Tricuspid valve disease prevalence and the impact of tricuspid valve surgery on cardiovascular events and hospital resource use in medicare beneficiaries.

BACKGROUND: Tricuspid valve disease (TVD) is presumed common, however, little is known about its prevalence or the impact of tricuspid valve surgery (TVS) on healthcare resource use. METHODS: To describe the prevalence of TVD and assess the impact of TVS on resource utilization, Medicare Fee-For-Service beneficiaries from 2011 -2019 were assessed for the prevalence of non-rheumatic TVD. Hospital costs and rates of all-cause, cardiovascular (CV), and heart failure (HF) hospitalizations were compared in the 3 months pre TVS to acute (0-3 months) and chronic (3 -12 months) post TVS periods. RESULTS: Among 80.3 million beneficiaries from 2011 - 2019 Q1, over 700,000 (0.9%) had non-rheumatic TVD with 1.4% undergoing TVS. Thirty-day and 1 year mortality after TVS was 5.5% to15.5%. Compared with pre-surgery, CV and HF hospitalizations decreased from 0.12 to 0.08 per patient-month (P <.001), and 0.06 to 0.04 (P <.001) acutely. All-cause hospitalizations increased from 0.18 per patient-month to 0.23 per patient-month acutely post-surgery (P <.001), before decreasing to 0.09 per patient-month chronically (P <.001). Hospital costs increased from $2,174 per patient-month to $4,171 per patient-month acutely (P < .001), before falling to $1,441 per patient-month (P < .001) chronically. Lower costs for HF and CV hospitalization in both acute (P = .028 and P < .001, respectively) and chronic (P < .001 for both) periods were observed. CONCLUSIONS: TVS is associated with reduced CV and HF hospitalizations and associated hospital costs. Future work should determine whether transcatheter tricuspid valve repair offers similar or additional benefits.

Ten-Year Follow-Up of Mitral Valve Replacement With the Epic Porcine Valve in a Medicare Population.

BACKGROUND: Bioprosthetic surgical mitral valve replacement (SMVR) remains an important treatment option in the era of transcatheter valve interventions. This study presents 10-year clinical outcomes of Medicare beneficiaries who underwent SMVR with a contemporary low-profile mitral porcine valve. METHODS: This was a single-arm observational study using Medicare fee-for-service claims data. Deidentified patients undergoing SMVR with the Epic mitral valve (Abbott) in the United States between January 1, 2008 and December 31, 2019 were selected by International Classification of Diseases, Ninth and Tenth Revision procedure codes and then linked to a manufacturer device tracking database. All-cause mortality, heart failure (HF) rehospitalization, and mitral valve reintervention (surgical or transcatheter valve-in-valve) were evaluated at 10 years by using the Kaplan-Meier method. RESULTS: Among 75,739 Medicare beneficiaries undergoing SMVR during the study period, 14,015 received the Epic mitral valve (Abbott), 76.5% (10,720) of whom had underlying HF. The mean age was 74 ± 8 years. Survival at 10 years in patients without preoperative HF was 40.4% (95% CI, 37.4%-43.4%) compared with 25.4% (95% CI ,23.8%-27.0%) for patients with HF (P < .001). The 10-year freedom from HF rehospitalization was 51.3% (95% CI, 49.4%-53.1%). Freedom from mitral valve reintervention was 91.4% (95% CI, 89.7%-92.7%) at 10 years. CONCLUSIONS: This real-world nationwide study of Medicare beneficiaries receiving the Epic mitral valve demonstrates >90% freedom from all-cause valve reintervention and >50% freedom from HF rehospitalization at 10 years after implantation. Long-term survival and HF rehospitalization in this population with mitral valve disease treated with SMVR was found to be affected by underlying HF.

Association Between Intracoronary Imaging During PCI and Clinical Outcomes in a Real-World US Medicare Population.

Background: Use of intravascular ultrasound (IVUS) or optical coherence tomography (OCT) during percutaneous coronary intervention (PCI) is endorsed by society guidelines, but US data on real-world outcomes are lacking. Methods: Medicare claims data were identified for inpatient PCIs performed October 2015 to March 2020, with IVUS/OCT captured by ICD-10-PCS codes. Three-way propensity score matching (angio vs IVUS vs OCT) on baseline and procedural characteristics was performed. Major adverse cardiovascular events (MACE), a composite of death, myocardial infarction (MI), or repeat revascularization, was evaluated through 3 years, with a 30-day blanking window after index PCI to exclude staged procedures. Results: Of the 502,821 PCI procedures, 463,201 (92%) were guided by angiography alone, with IVUS or OCT used in 37,908 (7.5%) and 1712 (0.3%), respectively. After propensity matching, compared with angiography, the risk of major adverse cardiovascular event was similar for IVUS (hazard ratio [HR], 0.97; 95% CI, 0.91-1.03; P = .285) but lower for OCT (HR, 0.85; 95% CI, 0.77-0.94; P = .001). A similar trend was observed in clinically relevant subgroups. Compared with angiography alone, the risk of MI or repeat revascularization was lower with OCT (HR, 0.86; 95% CI, 0.76-0.97; P = .015), and the risk of MI alone was lower with IVUS (HR, 0.90; 95% CI, 0.82-0.99; P = .038). Conclusions: In a real-world US cohort, IVUS and OCT were used infrequently during PCI. Compared with angiography alone, use of intracoronary imaging during index PCI was associated with lower rates of clinical events through 3 years.

Ten-year outcomes of surgical aortic valve replacement with a contemporary supra-annular porcine valve in a Medicare population.

Objective: Bioprosthetic surgical aortic valve replacement remains an important treatment option in the era of transcatheter interventions. Real-world outcomes are not well characterized because of limited prospective follow-up studies. We present the 10-year clinical outcomes of Medicare beneficiaries undergoing surgical aortic valve replacement with a contemporary supra-annular porcine valve. Methods: This is a single-arm observational study using Medicare fee-for-service claims data. De-identified patients undergoing surgical aortic valve replacement with the Epic Supra valve (Abbott) in the United States between January 1, 2008, and December 31, 2019, were selected by International Classification of Diseases 9th and 10th Revision procedure codes and then linked to a manufacturer device tracking database. All-cause mortality, heart failure rehospitalization, and aortic valve reintervention (surgical or transcatheter valve-in-valve) were evaluated at 10 years using the Kaplan-Meier method. Results: Among 272,591 Medicare beneficiaries undergoing surgical aortic valve replacement during the study period, 11,685 received the Epic Supra valve, of whom 51.6% (6029) had underlying heart failure. Mean age was 76 ± 7 years. Survival at 10 years in patients without preoperative heart failure was 43.5% (95% confidence interval, 41.8-45.2) compared with 24.1% (95% confidence interval, 22.6-25.5) for patients with heart failure (P < .001). The 10-year freedom from heart failure rehospitalization was 64.0% (95% confidence interval, 62.6-65.3). Freedom from aortic valve reintervention was 94.6% (95% confidence interval, 93.8-95.3) at 10 years. Conclusions: This real-world nationwide study of US Medicare beneficiaries receiving the Epic Supra valve demonstrates more than 94% freedom from all-cause valve reintervention and 64% freedom from heart failure rehospitalization at 10 years postimplant. Long-term survival and heart failure rehospitalization in this population with aortic valve disease undergoing surgical aortic valve replacement were found to be impacted by underlying heart failure.

Ambulatory Pulmonary Artery Pressures After Transcatheter Edge-to-Edge Repair of the Mitral Valve in Patients With Heart Failure and Mitral Regurgitation.

The objective of this study was to assess ambulatory hemodynamics after transcatheter edge-to-edge repair (TEER) of the mitral valve. Pulmonary artery pressure (PAP) measurements from implanted sensors were collected through a remote monitoring database and linked to Medicare fee-for-service claims data. Among patients with linked data, those undergoing TEER were included if the ambulatory PAP monitor was implanted ≥3 months before TEER and ≥3 months of PAP data after TEER were available. The primary end point was diastolic PAP (dPAP) at 3 months after TEER compared with baseline. A total of 50 patients undergoing TEER between July 2014 and March 2020 were included, with an average age of 75 ± 8 years and 70% were men. dPAP was significantly lower at 3 months after TEER than baseline, -1.8 ± 4.8 mm Hg, p = 0.010. The cumulative reduction in dPAP (area under the curve) was significantly lower at 3 months after TEER, 113 ± 267 mm Hg-days, p = 0.004. A reduction in dPAP at 3 months after TEER was independently associated with a significantly lower risk of heart failure hospitalization (p = 0.023). TEER of the mitral valve is associated with a clinically relevant and sustained reduction in dPAP.

Survival Following Edge-to-Edge Transcatheter Mitral Valve Repair in Patients With Cardiogenic Shock: A Nationwide Analysis.

Background Edge-to-edge transcatheter mitral valve repair as salvage therapy in high surgical risk patients with severe mitral regurgitation presenting with cardiogenic shock (CS) has been described in small case series, but large clinical results have not been reported. This study aimed to evaluate outcomes of transcatheter mitral valve repair with MitraClip in patients with mitral regurgitation and CS using a large national database. Methods and Results From January 2014 to March 2019, we identified hospitalizations for CS in patients with mitral valve disease using data from Centers for Medicare and Medicaid Services. Those with a prior surgical or percutaneous mitral valve intervention were excluded. We compared survival between patients who underwent MitraClip during the index hospitalization and those who did not using propensity-matched analysis. The analysis included 38 166 patients (mean age, 71±11 years, 41.6% women) of whom 622 (1.6%) underwent MitraClip. MitraClip was increasingly used during CS hospitalizations over the study period (P<0.001). After matching, patients receiving MitraClip had significantly lower in-hospital mortality (odds ratio, 0.6; 95% CI, 0.47-0.77; P<0.001) and 1-year mortality (hazard ratio, 0.76; 95% CI, 0.65-0.88; P<0.001) compared with those without MitraClip. The survival benefit associated with MitraClip was consistent across subgroups of interest, with the exception of patients requiring acute mechanical circulatory support or hemodialysis at index. Conclusions In patients with mitral regurgitation presenting with CS, use of MitraClip is increasing and associated with greater in-hospital and 1-year survival. Further studies are warranted to optimize patient selection and procedure timing for those receiving MitraClip as a treatment option in CS.

Increased healthcare utilization associated with complete atrioventricular block in pacemaker patients.

PURPOSE: The purpose of the current study is to characterize and quantify the impact of complete atrioventricular block (cAVB) on heart failure hospitalization (HFH) and healthcare utilization in pacemaker (PM) patients. METHODS: Patients ≥ 18 years implanted with a dual-chamber PM from April 2008 to March 2014 were selected from the MarketScan® Commercial and Medicare Supplemental claims databases. Patients with ≤ 1-year continuous MarketScan enrollment prior to and post-implant, and those with prior HF diagnosis were excluded. Patients were dichotomized into those with cAVB, defined as a 3rd degree AVB diagnosis or AV node ablation in the year prior to PM implant, versus those without any AVB (noAVB). Post-implant HFH and associated costs were compared based on inpatient claims. RESULTS: The study cohort included 21,202 patients, of which 14,208 had no AVB and 6994 had cAVB, followed for 2.39 and 2.27 years, respectively. Patients with cAVB were associated with a significantly increased risk of cumulative HFH (HR 1.59 [95% CI 1.35-1.86] p < 0.001) and significantly higher costs ($636 [609-697] vs $369 [353-405] per pt-year, p < 0.001) compared to those with no AVB. CONCLUSIONS: Among dual-chamber PM patients without prior HF, cAVB is associated with a significantly increased risk of HFH and greater HF-related healthcare utilization. Identifying patients at high risk for HF in the setting of RV pacing, and potentially earlier use of biventricular or selective conduction system pacing, may reduce HF-related healthcare utilization.

Survival in Women Versus Men Following Implantation of Pacemakers, Defibrillators, and Cardiac Resynchronization Therapy Devices in a Large, Nationwide Cohort.

BACKGROUND: Whether outcomes differ between sexes following treatment with pacemakers (PM), implantable cardioverter defibrillators, and cardiac resynchronization therapy (CRT) devices is unclear. METHODS AND RESULTS: Consecutive US patients with newly implanted PM, implantable cardioverter defibrillators, and CRT devices from a large remote monitoring database between 2008 and 2011 were included in this observational cohort study. Sex-specific all-cause survival postimplant was compared within each device type using a multivariable Cox proportional hazards model, stratified on age and adjusted for remote monitoring utilization and ZIP-based socioeconomic variables. A total of 269 471 patients were assessed over a median 2.9 [interquartile range, 2.2, 3.6] years. Unadjusted mortality rates (MR; deaths/100 000 patient-years) were similar between women versus men receiving PMs (n=115 076, 55% male; MR 4193 versus MR 4256, respectively; adjusted hazard ratio, 0.87; 95% CI, 0.84-0.90; P<0.001) and implantable cardioverter defibrillators (n=85 014, 74% male; MR 4417 versus MR 4479, respectively; adjusted hazard ratio, 0.98; 95% CI, 0.93-1.02; P=0.244). In contrast, survival was superior in women receiving CRT defibrillators (n=61 475, 72% male; MR 5270 versus male MR 7175; adjusted hazard ratio, 0.73; 95% CI, 0.70-0.76; P<0.001) and also CRT pacemakers (n=7906, 57% male; MR 5383 versus male MR 7625, adjusted hazard ratio, 0.69; 95% CI, 0.61-0.78; P<0.001). This relative difference increased with time. These results were unaffected by age or remote monitoring utilization. CONCLUSIONS: Women accounted for less than 30% of high-voltage implants and fewer than half of low-voltage implants in a large, nation-wide cohort. Survival for women and men receiving implantable cardioverter defibrillators and PMs was similar, but dramatically greater for women receiving both defibrillator- and PM-based CRT.

Incidence and Time Course for Developing Heart Failure With High-Burden Right Ventricular Pacing.

BACKGROUND: Although right ventricular pacing can contribute to cardiomyopathy, the impact of complete atrioventricular block (cAVB) on heart failure (HF) development in pacemaker patients has not been well characterized. We evaluated the incidence and time course for developing HF after pacemaker implantation for cAVB. METHODS AND RESULTS: A MarketScan database identified patients undergoing dual-chamber pacemaker implantation from 2008 to 2014. Patients with cAVB were identified by an atrioventricular node ablation or diagnosis of third-degree AVB. Patients with ≥1 year of continuous MarketScan enrollment before and after implant and without a previous diagnosis of HF were dichotomized into those with cAVB and without AVB. The primary end point was new HF assessed over acute (0-6 months) and chronic (6 months to 4 years) phases post-pacemaker implantation. The cohort included 6994 cAVB patients and 14 208 patients without AVB, followed for 2.35 years (interquartile range, 1.62-3.39 years). After adjustment for baseline covariates, patients with cAVB experienced an increased risk of new-onset HF in the acute phase (hazard ratio, 1.62; 95% confidence interval, 1.48-1.79; P<0.001). Although the risk of HF remained elevated among those with cAVB in the chronic phase, the effect was attenuated (hazard ratio, 1.16; 95% confidence interval, 1.08-1.25; P<0.001). After pacemaker implantation, younger patients (≤55 years of age) and those with an antecedent history of atrial fibrillation experienced the highest risk of HF associated with cAVB. CONCLUSIONS: Patients with a diagnosis of cAVB, and thus presumed to have a higher burden of right ventricular pacing, experienced an increased risk of new-onset HF after pacemaker implantation compared with those without AVB. Better tools are needed to identify patients at high risk of developing HF in the setting of right ventricular pacing and to determine whether these patients benefit from upfront biventricular pacing.

Clinical Outcomes After Ablation of the AV Junction in Patients With Atrial Fibrillation: Impact of Cardiac Resynchronization Therapy.

BACKGROUND: Patients with atrial fibrillation (AF) often undergo AV junction ablation (AVJA) and pacemaker implantation. Right ventricular (RV) pacing contributes to increased risk of heart failure (HF), which may be mitigated by biventricular pacing. We sought to determine the impact of AVJA concurrent with RV versus biventricular pacemaker implantation on AF and HF hospitalizations. METHODS AND RESULTS: The MarketScan Commercial and Medicare Supplemental claims database was used to select 18- to 100-year-old patients with AF with pacemaker implantation. Patients were divided into those with an RV and a biventricular pacemaker and further into those who did (AVJA+) or did not undergo concurrent ablation. Separately, the AVJA+ group was divided into those receiving RV versus biventricular pacemakers. AF and HF hospitalization rates were compared between groups after matching on demographics, comorbidities, and baseline hospitalization rates. The study included 24 361 patients, with RV (n=23 377) or biventricular (n=984) pacemakers; 1611 patients underwent AVJA. AVJA+ was associated with reduced AF hospitalization risk (RV hazard ratio [HR], 0.31; P<0.001; biventricular HR, 0.20; P=0.003) compared with no AVJA. However, HF hospitalization risk was increased for RV (HR, 1.63; P=0.001), but not biventricular (HR, 0.98; P=0.942), pacemakers. In AVJA+ patients, biventricular pacing was associated with reduced risk of HF hospitalization versus RV pacing (HR, 0.62; P=0.017). CONCLUSIONS: In a large cohort of patients with AF, AVJA+ significantly reduced AF hospitalizations, irrespective of whether an RV or a biventricular pacemaker was implanted. However, AVJA was associated with a marked HF hospitalization increase in patients with an RV pacemaker, which was ameliorated with biventricular pacing.

Impact of remote monitoring on clinical events and associated health care utilization: A nationwide assessment.

BACKGROUND: Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) improves patient survival. However, whether RM reduces health care utilization is unknown. OBJECTIVE: The purpose of this study was to determine whether RM was associated with reduced hospitalization and costs in clinical practice. METHODS: We conducted a nationwide cohort study using the Truven Health Analytics MarketScan database. Patients implanted with a CIED between March 31, 2009, and April 1, 2012, were included. All-cause hospitalization events were compared between those using RM and those not using RM by using Cox proportional hazards methods with Andersen-Gill extension and propensity scoring. We also compared health care costs (payments >30 days after CIED implantation). RESULTS: Overall, there were 92,566 patients (mean age 72 ± 13 years; 58,140 [63%] men) with a mean follow-up of 19 ± 12 months, including 54,520 (59%) pacemaker, 27,816 (30%) implantable cardioverter-defibrillator, and 10,230 (11%) cardiac resynchronization therapy patients. Only 37% of patients (34,259) used RM. Patients with RM had Charlson Comorbidity Index values similar to those not using RM but had lower adjusted risk of all-cause hospitalization (adjusted hazard ratio 0.82; 95% confidence interval 0.80-0.84; P < .001) and shorter mean length of hospitalization (5.3 days vs 8.1 days; P < .001) during follow-up. RM was associated with a 30% reduction in hospitalization costs ($8720 mean cost per patient-year vs $12,423 mean cost per patient-year). For every 100,000 patient-years of follow-up, RM was associated with 9810 fewer hospitalizations, 119,000 fewer days in hospital, and $370,270,000 lower hospital payments. CONCLUSION: RM is associated with reductions in hospitalization and health care utilization. Since only about a third of patients with CIEDs routinely use RM, this represents a major opportunity for quality improvement.

Improved survival in patients enrolled promptly into remote monitoring following cardiac implantable electronic device implantation.

PURPOSE: Guidelines advocate remote monitoring (RM) in patients with a cardiac implantable electronic device (CIED). However, it is not known when RM should be initiated. We hypothesized that prompt initiation of RM (within 91 days of implant) is associated with improved survival compared to delayed initiation. METHODS: This retrospective, national, observational cohort study evaluated patients receiving new implants of market-released St. Jude Medical™ pacemakers (PM), implantable cardioverter defibrillators (ICD), and cardiac resynchronization therapy (CRT) devices. Patients were assigned to one of two groups: an "RM Prompt" group, in which RM was initiated within 91 days of implant; and an "RM Delayed" group, in which RM was initiated >91 days but ≤365 days of implant. The primary endpoint was all-cause mortality. RESULTS: The cohort included 106,027 patients followed for a mean of 2.6 ± 0.9 years. Overall, 47,014 (44 %) patients had a PM, 31,889 (30 %) patients had an ICD, 24,005 (23 %) patients had a CRT-D, and 3119 (3 %) patients had a CRT-P. Remote monitoring was initiated promptly (median 4 weeks [IQR 2, 8 weeks]) in 66,070 (62 %) patients; in the other 39,957 (38 %) patients, RM initiation was delayed (median 24 weeks [IQR 18, 34 weeks]). In comparison to delayed initiation, prompt initiation of RM was associated with a lower mortality rate (4023 vs. 4679 per 100,000 patient-years, p < 0.001) and greater adjusted survival (HR 1.18 [95 % CI 1.13-1.22], p < 0.001). CONCLUSIONS: Our data, for the first time, show improved survival in patients enrolled promptly into RM following CIED implantation. This advantage was observed across all CIED device types.