Real-World Outcomes for the Fifth-Generation Balloon Expandable Transcatheter Heart Valve in the United States.

BACKGROUND: The fifth-generation SAPIEN 3 Ultra Resilia valve (S3UR) incorporates several design changes as compared with its predecessors, the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) valves, including bovine leaflets treated with a novel process intended to reduce structural valve deterioration via calcification, as well as a taller external skirt on the 29-mm valve size to reduce paravalvular leak (PVL). The clinical performance of S3UR compared with S3 and S3U in a large patient population has not been previously reported. OBJECTIVES: The aim of this study was to compare S3UR to S3/S3U for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR). METHODS: Patients enrolled in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between January 1, 2021, and June 30, 2023, who underwent TAVR with S3UR or S3U/S3 valve platforms were propensity-matched and evaluated for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes. RESULTS: 10,314 S3UR patients were propensity matched with 10,314 patients among 150,539 S3U/S3 patients. At 30 days, there were no statistically significant differences in death, stroke, or bleeding, but a numerically higher hospital readmission rate in the S3UR cohort (8.5% vs 7.7%; P = 0.04). At discharge, S3UR patients exhibited significantly lower mean gradients (9.2 ± 4.6 mm Hg vs 12.0 ± 5.7 mm Hg; P < 0.0001) and larger aortic valve area (2.1 ± 0.7 cm2 vs 1.9 ± 0.6 cm2; P < 0.0001) than patients treated with S3/S3U. The 29-mm valve size exhibited significant reduction in mild PVL (5.3% vs 9.4%; P < 0.0001). CONCLUSIONS: S3UR TAVR is associated with lower mean gradients and lower rates of PVL than earlier generations of balloon expandable transcatheter heart valve platforms.

A Novel Earbud Detects Aortic Stenosis Murmur Before and After Transcatheter Aortic Valve Replacement.

Noninvasive infrasonic hemodynography using the MindMics earbuds captures low-frequency acoustic vibrations throughout the cardiac cycle. In an n-of-1 analysis, we propose a new method of assessing severe aortic stenosis by using infrasonic hemodynography to detect its characteristic systolic ejection murmur before and after transcatheter aortic valve replacement.

Transcatheter aortic valve replacement: a palliative approach to infective endocarditis.

An 88-year-old man with small lymphocytic lymphoma presented to the hospital with shortness of breath and was diagnosed with heart failure. Serial blood cultures and echocardiography revealed Staphylococcus epidermidis endocarditis, complicated by severe aortic regurgitation. Despite intravenous antibiotic therapy and aggressive intravenous diuresis therapy in the hospital, he decompensated into cardiogenic shock, requiring invasive haemodynamic monitoring and inotrope therapy. With multidisciplinary discussion involving the patient and his children, there was a joint decision that at his advanced age, he would not pursue surgical aortic valve replacement and instead proceed with a transcatheter aortic valve replacement (TAVR) with palliative intent. He underwent TAVR with subsequent symptomatic and functional improvement as well as resolution of cardiogenic shock.

Transcatheter treatment of complex pulmonic and aortic valvular disease following failed Ross procedure.

A 63-year-old man with congenital bicuspid aortic valve disease and complex surgical history (that includes a Ross procedure complicated by cardiac arrest requiring emergency coronary artery bypass graft surgery, multiple subsequent sternotomies to treat a failed pulmonic homograft and pseudoaneurysm repair of the left and right ventricular outflow tracts (LVOT/RVOT), bioprosthetic aortic valve replacement, and aortic valve endocarditis) presented with worsening heart failure symptoms secondary to bioprosthetic aortic valve failure and recurrent pulmonic valve stenosis successfully treated with transcatheter intervention.

Imaging Evaluation and Interpretation for Vascular Access for Transcatheter Aortic Valve Replacement.

Transcatheter aortic valve replacement (TAVR) has emerged as an effective therapy for aortic stenosis in patients who are at intermediate and high surgical risk. Vascular access remains critical to the success of the TAVR procedure. This article reviews the use of imaging in planning and executing TAVR access.

Clinical outcomes of endovascular treatment of TASC-II C and D femoropopliteal lesions with the Viabahn endoprosthesis.

OBJECTIVES: The objective of this study was to evaluate clinical outcomes and patency rates using the Viabahn endoprosthesis in complex (TASC-II C and D) femoropopliteal lesions. BACKGROUND: Traditional treatment of symptomatic TASC-II C and D femoropopliteal lesions has mainly centered on open surgical options in patients deemed appropriate candidates. Endovascular treatment of these lesions with balloon angioplasty has been historically hampered by aggressive restenosis and relatively early clinical failure. The Viabahn endoprosthesis was developed with the intent of reducing restenosis while improving overall flexibility in the femoropopliteal segment. METHODS: Between March 2009 and July 2011 a total of 51 limbs in 41 patients underwent implantation of one or more Viabahn endovascular stent grafts for the treatment of symptomatic TASC-II C or D lesions. Patients were followed clinically at regular intervals and also underwent routine surveillance duplex ultrasound at 1, 3, 6, and 12 months post-procedure. The average follow-up from the index procedure was 14.6 months (range 13-35.2 months). RESULTS: A total of 22 TASC-II C and 29 TASC-II D lesions were treated (51 limbs in 41 patients). The mean lesion length was 22.4 cm. The overall 1-year primary patency rate was 74.8% (95% CI: 61.2%-88.4%), assisted primary patency rate was 87.4% (95% CI: 70.9%-95.9%), and the secondary patency rate was 94.9% (95% CI: 88.0%-100.0%). CONCLUSIONS: The Viabahn endoprosthesis is a safe and effective option for the treatment of TASC-II C and D femoropopliteal lesions. Patency rates are favorable despite the complexity of these lesions, although multiple endovascular re-interventions may be necessary to achieve an acceptable long-term result.

Use of intravascular ultrasound to guide endovascular repair of popliteal artery aneurysms.

OBJECTIVES: To evaluate the outcomes of intravascular ultrasound (IVUS) directed endovascular exclusion of popliteal artery aneurysm (PAA) using stent grafts. METHODS: Clinical data of seven patients who underwent endovascular exclusion of PAA using IVUS guidance between 2009 and 2011 were retrospectively analyzed. Outcome measures included graft patency, endoleak, and clinical symptoms. RESULTS: A total of seven patients were treated with Viabahn stent grafts using IVUS guidance. No patients were lost to follow-up (mean 12 ± 2 months). Patients had an average of two vessel runoff at the end of the procedure. All patients were symptom free with patent stents and no evidence of endoleak at follow-up. CONCLUSIONS: Use of IVUS during endovascular treatment of PAA allows the physician to fully appreciate the anatomy of PAA, including location and extent of thrombus burden and the diameter and location of desired landing zones for appropriate sealing of the aneurysm proximally and distally. IVUS-guided treatment is associated with excellent outcomes and does not increase procedural radiation and contrast load.

Zotarolimus-eluting peripheral stents for the treatment of erectile dysfunction in subjects with suboptimal response to phosphodiesterase-5 inhibitors.

OBJECTIVES: This study sought to evaluate the safety and feasibility of zotarolimus-eluting stent implantation in focal atherosclerotic lesions of the internal pudendal arteries among men with erectile dysfunction (ED) and a suboptimal response to phosphodiesterase-5 inhibitors. BACKGROUND: ED, a common condition, is often mediated by atherosclerosis. Current treatment options are limited. METHODS: Male subjects with atherosclerotic ED and a suboptimal response to phosphodiesterase-5 inhibitors were enrolled in this prospective, multicenter, single-armed safety and feasibility trial. A novel combination of clinical, duplex ultrasound, and invasive angiographic factors were used to determine eligibility for stent therapy. The primary safety endpoint was any major adverse event 30 days after the procedure. The primary feasibility end point was improvement in the International Index of Erectile Function (Erectile Dysfunction Domain) score ≥ 4 points in ≥ 50% of subjects at 3 months. We report 6-month follow-up results, including duplex ultrasound and angiography. RESULTS: Forty-five lesions were treated with stents in 30 subjects. Procedural success was 100% with no major adverse events through follow-up. The primary feasibility endpoint at 6 months was achieved by 59.3% of intention-to-treat subjects (95% confidence interval: 38.8% to 77.6%) and 69.6% of per-protocol subjects (95% confidence interval: 47.1% to 86.8%). Duplex ultrasound peak systolic velocity of the cavernosal arteries increased from baseline by 14.4 ± 10.7 cm/s at 30 days and 22.5 ± 23.7 cm/s at 6 months. Angiographic binary restenosis (≥ 50% lumen diameter stenosis) was reported in 11 (34.4%) of 32 lesions. CONCLUSIONS: Among patients with ED and limited response with pharmacologic therapy, percutaneous stent revascularization of the internal pudendal artery is feasible and is associated with clinically meaningful improvement in both subjective and objective measures of erectile function.

Standard- vs high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial.

CONTEXT: High platelet reactivity while receiving clopidogrel has been linked to cardiovascular events after percutaneous coronary intervention (PCI), but a treatment strategy for this issue is not well defined. OBJECTIVE: To evaluate the effect of high-dose compared with standard-dose clopidogrel in patients with high on-treatment platelet reactivity after PCI. DESIGN, SETTING, AND PATIENTS: Randomized, double-blind, active-control trial (Gauging Responsiveness with A VerifyNow assay-Impact on Thrombosis And Safety [GRAVITAS]) of 2214 patients with high on-treatment reactivity 12 to 24 hours after PCI with drug-eluting stents at 83 centers in North America between July 2008 and April 2010. INTERVENTIONS: High-dose clopidogrel (600-mg initial dose, 150 mg daily thereafter) or standard-dose clopidogrel (no additional loading dose, 75 mg daily) for 6 months. MAIN OUTCOME MEASURES: The primary end point was the 6-month incidence of death from cardiovascular causes, nonfatal myocardial infarction, or stent thrombosis. The key safety end point was severe or moderate bleeding according to the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) definition. A key pharmacodynamic end point was the rate of persistently high on-treatment reactivity at 30 days. RESULTS: At 6 months, the primary end point had occurred in 25 of 1109 patients (2.3%) receiving high-dose clopidogrel compared with 25 of 1105 patients (2.3%) receiving standard-dose clopidogrel (hazard ratio [HR], 1.01; 95% confidence interval [CI], 0.58-1.76; P = .97). Severe or moderate bleeding was not increased with the high-dose regimen (15 [1.4%] vs 25 [2.3%], HR, 0.59; 95% CI, 0.31-1.11; P = .10). Compared with standard-dose clopidogrel, high-dose clopidogrel provided a 22% (95% CI, 18%-26%) absolute reduction in the rate of high on-treatment reactivity at 30 days (62%; 95% CI, 59%-65% vs 40%; 95% CI, 37%-43%; P < .001). CONCLUSIONS: Among patients with high on-treatment reactivity after PCI with drug-eluting stents, the use of high-dose clopidogrel compared with standard-dose clopidogrel did not reduce the incidence of death from cardiovascular causes, nonfatal myocardial infarction, or stent thrombosis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00645918.

Clinical outcomes following predilation with a novel 1.25-mm diameter angioplasty catheter.

OBJECTIVE: An unmet need is represented in angioplasty catheters that permit the predilation stage of treating complex coronary anatomy oftentimes not amenable to conventional device therapies. BACKGROUND: Lesion preparation with balloon angioplasty prior to stent placement remains the most common method of percutaneous coronary revascularization. METHODS: Clinical and angiographic outcomes were evaluated following a treatment strategy of coronary artery disease that included predilation with a low-profile, 1.25-mm angioplasty catheter prior to stent placement. The study primary end point of procedural success was defined as successful device delivery and lesion treatment, including the absence of clinically significant perforation, arrhythmia, flow-limiting dissection, or reduction in baseline Thrombolysis In Myocardial Infarction (TIMI) grade with final achievement of TIMI 3 flow. RESULTS: Among 51 patients (54 lesions), predilation using a 1.25 mm angioplasty catheter was associated with procedural and device-related success rates of 100%. In-hospital target lesion failure occurred in one patient (2.0%) related to postprocedural myocardial infarction. Patient and angiographic characteristics included diabetes, 43.1%; lesion length ≥ 20 mm, 20.4%; bifurcation lesion, 31.5%; lesion classification B2/C, 74.1%; and baseline TIMI 0/1 flow, 13.0%. No subsequent in-hospital adverse events occurred. CONCLUSIONS: Percutaneous coronary revascularization involving a predilation strategy with a low profile, 1.25-mm angioplasty catheter is associated with favorable procedural safety and efficacy and may represent an effective initial treatment for complex coronary anatomy.

A novel technique for ultra-low contrast administration during angiography or intervention.

Contrast-induced nephropathy (CIN) after coronary angiography or intervention is associated with substantial morbidity. The data supporting various prophylactic measures and adjunctive therapies to prevent this complication are conflicting. However, contrast volume is clearly related to CIN after percutaneous coronary intervention (PCI), and the risk of CIN has been shown to be directly related to contrast dose. Therefore, minimizing contrast exposure is a primary method to reduce the risk of CIN, especially in at-risk patients. We report a novel technique designed to deliver ultra-low (<15 cm(3)) volume contrast to patients with chronic kidney disease undergoing coronary angiography and PCI.

Three-year outcome of drug-eluting stent implantation for coronary artery bifurcation lesions.

OBJECTIVES: To compare the very long-term clinical outcomes of bifurcation lesions using the crush and the simultaneous kissing stent (SKS) techniques. BACKGROUND: A variety of two-stent techniques have been used to treat coronary artery bifurcation lesions in the drug-eluting stent era, but the long-term clinical outcome of these approaches is not known. METHODS: A total of 74 consecutive patients underwent bifurcation stenting using either the crush or SKS techniques. Mean patient age was 66.91 + or - 11.3 years; 26% were diabetic, and the left anterior descending/diagonal bifurcation was the most frequently treated lesion (68%). RESULTS: In-hospital outcomes were not significantly different between groups. Over a median follow-up of 3.3 years, 1 patient in the SKS group and 3 patients in the crush group died (P = ns). Probable stent thrombosis leading to death according to the Academic Research Consortium definition occurred in 1 patient in the crush group. Mortality in the remaining 3 patients was noncardiac. Target lesion revascularization (TLR) occurred in 14 patients (40%) in the SKS group and 5 patients (12.8%) in the crush group (P = 0.015). Survival free from major adverse cardiac events (MACE) was significantly less in the SKS group and predominantly driven by TLR (60 vs. 88%, P = 0.001). CONCLUSIONS: In conclusion, over a median of 3.3 years of follow-up, TLR and MACE are significantly lower in bifurcation lesions treated with the crush technique when compared with the SKS technique. Definite or probable stent thrombosis is rare with either technique.

Prognostic significance of post-clopidogrel platelet reactivity assessed by a point-of-care assay on thrombotic events after drug-eluting stent implantation.

AIMS: The aim of this study was to determine whether platelet reactivity on clopidogrel therapy, as measured by a point-of-care platelet function assay, is associated with thrombotic events after percutaneous coronary intervention (PCI) with drug-eluting stents (DESs). METHODS AND RESULTS: Platelet reactivity on clopidogrel (post-treatment reactivity) was measured with the VerifyNow P2Y12 assay (Accumetrics Inc., San Diego, CA, USA) in 380 patients undergoing PCI with sirolimus-eluting stents. Receiver-operating characteristic curve analysis was used to derive the optimal cut-off value for post-treatment reactivity in predicting 6 month out-of-hospital cardiovascular (CV) death, non-fatal MI, or stent thrombosis. The mean post-treatment reactivity was 184 +/- 85 PRU (P2Y12 reaction units). The optimal cut-off for the combined endpoint was a post-treatment reactivity > or =235 PRU [area under the curve 0.711 (95% confidence interval 0.529-0.893), P = 0.03], which was similar to the threshold of the upper tertile (231 PRU). Patients with post-treatment reactivity greater than the cut-off value had significantly higher rates of CV death (2.8 vs. 0%, P = 0.04), stent thrombosis (4.6 vs. 0%, P = 0.004), and the combined endpoint (6.5 vs. 1.0%, P = 0.008). CONCLUSION: High post-treatment platelet reactivity measured with a point-of-care platelet function assay is associated with post-discharge events after PCI with DES, including stent thrombosis. Investigation of alternative clopidogrel dosing regimens to reduce ischaemic events in high-risk patients identified by this assay is warranted.

A new proposed simplified classification of coronary artery bifurcation lesions and bifurcation interventional techniques.

Current classification systems of coronary bifurcation lesions are confusing and difficult to memorize. As coronary revascularization techniques become increasingly complex, it is important to establish a universal classification system. This manuscript proposes a simplified classification system that uses a combination of letters and numbers to provide a clinically relevant anatomic description of a given coronary artery bifurcation lesion. This classification consists of the prefix B (for Bifurcation lesion), followed by the addition of 4 separate suffixes. The first suffix consists of one of the letters C, N, S, or L. C = Close to the bifurcation: the lesion is close to a bifurcation, but the distance from the carina is more than the width of the plaque protruding into the lumen; N = Bifurcation lesion with one branch being Nonsignificant: nonsignificant being defined as less than 2.0 mm vessel diameter; S = Small proximal segment; or L = Large proximal segment: large defined as more than two-thirds of the sum of the diameters of both branch vessels. The second suffix describes the number of diseased ostia. 1M = only the Main vessel ostium is involved; 1S = only the Side branch ostium is involved; or 2 = both ostia are involved. The third suffix classifies the angle between the bifurcation vessels and uses the letters V or T; V = the angle between the two branches is less than 70 degrees, T = angle more than 70 degrees. The fourth suffixes are optional: CA for calcified, LM for left main involvement.

Impaired myocardial SPECT imaging secondary to silicon- and saline-containing breast implants.

Early detection of coronary artery disease (CAD) in women has been challenging. Women are more likely to present with atypical symptoms, and non-invasive evaluation for CAD has been less accurate. Myocardial SPECT imaging is a well-established technique that provides important physiologic, anatomic, and prognostic information in women. Attenuation artifacts secondary to breast tissue are a common problem in women and can lead to decreased specificity of gated SPECT imaging. Cosmetic breast implants are increasing in popularity. The presence of a foreign object overlying the anterior wall of the heart in addition to native breast tissue can significantly increase attenuation artifacts. There is only one report to date describing attenuation artifact due to silicon breast implants in comparison to control, and there are no reports regarding saline breast implants. Here we report three cases of impaired myocardial SPECT imaging in women with breast implants: one patient with silicone implants, and two with saline-containing implants. Clinicians should be aware of this problem and women should be educated regarding the potential future diagnostic problems that may occur with breast implants before considering this cosmetic surgery.

Delayed spontaneous recanalization of a totally occluded right coronary artery following failed percutaneous coronary intervention with associated Type F dissection: case report and review.

Coronary artery dissection is a well-known and frequent complication of percutaneous coronary intervention (PCI). We report the first case of a Type F dissection following PCI of the distal right coronary artery causing total vessel occlusion that could not be stented but was associated with late spontaneous recanalization and a favorable outcome.