Transcatheter edge-to-edge repair of the tricuspid valve: The US experience.

OBJECTIVES: To examine the trends in utilization and outcomes of tricuspid valve (TV) transcatheter edge-to-edge repair (TEER). BACKGROUND: Surgery for isolated tricuspid regurgitation is associated with high morbidity and mortality and is rarely performed. TV TEER is an attractive alternative. METHODS: The Nationwide Readmissions Database was queried using the International Classification of Diseases, 10th Revision, procedure code for TV TEER for years 2016-2019. The main outcomes were trends in utilization and in-hospital all-cause mortality. RESULTS: We identified 918 hospitalizations for TV TEER. There was an uptrend in its utilization from 13 cases in the first quarter of 2016 to 122 cases in the last quarter of 2019 (p trend < 0.001). Concomitant mitral valve (MV) TEER was performed in 42.1% of admissions. The overall in-hospital mortality was 2.1%. Surgical TV replacement was needed in 1.1% of admissions; none of them died during the index hospitalization. Unplanned rehospitalizations were common at 30 days (15.7%); 38.2% of those were due to heart failure. There was no difference in in-hospital mortality between isolated TV TEER and combined MV and TV TEER (1.7% vs. 2.6%, p = 0.359). However, admissions receiving combined procedure had lower length of stay and urgent readmission rate. CONCLUSION: The current study showed that there was an increase in the utilization of TV TEER over 2016-2019 in the United States. TV TEER was associated with low rates of in-hospital mortality; however, the rate of urgent readmission remains high, mainly due to heart failure.

Patent foramen ovale transcatheter closure vs. medical therapy on recurrent vascular events: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: In patients with cryptogenic stroke, transcatheter (TC) closure of a patent foramen ovale (PFO) has not been shown to better prevent recurrent vascular events than medical therapy. However, randomized controlled trials (RCT) to date have included few vascular events, and lack of power has been raised as an important concern. OBJECTIVE: To conduct a systematic review and meta-analysis of existing RCT published studies assessing the recurrence of vascular events after TC PFO closure when compared to medical therapy. METHODS: Using the search terms "patent foramen ovale", "PFO", "stroke", "percutaneous closure" and "transcatheter closure", Medline, Pubmed, Embase, and Cochrane databases were reviewed from inception through April 2013, with no language restrictions. Only studies in adult humans were considered. Additional references were obtained from the bibliographies of studies reviewed. The following criteria were used for study selection: 1) randomized controlled trial, 2) subjects were adult patients with cryptogenic stroke who were randomized to TC PFO closure or medical treatment (antiplatelet therapy and/or anticoagulation), and 3) reported outcomes included cardiac death, all death, stroke, transient ischemic attack, and peripheral embolism. Methodological and descriptive data, adverse events (including raw data and risk estimates), as well as procedural success and complications were abstracted in duplicate from each study independently, and agreement was tested. We followed rigorously the recommended guidelines for reporting and conducting and assessing quality of meta-analysis of RCT. The primary endpoints pre-specified in advance were recurrent vascular events, and composite endpoint of death, and recurrent vascular events. RESULTS: Three studies were identified as meeting selection criteria. These included a total of 2,303 patients, with 1,150 patients randomized to TC PFO closure and 1,153 patients randomized to medical therapy. Mean follow-up was 3.5 years. Baseline characteristics (age, sex, and cardiovascular risk factors) were similar across studies. Intention-to-treat analyses showed a statistically significant risk reduction in stroke and/or transient ischemic attack in the TC PFO closure group when compared to medical treatment, pooled HR = 0.59, 95%CI (0.36-0.97), P = 0.04. The combined outcome of death, and vascular events, showed a borderline statistically significant benefit for TC PFO closure when compared to medical treatment, pooled HR = 0.67, 95%CI (0.44-1.00), P = 0.05 Subjects with a substantial PFO shunt seem to benefit the most with TC PFO closure, pooled HR = 0.35, 95%CI (0.12-1.03), P = 0.06, however, it did not reach statistical significance. CONCLUSION: These results suggest that in patients with cryptogenic stroke, TC PFO closure may be beneficial in reducing the risk of recurrent vascular events when compared to medical treatment. The benefit of TC PFO closure may be greater in patients with a substantial shunt.

Contemporary National Trends and Outcomes of Pulmonary Embolism in the United States.

Contemporary data on the national trends in pulmonary embolism (PE) admissions and outcomes are scarce. We aimed to analyze trends in mortality and different treatment methods in acute PE. We queried the Nationwide Readmissions Database (2016 to 2019) to identify hospitalizations with acute PE using the International Classification of Diseases, Tenth Revision, Clinical Modification codes. We described the national trends in admissions, in-hospital mortality, readmissions, and different treatment methods in acute PE. We identified 1,427,491 hospitalizations with acute PE, 2.4% of them (n = 34,446) were admissions with high-risk PE. The rate of in-hospital mortality in all PE hospitalizations was 6.5%, and it remained unchanged throughout the study period. However, the rate of in-hospital mortality in high-risk PE decreased from 48.1% in the first quarter of 2016 to 38.9% in the last quarter of 2019 (p-trend <0.001). The rate of urgent 30-day readmission was 15.2% in all PE admissions and 19.1% in high-risk PE admissions. In all PE admissions, catheter-directed interventions (CDI) were used more often (2.5%) than systemic thrombolysis (ST) (2.1%). However, in admissions with high-risk PE, ST remained the most frequently used method (ST vs CDI: 11.3% vs 6.6%). In conclusion, this study showed that the rate of in-hospital mortality in high-risk PE decreased from 2016 to 2019. ST was the most frequently used method for achieving pulmonary reperfusion in high-risk PE, whereas CDI was the most frequently used method in the entire PE cohort. In-hospital death and urgent readmissions rates remain significantly high in patients with high-risk PE.

Failure of Complete Endothelialization of a Watchman Device 3 Years Post-Implantation.

We report an unusual case of incomplete endothelialization of the Watchman device >3 years after its implantation. Animal data suggest that device endothelialization occurs ∼45 days post-implantation; however, data on humans are lacking. Guidelines on anticoagulation are based on expectation from animal studies. (Level of Difficulty: Advanced.).

Suicide left ventricle following transcatheter aortic valve implantation.

In some patients with aortic stenosis, dynamic intraventricular gradients like those seen in hypertrophic obstructive cardiomyopathy may develop secondary to left ventricular hypertrophy from chronic pressure overload. With the advent of transcatheter aortic valve implantation, many patients with aortic stenosis and advanced age who formerly would be considered "too high risk" for aortic valve replacement are getting treatment for their aortic stenosis. This case highlights the hemodynamic aberrations that can occur with TAVI leading to a cautionary note regarding implementation of this rapidly emerging technique in patients with left ventricles that may be at risk for suicide left ventricle.

Prevalence and Clinical Correlates of Extended Mechanical Support in Patients Undergoing High-Risk Percutaneous Coronary Intervention in Current Clinical Practice: Insights from the cVAD Registry.

BACKGROUND: High-risk percutaneous coronary interventions (HR-PCI) are prone to hemodynamic instability, resulting in poor outcomes. Acute mechanical circulatory support (AMCS) devices are used during HR-PCI to improve outcomes. However, the clinical criteria for extended AMCS have not been well characterized. The aim of this study was to describe the prevalence and clinical correlates of extended AMCS in patients undergoing elective or urgent HR-PCI. METHODS: We retrospectively analyzed 507 patients enrolled in the catheter-based ventricular assist device (cVAD) registry who underwent elective or urgent HR-PCI with prophylactic use of Impella. The study population was divided into two groups: Impella support removed immediately after PCI (Group A, n = 464) and extended support after PCI (Group B, n = 43). Multivariable regression analysis was used to identify independent predictors of extended AMCS. RESULTS: Baseline characteristics were similar between the groups. Non-ST-elevation myocardial infarction in 26.3% in Group A vs 41.8% in Group B (p = 0.03). PCI of left main was common in Group A (p = 0.02), whereas the right coronary artery was common in Group B (p < 0.001). The mean duration of Impella support 1.1 ±â€¯0.6 h in Group A vs 11.4 ±â€¯16.8 h in Group B (p < 0.001). Death and vascular complications were higher with extended Impella support. Revascularization of chronic total occlusion (CTO) was an independent predictor of extended Impella support (OR 3.2, 95% CI 1.20-8.53). CONCLUSIONS: About 9% of patients enrolled in the cVAD registry undergoing elective or urgent HR-PCI received extended Impella support. In-hospital mortality was about 12% in patients requiring extended Impella support. CTO was associated with a higher likelihood of extended AMCS. The hemodynamic benefits of extended AMCS support must be weighed in terms of risk of complications.

Retrograde versus antegrade percutaneous aortic balloon valvuloplasty: immediate, short- and long-term outcome at 2 years.

BACKGROUND: The short- and long-term vascular risks and hemodynamic benefits of antegrade versus retrograde percutaneous aortic balloon valvuloplasty (PAV) have not been clearly established. With the advent of percutaneous aortic valve replacement strategies, more valvuloplasties are being performed. The antegrade approach may reduce vascular complications, particularly in patients with peripheral vascular disease (PVD). Comparing the clinical efficacy and complications of each technique is warranted. METHODS: A cohort of 157 consecutive patients undergoing PAV between 2000 and 2006 were included in the study. Of these, 46 (29%) patients underwent antegrade PAV and 111 (71%) retrograde PAV. Choice of vascular approach (antegrade or retrograde) were determined by operator preference. The rate of death, nonfatal vascular complications, and 2-year survival was explored. RESULTS: The mean age of the study population was 79 years. Patients undergoing antegrade PAV were more likely hypertensive (56% vs. 39%, P = 0.001) with PVD (41% vs. 18%, P = 0.004). Nevertheless, logistic Euroscores were no different between the groups (antegrade 18% vs. retrograde 14%; P = 0.30). Baseline and postprocedural valve areas were also similar. However, patients undergoing antegrade PAV had significantly fewer vascular complications (2% vs. 19%; P = 0.005). Two-year follow-up revealed no significant difference in death (antegrade 81% vs. retrograde 69%; P = 0.16), stroke, congestive heart failure, and surgical aortic valve replacement. CONCLUSIONS: The hemodynamic benefit of PAV occurs regardless of the selected vascular approach. The antegrade technique results in significantly fewer vascular complications and similar long-term outcomes. Antegrade PAV is feasible and safe, particularly in patients with PVD.

Coronary in-stent restenosis following beta brachytherapy: a histopathological examination.

Two cases of in-stent restenosis of a coronary artery bypass vein graft following beta (beta) brachytheraphy are presented. Previously unreported histopathology of directed atherectomy specimens of such restenotic lesions and a discussion of their proposed significance form the basis of this report.

The changing pattern of coronary perforation during percutaneous coronary intervention in the new device era.

We report the incidence, management and clinical outcome of coronary perforations in 39 of 12,658 patients (0.3%) undergoing percutaneous coronary intervention (PCI). Coronary perforation occurred more frequently with debulking techniques than with non-debulking (percutaneous transluminal coronary angioplasty and stent) techniques (1% versus 0.2%; p<0.001). There were 8 type I (20.5%), 15 type II (38.5%) and 16 type III (41%) perforations. Importantly, fifty-one percent of the coronary perforations were guide-wire related. Major adverse clinical outcomes occurred more frequently in patients who experienced type III perforations. Conventional strategies to treat perforations (i.e., prolonged balloon inflation and reverse of the anticoagulated state) were used. There was one death (2.6%), two emergency surgeries (5.2%) and no Q-wave myocardial infarctions. Pericardial effusion occurred in 18 of 39 patients (46.2%), with cardiac tamponade occurring in 7 patients. In the current device era, the incidence of coronary perforation remains low; it occurs more frequently with debulking devices and is often a consequence of guidewire injury. Its outcome is not affected with the use of IIb/IIIa antagonists. Treatment of coronary perforation requires early detection, angiographic classification, immediate occlusion of coronary vessel extravasation and relief of hemodynamic compromise, reversal of heparin anticoagulation, platelet transfusion in those patients treated with abciximab and cover stents.