Post-infarction ventricular septal defect (PIVSD) is a mechanical complication of acute myocardial infarction (AMI) with a poor prognosis. Surgical repair is the mainstay of treatment, although ...percutaneous closure is increasingly undertaken.
Patients treated with surgical or percutaneous repair of PIVSD (2010-2021) were identified at 16 UK centres. Case note review was undertaken. The primary outcome was long-term mortality. Patient groups were allocated based upon initial management (percutaneous or surgical). Three-hundred sixty-two patients received 416 procedures (131 percutaneous, 231 surgery). 16.1% of percutaneous patients subsequently had surgery. 7.8% of surgical patients subsequently had percutaneous treatment. Times from AMI to treatment were similar percutaneous 9 (6-14) vs. surgical 9 (4-22) days, P = 0.18. Surgical patients were more likely to have cardiogenic shock (62.8% vs. 51.9%, P = 0.044). Percutaneous patients were substantially older 72 (64-77) vs. 67 (61-73) years, P < 0.001 and more likely to be discussed in a heart team setting. There was no difference in long-term mortality between patients (61.1% vs. 53.7%, P = 0.17). In-hospital mortality was lower in the surgical group (55.0% vs. 44.2%, P = 0.048) with no difference in mortality after hospital discharge (P = 0.65). Cardiogenic shock adjusted hazard ratio (aHR) 1.97 (95% confidence interval 1.37-2.84), P < 0.001), percutaneous approach aHR 1.44 (1.01-2.05), P = 0.042, and number of vessels with coronary artery disease aHR 1.22 (1.01-1.47), P = 0.043 were independently associated with long-term mortality.
Surgical and percutaneous repair are viable options for management of PIVSD. There was no difference in post-discharge long-term mortality between patients, although in-hospital mortality was lower for surgery.
Recent randomized controlled trials comparing femoral and radial access in primary percutaneous coronary intervention (PPCI) have shown conflicting results regarding the incidence of major adverse ...cardiovascular events (MACE) and major bleeding.
Using data from the HEAT-PPCI trial, we compared the primary efficacy (all-cause mortality, stroke, new myocardial infarction or unplanned repeat revascularization) and safety (major bleeding BARC 3–5) outcomes at 28 days, by final access site used (radial or femoral) and by default operator type. We then assessed outcomes in femoral cases performed by both operator types.
Radial access (RA) was associated with fewer MACE (91/1472 = 6.2% vs. 36/332 = 10.8% P = .003) and major bleeding events (38/1472 = 2.6% vs 22/332 = 6.6% P = .001) when compared to femoral access (FA). When analyzing outcomes by default operator type, there was a similar incidence of MACE (111/1575 = 7% vs 16/229 = 7% P = .97) and major bleeding events (49/1575 = 3.1% vs 11/229 = 4.8% P = .18). In cases where FA was performed by default radial operators, there was a higher rate of MACE (22/122 = 18% vs 14/210 = 6.7% P = .003) and major bleeding events (11/122 = 9% vs 11/210 = 5.2% P < .001), potentially explained by a higher risk profile in these cases.
Default femoral operators achieved comparable outcomes when compared to default radial operators. The less favorable outcomes observed in FA cases may result from its selective use by radial operators in high risk cases.
This study aimed to evaluate the safety and performance of the TriGuard™ Embolic Deflection Device (EDD), a nitinol mesh filter positioned in the aortic arch across all three major cerebral artery ...take-offs to deflect emboli away from the cerebral circulation, in patients undergoing transcatheter aortic valve replacement (TAVR).
The prospective, multicentre DEFLECT I study (NCT01448421) enrolled 37 consecutive subjects undergoing TAVR with the TriGuard EDD. Subjects underwent clinical and cognitive follow-up to 30 days; cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) was performed pre-procedure and at 4±2 days post procedure. The device performed as intended with successful cerebral coverage in 80% (28/35) of cases. The primary safety endpoint (in-hospital EDD device- or EDD procedure-related cardiovascular mortality, major stroke disability, life-threatening bleeding, distal embolisation, major vascular complications, or need for acute cardiac surgery) occurred in 8.1% of subjects (VARC-defined two life-threatening bleeds and one vascular complication). The presence of new cerebral ischaemic lesions on post-procedure DW-MRI (n=28) was similar to historical controls (82% vs. 76%, p=NS). However, an exploratory analysis found that per-patient total lesion volume was 34% lower than reported historical data (0.2 vs. 0.3 cm3), and 89% lower in patients with complete (n=17) versus incomplete (n=10) cerebral vessel coverage (0.05 vs. 0.45 cm3, p=0.016).
Use of the first-generation TriGuard EDD during TAVR is safe, and device performance was successful in 80% of cases during the highest embolic-risk portions of the TAVR procedure. The potential of the TriGuard EDD to reduce total cerebral ischaemic burden merits further randomised investigation.
Previous studies have demonstrated the feasibility of primary percutaneous coronary intervention (PPCI) in carefully selected nonagenarians. Although current guidelines recommend immediate ...revascularization in patients with ST elevation myocardial infarction (STEMI) it remains unclear whether PPCI reduces mortality in nonagenarians. The objective of this study is to compare mortality in nonagenarians presenting via the PPCI pathway who undergo coronary intervention, versus those who are managed medically.
A total of 111 consecutive nonagenarians who presented to our tertiary center via the PPCI pathway between July 2013 and December 2018 with myocardial infarction were included. Clinical and angiographic details were collected alongside data on all-cause mortality. The final diagnosis was STEMI in 98 (88.3%) and NSTEMI in 13 (11.7%). PPCI was performed in 42 (37.8%), while 69 (62.2%) were medically managed. A significant number of the medically managed cohort had atrial fibrillation (23.2% vs 2.4% p = 0.003) and presented with a completed infarct (43.5% vs 4.8% p = 0.001). Other baseline and clinical variables were well matched in both groups. There was a trend towards increased 30-day mortality in the medically managed group (40.6% vs 23.8% p = 0.07). Kaplan Meier survival analysis demonstrated a significant difference in survival by 3 years (48.1% vs 21.7% p = 0.01). This was the case even when those with completed infarcts were excluded (44.3% vs 14.6%, p = 0.01).
In this series of selected nonagenarians presenting with acute myocardial infarction, those undergoing PPCI appeared to have a lower mortality compared to those managed medically.
Diabetes mellitus (DM) is an important predictor of neointimal hyperplasia (NIH) and adverse clinical outcomes after percutaneous coronary intervention (PCI). LABR-312, a novel intravenous ...formulation of liposomal alendronate, has been shown in animal models to decrease NIH at vascular injury sites and around stent struts. The aim of the Biorest Liposomal Alendronate Administration for Diabetic Patients Undergoing Drug-Eluting Stent Percutaneous Coronary Intervention trial was to assess the safety, effectiveness, and dose response of LABR-312 administered intravenously at the time of PCI withDES in reducing NIH as measured by optical coherence tomography postprocedure in patients with DM.
Patients with DM were randomized to a bolus infusion of LABR-312 vs placebo at the time of PCI. Dose escalation of LABR-312 in the study arm was given: 0.01 mg, 0.03 mg, and 0.08 mg. The primary endpoint was the in-stent %NIH volume at 9 months as measured by optical coherence tomography.
From September 2016 to December 2017, 271 patients with DM undergoing PCI were enrolled; 136 patients were randomized to LABR-312 infusion and 135 patients were randomized to placebo. At 9-month follow-up, no difference was seen in the primary endpoint of %NIH between LABR-312 and placebo (13.3% ± 9.2 vs 14.6% ± 8.5, P = .35). No differences were present with the varying LABR-312 doses. Clinical outcomes at 9 months were similar between groups.
Among patients with DM undergoing PCI with drug-eluting stents, a bolus of LABR-312 injected systematically at the time of intervention did not result in a lower rate in-stent %NIH volume at 9-month follow-up.
Objectives
To evaluate solid embolization during transcatheter aortic valve implantation (TAVI) and correlate this with aortic valve calcification.
Background
There is a known stroke risk with TAVI, ...thought partly to be due to dislodgement of native aortic valve particles during implantation. However, to date there is little evidence that aortic valve calcification actually impacts embolic risk.
Methods
Transcranial Doppler (TCD) was performed on consecutive suitable patients undergoing TAVI, using hardware and software enabling differentiation between solid and gaseous emboli. Data was analyzed by time points during the TAVI procedure. These results were correlated with aortic valve calcification.
Results
TCD was successfully performed on 63 patients. The median number of solid emboli was 76.0. The most common time point for solid embolization was during valve positioning. Forty‐five of these patients had an appropriate CT scan which could be analyzed for an Agatston calcium score. The mean scores in the aortic valve and aortic root were 3382.4 and 754.9. There were significant correlations between the total number of solid emboli and valve calcium score (P = 0.033) and solid emboli during valve positioning and valve calcium score (P = 0.035). There was no relationship between gaseous emboli and valve calcium score.
Conclusions
TAVI is associated with significant solid particle embolization, with the most common time point being during valve positioning. Solid embolization correlates with aortic valve calcium score, suggesting that valve calcification is a factor in embolic risk. This should be taken into consideration along with other clinical factors when assessing embolic risk.
Objectives
To assess the necessity for balloon aortic valvuloplasty (BAV) during transfemoral transcatheter aortic valve implantation (TAVI) when using balloon‐expandable valves.
Background
BAV is a ...usual part of TAVI procedures, prior to valve implantation. However, the benefits and necessity of this are unknown and recent evidence in self‐expanding valves suggests it may not be necessary.
Methods
Retrospective single‐center study of 154 patients undergoing first‐time, transfemoral TAVI for native aortic valve stenosis, with (N = 76), and without (N = 78), BAV as part of the procedure. Data collected included demographic, procedural, and outcome data.
Results
BAV did not alter VARC‐2 defined procedural success or early safety compared to not performing a BAV, including mortality, degree of aortic regurgitation, or need for post‐TAVI balloon dilatation, although there was a strong trend to reduced stroke when not performing a BAV. There was a significantly reduced procedural time (P = 0.01) and fluoroscopic time (P < 0.001) without performing a BAV. There were no differences in cerebral embolization (solid, gaseous, or total emboli) noted between the 2 groups, as measured on transcranial doppler (TCD).
Conclusions
TAVI can be effectively and safely performed without a BAV and this results in reduced procedural and fluoroscopic times, although embolization to the brain is not reduced. There is a trend toward reduced stroke risk. (J Interven Cardiol 2016;29:319–324)
There was a reduction in total fluoroscopic time in Group 2 vs Group 1 (13.2 vs 17.3 mins, p=0.006), but no significant difference in total procedure time (112 vs 119 mins, p=0.21).There were no ...differences between the 2 groups in terms of number of solid, gaseous or total emboli on TCD (all p>0.05).
Despite rapid progress in device technologies for patent foramen ovale (PFO) closure over the past decade, long-tunnel anatomies still constitute a challenge. The present study investigated the ...performance of a novel in-tunnel device (Flatstent EF; Coherex Medical) in long-tunnel PFOs.
Three different umbrella devices (n = 61) and the Coherex Flatstent (n = 27) were used for PFO closure. The Flatstent was the preferred device in long-tunnel anatomies. Seven patients with long PFO tunnels underwent "detunnelization" by stepwise inflation of a low-pressure balloon followed by implantation of an umbrella device. Complete occlusion or trivial residual shunting ("clinical" occlusion) was achieved in 93% of the Flatstent and 92% of the umbrella device procedures (P=.92). Device performance in long-tunnel anatomies was in favor of the Flatstent (n = 24) compared with conventional occluders (n = 7), with "clinical" occlusion of 96% vs 86% (P=.24) and procedure time of 44 ± 16 minutes vs 59 ± 21 minutes (P=.04). Furthermore, postprocedural arrhythmias were significantly less frequent after Flatstent implantations (0.0% vs 9.1%; P=.03).
In long-tunnel PFOs, the Flatstent device was quicker to deploy, was at least as equally efficacious as umbrella devices, and reduced the incidence of symptomatic arrhythmias following PFO closure.
Persistent arterial hypertension (HT) has been associated with increased morbidity and mortality after surgical aortic valve replacement (AVR). The impact of increased blood pressure (BP) after ...transcatheter aortic valve implantation (TAVI) has not yet been fully elucidated.
The mean systolic and diastolic BP after TAVI were calculated from the last 10 non-invasive recordings performed before discharge in 176 patients. The primary end-point was symptomatic improvement after 6-12 months according to BP control at the time of discharge.
In patients with controlled BP (<140/90 mmHg), the symptomatic response after TAVI was significantly better compared to patients with uncontrolled BP (> or =140/90 mmHg), as reflected by NYHA functional class (+1.4 +/- 0.8 versus +0.8 +/- 1.0, p = 0.002) and six-minute walk test (6-MWT) distance improvement (+100 +/- 71 m versus +30 +/- 64 m, p < 0.001) at 6-12 months' follow up. A 10 mmHg decrease in systolic BP was associated with an 18 m increase in 6-MWT distance (p = 0.001). In addition, reverse left ventricular (LV) remodeling was significantly impaired in uncontrolled BP individuals, as reflected by regression of LV mass (-15 +/- 61 g versus -37 +/- 54 g, p = 0.041) and relative wall thickness (-0.02 +/- 0.09 versus -0.07 +/- 0.1, p = 0.01). Cumulative all-cause and cardiovascular mortality were significantly lower in patients with controlled BP compared to those with uncontrolled BP (6.5% versus 16%, p = 0.04; cardiovascular 3.7% versus 11.6%, p = 0.035).
Uncontrolled HT after TAVI may contribute to diminished symptomatic improvement.
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