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1.
Catheter Cardiovasc Interv ; 98(1): 170-175, 2021 07 01.
Article in English | MEDLINE | ID: mdl-33713533

ABSTRACT

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is maturing as a treatment option and is now often undertaken during an unscheduled index hospital admission. The aim of this study was to look at procedural and mid-term outcomes of patients undergoing elective versus urgent in-hospital transcatheter aortic valve implantation. METHODS: We identified a total of 1,157 patients who underwent TAVI between November 2007 and November 2019 at the Sussex Cardiac Centre in the UK. We compared the demographics, procedural outcomes, 30-day and 1-year mortality between elective and urgent patients. Emergency and salvage TAVI cases were excluded. RESULTS: Of the 1,157 patients who underwent the procedure, 975 (84.3%) had elective while 182 (15.7%) had urgent TAVI. Predominant aortic stenosis was more frequent in elective patients (91.7% vs. 77.4%); p < .01), while predominant aortic regurgitation was seen more commonly in the urgent group (11.5% vs. 4.2%; p < .01). Implantation success was similar between the elective (99.1%) and urgent group (99.4%). In-hospital (1.65% vs. 1.3%: p .11), 30 day (3.5% vs. 3.3%: p .81) and 1 year (10.9% vs. 11%; p .81) mortality rates were similar in the elective and urgent groups, respectively. CONCLUSIONS: In contemporary practice, urgent TAVI undertaken on the index admission can be performed at similar risk to elective outpatient TAVI.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Hospitals , Humans , Risk Factors , Severity of Illness Index , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
2.
Catheter Cardiovasc Interv ; 98(7): 1300-1307, 2021 12 01.
Article in English | MEDLINE | ID: mdl-33283484

ABSTRACT

OBJECTIVE: Octogenarians are a high-risk group presenting for percutaneous coronary intervention (PCI). We aimed to create a 30-day mortality risk model for octogenarians presenting with both acute coronary syndrome (ACS) and chronic stable angina (CSA), using comprehensive mandatory UK data submissions to the UK National database. BACKGROUND: Octogenarians are a high-risk group presenting for percutaneous coronary intervention, and decisions on whether or not to undertake intervention in this cohort can be challenging. The increasing number of octogenarians in the general population means they represent an important high-risk subgroup of patients. METHODS: The data group consisted of 425,897 PCI procedures undertaken in the UK between 2008 and 2012 during which time there was comprehensive data linkage to mortality via the Office of National Statistics. Of these procedures, 44,221 (10.4%) were in patients aged ≥80. These comprised the model group. Logistic regression was used to create a predictive score which ultimately consisted of the following weightings: age 80-89 (n = 1); age > 90 (n = 2); unstable angina/non-ST-elevation myocardial infraction (NSTEMI) (n = 1); STEMI (n = 2); creatinine >200 mmol/L (n = 1); preprocedural ventilation (n = 1); left ventricular ejection fraction <30% (n = 1); cardiogenic shock (n = 2). Multiple imputation was used to account for missing data. RESULTS: The patient cohort was divided into a derivation (n = 22,072) and a validation dataset (n = 22,071). Receiver operating characteristic analyses were used to derive the area-under-the-curve to assess properties of the score. The scoring system generated an AUC 0.83, (95% CI 0.80-0.85) suggesting high sensitivity and specificity. Scores of 1-4 were associated with good survival but scores ≥5 were associated with an estimated likelihood of death within 30 days of ≥40%. CONCLUSIONS: This octogenarian risk score maybe a useful tool to determine the chance of a successful outcome in elderly patients presenting for PCI.


Subject(s)
Octogenarians , Percutaneous Coronary Intervention , Aged , Aged, 80 and over , Humans , Percutaneous Coronary Intervention/adverse effects , Risk Factors , Stroke Volume , Treatment Outcome , Ventricular Function, Left
3.
Catheter Cardiovasc Interv ; 97(4): E552-E559, 2021 03.
Article in English | MEDLINE | ID: mdl-32779877

ABSTRACT

OBJECTIVES: We sought to identify baseline demographics and procedural factors that might independently predict in-hospital stroke following transcatheter aortic valve implantation (TAVI). BACKGROUND: Stroke is a recognized, albeit infrequent, complication of TAVI. Established predictors of procedure-related in-hospital stroke; however, remain poorly defined. METHODS: We conducted an observational cohort analysis of the multicenter UK TAVI registry. The primary outcome measure was the incidence of in-hospital stroke. RESULTS: A total of 8,652 TAVI procedures were performed from 2007 to 2015. There were 205 in-hospital strokes reported by participating centers equivalent to an overall stroke incidence of 2.4%. Univariate analysis showed that the implantation of balloon-expandable valves caused significantly fewer strokes (balloon-expandable 96/4,613 [2.08%] vs. self-expandable 95/3,272 [2.90%]; p = .020). After multivariable analysis, prior cerebrovascular disease (CVD) (odds ratio [OR] 1.51, 95% confidence interval [CI 1.05-2.17]; p = .03), advanced age at time of operation (OR 1.02 [0.10-1.04]; p = .05), bailout coronary stenting (OR 5.94 [2.03-17.39]; p = .008), and earlier year of procedure (OR 0.93 [0.87-1.00]; p = .04) were associated with an increased in-hospital stroke risk. There was a reduced stroke risk in those who had prior cardiac surgery (OR 0.62 [0.41-0.93]; p = .01) and a first-generation balloon-expandable valve implanted (OR 0.72 [0.53-0.97]; p = .03). In-hospital stroke significantly increased 30-day (OR 5.22 [3.49-7.81]; p < .001) and 1-year mortality (OR 3.21 [2.15-4.78]; p < .001). CONCLUSIONS: In-hospital stroke after TAVI is associated with substantially increased early and late mortality. Factors independently associated with in-hospital stroke were previous CVD, advanced age, no prior cardiac surgery, and deployment of a predominantly first-generation self-expandable transcatheter heart valve.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Stroke , Transcatheter Aortic Valve Replacement , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Cohort Studies , Hospitals , Humans , Stroke/epidemiology , Stroke/etiology , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome , United Kingdom/epidemiology
4.
Catheter Cardiovasc Interv ; 98(3): E444-E452, 2021 09.
Article in English | MEDLINE | ID: mdl-33502784

ABSTRACT

OBJECTIVES: To determine whether a permanent pacemaker (PPM) in situ can enhance survival after transcatheter aortic valve implantation (TAVI), in a predominantly inoperable or high risk cohort. BACKGROUND: New conduction disturbances are the most frequent complication of TAVI, often necessitating PPM implantation before hospital discharge. METHODS: We performed an observational cohort analysis of the UK TAVI registry (2007-2015). Primary and secondary endpoints were 30-day post-discharge all-cause mortality and long-term survival, respectively. RESULTS: Of 8,651 procedures, 6,815 complete datasets were analyzed. A PPM at hospital discharge, irrespective of when implantation occurred (PPM 1.68% [22/1309] vs. no PPM 1.47% [81/5506], odds ratio [OR] 1.14, 95% confidence interval [CI] 0.71-1.84; p = .58), or a PPM implanted peri- or post-TAVI only (PPM 1.44% [11/763] vs. no PPM 1.47% [81/5506], OR 0.98 [0.51-1.85]; p = .95) did not significantly reduce the primary endpoint. Patients with a PPM at discharge were older, male, had right bundle branch block at baseline, were more likely to have received a first-generation self-expandable prosthesis and had experienced more peri- and post-procedural complications including bailout valve-in-valve rescue, bleeding and acute kidney injury. A Cox proportional hazards model demonstrated significantly reduced long-term survival in all those with a PPM, irrespective of implantation timing (hazard ratio [HR] 1.14 [1.02-1.26]; p = .019) and those receiving a PPM only at the time of TAVI (HR 1.15 [1.02-1.31]; p = .032). The reasons underlying this observation warrant further investigation. CONCLUSIONS: A PPM did not confer a survival advantage in the first 30 days after hospital discharge following TAVI.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Pacemaker, Artificial , Transcatheter Aortic Valve Replacement , Aftercare , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Humans , Male , Patient Discharge , Postoperative Complications , Retrospective Studies , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
5.
Lancet ; 393(10190): 2503-2510, 2019 06 22.
Article in English | MEDLINE | ID: mdl-31056295

ABSTRACT

BACKGROUND: New-generation drug-eluting stents (DES) have mostly been investigated in head-to-head non-inferiority trials against early-generation DES and have typically shown similar efficacy and superior safety. How the safety profile of new-generation DES compares with that of bare-metal stents (BMS) is less clear. METHODS: We did an individual patient data meta-analysis of randomised clinical trials to compare outcomes after implantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and a 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% CIs. This study is registered in PROSPERO, number CRD42017060520. FINDINGS: We obtained individual data for 26 616 patients in 20 randomised trials. Mean follow-up was 3·2 (SD 1·8) years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR 0·84, 95% CI 0·78-0·90, p<0·001) owing to a reduced risk of myocardial infarction (0·79, 0·71-0·88, p<0·001) and a possible slight but non-significant cardiac mortality benefit (0·89, 0·78-1·01, p=0·075). All-cause death was unaffected (HR with DES 0·96, 95% CI 0·88-1·05, p=0·358), but risk was lowered for definite stent thrombosis (0·63, 0·50-0·80, p<0·001) and target-vessel revascularisation (0·55, 0·50-0·60, p<0·001). We saw a time-dependent treatment effect, with DES being associated with lower risk of the primary outcome than BMS up to 1 year after placement. While the effect was maintained in the longer term, there was no further divergence from BMS after 1 year. INTERPRETATION: The performance of new-generation DES in the first year after implantation means that BMS should no longer be considered the gold standard for safety. Further development of DES technology should target improvements in clinical outcomes beyond 1 year. FUNDING: Bern University Hospital.


Subject(s)
Myocardial Infarction/surgery , Percutaneous Coronary Intervention/instrumentation , Stents/adverse effects , Aged , Aged, 80 and over , Drug-Eluting Stents/adverse effects , Equivalence Trials as Topic , Female , Humans , Male , Middle Aged , Myocardial Infarction/mortality , Odds Ratio , Percutaneous Coronary Intervention/mortality , Prosthesis Design , Randomized Controlled Trials as Topic , Risk Assessment , Treatment Outcome
6.
Catheter Cardiovasc Interv ; 96(3): 528-533, 2020 09 01.
Article in English | MEDLINE | ID: mdl-31714674

ABSTRACT

BACKGROUND: Coronary collaterals are often seen supplying retrograde flow to an acutely occluded arterial territory. Whether this early collateralization offers prognostic benefit is not well established. METHODS: We analyzed data from all patients presenting to our regional cardiac unit with acute ST-elevation myocardial infarction requiring immediate angiography (years 1999-2017). Data on all patients is entered prospectively into a bespoke tailored database prior to knowledge of patient outcome. Only patients with TIMI 0 or 1 flow in the infarct-related vessel were included in the analysis. In-hospital and long-term outcome were assessed according to the presence or absence of angiographically visible collateral flow prior to treatment of the occluded vessel. RESULTS: Two thousand five hundred and forty-two patients were included in the analysis. 76% of these (n = 1944) had TIMI 0/1 flow at angiography. Angiographically-visible collateralization was seen in 17% (n = 322) and was more commonly observed in the right coronary artery (64%) than in the left anterior descending (25%) or Cx (6%). Cardiogenic shock (10.8%) and use of an intra-aortic balloon pump (5.4%) were more frequent in patients without coronary collateralisation (p = .04 and p = .02, respectively). The presence of collaterals improved long term survival (95% CI 11.4-18.7 months; p < .01). CONCLUSION: One-sixth of patients with STEMI have angiographically visible collaterals to the infarcted territory. Patients without collaterals are more likely to present in cardiogenic shock. The presence of angiographically visible collaterals at the time of STEMI is associated with an improved long-term survival.


Subject(s)
Collateral Circulation , Coronary Angiography , Coronary Circulation , ST Elevation Myocardial Infarction/diagnostic imaging , Aged , Databases, Factual , Female , Humans , Male , Middle Aged , Percutaneous Coronary Intervention , Predictive Value of Tests , Risk Factors , ST Elevation Myocardial Infarction/mortality , ST Elevation Myocardial Infarction/physiopathology , ST Elevation Myocardial Infarction/therapy , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/mortality , Shock, Cardiogenic/physiopathology , Shock, Cardiogenic/therapy , Time Factors , Treatment Outcome
7.
Am Heart J ; 198: 46-54, 2018 04.
Article in English | MEDLINE | ID: mdl-29653648

ABSTRACT

AIMS: Access site choice for cases requiring rotational atherectomy (PCI-ROTA) is poorly defined. Using the British Cardiovascular Intervention Society PCI database, temporal changes and contemporary associates/outcomes of access site choice for PCI-ROTA were studied. METHODS AND RESULTS: Data were analysed from 11,444 PCI-ROTA procedures performed in England and Wales between 2007 and 2014. Multivariate logistic regression was used to identify predictors of access site choice and its association with outcomes. RESULTS: For PCI-ROTA, radial access increased from 19.6% in 2007 to 58.6% in 2014. Adoption of radial access was slower in females, those with prior CABG, and in patients with chronic occlusive (CTO) or left main disease. In 2013/14, the strongest predictors of femoral artery use were age (OR 1.02, [1.005-1.036], P = .008), CTO intervention (OR 1.95, [1.209-3.314], P = .006), and history of previous CABG (OR 1.68, [1.124-2.515], P = .010). Radial access was associated with reductions in overall length of stay, and increased rates of same-day discharge. Procedural success rates were similar although femoral access use was associated with increased access site complications (2.4 vs. 0.1%, P < .001). After adjustment for baseline differences, arterial complications (OR 15.6, P < .001), transfusion (OR 12.5, P = .023) and major bleeding OR 6.0, P < .001) remained more common with FA use. Adjusted mortality and MACE rates were similar in both groups. CONCLUSIONS: In contemporary practice, radial access for PCI-ROTA results in similar procedural success when compared to femoral access but is associated with shorter length of stay, and lower rates of vascular complication, major bleeding and transfusion.


Subject(s)
Atherectomy, Coronary/methods , Cardiac Catheterization/methods , Coronary Stenosis/surgery , Percutaneous Coronary Intervention/methods , Radial Artery , Aged , Atherectomy, Coronary/mortality , Cohort Studies , Coronary Angiography/methods , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/mortality , Databases, Factual , Female , Humans , Kaplan-Meier Estimate , Logistic Models , Male , Middle Aged , Multivariate Analysis , Percutaneous Coronary Intervention/mortality , Prognosis , Proportional Hazards Models , Retrospective Studies , Risk Assessment , Severity of Illness Index , Societies, Medical , Statistics, Nonparametric , Survival Analysis , Treatment Outcome , United Kingdom
8.
Catheter Cardiovasc Interv ; 89(3): 438-444, 2017 Feb 15.
Article in English | MEDLINE | ID: mdl-27315455

ABSTRACT

BACKGROUND: Redo surgery for degenerative bioprosthetic aortic valves is associated with significant morbidity and mortality. Report results of valve-in-valve therapy (ViV-TAVI) in failed supra-annular stentless Freedom Solo (FS) bioprostheses, which are the highest risk for coronary occlusion. METHODS: Six patients with FS valves (mean age 78.5 years, 50% males). Five had valvular restenosis (peak gradient 87.2 mm Hg, valve area 0.63 cm2 ), one had severe regurgitation (AR). Median time to failure was 7 years. RESULTS: Patients were high risk (mean STS/Logistic EuroScore 10.6 15.8, respectively). FS valves ranged from 21 to 25 mm. Successful ViV-TAVI was achieved in 4/6 patients (67%). Of the unsuccessful cases, (patient 1 and 2 of series) patient 1 underwent BAV with simultaneous aortography which revealed left main stem occlusion. The procedure was stopped and the patient went forward for repeat surgery. Patient 2 underwent successful ViV-TAVI with a 26-mm CoreValve with a guide catheter in the left main, but on removal coronary obstruction occurred, necessitating valve snaring into the aorta. Among the successful cases, (patients 3, 4, 5, 6) the TAVIs used were CoreValve Evolut R 23 mm (n = 3), and Lotus 23 mm (n = 1). In the successful cases the peak gradient fell from 83.0 to 38.3 mm Hg. No patient was left with >1+ AR. One patient had a stroke on Day 2, with full neurological recovery. Two patients underwent semi-elective pacing for LBBB and PR >280 ms. CONCLUSIONS: ViV-TAVI in stentless Freedom Solo valves is high risk. The risk of coronary occlusion is high. The smallest possible prosthesis (1:1 sizing) should be used, and strategies to protect the coronary vessels must be considered. © 2016 Wiley Periodicals, Inc.


Subject(s)
Aortic Valve Insufficiency/therapy , Aortic Valve Stenosis/therapy , Aortic Valve/surgery , Bioprosthesis , Cardiac Catheterization/instrumentation , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis , Prosthesis Failure , Aged , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve Insufficiency/diagnostic imaging , Aortic Valve Insufficiency/etiology , Aortic Valve Insufficiency/physiopathology , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/etiology , Aortic Valve Stenosis/physiopathology , Bundle-Branch Block/etiology , Bundle-Branch Block/therapy , Cardiac Catheterization/adverse effects , Cardiac Catheterization/methods , Cardiac Pacing, Artificial , Coronary Occlusion/etiology , England , Feasibility Studies , Female , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Humans , Male , Prosthesis Design , Retreatment , Risk Factors , Stroke/etiology , Time Factors , Treatment Outcome
9.
Catheter Cardiovasc Interv ; 89(4): 783-786, 2017 Mar 01.
Article in English | MEDLINE | ID: mdl-27726292

ABSTRACT

INTRODUCTION AND METHOD: Transcatheter aortic valve implantation (TAVI) and balloon aortic valvuloplasty (BAV) are now well established percutaneous procedures. These procedures almost always require bursts of rapid ventricular pacing to temporarily reduce cardiac output to facilitate the procedure, usually done via a temporary pacing wire inserted into the right ventricle. We describe a case series of 132 cases of TAVI and 76 BAV done using ventricular pacing via the left ventricular lead by simply connecting one electrode to the patient's skin and one electrode through the left ventricular (LV) wire. RESULTS: All of the 132 TAVI cases (a mixture of Edwards Sapien, Medtronic CoreValve and Boston Scientific Lotus) and 76 BAV were successfully performed using pacing through the LV wire. No BAV patients required temporary pacing wire (TPW) or permanent pacemaker (PPM) insertion. Of the TAVI patients, 6 (4.5%) required TPW during the procedure due to complete heart block to facilitate removal of the LV wire. 1 patient (0.8%) required a PPM urgently due to complete heart block and haemodynamic instability. Twenty eight Patients (21.2%) required PPM following TAVI, 9 of which were within the first 24 hr. Average time to pacemaker implantation was 3.7 days. CONCLUSION: Rapid ventricular pacing via the LV wire is a simple, safe and effective strategy for percutaneous aortic valve intervention and balloon aortic valvuloplasty. It eliminates the need for a temporary pacing wire with its attendant risks in the vast majority of cases. Furthermore, most pacemakers following TAVI are required late, after the first 24 hr period, by which time the TPW has already usually been removed. © 2016 Wiley Periodicals, Inc.


Subject(s)
Aortic Valve Stenosis/surgery , Balloon Valvuloplasty/methods , Heart Block/prevention & control , Heart Ventricles/physiopathology , Pacemaker, Artificial , Postoperative Complications/prevention & control , Transcatheter Aortic Valve Replacement/methods , Aged, 80 and over , Cardiac Output/physiology , Female , Heart Block/etiology , Heart Rate/physiology , Heart Valve Prosthesis , Humans , Intraoperative Period , Male , Postoperative Complications/etiology , Retrospective Studies , Treatment Outcome
10.
Catheter Cardiovasc Interv ; 89(6): 994-1002, 2017 May.
Article in English | MEDLINE | ID: mdl-27527508

ABSTRACT

BACKGROUND: Second-generation drug eluting stents (DES) may reduce costs and improve clinical outcomes compared to first-generation DES with improved cost-effectiveness when compared to bare metal stents (BMS). We aimed to conduct an economic evaluation of a cobalt-chromium everolimus eluting stent (Co-Cr EES) compared with BMS in percutaneous coronary intervention (PCI). OBJECTIVE: To conduct a cost-effectiveness analysis (CEA) of a cobalt-chromium everolimus eluting stent (Co-Cr EES) versus BMS in PCI. METHODS: A Markov state transition model with a 2-year time horizon was applied from a US Medicare setting with patients undergoing PCI with Co-Cr EES or BMS. Baseline characteristics, treatment effects, and safety measures were taken from a patient level meta-analysis of 5 RCTs (n = 4,896). The base-case analysis evaluated stent-related outcomes; a secondary analysis considered the broader set of outcomes reported in the meta-analysis. RESULTS: The base-case and secondary analyses reported an additional 0.018 and 0.013 quality-adjusted life years (QALYs) and cost savings of $236 and $288, respectively with Co-Cr EES versus BMS. Results were robust to sensitivity analyses and were most sensitive to the price of clopidogrel. In the probabilistic sensitivity analysis, Co-Cr EES was associated with a greater than 99% chance of being cost saving or cost effective (at a cost per QALY threshold of $50,000) versus BMS. CONCLUSIONS: Using data from a recent patient level meta-analysis and contemporary cost data, this analysis found that PCI with Co-Cr EES is more effective and less costly than PCI with BMS. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.


Subject(s)
Cardiovascular Agents/administration & dosage , Cardiovascular Agents/economics , Chromium Alloys/economics , Coronary Artery Disease/economics , Coronary Artery Disease/therapy , Drug-Eluting Stents/economics , Everolimus/administration & dosage , Everolimus/economics , Health Care Costs , Percutaneous Coronary Intervention/economics , Percutaneous Coronary Intervention/instrumentation , Aged , Cardiovascular Agents/adverse effects , Coronary Artery Disease/diagnostic imaging , Cost-Benefit Analysis , Drug Costs , Everolimus/adverse effects , Female , Humans , Male , Markov Chains , Medicare/economics , Models, Economic , Percutaneous Coronary Intervention/adverse effects , Prosthesis Design , Quality-Adjusted Life Years , Randomized Controlled Trials as Topic , Time Factors , Treatment Outcome , United States
11.
J Interv Cardiol ; 30(2): 114-123, 2017 Apr.
Article in English | MEDLINE | ID: mdl-27925308

ABSTRACT

OBJECTIVES: We performed a post hoc analysis of outcome in patients with, versus those without, calcified target lesions from the BASE ACS trial. BACKGROUND: The outcome of contemporary stent implantation in patients with calcified lesions presenting with acute coronary syndrome is unknown. METHODS: The BASE ACS trial randomized 827 patients (1:1) presenting with acute coronary syndrome to receive either titanium-nitride-oxide-coated stents or everolimus-eluting stents. Calcified lesions were defined as moderate or severe calcification in the vessel wall by coronary angiography. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction or ischemia-driven target lesion revascularization. Follow-up was planned at 12 months, and yearly thereafter for up to 7 years. RESULTS: Of 827 patients enrolled in the trial, 352 (42.6%) had calcified target lesions. Median follow-up was 5.0 years. The incidence of MACE was higher in patients with, versus those without, calcified target lesions (19.6% vs. 12.2%, respectively, P = 0.004). This was driven by more frequent cardiac death and non-fatal myocardial infarction events (P < 0.05, both). The rates of ischemia-driven target lesion revascularization were comparable (P > 0.05). MACE and the other endpoints were comparable between the 2 propensity-score matched subgroups (P > 0.05 for all). Hypertension and smaller vessel size independently predicted MACE in patients treated for calcified lesions. CONCLUSIONS: Patients presenting with acute coronary syndrome who were treated for calcified lesions had worse long-term clinical outcome, compared with those treated for non-calcified lesions, mainly due to more frequent safety events. In the propensity score-matched analysis, the outcome was comparable.


Subject(s)
Acute Coronary Syndrome/surgery , Percutaneous Coronary Intervention , Stents , Vascular Calcification/surgery , Acute Coronary Syndrome/complications , Acute Coronary Syndrome/mortality , Aged , Coronary Angiography , Female , Follow-Up Studies , Humans , Male , Middle Aged , Myocardial Infarction/epidemiology , Propensity Score , Stents/adverse effects , Time Factors , Titanium , Treatment Outcome , Vascular Calcification/complications , Vascular Calcification/diagnostic imaging
12.
Eur Heart J ; 37(24): 1923-8, 2016 Jun 21.
Article in English | MEDLINE | ID: mdl-27161619

ABSTRACT

AIMS: Randomized trials of coronary bifurcation stenting have shown better outcomes from a simple (provisional) strategy rather than a complex (planned two-stent) strategy in terms of short-term efficacy and safety. Here, we report the 5-year all-cause mortality based on pooled patient-level data from two large bifurcation coronary stenting trials with similar methodology: the Nordic Bifurcation Study (NORDIC I) and the British Bifurcation Coronary Study: old, new, and evolving strategies (BBC ONE). METHODS AND RESULTS: Both multicentre randomized trials compared simple (provisional T-stenting) vs. complex (culotte, crush, and T-stenting) techniques, using drug-eluting stents. We analysed all-cause death at 5 years. Data were collected from phone follow-up, hospital records, and national mortality tracking. Follow-up was complete for 890 out of 913 patients (97%). Both Simple and Complex groups were similar in terms of patient and lesion characteristics. Five-year mortality was lower among patients who underwent a simple strategy rather than a complex strategy [17 patients (3.8%) vs. 31 patients (7.0%); P = 0.04]. CONCLUSION: For coronary bifurcation lesions, a provisional single-stent approach appears to be associated with lower long-term mortality than a systematic dual stenting technique.


Subject(s)
Stents , Coronary Artery Disease , Humans , Time Factors , Treatment Outcome
13.
Scand Cardiovasc J ; 50(4): 218-23, 2016 Aug.
Article in English | MEDLINE | ID: mdl-27102382

ABSTRACT

OBJECTIVES: The BASE-ACS trial demonstrated non-inferiority of titanium-nitride-oxide-coated bioactive stents (BAS), versus everolimus-eluting stents (EES), for major adverse cardiac events (MACE) at 1- and 2-year follow-up, in patients with acute coronary syndrome (ACS). We presented the 4-year outcome of the BASE-ACS trial. DESIGN: We randomized 827 patients with ACS to receive either BAS (417) or EES (410). MACE was a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR) at 12-month follow-up. Analyses were performed by intention to treat. Follow-up was planned at 12 months, and yearly thereafter for 5 years. RESULTS: Four-year clinical follow-up was completed in 753 (91.1%) patients. At 4 years, BAS were non-inferior to EES for MACE (14.7% versus 17.8%, respectively; p = 0.24 for superiority; p = 0.001 for non-inferiority). Non-fatal MI was less frequent with BAS (5.0% versus 9.2%, respectively; p = 0.025). Cardiac death and ischemia-driven TLR were comparable (2.9% versus 3.5%, and 8.6% versus 9.2%; p = 0.62 and p = 0.80, respectively). Independent predictors of MACE were calcified lesions (HR 1.54, p = 0.021), the number of vessels treated (HR 1.53, p = 0.025), and reference vessel diameter (HR 0.54, p = 0.006). CONCLUSIONS: In patients presenting with ACS, BAS was associated with a clinical outcome non-inferior to EES at 4-year follow-up.


Subject(s)
Acute Coronary Syndrome , Coronary Restenosis , Everolimus/therapeutic use , Percutaneous Coronary Intervention , Titanium/therapeutic use , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/therapy , Aged , Antineoplastic Agents/therapeutic use , Coronary Angiography/methods , Coronary Restenosis/diagnosis , Coronary Restenosis/etiology , Coronary Restenosis/prevention & control , Drug-Eluting Stents , Female , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/instrumentation , Percutaneous Coronary Intervention/methods , Prosthesis Design , Treatment Outcome
14.
Catheter Cardiovasc Interv ; 86(7): 1271-7, 2015 Dec 01.
Article in English | MEDLINE | ID: mdl-26119601

ABSTRACT

BACKGROUND: Surgical risk scoring systems are poor at predicting outcome in patients undergoing transcatheter aortic valve implantation (TAVI). Frailty indices might more accurately predict outcome. AIMS: To examine multiple frailty indices as markers of performance to see whether they predict outcomes both in the shorter (30 days) and longer terms (5 years) in patients who have undergone TAVI. METHODS: Frailty indices (Mobility; Brighton Mobility Index, New York Heart Association (NYHA), Karnofsky Performance Index, Canadian Study Health Association (CSHA) clinical frailty scale, and Katz Index of Dependence) were assessed in 312 consecutive TAVI patients. Mortality tracking was obtained from the Office of National Statistics as of May 2014. RESULTS: Mean age was 81.2 ± 7.0 years; 53.2% were male. Mean Logistic EuroSCORE and STS were 17.4 ± 9.4 and 4.6 ± 2.8, respectively. Mean peak aortic valve gradient and aortic valve area were 79.1 ± 28.0 mm Hg and 0.72 ± 0.25 cm(2) , respectively. 30-day mortality was 4.8%; long-term mortality (maximum 5.8 years, mean 2.2 ± 1.5 years) was 25.3%. Both univariate and multivariate analyses confirmed poor mobility (defined as severe impairment of mobility secondary to musculoskeletal or neurological dysfunction (Euroscore II risk)), as the best predictor of adverse outcome over both the short-term (OR 4.03, 95% CI (1.36-11.96), P = 0.012 (30 days)) and longer term (OR 2.15, 95% CI (1.33-3.48), P = 0.002, (2.2 ± 1.5 years.)). CONCLUSION: Poor mobility predicts worse survival among patients undergoing TAVI, both in the shorter and longer terms. Our data suggest that mobility impairment, of either neurological or musculoskeletal etiology, is an appropriate screening measure when considering patients for TAVI.


Subject(s)
Aortic Valve Stenosis/therapy , Cardiac Catheterization/adverse effects , Frail Elderly , Heart Valve Prosthesis Implantation/adverse effects , Mobility Limitation , Adult , Aged , Aged, 80 and over , Aortic Valve/physiopathology , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Cardiac Catheterization/mortality , Databases, Factual , England , Female , Geriatric Assessment , Heart Valve Prosthesis Implantation/mortality , Humans , Kaplan-Meier Estimate , Karnofsky Performance Status , Logistic Models , Male , Middle Aged , Odds Ratio , Proportional Hazards Models , Risk Adjustment , Risk Factors , Time Factors , Treatment Outcome
15.
Heart Lung Circ ; 24(7): 682-5, 2015 Jul.
Article in English | MEDLINE | ID: mdl-25637250

ABSTRACT

OBJECTIVES: The transradial approach limits vascular complications in coronary interventions. The same may be true for transcatheter aortic valve implantation (TAVI). We present our experience using secondary transradial arterial access. METHODS: Secondary transradial arterial access has been our default strategy for TAVI since 2007. Procedural data is collected prospectively. We assessed procedural success and complications. RESULTS: Data from 282 patients aged 81±5.2 yrs was examined. Secondary arterial access was transradial (74%), femoral (24%) and none (2%). Secondary femoral access was reserved for failed radial access (3%), anatomical anomalies (4%), operator preference (7%), trial requirements (6%) or proctor preference (4%). The principal pathology was aortic stenosis (90.8%), aortic regurgitation (6.7%) or a combination (2.5%). CoreValve (91.4%), Edwards (7%) or Lotus valves (1.7%) were delivered via transfemoral (88.6%), direct aortic (5.3%), subclavian (3.9%) or transapical approaches (1.8%). Significant vascular complications occurred in 25 cases (9.4%), including surgical repair of a failed percutaneous closure device (n=16), ilio-femoral dissection (n=3), iliac perforations (n=3), plaque disruption (n=1) and false aneurysm (n=2), one of which was from the secondary femoral access site. There was no local vascular complication from the secondary radial site. CONCLUSIONS: The transradial secondary access route for TAVI is safe and effective. The transradial route may limit vascular access complications from secondary transfemoral access.


Subject(s)
Aortic Valve Stenosis/surgery , Radial Artery , Transcatheter Aortic Valve Replacement/methods , Aged , Aged, 80 and over , Aortic Valve , Female , Femoral Artery , Humans , Male , Retrospective Studies
16.
Catheter Cardiovasc Interv ; 81(2): 366-73, 2013 Feb.
Article in English | MEDLINE | ID: mdl-22730270

ABSTRACT

OBJECTIVES: We sought to characterize UK-wide balloon aortic valvuloplasty (BAV) experience in the TAVI era. BACKGROUND: BAV for acquired calcific aortic stenosis is in a phase of renaissance, largely due to the development of transcatheter aortic valve implantation (TAVI). METHODS: Data from 423 patients at 14 centers across the UK were analyzed. RESULTS: Patients were aged 80.9 ± 9.5 years; 52.5% were male. Mean logistic EuroScore was 27.3% ± 16.8%. Mean peak transaortic gradient fell from 62.0 ± 26.3 to 28.3 ± 16.2 mm Hg. Aortic valve area increased from 0.58 ± 0.19 to 0.80 ± 0.25 cm(2) echocardiographically. Procedural complication rate was 6.3%, comprising death (2.4%), blood transfusion ≥ 2 U (1.2%), cardiac tamponade (1.0%), stroke (1.0%), vascular surgical repair (1.0%), coronary embolism (0.5%), and permanent pacemaker (0.2%). Mortality was 13.8% at 30 days and 36.3% at 12 months. Subsequently, 18.3% of patients underwent TAVI and 7.0% sAVR, with improved survival compared to those who had no further intervention (logrank < 0.0001). Multivariate Cox proportional hazard analysis demonstrated that survival was adversely effected by the presence of coronary artery disease (HR 1.53, 95%CI 1.08-2.17, P = 0.018), poor LV function (HR 1.54, 95%CI 1.09-2.16, P = 0.014), and either urgent (HR 1.70, 95%CI 1.18-2.45; P = 0.004) or emergent presentation (HR 3.72, 95%CI 2.27-6.08; P < 0.0001). CONCLUSION: Balloon aortic valvuloplasty offers good immediate hemodynamic efficacy at an acceptable risk of major complications. Medium-term prognosis is poor in the absence of definitive therapy.


Subject(s)
Aortic Valve Stenosis/therapy , Balloon Valvuloplasty , Calcinosis/therapy , Cardiac Catheterization , Heart Valve Prosthesis Implantation/methods , Aged , Aged, 80 and over , Aortic Valve/pathology , Aortic Valve/physiopathology , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Balloon Valvuloplasty/adverse effects , Balloon Valvuloplasty/mortality , Calcinosis/diagnosis , Calcinosis/mortality , Calcinosis/physiopathology , Cardiac Catheterization/adverse effects , Cardiac Catheterization/mortality , Chi-Square Distribution , Female , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/mortality , Hemodynamics , Humans , Kaplan-Meier Estimate , Logistic Models , Male , Middle Aged , Multivariate Analysis , Proportional Hazards Models , Retrospective Studies , Risk Assessment , Risk Factors , Treatment Outcome , United Kingdom
17.
J Interv Cardiol ; 26(4): 372-7, 2013 Aug.
Article in English | MEDLINE | ID: mdl-23859277

ABSTRACT

INTRODUCTION: Percutaneous coronary intervention (PCI) has historically required cardiothoracic backup in the event of ischemic complications. However, many complications occurring during PCI can now be effectively treated at the time of the indexed procedure. Equally, ischemic complications, which occur following coronary artery bypass grafting (CABG), which were previously treated medically or with reoperation, may now also be effectively treated by acute PCI. AIMS AND METHODS: To identify the rate, cause, treatment, and outcomes of ischemic complications from PCI or isolated CABG procedures undertaken from January 2004 to January 2011 where there was immediate crossover from PCI to CABG or vice versa, and to determine from the indexed revascularization procedure, whether or not the ischemic complications were rectified by either CABG with respect to PCI or PCI with respect to CABG. RESULTS: Three hundred fifty-six PCI major ischemic complications were identified. Three hundred forty-seven (97.5%) were rectified percutaneously and 9 (2.5%) required emergency CABG. The commonest reason for emergency CABG was occlusive dissection (n=7). Of the 9 patients that underwent emergency CABG, 3 patients (33.3%) died. Forty CABG major ischemic complications were identified. Twenty-seven (67.5%) were treated medically. Thirteen (32.5%) underwent diagnostic angiography. The etiology of the ischemia was found in all cases. Consequently, 2 underwent reoperation, one was treated medically, and 10 underwent acute PCI. CONCLUSION: Acute coronary ischemia remains a small but significant complication of both PCI and CABG. Resolution of ischemia requires prompt diagnosis and early discussion between cardiothoracic surgeon and cardiac interventionalist to determine the safest and therefore most appropriate way to resolve the problem.


Subject(s)
Acute Coronary Syndrome/therapy , Angina, Stable/therapy , Coronary Artery Bypass , Myocardial Ischemia/therapy , Percutaneous Coronary Intervention , Adult , Coronary Artery Bypass/adverse effects , Emergency Medical Services , Humans , Myocardial Ischemia/etiology , Percutaneous Coronary Intervention/adverse effects , Reoperation
18.
J Thromb Thrombolysis ; 35(4): 494-500, 2013 May.
Article in English | MEDLINE | ID: mdl-23242973

ABSTRACT

Trans-catheter aortic valve implantation (TAVI) is now recognised as an effective way to treat patients with symptomatic aortic stenosis when open surgical repair is not feasible or considered too high risk. Retrograde trans-femoral TAVI (TF-TAVI) requires large bore vascular access (18-24F), and successful management of the access site is key to maintaining the minimally invasive nature of the procedure. This editorial reviews the current techniques available to facilitate percutaneous vascular closure and the common complications associated with vascular access.


Subject(s)
Aortic Valve Stenosis/surgery , Cardiac Catheterization , Endovascular Procedures , Heart Valve Prosthesis , Vascular Access Devices , Cardiac Catheterization/instrumentation , Cardiac Catheterization/methods , Endovascular Procedures/instrumentation , Endovascular Procedures/methods , Humans
19.
J Invasive Cardiol ; 35(1): E37-E45, 2023 01.
Article in English | MEDLINE | ID: mdl-36495540

ABSTRACT

INTRODUCTION: Right bundle-branch block (RBBB) is a strong predictor of the development of high-grade AV block (AVB) after TAVI. AIMS: To assess mortality, length-of-hospital stay, and cost in patients with RBBB undergoing TAVI according to whether or not they had preprocedural permanent pacemaker (PPM) implantation. METHODS AND RESULTS: A total of 121 patients with RBBB who underwent TAVI between 2009-2021 were included. A total of 41 patients (33.9%) received a prophylactic PPM by clinical preference and 45/80 patients (56%) received PPM after TAVI. Baseline characteristics were balanced. Mortality was similar at 5 years, with death in 17 patients (41.4%) in the prophylactic PPM group vs 27 (33.8%) in the no prophylactic PPM group (adjusted hazard ratio [HR], 1.27; 95% confidence interval [CI], 0.69-2.33; P=.44). Median survival for the prophylactic PPM (4.2 years), post TAVI PPM (4.5 years) and no pacemaker (4.7 years) groups was similar. Sixteen deaths (35.6%) occurred in those receiving PPM after TAVI and 11 deaths (31.4%) occurred in those not receiving PPM (HR, 0.95; 95% CI, 0.43-2.09; P=.90). Thirty-day all-cause mortality was similar. Compared with post-TAVI PPM, prophylactic PPM reduced hospital length of stay (4.3 ± 4.5 days vs 2.5 ± 1.6 days, respectively; P=.02). For the highest and lowest complication and comorbidity scores, prophylactic PPM resulted in cost savings of £297.32 (-2.9%) and excess cost of £423.89 (+5.6%), respectively. There were no major pacing-related complications. CONCLUSIONS: More than half of patients with RBBB undergoing TAVI require PPM shortly after their valve implant. A prophylactic pacing strategy is safe, reduces length of hospital stay, and is cost effective in the United Kingdom.


Subject(s)
Aortic Valve Stenosis , Atrioventricular Block , Pacemaker, Artificial , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/methods , Bundle-Branch Block/diagnosis , Bundle-Branch Block/etiology , Bundle-Branch Block/therapy , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/complications , Atrioventricular Block/therapy , Pacemaker, Artificial/adverse effects , Aortic Valve/surgery , Treatment Outcome , Cardiac Pacing, Artificial , Risk Factors
20.
Catheter Cardiovasc Interv ; 80(6): 973-7, 2012 Nov 15.
Article in English | MEDLINE | ID: mdl-23139225

ABSTRACT

INTRODUCTION: An optimal fluoroscopic working view projection (OP) with all three aortic sinuses aligned is crucial during trans-catheter aortic valve implantation (TAVI). The aim of this study was to identify simple reference projection angles, which would act as a starting point for the operator to help determine OP for patients undergoing TAVI. METHODS: During the period under consideration, 50 patients underwent TAVI. Procedural data and outcomes were collected prospectively on a dedicated database. Optimal angiographic deployment angles were achieved for all patients by starting in an anteroposterior caudal 15 degrees projection and then adjusting according to the initial image, with multiple small volume contrast injections undertaken to determine when all three aortic cusps were aligned (OP). RESULTS: OP angles for the 50 cases were plotted on a graph. After normality testing confirmed that all angles were normally distributed, regression analysis enabled a regression line to be calculated. The equation for the regression line was defined as cranial/caudal intercept -16.4 ± 1.5 (SE of the coefficient), P < 0.0001, slope of regression line LAO/RAO + 0.53 ± 0.1 (SE of the coefficient SE), P < 0.0001). CONCLUSIONS: As the regression line and its equation represents an acceptable estimate of the true relationship between Cranial/Caudal and LAO/RAO, to determine OP while remaining close to the regression line we suggest starting in LAO = 8.9, Caudal = -11.4 (which represent the mean values of these two variables), and then increasing the caudal angle by approximately 0.5 degrees for every increase of 1 degree of the LAO angle or decreasing the caudal angle by 0.53 degrees for every decrease of 1 degree in LAO until all three aortic sinuses are in line which represents OP.


Subject(s)
Aortic Valve/diagnostic imaging , Aortography , Cardiac Catheterization , Heart Valve Prosthesis Implantation/methods , Radiographic Image Interpretation, Computer-Assisted , Therapy, Computer-Assisted , Aged , Aged, 80 and over , Female , Fluoroscopy , Humans , Linear Models , Male , Predictive Value of Tests , Radiography, Interventional/methods , Retrospective Studies , Treatment Outcome
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