Brunilda Alushi

Interventional Treatment of Severe Tricuspid Regurgitation: Early Clinical Experience in a Multicenter, Observational, First-in-Man Study

Background— Transcatheter caval valve implantation is under evaluation as a treatment option for inoperable patients with severe tricuspid regurgitation (TR). The procedure involves the catheter-based implantation of bioprosthetic valves in the inferior vena cava and superior vena cava to treat symptoms associated with TR. This study is the first to evaluate the feasibility, safety, and efficacy of this interventional concept. Methods and Results— Twenty-five patients (mean age, 73.9±7.6 years; women, 52.0%) with severe symptomatic TR despite optimal medical treatment deemed unsuitable for surgery were treated with caval valve implantation under a compassionate clinical use program. Technical feasibility defined as procedural success, hemodynamic effect defined as venous pressure reduction, and safety defined as periprocedural adverse events were evaluated, with clinical follow-up at discharge and up to 12 months. The functional impact was evaluated by assessment of New York Heart Association class at the time of hospital discharge. The total number of valves implanted in the caval position was 31. Patients were treated with single (inferior vena cava-only; n=19; 76.0%) or bicaval valve implantation (inferior vena cava+superior vena cava; n=6; 24.0%). Either balloon-expandable valves (Sapien XT/3: n=18; 72.0%) or self-expandable valves (TricValve: n=6; 24.0%; Directflow: n=1; 4.0%) were used. Procedural success was achieved in 96% (n=24). Early and late valve migration requiring surgical intervention occurred in 1 patient each. Thirty-day and in-hospital mortality were 8% (2 of 25) and 16% (4 of 25). Causes of in-hospital mortality included respiratory (n=1) or multiple organ failure (n=3) and were not linked to the procedure. Mean overall survival in the study cohort was 316±453 days (14–1540 days). Conclusions— Caval valve implantation for the treatment of severe TR and advanced right ventricular failure is associated with a high procedural success rate and seems safe and feasible in an excessive-risk cohort. The study demonstrates hemodynamic efficacy with consistent elimination of TR-associated venous backflow and initial clinical improvement. These results encourage further trials to determine which patients benefit most from this interventional approach.

Tricuspid Regurgitation – Medical Management and Evolving Interventional Concepts

Severe tricuspid regurgitation (TR) is a complex condition of the right ventricle (RV) and tricuspid valve apparatus and is frequently associated with symptomatic heart failure and a significant morbidity and mortality. In these patients, left heart pathologies lead to chronic pressure overload of the RV, eventually causing progressive RV dilatation and functional TR. Therefore, TR cannot be considered as isolated heart valve disease pathology but has to be understood and treated as one component of a complex structural RV pathology and is frequently also a marker of an advanced stage of cardiac disease. In these patients, medical therapy restricted to diuretics and heart failure medication is frequently ineffective. Also, severe TR in the setting of advanced heart failure constitutes a high risk for cardiac surgery. Neither one of these treatment options has demonstrated a beneficial effect on long-term prognosis. The recent innovations in transcatheter technology led to efforts to develop interventional approaches to severe TR. Multiple innovative treatment concepts are currently under preclinical and clinical investigation to replace or repair TV function. However, up to date none of these approaches is established and there is still a lack of clinical data to support the efficacy of transcatheter TR treatment.

Patent foramen ovale closure for patients excluded from the randomized cryptogenic stroke trials: response to letter by Zaman et al.

We very much appreciate the comments of Drs. Zaman, Patel and Mojadidi on our meta-analysis [1]. Indeed, the appropriate selection of patients with cryptogenic stroke who will benefit the most from PFO closure is a highly relevant clinical issue and the topic of an ongoing debate [2] since the publication of the recent randomized clinical trials (RCT), Patent Foramen Ovale Closure or Anticoagulants versus Antiplatelet Therapy to Prevent Stroke Recurrence (CLOSE), GORE Helex Septal Occluder/GORE CARDIOFORM Septal Occluder for PFO Closure in Stroke Patients–The GORE REDUCE Clinical Study (REDUCE) and DEFENSE-PFO [3–5]. As indicated in these trials, the exclusion of alternative etiologies of ischemic stroke in patients between 18 and 60 years of age, is the conditio sine qua non for implicating a PFO causality and supporting the benefit of PFO closure. The presence of specific anatomical features of PFO as atrial septal aneurysm (ASA) and large shunt is likely associated with an increased, device-related, benefit, but we are far from absolute certainty. Indeed, in the recent DEFENSEPFO trial, replicating the results of the CLOSE trial in a cohort with “high-risk” anatomic PFO features, no recurrent strokes in the PFO closure arm were reported, in contrast to the medical therapy arm. Notably, in REDUCE, where only 41% of patients had a large shunt, there was a clear benefit of PFO closure [77% risk reduction, hazard ratio 0.23, 95% CI (0.09, 0.60)] despite the presence of patients with PFOs with “low-risk anatomic features”. Further, in RESPECT, the superiority of closure in presence of ASA could not be demonstrated. In our metanalysis of five RCTs we found that PFO closure is beneficial beyond its anatomical features [1]. This discrepancy probably relies on the heterogeneity of shunt classification and reported outcomes for different groups of shunt degree among the trials (Fig. 1). This heterogeneity also characterized the types of devices used and medical treatment accompanying both the PFO closure and medical therapy arm and probably explains why a metanalysis of pooled data is insufficient to identify the magnitude of benefit in different subgroups. Hence, before drawing strong conclusions, patient level data are necessary to provide more robust results. In their letter, Zaman et al. suggest that patients older than 60 years of age with PFO and probably no concomitant comorbidities should have the PFO closed for secondary prevention of recurrent ischemic stroke. In this situation, we think that the treatment strategy should be patient centric and tailored to the likelihood of the causal probability of PFO. In fact, patients between 60 and 65 years of age are more likely to have concomitant low-to intermediate risk causes of stroke thereby reducing the likelihood of a PFO causality for cryptogenic stroke. Conversely, those over 65 years, more prone to concomitant venous thromboembolism and right to left shunting—probably due to increased rates of pulmonary hypertension [6] and sleep-apnea [7, 8],—have an increased likelihood of PFO related causality. Moreover, as reported in the CRYSTAL-AF study, in patients with cryptogenic stroke the burden of paroxysmal atrial fibrillation is different in different age groups [9]. In addition, we do not have RCT-based * Adnan Kastrati kastrati@dhm.mhn.de

Correction to: Transcatheter valve-in-valve implantation (VinV-TAVR) for failed surgical aortic bioprosthetic valves

Unfortunately, an error occurred in the original article.

Intimomedial Abrasion Complicating Coronary Thrombus Aspiration

A 73-year-old man referred for primary percutaneous coronary intervention (pPCI) presented with complete occlusion of the proximal left anterior descending artery (LAD) ([Online Video 1][1]). Aspiration thrombectomy was performed with an Export AP catheter (forward-facing tip, 1.09-mm inner lumen