AIMS:Sex-specific low flow was recently defined as stroke volume index (SVi) ≤ 40 mL/m² in men and ≤32 mL/m² in women. We tested the prognostic association of these cut-offs in patients with aortic stenosis (AS) with concordantly and discordantly graded AS [concordantly graded AS by energy loss (CGASEL) and discordantly graded AS by energy loss (DGASEL)] based on pressure recovery adjusted aortic valve area [energy loss (EL)]. METHODS AND RESULTS:Data from 1351 patients with asymptomatic AS, peak jet velocity <4 m/s, and preserved left ventricular ejection fraction enrolled in the Simvastatin and Ezetimibe in Aortic Stenosis study were used. DGASEL was defined as EL <1.0 cm² with mean aortic gradient <40 mmHg and CGASEL as EL ≥1.0 cm² with mean aortic gradient <40 mmHg. Patients were further grouped into normal and low flow. The outcome was combined all-cause death and hospitalization for heart failure (HF). CGASEL with normal/low flow was present in 915/253 patients, and DGASEL with normal/low flow was present in 57/126 patients. During a median follow-up of 4.3 years, event-free survival was lower in patients with DGASEL irrespective of flow compared to CGASEL with normal flow (P < 0.05). In Cox regression analysis, DGASEL with normal or low flow were both associated with increased risk of all-cause death and hospitalization for HF after adjustment for age, sex, heart rate, randomized study treatment, hypertension, aortic valve replacement, and aortic valve calcification (P < 0.05). No survival difference was found between patients with normal vs. low flow within groups of DGASEL or CGASEL. CONCLUSION:Identification of low flow by the proposed sex-specific thresholds of SVi needs more prognostic validation before application in clinical practice. CLINICALTRIALS.GOV IDENTIFIER:NCT00092677.

IntroductionThe use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) in extracorporeal cardiopulmonary resuscitation (eCPR) has emerged as a treatment option for selected patients who are experiencing refractory cardiac arrest (CA). In the light of increasing availability, the analyses of outcome-relevant predisposing characteristics are of growing importance. We evaluated the prognostic influence of gender in patients presenting with out-of-hospital cardiac arrest (OHCA) treated with eCPR.MethodsWe retrospectively analysed the data of 377 consecutive patients treated for OHCA using eCPR in our cardiac arrest centre from January 2016 to December 2022. The primary outcome was defined as the survival of patients until they were discharged from the hospital, with a favourable neurological outcome [cerebral performance category (CPC) score of ≤2]. Statistical analyses were performed using baseline comparison, survival analysis, and multivariable analyses.ResultsOut of the 377 patients included in the study, 69 (21%) were female. Female patients showed a lower prevalence rate of pre-existing coronary artery disease (48% vs. 75%, p < 0.001) and cardiomyopathy (17% vs. 34%, p = 0.01) compared with the male patients, while the mean age and prevalence rate of other cardiovascular risk factors were balanced. The primary reason for CA differed significantly (female: coronary event 45%, pulmonary embolism 23%, cardiogenic shock 17%; male: coronary event 70%, primary arrhythmia 10%, cardiogenic shock 10%; p = 0.001). The prevalence rate of witnessed collapse (97% vs. 86%; p = 0.016) and performance of bystander CPR (94% vs. 85%; p = 0.065) was higher in female patients. The mean time from collapse to the initiation of eCPR did not differ between the two groups (77 ± 39 min vs. 80 ± 37 min; p = 0.61). Overall, female patients showed a higher percentage of neurologically favourable survival (23% vs. 12%; p = 0.027) despite a higher prevalence of procedure-associated bleeding complications (33% vs. 16%, p = 0.002). The multivariable analysis identified a shorter total CPR duration (p = 0.001) and performance of bystander CPR (p = 0.03) to be associated with superior neurological outcomes. The bivariate analysis showed relevant interactions between gender and body mass index (BMI).ConclusionOur analysis suggests a significant survival benefit for female patients who obtain eCPR, possibly driven by a higher prevalence of witnessed collapse and bystander CPR. Interestingly, the impact of patient age and BMI on neurologically favourable outcome was higher in female patients than in male patients, warranting further investigation.

IntroductionThe use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) in extracorporeal cardiopulmonary resuscitation (ECPR) in selected patients after out-of-hospital cardiac arrest (OHCA) is an established method if return of spontaneous circulation cannot be achieved. Automated chest compression devices (ACCD) facilitate transportation of patients under ongoing CPR and might improve outcome. We thus sought to evaluate prognostic influence of mechanical CPR using ACCD in patients presenting with OHCA treated with ECPR including VA-ECMO.MethodsWe retrospectively analyzed data of 171 consecutive patients treated for OHCA using ECPR in our cardiac arrest center from the years 2016 to 2022. A Cox proportional hazards model was used to identify characteristics related with survival.ResultsOf the 171 analyzed patients (84% male, mean age 56 years), 12% survived the initial hospitalization with favorable neurological outcome. The primary reason for OHCA was an acute coronary event (72%) followed by primary arrhythmia (9%) and non-ischemic cardiogenic shock (6.7%). In most cases, the collapse was witnessed (83%) and bystander CPR was performed (83%). The median time from collapse to VA-ECMO was 81 min (Q1: 69 min, Q3: 98 min). No survival benefit was seen for patients resuscitated using ACCD. Patients in whom an ACCD was used presented with overall longer times from collapse to ECMO than those who were resuscitated manually [83 min (Q1: 70 min, Q3: 98 min) vs. 69 min (Q1: 57 min, Q3: 84 min), p = 0.004].ConclusionNo overall survival benefit of the use of ACCD before ECPR is established was found, possibly due to longer overall CPR duration. This may arguably be because of the limited availability of ACCD in pre-clinical paramedic service at the time of observation. Increasing the availability of these devices might thus improve treatment of OHCA, presumably by providing efficient CPR during transportation and transfer.

Background: The importance of pulmonary artery pressure recovery (PR) in patients with Ross procedures in whom a homograft substitutes the resected pulmonary valve, is unknown. The aim of the study was to evaluate the occurrence and extent of PR in the pulmonary artery in 65 asymptomatic patients with pulmonary homograft after Ross surgery during rest and exercise. Methods: Stress echocardiography was performed in 65 pulmonary homograft patients and 31 controls with native pulmonary valves up to 75 watts (W). Right ventricular systolic pressure (RVSP), transvalvular flow, mean pressure gradient (P ), valve resistance and RV stroke work were determined in the exercise (max. 75 W) and recovery phases in increments of 25W each. Results: Pulmonary homografts demonstrated significantly elevated P compared to controls at all stages. When considering pressure recovery (absolute and relative PR at rest 3.8+/-1.8 mmHg, 42.6+/-7.2%, respectively) and transvalvular energy loss (EL; at rest 4.5+/-4.3 mmHg) the homograft hemodynamics reached the level of controls. In a subgroup of patients with tricuspid regurgitation, resting RVSP was the same in homograft patients and controls (21.3 +/- 6.1 vs. 20.4 +/- 6.3, p=0.62), despite significant different P values. Conclusions: Ross patients with pulmonary homograft showed systematically increased hemodynamic parameters compared to normal pulmonary valves. These differences were abolished when PR was considered for homograft patients. The equality of RVSP values at rest in both groups shows non-invasive evidence for PR in the pulmonary system after homograft implantation. Therefore, PR appears to be an important measure in calculating the actual hemodynamics in pulmonary homografts.

Background:Lymphocytic myocarditis is a rare form of myocarditis, associated with a high mortality rate due to a high risk of sudden cardiac death. Lymphocytic myocarditis might present as a relevant extrapulmonary manifestation after coronavirus disease 2019 (COVID-19) infection. Case presentation. We report a case of a 26-year-old male with lymphocytic myocarditis, presenting with a 1-month history of increasing fatigue, palpitations, and shortness of breath. Eight weeks before, he was tested positive for SARS-CoV-2. He had received 2-dose schedule of the COVID-19 mRNA vaccine Comirnaty® (BioNTech/Pfizer) 6 months prior to his admission. Diagnostic work-up by echocardiography and cardiac magnetic resonance (CMR) imaging demonstrated a severely reduced left ventricular function and a strong midmyocardial late gadolinium enhancement (LGE). Histology and immunohistology of the endomyocardial biopsies revealed an acute lymphocytic myocarditis. Immunosuppressive therapy with a steroid taper in combination with azathioprine 300 mg/day was initiated. The patient was equipped with a LifeVest®. On day 17, a non-sustained ventricular tachycardia was documented. Follow-up CMR imaging after 3 months showed a slightly improved systolic left ventricular function, and a strong LGE was still detectable. Conclusions:The case highlights the significance of recognizing lymphocytic myocarditis correlated to COVID-19. It is important to be vigilant also of a later presentation of cardiomyopathy in patients diagnosed with COVID-19 due to high mortality without immediate support.

AbstractRelevant pressure recovery (PR) has been shown to increase functional stenotic aortic valve orifice area and reduce left ventricular load. However, little is known about the relevance of PR in the pulmonary artery. The study examined the impact of PR using 2D‐echocardiography in the pulmonary artery distal to the degenerated homograft in patients after Ross surgery. Ninety‐two patients with pulmonary homograft were investigated by Doppler echocardiography (mean time interval after surgery 31 ± 26 months). PR was measured as a function of pulmonary artery diameter determined by computed tomography angiography. Homograft orifice area, valve resistance, and transvalvular stroke work were calculated with and without considering PR. PR decreased as the pulmonary artery diameter increased (r = −0.69, p < 0.001). Mean PR was 41.5 ± 7.1% of the Doppler‐derived pressure gradient (Pmax), which resulted in a markedly increased homograft orifice area (energy loss coefficient index [ELCOI] vs. effective orifice area index [EOAI], 1.3 ± 0.4 cm2/m2 vs. 0.9 ± 0.4 cm2/m2, p < 0.001). PR significantly reduced homograft resistance and transvalvular stroke work (822 ± 433 vs. 349 ± 220 mmHg × ml, p < 0.0001). When PR was considered, the correlations of the parameters used were significantly better, and 11 of 18 patients (61%) in the group with severe homograft stenosis (EOAI <0.6 cm2/m2) could be reclassified as moderate stenosis. Our results showed that the Doppler measurements overestimated the degree of homograft stenosis and thus the right ventricular load, when PR was neglected in the pulmonary artery. Therefore, Doppler measurements that ignore PR can misclassify homograft stenosis and may lead to premature surgery.

Objective We hypothesised that patients with asymptomatic aortic stenosis (AS) who remain with discordantly graded aortic valve stenosis (DGAS) after adjustment for pressure recovery in the aortic root represents a subgroup of patients with increased cardiovascular risk. Methods Data from 1353 patients with asymptomatic mild–moderate AS and preserved left ventricular ejection fraction enrolled in the Simvastatin and Ezetimibe in AS study was used. DGAS was identified as combined pressure adjusted valve area (energy loss) <1.0 cm² and mean aortic gradient<40 mm Hg (DGAS EL ). Outcome was assessed in Cox regression analysis and reported as HR and 95% CI. Results DGAS EL was found in 196 (14.5%) patients at baseline, and was associated with older age, female sex, smaller aortic annulus diameter, lower heart rate, more extensive valve calcification and low flow (all p<0.05). In Cox regression analysis, DGAS EL was associated with higher rate of heart failure (HF) hospitalisation (HR 3.31 (95% CI 1.54 to 7.09)), cardiovascular death (HR 2.63 (95% CI 1.34 to 5.17)) and all-cause mortality (HR 1.73 (95% CI 1.04 to 2.87)) independent of confounders including low flow and aortic valve calcification (all p<0.05). Conclusions Patients with asymptomatic AS who remain with discordant grading after adjustment for pressure recovery have increased risk for HF and death. Trial registration number NCT00092677 .

Aortic stenosis (AS) is the most common degenerative valvular disease in western word. In patients with severe AS, small changes in aortic valve area can lead to large changes in hemodynamics. The correct understanding of cardiac hemodynamics and its interaction with vascular function is of paramount importance for correct identification of severe AS and to plan effective strategies for its treatment. In the current review with highlight the importance of pressure recovery phenomenon and valvular arterial impedance as novel tools in the evaluation of patients with aortic stenosis.

Aortic stenosis (AS) is the most common valvular heart disease and the main indication for valvular replacement in older women. Correct AS grading is mandatory for an adequate selection of patients for both surgical and transcatheter aortic valve replacement. Women and men have different AS severity grades at the same level of aortic valve calcification. Moreover, besides having smaller cardiac volumes, left ventricular outflow tract and aortic size, women have a specific pattern of left ventricular structural and functional remodelling in response to the AS-related chronic pressure overload. Here, the sex-specific cardiac changes in AS that make AS grading more challenging in women, with consequences for the management and outcome of this group of patients, are reviewed.

Background Loeffler-endocarditis (LE) is considered a chronic restrictive cardiomyopathy and manifestation of eosinophilic myocarditis characterized by eosinophilic infiltration. LE is a rare underdiagnosed disease and associated with high morbidity and mortality. Case presentation We report a case of a 46-year-old man suffering from LE associated with thromboembolic events without peripheral eosinophilia. The patient presented with typical clinical signs of acute onset of limb ischaemia, predominantly on the right limb, indicating immediate iliacal thrombectomy and due to a severe compartment syndrome additional fasciotomy. Total occlusion also of left popliteal artery suggesting an impaired chronic and aggravated impaired perfusion indicated also urgent left sided revascularization. Subsequent echocardiography revealed severe left ventricular dysfunction with a striking amount of spontaneous echo-contrast, noticeable in the left ventricular cavity. Furthermore the initial CT scan demonstrated asymptomatic left kidney- and brain infarctions. Diagnostic workup including endomyocardial biopsy (EMB) of the left ventricle, uncovered an underlying LE without peripheral eosinophilia. Conclusions This case demonstrates and highlights the findings, treatment and outcome of a patient with LE and associated thrombo-embolic events without peripheral eosinophilia and emphazises the importance of awareness for LE in patients presenting with an acute cardiac decompensation and thrombo-embolic events. EMB should be performed early in unstable patients unsuitable for cardiovascular magnetic resonance imaging.

ObjectivesIn hypertension, low myocardial energetic efficiency (MEEi) has been documented as an integrated marker of metabolic and left ventricular (LV) myocardial dysfunction. We tested the predictive performance of MEEi in initially asymptomatic aortic stenosis (AS) patients free from diabetes and known cardiovascular disease.MethodsData from 1703 patients with mostly moderate AS enrolled in the Simvastatin and Ezetimibe in Aortic Stenosis study followed for 4.3 years was used. MEE was calculated from Doppler stroke volume/([heart rate/60]) and indexed to LV mass (MEEi). The threshold value for MEEi associated with increased mortality was identified in generalised additive model with smoothing splines. Covariables of MEEi were identified in logistic regression analysis. Outcome was assessed in Cox regression analysis and reported as HR and 95% CI.ResultsMEEi <0.34 mL/s per gram was associated with increased cardiovascular mortality (n=80) (HR 2.53 (95% CI 1.50 to 4.28)) and all-cause mortality (n=155) (HR 1.74 (95% CI 1.20 to 2.52)) (both p<0.01). The association was independent of confounders of low MEEI (<0.34 mL/s per gram) identified in multivariable logistic regression analysis, including more severe AS, higher body mass index, lower LV midwall shortening and ejection fraction and presence of hypertension. Comparison of the Cox models with and without MEEi among the covariables demonstrated that MEEi significantly improved the prognostic yield (both p<0.01).ConclusionsIn patients with initially asymptomatic AS, low MEEi was associated with clustering of cardiometabolic risk factors, lower LV myocardial function and subsequent increased mortality during 4.3 years follow-up, independent of known prognosticators.Trial registration numberNCT00092677.

BACKGROUND Acceleration time (AT)/ejection time (ET) ratio is a marker of aortic valve stenosis (AS) severity and predicts outcome in moderate-severe AS. METHODS We explored the association of increased AT/ET ratio on prognosis in 1530 asymptomatic patients with presumably mild-moderate AS, normal ejection fraction, and without known diabetes or cardiovascular disease. Patients were part of the SEAS study (Simvastatin Ezetimibe Aortic Stenosis). Patients were grouped according to the optimal AT/ET ratio threshold to predict cardiovascular death and heart failure hospitalization. Low-gradient severe AS was identified as combined valve area ≤1.0 cm2 and mean gradient <40 mm Hg. Outcome was assessed in Cox regression analyses, and results are reported as hazard ratio and 95% CI. RESULTS Higher AT/ET ratio was significantly associated with lower systolic blood pressure, lower left ventricular ejection fraction, lower stress-corrected midwall shortening, low flow, and with higher left ventricular mass and higher peak aortic jet velocity. AT/ET ratio ≥0.32 provided the optimal cutoff for predicting incident cardiovascular death and heart failure hospitalization in the total study sample. In patients with low-gradient severe AS, this threshold was >0.32. AT/ET ratio ≥0.32 had a 79% higher risk of cardiovascular death and heart failure hospitalization (hazard ratio, 1.79 [95% CI, 1.20-2.68]). In patients with low-gradient severe AS, AT/ET ratio >0.32 was associated with a 2-fold higher risk of cardiovascular death and heart failure hospitalization (hazard ratio, 2.15 [95% CI, 1.22-3.77]). CONCLUSIONS In asymptomatic nonsevere AS and low-gradient severe AS, higher AT/ET ratio was associated with increased cardiovascular morbidity and mortality. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00092677.

Background Eosinophilic myocarditis (EM) is a rare form of myocarditis. Clinical presentation is various, includes cardiogenic shock and can often be fatal. Diagnosis is based on myocardial eosinophilic infiltration in endomyocardial biopsy. Mechanical circulatory support (MCS) is often required in patients suffering from severe cardiogenic shock. Among the available MCS options the “ECMELLA” concept, a combination of left ventricular venting by Impella® device and extracorporeal life support (ECLS) is possibly able to provide the necessary time frame for diagnostics and initiation of anti-inflammatory medication in patients with fulminant myocarditis. Case presentation We report a case of a 38‐year‐old woman who was presented to us in severe cardiogenic shock, quickly requiring hemodynamic support by an Impella CP® device. Further dramatic hemodynamic deterioration accompanied by multi-organ dysfunction required escalation of MCS via ECLS as veno‐arterial extracorporeal membrane oxygenation (VA-ECMO). After histopathological diagnosis of EM, our patient was put on immunosuppressive therapy with prednisolone. Recovery of both right and left ventricular function allowed explanation of VA-ECMO on day 4 and further hemodynamic improvement allowed removal of the Impella® device on day 9. The patient was discharged after 7 weeks with fully restored cardiac function and in a good neurological state. Conclusions In severe cardiac shock due to fulminant EM the ECMELLA concept as bridge-to-recovery seems to be a valid option to provide the required time for diagnostics and specific therapy.

Ein 54-jähriger Lkw-Fahrer wurde mittels Rettungshubschrauber über die Notaufnahme unserer Klinik vorstellig, nachdem er mit einer Glasgow Coma Scale von 8 Punkten im Führerhäuschen seines Lkw aufgefunden wurde. Bei Eintreffen des Notarztes war der Patient hämodynamisch stabil, auffällig war eine Hemiparese links und Blickwendung nach rechts, keine Sprachproduktionund es erfolgte eine Schutzintubation. Anamnestischwaren bis auf einmedikamentös behandelter arteriellerHypertonus sowie Nikotinabusus keine Vorerkrankungen bekannt.

Abstract Introduction Acceleration/ejection time (AT/ET) ratio is a marker of aortic stenosis (AS) severity, and a predictor of outcome in severe AS. The importance of ejection dynamics in mild and moderate AS has been less investigated. Purpose To investigate the impact of increased AT/ET ratio on prognosis in patients with mild-moderate AS. Methods Data from 1635 patients with asymptomatic mild-moderate AS with preserved ejection fraction enrolled in the Simvastatin and Ezetimibe in Aortic Stenosis study was analysed. Covariates of higher AT/ET ratio was identified in linear regression analysis. Outcome was assessed in Cox regression analyses and reported as hazard ratio (HR) and 95% confidence interval (CI) per 1 standard deviation (SD) higher AT/ET ratio. Median follow-up time was 4 years. Results The total study population included 38% female, mean age 67 years and average peak aortic jet velocity was 3.02 m/s. Higher AT/ET ratio was significantly associated with lower ejection fraction, higher LV mass, higher aortic jet velocity, lower systolic blood pressure, low stroke volume index and lower stress-corrected midwall shortening (all p<0.05). In Cox regression analyses, adjusting for these confounders including age and gender, 1 SD higher AT/ET ratio predicted a 29% increase in hazard for major cardiovascular events, 25% for cardiovascular death and hospitalization for heart failure and 23% increase in hazards for all-cause mortality (Table). Conclusion In asymptomatic mild-moderate AS patients free from diabetes and known cardiovascular disease, higher AT/ET ratio was associated with increased risk for major cardiovascular events, cardiovascular death and hospitalization for heart failure and all-cause mortality independent of traditional risk markers. Funding Acknowledgement Type of funding source: None

In hypertension, indexes of midwall left ventricular (LV) function may identify patients at higher cardiovascular (CV) risk independent of normal LV ejection fraction (EF). We analyzed the association of baseline and new‐onset LV midwall dysfunction with CV outcome in a large population of patients with asymptomatic aortic stenosis (AS).

Anorexia nervosa is a potentially life-threatening eating disorder, characterized by an abnormally low body weight. This case report illustrates a 22-year old female with cardiac arrest due to a refeeding syndrome in a patient with anorexia nervosa. It features the successful use of extracorporeal cardiopulmonary resuscitation in a case of severe left ventricular dysfunction resulting in a favorable outcome. Conclusion. We present the first case of a cardiac arrest due to a refeeding syndrome in anorexia nervosa featuring the successful use of an extracorporeal cardiopulmonary resuscitation approach as a bridge to full recovery.

Objective Lower systemic arterial compliance (SAC) is associated with increased cardiovascular morbidity and mortality in hypertension, but this has not been assessed in a prospective study in aortic valve stenosis (AS). Methods Data from 1641 patients (38% women) with initially asymptomatic mild-moderate AS enrolled in the Simvastatin and Ezetimibe in Aortic Stenosis study was used. Median follow-up was 4.3 years. SAC was assessed from Doppler stroke volume index to central pulse pressure ratio and considered low if <= 0.64 mL/m(2), corresponding to the lower tertile in the population. The association of SAC with outcome was assessed in Cox regression analysis and reported as HR and 95% CI. Results Low SAC at baseline was characterised by older age, female sex, hypertension, obesity, presence of a small aortic root, lower mean aortic gradient and more severe AS by effective aortic valve area (all p<0.01). In Cox regression analysis adjusting for factors, low SAC was associated with higher HRs for cardiovascular death (HR 2.13(95% CI 1.34 to 3.40) and all-cause mortality (HR 1.71(95% CI 1.23 to 2.38)), both p=0.001). The results did not change when systolic or diastolic blood pressure, other measures of AS severity or presence of discordantly graded AS were included in subsequent models. Presence of low SAC did not improve mortality prediction in reclassification analysis. Conclusions In patients with AS without diabetes and known cardiovascular disease, but a high prevalence of hypertension, low SAC was associated with higher cardiovascular and all-cause mortality independent of well-known prognosticators.

ObjectiveWhether increased myocardial oxygen demand could help explain the association of left ventricular (LV) hypertrophy with higher adverse event rate in patients with aortic valve stenosis (AS) is unknown.MethodsData from 1522 patients with asymptomatic mostly moderate AS participating in the Simvastatin-Ezetimibe in AS study followed for a median of 4.3 years was used. High LV mass–wall stress–heart rate product was identified as >upper 95% CI limit in normal subjects. The association of higher LV mass–wall stress–heart rate product with major cardiovascular (CV) events, combined CV death and hospitalised heart failure and all-cause mortality was tested in Cox regression analyses, and reported as HR and 95% CI.ResultsHigh LV mass–wall stress–heart rate product was found in 19% at baseline, and associated with male sex, higher body mass index, hypertension, LV hypertrophy, more severe AS and lower LV ejection fraction (all p<0.01). Adjusting for these confounders in time-varying Cox regression analysis, 1 SD higher LV mass–wall stress–heart rate product was associated with higher HR of major CV events (HR 1.16(95% CI 1.06 to 1.29)), combined CV death and hospitalised heart failure (HR 1.29(95% CI 1.09 to 1.54)) and all-cause mortality (HR 1.34(95% CI 1.13 to 1.58), all p<0.01).ConclusionIn patients with initially mild–moderate AS, higher LV mass–wall stress–heart rate product was associated with higher mortality and heart failure hospitalisation. Our results suggest that higher myocardial oxygen demand is contributing to the higher adverse event rate reported in AS patients with LV hypertrophy.Trial registration numberNCT000092677;Post-results.