Quantifying Benefit-Risk Preferences for Heart Failure Devices: A Stated-Preference Study

Background: Regulatory and clinical decisions involving health technologies require judgements about relative importance of their expected benefits and risks. We sought to quantify heart-failure patients’ acceptance of therapeutic risks in exchange for improved effectiveness with implantable devices. Methods: Individuals with heart failure recruited from a national web panel or academic medical center completed a web-based discrete-choice experiment survey in which they were randomized to one of 40 blocks of 8 experimentally controlled choice questions comprised of 2 device scenarios and a no-device scenario. Device scenarios offered an additional year of physical functioning equivalent to New York Heart Association class III or a year with improved (ie, class II) symptoms, or both, with 30-day mortality risks ranging from 0% to 15%, in-hospital complication risks ranging from 0% to 40%, and a remote adjustment device feature. Logit-based regression models fit participants’ choices as a function of health outcomes, risks and remote adjustment. Results: Latent-class analysis of 613 participants (mean age, 65; 49% female) revealed that two-thirds were best represented by a pro-device, more risk-tolerant class, accepting up to 9% (95% CI, 7%–11%) absolute risk of device-associated mortality for a one-year gain in improved functioning (New York Heart Association class II). Approximately 20% were best represented by a less risk-tolerant class, accepting a maximum device-associated mortality risk of 3% (95% CI, 1%–4%) for the same benefit. The remaining class had strong antidevice preferences, thus maximum-acceptable risk was not calculated. Conclusions: Quantitative evidence on benefit-risk tradeoffs for implantable heart-failure device profiles may facilitate incorporating patients’ views during product development, regulatory decision-making, and clinical practice.

Long-Term Survival With Tafamidis in Patients With Transthyretin Amyloid Cardiomyopathy

Background: Tafamidis is approved in many countries for the treatment of transthyretin amyloid cardiomyopathy. This study reports data on the long-term efficacy of tafamidis from an ongoing long-term extension (LTE) to the pivotal ATTR-ACT (Tafamidis in Transthyretin Cardiomyopathy Clinical Trial). Methods: Patients with transthyretin amyloid cardiomyopathy who completed ATTR-ACT could enroll in an LTE, continuing with the same tafamidis dose or, if previously treated with placebo, randomized (2:1) to tafamidis meglumine 80 or 20 mg. All patients in the LTE transitioned to tafamidis free acid 61 mg (bioequivalent to tafamidis meglumine 80 mg) following a protocol amendment. In this interim analysis, all-cause mortality was assessed in patients treated with tafamidis meglumine 80 mg in ATTR-ACT continuing in the LTE, compared with those receiving placebo in ATTR-ACT transitioning to tafamidis in the LTE. Results: Median follow-up was 58.5 months in the continuous tafamidis group (n=176) and 57.1 months in the placebo to tafamidis group (n=177). There were 79 (44.9%) deaths with continuous tafamidis and 111 (62.7%) with placebo to tafamidis (hazard ratio, 0.59 [95% CI, 0.44–0.79]; P <0.001). Mortality was also reduced in the continuous tafamidis (versus placebo to tafamidis) subgroups of: variant transthyretin amyloidosis (0.57 [0.33–0.99]; P =0.05) and wild-type transthyretin amyloidosis (0.61 [0.43–0.87]; P =0.006); and baseline New York Heart Association class I and II (0.56 [0.38–0.82]; P =0.003) and class III (0.65 [0.41–1.01]; P =0.06). Conclusions: In the LTE, patients initially treated with tafamidis in ATTR-ACT had substantially better survival than those first treated with placebo, highlighting the importance of early diagnosis and treatment in transthyretin amyloid cardiomyopathy. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01994889 and NCT02791230.

La proteína de unión a los ácidos grasos cardíaca (HFABP) está relacionada con la gravedad de la insuficiencia cardíaca y sus biomarcadores cardíacos conocidos

Resumen Objetivos Determinar las concentraciones de proteína de unión a los ácidos grasos cardíaca (HFABP) en pacientes con insuficiencia cardíaca con fracción de eyección reducida (ICFEr) y su potencial valor pronóstico. Métodos Se determinaron las concentraciones circulantes de HFABP mediante un inmunoensayo quimioluminiscente automático en 25 voluntarios sanos y 60 pacientes con ICFEr. Resultados Los pacientes con insuficiencia cardíaca (IC) presentaron concentraciones de HFABP significativamente mayores que los voluntarios sanos. Se observó una correlación significativa entre los niveles de HFABP, la clasificación de la New York Heart Association (NYHA), y las concentraciones de los biomarcadores de disfunción y remodelado cardíaco (NT-proBNP, FGF-23 y galectina-3). Las concentraciones de HFABP también mostraron valor predictivo de muerte cardiovascular, y su combinación con NT-proBNP podría ser sinérgica a la hora de evaluar el riesgo. Conclusiónes Las concentraciones de HFABP están aumentadas en los pacientes con ICFEr, se relacionan con el riesgo cardiovascular y podrían ayudar a los especialistas en el manejo de los pacientes.

“I Can’t Go Far”: Perceptions and Experiences of Heart Failure Patients Regarding Physical Activity: A Qualitative Study Using Semistructured Face-to-Face Interviews

Background Participation in regular physical activity (RPA) is beneficial to the quality of life and life expectancy of patients with chronic heart failure (CHF). However, it is inadequate in many patients. Aims To determine the factors that influence the practice of RPA in patients with CHF managed in general practice. Method This was a qualitative study using semistructured, individual face-to-face interviews. Patients with CHF (New York Heart Association Stages 1–3) capable of participating in RPA were enrolled by their general practitioner. A longitudinal and transversal inductive thematic analysis was performed by two researchers. Results Five themes emerged from the 19 interviews that were conducted. Poor knowledge of the disease and the benefits of participating in RPA, as well as the lack of motivation or enjoyment, in particular due to the absence of previous participation, were considered significant obstacles. Fear associated with CHF or other comorbidities was also an obstacle. Attendance at a rehabilitation center, family and social circles, and having a pet all appeared to be beneficial. Family and friends were important for motivating the patient to participate in an activity but could also be an obstacle when they were overprotective. Conclusion This study helps highlight the difficulties for patients with CHF associated with participation in RPA. Despite the obstacles, there are enabling factors on which the general practitioner may rely to motivate their patients.

Severe mitral regurgitation from Libman–Sacks endocarditis treated with MitraClip: a case report

Background Systemic lupus erythematosus (SLE) valvulopathy can manifest as a spectrum of pathologies and treatment of severe valvular dysfunction thus far has been surgical. However, surgery in patients with SLE is frequently associated with high morbidity and mortality due to the presence of significant co-morbidities. Case summary We report the case of a 41-year-old woman with SLE and anti-phospholipid syndrome with extensive co-morbidities including lupus nephritis, pancytopaenia, cerebrovascular accident, and severe airway obstruction from ipsilateral lung collapse and bronchiectasis. She had severe mitral regurgitation (MR) from Libman–Sacks endocarditis and in recent months developed heart failure with progressive exertional dyspnoea from New York Heart Association (NYHA) functional Class from New York Heart Association (NYHA) functional class II to III. In addition, there was progressive left ventricular dilatation and reduction in left ventricular ejection fraction. In view of the high surgical risk, she underwent transcatheter edge-to-edge repair (TEER) of the mitral valve with the MitraClip system. At 1-month follow-up, she was back to NYHA functional Class II with mild MR. Discussion Our case demonstrates that in select patient with suitable anatomy, TEER is a potential treatment option for severe MR from SLE valvulopathy.

Initial Experience With the PASCAL Ace Implant System for Treatment of Severe Tricuspid Regurgitation

Background: Percutaneous tricuspid valve leaflet repair is an emerging treatment option for severe tricuspid regurgitation (TR). Recent studies demonstrated the usefulness and feasibility of the lately introduced TriClip and PASCAL Transcatheter Valve Repair System. However, initial experiences regarding safety and efficacy of the novel transcatheter PASCAL Ace implant system have not yet been reported. Methods: Sixteen patients with severe, massive, or torrential TR underwent tricuspid leaflet repair using the PASCAL Ace implant at our cardiology department. All patients suffered from symptomatic right-sided heart failure with New York Heart Association functional class III or IV. Clinical, laboratory, echocardiographic, and procedural data were assessed. The primary efficiency end point was postprocedural reduction in TR of at least 1 grade. Secondary end points were feasibility, safety, clinical outcome, and improvement of structural and functional right heart parameters obtained by echocardiography. Results: Eleven procedures (69%) resulted in successful reduction of TR. In 4 patients, PASCAL Ace implantation was not successful and one patient did not achieve TR reduction despite PASCAL Ace implantation. One major bleeding related to the intervention occurred. Eight patients (73%) with successful TR reduction reported a significant improvement of New York Heart Association functional class 4 weeks after implantation ( P =0.008). A significant reduction in right atrial volume from 84±41 mL/m 2 to 69±36 mL/m 2 ( P =0.004) and right ventricular end-diastolic diameter from 50±7 mm to 47±8 mm ( P =0.013) was observed; however, we did not see an improvement in right ventricular function directly after implantation. Conclusions: Tricuspid valve leaflet repair using the transcatheter PASCAL Ace implant system has the potential to improve clinical status and right heart reverse remodeling in patients with severe TR.

Endovascular closure of MINOCA-caused ventricular septal defect (VSD)

Myocardial infarction with non-obstructive coronary arteries (MINOCA) is a rare form of acute myocardial infarction and it is an even rarer cause of ventricular septal defect (VSD). We present a case of successful endovascular closure of post-MINOCA VSD with the use of an atrial septal defect (ASD) occluder. The patient improved from intra-aortic balloon pump dependent to New York Heart Association (NYHA) I in a matter of days. 18-month follow-up period is event free and symptom free.

The effect of foot massage on dyspnea ın heart faılure: Case report

Dyspnea is one of the reasons why many heart failure patients present to the emergency department. A 75 year-old female presented to a cardiologist with prominent dyspnea and orthopnea. Her heart failure was diagnosed by doctors as New York Heart Association (NYHA) Class III. Progressive increase in episodic shortness of breath forthe past 3 weeks. The patient had been in her normal state of health until 3 weeks ago that she had difficulty catching her breath while walking.The patient got 7 points from the first Borg Dyspnea Scale. The study is a case-report study. Personal Data Form (PDF), Borg Clinical Rating for Dyspnea (Borg CR-10) was evaluated by researcher. Classic foot massage was applied to each foot for a total of 30 minutes, up to 15 minutes, once a day for seven days. Dyspnea was measured after the massage following 10 min of resting. Foot massage was applied by the researcher. Distribution of dyspnea level first and seventh is given in Table 1. Dyspnea level of the patient intervention foot massage decreased to 5.00 from 7.00 at the end of seventh session. Foot massage which is an easy and safe method may be preferably used as a supportive treatment for elevated dyspnea. However, more studies are needed to examine the effect of foot massage on dyspnea level in heart failure patients.

Transcatheter tricuspid valve repair: early experience in the Netherlands

Background Symptomatic tricuspid regurgitation (TR) is increasingly prevalent and impairs quality of life and survival, despite medical treatment. Transcatheter tricuspid valve repair (TTVR) has recently become available as a treatment option for patients not eligible for tricuspid valve surgery. In this study we describe the early experience with TTVR in the Netherlands. Methods All consecutive patients scheduled for TTVR in two tertiary hospitals were included in the current study. Patients were symptomatic and had severe functional TR. TTVR was performed either with the MitraClip (off-label use) or dedicated TriClip delivery system and device. Procedural success was defined as achievement of clip implantation, TR reduction ≥ 1 grade and no need for re-do surgical or transcatheter intervention. Clinical improvement was evaluated after 4 weeks. Results Twenty-one patients (median age 78 years, 33% male, 95% New York Heart Association class ≥ 3, 100% history of atrial fibrillation) underwent TTVR. Procedural success was achieved in 16 patients, of whom 15 reported symptomatic improvement (New York Heart Association class 1 or 2). There was no in-hospital mortality and no major complications occurred. Baseline glomerular filtration rate and TR coaptation gap size were associated with procedural success. Conclusion The current study showed that TTVR seems a promising treatment option for patients with severe functional TR deemed high risk for surgery. Successful TR reduction is most likely in patients with limited coaptation gap size and strongly determines clinical benefit. Adequate patient selection and timing of treatment seem essential for an optimal patient outcome.