Impact of baseline renal dysfunction on cardiac outcomes and end-stage renal disease in heart failure patients with mitral regurgitation: the COAPT trial.

AIMS: Baseline renal dysfunction (RD) adversely impacts outcomes among patients with heart failure (HF) and severe secondary mitral regurgitation (MR). Heart failure and MR, in turn, accelerate progression to end-stage renal disease (ESRD), worsening prognosis. We sought to determine the impact of RD in HF patients with severe MR and the impact of transcatheter mitral valve repair (TMVr) on new-onset ESRD and the need for renal replacement therapy (RRT). METHODS AND RESULTS: The COAPT trial randomized 614 patients with HF and severe MR to MitraClip plus guideline-directed medical therapy (GDMT) vs. GDMT alone. Patients were stratified into three RD subgroups based on baseline estimated glomerular filtration rate (eGFR, mL/min/1.73 m2): none (≥60), moderate (30-60), and severe (<30). End-stage renal disease was defined as eGFR <15 mL/min/1.73 m2 or RRT. The 2-year rates of all-cause death or HF hospitalization (HFH), new-onset ESRD, and RRT according to RD and treatment were assessed. Baseline RD was present in 77.0% of patients, including 23.8% severe RD, 6.0% ESRD, and 5.2% RRT. Worse RD was associated with greater 2-year risk of death or HFH (none 45.3%; moderate 53.9%; severe 69.2%; P < 0.0001). MitraClip vs. GDMT alone improved outcomes regardless of RD (Pinteraction = 0.62) and reduced new-onset ESRD [2.9 vs. 8.1%, hazard ratio (HR) 0.34, 95% confidence interval (CI) 0.15-0.76, P = 0.008] and the need for new RRT (2.5 vs. 7.4%, HR 0.33, 95% CI 0.14-0.78, P = 0.011). CONCLUSION: Baseline RD was common in the HF patients with severe MR enrolled in COAPT and strongly predicted 2-year death and HFH. MitraClip treatment reduced new-onset ESRD and the need for RRT, contributing to the improved prognosis after TMVr.

Coronary orbital atherectomy treatment of Hispanic and Latino patients: A real-world comparative analysis.

OBJECTIVES: To assess coronary orbital atherectomy (OA) use in Hispanic or Latino (HL) patients compared to non-HL patients. BACKGROUND: HL patients are at greater risk of cardiovascular disease mortality compared with Whites with similar coronary artery calcium (CAC) scores. The safety and efficacy of coronary atherectomy in the HL patient population is unknown due to the under-representation of minorities in clinical trial research. METHODS: A retrospective analysis of consecutive patients undergoing coronary OA treatment of severely calcified lesions at the Mount Sinai Medical Center, Miami Beach, Florida (MSMCMB) was completed. From January 2014 to September 2020, a total of 609 patients from MSMCMB who underwent percutaneous coronary intervention with OA were identified in the electronic health records. RESULTS: Of those identified, 350 (57.5%) had an ethnicity classification of HL. The overall mean age was 74 years and there was a high prevalence of diabetes in the HL group compared to the non-HL group (49.7% vs. 34.7%; p = 0.0003). Severe angiographic complications were uncommon and in-hospital freedom from major adverse cardiac events (MACE), a composite of cardiac death, MI, and stroke (ischemic or hemorrhagic cerebrovascular accidents), was 98.5% overall, with no significant difference between the HL and non-HL groups, despite the higher prevalence of diabetes in the HL group. CONCLUSIONS: This study represents the largest real-world experience of OA use in HL versus non-HL patients. The main finding in this retrospective analysis is that OA can be performed safely and effectively in a high-risk population of HL patients.

Dual Antiplatelet Therapy in Patients Aged 75 Years and Older with Coronary Artery Disease: A Meta-Analysis and Systematic Review.

Objectives: This systematic review and meta-analysis evaluates the safety and efficacy of dual antiplatelet therapy (DAPT) in elderly patients with acute coronary syndrome (ACS). Background: The safety and efficacy of DAPT in elderly patients with ACS is not well characterized. Methods: We performed a systematic literature review to identify clinical studies that reported safety and efficacy outcomes after DAPT for ACS in elderly patients. The primary outcomes of primary efficacy endpoint rates and bleeding event rates were reported as random effects risk ratio (RR) with 95% confidence interval. No prior ethical approval was required since all data are public. Results: Our search yielded 660 potential studies. We included 8 studies reporting on 29,217 patients. There was a higher risk of bleeding event rates in elderly patients treated with prasugrel or ticagrelor when compared to clopidogrel with a risk ratio of 1.17 (95% CI 1.08 to 1.27, p < 0.05). There was no difference in primary efficacy endpoint rates between elderly patients treated with prasugrel or ticagrelor when compared to clopidogrel with a risk ratio of 0.85 (95% CI 0.68 to 1.07, p=0.17). Conclusions: This systematic review and meta-analysis suggests that DAPT with prasugrel or ticagrelor compared to clopidogrel is associated with a higher risk of bleeding events in elderly patients with ACS. There was no difference in the primary efficacy endpoints between the two treatment groups.

Direct oral anticoagulants in patients with atrial fibrillation and bioprosthetic valve replacement: A meta-analysis.

OBJECTIVES: This systematic review and meta-analysis compares direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in patients with atrial fibrillation and bioprosthetic valve replacement or repair (BVR). BACKGROUND: The optimal anticoagulation therapy for patients with atrial fibrillation and a history of bioprosthetic valve replacement or repair (BVR) is not well understood. METHODS: We performed a systematic literature review to identify clinical studies that compared anticoagulation therapies for patients with atrial fibrillation and BVR. The primary outcomes of stroke, major bleeding, and mortality were reported as random effects risk ratio (RR) with 95% confidence interval. No prior ethical approval was required since all data is public. RESULTS: Our search yielded 101 potential studies. We included six studies reporting on 1911 patients. There was a lower risk of stroke and major bleeding in patients with atrial fibrillation after BVR treated with DOACs when compared to VKAs with risk ratios of 0.44 (95% CI 0.24-0.82, p < 0.01) and 0.53 (95% CI 0.34-0.83, p < 0.01), respectively. There was no statistically significant difference in mortality between patients with atrial fibrillation after BVR treated with DOACs compared to patients treated with VKAs with a risk ratio of 1.12 (95% CI 0.73-1.74, p = 0.60). CONCLUSION: This systematic review and meta-analysis suggests that DOACs are superior to VKAs with respect to stroke and major bleeding in patients with atrial fibrillation and BVR.

In-hospital outcomes after transcatheter edge-to-edge mitral valve repair in patients with chronic kidney disease: An analysis from the 2010-2016 National inpatient sample.

OBJECTIVES: To assess the outcomes following transcatheter edge-to-edge mitral valve repair (TMVr) in patients with chronic kidney disease (CKD). BACKGROUND: Percutaneous TMVr is beneficial in high surgical risk patients with severe mitral regurgitation (MR). However, those with CKD are not well studied. METHODS: Utilizing the International Classification of Disease (ninth and tenth revision, clinical modification codes) and the Nationwide Inpatient Sample database, we identified 9,228 patients who underwent TMVr during 2010-2016, including those with no or mild CKD (group 1, n = 6,654 [72.11%]), moderate or severe CKD (group 2, n = 2,125 [23.03%]) and end-stage renal disease (ESRD) on dialysis (group 3, n = 449 [4.86%]). In-hospital clinical outcomes, length of stay and cost were assessed. RESULTS: In-hospital mortality increased numerically as CKD severity increased, but not statistically different between groups (1.8, 3.3, and 4.5% respectively in group 1, 2, and 3, p = .07). Moderate to severe CKD (group 2) was an independent predictor of acute renal failure requiring hemodialysis (ARFD) (OR: 3.51, CI: 2.33-5.28, p < .0001), the composite outcome of death, ARFD or stroke [OR: 3.15, 95% CI: 2.10-4.76, p < .0001] and extended length of stay [OR: 1.73, 95% CI: 1.24-2.42), p = .001] while ESRD (group 3) was an independent predictor of higher hospital cost [OR: 1.66, 95% CI: 1.01-2.74), p = .04] as compared with no or mild CKD (group 1). CONCLUSIONS: High surgical risk patients with severe MR commonly have associated comorbidities including CKD. TMVr outcomes appear to worsen with worsening CKD and therefore careful clinical case selection and further studies evaluating TMVr outcomes in CKD patients is warranted.

Impact of lesion preparation strategies on outcomes of left main PCI: The EXCEL trial.

OBJECTIVES: We examined outcomes according to lesion preparation strategy (LPS) in patients with left main coronary artery (LMCA) percutaneous coronary intervention (PCI) in the EXCEL trial. BACKGROUND: The optimal LPS for LMCA PCI is unclear. METHODS: We categorized LPS hierarchically (high to low) as: (a) rotational atherectomy (RA); (b) cutting or scoring balloon (CSB); (c) balloon angioplasty (BAL); and d) direct stenting (DIR). The primary endpoint was 3-year MACE; all-cause death, stroke, or myocardial infarction. RESULTS: Among 938 patients undergoing LMCA PCI, RA was performed in 6.0%, CSB 9.5%, BAL 71.3%, and DIR 13.2%. In patients treated with DIR, BAL, CSB, and RA, respectively, there was a progressive increase in SYNTAX score, LMCA complex bifurcation, trifurcation or calcification, number of stents, and total stent length. Any procedural complication occurred in 10.4% of cases overall, with the lowest rate in the DIR (7.4%) and highest in the RA group (16.1%) (ptrend  = .22). There were no significant differences in the 3-year rates of MACE (from RA to DIR: 17.9%, 20.2%, 14.5%, 14.7%; p = .50) or ischemia-driven revascularization (from RA to DIR: 16.8%, 10.8%, 12.3%, 14.2%; p = .65). The adjusted 3-year rates of MACE did not differ according to LPS. CONCLUSIONS: The comparable 3-year outcomes suggest that appropriate lesion preparation may be able to overcome the increased risks of complex LMCA lesion morphology.

Clinical Impact of Preexisting Right Bundle Branch Block after Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis.

INTRODUCTION: Transcatheter aortic valve replacement (TAVR) is now the treatment of choice for patients with severe aortic stenosis regardless of their surgical risk. Right bundle branch block (RBBB) can be a predictor for development of significant atrioventricular (AV) block after TAVR, requiring permanent pacemaker implantation (PPI). However, data related to the risk of PPI requirement with preexisting RBBB is scarce. Hence, this systematic review and meta-analysis aims to assess clinical outcomes of patients undergoing TAVR with RBBB on preexisting electrocardiogram. METHODS: We performed a systematic literature review to identify randomized and nonrandomized clinical studies that reported any clinical impact of patients undergoing TAVR with preexisting RBBB. A total of eight databases including PubMed (Medline), Embase, Cochrane Library, ACP Journal Club, Scopus, DARE, and Ovid containing articles from January 2000 to May 2020 were analyzed. RESULTS: We identified and screened 224 potential eligible publications through the databases and found 14 relevant clinical trials for a total of 15,319 participants. There was an increased 30-day pacemaker implantation rate of 38.1% in the RBBB group compared to 11.4% in the no RBBB group with a risk ratio of 3.56 (RR 3.56 (95% CI 3.21-3.93, p < 0.01)). There was an increased 30-day all-cause mortality in the RBBB group of 9.5% compared with 6.3% in the no RBBB group with an odds ratio of 1.60 (OR 1.60 (95% CI 1.14-2.25, p < 0.01)). CONCLUSION: This study indicates that patients with preexisting RBBB have higher incidence of PPI and all-cause mortality after TAVR compared with patients without RBBB. Further trials are needed to compare the clinical outcomes based on TAVR valve types and assess the benefit of PPI in patients with new-onset RBBB after TAVR.

Clinical impact of baseline chronic kidney disease in patients undergoing transcatheter or surgical aortic valve replacement.

OBJECTIVES: To assess the treatment effect of TAVR versus SAVR on clinical outcomes to 3 years in patients stratified by chronic kidney disease (CKD) by retrospectively studying patients randomized to TAVR or SAVR. BACKGROUND: The impact of CKD on mid-term outcomes of patients undergoing TAVR versus SAVR is unclear. METHODS: Patients randomized to TAVR or SAVR in the CoreValve US Pivotal High Risk Trial were retrospectively stratified by eGFR: none/mild or moderate/severe CKD. To evaluate the impact of baseline CKD in TAVR patients only, all patients undergoing an attempted TAVR implant in the US Pivotal Trial and CAS were stratified by baseline eGFR into none/mild, moderate, and severe CKD. The primary endpoint was major adverse cardiovascular and renal events (MACRE), a composite of all-cause mortality, myocardial infarction, stroke/TIA, and new requirement of dialysis. RESULTS: Moderate/severe CKD was present in 62.7% and 60.7% of high-risk patients randomized to TAVR or SAVR, respectively. Baseline characteristics were similar between TAVR and SAVR patients in both CKD subgroups, except for higher rates of diabetes and higher serum creatinine in SAVR patients. Among high-risk patients with moderate/severe CKD, TAVR provided a lower 3-year MACRE rate compared with SAVR: 42.1% vs. 51.0, P = .04. Of 3,733 extreme- and high-risk TAVR patients, 39.9% had none/mild, 53.8% moderate, and 6.4% severe CKD. Worsening baseline CKD was associated with increased 3-year MACRE rates [none/mild 51.5%, moderate 54.5%, severe 63.1%, P = .001]. CONCLUSIONS: TAVR results in lower 3-year MACRE versus SAVR in high-risk patients with moderate/severe CKD. In patients undergoing TAVR, worsening CKD increases mid-term mortality and MACRE. Randomized trials of TAVR vs. SAVR in patients with moderate-severe CKD would help elucidate the best treatment for these complex patients. TRIAL REGISTRATION: CoreValve US Pivotal Trial: NCT01240902. CoreValve Continued Access Study: NCT01531374.

Management of post-myocardial infarction ventricular septal defects: A critical assessment.

BACKGROUND: Post-myocardial infarction (MI) ventricular septal defects (PIVSD) are an uncommon but life-threatening complication of acute MI. Although surgical closure has been the standard of care, mortality, and recurrence of VSD remain high even after emergent surgery. Transcatheter VSD closure (TCC) devices have become an alternative or adjunct to surgical closure. METHODS: Online database search was performed for studies that included adults with PIVSD who underwent medical treatment (MT) alone, surgical closure (SC) (early or late), and TCC (early, late, or for post-surgical residual VSD). RESULTS: Twenty-six studies were included with a total of 737 patients who underwent either MT (N = 100), SC (early (n = 167), late (n = 100)), and TCC (early (n = 176), late (n = 115), or post-surgical residual VSD (n = 79)). The 30-day mortality among MT group was 92 ± 6.3%, among SC was 61 ± 22.5% (early 56 ± 23%, late 41 ± 30%), and for all TCC patients was 33 ± 24% (early 54 ± 32.7%, late 16 ± 26%), and TCC for post-surgical residual VSD 11 ± 34.9%. The mortality among overall SC, overall TCC and early TCC groups was significantly lower as compared with the MT (P < 0.001 for all comparisons). The overall mortality among all TCC, and late TCC groups was significantly lower when compared with the late SC (P < 0.0001, P < 0.0001, respectively). CONCLUSION: Closure of PIVSD decreases mortality as compared with MT alone and should be attempted as early as possible after diagnosis. Selection of TCC versus SC should be based on factors including complexity of the defect, availability of closure devices, expertise of the operator, and clinical condition of patient.

Treatment of Higher-Risk Patients With an Indication for Revascularization: Evolution Within the Field of Contemporary Percutaneous Coronary Intervention.

Patients with severe coronary artery disease with a clinical indication for revascularization but who are at high procedural risk because of patient comorbidities, complexity of coronary anatomy, and/or poor hemodynamics represent an understudied and potentially underserved patient population. Through advances in percutaneous interventional techniques and technologies and improvements in patient selection, current percutaneous coronary intervention may allow appropriate patients to benefit safely from revascularization procedures that might not have been offered in the past. The burgeoning interest in these procedures in some respects reflects an evolutionary step within the field of percutaneous coronary intervention. However, because of the clinical complexity of many of these patients and procedures, it is critical to develop dedicated specialists within interventional cardiology who are trained with the cognitive and technical skills to select these patients appropriately and to perform these procedures safely. Preprocedural issues such as multidisciplinary risk and treatment assessments are highly relevant to the successful treatment of these patients, and knowledge gaps and future directions to improve outcomes in this emerging area are discussed. Ultimately, an evolution of contemporary interventional cardiology is necessary to treat the increasingly higher-risk patients with whom we are confronted.

A Staged Approach of Proximal Left Anterior Descending Coronary Artery Percutaneous Intervention Followed by Minimally Invasive Valve Surgery.

BACKGROUND AND AIM OF THE STUDY: A subset of patients requiring coronary revascularization of the proximal left anterior descending coronary artery (LAD) and valve surgery may benefit from a staged approach, rather than combined median sternotomy coronary artery bypass graft (CABG) and valve surgery. METHODS: A retrospective evaluation was made of the outcomes of patients with significant proximal LAD and valvular heart disease undergoing a staged approach of percutaneous coronary intervention (PCI) followed by minimally invasive valve surgery (MIVS) at the authors' institution between February 2009 and April 2014. A Kaplan-Meier analysis was performed to estimate mid-term survival. RESULTS: A total of 68 consecutive patients (mean age 75.2 ± 8.9 years) was identified. PCI was performed for one- or two-vessel disease in 76.5% and 23.5% of the patients, respectively. Within a median of 39 days (IQR 11-62 days), 91.2% of patients underwent primary MIVS, and 8.8% underwent re-operative MIVS, of which 58 (85.3%) were single-valve and 10 (14.7%) were double-valve operations. At the time of surgery, 72.1% of the patients were receiving dual anti-platelet therapy. The 30-day mortality was 2.9%. At a mean follow up of 26 ± 16 months, 7.4% of the patients had a non-target vessel acute coronary syndrome, and the survival rate was 88.2%. CONCLUSIONS: Among a select group of patients with proximal LAD and valvular disease, a staged approach of PCI followed by MIVS can be safely performed for primary or re-operative surgery, with excellent mid-term outcomes.

Completeness of revascularization and its impact on the outcomes of a staged approach of percutaneous coronary intervention followed by minimally invasive valve surgery for patients with concomitant coronary artery and valvular heart disease.

BACKGROUND: A staged approach of percutaneous coronary intervention (PCI) followed by minimally invasive valve surgery (MIVS) is an alternative to the conventional combined coronary artery bypass and valve surgery for patients with concomitant coronary artery and valve disease. Limited data exist on degree of the completeness of revascularization achieved with this approach and its impact on outcomes. METHODS: A total of 138 patients, who underwent a staged approach between January 2009 and June 2013, were retrospectively evaluated. Coronary angiograms were reviewed by two cardiologists blinded to outcomes and were then categorized into two groups: complete or incomplete revascularization, which was defined as ≥1 major epicardial coronary arteries of at least 2.0 mm diameter with ≥70% untreated obstruction after the index PCI and before MIVS. RESULTS: Complete and incomplete revascularization was achieved in 105 (76%) and 33 (24%) patients, respectively. The patients with incomplete revascularization had a lower ejection fraction, a higher STS score, and more prior myocardial infarctions and multi-vessel coronary artery disease. There were no differences in the post-operative complications, 30-day mortality, or 3-year survival (84 vs. 83%, P = 0.68). After a median follow-up of 29 months, incompletely revascularized patients had a higher incidence of acute coronary syndrome (2.9 vs. 12.9%, P = 0.05). CONCLUSIONS: In patients undergoing a staged approach of PCI followed by MIVS, incomplete revascularization did not significantly impact the short or mid-term survival, but was associated with an increased incidence of acute coronary syndrome at follow-up. © 2015 Wiley Periodicals, Inc.

Predictors of poor outcomes after transcatheter aortic valve replacement: results from the PARTNER (Placement of Aortic Transcatheter Valve) trial.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a less invasive option for treatment of high-risk patients with severe aortic stenosis. We sought to identify patients at high risk for poor outcome after TAVR using a novel definition of outcome that integrates quality of life with mortality. METHODS AND RESULTS: Among 2137 patients who underwent TAVR in the PARTNER (Placement of Aortic Transcatheter Valve) trial or its associated continued access registry, quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire-Overall Summary Scale (KCCQ-OS; range 0-100, where a higher score equates to a better quality of life) at baseline and at 1, 6, and 12 months after TAVR. A poor 6-month outcome (defined as death, KCCQ-OS score <45, or ≥10-point decrease in KCCQ-OS score compared with baseline) occurred in 704 patients (33%). Using a split-sample design, we developed a multivariable model to identify a parsimonious set of covariates to identify patients at high risk for poor outcome. The model demonstrated moderate discrimination (c-index=0.66) and good calibration with the observed data, performed similarly in the separate validation cohort (c-index=0.64), and identified 211 patients (10% of the population) with a ≥50% likelihood of a poor outcome after TAVR. A second model that explored predictors of poor outcome at 1 year identified 1102 patients (52%) with ≥50% likelihood and 178 (8%) with ≥70% likelihood of a poor 1-year outcome after TAVR. CONCLUSIONS: Using a large, multicenter cohort, we have developed and validated predictive models that can identify patients at high risk for a poor outcome after TAVR. Although model discrimination was moderate, these models may help guide treatment choices and offer patients realistic expectations of outcomes based on their presenting characteristics. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

Renal denervation: current status and future applications.

Despite the variety of antihypertensive agents that are available, resistant hypertension remains a significant clinical problem and a substantial economic burden. Over the past several years, renal sympathetic denervation has been introduced as a potential therapeutic option for this clinical problem. It is a catheter-based procedure that is showing promising results and appears to be associated with minimal or low risk. Thus far, two completed clinical trials have demonstrated excellent safety and encouraging outcomes. A review of these trials is the focus of this article, in addition to the analysis of ongoing studies, and the possible future applications of this technique.

Orbital atherectomy safety and efficacy: A comparative analysis of ostial versus non-ostial calcified coronary lesions.

BACKGROUND: The safety and efficacy of coronary orbital atherectomy (OA) for treatment of ostial lesions are not yet fully established. We sought to evaluate (OA) treatment of severely calcified ostial and non-ostial lesions. METHODS: A retrospective analysis of subjects treated with OA for severely calcified ostial and non-ostial lesions, at the Mount Sinai Medical Center, Miami Beach, Florida (MSMCMB) from January 2014 to September 2020, was completed. Study baseline characteristics, lesion and vessel characteristics, procedural outcomes, and in-hospital major adverse cardiovascular events (MACE) were analyzed and compared. RESULTS: A total of 609 patients that underwent PCI with OA were identified. The majority of patients (81.9 %) had non-ostial lesions, while 16.6 % had ostial lesions (of which 2.8 % classified as aorto-ostial) and 1.5 % had unknown lesion anatomy. The mean age of the overall cohort was 74.0 ± 9.3 years, and 63.5 % were male. All patients received drug-eluting stent (DES) placement, and the overall freedom from MACE was 98.5 %, with no significant difference observed between the ostial and non-ostial groups. The freedom from cardiac death and MI was also similar between the two groups. There were low rates of bleeding complications and severe angiographic complications, and no persistent slow flow/no reflow was reported. CONCLUSIONS: This study demonstrated no significant differences in in-hospital MACE outcomes between patients with ostial versus non-ostial lesions, indicating that OA is a safe and effective treatment option for both lesion types, including those classified as aorto-ostial.

A meta-analysis of transcatheter closure of patent foramen ovale versus medical therapy for prevention of recurrent thromboembolic events in patients with cryptogenic cerebrovascular events.

OBJECTIVES: We sought to perform a meta-analysis of randomized controlled trials (RCTs) comparing percutaneous patent-foramen-ovale (PFO) closure with medical therapy for preventing recurrent thromboembolic events after cryptogenic stroke. BACKGROUND: Observational studies suggested that transcatheter PFO closure decreases recurrent events after cryptogenic stroke; however, three recent RCTs failed to demonstrate such benefit. METHODS: Trials were identified from the PubMed and Cochrane databases. Primary endpoint was the composite of transient ischemic attack (TIA) and ischemic cerebrovascular events (CVA). Both intention-to-treat (ITT) and as-treated analyses (AT) were performed. RESULTS: Three RCTs met inclusion criteria. The pooled data provided 2,303 patients, of which 1,150 were in the PFO closure group and 1,153 in the medical therapy group. In the ITT analysis, there were 43 events (3.7%) of the composite end point in the closure group compared with 61 events (5.3%) in the medical therapy group, with a trend in favor of the PFO closure (OR = 0.70; 95% CI, 0.47-1.05, P = 0.08). The incidences of TIA, ischemic CVA, and bleeding were not statistically different between the groups. There was a trend for the more frequent occurrence of atrial fibrillation in the PFO closure group (OR = 3.29; 95% CI, 0.86-12.60, P = 0.08). In the AT analysis, the composite end point was significantly less frequent in the PFO closure group (OR = 0.62; 95% CI, 0.41-0.94, P = 0.02). CONCLUSIONS: In this meta-analysis of contemporary RCTs, successful transcatheter closure of PFO might be more effective than medical therapy alone for the prevention of recurrent thromboembolic events.

Percutaneous Coronary Intervention and Discretionary Atherectomy in Patients with Aortic Stenosis: 2016-2019 National Inpatient Sample.

BACKGROUND: Patients with aortic stenosis (AS) usually have concomitant calcified coronary artery disease (CAD) requiring atherectomy to improve lesion compliance and odds of successful percutaneous coronary intervention (PCI). However, there is a paucity of data regarding PCI with or without atherectomy in patients with AS. METHODS: The National Inpatient Sample (NIS) database was queried from 2016 through 2019 using ICD-10 codes to identify individuals with AS who underwent PCI with or without atherectomy (Orbital Atherectomy [OA], Rotational or Laser Atherectomy [non-OA]). Temporal trends, safety, outcomes, costs, and correlates of major adverse cardiovascular events (MACE) were assessed using discharge weighted data. RESULTS: Hospitalizations of 45,420 AS patients undergoing PCI with or without atherectomy were identified and of those, 88.6 %, 2.3 %, and 9.1 % were treated with PCI-only, OA, or non-OA, respectively. There was an increase in PCIs (8855 to 10,885), atherectomy [OA (165 to 300) and non-OA (795 to 1255)], and intravascular ultrasound (IVUS) use (625 to 1000). The median cost of admission was higher in the atherectomy cohorts ($34,340.77 in OA, $32,306.2 in non-OA) as compared to the PCI-only cohort ($23,683.98). Patients tend to have decreased odds of MACE with IVUS guided atherectomy and PCI. CONCLUSIONS: This large database revealed a significant increase in PCI with or without atherectomy in AS patients from 2016 to 2019. Considering the complex comorbidities of AS patients, the overall complication rates were well distributed among the different cohorts, suggesting that IVUS guided PCI with or without atherectomy in patients with AS is feasible and safe.

Incidence, Predictors, and Outcomes Associated With Worsening Renal Function in Patients With Heart Failure and Secondary Mitral Regurgitation: The COAPT Trial.

Background The incidence and implications of worsening renal function (WRF) after mitral valve transcatheter edge-to-edge repair (TEER) in patients with heart failure (HF) are unknown. Therefore, the aim of this study was to determine the proportion of patients with HF and secondary mitral regurgitation who develop persistent WRF within 30 days following TEER, and whether this development portends a worse prognosis. Methods and Results In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial, 614 patients with HF and severe secondary mitral regurgitation were randomized to TEER with the MitraClip plus guideline-directed medical therapy (GDMT) versus GDMT alone. WRF was defined as serum creatinine increase ≥1.5× or ≥0.3 mg/dL from baseline persisting to day 30 or requiring renal replacement therapy. All-cause death and HF hospitalization rates between 30 days and 2 years were compared in patients with and without WRF. WRF at 30 days was present in 11.3% of patients (9.7% in the TEER plus GDMT group and 13.1% in the GDMT alone group; P=0.23). WRF was associated with all-cause death (hazard ratio [HR], 1.98 [95% CI, 1.3-3.03]; P=0.001) but not HF hospitalization (HR, 1.47 [ 95% CI, 0.97-2.24]; P=0.07) between 30 days and 2 years. Compared with GDMT alone, TEER reduced both death and HF hospitalization consistently in patients with and without WRF (Pinteraction=0.53 and 0.57, respectively). Conclusions Among patients with HF and severe secondary mitral regurgitation, the incidence of WRF at 30 days was not increased after TEER compared with GDMT alone. WRF was associated with greater 2-year mortality but did not attenuate the treatment benefits of TEER in reducing death and HF hospitalization compared with GDMT alone. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01626079.

Prediction of permanent pacemaker implantation after transcatheter aortic valve replacement: The role of machine learning.

BACKGROUND: Atrioventricular block requiring permanent pacemaker (PPM) implantation is an important complication of transcatheter aortic valve replacement (TAVR). Application of machine learning could potentially be used to predict pre-procedural risk for PPM. AIM: To apply machine learning to be used to predict pre-procedural risk for PPM. METHODS: A retrospective study of 1200 patients who underwent TAVR (January 2014-December 2017) was performed. 964 patients without prior PPM were included for a 30-d analysis and 657 patients without PPM requirement through 30 d were included for a 1-year analysis. After the exclusion of variables with near-zero variance or ≥ 50% missing data, 167 variables were included in the random forest gradient boosting algorithm (GBM) optimized using 5-fold cross-validations repeated 10 times. The receiver operator curve (ROC) for the GBM model and PPM risk score models were calculated to predict the risk of PPM at 30 d and 1 year. RESULTS: Of 964 patients included in the 30-d analysis without prior PPM, 19.6% required PPM post-TAVR. The mean age of patients was 80.9 ± 8.7 years. 42.1 % were female. Of 657 patients included in the 1-year analysis, the mean age of the patients was 80.7 ± 8.2. Of those, 42.6% of patients were female and 26.7% required PPM at 1-year post-TAVR. The area under ROC to predict 30-d and 1-year risk of PPM for the GBM model (0.66 and 0.72) was superior to that of the PPM risk score (0.55 and 0.54) with a P value < 0.001. CONCLUSION: The GBM model has good discrimination and calibration in identifying patients at high risk of PPM post-TAVR.

Using Artificial Intelligence in Predicting Ischemic Stroke Events After Percutaneous Coronary Intervention.

BACKGROUND: Ischemic stroke (IS) is an uncommon but severe complication in patients undergoing percutaneous coronary intervention (PCI). Despite significant morbidity and economic cost associated with post PCI IS, a validated risk prediction model is not currently available. AIMS: We aim to develop a machine learning model that predicts IS after PCI. METHODS: We analyzed data from Mayo Clinic CathPCI registry from 2003 to 2018. Baseline clinical and demographic data, electrocardiography (ECG), intra/post-procedural data, and echocardiographic variables were abstracted. A random forest (RF) machine learning model and a logistic regression (LR) model were developed. The receiver operator characteristic (ROC) analysis was used to assess model performance in predicting IS at 6-month, 1-, 2-, and 5-years post-PCI. RESULTS: A total of 17,356 patients were included in the final analysis. The mean age of this cohort was 66.9 ± 12.5 years, and 70.7% were male. Post-PCI IS was noted in 109 patients (.6%) at 6 months, 132 patients (.8%) at 1 year, 175 patients (1%) at 2 years, and 264 patients (1.5%) at 5 years. The area under the curve of the RF model was superior to the LR model in predicting ischemic stroke at 6 months, 1-, 2-, and 5-years. Periprocedural stroke was the strongest predictor of IS post discharge. CONCLUSIONS: The RF model accurately predicts short- and long-term risk of IS and outperforms logistic regression analysis in patients undergoing PCI. Patients with periprocedural stroke may benefit from aggressive management to reduce the future risk of IS.