Multiphase Assessment of Mitral Annular Dynamics in Consecutive Patients With Significant Mitral Valve Disease.

OBJECTIVES: The aim of this study was to clarify the dynamics of the mitral annulus throughout the cardiac cycle and its relevance to transcatheter mitral valve replacement (TMVR) sizing and case selection. BACKGROUND: Limited data are available regarding the relevance of mitral annular (MA) and neo-left ventricular outflow tract (LVOT) dynamics in the overall population presenting with significant mitral valve disease. METHODS: Patients attending a combined surgical-transcatheter heart valve clinic for severe symptomatic mitral valve disease were assessed using multiphase computed tomography. The relative influence of MA and neo-LVOT dynamics to TMVR case selection was studied. RESULTS: A total of 476 patients with significant mitral valve disease were evaluated. In 99 consecutive patients with severe mitral regurgitation, a 10-phase assessment showed that the mitral annulus was on average largest in late systole. On comparing maximal MA dimension with late systolic dimension, TMVR size assignment changed in 24.2% of patients. If the average MA perimeter was used to determine sizing, 48.5% were excluded because of MA dimension being too large; in a multiphase assessment of the neo-LVOT, an additional 16.2% were excluded on the basis of neo-LVOT dimension. In an expanded series of 312 consecutive patients, selection protocol influenced anatomical exclusion: a manufacturer-proposed early systolic approach excluded 69.2% of patients, whereas a late systolic approach excluded 82.7% of patients, the vast majority because of large mitral annuli. CONCLUSIONS: Contemporary TMVR can treat only a minority of patients with severe mitral regurgitation, principally because of limitations of large MA dimension.

Minimizing Permanent Pacemaker Following Repositionable Self-Expanding Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study sought to minimize the risk of permanent pacemaker implantation (PPMI) with contemporary repositionable self-expanding transcatheter aortic valve replacement (TAVR). BACKGROUND: Self-expanding TAVR traditionally carries a high risk of PPMI. Limited data exist on the use of the repositionable devices to minimize this risk. METHODS: At NYU Langone Health, 248 consecutive patients with severe aortic stenosis underwent TAVR under conscious sedation with repositionable self-expanding TAVR with a standard approach to device implantation. A detailed analysis of multiple factors contributing to PPMI was performed; this was used to generate an anatomically guided MInimizing Depth According to the membranous Septum (MIDAS) approach to device implantation, aiming for pre-release depth in relation to the noncoronary cusp of less than the length of the membranous septum (MS). RESULTS: Right bundle branch block, MS length, largest device size (Evolut 34 XL; Medtronic, Minneapolis, Minnesota), and implant depth > MS length predicted PPMI. On multivariate analysis, only implant depth > MS length (odds ratio: 8.04; 95% confidence interval: 2.58 to 25.04; p < 0.001) and Evolut 34 XL (odds ratio: 4.96; 95% confidence interval: 1.68 to 14.63; p = 0.004) were independent predictors of PPMI. The MIDAS approach was applied prospectively to a consecutive series of 100 patients, with operators aiming to position the device at a depth of < MS length whenever possible; this reduced the new PPMI rate from 9.7% (24 of 248) in the standard cohort to 3.0% (p = 0.035), and the rate of new left bundle branch block from 25.8% to 9% (p < 0.001). CONCLUSIONS: Using a patient-specific MIDAS approach to device implantation, repositionable self-expanding TAVR achieved very low and predictable rates of PPMI which are significantly lower than previously reported with self-expanding TAVR.

Preprocedural P2Y12 inhibition and decrease in platelet count following transcatheter aortic valve replacement.

BACKGROUND: Thrombocytopenia after transcatheter aortic valve replacement (TAVR) is associated with adverse clinical outcomes. Whether preprocedural P2Y12 inhibition prevents postprocedural thrombocytopenia is uncertain. METHODS: This retrospective analysis identified consecutive patients (n = 266) undergoing TAVR between November 2016 and July 2017. Preprocedure clopidogrel load ≥300 mg or maintenance P2Y12 inhibitor therapy defined preprocedural P2Y12 inhibition. Patients who did not consent for the registry (n = 8), with baseline severe thrombocytopenia (<90 × 103 platelets/µL; n = 14), or without baseline platelet count (n = 4) were excluded. The primary outcome was proportion of patients who developed >20% decrease in platelet count from baseline to day 1 post-TAVR. RESULTS: Patients with (n = 134) versus without (n = 106) preprocedural P2Y12 inhibition had no differences in platelet count at baseline. Patients with preprocedural P2Y12 inhibition had a significantly lower proportion of the primary outcome (34.3% vs. 57.5%, p = .001) and a lower absolute decrease in platelet count (32.8 × 103 vs. 45.8 × 103 platelet/µL, p = .01). Of patients without baseline thrombocytopenia (n = 198), a numerically lower rate of patients with versus without preprocedural P2Y12 inhibition developed thrombocytopenia on day 1 post-TAVR (25.5% vs. 36.4%, p = .1). CONCLUSION: Patients who received preprocedural P2Y12 inhibition prior to TAVR were less likely to demonstrate a decrease in platelet count after TAVR. Prospective studies to further understand the clinical implication of these findings are warranted.

Ninety-Day Readmissions of Bundled Valve Patients: Implications for Healthcare Policy.

Medicare's Bundle Payment for Care Improvement (BPCI) Model 2 groups reimbursement for valve surgery into 90-day episodes of care, which include operative costs, inpatient stay, physician fees, postacute care, and readmissions up to 90 days postprocedure. We analyzed our BPCI patients' 90-day outcomes to understand the late financial risks and implications of the bundle payment system for valve patients. All BPCI valve patients from October 2013 (start of risk-sharing phase) to December 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. 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 Society of Thoracic Surgery 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 claim 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). 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 episodes of care agreements with Medicare.

Reengineering valve patients' postdischarge management for adapting to bundled payment models.

BACKGROUND: Bundled Payments for Care Improvement (BPCI) initiatives were developed by Medicare in an effort to reduce expenditures while preserving quality of care. Payment model 2 reimburses based on a target price for 90-day episode of care postprocedure. The challenge for valve patients is the historically high (>35%) 90-day readmission rate. We analyzed our institutional cardiac surgical service line adaptation to this initiative. METHODS: On May 1, 2015, we instituted a readmission reduction initiative (RRI) that included presurgical risk stratification, comprehensive predischarge planning, and standardized postdischarge management led by cardiac nurse practitioners (CNPs) who attempt to guide any postdischarge encounters (PDEs). A prospective database also was developed, accruing data on all cardiac surgery patients discharged after RRI initiation. We analyzed detailed PDEs for all valve patients with complete 30-day follow-up through November 2015. RESULTS: Patients included 219 surgical patients and 126 transcatheter patients. Sixty-four patients had 79 PDEs. Of these 79 PDEs, 46 (58.2%) were guided by CNPs. PDEs were due to fluid overload/effusion (21, 27%), arrhythmia (17, 22%), bleeding/thromboembolic events (13, 16%), and falls/somatic complaints (12, 15%). Thirty-day readmission rate was 10.1% (35/345). Patients with transcatheter aortic valve replacement had a higher rate of readmission than surgical patients (15.0% vs 6.9%), but were older with more comorbidities. The median readmission length of stay was 2.0 days (interquartile range 1.0-5.0 days). Compared with 2014, the 30-day readmission rate for BPCI decreased from 18% (44/248) to 11% (20/175), P = .05. CONCLUSIONS: Our reengineering of pre/postdischarge management of BPCI valve patients under tight CNP control has significantly reduced costly 30-day readmissions in this high-risk population.

Practices and complications of vascular closure devices and manual compression in patients undergoing elective transfemoral coronary procedures.

Femoral arterial puncture is the most common access method for coronary angiography and percutaneous coronary interventions (PCIs). Access complications, although infrequent, affect morbidity, mortality, costs, and length of hospital stay. Vascular closure devices (VCDs) are used for rapid hemostasis and early ambulation, but there is no consensus on whether VCDs are superior to manual compression (MC). A retrospective review and nested case-control study of consecutive patients undergoing elective transfemoral coronary angiography and PCI over 3 years was performed. Hemostasis strategy was performed according to the operators' discretion. Vascular complications were defined as groin bleeding (hematoma, hemoglobin decrease ≥3 g/dl, transfusion, retroperitoneal bleeding, or arterial perforation), pseudoaneurysm, arteriovenous fistula formation, obstruction, or infection. Patients with postprocedure femoral vascular access complications were compared to randomly selected patients without complication. Data were available for 9,108 procedures, of which PCI was performed in 3,172 (34.8%). MC was performed in 2,581 (28.3%) and VCDs (4 different types) were deployed in 6,527 procedures (71.7%). Significant complications occurred in 74 procedures (0.81%), with 32 (1.24%) complications with MC and 42 (0.64%) with VCD (p = 0.004). VCD deployment failed in 80 procedures (1.23%), of which 8 (10%) had vascular complications. VCD use was a predictor of fewer complications (odds ratio 0.52, 95% confidence interval 0.33 to 0.83). In the case-control analysis, older age and use of large (7Fr to 8Fr) femoral sheaths were independent predictors of complications. In conclusion, the retrospective analysis of contemporary hemostasis strategies and outcomes in elective coronary procedures identified a low rate of complications (0.81%), with superior results after VCD deployment. Careful selection of hemostasis strategy and closure device may further decrease complication rates.