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.

Use of SAFARI 2™ as workhorse wire for left-sided structural heart interventions.

BACKGROUND: With the advances in percutaneous treatment technologies, the left atrial appendage occlusion (LAAO) and the transcatheter mitral valve repair using MitraClip (TMVR) are increasingly being performed today. The SAFARI 2™ guidewire is primarily used during transcatheter aortic valve implantation (TAVI), our group has also been using it during MitraClip and LAAO procedures. Our clinical study aimed to share our data on the safety and effectiveness for the use of the SAFARI 2™ guidewire during MitraClip or LAAO procedures. METHODS: This study included a total of 1730 patients (948 patients of MitraClip and 782 of LAAO). It was designed as single arm, retrospective, and multicenter between July 2016 and August 2022. SAFARI 2™ guidewire was used exclusively during all the procedures. RESULTS: A total of 1730 patients (male 55.8 %) were included in the study. There was no guidewire-related complications, stroke/transient ischemic attack, bleeding (minor/major/life-threatening), need for cardiac surgery, pneumonia, and vascular dissection/rupture in patients undergoing LAAO. There were 2 device-related pericardial effusions without tamponade. No stroke/transient ischemic attack, bleeding (minor/major/life-threatening), mortality, need for cardiac surgery, pneumonia, guidewire-related complication, pericardial effusion, vascular dissection/rupture, or clip embolization was observed in patients undergoing MitraClip. CONCLUSIONS: By taking advantage of its pre-shaped structure, the SAFARI 2™ guidewire seems to offer a reliable and safe device delivery for both MitraClip and LAAO procedures as a regular work horse wire. Our results should be confirmed by larger randomized or prospective trials.

Open Radial Artery Study.

Radial artery occlusion (RAO) has been the most common postprocedural complication of transradial artery access. The optimal method of prevention of RAO is still lacking. In our study, we aimed to evaluate the effect of patent hemostasis on early (24 hours) and late (2 weeks) RAO prevention. The Open Radial Artery Study was a single-arm, prospective, and multicenter study. The primary end points were early and late RAO at the vascular access site after transradial coronary procedures. Secondary end points were access site hematoma, pseudoaneurysm formation, arteriovenous fistula, and nerve injury. A total of 2,181 patients were analyzed (67% male, mean age 68 years). The mean interventional duration and hemostatic times were 75.6 ± 55.6 and 60 ± 5.6 minutes, respectively. Radial artery spasm occurred in 10% of patients (n = 218). Catheter kinking, radial artery rupture, or dissection were not observed during the procedure. RAO, hematoma, pseudoaneurysm, arteriovenous fistula, or nerve damage was not observed in any of the patients in the early or late period. In patients who undergo coronary diagnostic or interventional procedures through transradial artery access, the patent hemostasis method seems a critical step in the prevention of early and late RAO.

Review of intravascular lithotripsy for treating coronary, peripheral artery, and valve calcifications.

Management of intracoronary calcium (ICC) continues to be a challenge for interventional cardiologists. There have been significant advances in calcium treatment devices. However, there still exists a knowledge gap regarding which devices to choose for the treatment of ICC. The purpose of this manuscript is to review the principles of intravascular lithotripsy (IVL) and clinical data. The technique of IVL will then be compared to alternative calcium treatment devices. Clinical data will be reviewed concerning the treatment of coronary, peripheral artery and valvular calcifications. Controversies to be discussed include how to incorporate IVL into your practice, what is the best approach for treating calcium subtypes, how to approach under-expanded stents, what is the ideal technique for performing IVL, how safe is IVL, whether imaging adds value when performing IVL, and how IVL fits into a treatment program for peripheral arteries and calcified valves.

Intravascular laser lithotripsy for calcium fracture in human coronary arteries.

BACKGROUND: Electrical intravascular lithotripsy (E-IVL) uses shock waves to fracture calcified plaque. AIMS: We aimed to demonstrate the ability of laser IVL (L-IVL) to fracture calcified plaques in ex vivo human coronary arteries and to identify and evaluate the mechanisms for increased vessel compliance. METHODS: Shock waves were generated by a Ho:YAG (Holmium: yttrium-aluminium-garnet) laser (2 J, 5 Hz) and recorded by a high-speed camera and pressure sensor. Tests were conducted on phantoms and 19 fresh human coronary arteries. Before and after L-IVL, arterial compliance and optical coherence tomography (OCT) pullbacks were recorded, followed by histology. Additionally, microcomputed tomography (micro-CT) and scanning electron microscopy (SEM) were performed. Finite element models (FEM) were utilised to examine the mechanism of L-IVL. RESULTS: Phantom cracks were obtained using 230 µm and 400 µm fibres with shock-wave pressures of 84±5.0 atm and 62±0.4 atm, respectively. Post-lithotripsy, calcium plaque modifications, including fractures and debonding, were identified by OCT in 78% of the ex vivo calcified arteries (n=19). Histological analysis revealed calcium microfractures (38.7±10.4 µm width) in 57% of the arteries which were not visible by OCT. Calcium microfractures were verified by micro-CT and SEM. The lumen area increased from 2.9±0.4 to 4.3±0.8 mm2 (p<0.01). Arterial compliance increased by 2.3±0.6 atm/ml (p<0.05). FEM simulations suggest that debonding and intimal tears are additional mechanisms for increased arterial compliance. CONCLUSIONS: L-IVL has the capability to increase calcified coronary artery compliance by multiple mechanisms.

Coronary Revascularization in Patients With Cancer.

Purpose of review: The treatment of coronary artery disease (CAD) in cancer patients is an evolving landscape. Recent data emphasizes the importance of aggressive management of cardiovascular risk factors and diseases in improving cardiovascular health in this unique group of patients regardless of cancer type or stage. Recent findings: Novel cancer therapeutics such as immune therapies and proteasome inhibitors have been associated with CAD. Recent stent technologies may safely allow for shorter duration (< 6 months) of dual antiplatelet therapy post-percutaneous coronary interventions. Intracoronary imaging may be useful in the decision making process in terms of stent positioning and healing. Summary: Large registry studies have partially filled a gap left by the lack of randomized controlled trials in the treatment of CAD in cancer patients. Cardio-oncology is gaining traction as a major sub-specialty in the cardiology field given the release of the first European Society of Cardiology - Cardio-oncology guidelines in 2022.

Comparison of American and European Guidelines for the Management of Patients With Valvular Heart Disease.

This review compares the recommendations of the recent 2020 American College of Cardiology (ACC)/American Heart Association (AHA) and 2021 European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) guidelines on the management of patients with valvular heart disease (VHD). ACC/AHA and ESC/EACTS guidelines are both the updated versions of previous 2017 documents. Both guidelines fundamentally agree on the extended indications of percutaneous valve interventions, the optimal use of imaging modalities other than 2D echocardiography, the importance of a multidisciplinary Heart Team as well as active patient participation in clinical decision making, more widespread use of NOACs and earlier intervention with lower left ventricular dilatation thresholds to decrease long-term mortality. The differences between the guidelines are mainly related to the classification of the severity of valve pathologies and frequency of follow-up, level of recommendations of valve intervention indications in special patient groups such as frail patients and the left ventricular diameter and ejection fraction thresholds for intervention.

The Year in Cardio-oncology 2022.

Cardiovascular disease and cancer are the leading causes of death worldwide. With advent of novel and improved cancer therapies, a growing population of cancer patients with cardiac complications is seen. Taking this into consideration, the clinical studies have also shifted their focus from the study of a single disease to the interdisciplinary study of oncology and cardiology. This current review article provides a comprehensive review of all major articles and guidelines from the year 2021-2022 in the field of cardio-oncology.

Percutaneous coronary intervention in patients with cancer using bare metal stents compared to drug-eluting stents.

Background: Management of coronary artery disease (CAD) is unique and challenging in cancer patients. However, little is known about the outcomes of using BMS or DES in these patients. This study aimed to compare the outcomes of percutaneous coronary intervention (PCI) in cancer patients who were treated with bare metal stents (BMS) vs. drug-eluting stents (DES). Methods: We identified cancer patients who underwent PCI using BMS or DES between 2013 and 2020. Outcomes of interest were overall survival (OS) and the number of revascularizations. The Kaplan-Meier method was used to estimate the survival probability. Multivariate Cox regression models were utilized to compare OS between BMS and DES. Results: We included 346 cancer patients who underwent PCI with a median follow-up of 34.1 months (95% CI, 28.4-38.7). Among these, 42 patients were treated with BMS (12.1%) and 304 with DES (87.9%). Age and gender were similar between the BMS and DES groups (p = 0.09 and 0.93, respectively). DES use was more frequent in the white race, while black patients had more BMS (p = 0.03). The use of DES was more common in patients with NSTEMI (p = 0.03). The median survival was 46 months (95% CI, 34-66). There was no significant difference in the number of revascularizations between the BMS and DES groups (p = 0.43). There was no significant difference in OS between the BMS and DES groups in multivariate analysis (p = 0.26). In addition, independent predictors for worse survival included age > 65 years, BMI ≤ 25 g/m2, hemoglobin level ≤ 12 g/dL, and initial presentation with NSTEMI. Conclusions: In our study, several revascularizations and survival were similar between cancer patients with CAD treated with BMS and DES. This finding suggests that DES use is not associated with an increased risk for stent thrombosis, and as cancer survival improves, there may be a more significant role for DES.

Transcatheter mitral valve repair in a liver transplant candidate.

Untreated severe mitral regurgitation (MR) is associated with poor outcomes due to the adverse consequences of long-standing volume overload on the left ventricle and left atrium, which leads to pulmonary hypertension and right-sided heart failure. Early intervention results in favorable long-term outcomes making appropriate timing of intervention very critical. We present a 53-year-old male with severe symptomatic MR and right sided-heart failure which progressed to cardiac cirrhosis necessitating enrollment to the liver transplant list. Transcatheter mitral valve repair (TMVR) using MitraClip implantation resulted in impressive clinical improvement and resolution of cirrhosis. Eventually, the patient was taken off the transplant list. Treatment of severe MR may lead to improvements in congestive hepatopathy.

Superficial Femoral Artery Endovascular Therapy: 12-Month Primary Patency Rates of Contemporary Endovascular Devices from 25,051 Patients.

BACKGROUND: Approximately 5.8 million people experience peripheral arterial disease (PAD) in the United States today. Superficial femoral artery (SFA) disease is the most common cause of symptomatic PAD. New-generation nitinol stents, drug-coated stents, drug-coated balloons (DCB), covered stents, and directional or orbital atherectomy devices have shown promising results. However, clinical equipoise persists regarding the optimal selection of devices, largely attributable to the different inclusion criteria, study populations, length of lesions treated, definitions of "patency" and "restenosis," and follow-up methods in the up-to-date pivotal trials. METHODS: A prospective protocol was developed. We performed a literature search using PubMed from January 2011 to July 2021. All published articles including endovascular interventions in the SFA with reported 12-month "primary patency" rates as endpoints were included. RESULTS: We identified 25,051 patients in 124 studies reporting 12-month primary patency rates in patients with SFA disease. Primary patency rates were (weighted average) 82.6% for drug-eluting stents, 77.2% for drug-coated balloons, 75.2% for covered stents, 73.9% for nitinol self-expanding stents, 66.1% for atherectomy, and 44.5% for bare balloon angioplasty. CONCLUSION: The most frequently used endovascular devices yielded various 12-month primary patency rates ranging from 44.5% to 82.6%. The increased variation in inclusion criteria, lesion length, and complexity of lesions between studies does not allow direct comparison between the individual devices. Larger randomized trials in specific patient populations comparing these modalities are needed well before we can make proper recommendations on the superiority of one device over the other.

Primary Endovascular Treatment of Late-Onset Type 3 Endovascular Aortic Repair Rupture Using The Endurant II Stent Graft and Rapid Response Protocol.

The objective of this article is to describe a patient with hemorrhagic shock due to type 3 postendovascular aortic repair rupture successfully treated with the endurant II stent graft via a primary endovascular approach with a rapid response protocol. A 65-year-old male patient who underwent endovascular aortic repair 3 years ago was admitted to the emergency department with severe abdominal pain and hemorrhagic shock. The patient was rapidly taken to the angiography laboratory, and aortography demonstrated distal aortic graft rupture and extravasation of contrast media. The repair was performed successfully with 3 stent-grafts by paying attention to rupture localization and renal artery ostia. The hemodynamics of the patient improved very quickly, and the patient was discharged after 5 days. Emergency primary stent grafting using a rapid response protocol could be a crucial alternative to open surgery for late endoleaks, which are complicated with hemorrhagic shock.

Post-cardiac arrest PCI is underutilized among cancer patients: Machine learning augmented nationally representative case-control study of 30 million hospitalizations.

BACKGROUND: Cancer patients are less likely to undergo percutaneous coronary intervention (PCI) after cardiac arrest, although they demonstrate improved mortality benefit from the procedure. We produced the largest nationally representative analysis of mortality of cardiac arrest and PCI for patients with cancer versus non-cancer. METHODS: Propensity score adjusted multivariable regression for mortality was performed in this case-control study of the United States' largest all-payer hospitalized dataset, the 2016 National Inpatient Sample. Regression models of mortality and PCI weighted by the complex survey design were fully adjusted for age, race, income, cancer metastases, NIS-calculated mortality risk by Diagnosis Related Group (DRG), acute coronary syndrome, and likelihood of undergoing PCI. RESULTS: Of the 30,195,722 hospitalized adult patients, 15.43% had cancer, and 0.79% of the whole sample presented with cardiac arrest (of whom 20.57% underwent PCI). In fully adjusted regression analysis among patients with cardiac arrest, PCI significantly reduced mortality (OR 0.15, 95 %CI 0.13-0.19; p < 0.001) among patients with cancer greater than those without it (OR 0.21, 95 %CI 0.20-0.23; p < 0.001). CONCLUSIONS: This nationally representative study suggests that post-cardiac arrest PCI is underutilized among patients with cancer despite its significant mortality reduction for such patients (independent of clinical acuity).

Fractional Flow Reserve Cardio-Oncology Effects on Inpatient Mortality, Length of Stay, and Cost Based on Malignancy Type: Machine Learning Supported Nationally Representative Case-Control Study of 30 Million Hospitalizations.

Background and Objectives: There are no nationally representative studies of mortality and cost effectiveness for fractional flow reserve (FFR) guided percutaneous coronary interventions (PCI) in patients with cancer. Our study aims to show how this patient population may benefit from FFR-guided PCI. Materials and Methods: Propensity score matched analysis and backward propagation neural network machine learning supported multivariable regression was performed for inpatient mortality in this case-control study of the 2016 National Inpatient Sample (NIS). Regression results were adjusted for age, race, income, geographic region, metastases, mortality risk, and the likelihood of undergoing FFR versus non-FFR PCI. All analyses were adjusted for the complex survey design to produce nationally representative estimates. Results: Of the 30,195,722 hospitalized patients meeting criteria, 3.37% of the PCIs performed included FFR. In propensity score adjusted multivariable regression, FFR versus non-FFR PCI significantly reduced inpatient mortality (OR 0.47, 95%CI 0.35−0.63; p < 0.001) and length of stay (LOS) (in days; beta −0.23, 95%CI −0.37−−0.09; p = 0.001) while increasing cost (in USD; beta $5708.63, 95%CI, 3042.70−8374.57; p < 0.001), without significantly increasing complications overall. FFR versus non-FFR PCI did not specifically change cancer patients' inpatient mortality, LOS, or cost. However, FFR versus non-FFR PCI significantly increased inpatient mortality for Hodgkin's lymphoma (OR 52.48, 95%CI 7.16−384.53; p < 0.001) and rectal cancer (OR 24.38, 95%CI 2.24−265.73; p = 0.009). Conclusions: FFR-guided PCI may be safely utilized in patients with cancer as it does not significantly increase inpatient mortality, complications, and LOS. These findings support the need for an increased utilization of FFR-guided PCI and further studies to evaluate its long-term impact.

Predictors of Recurrence and Survival in Cancer Patients With Pericardial Effusion Requiring Pericardiocentesis.

Aim: This study investigated the factors predicting survival and the recurrence of pericardial effusion (PE) requiring pericardiocentesis (PCC) in patients with cancer. Materials and Methods: We analyzed the data of patients who underwent PCC for large PEs from 2010 to 2020 at The University of Texas MD Anderson Cancer Center. The time to the first recurrent PE requiring PCC was the interval from the index PCC with pericardial drain placement to first recurrent PE requiring drainage (either repeated PCC or a pericardial window). Univariate and multivariate Fine-Gray models accounting for the competing risk of death were used to identify predictors of recurrent PE requiring drainage. Cox regression models were used to identify predictors of death. Results: The study cohort included 418 patients with index PCC and pericardial drain placement, of whom 65 (16%) had recurrent PEs requiring drainage. The cumulative incidences of recurrent PE requiring drainage at 12 and 60 months were 15.0% and 15.6%, respectively. Younger age, anti-inflammatory medication use, and solid tumors were associated with an increased risk of recurrence of PE requiring drainage, and that echocardiographic evidence of tamponade at presentation and receipt of immunotherapy were associated with a decreased risk of recurrence. Factors predicting poor survival included older age, malignant effusion on cytology, non-use of anti-inflammatory agents, non-lymphoma cancers and primary lung cancer. Conclusion: Among cancer patients with large PEs requiring drainage, young patients with solid tumors were more likely to experience recurrence, while elderly patients and those with lung cancer, malignant PE cytology, and non-use of anti-inflammatory agents showed worse survival.

Single Radial Access Simultaneous Left Ventricular and Ascending Aortic Pressure for the Evaluation of Aortic Stenosis: The "Double-Barrel" Technique.

The use of simultaneous left ventricular and ascending aortic pressure tracings by cardiac catheterization is the gold standard of care for accurate hemodynamic assessment of aortic stenosis severity in patients with equivocal echocardiogram. We describe the first-in-man single radial access "double-barrel" technique for the evaluation of aortic stenosis. A 7-Fr Glidesheath Slender hydrophilic-coated introducer sheath (Terumo) was placed in the right radial artery. Two 4-Fr pigtails, 1 in the left ventricle and 1 in the ascending aorta, were advanced through the single sheath. The single radial access "double-barrel" technique is a simple way to accurately evaluate patients with aortic stenosis, avoiding multiple access sites or femoral access.

2021. The year in review. Structural heart interventions.

Since the beginning of 2020, the corona virus (COVID-19) pandemic redefined in many ways the practice of cardiology, research and cardiology conferences. Virtual conferences replaced most major in-person venues. The number of "elective" structural heart interventions declined and clinical research endured major setbacks in regards to academic and industry-sponsored clinical trials. In this review, we attempt to provide a broad overview of the field for general and interventional cardiologists with a specific interest in structural heart interventions.

DIAMondback Atherectomy With OCT Visualization for Calcified PAD Lesions (DIAMOCT-PAD Study).

OBJECTIVE: In this study, we aimed to describe the immediate and long-term vascular effects of OAS in patients with peripheral arterial disease (PAD) and moderate to severely calcified lesions. BACKGROUND: Debulking the calcified atherosclerotic plaque with the orbital atherectomy system (OAS) can potentially enhance vessel compliance and increase the chance of reaching a desirable angioplasty result. METHODS: A total of 7 patients were evaluated both at baseline and at 6-month follow-up. Following a diagnostic peripheral angiogram, patients with significant SFA disease had a baseline intravascular optical coherence tomography (IV-OCT) and the lesion was treated with OAS. Repeat IV-OCT was performed after atherectomy and after drug-coated balloon, if used. Patients were also evaluated with angiography and IV-OCT imaging at their 6-month follow-up. RESULTS: The majority of tissue removed was fibrous tissue. During follow-up, luminal volume increased for 4 of the 7 patients from baseline to 6-month follow-up and decreased in 3 patients. On average there was a 6% increase of luminal volume (P<.01 compared with baseline). A recent virtual histology algorithm was used for automatic classification of IV-OCT images unaided by any reader. The algorithm used convolutional neural networks to identify regions as either calcium, fibrous, or lipid plaque, and it agreed with an expert reader 82% of the time. CONCLUSION: To the best of our knowledge, the current report is the first to describe vascular effects of OAS in medial calcified lesions immediately after and at follow-up using IV-OCT in patients with severe PAD.