Coronary Reactivity Assessment Is Associated With Lower Health Care-Associated Costs in Patients Presenting With Angina and Nonobstructive Coronary Artery Disease.

BACKGROUND: The financial burden linked to the diagnosis and treatment of patients with chest pain on the health care system is considerable. Angina and nonobstructive coronary artery disease (ANOCA) is common, associated with adverse cardiovascular events, and may lead to repeat testing or hospitalizations. Diagnostic certainty can be achieved in patients with ANOCA using coronary reactivity testing (CRT); however, its financial effect on the patient has not been studied. Our goal was to assess the effect of CRT on health care-related cost in patients with ANOCA. METHODS: Patients with ANOCA who underwent diagnostic coronary angiography (CAG) and CRT (CRT group) were matched to controls who had similar presentation but only underwent a CAG without CRT (CAG group). Standardized inflation-adjusted costs were collected and compared between the 2 groups on an annual basis for 2 years post the index date (CRT or CAG). RESULTS: Two hundred seven CRT and 207 CAG patients were included in the study with an average age of 52.3±11.5 years and 76% females. The total cost was significantly higher in the CAG group as compared with the CRT group ($37 804 [$26 933-$48 674] versus $13 679 [$9447-$17 910]; P<0.001). When costs are itemized and divided based on the Berenson-Eggers Type of Service categorization, the largest cost difference occurred in imaging (any type, including CAG; P<0.001), procedures (eg, percutaneous coronary intervention/coronary artery bypass grafting/thrombectomy) (P=0.001), and test (eg, blood tests, EKG; P<0.001). CONCLUSIONS: In this retrospective observational study, assessment of CRT in patients with ANOCA was associated with significantly reduced annual total costs and health care utilization. Therefore, the study may support the integration of CRT into clinical practice.

Temporal Incidence and Predictors of High-Grade Atrioventricular Block After Transcatheter Aortic Valve Replacement.

Background The temporal incidence of high-grade atrioventricular block (HAVB) after transcatheter aortic valve replacement (TAVR) is uncertain. As a result, periprocedural monitoring and pacing strategies remain controversial. This study aimed to describe the temporal incidence of initial episode of HAVB stratified by pre- and post-TAVR conduction and identify predictors of delayed events. Methods and Results Consecutive patients undergoing TAVR at a single center between February 2012 and June 2019 were retrospectively assessed for HAVB within 30 days. Patients with prior aortic valve replacement, permanent pacemaker (PPM), or conversion to surgical replacement were excluded. Multivariable logistic regression was performed to assess predictors of delayed HAVB (initial event >24 hours post-TAVR). A total of 953 patients were included in this study. HAVB occurred in 153 (16.1%). After exclusion of those with prophylactic PPM placed post-TAVR, the incidence of delayed HAVB was 33/882 (3.7%). Variables independently associated with delayed HAVB included baseline first-degree atrioventricular block or right bundle-branch block, self-expanding valve, and new left bundle-branch block. Forty patients had intraprocedural transient HAVB, including 16 who developed HAVB recurrence and 6 who had PPM implantation without recurrence. PPM was placed for HAVB in 130 (13.6%) (self-expanding valve, 23.7% versus balloon-expandable valve, 11.9%; P<0.001). Eight (0.8%) patients died by 30 days, including 1 unexplained without PPM present. Conclusions Delayed HAVB occurs with higher frequency in patients with baseline first-degree atrioventricular block or right bundle-branch block, new left bundle-branch block, and self-expanding valve. These findings provide insight into optimal monitoring and pacing strategies based on periprocedural ECG findings.

Routine Continuous Electrocardiographic Monitoring Following Percutaneous Coronary Interventions.

BACKGROUND: The clinical utility of routine electrocardiographic monitoring following percutaneous coronary interventions (PCI) is not well studied. METHODS: We prospectively evaluated the incidence, cost, and the clinical implications of actionable arrhythmia alarms on telemetry monitoring following PCI. One thousand three hundred fifty-eight PCI procedures (989 [72.8%] for acute coronary syndrome and 369 [27.2%] for stable angina) on patients admitted to nonintensive care unit were identified and divided into 2 groups; group 1, patients with actionable alarms (AA) and group 2, patients with non-AA. AA included (1) ≥3 s electrical pause or asystole; (2) high-grade Mobitz type II atrioventricular block or complete heart block; (3) ventricular fibrillation; (4) ventricular tachycardia (>15 beats); (5) atrial fibrillation with rapid ventricular response; (6) supraventricular tachycardia (>15 beats). Primary outcomes were 30-day all-cause mortality. Cost-savings analysis was performed. RESULTS: Incidence of AA was 2.2% (37/1672). Time from end of procedure to AA was 5.5 (0.5, 24.5) hours. Patients with AA were older, presented with acute congestive heart failure or non-ST-segment-elevation myocardial infarction, and had multivessel or left main disease. The 30-day all-cause mortality was significantly higher in patients with AA (6.5% versus 0.3% in non-AA [P<0.001]). Applying the standardized costing approach and tailored monitoring per the American Heart Association guidelines lead to potential cost savings of $622 480.95 for the entire population. CONCLUSIONS: AA following PCI were infrequent but were associated with increase in 30-day mortality. Following American Heart Association guidelines for monitoring after PCI can lead to substantial cost saving.

Trends, Predictors, and Outcomes of Temporary Mechanical Circulatory Support for Postcardiac Surgery Cardiogenic Shock.

Postcardiac surgery cardiogenic shock (PCCS) is seen in 2% to 6% of patients who undergo cardiac surgery. There are limited large-scale data on the use of mechanical circulatory support (MCS) in these patients. This study sought to evaluate the in-hospital mortality, trends, and resource utilization for PCCS admissions with and without MCS. A retrospective cohort of PCCS between 2005 and 2014 with and without the use of temporary MCS was identified from the National Inpatient Sample. Admissions for permanent MCS and heart transplant were excluded. Propensity-matching for baseline characteristics was performed. The primary outcome was in-hospital mortality and secondary outcomes included trends in use, hospital costs and lengths of stay. In the period between 2005 and 2014, there were 132,485 admissions with PCCS, with 51.3% requiring MCS. The intra-aortic balloon pump was the predominant device used with a steady increase in other devices. MCS use for more frequent in younger patients, males and those with higher co-morbidity. There was a decrease in MCS use across all demographic categories and hospital characteristics over time. Older age, female sex, previous cardiovascular morbidity and MCS use were independently predictive of higher in-hospital mortality. In 6,830 propensity-matched pairs, PCCS admissions that required MCS use, had higher in-hospital mortality (odds ratio 2.4; p<0.001), higher hospital costs ($98,759 ± 907 vs $81,099 ± 698; p<0.001) but not a longer length of stay compared with those without MCS use. In conclusion, in patients with PCCS, this study noted a steady decrease in MCS use. Use of MCS identified PCCS patients at higher risk for in-hospital mortality and greater resource utilization.

Sex Differences in Long-Term Cause-Specific Mortality After Percutaneous Coronary Intervention: Temporal Trends and Mechanisms.

BACKGROUND: Women have higher rates of all-cause mortality after percutaneous coronary intervention. Whether this is because of greater age and comorbidity burden or a sex-specific factor remains unclear. METHODS AND RESULTS: We retrospectively assessed cause-specific long-term mortality after index percutaneous coronary intervention over 3 time periods (1991-1997, 1998-2005, and 2006-2012). Cause of death was determined using telephone interviews, medical records, and death certificates. We performed competing risks analyses of cause-specific mortality. A total of 6847 women and 16 280 men survived index percutaneous coronary intervention hospitalization 1991 to 2012. Women were older (mean±SD: 69.4±12 versus 64.8±11.7 years; P<0.001) with more comorbidities (mean±SD: Charlson index 2.1±2.1 versus 1.9±2.1; P<0.001). Across the 3 time periods, both sexes exhibited a decline in cardiac deaths at 5 years (26% relative decrease in women, 17% in men, trend P<0.001 for each). Although women had higher all-cause mortality compared with men in all eras, the excess mortality was because of noncardiac deaths. In the contemporary era, only a minority of deaths were cardiac (33.8% in women, 38.0% in men). After adjustment, there was no evidence for a sex-specific excess of risk for cardiac or noncardiac mortality. The commonest causes of death were chronic diseases and heart failure in women (5-year cumulative mortality, 5.4% and 3.9%) but cancer and myocardial infarction/sudden death in men (5.4% and 4.3%). CONCLUSIONS: The higher mortality after percutaneous coronary intervention in women is because of death from noncardiac causes. This is accounted for by baseline age and comorbidities rather than an additional sex-specific factor. These findings have implications for sex-specific clinical care and trial design.

Economic and clinical impact of routine weekend catheterization services.

OBJECTIVES: To assess the impact of weekend cardiac catheterization (cath) services for nonemergent inpatients. STUDY DESIGN: Retrospective cohort study of patients undergoing cath before and after Saturday cath service availability (CSA). METHODS: Cohorts included Friday and Saturday admissions with cath (with or without revascularization) on the subsequent Monday from January 1, 2007, to December 31, 2008 (pre-CSA events), and Friday or Saturday admissions undergoing cath the subsequent or same Saturday from January 1, 2009, to December 31, 2010 (post-CSA events). Administrative and registry data provided demographics, comorbidities, percutaneous coronary intervention (PCI) details, adverse events, hospital length of stay (LOS), and inpatient expenditures. We used generalized linear modeling to predict LOS and costs, and logistic regression to estimate the likelihood of adverse events during follow-up. RESULTS: We identified 331 pre-CSA cases (327 patients) and 244 post-CSA cases (243 patients). Cohorts were similar in age (66 years), sex (59% male), and level of comorbidity. PCI use was higher following CSA (42% vs 26%; P <.001), with procedural success accomplished in 95% and 94% of pre- and post-CSA patients, respectively. Adjusted clinical outcomes were similar (odds ratio [OR] for in-hospital mortality, 0.67 post-CSA vs pre-CSA; P = .55; OR for 30-day revascularization, 1.14; P = .68). Models predict an average LOS reduction of 1.7 days following CSA (5.7 vs 4.0 days; P <.001) yet inpatient costs were similar ($24,817 vs $24,753; 95% CI of difference, -$3611 to $3576). CONCLUSIONS: Weekend CSA for routine inpatients was clinically safe and effective, and reduced hospital LOS. Similar inpatient costs likely reflect a shift in case mix in this nonrandomized study.

Conducting pharmaceutical R&D in India - Critical components of entry strategies.

In the face of challenges associated with expiring patents, the rising cost of R&D and pressure on pricing, most major pharmaceutical companies are seeking ways to enhance productivity, reduce costs and augment the late-stage new-product pipeline. Exploiting the R&D capabilities in India is one option that can be helpful in achieving these goals. However, considering the challenges involved, important considerations must be incorporated to ensure that an appropriate R&D strategy is meticulously implemented. In creating suitable strategies, it is important to understand the historical perspective that provides insight into the relative strengths of companies in India across the R&D value chain. In addition, the ability of a company to take risks and commit to a long-term investment will largely determine the model that is selected. To implement a given model, an understanding of cultural differences and infrastructural challenges that must be overcome is extremely important. The ultimate factor that determines success or failure, however, lies within the organization. Preparing an organization by establishing appropriate structures and processes is imperative.