A Regional Health System Journey from Volume to Value: Roadmap to the Recognition as a 15 Top Health System in the USA for Quality Excellence.

The 15 Top Health System program, an IBM Watson study, objectively measures health systems' performance overall on an annual basis using publicly reported data available from the Center for Medicare and Medicaid Services (CMS) and state data banks. Genesis Health System was recognized as an IBM Watson Health 15 Top Health System for two consecutive years in 2020 and 2021. A system-based approach with a "physician-lead, professionally-managed" framework, led to accomplishing the 15 Top Health System. The steps needed included adoption of the IBM Watson database to determine current status of certain key performance indicators, establishing a clinical effectiveness program and governance structure, and adopting Lean methodologies to analyze and determine appropriate interventions with long-term solution. The desire and willingness to accomplish this ambitious goal start with adoption by the Board and the administration of the health system while supplying appropriate financial and human resources that are dedicated to the success of the journey. In this manuscript, we describe the journey and steps implemented to accomplish the outcomes that led to the recognition as a 15 Top Health System for quality excellence.

Femoropopliteal Arterial Dissections Following FLEX VP and Balloon Angioplasty Versus Balloon Angioplasty Alone: Intravascular Ultrasound Assessment and Correlation With Angiographic Findings.

BACKGROUND: The Flex VP is a longitudinal micro-incision catheter approved for vessel prepping of femoropopliteal arteries and arteriovenous fistulas. In this study, we evaluated the presence of deep dissections (adventitia) using IVUS in patients undergoing Flex VP followed by angioplasty (PTA) versus PTA alone. METHODS: 17 patients (20 limbs) with femoropopliteal artery (FP) disease were prospectively and consecutively included (10 limbs received PTA followed by 10 limbs that received FLEX VP microincision catheter treatment followed by adjunctive PTA). Dissections post PTA, FLEX VP and FLEX VP+ PTA were evaluated using intravascular ultrasound (iDissection classification) and angiographically (NHLBI classification) by core laboratory. The evaluated segment of the vessel was prespecified at 10 cm at the most severe lesion location. Statistical differences were analyzed between the 2 groups at each appropriate procedural point for dissections, minimal luminal diameter (MLD), minimal luminal area (MLA), and residual stenosis. Statistical significance was determined by a p-value <0.05. RESULTS: Baseline demographics and angiographic variables were similar between the PTA vs FLEX VP + PTA groups with the exception of more males (87.5 % vs 33.3 %, p = 0.0274) and longer treated length (median 300 mm vs 150 mm, p = 0.0240) in the FLEX VP + PTA group. Lesion length, chronic total occlusions, angiographic and IVUS evaluated segment length for dissections, calcium severity and final balloon pressures and inflation duration were all similar between the 2 groups. Angiographic dissections were similar between the 2 groups but the increase in severe dissections from index to post POBA on IVUS (involving the adventitia) were significantly more for PTA when compared to FLEX VP + PTA (0 to 12 and 0 to 1 respectively, p = 0.0353). Bailout stenting was statistically similar for PTA as compared to FLEX VP + PTA per core lab evaluation (50 % vs 20 %, p = 0.3498). Minimal luminal area (MLA) gain by IVUS was similar between the 2 groups following FLEX VP + PTA vs PTA (7.4 mm2 vs 6.5 mm2, p = 0.7250). No serious major adverse events occurred in either group. CONCLUSION: Vessel prepping with the FLEX VP + PTA vs PTA yielded lower rates of adventitial dissections as seen on IVUS. The long-term outcomes of these findings remain unclear.

1-Year Outcomes of Blinded Physiological Assessment of Residual Ischemia After Successful PCI: DEFINE PCI Trial.

OBJECTIVES: The aim of this study was to identify the post-percutaneous coronary intervention (PCI) target value of instantaneous wave-free ratio (iFR) that would best discriminate clinical events at 1 year in the DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) study. BACKGROUND: The impact of residual ischemia detected by iFR post-PCI on clinical and symptom-related outcomes is unknown. METHODS: Blinded iFR pull back was performed after successful stent implantation in 500 patients. The primary endpoint was the rate of residual ischemia, defined as iFR ≤0.89, after operator-assessed angiographically successful PCI. Secondary endpoints included clinical events at 1 year and change in Seattle Angina Questionnaire angina frequency (SAQ-AF) score during follow-up. RESULTS: As reported, 24.0% of patients had residual ischemia (iFR ≤0.89) after successful PCI, with 81.6% of cases attributable to angiographically inapparent focal lesions. Post-PCI iFR ≥0.95 (present in 182 cases [39%]) was associated with a significant reduction in the composite of cardiac death, spontaneous myocardial infarction, or clinically driven target vessel revascularization compared with post-PCI iFR <0.95 (1.8% vs 5.7%; P = 0.04). Baseline SAQ-AF score was 73.3 ± 22.8. For highly symptomatic patients (baseline SAQ-AF score ≤60), SAQ-AF score increased by ≥10 points more frequently in patients with versus without post-PCI iFR ≥0.95 (100.0% vs 88.5%; P = 0.01). CONCLUSIONS: In DEFINE PCI, despite angiographically successful PCI, highly symptomatic patients at baseline without residual ischemia by post-PCI iFR had greater reductions in anginal symptoms at 1 year compared with patients with residual ischemia. Achieving post-PCI iFR ≥0.95 was also associated with improved 1-year event-free survival. (Physiologic Assessment of Coronary Stenosis Following PCI [DEFINE PCI]; NCT03084367).

Intravascular Ultrasound Assessment and Correlation With Angiographic Findings of Arterial Dissections Following Auryon Laser Atherectomy and Adjunctive Balloon Angioplasty: Results of the iDissection Auryon Laser Study.

BACKGROUND: Femoropopliteal arterial angiographic dissections with the use of the Auryon laser atherectomy system (previously the B-laser) have been infrequent and non-flow limiting. However, the pattern of these dissections (depth and arc) using intravascular ultrasound remains unknown. MATERIALS AND METHODS: We prospectively enrolled 29 patients in the iDissection Auryon study. The primary objective was to define the occurrence of new adventitial injury with intravascular ultrasound (IVUS). Secondary objectives included distal embolization and bailout stenting as judged by the operator because of 30% or more residual narrowing and/or NHLBI (National Heart, Lung, and Blood Institute) angiographic dissection C and higher. Core laboratory analysis was carried on all cases except for 1 patient (that crossed over to Jetstream atherectomy). Dissections were classified according to the iDissection classification as involving the intima (A), media (B), and adventitia (C) and ≤ 180-° arc (1) or >180-° arc (2). Overall, 22 of 29 patients had an embolic filter (per protocol). RESULTS: Median lesion and treated lengths were 100.0 and 150.0 mm, respectively. Vessel diameter by IVUS was 6.5 ± 1.5 mm. Chronic total occlusion (CTO) was present in 24.1% of cases. The arc of calcium was: no calcium in 27.6%, <90° in 13.8%, 90° to 180° in 20.7%, and >180° in 34.4%. Lesion severity was reduced to a median of 14% post laser and adjunctive percutaneous transluminal angioplasty (PTA) from a baseline of 76%. Bailout stenting occurred in 6 of 28 (21.4%) patients (3 for dissections, 2 for residual >30%, and 1 for both) and primary stenting in 1 of 28 (3.6%). By IVUS, there were 9 new dissections post laser (1 adventitial; 3≥180°) and 21 new dissections post laser and PTA (3 adventitial; 1≥180°). No distal embolization requiring treatment was seen and no macrodebris ≥2 mm was recovered in the filters. CONCLUSION: The Auryon laser atherectomy system had minimal rate of adventitial injury despite complex disease with relatively low bailout stent rate and no clinically significant macrodebris.

Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study.

OBJECTIVES: This study sought to evaluate the incidence and causes of an abnormal instantaneous wave-free ratio (iFR) after angiographically successful percutaneous coronary intervention (PCI). BACKGROUND: Impaired coronary physiology as assessed by fractional flow reserve is present in some patients after PCI and is prognostically relevant. METHODS: DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) was a multicenter, prospective, observational study in which a blinded iFR pull back was performed after angiographically successful PCI in 562 vessels in 500 patients. Inclusion criteria were angina with either multivessel or multilesion coronary artery disease with an abnormal baseline iFR. The primary endpoint of the study was the rate of residual ischemia after operator-assessed angiographically successful PCI, defined as an iFR <0.90. The causes of impaired iFR were categorized as stent related, untreated proximal or distal focal stenosis, or diffuse atherosclerosis. RESULTS: An average of 1.1 vessels per patient had abnormal baseline iFRs, with a mean value of 0.69 ± 0.22, which improved to 0.93 ± 0.07 post-PCI. Residual ischemia after angiographically successful PCI was present in 112 patients (24.0%), with a mean iFR in that population of 0.84 ± 0.06 (range 0.60 to 0.89). Among patients with impaired post-PCI iFRs, 81.6% had untreated focal stenoses that were angiographically inapparent, and 18.4% had diffuse disease. Among the focal lesions, 38.4% were located within the stent segment, while 31.5% were proximal and 30.1% were distal to the stent. Post-PCI vessel angiographic diameter stenosis was not a predictor of impaired post-procedural iFR. CONCLUSIONS: Blinded post-PCI physiological assessment detected residual ischemia in nearly 1 in 4 patients after coronary stenting despite an operator-determined angiographically successful result. Most cases of residual ischemia were due to inapparent focal lesions potentially amenable to treatment with additional PCI. (Physiologic Assessment of Coronary Stenosis Following PCI [DEFINE PCI]; NCT03084367).

Clinical Outcomes and Cost Comparisons of Stent and Non-Stent Interventions in Infrainguinal Peripheral Artery Disease: Insights From the Excellence in Peripheral Artery Disease (XLPAD) Registry.

BACKGROUND: The contemporary limb outcomes and costs of stent-based vs non-stent based strategies in endovascular revascularization of femoropopliteal (FP) peripheral artery disease (PAD) are not well understood. METHODS AND RESULTS: We present data from the ongoing United States multicenter Excellence in Peripheral Artery Disease Registry between 2006-2016 to compare stent vs non-stent treatment outcomes and associated costs in FP interventions. A total of 2910 FP interventions were performed in 2162 patients (mean age, 66 years), comprising 1339 stent based (superficial femoral artery, 93%) in 1007 patients and 1571 non-stent interventions (superficial femoral artery, 85%) in 1155 patients. A growing trend for non-stent based interventions and a declining trend in repeat revascularization rate at 1 year were observed across years of registry enrollment. Stent implantation was the prevailing strategy in treating longer FP lesions (mean length, 152 mm vs 105 mm; P<.001) and chronic total occlusions (65% vs 40%; P<.001), while stent implantation was employed less frequently when treating in-stent restenotic lesions (14% vs 20%; P<.001). Stent and non-stent interventions had similar 1-year limb outcomes in all-cause death, target-limb revascularization, target-vessel revascularization, and major or minor amputation. The average procedure costs for the stent group were significantly higher than the non-stent group ($6215 vs $4790; P<.001). CONCLUSION: There is a growing trend for non-stent FP artery interventions, with a significant decline in 1-year target-limb revascularization rates over time. One-year limb outcomes in stent-based compared to non-stent interventions are similar; however, at a significantly higher procedural cost.

Intravascular Ultrasound Assessment and Correlation With Angiographic Findings Demonstrating Femoropopliteal Arterial Dissections Post Atherectomy: Results From the iDissection Study.

BACKGROUND: Dissections occur post atherectomy of the infrainguinal arteries. We hypothesized that angiography under-estimates their presence significantly. METHODS: In this prospective pilot study, a total of 15 patients were evaluated by intravascular ultrasound (IVUS) following treatment of femoropopliteal de novo or non-stent restenosis using atherectomy. Eagle Eye Platinum ST IVUS catheters (Philips) were used in this study. Thirteen Jetstream XC atherectomy devices (Boston Scientific) and 2 investigational B-laser atherectomy devices (Eximo Medical) were used. Cine and IVUS images were obtained at baseline, after atherectomy, and after adjunctive balloon angioplasty. Angiographic and IVUS core labs analyzed the images. RESULTS: Mean age was 70.6 ± 8.0 years. Diabetes and claudication were present in 60% and 73%, respectively. Mean baseline, post-atherectomy, and post-adjunctive angioplasty stenosis severity was 71.4%, 38.1%, and 19.7%, respectively (P<.001 for both baseline vs post atherectomy and post atherectomy vs adjunctive angioplasty). Lesion length was 108.5 ± 43.1 mm. Forty-six dissections were identified on IVUS post atherectomy vs 8 dissections on angiogram (P<.01) (ratio, 5.75 to 1). Post adjunctive angioplasty, there were 39 dissections on IVUS vs 11 on angiogram (P<.01) (ratio, 3.55 to 1). Of these dissections, 13% and 30.8% were ≥180° in circumference post atherectomy and adjunctive balloon angioplasty, respectively (P=.047). Also, 39.1% and 33.3% involved the media and/or adventitia as seen on IVUS post atherectomy and adjunctive balloon angioplasty, respectively (P=.58). Longer lesions correlated with more dissections post atherectomy on IVUS (P=.03), but not on angiogram (P=.28). CONCLUSION: Dissections post atherectomy are grossly under-appreciated on angiogram when compared to IVUS. A multicenter registry correlating these findings with clinical outcomes is needed.

Assessment of Time to Hospital Encounter after an Initial Hospitalization for Heart Failure: Results from a Tertiary Medical Center.

BACKGROUND: Hospital inpatient readmissions for patients admitted initially with the primary diagnosis of heart failure (HF) can be as high as 20-25% within 30 days of discharge. This, however, does not include admissions for observations or emergency department (ED) visits within the same time frame and does not show a time-dependent hospital encounter following discharge after an index admission. We present data on time-dependent hospital encounter of HF patients discharged after an index admission for a primary diagnosis of HF. METHODS: The study recruited patients from 2 hospitals within the same health system. 500 consecutive admissions with the ICD diagnosis of HF were reviewed by inclusion and exclusion screening criteria. The 166 eligible remaining patients were tracked for post hospital discharge encounters consisting of hospital admissions, observation stays, and ED visits. Only those with a primary diagnosis of heart failure were included. Demographics were recorded on all patients. Days until hospital inpatient readmissions or hospital encounters were displayed in Kaplan-Meier plots. RESULTS: A total of 166 patients met inclusion criteria (mean age 79.3 years, males 54%). For the first 90 days following the index admission, there were a total of 287 follow-up visits (1.7 per patient), 1158 total hospitalization days (2.6 per visit, 7.0 per patient, and 8.6 per 100 days at risk), and 21 deaths (12.7%). At 30 days, 25% and 52% of patients had an inpatient readmission or a hospital encounter, respectively. The median time to inpatient readmission was 117 days and to hospital encounter was 27 days. CONCLUSION: Time-dependent excess days in acute care (unplanned inpatient admission, outpatient observation, and ED visit) rather than 30-day hospital inpatient readmission rate is a more realistic measure of the intensity of care required for HF patients after index admission.

Hospital cost impact of orbital atherectomy with angioplasty for critical limb ischemia treatment: a modeling approach.

AIM: The incremental cost of peripheral orbital atherectomy system (OAS) plus balloon angioplasty (BA) versus BA-only for critical limb ischemia was estimated. MATERIALS & METHODS: A deterministic simulation model used clinical and healthcare utilization data from the CALCIUM 360° trial and current cost data. Incremental cost of OAS + BA versus BA-only included differential utilization during the procedure and adverse-event costs at 3, 6 and 12-months. RESULTS: For every 100 procedures, incremental annual costs to the hospital were US$350,930 lower with OAS + BA compared with BA-only. Despite higher upfront costs, savings were realized due to reduced need for revascularization, amputation and end-of-life care over 6-12-month postoperative period. CONCLUSION: Atherectomy with OAS prior to BA was associated with cost savings to the hospital.

Comparative Assessment of Procedure Cost and Outcomes Between Guidewire and Crossing Device Strategies to Cross Peripheral Artery Chronic Total Occlusions.

OBJECTIVES: The aim of this study was to assess actual procedural costs and outcomes comparing wire-catheter and dedicated chronic total occlusion (CTO) device strategies to cross peripheral artery CTOs. BACKGROUND: Peripheral artery CTO interventions are frequently performed, but there are limited data on actual procedural costs and outcomes comparing wire-catheter and dedicated CTO devices. METHODS: The XLPAD (Excellence in Peripheral Artery Disease Intervention) registry (NCT01904851) was accessed to retrospectively compare cost and 30-day and 12-month outcomes of wire-catheter and crossing device strategies for treatment of infrainguinal peripheral artery CTO. RESULTS: Of all 3,234 treated lesions, 42% (n = 1,362) were CTOs in 1,006 unique patients. Wire-catheter approaches were used in 82% of CTOs, whereas dedicated CTO devices were used in 18% (p < 0.0001). CTO crossing device use was associated with significantly higher technical success (74% vs. 65%; p < 0.0001) and mean procedure cost ($7,800.09 vs. $4,973.24; p < 0.0001). Because 12-month repeat revascularization (11.3% vs. 17.2%; p = 0.02) and amputation rates (2.8% vs. 8.5%; p = 0.002) in the CTO crossing device arm were lower compared with the wire-catheter group, the net cost for an initial CTO crossing device strategy was $423.80 per procedure. CONCLUSIONS: An initial wire-catheter approach to cross a peripheral artery CTO is most frequently adopted. The use of dedicated CTO crossing devices provides significantly higher technical success and lower reintervention and amputation rates, at a net cost of $423.80 per procedure at 12 months.

Comparative Assessment of Guidewire and Microcatheter vs a Crossing Device-Based Strategy to Traverse Infrainguinal Peripheral Artery Chronic Total Occlusions.

PURPOSE: To compare success rates of a guidewire and microcatheter strategy vs the use of specialized crossing devices to traverse infrainguinal peripheral artery chronic total occlusions (CTOs). METHODS: For this analysis, data on 438 consecutive infrainguinal CTO interventions in 438 patients (mean age 63.2 years; 402 men) performed between August 2006 and May 2014 were extracted from the multicenter Excellence in Peripheral Artery Disease (XLPAD) database (ClinicalTrials.gov; identifier NCT01904851). Primary technical success constituted placement of a guidewire in the true lumen, past the distal CTO cap, with the initial crossing strategy. RESULTS: A wire-catheter strategy was used in 295 (67.4%) and a specialized CTO crossing device in 143 (32.6%) patients (p<0.001). Primary crossing technical success was higher with CTO devices (72.1% vs 51.9%, p<0.001). The primary wire-catheter arm used significantly more secondary CTO devices (28.1% vs 17.5%) and/or provisional re-entry devices (26.7% vs 4.9%) compared with the primary CTO device arm (both p<0.001). Secondary crossing technical success (defined as crossing with an alternate strategy: 67.5% vs 71.4%, p=1.000), provisional crossing technical success (defined as use of a re-entry device: 84.2% vs 87.5%, p=0.768), and procedure success (93.6% vs 90.9%, p=0.332) were similar between the wire-catheter and CTO device strategies, respectively. No differences were observed in periprocedural complications or 30-day adverse events; however, at 12 months, there was a significantly higher surgical revascularization rate in the primary wire-catheter arm (8.8% vs 2.8%, p=0.025). CONCLUSION: Infrainguinal peripheral artery CTO crossing is frequently attempted with a wire-catheter technique; however, an initial CTO crossing device approach is associated with higher primary technical success. Overall procedure success is similar with both strategies.

How to implement an office-based vein program.

Peripheral venous disease is a highly prevalent problem affecting over 25-30 million people in the United States. Office-based treatment of superficial veins for chronic venous insufficiency is a fast-growing area with a recent surge of interest by cardiologists in this field. We describe our own experience with establishing a vein clinic in a single-specialty, cardiology-based office, and provide tips and tricks on how you can start your own vein program. A program based on the mission of providing high-quality, appropriate care to patients and with knowledgeable providers and staff is of paramount importance for the reputation and growth of the clinic. Other important factors needed for success include diligent oversight by a director and/or supervisor, an efficient precertification process, prompt billing and coding, and establishing an internal database or participation in a national venous database to track outcomes and complications. Regular meetings of all clinic participants that discuss quality, outcomes, and operational issues are essential to help standardize care and meet the recently launched Intersocietal Accreditation Commission standards.

Bivalirudin: pharmacology and clinical applications.

Bivalirudin (Hirulog, Angiomax) is a specific, reversible and direct thrombin inhibitor with a predictable anticoagulant effect. It is cleared by both proteolytic cleavage and renal mechanisms, predominantly glomerular filtration. Bivalirudin inhibits both circulating thrombin and fibrin bound thrombin directly by binding to thrombin catalytic site and anion-binding exosite I in a concentration-dependent manner. Bivalirudin prolongs activated partial thromboplastin time, prothrombin time, thrombin time and activated clotting time (ACT). ACT levels with bivalirudin do not correlate with its clinical efficacy. Bivalirudin with a provisional GpIIb/IIIa inhibitor is indicated in elective contemporary percutaneous coronary intervention (PCI). In respect to combined ischemic and hemorrhagic endpoints of death, myocardial infarction, unplanned urgent revascularization and major bleeding during PCI (including subgroups of patients with renal impairment and diabetes) bivalirudin is not inferior to unfractioned heparin and planned GpIIb/IIIa inhibitors. In addition, bivalirudin has been consistently shown to have significantly less in-hospital major bleeding than heparin alone or heparin in combination with a GpIIb/IIIa inhibitor. Bivalirudin appears to be also safe and effective during PCI in patients with heparin-induced thrombocytopenia. Finally, data from PCI studies support the safety and efficacy of bivalirudin, although its direct randomized comparison with unfractionated heparin is lacking.