Journal: Circ Cardiovasc Interv

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Abstract

Sex-Related Differences in the Prevalence and Prognostic Value of the Academic Research Consortium for High Bleeding Risk Criteria.

Nardin M, Cao D, Mehran R, Chandiramani R, ... Sharma SK, Kini A
Background
Bleeding events after percutaneous coronary intervention are associated with substantial morbidity and mortality. Female patients undergoing percutaneous coronary intervention are often older and present with a higher burden of comorbidities, which in turn increases their risk of adverse events, including bleeding complications. The Academic Research Consortium (ARC) have proposed a list of clinical criteria to define high bleeding risk (HBR). Our aim was to evaluate the prevalence and predictive value of the ARC-HBR criteria according to sex in a contemporary cohort of patients undergoing percutaneous coronary intervention.
Methods
All consecutive patients receiving coronary stenting between 2014 and 2017 at a tertiary-care center were defined as HBR if they fulfilled at least 1 major or 2 minor ARC-HBR criteria. The primary bleeding end point was the composite of periprocedural in-hospital or postdischarge bleeding up to 1 year. Individual components of the primary bleeding end point, all-cause mortality, and myocardial infarction were also evaluated.
Results
Of the total 9623 patients, 6979 (72.5%) were male and 2644 (27.5%) female. The prevalence of HBR was significantly higher in females compared with males (56.5% versus 39.9%, P<0.001). With regard to the individual criteria, moderate/severe anemia and moderate chronic kidney disease were more common in females, while oral anticoagulation and mild anemia were more frequent among males. The presence of HBR was associated with an increased risk of bleeding in both females (10.0% versus 4.4%; hazard ratio, 2.57 [95% CI, 1.80-3.67]; P<0.001) and males (8.7% versus 2.9%; hazard ratio, 3.19 [95% CI, 2.50-4.08]; P<0.001)(pinteraction=0.344).The ARC-HBR criteria associated with the highest bleeding risk at 1 year were severe/end-stage chronic kidney disease and thrombocytopenia in females, and moderate/severe anemia in males.
Conclusions
In a real-world cohort of percutaneous coronary intervention patients, females were more often at HBR than males. The prognostic value of the ARC-HBR definition was consistent between female and male patients, despite sex-related differences in the prevalence and bleeding risk associated with individual ARC-HBR criteria.



Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS120010392; epub ahead of print
Nardin M, Cao D, Mehran R, Chandiramani R, ... Sharma SK, Kini A
Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS120010392; epub ahead of print | PMID: 34474588
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Abstract

Utility of Intracardiac Echocardiography in the Early Experience of Transcatheter Edge to Edge Tricuspid Valve Repair.

Eleid MF, Alkhouli M, Thaden JJ, Zahr F, ... Reeder GS, Rihal CS
Background
Tricuspid edge to edge repair (TEER) is a novel treatment for severe tricuspid regurgitation and is highly dependent on intraprocedural image quality. To date, transesophageal echocardiography (TEE) has been the primary imaging modality used to guide TEER. The role of intracardiac echocardiography (ICE) has not been assessed. The objective of this study was to describe the use and role of 2-dimensional ICE in the early experience of TEER.
Methods
Consecutive patients undergoing TEER (with or without concomitant mitral repair) with off-label use of MitraClip (Abbott, Santa Clara, CA) were included in the study. Utilization of 2-dimensional ICE in comparison with TEE imaging were collected in each procedure through retrospective review of the procedural reports and images.
Results
Of 42 TEER cases, ICE was used in 15 (36%) and concomitant mitral repair was performed in 37 (86%). ICE was increasingly used over time for TEER. ICE was able to visualize the tricuspid leaflets with high resolution and provided superior leaflet visualization to TEE in 40% of cases where it was used. Patients treated with ICE guidance tended to have a greater baseline severity of tricuspid regurgitation compared with patients treated with TEE guidance alone (8/15 [53%] massive or greater tricuspid regurgitation versus 6/27 [22%]; P=0.09). Degree of tricuspid regurgitation reduction was similar with TEE alone versus ICE plus TEE guidance (1.9±1.0 versus 2.1±1.1 grade reduction, P=0.28).
Conclusions
ICE was increasingly used in the early experience of TEER over time. ICE facilitates leaflet visualization for grasping and is a useful adjunct to TEE during TEER.



Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS121011118; epub ahead of print
Eleid MF, Alkhouli M, Thaden JJ, Zahr F, ... Reeder GS, Rihal CS
Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS121011118; epub ahead of print | PMID: 34474586
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Abstract

Long-Term Outcomes Following Drug-Eluting Balloons Versus Thin-Strut Drug-Eluting Stents for Treatment of In-Stent Restenosis (DEB-Dragon-Registry).

Wańha W, Bil J, Januszek R, Gilis-Malinowska N, ... Jaguszewski M, Wojakowski W
Background
Data regarding the use of percutaneous coronary intervention with drug-eluting balloons (DEB) versus thin-strut drug-eluting stents (thin-DES) for treating DES in-stent restenosis in everyday clinical practice is scarce. Our goal was to evaluate the efficacy and safety profile of DEB versus thin-DES in DES in-stent restenosis.
Methods
Consecutive patients with DES in-stent restenosis who underwent percutaneous coronary intervention between 2008 and 2019 entered the multicenter DEB-DRAGON Registry with a follow-up of 3 years. Patients who received DEB at the index procedure (n=557, 49.9%) were compared with those who received thin-DES (n=560, 50.1%).
Results
Analysis of the unmatched cohort revealed lower rates of target lesion revascularization (9.1% versus 13.6%; hazard ratio [HR], 0.58 [95% CI, 0.41-0.83], P=0.003), target vessel revascularization (11.8% versus 16.7%; HR, 0.62 [95% CI, 0.45-0.84], P=0.003) and device-oriented composite end point, defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction (12.7% versus 16.0%; HR, 0.69 [95% CI, 0.50-0.94], P=0.018) in the thin-DES group compared with the DEB group. The incidence of cardiac death, target vessel-myocardial infarction, and myocardial infarction were similar in both groups. However, after propensity score matching, there were no significant differences in target lesion revascularization (11.2% versus 11.2%; HR, 0.91 [95% CI, 0.55-1.51], P=0.707), target vessel revascularization (13.4% versus 14.2%; HR, 0.86 [95% CI, 0.55-1.36], P=0.523), and device-oriented composite end point (14.2% versus 14.2%; HR, 0.91 [95% CI, 0.58-1.42], P=0.667) between the thin-DES and DEB group, respectively.
Conclusions
This analysis of a real-life registry revealed similar long-term outcomes of thin-DES and DEB in DES in-stent restenosis regarding target lesion revascularization, myocardial infarction, cardiac death, and device-oriented composite end point.
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: NCT04415216.



Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS121010868; epub ahead of print
Wańha W, Bil J, Januszek R, Gilis-Malinowska N, ... Jaguszewski M, Wojakowski W
Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS121010868; epub ahead of print | PMID: 34474584
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Abstract

Bleeding and Subsequent Cardiovascular Events and Death in Atrial Fibrillation With Stable Coronary Artery Disease: Insights From the AFIRE Trial.

Kaikita K, Yasuda S, Akao M, Ako J, ... Ogawa H, AFIRE Investigators
Background
Early bleeding after percutaneous coronary intervention is associated with increased risk of death and myocardial infarction; however, the association between bleeding and subsequent major adverse cardiac and cerebrovascular events (MACCE) remains unclear in patients with atrial fibrillation and stable coronary artery disease. We thus aimed to investigate this association.
Methods
The AFIRE trial (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) was a multicenter, open-label trial conducted in Japan. This post hoc analysis included 2215 patients with atrial fibrillation and stable coronary artery disease treated with rivaroxaban or rivaroxaban plus an antiplatelet agent. MACCE was defined as a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause. The association of bleeding with subsequent MACCE risk was investigated using time-adjusted Cox multivariate analysis after adjusting for baseline characteristics and time from bleeding. Bleeding events were classified according to the International Society on Thrombosis and Haemostasis criteria.
Results
Among the 2215 patients, 386 (17.4%) had bleeding during follow-up, of whom 63 (16.3%) also experienced MACCE; MACCE incidence was higher in patients with bleeding than in those without (8.38% versus 4.20% per patient-year; hazard ratio, 2.01 [95% CI, 1.49-2.70]; P<0.001). The proportion of patients with both bleeding and MACCE (developed after bleeding) was 73.0% (46 of 63); 27.0% (17 of 63) experienced MACCE before bleeding. Time-adjusted Cox multivariate analysis revealed a temporal association between major bleeding and subsequent MACCE, with particularly high MACCE risks within 30 days after major bleeding (hazard ratio, 7.81 [95% CI, 4.20-14.54]).
Conclusions
In patients with atrial fibrillation and stable coronary artery disease, major bleeding was strongly associated with subsequent MACCE. Thus, it is important to prevent major bleeding to avoid cardiovascular events and death. Registration: URL: https://www.umin.ac.jp/ctr; Unique identifier: UMIN000016612. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02642419.



Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS120010476; epub ahead of print
Kaikita K, Yasuda S, Akao M, Ako J, ... Ogawa H, AFIRE Investigators
Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS120010476; epub ahead of print | PMID: 34474583
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Abstract

Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension.

Mahfoud F, Sievert H, Bertog S, Lauder L, ... Pathak A, Persu A
Background
Primary results of this prospective, open-label, multicenter trial suggested that alcohol-mediated renal denervation with perivascular injection of dehydrated alcohol using the Peregrine System Infusion Catheter safely reduces blood pressure (BP) in patients with resistant hypertension. To date, maintenance of the BP-lowering effect beyond 6 months using this novel technology has not been reported. This article describes the final, 12-month follow-up data on the safety and efficacy of alcohol-mediated renal denervation in these patients.
Methods
Forty-five patients with resistant hypertension on a stable regimen of on average 5.1±1.5 antihypertensive medications underwent successful bilateral renal denervation using the Peregrine Catheter with alcohol as the neurolytic agent (0.6 mL per renal artery). Apart from 2 vascular access pseudoaneurysms (both without sequelae), no major procedural complications occurred.
Results
At 12 months post-procedure, mean 24-hour ambulatory systolic and diastolic BP were reduced by 10 mm Hg (95% CI, -16 to -5) and 7 mm Hg (-10 to -3), respectively (P<0.001). Office systolic/diastolic BP was reduced by 20/10 mm Hg (-27, -13/-14, -6; <0.001). Compared with baseline, the number of antihypertensive medications was reduced in 21% of patients, while it was increased in 19%. From baseline to 12 months, serum creatinine, urea, cystatin C, and spot urine albumin levels remained unchanged. The change in estimated glomerular filtration rates (-3.9±10.3 mL/minute per 1.73 m2 [95% CI, -7.1 to -0.75]; P=0.02) was within the expected range. There were no cases of renal artery stenosis up to 12-month follow-up.
Conclusions
Catheter-based chemical renal denervation with dehydrated alcohol using the Peregrine Catheter seems to safely reduce BP at follow-up of up to 12 months. Further randomized and sham controlled studies are underway to further validate these findings.
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: NCT02570113.



Circ Cardiovasc Interv: 01 Sep 2021:CIRCINTERVENTIONS120010075; epub ahead of print
Mahfoud F, Sievert H, Bertog S, Lauder L, ... Pathak A, Persu A
Circ Cardiovasc Interv: 01 Sep 2021:CIRCINTERVENTIONS120010075; epub ahead of print | PMID: 34470501
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Abstract

Horizontal Aorta in Transcatheter Self-Expanding Valves: Insights From the HORSE International Multicentre Registry.

Gallo F, Gallone G, Kim WK, Reifart J, ... Colombo A, Giannini F
Background
An increased degree of aortic angulation (AA) represents a challenging feature for bioprosthesis positioning. Whether AA has an impact on procedural outcomes of contemporary self-expanding valves remains unsettled. The aim of this study was to evaluate the impact of AA on procedural outcomes of transcatheter aortic valve replacement with contemporary self-expanding valves.
Methods
The HORSE (Horizontal Aorta in Transcatheter Self-Expanding Valves) is an international, retrospective registry including 3862 consecutive patients undergoing transcatheter aortic valve replacement with either Evolut R/PRO (n=1959) or ACURATE neo (n=1903) devices. Patients undergoing Evolut R 34 mm implantation were excluded as no comparable prosthesis size for ACURATE neo is available. AA was evaluated with preprocedural computed tomography, and its impact on device success was evaluated.
Results
In the overall population, AA did not have any impact upon device success, also when adjusting for in-study outcome predictors (odds ratio for 1° increment, 0.99 [95% CI, 0.98-1.01], P=0.306). However, increased AA was associated with lower device success with use of the Evolut R/PRO valves (odds ratio, 0.97 [95% CI, 0.95-0.99]; P=0.004), but not the ACURATE neo valves (odds ratio, 1.00 [95% CI, 0.98-1.03], P=0.304). The best AA cutoff value predicting device success was 49° (47% of the study cohort). Among patients with AA≥49°, Evolut R/PRO valves were associated with lower device success as compared to the ACURATE neo valve (inverse probability weighting odds ratio, 0.62 [95% CI, 0.46-0.83]; P=0.002).
Conclusions
Horizontal aorta, as defined by an AA ≥49°, is a common feature among transcatheter aortic valve replacement candidates and predicts device failure of the Evolut R/PRO valves, but not of the ACURATE neo valve. AA may be an effect modifier of the association between self-expanding valve type and device success.



Circ Cardiovasc Interv: 29 Aug 2021:CIRCINTERVENTIONS121010641; epub ahead of print
Gallo F, Gallone G, Kim WK, Reifart J, ... Colombo A, Giannini F
Circ Cardiovasc Interv: 29 Aug 2021:CIRCINTERVENTIONS121010641; epub ahead of print | PMID: 34455799
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Abstract

Initial Experience With the PASCAL Ace Implant System for Treatment of Severe Tricuspid Regurgitation.

Aurich M, Volz MJ, Mereles D, Geis NA, ... Konstandin MH, Raake PW
Background
Percutaneous tricuspid valve leaflet repair is an emerging treatment option for severe tricuspid regurgitation (TR). Recent studies demonstrated the usefulness and feasibility of the lately introduced TriClip and PASCAL Transcatheter Valve Repair System. However, initial experiences regarding safety and efficacy of the novel transcatheter PASCAL Ace implant system have not yet been reported.
Methods
Sixteen patients with severe, massive, or torrential TR underwent tricuspid leaflet repair using the PASCAL Ace implant at our cardiology department. All patients suffered from symptomatic right-sided heart failure with New York Heart Association functional class III or IV. Clinical, laboratory, echocardiographic, and procedural data were assessed. The primary efficiency end point was postprocedural reduction in TR of at least 1 grade. Secondary end points were feasibility, safety, clinical outcome, and improvement of structural and functional right heart parameters obtained by echocardiography.
Results
Eleven procedures (69%) resulted in successful reduction of TR. In 4 patients, PASCAL Ace implantation was not successful and one patient did not achieve TR reduction despite PASCAL Ace implantation. One major bleeding related to the intervention occurred. Eight patients (73%) with successful TR reduction reported a significant improvement of New York Heart Association functional class 4 weeks after implantation (P=0.008). A significant reduction in right atrial volume from 84±41 mL/m2 to 69±36 mL/m2 (P=0.004) and right ventricular end-diastolic diameter from 50±7 mm to 47±8 mm (P=0.013) was observed; however, we did not see an improvement in right ventricular function directly after implantation.
Conclusions
Tricuspid valve leaflet repair using the transcatheter PASCAL Ace implant system has the potential to improve clinical status and right heart reverse remodeling in patients with severe TR.



Circ Cardiovasc Interv: 25 Aug 2021:CIRCINTERVENTIONS121010770; epub ahead of print
Aurich M, Volz MJ, Mereles D, Geis NA, ... Konstandin MH, Raake PW
Circ Cardiovasc Interv: 25 Aug 2021:CIRCINTERVENTIONS121010770; epub ahead of print | PMID: 34433291
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Abstract

Real-World Experience With the SAPIEN 3 Ultra Transcatheter Heart Valve: A Propensity-Matched Analysis From the United States.

Nazif TM, Cahill TJ, Daniels D, McCabe JM, ... Leon MB, George I
Background
Paravalvular regurgitation (PVR) after transcatheter aortic valve replacement is associated with adverse clinical outcomes. The SAPIEN 3 Ultra (Ultra) is a new generation balloon-expandable transcatheter heart valve with a modified external skirt that is designed to reduce PVR, but reports of clinical and echocardiographic outcomes are limited. The aim of this study was to compare short-term outcomes of patients undergoing transcatheter aortic valve replacement with the Ultra and the original SAPIEN 3 (S3) transcatheter heart valve in a large national registry.
Methods
Data from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was used to compare patients who underwent elective, transfemoral transcatheter aortic valve replacement with the Ultra or S3 transcatheter heart valve. Clinical and echocardiographic outcomes were analyzed in a propensity-matched cohort at discharge and 30 days.
Results
Patients who underwent transcatheter aortic valve replacement with Ultra (N=1324) from January 2019 to February 2020 were propensity score-matched with patients treated with S3 (N=32 982) during the same period, resulting in 1324 matched pairs. There was no difference in the rate of device success between patients treated with Ultra and S3 (97.1% versus 98.0%, P=0.11). At hospital discharge, PVR was significantly reduced with Ultra compared with S3, with mild PVR in 9.0% versus 13.9% and moderate or greater PVR in 0.1% versus 0.4% (overall P<0.01). At 30 days, there were no differences between Ultra and S3 recipients in the rates of all-cause mortality or stroke (1.8% versus 2.8%, P=0.10), major vascular complications (1.1% versus 1.0%, P=0.84), or permanent pacemaker implantation (6.4% versus 6.2%, P=0.81).
Conclusions
In this propensity-matched analysis from the Transcatheter Valve Therapy Registry, the Ultra transcatheter heart valve was associated with similar procedural and 30-day clinical outcomes, but reduced incidence of PVR, compared with S3. The clinical benefit of less PVR should be evaluated in longer-term studies.



Circ Cardiovasc Interv: 25 Aug 2021:CIRCINTERVENTIONS121010543; epub ahead of print
Nazif TM, Cahill TJ, Daniels D, McCabe JM, ... Leon MB, George I
Circ Cardiovasc Interv: 25 Aug 2021:CIRCINTERVENTIONS121010543; epub ahead of print | PMID: 34433290
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Abstract

Compared Outcomes of ST-Elevation Myocardial Infarction Patients with Multivessel Disease Treated with Primary Percutaneous Coronary Intervention and Preserved Fractional Flow Reserve of Non-Culprit Lesions Treated Conservatively and of Those with Low Fractional Flow Reserve Managed Invasively: Insights from the FLOWER MI trial.

Denormandie P, Simon T, Cayla G, Steg PG, ... Danchin N, Puymirat E
Background: In patients with ST-elevation myocardial infarction (STEMI) and multivessel disease, percutaneous coronary intervention (PCI) for non-culprit lesions guided by FFR is superior to treatment of the culprit lesion alone. Whether deferring non-culprit PCI is safe in this specific context is questionable. We aimed to assess clinical outcomes at one-year in STEMI patients with multivessel coronary artery disease and an FFR-guided strategy for non-culprit lesions, according to whether or not ≥1 PCI was performed.
Methods:
Outcomes were analyzed in patients of the randomized FLOWER MI (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) trial in whom, after successful primary PCI, non-culprit lesions were assessed using FFR. The primary outcome was a composite of all-cause death, non-fatal MI, and unplanned hospitalization with urgent revascularization at one year.
Results:
Among 1,171 patients enrolled in this study, 586 were assigned to the FFR-guided group: 388 (66%) of them had ≥1 PCI and 198 (34%) had no PCI. Mean FFR before decision (i.e., PCI or not) of non-culprit lesions were 0.75±0.10 and 0.88±0.06, respectively. During follow-up, a primary outcome event occurred in 16 of 388 patients (4.1%) in patients with PCI and in 16 of 198 patients (8.1%) in patients without PCI (adjusted hazard ratio, 0.42; 95% confidence interval, 0.20 to 0.88; P = 0.02). Conclusions: In patients with STEMI undergoing complete revascularization guided by FFR measurement, those with ≥1 PCI had lower event rates at 1 year, compared with patients with deferred PCI, suggesting that deferring lesions judged relevant by visual estimation but with FFR >0.80 may not be optimal in this context. Future randomized studies are needed to confirm this data.




Circ Cardiovasc Interv: 22 Aug 2021; epub ahead of print
Denormandie P, Simon T, Cayla G, Steg PG, ... Danchin N, Puymirat E
Circ Cardiovasc Interv: 22 Aug 2021; epub ahead of print | PMID: 34420366
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Abstract

Transcatheter Mitral Valve Implantation: Current Status and Future Perspectives.

Russo G, Gennari M, Gavazzoni M, Pedicino D, ... Taramasso M, Maisano F
Mitral transcatheter therapies represent the treatment of choice for all patients deemed unsuitable for cardiac surgery. So far, the largest clinical experience has been limited to percutaneous repair techniques. However, given the complexity and heterogeneity of mitral valve anatomy and pathology, transcatheter mitral valve implantation will widen the mitral valve therapies horizon, toward a patient-tailored approach. Current data about transcatheter mitral valve implantation is still limited and, although some data are promising, there are still some issues to be addressed. This review provides a comprehensive insight into the available devices and describes potential advantages and limitations of transcatheter mitral valve implantation.



Circ Cardiovasc Interv: 18 Aug 2021:CIRCINTERVENTIONS121010628; epub ahead of print
Russo G, Gennari M, Gavazzoni M, Pedicino D, ... Taramasso M, Maisano F
Circ Cardiovasc Interv: 18 Aug 2021:CIRCINTERVENTIONS121010628; epub ahead of print | PMID: 34407621
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Abstract

Exercise Hemodynamic Profiling Is Associated With Outcome in Patients Undergoing Percutaneous Mitral Valve Repair.

Rieth AJ, Kriechbaum SD, Richter MJ, Wenninger E, ... Liebetrau C, Walther C
Background
Percutaneous mitral valve repair (PMVR) in high-risk patients is currently controversial, especially in those with secondary mitral regurgitation (MR). Exercise pulmonary hemodynamics may help to unmask cardiac dysfunction as well as the dynamic impact of MR. The present study sought to explore the clinical impact of preprocedural exercise right heart catheterization (RHC) for the selection of patients who could most benefit from PMVR.
Methods
Sixty-eight patients with symptomatic primary and secondary MR and exercise RHC before PMVR were included in this retrospective analysis of the association of exercise RHC parameters with survival and improvement in New York Heart Association class within 12 months.
Results
Median patient age was 77 years (±8.5), 37% were female, and 81% presented with New York Heart Association class III. A total of 65% of the patients had left ventricular ejection fraction <55%. MR was severe in 49% and moderate-to-severe in 51%. Twenty-two patients (32%) died within the follow-up period of 19 months (interquartile range, 9-32); they had a lower rise (Δ) in the V-wave on pulmonary artery wedge pressure tracings. Patients with ΔV-wave ≥17 mm Hg had a reduced risk of death after PMVR (hazard ratio, 0.11 [95% CI, 0.04-0.33], P<0.001), independent of age, frailty index, and workload during RHC. A higher ΔV-wave was also associated with New York Heart Association improvement (odds ratio, 1.14 [95% CI, 1.07-1.24]; P<0.001), and 79% of patients with ∆V-wave ≥15 mm Hg were in New York Heart Association class I or II at follow-up (<15 mm Hg: 28%). These results were for the most part confirmed in the subgroup of patients with secondary MR (65%).
Conclusions
In our cohort of patients with indication for PMVR, preprocedural exercise RHC was able to identify patients with an unfavorable outcome. Further studies with larger patient numbers are warranted before this approach can be implemented in a structured diagnostic workup of patients under evaluation for PMVR.



Circ Cardiovasc Interv: 10 Aug 2021:CIRCINTERVENTIONS120010453; epub ahead of print
Rieth AJ, Kriechbaum SD, Richter MJ, Wenninger E, ... Liebetrau C, Walther C
Circ Cardiovasc Interv: 10 Aug 2021:CIRCINTERVENTIONS120010453; epub ahead of print | PMID: 34376055
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Abstract

Safety and Effectiveness of the SVELTE Fixed-Wire and Rapid Exchange Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions: Results of the OPTIMIZE Randomized Study.

Kereiakes DJ, Feldman RL, Ijsselmuiden AJJ, Saito S, ... Cutlip DE, Rao SV
Background
The SVELTE fixed-wire and rapid exchange bioresorbable-polymer sirolimus-eluting coronary stent systems (SVELTE sirolimus-eluting stent [SES]) are novel, low-profile devices designed to facilitate direct stenting, transradial access, and enhance procedural efficiencies.
Methods
Eligible subjects (N=1639) scheduled to undergo percutaneous coronary intervention for non-ST-segment-elevation myocardial infarction or stable coronary artery disease were randomly assigned (1:1) to treatment with either SVELTE SES or a control durable polymer everolimus-eluting coronary stent. The primary end point was 12-month target lesion failure and a noninferiority margin was specified as 3.58% with an expected event rate of 6.5%.
Results
Target lesion failure was observed in 10.3% of SVELTE SES and 9.5% of control everolimus-eluting stent subjects under intention to treat analysis (difference=0.8%; PNI=0.034). Clinically indicated target lesion revascularization and stent thrombosis were observed in 1.5% versus 1.9% (P=0.57) and 0.38% versus 0.51% (P=0.72) of SVELTE SES versus control everolimus-eluting stent-treated subjects, respectively. Protocol-defined target vessel myocardial infarction (9.4% versus 8.2%) was higher than anticipated and more frequent at sites that utilized troponin versus creatine kinase myocardial band assays.
Conclusion
The SVELTE SES did not meet the prespecified threshold for noninferiority. Unexpectedly, high rates of target vessel myocardial infarction in both treatment groups contributed to higher than expected rates of target lesion failure, effectively underpowering the study. No differences between the SVELTE SES and control everolimus-eluting stent were observed for primary clinical or angiographic end point events.
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03190473.



Circ Cardiovasc Interv: 05 Aug 2021:CIRCINTERVENTIONS121010609; epub ahead of print
Kereiakes DJ, Feldman RL, Ijsselmuiden AJJ, Saito S, ... Cutlip DE, Rao SV
Circ Cardiovasc Interv: 05 Aug 2021:CIRCINTERVENTIONS121010609; epub ahead of print | PMID: 34353122
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Abstract

Hypothermia for Reduction of Myocardial Reperfusion Injury in Acute Myocardial Infarction: Closing the Translational Gap.

El Farissi M, Keulards DCJ, Zelis JM, van \'t Veer M, ... Pijls NHJ, Otterspoor LC
Myocardial reperfusion injury-triggered by an inevitable inflammatory response after reperfusion-may undo a considerable part of the myocardial salvage achieved through timely percutaneous coronary intervention in patients with acute myocardial infarction. Because infarct size is strongly correlated to mortality and risk of heart failure, the importance of endeavors for cardioprotective therapies to attenuate myocardial reperfusion injury and decrease infarct size remains undisputed. Myocardial reperfusion injury is the result of several complex nonlinear phenomena, and for a therapy to be effective, it should act on multiple targets involved in this injury. In this regard, hypothermia remains a promising treatment despite a number of negative randomized controlled trials in humans with acute myocardial infarction so far. To turn the tide for hypothermia in patients with acute myocardial infarction, sophisticated solutions for important limitations of systemic hypothermia should continue to be developed. In this review, we provide a comprehensive overview of the pathophysiology and clinical expression of myocardial reperfusion injury and discuss the current status and possible future of hypothermia for cardioprotection in patients with acute myocardial infarction.



Circ Cardiovasc Interv: 30 Jul 2021; 14:e010326
El Farissi M, Keulards DCJ, Zelis JM, van 't Veer M, ... Pijls NHJ, Otterspoor LC
Circ Cardiovasc Interv: 30 Jul 2021; 14:e010326 | PMID: 34266310
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Abstract

Transcatheter Aortic Valve Replacement for Bicuspid Aortic Valve Stenosis: A Practical Operative Overview.

Tarantini G, Fabris T
The bicuspid aortic valve (BAV) represents a complex anatomic scenario for transcatheter aortic valve replacement (TAVR) because of its unique technical challenges. As TAVR is moving towards younger and lower-risk populations, the proportion of BAV patients undergoing TAVR is expected to rise. Initial experiences of TAVR with first-generation transcatheter heart valves in high surgical risk patients with BAV stenosis showed higher rates of device failure and periprocedural complications as compared to tricuspid anatomy. The subsequent advances in imaging techniques and understanding of BAV anatomy, new iterations of transcatheter heart valves, and growing operators\' experience yielded better outcomes. However, in the lack of randomized trials and rigorous evidence, the field of TAVR in BAV has been driven by empirical observations, with wide variability in transcatheter heart valve sizing and implantation techniques across different centers and operators. Thus, in this review article, we provide a fully illustrated overview of operative periprocedural steps for TAVR in BAV stenosis, though recognizing that it still remains anecdotal.



Circ Cardiovasc Interv: 29 Jun 2021; 14:e009827
Tarantini G, Fabris T
Circ Cardiovasc Interv: 29 Jun 2021; 14:e009827 | PMID: 34130478
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