Outcomes of Redo Transcatheter Aortic Valve Replacement for the Treatment of Postprocedural and Late Occurrence of Paravalvular Regurgitation and Transcatheter Valve Failure.

BACKGROUND: Transcatheter aortic valves can degenerate in a manner similar to surgical bioprostheses. METHODS AND RESULTS: Clinical and echocardiographic outcomes of patients who underwent redo transcatheter aortic valve replacement (TAVR) procedures >2 weeks post procedure were collected from 14 centers. Among 13 876 patients, 50 (0.4%) underwent redo TAVR procedure at participating centers. Indications for redo TAVR were moderate-severe prosthetic aortic valve stenosis (n=10, 21.7%), moderate-severe central prosthetic aortic valve regurgitation (n=13, 28.3%), and moderate-severe paraprosthetic aortic valve regurgitation (n=25, 50.0%). The index TAVR was most commonly a Medtronic CoreValve (N=38, 76.0%), followed by Edwards SAPIEN-type valves (n=12, 24.0%) and Portico (n=1, 2.0%). The redo TAVR device was most commonly a CoreValve/Evolut R (n=29, 58.0%), followed by a SAPIEN-type valve (n=20,40.0%) or a Boston Lotus valve (n=1, 2.0%). In 40 patients (80.0%), redo TAVR was performed using the identical device type or that of the succeeding generation. Valve performance was uniformly good after redo TAVR (mean transvalvular gradient post redo TAVR: 12.5±6.1 mm Hg). At hospital discharge, all patients remained alive, with 1 nondisabling stroke (2.0%) and 1 life-threatening bleed (2.0%). Permanent pacemaker implantation was required in 3 out of 35 patients without a prior pacemaker (8.6%). Late survival was 85.1% at a median follow-up of 1589 days (range: 31-3775) after index TAVR and 635 days (range: 8-2460) after redo TAVR. CONCLUSIONS: Redo TAVR for the treatment of postprocedural and late occurrence of paravalvular regurgitation and transcatheter aortic valve prosthesis failure seems to be safe, and it is associated with favorable acute and midterm clinical and echocardiographic outcomes.

Clinical and psychological telemonitoring and telecare of high risk heart failure patients.

We conducted a trial of telemonitoring and telecare for patients with chronic heart failure leaving hospital after being treated for clinical instability. Eighty patients were randomized before hospital discharge to a usual care group (n=40: follow-up at the outpatient clinic) or to an integrated management group (n=40: patients learned to use a handheld PDA and kept in touch daily with the monitoring centre). At enrolment, the groups were similar for all clinical variables. At one-year follow-up, integrated management patients showed better adherence, reduced anxiety and depression, and lower NYHA class and plasma levels of BNP with respect to the usual care patients (e.g. NYHA class 2.1 vs 2.4, P<0.02). Mortality and hospital re-admissions for congestive heart failure were also reduced in integrated management patients (P<0.05). Integrated management was more expensive than usual care, although the cost of adverse events was 42% lower. In heart failure patients at high risk of relapse, the regular acquisition of simple clinical information and the possibility for the patient to contact the clinical staff improved drug titration, produced better psychological status and quality of life, and reduced hospitalizations for heart failure.

Prognostic value of noninvasive hemodynamic evaluation of the acute effect of levosimendan in advanced heart failure.

AIMS: Optimization of inotropic treatment in worsening heart failure sometimes requires invasive hemodynamic assessment in selected patients. Impedance cardiography (ICG) may be useful for a noninvasive hemodynamic evaluation. METHODS: ICG was performed in 40 patients (69 ± 8 years; left ventricular ejection fraction 27.5 ± 5.6%; New York Heart Association 3.18 ± 0.34; Interagency Registry for Mechanically Assisted Circulatory Support 5.48 ± 0.96, before and after infusion of Levosimendan (0.1­0.2 µg/kg per min for up to 24 h). Echocardiogram, ICG [measuring cardiac index (CI), total peripheral resistances (TPRs) and thoracic fluid content (TFC)] and plasma levels of brain natriuretic peptide (BNP) were obtained; in nine patients, right heart catheterization was also carried out. RESULTS: When right catheterization and ICG were performed simultaneously, a significant relationship was observed between values of CI and TPR, and between TFC and pulmonary wedge pressure. ICG detected the Levosimendan-induced recovery of the hemodynamic status, associated with improved systolic and diastolic function and reduction in BNP levels. One-year mortality was 4.4%. At multivariate analysis, independent predictors of mortality were: no improvement in the severity of mitral regurgitation, a persistent restrictive filling pattern (E/E' > 15), a reduction of BNP levels below 30% and a change below 10% in CI, TPR and TFC. When combined, absence of hemodynamic improvement at ICG could predict 1-year mortality with better sensitivity (86%) and specificity (85%) than the combination of echocardiographic and BNP criteria only (sensitivity 80% and specificity 36%). CONCLUSION: Noninvasive hemodynamic evaluation of heart failure patients during infusion of inodilator drugs is reliable and may help in their prognostic stratification.

Transthoracic bioimpedance and brain natriuretic peptide assessment for prognostic stratification of outpatients with chronic systolic heart failure.

BACKGROUND: In patients with chronic heart failure, physical evaluation and clinical judgment may be inadequate for prognostic stratification. HYPOTHESIS: Information obtained with simple bedside tests would be helpful in patient management. METHODS: We report on 142 outpatients with systolic heart failure seen at our heart failure unit from 2007 to 2010 (ages 69.4 ± 8.9 years; ejection fraction [EF] 30.6 ± 6.1%; 43% with implanted defibrillators and/or resynchronization devices). At their first visit, we assessed levels of brain natriuretic peptide (BNP) (pg/mL), evaluated transthoracic conductance (TFC) (1/kΩ) by transthoracic bioimpedance, and performed echocardiography. RESULTS: Four-year mortality was 21.2%. At multivariate analysis, surviving and deceased subjects did not differ regarding New York Heart Association, age, gender, heart failure etiology, or EF at index visit. Patients who died had higher BNP and TFC (BNP = 884 ± 119 pg/mL vs 334 ± 110 pg/mL; TFC = 50 ± 8/kΩ vs 37 ± 7/kΩ, both P < 0.001]. Patients with BNP < 450 pg/mL and TFC < 40/kΩ had a 2.1% 4-year mortality, compared to 46.5% mortality of patients having BNP ≥ 450 pg/mL and TFC ≥ 40/kΩ. BNP ≥ 450 pg/mL and TFC ≥ 40/kΩ showed high sensitivity (91%) and specificity (88%)in identifying patients who died at follow-up. CONCLUSIONS: The combined use of BNP and impedance cardiography during the first assessment of a patient in a heart failure unit identified those carrying a worse medium-term prognosis. This approach could help the subsequent management of patients, allowing better clinical and therapeutic strategies.

Blood pressure control and treatment adherence in hypertensive patients with metabolic syndrome: protocol of a randomized controlled study based on home blood pressure telemonitoring vs. conventional management and assessment of psychological determinants of adherence (TELEBPMET Study).

BACKGROUND: Inadequate blood pressure control and poor adherence to treatment remain among the major limitations in the management of hypertensive patients, particularly of those at high risk of cardiovascular events. Preliminary evidence suggests that home blood pressure telemonitoring (HBPT) might help increasing the chance of achieving blood pressure targets and improve patient's therapeutic adherence. However, all these potential advantages of HBPT have not yet been fully investigated. METHODS/DESIGN: The purpose of this open label, parallel group, randomized, controlled study is to assess whether, in patients with high cardiovascular risk (treated or untreated essential arterial hypertension--both in the office and in ambulatory conditions over 24 h--and metabolic syndrome), long-term (48 weeks) blood pressure control is more effective when based on HBPT and on the feedback to patients by their doctor between visits, or when based exclusively on blood pressure determination during quarterly office visits (conventional management (CM)). A total of 252 patients will be enrolled and randomized to usual care (n = 84) or HBPT (n = 168). The primary study endpoint will be the rate of subjects achieving normal daytime ambulatory blood pressure targets (< 135/85 mmHg) 24 weeks and 48 weeks after randomization. In addition, the study will assess the psychological determinants of adherence and persistence to drug therapy, through specific psychological tests administered during the course of the study. Other secondary study endpoints will be related to the impact of HBPT on additional clinical and economic outcomes (number of additional medical visits, direct costs of patient management, number of antihypertensive drugs prescribed, level of cardiovascular risk, degree of target organ damage and rate of cardiovascular events, regression of the metabolic syndrome). DISCUSSION: The TELEBPMET Study will show whether HBPT is effective in improving blood pressure control and related medical and economic outcomes in hypertensive patients with metabolic syndrome. It will also provide a comprehensive understanding of the psychological determinants of medication adherence and blood pressure control of these patients. TRIAL REGISTRATION: Clinical Trials.gov: NCT01541566.

Intermittent levosimendan infusions in advanced heart failure: favourable effects on left ventricular function, neurohormonal balance, and one-year survival.

The role of repeated infusions of Levosimendan (LEVO) in patients with chronic advanced heart failure is still unclear. Thirty-three patients with chronic heart failure presenting clinical deterioration were randomized 2:1 to receive monthly infusions of LEVO (n = 22) or Furosemide (Controls, n = 11). At the first drug's administration, noninvasive hemodynamic evaluation was performed; before and after each infusion, we assessed NYHA class, systolic and diastolic function, functional mitral regurgitation, and brain natriuretic peptide (BNP) levels. Noninvasive hemodynamic in the LEVO group showed vasodilation and decrease in thoracic conductance (index of pulmonary congestion), whereas in Controls, only a reduced thoracic conductance was observed. In the LEVO group, systolic and diastolic function, ventricular volumes, severity of mitral regurgitation, and BNP levels improved over time from baseline and persisted 4 weeks after the last infusion (P < 0.01). In Controls, no change developed over time in cardiac function and BNP levels. In LEVO-treated patients, 1-year mortality tended to be lower than in those treated with Furosemide. In conclusion, serial LEVO infusions in advanced heart failure improved ventricular performance and favorably modulated neurohormonal activation. Multicenter randomized studies are warranted to test the effect of LEVO on long-term outcome.

[What underlies NYHA class in elderly patients with heart failure? Role of diastolic dysfunction, functional mitral regurgitation and abnormal ventilation during exercise]. / Determinanti della classe NYHA nel paziente anziano con scompenso cardiaco: ruolo della disfunzione diastolica, dell'insufficienza mitralica funzionale e dell'alterata ventilazione durante esercizio.

BACKGROUND: Color-Doppler ecocardiography and cardiopulmonary stress test are pivotal in the evaluation of patients with heart failure. Besides determining systolic function through left ventricular ejection fraction (EF), color-Doppler ecocardiography evaluates the presence and degree of functional mitral regurgitation and the severity of diastolic dysfunction. Moreover, in addition to the aerobic capacity indicated by peak O2 consumption, other parameters of cardiopulmonary stress have proven useful for diagnostic purposes, such as the peak VE/VCO2 ratio or ventilatory efficiency. Since in elderly patients with heart failure the functional impairment often is a combination of the effects of aging with those of disease, the relationship between symptoms, i.e. the NYHA class, ventricular pump function and aerobic performance is sometimes difficult to estabilish. MATERIALS AND METHODS: In 60 elderly with systolic heart failure (75 +/- 3 years, EF 30 +/- 6%), we correlated symptoms (i.e. NYHA class) with [1] degree of functional mitral regurgitation (FMR) determined by color-Doppler echocardiography; [2] degree of left ventricular diastolic dysfunction, measured by Doppler analysis of transmitralic and pulmonary veins flow; [3] VO2 and VE/VCO2 at peak exercise at cardiopulmonary test. RESULTS: In all patients, NYHA class was only weakly related with EF and peak VO2, with wide overlap of individual values among patients with different NYHA class. Instead, we observed a tight relationship between NYHA class, FMR degree, and severity of diastolic dysfunction and VE/VCO2 ratio at peak exercise (p<0.001), with a more evident partition among patients in different NYHA classes. CONCLUSIONS: In elderly heart failure patients, the reduced effort tolerance expressed by the NYHA classification is only weakly associated with reduced aerobic capacity and pump function, but rather is related with the presence of mitral regurgitation, left ventricular diastolic dysfunction, and a poor ventilatory efficiency during exercise.

[Disease management for heart failure patients: role of wireless technologies for telemedicine. The ICAROS project]. / Continuità assistenziale nei pazienti con scompenso cardiaco: ruolo delle tecnologie wireless per la telemedicina. II progetto ICAROS.

Healthcare costs for heart failure are increasing. The need for a better care, however, has to be matched with a policy of cost containment. A way to improve the cost-effectiveness of heart failure care is the disease management approach, in which therapy, education and follow-up are tailored for each patient by a multidisciplinary team. Such a complex intervention can be facilitated by the use of telemedicine, which allows the remote control of considerable amounts of clinical data. In Italy, a few studies with telemedicine have been reported. A recent development in this field is represented by the ICAROS project (Integrated Care vs Conventional Intervention in Cardiac Failure Patients: Randomized Open Label Study), whose aim is to improve the clinical and psychological care of heart failure patients employing advanced wireless telecommunication technology. So far, we randomized 60 patients: 30 in usual ambulatory care, 30 in an intensive treatment group. The latter patients were instructed to use a portable computer to get in touch daily with the heart failure clinic and receive feedback instruction for the management of drug therapy and daily problems. At the first year of follow-up, the treatment group showed good compliance to drug prescriptions, and could easily handle the portable computer. The preliminary results of this ongoing study support the feasibility and appropriateness of new technologies for the management of heart failure, even in elderly patients in whom a limited expertise with these appliances could have been anticipated.