Expanding the Spectrum of TEER Suitability: Evidence From the EXPAND G4 Post Approval Study.

BACKGROUND: Anatomical and clinical criteria to define mitral transcatheter edge-to-edge repair (TEER) "unsuitability" have been proposed on the basis of a Heart Valve Collaboratory consensus opinion from physician experience with early-generation TEER devices but lacked an evidence-based approach. OBJECTIVES: The aim of this study was to explore the spectrum of TEER suitability using echocardiographic and clinical outcomes from the EXPAND G4 real-world postapproval study. METHODS: EXPAND G4 is a global, prospective, multicenter, single-arm study that enrolled 1,164 subjects with mitral regurgitation (MR) treated with the MitraClip G4 System. Three groups were defined using the Heart Valve Collaboratory TEER unsuitability criteria: 1) risk of stenosis (RoS); 2) risk of inadequate MR reduction (RoIR); and 3) subjects with baseline moderate or less MR (MMR). A TEER-suitable (TS) group was defined by the absence of these characteristics. Endpoints included independent core laboratory-assessed echocardiographic characteristics, procedural outcomes, MR reduction, NYHA functional class, Kansas City Cardiomyopathy Questionnaire score, and major adverse events through 30 days. RESULTS: Subjects in the RoS (n = 56), RoIR (n = 54), MMR (n = 326), and TS (n = 303) groups had high 30-day MR reduction rates (≤1+: RoS 97%, MMR 93%, and TS 91%; ≤2+: RoIR 94%). Thirty-day improvements in functional capacity (NYHA functional class I or II at 30 days vs baseline: RoS 94% vs 29%, RoIR 88% vs 30%, MMR 79% vs 26%, and TS 83% vs 33%) and quality of life (change in Kansas City Cardiomyopathy Questionnaire score: RoS +27 ± 26, RoIR +16 ± 26, MMR +19 ± 26, and TS +19 ± 24) were safely achieved in all groups, with low major adverse events (<3%) and all-cause mortality (RoS 1.8%, RoIR 0%, MMR 1.5%, and TS 1.3%). CONCLUSIONS: Patients previously deemed TEER unsuitable can be safely and effectively treated with the mitral TEER fourth-generation device.

Efficacy of MitraClip and continued multidisciplinary cardiac rehabilitation in preventing readmission of an older heart failure patient with severe multivalvular disease: A case report.

The recommendations for the treatment of heart failure patients with severe multivalvular disease are not clear. We present a successful case of an older patient with heart failure and severe multivalvular disease in whom rehospitalization was prevented by a combination of MitraClip implantation (Abbott Vascular, Santa Clara, CA, USA) and continued multidisciplinary cardiac rehabilitation. An 85-year-old male patient presented with New York Heart Association (NYHA) class III severe mitral regurgitation (MR), severe aortic valve regurgitation (AR), and severe tricuspid valve regurgitation (TR). As first choice of treatment, surgical double valve replacement and tricuspid annuloplasty were considered. However, considering his age, pre-frailty condition, risks of surgery, and the desire of the patient, the heart team percutaneously implanted the MitraClip system. After implantation of one MitraClip (placed centrally on the A2/P2 scallops), the severity of the patient's MR decreased to mild from moderate-severe. He was followed up with multidisciplinary inpatient care and outpatient cardiac rehabilitation. At 1 year follow-up, he remained in stable condition at NYHA class I, and echocardiography at this time revealed moderate MR and TR and severe AR, and he has not required hospital readmission. Learning objective: This case report showed that a combination of MitraClip implantation (Abbott Vascular, Santa Clara, CA, USA) and continued multidisciplinary cardiac rehabilitation may be effective in preventing readmission in older patients with heart failure and severe multivalvular disease.

Iatrogenic Atrial Septal Defect Requiring Transcatheter Closure Following Transcatheter Mitral Valve Repair.

BACKGROUND: Transcatheter mitral valve repair with the MitraClip system has been established in selected high-risk patients. The MitraClip procedure results in a relatively large iatrogenic atrial septal defect (iASD). This study aimed to investigate the prevalence and clinical course of iASD requiring transcatheter closure following the MitraClip procedure.Methods and Results: This study was conducted at all 59 institutions that perform transcatheter mitral valve repair with the MitraClip system in Japan. The data of patients on whom transcatheter iASD closure was performed were collected. Of the 2,722 patients who underwent the MitraClip procedure, 30 (1%) required transcatheter iASD closure. The maximum iASD size was 9±4 mm (range, 3-18 mm). The common clinical course of transcatheter iASD closure was hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt. Of the 30 patients, 22 (73%) required transcatheter closure within 24 h following the MitraClip procedure, including 12 with hypoxemia and 5 with right-sided heart failure complicated with cardiogenic shock. Of the 5 patients, 2 required mechanical circulatory support devices. Twenty-one patients immediately underwent transcatheter iASD closure, and hemodynamic deteriorations were resolved; however, 1 patient died without having undergone transcatheter closure. CONCLUSIONS: Transcatheter iASD closure was required in 1% of patients who underwent the MitraClip procedure. Many of these patients immediately underwent transcatheter iASD closure because of hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt.

Right-to-Left Shunt Through Iatrogenic Atrial Septal Defect After MitraClip Procedure.

OBJECTIVES: The aim of this study was to investigate the incidence, characteristics, hemodynamic conditions, and clinical significance of right-to-left (R-L) shunt through an iatrogenic atrial septal defect (iASD) after the MitraClip procedure. BACKGROUND: R-L shunt through an iASD after the MitraClip procedure has not been well investigated. METHODS: From 2014 to 2017, 385 consecutive patients with mitral regurgitation underwent the MitraClip procedure. iASD was assessed using intraprocedural transesophageal echocardiography. Right and left heart catheterization was used to assess the hemodynamic status of patients. All patients provided written informed consent for the procedure. All data for this study were collected from an established interventional cardiology laboratory database approved by the Cedars-Sinai Medical Center Institutional Review Board. RESULTS: R-L shunt was observed in 20 patients (5%). In 7 of these patients (35%), R-L shunt was accompanied by acute deoxygenation. Prevalence of severe tricuspid regurgitation (55% vs. 20%; p = 0.001), serum B-type natriuretic peptide (664 pg/ml [434 to 1,169 pg/ml] vs. 400 pg/ml [195 to 699 pg/ml]; p = 0.006), mean pulmonary artery pressure (38 mm Hg [34 to 45 mm Hg] vs. 29 mm Hg [22 to 37 mm Hg]; p < 0.001), and right atrial pressure (19 mm Hg [13 to 20 mm Hg] vs. 10 mm Hg [7 to 14 mm Hg]; p < 0.001) were significantly higher in patients with R-L shunt than in those with left-to-right shunt. Patients with R-L shunt also showed a more prominent reduction in the left atrial V-wave and mean pressure from baseline to post-procedure compared with those with left-to-right shunt (-22.8 ± 2.6 mm Hg vs. -11.8 ± 0.9 mm Hg [p = 0.002] and -7.9 ± 0.8 mm Hg vs. -4.0 ± 0.4 mm Hg [p = 0.003], respectively). CONCLUSIONS: R-L shunt through an iASD was observed in 5% of patients who underwent the MitraClip procedure and in one-third of patients with R-L shunt presented acute deoxygenation. Elevated right atrial pressure concomitant with pulmonary hypertension and significant reduction in left atrial pressure after MitraClip deployment were associated with R-L shunt.

Designs of a microwave TE011 mode cavity for a space borne H-maser.

Method of Lines and Finite Element Analysis investigations have been performed to optimize parameters in a TE011 mode cavity resonator suitable for a spaceborne hydrogen maser. We report on designs that were explored to find a global maximum in the important design parameters for the microwave cavity used in a hydrogen maser. The criteria sought in this exercise were both the minimization of the total volume of the cavity and the maximization of the product of the z-component of the magnetic energy filling factor and the cavity TE011 mode Q-factor (Q.eta). Different configurations were studied. They were a sapphire tube in a copper cylinder, a sapphire tube in a copper cylinder with Bragg reflectors, and spherical copper cavities both empty and sapphire-lined on the inside cavity surface. At 320 K, the simulations resulted in an optimum product Q.eta = 4.9 x 10(4), with an inner cavity radius of 80 mm and unity aspect ratio. This represents a 54% improvement over an earlier design. The expected increase in the product Q . eta) with the inclusion of Bragg reflectors to the sapphire tube was not achieved. Moreover, the z-component of the magnetic energy filling factor was greatly reduced due to an increase in the radial magnetic field. The sapphire-lined spherical cavity showed no better performance than an equivalent-sized empty copper spherical cavity. For the empty cavity the simulations resulted in the product Q.eta = 4.4 x 10(4). The empty spherical cavity resonator is not suitable for the spaceborne hydrogen maser as the total volume in this case is 33% larger than that of the optimized sapphire tube resonator.