Key Points

• Many patients with severe mitral valve regurgitation are not candidates for surgical valve replacement or transcatheter edge to edge repair due to anatomical limitations.
• Transcatheter mitral valve replacement is currently under investigation with mostly transapical devices, which could be of added risk to patients.
• In an early feasibility study of 15 patients, the APOLLO transcatheter mitral valve, a trans-septal based transcatheter valve replacement, was shown to significantly decrease mitral regurgitation in all patients.
• At 30 day follow up there were no patient deaths. Major vascular access complications were seen in 40% of patients, which is an area that investigators hope to improve upon in the near future.

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Key Points

• Transcatheter Tricuspid Valve Replacement with the EVOQUE valve is being studied in the TRISCEND study
• Patients with symptomatic, moderate to severe tricuspid regurgitation were evaluated for the TRISCEND study, a single-arm prospective multicenter study.
• At six months, there was sustained significant reduction in tricuspid regurgitation.
• Procedural complications were low, and mostly driven by severe bleeding.

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Key Points:

• Patients undergoing PCI for in-stent restenosis (ISR) were treated with either SeQuent paclitaxel-coated balloons (the current standard of care) or SeQuent sirolimus-coated balloons. Only patients with stable angina, unstable angina, or a positive functional study were included (ie, not acute STEMI patients). Two parallel multicenter trials were performed and pooled for this analysis.
• The primary outcome was late luminal loss at 6 months. Important secondary outcomes included target lesion revascularization, stent thrombosis, all-cause death, and MI.
• Treatment with sirolimus-coated balloons was noninferior to paclitaxel-coated balloons in the primary endpoint, and there were no significant differences in the secondary outcomes. Further evidence with long-term outcomes and larger studies for clinical endpoints will be required.

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Key Points:

• In this follow-up study to GUIDE-HF, HF patients with hemodynamic-guided therapy using a CardioMEMS device were compared to those with standard care. The primary outcome was a composite of all-cause mortality and HF events (including HF hospitalizations and urgent HF visits) at one year. In this sub-study, only patients in the pre-COVID era were examined. All results were stratified by ejection fraction (HFrEF vs HFpEF) and NYHA class (II/III vs II-IV).
• Treatment with hemodynamic-guided therapy resulted in a reduction in the primary outcome, but only in the HFpEF group in NYHA II-III populations; this was not seen in HFrEF or in NYHA II-IV populations. HF events were reduced in both HFrEF and HFpEF populations in the treatment arm, but once again only in the NYHA II-III (and not II-IV) population. The mean PA pressure was reduced in the treatment arm only in the HFrEF population.

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Key Points:

• In the OPT-PEACE trial, patients undergoing complete revascularization with current generation stents received 6 months of DAPT with aspirin and clopidogrel and were subsequently randomized to either a) ongoing DAPT, b) aspirin alone, or c) clopidogrel alone for the remaining 6 months.
• The primary outcome was gastrointestinal mucosal injury (erosion, ulceration or bleeding) at 6 or 12 months. Important secondary outcomes included clinically relevant bleeding and ischemic events. GI mucosal injury was evaluated via a novel non-invasive capsule monitoring system (AMCE).
• Treatment with SAPT resulted in lower GI mucosal injury as well as clinically relevant bleeding at 6 or 12 months. No ischemic events were observed by 12 months.

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Key Points

• • To determine success of percutaneous left atrial appendage occlusion (LAAO), residual patency of the appendage is assessed at 45 days, either via transesophageal echocardiogram or cardiac CT-A.
  • AMULET IDE showed that the Amulet device was noninferior to the Watchman device in preventing residual leak. This trial, however, did not assess the newer generation Watchman FLX device, one of the main counterarguments to the results.
  • Participants in this study were randomized to receive either the Amulet device or Watchman FLX for left atrial appendage occlusion. Device leak and appendage patency was assessed at 45 days by Cardiac CT-A.
  • At 45 days, the Amulet device was no different to Watchman when comparing patent appendages, but did have fewer rates of intra-device leak and mixed leak when assessed by TEE. Procedure-related complications, including death, CVA, major bleeding, and pericardial effusion were all higher in the Amulet arm when compared to the Watchman arm.

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Key Points

• The AMULET Left Atrial Appendage Occluder was shown to be noninferior to the Watchman device for patients with atrial fibrillation; results of the AMULET-IDE trial were presented at the European Society of Cardiology In August, 2021.
• Primary AMULET IDE results showed not only safety at 12 months and effectiveness at 18 months, but closure at 45 days, defined as peridevice leak of <5 mm.
• 12 month follow up with core-lab echocardiographic analysis of perivalvular leak, fewer patients with the AMULET device had moderate peridevice leak when compared to the Watchman device. Long term implications and consequences of peridevice leak are yet unknown.

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Key Points

• The SURTAVI trial randomized patients at intermediate risk for aortic valve replacement to receive either TAVR with and without PCI using a supra-annular self-expanding valve, to surgical AVR with and without CABG.
• This is the first reporting of the five-year follow up data for the original trial, assessing both clinical outcomes and echocardiographic measurements.
• At five years, there was no difference in all-cause mortality, disabling stroke, valve endocarditis, or valve thrombosis.

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Despite advances in therapy, the choice and duration of antiplatelet therapy following percutaneous coronary intervention (PCI) remains an area of active debate. While it has been postulated that long-term dual antiplatelet therapy (DAPT) are associated with reduced rates of thrombotic events, these benefits have been  offset by increased bleeding risk.

In the initial STOPDAPT-2 trial, which included patients with stable coronary artery disease (CAD) and with acute coronary syndrome (ACS) undergoing PCI, a strategy of 1 month of dual antiplatelet therapy (DAPT) followed by clopidogrel monotherapy was associated with significant reduction in the composite of cardiovascular and bleeding events when compared to standard-of-care 12 months of DAPT. While the net clinical benefit was observed in the overall population, the trial was not sufficiently powered to compare the effect of the 2 treatment strategies among ACS patients alone.

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Key Points:

• In the PRAGUE-17 study, patients with non-valvular atrial fibrillation were treated with either oral anticoagulants or left atrial appendage closure devices and followed over a median of 3.5 years of follow-up. The primary endpoint was a composite of stroke or TIA, systemic embolism, clinically relevant bleeding, CV death, or peri-procedural/device complication.
• Treatment with left atrial appendage closure was noninferior to NOAC treatment at long-term follow-up and was associated with significantly less non-procedural bleeding. Continue reading →

In patients with severe aortic stenosis (AS) undergoing transfemoral transcatheter aortic valve implantation (TAVI), periprocedural vascular complications are common and contribute significantly to the overall morbidity and mortality. These vascular complications are commonly related to the arterial access site of the TAVI procedure. As numerous plug-based and suture-based percutaneous vascular closure devices (VCDs) have been approved and available in the market, the real-world approach to vascular closure has been variable as these devices have been used interchangeably. Nonetheless, despite the abundance of these device closure techniques, randomized trials to compare techniques are lacking and remain an unmet need.

The CHOICE-CLOSURE trial (Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation) was an investigator-initiated, single-center, prospective, open-label randomized controlled trial that compared interventional access site closure using a plug-based strategy vs. suture-based strategy for during transfemoral TAVI. In the study, the investigators hypothesized that a relevant difference in the rate of peri-procedural complications of effectiveness of vascular closure would be present with either strategy vs. the other. Major exclusion criteria included, but were not limited to, vascular access site anatomy non-suitable for percutaneous vascular closure, prior history of vascular site complications, absence of computer tomographic data of the access site prior to the procedure, and known bleeding diathesis or significant unmanageable anemia.

Between June 2020 and July 2021, a total of 516 patients with severe AS undergoing transfemoral TAVI were randomly assigned in a 1 to 1 manner to have vascular access site closure using either a plug-based technique (MANTA, Teleflex Wayne PA) (n=258 patients) or a primary suture-based technique (ProGlide, Abbott Vascular, Abbott Park, IL) (n=258 patients). The primary outcome of the trial was the rate of in-hospital access-site or access-related vascular injury according to the Valve Academic Research Consortium-2 (VARC-2) definition through 7 days. Secondary outcomes included the rate of access-site or access-related vascular injury, as well as rate of VCD failure, and time to hemostasis.

The primary outcome occurred in 19.4% (50/258) of patients randomized to the plug-based technique, as compared with only 12.0% (31/258) in patients in the primary suture-based technique group (RR 1.61, 95% CI [1.07-2.44], p=0.029). There were no statistically significant differences in access-site or access related bleeding (11.6% vs. 7.4%, p=0.133) or device failure (4.7% vs. 5.4%, p=0.841). Time to hemostasis was significantly shorter with the plug-based technique (80 seconds vs. 240 seconds, p<0.001). Overall, the trial concluded that a pure plug-based vascular closure technique was associated with higher rates of access-site or access-related vascular complications, but shorter time to hemostasis, as compared with primary suture-based technique.

The results of the CHOICE-CLOSURE trial were presented by the principal investigator, Prof. Mohamed Abdel-Wahab, MD PhD (Leipzig Heart Center/University of Leipzig, Germany) on November 5^th, 2021 at 11:40 AM EDT as a late-breaking clinical trial at TCT 2021 in Orlando, FL and published simultaneously in Circulation.  The study was funded by Helios Kliniken GmbH; and Prof. Abdel-Wahab reported consulting fees/honoraria from Boston Scientific and Medtronic.

Key Points:

• In this pre-specified MASTER DAPT sub-study, patients with high bleeding risk and high ischemic risk (the latter of which was defined as those who have had a myocardial infarction within the last 12 months) who were treated with PCI with an Ultimaster stent were randomized to either standard care dual antiplatelet therapy (DAPT) or abbreviated DAPT starting after 30 days of DAPT post PCI. Standard DAPT was defined as an additional 2 or 5 month duration (with or without anticoagulation, respectively) followed by single antiplatelet therapy (SAPT) for up to 11 months following randomization. Abbreviated DAPT was defined as immediate DAPT discontinuation followed by SAPT for 11 months (or 5 months with anticoagulation).
• The three co-primary endpoints included the following at one year: a) net adverse clinical events (NACE), b) major adverse cardiac and cerebral events (MACCE), and c) major or clinically relevant non-major bleeding (MCB).
• Treatment with abbreviated DAPT was not significantly different from standard DAPT for NACE and MACCE in patients with high ischemic risk. Abbreviated DAPT resulted in lower major or nonmajor bleeding. There were no significant differences between the patients with high ischemic risk and those without.

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Key Points:

• • Patients with diabetes who undergo PCI are more likely to have target lesion failure and target vessel revascularization than their non-diabetic counterparts.
  • The Cre8 EVO stent is polymer-free with thin stent struts and elutes sirolimus via an amphiphilic carrier to promote drug delivery.
  • After diabetic participants were randomized in a 1:1 fashion the Cre8 EVO not only met noninferiority for target lesion failure, but suggested superiority for the same endpoint when compared to the Resolute Onyx stent.

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Key Points:

• Quantitative Flow Reserve (QFR) is a non-pressure wire method of assessing flow through the coronary arteries, using 3D reconstructions and computations from the angiogram.
• 3825 patients across several centers in China were randomized to receive PCI by standard angiography versus QFR guidance, in which stents were placed for vessels with QFR <0.8.
• At one year, MACCE was significantly lower in the QFR group compared to the standard angiography group (5.8 vs. 8.8%).
• Study authors suggest the use of QFR will increase over pressure-wire guided physiology due to its ease of use.

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The use of fractional flow reserve in the assessment of ischemia has increased over the past decade, as it has made its way into the guidelines for coronary revascularization. Some argue that it is still underutilized, and blame several factors for this: the need for a wire, which could introduce procedural complications; the added cost of the FFR wire and system; as well as added procedural time and the need for heparin. In a late breaking session at the 33^rd annual TCT conference, Dr. Bo Xu (Beijing, China) presented the findings of FAVOR III, a trial in which a novel physiologic assessment tool was used to guide PCI strategy in patients presenting to the cardiac catheterization lab.

Quantitative Flow Reserve (QFR) is an angiography-based physiologic measurement of coronary flow. Using high quality angiograms from two orthogonal views of each vessel, a three-dimensional reconstruction of the vessel is created. After inputting TIMI flow, a flow reserve measurement is calculated using the principles of fluid dynamics. Hyperemia and anticoagulation are not required for accurate measurements.

Investigators of FAVOR III China sought to answer whether standard use of QFR to guide PCI conferred any benefit over angiography alone, as did the current gold standard, FFR. In this multi-center sham-controlled, blinded randomized trial, participants undergoing coronary angiography for stable angina, unstable angina, and myocardial infarction were randomized to receive either QFR-guided PCI or standard angiography-guided PCI. After coronary angiography demonstrated at least one epicardial vessel of 2.5 mm reference diameter with 50-90% stenosis, participants were randomized in a 1:1 fashion. In the QFR arm, any qualifying lesion was assessed with QFR. If the QFR was >0.80, PCI was deferred, and if ≤0.80, PCI was performed. Participants and clinical assessors were blinded in the following fashion: participants were given headphones with music to wear during the length of the procedure; a 10 minute delay for QFR and sham calculation was implemented in both arms before the PCI; QFR results were not allowed into the medical record; and personnel involved in the PCI were precluded from participation in follow up.

At one year, 1905 participants in the QFR group and 1897 in the standard group were available for follow up. Participants were mostly men with a mean age of 63 years. Smoking, hyperlipidemia, and diabetes were present in a third of either arm, while hypertension was present in two thirds. 58% of either group underwent the procedure for unstable angina, and 25.8% of each group underwent angiography for stable angina. Multi-vessel disease was present in more than half of participants.

QFR Guidance Changed Strategy
The use of QFR did have an impact on whether PCI was undertaken. Of the vessels that were intended to be treated, 19.6% were deferred based on negative QFR values, compared to only 5.2% in the angiography group. 4.4% of vessels not initially intended to be treated were treated after receiving positive QFR values.

Results

At one year, MACE event rates were lower in the QFR-guided group compared to the angiography-guided group at 5.8% vs. 8.8% (HR 0.65 [95% CI 0.51 – 0.83], p = 0.004). The secondary outcome of MACE excluding peri-procedural MI

followed suit, with a decrease in event rates from 4.8% to 3.1 % (HR 0.64 [95% CI 0.46 – 0.89], p = 0.0073). There was no significant difference in the two groups when it came to other secondary endpoints, including periprocedural MI, target vessel revascularization and stent thrombosis.

In an interview with Dr. C. Michael Gibson, Dr. Bo Xu commented on the results, stating that he hopes to see a shift toward the use of QFR-guided PCI, as the technology is widely available in cardiac catheterization laboratories across China. “The benefit of a quick, 3 minute analysis, without the need for a wire or added procedural complications makes this strategy the most favorable method of hemodynamic assessment,” he stated before adding “It also ensures that patients are getting PCI for the right reasons”.  Some limitations of the study were its enrollment of lower risk patients as well as the lower rates of coronary imaging during PCI.  The study was simultaneously printed in Lancet.

Key Points:

• • All-comers with three vessel disease were randomized to undergo FFR-guided PCI or Coronary Artery Bypass Grafting in this multicenter, international randomized control trial.
  • FFR-guided PCI failed to meet noninferiority for the primary endpoint of MACCE (death, MI, stroke or repeat revascularization) at 1 year. There was no difference in the secondary endpoints, including those of procedural MI and stroke.
  • A subgroup analysis of patients with very low SYNTAX scores showed this to be the only group in which PCI is non-inferior to CABG.

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