Mortality and resource utilization in surgical versus transcatheter repeat mitral valve replacement: A national analysis.

BACKGROUND: Transcatheter mitral valve replacement (TMVR) has garnered interest as a viable alternative to the traditional surgical mitral valve replacement (SMVR) for high-risk patients requiring redo operations. This study aims to evaluate the association of TMVR with selected clinical and financial outcomes. METHODS: Adults undergoing isolated redo mitral valve replacement were identified in the 2016-2020 Nationwide Readmissions Database and categorized into TMVR or SMVR cohorts. Various regression models were developed to assess the association between TMVR and in-hospital mortality, as well as additional secondary outcomes. Transseptal and transapical catheter-based approaches were also compared in relation to study endpoints. RESULTS: Of an estimated 7,725 patients, 2,941 (38.1%) underwent TMVR. During the study period, the proportion of TMVR for redo operations increased from 17.8% to 46.7% (nptrend<0.001). Following adjustment, TMVR was associated with similar odds of in-hospital mortality (AOR 0.82, p = 0.48), but lower odds of stroke (AOR 0.44, p = 0.001), prolonged ventilation (AOR 0.43, p<0.001), acute kidney injury (AOR 0.61, p<0.001), and reoperation (AOR 0.29, p = 0.02). TMVR was additionally correlated with shorter postoperative length of stay (pLOS; ß -0.98, p<0.001) and reduced costs (ß -$10,100, p = 0.002). Additional analysis demonstrated that the transseptal approach had lower adjusted mortality (AOR 0.44, p = 0.02), shorter adjusted pLOS (ß -0.43, p<0.001), but higher overall costs (ß $5,200, p = 0.04), compared to transapical. CONCLUSIONS: In this retrospective cohort study, we noted TMVR to yield similar odds of in-hospital mortality as SMVR, but fewer complications and reduced healthcare expenditures. Moreover, transseptal approaches were associated with lower adjusted mortality, shorter pLOS, but higher cost, relative to the transapical. Our findings suggest that TMVR represent a cost-effective and safe treatment modality for patients requiring redo mitral valve procedures. Nevertheless, future studies examining long-term outcomes associated with SMVR and TMVR in redo mitral valve operations, are needed.

Prevalence, mortality, cost, and disparities in transcatheter mitral valve repair and replacement in cancer patients: Artificial intelligence and propensity score national 5-year analysis of 7495 procedures.

INTRODUCTION: We conducted the first comprehensive evaluation of the therapeutic value and safety profile of transcatheter mitral edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) in individuals concurrently afflicted with cancer. METHODS: Utilizing the National Inpatient Sample (NIS) dataset, we analyzed all adult hospitalizations between 2016 and 2020 (n = 148,755,036). The inclusion criteria for this retrospectively analyzed prospective cohort study were all adult hospitalizations (age 18 years and older). Regression and machine learning analyses in addition to model optimization were conducted using ML-PSr (Machine Learning-augmented Propensity Score adjusted multivariable regression) and BAyesian Machine learning-augmented Propensity Score (BAM-PS) multivariable regression. RESULTS: Of all adult hospitalizations, there were 5790 (0.004%) TMVRs and 1705 (0.001%) TEERs. Of the total TMVRs, 160 (2.76%) were done in active cancer. Of the total TEERs, 30 (1.76%) were done in active cancer. After the comparable rates of TEER/TMVR in active cancer in 2016, the prevalence of TEER/TMVR was significantly less in active cancer from 2017 to 2020 (2.61% versus 7.28% p < 0.001). From 2017 to 2020, active cancer significantly decreased the odds of receiving TEER or TMVR (OR 0.28, 95%CI 0.13-0.68, p = 0.008). In patients with active cancer who underwent TMVR/TEER, there were no significant differences in socio-economic disparities, mortality or total hospitalization costs. CONCLUSION: The presence of malignancy does not contribute to increased mortality, length of stay or procedural costs in TMVR or TEER. Whereas the prevalence of TMVR has increased in patients with active cancer, the utilization of TEER in the context of active cancer is declining despite a growing patient population.

Differences in Treatment Patterns and Outcomes of Acute Myocardial Infarction for Low- and High-Income Patients in 6 Countries.

Importance: Differences in the organization and financing of health systems may produce more or less equitable outcomes for advantaged vs disadvantaged populations. We compared treatments and outcomes of older high- and low-income patients across 6 countries. Objective: To determine whether treatment patterns and outcomes for patients presenting with acute myocardial infarction differ for low- vs high-income individuals across 6 countries. Design, Setting, and Participants: Serial cross-sectional cohort study of all adults aged 66 years or older hospitalized with acute myocardial infarction from 2013 through 2018 in the US, Canada, England, the Netherlands, Taiwan, and Israel using population-representative administrative data. Exposures: Being in the top and bottom quintile of income within and across countries. Main Outcomes and Measures: Thirty-day and 1-year mortality; secondary outcomes included rates of cardiac catheterization and revascularization, length of stay, and readmission rates. Results: We studied 289 376 patients hospitalized with ST-segment elevation myocardial infarction (STEMI) and 843 046 hospitalized with non-STEMI (NSTEMI). Adjusted 30-day mortality generally was 1 to 3 percentage points lower for high-income patients. For instance, 30-day mortality among patients admitted with STEMI in the Netherlands was 10.2% for those with high income vs 13.1% for those with low income (difference, -2.8 percentage points [95% CI, -4.1 to -1.5]). One-year mortality differences for STEMI were even larger than 30-day mortality, with the highest difference in Israel (16.2% vs 25.3%; difference, -9.1 percentage points [95% CI, -16.7 to -1.6]). In all countries, rates of cardiac catheterization and percutaneous coronary intervention were higher among high- vs low-income populations, with absolute differences ranging from 1 to 6 percentage points (eg, 73.6% vs 67.4%; difference, 6.1 percentage points [95% CI, 1.2 to 11.0] for percutaneous intervention in England for STEMI). Rates of coronary artery bypass graft surgery for patients with STEMI in low- vs high-income strata were similar but for NSTEMI were generally 1 to 2 percentage points higher among high-income patients (eg, 12.5% vs 11.0% in the US; difference, 1.5 percentage points [95% CI, 1.3 to 1.8 ]). Thirty-day readmission rates generally also were 1 to 3 percentage points lower and hospital length of stay generally was 0.2 to 0.5 days shorter for high-income patients. Conclusions and Relevance: High-income individuals had substantially better survival and were more likely to receive lifesaving revascularization and had shorter hospital lengths of stay and fewer readmissions across almost all countries. Our results suggest that income-based disparities were present even in countries with universal health insurance and robust social safety net systems.

Cost-Effectiveness Analysis of Percutaneous Patent Foramen Ovale Closure Preventing Secondary Ischemic Stroke in Japan.

OBJECTIVES: Patent foramen ovale is a hemodynamically insignificant interatrial communication that may cause ischemic stroke. Percutaneous patent foramen ovale closure reduces the risk for recurrent ischemic stroke in patients with a history of cryptogenic ischemic stroke. This study evaluated the cost-effectiveness of patent foramen ovale closure against medical therapy in patients after their first cryptogenic ischemic stroke in Japan. MATERIALS AND METHODS: The cost-effectiveness of patent foramen ovale closure compared with medical therapy was evaluated using the Markov model. The target patients started with patent foramen ovale closure or medical therapy for preventing secondary ischemic stroke under a stable state. Quality-adjusted life year was used as the outcome of effectiveness, and the analysis was conducted with a discount rate of 2% applied to both cost and effectiveness. The results of a multicenter open-label randomized controlled trial (RESPECT trial) evaluating patent foramen ovale closure using the Amplatzer™ PFO Occluder were used as clinical evidence. Cost-effectiveness was evaluated using the incremental cost-effectiveness ratio. It was evaluated as cost-effective if it was lower than 5 million JPY/ quality-adjusted life year. RESULTS: Patent foramen ovale closure was dominant over medical therapy by 2.53 quality-adjusted life years and an estimated cost reduction of 2,353,926 JPY. The probability of patent foramen ovale closure being dominant was 82.9%. CONCLUSIONS: Patent foramen ovale closure was dominant over medical therapy for preventing secondary ischemic stroke in patients with cryptogenic ischemic stroke.

Economic assessment of traditional surgical valve replacement versus use of transfemoral intervention in degenerative aortic stenosis.

INTRODUCTION: The aim of this study was to provide an economic assessment of interventional vs. surgical aortic valve replacement in the context of cost-effectiveness. Aortic stenosis represents the most common form of degenerative valvular heart diseases. As life expectancy increases, an even emerging prevalence is expected. Over decades, surgical replacement was considered as the method of choice. Up to one third of the patients were not eligible for surgery, as their estimated peri-operative risk was too high. In the early 2000s a catheter-based technique has been developed, being an alternative treatment option for patients, considered to be inoperable. EVIDENCE ACQUISITION: A systematic analysis of current literature was performed from September 2018 to December 2018. All suitable data in the field was obtained from Pubmed and Google/Google scholar. The search terms "TAVI AND costs," "TAVR and costs" and "aortic valve replacement AND costs" was entered in the search field, showing an overall amount of 317 publications. In a next step all obtained publications were screened by expert hand selection. EVIDENCE SYNTHESIS: Recently the Food and Drug Association (FDA) approved transcatheter aortic valve replacement (TAVR) in the low-risk setting. Nevertheless, concerns on the higher price remain. We performed an analysis of current literature on aortic stenosis and economic aspects. Out of 322 screened publications, 7 studies were found eligible by expert hand selection. Based on the predefined payment readiness of the analyzed healthcare system, TAVR appeared to have a slightly better cost effectiveness. Initial results within the early era seemed to be inconsistent. Recent publications showed, TAVR might be of more cost effectiveness when using the newest generation devices and a profound clinical experience is guaranteed. CONCLUSIONS: We assume, that TAVR will not only be the method of choice for the treatment of aortic stenosis in many patients. As the valves are getting cheaper, TAVR might even be superior to conventional heart surgery from an economic point of view.

Logistical, Financial, and Psychological Impact of the COVID-19 Pandemic on Cardiac Catheterization Lab Nurses and Technologists: A U.S. National Survey.

OBJECTIVES: Coronavirus 2019 (COVID-19) significantly impacted cardiac care delivery in a manner that has not been previously experienced in the United States. Attention and resources have focused on physicians, patients, and healthcare systems with little information regarding the effects on nurses and technologists in the cardiac catheterization laboratory (CCL). METHODS: A national, online survey was conducted for nurses and technologists working in the CCL in the United States. The survey was self administered, anonymous, and included 45 questions assessing baseline demographics, logistical changes to workflow and responsibilities, staff preparedness, and mental health. RESULTS: A total of 450 respondents completed the survey, including 283 nurses (63%) and 167 technologists (37%). A total of 349 (78%) were female and mean age range was 41-50 years. Responses indicated that 68% were the primary financial provider for their families, and 74% experienced >75% decrease in case volume despite a low inpatient COVID-19 census (54% of respondents with census <10%). There were high rates of direct care for COVID-19 patients (47%), relocation (45%), lay-off/furloughs of part-time or per diem staff (42%), lay-offs of full-time staff (12%), and decreased work hours (65%). A total of 95% expressed decreased morale with an increase in mental distress, including depression (36%). Predictors of depression included relocation status, staff preparedness, and work hours. CONCLUSION: Logistical changes to CCL staffing resulted in relocation, lay-offs, furloughs, and diminished work hours, with financial and emotional ramifications. Particular attention should be paid to those in large urban hospitals, those at risk for relocation, layoffs, and furloughs, and when preparedness and administrative communication is perceived as poor.

The role of device closure of patent foramen ovale in patients with cryptogenic stroke.

One of the most frequent causes of cardiac embolism in cryptogenic stroke is a paradoxical embolus, which originate from systemic venous source though an unidentified patent foramen ovale (PFO). PFO is a common finding in the general population with a prevalence of 25% to 30%. Transcatheter PFO device closure is known to be feasible and safety treatment for such patients. In recent years, several randomized controlled trials (RCTs) have been conducted to address the superiority of PFO closure over medical therapy alone in the prevention of stroke recurrence in patients with PFO. In contrast to findings from early 3 RCTs, recent 4 RCTs could successfully show the benefits of PFO device closure compared with medical therapy, with less peri- and postprocedural complication. Based on these data, PFO device closure is recommended to carefully select cryptogenic stroke patients aged from 18 to 65 years, with a high probability of a causal role of the PFO in stroke events. However, it is still uncertain whether PFO closure is superior to oral anticoagulants therapy in these patients. Therefore, further prospective randomized trials are needed to address the efficacy of PFO device closure to oral anticoagulants therapy.

Contemporary trend of acute kidney injury incidence and incremental costs among US patients undergoing percutaneous coronary procedures.

OBJECTIVES: To assess national trends of acute kidney injury (AKI) incidence, incremental costs, risk factors, and readmissions among patients undergoing coronary angiography (CAG) and/or percutaneous coronary intervention (PCI) during 2012-2017. BACKGROUND: AKI remains a serious complication for patients undergoing CAG/PCI. Evidence is lacking in contemporary AKI trends and its impact on hospital resource utilization. METHODS: Patients who underwent CAG/PCI procedures in 749 hospitals were identified from Premier Healthcare Database. AKI was defined by ICD-9/10 diagnosis codes (584.9/N17.9, 583.89/N14.1, 583.9/N05.9, E947.8/T50.8X5) during 7 days post index procedure. Multivariable regression models were used to adjust for confounders. RESULTS: Among 2,763,681 patients, AKI incidence increased from 6.0 to 8.4% or 14% per year in overall patients; from 18.0 to 28.4% in those with chronic kidney disease (CKD) and from 2.4 to 4.2% in those without CKD (all p < .001). Significant risk factors for AKI included older age, being uninsured, inpatient procedures, CKD, anemia, and diabetes (all p < .001). AKI was associated with higher 30-day in-hospital mortality (ORadjusted = 2.55; 95% CI: 2.40, 2.70) and readmission risk (ORadjusted = 1.52; 95% CI: 1.50, 1.55). The AKI-related incremental cost during index visit and 30-day readmissions were estimated to be $8,416 and $580 per inpatient procedure and $927 and $6,145 per outpatient procedure. Overall excess healthcare burden associated with AKI was $1.67 billion. CONCLUSIONS: AKI incidence increased significantly in this large, multifacility sample of patients undergoing CAG/PCI procedures and was associated with substantial increase in hospital costs, readmissions, and mortality. Efforts to reduce AKI risk in US healthcare system are warranted.

Transcatheter Aortic Valve Implantation in Patients With Severe, Symptomatic Aortic Valve Stenosis at Intermediate Surgical Risk: A Health Technology Assessment.

BACKGROUND: Surgical aortic valve replacement (SAVR) is the conventional treatment in patients at low or intermediate surgical risk. Transcatheter aortic valve implantation (TAVI) is a less invasive procedure, originally developed as an alternative for patients at high or prohibitive surgical risk. METHODS: We conducted a health technology assessment of TAVI versus SAVR in patients with severe, symptomatic aortic valve stenosis at intermediate surgical risk, which included an evaluation of effectiveness, safety, cost-effectiveness, budget impact, and patient preferences and values. We performed a literature search to retrieve systematic reviews and selected one that was relevant to our research question. We complemented the systematic review with a literature search to identify randomized controlled trials published after the review. Applicable, previously published cost-effectiveness analyses were available, so we did not conduct a primary economic evaluation. We analyzed the net budget impact of publicly funding TAVI in people at intermediate surgical risk in Ontario. To contextualize the potential value of TAVI for people at intermediate surgical risk, we spoke with people who had aortic valve stenosis and their families. RESULTS: We identified two randomized controlled trials; they found that in patients with severe, symptomatic aortic valve stenosis, TAVI was noninferior to SAVR with respect to the composite endpoint of all-cause mortality or disabling stroke within 2 years of follow-up (GRADE: High). However, compared with SAVR, TAVI had a higher risk of some complications and a lower risk of others. Device-related costs for TAVI (approximately $23,000) are much higher than for SAVR (approximately $6,000). Based on two published cost-effectiveness analyses conducted from the perspective of the Ontario Ministry of Health, TAVI was more expensive and, on average, more effective (i.e., it produced more quality-adjusted life-years) than SAVR. The incremental cost-effectiveness ratios showed that TAVI may be cost-effective, but the probability of TAVI being cost-effective versus SAVR was less than 60% at a willingness-to-pay value of $100,000 per quality-adjusted life-year. The net budget impact of publicly funding TAVI in Ontario would be about $2 million to $3 million each year for the next 5 years. This cost may be reduced if people receiving TAVI have a shorter hospital stay (≤ 3 days). We interviewed 13 people who had lived experience with aortic valve stenosis. People who had undergone TAVI reported reduced physical and psychological effects and a shorter recovery time. Patients and caregivers living in remote or northern regions reported lower out-of-pocket costs with TAVI because the length of hospital stay was reduced. People said that TAVI increased their quality of life in the short-term immediately after the procedure. CONCLUSIONS: In people with severe, symptomatic aortic valve stenosis at intermediate surgical risk, TAVI was similar to SAVR with respect to the composite endpoint of all-cause mortality or disabling stroke. However, the two treatments had different patterns of complications. The study authors also noted that longer follow-up is needed to assess the durability of the TAVI valve. Compared with SAVR, TAVI may provide good value for money, but publicly funding TAVI in Ontario would result in additional costs over the next 5 years. People with aortic valve stenosis who had undergone TAVI appreciated its less invasive nature and reported a substantial reduction in physical and psychological effects after the procedure, improving their quality of life.

Appropriate selection of echocardiographic guidance for transcatheter atrial septal defect closure.

Transesophageal echocardiography (TEE) under general anesthesia (GA) or intracardiac echocardiography (ICE) under sedation is usually used for echocardiographic guidance during transcatheter atrial septal defect (ASD) closure. However, appropriate selection of guidance has not been fully established. Our study aimed to evaluate whether selection of guidance depending on anatomic ASD features and TEE tolerability under sedation contributes to procedure success. On the basis of anatomic ASD characteristics and TEE tolerability under sedation during the pre-procedural TEE, we selected either TEE, ICE, or combined TEE and ICE under moderate-to-deep sedation or TEE under GA for guidance. Anatomic characteristics of the defect, medical costs, complications, and primary outcomes for these four different types of guidance were analyzed. A total of 154 patients were classified into four guidance groups depending on the results of diagnostic TEE under sedation; 11 patients were scheduled for the procedure under GA in advance. Procedures were successfully completed in all but two patients in whom closure guided by TEE under sedation was attempted for an extremely large defect or extensive superior rim deficiency. Two patients who underwent TEE or combined TEE and ICE guidance under sedation were converted to ICE-only guidance due to desaturation or excessive body movement. Device dislodgement was not observed during the procedure or during median follow-up of 1188 days [interquartile range 577-1831]. Appropriate selection of guidance might contribute to successful transcatheter ASD closure.

Fractional Flow Reserve or Optical Coherence Tomography to Guide Management of Angiographically Intermediate Coronary Stenosis: A Single-Center Trial.

OBJECTIVES: The aim of this study was to compare optical coherence tomographic (OCT) guidance and fractional flow reserve (FFR) guidance in patients with angiographically intermediate coronary lesions (AICLs) in a single-center, prospective, 1:1 randomized trial. BACKGROUND: FFR and OCT imaging may help both in the assessment of AICLs and in percutaneous coronary intervention optimization. METHODS: Patients with AICLs were randomized to FFR or OCT imaging. In the FFR arm, PCI was performed if FFR was ≤0.80. In the OCT imaging arm, PCI was performed if area stenosis was ≥75% or 50% to 75% with minimal luminal area <2.5 mm2 or plaque rupture. Angina (evaluated using the Seattle Angina Questionnaire), major adverse cardiac events, and cost were assessed at the end of follow-up. The pre-defined primary endpoint was the composite of major adverse cardiac events or significant angina (defined as Seattle Angina Questionnaire frequency scale score <90) at 13 months. RESULTS: A total of 350 patients (with 446 AICLs) were enrolled (176 randomized to FFR and 174 to OCT imaging). The primary endpoint of major adverse cardiac events or significant angina at 13 months occurred in 14.8% of patients in the FFR arm and in 8.0% in the OCT imaging arm (p = 0.048). This result was driven by a statistically nonsignificant lower occurrence of all primary endpoint components. Up to 13 months, the rate of medically managed patients was significantly higher (p < 0.001) and total cost significantly lower (p < 0.001) with FFR in comparison with OCT imaging. CONCLUSIONS: In patients with AICLs, OCT guidance is associated with lower occurrence of the composite of major adverse cardiac events or significant angina. FFR guidance is associated with a higher rate of medical management and lower costs. FFR or OCT Guidance to Revascularize Intermediate Coronary Stenosis Using Angioplasty [FORZA]; NCT01824030).

The Value of Transradial: Impact on Patient Satisfaction and Health Care Economics.

This review summarizes the impact of transradial access for cardiac catheterization and percutaneous coronary intervention related to patient satisfaction, patient safety, and health care costs. In studies comparing transradial versus transfemoral approach, transradial access causes less bleeding and less vascular access site complications and provides a mortality benefit in patients with acute coronary syndromes. Transradial access improves patient satisfaction related to site tolerability by reducing pain and discomfort, and facilitating early ambulation with reduced length of stay. Taken in total, the existing randomized and observational data strongly support radial access for improved safety, patient satisfaction, and significant cost savings.

Intravascular ultrasound, optical coherence tomography, and fractional flow reserve use in acute myocardial infarction.

BACKGROUND: There are limited data on the use of intravascular ultrasound (IVUS), optical coherence tomography (OCT), and fractional flow reserve (FFR) during acute myocardial infarction (AMI). OBJECTIVES: To assess the temporal trends of IVUS, OCT, and FFR use in AMI. METHODS: A retrospective cohort study from the National Inpatient Sample (2004-2014) was designed to include AMI admissions that received coronary angiography. Administrative codes were used to identify percutaneous coronary intervention (PCI), IVUS, OCT, and FFR. Outcomes included temporal trends, inhospital mortality and resource utilization stratified by IVUS, OCT, or FFR use. RESULTS: In 4,419,973 AMI admissions, IVUS, OCT, and FFR were used in 2.6%, 0.1%, and 0.6%, respectively. There was a 22-fold, 118-fold, and 33-fold adjusted increase in IVUS, OCT, and FFR use, respectively, in 2014 compared to the first year of use. Non-ST-elevation AMI presentation, male sex, private insurance coverage, admission to a large urban hospital, and absence of cardiac arrest and cardiogenic shock were associated with higher IVUS, OCT, or FFR use. PCI was performed in 83.2% of the IVUS, OCT, or FFR cohort compared to 64.2% of the control group (p < .001). The cohort with IVUS/OCT/FFR use had lower inhospital mortality (adjusted odds ratio 0.53 [95% confidence interval 0.50-0.56]), more frequent discharges to home (83.7% vs. 76.8%), shorter hospital stays (4.3 ± 4.4 vs. 5.0 ± 5.5 days) and higher hospitalization costs ($90,683 ± 74,093 vs. $74,671 ± 75,841). CONCLUSIONS: In AMI, the use of IVUS, OCT, and FFR has increased during 2004-2014. Significant patient and hospital-level disparities exist in the use of these technologies.

Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation. BACKGROUND: Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR). METHODS: This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days. RESULTS: Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of -0.12 (95% confidence interval: -0.20 to -0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001). CONCLUSIONS: Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896).

Impact of One-Catheter Strategy with TIG I Catheter on Coronary Catheterization Performance and Economic Costs.

BACKGROUND: Coronary angiography with two catheters is the traditional strategy for diagnostic coronary procedures. TIG I catheter permits to cannulate both coronary arteries, avoiding exchanging catheters during coronary angiography by transradial access. OBJECTIVE: The aim of this study is to evaluate the impact of one-catheter strategy, by avoiding catheter exchange, on coronary catheterization performance and economic costs. METHODS: Transradial coronary diagnostic procedures conducted from January 2013 to June 2017 were collected. One-catheter strategy (TIG I catheter) and two-catheter strategy (left and right Judkins catheters) were compared. The volume of iodinated contrast administered was the primary endpoint. Secondary endpoints included radial spasm, procedural duration (fluoroscopy time) and exposure to ionizing radiation (dose-area product and air kerma). Direct economic costs were also evaluated. For statistical analyses, two-tailed p-values < 0.05 were considered statistically significant. RESULTS: From a total of 1,953 procedures in 1,829 patients, 252 procedures were assigned to one-catheter strategy and 1,701 procedures to two-catheter strategy. There were no differences in baseline characteristics between the groups. One-catheter strategy required less iodinated contrast [primary endpoint; (60-105)-mL vs. 92 (64-120)-mL; p < 0.001] than the two-catheter strategy. Also, the one-catheter group presented less radial spasm (5.2% vs. 9.3%, p = 0.022) and shorter fluoroscopy time [3.9 (2.2-8.0)-min vs. 4.8 (2.9-8.3)-min, p = 0.001] and saved costs [149 (140-160)-€/procedure vs. 171 (160-183)-€/procedure; p < 0.001]. No differences in dose-area product and air kerma were detected between the groups. CONCLUSIONS: One-catheter strategy, with TIG I catheter, improves coronary catheterization performance and reduces economic costs compared to traditional two-catheter strategy in patients referred for coronary angiography.

Pre- Versus Post-Procedure Health Care Resource Utilization in Patients Undergoing Commercial Transcatheter Mitral Valve Repair.

OBJECTIVES: The aim of this study was to assess the real-world impact of transcatheter mitral valve repair (TMVR) on hospitalizations and Medicare costs pre- versus post-TMVR. BACKGROUND: TMVR is effective in degenerative mitral regurgitation (MR) and appropriately selected patients with functional MR with high surgical risk. METHODS: Patients undergoing TMVR in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry from 2013 to 2018 were linked to Medicare claims data. Rates of hospitalizations, hospitalized days, and Medicare costs were compared 1-year pre-TMVR to 1-year post-TMVR. RESULTS: Across 246 sites, 4,970 patients with a median age of 83 years (interquartile range: 77 to 87 years) were analyzed. The TMVR indication was degenerative MR in 77.5% and functional MR in 16.7%. From pre- to post-TMVR, heart failure (HF) hospitalization rates (479 vs. 370 hospitalizations/1,000 person-years; rate ratio [RR]: 0.77) and cardiovascular hospitalizations (838 vs. 632; RR: 0.75) decreased significantly (p < 0.001 for all). Similarly, the rates of hospitalized days decreased for HF and cardiovascular causes (p < 0.05 for all). Following TMVR, the odds of having no Medicare costs for HF hospitalizations increased (69% vs. 79%; odds ratio: 1.67; p < 0.001). However, the average total Medicare costs per day alive among patients with any HF hospitalizations after TMVR increased significantly (p < 0.001). The HF hospitalization rates decreased for patients with functional MR (683 vs. 502; RR: 0.74) and those with degenerative MR (431 vs. 337; RR: 0.78) (p < 0.001). CONCLUSIONS: TMVR is associated with a decrease in cardiovascular and HF hospitalizations and a greater likelihood of having no HF Medicare costs in the year after TMVR, regardless of MR etiology. Further work is necessary to elucidate the reasons for increased costs among patients with HF hospitalizations post-TMVR.

Impact of One-Catheter Strategy with TIG I Catheter on Coronary Catheterization Performance and Economic Costs / Impacto da Estratégia de um Cateter com Cateter TIG I no Desempenho da Coronariografia por Cateterismo e Custos Econômicos

Abstract Background: Coronary angiography with two catheters is the traditional strategy for diagnostic coronary procedures. TIG I catheter permits to cannulate both coronary arteries, avoiding exchanging catheters during coronary angiography by transradial access. Objective: The aim of this study is to evaluate the impact of one-catheter strategy, by avoiding catheter exchange, on coronary catheterization performance and economic costs. Methods: Transradial coronary diagnostic procedures conducted from January 2013 to June 2017 were collected. One-catheter strategy (TIG I catheter) and two-catheter strategy (left and right Judkins catheters) were compared. The volume of iodinated contrast administered was the primary endpoint. Secondary endpoints included radial spasm, procedural duration (fluoroscopy time) and exposure to ionizing radiation (dose-area product and air kerma). Direct economic costs were also evaluated. For statistical analyses, two-tailed p-values < 0.05 were considered statistically significant. Results: From a total of 1,953 procedures in 1,829 patients, 252 procedures were assigned to one-catheter strategy and 1,701 procedures to two-catheter strategy. There were no differences in baseline characteristics between the groups. One-catheter strategy required less iodinated contrast [primary endpoint; (60-105)-mL vs. 92 (64-120)-mL; p < 0.001] than the two-catheter strategy. Also, the one-catheter group presented less radial spasm (5.2% vs. 9.3%, p = 0.022) and shorter fluoroscopy time [3.9 (2.2-8.0)-min vs. 4.8 (2.9-8.3)-min, p = 0.001] and saved costs [149 (140-160)-€/procedure vs. 171 (160-183)-€/procedure; p < 0.001]. No differences in dose-area product and air kerma were detected between the groups. Conclusions: One-catheter strategy, with TIG I catheter, improves coronary catheterization performance and reduces economic costs compared to traditional two-catheter strategy in patients referred for coronary angiography.

Resumo Fundamento: A cineangiocoronariografia com dois cateteres é a estratégia tradicional para procedimentos coronarianos de diagnóstico. O cateter TIG I permite canular ambas as artérias coronárias, evitando a troca de cateteres durante a cineangiocoronariografia por acesso transradial. Objetivo: O objetivo deste estudo é avaliar o impacto da estratégia de um cateter, evitando a troca de cateter, no desempenho da coronariografia por cateterismo e nos seus custos econômicos. Métodos: Foram coletados os procedimentos diagnósticos coronarianos transradiais realizados entre janeiro de 2013 e junho de 2017. A estratégia de um cateter (cateter TIG I) e a estratégia de dois cateteres (cateteres coronários direito e esquerdo de Judkins) foram comparadas. O volume de contraste iodado administrado foi o endpoint primário. Os endpoints secundários eram espasmo radial, duração do procedimento (tempo de fluoroscopia) e exposição a radiações ionizantes (produto dose-área e kerma no ar). Os custos econômicos diretos também foram avaliados. Para as análises estatísticas, valores de p < 0,05 bicaudais foram considerados estatisticamente significativos. Resultados: De um total de 1.953 procedimentos em 1.829 pacientes, 252 procedimentos foram atribuídos à estratégia de um cateter e 1.701 procedimentos à estratégia de dois cateteres. Não houve diferenças nas características basais entre os grupos. A estratégia de um cateter exigiu menos contraste iodado [endpoint primário; (60-105) -mL vs. 92 (64-120) -mL; p < 0,001] em comparação com a estratégia de dois cateteres. Além disso, o grupo da estratégia de um cateter apresentou menos espasmo radial (5,2% vs. 9,3%, p = 0,022) e menor tempo de fluoroscopia [3,9 (2,2-8,0) -min vs. 4,8 (2,9-8,3) -min, p = 0,001] e economia de custos [149 (140-160)-€/procedimento vs. 171 (160-183) -€/procedimento; p < 0,001]. Não foram detectadas diferenças no produto dose-área e kerma no ar entre os grupos. Conclusões: A estratégia de um cateter, com cateter TIG I, melhora o desempenho da coronariografia por cateterismo e reduz os custos econômicos em comparação com a estratégia tradicional de dois cateteres em pacientes encaminhados para cineangiocoronariografia.

Cost-Effectiveness of Transcatheter Mitral Valve Repair Versus Medical Therapy in Patients With Heart Failure and Secondary Mitral Regurgitation: Results From the COAPT Trial.

BACKGROUND: The COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) demonstrated that edge-to-edge transcatheter mitral valve repair (TMVr) with the MitraClip resulted in reduced mortality and heart failure hospitalizations and improved quality of life compared with maximally tolerated guideline-directed medical therapy (GDMT) in patients with heart failure and 3 to 4+ secondary mitral regurgitation. Whether TMVr is cost-effective compared with GDMT in this population is unknown. METHODS: We used data from the COAPT trial to perform a formal patient-level economic analysis of TMVr+GDMT versus GDMT alone for patients with heart failure and 3 to 4+ secondary mitral regurgitation from the perspective of the US healthcare system. Costs for the index TMVr hospitalization were assessed using a combination of resource-based accounting and hospital billing data (when available). Follow-up medical care costs were estimated on the basis of medical resource use collected during the COAPT trial. Health utilities were estimated for all patients at baseline and 1, 6, 12, and 24 months with the Short Form Six-Dimension Health Survey. RESULTS: Initial costs for the TMVr procedure and index hospitalization were $35 755 and $48 198, respectively. Although follow-up costs were significantly lower with TMVr compared with GDMT ($26 654 versus $38 345; P=0.018), cumulative 2-year costs remained higher with TMVr because of the upfront cost of the index procedure ($73 416 versus $38 345; P<0.001). When in-trial survival, health utilities, and costs were modeled over a lifetime horizon, TMVr was projected to increase life expectancy by 1.13 years and quality-adjusted life-years by 0.82 years at a cost of $45 648, yielding a lifetime incremental cost-effectiveness ratio of $40 361 per life-year gained and $55 600 per quality-adjusted life-year gained. CONCLUSIONS: For symptomatic patients with heart failure and 3 to 4+ secondary mitral regurgitation, TMVr increases life expectancy and quality-adjusted life expectancy compared with GDMT at an incremental cost per quality-adjusted life-year gained that represents acceptable economic value according to current US thresholds. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01626079.

Economic impact of contact force sensing in catheter ablation for atrial fibrillation.

AIMS: The TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) clinical trial compared clinical outcomes using a contact force (CF) sensing ablation catheter (TactiCath) with a catheter that lacked CF measurement. This analysis links recorded events in the TOCCASTAR study and a large claims database, IBM MarketScan®, to determine the economic impact of using CF sensing during atrial fibrillation (AF) ablation. METHODS AND RESULTS: Clinical events including repeat ablation, use of antiarrhythmic drugs, hospitalization, perforation, pericarditis, pneumothorax, pulmonary edema, pulmonary vein stenosis, tamponade, and vascular access complications were adjudicated in the year after ablation. CF was characterized as optimal if greater than or equal to 90% lesion was performed with greater than or equal to 10 g of CF. A probabilistic 1:1 linkage was created for subjects in MarketScan® with the same events in the year after ablation, and the cost was evaluated over 10 000 iterations. Of the 279 subjects in TOCCASTAR, 145 were ablated using CF (57% with optimal CF), and 134 were ablated without CF. In the MarketScan® cohort, 9811 subjects who underwent AF ablation were used to determine events and costs. For subjects ablated with optimal CF, total cost was $19 271 ± 3705 in the year after ablation. For ablation lacking CF measurement, cost was $22 673 ± 3079 (difference of $3402, P < .001). In 73% of simulations, optimal CF was associated with lower cost in the year after ablation. CONCLUSION: Compared to ablation without CF, there was a decrease in healthcare cost of $3402 per subject in the first year after the procedure when optimal CF was used.