Relationships, Current Issues, Safety and Efficacy of Oral Anticoagulation in Cancer Patients with Atrial Fibrillation.

A relationship between malignancy and impaired hemostasis has been proven, and balancing clotting and bleeding risks can be challenging. Half of cancer patients with atrial fibrillation (AF) do not receive any oral anticoagulation (OAC). Using PubMed on the relationship between cancer and AF and their association with hemostasis, targeting studies comparing vitamin K antagonists (VKAs) and direct OAC (DOAC) strategies in AF cancer patients, three RCTs (>3000 patients) and eight observational studies (>250,000 patients) comparing different OACs were retrieved. The VKA prescribed was always warfarin. Dabigatran was the only DOAC not analyzed in the RCTs but the most used in non-randomized studies, whereas edoxaban-treated patients were the majority in the RCTs. Overall, the DOAC patients showed similar or lower rates of efficacy (thromboembolic) and safety (bleeding) outcomes compared to the VKA patients. DOACs are subject to fewer interactions with antineoplastic agents. DOACs may be preferable to VKAs as a thromboembolic prophylaxis in cancer patients with non-valvular AF.

Systematic Review and Meta-Analysis of Oral Anticoagulant Therapy in Atrial Fibrillation Cancer Patients.

(1) Introduction: Cancer and atrial fibrillation (AF) are increasingly coexisting medical challenges. These two conditions share an increased thrombotic and bleeding risk. Although optimal regimens of the most suitable anti-thrombotic therapy are now affirmed in the general population, cancer patients are still particularly understudied on the matter; (2) Aims And Methodology: This metanalysis (11 studies (incl. 266,865 patients)) aims at evaluating the ischemic-hemorrhagic risk profile of oncologic patients with AF treated with oral anticoagulants (vitamin K antagonists vs. direct oral anticoagulants); (3) Results: In the oncological population, DOACs confer a benefit in terms of the reduction in ischemic, hemorrhagic and venous thromboembolic events. However, ischemic prevention has a non-insignificant bleeding risk, lower than Warfarin but significant and higher than the non-oncological patients; (4) Conclusions: Anticoagulation with DOACs provides a higher safety profile with respect to VKAs in terms of stroke reduction and a relative bleeding reduction risk. Further studies are needed to better assess the optimal anticoagulation strategy in cancer patients with AF.

Incidence and Predictors of Early Death in Patients Undergoing Percutaneous Left Atrial Appendage Closure.

BACKGROUND: Left atrial appendage closure (LAAC) aims to prevent ischemic events in patients with atrial fibrillation. As a preventive procedure, early death after LAAC could render the procedure futile. OBJECTIVES: The authors sought to evaluate the incidence and factors associated with early death in LAAC recipients. METHODS: This was a multicenter study including consecutive patients undergoing LAAC in a 10-year period (2009-2019). Death was considered early when occurring in the first year after LAAC. RESULTS: A total of 807 patients (mean age 76 ± 8 years, mean CHA2DS2-VASc score 4.5 ± 1.5) were included. Early death occurred in 125 patients (15.5%). In the multivariable analysis, factors associated with early death after LAAC were older age HR: 1.03; 95% CI: 1.01-1.06 per year; P = 0.01), lower body mass index (HR: 0.92; 95% CI: 0.88-0.97 per 1 kg/m2 increase; P < 0.001), diabetes (HR: 1.71; 95% CI: 1.19-2.47; P = 0.002), prior heart failure (HR: 1.74; 95% CI: 1.20-2.53; P = 0.001), and lower estimated glomerular filtration rate (HR: 1.09; 95% CI: 1.05-1.13 per 5 mL/min/1.73 m2 decrease; P < 0.001). There was a stepwise increase in risk of early death within the first year of LAAC with the combination of different risk factors (up to 48.9% in the presence of >3 risk factors). CONCLUSIONS: In this multicenter international registry, close to 1 in 6 patients died within the first year of LAAC. Older age, low body mass index, impaired estimated glomerular filtration rate, prior diabetes, and prior heart failure are independently associated with an increased risk. The risk of early death appeared to be prohibitive (∼50%) in the presence of >3 of these risk factors.

Management and Outcome of Failed Percutaneous Edge-to-Edge Mitral Valve Plasty: Insight From an International Registry.

OBJECTIVES: This study evaluated the incidence, management, and outcome of patients who experienced MitraClip (Abbott Vascular) failure secondary to loss of leaflet insertion (LLI), single leaflet detachment (SLD), or embolization. BACKGROUND: Transcatheter edge-to-edge repair with MitraClip is an established therapy for the treatment of mitral regurgitation (MR), but no data exist regarding the prevalence and outcome according to the mode of clip failure. METHODS: Between January 2009 and December 2020, we retrospectively screened 4,294 procedures of MitraClip performed in 19 centers. LLI was defined as damage to the leaflet where the MitraClip was attached, SLD as demonstration of complete separation between the device and a single leaflet tissue, and clip embolization as loss of contact between MitraClip and both leaflets. RESULTS: A total of 147 cases of MitraClip failure were detected (overall incidence = 3.5%), and these were secondary to LLI or SLD in 47 (31.9%) and 99 (67.3%) cases, respectively, whereas in 1 (0.8%) case clip embolization was observed. MitraClip failure occurred in 67 (45.5%) patients with functional MR, in 64 (43.5%) patients with degenerative MR, and 16 (10.8%) with mixed etiology. Although the majority of MitraClip failures were detected before discharge (47 intraprocedural and 42 in the hospital), up to 39.5% of cases were diagnosed at follow-up. In total, 80 (54.4%) subjects underwent a redo procedure, either percutaneously with MitraClip (n = 51, 34.7%) or surgically (n = 36, 24.5%) including 4 cases of surgical conversion of the index procedure and 7 cases of bailout surgery after unsuccessful redo MitraClip. After a median follow-up of 163 days (IQR: 22-720 days), 50 (43.9%) subjects presented moderate to severe MR, and 43 (29.3%) patients died. An up-front redo MitraClip strategy was associated with a trend toward a reduced rate of death at follow-up vs surgical or conservative management (P = 0.067), whereas postprocedural acute kidney injury, age, and moderate to severe tricuspid regurgitation were independent predictors of death. CONCLUSIONS: MitraClip failure secondary to LLI and SLD is not a rare phenomenon and may occur during and also beyond hospitalization. Redo MitraClip strategy demonstrates a trend toward a reduced risk of death compared with bailout surgery and conservative management. A third of those patients remained with more than moderate MR and had substantial mortality at the intermediate-term follow-up.

Diagnosis and Management of Failed Surgical Tricuspid Valve Annuloplasty.

PURPOSE OF THE REVIEW: Annular-based strategies for treating tricuspid valve (TV) regurgitation do not always have satisfactory long-term outcomes. Management of failed TV annuloplasty can be challenging and requires a dedicated heart team approach. This review explores the treatment options available for failed TV annuloplasty. RECENT FINDINGS: Recent developments and novel percutaneous treatment options have emerged as promising alternatives for patients with failed TV annuloplasty. Leaflet-based interventions, valve-in-valve procedures, transcatheter tricuspid valves and new-generation trans-caval valves are all feasible options, which can assure good results whilst minimizing risks for the patient. Failure of tricuspid annuloplasty is not uncommon amongst patients treated with either a tricuspid ring or suture-based device. The complex anatomy, physiology and clinical risk profile should be carefully evaluated on an individual patient-by-patient basis in order to select the most appropriate clinical and percutaneous treatment strategy. Different transcatheter tricuspid valve repair or replacement techniques may provide an attractive alternative treatment option for managing this challenging patient cohort.

Incidence, predictors, and clinical impact of bleeding recurrence in patients with prior gastrointestinal bleeding undergoing LAAC.

BACKGROUND: Gastrointestinal bleeding (GIB) is associated with a high recurrence rate and a prior GIB episode is common in real-world left atrial appendage closure (LAAC) recipients. The present study sought to evaluate the clinical characteristics and outcomes of patients with prior GIB undergoing LAAC, and to determine the factors associated with and clinical impact of GIB recurrence. METHODS: Multicenter study including 277 consecutive patients who underwent percutaneous LAAC and had prior GIB. All-cause death, all bleeding, GIB recurrence, and clinical ischemic stroke were recorded. RESULTS: After a median follow-up of 17 (interquartile range: 6-37) months post-LAAC, the rates of death, bleeding, GIB recurrence, and ischemic stroke were 14.0 per 100 person-year (PY), 29.3 per 100 PY, 17.7 per 100 PY, and 1.1 per 100 PY, respectively. GIB recurrence occurred within 3 months post-LAAC in 55.8% of patients. A previous lower GIB (vs. upper or unclassified) (HR: 1.76; 95% CI: 1.09-2.82; p = .020) and eGFR < 45 mL/min (HR: 1.70; 95% CI:1.04-2.67; p = .033) determined an increased risk of GIB recurrence. By multivariable analysis, eGFR < 45 mL/min (HR: 2.72; 95% CI: 1.70-4.34; p < .001), GIB recurrence following LAAC (HR: 2.15; 95% CI: 1.33-3.46; p = .002), diabetes mellitus (HR: 1.77; 95% CI: 1.10-2.84; p = .018), and age (HR: 1.06; 95% CI: 1.03-1.10; p < .001) were associated with an increased mortality. CONCLUSIONS: Patients with prior GIB undergoing LAAC exhibited a relatively low rate of GIB recurrence, and prior lower GIB and moderate-to-severe chronic kidney disease determined an increased risk. GIB recurrence was associated with an increased mortality.

Computed tomography analysis of coronary ostia location following valve-in-valve transcatheter aortic valve replacement with the ACURATE neo valve: Implications for coronary access.

BACKGROUND: Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) is an emerging alternative to re-do surgery. However, the challenge of coronary access (CA) following ViV-TAVR is a potential limitation as TAVR expands to younger lower-risk populations. OBJECTIVES: Using post-implantation computed tomography (CT) scans to evaluate the geometrical relationship between coronary ostia and valve frame in patients undergoing ViV-TAVR with the ACURATE neo valve. METHODS: Post-implant CT scans of 18 out of 20 consecutive patients treated with the ACURATE neo valve were analyzed. Coronary ostia location in relation to the highest plane (HP) (highest point of the ACURATE neo or surgical valve) was determined. Ostia located below the highest plan were further subclassified according to the gap available between the transcatheter heart valve frame and ostium (transcatheter-to-coronary [TTC] distance). The impact implantation depth has on these geometrical relationships was evaluated. RESULTS: A total of 21 out of 36 coronary ostia (58%) were located below the level of the HP with the left coronary artery (36%) more likely to be affected than the right (22%). Further sub-classification of these ostia revealed a large (>6 mm), moderate (4-6 mm), and small (<4 mm) TTC distance in 57% (12/21), 38% (8/21), and in 6% (1/18) of cases, respectively. At an implantation depth <4 mm compared to >4 mm, all ostia were located below the HP with no difference in post-procedural mean gradients (14.5 mmHg ± 4.7 vs. 12.6 mmHg ± 5.8; p = .5, 95%CI 3.8-7.5). CONCLUSIONS: CA following ACURATE neo implantation for ViV-TAVR could potentially be challenging in a significant proportion of patients and specific consideration should be given to the implantation depth.

Transcatheter aortic valve replacement: potential use in lower-risk aortic stenosis.

INTRODUCTION: The widespread use of transcatheter aortic valve implantation (TAVI) is expanding to low-risk patients. Nevertheless, a low clinical risk does not always correspond to a low procedural risk for the percutaneous approach. AREAS COVERED: The initial trials on TAVI in low-risk populations had encouraging results, showing non-inferiority in comparison to surgical aortic valve replacement (SAVR). However, the low-risk definition is based on risk score calculators developed for the surgical setting and not including other specific features that are more relevant to TAVI and can affect procedural outcomes. For example, the presence of bicuspid aortic valves, high calcific burden, low coronary height or conduction disturbances is all potentially associated with suboptimal results or even procedural complications. In addition, the lack of longer follow-up prevents us to draw conclusions about long-term outcomes, including data about valve durability and coronary re-access. EXPERT OPINION: Although current evidence suggest similar results for TAVI and SAVR in low-risk populations, there are some technical and procedural limitations that still need to be addressed in order to close the gap between TAVI and surgery. Optimal, lasting results with a low rate of procedural complications are highly expected in low-risk, otherwise healthy subjects, with potential for longevity.

The Utility of Rapid Atrial Pacing Immediately Post-TAVR to Predict the Need for Pacemaker Implantation.

OBJECTIVES: The aim of this study was to determine the utility of rapid atrial pacing immediately after transcatheter aortic valve replacement (TAVR) to predict the need for permanent pacemaker implantation (PPI). BACKGROUND: Risk stratification for patients without high-grade atrioventricular block (AVB) after TAVR is imprecise and based on anatomic considerations, electrocardiographic characteristics, and clinical suspicion. A more reliable assessment is necessary to minimize inpatient rhythm monitoring and/or reduce unnecessary PPI. METHODS: Consecutive patients undergoing TAVR at 2 centers were included. After valve implantation in patients without pacemakers who did not have complete heart block or atrial fibrillation, the temporary pacemaker was withdrawn from the right ventricle and placed in the right atrium. Rapid atrial pacing was performed from 70 to 120 beats/min, and patients were assessed for the development of Wenckebach AVB. Patients were then followed for clinical outcomes, including PPI. RESULTS: A total of 284 patients were included. Of these, 130 (45.8%) developed Wenckebach AVB. There was a higher rate of PPI within 30 days of TAVR among the patients who developed Wenckebach AVB (13.1% vs. 1.3%; p < 0.001), with a negative predictive value for PPI in the group without Wenckebach AVB of 98.7%. A greater percentage of patients receiving self-expanding valves required PPI than those receiving a balloon-expandable valves (15.9% vs. 3.7%; p = 0.001), though these rates were still relatively low among patients who did not develop Wenckebach AVB (2.9% and 0.8%). CONCLUSIONS: Atrial pacing post-TAVR is easily performed and can help identify patients who may benefit from extended rhythm monitoring. Patients who did not develop pacing-induced Wenckebach AVB demonstrated an extremely low likelihood of PPI.

Rotational atherectomy-based percutaneous coronary intervention and the risk of contrast-induced nephropathy.

BACKGROUND: Rotational atherectomy (RA)-related complications (e.g., no-reflow and perforation) may be associated with increased risk of contrast-induced nephropathy (CIN), causing hypotension, acute heart failure, and periprocedural myocardial infarction. Our aim was to evaluate the incidence of CIN in patients undergoing RA-based vs. non-RA-based percutaneous coronary intervention (PCI). METHODS: This single-center retrospective registry included all patients who underwent PCI between 2012 and 2016 for whom post-procedural creatinine was determined. Study endpoint was CIN, defined as an increase of serum creatinine ≥0.3 mg/dL or ≥50% from baseline within 72 h post-PCI. Propensity score matching (PSM) was performed to account for selection bias between RA and non-RA patients. RESULTS: Study population included 2580 patients: 70 (3%) had RA PCI and 2510 (97%) had non-RA PCI. Following PSM, there were 70 patients in RA and 280 patients in non-RA group with good overall adjustment between groups, although RA patients received larger contrast volume (263±126 vs. 224±118 mL, P=0.01) and showed higher Mehran risk score at baseline (11.1±6.6 vs. 8.9±4.8, P=0.01). The incidence of CIN was similar between RA and non-RA patients (15.7% vs. 13.2%, P=0.59). New need for dialysis was required in 0% vs. 0.7% patients, respectively (P=0.48). On multivariate analysis, RA PCI was not independently associated with development of CIN. CONCLUSIONS: Despite being performed in patients with a higher burden of comorbidities and with larger volumes of contrast, RA PCI is not associated with higher risk of CIN, compared with PCI in non-RA patients.

Dual antiplatelet therapy in coronary artery disease: from the past to the future prospective.

Antiplatelet therapy, the cornerstone of post coronary stenting antithrombotic therapy, reduces the rate of hard clinical endpoints in patients treated both conservatively and invasively following an acute coronary syndrome, as well as in those patients with chronic stable coronary disease who receive a coronary stent. The development of newer antiplatelet and direct anticoagulant agents provides new options in the antithrombotic management of patients with coronary artery disease, enabling different therapeutic combinations to be tailored to an individual patient's bleeding and ischemic risk profile. In this review, we will summarize the history of dual antiplatelet therapy, discuss the latest evidence and future perspectives in treating patients with coronary artery disease.

New Percutaneous Options for Tricuspid Intervention: How to Identify the Good Clinical Candidate.

The tricuspid valve has been neglected for a long time and severe tricuspid regurgitation (TR) was largely undertreated in the past due to a high operative risk. In the last years we observed the development of different less invasive percutaneous options to treat TR. Currently, percutaneous treatments are reserved for high-risk patients presenting with advanced stage disease by which time they are likely to derive a partial benefit at best. There is a limited evidence base, including no randomized trials, to guide the management strategy for severe TR. In the interim we feel that choosing the best device for the most appropriate clinical candidate and with an adequate timing (most probably an "earlier" timing) will be the key combination to improve early and late outcomes of percutaneous treatments.

Perceval sutureless valve migration treated by valve-in-valve with a CoreValve Evolut Pro.

In the last years, the use of sutureless devices in frail patients with severe aortic stenosis has increased thanks to their "easier and faster" technique of implantation in comparison to conventional surgery. Results from metanalysis show comparable outcomes in comparison to transcatheter aortic valve replacement (TAVR) in terms of mortality, stroke incidence, and rate of pace-maker implantation. The incidence of para-valvular leak (PVL) is even lower for sutureless devices than for TAVR. The few cases described are generally due to incomplete decalcification or incorrect valve sizing and consequent stent distortion. To our knowledge this is the first case describing PVL with massive aortic regurgitation due to early partial embolization of a Perceval valve and its successfully treatment with valve-in-valve by using a self-expanding TAVR device.

Sex and Transcatheter Aortic Valve Implantation: Impact of Female Sex on Clinical Outcomes.

Transcatheter aortic valve implantation (TAVI) has emerged as an alternative treatment for severe symptomatic aortic stenosis in patients who are not suitable for surgery or are at high surgical risk. Approximately 50% of patients undergoing TAVI are female and this is reflected by a higher inclusion rate of women in TAVI trials. However, women undergoing TAVI have different baseline clinical characteristics in comparison to men, with fewer comorbidities and a more preserved left ventricular ejection fraction. This translates into favourable outcomes after TAVI, despite a higher rate of peri-procedural complications. This article discusses gender differences in terms of presentation, procedural characteristics and post-procedural results in patients with aortic stenosis undergoing TAVI, with particular focus on possible sex-specific factors affecting outcome.

Temporal trends in procedural death and need for urgent open surgery during transcatheter aortic valve replacement: A single, high-volume center 10-year experience.

BACKGROUND: Despite advancements in the safety of transcatheter aortic valve replacement (TAVR) resulting in progressively wider indications, adverse periprocedural outcomes still raise concern. Real-world outcome data are thus of primary importance to evaluate the procedural risk-benefit trade-off in the continuously changing populations undergoing TAVR. METHODS: We retrospectively assessed 1348 consecutive patients undergoing TAVR between 2007 and 2017. The primary endpoint was a composite of procedural mortality and need for conversion to emergent surgery, as defined by the Valve Academic Research Consortium-2 criteria. Temporal trends in baseline characteristics and outcomes were evaluated. The independent outcomes predictors were assessed through multivariate regression analysis. RESULTS: A total of 56 (4.1%) patients experienced the primary endpoint. 47 (3.5%) patients died during hospital stay, 19 (1.4%) within 72 h from the procedure. 17 patients (1.2%) needed an emergent conversion to open surgery, of whom 7 (41.2%) did not survive. Significant temporal trends of increasing mean age (from 79.4 ±â€¯7.4 to 81 ±â€¯7.5, p = 0.007) and decreasing surgical risk (mean STS: from 9 ±â€¯9.5 to 7.1 ±â€¯9.8, p = 0.010) were observed. When dichotomized at the median procedural date (year 2014), a significant reduction in the occurrence of the primary endpoint in more recent years was observed (3.0% vs 5.2%, p = 0.041). This was the single primary endpoint independent predictor at multivariate analysis. CONCLUSION: The high-volume 10-year experience in TAVR procedures at our center shows encouraging trends in procedural mortality reduction, which anyhow still occurs at a non-negligible rate, calling for further research to detect and to blunt the determinant of early procedural events.

Impact of horizontal aorta on procedural and clinical outcomes in second-generation transcatheter aortic valve implantation.

AIMS: The aim of this study was to evaluate the impact of a horizontal aorta (HA) on device success and short-term clinical outcomes of transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We retrospectively assessed 547 consecutive patients treated with transfemoral second-generation non-balloon-expandable (NBE) (n=447) and balloon-expandable (BE) (n=100) TAVI for symptomatic severe aortic stenosis. Aortic angulation (AA) was evaluated with preprocedural computed tomography. Patients were dichotomised according to a previously established AA cut-point: HA group (AA ≥48°, n=230) and normal aorta (NA) group (AA <48°, n=317). Endpoints were considered according to the Valve Academic Research Consortium-2 definitions. Fluoroscopy time (32.8±16.4 vs 30.3±13.9 minutes, p=0.060) and radiation dose (kerma area product 120.8±99.7 vs 103.7±81.1 Gy·cm2, p=0.033) were higher in the HA group as compared to the NA group. No difference in device success was observed between patients with and without an HA (88.3% vs 88.0%, p=0.929). No differences in device success and 30-day outcomes were observed when comparing HA and NA patients, according to BE and NBE prostheses. CONCLUSIONS: The presence of an HA has no impact on device success and short-term clinical outcomes of TAVI with either second-generation NBE or BE devices.

Peri-Procedural Acute Coronary Syndrome During Transcatheter Aortic Valve Replacement.

A 76-year-old male with severe chronic kidney disease, porcelain aorta and an oral squamous cell carcinoma (scheduled for chemotherapy and surgical excision) underwent transfemoral aortic valve replacement (TAVR) with a CoreValve Evolut R 34 due to severe aortic stenosis. The percutaneous treatment of a severely calcified stable lesion on ostial left circumflex (LCx) artery was not considered a priority due to the patient's comorbidities and the concerns about dual antiplatelet therapy. However, shortly afterwards valve deployment the patient developed an acute myocardial ischemia on the lateral wall due to LCx artery lesion becoming unstable; it was successfully treated with urgent coronary angioplasty and drug eluting stent implantation. A combination of multiple precipitating factors could be involved in the development of acute coronary syndrome during TAVR procedures.

Risk of contrast-induced nephropathy in patients undergoing complex percutaneous coronary intervention.

BACKGROUND: Complex percutaneous coronary intervention (PCI) is associated with increased procedural challenges and high contrast load. We aimed to evaluate the association between complex PCI and contrast-induced nephropathy (CIN). METHODS: This single-center retrospective study included all-comers undergoing PCI between January 2012 and December 2016. Complex PCI was defined as a procedure with ≥1 of the following characteristics: 3 vessels treated, ≥3 stents implanted, two-stent bifurcation intervention, total stent length >60 mm, PCI on a chronic total occlusion, saphenous vein graft, or left main, protected PCI, use of rotational/laser atherectomy. CIN was defined as an increase in post-PCI creatinine of ≥0.3 mg/dl or ≥50% from baseline. RESULTS: We included 2660 patients (n = 1128 complex PCI, n = 1532 non-complex PCI). Complex PCI patients tended to be older, and had higher cardiovascular comorbidity and Mehran CIN risk score. They also had a higher prevalence of type B2/C lesions and need for mechanical circulatory support, and received a higher mean contrast volume (284 ±â€¯137 vs. 189 ±â€¯90 ml, p < 0.001). CIN incidence was similar in complex vs. non-complex PCI patients (12.1% vs. 11.5%, p = 0.63), as was the need for in-hospital dialysis (0.5% vs. 0.2%, p = 0.25). Upon multivariable adjustment, age, female sex, diabetes, ejection fraction, periprocedural hypotension, presentation with acute coronary syndrome, and contrast volume were independently associated with CIN, while complex PCI was not. CONCLUSIONS: Complex PCI is not associated with an increased risk of CIN in all-comers. Further studies should confirm our findings and investigate novel effective strategies to decrease the risk of this serious complication.