A novel approach to saline/contrast delivery in excimer laser coronary atherectomy (ELCA) to enhance efficacy: MAXCon ELCA technique.

The advent of excimer laser coronary atherectomy (ELCA) nearly four decades ago heralded a novel way to treat complex lesions, both coronary and peripheral, which were previously untraversable and thus untreatable. These complex lesions include heavily calcified lesions, ostial lesions, bifurcation lesions, chronic total occlusions, in-stent restenosis (including stent underexpansion), and degenerative saphenous vein grafts. We discuss the technology of ELCA, its indications, applications, and complications, and suggest the "MAXCon ELCA" technique for better outcomes without increased risk. Lastly, we present a case of MAXCon ELCA effectively treating a complex lesion.

Cutting balloon for femoral arterial and venus obstructions due to suture-based closure devices: Case series.

Suture-based vascular closure devices have been shown to be effective in hemostasis for procedures with vascular access. However, iatrogenic vascular occlusion may occur. The cutting balloon (CB) is a noncompliant balloon wrapped with 3-4 microsurgical blades that are intended to modify vascular lesions, but it may also be utilized to cut and release endovascular sutures. We report two cases in which the CB was employed as a bailout strategy to alleviate suture-related vascular occlusion after transcatheter aortic valve replacement. The CB can be effectively utilized to resolve suture-related vascular occlusion.

Review of Pathophysiology of Cardiogenic Shock and Escalation of Mechanical Circulatory Support Devices.

PURPOSE OF REVIEW: Cardiogenic shock (CS) is a complex clinical entity that continues to carry a high risk of mortality. The landscape of CS management has changed with the advent of several temporary mechanical circulatory support (MCS) devices designed to provide hemodynamic support. It remains challenging to understand the role of different temporary MCS devices in patients with CS, as many of these patients are critically ill, requiring complex care with multiple MCS device options. Each temporary MCS device can provide different types and levels of hemodynamic support. It is important to understand the risk/benefit profile of each one of them for appropriate device selection in patients with CS. RECENT FINDINGS: MCS may be beneficial in CS patients through augmentation of cardiac output with subsequent improvement of systemic perfusion. Selecting the optimal MCS device depends on several variables including the underlying etiology of CS, clinical strategy of MCS use (bridge to recovery, bridge to transplant or durable MCS, or abridge to decision), amount of hemodynamic support needed, associated respiratory failure, and institutional preference. Furthermore, it is even more challenging to determine the appropriate time to escalate from one MCS device to another or combine different MCS devices. In this review, we discuss the current available data published in the literature on the management of CS and propose a standardized approach for escalation of MCS devices in patients with CS. Shock teams can play an important role to help in hemodynamic-guided management and algorithm-based step-by-step approach in early initiation and escalation of temporary MCS devices at different stages of CS. It is important to define the etiology of CS, and stage of shock and recognize univentricular vs biventricular shock for appropriate device selection and escalation of therapy.

Impact of Close Surveillance on Dual-Antiplatelet Therapy Compliance in Myocardial Infarction Patients Post-Percutaneous Coronary Intervention.

BACKGROUND: Dual-antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor is the mainstay regimen for acute coronary syndrome (ACS) patients after percutaneous coronary intervention (PCI). We aimed to investigate DAPT compliance and switching patterns in ACS patients prescribed ticagrelor and aspirin. Secondly, we evaluated the impact of a pilot strategy of close surveillance telephone calls. METHODS: The study enrolled 150 consecutive ACS patients who underwent PCI and were prescribed DAPT (aspirin and ticagrelor). This cohort, the "close surveillance arm," then received telephone calls from a healthcare professional to inquire about DAPT for up to one year. These findings, and clinical outcomes, were then compared to a "historical arm" of ACS patients (n = 505) who received PCI and were prescribed DAPT before initiation of the program. Finally, healthcare providers were surveyed about their experience with prescribing DAPT. RESULTS: The rate of ticagrelor cessation trended lower in the close surveillance arm (22.00 % versus 31.70 %, p = 0.0783). The most common reasons for ticagrelor cessation were adverse medication reaction (dyspnea), bleeding, and financial burden. Nevertheless, the adverse events were few and similar between the two groups during follow-up. Over 96 % of healthcare providers surveyed stated that they worry about their patients' DAPT compliance post-PCI. CONCLUSION: Noncompliance and switching medications are still common for patients who undergo PCI for ACS. A close surveillance program identified patients at risk for medication cessation or switching and could potentially mitigate this phenomenon and improve quality of care.

Protamine-induced Acute Thrombosis in a Post-TAVR Patient: A Word of Caution.

Major vascular complications after transcatheter aortic valve replacement (TAVR) are a pertinent issue and associated with increased morbidity and mortality. We herein describe a case of acute limb ischemia following the administration of protamine sulfate (PS) that was administered to mitigate a bleeding complication post-failure of a vascular access closure device. PS should be used cautiously for the prevention or management of bleeding-site complications following TAVR. The patient described in this case has consented to having his case described in this manuscript.

Randomized Trials of Percutaneous Microaxial Flow Pump Devices: JACC State-of-the-Art Review.

The use of mechanical circulatory support devices in cardiovascular practice has risen exponentially over the past decade. These devices are currently used for hemodynamic support in patients with cardiogenic shock, high-risk percutaneous coronary intervention, left ventricular unloading, protection of kidneys, and right ventricular failure. The Impella (Abiomed) percutaneous microaxial flow pump devices are rapidly gaining popularity. However, despite their increasing use, there are limited randomized clinical trials (RCTs) to support the benefits of the therapy and growing concern regarding complication rates. Vascular problems, including bleeding and acute limb ischemia, are associated with the devices, but published reports also highlight risks for cardiac perforations, mitral chordae rupture, and stroke. In this review, we summarize the history, mechanism of action, previously published RCT data, and upcoming RCTs on these devices.

Exploiting the Transformation Temperature to Reform an Infolded Nitinol Self-Expanding Peripheral Stent.

PURPOSE: Nickel-titanium (nitinol) alloys possess a special set of properties that allow for a wide range of applications. Specifically, the transformation temperature for self-expanding nitinol peripheral stents allows for easy crimping at or below room temperature and reformation at body temperature becoming superelastic. CASE REPORT: We report the case of an elderly man with iliac stenting 1 month prior, who presented several weeks after recovering from coronavirus disease 2019 with recurrent anterior-wall ST-elevation myocardial infarction. This was complicated by deformation and infolding of the previously implanted nitinol self-expanding stent in his right common iliac artery (CIA). Understanding nitinol's specific properties, we proceeded with rapid injections of iced saline to cool the nitinol stent to its transformation temperature while nudging the distal end of the stent with a partially inflated balloon. This maneuver softened the nitinol stent, allowing us to "unfold" and reappose it against the wall of the right CIA, resulting in successful restoration of the original shape of the nitinol self-expanding stent. CONCLUSION: This represents the first reported case describing treatment of an infolded nitinol self-expanding peripheral stent by exploiting the transformation temperature of nitinol using iced cold saline to successfully restore the stent's original shape and structure.

Contemporary post-marketing adverse events and modes of failure related to VASCADE Vascular Closure System: The utility of the MAUDE database.

OBJECTIVES: To analyze post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for the VASCADE Vascular Closure System (Cardiva Medical Inc., Santa Clara, CA). BACKGROUND: The VASCADE Vascular Closure System is a closure device for femoral arterial and venous access-site closure that was approved by the FDA in 2013. However, post-marketing data and experience on the most commonly reported complications and modes of failure associated with the VASCADE Vascular Closure System are limited. METHODS: Post-marketing surveillance data from the FDA MAUDE database from October 2013 through March 2020 were analyzed, yielding 201 reports. RESULTS: Of the 201 reports of major complications involving VASCADE devices, 156 reports involved either injury (145) or death (11) related to the device. Of the 145 injury reports, bleeding was the most common adverse outcome described (85), followed by pseudoaneurysm (29) and pulselessness of an extremity (21). The device malfunction incidents (41 reports) were reported in three main categories, with deployment failure being the most commonly reported complication. CONCLUSIONS: Our analysis of the MAUDE database demonstrates that in contemporary post-marketing practice, physicians should be well-trained and educated to use the VASCADE closure device because improper utilization is a common cause of device failure, and complications with the VASCADE device can have profound clinical implications.

High-Risk Percutaneous Coronary Intervention of Native Coronary Arteries Without Mechanical Circulatory Support in Acute Coronary Syndrome Without Cardiogenic Shock.

Widespread utilization of mechanical circulatory support (MCS) for high-risk percutaneous coronary intervention (PCI) remains controversial, with a lack of randomized supporting evidence and associated risk of device-related complications. We investigated whether high-risk PCI of native coronary arteries without elective MCS in patients with acute coronary syndrome (ACS) is safe and feasible. We performed a single-center, retrospective analysis for ACS patients meeting American College of Cardiology high-risk criteria: unprotected left main disease, last remaining conduit, ejection fraction <35%, 3-vessel coronary artery disease, severe aortic stenosis, or severe mitral regurgitation. Patients with cardiogenic shock and those undergoing PCI of the bypass grafts were excluded. Major in-hospital and 30-day cardiovascular outcomes were assessed. From 2003 through 2018, 499 patients (847 lesions) with unstable angina pectoris (UAP), 1218 patients (1807 lesions) with non-ST-elevation myocardial infarction (NSTEMI), and 868 patients (1260 lesions) with ST-segment elevation myocardial infarction (STEMI) underwent high-risk PCI. Procedural success was achieved in 97.2% of UAP, 98.3% of NSTEMI, and 96.6% of STEMI patients. In-hospital and 30-day all-cause mortality were as follows: UAP, 2%; NSTEMI, 2.1%; and STEMI 4.7%. Bailout intra-aortic balloon pump was required in 1.6% of UAP, 3.1% of NSTEMI, and 10.3% of STEMI patients. Major complications for UAP, NSTEMI, and STEMI were, respectively: target lesion revascularization (2.3%, 1.4%, and 1.5%), stroke or transient ischemic attack (0.8%, 0.6%, and 1.3%), acute renal failure (8.2%, 7.2%, and 10.2%), major bleeding (1.6%, 3.1%, and 8.5%). In conclusion, our results show that high-risk PCI without elective MCS is safe and feasible in most ACS patients, challenging professional societies' current recommendations. A randomized trial comparing unprotected versus protected high-risk PCI for non-shock ACS patients is warranted.

Unprotected Left Main Percutaneous Coronary Intervention With or Without Hemodynamic Support.

Hemodynamic support is widely utilized for unprotected left main (ULM) percutaneous coronary interventions (PCI) despite lack of evidence from randomized studies and the risk of device-related complications. We aimed to compare ULMPCI with and without intra-aortic balloon pump (IABP) support. A single-center, retrospective analysis was performed for patients undergoing ULMPCI with and without IABP support. Clinical, procedural, in-hospital, and 30-day cardiovascular outcomes were compared. From 2003 through 2018, 217 patients underwent non-emergent ULMPCI, 55 with elective IABP support (IABP group), and 162 without support (No-IABP group). The study population comprised 56.4% men and 74.5% Caucasians in the IABP group and 53.7% men and 62.3% Caucasians in the No-IABP group. The mean age for IABP and No-IABP group patients was 75.75 ± 12.34 years and 73.47 ± 15.19 years, respectively (p = 0.315). Procedural success was achieved in 99% of IABP and 95.3% of No-IABP patients (p = 0.089). In-hospital and 30-day mortality was 5.5% for the IABP group and 5.6% for the No-IABP group (p = 0.977). Rates of major complications were statistically similar between the groups. Bailout IABP was required in 10% of No-IABP patients. Hospital and intensive care unit length of stay was statistically longer in the IABP group. In conclusion, ULMPCI without IABP support was not associated with increased mortality and major cardiovascular outcomes compared with supported patients and was associated with shorter hospital and intensive care unit stay. A randomized trial comparing unsupported versus supported ULMPCI is warranted to identify patients who would benefit from hemodynamic support.

Feasibility and Safety of High-Risk Percutaneous Coronary Intervention Without Mechanical Circulatory Support.

[Figure: see text].

Pre-Operative Cardiovascular Testing before Liver Transplantation.

End-stage liver disease (ESLD) is increasingly prevalent and shares many risk factors with coronary artery disease (CAD). No specific guidelines exist for pre-liver transplant evaluation of CAD, and pretransplant cardiovascular testing varies widely. The aim of this study is to characterize pre-transplant cardiac testing practices with post-transplant clinical outcomes. We retrospectively reviewed patients undergoing initial liver transplantation at our transplant center between January 2015 and March 2019. Patients with previous liver transplantation or multi-organ transplantation were excluded. Electronic medical records were reviewed for relevant demographic and clinical data. We included 285 patients with a mean follow-up of 2.4 years. Of 274 patients (96.1%) with pre-transplant transthoracic echocardiogram (TTE), 18 (6.6%) were abnormal. Non-invasive ischemic testing was performed in 193 (68%) patients: 165 (58%) underwent stress TTE, 24 (8%) underwent myocardial perfusion imaging, 3 underwent coronary computed tomography, and 1 underwent exercise electrocardiogram. Sixteen patients (6%) had left heart catheterization of which 10 (63%) were abnormal and 5 proceeded to revascularization before transplant. There were 4 (1.4%) deaths within 30 days of transplant and 23 deaths (8.1%) in total. ST-elevation myocardial infarction was seen in 1 patient within 30 days and 1 patient after 30 days (0.7% total). No cardiovascular deaths were observed. Among patients undergoing liver transplantation, pre-transplantation cardiovascular testing is exceedingly common and post-transplant cardiovascular complications are rare. Additional research is needed to determine the optimal testing and surveillance in this patient population.

A Patient-Level, Pooled Analysis of Mortality Rates With the Passeo-18 Lux Paclitaxel Drug-Coated Balloon in Peripheral Arterial Disease.

BACKGROUND: Recent meta-analyses have raised concerns about mortality with paclitaxel drug-coated balloons (DCB). This pooled, patient-level analysis of the BIOLUX P-I, P-II, and P-III studies was performed to evaluate the safety and efficacy of Passeo-18 Lux DCB. MATERIALS AND METHODS: Individual patient-level demographic, clinical, diagnostic, and procedural data from the BIOLUX P-I, BIOLUX P-II, and BIOLUX P-III studies were pooled in a common database. Clinical safety (all-cause mortality and cardiovascular mortality) and efficacy (any amputation, target lesion/vessel revascularization) were extracted. Cox proportional modeling was used to assess the effect of critical limb ischemia at the time of enrollment and the occurrence of new amputation as a time-dependent variable on mortality. RESULTS: A total of 1009 patients were included in the analysis. Sixty-six patients were treated with percutaneous transluminal angioplasty (PTA) and 943 underwent DCB angioplasty. The cumulative incidence of all-cause mortality did not differ between the groups (PTA 6.7%, DCB 6.7%, p = 0.65). The composite efficacy endpoint of freedom from any amputation and target lesion/vessel revascularization was superior in the DCB arm compared to PTA [PTA 28.8%, DCB 16.7%, p = 0.02]. Both in unadjusted and adjusted Cox proportional models (adjusted for critical limb ischemia and amputation), the use of DCB was not associated with any mortality at 1 year. CONCLUSIONS: Our patient-level analysis shows that overall, the use of the Passeo-18 Lux paclitaxel DCB in infrainguinal arteries was not associated with increased mortality at 1 year and reinforces the efficacy of DCB angioplasty in preventing amputation or the need for reintervention.

Cangrelor vs. glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention.

BACKGROUND: To date, there are no real-world studies comparing cangrelor to glycoprotein IIb/IIIa inhibitors (GPI) during percutaneous coronary intervention (PCI). Thus, we performed this study to evaluate the safety and effectiveness of cangrelor compared to GPI during PCI. METHODS: We identified patients who underwent PCI at our institution who received either cangrelor or GPI during PCI. Patients already on GPI or cangrelor prior to PCI or who received both cangrelor and GPI were excluded. Baseline demographics and clinical outcomes were extracted. Major bleeding is defined as a composite of major hematoma >4 cm, hematocrit drop >15, and gastrointestinal bleeding. RESULTS: A total of 2072 patients received adjunctive antiplatelet therapy during PCI (cangrelor [n=478]; GPI [n=1594]). Patients' mean age was 61±12 years. Most (66%) presented with acute coronary syndrome. Patients who received cangrelor were older and had a higher percentage of acute coronary syndrome and lower baseline hematocrit in comparison with patients who received GPI. Procedural success was achieved in 94% of patients, with no difference between groups. Major bleeding events (1.7% vs. 5.1%, P=.001), any vascular complication rates, and hospital length of stay were significantly lower in the cangrelor group. In-hospital ischemic events did not differ between groups. On regression analysis, patients on cangrelor were noted to have significantly lower major bleeding events (OR 0.23; 95% CI, 0.09-0.59). CONCLUSIONS: Balancing ischemic and bleeding risks with adjunctive antiplatelet drugs is of prime importance during PCI. Our real-world analysis shows that cangrelor is safe and effective when compared to GPI during PCI.

Propensity-matched comparison of large-bore access closure in transcatheter aortic valve replacement using MANTA versus Perclose: A real-world experience.

OBJECTIVE: Compare two large-bore vascular closure devices (VCDs), collagen-plug-based MANTA and suture-based dual Perclose ProGlide (PP), in patients undergoing contemporary transfemoral transcatheter aortic valve replacement (TAVR). BACKGROUND: The SAFE MANTA IDE clinical trial demonstrated that the collagen-plug-based MANTA VCDs were safe and effective in closing large-bore arteriotomies. However, data comparing this collagen-plug-based VCD to the suture-based VCD in contemporary practice are sparse. METHODS: This was a retrospective observational study in which we screened transfemoral (TF) TAVR patients at our institution from 2017 to 2020. Included were those whose large-bore TF access was closed using either MANTA or PP with and without Angio-Seal. Our primary outcome was VCD success. Additional in-hospital outcomes included major and minor vascular complications, post-TAVR length of stay, and mortality. RESULTS: We screened 696 patients who underwent TAVR. Using propensity scores, we matched 124 patients who received MANTA with 124 patients who received PP. Patients had a mean age of 77.2 years, 69.0% were men, and their mean Society of Thoracic Surgeons score was 3.4%. VCD success was equivalent between VCDs (95.2% vs. 95.2%; p = 1.000). Patients had similar rates of mortality (0% vs. 0.8%; p = .316), and no patients had major vascular complications. CONCLUSIONS: In contemporary TAVR, the collagen-plug-based MANTA VCD appears to be as safe and effective as the suture-based dual PP VCD, with no differences in VCD success, vascular complications, or mortality. Therefore, selection of VCD for TAVR should be left to operator discretion, taking into account anatomical considerations.

One-Year Outcomes After Treatment of Ostial In-Stent Restenosis in Left Circumflex Versus Left Anterior Descending or Right Coronary Artery.

The prognosis of left circumflex (LC) versus non-LC in-stent restenosis (ISR) ostial lesions following treatment has not been assessed. We aimed to assess this prognosis. Anecdotally, treatment of ostial LC ISR has been associated with high recurrence rates. We performed a retrospective analysis of patients from our institution who underwent coronary intervention of an ostial ISR lesion between 2003 and 2018. The primary endpoint was target lesion revascularization (TLR) and major adverse cardiovascular events (MACE). Overall, 563 patients underwent ostial ISR lesion intervention, 144 for an ostial LC ISR lesion. Compared to patients with ostial ISR in non-LC lesions, patients with ostial LC ISR were older, had higher rates of diabetes mellitus and previous coronary bypass surgery. At 1-year follow-up, TLR-MACE rates were 26.6% in the LC group versus 18.4% in the non-LC group (p = 0.036). The TLR rate was also higher in the LC group compared to the non-LC group (p = 0.0498). Univariate and multivariate analyses demonstrated a higher TLR-MACE rate for LC versus non-LC ostial ISR lesions. In conclusion, our study shows increased event rates after treatment of LC versus non-LC ISR lesions. Further studies should be done to assess the optimal treatment approach for ostial LC ISR.

Real-world experience of suture-based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience.

OBJECTIVES: We analyzed post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture-based vascular closure devices (VCDs) - Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott). BACKGROUND: Suture-based VCDs are mostly used for large-bore femoral arterial access-site closure. Real-world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited. METHODS: Post-marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports. RESULTS: Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture-related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group. CONCLUSIONS: Our analysis of the MAUDE database demonstrates that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre-procedural patient selection are important to minimize risks associated with suture-based vascular closure devices.

Treatment of a Heavily Calcified Celiac Artery Ostial Subtotal Occlusion Using Shockwave Lithotripsy: A Novel Approach.

PURPOSE: We present the novel use of adjunctive intravascular lithotripsy (IVL) before definitive intravascular stenting of a heavily calcified celiac artery ostial occlusion. CASE REPORT: A 79-year-old woman presented with chronic post-prandial abdominal pain and weight loss. Selective angiography revealed a sub-totally occluded celiac artery. Percutaneous endovascular intervention of the celiac artery was attempted but was unsuccessful because of heavy calcification. The patient returned for a repeat procedure. A guidewire was successfully advanced across the sub-totally occluded ostium. A Shockwave Lithotripsy BDC 7.0-mm/60-mm balloon catheter (Shockwave Medical Inc., Santa Clara, California) was successfully used to modify the calcified plaque. Next, a stent was deployed for definitive therapy. The final angiogram showed an excellent result. The patient tolerated the procedure well and was sent home on dual antiplatelet therapy. Nine months after the procedure, she had gained weight and denied any further post-prandial abdominal pain. CONCLUSION: IVL treatment modality to modify calcified lesions in the splanchnic circulation should be considered as a novel approach to patients in whom traditional endovascular treatment modalities are thought to be suboptimal. Further controlled studies are needed to access the safety, feasibility, and efficacy of the use of this novel technology in this vascular territory.