Faculty Bibliography

When transcatheter aortic valve replacement (TAVR) was first approved for use in the United States in 2012, multiple leading surgical and cardiology societies were tasked with creating recommendations and requirements for operators and institutions starting and maintaining TAVR programs. Creation of this consensus document was challenging due to limited experience with this new technology, and a lack of robust centralized data that could be used to validate outcome measures and create benchmarks for self-assessment and improvement. Despite these limitations, this document provided government agencies a framework for regulation that ultimately determined requirements for Medicare payment for TAVR and therefore greatly determined how and where care was delivered for patients with aortic stenosis. After the proliferation of TAVR institutions throughout the US and with data from more than 100,000 cases in the STS/ACC Transcatheter Valve Therapies TM Registry, leaders of the same societies reconvened in 2018 to update their consensus document. The new recommendations include suggested personnel, facilities, training, and assessment of outcomes and competencies required to run a safe and efficient TAVR program. This article seeks to detail the changes from the original consensus document with a particular focus on issues relevant to cardiac anesthesiologists as well as important healthcare policy ramifications for patients and providers in the United States.

BACKGROUND:Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk. METHODS:We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population. RESULTS:At 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan-Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, -6.6 percentage points; 95% confidence interval [CI], -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P = 0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P = 0.02) and in lower rates of death or stroke (P = 0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation. CONCLUSIONS:Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).

OBJECTIVE:Medicare's Bundle Payment for Care Improvement(BPCI) Model 2 groups reimbursement for valve surgery into 90-day episodes of care(EOC) which include operative costs, inpatient stay, physician fees, post-acute care, and readmissions up to 90 days post-procedure. We analyzed our BPCI patients' 90-day outcomes to understand the late financial risks and implications of the bundle payment system for valve patients. METHODS:All BPCI valve patients from 10/2013 (start of risk-sharing phase) through 12/2015 were included. Readmissions were categorized as early (≤30 days) or late (31-90 days). Data were collected from institutional databases as well as Medicare claims. RESULTS:Analysis included 376 BPCI valve patients: 202 open and 174 transcatheter aortic valves (TAVR). TAVR patients were older (83.6 vs 73.8 years; p=0.001) and had higher STS predicted risk (7.1% vs 2.8%; p=0.001). Overall, 18.6% of patients (70/376) had one-or-more 90-day readmission, and total claims was on average 51% greater for these patients. Overall readmissions were more common among TAVR patients (22.4%(39/174) vs 15.3%(31/202),p=0.052) as was late readmission. TAVR patients had significantly higher late readmission claims, and early readmission was predictive of late readmission for TAVR patients only (p=0.04). CONCLUSION/CONCLUSIONS:Bundled claims for a 90-day episode of care are significantly increased in patients with readmissions. TAVR patients represent a high-risk group for late readmission, possibly a reflection of their chronic disease processes. Being able to identify patients at highest risk for 90-day readmission and the associated claims will be valuable as we enter into risk-bearing EOC agreements with Medicare.

BACKGROUND:Hemodynamic performance of prostheses after transcatheter aortic valve replacement (TAVR) is generally better than after surgical aortic valve replacement (SAVR), especially in patients with a small native annulus size. However, it remains unclear whether differences are consistent for patients with a different propensity for developing prosthesis-patient mismatch (PPM), considering annulus size and body size of patients. METHODS AND RESULTS/RESULTS:=0.81). CONCLUSIONS:Rates of PPM were significantly lower after TAVR than after SAVR across all groups of indexed annulus size, reflecting better hemodynamic performance of transcatheter versus surgical valves, irrespective of the propensity to develop PPM. More attention should be directed to prevention of PPM after SAVR. This information should be considered by the Heart Team to recommend a specific procedure or valve. CLINICAL TRIAL REGISTRATION/BACKGROUND:URL: https://www.clinicaltrials.gov . Unique identifier: NCT01586910.

BACKGROUND:Renal disease is associated with poor prognosis despite guideline-directed cardiovascular therapy, and outcomes by sex in this population remain uncertain. METHODS AND RESULTS/RESULTS:Patients (n=5213) who underwent a MitraClip procedure in the National Cardiovascular Data Registry Transcatheter Valve Therapy registry were evaluated for the primary composite outcome of all-cause mortality, stroke, and new requirement for dialysis by creatinine clearance (CrCl). Centers for Medicare and Medicaid Services-linked data were available in 63% of patients (n=3300). CrCl was <60 mL/min in 77% (n=4010) and <30 mL/min in 23% (n=1183) of the cohort. Rates of primary outcome were higher with lower CrCl (>60 mL/min, 1.4%; 30-<60 mL/min, 2.7%; <30 mL/min, 5.2%; dialysis, 7.8%; P<0.001), and all low CrCl groups were independently associated with the primary outcome (30-<60 mL/min: adjusted odds ratio, 2.32; 95% CI, 1.38-3.91; <30 mL/min: adjusted odds ratio, 4.44; 95% CI, 2.63-7.49; dialysis: adjusted hazards ratio, 4.52; 95% CI, 2.08-9.82) when compared with CrCl >60 mL/min. Rates of 1-year mortality were higher with lower CrCl (>60 mL/min, 13.2%; 30-<60 mL/min, 18.8%; <30 mL/min, 29.9%; dialysis, 32.3%; P<0.001), and all low CrCl groups were independently associated with 1-year mortality (30-<60 mL/min: adjusted hazards ratio, 1.50; 95% CI, 1.13-1.99; <30 mL/min: adjusted hazards ratio, 2.38; 95% CI, 1.78-3.20; adjusted hazards ratio: dialysis, 2.44; 95% CI, 1.66-3.57) when compared with CrCl >60 mL/min. CONCLUSIONS:The majority of patients who undergo MitraClip have renal disease. Preprocedural renal disease is associated with poor outcomes, particularly in stage 4 or 5 renal disease where 1-year mortality is observed in nearly one-third. Studies to determine how to further optimize outcomes in this population are warranted.

Background: Traditionally, hostile peripheral access patients undergo TAVR via alternative access. We describe the "transfemoral-first" (TF-1) approach in patients with hostile peripheral access. Method(s): Clinical and procedural data were obtained for all TAVR cases performed from August 2016 to July 2017. Computed tomography was used to assess iliofemoral arteries. Patients were divided into three femoral access groups: routine, hostile, and prohibitive. We attempted TF access in all patients with routine and hostile access. Hostile access was defined as: (1) arterial segments with diameter <5.0 mm; or (2) <5.5 mm with severe calcification (270-360degree arc of calcification) or severe tortuosity; or (3) severe tortuosity along with severe calcification. Outcomes of the hostile access group patients who underwent TF-1 are described. The primary endpoint was successful completion of the procedure without major complications by the intended route. The secondary endpoints were procedural complications as defined by the VARC-2 criteria. Result(s): Of 377 consecutive patients, 99.5% underwent TF-1 TAVR; two patients (0.4%) had prohibitive access. Twenty-eight (7.4%) patients had hostile access with access side mean minimal lumen diameter of 4.7 mm (range 3.8-5.4 mm). Twenty-six (92.8%) were successfully treated with TF-1 strategy. Twelve (42.8%) of the 26 patients underwent preparatory endovascular treatment prior to TAVR during the same operating room visit. There was 1 (3.5%) major or life-threatening bleeding complication and 2 (7.1%) major vascular complications. There were no deaths or strokes. Conclusion(s): Using the safe and effective endovascular approach, TF-1 TAVR is feasible for all-comers-including those with hostile access-with low complication rate. Larger studies are warranted to validate this approach.

BACKGROUND:Transcatheter aortic valve replacement (TAVR) for low gradient (LG) severe aortic stenosis (AS) with preserved left ventricular ejection fraction (LVEF) remains an area of clinical uncertainty. METHODS:Retrospective review identified 422 patients who underwent TAVR between September 4, 2014 and July 1, 2016. Procedural indication other than severe AS (n = 22) or LVEF <50% (n = 98) were excluded. Outcomes were defined by valve academic research consortium two criteria when applicable and compared between LG (peak velocity <4.0 m/s and mean gradient <40 mmHg; n = 73) and high gradient (HG) (n = 229) groups. The LG group was further categorized as low stroke volume index (SVI) (n = 41) or normal SVI (n = 32). Median follow-up was 747 days [interquartile range 220-1013]. RESULTS: = 0.39). CONCLUSION/CONCLUSIONS:Patients with preserved LVEF undergoing TAVR for severe AS with LG, including LG with low SVI, have no significant difference in adverse outcomes when compared to patients with HG.