Percutaneous Transcatheter Mitral Valve Replacement: First-in-Human Experience With a New Transseptal System.

BACKGROUND: Severe mitral regurgitation (MR) conveys significant morbidity and mortality, and surgical repair or replacement may not be a desirable option. OBJECTIVES: The purpose of this study was to evaluate the feasibility of a percutaneous transseptal transcatheter mitral valve replacement (TMVR) system. METHODS: This first-in-human study was conducted between August 2017 and August 2018. The system comprises a nitinol dock, which encircles the chordae tendineae, and a balloon-expandable transcatheter heart valve. The dock and transcatheter heart valve form an ensemble, with the native mitral valve leaflets secured in between, thereby abolishing MR. Key inclusion criteria were severe symptomatic MR and high surgical risk; exclusion criteria included left ventricular ejection fraction <30% or screening suggesting unfavorable anatomy. The primary endpoint was technical success as defined by Mitral Valve Academic Research Consortium (MVARC) criteria at completion of the index procedure. The secondary endpoint was freedom from mortality, stroke, and device dysfunction (MR grade >1, mitral gradient >6 mm Hg, left ventricular outflow tract gradient >20 mm Hg) at 30 days. RESULTS: Ten patients with severe MR of various etiologies (4 degenerative, 4 functional, and 2 mixed) were treated. The device was successfully implanted and the primary endpoint was achieved in 9 of 10 patients (90%). By transesophageal echocardiography, total MR was reduced to ≤ trivial in all implanted patients, and mean transmitral gradient was 2.3 ± 1.4 mm Hg. A pericardial effusion occurred in 1 patient: pericardiocentesis was performed, and the device was not implanted. Median length of hospital stay was 1.5 days. At 30 days, there was no stroke, myocardial infarction, rehospitalization, left ventricular outflow tract obstruction, device migration, embolization, or conversion to mitral surgery. One patient had recurrent regurgitation due to a paravalvular leak, treated with a closure device. All other treated patients had ≤1+ MR. No patients died. CONCLUSIONS: Percutaneous transvenous transseptal TMVR is feasible and safe in patients with severe MR who are at high risk for mitral valve surgery. Further evaluation is warranted.

Review of reported causes of device embolization following trans-catheter aortic valve implantation.

Transcatheter heart valve (THV) embolization is a rare but serious complication of transcatheter aortic valve implantation. Studies, including case reports, case series, and original reports published between 2002 and 2013, with regard to THV embolization were identified with a systemic electronic search using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. A total of 19 publications describing 71 patients were identified. Most patients (64%) were men, with a mean age of 80 ± 6 years and a mean logistic European System for Cardiac Operative Risk Evaluation score of 22.4 ± 9.3%. Balloon-expandable valves were used in 72% of the patients. The reported transcatheter aortic valve replacement access site was transfemoral in 80% of patients. Most cases (90%) occurred <1 hour after implantation, whereas 10% had late embolization (range 4 hours to 43 days). The most common site of embolization was the ascending aorta (38%), followed by the left ventricle (31%), descending aorta (23%), and aortic arch (8%). Open-heart surgery was required in 28% for valve retrieval and replacement. The 30-day stroke and mortality rates were 11% and 17%, respectively. Ventricular embolization and urgent conversion to open-heart surgery were significantly associated with death during hospitalization (p = 0.017 and p = 0.029, respectively). Likely causes of embolization were identified in 59 patients, with positioning error as the most commonly reported (47%), followed by pacing error (13%). In conclusion, THV embolization occurred early after transcatheter aortic valve implantation. The ascending aorta was the most common site of embolization. Higher 30-day stroke and mortality rates were associated with THV embolization compared with most published series of transcatheter aortic valve implantation outcomes.

Medium term outcomes of transapical aortic valve implantation: results from the Italian Registry of Trans-Apical Aortic Valve Implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been proposed as a therapeutic option for high-risk or inoperable patients with severe symptomatic aortic valve stenosis. The aim of this multicenter study was to assess early and medium term outcomes of transapical aortic valve implantation (TA-TAVI). METHODS: From April 2008 through June 2012, a total of 774 patients were enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Twenty-one centers were included in the I-TA registry. Outcomes were also analyzed according to the impact of the learning curve (first 50% cases versus second 50% cases of each center) and of the procedural volume (high-volume versus low-volume centers). RESULTS: Mean age was 81.0±6.7 years, mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I, EuroSCORE II, and The Society of Thoracic Surgeons risk score were 25.6%±16.3%, 9.4%±11.0%, and 10.6%±8.5%, respectively. Median follow-up was 12 months (range, 1 to 44). Thirty-day mortality was 9.9% (77 patients). Overall 1-, 2-, and 3-year survival was 81.7%±1.5%, 76.1%±1.9%, and 67.6%±3.2%, respectively. Thirty-day mortality of the first 50% patients of each center was higher when compared with the second half (p=0.04) but 3-year survival was not different (p=0.64). Conversely, 30-day mortality at low-volume centers versus high-volume centers was similar (p=0.22). At discharge, peak and mean transprosthetic gradients were 21.0±10.3 mm Hg and 10.2±4.1 mm Hg, respectively. These values remained stable 12 and 24 months after surgery. CONCLUSIONS: Transapical TAVI provides good results in terms of early and midterm clinical and hemodynamic outcomes. Thus it appears to be a safe and effective alternative treatment for patients who are inoperable or have high surgical risk.

Mitral valve repair after papillary muscle rupture through beating heart adjustment of artificial chordae length.

Acute papillary muscle rupture results in severe mitral regurgitation and hemodynamic instability, and it carries a poor prognosis with a high mortality rate. We present a case of an 86-year-old woman affected by mitral regurgitation due to an acute posterior papillary muscle rupture. The patient underwent a mitral valve repair with annuloplasty and artificial chordae implantation. The neochorda was sutured to the posterior mitral leaflet and fixed through the left ventricle wall on the epicardium. The neochorda length was determined on the beating heart under echocardiographic view.

[Surgical therapy of coronary artery disease in the Italian cardiac surgery centers]. / Studi osservazionali trattamento della cardiopatia ischemica nei centri cardiochirurgici italiani. Risultati di una indagine conoscitiva.

BACKGROUND: We conducted a national survey on surgical therapy for coronary artery disease and its complications, with the aim to eventually identify differences in the processes of care adopted in the Italian cardiac surgery centers. METHODS: Eighty-seven Italian cardiac surgery units received a questionnaire about their general activity profile and the following interest areas: (a) surgical myocardial revascularization techniques; (b) ischemic mitral regurgitation treatment; (c) left ventricular reconstruction procedures; (d) mechanical circulatory support and heart transplantation in ischemic cardiomyopathy. RESULTS: Forty-one Centers (47.1%) returned a completely filled questionnaire. The analysis of the answers showed differences in the therapeutic approaches adopted in the various centers regarding: choice of surgical technique and grafts for myocardial revascularization; propensity to treat moderate ischemic mitral regurgitation in the setting of severe left ventricular dysfunction; propensity to treat extended myocardial scars; treatment options in ischemic cardiomyopathy with advanced heart failure. The specific center profile (volume of activity, availability of heart transplantation) seems to influence the choice among the different treatment options. CONCLUSIONS: This study may contribute to show and analyze existing differences in clinical practice between different centers. Diagnostic and therapeutic approaches (processes of care) should be frequently monitored in order to promptly single out critical areas necessitating review or further researches, to standardize decision making criteria, and to improve care appropriateness.

Intimal-type primary sarcoma of the thoracic aorta: an unusual case presenting with left arm embolization.

A case of intimal-type primary sarcoma of the thoracic aorta with unusual left arm embolization is reported.