Safety, feasibility, and incremental value of ultralow and zero contrast PCI in an all-comers registry.

BACKGROUND: Patients with chronic kidney disease and CAD have been denied revascularization because of fear of precipitating acute renal failure from contrast exposure. Skepticism on whether Ultra-Low contrast percutaneous coronary intervention (PCI) or Zero contrast PCI (ULC/ZC PCI) can be safely performed has limited its adoption. METHODS: This observational registry enrolled 200 consecutive patients referred for elective PCI at a single center from June 2021 to December 2022. The study investigated whether the clinical outcomes of PCI performed with UL/ZC-PCI (n-48) were comparable to outcomes following standard PCI (n-152). RESULTS: Both groups were well matched in baseline and procedural characteristics. The groups had a highly statistical difference in the use of CV. Mean CV was 19.17 ± 7.29 cc in the ULC/ZC-group and 147.14 ± 73.55 cc in the control arm. The principal findings of the study were that the incidence of ontrast-induced acute kidney injury (AKI) was eightfold lower in patients receiving UL/ZC compared to the control group that received standard PCI. The incidence of all-cause mortality, myocardial infarction and major bleeding were similar in both groups. At 6 months, the decrement in renal function was lower in the group that received lower volumes of contrast. CONCLUSIONS: This single center observational registry demonstrated that UL-C/ZC-PCI is safe and effective in a broad spectrum of complex lesions. The skillsets needed to perform this are teachable, widely applicable and do not require a large upgrade of capital equipment. AKI rates and decrement in renal function at 6 months were both significantly lower in the UL-ZC group.

Optimal timing of staged percutaneous coronary intervention after subintimal tracking and re-entry: Rationale and design of the subintimal tracking and re-entry with deferred stenting study.

BACKGROUND: Ten to fifteen percent of chronic total occlusion (CTO) percutaneous coronary interventions (PCIs) are unsuccessful in contemporary practice. Subintimal tracking and re-entry (STAR) (one form of "investment procedure") with staged reattempt and stenting may further increase the ultimate success and safety of CTO as a bailout strategy. The optimal timing for staged stenting after STAR is unknown. METHODS AND RESULTS: We designed a six-center, prospective randomized trial with a planned enrollment of 150 patients where STAR is utilized in case of impending failure. The primary aim is to evaluate the optimal timing of the staged PCI after STAR by randomizing the timing to earlier (5-7 weeks) versus later (12-14 weeks) staged PCI. The primary endpoint of the study is the technical success rate of the staged procedure. The secondary endpoints include: (1) the rate of thrombolysis in myocardial infarction 3 flow at the start of staged intervention, (2) rate of partial technical and procedural success of the staged procedure, (3) rate of in-hospital and 12-month major cardiac and cerebrovascular adverse events, and (4) change in patient-reported quality at 30 days, 6 months, and 12 months assessed by Seattle Angina Questionnaire. CONCLUSION: This study will ascertain the optimal timing of staged stenting after bail-out STAR approach in contemporary CTO PCI (ClinicalTrials.gov NCT05089864).

Embolization of percutaneous left atrial appendage closure devices: Timing, management and clinical outcomes.

BACKGROUND: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. OBJECTIVES: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. METHODS: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. RESULTS: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients. CONCLUSIONS: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful. CONDENSED ABSTRACT: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high.

White paper on mitigating risk factors for acute kidney injury in TAVR: A protocol to decrease TAVR-associated AKI.

Acute kidney injury (AKI) after transcatheter aortic valve replacement (TAVR) portends a poor prognosis. In the TVT registry, AKI after TAVR occurred in 10% of the patients. The etiology of AKI after TAVR is multifactorial but contrast volume remains one of the few modifiable risk factors. As patients referred for TAVR have multiple touch points within a siloed healthcare system, there remains an unmet clinical need of a well-defined clinical pathway to minimize the risk of AKI from the time of referral for TAVR to the completion of the procedure. This white paper aims to provide such a clinical pathway.

Utilization of Non-Drug-Eluting Devices for Inpatient Percutaneous Coronary Intervention in the United States.

There is a paucity of data on the contemporary use of non-drug-eluting devices (balloon angioplasty or bare-metal stents) in contemporary percutaneous coronary intervention (PCI) in the United States. We utilized the Nationwide Readmissions Database to identify patients hospitalized to undergo PCI with non-drug-eluting devices from 2016 to 2019. The main outcome of interest was the trends in utilization over the study years. Among 1,870,262 PCI procedures, 127,810 (6.8%) were performed with non-drug-eluting devices; 72% of these were in the setting of acute myocardial infarction (MI). The use of non-drug-eluting devices decreased throughout the study period from 12.9% of all PCI in the first quarter of 2016 to 3.4% in the last quarter of 2019 (p <0.001). Factors associated with their use included advanced age and high bleeding risk. Only a small percentage were used as a bridge to coronary artery bypass graft surgery (2%) and for treatment of in-stent restenosis (3%). The in-hospital mortality was 5.8% for the entire cohort and 6.6% when the indication for use was an acute MI. In patients presenting with an acute MI, reinfarction within 30 days was common and occurred in 18% of the patients. In conclusion, the use of non-drug-eluting devices in PCI in the United States decreased from 2016 to 2019. Factors associated with their use included old age and high bleeding risk. Due to suboptimal outcomes in patients currently being treated with non-drug-eluting devices, there remains an unmet clinical need for alternative treatment options.

The impact of pulmonary hypertension on outcomes of transcatheter mitral valve replacement in mitral annular calcification.

OBJECTIVES: To assess the impact of pulmonary hypertension (PH) on outcomes of patients with severe mitral annular calcification (MAC) undergoing transcatheter mitral valve replacement (TMVR). BACKGROUND: PH is associated with poor outcomes after mitral valve surgery. Whether the presence of PH in patients with MAC undergoing (TMVR) is associated with poor outcomes, is unknown. METHODS: Retrospective evaluation of 116 patients from 51 centers in 11 countries who underwent TMVR with valve in mitral annular calcification (ViMAC) using balloon-expandable aortic transcatheter valves (THVs) from September 2012 to March 2017. Pulmonary artery systolic blood pressure (PASP) by echocardiogram was available in 90 patients. The subjects were stratified based on PASP: No PH = PASP ≤35 mmHg (n = 11); mild to moderate PH = PASP 36-49 mmHg (n = 21) and severe PH = PASP ≥50 mmHg (n = 58). Clinical, procedural, and echocardiographic outcomes were assessed. RESULTS: Mean age was 72.7 (±12.8) years, 59 (65.6%) were female, Society of Thoracic Surgeons score was 15.8 + 11.8% and 90.0% where in New York Heart Association (NYHA) class III-IV. There was no significant difference in all-cause mortality at 30 days (no PH = 27.3%, mild-moderate PH = 19.0%, severe PH = 31.6%; p = 0.55) or at 1 year (no PH = 54.5%, mild-moderate PH = 38.1%, severe PH = 56.1%; p = 0.36). No difference in adverse events, NYHA class or amount of residual mitral regurgitation at 1 year were observed between the groups. CONCLUSION: This study suggests that the presence of PH in patients with predominantly mitral stenosis with MAC undergoing TMVR does not impact mortality or adverse events. Further studies are needed to fully understand the effect of PH in this group of patients.

Percutaneous extraction of a large device-related thrombus on a Watchman™ device: a case report.

BACKGROUND: Left atrial appendage occlusion devices are commonly used to prevent stroke in patients with persistent atrial fibrillation who are unable to tolerate anticoagulation. However, certain patient- and device-related characteristics increase the risk for the development of a device-related thrombus (DRT). The presence of a DRT increases the risk of stroke and should be treated. Management of DRT lacks consensus but is mostly focused on anticoagulation. In patients with large thrombi that need to be managed urgently, percutaneous extraction may be a viable option. CASE SUMMARY: In this report, we describe the successful management of a DRT via percutaneous thrombus extraction technology in an 81-year-old woman with a large thrombus attached to a WATCHMAN™ device. The patient initially presented with shortness of breath, and on imaging a pedunculated thrombus was detected. The thrombus was extracted using a Penumbra Lightning 12™ (Penumbra Inc., Alameda, CA, USA) catheter with a Sentinel™ (Boston Scientific, Marlborough, MA, USA) cerebral embolic protection device. The patient had no neurologic sequelae and was started on anticoagulation. DISCUSSION: Percutaneous thrombectomy can be safely performed to extract large left atrial occlusion DRT that require urgent management, without any neurologic sequelae. We believe this can be used in patients with a large DRT who would not be adequately managed with anticoagulation and in whom surgery is not feasible.

Complications of the MANTA Closure Device: Insights From MAUDE Database.

BACKGROUND: The collagen-based MANTA device (Teleflex, PA, USA) is used for closure of large-bore vascular access. There is a paucity of data on complications associated with its use in a real-life setting. METHODS: We queried the "Manufacturer and User Facility Device Experience" MAUDE database between February 2019 and December 2020 for reports on MANTA device. RESULTS: We identified 250 reports in the MAUDE database from February 2019 through December 2020. The most common failure complication of MANTA is persistent bleeding (48.8%) and vessel occlusion or stenosis (29.6%). Most complications were managed successfully with an endovascular approach (48.4%), but a high number of patients required surgical intervention (40.4%). The most commonly reported failure mechanism was the failure of deployment (22%) followed by subcutaneous deployment (7.6%), intraluminal deployment (4.8%) amd detachment of collagen (2.8%). Access site infection was rare (1.2%). The 18 Fr. MANTA was associated with a lower risk of failure of deployment compared with the 14 Fr. device but was associated with a higher risk of vessel occlusion or stenosis (32.4% vs. 16.3%, p = 0.04) and thrombosis (11.6% vs 0%, p = 0.03). CONCLUSIONS: The most common complication of the MANTA device reported to the MAUDE registry was persistent bleeding (48.8% of reports) followed by vessel occlusion (29.6%). These complications were managed successfully using an endovascular approach in 48.4% of the reports.

Complications and Failure Modes of Polymer-Jacketed Guidewires; Insights From the MAUDE Database.

BACKGROUND: The modes of failure of coronary polymer-jacketed guidewires have received limited study. METHODS: We queried the Manufacturer and User Facility Device Experience (MAUDE) database between January 2011 and December 2020 for reports on coronary polymer-jacketed guidewires and retrieved 254 reports. RESULTS: The most common failure mode was failure of the guidewire to cross (36.2%), followed by guidewire fracture (35%), peeling of the polymer jacket (13.8%), failure to retrieve the guidewire (13.8%), and guidewire unraveling (4.7%). Guidewire fracture was more common with soft (37.3%) compared with stiff (23.8%) guidewires. Failure of retrieval was only reported with soft guidewires (9%). Coronary perforation and dissection occurred in 19.7% and 7.9% of the reports, with more reports with stiff as compared with soft guidewires (45.2% vs. 14.6% for perforation and 21.4% vs. 5.3% for dissection). CONCLUSIONS: The most common failure modes of polymer-jacketed guidewires during percutaneous coronary intervention are failure to cross the lesion, guidewire fracture, and peeling of the polymer jacket. Coronary perforations were more common with stiff whereas wire fracture was more common with soft polymer-jacketed guidewires.