Effectiveness and Safety of an Outpatient Program for Percutaneous Left Atrial Appendage Occlusion.

BACKGROUND: Left atrial appendage occlusion (LAAO) is a safe and effective alternative to oral anticoagulation for thromboprophylaxis in patients with nonvalvular atrial fibrillation. Technological development in devices and imaging techniques, as well as accumulated experience, have increased procedural success rates and decreased complications. Same-day discharge protocols have been proposed in the field of structural heart disease, but this approach has not been studied in detail for the LAAO procedure. AIM: The aim of this study is to assess the safety and efficacy of an outpatient program for LAAO when compared to the conventional treatment approach. METHODS: We present a retrospective, non-randomized single-center study of 262 consecutive patients undergoing LAAO. Patients were divided into two groups, the first (n = 131) followed a conventional protocol (CP), and the second (n = 131) an outpatient protocol (OP). The primary composite endpoint comprised MACCE (death, stroke, and bleeding), cardiac tamponade, vascular complication, or attendance in the emergency department after hospital discharge at 30 days. RESULTS: The overall success rate was 99.6%, with a periprocedural complication rate of 2.29%. With regards to the CP versus OP group, there were no differences between incidences of the primary composite endpoint (6.1% PC vs. 3.0% PA, p = 0.24), or after an analysis, with propensity score matching. No differences were observed in the individual endpoints. There was a decrease in hospital length of stay in the same-day discharge group (p < 0.01). CONCLUSIONS: A same-day discharge LAAO program is safe, effective, and feasible when compared to the conventional strategy. Moreover, it reduces hospital length of stay, which might have clinical and economic benefits.

The use of deformation imaging in the assessment of patients pre and post transcatheter aortic valve implantation.

BACKGROUND: Deformation imaging represents a method of measuring myocardial function, including global longitudinal strain (GLS), peak atrial longitudinal strain (PALS) and radial strain. This study aimed to assess subclinical improvements in left ventricular function in patients undergoing transcatheter aortic valve implantation (TAVI) by comparing GLS, PALS and radial strain pre and post procedure. METHODS: We conducted a single site prospective observational study of 25 patients undergoing TAVI, comparing baseline and post-TAVI echocardiograms. Individual participants were assessed for differences in GLS, PALS and radial strain in addition to changes in left ventricular ejection fraction (LVEF) (%). RESULTS: Our results revealed a significant improvement in GLS (mean change pre-post of 2.14% [95% CI 1.08, 3.20] p = 0.0003) with no significant change in LVEF (0.96% [95% CI - 2.30, 4.22], p = 0.55). There was a statistically significant improvement in radial strain pre and post TAVI (mean 9.68% [95% CI 3.10, 16.25] p = 0.0058). There was positive trend towards improvements in PALS pre and post TAVI (mean change of 2.30% [95% CI - 0.19, 4.80] p = 0.068). CONCLUSION: In patients undergoing TAVI, measuring GLS and radial strain provided statistically significant information regarding subclinical improvements in LV function, which may have prognostic implications. The incorporation of deformation imaging in addition to standard echocardiographic measurements may have an important role in guiding future management in patients undergoing TAVI and assessing response.

Intravascular lithotripsy-assisted PCI for severely calcified coronary lesions: evaluating the impact on quality of life and outcomes.

BACKGROUND: Despite the increased uptake of intravascular lithotripsy (IVL) for treating severely calcified coronary lesions, there is limited patient-level data examining the effect of IVL on quality of life, symptomatology, and outcomes beyond 30 days. We sought to assess demographics, procedural characteristics, outcomes, and impact of IVL on patient-reported angina after a minimum of 6 months follow-up. METHODS: A retrospective single-center study was conducted of patients treated with coronary IVL between January and October 2020. Baseline demographics were obtained from electronic patient records and SYNTAX scores were calculated from index coronary angiograms. Technical success and complications were assessed along with clinical outcomes, which included all-cause mortality, myocardial infarction (MI), target lesion revascularization (TLR), and MACE (composite of death, stroke, MI, and TLR). Canadian Cardiovascular Society (CCS) angina classification was assessed at virtual clinical follow-up. RESULTS: Forty-seven consecutive patients were included. At a mean follow-up of 306 ± 74 days, the mean CCS angina score was reduced by 53% post-IVL-assisted PCI (2.9 vs 1.4, p < 0.001). Technical and procedural success were high (94% and 92%, respectively). One patient (2%) met the pre-specified criteria for in-hospital MACE and 4 (9%) met pre-specified MACE at follow-up, including 2 deaths and 2 TLR. Procedural complications included coronary dissection (11%) and coronary perforation (6%) and were managed either conservatively or with PCI. CONCLUSIONS: Coronary IVL is a safe and effective adjunctive therapy for treating heavily calcified coronary lesions. This cohort shows high procedural success and a significant reduction in CCS angina at follow-up.

A case report of ventricular septal defect complicating transcatheter aortic valve implant for aortic regurgitation: novel complication and technical considerations.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has proven efficacy in the treatment of aortic stenosis (AS). Understandably, there is increasing enthusiasm for its use to treat aortic regurgitation (AR). However, there are significant anatomical differences between AS and AR which make TAVI for AR more complex. CASE SUMMARY: We present the case of technically challenging TAVI for severe AR, which was complicated by a traumatic ventricular septal defect (VSD) that required percutaneous closure. To our knowledge, this is the first published case of VSD post-TAVI for AR. DISCUSSION: This unanticipated complication highlights anatomical differences between TAVI use in AS and AR. Lack of aortic valve calcification and excessive annular compliance made stable deployment of a self-expanding valve extremely challenging. Despite device oversizing, repeated embolization of the prosthesis into the left ventricular outflow tract traumatized the interventricular septum.

Impaired autonomic function after incomplete revascularisation.

INTRODUCTION: Incomplete cardiac revascularisation (ICR) assessed by residual SYNTAX score (rSs) is associated with increased 5-year mortality. Furthermore, in the general population, our group has demonstrated that impaired autonomic function determined by heart rate recovery time between 10 and 20 s (HRR10-20) following an active stand is associated with increased all-cause mortality. PURPOSE: We hypothesised that ICR would be associated with impaired autonomic function determined by HRR10-20. METHODS: After ethical approval and informed consent, consecutive patients attending cardiac rehabilitation in a tertiary referral centre were enrolled. All patients had percutaneous coronary revascularisation. During an active stand, real-time heart rate, blood pressure and ECG recordings were taken using non-invasive digital photoplethysmography and HRR10-20 determined. Assessment of autonomic function was performed by determining speed of HRR10-20 post-orthostatic challenge.Patients with an rSs >0 were considered incompletely revascularised and those with an rSs of 0 fully revascularised. Demographic data were recorded and statistical analysis performed. RESULTS: Patients (n=53) comprised those with complete revascularisation (CR) (n=37) and ICR (n=16). In the ICR group, mean rSs was 9.4.HRR10-20 was impaired in the ICR group (-3±0.60) compared with the CR cohort (-6.56±0.52) (p<0.0001). Completeness of revascularisation was strongly associated with HRR10-20 (Pearson's correlation coefficient 0.529; p<0.0001). Baseline demographics did not differ significantly. Use of rate-limiting medication was similar between cohorts (beta blockers, calcium channel blockers, ivabradine). CONCLUSIONS: Our data confirm significant correlation between ICR and impaired autonomic function determined by speed of heart rate recovery. Thus, determining autonomic dysfunction post-ICR may identify those at increased mortality risk.

Real-World Experience With Antiplatelet Agents After Percutaneous Coronary Intervention in Patients With an Indication for an Oral Anticoagulant.

ABSTRACT: Patients undergoing percutaneous coronary intervention (PCI) with a clinical indication for oral anticoagulation (OAC) in addition to antiplatelet therapy (APT) necessitate rigorous evaluation of bleeding and ischemic risk to guide therapy. The optimal OAC/APT drug combination and duration of treatment is not known. This study aimed to evaluate the incidence of patients undergoing PCI with an OAC indication and the rationale for post-PCI combined OAC/APT selection in clinical practice. Consecutive patients undergoing PCI with an indication for combined OAC/APT were included in a 12-month retrospective case series. Patient demographics, clinical characteristics, prescribed OAC/APT regimens, and rationale for drug selection were reviewed. PCI was performed in 1650 patients during the study period, with an indication for OAC/APT in 133 (8.1%). A combination of aspirin, P2Y12 inhibitor, and OAC was the most frequently prescribed regime on discharge (n = 103, 81%). Dual antiplatelet therapy (DAPT) in combination with OAC was continued for a mean duration of 6.4 ± 4.4 weeks (range 3-52 weeks) before one antiplatelet was discontinued. There was no significant difference between the mean CHA2DS2-VASc or HAS-BLED score of patients with atrial fibrillation discharged on OAC/DAPT compared with alternate combinations (DAPT alone or OAC/single APT), 3.6 ± 1.3 versus 3.8 ± 1, P = 0.37 and 2.04 ± 0.7 versus 2.05 ± 1.0, P = 0.98, respectively. This case series identifies high variability in OAC/APT treatment duration and limited application of risk scoring systems and high-risk PCI characteristics in the selection of OAC/APT regimens. A more systematic patient assessment is needed to help standardize OAC/APT prescribing for this important patient cohort.

Late ventricular standstill following an elective TAVI.

Transcatheter aortic valve implantations (TAVIs) may be complicated by a need for permanent pacemaker implantation post procedure, usually due to local trauma or compression on the conduction system. There are some features that might help predict that a patient is high risk for developing conduction disease following TAVI, for example, underlying right bundle branch block or use of certain types of TAVI. It might also become apparent during the procedure, or before temporary wire removal post procedure. Higher risk patients may undergo rhythm monitoring for longer periods post TAVI. We present a case where a patient required an unexpected emergency pacemaker following a TAVI, despite low risk clinical features, a low risk baseline ECG, and the use of a low risk TAVI valve. In addition, this very significant conduction disease only became apparent over 72 hours following implantation, despite normal resting ECGs and telemetry up to that point.

Impact of genetic variation in the 5-HT transporter and receptor on platelet function in patients with stable CAD taking aspirin.

BACKGROUND: Serotonin (5-HT) induces platelet aggregation by activating its 5-HT2A receptor. Platelet uptake is mediated by the 5-HT transporter (5-HTT). A common 5-HTT promoter (5-HTTLPR) splice variant results in long (L) and short (S) alleles. 5-HTTLPR genotype has been associated with increased platelet activation and risk of MI. Variation within HTR2A gene (C1354T) that encodes the 5-HT2A receptor has also been associated with enhanced platelet aggregation. We hypothesised that 5-HTT and/or HTR2A variation may influence platelet response to aspirin in patients with stable CAD. METHODS: Patients (n=144) with stable cardiovascular disease taking aspirin were genotyped for the 5-HTTLPR and HTR2A variants. Platelet inhibition was assessed by serum thromboxane and arachidonic acid-induced platelet aggregation assay. RESULTS: 5-HTT genotype (LL vs *S) was a significant determinant of serum TX level (8.9±2.6ng/ml vs 6.0±1.6ng/ml respectively; p<0.02) and 5-HTT LL genotype predicted an incomplete aspirin response (serum TXB2>2.2ng/ml) (p=0.04; OR=2.22, CI=1.03-4.79). Odds ratio of the effect of LL genotype on TX elevation was 3.8 (95% CI 1.2-11.6) in younger patients (under 64) compared to 1.0 (95% CI=0.3-3.8) in older subjects. LL genotype did not influence AA aggregation (p=0.83, OR=1.2, CI=0.3-4.1). The HTR2A variant had no effect on TX generation (p=0.70; OR=1.22, CI=0.45-3.26) nor AA aggregation (p=0.99; OR=1.0, CI=0.2-4.9). CONCLUSIONS: In younger patients with stable CAD 5HTT LL genotype carried by almost one third of our cohort is associated with a diminished response to aspirin that may increase cardiovascular risk. Genotypic variation in platelet activation may be a contributing mechanism.

Renal insufficiency, bleeding and prescription of discharge medication in patients undergoing percutaneous coronary intervention in the National Heart, Lung, and Blood Institute (NHLBI) Dynamic Registry.

AIMS: To establish the relationship between renal insufficiency, bleeding and prescription of cardiovascular medication. METHODS AND RESULTS: This was a prospective, multi-center, cohort study of consecutive patients undergoing PCI during three NHLBI Dynamic Registry recruitment waves. Major and minor bleeding, access site bleeding and rates of prescription of cardiovascular medication at discharge were determined based on estimated glomerular filtration rate (eGFR). Renal insufficiency was an independent predictor of major adverse cardiovascular events (MACE). Bleeding events and access site bleeding requiring transfusion were significantly associated with degrees of renal insufficiency (p<0.001). There was an incremental decline in prescription of cardiovascular medication at discharge proportionate to the degree of renal impairment (aspirin, thienopyridine, statin, coumadin (overall p<0.001), beta blocker (overall p=0.003), ACE inhibitor (overall p=0.02). Bleeders were less likely to be discharged on a thienopyridine (95.4% versus 89.9% for bleeding, p<0.001 and 95.3% versus 87.9% for access site bleeding, p=0.005), but not aspirin (96.3% versus 96.2%, p=0.97 and 96.3% versus 93.6%, p=0.29 respectively). Failure to prescribe anti-platelet therapy at discharge was strongly associated with increased MACE at one year. CONCLUSIONS: Renal insufficiency is associated with bleeding in patients undergoing PCI. Patients with renal insufficiency are less likely to receive recommended discharge pharmacotherapy.

Point-of-care platelet function testing predicts bleeding in patients exposed to clopidogrel undergoing coronary artery bypass grafting: Verify pre-op TIMI 45--a pilot study.

BACKGROUND: Guidelines recommend delaying coronary artery bypass grafting (CABG) for 5 days after discontinuing clopidogrel. However, platelet function may recover quicker in certain individuals. HYPOTHESIS: We hypothesized that perioperative measurement of platelet function with a point-of-care P2Y12 inhibitor assay could predict bleeding during CABG in patients exposed to clopidogrel. METHODS: Verify Pre-Op TIMI 45 was a prospective pilot study of 39 patients on clopidogrel who subsequently underwent CABG. Preoperative on-treatment platelet reactivity was assessed with VerifyNow P2Y12 Reaction Units (PRU), with higher PRU indicating more reactive platelets. Outcomes were stratified by PRU quartiles, as well as prespecified cutpoints for the lowest quartile (PRU 173), a cutpoint for major bleeding determined by the Youden index using receiver operator curve analysis (PRU 207), and clopidogrel resistance (PRU 230). RESULTS: Patients in higher PRU quartiles experienced smaller decreases in hemoglobin and hematocrit (P < 0.05 for all comparisons), less major bleeding (P = 0.021), and less major or minor bleeding (P = 0.003). Patients above the PRU 207 and 230 cutpoints had less chest-tube output (P = 0.041 and P = 0.012, respectively), less major bleeding (P = 0.005 and P = 0.036, respectively), and less major or minor bleeding (P = 0.013 and P < 0.001, respectively). By receiver operator curve analysis, preoperative PRU ≤ 207 discriminated between patients with and without major bleeding during surgery (area under the curve: 0.76, 95% confidence interval: 0.59-0.94, P = 0.018). CONCLUSIONS: In this pilot study, we found that point-of-care platelet function assessment could predict bleeding in patients recently exposed to clopidogrel undergoing CABG.

Significance of the learning curve in left atrial appendage occlusion with two different devices.

OBJECTIVE: To evaluate the impact of learning on outcome with use of two different left atrial appendage (LAA) occlusion devices. BACKGROUND: Two self-expanding devices, the Watchman and the Amplatzer Cardiac Plug (ACP), have been used for LAA occlusion in the last few years. It has been demonstrated that complications associated with implantation decrease in frequency with operator experience. However, the role of operator experience has not been compared across the two device types. METHODS: The study comprises 31 consecutive patients who underwent LAA occlusion. We compare the first 10 patients in whom an ACP was implanted with the subsequent eleven patients who underwent ACP implantation and with 10 cases where a Watcthman device was implanted. The composite safety end point comprised procedure-related events and excessive bleeding events. We also performed 3 months echocardiographic and clinical follow-up. RESULTS: There were not significant differences in the basal clinical and echocardiographical characteristics across the three groups. Cardiac complications only occurred in the ACP initial experience group (9% vs. 0% vs. 0% P = 0.04). Echocardiographic and clinical follow-up at 3 months was completed in all patients. No significant residual leak was detected. One patient in the ACP initial experience group developed a thrombus on the device. One patient in ACP late experience presented an ischemic stroke. CONCLUSIONS: Complications associated with LAA occlusion cluster early in the peri-procedural period and significantly decrease in frequency with operator experience. Initial experience gained with one of device may improve outcome with use of alternative LAA occlusion devices.

Effect of elevated pulmonary vascular resistance on outcomes after percutaneous mitral valvuloplasty.

Patients with mitral stenosis with severe pulmonary hypertension constitute a high-risk subset for surgical commissurotomy or valve replacement. The aim of the present study was to examine the effect of elevated pulmonary vascular resistance (PVR) on percutaneous mitral valvuloplasty (PMV) procedural success, short- and long-term clinical outcomes (i.e., mortality, mitral valve surgery, and redo PMV) in 926 patients. Of the 926 patients, 263 (28.4%) had PVR ≥4 Woods units (WU) and 663 (71.6%) had PVR <4 WU. Patients with PVR ≥4 WU were older and more symptomatic and had worse valve morphology for PMV. The patients with PVR ≥4 WU also had lower PMV procedural success than those with PVR <4 WU (78.2% vs 85.6%, p = 0.006). However, after multivariate adjustment, PVR was no longer an independent predictor of PMV success nor an independent predictor of the combined end point at a median follow-up of 3.2 years. In conclusion, elevated PVR at PMV is not an independent predictor of procedural success or long-term outcomes. Therefore, appropriately selected patients with rheumatic mitral stenosis might benefit from PMV, even in the presence of elevated preprocedural PVR.

Difference in outcome among women and men after percutaneous mitral valvuloplasty.

OBJECTIVE: To analyze the differences in anatomical, clinical and echocardiographic characteristics of women and men undergoing PMV and to evaluate the relationship between sex, PMV success, and immediate and long-term clinical outcome. BACKGROUND: Rheumatic mitral stenosis (MS) is predominantly a disease of middle-aged women. Percutaneous mitral valvuloplasty (PMV) has become the standard of care for suitable patients. However little is known about the relationship between sex, PMV success, and procedural outcome. METHODS AND RESULTS: We evaluated measures of procedural success and clinical outcome in consecutive patients (839 women and 176 men) who underwent PMV. Despite a lower baseline echocardiographic score (7.47 ± 2.15 vs. 8.02 ± 2.18, P = 0.002), women were less likely to achieve PMV success (69% vs. 83%, adjusted OR 0.44, 95% CI 0.27-0.74, P = 0.002), and had a smaller post-procedural MV area (1.86 ± 0.7 vs. 2.07 ± 0.7 cm(2), P < 0.001). Overall procedural and in-hospital complication rates did not differ significantly between women and men. However, women were significantly more likely to develop severe MR immediately post PMV (adjusted OR 2.41, 95% CI 1.0-5.83, P = 0.05) and to undergo MV surgery (adjusted HR 1.54, 95% CI 1.03-2.3, P = 0.037) after a median follow-up of 3.1 years. CONCLUSIONS: Compared to men, women with rheumatic MS who undergo PMV are less likely to have a successful outcome and more likely to require MV surgery on long-term follow-up despite more favorable baseline MV anatomy.

The role of stent grafts in the management of traumatic tibial artery pseudoaneurysms: case report and review of the literature.

Tibial artery pseudoaneurysms can occur in the setting of trauma. Operative exposure and repair of these injuries can be challenging, and surgical management options include direct arterial repair, interposition grafting, or arterial ligation. Other techniques including duplex-guided compression, thrombin injection, and endovascular intervention have been described. We present the case of a 39-year-old man who sustained blunt trauma to his right lower extremity and developed a delayed symptomatic pseudoaneurysm of the posterior tibial artery. He was successfully managed with endovascular stent graft exclusion of the pseudoaneurysm. Endovascular stent-grafting techniques can be successfully applied to the management of traumatic tibial pseudoaneurysms.

Impact of pre- and postprocedural mitral regurgitation on outcomes after percutaneous mitral valvuloplasty for mitral stenosis.

Percutaneous mitral valvuloplasty (PMV) is an effective therapy in patients with significant mitral stenosis. Few studies have examined the effect of mitral regurgitation (MR), a frequent periprocedural finding, on PMV outcomes. We examined the effects of pre- and postprocedural MR after PMV. Contrast left ventriculography was performed before and after PMV, and the MR severity was assessed using Sellers' classification. Clinical, hemodynamic, and morphologic variables were collected for all patients. Consecutive patients (n = 876) undergoing a first PMV procedure at a single tertiary center were evaluated. An increasing preprocedural MR severity was associated with reduced PMV success (no MR, 75%; 1+ MR, 65%; 2+ MR, 44%; p <0.0001), increased in-hospital mortality (0.6% vs 2.8% vs 4.9%, respectively; p = 0.007), and other complications. Increasing grades of pre- and postprocedural MR predicted, independently and in a grade-dependent manner, the composite outcome of mortality, mitral valve surgery, or redo PMV (preprocedural MR >or=1+, relative risk [RR] 1.4, 95% confidence interval [CI] 1.2 to 1.8; preprocedural MR >or=2+, RR 1.6, 95% CI 1.1 to 2.4; postprocedural MR >or=1+, RR 1.6, 95% CI 1.2 to 2.0; postprocedural MR >or=2+, RR 2.2, 95% CI 1.7 to 2.7; and postprocedural MR >or=3+, RR 4.6, 95% CI 3.4 to 6.2, respectively). In conclusion, increasing pre- and postprocedural MR grades independently predicted the long-term clinical outcomes after PMV. Patients with moderate preprocedural MR, in particular, appeared to have suboptimal short- and long-term outcomes, necessitating careful monitoring and early referral for mitral valve surgery, when appropriate.