause for angina in renal failure, namely dynamic left ventricular obstruction (LVO). METHODS: 125 renal transplant candidates underwent dobutamine stress echocardiography and coronary angiography. LVO was defined as a peak LV outflow tract gradient >50 mm Hg. RESULTS: None of the patients had LVO at rest. 15 (12%) developed obstruction with dobutamine. The mechanism was systolic anterior motion of the mitral valve in 13 and mid cavity obstruction in 2. Of 53 patients with angina, 26% had dynamic LVO compared to only 1% in those without angina (p=0.004). The proportion with severe CAD, parameters of systolic and diastolic function and haemoglobin levels were similar in patients with and without angina. Significantly more patients with obstruction had angina (93% vs 28%, p<0.001). LV end-systolic (p=0.03) and LV end-diastolic (LVEDD, p=0.03) diameter were reduced and LV fractional shortening (LVFS) increased (p= or <0.001) in those with LVO. Haemoglobin levels, septal wall thickness, estimated LV filling pressure, the proportion with a positive DSE and severe CAD were similar in the 2 groups. LVFS was independently associated with the development of significant obstruction (OR 1.12, 95% CI [1.002, 1.244] p=0.04). CONCLUSIONS: Dynamic LVO occurs in 26% of ESRD patients with angina. In these patients, the angina could not be explained by severe CAD, impaired systolic or diastolic function. Such patients have smaller LV cavity size and increased LVFS.

Dobutamine stress echocardiography and the resting but not exercise electrocardiograph predict severe coronary artery disease in renal transplant candidates.

BACKGROUND: After renal transplantation half of all deaths are cardiac, so prior detection and treatment of severe coronary artery disease (CAD) is advocated. The aim of this study was to identify non-invasive predictors of severe CAD in a group of renal transplant candidates. METHODS: One hundred and twenty-five renal transplant candidates (mean age 52+/-12 years, 80 male, mean creatinine 608+/-272 micromol/l) were studied. All had coronary angiography, dobutamine stress echocardiography, and resting and exercise electrocardiograph (ECG). Severe CAD was defined as luminal stenosis >70% by visual estimation in at least one epicardial artery. The resting ECG was recorded as abnormal if there was evidence of pathological Q waves, left ventricular hypertrophy, ST depression or elevation > or=1 mm, T wave inversion or bundle branch block. Total exercise time, maximal ST segment change, maximal heart rate and systolic blood pressure, limiting symptoms and Duke score were calculated during the exercise ECG test. RESULTS: Of the patients, 36 (29%) had severe CAD, 55% were on dialysis and 39% were diabetic. Patients with severe CAD were significantly older (P<0.001), had higher total cholesterol (P = 0.05), higher CRP level (P = 0.05), larger left ventricular (LV), end systolic and end diastolic diameter (P = 0.007 for each), and lower LV ejection fraction (P = 0.01). A significantly higher percentage were diabetic (P = 0.05), had previous graft failure (P = 0.05), mitral annular calcification (P = 0.04), an abnormal resting ECG (P = 0.001) and positive stress echo result (P<0.001). Cardiac symptoms and exercise ECG parameters were not significantly different in the two groups. Stepwise logistic regression identified an abnormal resting ECG (OR 7, 95% CI 2, 34, P = 0.013) and positive stress echo result (OR 23, 95% CI 6, 88, P<0.001) as independent predictors of severe CAD. CONCLUSIONS: In selecting which potential renal transplant candidates should undergo coronary angiography, resting ECG and dobutamine stress echocardiography are the best predictors of severe CAD.

Management of acute coronary syndromes.

Acute coronary syndromes represent the acute, life-threatening phases of coronary heart disease. Patients with acute coronary syndromes are at high risk of major adverse cardiac events. Treatment of these patients remains controversial because of the heterogeneous nature of these conditions and recent advances in their management options. The older standbys of aspirin, heparins, nitrates, beta-blockers, and thrombolytic therapy have given way to vastly improved interventional capabilities (with improved adjunctive pharmacotherapy), low molecular weight heparins, glycoprotein IIb/IIIa antagonists, safer theinopyridines, thrombin inhibitors, and newer generation fibrinolytics. Despite these substantial advances, a great deal of confusion remains. Clinicians know that there are better forms of therapy but are not sure how to use them, when to use them, or even what to use. They do not have all the answers at present and probably have more questions than answers.