How Transcatheter Aortic Valve Implantation (TAVI) Was Born: The Struggle for a New Invention.

This story is about the invention of transcatheter aortic valve implantation (TAVI), and the people who transformed it from a concept and primitive device to a breakthrough lifesaving treatment for hundreds of thousands of patients with aortic valve stenosis. It is an inspirational example of a new disruptive technology that began with an idea most dismissed. The story describes the ups and downs from idea, design, construction, animal testing, proof-of-concept, scientific publication hurdles, a patent, license agreement, cooperation with several companies, fighting in patent courts in Europe and USA and finally how multinational companies financially bypassed the inventor. It is also a story about the struggles and battles the inventor experienced when injected into a world of lawyers and patent fights. I hope my personal story and journey can provide an inspiration and word of caution for new inventors.

High-pressure balloon fracturing of small dysfunctional Mitroflow bioprostheses facilitates transcatheter aortic valve-in-valve implantation.

AIMS: Transcatheter valve-in-valve (VIV) implantation is usually discouraged in small surgical tissue valves. We report our first ten cases of fracturing small dysfunctional Mitroflow bioprostheses by high-pressure balloon dilatation to increase the internal diameter of the surgical valve before VIV (BF-VIV). METHODS AND RESULTS: BF-VIV was performed in 10 patients (mean age 84±4 years) with failing Mitroflow valves size 19 mm (n=3, threshold of fracture 15 atm) and 21 mm (n=7, threshold of fracture 13 atm). An Edwards SAPIEN 3 or XT 20 mm or 23 mm transcatheter valve was implanted inside the fractured Mitroflow bioprosthesis. The procedure improved aortic valve area (0.7±0.3 vs. 1.1±0.3 cm2, p=0.001), reduced peak aortic valve gradient (66±27 vs. 29±7 mmHg, p=0.002), resolved aortic regurgitation and improved patients' NYHA functional class (p=0.005). One patient had a minor stroke with complete resolution of symptoms and another patient required a pacemaker due to AV block. All patients were still alive at the end of follow-up (438±255 days). CONCLUSIONS: Initial experience with transcatheter BF-VIV suggests that this method is feasible and safe, and that it improves aortic valve haemodynamics and clinical functional capacity. BF-VIV is a promising alternative to repeat surgery in patients with small failing Mitroflow bioprostheses.

Prosthetic valve endocarditis after transcatheter aortic valve implantation-diagnostic and surgical considerations.

Prosthetic valve endocarditis (PVE) after transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) is a potential life threatening complication. Better understanding of the incidence, predictors, clinical presentation, diagnostic measures, complications and management of PVE may help improve TAVI long-term outcome. We report a case of TAVI-PVE in an 80-year-old high risk patient in whom SAVR was successfully performed. We have reviewed literature regarding TAVI-PVE.

Transcatheter aortic valve implantation in a young heart transplant recipient crossing the traditional boundaries.

Transcatheter aortic valve implantation (TAVI) is an established therapeutic alternative to surgical aortic valve replacement (SAVR) in high-risk or inoperable patients with symptomatic aortic valve stenosis. Hitherto, TAVI is not recommended in young and low-intermediate risk patients. However, TAVI may also serve as an alternative to SAVR in selected young patients, e.g., patients who have previously undergone multiple cardiac surgery procedures. We report a case of trans-femoral TAVI in a 25-year-old heart transplant (HTx) recipient with prior surgery for congenital heart disease.

Syncope in paced patients with sick sinus syndrome from the DANPACE trial: incidence, predictors and prognostic implication.

OBJECTIVES: Syncope is a cause of significant morbidity in sick sinus syndrome (SSS) which may not be resolved with permanent pacemaker therapy. We aimed to determine the incidence, predictors and prognostic implication of syncope in paced patients with SSS. METHODS: We studied 1415 patients (mean age 72.9 years, SD 11.1) with SSS who were randomised in the DANPACE study to either rate-responsive single chamber pacing (n=707) or rate-responsive dual chamber pacing (n=708). Main outcome measures were patient-reported syncope after pacemaker implantation and mortality. RESULTS: Mean follow-up was 5.4 years (SD 2.6). A total of 247 (17.5%) patients experienced syncope after pacemaker implantation (135 (19%) from the rate-responsive single chamber pacing group, and 112 (15.8%) from the rate-responsive dual chamber pacing group. Predictors of syncope post pacemaker implantation included: age 0-39 years (HR 2.9, 95% CI 1.4 to 6.3, p=0.01; reference range 60-79 years), age ≥80 years (HR 1.4, 95% CI 1.0 to 1.8, p=0.03), syncope prior to pacemaker implant (HR 1.8, 95% CI 1.4 to 2.3, p<0.001), previous myocardial infarction (HR 1.5, 95% CI 1.1 to 2.1, p=0.03), heart failure (HR 1.4, 95% CI 1.0 to 1.9, p=0.046), and high Charlson comorbidity index (HR 1.6, 95% CI 1.1 to 2.2, p=0.01). Patients who experienced syncope post pacemaker implant had higher mortality compared with patients who did not (adjusted HR 1.6, 95% CI 1.3 to 2.1, p<0.001). CONCLUSIONS: Syncope in paced patients with SSS is common, and is associated with higher mortality. The predictors identified in this study suggest a multifactorial aetiology of syncope.

Health economic evaluation of single-lead atrial pacing vs. dual-chamber pacing in sick sinus syndrome.

AIMS: The recent Danish Multicentre Randomized Trial on Single-Lead Atrial (AAIR) Pacing versus Dual-Chamber (DDDR) Pacing in Sick Sinus Syndrome (DANPACE) suggested DDDR pacing as standard care. However, previous findings supported the routine use of AAIR pacing. This study investigated the cost-effectiveness of DDDR pacing compared with AAIR pacing for sick sinus syndrome. METHODS AND RESULTS: A decision-analytical model based on patient-level data from three randomized trials was designed from the Danish healthcare system's perspective. The main outcomes were lifetime costs, quality-adjusted lifeyears (QALYs), and net monetary benefit. Quality-adjusted lifeyears were calculated by utilizing community-based preferences. Costs were calculated by utilizing the extensive data on resource consumption, from the DANPACE trial. Data were pooled and adjusted for baseline differences. Dual-chamber pacing was shown to be cost-effective in all the analyses using a willingness-to-pay (WTP) threshold of £20,000/QALY, and most analyses using a WTP of £30,000/QALY. When pooling the data and adjusting for baseline differences, Monte Carlo simulations revealed a 51-71% probability of DDDR pacing being cost-effective at a WTP of £20,000/QALY, and a 42-58% probability at a WTP of £30,000/QALY. Dual-chamber pacing was most likely to be cost-effective among elderly patients with comorbidity. The expected value of perfect information was low and initiation of additional publicly funded Danish trials was discouraged. CONCLUSION: Dual-chamber pacing is likely to be a cost-effective treatment for sick sinus syndrome patients.

System upgrade and its complications in patients with a single lead atrial pacemaker: data from the DANPACE trial.

AIMS: To investigate the indications for system upgrade with single lead atrial pacing (AAIR), complications associated with these re-interventions, and possible predictors for system upgrade among patients included in the Danish Multicenter Randomized Trial on AAIR vs. dual-chamber pacing (DDDR) in sick sinus syndrome (DANPACE). METHODS AND RESULTS: A total of 707 of 1415 patients were randomized to AAIR pacing. Mean follow-up was 5.5 ± 2.6 years. Information on indications for system upgrade and complications were collected by reviewing patient charts. Multiple logistic regression was used to estimate adjusted odds ratios (aOR) with 95% confidence intervals (CI) for the association between predictors and system upgrade. Sixty-six patients (9.3%) in the AAIR group underwent system upgrade. Fifty-nine of these patients (89.3%) had a documented class I indication for system upgrade. Age (aOR 0.98 for each 1-year increase in age; 95% CI 0.6-1.0), and left atrial enlargement (aOR 1.9; 95% CI 1.0-3.8) were predictors for system upgrade. No single clinically applicable predictor for upgrade was identified. A total of 11 patients (16.7%) experienced at least one major complication after system upgrade. CONCLUSION: The majority of patients with AAIR pacing who underwent system upgrade had a class I indication. The incidence of major complications after system upgrade was high. The present data support the use of DDDR pacing rather than AAIR pacing in sick sinus syndrome.

CHADS2 and CHA2DS2-VASc score to assess risk of stroke and death in patients paced for sick sinus syndrome.

OBJECTIVE: The risk of stroke in patients with atrial fibrillation (AF) can be assessed by use of the CHADS2 and the CHA2DS2-VASc score system. We hypothesised that these risk scores and their individual components could also be applied to patients paced for sick sinus syndrome (SSS) to evaluate risk of stroke and death. DESIGN: Prospective cohort study. SETTINGS: All Danish pacemaker centres and selected centres in the UK and Canada. PATIENTS: Risk factors were recorded prior to pacemaker implantation in 1415 patients with SSS participating in the Danish Multicenter Randomized Trial on Single Lead Atrial Pacing versus Dual Chamber Pacing in Sick Sinus Syndrome (Danpace) trial. Development of stroke was assessed at follow-up visits and by evaluation of patient charts. Mortality was assessed from the civil registration system. INTERVENTIONS: Patients were randomised to AAIR (N = 707) or DDDR pacing (N = 708). MAIN OUTCOME MEASURES: Stroke and death during follow-up. RESULTS: Mean follow-up was 4.3 ± 2.5 years. In the AAIR group 6.9% patients developed stroke versus 6.1% in the DDDR group (NS). There was a significant association between CHADS2 score and the development of stroke (HR 1.41; 95% CI 1.22 to 1.64, p < 0.001). CHA2DS2-VASc score was also significantly associated with stroke (HR 1.25; CI 1.12 to 1.40, p < 0.001). CHADS2 score (HR 1.46; CI 1.36 to 1.56, p < 0.001) and CHA2DS2-VASc score (HR 1.39; CI 1.31 to 1.46, p < 0.001) were associated with mortality. Results were still significant after adjusting for AF and anticoagulation therapy. CONCLUSIONS: CHADS2 and CHA2DS2-VASc score are associated with increased risk of stroke and death in patients paced for SSS irrespective of the presence of AF.

Aortic regurgitation after transcatheter aortic valve implantation of the Edwards SAPIEN ™ valve.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is established as an attractive treatment option for high-risk patients with aortic valve stenosis. One concern is the high risk of prosthetic valve regurgitation. This study aimed to examine for potential preoperative risk factors for postprocedural transcatheter heart valve regurgitation and to quantify the risk, degree, and consequences of postprocedural regurgitation. MATERIALS AND METHODS: 100 consecutive patients who underwent femoral (n = 22) or transapical (n = 78) TAVI were retrospectively reviewed. Echocardiographic valve regurgitation and clinical parameters were analyzed over the first year after TAVI. RESULTS: Seventy-five percent of all patients had prosthetic valve regurgitation. It was, however, only mild or absent in 64% of patients and did not require re-intervention in any of the patients in the series. The severity of the regurgitation appeared unchanged over the one-year follow-up period. Moderate to severe regurgitation was associated with significant yet stable dilatation of the left ventricle over one year and lesser NYHA class improvement three months after TAVI. Asymmetrical native valve calcification increased the risk of paravalvular regurgitation non-significantly. CONCLUSION: Transcatheter heart valve regurgitation seems to be mild in the majority of cases and unchanged over a 12 months follow-up period. While affecting left ventricular dimensions in moderate or severe cases, we observed no obvious undesirable consequences of the prosthetic valve regurgitation within the first year.

Single center experience with transcatheter aortic valve implantation using the Edwards SAPIEN™ Valve.

OBJECTIVES: The use of transcatheter aortic valve implantation (TAVI) for high-risk patients was introduced in the early 2000s for treatment of aortic valve stenosis patients with too high surgical risk. During the last years, there has been a dramatic increase in TAVI procedures. TAVI programs are implemented in numerous cardiac centers. This paper describes a single center experience with its first 100 TAVI procedures. METHODS: This study included the first 100 patients who were scheduled for either transfemoral (F-TAVI) or transapical (A-TAVI) aortic valve implantation at Aarhus University Hospital, Skejby, using the Edwards SAPIEN™ valve. The indication for TAVI was unacceptable high predicted risk associated with conventional surgery. Patients with adequate diameter of iliac arteries were scheduled for F-TAVI, otherwise A-TAVI was preferred. RESULTS: The patients were treated between February 2006 and June 2010. Of these were 44% males and 56% females with a mean (S.D.) age of 81 (7.0). Thirty-days mortality rate was 8%, and decreased from 12% among the first 50 patients to 4% for the last 50 patients. Successful implantation was achieved in 92% patients. Major non-fatal complications were seen in 5% of 76 A-TAVI and in 0% of 24 F-TAVI patients. Mean (S.D.) EuroSCORE in the F-TAVI and A-TAVI groups was 15.9 (9.4) and 21.5 (14), respectively (p = 0.06). Post-procedural leakage of cardiac biomarkers was significantly higher in the A-TAVI group as compared to in the F-TAVI group. Mean (S.D.) NYHA class improved from 2.9 (0.6) to 1.8 (0.7) p < 0.001, with no significant difference between A-TAVI and F-TAVI patients. CONCLUSION: In surgically non-amenable patients, TAVI can be performed with acceptable mortality and morbidity and results in marked functional improvement. A decrease in 30-day mortality over time indicated a learning curve when implementing this treatment.

Prehospital troponin T testing in the diagnosis and triage of patients with suspected acute myocardial infarction.

Prehospital electrocardiographic (ECG) diagnosis has improved triage and outcome in patients with acute ST-elevation myocardial infarction. However, many patients with acute myocardial infarction (AMI) present with equivocal ECG patterns making prehospital ECG diagnosis difficult. We aimed to investigate the feasibility and ability of prehospital troponin T (TnT) testing to improve diagnosis in patients with chest pain transported by ambulance. From June 2008 through September 2009, patients from the central Denmark region with suspected AMI and transported by ambulance were eligible for prehospital TnT testing with a qualitative point-of-care test (cutpoint 0.10 ng/ml). Quantitative TnT was measured at hospital arrival and after 8 and 24 hours (cutpoint 0.03 ng/ml). A prehospital electrocardiogram was recorded in all patients. Prehospital TnT testing was attempted in 958 patients with a 97% success rate. In 258 patients, in-hospital TnT values were increased (≥0.03 ng/ml) during admission. The prehospital test identified 26% and the first in-hospital test detected 81% of patients with increased TnT measurements during admission. A diagnosis of AMI was established in 208 of 258 patients with increased TnT. The prehospital test identified 30% of these patients, whereas the first in-hospital test detected 79%. Median times from symptom onset to blood sampling were 83 minutes (46 to 167) for the prehospital sample and 165 minutes (110 to 276) for the admission sample. In conclusion, prehospital TnT testing is feasible with a high success rate. This study indicates that prehospital implementation of quantitative tests, with lower detection limits, could identify most patients with AMI irrespective of ECG changes.

Urban and rural implementation of pre-hospital diagnosis and direct referral for primary percutaneous coronary intervention in patients with acute ST-elevation myocardial infarction.

AIMS: Primary percutaneous coronary intervention (PCI) is the preferred treatment for ST-elevation myocardial infarction (STEMI). The distance to primary PCI centres and the inherent time delay in delivering primary PCI, however, limit widespread use of this treatment. This study aimed to evaluate the impact of pre-hospital diagnosis on time from emergency medical services contact to balloon inflation (system delay) in an unselected cohort of patients with STEMI recruited from a large geographical area comprising both urban and rural districts. METHODS AND RESULTS: From February 2004 until January 2007, data on pre-hospital timing and transport distance were prospectively recorded. Patients were divided into groups depending on achievement of pre-hospital diagnosis and/or direct referral to a primary PCI centre. Seven hundred and fifty-nine consecutive STEMI patients were included. In patients with a pre-hospital diagnosis and direct referral, the system delay was 92 vs. 153 min in patients without pre-hospital diagnosis (P < 0.001). Patients from rural areas were transported a median of 30 km longer than patients from urban areas; however, this prolonged the system delay by only 9 min. CONCLUSION: Pre-hospital electrocardiographic (ECG) diagnosis and direct referral for primary PCI enables STEMI patients living far from a PCI centre to achieve a system delay comparable with patients living in close vicinity of a PCI centre.

Time to treatment and three-year mortality after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction-a DANish Trial in Acute Myocardial Infarction-2 (DANAMI-2) substudy.

In patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention (pPCI), early reperfusion is believed to improve left ventricular systolic function and reduce mortality; however, long-term (>1 year) data are sparse. In the DANish Trial in Acute Myocardial Infarction-2 (DANAMI-2) study, 686 patients with ST-segment elevation myocardial infarction were treated with pPCI. Long-term mortality was obtained during 3 years of follow-up. We classified the patients according to the symptom-to-balloon time (<3, 3 to 5, and > or =5 hours). The groups were compared using a Cox proportional hazards regression model adjusted for confounding factors. The left ventricular systolic ejection fraction was estimated by echocardiography before discharge. Coronary flow was evaluated using the Thrombolysis In Myocardial Infarction score. Mortality did not differ between the 2 earliest symptom-to-balloon groups, and they were therefore combined into 1 group in the analysis of survival. Mortality was significantly increased for patients with a symptom-to-balloon time > or =5 hours (hazard ratio 2.36, 95% confidence interval 1.51 to 3.67, p <0.001), a difference that remained significant after controlling for confounding factors (adjusted hazard ratio 2.44, 95% confidence interval 1.31 to 4.54, p = 0.007). The symptom-to-balloon time was inversely associated with a left ventricular systolic ejection fraction of < or =40% (19.7% vs 22.8% vs 33.1%, p = 0.036), with the latter a major predictor of 3-year mortality in this cohort (hazard ratio 6.02, 95% confidence interval 3.68 to 9.85, p <0.001). A shorter symptom-to-balloon time was associated with greater rates of Thrombolysis In Myocardial Infarction 3 flow after pPCI (86.5% vs 80.9% vs 75.7%, p = 0.002). In conclusion, a shorter symptom-to-balloon time was associated with improved coronary flow, an increased likelihood of subsequent left ventricular systolic ejection fraction >40%, and greater 3-year survival in patients with ST-segment elevation myocardial infarction treated with pPCI.

[Catheter-based aortic valve substitution. Initial experiences with stent valve implantation]. / Kateterbaseret aortaklapsubstitution. Initiale erfaringer med implantation af stentklap.

INTRODUCTION: Recent years have seen the introduction of catheter-based aortic valve substitution with stent valves to treat aortic valve stenosis in patients who were deemed inoperable via conventional open heart surgery. We here report our initial experience. MATERIAL AND METHODS: Register-based study with prospective registration of prespecified parameters. A total of 26 patients were treated with an aortic stent valve, 12 via transfemoral (TFA-AVI) and 14 via transapical (TAP-AVI) access. In the TFA-AVI group, 75% were women and the average age was 85 4.5 years; in the TAP-AVI group, 71% were women and the average age was 79 8.4 years. RESULTS: In the TFA-AVI group, successful stent valve implantation was performed in 9/12 (75%) and TAP-AVI in 13/14 (93%) patients. Mortality after 30 days was 25% in the TFA-AVI and 7% in the TAP-AVI group. The aortic valve area increased from 0.6 0.13 cm(2) to 1.6 0.39 (2) in the TFA-AVI group and from 0.7 0.2 (2) to 1.6 0.37 (2) in the TAP-AVI group. 91% of patients showed clinical improvement after treatment. CONCLUSION: Transcatheter aortic valve implantation of conventional unresectable patients requires close cooperation between different specialities. The treatment seems to be a realistic alternative to medical treatment for inoperable patients and may even be used in operable high-risk patients.

History of percutaneous aortic valve prosthesis.

This review describes the development of percutaneous transluminal catheter-mounted heart valves for permanent implantation. The time period from the first surgically implanted valve in 1952, through catheter- mounted valves inserted for temporal relief, until the conception of the percutaneous transcatheter heart valve for permanent implantation is summarized. The process involved in the construction of the new valve is detailed in Figure 1, and the future of this new treatment modality is discussed.

Transapical transcatheter treatment of a stenosed aortic valve bioprosthesis using the Edwards SAPIEN Transcatheter Heart Valve.

Transcatheter transapical or transfemoral aortic valve replacement has emerged as an alternative therapy of severe, symptomatic valvular aortic stenosis in surgically nonamenable patients. We report a transapical treatment of a severely stenosed 21-mm aortic Mitroflow valve bioprosthesis (Sorin Group, Vancouver, British Columbia, Canada) in an 82-year-old woman using a 23-mm Edwards SAPIEN Transcatheter Heart Valve (Edwards Lifesciences, Irvine, CA).

ST changes before and during primary percutaneous coronary intervention predict final infarct size in patients with ST elevation myocardial infarction.

BACKGROUND: In patients with ST elevation myocardial infarction (STEMI), spontaneous ST resolution (spontSTR) is a marker of successful microvascular reperfusion. The significance of increase in ST elevation during reperfusion therapy (the ST peak phenomenon), however, is controversial. AIMS: The purpose of the study was to evaluate whether preprocedural and periprocedural ST changes predict final infarct size (IS) in STEMI patients treated with primary percutaneous coronary intervention (primary PCI). METHODS: Twelve-lead electrocardiograms (ECGs) were acquired in the prehospital phase and on admission in 200 STEMI patients transferred for primary PCI. Continuous ST monitoring was performed during and 90 minutes after primary PCI. The exact timing of interventional procedures and the resulting thrombolysis in myocardial infarction (TIMI) flow were registered. A 1-month single-photon emission computerized tomography was performed to evaluate IS. Patients were stratified into groups according to preprocedural and periprocedural ST changes as follows: patients with spontSTR before primary PCI and without (A) or with (B) ST peak during primary PCI and patients with persistent ST elevation before primary PCI and without (C) or with (D) ST peak during primary PCI. FINDINGS: Groups A (n = 45), B (n = 10), C (n = 109), and D (n = 36) differed with regard to IS (median, 2%, 3%, 13% vs 22% of the left ventricle; P < .0001). In multivariable analysis adjusting for baseline characteristics, preprocedural and periprocedural ECG findings and routine angiography findings, spontSTR was associated with smaller IS (B = -8.6%; P < .001), whereas the ST peak phenomenon was associated with larger IS (B = +5.0%; P = .006). There was no difference in TIMI flow grades in relation to coronary interventions among patients with and without ST peak during primary PCI. CONCLUSIONS: In STEMI patients, spontSTR before primary PCI and the ST peak phenomenon during primary PCI predict minor vs extensive IS independent of angiographic patency grades. Further studies are needed to clarify whether the ST peak phenomenon is "a marker of injury before reperfusion" or "a marker of reperfusion-induced injury."

[Telemedical pre-hospital diagnosis of a patient with thoracic aortic dissection]. / Telemedicinsk praehospital diagnostik og visitation af en patient med aortadissektion.

Thoracic aortic dissection is a life-threatening emergency that must be met and surmounted immediately to increase survival. In this case, telemedicine involving ECG and GSM-based communication between the patient in the ambulance and the centre doctor was used to obtain remote pre-hospital suspicion of aorta dissection. Thus, the ambulance was re-routed directly to a specialized unit where the diagnosis was confirmed and immediate and successful surgical treatment was performed. Telemedicine allowing direct communication between the patient and the doctor is recommended.

Long-term outcome of primary angioplasty compared with fibrinolysis across age groups: a Danish Multicenter Randomized Study on Fibrinolytic Therapy Versus Acute Coronary Angioplasty in Acute Myocardial Infarction (DANAMI-2) substudy.

BACKGROUND: Primary angioplasty in patients with acute ST-elevation myocardial infarction has been shown to be superior to fibrinolysis. Whether elderly patients have the same long-term benefit from angioplasty, compared with fibrinolysis, as younger patients is unknown. METHODS: The effect of angioplasty versus fibrinolysis was investigated in 1,572 patients from the DANAMI-2 study across age groups. End points were total mortality and a composite end point of death, reinfarction, or disabling stroke. Follow-up was 3 years. RESULTS: Increasing age was associated with mortality (adjusted hazard ratio [HR] 2.45 per 10 year increment, 95% confidence interval [CI] 1.78-3.37, P < .0001) and a higher composite event rate (adjusted HR 1.51, CI 1.26-1.82, P < .0001). The long-term superiority of angioplasty over fibrinolysis on the combined outcome was independent of age: patients aged <56 years (HR 0.73, CI 0.41-1.31); 56 to 65 years (HR 0.83, CI 0.52-1.33); 66 to 75 years (HR 0.71, CI 0.48-1.04); and >75 years (HR 0.83, CI 0.59-1.17) (P = .006 for overall treatment effect and P = .5 for interaction between age and treatment). There was no long-term effect of angioplasty versus fibrinolysis on mortality and no interaction with age (P = .5 and P for interaction = .6). CONCLUSIONS: The long-term effect of primary angioplasty compared with fibrinolysis in patients with ST-elevation myocardial infarction is not affected by age.