Faculty Bibliography

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: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.

A 78 year-old man with remote type-A dissection presented with acute-onset dyspnea. Twenty-two years prior, treatment for his aortic disease required replacement of ascending and arch aneurysms with a Dacron graft using graft inclusion technique. He presented currently in cardiogenic shock. Echocardiography demonstrated new severe hypokinesis of all apical segments. Left-heart catheterization revealed a 120mmHg intra-graft gradient. CT arteriography was unrevealing, but intra-aortic ultrasound demonstrated critical intra-graft stenosis. A Palmaz stent was deployed in the stenotic region with gradient resolution. He later underwent aortic root replacement and ascending aneurysm repair (Bio-Bentall technique) and is doing well at 24 months.

BACKGROUND:The PARTNER-2A randomized trial compared outcomes of transfemoral transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in intermediate-risk patients with severe aortic stenosis. The purpose of the current study was to perform an in-depth analysis of outcomes after SAVR in PARTNER-2A. METHODS:From 1/2012-1/2014, 937 patients underwent SAVR at 57 centers. Mean age was 82±6.7 and 55% were men. Less-invasive operations were performed in 140 (15%) and concomitant procedures in 198 (21%). Major outcomes and echocardiograms were adjudicated by an independent events committee. Follow-up was 94% complete to 2 years. RESULTS:Operative mortality was 4.1% (n=38, STS PROM 5.2±2.3%), O/E 0.8, and in-hospital stroke 5.4% (n=51), twice expected. Aortic clamp and bypass times were 75±30 and 104±46 minutes. Patients having severe prosthesis-patient mismatch (n=260, 33%) had similar survival to those without (P>.9), as did those undergoing less-invasive SAVR (P=.3). Risk factors for death included cachexia (P=.004), tricuspid regurgitation (P=.01), coronary artery disease (P=.02), preoperative atrial fibrillation (P=.001), higher white cell count (P<.0001), and lower hemoglobin (P=.0002). CONCLUSIONS:In this adjudicated prospective study, SAVR in intermediate-risk patients had excellent results at 2 years. However, there were more in-hospital strokes than expected, most likely attributable to mandatory neurologic assessment post-procedure. There was no significant structural valve deterioration during 2-year follow-up. Continued long-term surveillance remains important.