Perioperative diltiazem therapy was not associated with improved perioperative and long-term outcomes in patients undergoing on-pump coronary artery bypass grafting.

Background: Diltiazem has been used during the perioperative period in patients undergoing coronary artery bypass grafting (CABG) to prevent arterial graft spasm. However, its long-term outcome effects remain unclear. Methods: Patient records obtained from the Society of Thoracic Surgeons and the Geisinger Clinic electronic health records between October 2008 and October 2018 were screened. Adult patients who had isolated CABG with cardiopulmonary bypass were included. Cohorts of patients who received diltiazem (DILT) and those who did not (non-DILT) were matched by propensity scores based on age, gender, surgical year, Society of Thoracic Surgeons mortality and morbidity scores, and number of arterial grafts. Incidence rate ratios (IRRs) were estimated for DILT vs non-DILT on short-term adverse outcomes. Long-term survival over time was compared between DILT vs non-DILT using Kaplan-Meier curves. Results: Among the 1004 patients included in the analyses, IRRs for the DILT group relative to the non-DILT group were: 30-day all-cause mortality, IRR: 2.33, 95% confidence interval (CI): 0.91-5.96, P=0.07; postoperative myocardial ischaemia, IRR: 1.10, 95% CI: 0.60-2.02, P=0.75; new onset atrial fibrillation, IRR: 1.06, 95% CI: 0.78-1.43, P=0.73; stroke/transient ischaemic attack, IRR: 0.76, 95% CI: 0.17-3.38, P=0.71. For long-term survival, Kaplan-Meier curves stratified by diltiazem revealed no differences in survival rates between DILT and non-DILT groups. Conclusion: For patients undergoing on-pump CABG, perioperative diltiazem therapy did not show significant short- or long-term outcome advantages over those who did not receive diltiazem.

Coronary and Structural Heart Disease Interventions During COVID-19 Pandemic: A Road Map for Clinicians and Health Care Delivery Systems.

BACKGROUND: Because of the COVID-19 pandemic, cath labs have had to modify their workflow for elective and urgent patients. METHODS: We surveyed 16 physicians across 3 hospitals in our healthcare system to address COVID-19 related concerns in the management of interventional and structural heart disease patients, and to formulate system wide criteria for deferring cases till after the pandemic. RESULTS: Our survey yielded common concerns centered on the need to protect patients, cath lab staff and physicians from unnecessary exposure to COVID-19; for COVID-19 testing prior to arrival to the cath lab; for clear communication between the referring physician and the interventionalist; but there was initial uncertainty among physicians regarding the optimal management of ST elevation myocardial infarction (STEMI; percutaneous coronary intervention versus thrombolytics). Patients with stable angina and hemodynamically stable acute coronary syndromes were deemed suitable for initial medical management, except when they had large ischemic burden. Most transcatheter aortic valve implantations (TAVI) were felt appropriate for postponement except in symptomatic patients with aortic valve area <0.5 cm2 or recent hospitalization for heart failure (HF). Most percutaneous mitral valve repair (pMVR) procedures were felt appropriate for postponement except in patients with HF. All left atrial appendage closure (LAAC) and patent foramen ovale (PFO)/atrial septal defect (ASD) closure procedures were felt appropriate for postponement. CONCLUSION: Our survey of an experienced team of clinicians yielded concise guidelines to direct the management of CAD and structural heart disease patients during the initial phases of the COVID-19 pandemic.

Efficiency, Safety, and Quality of Life After Transcatheter Aortic Valve Implantation Performed With Moderate Sedation Versus General Anesthesia.

There is growing interest in "minimalist" transcatheter aortic valve implantation (M-TAVI), performed with conscious sedation instead of general anesthesia (GA-TAVI). We assessed the impact of M-TAVI on procedural efficiency, long-term safety, and quality of life (QoL) in 477 patients with severe aortic stenosis (82 years, women 50%, STS 5.0), who underwent M-TAVI (n = 278) or GA-TAVI (n = 199). M-TAVI patients were less likely to have NYHA Class ≥3, valve-in-valve TAVI, and receive self-expanding valves. M-TAVI was completed without conversion to GA in 269 (97%) patients. M-TAVI was more efficient that GA-TAVI including shorter lengths of stay (2 vs 3 days, p <0.0001), higher likelihood of being discharged home (87% vs 72%, p <0.0001), less use of blood transfusions (10% vs 22%, p = 0.0008), inotropes (13% vs 32%, p <0.0001), contrast volume (50 vs 90 ml, p <0.0001), fluoroscopy time (20 vs 24 minute, p <0.0001), and need for >1 valves (0.4 vs 5.5%, p = 0.0004). At 1-month, death/stroke (M-TAVI vs GA-TAVI 4.0 vs 6.5%) and a "safety composite" end point (death, stroke, transient ischemic attack, myocardial infarction, new dialysis, major vascular complication, major or life-threatening bleeding, and new pacemaker: 17.6% vs 21.1%) were similar (p = NS for both). At a median follow-up of 365 days, survival curves showed similar incidence of death/stroke as well as the safety composite end point between the groups. QoL scores were similar at baseline and 1-month after TAVI. In multivariable analyses, M-TAVI showed significant improvements in all parameters of procedural efficiency. In conclusion, M-TAVI is more efficient than GA-TAVI, with similar safety at 1-month and long-term, and similar QoL scores at 1 month.

Perioperative diltiazem or nitroglycerin in on-pump coronary artery bypass: A systematic review and network meta-analysis.

BACKGROUND: Arterial graft spasm is a severe complication after coronary artery bypass graft (CABG). Among numerous potential antispasmodic agents, systemic application of diltiazem and nitroglycerin had been investigated most frequently over the past three decades. However, it remains inconclusive if either or both agents could improve patient outcomes by preventing graft spasm when applied perioperatively, and, if so, which one would be a better choice. The current systematic review and network meta-analysis aims to summarize the data from all available randomized clinical trials of perioperative continuous intravenous infusion of diltiazem and/or nitroglycerin in patients undergoing on-pump CABG in order to define and compare their roles in graft spasm prevention and their impacts on perioperative outcomes. METHODS: We searched Ovid Medline, PubMed, CINAHL, Google Scholar and Cochrane Center for randomized controlled trials that reported outcome effects of perioperative continuous intravenous infusion of diltiazem and/or nitroglycerin in patients undergoing elective on-pump CABG. Conventional meta-analyses were conducted to evaluate the pairwise comparisons (diltiazem vs. placebo; nitroglycerin vs. placebo; diltiazem vs. nitroglycerin) on perioperative outcomes. Network meta-analyses were implemented to compare the three regimens through direct and indirect comparison. RESULTS: Twenty-seven studies involving 1,660 patients were included. Pairwise and network meta-analyses found no significant difference in mortality among the groups. There are four studies that reported blood flow measurements of internal mammary artery grafts intraoperatively after dissecting or immediately after distal anastomosis while patients were on continuous intravenous infusion of diltiazem and nitroglycerin. Although insufficient for data synthesis, the measured results from all four studies suggest that both diltiazem and nitroglycerin significantly increased blood flow of arterial grafts compared to placebo. For other perioperative outcomes, compared to diltiazem, patients that received nitroglycerin had higher odds of postoperative atrial fibrillation (OR = 2.67, 95% CI: 1.15 to 6.24) and higher peak serum cardiac enzymes. Patients that received placebo had higher odds of atrial fibrillation (OR = 3.00, 95% CI: 1.18 to 7.63) and lower odds of requiring inotrope support (OR = 0.19, 95% CI: 0.04 to 0.73) compared to diltiazem. Data from the network meta-analysis indicated that diltiazem had significantly lower odds of postoperative atrial fibrillation compared to nitroglycerin (OR = 0.39, 95% CI: 0.18 to 0.85). In fact, the rank from highest to lowest rates of postoperative atrial fibrillation was placebo>nitroglycerin>diltiazem. The rank from highest to lowest odds of requiring inotropic support is nitroglycerin> diltiazem>placebo. However, placebo had significantly higher odds of postoperative myocardial infarction than diltiazem (OR = 4.51, 95% CI: 1.34 to 15.25). The rank from highest to lowest odds of postoperative myocardial infarction, transient cardiac ischemic event and atrial fibrillation is placebo>nitroglycerin>diltiazem. CONCLUSION: Compared to nitroglycerin and placebo, perioperative continuous intravenous infusion of diltiazem had stronger protective effects against postoperative ischemic cardiac injuries and atrial fibrillation although patients may need more inotropic support. The increased blood flow from diltiazem use in arterial grafts may potentially contribute to the drug's outcome benefits.

Does Preoperative Platelet Function Predict Bleeding in Patients Undergoing Off Pump Coronary Artery Bypass Surgery?

OBJECTIVE: We sought to examine the relationship between preoperative platelet function and perioperative bleeding in patients undergoing CABG. BACKGROUND: There are many ways to measure platelet aggregability. Little is known about their correlations with one another, or with bleeding. METHODS: We prospectively studied 50 patients undergoing a first isolated off-pump CABG. Thirty-four were exposed to a thienopyridine prior to surgery; 16 were not. Preoperative platelet function was measured by VerifyNow®, TEG®, AggreGuide™, Plateletworks®, vasodilator-stimulated phosphoprotein (VASP) phosphorylation, and light transmission aggregometry. Bleeding was assessed 2 ways: drop from pre- to nadir postoperative hematocrit, and chest tube drainage. Correlation coefficients were calculated using Spearman's rank-order correlation. RESULTS: Mean age was 62 years. Patient characteristics and surgical details were similar between the thienopyridine-exposed and non-exposed patients. The correlation coefficients between the 4 point-of-care platelet function measurements and hematocrit change ranged from -0.2274 to 0.2882. Only Plateletworks® correlated with drop in hematocrit (r = 0.2882, P = 0.0470). The correlation coefficients between each of the 4 point-of-care platelet function tests and the chest tube drainage were also poor, ranging from -0.3073 to 0.2272. Both AggreGuide™ (r = -0.3073, P = 0.0317) and VASP (r = -0.3187, P = 0.0272) were weakly but significantly correlated with chest tube drainage. The correlation among the 4 point-of-care platelet function measurements was poor, with coefficients ranging from -0.2504 to 0.1968. CONCLUSIONS: We observed little correlation among 4 platelet function tests, and between those assays and perioperative bleeding defined 2 different ways. Whether any of these assays should be used to guide decision making in individual patients is unclear.

Reengineering acute episodic and chronic care delivery: the Geisinger Health System experience.

Comparative effectiveness research (CER) represents an evolution in clinical decision-making research that allows for the study of heterogeneous groups of patients with complex diseases processes. It has foundations in decision science, reliability science, and health care policy research. Health care finance will increasingly rely on CER for guidance in the coming years. There is increasing awareness of the importance of decreasing unwarranted variation in health care delivery. In the past 7 years, Geisinger Health System has performed broad reengineering of its acute episodic and chronic care delivery models utilizing macrosystem-level application of CER principles. These provider-driven process initiatives have resulted in significant improvement across all segments of care delivery, improved patient outcomes, and notable cost containment. These programs have led to the creation of novel pricing models, and when "hardwired" throughout a care delivery system, they can lead to correct medical decision making by 100% of providers in all patient encounters. Neurosurgery as a specialty faces unique challenges and opportunities with respect to broad adoption and application of CER techniques.

"ProvenCareSM": a provider-driven pay-for-performance program for acute episodic cardiac surgical care.

OBJECTIVE: To test whether an integrated delivery system could successfully implement an evidence-based pay-for-performance program for coronary artery bypass graft (CABG) surgery. METHODS: The program consisted of 3 components: (1) establishing implementable best practices; (2) developing risk-based pricing; (3) establishing a mechanism for patient engagement. Surgeons reviewed all class I and IIa "2004 American Heart Association/American College of Cardiology Guidelines for CABG Surgery" and translated them into 40 verifiable behaviors. These were imbedded within a new ProvenCareSM program and "hardwired" within the electronic health record system, including order sets, templates, and "time outs". Concurrently preoperative, inpatient, and postoperative care within 90 days was packaged into a fixed price. A Patient Compact was developed to highlight the importance of patient activation. All elective CABG patients treated between February 2, 2006 and February 2, 2007 were included (ProvenCareSM Group) and compared with 137 patients treated in 2005 (Conventional Care Group). RESULTS: Initially, only 59% of patients received all 40 best practice components. At 3 months, program compliance reached 100%, but fell transiently to 86% over the next 3 months. Reliability subsequently increased to 100% and was sustained for the remainder of the study period. The overall trend in reliability was significant at P=0.001. Thirty-day clinical outcomes showed improved trends () but only the likelihood of discharge to home reached statistical significance. Length of stay decreased by 16% and mean hospital charges fell 5.2%.(Table is included in full-text article.) CONCLUSION: A provider-driven pay-for-performance process for CABG, enabled by an electronic health record system, can reliably deliver evidence-based care, fundamentally alter reimbursement incentives, and may ultimately improve outcomes and reduce resource use.