Budget impact analysis of transcatheter aortic valve replacement in low, intermediate, and high-risk patients with severe aortic stenosis in Saudi Arabia.

AIMS: A budget impact analysis (BIA) comparing transcatheter aortic valve replacement (TAVR) with SAPIEN 3 and surgical aortic valve replacement (SAVR) for severe, symptomatic aortic stenosis among patients of low, intermediate, and high surgical risk from the perspective of the public and private sectors in Saudi Arabia. MATERIALS AND METHODS: A Markov model was developed with six states to calculate the budget impact from time of either TAVR or SAVR intervention up to 5 years. We compared the budget effects of new permanent pacemaker implantation (PPI), new onset atrial fibrillation (AF), major/disabling stroke (MDS), and surgical site infections (SSI). One-way sensitivity analyses (OWSA) were performed on cost and probability inputs. RESULTS: Analysis of the base case parameters suggests TAVR vs. SAVR is budget saving among intermediate- and high-risk patients at 5 years. TAVR vs. SAVR for low surgical risk reaches budget neutrality at 5 years. TAVR is associated with higher costs for PPI and budget savings for MDS, AF, and SSI. TAVR also results in savings for non-device costs due to fewer human resource uses and shorter procedure durations. Similarly, TAVR is associated with cost savings due to shorter hospital intensive care unit (ICU) and non-ICU stays. The OWSA consistently revealed that SAVR non-device theater costs were the leading cost driver across all surgical risk levels. LIMITATIONS: This is the first budget impact analysis of its kind in Saudi Arabia and future research is needed on costing TAVR and SAVR procedures, the economic impact of SSI, and corroborating estimates for the public and private sectors. CONCLUSIONS: Payers, providers, and policymakers increasingly turn to results of BIA to inform technologies affordability decisions. TAVR with SAPIEN 3 appears to generate savings vs. SAVR from a budget impact perspective across various surgical risk levels in Saudi Arabia.

The Transcatheter Aortic Valve Implantation (TAVI) Quality Report: A Call to Arms for Improving Quality in Canada.

Transcatheter aortic valve implantation (TAVI) is a disruptive technology that has dramatically changed the way clinicians care for patients with aortic stenosis. In 15 short years, this technology has progressed from first-in-human to the standard of care for high-risk and inoperable patients with aortic stenosis. In 2016 the Canadian Cardiovascular Society published the first ever report of quality of care for TAVI in Canada. This report provided multiple insights into evaluating such care delivered to Canadians and the challenges that lie ahead. In this article, we summarize these challenges and encourage cardiologists to join the call to arms for improving quality of TAVI care in Canada.

A Bicuspid Aortic Valve Imaging Classification for the TAVR Era.

OBJECTIVES: This study sought to evaluate transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) aortic stenosis (AS), with a particular emphasis on TAVR-directed bicuspid aortic valve imaging (BAVi) of morphological classification. BACKGROUND: TAVR has been used to treat BAV-AS but with heterogeneous outcomes and uncertainty regarding the relevance of morphology. METHODS: In 14 centers in the United States, Canada, Europe, and Asia, 130 BAV-AS patients underwent TAVR. Baseline cardiac computed tomography (CT) was analyzed by a dedicated Corelab. Outcomes were assessed in line with Valve Academic Research Consortium criteria. RESULTS: Bicommissural BAV (vs. tricommissural) accounted for 68.9% of those treated in North America, 88.9% in Europe, and 95.5% in Asia (p = 0.003). For bicommissural bicuspids, non-raphe type (vs. raphe type) BAV accounted for 11.9% of those treated in North America, 9.4% in Europe, and 61.9% in Asia (p < 0.001). Overall rates of 30-day mortality (3.8%) and cerebrovascular events (3.2%) were favorable and similar among anatomical subsets. The rate of new permanent pacemaker insertion was high (26.2%) and similar between balloon-expandable (BE) and self-expanding (SE) designs (BE: 25.5% vs. SE: 26.9%; p = 0.83); there was a trend to greater permanent pacemaker insertion in BE TAVR in the presence of coronary cusp fusion BAV morphology. Paravalvular aortic regurgitation (PAR) ≥ moderate was 18.1% overall but lower at 11.5% in those with pre-procedural CT. In the absence of pre-procedural CT, there was an excess of PAR in BE TAVR that was not the case in those with a pre-procedural CT; SE TAVR required more post-dilation. Predictors of PAR included intercommissural distance for bicommissural bicuspids (odd ratio [OR]: 1.37; 95% confidence interval [CI]: 1.02 to 1.84; p = 0.036) and lack of a baseline CT for annular measurement (OR: 3.03; 95% CI: 1.20 to 7.69; p = 0.018). CONCLUSIONS: In this multicenter study, TAVR achieved favorable outcomes in patients with pre-procedural CT, with the exception of high permanent pacemaker rates for all devices and shapes.

Quality of Care for Transcatheter Aortic Valve Implantation: Development of Canadian Cardiovascular Society Quality Indicators.

Transcatheter aortic valve implantation (TAVI) is a relatively new procedure to treat aortic stenosis in patients at high surgical risk, and it is becoming increasingly available in Canada. Variation exists in the clinical care, program coordination, evaluation, and funding across provinces and centres. As a part of the Canadian Cardiovascular Society (CCS) quality initiative, the TAVI Quality Indicator (QI) Working Group was established in 2014 to develop a set of indicators to measure quality of care for Canadians undergoing TAVI for aortic stenosis. The TAVI QI Working Group is composed of expert clinical and government agency representatives. The group developed consensus agreements for the selection of the first iteration of measurable structure, process, and outcome indicators reflective of the quality of care for patients undergoing TAVI. The objectives of the project are to develop quality indicators with the eventual goal of standardizing TAVI quality reports across Canada and to support local and national quality assurance, as well as engage multiple stakeholders to build a national strategy for the evaluation of quality of care.

The impact of calcium volume and distribution in aortic root injury related to balloon-expandable transcatheter aortic valve replacement.

BACKGROUND: A detailed assessment of calcium within the aortic root may provide important additional information regarding the risk of aortic root injury during transcatheter heart valve replacement (TAVR). OBJECTIVE: We sought to delineate the effect of calcium volume and distribution on aortic root injury during TAVR. METHODS: Thirty-three patients experiencing aortic root injury during TAVR with a balloon-expandable valve were compared with a control group of 153 consecutive TAVR patients without aortic root injury (as assessed by post-TAVR multidetector CT). Using commercial software to analyze contrast-enhanced pre-TAVR CT scans, calcium volume was determined in 3 regions: (1) the overall left ventricular outflow tract (LVOT), extending 10 mm down from the aortic annulus plane; (2) the upper LVOT, extending 2 mm down from the annulus plane; and (3) the aortic valve region. RESULTS: Calcium volumes in the upper LVOT (median, 29 vs 0 mm(3); P < .0001) and overall LVOT (median, 74 vs 3 mm(3); P = .0001) were higher in patients who experienced aortic root injury compared with the control group. Calcium in the aortic valve region did not differ between groups. Upper LVOT calcium volume was more predictive of aortic root injury than overall LVOT calcium volume (area under receiver operating curve [AUC], 0.78; 95% confidence interval, 0.69-0.86 vs AUC, 0.71; 95% confidence interval, 0.62-0.82; P = .010). Upper LVOT calcium below the noncoronary cusp was significantly more predictive of aortic root injury compared to calcium underneath the right coronary cusp or the left coronary cusp (AUC, 0.81 vs 0.68 vs 0.64). Prosthesis oversizing >20% (likelihood ratio test, P = .028) and redilatation (likelihood ratio test, P = .015) improved prediction of aortic root injury by upper LVOT calcium volume. CONCLUSION: Calcification of the LVOT, especially in the upper LVOT, located below the noncoronary cusp and extending from the annular region, is predictive of aortic root injury during TAVR with a balloon-expandable valve.

Structural heart diseases interventional training in Canada.

Structural heart disease interventions have evolved into an important component of interventional cardiology fellowship programs worldwide. Given the complexity of such interventions, the breadth of knowledge needed for optimal patient selection and postprocedural management, and the skills to perform them efficiently, advanced training has become mandatory. Postgraduate medical training in Canada has always been on the cutting edge of new technology, and excellent care is provided to the increasing population of adult patients with congenital heart disease. The current survey sought to collect relevant information and assess the opinion of interventional cardiology program directors in Canada regarding training in structural interventions. Our study reports the approximate number of structural procedures performed by interventional cardiology fellows in Canadian interventional cardiology fellowship programs, the form of the structural training, and the suggestions of program directors who are actively trying to integrate structural training into interventional cardiology fellowship programs.

Anatomical and procedural features associated with aortic root rupture during balloon-expandable transcatheter aortic valve replacement.

BACKGROUND: Aortic root rupture is a major concern with balloon-expandable transcatheter aortic valve replacement (TAVR). We sought to identify predictors of aortic root rupture during balloon-expandable TAVR by using multidetector computed tomography. METHODS AND RESULTS: Thirty-one consecutive patients who experienced left ventricular outflow tract (LVOT)/annular/aortic contained/noncontained rupture during TAVR were collected from 16 centers. A caliper-matched sample of 31 consecutive patients without annular rupture, who underwent pre-TAVR multidetector computed tomography served as a control group. Multidetector computed tomography assessment included short- and long-axis diameters and cross-sectional area of the sinotubular junction, annulus, and LVOT, and the presence, location, and extent of calcification of the LVOT, as well. There were no significant differences between the 2 groups in any preoperative clinical and echocardiographic variables. Aortic root rupture was identified in 20 patients and periaortic hematoma in 11. Patients with root rupture had a higher degree of subannular/LVOT calcification quantified by the Agatston score (181.2±211.0 versus 22.5±37.6, P<0.001), and a higher frequency of ≥20% annular area oversizing (79.4% versus 29.0%, P<0.001) and balloon postdilatation (22.6% versus 0.0%, P=0.005). In conditional logistic regression analysis for the matched data, moderate/severe LVOT/subannular calcifications (odds ratio, 10.92; 95% confidence interval, 3.23-36.91; P<0.001) and prosthesis oversizing ≥20% (odds ratio, 8.38; 95% confidence interval, 2.67-26.33; P<0.001) were associated with aortic root contained/noncontained rupture. CONCLUSIONS: This study demonstrates that LVOT calcification and aggressive annular area oversizing are associated with an increased risk of aortic root rupture during TAVR with balloon-expandable prostheses. Larger studies are warranted to confirm these findings.

Diagnosis and therapy for pulmonary arteriovenous fistula in patients with presumed patent foramen ovale.

An increasing number of patients are being referred for PFO closure for prevention of recurrent paradoxical embolism. Diagnosis is usually made using hand agitated echo bubble contrast with transthoracic or transesophageal echo. It is inevitable that some of these patients will have pulmonary arteriovenous fistulae (PAVF), either with or without associated PFO, which may be the sole cause of paradoxical embolism, or remain after PFO closure as a source of continued embolization. Intravenous contrast echo for the diagnosis of PFO is both insensitive and nonspecific. We describe a method to diagnose and localize PAVF during a catheterization procedure using intracardiac echo in conjunction with selective injection of bubble contrast into the pulmonary arteries. This allows for the rapid and accurate diagnosis of PAVF when a PFO is not found and for the exclusion of associated PAVF when PFO exists.

Percutaneous approaches to mitral regurgitation.

Percutaneous therapy for mitral repair has emerged over the past several years as an investigational option for treating mitral regurgitation (MR). A variety of novel methods to treat MR using a percutaneous route have been developed. Most of these approaches are modifications of surgical techniques, some established and some obscure. The basic surgical approaches to mitral repair are annuloplasty and leaflet repair. Catheter-based devices mimic or approximate these surgical approaches. MR as a disease process is heterogeneous, and different therapeutic approaches are needed for different etiologies of MR and morphologies of the mitral apparatus. Primary leaflet diseases are mitral prolapse and fibroelastic deficiency. Secondary, or functional, MR exists when the leaflets are normal. Functional ischemic MR and functional MR related to heart failure occur in different populations and historically have had different responses to surgical therapy. Leaflet repair using a percutaneous clip has been accomplished for patients with mitral valve prolapse and also some patients with functional MR. Indirect annuloplasty via the coronary sinus has shown promising early human trial results in patients with functional MR. Direct annuloplasty and left ventricular chamber remodeling technologies are in the earliest stages of human application. This group of approaches is being studied as an alternative to surgery for selected patients. The MitraClip (Evalve, Menlo Park, CA) for leaflet repair has been approved for use in Europe and is being applied predominantly to high-risk surgical patients with either functional or degenerative, organic MR. One of the coronary sinus devices has received approval in Europe as well. This complex clinical landscape has made device development, trial design, and patient selection complicated. Steady progress in the field is being made. Many patients with functional MR who are currently treated medically will be the subject of upcoming trials. Catheter methods for mitral repair promise to serve some patients currently considered high risk for surgery, and some patients may have catheter therapy as an alternative to surgery.