Munich Comparative Study: Prospective Long-Term Outcome of the Transcatheter Melody Valve Versus Surgical Pulmonary Bioprosthesis With Up to 12 Years of Follow-Up.

BACKGROUND: Percutaneous pulmonary valve implantation (PPVI) has become an important treatment of right ventricular outflow tract dysfunction. Studies directly comparing the long-term outcome of PPVI with the Melody valve to surgical pulmonary valve replacement (SPVR) are lacking. METHODS: All patients treated with PPVI with the Melody valve and SPVR between January 2006 and December 2018 in our center were enrolled into a database and investigated with a standard follow-up protocol. The current study compares the outcomes in means of survival, reinterventions, infectious endocarditis, and performance of the valves. RESULTS: The study included 452 patients, of whom 241 were treated with PPVI with the Melody valve and 211 patients with SPVR with different types of valves. Median follow-up time was 5.4 years (3 months to 12.5 years), and the total observation was 2449 patient-years. Estimated survival after 10 years was 94% in the Melody group and 92% in the SPVR group (P=0.47). There was no difference in the estimated survival free of surgery on the implanted valve at 10 years (Melody, 87%, versus SPVR, 87%; P=0.54) or in the survival with the originally implanted pulmonary valve (Melody group, 80%; SPVR group, 73%; P=0.46) between both groups. The annualized incidence of infective endocarditis was 1.6% in the Melody group and 0.5% in the SPVR group, and the estimated survival free of endocarditis did not differ significantly between groups (Melody group, 82%; SPVR group, 86%; P=0.082). Survival free of valve replacement because of infective endocarditis was comparable between both groups (Melody, 88%; SPVR, 88%; P=0.35). CONCLUSIONS: PPVI with the Melody valve and SPVR provides similar survival, freedom of reinterventions, and infective endocarditis with or without the need of replacement of the pulmonary valve. Being less invasive, PPVI should be considered a method for treatment for patients with dysfunctional right ventricular outflow tracts.

The Sapien valve provides enough grip to be implanted in pulmonary position without a pre-stent.

BACKGROUND: Pre-stenting is a widely used technique for transcatheter pulmonary valve implantation (TPVI). For the Melody valve a pre-stent creates a reliable and solid landing zone. In contrast to the Melody valve, the Edwards Sapien valve consists of a strong balloon expandable stent designed for implantation in the aortic position. The usage of a Sapien valve in pulmonary position might therefore obviate the need of a pre-stent. METHODS: This retrospective, single centre study reviewed the procedural outcomes of patients receiving the Sapien XT transcatheter valve in pulmonary position without prior implantation of a pre-stent. All consecutive patients with dysfunctional right ventricle to pulmonary artery (RV-PA) conduits or with dysfunctional pulmonary valve treated at the German Heart Centre in Munich were included in this study. RESULTS: We report on successful implantation of a Sapien XT/3 without usage of a pre-stent. CONCLUSIONS: Abandonment of the pre-stent simplified the procedure and reduces the radiation burden for the patients.

Retrieval of large Occlutech Figula Flex septal defect occluders using a commercially available bioptome: proof of concept.

OBJECTIVES: This study aimed to develop a method for retrieval of the new meshed nitinol atrial septal defect occluders - Ceraflex and Occlutech. BACKGROUND: The newly developed atrial septal defect occluders have potential benefits considering implantation, but concerns regarding their removal in case of embolisation have been raised. METHODS: Over 21 years, 1449 patients underwent interventional atrial septal defect occlusion in our institution. We reviewed the cases of embolisation of the device, developed a strategy for device removal, and tested it on the benchside and in animal tests. RESULTS: In 11 patients (0.8%), the intended atrial septal defect occlusion was complicated by an embolisation of the device. In contrast to the Amplatzer septal occluders, retrieval of Occlutech devices larger than 16 mm with snare techniques was impossible. In benchside tests, this was confirmed and a new method for removal of large meshed devices was developed. This involved the commercially available Maslanka® biopsy forceps. The feasibility of this technique in vivo was tested in a pig model. During animal tests, using the Maslanka biopsy forceps it was possible to interventionally retrieve embolised Ceraflex and Occlutech devices of different sizes - 10, 16, 30, and 40 mm - into a 12-F sheath. CONCLUSION: It was impossible to retrieve Occlutech and Ceraflex devices larger than 16 mm into a large sheath in vivo and during benchside tests. However, this was feasible on the bench and in vivo using the Maslanka biopsy forceps even with the largest available devices.

Coarctation of the aorta-stenting via Glidesheath Slender in a newborn with recoarctation early after a Norwood operation.

In this article, we report on a newborn with hypoplastic left heart syndrome in whom recoarctation of the aorta was treated with a bare metal stent (Cook Formula 414 Stent) in the early postoperative period after a Norwood procedure. To reduce the risk for scarring and occluding the femoral artery the stent was implanted via 5F Glidesheath Slender sheath.

Tricuspid Regurgitation Does Not Impact Right Ventricular Remodeling After Percutaneous Pulmonary Valve Implantation.

OBJECTIVES: This study sought to investigate the impact of tricuspid regurgitation (TR) on right ventricular function after percutaneous pulmonary valve implantation (PPVI). BACKGROUND: PPVI provides a less invasive alternative to surgery in patients with right ventricular-to-pulmonary artery (RV-PA) conduit dysfunction. Recovery of the right ventricle has been described after PPVI for patients with pulmonary stenosis and for those with pulmonary regurgitation. Additional TR enforces RV dysfunction by supplemental volume overload. Limited data are available on the potential of the right ventricle to recover in such a specific hemodynamic situation. METHODS: In a matched cohort study, we compared patients who underwent PPVI with additional TR with those without TR. RESULTS: The degree of TR improved in 83% of the patients. In our patients (n = 36) exercise capacity and right ventricular volume index improved similarly 6 months after PPVI in patients with and without important TR. None of them had significant TR in the long-term follow-up of median 78 months. CONCLUSIONS: PPVI improves not only RV-PA-conduit dysfunction, but also concomitant TR. In patients with a dysfunctional RV-PA conduit and TR, the decision whether to fix TR should be postponed after PPVI.

A Single US Center Experience of Transbronchial Lung Cryobiopsy for Diagnosing Interstitial Lung Disease With a 2-Scope Technique.

BACKGROUND: Transbronchial lung cryobiopsy (TBLC) has been used to establish the diagnosis of interstitial lung disease (ILD) in recent years. The technique and diagnostic yield vary among institutions. We report a new 2-scope technique and the results of TBLC in our institution. METHODS: This is a retrospective chart review of patients who underwent TBLC for evaluation of ILD. Bronchoscopy with TBLC was performed by a board-certified interventional pulmonologist with a 2-scope technique under general anesthesia. RESULTS: A total of 74 patients underwent TBLC with a 2-scope technique. Their mean age was 54±14 years. The mean tissue surface area was 63.54±6.76 mm. The average anesthesia time was 80.66 minutes. The diagnostic yield was 87.84%. The most common diagnosis was sarcoidosis pneumothorax, which occurred in 5 cases (7%). There was 1 case with bronchoscopic-related respiratory failure associated with significant bleeding. Death occurred in 3 cases (4%), which is comparable to recent mortality data for "elective" surgical lung biopsy for ILD (1.7% to 4.2%). CONCLUSION: TBLC with a 2-scope technique could be an alternative method for diagnosing various types of ILD in patients unfit for surgical lung biopsy. Further prospective studies should clarify its role in the diagnostic armamentarium for undiagnosed ILDs.