Prosthesis-patient mismatch after transcatheter aortic valve implantation with the Medtronic-Corevalve bioprosthesis

Aims: Prosthesis-patient mismatch (P-PM) is an important determinant of morbidity and mortality following open aortic valve replacement. The aims of this study were to report its incidence and determinants following transcatheter aortic valve implantation (TAVI) with the Corevalve bioprosthesis, which have—thus far—not been described. Methods and results: Patients with severe calcific aortic stenosis received TAVI with the Corevalve bioprosthesis via transfemoral route. Following TAVI, moderate P-PM was defined as indexed aortic valve effective orifice area (AVAi) ≤0.85 cm2/m2 and severe P-PM as AVAi ≤0.65 cm2/m2. Clinical, echocardiographic, and procedural factors relating to P-PM were studied. Optimal device position was defined on fluoroscopy as final position of the proximal aspect of the Corevalve stent frame 5–10 mm below the native aortic annulus. Between January 2007 and January 2009, 50 consecutive patients underwent TAVI in a single centre with the Corevalve bioprosthesis. Mean age was 82.8 years (SD 5.9; 70–93) and 48% were male. P-PM occurred in 16 of 50 cases (32%). Optimal position was achieved in 50% of cases. P-PM was unrelated to age, annulus size, LVOT size, Corevalve size, aortic angulation, ejection fraction, and sex. It was inversely correlated to optimal position (Spearman rho r = −0.34, P = 0.015). Those with optimal positioning had a 16% incidence of P-PM relative to 48% of those with suboptimal positioning (Pearson χ2P = 0.015). Conclusion: The incidence of P-PM following TAVI with the Corevalve bioprosthesis is compared favourably with that seen after AVR with conventional open stented bioprostheses and its occurrence is influenced by device positioning

Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation

OBJECTIVES: Atrial fibrillation (AF) reduces survival and quality of life (QoL). It can be treated at the time of major cardiac surgery using ablation procedures ranging from simple pulmonary vein isolation to a full maze procedure. The aim of this study is to evaluate the impact of adjunct AF surgery as currently performed on sinus rhythm (SR) restoration, survival, QoL and costeffectiveness. METHODS: In a multicentre, Phase III, pragmatic, double-blinded, parallel-armed randomized controlled trial, 352 cardiac surgery patients with >3 months of documented AF were randomized to surgery with or without adjunct maze or similar AF ablation between 2009 and 2014. Primary outcomes were SR restoration at 1 year and quality-adjusted life years at 2 years. Secondary outcomes included SR at 2 years, overall and stroke-free survival, medication, QoL, cost-effectiveness and safety. RESULTS: More ablation patients were in SR at 1 year [odds ratio (OR) 2.06, 95% confidence interval (CI) 1.20–3.54; P = 0.009]. At 2 years, the OR increased to 3.24 (95% CI 1.76–5.96). Quality-adjusted life years were similar at 2 years (ablation - control -0.025, P = 0.6319). Significantly fewer ablation patients were anticoagulated from 6 months postoperatively. Stroke rates were 5.7% (ablation) and 9.1% (control) (P = 0.3083). There was no significant difference in stroke-free survival [hazard ratio (HR) = 0.99, 95% CI 0.64–1.53; P = 0.949] nor in serious adverse events, operative or overall survival, cardioversion, pacemaker implantation, New York Heart Association, EQ-5D-3L and SF-36. The mean additional ablation cost per patient was £3533 (95% CI £1321–£5746). Cost-effectiveness was not demonstrated at 2 years. CONCLUSIONS: Adjunct AF surgery is safe and increases SR restoration and costs but not survival or QoL up to 2 years. A continued follow-up will provide information on these outcomes in the longer term

Early regression of left ventricular wall thickness following percutaneous aortic valve replacement with the CoreValve bioprosthesis.

Background: Severe aortic stenosis (AS) is associated with hypertrophy of the left ventricle (LVH), which is linked to adverse clinical outcomes. To date, the effects of the novel technology of percutaneous aortic valve replacement (PAVR) on LVH in severe AS have not been described. We sought to test the hypothesis that PAVR would result in regression of LVH associated with severe AS. Methods: Patients were recruited as part of a single-arm, prospective, safety, feasibility and clinical outcome study of the third-generation CoreValve percutaneous aortic bioprosthesis. To assess hypertrophy at baseline and at 1 month, the parasternal long-axis view in end-diastole was used to assess interventricular septal dimension and left ventricular posterior wall dimension. Results: 15 patients were studied. There were significant periprocedural reductions in peak (76.6 +/- 28.1 mmHg to 16.3 +/- 7.5 mmHg; p \u3c 0.001) and mean (45.3 +/- 18.4 mmHg to 8.2 +/- 3.7 mmHg; p = 0.001) transvalvular gradients and increases in calculated aortic valve areas (0.73 +/- 0.19 cm2 to 1.5 +/- 0.3 cm2). Septal wall thickness regressed by 13% from 1.54 +/- 0.30 cm at baseline to 1.35 +/- 0.27 cm at 1 month (for difference; p = 0.002). Conclusion: We demonstrate an early regression of septal hypertrophy after PAVR for severe AS which is comparable to that seen at 1 year after conventional surgical aortic valve replacemen

Comparison of Complete Versus Incomplete Stent Frame Expansion After Transcatheter Aortic Valve Implantation With Medtronic Coke Valve Bioprosthesis

We sought to determine the significance of incomplete stent frame expansion after transcatheter aortic valve implantation with the Medtronic-CoreValve device. Incomplete coronary stent expansion is a well-described phenomenon. Transcatheter valves are mounted on stents; however, the incidence of incomplete stent expansion after transcatheter aortic valve implantation, its sequelae and predictors are poorly elucidated. The 18Fr CoreValve revalving system was used to treat anatomically and clinically suitable patients with severe calcific aortic stenosis. The postdeployment stent dimensions were measured on fluoroscopic images at multiple levels of the stent frame. Incomplete expansion at each was defined a

Predictors for permanent pacemaker requirement after transcatheter aortic valve implantation with the CoreValve bioprosthesi

Introduction: Changes in atrioventricular (AV) conduction and need for permanent pacemaker (PPM) are a recognized complication after open aortic valve replacement. We hypothesized that the need for PPM after CoreValve (Corevalve Inc, Irvine, CA) can be predicted with a combination of baseline variables. Methods: In patients undergoing transcatheter aortic valve implantation, potential clinical, electrocardiographic and echocardiographic predictors of permanent pacing requirement were studied. Results: Between January 2007 and March 2008, 34 patients with severe symptomatic aortic stenosis were recruited in a single center. Mean age was 84.4 years (SD 5.4, range 71-93). Of 34 cases paced at baseline, 3 (8.8%) were excluded from this analysis, as was the single periprocedural mortality. Of the remaining 30, 10 underwent permanent pacemaker implantation during the same admission (33.3%). PPM was for prolonged high-grade AV block in 4 cases, episodic high-grade AV block in 5, and sinus node disease in 1. Need for pacemaker was correlated to left axis deviation at baseline ( P = .004, r = 0.508) and left bundle-branch block with left axis deviation ( P = .002, r = 0.548). It was related to diastolic interventricular septal dimension on transthoracic echocardiography \u3e17 mm ( P = .045, r = 0.39) and the baseline thickness of the native noncoronary cusp ( P = .002, r = 0.655). A susceptibility model was generated, and if at least one of (1) left bundle-branch block with left axis deviation, (2) interventricular septal dimension \u3e17 mm, or (3) noncoronary cusp thickness \u3e8 mm was present, the likelihood of PPM could be predicted with 75% sensitivity and 100% specificity and a receiver operating characteristic curve area of 0.93 ± 0.055 ( P \u3c .001). Conclusions: After transcatheter aortic valve implantation with CoreValve, permanent pacing was performed in around a third of patients and we present preliminary concepts towards a predictive model for this phenomenon

Non-invasive measurement of peripheral venous oxygen saturation using a new venous oximetry method: evaluation during bypass in heart surgery

Monitoring of mixed venous oxygen saturation (SvO2) is currently performed using invasive fibre-optic catheters. This procedure is not without risk as complications may arise from catheterization. This paper describes an alternative, non-invasive method of monitoring peripheral venous oxygen saturation (SxvO2) which, although it cannot replace pulmonary artery catheters, can serve as an adjunct/early warning indicator of when there is an imbalance in oxygen supply and demand. The technique requires the generation of an artificial venous pulse at the finger, thereby causing modulation of the venous blood volume within the digit. The blood volume changes aremonitored using an optical sensor. Just as pulse oximetry utilizes the natural arterial pulse to perform a spectrophotometric analysis of the peripheral blood in order to estimate the arterial blood oxygen saturation, the proposed venous oximetry technique uses the artificially generated venous pulse to estimate SxvO2. A prototype device was tested in a pilot study with patients undergoing heart surgery. Data from this study support the notion that the method is capable of tracking haemodynamic changes and suggests the technique is worthy of further development and evaluation