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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

[Catheter-based aortic valve substitution. Initial experiences with stent valve implantation].

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.

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).

[Telemedical pre-hospital diagnosis of a patient with thoracic aortic dissection].

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.

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.

Percutaneous coronary intervention for acute MI does not prevent in-hospital development of cardiogenic shock compared to fibrinolysis.

Background: It has been speculated that invasive revascularization prevents development of cardiogenic shock. Data from randomised trials comparing angioplasty with fibrinolysis on the development of cardiogenic shock are lacking.

Aims: To elucidate the effect of angioplasty on in-hospital development of cardiogenic shock compared to fibrinolysis.

[Telemedicine used for pre-hospital diagnosis of a patient with acute pulmonary embolism].

Mortality in untreated pulmonary embolism is high and short-term outcome depends on a timely diagnosis. In this case telemedicine involving 12-lead ECG and GSM-based communication between the patient in the ambulance and the telemedical staff resulted in remote pre-hospital suspicion of acute pulmonary embolism. The ambulance was referred directly to the nearest department of cardiology where acute CT and echocardiography confirmed the diagnosis.

Timing of ischemic onset estimated from the electrocardiogram is better than historical timing for predicting outcome after reperfusion therapy for acute anterior myocardial infarction: a DANish trial in Acute Myocardial Infarction 2 (DANAMI-2) substudy.

Background: Acute treatment strategy and subsequently prognosis are influenced by the duration of ischemia in patients with ST-elevation acute myocardial infarction (AMI). However, timing of ischemia may be difficult to access by patient history (historical timing) alone. We hypothesized that an electrocardiographic acuteness score is better than historical timing for predicting myocardial salvage and prognosis in patients with anterior AMI treated with fibrinolysis or primary percutaneous coronary intervention.

Does postsystolic motion or shortening predict recovery of myocardial function after primary percutanous coronary intervention?

Objective: The purpose of the study was to evaluate whether presence of postsystolic motion or shortening defined by Doppler tissue imaging may predict recovery of regional myocardial function in patients with ST-elevation myocardial infarction.

Methods: Echocardiography was performed a few hours after primary percutanous coronary intervention and at a 3-month follow-up visit in 83 patients with ST-elevation myocardial infarction. Based on visual assessment of wall thickening in a 16-segment model, segments were classified into those with: dyskinesia/akinesia (type A, n = 63) or hypokinesia (type B, n = 141) in the acute phase and no recovery of function at follow-up; dyskinesia/akinesia in the acute phase and partial recovery of function at follow-up (type C, n = 86); dyskinesia/akinesia/hypokinesia in the acute phase and complete recovery of function at follow-up (type D, n = 243); and normal myocardial function in the acute phase (type E, n = 759).