The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis.

OBJECTIVES: Transcatheter aortic valve replacement (TAVR) is an established therapy for patients with aortic stenosis (AS) at high surgical risk. The JenaValve™ is a second-generation, self-expanding transcatheter heart valve (THV), implanted through transapical access (TA). During stent deployment, a specific 'clipping-mechanism' engages native aortic valve cusps for fixation. We present 1-year outcomes of the JUPITER registry, a post-market registry of the JenaValve for TA-TAVR. METHODS: The JUPITER registry is a prospective, multicentre, uncontrolled and observational European study to evaluate the long-term safety and effectiveness of the Conformité Européenne-marked JenaValve THV. A total of 180 patients with AS were enrolled between 2012 and 2014. End-points were adjudicated in accordance with the valve academic research consortium document no. 1 definitions. RESULTS: The mean age was 80.4 ± 5.9 years and the mean logistic European system for cardiac operative risk evaluation I 21.2 ± 14.7%. The procedure was successful in 95.0% (171/180), implantation of a second THV (valve-in-valve) was performed in 2.2% (4/180) and conversion to surgical aortic valve replacement (SAVR) was necessary in 2.8% (5/180). No annular rupture or coronary ostia obstruction occurred. Two patients required SAVR after the day of index procedure (1.1%). All-cause mortality at 30 days was 11.1% (20/180), being cardiovascular in 7.2% (13/180). A major stroke occurred in 1.1% (2/180) at 30 days, no additional major strokes were observed during 1 year. All-cause mortality after 30 days was 13.1% (21/160) and combined efficacy at 1 year was 80.8% (122/151). At 1-year follow-up, no patient presented with more than moderate paravalvular leakage, while 2 patients (3.2%) showed moderate, 12 (19.0%) mild and 49 (82.4%) trace/none paravalvular regurgitation. CONCLUSIONS: In a high-risk cohort of patients undergoing TA-TAVR for AS, the use of the JenaValve THV is safe and effective. In patients at higher risk for coronary ostia obstruction, annular rupture or with limited aortic valve calcification, the JenaValve might be preferable for implantation due to its clipping-mechanism engaging native aortic valve cusps for fixation with reduced radial forces of the self-expanding stent.

Long-term follow-up and quality of life after closure of ventricular septal defect in adults.

OBJECTIVE: To study patients who underwent surgical closure of a congenital ventricular septal defect (VSD) and presenting at adult age. METHODS AND RESULTS: A retrospective study was carried out of 28 patients (15 male) operated upon between 1980 and 2004. Patients were investigated by echocardiography, ECG and assessed for quality of life by a questionnaire. The indication for surgery was volume overload in 11 patients, endocarditis in 8, aortic valve regurgitation in 8 and the combination of a VSD with subvalvular aortic stenosis in 1. Follow-up was complete with a mean duration of follow-up of 13 years. There was no early or late mortality. One patient was reoperated for recurrent VSD. Twenty-five patients underwent echocardiography, which revealed a trivial residual VSD in two and mild aortic regurgitation in 10 (40%) patients. One patient was in atrial fibrillation. Health related quality of life in the dimensions cognitive functioning and sleep differed significantly from that of the general population. CONCLUSION: With a relative difference in indications for closure of a VSD in adulthood, surgical closure of VSD at adult age is an adequate and safe procedure, with good results on long-term follow-up. Progression of aortic valve regurgitation is a matter of concern.

Early mobilization after aortic valve surgery.

In recent years, the focus in peri-operative care of cardiac patients has shifted from trying to create a stress-free environment to hasten the recovery of patients by providing early extubation, early mobilization, and enteral nutrition. Fast-track cardiac surgery has therefore made a paradigm shift in postoperative care. However, evidence on the safety of early postoperative mobilization in high-risk groups like aortic valve replacement surgery is lacking. Physiological evidence from controlled studies in patients undergoing aortic valve replacement (AVR) showed that heart rate increases and stroke volume falls with maintenance of cardiac output. However, the increase of 50% to 60% of oxygen consumption during mobilization is covered by increased oxygen extraction, resulting in marked mixed venous oxygen desaturation. These physiological changes during postoperative mobilization were also seen in CABG patients. The mobilization pattern was also maintained on the second day after surgery. No serious side effects were observed in the controlled trials of mobilization of AVR patients after cardiac surgery. Over a 13-year period, we have mobilized more than 1200 AVR patients. No serious situations have occurred during or in direct connection to mobilization.

Effects of exercise training after open heart surgery on quality of life and exercise tolerance in patients with mitral regurgitation or aortic regurgitation.

We conducted a questionnaire survey regarding quality of life (QOL) to evaluate the effects of exercise training on the QOL in patients with valvular heart disease after surgery. This study included 64 consecutive patients who underwent heart surgery. They were divided into two groups: exercise training could (EX(+) group, n = 31) and could not be performed (EX(-) group, n = 33) until 6 months after surgery. To evaluate the QOL and exercise tolerance, we employed "a questionnaire regarding disease and quality of life" developed for Japanese people and cardiopulmonary exercise testing. In our questionnaire survey, the improvement rating (Delta subjective/social index), which was calculated from the difference between the pre-and postoperative values, was greater in the EX(+) group than that in the EX(-) group (4.9 +/- 3.1 versus 1.1 +/- 4.0, P < 0.05). In the changes in exercise tolerance, Delta anaerobic threshold was greater in the EX(+) group (0.79 +/- 0.17 versus -0.02 +/- 0.28, P < 0.01). Moreover, there was a positive correlation between Delta subjective/social index and Delta peak VO(2) (r = 0.62, P < 0.05). We concluded that exercise training for patients after cardiac surgery improves the QOL and exercise tolerance. It is suggested that changes in subjective and social parameters contribute to an exercise training-related improvement in the QOL.

Pautas para el manejo y tratamiento del infarto agudo de miocardio y sus complicaciones / Clues to acute myocardial infartion and its complications

El presente artículo pretende establecer pautas o rutinas básicas de conducta y tratamiento de los pacientes con IAM. Pretende también establecer las indicaciones para el estudio cinecoronario-gráfico, angioplastía coronaria y cirugía de revascularización post IAM.

The effect of moderate exercise training on oxygen uptake post-aortic/mitral valve surgery.

BACKGROUND: This study determined the response of aortic and/or mitral valve replacement/reconstruction (AVR/MVR) surgery patients to a 3-month exercise rehabilitation program (ERP) of moderate intensity, frequency, and duration that commenced approximately 9 weeks post-operatively. METHODS: Based on geographic proximity and availability of transportation to attend ERP classes, 29 experimental subjects were enrolled in the ERP and 20 control subjects received standard care that did not include the ERP, but did not prohibit activity/exercise. Exercise tolerance was determined from estimated oxygen uptake (VO2) during exercise tolerance testing (GXT) before and after standard care or the ERP. RESULTS: VO2 at the maximum stage of the GXT increased significantly (P < or = 05) for the experimental (4.89 +/- 5.07 mL/kg/min) and control (5.11 +/- 4.48 mL/kg/min) groups. No significant between-group differences were noted in VO2 at the maximum stage of the exercise testing or at the target heart rate (HR). Furthermore, reported exercise levels of subjects in both groups were comparable and sufficient for training effects to occur. CONCLUSION: Alternate strategies to improve exercise tolerance such as home-based rehabilitation programs should be investigated for relatively healthy aortic and/or mitral valve surgical patients.

[Use of anaerobic threshold for determining the level of exercise capacity in rehabilitation of patients operated on for heart defects]. / Ispol'zovanie anaérobnogo poroga dlia naznacheniia treniruiushchego urovnia nagruzki pri reabilitatsii bol'nykh, operirovannykh po povodu porokov serdtsa.

An analysis of results of spiroergometry and radionuclide ventriculography in the mixed group of cardiosurgical patients allowed to reveal a reliable accretion of fraction of expulsion of the left ventricle during transition from the state of rest to work at the level of anaerobic threshold and absence of accretion of this index in further increase of exercise. The results obtained allowed to propose the use of anaerobic threshold equal to 60% of the threshold uptake of oxygen as an indicator in choosing the optimum intensity of the training exercise of patients operated on for heart diseases.

[Changes in ECG indices and hemodynamics during bicycle ergometry of patients following aortic valve prosthesis]. / Izmeneniia pokazatelei EKG i gemodinamiki vo vremia veloérgometrii u bol'nykh posle protezirovaniia aortal'nogo klapana.

Correlated electrocardiographic and hemodynamic changes have been demonstrated in 60 convalescent patients within 3 years after aortic valve replacement by means of bicycle ergometry (BEM) and simultaneous Kubicek's impedance rheoplethysmography. As electrocardiographic ischemic changes are more frequent during recovery, while their hemodynamic causes are different during and after exercise, BEM load increment should be intermittent in patients with aortic valve prosthesis. Exercise-induced increase of R voltage that was mostly combined with inadequate hemodynamic response and accompanied by ischemic ST depression may be an additional criterion of threshold stress.

[ECG and hemodynamic changes during the bicycle ergometry of patients following aortic valve prosthesis]. / Izmeneniia EKG i gemodinamiki vo vremia veloérgometrii u bol'nykh posle protezirovaniia aortal'nogo klapana.

Interrelated ECG and hemodynamic changes were revealed in an analysis of the results of a bicycle ergometry test (BET) with the recording of ECG in 12 accepted leads and simultaneous impedance rheoplethysmography after Kubichek in 60 patients during rehabilitation for 3 yrs after aortic valve replacement. Impedance-measuring investigation of hemodynamics after physical exercise provided valuable information on causes of ECG changes. More frequent development of ischemic changes during rehabilitation and a variety of hemodynamic causes of changes in physical exercise and in the period of restitution necessitated intermittent BET in patients with a prosthesis of the aortic valve. An increase in voltage of the R wave during BET was combined in most cases with other inadequate hemodynamic reactions and was accompanied by an "ischemic" decrease in ST, and could serve as an additional criterion of threshold exercise.

Vigorous physical training after aortic valve replacement: analysis of 10 patients.

Improved prosthetic aortic valves have reduced the incidence of complications to a point where it can be hypothesized that functional class I subjects after aortic valve replacement (AVR) should adapt to a vigorous training program without a significant increase of hemolytic activity or clinical signs of prosthesis malfunction. To test this hypothesis, 10 men (mean age 52 years) who had undergone AVR (7 Björk-Shiley and 3 Lillehei-Kaster) were submitted to an 8-week training program on ergometer, 3 times/week, from 60 to 80% of individual maximal heart rate. Ten other men who had undergone AVR but did not participate in the training program were control subjects. The exercise program produced significant improvements in posttraining maximum tolerated ergometer work load (210 kpm, p less than 0.001), in maximum total body oxygen consumption (5 ml/kg X min-1, p less than or equal to 0.01) and in double product at submaximal work load (-5,126, p less than or equal to 0.01). After training, hemoglobin decreased by about 1 g% (p less than or equal to 0.05) and hematocrit, reticulocyte counts and haptoglobin did not change significantly. Serum LDH and serum AST did not increase. Pre- and post-training echocardiograms did not show detectable alterations. Thus, patients with AVR who are in functional class I can adapt to a physical exercise program without significant adverse effects.

[Evaluation of patient rehabilitation effectiveness after aortic valve prosthesis based on spiroergometric study data]. / Otsenka éffektivnosti reabilitatsii bol'nykh posle protezirovaniia aortal'nogo kaplana po dannym spiroérgometricheskogo issledovaniia.

Patients after surgery introducing aortal valve prosthesis in cases of rheumatic aortal defect or defect due to bacterial endocarditis were examined using spiro- and bicycle ergometry. Two groups of patients were compared: those subjected to rehabilitation procedures and a control group undergoing no rehabilitation program. Functional results were better in post-rehabilitation patients. By the end of the rehabilitation program, the examined spiroergometric parameters were significantly closer to those of normal subjects, as compared to the controls. Spiroergometric investigation in patients with newly applied aortal valve prostheses supplements clinical data in providing a more profound functional evaluation of surgical results and rehabilitation efficiency.