Gidon Y. Perlman

First-in-man Experience of a Novel Transcatheter Repair System for Treating Severe Tricuspid Regurgitation

BACKGROUND Isolated tricuspid valve surgery is associated with high morbidity and mortality, especially in patients with prior cardiac surgery. The transcatheter Forma Repair System (Edwards Lifesciences, Irvine, California) is designed to provide a surface for native leaflet coaptation to reduce tricuspid regurgitation (TR) by occupying the regurgitant orifice area. OBJECTIVES This study sought to evaluate the feasibility and exploratory efficacy with this transcatheter repair system for the treatment of severe TR. METHODS Seven high-risk patients with severe TR and clinical signs of heart failure were declined for surgery and offered transcatheter treatment with this device. All procedures were performed within a cardiac catheterization laboratory or hybrid operating room under general anesthesia with transesophageal echocardiographic guidance. Vascular access was via the left axillary vein. Baseline characteristics, procedural and in-hospital outcomes, as well as 30-day follow-up were prospectively collected. RESULTS All patients had severe TR and New York Heart Association (NYHA) functional class II to IV (mean age 76 ± 13 years; mean logistic EuroSCORE 25.7 ± 17.4%), and underwent device implantation to improve tricuspid leaflet coaptation, thereby reducing TR. Device implantation was successful without procedural complications in all patients, with significant reductions in TR severity (moderate in 3 patients and mild in 4 patients). Median hospital length of stay was 4 days. At 30-day follow-up, all patients but 1 demonstrated improvements in NYHA functional status (to class II) with pronounced reductions in the presence and severity of peripheral edema. TR severity was assessed as being moderate at 30-day transthoracic echocardiography follow-up in all patients. No complications related to the device or vascular access were observed during follow-up. CONCLUSIONS A transcatheter-based treatment option for severe TR appears safe and feasible with this repair system. Improvements in TR severity were documented in all patients, which were accompanied by improvements in peripheral edema and functional status.

Vancouver Transcatheter Aortic Valve Replacement Clinical Pathway

We describe the development, implementation, and evaluation of a standardized clinical pathway to facilitate safe discharge home at the earliest time after transfemoral transcatheter aortic valve replacement. Between May 2012 and October 2014, the Heart Team developed a clinical pathway suited to the unique requirements of transfemoral transcatheter aortic valve replacement in contemporary practice. The components included risk-stratified minimalist periprocedure approach, standardized postprocedure care with early mobilization and reconditioning, and criteria-driven discharge home. Our aim was to reduce variation in care, identify a subgroup of patients suitable for early discharge (⩽48 hours), and decrease length of stay for all patients. We addressed barriers related to historical practices, complex multidisciplinary stakeholder engagement, and adoption of length of stay as a quality indicator. We retrospectively reviewed the experiences of 393 consecutive patients; 150 (38.2%) were discharged early. At baseline, early discharge patients had experienced less previous balloon aortic valvuloplasty, had higher left ventricular ejection fraction, better cognitive function, and were less frail than the standard discharge group (>48 hours). Early discharge was associated with the use of local anesthesia, implantation of balloon expandable device, avoidance of urinary catheter, and early removal of temporary pacemaker. Median length of stay was 1 day for early discharge and 3 days for other patients; 97.7% were discharged home. There were no differences in 30-day mortality (1.3%), disabling stroke (0.8%), or readmission (10.7%). The implementation of a transcatheter aortic valve replacement clinical pathway shifted the program’s approach to combine standardized processes and individual risk stratification. The Vancouver transcatheter aortic valve replacement clinical pathway requires a rigorous assessment to determine its efficacy, safety, and reproducibility.

Transcatheter aortic valve implantation in bicuspid aortic valve stenosis.

Bicuspid aortic stenosis (AS) is not rare in patients treated with transcatheter aortic valve implantation (TAVI). Bicuspid valves have unique anatomy which could affect the results of TAVI; however, multiple recent reports have shown that TAVI is safe and effective in this population. Paravalvular aortic regurgitation was initially found to be more frequent in bicuspid patients, but newer-generation devices have shown superior results in this respect. Higher rates of pacemaker implantation after TAVI in bicuspid AS do require further investigation. Current data suggest that bicuspid valves should not be a contraindication for TAVI, but future specific trials are needed to support this assertion.

Transcatheter aortic valve replacement with the Portico valve: one-year results of the early Canadian experience

AIMS The aim of this study was to examine the short- and medium-term outcomes of transcatheter aortic valve replacement (TAVR) with the self-expanding and repositionable Portico valve (St. Jude Medical, St. Paul, MN, USA). METHODS AND RESULTS A total of 57 patients underwent TAVR with the Portico valve between March 2012 and August 2014, representing the first-in-human experience and the entire early experience in Canada. Patients were followed up at 30 days and one year with repeat echocardiography and clinical review. Patients were 80.8±7.3 years of age, and the Society of Thoracic Surgeons predicted risk of mortality was 7.7±5.7%. All patients had a valve implanted and four patients (7%) required a second valve. At 30 days, there were two deaths (3.5%), three disabling strokes (5.3%), and new pacemakers in five (8.8%) patients. Echocardiography revealed moderate/severe aortic regurgitation in two patients (3.6%). At one year, survival was 84.2% and echocardiographic findings were unchanged. CONCLUSIONS Transcatheter aortic valve replacement with the repositionable Portico valve provides satisfactory short- and medium-term haemodynamic and clinical results.

Transapical mitral valve implantation after unclipping of a MitraClip: a glimpse into the future and treatment considerations in mitral regurgitation.

AIMS Transcatheter mitral valve implantation (TMVI) is a novel approach that may enable a less invasive effective reduction of mitral regurgitation (MR). A limitation of the MitraClip is that definitive implantation of a clip precludes future therapy with TMVI. The purpose of this paper is to describe contemporary treatment considerations in patients with mitral valve regurgitation. METHODS AND RESULTS In this report we describe an attempted MitraClip implantation which resulted in no reduction of MR severity. There was a consensus that additional clips would probably not be effective. MitraClip implantation was therefore abandoned and the clip was removed, allowing subsequent successful TMVI with the Tiara™ system three weeks later. Echocardiography revealed secure seating of the prosthesis with good mitral valve function, trivial paravalvular leakage and transvalvular gradient of 3 mmHg. The patient recovered rapidly and was discharged four days post implant. CONCLUSIONS The clinical approach towards high-risk patients with significant MR may change in the next few years. In selected patients, in whom an initial attempt with MitraClip implantation results in only limited efficacy, the clip may be retrieved during the index procedure to allow subsequent TMVI.

The prognostic importance of the diastolic pulmonary gradient, transpulmonary gradient, and pulmonary vascular resistance in patients undergoing transcatheter aortic valve replacement

To evaluate the association between markers of precapillary pulmonary hypertension (PH) and survival in transcatheter aortic valve replacement (TAVR).

OUTCOMES OF DIABETIC PATIENTS UNDERGOING PCI WITH CONTEMPORARY DRUG-ELUTING STENTS: ANALYSIS FROM THE BIONICS STUDY

Patients with diabetes mellitus and coronary artery disease are at increased risk for adverse cardiovascular events after PCI. We sought to investigate the impact of diabetes on outcomes following implantation of contemporary DES in the BioNIR Ridaforolimus-eluting coronary stent system in Coronary

Treatment of Tricuspid Regurgitation With the FORMA Repair System

Background: Tricuspid regurgitation (TR) is common and undertreated as the risk of surgery is high in this patient population. Transcatheter devices offer treatment with a lower procedural risk. The FORMA Tricuspid Valve Therapy system (Edwards Lifesciences) will be reviewed here. Device Description: The system combines a spacer placed in the regurgitant orifice and a rail, over which the spacer is delivered, that is anchored to the endocardial surface of the RV. The spacer provides a surface for leaflet coaptation. Outcomes: Eighteen compassionate care patients and 29 patients included in the US EFS trial are reviewed. Patients were elderly (76 years) and high risk (Euroscore 2 was 9.0 and 8.1%, respectively). There were 2 procedural failures in both groups. Mortality at 30 days was 0% in the compassionate group and 7% in the EFS trial. TR was reduced in both groups; 2D/3D EROA 2.1 ± 1.8 to 1.1 ± 0.9 cm2 in the EFS trial and vena contracta width 12.1 ± 3.3 to 7.1 ± 2.2 mm. Symptomatic improvement was seen in both groups; the proportion of patients in NYHA class III/IV decreased from 84 to 28% at 30 days in the EFS group, and from 94 to 21% at 1 year, in the compassionate group. Conclusions: Reduction of TR with FORMA system is feasible and sustained. Despite residual TR post-procedure, the significant relative reduction in TR severity contributes to substantial clinical improvements in patients with a FORMA device in place.

First transcatheter valve‐in‐valve implantation in an apicoaortic conduit

Apicoaortic conduit surgery is an option for treating severe aortic stenosis. The implanted conduit valve may eventually fail and require replacement; this is usually performed by repeat surgery. Treating the conduit valve with a standard transcatheter heart valve is an option that has become feasible in recent years. We describe a case of a failed 23 mm CE bioprosthesis that was successfully treated with a 23 mm Sapien XT valve as a valve‐in‐valve procedure.

A Novel Valvuloplasty Scoring Balloon Catheter for Aortic Stenosis

ABSTRACT Background: There has been a renewed interest in balloon aortic valvuloplasty (BAV) since the inception of transcatheter aortic valve replacement (TAVR) in treating aortic stenosis (AS). This study aimed to demonstrate the safety and feasibility of a novel aortic valvuloplasty balloon catheter for the treatment of symptomatic severe aortic valve stenosis. Methods: Data from 25 patients who underwent BAV with the AngioSculpt Valvuloplasty Scoring Balloon Catheter at two Canadian centers with clinical follow-up and echocardiographic assessment at 30 days, 6 months, and 12 months were analyzed. Results: Mean age of the patients was 83.6 ± 5.8 years with 68% females. Mean gradient across the aortic valve was 44.0 ± 15.1 mmHg pre- and 33.6 ± 13.8 mmHg post-valvuloplasty (average reduction of 24% post-BAV, p < 0.05). 38% of patients showed ≥ 30% aortic gradient reduction. There were no major adverse cardiovascular events. Stroke and major vascular complication rates were zero. Two patients had moderate aortic regurgitation post-valvuloplasty. Conclusion: Preliminary results with a novel valvuloplasty scoring balloon for aortic stenosis demonstrate no safety concerns with a favorable gradient reduction. Additional studies will be required to demonstrate clinical utility in selected patients.