Nikolaus Jander

Randomized Evaluation of the Effects of Filter-Based Distal Protection on Myocardial Perfusion and Infarct Size After Primary Percutaneous Catheter Intervention in Myocardial Infarction With and Without ST-Segment Elevation

Background—In acute myocardial infarction, distal embolization of debris during primary percutaneous catheter intervention may curtail microvascular reperfusion of the infarct region. Our randomized trial investigated whether distal protection with a filter device can improve microvascular perfusion and reduce infarct size after primary percutaneous catheter intervention. Methods and Results—We enrolled 200 patients who had angina within 48 hours after onset of pain plus at least 1 of 3 additional criteria: ST-segment elevation, elevated myocardial marker proteins, and angiographic evidence of thrombotic occlusion. Among the patients included (83% men; mean age, 62±12 years), 100 were randomly assigned to the filter-wire group and 100 to the control group. The primary end point was the maximal adenosine-induced Doppler flow velocity in the recanalized infarct artery; the secondary end point was infarct size estimated by the volume of delayed enhancement on nuclear MRI. ST-segment elevation myocardial infarction was present in 68.5% of the patients; the median time from onset of pain was 6.9 hours. In the filter-wire group, maximal adenosine-induced flow velocity was 34±17 compared with 36±20 cm/s in the control group (P=0.46). Infarct sizes, assessed in 82 patients in the filter-wire group and 78 patients in the control group, were 11.8±9.3% of the left ventricular mass in the filter-wire group and 10.4±9.4% in the control group (P=0.33). Thirty-day mortality was 2% in filter-wire group and 3% in the control group. Conclusions—The filter wire as an adjunct to primary percutaneous catheter intervention in myocardial infarction with and without ST-segment elevation did not improve reperfusion or reduce infarct size.

Outcome of Patients With Low-Gradient “Severe” Aortic Stenosis and Preserved Ejection Fraction

Background— Retrospective studies have suggested that patients with a low transvalvular gradient in the presence of an aortic valve area <1.0 cm2 and normal ejection fraction may represent a subgroup with an advanced stage of aortic valve disease, reduced stroke volume, and poor prognosis requiring early surgery. We therefore evaluated the outcome of patients with low-gradient “severe” stenosis (defined as aortic valve area <1.0 cm2 and mean gradient ⩽40 mm Hg) in the prospective Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study. Methods and Results— Outcome in patients with low-gradient “severe” aortic stenosis was compared with outcome in patients with moderate stenosis (aortic valve area 1.0 to 1.5 cm2; mean gradient 25 to 40 mm Hg). The primary end point of aortic valve events included death from cardiovascular causes, aortic valve replacement, and heart failure due to aortic stenosis. Secondary end points were major cardiovascular events and cardiovascular death. In 1525 asymptomatic patients (mean age, 67±10 years; ejection fraction, ≥55%), baseline echocardiography revealed low-gradient severe stenosis in 435 patients (29%) and moderate stenosis in 184 (12%). Left ventricular mass was lower in patients with low-gradient severe stenosis than in those with moderate stenosis (182±64 versus 212±68 g; P<0.01). During 46 months of follow-up, aortic valve events occurred in 48.5% versus 44.6%, respectively (P=0.37; major cardiovascular events, 50.9% versus 48.5%, P=0.58; cardiovascular death, 7.8% versus 4.9%, P=0.19). Low-gradient severe stenosis patients with reduced stroke volume index (⩽35 mL/m2; n=223) had aortic valve events comparable to those in patients with normal stroke volume index (46.2% versus 50.9%; P=0.53). Conclusions— Patients with low-gradient “severe” aortic stenosis and normal ejection fraction have an outcome similar to that in patients with moderate stenosis.

Outcome of Patients With Low-Gradient “Severe” Aortic Stenosis and Preserved Ejection Fraction The Heart Strategies Concentrating on Risk Evaluation (Heart SCORE) Study

Background— Retrospective studies have suggested that patients with a low transvalvular gradient in the presence of an aortic valve area <1.0 cm2 and normal ejection fraction may represent a subgroup with an advanced stage of aortic valve disease, reduced stroke volume, and poor prognosis requiring early surgery. We therefore evaluated the outcome of patients with low-gradient “severe” stenosis (defined as aortic valve area <1.0 cm2 and mean gradient ⩽40 mm Hg) in the prospective Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study. Methods and Results— Outcome in patients with low-gradient “severe” aortic stenosis was compared with outcome in patients with moderate stenosis (aortic valve area 1.0 to 1.5 cm2; mean gradient 25 to 40 mm Hg). The primary end point of aortic valve events included death from cardiovascular causes, aortic valve replacement, and heart failure due to aortic stenosis. Secondary end points were major cardiovascular events and cardiovascular death. In 1525 asymptomatic patients (mean age, 67±10 years; ejection fraction, ≥55%), baseline echocardiography revealed low-gradient severe stenosis in 435 patients (29%) and moderate stenosis in 184 (12%). Left ventricular mass was lower in patients with low-gradient severe stenosis than in those with moderate stenosis (182±64 versus 212±68 g; P<0.01). During 46 months of follow-up, aortic valve events occurred in 48.5% versus 44.6%, respectively (P=0.37; major cardiovascular events, 50.9% versus 48.5%, P=0.58; cardiovascular death, 7.8% versus 4.9%, P=0.19). Low-gradient severe stenosis patients with reduced stroke volume index (⩽35 mL/m2; n=223) had aortic valve events comparable to those in patients with normal stroke volume index (46.2% versus 50.9%; P=0.53). Conclusions— Patients with low-gradient “severe” aortic stenosis and normal ejection fraction have an outcome similar to that in patients with moderate stenosis.

Inconsistent grading of aortic valve stenosis by current guidelines: haemodynamic studies in patients with apparently normal left ventricular function

Background On echocardiography approximately one-third of patients with severe aortic valve stenosis based on aortic valve area (AVA<1.0 cm2) demonstrate a non-severe mean pressure gradient (ΔPm; ≤40 mm Hg) despite apparently normal left ventricular function. It has been suggested that inconsistent echocardiographic grading may be due to ‘paradoxical’ low stroke volume. However, the correct echocardiographic assessment of stroke volume hinges on the often problematic measurement of the left ventricular outflow tract (LVOT) diameter. Objective To investigate whether inconsistent grading and reduced stroke volume persist when the quantification of aortic valve stenosis is based on cardiac catheterisation which is independent of LVOT measurements. Methods and results 333 consecutive patients underwent cardiac catheterisation within 30 days after their index echocardiography showing an AVA ≤2 cm2 and shortening fraction ≥30%. On invasive testing 85 patients (26%) demonstrated inconsistent (AVA<1 cm2 and ΔPm≤40 mm Hg) and 153 (46%) consistent grading (AVA<1 cm2 and ΔPm>40 mm Hg) with the remainder (28%) presenting with a calculated AVA≥1 cm2. Inconsistently graded patients were older (71 vs 67 years, p<0.006) with no differences in sex or body surface area between groups. Stroke volume and stroke volume index were significantly lower in inconsistently graded patients (63±14 vs 73±18 ml and 35±7 vs 39±7 ml/m2, respectively, both p<0.001). However, 41/85 (48%) of inconsistently graded patients had a normal stroke volume index >35 ml/m2. Conclusion In the framework of current guidelines inconsistent grading of aortic valve stenosis is common, extends to cardiac catheterisation and is only partially explained by low stroke volume despite apparently normal left ventricular systolic function.

Incidence of pulmonary vein stenosis 2 years after radiofrequency catheter ablation of refractory atrial fibrillation

AIMS Pulmonary vein ablation offers the potential to cure patients with atrial fibrillation. In this study, we investigated the incidence of pulmonary vein stenosis after radiofrequency catheter ablation of refractory atrial fibrillation by systematic long-term follow-up. METHODS AND RESULTS Forty-seven patients with refractory and highly symptomatic atrial fibrillation underwent radiofrequency catheter ablation of arrhythmogenic triggers inside the pulmonary veins and/or ostial pulmonary vein isolation with conventional mapping and ablation technology. These patients had follow-up examinations at 2 years with transoesophageal doppler-echo and/or angio magnetic resonance imaging for the evaluation of the pulmonary veins. Seventy-seven percent of the patients were free from atrial fibrillation, 51% were without antiarrhythmic drugs, and 26% were on previously ineffective antiarrhythmic drug therapy. However, 13 of the 47 patients showed significant pulmonary vein stenosis or occlusion. Only three of these 13 patients complained of dyspnoea. Distal ablations inside the pulmonary vein were associated with a 5.6-fold higher risk of stenosis than ostial ablations. CONCLUSIONS At 2-year follow-up, the risk of significant pulmonary vein stenosis/occlusion after radiofrequency catheter ablation of refractory atrial fibrillation with conventional mapping and ablation technology was 28%. Distal ablations inside smaller pulmonary veins should be avoided because of the higher risk of stenosis than ablation at the ostium.

Feasibility and Safety of Pulmonary Vein Isolation Using a New Mapping and Navigation System in Patients With Refractory Atrial Fibrillation

Background—Ostial pulmonary vein (PV) isolation by radiofrequency (RF) catheter ablation can cure patients with atrial fibrillation (AF); however, this procedure carries the risk of PV stenosis. The aim of this study was to assess the feasibility of a new mapping and navigation technique using a multipolar basket catheter (BC) for PV isolation in patients with refractory AF and to analyze its safety with regard to PV stenosis at long-term follow-up. Methods and Results—We studied 55 patients (mean age, 53±11 years; 40 male) with drug-refractory AF (paroxysmal, n=37; persistent, n=18). A 64-pole BC was placed transseptally into each of the accessible PVs. By use of a nonfluoroscopic navigation system, the ablation catheter was guided to the BC electrodes at the PV ostium, with earliest activation during sinus rhythm. RF was delivered by use of maximum settings of temperature at 50°C and power at 30 W. The end point of the procedure was the complete elimination of all distal and fragmented ostial PV potentials. Of 165 targeted veins, 163 were successfully isolated with a mean RF duration of 720±301 seconds per vein. At 1-year follow-up, 62% of the patients were in sinus rhythm without antiarrhythmic drugs. Contrast-enhanced magnetic resonance angiography revealed 2 PV stenoses of >25% out of 165 treated vessels. Conclusions—The use of a multipolar BC allowed effective and safe PV isolation by combining 3D mapping and navigation. At 1-year follow-up, 62% of the patients were in sinus rhythm without antiarrhythmic drugs, and the incidence of relevant diameter reduction of the treated PVs was 1.2%.

Early hypo-attenuated leaflet thickening in balloon-expandable transcatheter aortic heart valves

AIMS We sought to evaluate the frequency of early hypo-attenuated leaflet thickening (HALT) of the SAPIEN 3 transcatheter aortic valve (S3). METHODS AND RESULTS Of 249 patients who had undergone S3 implantation, we studied 156 consecutive patients (85 women, median age 82.2 ± 5.5 years) by electrocardiogram (ECG)-triggered dual-source computed tomography angiography (CTA) after a median of 5 days post-transcatheter aortic valve implantation. The prosthesis was assessed for HALT. Apart from heparin, peri-interventional antithrombotic therapy consisted of single- (aspirin 29%) or dual- (aspirin plus clopidogrel 71%) antiplatelet therapy. Hypo-attenuated leaflet thickening was found in 16 patients [10.3% (95% confidence interval (CI) 5.5-15.0%)] of the patients. None of the baseline and procedural variables were significantly associated with HALT, nor did we find a significant association with the antithrombotic regimen, either peri-interventionally or at the time of CTA. Hypo-attenuated leaflet thickening was found in 6 of 45 patients with peri-interventional single-antiplatelet therapy and in 10 of 111 patients with dual-antiplatelet therapy at the time of intervention [13.3% (95% CI 3.4-23.3%) vs. 9% (95% CI 3.7-14.3%), P = 0.42]. Hypo-attenuated leaflet thickening was not associated with clinical symptoms, but a small, albeit significant difference in mean pressure gradient at the time of CTA (11.6 ± 3.4 vs. 14.9 ± 5.3 mmHg, P = 0.026). Full anticoagulation led to almost complete resolution of HALT in 13 patients with follow-up CTA. CONCLUSION Irrespective of the antiplatelet regimen, early HALT occurred in 10% of our patients undergoing transcatheter aortic S3 implantation. Early HALT is clinically inapparent and reversible by full anticoagulation.

Pulmonary capillary wedge pressure during exercise and long-term mortality in patients with suspected heart failure with preserved ejection fraction

AIMS In patients with suspected heart failure with preserved ejection fraction (HFpEF), invasive exercise testing may be considered when measurements at rest are inconclusive. However, the prognostic impact of invasive exercise testing is uncertain, so far. METHODS AND RESULTS We retrospectively analysed mortality in 355 patients [mean age 61.2 ± 11.3 years, 235 (66.2%) women] with unexplained dyspnoea and suspected HFpEF. During an invasive haemodynamic stress test pulmonary capillary wedge pressure (PCWP) at rest and the PCWP response to exercise, expressed as the ratio of PCWP at peak exercise to workload normalized to body weight [PCWL (mmHg/W/kg)], were recorded. Both PCWP at rest and PCWL were significant and independent predictors of long-term mortality. Adding PCWL to PCWP at rest improved reclassification of patients into survivors or non-survivors with a net reclassification improvement (NRI) of 0.56 (95% CI: 0.29-0.83; P < 0.001). Ten-year mortality was 6.6% in subjects with low PCWP at rest (≤ 12 mmHg) and low PCWL (≤ 25.5 mmHg/W/kg); 28.2% in patients with low PCWP and high PCWL and 35.2% in those with high PCWP and high PCWL. Compared with patients with low PCWP and low PCWL, the adjusted hazard ratio for mortality was 2.37 (95% CI: 1.09-5.17; P = 0.029) for the low-PCWP/high-PCWL group and 4.75 (95% CI: 1.90-11.84; P < 0.001) for patients with high PCWP/high PCWL. CONCLUSION In patients with suspected HFpEF, invasive exercise testing substantially improves prediction of long-term mortality. An excessive rise of PCWP during exercise despite normal PCWP at rest is associated with increased mortality and may be considered as early HFpEF.

Cusp thrombosis after transcatheter aortic valve replacement detected by computed tomography and echocardiography

An 86-year-old male underwent transcatheter aortic valve replacement (TAVR) for severe aortic stenosis with an Edwards Sapien 29 mm XT valve and percutaneous coronary intervention simultaneously. Periprocedural transoesophageal echocardiography (TOE) showed good positioning and expansion of the prosthesis with only minor paravalvular insufficiency. Routine …

Indexing aortic valve area by body surface area increases the prevalence of severe aortic stenosis

Background To account for differences in body size in patients with aortic stenosis, aortic valve area (AVA) is divided by body surface area (BSA) to calculate indexed AVA (AVAindex). Cut-off values for severe stenosis are <1.0 cm2 for AVA and <0.6 cm2/m2 for AVAindex. Objective To investigate the influence of indexation on the prevalence of severe aortic stenosis and on the predictive accuracy regarding clinical outcome. Methods Echocardiographic and anthropometric data from a retrospective cohort of 2843 patients with aortic stenosis (jet velocity >2.5 m/s) and from 1525 patients prospectively followed in the simvastatin and ezetimibe in aortic stenosis (SEAS) trial were analysed. Results The prevalence of severe stenosis increased with the AVAindex criterion compared to AVA from 71% to 80% in the retrospective cohort, and from 29% to 44% in SEAS (both p<0.001). Overall, the predictive accuracy for aortic valve events was virtually identical for AVA and AVAindex in the SEAS population (mean follow-up of 46 months; area under the receiver operating characteristic curve: 0.67 (95% CI 0.64 to 0.70) vs 0.68 (CI 0.65 to 0.71) (NS). However, 213 patients additionally categorised as severe by AVAindex experienced significantly less valve related events than those fulfilling only the AVA criterion (p<0.001). Conclusions Indexing AVA by BSA (AVAindex) significantly increases the prevalence of patients with criteria for severe stenosis by including patients with a milder degree of the disease without improving the predictive accuracy for aortic valve related events.