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Agreement of the Resting Distal to Aortic Coronary Pressure With the Instantaneous Wave-Free Ratio
AbstractBackground

Recently, 2 randomized controlled trials showed that the instantaneous wave-free ratio (iFR), a resting coronary physiological index, is noninferior to fractional flow reserve for guiding revascularization. The resting distal to aortic coronary pressure (Pd/Pa) measured at rest is another adenosine-free index widely available in the cardiac catheterization laboratory; however, little is known about the agreement of Pd/Pa using iFR as a reference standard.

Objectives

The goal of this study was to investigate the agreement of Pd/Pa with iFR.

Methods

A total of 763 patients were prospectively enrolled from 12 institutions. iFR and Pd/Pa were measured under resting conditions. Using iFR ≤0.89 as a reference standard, the agreement of Pd/Pa and its best cutoff value were assessed.

Results

According to the independent core laboratory analysis, iFR and Pd/Pa were analyzable in 627 and 733 patients (82.2% vs. 96.1%; p < 0.001), respectively. The median iFR and Pd/Pa were 0.90 (interquartile range: 0.85 to 0.94) and 0.92 (interquartile range: 0.88 to 0.95), and the 2 indices were highly correlated (R2 = 0.93; p < 0.001; iFR = 1.31 * Pd/Pa –0.31). According to the receiver-operating characteristic curve analysis, Pd/Pa showed excellent agreement (area under the curve: 0.98; 95% confidence interval: 0.97 to 0.99; p < 0.001) with a best cutoff value of Pd/Pa ≤0.91. The diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value were 93.0%, 91.4%, 94.4%, 93.3%, and 92.7%, respectively. These results were similar in patients with acute coronary syndrome and stable angina.

Conclusions

Pd/Pa was analyzable in a significantly higher number of patients than iFR. Pd/Pa showed excellent agreement with iFR, suggesting that it could be applied clinically in a similar fashion. (Can Contrast Injection Better Approximate FFR Compared to Pure Resting Physiology? [CONTRAST]; NCT02184117)





Similarity and Difference of Resting Distal to Aortic Coronary Pressure and Instantaneous Wave-Free Ratio
AbstractBackground

Instantaneous wave-free ratio (iFR) has been used in clinical practice to identify functionally significant stenosis and to guide treatment strategy. However, there are limited clinical data regarding another resting pressure-derived index, resting distal to aortic coronary pressure (Pd/Pa), and similarities and differences between resting Pd/Pa and iFR.

Objectives

The authors investigated the changes in resting Pd/Pa and iFR according to anatomic and hemodynamic stenosis severity and their prognostic implications.

Methods

From the 3V FFR-FRIENDS (Clinical Implication of 3-vessel Fractional Flow Reserve) and the IRIS-FFR (Study of the Natural History of FFR Guided Percutaneous Coronary Intervention) studies, 1,024 vessels (n = 435) with available pre-intervention resting Pd/Pa and iFR were used to explore the changes in resting physiological indices according to percent diameter stenosis. Among 115 patients who underwent 13N-ammonia positron emission tomography, the changes in those indices according to basal and hyperemic stenosis resistance and absolute hyperemic myocardial blood flow were compared. The association between physiological indices and the risk of 2-year major adverse cardiac events (MACE) (a composite of cardiac death, myocardial infarction, and ischemia-driven revascularization) were analyzed among 375 deferred patients.

Results

There was a significant linear correlation between resting Pd/Pa and iFR (R = 0.970; p < 0.001, iFR = 1.370 x resting Pd/Pa – 0.370). Both resting Pd/Pa and iFR changed significantly according to percent diameter stenosis, basal and hyperemic stenosis resistance, and hyperemic absolute myocardial blood flow (all p values <0.001). Percent difference of iFR according to the increase in anatomic and hemodynamic severity was higher than that of resting Pd/Pa. Both resting Pd/Pa and iFR showed a significant association with the risk of 2-year MACE (resting Pd/Pa hazard ratio [per 0.10 increase]: 0.480; 95% confidence interval: 0.250 to 0.923; p = 0.027; iFR hazard ratio [per 0.1 increase]: 0.586; 95% confidence interval: 0.373 to 0.919; p = 0.020) in deferred patients. However, the difference between the upper- and lower-bound estimated MACE rates according to the approximate measurement variability of each index was significantly higher with resting Pd/Pa compared with iFR (resting Pd/Pa 3.85 ± 4.00% and iFR 3.27 ± 3.39%; p < 0.001).

Conclusions

Both resting Pd/Pa and iFR showed similar associations with anatomic and hemodynamic stenosis severity and the risk of MACE. However, iFR was more sensitive to the difference in stenosis severity and showed a lower maximum difference in estimated MACE risk influenced by the measurement variability compared with resting Pd/Pa. (Clinical Implication of 3-Vessel Fractional Flow Reserve [3V FFR-FRIENDS]; NCT01621438; and Study of the Natural History of FFR Guided Percutaneous Coronary Intervention [IRIS-FFR]; NCT01366404)





Agreement and Differences Among Resting Coronary Physiological Indices: Are All Things Equal?




The PCSK9-LDL Receptor Axis and Outcomes in Heart Failure: BIOSTAT-CHF Subanalysis
AbstractBackground

Proprotein convertase subtilisin/kexin type 9 (PCSK9) binds low-density lipoprotein receptor (LDLR), preventing its recycling. PCSK9 is a risk predictor and a biotarget in atherosclerosis progression.

Objectives

The aim of this study was to determine whether the PCSK9-LDLR axis could predict risk in patients with heart failure (HF).

Methods

The BIOSTAT-CHF (Biology Study to Tailored Treatment in Chronic Heart Failure) is a multicenter, multinational, prospective, observational study that included patients with worsening HF signs and/or symptoms. The primary endpoints were all-cause mortality and the composite of mortality or unscheduled hospitalizations for HF. We implemented Cox proportional hazard regression to determine the simultaneously adjusted effect of PCSK9 and LDLR on both outcomes when added to the previously validated BIOSTAT-CHF risk scores.

Results

This study included 2,174 patients (mean age: 68 ± 12 years; 53.2% had a history of ischemic heart disease). Median (interquartile range) PCSK9 and LDLR levels were 1.81 U/ml (1.45 to 2.18) and 2.98 U/ml (2.45 to 3.53), respectively. During follow-up, 569 deaths (26.2%) and 896 (41.2%) composite endpoints were ascertained. A multivariable analysis, which included BIOSTAT-CHF risk scores, LDLR, and statin treatment as covariates, revealed a positive linear association between PCSK9 levels and the risk of mortality (hazard ratio [HR]: 1.24; 95% confidence interval [CI]: 1.04 to 1.49; p = 0.020) and the composite endpoint (HR: 1.21; 95% CI: 1.05 to 1.40; p = 0.010). A similar analysis for LDLR revealed a negative association with mortality (HR: 0.86; 95% CI: 0.76 to 0.98; p = 0.025) and the composite endpoint (HR: 0.92; 95% CI: 0.83 to 1.01; p = 0.087). Including PCSK9 and LDLR improved risk score performance.

Conclusions

The PCSK9-LDLR axis was associated with outcomes in patients with HF. Future studies must assess whether PCSK9 inhibition will result in better outcomes in HF.





Cholesterol and Heart Failure: Is There an Important Connection?




Renal Sympathetic Denervation Protects the Failing Heart Via Inhibition of Neprilysin Activity in the Kidney
AbstractBackground

Sustained sympathetic activation contributes to the progression of myocardial cell injury, cardiac fibrosis, and left ventricular (LV) dysfunction in heart failure (HF).

Objectives

This study investigated the effects of radiofrequency renal nerve denervation (RF-RDN) on the pathobiology of HF and the interaction between the renal sympathetic nerves and natriuretic peptide (NP) metabolism.

Methods

Spontaneously hypertensive rats (SHR) and normotensive Wistar-Kyoto rats (WKY) were subjected to 45 min of coronary artery ligation and reperfusion for 12 weeks. At 4 weeks post-reperfusion, SHR and WKY underwent either bilateral RF-RDN or sham-RDN.

Results

Following RF-RDN in both strains, LV ejection fraction remained significantly above those levels in respective sham-RDN rats, and at the end of the 12-week study, rats in both strains had significantly reduced LV fibrosis and improved vascular function. RF-RDN therapy significantly improved vascular reactivity to endothelium-dependent and -independent vasodilators as well as vascular compliance in the setting of severe HF. Improvements in LV function were accompanied by significant elevations in circulating NP as compared to those associated with sham-RDN. Further investigation into the cause of increased circulating NP levels demonstrated that RF-RDN significantly inhibited renal neprilysin activity in SHR and WKY with HF. Likewise, chronic treatment with the beta1 antagonist bisoprolol inhibited renal neprilysin activity and increased circulation NP levels in WKY with HF.

Conclusions

This study identifies a novel endogenous pathway by which the renal nerves participate in the degradation of cardioprotective NP. Furthermore, removal of the influence of the renal nerves on kidney function attenuates renal neprilysin activity, augments circulating NP levels, reduces myocardial fibrosis, and improves LV function in the setting of HF.





Neprilysin and Heart Failure: A "Sympathetic" Relationship?




A Missense Variant in PLEC Increases Risk of Atrial Fibrillation
AbstractBackground

Genome-wide association studies (GWAS) have yielded variants at >30 loci that associate with atrial fibrillation (AF), including rare coding mutations in the sarcomere genes MYH6 and MYL4.

Objectives

The aim of this study was to search for novel AF associations and in doing so gain insights into the mechanisms whereby variants affect AF risk, using electrocardiogram (ECG) measurements.

Methods

The authors performed a GWAS of 14,255 AF cases and 374,939 controls, using whole-genome sequence data from the Icelandic population, and tested novel signals in 2,002 non-Icelandic cases and 12,324 controls. They then tested the AF variants for effect on cardiac electrical function by using measurements in 289,297 ECGs from 62,974 individuals.

Results

The authors discovered 2 novel AF variants, the intergenic variant rs72700114, between the genes LINC01142 and METTL11B (risk allele frequency = 8.1%; odds ratio [OR]: 1.26; p = 3.1 x 10–18), and the missense variant p.Gly4098Ser in PLEC (frequency = 1.2%; OR: 1.55; p = 8.0 x 10–10), encoding plectin, a cytoskeletal cross-linking protein that contributes to integrity of cardiac tissue. The authors also confirmed 29 reported variants. p.Gly4098Ser in PLEC significantly affects various ECG measurements in the absence of AF. Other AF variants have diverse effects on the conduction system, ranging from none to extensive.

Conclusions

The discovery of a missense variant in PLEC affecting AF combined with recent discoveries of variants in the sarcomere genes MYH6 and MYL4 points to an important role of myocardial structure in the pathogenesis of the disease. The diverse associations between AF variants and ECG measurements suggest fundamentally different categories of mechanisms contributing to the development of AF.





The Com-PLEC-sity of Atrial Fibrillation Genetics




How Low to Go With Glucose, Cholesterol, and Blood Pressure in Primary Prevention of CVD
Abstract

Diabetes, hyperlipidemia, and hypertension are modifiable risk factors that predict cardiovascular disease events. The effect of these risk factors on incident cardiovascular disease increases with progressively higher levels of glucose, low-density lipoprotein cholesterol, and blood pressure. The thresholds for initiating treatment of these modifiable risk factors and the optimal goals of risk factor modification are a focus of primary prevention research. Although an aggressive approach is appealing, adverse events may occur, and potential physiological barriers may exist. This paper discusses primary prevention of coronary heart disease that may be achieved through modification of diabetes, hyperlipidemia, and hypertension by summarizing current guidelines and pertinent clinical trial data from intervention trials that included a primary prevention cohort.





Biological Phenotypes of Heart Failure With Preserved Ejection Fraction
Abstract

Heart failure with preserved ejection fraction (HFpEF) involves multiple pathophysiological mechanisms, which result in the heterogeneous phenotypes that are evident clinically, and which have potentially confounded previous HFpEF trials. A greater understanding of the in vivo human processes involved, and in particular, which are the causes and which are the downstream effects, may allow the syndrome of HFpEF to be distilled into distinct diagnoses based on the underlying biology. From this, specific interventions can follow, targeting individuals identified on the basis of their biological phenotype. This review describes the biological phenotypes of HFpEF and therapeutic interventions aimed at targeting these phenotypes.





Cardiovascular Medicine Amid Evolving Health Policy: Time to Train a Generation of Policy Leaders




Arterial Dissection as a Cause of Intracranial Stenosis in East Asians




New Criteria for LVH Should Be Evaluated Against Age




Reply: New Criteria for LVH Should Be Evaluated Against Age




The Optimal Duration of Dual-Antiplatelet Therapy After Coronary Stenting: Shorter or Longer?




Reply: The Optimal Duration of Dual-Antiplatelet Therapy After Coronary Stenting: Shorter or Longer?




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JACC: Cardiovascular Interventions recent issues

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Simultaneous TAVR and Left Main "Chimney" Stenting in a Patient With Low Left Main Height




Treatment of an Acute Limb Due to Inferior Vena Cava Filter Thrombosis




3-Dimensional SPECT/CT Fusion Imaging-Guided Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension




Associations Between Chronic Kidney Disease and Outcomes With Use of Prasugrel Versus Clopidogrel in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: A Report From the PROMETHEUS Study
AbstractObjectives

This study sought to compare clinical outcomes in a contemporary acute coronary syndrome (ACS) percutaneous coronary intervention (PCI) cohort stratified by chronic kidney disease (CKD) status.

Background

Patients with CKD exhibit high risks for both thrombotic and bleeding events, thus complicating decision making regarding antiplatelet therapy in the setting of ACS.

Methods

The PROMETHEUS study was a multicenter observational study comparing outcomes with prasugrel versus clopidogrel in ACS PCI patients. Major adverse cardiac events (MACE) at 90 days and at 1 year were defined as a composite of death, myocardial infarction, stroke, or unplanned revascularization. Clinically significant bleeding was defined as bleeding requiring transfusion or hospitalization. Cox regression multivariable analysis was performed for adjusted associations between CKD status and clinical outcomes. Hazard ratios for prasugrel versus clopidogrel treatment were generated using propensity score stratification.

Results

The total cohort included 19,832 patients, 28.3% with and 71.7% without CKD. CKD patients were older with greater comorbidities including diabetes and multivessel disease. Prasugrel was less often prescribed to CKD versus non-CKD patients (11.0% vs. 24.0%, respectively; p < 0.001). At 1 year, CKD was associated with higher adjusted risk of MACE (1.27; 95% confidence interval: 1.18 to 1.37) and bleeding (1.46; 95% confidence interval: 1.24 to 1.73). Although unadjusted rates of 1-year MACE were lower with prasugrel versus clopidogrel in both CKD (18.3% vs. 26.5%; p < 0.001) and non-CKD (10.9% vs. 17.9%; p < 0.001) patients, associations were attenuated after propensity stratification. Similarly, unadjusted differences in 1-year bleeding with prasugrel versus clopidogrel (6.0% vs. 7.4%; p = 0.18 in CKD patients; 2.6% vs. 3.5%; p = 0.008 in non-CKD patients) were not significant after propensity score adjustment.

Conclusions

Although risks for 1-year MACE were significantly higher in ACS PCI patients with versus without CKD, prasugrel use was 50% lower in patients with renal impairment. Irrespective of CKD status, outcomes associated with prasugrel use were not significant after propensity adjustment. These data highlight the need for randomized studies evaluating the optimal antiplatelet therapy in CKD patients with ACS.





P2Y12 Inhibitors in Patients With Chronic Kidney Disease: The Known Unknown




The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes
AbstractObjectives

The aim of this first-in-human study was to assess the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR).

Background

Angioplasty balloons coated with the cytotoxic drug paclitaxel have been widely used for ISR treatment. The Virtue angioplasty balloon (Caliber Therapeutics, New Hope, Pennsylvania) delivers sirolimus in a nanoencapsulated liquid formulation. This clinical trial is the first to examine a sirolimus-eluting balloon for ISR.

Methods

In this prospective, single-arm feasibility study at 9 European centers, 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months are reported, along with 12-month clinical follow-up.

Results

Procedural success in the intention-to-treat population was 100%. The primary safety endpoint was target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) assessed at 30 days (0%, n = 50). The primary performance endpoint was in-segment late lumen loss (LLL) at 6 months (0.31 ± 0.52 mm; n = 47). Secondary 6-month endpoints include binary restenosis (19.1%), diameter stenosis (30.3 ± 19.9%), and major adverse cardiac events (MACE) (10.2%, n = 49). In the 36-patient per-protocol population (excluding major protocol violations and previously stented ISR), LLL was 0.12 ± 0.33 mm at 6 months. Clinical outcomes at 1 year for the intention-to-treat group were 12.2% TLF and 14.3% MACE and for the per-protocol population were 2.8% TLF and 2.8% MACE.

Conclusions

This first-in-human study showed excellent procedural success for the Virtue sirolimus-eluting angioplasty balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes that warrant further evaluation in dedicated randomized studies.





The Debut of Sirolimus-Eluting Balloons: The Final Nail in the Coffin for In-Stent Restenosis?




Dialysis Following Transcatheter Aortic Valve Replacement: Risk Factors and Outcomes: An Analysis From the UK TAVI (Transcatheter Aortic Valve Implantation) Registry
AbstractObjectives

This study sought to determine the risk factors for post-transcatheter aortic valve replacement (TAVR) dialysis and to determine the impact of pre-TAVR or post-TAVR dialysis on mortality.

Background

TAVR is now established as an alternative treatment to surgical aortic valve replacement. Data examining the impact of dialysis on outcomes after TAVR are lacking.

Methods

The UK TAVI (Transcatheter Aortic Valve Implantation) Registry was established to report outcomes on all TAVR procedures performed within the United Kingdom (2007 to 2014). Data were collected prospectively on 6,464 patients with a median follow-up of 625 days.

Results

The proportion of patients on dialysis before TAVR has remained constant at 1.8%. After TAVR, the proportion of patients newly needing dialysis after TAVR has fallen from 6.1% (2007 to 2008) to 2.3% (2013 to 2014). The risk of new dialysis requirement after TAVR was independently associated with lower baseline renal function, year of procedure, impaired left ventricular function, diabetes, use of an Edwards valve, a nontransfemoral approach, need for open surgery, and moderate-to-severe aortic regurgitation after the procedure. Requirement for new dialysis after TAVR was associated with higher mortality at 30 days (hazard ratio: 6.44; 95% confidence interval: 4.87 to 8.53) and at 4 years (hazard ratio: 3.54; 95% confidence interval: 2.99 to 4.19; p < 0.001 for all) compared with patients without dialysis requirement.

Conclusions

The proportion of patients needing dialysis after TAVR has decreased over time. Post-TAVR dialysis is associated with increased mortality. Factors identified with dialysis requirement after TAVR require further investigation.





The Relationship of Dialysis Risk and Transcatheter Aortic Valve Replacement From the UK TAVI Registry: Study Findings: Some Expected, Some Provocative




Association of Chronic Kidney Disease With In-Hospital Outcomes of Transcatheter Aortic Valve Replacement
AbstractObjectives

This study sought to determine the association of chronic kidney disease (CKD) with in-hospital outcomes of transcatheter aortic valve replacement (TAVR).

Background

CKD is a known independent risk factor for worse outcomes after surgical aortic valve replacement (SAVR). However, data on outcomes of patients with CKD undergoing TAVR are limited, especially in those on chronic dialysis.

Methods

The authors used data from the 2012 to 2014 National Inpatient Sample database to identify all patients ≥18 years of age who underwent TAVR. International Classification of Diseases-Ninth Revision-Clinical Modification codes were used to identify patients with no CKD, CKD (without chronic dialysis), or end-stage renal disease (ESRD) on long-term dialysis. Multivariable logistic regression models were constructed using generalized estimating equations to examine in-hospital outcomes.

Results

Of 41,025 patients undergoing TAVR from 2012 to 2014, 25,585 (62.4%) had no CKD, 13,750 (33.5%) had CKD, and 1,690 (4.1%) had ESRD. Compared with patients with no CKD, in-hospital mortality was significantly higher in patients with CKD or ESRD (3.8% vs. 4.5% vs. 8.3%; adjusted odds ratio [no CKD as reference]: 1.39 [95% confidence interval: 1.24 to 1.55] for CKD and 2.58 [95% confidence interval: 2.09 to 3.13] for ESRD). Patients with CKD or ESRD had a higher incidence of major adverse cardiovascular events (composite of death, myocardial infarction, or stroke), net adverse cardiovascular events (composite of major adverse cardiovascular events, major bleeding, or vascular complications), and pacemaker implantation compared with patients without CKD. Acute kidney injury (AKI) and AKI requiring dialysis were associated with several-fold higher risk-adjusted in-hospital mortality in patients in the no CKD and CKD groups. Moreover, the incidence of AKI and AKI requiring dialysis did not decline during the study period.

Conclusions

Patients with CKD or ESRD have worse in-hospital outcomes after TAVR. AKI is associated with higher in-hospital mortality in patients undergoing TAVR and the incidence of AKI has not declined over the years.





Fixing the Valve, But Injuring the Kidneys, With Transcatheter Aortic Valve Replacement: Collateral Damage With Serious Consequences




Death and Dialysis After Transcatheter Aortic Valve Replacement: An Analysis of the STS/ACC TVT Registry
AbstractObjectives

The authors sought to elucidate the true incidence of renal replacement therapy (RRT) after transcatheter aortic valve replacement (TAVR).

Background

There is a wide discrepancy in the reported rate of RRT after TAVR (1.4% to 40%). The true incidence of RRT after TAVR is unknown.

Methods

The STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) registry was linked to the Centers for Medicare & Medicaid database to identify all patients that underwent TAVR from November 2011 through September 2015 and their outcomes. The authors compared rates of death, new RRT, and a composite of both as a function of pre-procedure glomerular filtration rate (GFR), both in stages of chronic kidney disease (CKD), as well as on a continuous scale.

Results

Pre-procedure GFR is associated with the risk of death and new RRT after TAVR when GFR is <60 ml/min/m2, and increases significantly when GFR falls below 30 ml/min/m2. Incremental increases in GFR of 5 ml/min/m2 were statistically significant (unadjusted hazard ratio: 0.71; p < 0.001) at 30 days, and continued to be significant at 1 year when pre-procedure GFR was <60 ml/min/m2. One in 3 CKD stage 4 patients will be dead within 1 year, with 14.6% (roughly 1 in 6) requiring dialysis. In CKD stage 5, more than one-third of patients will require RRT within 30 days; nearly two-thirds will require RRT at 1 year.

Conclusions

In both unadjusted and adjusted analysis, pre-procedural GFR was associated with the outcomes of death and new RRT. Increasing CKD stage leads to an increased risk of death and/or RRT. Continuous analysis showed significant differences in outcomes in all levels of CKD when GFR was <60 ml/min/m2. Pre-procedure GFR should be considered when selecting CKD patients for TAVR.





The Plan Was to Replace the Valve, Not the Kidneys




Multicenter Comparison of Novel Self-Expanding Versus Balloon-Expandable Transcatheter Heart Valves
AbstractObjectives

This study sought to compare 2 next-generation transcatheter heart valves (THV), the self-expanding ACURATE neo (NEO) and the balloon-expandable SAPIEN 3 (S3), in terms of device failure and early safety at 30 days.

Background

Deployment of these THV showed promising initial clinical results. However, no comparative data are available.

Methods

Of 1,121 treated patients at 3 centers, a 1-to-2 nearest neighbor matching was performed to identify 2 patients treated with S3 (n = 622) for each patient treated with NEO (n = 311).

Results

In-hospital complications were comparable between NEO and S3, including stroke (1.9% vs. 2.4%; p = 0.64), major vascular complications (10.3% vs. 8.5%; p = 0.38), or life-threatening bleeding (4.2% vs. 3.7%; p = 0.72). Device failure with NEO was comparable with S3 (10.9% vs. 9.6%; odds ratio: 1.09 [95% confidence interval: 0.69 to 1.73]; p = 0.71) with more paravalvular leakage (PVL II+, 4.8% vs. 1.8%; p = 0.01), but less elevated gradients (≥20 mm Hg, 3.2% vs. 6.9%; p = 0.02) and pacemaker implantations (9.9% vs. 15.5%; p = 0.02). Thirty-day mortality (2.3% vs. 1.9%; p = 0.74) and the early safety composite endpoint (15.8% vs. 15.6%; hazard ratio: 0.97 [95% confidence interval: 0.68 to 1.39]; p = 0.88) were similar with NEO and S3.

Conclusions

Very high success rates were achieved for both valves, and the clinical and procedural results were comparable. Compared with S3, NEO was associated with less new pacemaker implantations and less elevated gradients, but with more paravalvular leakage.





A Comparison of the ACURATE Neo and Sapien 3 Valves: Making Progress




Outcomes for the Commercial Use of Self-Expanding Prostheses in Transcatheter Aortic Valve Replacement: A Report From the STS/ACC TVT Registry
AbstractObjectives

The authors sought to compare the outcomes of commercial transcatheter aortic valve replacement (TAVR) with the repositionable Evolut R platform to those observed with the CoreValve device in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry.

Background

TAVR continues to evolve, with rapid adoption of iterative changes for commercial practice. Insight into the outcomes of this adoption is needed.

Methods

Patients in the TVT Registry who had TAVR using a 23-, 26-, or 29-mm self-expanding prosthesis were enrolled. Site-reported events for procedural, in-hospital, and 30-day outcomes were examined.

Results

Between January 2014 and April 2016, 9,616 patients underwent TAVR with a self-expanding prosthesis with data entered in the TVT Registry. Compared with patients treated with CoreValve TAVR, those who received Evolut R TAVR had a lower STS-PROM score (8.0 ± 5.4% vs. 8.7 ± 5.3%; p < 0.001), more iliofemoral access (91.6% vs. 89.2%; p < 0.001), and more frequently had conscious sedation (27.4% vs. 12.7%; p < 0.001). With Evolut R TAVR, there was less need for a second prosthesis (2.2% vs. 4.5%; p < 0.001), less device migration (0.2% vs. 0.6%; p = 0.01), a lower incidence of moderate/severe paravalvular regurgitation (post-procedure, 4.4% vs. 6.2%; p < 0.001), and shorter median hospital stay (4.0 vs. 5.0 days; p < 0.001). Patients treated with Evolut R TAVR had greater device success (96.3% vs. 94.9%; p = 0.001). At 30 days, Evolut R patients had both lower mortality (3.7% vs. 5.3%; p < 0.001) and less need for a pacemaker (18.3% vs. 20.1%; p = 0.03).

Conclusions

Commercial adoption of the Evolut R platform is associated with significant improvements in acute outcomes for patients undergoing TAVR for aortic stenosis.





The Results of Transcatheter Aortic Valve Replacement Continue to Improve: The Specific Example of a Self-Expandable Transcatheter Heart Valve in a Real-Life Registry




Nationwide Trends in Hospital Outcomes and Utilization After Lower Limb Revascularization in Patients on Hemodialysis
AbstractObjectives

This study aimed to describe the temporal trends and outcomes of endovascular and surgical revascularization in a large, nationally representative sample of patients with end-stage renal disease on hemodialysis hospitalized for peripheral artery disease (PAD).

Background

PAD is prevalent among patients with end-stage renal disease on hemodialysis and is associated with significant morbidity and mortality. There is a paucity of information on trends in endovascular and surgical revascularization and post-procedure outcomes in this population.

Methods

We used the Nationwide Inpatient Sample (2002 to 2012) to identify hemodialysis patients undergoing endovascular or surgical procedures for PAD using diagnostic and procedural codes. We compared trends in amputation, post-procedure complications, mortality, length of stay, and costs between the 2 groups using trend tests and logistic regression.

Results

There were 77,049 endovascular and 29,556 surgical procedures for PAD in hemodialysis patients. Trend analysis showed that endovascular procedures increased by nearly 3-fold, whereas there was a reciprocal decrease in surgical revascularization. Post-procedure complication rates were relatively stable in persons undergoing endovascular procedures but nearly doubled in those undergoing surgery. Surgery was associated with 1.8 times adjusted odds (95% confidence interval: 1.60 to 2.02) for complications and 1.6 times the adjusted odds for amputations (95% confidence interval: 1.40 to 1.75) but had similar mortality (adjusted odds ratio: 1.05; 95% confidence interval: 0.85 to 1.29) compared with endovascular procedures. Length of stay for endovascular procedures remained stable, whereas a decrease was seen for surgical procedures. Overall costs increased marginally for both procedures.

Conclusions

Rates of endovascular procedures have increased, whereas those of surgeries have decreased. Surgical revascularization is associated with higher odds of overall complications. Further prospective studies and clinical trials are required to analyze the relationship between the severity of PAD and the revascularization strategy chosen.





Trends in Lower Limb Revascularization Among Patients With End-Stage Renal Failure: Where Is the Journey Going, and How Far Have We Come?




Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The IN.PACT Global Study De Novo In-Stent Restenosis Imaging Cohort
AbstractObjectives

This study sought to evaluate the safety and effectiveness of a paclitaxel-coated drug-coated balloon (DCB) for the treatment of patients with de novo in-stent restenosis (ISR).

Background

Treatment of patients with ISR remains a challenge. Current strategies are plagued by high rates of recurrent restenosis and need for reintervention. The best intervention for ISR remains to be elucidated.

Methods

The IN.PACT Global study is an independently adjudicated multicenter, prospective, single-arm study that enrolled 1,535 subjects with symptomatic atherosclerotic disease of the superficial femoral and/or popliteal arteries, including de novo ISR lesions. Patients enrolled in the pre-specified ISR imaging cohort were evaluated for vessel patency and reintervention within the 12-month follow-up period.

Results

A total of 131 subjects with 149 ISR lesions were included for analysis. The mean age of the cohort was 67.8 years. Mean lesion length was 17.17 ± 10.47 cm, including 34.0% total occlusions and 59.1% calcified lesions. The 12-month Kaplan-Meier estimate of primary patency was 88.7%. The rate of clinically driven target lesion revascularization (CD TLR) at 12 months was 7.3%. The primary safety outcome, a composite of freedom from device- and procedure-related mortality through 30 days and freedom from major target limb amputation and CD TLR within 12 months, was 92.7%. There were no major target limb amputations, no deaths, and a low (0.8%) thrombosis rate.

Conclusions

Results from the ISR imaging cohort demonstrate high patency and a low rate of CD TLR at 12 months. These data confirm the safety and effectiveness of the IN.PACT Admiral DCB (Medtronic, Dublin, Ireland) in complex femoropopliteal lesions, including this challenging subset.





Challenges of Stent Restenosis in Superficial Femoral and Popliteal Artery Disease




Transcatheter Closure of Aortic Anastomosis Leak Resulting in Patent Cabrol Shunt After Aortic Replacement




Percutaneous Treatment of a Giant Infected Femoral Artery Pseudoaneurysm




Successful Prevention of Inappropriate Cardiac Catheterizations by an Educational and Screening Program in a Tertiary Cardiac Referral Center




One Mans Vacation, Another Mans Stress Test




Grabbing the Transcatheter Valve Skirt: Bail-Out Technique for Valve Embolization During Valve-in-Valve Transcatheter Mitral Valve Replacement




Transfemoral Implantation of a Balloon-Expandable Transcatheter Valve in a Rigid Mitral Annuloplasty Ring Optimized by Post-Dilatation




Mitral Annuloplasty Ring Fracture and Annular Injury During Transcatheter Mitral Valve-in-Ring Intervention




Transseptal Transcatheter Mitral Valve Replacement Using Balloon-Expandable Transcatheter Heart Valves: A Step-by-Step Approach
Abstract

Transcatheter mitral valve replacement (TMVR) using balloon-expandable valves has become an alternative therapy for selected patients with mitral valve disease. Up to now, the transapical approach has been the preferred route, but the transseptal approach is becoming increasingly popular due to its reduced invasiveness and increased safety. However, transseptal TMVR procedures are technically challenging, and little is known about the screening process required before this therapy. The authors provide operators with a step-by-step approach from the screening process to follow-up care for transseptal TMVR procedures.





Impact of Frailty on Outcomes in Patients Undergoing Percutaneous Mitral Valve Repair
AbstractObjectives

The aim of this study was to describe the impact of frailty in patients undergoing percutaneous mitral valve repair (PMVR).

Background

Frailty is common in elderly patients and those with comorbidities and is associated with adverse prognosis.

Methods

Frailty according to the Fried criteria was assessed in consecutive patients admitted for PMVR. Associations of frailty with 6-week (device success, changes in 6-min walking distance and Minnesota Living With Heart Failure Questionnaire and Short Form 36 physical and mental component scores, and improvement ≥1 New York Heart Association functional class) and long-term outcomes during a median follow-up period of 429 days were examined.

Results

Of 213 patients admitted for PMVR (median age 78 years; age range 50 to 95 years; 57.3% men), 45.5% were classified as frail. Compared with nonfrail patients, frail patients had a similar device success rate (81.4% vs. 84.5%; p = 0.56) and improvement in 6-min walking distance, New York Heart Association functional class, and Short Form-36 scores but a more pronounced improvement in Minnesota Living With Heart Failure Questionnaire score (mean change –15.9 vs. –11.2 points; p = 0.002). Mortality at 6 weeks was significantly higher in frail (8.3%) compared with nonfrail (1.7%) patients (p = 0.03). Hazards of death (hazard ratio: 3.06; 95% confidence interval: 1.54 to 6.07; p = 0.001) and death or heart failure decompensation (hazard ratio: 2.03; 95% confidence interval: 1.22 to 3.39; p = 0.007) were significantly increased in frail patients during long-term follow-up, which did not change relevantly after adjustment for European System for Cardiac Operative Risk Evaluation score and N-terminal pro–brain natriuretic peptide level.

Conclusions

PMVR can be performed with equal efficacy and is associated with at least similar short-term functional improvement in frail patients. These results support the continued use of PMVR in frail elderly patients with the goal of palliation of heart failure symptoms and improvement in quality of life.





Frail Elderly, the Ideal Patients for MitraClip




Early Outcomes of Percutaneous Transvenous Transseptal Transcatheter Valve Implantation in Failed Bioprosthetic Mitral Valves, Ring Annuloplasty, and Severe Mitral Annular Calcification
AbstractObjectives

The aim of this study was to examine 1-year outcomes of transseptal balloon-expandable transcatheter heart valve implantation in failed mitral bioprosthesis, ring annuloplasty, and mitral annular calcification (MAC).

Background

Immediate outcomes following transseptal mitral valve implantation in failed bioprostheses are favorable, but data on subsequent outcomes are lacking.

Methods

Percutaneous transseptal implantation of balloon-expandable transcatheter heart valves was performed in 87 patients with degenerated mitral bioprostheses (valve in valve [VIV]) (n = 60), previous ring annuloplasty (valve in ring) (n = 15), and severe MAC (valve in MAC) (n = 12).

Results

The mean Society of Thoracic Surgeons risk score was 13 ± 8%, and the mean age was 75 ± 11 years. Acute procedural success was achieved in 78 of 87 patients (90%) in the overall group and 58 of 60 (97%) in the VIV group, with a success rate of 20 of 27 (74%) in the valve in ring/valve in MAC group. Thirty-day survival free of death and cardiovascular surgery was 95% (95% confidence interval [CI]: 92% to 97%) in the VIV subgroup and 78% (95% CI: 70% to 86%) in the valve in ring/valve in MAC group (p = 0.008). One-year survival free of death and cardiovascular surgery was 86% (95% CI: 81% to 91%) in the VIV group compared with 68% (95% CI: 58% to 78%) (p = 0.008). At 1 year, 36 of 40 patients (90%) had New York Heart Association functional class I or II symptoms, no patients had more than mild residual mitral prosthetic or periprosthetic regurgitation, and the mean transvalvular gradient was 7 ± 3 mm Hg.

Conclusions

One-year outcomes following successful transseptal balloon-expandable transcatheter heart valve implantation in high-risk patients with degenerated mitral bioprostheses are excellent, characterized by durable symptom relief and prosthesis function. Although mitral valve in ring and valve in MAC have higher operative morbidity and mortality, 1-year outcomes after an initially successful procedure are favorable in carefully selected patients.





Transcatheter Aortic Valves for Failing Surgical Mitral Prostheses and Mitral Annular Calcification: Good From Far But Far From Good?




Transcatheter and Surgical Management of Mitral Paravalvular Leak: Long-Term Outcomes
AbstractObjectives

The aim of this study was to report the use trends and immediate and long-term outcomes of a large cohort of patients who underwent redo surgery or transcatheter repair of paravalvular leaks (PVLs) at a tertiary referral center.

Background

Percutaneous treatment of mitral PVL has emerged as an alternative to surgical treatment in high-risk surgical candidates. There are limited data on the utilization trends, safety, and efficacy of both procedures in the management of mitral PVL.

Methods

Patients who underwent treatment of mitral PVL at the Mayo Clinic between January 1995 and December 2015 were enrolled. Utilization trends, procedural details, technical success, and in-hospital and long-term outcomes were assessed.

Results

Three hundred eighty-one patients underwent percutaneous (n = 195) or surgical (n = 186) treatment of mitral PVLs. The mean age was 66 ± 12 years, and 37% of patients had bioprosthetic valves. Technical success was higher in the surgical group (95.5% vs. 70.1%; p < 0.001). In-hospital major adverse events were more common after surgery (22.5% vs. 7.7%; p < 0.001). In-hospital death occurred in 3.1% and 8.6% of patients undergoing percutaneous and surgical treatment, respectively (p = 0.027). However, in a multivariate logistic regression analysis, only active endocarditis, chronic renal failure, and severe mitral annular calcifications were significant predictors of in-hospital mortality. Reintervention rates were similar (11.3% vs. 17.2% in the percutaneous and surgical groups, respectively; p = 0.10), with the majority of reinterventions in the percutaneous group occurring early because of residual leak or persistent hemolysis. After risk adjustment, there was no significant difference in long-term survival between patients who underwent surgical versus transcatheter treatment of PVLs.

Conclusions

In contemporary practice, patients with symptomatic mitral PVLs are best treated with an integrated team approach incorporating both surgical and percutaneous techniques. Patient selection and timing of intervention are critical to achieve optimal results.





Rethinking Mitral Paravalvular Leak Closure: Surgical Approach or Plugging the Holes?




Surgery Versus Transcatheter Interventions for Significant Paravalvular Prosthetic Leaks
AbstractObjectives

This study sought to assess the relative merit of surgical correction (SC) versus transcatheter reduction on long-term outcomes in patients with significant paravalvular leak (PVL) refractory to medical therapy.

Background

PVL is the most frequent dysfunction following prosthetic valve replacement. Although repeat surgery is the gold standard, transcatheter reduction (TR) of PVL has been associated with reduced mortality.

Methods

From 1994 to 2014, 231 patients underwent SC (n = 151) or TR (n = 80) PVL correction. Propensity matching and Cox proportional hazards regression models were used to assess the effect of either intervention on long-term rates of all-cause death or hospitalization for heart failure. Survival after TR and SC were further compared with the survival in a matched general population and to matched patients undergoing their first surgical valve replacement.

Results

Over a median follow-up of 3.5 years, SC was associated with an important reduction in all-cause death or hospitalization for heart failure compared with TR (hazard ratio: 0.28; 95% confidence interval: 0.18 to 0.44; p < 0.001). There was a trend towards reduced all-cause death following SC versus TR (hazard ratio: 0.61; 95% confidence interval: 0.37 to 1.02; p = 0.06). Neither intervention normalized survival when compared with a general population or patients undergoing their first surgical valve replacement.

Conclusions

In patients with significant prosthetic PVL, surgery is associated with better long-term outcomes compared with transcatheter intervention, but results in important perioperative mortality and morbidity. Future studies are needed in the face of increasing implementation of transcatheter PVL interventions across the world.





Strategies for Paravalvular Prosthetic Leak Closure: Competing or Complementary?




Prosthetic Mitral Surgical Valve in Transcatheter Aortic Valve Replacement Recipients: A Multicenter Analysis
AbstractObjectives

The aim of this study was to determine the prognosis and specific complications of patients with prosthetic mitral valves (PMVs) undergoing transcatheter aortic valve replacement (TAVR).

Background

TAVR is performed relatively often in patients with PMVs, but specific risks are not well described.

Methods

A multicenter analysis was conducted, including patients with severe symptomatic aortic stenosis who underwent TAVR at 10 centers. Patients’ clinical characteristics and outcomes were evaluated according to the presence of a PMV.

Results

The mean age of the study population (n = 2,414) was 81 ± 8 years, and 48.8% were men. A total of 91 patients (3.77%) had PMVs. They were more commonly women, younger, and had higher surgical risk. PMVs were implanted a median of 14 years before TAVR, and most patients had mechanical prostheses (73.6%). Eighty-six patients (94.5%) were on long-term vitamin K inhibitor therapy, and bridging antithrombotic therapy was administered in 59 (64.8%). TAVR device embolization occurred in 6.7% (vs. 3.3% in the non-PMV group; p = 0.127), in all instances when distance between the PMV and the aortic annulus was <7 mm. Mortality rates did not show a difference, but the rate of bleeding was higher in patients with PMV (24.2% vs. 16.1%; p = 0.041), even in those treated via the transfemoral approach (22.2% vs. 13.9%; p = 0.048). Indeed, bleeding complications, prior atrial fibrillation, chronic obstructive pulmonary disease, surgical risk, and New York Heart Association functional class were independent predictors of mortality.

Conclusions

TAVR presents similar mortality irrespective of the presence of a PMV. However, patients with PMVs had higher bleeding risk that was independently associated with higher mortality. Risk for valve embolization was relatively high, but it occurred only in patients with PMV–to–aortic annulus distances <7 mm.





The International Multicenter TriValve Registry: Which Patients Are Undergoing Transcatheter Tricuspid Repair?
AbstractObjectives

This study sought to develop a large, international registry to evaluate the diffusion of these approaches and investigate patient characteristics and initial clinical results.

Background

Several transcatheter tricuspid valve therapies are emerging as therapeutic options for patients with severe symptomatic tricuspid regurgitation (TR), generally a high-risk surgical population.

Methods

The TriValve (Transcatheter Tricuspid Valve Therapies) registry included 106 high-risk patients (76 ± 9 years of age; 60.4% women; European System for Cardiac Operative Risk Evaluation II 7.6 ± 5.7%) from 11 cardiac centers, with severe TR.

Results

A total of 35% of the patients had prior left heart valve intervention (surgical in 29 of 106 and transcatheter in 8 of 106 patients). Right ventricular (RV) dysfunction (tricuspid annular plane systolic excursion <17 mm) was present in 56.3% of the patients; 95% of the patients were in New York Heart Association functional class III to IV. The etiology of TR was functional in 95.2%, and the mean tricuspid annulus was 45.4 ± 11 mm. In 76.9% of the patients, the main location of the regurgitant jet was central; pre-procedural systolic pulmonary artery pressure was 39.7 ± 13.8 mm Hg; and the inferior vena cava was severely dilated in most of the patients (27.4 ± 6.8 mm). Implanted devices included MitraClip (n = 58), Trialign (n = 17), TriCinch (n = 15), FORMA (n = 7), Cardioband (n = 5), and caval valve implantation (n = 3). One case had combined Trialign + MitraClip. Patients treated with the different techniques were similar in terms of European System for Cardiac Operative Risk Evaluation II and degree of RV dysfunction. In 68% of the cases the tricuspid intervention was performed as an isolated procedure. Procedural success was achieved in 62% of cases. At 30-day follow-up, all-cause mortality was 3.7%, with an overall incidence of major adverse cardiac and cerebrovascular events of 26%; 58% of the patients were New York Heart Association functional class I or II at 30 days.

Conclusions

Patients currently undergoing transcatheter tricuspid valve therapy are mostly high risk, with a functional etiology and very severe central regurgitation, and do not have severely impaired RV function. Initial results suggest that transcatheter tricuspid valve therapy is feasible with different techniques, but clinical efficacy requires further investigation.





Striding Forward on the Tricuspid Journey




Transcatheter Tricuspid Valve Repair With a New Transcatheter Coaptation System for the Treatment of Severe Tricuspid Regurgitation: 1-Year Clinical and Echocardiographic Results
AbstractObjectives

This study sought to describe the 1-year experience with the transcatheter FORMA system for severe tricuspid regurgitation (TR).

Background

Severe TR is associated with significant morbidity and mortality. Novel transcatheter therapies have been recently developed.

Methods

Eighteen patients underwent device implantation at 3 centers in Canada and Switzerland. Baseline characteristics, procedural, 30-day, and 1-year outcomes were prospectively evaluated using multimodality imaging and hemodynamic and clinical assessments.

Results

Procedural success was achieved in 16 (89%) patients. Unsuccessful procedures were because of right ventricular perforation requiring open surgery and device dislocation. At 1 year there were no deaths, significant arrhythmias, device infections, or dislocations. Thrombus was observed on 1 device at 4 months and there was 1 rehospitalization for heart failure. Among the 14 patients with successful device implantation and 1-year follow-up, 79% were in New York Heart Association functional class I/II (p < 0.001), the average 6-min walk test increased by 84 m (p = 0.03), and the Kansas City Cardiomyopathy Questionnaire heart failure score improved by 18 points (p = 0.02) compared with baseline. Echocardiography showed a reduction of TR from severe in 17 of 18 (94%) patients at baseline to moderate-severe or less in 11 of 16 patients (69%) by 30 days (p = 0.001) and 6 of 13 patients (46%) by 1 year (p = 0.01). The diameters of the tricuspid annulus and the right ventricle were reduced at 1 year (45.7 ± 4.8 mm to 42.1 ± 4.4 mm, p = 0.004; 54 ± 5.3 mm to 49.9 ± 4.3 mm, p = 0.02, respectively).

Conclusions

Implantation of the FORMA system in high-risk patients with severe TR shows feasibility with a good mid-term safety profile. At 1 year, despite variable success in reducing echocardiographic TR grade, there were significant clinical improvements and reductions in right ventricular dimensions.





A Step Forward for Transcatheter Tricuspid Valve Repair




Subacute Massive Pulmonary Thromboembolism: A Rare Delayed Complication After Radiofrequency Ablation




Delayed Left Main Coronary Artery Obstruction After Radiofrequency-Induced Coronary Dissection and Spasm: Insights From Optical Frequency-Domain Imaging and Intravascular Ultrasound Imaging




Mitral Valve-in-Ring Implantation With a Dedicated Transcatheter Mitral Valve Replacement System




Transcatheter Treatment of Severe Tricuspid Regurgitation Using the Edge-to-Edge Repair Technique in the Presence and Absence of Pacemaker Leads




Very Late Restenosis Following Bioresorbable Scaffold Implantation




Early Collapse of a Magnesium Bioresorbable Scaffold




Coronary Artery Aneurysm With Thrombosis After Implantation of a Bioresorbable Coronary Artery Scaffold




Clinical, Angiographic, and Procedural Correlates of Acute, Subacute, and Late Absorb Scaffold Thrombosis
AbstractObjectives

The authors sought to identify and verify independent correlates of device thrombosis from an analysis of multicenter trials and registries.

Background

Recent analyses suggest an increased risk of device thrombosis with Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, California) implantation compared with metallic drug-eluting stents, and data from moderate size studies suggest a risk relationship to vessel size and technique.

Methods

From 8,771 consecutively treated patients, 105 patients (1.2%) were identified with scaffold thrombosis within 1 year of implantation. They were matched 2:1 with controls selected randomly from nonthrombosis patients. Data-restricted multiple logistic analysis was used to identify significant independent covariates of the outcome.

Results

Early (within 1 month) scaffold thrombosis occurred in 69 patients and late (1 to 12 months) thrombosis occurred in 36 patients. Modelling found significant correlations of thrombosis to be final minimal lumen diameter <1.85 mm (odds ratio [OR]: 3.1; p = 0.004), off dual antiplatelet therapy (DAPT) status (OR: 3.1 to 3.5; p = 0.006 to 0.053), no post-dilatation with >1.1:1 balloon/scaffold ratio (OR: 2.3; p = 0.022), and reference vessel diameter <2.40 mm (OR: 2.1; p = 0.036).

Conclusions

Suboptimal vessel sizing, procedural technique, angiographic outcomes, and dual antiplatelet therapy discontinuation appear to be the principal determinants of Absorb scaffold thrombosis risk through 12 months after implantation.





Bioresorbable Vascular Scaffold Thrombosis: Solutions to the Problem?




Incidence, Clinical Presentation, and Predictors of Clinical Restenosis in Coronary Bioresorbable Scaffolds
AbstractObjectives

The aim of this study was to describe the incidence and clinical characteristics, including intracoronary imaging features, of clinical restenosis in bioresorbable coronary scaffolds (BRS). Further, the authors searched for clinical and procedural predictors of scaffold restenosis (ScR) and report on the clinical outcomes after treatment of ScR in a cohort of consecutive all-comer patients.

Background

Data from randomized controlled trials demonstrate a higher rate of target lesion failure in patients treated with BRS as compared with those treated with metal drug-eluting stents. Although in-scaffold thrombosis has been thoroughly investigated, there are little data available on the incidence and characteristics of ScR.

Methods

A total of 657 consecutive patients (age 63 ± 12 years, 79% men, 21% diabetics, 67% acute coronary syndrome) who received a total of 883 BRS for the treatment of coronary artery stenoses between May 2012 and January 2015 were enrolled in a retrospective registry.

Results

During the median follow-up of 1,076 days (interquartile range: 762 to 1,206 days), a total of 49 cases of ScR were found in 41 patients (Kaplan-Meier incidence: 2.4%, 6.0%, and 9.0% at 12-, 24-, and 36-month follow-up, respectively). ScR presented as stable angina or as incidental finding in 73% of the cases. The angiographic pattern was complex (type II to IV) in 55% of the ScR lesions. The neointima was homogeneous with high signal intensity in all but 3 cases at optical coherence tomography. Prior revascularization (hazard ratio [HR]: 2.7; 95% confidence interval [CI]: 1.5 to 5.1; p = 0.002), diabetes (HR: 2.9; 95%CI: 1.5 to 5.4; p = 0.001), lesion types B2 or C (HR: 2.8; 95% CI: 1.5 to 5.4; p = 0.002), and implantation technique (HR: 0.3; 95% CI: 0.1 to 0.6; p = 0.001) emerged as independent predictors of ScR. Oversizing (HR: 6.29; 95% CI: 2.4 to 16.4), undersizing (HR: 5.15; 95% CI: 1.99 to 13.30), and a residual stenosis >27% (HR: 8.9; 95% CI: 3.6 to 21.8) were associated with an increased ScR risk.

Conclusions

The 3-year incidence of ScR was similar to that observed in similar settings with newer-generation drug-eluting stents. It is often associated with a benign presentation and a complex angiographic pattern. Predictors of ScR match those of metallic stent restenosis, and the implantation technique used at index appears to play an important role.





Bioresorbable Vascular Scaffolds Restenosis: Pathophysiology and Predictors




6-Month Clinical and Angiographic Outcomes of a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold: The FANTOM II Study
AbstractObjectives

The purpose of this study was to evaluate the outcomes of the novel Fantom coronary bioresorbable scaffold at 6 months.

Background

The Fantom sirolimus-eluting bioresorbable scaffold incorporates a unique proprietary iodinated, polycarbonate copolymer of tyrosine analogs that is radiopaque, with thin struts (125 μm) that facilitate device delivery and precise target lesion treatment.

Methods

The 6-month outcomes and performance of the Fantom scaffold were evaluated in 117 patients with single de novo native coronary artery lesions of length ≤20 mm and reference vessel diameter 2.5 to 3.5 mm. The primary angiographic endpoint was mean late lumen loss at 6 months measured by quantitative coronary angiography. Procedural outcomes were categorized as short-term technical success, short-term procedural success, and clinical procedural success. The primary clinical endpoint was major adverse cardiac events at 6 months, the composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).

Results

Short-term technical success, short-term procedural success, and clinical procedural success were achieved in 96.6%, 99.1%, and 99.1% of patients, respectively. Mean 6-month in-stent late lumen loss was 0.25 ± 0.40 mm (n = 100). Binary restenosis was present in 2 patients (2.0%). Major adverse cardiac events within 6 months occurred in 3 patients (2.6%), including no deaths, 2 MIs, and 2 TLRs (1 patient had both an MI and TLR). Scaffold thrombosis occurred in 1 patient (0.9%).

Conclusions

The clinical results from 117 patients enrolled in cohort A of the multicenter FANTOM II (Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold) study demonstrate favorable 6-month outcomes of this novel device in the treatment of noncomplex coronary artery disease.





Fantom Bioresorbable Scaffold: Verse, But Not Yet Chorus (An Incomplete Composition)




Bioresorbable Vascular Scaffolds for Patients With In-Stent Restenosis: The RIBS VI Study
AbstractObjectives

This study sought to assess the value of bioresorbable vascular scaffolds (BVS) in patients with in-stent restenosis (ISR).

Background

Currently both drug-eluting stents (DES) and drug-eluting balloons (DEB) are recommended in patients with ISR. However, the value of BVS in this setting remains unclear.

Methods

RIBS VI (Restenosis Intra-stent: drug-eluting Balloon vs everolimus-eluting Stent) was a prospective multicenter study (19 Spanish sites) that included 141 patients treated with BVS for either bare-metal stent (BMS) ISR or DES-ISR. Late angiography was scheduled at 6 to 9 months. Inclusion/exclusion criteria were similar to those used in the RIBS IV (patients with DES-ISR) and RIBS V (patients with BMS-ISR) trials, where DEB (n = 249) was compared with everolimus (EES)-DES (n = 249). Results of BVS in RIBS VI were compared with those obtained with DEB and EES in the RIBS IV and V trials.

Results

On late angiography (n = 134; 95% of eligible) the in-segment minimal lumen diameter (primary endpoint) was 1.87 ± 0.5 mm, late lumen loss was 0.23 ± 0.4 mm, and restenosis rate was 11%. At 1-year follow-up (100% of patients) no patient died, 4 (2.8%) experienced a myocardial infarction, and 16 (11.3%) required target lesion revascularization. One patient (0.7%) who discontinued antiplatelet therapy experienced definitive BVS thrombosis. Freedom from cardiac death, myocardial infarction, and target lesion revascularization was 86%. The minimal lumen diameter at follow-up after BVS was similar to that obtained with DEB (1.88 ± 0.6 mm; p = NS) but smaller than that achieved after EES (2.16 ± 0.7 mm; p < 0.001). Likewise, target lesion revascularization rates after BVS were similar to those seen with DEB (10.4%) but higher than with EES (3.2%; p < 0.001). Results remained unchanged after adjusting for potential confounders in baseline characteristics.

Conclusions

This study suggests the safety and efficacy of BVS in patients with ISR. In this challenging anatomic scenario BVS obtained late angiographic and clinical results similar to DEB but inferior to EES. (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment [RIBS VI]; NCT02672878)





Bioabsorbable Stents: A Solution in Search of a Problem?




A Prospective Evaluation of a Pre-Specified Absorb BVS Implantation Strategy in ST-Segment Elevation Myocardial Infarction: The BVS STEMI STRATEGY-IT Study
AbstractObjectives

The aim of this study was to assess the feasibility and clinical results following a pre-specified bioresorbable scaffold (Absorb BVS) implantation strategy in patients with ST-segment elevation myocardial infarction (STEMI).

Background

Concerns were raised about the safety of Absorb because a non-negligible rate of thrombosis was reported within 30 days and at midterm follow-up after primary percutaneous coronary intervention.

Methods

This was a prospective, multicenter study of patients with STEMI (<75 years of age with symptom onset <12 h) undergoing primary percutaneous coronary intervention with Absorb following a dedicated implantation protocol. The primary endpoint was a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization within 30 days.

Results

During the study period, 505 patients with STEMI (16.9% of the overall STEMI population) were treated with the Absorb BVS. The mean age was 56.6 ± 9.4 years, and 487 patients (96.4%) were in Killip class I or II at admission. According to the study protocol, direct Absorb implantation was feasible in 47 patients (9.3%), whereas post-dilatation was performed in 468 cases (92.7%). Procedural success was attained in 94.8% of the cases. Dual antiplatelet therapy with ticagrelor or prasugrel was administered at discharge in 481 patients (95.1%). At 30-day follow-up, the hierarchical device-oriented composite endpoint rate was 0.6% (0.4% cardiac death, 0.2% target vessel myocardial infarction and ischemia-driven target lesion revascularization). One episode (0.2%) of probable scaffold thrombosis was reported.

Conclusions

A pre-specified Absorb implantation strategy in real-world patients with STEMI undergoing primary percutaneous coronary intervention was feasible and associated with a low 30-day device-oriented composite endpoint rate. Mid- and long-term follow-up is strongly needed to eventually confirm these early results. (Use of BVS in ST-Segment Elevation Myocardial Infarction [STEMI]: The BVS STEMI STRATEGY-IT Prospective Registry [STRATEGY-IT]; NCT02601781)





Bioresorbable Vascular Scaffold Implantation: To Whom and How?




Effect of Post-Dilatation Following Primary PCI With Everolimus-Eluting Bioresorbable Scaffold Versus Everolimus-Eluting Metallic Stent Implantation: An Angiographic and Optical Coherence Tomography TROFI II Substudy
AbstractObjectives

This study sought to investigate the effect of post-dilatation on angiographic and intracoronary imaging parameters in the setting of primary percutaneous coronary intervention comparing the everolimus-eluting bioresorbable scaffold (BRS) with the everolimus-eluting metallic stent (EES).

Background

Routine post-dilatation of BRS has been suggested to improve post-procedural angiographic and subsequent device-related clinical outcomes.

Methods

In the ABSORB STEMI TROFI II trial, 191 patients with ST-segment elevation myocardial infarction were randomly assigned to treatment with BRS (n = 95) or EES (n = 96). Minimal lumen area and healing score as assessed by optical coherence tomography at 6 months were compared between BRS- and EES-treated patients stratified according to post-dilatation status.

Results

Primary percutaneous coronary intervention with post-dilatation was performed in 48 (50.5%) BRS- and 25 (25.5%) EES-treated lesions. There were no differences in baseline characteristics and post-procedural minimal lumen diameter between groups. In the BRS group, lesions with post-dilatation were associated with a trend toward a smaller minimal lumen area at 6 months (5.07 ± 1.68 mm2 vs. 5.72 ± 1.77 mm2; p = 0.09) and significantly larger angiographic late lumen loss (0.28 ± 0.34 mm vs. 0.12 ± 0.25 mm; p = 0.02), whereas no difference was observed in the EES arm (5.46 ± 2.18 mm2 vs. 5.55 ± 1.77 mm2; p = 0.85). The neointimal healing score was low and comparable between groups with and without post-dilation (BRS: 1.55 ± 2.61 vs. 1.92 ± 2.17; p = 0.48; EES: 2.50 ± 3.33 vs. 2.90 ± 4.80; p = 0.72).

Conclusions

In the setting of selected patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with BRS or EES, post-dilatation did not translate into larger lumen area or improved arterial healing at follow-up. (ABSORB STEMI: The TROFI II; NCT01986803)





No TROFI for Routine Post-Dilatation After BVS Implantation




Efficacy and Safety of the Absorb Bioresorbable Vascular Scaffold in Females and Males: Results of an Individual Patient-Level Pooled Meta-Analysis of Randomized Controlled Trials
AbstractObjectives

Because females are under-represented in coronary trials, this study sought to assess the relative safety and efficacy of Absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California) and the Xience everolimus-eluting stent in females compared with males.

Background

The Absorb everolimus-eluting BVS provides drug delivery and mechanical support similar to a metallic drug-eluting stent, followed by resorption and restoration of more normal vascular structure with the potential to improve late clinical outcomes.

Methods

The ABSORB II, ABSORB III, ABSORB Japan, and ABSORB China trials were pooled. Baseline clinical, angiography, procedural variables, and 2-year outcomes were analyzed by sex and device.

Results

Among 3,384 randomized patients, 932 (27.5%) were female. Females were older, more often had diabetes and hypertension, but had less everolimus-eluting stent, 3-vessel disease, and smoking compared with males (all p≤0.001). The 2-year rates of target lesion failure with BVS versus everolimus-eluting stent in females were 8.9% versus 6.2% (study-level adjusted hazard ratio: 1.47; 95% confidence interval [CI]: 0.88 to 2.46) and 8.9% versus 6.4% in males (HR: 1.40; 95% CI: 1.02 to 1.92; pinteraction = 0.85). There were no significant interactions between sex and device type for any of the components of target lesion failure.

Conclusions

The relative treatment effects of BVS and everolimus-eluting stent for the 2-year rates of target lesion failure and other cardiovascular outcomes were consistent in females and males.





Bioresorbable Vascular Scaffolds in Women




Very Late Restenosis of a BVS Implanted in a Degenerated Saphenous Vein Graft




Neoatherosclerosis as the Cause of Late Failure of a Bioresorbable Vascular Scaffold at 8 Months




Is Transcatheter Aortic Valve Replacement Superior to Surgical Aortic Valve Replacement?: A Meta-Analysis of Randomized Controlled Trials




First Experience With the Coronary Sinus Reducer System for the Management of Refractory Angina in Patients Without Obstructive Coronary Artery Disease




Pardon the Interruption: An Interrupted Inferior Vena Cava Discovered During Attempted Implantation of a Left Atrial Appendage Occlusion Device




Percutaneous Closure of Left Ventricular Pseudoaneursym With Septal Occluder Device and Coils: A Multimodality Imaging Approach




Far From the Septum: Transcatheter Cardioform Septal Occluder Device Closure of a Descending Aortic Pseudoaneurysm Late After Interrupted Aortic Arch Repair




Reintervention Is Associated With Improved Survival in Pediatric Patients With Pulmonary Vein Stenosis
AbstractObjectives

The aim of this study was to evaluate survival following catheter intervention in pediatric patients with pulmonary vein stenosis (PVS).

Background

Despite aggressive surgical and catheter intervention on PVS in children, recurrence and progression of stenosis can lead to right heart failure and death. Clinicians continue to seek effective treatment options for PVS.

Methods

A single-center, retrospective study was performed including all patients <18 years of age who underwent catheter intervention (balloon angioplasty and bare-metal stent and drug-eluting stent insertion) on PVS. Endpoints included death, vein loss, and rate of reintervention.

Results

Thirty patients underwent intervention (balloon angioplasty, n = 9; bare-metal stent, n = 5; drug-eluting stent, n = 16) at a median age of 6.4 months (4.3 to 9.9 months). Median follow-up duration was 30.6 months (77 days to 10.5 years). Fourteen patients (47%) died at a median of 2.0 months (0.4 to 3.2 months) following intervention. There was no association between DES placement and survival (p = 0.067). Reintervention (catheter or surgical) was associated with improved survival (p = 0.001), with a 1-year survival rate of 84% compared with 25% for no reintervention. Vein loss occurred in 34 of 58 (59%) veins at a median of 3.3 months (1.0 to 5.0 months). One-year vein survival was higher with DES implantation (p = 0.031) and with reintervention (p < 0.001).

Conclusions

DES implantation at first catheter intervention appears to be associated with improved vein survival but may not result in improved patient survival. However, reintervention appears to be associated with improved patient survival and vein patency, suggesting that despite mode of treatment, frequent surveillance is important in the care of these patients.





Very Late Stent Migration Within a Giant Coronary Aneurysm in a Patient With Kawasaki Disease: Assessment With Multidetector Computed Tomography




Intraluminal Fibrous Webs in Brachial Artery Fibromuscular Dysplasia




The Effect of Strut Protrusion on Shear Stress Distribution: Hemodynamic Insights From a Prospective Clinical Trial




Early Initiation of Impella in Acute Myocardial Infarction Complicated by Cardiogenic Shock Improves Survival: A Meta-Analysis




Little Kids, Little Problems--Big Kids, Big Problems




Pre-Stenting and Melody Valve Stent Fracture: When More Is Less




Harmony Feasibility Trial: Acute and Short-Term Outcomes With a Self-Expanding Transcatheter Pulmonary Valve
AbstractObjectives

This study sought to obtain in vivo data to confirm assumptions on device loading conditions and assess procedural feasibility, safety, and valve performance.

Background

The Harmony transcatheter pulmonary valve (Medtronic, Minneapolis, Minnesota) was designed for patients with severe pulmonary regurgitation who require pulmonary valve replacement.

Methods

Three sites participated in this first Food and Drug Administration–approved early feasibility study using an innovative device design to accommodate the complex anatomy of the right ventricular outflow tract. Potentially eligible patients underwent review by a screening committee to determine implant eligibility. Six-month outcomes are reported.

Results

Between May 2013 and May 2015, 66 subjects were enrolled, and 21 were approved for implant and underwent catheterization; 20 were implanted. Catheterized patients had a median age of 25 years, were predominantly diagnosed with tetralogy of Fallot (95%), had severe pulmonary regurgitation (95%), and had trivial or mild stenosis. The device was delivered in the desired location in 19 of 20 (95%) patients. Proximal migration occurred in 1 patient during delivery system removal. Two devices were surgically explanted. Premature ventricular contractions related to the procedure were reported in 3 patients; 2 were resolved without treatment. One patient had ventricular arrhythmias that required treatment and later were resolved. At 1 month, echocardiography revealed none or trivial pulmonary regurgitation in all and a mean right ventricular outflow tract gradient of 16 ± 8 mm Hg (range 6 to 31 mm Hg).

Conclusions

In this feasibility study of the Harmony transcatheter pulmonary valve device, there was high procedural success and safety, and favorable acute device performance.





Stenting of the Right Ventricular Outflow Tract Promotes Better Pulmonary Arterial Growth Compared With Modified Blalock-Taussig Shunt Palliation in Tetralogy of Fallot-Type Lesions
AbstractObjectives

This study sought to compare pulmonary arterial (PA) growth during palliation after right ventricular outflow tract (RVOT) stenting versus modified Blalock-Taussig shunt (mBTS) in patients coming forward for complete repair of tetralogy of Fallot–type lesions.

Background

RVOT stenting is a recent alternative to mBTS in the initial palliation of selected patients with Fallot-type lesions.

Methods

This was a retrospective, single-center study of nonrandomized, consecutive palliated Fallot patients over a 10-year period. Differential left PA (LPA) and right PA (RPA) growth was assessed by serial echocardiograms in 67 patients after mBTS (n = 28) or RVOT stent (n = 39). Statistical data analysis was performed using mixed model analysis.

Results

RPA z-scores in the mBTS group improved from median –2.41 (interquartile range [IQR]: –2.97 to –1.32) to –1.13 (IQR: –1.68 to –0.59). LPA z-scores improved from –1.89 (IQR: –2.33 to –1.12) to –0.32 (IQR: –0.88 to –0.05). In the RVOT stenting group RPA z-scores improved from –2.28 (IQR: –3.28 to –1.82) to –0.72 (IQR: –1.27 to +0.48), and LPA z-scores from –2.08 (IQR: –2.90 to –0.61) to –0.05 (IQR: –0.88 to +0.48). Mixed model analysis showed significantly better RPA and LPA growth after RVOT stenting. The benefit of RVOT stenting versus mBTS was 0.599 z-scores for the LPA and 0.749 z-scores for the RPA. Rise in oxygen saturations was greater with RVOT stenting (p = 0.012). Median time to complete repair was shorter in the RVOT stent group (227 [142 to 328] days) compared with the mBTS group (439 [300 to 529] days; p < 0.0003).

Conclusions

RVOT stenting promotes better pulmonary arterial growth and oxygen saturations compared with mBTS in the initial palliation of Fallot-type lesions.





When Opportunity Knocks on the Front Door




Acute Success of Balloon Aortic Valvuloplasty in the Current Era: A National Cardiovascular Data Registry Study
AbstractObjectives

The aim of this study was to evaluate practice patterns and outcomes of a contemporary group of patients undergoing balloon aortic valvuloplasty (BAV) for congenital aortic stenosis (AS).

Background

BAV is the most common treatment for isolated congenital AS.

Methods

Within the IMPACT (Improving Pediatric and Adult Congenital Treatments) Registry, all BAV procedures performed between January 2011 and March 2015 were identified. Procedures were separated into those performed for critical versus noncritical AS. Outcomes were stratified into optimal, adequate, and inadequate, with optimal and adequate outcomes defining "successful" procedures. Multivariate logistic regression was used to identify patient and procedural characteristics associated with unsuccessful BAV. Mortality and adverse events rates were compared across patient cohorts.

Results

Of the 1,026 isolated BAV procedures captured in IMPACT, 718 (70%) were "successful." Success rates were 70.9% for noncritical AS (n = 916) and 62.7% for critical AS (n = 110). Multivariate analysis revealed that prior cardiac catheterization, mixed valve disease, baseline aortic valve gradient >60 mm Hg, baseline aortic insufficiency greater than mild, presence of a trainee, and multiple balloon inflations were associated with unsuccessful BAV in the noncritical AS cohort. There were no factors associated with unsuccessful procedures in the critical AS group. No procedural deaths occurred, but 2.4% of patients did not survive to hospital discharge. Adverse events occurred in 15.8% of all cases and were more frequent in procedures performed for critical AS (30.0% vs. 14.1%; p < 0.001).

Conclusions

BAV is an effective treatment for congenital AS with low rates of mortality and adverse events. Patients with critical AS have a higher risk for procedure-related adverse events.





The Impact of IMPACT--Contemporary Outcomes With Balloon Aortic Valvuloplasty: Are We Doing the Right Thing?




Transcatheter Occlusion of the Patent Ductus Arteriosus in 747 Infants <6 kg: Insights From the NCDR IMPACT Registry
AbstractObjectives

The authors sought to identify risk factors associated with major adverse events (MAEs) in infants <6 kg undergoing transcatheter patent ductus arteriosus (PDA) occlusion.

Background

Transcatheter PDA occlusion is among the safest of interventional cardiac procedures in adults and older children, but use among infants <6 kg has not been characterized adequately.

Methods

Using the IMPACT (IMproving Pediatric and Adult Congenital Treatments) registry, we identified infants <6 kg undergoing transcatheter PDA occlusion (January 1, 2011, to March 1, 2015). Using mixed-effects multivariate regression, the authors assessed characteristics predictive of MAE or composite failure (procedural failure or MAE). Individual safety metrics (e.g., embolization, malposition) were also examined for differences across weight thresholds: extremely low weight (LW) (<2 kg), very LW (2 to <4 kg), and LW (4 to <6 kg).

Results

Transcatheter PDA occlusion was attempted in 747 infants <6 kg at 73 hospitals. Rate of procedural success was 94.3%. MAEs were observed in 12.6% of cases; the most common events were acute arterial injury and device embolization in 3.5% and 2.4% of cases, respectively. Younger age (<30 days) was associated with greater risk of a MAE (risk ratio: 3.3; 95% confidence interval: 1.5 to 7.6) and composite failure (risk ratio: 3.0; 95% confidence interval: 1.4 to 6.7). Risk of embolization was higher among extremely LW (10.5%) than very LW or LW infants (1.6% and 2.5%, respectively; p = 0.050).

Conclusions

Among infants <6 kg, transcatheter PDA occlusion is technically feasible, but risks of MAE are noteworthy. These findings may help inform patient selection and procedural approach for transcatheter PDA occlusion and direct targeted research efforts to support the practice of evidence-based medicine.





Intervention on Surgical Systemic-to-Pulmonary Artery Shunts: Carotid Versus Femoral Access
AbstractObjectives

The purpose of this study was to compare results between the femoral arterial (FA) and carotid arterial (CA) approaches in catheter-based interventions on Blalock-Taussig shunts (BTS).

Background

Transcatheter intervention on BTS is often performed in shunt-dependent, hypoxemic infants. The approach to BTS intervention likely has an impact on timeliness and overall success.

Methods

The authors reviewed all cases of catheter intervention for BTS obstruction between 2012 and 2017 for their institution. They sought to compare procedural success rates and time, sheath time, time to arterial access, and time from access to stent implantation between FA and CA approaches.

Results

There were 42 BTS interventions between 34 patients. BTS intervention was more successful from the CA approach (p = 0.035). Among the FA cohort, BTS intervention was unsuccessful in 8 cases (25%), 5 of which were converted to CA with subsequent success. The CA cohort had lower procedure time (62 min vs. 104 min; p = 0.01) and anesthesia time (119 min vs. 151 min; p = 0.01). Additionally, CA access was associated with shorter time to arterial access (4.0 min vs. 9.3 min; p < 0.01), time to placement of the guidewire through the BTS (6.5 min vs. 13 min; p < 0.01), and time from the final sheath to BTS stent implantation (9 min vs. 20 min; p < 0.01).

Conclusions

Operators should consider the route of access to the BTS deliberately. The authors’ approach has been the carotid artery as an alternative access site—associated with greater procedural success, shorter procedural time, and shorter time to stent implantation.





New Approach to Intervention on Blalock-Taussig Shunts




Relationships Among Conduit Type, Pre-Stenting, and Outcomes in Patients Undergoing Transcatheter Pulmonary Valve Replacement in the Prospective North American and European Melody Valve Trials
AbstractObjectives

This study sought to evaluate the incidence of and risk factors for conduit and stent-related outcomes following transcatheter pulmonary valve replacement (TPVR).

Background

Stent fracture (SF) and right ventricular outflow tract (RVOT) reintervention are among the most important adverse outcomes after TPVR using the Melody valve (Medtronic, Minneapolis, Minnesota). The conduit environment and conduit preparation practices vary among patients who undergo TPVR.

Methods

Data from 3 prospective Melody valve multicenter studies were pooled and analyzed. All patients who had successful implant of a Melody valve that was present at hospital discharge comprised the study cohort; patients who had TPVR into a stentless conduit comprised the analysis cohort. SF was diagnosed using protocol-specified or clinical fluoroscopy or radiography, and classified as major or minor.

Results

Of 358 patients who underwent catheterization with intent to perform TPVR, 309 were discharged with the Melody valve in place (study cohort) of which 251 patients had TPVR into a stentless conduit (analysis cohort). Median follow-up was 5 years. New pre-stents were placed in 68% of patients with a stentless conduit, and 22% received multiple pre-stents. At 3 years, freedom from any SF and major SF was 74 ± 3% and 85 ± 2%, respectively, and freedom from RVOT reintervention was 85 ± 2%. New pre-stents were associated with longer freedom from SF and RVOT reintervention than was no pre-stent.

Conclusions

Risks of SF and reintervention after TPVR with a Melody valve were reduced by implantation of pre-stents, which has become standard practice. This study supports pre-stenting as an important component of TPVR therapy.





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