Percutaneous Coronary Intervention with Procedural Unfractionated Heparin without Activated Clotting Time Guidance: A Unique Opportunity to Assess Thrombotic and Bleeding Events.

Background: Rates of major bleeding and intraprocedural thrombotic events (IPTE) in the setting of percutaneous coronary intervention (PCI) using weight-adjusted unfractionated heparin (UFH) without activated clotting time (ACT) monitoring are not known. Methods: We reviewed 2,748 consecutive patients who underwent coronary angiography at our tertiary care university hospital between January 2017 and December 2020. All patients who underwent PCI with weight-adjusted UFH without ACT guidance were considered for further analysis. Major bleeding complications occurring within 48 hours of PCI were collected from patients' medical records. IPTE were collected independently by two interventional cardiologists after review of coronary angiograms. Results: There were 718 patients included in the analysis (65.4 ± 12.2 years old; 81.3% male). In total, 45 patients (7.8%) experienced a major bleed or IPTE. The most common IPTE were slow/no reflow (1.5%) and coronary artery dissection with decreased flow (1.1%). Other IPTE occurred in <1% of cases. Major bleeding occurred in 11 patients (1.5%), of whom 8 required blood transfusion and 3 required vascular intervention. Bleeding complications were more common with femoral compared with radial access (6.6% vs. 0.2%, P < 0.001). Conclusion: Weight-adjusted UFH use during PCI without ACT monitoring was related to low rates of major bleeding or IPTE.

Coronary artery disease, revascularization, and clinical outcomes in transcatheter aortic valve replacement: Real-world results from the East Denmark Heart Registry.

Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for patients with symptomatic, severe aortic stenosis. The optimal treatment strategy for concomitant coronary artery disease (CAD) has not been tested prospectively in a randomized clinical trial. This study aimed to describe the degree of CAD, revascularization strategies, and long-term clinical outcomes in a large-scale all-comers TAVR-population. Nine hundred and forty-four consecutive patients underwent TAVR. Obstructive CAD was reported in 224 patients (23.7%)-of these, 150 (66.9%) presented with one-vessel disease (1-VD), 51 (22.8%) with 2-VD, and 23 (10.3%) with 3-VD. Two-thirds underwent coronary revascularization before TAVR; half of those patients with 1-VD and only one-third of those with multivessel disease were completely revascularized. In general, borderline stenoses (50%-70%) were more frequently revascularized in proximal coronary segments than in more distal segments. Long-term survival rates by Kaplan-Meier analysis of the total TAVR population at 5 and 9 years were 64.7% and 54.1%, respectively. A diagnostic coronary angiography was performed in 16.5% of patients within 5 years after TAVR; only 4.8% underwent consequent percutaneous coronary intervention (PCI). There was no difference in survival and need for revascularization post-TAVR between those patients with or without obstructive CAD ± revascularization. Neither was there a survival difference between those with or without previous CABG and/or chronic total occlusion(s). In conclusion, CAD is prevalent in TAVR patients and pre-TAVR coronary revascularization is typically focused on treating proximal and high-grade stenosis. A selective pre-TAVR PCI strategy results in favorable clinical outcomes with very low rates of post-TAVR coronary revascularization.

Short-versus long-term Dual Antiplatelet therapy after drug-eluting stent implantation in women versus men: A sex-specific patient-level pooled-analysis of six randomized trials.

BACKGROUND: Whether the efficacy and safety of dual antiplatelet therapy (DAPT) are uniform between sexes is unclear. We sought to compare clinical outcomes between short- (≤6 months) versus long-term (≥1 year) DAPT after drug-eluting stent (DES) placement in women and men. METHODS AND RESULTS: We pooled individual patient data from 6 randomized trials of DAPT (EXCELLENT, OPTIMIZE, PRODIGY, RESET, SECURITY, ITALIC PLUS). The primary outcome was 1-year risk of major adverse cardiac events (MACE). The main secondary outcome was 1-year risk of any bleeding. Out of the 11,473 randomized patients included in the pooled dataset, 3,454 (30%) were females. At 1-year follow-up, women had higher risk of MACE (3.6% vs. 2.8%; P = 0.01) but similar risk of bleeding (1.9% vs. 1.6%; P = 0.16) as compared with men. Compared with long-term DAPT, short-term DAPT was associated with similar rates of MACE in both women (HR 0.88; 95% CI 0.62-1.25) and men (HR 1.25; 95% CI 0.95-1.6; P interaction = 0.08)]. At 1-year follow-up, short-term DAPT was associated with lower rates of bleeding as compared with long-term DAPT in both women (HR 0.84; 95% CI 0.51-1.37) and men (HR 0.58; 95% CI 0.40-0.84; P-interaction = 0.25). The presence of MVD was associated with higher MACE rates in the short-term DAPT group in women (HR: 1.16; CI 0.60-2.23) and men (HR: 2.29; CI 1.22-4.29; P interaction = 0.25). CONCLUSIONS: Short-term DAPT is associated with similar rates of MACE but lower risk of bleeding when as compared with prolonged DAPT. There was no significant difference between sexes in the population studied. © 2016 Wiley Periodicals, Inc.

Transfemoral Transcatheter Aortic Valve Implantation: How Minimalistic Can We Become?

Transcatheter aortic valve implantation (TAVI) has become a well-established intervention with reproducible and excellent early and mid-term outcomes. A minimalist approach to TAVI is already the standard of care in many experienced centers. In this report, we share our experience and opinions on how we can further simplify the TAVI procedure in hope to establish the best possible outcomes.

Comparison of Transradial vs Transfemoral Access for Aortoiliac and Femoropopliteal Interventions: A Single-Center Experience.

PURPOSE: To compare the procedure and safety outcomes of the transradial approach (TRA) with the femoral approach (FA) for treating aortoiliac and femoropopliteal stenoses and occlusions. METHODS: A single-center retrospective study was conducted involving 188 patients (mean age 66.4±10.8 years; 116 men) with lower limb claudication or critical limb ischemia who underwent aortoiliac (131, 62.4%) or femoropopliteal (79, 37.6%) interventions on 210 lesions over a 3-year period. Operator discretion determined TRA suitability; exclusions included Raynaud's disease, upper limb occlusive disease, previous TRA difficulties, or planned hemodialysis. Lesion characteristics, clinical endpoints, and access site complications were compared. RESULTS: FA was used primarily in 123 patients and the TRA (12 left and 53 right radial arteries) in 65 procedures. Eleven (16.9%) TRAs failed vs 9 (7.3%) FAs (p=0.42). Crossover to FA was due to occlusive lesions requiring alternative equipment in 9 cases and to tortuosity of the aortic arch vessels in 2 patients. The 134 FA interventions (balloon angioplasty, stents) were retrograde (112, 83.6%) or antegrade (22, 16.4%). There were significantly more TASC C/D lesions in the FA group (p=0.02). Sheath sizes (5-F to 8-F) did not differ between groups, and no significant differences were found between FA vs TRA in terms of procedure time (50.0±28.9 vs 46.8±25.1 minutes, p=0.50) or length of stay (2.2±0.6 vs 2.1±0.3 days, p=0.24). While there were no strokes, access site complications occurred in 6.0% of the FA patients vs 3.7% of the TRA patients (p=0.12). CONCLUSION: The transradial approach for aortoiliac and femoropopliteal interventions is safe and efficacious compared with the transfemoral approach for a range of lesion subtypes. Nevertheless, there remains a need for improvements in peripheral device and catheter technology to decrease transradial failure rates.

Post trans-catheter aortic valve replacement shock: Back to the basics.

Transcatheter aortic valve replacement (TAVR) is indicated for the treatment of patients with severe aortic stenosis (AS) at low, intermediate, and high risk. Immediate complications post-TAVR that lead to hemodynamic compromise include: retroperitoneal bleeding, aortic dissection or rupture, pericardial tamponade, coronary ostial obstruction, acute severe central or paravalvular regurgitation, heart block, and suicide left ventricle. The presence of significant paravalvular leak (PVL) after TAVR is now an uncommon complication with newer generation devices. We present a case of an 82-year-old frail female patient who presented to our clinic with dyspnea upon minimal exertion and orthopnea. She was found to have severe AS that was treated with TAVR. The procedure was complicated by hemodynamic compromise due to severe PVL and left ventricular outflow tract (LVOT) obstruction which was underestimated by transthoracic echocardiography. The PVL was eventually treated with a vascular plug device and the LVOT obstruction was treated with alcohol septal ablation. This case highlights the vital role of early and aggressive work up in unstable patients post-TAVR and the importance of transesophageal echocardiography in patients with unexplained hypotension post-TAVR to unmask the severe PVL and dynamic LVOT obstruction. .

Structural valve deterioration of the Labcor Dokimos aortic prosthesis: a single-centre experience.

OBJECTIVES: The goal of this study was to assess the performance and incidence of the deterioration of the Labcor Dokimos bioprosthetic aortic valve. METHODS: We performed a retrospective medical chart review of 116 patients who underwent surgical aortic valve replacement with the Labcor Dokimos aortic valve between 2010 and 2018. Abstracted data included patient demographic and echocardiographic data. Patients were divided into 2 groups: patients with structural valve deterioration (SVD) and patients without SVD. RESULTS: Among the patients with complete follow-up (n = 95), 10 patients were excluded because they died within a year; 85 patients were included in the final analysis. Of the 85 patients, 32 (38%) developed SVD; 22 (26%) had severe SVD, 15 (18%) of whom underwent reintervention. The most common aetiology of SVD was severe central aortic regurgitation, which was detected in 91% of the patients who had severe SVD. The average time from operation to severe SVD was 4.7 years with a minimum of 1.5 years and a maximum of 7.9 years. CONCLUSIONS: Bioprosthetic aortic valve deterioration due to severe aortic regurgitation is common and occurs early with the Labcor Dokimos valve. This occurrence needs to be furthered investigated in larger registries.

The effects of caloric restriction on health and longevity.

OPINION STATEMENT: There is increasing evidence that restricting caloric intake may have considerable health benefits in humans. Significant evidence in non-primate animals demonstrates that caloric restriction increases average and maximal life span. However, historically, caloric intake reduction in humans has been involuntary and accompanied by poverty, malnutrition, poor sanitation, and a lack of modern health care. As a result, caloric restriction in people typically has been accompanied by a reduction of both average and maximal life span. Conversely, improvements in standards of living usually are accompanied by an increased food supply and resultant improved health and longevity. The majority of the world is now in a new era where an abundance of caloric intake and its associated obesity are causing widespread chronic illness and premature death. What would happen if one were to institute caloric restriction with high-quality nutrition within an environment of modern sanitation and health care? This review argues that improved health and improved average life span would quite likely result. A lengthening of maximal human life span with this combination is perhaps possible but by no means certain.

Intravascular Lithotripsy-Assisted Transfemoral TAVI: The Copenhagen Experience and Literature Review.

Transcatheter aortic valve implantation (TAVI) is currently an established therapy for elderly patients with symptomatic severe aortic valve stenosis across all surgical risk categories. Access is an important aspect when planning for and performing TAVI. The superiority of a transfemoral (TF) approach compared to a transthoracic (transapical, direct aortic) approach has been demonstrated in several studies. Recently, the introduction of intravascular lithotripsy (IVL) has made it possible to treat patients with calcified iliofemoral disease by TF approach. This article aimed to provide a comprehensive overview on the following aspects: (1) preprocedural planning for IVL-assisted TF-TAVI; (2) procedural aspects in IVL-assisted TF-TAVI; (3) outcomes of IVL-assisted TF-TAVI in an experienced TAVI center; and (4) literature review and discussion of this new emerging approach.

First Report of Supra-Annular Atrially Placed Bioprosthetic Mitral Valve Leak Closure Through Percutaneous Approach.

An 81-year-old man underwent mitral valve replacement in 2015 for severe calcific mitral stenosis with multiple subsequent hospitalizations for pulmonary edema. TEE in 2019 revealed severe paravalvular regurgitation. This is the first reported case of suprannular atrially placed mitral paravalvular leak closure.

New-generation drug-eluting stents for left main coronary artery disease according to the EXCEL trial enrollment criteria: Insights from the all-comers, international, multicenter DELTA-2 registry.

BACKGROUND: Percutaneous coronary intervention (PCI) has been established as an alternative treatment option to coronary artery by-pass graft (CABG) surgery in patients with left main coronary artery disease (LMCAD). Whether the findings of randomized controlled trials are applicable to a real-world patient population is unclear. METHODS: We compared the outcomes of PCI with new-generation DES in the all-comer, international, multicenter DELTA-2 registry retrospectively evaluating mid-term clinical outcomes with the historical CABG cohort enrolled in the DELTA-1 registry according to the EXCEL key inclusion or exclusion criteria. The primary endpoint was the composite of death, myocardial infarction, or stroke at the median time of follow-up time of 501 days. The consistency of the effect of DELTA-2 PCI versus DELTA-1 CABG according to the EXCEL enrollment criteria was tested using propensity score-adjusted Cox regression models. RESULTS: Out of 3986 patients enrolled in the DELTA-2 PCI registry, 2418 were EXCEL candidates and 1568 were not EXCEL candidates. The occurrence of the primary endpoint was higher among non-EXCEL candidates compared with EXCEL candidates (15.4% vs. 6.9%; hazard ratio 2.52; 95% confidence interval 2.00-3.16; p < 0.001). Among 901 patients enrolled in the historical DELTA-1 CABG cohort, 471 were EXCEL candidates and 430 were not EXCEL candidates. When comparing the DELTA-2 PCI with the DELTA-1 CABG cohort, the occurrence of the primary endpoint was lower in the PCI group compared with the historical CABG cohort among EXCEL candidates (6.9% vs. 10.7%; adjusted hazard ratio: 0.65; 95% confidence interval: 0.45-0.92), while no significant difference was observed among non-EXCEL candidates (15.4% vs. 12.5%; adjusted hazard ratio: 0.94; 95% confidence interval: 0.67-1.33) with evidence of statistical interaction (adjusted interaction p-value = 0.002). CONCLUSIONS: In a real-world population, PCI can be selected more favorably as an alternative to CABG in patients fulfilling the enrollment criteria of the EXCEL trial.

Usefulness of Transcatheter Aortic Valve Implantation for Treatment of Pure Native Aortic Valve Regurgitation.

Patients with pure native aortic valve regurgitation (NAVR) and increased surgical risk are often denied surgery. This retrospective study aimed to evaluate the "off-label" use of transcatheter heart valves (THV) for the treatment of NAVR. A total of 254 high surgical risk patients with NAVR (age 74 ± 12 years, Society of Thoracic Surgeons risk score 6.6 ± 6.2%) underwent transcatheter aortic valve implantation (TAVI) with early generation (43%) or newer generation (57%) devices at 46 different sites. Device success was significantly higher in patients treated with newer as compared with early generation THV (82% vs 47%, p <0.001). The difference was driven by lower rates of device malpositioning (9% vs 33%) and aortic regurgitation (AR) ≥ moderate (4% vs 31%) and translated into higher clinical efficacy at 30 days in patients treated with newer as compared with early generation THV (72% vs 56%, p = 0.041). Both THV under- and oversizing were associated with an increased risk of THV malpositioning. In conclusion, TAVI is a feasible treatment strategy in selected high-risk patients with NAVR but is associated with a considerable risk of THV malpositioning and residual AR. Although newer-generation THV are associated with better outcomes, novel devices for the treatment of NAVR are warranted.

Alcohol Septal Ablation for Hypertrophic Obstructive Cardiomyopathy: Indications, Technical Aspects, and Clinical Outcomes.

Hypertrophic cardiomyopathy is the most common genetically transmitted heart disease. Around two-thirds of patients develop symptoms caused by the dynamic left ventricular outflow tract obstruction, either at rest or during effort. For patients with hypertrophic obstructive cardiomyopathy (HOCM) that remain symptomatic despite optimal medical treatment, septal reduction is a valuable therapeutic strategy. While surgical myomectomy was considered the gold standard until the end of the 1990s, alcohol septal ablation (ASA) has gained rapid popularity and acceptance, especially in Europe. In this review, we describe indications and contraindications to ASA, along with technical considerations related to the procedure. Particular emphasis is put on adjunctive imaging modalities required for proper patient selection (echocardiography, magnetic resonance imaging) and procedure safety (echocardiography). Next, we describe postprocedural care and potential procedural complications. Finally, a review of the recent literature describing the long-term results of ASA is presented. In short, when performed by an experienced team, ASA has a high success rate and low complication rate. The procedure provides symptom relief and grants patients similar longevity to that of the general population.

Expert Opinion Will PARTNER 2 Change My Practice?

Transcatheter aortic valve implantation (TAVI) has become an established and increasingly-used technique to treat patients with severe aortic valve stenosis (AS) over the past decade. The clinical outcomes obtained with TAVI have been found to be equivalent to surgical aortic valve replacement (SAVR) in patients with a high-risk profile. Following the Placement of Aortic Transcatheter Valves (PARTNER) 1 trial, which demonstrated the utility of TAVI in inoperable and high-risk groups, the PARTNER 2 trial was implemented. PARTNER 2 reflects the current TAVI practice in Europe, confirms that transfemoral access is related to superior outcomes compared to SAVR in a selected population and demonstrates improved results with new-generation devices.